UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2009 |
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OR |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE TRANSITION PERIOD FROM TO |
COMMISSION FILE NUMBER 000-19319
VERTEX PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
MASSACHUSETTS (State or other jurisdiction of incorporation or organization) |
04-3039129 (I.R.S. Employer Identification No.) |
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130 WAVERLY STREET CAMBRIDGE, MASSACHUSETTS (Address of principal executive offices) |
02139-4242 (zip code) |
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(617) 444-6100 (Registrant's telephone number, including area code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ý | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý
Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.
Common Stock, par value $0.01 per share Class |
181,189,886 Outstanding at November 4, 2009 |
VERTEX PHARMACEUTICALS INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2009
TABLE OF CONTENTS
"We," "us," the "Company" and "Vertex" as used in this Quarterly Report on Form 10-Q refer to Vertex Pharmaceuticals Incorporated, a Massachusetts corporation, and its subsidiaries.
"Vertex" is a registered trademark of Vertex. "Agenerase," "Lexiva" and "Telzir" are registered trademarks of GlaxoSmithKline plc. "PEGASYS" is a trademark of Hoffman-La Roche. "PEGINTRON" is a registered trademark of Schering Corporation. Other brands, names and trademarks contained in this Quarterly Report on Form 10-Q are the property of their respective owners.
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share
amounts)
|
September 30, 2009 |
December 31, 2008 |
|||||||
---|---|---|---|---|---|---|---|---|---|
Assets |
|||||||||
Current assets: |
|||||||||
Cash and cash equivalents |
$ | 559,133 | $ | 389,115 | |||||
Marketable securities, available-for-sale |
297,477 | 442,986 | |||||||
Receivable related to sale of potential future milestone payments |
32,783 | | |||||||
Accounts receivable |
10,173 | 23,489 | |||||||
Prepaid expenses and other current assets |
14,500 | 11,991 | |||||||
Total current assets |
914,066 | 867,581 | |||||||
Restricted cash |
30,313 | 30,258 | |||||||
Property and equipment, net |
62,444 | 68,331 | |||||||
Intangible assets |
525,900 | | |||||||
Goodwill |
26,102 | | |||||||
Other assets |
14,666 | 14,309 | |||||||
Total assets |
$ | 1,573,491 | $ | 980,479 | |||||
Liabilities and Stockholders' Equity |
|||||||||
Current liabilities: |
|||||||||
Accounts payable |
$ | 19,962 | $ | 51,760 | |||||
Accrued expenses and other current liabilities |
108,297 | 94,203 | |||||||
Accrued interest |
855 | 5,349 | |||||||
Deferred revenues, current portion |
74,609 | 37,678 | |||||||
Accrued restructuring expense, current portion |
6,407 | 6,319 | |||||||
Other obligations |
21,236 | 21,255 | |||||||
Total current liabilities |
231,366 | 216,564 | |||||||
Accrued restructuring expense, excluding current portion |
26,951 | 27,745 | |||||||
Convertible senior subordinated notes (due February 2013) |
144,000 | 287,500 | |||||||
Secured notes (due October 2012) |
118,840 | | |||||||
Liability related to sale of potential future milestone payments |
36,160 | | |||||||
Deferred revenues, excluding current portion |
244,927 | 209,796 | |||||||
Deferred tax liability |
162,503 | | |||||||
Total liabilities |
964,747 | 741,605 | |||||||
Commitments and contingencies |
|||||||||
Stockholders' equity: |
|||||||||
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding at September 30, 2009 and December 31, 2008 |
| | |||||||
Common stock, $0.01 par value; 300,000,000 shares authorized at September 30, 2009 and December 31, 2008; 180,898,858 and 151,245,384 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively |
1,791 | 1,494 | |||||||
Additional paid-in capital |
3,138,207 | 2,281,817 | |||||||
Accumulated other comprehensive (loss) income |
(115 | ) | 3,168 | ||||||
Accumulated deficit |
(2,531,139 | ) | (2,047,605 | ) | |||||
Total stockholders' equity |
608,744 | 238,874 | |||||||
Total liabilities and stockholders' equity |
$ | 1,573,491 | $ | 980,479 | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share
amounts)
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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2009 | 2008 | 2009 | 2008 | |||||||||||
Revenues: |
|||||||||||||||
Royalty revenues |
$ | 7,834 | $ | 7,763 | $ | 19,891 | $ | 28,355 | |||||||
Collaborative and other research and development revenues |
17,123 | 23,846 | 48,109 | 114,338 | |||||||||||
Total revenues |
24,957 | 31,609 | 68,000 | 142,693 | |||||||||||
Costs and expenses: |
|||||||||||||||
Royalty expenses |
3,712 | 4,194 | 10,555 | 11,471 | |||||||||||
Research and development expenses |
132,132 | 131,728 | 415,044 | 377,574 | |||||||||||
Sales, general and administrative expenses |
36,572 | 25,430 | 97,618 | 71,810 | |||||||||||
Restructuring expense |
774 | 885 | 4,283 | 2,683 | |||||||||||
Acquisition-related expenses |
| | 7,793 | | |||||||||||
Total costs and expenses |
173,190 | 162,237 | 535,293 | 463,538 | |||||||||||
Loss from operations |
(148,233 | ) | (130,628 | ) | (467,293 | ) | (320,845 | ) | |||||||
Interest income |
595 | 4,396 | 4,683 | 12,885 | |||||||||||
Interest expense |
(1,927 | ) | (3,812 | ) | (8,630 | ) | (9,559 | ) | |||||||
Loss on exchange of convertible subordinated notes |
| | (12,294 | ) | | ||||||||||
Net loss |
$ | (149,565 | ) | $ | (130,044 | ) | $ | (483,534 | ) | $ | (317,519 | ) | |||
Basic and diluted net loss per common share |
$ | (0.84 | ) | $ | (0.93 | ) | $ | (2.86 | ) | $ | (2.30 | ) | |||
Basic and diluted weighted-average number of common shares outstanding |
178,735 | 140,109 | 169,137 | 137,788 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
|
Nine Months Ended September 30, |
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---|---|---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | ||||||||
Cash flows from operating activities: |
||||||||||
Net loss |
$ | (483,534 | ) | $ | (317,519 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||
Depreciation and amortization expense |
21,724 | 23,621 | ||||||||
Stock-based compensation expense |
68,996 | 44,150 | ||||||||
Other non-cash based compensation expense |
4,585 | 3,757 | ||||||||
Loss on disposal of property and equipment |
2,233 | | ||||||||
Loss on exchange of convertible subordinated notes |
12,294 | | ||||||||
Realized gain on marketable securities |
| (633 | ) | |||||||
Changes in operating assets and liabilities, excluding the effect of an acquisition: |
||||||||||
Accounts receivable |
13,328 | 9,354 | ||||||||
Prepaid expenses and other current assets |
(2 | ) | (6,325 | ) | ||||||
Accounts payable |
(32,104 | ) | (1,285 | ) | ||||||
Accrued expenses and other current liabilities |
(1,740 | ) | (11,174 | ) | ||||||
Accrued restructuring expense |
(706 | ) | (910 | ) | ||||||
Accrued interest |
(2,395 | ) | 1,859 | |||||||
Deferred revenues |
72,062 | 125,848 | ||||||||
Net cash used in operating activities |
(325,259 | ) | (129,257 | ) | ||||||
Cash flows from investing activities: |
||||||||||
Purchases of marketable securities |
(374,767 | ) | (508,983 | ) | ||||||
Sales and maturities of marketable securities |
517,240 | 244,777 | ||||||||
Payment for the acquisition of ViroChem, net of cash acquired |
(87,422 | ) | | |||||||
Expenditures for property and equipment |
(15,918 | ) | (25,568 | ) | ||||||
Increase in restricted cash |
(55 | ) | | |||||||
Increase in other assets |
(33 | ) | (361 | ) | ||||||
Net cash provided by (used in) investing activities |
39,045 | (290,135 | ) | |||||||
Cash flows from financing activities: |
||||||||||
Issuances of common stock from employee benefit plans, net |
24,960 | 18,351 | ||||||||
Issuances of common stock from stock offerings, net |
313,250 | 330,062 | ||||||||
Issuance of secured notes (due October 2012) |
122,217 | | ||||||||
Issuances of convertible senior subordinated notes (due February 2013), net |
| 278,607 | ||||||||
Repayment of collaborator development loan |
| (19,997 | ) | |||||||
Debt exchange costs |
(85 | ) | | |||||||
Net cash provided by financing activities |
460,342 | 607,023 | ||||||||
Effect of changes in exchange rates on cash |
(4,110 | ) | (418 | ) | ||||||
Net increase in cash and cash equivalents |
170,018 | 187,213 | ||||||||
Cash and cash equivalentsbeginning of period |
389,115 | 355,663 | ||||||||
Cash and cash equivalentsend of period |
$ | 559,133 | $ | 542,876 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||
Cash paid for interest |
$ | 10,248 | $ | 6,676 | ||||||
Exchange of convertible subordinated notes for common stock |
$ | 143,500 | $ | | ||||||
Accrued interest offset to additional paid-in capital on exchange of convertible subordinated notes |
$ | 2,099 | $ | | ||||||
Unamortized debt issuance costs of exchanged convertible subordinated notes offset to additional paid-in capital |
$ | 3,476 | $ | | ||||||
Fair value of common stock issued to acquire ViroChem |
$ | 290,557 | $ | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared by Vertex Pharmaceuticals Incorporated ("Vertex" or the "Company") in accordance with accounting principles generally accepted in the United States of America.
The condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated.
Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. The interim financial statements, in the opinion of management, reflect all normal recurring adjustments (including accruals) necessary for a fair presentation of the financial position and results of operations for the interim periods ended September 30, 2009 and 2008.
The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the fiscal year, although the Company expects to incur a substantial loss for the year ending December 31, 2009. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2008, which are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 that was filed with the Securities and Exchange Commission on February 17, 2009.
On March 12, 2009, Vertex acquired ViroChem Pharma Inc. ("ViroChem"). The Company consolidated ViroChem's operating results with those of Vertex beginning on the date of the acquisition. See Note 10, "Acquisition of ViroChem Pharma Inc.," for additional information regarding the acquisition.
The Company has evaluated subsequent events through November 9, 2009, the date of issuance of the condensed consolidated financial statements. During this period, the Company did not have any material recognizable subsequent events.
2. Accounting Policies
Reclassification in the Preparation of Financial Statements
Certain amounts in prior period condensed consolidated financial statements have been reclassified to conform to the current presentation. The reclassifications had no effect on the reported net loss.
Basic and Diluted Net Loss per Common Share
Basic net loss per common share is based upon the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method), the assumed conversion of convertible notes and vesting of unvested restricted shares of common stock. Common equivalent shares have not
5
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
2. Accounting Policies (Continued)
been included in the net loss per common share calculations because the effect would have been anti-dilutive. Total potential gross common equivalent shares consisted of the following:
|
At September 30, | |||||||
---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | ||||||
|
(in thousands, except per share amounts) |
|||||||
Stock options |
19,087 | 17,355 | ||||||
Weighted-average exercise price (per share) |
$ | 30.59 | $ | 28.71 | ||||
Convertible notes |
6,223 | 12,425 | ||||||
Conversion price (per share) |
$ | 23.14 | $ | 23.14 | ||||
Unvested restricted shares |
1,823 | 1,980 |
Stock-based Compensation Expense
The Company expenses the fair value of employee stock options and other forms of stock-based employee compensation over the employees' service periods or the derived service period for awards with market conditions. Compensation expense is determined based on the fair value of the award at the grant date, including estimated forfeitures, and is adjusted to reflect actual forfeitures and the outcomes of certain conditions. Please refer to Note 3, "Stock-based Compensation Expense," for further information.
Research and Development Expenses
All research and development expenses, including amounts funded by research and development collaborations, are expensed as incurred. The Company defers and capitalizes nonrefundable advance payments made by the Company for research and development activities until the related goods are delivered or the related services are performed.
Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in telaprevir; and infrastructure costs, including facilities costs and depreciation expense. The Company evaluates periodically whether a portion of its commercial supply investment may be capitalized as inventory. Generally, inventory may be capitalized if it is probable that future revenues will be generated from the sale of the inventory and that these revenues will exceed the cost of the inventory. The Company is continuing to expense all of its commercial supply investment due to the high risk inherent in drug development.
The Company's collaborators have funded portions of the Company's research and development programs related to specific drug candidates and research targets, including telaprevir, in the three and nine months ended September 30, 2009 and 2008. The Company's collaborative and other research and development revenues were $17.1 million and $23.8 million, respectively, for the three months ended September 30, 2009 and 2008. The Company's collaborative and other research and development revenues were $48.1 million and $114.3 million, respectively, for the nine months ended September 30,
6
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
2. Accounting Policies (Continued)
2009 and 2008. The Company's research and development expenses allocated to programs in which a collaborator funded at least a portion of the research and development expenses were approximately $33 million and approximately $41 million, respectively, for the three months ended September 30, 2009 and 2008, and approximately $119 million and approximately $111 million, respectively, for the nine months ended September 30, 2009 and 2008.
Restructuring Expense
The Company records costs and liabilities associated with exit and disposal activities based on estimates of fair value in the period the liabilities are incurred. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free discount rate applied in the initial period. Liabilities are evaluated and adjusted as appropriate at least on a quarterly basis for changes in circumstances.
Revenue Recognition
Collaborative Arrangements
The Company's revenues are generated primarily through collaborative research, development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, up-front license fees; funding of research and/or development efforts; milestone payments; and royalties on product sales.
Agreements containing multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the collaborator and whether there is objective and reliable evidence of the fair value of the undelivered obligation(s). The consideration received is allocated among the separate units either on the basis of each unit's fair value or using the residual method, and the applicable revenue recognition criteria are applied to each of the separate units.
The Company recognizes revenues from nonrefundable, up-front license fees on a straight-line basis over the contracted or estimated period of performance, which is typically the research or development term. Research and development funding is recognized as earned, ratably over the period of effort.
Substantive milestones achieved in collaboration arrangements are recognized as earned when the corresponding payment is reasonably assured, subject to the following policies in those circumstances where the Company has obligations remaining after achievement of the milestone:
7
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
2. Accounting Policies (Continued)
but the Company does not have sufficient evidence of the fair value for its remaining obligations, management considers the milestone payment and the remaining obligations under the contract as a single unit of accounting. If the collaboration does not require specific deliverables at specific times or at the end of the contract term, but rather, the Company's obligations are satisfied over a period of time, substantive milestone payments are recognized over the period of performance. This typically results in a portion of the milestone payment being recognized as revenue on the date the milestone is achieved equal to the applicable percentage of the performance period that has elapsed as of the date the milestone is achieved, with the balance being deferred and recognized over the remaining period of performance.
At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive on the basis of the contingent nature of the milestone, specifically reviewing factors such as the scientific and other risks that must be overcome to achieve the milestone, as well as the level of effort and investment required. Milestones that are not considered substantive and that do not meet the separation criteria are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance.
Payments received or reasonably assured after performance obligations are met completely are recognized as earned.
Royalty revenues typically are recognized based upon actual and estimated net sales of licensed products in licensed territories, as provided by the licensee, and generally are recognized in the period the sales occur. The Company reconciles and adjusts for differences between actual royalty revenues and estimated royalty revenues in the quarter they become known. These differences have not historically been significant.
Sale of Future Royalties
In the circumstance where the Company has sold its rights to future royalties under a license agreement and also maintains continuing involvement in the royalty arrangement (but not significant continuing involvement in the generation of the cash flows due to the purchaser), the Company defers recognition of the proceeds it receives for the royalty stream and recognizes these deferred revenues over the life of the license agreement. The Company recognizes these deferred revenues pursuant to the units-of-revenue method. Under this method, the amount of deferred revenues to be recognized as royalty revenues in each period is calculated by multiplying the following: (1) the royalty payments due to the purchaser for the period by (2) the ratio of the remaining deferred revenue amount to the total estimated remaining royalty payments due to the purchaser over the term of the agreement.
Debt and Financing Issuance Costs and Royalty Sale Transaction Expenses
Issuance costs incurred to complete the Company's convertible senior subordinated note offering and the financial transactions that the Company entered into in September 2009 are deferred and included in other assets on the condensed consolidated balance sheets. The issuance costs are amortized using the effective interest rate method over the term of the related debt or financing instrument. The amortization expense related to the issuance costs is included in interest expense on the condensed consolidated statements of operations.
8
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
2. Accounting Policies (Continued)
The Company defers direct and incremental costs associated with the sale of its rights to future HIV royalties. These costs are included in other assets on the condensed consolidated balance sheets and are amortized in the same manner and over the same period in which the related deferred revenues are recognized as royalty revenues. The amortization expense related to these transaction expenses is included in royalty expenses on the condensed consolidated statements of operations.
Business Combinations
The Company assigns the value of the consideration transferred to acquire a business to the tangible assets and identifiable intangible assets acquired and liabilities assumed on the basis of their fair values at the date of acquisition. The Company assesses the fair value of assets, including intangible assets such as in-process research and development, using a variety of methods including present-value models. Each asset is measured at fair value from the perspective of a market participant. The method used to estimate the fair values of in-process research and development assets incorporates significant assumptions regarding the estimates a market participant would make in order to evaluate an asset, including a market participant's assumptions regarding the probability of completing in-process research and development projects, which would require obtaining regulatory approval for marketing of the associated drug candidate; a market participant's estimates regarding the timing of and the expected costs to complete in-process research and development projects; a market participant's estimates of future cash flows from potential product sales; and the appropriate discount rates for a market participant. Transaction costs and restructuring costs associated with the transaction are expensed as incurred.
In-process Research and Development Assets
In-process research and development assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite-lived intangible assets. These assets are maintained on the Company's condensed consolidated balance sheets until either the project underlying them is completed or the assets become impaired. If a project is completed, the carrying value of the related intangible asset is amortized over the remaining estimated life of the asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs. In-process research and development assets will be tested for impairment on an annual basis during the fourth quarter, or earlier if impairment indicators are present.
Goodwill
The difference between the purchase price and the fair value of assets acquired and liabilities assumed in a business combination is allocated to goodwill. Goodwill will be evaluated for impairment on an annual basis during the fourth quarter, or earlier if impairment indicators are present.
Derivative Instruments and Embedded Derivatives
The Company has entered into financial transactions involving a free-standing derivative instrument and embedded derivatives. The embedded derivatives are required to be bifurcated from the
9
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
2. Accounting Policies (Continued)
host instruments because the derivatives are not clearly and closely related to the host instruments. These financial transactions include transactions involving convertible notes, secured notes and the sale of potential future milestone payments. The Company determines the fair value of each derivative instrument or embedded derivative on the date of issuance. The estimates of the fair value of these derivatives, particularly with respect to derivatives related to the achievement of milestones in the development of specific drug candidates, include significant assumptions regarding the estimates a market participant would make in order to evaluate the asset. Changes in the fair value of these instruments are evaluated on at least a quarterly basis. Please refer to Note 13, "September 2009 Financial Transactions," for further information.
3. Stock-based Compensation Expense
At September 30, 2009, the Company had four stock-based employee compensation plans: the 1991 Stock Option Plan (the "1991 Plan"), the 1994 Stock and Option Plan (the "1994 Plan"), the 1996 Stock and Option Plan (the "1996 Plan") and the 2006 Stock and Option Plan (the "2006 Plan" and together with the 1991 Plan, the 1994 Plan and the 1996 Plan, collectively, the "Stock and Option Plans") and one Employee Stock Purchase Plan (the "ESPP"). On May 15, 2008, the Company's stockholders approved an increase in the number of shares of common stock authorized for issuance under the 2006 Plan of 6,600,000, to a total of 13,902,380 shares of common stock, and an increase in the number of shares of common stock authorized for issuance under the ESPP of 2,000,000. On May 14, 2009, the Company's stockholders approved an increase in the number of shares of common stock authorized for issuance under the 2006 Plan of 7,700,000, to a total of 21,602,380 shares of common stock. In connection with the Stock and Option Plans, the Company issues stock options and restricted stock awards with service conditions, which are generally the vesting periods of the awards. The Company also issues to certain members of senior management restricted stock awards that vest upon the earlier of the satisfaction of (i) a market or performance condition or (ii) a service condition ("PARS").
The Company recognizes share-based payments to employees as compensation expense using the fair value method. The fair value of stock options and shares purchased pursuant to the ESPP is calculated using the Black-Scholes valuation model. The fair value of restricted stock awards typically is based on intrinsic value on the date of grant. Stock-based compensation, measured at the grant date based on the fair value of the award, is recognized as expense ratably over the service period. The expense recognized over the service period includes an estimate of awards that will be forfeited.
For PARS awards granted in 2008, 2007 and 2006, which vest upon the earlier of the achievement of a market condition or a service condition, a portion of the fair value of the common stock on the date of grant is recognized ratably over a derived service period that is equal to the estimated time to satisfy the market condition. The portion of the fair value of the common stock that is recognized over the derived service period is determined on the basis of the estimated probability that the PARS award will vest as a result of satisfying the market condition. For the PARS awards granted in 2008, 2007 and 2006, the derived service period relating to each market condition is shorter than the four-year service-based vesting period of the PARS. The difference between the fair value of the common stock on the date of grant and the value recognized over the derived service period is recognized ratably over the four-year service-based vesting period of the PARS. The stock-based compensation expense recognized
10
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
3. Stock-based Compensation Expense (Continued)
over each of the derived service periods and the four-year service periods includes an estimate of awards that will be forfeited prior to the end of the derived service periods or the four-year service periods, respectively. For PARS awards granted in 2009, the shares vest on the fourth anniversary of the grant date, subject to accelerated vesting upon achievement of performance conditions. Stock-based compensation expense associated with the PARS issued in 2009 is being expensed ratably over the four-year service period.
The effect of stock-based compensation expense during the three and nine months ended September 30, 2009 and 2008 was as follows:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | 2009 | 2008 | ||||||||||
|
(in thousands) |
|||||||||||||
Stock-based compensation expense by type of award: |
||||||||||||||
Stock options |
$ | 14,180 | $ | 9,874 | $ | 51,044 | $ | 29,901 | ||||||
Restricted stock (including PARS) |
4,901 | 3,649 | 14,606 | 11,574 | ||||||||||
ESPP issuances |
1,053 | 962 | 3,346 | 2,675 | ||||||||||
Total stock-based compensation expense |
$ | 20,134 | $ | 14,485 | $ | 68,996 | $ | 44,150 | ||||||
Effect of stock-based compensation expense by line item: |
||||||||||||||
Research and development expenses |
$ | 13,048 | $ | 11,423 | $ | 50,942 | $ | 35,392 | ||||||
Sales, general and administrative expenses |
7,086 | 3,062 | 18,054 | 8,758 | ||||||||||
Total stock-based compensation expense included in net loss |
$ | 20,134 | $ | 14,485 | $ | 68,996 | $ | 44,150 | ||||||
Stock Options
All stock options awarded during the nine months ended September 30, 2009 and 2008 were awarded with exercise prices equal to the fair market value of the Company's common stock on the date the award was granted by the Company's board of directors. Under amendments to the 2006 Plan adopted on May 15, 2008, no options can be issued under the 2006 Plan with an exercise price less than the fair market value on the date of grant.
The stock options granted during the nine months ended September 30, 2008 included options to purchase 536,625 shares of common stock (the "Contingent Options") at an exercise price of $18.93 per share that were granted to the Company's executive officers on February 7, 2008, subject to ratification by the Company's stockholders. At the Company's 2008 Annual Meeting of Stockholders, the stockholders ratified the Contingent Options as part of the Company's proposal to increase the number of shares authorized for issuance under the 2006 Plan. The Contingent Options are deemed for accounting purposes to have been granted on May 15, 2008 (the date of ratification by the Company's stockholders), and the grant-date fair value of the Contingent Options is based on a Black-Scholes valuation model based on the fair market value of the Contingent Options on May 15, 2008.
11
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
3. Stock-based Compensation Expense (Continued)
The options granted during the three and nine months ended September 30, 2009 had a weighted-average grant-date fair value per share of $18.37 and $18.51, respectively. The options granted during the three and nine months ended September 30, 2008 had a weighted-average grant-date fair value per share of $16.97 and $14.33, respectively.
The Company recorded stock-based compensation expense related to stock options of $14.2 million and $9.9 million, respectively, for the three months ended September 30, 2009 and 2008. The Company recorded stock-based compensation expense related to stock options of $51.0 million and $29.9 million, respectively, for the nine months ended September 30, 2009 and 2008. The stock-based compensation expense related to stock options for the three and nine months ended September 30, 2009 included $2.0 million and $12.7 million, respectively, related to stock options that were accelerated and modified in connection with transition arrangements and severance arrangements with certain of the Company's former executive officers. As of September 30, 2009, there was $99.4 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to unvested options granted under the Company's Stock and Option Plans. That expense is expected to be recognized over a weighted-average period of 2.84 years.
Restricted Stock
The Company recorded stock-based compensation expense of $4.9 million and $3.6 million, respectively, for the three months ended September 30, 2009 and 2008, and $14.6 million and $11.6 million, respectively, for the nine months ended September 30, 2009 and 2008 related to restricted stock, including PARS, outstanding during those periods. The stock-based compensation expense related to restricted stock, including PARS, for the three and nine months ended September 30, 2009 included $0.6 million and $2.2 million, respectively, related to accelerated vesting of restricted stock awards in connection with transition arrangements and severance arrangements with certain of the Company's former executive officers. The stock-based compensation expense for restricted stock for the nine months ended September 30, 2008 included $0.6 million related to accelerated vesting of restricted stock awards in connection with an executive officer's separation from the Company.
As of September 30, 2009, there was $34.3 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to unvested restricted stock, including PARS, granted under the Company's Stock and Option Plans. That expense is expected to be recognized over a weighted-average period of 2.68 years.
Employee Stock Purchase Plan
The stock-based compensation expense related to the ESPP was $1.1 million and $1.0 million, respectively, for the three months ended September 30, 2009 and 2008 and $3.3 million and $2.7 million, respectively, for the nine months ended September 30, 2009 and 2008. As of September 30, 2009, there was $1.1 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to ESPP shares. That expense is expected to be recognized during the nine month period ending June 30, 2010.
12
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
3. Stock-based Compensation Expense (Continued)
During the nine months ended September 30, 2009, the Company issued 208,000 shares to employees under the ESPP at an average price paid of $23.07 per share. During the nine months ended September 30, 2008, the Company issued 185,000 shares to employees under the ESPP at an average price paid of $22.55 per share. There were no shares issued to employees under the ESPP during the three months ended September 30, 2009 and 2008.
4. Marketable Securities
A summary of cash, cash equivalents and marketable securities is shown below:
September 30, 2009
|
Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair Value |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
(in thousands) |
|||||||||||||
Cash and cash equivalents |
||||||||||||||
Cash and money market funds |
$ | 553,053 | $ | | $ | | $ | 553,053 | ||||||
Government-sponsored enterprise securities |
6,082 | | (2 | ) | 6,080 | |||||||||
Total cash and cash equivalents |
$ | 559,135 | $ | | $ | (2 | ) | $ | 559,133 | |||||
Marketable securities |
||||||||||||||
Government-sponsored enterprise securities (due within 1 year) |
$ | 297,376 | $ | 109 | $ | (8 | ) | $ | 297,477 | |||||
Total marketable securities |
$ | 297,376 | $ | 109 | $ | (8 | ) | $ | 297,477 | |||||
Total cash, cash equivalents and marketable securities |
$ | 856,511 | $ | 109 | $ | (10 | ) | $ | 856,610 | |||||
December 31, 2008 |
||||||||||||||
Cash and cash equivalents |
||||||||||||||
Cash and money market funds |
$ | 389,115 | $ | | $ | | $ | 389,115 | ||||||
Total cash and cash equivalents |
$ | 389,115 | $ | | $ | | $ | 389,115 | ||||||
Marketable securities |
||||||||||||||
Government-sponsored enterprise securities (due within 1 year) |
$ | 347,982 | $ | 2,713 | $ | | $ | 350,695 | ||||||
Corporate debt securities (due within 1 year) |
91,863 | 428 | | 92,291 | ||||||||||
Total marketable securities |
$ | 439,845 | $ | 3,141 | $ | | $ | 442,986 | ||||||
Total cash, cash equivalents and marketable securities |
$ | 828,960 | $ | 3,141 | $ | | $ | 832,101 | ||||||
The Company had marketable securities of $297.5 million and $443.0 million that were all classified as current assets on the condensed consolidated balance sheets as of September 30, 2009 and December 31, 2008, respectively.
The Company reviews investments in marketable securities for other-than-temporary impairment whenever the fair value of an investment is less than amortized cost and evidence indicates that an investment's carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers the intent to sell, or whether it is more likely than not that the Company will be required to sell, the investment before recovery of the investment's amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company's investment policy, the severity and the duration of the impairment and changes in value subsequent to period end. As of September 30, 2009, the Company
13
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
4. Marketable Securities (Continued)
had one government-sponsored enterprise security that was in an unrealized loss position of $2,000 and five government-sponsored enterprise securities that were in an unrealized loss position of $8,000. As of December 31, 2008, the Company did not have any securities with unrealized losses.
In the three and nine months ended September 30, 2009, the Company had proceeds of $171.8 million and $517.2 million, respectively, from sales and maturities of available-for-sale securities. In the three and nine months ended September 30, 2008, the Company had proceeds of $160.4 million and $244.8 million, respectively, from sales and maturities of available-for-sale securities.
Realized gains and losses are determined using the specific identification method and are included in interest income on the condensed consolidated statements of operations. There were no gross realized gains and losses for the three and nine months ended September 30, 2009. Gross realized gains and losses for the three months ended September 30, 2008 were $418,000 and $4,000, respectively. Gross realized gains and losses for the nine months ended September 30, 2008 were $943,000 and $310,000, respectively.
5. Fair Value of Financial Instruments and Nonfinancial Assets
The fair value of the Company's financial assets and liabilities reflects the Company's estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company's assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities:
Level 1: | Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. | |||
Level 2: |
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. |
|||
Level 3: |
Unobservable inputs based on the Company's assessment of the assumptions that market participants would use in pricing the asset or liability. |
The Company's investment strategy is focused on capital preservation. The Company invests in instruments that meet credit quality standards as outlined in the Company's investment policy guidelines. These guidelines also limit the amount of credit exposure to any one issue or type of instrument. Beginning in the fourth quarter of 2007, the Company began to shift its investments to instruments that carry less exposure to market volatility and liquidity pressures. As of September 30, 2009, the Company's investments are in money market funds and short-term government guaranteed or supported securities.
14
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
5. Fair Value of Financial Instruments and Nonfinancial Assets (Continued)
As of September 30, 2009, all of the Company's financial assets that were subject to fair value measurements were valued using observable inputs. The Company's financial assets valued based on Level 1 inputs consisted of a money market fund and government-sponsored enterprise securities, which are government-supported. The Company's money market fund also invests in government-sponsored enterprise securities. The Company's financial liabilities that were subject to fair value measurement related to the financial transactions that the Company entered into in September 2009 are valued based on Level 3 inputs. Please refer to Note 13, "September 2009 Financial Transactions." During the nine months ended September 30, 2009 and 2008, the Company did not record an other-than-temporary impairment charge related to its investments.
The following table sets forth the Company's financial assets and liabilities subject to fair value measurements as of the end of the third quarter of 2009:
|
Fair Value Measurements as of September 30, 2009 |
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
Fair Value Hierarchy | |||||||||||||
|
Total | Level 1 | Level 2 | Level 3 | |||||||||||
|
(in thousands) |
||||||||||||||
Financial assets carried at fair value: |
|||||||||||||||
Cash equivalents |
$ | 535,384 | $ | 535,384 | $ | | $ | | |||||||
Marketable securities, available-for-sale |
297,477 | 297,477 | | | |||||||||||
Restricted cash |
30,313 | 30,313 | | | |||||||||||
Total |
$ | 863,174 | $ | 863,174 | $ | | $ | | |||||||
Financial liabilities carried at fair value: |
|||||||||||||||
Embedded derivative related to 2012 Notes |
$ | 10,652 | $ | | $ | | $ | 10,652 | |||||||
Liability related to sale of potential future milestone payments |
36,160 | | | 36,160 | |||||||||||
Total |
$ | 46,812 | $ | | $ | | $ | 46,812 | |||||||
Intangible assets acquired in connection with the Company's acquistion of ViroChem were accounted for as described in Note 10, "Acquisition of ViroChem Pharma Inc." The estimated fair value of these nonfinancial assets was based on Level 3 inputs.
The Company had $144.0 million outstanding in aggregate principal amount of 4.75% convertible senior subordinated notes due 2013 included on the condensed consolidated balance sheet as of September 30, 2009. At September 30, 2009, these 2013 Notes had a fair value of $238.1 million as obtained from a quoted market source.
15
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
6. Comprehensive Loss
For the three and nine months ended September 30, 2009 and 2008, comprehensive loss was as follows:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | 2009 | 2008 | ||||||||||
|
(in thousands) |
|||||||||||||
Net loss |
$ | (149,565 | ) | $ | (130,044 | ) | $ | (483,534 | ) | $ | (317,519 | ) | ||
Changes in other comprehensive income (loss): |
||||||||||||||
Unrealized holding gains (losses) on marketable securities |
(206 | ) | 823 | (3,042 | ) | 1,455 | ||||||||
Reclassification adjustment for realized gain on marketable securities included in net loss |
| (414 | ) | | (1,243 | ) | ||||||||
Foreign currency translation adjustment |
(327 | ) | (381 | ) | (241 | ) | (418 | ) | ||||||
Total change in other comprehensive income (loss) |
(533 | ) | 28 | (3,283 | ) | (206 | ) | |||||||
Total comprehensive loss |
$ | (150,098 | ) | $ | (130,016 | ) | $ | (486,817 | ) | $ | (317,725 | ) | ||
7. Income Taxes
At September 30, 2009 and December 31, 2008, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations were required pursuant to the applicable accounting interpretation regarding accounting for uncertainty in income taxes. The Company does not expect that its unrecognized tax benefits will materially increase within the next twelve months. The Company did not recognize any material interest or penalties related to uncertain tax positions at September 30, 2009 and December 31, 2008.
The Company files United States federal income tax returns and income tax returns in various state, local, and foreign jurisdictions. The Company is no longer subject to any tax assessment from an income tax examination in the United States before 2007 and any other major taxing jurisdiction for years before 2005, except where the Company has net operating losses or tax credit carryforwards that originate before 2005. The Company completed an examination by the Internal Revenue Service with respect to 2006 in June 2009 with no material change. The Company currently is not under examination by any jurisdiction for any tax year.
8. Restructuring Expense
In June 2003, Vertex adopted a plan to restructure its operations to coincide with its increasing internal emphasis on advancing drug candidates through clinical development to commercialization. The restructuring was designed to re-balance the Company's relative investments in research and development to better support the Company's long-term strategy. The restructuring plan included a workforce reduction, write-offs of certain assets and a decision not to occupy approximately 290,000 square feet of specialized laboratory and office space in Cambridge, Massachusetts under lease to Vertex (the "Kendall Square Lease"). The Kendall Square Lease commenced in January 2003 and has a 15-year term. In the second quarter of 2005, the Company revised its assessment of its real estate requirements and decided to use approximately 120,000 square feet of the facility subject to the Kendall Square Lease (the "Kendall Square Facility") for its operations, beginning in 2006. The remaining rentable square footage of the Kendall Square Facility currently is subleased to third parties.
16
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
8. Restructuring Expense (Continued)
The restructuring expense incurred in the three and nine months ended September 30, 2009 and 2008 relates only to the portion of the building that the Company is not occupying and does not intend to occupy for its operations. The remaining lease obligations, which are associated with the portion of the Kendall Square Facility that the Company occupies and uses for its operations, are recorded as rental expense in the period incurred.
In estimating the expense and liability under its Kendall Square Lease obligation, the Company estimated (i) the costs to be incurred to satisfy rental and build-out commitments under the lease (including operating costs), (ii) the lead-time necessary to sublease the space, (iii) the projected sublease rental rates and (iv) the anticipated durations of subleases. The Company uses a credit-adjusted risk-free rate of approximately 10% to discount the estimated cash flows. The Company reviews its estimates and assumptions on at least a quarterly basis, and intends to continue such reviews until the termination of the Kendall Square Lease, and will make whatever modifications the Company believes necessary, based on the Company's best judgment, to reflect any changed circumstances. The Company's estimates have changed in the past, and may change in the future, resulting in additional adjustments to the estimate of the liability, and the effect of any such adjustments could be material. Changes to the Company's estimate of the liability are recorded as additional restructuring expense/(credit). In addition, because the Company's estimate of the liability includes the application of a discount rate to reflect the time-value of money, the Company will record imputed interest costs related to the liability each quarter. These costs are included in restructuring expense on the Company's condensed consolidated statements of operations.
For the three months ended September 30, 2009, the Company recorded restructuring expense of $0.8 million, which was primarily the result of the imputed interest cost relating to the restructuring liability. The activity related to the restructuring liability for the three months ended September 30, 2009 was as follows (in thousands):
|
Liability as of June 30, 2009 |
Cash payments in the third quarter of 2009 |
Cash received from subleases in the third quarter of 2009 |
Charge in the third quarter of 2009 |
Liability as of September 30, 2009 |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lease restructuring liability |
$ | 34,050 | $ | (3,772 | ) | $ | 2,306 | $ | 774 | $ | 33,358 | |||||
17
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
8. Restructuring Expense (Continued)
For the three months ended September 30, 2008, the Company recorded restructuring expense of $0.9 million, which was primarily the result of the imputed interest cost relating to the restructuring liability. The activity related to the restructuring liability for the three months ended September 30, 2008 was as follows (in thousands):
|
Liability as of June 30, 2008 |
Cash payments in the third quarter of 2008 |
Cash received from subleases in the third quarter of 2008 |
Charge in the third quarter of 2008 |
Liability as of September 30, 2008 |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lease restructuring liability |
$ | 34,490 | $ | (3,597 | ) | $ | 2,604 | $ | 885 | $ | 34,382 | |||||
For the nine months ended September 30, 2009, the Company recorded restructuring expense of $4.3 million, which was the result of incremental lease obligations related to the revision of certain key estimates and assumptions about facility operating costs as well as the imputed interest cost relating to the restructuring liability. The activity related to the restructuring liability for the nine months ended September 30, 2009 was as follows (in thousands):
|
Liability as of December 31, 2008 |
Cash payments in the first nine months of 2009 |
Cash received from subleases in the first nine months of 2009 |
Charge in the first nine months of 2009 |
Liability as of September 30, 2009 |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lease restructuring liability |
$ | 34,064 | $ | (11,529 | ) | $ | 6,540 | $ | 4,283 | $ | 33,358 | |||||
For the nine months ended September 30, 2008, the Company recorded restructuring expense of $2.7 million, which was primarily the result of the imputed interest cost relating to the restructuring liability. The activity related to the restructuring liability for the nine months ended September 30, 2008 was as follows (in thousands):
|
Liability as of December 31, 2007 |
Cash payments in the first nine months of 2008 |
Cash received from subleases in the first nine months of 2008 |
Charge in the first nine months of 2008 |
Liability as of September 30, 2008 |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lease restructuring liability |
$ | 35,292 | $ | (10,430 | ) | $ | 6,837 | $ | 2,683 | $ | 34,382 | |||||
18
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
9. Equity and Debt Offerings and Debt Exchanges
On February 24, 2009, the Company completed an offering of 10,000,000 shares of common stock (the "February 2009 Equity Offering"), which were sold at a price of $32.00 per share. This offering resulted in $313.3 million of net proceeds to the Company. The underwriting discount of $6.4 million and other expenses of $0.4 million related to the February 2009 Equity Offering were recorded as an offset to additional paid-in capital.
On September 23, 2008, the Company completed an offering of 8,625,000 shares of common stock (the "September 2008 Equity Offering"), which were sold at a price of $25.50 per share. This offering resulted in $217.4 million of net proceeds to the Company. The underwriting discount of $2.2 million and other expenses of $0.3 million related to the September 2008 Equity Offering were recorded as an offset to additional paid-in capital.
On February 19, 2008, the Company completed concurrent offerings of $287.5 million in aggregate principal amount of 4.75% convertible senior subordinated notes due 2013 (the "2013 Notes") and 6,900,000 shares of common stock (the "February 2008 Equity Offering"), which were sold at a price of $17.14 per share.
The convertible debt offering resulted in net proceeds of $278.6 million to the Company. The underwriting discount of $8.6 million and other expenses of $0.3 million related to the convertible debt offering were recorded as debt issuance costs and are included in other assets on the Company's condensed consolidated balance sheets. The February 2008 Equity Offering resulted in net proceeds of $112.7 million to the Company. The underwriting discount of $5.3 million and other expenses of $0.2 million related to the February 2008 Equity Offering were recorded as an offset to additional paid-in capital.
The 2013 Notes are convertible, at the option of the holder, into common stock at a price equal to approximately $23.14 per share, subject to adjustment. The 2013 Notes bear interest at the rate of 4.75% per annum, and the Company is required to make semi-annual interest payments on the outstanding principal balance of the 2013 Notes on February 15 and August 15 of each year. The 2013 Notes will mature on February 15, 2013.
On or after February 15, 2010, the Company may redeem the 2013 Notes at its option, in whole or in part, at the redemption prices stated in the indenture, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. Holders may require the Company to repurchase some or all of their 2013 Notes upon the occurrence of certain fundamental changes of Vertex, as set forth in the indenture, at 100% of the principal amount of the 2013 Notes to be repurchased, plus any accrued and unpaid interest, if any, to, but excluding, the repurchase date.
If a fundamental change occurs that is also a specific type of change of control under the indenture, the Company will pay a make-whole premium upon the conversion of the 2013 Notes in connection with any such transaction by increasing the applicable conversion rate on such 2013 Notes. The make-whole premium will be in addition to, and not in substitution for, any cash, securities or other assets otherwise due to holders of the 2013 Notes upon conversion. The make-whole premium will be determined by reference to the indenture and is based on the date on which the fundamental change becomes effective and the price paid, or deemed to be paid, per share of the Company's common stock in the transaction constituting the fundamental change, subject to adjustment.
19
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
9. Equity and Debt Offerings and Debt Exchanges (Continued)
The indenture provides the holders of the 2013 Notes with certain remedies if a default occurs under the indenture. If an event of default under the indenture relates solely to the Company's failure to comply with its reporting obligations pursuant to the 2013 Notes, at the election of the Company, the sole remedy of the holders of the 2013 Notes for the first 180 days following such event of default would consist of the right to receive special interest at an annual rate equal to 1.0% of the outstanding principal amount of the 2013 Notes.
Based on the Company's evaluation of the 2013 Notes, the Company determined that the 2013 Notes contain a single embedded derivative. This embedded derivative relates to potential penalty interest payments that could be imposed on the Company for a failure to comply with its reporting obligations pursuant to the 2013 Notes. This embedded derivative required bifurcation as the feature was not clearly and closely related to the host instrument. The Company has determined that the value of this embedded derivative was nominal as of February 19, 2008, December 31, 2008 and September 30, 2009.
On June 10, 2009, the Company exchanged 6,601,000 shares of newly-issued common stock for $143.5 million in aggregate principal amount of the 2013 Notes, plus accrued interest. In the exchanges, the Company issued 46 shares of common stock for each $1,000 in principal amount of 2013 Notes. As a result of the exchanges, the Company incurred a non-cash charge of $12.3 million in the second quarter of 2009. This charge is related to the incremental shares issued in the transaction over the number that would have been issued upon conversion of the 2013 Notes under their original terms, at the original conversion rate of approximately 43.22 shares of common stock per $1,000 in principal amount of the 2013 Notes. In addition, accrued interest of $2.1 million and unamortized debt issuance costs of exchanged convertible notes of $3.5 million were recorded as an offset to additional paid-in capital on the Company's condensed consolidated balance sheet.
10. Acquisition of ViroChem Pharma Inc.
On March 12, 2009, the Company acquired 100% of the outstanding equity of ViroChem, a privately-held biotechnology company based in Canada, for $100.0 million in cash and 10,733,527 shares of the Company's common stock. Vertex acquired ViroChem in order to add two clinical-development stage HCV polymerase inhibitors to Vertex's HCV drug development portfolio. In addition at the time of the acquisition, ViroChem was engaged in additional research stage activities related to viral diseases and was developing an early-stage drug candidate for the treatment of patients with HIV.
The transaction is being accounted for under the acquisition method of accounting. All of the assets acquired and liabilities assumed in the transaction are recognized at their acquisition-date fair values, while transaction costs and restructuring costs associated with the transaction are expensed as incurred.
Purchase Price
The $390.6 million purchase price for ViroChem is based on the acquisition-date fair value of the consideration transferred, which was calculated based on the opening price of the Company's common
20
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
10. Acquisition of ViroChem Pharma Inc. (Continued)
stock of $27.07 per share on March 12, 2009. The acquisition-date fair value of the consideration consisted of the following:
|
Fair Value of Consideration |
||||
---|---|---|---|---|---|
|
(in thousands) |
||||
Cash |
$ | 100,000 | |||
Common stock |
290,557 | ||||
Total |
$ | 390,557 | |||
Allocations of Assets and Liabilities
The Company has allocated the purchase price for ViroChem to net tangible assets and intangible assets, goodwill and a deferred tax liability. The difference between the aggregate purchase price and the fair value of assets acquired and liabilities assumed was allocated to goodwill. The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date:
|
Fair Values as of March 12, 2009 |
||||
---|---|---|---|---|---|
|
(in thousands) |
||||
Cash and cash equivalents |
$ | 12,578 | |||
Other tangible assets |
2,701 | ||||
Intangible assets |
525,900 | ||||
Goodwill |
26,102 | ||||
Accounts payable and accrued expenses |
(14,221 | ) | |||
Deferred tax liability |
(162,503 | ) | |||
Net assets |
$ | 390,557 | |||
All $525.9 million of the intangible assets acquired in the ViroChem acquisition relate to in-process research and development assets. These in-process research and development assets primarily relate to ViroChem's two clinical-development stage HCV polymerase inhibitors, VX-222 (formerly VCH-222) and VX-759 (formerly VCH-759), which had estimated fair values of $412.9 million and $105.8 million, respectively. The fair values of VX-222 and VX-759 were measured from the perspective of a market participant. In addition, the Company considered ViroChem's other clinical drug candidates and determined that VCH-286, ViroChem's lead HIV drug candidate, had an estimated fair value of $7.2 million, based on development costs through the acquisition date, and that the other clinical drug candidates had no fair value because the clinical and non-clinical data for those drug candidates did not support further development as of the acquisition date. The Company also considered ViroChem's preclinical programs and other technologies and determined that because of uncertainties related to the safety, efficacy and commercial viability of the potential drug candidates, market participants would not ascribe value to these assets.
If a project is completed, the carrying value of the related intangible asset will be amortized over the remaining estimated life of the asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset will be written down to its fair value and an impairment charge will be taken in the period in which the
21
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
10. Acquisition of ViroChem Pharma Inc. (Continued)
impairment occurs. The ViroChem intangible assets will be tested for impairment on an annual basis during the fourth quarter, or earlier if impairment indicators are present.
The deferred tax liability primarily relates to the tax impact of future amortization or impairments associated with the identified intangible assets acquired, which are not deductible for tax purposes.
The difference between the consideration transferred to acquire the business and the fair value of assets acquired and liabilities assumed was allocated to goodwill. This goodwill relates to the potential synergies from the possible development of combination therapies involving telaprevir and the acquired drug candidates. None of the goodwill is expected to be deductible for income tax purposes. During the third quarter of 2009, goodwill was reduced and other tangible assets were increased by $781,000 as a result of an adjustment to ViroChem's balance sheet that was recorded as of the acquisition date.
Acquisition-related Expenses, Including Restructuring
The Company incurred $0 and $7.8 million, respectively, in expenses that are reflected as acquisition-related expenses on the condensed consolidated statements of operations for the three and nine months ended September 30, 2009. These costs include transaction expenses and a restructuring charge that was incurred in March 2009 when Vertex determined it would restructure ViroChem's operations in order to focus ViroChem's activities on its HCV development programs. As a result of this restructuring plan, Vertex recorded a $2.1 million expense related to employee severance, benefits and related costs in the first quarter of 2009 when the liability was incurred. The accrued liability of $2.1 million, which was included in accrued expenses and other current liabilities on the condensed consolidated balance sheet as of March 31, 2009, was paid in the second quarter of 2009.
ViroChem Financial Information
The results of operations of ViroChem have been included in the condensed consolidated financial statements since the acquisition date. ViroChem had no revenues in the period from the acquisition date to September 30, 2009, and ViroChem's net loss in the period from the acquisition date to September 30, 2009 was immaterial to the Company's condensed consolidated financial results. Pro forma results of operations for the three and nine months ended September 30, 2009 and 2008 assuming the acquisition of ViroChem had taken place at the beginning of each period would not differ significantly from Vertex's actual reported results.
11. Sale of HIV Protease Inhibitor Royalty Stream
In December 1993, the Company and GlaxoSmithKline plc ("GlaxoSmithKline") entered into a collaboration agreement to research, develop and commercialize HIV protease inhibitors, including Agenerase (amprenavir) and Lexiva/Telzir (fosamprenavir calcium). Under the collaboration agreement, GlaxoSmithKline agreed to pay the Company royalties on net sales of drugs developed under the collaboration.
The Company began earning a royalty from GlaxoSmithKline in 1999 on net sales of Agenerase, in the fourth quarter of 2003 on net sales of Lexiva, and in the third quarter of 2004 on net sales of Telzir. GlaxoSmithKline has the right to terminate its arrangement with the Company without cause upon twelve months' notice. Termination of the collaboration agreement by GlaxoSmithKline will relieve it of its obligation to make further payments under the agreement and will end any license
22
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
11. Sale of HIV Protease Inhibitor Royalty Stream (Continued)
granted to GlaxoSmithKline by the Company under the agreement. In June 1996, the Company and GlaxoSmithKline obtained a worldwide, non-exclusive license under certain G.D. Searle & Co. ("Searle," now owned by Pharmacia/Pfizer) patents in the area of HIV protease inhibition. Searle is paid royalties based on net sales of Agenerase and Lexiva/Telzir.
On May 30, 2008, the Company entered into a purchase agreement (the "Purchase Agreement") with Fosamprenavir Royalty, L.P. ("Fosamprenavir Royalty") pursuant to which the Company sold, and Fosamprenavir Royalty purchased, the Company's right to receive royalty payments, net of royalty amounts to be earned and due to Searle, arising from sales of Lexiva/Telzir and Agenerase under the Company's 1993 agreement with GlaxoSmithKline, from April 1, 2008 to the end of the term of the collaboration agreement, for a one-time cash payment of $160.0 million. In accordance with the Purchase Agreement, GlaxoSmithKline will make all royalty payments, net of the subroyalty amounts payable to Searle, directly to Fosamprenavir Royalty. The Purchase Agreement also contains other representations, warranties, covenants and indemnification obligations. The Company continues to be obligated for royalty amounts earned and that are due to Searle. The Company has instructed GlaxoSmithKline to pay such amounts directly to Searle as they become due.
The Company classified the proceeds received from Fosamprenavir Royalty as deferred revenues, to be recognized as royalty revenues over the life of the collaboration agreement, because of the Company's continuing involvement in the royalty arrangement over the term of the Purchase Agreement. Such continuing involvement, which is required pursuant to covenants contained in the Purchase Agreement, includes overseeing GlaxoSmithKline's compliance with the collaboration agreement, monitoring and defending patent infringement, adverse claims or litigation involving the royalty stream, undertaking to cooperate with Fosamprenavir Royalty's efforts to find a new license partner if GlaxoSmithKline terminates the collaboration agreement, and complying with the license agreement with Searle, including the obligation to make future royalty payments to Searle. Because the transaction was structured as a non-cancellable sale, the Company has no significant continuing involvement in the generation of the cash flows due to Fosamprenavir Royalty and there are no guaranteed rates of return to Fosamprenavir Royalty, the Company has recorded the proceeds as deferred revenues.
The Company recorded $155.1 million, representing the proceeds of the transaction less the net royalty payable to Fosamprenavir Royalty for the period from April 1, 2008 through May 30, 2008, as deferred revenues to be recognized as royalty revenues over the life of the collaboration agreement based on the units-of-revenue method. The amount of deferred revenues to be recognized as royalty revenues in each period is calculated by multiplying the following: (1) the net royalty payments due to Fosamprenavir Royalty for the period by (2) the ratio of the remaining deferred revenue amount to the total estimated remaining net royalties that GlaxoSmithKline is expected to pay Fosamprenavir Royalty over the term of the collaboration agreement. On May 31, 2008, the Company began recognizing these deferred revenues. In addition, the Company will continue to recognize royalty revenues for the portion of the royalty earned that is due to Searle.
The Company will recognize royalty expenses in each period based on (i) deferred transaction expenses in the same manner and over the same period in which the related deferred revenues are recognized as royalty revenues plus (ii) the subroyalty paid by GlaxoSmithKline to Searle on net sales of Agenerase and Lexiva/Telzir for the period.
23
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
12. Collaborative Arrangements
Janssen Pharmaceutica, N.V.
In June 2006, the Company entered into a collaboration agreement with Janssen Pharmaceutica, N.V. ("Janssen") for the development, manufacture and commercialization of telaprevir, the Company's lead investigative HCV protease inhibitor. Under the agreement, Janssen has agreed to be responsible for 50% of the drug development costs incurred under the development program for the parties' territories (North America for the Company, and the rest of the world, other than the Far East, for Janssen) and has exclusive rights to commercialize telaprevir in its territories including Europe, South America, the Middle East, Africa and Australia. Under the development program for telaprevir, each party is incurring reimbursable drug development costs. Reimbursable costs incurred by Janssen are offset against reimbursable costs incurred by the Company. Amounts that Janssen pays to the Company for reimbursement, after the offset, are recorded as revenues. Accordingly, as Janssen incurs increased costs under the development program, the Company's revenues attributable to the reimbursement are reduced.
Janssen made a $165.0 million up-front license payment to the Company in July 2006. The up-front license payment is being amortized over the Company's estimated period of performance under the collaboration agreement. Under the agreement, Janssen agreed to make contingent milestone payments, which could total up to $380.0 million if telaprevir is successfully developed, approved and launched as a product. As of September 30, 2009, the Company had earned $100.0 million of these contingent milestone payments under the agreement. The remaining $280.0 million in milestones under the Company's agreement with Janssen include $100.0 million related to filing and approval for telaprevir from the European Medicines Evaluation Agency and $150.0 million related to the launch of telaprevir in the European Union. On September 30, 2009, the Company entered into two financial transactions related to the $250.0 million in milestones related to the filing, approval and launch of telaprevir in the European Union. Please refer to Note 13, "September 2009 Financial Transactions."
The collaboration agreement with Janssen also provides the Company with royalties on any sales of telaprevir in the Janssen territories, with a tiered royalty averaging in the mid-20% range, as a percentage of net sales in the Janssen territories, depending upon successful commercialization of telaprevir. Each of the parties will be responsible for drug supply in their respective territories. However, the agreement provides for the purchase by Janssen from the Company of materials required for Janssen's manufacture of the active pharmaceutical ingredient. In addition, Janssen will be responsible for certain third-party royalties on net sales in its territories. Janssen may terminate the agreement without cause at any time upon six months' notice to the Company.
During the three and nine months ended September 30, 2009, the Company recognized $10.2 million and $40.2 million, respectively, in revenues under the Janssen agreement, which included an amortized portion of the up-front payment and net reimbursements from Janssen for telaprevir development costs. During the three months ended September 30, 2008, the Company recognized $15.2 million in revenues under the Janssen agreement, which included an amortized portion of the up-front payment and net reimbursements from Janssen for telaprevir development costs. During the nine months ended September 30, 2008, the Company recognized $98.7 million in revenues under the Janssen agreement, which included an amortized portion of the up-front payment, a milestone of $45.0 million in connection with the commencement of a Phase 3 clinical trial of telaprevir, a milestone of $10.0 million in connection with the commencement of the Phase 2 clinical trial of telaprevir in
24
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
12. Collaborative Arrangements (Continued)
patients with genotype 2 and genotype 3 HCV infection and net reimbursements from Janssen for telaprevir development costs.
Mitsubishi Tanabe Pharma Corporation
In June 2004, the Company entered into a collaboration agreement (the "MTPC Agreement") with Mitsubishi Tanabe Pharma Corporation ("Mitsubishi Tanabe"), pursuant to which Mitsubishi Tanabe agreed to provide financial and other support for the development and commercialization of telaprevir. Under the terms of the agreement, Mitsubishi Tanabe has the right to develop and commercialize telaprevir in Japan and certain other Far East countries. The MTPC Agreement provided for payments by Mitsubishi Tanabe to the Company through Phase 2 clinical development, including an up-front license fee, development stage milestone payments and reimbursement of certain drug development costs for telaprevir.
On July 30, 2009, the Company amended the MTPC Agreement. Under the amended agreement, the Company received $105.0 million in the third quarter of 2009, and will be eligible to receive further contingent milestone payments, which if realized would range between $15.0 million and $65.0 million in the aggregate. The amended agreement provides to Mitsubishi Tanabe a fully-paid license to commercialize telaprevir to treat HCV infection in Japan and specified other countries in the Far East, as well as rights to manufacture telaprevir for sale in its territory. Mitsubishi Tanabe is responsible for its own development and manufacturing costs in its territory. Mitsubishi Tanabe may terminate the agreement at any time without cause upon 60 days' prior written notice to the Company.
Prior to the amendment, the Company recognized revenues based on an amortized portion of the up-front payment, milestones, if any, and reimbursement of certain of the Company's expenses incurred in telaprevir development. The $105.0 million payment that the Company received in the third quarter of 2009 pursuant to the amended agreement is a nonrefundable, up-front license fee and revenues related to this payment are being recognized on a straight-line basis over the Company's estimated period of performance under the agreement. The Company recognized revenues from Mitsubishi Tanabe of $6.9 million and $7.7 million, respectively, in the three and nine months ended September 30, 2009, and $2.1 million and $7.9 million, respectively, in the three and nine months ended September 30, 2008.
Merck & Co., Inc.
In June 2004, the Company entered into a global collaboration with Merck & Co., Inc. ("Merck") to develop and commercialize Aurora kinase inhibitors for the treatment of cancer. Merck is responsible for worldwide clinical development and commercialization of all compounds developed under the collaboration and will pay the Company royalties on any product sales. Merck may terminate the agreement at any time without cause upon 90 days' advance written notice, except that six months' advance written notice is required for termination at any time when a product has marketing approval in a major market and the termination is not the result of a safety issue. In the third quarter of 2008, the Company recognized a milestone payment from Merck for $6.0 million. The Company recognized $0 and $6.0 million, respectively, of revenues related to this collaboration in the nine months ended September 30, 2009 and 2008, respectively.
25
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
13. September 2009 Financial Transactions
2012 Notes
On September 30, 2009, the Company sold $155.0 million in aggregate principal amount of secured notes due 2012 (the "2012 Notes") for an aggregate of $122.2 million pursuant to a note purchase agreement with Olmsted Park S.A. (the "Purchaser"). The 2012 Notes were issued pursuant to, and the 2012 Notes are governed by the terms of, an indenture entered into on September 30, 2009 between the Company and U.S. Bank National Association, as trustee and collateral agent.
The 2012 Notes were issued at a discount and do not pay current interest prior to maturity. The 2012 Notes will mature on October 31, 2012, subject to earlier mandatory redemption to the extent milestone events set forth in the Company's collaboration with Janssen are achieved prior to October 31, 2012. $100.0 million of these potential milestone payments relate to the filing and approval of telaprevir in the European Union and $55.0 million relate to the launch of telaprevir in the European Union. The Company will be required to redeem the portion of the 2012 Notes equal to each milestone payment as each such milestone payment is earned under the Janssen collaboration.
The holders of the 2012 Notes have the right to cause the Company to repay all or any part of the 2012 Notes at 100% of the principal amount of the 2012 Notes to be repurchased if a change of control of the Company occurs. The Company may also redeem all or any part of the 2012 Notes at any time at 100% of the principal amount of the 2012 Notes to be redeemed. Upon certain events of default occurring and continuing, either the trustee or the holders of not less than 25% in aggregate principal amount of the 2012 Notes then outstanding may declare the principal of the 2012 Notes immediately due and payable. In the case of certain events of bankruptcy, insolvency or reorganization relating to the Company, the principal amount of the 2012 Notes shall automatically become and be immediately due and payable.
The Company has determined that the 2012 Notes contain an embedded derivative related to the potential mandatory redemption or early repayment of the 2012 Notes at the principal amount prior to their maturity date. The Company bifurcated the embedded derivative from the 2012 Notes because the features of the embedded derivative were not clearly and closely related to the 2012 Notes.
In connection with the issuance of the 2012 Notes, the Company granted a security interest with respect to $155.0 million of future telaprevir milestone payments that the Company is eligible to receive from Janssen for the potential future filing, approval and launch of telaprevir in the European Union.
The Company determined that the 2012 Notes had a residual value upon issuance of $108.2 million, which excludes the $10.7 million value of the embedded derivative. In future periods, the Company expects that it will record a quarterly interest expense determined using the effective interest rate method, which will increase the amount of the liability for the 2012 Notes each quarter by an amount corresponding to this interest expense through the stated maturity date, unless redeemed or repaid earlier. The Company determined that the fair value of the embedded derivative as of September 30, 2009 was $10.7 million based on a probability-weighted model of the discounted value that a market participant would ascribe to the potential mandatory redemption and early repayment features of the 2012 Notes. The fair value of this embedded derivative will be evaluated quarterly, with any changes in the fair value of the embedded derivative resulting in a corresponding loss or gain. The liabilities related to the 2012 Notes, including the embedded derivative, are reflected together on the Company's condensed consolidated balance sheet as a long-term liability.
26
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
13. September 2009 Financial Transactions (Continued)
Sale of Potential Milestone Payments
On September 30, 2009, the Company entered into two purchase agreements with the Purchaser pursuant to which the Company sold its rights to an aggregate of $95.0 million in potential future milestone payments pursuant to the Janssen collaboration related to the launch of telaprevir in the European Union for non-refundable payments totaling $32.8 million. The $32.8 million cash payment was received on October 1, 2009. The purchase agreements contain representations, warranties, covenants and indemnification obligations of each party, including the obligation of the Company to make the milestone payments to the Purchaser when the underlying milestone events are achieved if the Janssen collaboration had been terminated.
The Company determined that this sale of a potential future revenue stream should be accounted for as a liability related to the sale of the future milestone payments because the Company has significant continuing involvement in the generation of the potential revenues pursuant to its collaboration agreement with Janssen. As a result, the Company recorded a liability on its condensed consolidated balance sheet equal to the fair value of the purchase agreements. No revenues or deferred revenues have been recorded on account of the $32.8 million that the Company received from the Purchaser pursuant to these purchase agreements. In addition, the Company determined that the purchase agreements are free-standing derivative instruments. The Company determined that the initial aggregate fair value of the free-standing derivative created by the sale of the rights to future milestone payments to the Purchaser pursuant to the purchase agreements was $36.2 million based on a probability-weighted model of the discounted value that a market participant would ascribe to these rights. The models used to estimate the fair value of the rights sold to the Purchaser pursuant to the purchase agreements require the Company to make estimates regarding, among other things, the assumptions a market participant would make regarding the timing and probability of achieving the milestones and the appropriate discount rates. The fair value of the rights sold to the Purchaser pursuant to the purchase agreements will be evaluated each reporting period, with any changes in the fair value of the derivative instruments based on the probability of achieving the milestones, the timing of achieving the milestones or discount rates resulting in a corresponding gain or loss. Because the Company's estimate of the fair value of the rights to the future milestone payments includes the application of a discount rate to reflect the time-value of money, the Company expects to record interest costs related to this liability balance each quarter.
14. Management Transition
Matthew W. Emmens, one of the Company's directors, became the Company's Chairman and Chief Executive Officer in May 2009. On February 5, 2009, the Company entered into a transition arrangement with Dr. Joshua S. Boger. The benefits to Dr. Boger under the transition arrangement include: (i) a lump sum payment of $2.9 million payable in November 2009, (ii) 18 months' accelerated vesting of his outstanding stock options, which will remain exercisable until December 31, 2010, subject to specified limitations, (iii) 18 months' accelerated vesting of each outstanding restricted stock award, treating each award as if it vests ratably over the term of the grant rather than the end of the service period and (iv) reimbursement for certain expenses. The Company recorded expenses of $0 and $2.9 million, respectively, in the three and nine months ended September 30, 2009 in connection with the lump sum payable in November 2009. In the three and nine months ended September 30, 2009, the
27
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
14. Management Transition (Continued)
Company recorded non-cash charges of $0 and $10.5 million, respectively, due to the acceleration and extended exercisability of Dr. Boger's equity awards under the transition arrangement.
15. Guarantees
As permitted under Massachusetts law, the Company's Articles of Organization and Bylaws provide that the Company will indemnify certain of its officers and directors for certain claims asserted against them in connection with their service as an officer or director. The maximum potential amount of future payments that the Company could be required to make under these indemnification provisions is unlimited. However, the Company has purchased directors' and officers' liability insurance policies that could reduce its monetary exposure and enable it to recover a portion of any future amounts paid. No indemnification claims are currently outstanding and the Company believes the estimated fair value of these indemnification arrangements is minimal.
The Company customarily agrees in the ordinary course of its business to indemnification provisions in agreements with clinical trial investigators and sites in its drug development programs, in sponsored research agreements with academic and not-for-profit institutions, in various comparable agreements involving parties performing services for the Company in the ordinary course of business, and in its real estate leases. The Company also customarily agrees to certain indemnification provisions in its drug discovery, development and commercialization collaboration agreements. With respect to the Company's clinical trials and sponsored research agreements, these indemnification provisions typically apply to any claim asserted against the investigator or the investigator's institution relating to personal injury or property damage, violations of law or certain breaches of the Company's contractual obligations arising out of the research or clinical testing of the Company's compounds or drug candidates. With respect to lease agreements, the indemnification provisions typically apply to claims asserted against the landlord relating to personal injury or property damage caused by the Company, to violations of law by the Company or to certain breaches of the Company's contractual obligations. The indemnification provisions appearing in the Company's collaboration agreements are similar, but in addition provide some limited indemnification for its collaborator in the event of third-party claims alleging infringement of intellectual property rights. In each of the cases above, the indemnification obligation generally survives the termination of the agreement for some extended period, although the obligation typically has the most relevance during the contract term and for a short period of time thereafter. The maximum potential amount of future payments that the Company could be required to make under these provisions is generally unlimited. The Company has purchased insurance policies covering personal injury, property damage and general liability that reduce its exposure for indemnification and would enable it in many cases to recover a portion of any future amounts paid. The Company has never paid any material amounts to defend lawsuits or settle claims related to these indemnification provisions. Accordingly, the Company believes the estimated fair value of these indemnification arrangements is minimal.
On February 12, 2008, the Company entered into underwriting agreements with Merrill Lynch, Pierce, Fenner & Smith Incorporated, on September 18, 2008, the Company entered into an underwriting agreement with Goldman, Sachs & Co. and on February 18, 2009, the Company entered into an underwriting agreement with Merrill Lynch, Pierce, Fenner & Smith Incorporated (collectively, the "Underwriting Agreements"), as the representative of the several underwriters, if any, named in such agreements, relating to the public offering and sale of shares of the Company's common stock or
28
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements (Continued)
(unaudited)
15. Guarantees (Continued)
convertible senior subordinated notes. The Underwriting Agreement relating to each offering requires the Company to indemnify the underwriters against any loss they may suffer by reason of the Company's breach of representations and warranties relating to that public offering, the Company's failure to perform certain covenants in those agreements, the inclusion of any untrue statement of material fact in the prospectus used in connection with that offering, the omission of any material fact needed to make those materials not misleading, and any actions taken by the Company or its representatives in connection with the offering. The representations, warranties and covenants in the Underwriting Agreements are of a type customary in agreements of this sort. The Company believes the estimated fair value of these indemnification arrangements is minimal.
16. Contingencies
The Company has certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a reserve for contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There were no contingent liabilities accrued as of September 30, 2009 or December 31, 2008.
17. Recent Accounting Pronouncements
In September 2009, the Financial Accounting Standards Board ("FASB") provided updated guidance (1) on whether multiple deliverables exist, how the deliverables in a revenue arrangement should be separated, and the consideration allocated; (2) requiring an entity to allocate revenue in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (3) eliminating the use of the residual method and requiring an entity to allocate revenue using the relative selling price method. The update is effective for fiscal years beginning on or after June 15, 2010, with early adoption permitted. Adoption may either be on a prospective basis or by retrospective application. The Company is currently evaluating the effect of this update to its accounting and reporting systems and processes; however, at this time the Company is unable to quantify the impact on its condensed consolidated financial statements of its adoption or determine the timing and method of its adoption.
In June 2009, the FASB issued an update to the accounting and disclosure requirements for the consolidation of variable interest entities ("VIE"s). This update requires a qualitative approach to identifying a controlling financial interest in a VIE, and requires ongoing assessment of whether an entity is a VIE and whether an interest in a VIE makes the holder the primary beneficiary of the VIE. This update will be effective for the Company on January 1, 2010. The Company is evaluating the effect of the pending adoption of this update on the Company's condensed consolidated financial statements.
In June 2009, the FASB issued an update to the accounting and disclosure requirements for transfers of financial assets. This update is intended to improve the relevance, representational faithfulness, and comparability of the information that a reporting entity provides in its financial reports about a transfer of financial assets; the effects of a transfer on its financial position, financial performance, and cash flows; and a transferor's continuing involvement in transferred financial assets. The recognition and measurement provisions of this update shall be applied to transfers that occur on or after January 1, 2010, which is the date upon which this accounting update becomes effective for the Company. The Company is evaluating the effect of the pending adoption of this update on the Company's condensed consolidated financial statements.
29
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Overview
We are in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, our lead drug candidate, is an oral hepatitis C protease inhibitor and one of the most advanced of a new class of antiviral treatments in clinical development that targets hepatitis C virus, or HCV, infection. Telaprevir is being evaluated in a fully-enrolled registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV. We currently intend to submit a new drug application, or NDA, for telaprevir in the United States in the second half of 2010, assuming the successful completion of the registration program. We also are developing, among other compounds, VX-770 and VX-809, drug candidates for the treatment of patients with cystic fibrosis, or CF, and VX-509, a Janus kinase 3, or JAK3, inhibitor designed for the treatment of immune-mediated inflammatory diseases including rheumatoid arthritis. In the second quarter of 2009, we began a registration program for VX-770 that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. We intend to continue investing in our research programs with the goal of adding to our pipeline drug candidates designed to address significant unmet medical needs and provide substantial benefits to patients.
Business Focus
Over the upcoming years, we expect to focus a substantial portion of our resources on the development and commercialization of telaprevir. Our clinical development program is designed to support registration by us of telaprevir in North America for treatment-naïve and treatment-failure patients with genotype 1 HCV, and by our collaborators, Janssen Pharmaceutica, N.V., a Johnson & Johnson company, and Mitsubishi Tanabe Pharma Corporation, in international markets.
In the second quarter of 2009, we initiated a registration program for VX-770 focused on patients with CF who have the G551D mutation. We also expect to continue the development of VX-809, an investigational corrector compound that is being evaluated in a Phase 2a clinical trial in patients with CF. As a result, we expect that over the next several years we will need to substantially increase resources focused on the development of our CF drug candidates. We plan to leverage the infrastructure that we are building in preparation for the potential launch of telaprevir to support the potential launch of VX-770.
In addition to the registration programs for telaprevir and VX-770, we plan to continue investing in our research and development programs and to develop selected drug candidates that emerge from those programs, alone or with third-party collaborators. We believe that meaningful information will be provided by ongoing and planned Phase 2 clinical trials for a number of our earlier-stage drug candidates, including a planned combination clinical trial in patients with HCV of telaprevir with VX-222, our recently acquired HCV polymerase inhibitor, ongoing and planned Phase 2 clinical trials of VX-809 in patients with the most common CF mutation, and a planned Phase 2a clinical trial of VX-509 in patients with moderate to severe rheumatoid arthritis, allowing us to make decisions regarding future development activities in these programs.
Drug Discovery and Clinical Development
Discovery and development of a new pharmaceutical product is a lengthy and resource-intensive process, which may take 10 to 15 years or more. Throughout this entire process, potential drug candidates are subjected to rigorous evaluation, driven in part by stringent regulatory considerations, designed to generate information concerning efficacy, side-effects, proper dosage levels and a variety of other physical and chemical characteristics that are important in determining whether a drug candidate should be approved for marketing as a pharmaceutical product. The toxicity characteristics and profile of drug candidates at varying dose levels administered for varying periods of time also are monitored
30
and evaluated during the nonclinical and clinical development process. Most chemical compounds that are investigated as potential drug candidates never progress into formal development, and most drug candidates that do advance into formal development never become commercial products. A drug candidate's failure to progress or advance may be the result of any one or more of a wide range of adverse experimental outcomes including, for example, the lack of sufficient efficacy against the disease target, the lack of acceptable absorption characteristics or other physical properties, difficulties in developing a cost-effective manufacturing or formulation method, or the discovery of toxicities or side-effects that are unacceptable for the disease indication being treated or that adversely affect the competitive commercial profile of the drug candidate.
Designing, coordinating and conducting large-scale clinical trials to determine the efficacy and safety of drug candidates and to support the submission of an NDA requires significant financial resources, along with extensive technical and regulatory expertise and infrastructure. Prior to commencing a late-stage clinical trial of any drug candidate, we must work collaboratively with regulatory authorities, including the United States Food and Drug Administration, or FDA, in order to identify the specific scientific issues that need to be addressed by the clinical trials in order to support continued development and approval of the drug candidate. These discussions with regulatory authorities typically occur over a period of months and can result in significant changes to planned clinical trial designs or timelines. In addition, even after agreement with respect to a clinical trial design has been reached, regulatory authorities may request additional clinical trials or changes to existing clinical trial protocols. If the data from our ongoing clinical trials or nonclinical studies regarding the safety or efficacy of our drug candidates are not favorable, we may be forced to delay or terminate the clinical development program, which, particularly in the case of telaprevir, would materially harm our business. Further, even if we obtain marketing approvals from the FDA and comparable foreign regulatory authorities in a timely manner, we cannot be sure that the drug will be commercially successful.
Our investments are subject to the considerable risk that one or more of our drug candidates will not progress to product registration due to a wide range of adverse experimental outcomes. We monitor the results of our clinical trials, discovery research and our nonclinical studies and frequently evaluate our portfolio investments in light of new data and scientific, business and commercial insights with the objective of balancing risk and potential. This process can result in relatively abrupt changes in focus and priority as new information becomes available and is analyzed and we gain additional insights into ongoing programs and potential new programs. Although we believe that our development activities and the clinical trial data we have obtained to date have reduced the risks associated with obtaining marketing approval for telaprevir, we cannot be sure that our development of telaprevir will lead successfully to regulatory approval of telaprevir on a timely basis, or at all, or that obtaining regulatory approval will lead to commercial success of telaprevir. With respect to our other drug candidates, we have more limited data from clinical trials and nonclinical studies and as a result it is difficult to predict which, if any, of these drug candidates will result in pharmaceutical products.
Drug Candidates
HCV
Telaprevir
Telaprevir, our oral HCV protease inhibitor, is being investigated in a registration program focused on patients with genotype 1 HCV that includes ADVANCE and ILLUMINATE, which are Phase 3 clinical trials in treatment-naïve patients, and REALIZE, which is a Phase 3 clinical trial in treatment-failure patients. Enrollment in ADVANCE, ILLUMINATE and REALIZE was completed in October 2008, January 2009 and February 2009, respectively. Telaprevir dosing is complete in all three of these Phase 3 clinical trials. We expect to have sustained viral response, or SVR, data from the ADVANCE
31
and ILLUMINATE clinical trials in the first half of 2010 and SVR data from the REALIZE clinical trial in mid-2010. We currently intend to submit an NDA for telaprevir in the second half of 2010, assuming the successful completion of our ongoing registration program. In addition to the clinical trials in our registration program, several additional clinical trials are being conducted by us and our collaborators.
The successful development and commercialization of telaprevir is critical to the success of our business as currently conducted. While we are devoting significant resources, time and attention to the development, potential regulatory approval and a successful commercial launch of telaprevir, all of these efforts involve significant scientific and execution risks and can be adversely affected by events, such as competitive activities, adverse trial results and regulatory actions, outside of our direct control.
PROVE Phase 2b Clinical Trials
We have completed three Phase 2b clinical trials of telaprevir-based combination therapy in patients with genotype 1 HCV, which enrolled an aggregate of approximately 580 treatment-naïve patients and 440 patients who did not achieve an SVR with a previous treatment with pegylated-interferon, or peg-IFN, and ribavirin, or RBV. The SVR rates on an intent-to-treat basis of the patients in the 24-week telaprevir-based treatment arms and the control arms of PROVE 1 and PROVE 2, the two Phase 2b clinical trials that evaluated treatment-naïve patients, are set forth in the table below:
|
PROVE 1 | PROVE 2 | ||||||
---|---|---|---|---|---|---|---|---|
24-week telaprevir-based treatment arm: |
||||||||
telaprevir in combination with peg-IFN and RBV for 12 weeks, followed by peg-IFN and RBV alone for 12 weeks |
61 | % | 69 | % | ||||
48-week control arm: |
||||||||
48 weeks of therapy with peg-IFN and RBV |
41 | % | 46 | % |
The SVR rates of the patients on an intent-to-treat basis in the 24-week telaprevir-based triple-therapy treatment arm, the 48-week telaprevir-based treatment arm and the control arm of PROVE 3, the Phase 2b clinical trial that evaluated treatment-failure patients, are set forth in the table below:
|
Non-responders | Relapsers | Breakthroughs | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
24-week telaprevir-based triple-therapy treatment arm: | ||||||||||||||
telaprevir in combination with peg-IFN and RBV for 12 weeks, followed by peg-IFN and RBV alone for 12 weeks | 39% (n=66) | 69% (n=42) | 57% (n=7) | 51% (n=115) | ||||||||||
48-week telaprevir-based treatment arm: | ||||||||||||||
telaprevir in combination with peg-IFN and RBV for 24 weeks, followed by peg-IFN and RBV alone for 24 weeks | 38% (n=64) | 76% (n=41) | 50% (n=8) | 52% (n=113) | ||||||||||
48-week control arm: | ||||||||||||||
48 weeks of therapy with peg-IFN and RBV | 9% (n=68) | 20% (n=41) | 40% (n=5) | 14% (n=114) |
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The adverse event profile of telaprevir generally has been consistent across our Phase 2 clinical trials, which have principally involved clinical trial sites in North America and Europe. Safety data from our Phase 2 clinical trials indicated that the most common adverse events, regardless of treatment assignment, were fatigue, rash, headache and nausea. The most common adverse events reported more frequently in patients receiving telaprevir than in the control arms were gastrointestinal events, skin eventsrash and pruritusand anemia. There have been reports of severe rashes in clinical trials involving telaprevir-based treatments, including several reports from the clinical trials being conducted by Mitsubishi Tanabe in Japan, where telaprevir has advanced into Phase 3 clinical trials in combination with peg-IFN and RBV. Rash resulted in treatment discontinuations in the telaprevir-based treatment arms in approximately 7% of patients in PROVE 1 and PROVE 2 and 5% of patients in PROVE 3. Other adverse events reported in our Phase 2 clinical trials generally were similar in type and frequency to those seen with peg-IFN and RBV treatment.
Additional Phase 2 Clinical Trials of Telaprevir
In October 2009, we announced data from the C208 trial, which was an exploratory open-label clinical trial that enrolled 161 treatment-naïve patients infected with genotype 1 HCV. The purpose of the C208 trial was to compare twice-daily dosing regimens of telaprevir1,125 mg every 12 hoursin combination with peg-IFN and RBV, with three-times daily dosing regimens750 mg every 8 hoursin combination with peg-IFN and RBV. A three-times daily dosing regimen is being used in the ongoing registration program for telaprevir and has also been used in the other clinical trials for telaprevir.
Patients received telaprevir, peg-IFN and RBV for 12 weeks followed by an additional 12 or 36 weeks of peg-IFN and RBV alone in a response-guided trial design. Patients who achieved undetectable HCV RNA<25 IU/mL, undetectable per Roche COBAS TaqMan HCV testat week 4, which is referred to as a rapid viral response, or RVR, and who maintained undetectable HCV RNA through week 20, were able to stop all treatment after 24 weeks. Patients who did not meet the response-guided criteria received a total of 48 weeks of peg-IFN and RBV therapy. 18% of patients across the treatment arms were required to continue treatment for 48 weeks.
The following table summarizes the RVR and SVR data on an intent-to-treat basis from the C208 trial.
Telaprevir Dosing
|
Combination Therapy | Total Number of Patients |
RVR (undetectable at week 4 on treatment) |
SVR (undetectable 24 weeks after end-of- treatment) |
||||
---|---|---|---|---|---|---|---|---|
1,125 mg every 12 hours |
alfa-2a (PEGASYS)/RBV | 40 | 83% (n=33) | 83% (n=33) | ||||
1,125 mg every 12 hours |
alfa-2b (PEGINTRON)/RBV | 39 | 67% (n=26) | 82% (n=32) | ||||
750 mg every 8 hours |
alfa-2a (PEGASYS)/RBV | 40 | 80% (n=32) | 85% (n=34) | ||||
750 mg every 8 hours |
alfa-2b (PEGINTRON)/RBV | 42 | 69% (n=29) | 81% (n=34) |
The frequency and severity of adverse events and the rate of treatment discontinuations were similar to those reported in prior telaprevir trials. The most common adverse events reported in patients in this clinical trial were pruritis, nausea, rash, anemia, flu-like illness, fatigue and headache, and the adverse events were similar overall between the patient groups receiving three-times daily dosing and those receiving twice-daily dosing. Serious adverse events leading to permanent treatment discontinuation of all drugs occurred in 5% of patients and were mainly related to rash, which resulted in discontinuation of 4 out of 161, or 3%, of patients and anemia, which resulted in discontinuation of 3 out of 161, or 2%, of patients.
In October 2009, we also announced interim data from a clinical trial, referred to as the 107 Trial, in patients who did not achieve an SVR in the control arms of the PROVE 1, PROVE 2 or PROVE 3 clinical trials. In the open-label 107 Trial, treatment-experienced patients with genotype 1 HCV were
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treated with telaprevir triple combination therapy for 12 weeks followed by 12 or 36 weeks of treatment with peg-IFN and RBV alone. In 2008, the protocol for the 107 Trial underwent several amendments, including important amendments that affected prior null-responders.
The table below sets forth the interim data from 94 of the 117 patients enrolled in the 107 Trial, including SVR data and data regarding patients who relapsed in the 24 weeks after end-of-treatment.
Patient Group
|
Treatment Regimen | SVR | Viral Relapse Rates | |||
---|---|---|---|---|---|---|
Prior Null Responders |
telaprevir triple combination for 12 weeks, followed by peg-IFN and RBV alone for 36 weeks |
57% (16/28) | 20% (4/20) | |||
Prior Partial Responders |
25 patients treated with telaprevir triple combination therapy for 12 weeks, followed by peg-IFN and RBV alone for 12 weeks |
55% (16/29) |
22% (5/23) |
|||
|
3 patients treated with telaprevir triple combination therapy combination for 12 weeks, followed by peg-IFN and RBV alone for 36 weeks |
|||||
|
1 patient who discontinued prior to completing 12 weeks of telaprevir triple combination therapy |
|||||
Prior Relapsers |
25 patients treated with telaprevir triple combination therapy for 12 weeks, followed by peg-IFN and RBV alone for 12 weeks |
90% (26/29) |
4% (1/28) |
|||
|
3 patients treated with telaprevir triple combination therapy for 12 weeks, followed by peg-IFN and RBV alone for 36 weeks |
|||||
|
1 patient who discontinued prior to completing 12 weeks of telaprevir triple combination therapy |
|||||
Prior Viral Breakthroughs |
7 patients treated with telaprevir triple combination therapy for 12 weeks, followed by peg-IFN and RBV alone for 12 weeks |
75% (6/8) |
0% (0/6) |
|||
|
1 patient treated with telaprevir triple combination therapy for 12 weeks, followed by peg-IFN and RBV alone for 36 weeks |
The interim results reported in the table above reflect data from all prior partial responders, relapsers and viral breakthroughs and from the prior null responders who we considered to have received an appropriate treatment regimen based on their prior response to peg-IFN and RBV, consistent with certain amendments made during the conduct of the 107 Trial. The table does not include data from 23 prior null responders, who, prior to protocol amendments, were designated to receive only 24 weeks of therapy, and a portion of whom met the strict stopping rule criteria at week 4 that were in effect at that time. When the 107 Trial began, all patients were to receive 12 weeks of telaprevir in combination with peg-IFN and RBV followed by an additional 12 weeks of peg-IFN and RBV. Stopping rules required any patient who did not achieve undetectable HCV RNA by week 4 to stop all treatment. In 2008, the 107 Trial protocol was amended in several respects. The most important change to the protocol was to the week 4 stopping rules, as it became evident that treatment-failure patients had a somewhat slower viral response to treatment with telaprevir triple-combination therapy than did treatment-naïve patients. Therefore, following the protocol amendment patients who had detectable HCV RNA at week 4 were permitted to continue therapy. In addition, while the initial study protocol specified 24 weeks of total treatment for all patients, a longer total treatment duration of 48 weeks was determined to be warranted in prior null responders to provide a higher likelihood of achieving an SVR.
Discontinuation of all therapy due to adverse events occurred in eight patients in the 107 Trial. A complete safety analysis is still being performed and will be reported when the full data are presented at a medical conference expected in 2010.
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HCV Polymerase Inhibitors
HCV polymerase inhibitors, including our HCV polymerase inhibitors VX-222 (formerly VCH-222) and VX-759 (formerly VCH-759), are direct-acting antivirals that inhibit the ability of the HCV to replicate through a mechanism distinct from HCV protease inhibitors such as telaprevir. VX-222 and VX-759 were evaluated by ViroChem Pharma, Inc., or ViroChem, in Phase 1 clinical trials prior to our acquisition of ViroChem in March 2009. In a Phase 1 viral kinetics clinical trial involving five treatment-naïve patients with genotype 1 HCV infection, VX-222 dosed at 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNAequivalent to a 5,000-fold reduction in virus in the bloodat the end of three days of dosing. The results were consistent from patient to patient, and across HCV genotype 1 subtypes. In clinical evaluations of VX-222 to date, no serious adverse events have been observed.
We are conducting a multi-dose viral kinetics clinical trial to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of VX-222 in patients with genotype 1 HCV infection. This ongoing multi-dose clinical trial of VX-222 will evaluate the antiviral activity of VX-222 dosed as monotherapy for three days in approximately 32 treatment-naïve patients with HCV genotype 1 infection. We also are conducting a drug-drug interaction clinical trial of VX-222 and telaprevir in healthy volunteers. We expect data from these clinical trials in the fourth quarter of 2009, which could enable the initiation of a combination trial of telaprevir and VX-222 in patients with genotype 1 HCV as early as the fourth quarter of 2009, depending on the trial results. There currently are no ongoing clinical trials of VX-759.
Cystic Fibrosis
VX-770
In May 2009, we initiated a registration program, referred to as ENDEAVOR, for VX-770, which is an investigational cystic fibrosis transmembrane conductance regulator, or CFTR, potentiator that targets the defective CFTR protein that causes CF. The VX-770 registration program focuses on patients with the G551D mutation, which is present in approximately 4% of the CF population in the United States. ENDEAVOR consists of three clinical trials, which have opened for enrollment.
The primary clinical trial, which is referred to as STRIVE, is a Phase 3 clinical trial of VX-770 in patients 12 years and older with the G551D mutation on at least one of the patient's two CFTR genes, or alleles. We expect STRIVE to be fully enrolled in the first quarter of 2010. The second clinical trial, which is referred to as ENVISION, is a two-part Phase 3 clinical trial of VX-770 in patients between 6 to 11 years of age with the G551D mutation on at least one allele. The third clinical trial, which is referred to as DISCOVER, is a Phase 2 exploratory clinical trial of VX-770 in patients with CF who are 12 years and older and homozygous for the F508del mutation. The DISCOVER clinical trial opened to patient enrollment in the third quarter of 2009.
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In October 2008, we completed a Phase 2a clinical trial of VX-770 in 39 patients with CF with the G551D mutation. Patients in the Phase 2a clinical trial received VX-770 over 14-day and 28-day dosing periods. The primary endpoint for this clinical trial was safety, and no serious adverse events attributable to VX-770 were observed. The promising lung function data from this Phase 2a clinical trial, as measured by improvements in FEV1, and the observed changes in biomarkers that seek to measure the activity of the CFTR protein, were used to design the ENDEAVOR registration program.
VX-809
We have conducted Phase 1 clinical trials of VX-809, a CFTR corrector compound, in healthy volunteers and an escalating single-dose pharmacokinetics and safety clinical trial of VX-809 in patients with CF who carry the F508del mutation on the CFTR gene, the most common mutation in CF patients, on at least one allele. In the first quarter of 2009, we initiated a Phase 2a clinical trial primarily designed to evaluate the safety and tolerability of multiple doses of VX-809 in approximately 90 patients with CF homozygous for the F508del mutation in the CFTR gene. In addition to assessing safety, this Phase 2a trial will evaluate the effect of VX-809 on biomarkers of CFTR function and whether VX-809 has an effect on FEV1. Enrollment in the trial is complete, and we expect to obtain data from this clinical trial in early 2010.
We have initiated a drug-drug interaction clinical trial of VX-809 and VX-770. Based on in vitro data, we believe that there is a rationale to explore the clinical potential for combining VX-809 and VX-770 and may seek to commence a combination clinical trial in patients with CF in the second half of 2010.
Immune-mediated Inflammatory Disease
VX-509 is a novel oral JAK3 inhibitor that we believe has the potential to be used in multiple immune-mediated inflammatory disease, or IMID, indications. We have completed the Phase 1 clinical trials of VX-509, including a Phase 1 single and multiple, 14-day, dose-ranging clinical trial of VX-509 in healthy volunteers. We expect to initiate a Phase 2a clinical trial of VX-509 in patients with moderate to severe rheumatoid arthritis in the first quarter of 2010. This double-blind, randomized, placebo-controlled 12-week trial is expected to enroll approximately 200 patients, and we expect that initial clinical data from this trial, including measurements of safety, tolerability and clinical activity, will be available in the second half of 2010. We plan to continue to pursue collaborative opportunities for VX-509 with major pharmaceutical companies, but expect that no collaboration would be entered into until after the receipt of clinical data from the Phase 2a trial.
Corporate Collaborations
Corporate collaborations have been and will continue to be an important component of our business strategy. Under our agreement with Janssen, we have retained exclusive commercial rights to telaprevir in North America, and we are leading the global clinical development program. Janssen agreed to be responsible for 50% of the drug development costs under the development program for telaprevir in North America and the Janssen territories, to pay us contingent milestone payments based on successful development, approval and launch of telaprevir, to be responsible for the commercialization of telaprevir outside of North America and the Far East and to pay us royalties on any sales of telaprevir in its territories. The principal remaining milestones under our agreement with Janssen relate to marketing authorization for telaprevir from the European Medicines Evaluation Agency and the launch of telaprevir in the European Union. These milestones include $100.0 million related to regulatory submission and approval and $150.0 million related to launch of telaprevir. As a result of financial transactions discussed below that we entered into on September 30, 2009, the first $155.0 million of these milestone payments will trigger obligations to redeem a corresponding portion of a $155.0 million promissory note that we issued at a discount in September 2009, and the rights to
36
receive the remaining $95.0 million of these milestone payments have been sold to a third party. Our collaboration with Janssen was unchanged by these transactions, and we continue to be eligible to receive a royalty on future product sales in Janssen's commercial territories, including the European Union.
We also have a collaboration with Mitsubishi Tanabe with respect to the development of telaprevir in Japan and specified other countries in the Far East. Mitsubishi Tanabe is conducting Phase 3 registration trials in Japan of telaprevir in combination with peg-IFN and RBV in approximately 300 patients with genotype 1 HCV. This registration program is fully enrolled. On July 30, 2009, we amended our license, development and commercialization agreement with Mitsubishi Tanabe. Under the amended agreement, we received $105.0 million in the third quarter of 2009, and will be eligible to receive further contingent milestone payments, which if realized would range between $15.0 million and $65.0 million in the aggregate. The amended agreement provides to Mitsubishi Tanabe a fully-paid license to commercialize telaprevir to treat HCV infection in Japan and specified other countries in the Far East, as well as rights to manufacture telaprevir for sale in its territory.
Our drug candidate pipeline also includes Aurora kinase inhibitors that are being investigated by Merck & Co., Inc. for oncology indications. In the second quarter of 2008, Merck initiated a Phase 1 clinical trial of MK-5108 (VX-689) alone and in combination with docetaxel in patients with advanced and/or refractory tumors. In the third quarter of 2008, Merck selected additional Aurora kinase inhibitors for potential development.
We will not have the resources for some time to develop and commercialize all drug candidates for which we have rights, and therefore we will need to rely on corporate collaborations for the development and commercialization of some or all of our new drug candidates. Historically, we have been successful in initiating and concluding productive collaborations, but we will need to continue to do so in the future, even though economic and competitive conditions may be different than in the past.
Financial Transactions Related to Potential Future Telaprevir Milestone Payments
On September 30, 2009, we entered into two financial transactions related to potential future milestone payments pursuant to our collaboration with Janssen that resulted in aggregate payments to us of $155.0 million. Of the aggregate payments, we received $122.2 million on September 30, 2009 and $32.8 million on October 1, 2009. In the first transaction, we received $122.2 million in cash for the issuance of secured notes due October 2012, referred to as the 2012 Notes. The 2012 Notes have a face value of $155.0 million, were issued at a discount and do not carry an explicit interest rate. The 2012 Notes mature on October 31, 2012, subject to earlier mandatory redemption as specified milestone events under our Janssen collaboration relating to the filing, approval and launch of telaprevir in the European Union are achieved, if at all, prior to October 31, 2012. The 2012 Notes are secured by $155.0 million in potential telaprevir milestone payments we are eligible to receive from Janssen upon specified milestone events. In the second transaction, we received non-refundable payments totalling $32.8 million in cash for the sale of rights to $95.0 million of potential future milestone payments that we are eligible to receive from Janssen for the launch of telaprevir in the Europe Union.
Financing Strategy
We have incurred losses from our inception and expect to continue to incur losses at least until we obtain approval for and successfully commercialize a product, if we ever do. Therefore, we are dependent in large part on our continued ability to raise significant funding to finance our research and development operations, to create a commercial infrastructure, and to meet our overhead costs and long-term contractual commitments and obligations. To date, we have secured funds principally through
37
capital market transactions, strategic collaborative agreements, proceeds from the disposition of assets, investment income and the issuance of common stock under our employee benefit plans.
We expect that we will need additional capital in order to complete the development and commercialization of telaprevir while at the same time continuing the development of our other drug candidates. We may raise additional capital from public offerings or private placements of our securities or other methods of financing. We cannot be sure that any such financing opportunities will be available on acceptable terms, if at all. If adequate funds are not available on acceptable terms, or at all, we may be required to curtail significantly or discontinue one or more of our research, drug discovery or development programs, including clinical trials, incur significant cash exit costs, or attempt to obtain funds through arrangements with collaborators or others that may require that we relinquish rights to certain of our technologies or drug candidates.
As part of our strategy for managing our capital structure, we have from time to time adjusted the amount and maturity of our debt obligations through new issues, privately negotiated transactions and market purchases, depending on market conditions and our perceived needs at the time. For example, in the second quarter of 2009, we exchanged 6.6 million shares of newly-issued common stock for $143.5 million in aggregate principal amount of our 4.75% convertible senior subordinated notes due 2013, or 2013 Notes, plus accrued interest. We expect to continue pursuing a general financial strategy that may lead us to undertake one or more additional transactions with respect to our outstanding debt obligations, and the amounts involved in any such transactions, individually or in the aggregate, may be material. Any such transactions may or may not be similar to transactions in which we have engaged in the past.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reported periods. These items are monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are reflected in reported results for the period in which they become known. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate. There were no material changes during the nine months ended September 30, 2009 to our critical accounting policies as reported in our Annual Report on Form 10-K for the year ended December 31, 2008. We have added a critical accounting policy regarding business combinations as a result of our acquisition of ViroChem in March 2009 and a critical accounting policy regarding the accounting for the September 2009 financial transactions, and have supplemented our critical accounting policy regarding up-front license fees.
Business Combinations
In March 2009, we acquired ViroChem for $100.0 million in cash and common stock with a fair market value of $290.6 million. We assign the value of the consideration transferred to acquire a business to the tangible assets and identifiable intangible assets acquired and liabilities assumed, on the basis of their fair values at the date of acquisition. For purposes of the condensed consolidated balance sheet, we allocated the purchase price for ViroChem to net tangible assets and intangible assets. The difference between the purchase price and the fair value of assets acquired and liabilities assumed was allocated to goodwill. This goodwill relates to the potential synergies from the possible development of
38
combination therapies involving telaprevir and the acquired drug candidates. The allocations recorded on our condensed consolidated balance sheet included $525.9 million of intangible assets related to in-process research and development and a $162.5 million deferred tax liability.
The intangible assets are in-process research and development assets relating to the drug candidates being developed by ViroChem, primarily VX-222 and VX-759, each of which was in Phase 1 clinical development at the date of acquisition. VX-222 and VX-759 had estimated fair values of $412.9 million and $105.8 million, respectively. In addition, we considered ViroChem's other clinical drug candidates and determined that VCH-286, ViroChem's lead HIV drug candidate, had an estimated fair value of $7.2 million, based on development costs through the acquisition date, and that the other clinical drug candidates had no fair value because the clinical and non-clinical data for those drug candidates did not support further development as of the acquisition date. We also considered ViroChem's preclinical programs and other technologies and determined that because of uncertainties related to the safety, efficacy and commercial viability of the potential drug candidates, market participants would not ascribe value to those assets.
We assess the fair value of assets, including intangible assets such as in-process research and development, using a variety of methods, including present-value models that are based upon multiple probability-weighted scenarios involving the development and potential commercialization of the acquired drug candidates. The present-value models used to estimate the fair values of VX-222 and VX-759 reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset, including the probability of completing in-process research and development projects, which requires successfully completing clinical trials and obtaining regulatory approval for marketing of the associated drug candidate; estimates regarding the timing of and the expected costs to complete in-process research and development projects; estimates of future cash flows from potential product sales; and appropriate discount rates. The estimated fair value ascribed to VX-222 and VX-759 was based on the estimated fair value that would be ascribed to each of these compounds by a market participant that acquired both compounds in a single transaction. The assumed probability of advancing VX-222 and VX-759 through various phases of development reflects the understanding among market participants that most drug candidates that enter Phase 2 clinical trials are not ultimately approved for commercial sale. While, on the date of acquisition, each of the HCV polymerase inhibitors was at a similar stage of development, we attributed a significantly higher value to VX-222 than to VX-759 because the clinical and non-clinical data from the VX-222 research program was significantly more promising than the clinical and non-clinical data from the VX-759 research program. In addition, the fair value estimate incorporates our determination that a market participant would not be likely to continue development of VX-759 unless future data from clinical trials or non-clinical studies of VX-222 resulted in a delay or discontinuation of the VX-222 development program. Finally, while the duration and cost of non-clinical studies and clinical trials vary significantly over the life of a project and are difficult to predict, a market participant would assume that it would take several years to complete each phase of clinical trials for a drug candidate for the treatment of patients with HCV and that future cash flows, if any, would not be generated until a drug candidate had completed all required phases of clinical trials and had obtained regulatory approval. The risk-adjusted discount rate for each of these projects was approximately 28%.
Initially, the in-process research and development assets were recorded at fair value and accounted for as indefinite-lived intangible assets. We will maintain each of these assets on our condensed consolidated balance sheets until either the research and development project underlying it is completed or the asset becomes impaired. If a project is completed, the carrying value of the related intangible asset would be amortized over the remaining estimated life of the asset. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset would be written down to its fair value and an impairment charge would be taken in the period in which the impairment occurs. In order to complete an acquired research and development project, the related drug candidate must
39
be evaluated in later-stage clinical trials, which are subject to all of the risks and uncertainties associated with the development of pharmaceutical products. If the fair value of any of these drug candidates, and in particular VX-222, becomes impaired as the result of unfavorable safety or efficacy data from any ongoing or future clinical trial or because of any other information regarding the prospects of successfully developing or commercializing the drug candidate, we could incur significant charges in the period in which the impairment occurs. These intangible assets will be tested for impairment on an annual basis during the fourth quarter, or earlier if impairment indicators are present. Post-acquisition research and development expenses related to the in-process research and development projects will be expensed as incurred.
September 2009 Financial Transactions
The two financial transactions that we entered into in September 2009 involved the issuance of the 2012 Notes, which are secured by $155.0 million of potential future telaprevir milestone payments that we are eligible to receive from Janssen, and the sale of $95.0 million in additional potential future telaprevir milestone payments that we are eligible to receive from Janssen. We sold the 2012 Notes, which have a face value of $155.0 million and do not carry an explicit interest rate, for $122.2 million. The 2012 Notes contain an embedded derivative related to their potential early repayment or redemption. The liability related to the separate sale of the potential $95.0 million in future milestone payments for $32.8 million is accounted for as a free-standing derivative instrument.
In order to account for the 2012 Notes and the sale of the rights to the potential future milestone payments, we were required to estimate the fair value of the derivative embedded in the 2012 Notes and of the rights to the $95.0 million in potential future milestones. The models we used to estimate these fair values require estimates regarding, among other things, the assumptions a market participant would make regarding the timing and probability of achieving the milestones and the appropriate discount rates.
2012 Notes
The 2012 Notes have an estimated initial residual value of $108.2 million, which excludes the value of the embedded derivative. The embedded derivative associated with the 2012 Notes has an estimated fair value of $10.7 million. In future periods, we expect that we will record a quarterly interest expense determined using the effective interest rate method, which will increase the amount of the liability for our 2012 Notes each quarter by an amount corresponding to this interest expense through the stated maturity date, unless redeemed or repaid earlier. In addition, we will evaluate the embedded derivative for changes in fair value on at least a quarterly basis. We expect that the net expense related to the 2012 Notes that we will recognize based on interest expense and gains and losses on the embedded derivative over the period between October 1, 2009 and October 31, 2012 will equal $36.2 million, which is the difference between the $155.0 million face value of the 2012 Notes and the $118.8 million initial estimated value of the 2012 Notes, including the value of the embedded derivative, on the issuance date. However, the timing of these expenses or any gains will depend on a number of factors related to the probability and timing of achieving the relevant milestone events and discount rates and could result in material expenses or gains in any quarterly period.
Sale of Potential Future Milestones
The fair value of the free-standing derivative instrument created by the sale of the rights to the $95.0 million of future milestone payments was estimated to be $36.2 million. We will evaluate this free-standing derivative for changes in fair value on at least a quarterly basis. Any change in the value of this free-standing derivative will be recorded as a loss or gain in the period in which it becomes known. If these milestone events are achieved, we expect that we will recognize net expenses over the period between October 1, 2009 and the date the milestones are achieved equal to $58.8 million, which
40
is the difference between the $95.0 million the purchaser would receive if all the milestone events are achieved and the fair value of the free-standing derivative on the issuance date. Because our estimate of the fair value of the free-standing derivative includes the application of a discount rate to reflect the time-value of money, we expect to record interest costs related to this liability balance each quarter. However, the timing of other expenses or any gains will depend on a number of factors related to the probability and timing of achieving the relevant milestone events and discount rates and could result in material expenses or gains in any quarterly period.
Up-front License Fees
We recognize revenues from nonrefundable, up-front license fees related to collaboration agreements, including the $165.0 million we received from Janssen in 2006 and the $105.0 million we received from Mitsubishi Tanabe in the third quarter of 2009, on a straight-line basis over the contracted or estimated period of performance. The period of performance over which the revenues are recognized is typically the period over which the research and/or development is expected to occur. As a result, we often are required to make estimates regarding drug development and commercialization timelines for compounds being developed pursuant to a collaboration agreement. Because the drug development process is lengthy and our collaboration agreements typically cover activities over several years, this approach often has resulted in the deferral of significant amounts of revenue into future periods. In addition, we periodically evaluate our estimates in light of changes and anticipated changes in the development plans for our drug candidates and because of the many risks and uncertainties associated with the development of drug candidates, our estimates regarding the period of performance have changed in the past and may change in the future. Our estimates regarding the period of performance under the Janssen collaboration agreement were adjusted in 2007 and in the third quarter of 2009 as a result of changes in the global development plan for telaprevir, including activities that are expected to be conducted in the post-approval period. These adjustments were made on a prospective basis beginning in the period in which the change was identified. These adjustments resulted in a decrease in the amount of revenues we were recognizing from the Janssen collaboration by $2.6 million per quarter for the first adjustment and $1.1 million per quarter for the second adjustment. Any future adjustment in our estimates of the period of performance under our collaborations could result in substantial changes to the period over which the revenues from an up-front license fee related to each such collaboration are recognized. If we adjust our estimates as of October 1, 2009 to increase the period of performance under the Janssen agreement by one year, it would result in a decrease in the amount of deferred revenues we recognize from our Janssen collaboration of approximately $0.8 million per quarter beginning in the fourth quarter of 2009.
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Results of OperationsThree and Nine Months Ended September 30, 2009 Compared with Three and Nine Months Ended September 30, 2008
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Three Months Ended September 30, |
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Revenues |
$ | 24,957 | $ | 31,609 | $ | (6,652 | ) | (21 | )% | $ | 68,000 | $ | 142,693 | $ | (74,693 | ) | (52 | )% | |||||||
Costs and expenses |
173,190 | 162,237 | 10,953 | 7 | % | 535,293 | 463,538 | 71,755 | 15 | % | |||||||||||||||
Other income (expense) |
(1,332 | ) | 584 | (1,916 | ) | n/a | (16,241 | ) | 3,326 | (19,567 | ) | n/a | |||||||||||||
Net loss |
$ | (149,565 | ) | $ | (130,044 | ) | $ | 19,521 | 15 | % | $ | (483,534 | ) | $ | (317,519 | ) | $ | 166,015 | 52 | % | |||||
Net Loss
In the three months ended September 30, 2009 as compared to the three months ended September 30, 2008, our net loss increased by $19.5 million, or 15%. In the nine months ended September 30, 2009 as compared to the nine months ended September 30, 2008, our net loss increased by $166.0 million, or 52%. The increases in net loss in the three and nine months ended September 30, 2009 as compared to the three and nine months ended September 30, 2008 were the result of significant increases in costs and expenses combined with decreases in our revenues. Our lower revenues in the three and nine months ended September 30, 2009 were primarily the result of milestone payments that we recognized in the 2008 periods for which there were no corresponding milestone payments in 2009 periods. The increased expenses included increased operating expenses related to the increased size of our workforce and to our late-stage clinical programs and increased stock-based compensation expense. In addition, in the second quarter of 2009, we had a $12.3 million non-cash expense on the exchange of a portion of the 2013 Notes into our common stock and in the first half of 2009 we had $7.8 million of acquisition-related expenses from our acquisition of ViroChem and additional expenses related to our management transition.
Net Loss per Share
Our net loss for the three months ended September 30, 2009 was $0.84 per basic and diluted common share compared to $0.93 per basic and diluted common share for the three months ended September 30, 2008. Our net loss for the nine months ended September 30, 2009 was $2.86 per basic and diluted common share compared to $2.30 per basic and diluted common share for the nine months ended September 30, 2008. The decrease in net loss per common share in the third quarter of 2009 compared to the third quarter of 2008 was the result of an increase in the basic and diluted weighted-average number of common shares outstanding in the third quarter of 2009 compared to the third quarter of 2008 partially offset by an increased net loss in the third quarter of 2009 compared to the third quarter of 2008. The increase in net loss per common share in the nine months ended September 30, 2009 compared to the same period in 2008 was the result of the increased net loss in the nine months ended September 30, 2009 partially offset by an increase in the basic and diluted weighted-average number of common shares outstanding in 2009. The increases in the weighted-average number of common shares outstanding in 2009 were primarily the result of the equity offerings in September 2008 and February 2009, the issuance of shares for our acquisition of ViroChem in March 2009 and the issuance of shares in the debt exchange we conducted in June 2009. Our basic and diluted weighted-average number of common shares outstanding increased from 140.1 million in the three months ended September 30, 2008 to 178.7 million in the three months ended September 30, 2009 and from 137.8 million in the nine months ended September 30, 2008 to 169.1 million in the nine months ended September 30, 2009.
42
Stock-based Compensation, Restructuring and Acquisition-related Expenses and 2013 Note Exchange
The comparison of our costs and expenses in the 2009 periods and the 2008 periods is affected by increases in our stock-based compensation expense and our restructuring expense as well as expenses related to our acquisition of ViroChem in March 2009, and the exchange of a portion of the 2013 Notes into our common stock in June 2009. Our costs and expenses in the three and nine months ended September 30, 2009 and 2008 included:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | 2009 | 2008 | |||||||||
|
(in thousands) |
||||||||||||
Stock-based compensation expense |
$ | 20,134 | $ | 14,485 | $ | 68,996 | $ | 44,150 | |||||
Restructuring expense |
774 | 885 | 4,283 | 2,683 | |||||||||
Acquisition-related expenses |
| | 7,793 | | |||||||||
Loss on exchange of a portion of the 2013 Notes |
| | 12,294 | |
Revenues
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
||||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | ||||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||||||||||
Royalty revenues |
$ | 7,834 | $ | 7,763 | $ | 71 | 1 | % | $ | 19,891 | $ | 28,355 | $ | (8,464 | ) | (30 | )% | |||||||||
Collaborative and other research and development revenues |
17,123 | 23,846 | (6,723 | ) | (28 | )% | 48,109 | 114,338 | (66,229 | ) | (58 | )% | ||||||||||||||
Total revenues |
$ | 24,957 | $ | 31,609 | $ | (6,652 | ) | (21 | )% | $ | 68,000 | $ | 142,693 | $ | (74,693 | ) | (52 | )% | ||||||||
Our total revenues in recent periods have consisted primarily of collaborative and other research and development revenues. On a quarterly basis our collaborative and other research and development revenues have fluctuated significantly based on the timing of recognition of significant milestone payments and the level of reimbursement we have received under our collaboration agreements for our development programs. If we are able to successfully commercialize telaprevir in accordance with current development timelines, we anticipate revenues and cash flows from the sales of telaprevir to commence in 2011.
Collaborative and Other Research and Development Revenues
The table presented below is a summary of revenues from collaborative arrangements for the three and nine months ended September 30, 2009 and 2008:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2009 | 2008 | 2009 | 2008 | ||||||||||
|
(in thousands) |
|||||||||||||
Janssen |
$ | 10,232 | $ | 15,239 | $ | 40,157 | $ | 98,725 | ||||||
Mitsubishi Tanabe |
6,891 | 2,129 | 7,734 | 7,889 | ||||||||||
Merck |
| 6,000 | | 6,000 | ||||||||||
Other |
| 478 | 218 | 1,724 | ||||||||||
Total collaborative and other research and development revenues |
$ | 17,123 | $ | 23,846 | $ | 48,109 | $ | 114,338 | ||||||
Our revenues from the Janssen collaboration in each period consist of:
43
The $5.0 million, or 33%, decrease in our revenues from Janssen in the third quarter of 2009 compared to the third quarter of 2008 was primarily the result of our decreased reimbursable expenses related to the telaprevir clinical development program. The $58.6 million, or 59%, decrease in our revenues from Janssen in the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily the result of a decrease in milestone payments from our Janssen collaboration. We recognized a total of $55.0 million in milestone payments in the nine months ended September 30, 2008 for which there were no corresponding milestone payments in the nine months ended September 30, 2009. In the third quarter of 2009, we entered into two financial transactions related to $250.0 million in potential future milestone payments associated with the regulatory filing and approval for telaprevir from the European Medicines Evaluation Agency and the launch of telaprevir in the European Union. We expect that, when and if earned, these milestones will result in collaborative revenues of which the proceeds from the first $155.0 million would be used to redeem the 2012 Notes and the remaining $95.0 million would be provided to the purchaser of these milestone payments.
In the three months ended September 30, 2009, our collaborative revenues from sources other than Janssen related primarily to our collaboration with Mitsubishi Tanabe. On July 30, 2009, we entered into an amendment to our license, development and commercialization agreement with Mitsubishi Tanabe that provided for a $105.0 million payment in connection with the execution of the amendment. This payment was initially classified as deferred revenues and is being recognized over our expected period of performance. In the three months ended September 30, 2009, we recognized a total of $6.9 million of revenues from Mitsubishi Tanabe, including the amortized portion of the $105.0 million upfront payment. In the three months ended September 30, 2008, our collaborative revenue from sources other than Janssen related primarily to the $6.0 million milestone we achieved pursuant to our collaboration with Merck for which there was no corresponding milestone payment in the three months ended September 30, 2009.
Royalty Revenues
Our royalty revenues relate to sales of the HIV protease inhibitors Lexiva/Telzir and Agenerase by GlaxoSmithKline plc. Until May 30, 2008, these royalty revenues were based on actual and estimated worldwide net sales of Lexiva/Telzir and Agenerase. On May 30, 2008, we sold our right to receive future royalties from GlaxoSmithKline plc with respect to these HIV protease inhibitors, excluding the portion allocated to pay a subroyalty on these net sales to a third party, in return for a one-time cash payment of $160.0 million. We deferred the recognition of $155.1 million of revenues from this sale. We are recognizing these deferred revenues over the term of our agreement with GlaxoSmithKline plc under the units-of-revenue method. We will also continue to recognize royalty revenues equal to the amount of the third-party subroyalty and an offsetting royalty expense for the third-party subroyalty payment.
Our royalty revenues were $7.8 million in both the third quarter of 2009 and the third quarter of 2008. The $8.5 million, or 30%, decrease in royalty revenues in the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 resulted primarily from this sale of our future HIV royalties in the second quarter of 2008. In 2009, we expect that we will continue to recognize as royalty revenues a portion of the remaining deferred revenues from the sale of our HIV royalty stream plus the full amount of the third-party subroyalty.
44
Costs and Expenses
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
||||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | ||||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||||||||||
Royalty expenses |
$ | 3,712 | $ | 4,194 | $ | (482 | ) | (11 | )% | $ | 10,555 | $ | 11,471 | $ | (916 | ) | (8 | )% | ||||||||
Research and development expenses |
132,132 | 131,728 | 404 | 0 | % | 415,044 | 377,574 | 37,470 | 10 | % | ||||||||||||||||
Sales, general and administrative expenses |
36,572 | 25,430 | 11,142 | 44 | % | 97,618 | 71,810 | 25,808 | 36 | % | ||||||||||||||||
Restructuring expense |
774 | 885 | (111 | ) | (13 | )% | 4,283 | 2,683 | 1,600 | 60 | % | |||||||||||||||
Acquisition-related expenses |
| | | n/a | 7,793 | | 7,793 | n/a | ||||||||||||||||||
Total costs and expenses |
$ | 173,190 | $ | 162,237 | $ | 10,953 | 7 | % | $ | 535,293 | $ | 463,538 | $ | 71,755 | 15 | % | ||||||||||
Our operating costs and expenses primarily relate to our research and development expenses and our sales, general and administrative expenses. Our research and development expenses fluctuate on a quarterly basis due to the timing of activities related to the development of clinical drug candidates. Our sales, general and administrative expenses generally have been increasing as a result of expanding our commercial capabilities in preparation for the potential commercial launch of telaprevir.
Research and Development Expenses
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
||||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | ||||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||||||||||
Research expenses |
$ | 42,663 | $ | 41,567 | $ | 1,096 | 3 | % | $ | 129,418 | $ | 123,382 | $ | 6,036 | 5 | % | ||||||||||
Development expenses |
89,469 | 90,161 | (692 | ) | (1 | )% | 285,626 | 254,192 | 31,434 | 12 | % | |||||||||||||||
Total research and development expenses |
$ | 132,132 | $ | 131,728 | $ | 404 | 0 | % | $ | 415,044 | $ | 377,574 | $ | 37,470 | 10 | % | ||||||||||
Our total research and development expenses were similar in the third quarter of 2009 and the third quarter of 2008 as increases in the expenses related to our workforce were offset by decreases in third-party contractual services and investment in commercial supply of telaprevir. The $37.5 million increase in our total research and development expenses in the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily the result of increases in expenses related to our workforce.
Our research and development expenses include internal and external costs incurred for our drug candidates, including telaprevir and VX-770. We do not assign to individual drug candidates our internal costs such as salary and benefits, stock-based compensation expense, laboratory supplies and infrastructure costs because the employees within our research and development groups typically are deployed across multiple research and development programs. These internal costs are significantly greater than our external costs, such as the costs of services provided to us by clinical research organizations and other outsourced research, which we do allocate by individual drug development program. All research and development costs for our drug candidates are expensed as incurred.
To date, we have incurred in excess of $3.2 billion in research and development expenses associated with drug discovery and development. The successful development of our drug candidates is highly uncertain and subject to a number of risks. In addition, the duration of clinical trials may vary substantially according to the type, complexity and novelty of the drug candidate. The FDA and comparable agencies in foreign countries impose substantial requirements on the introduction of
45
therapeutic pharmaceutical products, typically requiring lengthy and detailed laboratory and clinical testing procedures, sampling activities and other costly and time-consuming procedures. Data obtained from nonclinical and clinical activities at any step in the testing process may be adverse and lead to discontinuation or redirection of development activity. Data obtained from these activities also are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The duration and cost of discovery, nonclinical studies and clinical trials may vary significantly over the life of a project and are difficult to predict. Therefore, accurate and meaningful estimates of the ultimate costs to bring our drug candidates to market are not available.
Our lead drug candidate telaprevir represents the largest portion of our development costs for our clinical drug candidates. Based on the completion of enrollment of our Phase 3 clinical trials of telaprevir in February 2009, we anticipate that our ongoing Phase 3 clinical trials will be completed in mid-2010, but that development costs associated with other clinical trials of telaprevir may continue after the completion of the registration trials. If we are able to successfully commercialize telaprevir in accordance with current development timelines, we anticipate revenues and cash flows from the sales of telaprevir to commence in 2011. Our other drug candidates are less advanced and as a result any estimates regarding development timelines for these drug candidates are highly subjective and subject to change, and we cannot at this time make a meaningful estimate when, if ever, these drug candidates, including the drug candidates we acquired from ViroChem, will generate revenues and cash flows.
Research Expenses
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
|||||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | |||||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
|||||||||||||||||||||||
Research Expenses: |
|||||||||||||||||||||||||||
Salary and benefits |
$ | 16,631 | $ | 14,372 | $ | 2,259 | 16 | % | $ | 46,751 | $ | 41,287 | $ | 5,464 | 13 | % | |||||||||||
Stock-based compensation expense |
5,152 | 4,660 | 492 | 11 | % | 18,757 | 14,288 | 4,469 | 31 | % | |||||||||||||||||
Laboratory supplies and other direct expenses |
6,266 | 5,792 | 474 | 8 | % | 20,549 | 18,120 | 2,429 | 13 | % | |||||||||||||||||
Contractual services |
1,498 | 1,683 | (185 | ) | (11 | )% | 3,844 | 6,232 | (2,388 | ) | (38 | )% | |||||||||||||||
Infrastructure costs |
13,116 | 15,060 | (1,944 | ) | (13 | )% | 39,517 | 43,455 | (3,938 | ) | (9 | )% | |||||||||||||||
Total research expenses |
$ | 42,663 | $ | 41,567 | $ | 1,096 | 3 | % | $ | 129,418 | $ | 123,382 | $ | 6,036 | 5 | % | |||||||||||
The $1.1 million and $6.0 million increases in total research expenses in the three and nine months ended September 30, 2009, respectively, compared to the same periods in 2008 were the result of increased expenses related to our workforce partially offset by decreased contractual services and infrastructure costs.
46
Development Expenses
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
|||||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | |||||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
|||||||||||||||||||||||
Development Expenses: |
|||||||||||||||||||||||||||
Salary and benefits |
$ | 26,963 | $ | 20,878 | $ | 6,085 | 29 | % | $ | 73,399 | $ | 57,034 | $ | 16,365 | 29 | % | |||||||||||
Stock-based compensation expense |
7,896 | 6,763 | 1,133 | 17 | % | 32,185 | 21,104 | 11,081 | 53 | % | |||||||||||||||||
Laboratory supplies and other direct expenses |
6,996 | 7,483 | (487 | ) | (7 | )% | 20,819 | 22,684 | (1,865 | ) | (8 | )% | |||||||||||||||
Contractual services |
25,526 | 28,214 | (2,688 | ) | (10 | )% | 88,703 | 81,800 | 6,903 | 8 | % | ||||||||||||||||
Commercial supply investment in telaprevir |
4,179 | 6,461 | (2,282 | ) | (35 | )% | 14,290 | 15,268 | (978 | ) | (6 | )% | |||||||||||||||
Infrastructure costs |
17,909 | 20,362 | (2,453 | ) | (12 | )% | 56,230 | 56,302 | (72 | ) | 0 | % | |||||||||||||||
Total development expenses |
$ | 89,469 | $ | 90,161 | $ | (692 | ) | (1 | )% | $ | 285,626 | $ | 254,192 | $ | 31,434 | 12 | % | ||||||||||
Our development expenses decreased by $0.7 million in the third quarter of 2009 compared to the third quarter of 2008 primarily because increases in expenses related to our workforce were offset by decreases in our other development expenses as external expenses related to the registration program for telaprevir decreased. Our development expenses increased in the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 primarily as a result of increased expenses related to our workforce. The number of employees in our development group increased by approximately 15% from the third quarter of 2008 to the third quarter of 2009 and by approximately 19% from the first nine months of 2008 compared to the first nine months of 2009. Our contractual services expenses, which fluctuate significantly from quarter to quarter based on the timing of activities related to our clinical trials, decreased in the third quarter of 2009 compared to the third quarter of 2008, but increased in the first nine months of 2009 compared to the first nine months of 2008. We expect our contractual services expenses to continue to fluctuate significantly because as the contractual services costs associated with our telaprevir registration program decrease we expect the contractual services costs associated with our other drug development candidates will increase.
47
Sales, General and Administrative Expenses
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
Increase/ (Decrease) $ |
Increase/ (Decrease) % |
|||||||||||||||||||||
|
2009 | 2008 | 2009 | 2008 | |||||||||||||||||||||
|
(in thousands) |
|
(in thousands) |
|
|||||||||||||||||||||
Sales, general and administrative expenses |
$ | 36,572 | $ | 25,430 | $ | 11,142 | 44 | % | $ | 97,618 | $ | 71,810 | $ | 25,808 | 36 | % |
The increases in sales, general and administrative expenses in the three and nine months ended September 30, 2009 compared to the same periods in 2008 are the result of increased headcount as we advance our drug candidates, particularly telaprevir, into late-stage development and prepare for the potential commercial launch of telaprevir. In the three months ended September 30, 2009 and 2008, our sales, general and administrative expenses included $7.1 million and $3.1 million, respectively, of stock-based compensation expense. In the nine months ended September 30, 2009 and 2008, our sales, general and administrative expenses included $18.1 million and $8.8 million, respectively, of stock-based compensation expense.
Royalty Expenses
Royalty expenses decreased in the three and nine months ended September 30, 2009 as compared to the three and nine months ended September 30, 2008. Royalty expenses primarily relate to a subroyalty payable to a third party on net sales of Lexiva/Telzir and Agenerase. The subroyalty results in both a royalty expense and corresponding royalty revenues. We expect to continue to recognize this subroyalty as an expense in future periods.
Restructuring Expense
We recorded restructuring expense of $0.8 million for the three months ended September 30, 2009 compared to $0.9 million for the three months ended September 30, 2008. We recorded restructuring expense of $4.3 million for the nine months ended September 30, 2009 compared to $2.7 million for the nine months ended September 30, 2008. The restructuring expense in all periods includes imputed interest cost related to the restructuring liability associated with our Kendall Square lease. The increase in restructuring expense for the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily the result of a revision, in the first quarter of 2009, of certain key estimates and assumptions about facility operating costs for the remaining period of the lease commitment, for which there was no corresponding revision in the nine months ended September 30, 2008. The lease restructuring liability was $33.4 million as of September 30, 2009.
We review our estimates and assumptions with respect to the Kendall Square lease on at least a quarterly basis, and will make whatever modifications we believe are necessary to reflect any changed circumstances, based on our best judgment, until the termination of the lease. Our estimates have changed in the past, and may change in the future, resulting in additional adjustments to the estimate of the liability, and the effect of any such adjustments could be material.
Acquisition-related Expenses
We incurred $7.8 million of expenses in the nine months ended September 30, 2009, all in the first quarter, in connection with our acquisition of ViroChem, including $5.7 million in transaction expenses and $2.1 million related to a restructuring of ViroChem's operations that we undertook in March 2009 in order to focus ViroChem's activities on its HCV assets. We did not have corresponding acquisition-related expenses in the nine months ended September 30, 2008.
48
Non-operating ItemsOther Income (Expense)
Interest income decreased by $3.8 million, or 86%, to $0.6 million for the three months ended September 30, 2009 from $4.4 million for the three months ended September 30, 2008. Interest income decreased by $8.2 million, or 64%, to $4.7 million for the nine months ended September 30, 2009 from $12.9 million for the nine months ended September 30, 2008. The decrease was a result of lower portfolio yields during the 2009 periods as compared to the 2008 periods. Our cash, cash equivalents and marketable securities yielded approximately 0% on an annual basis in the third quarter of 2009 compared to approximately 2% on an annual basis in the third quarter of 2008.
Interest expense decreased by $1.9 million, or 49%, to $1.9 million for the three months ended September 30, 2009 from $3.8 million for the three months ended September 30, 2008. Interest expense was $8.6 million and $9.6 million, respectively, for the nine months ended September 30, 2009 and 2008. We recorded interest expense of $2.1 million on the $143.5 million in aggregate principal amount of 2013 Notes that were exchanged in June 2009 through the date on which we entered into the exchange agreements with respect to such 2013 Notes. Our outstanding principal amount of 2013 Notes decreased from $287.5 million on March 31, 2009 to $144.0 million on September 30, 2009. In future periods, we expect that we will incur interest expense related to the 2012 Notes that we issued in September 2009 and potential gains or losses on the embedded derivative related to the 2012 Notes and the free-standing derivative related to the sale of the potential future milestones.
In the nine months ended September 30, 2009, we incurred a non-cash charge of $12.3 million in connection with the exchange of $143.5 million in aggregate principal amount of the 2013 Notes for 6.6 million newly-issued shares of our common stock. The charge related to the additional approximately 400,000 shares of common stock that we issued in excess of the number of shares of common stock into which such 2013 Notes were convertible prior to the exchange.
Liquidity and Capital Resources
We have incurred operating losses since our inception and have financed our operations principally through public and private offerings of our equity and debt securities, strategic collaborative agreements that include research and/or development funding, development milestones and royalties on the sales of products, strategic sales of assets or businesses, investment income and proceeds from the issuance of common stock under our employee benefit plans. We expect that we will require additional capital in order to commercialize telaprevir and continue our planned activities in other areas.
At September 30, 2009, we had cash, cash equivalents and marketable securities of $856.6 million, which was an increase of $24.5 million from $832.1 million at December 31, 2008. The increase was primarily the result of financing activities, financial transactions and payments from collaborators that occurred in the nine months ended September 30, 2009, including $313.3 million of net proceeds from the offering of common stock that we completed in February 2009, $122.2 million of gross proceeds that we received from a third party in September 2009 for the sale of our 2012 Notes, the $105.0 million payment we received from Mitsubishi Tanabe in the third quarter of 2009 and $25.0 million from the issuance of common stock under our employee benefits plans. These cash inflows were offset by cash expenditures we made in the nine months ended September 30, 2009 related to, among other things, research and development expenses and sales, general and administrative expenses, $100.0 million in cash that we paid for ViroChem, and the timing of payments to our vendors. Capital expenditures for property and equipment during the nine months ended September 30, 2009 were $15.9 million.
During the nine months ended September 30, 2009, we reduced the aggregate principal amount of our 2013 Notes outstanding from $287.5 million to $144.0 million. The 2013 Notes bear interest at the rate of 4.75% per annum, and we are required to make semi-annual interest payments on the outstanding principal balance of the 2013 Notes on February 15 and August 15 of each year. The 2013
49
Notes will mature on February 15, 2013. The 2013 Notes are convertible, at the option of the holder, into our common stock at a price equal to approximately $23.14 per share, subject to adjustment. On or after February 15, 2010, we may redeem the 2013 Notes at our option, in whole or in part, at the redemption prices stated in the indenture related to the 2013 Notes, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
As a result of a financial transaction entered into on September 30, 2009, we have outstanding $155.0 million in aggregate principal amount of 2012 Notes that mature on October 31, 2012, subject to earlier mandatory redemption as specified milestone events under our collaboration with Janssen are achieved, if at all, prior to October 31, 2012. In addition, on September 30, 2009, we sold our rights to receive an additional $95.0 million of potential future milestone payments that we are eligible to receive from Janssen for the launch of telaprevir in the Europe Union. As a result of these transactions, the $250.0 million of potential milestone payments from Janssen related to the filing, approval and launch of telaprevir in the European Union will not provide us with liquidity in the future, if and when earned, except to the extent that they provide for the mandatory redemption of $155.0 million in principal amount of our 2012 Notes.
Our accrued restructuring expense of $33.4 million at September 30, 2009 relates to the portion of the facility that we lease in Kendall Square that we do not intend to occupy and includes other related lease obligations, recorded at net present value. In the nine months ended September 30, 2009, we made cash payments of $11.5 million against the accrued expense and received $6.5 million in sublease rental payments. During the fourth quarter of 2009, we expect to make additional cash payments of $3.7 million against the accrued expense and receive $2.0 million in sublease rental payments.
We expect to continue to make significant investments in our development pipeline, particularly in clinical trials of telaprevir, in our effort to prepare for potential registration, regulatory approval and commercial launch of telaprevir, and in clinical trials for our other drug candidates, including VX-770, VX-809, VX-222 and VX-509. We also expect to maintain our substantial investment in research. As a result, we expect to incur future losses on a quarterly and annual basis. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including the number, breadth and prospects of our discovery and development programs, the costs and timing of obtaining regulatory approvals for any of our drug candidates and our decisions regarding manufacturing and commercial investments.
We believe that our current cash, cash equivalents and marketable securities, in addition to amounts we expect to receive from our collaborators under existing contractual obligations, will be sufficient to fund our operations for at least the next twelve months. We expect that we will need additional capital in order to complete the development and commercialization of telaprevir and to continue the development of our other drug candidates, including VX-770. We may raise additional capital through public offerings or private placements of our securities, securing new collaborative agreements, or other methods of financing. Any such capital transactions may or may not be similar to transactions in which we have engaged in the past. We also will continue to manage our capital structure and consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all. If adequate funds are not available, we may be required to curtail significantly or discontinue one or more of our research, drug discovery or development programs or attempt to obtain funds through arrangements that may require us to relinquish rights to certain of our technologies or drug candidates.
Contractual Commitments and Obligations
Our commitments and obligations were reported in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission, or SEC, on
50
February 17, 2009. There have been no material changes from the contractual commitments and obligations previously disclosed in that Annual Report on Form 10-K, except that:
Recent Accounting Pronouncements
Refer to Note 17, "Recent Accounting Pronouncements," in the accompanying notes to the condensed consolidated financial statements for a discussion of recent accounting pronouncements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital until it is required to fund operations, including our research and development activities. None of these market risk-sensitive instruments are held for trading purposes. We do not have derivative financial instruments in our investment portfolio.
Interest Rate Risk
We invest our cash in a variety of financial instruments, principally securities issued by the United States government and its agencies, investment grade commercial paper and money market funds. These investments are denominated in United States dollars. All of our interest-bearing securities are subject to interest rate risk, and could decline in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments. Due to the conservative nature of these instruments, we do not believe that we have a material exposure to interest rate risk.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our chief executive officer and chief financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, as of September 30, 2009 our disclosure controls and procedures were effective and designed to provide reasonable assurance that the information required to be disclosed is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well
51
designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Controls Over Financial Reporting
We completed two financial transactions on September 30, 2009 that involved the issuance of the 2012 Notes and a sale of potential future milestone payments. The accounting for these two transactions is material to our financial position as of September 30, 2009 and we believe the internal controls and procedures relating to the accounting for the derivatives resulting from the transactions have a material effect on our internal control over financial reporting. See Note 13, "September 2009 Financial Transactions", to our unaudited condensed consolidated financial statements contained in this Quarterly Report for further details on these transactions.
We have expanded our Section 404 compliance program under the Sarbanes-Oxley Act of 2002 and the applicable rules and regulations under this act to include current and on-going accounting for these derivatives. Except for the accounting for these derivatives, no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended) occurred during the third quarter of 2009 that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.
52
Information regarding risk factors appears in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the SEC on February 17, 2009, as updated by our Quarterly Report on Form 10-Q for the three months ended March 31, 2009, which was filed with the SEC on May 11, 2009. There have been no material changes from the risk factors previously disclosed in the Form 10-K as updated by the Form 10-Q.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q and, in particular, our Management's Discussion and Analysis of Financial Condition and Results of Operations set forth in Part IItem 2, contain or incorporate a number of forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding:
53
Without limiting the foregoing, the words "believes," "anticipates," "plans," "intends," "expects" and similar expressions are intended to identify forward-looking statements. Any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Many factors mentioned in our discussion in this Quarterly Report on Form 10-Q will be important in determining future results. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially from expected results. We also provide a cautionary discussion of risks and uncertainties under "Risk Factors" in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the SEC on February 17, 2009, and updated and supplemented by "Part IIItem 1ARisk Factors" of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, which was filed with the SEC on May 11, 2009. These are factors that we think could cause our actual results to differ materially from expected results. Other factors besides those listed could also adversely affect us. In addition, the forward-looking statements contained herein represent our estimate only as of the date of this filing and should not be relied upon as representing our estimate as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking statements.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Repurchases of Equity Securities
The table set forth below shows all repurchases of securities by us during the three months ended September 30, 2009:
Period
|
Total Number of Shares Purchased |
Average Price Paid per Share |
Total Number of Shares Purchased as part of publicly announced Plans or Programs |
Maximum Number of Shares that may yet be purchased under publicly announced Plans or Programs |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
July 1, 2009 to July 31, 2009 |
12,177 | $ | 0.01 | | | ||||||||
August 1, 2009 to August 31, 2009 |
11,316 | $ | 0.01 | | | ||||||||
September 1, 2009 to September 30, 2009 |
9,418 | $ | 0.01 | | |
The repurchases were made under the terms of our 1996 Stock and Option Plan and 2006 Stock and Option Plan. Under these plans, we award shares of restricted stock that typically are subject to a lapsing right of repurchase by us. We may exercise this right of repurchase in the event that a restricted stock recipient's service to us is terminated. If we exercise this right, we are required to repay the
54
purchase price paid by or on behalf of the recipient for the repurchased restricted shares, which typically is the par value per share of $0.01. Repurchased shares are returned to the applicable Stock and Option Plan under which they were issued. Shares returned to the 2006 Stock and Option Plan are available for future awards under the terms of that plan.
Exhibit No. | Description | ||
---|---|---|---|
4.1 | Indenture dated as of September 30, 2009 by and between Vertex Pharmaceuticals Incorporated and U.S. Bank National Association, as trustee and collateral agent. | ||
4.2 |
Secured Note due 2012. |
||
10.1 |
License, Development and Commercialization Agreement between Mitsubishi Tanabe Pharma Corporation and Vertex Pharmaceuticals Incorporated, dated June 11, 2004. |
||
10.2 |
Second Amendment dated July 30, 2009 to License, Development and Commercialization Agreement between Mitsubishi Tanabe Pharma Corporation and Vertex Pharmaceuticals Incorporated. |
||
10.3 |
Note Purchase Agreement dated September 30, 2009 by and between Vertex Pharmaceuticals Incorporated and Olmsted Park S.A. |
||
10.4 |
Security Agreement dated September 30, 2009 between Vertex Pharmaceuticals Incorporated and U.S. Bank National Association, as collateral agent. |
||
10.5 |
Purchase Agreement Regarding Milestone #9 dated September 30, 2009 by and between Vertex Pharmaceuticals Incorporated and Olmsted Park S.A. |
||
10.6 |
Purchase Agreement Regarding Milestone #10 dated September 30, 2009 by and between Vertex Pharmaceuticals Incorporated and Olmsted Park S.A. |
||
31.1 |
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
||
31.2 |
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
||
32.1 |
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
55
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
November 9, 2009 | VERTEX PHARMACEUTICALS INCORPORATED | |||
By: |
/s/ IAN F. SMITH Ian F. Smith Executive Vice President and Chief Financial Officer (principal financial officer and duly authorized officer) |
56
Exhibit 4.1
EXECUTION COPY
Confidential Treatment Requested.
Confidential
portions of this document have been redacted and have been separately
filed with the Commission.
VERTEX PHARMACEUTICALS INCORPORATED
$155,000,000
SECURED NOTES DUE 2012
INDENTURE
DATED AS OF SEPTEMBER 30, 2009
U.S. BANK NATIONAL ASSOCIATION,
AS TRUSTEE AND COLLATERAL AGENT
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Table of Contents
|
Page |
|
|
|
|
LIST OF EXHIBITS |
V |
|
|
|
|
ARTICLE I. DEFINITIONS AND INCORPORATION BY REFERENCE |
1 |
|
Section 1.01. |
Definitions |
1 |
Section 1.02. |
Incorporation by Reference of Trust Indenture Act |
14 |
Section 1.03. |
Rules of Construction |
14 |
|
|
|
ARTICLE II. THE NOTES |
15 |
|
Section 2.01. |
Form and Dating |
15 |
Section 2.02. |
Execution and Authentication |
16 |
Section 2.03. |
Registrar and Paying Agent |
16 |
Section 2.04. |
Paying Agent to Hold Money in Trust |
17 |
Section 2.05. |
Holder Lists |
17 |
Section 2.06. |
Transfer and Exchange |
17 |
Section 2.07. |
Replacement Notes |
33 |
Section 2.08. |
Outstanding Notes |
33 |
Section 2.09. |
Treasury Notes |
34 |
Section 2.10. |
Temporary Notes |
34 |
Section 2.11. |
Cancellation |
34 |
Section 2.12. |
Defaulted Interest |
34 |
|
|
|
ARTICLE III. REDEMPTION AND PREPAYMENT |
35 |
|
Section 3.01. |
Notices to Trustee |
35 |
Section 3.02. |
Selection of Notes to Be Redeemed |
35 |
Section 3.03. |
Notice of Redemption |
36 |
Section 3.04. |
Effect of Notice of Redemption |
37 |
Section 3.05. |
Deposit of Redemption Price |
37 |
Section 3.06. |
Notes Redeemed in Part |
38 |
Section 3.07. |
Optional Redemption |
38 |
Section 3.08. |
Mandatory Redemption |
38 |
|
|
|
ARTICLE IV. COVENANTS |
39 |
|
Section 4.01. |
Payment of Notes |
39 |
Section 4.02. |
Maintenance of Office or Agency |
40 |
Section 4.03. |
Compliance Certificate |
40 |
Section 4.04. |
[Reserved.] |
41 |
Section 4.05. |
Stay, Extension and Usury Laws |
41 |
Section 4.06. |
Collateral |
41 |
Section 4.07. |
Corporate Existence |
41 |
Section 4.08. |
Offer to Repurchase upon Change of Control |
42 |
Section 4.09. |
Guarantees |
44 |
i
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 4.10. |
Reports |
44 |
Section 4.11. |
Creation and Perfection of Liens Securing Collateral; Further Assurances |
44 |
Section 4.12. |
Janssen Agreement |
45 |
Section 4.13. |
Indemnification |
45 |
Section 4.14. |
Tax Matters |
47 |
|
|
|
ARTICLE V. SUCCESSORS |
50 |
|
Section 5.01. |
Merger, Consolidation or Sale of Assets |
50 |
Section 5.02. |
Successor Corporation Substituted |
51 |
|
|
|
ARTICLE VI. DEFAULTS AND REMEDIES |
51 |
|
Section 6.01. |
Events of Default |
51 |
Section 6.02. |
Acceleration |
52 |
Section 6.03. |
Other Remedies |
54 |
Section 6.04. |
Waiver of Past Defaults |
54 |
Section 6.05. |
Control by Majority |
54 |
Section 6.06. |
Limitation on Suits |
55 |
Section 6.07. |
Rights of Holders of Notes to Receive Payment |
55 |
Section 6.08. |
Collection Suit by Trustee |
55 |
Section 6.09. |
Trustee May File Proofs of Claim |
56 |
Section 6.10. |
Priorities |
56 |
Section 6.11. |
Undertaking for Costs |
57 |
Section 6.12. |
Restoration of Rights and Remedies |
57 |
Section 6.13. |
Rights and Remedies Cumulative; Limitation on Damages |
57 |
Section 6.14. |
Delay or Omission Not Waiver |
58 |
|
|
|
ARTICLE VII. TRUSTEE |
58 |
|
Section 7.01. |
Duties of Trustee |
58 |
Section 7.02. |
Rights of Trustee |
59 |
Section 7.03. |
Individual Rights of Trustee |
60 |
Section 7.04. |
Trustees Disclaimer |
61 |
Section 7.05. |
Notice of Defaults |
61 |
Section 7.06. |
Reports by Trustee to Holders of the Notes |
61 |
Section 7.07. |
Compensation and Indemnity |
61 |
Section 7.08. |
Replacement of Trustee |
62 |
Section 7.09. |
Successor Trustee by Merger, Etc. |
63 |
Section 7.10. |
Eligibility; Disqualification |
64 |
Section 7.11. |
Preferential Collection of Claims Against Company |
64 |
|
|
|
ARTICLE VIII. LEGAL DEFEASANCE AND COVENANT DEFEASANCE |
65 |
|
Section 8.01. |
Option to Effect Legal Defeasance or Covenant Defeasance |
65 |
Section 8.02. |
Legal Defeasance and Discharge |
65 |
Section 8.03. |
Covenant Defeasance |
65 |
ii
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 8.04. |
Conditions to Legal or Covenant Defeasance |
66 |
Section 8.05. |
Deposited Money and Government Securities to Be Held in Trust; Other Miscellaneous Provisions |
68 |
Section 8.06. |
Repayment to Company |
68 |
Section 8.07. |
Reinstatement |
69 |
|
|
|
ARTICLE IX. AMENDMENT, SUPPLEMENT AND WAIVER |
69 |
|
Section 9.01. |
Without Consent of Holders of Notes |
69 |
Section 9.02. |
With Consent of Holders of Notes |
70 |
Section 9.03. |
Compliance with Trust Indenture Act |
72 |
Section 9.04. |
Revocation and Effect of Consents |
73 |
Section 9.05. |
Notation on or Exchange of Notes |
73 |
Section 9.06. |
Trustee to Sign Amendments, Etc |
73 |
|
|
|
ARTICLE X. NOTE GUARANTEES |
73 |
|
Section 10.01. |
Note Guarantees |
73 |
Section 10.02. |
Execution and Delivery of Note Guarantee |
75 |
Section 10.03. |
Guarantors May Consolidate or Merge on Certain Terms |
75 |
Section 10.04. |
Releases of Note Guarantees |
76 |
Section 10.05. |
Trustee to Include Paying Agent |
76 |
Section 10.06. |
Limits on Note Guarantees |
77 |
Section 10.07. |
Article XIV Not To Prevent Events of Default or Limit Right To Demand Payment |
77 |
Section 10.08. |
Trustee Not Fiduciary for Holders of Senior Indebtedness of Note Guarantors |
77 |
|
|
|
ARTICLE XI. COLLATERAL AND SECURITY |
77 |
|
Section 11.01. |
Collateral Documents |
77 |
Section 11.02. |
Recording and Opinions |
79 |
Section 11.03. |
Release of Collateral |
79 |
Section 11.04. |
Authorization of Actions to Be Taken by the Trustee and the Collateral Agent Under the Collateral Documents |
80 |
Section 11.05. |
Authorization of Receipt of Funds by the Trustee or the Collateral Agent under the Security Agreement |
81 |
Section 11.06. |
Limitation on Duty of Trustee and Collateral Agent in Respect of Collateral |
81 |
Section 11.07. |
Powers Exercisable by Receiver or Trustee |
82 |
Section 11.08. |
Collateral Agent |
82 |
|
|
|
ARTICLE XII. SATISFACTION AND DISCHARGE |
88 |
|
Section 12.01. |
Satisfaction And Discharge Of Indenture |
88 |
Section 12.02. |
Application of Trust Money |
89 |
|
|
|
ARTICLE XIII. MISCELLANEOUS |
89 |
iii
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 13.01. |
Trust Indenture Act Controls |
89 |
Section 13.02. |
Notices |
89 |
Section 13.03. |
Communication by Holders of Notes with Other Holders of Notes |
91 |
Section 13.04. |
Certificate and Opinion As to Conditions Precedent |
91 |
Section 13.05. |
Statements Required in Certificate or Opinion |
92 |
Section 13.06. |
Rules by Trustee and Agents |
92 |
Section 13.07. |
No Personal Liability of Directors, Officers, Employees and Stockholders |
92 |
Section 13.08. |
Governing Law |
93 |
Section 13.09. |
No Adverse Interpretation of Other Agreements |
93 |
Section 13.10. |
Successors |
93 |
Section 13.11. |
Severability |
93 |
Section 13.12. |
Counterpart Originals |
93 |
Section 13.13. |
Table of Contents, Headings, Etc. |
93 |
Section 13.14. |
Further Instruments and Acts |
93 |
Section 13.15. |
Limitation on Agreements |
94 |
|
|
|
ARTICLE XIV. SUBORDINATION |
94 |
|
Section 14.01. |
Subordination. |
94 |
Section 14.02. |
Absolute and Unconditional Obligation; Realizations from Collateral Not Subordinated |
96 |
Section 14.03. |
Article XIV Not To Prevent Events of Default or Limit Right To Accelerate |
98 |
Section 14.04. |
Trustee Not Fiduciary for Holders of Senior Debt of the Issuer |
98 |
Section 14.05. |
Rights of Holders of Senior Debt Not Impaired |
98 |
Section 14.06. |
Modification of Terms of Senior Debt |
98 |
iv
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Exhibit A |
|
FORM OF NOTE |
Exhibit B |
|
FORM OF CERTIFICATE OF TRANSFER |
Exhibit C |
|
FORM OF CERTIFICATE OF EXCHANGE |
Exhibit D |
|
FORM OF CERTIFICATE OF ACQUIRING INSTITUTIONAL ACCREDITED INVESTOR |
Exhibit E |
|
FORM OF NOTE GUARANTEE |
Exhibit F |
|
FORM OF SUPPLEMENTAL INDENTURE |
Exhibit G |
|
FORM OF SECURITY AGREEMENT |
v
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
CROSS-REFERENCE TABLE
Reconciliation and tie between the Trust Indenture Act of 1939, as amended, and the Indenture, dated as of September 30, 2009.
TRUST INDENTURE |
|
INDENTURE |
|
ACT SECTION |
|
SECTION |
|
§310(a)(l) |
|
7.10 |
|
(a)(2) |
|
7.10 |
|
(a)(3) |
|
N.A. |
|
(a)(4) |
|
N.A. |
|
(a)(5) |
|
7.10 |
|
(b) |
|
7.03; 7.08; 7.10 |
|
(c) |
|
N.A. |
|
§311(a) |
|
7.11 |
|
(b) |
|
7.11 |
|
(c) |
|
N.A. |
|
§312(a) |
|
2.05 |
|
(b) |
|
13.03 |
|
(c) |
|
13.03 |
|
§313(a) |
|
7.06 |
|
(b) |
|
7.06 |
|
(c) |
|
7.06 |
|
(d) |
|
7.06 |
|
§314(a) |
|
4.04; 4.11 |
|
(b) |
|
11.02 |
|
(c)(1) |
|
13.04 |
|
(c)(2) |
|
13.04 |
|
(c)(3) |
|
11.03 |
|
(d) |
|
11.03 |
|
(e) |
|
13.05 |
|
(f) |
|
13.14 |
|
§315(a) |
|
7.01 (b) |
|
(b) |
|
7.05 |
|
(c) |
|
7.01 (a) |
|
(d) |
|
7.01 (c) |
|
(e) |
|
6.11 |
|
§316(a) |
|
2.08 |
|
(a)(1)(A) |
|
6.05 |
|
(a)(1)(B) |
|
6.04 |
|
(a)(2) |
|
N.A. |
|
vi
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
(b) |
|
6.07 |
|
(c) |
|
N.A. |
|
§317(a)(1) |
|
6.08 |
|
(a)(2) |
|
6.09 |
|
(b) |
|
2.04 |
|
§318(a) |
|
13.01 |
|
Note: This reconciliation and tie shall not, for any purpose, be deemed to be a part of the Indenture.
vii
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
INDENTURE
THIS INDENTURE is dated as of September 30, 2009 (this Indenture), by and among VERTEX PHARMACEUTICALS INCORPORATED, a Massachusetts corporation (the Company), the corporations and other entities, if any, from time to time parties hereto as Guarantors (each, a Guarantor and collectively, the Guarantors, as more fully defined below) and U.S. BANK NATIONAL ASSOCIATION, as trustee (the Trustee) and as collateral agent (the Collateral Agent).
RECITALS
The Company has duly authorized the creation and issue of its Secured Notes due 2012 (the Notes) of substantially the tenor and amount hereinafter set forth, and to provide therefor, the Company has duly authorized the execution and delivery of this Indenture.
All things necessary to make the Notes, when executed by the Company and authenticated and delivered by the Trustee hereunder and duly issued by the Company, the valid obligations of the Company and this Indenture a valid instrument of the Company, in accordance with their respective terms, have been done.
NOW, THEREFORE, THIS INDENTURE WITNESSETH, that, for and in consideration of the premises and the purchase of the Notes by the Holders thereof, it is mutually covenanted and agreed, for the equal and proportionate benefit of all Holders of the Notes, as follows:
Section 1.01. Definitions.
144A Global Note means a global note substantially in the form of Exhibit A hereto bearing the Global Note Legend and the Private Placement Legend and deposited with or on behalf of, and registered in the name of, the Depositary or its nominee that will be issued in a denomination equal to the outstanding principal amount at maturity of the Notes sold in reliance on Rule 144A.
Accreted Value means an amount per $1,000 principal amount at maturity of the Notes that is equal to (a) as of any date prior to October 31, 2012, $788.49 accreted at the daily compounding rate equivalent to 8% per year from the Issue Date through the date of determination, computed on the basis of a 365-day year, and (b) as of October 31, 2012, or any date thereafter, $1,000.
1
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Affiliate of any specified Person shall mean any Person that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another Person. For purposes of this definition, control (or its derivatives) shall mean the possession, direct or indirect, of the power or ability to direct or cause the direction of the management and policies of a Person, whether through ownership of equity, voting securities or beneficial interest, by contract or otherwise.
Agent means any Registrar, Paying Agent or co-registrar.
Applicable Procedures means, with respect to any transfer or exchange of or for beneficial interests in any Global Note, the rules and procedures of the Depositary, Euroclear and Clearstream that apply to such transfer or exchange.
Authentication Order has the meaning set forth in Section 2.02 hereof
Bankruptcy Law means Title 11, U.S. Code or any similar federal or state law for the relief of debtors as now or hereinafter constituted.
Board of Directors means (1) with respect to a corporation, the board of directors of the corporation, (2) with respect to a partnership, the Board of Directors of the general partner of the partnership or, if the partnership has more than one general partner, the managing general partner of the partnership and (3) with respect to any other Person, the board or committee of such Person serving a similar function.
Board Resolution means a resolution certified by the Secretary or an Assistant Secretary of the Company to have been duly adopted by the Board of Directors of the Company and to be in full force and effect on the date of such certification.
Business Day means any day other than a Legal Holiday.
Capital Stock means (i) in the case of a corporation, corporate stock, (ii) in the case of an association or other business entity, any and all shares, interests, participations, rights or other equivalents (however designated) of corporate stock, (iii) in the case of a partnership or limited liability company, partnership or membership interests (whether general or limited) and (iv) any other interest or participation that confers on a Person the right to receive a share of the profits and losses of, or distributions of assets of, the issuing Person.
Change of Control means the occurrence of any of the following events from and after the Issue Date:
2
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Change of Control Offer has the meaning set forth in Section 4.08 hereof.
Change of Control Payment has the meaning set forth in Section 4.08 hereof.
Change of Control Payment Date has the meaning set forth in Section 4.08 hereof.
3
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Clearstream means Clearstream, société anonyme Luxembourg (or any successor securities clearing agency).
Code means the Internal Revenue Code of 1986, as amended from time to time, and the regulations promulgated thereunder.
Collateral means, collectively, the assets and property (and rights and interests in assets and property), now owned or hereafter acquired, of any Person, subject to, or intended or required to be subject to, the Liens created by the Collateral Documents.
Collateral Agent means the party named as such above until a successor replaces it in accordance with the applicable provisions of this Indenture and thereafter means the successor serving hereunder.
Collateral Documents means, collectively, the Security Agreement and all other pledges, agreements, financing statements, mortgages or other filings or documents that create or perfect or purport to create or perfect a Lien in any property or assets in favor of the Collateral Agent (for the benefit of the Trustee and the Holders of Notes), as they may be amended, modified, supplemented, restated, amended and restated or replaced from time to time, and any instruments of assignment or other instruments or agreements executed pursuant to the foregoing.
Commission means the United States Securities and Exchange Commission.
Company means Vertex Pharmaceuticals Incorporated, a Massachusetts corporation, its successors and assigns.
Corporate Trust Office of the Trustee shall be at the address of the Trustee specified in Section 13.02 hereof or such other address as to which the Trustee may give notice to the Company.
Covenant Defeasance has the meaning set forth in Section 8.03 hereof.
Custodian means any receiver, trustee, assignee, liquidator, sequester or similar official under any Bankruptcy Law.
Debtor Relief Laws means the Title 11 of the U.S. Code, and all other liquidation, conservatorship, bankruptcy, assignment for the benefit of creditors, moratorium, rearrangement, receivership, insolvency, reorganization, or similar debtor relief laws of the United States or other applicable jurisdictions from time to time in effect and affecting the rights of creditors generally.
4
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Default means any event that is, or with the passage of time or the giving of notice or both would be, an Event of Default.
Definitive Note means a Note registered in the name of the Holder thereof and issued in accordance with Section 2.06 hereof, substantially in the form of the Notes attached hereto as Exhibit A and that does not include the information called for by footnotes 1, 2 and 4 thereof.
Depositary means, with respect to the Notes issuable or issued in whole or in part in global form, the Person specified in Section 2.03 hereof as the Depositary with respect to the Notes, until a successor shall have been appointed and become such pursuant to the applicable provision of this Indenture, and, thereafter, Depositary shall mean or include such successor.
Documents has the meaning set forth in Section 13.15 hereof.
DTC has the meaning set forth in Section 2.03 hereof.
Euroclear means Euroclear Bank, SA/NV as operator of the Euroclear Clearance System (or any successor securities clearing agency).
Event of Default has the meaning set forth in Section 6.01 hereof.
Exchange Act means the Securities Exchange Act of 1934, as amended, or any successor statute.
Existing Notes shall mean Vertexs 4.75% Convertible Senior Subordinated Notes due 2013.
GAAP means generally accepted accounting principles in the United States of America as in effect from time to time, including those set forth in (1) the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants, (2) the statements and pronouncements of the Financial Accounting Standards Board and (3) such other statements by such other entity as approved by a significant segment of the accounting profession.
Global Note means a Note that contains the information called for by footnote 1, the paragraphs referred to in footnote 2 and the additional schedule referred to in footnote 4 to the form of the Note attached hereto as Exhibit A.
Global Note Legend means the legend set forth in Section 2.06(g)(iv), which is required to be placed on all Global Notes issued under this Indenture.
5
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Government Securities means securities that are direct obligations of the United States of America for the timely payment of which its full faith and credit are pledged.
Governmental Authority shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign).
Guarantee means, as to any Person, a guarantee (other than by endorsement of negotiable instruments for collection in the ordinary course of business), direct or indirect, in any manner including, without limitation, by way of a pledge of assets or through letters of credit or reimbursement agreements in respect thereof, of all or any part of any Indebtedness of another Person.
Guarantor means any Subsidiary that executes a Note Guarantee in accordance with the provisions of this Indenture, and its respective successors and assigns until released from its obligations under its Note Guarantee and this Indenture in accordance with the terms of this Indenture. As of the Issue Date, there are no Guarantors.
Holder means a Person in whose name a Note is registered.
IAI Global Note mean the global Note substantially in the form of Exhibit A hereto bearing the Global Note Legend and the Private Placement Legend and deposited with or on behalf of and registered in the name of the Depositary or its nominee that will be issued on the Issue Date or thereafter in a denomination equal to the outstanding principal amount at maturity of the Notes sold to Institutional Accredited Investors.
Indebtedness when used with respect to any Person, and without duplication, means:
6
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Indenture means this Indenture, as amended or supplemented from time to time.
Indirect Participant means a Person who holds a beneficial interest in a Global Note through a Participant.
7
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Institutional Accredited Investor means an institution that is an accredited investor as defined in Rule 501 (a) (1), (2), (3), (7) under the Securities Act, who is not also a QIB.
Issue Date means the date of original issuance of the Notes under this Indenture.
Janssen shall mean Janssen Pharmaceutica, N.V., a Belgium corporation, including its successors and assigns.
Janssen Agreement shall mean the License, Development, Manufacturing and Commercialization Agreement by and between the Company and Janssen effective as of June 30, 2006, as such agreement is amended and in effect on the date hereof, together with the Janssen Consent, except as expressly set forth herein, as each may be amended and/or restated from time to time after the date hereof in accordance with the terms of this Indenture and any new, substitute or amended agreement by and between the Company and Janssen relating to the Milestone Payments to be made after the date hereof in accordance with the terms of this Indenture.
Janssen Consent means all consents and other agreements necessary under the Jansen Agreement for the Company to grant a security interest in favor of the Collateral Agent in accordance with the terms of this Indenture and the Collateral Documents and the consummation of the other transactions contemplated by the Indenture and the Collateral Documents, including any consents required under Section 15.2 of the Janssen Agreement.
Legal Defeasance has the meaning set forth in Section 8.02 hereof.
Legal Holiday means a Saturday, a Sunday or a day on which banking institutions in The City of New York, The Grand Duchy of Luxembourg or at a place of payment are authorized or required by law, regulation or executive order to remain closed.
Lien shall mean any lien, hypothecation, charge, instrument, license, preference, priority, security agreement, security interest, mortgage, option, right of first refusal, privilege, pledge, liability, covenant or order, or any encumbrance, restriction, right or claim of any other Person or Governmental Authority of any kind whatsoever, whether choate or inchoate, filed or unfiled, noticed or unnoticed, recorded or unrecorded, contingent or non-contingent, material or non-material, known or unknown, provided that nothing herein shall prohibit any of the above created solely in favor of the Collateral Agent for the benefit of the Trustee and the Holders by the Collateral Documents.
Liquidated Damages means as of the respective date of determination, a Dollar amount that is equal to (a) as of any date prior to October 31, 2012, an
8
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
amount calculated using the formula 1000 times (1-(1/ert)) where e and r have the meaning given such term in Section 4.14 hereof and t is a number that is equal to 1/365th of the difference between (i) 1,127 and (ii) the total number of days elapsed from the Issue Date to the date of determination and (b) as of October 31, 2012, or any date thereafter, $0.
Maturity Date means October 31, 2012.
[***].
[***].
[***].
[***].
Milestone Payments shall mean collectively [***]; (ii) (a) all additional amounts added to any of the milestone payments described above in clauses (i)(a) and (b) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payments described above in clauses (i)(a) and (b) pursuant to Section 9.10 of the Janssen Agreement and (b) the Holders Pro Rata Portion of all additional amounts added to the milestone payment described above in clause (i)(c) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payment described above in clause (i)(c) pursuant to Section 9.10 of the Janssen Agreement; (iii) all accounts (as defined under the UCC) evidencing the rights to the payments and amounts described in clauses (i) and (ii) above; and (iv) all proceeds (as defined under the UCC) of the foregoing.
Note Custodian means the Trustee, as custodian with respect to the Global Notes, or any successor entity thereto.
Note Guarantee means a Guarantee of the Notes pursuant to Article X hereof, including a notation in the Notes substantially in the form included in Exhibit E, and any supplemental indenture pursuant to which any Person becomes a Guarantor.
Note Purchase Agreement means the note purchase agreement dated as of the date of this Indenture by and between the Company and Olmsted Park S.A., as such agreement may be amended, supplemented, restated, amended and restated, or otherwise modified from time to time.
Note Obligations means (i) all Accreted Value of, interest (including, without limitation, any interest which accrues after the commencement of any proceeding under any Debtor Relief Law with respect to any of the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding), and Liquidated Damages, if any, on any Note, (ii) all fees, expenses, indemnification obligations and other amounts of whatever nature now or hereafter payable by the Company or any
9
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Guarantor (including, without limitation, any amounts which accrue after the commencement of any proceeding under any Debtor Relief Law with respect to the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding) pursuant to this Indenture, the Notes or any Collateral Document, (iii) all expenses of the Trustee or the Collateral Agent (or any agent or sub-agent thereof) under this Indenture as to which the Trustee or the Collateral Agent or one or more of such agents have a right to reimbursement or under any other similar provision of any Collateral Document, including, without limitation, any and all sums advanced by the Trustee or the Collateral Agent to preserve the Collateral or preserve its security interests, mortgages or Liens in the Collateral to the extent permitted under this Indenture, the Notes or any other Collateral Document or applicable law, and (iv) in the case of each Guarantor, all amounts now or hereafter payable by such Guarantor and all other obligations or liabilities now existing or hereafter arising or incurred (including, without limitation, any amounts which accrue after the commencement of any proceeding under any Debtor Relief Law with respect to the Company or such Guarantor, whether or not allowed or allowable as a claim in any such proceeding) on the part of such Guarantor pursuant to the Notes, this Indenture, the Note Guarantees or any other Collateral Document, together in each case with all renewals, modifications, consolidations or extensions thereof.
Obligations means any principal, interest, penalties, fees, expenses, indemnifications, reimbursements, damages and other liabilities payable under the documentation governing any Indebtedness.
Officer means, with respect to any Person, the Chairman of the Board, the Chief Executive Officer, the President, the Chief Operating Officer, the Chief Financial Officer, the Treasurer, any Assistant Treasurer, the Controller, the Secretary, the Assistant Secretary or any Senior Vice-President of such Person.
Officers Certificate means a certificate signed on behalf of the Company by at least two Officers of the Company, one of whom must be the principal executive officer, the principal financial officer, the controller, the treasurer, the assistant treasurer or the principal accounting officer of the Company, that meets the requirements of Section 13.05 hereof.
Opinion of Counsel means an opinion from legal counsel (who may be counsel to, in-house counsel for or an employee of the Company) that meets the requirements of Section 13.05 hereof.
Participant means, with respect to the Depositary, Euroclear or Clearstream, a Person who has an account with the Depositary, Euroclear or Clearstream, respectively (and, with respect to DTC, shall include Euroclear and Clearstream).
Paying Agent has the meaning set forth in Section 2.03 hereof.
10
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Payment Default has the meaning set forth in Section 6.01 hereof.
Payments from Collateral has the meaning set forth in Section 14.02(b).
Person shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization of any kind.
Private Placement Legend means the legend set forth in Section 2.06(g)(iii) to be placed on all Notes issued under this Indenture except where otherwise permitted by the provisions of this Indenture.
Prohibited Amendment shall mean any amendment, modification, restatement or supplement of any provision of the Janssen Agreement that changes in any way (i) the event underlying any of the Milestone Events, (ii) the amount of any of the Milestone Payments or (iii) the timing of the payment of any of the Milestone Payments by Janssen after achievement of the applicable Milestone Event by Janssen. For avoidance of doubt, any termination of the Janssen Agreement shall not be deemed a Prohibited Amendment.
Pro Rata Portion shall mean, with respect to the Holders[***] and, with respect to the Company[***].
Purchase Documents means the Note Purchase Agreement and all related documents.
QIB means a qualified institutional buyer as defined in Rule 144A.
Registrar has the meaning set forth in Section 2.03 hereof.
Regulations S means Regulation S promulgated under the Securities Act.
Regulation S Global Note means a Global Note bearing the Private Placement Legend and deposited with or on behalf of the Depositary and registered in the name of the Depositary or its nominee, issued in a denomination equal to the outstanding principal amount at maturity of the Notes initially sold in reliance on Rule 903 of Regulation S.
Related Parties means, with respect to any Person, such Persons Affiliates and the partners, directors, officers, employees, agents and advisors of such Person and of such Persons Affiliates.
Responsible Officer, when used with respect to the Trustee, means any officer within the Corporate Trust Administration of the Trustee (or any successor group of the Trustee) or any other officer of the Trustee customarily performing functions similar to those performed by any of the above designated officers and also means, with
11
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
respect to a particular corporate trust matter, any other officer or employee to whom such matter is referred because of his knowledge of and familiarity with the particular subject.
Restricted Definitive Note means a Definitive Note bearing the Private Placement Legend.
Restricted Global Note means a Global Note bearing the Private Placement Legend.
Rule 144 means Rule 144 promulgated under the Securities Act.
Rule 144A means Rule 144A promulgated under the Securities Act.
Rule 903 means Rule 903 promulgated under the Securities Act.
Rule 904 means Rule 904 promulgated under the Securities Act.
Section 9.2.2 Notice shall have the meaning set forth in Section 4.12(b).
Securities Act means the Securities Act of 1933, as amended, or any successor statute.
Security Agreement means the security agreement, dated as of the Issue Date, among the Company, the other parties thereto from time to time, and the Collateral Agent, substantially in the form of Exhibit G, as such agreement may be amended, supplemented, restated, amended and restated, or otherwise modified from time to time.
Senior Debt shall mean the principal of, premium, if any, interest (including interest, to the extent allowable, accruing subsequent to the filing of a petition initiating any proceeding under any state, federal or foreign bankruptcy law, whether or not a claim for post-petition interest is allowable as a claim in any such proceeding) and rent payable on or termination payments with respect to or in connection with, and all fees, costs, expenses and other amounts accrued or due on or in connection with, Indebtedness of the Company or any of its Subsidiaries, whether outstanding on the date of this Indenture or thereafter created, incurred, assumed, guaranteed or in effect guaranteed by the Company or any of its Subsidiaries (including all deferrals, renewals, extensions or refundings of, or amendments, modifications or supplements to, the foregoing), except for: (i) the Existing Notes; (ii) Indebtedness that by its terms expressly provides that it shall not be senior in right of payment to the Notes or the Existing Notes or expressly provides that such Indebtedness is equal in right of payment with or junior in right of payment to the Notes or Existing Notes; and (iii) Indebtedness between or among the Company and any of its Subsidiaries.
12
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Significant Subsidiary means any Subsidiary that would constitute a significant subsidiary within the meaning of Article 1 of Regulation S-X of the Securities Act, as in effect on the Issue Date.
Stated Maturity means, with respect to any installment of interest or principal on any series of Indebtedness, the date on which such payment of interest or principal was scheduled to be paid in the original documentation governing such Indebtedness, and shall not include any contingent obligations to repay, redeem or repurchase any such interest or principal prior to the date originally scheduled for the payment thereof.
Subsidiary or Subsidiaries shall mean with respect to any Person (i) any corporation of which the outstanding Capital Stock having at least a majority of votes entitled to be cast in the election of directors (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time be owned, directly or indirectly, by such Person or by another subsidiary of such Person or (ii) any other Person of which at least a majority voting interest (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time owned, directly or indirectly, by such Person or by another subsidiary of such Person.
Surviving Entity has the meaning set forth in Section 5.01 hereof.
TIA means the Trust Indenture Act of 1939 (15 U.S.C.ss.ss.77aaa-77bbbb) as in effect on the date of this Indenture.
Transfer Restricted Securities means securities that bear or are required to bear the legend set forth in Section 2.06(g)(iii) hereof.
Trustee means the party named as such above until a successor replaces it in accordance with the applicable provisions of this Indenture and thereafter means the successor serving hereunder.
UCC shall mean the Uniform Commercial Code as in effect from time to time in the State of New York.
Unrestricted Definitive Note means one or more Definitive Notes that do not bear and are not required to bear the Private Placement Legend.
Unrestricted Global Note means a permanent Global Note substantially in the form of Exhibit A attached hereto that bears the Global Note Legend and that has the Schedule of Increases and Decreases of Interests in the Global Note attached thereto, and that is deposited with or on behalf of and registered in the name of the Depositary, representing a series of Notes that do not bear the Private Placement Legend.
13
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Voting Stock of a Person means all classes of Capital Stock or other interests (including partnership interests) of such Person then outstanding and normally entitled (without regard to the occurrence of any contingency within the control of such person to satisfy) to vote in the election of directors, managers or trustees thereof.
Section 1.02. Incorporation by Reference of Trust Indenture Act.
Whenever this Indenture refers to a provision of the TIA, the provision is incorporated by reference in and made a part of this Indenture.
The following TIA terms used in this Indenture have the following meanings:
indenture securities means the Notes and the Note Guarantees;
indenture security Holder means a Holder of a Note;
indenture trustee or institutional trustee means the Trustee;
obligor on the Notes means the Company and any successor obligor upon the Notes or any Guarantor.
All other terms used in this Indenture that are defined by the TIA, defined by TIA reference to another statute or defined by Commission rule under the TIA have the meanings so assigned to them.
Section 1.03. Rules of Construction.
Unless the context otherwise requires:
Section 2.01. Form and Dating.
The terms and provisions contained in the Notes shall constitute, and are hereby expressly made, a part of this Indenture and the Company, the Guarantors and the Trustee, by their execution and delivery of this Indenture, expressly agree to such terms and provisions and to be bound thereby.
The aggregate principal amount of the Notes that may be authenticated and delivered under this Indenture is $155,000,000 in principal amount at maturity of Notes, except for Notes authenticated and delivered upon registration of transfer of, or in exchange for, or in lieu of, other Notes pursuant to the terms of this Indenture.
Section 2.02. Execution and Authentication.
Two Officers shall sign the Notes for the Company by manual or facsimile signature. If an Officer whose signature is on a Note no longer holds that office at the time a Note is authenticated, the Note shall nevertheless be valid.
A Note shall not be valid until authenticated by the manual signature of the Trustee. The signature shall be conclusive evidence that the Note has been authenticated under this Indenture.
The Trustee shall, upon a written order of the Company signed by two Officers (Authentication Order), authenticate the Notes in an aggregate principal amount at maturity of $155,000,000. The aggregate principal amount of Notes outstanding at any time may not exceed such amount except as provided in Sections 2.07 and 9.05 hereof. The Trustee may appoint an authenticating agent acceptable to the Company to authenticate Notes. An authenticating agent may authenticate Notes whenever the Trustee may do so. Each reference in this Indenture to authentication by the Trustee includes authentication by such agent. An authenticating agent has the same rights as an Agent to deal with the Company or an Affiliate of the Company.
Section 2.03. Registrar and Paying Agent.
The Company shall maintain an office or agency where Notes may be presented for registration of transfer or for exchange (Registrar). The Company appoints the Trustee to, and the Trustee agrees to, maintain an office or agency where Notes may be presented for payment (Paying Agent). The Registrar shall keep a register of the Notes and of their transfer and exchange. The Company may appoint one or more co-registrars. The term Registrar includes any co-registrar and the term Paying Agent includes any additional paying agent. The Company may change any Registrar without notice to any Holder but may only change the Paying Agent or appoint additional Paying Agents with the prior written consent of the Holders of a majority in aggregate principal amount at maturity of Notes outstanding. The Company shall notify the Trustee in writing of the name and address of any Agent not a party to this Indenture. If the Company fails to appoint or maintain another entity as Registrar or Paying Agent, the Trustee shall act as such. The Company or any of its Subsidiaries may act as Paying Agent or Registrar.
16
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
The Company initially appoints the Trustee to act as Depositary with respect to the Global Notes; provided, that upon the request of Holders of at least 25% in aggregate principal amount at maturity of the then outstanding Notes, the Company shall appoint The Depository Trust Company (DTC) to act as Depositary with respect to the Global Notes and shall take all actions required by DTC in connection therewith.
The Company initially appoints the Trustee to act as the Registrar and Paying Agent and to act as Note Custodian with respect to the Global Notes.
Section 2.04. Paying Agent to Hold Money in Trust.
The Company shall require each Paying Agent other than the Trustee to agree in writing that the Paying Agent will hold in trust for the benefit of Holders or the Trustee all money held by the Paying Agent for the payment of Accreted Value, Liquidated Damages, if any, or interest on the Notes, and will notify the Trustee of any default by the Company or any Guarantor in making any such payment. While any such default continues, the Trustee may require a Paying Agent to pay all money held by it to the Trustee. The Company at any time may require a Paying Agent to pay all money held by it to the Trustee. Upon payment over to the Trustee, the Paying Agent (if other than the Company or a Subsidiary) shall have no further liability for the money received from the Company or a Subsidiary. If the Company or a Subsidiary acts as Paying Agent, it shall segregate and hold in a separate trust fund for the benefit of the Holders all money held by it as Paying Agent. Upon any bankruptcy or reorganization proceedings relating to the Company or a Guarantor, the Trustee shall serve as Paying Agent for the Notes.
Section 2.05. Holder Lists.
The Trustee shall preserve in as current a form as is reasonably practicable the most recent list available to it of the names and addresses of all Holders and shall otherwise comply with TIA §312(a). If the Trustee is not the Registrar, the Company shall, or shall cause the Registrar to, furnish to the Trustee at least seven Business Days before each interest payment date, and at such other times as the Trustee may request in writing, a list in such form and as of such date as the Trustee may reasonably require of the names and addresses of the Holders of Notes and the Company and the Guarantors shall otherwise comply with TIA §312(a).
Section 2.06. Transfer and Exchange.
(1) if the holder of such beneficial interest in a Restricted Global Note proposes to exchange such beneficial interest for a beneficial interest in an Unrestricted Global Note, a certificate from such holder in the form of Exhibit C hereto, including the certifications in item (1)(a) thereof; or
(2) if the holder of such beneficial interest in a Restricted Global Note proposes to transfer such beneficial interest to a Person who shall take delivery thereof in the form of a beneficial interest in an Unrestricted Global Note, a certificate from such holder in the form of Exhibit B hereto, including the certifications in item (4) thereof;
and, in each such case set forth in this subparagraph (iv), if the Registrar or the Company so requests or if the Applicable Procedures so require, an opinion of counsel in form reasonably acceptable to the Registrar and the Company to the effect that such exchange or transfer is in compliance with the Securities Act and that the restrictions on transfer contained herein and in the Private Placement Legend are no longer required in order to maintain compliance with the Securities Act.
(v) Euroclear or Clearstream. Through and including the 40th day after the Issue Date, beneficial interests in the Regulation S Global Note may be held only through Euroclear or Clearstream, unless transferred to a person that takes delivery through a Rule 144A Global Note.
If any such transfer is effected at a time when an Unrestricted Global Note has not yet been issued, the Company shall issue and, upon receipt of an Authentication Order in accordance with Section 2.02 hereof, the Trustee shall authenticate one or more Unrestricted Global Notes in an aggregate principal amount equal to the aggregate principal amount at maturity of beneficial interests transferred.
20
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Beneficial interests in an Unrestricted Global Note cannot be exchanged for, or transferred to Persons who take delivery thereof in the form of, a beneficial interest in a Restricted Global Note.
(1) if the holder of such beneficial interest in a Restricted Global Note proposes to exchange such beneficial interest for an Unrestricted Definitive Note, a certificate from such holder in the form of Exhibit C hereto, including the certifications in item (1)(b) thereof; or
(2) if the holder of such beneficial interest in a Restricted Global Note proposes to transfer such beneficial interest to a Person who shall take delivery thereof in the form of an Unrestricted Definitive Note, a certificate from such holder in the form of Exhibit B hereto, including the certifications in item (4) thereof;
and, in each such case set forth in this subparagraph (ii), if the Registrar or the Company so requests or if the Applicable Procedures so require, an opinion of counsel in form reasonably acceptable to the Registrar and the Company to the effect that such exchange or transfer is in compliance with the Securities Act and that the restrictions on transfer contained herein and in the Private Placement Legend are no longer required in order to maintain compliance with the Securities Act.
(1) if the Holder of such Definitive Notes proposes to exchange such Notes for a beneficial interest in the Unrestricted Global Note, a certificate from such Holder in the form of Exhibit C hereto, including the certifications in item (1)(c) thereof; or
(2) if the Holder of such Definitive Notes proposes to transfer such Notes to a Person who shall take delivery
25
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
thereof in the form of a beneficial interest in the Unrestricted Global Note, a certificate from such Holder in the form of Exhibit B hereto, including the certifications in item (4) thereof;
and, in each such case set forth in this subparagraph (ii), if the Registrar or the Company so requests or if the Applicable Procedures so require, an opinion of counsel in form reasonably acceptable to the Registrar and the Company to the effect that such exchange or transfer is in compliance with the Securities Act and that the restrictions on transfer contained herein and in the Private Placement Legend are no longer required in order to maintain compliance with the Securities Act.
Upon satisfaction of the conditions of any of the subparagraphs in this Section 2.06(d)(ii), the Trustee shall cancel the Definitive Notes and increase or cause to be increased the aggregate principal amount of the Unrestricted Global Note.
If any such exchange or transfer from a Definitive Note to a beneficial interest is effected pursuant to subparagraphs (ii) or (iii) above at a time when an Unrestricted Global Note has not yet been issued, the Company shall issue and, upon receipt of an Authentication Order in accordance with Section 2.02 hereof, the Trustee shall authenticate one or more Unrestricted Global Notes in an aggregate principal amount at maturity equal to the principal amount of Definitive Notes so transferred.
(1) if the Holder of such Restricted Definitive Notes proposes to exchange such Notes for an Unrestricted Definitive Note, a certificate from such Holder in the form of Exhibit C hereto, including the certifications in item (1)(d) thereof; or
(2) if the Holder of such Restricted Definitive Notes proposes to transfer such Notes to a Person who shall take delivery thereof in the form of an Unrestricted Definitive Note, a certificate from such Holder in the form of Exhibit B hereto, including the certifications in item (4) thereof;
27
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
and, in each such case set forth in this subparagraph (ii), if the Registrar or the Company so requests, an opinion of counsel in form reasonably acceptable to the Registrar and the Company to the effect that such exchange or transfer is in compliance with the Securities Act and that the restrictions on transfer contained herein and in the Private Placement Legend are no longer required in order to maintain compliance with the Securities Act.
THIS NOTE WAS ISSUED WITH ORIGINAL ISSUE DISCOUNT FOR PURPOSES OF SECTIONS 1272, 1273 AND 1275 OF THE UNITED STATES INTERNAL REVENUE CODE OF 1986, AS AMENDED. THE ISSUE PRICE OF THIS NOTE WAS 78.8494% OF ITS PRINCIPAL AMOUNT; THE TOTAL AMOUNT OF ORIGINAL ISSUE DISCOUNT IS $211.51 PER NOTE WITH A PRINCIPAL AMOUNT OF $1,000; THE ISSUE DATE IS SEPTEMBER 30, 2009; AND THE YIELD TO MATURITY IS 8.00% PER YEAR.
THE SECURITY (OR ITS PREDECESSOR) EVIDENCED HEREBY WAS ORIGINALLY ISSUED IN A TRANSACTION EXEMPT FROM REGISTRATION UNDER SECTION 5 OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT), AND THE SECURITY EVIDENCED HEREBY MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN APPLICABLE EXEMPTION THEREFROM. EACH PURCHASER OF THE SECURITY EVIDENCED HEREBY IS HEREBY NOTIFIED THAT THE SELLER MAY BE RELYING ON THE EXEMPTION FROM THE PROVISIONS OF SECTION 5 OF THE SECURITIES ACT PROVIDED BY RULE 144A THEREUNDER. THE HOLDER OF THE SECURITY EVIDENCED HEREBY AGREES FOR THE BENEFIT OF VERTEX PHARMACEUTICALS INCORPORATED (THE COMPANY) THAT (A) SUCH SECURITY MAY BE RESOLD, PLEDGED OR OTHERWISE TRANSFERRED, ONLY (1)(a) INSIDE THE UNITED STATES TO A PERSON WHO THE SELLER REASONABLY BELIEVES IS A QUALIFIED INSTITUTIONAL BUYER (AS DEFINED IN RULE 144A UNDER THE SECURITIES ACT) PURCHASING FOR ITS OWN ACCOUNT OR FOR THE ACCOUNT OF A QUALIFIED INSTITUTIONAL BUYER IN A TRANSACTION MEETING THE REQUIREMENTS OF RULE 144A UNDER THE SECURITIES ACT, (b) OUTSIDE THE UNITED STATES TO A FOREIGN PERSON IN A TRANSACTION MEETING THE REQUIREMENTS OF RULE 903 OR RULE 904 OF REGULATION S UNDER THE SECURITIES ACT (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS), (c) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT PROVIDED BY RULE 144 THEREUNDER (IF APPLICABLE) (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS) OR (d) IN ACCORDANCE WITH ANOTHER EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS), (2) TO THE COMPANY OR (3) PURSUANT TO AN EFFECTIVE
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REGISTRATION STATEMENT AND, IN EACH CASE, IN ACCORDANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES OR ANY OTHER APPLICABLE JURISDICTION AND (B) THE HOLDER WILL, AND EACH SUBSEQUENT HOLDER IS REQUIRED TO, NOTIFY ANY PURCHASER OF THE SECURITY EVIDENCED HEREBY OF THE RESALE RESTRICTIONS SET FORTH IN CLAUSE (A) ABOVE. NO REPRESENTATION CAN BE MADE AS TO THE AVAILABILITY OF THE EXEMPTION PROVIDED BY RULE 144 FOR RESALE OF THE SECURITY EVIDENCED HEREBY.
THIS GLOBAL NOTE IS HELD BY THE DEPOSITARY (AS DEFINED IN THE INDENTURE GOVERNING THIS NOTE) OR ITS NOMINEE IN CUSTODY FOR THE BENEFIT OF THE BENEFICIAL OWNERS HEREOF, AND IS NOT TRANSFERABLE TO ANY PERSON UNDER ANY CIRCUMSTANCES EXCEPT THAT (I) THE TRUSTEE MAY MAKE SUCH NOTATIONS HEREON AS MAY BE REQUIRED PURSUANT TO SECTION 2.06(h) OF THE INDENTURE, (II) THIS GLOBAL NOTE MAY BE EXCHANGED IN WHOLE BUT NOT IN PART PURSUANT TO SECTION 2.06(a) OF THE INDENTURE, (III) THIS GLOBAL NOTE MAY BE DELIVERED TO THE TRUSTEE FOR CANCELLATION PURSUANT TO SECTION 2.11 OF THE INDENTURE AND (IV) THIS GLOBAL NOTE MAY BE TRANSFERRED TO A SUCCESSOR DEPOSITARY WITH THE PRIOR WRITTEN CONSENT OF THE COMPANY.
Furthermore, if DTC is the Depository of the Global Notes, each Global Note shall bear a legend in substantially the following form:
UNLESS AND UNTIL IT IS EXCHANGED IN WHOLE OR IN PART FOR NOTES IN CERTIFICATED FORM, THIS NOTE MAY NOT BE TRANSFERRED EXCEPT AS A WHOLE BY THE DEPOSITARY TO A NOMINEE OF THE DEPOSITARY, BY A NOMINEE OF THE DEPOSITARY TO THE DEPOSITARY OR ANOTHER NOMINEE OF
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THE DEPOSITARY OR BY THE DEPOSITARY OR ANY SUCH NOMINEE TO A SUCCESSOR DEPOSITARY OR A NOMINEE OF SUCH SUCCESSOR DEPOSITARY. UNLESS THIS CERTIFICATE IS PRESENTED BY AN AUTHORIZED REPRESENTATIVE OF THE DEPOSITORY TRUST COMPANY (55 WATER STREET, NEW YORK, NEW YORK) (DTC), TO THE COMPANY OR ITS AGENT FOR REGISTRATION OF TRANSFER, EXCHANGE OR PAYMENT, AND ANY CERTIFICATE ISSUED IS REGISTERED IN THE NAME OF CEDE & CO. OR SUCH OTHER NAME AS MAY BE REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC (AND ANY PAYMENT IS MADE TO CEDE & CO. OR SUCH OTHER ENTITY AS MAY BE REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC), ANY TRANSFER, PLEDGE OR OTHER USE HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL INASMUCH AS THE REGISTERED OWNER HEREOF, CEDE & CO., HAS AN INTEREST HEREIN.
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.07. Replacement Notes.
If any mutilated Note is surrendered to the Trustee, or the Company and the Trustee receives evidence to its satisfaction of the destruction, loss or theft of any Note, the Company shall issue and the Trustee, upon the written order of the Company signed by two Officers of the Company, shall authenticate a replacement Note if the Trustees requirements are met. If required by the Trustee or the Company, an indemnity bond must be supplied by the Holder that is sufficient in the judgment of the Trustee and the Company to protect the Company, the Trustee, any Agent and any authenticating agent from any loss that any of them may suffer if a Note is replaced. The Company and the Trustee each may charge for their respective expenses in replacing a Note.
Every replacement Note is an additional obligation of the Company and shall be entitled to all of the benefits of this Indenture equally and proportionately with all other Notes duly issued hereunder.
The provisions of this Section are exclusive and shall preclude (to the extent lawful) all other rights and remedies with respect to the replacement or payment of mutilated, destroyed, lost or stolen Notes.
Section 2.08. Outstanding Notes.
The Notes outstanding at any time are all the Notes authenticated by the Trustee except for those cancelled by it, those delivered to it for cancellation, those reductions in the interest in a Global Note effected by the Trustee in accordance with the provisions hereof, and those described in this Section as not outstanding. Except as set forth in Section 2.09 hereof, a Note does not cease to be outstanding because the Company or an Affiliate of the Company holds the Note.
If a Note is replaced pursuant to Section 2.07 hereof, such Note ceases to be outstanding unless the Trustee receives proof satisfactory to it that the replaced Note is held by a bona fide purchaser.
If the principal amount of any Note is considered paid under Section 4.01 hereof, the Note ceases to be outstanding, its Accreted Value will cease to accrete and interest on it ceases to accrue.
If the Paying Agent (other than the Company, a Subsidiary or an Affiliate of any thereof) holds, on a redemption date or maturity date, money sufficient to pay Notes payable on that date, then on and after that date such Notes shall be deemed to be no longer outstanding and shall cease to accrue interest.
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Section 2.09. Treasury Notes.
In determining whether the Holders of the required principal amount of Notes have concurred in any direction, waiver or consent, Notes owned by the Company, any Guarantor or by any Person directly or indirectly controlling or controlled by or under direct or indirect common control with the Company, shall be considered as though not outstanding, except that for the purposes of determining whether the Trustee shall be protected in relying on any such direction, waiver or consent, only Notes that a Trustee knows are so owned shall be so disregarded.
Section 2.10. Temporary Notes.
Until definitive Notes are ready for delivery, the Company may prepare and the Trustee shall authenticate temporary Notes upon a written order of the Company signed by two Officers of the Company. Temporary Notes shall be substantially in the form of definitive Notes but may have variations that the Company considers appropriate for temporary Notes and as shall be reasonably acceptable to the Trustee. Without unreasonable delay, the Company shall prepare and the Trustee shall authenticate definitive Notes in exchange for temporary Notes.
Holders of temporary Notes shall be entitled to all of the benefits of this Indenture.
Section 2.11. Cancellation.
The Company at any time may deliver Notes to the Trustee for cancellation. The Registrar and Paying Agent shall forward to the Trustee any Notes surrendered to them for registration of transfer, exchange or payment. The Trustee (and no one else) shall cancel all Notes surrendered for registration of transfer, exchange, payment, replacement or cancellation and shall destroy cancelled Notes (subject to the record retention requirement of the Exchange Act). Certification of the destruction of all cancelled Notes shall be delivered to the Company. The Company may not issue new Notes to replace Notes that it has paid or that have been delivered to the Trustee for cancellation.
Section 2.12. Defaulted Interest.
If the Company defaults in a payment of Accreted Value, Liquidated Damages, if any, or any other Note Obligation, the Company shall pay the defaulted interest in any lawful manner plus, to the extent lawful, interest payable on the defaulted interest, to the Persons who are Holders on a subsequent special record date, in each case at the rate provided in the Notes and in Section 4.01 hereof. The Company shall notify the Trustee in writing of the amount of defaulted interest proposed to be paid on each Note and the date of the proposed payment. The Company shall fix or cause to be fixed
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each such special record date and payment date; provided, that no such special record date shall be less than 10 days prior to the related payment date for such defaulted interest. At least 15 days before the special record date, the Company (or, upon the written request of the Company, the Trustee in the name and at the expense of the Company) shall mail or cause to be mailed to Holders a notice that states the special record date, the related payment date and the amount of such interest to be paid.
Section 3.01. Notices to Trustee.
If the Company elects to redeem Notes pursuant to the optional redemption provisions of Section 3.07 hereof, the Company shall furnish to the Trustee, at least 5 Business Days (or such shorter period as shall be acceptable to the Trustee) before the applicable redemption date, an Officers Certificate setting forth (i) the clause of this Indenture pursuant to which the redemption shall occur, (ii) the redemption date, (iii) the principal amount at maturity of Notes to be redeemed and (iv) the redemption price, including the Accreted Value and Liquidated Damages components of the redemption price. If the Company is required to redeem Notes pursuant to the mandatory redemption provisions of Section 3.08(b) hereof, the Company shall furnish to the Trustee, at least 2 Business Days before the applicable redemption date (or such shorter period as shall be acceptable to the Trustee), an Officers Certificate setting forth (i) the redemption date, (ii) the principal amount at maturity of Notes to be redeemed and (iii) the redemption price, including the Accreted Value and Liquidated Damages components of the redemption price.
Section 3.02. Selection of Notes to Be Redeemed.
If less than all of the Notes are to be redeemed at any time, the Trustee shall select the Notes for redemption as follows:
(1) in compliance with the requirements of the principal national securities exchange or the Nasdaq Stock Market, as the case may be, on which the Notes are listed; or
(2) if the Notes are not so listed, on a pro rata basis, by lot or by such method as the Trustee shall deem fair and appropriate.
The Trustee shall promptly notify the Company in writing of the Notes selected for redemption. No Notes of $50,000 or less shall be redeemed in part. Notices of redemption shall be electronically delivered or mailed by first class mail at least 2 but
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not more than 5 Business Days before the redemption date to each Holder to be redeemed at its registered address. Notices of redemption may not be conditional.
If any Note is to be redeemed in part only, the notice of redemption that relates to that Note shall state the portion of the principal amount at maturity thereof to be redeemed. A new Note in principal amount at maturity equal to the unredeemed portion of the original Note will be issued in the name of the Holder thereof upon cancellation of the original Note. Notes called for redemption will become due on the date fixed for redemption. On and after the redemption price is paid to the Holder thereof, Accreted Value will cease to accrete and interest will cease to accrue on such Notes or portions of them called for redemption.
Section 3.03. Notice of Redemption.
At least 2 Business Days but not more than 5 Business Days before a redemption date (which redemption date must be on or before the Maturity Date), the Company shall electronically deliver or cause to be electronically delivered or mail or cause to be mailed, by first class mail, a notice of redemption to each Holder whose Notes are to be redeemed at its registered address.
The notice shall identify the Notes to be redeemed and shall state:
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At the Companys request, the Trustee shall give the notice of redemption in the Companys name and at its expense; provided, however, that the Company shall have delivered to the Trustee, at least 5 Business Days prior to the redemption date (unless a shorter period shall be satisfactory to the Trustee), an Officers Certificate requesting that the Trustee give such notice and setting forth the information to be stated in such notice as provided in the preceding paragraph.
Section 3.04. Effect of Notice of Redemption.
Once notice of redemption is mailed in accordance with Section 3.03 hereof, Notes called for redemption become irrevocably due and payable on the redemption date at the redemption price. A notice of redemption may not be conditional.
Section 3.05. Deposit of Redemption Price.
On or prior to the redemption date, the Company shall deposit with the Trustee or with the Paying Agent money sufficient to pay the redemption price of (including any Liquidated Damages) and accrued interest on all Notes to be redeemed on that date. If the Company or a Subsidiary is the Paying Agent, any deposit with the Paying Agent shall not be deemed to be made unless the Company deposits the applicable amount in the separate trust fund established pursuant to Section 2.04. The Trustee or the Paying Agent shall promptly return to the Company any money deposited with the Trustee or the Paying Agent by the Company in excess of the amounts necessary to pay the redemption price of, and accrued interest, if any, on, all Notes to be redeemed.
If the Company complies with the provisions of the preceding paragraph, on and after the redemption date, Accreted Value shall cease to accrete, Liquidated Damages shall be calculated as of the redemption date, and interest shall cease to accrue on the Notes or the portions of Notes called for redemption. If any Note called for redemption shall not be so paid upon surrender for redemption because of the failure of the Company to comply with the preceding paragraph, interest shall be paid on the unpaid Accreted Value and Liquidated Damages, if any, from the redemption date until such Accreted Value and Liquidated Damages, if any, is paid, and to the extent lawful on any interest not paid on such unpaid Accreted Value and Liquidated Damages, if any, in each case at the rate provided in the Notes and in Section 4.01 hereof.
Payments made hereunder shall be made to the Trustee or Paying Agent no later than 11 a.m. on the applicable redemption date.
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Section 3.06. Notes Redeemed in Part.
Upon surrender of a Note that is redeemed in part, the Company shall issue and, upon the Companys written request, the Trustee shall authenticate for the Holder at the expense of the Company a new Note equal in principal amount to the unredeemed portion of the Note surrendered.
Section 3.07. Optional Redemption.
The Company may redeem the Notes at its option, in whole at any time or in part from time to time, upon not less than 2 nor more than 5 Business Days prior notice electronically delivered or mailed by first-class mail to each Holders registered address, at a redemption price equal to 100% of the Accreted Value of the Notes redeemed plus Liquidated Damages, if any, and accrued and unpaid interest, if any, as of the applicable redemption date.
Any redemption pursuant to this Section 3.07 shall be made in accordance with the provisions of Sections 3.01 through 3.06.
Section 3.08. Mandatory Redemption.
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Any redemption pursuant to this Section 3.08 shall be made pursuant to the provisions of Sections 3.01 through 3.06 hereof.
Section 4.01. Payment of Notes.
The Company shall pay or cause to be paid the Accreted Value of, Liquidated Damages, if any, and interest on the Notes, if any, on the dates and in the manner provided in the Notes. Accreted Value, Liquidated Damages, if any, and interest, if any, shall be considered paid on the date due if the Paying Agent, if other than the Company or a Subsidiary thereof, holds as of 11:00 a.m. Eastern Time on the due date money deposited by the Company in immediately available funds and designated for and sufficient to pay all Accreted Value, Liquidated Damages, if any, and interest then due.
The Company shall pay interest (and any Guarantor shall be obligated for the payment of any interest which accrues after the commencement of any proceeding under any Debtor Relief Law with respect to the Company, whether or not allowed or allowable as a claim against the Company in such proceeding) on overdue Accreted Value and Liquidated Damages, if any, at the rate equal to 12% per annum to the extent lawful. The Company shall pay interest (and any Guarantor shall be obligated for the payment of any such interest which accrues after the commencement of any proceeding under any Debtor Relief Law with respect to the Company, whether or not allowed or allowable as a claim against the Company in such proceeding) on overdue installments of interest, if any, (without regard to any applicable grace period) at the same rate to the extent lawful.
All payments under this Indenture and the Notes shall be made in the City and State of New York except as otherwise provided in the Notes or as otherwise agreed by the Company and the recipient of such payment.
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Section 4.02. Maintenance of Office or Agency.
The Company shall maintain in the Borough of Manhattan, The City of New York, an office or agency (which may be an office of the Trustee or an affiliate of the Trustee, Registrar or co-registrar) where Notes may be surrendered for registration of transfer or for exchange and where notices and demands to or upon the Company in respect of the Notes and this Indenture may be served. The Company shall give prompt written notice to the Trustee of the location, and any change in the location, of such office or agency. If at any time the Company shall fail to maintain any such required office or agency or shall fail to furnish the Trustee with the address thereof, such presentations, surrenders, notices and demands may be made or served at the Corporate Trust Office of the Trustee.
The Company also from time to time may designate one or more other offices or agencies where the Notes may be presented or surrendered for any or all such purposes and from time to time may rescind such designations; provided, however, that no such designation or rescission shall in any manner relieve the Company of its obligation to maintain an office or agency in the Borough of Manhattan, The City of New York for such purposes. The Company shall give prompt written notice to the Trustee of any such designation or rescission and of any change in the location of any such other office or agency.
The Company hereby designates the Corporate Trust Office of the Trustee as one such office or agency of the Company in accordance with Section 2.03.
Section 4.03. Compliance Certificate.
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Section 4.04. [Reserved.]
Section 4.05. Stay, Extension and Usury Laws.
The Company and each Guarantor covenants (to the extent that it may lawfully do so) that it shall not at any time insist upon, plead, or in any manner whatsoever claim or take the benefit or advantage of, any stay, extension or usury law wherever enacted, now or at any time hereafter in force, that may affect the covenants or the performance of this Indenture; and the Company and each Guarantor (to the extent that it may lawfully do so) hereby expressly waives all benefit or advantage of any such law, and covenants that it shall not, by resort to any such law, hinder, delay or impede the execution of any power granted herein (or in any Collateral Document) to the Trustee or the Collateral Agent, but shall suffer and permit the execution of every such power as though no such law has been enacted.
Section 4.06. Collateral.
Except as permitted by Section 4.12(d) hereof, the Company shall not, directly or indirectly, sell, transfer, assign, lease, license, sublicense, convey or otherwise directly or indirectly dispose of any of the Collateral or any interest therein, or create, incur, assume or otherwise cause or suffer to exist or become effective any Lien of any kind on or with respect to any of the Collateral or any interest therein, or enter into any agreement to do any of the foregoing , provided, however, that in no event shall the termination of the Janssen Agreement for any reason be a violation or breach of this Section 4.06 or any other term of this Indenture, the Note Purchase Agreement or the Collateral Documents or constitute an Event of Default under this Indenture.
Section 4.07. Corporate Existence.
Subject to Article V hereof, the Company shall do or cause to be done all things necessary to preserve and keep in full force and effect its corporate existence, rights (charter and statutory) and franchises; provided, however, that the Company shall not be required to preserve any such right or franchise if the Company shall determine that the preservation thereof is no longer desirable in the conduct of the business of the Company and that the loss thereof is not adverse in any material respect to the Holders of the Notes.
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Section 4.08. Offer to Repurchase upon Change of Control.
(1) accept for payment all Notes or portions thereof properly tendered pursuant to the Change of Control Offer;
(2) deposit with the Paying Agent an amount equal to the Change of Control Payment in respect of all Notes or portions thereof so tendered; and
(3) deliver or cause to be delivered to the Trustee the Notes so accepted together with an Officers Certificate stating the aggregate principal amount of Notes or portions thereof being purchased by the Company.
The Paying Agent shall promptly (but in any case not later than five days after the Change of Control Payment Date) mail or wire transfer to each Holder so tendered the Change of Control Payment for such Notes, and the Trustee shall promptly authenticate and mail (or cause to be transferred by book entry) to each Holder a new Note equal in principal amount to any unpurchased portion of the Notes surrendered, if any; provided that each such new Note shall be in a principal amount at maturity of $50,000 or an integral multiple of $1,000 in excess thereof. If the Change of Control Payment Date is on or after an interest record date and on or before the related interest payment date, any accrued and unpaid interest shall be paid to the Person in whose name a Note is registered at the close of business on such record date, and Accreted Value will cease to accrete and no additional interest shall be payable to Holders who tender Notes pursuant to the Change of Control Offer. The Company shall, if required under applicable securities laws, publicly announce the results of the Change of Control Offer on or as soon as practicable after the Change of Control Payment Date. The provisions described herein that require the Company to make a Change of Control Offer following a Change of Control shall be applicable regardless of whether any other provisions of this Indenture are applicable.
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Section 4.09. Guarantees.
(a) The Company shall provide to the Trustee, within 30 days following the date that any Person becomes a Subsidiary that Guarantees (or grants Liens to secure) the Existing Notes, a supplemental indenture to this Indenture substantially in the form set forth in Exhibit F hereto and a joinder or accession agreement or agreements related to (and if specified in a Collateral Document, in the form required by) the Collateral Documents, accompanied by an Opinion of Counsel, executed by such new Subsidiary, providing for a full and unconditional guarantee by such new Subsidiary of the Companys obligations under the Notes and this Indenture.
(b) The Company shall not permit any of its Subsidiaries, directly or indirectly, to Guarantee (or grant any Liens to secure) the Existing Notes unless contemporaneously such Subsidiary executes and delivers to the Trustee a supplemental indenture to this Indenture substantially in the form set forth in Exhibit F hereto, accompanied by an Opinion of Counsel, providing for the full and unconditional Guarantee of the payment of the Notes by such Subsidiary.
(c) A Note Guarantee provided pursuant to Section 4.10(a) or (b) shall be subject to release in accordance with the provisions of Section 10.04 of this Indenture.
(d) A Guarantor may not sell or otherwise dispose of all or substantially all of its assets to, or consolidate with or merge with or into (whether or not such Guarantor is the surviving Person), another Person, other than the Company or another Guarantor, except in accordance with the provisions of Section 10.03 of this Indenture.
Section 4.10. Reports.
(a) The Company and the Guarantors have agreed that, for so long as any Notes remain outstanding, they will furnish to the Holders and to prospective investors, upon their request, the information required to be delivered pursuant to Rule 144A(d)(4) under the Securities Act during any period that the Company and/or any Guarantor is an issuer from which such information is required to be available under Rule 144A(d)(4), provided, however, that the obligations of the Company and the Guarantors under this Section 4.10 shall terminate upon the occurrence of a Change of Control.
(b) The Company shall comply with is obligations, if any, under TIA §314(a).
Section 4.11. Creation and Perfection of Liens Securing Collateral; Further Assurances.
The Company shall comply with the requirements of Section 4.02 of the Security Agreement.
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Section 4.12. Janssen Agreement.
Section 4.13. Indemnification.
The Company and each Guarantor shall pay and hereby indemnifies the Trustee, each Holder, the Collateral Agent and each Related Party of any of the foregoing Persons (each such Person being called an Indemnitee) against, and shall hold each Indemnitee harmless from, any and all losses, claims, damages, liabilities and related expenses (including the fees, charges and disbursements of any counsel for any
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Indemnitee if the Company does not assume the defense of the applicable claim), incurred by any Indemnitee or asserted against any Indemnitee by any third party arising out of, in connection with, or as a result of (i) the execution or delivery of this Indenture, the Notes, any Purchase Document, any Collateral Document, any amendments, supplements, amendment and restatements, modifications or waivers of the provisions hereof or thereof, or any agreement or instrument contemplated hereby or thereby, the performance by the parties hereto of their respective obligations hereunder or thereunder or the consummation of the transactions contemplated hereby or thereby, (ii) the use or proposed use of the proceeds of the Notes, (iii) any actual or alleged presence or release of hazardous materials on or from any property owned or operated by the Company, any Guarantor or any of their respective Affiliates, or any environmental liability related in any way to the Company, any Guarantor or any of their respective Affiliates, or (iv) any actual or prospective claim, litigation, investigation (by any Governmental Authority or otherwise) or proceeding relating to any of the foregoing, whether based on contract, tort or any other theory, brought by a third party, in all cases, whether or not caused by or arising, in whole or in part, out of the comparative, contributory or sole negligence of the Indemnitee; provided that (i) such indemnity shall not, as to any Indemnitee, be available to the extent that such losses, claims, damages, liabilities or related expenses are determined by a court of competent jurisdiction by final and nonappealable judgment to have resulted from the gross negligence or willful misconduct of such Indemnitee if the Company or such Note Guarantor has obtained a final and nonappealable judgment in its favor on such claim as determined by a court of competent jurisdiction and (ii) such indemnity shall not be available to any Holder or Related Party thereof or former Holder or Related Party thereof with respect to (a) any tax, including any interest and penalties thereon, (1) required by law, or alleged to be required by law, to be paid by a Holder or former Holder or (2) withheld in accordance with Section 4.14 from any payment to a Holder or former Holder, (b) any failure by the Holder or any Related Party thereof or of a former Holder or any Related Party thereof to comply with applicable law or (c) any claim, litigation, investigation or proceeding relating to the foregoing. The Company shall pay any amount due under this Section 4.13 upon demand by the Trustee or any Holder, provided that such amounts may be escrowed by the Company with a third-party escrow agent if the Company has asserted that such losses, claims, damages, liabilities or related expenses have resulted from the gross negligence or willful misconduct of such Indemnitee and a final and nonaapealable judgment on such claim has not yet been obtained.
The Company and each Guarantor shall pay or reimburse, within ten (10) days of demand, all reasonable out-of-pocket expenses incurred by the Trustee and the Collateral Agent (including the reasonable fees, charges and disbursements of any such Persons counsel), in connection with the enforcement or protection of its rights following an Event of Default (A) in connection with this Indenture, the Notes and the Collateral Documents (whether in any action, suit or litigation, or any bankruptcy, insolvency or other similar proceedings affecting creditors rights generally) or (B) in
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connection with the Note Obligations, including all such out-of-pocket expenses incurred during any workout, restructuring or negotiations in respect of the Note Obligations.
Section 4.14. Tax Matters.
(a) The following terms shall have the meaning ascribed to them in this Section 4.14(a) for purposes of this Section 4.14:
(i) Aggregate Issue Price means $122,216,581.
(ii) Annual Equivalent Accretion Rate means 8%. (i.e., the implied interest rate on the Notes, on an annualized basis).
(iii) Day Basis means 365.
(iv) e means Eulers number, i.e., the base of the natural logarithm (approximated at 2.7182818).
(v) Imputed Principal means (a) if at any Payment Date, the Payment Amount minus the Regular Interest is less than or equal to zero, then zero; or (b) if at any Payment Date, the Payment Amount minus the Regular Interest is greater than zero, then the ratio of (1) the difference between the Payment Amount as of such Payment Date and the Regular Interest as of such Payment Date over (2) the Imputed Principal Factor as of such Payment Date.
(vi) Imputed Principal Factor as of any Payment Date, means 1 plus the ratio of (a) the Remaining Face Value as of such Payment Date minus the Total Accreted Value as of such Payment Date over (b) the Remaining Aggregate Issue Price as of such Payment Date. For the avoidance of doubt, on the first Payment Date (a) the Remaining Face Value referred to in the immediately preceding sentence shall be the Initial Face Value and (b) the Remaining Aggregate Issue Price referred to in the immediately preceding sentence shall be the Aggregate Issue Price.
(vii) Initial Face Value means the face value of the Notes where the Aggregate Issue Price is accreted at the Annual Equivalent Accretion Rate from the Issue Date to the Maturity Date computed on the basis of a 365-day year. The formula shall be: Pert where P is the Aggregate Issue Price.
(viii) Interest Factor means ert.
(ix) Issue Date means September 30, 2009.
(x) Maturity Date means October 31, 2012.
(xi) Payment means any payment on the Notes.
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(xii) Payment Amount means any amount paid on the Notes.
(xiii) Payment Date means the date of any Payment.
(xiv) Pre-payment Interest means on any Payment Date, (a) the Payment Amount as of such Payment Date minus (b) the sum of the Regular Interest as of such Payment Date and the Imputed Principal as of such Payment Date.
(xv) r means ln(1+Annual Equivalent Accretion Rate).
(xvi) Regular Interest as of any Payment Date, means the lesser of (a) the Payment Amount and (b) the Total Accreted Value as of such Payment Date minus the Remaining Aggregate Issue Price as of such Payment Date. For the avoidance of doubt, on the first Payment Date the Remaining Aggregate Issue Price referred to in the immediately preceding sentence shall be the Aggregate Issue Price.
(xvii) Remaining Aggregate Issue Price means (a) immediately after the first Payment Date, the Aggregate Issue Price minus the Imputed Principal calculated as of such first Payment Date; (b) immediately after any subsequent Payment Date, the immediately preceding Remaining Aggregate Issue Price minus the Imputed Principal calculated as of such subsequent Payment Date. For the avoidance of doubt, prior to and including the first Payment Date, the Remaining Aggregate Issue Price shall be equal to the Aggregate Issue Price.
(xviii) Remaining Face Value as of any Payment Date, means (a) immediately after the first Payment Date, the Initial Face Value minus the Payment Amount as of such first Payment Date, and (b) immediately after any subsequent Payment Date, the immediately preceding Remaining Face Value minus the Payment Amount as of such subsequent Payment Date. For the avoidance of doubt, prior to and including the first Payment Date, the Remaining Face Value shall be equal to the Initial Face Value.
(xix) t means the number of days that have elapsed from the Issue Date to the relevant Payment Date divided by the Day Basis.
(xx) Total Accreted Value as of any date, means the value of the Remaining Aggregate Issue Price at such date accreted at the Annual Equivalent Accretion Rate from the Issue Date to such date computed on the basis of a 365-day year. The formula shall be: Pnert where Pn means the Remaining Aggregate Issue Price. For the avoidance of doubt, prior to and on the first Payment Date, the Remaining Aggregate Issue Price in the first two sentences of this clause 4.14(a)(xx) shall be equal to the Aggregate Issue Price.
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(b) Unless there is a change in applicable law or pursuant to an agreement described in sections 7(c) or 7(e) of the Note Purchase Agreement, for all U.S. federal, state and local tax purposes, all parties will treat (i) the Notes as debt of the Company for all tax purposes, (ii) any Imputed Principal as a repayment of principal and (iii) any Regular Interest as portfolio interest within the meaning of Section 871(h) of the Code.
(c) Unless there is a change in applicable law or pursuant to an agreement described in sections 7(c) or 7(e) of the Note Purchase Agreement, the Company, the Paying Agent and each Guarantor will pay all Imputed Principal and Regular Interest Payments on the Notes (including any such Payment made under a Note Guarantee) free of any withholding taxes, provided that, with respect to U.S. federal withholding taxes, each Holder provides to the Company (i) a properly executed IRS Form W-9 or applicable IRS Form W-8, as the case may be, and (ii) to the extent applicable, a certificate claiming the exemption from U.S. federal withholding tax under Section 871(h) or 881(c) of the Code.
(d) Unless there is a change in applicable law or pursuant to an agreement described in sections 7(c) or 7(e) of the Note Purchase Agreement, with respect to payments of amounts that are Pre-Payment Interest:
(i) to a U.S. Holder that submits a properly executed IRS Form W-9 or a non-U.S. Holder that submits a properly executed IRS Form W-8ECI (in either case, either directly or accompanying a properly executed W-8IMY), the Company, the Paying Agent and each Guarantor (including any such amounts paid under a Note Guarantee) will pay such amounts free of any withholding taxes; and
(ii) to any other non-U.S. Holder, the Company, the Paying Agent and each Guarantor (including any such amounts paid under a Note Guarantee) may withhold from such amounts any amounts required to be withheld for U.S. federal income tax purposes (taking into account any lower withholding rates available under a treaty if a properly executed IRS Form W-8BEN claiming treaty benefits is provided).
(e) Unless there is a change in applicable law or pursuant to an agreement described in sections 7(c) or 7(e) of the Note Purchase Agreement, the Company and each Guarantor agree to report consistently with this Section 4.14 for U.S. federal, state and local tax purposes.
(f) Amounts withheld from a payment on a Note by the Company, the Paying Agent or any Guarantor pursuant to this Section shall not affect the treatment of the applicable payment as paid in full for purposes of the applicable Note and this Indenture.
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(g) For purposes of this Section, a change in applicable law includes a change in regulations, a change in judicial interpretation or a change in other controlling legal authority.
Section 5.01. Merger, Consolidation or Sale of Assets.
The Company shall not: (i) consolidate or merge with or into another Person (whether or not the Company is the surviving corporation) or (2) sell, assign, transfer, convey, lease or otherwise dispose of all or substantially all of the properties and assets of the Company, in one or more related transactions, to another Person, unless at the time and after giving effect thereto:
(1) either: (a) the Company is the surviving corporation; or (b) the Person formed by or surviving any such consolidation or merger (if other than the Company) or to which such sale, assignment, transfer, conveyance or other disposition will have been made (the Surviving Entity) assumes all the obligations of the Company under the Notes, this Indenture and the Collateral Documents;
(2) immediately after giving effect to such transaction on a pro forma basis, no Default or Event of Default exists;
(3) each Guarantor, unless such Guarantor is the Person with which the Company has entered into a transaction under this Section 5.01, will have by amendment to its Note Guarantee confirmed that its Note Guarantee will apply to the obligations of the Company or the Surviving Entity in accordance with the Notes and this Indenture;
(5) the Company delivers to the Trustee an Officers Certificate stating that such transaction and such agreement comply with this Section 5.01 and that all conditions precedent provided for herein relating to such transaction have been complied with;
(6) immediately following such transaction, the Collateral will continue to be subject to the Lien in favor of the Collateral Agent for the benefit of the Trustee and the Holders of the Notes and not be subject to any other Liens.
Clauses (2) and (4) of this Section 5.01 will not apply to any merger, consolidation or sale, assignment, transfer, conveyance or other disposition of assets between or among the Company and any of its wholly-owned Subsidiaries.
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Section 5.02. Successor Corporation Substituted.
Upon any consolidation or merger, or any sale, assignment, transfer, conveyance or other disposition of all or substantially all of the assets of the Company or the Company and its Subsidiaries taken as a whole, in accordance with Section 5.01 hereof, the Surviving Entity will succeed to, and be substituted for (so that from and after the date of such consolidation, merger, sale, assignment, transfer, conveyance or other disposition, the provisions of this Indenture referring to the Company shall refer instead to the Surviving Entity and not to the Company), and may exercise every right and power of, the Company under this Indenture with the same effect as if such Surviving Entity had been named as the Company herein. In any such event (other than any transfer by way of lease), the predecessor Company shall be released and discharged from all liabilities and obligations in respect of the Notes and this Indenture and the predecessor Company may be dissolved, wound up or liquidated at any time thereafter.
Section 6.01. Events of Default.
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Section 6.02. Acceleration.
If any Event of Default (other than an Event of Default specified in clause (d) or (e) of Section 6.01 hereof with respect to the Company occurs and is continuing, the Trustee or the Holders of at least 25% in aggregate principal amount at maturity of the then outstanding Notes may declare all the Notes to be due and payable immediately by notice in writing to the Company specifying the Event of Default(s). Upon any such declaration, the Notes shall become due and payable immediately. Notwithstanding the foregoing, if an Event of Default specified in clause (d) or (e) of Section 6.01 hereof occurs with respect to the Company, all outstanding Notes shall become due and payable immediately without further action, notice or declaration on the part of the Trustee or any Holder.
After a declaration of acceleration, but before any exercise of remedies by the Trustee, the Holders of a majority in aggregate principal amount at maturity of Notes outstanding, by written notice to the Company and the Trustee, may rescind and annul such declaration and its consequences if (a) the Company has paid or deposited with the Trustee a sum sufficient to pay (1) all sums paid or advanced by the Trustee under this Indenture and the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel, (2) all overdue interest on all Notes then outstanding, (3) the Accreted Value of, and Liquidated Damages, if any, on any Notes then outstanding which have become due otherwise than by such declaration of acceleration and interest thereon at the rate borne by the Notes and (4) to the extent that payment of such interest is lawful, interest upon overdue interest at the rate borne by the Notes, (b) the rescission would not conflict with any judgment or decree of a court of competent jurisdiction and (c) all Events of Default, other than the non-payment of Accreted Value of, Liquidated Damages, if any, and interest on the Notes which have become due solely by such declaration of acceleration, have been cured or waived as provided in this Indenture. No
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such rescission shall affect any subsequent default or impair any right consequent thereon.
Upon any Note becoming due and payable under this Section 6.02, whether automatically or by declaration, such Note will forthwith mature and the entire unpaid Accreted Value of such Note, plus (1) all accrued and unpaid interest thereon and (2) Liquidated Damages, if any, determined in respect of such Accreted Value, shall all be immediately due and payable, in each and every case without presentment, demand, protest or further notice, all of which are hereby waived. The Company acknowledges, and the parties hereto agree, that each Holder has the right to maintain its investment in the Notes free from repayment by the Company prior to the Maturity Date, which would deprive each Holder of its full bargained for investment, and that each Holders investment decision was based upon its reasonable expectation of maintaining its investment in the Notes without any redemption or other principal payment prior to the Maturity Date. In order to accommodate the request of the Company to allow for optional redemptions prior to the Maturity Date and in order to mitigate risks associated with allowing the Company to receive and retain Milestone Payments prior to the Maturity Date, the Holders have agreed to permit certain optional redemptions and mandatory redemptions under this Indenture. However, in order to compensate the Holders for damages associated with any such redemption prior to the Maturity Date, whether by optional redemption or by mandatory redemption, the Holders have required, as a material and integral part of their investment decision, and the Company has agreed, that the Company must pay Liquidated Damages with respect to the redeemed Notes as well as the Accreted Value of the redeemed Notes. In addition, in order to mitigate risks associated with the occurrence of Events of Default and Changes of Control, the Holders have provided for acceleration of the Note Obligations in connection with Events of Default and mandatory offers to repurchase the Notes following a Change of Control. However, in order to compensate the Holders for damages associated with any payment of principal prior to the Maturity Date arising out of any such acceleration of the Note Obligations or repurchase prior to the Maturity Date, whether by optional acceleration or by mandatory acceleration, the Holders have required, as a material and integral part of their investment decision, and the Company has agreed, that the Company must pay Liquidated Damages as well as the Accreted Value of the Notes. Any such acceleration (whether automatically or by declaration) or acceptance of a Change of Control Offer is necessary to protect the Holders investment in the Notes and does not constitute an election of remedies or a waiver of the right to receive Liquidated Damages. In each such case described in this paragraph, the Liquidated Damages are intended to provide compensation to the Holders for the damages associated with a redemption, repurchase or other payment of principal prior to the Maturity Date and the deprivation of the right to maintain the investment in the Notes free from repayment prior to the Maturity Date. The Company and the Holders agree that the actual amount of damages may be difficult to determine, and that the Liquidated Damages constitute a reasonable determination of such damages. Upon acceleration of the Notes, Accreted Value shall cease to accrete and
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Liquidated Damages will be calculated as of the date of such acceleration, but interest will accrue on the Accreted Value and the Liquidated Damages at the rate provided for overdue Accreted Value and Liquidated Damages on the Notes in Section 1 of the Notes and Section 4.01 hereof until such Accreted Value and Liquidated Damages are paid.
Section 6.03. Other Remedies.
If an Event of Default occurs and is continuing, the Trustee may pursue any available remedy to collect the payment of principal or Accreted Value, Liquidated Damages, if any, and interest on the Notes or to enforce the performance of any provision of the Notes, this Indenture or any Collateral Document.
The Trustee may maintain a proceeding even if it does not possess any of the Notes or does not produce any of them in the proceeding. A delay or omission by the Trustee, the Collateral Agent or any Holder of a Note in exercising any right or remedy accruing upon an Event of Default shall not impair the right or remedy or constitute a waiver of or acquiescence in the Event of Default. All remedies are cumulative to the extent permitted by law.
Section 6.04. Waiver of Past Defaults.
Subject to Section 6.07 and 9.02 hereof, the Holders of a majority in aggregate principal amount at maturity of the Notes then outstanding by notice to the Trustee may on behalf of the Holders of all of the Notes waive any existing Default or Event of Default and its consequences under this Indenture or the Collateral Documents except a continuing Default or Event of Default in the payment of Accreted Value, Liquidated Damages or any interest on, the Notes (including in connection with an offer to purchase); provided, however, that the Holders of a majority in aggregate principal amount of the then outstanding Notes may rescind an acceleration and its consequences, including any related payment default that resulted from such acceleration. Upon any such waiver, such Default shall cease to exist, and any Event of Default arising therefrom shall be deemed to have been cured for every purpose of this Indenture; but no such waiver shall extend to any subsequent or other Default or Event of Default or impair any right consequent thereon.
Section 6.05. Control by Majority.
Holders of a majority in aggregate principal amount at maturity of the then outstanding Notes may direct the time, method and place of conducting any proceeding for exercising any remedy available to the Trustee or exercising any trust or power conferred on it; provided, however, the Trustee may refuse to follow any direction that conflicts with law or this Indenture, that may involve the Trustee in personal liability or that the Trustee determines in good faith may be unduly prejudicial to the rights of Holders of Notes not joining in the giving of such direction and may take any other action
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it deems proper that is not inconsistent with any such direction received from Holders of Notes.
Section 6.06. Limitation on Suits.
Holders of the Notes may not enforce this Indenture or the Notes except as provided herein. A Holder of a Note may not pursue any remedy with respect to this Indenture or the Notes unless:
A Holder of a Note may not use this Indenture to prejudice the rights of another Holder of a Note or to obtain a preference or priority over another Holder of a Note.
Section 6.07. Rights of Holders of Notes to Receive Payment.
Notwithstanding any other provision of this Indenture (including Section 6.06) or any Collateral Document, the right of any Holder of a Note to receive payment of Accreted Value of, Liquidated Damages, if any, or interest on, such Note or to bring suit for the enforcement of any such payment, on or after the respective due dates expressed in the Note (including in connection with an offer to purchase), shall be absolute and unconditional and shall not be impaired or affected without the consent of such Holder, except to the extent that the institution or prosecution thereof or the entry of judgment thereon would, under applicable law, result in the surrender, impairment, waiver or loss of any Lien of a Collateral Document upon any property subject to such Lien.
Section 6.08. Collection Suit by Trustee.
If an Event of Default specified in Section 6.01(a) or (b) occurs and is continuing, the Trustee is authorized to recover judgment in its own name and as trustee
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of an express trust against the Company or any Guarantor for the whole amount of Accreted Value of, Liquidated Damages, if any, and interest remaining unpaid on the Notes and interest on overdue Accreted Value, Liquidated Damages, if any and, to the extent lawful, interest and such further amount as shall be sufficient to cover the costs and expenses of collection, including the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel.
Section 6.09. Trustee May File Proofs of Claim.
The Trustee is authorized to file such proofs of claim and other papers or documents as may be necessary or advisable in order to have the claims of the Trustee (including any claim for the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel) and the Holders of the Notes allowed in any judicial proceedings relative to the Company (or any other obligor upon the Notes), its creditors or its property and shall be entitled and empowered to collect, receive and distribute any money or other property payable or deliverable on any such claims and any custodian in any such judicial proceeding is hereby authorized by each Holder to make such payments to the Trustee, and in the event that the Trustee shall consent to the making of such payments directly to the Holders, to pay to the Trustee any amount due to it for the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel, and any other amounts due the Trustee under Section 7.07 hereof. To the extent that the payment of any such compensation, expenses, disbursements and advances of the Trustee, its agents and counsel, and any other amounts due the Trustee under Section 7.07 hereof out of the estate in any such proceeding, shall be denied for any reason, payment of the same shall be secured by a Lien on, and shall be paid out of, any and all distributions, dividends, money, securities and other properties that the Holders may be entitled to receive in such proceeding whether in liquidation or under any plan of reorganization or arrangement or otherwise. Nothing herein contained shall be deemed to authorize the Trustee to authorize or consent to or accept or adopt on behalf of any Holder any plan of reorganization, arrangement, adjustment or composition affecting the Notes or the rights of any Holder, or to authorize the Trustee to vote in respect of the claim of any Holder in any such proceeding.
Section 6.10. Priorities.
If the Trustee collects any money pursuant to this Article VI, it shall pay out the money in the following order:
FIRST: to the Trustee, its agents and attorneys for amounts due under Section 7.07 hereof, including payment of all compensation, expense and liabilities incurred, and all advances made, by the Trustee and the costs and expenses of collection;
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SECOND: to Holders of Notes for amounts due and unpaid on the Notes for the Accrued Value of, Liquidated Damages, if any, and interest on the Notes, and all other Note Obligations, ratably, without preference or priority of any kind, according to the aggregate of such amounts due and payable; and
THIRD: to the Company or to such party as a court of competent jurisdiction shall direct.
The Trustee may fix a record date and payment date for any payment to Holders of Notes pursuant to this Section 6.10.
Section 6.11. Undertaking for Costs.
In any suit for the enforcement of any right or remedy under this Indenture or in any suit against the Trustee for any action taken or omitted by it as a Trustee, a court in its discretion may require the filing by any party litigant in the suit of an undertaking to pay the costs of the suit, and the court in its discretion may assess reasonable costs, including reasonable attorneys fees, against any party litigant in the suit, having due regard to the merits and good faith of the claims or defenses made by the party litigant. This Section does not apply to a suit by the Trustee, a suit by a Holder of a Note pursuant to Section 6.07 hereof, or a suit by Holders of more than 10% in aggregate principal amount of the then outstanding Notes.
Section 6.12. Restoration of Rights and Remedies.
If the Trustee or any Holder has instituted any proceeding to enforce any right or remedy under this Indenture and such proceeding has been discontinued or abandoned for any reason, or has been determined adversely to the Trustee or to such Holder, then and in every such case the Company, the Trustee and the Holders shall, subject to any determination in such proceeding, be restored severally and respectively to their former positions hereunder, and thereafter all rights and remedies of the Trustee and the Holders shall continue as though no such proceeding had been instituted.
Section 6.13. Rights and Remedies Cumulative; Limitation on Damages.
Except as otherwise provided in Section 2.07 hereof, no right or remedy herein conferred upon or reserved to the Trustee or to the Holders is intended to be exclusive of any other right or remedy, and every right and remedy shall, to the extent permitted by law, be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other appropriate right or remedy. Notwithstanding anything to the contrary in this Indenture, the Note Purchase Agreement or the Collateral Documents, the Company shall not be liable for any indirect, special,
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incidental or consequential damages (included but not limited to lost profits) whatsoever under this Indenture, the Note Purchase Agreement or the Collateral Documents, even if it has been informed of the likelihood thereof and regardless of the form of action; provided, however, that this Section 6.13 shall not apply to or in any way prevent a claim for, or payment of, any Liquidated Damages due hereunder.
Section 6.14. Delay or Omission Not Waiver.
No delay or omission of the Trustee or of any Holder of any Note to exercise any right or remedy accruing upon any Event of Default shall impair any such right or remedy or constitute a waiver of any such Event of Default or an acquiescence therein. Every right and remedy given by this Article VI or by law to the Trustee or to the Holders may be exercised from time to time, and as often as may be deemed expedient, by the Trustee or by the Holders, as the case may be.
Section 7.01. Duties of Trustee.
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Section 7.02. Rights of Trustee.
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Section 7.03. Individual Rights of Trustee.
The Trustee in its individual or any other capacity may become the owner or pledgee of Notes and may otherwise deal with the Company or any Affiliate of the Company with the same rights it would have if it were not Trustee; provided, however, in the event that the Trustee acquires any conflicting interest, the Trustee must (a) eliminate such conflict within 90 days, (b) if a registration statement with respect to the Notes is effective, apply to the Commission for permission to continue as Trustee or (c) resign as Trustee. Any Agent may do the same with like rights and duties. The Trustee is also subject to Sections 7.10 and 7.11 hereof.
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Section 7.04. Trustees Disclaimer.
The Trustee shall not be responsible for and makes no representation as to the validity or adequacy of this Indenture or the Notes, it shall not be accountable for the Companys use of the proceeds from the Notes or any money paid to the Company or upon the Companys direction under any provision of this Indenture, it shall not be responsible for the use or application of any money received by any Paying Agent other than the Trustee, and it shall not be responsible for any statement or recital herein or any statement in the Notes or any other document in connection with the sale of the Notes or pursuant to this Indenture other than its certificate of authentication.
Section 7.05. Notice of Defaults.
If a Default or Event of Default occurs and is continuing and if it is known to the Trustee, the Trustee shall mail to Holders of Notes a notice of the Default or Event of Default within 5 days after it occurs. Except in the case of a Default or Event of Default in payment of Accreted Value of, Liquidated Damages, if any, or interest on any Note, the Trustee may withhold the notice if and so long as a committee of its Responsible Officers in good faith determines that withholding the notice is in the interests of the Holders of the Notes.
Section 7.06. Reports by Trustee to Holders of the Notes.
Within 60 days after May 15 of each year commencing with the year 2010, and for so long as Notes remain outstanding, the Trustee shall mail to the Holders of the Notes a brief report dated as of such reporting date that complies with TIA §313(a) (but if no event described in TIA §313(a) has occurred within the 12 months preceding the reporting date, no report need be transmitted). The Trustee also shall comply with TIA §313(b)(2). The Trustee shall also transmit by mail all reports as required by TIA §313(c).
A copy of each report at the time of its mailing to the Holders of Notes shall be mailed to the Company and filed with the Commission and each stock exchange on which the Notes are listed in accordance with TIA §313(d). The Company shall promptly notify the Trustee when the Notes are listed on any stock exchange.
Section 7.07. Compensation and Indemnity.
The Company shall pay to the Trustee from time to time reasonable compensation for its acceptance of this Indenture and services hereunder. The Trustees compensation shall not be limited by any law on compensation of a trustee of an express trust. The Company shall reimburse the Trustee promptly upon request for all reasonable disbursements, advances and expenses incurred or made by it in addition to the
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compensation for its services. Such expenses shall include the reasonable compensation, disbursements and expenses of the Trustees agents and counsel.
The Company shall indemnify the Trustee against any and all losses, liabilities or expenses incurred by it arising out of or in connection with the acceptance or administration of its duties under this Indenture, including the costs and expenses of enforcing this Indenture against the Company (including this Section 7.07) and defending itself against any claim (other than claims asserted by the Company or any Holder) or liability in connection with the exercise or performance of any of its powers or duties hereunder, except to the extent any such loss, liability or expense may be attributable to its negligence or bad faith. The Trustee shall notify the Company promptly of any claim for which it may seek reasonable indemnity. Failure by the Trustee to so notify the Company shall not relieve the Company of its obligations hereunder (except to the extent such failure prejudices the Company). The Company shall defend the claim and the Trustee shall cooperate in the defense. The Trustee may have separate counsel, and the Company shall pay the reasonable fees and expenses of one such counsel. The Company need not pay for any settlement made without its consent, which consent shall not be unreasonably withheld.
The obligations of the Company under this Section 7.07 shall survive the satisfaction and discharge of this Indenture.
To secure the Companys payment obligations in this Section, the Trustee shall have a Lien prior to the Notes on all money or property held or collected by the Trustee, except that held in trust to pay principal and interest on particular Notes. Such Lien shall survive the satisfaction and discharge of this Indenture.
When the Trustee incurs expenses or renders services after an Event of Default specified in Section 6.01(h) or (i) hereof occurs, the expenses and the compensation for the services (including the fees and expenses of its agents and counsel) are intended to constitute expenses of administration under any Bankruptcy Law.
The Trustee shall comply with the provisions of TIA §313(b)(2) to the extent applicable.
Section 7.08. Replacement of Trustee.
A resignation or removal of the Trustee and appointment of a successor Trustee shall become effective only upon the successor Trustees acceptance of appointment as provided in this Section 7.08.
The Trustee may resign in writing at any time and be discharged from the trust hereby created by so notifying the Company. The Holders of Notes of a majority in aggregate principal amount of the then outstanding Notes may remove the Trustee by so
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notifying the Trustee and the Company in writing. The Company may remove the Trustee if:
If the Trustee resigns or is removed or if a vacancy exists in the office of Trustee for any reason, the Company shall promptly appoint a successor Trustee. Within one year after the successor Trustee takes office, the Holders of a majority in aggregate principal amount of the then outstanding Notes may appoint a successor Trustee to replace the successor Trustee appointed by the Company.
If a successor Trustee does not take office within 90 days after the retiring Trustee resigns or is removed, the retiring Trustee, the Company, or the Holders of Notes of at least 10% in aggregate principal amount of the then outstanding Notes may petition any court of competent jurisdiction for the appointment of a successor Trustee.
If the Trustee, after written request by any Holder of a Note who has been a Holder of a Note for at least six months, fails to comply with Section 7.10, such Holder of a Note may petition any court of competent jurisdiction for the removal of the Trustee and the appointment of a successor Trustee.
A successor Trustee shall deliver a written acceptance of its appointment to the retiring Trustee and to the Company. Thereupon, the resignation or removal of the retiring Trustee shall become effective, and the successor Trustee shall have all the rights, powers and duties of the Trustee under this Indenture. The successor Trustee shall mail a notice of its succession to Holders of the Notes. The retiring Trustee shall promptly transfer all property held by it as Trustee to the successor Trustee; provided, all sums owing to the Trustee hereunder have been paid and subject to the Lien provided for in Section 7.07 hereof. Notwithstanding replacement of the Trustee pursuant to this Section 7.08, the Companys obligations under Section 7.07 hereof shall continue for the benefit of the retiring Trustee.
Section 7.09. Successor Trustee by Merger, Etc.
If the Trustee consolidates, merges or converts into, or transfers all or substantially all of its corporate trust business to, another corporation, the successor corporation without any further act shall be the successor Trustee; provided, that such
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corporation shall be otherwise qualified and eligible under this Article VII and under the TIA, without the execution or filing of any paper or any further act on the part of any of the parties hereto. In case any Notes shall have been authenticated, but not delivered, by the Trustee then in office, any successor by merger, conversion or consolidation to such authenticating Trustee may adopt such authentication and deliver the Notes so authenticated with the same effect as if such successor Trustee had itself authenticated such Notes. In the event that any Notes shall not have been authenticated by such predecessor Trustee, any such successor Trustee may authenticate and deliver such Notes, in either its own name or that of its predecessor Trustee, with the full force and effect which this Indenture provides for the certificate of authentication of the Trustee.
Section 7.10. Eligibility; Disqualification.
There shall at all times be a Trustee and a Collateral Agent hereunder that, in each case, is a corporation organized and doing business under the laws of the United States of America or of any state thereof that is authorized under such laws to exercise corporate trustee power, that is subject to supervision or examination by federal or state authorities and that has a combined capital and surplus (with its affiliates) of at least $100.0 million as set forth in its most recent published annual report of condition.
If such Person publishes reports of condition at least annually, pursuant to law or to the requirements of the aforesaid supervising or examining authority, then for the purposes of this Section 7.10, the combined capital and surplus of such corporation shall be deemed to be its combined capital and surplus as set forth in its most recent report of condition so published. None of the Company or any of its Affiliates shall serve as Trustee or Collateral Agent. If at any time the Trustee shall cease to be eligible to serve as Trustee hereunder pursuant to the provisions of this Section 7.10, it shall resign immediately in the manner and with the effect specified in this Article VII. If at any time the Collateral Agent shall cease to be eligible to serve as Collateral Agent hereunder pursuant to the provisions of this Section 7.10, it shall resign by providing (30) days prior written notice to the Trustee and the Company, such resignation to be effective upon the acceptance of a successor agent to its appointment as Collateral Agent.
This Indenture shall always have a Trustee who satisfies the requirements of TIA §310(a)(1), (2) and (5). The Trustee is subject to TIA §310(b).
Section 7.11. Preferential Collection of Claims Against Company.
The Trustee is subject to TIA §311(a), excluding any creditor relationship listed in TIA §311(b). A Trustee who has resigned or been removed shall be subject to TIA §311(a) to the extent indicated therein.
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Section 8.01. Option to Effect Legal Defeasance or Covenant Defeasance.
The Company may, at the option of its Board of Directors evidenced by a resolution set forth in an Officers Certificate, at any time, elect to have either Section 8.02 or 8.03 hereof be applied to all outstanding Notes upon compliance with the conditions set forth below in this Article VIII.
Section 8.02. Legal Defeasance and Discharge.
Upon the Companys exercise under Section 8.01 hereof of the option applicable to this Section 8.02, the Company shall, subject to the satisfaction of the conditions set forth in Section 8.04 hereof, be deemed to have been discharged from its obligations with respect to all outstanding Notes (and the Guarantors shall be deemed to have been discharged from their Note Guarantees) on the date the conditions set forth below are satisfied (hereinafter, Legal Defeasance). For this purpose, Legal Defeasance means that the Company shall be deemed to have paid and discharged the entire Indebtedness represented by the outstanding Notes, which shall thereafter be deemed to be outstanding only for the purposes of Section 8.05 hereof and the other Sections of this Indenture referred to in (a) and (b) below, and to have satisfied all its other obligations under such Notes and this Indenture, and all Obligations of the Guarantors with respect to their Note Guarantees shall be discharged (and the Trustee, on demand of and at the expense of the Company, shall execute proper instruments acknowledging the same), except for the following provisions which shall survive until otherwise terminated or discharged hereunder: (a) the rights of Holders of outstanding Notes to receive from the trust fund described in Section 8.04 hereof, and as more fully set forth in such Section, payments in respect of the Accreted Value of or interest or Liquidated Damages, if any, on such Notes when such payments are due; (b) the Companys obligations with respect to such Notes under Article II and Section 4.02 hereof; (c) the rights, powers, trusts, duties and immunities of the Trustee hereunder, and the Companys and the Guarantors obligations in connection therewith; and (d) this Article VIII (and applicable provisions of Article III insofar as the Notes are to be defeased through a redemption date). Subject to compliance with this Article VIII, the Company may exercise its option under this Section 8.02 notwithstanding the prior exercise of its option under Section 8.03 hereof.
Section 8.03. Covenant Defeasance.
Upon the Companys exercise under Section 8.01 hereof of the option applicable to this Section 8.03, the Company and the Guarantors shall, subject to the satisfaction of the conditions set forth in Section 8.04 hereof, be released from their
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obligations under the covenants contained in Sections 4.06, 4.08, 4.09, 4.11 and 4.12 hereof with respect to the outstanding Notes on and after the date the conditions set forth below are satisfied (hereinafter, Covenant Defeasance), and the Notes shall thereafter be deemed not outstanding for the purposes of any direction, waiver, consent or declaration or act of Holders (and the consequences of any thereof) in connection with such covenants, but shall continue to be deemed outstanding for all other purposes hereunder (it being understood that such Notes shall not be deemed outstanding for accounting purposes). For this purpose, Covenant Defeasance means that, with respect to the outstanding Notes, the Company may omit to comply with and shall have no liability in respect of any term, condition or limitation set forth in any such covenant, whether directly or indirectly, by reason of any reference elsewhere herein to any such covenant or by reason of any reference in any such covenant to any other provision herein or in any other document and such omission to comply shall not constitute a Default or an Event of Default under Section 6.01 hereof, but, except as specified above, the remainder of this Indenture and such Notes shall be unaffected thereby. In addition, upon the Companys exercise under Section 8.01 hereof of the option applicable to this Section 8.03 hereof, subject to the satisfaction of the conditions set forth in Section 8.04 hereof, Section 6.01(c) hereof shall not constitute an Event of Default. Notwithstanding any Covenant Defeasance hereunder, however, the rights, powers, trusts, duties and immunities of the Trustee, and the Companys and the Guarantors obligations in connection therewith, shall survive until otherwise terminated or discharged hereunder.
Section 8.04. Conditions to Legal or Covenant Defeasance.
The following shall be the conditions to the application of either Section 8.02 or 8.03 hereof to the outstanding Notes:
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Section 8.05. Deposited Money and Government Securities to Be Held in Trust; Other Miscellaneous Provisions.
Subject to Section 8.06 hereof, all money and non-callable Government Securities (including the proceeds thereof) deposited with the Trustee (or other qualifying trustee, collectively for purposes of this Section 8.05, the Trustee) pursuant to Section 8.04 hereof in respect of the outstanding Notes shall be held in trust and applied by the Trustee, in accordance with the provisions of such Notes and this Indenture, to the payment, either directly or through any Paying Agent (including the Company acting as Paying Agent) as the Trustee may determine, to the Holders of such Notes of all sums due and to become due thereon in respect of Accreted Value, Liquidated Damages, if any, and interest, but such money need not be segregated from other funds except to the extent required by law.
The Company shall pay and indemnify the Trustee against any tax, fee or other charge imposed on or assessed against the cash or non-callable Government Securities deposited pursuant to Section 8.04 hereof or the principal and interest received in respect thereof other than any such tax, fee or other charge which by law is for the account of the Holders of the outstanding Notes.
Anything in this Article VIII to the contrary notwithstanding, the Trustee shall deliver or pay to the Company from time to time upon the request of the Company any money or noncallable Government Securities held by it as provided in Section 8.04 hereof which, in the opinion of a nationally recognized firm of independent public accountants expressed in a written certification thereof delivered to the Trustee (which may be the opinion delivered under Section 8.04(a) hereof), are in excess of the amount thereof that would then be required to be deposited to effect an equivalent Legal Defeasance or Covenant Defeasance.
Section 8.06. Repayment to Company.
Any money deposited with the Trustee, the Collateral Agent or any Paying Agent, or then held by the Company, in trust for the payment of the principal or Accreted Value of, Liquidated Damages, if any, or interest on any Note and remaining unclaimed for two years after such principal, and Liquidated Damages, if any, or interest has become due and payable shall be paid to the Company on its request (unless any abandoned property law designates that such amounts be paid to another Person) or, if then held by the Company, shall be discharged from such trust; and the Holder of such Note shall thereafter, as a secured creditor, look only to the Company for payments thereof (unless any abandoned property law designates another Person), and all liability of the Trustee, the Collateral Agent or such Paying Agent with respect to such trust money, and all liability of the Company as trustee thereof, shall thereupon cease; provided, however, that the Trustee, the Collateral Agent or such Paying Agent, before being required to make any such repayment to the Company, may at the expense of the
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Company cause to be published once, in The New York Times and The Wall Street Journal (national edition), notice that such money remains unclaimed and that, after a date specified therein, which shall not be less than 30 days from the date of such notification or publication, any unclaimed balance of such money then remaining will be repaid to the Company.
Section 8.07. Reinstatement.
If the Trustee or Paying Agent is unable to apply any United States dollars or non-callable Government Securities in accordance with Section 8.02 or 8.03 hereof, as the case may be, by reason of any order or judgment of any court or governmental authority enjoining, restraining or otherwise prohibiting such application, then the Companys obligations under this Indenture and the Notes shall be revived and reinstated as though no deposit had occurred pursuant to Section 8.02 or 8.03 hereof until such time as the Trustee or Paying Agent is permitted to apply all such money in accordance with Section 8.02 or 8.03 hereof, as the case may be; provided, however, that, if the Company makes any payment of Accreted Vaue of, Liquidated Damages, if any, or interest on any Note following the reinstatement of its obligations, the Company shall be subrogated to the rights of the Holders of such Notes to receive such payment from the money held by the Trustee or Paying Agent.
Section 9.01. Without Consent of Holders of Notes.
Notwithstanding Section 9.02 of this Indenture, the Company, the Guarantors and the Trustee may amend or supplement this Indenture, the Notes, the Note Guarantees or any of the Collateral Documents without the consent of any Holder of a Note:
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Upon the request of the Company and the Guarantors accompanied by a resolution of their respective Boards of Directors authorizing the execution of any such amended or supplemental Indenture, and upon receipt by the Trustee of the documents described in Section 7.02 hereof, the Trustee shall join with the Company and the Guarantors in the execution of any amended or supplemental Indenture authorized or permitted by the terms of this Indenture and to make any further appropriate agreements and stipulations that may be therein contained, but the Trustee shall not be obligated to enter into such amended or supplemental Indenture that affects its own rights, duties or immunities under this Indenture or otherwise.
Section 9.02. With Consent of Holders of Notes.
Except as provided below in this Section 9.02, this Indenture, any of the Collateral Documents, the Notes and the Note Guarantees may be amended or supplemented with the consent of the Holders of at least a majority in aggregate principal amount at maturity of the Notes then outstanding (including, without limitation, consents obtained in connection with a purchase of, or tender offer or exchange offer for, the Notes), and, subject to Sections 6.04 and 6.07 hereof, any existing Default or Event of Default (other than a Default or Event of Default in the payment of the Accreted Value of, Liquidated Damages, if any, or interest on the Notes, except a payment default resulting from an acceleration that has been rescinded) or compliance with any provision of this Indenture or the Notes may be waived with the consent of the Holders of a majority in aggregate principal amount of the then outstanding Notes (including, without
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limitation, consents obtained in connection with a purchase of, or tender offer or exchange offer for, the Notes).
Upon the request of the Company and the Guarantors accompanied by a resolution of their respective Boards of Directors authorizing the execution of any such amended or supplemental Indenture, and upon the filing with the Trustee of evidence satisfactory to the Trustee of the consent of the Holders of Notes as aforesaid, and upon receipt by the Trustee of the documents described in Section 7.02 hereof, the Trustee shall join with the Company and the Guarantors in the execution of such amended or supplemental Indenture unless such amended or supplemental Indenture affects the Trustees own rights, duties or immunities under this Indenture or otherwise, in which case the Trustee may in its discretion, but shall not be obligated to, enter into such amended or supplemental Indenture. It shall not be necessary for the consent of the Holders of Notes under this Section 9.02 to approve the particular form of any proposed amendment or waiver, but it shall be sufficient if such consent approves the substance thereof.
After an amendment, supplement or waiver under this Section becomes effective, the Company shall mail to the Trustee and the Holders of Notes affected thereby a notice briefly describing the amendment, supplement or waiver. Any failure of the Company to mail such notice or any defect therein, shall not, however, in any way impair or affect the validity of any such amended or supplemental Indenture or waiver.
However, without the consent of each Holder affected, an amendment or waiver may not (with respect to any Notes held by a non-consenting Holder):
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Collateral may be released only in accordance with this Indenture (including without limitation Section 11.03). Notwithstanding anything to the contrary in this Article IX, any Guarantor that is a Significant Subsidiary may not be released from any of its obligations under its Note Guarantee or this Indenture (except in accordance with the terms of this Indenture) without the consent of Holders of the Notes representing at least 75% of the aggregate principal amount of the outstanding Notes.
Upon the execution of any supplemental indenture under this Article IX, this Indenture shall be modified in accordance therewith, and such supplemental indenture shall form a part of this Indenture for all purposes; and every Holder theretofore or thereafter authenticated and delivered hereunder shall be bound thereby.
Section 9.03. Compliance with Trust Indenture Act.
Every amendment or supplement to this Indenture, the Note Guarantees or the Notes shall be set forth in an amended or supplemental Indenture that complies with the TIA as then in effect.
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Section 9.04. Revocation and Effect of Consents.
Until an amendment, supplement or waiver becomes effective, a consent to it by a Holder of a Note is a continuing consent by the Holder of a Note and every subsequent Holder of a Note or portion of a Note that evidences the same debt as the consenting Holders Note, even if notation of the consent is not made on any Note. However, any such Holder of a Note or subsequent Holder of a Note may revoke the consent as to its Note if the Trustee receives written notice of revocation before the date the waiver, supplement or amendment becomes effective. An amendment, supplement or waiver becomes effective in accordance with its terms and thereafter binds every Holder.
Section 9.05. Notation on or Exchange of Notes.
The Trustee may place an appropriate notation about an amendment, supplement or waiver on any Note thereafter authenticated. The Company in exchange for all Notes may issue and the Trustee shall authenticate new Notes that reflect the amendment, supplement or waiver.
Failure to make the appropriate notation or issue a new Note shall not affect the validity and effect of such amendment, supplement or waiver.
Section 9.06. Trustee to Sign Amendments, Etc.
The Trustee shall sign any amended or supplemental indenture authorized pursuant to this Article IX if the amendment or supplement does not adversely affect the rights, duties, liabilities or immunities of the Trustee. The Company and each Guarantor may not sign an amendment or supplemental Indenture until each of their respective Boards of Directors approves it. In executing any amended or supplemental indenture, the Trustee shall be entitled to receive and (subject to Section 7.01) shall be fully protected in relying upon, an Officers Certificate and an Opinion of Counsel stating that the execution of such amended or supplemental indenture is authorized or permitted by this Indenture.
Section 10.01. Note Guarantees.
Any Guarantor, by executing a Note Guarantee, jointly and severally, fully and unconditionally, guarantees to each Holder of a Note authenticated and delivered by the Trustee and to the Trustee and its successors and assigns, irrespective of the validity and enforceability of this Indenture, the Notes or the obligations of the Company hereunder or thereunder, that: (a) the Accreted Value of, Liquidated Damages, if any and
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interest (including without limitation any interest which accrues under any Debtor Relief Law with respect to the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding) on the Notes will be promptly paid in full when due, whether at maturity, by acceleration, redemption or otherwise, and interest on the overdue principal of and interest (including without limitation any interest which accrues under any Debtor Relief Law with respect to the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding) on the Notes, if any, if lawful, and all other obligations of the Company to the Holders or the Trustee hereunder or thereunder will be promptly paid in full or performed, all in accordance with the terms hereof and thereof; and (b) in case of any extension of time of payment or renewal of any Notes or any of such other obligations, that same will be promptly paid in full when due or performed in accordance with the terms of the extension or renewal, whether at stated maturity, by acceleration or otherwise. Failing payment when due of any amount so guaranteed or any performance so guaranteed for whatever reason, the Guarantors will be jointly and severally obligated to pay the same immediately. The Guarantors hereby agree that their obligations hereunder shall be unconditional, irrespective of the validity, regularity or enforceability of the Notes or this Indenture, the absence of any action to enforce the same, any waiver or consent by any Holder of the Notes with respect to any provisions hereof or thereof, the recovery of any judgment against the Company, any action to enforce the same or any other circumstance which might otherwise constitute a legal or equitable discharge or defense of a guarantor. Each Guarantor hereby waives diligence, presentment, demand of payment, filing of claims with a court in the event of insolvency or bankruptcy of the Company, any right to require a proceeding first against the Company, protest, notice and all demands whatsoever and covenant that this Note Guarantee will not be discharged except by complete performance of the obligations contained in the Notes and this Indenture and as otherwise provided in this Indenture. If any Holder or the Trustee is required by any court or otherwise to return to the Company or Guarantors, or any Custodian, Trustee, liquidator or other similar official acting in relation to either the Company or Guarantors, any amount paid by either to the Trustee or such Holder, this Note Guarantee, to the extent theretofore discharged, shall be reinstated in full force and effect. Each Guarantor agrees that it shall not be entitled to any right of subrogation in relation to the Holders in respect of any obligations guaranteed hereby until payment in full of all obligations guaranteed hereby. Each Guarantor further agrees that, as between the Guarantors, on the one hand, and the Holders and the Trustee, on the other hand, (x) the maturity of the obligations guaranteed hereby may be accelerated as provided in Article VI for the purposes of this Note Guarantee, notwithstanding any stay, injunction or other prohibition preventing such acceleration in respect of the obligations guaranteed hereby, and (y) in the event of any declaration of acceleration of such obligations as provided in Article VI, such obligations (whether or not due and payable) shall forthwith become due and payable by the Guarantors for the purpose of this Note Guarantee. The Guarantors shall have the right to seek contribution from any non-paying Guarantor so long as the exercise of such right does not impair the rights of the Holders under the Guarantee.
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Section 10.02. Execution and Delivery of Note Guarantee.
To evidence its Note Guarantee set forth in Section 10.01, each Guarantor hereby agrees that a notation of such Note Guarantee substantially in the form included in Exhibit E hereto shall be endorsed by an officer of such Guarantor on each Note authenticated and delivered by the Trustee and that this Indenture shall be executed on behalf of such Guarantor by its President or one of its Vice Presidents.
Each Guarantor hereby agrees that its Note Guarantee set forth in Section 10.01, shall remain in full force and effect notwithstanding any failure to endorse on each Note a notation of such Note Guarantee.
If an officer or Officer whose signature is on this Indenture or on the Note Guarantee no longer holds that office at the time the Trustee authenticates the Note on which a Note Guarantee is endorsed, the Subsidiary Guarantee shall be valid nevertheless.
The delivery of any Note by the Trustee, after the authentication thereof hereunder, shall constitute due delivery of the Note Guarantee set forth in this Indenture on behalf of the Guarantors.
Section 10.03. Guarantors May Consolidate or Merge on Certain Terms.
(a) A Guarantor may not sell or otherwise dispose of all or substantially all of its assets to, or consolidate with or merge with or into (whether or not such Guarantor is the surviving Person), another Person, other than the Company or another Guarantor, unless:
(1) immediately after giving effect to that transaction, no Event of Default exists; and
(2) the Person acquiring the property in any such sale or disposition or the Person formed by or surviving any such consolidation or merger (if other than the Guarantor) assumes all the obligations of that Guarantor under this Indenture and its Note Guarantee pursuant to a supplemental indenture satisfactory to the Trustee and under the Collateral Documents pursuant to a joinder or accession agreement or agreements satisfactory to the Collateral Agent.
Section 10.04. Releases of Note Guarantees.
(a) The Note Guarantee of a Guarantor will be released automatically in connection with any sale or other disposition of all of the Capital Stock, or all or substantially all of the assets, of such Guarantor to a Person that is not (either before or after giving effect to such transaction) a Subsidiary of the Company, if the sale of all such Capital Stock, or all or substantially all of the assets, of that Guarantor complies with this Indenture and the Collateral Documents.
(b) If all or substantially all of the assets of any Guarantor or all of the capital stock of any Guarantor are sold or disposed of in compliance with Section 10.04(a), then such Guarantor (in the event of a sale or other disposition of all of the capital stock of such Guarantor) or the corporation acquiring the property (in the event of a sale or other disposition of all or substantially all of the assets of a Guarantor) shall be released and relieved of its obligations under its Note Guarantee. Upon delivery by the Company to the Trustee of an Officers Certificate and an Opinion of Counsel to the effect that such sale or other disposition was made by the Company in accordance with the provisions of this Indenture and the Collateral Documents, the Trustee shall execute any documents reasonably required in order to evidence the release of any Guarantor from its obligations under its Note Guarantee.
(c) Any Guarantor not released from its obligations under its Note Guarantee pursuant to this Section 10.04 shall remain liable for the full amount of principal of and interest on the Notes and for the other obligations of any Guarantor under this Indenture as provided in this Article X.
Section 10.05. Trustee to Include Paying Agent.
In case at any time any Paying Agent other than the Trustee shall have been appointed by the Company and be then acting hereunder, the term Trustee as used in this Article X, shall in such case (unless the context shall otherwise require) be construed
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as extending to and including such Paying Agent within its meaning as fully and for all intents and purposes as if such Paying Agent were named, in this Article X, in place of the Trustee.
Section 10.06. Limits on Note Guarantees.
Notwithstanding anything to the contrary in this Article X, the aggregate amount of the Obligations guaranteed under this Indenture by any Guarantor shall be reduced to the extent necessary to prevent the Note Guarantee of such Guarantor from violating or becoming voidable under any law relating to fraudulent conveyance or fraudulent transfer or similar laws affecting the rights of creditors.
Section 10.07. Article XIV Not To Prevent Events of Default or Limit Right To Demand Payment.
The failure of a Guarantor to make a payment pursuant its Note Guarantee by reason of any provision in Article XIV hereof shall not be construed as preventing the occurrence of a default by such Guarantor under its Note Guarantee. Nothing in Article XIV hereof shall have any effect on the right of the Holders or the Trustee to make a demand for payment on a Note Guarantee pursuant to this Article X.
Section 10.08. Trustee Not Fiduciary for Holders of Senior Indebtedness of Note Guarantors.
The Trustee shall not be deemed to owe any fiduciary duty to the holders of Senior Debt of a Guarantor and shall not be liable to any such holders if it shall mistakenly pay over or distribute to Holders or such Guarantor or any other Person, money or assets to which any holders of Senior Debt of such Guarantor shall be entitled by virtue of Article XIV hereof or otherwise.
Section 11.01. Collateral Documents.
The due and punctual payment of the Accreted Value of, Liquidated Damages, if any, on and interest, if any, on, the Notes (including, without limitation, any interest which accrues after the commencement of any proceedings under any Debtor Relief Laws with respect to any of the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding) when and as the same shall be due and payable, whether on an interest payment date, at maturity, by acceleration, repurchase, redemption or otherwise, and interest (including, without limitation, any interest which accrues after the commencement of any proceedings under any Debtor
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Relief Laws with respect to any of the Company or any Guarantor, whether or not allowed or allowable as a claim in any such proceeding) on the overdue Accreted Value of, Liquidated Damages, if any, and interest, on the Notes and any other Note Obligations and performance of all other Obligations of the Company and the Guarantors to the Holders of Notes, the Trustee or the Collateral Agent under this Indenture, the Notes (including, without limitation, the Note Guarantees) or the Collateral Documents according to the terms hereunder or thereunder, are secured as provided in the Security Agreement, which the Company has entered into simultaneously with the execution of this Indenture, and the other Collateral Documents in effect from time to time. Each Holder, by its acceptance thereof, consents and agrees to the terms of the Collateral Documents (including, without limitation, the provisions providing for foreclosure and release of Collateral) as the same may be in effect or may be amended, supplemented or otherwise modified from time to time in accordance with their terms and authorizes and directs the Collateral Agent and/or the Trustee (as the case may be) to enter into the Collateral Documents and to perform their obligations and exercise their rights thereunder in accordance therewith. The Company and the Guarantors will deliver to the Trustee copies of all documents delivered to the Collateral Agent pursuant to the Collateral Documents, and will do or cause to be done all such acts and things as may be necessary or proper, or as may be required by the provisions of the Collateral Documents, to assure and confirm to the Trustee and the Collateral Agent the security interest or other Lien in the Collateral contemplated hereby or by the Collateral Documents, as from time to time constituted, so as to render the same available for the security and benefit of this Indenture and of the Notes secured hereby, according to the intent and purposes herein expressed. The Company and the Guarantors shall comply with the terms and provisions of the Collateral Documents and shall take, upon request of the Trustee or the Collateral Agent, any and all actions reasonably required to cause the Collateral Documents to create and maintain, as security for the Note Obligations of the Company and the Guarantors hereunder, a valid and enforceable perfected Lien in and on all the Collateral, in favor of the Collateral Agent for the benefit of the Trustee and the Holders of Notes, superior to and prior to the rights of all third Persons and subject to no other Liens. The provisions of this Section and Article shall apply only to the security interests and other Liens on the Collateral in favor of the Collateral Agent, and shall not impose or be interpreted as imposing any duty on the Company or any Guarantor to act in a manner that preserves the Collateral (including without limitation Janssens obligation to make the Milestone Payments or the amount of any Milestone Payment or the date on which a Milestone Payment is due) or to refrain from acting in a manner that adversely impacts the Collateral (including without limitation Janssens obligation to make the Milestone Payments or the amount of any Milestone Payment or the date on which a Milestone Payment is due); provided that the foregoing provisions of this sentence shall not limit the Companys obligations under Section 4.15 of this Indenture.
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Section 11.02. Recording and Opinions.
The Company shall comply with the provisions of TIA §314(b) (including, without limitation, the provision of an initial and annual Opinion of Counsel under TIA §314(b)); provided that the Company shall not be required to comply with TIA §314(b)(1) until this Indenture is qualified pursuant to the TIA. Following such qualification, to the extent the Company is required to furnish to the Trustee an Opinion of Counsel pursuant to TIA §314(b)(2), the Company shall furnish such opinion within three months following each anniversary date of such qualification.
Section 11.03. Release of Collateral.
(1) in whole, as to all property subject to such Liens, upon:
(A) payment in full of the Accreted Value of, accrued and unpaid interest and Liquidated Damages, if any, on the Notes; or
(B) satisfaction and discharge of this Indenture as set forth in Article XII hereof; or
(C) Legal Defeasance or Covenant Defeasance of this Indenture as set forth in Article VIII hereof; or
(2) in whole or in part, in accordance with the applicable provisions of the Collateral Documents.
Upon receipt of an Officers Certificate and an Opinion of Counsel certifying that all conditions precedent under this Indenture and the Collateral Documents, if any, to such release have been met and any necessary or proper instruments of termination, satisfaction or release prepared by the Company, the Trustee shall, or shall cause the Collateral Agent to, execute, deliver or acknowledge (at the Companys expense) such instruments or releases to evidence the release of any Collateral permitted to be released pursuant to this Indenture or the Collateral Documents. Neither the Trustee nor the Collateral Agent shall be liable for any such release undertaken in good faith in reliance upon any such Officers Certificate or Opinion of Counsel, and notwithstanding any term hereof or in any Collateral Document to the contrary, the Trustee and Collateral Agent shall not be under any obligation to release any such Lien and security interest, or execute and deliver any such instrument of
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release, satisfaction or termination, unless and until it receives such Officers Certificate and Opinion of Counsel.
(b) To the extent applicable, the Company shall cause TIA §313(b), relating to reports, and TIA §314(d), relating to the release of property or securities or relating to the substitution therefore of any property or securities to be subjected to the Lien created by the Collateral Documents, to be complied with. Any certificate or opinion required by TIA §314(d) may be made by an Officer of the Company except in cases where TIA §314(d) requires that such certificate or opinion be made by an independent Person, which Person shall be an independent engineer, appraiser or other expert reasonably satisfactory to the Trustee. Notwithstanding anything to the contrary in this Section 11.03, the Company shall not be required to comply with all or any portion of TIA §314(d) if it determines, in good faith based on advice of counsel, that under the terms of TIA §314(d) and/or any interpretation or guidance as to the meaning thereof of the Commission and its staff, including no action letters or exemptive orders, all or any portion of TIA §314(d) is inapplicable to released Collateral.
(c) To the extent applicable, the Company shall furnish to the Trustee and the Collateral Agent, prior to each proposed release of Collateral pursuant to the Collateral Documents:
(i) all documents required by TIA §314(d); and
(ii) an Opinion of Counsel to the effect that such accompanying documents constitute all documents required by TIA §314(d).
(d) The release of any Collateral from the terms of the Collateral Documents, or the release, in whole or in part, of the Liens created by the Collateral Documents, will not be deemed to impair the security under this Indenture in contravention of the provisions hereof and of the Collateral Documents if and to the extent that the Collateral is released pursuant to this Indenture and the Collateral Documents. In connection with the release of Collateral, the Trustee shall determine whether it has received all documentation required by TIA §314(d) to permit such release.
Section 11.04. Authorization of Actions to Be Taken by the Trustee and the Collateral Agent Under the Collateral Documents.
(a) Subject to the provisions of the Collateral Documents, the Trustee may (but without any obligation to do so), in its sole discretion and without the consent of the Holders of Notes, direct, on behalf of the Holders of Notes, the Collateral Agent to, take all actions it deems necessary or appropriate in order to:
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(1) enforce any of the terms of the Security Agreement and any other Collateral Document; and
(2) collect and receive any and all amounts payable in respect of the Note Obligations of the Company and the Guarantors hereunder.
(b) Subject to the provisions of the Collateral Documents, the Trustee will have power (but without any obligation) to institute and maintain, or to direct, on behalf of the Holders of the Notes, the Collateral Agent to institute and maintain such suits and proceedings as it may deem expedient to prevent any impairment of the Lien on the Collateral by any acts that may be unlawful or in violation of this Indenture or any of the Collateral Documents, and such suits and proceedings as the Trustee may deem expedient to preserve or protect its interests and the interests of the Holders of Notes in the Lien on the Collateral (including power to institute and maintain suits or proceedings to restrain the enforcement of or compliance with any legislative or other governmental enactment, rule or order that may be unconstitutional or otherwise invalid if the enforcement of, or compliance with, such enactment, rule or order would impair the security interest hereunder or be prejudicial to the interests of the Holders of Notes or of the Trustee).
(c) Unless otherwise provided herein, all instructions to the Trustee are to be made pursuant to the vote of the Holders of a majority in aggregate principal amount of Notes.
Section 11.05. Authorization of Receipt of Funds by the Trustee or the Collateral Agent under the Security Agreement.
Each of the Trustee and the Collateral Agent is authorized to receive any funds for the benefit of the Holders of Notes distributed under any of the Collateral Documents, and the Collateral Agent, in accordance with the terms of the Security Agreement, is and the Trustee is authorized to make further distributions of such funds to the Holders of Notes according to the provisions of this Indenture.
Section 11.06. Limitation on Duty of Trustee and Collateral Agent in Respect of Collateral.
(a) Beyond the exercise of reasonable care in the custody thereof, the Trustee and the Collateral Agent shall have no duty as to any Collateral in their possession or control or in the possession or control of any agent or bailee or any income thereon or as to preservation of rights against prior parties or any other rights pertaining thereto and the Trustee and the Collateral Agent shall not be responsible for filing any financing or continuation statements or recording any documents or instruments in any public office at any time or times or otherwise perfecting or maintaining the perfection of any security interest in the Collateral. The Trustee and the Collateral Agent shall be
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deemed to have exercised reasonable care in the custody of the Collateral in their possession if the Collateral is accorded treatment substantially equal to that which it accords its own property and shall not be liable or responsible for any loss or diminution in the value of any of the Collateral, by reason of the act or omission of any agent or bailee selected by the Trustee or the Collateral Agent in good faith.
(b) The Trustee and the Collateral Agent shall not be responsible for the existence, genuineness or value of any of the Collateral or for the validity, perfection, priority or enforceability of the Liens in any of the Collateral, whether impaired by operation of law or by reason of any action or omission to act on its part hereunder, except to the extent such action or omission constitutes gross negligence, bad faith or willful misconduct on the part of the Trustee or the Collateral Agent, for the validity or sufficiency of the Collateral or any agreement or assignment contained therein, for the validity of the title of the Company or any Guarantor to the Collateral, for insuring the Collateral or for the payment of taxes, charges, assessments or Liens upon the Collateral or otherwise as to the maintenance of the Collateral. The Trustee and the Collateral Agent shall have no duty to ascertain or inquire as to the performance or observance of any of the terms of this Indenture or the Collateral Documents by the Company, the Guarantors or the Collateral Agent (if the Trustee is not the Collateral Agent).
Section 11.07. Powers Exercisable by Receiver or Trustee.
In case the Collateral shall be in the possession of a receiver or trustee, lawfully appointed, the powers conferred in this Article XI upon the Company or a Guarantor with respect to the release, sale or other disposition of such property may be exercised by such receiver or trustee, and an instrument signed by such receiver or trustee shall be deemed the equivalent of any similar instrument of the Company or a Guarantor or of any officer or officers thereof required by the provisions of this Article XI; and if the Trustee shall be in the possession of the Collateral under any provision of this Indenture, then such powers may be exercised by the Trustee.
Section 11.08. Collateral Agent.
(a) The Trustee and each of the Holders by acceptance of the Notes hereby designates and appoints the Collateral Agent as its agent under this Indenture and the Collateral Documents and the Trustee and each of the Holders by acceptance of the Notes hereby irrevocably authorizes the Collateral Agent to take such action on its behalf under the provisions of this Indenture and the Collateral Documents and to exercise such powers and perform such duties as are expressly delegated to the Collateral Agent by the terms of this Indenture and the Collateral Documents, together with such powers as are reasonably incidental thereto. The Collateral Agent agrees to act as such on the express conditions contained in this Section 11.08 and Section 7.10. The provisions of this Section 11.08 are solely for the benefit of the Collateral Agent and none of the Trustee, any of the Holders nor any of the Grantors shall have any rights as a third party
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beneficiary of any of the provisions contained herein other than as expressly provided in this Section 11.08. Notwithstanding any provision to the contrary contained elsewhere in this Indenture and the Collateral Documents, the Collateral Agent shall not have any duties or responsibilities, except those expressly set forth herein and in Section 7.10, nor shall the Collateral Agent have or be deemed to have any fiduciary relationship with the Trustee, any Holder, the Company or any Guarantor, and no implied covenants, functions, responsibilities, duties, obligations or liabilities shall be read into this Indenture and the Collateral Documents or otherwise exist against the Collateral Agent. Without limiting the generality of the foregoing sentence, the use of the term agent in this Indenture with reference to the Collateral Agent is not intended to connote any fiduciary or other implied (or express) obligations arising under agency doctrine of any applicable law. Instead, such term is used merely as a matter of market custom, and is intended to create or reflect only an administrative relationship between independent contracting parties. Except as expressly otherwise provided in this Indenture, the Collateral Agent shall have and may use its sole discretion with respect to exercising or refraining from exercising any discretionary rights or taking or refraining from taking any actions which the Collateral Agent is expressly entitled to take or assert under this Indenture and the Collateral Documents, including the exercise of remedies pursuant to Article VI, and any action so taken or not taken shall be deemed consented to by the Trustee and the Holders.
(b) The Collateral Agent may execute any of its duties under this Indenture or the Collateral Documents by or through agents, employees, attorneys-in-fact or through its Affiliates and shall be entitled to an Officers Certificate or an Opinion of Counsel or both concerning all matters pertaining to such duties. The Collateral Agent shall not be responsible for the negligence or misconduct of any agent, employee, attorney-in-fact or Affiliate that it selects as long as such selection was made without negligence or willful misconduct.
(c) None of the Collateral Agent or any of its Affiliates shall (i) be liable for any action taken or omitted to be taken by any of them under or in connection with this Indenture or the transactions contemplated hereby (except for its own negligence or willful misconduct) or under or in connection with the Collateral Documents or the transactions contemplated thereby (except for its own negligence or willful misconduct), or (ii) be responsible in any manner to any of the Trustee or any Holder for any recital, statement, representation, warranty, covenant or agreement made by the Company or Guarantor, or any officer thereof, contained in this Indenture, or in any certificate, report, statement or other document referred to or provided for in, or received by the Collateral Agent under or in connection with, this Indenture or the Collateral Documents, or the validity, effectiveness, genuineness, enforceability or sufficiency of this Indenture or the Collateral Documents, or for any failure of the Company any Guarantor or any other party to this Indenture or the Collateral Documents to perform its obligations hereunder or thereunder. None of the Collateral Agent or any of its Affiliates shall be under any
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obligation to the Trustee or any Holder to ascertain or to inquire as to the observance or performance of any of the agreements contained in, or conditions of, this Indenture or the Collateral Documents or to inspect the properties, books, or records of the Company, any Guarantor or their respective Affiliates.
(d) The Collateral Agent shall be entitled to rely, and shall be fully protected in relying, upon any writing, resolution, notice, consent, certificate, affidavit, letter, telegram, facsimile, telex, or other document believed by it to be genuine and correct and to have been signed, sent, or made by the proper Person or Persons, and upon advice and statements of legal counsel (including, without limitation, counsel to the Company), independent accountants and other experts and advisors selected by the Collateral Agent. The Collateral Agent shall be fully justified in failing or refusing to take any action under this Indenture or the Collateral Documents unless it shall first receive such advice or concurrence of the Trustee as it deems appropriate and, if it so requests, it shall first be indemnified to its reasonable satisfaction by the Holders against any and all liability and expense which may be incurred by it by reason of taking or continuing to take any such action. The Collateral Agent shall in all cases be fully protected in acting, or in refraining from acting, under this Indenture or the Collateral Documents in accordance with a request or consent of the Trustee and such request and any action taken or failure to act pursuant thereto shall be binding upon all of the Holders.
(e) The Collateral Agent shall not be deemed to have knowledge or notice of the occurrence of any Default or Event of Default, unless the Collateral Agent shall have received written notice from the Trustee, Holders of Notes, the Company or a Guarantor referring to this Indenture, describing such Default or Event of Default and stating that such notice is a notice of default. The Collateral Agent shall take such action with respect to such Default or Event of Default as may be requested by the Trustee in accordance with Article VI (subject to this Section 11.08); provided, however, that unless and until the Collateral Agent has received any such request, the Collateral Agent may (but shall not be obligated to) take such action, or refrain from taking such action, with respect to such Default or Event of Default as it shall deem advisable.
(f) U.S. Bank National Association and its respective Affiliates may make loans to, issue letters of credit for the account of, accept deposits from, acquire equity interests in and generally engage in any kind of banking, trust, financial advisory, underwriting, or other business with the Company, any Guarantor or their respective Affiliates as though it was not the Collateral Agent hereunder and without notice to or consent of the Trustee. The Trustee and the Holders acknowledge that, pursuant to such activities, U.S. Bank National Association or its respective Affiliates may receive information regarding the Company or any Guarantor or any of their Affiliates (including information that may be subject to confidentiality obligations in favor of the Company or any Guarantor or any of their Affiliates) and acknowledge that the Collateral Agent shall
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not be under any obligation to provide such information to the Trustee or the Holders. Nothing herein shall impose or imply any obligation on the part of U.S. Bank National Association to advance funds.
(g) The Collateral Agent may resign at any time upon thirty (30) days prior written notice to the Trustee and the Company, such resignation to be effective upon the acceptance of a successor agent to its appointment as Collateral Agent. If the Collateral Agent resigns under this Indenture, the Trustee, subject to the consent of the Company (which shall not be unreasonably withheld and which shall not be required during a continuing Default or Event of Default), shall appoint a successor collateral agent. If no successor collateral agent is appointed prior to the intended effective date of the resignation of the Collateral Agent (as stated in the notice of resignation), the Collateral Agent may appoint, after consulting with the Trustee, subject to the consent of the Company (which shall not be unreasonably withheld and which shall not be required during a continuing Default or Event of Default), a successor collateral agent. If no successor collateral agent is appointed and consented to by the Company pursuant to the preceding sentence within thirty (30) days after the intended effective date of resignation (as stated in the notice of resignation) the Collateral Agent shall be entitled to petition a court of competent jurisdiction to appoint a successor. Upon the acceptance of its appointment as successor collateral agent hereunder, such successor collateral agent shall succeed to all the rights, powers and duties of the retiring Collateral Agent, and the term Collateral Agent shall mean such successor collateral agent, and the retiring Collateral Agents appointment, powers and duties as the Collateral Agent shall be terminated. After the retiring Collateral Agents resignation hereunder, the provisions of this Section 11.08 (and Section 7.07) shall continue to inure to its benefit and the retiring Collateral Agent shall not by reason of such resignation be deemed to be released from liability as to any actions taken or omitted to be taken by it while it was the Collateral Agent under this Indenture.
(h) The Trustee shall initially act as Collateral Agent and shall be authorized to appoint co-Collateral Agents as necessary in its sole discretion. Except as otherwise explicitly provided herein or in the Collateral Documents, neither the Collateral Agent nor any of its respective officers, directors, employees or agents or other Affiliates shall be liable for failure to demand, collect or realize upon any of the Collateral or for any delay in doing so or shall be under any obligation to sell or otherwise dispose of any Collateral upon the request of any other Person or to take any other action whatsoever with regard to the Collateral or any part thereof. The Collateral Agent shall be accountable only for amounts that it actually receives as a result of the exercise of such powers, and neither the Collateral Agent nor any of its officers, directors, employees or agents shall be responsible for any act or failure to act hereunder, except for its own willful misconduct, gross negligence or bad faith.
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(i) The Trustee, as such and as Collateral Agent, is authorized and directed to (i) enter into the Collateral Documents, (ii) bind the Holders on the terms as set forth in the Collateral Documents and (iii) perform and observe its obligations under the Collateral Documents.
(j) The Trustee agrees that it shall not (and shall not be obliged to), and shall not instruct the Collateral Agent to, unless specifically requested to do so by a majority of the Holders, take or cause to be taken any action to enforce its rights under this Indenture or against the Company or the Guarantors, including the commencement of any legal or equitable proceedings, to foreclose any Lien on, or otherwise enforce any security interest in, any of the Collateral.
If at any time or times the Trustee shall receive (i) by payment, foreclosure, set-off or otherwise, any proceeds of Collateral or any payments with respect to the obligations arising under, or relating to, this Indenture, except for any such proceeds or payments received by the Trustee from the Collateral Agent pursuant to the terms of this Indenture, or (ii) payments from the Collateral Agent in excess of the amount required to be paid to the Trustee pursuant to Article VII, the Trustee shall promptly turn the same over to the Collateral Agent, in kind, and with such endorsements as may be required to negotiate the same to the Collateral Agent.
(k) The Trustee is each Holders agent and the Collateral Agent is the Trustees agent for the purpose of perfecting the Holders security interest in assets which, in accordance with Article 9 of the Uniform Commercial Code can be perfected only by possession or control. Should the Trustee obtain possession of any such Collateral, upon request from the Company, the Trustee shall notify the Collateral Agent thereof, and, promptly upon the Collateral Agents request therefor shall deliver such Collateral to the Collateral Agent or otherwise deal with such Collateral in accordance with the Collateral Agents instructions.
(l) The Collateral Agent shall have no obligation whatsoever to the Trustee or any of the Holders to assure that the Collateral exists or is owned by any Grantor or is cared for, protected, or insured or has been encumbered, or that the Collateral Agents Liens have been properly or sufficiently or lawfully created, perfected, protected, maintained or enforced or are entitled to any particular priority, or to determine whether all or any part of the Grantors property constituting collateral intended to be subject to the Lien and security interest of the Collateral Documents has been properly and completely listed or delivered, as the case may be, or the genuineness, validity, marketability or sufficiency thereof or title thereto, or to exercise at all or in any particular manner or under any duty of care, disclosure, or fidelity, or to continue exercising, any of the rights, authorities, and powers granted or available to the Collateral Agent pursuant to this Indenture or any Collateral Document, it being understood and agreed that in respect of the Collateral, or any act, omission, or event related thereto, the
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Collateral Agent may act in any manner it may deem appropriate, in its sole discretion given the Collateral Agents own interest in the Collateral and that the Collateral Agent shall have no other duty or liability whatsoever to the Trustee or any Holder as to any of the foregoing.
(m) No provision of this Indenture or any Collateral Document shall require the Collateral Agent (or the Trustee) to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or thereunder or to take or omit to take any action hereunder or thereunder or take any action at the request or direction of Holders (or the Trustee in the case of the Collateral Agent) if it shall have reasonable grounds for believing that repayment of such funds is not assured to it.
(n) The Collateral Agent (i) shall not be liable for any action it takes or omits to take in good faith which it reasonably believes to be authorized or within its rights or powers, or for any error of judgment made in good faith by a an officer thereof, unless it is proved that the Collateral Agent was negligent in ascertaining the pertinent facts, (ii) shall not be liable for interest on any money received by it except as the Collateral Agent may agree in writing with the Company or any Guarantor (and money held in trust by the Collateral Agent need not be segregated from other funds except to the extent required by law) and (iii) may consult with counsel of its selection and the advice or opinion of such counsel as to matters of law shall be full and complete authorization and protection from liability in respect of any action taken, omitted or suffered by it in good faith and in accordance with the advice or opinion of such counsel. The grant of permissive rights or powers to the Collateral Agent shall not be construed to impose duties to act. The Collateral Agent shall be indemnified by the Company and the Guarantors to the same extent as the indemnification of the Trustee herein.
(o) Neither the Collateral Agent nor the Trustee shall be liable for delays or failures in performance resulting from acts beyond its control. Such acts shall include but not be limited to acts of God, strikes, lockouts, riots, acts of war, epidemics, governmental regulations superimposed after the fact, fire, communication line failures, computer viruses, power failures, earthquakes or other disasters. Neither the Collateral Agent nor the Trustee shall be liable for any indirect, special, incidental or consequential damages (included but not limited to lost profits) whatsoever, even if it has been informed of the likelihood thereof and regardless of the form of action.
(p) The Collateral Agent shall be under no obligation to exercise any of its rights and powers under this Indenture at the request of any Holder, unless such Holder shall have offered to the Collateral Agent security and indemnity satisfactory to it against any loss, liability or expense.
(q) Notwithstanding anything herein to the contrary, in acting as Collateral Agent, the Collateral Agent may rely upon and enforce each and all of the
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rights, powers, immunities, indemnities and benefits of the Trustee under Article VII hereof.
Section 12.01. Satisfaction And Discharge Of Indenture.
This Indenture will be discharged and will cease to be of further effect as to all outstanding Notes hereunder, and the Trustee, upon receipt from the Company of an Officers Certificate and an Opinion of Counsel stating that all conditions precedent to satisfaction and discharge have been satisfied, shall execute proper instruments acknowledging satisfaction and discharge of this Indenture, when either
(1) all Notes that have been authenticated (except lost, stolen or destroyed Notes that have been replaced or paid and Notes for whose payment money has theretofore been deposited in trust and thereafter repaid to the Company) have been delivered to the Trustee for cancellation; or
(2) (A) all Notes that have not been delivered to the Trustee for cancellation have become due and payable by reason of the mailing of a notice of redemption or otherwise or will become due and payable within one year and the Company or any Guarantor has irrevocably deposited or caused to be deposited with the Trustee as trust funds in trust solely for the benefit of the Holders, cash in U.S. dollars, non-callable Government Securities, or a combination thereof, in such amounts as will be sufficient without consideration of any reinvestment of interest, to pay and discharge the entire indebtedness on the Notes not delivered to the Trustee for cancellation for Accreted Value, Liquidated Damages if any, and accrued interest to the date of maturity or redemption;
Notwithstanding the satisfaction and discharge hereof, the rights, powers, trusts, duties and immunities of the Trustee, and the Companys and the Guarantors obligations in connection therewith, the obligations of the Company to the Trustee under Section 7.07 and, if United States dollars shall have been deposited with the Trustee pursuant to subclause (2) of subsection (a) of this Section 12.01, the obligations of the Trustee under Section 12.02 and Section 8.06, shall survive.
Section 12.02. Application of Trust Money.
Subject to the provisions of Section 8.06, all United States dollars deposited with the Trustee pursuant to Section 12.01 shall be held in trust and applied by it, in accordance with the provisions of the Notes and this Indenture, to the payment, either directly or through any Paying Agent (including the Company acting as its own Paying Agent) as the Trustee may determine, to the Persons entitled thereto, of the Accreted Value of, Liquidated Damages, if any, and interest on, the Notes for whose payment such United States dollars have been deposited with the Trustee.
Section 13.01. Trust Indenture Act Controls.
If any provision of this Indenture limits, qualifies or conflicts with the duties imposed by TIA §318(c), the imposed duties shall control. If any provision of this Indenture modifies or excludes any provision of the TIA that may be so modified or excluded, the latter provision shall be deemed to apply to this Indenture as so modified or to be excluded, as the case may be.
Section 13.02. Notices.
Any notice or communication by the Company, a Guarantor or the Trustee to the others is duly given if in writing and delivered in person or mailed by first class mail (registered or certified, return receipt requested), telex, telecopier or overnight air courier guaranteeing next day delivery, to the others address:
If to the Company or a Guarantor:
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Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Philippe Tinmouth
Head, Business Development &
Licensing
Facsimile: 617-444-6632
Email: phil_tinmouth@vrtx.com
with a copy (which shall not constitute notice) to:
Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Kenneth S. Boger, Esq.
Senior Vice President and General
Counsel
Facsimile: 617-444-7117
Email: ken_boger@vrtx.com
If to the Trustee:
U.S. Bank National Association
c/o U.S. Bank Corporate Trust Services
100 Wall Street
Suite 1600
New York, NY 10005
Facsimile: 617-603-6667
Attention: Karen R. Beard
Email: karen.beard@usbank.com
The Company, a Guarantor or the Trustee, by notice to the others may designate additional or different addresses for subsequent notices or communications.
All notices and communications (other than those sent to Holders) shall be deemed to have been duly given: at the time delivered by hand, if personally delivered; five Business Days after being deposited in the mail, postage prepaid, if mailed; when answered back, if telexed; when receipt acknowledged, if telecopied; and the next Business Day after timely delivery to the courier, if sent by overnight air courier guaranteeing next day delivery.
Any notice or communication to a Holder shall be mailed by first class mail, certified or registered, return receipt requested, or by overnight air courier guaranteeing next day delivery to its address shown on the register kept by the Registrar.
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Any notice or communication shall also be so mailed to any Person described in TIA §313(c), to the extent required by the TIA. Failure to mail a notice or communication to a Holder or any defect in it shall not affect its sufficiency with respect to other Holders.
If a notice or communication is mailed in the manner provided above within the time prescribed, it is duly given, whether or not the addressee receives it.
If the Company mails a notice or communication to Holders, it shall mail a copy to the Trustee and each Agent at the same time.
Section 13.03. Communication by Holders of Notes with Other Holders of Notes.
Holders may communicate pursuant to TIA §312(b) with other Holders with respect to their rights under this Indenture or the Notes. The Company, the Guarantors, the Trustee, the Registrar and anyone else shall have the protection of TIA §312(c).
Section 13.04. Certificate and Opinion As to Conditions Precedent.
Upon any request or application by the Company and/or any Guarantor to the Trustee to take any action or refrain from taking any action under this Indenture, the Company and/or such Guarantor, as the case may be, shall furnish to the Trustee:
Section 13.05. Statements Required in Certificate or Opinion.
Each certificate or opinion with respect to compliance with a condition or covenant provided for in this Indenture (other than a certificate provided pursuant to TIA §314(a)(4)) shall comply with the provisions of TIA §314(e) and shall include:
Section 13.06. Rules by Trustee and Agents.
The Trustee may make reasonable rules for action by or at a meeting of Holders. The Registrar or Paying Agent may make reasonable rules and set reasonable requirements for its functions; provided, that no such rule shall conflict with the terms of this Indenture or the TIA.
Section 13.07. No Personal Liability of Directors, Officers, Employees and Stockholders.
No director, officer, employee, incorporator, stockholder, member, manager or partner of the Company or any Guarantor, as such, shall have any liability for any obligations of the Company or the Guarantors under the Notes, this Indenture, the Note Guarantees or for any claim based on, in respect of, or by reason of, such obligations or their creation. Each Holder by accepting a Note waives and releases all such liability. The waiver and release are part of the consideration for the issuance of the Notes.
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Section 13.08. Governing Law.
THE INDENTURE, THE NOTES, ANY NOTE GUARANTEES AND THE COLLATERAL DOCUMENTS WILL BE GOVERNED BY, AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, WITHOUT GIVING EFFECT TO THE CONFLICTS OF LAW PRINCIPLES THEREOF.
Section 13.09. No Adverse Interpretation of Other Agreements.
This Indenture may not be used to interpret any other indenture, loan or debt agreement of the Company or its Subsidiaries or of any other Person. Any such indenture, loan or debt agreement may not be used to interpret this Indenture, the Notes or the Note Guarantees.
Section 13.10. Successors.
All agreements of the Company and the Guarantors in this Indenture, the Note Guarantees and the Notes shall bind its successors. All agreements of the Trustee in this Indenture shall bind its successors.
Section 13.11. Severability.
In case any provision in this Indenture, the Note Guarantees or in the Notes shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.
Section 13.12. Counterpart Originals.
The parties may sign any number of copies of this Indenture. Each signed copy shall be an original, but all of them together represent the same agreement.
Section 13.13. Table of Contents, Headings, Etc.
The Table of Contents and Headings of the Articles and Sections of this Indenture have been inserted for convenience of reference only, are not to be considered a part of this Indenture and shall in no way modify or restrict any of the terms or provisions hereof.
Section 13.14. Further Instruments and Acts.
Upon request of the Trustee, the Company and the Guarantors will execute and deliver such further instruments and do such further acts as may be reasonably necessary or proper to carry out more effectively the purposes of this Indenture.
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Section 13.15. Limitation on Agreements.
It is the intention of the Company and each Holder that each Holder shall conform strictly to applicable usury laws. Accordingly, if the transactions contemplated hereby or by the Notes, any Collateral Document or any other agreement, instrument or document evidencing, securing or otherwise pertaining to the Note Obligations (collectively, the Documents) would be usurious as to any Holder under any applicable law (including any law mandatorily applicable to such Person notwithstanding the other provisions of this Indenture), then, in that event, notwithstanding anything to the contrary in this Indenture or any other Document, it is agreed that (i) the aggregate of all consideration which constitutes interest under applicable law that is contracted for, taken, reserved, charged or received by any Holder under the Documents shall under no circumstances exceed the maximum nonusurious amount allowed by applicable law and (ii) any sums determined to constitute interest in excess of such legal limit shall, without penalty, be promptly applied to reduce the then outstanding principal of the Note Obligations or, at the recipients option, promptly returned to the Company. In determining whether or not interest exceeds the maximum permitted amount, the Company and any such Holder agree, to the extent necessary, (a) to recharacterize any non-principal payment as principal, fee, expense, premium or other amount rather than as interest, and (b) to amortize, prorate, allocate and spread the total amount of interest throughout the entire contemplated term of the Note Obligations so that the rate or amount of interest does not exceed the legal limit. If at any time the amount of interest is limited by the foregoing, then the amount of interest payable at all times thereafter shall continue to be computed at the maximum nonusurious rate allowed by applicable law until the total amount of interest payable shall equal the total amount of interest that would have been payable under the Documents without such limitation (assuming such interest had been permitted by applicable law). Notwithstanding anything to the contrary contained in this Indenture or the Collateral Documents, the Trustee and the Paying Agent shall have no obligations or liabilities under this Section 13.15.
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Section 14.02. Absolute and Unconditional Obligation; Realizations from Collateral Not Subordinated.
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Section 14.03. Article XIV Not To Prevent Events of Default or Limit Right To Accelerate. The failure to make a payment pursuant to the Notes by reason of any provision in this Article XIV shall not be construed as preventing the occurrence of a Default. Nothing in this Article XIV shall have any effect on the right of the Holders or the Trustee to accelerate the maturity of the Notes.
Section 14.04. Trustee Not Fiduciary for Holders of Senior Debt of the Issuer.The Trustee shall not be deemed to owe any fiduciary duty to the holders of Senior Debt and shall not be liable to any such holders if it shall mistakenly pay over or distribute to Holders or the Company or any other Person, money or assets to which any holders of Senior Debt shall be entitled by virtue of this Article XIV or otherwise.
Section 14.05. Rights of Holders of Senior Debt Not Impaired. No right of any present or future holder of any Senior Debt to enforce the subordination herein shall at any time or in any way be prejudiced or impaired by any act or failure to act on the part of the Company or by any noncompliance by the Company with the terms, provisions and covenants of the Indenture, regardless of any knowledge thereof any such holder may have or be otherwise charged with.
Section 14.06. Modification of Terms of Senior Debt. Any renewal or extension of the time of payment of any Senior Debt or the exercise by the holders of Senior Debt of any of their rights under any instrument creating or evidencing Senior Debt, including, without limitation, the waiver of default thereunder, may be made or done all without notice to or assent from the Holders or the Trustee. No compromise, alteration, amendment, modification, extension, renewal or other change of, or waiver, consent or other action in respect of, any liability or obligation under or in respect of, or of any of the terms, covenants or conditions of any indenture or other instrument under which any Senior Debt is outstanding or of such Senior Debt, whether or not such compromise, alteration, amendment, modification, extension, renewal or other change of, or waiver, consent or other action is in accordance with the provisions or any applicable document, shall in any way alter or affect any of the provisions of this Article or of the Notes relating to the subordination thereof.
[Signatures on following pages]
98
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.
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COMPANY: |
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VERTEX PHARMACEUTICALS |
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By: |
/s/ Matthew Emmens |
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Name: Matthew Emmens |
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Title: Chief Executive Officer |
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
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TRUSTEE: |
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U.S. BANK NATIONAL ASSOCIATION |
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By: |
/s/ Karen Beard |
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Name: Karen Beard |
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Title: Authorized Signatory |
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
F-1
Exhibit 4.2
(Face of Note)
VERTEX PHARMACEUTICALS INCORPORATED
SECURED NOTES DUE 2012
No. 1
$155,000,000
VERTEX PHARMACEUTICALS INCORPORATED, a Massachusetts corporation, for value received, hereby promises to pay to OLMSTED PARK S.A. or registered assigns, the principal sum of One Hundred Fifty-Five Million Dollars on October 31, 2012.
[Remainder of this page left intentionally blank]
VERTEX PHARMACEUTICALS INCORPORATED
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By: |
/s/ Ian F. Smith |
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Name: Ian F. Smith |
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Title: Executive VP and CFO |
This is one of
the Notes referred
to in the within mentioned Indenture:
Dated: September 30, 2009
U.S. BANK
NATIONAL ASSOCIATION,
as Trustee
By: |
/s/ Karen Beard |
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Authorized Signatory |
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(Back of Note)
VERTEX PHARMACEUTICALS INCORPORATED
SECURED NOTES DUE 2012
THIS NOTE WAS ISSUED WITH ORIGINAL ISSUE DISCOUNT FOR PURPOSES OF SECTIONS 1272, 1273 AND 1275 OF THE UNITED STATES INTERNAL REVENUE CODE OF 1986, AS AMENDED. THE ISSUE PRICE OF THIS NOTE WAS 78.8494 % OF ITS PRINCIPAL AMOUNT; THE TOTAL AMOUNT OF ORIGINAL ISSUE DISCOUNT IS $211.51 PER NOTE WITH A PRINCIPAL AMOUNT OF $1,000; THE ISSUE DATE IS SEPTEMBER 30, 2009; AND THE YIELD TO MATURITY IS 8.00% PER YEAR.
THE SECURITY (OR ITS PREDECESSOR) EVIDENCED HEREBY WAS ORIGINALLY ISSUED IN A TRANSACTION EXEMPT FROM REGISTRATION UNDER SECTION 5 OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT), AND THE SECURITY EVIDENCED HEREBY MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN APPLICABLE EXEMPTION THEREFROM. EACH PURCHASER OF THE SECURITY EVIDENCED HEREBY IS HEREBY NOTIFIED THAT THE SELLER MAY BE RELYING ON THE EXEMPTION FROM THE PROVISIONS OF SECTION 5 OF THE SECURITIES ACT PROVIDED BY RULE 144A THEREUNDER. THE HOLDER OF THE SECURITY EVIDENCED HEREBY AGREES FOR THE BENEFIT OF VERTEX PHARMACEUTICALS INCORPORATED (THE COMPANY) THAT (A) SUCH SECURITY MAY BE RESOLD, PLEDGED OR OTHERWISE TRANSFERRED, ONLY (1)(a) INSIDE THE UNITED STATES TO A PERSON WHO THE SELLER REASONABLY BELIEVES IS A QUALIFIED INSTITUTIONAL BUYER (AS DEFINED IN RULE 144A UNDER THE SECURITIES ACT) PURCHASING FOR ITS OWN ACCOUNT OR FOR THE ACCOUNT OF A QUALIFIED INSTITUTIONAL BUYER IN A TRANSACTION MEETING THE REQUIREMENTS OF RULE 144A UNDER THE SECURITIES ACT, (b) OUTSIDE THE UNITED STATES TO A FOREIGN PERSON IN A TRANSACTION MEETING THE REQUIREMENTS OF RULE 903 OR RULE 904 OF REGULATION S UNDER THE SECURITIES ACT (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS), (c) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT PROVIDED BY RULE 144 THEREUNDER (IF APPLICABLE) (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS) OR (d) IN ACCORDANCE WITH
ANOTHER EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT (AND BASED UPON AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY IF THE COMPANY SO REQUESTS), (2) TO THE COMPANY OR (3) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT AND, IN EACH CASE, IN ACCORDANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES OR ANY OTHER APPLICABLE JURISDICTION AND (B) THE HOLDER WILL, AND EACH SUBSEQUENT HOLDER IS REQUIRED TO, NOTIFY ANY PURCHASER OF THE SECURITY EVIDENCED HEREBY OF THE RESALE RESTRICTIONS SET FORTH IN CLAUSE (A) ABOVE. NO REPRESENTATION CAN BE MADE AS TO THE AVAILABILITY OF THE EXEMPTION PROVIDED BY RULE 144 FOR RESALE OF THE SECURITY EVIDENCED HEREBY.
Capitalized terms used herein shall have the meanings assigned to them in the Indenture referred to below unless otherwise indicated. The Notes are general obligations of the Company, secured by Liens on the Collateral as described in the Indenture. This Note is entitled to the benefits of the Note Guarantees by the Guarantors on the terms set forth in the Indenture.
1. Accreted Value; Interest. The Accreted Value of this Note is the amount per $1,000 principal amount at maturity of this Note that is equal to (a) as of any date prior to October 31, 2012, $788.49 accreted at the daily compounding rate equivalent to 8% per year from the Issue Date through the date of determination, computed on the basis of a 365-day year, and (b) as of October 31, 2012, or any date thereafter, $1,000. Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (such corporation, and its successors and assigns under the Indenture, being herein called the Company) promises to pay the Accreted Value of this Note, and, in the circumstances provided in the Indenture, Liquidated Damages, if any. The Company further promises to pay interest (including post-petition interest to the extent permitted in any proceeding under any Bankruptcy Law) on overdue Accreted Value and Liquidated Damages, if any, from time to time on demand at a rate of 12% per annum, and the Company shall also pay interest (including to the extent permitted post-petition interest in any proceeding under any Bankruptcy Law) on overdue installments of interest (without regard to any applicable grace periods) from time to time on demand at the same rate to the extent lawful. Interest will be computed on the basis of a 365-day year.
2. Method of Payment. The Notes will be payable as to Accreted Value, Liquidated Damages, if any, and interest, if any, at the office or agency of the Company maintained for such purpose within the City and State of New York, or, at the option of the Company, payment of interest may be made by check mailed to the Holders at their addresses set forth in the register of Holders, and
provided that payment by wire transfer of immediately available funds will be required with respect to Accreted Value of and interest, and Liquidated Damages, if any, on all Global Notes and all other Notes the Holders of which shall have provided wire transfer instructions to the Company or the Paying Agent. Such payment shall be in such coin or currency of the United States of America as at the time of payment is legal tender for payment of public and private debts.
3. Paying Agent and Registrar. Initially, U.S. Bank National Association, the Trustee under the Indenture, will act as Paying Agent and Registrar. The Company may change any Paying Agent or Registrar without notice to any Holder. The Company or any of its Subsidiaries may act in any such capacity; provided that if the Company or such Subsidiary is acting as Paying Agent, the Company or such Subsidiary shall segregate all funds held by it as Paying Agent and hold them in a separate trust fund for the benefit of the Holders.
4. Indenture. The Company issued the Notes under an Indenture dated as of September 30, 2009 (as supplemented from time to time, the Indenture), among the Company, the Guarantors and the Trustee. The terms of the Notes include those stated in the Indenture and those made part of the Indenture by reference to the Trust Indenture Act of 1939, as amended (15 U.S. Code §§ 77aaa-77bbbb). The Notes are subject to all such terms, and Holders are referred to the Indenture and such Act for a statement of such terms.
The summary of the terms of this Note contained herein does not purport to be complete and is qualified by reference to the Indenture. To the extent permitted by applicable law, in the event of any inconsistency between the terms of this Note and the terms of the Indenture, the terms of the Indenture shall control.
The Indenture restricts, among other things, the Companys and the Guarantors ability to sell or incur liens on Collateral or merge or consolidate with any other person.
5. Optional Redemption.
The Company may redeem the Notes at its option, in whole at any time or in part from time to time, upon not less than 2 nor more than 5 Business Days prior notice electronically delivered or mailed by first-class mail to each Holders registered address, at a redemption price equal to 100% of the Accreted Value of the Notes redeemed plus Liquidated Damages, if any, and accrued and unpaid interest, if any, to, the applicable redemption date (subject to the right of holders of record on the relevant record date to receive interest due on the relevant interest payment date).
6. Mandatory Redemption.
Except as set forth below, the Company shall not be required to make mandatory redemption or sinking fund payments with respect to the Notes.
Upon the occurrence of a Milestone Event as defined in the Janssen Agreement as in effect on the date of the Indenture (whether or not the Janssen Agreement is still in effect or has been subsequently amended, sold or assigned), the Company shall redeem for cash the maximum principal amount at maturity of Notes that may be redeemed with the amount of the Milestone Payment due, under the terms of the Janssen Agreement as in effect on the date of the Indenture, upon the occurrence of the applicable Milestone Event, at a redemption price in cash in an amount equal to 100% of the Accreted Value thereof, plus accrued and unpaid interest and Liquidated Damages, if any, to the date fixed for the closing of such redemption in accordance with the procedures set forth in the Indenture. Any such redemption shall be made pursuant to the provisions of Sections 3.01 through 3.06 of the Indenture.
7. Repurchase at Option of Holder. If a Change of Control occurs, each Holder will have the right to require the Company to repurchase all or any part (equal to $50,000 or an integral multiple of $1,000 in excess thereof) of that Holders Notes pursuant to an offer (a Change of Control Offer) on the terms set forth in the Indenture. In the Change of Control Offer, the Company shall offer payment (a Change of Control Payment) in cash equal to 100% of the aggregate Accreted Value of Notes repurchased plus accrued and unpaid interest and Liquidated Damages thereon to the date of repurchase (the Change of Control Payment Date, which date will be no earlier than the date of such Change of Control). No later than 30 days following any Change of Control, the Company shall mail a notice to each Holder stating that a Change of Control has occurred and offering to repurchase Notes on the Change of Control Payment Date specified in such notice, which date will be no earlier than 30 days and no later than 60 days from the date such notice is mailed, pursuant to the procedures required by the Indenture and described in such notice.
8. Notice of Redemption. Notice of redemption will be electronically delivered or mailed at least 2 days but not more than 5 Business Days before the redemption date to each Holder whose Notes are to be redeemed at its registered address. Notes in denominations larger than $50,000 may be redeemed in part but only in whole multiples of $1,000, unless all of the Notes held by a Holder are to be redeemed. On and after the redemption date, interest ceases to accrue on Notes or portions thereof called for redemption.
9. Denominations, Transfer, Exchange. The Notes are in registered form without coupons in denominations of $50,000 principal amount at maturity
and integral multiples of $1,000 in excess thereof. The transfer of Notes may be registered and Notes may be exchanged as provided in the Indenture. The Registrar and the Trustee may require a Holder, among other things, to furnish appropriate endorsements and transfer documents and the Company may require a Holder to pay any taxes and fees required by law or permitted by the Indenture. The Company need not exchange or register the transfer of any Note or portion of a Note selected for redemption, except for the unredeemed portion of any Note being redeemed in part.
10. Persons Deemed Owners. The registered Holder of a Note may be treated as its owner for all purposes.
11. Amendment, Supplement and Waiver. Subject to certain exceptions, the Indenture, the Notes, the Note Guarantees and the Collateral Documents may be amended or supplemented with the consent of the Holders of at least a majority in aggregate principal amount of the Notes then outstanding (including, without limitation, consents obtained in connection with a tender offer or exchange offer for the Notes), and, subject to the terms of the Indenture, any existing Default or Event of Default (other than a Default or Event of Default in the payment of the Accreted Value of, Liquidated Damages, if any, or interest on the Notes, except a payment default resulting from an acceleration that has been rescinded) or compliance with any provision of the Indenture or the Notes may be waived with the consent of the Holders of a majority in aggregate principal amount of the then outstanding Notes (including, without limitation, consents obtained in connection with a tender offer or exchange offer for the Notes). Certain provisions in the Indenture, Notes, Notes Guarantees and Collateral Documents may be amended or supplemented without the consent of any Holder of a Note. Certain provisions in the Indenture, Notes, Notes Guarantees and Collateral Documents may not be amended or supplemented without the consent of every Holder affected thereby.
12. Defaults and Remedies. The Indenture contains certain Events of Default.
If any Event of Default (other than an Event of Default specified in clause (d) or (e) of Section 6.01 with respect to the Company) occurs and is continuing, the Trustee or the Holders of at least 25% in aggregate principal amount at maturity of the then outstanding Notes may declare all the Notes to be due and payable immediately. Notwithstanding the foregoing, if an Event of Default specified in clause (d) or (e) of Section 6.01 occurs with respect to the Company, all outstanding Notes will become due and immediately payable without further action or notice. Upon any Note becoming due and payable under the Indenture, whether automatically or by declaration, such Note will forthwith mature and the entire unpaid Accreted Value of such Note, plus (1) all accrued and
unpaid interest thereon and (2) Liquidated Damages, if any, determined in respect of such Accreted Value shall all be immediately due and payable. Upon acceleration of the Notes, Accreted Value shall cease to accrete and Liquidated Damages will be calculated as of the date of such acceleration, but interest will accrue on the Accreted Value and the Liquidated Damages at the rate provided for overdue Accreted Value and Liquidated Damages on the Notes in Section 1 hereof and Section 4.01 of the Indenture until such Accreted Value and Liquidated Damages are paid. Holders may not enforce the Indenture or the Notes except as provided in the Indenture. Subject to certain limitations, Holders of a majority in aggregate principal amount at maturity of the then outstanding Notes may direct the Trustee in its exercise of any trust or power. The Trustee may withhold from Holders of the Notes notice of any continuing Default or Event of Default (except a Default or Event of Default relating to the payment of principal or interest) if it determines that withholding notice is in their interest. The Company is required to deliver to the Trustee annually a statement regarding compliance with the Indenture, and the Company is required upon becoming aware of any Default or Event of Default, to deliver to the Trustee a statement specifying such Default or Event of Default.
13. Trustee and Collateral Agent Dealings with Company. Each of the Trustee and the Collateral Agent, in its individual or any other capacity, may make loans to, accept deposits from, and perform services for the Company or its Affiliates, and may otherwise deal with the Company or its Affiliates, as if it were not the Trustee and/or the Collateral Agent, as the case may be.
14. No Recourse Against Others. No director, officer, employee, incorporator, stockholder, member, manager or partner of the Company or any Guarantor, as such, shall have any liability for any obligations of the Company or the Guarantors under the Notes, the Indenture, the Note Guarantees or for any claim based on, in respect of, or by reason of, such obligations or their creation. Each Holder by accepting a Note waives and releases all such liability. The waiver and release are part of the consideration for the issuance of the Notes.
15. Collateral. The due and punctual payment of the Accreted Value of, Liquidated Damages, if any, on and interest on, the Notes and all other Note Obligations are secured as provided in the Security Agreement, which the Company and the Guarantors have entered into simultaneously with the execution of the Indenture, and the other Collateral Documents in effect from time to time. Each Holder, by its acceptance thereof, consents and agrees to the terms of the Collateral Documents (including, without limitation, the provisions providing for foreclosure and release of Collateral) as the same may be in effect or may be amended, supplemented or otherwise modified from time to time in accordance with their terms and authorizes and directs the Collateral Agent or the Trustee (as
the case may be) to enter into the Collateral Documents and to perform their obligations and exercise their rights thereunder in accordance therewith.
16. Subordination. The Company agrees, and each Holder by accepting a Note agrees, that the Note Obligations are expressly subordinated hereby, and as provided in the Indenture, in right of payment to the prior payment in full of all Senior Debt, provided that such subordination shall not apply to the rights of the Holders to receive Payments from Collateral, as defined in the Indenture, in accordance with Section 14.02 of the Indenture.
17. Authentication. This Note shall not be valid until authenticated by the manual signature of the Trustee or an authenticating agent.
18. Abbreviations. Customary abbreviations may be used in the name of a Holder or an assignee, such as: TEN COM (= tenants in common), TEN ENT (= tenants by the entireties), JE TEN (= joint tenants with right of survivorship and not as tenants in common), CUST (= Custodian), and U/G/M/A (= Uniform Gifts to Minors Act).
19. CUSIP Numbers. Pursuant to a recommendation promulgated by the Committee on Uniform Security Identification Procedures, the Company has caused CUSIP numbers to be printed on the Notes and the Trustee may use CUSIP numbers in notices of redemption as a convenience to Holders. No representation is made as to the accuracy of such numbers either as printed on the Notes or as contained in any notice of redemption and reliance may be placed only on the other identification numbers placed thereon.
The Company shall furnish to any Holder upon written request and without charge a copy of the Indenture. Requests may be made to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Investor Relations
20. Unclaimed Money. Subject to certain conditions, if money for the payment of Accreted Value, Liquidated Damages, if any, or interest remains unclaimed for two years, the Trustee or Paying Agent shall pay the money back to the Company at its request in accordance with the Indenture, unless any abandoned property law designates another Person. After any such payment, Holders entitled to the money must look only to the Company and not to the Trustee for payment unless such abandoned property law designates another Person.
21. Discharge and Defeasance. Subject to certain conditions, the Company at any time may terminate some or all of the obligations of the Company under the Notes and the Indenture if the Company irrevocably deposits in trust with the Trustee an amount in United States dollars sufficient to pay and discharge the entire Indebtedness on the Notes, not theretofore delivered for cancellation, including the Accreted Value of, Liquidated Damages, if any, and accrued interest on such Notes at such maturity, Stated Maturity or redemption date, as the case may be.
22. Governing Law. THE INDENTURE AND THIS NOTE WILL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, WITHOUT GIVING EFFECT TO THE CONFLICTS OF LAW PRINCIPLES THEREOF.
ASSIGNMENT FORM
To assign this Note, fill in the form below:
(I) or (we) assign and transfer this Note to:
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(Insert Assignees legal name) |
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(Insert assignees soc, sec, or tax I.D. no.) |
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(Print or type assignees name, address and zip code) |
and irrevocably appoint
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to transfer this Note on the books of the Company. The agent may substitute another to act for him.
Date: |
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Your Signature: |
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(Sign exactly as your name appears on the face of this Note) |
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Signature Guarantee: |
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Participant in a recognized Signature Guarantee Medallion Program (or other signature guarantor acceptable to the Trustee).
OPTION OF HOLDER TO ELECT PURCHASE
If you want to elect to have this Note purchased by the Company pursuant to Section 4.08 of the Indenture, check the appropriate box below:
o Section 4.08.
If you want to elect to have only part of the Note purchased by the Company pursuant to Section 4.08 of the Indenture, state the amount you elect to have purchased:
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Date: |
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Your Signature: |
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(Sign exactly as your name appears on the face of this Note)
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Tax Identification No: |
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Signature Guarantee*: |
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*Participant in a recognized Signature Guarantee Medallion Program (or other signature guarantor acceptable to the Trustee).
Exhibit 10.1
Confidential Treatment Requested
Confidential portions of this document have been redacted and have been separately filed with the Commission
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
between
Vertex Pharmaceuticals Incorporated
and
Mitsubishi Pharma Corporation
Information redacted
pursuant to a confidential treatment request.
An unredacted version of this
exhibit has been filed separately with the Commission
TABLE OF CONTENTS
ARTICLE I DEFINITIONS |
1 |
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ARTICLE II LICENSE |
9 |
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2.1 |
Grant to MITSUBISHI |
9 |
2.2 |
Competing Product |
10 |
2.3 |
Grant to VERTEX |
10 |
2.4 |
Transfer of Know-How |
11 |
2.5 |
No Implied Rights |
11 |
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ARTICLE III DEVELOPMENT |
11 |
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3.1 |
Joint Development Committee |
11 |
3.2 |
Development Plans |
13 |
3.3 |
Development Costs |
15 |
3.4 |
[***] |
16 |
3.5 |
Data Transfer |
16 |
3.6 |
Regulatory Matters |
18 |
3.7 |
Conduct of the Development Activities |
19 |
3.8 |
Ownership of Technology |
20 |
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ARTICLE IV MANUFACTURE AND SUPPLY |
20 |
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4.1 |
Supply of Bulk Drug Substance and Drug Product for Development |
20 |
4.2 |
Supply of Bulk Drug Substance and Drug Product for Commercial Purposes |
21 |
4.3 |
Limitation on Supply Obligation |
21 |
4.4 |
Second Source of Supply for Bulk Drug Substance |
22 |
4.5 |
Manufacturing Technology |
22 |
4.6 |
Packaging |
22 |
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ARTICLE V COMMERCIALIZATION |
23 |
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5.1 |
Global Marketing and Sales |
23 |
5.2 |
Co-Labeling |
23 |
5.3 |
Trademarks |
23 |
5.4 |
Due Diligence |
23 |
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ARTICLE VI PAYMENTS |
24 |
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6.1 |
License Fee |
24 |
6.2 |
Milestone Payments by MITSUBISHI |
24 |
6.3 |
Commercial Supply of Drug Product |
26 |
6.4 |
Production of Bulk Drug Substance by MITSUBISHI |
26 |
6.5 |
Royalties on Net Sales of Drug Product; Sales Reports |
27 |
6.6 |
Withholding Tax |
29 |
6.7 |
Currency of Payment |
29 |
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ARTICLE VII TECHNOLOGY |
30 |
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7.1 |
Ownership |
30 |
7.2 |
Patent Procurement and Maintenance |
30 |
7.3 |
Costs |
31 |
i
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission
7.4 |
Infringement Claims by Third Parties |
32 |
7.5 |
Infringement Claims against Third Parties |
33 |
7.6 |
Patent Term Extensions |
34 |
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ARTICLE VIII REPRESENTATIONS AND WARRANTIES |
34 |
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8.1 |
Representations and Warranties of VERTEX |
34 |
8.2 |
Representations and Warranties of MITSUBISH |
35 |
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ARTICLE IX CONFIDENTIALITY |
35 |
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9.1 |
Undertaking |
35 |
9.2 |
Exceptions |
37 |
9.3 |
Publicity |
37 |
9.4 |
Survival |
38 |
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ARTICLE X DISPUTE RESOLUTION |
38 |
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10.1 |
Governing Law and Jurisdiction |
38 |
10.2 |
Dispute Resolution Process |
38 |
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ARTICLE XI TERM AND TERMINATION |
39 |
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11.1 |
Term |
39 |
11.2 |
Termination for Cause |
40 |
11.3 |
Termination for Bankruptcy |
40 |
11.4 |
Termination by MITSUBISHI |
40 |
11.5 |
Effect of Termination |
41 |
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ARTICLE XII INDEMNIFICATION |
42 |
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12.1 |
Indemnification by VERTEX |
42 |
12.2 |
Indemnification by MITSUBISHI |
42 |
12.3 |
Claims Procedures |
43 |
12.4 |
Limitation of Liability |
44 |
12.5 |
Insurance |
44 |
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ARTICLE XIII MISCELLANEOUS PROVISIONS |
44 |
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13.1 |
Waiver |
44 |
13.2 |
Force Majeure |
44 |
13.3 |
Registration of License |
45 |
13.4 |
Severability |
45 |
13.5 |
Government Acts |
45 |
13.6 |
Government Approvals |
45 |
13.7 |
Assignment; Successors and Assigns |
46 |
13.8 |
Export Controls |
46 |
13.9 |
Affiliates |
46 |
13.10 |
Counterparts |
47 |
13.11 |
No Agency |
47 |
13.12 |
Notice |
47 |
13.13 |
Headings |
47 |
13.14 |
Entire Agreement |
47 |
13.15 |
Rules of Construction |
48 |
ii
Information redacted pursuant to a confidential
treatment request. An unredacted version
of this
exhibit has been filed separately with the Commission.
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the Agreement) is made and entered into as of June 11, 2004 between VERTEX PHARMACEUTICALS INCORPORATED (hereinafter VERTEX), a Massachusetts corporation with principal offices at 130 Waverly Street, Cambridge, MA 02139-4242, and MITSUBISHI PHARMA CORPORATION (hereinafter MITSUBISHI), a Japanese corporation with principal offices at 6-9, Hiranomachi 2-Chome, Chuo-ku, Osaka 541-0046, Japan. VERTEX and MITSUBISHI are sometimes referred to herein individually as the Party and collectively as the Parties.
INTRODUCTION
WHEREAS, VERTEX has an ongoing antiviral drug discovery and development program targeting the hepatitis C virus (HCV) NS3 4A protease; and
WHEREAS, VERTEXs discovery and development program has produced a clinical candidate known as VX-950 that is currently in late preclinical development and a back-up compound VX-905 (the Compounds); and
WHEREAS, MITSUBISHI wishes to obtain an exclusive license to develop and commercialize the Compounds in Japan and certain Asian countries, and VERTEX is willing to grant such a license, all on the terms and subject to the conditions set forth herein; and
NOW THEREFORE, in consideration of the foregoing premises, the mutual covenants set forth herein, and other good and valuable consideration, the Parties agree as follows:
License, Development and Commercialization Agreement Confidential
Information redacted
pursuant to a confidential treatment request.
An unredacted version of this
exhibit has been filed separately with the Commission.
2
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
3
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
4
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
5
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
(d) In the case of any sale which is not invoiced, the Net Sales Price shall be calculated at the time of shipment or when the Drug Product is paid for, if paid for before shipment, based on the gross purchase price.
6
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
7
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
8
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
9
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
10
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
11
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
MITSUBISHI will prepare the initial draft of an agenda for each JDC meeting and will submit the draft to VERTEX for comments a reasonable period before the scheduled meeting
12
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
date. The Party hosting a particular JDC meeting shall prepare and deliver to the members of the JDC, within [***] days after the date of each meeting, minutes of such meeting setting forth, among other things, all decisions of the JDC, and including a summary of the status of development activities as reported to the JDC. The Party not preparing the minutes may suggest changes or amendments to the minutes, and may provide a supplement addressing activities at the meeting that are not reported in the minutes, which shall be distributed to the Parties and filed with the meeting minutes. In case the JDC meets by means of telephone or video conferences, the responsibility for preparing minutes shall lie with MITSUBISHI.
13
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
14
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
15
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
(a) MITSUBISHI shall provide to VERTEX all relevant preclinical and non-clinical data, assays and associated materials, protocols, methods, processes, techniques, commercial assessments of potential Indications, and any other relevant information or materials with respect to a Compound, that are Controlled by and in the possession of MITSUBISHI or its Affiliates and produced in the performance of the MITSUBISHI Development Activities during the term of this Agreement. Available information and materials shall be delivered by MITSUBISHI to the JDC, at MITSUBISHIs expense, within thirty (30) days after the end of each calendar quarter during the term of this Agreement in an orderly fashion and in a manner such that the value of the delivered information and materials is preserved in all material respects. Such information and materials shall be deemed Confidential Information of MITSUBISHI subject to the terms and conditions set forth in Article IX. MITSUBISHI shall enter
16
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
into customary agreements with its sublicensees that provide that such sublicensees shall supply MITSUBISHI with relevant preclinical and non-clinical data, assays and associated materials, protocols, methods, processes, techniques, commercial assessments of potential Indications, and any other relevant information or materials with respect to a Compound produced in the performance of the MITSUBISHI Development Activities.
(b) VERTEX shall provide to MITSUBISHI all relevant preclinical and non-clinical data, assays and associated materials, protocols, methods, processes, techniques, commercial assessments of potential Indications, and any other relevant information or materials with respect to a Compound, that are Controlled by and in the possession of VERTEX or its Affiliates and produced in the performance of the VERTEX Development Activities before and during the term of this Agreement. Available information and materials shall be delivered by VERTEX to the JDC, at VERTEXs expense, within thirty (30) days after the end of each calendar quarter during the term of this Agreement in an orderly fashion and in a manner such that the value of the delivered information and materials is preserved in all material respects. Such information and materials shall be deemed Confidential Information of VERTEX subject to the terms and conditions set forth in Article IX. VERTEX shall enter into customary agreements with the VERTEX Licensees that provide that the VERTEX Licensees shall supply VERTEX with relevant preclinical and non-clinical data, assays and associated materials, protocols, methods, processes, techniques, commercial assessments of potential Indications, and any other relevant information or materials with respect to a Compound produced in the performance of the VERTEX Development Activities.
17
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
18
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
19
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
20
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
21
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
22
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
23
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
6.1 License Fee. In consideration of the grant of the license set forth in Section 2.1 hereof and in recognition of VERTEXs investment in the Compounds prior to the Effective Date, MITSUBISHI will pay to VERTEX [***] on or before [***].
24
Information
redacted pursuant to a confidential treatment request. An unredacted version of this
exhibit has been filed separately with the Commission.
Milestone |
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Payment |
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1. First dosing of the first Compound in a patient in a Phase Ib Clinical Trial in the VERTEX Territory |
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US $ |
4,000,000 |
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2. First dosing of the Compound in a human in a Phase I Clinical Trial in the Territory |
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US $ |
3,000,000 |
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3. First dosing of the Compound in a patient in a Phase II Clinical Trial in the Territory |
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US $ |
2,000,000 |
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4. First dosing of the Compound in a patient in a Phase III Clinical Trial in the Territory |
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US $ |
2,000,000 |
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5. First [***] |
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US $ |
[***] |
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6. First [***] |
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US $ |
[***] |
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US $ |
[***] |
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6.2.3 Timing and Method of Payments. Milestone payments shall be made on or before the [***] following the occurrence of the event giving rise to the milestone payment obligation hereunder. All payments shall be made by wire transfer in U.S. dollars to the credit of such bank account as may be designated by VERTEX in writing to MITSUBISHI from time to time. Any payment which falls due on a date which is a Saturday, Sunday, MITSUBISHIs non-working day or a legal holiday in Japan may be made on the next succeeding day which is not a Saturday, Sunday, MITSUBISHIs non-working day or a legal holiday in Japan.
25
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
26
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
27
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
28
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
29
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
30
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
31
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
32
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
33
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
34
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
(d) Chiron Patents. VERTEXs research activities that produced the Compounds are covered by a license granted to VERTEX by Chiron Corporation under certain intellectual property with respect to the hepatitis C virus (HCV). Vertex is not aware of any further license that would be required from Chiron Corporation to permit MITSUBISHI to develop and commercialize the Compounds and the Drug Products pursuant to this Agreement.
35
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
36
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
37
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
38
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
39
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
40
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
41
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
42
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
43
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
44
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
45
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
46
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
If to MITSUBISHI, at:
Mitsubishi Pharma Corporation
6-9, Hiranomachi 2 Chome, Chuo-ku
Osaka 541-0046, Japan
Fax: 81-6-6227-4702
Attention: General Manager of Corporate Licensing Department
If to VERTEX, at:
Vertex Pharmaceutical Incorporated
130 Waverly Street
Cambridge, MA U.S.A. 02139-4211
Fax: 617-444-7117
Attention: General Counsel
47
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
[Signature Page Follows]
48
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed and delivered by their duly authorized representatives as of the day and year first above written.
VERTEX PHARMACEUTICALS INCORPORATED |
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By: |
/s/ Joshua S. Boger |
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Name: |
Joshua S. Boger, Ph.D. |
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Title: |
Chairman and Chief Executive Officer |
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Witness |
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By: |
/s/ Vicki L. Sato |
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Name: |
Vicki L. Sato, Ph.D. |
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Title: |
President |
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MITSUBISHI PHARMA CORPORATION |
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By: |
/s/ Teruo Kobori |
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Name: |
Teruo Kobori |
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Title: |
President & Chief Executive Officer |
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Witness |
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By: |
/s/ Akihiro Tobe |
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Name: |
Akihiro Tobe, Ph.D. |
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Title: |
Managing Executive Officer, Division Manager, Strategic Planning Division |
49
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
Schedule 1.33
MITSUBISHI Patents
None as of the Effective Date.
50
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
Schedule 1.49
Territory
[***]
Japan
[***]
Peoples Republic of China
51
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
Schedule 1.56
VERTEX Patents
DOCKET NO |
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SERIAL NO |
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PATENT NO |
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TITLE |
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COUNTRY |
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STATUS |
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FILED |
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ISSUED |
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VPI/00-131 CN |
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01815055.1 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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CHINA |
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PENDING |
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8/31/01 |
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VPI/00-131 EA |
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200300318 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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EURASIA |
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PENDING |
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8/31/01 |
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VPI/00-131 HK |
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Awaiting confirmation |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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HONG KONG |
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PENIDNG |
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Awaiting confirmation |
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VPI/00-131 ID |
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W-00 200300420 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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INDONESIA |
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PENDING |
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8/31/01 |
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VPI/00-131 JP |
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2002-523884 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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JAPAN |
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PENDING |
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8/31/01 |
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VPI/00-131 KR |
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10-2003-700-2880 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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SOUTH KOREA |
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PENDING |
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8/31/01 |
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VPI/00-131 MY |
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PI20014137 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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MALAYSIA |
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PENDING |
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9/3/01 |
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VPI/00-131 PH |
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1-2003-500074 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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PHILIPPINES |
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PENDING |
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8/31/01 |
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VPI/00-131 SG |
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200300451-2 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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SINGAPORE |
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PENDING |
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8/31/01 |
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VPI/00-131 TH |
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068019 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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THAILAND |
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PENDING |
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8/30/01 |
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VPI/00-131 TW |
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90121629 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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TAIWAN |
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PENDING |
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8/31/01 |
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VPI/00-131 VN |
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1-2003-00183 |
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PEPTIDOMIMETIC PROTEASE INHIBITORS |
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VIET NAM |
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PENDING |
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8/31/01 |
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VPI/96-11 CN |
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97180151.7 |
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INHIBITORS OF SERINE PROTEASES, PARTICULARLY HEPATITIS C VIRUS NS3 PROTEASE |
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CHINA |
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ALLOWED |
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10/17/1997 |
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VPI/96-11 EA |
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199900388 |
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001915 |
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INHIBITORS OF SERINE PROTEASES, PARTICULARLY HEPATITIS C VIRUS NS3 PROTEASE |
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EURASIAN PATENT OFFICE |
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ISSUED |
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10/17/1997 |
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10/22/01 |
52
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
Schedule 1.59
VX-905
[***]
53
Information redacted pursuant to
a confidential treatment request. An
unredacted version of this
exhibit has been filed separately with the Commission.
Schedule 1.60
VX-950
54
Exhibit 10.2
Confidential Treatment Requested.
Confidential portions of this document have been redacted and have been separately filed with the Commission.
SECOND AMENDMENT TO LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS SECOND AMENDMENT (this Amendment) is made and entered into as of July 30, 2009 (the Amendment Date) by and between Vertex Pharmaceuticals Incorporated (VERTEX) and Mitsubishi Tanabe Pharma Corporation, as successor-in-interest to Mitsubishi Pharma Corporation (the successor, MITSUBISHI):
WHEREAS, VERTEX and MITSUBISHI are the parties to that certain License, Development and Commercialization Agreement dated effective as of June 11, 2004, as amended by the First Amendment dated July 27, 2004 and the letter dated December 9, 2004 (collectively the Agreement), with respect to, among other things, development and commercialization of VERTEXs hepatitis C protease inhibitor known as VX-950, or telaprevir (hereinafter, telaprevir); and
WHEREAS, the Parties wish to amend the Agreement to reflect the matters that have arisen in the conduct of discussions between them;
NOW, THEREFORE, the Parties hereto hereby agree as set forth below.
1. Definitions.
The terms defined in this Section 1 and parenthetically elsewhere, including in the whereas clauses, shall have the same meaning throughout in this Amendment. Capitalized terms used in this Amendment without specific definition shall have the same meaning set forth in the Agreement.
1.1 Drug Product for purposes of this Amendment shall mean Drug Product incorporating telaprevir.
1.2 Drug Substance shall mean telaprevir manufactured in bulk form [***].
1.3 Raw Materials shall mean the materials incorporated into Drug Substance [***], which are set forth on Exhibit A.
1.4 [***].
2. Payments to VERTEX.
2.1 Initial Payment by MITSUBISHI. In consideration of the agreements between the Parties set forth in this Amendment, including but not limited to the agreement by VERTEX to provide clinical and CMC data as set forth in Articles 3 and 5 of this Amendment, MITSUBISHI shall pay to VERTEX (i) One Hundred and Five Million U.S. Dollars ($105,000,000) (Initial Amount) on August 12, 2009, and (ii) an
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
additional payment, if any, in the amount and at the time set forth in Section 2.2 below, in each case by wire transfer to VERTEXs designated bank account.
2.2 Additional Payment by MITSUBISHI. MITSUBISHI shall make an additional payment to VERTEX in the amount as set forth in the table below [***]. MITSUBISHI shall make this additional payment to VERTEX, if required, within [***]. [***], MITSUBISHI shall make an additional payment to VERTEX in the amount of the difference between the amount of any payment previously made under this paragraph 2.2, and the amount set forth opposite [***], in such case within [***].
[***] |
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Payment to VERTEX |
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[***] |
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$15 million |
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[***] |
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[***] |
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[***] |
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[***] |
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[***] |
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[***] |
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[***] |
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$65 million |
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2.3 MITSUBISHIs Audit Right.
(a) VERTEX shall keep accurate records of the telaprevir development costs in the VERTEX Territory and shall permit MITSUBISHI to verify the amounts of such costs as provided in this Section 2.3. MITSUBISHI may exercise, at its option, such right of inspection and audit by giving VERTEX a written notice any time after the Amendment Date, provided that any such audit and inspection shall be completed in their entirety on or before July 30, 2010 and any payment to MITSUBISHI under Section 2.3(d) below shall be made on or before October 31, 2010. This right of inspection and audit may be exercised by MITSUBISHI one time only.
(b) Upon such notice from MITSUBISHI provided at least [***] before commencement of an audit under Section 2.3(a) above, VERTEX shall permit an independent accounting firm of national prominence selected by MITSUBISHI and approved by VERTEX, which approval shall not be unreasonably withheld or delayed, to have such access, during normal business hours and for not more than [***], to VERTEX records as is reasonably necessary to verify the accuracy of VERTEXs costs to develop telaprevir for combination therapy incurred on or before December 31, 2008 (the Cost Measurement Date) set forth on Exhibit B attached hereto. The records to be provided hereunder shall be limited to VERTEX records that are not subject to confidentiality obligations to Third Parties. The Parties acknowledge and agree that the amounts payable by MITSUBISHI under this Section 2 have been determined taking into
2
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
consideration VERTEXs costs to develop telaprevir for combination therapy set forth on Exhibit B attached hereto.
(c) Any report prepared by such independent accounting firm, a copy of which shall be sent or otherwise provided to VERTEX at the same time it is provided to MITSUBISHI, shall contain the conclusions of such independent accounting firm regarding the audit and will specify in detail the discrepancies between the costs set forth on Exhibit B, and those determined in the audit.
(d) If the independent accounting firms report shows that VERTEXs costs to develop telaprevir for combination therapy incurred on or before the Cost Measurement Date were [***], VERTEX shall refund to MITSUBISHI [***]. This adjustment to be repaid to MITSUBISHI, if any, pursuant to this Section 2.3(d) shall be the sole remedy for breach by VERTEX of the representation set forth in Section 13(a) of this Amendment.
(e) The costs incurred in the conduct of any audit under this Section 2.3 shall be borne exclusively by MITSUBISHI, provided that, if the adjustment is made as a result of the audit findings pursuant to subsection (d) above, VERTEX shall reimburse MITSUBISHI for the reasonable costs and expenses of the audit.
3. MITSUBISHI Use of VERTEX Combination Therapy Clinical Data. On the Amendment Date, VERTEX shall provide to MITSUBISHI the clinical study reports for any telaprevir combination clinical trials that are complete[***]. VERTEX shall provide MITSUBISHI with any and all data to be provided pursuant to Sections 3.5.1(b) and 3.5.2(b) of the Agreement, including clinical data from VERTEXs or VERTEX Licensees clinical investigation of telaprevir combination therapy, to the extent required or useful for or in connection with obtaining and maintaining the Regulatory Approval in the Territory [***], provided that VERTEX shall not be required to provide clinical data generated on or after the date that the first Regulatory Approval for telaprevir in Japan is obtained[***], as of the Amendment Date. Subject to the provisions of Section 3.7 of the Agreement and the terms of this Amendment, MITSUBISHI shall be entitled to receive, use, handle or refer to, for any and all purposes permitted under the Agreement, in the Territory, any and all such data at any time. Such data provided to MITSUBISHI by VERTEX shall include, but not be limited to, data and information derived from the clinical trials listed in Exhibit C attached hereto. VERTEXs obligations under Sections 3.5.1(b) and 3.5.2(b) of the Agreement shall be satisfied in full upon delivery of the data described in this Section 3. Notwithstanding the foregoing, (i) VERTEX shall not be required to provide data or information deriving from [***]; and (ii) VERTEX shall not be required under any circumstances to provide data or information from any studies [***].
4. Supply of Telaprevir.
4.1 VERTEX Supply Agreements. The commercial supply agreement and quality agreements of even date herewith between the Parties satisfy the obligations of the Parties related to entering into the Commercial Supply Agreement set forth in Section 4.2 of and referred to elsewhere in the Agreement. The commercial supply agreement and
3
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
quality agreements, together with the Development Supply Agreement dated April 28, 2005 between the Parties (collectively VERTEX Supply Agreements), shall reflect VERTEXs only obligations to supply Bulk Drug Substance[***], or Drug Product (or any other material incorporating telaprevir as the active pharmaceutical ingredient) to MITSUBISHI, at any time and for any purpose from and after the Amendment Date.
4.2 MITSUBISHI to Supply after Termination of VERTEX Supply Agreements. Upon the termination of all of the VERTEX Supply Agreements, MITSUBISHI shall have the sole responsibility under the Agreement, at its expense, for the manufacture of all Raw Materials, Drug Substance [***] to meet its, its Affiliates and its sublicensees requirements in connection with the development and commercial sale of the Drug Product in the Territory and VERTEX shall have no further obligation to provide information or notice or copies of regulatory correspondence or filings under Section 3.6.2 of the Agreement or otherwise, to the extent that such information, correspondence or filings pertain to drug substance or formulation of Drug Product other than in the form currently being supplied by VERTEX under the VERTEX Supply Agreements.
4.3 Manufacturing License under the VERTEX Technology. VERTEX hereby grants to MITSUBISHI a nonexclusive license (or sublicense, as appropriate) under the VERTEX Technology, with the right to sublicense, to manufacture and have manufactured Drug Substance, Raw Materials [***] in and outside of the Territory to the extent required for MITSUBISHI to use, sell, have sold, offer to sell and import Drug Products in the Territory in the Field of Use.
5. VERTEX Assistance/Technical Transfer.
(a) VERTEX shall complete the transfer of VERTEX Technology relating to the manufacture [***] (including all VERTEX Technology applicable to manufacture of Raw Materials and Drug Substance) to MITSUBISHI immediately following the Amendment Date. During such transfer, VERTEX shall provide MITSUBISHI with the information and data relating to the manufacture of [***], Raw Material and Drug Substance, which information and data shall include, but not be limited to, the information and data as of the Amendment Date as listed in Exhibit D attached hereto.
(b) From and after the Amendment Date until, at the latest, the termination of the VERTEX Supply Agreements, VERTEX shall facilitate discussions between MITSUBISHI and Third Party suppliers, including suppliers of Raw Materials, Drug Substance [***], directed toward the establishment of a direct contractual relationship between MITSUBISHI and such suppliers [***]. In connection therewith, VERTEX shall permit MITSUBISHI to take a technical review at the site of each of the Third Party suppliers of Raw Materials, in each case at a time and place that is reasonably acceptable to MITSUBISHI and each such supplier.
(c) VERTEX shall provide to MITSUBISHI the technical support reasonably necessary to enable MITSUBISHI to exploit the VERTEX Technology in order to manufacture Raw Materials, Drug Substance [***], provided, however, that VERTEXs obligation to provide such technical support shall terminate no later than the date of
4
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
expiration or termination of the VERTEX Supply Agreements. MITSUBISHI shall bear the reasonable out-of-pocket costs incurred by VERTEX for VERTEXs technical assistance. Such VERTEX Technology shall be delivered to MITSUBISHI in such a way as to communicate it to MITSUBISHI promptly, effectively and economically.
(d) During the term of the VERTEX Supply Agreements, both Parties agree to hold meetings to exchange information relating to manufacture and supply of Raw Materials, Drug Substance [***], at such frequency and location as the Parties may agree.
(e) [***].
6. [***]. MITSUBISHI agrees that it shall, and it shall cause its suppliers to, prepare [***] strictly in accordance with technical procedures provided to MITSUBISHI by VERTEX. Notwithstanding the foregoing, MITSUBISHI may make minor changes to the Drug Product formulation to [***], bioequivalence is proven and there is no potential material adverse effect on the market for the Drug Product. With respect to any such changes in Drug Product formulation permitted above, at the time any such project is officially authorized for development, MITSUBISHI shall deliver to VERTEX any and all relevant CMC development and clinical plans, and any subsequently generated data and information. VERTEX shall have the right, at its option, to make comments on any such plans, data and information and MITSUBISHI shall consider VERTEXs comments, if any, in good faith. The technical procedures to be provided shall be those applicable to the production of Drug Product in the form to be supplied by VERTEX under the Commercial Supply Agreement.
7. Deletion of Agreement Provisions. MITSUBISHI shall not owe or pay any royalties to VERTEX for Net Sales of Drug Products in the Territory. Sections 3.3.2, 3.3.3, 3.4, 4.1, 4.2, 4.3, 4.4, 6.3, 6.4, 6.5.1, 6.5.2 and 6.5.3, and the second and third sentences and the last two sentences of Section 3.3.1 of the Agreement are deleted from the Agreement in their entirety as of the Amendment Date. Section 6.5.4 of the Agreement shall be amended to delete (ii) amounts due VERTEX under Sections 6.5.1 or 6.5.2 hereof with respect to such Net Sales, and the basis for calculating those amounts due;. The Parties shall have no further obligations or liabilities to one another under any of the provisions of the Agreement that are deleted hereby, and release one another from all claims or causes of action that may previously have arisen under any such deleted provision or provisions.
8. JDC Participation Not an Obligation; No Breach. The appointment of any members of the JDC and participation in the JDC at any time after MITSUBISHI obtains Regulatory Approval in Japan is a right of VERTEX and not an obligation. VERTEX will be free to determine whether or not to appoint members to the JDC after MITSUBISHI obtains Regulatory Approval in Japan. If VERTEX does not appoint members of the JDC, it will not be a breach of this Agreement, nor will any consideration be required to be returned; MITSUBISHI will keep VERTEX reasonably informed on a timely basis of its progress and activities as if it were providing such information to the JDC; and any matters that would otherwise be referred to the JDC pursuant to this
5
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Agreement may be referred directly to the Joint Steering Committee pursuant to Section 10.2.1 of the Agreement.
9. Patient Safety. The Parties acknowledge and agree that the Safety Data Exchange Agreement dated July 27, 2007 among the Parties and Janssen Pharmaceutica NV (Safety Data Exchange Agreement), shall remain in full force and effect and that the provisions of this Amendment shall in no way limit the exchange of patient safety information between the Parties.
10. Parallel Importation. The Parties recognize that customers or other Third Parties may import Drug Products purchased in the Territory for use outside the Territory and vice versa. If such activity materially distorts the aggregate relative benefit to the Parties that otherwise would prevail if those Drug Products were sold by VERTEX directly outside the Territory or by MITSUBISHI directly in the Territory, then the Parties shall establish an equitable mechanism to offset the economic effect of any such sales, to the extent it is possible and legally permissible to do so. MITSUBISHI shall use commercially reasonable efforts to take all legally permissible steps necessary to prevent any Drug Product manufactured for sale in the Territory from being distributed or sold outside the Territory. MITSUBISHI shall notify VERTEX if it becomes aware of the exportation of Drug Product from its Territory. VERTEX shall use commercially reasonable efforts to take all legally permissible steps necessary to prevent any Drug Product manufactured for sale in the VERTEX Territory from being distributed or sold in the Territory. VERTEX shall notify MITSUBISHI if it becomes aware of the exportation of Drug Product from VERTEX Territory.
11. [***].
12. [***].
13. Representations and Warranties by VERTEX. VERTEX hereby represents and warrants, in addition to those representations and warranties made in Section 8.1 of the Agreement (which were made as of the Effective Date of the Agreement, and which expressly are not made again effective as of the Amendment Date), that:
(a) Exhibit B accurately sets forth the amount of costs and expenses incurred (with respect to those already actually incurred up to the Cost Measurement Date) and reasonably estimated to be incurred (with respect to those to be incurred on and after the Cost Measurement Date) by or on behalf of VERTEX and/or VERTEX Licensee for the development activities for Combination Therapy with telaprevir in the VERTEX Territory;
(b) all the information disclosed or to be disclosed by VERTEX to MITSUBISHI hereunder relating to the VERTEX Technology is or will be accurate in all material respects and constitutes all material information owned or Controlled by VERTEX with respect to the manufacture of Raw Materials, Drug Substance [***];
(c) the technical support provided or to be provided by VERTEX to MITSUBISHI pursuant to Section 5(c) of this Amendment is all of the support that
6
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
is reasonably necessary to enable MITSUBISHI to exploit the VERTEX Technology in order to manufacture Raw Materials, Drug Substance [***]; and
(d) VERTEX has provided MITSUBISHI with true, complete and correct copies of each of the agreements between VERTEX and any Third Party supplier in the VERTEX supply chain for telaprevir;
(e) as of the Amendment Date, except as disclosed in writing between the Parties, VERTEX is not aware of any issued patents or pending patent applications of a Third Party that, if issued, would be infringed by the manufacture, use and import of Raw Materials, Drug Substance [***].
14. Continuation of the Agreement except as Amended. Except as amended and supplemented hereby, all the other terms and conditions of the Agreement shall remain in full force and effect and shall apply to this Amendment.
[Signature Page Follows]
7
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed and delivered by their duly authorized representatives as of the day and year first written above.
VERTEX PHARMACEUTICALS INCORPORATED
By: |
/s/ Matthew W. Emmens |
|
Name: |
Matthew W. Emmens |
|
Title: |
President, Chairman and CEO |
|
MITSUBISHI TANABE PHARMA CORPORATION
By: |
/s/ Michihiro Tsuchiya |
|
Name: |
Michihiro Tsuchiya |
|
Title: |
President and Representative Director; Chief Executive Officer |
|
Exhibit A: Raw Materials
Exhibit B: Telaprevir Combination Therapy Development Costs in the VERTEX Territory
Exhibit C: Clinical Trials for which Data is to be provided to MITSUBISHI
Exhibit D: Information and Data contained in VERTEX Technology as of Amendment Date
8
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit A: Raw Materials
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit B: Telaprevir Combination Therapy Development Costs in the VERTEX Territory
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit C: Clinical Trials for which Data is to be provided to MITSUBISHI
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit D: List of Information and Data contained in VERTEX Technology as of Amendment Date
[***]
Exhibit 10.3
EXECUTION COPY
Confidential Treatment Requested.
Confidential portions of this document have been redacted and have been
separately filed
with the Commission.
U.S. $155,000,000
VERTEX PHARMACEUTICALS INCORPORATED
SECURED NOTES DUE 2012
NOTE PURCHASE AGREEMENT
September 30, 2009
OLMSTED PARK S.A.
20, rue de la Poste
L-2346 Luxembourg
Attention: Board of Directors
Ladies and Gentlemen:
Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (together with its permitted successors and assigns, the Company), hereby, upon the terms and conditions set forth in this agreement (this Agreement), issues and sells to you (together with your permitted successors and assigns, the Purchaser) U.S. $155,000,000 in aggregate principal amount of its Secured Notes due October 31, 2012 (the Notes). The Notes are to be issued pursuant to an Indenture, dated as of September 30, 2009 (the Indenture), among the Company and U.S. Bank National Association, as trustee (the Trustee). This Agreement is to confirm the agreement concerning the purchase of the Notes from the Company by the Purchaser. Certain capitalized terms used herein are defined in Annex I attached hereto.
The holders of the Notes will also be entitled to the benefit of security interests in the Collateral (as such term is defined in the Security Agreement) (the Collateral) granted under the Security Agreement between the Company and the Trustee, as collateral agent thereunder (the Collateral Agent), dated as of September 30, 2009 (the Security Agreement).
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
2
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
3
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
4
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
5
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
6
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
7
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
8
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
9
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
The Notes will be delivered to the Purchaser against payment by or on behalf of the Purchaser of the purchase price therefor by wire transfer of immediately available funds to an account designated in writing by the Company on the date hereof. The Notes will be evidenced by one or more definitive notes in the form provided for in the Indenture.
10
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
settlement through the Depository Trust Company (DTC). The Company agrees to comply with all the terms and conditions set forth in the representation letters of the Company to DTC relating to the approval of the Notes by DTC for book entry transfer.
(c) The Company agrees not to sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in the Securities Act) that would be integrated with the sale of the Notes in a manner that would require the registration under the Securities Act of the sale to the Purchaser of the Notes.
7. Tax Matters. The Company and the Purchaser agree as follows:
(a) The Purchaser shall indemnify and hold the Company harmless from any Indemnifiable Tax.
(b) The Company agrees to give written notice (the Initial Notice) to the Purchaser of any notice received by the Company which involves the assertion of any claim, or the commencement of any audit, suit, action or proceeding relating to Indemnifiable Tax (an Indemnifiable Tax Claim) within 10 days of such receipt or such earlier time as would allow the Purchaser to timely respond to such Indemnifiable Tax Claim. The Company will give the Purchase such information with respect to the Indemnifiable Tax Claim as the Purchaser may reasonably request. Failure to provide the Purchaser with notice and information with respect to a Indemnifiable Tax Claim within a sufficient period of time and in reasonably sufficient detail to allow the Purchaser to effectively contest such Indemnifiable Tax Claim shall not affect the liability of the Purchaser to the Company except to the extent that the Purchasers position is actually and materially prejudiced as a result thereof.
(c) The Purchaser may, upon written notice to the Company given within 30 days of receipt of the Initial Notice, assume and control the defense of any Indemnifiable Tax Claim at its own cost and expense and with its own counsel and may (i) pursue or forego any and all administrative appeals, proceedings, hearings and conferences with any tax authority, or (ii) either pay (A) the amount of Indemnifiable Taxes claimed and sue for a refund where applicable law permits such refund suits or (B) contest, settle or compromise the Indemnifiable Tax Claim in any permissible manner.
(d) If the Purchaser elects to exercise its right to control the defense of any Indemnifiable Tax Claim pursuant to Section 7(c) of this Agreement, (i) the Company, its employees and its affiliates shall (A) cooperate with the Purchaser in connection with such defense of any Indemnifiable Tax Claim and the pursuit of any related refund, (B) provide the Purchaser (and its employees and other agents) with any applicable powers of attorney reasonably requested and (C) take any actions reasonably requested by the Purchaser, and (ii) the Purchaser shall (A) keep the Company reasonably informed of all material developments and events relating to such Indemnifiable Tax Claim, and permit the Company to participate in (but not to control) the defense any such Indemnifiable Tax Claim (including participation in any relevant meetings and conference calls) at its own cost and expense and with its own counsel.
(e) Any Indemnifiable Tax Claim that the Purchaser does not elect to control pursuant to Section 7(c) of this Agreement shall be controlled by the Company and the Purchaser
11
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
agrees to cooperate with the Company in pursuing such contest, provided, however, that (i) the Company shall keep the Purchaser informed of all material developments and events relating to such Indemnifiable Tax Claim (including promptly forwarding copies to the Purchaser of any related correspondence) and shall use reasonable efforts to provide the Purchaser with an opportunity to review and comment on any material correspondence before the Company sends such correspondence to any tax authority and (ii) the Purchaser, at its own cost and expense and with its own counsel, shall have the right to participate in (including in any relevant meetings and conference calls) the defense of such Indemnifiable Tax Claims.
(f) The Purchaser and the Company further agree to furnish or cause to be furnished to each other, upon request, in a timely manner, such information (including access to books and records) and assistance relating to the Company as is reasonably necessary for the filing of any tax return relating to Indemnifiable Taxes or for the defense of any Indemnifiable Tax Claim.
12
If to the Purchaser to:
Olmsted Park S.A.
20, rue de la Poste
L-2346 Luxembourg
Attention: Board of Directors
with a copy (which shall not constitute notice) to:
Akin Gump Strauss Hauer &
Feld LLP
One Bryant Park
New York, NY 10036
Attention: Stuart E. Leblang
Facsimile: (212) 872-1002
Email: sleblang@akingump.com
If to the Company to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Philippe Tinmouth
Head, Business Development &
Licensing
13
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Facsimile: 617-444-6632
Email: phil_tinmouth@vrtx.com
with a copy (which shall not constitute notice) to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Kenneth S. Boger, Esq.
Senior Vice President and
General Counsel
Facsimile: 617-444-7117
Email: ken_boger@vrtx.com
or to such other address or addresses, facsimile number or numbers or email address or addresses as the Purchaser or the Company may from time to time designate by notice as provided herein, except that notices of such changes shall be effective only upon receipt.
14
Information redacted
pursuant to a confidential treatment request.
An unredacted version
of this exhibit has been filed separately with the Commission.
15
Information redacted
pursuant to a confidential treatment request.
An unredacted version
of this exhibit has been filed separately with the Commission.
16
Information redacted
pursuant to a confidential treatment request.
An unredacted version
of this exhibit has been filed separately with the Commission.
[Signature page follows]
17
If the foregoing correctly sets forth the agreement among the Company and the Purchaser, please indicate your acceptance in the space provided for that purpose below.
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Very truly yours, |
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VERTEX PHARMACEUTICALS |
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INCORPORATED. |
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By: |
/s/ Matthew W. Emmens |
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Name: |
Matthew W. Emmens |
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Title: |
Chairman, President and CEO |
Accepted:
OLMSTED PARK S.A. |
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By: |
/s/ Hille-Paul Schut |
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Name: |
Hille-Paul Schut |
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Title: |
Director |
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By: |
/s/ Julia Vogelweith |
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Name: |
Julia Vogelweith |
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Title: |
Director |
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By: |
/s/ Xavier de Cillia |
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Name: |
Xavier de Cillia |
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Title: |
Director |
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Annex I
Certain Defined Terms
The following terms, as used in this Agreement, shall have the following meanings:
Adverse Effect shall mean (i) an adverse effect on: (a) the legality, validity or enforceability of any of the Transaction Documents, the Janssen Agreement or the security interest granted in the Collateral under the Security Agreement; (b) the amount of the Milestone Payments; or (c) the timing of the payment of the Milestone Payments after achievement of the corresponding Milestone Event; or (ii) a material adverse effect on: (a) the right or ability of the Company (or any permitted successor or assignee) to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder; (b) the rights or remedies of the Purchaser under any of the Transaction Documents; or (c) the right or ability of Janssen (or any permitted successor or assignee) to perform any of its obligations under the Janssen Agreement that are related, directly or indirectly, to the achievement of the Milestone Events.
Affiliate shall mean any Person that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another Person. For purposes of this definition, control (or its derivatives) shall mean the possession, direct or indirect, of the power or ability to direct or cause the direction of the management and policies of a Person, whether through ownership of equity, voting securities or beneficial interest, by contract or otherwise.
Ancillary Janssen Documents means the Global Development Plan, the Supply Agreement and the Pharmacovigilance Agreement as such terms are defined in Sections 1.41, 1.106 and 5.7, respectively, of the Janssen Agreement.
Business Day shall mean any day other than a Saturday, a Sunday, any day that is a legal holiday under the laws of the State of New York, The Commonwealth of Massachusetts or Luxembourg, or any day on which banking institutions located in the State of New York, The Commonwealth of Massachusetts or Luxembourg are authorized or required by law or other governmental action to close.
Commission means the United States Securities and Exchange Commission.
Exchange Act means the United States Securities Exchange Act of 1934, as amended.
Exchange Act Reports shall mean the Companys Annual Report on Form 10-K for the year ended December 31, 2008 as filed with the Commission on February 17, 2009 and all subsequent documents filed with the Commission pursuant to Section 13(a), 13(c) or 15(d) of the Exchange Act on or prior to the date hereof.
GAAP means generally accepted accounting principles in the United States of America as in effect from time to time, including those set forth in (1) the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and (2) the statements and pronouncements of the Financial Accounting Standards Board.
A-1
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Governmental Authority shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign).
Indemnifiable Tax shall mean any United States federal, state of local withholding tax (including interest and penalties thereon) that, pursuant to a final administrative decision, a judicial decision or an agreement by the Purchaser pursuant to Section 7(c) or the Company pursuant to Section 7(e), is determined to be payable by the Company as a result of its failure to withhold from payments on the Notes.
Indemnifiable Tax Claim shall have the meaning set forth in Section 7(b).
Initial Notice shall have the meaning set forth in Section 7(b).
Janssen shall mean Janssen Pharmaceutica, N.V., a Belgium corporation, including its successors and assigns.
Janssen Agreement shall mean the License, Development, Manufacturing and Commercialization Agreement by and between the Company and Janssen effective as of June 30, 2006, as such agreement is amended and in effect on the date hereof, together with the Janssen Consent and the Ancillary Janssen Documents, as each may be amended and/or restated from time to time after the date hereof in accordance with the terms of the Indenture and any new, substitute or amended agreement by and between the Company and Janssen relating to the Milestone Payments made after the date hereof in accordance with the terms of the Indenture.
Janssen Consent shall have the meaning set forth in Section 2(k).
Knowledge shall mean, with respect to the Company, the knowledge of any of the following officers or employees of the Company: the Chief Executive Officer; the Chief Medical Officer; the General Counsel; the Chief Scientific Officer; the Chief Financial Officer; the Chief Commercial Officer; the Vice President and Corporate Controller; the Head, Business Development & Licensing; and the Deputy General Counsel. An individual will be deemed to have knowledge of a particular fact or other matter if (i) such individual has or at any time had actual knowledge of such fact or other matter or (ii) a prudent individual would be expected to discover or otherwise become aware of such fact or other matter in the course of his or her responsibilities in his or her capacity as an officer or employee of the Company or in the course of conducting a reasonably diligent review concerning the existence thereof with any employee of the Company or any of its Subsidiaries who, as of the date of this Agreement, reports directly to such individual and who (x) has responsibilities or (y) would reasonably be expected to have actual knowledge of circumstances or other information, in each case, that would reasonably be expected to be pertinent to such fact or other matter. Notwithstanding anything in this definition to the contrary, the Company will be deemed to have knowledge of any fact or matter that is the subject of, or referred to within, any written notice it or any of its Subsidiaries has received (whether in hard copy, digital or electronic format).
Lien shall mean any lien, hypothecation, charge, instrument, license, preference, priority, security agreement, security interest, mortgage, option, right of first refusal, privilege, pledge,
I-2
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
liability, covenant or order, or any encumbrance, restriction, right or claim of any other Person or Governmental Authority of any kind whatsoever, whether choate or inchoate, filed or unfiled, noticed or unnoticed, recorded or unrecorded, contingent or non-contingent, material or non-material, known or unknown, other than any of the above created solely in favor of the Purchaser by the Transaction Documents.
[***].
[***].
[***].
[***].
Milestone Payments shall mean collectively [***]; (ii) (a) all additional amounts added to any of the milestone payments described above in clauses (i)(a) and (b) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payments described above in clauses (i)(a) and (b) pursuant to Section 9.10 of the Janssen Agreement and (b) the Purchasers Pro Rata Portion of all additional amounts added to the milestone payment described above in clause (i)(c) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payment described above in clause (i)(c) pursuant to Section 9.10 of the Janssen Agreement; (iii) all accounts (as defined under the UCC) evidencing the rights to the payments and amounts described in clauses (i) and (ii) above; and (iv) all proceeds (as defined under the UCC) of the foregoing.
Person shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization of any kind, but not including a Governmental Authority.
Pledged Interest shall mean collectively (i) an undivided 100% interest in the right to receive the Milestone Payments and (ii) the right to enforce directly against Janssen the right to payment of all or any portion of the Milestone Payments represented by the Pledged Interest when earned upon achievement of the Milestone Events pursuant to the Janssen Agreement.
Prohibited Amendment shall mean any amendment, modification, restatement or supplement of any provision of the Janssen Agreement that changes in any way (i) the event underlying any of the Milestone Events, (ii) the amount of any of the Milestone Payments or (iii) the timing of the payment of any of the Milestone Payments by Janssen after achievement of the applicable Milestone Event by Janssen. For avoidance of doubt, any termination of the Janssen Agreement shall not be deemed a Prohibited Amendment.
Pro Rata Portion shall mean, with respect to the Purchaser, [***] and, with respect to the Company, [***].
Purchaser shall have the meaning set forth in the preamble and shall include its successors and assigns.
I-3
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Set-off shall mean any set-off, rescission, counterclaim, defense, reduction or deduction of any kind. Without limiting the generality of the foregoing, the term Set-off shall include the right by Janssen to reduce the amount of any of the Milestone Payments for any reason, including without limitation in connection with (i) a breach by the Company of the Janssen Agreement, (ii) any anti stacking or similar rights with respect to payments to third parties for access to intellectual property rights or data, (iii) any discounted payment obligations in connection with third party sales of generic competitive products, (iv) any rights to credit against any payment obligations any costs, expenses or liabilities of Janssen under the Janssen Agreement, including with respect to (A) Global Development Costs (as defined in the Janssen Agreement), (B) any costs and expenses of patent prosecution, maintenance or enforcement, or (C) defense of third party infringement claims, or (v) any amounts paid or payable pursuant to any indemnification rights or obligations of the Company or Janssen under the Janssen Agreement.
Subsidiary or Subsidiaries shall mean with respect to any Person (i) any corporation of which the outstanding capital stock having at least a majority of votes entitled to be cast in the election of directors (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time be owned, directly or indirectly, by such Person or by another subsidiary of such Person or (ii) any other Person of which at least a majority voting interest (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time owned, directly or indirectly, by such Person or by another subsidiary of such Person.
Survival Date shall have the meaning set forth in Section 11.
Transaction Documents shall mean, collectively, the Notes, this Agreement, the Indenture and the Security Agreement.
UCC shall mean the Uniform Commercial Code as in effect from time to time in the State of New York; provided, however, that, if, with respect to any financing statement or by reason of any provisions of law, the perfection or the effect of perfection or non-perfection of the Purchasers security interests in the Pledged Interest pursuant to the Security Agreement, is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then UCC shall mean the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
I-4
Exhibit 10.4
EXECUTION COPY
Confidential Treatment Requested.
Confidential portions of this document have been redacted
and have been separately filed
with the Commission.
SECURITY AGREEMENT
Dated as of September 30, 2009
between
VERTEX PHARMACEUTICALS INCORPORATED
and
U.S. BANK NATIONAL ASSOCIATION,
as Collateral Agent
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
TABLE OF CONTENTS
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ARTICLE I DEFINITIONS |
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Section 1.01 |
Definition of Terms Used Herein |
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Section 1.02 |
Definition of Certain Terms Used Herein |
2 |
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Section 1.03 |
Rules of Interpretation |
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ARTICLE II SECURITY INTEREST |
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Section 2.01 |
Security Interest |
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Section 2.02 |
No Assumption of Liability |
5 |
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ARTICLE III REPRESENTATIONS AND WARRANTIES |
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Section 3.01 |
Title and Authority |
5 |
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Section 3.02 |
Filings |
5 |
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Section 3.03 |
Validity and Perfection of Security Interest |
5 |
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Section 3.04 |
Absence of Other Liens |
5 |
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Section 3.05 |
UCC Representations and Warranties |
5 |
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ARTICLE IV COVENANTS |
6 |
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Section 4.01 |
Change of Name; Location of Collateral; Records; Place of Business |
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Section 4.02 |
Creation and Perfection of Liens Securing Collateral; Further Assurances |
6 |
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Section 4.03 |
Taxes; Encumbrances |
7 |
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Section 4.04 |
Assignment of Security Interest in Milestone Payments |
7 |
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Section 4.05 |
Limitation on Disposition of Collateral and Liens on Collateral |
7 |
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Section 4.06 |
Marking of Books and Records |
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ARTICLE V PAYMENTS |
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Section 5.01 |
Payment Direction; Payment Account |
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Section 5.02 |
Power of Attorney |
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ARTICLE VI REMEDIES |
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Section 6.01 |
Remedies Upon Default |
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Section 6.02 |
Application of Proceeds |
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ARTICLE VII MISCELLANEOUS |
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Section 7.01 |
Notices |
11 |
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Section 7.02 |
Security Interest Absolute |
12 |
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Section 7.03 |
Survival of Agreement |
12 |
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Section 7.04 |
Binding Effect |
12 |
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Section 7.05 |
Successors and Assigns |
12 |
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Section 7.06 |
Collateral Agents Fees and Expenses; Indemnification |
12 |
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Section 7.07 |
GOVERNING LAW |
13 |
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Section 7.08 |
Waivers; Amendment |
13 |
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i
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.09 |
WAIVER OF JURY TRIAL |
14 |
Section 7.10 |
Severability |
14 |
Section 7.11 |
Entire Agreement |
14 |
Section 7.12 |
Counterparts |
14 |
Section 7.13 |
Jurisdiction |
14 |
Section 7.14 |
Termination |
15 |
Section 7.15 |
Headings and Recitals |
15 |
Section 7.16 |
Limitation on Duties of Collateral Agent |
15 |
Exhibits:
Exhibit A: Payment Direction
Schedules:
Schedule 3.05: UCC Representations and Warranties
Schedule 5.01(c): Trustee Account Information
ii
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
SECURITY AGREEMENT (this Agreement) dated as of September 30, 2009, between VERTEX PHARMACEUTICALS INCORPORATED (the Company or the Grantor), a Massachusetts corporation, and U.S. Bank National Association, having its principal corporate trust office at One Federal Street, Boston, Massachusetts 02110 (together with any successor or successors in such capacity, the Collateral Agent) for the benefit of the Trustee (as defined below) and the Holders (as defined below).
Reference is made to the Secured Notes due 2012 of the Company (as amended, restated, supplemented or modified from time to time, the Notes), in the original aggregate principal amount at maturity of $155,000,000 issued pursuant to the Indenture, dated as of September 30, 2009 (as amended, restated, amended and restated, modified or supplemented from time to time and including any agreement extending the maturity of, refinancing or otherwise amending, amending and restating or otherwise modifying or restructuring all or any portion of the obligations of the Company under the Notes or such agreement or any successor agreement, the Indenture) among the Company, the Collateral Agent and U.S. Bank National Association, as trustee (together with any successor or successors in such capacity, the Trustee).
The Company will materially benefit from the issuance of the Notes and it is a condition to the issuance of the Notes that the Company execute and deliver this Agreement.
The Indenture requires the Company to secure its obligations under the Notes and the Indenture by a first priority security interest in the Collateral (as hereinafter defined).
Accordingly, the Company and the Collateral Agent, on behalf of itself and each Secured Party (and each of their respective successors or assigns), hereby agree as follows:
Section 1.01 Definition of Terms Used Herein
Unless the context otherwise requires, all capitalized terms used but not defined herein shall have the meanings set forth in the Indenture, all references to the Uniform Commercial Code or UCC shall mean the Uniform Commercial Code in effect in the State of New York as of the date hereof and any uncapitalized terms used herein which are defined in the UCC have the respective meanings provided in the UCC; provided, however, that if a term is defined in Article 9 of the Uniform Commercial Code differently than in another Article thereof, the term shall have the meaning set forth in Article 9, and provided, further, that if by reason of mandatory provisions of law, perfection, or the effect of perfection or non-perfection, of the Security Interest in any Collateral or the availability of any remedy hereunder is governed by the Uniform Commercial Code as in effect in a jurisdiction other than New York, Uniform Commercial Code or UCC means the Uniform Commercial Code as in effect in such other jurisdiction for purposes of the provisions hereof relating to such perfection or effect of perfection or non-perfection or availability of such remedy, as the case may be.
1
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 1.02 Definition of Certain Terms Used Herein
As used herein, the following terms shall have the following meanings:
Accounts shall mean accounts as defined in the UCC, and all right, title and interest of the Grantor to payment for goods and services sold or leased, including any such right evidenced by Chattel Paper, whether due or to become due, whether or not it has been earned by performance, and whether now or hereafter acquired or arising in the future.
Bankruptcy Code shall mean the United States Bankruptcy Code, 11 U.S.C. Section 101 et seq., as amended from time to time.
Books and Records shall mean all instruments, files, records, ledger sheets and documents covering or relating to any of the Collateral.
Chattel Paper shall have the meaning given that term in the UCC.
Collateral shall mean (i) the Pledged Interest and (ii) any and all Proceeds of the Pledged Interest.
Debtor Relief Laws shall mean the Bankruptcy Code, and all other liquidation, conservatorship, bankruptcy, assignment for the benefit of creditors, moratorium, rearrangement, receivership, insolvency, reorganization, or similar debtor relief Laws of the United States or other applicable jurisdictions from time to time in effect and affecting the rights of creditors generally.
Documents shall have the meaning given that term in the UCC.
Financing Statement shall have the meaning given that term in the UCC.
General Intangibles shall mean general intangibles as defined in the UCC.
Governmental Authority shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign).
Holders shall mean the holders from time to time of the Notes.
Indemnitee shall have the meaning given that term in Section 7.06(b) of this Agreement.
Indenture shall have the meaning given to that term in the preliminary statement of this Agreement.
Instruments shall have the meaning given that term in the UCC.
Janssen shall mean Janssen Pharmaceutica, N.V., a Belgium corporation, including its successors and assigns.
2
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Janssen Agreement shall mean the License, Development, Manufacturing and Commercialization Agreement by and between the Grantor and Janssen effective as of June 30, 2006, as such agreement is amended and in effect on the date hereof, together with the Janssen Consent, as each may be amended and/or restated from time to time after the date hereof in accordance with the terms of the Indenture and any new, substitute or amended agreement by and between the Grantor and Janssen relating to the Milestone Payments to be made after the date hereof in accordance with the terms of the Indenture.
Janssen Consent shall have the meaning given that term in Section 2(k) of the Note Purchase Agreement.
Laws shall mean, collectively, all international, foreign, Federal, state and local statutes, treaties, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities, including the interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directives, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority, in each case whether or not having the force of law.
[***].
[***].
[***].
[***].
Milestone Payments shall mean collectively [***] and (ii) (a) all additional amounts added to any of the milestone payments described above in clauses (i)(a) and (b) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payments described above in clauses (i)(a) and (b) pursuant to Section 9.10 of the Janssen Agreement and (b) the Collateral Agents Pro Rata Portion of all additional amounts added to the milestone payment described above in clause (i)(c) under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the milestone payment described above in clause (i)(c) pursuant to Section 9.10 of the Janssen Agreement.
Note Documents shall mean the Indenture, the Notes and the Collateral Documents, in each case including all exhibits and schedules thereto, and all other agreements, documents and instruments relating to the Notes, in each case as the same may be amended, modified or supplemented from time to time in accordance with the provisions thereof.
Obligations shall mean the Note Obligations (as defined in the Indenture).
Payment Account shall have the meaning given that term in Section 5.01(c).
Payment Direction shall have the meaning given that term in Section 5.01(a).
3
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Payment Intangible shall have the meaning given that term in the UCC.
Person shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization of any kind, including a Governmental Authority.
Pledged Interest shall mean collectively (i) an undivided 100% interest in the right to receive the Milestone Payments and (ii) the right to enforce directly against Janssen the right to payment of all or any portion of the Milestone Payments represented by the Pledged Interest when earned upon achievement of the Milestone Events pursuant to the Janssen Agreement.
Proceeds shall mean proceeds as defined in the UCC.
Pro Rata Portion shall mean, with respect to the Collateral Agent[***] and, with respect to the Grantor[***].
Secured Parties shall mean
Security Interest shall have the meaning given that term in Section 2.01.
Section 1.03 Rules of Interpretation The rules of interpretation specified in Section 1.03 of the Indenture shall be applicable to this Agreement.
Section 2.01 Security Interest As security for the payment or performance, as the case may be, in full of the Obligations, the Grantor hereby pledges to the Collateral Agent, its successors and assigns, for the ratable benefit of the Secured Parties, and hereby grants to the Collateral Agent, its successors and assigns, for the ratable benefit of the Secured Parties, a security interest in, all of the Grantors right, title and interest in, to and under the Collateral (the Security Interest). Without limiting the foregoing, the Grantor hereby designates the Collateral Agent as the Grantors true and lawful attorney, exercisable by the Collateral Agent or its nominee or custodian whether or not an Event of Default exists, with full power of substitution, at the Collateral Agents option, to file one or more Financing Statements and continuation statements as it determines reasonably necessary for the purpose of perfecting, confirming, continuing, enforcing or protecting the Security Interest granted by the Grantor, without the signature of the Grantor (the Grantor hereby appointing the Collateral Agent as its attorney to sign its name to any such Financing Statement or continuation statement, whether or not an
4
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Event of Default exists), and naming the Grantor as debtor and the Collateral Agent as secured party.
Section 2.02 No Assumption of Liability No Assumption of Liability. The Security Interest is granted as security only and shall not subject the Collateral Agent or any other Secured Party to, or in any way alter or modify, any obligation or liability of the Grantor with respect to or arising out of the Collateral.
The Grantor represents and warrants to the Collateral Agent and the Secured Parties, as of the date of this Agreement, that:
Section 3.01 Title and Authority The Grantor has good and valid rights in and title to the Collateral and has full power and authority to grant to the Collateral Agent the Security Interest in such Collateral pursuant hereto and to execute, deliver and perform its obligations in accordance with the terms of this Agreement, without the consent or approval of any other Person other than any consent or approval which has been obtained and is in full force and effect.
Section 3.02 Filings A Financing Statement or other appropriate filings, recordings or registrations containing a description of the Collateral have been delivered to the Collateral Agent or its nominee or custodian for filing in the central-filing office specified in Schedule 3.05 hereto, which Financing Statement constitutes all the filings and recordings that are necessary to establish a legal, valid and perfected security interest in favor of the Collateral Agent (for the ratable benefit of the Secured Parties) in respect of all Collateral in which the security interest may be perfected by filing or recording, and no further or subsequent filing, refiling, recording or rerecording is necessary, except as provided under applicable law.
Section 3.03 Validity and Perfection of Security Interest The Security Interest constitutes a legal and valid Lien (prior and superior in right and interest to any other Person) in all the Collateral securing the payment and performance of the Obligations, and, subject to the filings described in Section 3.02 above, a perfected Lien (prior and superior in right and interest to any other Person) in all Collateral in which a security interest may be perfected by filing or recording a Financing Statement or analogous document pursuant to the Uniform Commercial Code or other applicable Law. No amounts payable under or in connection with the Collateral are evidenced by any Instrument or Chattel Paper.
Section 3.04 Absence of Other Liens To the extent that the Collateral currently exists, the Collateral is owned by the Grantor free and clear of any Lien. The Grantor has not filed or consented to the filing of any Financing Statement or analogous document under the Uniform Commercial Code or any other applicable laws covering any Collateral.
Section 3.05 UCC Representations and Warranties The Grantors exact legal name is, and for the immediately preceding ten (10) years has been, Vertex Pharmaceuticals Incorporated. The principal place of business and chief executive office of the Grantor for the
5
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
immediately preceding ten (10) years and the office where it keeps its books and records relating to the Collateral are located at the address(es) set forth on Schedule 3.05 attached hereto. The Grantors Massachusetts organizational identification number and Federal Employer Identification Number are as set forth on Schedule 3.05 attached hereto.
ARTICLE
IV
COVENANTS
Section 4.01 Change of Name; Location of Collateral; Records; Place of Business
(a) The Grantor agrees to furnish to the Collateral Agent at least thirty (30) days (or such shorter period of time as may be agreed to by the Collateral Agent) prior written notice of any change (i) in its name, (ii) in its organizational structure (including its status as a corporation incorporated under the laws of The Commonwealth of Massachusetts) or (iii) in its Federal Taxpayer Identification Number or state organizational number. The Grantor agrees not to effect or permit any change referred to above in this Section 4.01 unless all filings have been made under the Uniform Commercial Code or otherwise that are required or advisable in order for the Collateral Agent to continue at all times following such change to have a valid, legal and perfected Lien (prior and superior in right and interest to any other Person) in all the Collateral.
(b) The Grantor agrees to maintain, at its own cost and expense, such complete and accurate records with respect to the Collateral as is consistent with its current practices and in accordance with such prudent and standard practices used in industries that are the same as or similar to those in which the Grantor is engaged, but in any event to include complete accounting records with respect to any part of the Collateral.
Section 4.02 Creation and Perfection of Liens Securing Collateral; Further Assurances
(a) On or prior to the date of this Agreement, the Grantor shall have granted, created and perfected the security interests and other Liens created or intended to be created pursuant to this Agreement in the Collateral in favor of the Collateral Agent.
(b) The Grantor shall, and shall cause each of the Guarantors to, execute any and all further documents, Financing Statements, agreements and instruments, and take all further action that may be required under applicable law, or that the Collateral Agent may reasonably request, in order to grant, create, preserve, enforce, protect and perfect the validity and priority of the security interests and other Liens created by this Agreement in the Collateral.
(c) The Grantor shall, and shall cause each of the Guarantors to, do or cause to be done all acts and things that may be required, or that the Collateral Agent from time to time may reasonably request, to assure and confirm that the Collateral Agent holds, for the benefit of the Secured Parties, duly created and enforceable and perfected Liens upon the Collateral (including any property or assets that are acquired or otherwise become Collateral after the date of this Agreement), in each case, as contemplated by, and with the lien priority required under, this Agreement.
6
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
(d) Upon request of the Collateral Agent at any time after an Event of Default has occurred and is continuing, the Grantor shall, and shall cause each of the Guarantors to, and shall cause the Subsidiaries to, (i) permit the Collateral Agent or any advisor, auditor, consultant, attorney or representative acting for the Collateral Agent, upon reasonable notice to the Grantor and during normal business hours, to make extracts from and copy the books and records of the Grantor and its Subsidiaries relating to the Collateral, and to discuss any matter pertaining to the Collateral with the officers and employees of the Grantor and its Subsidiaries, and (ii) deliver to the Collateral Agent such reports relating to any such property or any Lien thereon as the Collateral Agent may reasonably request. The Grantor shall promptly reimburse the Collateral Agent for all reasonable costs and expenses incurred by the Collateral Agent in connection therewith, including all reasonable fees and charges of any advisors, auditors, consultants, attorneys or representatives acting for the Collateral Agent.
(e) The provisions of this Section 4.02 shall apply only to the security interests and other Liens on the Collateral in favor of the Collateral Agent, and shall not impose or be interpreted as imposing any duty on the Grantor or any Guarantor to act in a manner that preserves the Collateral (including without limitation Janssens obligation to make the Milestone Payments or the amount of any Milestone Payment or the date on which a Milestone Payment is due) or to refrain from acting in a manner that adversely impacts the Collateral (including without limitation Janssens obligation to make the Milestone Payments or the amount of any Milestone Payment or the date on which a Milestone Payment is due); provided, however, that the foregoing provisions of this sentence shall not limit the Grantors obligations under Section 4.12 of the Indenture.
Section 4.03 Taxes; Encumbrances At its option, the Collateral Agent may discharge past due taxes, assessments, charges, fees, Liens, security interests or other encumbrances at any time levied or placed on the Collateral and which the Grantor is not diligently contesting by appropriate proceedings or actions, and may pay for the preservation of the Collateral to the extent the Grantor fails to do so as required by the Indenture or this Agreement, and the Grantor agrees to reimburse the Collateral Agent on demand for any payment made or any expense reasonably incurred by the Collateral Agent pursuant to the foregoing authorization; provided, however, that nothing in this Section 4.03 shall be interpreted as excusing the Grantor from the performance of, or imposing any obligation on the Collateral Agent or any Secured Party to cure or perform, any covenants or other promises of the Grantor with respect to taxes, assessments, charges, fees, Liens, security interests or other encumbrances and preservation as set forth herein or in the other Note Documents.
Section 4.04 Assignment of Security Interest in Milestone Payments If at any time the Grantor shall take a security interest in any property of Janssen or any other Person to secure payment and performance of a Milestone Payment or otherwise in respect of the Milestone Payments, the Grantor shall promptly assign such security interest to the Collateral Agent.
Section 4.05 Limitation on Disposition of Collateral and Liens on Collateral The Grantor shall not (i) directly or indirectly, sell, transfer, assign, lease, license, sublicense, convey or otherwise directly or indirectly dispose of any of the Collateral or any interest therein or (ii) except for the Security Interest in the Collateral granted to the Collateral
7
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Agent for the benefit of the Secured Parties by this Agreement, cause or suffer to exist or become effective any Lien of any kind on or with respect to any of the Collateral or any interest therein, or, in each case, enter into any agreement to do any of the foregoing, provided, however, that in no event shall the termination of the Janssen Agreement for any reason be a violation or breach of this Section 4.05 or any other term of this Agreement or the Indenture.
Section 4.06 Marking of Books and Records To the extent that the Collateral Agent may reasonably request, in order to perfect the Security Interest or to enable the Collateral Agent to exercise its rights and remedies hereunder, the Grantor shall mark its Books and Records relating to the Collateral and documents evidencing or pertaining thereto with an appropriate reference to the fact that the Milestone Payments have been assigned to the Collateral Agent for the benefit of the Secured Parties and that the Collateral Agent has a security interest therein.
8
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.02 Power of Attorney The Grantor irrevocably makes, constitutes and appoints the Collateral Agent (and all officers, employees or agents designated by the Collateral Agent) as such Grantors true and lawful agent and attorney-in-fact, and in such capacity the Collateral Agent shall have the right, with power of substitution for the Grantor and in the Grantors name or otherwise, for the use and benefit of the Collateral Agent and the Secured Parties, (i) at any time, whether or not a Default or Event of Default has occurred, to take actions required to be taken by the Grantor under Section 2.01 of this Agreement, (ii) upon the occurrence and during the continuance of an Event of Default, (A) to receive, endorse, assign and/or deliver any and all notes, acceptances, checks, drafts, money orders or other evidences of payment comprising or evidencing the Collateral or any part thereof; (B) to demand, collect, receive payment of, give receipt for and give discharges and releases of all or any of the Collateral; (C) to sign the name of the Grantor on any proof of claim in bankruptcy against Janssen; (D) to commence and prosecute any and all suits, actions or proceedings at law or in equity in any court of competent jurisdiction to collect or otherwise realize on all or any of the Collateral; and (E) to sell, assign, transfer, pledge, make any agreement with respect to or otherwise deal with all or any of the Collateral, as fully and completely as though the Collateral Agent were the absolute owner of the Collateral for all purposes, and (iii) to notify or to require the Grantor to notify Janssen to make payment directly to the Collateral Agent (or its nominee or custodian) in a manner other than as specified in the Payment Direction; provided, however, that nothing herein contained shall be construed as requiring or obligating the Collateral Agent or any Secured Party to make any inquiry as to the nature or sufficiency of any payment received by the Collateral Agent or any Secured Party, or to present or file any claim or notice, or to take any action with respect to the Collateral or any part thereof or the moneys due or to become due in respect thereof or any property covered thereby, and no action taken or omitted to be taken by the Collateral Agent or any Secured Party with respect to the Collateral or any part thereof shall give rise to any defense, counterclaim or offset in favor of the Grantor or to any claim or action against the Collateral Agent or any Secured Party other than arising out of the gross negligence or willful misconduct of the Collateral Agent or any such Secured Party (as determined by a court of competent jurisdiction by a final and nonappealable judgment); and provided, further, however, that nothing contained in this Section 5.02 shall entitle the Collateral Agent or any of the Secured Parties to the rights of Grantor under the Janssen Agreement other than the right to payment of the Collateral. It is understood and agreed that the appointment of the Collateral Agent as the agent and attorney-in-fact of the Grantor for the purposes set forth above is coupled with an interest and is irrevocable. The provisions of this Section shall in no event relieve the
9
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Grantor of any of its obligations hereunder or under any other Note Document with respect to the Collateral or any part thereof or impose any obligation on the Collateral Agent or any Secured Party to proceed in any particular manner with respect to the Collateral or any part thereof, or in any way limit the exercise by the Collateral Agent or any Secured Party of any other or further right which it may have on the date of this Agreement or hereafter, whether hereunder, under any other Note Document, by law or otherwise.
Section 6.01 Remedies Upon Default Upon the occurrence and during the continuance of an Event of Default, it is agreed that the Collateral Agent shall have in any jurisdiction in which enforcement hereof is sought, in addition to all other rights and remedies, the rights and remedies of a secured party under the UCC (whether or not in effect in the jurisdiction where such rights are exercised) or other applicable Law. The rights and remedies of the Collateral Agent shall include, without limitation, the right to take any or all of the following actions at the same or different times:
10
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 6.02 Application of Proceeds After the occurrence and during the continuance of an Event of Default, the Collateral Agent shall apply the proceeds of any collection or sale of the Collateral, as well as any Collateral consisting of cash, in accordance with the provisions of Section 6.10 of the Indenture.
Section 7.01 Notices All communications and notices hereunder shall (except as otherwise expressly permitted herein) be in writing and given as provided in Section 13.02 of the Indenture.
11
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.02 Security Interest Absolute All rights of the Collateral Agent hereunder, the Security Interest and all obligations of the Grantor hereunder shall be absolute and unconditional irrespective of (i) any lack of validity or enforceability of the Indenture, any other Note Document, any agreement with respect to any of the Obligations or any other agreement or instrument relating to any of the foregoing, (ii) any change in the time, manner or place of payment of, or in any other term of, all or any of the Obligations, or any other amendment or waiver of or any consent to any departure from the Indenture, any other Note Document or any other agreement or instrument, (iii) any exchange, release or non-perfection of any Lien on other collateral, or any release or amendment or waiver of or consent under or departure from any guarantee, securing or guaranteeing all or any of the Obligations, (iv) the existence of any claim, set-off or other right which the Grantor may have at any time against the Collateral Agent, any other Secured Party, or any other Person, whether in connection herewith or any unrelated transaction; provided, that nothing herein shall prevent the assertion of any such claim by separate suit or compulsory counterclaim or (v) any other circumstance that might otherwise constitute a defense available to, or a discharge of, the Grantor in respect of the Obligations or this Agreement.
Section 7.03 Survival of Agreement All covenants, agreements, representations and warranties made by the Grantor herein and in the certificates or other instruments prepared or delivered in connection with or pursuant to this Agreement shall be considered to have been relied upon by the Holders or other Secured Parties and shall survive the issuance of the Notes, regardless of any investigation made by any of the Holders or on their behalf, and shall continue in full force and effect until this Agreement shall terminate.
Section 7.04 Binding Effect This Agreement shall become effective as to the Grantor when a counterpart hereof executed on behalf of the Grantor shall have been delivered to the Collateral Agent and a counterpart hereof shall have been executed on behalf of the Collateral Agent, and thereafter shall be binding upon the Grantor and the Collateral Agent and their respective successors and assigns, and shall inure to the benefit of the Grantor, the Collateral Agent and the other Secured Parties and their respective successors and assigns, except that the Grantor shall not have the right to assign or transfer its rights or obligations hereunder or any interest herein or in the Collateral (and any such assignment or transfer shall be void) except as expressly contemplated by this Agreement or the Indenture.
Section 7.05 Successors and Assigns Whenever in this Agreement any of the parties hereto is referred to, such reference shall be deemed to include the successors and assigns of such party; and all covenants, promises and agreements by or on behalf of the Grantor or the Collateral Agent that are contained in this Agreement shall bind and inure to the benefit of their respective successors and assigns.
12
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.07 GOVERNING LAW THIS AGREEMENT SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH AND GOVERNED BY THE LAW OF THE STATE OF NEW YORK (EXCEPT FOR THE CONFLICT OF LAWS RULES THEREOF, BUT INCLUDING GENERAL OBLIGATIONS LAW SECTIONS 5-1401 AND 5-1402).
Section 7.08 Waivers; Amendment (a) No failure or delay of the Collateral Agent in exercising any power or right hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right or power, or any abandonment or discontinuance of steps to enforce such a right or power, preclude any other or further exercise thereof or the exercise of any other right or power. The rights and remedies of the Collateral Agent hereunder and of the Collateral Agent, the Trustee, the Holders and the other Secured Parties under the other Note Documents are cumulative and are not exclusive of any rights or remedies that they would otherwise have. No waiver of any provisions of this Agreement, the Indenture or any other Note Document or consent to any departure by the Grantor therefrom shall in any event be effective unless the same shall be permitted by paragraph (b) below, and then such waiver or consent shall be effective only in the specific instance and for the purpose for which given. No notice to or demand on the Grantor in any case shall entitle the Grantor to any other or further notice or demand in similar or other circumstances.
13
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.09 WAIVER OF JURY TRIAL EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING IN WHICH THE GRANTOR AND THE COLLATERAL AGENT ARE PARTIES AND WHICH, DIRECTLY OR INDIRECTLY, ARISES OUT OF OR RELATES TO THIS AGREEMENT, ANY OTHER NOTE DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.
Section 7.10 Severability In the event any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby (it being understood that the invalidity of a particular provision in a particular jurisdiction shall not in and of itself affect the validity of such provision in any other jurisdiction). The parties shall endeavor in good faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.
Section 7.11 Entire Agreement This Agreement, together with the Exhibits hereto (which are incorporated herein by reference), and the other Transaction Documents constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior agreements, understandings and negotiations, both written and oral, between the parties hereto with respect to the subject matter of this Agreement. No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Exhibits or other Transaction Documents) has been made or relied upon by either party hereto. Neither this Agreement, nor any provision hereof, is intended to confer upon any Person other than the parties hereto and the Secured Parties any rights or remedies hereunder.
Section 7.12 Counterparts This Agreement may be executed in two or more counterparts, each of which shall constitute an original but all of which when taken together shall constitute but one contract, and shall become effective as provided in Section 7.04. Delivery of an executed signature page to this Agreement by facsimile transmission shall be effective as delivery of a manually executed counterpart hereof.
Section 7.13 Jurisdiction (a) The Grantor hereby irrevocably and unconditionally submits, for itself and its property, to the nonexclusive jurisdiction of the Supreme Court of the State of New York sitting in New York County and of the United States District Court of the Southern District of New York, and any appellate court from any thereof, in
14
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
any action or proceeding arising out of or relating to this Agreement, or for recognition or enforcement of any judgment, and each of the parties hereto hereby irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding may be heard and determined in such New York State court or, to the extent permitted by law, in such Federal court. Each of the parties hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law. Nothing in this Agreement shall affect any right that the Collateral Agent, the Trustee, any Holder or any other Secured Party may otherwise have to bring any action or proceeding relating to this Agreement, the Indenture or any other Note Document against the Grantor or its properties in the courts of any jurisdiction.
Section 7.14 Termination This Agreement and the Security Interest shall terminate when all the Obligations have been indefeasibly paid in full in accordance with the terms and conditions of the Indenture (other than contingent indemnification obligations with respect to then unasserted claims which, pursuant to the terms of this Agreement or the other Note Documents survive the termination of this Agreement or the other Note Documents), at which time the Collateral Agent shall promptly deliver to the Grantor written authority to terminate, at the Grantors request and expense, all Financing Statements and similar documents which the Grantor shall reasonably request to evidence such termination. Any execution and delivery of termination statements or documents pursuant to this Section 7.14 shall be without recourse to or warranty by the Collateral Agent.
Section 7.15 Headings and Recitals The recitals at the beginning of this Agreement and the headings of the sections and subsections hereof are provided for convenience only and shall not be construed as representations made by the Grantor, and shall not in any way affect the meaning or construction of any provision of this Agreement.
Section 7.16 Limitation on Duties of Collateral Agent Beyond the exercise of reasonable care in the custody and preservation thereof, the Collateral Agent will not have any duty as to any Collateral in its possession or control or in the possession or control of any sub agent or bailee or any income therefrom or as to the preservation of rights against prior parties or any other rights pertaining thereto. The Collateral Agent will be deemed to have exercised reasonable care in the custody and preservation of the Collateral in its possession or control if such Collateral is accorded treatment substantially equal to that which it accords its own property, and will not be liable or responsible for any loss or damage to any Collateral, or for any diminution in the value thereof, by reason of any act or omission of any sub agent or bailee selected by the Collateral Agent in good faith or by reason of any act or omission such sub-agent or bailee selected by the Collateral Agent pursuant to instructions from the Collateral Agent, except to the extent that such liability arises from the Collateral Agents gross negligence, bad
15
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
faith or willful misconduct. The Collateral Agent shall not be responsible for the existence, genuineness or value of any of the Collateral or for the validity, perfection, priority or enforceability of the Liens in any of the Collateral, whether impaired by operation of law or by reason of any action or omission to act on its part hereunder, except to the extent such action or omission constitutes gross negligence, bad faith or willful misconduct on the part of the Collateral Agent, for the validity or sufficiency of the Collateral or any agreement or assignment contained therein, for the validity of the title of the Company to the Collateral, for insuring the Collateral or for the payment of taxes, charges, assessments or Liens upon the Collateral or otherwise as to the maintenance of the Collateral.
[Signature page follows.]
16
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the day and year first above written.
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VERTEX PHARMACEUTICALS |
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INCORPORATED |
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By: |
/s/ Matthew W. Emmens |
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Name: |
Matthew W. Emmens |
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Title: |
Chairman, President and CEO |
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U.S. BANK NATIONAL ASSOCIATION, |
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as Collateral Agent |
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By: |
/s/ Karen Beard |
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Name: |
Karen Beard |
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Title: |
Authorized Signatory |
17
Exhibit 10.5
EXECUTION COPY
Confidential Treatment Requested.
Confidential portions of this document have been redacted and have been
separately filed
with the Commission.
PURCHASE AGREEMENT REGARDING MILESTONE #9
Dated as of September 30, 2009
by and between
VERTEX PHARMACEUTICALS INCORPORATED
and
OLMSTED PARK S.A.
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
TABLE OF CONTENTS
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Page |
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ARTICLE I DEFINITIONS |
1 |
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Section 1.01 |
Definitions |
1 |
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ARTICLE II PURCHASE AND SALE OF THE PURCHASED INTEREST |
7 |
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Section 2.01 |
Purchase and Sale |
7 |
Section 2.02 |
Entitlement to Payments |
8 |
Section 2.03 |
Purchase Price |
8 |
Section 2.04 |
No Assumed Obligations |
9 |
Section 2.05 |
Excluded Assets |
9 |
Section 2.06 |
Closing Deliverables |
9 |
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ARTICLE III REPRESENTATIONS AND WARRANTIES OF VERTEX |
10 |
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Section 3.01 |
Organization |
10 |
Section 3.02 |
Corporate Authorization |
10 |
Section 3.03 |
Governmental and Third Party Authorization |
10 |
Section 3.04 |
Ownership |
11 |
Section 3.05 |
Solvency |
11 |
Section 3.06 |
No Litigation |
11 |
Section 3.07 |
Compliance with Laws |
12 |
Section 3.08 |
No Conflicts |
12 |
Section 3.09 |
Brokers Fees |
13 |
Section 3.10 |
Subordination |
13 |
Section 3.11 |
Janssen Agreement |
13 |
Section 3.12 |
No Set-offs |
15 |
Section 3.13 |
UCC Representations and Warranties |
15 |
Section 3.14 |
Taxes |
15 |
Section 3.15 |
Intellectual Property |
15 |
Section 3.16 |
Certain Information |
16 |
Section 3.17 |
Consolidation |
17 |
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ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE PURCHASER |
17 |
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Section 4.01 |
Organization |
17 |
Section 4.02 |
Authorization |
17 |
Section 4.03 |
Governmental and Third Party Authorization |
17 |
Section 4.04 |
No Litigation |
17 |
Section 4.05 |
No Conflicts |
18 |
Section 4.06 |
Brokers Fees |
18 |
Section 4.07 |
Access to Information |
18 |
i
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
ARTICLE V COVENANTS |
19 |
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Section 5.01 |
Confidentiality; Public Announcement |
19 |
Section 5.02 |
Further Assurances |
20 |
Section 5.03 |
Payments to Vertex on Account of the Purchased Interest |
20 |
Section 5.04 |
Janssen Agreement |
20 |
Section 5.05 |
Termination of the Janssen Agreement |
21 |
Section 5.06 |
Notice of Certain Events |
21 |
Section 5.07 |
Access to Certain Information |
21 |
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ARTICLE VI TERMINATION |
22 |
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Section 6.01 |
Termination Date |
22 |
Section 6.02 |
Effect of Termination |
22 |
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ARTICLE VII MISCELLANEOUS |
23 |
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Section 7.01 |
Survival |
23 |
Section 7.02 |
Specific Performance |
23 |
Section 7.03 |
Notices |
23 |
Section 7.04 |
Successors and Assigns |
25 |
Section 7.05 |
Indemnification |
25 |
Section 7.06 |
Independent Nature of Relationship |
27 |
Section 7.07 |
Tax |
28 |
Section 7.08 |
Entire Agreement |
30 |
Section 7.09 |
Governing Law |
30 |
Section 7.10 |
Waiver of Jury Trial |
31 |
Section 7.11 |
Severability |
31 |
Section 7.12 |
Counterparts; Effectiveness |
31 |
Section 7.13 |
Amendments; No Waivers |
32 |
Section 7.14 |
Interpretation |
32 |
Section 7.15 |
Expenses |
32 |
SCHEDULES
Schedule 3.13 Vertexs Address and Identification Numbers
Schedule 5.03(c) Purchaser Account Information
EXHIBITS
Exhibit A Form of Bill of Sale
Exhibit B Form of Financing Statement
Exhibit C Form of Payment Direction
Exhibit D Form of Legal Opinion of Vertexs Counsel
ii
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
PURCHASE AGREEMENT REGARDING MILESTONE #9
This PURCHASE AGREEMENT REGARDING MILESTONE #9 (this Agreement) is made and entered into as of September 30, 2009 (the Effective Date) by and between Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (Vertex), and Olmsted Park S.A., a société anonyme governed by the laws of the Grand Duchy of Luxembourg (the Purchaser).
WHEREAS, Vertex has the right to receive a payment based on the achievement of a certain milestone under the Janssen Agreement described herein; and
WHEREAS, Vertex wishes to sell, assign, convey and transfer to the Purchaser, and the Purchaser wishes to purchase, acquire and accept from Vertex, the Purchased Interest described herein, upon and subject to the terms and conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual covenants, agreements representations and warranties set forth herein, the parties hereto agree as follows:
Section 1.01 Definitions.
The following terms, as used herein, shall have the following meanings:
Adverse Effect shall mean (i) an adverse effect on: (a) the legality, validity or enforceability of any of the Transaction Documents, the Janssen Agreement or the back-up security interest granted pursuant to Section 2.01(d); (b) the amount of the Milestone Payment; or (c) the timing of the payment of the Milestone Payment after achievement of the Milestone Event; or (ii) a material adverse effect on: (a) the right or ability of Vertex (or any permitted successor or assignee) to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder; (b) the rights or remedies of the Purchaser under any of the Transaction Documents; or (c) the right or ability of Janssen (or any permitted successor or assignee) to perform any of its obligations under the Janssen Agreement that are related, directly or indirectly, to the achievement of the Milestone Event.
Affiliate shall mean any Person that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another Person. For purposes of this definition, control (or its derivatives) shall mean the possession, direct or indirect, of the power or ability to direct or cause the direction of the management and policies of a Person, whether through ownership of equity, voting securities or beneficial interest, by contract or otherwise.
Agreement shall have the meaning set forth in the preamble.
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Ancillary Janssen Documents means the Global Development Plan, the Supply Agreement and the Pharmacovigilance Agreement as such terms are defined in Sections 1.41, 1.106, and 5.7, respectively, of the Janssen Agreement.
Bankruptcy Event shall mean the occurrence of any of the following:
(i) Vertex or any of its Subsidiaries shall commence any case, proceeding or other action (a) under any existing or future law of any jurisdiction, domestic or foreign, relating to bankruptcy, insolvency, reorganization, relief of debtors or the like, seeking to have an order for relief entered with respect to it, or seeking to adjudicate it bankrupt or insolvent, or seeking reorganization, arrangement, adjustment, winding-up, liquidation, dissolution, composition or other relief with respect to all or substantially all of its debts, or (b) seeking appointment of a receiver, trustee, custodian or other similar official for it or for all or substantially all of its assets, or Vertex or any of its Subsidiaries shall make a general assignment for the benefit of its creditors;
(ii) there shall be commenced against Vertex or any of its Subsidiaries any case, proceeding or other action of a nature referred to in clause (i) above that remains undismissed or undischarged for a period of 90 calendar days;
(iii) there shall be commenced against Vertex or any of its Subsidiaries any case, proceeding or other action seeking issuance of a warrant of attachment, execution, distraint or similar process against (a) all or any substantial portion of its assets and/or (b) the Milestone Payment, which results in the entry of an order for any such relief that shall not have been vacated, discharged, stayed, satisfied or bonded pending appeal within 45 calendar days from the entry thereof; or
(iv) Vertex or any of its Subsidiaries shall take any action in furtherance of, or indicating its consent to, approval of, or acquiescence in, any of the acts set forth in clause (i), clause (ii) or clause (iii) above.
Bill of Sale shall mean the bill of sale substantially in the form of Exhibit A.
Business Day shall mean any day other than a Saturday, a Sunday, any day that is a legal holiday under the laws of the State of New York, The Commonwealth of Massachusetts or Luxembourg, or any day on which banking institutions located in the State of New York, The Commonwealth of Massachusetts or Luxembourg are authorized or required by law or other governmental action to close.
Code shall have the meaning set forth in Section 7.07(b).
Confidential Information shall mean, as it relates to any party (or its Affiliates) who provides information (the Disclosing Party) to the other party hereto, all information (whether written or oral, or in electronic or other form) furnished before or after the Effective Date concerning, or relating in any way, directly or indirectly, to the Disclosing Party or its Affiliates (including, in the case of the Purchaser, any of its equityholders) including the terms, conditions and provisions of this Agreement and any other Transaction Document, and in the case of information provided by Vertex or its Affiliates, relating to the Purchased Interest or the
2
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Milestone Payment, including (i) any license, sublicense, assignment, product development, royalty, sale, supply or other agreements (including the Janssen Agreement) involving or relating in any way, directly or indirectly, to the Purchased Interest, the Milestone Payment or the circumstances giving rise to the Purchased Interest, and including all terms and conditions thereof and the identities of the parties thereto, (ii) any reports, data, materials or other documents of any kind relating in any way, directly or indirectly, to the Disclosing Party or its Affiliates, the Purchased Interest, the Milestone Payment or the circumstances giving rise to the Purchased Interest, and including reports, data, materials or other documents of any kind delivered pursuant to or under any of the agreements referred to in clause (i) above, and (iii) any inventions, devices, improvements, formulations, discoveries, compositions, ingredients, patents, patent applications, know-how, processes, trial results, research, developments or any other intellectual property, trade secrets or information involving or relating in any way, directly or indirectly, to the Purchased Interest or the circumstances giving rise to the Purchased Interest. Notwithstanding the foregoing definition, Confidential Information shall not include information that is (v) independently developed or discovered by the Receiving Party without use of or access to any Confidential Information, as demonstrated by documentary evidence, (w) already in the public domain at the time the information is disclosed or has become part of the public domain after such disclosure through no breach of this Agreement, (x) lawfully obtainable from other sources, (y) required to be disclosed in any document to be filed with any Governmental Authority or (z) required to be disclosed by court or administrative order or under securities laws, rules and regulations applicable to any party hereto or pursuant to the rules and regulations of any stock exchange or stock market on which securities of Vertex or its Affiliates or the Purchaser or its Affiliates may be listed for trading.
Discrepancy shall have the meaning set forth in Section 2.02(b).
Effective Date shall have the meaning set forth in the preamble.
Excluded Liabilities and Obligations shall have the meaning set forth in Section 2.04.
Final Determination shall have the meaning set forth in Section 7.07(e).
Financing Statement shall have the meaning set forth in Section 2.01(c).
GAAP means generally accepted accounting principles in the United States of America as in effect from time to time, including those set forth in (1) the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and (2) the statements and pronouncements of the Financial Accounting Standards Board.
Governmental Authority shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign).
Janssen shall mean Janssen Pharmaceutica, N.V., a Belgium corporation, including its successors and assigns.
Janssen Agreement shall mean the License, Development, Manufacturing and Commercialization Agreement by and between Vertex and Janssen effective as of June 30, 2006,
3
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
as such agreement is amended and in effect on the date hereof, together with the Janssen Consent and the Ancillary Janssen Documents, except as expressly set forth herein, as each may be amended and/or restated from time to time after the date hereof in accordance with the terms of this Agreement and any new, substitute or amended agreement by and between Vertex and Janssen relating to the Milestone Payment made after the date hereof in accordance with the terms of this Agreement.
Janssen Consent shall have the meaning in Section 3.03.
Knowledge shall mean, with respect to Vertex, the knowledge of any of the following officers or employees of Vertex: the Chief Executive Officer; the Chief Medical Officer; the General Counsel; the Chief Scientific Officer; the Chief Financial Officer; the Chief Commercial Officer; the Vice President and Corporate Controller; the Head, Business Development & Licensing; and the Deputy General Counsel. An individual will be deemed to have knowledge of a particular fact or other matter if (i) such individual has or at any time had actual knowledge of such fact or other matter or (ii) a prudent individual would be expected to discover or otherwise become aware of such fact or other matter in the course of his or her responsibilities in his or her capacity as an officer or employee of Vertex or in the course of conducting a reasonably diligent review concerning the existence thereof with any employee of Vertex or any of its Subsidiaries who, at the Effective Date, reports directly to such individual and who (x) has responsibilities or (y) would reasonably be expected to have actual knowledge of circumstances or other information, in each case, that would reasonably be expected to be pertinent to such fact or other matter. Notwithstanding anything in this definition to the contrary, Vertex will be deemed to have knowledge of any fact or matter that is the subject of, or referred to within, any written notice it or any of its Subsidiaries has received (whether in hard copy, digital or electronic format).
Lien shall mean any lien, hypothecation, charge, instrument, license, preference, priority, security agreement, security interest, mortgage, option, right of first refusal, privilege, pledge, liability, covenant or order, or any encumbrance, restriction, right or claim of any other Person or Governmental Authority of any kind whatsoever, whether choate or inchoate, filed or unfiled, noticed or unnoticed, recorded or unrecorded, contingent or non-contingent, material or non-material, known or unknown, other than any of the above created solely in favor of the Purchaser by the Transaction Documents.
Losses shall mean, collectively, any and all claims, damages, losses, judgments, liabilities, costs and expenses (including reasonable expenses of investigation and reasonable attorneys fees and expenses), excluding punitive damages, except to the extent punitive damages are paid to a third party.
Milestone Event shall mean the milestone event numbered 9 set forth in the table in Section 9.2.1 of the Janssen Agreement.
Milestone Payment shall mean collectively (i) an amount equal to [***] due and payable to Vertex under Section 9.2.1 of the Janssen Agreement upon the occurrence of Milestone Event [***] due and payable to Vertex under Section 9.2.1 of the Janssen Agreement upon the occurrence of Milestone Event; (ii) the Purchasers Pro-Rata Portion of all additional amounts added to the Milestone Payment under any provision of the Janssen Agreement,
4
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
including any interest assessed in connection with a delay in the payment by Janssen of the Milestone Payment represented by the Purchased Interest pursuant to Section 9.10 of the Janssen Agreement; (iii) all accounts (as defined under the UCC) evidencing the rights to the payment and amount described in clauses (i) and (ii) above; and (iv) all proceeds (as defined under the UCC) of the foregoing.
Payment Direction shall have the meaning set forth in Section 2.06(b).
Person shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization of any kind, but not including a Governmental Authority.
Pro-Rata Portion shall mean, with respect to Vertex, [***] and, with respect to the Purchaser, [***].
Prohibited Amendment shall mean any amendment, modification, restatement or supplement of any provision of the Janssen Agreement that changes in any way (i) the event underlying the Milestone Event, (ii) the amount of the Milestone Payment or (iii) the timing of the payment of the Milestone Payment by Janssen after achievement of the Milestone Event by Janssen. For avoidance of doubt any termination of the Janssen Agreement shall not be deemed a Prohibited Amendment.
Purchased Interest shall mean collectively (i) an undivided 100% interest in the right to receive the Milestone Payment, (ii) the right to enforce directly against Janssen the right to payment of all or any portion of the Milestone Payment represented by the Purchased Interest when earned upon achievement of the Milestone Event pursuant to the Janssen Agreement, and (iii) the right to transfer or assign entitlement to all or a portion of the Milestone Payment represented by the Purchased Interest to third parties in accordance with the terms of this Agreement.
Purchase Price shall have the meaning set forth in Section 2.03.
Purchaser shall have the meaning set forth in the preamble and shall include its successors and assigns.
Purchaser Account shall have the meaning set forth in Section 5.03(c).
Purchaser Indemnified Party shall have the meaning set forth in Section 7.05(a).
Recharacterization shall have the meaning set forth in Section 2.01(d).
Recipient shall have the meaning set forth in Section 5.01(a).
Report shall have the meaning set forth in Section 3.16.
Retained Milestone Payment shall mean U.S. [***] of the total amount payable to Vertex or any of its Affiliates under Section 9.2.1 of the Janssen Agreement upon the occurrence of Milestone Event.
5
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 9.2.2 Notice shall have the meaning set forth in Section 5.04(b).
Set-off shall mean any set-off, rescission, counterclaim, defense, reduction or deduction of any kind. Without limiting the generality of the foregoing, the term Set-off shall include the right by Janssen to reduce the amount of the Milestone Payment for any reason, including without limitation in connection with (i) a breach by Vertex of the Janssen Agreement, (ii) any anti stacking or similar rights with respect to payments to third parties for access to intellectual property rights or data, (iii) any discounted payment obligations in connection with third party sales of generic competitive products, (iv) any rights to credit against any payment obligations any costs, expenses or liabilities of Janssen under the Janssen Agreement, including with respect to (a) Global Development Costs (as defined in the Janssen Agreement), (b) any costs and expenses of patent prosecution, maintenance or enforcement, or (c) defense of third party infringement claims, or (v) any amounts paid or payable pursuant to any indemnification rights or obligations of Vertex or Janssen under the Janssen Agreement.
Subsidiary or Subsidiaries shall mean with respect to any Person (i) any corporation of which the outstanding capital stock having at least a majority of votes entitled to be cast in the election of directors (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time be owned, directly or indirectly, by such Person or by another subsidiary of such Person or (ii) any other Person of which at least a majority voting interest (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time owned, directly or indirectly, by such Person or by another subsidiary of such Person.
Third Party Claim shall have the meaning set forth in Section 7.05(c).
Transaction Documents shall mean, collectively, this Agreement, the Bill of Sale and the Payment Direction.
UCC shall mean the Uniform Commercial Code as in effect from time to time in the State of New York; provided, however, that, if, with respect to any financing statement or by reason of any provisions of law, the perfection or the effect of perfection or non-perfection of the Purchasers ownership interest in the Purchased Interest or of the back-up security interest granted pursuant to Section 2.01(d) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then UCC shall mean the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
Vertex shall have the meaning set forth in the preamble, and its permitted successors and assigns.
Vertex Indemnified Party shall have the meaning set forth in Section 7.05(b).
6
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.01 Purchase and Sale.
7
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.02 Entitlement to Payments.
Section 2.03 Purchase Price.
In full consideration for the sale, assignment, transfer and conveyance of the Purchased Interest, and subject to the terms and conditions set forth herein, the Purchaser shall pay to Vertex on the Effective Date, the sum of U.S. $15,528,988 by wire transfer of immediately available funds to an account designated in writing by Vertex (the Purchase Price).
8
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.04 No Assumed Obligations.
The Purchaser is purchasing, acquiring and accepting only the Purchased Interest and the contractual rights and obligations set forth in this Agreement and is not assuming any liability or obligation of Vertex or any of its Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter, whether under the Janssen Agreement or any Transaction Document or otherwise. All such liabilities and obligations shall be retained by and remain obligations and liabilities of Vertex or its Affiliates (the Excluded Liabilities and Obligations).
Section 2.05 Excluded Assets.
Notwithstanding any provision in this Agreement or any other writing to the contrary, the Purchaser does not, by purchase, acquisition or acceptance of the rights granted hereunder or otherwise pursuant to any of the Transaction Documents, purchase, acquire or accept any assets or contract rights of Vertex under the Janssen Agreement, including the Retained Milestone Payment, other than the Purchased Interest, or any other assets or rights of Vertex. For avoidance of doubt, Vertex retains (i) an undivided 100% interest in the right to receive the Retained Milestone Payment, (ii) Vertexs Pro-Rata Portion of all additional amounts added to the Milestone Payment under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the Milestone Payment pursuant to Section 9.10 of the Janssen Agreement, (iii) the right to enforce directly against Janssen the right to payment of all or any portion of the Retained Milestone Payment when earned upon achievement of Milestone Event pursuant to the Janssen Agreement, (iv) the right to transfer or assign entitlement to all or a portion of the Retained Milestone Payment to third parties, and (v) the other contractual rights related thereto contained in the Janssen Agreement.
Section 2.06 Closing Deliverables.
Simultaneous with the closing of the transactions contemplated hereby on the Effective Date:
9
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Vertex hereby represents and warrants to the Purchaser, as of the Effective Date, the following:
Section 3.01 Organization.
Vertex is a corporation duly incorporated, validly existing and in good standing under the laws of The Commonwealth of Massachusetts. Vertex has all corporate powers and all licenses, authorizations, consents and approvals of all Governmental Authorities required to carry on its business as now conducted. Vertex is duly qualified to do business as a foreign corporation and is in good standing in every jurisdiction in which the failure to do so would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
Section 3.02 Corporate Authorization.
Vertex has all necessary corporate power and authority to enter into, execute and deliver the Transaction Documents and to perform all of the obligations to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder. The Transaction Documents have been, or will be, when executed, duly authorized, executed and delivered by Vertex, and each Transaction Document constitutes, or will constitute, when executed, the legal, valid and binding obligation of Vertex, enforceable against Vertex in accordance with its respective terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors rights generally or general equitable principles.
Section 3.03 Governmental and Third Party Authorization.
The execution and delivery by Vertex of the Transaction Documents, and the performance by Vertex of its obligations and the consummation by Vertex of any of the transactions contemplated hereunder and thereunder, do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any Person, except for (i) the filing of proper financing statements
10
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
under the UCC (ii) the filing of a Current Report on Form 8-K with the Securities and Exchange Commission and (iii) the Janssen Consent. Vertex has obtained prior to its execution and delivery of this Agreement the consent of Janssen required under Section 15.2 of the Janssen Agreement with respect to the assignment and transfer of all of Vertexs right, title and interest in and to the Purchased Interest to the Purchaser and the consummation of the other transactions contemplated by the Transaction Documents (the Janssen Consent), which consent is in full force and effect.
Section 3.04 Ownership.
Vertex is the exclusive owner of the entire right, title (legal and equitable) and interest in and to the Purchased Interest, free and clear of all Liens. Upon the sale, assignment, transfer and conveyance by Vertex of all of its right, title and interest in and to the Purchased Interest to the Purchaser, the Purchaser will acquire good and marketable title to the Purchased Interest free and clear of all Liens. Upon the filing of an appropriate financing statement with the office of the Secretary of the Commonwealth of The Commonwealth of Massachusetts, there will have been duly filed all financing statements or other similar instruments or documents necessary under the applicable UCC (or any comparable law) of all applicable jurisdictions to perfect and maintain the perfection of the Purchasers ownership interest in the Purchased Interest and of the back-up security interest in the Purchased Interest granted by Vertex to the Purchaser pursuant to Section 2.01(d).
Section 3.05 Solvency.
Upon the sale of the Purchased Interest as contemplated by the Transaction Documents, (i) the fair saleable value of Vertexs assets will be greater than the sum of its debts and other obligations, including contingent liabilities, (ii) the present fair saleable value of Vertexs assets will be greater than the amount that would be required to pay its probable liabilities on its existing debts and other obligations, including contingent liabilities, as they become absolute and matured, (iii) Vertex will be able to realize upon its assets and pay its debts and other obligations, including contingent obligations, as they mature, (iv) Vertex will not have unreasonably small capital with which to engage in its business, and (v) Vertex will not incur, nor does it have present plans or intentions to incur, debts or other obligations or liabilities beyond its ability to pay such debts or other obligations or liabilities as they become absolute and matured.
Section 3.06 No Litigation.
There is no (i) action, suit, arbitration proceeding, claim, investigation or other proceeding (whether civil, criminal, administrative or investigative) pending or, to the Knowledge of Vertex, threatened by or against Vertex or any of its Subsidiaries or, to the Knowledge of Vertex, pending or threatened by or against Janssen, at law or in equity, or (ii) inquiry or investigation (whether civil, criminal, administrative or investigative) by or before a Governmental Authority pending or, to the Knowledge of Vertex, threatened against Vertex or any of its Subsidiaries or, to the Knowledge of Vertex, pending or threatened against Janssen, which, in each case with respect to clause (i) or clause (ii) above, (A) if adversely determined, would reasonably be expected to have, individually or in the aggregate, an Adverse Effect, or (B) challenges, or may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the transactions contemplated by any of the Transaction Documents. To
11
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
the Knowledge of Vertex, no event has occurred or circumstance exists that may give rise to or serve as a basis for the commencement of any such action, suit, arbitration, claim, investigation, proceeding or inquiry.
Section 3.07 Compliance with Laws.
None of Vertex or any of its Subsidiaries is (i) in violation of, or has violated or has been given notice of any violation, or, to the Knowledge of Vertex, is under investigation with respect to, or has been threatened to be charged with any violation of, any law, rule, ordinance or regulation of, or any judgment, order, writ, decree, permit or license granted, issued or entered by, any Governmental Authority or (ii) subject to any judgment, order, writ, decree, permit or license granted, issued or entered by any Governmental Authority, in the case of both clause (i) and clause (ii) above, that would reasonably be expected to have, individually or in the aggregate, an Adverse Effect. To the Knowledge of Vertex, no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would constitute or result in a violation by Vertex or any of its Subsidiaries of, or a failure on the part of Vertex or any of its Subsidiaries to comply with, any such law, rule, ordinance or regulation of, or any judgment, order, writ, decree, permit or license granted, issued or entered by, any Governmental Authority, in each case, that would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
Section 3.08 No Conflicts.
Neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby and thereby will: (i) contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or accelerate the performance provided by, in any respect, (A) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit, authorization or license of any Governmental Authority, to which Vertex or any of its Subsidiaries or any of their respective assets or properties may be subject or bound, (B) any contract, agreement, commitment or instrument to which Vertex or any of its Subsidiaries is a party or by which Vertex or any of its Subsidiaries or any of their respective assets or properties is bound or committed or (C) any provisions of the articles of organization or by-laws (or other organizational or constitutional documents) of Vertex or any of its Subsidiaries; (ii) give rise to any right of termination, cancellation or acceleration of any right or obligation of Vertex or any of its Subsidiaries; (iii) except as provided in the Transaction Documents, result in the creation or imposition of any Lien on the Purchased Interest; or (iv) contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, give to any other Person the right to terminate (provided, however, that neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby and thereby will prevent Janssens ability to terminate the Janssen Agreement under Section 13.2 thereof), or accelerate the performance provided by, in any respect, any provision of the Janssen Agreement; provided, however, that, in the case of clause (i)(B) or clause (ii), such contravention, conflict, breach, violation, default or acceleration would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
12
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.09 Brokers Fees.
Vertex has not taken any action that would entitle any Person other than Morgan Stanley & Co. Incorporated (whose fees shall be paid by Vertex) to any commission or brokers fee in connection with the transactions contemplated by the Transaction Documents.
Section 3.10 Subordination.
The claims and rights of the Purchaser created by any Transaction Document in and to the Purchased Interest are not and shall not, at any time, be subordinated by Vertex to any creditor of Vertex or any other Person or Governmental Authority.
Section 3.11 Janssen Agreement.
13
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
14
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.12 No Set-offs.
Other than as set forth in Section 9.9 and Section 13.4.1 of the Janssen Agreement, Janssen has no right of Set-off under any contract (including the Janssen Agreement) or other agreement against the Milestone Payment payable to Vertex under the Janssen Agreement. Janssen has not exercised, and, to Vertexs Knowledge, Janssen has not had the right to exercise, and, to Vertexs Knowledge, no event or condition exists that, upon notice or passage of time or both, would reasonably be expected to permit Janssen to exercise, any Set-off against the Milestone Payment payable to Vertex under the Janssen Agreement.
Section 3.13 UCC Representations and Warranties.
Section 3.14 Taxes.
No deduction or withholding for or on account of any tax has been made, or was required under applicable law to be made, from any payment to Vertex under the Janssen Agreement.
Section 3.15 Intellectual Property.
15
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.16 Certain Information.
16
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.17 Consolidation.
As of the Effective Date, Vertex does not believe that the Securities and Exchange Commission or GAAP requires Vertex to report its financial results on a consolidated basis with the financial results of the Purchaser as a result of Vertex entering into this Agreement or consummating the transactions contemplated by this Agreement.
The Purchaser hereby represents and warrants to Vertex, as of the Effective Date, the following:
Section 4.01 Organization.
The Purchaser is a société anonyme, duly formed, validly existing and in good standing under the laws of the Grand Duchy of Luxembourg. The Purchaser has all necessary powers and all licenses, authorizations, consents and approvals of all Governmental Authorities required to carry on its business as now conducted and to execute and deliver, and perform its obligations under, the Transaction Documents.
Section 4.02 Authorization.
The Purchaser has all necessary power and authority to enter into, execute and deliver the Transaction Documents and to perform all of the obligations of the Purchaser to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder. The Transaction Documents have been, or will be, when executed, duly authorized, executed and delivered by the Purchaser, and each Transaction Document constitutes, or will constitute, when executed, the legal, valid and binding obligation of the Purchaser, enforceable against the Purchaser in accordance with its respective terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors rights generally or general equitable principles.
Section 4.03 Governmental and Third Party Authorization.
The execution and delivery by the Purchaser of the Transaction Documents, and the performance by the Purchaser of its obligations and the consummation of any of the transactions contemplated hereunder and thereunder, do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any other Person.
Section 4.04 No Litigation.
There is no (i) action, suit, arbitration proceeding, claim, investigation or other proceeding (whether civil, criminal, administrative or investigative) pending, or, to the knowledge of the Purchaser, threatened by or against the Purchaser, at law or in equity, or (ii) inquiry or investigation (whether civil, criminal, administrative or investigative) by or before a Governmental Authority pending or, to the knowledge of the Purchaser, threatened against the
17
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Purchaser, which, in each case with respect to clause (i) or clause (ii) above, (A) if adversely determined would reasonably be expected to have, individually or in the aggregate, a material adverse effect on (x) the right or ability of the Purchaser to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder or (y) the rights or remedies of Vertex and its Affiliates under any of the Transaction Documents, or an adverse effect on the legality, validity or enforceability of any of the Transaction Documents, (B) challenges, or may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the transactions contemplated by any of the Transaction Documents.
Section 4.05 No Conflicts.
Neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby or thereby will contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or accelerate the performance provided by, in any respect, (i) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit or license of any Governmental Authority, to which the Purchaser or any of its assets or properties may be subject or bound, (ii) any contract, agreement, commitment or instrument to which the Purchaser is a party or by which the Purchaser or any of its assets or properties is bound or committed or (iii) any provisions of the organizational or constitutional documents of the Purchaser, except in the case of clause (ii) above, as would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the right or ability of the Purchaser to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder.
Section 4.06 Brokers Fees.
The Purchaser has not taken any action that would entitle any Person to any commission or brokers fee in connection with the transactions contemplated by the Transaction Documents.
Section 4.07 Access to Information.
The Purchaser acknowledges that it has (i) reviewed a redacted copy of the Janssen Agreement (with, for the avoidance of doubt, the Ancillary Janssen Documents redacted) and the Report (in reliance on the representations and warranties of Vertex set forth herein, including Section 3.11(b)) and (ii) had the opportunity to ask questions of, and to receive answers from, representatives of Vertex concerning the Janssen Agreement and the Milestone Payment. The Purchaser has such knowledge, sophistication and experience in financial and business matters that it is capable of evaluating the risks and merits of purchasing, acquiring and accepting the Purchased Interest in accordance with the terms of this Agreement. The Purchaser acknowledges and agrees that (i) the Report was furnished to the Purchaser by Vertex for the Purchasers convenience, (ii) the Report was not prepared by Vertex, (iii) Vertex did not, and does not, adopt or endorse the contents of the Report, (iv) the Report constitutes the work product solely of L.E.K. Consulting LLC and (v) Vertex disclaims any representation, either express or implied, that the information in the Report is accurate or that the statements in the Report coincide with Vertexs views.
18
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
The parties hereto covenant and agree as follows:
Section 5.01 Confidentiality; Public Announcement.
19
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.02 Further Assurances.
The Purchaser and Vertex agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be necessary or desirable, or reasonably requested by the other party hereto, in each case at the expense of the Purchaser, in order to vest and maintain in the Purchaser good and marketable title in and to the Purchased Interest free and clear of all Liens, including the perfection and maintenance of perfection of the Purchasers ownership interest in the Purchased Interest and of the back-up security interest in the Purchased Interest granted by Vertex to the Purchaser pursuant to Section 2.01(d).
Section 5.03 Payments to Vertex on Account of the Purchased Interest.
Section 5.04 Janssen Agreement.
20
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.05 Termination of the Janssen Agreement.
Section 5.06 Notice of Certain Events.
Section 5.07 Access to Certain Information.
21
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
(b) Vertex agrees that the Purchaser shall have no liability (whether direct or indirect, in contract or tort or otherwise) to any Vertex Indemnified Party for or in connection with any of the financial records or financial information provided by the Purchaser pursuant to Section 5.07(a) hereof except for Losses incurred by Vertex that are finally judicially determined to have resulted from actual fraud, gross negligence or willful misconduct on the part of the Purchaser.
Section 6.01 Termination Date.
This Agreement shall terminate on the date upon which the earlier of the following occurs: (i) the payment to the Purchaser of the Milestone Payment in full pursuant to the terms of the Transaction Documents; (ii) the expiration of the Janssen Agreement; or (iii) the termination of the Janssen Agreement where licenses granted to Janssen under Article 7 of the Janssen Agreement terminate.
Section 6.02 Effect of Termination.
In the event of the termination of this Agreement pursuant to Section 6.01, this Agreement shall become void and of no further force and effect, except for: (i) those rights and obligations that have accrued prior to the date of such termination, including the payment in accordance with the terms hereof of the Milestone Payment earned prior the date of such termination; (ii) in the event of termination of this Agreement pursuant to Section 6.01(iii), the right to payment of the Milestone Payment under Section 5.05, and Section 5.03, and Section 5.04(b); and (iii) Article I, Article VI and Article VII and Section 2.02(b) (but only the last sentence thereof), Section 5.01, and Section 5.07 (but only for the period ending 45 days after the end of the calendar quarter in which such termination occurred), shall survive the termination of this Agreement and there shall be no liability on the part of any party hereto, any of its Affiliates or controlling Persons or any of their respective officers, directors, shareholders, members, partners, controlling Persons, managers, agents or employees, other than as provided for in this Section 6.02. Nothing contained in this Section 6.02 shall relieve any party hereto from liability for any breach of this Agreement that occurs prior to such termination.
22
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.01 Survival.
All representations and warranties made herein and in any other Transaction Document or any certificates delivered pursuant to this Agreement shall survive the execution and delivery of this Agreement and shall continue to survive until October 31, 2012; provided, however, that the representations and warranties contained in Sections 3.08 and 3.11 shall survive until the date that is one year after termination of this Agreement; provided, further, however, that the representations and warranties contained in Sections 3.01, 3.02, 3.03, 3.04, 3.09, 3.10, 3.12 and 3.14 shall survive indefinitely; provided, further, however, that it is understood and agreed that, notwithstanding the survival provisions of this Section 7.01, all of the representations and warranties made by the parties hereto are made only as of the Effective Date. The obligations of (a) Vertex to indemnify and hold harmless any Purchaser Indemnified Party under Section 7.05 and (b) the Purchaser to indemnify and hold harmless any Vertex Indemnified Party under Section 7.05, in each case shall terminate (i) when the applicable representation or warranty terminates pursuant to this Section 7.01, with respect to claims made pursuant to Section 7.05(a)(i) and Section 7.05(b)(i), as applicable, and (ii) 60 days after the expiration of the applicable statute of limitations (or waivers or extensions thereof), with respect to claims made pursuant to Section 7.05(a)(ii), Section 7.05(b)(ii), Section 7.05(b)(iii) or 7.05(b)(iv); provided, however, that, in each case, such obligations to indemnify and hold harmless shall not terminate with respect to any item as to which a Purchaser Indemnified Party or a Vertex Indemnified Party shall have, before the expiration of the applicable period, previously notified the indemnifying party pursuant to Section 7.05.
Section 7.02 Specific Performance.
Each of the parties hereto acknowledges that the other party hereto may have no adequate remedy at law if it fails to perform any of its obligations under any of the Transaction Documents. In such event, each of the parties hereto agrees that the other party hereto shall have the right, in addition to any other rights it may have (whether at law or in equity), to specific performance of this Agreement. Neither party hereto shall have any right to terminate this Agreement or any other Transaction Document as a result of any breach by the other party hereto hereof or thereof, but instead shall have the rights set forth in this Agreement, including this Article VII.
Section 7.03 Notices.
All notices, consents, waivers and communications hereunder given by any party hereto to the other party hereto shall be in writing, signed by the party hereto giving such notice and be deemed to have been duly given when (i) delivered by hand, (ii) sent by facsimile (with written confirmation of receipt) if sent during regular business hours on a Business Day (and, if not, then on the next succeeding Business Day), provided, however, that a copy is mailed by registered mail, return receipt requested, (iii) received by the addressee, if sent by nationally recognized overnight delivery service (receipt requested), or (iv) sent by email if sent during regular business hours on a Business Day (and, if not, then on the next succeeding Business Day), provided, however, that a copy is mailed by a nationally recognized overnight delivery service
23
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
(provided, however, that delivery will not be deemed effective unless the addressee provides written confirmation of receipt by facsimile or return email (automatic email responses do not constitute confirmation)), in each case, to the applicable addresses, facsimile numbers and/or email addresses set forth below:
If to the Purchaser to:
Olmsted Park S.A.
20, rue de la Poste
L-2346 Luxembourg
Attention: Board of Directors
with a copy (which shall not constitute notice) to:
Akin Gump Strauss Hauer &
Feld LLP
One Bryant Park
New York, NY 10036
Attention: Stuart E. Leblang
Facsimile: (212) 872-1002
Email: sleblang@akingump.com
If to Vertex to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Philippe Tinmouth
Head, Business Development & Licensing
Facsimile: 617-444-6632
Email: phil_tinmouth@vrtx.com
with a copy (which shall not constitute notice) to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Kenneth S. Boger, Esq.
Senior Vice President and General Counsel
Facsimile: 617-444-7117
Email: ken_boger@vrtx.com
or to such other address or addresses, facsimile number or numbers or email address or addresses as the Purchaser or Vertex may from time to time designate by notice as provided herein, except that notices of such changes shall be effective only upon receipt.
24
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.04 Successors and Assigns.
The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. Neither party shall be entitled to assign, directly or indirectly, any of its obligations and rights under any of the Transaction Documents, including by operation of law or otherwise, without the prior written consent of the other party; provided, however, that (i) Vertex may, without the consent of the Purchaser, assign any of its obligations or rights under the Transaction Documents to any other Person with which it may merge or consolidate or to which it may sell all or substantially all of its assets, provided that the assignee under such assignment agrees to be bound by the terms of the Transaction Documents and furnishes a written agreement to the Purchaser in form and substance reasonably satisfactory to the Purchaser to that effect, and (ii) Purchaser may assign this Agreement in its entirety without the consent of Vertex, provided, however, that the Purchaser shall give notice of any such assignment to Vertex after the occurrence thereof. Vertex shall be under no obligation to reaffirm any representations, warranties or covenants made in this Agreement or any of the other Transaction Documents or take any other action in connection with any such assignment by the Purchaser.
Section 7.05 Indemnification.
25
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
26
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.06 Independent Nature of Relationship.
27
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.07 Tax.
28
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
29
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.08 Entire Agreement.
This Agreement, together with the Schedule and Exhibits hereto (which are incorporated herein by reference), and the other Transaction Documents constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior agreements, understandings and negotiations, both written and oral, between the parties hereto with respect to the subject matter of this Agreement. No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Schedule, Exhibits or other Transaction Documents) has been made or relied upon by either party hereto. Neither this Agreement, nor any provision hereof, is intended to confer upon any Person other than the parties hereto any rights or remedies hereunder.
Section 7.09 Governing Law.
30
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.10 Waiver of Jury Trial.
EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HERETO HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT THE OTHER PARTY HERETO WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.10.
Section 7.11 Severability.
If one or more provisions of this Agreement are held to be invalid or unenforceable by a court of competent jurisdiction, such provision shall be excluded from this Agreement and the balance of this Agreement shall be interpreted as if such provision were so excluded and shall remain in full force and effect and be enforceable in accordance with its terms. Any provision of this Agreement held invalid or unenforceable only in part or degree by a court of competent jurisdiction shall remain in full force and effect to the extent not held invalid or unenforceable.
Section 7.12 Counterparts; Effectiveness.
This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each party hereto shall have received a counterpart hereof signed by the other party hereto. Any counterpart may be executed by facsimile signature and such facsimile signature shall be deemed an original.
31
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.13 Amendments; No Waivers.
Section 7.14 Interpretation.
Section 7.15 Expenses.
Each of the parties hereto shall pay all of their own fees and expenses incurred in connection with the negotiation of and entering into, this Agreement and the other Transaction Documents, and the consummation of the transactions contemplated hereby and thereby; provided, however, that Vertex shall reimburse or pay, promptly upon request from the Purchaser, fifty percent (50%) of the reasonable and documented fees and expenses of the Purchaser, including reasonable and documented legal fees and expenses, incurred on behalf of the Purchaser in connection with the structuring, negotiation and entry into this Agreement and the other Transaction Documents and the consummation of the transactions contemplated hereby and thereby up to a maximum of U.S. $250,000.00.
32
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
[Signature page follows]
33
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective authorized officers as of the date first above written.
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VERTEX PHARMACEUTICALS INCORPORATED |
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By: |
/s/ Matthew W. Emmens |
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Name: |
Matthew W. Emmens |
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Title: |
Chairman, President and CEO |
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OLMSTED PARK S.A. |
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By: |
/s/ Julia Vogelweith |
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Name: |
Julia Vogelweith |
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Title: |
Director |
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By: |
/s/ Hille-Paul Schut |
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Name: |
Hille-Paul Schut |
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Title: |
Director |
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By: |
/s/ Xavier de Cillia |
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Name: |
Xavier de Cillia |
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Title: |
Director |
Exhibit 10.6
EXECUTION COPY
Confidential Treatment Requested.
Confidential portions of this document have been redacted and have been
separately filed
with the Commission.
PURCHASE AGREEMENT REGARDING MILESTONE #10
Dated as of September 30, 2009
by and between
VERTEX PHARMACEUTICALS INCORPORATED
and
OLMSTED PARK S.A.
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
TABLE OF CONTENTS
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Page |
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ARTICLE I DEFINITIONS |
1 |
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Section 1.01 |
Definitions |
1 |
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ARTICLE II PURCHASE AND SALE OF THE PURCHASED INTEREST |
6 |
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Section 2.01 |
Purchase and Sale |
6 |
Section 2.02 |
Entitlement to Payments |
8 |
Section 2.03 |
Purchase Price |
8 |
Section 2.04 |
No Assumed Obligations |
8 |
Section 2.05 |
Excluded Assets |
9 |
Section 2.06 |
Closing Deliverables |
9 |
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ARTICLE III REPRESENTATIONS AND WARRANTIES OF VERTEX |
10 |
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Section 3.01 |
Organization |
10 |
Section 3.02 |
Corporate Authorization |
10 |
Section 3.03 |
Governmental and Third Party Authorization |
10 |
Section 3.04 |
Ownership |
10 |
Section 3.05 |
Solvency |
11 |
Section 3.06 |
No Litigation |
11 |
Section 3.07 |
Compliance with Laws |
11 |
Section 3.08 |
No Conflicts |
12 |
Section 3.09 |
Brokers Fees |
12 |
Section 3.10 |
Subordination |
12 |
Section 3.11 |
Janssen Agreement |
13 |
Section 3.12 |
No Set-offs |
14 |
Section 3.13 |
UCC Representations and Warranties |
15 |
Section 3.14 |
Taxes |
15 |
Section 3.15 |
Intellectual Property |
15 |
Section 3.16 |
Certain Information |
16 |
Section 3.17 |
Consolidation |
16 |
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ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE PURCHASER |
17 |
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Section 4.01 |
Organization |
17 |
Section 4.02 |
Authorization |
17 |
Section 4.03 |
Governmental and Third Party Authorization |
17 |
Section 4.04 |
No Litigation |
17 |
Section 4.05 |
No Conflicts |
18 |
Section 4.06 |
Brokers Fees |
18 |
Section 4.07 |
Access to Information |
18 |
i
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
ARTICLE V COVENANTS |
18 |
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Section 5.01 |
Confidentiality; Public Announcement |
19 |
Section 5.02 |
Further Assurances |
20 |
Section 5.03 |
Payments to Vertex on Account of the Purchased Interest |
20 |
Section 5.04 |
Janssen Agreement |
20 |
Section 5.05 |
Termination of the Janssen Agreement |
21 |
Section 5.06 |
Notice of Certain Events |
21 |
Section 5.07 |
Access to Certain Information |
21 |
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ARTICLE VI TERMINATION |
22 |
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Section 6.01 |
Termination Date |
22 |
Section 6.02 |
Effect of Termination |
22 |
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ARTICLE VII MISCELLANEOUS |
23 |
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Section 7.01 |
Survival |
23 |
Section 7.02 |
Specific Performance |
23 |
Section 7.03 |
Notices |
23 |
Section 7.04 |
Successors and Assigns |
25 |
Section 7.05 |
Indemnification |
25 |
Section 7.06 |
Independent Nature of Relationship |
27 |
Section 7.07 |
Tax |
28 |
Section 7.08 |
Entire Agreement |
30 |
Section 7.09 |
Governing Law |
30 |
Section 7.10 |
Waiver of Jury Trial |
31 |
Section 7.11 |
Severability |
31 |
Section 7.12 |
Counterparts; Effectiveness |
31 |
Section 7.13 |
Amendments; No Waivers |
32 |
Section 7.14 |
Interpretation |
32 |
Section 7.15 |
Expenses |
32 |
SCHEDULES |
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Schedule 3.13 Vertexs Address and Identification Numbers |
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Schedule 5.03(c) Purchaser Account Information |
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EXHIBITS |
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Exhibit A |
Form of Bill of Sale |
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Exhibit B |
Form of Financing Statement |
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Exhibit C |
Form of Payment Direction |
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Exhibit D |
Form of Legal Opinion of Vertexs Counsel |
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ii
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
PURCHASE AGREEMENT REGARDING MILESTONE #10
This PURCHASE AGREEMENT REGARDING MILESTONE #10 (this Agreement) is made and entered into as of September 30, 2009 (the Effective Date) by and between Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (Vertex), and Olmsted Park S.A., a société anonyme governed by the laws of the Grand Duchy of Luxembourg (the Purchaser).
WHEREAS, Vertex has the right to receive a payment based on the achievement of a certain milestone under the Janssen Agreement described herein; and
WHEREAS, Vertex wishes to sell, assign, convey and transfer to the Purchaser, and the Purchaser wishes to purchase, acquire and accept from Vertex, the Purchased Interest described herein, upon and subject to the terms and conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual covenants, agreements representations and warranties set forth herein, the parties hereto agree as follows:
Section 1.01 Definitions.
The following terms, as used herein, shall have the following meanings:
Adverse Effect shall mean (i) an adverse effect on: (a) the legality, validity or enforceability of any of the Transaction Documents, the Janssen Agreement or the back-up security interest granted pursuant to Section 2.01(d); (b) the amount of the Milestone Payment; or (c) the timing of the payment of the Milestone Payment after achievement of the Milestone Event; or (ii) a material adverse effect on: (a) the right or ability of Vertex (or any permitted successor or assignee) to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder; (b) the rights or remedies of the Purchaser under any of the Transaction Documents; or (c) the right or ability of Janssen (or any permitted successor or assignee) to perform any of its obligations under the Janssen Agreement that are related, directly or indirectly, to the achievement of the Milestone Event.
Affiliate shall mean any Person that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another Person. For purposes of this definition, control (or its derivatives) shall mean the possession, direct or indirect, of the power or ability to direct or cause the direction of the management and policies of a Person, whether through ownership of equity, voting securities or beneficial interest, by contract or otherwise.
Agreement shall have the meaning set forth in the preamble.
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Ancillary Janssen Documents means the Global Development Plan, the Supply Agreement and the Pharmacovigilance Agreement as such terms are defined in Sections 1.41, 1.106, and 5.7, respectively, of the Janssen Agreement.
Bankruptcy Event shall mean the occurrence of any of the following:
(i) Vertex or any of its Subsidiaries shall commence any case, proceeding or other action (a) under any existing or future law of any jurisdiction, domestic or foreign, relating to bankruptcy, insolvency, reorganization, relief of debtors or the like, seeking to have an order for relief entered with respect to it, or seeking to adjudicate it bankrupt or insolvent, or seeking reorganization, arrangement, adjustment, winding-up, liquidation, dissolution, composition or other relief with respect to all or substantially all of its debts, or (b) seeking appointment of a receiver, trustee, custodian or other similar official for it or for all or substantially all of its assets, or Vertex or any of its Subsidiaries shall make a general assignment for the benefit of its creditors;
(ii) there shall be commenced against Vertex or any of its Subsidiaries any case, proceeding or other action of a nature referred to in clause (i) above that remains undismissed or undischarged for a period of 90 calendar days;
(iii) there shall be commenced against Vertex or any of its Subsidiaries any case, proceeding or other action seeking issuance of a warrant of attachment, execution, distraint or similar process against (a) all or any substantial portion of its assets and/or (b) the Milestone Payment, which results in the entry of an order for any such relief that shall not have been vacated, discharged, stayed, satisfied or bonded pending appeal within 45 calendar days from the entry thereof; or
(iv) Vertex or any of its Subsidiaries shall take any action in furtherance of, or indicating its consent to, approval of, or acquiescence in, any of the acts set forth in clause (i), clause (ii) or clause (iii) above.
Bill of Sale shall mean the bill of sale substantially in the form of Exhibit A.
Business Day shall mean any day other than a Saturday, a Sunday, any day that is a legal holiday under the laws of the State of New York, The Commonwealth of Massachusetts or Luxembourg, or any day on which banking institutions located in the State of New York, The Commonwealth of Massachusetts or Luxembourg are authorized or required by law or other governmental action to close.
Code shall have the meaning set forth in Section 7.07(b).
Confidential Information shall mean, as it relates to any party (or its Affiliates) who provides information (the Disclosing Party) to the other party hereto, all information (whether written or oral, or in electronic or other form) furnished before or after the Effective Date concerning, or relating in any way, directly or indirectly, to the Disclosing Party or its Affiliates (including, in the case of the Purchaser, any of its equityholders) including the terms, conditions and provisions of this Agreement and any other Transaction Document, and in the case of
2
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
information provided by Vertex or its Affiliates, relating to the Purchased Interest or the Milestone Payment, including (i) any license, sublicense, assignment, product development, royalty, sale, supply or other agreements (including the Janssen Agreement) involving or relating in any way, directly or indirectly, to the Purchased Interest, the Milestone Payment or the circumstances giving rise to the Purchased Interest, and including all terms and conditions thereof and the identities of the parties thereto, (ii) any reports, data, materials or other documents of any kind relating in any way, directly or indirectly, to the Disclosing Party or its Affiliates, the Purchased Interest, the Milestone Payment or the circumstances giving rise to the Purchased Interest, and including reports, data, materials or other documents of any kind delivered pursuant to or under any of the agreements referred to in clause (i) above, and (iii) any inventions, devices, improvements, formulations, discoveries, compositions, ingredients, patents, patent applications, know-how, processes, trial results, research, developments or any other intellectual property, trade secrets or information involving or relating in any way, directly or indirectly, to the Purchased Interest or the circumstances giving rise to the Purchased Interest. Notwithstanding the foregoing definition, Confidential Information shall not include information that is (v) independently developed or discovered by the Receiving Party without use of or access to any Confidential Information, as demonstrated by documentary evidence, (w) already in the public domain at the time the information is disclosed or has become part of the public domain after such disclosure through no breach of this Agreement, (x) lawfully obtainable from other sources, (y) required to be disclosed in any document to be filed with any Governmental Authority or (z) required to be disclosed by court or administrative order or under securities laws, rules and regulations applicable to any party hereto or pursuant to the rules and regulations of any stock exchange or stock market on which securities of Vertex or its Affiliates or the Purchaser or its Affiliates may be listed for trading.
Discrepancy shall have the meaning set forth in Section 2.02(b).
Effective Date shall have the meaning set forth in the preamble.
Excluded Liabilities and Obligations shall have the meaning set forth in Section 2.04.
Final Determination shall have the meaning set forth in Section 7.07(e).
Financing Statement shall have the meaning set forth in Section 2.01(c).
GAAP means generally accepted accounting principles in the United States of America as in effect from time to time, including those set forth in (1) the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and (2) the statements and pronouncements of the Financial Accounting Standards Board.
Governmental Authority shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign).
Janssen shall mean Janssen Pharmaceutica, N.V., a Belgium corporation, including its successors and assigns.
3
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Janssen Agreement shall mean the License, Development, Manufacturing and Commercialization Agreement by and between Vertex and Janssen effective as of June 30, 2006, as such agreement is amended and in effect on the date hereof, together with the Janssen Consent and the Ancillary Janssen Documents, except as expressly set forth herein, as each may be amended and/or restated from time to time after the date hereof in accordance with the terms of this Agreement and any new, substitute or amended agreement by and between Vertex and Janssen relating to the Milestone Payment made after the date hereof in accordance with the terms of this Agreement.
Janssen Consent shall have the meaning in Section 3.03.
Knowledge shall mean, with respect to Vertex, the knowledge of any of the following officers or employees of Vertex: the Chief Executive Officer; the Chief Medical Officer; the General Counsel; the Chief Scientific Officer; the Chief Financial Officer; the Chief Commercial Officer; the Vice President and Corporate Controller; the Head, Business Development & Licensing; and the Deputy General Counsel. An individual will be deemed to have knowledge of a particular fact or other matter if (i) such individual has or at any time had actual knowledge of such fact or other matter or (ii) a prudent individual would be expected to discover or otherwise become aware of such fact or other matter in the course of his or her responsibilities in his or her capacity as an officer or employee of Vertex or in the course of conducting a reasonably diligent review concerning the existence thereof with any employee of Vertex or any of its Subsidiaries who, at the Effective Date, reports directly to such individual and who (x) has responsibilities or (y) would reasonably be expected to have actual knowledge of circumstances or other information, in each case, that would reasonably be expected to be pertinent to such fact or other matter. Notwithstanding anything in this definition to the contrary, Vertex will be deemed to have knowledge of any fact or matter that is the subject of, or referred to within, any written notice it or any of its Subsidiaries has received (whether in hard copy, digital or electronic format).
Lien shall mean any lien, hypothecation, charge, instrument, license, preference, priority, security agreement, security interest, mortgage, option, right of first refusal, privilege, pledge, liability, covenant or order, or any encumbrance, restriction, right or claim of any other Person or Governmental Authority of any kind whatsoever, whether choate or inchoate, filed or unfiled, noticed or unnoticed, recorded or unrecorded, contingent or non-contingent, material or non-material, known or unknown, other than any of the above created solely in favor of the Purchaser by the Transaction Documents.
Losses shall mean, collectively, any and all claims, damages, losses, judgments, liabilities, costs and expenses (including reasonable expenses of investigation and reasonable attorneys fees and expenses), excluding punitive damages, except to the extent punitive damages are paid to a third party.
Milestone Event shall mean the milestone event numbered 10 set forth in the table in Section 9.2.1 of the Janssen Agreement.
Milestone Payment shall mean collectively (i) an amount equal to [***] due and payable to Vertex under Section 9.2.1 of the Janssen Agreement upon the occurrence of
4
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Milestone Event due and payable to Vertex under Section 9.2.1 of the Janssen Agreement upon the occurrence of Milestone Event; (ii) all additional amounts added to the Milestone Payment under any provision of the Janssen Agreement, including any interest assessed in connection with a delay in the payment by Janssen of the Milestone Payment represented by the Purchased Interest pursuant to Section 9.10 of the Janssen Agreement; (iii) all accounts (as defined under the UCC) evidencing the rights to the payment and amount described in clauses (i) and (ii) above; and (iv) all proceeds (as defined under the UCC) of the foregoing.
Payment Direction shall have the meaning set forth in Section 2.06(b).
Person shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization of any kind, but not including a Governmental Authority.
Prohibited Amendment shall mean any amendment, modification, restatement or supplement of any provision of the Janssen Agreement that changes in any way (i) the event underlying the Milestone Event, (ii) the amount of the Milestone Payment or (iii) the timing of the payment of the Milestone Payment by Janssen after achievement of the Milestone Event by Janssen. For avoidance of doubt any termination of the Janssen Agreement shall not be deemed a Prohibited Amendment.
Purchased Interest shall mean collectively (i) an undivided 100% interest in the right to receive the Milestone Payment, (ii) the right to enforce directly against Janssen the right to payment of all or any portion of the Milestone Payment represented by the Purchased Interest when earned upon achievement of the Milestone Event pursuant to the Janssen Agreement, and (iii) the right to transfer or assign entitlement to all or a portion of the Milestone Payment represented by the Purchased Interest to third parties in accordance with the terms of this Agreement.
Purchase Price shall have the meaning set forth in Section 2.03.
Purchaser shall have the meaning set forth in the preamble and shall include its successors and assigns.
Purchaser Account shall have the meaning set forth in Section 5.03(c).
Purchaser Indemnified Party shall have the meaning set forth in Section 7.05(a).
Recharacterization shall have the meaning set forth in Section 2.01(d).
Recipient shall have the meaning set forth in Section 5.01(a).
Report shall have the meaning set forth in Section 3.16.
Section 9.2.2 Notice shall have the meaning set forth in Section 5.04(b).
Set-off shall mean any set-off, rescission, counterclaim, defense, reduction or deduction of any kind. Without limiting the generality of the foregoing, the term Set-off shall
5
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
include the right by Janssen to reduce the amount of the Milestone Payment for any reason, including without limitation in connection with (i) a breach by Vertex of the Janssen Agreement, (ii) any anti stacking or similar rights with respect to payments to third parties for access to intellectual property rights or data, (iii) any discounted payment obligations in connection with third party sales of generic competitive products, (iv) any rights to credit against any payment obligations any costs, expenses or liabilities of Janssen under the Janssen Agreement, including with respect to (a) Global Development Costs (as defined in the Janssen Agreement), (b) any costs and expenses of patent prosecution, maintenance or enforcement, or (c) defense of third party infringement claims, or (v) any amounts paid or payable pursuant to any indemnification rights or obligations of Vertex or Janssen under the Janssen Agreement.
Subsidiary or Subsidiaries shall mean with respect to any Person (i) any corporation of which the outstanding capital stock having at least a majority of votes entitled to be cast in the election of directors (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time be owned, directly or indirectly, by such Person or by another subsidiary of such Person or (ii) any other Person of which at least a majority voting interest (or, if there are no such voting interests, 50% or more of the equity interests) under ordinary circumstances is at the time owned, directly or indirectly, by such Person or by another subsidiary of such Person.
Third Party Claim shall have the meaning set forth in Section 7.05(c).
Transaction Documents shall mean, collectively, this Agreement, the Bill of Sale and the Payment Direction.
UCC shall mean the Uniform Commercial Code as in effect from time to time in the State of New York; provided, however, that, if, with respect to any financing statement or by reason of any provisions of law, the perfection or the effect of perfection or non-perfection of the Purchasers ownership interest in the Purchased Interest or of the back-up security interest granted pursuant to Section 2.01(d) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then UCC shall mean the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
Vertex shall have the meaning set forth in the preamble, and its permitted successors and assigns.
Vertex Indemnified Party shall have the meaning set forth in Section 7.05(b).
Section 2.01 Purchase and Sale.
6
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
7
Information redacted pursuant to a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.02 Entitlement to Payments.
Section 2.03 Purchase Price.
In full consideration for the sale, assignment, transfer and conveyance of the Purchased Interest, and subject to the terms and conditions set forth herein, the Purchaser shall pay to Vertex on the Effective Date, the sum of U.S. $17,254,431 by wire transfer of immediately available funds to an account designated in writing by Vertex (the Purchase Price).
Section 2.04 No Assumed Obligations.
The Purchaser is purchasing, acquiring and accepting only the Purchased Interest and the contractual rights and obligations set forth in this Agreement and is not assuming any liability or obligation of Vertex or any of its Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter, whether under the Janssen Agreement or any Transaction Document or otherwise. All such liabilities and obligations shall be retained by and remain obligations and liabilities of Vertex or its Affiliates (the Excluded Liabilities and Obligations).
8
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 2.05 Excluded Assets.
Notwithstanding any provision in this Agreement or any other writing to the contrary, the Purchaser does not, by purchase, acquisition or acceptance of the rights granted hereunder or otherwise pursuant to any of the Transaction Documents, purchase, acquire or accept any assets or contract rights of Vertex under the Janssen Agreement, other than the Purchased Interest, or any other assets or rights of Vertex.
Section 2.06 Closing Deliverables.
Simultaneous with the closing of the transactions contemplated hereby on the Effective Date:
9
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Vertex hereby represents and warrants to the Purchaser, as of the Effective Date, the following:
Section 3.01 Organization.
Vertex is a corporation duly incorporated, validly existing and in good standing under the laws of The Commonwealth of Massachusetts. Vertex has all corporate powers and all licenses, authorizations, consents and approvals of all Governmental Authorities required to carry on its business as now conducted. Vertex is duly qualified to do business as a foreign corporation and is in good standing in every jurisdiction in which the failure to do so would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
Section 3.02 Corporate Authorization.
Vertex has all necessary corporate power and authority to enter into, execute and deliver the Transaction Documents and to perform all of the obligations to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder. The Transaction Documents have been, or will be, when executed, duly authorized, executed and delivered by Vertex, and each Transaction Document constitutes, or will constitute, when executed, the legal, valid and binding obligation of Vertex, enforceable against Vertex in accordance with its respective terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors rights generally or general equitable principles.
Section 3.03 Governmental and Third Party Authorization.
The execution and delivery by Vertex of the Transaction Documents, and the performance by Vertex of its obligations and the consummation by Vertex of any of the transactions contemplated hereunder and thereunder, do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any Person, except for (i) the filing of proper financing statements under the UCC (ii) the filing of a Current Report on Form 8-K with the Securities and Exchange Commission and (iii) the Janssen Consent. Vertex has obtained prior to its execution and delivery of this Agreement the consent of Janssen required under Section 15.2 of the Janssen Agreement with respect to the assignment and transfer of all of Vertexs right, title and interest in and to the Purchased Interest to the Purchaser and the consummation of the other transactions contemplated by the Transaction Documents (the Janssen Consent), which consent is in full force and effect.
Section 3.04 Ownership.
Vertex is the exclusive owner of the entire right, title (legal and equitable) and interest in and to the Purchased Interest, free and clear of all Liens. Upon the sale, assignment, transfer and conveyance by Vertex of all of its right, title and interest in and to the Purchased Interest to the
10
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Purchaser, the Purchaser will acquire good and marketable title to the Purchased Interest free and clear of all Liens. Upon the filing of an appropriate financing statement with the office of the Secretary of the Commonwealth of The Commonwealth of Massachusetts, there will have been duly filed all financing statements or other similar instruments or documents necessary under the applicable UCC (or any comparable law) of all applicable jurisdictions to perfect and maintain the perfection of the Purchasers ownership interest in the Purchased Interest and of the back-up security interest in the Purchased Interest granted by Vertex to the Purchaser pursuant to Section 2.01(d).
Section 3.05 Solvency.
Upon the sale of the Purchased Interest as contemplated by the Transaction Documents, (i) the fair saleable value of Vertexs assets will be greater than the sum of its debts and other obligations, including contingent liabilities, (ii) the present fair saleable value of Vertexs assets will be greater than the amount that would be required to pay its probable liabilities on its existing debts and other obligations, including contingent liabilities, as they become absolute and matured, (iii) Vertex will be able to realize upon its assets and pay its debts and other obligations, including contingent obligations, as they mature, (iv) Vertex will not have unreasonably small capital with which to engage in its business, and (v) Vertex will not incur, nor does it have present plans or intentions to incur, debts or other obligations or liabilities beyond its ability to pay such debts or other obligations or liabilities as they become absolute and matured.
Section 3.06 No Litigation.
There is no (i) action, suit, arbitration proceeding, claim, investigation or other proceeding (whether civil, criminal, administrative or investigative) pending or, to the Knowledge of Vertex, threatened by or against Vertex or any of its Subsidiaries or, to the Knowledge of Vertex, pending or threatened by or against Janssen, at law or in equity, or (ii) inquiry or investigation (whether civil, criminal, administrative or investigative) by or before a Governmental Authority pending or, to the Knowledge of Vertex, threatened against Vertex or any of its Subsidiaries or, to the Knowledge of Vertex, pending or threatened against Janssen, which, in each case with respect to clause (i) or clause (ii) above, (A) if adversely determined, would reasonably be expected to have, individually or in the aggregate, an Adverse Effect, or (B) challenges, or may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the transactions contemplated by any of the Transaction Documents. To the Knowledge of Vertex, no event has occurred or circumstance exists that may give rise to or serve as a basis for the commencement of any such action, suit, arbitration, claim, investigation, proceeding or inquiry.
Section 3.07 Compliance with Laws.
None of Vertex or any of its Subsidiaries is (i) in violation of, or has violated or has been given notice of any violation, or, to the Knowledge of Vertex, is under investigation with respect to, or has been threatened to be charged with any violation of, any law, rule, ordinance or regulation of, or any judgment, order, writ, decree, permit or license granted, issued or entered by, any Governmental Authority or (ii) subject to any judgment, order, writ, decree, permit or license granted, issued or entered by any Governmental Authority, in the case of both clause (i)
11
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
and clause (ii) above, that would reasonably be expected to have, individually or in the aggregate, an Adverse Effect. To the Knowledge of Vertex, no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would constitute or result in a violation by Vertex or any of its Subsidiaries of, or a failure on the part of Vertex or any of its Subsidiaries to comply with, any such law, rule, ordinance or regulation of, or any judgment, order, writ, decree, permit or license granted, issued or entered by, any Governmental Authority, in each case, that would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
Section 3.08 No Conflicts.
Neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby and thereby will: (i) contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or accelerate the performance provided by, in any respect, (A) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit, authorization or license of any Governmental Authority, to which Vertex or any of its Subsidiaries or any of their respective assets or properties may be subject or bound, (B) any contract, agreement, commitment or instrument to which Vertex or any of its Subsidiaries is a party or by which Vertex or any of its Subsidiaries or any of their respective assets or properties is bound or committed or (C) any provisions of the articles of organization or by-laws (or other organizational or constitutional documents) of Vertex or any of its Subsidiaries; (ii) give rise to any right of termination, cancellation or acceleration of any right or obligation of Vertex or any of its Subsidiaries; (iii) except as provided in the Transaction Documents, result in the creation or imposition of any Lien on the Purchased Interest; or (iv) contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, give to any other Person the right to terminate (provided, however, that neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby and thereby will prevent Janssens ability to terminate the Janssen Agreement under Section 13.2 thereof), or accelerate the performance provided by, in any respect, any provision of the Janssen Agreement; provided, however, that, in the case of clause (i)(B) or clause (ii), such contravention, conflict, breach, violation, default or acceleration would reasonably be expected to result, individually or in the aggregate, in an Adverse Effect.
Section 3.09 Brokers Fees.
Vertex has not taken any action that would entitle any Person other than Morgan Stanley & Co. Incorporated (whose fees shall be paid by Vertex) to any commission or brokers fee in connection with the transactions contemplated by the Transaction Documents.
Section 3.10 Subordination.
The claims and rights of the Purchaser created by any Transaction Document in and to the Purchased Interest are not and shall not, at any time, be subordinated by Vertex to any creditor of Vertex or any other Person or Governmental Authority.
12
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.11 Janssen Agreement.
13
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.12 No Set-offs.
Other than as set forth in Section 9.9 and Section 13.4.1 of the Janssen Agreement, Janssen has no right of Set-off under any contract (including the Janssen Agreement) or other agreement against the Milestone Payment payable to Vertex under the Janssen Agreement. Janssen has not exercised, and, to Vertexs Knowledge, Janssen has not had the right to exercise, and, to Vertexs Knowledge, no event or condition exists that, upon notice or passage of time or
14
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
both, would reasonably be expected to permit Janssen to exercise, any Set-off against the Milestone Payment payable to Vertex under the Janssen Agreement.
Section 3.13 UCC Representations and Warranties.
Section 3.14 Taxes.
No deduction or withholding for or on account of any tax has been made, or was required under applicable law to be made, from any payment to Vertex under the Janssen Agreement.
Section 3.15 Intellectual Property.
15
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 3.16 Certain Information.
Section 3.17 Consolidation.
As of the Effective Date, Vertex does not believe that the Securities and Exchange Commission or GAAP requires Vertex to report its financial results on a consolidated basis with the financial results of the Purchaser as a result of Vertex entering into this Agreement or consummating the transactions contemplated by this Agreement.
16
Information
redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
The Purchaser hereby represents and warrants to Vertex, as of the Effective Date, the following:
Section 4.01 Organization.
The Purchaser is a société anonyme, duly formed, validly existing and in good standing under the laws of the Grand Duchy of Luxembourg. The Purchaser has all necessary powers and all licenses, authorizations, consents and approvals of all Governmental Authorities required to carry on its business as now conducted and to execute and deliver, and perform its obligations under, the Transaction Documents.
Section 4.02 Authorization.
The Purchaser has all necessary power and authority to enter into, execute and deliver the Transaction Documents and to perform all of the obligations of the Purchaser to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder. The Transaction Documents have been, or will be, when executed, duly authorized, executed and delivered by the Purchaser, and each Transaction Document constitutes, or will constitute, when executed, the legal, valid and binding obligation of the Purchaser, enforceable against the Purchaser in accordance with its respective terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors rights generally or general equitable principles.
Section 4.03 Governmental and Third Party Authorization.
The execution and delivery by the Purchaser of the Transaction Documents, and the performance by the Purchaser of its obligations and the consummation of any of the transactions contemplated hereunder and thereunder, do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any other Person.
Section 4.04 No Litigation.
There is no (i) action, suit, arbitration proceeding, claim, investigation or other proceeding (whether civil, criminal, administrative or investigative) pending, or, to the knowledge of the Purchaser, threatened by or against the Purchaser, at law or in equity, or (ii) inquiry or investigation (whether civil, criminal, administrative or investigative) by or before a Governmental Authority pending or, to the knowledge of the Purchaser, threatened against the Purchaser, which, in each case with respect to clause (i) or clause (ii) above, (A) if adversely determined would reasonably be expected to have, individually or in the aggregate, a material adverse effect on (x) the right or ability of the Purchaser to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder or (y) the rights or remedies of Vertex and its Affiliates under any of the Transaction Documents, or an adverse effect on the legality, validity or enforceability of any of the
17
Information redacted pursuant to a
confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Transaction Documents, (B) challenges, or may have the effect of preventing, delaying, making illegal or otherwise interfering with, any of the transactions contemplated by any of the Transaction Documents.
Section 4.05 No Conflicts.
Neither the execution and delivery of any of the Transaction Documents nor the performance or consummation of the transactions contemplated hereby or thereby will contravene, conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or accelerate the performance provided by, in any respect, (i) any statute, law, rule, ordinance or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit or license of any Governmental Authority, to which the Purchaser or any of its assets or properties may be subject or bound, (ii) any contract, agreement, commitment or instrument to which the Purchaser is a party or by which the Purchaser or any of its assets or properties is bound or committed or (iii) any provisions of the organizational or constitutional documents of the Purchaser, except in the case of clause (ii) above, as would not reasonably be expected to have, individually or in the aggregate, a material adverse effect on the right or ability of the Purchaser to perform any of its obligations under any of the Transaction Documents or to consummate the transactions contemplated hereunder or thereunder.
Section 4.06 Brokers Fees.
The Purchaser has not taken any action that would entitle any Person to any commission or brokers fee in connection with the transactions contemplated by the Transaction Documents.
Section 4.07 Access to Information.
The Purchaser acknowledges that it has (i) reviewed a redacted copy of the Janssen Agreement (with, for the avoidance of doubt, the Ancillary Janssen Documents redacted) and the Report (in reliance on the representations and warranties of Vertex set forth herein, including Section 3.11(b)) and (ii) had the opportunity to ask questions of, and to receive answers from, representatives of Vertex concerning the Janssen Agreement and the Milestone Payment. The Purchaser has such knowledge, sophistication and experience in financial and business matters that it is capable of evaluating the risks and merits of purchasing, acquiring and accepting the Purchased Interest in accordance with the terms of this Agreement. The Purchaser acknowledges and agrees that (i) the Report was furnished to the Purchaser by Vertex for the Purchasers convenience, (ii) the Report was not prepared by Vertex, (iii) Vertex did not, and does not, adopt or endorse the contents of the Report, (iv) the Report constitutes the work product solely of L.E.K. Consulting LLC and (v) Vertex disclaims any representation, either express or implied, that the information in the Report is accurate or that the statements in the Report coincide with Vertexs views.
The parties hereto covenant and agree as follows:
18
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.01 Confidentiality; Public Announcement.
19
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.02 Further Assurances.
The Purchaser and Vertex agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be necessary or desirable, or reasonably requested by the other party hereto, in each case at the expense of the Purchaser, in order to vest and maintain in the Purchaser good and marketable title in and to the Purchased Interest free and clear of all Liens, including the perfection and maintenance of perfection of the Purchasers ownership interest in the Purchased Interest and of the back-up security interest in the Purchased Interest granted by Vertex to the Purchaser pursuant to Section 2.01(d).
Section 5.03 Payments to Vertex on Account of the Purchased Interest.
Section 5.04 Janssen Agreement.
20
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 5.05 Termination of the Janssen Agreement.
Section 5.06 Notice of Certain Events.
Section 5.07 Access to Certain Information.
21
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
(b) Vertex agrees that the Purchaser shall have no liability (whether direct or indirect, in contract or tort or otherwise) to any Vertex Indemnified Party for or in connection with any of the financial records or financial information provided by the Purchaser pursuant to Section 5.07(a) hereof except for Losses incurred by Vertex that are finally judicially determined to have resulted from actual fraud, gross negligence or willful misconduct on the part of the Purchaser.
Section 6.01 Termination Date.
This Agreement shall terminate on the date upon which the earlier of the following occurs: (i) the payment to the Purchaser of the Milestone Payment in full pursuant to the terms of the Transaction Documents; (ii) the expiration of the Janssen Agreement; or (iii) the termination of the Janssen Agreement where licenses granted to Janssen under Article 7 of the Janssen Agreement terminate.
Section 6.02 Effect of Termination.
In the event of the termination of this Agreement pursuant to Section 6.01, this Agreement shall become void and of no further force and effect, except for: (i) those rights and obligations that have accrued prior to the date of such termination, including the payment in accordance with the terms hereof of the Milestone Payment earned prior the date of such termination; (ii) in the event of termination of this Agreement pursuant to Section 6.01(iii), the right to payment of the Milestone Payment under Section 5.05, and Section 5.03, and Section 5.04(b); and (iii) Article I, Article VI and Article VII and Section 2.02(b) (but only the last sentence thereof), Section 5.01, and Section 5.07 (but only for the period ending 45 days after the end of the calendar quarter in which such termination occurred), shall survive the termination of this Agreement and there shall be no liability on the part of any party hereto, any of its Affiliates or controlling Persons or any of their respective officers, directors, shareholders, members, partners, controlling Persons, managers, agents or employees, other than as provided for in this Section 6.02. Nothing contained in this Section 6.02 shall relieve any party hereto from liability for any breach of this Agreement that occurs prior to such termination.
22
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.01 Survival.
All representations and warranties made herein and in any other Transaction Document or any certificates delivered pursuant to this Agreement shall survive the execution and delivery of this Agreement and shall continue to survive until October 31, 2012; provided, however, that the representations and warranties contained in Sections 3.08 and 3.11 shall survive until the date that is one year after termination of this Agreement; provided, further, however, that the representations and warranties contained in Sections 3.01, 3.02, 3.03, 3.04, 3.09, 3.10, 3.12 and 3.14 shall survive indefinitely; provided, further, however, that it is understood and agreed that, notwithstanding the survival provisions of this Section 7.01, all of the representations and warranties made by the parties hereto are made only as of the Effective Date. The obligations of (a) Vertex to indemnify and hold harmless any Purchaser Indemnified Party under Section 7.05 and (b) the Purchaser to indemnify and hold harmless any Vertex Indemnified Party under Section 7.05, in each case shall terminate (i) when the applicable representation or warranty terminates pursuant to this Section 7.01, with respect to claims made pursuant to Error! Reference source not found. and Error! Reference source not found., as applicable, and (ii) 60 days after the expiration of the applicable statute of limitations (or waivers or extensions thereof), with respect to claims made pursuant to Error! Reference source not found., Error! Reference source not found., Error! Reference source not found. or 7.05(b)(iv); provided, however, that, in each case, such obligations to indemnify and hold harmless shall not terminate with respect to any item as to which a Purchaser Indemnified Party or a Vertex Indemnified Party shall have, before the expiration of the applicable period, previously notified the indemnifying party pursuant to Section 7.05.
Section 7.02 Specific Performance.
Each of the parties hereto acknowledges that the other party hereto may have no adequate remedy at law if it fails to perform any of its obligations under any of the Transaction Documents. In such event, each of the parties hereto agrees that the other party hereto shall have the right, in addition to any other rights it may have (whether at law or in equity), to specific performance of this Agreement. Neither party hereto shall have any right to terminate this Agreement or any other Transaction Document as a result of any breach by the other party hereto hereof or thereof, but instead shall have the rights set forth in this Agreement, including this Article VII.
Section 7.03 Notices.
All notices, consents, waivers and communications hereunder given by any party hereto to the other party hereto shall be in writing, signed by the party hereto giving such notice and be deemed to have been duly given when (i) delivered by hand, (ii) sent by facsimile (with written confirmation of receipt) if sent during regular business hours on a Business Day (and, if not, then on the next succeeding Business Day), provided, however, that a copy is mailed by registered
23
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
mail, return receipt requested, (iii) received by the addressee, if sent by nationally recognized overnight delivery service (receipt requested), or (iv) sent by email if sent during regular business hours on a Business Day (and, if not, then on the next succeeding Business Day), provided, however, that a copy is mailed by a nationally recognized overnight delivery service (provided, however, that delivery will not be deemed effective unless the addressee provides written confirmation of receipt by facsimile or return email (automatic email responses do not constitute confirmation)), in each case, to the applicable addresses, facsimile numbers and/or email addresses set forth below:
If to the Purchaser to:
Olmsted Park S.A.
20, rue de la Poste
L-2346 Luxembourg
Attention: Board of Directors
with a copy (which shall not constitute notice) to:
Akin Gump Strauss Hauer & Feld LLP
One Bryant Park
New York, NY 10036
Attention: Stuart E. Leblang
Facsimile: (212) 872-1002
Email: sleblang@akingump.com
If to Vertex to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Philippe Tinmouth
Head, Business Development & Licensing
Facsimile: 617-444-6632
Email: phil_tinmouth@vrtx.com
with a copy (which shall not constitute notice) to:
Vertex Pharmaceuticals
Incorporated
130 Waverly Street
Cambridge, MA 02139
Attention: Kenneth S. Boger, Esq.
Senior Vice President and General Counsel
Facsimile: 617-444-7117
Email: ken_boger@vrtx.com
24
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
or to such other address or addresses, facsimile number or numbers or email address or addresses as the Purchaser or Vertex may from time to time designate by notice as provided herein, except that notices of such changes shall be effective only upon receipt.
Section 7.04 Successors and Assigns.
The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. Neither party shall be entitled to assign, directly or indirectly, any of its obligations and rights under any of the Transaction Documents, including by operation of law or otherwise, without the prior written consent of the other party; provided, however, that (i) Vertex may, without the consent of the Purchaser, assign any of its obligations or rights under the Transaction Documents to any other Person with which it may merge or consolidate or to which it may sell all or substantially all of its assets, provided that the assignee under such assignment agrees to be bound by the terms of the Transaction Documents and furnishes a written agreement to the Purchaser in form and substance reasonably satisfactory to the Purchaser to that effect, and (ii) Purchaser may assign this Agreement in its entirety without the consent of Vertex, provided, however, that the Purchaser shall give notice of any such assignment to Vertex after the occurrence thereof. Vertex shall be under no obligation to reaffirm any representations, warranties or covenants made in this Agreement or any of the other Transaction Documents or take any other action in connection with any such assignment by the Purchaser.
Section 7.05 Indemnification.
25
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
26
Information redacted pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.06 Independent Nature of Relationship.
27
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.07 Tax.
28
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
29
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.08 Entire Agreement.
This Agreement, together with the Schedule and Exhibits hereto (which are incorporated herein by reference), and the other Transaction Documents constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior agreements, understandings and negotiations, both written and oral, between the parties hereto with respect to the subject matter of this Agreement. No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Schedule, Exhibits or other Transaction Documents) has been made or relied upon by either party hereto. Neither this Agreement, nor any provision hereof, is intended to confer upon any Person other than the parties hereto any rights or remedies hereunder.
Section 7.09 Governing Law.
30
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.10 Waiver of Jury Trial.
EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HERETO HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT THE OTHER PARTY HERETO WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.10.
Section 7.11 Severability.
If one or more provisions of this Agreement are held to be invalid or unenforceable by a court of competent jurisdiction, such provision shall be excluded from this Agreement and the balance of this Agreement shall be interpreted as if such provision were so excluded and shall remain in full force and effect and be enforceable in accordance with its terms. Any provision of this Agreement held invalid or unenforceable only in part or degree by a court of competent jurisdiction shall remain in full force and effect to the extent not held invalid or unenforceable.
31
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.12 Counterparts; Effectiveness.
This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each party hereto shall have received a counterpart hereof signed by the other party hereto. Any counterpart may be executed by facsimile signature and such facsimile signature shall be deemed an original.
Section 7.13 Amendments; No Waivers.
Section 7.14 Interpretation.
32
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
Section 7.15 Expenses.
Each of the parties hereto shall pay all of their own fees and expenses incurred in connection with the negotiation of and entering into, this Agreement and the other Transaction Documents, and the consummation of the transactions contemplated hereby and thereby.
[Signature page follows]
33
Information redacted pursuant to
a confidential treatment request. An
unredacted version
of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective authorized officers as of the date first above written.
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VERTEX PHARMACEUTICALS INCORPORATED |
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By: |
/s/ Matthew W. Emmens |
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Name: |
Matthew W. Emmens |
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Title: |
Chairman, President and CEO |
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OLMSTED PARK S.A. |
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By: |
/s/ Julia Vogelweith |
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Name: |
Julia Vogelweith |
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Title: |
Director |
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By: |
/s/ Hille-Paul Schut |
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Name: |
Hille-Paul Schut |
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Title: |
Director |
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By: |
/s/ Xavier de Cillia |
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Name: |
Xavier de Cillia |
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Title: |
Director |
CERTIFICATION
I, Matthew W. Emmens, certify that:
Date: November 9, 2009 | /s/ MATTHEW W. EMMENS Matthew W. Emmens Chairman, Chief Executive Officer and President (principal executive officer) |
CERTIFICATION
I, Ian F. Smith, certify that:
Date: November 9, 2009 | /s/ IAN F. SMITH Ian F. Smith Executive Vice President and Chief Financial Officer (principal financial officer) |
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350,
Chapter 63 of Title 18, United States Code)
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (the "Company"), does hereby certify, to such officer's knowledge, that the Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 (the "Form 10-Q") of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 9, 2009 | /s/ MATTHEW W. EMMENS Matthew W. Emmens Chairman, Chief Executive Officer and President (principal executive officer) |
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Dated: November 9, 2009 |
/s/ IAN F. SMITH Ian F. Smith Executive Vice President and Chief Financial Officer (principal financial officer) |