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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


FORM 10-Q

 


 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2006

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from             to

Commission File No. 0-19731

 


GILEAD SCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 


 

Delaware   94-3047598

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

333 Lakeside Drive, Foster City, California   94404
(Address of principal executive offices)   (Zip Code)

650-574-3000

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   x     No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. (Check one):

 

Large accelerated filer  x

  Accelerated filer  ¨   Non-accelerated filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨     No   x

Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of October 31, 2006: 459,826,913

 



Table of Contents

GILEAD SCIENCES, INC.

INDEX

 

PART I.   FINANCIAL INFORMATION   
  Item 1.   Condensed Consolidated Financial Statements:   
    Condensed Consolidated Balance Sheets at September 30, 2006 and December 31, 2005    3
    Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2006 and 2005    4
    Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2006 and 2005    5
    Notes to Condensed Consolidated Financial Statements    6
  Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations    20
  Item 3.   Quantitative and Qualitative Disclosures About Market Risk    31
  Item 4.   Controls and Procedures    31
PART II.   OTHER INFORMATION   
  Item 1.   Legal Proceedings    31
  Item 1A.   Risk Factors    31
  Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds    38
  Item 4.   Submission of Matters to a Vote of Security Holders    38
  Item 5.   Other Information    38
  Item 6.   Exhibits    39
SIGNATURES      40

We own or have rights to various trademarks, copyrights and trade names used in our business including the following: GILEAD SCIENCES ® , AMBISOME ® , DAUNOXOME ® , EMTRIVA ® , HEPSERA ® , TRUVADA ® , VIREAD ® and VISTIDE ® . ATRIPLA TM is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. MACUGEN ® is a registered trademark belonging to OSI Pharmaceuticals, Inc. SUSTIVA ® is a registered trademark and BARACLUDE TM is a trademark of Bristol-Myers Squibb Company. TAMIFLU ® is a registered trademark belonging to F. Hoffmann-La Roche Ltd. This report also includes other trademarks, service marks and trade names of other companies.

 

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PART I. FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

 

     September 30,
2006
   December 31,
2005
 
     (unaudited)    (1)  

Assets

     

Current assets:

     

Cash and cash equivalents

   $ 559,580    $ 707,913  

Short-term marketable securities

     2,294,368      1,603,120  

Accounts receivable, net

     585,050      396,125  

Inventories

     373,266      216,903  

Deferred tax assets

     113,602      84,839  

Prepaid expenses

     44,396      48,383  

Other current assets

     62,138      34,925  
               

Total current assets

     4,032,400      3,092,208  

Property, plant and equipment, net

     288,105      242,568  

Noncurrent portion of prepaid royalties

     321,777      333,582  

Noncurrent deferred tax assets

     239,644      66,893  

Long-term marketable securities

     350,495      —    

Minority interest in joint venture

     1,869      1,665  

Other noncurrent assets

     64,842      29,400  
               
   $     5,299,132    $     3,766,316  
               

Liabilities and stockholders’ equity

     

Current liabilities:

     

Accounts payable

   $ 207,806    $ 70,908  

Accrued clinical and preclinical expenses

     10,237      10,514  

Accrued compensation and employee benefits

     65,919      59,927  

Income taxes payable

     —        95,739  

Other accrued liabilities

     220,995      149,516  

Deferred revenue

     16,757      18,353  

Current portion of other long-term obligations

     60,115      60,206  
               

Total current liabilities

     581,829      465,163  

Long-term deferred revenue

     38,052      32,725  

Convertible senior notes

     1,300,000      —    

Other long-term obligations

     80,421      240,650  

Commitments and contingencies

     

Stockholders’ equity:

     

Common stock, par value $0.001 per share; 1,400,000 shares authorized; 458,789 and 459,726 shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively

     459      460  

Additional paid-in capital

     2,518,025      2,206,228  

Accumulated other comprehensive income

     6,062      11,578  

Deferred stock compensation

     —        (130 )

Retained earnings

     774,284      809,642  
               

Total stockholders’ equity

     3,298,830      3,027,778  
               
   $ 5,299,132    $ 3,766,316  
               

(1) The condensed consolidated balance sheet at December 31, 2005 has been derived from audited consolidated financial statements at that date but does not include all of the information and footnotes required by United States generally accepted accounting principles for complete financial statements.

See accompanying notes.

 

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GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

 

    

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
             2006                     2005             2006     2005  

Revenues:

        

Product sales

   $     670,060     $     467,204     $     1,820,104     $     1,315,873  

Royalty and contract revenue

     78,673       26,247       306,809       103,261  
                                

Total revenues

     748,733       493,451       2,126,913       1,419,134  
                                

Costs and expenses:

        

Cost of goods sold

     109,791       65,498       278,031       186,182  

Research and development

     93,305       78,830       272,241       208,961  

Selling, general and administrative

     132,529       100,873       426,567       274,765  

Purchased in-process research and development

     355,568       —         355,568       —    
                                

Total costs and expenses

     691,193       245,201       1,332,407       669,908  
                                

Income from operations

     57,540       248,250       794,506       749,226  

Interest and other income, net

     36,197       14,127       102,082       31,232  

Interest expense

     (6,081 )     (26 )     (15,012 )     (50 )

Minority interest in joint venture

     1,640       1,223       3,878       2,398  
                                

Income before provision for income taxes

     89,296       263,574       885,454       782,806  

Provision for income taxes

     141,460       84,342       409,764       250,494  
                                

Net income (loss)

   $ (52,164 )   $ 179,232     $ 475,690     $ 532,312  
                                

Net income (loss) per share – basic

   $ (0.11 )   $ 0.39     $ 1.04     $ 1.18  
                                

Net income (loss) per share – diluted

   $ (0.11 )   $ 0.38     $ 0.99     $ 1.13  
                                

Shares used in per share calculation – basic

     457,433       456,098       458,773       452,923  
                                

Shares used in per share calculation – diluted

     457,433       475,965       478,101       472,350  
                                

See accompanying notes.

 

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GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

    

Nine Months Ended

September 30,

 
     2006     2005  

OPERATING ACTIVITIES:

    

Net income

   $ 475,690     $ 532,312  

Adjustments to reconcile net income to net cash provided by operating activities:

    

Depreciation and amortization

     35,517       23,904  

Purchased in-process research and development

     355,568       —    

Stock-based compensation expense

     98,144       898  

Tax benefits from employee stock plans

     107,496       79,000  

Excess tax benefits from stock-based compensation

     (79,779 )     —    

Deferred income taxes

     (271 )     67,914  

Asset impairment

     8,230       —    

Write-down of inventory

     6,820       —    

Minority interest in joint venture

     (204 )     (1,465 )

Other-than-temporary loss on marketable securities

     6,617       —    

Other non-cash transactions

     13,621       (59 )

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (177,570 )     3,492  

Inventories

     (160,826 )     (38,049 )

Prepaid expenses and other assets

     (16,797 )     (2,093 )

Prepaid royalties

     —         (341,250 )

Accounts payable

     136,880       (14,418 )

Income taxes payable

     (95,739 )     (1,859 )

Accrued liabilities

     21,423       66,961  

Deferred revenue

     3,731       (5,996 )
                

Net cash provided by operating activities

     738,551       369,292  

INVESTING ACTIVITIES:

    

Purchases of marketable securities

     (2,292,355 )     (1,143,800 )

Proceeds from sales of marketable securities

     886,472       610,765  

Proceeds from maturities of marketable securities

     366,869       368,477  

Acquisition of Corus net assets, net of cash acquired

     (356,167 )     —    

Purchases of non-marketable equity securities

     (31,688 )     —    

Capital expenditures and other

     (74,995 )     (34,909 )
                

Net cash used in investing activities

     (1,501,864 )     (199,467 )

FINANCING ACTIVITIES:

    

Proceeds from issuances of common stock

     123,824       107,157  

Proceeds from issuance of convertible senior notes, net of issuance costs

     1,276,242       —    

Proceeds from sale of warrants

     235,495       —    

Purchases of convertible note hedges

     (379,145 )     —    

Repurchases of common stock

     (544,943 )     —    

Repayments of long-term debt and other obligations

     (161,418 )     (166 )

Excess tax benefits from stock-based compensation

     79,779       —    
                

Net cash provided by financing activities

     629,834       106,991  

Effect of exchange rate changes on cash

     (14,854 )     (39,127 )
                

Net increase (decrease) in cash and cash equivalents

     (148,333 )     237,689  

Cash and cash equivalents at beginning of period

     707,913       280,909  
                

Cash and cash equivalents at end of period

   $ 559,580     $ 518,598  
                

See accompanying notes.

 

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GILEAD SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2006

(unaudited)

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of Gilead Sciences, Inc. (Gilead, the Company or we) believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or for any subsequent interim period.

Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an on-going basis, management evaluates its estimates, including those related to revenue recognition, allowance for doubtful accounts, inventories, prepaid royalties, clinical trial accruals, income tax provision and stock-based compensation. Actual results may differ from these estimates. The accompanying Condensed Consolidated Financial Statements include the accounts of the Company, its wholly-owned subsidiaries and its joint venture with Bristol-Myers Squibb Company (BMS), of which Gilead is the primary beneficiary as determined under Financial Accounting Standards Board (FASB) Interpretation No. 46, Consolidation of Variable Interest Entities (FIN 46R). Minority interest is recorded for BMS’s interest in the joint venture. Significant intercompany transactions have been eliminated.

On January 1, 2006, we began reporting net foreign exchange transaction gains or losses as well as fair value changes on derivative instruments not designated as hedges in interest and other income, net, in our Condensed Consolidated Statements of Operations. The amounts of $1.6 million and $(0.2) million for the three and nine months ended September 30, 2005, respectively, which were previously reported as selling, general and administrative (SG&A) expenses, were reclassified to conform to the current period presentation. Additionally in 2006, we began classifying interest receivable related to our marketable securities in other current assets in our Condensed Consolidated Balance Sheets. This reclassification had the effect of increasing other current assets and decreasing marketable securities by $12.9 million as of December 31, 2005. On our Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2005, this reclassification had the effect of decreasing net cash used in investing activities and decreasing net cash provided by operating activities by $5.3 million. This reclassification did not affect our Condensed Consolidated Statements of Operations.

As a result of our issuance of the convertible senior notes and related transactions in April 2006 (see Note 9), our cash, cash equivalents and marketable securities increased significantly. When the net proceeds from these transactions were considered together with our existing cash, cash equivalents, marketable securities and our credit facility (see Note 9), our ability to hold our long-term marketable securities until their respective maturities was significantly enhanced. Accordingly, during the quarter ended June 30, 2006, we began classifying our marketable securities portfolio as short-term or long-term according to their contractual maturities.

The accompanying financial information should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2005, included in our Annual Report on Form 10-K as filed with the Securities and Exchange Commission (SEC).

Recent Accounting Pronouncements

In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48), an interpretation of Statement of Financial Accounting Standards (SFAS) No. 109, Accounting for Income Taxes (SFAS 109). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS 109 and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. FIN 48 will be effective beginning with the first fiscal period after December 15, 2006. We are still evaluating what impact, if any, the adoption of this standard will have on our consolidated financial statements.

Revenue Recognition

Product Sales

We recognize revenue from product sales when there is persuasive evidence an arrangement exists, delivery to the customer has occurred, the price is fixed or determinable and collectibility is reasonably assured. Upon recognition of revenue from product sales, provisions are made for government rebates, customer incentives such as cash discounts for prompt payment, certain distributor fees and estimated future returns of products that may expire.

 

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Items Deducted from Gross Product Sales:

Government Rebates

We estimate amounts payable by us to government-managed Medicaid programs as well as to certain other qualifying federal and state government programs based on contractual terms, historical utilization rates, any new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates for these programs and channel inventory data as obtained from our major U.S. wholesalers in accordance with our inventory management agreements. Government rebates that are invoiced directly to us are recorded in other accrued liabilities in our condensed consolidated balance sheets. For qualified programs that can purchase our products through wholesalers at a lower contractual government price, the wholesalers charge back to us the difference between their acquisition cost and the lower price, which we record as allowances against accounts receivable.

Cash Discounts

We estimate cash discounts based on contractual terms, historical utilization rates and our expectations regarding future utilization rates.

Distributor Fees

Under our inventory management agreements with our significant U.S. wholesalers, we pay the wholesalers a fee primarily for the compliance of certain contractually-determined covenants such as the maintenance of agreed-upon inventory levels. These distributor fees are based on a contractually-determined fixed percentage of sales.

Product Returns

We do not provide our customers with a general right of product return but permit returns if the product is damaged or defective when received by the customer, or if the product in the Unites States has expired. We will accept product returns in the United States that have expired for one year after their expiration. Our estimates for expected returns of expired products are based primarily on an on-going analysis of historical return patterns.

Contract Revenue

Contract revenue for research and development (R&D) is recorded as performance occurs and the earnings process is completed based on the performance requirements of the contract. Nonrefundable contract fees for which no further performance obligations exist, and where there is no continuing involvement by Gilead, are recognized on the earlier to occur of when the payments are received or when collection is reasonably assured.

Revenue from non-refundable up-front license fees and milestone payments where we continue to have involvement such as through a development collaboration or an obligation to supply product is recognized as performance occurs and our obligations are completed. In accordance with the specific terms of Gilead’s obligations under these types of arrangements, revenue is recognized as the obligation is fulfilled or ratably over the development or manufacturing period. Revenue associated with substantive at-risk milestones is recognized based upon the achievement of the milestones as defined in the respective agreements. Advance payments received in excess of amounts earned are classified as deferred revenue.

Royalty Revenue

Royalty revenue from sales of AmBisome ® (amphotericin B liposome for injection) is recognized in the month following the month in which the corresponding sales occur. Royalty revenue from sales of our other products is recognized when received, which is in the quarter following the quarter in which the corresponding sales occur.

 

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Earnings Per Share

Basic earnings per share is calculated based on the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per share is calculated based on the weighted-average number of shares of common stock and other dilutive securities outstanding during the period. Potential dilutive shares of common stock resulting from the assumed exercise of outstanding stock options and equivalents, the assumed conversion of our convertible senior notes due in 2011 (2011 Notes) and our convertible senior notes due in 2013 (2013 Notes) (collectively, the Notes) and the assumed exercise of the warrants relating to the Notes are determined under the treasury stock method.

The following table is a reconciliation of the numerator and denominator used in the calculation of basic and diluted earnings per share (in thousands):

 

    

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

     2006     2005    2006    2005

Numerator:

          

Net income (loss)

   $     (52,164 )   $     179,232    $     475,690    $     532,312
                            

Denominator:

          

Weighted-average shares of common stock outstanding used in calculation of basic earnings per share

     457,433       456,098      458,773      452,923

Effect of dilutive securities:

          

Stock options and equivalents

     —         19,867      19,328      19,427
                            

Weighted-average shares of common stock outstanding used in calculation of diluted earnings (loss) per share

     457,433       475,965      478,101      472,350
                            

Options to purchase approximately 7.7 million and 6.8 million shares of common stock were also outstanding during the three and nine months ended September 30, 2006, respectively, but were not included in the computation of diluted earnings (loss) per share because the options’ exercise prices were greater than the average market price of our common stock during these periods; therefore, their effect was antidilutive. Additionally, options and equivalents to purchase approximately 18.8 million shares of common stock were also outstanding during the three months ended September 30, 2006 but were not included in the computation of diluted earnings per share because their effect was antidilutive as we reported a net loss. In addition, due to the inclusion of the restrictions on conversion under our Notes, our diluted earnings (loss) per share computation will not give effect to the dilution from the conversion of the Notes until the share price of our common stock exceeds $77.50 and $76.20 for the 2011 Notes and 2013 Notes, respectively. Options to purchase approximately 0.3 million and 0.5 million shares of common stock were outstanding during the three and nine months ended September 30, 2005, respectively, but were not included in the computation of diluted earnings per share because the options’ exercise prices were greater than the average market price of our common stock during these periods; therefore, their effect was antidilutive.

Stock-Based Compensation

In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS 123R), a revision of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), which requires that all share-based payments to employees and directors, including grants of stock options, be recognized in the income statement based on their fair values, beginning with the first quarterly period of the first fiscal year beginning on or after June 15, 2005, with early adoption permitted. SFAS 123R also requires the benefit of tax deductions in excess of recognized compensation cost to be reported in the statement of cash flows as a financing cash flow, rather than as an operating cash flow. SFAS 123R supersedes Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) and amends SFAS No. 95, Statement of Cash Flows . On January 1, 2006, we adopted SFAS 123R using the modified prospective method, one of the adoption methods permitted under SFAS 123R (see Note 11).

2. INVENTORIES

Inventories are summarized as follows (in thousands):

 

     September 30, 2006    December 31, 2005

Raw materials

   $     179,623    $     147,950

Work in process

     56,968      25,061

Finished goods

     136,675      43,892
             

Total inventories

   $ 373,266    $ 216,903
             

 

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Our inventory balance as of September 30, 2006 and December 31, 2005 included Sustiva ® (efavirenz) active pharmaceutical ingredient (API) which we purchased from BMS at BMS’s approximate market value of Sustiva. As of September 30, 2006, the joint venture formed by Gilead and BMS held approximately $63.7 million of Sustiva API which it purchased from BMS at BMS’s estimated net selling price of Sustiva in the U.S. market and included in raw materials inventory, as well as $9.2 million and $60.8 million of Sustiva API included in work-in-process inventory and finished goods inventory, respectively.

During the first quarter of 2006, based on our regular evaluation of forecasted sales and existing pricing, we concluded that we would not fully recover the capitalized manufacturing costs associated with the inventory for our Gilead Access Program. As a result, we recorded $6.8 million in cost of goods sold to write down this inventory to its estimated net realizable value.

3. ASSET DISPOSAL

In March 2006, we received local city approval to proceed with the demolition of two of our owned buildings in Foster City, California, and to begin construction of new facilities. We included the charge associated with the write-off of these buildings, equal to their aggregate net book value of $7.9 million, in SG&A expenses during the first quarter of 2006.

4. ACQUISITION OF REAL ESTATE

In August 2006, we completed the purchase of two additional buildings located on our Foster City, California campus for an aggregate of approximately $29.3 million. The purchase price was allocated between land, buildings and land improvements based on their estimated relative fair values determined by management, based in part on an independent appraisal, which were $13.7 million, $14.6 million and $0.9 million, respectively. The fair value of the buildings and land improvements are being depreciated over their remaining economic life estimated to be 20 years.

5. EUROPEAN HEADQUARTERS RELOCATION

In June 2005, we announced that the commercial, medical and administrative groups of our European headquarters, based in Paris, France, would be relocated to the London area in the United Kingdom to be closer to our European headquarters for our regulatory, safety and information technology groups already located in the Cambridge area in the United Kingdom. We believe that this relocation will enable us to achieve efficiencies through the closer proximity of the groups as we position our company to compete with the large pharmaceutical companies at a global level. Our French subsidiary continues to occupy our existing Paris facilities as we continue to expand our sales and marketing presence in France.

In the third quarter of 2005, when the relocation plans were finalized, we accrued a charge of $8.4 million, primarily consisting of employee severance costs and termination benefits, which was included in SG&A expenses. As of September 30, 2006, $6.3 million of these severance costs and termination benefits have been incurred, thereby reducing the relocation accrual that is included in accrued compensation and employee benefits in the Condensed Consolidated Balance Sheets to $2.1 million. Additional costs relating to the new headquarters in the United Kingdom, including recruitment costs, legal expenses, capital expenditures and other related costs are being expensed as incurred. Based upon the most current information available, we believe that the aggregate severance, relocation and recruiting costs resulting from the relocation of our European headquarters continues to be in the range of $10 million to $13 million.

6. COLLABORATIVE ARRANGEMENTS AND CONTRACTS

As a result of entering into strategic collaborations from time to time, we may hold investments in non-public companies. We record these nonmarketable equity securities at cost in other noncurrent assets, less any amounts for other-than-temporary impairment. We regularly review these investments for indicators of impairment. We also review our interests in our investee companies for consolidation and/or appropriate disclosure under the provisions of FIN 46R. As of September 30, 2006, we determined that certain of our investee companies are variable interest entities; however, other than with respect to our joint venture with BMS, we are not the primary beneficiary. Accordingly, we have conformed our disclosures with this determination.

Japan Tobacco

In March 2005, we entered into a licensing agreement with Japan Tobacco Inc. (Japan Tobacco), under which Japan Tobacco granted Gilead exclusive rights to develop and commercialize a novel HIV integrase inhibitor, GS 9137 (formerly called JTK-303), in all countries of the world, excluding Japan, where Japan Tobacco will retain such rights. Under the terms of the agreement, we incurred an upfront license fee of $15.0 million which was included in R&D expenses in the first quarter of 2005 as there was no future alternative use for this technology. In March 2006, we recorded $5.0 million in R&D expenses related to a milestone we incurred as a result of dosing the first patient in a Phase 2 clinical study as there was no future alternative use for this technology. We are obligated to make additional payments upon the achievement of other milestones as well as pay royalties based on any future net product sales in the territories where we may market the drug.

 

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GlaxoSmithKline

In April 2002, Gilead and GlaxoSmithKline (GSK) entered into a licensing agreement providing GSK the rights to commercialize Hepsera ® (adefovir dipivoxil), our oral antiviral for the treatment of chronic hepatitis B, in Asia, Latin America and certain other territories. Under the agreement, we retained rights to Hepsera in the United States, Canada, Eastern and Western Europe, Australia, New Zealand and Turkey. GSK received exclusive rights to develop Hepsera solely for the treatment of chronic hepatitis B in all of its territories, the most significant of which include China, Japan, Korea and Taiwan. We received a $2.0 million milestone payment from GSK for the U.S. approval of Hepsera in 2002, $2.0 million for the Canadian approval of Hepsera in 2003, and an aggregate of $13.0 million for the commercial approvals of Hepsera in Japan, South Korea and Taiwan in 2004. During the third quarter of 2006, we received a $5.0 million milestone payment from GSK for the achievement by GSK of four consecutive quarters of Hepsera gross sales exceeding $75.0 million. GSK has full responsibility for development and commercialization of Hepsera in its territories. The up-front license fee and milestones have all been recorded as deferred revenue to be amortized into contract revenue over the remaining period of our supply of Hepsera to GSK under the agreement, which is approximately 9 years.

OSI Pharmaceuticals, Inc.

In March 2000, we entered into an agreement with Eyetech Pharmaceuticals, Inc., which was acquired by OSI Pharmaceuticals, Inc. (OSI) in 2005, relating to Macugen ® (pegaptanib sodium injection). Macugen is an inhibitor of vascular endothelial growth factor, or VEGF, which is known to play a role in the development of certain ophthalmic diseases. Under the terms of the agreement, OSI received worldwide rights to all therapeutic uses of Macugen and was responsible for all R&D costs. We are entitled to receive payments from OSI if OSI reaches certain milestones as well as for royalties on worldwide net sales of Macugen, subject to our obligation to make payments to third parties relating to these royalties. In February 2006, Macugen was approved in the European Union, and in June 2006, we recognized a $5.0 million milestone payment from OSI relating to the first commercial sale of Macugen in the European Union which was included in contract revenue.

7. ACQUISITIONS

Corus Pharma, Inc.

On August 11, 2006, we completed the acquisition of Corus Pharma, Inc. (Corus), a privately held biopharmaceutical company based in Seattle, Washington. Corus was a development stage company that focused on the development and commercialization of novel drugs for respiratory and infectious diseases. Corus has one lead product candidate in late-stage clinical trials and two early-stage product candidates. This acquisition provides us with an opportunity to expand into new therapeutic areas such as respiratory diseases and augments our existing pipeline.

The Corus acquisition has been accounted for as an acquisition of assets rather than as a business combination in accordance with the criteria outlined in Emerging Issues Task Force (EITF) Issue No. 98-3, Determining Whether a Nonmonetary Transaction Involves Receipt of Productive Assets or of a Business . Corus was considered a development stage company because it had not commenced its planned principal operations. Additionally, it lacked all the necessary elements of a business, including not having a completed product and, therefore, no ability to access customers. The results of operations of Corus since August 11, 2006 have been included in our condensed consolidated statements or operations and primarily consist of research and development expenses and to a lesser extent, SG&A expenses.

In April 2006, we purchased $25.0 million of Corus’s Series C preferred stock, which represented approximately 15% of Corus’s voting equity interests at the time. In conjunction with the purchase of Series C preferred stock, we also entered into the Agreement and Plan of Merger under which we had an option to acquire by merger the remaining outstanding shares of Corus. In July 2006, we announced that we had agreed to exercise this option and concurrently we entered into an agreement with Novartis Vaccines and Diagnostics, Inc. (Novartis) whereby Novartis agreed to dismiss its litigation against Corus for a payment to be made by Gilead to Novartis. Since the claims made by Novartis directly implicated Corus’s right to develop and commercialize its products, settling with Novartis was deemed appropriate to allow completion of the acquisition and to ensure claims by Novartis could not impede our ability to further develop and commercialize Corus product candidates. Without a settlement, the results of the ongoing trial at the time of settlement would have been uncertain for a sustained period following the closing due to legal appeals and other potential proceedings. Upon completion of the acquisition, we included our investment in Corus’s Series C preferred stock and the payment to Novartis as part of the acquisition purchase price.

The aggregate purchase price for all of the acquired shares and assets was approximately $414.7 million, including cash paid at or prior to closing of $363.6 million, the fair value of vested stock options assumed of $7.4 million, estimated direct transaction costs of $3.2 million and employee-related severance costs of $4.0 million. In addition, a holdback amount of $36.5 million is payable to Corus shareholders by Gilead in the future, except to the extent utilized to pay claims made by Gilead within one year after the closing of the merger. We assessed that it is probable that we will pay out this holdback amount, therefore we recorded this amount in other accrued liabilities on our condensed consolidated balance sheet as of September 30, 2006.

 

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Employee related severance costs are included as part of the purchase price, as we established a workforce reduction plan as part of the acquisition transaction. These costs include employee termination benefits to be paid out within one year, as well as the stock-based compensation costs resulting from the accelerated vesting of stock options for employees who are involuntarily terminated in conjunction with a change in control as covered by Corus’s stock option plan.

The following table summarizes the preliminary purchase price allocation at August 11, 2006 (in thousands):

 

Net assets

   $ 4,191

Assembled workforce

     1,597

Net deferred tax assets

     53,376

In-process research and development

     355,568
      
   $     414,732
      

The $4.2 million of net assets includes $10.7 million of cash and short-term investments and $4.0 million of tangible assets, less assumed liabilities of $10.5 million. The $1.6 million value assigned to the assembled workforce is being amortized over three years, which is the estimated useful life of the asset. The $53.4 million of net deferred tax assets is primarily related to federal net operating loss and tax credit carryforwards. We have concluded that, based on the standard set forth in SFAS No. 109, it is more likely than not that we will realize the benefits from these deferred tax assets. We did not record any income tax benefit related to the purchased in-process research and development (IPR&D) charge as such amount is non-deductible. This purchase price allocation is preliminary and has not been finalized in that we are currently reviewing the allocation. Material changes, if any, to the preliminary allocation summarized above, will be reported once the uncertainty has been resolved.

The estimated fair value of purchased IPR&D and assembled workforce was determined by our management based in part on an independent appraisal. The estimated fair value of purchased IPR&D is greater than the purchase price paid, therefore, the amount that was allocated to purchased IPR&D consists of the net amount remaining after allocating the purchase price to the net tangible assets, assembled workforce and net deferred tax assets. The purchased IPR&D represented Corus’s incomplete R&D program that had not yet reached technological feasibility and had no alternative future use as of the acquisition date. A summary of this program at the acquisition date is as follows:

 

Program

  

Description

  

Status of Development

  

Estimated
Acquisition
Date Fair
Value

(in millions)

Aztreonam lysine for cystic fibrosis    Aztreonam formulation for inhalation to be used against Gram-negative bacteria that cause lung infections in patients with cystic fibrosis.    Phase 3 clinical trials at acquisition date. We expect to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in late 2007.    $ 355.6

The remaining efforts for completion of Corus’s R&D project primarily consist of clinical trials, the cost, length and success of which are extremely difficult to predict. Numerous risks and uncertainties exist that could prevent completion of development, including the ability to enroll patients in clinical trials, the possibility of unfavorable results of our clinical trials, and the risk of failing to obtain FDA and other regulatory body approvals. Feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. We cannot be certain that aztreonam lysine for cystic fibrosis, purchased from Corus, will be approved in the United States or the European Union or whether marketing approvals will have significant limitations on its use. Future discussions with regulatory agencies will determine the amount of data needed and timelines for review, which may differ materially from current projections. The acquired product candidate under development may never be successfully commercialized. As a result, we may make a strategic decision to discontinue development of this product candidate, if we believe commercialization will be difficult relative to other opportunities in our pipeline. If this program cannot be completed on a timely basis or at all, then our prospects for future revenue growth would be adversely impacted.

The value of the purchased IPR&D was determined by estimating the related future net cash flows using a present value risk adjusted discount rate of 16%. This discount rate is a significant assumption and is based on the estimated internal rate of return for Corus’s operations and is comparable to the estimated weighted average cost of capital for companies in Corus’s industry. The projected cash flows from the aztreonam program were based on estimates of revenues and operating profits related to the program considering its stage of development, the time and resources needed to complete the development and approval of the related product, the life of the potential commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a drug compound such as obtaining FDA and other regulatory approvals, and risks related to the viability of and potential alternative treatments in any future target markets. Corus’s two other early-stage candidates were not included in the valuation of purchased IPR&D because they were early-stage projects that did not have identifiable revenues and expenses associated with them.

 

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Raylo Chemicals Inc.

On November 3, 2006, we completed the acquisition of Raylo Chemicals Inc., a subsidiary of Germany-based specialty chemicals company Degussa AG, for approximately €107.1 million (approximately $136 million). Raylo’s operations encompass custom manufacturing of API and advanced intermediates for the pharmaceutical and biopharmaceutical industries. The Company entered into a Euro forward contract in June 2006 in order to hedge the U.S. dollar price of the transaction. The Euro forward contract matured on November 3, 2006. The forward contract does not qualify for hedge accounting treatment under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133) and therefore all changes in fair value are recorded in interest and other income, net, in our Condensed Consolidated Statements of Operations. Gilead paid a deposit of €18.0 million ($23.0 million) upon execution of the stock purchase agreement in June 2006 which we recorded in other current assets in our Condensed Consolidated Balance Sheets.

Additionally, Gilead Sciences Limited (GSL), one of our wholly-owned Irish subsidiaries, entered into a seven-year supply agreement with Degussa for the manufacture and supply of certain API for certain of Gilead’s products. During the term of the agreement, Gilead is obligated to purchase total API valued at approximately €177.0 million (approximately $221.8 million). Gilead has guaranteed the performance of GSL under this agreement.

IOCB and K.U. Leuven

On August 18, 2006, we executed a sixth amendment agreement with the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic and K. U. Leuven Research and Development. This amendment sets forth our royalty obligations for the sale of tenofovir in upper and lower middle income and Gilead Access Program countries. In upper and lower middle income countries, we will pay a royalty equal to three percent of the gross amount that we receive from any third party in consideration for the sale of tenofovir. For sales of tenofovir in the Gilead Access Program countries, pursuant to licenses we granted to 11 companies in India, we will pay a royalty equal to 20 percent of the gross amount received from any such Indian company in consideration for the sale of tenofovir.

8. JOINT VENTURE WITH BRISTOL-MYERS SQUIBB

In December 2004, we entered into a collaboration with BMS to develop and commercialize the single tablet regimen of Gilead’s Truvada ® ( emtricitabine and tenofovir disoproxil fumarate) and BMS’s Sustiva in the United States. Structured as a joint venture, Gilead and BMS formed the limited liability company, Bristol-Myers Squibb & Gilead Sciences, LLC. Under the terms of the collaboration, Gilead and BMS granted royalty-free sublicenses to the joint venture for the use of their respective company-owned technologies and, in return, were granted a license by the joint venture to use any intellectual property that results from the collaboration. The ownership interests of the joint venture by Gilead and BMS, which reflect their respective economic interests, are based on the fraction of the estimated net selling price of the single tablet regimen attributable to Truvada and Sustiva, respectively, and will be adjusted on an annual basis. Since the net selling price for Truvada may change over time relative to the net selling price of Sustiva, both Gilead’s and BMS’s respective economic interests in the joint venture may vary annually.

Gilead has primary responsibility for clinical development activities and regulatory filings relating to any new products resulting from the collaboration, and BMS and Gilead share marketing and sales efforts (both parties provide equivalent sales force efforts for a minimum number of years). The daily operations of the joint venture are governed by four primary joint committees. Gilead is responsible for accounting, financial reporting and product distribution for the joint venture. Both parties agreed to provide their respective bulk active pharmaceutical ingredient (API) to the joint venture at their approximate market values. In April 2006, the joint venture filed a NDA with the FDA for approval of the single tablet regimen for the treatment of HIV infection in adults and in July 2006, the joint venture received approval for this single tablet regimen, which has been given the trade name Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate). On September 28, 2006, Gilead and BMS amended the joint venture’s collaboration agreement to allow the joint venture to sell Atripla into Canada. As of September 30, 2006, the joint venture held Sustiva API which it purchased from BMS at BMS’s estimated net selling price of Sustiva in the U.S. market and included in inventory on our condensed consolidated balance sheet (see Note 2).

The joint venture’s total equity investment at risk is not expected to be sufficient to allow it to finance its operational activities without the ongoing funding of Gilead and BMS. Although we are the primary beneficiary, the legal structure of the joint venture limits the recourse that its creditors will have over the general credit or assets of Gilead. As explained in Note 1, our Condensed Consolidated Financial Statements include the accounts of our joint venture with BMS and reflect BMS’s minority interest in the joint venture.

 

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9. LONG-TERM OBLIGATIONS

Convertible Senior Notes

In April 2006, we issued $650.0 million principal amount of convertible senior notes due 2011 (2011 Notes) and $650.0 million principal amount of convertible senior notes due 2013 (2013 Notes) (collectively, the Notes) in a private placement pursuant to Rule 144A of the Securities Act of 1933, as amended. The 2011 Notes and the 2013 Notes were issued at par and bear interest rates of 0.50% and 0.625%, respectively. Debt issuance costs of $23.8 million in connection with the issuance of the Notes were recorded in other noncurrent assets and are being amortized to interest expense on a straight-line basis over the contractual terms of the Notes. The aggregate principal amount of the Notes sold reflects the full exercise by the initial purchasers of their option to purchase additional Notes to cover over-allotments. The 2011 Notes may be convertible based on an initial conversion rate of 12.9024 shares per $1,000 principal amount of 2011 Notes (which represents an initial conversion price of approximately $77.50 per share). The 2013 Notes may be convertible based on an initial conversion rate of 13.1230 shares per $1,000 principal amount of 2013 Notes (which represents an initial conversion price of approximately $76.20 per share). The Notes may be converted, subject to adjustment, only under the following circumstances: 1) during any calendar quarter beginning after September 30, 2006 if the closing price of our common stock for at least 20 trading days during the last 30 consecutive trading day period of the previous quarter is more than 130% of the applicable conversion price per share, 2) if we make specified distributions to holders of our common stock or if specified corporate transactions occur, or 3) during the last month prior to maturity of the applicable Notes. Upon conversion, a holder would receive an amount in cash equal to the lesser of (i) the principal amount of the Note or (ii) the conversion value for such Notes. If the conversion value exceeds $1,000, we may also deliver, at our option, cash or common stock or a combination of cash and common stock for the conversion value in excess of $1,000. If the Notes are converted in connection with a change in control, we may be required to provide a make-whole premium in the form of an increase in the conversion rate, subject to a stated maximum amount. In addition, in the event of a change in control, the holders may require us to purchase all or a portion of their Notes at a purchase price equal to 100% of the principal amount of the Notes, plus accrued and unpaid interest thereon, if any.

Concurrent with the issuance of the Notes, we purchased convertible note hedges in private transactions at a cost of $379.1 million to cover, subject to customary anti-dilution adjustments, 16.9 million shares of our common stock at strike prices that correspond to the initial conversion prices of the Notes. If the market value per share of our common stock at the time of conversion of the Notes is above the strike price of the applicable convertible note hedges, we are entitled to receive from the counterparties in the transactions cash or common stock or a combination of cash and common stock for the excess of the then market price of the common stock over the strike price of the convertible note hedges. We also sold warrants to acquire 16.9 million shares of our common stock, subject to customary anti-dilution adjustments, in private transactions and received net proceeds of $235.5 million. If the market value of our common stock at the time of the exercise of the applicable warrants exceeds their respective strike prices, we will be required to net settle with the respective counterparties for the value of the warrants in excess of the warrant strike prices. The warrants have strike prices of $101.60 per share (for the warrants expiring in 2011) and $107.79 per share (for the warrants expiring in 2013) and are exercisable only on the respective expiration dates. Taken together, the convertible note hedges and warrants are intended to reduce the potential dilution upon future conversions of the Notes by effectively increasing the initial conversion price to $101.60 per share for the 2011 Notes and $107.79 per share for the 2013 Notes. The net cost of $143.7 million of the convertible note hedges and warrant transactions was recorded in stockholders’ equity.

In accordance with EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock and SFAS 133, we recorded the convertible note hedges and warrants in additional paid-in capital (APIC) as of June 30, 2006, and we will not recognize subsequent changes in their respective fair values. In addition, in accordance with SFAS 109 and EITF No. 05-08, Income Tax Consequences of Issuing Convertible Debt with a Beneficial Conversion Feature , we also recorded a deferred tax asset of $147.9 million in APIC for the effect of the future tax benefits related to the convertible note hedges.

Contemporaneously with the closing of the sale of the Notes, a portion of the net proceeds from the Notes’ issuance and the proceeds of the warrant transactions was used to repurchase 8.4 million shares of our common stock for $544.9 million under our stock repurchase program.

Credit Facilities

In December 2005, we entered into an agreement with a syndicate of banks for a five-year $500.0 million senior credit facility. The $500.0 million facility consisted of an uncollateralized $300.0 million term loan, which was entered into by Gilead Biopharmaceutics Ireland Corporation (GBIC), one of our wholly-owned Irish subsidiaries, and an uncollateralized $200.0 million revolving credit facility, which was entered into by the U.S. parent company, Gilead Sciences, Inc. The proceeds from the term loan were used by GBIC in December 2005 to facilitate a cash dividend distribution of $280.0 million to the parent company as part of the repatriation of our qualified foreign earnings under the provisions of the American Jobs Creation Act.

Under the terms of our term loan, the minimum amount of the principal payment that is required to be repaid at the end of each calendar quarter, beginning on March 31, 2006, is five percent of the outstanding balance. Interest is accrued at a rate of LIBOR plus a tiered contractual rate of up to 62.5 basis points and is payable quarterly in arrears. GBIC can prepay the term loan, together with accrued interest on the prepaid principal, at any time in whole or in part without penalty or premium. During the nine months ended

 

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September 30, 2006, $161.0 million of the term loan principal was repaid. Any outstanding interest or principal at December 2010 is payable on demand. The U.S. parent company and another wholly-owned subsidiary, Gilead Vintage Park, LLC, are guarantors. As of September 30, 2006, the outstanding principal on the term loan was $139.0 million.

Under the terms of the revolving credit facility, interest is accrued and payable at a rate of LIBOR plus a tiered contractual rate of up to 50 basis points, and is payable quarterly in arrears. The parent company can prepay any outstanding borrowings, together with accrued interest on the prepaid principal, at any time in whole or in part without penalty or premium. Any outstanding interest or principal at December 2010 is payable on demand. The capacity of the revolving credit facility will increase to a maximum of $500.0 million as the term loan is repaid. We have the ability to irrevocably cancel any unutilized portion of the revolving credit facility, in whole or in part. Any proceeds obtained under the revolving credit facility are expected to be used for working capital, capital expenditures and other general corporate purposes, including the issuance of letters of credit up to $25.0 million. Gilead Vintage Park, LLC is the guarantor. In September 2006, the revolving credit facility was increased to $361.0 million as a result of cumulative principal repayments of $161.0 million that we have made under the term loan. As of September 30, 2006, we did not have any borrowings under the revolving credit facility.

10. CONTINGENCIES

Legal Proceedings

A number of states, counties and municipalities have filed complaints alleging that a large number of pharmaceutical company defendants, including Gilead in some instances, reported inaccurate prices for their products, causing the governmental entity named as the plaintiff to overpay for pharmaceutical products furnished to participants in the Medicaid program. Separate actions filed by New York City and numerous New York counties were consolidated into a multi-district litigation proceeding before the United States District Court for the District of Massachusetts. On August 23, 2005, these cases were voluntarily dismissed with respect to Gilead. On August 3 and October 12, 2006, two similar actions, State of Alabama v. Abbott Laboratories, Inc. et al., currently pending in the Circuit Court of Montgomery County, Alabama, and State of Mississippi v. Abbott Laboratories, Inc., et al., currently pending in the Chancery Court of the First Judicial District of Hinds County, Mississippi were voluntarily dismissed with respect to Gilead. To our knowledge, we have been named in three additional cases, (1) County of Erie v. Abbott Laboratories, Inc. et al., currently pending in the Supreme Court of the State of New York, in the County of Erie; (2) County of Oswego v. Abbott Laboratories, Inc. et al., currently pending in the Supreme Court of the State of New York, in the County of Oswego; and (3) County of Schenectady v. Abbott Laboratories, Inc. et al., currently pending in the Supreme Court of the State of New York, in the County of Schenectady. The complaints assert claims under state law and seek damages (and, in some cases, treble damages) and attorneys’ fees. We intend to defend the cases vigorously. The cases are all at a preliminary stage and it is not possible to predict the outcome. As such, no amounts have been accrued related to the outcome of these cases.

On May 12, 2006, the United States District Court for the Northern District of California executed orders dismissing in its entirety and with prejudice the Fourth Consolidated Amended Complaint associated with a purported class action lawsuit against Gilead and our Chief Executive Officer, Chief Financial Officer, former Executive Vice President of Operations (and current Senior Business Advisor), Executive Vice President of Research and Development, Senior Vice President of Manufacturing and Senior Vice President of Research, alleging that the defendants violated federal securities laws, specifically Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated by the Securities and Exchange Commission, by making certain alleged false and misleading statements. The plaintiffs have appealed the dismissal.

We are also a party to various other legal actions that arose in the ordinary course of our business. We do not believe that any of these other legal actions will have a material adverse impact on our business, results of operations or financial position.

Other Matters

In March 2006, we initiated an evaluation of our European distribution framework outside of our existing European subsidiaries. As a result, we initiated contact with certain of our European distributors with our intent to ultimately terminate these distribution agreements. This process may entail lengthy negotiations with these distributors. Although it is probable that we will incur contract termination costs, we are currently unable to reasonably estimate such costs in accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities and as such, no amount has been accrued related to the outcome of these negotiations.

11. STOCK-BASED COMPENSATION

On January 1, 2006, we adopted the provisions of SFAS 123R which requires that the fair value of all share-based payments to employees and directors, including grants of stock options, be recognized in our Condensed Consolidated Statements of Operations. We applied the modified prospective method, one of the adoption methods permitted under SFAS 123R, which requires that compensation expense be recorded for the vesting of all nonvested stock options and other stock-based awards at the beginning of the first quarter of adoption of SFAS 123R. In accordance with the modified prospective method, no prior period amounts have been restated to reflect our adoption of SFAS 123R.

 

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Pro Forma Information Under SFAS 123

Prior to the adoption of SFAS 123R, in accordance with the provisions of SFAS 123, as amended by SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure , we elected to follow APB 25, and FASB Interpretation No. 44, Accounting for Certain Transactions Involving Stock Compensation—an Interpretation of APB Opinion No. 25 , in accounting for our employee stock-based plans. Under APB 25, if the exercise price of Gilead’s employee and director stock options was equal to or greater than the fair value of the underlying stock on the date of grant, no compensation expense was recognized in our Condensed Consolidated Statements of Operations.

The table below presents net income and basic and diluted net income per share as if compensation cost for the Company’s stock option plans and employee stock purchase plan (ESPP) had been determined based on the estimated fair value of awards under those plans on the grant or purchase date in accordance with SFAS 123 (in thousands, except per share amounts):

 

    

Three Months Ended

September 30, 2005

    Nine Months Ended
September 30, 2005
 

Net income – as reported

   $ 179,232     $ 532,312  

Add: Stock-based employee compensation expense included in reported net income, net of related tax effects

     25       172  

Deduct: Total stock-based employee compensation expense determined under the fair value based method for all awards, net of related tax effects

     (19,752 )     (60,258 )
                

Pro forma net income

   $     159,505     $     472,226  
                

Net income per share:

    

Basic - as reported

   $ 0.39     $ 1.18  
                

Basic - pro forma

   $ 0.35     $ 1.04  
                

Diluted - as reported

   $ 0.38     $ 1.13  
                

Diluted - pro forma

   $ 0.34     $ 1.00  
                

Adoption of SFAS 123R

Stock-based compensation is recognized as expense over the requisite service periods in our Condensed Consolidated Statements of Operations using a graded vesting expense attribution approach for nonvested stock options granted prior to the adoption of SFAS 123R and using the straight-line expense attribution approach for stock options granted after the adoption of SFAS 123R. As stock-based compensation expense related to stock options recognized on adoption of SFAS 123R is based on awards ultimately expected to vest, gross expense has been reduced for estimated forfeitures. SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. We estimated forfeitures based on our historical experience. Prior to the adoption of SFAS 123R, pro forma information required under SFAS 123 included forfeitures as they occurred.

The table below summarizes the impact of adopting SFAS 123R effective January 1, 2006 (in thousands, except per share amounts):

 

    

Three Months Ended

September 30, 2006

    Nine Months Ended
September 30, 2006
 

Cost of goods sold

   $ 2,524     $ 8,236  

Research and development expenses

     13,267       38,108  

Selling, general and administrative expenses

     15,954       51,800  
                

Stock-based compensation expense included in total costs and expenses

     31,745       98,144  

Tax benefit related to stock-based compensation expense

     (6,165 )     (21,340 )
                

Stock-based compensation expense included in net income

   $ 25,580     $ 76,804  
                

Stock-based compensation expense included in net income (loss) per share:

    

Basic

   $ 0.06     $ 0.17  
                

Diluted

   $ 0.06     $ 0.16  
                

During the three and nine months ended September 30, 2006, we capitalized $2.6 million and $7.7 million of stock-based compensation expense, respectively, into inventory. The total fair value of stock options that vested during the three and nine months ended September 30, 2006 was $29.3 million and $96.4 million, respectively. As of September 30, 2006, we had stock-based compensation expense of $236.4 million related to nonvested stock options not yet recognized, which is expected to be recognized over an estimated weighted average period of 2.1 years.

 

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Valuation Assumptions

Fair values of awards granted under the stock option plans and ESPP were estimated at grant or purchase dates using a Black-Scholes option valuation model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including expected stock price volatility and expected award life. In connection with our adoption of SFAS 123R, we refined the methodologies used to derive our valuation model assumptions. To calculate the estimated fair value of the awards, we used the following assumptions:

 

     Three Months Ended
September 30,
  

Nine Months Ended

September 30,

     2006    2005    2006    2005

Expected volatility:

           

Stock options

   38%    45%    39%    45%

ESPP

   34%    45%    34%    45%

Expected life in years:

           

Stock options

   5.1    4.7    5.2    4.8

ESPP

   1.3    1.3    1.3    1.3

Risk-free interest rate:

           

Stock options

   4.8%    4.0%    4.7%    3.8%

ESPP

   5.0%    3.8%    4.9%    3.3%

Expected dividend yield

   0%    0%    0%    0%

The fair value of stock options granted prior to the adoption of SFAS 123R was calculated using the multiple option approach while the fair value of stock options granted beginning January 1, 2006 was calculated using the single option approach.

Prior to the adoption of SFAS 123R, we used historical stock price volatility. In connection with our adoption of SFAS 123R, we determined that a blend of historical volatility along with implied volatility for traded options on Gilead’s stock is a better reflection of market activity and expected volatility.

The expected life of stock-based awards represents the weighted-average period the awards are expected to remain outstanding. We estimate the weighted-average expected life based on historical cancellation and historical exercise data related to our stock options as well as the contractual term and vesting terms of the awards.

The risk-free interest rate is based upon observed interest rates appropriate for the term of the stock-based awards. The dividend yield is based on our history and expectation of dividend payouts.

Other Stock-Based Compensation Information

In May 2004, Gilead’s stockholders approved and we adopted our 2004 Equity Incentive Plan (2004 Plan). Stock options under the NeXstar Pharmaceuticals, Inc. (NeXstar), Triangle Pharmaceuticals, Inc. (Triangle) and Corus stock option plans, which we assumed as a result of the merger with NeXstar and the acquisitions of Triangle and Corus, have been converted into Gilead options effective with the merger or acquisition. The 2004 Plan is a broad-based, incentive plan that allows for the awards to be granted to employees, directors and consultants of Gilead. Historically, few grants have been made to consultants and currently there are no grants outstanding to consultants. The 2004 Plan provides for option grants designated as either nonqualified or incentive stock options. Gilead assumed Corus’s 2001 Stock Plan (Corus Plan) in conjunction with the acquisition of the net assets of Corus. Options pursuant to the Corus Plan that were issued and outstanding as of August 11, 2006 have been converted into options to purchase approximately 333,551 shares of Gilead common stock as a result of the acquisition and remain subject to their original terms and conditions. No shares are available for grant of future options under the Corus Plan.

In May 2006, Gilead’s stockholders approved an increase of an additional 10,000,000 in the number of shares of common stock, available for issuance under the 2004 Plan. Prior to January 1, 2006, Gilead granted both nonqualified and incentive stock options, but all stock options granted after January 1, 2006 have been nonqualified stock options. Under the 2004 Plan, employee stock options generally vest over five years, are exercisable over a period not to exceed the contractual term of ten years from the date the stock options are issued and are granted at prices not less than the fair value of our common stock on the grant date. Stock option exercises are settled with newly issued common stock from the 2004 Plan’s previously authorized and available pool of shares. As of September 30, 2006, there were 23,164,332 shares remaining and available for future grant under the 2004 Plan.

Under Gilead’s ESPP, employees can purchase shares of Gilead common stock based on a percentage of their compensation subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair value of our common stock on the offering date or the purchase date. A two-year look-back feature in our ESPP causes the offering period to reset if the fair value of our common stock on the purchase date is less than that on the original offering date. ESPP purchases by employees are settled with newly issued common stock from the ESPP’s previously authorized and available pool of shares. As of September 30, 2006, there were 1,444,861 shares remaining and available for issuance under the ESPP.

 

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The following table summarizes activity under all Gilead, NeXstar, Triangle and Corus stock option plans. All option grants presented in the table had exercise prices not less than the fair value of the underlying common stock on the grant date (shares in thousands):

 

     Nine Months Ended
September 30, 2006
  

Year Ended

December 31, 2005

     Shares     Weighted
Average
Exercise
Price
   Shares    

Weighted

Average

Exercise

Price

Outstanding, beginning of period

   45,920     $     22.60    49,413     $     18.10

Granted and assumed

   8,527     $ 57.16    8,930     $ 36.39

Forfeited

   (1,624 )   $ 32.27    (1,997 )   $ 26.05

Exercised

   (7,116 )   $ 16.08    (10,426 )   $ 12.45
                 

Outstanding, end of period

   45,707     $ 29.71    45,920     $ 22.60
                 

Exercisable, end of period

   22,356     $ 18.93    22,237     $ 15.56
                 

Weighted average grant-date fair value

     $ 27.16      $ 15.79

The following is a summary of Gilead stock options outstanding and stock options exercisable at September 30, 2006 (options and aggregate intrinsic value in thousands):

 

     Options Outstanding    Options Exercisable

Range of Exercise Prices

   Options
Outstanding
   Weighted
Average
Remaining
Contractual Life
in Years
   Weighted
Average
Exercise
Price
  

Aggregate

Intrinsic Value

   Options
Exercisable
   Weighted
Average
Remaining
Contractual Life
in Years
   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic Value

$2.85 - $16.44

   9,909    3.9    $ 9.45    $ 587,810    9,534    3.8    $ 9.21    $ 567,866

$16.45 - $28.24

   9,192    6.2    $ 18.85      458,875    5,996    6.1    $ 18.32      302,493

$28.36 - $31.34

   11,009    7.6    $ 30.18      424,893    4,259    7.5    $ 30.07      164,793

$31.40 - $57.36

   9,461    8.5    $ 41.88      254,451    2,550    7.9    $ 37.76      79,081

$57.91 - $70.47

   6,136    9.4    $ 59.14      59,104    17    1.1    $ 68.01      34
                                   

Total

   45,707    6.9    $     29.71    $     1,785,133    22,356    5.6    $     18.93    $     1,114,267
                                   

The total intrinsic value of options exercised during the nine months ended September 30, 2006 was $312.5 million.

Restricted Stock

The following is a summary of the activity relating to Gilead’s nonvested restricted stock awards for the nine months ended September 30, 2006:

 

     Shares    

Weighted

Average

Grant-Date
Fair Value

Nonvested, January 1, 2006

   —       $ —  

Granted

   32,250     $     61.94

Forfeited

   —       $ —  

Vested

   (1,000 )   $ 58.91
        

Nonvested, September 30, 2006

   31,250     $ 62.03
        

12. STOCKHOLDERS’ EQUITY

Stock Repurchase Program

In March 2006, Gilead’s Board of Directors authorized a program for the repurchase of Gilead common stock in an amount of up to $1.0 billion over a two year period. Stock repurchases under this program may be made through open market and private block

 

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transactions pursuant to Rule 10b5-1 plans or privately negotiated purchases or other means, including accelerated stock repurchase transactions or similar arrangements. The timing and actual number of shares repurchased will depend on a variety of factors including price, corporate and regulatory requirements and other market conditions.

In April 2006, Gilead repurchased and retired 8.4 million shares of Gilead common stock at $65.13 per share for an aggregate of $544.9 million and retired the shares. The remaining authorized amount of stock repurchases that may be made under this stock repurchase program which terminates in March 2008 is $455.0 million. We use the par value method of accounting for our stock repurchases. Under the par value method, common stock is first charged with the par value of the shares involved. The excess of the cost of shares acquired over the par value is allocated to APIC with the amounts in excess of the estimated original sales price charged to retained earnings. As a result of our stock repurchase in April 2006, we reduced common stock and APIC by $33.9 million and retained earnings by $511.0 million.

Comprehensive Income

The components of comprehensive income are as follows (in thousands):

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2006     2005     2006     2005  

Net income (loss)

   $     (52,164 )   $     179,232     $     475,690     $     532,312  

Net foreign currency translation gain (loss)

     1,234       (1,221 )     1,658       (6,249 )

Net unrealized gain (loss) on cash flow hedges, net of related tax effects

     (53 )     (941 )     (14,704 )     35,506  

Net unrealized gain (loss) on available-for-sale securities, net of related tax effects

     20,250       (874 )     7,530       (1,167 )
                                

Comprehensive income (loss)

   $ (30,733 )   $ 176,196     $ 470,174     $ 560,402  
                                

13. SEGMENT INFORMATION

Gilead operates in one business segment, which primarily focuses on the development and commercialization of human therapeutics for infectious diseases. All products are included in one segment because our major products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment.

Product sales consisted of the following (in thousands):

 

    

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

     2006    2005    2006    2005

HIV products:

           

Truvada

   $ 309,033    $ 162,403    $ 857,235    $ 376,680

Viread ® (tenofovir disoproxil fumarate)

     170,624      189,395      529,841      596,349

Atripla

     68,373      —        68,373      —  

Emtriva ® (emtricitabine)

     9,272      11,737      27,899      36,314
                           

Total HIV product sales

     557,302      363,535      1,483,348      1,009,343

AmBisome

     55,313      54,736      164,740      165,157

Hepsera

     55,113      46,893      164,612      135,364

Vistide ® (cidofovir injection)

     2,114      1,808      6,264      4,906

DaunoXome ® (liposomal daunorubicin injection)

     218      232      1,140      1,103
                           

Total product sales

   $     670,060    $     467,204    $     1,820,104    $     1,315,873
                           

 

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Product sales and product-related contract revenues are attributed to countries based on ship-to location. Royalty and non-product related contract revenues are attributed to countries based on the location of the collaboration partner. Certain revenue amounts for 2005 have been reclassified between geographic regions to conform to the current period presentation. The following table summarizes total revenues from external customers and collaboration partners by geographic region (in thousands):

 

    

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

     2006    2005    2006    2005

United States

   $ 385,327    $ 256,294    $ 1,017,314    $ 722,311

Outside of the United States:

           

Switzerland

     68,307      15,382      264,396      69,385

France

     56,561      38,488      158,845      117,520

Spain

     41,467      29,625      118,836      91,239

United Kingdom

     40,687      30,719      112,205      84,537

Italy

     36,889      25,268      110,778      79,261

Germany

     29,803      24,090      90,841      75,007

Other European countries

     43,682      38,769      134,798      96,490

Other countries

     46,010      34,816      118,900      83,384
                           

Total revenues outside of the United States

     363,406      237,157      1,109,599      696,823

Total revenues

   $     748,733    $     493,451    $     2,126,913    $     1,419,134
                           

The following table summarizes revenues from our customers and collaboration partner who individually account for 10% or more of our total revenues (as a % of total revenues):

 

    

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

     2006    2005    2006    2005

Cardinal Health, Inc.

   18%    20%    17%    19%

McKesson Corp.

   13%    12%    12%    12%

F. Hoffmann-La Roche Ltd.

   *    *    12%    *

AmerisourceBergen Corp.

   11%    12%    11%    12%

* Amount less than 10%

14. SUBSEQUENT EVENT

In October 2006, we signed a definitive agreement with Myogen, Inc., under which we plan to acquire Myogen in a cash transaction for approximately $2.5 billion. Myogen is a publicly held biopharmaceutical company based in Westminster, Colorado, focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. We expect the acquisition to close in the fourth quarter of 2006, subject to the satisfaction of certain closing conditions.

In anticipation of the cash outlay to consummate the Myogen acquisition, we reclassified certain of our marketable securities from long-term to short-term assets based on our intent to liquidate and access the underlying cash. Additionally, since it is probable that the full value of certain of our marketable securities will not be realized at the time of their liquidation, we recognized during the three months ended September 30, 2006, a loss of approximately $6.6 million associated with the planned sale of such securities.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

In evaluating our business, you should carefully consider the risks described in the section titled “Risk Factors” below, in addition to the other information in this Quarterly Report on Form 10-Q. Any of the following risks could materially and adversely affect our business, results of operations and financial condition. In particular, this Form 10-Q contains forward-looking statements based on our current expectations. Words such as “expect,” “anticipate,” “target,” “goal,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “continue,” “may,” variations of such words, and similar expressions are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, our anticipated trends in our businesses, and other characterizations of future events or circumstances are forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are made only as of the date hereof. Except as required under federal securities laws and the rules and regulations of the SEC, we do not undertake any obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. It is not possible to predict or identify all such factors and, therefore, you should not consider any of the above risks to be a complete statement of all the potential risks or uncertainties that we face.

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2005 and our unaudited condensed consolidated financial statements for the nine-month period ended September 30, 2006 and other disclosures (including the disclosures under “Item 1A. Risk Factors”) included in this Quarterly Report on Form 10-Q. Our condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles and are presented in U.S. dollars.

Executive Summary

We are a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases. We are a multinational company, with revenues from ten approved products and marketing operations in twelve countries. We focus our research and clinical programs on anti-infectives. Currently, we market Truvada ® (emtricitabine and tenofovir disoproxil fumarate), Viread ® (tenofovir disoproxil fumarate), and Emtriva ® (emtricitabine) for the treatment of HIV infection; Hepsera ® (adefovir dipivoxil) for the treatment of chronic hepatitis B; AmBisome ® (amphotericin B) liposome for injection for the treatment of fungal infection; and Vistide ® (cidofovir injection) for the treatment of cytomegalovirus (CMV) retinitis and DaunoXome ® (liposomal daunorubicin injection) for the treatment of advanced HIV-related Kaposi’s sarcoma. In July 2006, we also began marketing Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate), a single tablet regimen of our Truvada and Bristol-Myers Squibb Company’s (BMS) Sustiva ® (efavirenz), with our joint venture partner, BMS. F. Hoffmann-La Roche Ltd (Roche) currently markets Tamiflu ® (oseltamivir phosphate) for the treatment and prevention of influenza under a royalty-paying development and license agreement with us. OSI Pharmaceuticals, Inc. (OSI) markets Macugen ® (pegaptanib sodium injection) in the United States and Europe for the treatment of neovascular age-related macular degeneration under a royalty-paying collaborative agreement with us.

Our operating results for the third quarter of 2006 were led by strong net product sales of $670.1 million including HIV product sales (Truvada, Viread, Atripla and Emtriva) of $557.3 million. A 53% increase in HIV product sales in the third quarter of 2006 over the third quarter of 2005 served as a key driver in increasing total product sales by 43% over the comparable period in 2005. HIV product sales were up 17% sequentially from the second quarter of 2006, mainly due to the continued growth of Truvada in Europe and the launch of Atripla in the United States in July 2006. This increase was offset by a decrease in sales of Viread in the third quarter of 2006 from the third quarter of 2005 due primarily to patients switching from a Viread-containing regimen to one containing Truvada and Atripla in countries where Truvada and Atripla are available. AmBisome product sales in the third quarter of 2006 increased by one percent compared to the third quarter of 2005. Hepsera product sales for the third quarter of 2006 increased 18% from the third quarter of 2005 driven primarily by sales volume growth in Europe. On the collaborative front, we recognized $76.2 million in royalty revenue of which $62.7 million related to royalties received from second quarter 2006 sales of Tamiflu by Roche. Tamiflu royalties increased from comparable periods in 2005 due to strong sales of Tamiflu by Roche as well as the elimination of the contractual cost of goods adjustment that was implemented in 2005. In addition, during the quarter ended September 30, 2006, we received a $5.0 million milestone payment from GlaxoSmithKline (GSK), associated with achieving four consecutive quarters of Hepsera gross sales exceeding $75.0 million in GSK territories. This amount has been recorded as deferred revenue to be amortized into contract revenue over the life of our manufacturing supply agreement with GSK.

On January 1, 2006, we adopted the provisions of Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based Payment (SFAS 123R) and began expensing the fair value of stock-based awards. As a result, stock-based compensation expense is a significant component of the increase in our operating expenses for the three and nine months ended September 30, 2006 as compared to the same period in the prior year. Further discussion is included in “Critical Accounting Policies and Estimates” below.

 

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We continued to make progress in our HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) clinical programs. In the first quarter of this year, we dosed the first patient in a Phase 2 clinical study of our novel integrase inhibitor for HIV, GS 9137, which we licensed from Japan Tobacco Inc. (Japan Tobacco). This event triggered a $5.0 million milestone payment to Japan Tobacco, which we recorded in research and development (R&D) expenses during the first quarter of 2006. We completed enrollment of patients in this Phase 2 study in the second quarter of 2006. In October of this year, based on a review of data from our independent Data Safety Monitoring Board, we terminated the arm of the study with the lowest dose of GS 9137 (20 mg), amended the protocol and recommended that all patients in that arm of the study be transitioned to the high dose arm (125 mg). The study will otherwise continue as planned, and data from the trial are expected in the first half of 2007. In addition, we have identified a second integrase inhibitor for HIV, GS 9224, and filed an investigational new drug application (IND) with the U. S Food and Drug Administration (FDA) in October 2006. We expect to begin the Phase 1 clinical study for GS 9224 during the fourth quarter of 2006. In the HBV area, we completed enrollment of patients into our two pivotal Phase 3 clinical studies of tenofovir disoproxil fumarate for chronic hepatitis B in the second quarter of 2006. In the HCV area, our collaboration partner, Achillion Pharmaceuticals, Inc., advised us that they expect to begin dosing HCV infected patients in a Phase 1/2 viral dynamics clinical study of GS 9132 in the fourth quarter of 2006. In August of 2006, we filed an IND with the FDA for GS 9190, a non-nucleoside HCV polymerase inhibitor, for the potential treatment of hepatitis C. We expect to begin the Phase 1 clinical study for GS 9190 during the fourth quarter of 2006, and anticipate having results from this study in early 2007.

To further support our increasing levels of clinical and product development activities, in November 2006, we completed the acquisition of Raylo Chemicals Inc. (Raylo), which was Degussa AG (Degussa)’s Canadian subsidiary, for approximately €107.1 million (approximately $136 million). We plan to leverage Raylo’s operations and expertise primarily for manufacturing development work, including scale up of investigational products, supplying active pharmaceutical ingredients (API) for clinical research programs and supporting new product launch supplies for Gilead’s therapeutics. In June 2006, in conjunction with the stock purchase agreement with Degussa and its wholly-owned subsidiary, LaPorte Nederland BV, we also entered into a seven-year supply agreement with Degussa where we are obligated to purchase total API for certain of our products valued at approximately €177.0 million (approximately $221.8 million) over the contractual term.

Our move into new therapeutic areas has been marked by two transactions in 2006. On August 11, 2006, we completed the acquisition of Corus Pharma, Inc. (Corus), a privately held development stage biopharmaceutical company based in Seattle, Washington, focused on the development and commercialization of novel drugs for respiratory and infectious diseases. We accounted for the Corus acquisition as an acquisition of assets and included the results of operations of Corus since August 11, 2006, which primarily consisted of research and development expenses and to a lesser extent, selling, general and administrative expenses, in our condensed consolidated financial statements for the third quarter of 2006. The aggregate purchase price was approximately $414.7 million, including cash paid of $363.6 million for all of Corus’s outstanding stock, a holdback amount of $36.5 million payable to Corus shareholders if there are no claims or disputes brought forth by Gilead one year after the closing of the merger, the fair value of vested stock options assumed of $7.4 million, estimated direct transaction costs of $3.2 million and employee related costs of $4.0 million. We also recorded a purchased in-process research and development (IPR&D) expense of $355.6 million during the quarter ended September 30, 2006.

In October 2006, we signed a definitive agreement with Myogen, Inc. (Myogen), under which we plan to acquire Myogen in a cash transaction of approximately $2.5 billion. Myogen is a publicly held biopharmaceutical company based in Westminster, Colorado, focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. We expect the acquisition to close in the fourth quarter of 2006, subject to the satisfaction of other closing conditions. We also expect that, upon consummation, we will record a material charge to earnings related to this acquisition associated with purchased IPR&D.

In September 2006, we established a three-way joint venture, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited, a limited company incorporated in Ireland. The joint venture will be the holder of the marketing authorization for Atripla. The joint venture filed for marketing authorization with the European Medicines Agency in October 2006, under the centralized licensing procedure. When the marketing authorization application is finalized and approved, the joint venture will hold one marketing authorization in all member states of the European Union. Discussions among the three companies regarding agreements for manufacturing, commercialization and distribution of Atripla in the European Union are ongoing.

On August 18, 2006, we executed a sixth amendment agreement with the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic and K. U. Leuven Research and Development. This amendment sets forth our royalty obligations for the sale of tenofovir in upper and lower middle income and Gilead Access Program countries. In upper and lower middle income countries, we will pay a royalty equal to three percent of the gross amount that we receive from any third party in consideration for the sale of tenofovir. For sales of tenofovir in the Gilead Access Program countries, pursuant to licenses we granted to eleven companies in India, we will pay a royalty equal to 20 percent of the gross amount received from any such Indian company in consideration for the sale of tenofovir.

 

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In April 2006, we issued $1.30 billion principal amount of convertible senior notes and concurrently, we repurchased $544.9 million of our common stock under our stock repurchase program, purchased convertible note hedges at a cost of $379.1 million as well as sold warrants for proceeds of $235.5 million. These transactions, along with $738.6 million of operating cash flows generated during the first nine months of 2006, partially offset by $356.2 million of net cash paid for the Corus acquisition and $161.0 million of payments made towards the principal on our term loan, contributed to the increase in our cash, cash equivalents and marketable securities of $893.4 million from December 31, 2005. Our existing cash, cash equivalents and marketable securities will allow us to further our corporate development initiatives, including licensing opportunities and potential acquisitions such as the $2.5 billion Myogen acquisition expected to close in the fourth quarter of 2006, as well as to meet our ongoing working capital and infrastructure needs.

Critical Accounting Policies, Estimates and Judgments

For a more complete discussion, see “Critical Accounting Policies, Estimates and Judgments” included in our Annual Report on Form 10-K for the year ended December 31, 2005.

Revenue Recognition

Product Sales

We recognize revenues from product sales when there is persuasive evidence an arrangement exists, delivery to the customer has occurred, the price is fixed or determinable and collectibility is reasonably assured. We record estimated reductions to revenues for government rebates such as Medicaid reimbursements, customer incentives such as cash discounts for prompt payment, distributor fees, and expected returns of expired products. These estimates are deducted from gross product sales at the time such revenues are recognized. Of these reductions from gross product sales, government rebates significantly impact our reported net product sales and are based upon certain estimates that require complex and significant management judgments.

Government Rebates

We estimate amounts payable by us to government-managed Medicaid programs as well as to certain other qualifying federal and state government programs for the reimbursement of portions of the retail price of prescriptions filled that are covered by these programs. Government rebates that are invoiced directly to us are recorded in other accrued liabilities in our condensed consolidated balance sheets. For qualified programs that can purchase our products through wholesalers at a lower contractual government price, the wholesalers charge back to us the difference between their acquisition cost and the lower price, which we record as allowances against accounts receivable. We estimate these sales allowances based on contractual terms, historical utilization rates, any new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates for these programs, and channel inventory data as obtained from our major U.S. wholesalers in accordance with our inventory management agreements. It may take up to two quarters for the majority of actual rebates that we process against our government rebate accruals, to be invoiced to us. Based on the most current information available, our actual annual government rebates have varied by less than 3% from our estimates recorded for the related years. During the three and nine months ended September 30, 2006, $34.5 million and $100.6 million, respectively, representing 4% and 5% of total gross product sales, respectively, were deducted from gross product sales for government rebates. Actual government rebates for the years ended December 31, 2005 and 2004 have varied by less than 3% from our estimates recorded in those periods. As of September 30, 2006, we had accrued government rebates of $62.0 million in other accrued liabilities and allowances of $9.0 million recorded against accounts receivable.

Contract Revenue

Contract revenue for research and development is recorded as performance occurs and the earnings process is completed based on the performance requirements of the contract. Nonrefundable contract fees for which no further performance obligations exist, and where there is no continuing involvement by Gilead, are recognized when the payments are received or when collection is reasonably assured.

Revenue from non-refundable up-front license fees and milestone payments where we continue to have involvement, such as through a development collaboration or an obligation to supply product, are recognized as performance occurs and our obligations are completed. In accordance with the specific terms of Gilead’s obligations under these types of arrangements, revenues are recognized as the obligation is fulfilled or ratably over the development or manufacturing period. Revenues associated with substantive at-risk milestones are recognized based upon the achievement of the milestones as defined in the respective agreements. Advance payments received in excess of amounts earned are classified as deferred revenue.

Prepaid Royalties

We capitalize royalties that we have prepaid at cost, specifically those related to the emtricitabine royalties we paid to Emory University (Emory) for the HIV indication, based on the present value of the future royalty obligation that we would expect to pay to Emory assuming certain expected levels of our product sales incorporating the emtricitabine technology. The present value of our future royalty obligation was derived using our weighted average cost of capital. We review quarterly the expected future sales levels of our products and any indicators that might require a write-down in the net recoverable value of our asset or a change in

 

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the estimated life of the prepaid royalty. Some potential indicators of impairment include the launch of a significant product by a competitor, significant deviations in recognized product sales compared to forecast and product safety issues and recalls.

We amortize our prepaid royalties based on an effective royalty rate that we derive from forecasted HIV product sales incorporating emtricitabine. Our product sales forecasts are prepared annually and determined using our best estimates of future activity considering such factors as historical and expected future patient usage or uptake of our products, the introduction of complimentary or combination therapies or products, and future product launch plans. If a previously unanticipated and significant change occurs to our sales forecasts, including the introduction of a competing product by us or one of our competitors into the same HIV market as emtricitabine, we would prospectively update the royalty rate used to amortize our prepaid royalties which may increase future royalty expense. As of September 30, 2006, we had a prepaid royalty asset relating to the emtricitabine royalties we paid to Emory of $324.0 million. Amortization expense relating to this prepaid royalty asset was $3.4 million and $12.2 million for the three and nine months ended September 30, 2006, respectively.

Stock-based Compensation

In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123R, a revision of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), which requires that all share-based payments to employees and directors, including grants of stock options be recognized in the income statement based on their fair values. SFAS 123R supersedes Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) and amends SFAS No. 95, Statement of Cash Flows . On January 1, 2006, we adopted SFAS 123R using the modified prospective method of adoption as permitted under SFAS 123R which requires that compensation expense be recorded for all nonvested stock options and other stock-based awards as of the beginning of the first quarter of adoption. In accordance with the modified prospective method, no prior period amounts have been restated to reflect the provisions of SFAS 123R.

Prior to the adoption of SFAS 123R, in accordance with the provisions of SFAS 123, we elected to follow APB 25, and FASB Interpretation No. 44, Accounting for Certain Transactions Involving Stock Compensation—an Interpretation of APB Opinion No. 25 , in accounting for our employee stock-based plans. Under APB 25, if the exercise price of Gilead’s employee and director stock options was equal to or greater than the fair value of the underlying stock on the date of grant, no compensation expense was recognized. However, as required by SFAS 123, the pro forma impact of expensing the fair value of our stock options and employee stock purchase plan was disclosed in the notes to our condensed consolidated financial statements.

In connection with our adoption of SFAS 123R, we refined our valuation assumptions and the methodologies used to derive those assumptions; however, we elected to continue using the Black-Scholes option valuation model. The fair value of stock options granted prior to the adoption of SFAS 123R was calculated using the multiple option approach while the fair value of stock options granted beginning January 1, 2006 was calculated using the single option approach. Concurrent with our adoption of SFAS 123R, we determined that a blend of historical volatility along with implied volatility for traded options on Gilead’s stock would be a better measure of market conditions and expected volatility. Previously, we used historical stock price volatility as it was the most reliable source of volatility data. We estimate the weighted-average expected life of our stock options based on historical cancellation and exercise data related to our stock options as well as the contractual term and vesting terms of the awards. We record stock-based compensation expense using a graded vesting expense attribution approach for nonvested stock options granted prior to the adoption of SFAS 123R consistent with the expense attribution approach used in our historical SFAS 123 disclosures and using a straight-line expense attribution approach for stock options granted after the adoption of SFAS 123R. We currently believe that the straight-line expense attribution approach better reflects the level of service to be provided over the vesting period of our awards. Stock-based compensation expense related to stock options is recognized net of estimated forfeitures. We estimated forfeitures based on our historical experience.

During the three and nine months ended September 30, 2006, we recognized stock-based compensation expense of $25.6 million and $76.8 million, respectively, net of tax, and we capitalized $2.6 million and $7.7 million, respectively, into inventory. As of September 30, 2006, we had unrecognized stock-based compensation of $236.4 million related to nonvested stock options, which is expected to be recognized over an estimated weighted average period of 2.1 years.

Results of Operations

Total Revenues

We had total revenues of $748.7 million for the quarter ended September 30, 2006 compared with $493.5 million for the quarter ended September 30, 2005. Total revenues were $2.13 billion for the first nine months of 2006 and $1.42 billion for the first nine months of 2005. Included in total revenues are product sales and royalty and contract revenue, including revenue earned from manufacturing collaborations.

 

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Product Sales

Product sales consisted of the following (in thousands):

 

   

Three Months Ended

September 30,

     

Nine Months Ended

September 30,

   
    2006   2005   Change   2006   2005   Change

HIV Products:

           

Truvada

  $ 309,033   $ 162,403   90%   $ 857,235   $ 376,680   128%

Viread

    170,624     189,395   (10)%     529,841     596,349   (11)%

Atripla

    68,373     —     100%     68,373     —     100%

Emtriva

    9,272     11,737   (21)%     27,899     36,314   (23)%
                           

Total HIV products

    557,302     363,535   53%     1,483,348     1,009,343   47%

AmBisome

    55,313     54,736   1%     164,740     165,157   0%

Hepsera

    55,113     46,893   18%     164,612     135,364   22%

Vistide

    2,114     1,808   17%     6,264     4,906   28%

DaunoXome

    218     232   (6)%     1,140     1,103   3%
                           

Total product sales

  $     670,060   $     467,204   43%   $     1,820,104   $     1,315,873   38%
                           

Total product sales increased 43% in the third quarter of 2006 compared to the third quarter of 2005, due primarily to higher sales of our HIV products and Hepsera.

HIV Products

HIV product sales for the third quarter of 2006 were $557.3 million, an increase of 53% compared to the third quarter of 2005. HIV product sales in the United States and outside of the United States for the third quarter of 2006 were $346.7 million and $210.6 million, respectively, an increase of 58% and 46%, respectively, compared to the same period in 2005. We continued to see steady prescription gains for our HIV product portfolio and as of the week ended September 30, 2006, according to a third-party market research firm, our HIV products collectively held approximately 46.7% and 44.7% of new and total prescriptions, respectively, in the nucleoside reverse transcriptase inhibitor market in the United States.

HIV product sales for the nine months ended September 30, 2006 totaled $1.48 billion, an increase of 47% from $1.0 billion for the nine months ended September 30, 2005. For the first nine months of 2006, HIV product volume increased by 28%, when compared to the same period last year, with volume increasing 15% in the United States and 45% outside of the United States, when compared to the same period last year. During the first nine months of 2006, Truvada continued to be launched in regions outside of the United States.

During the three and nine months ended September 30, 2006, the average selling prices of our HIV products increased compared to the same period in 2005 primarily driven by higher overall selling prices of our HIV products as well as the transition of some eligible patients in the Unites States from Medicaid to Medicare Part D, which reduced the amount of Medicaid claims. As a result of this transition, we benefited from a reduction in Medicaid claims of approximately $29.1 million for the first nine months of 2006.

 

    Truvada

Truvada sales were $309.0 million for the third quarter of 2006, an increase of 90% from Truvada sales in the third quarter of 2005. Sales of Truvada commenced in the United States in the third quarter of 2004 and in the major markets of the European Union during 2005. The increase in sales for the third quarter of 2006 was primarily driven by strong sales volume growth across the major geographic regions.

Truvada sales for the nine months ended September 30, 2006 were $857.2 million, compared to Truvada sales of $376.7 million for the nine months ended September 30, 2005. The increase in sales for the first nine months of 2006 was primarily driven by strong sales volume growth across the major geographic regions.

Truvada sales accounted for 55% and 58% of Gilead’s total HIV product sales for the three and nine months ended September 30, 2006, respectively. In the United States, we expect Truvada sales to begin to level off but remain strong, as we expect Truvada will continue to be the nucleoside reverse transcriptase inhibitor backbone of choice with protease inhibitors.

 

    Viread

Viread sales were $170.6 million in the third quarter of 2006, a 10% decrease from $189.4 million in the third quarter of 2005. Viread sales for the nine months ended September 30, 2006 totaled $529.8 million, a decrease of 11% from $596.3 million for the nine months ended September 30, 2005. Viread sales volume has decreased across major geographic regions due primarily to patients switching from a Viread-containing regimen to one containing Truvada in countries where Truvada is available.

 

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    Atripla

Atripla was approved for sale in the United States in July 2006. Sales were $68.4 million for the three months ended September 30, 2006 and accounted for 12% of Gilead’s total HIV product sales for the three months ended September 30, 2006.

 

    Emtriva

Emtriva sales were $9.3 million for the third quarter of 2006, a 21% decrease from $11.7 million in the third quarter of 2005. Emtriva sales for the nine months ended September 30, 2006 were $27.9 million, compared to $36.3 million for the nine months ended September 30, 2005. These decreases were primarily driven by patients switching from an Emtriva-containing regimen to one containing Truvada in countries where Truvada is available.

For the full year 2006, we expect sales from our HIV product franchise, which now includes Atripla sales in the United States, to be in the range of $2.00 billion to $2.05 billion.

AmBisome

AmBisome sales for the third quarter of 2006 were $55.3 million, an increase of one percent compared to the third quarter of 2005, primarily due to higher sales volume in the United States, partially offset by lower sales volumes in Latin America. We recognized $164.7 million in AmBisome sales for the first nine months of 2006, a slight decrease compared to $165.2 million in the first nine months of 2005. For the full year 2006, we expect AmBisome sales to be in the range of $205.0 million to $215.0 million.

Hepsera

Hepsera sales totaled $55.1 million for the third quarter of 2006, an 18% increase from $46.9 million in the third quarter of 2005. The increase in 2006 was primarily driven by sales volume growth in Europe. Sales of Hepsera totaled $164.6 million for the first nine months of 2006, an increase of 22% over the $135.4 million in the first nine months of 2005. For the first nine months of 2006, sales volume increased 16% over the same period last year primarily driven by volume increases in Europe and in the United States. For the full year 2006, we expect Hepsera sales to be in the range of $215.0 million to $225.0 million.

Royalty and Contract Revenue

For the third quarter of 2006, royalty and contract revenue resulting from collaborations with corporate partners totaled $78.7 million, an increase of $52.4 million from the third quarter of 2005. For the first nine months of 2006, royalty and contract revenue resulting from collaborations with corporate partners totaled $306.8 million, an increase of $203.5 million from the first nine months of 2005. The increase in the three and nine months ended September 30, 2006 was primarily driven by the recognition of Tamiflu royalties from Roche during those periods of $62.7 million and $251.3 million, respectively. These royalties were significantly higher than the Tamiflu royalties of $12.1 million and $60.2 million recognized in the three and nine months ended September 30, 2005, respectively, due to the significantly higher Tamiflu sales recorded by Roche during the fourth quarter of 2005 and the first and second quarters of 2006 compared to the same periods in 2004 and 2005, as well as the elimination of a contractual cost of goods adjustment that had historically reduced the amount of Tamiflu royalties recognized by Gilead. Roche reported their third quarter 2006 financial results on October 17, 2006, at which time they provided an update on their guidance for government sales of Tamiflu for pandemic planning purposes. Roche’s revised guidance for the full year 2006 is 1.6 to 1.7 billion Swiss francs, up from their guidance provided in the previous quarter of 1.2 to 1.3 billion Swiss francs. As we recognize royalties on Tamiflu sales the quarter following the quarter in which it is sold, Gilead expects to receive royalties from Roche at the rate of 22% of net sales after certain adjustments in the fourth quarter of this year. In addition, during the quarter ended September 30, 2006, we received a $5.0 million milestone payment from GSK, associated with achieving four consecutive quarters of Hepsera gross sales exceeding $75.0 million in GSK territories. This amount has been recorded as deferred revenue to be amortized into contract revenue over the life of our manufacturing supply agreement with GSK.

Cost of Goods Sold and Product Gross Margin Percentage

The following table summarizes the period over period changes in our cost of goods sold (in thousands) and product gross margin percentages:

 

   

Three Months Ended

September 30,

  Change  

Nine Months Ended

September 30,

  Change
    2006   2005     2006   2005  

Total product sales

  $     670,060   $     467,204   43%   $     1,820,104   $     1,315,873   38%

Cost of goods sold

    109,791     65,498   68%     278,031     186,182   49%

Product gross margin percentage

    84%     86%       85%     86%  

Our product gross margin percentage for the third quarter of 2006 was 84%, compared to 86% for the same quarter of 2005. The lower gross margin percentage was primarily due to product mix changes which included the impact of the launch of Atripla in the United States, and the inclusion of stock-based compensation expense from our adoption of SFAS 123R, partially offset by the higher average selling prices of our HIV products in the United States as some Medicaid patients began transitioning to Medicare Part D, which reduces the amount of Medicaid claims. Our product gross margin percentage for the first nine months of 2006 was 85%, compared to 86% for the same period in 2005. The lower gross margin percentage was primarily due to the factors mentioned above, as well as the $6.8 million charge to cost of goods sold in the first quarter of 2006 to write-down the inventory for our Gilead Access Program to its estimated net realizable value.

 

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The Atripla product decreases our product gross margin percentage, but without a corresponding impact to our net profit. As the primary beneficiary of our joint venture with BMS, we consolidate 100% of Atripla product sales but only benefit from the product margin on the Truvada portion of Atripla. The Sustiva portion of Atripla product sales carries a zero product gross margin since the joint venture purchases Sustiva API from BMS at BMS’s estimated net selling price of Sustiva in the U.S. market.

We expect our product gross margin percentage for 2006 to be in the range of 84% to 85%. This includes the impact of our adoption of SFAS 123R and the launch of Atripla in the United States in July 2006.

Research and Development Expenses

The following table summarizes the period over period changes in our R&D expenses into these major components (in thousands):

 

    

Three Months Ended

September 30,

   Change   

Nine Months Ended

September 30,

   Change
     2006    2005       2006    2005   

Research

   $ 21,931    $ 15,165    45%    $ 62,167    $ 39,903    56%

Clinical development

     57,612      49,313    17%      168,357      137,547    22%

Pharmaceutical development

     13,762      14,352    (4)%      41,717      31,511    32%
                                 

Total research and development

   $     93,305    $     78,830    18%    $     272,241    $     208,961    30%
                                 

R&D expenses for the third quarter of 2006 were $93.3 million compared to $78.8 million for the same quarter in 2005. R&D expenses for the third quarter of 2006 were higher primarily due to stock-based compensation expense of $13.3 million from our adoption of SFAS 123R on January 1, 2006, increased contract service and clinical study expenses of $9.3 million relating to clinical, product development and research activities with our hepatitis C, hepatitis B and HIV programs and increased compensation and benefits of $5.6 million due largely to higher headcount. In the third quarter of 2005, we incurred a $15.0 million payment to Emory in connection with the amendment of our existing license agreement with Emory related to our obligation to develop emtricitabine for the hepatitis B indication.

R&D expenses for the first nine months of 2006 and 2005 were $272.2 million and $209.0 million, respectively. R&D expenses for the first nine months of 2006 were higher primarily due to stock-based compensation expense of $38.1 million from our adoption of SFAS 123R on January 1, 2006, increased contract service and clinical study expenses of $33.8 million relating to clinical, product development and research activities with our hepatitis C, hepatitis B and HIV programs and increased compensation and benefits of $10.0 million due largely to higher headcount. In general, significant collaboration payments during a period can cause our R&D expenses to fluctuate. During the first nine months of 2006, we incurred a milestone payment of $5.0 million related to the dosing of the first patient in a Phase 2 clinical study for our lead integrase inhibitor, GS 9137, under our collaboration agreement with Japan Tobacco. In comparison, in the first nine months of 2005, we incurred an upfront payment of $15.0 million to Japan Tobacco related to the signing of this same agreement as well as a $15.0 million payment to Emory mentioned above.

For the full year 2006, we expect our R&D expenses to be in the range of $365.0 million to $385.0 million. This includes the impact of our adoption of SFAS 123R and operating expenses associated with our Seattle operations as a result of the Corus acquisition, but excludes any additional R&D expenses for potential new collaborations or product licensing activity as well as expenses related to the Myogen acquisition.

Selling, General and Administrative Expenses

The following summarizes the period over period changes in our selling, general and administrative (SG&A) expenses (in thousands):

 

    

Three Months Ended

September 30,

   Change   

Nine Months Ended

September 30,

   Change
     2006    2005       2006    2005   

Selling, general and administrative

   $     132,529    $     100,873    31%    $     426,567    $     274,765    55%

SG&A expenses for the third quarter of 2006 were $132.5 million compared to $100.9 million for the same quarter in 2005. The higher SG&A expenses in the third quarter of 2006 as compared to the same quarter of 2005 were primarily due to stock-based compensation expense of $16.0 million from our adoption of SFAS 123R on January 1, 2006, increased expenses of $10.1 million in contract services, grants and promotional programs relating to our significant business growth and business development activities, and increased compensation and benefits of $7.9 million due largely to higher headcount. In the third quarter of 2005, we incurred $8.4 million of accrued severance and relocation expenses related to the relocation of our European commercial, medical and administrative headquarters from France to the United Kingdom. In addition, beginning in 2006, we began reporting net foreign exchange transaction gains or losses as well as fair value changes on derivative instruments not designated as hedges in interest and other income, net. These amounts, which were previously reported as SG&A expenses, were reclassified to enhance the comparability of our financial statements with those of other companies. Prior year amounts, although insignificant, have been reclassified to be consistent with the current year presentation.

 

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For the first nine months of 2006 and 2005, SG&A expenses were $426.6 million and $274.8 million, respectively. The higher SG&A expenses were primarily due to increased expenses of $55.1 million in contract services, grants and promotional programs relating to our significant business growth, business development activities and preparation for our launch of Atripla, stock-based compensation expense of $51.8 million from our adoption of SFAS 123R on January 1, 2006, increased compensation and benefits of $22.8 million due largely to higher headcount, and the $7.9 million write-off of certain capital assets related to campus renovations.

In March 2006, we initiated an evaluation of our European distribution framework outside of our existing European subsidiaries. As a result, we initiated contact with certain of our European distributors with our intent to ultimately terminate these distribution agreements. This process may entail lengthy negotiations with these distributors. Although it is probable that we will incur contract termination costs, we are currently unable to reasonably estimate such costs in accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities , and as such, no amount has been accrued related to the outcome of these negotiations. When the amounts become estimable, we will record such costs in SG&A expenses.

For the full year 2006, we expect our SG&A expenses to be in the range of $555.0 million to $575.0 million. This includes the impact of our adoption of SFAS 123R, as well as operating expenses associated with our Seattle operations as a result of the Corus acquisition, but excludes expenses related to the Myogen acquisition.

Purchased In-Process Research and Development Expense

In connection with our acquisition of Corus, we recorded purchased IPR&D expense of $355.6 million for the three and nine months ended September 30, 2006, representing the estimated fair value of Corus’s incomplete aztreonam lysine for cystic fibrosis research and development program that had not yet reached technological feasibility and had no alternative future use as of the acquisition date. A description of this program at the acquisition date is as follows:

 

Program

  

Description

  

Status of Development

  

Estimated
Acquisition
Date Fair
Value

(in millions)

Aztreonam lysine for cystic fibrosis

   Aztreonam formulation for inhalation to be used against Gram-negative bacteria that cause lung infections in patients with cystic fibrosis.    Phase 3 clinical trials at acquisition date. We expect to file a NDA with the FDA in late 2007.    $ 355.6

The remaining efforts for completion of Corus’s R&D project primarily consist of clinical trials, the cost, length and success of which are extremely difficult to predict. Numerous risks and uncertainties exist that could prevent completion of development, including the ability to enroll patients in clinical trials, the possibility of unfavorable results of our clinical trials, and the risk of failing to obtain FDA and other regulatory body approvals. Feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. We cannot be certain that aztreonam lysine for cystic fibrosis, purchased from Corus, will be approved in the United States or the European Union or whether marketing approvals will have significant limitations on its use. Future discussions with regulatory agencies will determine the amount of data needed and timelines for review, which may differ materially from current projections. The acquired product candidate under development may never be successfully commercialized. As a result, we may make a strategic decision to discontinue development of this product candidate, if we believe commercialization will be difficult relative to other opportunities in our pipeline. If this program cannot be completed on a timely basis or at all, then our prospects for future revenue growth would be adversely impacted.

The value of the purchased IPR&D was determined by estimating the related future net cash flows using a present value risk adjusted discount rate of 16%. This discount rate is a significant assumption and is based on the estimated internal rate of return for Corus’s operations and is comparable to the estimated weighted average cost of capital for companies in Corus’s industry. The projected cash flows from the aztreonam program were based on estimates of revenues and operating profits related to the program considering its stage of development, the time and resources needed to complete the development and approval of the related product, the life of the potential commercialized product and associated risks including the inherent difficulties and uncertainties in developing a drug compound including obtaining FDA and other regulatory approvals, and risks related to the viability of and potential alternative treatments in any future target markets. Corus’s two other early-stage candidates were not included in the valuation of the purchased IPR&D because they were early-stage projects that did not have identifiable revenues and expenses associated with them.

Interest and Other Income, net

Including the reclassification of net foreign exchange transaction gains or losses mentioned above, interest and other income, net, was $36.2 million for the third quarter of 2006, up from $14.1 million for the third quarter of 2005. Including the effect of the reclassification discussed above, interest and other income, net, totaled $102.1 million and $31.2 million for the first nine months of 2006 and 2005, respectively. The increase in 2006 compared to the same periods in 2005 was primarily due to higher investment balances and interest rates in 2006, which was partially offset by the recognition of $6.6 million of other-than-temporary loss associated with marketable securities that we expect to liquidate in order to fund the $2.5 billion acquisition of Myogen anticipated to close in the fourth quarter of 2006.

 

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Interest Expense

Interest expense for the three and nine months ended September 30, 2006 was $6.1 million and $15.0 million, respectively, which was due primarily to interest on our term loan which we entered into in December 2005.

Minority Interest in Joint Venture

The minority interest in joint venture on our condensed consolidated financial statements reflects BMS’s interest in the operating results of our joint venture with BMS in the United States. The operations of the joint venture commenced in 2005 with activities primarily focusing on the co-formulation of the once-daily single tablet regimen and achieving bioequivalence with the various co-formulations. We achieved bioequivalence on a formulation of the single tablet regimen at the end of 2005, and we filed an NDA for the single tablet regimen in April 2006. In July 2006, we received approval from the FDA for this single tablet regimen, which has been given the trade name Atripla.

Provision for Income Taxes

Our effective tax rate for three and nine months ended September 30, 2006 was 158.4% and 46.3%, respectively. Included in our operating income in the third quarter of 2006 was a pre-tax charge of $355.6 million for purchased IPR&D expense associated with our Corus acquisition. We did not record any income tax benefit related to the purchased IPR&D charge as such amount is non-deductible. Our effective income tax rate was 32.0% for each of the three and nine months ended September 30, 2005. Our provision for income taxes for the third quarter of 2006 was $141.5 million compared to $84.3 million for the third quarter of 2005. Our provision for income taxes for the first nine months of 2006 was $409.8 million compared to $250.5 million for the first nine months of 2005. The effective tax rate for the first nine months of 2006 varied from the statutory rate primarily as a result of our non-deductible purchased IPR&D expense, permanently reinvested earnings of our foreign operations and the tax impact of stock-based compensation expensing under SFAS 123R. We do not provide for U.S. income taxes on undistributed earnings of our foreign operations that are intended to be permanently reinvested.

Various factors may have favorable or unfavorable effects on our income tax rate. These factors include, but are not limited to, interpretations of existing tax laws, our adoption of SFAS 123R relating to the accounting for stock options and other share-based payments, changes in tax laws and rates, mergers and acquisitions, future levels of research and development spending, changes in accounting standards, future levels of capital expenditures, changes in the mix of earnings in the various tax jurisdictions in which we operate and changes in overall levels of pre-tax earnings.

In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48), an interpretation of SFAS No. 109, Accounting for Income Taxes (SFAS 109). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS 109 and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. We are still evaluating what impact, if any, the adoption of this standard will have on our consolidated financial statements.

Liquidity and Capital Resources

The following table summarizes our cash, cash equivalents and all marketable securities, our working capital, and our statements of cash flows (in thousands):

 

     September 30,
2006
    December 31,
2005
 

Cash, cash equivalents and all marketable securities

   $ 3,204,443     $ 2,311,033  

Working capital

   $ 3,450,571     $ 2,627,045  
    

Nine Months Ended

September 30,

 
     2006     2005  

Cash provided by (used in):

    

Operating activities

   $ 738,551     $ 369,292  

Investing activities

   $     (1,501,864 )   $     (199,467 )

Financing activities

   $ 629,834     $ 106,991  

 

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Cash, Cash Equivalents and All Marketable Securities

Cash, cash equivalents and all marketable securities totaled $3.20 billion at September 30, 2006, an increase of 39% from December 31, 2005. The increase of $893.4 million was primarily attributable to $738.6 million of operating cash flows generated during the first nine months of 2006 and $587.6 million of net proceeds generated from our issuance of convertible senior notes and related transactions, partially offset by cash paid for the acquisition of Corus net assets of $356.2 million and $161.0 million paid towards principal on our term loan. As a result of our issuance of the convertible senior notes and related transactions in April 2006, our cash, cash equivalents and all marketable securities increased significantly. We believe that, when the net proceeds from these transactions are considered together with our existing cash, cash equivalents and all marketable securities and our available credit facility, we have the ability to hold the marketable securities in our portfolio until their respective maturities. Accordingly, during the quarter ended June 30, 2006, we began classifying our marketable securities as short-term or long-term according to their contractual maturities.

Working Capital

Working capital at September 30, 2006 was $3.45 billion compared to $2.63 billion at December 31, 2005. The increase of $823.5 million was primarily due to the following:

 

    $542.9 increase in cash, cash equivalents and short-term marketable securities primarily due to the increase in our marketable securities portfolio, partially offset by a decrease resulting from the classification of certain of our marketable securities into noncurrent assets as discussed above;

 

    $188.9 million increase in accounts receivable primarily due to increased sales during the first nine months of 2006 ;

 

    $156.4 million increase in inventory and $136.9 million increase in accounts payable primarily due to the launch of Atripla and the related purchases of Sustiva API from BMS at BMS’s approximate market value of Sustiva; and

 

    $95.7 million decrease in income taxes payable primarily due to the payment of income taxes in the first nine months of 2006.

Cash Provided by Operating Activities

Cash provided by operating activities for the nine months ended September 30, 2006 was comprised primarily of net income of $475.7 million, non-cash purchased IPR&D expense of $355.6 million, non-cash stock-based compensation expense of $98.1 million, tax benefits related to employee stock plans of $107.5 million and non-cash depreciation and amortization of $35.5 million, partially offset by a $288.9 million net cash outflow related to changes in operating assets and liabilities. Operating cash flows also included a non-cash outflow of $79.8 million related to excess tax benefits from stock option exercises, which is now classified as a financing cash flow in accordance with SFAS 123R. Cash provided by operating activities for the nine months ended September 30, 2005 included $532.3 million of net income, a non-cash change in deferred tax assets of $67.9 million and a $333.2 million net cash outflow related to changes in operating assets and liabilities.

Cash Used in Investing Activities

Cash used in investing activities primarily related to purchases, sales and maturities of available-for-sale securities and our acquisition of the net assets of Corus. We used $2.29 billion of cash for investing activities during the first nine months of 2006, compared to $1.14 billion during the same period in 2005. Net cash used for purchases of available-for-sale securities increased in the first nine months of 2006 to $1.04 billion, compared to $164.6 million in the first nine months of 2005. During the first nine months of 2006, net cash used in investing also included $356.2 million related to our acquisition of Corus net assets, $75.0 million of capital expenditures, a $23.0 million deposit we paid to Degussa associated with our acquisition of Raylo and $8.7 million invested in non-marketable securities issued by certain of our strategic partners.

Capital expenditures made in the first nine months of 2006 totaled $75.0 million and related to the purchase of two facilities that we were previously leasing at our Foster City campus, expanding certain aspects of our manufacturing capabilities, the general upgrade of our facilities, as well as additional spending on computer and laboratory equipment to accommodate our growth. Capital expenditures made in the first nine months of 2005 totaled $34.9 million primarily related to domestic facilities improvements and purchases of laboratory and manufacturing equipment.

Cash Provided by Financing Activities

Cash provided by financing activities in the first nine months of 2006 was $629.8 million primarily from the $587.6 million of net proceeds generated from our issuances of convertible senior notes and related transactions. In addition, we received proceeds from employee stock option exercises of $123.8 million, as well as $79.8 million of excess tax benefits from stock option exercises. This was partially offset by $161.0 million paid towards principal on our term loan during the first nine months of 2006. Cash provided by financing activities in the first nine months of 2005 was $107.0 million due primarily to proceeds from employee stock option exercises.

 

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Other Information

As of September 30, 2006, we had an uncollateralized revolving credit facility of $361.0 million of which there were no outstanding amounts. The capacity of the revolving credit facility will continue to increase to a maximum of $500.0 million commensurate with the repayments of principal under our term loan.

In November 2006, we completed the acquisition of Raylo from Degussa for approximately €107.1 million (approximately $136 million). In June 2006, we also entered into a seven-year supply agreement with Degussa for the manufacture and supply of API for certain of our products in which we are obligated to purchase API valued at approximately €177.0 million (approximately $221.8 million).

In October 2006, we signed a definitive agreement with Myogen, under which we plan to acquire Myogen in a cash transaction for approximately $2.5 billion. We expect the acquisition to close in the fourth quarter of 2006, subject to the satisfaction of certain closing conditions.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that are currently material or reasonably likely to be material to our financial position or results of operations.

 

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no significant changes in our market risk as of September 30, 2006 compared to the disclosures in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2005.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

An evaluation as of September 30, 2006 was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our “disclosure controls and procedures,” which are defined under SEC rules as controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within required time periods. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that subject to the limitations described below, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in this quarterly report on Form 10-Q was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules on Form 10-Q.

Changes in Internal Control over Financial Reporting

Our management, including our Chief Executive Officer and Chief Financial Officer, has evaluated any changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2006, and has concluded that there was no change during such quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Controls

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our Chief Executive Officer and Chief Financial Officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were sufficiently effective to provide reasonable assurance that the objectives of our disclosure control system were met.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in “Item 1. Condensed Consolidated Financial Statements – Note 10. Contingencies - Legal Proceedings” to the interim condensed consolidated financial statements, and is incorporated by reference herein.

ITEM 1A. RISK FACTORS

Substantially all of our revenues are derived from sales of a limited number of products. If we are unable to maintain or continue increasing sales of our HIV products, our results of operations may be adversely affected.

We are currently dependent on sales of our HIV products, especially Viread and Truvada, to support our existing operations. Our HIV products are exclusively of the nucleoside class of antiviral therapeutics. Were the treatment paradigm for HIV to change, causing nucleoside-based therapeutics to fall out of favor, or if we are unable to continue increasing our HIV product sales, our results of operations would likely suffer and we would likely need to scale back our operations, including our spending on research and development (R&D) efforts. HIV product sales for the three months ending September 30, 2006 were $557 million, or 74% of our total revenues, and sales of Truvada and Viread comprised 55% and 31%, respectively, of total HIV product sales for the third quarter of 2006. Our sales of HIV products and other products may decline for the reasons stated in this risk factor section and, in particular, for the following reasons:

 

    As our HIV products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues.

 

    As a product matures, private insurers and government reimbursers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices.

 

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    A large part of the market for our HIV products consists of patients who are already taking other HIV drugs. If we are not successful in encouraging physicians to change patients’ regimens to include our HIV products, the sales of our HIV products will be limited.

 

    As generic HIV products are introduced into major markets, our ability to maintain pricing may be affected.

If we fail to commercialize new products or expand the indications for existing products, our prospects for future revenues and our stock price may be adversely affected.

If we do not introduce new products or increase revenues from our existing products, we will not be able to increase our total revenues. Each new product commercialization effort will face the risks outlined in this section. If we fail to increase our sales of our HIV products, we may not be able to increase revenues and expand our R&D efforts. Although our joint venture with BMS launched the single tablet regimen of Truvada and Sustiva, trade named Atripla, in July 2006 in the United States, physicians may be reluctant to prescribe Atripla if they fail to see advantages of the single tablet regimen over other antiretrovirals and as a result, we may not be able to increase revenues. Furthermore, product sales of Atripla may increase at the expense of product sales of its component products and our overall total revenues may not increase from the launch of Atripla.

We face significant competition.

We face significant competition from businesses that have substantially greater resources than we do. In addition, our competitors have more products and have operated in the fields in which we compete for longer than we have. Our HIV products compete primarily with products from GSK, which markets fixed-dose combination products that compete with Truvada and Atripla. For AmBisome, we are encountering significant competition from new products produced by Merck & Co., Inc. and Pfizer Inc. (Pfizer). In addition, we are aware of reports of at least three lipid formulations that claim similarity to AmBisome becoming available outside of the United States, including the anticipated entry of one such formulation in Greece. These formulations may reduce market demand for AmBisome and if any of these formulations are found to be unsafe, sales of AmBisome may be negatively impacted. For Hepsera, we have encountered increased competition with the launch of BMS’s Baraclude (entecavir) and there is the potential for future competition from telbivudine, developed by Novartis Pharmaceuticals Corporation and Idenix Pharmaceuticals Limited, which is awaiting approval in the United States and Europe. These companies have substantially greater resources than we do and may significantly impede our ability to be successful with our antiviral products and AmBisome.

If significant safety issues arise for our marketed products, our sales may decline, which would adversely affect our results of operations.

The data that support the marketing approvals for our products and that form the basis for the safety warnings in our product labels were obtained in controlled clinical trials of limited duration and, in some cases, from limited post-approval use. As our products, including Truvada, Viread, Atripla, Emtriva, AmBisome and Hepsera, are used over longer periods of time by many patients taking numerous other medicines, many of whom have underlying health problems and would not be monitored for dosing compliance. As drugs are used over longer periods of time by more patients, we have found and expect to continue to find new issues such as safety, resistance or drug interaction issues, which may require us to provide additional warnings or contraindications on our labels or narrow our approved indications, each of which could reduce the market acceptance of these products. Safety and efficacy studies of Viread and Emtriva, dosed as separate products, are ongoing and have been underway for a longer period of time than the safety and efficacy studies of Truvada (Viread and Emtriva together), which are also underway. We expect to conduct similar studies using Atripla. If serious safety, resistance or interaction issues arise with our marketed products, sales of these products could be limited or halted by us or by regulatory authorities.

Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to achieve continued compliance could delay or halt commercialization of our products.

The products that we develop must be approved for marketing and sale by regulatory authorities and, once approved, are subject to extensive regulation by the FDA and comparable regulatory agencies in other countries. We are continuing clinical trials for Truvada, Viread, Atripla, Emtriva, AmBisome and Hepsera for currently approved and additional uses. We anticipate that we will file for marketing approval in additional countries and for additional products over the next several years. These products may fail to receive marketing approval on a timely basis, or at all.

In addition, our marketed products and how we manufacture and sell these products are subject to extensive continued regulation and review. Discovery of previously unknown problems with our marketed products or problems with our manufacturing or promotional activities may result in restrictions on our products, including withdrawal of the products from the market. If we fail to comply with applicable regulatory requirements, we could be subject to penalties including fines, suspensions of regulatory approvals, product recalls, seizure of products and criminal prosecution.

 

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We depend on contract research organizations and our results of clinical trials are uncertain and may not support continued development of a product pipeline, which would adversely affect our prospects for future revenue growth.

Gilead extensively outsources its clinical trial activities and usually performs only a small portion of the start-up activities in-house. We rely on third-party contract research organizations (CROs) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training and program management. If there is any dispute or disruption in our relationship with our CROs, our clinical trials may be delayed. In addition, we are required to demonstrate the safety and effectiveness of products we develop in each intended use through extensive preclinical studies and clinical trials. The results from preclinical and early clinical studies do not always accurately predict results in later, large-scale clinical trials. Even successfully completed large-scale clinical trials may not result in marketable products. If any of our products under development fails to achieve its primary endpoint in clinical trials or if safety issues arise, commercialization of that drug candidate could be delayed or halted. In addition, clinical trials involving our commercial products could raise new safety issues for our existing products, which could in turn reduce our revenues.

We recently completed the acquisitions of Corus and Raylo, and expect to complete the acquisition of Myogen during the fourth quarter of 2006.

Integrating these businesses with our existing business will be a complex and time-consuming process. Myogen and until recently, Corus and Raylo, operate independently of Gilead, each with its own business, corporate culture, locations, employees and systems. Following each of these acquisitions, we will have to operate our existing business, along with the businesses of Corus, Raylo and Myogen, as one combined organization utilizing common information and communication systems, operating procedures, financial controls and human resources practices, including benefits, training and professional development programs. There may be substantial difficulties, costs and delays involved in the integration of these companies with Gilead and the integration with Gilead of any other company or assets that Gilead may from time to time acquire. The failure to integrate these companies with Gilead successfully, or any other assets or companies we may acquire, may have a material adverse effect on our business, financial condition and results of operations.

The remaining efforts for completion of Corus’s R&D project primarily consist of clinical trials, the cost, length and success of which are extremely difficult to predict. Numerous risks and uncertainties exist that could prevent completion of development, including the ability to enroll patients in clinical trials, the possibility of unfavorable results of our clinical trials, and the risk of failing to obtain FDA and other regulatory body approvals. Feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. We cannot be certain that aztreonam lysine for cystic fibrosis, purchased from Corus, will be approved in the United States or the European Union or whether marketing approvals will have significant limitations on its use. Future discussions with regulatory agencies will determine the amount of data needed and timelines for review, which may differ materially from current projections. The acquired product candidate under development may never be successfully commercialized. As a result, we may make a strategic decision to discontinue development of this product candidate, if we believe commercialization will be difficult relative to other opportunities in our pipeline. If this program cannot be completed on a timely basis or at all, then our prospects for future revenue growth would be adversely impacted.

Manufacturing problems could delay product shipments and regulatory approvals, which may adversely affect our results of operations.

We depend on third parties to perform manufacturing activities effectively and on a timely basis for Truvada, Viread, Atripla, Emtriva, Hepsera and Vistide. The manufacturing process for pharmaceutical products is highly regulated, and regulators may shut down manufacturing facilities that they believe do not comply with regulations. We and our manufacturers are subject to the FDA’s current Good Manufacturing Practices, which are extensive regulations governing manufacturing processes, stability testing, record-keeping and quality standards and similar regulations are in effect in other countries. Our manufacturing operations are also subject to routine inspections by regulatory agencies. Additionally, our third party manufacturers are independent entities who are subject to their own unique operational and financial risks which are out of our control. To the extent that these risks materialize and affect their performance obligations to us, it may adversely affect our financial results.

We also depend on these third party manufacturers to manufacture the Truvada, Viread and Atripla made available to physicians and treatment programs at cost in developing countries under our Access Program. We rely on these third parties for the manufacture of both the API and final drug product for clinical and commercial purposes. In addition, Roche, either by itself or through third parties, is responsible for manufacturing Tamiflu. If these third parties fail to perform as required, this could impair our ability to deliver our products on a timely basis or receive royalties or cause delays in our clinical trials and applications for regulatory approval. These events could harm our competitive position and financial results.

We manufacture AmBisome and fill and finish Macugen only at our facilities in San Dimas, California. Business interruptions at our San Dimas facility could adversely affect our business.

These are our only formulation and manufacturing facilities in the United States. We own a manufacturing facility in Ireland that conducts quality control testing, labeling and packaging. In addition, we use third parties as alternate contract suppliers to fill and freeze dry certain batches of product. In the event of a natural disaster, including an earthquake, equipment failure, strike or other difficulty, we may be unable to replace this manufacturing capacity in a timely manner and may be unable to manufacture AmBisome and Macugen to meet market needs.

We may not be able to obtain materials necessary to manufacture our products, which could limit our ability to generate revenues.

Many of the materials that we utilize in our operations are made at only one facility. For example, we depend on single suppliers for high quality amphotericin B, distearoylphosphatidylcholine and high quality cholesterol, each of which is used in the manufacture of AmBisome. Because the suppliers of key components and materials must be named in the NDA filed with the FDA for a product, significant delays can occur if the qualification of a new supplier is required. If delivery of material from our suppliers were interrupted for any reason, we may be unable to ship Truvada, Viread, Atripla, Emtriva, AmBisome, Hepsera or Vistide, or to supply any of our products in development for clinical trials.

 

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We depend on relationships with other companies for sales and marketing performance and revenues. Failure to maintain these relationships, poor performance by these companies or disputes with these other companies could negatively impact our business.

We rely on a number of significant collaborative relationships with major pharmaceutical companies for our sales and marketing performance in certain territories. These include collaborations with Astellas Pharma, Inc. (created through the merger of Yamanouchi Pharmaceutical Co. Ltd. and Fujisawa Pharmaceutical Co., Ltd.) and Dainippon Sumitomo Pharma Co., Ltd. for AmBisome, GSK for Hepsera, Roche for Tamiflu, Pfizer for Vistide, OSI and Pfizer for Macugen, Japan Tobacco for Viread, Truvada and Emtriva and our joint venture with BMS for Atripla, the single tablet regimen of Truvada and Sustiva. In many countries, we rely on international distributors for sales of Truvada, Viread, Emtriva, AmBisome and Hepsera. Some of these relationships also involve the clinical development of these products by our partners. Reliance on collaborative relationships poses a number of risks, including:

 

    the risk that we are not able to control the resources our corporate partners devote to our programs or products;

 

    disputes may arise with respect to the ownership of rights to technology developed with corporate partners;

 

    disagreements with corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration;

 

    contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform;

 

    corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;

 

    corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and

 

    our distributors and corporate partners may be unable to pay us.

Given these risks, there is a great deal of uncertainty regarding the success of our current and future collaborative efforts. If these efforts fail, our product development or commercialization of new products could be delayed or revenue from existing products could decline.

Under our April 2002 licensing agreement with GSK, we gave GSK the right to control clinical and regulatory development and commercialization of Hepsera in territories in Asia, Africa and Latin America. These include major markets for Hepsera, such as China, Japan, Taiwan and The Republic of Korea. The success of Hepsera in these territories will depend almost entirely on the efforts of GSK.

In this regard, GSK promotes Epivir-HBV/Zeffix, a product that competes with Hepsera. Consequently, GSK’s marketing strategy for Hepsera may be influenced by its promotion of Epivir-HBV. We receive royalties from GSK equal to a percentage of GSK’s net sales of Hepsera as well as net sales of GSK’s Epivir-HBV/Zeffix.

If GSK fails to devote sufficient resources to, or does not succeed in developing or commercializing Hepsera in its territories, our potential revenues from sales of Hepsera may be substantially reduced.

Expenses associated with clinical trials and sales fluctuations as a result of inventory levels held by wholesalers may cause our earnings to fluctuate, which could adversely affect our stock price.

The clinical trials required for regulatory approval of our products, as well as clinical trials we are required to conduct after approval, are extremely expensive. It is difficult to accurately predict or control the amount or timing of these expenses from quarter to quarter. Uneven and unexpected spending on these programs may cause our operating results to fluctuate from quarter to quarter.

We estimate the future demand for our product, consider the shelf life of our inventory and regularly review the realizability of our inventory. If actual demand is less than our estimated demand, we could be required to record inventory write-downs, which would have an adverse impact on our results of operations. For example, as a result of our review of inventory realizability, during the first quarter of 2006, we recorded a write-down of a portion of our Access Program inventory. Additional write downs of inventory for our Access Program may be necessary if demand for our HIV products in the Access Program countries is not sufficient to consume existing inventories.

During the third quarter of 2006, approximately 83% of our product sales in the United States were to three wholesalers, AmerisourceBergen Corp., Cardinal Health, Inc. and McKesson Corp. Inventory levels held by those wholesalers can cause our operating results to fluctuate unexpectedly if our sales to wholesalers do not match end user demand. The U.S. wholesalers with whom

 

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we have entered into inventory management agreements may not be completely effective in matching inventory levels to end user demand, as they make estimates to determine end user demand. The non-retail sector in the United States, which includes government institutions, correctional facilities and large health maintenance organizations, which currently contributes to approximately 25% to 30% of our HIV business, tends to be less consistent in terms of buying patterns, and often results in quarter over quarter fluctuations that do not necessarily mirror the growth patterns that can be seen in the retail prescription data. The unpredictable variability of Roche’s Tamiflu sales and the strong relationship between this revenue and global pandemic planning and supply also cause our royalty revenues to fluctuate from quarter to quarter.

Our success will depend to a significant degree on our ability to protect our patents and other intellectual property rights both domestically and internationally.

We have a number of patents, patent applications and rights to patents related to the compounds in our products, but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents. Competitors may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block or compete with our patents. Patent applications are confidential for at least some period of time until a patent issues. As a result, we may not know if our competitors filed patent applications for technology covered by our pending applications or if we were the first to invent the technology that is the subject of our patent applications. If competitors file patent applications covering our technology, we may have to participate in interference proceedings or litigation to determine the right to a patent. Litigation and interference proceedings are expensive even if we are ultimately successful.

As part of the approval process of some of our products, the FDA has determined that the products would be granted an exclusivity period during which other manufacturers’ applications for approval of our products will not be granted. Generic manufacturers often wait to challenge the patents protecting products until one year prior to the end of the exclusivity period. From time to time, we have received notices from manufacturers indicating that they intend to import chemical intermediates possibly for use in making our products. It is, therefore, possible that generic manufacturers are considering attempts to seek FDA approval for a similar or identical drug through an Abbreviated NDA, which is the application form typically used by manufacturers seeking approval of a generic drug. If our patents are subject to challenges, we may need to spend significant resources to defend such challenges and we may not be able to defend our patents successfully.

We may not be able to obtain effective patents to protect our technologies from use by competitors and patents of other companies could require us to stop using or pay for the use of required technology.

Our success will depend to a significant degree on our ability to:

 

    obtain patents and licenses to patent rights;

 

    preserve trade secrets; and

 

    operate without infringing on the proprietary rights of others.

We may obtain patents for certain products many years before marketing approval is obtained for those products. Because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited. However, we may be able to apply for patent term extensions. In addition, certain countries in Africa and Asia, including China, do not permit enforcement of our patents, and manufacturers are able to sell generic versions of our products in those countries.

Our success depends in large part on our ability to operate without infringing upon the patents or other proprietary rights of third parties.

If we infringe the patents of others, we may be prevented from commercializing products or may be required to obtain licenses from these third parties. We may not be able to obtain alternative technologies or any required license on reasonable terms or at all. If we fail to obtain such licenses or alternative technologies, we may be unable to develop or commercialize some or all of our products.

In addition, we use significant proprietary technology and rely on unpatented trade secrets and proprietary know-how to protect certain aspects of our production and other technologies. Our trade secrets may become known or independently discovered by our competitors.

Approximately half of our product sales occur outside the United States, and currency fluctuations may cause our earnings to fluctuate, which could adversely affect our stock price.

A significant percentage of our product sales are denominated in foreign currencies, primarily the Euro. Increases in the value of the U.S. dollar against foreign currencies in the past have reduced, and in the future may reduce the value of our U.S. dollar equivalent sales and negatively impact our financial condition and results of operations. We use foreign currency forward contracts to hedge a

 

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percentage of our forecasted international sales, primarily those denominated in the Euro currency. We also hedge a portion of our accounts receivable balances denominated in foreign currencies, which reduces but does not eliminate our exposure to currency fluctuations between the date a sale is recorded and the date that cash is collected. Our hedging program only hedges a portion of our total exposure and significant foreign exchange rate fluctuations within a short period of time could still adversely affect our results of operations.

We face credit risks from our European customers that may adversely affect our results of operations.

Our European product sales to government owned or supported customers in Greece, Italy, Portugal and Spain are subject to significant payment delays due to government funding and reimbursement practices. Our accounts receivable from government owned or supported customers in these countries totaled $300.5 million as of September 30, 2006. Historically, receivables tend to accumulate over a period of time and then are settled through large lump sum payments as government funding becomes available. If significant changes were to occur in the reimbursement practices of European governments or if government funding becomes unavailable, we may not be able to collect on amounts due to us from these customers and our results of operations would be adversely affected. From time to time, we also enter into non-recourse factoring arrangements which subject us to charges which could adversely affect our results of operations.

Our product revenues could be reduced by imports from countries where our products are available at lower prices.

Prices for our products are based on local market economics and competition and sometimes differ from country to country. Our sales in countries with relatively higher prices may be reduced if products can be imported into those or other countries from lower price markets. There have been cases in which pharmaceutical products were sold at steeply discounted prices in the developing world and then re-exported to European countries where they could be re-sold at much higher prices. If this happens with our products, particularly Truvada and Viread, which we have agreed to make available at no-profit prices to 97 countries participating in our Access Program, our revenues would be adversely affected. In addition, we have granted non-exclusive, voluntary licenses for the manufacture of tenofovir disoproxil fumarate to 11 generic manufacturers in India for the local Indian market and for manufacturers to export product to 95 of the developing world countries included in our Access Program. If generic versions of Viread under these licenses are then re-exported to the United States, Europe or other markets outside of India or the 97 developing world countries participating in our Access Program, our revenues would be adversely affected.

In addition, in the European Union, we are required to permit cross-border sales. This allows buyers in countries where government-approved prices for our products are relatively high to purchase our products legally from countries where they must be sold at lower prices. Additionally, some U.S. consumers have been able to purchase products, including HIV products, from internet pharmacies in other countries at substantial discounts. Such cross-border sales could adversely affect our revenues.

In some countries, we may be required to grant compulsory licenses for our products or face generic competition for our products.

In a number of developing countries, government officials and other groups have suggested that pharmaceutical companies should make drugs for HIV infection available at a low cost. Alternatively, governments in those countries could require that we grant compulsory licenses to allow competitors to manufacture and sell their own versions of our products, thereby reducing our product sales. For example, in the past, certain offices of the government of Brazil have expressed concern over the affordability of our HIV products and declared that they were considering issuing compulsory licenses to permit the manufacture of otherwise patented products for HIV infection, including Viread. As a result of discussions with the Brazilian government Gilead reached agreement with the Brazilian Health Ministry in May 2006 to reduce the price of Viread in Brazil by approximately 50%. In addition, concerns over the cost and availability of Tamiflu as fear grows about a potential avian flu pandemic have generated international discussions over potential compulsory licensing of our Tamiflu patents. For example, we are aware that the Canadian government is considering measures that would allow Canadian manufacturers to manufacture and sell the active ingredient in Tamiflu in Canada and certain other countries. Furthermore, Roche may issue voluntary licenses to permit third-party manufacturing of Tamiflu. For example, Roche has granted a sublicense to Shanghai Pharmaceutical (Group) Co., Ltd. for China and a sublicense to India’s Hetero Drugs Limited for India and certain developing countries. Should one or more compulsory licenses be issued permitting generic manufacturing to override Gilead’s Tamiflu patents, or should Roche issue additional voluntary licenses to permit third-party manufacturing of Tamiflu, those developments could reduce royalties we receive from Roche’s sales of Tamiflu. Certain countries do not permit enforcement of our patents, and manufacturers are able to sell generic versions of our products in those countries. Compulsory licenses or sales of generic versions of our products could significantly reduce our sales and adversely affect our results of operations, particularly if generic versions of our products are imported into territories where we have existing commercial sales.

 

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Our existing products are subject to reimbursement from government agencies and other third parties. Pharmaceutical pricing and reimbursement pressures may reduce profitability.

Successful commercialization of our products depends, in part, on the availability of governmental and third-party payor reimbursement for the cost of such products and related treatments. Government health administration authorities, private health insurers and other organizations generally provide reimbursement. Government authorities and third-party payors increasingly are challenging the price of medical products and services, particularly for innovative new products and therapies. This has resulted in lower average sales prices. For example, a majority of our sales of AmBisome and Vistide, and a majority of our sales of Truvada, Viread, Atripla and Hepsera, are subject to reimbursement by government agencies, resulting in significant discounts from list price and rebate obligations. Our business may be adversely affected by an increase in U.S. or international pricing pressures. These pressures can arise from rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement policies and pricing in general.

In Europe, the success of Truvada, Viread, Emtriva, Ambisome, Hepsera and Tamiflu will also depend largely on obtaining and maintaining government reimbursement because in many European countries, including the United Kingdom and France, patients are unlikely to use prescription drugs that are not reimbursed by their governments. In addition, negotiating prices with governmental authorities can delay commercialization by twelve months or more. We also expect that the success of our products in development, particularly in Europe, will depend on the ability to obtain reimbursement. Even if reimbursement is available, reimbursement policies may adversely affect our ability to sell our products on a profitable basis. For example, in Europe as in many international markets, governments control the prices of prescription pharmaceuticals and expect prices of prescription pharmaceuticals to decline over the life of the product or as volumes increase. As new drugs come to market, we may face significant price decreases for our products across much of Europe. We believe that this will continue into the foreseeable future as governments struggle with escalating health care spending. As a result of these pricing practices, it may become difficult to maintain our historic levels of profitability or to achieve expected rates of growth.

Our results of operations could be adversely affected by recent and future health care reforms.

Legislative and regulatory changes to government prescription drug procurement and reimbursement programs occur relatively frequently in the United States and foreign jurisdictions. Recently, there have been significant changes to the federal Medicare system in the United States that could impact the pricing of our products. The new Medicare Part D benefit for prescription drugs began on January 1, 2006. Many factors influence the possible impact of this program on us. For example, not all drugs in a class may be covered and the amount the Medicare program pays for our products may be lowered if legislation is introduced and passed into law that mandates discounts or allows the government to negotiate discounts. In addition, some Medicare patients under this new program are required to pay co-insurance, which may influence which products are recommended by physicians and selected by patients. Participation in Medicare Part D is mandatory for those who are dually eligible for state Medicaid and federal Medicare programs. As a result, changes to federal or state Medicaid drug payment regulations or other foreign or domestic healthcare reforms could lower payment for our products or introduce new discounts. Such changes could adversely affect our results of operations.

We may face significant liability resulting from our products that may not be covered by insurance and successful claims could materially reduce our earnings.

The testing, manufacturing, marketing and use of our commercial products, as well as products in development, involve substantial risk of product liability claims. These claims may be made directly by consumers, healthcare providers, pharmaceutical companies or others. Our product liability insurance may not cover a successful product liability claim against us and we could be required to pay amounts beyond that provided by our insurance, either of which could impair our financial condition and our ability to clinically test and to market our products.

Expensive litigation may reduce our earnings.

We are named as a defendant in lawsuits regarding the use of average wholesale price and reimbursement rates under Medicaid. In addition, the plaintiffs have appealed the dismissal of a class action lawsuit brought against us alleging violations of federal securities laws. Adverse results from these lawsuits, or any others brought against us could result in material damages that could significantly reduce our earnings and cash flows.

 

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Changes in our income tax rate could reduce our earnings.

Various factors may have favorable or unfavorable effects on our income tax rate. These factors include, but are not limited to, interpretations of existing tax laws, our adoption of SFAS 123R relating to the accounting for stock options and other share-based payments, changes in tax laws and rates, mergers and acquisitions, future levels of R&D spending, changes in accounting standards, future levels of capital expenditures, changes in the mix of earnings in the various tax jurisdictions in which we operate and changes in overall levels of pre-tax earnings. The impact on our income tax provision resulting from the above-mentioned factors may be significant and could have a negative impact on our net income or loss.

Recently adopted changes in accounting for stock options will significantly reduce our earnings.

We adopted SFAS 123R on January 1, 2006, under which we are required to record additional compensation expense related to stock options and other share-based payments in 2006 and beyond. This new standard has a significant negative impact on our reported results of operations compared to the results we have reported under prior accounting standards on stock options and other share-based payments.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

None.

ITEM 5. OTHER INFORMATION

On August 18, 2006, we executed a Sixth Amendment Agreement with the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic and K. U. Leuven Research and Development. This amendment sets forth Gilead’s royalty obligations for the sale of tenofovir in upper and lower middle income and Gilead Access Program countries. In upper and lower middle income countries, Gilead will pay a royalty equal to three percent of the gross amount received by Gilead from any third party in consideration for the sale of tenofovir. For sales of tenofovir in the access countries, pursuant to licenses granted by Gilead to 11 companies in India, Gilead will pay a royalty equal to 20 percent of the gross amount received from any such Indian company in consideration for the sale of tenofovir.

On October 1, 2006, we entered into an Agreement and Plan of Merger pursuant to which we plan to acquire all of the outstanding common stock of Myogen, Inc. (Myogen) for total consideration, including the assumption by Gilead of all outstanding Myogen stock options, of approximately $2.5 billion. Myogen is a publicly held biopharmaceutical company based in Westminster, Colorado, focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. We expect this transaction to close in the fourth quarter of 2006, subject to the satisfaction of certain closing conditions. More information about this transaction can be found in our Current Report on Form 8-K filed with the Securities and Exchange Commission (SEC) on October 5, 2006 and our Schedule TO filed with the SEC on October 16, 2006.

 

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ITEM 6. EXHIBITS

 

3.1 (1)   Restated Certificate of Incorporation of the Registrant, as amended
3.2 (2)   Bylaws of the Registrant, as amended and restated March 30, 1999
3.3 (3)   Certificate of Designation of Series A Junior Participating Preferred Stock of the Registrant, as amended
3.4 (4)   Certificate of Amendment to Restated Certificate of Incorporation of the Registrant
3.5 (4)   Certificate of Amendment to Certificate of Designation of the Registrant
4.1   Reference is made to Exhibit 3.1, Exhibit 3.2, Exhibit 3.3, Exhibit 3.4 and Exhibit 3.5
4.2 (5)   Amended and Restated Rights Agreement dated as of October 21, 1999 between the Registrant and ChaseMellon Shareholder Services, LLC
4.6 (6)   First Amendment to Amended and Restated Rights Agreement dated as of October 29, 2003 between the Registrant and Mellon Investor Services, LLC (formerly known as ChaseMellon Shareholder Services, LLC)
4.7 (7)   Second Amendment to Amended and Restated Rights Agreement dated as of May 11, 2006 between the Registrant and Mellon Investor Services, LLC
10.1 (8)
  Agreement and Plan of Merger dated as of October 1, 2006 by and among Gilead Sciences, Inc., Mustang Merger Sub, Inc. and Myogen, Inc.
10.2*   Amended and Restated Collaboration Agreement dated as of September 28, 2006 by and among Gilead Sciences, Inc., Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC
10.3   Sixth Amendment Agreement, dated August 18, 2006 between Registrant and IOCB/REGA
10.4   Form of Restricted Stock Award Agreement
10.5*   Development and License Agreement, dated September 27, 1996 by and between Gilead Sciences, Inc. and F. Hoffmann-LA Roche Ltd. and Hoffmann-LA Roche Inc.
10.6   Agreement and Plan of Merger dated as of April 12, 2006 by and among Gilead Sciences, Inc., Gryphon Acquisition Sub, Inc., Corus Pharma, Inc. and Rodney A. Ferguson, Ph.D, as Chairman of and on behalf of the Stockholder Representative Committee
31.1   Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2   Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32**   Certification of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)

(1) Filed as an exhibit to Registrant’s Registration Statement on Form S-8 (File No. 333-117420), filed on July 19, 2004, and incorporated herein by reference.
(2) Filed as an exhibit to Registrant’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference.
(3) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed with the SEC on November 21, 1994 and incorporated herein by reference.
(4) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed with the SEC on May 11, 2006 and incorporated herein by reference.
(5) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on October 22, 1999, and incorporated herein by reference.
(6) Filed as an exhibit to the Registrant’s Current Report on Form 8-K filed on October 31, 2003, and incorporated herein by reference.
(7) Filed as an exhibit to Registrant’s Registration Statement on Form S-8 (File No. 333-135412), filed on June 28, 2006, and incorporated herein by reference.
(8) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on October 5, 2006, and incorporated herein by reference.
* Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the SEC without the Mark pursuant to the Registrant’s Application Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
** This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 

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SIGNATURES

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.

 

 

GILEAD SCIENCES, INC.

(Registrant)

Date: November 3, 2006  

/s/ John C. Martin

 

John C. Martin

President and Chief Executive Officer

Date: November 3, 2006  

/s/ John F. Milligan

 

John F. Milligan, Ph.D.

Executive Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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Table of Contents

Exhibit Index

(a) Exhibits

 

3.1 (1)   Restated Certificate of Incorporation of the Registrant, as amended
3.2 (2)   Bylaws of the Registrant, as amended and restated March 30, 1999
3.3 (3)   Certificate of Designation of Series A Junior Participating Preferred Stock of the Registrant, as amended
3.4 (4)   Certificate of Amendment to Restated Certificate of Incorporation of the Registrant
3.5 (4)   Certificate of Amendment to Certificate of Designation of the Registrant
4.1   Reference is made to Exhibit 3.1, Exhibit 3.2, Exhibit 3.3, Exhibit 3.4 and Exhibit 3.5
4.2 (5)   Amended and Restated Rights Agreement dated as of October 21, 1999 between the Registrant and ChaseMellon Shareholder Services, LLC
4.6 (6)   First Amendment to Amended and Restated Rights Agreement dated as of October 29, 2003 between the Registrant and Mellon Investor Services, LLC (formerly known as ChaseMellon Shareholder Services, LLC)
4.7 (7)   Second Amendment to Amended and Restated Rights Agreement dated as of May 11, 2006 between the Registrant and Mellon Investor Services, LLC
10.1 (8)
  Agreement and Plan of Merger dated as of October 1, 2006 by and among Gilead Sciences, Inc., Mustang Merger Sub, Inc. and Myogen, Inc.
10.2*   Amended and Restated Collaboration Agreement dated as of September 28, 2006 by and among Gilead Sciences Inc., Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC
10.3   Sixth Amendment Agreement, dated August 18, 2006 between Registrant and IOCB/REGA
10.4   Form of Restricted Stock Award Agreement
10.5*   Development and License Agreement, dated September 27, 1996 by and between Gilead Sciences, Inc. and F. Hoffmann-LA Roche Ltd. and Hoffmann-LA Roche Inc.
10.6   Agreement and Plan of Merger dated as of April 12, 2006 by and among Gilead Sciences, Inc., Gryphon Acquisition Sub, Inc., Corus Pharma, Inc. and Rodney A. Ferguson, Ph.D, as Chairman of and on behalf of the Stockholder Representative Committee
31.1   Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2   Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32**   Certification of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)

(1) Filed as an exhibit to Registrant’s Registration Statement on Form S-8 (File No. 333-117420), filed on July 19, 2004, and incorporated herein by reference.
(2) Filed as an exhibit to Registrant’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference.
(3) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed with the SEC on November 21, 1994 and incorporated herein by reference.
(4) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed with the SEC on May 11, 2006 and incorporated herein by reference.
(5) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on October 22, 1999, and incorporated herein by reference.
(6) Filed as an exhibit to the Registrant’s Current Report on Form 8-K filed on October 31, 2003, and incorporated herein by reference.
(7) Filed as an exhibit to Registrant’s Registration Statement on Form S-8 (File No. 333-135412), filed on June 28, 2006, and incorporated herein by reference.
* Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the SEC without the Mark pursuant to the Registrant’s Application Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
(8) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on October 5, 2006, and incorporated herein by reference.
** This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 

41

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

E XHIBIT 10.2

AMENDED AND RESTATED

COLLABORATION AGREEMENT

 

by and among

 

GILEAD SCIENCES, INC.,

GILEAD HOLDINGS, LLC,

 

BRISTOL-MYERS SQUIBB COMPANY,

E.R. SQUIBB & SONS, L.L.C.,

and

BRISTOL-MYERS SQUIBB & GILEAD SCIENCES, LLC

Dated as of September 28, 2006


TABLE OF CONTENTS

 

SECTION 1.

          DEFINITIONS    2

SECTION 2.

          COLLABORATION MANAGEMENT    23
  2.1     General    23
  2.2     Role of the Joint Executive Committee    24
  2.3     Joint Development Committee    25
  2.4     Joint Commercialization Committee    26
  2.5     Joint Canadian Operating Committee    27
  2.6     Joint Finance Committee    29
  2.7     Procedural Rules of the Operating Committees    30
  2.8     Alliance Managers    32
  2.9     Dispute Resolution    32
  2.10   Collaboration Principles    34
  2.11   Commercialization Budget/Plan Deadlocks    35
  2.12   Expenses    36

SECTION 3.

          DEVELOPMENT ACTIVITIES    36
  3.1     General    36
  3.2     Clinical Development    36
  3.3     Formulation and CMC Data    38
  3.4     Regulatory Matters    38
  3.5     Performance; Subcontracting    40
  3.6     Records    40
  3.7     Updates to Development Plan and Development Budget    41
  3.8     Development Expenses    41
  3.9     Reports    42
  3.10   New Products    42
  3.11   Publication    43
  3.12   Certain Inspections    44
  3.13   Medical Affairs and Medical Communications    44

SECTION 4.

          MANUFACTURING AND SUPPLY    45
  4.1     Clinical Supply    45
  4.2     Commercial Supply    45

SECTION 5.

          COMMERCIALIZATION ACTIVITIES    46
  5.1     Co-Promotion Obligations    46
  5.2     Distribution Obligations    48
  5.3     Pricing of Combination Product    50
  5.4     National Accounts in the United States    54
  5.5     Performance; Subcontracting    55
  5.6     Conflict Avoidance    55
  5.7     Marketing Materials    55
  5.8     Development and Use of Trademarks    57
  5.9     Insurance    57
  5.10   Records    57
  5.11   Commercialization Plans and Budgets    58

 

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  5.12   Commercialization Expenses    59
  5.13   Reports    60

SECTION 6.

          LICENSE GRANTS    61
  6.1     Technology Licenses by Member Parties to the JV    61
  6.2     Licenses and Sublicenses by the JV to Member Parties    61
  6.3     Licenses and Rights of Reference Between Member Parties    64
  6.4     Rights of Reference to and from the JV and Related Matters    65
  6.5     Other Sublicenses    66
  6.6     Trademark Licenses by Member Parties to the JV    66
  6.7     Trademark License by the JV to Gilead    67
  6.8     Retained Rights    68
  6.9     Combination Product Sales for Outside the United States, Canada and Europe    68
6.10   Combination Product Sales for Europe    68
6.11   EFV License Agreement    68
6.12   JV Obligations as Sublicensee    69

SECTION 7.

          PAYMENTS AND THIRD PARTY ROYALTIES    69
  7.1     Payments to Member Parties    69
  7.2     Royalty Payments to Third Parties    73
  7.3     Authorized Expenses; Mode and Timing of Payment    73
  7.4     Taxes    74
  7.5     Restructuring    74

SECTION 8.

          FINANCIAL RECORDS    74
  8.1     Financial Records    74
  8.2     Audit of Records    75
  8.3     Certain Reports    75

SECTION 9.

          ADVERSE EVENT AND OTHER INFORMATION EXCHANGE    75
  9.1     Pharmacovigilance    75
  9.2     Material Communications    76

SECTION 10.

          PRODUCT RECALL    76
10.1     Notification and Recall    77
10.2     Recall Expenses    77

SECTION 11.

          INTELLECTUAL PROPERTY RIGHTS    77
11.1     Ownership of Intellectual Property    77
11.2     Prosecution of Patents    78
11.3     Enforcement of Patents    79
11.4     Infringement of Third Party Rights    80
11.5     Trademarks    81

SECTION 12.

          CONFIDENTIALITY    82
12.1     Treatment of Confidential Information    82
12.2     Permitted Disclosure    82
12.3     Confidential Information.    84
12.4     Use of Name    85
12.5     Publicity; Terms of Agreement    85
12.6     Notification    85
12.7     Permitted Uses    86
12.8     Remedies    86

 

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SECTION 13.

           WARRANTIES; INDEMNITIES    86
13.1      Representations, Warranties and Covenants    86
13.2      Additional Representations, Warranties and Covenants of BMS    87
13.3      Additional Representations, Warranties and Covenants of Gilead    89
13.4      Disclaimer    90
13.5      Indemnification by the JV    90
13.6      Indemnification by the Member Parties in General    91
13.7      Indemnification for Certain Product Liability Related Matters    92
13.8      Indemnification Procedure    93
13.9      Limitation on Damages    94
13.10    Ancillary Agreements    94
13.11    Employees    95

SECTION 14.

           TERM AND TERMINATION    95
14.1      Term    95
14.2      Certain Litigation    95
14.3      Termination with respect to Canada    95
14.4      Material Default    95
14.5      Termination Upon Generic Launch in the United States    97
14.6      Consequences of Termination    97
14.7      Rights in Bankruptcy    100
14.8      Accrued Rights; Surviving Obligations    100

SECTION 15.

           GENERAL PROVISIONS    101
15.1      Force Majeure    101
15.2      Notice    101
15.3      Further Assurances    102
15.4      Successors and Assigns    102
15.5      Governing Law    103
15.6      Arbitration    103
15.7      Waiver    105
15.8      Severability    105
15.9      Counterparts    105
15.10    Construction    105
15.11    Status of the Parties    106
15.12    Standstill    106
15.13    Nonsolicitation of Employees    107
15.14    Entire Agreement    107
15.15    Consent to Jurisdiction    108
15.16    Third Parties    108

 

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Annexes:

Annex A – Initial Committee Members and Alliance Managers

Annex B – Development Plan and Development Budget as of Effective Date

Annex C – U.S. Commercialization Plan and U.S. Commercialization Budget as of Effective Date

Annex D – BMS Patents in the U.S.

Annex E – Gilead Patents in the U.S.

Annex F – Gilead Licensed Trademarks

Annex G – BMS Licensed Trademarks

Annex H – Quarterly Detail Report

Annex I – Manner of Calculation of Net Selling Price

Annex J – Calculation of Cost of Goods

Annex K – Calculation of Transfer Price

Annex L – Joint Press Release Following Effective Date

Annex M – Certain Financial Data

Annex N – Data to be Provided to Independent Accounting Expert Pursuant to Section 7.1

Annex O – JV Obligations as Sublicensee

Annex P1 – Key Terms of Services Agreement

Annex P2 – Key Terms of Canada Distribution and Supply Agreement; Structure Schematic

Annex Q1 – [ * ] Pricing [ * ]

Annex Q2 – [ * ] Pricing [ * ]

Annex R – List of Countries Comprising the Developing World

Annex S – BMS Patents in Canada

Annex T – Gilead Patents in Canada

Annex U – Canadian Commercialization Plan and Canadian Commercialization Budget as of Amended Effective Date

Annex V – Development Plan and Development Budget for Canada

Annex W – Joint Press Release Following Amended Effective Date

 

-iv-


THIS AMENDED AND RESTATED COLLABORATION AGREEMENT is made as of September 28, 2006 (the “Amended Effective Date”), by and among Gilead Sciences, Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404 (“Gilead Parent”), Gilead Holdings, LLC, a Delaware limited liability company and wholly-owned subsidiary of Gilead Parent (“Gilead Sub” and, collectively with Gilead Parent, “Gilead”), Bristol-Myers Squibb Company, a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 345 Park Avenue, New York, NY 10154 (“BMS Parent”), E.R. Squibb & Sons, L.L.C., a Delaware limited liability company and wholly-owned subsidiary of BMS Parent (“BMS Sub” and, collectively with BMS Parent, “BMS”), and Bristol-Myers Squibb & Gilead Sciences, LLC, a limited liability company organized and existing under the laws of the State of Delaware and having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404 (the “JV”) (Gilead, BMS and the JV, collectively, the “Parties” and each a “Party”).

RECITALS

WHEREAS, Gilead has developed and is marketing a proprietary nucleotide reverse transcriptase inhibitor, Viread ® (known under the generic name of tenofovir disoproxil fumarate (“TDF”)), a proprietary nucleoside reverse transcriptase inhibitor, Emtriva ® (known under the generic name of emtricitabine (“FTC”)), and a fixed-dose co-formulated product containing TDF and FTC as its only active pharmaceutical ingredients, Truvada ® , for the treatment of HIV infection in adults;

WHEREAS, BMS has developed and is marketing a proprietary non-nucleoside reverse transcriptase inhibitor, Sustiva ® (known under the generic name of efavirenz (“EFV”)) for the treatment of HIV infection in adults;

WHEREAS, Gilead and BMS, in order to develop and commercialize in the United States, through a joint venture entity, a fixed-dose, co-formulated combination product containing TDF, FTC and EFV as its only active pharmaceutical ingredients, entered into a Collaboration Agreement dated as of December 17, 2004 (the “Collaboration Agreement”);

WHEREAS, for that purpose, Gilead and BMS formed such a joint venture pursuant to that certain Operating Agreement entered into as of the Effective Date by and between Gilead Sub and BMS Sub (the “Operating Agreement”);

WHEREAS, the Parties allocated among themselves certain rights and duties relating to the development and commercialization of such a combination product, upon the terms and conditions of the Collaboration Agreement, the Operating Agreement and the Ancillary Agreements (as defined below); and

WHEREAS, pursuant to the BMS Guarantee Agreement and the Gilead Guarantee Agreement (as such terms are defined below), each dated as of the Effective Date, BMS Parent and Gilead Parent have guaranteed, and will continue to guarantee, the performance of all of the obligations of BMS Sub and Gilead Sub, respectively, under this Agreement, the Operating Agreement and all Ancillary Agreements to which the applicable Affiliate (as defined below) is or becomes a party;

 

-1-

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .


WHEREAS, pursuant to the Collaboration Agreement, the JV has launched such a combination product in the United States; and

WHEREAS, the Parties now wish to amend and restate the Collaboration Agreement, as set forth herein, in order to provide for the development and commercialization of such a combination product in Canada as well;

NOW, THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

SECTION 1.

DEFINITIONS

1.1 “Actual BMS Percentage” shall mean, for each Calendar Year, the percentage applicable to BMS for such Calendar Year based on historical data and determined pursuant to Section 7.1(b).

1.2 “Actual Gilead Percentage” shall mean, for each Calendar Year, the percentage applicable to Gilead for such Calendar Year based on historical data and determined pursuant to Section 7.1(b).

1.3 “Actual Percentage” shall mean, with respect to BMS, the Actual BMS Percentage and, with respect to Gilead, the Actual Gilead Percentage.

1.4 “Actual Yield” shall have the meaning set forth in Annex K.

1.5 “Affiliate” of a Person shall mean any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Person. For purposes of this definition only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person; provided , however , that if local law restricts foreign ownership, control shall be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests. For purposes of this Agreement, the Operating Agreement and the Ancillary Agreements, the JV shall not be deemed to be an Affiliate of either Gilead or BMS.

1.6 “Agreement” shall mean the Collaboration Agreement, as amended and restated as of the Amended Effective Date.

1.7 “Alliance Manager” shall have the meaning set forth in Section 2.7(a).

 

-2-

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .


1.8 “Allocated Costs” shall have the meaning set forth in Section 5.12.

1.9 “Amended Effective Date” shall have the meaning set forth in the first paragraph above.

1.10 “AMP” shall have the meaning set forth in Annex Q.

1.11 “Ancillary Agreements” shall mean, collectively, the BMS Supply Agreement, the Gilead Supply Agreement, the Services Agreement and the SDEA.

1.12 [ * ] shall have the meaning set forth in Section 5.1(f).

1.13 “Applicable EFV Territory” shall mean (a) with respect to any BMS Technology licensed to BMS by the EFV Licensor or licensed to the EFV Licensor by BMS, in each case under the EFV License Agreement, the EFV License Agreement Territory, and (b) with respect to all other BMS Technology, worldwide.

1.14 “Applicable Law” shall mean the applicable laws, rules, and regulations, including, without limitation, any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time in the Territory.

1.15 “Approvals” shall mean, collectively, the approvals granted by the Regulatory Authorities for the Manufacture, Marketing, sale and/or use of the Combination Product in the Field in the Territory, including, without limitation, pricing and reimbursement approvals (if any).

1.16 “Approved Marketing Materials” shall have the meaning set forth in Section 5.7(a).

1.17 [ * ]

1.18 [ * ] Representative” shall have the meaning set forth in Section 5.3A(b).

1.19 “Authorized Commercialization Expenses” shall have the meaning set forth in Section 5.12.

1.20 “Authorized Development Expenses” shall have the meaning set forth in Section 3.8.

1.21 “Authorized Expenses” shall mean, collectively, the Authorized Commercialization Expenses, Authorized Development Expenses and Authorized Other Expenses.

1.22 “Authorized Other Expenses” shall mean all JV Expenses expressly stated in this Agreement or the Operating Agreement or any Ancillary Agreement to be Authorized Other Expenses or agreed by the JEC to be Authorized Other Expenses.

 

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1.23 “AWP” shall have the meaning set forth in Annex Q.

1.24 “BMS” shall have the meaning set forth in the first paragraph of this Agreement.

1.25 “BMS Core Improvement” shall mean any Improvement pertaining specifically to BMS Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of Gilead or its Affiliates or the JV in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; provided , however , that BMS Core Improvements shall not include any Dual Improvements.

1.26 “BMS Core Technology” shall mean all BMS proprietary technologies relating specifically to the Exploitation of EFV.

1.27 “BMS Guarantee Agreement” shall mean the guarantee agreement executed by BMS Parent in favor of Gilead and the JV, dated as of the Effective Date, as such agreement may be amended from time to time.

1.28 “BMS Indemnified Party” shall mean BMS Sub, BMS Parent and any of their Affiliates, officers, directors and employees.

1.29 “BMS Inventions” shall mean any Information and Inventions (whether or not patentable; and Improvements thereto, including Gilead Core Improvements to the extent owned by BMS) conceived, discovered, developed or otherwise made, as necessary to establish authorship or inventorship under United States or Canadian copyright or patent law, as the case may be, solely (or, in the case of Gilead Core Improvements, solely or jointly) by or on behalf of BMS or its Affiliates, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials, but excluding any Joint Inventions.

1.30 “BMS Know-How” shall mean any and all Information and Inventions under the Control of BMS or its Affiliates as of the Effective Date or at any time during the term of this Agreement that are necessary or reasonably useful for the Exploitation of the Combination Product and are not generally known, but excluding any and all (a) such Information and Inventions to the extent claimed by the BMS Patents and (b) Joint Know-How.

1.31 “BMS Licensed Trademarks” shall have the meaning set forth in Section 6.6(b).

1.32 “BMS Parent” shall have the meaning set forth in the first paragraph of this Agreement.

1.33 “BMS Patents” shall mean all of the Patents that BMS or its Affiliates Control as of the Effective Date or at any time during the term of this Agreement that would, in

 

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the absence of the license granted by BMS in Section 6.1(b) and assuming that the EFV active pharmaceutical ingredient therein was not purchased from BMS, be infringed by the Exploitation of the Combination Product by the JV in any country in the world. A list of the BMS Patents in the United States as of the Effective Date is attached hereto as Annex D, and a list of the BMS Patents in Canada as of the Amended Effective Date is attached hereto as Annex S.

1.34 “BMS Regulatory Documentation” shall mean all Regulatory Documentation applicable to Sustiva (or EFV) but not Sustiva (or EFV) in co-formulation with Viread (or TDF), Emtriva (or FTC), or Truvada (or TDF and FTC), that is or was developed by or on behalf of BMS or any of its Affiliates or sublicensees prior to the Effective Date or during the term of this Agreement.

1.35 “BMS Sub” shall have the meaning set forth in the first paragraph of this Agreement.

1.36 “BMS Supply Agreement” shall mean the supply agreement entered into between BMS Sub and the JV as of the Effective Date, as such agreement may be amended from time to time.

1.37 “BMS Technology” shall mean, collectively, the BMS Know-How and the BMS Patents.

1.38 “BMS Transfer Price” shall have the meaning set forth in Section 7.1(a).

1.39 “Breaching Member Party” shall have the meaning set forth in Section 14.4(a).

1.40 “Business Day” shall mean a day that is not a Saturday, Sunday or day on which banking institutions in New York, New York or San Francisco, California are required by law to remain closed.

1.41 [ * ] Representative” shall have the meaning set forth in Section 5.3A(b).

1.42 “Calendar Quarter” shall mean a period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.

1.43 “Calendar Year” shall mean a period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31.

1.44 “Canada” shall mean Canada, its provinces and territories.

1.45 “Canada Distribution and Supply Agreement” shall have the meaning set forth in Section 5.2.

 

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1.46 “Canadian Act” shall mean the Food and Drugs Act (Canada), as amended.

1.47 “Canadian Commercialization Budget” shall have the meaning set forth in Section 5.11(b). The initial Canadian Commercialization Budget is attached hereto as Annex U.

1.48 “Canadian Commercialization Plan” shall mean the plan for Marketing and otherwise commercializing the Combination Product in Canada as described in Section 5.11(b), as updated from time to time pursuant to Section 5.11(c). The initial Canadian Commercialization Plan is attached hereto as Annex U.

1.49 “Canadian Pricing Information” shall have the meaning set forth in Section 5.3B(f).

1.50 [ * ]

1.51 “Change of Control” shall mean, with respect to a Person, any of the following transactions with a Third Party (a “Third Party Acquirer”): (a) a merger or consolidation of such Person with the Third Party Acquirer which results in the holders of the voting securities of such Person outstanding immediately prior thereto (other than the Third Party Acquirer, its “affiliates” and “associates” (as such terms are used in the Exchange Act)) ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity (or, if applicable, its parent company) immediately after such merger or consolidation; (b) the sale to the Third Party Acquirer of all or substantially all of the business of such Person to which this Agreement relates (whether by merger, consolidation, sale of stock, sale of assets or other similar transaction); or (c) the Third Party Acquirer (which shall not be any trustee or other fiduciary holding securities under an employee benefit plan of such Person, or any corporation owned directly or indirectly by the stockholders of such Person, in substantially the same proportion as their ownership of stock of such Person), together with any of the Third Party Acquirer’s “affiliates” or “associates”, as such terms are used in the Exchange Act, becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Person or by contract or otherwise having the right to control the Board of Directors or equivalent governing body of such Person or the ability to cause the direction of management of such Person.

1.52 “Clinical Data” shall mean any and all data (together with the results of analysis thereof) derived or generated from any clinical trial of a pharmaceutical product or from testing or analysis of subjects or samples from such a clinical trial (e.g. in vitro testing of tissue samples from subjects enrolled in such a clinical trial), in each case where such clinical trial involves either or both of (i) any Single Agent Product or Double Agent Product, whether alone or in combination with any other product, and (ii) the Combination Product, whether alone or in combination with any other product.

1.53 “Clinical Trial Registry” shall have the meaning set forth in Section 3.11(b).

 

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1.54 “Clinical Trial Results Database” shall have the meaning set forth in Section 3.11(b).

1.55 “CMC Data” shall mean any and all information contained in, as well as data supporting, the “Chemistry, Manufacturing and Control” and facilities sections (or sections corresponding thereto) of an NDA or NDS, including, without limitation, any drug master files referenced in the NDA or NDS.

1.56 “Co-Funded Clinical Trial” shall have the meaning set forth in Section 3.2(b).

1.57 “Collaboration Agreement” shall have the meaning set forth in the recitals to this Agreement.

1.58 “Collaboration Principles” shall have the meaning set forth in Section 2.10.

1.59 “Combination Product” shall mean the fixed-dose co-formulated product developed pursuant to this Agreement containing, as its only active pharmaceutical ingredients per single daily dose, 300 mg TDF, 200 mg FTC and 600 mg EFV.

1.60 “Combination Product Regulatory Documentation” shall mean all Regulatory Documentation applicable to the Combination Product that is developed by or on behalf of any Party pursuant to, and during the term of, this Agreement, but excluding all BMS Regulatory Documentation and all Gilead Regulatory Documentation.

1.61 “Combination Product Trademarks” shall mean the trademark or trademarks selected by the JCC for the Combination Product, all packaging designs and other trade dress used in connection with the Combination Product, other Trademarks relating thereto and any registrations thereof or any pending applications relating thereto. For the avoidance of doubt, the following shall not be considered Combination Product Trademarks: (a) BMS Licensed Trademarks, (b) Gilead Licensed Trademarks and (c) the names, logos and other Trademarks of the Member Parties.

1.62 “Commercialization Activities” shall mean, with respect to Canada, Marketing and other activities for the commercialization of the Combination Product including those set forth in the Canadian Commercialization Plan and any other of the following conducted for the Combination Product in Canada: execution of product positioning, preparation of promotional and marketing materials, market research and advertising activities, Promotion, advocacy, government and other public relations activities, [ * ] and with respect to the United States, Marketing and other activities for the commercialization of the Combination Product including those set forth in the U.S. Commercialization Plan and any other of the following conducted for the Combination Product in the United States: execution of product positioning, preparation of promotional and marketing materials, market research and advertising activities, Promotion, advocacy, national accounts, government relations activities, pricing, reimbursement and patient assistance programs.

 

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1.63 “Commercialization Budgets” shall mean the Canadian Commercialization Budget and the U.S. Commercialization Budget.

1.64 “Commercialization Budget Deadlock” shall have the meaning set forth in Section 2.11(d).

1.65 “Commercialization Committee” shall mean the JCC or JCOC, as applicable.

1.66 “Commercialization Plans” shall mean the Canadian Commercialization Plan and the U.S. Commercialization Plan.

1.67 “Commercialization Plan Deadlock” shall have the meaning set forth in Section 2.11(d).

1.68 “Commercially Reasonable Efforts” shall mean, with respect to (a) the Development Activities that a Member Party is required to perform with respect to the Combination Product pursuant to the Development Plan, or (b) the Commercialization Activities that a Member Party is required to perform with respect to the Combination Product pursuant to a Commercialization Plan, as the case may be, the level of effort that would generally be used by a Member Party to conduct such development or commercialization activities in a manner consistent with the minimum level of expenditure contemplated for such activities by the Development Budget or a Commercialization Budget, as the case may be, for a product or compound owned by it or to which it has rights, which is of comparable market potential, profit potential or strategic value to such Member Party and is at a similar stage in its development or product life, taking into account, without limitation, issues of safety and efficacy, product profile, the proprietary position, the then-current competitive environment for such product or compound (and any individual agent comprising part of such product or compound), the likely timing of the product’s or compound’s (and any such individual agent’s) entry into the market, the then-current market penetration, the return on investment potential of such product (and any individual agent comprising part of such product), the regulatory environment and status of the product (and any individual agent comprising part of such product), and other relevant scientific, technical and commercial factors, in each case as measured by the facts and circumstances at the time such efforts are due. Such determination shall be made on a country-by-country basis.

1.69 “Commercial Record Request” shall have the meaning set forth in Section 5.10(b).

1.70 “Competing Product” shall mean (a) in the case of Gilead as the assigning Member Party, a [ * ] and (b) in the case of BMS as the assigning Member Party, a [ * ]

1.71 “Confidential Information” shall have the meaning set forth in Section 12.3(a).

 

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1.72 “Continuing Member Party” shall mean a Member Party as so designated pursuant to Section 14.5.

1.73 “Control” or “Controlled” shall mean, with respect to any item of Information and Inventions, Patents or other intellectual property rights, the right, whether by ownership, license or otherwise, to grant a license, sublicense or other right to or under such item, Patent or right as provided for in this Agreement without violating the terms of any agreement or other binding arrangement with any Third Party. For purposes of this Section 1.73, the consent referred to in Section 6.12 shall be deemed to have been obtained as of the Effective Date.

1.74 “Core Technology” shall mean the BMS Core Technology or the Gilead Core Technology, as the case may be.

1.75 “Cost Allocation Proposal” shall have the meaning set forth in Section 5.12.

1.76 “Cost of Goods” shall have the meaning set forth in Annex J hereto.

1.77 “CTA” shall mean a Clinical Trial Application to be filed in Canada with the HPFB in accordance with Applicable Law.

1.78 “Court” shall have the meaning set forth in Section 15.15.

1.79 “Detail” shall mean an in-person presentation to a health care provider specializing in treatment of HIV infection or AIDS, and who has prescribing authority, by a sales representative who is fully equipped with knowledge of, and (subject to Section 5.7) Approved Marketing Materials and product labels and inserts with respect to, the Combination Product, in which the characteristics of the Combination Product are described by such sales representative in a fair and balanced manner consistent with the requirements of Applicable Law and of this Agreement, and in a manner that is customary in the industry for the purpose of promoting a prescription pharmaceutical product, but without regard to the position of the presentation within a call to the health care provider. For the avoidance of doubt, a promotional material drop or product reminder shall not constitute a Detail. When used as a verb, to “Detail” shall mean to engage in a Detail.

1.80 “Detail Equivalent Amount” shall mean, for the 2005 Calendar Year and the 2006 Calendar Year, [ * ], and for each successive Calendar Year thereafter, such amount as adjusted by the [ * ] for each such Calendar Year.

1.81 “Developing World” shall mean the territory comprising the countries listed in Annex R and any additional countries outside the Territory and Europe that Gilead includes in its Gilead Access Program, as indicated at the website for the program, www.gileadaccess.org .

 

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1.82 “Development Activities” shall mean the activities set forth in the Development Plan, as updated from time to time pursuant to Section 3.7 and, only with respect to periods prior to the Effective Date, activities pursuant to the MTTA.

1.83 “Development Budget” shall mean the budget with respect to any expenses relating to Development Activities for the Combination Product that are chargeable to the JV, as updated from time to time pursuant to Section 3.7. The Development Budget as of the Effective Date is attached hereto as Annex B, and as of the Amended Effective Date shall include, with respect to Canada, the budget attached hereto as Annex V.

1.84 “Development Plan” shall mean the plan for the regulatory, clinical, formulation, Manufacturing Process and CMC Data development activities to be conducted for the Combination Product, including any Phase IV clinical studies and medical information and medical education programs, as updated from time to time pursuant to Section 3.7. The Development Plan as of the Effective Date is attached hereto as Annex B, and as of the Amended Effective Date shall include, with respect to Canada, the plan attached hereto as Annex V.

1.85 “Development Record Request” shall have the meaning set forth in Section 3.6(b).

1.86 “Disclosing Party” shall have the meaning set forth in Section 12.1.

1.87 [ * ] shall have the meaning set forth in Annex Q1.

1.88 “Double Agent Product” shall mean Truvada, the co-formulated product developed by Gilead containing, as its only active pharmaceutical ingredients, TDF and FTC.

1.89 “Dual Improvement” shall mean an Improvement that constitutes both an Improvement pertaining specifically to the Gilead Core Technology and an Improvement pertaining specifically to the BMS Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of BMS or its Affiliates, Gilead or its Affiliates, the JV or jointly any combination of them, in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials. Any Dual Improvement shall constitute a Joint Invention.

1.90 “Effective Date” shall mean the effective date of the Collaboration Agreement, which is December 17, 2004.

1.91 “EFV” shall have the meaning set forth in the recitals to this Agreement.

1.92 “EFV License Agreement” shall mean that certain license agreement, dated as of September 1, 1994, as amended, between the EFV Licensor and E.R. Squibb & Sons, L.L.C., as successor in interest to DuPont Pharmaceuticals Company (formerly named The DuPont Merck Pharmaceutical Company).

 

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1.93 “EFV License Agreement Territory” shall mean BMS’ territory under the EFV License Agreement, which, as of the Effective Date, consists of the United States (including its territories and possessions), Canada, France (continental area), Germany, Italy, Spain, United Kingdom and the Republic of Ireland, provided , however , that (a) should the EFV License Agreement be amended to expand BMS’ territory, then EFV License Agreement Territory shall forthwith mean BMS’ territory as so expanded; and (b) should the EFV License Agreement be terminated as a result of BMS’ acquisition of all the rights of the EFV Licensor thereunder, then EFV License Agreement Territory shall forthwith mean all countries in the world.

1.94 “EFV Licensor” shall mean, collectively, Merck & Co., Inc., a New Jersey corporation, and Merck and Company Incorporated, a Delaware corporation, and their respective successors in interest.

1.95 “Estimated Net Selling Price” shall have the meaning set forth in Section 7.1(c)(ii).

1.96 “Europe” shall mean all countries comprising the European Union as it may be constituted from time to time.

1.97 “Exchange Act” shall have the meaning set forth in Section 15.12(b).

1.98 “Exploitation” shall mean the making, having made, importation, use, sale, offering for sale or disposition of a product or process, including, without limitation, the research, development, registration, modification, enhancement, Improvement, Manufacturing, storage, formulation, optimization, import, export, transport, distribution, promotion or Marketing of a product or process. When used as a verb, “Exploit” shall mean to engage in any of the foregoing activities.

1.99 “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto.

1.100 “Field” shall mean the treatment of HIV infection in adult humans.

1.101 “Field Force” shall mean sales representatives, and regional or other subnational managers of the foregoing.

1.102 “Final Invoice Date” shall have the meaning set forth in Section 7.3(a).

1.103 “Finished Product Manufacturing Data” shall mean any and all data and information necessary or useful for the Manufacture of a finished product, packaged and labeled, from the active pharmaceutical ingredients thereof, in tablet, capsule or other form (but expressly excluding the Manufacture of such active pharmaceutical ingredients), that is not included in any CMC Data for such finished product.

 

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1.104 [ * ] Customers” shall have the meaning set forth in Annex Q1.

1.105 [ * ] shall have the meaning set forth in Annex Q2.

1.106 “FTC” shall have the meaning set forth in the recitals to this Agreement.

1.107 “GAAP” shall mean United States generally accepted accounting principles as in effect from time to time, as consistently applied.

1.108 “Generic Version” shall mean, with respect to the Combination Product or a Single Agent Product or Double Agent Product, a product containing the same active pharmaceutical ingredients as the Combination Product or the Single Agent Product or Double Agent Product, as the case may be, with those being the only active pharmaceutical ingredients in such product, and which product is approved in the United States under an Abbreviated New Drug Application (i.e., an ANDA), or in Canada under an Abbreviated New Drug Submission (i.e. an ANDS).

1.109 “Generic Version Launch” shall have the meaning set forth in Section 14.5.

1.110 “Gilead” shall have the meaning set forth in the first paragraph of this Agreement.

1.111 “Gilead Core Improvement” shall mean any Improvement pertaining specifically to Gilead Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of BMS or its Affiliates or the JV in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; provided , however , that Gilead Core Improvements shall not include any Dual Improvements.

1.112 “Gilead Core Technology” shall mean all Gilead proprietary technologies relating specifically to the Exploitation of FTC, TDF, or any combination of FTC and TDF (including, without limitation, the Double Agent Product, but excluding the Combination Product).

1.113 “Gilead Guarantee Agreement” shall mean the guarantee agreement executed by Gilead Parent in favor of BMS and the JV, dated as of the Effective Date, as such agreement may be amended from time to time.

1.114 “Gilead Indemnified Party” shall mean Gilead Sub, Gilead Parent and any of their Affiliates, officers, directors and employees.

1.115 “Gilead Inventions” shall mean any Information and Inventions (whether or not patentable; and Improvements thereto, including BMS Core Improvements to the extent owned by Gilead) conceived, discovered, developed or otherwise made, as necessary to

 

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establish authorship or inventorship under United States copyright or patent law, as the case may be, solely (or, in the case of BMS Core Improvements, solely or jointly) by or on behalf of Gilead or its Affiliates, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials, but excluding any Joint Inventions.

1.116 “Gilead Know-How” shall mean any and all Information and Inventions under the Control of Gilead or its Affiliates as of the Effective Date or at any time during the term of this Agreement that are necessary or reasonably useful for the Exploitation of the Combination Product and are not generally known, but excluding any and all (a) such Information and Inventions to the extent claimed by the Gilead Patents and (b) Joint Know-How.

1.117 “Gilead Licensed Trademarks” shall have the meaning set forth in Section 6.6(a).

1.118 “Gilead Parent” shall have the meaning set forth in the first paragraph of this Agreement.

1.119 “Gilead Patents” shall mean all of the Patents that Gilead or its Affiliates Control as of the Effective Date or at any time during the term of this Agreement that would, in the absence of the license granted by Gilead in Section 6.1(a) and assuming that the TDF and FTC active pharmaceutical ingredients therein were not purchased from Gilead, be infringed by the Exploitation of the Combination Product by the JV in any country in the world. A list of the Gilead Patents in the United States as of the Effective Date is attached hereto as Annex E, and a list of the Gilead Patents in Canada as of the Amended Effective Date is attached hereto as Annex T.

1.120 “Gilead Regulatory Documentation” shall mean all Regulatory Documentation applicable to Viread (or TDF), Emtriva (or FTC), or Truvada (or TDF in co-formulation with FTC) but not Viread (or TDF), Emtriva (or FTC) or Truvada (or TDF and FTC) in co-formulation with Sustiva (or EFV), that is or was developed by or on behalf of Gilead or any of its Affiliates or sublicensees prior to the Effective Date or during the term of this Agreement.

1.121 “Gilead Sub” shall have the meaning set forth in the first paragraph of this Agreement.

1.122 “Gilead Supply Agreement” shall mean the supply agreement entered into between Gilead Parent and the JV as of the Effective Date, as such agreement may be amended from time to time.

1.123 “Gilead Technology” shall mean, collectively, the Gilead Know-How and the Gilead Patents.

1.124 “Gilead Transfer Price” shall have the meaning set forth in Section 7.1(a).

 

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1.125 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.126 “Good Clinical Practice” or “GCP” shall mean the then-current standards for clinical trials for pharmaceutical products, as set forth in the U.S. Act or the Canadian Act, as the case may be, and applicable regulations promulgated thereunder or other Applicable Law, as the same may be amended from time to time.

1.127 “Good Laboratory Practice” or “GLP” shall mean the then-current standards for laboratory activities for pharmaceutical products, as set forth in the U.S. Act or the Canadian Act, as the case may be, and applicable regulations promulgated thereunder or other Applicable Law, as the same may be amended from time to time.

1.128 “Good Manufacturing Practice” or “GMP” shall mean the regulatory requirements under Applicable Law for current good manufacturing practices for pharmaceutical products, including those set forth in U.S. Act and 21 C.F.R. (parts 210, 211, 600 and 610) or set forth in Division 2 of Part C of the Food and Drug Regulations (Canada) and associated guidelines, as the case may be, in each case as amended from time to time.

1.129 “HPFB” shall mean the Canadian Health Products and Food Branch and any successor agency thereto.

1.130 “Improvement” shall mean any modification to a compound, composition, product or technology or to any discovery, device, process or formulation related to such compound, composition, product or technology, whether or not patented or patentable, including, without limitation, any enhancement in the efficiency, operation, Manufacture, ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of a compound, composition, product or technology, or of any discovery, device, process or formulation related thereto; any discovery or development of any new or expanded indications or applications for a compound, composition, product or technology; any discovery or development that improves the stability, safety or efficacy of a compound, composition, product or technology; or any discovery or development of a new dosage regimen for a product or method of use or administration for a compound, composition, product or technology.

1.131 “IND” shall mean an Investigational New Drug Application to be filed with the FDA in accordance with Applicable Law.

1.132 “Indemnified Party” shall mean a Person seeking indemnification for Losses pursuant to Section 13.8.

1.133 “Indemnifying Member Party” shall have the meaning set forth in Section 13.6.

1.134 “Indemnifying Party” shall mean a Party from which indemnification is sought pursuant to Section 13.8.

 

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1.135 “Independent Accounting Expert” shall have the meaning set forth in Section 7.1(d).

1.136 “Information and Inventions” shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including, without limitation, pre-clinical and clinical trial results, Manufacturing procedures, test procedures, and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all Improvements, whether to the foregoing or otherwise, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing.

1.137 “Infringement” shall have the meaning set forth in Section 11.3(a).

1.138 “Infringing Combination Product” shall have the meaning set forth in Section 11.3(a).

1.139 “Initial Launch Period” shall mean, with respect to a country in the Territory, the first [ * ] commencing with the Launch of the Combination Product in such country.

1.140 “Initiating Member” shall have the meaning set forth in Section 7.1(e).

1.141 “Interim BMS Unit Transfer Price” shall have the meaning set forth in Section 7.1(a).

1.142 “Interim Gilead Unit Transfer Price” shall have the meaning set forth in Section 7.1(a).

1.143 “Interim Unit Transfer Price” shall mean, for each Calendar Year, with respect to BMS, the Interim BMS Unit Transfer Price and with respect to Gilead, the Interim Gilead Unit Transfer Price.

1.144 “Joint Commercialization Committee” or “JCC” shall have the meaning set forth in Section 2.4(a).

1.145 “Joint Canadian Operating Committee” or “JCOC” shall have the meaning set forth in Section 2.5(a).

1.146 “Joint Development Committee” or “JDC” shall have the meaning set forth in Section 2.3(a).

1.147 “Joint Executive Committee” or “JEC” shall have the meaning set forth in Section 6.1 of the Operating Agreement.

 

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1.148 “Joint Finance Committee” or “JFC” shall have the meaning set forth in Section 2.6(a).

1.149 “Joint Inventions” shall mean (a) any and all Information and Inventions pertaining specifically to the Combination Product (whether or not patentable; and Improvements thereto) conceived, discovered, developed or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, by or on behalf of BMS or its Affiliates, Gilead or its Affiliates, the JV, or jointly any combination of them, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; and (b) any Dual Improvement.

1.150 “Joint Know-How” means all Information and Inventions included in the Joint Inventions that are not generally known, but excluding any Information and Inventions to the extent claimed by the Joint Patents. For the avoidance of doubt, “Joint Know-How” shall include all Clinical Data from the proposed bioequivalence study contemplated by the Development Plan.

1.151 “Joint Patents” shall mean any Patents to the extent that such Patents claim Joint Inventions.

1.152 “Joint Technology” shall mean, collectively, the Joint Know-How and the Joint Patents.

1.153 “Jurisdiction” shall mean a province or a territory of Canada.

1.154 “JV” shall have the meaning set forth in the first paragraph of this Agreement.

1.155 “JV Expenses” shall mean all direct, out-of-pocket expenses that Gilead or BMS may incur (or cause their Affiliates to incur) in performing the Project Activities on behalf of the JV. For the avoidance of doubt, with respect to any JV Expenses incurred by a Member Party (or its Affiliates), such expenses are chargeable to the JV by such Member Party only if such expenses constitute Authorized Expenses.

1.156 “Key Regulatory Submissions” shall have the meaning set forth in Section 3.4(a).

1.157 “Launch” shall mean, with respect to a country in the Territory, either (a) the date on which the Combination Product is first shipped by or on behalf of the JV for commercial sale to Third Parties in such country or (b) for any Generic Version product referred to in Section 14.5, the date on which it is first available for commercial sale and purchase in such country, as the case may be.

 

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1.158 “Losses” shall mean judgments, fines, amounts paid in settlement, and out-of-pocket expenses (including reasonable attorneys’ fees) reasonably incurred by a Party (or other indemnitee as provided in Section 13) in a Proceeding.

1.159 [ * ]

1.160 [ * ] shall have the meaning set forth in Annex Q1.

1.161 “Manufacture” or “Manufacturing” means, with respect to a product or compound, the manufacturing, processing, formulating, packaging, labeling, holding, and quality control testing of such product or compound.

1.162 “Manufacturing Process” shall mean any process or step thereof that is necessary or useful for Manufacturing the Combination Product from bulk active pharmaceutical ingredients, any Improvements thereto or any intermediate of the foregoing.

1.163 “Market” or “Marketing” shall mean all programs and activities relating to the Promotion and sale and other commercialization of the Combination Product in the Territory, including, without limitation, Detailing and advertising, as well as selling, contracting for sale of, and distributing the Combination Product.

1.164 “Material Default” shall have the meaning set forth in Section 14.4(a).

1.165 “Member Parties” shall mean, collectively, Gilead and BMS.

1.166 “Members” shall mean, collectively, Gilead Sub and BMS Sub.

1.167 “Member Vote” shall have the meaning set forth in Section 2.6(f).

1.168 [ * ] shall have the meaning set forth in Section 5.1(f).

1.169 [ * ] shall have the meaning set forth in Section 5.1(f).

1.170 “MTTA” shall have the meaning set forth in Section 15.14.

1.171 “NDA” shall mean a New Drug Application to be filed with the FDA in accordance with Applicable Law for the purpose of obtaining marketing approval for a pharmaceutical product in the U.S.

1.172 “NDS” shall mean a New Drug Submission to be filed with the HPFB in accordance with Applicable Law for the purpose of obtaining marketing approval for a pharmaceutical product in Canada.

1.173 [ * ] shall have the meaning set forth in Annex Q1.

1.174 “Net Sales” shall mean, with respect to a product for any period, the gross amount invoiced for commercial sales of that product in such period by or on behalf of the

 

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selling Party to Third Parties (provided that amounts invoiced for product sold or provided for use in the Developing World, if any, shall not be included), less deductions for: (a) normal and customary quantity and/or cash discounts and sales returns and allowances, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates, administrative or other fees or reimbursements or similar payments to wholesalers or other distributors (including without limitation pursuant to inventory management agreements), buying groups, AIDS Drug Assistance Programs, pharmacy benefit management organizations, health care insurance carriers or other institutions, allowances, rebates, fees paid to distributors and chargebacks actually allowed or given; (b) freight, postage, shipping and insurance expenses (if separately identified in such invoice); (c) customs or excise duties or other duties related to the sales making up the gross invoice amount (if separately identified in such invoice); (d) any rebates or similar payments accrued with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the foregoing in this clause (d), United States Federal or state Medicaid, Medicare or similar state program or any government imposed retroactive price reduction; and (e) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale). Any of the deductions listed above that involves a payment by such Party shall not be taken as a deduction prior to the date accrued in accordance with GAAP as consistently applied in such Party’s audited financial statements. For purposes of determining Net Sales pursuant to Section 14.6(b)(ii), the Combination Product shall be deemed to be sold when invoiced.

For purposes of calculating Net Sales, sales between or among a Party and/or Affiliates shall be excluded from the computation of Net Sales, but sales by such Party and its Affiliates to Third Parties shall be included in the computation of Net Sales.

1.175 “Net Selling Price” shall mean, with respect to each country in the Territory, the price of a pharmaceutical product as calculated in accordance with Annex I hereto and expressed in the currency of such country, and with respect to the Territory, the weighted average of the Net Selling Prices in each country in the Territory, expressed in U.S. dollars, using the currency conversion rules established pursuant to Section 7.1(f).

1.176 “Non-Breaching Member Party” shall have the meaning set forth in Section 14.4(a).

1.177 “Operating Agreement” shall have the meaning set forth in the recitals to this Agreement.

1.178 “Operating Committees” shall mean, collectively, the JCC, the JCOC, the JDC and the JFC.

1.179 “Optional Update” shall have the meaning set forth in Section 5.7(d).

1.180 “Paragraph (iv) Certification” shall have the meaning set forth in Section 11.3(a).

 

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1.181 “Party” and “Parties” shall have the meanings set forth in the first paragraph of this Agreement.

1.182 “Patents” shall mean (a) all patents and patent applications (including, without limitation, provisional applications), (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and (c) any foreign or international equivalents of any of the foregoing.

1.183 “PCT” shall mean the Patent Cooperation Treaty, opened for signature June 19, 1970, 58 U.S.T. 7645.

1.184 “PMPRB” shall mean the Patented Medicine Prices Review Board of Canada.

1.185 “Permitted Assignee” shall have the meaning set forth in Section 15.4(a).

1.186 “Person” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including, without limitation, a government or political subdivision, department or agency of a government.

1.187 “Prescription Drug Marketing Act” or “PDMA” shall have the meaning set forth in Section 5.1(d).

1.188 “Pricing Liaison” shall have the meaning set forth in Section 5.3B(c).

1.189 “Private Institutional Payor” shall mean a third party payor (such as an insurance company, pharmacy benefit management firm or hospital) of health care expenses incurred by a patient in Canada, which payor is not a provincial, federal or territorial government.

1.190 “Proceeding” shall mean a civil, criminal, administrative or investigative proceeding brought by or a demand made by a Third Party.

1.191 “Product Detail Period” shall have the meaning set forth in Section 5.1(e).

1.192 “Product EFV Yield” shall have the meaning set forth in Annex K.

1.193 “Product FTC Yield” shall have the meaning set forth in Annex K.

1.194 “Product TDF Yield” shall have the meaning set forth in Annex K.

 

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1.195 “Project Activities” shall mean any and all activities undertaken or performed by or on behalf of any of the Parties, pursuant to this Agreement or the MTTA, in the course of, as a result of or in connection with the research, development, Marketing, sale or use of the Combination Product, including, without limitation, the Development Activities and the Commercialization Activities; provided , however , that Project Activities shall not include any activities undertaken or performed by or on behalf of either Member Party or its Affiliates or sublicensees to the extent that they arise in the course of, as a result of or in connection with the Exploitation of the Combination Product for use outside the Territory (including, without limitation, any activities undertaken or performed by Gilead in the exercise of its rights under the license granted in Section 6.2(d)).

1.196 “Promotion” shall mean the conduct of activities normally undertaken by a pharmaceutical company’s Field Force to implement plans and strategies for marketing and other commercialization aimed at encouraging the approved use of a pharmaceutical product, including but not limited to Detailing. When used as a verb, “Promote” shall mean to engage in any of the foregoing activities.

1.197 “PSUR” means a periodic safety update report required to be submitted to an applicable Regulatory Authority in the Territory.

1.198 “Publication Standards” shall have the meaning set forth in Section 3.11(a).

1.199 [ * ] shall have the meaning set forth in Section 5.1(f).

1.200 “Recalculated Transfer Price” shall have the meaning set forth in Section 7.1(c)(iii).

1.201 “Receiving Party” shall have the meaning set forth in Section 12.1.

1.202 “Regulatory Authorities” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, including, without limitation, the FDA and the HPFB, or other entity exercising regulatory authority with respect to the Exploitation of the Combination Product in the Territory.

1.203 “Regulatory Documentation” shall mean all submissions to Regulatory Authorities in the Territory, including, without limitation, all INDs, NDAs, sNDAs, CTAs, NDSs, SNDSs, CMC Data, drug master files, filings with PMPRB, filings for listing with Canadian provincial drug plans, correspondence with regulatory agencies (registrations and licenses, regulatory drug lists, advertising and promotion documents), PSURs, adverse event files, complaint files and manufacturing records.

1.204 “Relevant Experience Information” shall mean adverse experience reports, reports based on marketing data and other documentation of relevant drug experience.

 

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1.205 [ * ] shall have the meaning in Section 5.3B(e).

1.206 “Required Update” shall have the meaning set forth in Section 5.7(b).

1.207 “Respective Percentage” shall mean, with respect to Gilead, the Actual Gilead Percentage, and with respect to BMS, the Actual BMS Percentage; provided , however , that whenever this Agreement provides that an amount shall be allocated between the Member Parties based on their Respective Percentages, such allocation shall first be made on the basis of the Member Parties’ respective Working Percentages at the time of the relevant event, which allocation shall then be adjusted, if applicable, after the determination of the Member Parties’ respective Actual Percentages for the Calendar Year in which the relevant event occurs, which adjustments shall occur no later than April 1 of the next Calendar Year unless otherwise provided in this Agreement or the Operating Agreement, or otherwise agreed in writing by the Member Parties.

1.208 “Right of Reference” shall have the meaning set forth in 21 C.F.R. § 314.3(b) or equivalents thereto under Applicable Law in Canada or jurisdictions outside the Territory. For the avoidance of doubt, as used in this Agreement “Right of Reference” shall refer to the right of Regulatory Authorities to rely upon and otherwise use the applicable information, but shall not confer on the Member Party to which such Right of Reference is granted any right to receive or access such information.

1.209 “SDEA” or “Safety Data Exchange Agreement” shall have the meaning set forth in Section 9.1.

1.210 “Selected Product Liability Claim” shall have the meaning set forth in Section 13.7(c).

1.211 “Services Agreement” shall mean the distribution services agreement to be entered into between Gilead Parent and the JV after the Effective Date, the key terms of which are outlined in Annex P1 hereto, as such agreement may be amended from time to time.

1.212 “Single Agent Product” shall mean each of Viread, Emtriva, and Sustiva.

1.213 “SNDS” shall mean a supplemental NDS.

1.214 “Study 934” shall mean the clinical study initiated by Gilead prior to the Effective Date under Gilead’s clinical study protocol entitled “A Phase 3, Randomized, Open-Label, Multicenter Study of the Treatment of Antiretroviral-Naïve, HIV-1-Infected Subjects comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination with Efavirenz Versus Combivir ® (lamivudine/zidovudine) and Efavirenz” (as such protocol may be revised and such study may be extended or expanded from time to time, in each case by Gilead). For the avoidance of doubt, the conduct of Study 934 shall not be deemed a Development Activity or Project Activity for purposes of this Agreement, and Clinical Data derived or generated from Study 934 or from testing or analysis of subjects or samples from Study 934 shall be Gilead Know-How, not Joint Know-How.

 

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1.215 “Subsequent Launch Period” shall mean, with respect to a country in the Territory, [ * ] after the Launch of the Combination Product in such country.

1.216 “Supplier” shall mean each Person selected as a commercial supplier of the Combination Product pursuant to Section 4.2(a).

1.217 “Supply Agreements” shall mean, collectively, the BMS Supply Agreement and the Gilead Supply Agreement.

1.218 “Supply Party” shall mean, with respect to any Supplier, (a) if a Member Party is the Supplier, such Member Party, or (b) if a Third Party is the Supplier, the Member Party that is designated pursuant to Section 4.2(a) to manage the relationship with such Supplier.

1.219 “TDF” shall have the meaning set forth in the recitals to this Agreement.

1.220 “Technology” shall mean the BMS Technology or the Gilead Technology, as the case may be.

1.221 “Terminated Member Party” shall mean a Member Party as so designated pursuant to Section 14.5.

1.222 “Territory” shall mean Canada and the United States.

1.223 “Third Party” shall mean any Person other than Gilead, BMS, the JV and their respective Affiliates.

1.224 “Third Party Acquirer” shall have the meaning set forth in Section 1.43.

1.225 “Trademark” shall include any word, name, symbol, color, designation or device or any combination thereof, including, without limitation, any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo or business symbol.

1.226 “Transfer Price” shall mean the BMS Transfer Price or the Gilead Transfer Price, as the case may be.

1.227 “Transferring Member Party” shall have the meaning set forth in Section 15.4(b).

1.228 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.229 “United States” or “U.S.” shall mean the United States, the Commonwealth of Puerto Rico and any other territories and possessions of the United States

 

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1.230 “U.S. Act” shall mean the United States Food, Drug and Cosmetic Act, as amended.

1.231 “U.S. Commercialization Budget” shall have the meaning set forth in Section 5.11(b). The U.S. Commercialization Budget as of the Effective Date is attached hereto as Annex C.

1.232 “U.S. Commercialization Plan” shall mean the plan for Marketing and otherwise commercializing the Combination Product in the United States as described in Section 5.11(b), as updated from time to time pursuant to Section 5.11(c). The U.S. Commercialization Plan as of the Effective Date is attached hereto as Annex C.

1.233 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.234 “US Pricing Committee” shall have the meaning set forth in Section 5.3A(b).

1.235 “US Pricing Information” shall have the meaning set forth in Section 5.3A(h).

1.236 [ * ] shall have the meaning set forth in Section 5.3A(a).

1.237 “WAC” shall have the meaning set forth in Annex Q1.

1.238 “Working BMS Percentage” shall mean, for each Calendar Year, the preliminary percentage applicable to BMS for such Calendar Year determined pursuant to Section 7.1(c)(i).

1.239 “Working Gilead Percentage” shall mean, for each Calendar Year, the preliminary percentage applicable to Gilead for such Calendar Year determined pursuant to Section 7.1(c)(i).

1.240 “Working Percentage” shall mean, with respect to BMS, the Working BMS Percentage and, with respect to Gilead, the Working Gilead Percentage.

SECTION 2.

COLLABORATION MANAGEMENT

2.1 General . As set forth in this Agreement and in the Operating Agreement, the Member Parties desire to establish a Joint Executive Committee which shall oversee the Member Parties’ collaboration under this Agreement and facilitate communications between the Member Parties with respect to the development, Approval, Manufacturing and commercialization of the Combination Product in the Territory. Subject to the foregoing, the Member Parties also desire to establish specialized committees to focus more closely on the Parties’ Development Activities, Commercialization Activities and finance activities hereunder. Each such committee shall have only the responsibilities and authority delegated to or vested in such committee in this Section 2 or elsewhere in this Agreement and the Operating Agreement.

 

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2.2 Role of the Joint Executive Committee . The establishment, composition, governance, powers and limitations on powers of the Joint Executive Committee (or “JEC”) are governed by Section 6 of the Operating Agreement and by this Section 2.2. The initial JEC members are identified in Annex A hereto. The JEC shall have overall authority and responsibility with respect to the Development Activities and Commercialization Activities for the Combination Product (except for those matters reserved to the Member Parties pursuant to this Agreement or the Operating Agreement). Without limitation of the foregoing, the JEC shall have the following powers and duties:

(i) to oversee the work of the Operating Committees and, if possible, resolve disputes referred to it by the Alliance Managers pursuant to Section 2.8;

(ii) to oversee the activities of Gilead in keeping the JV’s books and records pursuant to Section 8.1;

(iii) to adopt guidelines for compliance by the Parties with antitrust laws in connection with the JV activities;

(iv) to approve the initial Capital Contributions (as defined in the Operating Agreement) of the Members, to approve each Capital Contribution planning schedule, and to issue certain requests for additional Capital Contributions, in each case pursuant to Section 4.1 of the Operating Agreement;

(v) to approve (x) each annual update of the Development Plan and the Development Budget and (y) any interim update of the Development Plan or Development Budget, as the case may be, as to which the JDC is unable to reach agreement;

(vi) to approve (x) each annual update of the Commercialization Plans and the Commercialization Budgets and (y) any interim update of the Commercialization Plans or Commercialization Budgets, as the case may be, as to which the JCC or JCOC is unable to reach agreement;

(vii) to approve unit volume forecasts as to which the JCC or JCOC is unable to reach agreement for use in preparation of Commercialization Plans and Commercialization Budgets and (regardless of whether there is a Commercialization Plan or Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for Commercialization Activities and for the Member Parties’ own financial planning purposes;

(viii) to approve Cost Allocation Proposals;

(ix) to approve the JFC’s reports on financial matters that the JEC determines to be reasonably necessary or appropriate for the implementation of the financial aspects of the JV;

 

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(x) to review recommendations of the JFC with respect to, and approve, one or more means of reconciling, one to the other, the internal reporting and accounting standards of each of the Member Parties where reasonably necessary, and methods of charging costs and expenses of each of the Member Parties;

(xi) to review and, if applicable, recommend to the Member Parties changes to the [ * ] pursuant to Section 5.3A(i);

(xii) to resolve disputes within the JDC with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the other Member Party with access to certain of such Member Party’s records, documentation and data;

(xiii) to resolve disputes within the JCC or JCOC with respect to (A) the initially proposed marketing materials for the Combination Product for the applicable country in the Territory, and thereafter, updates of any Approved Marketing Materials, (B) a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data, (C) issues relating to the patient assistance programs arising under Section 2.4(b)(vii) and (D) issues relating to Suppliers and alternate suppliers arising under Section 2.4(b)(ix);

(xiv) to decide major strategic issues and any other matters relating to the JV that are not (i) within the purview of the Operating Committees or (ii) reserved to the Member Parties pursuant to this Agreement or the Operating Agreement;

(xv) to determine whether Launch of the Combination Product in Canada should occur and, if so, the timing thereof; and

(xvi) to take such other actions as are reserved to the JEC in this Agreement or the Operating Agreement or as the Parties may mutually agree in writing, except that the JEC may not amend or take any action that would conflict with any provision of this Agreement, the Operating Agreement or any Ancillary Agreement and may not resolve any issue regarding termination of this Agreement for a potential or actual Material Default.

2.3 Joint Development Committee .

(a) Each Member shall appoint four (4) members of a joint development oversight and management committee (the “Joint Development Committee” or “JDC”). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to serve as chairperson of the JDC through the first anniversary of the Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JDC members and the chairperson are identified in Annex A hereto.

 

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(b) Subject to the oversight of the JEC, the JDC shall have the following powers and duties:

to (x) review and propose to the JEC for its approval each annual update of the Development Plan and Development Budget and (y) review and approve each interim update of the Development Plan and Development Budget, in each case proposed pursuant to Section 3.7;

to oversee and coordinate the Parties’ activities under the Development Plan;

to oversee and manage matters relating to clinical supply of the Combination Product, including, without limitation, Manufacturing requirements, inventory projections and inventory control;

with the Alliance Managers, (x) to assist in coordinating scientific interactions between the Parties during the course of implementing the Development Plan and (y) to facilitate the exchange among the Parties of data, information, materials and results relating to clinical manufacturing, clinical trials, and communications and filings with Regulatory Authorities for the Combination Product (in each case solely to the extent that such data, information and materials are required to be exchanged among the Parties, or with respect to which one Member Party has the right to gain access from the other Member Party or the JV, pursuant to this Agreement or the Operating Agreement);

to oversee regulatory matters for the JV, including, without limitation, approving all Combination Product Regulatory Documentation to the extent required pursuant to Section 3.4, overseeing Gilead’s activities as the JV’s liaison with Regulatory Authorities in the Territory, and overseeing the activities conducted pursuant to the SDEA and other pharmacovigilance and safety reporting;

to oversee the Member Parties’ activities pursuant to their respective Supply Agreements and to oversee and coordinate with the JCC with respect to matters relating to the monitoring of Manufacturing capacity, forecasts and orders for the active pharmaceutical ingredients of the Combination Product;

to resolve disputes between the Member Parties with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the other Member Party with access to certain of such Member Party’s records, documentation and data;

to oversee medical affairs and medical communications activities;

to review and approve or reject proposals for Phase IV clinical studies of the Combination Product;

to provide updates on the JDC’s activities and achievements to the JEC each Calendar Quarter; and

to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.4 Joint Commercialization Committee .

(a) Each Member shall appoint four (4) members of a joint commercialization oversight and management committee (the “Joint Commercialization Committee” or “JCC”). BMS Sub shall appoint one (1) of the members designated by BMS Sub, to serve as chairperson of the JCC through the first anniversary of the Effective Date. Thereafter a member designated by Gilead Sub and then a member designated by BMS Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JCC members and the chairperson are identified in Annex A hereto.

 

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(b) Subject to the oversight of the JEC, the JCC shall have the following powers and duties:

to oversee and coordinate the Parties’ activities under the U.S. Commercialization Plan;

to (x) review and propose to the JEC for its approval each annual update of the U.S. Commercialization Plan and U.S. Commercialization Budget and (y) review and approve each interim update of the U.S. Commercialization Plan and U.S. Commercialization Budget, in each case proposed pursuant to Section 5.11(c);

to oversee Gilead’s activities pursuant to the Services Agreement with respect to the distribution of the Combination Product in the United States;

to develop and approve (x) initial marketing materials for the Combination Product in the United States, and (y) updates to such materials from time to time as may be reasonably necessary or appropriate, all in accordance with Section 5.7;

to develop and approve unit volume forecasts for use in preparation of the U.S. Commercialization Plans and U.S. Commercialization Budgets and (regardless of whether there is a U.S. Commercialization Plan or U.S. Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for Commercialization Activities in the United States and for the Member Parties’ own financial planning purposes;

to (x) determine how the JV will respond to requests in the United States from health care providers or from individual patients who have or may obtain prescriptions for the Combination Product but are unable to afford it, and (y) to establish the appropriate procedures and response times that shall apply in responding to such requests in the United States, in each case ((x) and (y)) in accordance with Section 5.2(a);

to make recommendations to the JEC with respect to Cost Allocation Proposals relating to costs in the United States;

to maintain one Supplier and one or more alternate suppliers pursuant to Section 4.2(a) for Manufacture of commercial supplies of the Combination Product;

oversee and coordinate with the JDC with respect to matters relating to the Manufacturing and labeling of the Combination Product for commercial supply in the United States, including, in the case of Manufacturing, with respect to quality control matters, and the monitoring of Manufacturing capacity, forecasts and orders for the Combination Product to ensure adequate commercial supply to meet the demand therefor in the United States as projected by the JCC and approved by the JEC;

to resolve disputes between the Member Parties with respect to a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data relating to Commercialization Activities in the United States;

to provide updates on the JCC’s activities and achievements to the JEC each Calendar Quarter; and

to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.5 Joint Canadian Operating Committee .

(a) Each Member shall appoint three (3) members of a joint oversight and management committee for commercialization in Canada (the “Joint Canadian Operating

 

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Committee” or “JCOC”). BMS Sub shall appoint one (1) of the members designated by BMS Sub, to serve as chairperson of the JCOC through the first anniversary of the Amended Effective Date. Thereafter a member designated by Gilead Sub and then a member designated by BMS Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Amended Effective Date. The initial JCOC members and the chairperson shall be designated by the applicable Party promptly after the Amended Effective Date.

(b) Subject to the oversight of the JEC, the JCOC shall have the following powers and duties:

to oversee and coordinate the Parties’ activities under the Canadian Commercialization Plan;

to (x) review and propose to the JEC for its approval each annual update of the Canadian Commercialization Plan and Canadian Commercialization Budget and (y) review and propose to the JEC for its approval each interim update of the Canadian Commercialization Plan and Canadian Commercialization Budget, in each case proposed pursuant to Section 5.11(c);

to oversee Gilead’s activities pursuant to the Canada Distribution and Supply Agreement with respect to the distribution of the Combination Product in Canada;

to develop and approve (x) initial marketing materials for the Combination Product for Canada, and (y) updates to such materials from time to time as may be reasonably necessary or appropriate, all in accordance with Section 5.7;

to develop and approve unit volume forecasts for use in preparation of the Canadian Commercialization Plans and the Canadian Commercialization Budgets and (regardless of whether there is a Canadian. Commercialization Plan or Canadian Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for the Commercialization Activities in Canada and for the Member Parties’ own financial planning purposes;

to (x) determine how the JV will respond to requests from Canadian health care providers or from individual patients who have or may obtain prescriptions for the Combination Product in Canada but are unable to afford it, and (y) appropriate procedures and response times that shall apply in responding to such requests in Canada, in each case ((x) and (y)) in accordance with Section 5.2(a);

to make recommendations to the JEC with respect to Cost Allocation Proposals relating to costs in Canada;

coordinate with the JDC with respect to matters relating to the Manufacturing and labeling of the Combination Product for commercial supply in Canada, including, in the case of Manufacturing, with respect to quality control matters, and the monitoring of Manufacturing capacity, forecasts and orders for the Combination Product to ensure adequate commercial supply to meet the demand therefor in Canada as projected by the JCOC and approved by the JEC;

to resolve disputes between the Member Parties with respect to a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data relating to Commercialization Activities in Canada;

to provide updates on the JCOC’s activities and achievements to the JEC each Calendar Quarter; and

 

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to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.6 Joint Finance Committee .

(a) Each Member shall appoint two (2) members of a joint finance committee to support the JEC, the JDC, the JCC and the JCOC (the “Joint Finance Committee” or “JFC”). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to serve as chairperson of the JFC through the first anniversary of the Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JFC members and the chairperson are identified in Annex A hereto.

(b) Subject to the oversight of the JEC, the JFC shall have the following powers and duties:

to work with the JEC and the other Operating Committees to assist in financial, budgeting and planning matters as required, including assisting in the preparation of budgets and annual and long-term plans;

to recommend, for approval by the JEC, procedures, formats and timelines consistent with this Agreement for reporting financial data as well as additional or alternative reporting procedures concerning financial aspects of the JV;

to prepare such reports on financial matters as are approved by the JEC for the implementation of the financial aspects of the JV;

to coordinate audits of financial data where appropriate and required or allowed by this Agreement;

to address issues of implementation relating to the financial mechanics and calculations under this Agreement and the Operating Agreement;

to recommend, for approval by the JEC, a means of reconciling, one to the other, the internal reporting and accounting standards of each of the Member Parties where necessary and methods of charging costs and expenses of each of the Member Parties;

to review the appropriate allocation of costs and expenses with respect to Authorized Expenses ;

to calculate or cause to be calculated, as the case may be, those matters expressly required to be calculated (or caused to be calculated) by the JFC pursuant to this Agreement, including Sections 7.1(c) and 7.1(d), and pursuant to the Operating Agreement, and to address issues of implementation relating to the cash netting procedures set forth in Section 4.1(c) of the Operating Agreement;

to develop and recommend to the JEC for approval the initial Capital Contributions (as defined in the Operating Agreement) of the Members and each Capital Contribution planning schedule, and to recommend to the JEC certain requests for additional Capital Contributions, in each case pursuant to Section 4.1 of the Operating Agreement;

to provide updates on the JFC’s activities and achievements to the JEC each Calendar Quarter; and

to perform such other functions as the Member Parties may mutually agree in writing from time to time.

 

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2.7 Procedural Rules of the Operating Committees .

(a) Each of BMS Sub and Gilead Sub shall designate representatives with appropriate expertise to serve as members of each Operating Committee, and each representative may serve on more than one (1) Operating Committee (and/or the JEC) as appropriate in view of the individual’s expertise. The Members shall endeavor to match their respective representation on each Operating Committee, in terms of functional areas and management level.

(b) A member of an Operating Committee may be removed or replaced at any time, with or without cause, by the Member that appointed such committee member. Such action shall be accomplished by written notice to the other Member. Each member of an Operating Committee shall serve until a successor is named by the Member that appointed such committee member (or until his or her earlier resignation or removal).

(c) The JFC shall meet at least one (1) time per Calendar Quarter during the term of this Agreement. The JDC shall meet at least one (1) time per Calendar Quarter until the first anniversary of the later to occur of the Launch of the Combination Product in the United States and the Launch thereof in Canada (or termination of this Agreement with respect to Canada pursuant to Section 14.3), and thereafter at least semiannually (or on such other schedule as may be determined by the JDC). The JCC shall meet at least one (1) time per Calendar Quarter until the second anniversary of the Launch of the Combination Product and thereafter at least semiannually (or on such other schedule as may be determined by the JCC). The JCOC shall meet at least one (1) time per Calendar Quarter until the second anniversary of the Launch of the Combination Product in Canada. Each Operating Committee other than the JCOC shall meet at times and places in the United States mutually agreed by BMS Sub and Gilead Sub. The JCOC shall meet at times and places mutually agreed by BMS Sub and Gilead Sub. The respective Operating Committees shall meet to discuss the overall progress of the Development Activities in the Development Plan or Commercialization Activities in the Commercialization Plans, or the financial aspects of the JV, as the case may be, and any problems arising in the course of such activities; the status of the Development Plan and Development Budget, the Commercialization Plans and Commercialization Budgets, or other financial aspects of the JV, as the case may be; and any other matter that a member of such Operating Committee may reasonably request. Each Operating Committee shall keep accurate and complete minutes of its meetings to record all proposals, recommendations and actions taken. All such minutes and other records of each Operating Committee shall be available to each Member Party.

(d) The chairperson shall organize committee meetings, prepare the meeting agenda based on items submitted by committee members, take or cause to be taken accurate minutes of meetings, circulate draft minutes within seven (7) days after the meeting for approval by the other Member’s committee members, and circulate final minutes to the committee members promptly following such approval. Notice of, and the agenda for, each meeting (and any accompanying materials) shall be circulated to the members of the applicable Operating Committee sufficiently in advance so that in the normal course such materials will be received at least five (5) Business Days in advance of such meeting; provided , however , that under reasonable circumstances such materials may be circulated within a lesser period of time in advance of the meeting, so long as each Member agrees to the inclusion on such agenda of any

 

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items proposed for consideration by the other Member. Any member of an Operating Committee may waive notice of a meeting thereof, and shall be deemed to waive such notice (but not, if applicable, his or her right to object to the inclusion of a particular agenda item or items as set forth in the proviso to the previous sentence) if he or she attends the meeting and does not object to the meeting because of a lack of notice prior to its commencement.

(e) At least two (2) members appointed by Gilead Sub and two (2) members appointed by BMS Sub must be in attendance at a meeting of an Operating Committee to establish a quorum for the conduct of business. Committee members may attend meetings in person or, as long as each attendee is able to hear the others, by telephone or by video conference equipment; provided , however , that at least two (2) meetings per Calendar Year of each Operating Committee shall be held in person until the Launch of the Combination Product in the United States, and thereafter at least one (1) meeting per Calendar Year of each Operating Committee shall be held in person. Each Operating Committee may also act by unanimous written consent of its members without a meeting.

(f) At each meeting of an Operating Committee, each Member’s designees on such Operating Committee shall, collectively, have one (1) vote on all matters to be acted upon (the “Member Vote”). Each Operating Committee shall take action by unanimous Member Vote. If an Operating Committee is unable to reach agreement on a matter properly presented to such Operating Committee for its consideration, the matter shall be resolved by the procedure set forth in Section 2.9 (except as otherwise provided therein).

(g) Each Operating Committee may, as it deems appropriate, delegate its decision-making authority for specific matters or types of matters (other than, as applicable in the case of the JDC and JCC, approval of updates of the Development Plan, any Commercialization Plans, Development Budget or any Commercialization Budget for which that Operating Committee is responsible, or as provided in Section 3.4) to subcommittees or specific groups, each with representatives from both Members, which shall make such decisions by consensus. If such subcommittees or groups do not reach consensus on a matter, either Member may refer such matters back to such Operating Committee for resolution.

(h) Notwithstanding the enumerated authority of the JEC in this Agreement and the Operating Agreement and the express reservation to the decision-making authority of the Member Parties of certain matters herein and therein: in the event that the JEC, acting (i) by unanimous affirmative Member Votes (as defined in the Operating Agreement) pursuant to Section 6.5(d) of the Operating Agreement, or (ii) by unanimous written consent pursuant to Section 6.5(c) of the Operating Agreement, takes action on a matter relating to the Exploitation of the Combination Product, but with respect to which matter authority and responsibility have not been delegated to or vested in the JEC, the Member Parties shall be deemed to waive any objection to the effect that the JEC acted beyond the scope of its authority or responsibility, and the resolution of such matter shall be binding on the Member Parties for purposes of this Agreement and the Operating Agreement.

 

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2.8 Alliance Managers .

(a) Gilead and BMS shall each designate within their respective organizations an alliance manager (an “Alliance Manager”) with responsibility for facilitating the interaction and cooperation between Gilead and BMS with respect to the JV and the Exploitation of the Combination Product in the Territory. The initial Alliance Managers are identified in Annex A hereto. Each Member Party may change its Alliance Manager from time to time upon written notice to the other Member Party.

(b) The Alliance Managers shall attend all meetings of the JEC and each Operating Committee (other than the JFC and JCOC) and support the chairpersons of the JEC and each Operating Committee in the discharge of their responsibilities. The Alliance Managers shall be nonvoting participants in such meetings, unless they are also appointed members of the applicable committee(s). Each Alliance Manager shall endeavor to create and maintain a collaborative work environment within and among the JEC and the Operating Committees. In addition, each Alliance Manager: (i) shall be the point of first referral in certain matters subject to dispute resolution as provided in Section 2.9; (ii) shall coordinate the relevant functional representatives of the Member Parties; (iii) shall provide a single point of communication for seeking consensus both internally within the respective Member Parties’ organizations and between the Member Parties; (iv) shall identify and bring disputes to the attention of the JEC or an Operating Committee as appropriate in a timely manner; (v) shall plan and coordinate cooperative efforts and internal and external communications; and (vi) shall take responsibility for ensuring that governance activities, such as the conduct of required JEC and Operating Committee meetings and production of meeting minutes, occur as set forth in this Agreement and in the Operating Agreement and that relevant action items agreed upon at such meetings are appropriately carried out or otherwise addressed.

(c) Notices given by a Member Party to the other Member Party with respect to Development Activities, Combination Product or EFV, TDF or FTC bulk active pharmaceutical ingredient Manufacturing and Commercialization Activities shall be made to the other Member Party’s Alliance Manager and to such other Operating Committee or JEC member of such other Member Party as is most directly involved in or informed of the relevant activity, except that if Gilead or BMS is selected as the Supplier pursuant to Section 4.2(a), it shall not be required to provide such notice to the other Member Party’s Alliance Manager with respect to its toll manufacturing activities.

2.9 Dispute Resolution .

(a) Disputes may be referred to the JEC for resolution, as follows: (i) if an Operating Committee is unable to reach agreement on a matter properly presented to such Operating Committee for its decision, the Operating Committee shall refer the matter to the Alliance Managers for Gilead and BMS, and if the Alliance Managers are unable to resolve the dispute within [ * ] after such referral, then the matter shall be referred to the JEC; and (ii) either Member Party may refer to the JEC any issue arising under this Agreement or the Operating Agreement and not otherwise covered by clause (i).

(b) If the JEC is unable to resolve a dispute referred to it by the Alliance Managers or by a Member Party pursuant to Section 2.8(a) within [ * ] after such

 

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referral, or in the event that the JEC is unable to resolve a dispute arising within the JEC, then the dispute shall be referred for resolution to the Chief Executive Officer of Gilead Parent and, for BMS, the Chief Executive Officer of BMS Parent or any direct report designated by the Chief Executive Officer of BMS Parent (who shall not be a member of the JEC or any Operating Committee).

(c) If the Chief Executive Officer of Gilead Parent and Chief Executive Officer (or designee, as applicable) of BMS Parent are unable to reach agreement on a disputed matter referred to them pursuant to Section 2.9(b) within [ * ] after such referral, then either Gilead or BMS may refer the disputed matter to binding arbitration pursuant to Section 15.6 if and only if, and to the extent that (A) the disputed matter relates to or arises out of the validity, interpretation or construction of, or the compliance with or breach of, this Agreement, the Operating Agreement, any Ancillary Agreement, or any other agreement contemplated by this Agreement to which a Member Party (or its Affiliates) and the JV and/or the other Member Party (or its Affiliates) are parties; (B) the disputed matter came before the JEC pursuant to Section [ * ], or Section [ * ] (provided that any dispute relating to the [ * ] may be submitted to arbitration only with respect to the issue of whether specific [ * ] are [ * ], any dispute relating to [ * ] pursuant to [ * ] may be submitted to arbitration only with respect to the issue of [ * ], any dispute relating to [ * ] may be submitted to arbitration only with respect to matters arising pursuant to [ * ] may be submitted to arbitration only with respect to matters arising pursuant to [ * ]; or (C) there is a dispute as to whether the [ * ] are satisfied with respect to a matter.

(d) For the avoidance of doubt, the dispute resolution procedures set forth in Sections 2.9(a), 2.9(b) and 2.9(c) shall not apply to any deadlock within the JEC or any Operating Committee resulting from a proposal by one Member’s committee members to reverse or modify a decision of the JEC or such Operating Committee with respect to a matter previously presented to it for decision and approved by unanimous Member Vote or unanimous written consent of its members, unless all of the following conditions are satisfied: (i) such proposal is [ * ] the applicable JEC or Operating Committee decision; (ii) the deadlock involves [ * ]; and (iii) the applicable JEC or Operating Committee decision, if not reversed or modified, would [ * ] pursuant to this Agreement (it being understood that if only certain aspects of the applicable JEC or Operating Committee decision produce these results, only they shall be subject to the dispute resolution procedures set forth in Sections 2.9(a), 2.9(b) and 2.9(c), and the balance of such decision shall remain in effect); provided , however , that this Section 2.9(d) shall not apply to the deliberations and decisions of the JCC pursuant to Sections [ * ], and deliberations and decisions of the JEC with respect to any disputes that arise within the JCC with respect thereto; and provided , further , that the JCC’s and the JEC’s reconsideration of prior decisions with respect to the matters covered by the preceding proviso shall be governed by [ * ], respectively, and in the event of any such reconsideration (and any dispute resolution and arbitration in connection therewith), the prior decision in force at the time of reconsideration shall remain in force and continue to apply until such time, if any, as a modified position may be agreed by the JCC or the JEC, or adopted by the arbitrator(s), as the case may be.

(e) Nothing in this Section 2.9 shall affect the right of a Member Party to exercise its rights under Section 14.4 with respect to a Material Default by the other Member Party, concurrently with the exercise of its rights under this Section 2.9. In the event that, at any

 

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time prior to completion of the dispute resolution procedures set forth in this Section 2.9, the Non-Breaching Member Party delivers a notice of Material Default to the Breaching Member Party, the sixty (60) day cure period referred to in Section 14.4(a) shall begin to run upon the receipt of such notice and shall run concurrently with the procedures set forth in this Section 2.9.

2.10 Collaboration Principles . The Parties agree to abide by the following principles (“Collaboration Principles”) in their conduct of the Development Activities and the Commercialization Activities, and to cause their representatives on the JEC and the Operating Committees to observe these principles in connection with their committee-related activities:

(a) Subject to Sections 2.10(b) and (c), the purposes of the JV are (i) to develop, manufacture, and commercialize the Combination Product for use within the Territory, and (ii) to optimize the commercial potential of the Combination Product within the Commercialization Plans, subject to the applicable Commercialization Budget. For the avoidance of doubt, nothing in this Agreement or in the Operating Agreement shall be deemed to restrict or prohibit either Member Party or any of its Affiliates from (x) commercializing its Single Agent Product(s) and/or Double Agent Product as applicable, (y) subject to Sections 3.10 and 5.6, developing, manufacturing and commercializing combination products (other than the Combination Product) for the treatment of HIV infection or otherwise, including, without limitation, any product containing such Party’s Single Agent Product(s) and/or Double Agent Product or (z) conducting clinical studies involving one or more of EFV, FTC and TDF, or any combination thereof (including the Combination Product).

(b) Subject to Section 5.7, each Party’s Promotion of the Combination Product in the Territory shall be in accordance with the Approved Marketing Materials, and the label and the package insert for the Combination Product approved by the applicable Regulatory Authority; provided , however , that subject to the foregoing, each Party shall have a right to position the Combination Product within its HIV product portfolio in its sole discretion.

(c) Except as expressly provided otherwise in this Agreement (or in the Operating Agreement or any Ancillary Agreement) and notwithstanding the powers and authority delegated to a Party, the JEC or an Operating Committee, neither Party shall have any obligation (i) to conduct activities in support or furtherance of the Exploitation of the Combination Product, unless mutually agreed in writing by the Parties or expressly set forth in this Agreement, any Commercialization Plan or the Development Plan, or (ii) to make payments or incur expenses or liabilities in support or furtherance of the Exploitation of the Combination Product unless mutually agreed in writing by the Parties or expressly set forth in the Commercialization Budgets or the Development Budget.

 

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2.11 Commercialization Budget/Plan Deadlocks . In the event of a Commercialization Budget Deadlock or a Commercialization Plan Deadlock (as such terms are defined below) with respect to any portion of the period from the Effective Date through the end of the Subsequent Launch Period in the United States or Canada, as applicable, then in lieu of any other dispute resolution procedures set forth in this Agreement or in the Operating Agreement, the Parties agree that the dispute shall be conclusively resolved as follows:

(a) If a Commercialization Budget Deadlock relates to any Calendar Year (or part thereof) during the period from the Effective Date through the end of the Initial Launch Period in a Commercialization Budget, the level of aggregate expenditure for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (i) in the case of disputes on annual updates, the level for the Calendar Year in dispute provided for in the initial version of such Commercialization Budget included in Annex C or Annex U hereto (as most recently updated, if applicable), or (ii) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year.

(b) If a Commercialization Budget Deadlock relates to any Calendar Year (or part thereof) during the Subsequent Launch Period in a Commercialization Budget, (i) the level of aggregate expenditure for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (A) in the case of disputes on annual updates, [ * ] of the level (as most recently updated) budgeted for the Calendar Year immediately preceding the Calendar Year in dispute unless both Members, through their respective representatives on the JEC have proposed levels of aggregate expenditure both of which are lower than the aforesaid [ * ] level, in which case the level of aggregate expenditure for the Calendar Year in dispute shall instead be fixed at the [ * ] of the [ * ] by the Members through their respective representatives on the JEC, or (B) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year, and (ii) if there is a dispute regarding the level of aggregate expenditure provided for in a subsequent annual update to such Commercialization Budget covered by the foregoing clause (A), such level shall be fixed, upon notice given by a Member Party to the other Member Party, at the amount [ * ] which is the [ * ] of the [ * ] by the Members through their respective representatives on the JEC.

(c) If a Commercialization Plan Deadlock relates to any Calendar Year (or part thereof) during the Initial Launch Period in a Commercialization Plan, the [ * ] for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (i) in the case of disputes on annual updates, the level for the Calendar Year in dispute provided for in the initial version of such Commercialization Plan included in Annex C or Annex U hereto (as most recently updated, if applicable), or (ii) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year.

(d) If a Commercialization Plan Deadlock relates to any Calendar Year (or part thereof) during the Subsequent Launch Period in a Commercialization Plan, (i) the [ * ] for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (A) in the case of disputes on annual updates, [ * ] of the level (as most recently updated) in effect for the Calendar Year immediately preceding the Calendar Year in dispute, unless both Members, through their respective representatives on the JEC, have proposed [ * ] both of which are lower than the aforesaid [ * ] level, in which case the [ * ] for the Product Year in dispute shall instead be fixed at the [ * ] of the [ * ] by the Members through their respective representatives on the JEC, or (B) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year, and (ii) if there

 

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is a dispute regarding the [ * ] provided for in a subsequent annual update to such Commercialization Plan covered by the foregoing clause (A), such level shall be fixed, upon notice given by a Member Party to the other Member Party, at the amount (which [ * ] is the [ * ] of the [ * ] by the Members through their respective representatives on the JEC.

For Calendar Years (or any part thereof) commencing after the Subsequent Launch Period, any aggregate expenditures in the Commercialization Budget for a country in the Territory, and any [ * ] in the Commercialization Plan for such country, shall be decided by the mutual agreement in writing of the Member Parties; failure to reach agreement thereon shall not be subject to dispute resolution hereunder. As used in this Agreement, (x) a “Commercialization Budget Deadlock” shall mean that the JEC is unable to reach agreement, by unanimous Member Vote (as defined in the Operating Agreement) or unanimous written consent of the members of the JEC, on the level of aggregate expenditure in any annual or (in the case of clause (y) of Section 2.2(vi)) interim update to any Commercialization Budget covering all or any portion of the period from the Effective Date through the end of the Initial Launch Period for such country or all or any portion of the Subsequent Launch Period for such country, and (y) a “Commercialization Plan Deadlock” shall mean that the JEC is unable to reach agreement, by unanimous Member Vote or unanimous written consent of the members of the JEC, on the [ * ] to be conducted in any annual or (in the case of clause (y) of Section 2.2(vi)) interim update to a Commercialization Plan covering all or any portion of the Initial Launch Period or the Subsequent Launch Period for such country.

2.12 Expenses . Gilead and BMS shall each bear their own expenses related to the management of the JV, including without limitation all expenses relating to the meetings of the JEC and the Operating Committees, the participation of the Members’ representatives in such meetings, communications with the other Member in connection with such meetings or matters within the authority of the committees, and travel to and from such meetings, and such expenses shall not be deemed JV Expenses or Authorized Other Expenses.

SECTION 3.

DEVELOPMENT ACTIVITIES

3.1 General . Under the oversight of the JDC, Gilead and BMS shall each perform, or cause its Affiliates to perform, on behalf of and in the name of the JV, the Development Activities designated for such Member Party in the Development Plan, in each case in accordance with the timeline set forth in the Development Plan. For the avoidance of doubt, Gilead, on its own behalf and in its own name, shall have the sole right to [ * ] in its sole discretion and without oversight by the JDC or the JEC, but shall [ * ] with respect to [ * ] of such [ * ].

3.2 Clinical Development .

(a) Without limitation of Section 3.1, Gilead, under the oversight of the JDC, shall have primary responsibility for the development of the Combination Product and the conduct of any clinical trials and bioequivalence studies required for obtaining approval of (i) an NDA for the Combination Product in the United States in the Field, and (ii) an NDS for the

 

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Combination Product in Canada in the Field, in each case only as set forth in the Development Plan or otherwise mutually agreed upon by the Member Parties.

(b) In the event that either Member Party desires (i) to conduct or sponsor, or cause to be conducted or sponsored, jointly with the other Member Party, or in the name of the JV, a clinical trial of the Combination Product (whether such clinical trial would involve the Combination Product alone, or with one or more other products) other than any clinical trial contemplated by the Development Plan, including, without limitation, an expanded access program or Phase IIIb/IV study, or (ii) to support jointly with the other Member Party (either on their own behalf or in the name of the JV) any such clinical trial sponsored by an investigator, such Member Party shall so notify the other Member Party. The Member Parties shall then discuss the particulars of the proposed clinical trial. In the event that the Member Parties, each in its sole discretion, agree to conduct jointly or sponsor jointly such clinical trial (either on their own behalf or in the name of the JV), the JDC representatives shall prepare and agree upon a trial protocol and designate a Member Party to take the lead in conducting or supervising such clinical trial and negotiating any necessary clinical trial agreements, as the case may be, and the external, out-of-pocket costs of the Member Parties, if any, without any markup, relating to such clinical trial shall be treated as Authorized Development Expenses. In the event that the Member Parties, each in its sole discretion, agree to support jointly (either on their own behalf or in the name of the JV) any investigator-sponsored clinical trial, the Member Parties shall coordinate with the investigator seeking to conduct such clinical trial and agree upon an appropriate grant of support (including, without limitation, support in the form of funding or the contribution of drug product), and the external, out-of-pocket costs of the Member Parties, if any, without any mark up, with respect to such clinical trial shall be treated as Authorized Development Expenses. Each clinical trial that the Member Parties shall determine to conduct, sponsor or support jointly pursuant to the preceding two sentences shall be referred to as a “Co-Funded Clinical Trial.” The Clinical Data with respect to any Co-Funded Clinical Trial shall be deemed to be Joint Know-How; provided , however , that, in the case of any investigator-sponsored clinical trial, the Clinical Data resulting from any such Co-Funded Clinical Trial shall be deemed to be Joint Know-How only if and to the extent that the JV or either or both Member Parties obtains any right, title and interest in and to such Clinical Data.

For the avoidance of doubt, nothing contained in this Section 3.2 is intended, or shall be construed, to restrict or prohibit either Member Party from conducting independently or together with one or more Third Parties, any clinical trial of the Combination Product (whether such clinical trial would involve the Combination Product alone, or with one or more other products). Prior to a Member Party’s commencing any such clinical trial sponsored by such Member Party, whether independently or together with one or more Third Parties, the applicable Member Party shall provide a brief summary of the protocols to the other Member Party’s representatives on the JDC (it being understood that neither such representatives nor the JDC shall have any approval rights with respect to such study or protocols), provided that (A) each such summary shall constitute Confidential Information of the disclosing Member Party to the extent that the information provided in such summary satisfies the criteria set forth in Section 12.3, (B) the receiving Member Party’s representatives shall not use such summary for any purpose other than providing comments thereon to the disclosing Member Party (which

 

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comments may be accepted or rejected by the disclosing Member Party in its sole discretion), and (C) the receiving Member Party’s representatives shall not disclose such summary to any Persons other than employees of such Member Party who have an obligation (x) not to further disclose such summary and (y) to use such summary solely in order to assist such Member Party’s representatives in providing comments thereon. For the avoidance of doubt, a Member Party’s providing such summary with respect to any such clinical trial pursuant to this Agreement shall not be construed to have the effect of causing the activities with respect to such clinical trial to be deemed to be Project Activities for purposes of this Agreement.

(c) In the event that the Member Parties determine to conduct additional Development Activities for an alternative formulation or presentation of the Combination Product, and conduct or cause to be conducted such additional activities, the external, out-of-pocket costs of the Member Parties, if any, without any markup, with respect to such activities shall be treated as Authorized Development Expenses.

3.3 Formulation and CMC Data . Without limitation of Section 3.1, Gilead, under the oversight of the JDC, shall have primary responsibility for formulation and Manufacturing Process development for, and preparation of the CMC Data relating to, the Combination Product as contemplated by the Development Plan. Formulation development shall include, without limitation, conducting the formulation screening, optimization, scale-up and technology transfer for the Combination Product in the Field.

3.4 Regulatory Matters .

(a) Without limitation of Section 3.1, Gilead, under the oversight of the JDC and with the participation of BMS as described in this Section 3.4, shall have primary responsibility for preparing and filing all necessary Regulatory Documentation and for acting as liaison on behalf of the JV for all communications with the Regulatory Authorities in the Territory relating to the obtaining of approval of the Combination Product in the Field, in the case of the United States, under an NDA separate from the respective NDAs for Sustiva, Viread, Emtriva and Truvada, and in the case of Canada, under an NDS separate from the respective NDSs for Sustiva, Viread, Emtriva and Truvada. Gilead shall prepare and file all Combination Product Regulatory Documentation with Regulatory Authorities in the Territory in the name of the JV. All submissions of Combination Product Regulatory Documentation consisting of any INDs, NDAs, sNDAs, CTAs, NDSs, SNDSs, CMC Data, drug master files and PSURs (collectively, the “Key Regulatory Submissions”) shall be approved in advance by the JDC (which shall not delegate such approval to any subcommittees or groups referred to in Section 2.6(g)). If permitted by Applicable Law, the label for the Combination Product shall list the agents in the following order: [ * ]. For the avoidance of doubt, this Section 3.4(a) shall not apply with respect to obtaining and maintaining the [ * ].

(b) Gilead shall notify BMS as early as reasonably practicable in advance of all meetings (whether face to face or by teleconference) and communications with representatives of the Regulatory Authorities in the Territory concerning the Combination Product and in order to provide BMS with an opportunity to be present at such meetings and to review and comment on such communications; provided , however , that in no event shall Gilead,

 

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after using reasonable efforts to provide BMS with an opportunity to be present at any such meeting or to review and comment on such communications, be required to postpone any such meeting to ensure that BMS attends such meeting or to postpone any such communication in order to ensure that BMS’ comments are received by Gilead in advance of its submission to Regulatory Authorities, as the case may be. In order to enhance the efficiency of the Member Parties’ coordination on regulatory matters concerning the Combination Product, and increase the likelihood that BMS will have a meaningful opportunity to participate in such activities, during the term of this Agreement, BMS will cause one of its employees with the necessary regulatory expertise and decision-making authority to be dedicated on a full-time basis to serving as a conduit for BMS’ participation in such activities. Gilead shall promptly forward to BMS in advance of any such meeting copies of all documents and other relevant information relating to such meeting. Notwithstanding anything contained in this Agreement to the contrary, (i) at any such meeting with, or any such communication to, the Regulatory Authorities in the Territory concerning the Combination Product, at which BMS and Gilead are present or in which both Member Parties participate, each Member Party shall take the lead on matters relating to its respective Single Agent Product(s) or Double Agent Product and (ii) at any such meeting with, or any such communication to, such Regulatory Authorities concerning the Combination Product, at which only one Member Party meets or in which communication only one Member Party participates (without the other Member Party’s presence or participation), such Member Party shall not engage in any substantive discussions pertaining to the other Member Party’s Single Agent Product(s) or Double Agent Product, as the case may be, including, without limitation, with respect to API consisting of EFV, TDF or FTC, as the case may be, as it relates to the Combination Product. Notwithstanding anything in this Section 3.4(b) to the contrary, this Section 3.4(b) shall not apply with respect to obtaining and maintaining the [ * ].

(c) Each Member Party shall promptly forward to the other Member Party any written communications received from representatives of the Regulatory Authorities relating to the Combination Product. BMS shall provide Gilead with full access to and copies (including electronic copies if requested) of the BMS Regulatory Documentation, including without limitation the NDA and NDS for Sustiva, as Gilead may reasonably request in connection with (and solely for the purpose of) the performance of its duties under this Section 3.4. Notwithstanding anything in this Section 3.4(c) to the contrary, this Section 3.4(c) shall not apply with respect to obtaining and maintaining the [ * ].

(d) Nothing in this Section 3.4 shall prohibit or restrict either Member Party from communicating with the Regulatory Authorities on matters relating to the Exploitation of any of its respective Single Agent Product(s), Double Agent Product or other pharmaceutical products. Each Member Party shall promptly notify the other Member Party of any label change for the first Member Party’s respective Single Agent Product(s) or Double Agent Product that may result in a label change for the Combination Product. If any communications from Regulatory Authorities regarding potential label changes for the Combination Product are reasonably expected to lead to a label change for a Member Party’s Single Agent Product or Double Agent Product, then, notwithstanding anything in this Agreement to the contrary, the affected Member Party shall take the lead in dealing with the Regulatory Authorities on such matter.

 

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3.5 Performance; Subcontracting . Gilead and BMS each shall perform its respective Development Activities in material compliance with GCP, GLP, and GMP, in each case to the extent applicable, and the requirements of Applicable Law, and so long as there is a Development Plan in effect, shall use Commercially Reasonable Efforts to perform its Development Activities under the Development Plan efficiently and expeditiously, subject to the Development Budget. Either Member Party may subcontract the performance of its respective Development Activities; provided , however , that the subcontracting Member Party shall oversee the performance by its subcontractors of the subcontracted Development Activities in a manner that would be reasonably expected to result in their timely and successful completion and shall remain responsible for the performance of such Development Activities in accordance with this Agreement and the Development Plan.

3.6 Records .

(a) Maintenance of Records . Gilead and BMS each shall severally (in accordance with their respective allocations of responsibilities with respect to Project Activities) maintain, or cause to be maintained, all Combination Product Regulatory Documentation and final supporting records and documentation therefor (but not draft records or documentation therefor except as otherwise required by Applicable Law), in sufficient detail and in material compliance with GCP, GLP, and GMP, in each case to the extent applicable. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development Activities in a manner appropriate for any regulatory purpose and, when applicable, for use in connection with Patent filings, prosecution and maintenance. Such documentation and records shall be retained for at least (i) three (3) years or (ii) such longer period as may be required by Applicable Law.

(b) Access to Records . Each Member Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any Combination Product Regulatory Documentation and final supporting records and documentation therefor generated or maintained by the other Member Party, for use by the receiving Member Party solely in connection with the performance of its Development Activities in a manner consistent with the Development Plan. Subject to the terms and conditions of this Section 3.6(b), each Member Party shall also have the right, during normal business hours and upon reasonable notice, to obtain from the other Member Party access to or copies of scientific, regulatory and technical records, documentation and data solely to the extent relating to the Combination Product or such other Member Party’s Single Agent Product(s) and/or Double Agent Product, as the case may be, and solely to the extent (i) necessary in order for the receiving Member Party to perform its obligations with respect to Development Activities in a manner consistent with the Development Plan, (ii) necessary for the receiving Member Party to confirm compliance with and/or to comply with GLP, GCP and GMP (to the extent applicable), and other Applicable Law, as it relates to Project Activities, and/or (iii) necessary to enable the receiving Member Party to conduct reasonable diligence on matters potentially giving rise to liability on the part of the JV and/or such receiving Member Party, or to conduct a defense of itself and/or the JV with respect to any such liability, if and to the extent that a fact, circumstance or event has arisen that gives the receiving Member Party a reasonable basis to believe that it or the JV has or may incur such liability, in each case for use by the receiving Member Party for the purpose set forth in clause

 

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(i), (ii) or (iii) above, as the case may be. Clause (iii) of the immediately preceding sentence shall not require any Party to provide such data, documentation or records in the event that the Parties’ interests in such matter are or may be [ * ], in which case [ * ], shall apply. Each such request shall be made in writing and shall state the reason(s) therefor (each a “Development Record Request”). The Member Party from which such records, documentation or data are requested shall have the right to raise reasonable objections in writing in response to such Development Record Request, including, without limitation, based on such Member Party’s interests in protecting from disclosure to the requesting Member Party trade secrets or other competitive business information. Upon any such objection being asserted, the Member Parties shall promptly confer in an attempt to address each Member Party’s concerns and reach a resolution with respect to the matter, and in the event that the Member Parties are unable to agree upon a mutually agreeable resolution, either Member Party shall have the right to refer the matter to the JDC. In the event that any such dispute is ultimately [ * ] determine as a threshold matter whether and to what extent one or more criteria set forth in clauses (i), (ii) and/or (iii) above have been satisfied by the requesting Member Party, and, if so, shall make a determination with respect to whether and to what extent the disclosure of such information shall be required by [ * ]. In making such determination, [ * ] to the facts and arguments set forth in the Development Record Request and the other Member Party’s written response thereto, and (y) shall have the right to require the receiving Member Party to abide by terms and conditions for the handling, use and non-disclosure (either within such Member Party’s organization and/or to Third Parties) of such information as may be reasonable under the circumstances. Except as provided in this Section 3.6, a Member Party shall not have the right to obtain from the other Member Party access to or copies of the other Member Party’s records, documentation and data described above, unless otherwise expressly permitted pursuant to this Agreement or the other Member Party gives its consent in its sole discretion.

3.7 Updates to Development Plan and Development Budget . Gilead shall prepare and submit to each of the JDC and JFC (i) not less than [ * ] prior to the start of each Calendar Year, a proposed update to the Development Plan and the Development Budget for such Calendar Year and (ii) not less than [ * ] prior to the start of each Calendar Year, a preliminary update to such Development Budget (which may address budget issues at a general level, may be incomplete and is subject to change). In addition, either Member Party, directly or through its representatives on the JDC, may propose updates to the Development Plan and the Development Budget to the JDC from time to time as appropriate in light of changed circumstances. Such changes and updates shall be subject to approval by the JDC as set forth in Section 2.7(f), with annual updates to be approved at least [ * ] prior to the start of such Calendar Year. If an annual or interim update to the Development Plan or the Development Budget is not approved by the JDC, then, subject to Sections 2.2(v) and 2.9 as applicable, the Development Plan or Development Budget, as the case may be, shall continue in effect as approved and most recently updated pursuant to this Section 3.7. Updated Development Plans shall not cover items other than those included in the initial Development Plan unless mutually agreed by the Member Parties.

3.8 Development Expenses . [ * ] shall be [ * ] responsible for all costs that it incurs (a) in its sole discretion, in connection with the [ * ] or (b) in the performance of [ * ]

 

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Development Activities as set out in the Development Plan attached hereto as Annex B, [ * ] attached hereto as Annex V. The Parties agree that the JV shall bear all JV Expenses incurred by Gilead or BMS in connection with the performance of its respective Development Activities to the extent meeting all of the following criteria (“Authorized Development Expenses”): (i) such Development Activities are conducted pursuant to the Development Plan and are within an area of responsibility for the relevant Member Party listed in the Development Budget as being chargeable to the JV; (ii) the total expenses for that area of responsibility for that Member Party for the relevant period to the extent that they do not exceed the corresponding budgeted amount for that area in that period by more than [ * ] unless approved by the JDC; (iii) the expenses are external, out-of-pocket costs of Gilead or BMS, without any markup; and (iv) the expenses are not [ * ] costs of [ * ] referred to in the [ * ].

3.9 Reports . Gilead and BMS shall each present to the other, at a meeting of the JDC at least once per Calendar Quarter until the first anniversary of the Launch of the Combination Product in the United States, and, thereafter, at a meeting of the JDC, at least semiannually, a report (oral and written, which written report shall not be required to contain more detail than that typically included in an executive summary) describing (i) the Development Activities it has performed, or caused to be performed, since the preceding meeting at which such a report was presented (or, in the case of the first meeting of the JDC, prior to such meeting) and on a Calendar Year-to date basis, evaluating the work performed in relation to the goals and timeline of the Development Plan, (ii) its Development Activities in process and the future activities it expects to initiate during the then-current Calendar Year, as compared to the Development Plan, and (iii) in the case of the written report the Authorized Development Expenses incurred, and expected to be incurred, by such Member Party for the then-current Calendar Year, as compared to the Development Budget. In addition, Gilead and BMS shall report promptly to the JDC through their respective committee members any material developments with respect to Development Activities that they are responsible for performing under the Development Plan. Notwithstanding anything contained in this Section 3.9 to the contrary, each Member Party’s reporting obligations under this Section 3.9 shall automatically be deemed to terminate with respect to any period in which there is not then in effect a Development Plan and Development Budget.

3.10 New Products . During the period from the Effective Date through the [ * ] anniversary of the Effective Date, the Member Parties agree to use commercially reasonable efforts to evaluate and pursue an arrangement with each other for the co-development and co-commercialization of a [ * ] product comprising [ * ]; provided , however , that the Member Parties may terminate such efforts by mutual written agreement if they determine that the proposed product is not commercially or technically feasible, with such agreement to terminate not to be unreasonably withheld. In furtherance of the foregoing, notwithstanding anything in this Agreement to the contrary, during the period from the Effective Date through the [ * ] anniversary of the Effective Date (a) Gilead shall not (and shall cause its Affiliates not to) [ * ] an [ * ] with any [ * ] for [ * ] within the Territory of any [ * ] that contains [ * ] with a [ * ] that is (i) [ * ] to that Third Party and (ii) [ * ] in the Territory as of [ * ], and (b) BMS shall not (and shall cause its Affiliates not to) [ * ] an [ * ] with any [ * ] for [ * ] within the Territory of any [ * ] that contains [ * ] in combination with [ * ] that are (i) proprietary to that Third Party and (ii) [ * ] in the Territory as of [ * ].

 

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3.11 Publication .

(a) Either Member Party shall have the right to publish or present data and findings resulting from Project Activities, including, without limitation, Co-Funded Clinical Trials, subject to the right of objection or demand for modification by the other Member Party in the interest of (i) protecting the Confidential Information of such other Member Party, (ii) preserving the intellectual property rights of such other Member Party or the JV, and/or (iii) assuring that the publication or presentation presents such data and findings in a fair, accurate and balanced manner in accordance with ethical, medical and/or scientific standards. During the term of this Agreement, each Member Party shall provide to the other Member Party’s representatives on the JDC for review copies of all academic, scientific and medical publications and presentations specifically relating to the Combination Product (or otherwise relating to the combined use of EFV, FTC and TDF) that the Member Party proposes to submit for publication or presentation and that result from Project Activities; provided , however , that notwithstanding anything contained in this Section 3.11 to the contrary, the terms and conditions of this Section 3.11 shall not apply to any publications and presentations resulting directly or indirectly from Study 934. Review of such publications and presentations shall be conducted only for purposes of considering compliance with the standards set forth in clauses (i), (ii) and (iii) above (the “Publication Standards”) and shall consider whether any portion of any such publication or presentation should be modified or deleted in order to conform to the Publication Standards. In addition, in the case of any such publication or presentation resulting from a Co-Funded Clinical Trial, the Member Party that proposes to submit such publication or presentation shall have the right to do so only if the other Member Party agrees that such publication or presentation, as may be modified, conforms to the Publication Standards, which agreement shall not be unreasonably withheld or delayed. Such Member Party shall consider in good faith any comments provided to it by such other Member Party with respect to such publication or presentation, including, without limitation, any comments of a scientific or medical nature. In the case of any such publication or presentation resulting from other Project Activities, the other Member Party shall have a right to comment on such publication or presentation, provided that the Member Party proposing such publication or presentation shall be under no obligation to accept such comments (except to the extent necessary to preserve the intellectual property rights of such other Member Party or the JV) and shall be free to publish or present, as the case may be. Written copies of each proposed publication or presentation required to be provided for review shall be provided to the other Member Party’s representatives on the JDC no later than [ * ] before submission for publication or presentation, except that (A) in the case of an abstract, a copy of the abstract shall be provided as soon as reasonably practicable in advance of the submission of such abstract to a Third Party (which period may be less than [ * ] and (B) if the deadline for submission of such publication or presentation is less than [ * ] from the date of completion of that publication or presentation, copies will be provided as soon as reasonably practicable in advance of such submission deadline. In the case of any proposed publication or presentation of a Member Party that is required to be reviewed by the other Member Party, in the event that the Member Parties fail to reach agreement, if applicable, on such publication or presentation by the conclusion of

 

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the applicable review period, and as a result there is a dispute between the Member Parties with respect to such publication or presentation, such dispute may be referred by either Member Party to the JDC. The Member Parties shall comply in any publications made pursuant to this Section 3.11 with standard academic practice regarding authorship of scientific publications and recognition of contribution of parties. For the avoidance of doubt, nothing contained in this Section 3.11 shall alter or affect a Member Party’s confidentiality obligations pursuant to Section 12.

(b) Subject to compliance with Section 3.11(a), nothing in this Agreement shall restrict either Member Party from providing information on Co-Funded Clinical Trials conducted by the other Member Party to any Clinical Trials Registry or Clinical Trials Results Database, in accordance with Applicable Law and industry practice. For purposes of this Section 3.11(b), (i) “Clinical Trial Registry” means any listing of Clinical Trials which have been initiated, whether maintained by the U.S. federal government ( e.g., www.clinicaltrials.org ), or an independent organization (e.g., PhRMA or Rx&D) and (ii) “Clinical Trials Results Database” means any database which provides access to Clinical Trial results to physicians, patients and the general public, whether maintained by any government, Regulatory Authority or independent organization (e.g., PhRMA or Rx&D).

3.12 Certain Inspections . Each Member Party shall involve the other Member Party, to the extent feasible, in its GCP, GLP and GMP audit process for any facilities used in the performance of Development Activities for the Combination Product (including the facilities of any subcontractors to the extent permitted pursuant to the terms of the applicable subcontract or otherwise permitted by the applicable subcontractor) and shall consider in good faith any issues concerning such compliance or any safety and efficacy issues with respect to the Combination Product or the active pharmaceutical ingredient(s) of the other Member Party’s Single Agent Product(s) or Double Agent Product, as applicable, that are raised by the other Member Party on a reasonable basis as a result of such audits. Each Member Party shall also have the right, during normal business hours and upon reasonable notice, to inspect the other Member Party’s facilities (or the facilities of any subcontractor to the extent permitted pursuant to the terms of the applicable subcontract or otherwise permitted by the applicable subcontractor), used in the performance of Development Activities for the Combination Product, if the Member Party desiring such inspection has a reasonable basis on which to raise in good faith any such compliance, safety or efficacy issues apart from the aforementioned audit inspections. Any audit referred to in this Section 3.12 shall be subject to reasonable restrictions on access to confidential information and trade secrets by the inspecting Member Party to the extent such confidential information and trade secrets are not expressly required to be disclosed by such Member Party to the other Member Party pursuant to this Agreement.

3.13 Medical Affairs and Medical Communications .

(a) Gilead and BMS shall determine independently how to utilize and deploy their respective medical science liaisons for activities relating to the Combination Product. The JDC shall develop and approve presentation materials for use by each Member Party’s medical science liaisons when engaging in activities to support the Combination Product, and the medical science liaisons shall use only such approved presentation materials in such

 

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activities. The JDC shall develop, and the Member Parties shall implement, procedures to coordinate the training of each Member Party’s medical science liaisons on any approved presentation materials.

(b) The JDC shall develop guidelines and procedures for determining and providing appropriate responses to medical inquiries about the Combination Product, including assigning responsibilities for medical communications. The Parties shall develop a set of standard response documents for the Member Parties to use in responding to medical inquiries about the Combination Product, as follows: (i) each Member Party shall develop standard response documents relating to their respective Single Agent Product(s) and Double Agent Product as incorporated in the Combination Product, and (ii) Gilead shall develop draft standard response documents relating to the Combination Product as a whole (substantially incorporating that developed by each Member Party for its Single Agent Product(s) and/or Double Agent Product), for review, comment and approval by the JDC.

SECTION 4.

MANUFACTURING AND SUPPLY

4.1 Clinical Supply . Gilead shall Manufacture or have Manufactured through a subcontractor, on behalf of the JV, clinical supplies of the Combination Product in such quantities as may be needed for the clinical trials and studies required to obtain Approvals of the Combination Product in each country in the Territory. In connection with such Manufacture, Gilead and BMS each shall donate to the JV quantities of FTC and TDF, in the case of Gilead, and EFV, in the case of BMS. Each Member Party’s Cost of Goods of such supply, as well as Gilead’s Cost of Goods for Manufacture of the clinical supplies of the Combination Product, shall not be chargeable to the JV.

4.2 Commercial Supply .

(a) The initial Development Plan designates the initial commercial Supplier of the Combination Product, which Supplier shall be the source of Combination Product supply for purposes of the NDA filing and Launch in the United States. Within [ * ] after the Effective Date, the JCC shall determine the most cost-efficient manner in which to source the commercial supply of the Combination Product, including, without limitation, one or more alternate suppliers. Thereafter, during the term of this Agreement, the JCC shall review annually the appropriate source(s) of commercial supply of the Combination Product after Launch in the United States and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the JCC shall adopt if failure to do so would be likely to have a material adverse effect on the Combination Product business. If Gilead or BMS desires to be considered as a possible Supplier of the Combination Product, it shall submit a confidential written proposal to the JV for consideration by the JCC alongside written proposals submitted by recognized, reliable and sufficiently capitalized Third Parties and/or the supply terms pertaining to the initial Supplier. Any proposal submitted by a possible Supplier shall include an offer to perform any required tableting, blistering, packaging, labeling, analytical testing and storage activities with respect to commercial supplies of the Combination Product. The JCC shall select a Person to supply the

 

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JV with commercial supplies of the Combination Product on the basis of price, quality, reliability, GMP compliance, security of supply and other relevant commercial considerations. If a Third Party is selected as a Supplier, the JCC shall designate a Member Party to manage the relationship with that Supplier. Any supply contract between the JV and Gilead or BMS as Supplier shall be negotiated on an arm’s-length basis and shall contain such terms and conditions as are customary in the pharmaceutical industry, modified as appropriate for the Combination Product. The Parties anticipate that, following the Amended Effective Date, the JV and Gilead will negotiate an amendment to that certain Product Supply Services Agreement entered into by the JV and Gilead as of May 24, 2006, as well as the related Quality Agreement, for the purpose of establishing commercial supply arrangements with respect to the Combination Product for Canada.

(b) The JCC, directly or through a designated Member Party, and in coordination with the JDC, shall monitor Manufacturing capacity of, and forecasts and orders for, the Combination Product submitted to the relevant Supplier(s) to ensure that adequate commercial supplies of the Combination Product will be available to meet the demand therefor as projected by the JCC in commercial unit volume forecasts. The JCC shall prepare [ * ] rolling unit volume forecasts at least [ * ] before the commencement of each forecast period, and shall update such unit volume forecasts on a [ * ] basis, or as the JCC deems necessary and appropriate.

(c) In connection with the Manufacture by the Supplier of the commercial supply of the Combination Product for the JV, Gilead and BMS each shall supply to the JV quantities of FTC and TDF, in the case of Gilead, and EFV, in the case of BMS, and in each case in the form of bulk active pharmaceutical ingredient, pursuant to and in accordance with their respective Supply Agreements. In consideration of such supply, the JV shall pay to Gilead and BMS, respectively, the Gilead Transfer Price and the BMS Transfer Price. The JDC shall monitor orders under the respective Supply Agreements to assure consistency in the quantities of FTC, TDF and EFV ordered by the JV thereunder.

SECTION 5.

COMMERCIALIZATION ACTIVITIES

5.1 Co-Promotion Obligations .

(a) Gilead and BMS each shall use Commercially Reasonable Efforts to perform in each country in the Territory the Commercialization Activities that such Member Party is required to perform under the applicable Commercialization Plan in accordance with the applicable Commercialization Budget, for so long as there is a Commercialization Plan in effect. Each Member Party shall be required, during the Initial Launch Period under each such plan and (to the extent there is a [ * ] applicable thereto) the applicable Subsequent Launch Period, to [ * ] per Calendar Quarter, and take the other actions, applicable to it as specified in the relevant Commercialization Plan. Subject to Section [2.11, no minimum Detail requirements] shall apply (i) during a Subsequent Launch Period unless approved by the JEC or the applicable Commercialization Committee, as part of an update to a Commercialization Plan pursuant to Section 5.11(c), and (ii) after a Subsequent Launch Period unless approved by the Member

 

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Parties. Each Member Party shall be free to engage in [ * ], and to engage in [ * ] when there is no longer a Commercialization Plan in effect, in each case in its sole discretion.

(b) Gilead and BMS shall select independently the target prescribers to which each shall Promote the Combination Product.

(c) In accordance with Section 2.10(b), Gilead and BMS shall each cause its Field Force to use only the product labels and inserts approved by the applicable Regulatory Authority and, subject to Section 5.7, the Approved Marketing Materials in Promoting the Combination Product, and to make only such statements and claims regarding the Combination Product as are consistent with Applicable Law and product labels and inserts approved by the applicable Regulatory Authority. Gilead and BMS shall not provide or give access to samples of the Combination Product to health care practitioners or patients in connection with Promotion of the Combination Product.

(d) Gilead and BMS shall each Detail the Combination Product and perform its other Promotional activities under this Agreement in the Territory in strict adherence to regulatory and professional requirements, and to all Applicable Law, including, to the extent applicable, the Canadian Act and the U.S. Act and applicable regulations promulgated thereunder; the rules on promotion set out in Health Canada guidelines and policies; the Code of Advertising Acceptance of the Pharmaceutical Advertising Advisory Board (PAAB); the Rx&D Code of Conduct for Canada’s research-based pharmaceutical companies; the Canadian Medical Association Policy on Physicians and the Pharmaceutical Industry; the FDA Guidance for Industry-Supported Scientific and Educational Activities; the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals; the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers; the American Medical Association Guidelines on Gifts to Physicians from Industry; the Pharmaceutical Marketing Research Group Guidelines on market research activities; the Prescription Drug Marketing Act of 1987, as amended (“PDMA”); and all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations, including but not limited to the Medicare and State Health Programs Anti-Fraud and Abuse Amendments of the Social Security Act, the “Safe Harbor Regulations” found at 42 C.F.R. §1001.952 et seq. As among the Parties, each Member Party shall treat its sales representatives engaged in Detailing the Combination Product as its (or its Affiliate’s) own employees for all purposes, including, without limitation, federal, state, provincial and local tax and employment laws.

(e) Within [ * ] after the end of each Calendar Quarter (or part thereof) falling within (i) the Initial Launch Period for a country in the Territory, (ii) (to the extent there is a [ * ] applicable thereto) the Subsequent Launch Period in such country, or (iii) any period commencing after such Subsequent Launch Period if mutually agreed by the Member Parties pursuant to Section 2.11 (clauses (i), (ii) and (iii) being referred to herein collectively as the “Product Detail Period”), Gilead and BMS shall each furnish the other Parties with a written report, in the form set forth in Annex H attached hereto, setting out the number of Details that it has conducted during such Calendar Quarter (or part thereof) in such country. The number so reported shall be determined in accordance with applicable self-reporting procedures for details

 

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customarily employed by such Member Party in the Territory for other similarly detailed and similarly reported HIV products to the target health care audience, consistently applied.

(f) In each Calendar Year (or part thereof) falling within the Product Detail Period, subject to the terms of this Section 5.1(f), each Member Party shall [ * ] to conduct in each country in the Territory (x) the [ * ] for each Calendar Quarter (or part thereof) specified in the Commercialization Plan for such country (the [ * ]) and (y) the [ * ] for such Calendar Year (or part thereof) specified in such Commercialization Plan ( i.e ., the [ * ]) (the [ * ]). To the extent that the applicable Product Detail Period includes part but not all of a Calendar Quarter, then the [ * ] for such Calendar Quarter shall be [ * ]. If, in any Calendar Quarter during the applicable Calendar Year, the [ * ] of Details conducted by a Member Party [ * ] for such country for such Calendar Quarter (such [ * ] being a [ * ]), such Member Party may [ * ] of Details it conducts [ * ], if any, during the [ * ], and in [ * ], in each case in order to [ * ] some or all of the [ * ]. Subject to Section 5.1(g), if, in any Calendar Year, the [ * ] of Details conducted by a Member Party [ * ] for such Calendar Year (such [ * ] being [ * ]), then notwithstanding anything in this Agreement to the contrary, (i) the other Member Party shall [ * ], and (ii) any failure by a Member to comply with this Section 5.1(f) which results in such [ * ] shall not be subject to the [ * ] For clarity, no [ * ]

(g) If, during any Calendar Quarter, a Member Party expects that it will experience a [ * ] with respect to a country in the Territory for the succeeding Calendar Quarter (or part thereof), it shall inform the other Member Party of the anticipated [ * ] by written notice as promptly as practicable but no later than the due date of the report referred to in Section 5.1(e). The other Member Party shall have the right to [ * ] in such country in such succeeding Calendar Quarter (or part thereof) by up to the anticipated [ * ] for such succeeding Calendar Quarter (or part thereof) by giving notice to the first Member Party of its intent to do so within [ * ] of receiving the notice. For the avoidance of doubt, if the other Member Party gives such notice and so [ * ], the first Member Party shall [ * ] to the other Member Party an amount equal to the product of [ * ] multiplied by the [ * ] multiplied by the [ * ] In any such case, the [ * ] of the [ * ], if any, with respect to such country under [ * ] shall be [ * ]

5.2 Distribution Obligations .

(a) Gilead shall have the sole responsibility and right to fill orders with respect to the Combination Product on behalf of the JV; provided, however, in the case of Combination Product to be distributed in Canada, Gilead shall [ * ] the Combination Product as set forth in that certain distribution and supply agreement (“Canada Distribution and Supply Agreement”) to be entered into by the Parties within [ * ] the Amended Effective Date substantially on the terms outlined in Annex P2. Annex P2 also sets forth, solely for illustrative purposes, a schematic outlining the contemplated manufacturing/commercial structure in Canada. The Parties expressly agree that on all Combination Product label, packaging and promotional materials in Canada the [ * ]

(b) If for any reason BMS receives sales orders for the Combination Product, it shall promptly forward such order to Gilead. An order for the Combination Product may be rejected by Gilead only if such rejection is commercially reasonable under the

 

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circumstances. For each country in the Territory, the Commercialization Committee for such country shall determine how the JV shall respond to requests from individual patients who have or may obtain prescriptions for the Combination Product in such country but may be unable to afford it, and from health care providers on behalf of such patients, including, without limitation, establishing appropriate procedures and response times that shall apply in responding to such requests; provided , however , that the applicable Commercialization Committee shall structure the applicable program in a manner that will make evident to such health care providers and patients the participation of the JV (and, as appropriate, each of its Member Parties) in such program and shall ensure that the procedures and response times are no less favorable to patients than the most favorable of either Member Party’s patient assistance programs for its Single Agent Product(s) and/or Double Agent Product as of the Effective Date. The applicable Commercialization Committee shall review the arrangements for the patient assistance program annually and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the Commercialization Committee shall adopt if failure to do so would be likely to have a material adverse effect on the Combination Product business.

(c) Without limitation of the foregoing, Gilead shall perform all the functions of a distributor with respect to sales of the Combination Product on behalf of the JV, including, without limitation, inventory management and control, warehousing and distribution, invoicing, collection of sales proceeds, preparation of sales records and reports, customer relations and services, and handling of returns, in accordance with customary practice in the biopharmaceutical industry, pursuant to (i) in the case of the United States, a separate Services Agreement to be entered into by the Parties within [ * ] of the Effective Date substantially on the terms outlined in Annex P1, or (ii) in the case of Canada, pursuant to the Canada Distribution and Supply Agreement.

(d) Gilead’s relationships with wholesale distributors for the Combination Product shall be governed by inventory management agreements to reduce inventory fluctuations to the extent commercially feasible, and if such agreements do not also cover Gilead’s other products in the Field, they shall be commercially reasonable and [ * ] For any [ * ] the Combination Product or services or activities relating thereto, Gilead shall ensure either that (i) such [ * ] are [ * ] for [ * ] on a [ * ] as for [ * ] or (ii) if such [ * ] Gilead shall use Commercially Reasonable Efforts to keep inventory levels of the Combination Product at wholesale distributors at [ * ] subject to fluctuations expected during the Launch period for the Combination Product in each country in the Territory.

 

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5.3 Pricing of Combination Product .

A. In the United States .

The provisions of this Section 5.3A shall govern, and accordingly shall be construed to apply to, only matters relating to the pricing of the Combination Product in the United States, and not Canada.

(a) Gilead shall have sole responsibility to act as agent for selling the Combination Product on behalf of the JV at prices that [ * ] with the [ * ] (as defined below) made pursuant to the provisions of this Section 5.3A and the [ * ] set forth on Annex Q1 (the [ * ]).

(b) Gilead and BMS shall each appoint two (2) members of a pricing committee for the JV (the “US Pricing Committee”). One (1) representative from each Member Party (the “[ * ] Representative”) shall be an employee of that Member Party who is not at the time of his or her appointment, or at any time during his or her service on the US Pricing Committee, otherwise involved, directly or indirectly, in the [ * ] of such Member Party’s (or any of its Affiliates’) [ * ] (provided, that for purposes of this Section 5.3A, duties solely with respect to accounts receivable analysis, bookkeeping and accounting shall not, without more, be deemed involvement in [ * ]). Such representatives shall have skills reasonably appropriate to their responsibilities and functions as members of the US Pricing Committee. The other representative from each Member Party (the “[ * ] Representative”) shall be [ * ] for that Member Party. Furthermore, each Member Party covenants that, for [ * ] immediately after an individual’s service on the US Pricing Committee (or for such shorter period as he or she is employed by such Member Party or its Affiliate), he or she will not be assigned to a function or position that involves, directly or indirectly, the pricing of such Member Party’s (or any of its Affiliates’) [ * ] products. Each Member Party shall have the right to approve the other Member Party’s proposed [ * ] Representative and [ * ] Representative on the US Pricing Committee (or any replacement therefor), which approval shall not be unreasonably withheld. Subject to the preceding sentence, each Member Party shall have the right to replace its [ * ] Representative and/or [ * ] Representative from time to time during the term of this Agreement, provided that the composition of the US Pricing Committee as so changed meets the requirements set forth above in this Section 5.3A(b). For the avoidance of doubt, the US Pricing Committee is not an Operating Committee of the JV and, accordingly, references in this Agreement, the Operating Agreement and, if applicable, any Ancillary Agreement to an Operating Committee shall not apply to the US Pricing Committee. The US Pricing Committee may determine in its sole discretion to retain independent legal counsel, in which case the expenses of such counsel shall be deemed to be Authorized Other Expenses.

(c) Gilead and BMS shall each be responsible for the performance of its representatives on the US Pricing Committee and their compliance with the terms of this Section 5.3A and the [ * ] Any issue regarding the [ * ] of the US Pricing Committee shall be reviewed [ * ] Gilead and BMS shall each bear their own expenses related to the US Pricing Committee, including without limitation all expenses relating to the meetings of the US Pricing Committee, the participation of the Member Parties’ representatives in such meetings,

 

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communications with the other Member Party in connection with such meetings or matters within the authority of the US Pricing Committee, and travel to and from such meetings, and such expenses shall not be deemed JV Expenses or Authorized Other Expenses.

(d) The US Pricing Committee shall be responsible, on an ongoing basis, for [ * ] Gilead, as agent of the JV [ * ] (i) the [ * ] in accordance with this Section 5.3A and the [ * ] (the [ * ]) and (ii) any [ * ] as [ * ] according to the [ * ] with respect to [ * ] (as defined in the [ * ]) from the JV. The US Pricing Committee shall meet at least quarterly (which meeting may be conducted by telephone or videoconference equipment, so long as each attendee is able to hear the others), and as otherwise required from time to time, to [ * ] The [ * ] will serve as [ * ], as applicable, in [ * ] Gilead, as agent of the JV, and [ * ] Gilead, as agent of the JV, shall have no authority to [ * ], as the case may be, for [ * ]

(e) Should interpretation of the [ * ] become necessary, the [ * ] Representatives on the US Pricing Committee shall discuss the matter with the [ * ] Representatives and attempt to resolve the matter by consensus. In the event that a consensus cannot be reached, no [ * ] with respect to [ * ] and Gilead, as agent of the JV, shall not [ * ]

(f) The functional role of each representative on the US Pricing Committee shall be limited to:

coordinating with Gilead, as agent of the JV, to ascertain [ * ]

on an as-needed basis, providing the US Pricing Committee the [ * ] as the case may be;

only on an as-needed basis, and as specifically requested with respect to [ * ] providing the US Pricing Committee such other specifically limited [ * ] pertinent to [ * ] as the [ * ] Representatives shall agree is necessary and appropriate;

applying the [ * ] with respect to [ * ] and

ensuring that the [ * ] for the Combination Product, as [ * ] as the case may be, for [ * ]

(g) Either Member Party (the “Requesting Member”) may, upon written notice to the other Member Party, cause the Independent Accounting Expert (selected pursuant to Section 7.1(d)) to confirm the accuracy, with respect to any [ * ] of (i) any [ * ] and/or (ii) any [ * ] to the US Pricing Committee, including, without limitation, the [ * ] as the case may be. In such case, each Member Party and the US Pricing Committee shall cooperate with the Independent Accounting Expert and (upon the Independent Accounting Expert’s entry into an appropriate confidentiality agreement) provide him or her with the data necessary to make the requisite calculations. Further, upon the written request of either Member Party, the calculations of the Independent Accounting Expert shall be audited by a second Third Party mutually agreed by the Member Parties. The Independent Accounting Expert and the Third Party auditor, if any, shall notify the JEC of their respective determinations, which notifications shall not contain any information provided to such Independent Accounting Expert (and/or such Third Party auditor) by either Member Party. The calculations made by the Independent Accounting Expert pursuant to this Section 5.3A(g) shall be binding upon the US Pricing Committee and the Parties; provided , however , that in the event that a Third Party auditor identifies a discrepancy in the Independent Accounting Expert’s calculations, the Member Parties shall cause the Independent Accounting Expert and such Third Party auditor to confer and agree upon the final calculations and advise the Member Parties in writing of same,

 

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whereupon such final agreed calculations shall be binding on the Parties. The Requesting Member shall bear the fees and costs of the Independent Accounting Expert in connection with its confirmation of the accuracy of such determination and/or information, unless the Independent Accounting Expert finds a discrepancy equal to or greater than [ * ] therein, in which case the JV (in the case of a discrepancy in a [ * ] or the other Member Party (in the case of a discrepancy in [ * ] shall bear such fees and costs. Nothing in this Section 5.3A(g) shall be deemed to limit any remedy available to either Member Party in the event of a breach of any of the provisions of this Section 5.3A or the [ * ] by the other Member Party. Notwithstanding anything in this Agreement to the contrary, such breach shall not be subject to the cure provisions set forth in Section 14.4.

(h) All information provided to the US Pricing Committee (“US Pricing Information”) shall be considered Confidential Information of the disclosing Member Party and shall be used solely for the purpose of [ * ] and for no other purpose. For the avoidance of doubt, the exceptions to confidentiality set forth in Section 12.2 (other than in Sections 12.2(a) and (b)) shall not apply to US Pricing Information. Except as expressly permitted by the [ * ] US Pricing Information shall not be disclosed by the US Pricing Committee representatives except to counsel, the Independent Accounting Expert, or any Third Party auditor selected pursuant to Section 5.3A(g). All US Pricing Information shall be [ * ] maintained by the US Pricing Committee, which [ * ] shall not be accessible by Persons other than the members of the US Pricing Committee. Without limiting the foregoing, each of BMS and Gilead shall:

cause its representatives on the US Pricing Committee not to disclose to any other Person [ * ] and

not reference or use, directly or indirectly, any information from the US Pricing Committee [ * ]

(i) Prior to the Launch of the Combination Product in the United States and thereafter annually, the JEC shall review the [ * ] (as most recently modified pursuant to this Section 5.3A(i), if applicable) in light of the then-prevailing market conditions and JV marketing and sales strategies. If appropriate, the JEC shall recommend to the Member Parties changes to the [ * ] The JEC’s action or inaction under this Section 5.3A(i) shall not be subject to arbitration. If (and only if) Gilead and BMS mutually agree on any such changes proposed by the JEC, then the [ * ] as so changed shall be deemed to be the [ * ] hereunder.

(j) Gilead and BMS shall each retain sole discretion with respect to price-setting and discounts for its respective Single Agent Products and Double Agent Product, if any. Notwithstanding the foregoing, each Member Party covenants that it shall [ * ] and shall not directly or indirectly [ * ] solely or primarily for the purpose of [ * ]

B. In Canada .

The provisions of this Section 5.3B shall govern, and accordingly shall be construed to apply to, only matters relating to the pricing of the Combination Product in Canada, and not the United States.

(a) Gilead shall have sole responsibility to act as distributor for selling the Combination Product on behalf of the JV in Canada in all circumstances (whether such sales are private and cash sales or sales that are reimbursed by a public formulary) at prices that [ * ] with the [ * ]

 

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(b) [ * ] after the Amended Effective Date, the Member Parties shall, upon mutual agreement, designate [ * ] to be responsible on behalf of the JV, in each Jurisdiction and for [ * ] for [ * ] for the Combination Product and otherwise for obtaining and maintaining the [ * ]

(c) Gilead and BMS shall each appoint one (1) representative (a “Pricing Liaison”), who shall be an employee of that Member Party who is not at the time of his or her appointment, or at any time during his or her service as the Pricing Liaison, otherwise [ * ] (provided, that for purposes of this Section 5.3B, duties solely with respect to accounts receivable analysis, bookkeeping and accounting shall not, without more, be deemed involvement in pricing). Each such representative shall have skills reasonably appropriate to his or her [ * ] as Pricing Liaison. Furthermore, each Member Party covenants that, for [ * ] immediately after an individual’s service as Pricing Liaison (or for such shorter period as he or she is employed by such Member Party or its Affiliate), he or she will [ * ] Each Member Party shall have the right to approve the other Member Party’s proposed Pricing Liaison (or any replacement therefor), which approval shall not be unreasonably withheld. Subject to the preceding sentence, each Member Party shall have the right to replace its Pricing Liaison from time to time during the term of this Agreement, provided that the each new Pricing Liaison so designated meets the requirements set forth above in this Section 5.3B(c). For the avoidance of doubt, a representative on the [ * ] may also serve [ * ]

(d) Gilead and BMS shall each be responsible for the performance of its Pricing Liaison and his/her compliance with the terms of this Section 5.3B and the [ * ] Gilead and BMS shall each bear their own expenses related to its respective Pricing Liaison, and such expenses shall not be deemed JV Expenses or Authorized Other Expenses.

(e) The Pricing Liaisons shall be responsible, on an ongoing basis, for [ * ] All such communications shall be in a prescribed written form. Neither Pricing Liaison shall [ * ] In the [ * ] the Member Parties shall communicate with each other exclusively through their Pricing Liaisons and otherwise in the manner as provided in this Section 5.3B(e).

(f) All information provided to either Pricing Liaison (the “Canadian Pricing Information”) shall be considered Confidential Information of the disclosing Member Party and shall be used solely for the purpose of [ * ] For the avoidance of doubt, the exceptions to confidentiality set forth in Section 12.2 (other than in Sections 12.2(a) and (b)) shall not apply to the Canadian Pricing Information. Without limiting the foregoing, [ * ]

(g) Prior to the Launch of the Combination Product in Canada and thereafter [ * ] the JCOC shall review the Canadian [ * ] (as most recently modified pursuant to this Section 5.3B(g), if applicable) in light of the then-prevailing market conditions and JV marketing and sales strategies. If appropriate, the JCOC shall recommend to the JEC changes to the Canadian [ * ] and the JEC may recommend any such changes to the Member Parties. The [ * ] under this Section 5.3B(g) shall not be subject to arbitration. If (and only if) Gilead and BMS

 

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mutually agree on any such changes proposed by the JEC, then the Canadian [ * ] as so changed shall be deemed to be the [ * ] hereunder.

(h) The [ * ] shall use commercially reasonable efforts to obtain and maintain [ * ] as the case may be, pursuant to [ * ] the Canadian [ * ] With respect to each Jurisdiction or Canada (federally), as the case may be, the applicable [ * ] shall alone, to the exclusion of the other Party, [ * ] a [ * ] in any Jurisdiction or Canada (federally), as the case may be, shall be strictly consistent with the conditions under which [ * ] provided that the Party that is subject to such conditions has notified the [ * ] of such conditions in writing. In the event that any such agency requests, or a Party desires, any [ * ] from such conditions, such proposed [ * ] shall be treated as if it were a [ * ] made under [ * ] of the Canadian [ * ] and shall be agreed only if approved pursuant to such [ * ]

(i) Gilead, as distributor, shall be responsible for reporting the [ * ] of the Combination Product on behalf of the JV to the PMPRB. [ * ] alone, to the exclusion of [ * ] shall handle dealings with the PMPRB with respect to compliance with the rules, regulations and guidelines of the PMPRB; provided, however, that [ * ] shall provide to [ * ] a copy of the [ * ] for the Combination Product for review in advance of its [ * ] with the PMPRB. [ * ] shall promptly furnish [ * ] with a copy of all materials received from the PMPRB, together with all reports and other communications submitted by [ * ] to the PMPRB, in each case solely to the extent relating to the Combination Product. In addition, at least [ * ] Business Days prior to filing any semi-annual report with the PMPRB hereunder, [ * ] shall furnish [ * ] with a copy of such report.

(j) If applicable, BMS and Gilead shall each independently, acting on behalf of the JV, handle dealings with [ * ] with respect to the [ * ] in accordance with assignments, on a customer-by-customer basis, mutually agreed by the Parties in writing, such that one Party, and not both, will handle such dealings with a [ * ] Should circumstances warrant in the future, the Parties agree, prior to the commencement of [ * ] on the Combination Product to any [ * ] to negotiate in good faith, under guidance of counsel, to [ * ] to [ * ] in Canada. Any such dealings shall then be undertaken in accordance with the Canadian [ * ]

(k) Except as permitted by this Section 5.3B and the Canadian [ * ] the Parties shall not otherwise discuss, or exchange any confidential or competitively-sensitive information relating to [ * ] including any information or data relating to the [ * ] thereof. Further, for the avoidance of doubt, [ * ] for the purpose of, determining [ * ] pursuant to this Section 5.3B.

(l) Gilead and BMS shall each retain sole discretion with respect to [ * ] Notwithstanding the foregoing, each Member Party covenants that it shall [ * ] and shall not directly or indirectly [ * ] solely or primarily for the purpose of [ * ]

5.4 National Accounts in the United States . With respect to the United States, Gilead shall have sole responsibility to act as agent for conducting all pricing or reimbursement activities on behalf of the JV relating to publicly funded drug plans, private drug benefit plans, governmental organizations, AIDS Drug Assistance Programs, correctional facilities and

 

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systems, managed care organizations and all other national accounts in all payor segments in the United States, including without limitation contract strategy and contract creation. Such activities shall be further defined in the U.S. Commercialization Plan and shall comply with Section 5.3A and the [ * ] Except with respect to pricing activities, with respect to the United States, BMS shall share in the Commercialization Activities in correctional facilities and systems and other national accounts.

5.5 Performance; Subcontracting . Gilead and BMS each shall comply, and shall cause its Affiliates to comply, with all Applicable Laws, regulations and Approvals in conducting their respective Commercialization Activities. Either Member Party may subcontract the performance of Commercialization Activities allocated to it under the Commercialization Plans; provided , however , that the subcontracting Member Party shall oversee the performance by its subcontractors of such subcontracted Commercialization Activities in a manner that would be reasonably expected to result in their timely and successful completion and shall remain responsible for the performance of such Commercialization Activities in accordance with this Agreement and the Commercialization Plans; and, provided , further , that neither Gilead nor BMS may engage any subcontractor, including, without limitation, any contract sales organization, to perform any Details of the Combination Product.

5.6 Conflict Avoidance . Gilead and BMS each agrees to ensure that, during the Initial Launch Period in the United States, none of its Field Force employees who engages in the Marketing of the Combination Product in the United States shall also market in the United States [ * ] that is [ * ] in the United States as of the [ * ]

5.7 Marketing Materials .

(a) The JCC or JCOC, as applicable, shall develop and approve an initial set of advertising and promotional materials for the Combination Product for use in each country in the Territory. If the applicable Commercialization Committee cannot reach agreement with respect to such materials, the JEC shall attempt to resolve any disputed issues relating to the materials. In the event that a Commercialization Committee or, following a dispute within a Commercialization Committee, the JEC shall reach agreement with respect to such materials for a country (as modified from time to time pursuant to this Section 5.7, the “Approved Marketing Materials”), then subject to subparagraph (b) below, each Member Party shall use the Approved Marketing Materials (and only the Approved Marketing Materials, together with the product label and the package insert approved by the applicable Regulatory Authority) in Promoting the Combination Product in such country for at least the [ * ] following the Launch in such country. If each of the Commercialization Committee and the JEC is unable to reach agreement on such materials, then the Member Parties shall Promote the Combination Product in such country using only the product label and the package insert approved by the applicable Regulatory Authority for the Combination Product.

(b) Each Member Party may propose interim updates to the Approved Marketing Materials for each country in the Territory from time to time, independent of the annual reviews conducted pursuant to Section 5.7(c). The applicable Commercialization Committee shall be required to consider, and shall adopt, such updates only if they satisfy the

 

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following conditions: (i) the update is based on relevant new scientific, medical or clinical data, relevant new regulatory or legal developments, or changes to the label or package insert approved by the applicable Regulatory Authority for the Combination Product; and (ii) in the absence of such update, the use of the Approved Marketing Materials would not comply with Applicable Law (any update satisfying such conditions, a “Required Update”).

(c) Approximately [ * ] after the Launch in a country in the Territory, the JCC or JCOC, as applicable, shall review and, if appropriate, update the Approved Marketing Materials for such country, if any. Such updates shall include, at a minimum, any Required Updates. If such Commercialization Committee cannot reach agreement on a Required Update proposed by a Member Party, then the matter shall be subject to dispute resolution under Section 2.9. In the event that neither the applicable Commercialization Committee nor the JEC is able to reach agreement on a proposed Required Update, and after [ * ] relating to Required Updates, each Member Party may elect upon written notice to the other Member Party to Promote the Combination Product in such country using either (i) only the product label and the package insert approved by the applicable Regulatory Authority or (ii) the Approved Marketing Materials as modified to reflect any Required Updates [ * ]

(d) In connection with the review conducted pursuant to Section 5.7(c), such Commercialization Committee may make other appropriate changes arising from business or other considerations (each, an “Optional Update”) as proposed by a Member Party. In the event that such Commercialization Committee cannot reach agreement on any proposed Optional Update to the Approved Marketing Materials for a country in the Territory, then the dispute shall be subject to dispute resolution under Section 2.9; provided , however , that [ * ] In the event that neither the applicable Commercialization Committee nor the JEC is able to reach agreement on a proposed Optional Update, each Member Party may elect upon written notice to the other Member Party to Promote the Combination Product in such country using either (i) only the product label and the package insert approved by the applicable Regulatory Authority or (ii) the Approved Marketing Materials without such Optional Update.

(e) After the review conducted pursuant to Section 5.7(c), the applicable Commercialization Committee shall review the most recent Revised Marketing Materials on an annual basis, and shall make Required Updates and consider any Optional Updates proposed by a Member Party. Any disputes within such Commercialization Committee relating to such updates shall be resolved using the procedures set forth in Sections 5.7(c) and 5.7(d).

(f) The JV shall own all rights, title and interest in and to such Approved Marketing Materials. Notwithstanding anything in this Agreement to the contrary, neither Member Party shall use in the Promotion of the Combination Product in a country in the Territory materials other than the product label and inserts approved by the applicable Regulatory Authority and the Approved Marketing Materials for such country. The JCC or JCOC, as applicable, shall select for the Marketing of the Combination Product in each country in the Territory an advertising agency or agencies, and the JV shall retain such agency or agencies on commercially reasonable terms. The applicable Commercialization Committee shall also develop, implement and oversee an orderly, systematic process, involving representatives

 

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from the legal, medical and regulatory functions of the respective Member Parties, for the review and approval of all such advertising and promotional materials for use in a country. In any interactions with a Regulatory Authority, the allocation of the Member Parties’ rights and responsibilities shall be as set forth in Section 3.4.

(g) Without prejudice to the other provisions of this Section 5.7, with respect to Approved Marketing Materials for use in Canada, Gilead shall be responsible for obtaining and maintaining any governmental approvals required with respect to the use of such Approved Marketing Materials and, for the avoidance of doubt, shall have the right to file for routine renewal of any such approvals annually without further JCOC or JEC approval.

5.8 Development and Use of Trademarks . The applicable Commercialization Committee shall select all Combination Product Trademarks for use in each country in the Territory, which shall be owned by the JV. Subject to Applicable Law, the JV shall include a Trademark and the name of each of Gilead Parent and BMS Parent on the labeling, packaging and advertising materials for the Combination Product in the Territory. The JV shall comply with all notice and marking requirements of applicable intellectual property law for the protection and enforcement of the Trademarks of the JV, Gilead and BMS, unless such notice and marking requirements are not commercially reasonable under the circumstances.

5.9 Insurance . The Member Parties agree that the JV will [ * ] Further, neither Member Party shall have any obligation to [ * ] In the event that either Member Party elects to [ * ] arising out of the Exploitation of the Combination Product, the Member Party [ * ] shall have the sole right to [ * ] For the avoidance of doubt, nothing contained in this Section 5.9 is intended, or shall be construed, to limit a Member Party’s (or the JV’s) indemnity obligations pursuant to Section 13.

5.10 Records .

(a) Maintenance of Records . Gilead and BMS each shall severally (in accordance with their respective allocations of responsibility with respect to Project Activities) maintain and retain, or cause to be maintained and retained, final records (but not draft records or documents except as otherwise required by Applicable Law) of its respective Commercialization Activities covered in the Commercialization Plans for at least (i) three (3) years or (ii) such longer period as may be required by Applicable Law.

(b) Access to Records . Subject to this Section 5.10(b), each Member Party shall have the right, with respect to records maintained by the other Member Party of such other Member Party’s Commercialization Activities covered in the Commercialization Plans, during normal business hours and upon reasonable notice, to inspect and copy any such records solely to the extent relating to the Combination Product and solely to the extent (i) necessary in order for the receiving Member Party to perform its obligations with respect to Commercialization Activities in a manner consistent with the applicable Commercialization Plan, (ii) necessary for the receiving Member Party to confirm compliance with and/or to comply with GLP, GCP and GMP (to the extent applicable), and other Applicable Law, as it relates to Project Activities, and/or (iii) necessary to enable the receiving Member Party to conduct

 

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reasonable diligence on matters potentially giving rise to liability on the part of the JV and/or such receiving Member Party, or to conduct a defense of itself and/or the JV with respect to any such liability, if and to the extent that a fact, circumstance or event has arisen that gives the receiving Member Party a reasonable basis to believe that it or the JV has or may incur such liability, in each case for use by the receiving Member Party for the purpose set forth in clause (i), (ii) or (iii) above, as the case may be. Clause (iii) of the immediately preceding sentence shall not require any Party to provide such data, documentation or records in the event that the Parties’ interests in such matter are or may be [ * ] in which case [ * ] shall apply. Each such request shall be made in writing and shall state the reason(s) therefore (each a “Commercial Record Request”). The Member Party from which such records, documentation or data are requested shall have the right to raise reasonable objections in writing in response to such Commercial Record Request, including, without limitation, based on such Member Party’s interests in protecting from disclosure to the requesting Member Party trade secrets or other competitive business information. Upon any such objection being asserted, the Member Parties shall promptly confer in an attempt to address each Member Party’s concerns and reach a resolution with respect to the matter, and in the event that the Member Parties are unable to agree upon a mutually agreeable resolution, either Member Party shall have the right to refer the matter to the applicable Commercialization Committee. In the event that any such dispute is ultimately [ * ] shall determine as a threshold matter whether and to what extent one or more criteria set forth in clauses (i), (ii) and/or (iii) above have been satisfied by the requesting Member Party, and, if so, shall make a determination with respect to whether and to what extent the disclosure of such information shall be required, by [ * ] In making such determination, [ * ] to the facts and arguments set forth in the Commercial Record Request and the other Member Party’s written response thereto, and (y) have the right to require the receiving Member Party to abide by terms and conditions for the handling, use and non-disclosure (either within such Member Party’s organization and/or to Third Parties) of such information as may be reasonable under the circumstances. Except as provided in this Section 5.10, a Member Party shall not have the right to obtain from the other Member Party access to or copies of the other Member Party’s records, documentation and data described above, unless otherwise expressly permitted pursuant to this Agreement or the other Member Party gives its consent in its sole discretion. Notwithstanding the foregoing, neither Member Party shall have any obligation to (and, with respect to pricing and discounting matters as set forth in Section 5.3A, neither Member Party shall) provide to the other Member Party any such information to the extent it relates to price setting and discounting, or inventory management agreements, or which such first Member Party is restricted from disclosing pursuant to Applicable Law or confidentiality or other contractual arrangements with Third Parties.

5.11 Commercialization Plans and Budgets .

(a) The Commercialization Plan for a country in the Territory shall cover only activities for commercialization of the Combination Product in such country that shall be conducted by a single Member Party or that must be coordinated between the Member Parties, which activities shall conform to the Collaboration Principles and the provisions of this Section 5.

 

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(b) The initial U.S. Commercialization Plan attached hereto as Annex C covers the period from the Effective Date through the Initial Launch Period for the United States (the “U.S. Commercialization Plan”). The initial Canadian Commercialization Plan attached hereto as Annex U covers the period from the Amended Effective Date through the Initial Launch Period for Canada (the “Canadian Commercialization Plan” and together with the U.S. Commercialization Plan, the “Commercialization Plans”). Each Commercialization Plan and any update thereto shall contain a budget for each Member Party’s out-of-pocket expenses for such Member Party’s activities set forth therein (respectively, the “U.S. Commercialization Budget” and “Canadian Commercialization Budget;” together, the “Commercialization Budgets”). The initial Commercialization Plan for each country covers (i) the [ * ] by each Member Party in [ * ] for the Initial Launch Period, (ii) [ * ] for the Combination Product in such country for the Initial Launch Period, and (iii) certain other Marketing and other commercialization activities for the Combination Product that are required to be conducted in such country by a single Member Party or that must be coordinated between the Member Parties. Updates of a Commercialization Plan shall not cover or include any activities not covered by the applicable initial Commercialization Plan unless mutually agreed by the Member Parties

(c) The responsible Member Party (as determined below) shall prepare and submit to each of the JCC or JCOC, as applicable, and JFC (i) not less than [ * ] prior to the start of each Calendar Year, any proposed update to a Commercialization Plan and a Commercialization Budget for such Calendar Year and (ii) not less than [ * ] prior to the start of each Calendar Year, a preliminary update to such Commercialization Budget (which may address budget issues at a general level, may be incomplete and is subject to change). Following review, discussion and revision of such proposed update, the JCC or JCOC, as applicable, shall vote upon such update at least [ * ] prior to the start of the applicable Calendar Year. BMS shall prepare the first such annual update; thereafter, such responsibility shall rotate between BMS and Gilead on a year-to-year basis, on the same annual schedule as for the first update, through the Calendar Year in which the Subsequent Launch Period for such country ends (or for such longer period as may be agreed by the Member Parties). In addition, either Member Party, directly or through its representatives on the JCC or JCOC, as the case may be, may propose interim updates to a Commercialization Plan and a Commercialization Budget to the JCC or JCOC from time to time as appropriate in light of changed circumstances. Such annual and interim updates for periods through the Calendar Year containing the end of the Subsequent Launch Period for such country shall be approved by the JCC as set forth in Section 2.4(b)(ii) or by the JCOC as set forth in Section 2.5(b)(ii), as applicable. Subject to Sections 2.2(vi) and 2.11, if a proposed update to the Commercialization Plan or Commercialization Budget is not approved by the JEC, then such Commercialization Plan or Commercialization Budget, as the case may be, shall continue in effect as approved and most recently updated pursuant to this Section 5.11(c).

5.12 Commercialization Expenses . The Parties agree that the JV shall bear all JV Expenses incurred by each of Gilead and BMS in connection with the performance of its respective Commercialization Activities with respect to a country in the Territory to the extent that they meet all of the following criteria (“Authorized Commercialization Expenses”): (a) such Commercialization Activities are covered in and consistent with the Commercialization Plan for such country and are within an area of responsibility for the relevant Member Party listed in the

 

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applicable Commercialization Budget as being chargeable to the JV; (b) the total expenses for that Member Party’s designated activities under such Commercialization Plan for the relevant period do not exceed the aggregate amount set forth in the in the applicable Commercialization Budget for such activities in that period by more than [ * ] (c) the expenses are external, out-of-pocket costs of Gilead or BMS, without any markup, and not internal costs, including, without limitation, internal costs incurred in [ * ] and (d) the relevant Commercialization Activities are for the Marketing in such country of the Combination Product only and not for the Marketing of any other proprietary products of Gilead or BMS. Notwithstanding the limitation contained in clause (d) above, in the event that either Member Party reasonably believes that there are cost or other efficiencies that the JV can reasonably be expected to achieve through one or both Member Parties’ conducting Commercialization Activities with respect to the Combination Product as part of, or in coordination with, activities being conducted by one or both Member Parties with respect to its or their Single Agent Product(s) and/or Double Agent Product, such Member Party(ies) may propose, by and through its applicable Commercialization Committee member(s), that such activities be coordinated and an appropriate and reasonable allocation of the related costs be made between the Combination Product, on the one hand, and such other product or products, on the other hand, and that the amount allocated to the Combination Product be treated as Authorized Commercialization Expenses (each such proposal, a “Cost Allocation Proposal”). If, and only to the extent that, such Cost Allocation Proposal is reviewed by the JFC and JCC or JCOC, as applicable, pursuant to Sections 0 and 0 or 2.5(b)(vii), respectively, and approved by the JEC pursuant to Section 2.2(ix) (with any modifications made by the JEC), the amount approved by the JEC for allocation to the Combination Product (any such approved costs, “Allocated Costs”) shall constitute Authorized Commercialization Expenses.

5.13 Reports . Gilead and BMS shall each present to the other, at a meeting of the applicable Commercialization Committee at least once per Calendar Quarter until the second anniversary of the Launch of the Combination Product in the applicable country in the Territory and, thereafter, at a meeting of the applicable Commercialization Committee at least semiannually, a report (oral and written, which written report shall not be required to contain more detail than that typically included in an executive summary) describing (i) the Commercialization Activities it has performed, or caused to be performed, since the preceding meeting at which such a report was presented (or, in the case of the first meeting of the applicable Commercialization Committee, prior to such meeting) and on a Calendar Year-to-date basis, evaluating the work performed in relation to the goals and timeline of each Commercialization Plan, (ii) its Commercialization Activities in process and the future activities it expects to initiate during the then-current Calendar Year, as compared to each Commercialization Plan, and (iii) in the case of the written report the Authorized Commercialization Expenses incurred, and expected to be incurred, by such Member Party for the then-current Calendar Year, as compared to the applicable Commercialization Budget. In addition, Gilead and BMS shall report promptly to the JCC or JCOC through their respective committee members any material developments with respect to Commercialization Activities that they are responsible for performing under the Commercialization Plan. Notwithstanding anything contained in this Section 5.13 to the contrary, each Member Party’s reporting obligations under this Section 5.13 shall automatically be deemed to terminate with respect to any period in which there is not then in effect a Commercialization Plan and/or a Commercialization Budget.

 

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SECTION 6.

LICENSE GRANTS

6.1 Technology Licenses by Member Parties to the JV .

(a) Subject to the terms and conditions of this Agreement, Gilead hereby grants to the JV a sole, royalty-free license (which license shall be exclusive as to BMS, its Affiliates and all Third Parties but not as to Gilead and its Affiliates), with the right to grant sublicenses solely as set forth in Sections 6.2(a), (c) and (e) or pursuant to Section 6.4, under the Gilead Technology only to Exploit the Combination Product (but not to make or have made the active pharmaceutical ingredients thereof or otherwise to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) worldwide.

(b) Subject to the terms and conditions of this Agreement, BMS hereby grants to the JV a sole, royalty-free license (which license shall be exclusive as to Gilead, its Affiliates and all Third Parties but not as to BMS and its Affiliates), with the right to grant sublicenses solely as set forth in Sections 6.2(a), (c) and (e) or pursuant to Section 6.4, under the BMS Technology only to Exploit the Combination Product (but not to make or have made the active pharmaceutical ingredients thereof or otherwise to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) in the Applicable EFV Territory.

6.2 Licenses and Sublicenses by the JV to Member Parties . Subject to the terms and conditions of this Agreement, the JV hereby grants the following licenses and sublicenses:

(a) to Gilead, (1) a non-exclusive, royalty-free sublicense, without the right to grant further sublicenses under the license granted to the JV in Section 6.1(b), (2) a non-exclusive, royalty-free license, without the right to grant sublicenses, under the Joint Technology and Joint Inventions, and any and all rights, title and interest that the JV may have in and to any Gilead Core Improvement and Patents claiming such Improvement and (3) additionally, a perpetual, royalty-free, fully paid-up, irrevocable, exclusive (even as to the JV) license, with the right to grant sublicenses through multiple tiers, under any and all rights, title, and interest that the JV may have in and to any Gilead Core Improvement and Patents claiming such Improvement, in the case of clauses (1) and (2) only (i) to Exploit the Combination Product (but not to Exploit the EFV active pharmaceutical ingredient therein individually or in combination other than in the Combination Product) in the Territory; (ii) to conduct anywhere in the world Development Activities in support of Approvals for the Combination Product in the Territory; and (iii) to make and have made, and import into the Territory, Combination Product (but not to make or have made the EFV active pharmaceutical ingredient therein) for Exploitation in the Territory, in each case ((i), (ii) and (iii)) pursuant to and in accordance with this Agreement, including, without limitation, performance of Gilead’s obligations under the Development Plan

 

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and the Commercialization Plan, and, in the case of clause (3) only, to Exploit such Improvement worldwide only with respect to products containing TDF or FTC as an active pharmaceutical ingredient, whether alone or in combination with one or more other active pharmaceutical ingredients (excluding EFV and other proprietary BMS active pharmaceutical ingredients);

(b) to BMS, (1) a non-exclusive, royalty-free sublicense, without the right to grant further sublicenses under the license granted to the JV in Section 6.1(a), (2) a non-exclusive, royalty-free license, without the right to grant sublicenses, under the Joint Technology and Joint Inventions, and any and all rights, title, and interest that the JV may have in and to any BMS Core Improvement and Patents claiming such Improvement and (3) additionally, a perpetual, royalty-free, fully paid-up, irrevocable, exclusive (even as to the JV) license, with the right to grant sublicenses through multiple tiers, under any and all rights, title, and interest that the JV may have in and to any BMS Core Improvement and Patents claiming such Improvement, in the case of clauses (1) and (2) only (i) to Exploit the Combination Product (but not to Exploit the TDF or FTC active pharmaceutical ingredients therein individually or in combination other than in the Combination Product) in the Territory; (ii) to conduct anywhere in the world Development Activities in support of Approvals for the Combination Product in the Territory; and (iii) to make and have made, and import into the Territory, Combination Product (but not to make or have made the TDF or FTC active pharmaceutical ingredients therein) for Exploitation in the Territory, in each case ((i), (ii) and (iii)) pursuant to and in accordance with this Agreement, including, without limitation, performance of BMS’ obligations under the Development Plan and the Commercialization Plan, and, in the case of clause (3) only, to Exploit such Improvement in the EFV License Agreement Territory only with respect to products containing EFV as an active pharmaceutical ingredient, whether alone or in combination with one or more other active pharmaceutical ingredients (excluding TDF, FTC and other proprietary Gilead pharmaceutical ingredients);

(c) to each of Gilead and BMS, a perpetual, non-exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers, under the Joint Technology and Joint Inventions (including, without limitation, Joint Know-How consisting of Clinical Data and other Relevant Experience Information, CMC Data and Finished Product Manufacturing Data), only to Exploit on a worldwide basis (in the case of Gilead) or in the EFV License Agreement Territory (in the case of BMS), (i) such Member Party’s Single Agent Product(s) and Double Agent Product, as the case may be, and (ii) other pharmaceutical compounds and products (other than the Combination Product), in each case ((i) and (ii)) whether alone or in combination with other agents; and

(d) to Gilead, an exclusive, royalty-free, with the right to grant sublicenses through multiple tiers, under the license granted to the JV in Sections 6.1(a) and (b) and under the Joint Technology and Joint Inventions (including, without limitation, Joint Know-How consisting of Clinical Data and other Relevant Experience Information, CMC Data and Finished Product Manufacturing Data) and any and all rights, title and interest that the JV may have in and to any Gilead Core Improvement and Patents claiming such Improvement, (1) to Exploit the Combination Product (but not to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) worldwide (except in the United States, Canada and Europe), (2) to conduct anywhere in the world development

 

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activities in support of Approvals for the Combination Product worldwide (other than Approvals in the United States, Canada and Europe), and (3) to make and have made anywhere in the world, and import anywhere in the world, Combination Product (but not to make or have made the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) for Exploitation worldwide (other than Exploitation in the United States, Canada and Europe), with such license to continue in effect so long as, and only so long as, Gilead is not in material breach of the conditions set forth in the following clauses (i) through (v) of this Section 6.2(d), subject to the last sentence of this Section 6.2(d):

Gilead shall use all commercially reasonable efforts to obtain for BMS appropriate and legally permissible public recognition for BMS’ role in enabling access to the Combination Product in the Developing World, which may include any or all of the following, in order of preference: (A) inclusion of BMS as a licensor and, if applicable, manufacturer, on the packaging and label of Combination Product sold or provided for use in the Developing World, (B) acknowledgement of BMS as a licensor and, if applicable, manufacturer or supplier of EFV, in press releases and other public announcements relating to provision of Combination Product for the Developing World, and (C) acknowledgement of BMS as a licensor and, if applicable, manufacturer or supplier of EFV, in any websites maintained by or through the cooperation of Gilead specifically to promote or enable provision of Combination Product for the Developing World; provided , however , that the Parties acknowledge that Gilead cannot ensure that any required Third Party or Regulatory Authority consents or approvals for such recognition can be obtained.

Except as provided in Section 6.9(a), Gilead shall not cause the sale by the JV of the Combination Product for use or sale outside the Territory.

Without BMS’ prior written consent, not to be unreasonably withheld or delayed, Gilead shall not grant sublicenses under the license granted to it in this Section 6.2(d) to, or utilize for Manufacture of Combination Product, any Person other than one who has contracted for Manufacture and supply of tableted Combination Product with BMS, one of its Affiliates, or a joint venture or similar entity in which BMS has an ownership interest, or any Person acting on behalf of any of the foregoing.

In the event that Gilead Exploits the Combination Product outside the United States, Canada and Europe pursuant to the license granted to it in this Section 6.2(d), BMS agrees to perform any administrative or ministerial acts that may be reasonably necessary or useful in order to enable Gilead to satisfy its obligations under clauses (i) through (iii) above or to enable Gilead to exercise its rights under the license granted to it in this Section 6.2(d). Gilead agrees that, other than with BMS’ consent, BMS shall have no additional obligations, including, without limitation, any obligation to incur additional expenses or obligations, as a result of such Exploitation, other than the following: BMS’ obligations provided for in this Section 6.2(d); BMS’ obligations pursuant to Section 6.9(a), the last sentence of Section 6.9(b) and the last sentence of Section 6.11; and BMS’ obligations pursuant to Applicable Law and any separate agreements between the Member Parties (including, without limitation, if applicable, the BMS Supply Agreement).

Gilead shall cause its sublicensees, if any, under this Section 6.2(d) to comply with the obligations of Gilead under clauses (i) through (iv) above, and any failure on the part of any such sublicensee to comply in any material respect with any such obligation of Gilead shall be deemed to be a failure on the part of Gilead to comply in such respect with such obligation.

 

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If Gilead is in material breach of any of clauses (i) through (v) above, Gilead’s license under this Section 6.2(d) shall not terminate unless and until BMS has given notice to Gilead of such breach and such breach remains uncured for sixty (60) days after Gilead’s receipt of such notice or, if longer, such period as would reasonably be required to cure such breach provided that Gilead is using commercially reasonable efforts to effect such cure. For clarity, a material breach of clauses (i) through (v) above shall not give rise to any rights of cure or of termination of this Agreement pursuant to Section 14.4 of this Agreement. The Parties acknowledge and agree that the remedy of specific performance set forth in Section 14.4(d) shall be available with respect to any material breach by Gilead of its obligations under this Section 6.2(d) or any material breach by BMS of its obligations under Section 6.2(d)(iv), Section 6.9 or Section 6.11.

(e) The JV shall have the right, but not the obligation, to grant, under the licenses granted to the JV in Section 6.1, to Bristol-Myers Squibb Gilead Sciences And Merck, Sharp & Dohme Limited a royalty-free, exclusive sublicense, with the right to sublicense through multiple tiers of sublicensees to any shareholder thereof or its subcontractors (with the scope of each such sublicense to be limited to the performance of services on behalf of such licensee) to obtain, maintain and update approvals with respect to the Combination Product in Europe (but not to conduct development activities with respect to the Combination Product or to conduct regulatory activities with respect to the active pharmaceutical ingredients thereof individually or in combination (other than with respect to the Combination Product)).

6.3 Licenses and Rights of Reference Between Member Parties .

(a) Subject to the terms and conditions of this Agreement, Gilead hereby grants to BMS (1) a (A) non-exclusive Right of Reference in the EFV License Agreement Territory with respect to such Gilead Know-How as consists of Clinical Data and other Relevant Experience Information, and (B) non-exclusive, royalty-free, fully paid-up, irrevocable license, with the right to grant sublicenses through multiple tiers, to use such Gilead Know-How in the EFV License Agreement Territory, in each case ((A) and (B)) solely to the extent reasonably necessary to enable BMS to Exploit its Single Agent Product, whether alone or in combination with other agents (other than Gilead’s Single Agent Product(s) or Double Agent Product), in the EFV License Agreement Territory in a manner consistent with the labeling and Approved Marketing Materials for the Combination Product, and (2) a perpetual, royalty-free, fully paid-up, irrevocable, exclusive (even as to Gilead and its Affiliates) license, with the right to grant sublicenses through multiple tiers, under any and all rights, title, and interest that Gilead and its Affiliates may have in and to any BMS Core Improvement and Patents claiming such Improvement, to Exploit such Improvement in the EFV License Agreement Territory only with respect to products containing EFV as an active pharmaceutical ingredient, whether alone or in combination with one or more other active pharmaceutical ingredients (excluding TDF, FTC and other proprietary Gilead pharmaceutical ingredients). For clarity, Gilead shall not be required to transfer any Gilead Know-How to BMS pursuant to Section 6.3(a)(1).

(b) Subject to the terms and conditions of this Agreement, BMS hereby grants to Gilead (1) a (A) worldwide, non-exclusive Right of Reference with respect to such BMS Know-How as consists of Clinical Data and other Relevant Experience Information, and (B) worldwide, non-exclusive, royalty-free, fully paid-up, irrevocable license, with the right to grant sublicenses through multiple tiers, to use such BMS Know-How, in each case ((A) and

 

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(B)) solely to the extent reasonably necessary to enable Gilead to Exploit its Single Agent Products or Double Agent Product as applicable, whether alone or in combination with other agents (other than BMS’ Single Agent Product), in a manner consistent with the labeling and Approved Marketing Materials for the Combination Product, and (2) a perpetual, worldwide, royalty-free, fully paid-up, irrevocable, exclusive (even as to BMS and its Affiliates) license, with the right to grant sublicenses through multiple tiers, under any and all rights, title, and interest that BMS and its Affiliates may have in and to any Gilead Core Improvement and Patents claiming such Improvement, to Exploit such Improvement only with respect to products containing TDF or FTC as an active pharmaceutical ingredient, whether alone or in combination with one or more other active pharmaceutical ingredients (excluding EFV and other proprietary BMS active pharmaceutical ingredients). For clarity, BMS shall not be required to transfer any BMS Know-How to Gilead pursuant to Section 6.3(b)(1).

6.4 Rights of Reference to and from the JV and Related Matters .

(a) Subject to the terms and conditions of this Agreement, Gilead and BMS each hereby grants to the JV a non-exclusive Right of Reference in the Territory with regard to the Gilead Regulatory Documentation and the BMS Regulatory Documentation, respectively, for the purpose of the JV’s securing, maintaining and updating Approvals and agrees to provide a signed statement to that effect in accordance with 21 C.F.R. § 314.50(g)(3) or HPFB’s position on authorization to cross reference.

(b) Subject to the terms and conditions of this Agreement, the JV hereby grants to BMS a non-exclusive Right of Reference in the Territory with regard to the Combination Product Regulatory Documentation, for the purpose of BMS’ securing, maintaining and updating NDAs for Sustiva and any other of its products containing EFV, other than the Combination Product, and agrees to provide a signed statement to that effect in accordance with 21 C.F.R. § 314.50(g)(3) or HPFB’s position on authorization to cross reference.

(c) Subject to the terms and conditions of this Agreement, the JV hereby grants to Gilead a non-exclusive Right of Reference in the Territory with regard to the Combination Product Regulatory Documentation, for the purpose of Gilead’s securing, maintaining and updating NDAs for Viread, Emtriva, Truvada, and any other of its products containing either or both of TDF and FTC, other than the Combination Product, and agrees to provide a signed statement to that effect in accordance with 21 C.F.R. § 314.50(g)(3) or HPFB’s position on authorization to cross reference.

(d) For so long as the license granted to Gilead in Section 6.2(d) remains in effect, (i) the JV shall (and the Members agree to cause the JV to) cooperate with Gilead to make the Combination Product Regulatory Documentation available to Gilead (including potentially through filing of an sNDA to the NDA as needed to change the Combination Product label or, if applicable, qualify a different presentation of the Combination Product for export, or granting a Right of Reference thereto) for use in securing approvals from the FDA for export of the Combination Product and for securing approvals from other Regulatory Authorities for use and sale outside of the United States, Canada and Europe, (ii) BMS and the JV hereby grant to Gilead Rights of Reference, if any, in any country

 

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worldwide outside the Territory and Europe solely for purposes of filing for Approvals of the Combination Product in any such country, which Rights of Reference shall continue for so long as the license granted to Gilead in Section 6.2(d) remains in effect, and agree to perform any administrative or ministerial acts that may be reasonably necessary or useful in order to enable Gilead to avail itself of such Rights of Reference, and (iii) BMS and the JV shall permit Gilead or its designee to provide a copy of any or all of the Combination Product Regulatory Documentation or any data or information therein to Regulatory Authorities outside the Territory and Europe, shall permit Gilead to obtain and provide Certificates of Pharmaceutical Product for the Combination Product (as approved by the FDA or other Regulatory Authorities) for submissions to Regulatory Authorities outside of the Territory and Europe, and shall provide any documentation or consents necessary to effectuate such Rights of Reference or permit Gilead to take all the foregoing actions in this clause (ii) for the Combination Product Regulatory Documentation and such Combination Product Certificates of Pharmaceutical Product. For clarity, BMS’ grants of rights under clauses (ii) and (iii) above shall not be construed as BMS’ granting any right to Gilead under any or all BMS Technology anywhere outside the Applicable EFV Territory.

6.5 Other Sublicenses . In supply agreements with the Suppliers selected pursuant to Section 4.2, the JV shall have the right to grant such Suppliers a non-exclusive, royalty-free, worldwide sublicense, without right to sublicense, under the Joint Technology and the licenses granted to the JV in Sections 6.1(a) and 6.1(b), for the sole purpose of Manufacturing the Combination Product (but not the active pharmaceutical ingredients thereof), for supply to the JV.

6.6 Trademark Licenses by Member Parties to the JV .

(a) Subject to the terms and conditions of this Agreement, Gilead hereby grants to the JV a non-exclusive, royalty-free, fully paid-up, license, with right to sublicense through multiple tiers, to use in the Territory (i) the Trademarks listed on Annex F hereto (the “Gilead Licensed Trademarks”) for the sole purposes of Exploitation of the Combination Product (but not to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) in the Territory and (ii) Gilead Parent’s name and company logo/identifiers, for use in the name of the JV, and/or on product labeling, product packaging, and promotional materials for the Combination Product pursuant to Section 5.8.

(b) Subject to the terms and conditions of this Agreement, BMS hereby grants to the JV a non-exclusive, royalty-free, fully paid-up, license, without right to sublicense, to use in the Territory (i) the Trademarks listed on Annex G hereto (the “BMS Licensed Trademarks”) for the sole purposes of Exploitation of the Combination Product (but not to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) in the Territory and (ii) BMS Parent’s name and company logo/identifiers, for use in the name of the JV, and/or on product labeling, product packaging, and promotional materials for the Combination Product pursuant to Section 5.8.

 

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(c) Each of the Member Parties shall be responsible for determining and thereafter monitoring what steps, if any, it needs to take in order to satisfy itself that the JV’s use of its Trademarks (i.e. the Gilead Licensed Trademarks or the BMS Licensed Trademarks, as the case may be), meets the commercially reasonable high quality standards, specifications, and instructions submitted or approved by Gilead or BMS, respectively, in connection with this Agreement.

(d) Gilead and the JV hereby recognize BMS’ right, title, and interest in and to the BMS Licensed Trademarks. Gilead and the JV further recognize that this Agreement, or use of the BMS Licensed Trademarks in connection with this Agreement, in no way confers to Gilead or the JV any right, title, and interest in and to the BMS Licensed Trademarks or any other trademarks or intellectual property rights owned by BMS, except as may otherwise be expressly provided in this Agreement. BMS and the JV hereby recognize Gilead’s right, title, and interest in and to the Gilead Licensed Trademarks. BMS and the JV further recognize that this Agreement, or use of the Gilead Licensed Trademarks in connection with this Agreement, in no way confers to BMS or the JV any right, title, and interest in and to the Gilead Licensed Trademarks or any other trademarks or intellectual property rights owned by Gilead, except as may otherwise be expressly provided in this Agreement.

(e) The JV acknowledges that (i) the goodwill generated by the JV’s use of the Gilead Licensed Trademarks will inure solely to the benefit of Gilead; and (ii) the goodwill generated by the JV’s use of the BMS Licensed Trademarks will inure solely to the benefit of BMS.

6.7 Trademark License by the JV to Gilead .

(a) Subject to the terms and conditions of this Agreement, the JV hereby grants to Gilead a non-exclusive, royalty-free, fully paid-up license, in all countries and territories of the world excluding the United States, Canada and Europe, with the right to sublicense through multiple tiers, to use Combination Product Trademarks for the sole purpose of Exploitation of the Combination Product (but not to Exploit the active pharmaceutical ingredients thereof individually or in combination other than in the Combination Product) in such countries and territories; provided , however , that this license shall remain in effect only so long as Gilead’s license pursuant to Section 6.2(d) remains in effect.

(b) BMS and Gilead hereby recognize the JV’s right, title, and interest in and to the Combination Product Trademarks. BMS and Gilead further recognize that this Agreement, or use of the Combination Product Trademarks in connection with this Agreement, in no way confers on BMS or Gilead any right, title, and interest in and to the Combination Product Trademarks on any other trademarks or intellectual property rights owned by the JV, except as may otherwise be expressly provided in this Agreement.

(c) BMS and Gilead acknowledge that the goodwill generated by their use of the Combination Product Trademarks will inure solely to the benefit of the JV.

 

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6.8 Retained Rights . All license rights not specifically granted in this Section 6 are expressly reserved by each licensing Party. Any license granted in this Section 6 which is not sublicensable may be transferred or assigned by the licensee Party only in connection with a permitted assignment of this Agreement by such Party under Section 15.4.

6.9 Combination Product Sales for Outside the United States, Canada and Europe

(a) If so requested by Gilead, either or both of BMS and the JV (acting for these purposes through BMS representatives), as applicable, shall negotiate in good faith a commercially reasonable arrangement (taking into account relevant economic and market conditions in the relevant territories, e.g. should BMS become the supplier, a transfer price [ * ] of the Combination Product in territories where it would be supplied) to enable the supply of EFV active pharmaceutical ingredient for Manufacture of Combination Product (in the case of BMS, either Manufacturing or enabling a Third party to Manufacture such EFV active pharmaceutical ingredient) or of Combination Product (in the case of the JV), in each case sufficient to allow Gilead, its designee or the JV (as permitted under Section 6.9(b)), to sell or provide Combination Product for use both in the Developing World and in other territories outside the United States, Canada and Europe, to meet the anticipated demand therefor in such countries.

(b) If requested by Gilead, and as permitted by applicable laws, rules and regulations, and consented to by BMS (such consent not to be unreasonably withheld or delayed), the Parties shall cooperate to enable and cause the JV to make the Combination Product available for export to, and use and sale in, the Developing World, including, without limitation, any sales within the Territory of Combination Product only for export, use or sale in the Developing World. As part of these efforts, the Parties shall negotiate in good faith appropriate amendments to this Agreement and the Operating Agreement consistent with clauses (i) through (v) of Section 6.2(d) and Section 6.9(c).

(c) Other than payments in respect of any supply of EFV (if applicable) or Combination Product by BMS or the JV pursuant to Section 6.8(a), BMS and the JV shall not be entitled to any additional financial compensation, whether in the form of license fees, milestone payments, royalties or otherwise, either by reason of sales by the JV or other Persons authorized by Gilead, of Combination Product for use outside the United States, Canada and Europe or by reason of the JV’s grant of the license in Section 6.2(d).

6.10 Combination Product Sales for Europe . The Parties acknowledge and agree that the Combination Product shall be sold or otherwise commercially distributed in Europe only [ * ] to (and only if the [ * ] upon) one (1) or more [ * ] (and, if applicable, the [ * ] covering Europe, unless such sale or distribution is commenced only after a [ * ]

6.11 EFV License Agreement . Notwithstanding anything in this Agreement to the contrary, Gilead agrees to exercise the rights granted to it in Sections 6.2(d), 6.4(d) and 6.9(a) in the territories outside the EFV License Agreement Territory, only after reaching an agreement with the EFV Licensor if and as necessary for Gilead to avoid infringing or misappropriating the intellectual property rights of the EFV Licensor in such territories. If requested by Gilead, BMS shall cooperate with Gilead in its efforts to reach such an agreement.

 

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6.12 JV Obligations as Sublicensee . The JV shall comply with all provisions applicable to sublicensees set forth in the EFV License Agreement (in the form provided by BMS to Gilead pursuant to Section 13.2(c)) and in the license agreements delivered by Gilead to BMS pursuant to the third sentence of Section 13.3(c) (in the form so delivered), respectively, including without limitation any such provisions with respect to reporting of information, record keeping and access to records for audit by the upstream licensor (but excluding any payment obligations or other matters for which a Member Party is responsible under Section 7.2). Such obligations as of the Effective Date are more specifically identified in Annex O. With respect to [ * ] with [ * ] referred to in Annex O (the [ * ] shall use commercially reasonable efforts to [ * ] after the Effective Date, the [ * ] grant of a sublicense to the JV under this Agreement as required by [ * ] (which [ * ] shall be in form and substance reasonably acceptable to [ * ]).

SECTION 7.

PAYMENTS AND THIRD PARTY ROYALTIES

7.1 Payments to Member Parties .

(a) In consideration of the supply by Gilead and BMS to the JV of quantities of their respective active pharmaceutical ingredients for manufacture of non-clinical supply of the Combination Product pursuant to Section 4.2(c) and their respective Supply Agreements (and in consideration of the provision of certain services hereunder), and subject to adjustment pursuant to Section 7.1(d), the JV shall pay to Gilead the “Gilead Transfer Price” and to BMS Sub the “BMS Transfer Price” in accordance with this Section 7. For a given Calendar Year, pursuant to this Section 7.1, the JFC shall calculate (i) interim Gilead Transfer Prices per kilogram of TDF or FTC bulk active pharmaceutical ingredient respectively, i.e. the applicable Transfer Price in accordance with Annex K hereto per kilogram of bulk active pharmaceutical ingredient (each an “Interim Gilead Unit Transfer Price”) and (ii) an interim BMS Transfer Price per kilogram of EFV active pharmaceutical ingredient, i.e. the applicable Transfer Price in accordance with Annex K hereto per kilogram of EFV active pharmaceutical ingredient (the “Interim BMS Unit Transfer Price”), in each case based upon the respective Working Percentages calculated pursuant to Section 7.1(c)(i), the Estimated Net Selling Price of the Combination Product in the Territory determined by the JFC with respect to such Calendar Year pursuant to Section 7.1(c)(ii), and the relevant Target Yield for the active pharmaceutical ingredient calculated pursuant to Annex K hereto. The JFC shall then inform Gilead and BMS of their respective Interim Unit Transfer Prices pursuant to Section 7.1(c)(iii). Subject to the last sentence of Section 7.3(c), each of Gilead and BMS Sub shall use its then-current Interim Unit Transfer Price(s) in preparing an invoice for each shipment of bulk active pharmaceutical ingredients it makes pursuant to Section 4.2(c) and its Supply Agreement.

(b) The Actual Gilead Percentage and the Actual BMS Percentage for a particular Calendar Year shall be equal to one hundred percent (100%) multiplied by a fraction, the denominator of which is the sum of the Net Selling Prices of Truvada and Sustiva in the Territory during the relevant Calendar Year, and the numerator of which is:

for the Actual Gilead Percentage, the Net Selling Price of Truvada in the Territory during the relevant Calendar Year; and

 

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for the Actual BMS Percentage, the Net Selling Price of Sustiva in the Territory during the relevant Calendar Year;

provided , however , that, without limitation of the obligations of the Member Parties under Section 5.3A(j) or 5.3B(f), for purposes of calculating the numerator and denominator of such fraction for both the Actual Gilead Percentage and the Actual BMS Percentage, any [ * ] in the Net Selling Price of Sustiva or Truvada for the relevant Calendar Year that [ * ] for the Calendar Year [ * ] shall be [ * ] and any such [ * ] shall not be [ * ] In the event of a termination of this Agreement, the effective date of which falls on a date other than December 31 of a Calendar Year, the determination of the Actual Percentages shall be based on the period from January 1 of such Calendar Year through the effective date of termination, instead of the entire Calendar Year; and the provisions of this Agreement shall apply, mutatis mutandis , to such period.

(c) The JFC shall determine the Member Parties’ Interim Unit Transfer Prices for each Calendar Year using the Member Parties’ respective Working Percentages, the Estimated Net Selling Price and the Target Yield, as follows:

On or before [ * ] BMS and Gilead shall agree in writing on the Working BMS Percentage and the Working Gilead Percentage for Calendar Year 2005 (which shall be equal to their respective Actual Percentages for Calendar Year 2004 using the relevant data for Calendar Year 2004 inclusive). For each subsequent Calendar Year, the respective Working Percentages shall equal the Actual BMS Percentage and the Actual Gilead Percentage, respectively, for the immediately preceding Calendar Year; provided, however, that, with respect to any Calendar Year, pending determination of the Actual Percentages for the immediately preceding Calendar Year, the Working Percentages for such immediately preceding Calendar Year shall remain in effect until such time as the Actual Percentages for such immediately preceding Calendar Year have been determined. On or before [ * ] BMS and Gilead shall agree in writing on the Target Yields for each of EFV, TDF and FTC for the Calendar Year 2005. For each subsequent Calendar Year, the relevant Target Yields for EFV, TDF and FTC shall be calculated pursuant to Section 7.1(d)(ii) and Annex K.

No later than [ * ] of each subsequent Calendar Year, the JFC shall determine the estimated Net Selling Price for the Combination Product in the Territory for such Calendar Year using only historical data (such amount for each Calendar Year, the “Estimated Net Selling Price”).

Using the Member Parties’ respective Working Percentages, the Estimated Net Selling Price in the Territory and the Target Yield for such Calendar Year, the JFC shall calculate each Member Party’s Interim Unit Transfer Price(s), in accordance with Annex K and shall so notify the Member Parties in writing no later than [ * ] days after the first day of the applicable Calendar Year. From and after the date on which a Member Party receives a notice from the JFC with respect to such Member Party’s respective Interim Unit Transfer Price(s) with respect to such Calendar Year, such amounts shall then be used by the Member Parties in invoicing the JV for the Transfer Price for shipments of bulk active pharmaceutical ingredients pursuant to Section 4.2(c) and the applicable Supply Agreement in such Calendar Year. Notwithstanding the foregoing, on a Calendar Quarter basis, the JFC shall recalculate the respective Interim Unit Transfer Prices (each, a “Recalculated Transfer Price”) in accordance with Annex K within [ * ]

 

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after the end of [ * ] Such recalculation shall be made using the Working Percentages, Target Yield and updated Net Selling Prices as determined in Annex I for such [ * ] In the event that a particular Interim Unit Transfer Price is less than the Recalculated Transfer Price, the JV shall deliver a reconciliation statement to the applicable Member Party setting forth the difference in price multiplied by the quantity of active pharmaceutical ingredient the Member Party invoiced to the JV during such [ * ] In the event a particular Interim Unit Transfer Price is greater than the Recalculated Transfer Price, the JV shall deliver a reconciliation statement to the applicable Member Party setting forth the difference in price multiplied by the quantity of active pharmaceutical ingredient the Member Party invoiced to the JV during such [ * ] In each case, the relevant adjustment shall be addressed as part of the cash netting mechanism provided for in Section 4.1 of the Operating Agreement and shall be settled on the first Cash Netting Day following such recalculation. The Interim Unit Transfer Prices shall not be changed as a result of the recalculation mentioned above.

Following [ * ] the JV shall cause the Independent Accounting Expert to calculate (solely for planning, accounting and bookkeeping purposes of the Member Parties) the Actual Percentages for such [ * ] based on data as of [ * ] to be completed no later than [ * ] after [ * ] The Respective Percentages shall not be changed as a result of the recalculation mentioned above.

(d) Following the end of each Calendar Year, the JFC shall cause an independent Third Party accounting firm or consultant mutually agreed by the Member Parties (such agreed Third Party, the “Independent Accounting Expert”) to calculate the Actual Percentages for such Calendar Year and recalculate the Transfer Prices (using the Product Yields determined pursuant to Section 7.1(d)(ii) and actual Net Selling Price for the Combination Product determined pursuant to Section 7.1(d)(iii)) with respect to shipments of bulk active pharmaceutical ingredient made by the Member Parties in such Calendar Year pursuant to Section 4.2(c) and their respective Supply Agreements, as follows.

Within [ * ] following the end of each Calendar Year, each Member Party shall provide to the Independent Accounting Expert the data necessary in order to make the calculations required pursuant to this Section 7.1(d), which data is described in Annex N.

Within [ * ] following the end of each Calendar Year, the JFC shall (A) calculate the Product EFV Yield, Product FTC Yield, and Product TDF Yield, in each case based on Actual Yield, for the supply of Combination Product and (B) provide to the Independent Accounting Expert written confirmation of such calculations. Within [ * ] following the first full-scale commercial manufacturing run, the JFC shall determine a blended average of each of Product EFV Yield, Product FTC Yield and TDF Product Yield on a per weight and per unit basis and inform the Independent Accounting Expert thereof.

Within [ * ] following the end of each Calendar Year, the JV shall cause the Independent Accounting Expert to (A) calculate the actual Net Selling Prices of the Combination Product, Truvada and Sustiva for that Calendar Year, (B) calculate the Actual Gilead Percentage and the Actual BMS Percentage pursuant to Section 7.1(b) using the actual Net Selling Prices of the Combination Product, Truvada and Sustiva for that Calendar Year and (C) recalculate the Gilead Transfer Price and the BMS Transfer Prices for the bulk active pharmaceutical ingredient shipments during that Calendar Year pursuant to Section 7.1(a) in accordance with Annex K.

Within [ * ] following the end of each Calendar Year, on the basis of such the recalculated Transfer Prices (as notified to the JV by the Independent Accounting Expert), the JFC shall

 

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recalculate the amounts owed by the JV to the Member Parties with respect to shipments received by the JV in such Calendar Year pursuant to Section 4.2(c) and their respective Supply Agreements and provide to the Member Parties notice of the recalculated amounts (and the adjustments that will be required pursuant to this Section 7.1(d)(iv)). If the aggregate amount invoiced by a Member Party for Transfer Prices is greater than or less than the aggregate amount owed to such Member Party by the JV for such Transfer Prices, as recalculated pursuant to this Section 7.1(d), then the relevant adjustment shall be addressed as part of the cash netting mechanism provided for in Section 4.1 of the Operating Agreement and shall be settled on the first Cash Netting Day following such recalculation.

(e) The Independent Accounting Expert shall be bound by commercially reasonable written confidentiality and non-use obligations to the Member Parties. Such Independent Accounting Expert shall, upon the written request of either Member Party (the “Initiating Member”), audit the other Member Party to confirm the accuracy of the data provided to such Independent Accounting Expert by such other Member Party. Further, upon the written request of either Member Party, the calculations of the Independent Accounting Expert shall be audited by a second Third Party mutually agreed by the Member Parties. The Independent Accounting Expert and the Third Party auditor, if any, shall notify the Member Parties of their respective determinations; provided , however , that neither the Independent Accounting Expert nor any Third Party selected to audit the Independent Accounting Expert shall share with either Member Party any information provided to such Independent Accounting Expert (and/or such Third Party) by the other Member Party. The calculations made by the Independent Accounting Expert pursuant to this Section 7.1(e) shall be binding on the Parties; provided , however , that in the event that a Third Party auditor identifies a discrepancy in the Independent Accounting Expert’s calculations, the Member Parties shall cause the Independent Accounting Expert and such Third Party to confer and agree upon the final calculations and advise the Member Parties in writing of same, whereupon such final agreed calculations shall be binding on the Parties. The Initiating Member shall bear the fees and costs of the Independent Accounting Expert in connection with its confirmation of the accuracy of such data, unless the Independent Accounting Expert finds a discrepancy equal to or greater than [ * ] therein, in which case the other Member Party shall bear such fees and costs.

(f) For the purpose of making calculations under this Agreement that require conversion from Canadian dollars into U.S. dollars, the Member Parties shall convert Canadian Dollars into U.S. dollars according to the following rules:

For the purpose of calculating the Net Selling Price for the Combination Product as it relates to the applicable Transfer Price, during a given Calendar Year, in Canadian dollars, the applicable Member Party shall convert such Canadian dollars to US dollars using the applicable spot rate listed on [ * ] to be determined by the JFC, which date shall occur within [ * ] after the approval by the JEC of the annual update to the Canadian Commercialization Budget for such Calendar Year.

For all purposes other than calculating the Net Selling Price for the Combination Product as it relates to the applicable Transfer Price, including for calculating the Net Selling Price of Viread, Emtriva, Truvada and Sustiva sold in Canadian dollars and for calculating Authorized Expenses incurred in Canadian dollars, each Member Party shall, in a manner consistent with its then-

 

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current standard worldwide currency conversion methodology, convert the applicable amounts incurred or sold, as the case may be, in Canadian dollars into US dollars.

7.2 Royalty Payments to Third Parties . If a Third Party’s Patent is or would be infringed or a Third Party’s trade secrets are or would be misappropriated solely as a direct result of the incorporation of TDF, FTC or both TDF and FTC in the Combination Product, then Gilead shall be solely responsible for any Losses or royalty, license fee or other payment obligation to such Third Party (which shall not qualify as a JV Expense or Authorized Expense) in connection with such infringement or misappropriation, including, without limitation, its obligations pursuant to Section 11.4. If a Third Party’s Patent is or would be infringed or a Third Party’s trade secrets are or would be misappropriated solely as a direct result of the incorporation of EFV in the Combination Product, then BMS shall be solely responsible for any Losses or royalty, license fee or other payment obligation to such Third Party (which shall not qualify as a JV Expense or Authorized Expense) in connection with such infringement or misappropriation, including, without limitation, its obligations pursuant to Section 11.4. All other royalty, license fee or other payments by Gilead or BMS to Third Parties in connection with licenses under Third Party Patents or Third Party trade secrets which are reasonably necessary for the performance of the Member Parties’ obligations under this Agreement shall qualify as Authorized Commercialization Expenses.

7.3 Authorized Expenses; Mode and Timing of Payment .

(a) The JV shall bear all Authorized Expenses incurred by Gilead and BMS. Each Member Party shall calculate and invoice the JV for its respective Authorized Expenses incurred in each Calendar Quarter in sufficient time to ensure that the applicable invoice is received by the JV no later than the last day of the next Calendar Quarter (the “Final Invoice Date”). The JV shall not have any obligation to make payments to Gilead or BMS on account of any such expenses incurred in a given Calendar Quarter for which an invoice is not received by the Final Invoice Date.

(b) All payments by the JV to the Member Parties pursuant to Sections 7.3(a) and 14.6(b)(ii) and other payments to be made to Member Parties under this Agreement shall be made by wire transfer or electronic funds transfer of United States Dollars in the requisite amount to such bank account as each Member Party may designate from time to time by notice to the payor.

(c) Each Member Party shall calculate and invoice the JV at the time of shipment, for the Transfer Price for each shipment of bulk active pharmaceutical ingredient pursuant to Section 4.2(c) and the applicable Supply Agreement using the applicable Interim Unit Transfer Price. The JV shall pay to a Member Party any amounts owed to such Member Party (or, in the case of BMS, to BMS Sub) pursuant to Section 7.1(a) on the applicable Cash Netting Day as provided in Section 4.1 of the Operating Agreement. In the case of any shipment of bulk active pharmaceutical ingredient pursuant to the applicable Supply Agreement during the first Calendar Quarter of a given Calendar Year prior to the JFC giving notice of the applicable Interim Unit Transfer Price, the Member Party providing such shipment shall use the Interim Unit Transfer Price for the immediately preceding Calendar Year for purposes of invoicing such shipment, provided that upon the JFC’s determination of the new Interim Unit

 

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Transfer Price for the Calendar Year in which such shipment occurs pursuant to Section 7.1(d) and Annex K, the JV shall recalculate such invoices using such new Interim Transfer Price for such Calendar Year and at the time of payment shall issue to the applicable Member Party a reconciliation statement, with respect to such invoice to reconcile any differences between the original Transfer Price for such shipment and the Transfer Price for such shipment as calculated using such new Interim Unit Transfer Price.

(d) Interest shall accrue on delinquent payments from the date such payments are due at the lesser of (i) the prime rate of interest, as published in The Wall Street Journal (Eastern United States Edition), plus [ * ] basis points and (ii) the maximum rate of interest permissible under Applicable Law, taking into consideration any amounts deemed additional interest.

7.4 Taxes . The JV shall be responsible for all sales, use, excise, value added and similar taxes and charges, including Canadian GST and all provincial sales taxes imposed with respect to acquisition of product from a Member Party and/or payments by the JV to a Member Party pursuant to this Section 7, provided that each Member Party shall be responsible for any taxes (including any such taxes imposed by way of withholding) in the nature of income or franchise taxes or based on or measured by gross or net income imposed with respect to its income. The JV shall pay any and all withholding taxes or similar charges imposed by any governmental unit that are required to be withheld from any amounts due to a Member Party from the JV pursuant to this Section 7 to the proper taxing authority, and proof of payment of such taxes or charges shall be secured and sent to such Member Party as evidence of such payment. All amounts paid by the JV pursuant to the immediately preceding sentence with respect to taxes for which a Member Party is responsible pursuant to the first sentence of this Section 7.4 shall be paid for the account of such Member Party and deducted from the amounts due from the JV to such Member Party pursuant to this Section 7.

7.5 [ * ] In light of the expansion of this Agreement to cover Canada, [ * ]

SECTION 8.

FINANCIAL RECORDS

8.1 Financial Records . Gilead shall keep complete and accurate books and records on behalf of the JV pertaining to sales of the Combination Product, including, without limitation, books and records of the Net Sales of the Combination Product, in the detail required for the calculation on behalf of the JV of amounts payable by the JV under Section 7.1(a) and to identify the purchase order details for each customer to which it sells the Combination Product, or pertaining to Authorized Commercialization Expenses, Authorized Development Expenses or Authorized Other Expenses. Gilead shall retain such books and records for at least the latest of (a) three (3) years after the Calendar Quarter in which the relevant sale was made or the relevant expense was reimbursed pursuant to Section 7.3, (b) the expiration of the applicable statute of limitations for tax purposes (or any extension thereof) or (c) such longer period as may be required by Applicable Law. Gilead and BMS shall each keep all records of Authorized Commercialization Expenses, Authorized Development Expenses and Authorized Other Expenses that it incurs for at least the latest of (i) three (3) years after the Calendar Quarter in

 

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which it invoiced them to the JV, (ii) the expiration of the applicable statute of limitations for tax purposes (or any expiration thereof) or (iii) such longer period as may be required by Applicable Law. Gilead and BMS shall each keep documentation supporting [ * ] for at least (x) three (3) years after the Calendar Quarter in which such [ * ] occurred or (y) such longer period as may be required by Applicable Law.

8.2 Audit of Records . At the request of BMS or Gilead, as the case may be, the other Member Party shall permit an independent certified public accountant reasonably acceptable to the other Member Party, at reasonable times and upon reasonable notice, to examine the books and records maintained by the other Member Party (and, if applicable, the books and records maintained by Gilead on behalf of the JV) pursuant to Section 8.1 to verify any or all of the following: (a) the accuracy of the amounts invoiced by the other Member Party to the JV pursuant to Section 7.1 and (b) the Authorized Commercialization Expenses, Authorized Development Expenses and Authorized Other Expenses charged by the other Member to the JV, in each case only as to any period ending not more than three (3) years prior to the date of such request. Such Third Party accountant shall be bound by written commercially reasonable confidentiality and non-use obligations to the Member Parties. Each Member Party shall receive a copy of the Third Party accountant’s report of any such audit, which shall disclose only whether such amounts as invoiced or charged are correct or incorrect, and the amounts of any underpayments or overpayments; such report shall be Confidential Information of both Member Parties. Any discrepancy shall be rectified by a reconciliation payment made by the underpaying Party or the overpaid Party, as the case may be, within thirty (30) days after receipt of notice thereof. If such audit establishes that either the non-requesting Member Party or the JV made an error in invoicing or payment to the detriment of the requesting Member Party, in amount equal to or greater than [ * ] of the relevant amounts for the period under audit, then the out-of-pocket costs of such audit shall qualify as an Authorized Other Expense. In all other cases, the costs of such audit shall be borne solely by the requesting Member Party and shall not qualify as a JV Expense or an Authorized Expense. BMS and Gilead may each make audit requests under this Section 8.2 on its own behalf or on behalf of the JV.

8.3 Certain Reports . So that BMS may satisfy its internal reporting needs, Gilead shall provide to BMS, at the applicable times set forth in Annex M, the financial data described in that Annex.

SECTION 9.

ADVERSE EVENT AND OTHER INFORMATION EXCHANGE

9.1 Pharmacovigilance . For purposes of this Agreement, that certain Safety Data Exchange Agreement dated as of February 11, 2005, by and between BMS Parent and Gilead Parent shall constitute the “SDEA,” including with respect to the indemnification obligations set forth herein. Notwithstanding the foregoing or anything to the contrary in Section 15.14, the Parties acknowledge and agree that (a) Gilead Parent, BMS Parent and the JV are parties to that certain worldwide Safety Data Exchange Agreement dated as of [ * ] (b) nothing herein shall be construed to modify or amend such agreement or any of their obligations thereunder, and (c) such agreement does not constitute the SDEA hereunder.

 

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9.2 Material Communications . In addition to the notifications required by Section 3.9 and the SDEA, each Member Party shall promptly provide notice to the other Member Party of any material communications with any governmental agency concerning the safety of the Combination Product, including, without limitation, adverse drug reaction reports. Copies of all such material communications shall be attached to the applicable notice.

SECTION 10.

PRODUCT RECALL

10.1 Notification and Recall .

(a) In the event that any governmental agency or authority issues or requests a recall or market withdrawal or takes similar action in connection with the Combination Product, or in the event that either Member Party determines that a recall or market withdrawal of the Combination Product may be necessary or advisable, such Member Party shall advise the other Member Party thereof by telephone, within [ * ] Each Member Party shall also notify the other promptly in the event of (i) the issuance of a field alert from a Regulatory Authority or similar alert by such Member Party (in which case the Member Party issuing such field alert shall notify the other Member Party at the same time as the applicable governmental agency or authority), and (ii) any communication from any governmental agency or authority regarding a potential recall or market withdrawal of the Combination Product or any of such Member Party’s respective Single Agent Product or Double Agent Product.

(b) Within [ * ] of receipt of notice given pursuant to the first sentence of Section 10.1(a), the Member Parties’ shall cause their respective representatives from the business, medical, regulatory, quality assurance and legal functions (and any others deemed necessary by a Member Party) to convene an initial meeting to consider whether or not the JV should conduct a recall (except in the case of a government-mandated recall or market withdrawal), and such representatives shall thereafter make a recommendation to the Member Parties with respect to such determination, and, if there is a recommendation to recall the Combination Product, with respect to the timing of the recall; the breadth, extent and level of customer to which the recall shall reach; the strategies and notifications to be used; and other related issues. Neither Member Party shall unreasonably object to a recall requested by the other Member Party; and neither Member Party shall have any right to object to a recall requested by the other Member Party (i) for failure of the Combination Product to meet the specifications therefor, (ii) if there is a reasonable basis to conclude that material harm to patients may occur, or (iii) for the Manufacture of the Combination Product in a manner that does not comply with Applicable Law. Notwithstanding the foregoing, if a recall or market withdrawal is mandated by a governmental agency or authority, or a recall is proposed by a Member Party, on account of such Member Party’s Single Agent Product or Double Agent Product, then such Member Party may cause the JV (and, accordingly, Gilead shall take such action on behalf of the JV) to effectuate such recall on such reasonable terms as such Member Party determines, without the meeting described in the first sentence of this Section 10.1(b) and without any liability to the other Member Party or the JV (except for expenses described in Section 10.2 and indemnity amounts payable by a Party pursuant to Section 13.7).

 

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(c) The Member Parties may, for commercial reasons or otherwise, mutually determine to withdraw the Combination Product from the market. If the reason for market withdrawal relates to efficacy or safety, such withdrawal shall be treated as one mandated by a government agency or authority and be dealt with as provided in Section 10.1(b). In all other cases, the JV shall, upon receiving Regulatory Authority approval, cease selling the Combination Product; and the Member Parties shall mutually determine whether, and if so how, to recall any Combination Product already on the market.

(d) Nothing set forth in this Section 10.1 shall be construed as restricting the right of either Member Party to make a timely report of such matter to any government agency or take other action that it deems appropriate or required by Applicable Law.

10.2 Recall Expenses . The Member Parties shall bear the expenses of any recall of the Combination Product in proportion to their Respective Percentages, and their respective external, out-of-pocket costs of such recall (without any markup) shall qualify as an Authorized Other Expense; provided , however , that each Member Party shall bear the expenses of a recall incurred in a reasonable manner to the extent that such recall is (a) caused by such Member Party’s breach of its obligations under this Agreement or its Supply Agreement (or, if it is the Supplier, its supply contract referred to in Section 4.2) or its gross negligence or willful misconduct, or (b) otherwise occasioned solely by such Member Party’s Single Agent Product and/or Double Agent Product, as the case may be. Such expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Combination Product and the refund to consumers of amounts paid for the recalled Combination Product.

SECTION 11.

INTELLECTUAL PROPERTY RIGHTS

11.1 Ownership of Intellectual Property .

(a) Gilead Intellectual Property . Except as otherwise expressly provided in Sections 6.1(a), 6.3(a), 6.4(a) and 14.6, as among the Parties, Gilead shall own all right, title, and interest in and to the Gilead Patents, the Gilead Know-How, the Gilead Inventions, and the Gilead Regulatory Documentation. Gilead shall disclose, and shall cause its Affiliates to disclose, to BMS any BMS Core Improvement promptly after it is conceived, discovered, developed, or otherwise made.

(b) BMS Intellectual Property . Except as otherwise expressly provided in Sections 6.1(b), 6.3(b), 6.4(a), 6.4(d) and 14.6, as among the Parties, BMS shall own all right, title, and interest in and to the BMS Patents, the BMS Know-How, the BMS Inventions and the BMS Regulatory Documentation. BMS shall disclose, and shall cause its Affiliates to disclose, to Gilead any Gilead Core Improvement promptly after it is conceived, discovered, developed, or otherwise made.

(c) JV Intellectual Property . Except as otherwise expressly provided in Sections 6.2, 6.4(b), 6.4(c), 6.4(d) and 14.6, as among the Parties, the JV shall own all right, title and interest in and to the Joint Patents, Joint Know-How, Joint Inventions and Combination

 

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Product Regulatory Documentation. Except as otherwise expressly permitted by this Agreement, no Party, including, without limitation, the JV, shall license, assign, sell, convey or otherwise Exploit its rights in any Joint Patents, Joint Know-How, Joint Inventions or Combination Product Regulatory Documentation for any purpose. Each Member Party shall disclose to the other Member Party promptly in writing any and all Joint Inventions that are conceived, discovered, developed or otherwise made by or on behalf of such Member Party, and each of the Member Parties hereby assigns, and agrees to cause its employees and agents to assign to the JV, without payment of additional consideration, all of such Member Party’s rights, title and interest in and to such Joint Inventions.

11.2 Prosecution of Patents .

(a) Gilead Patents . Gilead shall have the sole right, at its sole cost and expense, to prepare, file, prosecute and maintain the Gilead Patents in the Territory. Gilead shall have sole discretion to determine which Gilead Patents, if any, shall be listed in the “Orange Book” [ * ] with respect to the Combination Product.

(b) BMS Patents . BMS shall have the sole right, at its sole cost and expense, to prepare, file, prosecute and maintain the BMS Patents in the Territory. BMS shall have the sole discretion to determine which BMS Patents, if any, shall be listed in the “Orange Book” [ * ] with respect to the Combination Product.

(c) Joint Patents .

A patent application for a Joint Patent claiming any Joint Invention shall be filed only with the mutual written agreement of the Member Parties, and solely in accordance with this Section 11.2(c). In the event that either Member Party desires to have filed a patent application for a Joint Patent claiming a Joint Invention, such Member Party shall propose such filing to the other Member Party, and representatives designated by each Member Party shall discuss and consider the matter. In the event that the Member Parties fail to reach written agreement that such patent application should be filed, neither Member Party, whether on behalf of itself, the JV or any Third Party, may file or cause to be filed such patent application.

In the event that the Member Parties mutually agree in writing pursuant to Section 11.2(c)(i) that a patent application for a Joint Patent claiming a Joint Invention should be filed, Gilead shall have the sole right and obligation to prepare, file, prosecute and maintain the Joint Patents in the name of the JV in such countries as the Member Parties shall determine, and the external, out-of-pocket costs, without any markup, with respect thereto shall be treated as Authorized Other Expenses. BMS shall cooperate fully in Gilead’s preparation, filing, prosecution, and maintenance of the Joint Patents (and in any other proceedings before a patent official or office with respect thereto). Such cooperation shall include, without limitation, (A) promptly executing all papers and instruments or requiring employees to execute such papers and instruments as reasonable and appropriate so as to enable Gilead to prepare, file, prosecute, and maintain the Joint Patents in any country; and (B) promptly informing Gilead of matters that may affect the preparation, filing, prosecution, or maintenance of any such Joint Patent, including, without limitation, providing a copy of any official correspondence received by BMS from a patent office in any country with respect to Joint Patents. Gilead shall keep BMS advised of the status

 

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of Joint Patent filings and upon request of BMS shall provide copies of any official correspondence or other documentation with respect to official actions and submissions relating to the prosecution or maintenance of such Joint Patents.

The Member Parties shall have the sole discretion to determine (by mutual agreement) which Joint Patents, if any, shall be listed in the “Orange Book” [ * ] with respect to the Combination Product.

11.3 Enforcement of Patents .

(a) Gilead Patents . As among the Parties, Gilead shall have the sole right and option, at its sole cost and expense, to respond to any Infringement (as defined below) with respect to any Gilead Patent by appropriate steps, including, without limitation, by filing an infringement suit or taking other similar action. Gilead shall also have the sole right and option not to take action to respond to any such Infringement (and in such event no other Party shall have the right to take any action to respond to any Infringement with respect to such Gilead Patent). At Gilead’s request, each of BMS and the JV shall, at such Party’s own expense, provide reasonable assistance to Gilead in connection with any such action to respond to Infringement, including, without limitation, providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining (and having the JV join) the action to the extent necessary to allow Gilead to maintain the action. For purposes of this Section 11.3, (i) “Infringement” shall mean (A) infringement or potential infringement of one (1) or more Gilead Patents and/or one (1) or more BMS Patents, as the case may be, by the actions of a Third Party in connection with a product (an “Infringing Combination Product”) containing, among its active pharmaceutical ingredients, all of TDF, FTC and EFV and/or (B) with respect to Canada, [ * ] with respect to the Combination Product and (ii) “other similar action” shall include, without limitation, responses to paragraph (iv) certification under the Drug Price Competition and Patent Restoration Act (also known as the Hatch-Waxman Act) (a “Paragraph (iv) Certification”) and actions under section 6 of the Patented Medicines (Notice of Compliance) Regulations (Canada) resulting from an attempt to market a Generic Version Combination Product. For the avoidance of doubt, the Parties acknowledge and agree that infringement of a Gilead Patent or a BMS Patent, as the case may be, other than by an Infringing Combination Product, is outside the scope of this Agreement and shall not create any rights or impose any obligations on the Parties hereunder, including any right or obligation to take actions to respond to such infringement.

(b) BMS Patents . As among the Parties, BMS shall have the sole right and option, at its sole cost and expense, to respond to any Infringement with respect to any BMS Patent by appropriate steps, including, without limitation, filing an infringement suit or taking other similar action. BMS shall also have the sole right and option not to take action to respond to any such Infringement (and in such event no other Party shall have the right to take any action to respond to any Infringement with respect to a BMS Patent). At the request of BMS, each of Gilead and the JV shall, at such Party’s own expense, provide reasonable assistance to BMS or the EFV Licensor as applicable, in connection with any such action to respond to Infringement including, without limitation, providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining (and having the JV join) the action to the extent necessary to allow BMS or the EFV Licensor to maintain the action.

 

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(c) Joint Patents . If either Member Party determines that any Joint Patent is being infringed by a Third Party’s activities, it shall notify the other Member Party in writing and provide it with any evidence of such infringement that is reasonably available. Gilead, on behalf of, and in the name of, the JV, shall have the first right and option to respond to any infringement with respect to any Joint Patent by appropriate steps, including without limitation, filing an infringement suit or taking other similar action, and shall notify BMS of, and consult with BMS from time to time regarding, any such suit or other action. If Gilead elects at its sole discretion not to take action to respond to any such infringement, then BMS, on behalf of, and in the name of, the JV, shall have the right and option to respond to such infringement by appropriate steps, including without limitation, filing an infringement suit or taking other similar action, and shall notify Gilead of, and consult with Gilead from time to time regarding, any such suit or other action. Without limiting the foregoing, in the event that Gilead (for itself or on behalf of the JV) receives a Paragraph (iv) Certification [ * ] with respect to the Combination Product, Gilead shall notify BMS within thirty (30) days after its receipt of such Paragraph (iv) Certification [ * ] whether or not Gilead has made the election described in the preceding sentence and, if Gilead elects not to take action to respond to any such infringement, or fails to notify BMS within such [ * ] period, then BMS shall have the rights described in the immediately preceding sentence. The Member Party not taking action to respond to the infringement shall provide reasonable assistance to the Member Party taking such action, including without limitation providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow the Member Party taking such action to maintain the action. Any amounts recovered by a Member Party pursuant to this Section 11.3(c), whether by settlement or judgment, shall be deemed to be recovered on behalf of (and shall be paid over to) the JV; and the reasonable out-of-pocket costs, including reasonable attorneys’ fees, without any markup, incurred by the Member Parties in making such recovery shall be treated as Authorized Other Expenses.

(d) Paragraph (iv) Certifications; [ * ] Each Member Party shall notify the other Member Party in writing within [ * ] of receiving any Paragraph (iv) Certification [ * ] with respect to the Combination Product, (in the case of BMS) Sustiva, or (in the case of Gilead) Viread, Emtriva or Truvada, as applicable.

11.4 Infringement of Third Party Rights . If a Third Party initiates a Proceeding against the JV or a Member Party alleging that the conduct of the Project Activities infringes or will infringe such Third Party’s Patent or misappropriates or will misappropriate such Third Party’s trade secrets, (a) if such Proceeding arises as a direct result of TDF, FTC or both TDF and FTC being incorporated in the Combination Product, in each case without reference to EFV, then Gilead shall defend and hold the JV and BMS harmless from and against such Proceeding and any Losses resulting from such Proceeding, and shall have the sole right and obligation to defend such Proceeding or to settle it ( e.g. , by obtaining a license from such Third Party) at Gilead’s sole cost (which shall not be deemed a JV Expense or Authorized Expense), and BMS shall reasonably cooperate at Gilead’s request and expense in such defense and/or settlement; (b) if such claim arises as a direct result of EFV being incorporated in the Combination Product, in each case without reference to TDF or FTC, then BMS shall defend and

 

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hold the JV and Gilead harmless from and against such Proceeding and any Losses resulting from such Proceeding, and shall have the sole right and obligation to defend such Proceeding or to settle it ( e.g ., by obtaining a license from such Third Party) at BMS’ sole cost (which shall not be deemed a JV Expense or Authorized Expense), and Gilead shall reasonably cooperate at BMS’ request and expense in such defense and/or settlement; and (c) in the event that neither clause (a) nor (b) applies, then the JEC shall determine whether to defend against such claim or to obtain a license from such Third Party, and if so, on what terms and conditions (which out-of-pocket costs, without any markup, shall be deemed Authorized Other Expenses), and which Member Party shall take such actions on behalf of the JV. The procedures set forth in Section 13.8 shall apply to indemnification of Member Parties under this Section 11.4.

11.5 Trademarks .

(a) Gilead Licensed Trademarks . Gilead shall have the sole right, at its sole cost and expense, to search, clear, file, register, prosecute, maintain and enforce the Gilead Licensed Trademarks in the Territory. Gilead shall have the sole right and option, at its sole cost and expense, to respond to any infringement with respect to any Gilead Licensed Trademark by appropriate steps, including, without limitation, by filing an infringement suit or taking other similar action. Gilead shall also have the sole right and option not to prosecute, maintain or enforce Gilead Licensed Trademarks or take action to respond to any such infringement.

(b) BMS Licensed Trademarks . BMS shall have the sole right, at its sole cost and expense, to search, clear, file, register, prosecute, maintain and enforce the BMS Licensed Trademarks in the Territory. BMS shall have the sole right and option, at its sole cost and expense, to respond to any infringement with respect to any BMS Licensed Trademark by appropriate steps, including, without limitation, by filing an infringement suit or taking other similar action. BMS shall also have the sole right and option not to prosecute, maintain or enforce BMS Licensed Trademarks or take action to respond to any such infringement.

(c) Combination Product Trademarks . Except as otherwise expressly provided in Section 6.7, the Parties agree that, as among themselves, the JV shall own all right, title and interest in and to the Combination Product Trademarks. Gilead shall be solely responsible for searching, clearing, filing, registering, prosecuting and maintaining the Combination Product Trademarks in the Territory in the name of the JV, the external out-of-pocket costs (without any markup) of which shall be treated as Authorized Other Expenses. If either Member Party has a reasonable basis to believe that a Third Party is or may be engaging in commercially significant infringement of any Combination Product Trademark, such Member Party shall notify the other Member Party in writing and provide it with any evidence of such infringement that is reasonably available. Gilead shall have the first right and option to respond to any infringement or potential infringement with respect to any Combination Product Trademark by appropriate steps, including, without limitation, filing an infringement suit or taking other similar action, and shall notify BMS of, and consult with BMS from time to time regarding, any such suit or other action. If Gilead elects at its sole discretion not to take action to respond to any such infringement or potential infringement within [ * ] of Gilead’s becoming aware of such infringement or potential infringement, then BMS shall have the right and option

 

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to respond to such infringement or potential infringement by appropriate steps, including, without limitation, filing an infringement suit or taking other similar action, and shall notify Gilead of, and consult with Gilead from time to time regarding, any such suit or other action. The Member Party not taking action to respond to the infringement or potential infringement shall provide reasonable assistance to the Member Party taking such action, including, without limitation, providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow the Member Party taking such action to maintain the action. Any amounts recovered by a Member Party pursuant to this Section 11.5(c), whether by settlement or judgment, shall be deemed to be recovered on behalf of (and shall be paid over to) the JV; and the reasonable out-of-pocket costs, including reasonable attorneys’ fees, without any markup, incurred by the Member Parties in making such recovery shall be treated as Authorized Other Expenses.

SECTION 12.

CONFIDENTIALITY

12.1 Treatment of Confidential Information . Except as provided in this Section 12, during the term of this Agreement and for [ * ] after this Agreement’s expiration or termination, each Party (the “Receiving Party”) (a) shall hold in strict confidence and shall not publish or otherwise disclose, directly or indirectly, to any Third Party any Confidential Information of another Party or its Affiliates (collectively, the “Disclosing Party”), (b) except as permitted pursuant to Section 12.7, shall not directly or indirectly use Confidential Information of a Disclosing Party for any purpose other than performance of its obligations or exercise of its rights under this Agreement, or as otherwise permitted under this Agreement, the Operating Agreement or any Ancillary Agreement, and (c) shall use the same level of effort to maintain the confidentiality of Confidential Information of a Disclosing Party as it uses for its own confidential or proprietary information, but in any event at least commercially reasonable efforts.

12.2 Permitted Disclosure . Each Party may disclose Confidential Information of a Disclosing Party to the extent that such disclosure is:

(a) Made only as required to specific persons or entities under applicable laws, rules, regulations or orders of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction; provided , however , that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to seek any available limitations on, exemptions from or protections available under such disclosure requirement and reasonably cooperate in any such efforts by the Disclosing Party; and provided further that if an exemption from such disclosure requirement is not obtained, the Confidential Information disclosed in response to such requirement shall be limited to that information which is legally required to be disclosed;

(b) Otherwise required by law, in the opinion of legal counsel to the Receiving Party as expressed in an opinion letter in form and substance reasonably satisfactory to the Disclosing Party, which shall be provided to the Disclosing Party at least two (2) Business Days prior to the Receiving Party’s disclosure of the Confidential Information pursuant to this Section 12.2(b);

 

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(c) Made as required by the applicable laws and regulations (including, without limitation, Regulation FD) relating to securities or rules of the National Association of Securities Dealers, the New York Stock Exchange, or any other applicable association governing the stock exchange on which a Member Party’s stock is listed, including without limitation filing of reports on Forms 10-K, 10-Q and 8-K with the U.S. Securities and Exchange Commission, in which case (i) the procedures set forth in Section 12.2(d) shall apply if Section 12.2(d) is also applicable to such filing and (ii) the procedures set forth in the proviso to Section 12.5(b) shall apply;

(d) Made in the form of a filing of a copy of this Agreement by Gilead or BMS (as the case may be) with the U.S. Securities and Exchange Commission to comply with Applicable Law, provided that such Member Party (i) requests confidential treatment of at least the commercial terms and material terms hereof to the extent such confidential treatment is reasonably available to such Member Party, and (ii) solicits the other Member Party’s comments on such request for confidential treatment, in which case the filing Member Party shall use commercially reasonable efforts to take into account the other Member Party’s reasonable comments on such request;

(e) Subject to Section 3.4, made by the Receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for any regulatory approvals or otherwise to comply with the requirements of Applicable Law; provided , however , that reasonable measures shall be taken to assure confidential treatment of such information;

(f) Made by the Receiving Party as necessary to file or prosecute patent applications, prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement;

(g) Made by the Receiving Party to its employees, Affiliates, independent contractors, legal counsel, consultants, auditors and advisors who are bound by confidentiality and non-use obligations no less protective than those in this Section 12 and who reasonably require such Confidential Information for the performance of such Member Party’s obligations or enforcement of such Member Party’s rights under this Agreement (including, without limitation, the matters described in Sections 12.2(a) through (j)); provided , however , that the Receiving Party shall remain responsible for any failure by any such Person to treat such Confidential Information as required by this Section 12;

(h) Made by the Receiving Party to its licensors of its respective Technology pursuant to contractual obligations to such licensors existing as of the Effective Date and under obligations of confidentiality and non-use no less protective than those in this Section 12; provided , however , that the Receiving Party shall remain responsible for any failure by any such Person to treat such Confidential Information as required by this Section 12;

 

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(i) Made by the Receiving Party as necessary for the filing of its tax returns or pursuant to any audit thereof; or

(j) As otherwise permitted pursuant to Section 12.5 and Section 12.7.

12.3 Confidential Information .

(a) Defined . “Confidential Information” of a Party shall mean the terms of this Agreement and all Information and Inventions provided by or on behalf of such Party to another Party (or, in the case of Section 5.3A, to the US Pricing Committee) either in connection with the discussions and negotiations pertaining to this Agreement (including under the Mutual Confidential Disclosure Agreement entered into by and between Bristol-Myers Squibb Company and Gilead Sciences, Inc. as of December 12, 2003) or in the course of performing this Agreement or the MTTA, including, without limitation: the material terms of this Agreement; data; knowledge; practices; processes; ideas; research plans; engineering designs and drawings; research data; manufacturing processes and techniques; scientific, manufacturing, marketing and business plans; and financial and personnel matters relating to the Disclosing Party or to its present or future products, sales, suppliers, customers, employees, investors or business. For the avoidance of doubt, Confidential Information shall include any and all information provided by one Party to another Party relating to the Combination Product or the first-mentioned Party’s Single Agent Product(s) or Double Agent Product, as applicable; provided , however , that information provided by one Party to another Party relating to Improvements to the Core Technology of such other Party shall be deemed Confidential Information of such other Party.

(b) Exclusions . Notwithstanding the foregoing, Information and Inventions of a Disclosing Party shall not be deemed Confidential Information with respect to a Receiving Party for purposes of this Agreement if it:

was already known to the Receiving Party or its Affiliates, other than under an obligation of confidentiality or non-use, at the time of disclosure to such Receiving Party;

was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to such Receiving Party;

became generally available or known, or otherwise became part of the public domain, after its disclosure to such Receiving Party through no fault of the Receiving Party or its Affiliates;

was disclosed to such Receiving Party or its Affiliates, other than under an obligation of confidentiality or non-use, by a Third Party who had no obligation to the Disclosing Party not to disclose such Information and Inventions to others; or

was independently discovered or developed by such Receiving Party or its Affiliates, as evidenced by their written records, without the use of Confidential Information belonging to the Disclosing Party.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of a Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of such Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of a Party merely because individual elements of such Confidential Information are in the public domain or in the possession of such Party unless the combination and its principles are in the public domain or in the possession of such Party.

 

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12.4 Use of Name . Subject to Sections 5.8, 6.7 and 12.5, no Member Party shall mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of another Party (or any abbreviation or adaptation thereof) in any publication, press release, promotional material or other form of publicity without the prior written approval of such other Member Party in each instance. For purposes of this Section 12.4, Approved Marketing Materials shall be deemed to have been approved by all of the Member Parties. The restrictions imposed by this Section shall not prohibit any Member Party from making any disclosure identifying another Party that is required by Applicable Law.

12.5 Publicity; Terms of Agreement .

(a) The Parties shall make a joint public announcement of the execution and delivery of this Agreement substantially in the form of the joint press release attached as Annex L hereto upon or after the Effective Date, and in the form of the joint press release attached as Annex W hereto upon or after the Amended Effective Date.

(b) After public disclosure of the joint press release pursuant to Section 12.5(a), if either Member Party desires to make a public announcement (such as a press release) concerning the material terms of this Agreement, such Member Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Member Party for its prior review and approval (except as otherwise provided in this Section 12.5(b)), such approval not to be unreasonably withheld. A Member Party commenting on such a proposed announcement shall provide its comments, if any, as soon as reasonably practicable but in any event within three (3) Business Days after receiving the proposed announcement for review. Either Member Party shall have the right to make a press release announcing the receipt of Approvals, subject only to the review procedure set forth in the preceding sentence. Neither Member Party shall be required to seek the permission of the other Member Party to repeat any information as to the terms of this Agreement that have already been publicly disclosed by such Member Party in accordance with Section 12.2 or this Section 12.5. In the event of a legally required press release or other public announcement or disclosure, the Member Party in question shall provide the other Member Party with a copy of the proposed text with as much notice as practicable (which shall be no less than three (3) Business Days prior to the proposed disclosure), the other Member Party shall respond with its comments as promptly as practicable (but no less than one (1) Business Day prior to the proposed disclosure), and the Member Party in question shall take into due consideration any and all reasonable comments that such other Member Party may provide in a timely manner; provided , however , that if a Member Party determines that it must make a legally required disclosure under Regulation FD, then it shall have the right to make such disclosure at such time as is necessary to comply with Regulation FD and shall provide the other Member Party with as much notice and opportunity for review and comment as is practicable in the circumstances.

12.6 Notification . The Receiving Party shall notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential Information.

 

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12.7 Permitted Uses . Notwithstanding any provision of this Agreement to the contrary, regardless of which Member Party is the Disclosing Party, to the extent that any Confidential Information relates specifically to the Combination Product, including any such Confidential Information consisting of Combination Product Regulatory Documentation, each Member Party shall have the right to use such Confidential Information in connection with any Exploitation of the Combination Product to the extent permitted by the terms and conditions of this Agreement, including, without limitation (a) any use in accordance with the license grants made by the JV to the Member Parties in Section 6.2, or with the Rights of Reference granted by the JV to the Member Parties in Sections 6.4(b), 6.4(c) and 6.4(d), as the case may be, or (b) in connection with the preparation and/or submission to Regulatory Authorities as required in connection with any filing or application, or request for regulatory approval for the Combination Product anywhere in the world.

12.8 Remedies . Each Party agrees that the unauthorized use or disclosure of any material Confidential Information by the Receiving Party in violation of this Agreement may cause severe and irreparable damage to the Disclosing Party, for which money damages represent an insufficient remedy. In the event of any violation of this Section 12, notwithstanding anything in this Agreement to the contrary, the Disclosing Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, with respect to such violation as well as any other relief permitted by Applicable Law, and may obtain that relief without making a showing of insufficiency of money damages or irreparable harm. The Receiving Party agrees to waive any requirement that the Disclosing Party post bond as a condition for obtaining any such relief.

SECTION 13.

WARRANTIES; INDEMNITIES

13.1 Representations, Warranties and Covenants . Each Member Party hereby represents, warrants and covenants to the other Member Party as of the Effective Date (with respect to matters relating to the United States) and as of the Amended Effective Date (with respect to matters relating to Canada and corporate matters generally), as follows:

(a) Such Member Party as applicable (i) has the power and authority and the legal right to enter into this Agreement, the Operating Agreement and any Ancillary Agreements to which it is a party and to perform its obligations hereunder and thereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement, the Operating Agreement and any Ancillary Agreements to which it is a party. Each of this Agreement and the Operating Agreement has been (and in the case of any Ancillary Agreements to which such Member Party is a party, when executed and delivered, will have been) duly executed and delivered on behalf of such Member Party and constitutes (and in the case of any Ancillary Agreements to which such Member Party is a party, when duly executed and delivered, shall constitute) a legal, valid and binding obligation of such Member Party and is (and in the case of any Ancillary Agreements to which such Member Party is a party, when duly

 

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executed and delivered, shall be) enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.

(b) Such Member Party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such Member Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement such Party would violate, any of the intellectual property rights of any other Person (after giving effect to the license grants in this Agreement). On the Effective Date, such Member Party has delivered to the other Member Party a list setting forth, to the extent of such Member Party’s knowledge any and all (i) products liability litigation, (ii) intellectual property litigation that is reasonably likely to have a material adverse effect on such Member Party’s Single Agent Product(s) or Double Agent Product or the Combination Product, as applicable, or the rights or licenses granted by such Member Party to the other Member Party or the JV hereunder with respect to any such product, and (iii) litigation or investigation(s) initiated by, and warning letters received from, Regulatory Authorities, including Form 483 letters, in each case with respect to Manufacturing; and in each case ((i), (ii) and (iii)): (A) which relates to such Member Party’s Single Agent Product(s) or Double Agent Product, and (B) which litigation or investigation is currently pending or was pending, or which warning letter was received, at any time on or after [ * ]

(c) All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons required to be obtained by such Member Party in connection with the execution and delivery of this Agreement and the performance of its obligations under this Agreement have been obtained.

(d) With respect to such Member Party as applicable, the execution and delivery of this Agreement, the Operating Agreement and any Ancillary Agreements to which it is a party and the performance of such Member Party’s obligations hereunder and thereunder (i) do not conflict with or violate in any material way any requirement of Applicable Law, (ii) do not conflict with or violate any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Member Party, as applicable and (ii) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Member Party is bound.

13.2 Additional Representations, Warranties and Covenants of BMS . BMS represents, warrants and covenants to Gilead, as of the Effective Date (with respect to matters relating to the United States) and as of the Amended Effective Date (with respect to matters relating to Canada and corporate matters generally), that:

(a) Each of BMS Parent and BMS Sub (i) is a corporation or limited liability company, as the case may be, duly organized and in good standing under the laws of the State of Delaware, and (ii) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

 

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(b) Neither BMS nor any of its Affiliates has been debarred or is subject to debarment and neither BMS nor any of its Affiliates shall use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the U.S. Act, or who is the subject of a conviction described in such section. BMS agrees to inform Gilead in writing immediately if it or any Person who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the knowledge of BMS, is threatened, relating to the debarment or conviction of BMS or any Person performing services under this Agreement.

(c) BMS has the right to grant the license under the BMS Patents that is set forth in Section 6.1(b), and has not, prior to the Effective Date, made a grant to any Third Party of any right or license in respect of the BMS Patents that would conflict with any grant of rights or licenses to Gilead or the JV hereunder. The BMS Patents are not subject to any encumbrance or lien by any Third Party (except for any such encumbrances or liens as would not, in the aggregate, have a material adverse effect on the license rights granted to the JV and Gilead under this Agreement). Prior to the Effective Date, BMS has delivered to Gilead a copy (with financial terms redacted) of any license or similar grant of rights between BMS, on the one hand, and a Third Party, on the other hand, (i) pursuant to which BMS obtained from such Third Party a license or other rights with respect to any of the BMS Patents, or (ii) pursuant to which BMS grants to any such Third Party a license or other rights with respect to any of the BMS Patents for Exploitation in the Territory. BMS covenants and agrees that, except for agreements referred to in the preceding sentence (including extensions, amendments and renewals thereof), it shall not, from and after the Effective Date and throughout the term of this Agreement, grant to any Third Party any right or license in respect of the BMS Patents that would conflict with any grant to Gilead or the JV hereunder.

(d) There are no judgments or settlements against or amounts with respect thereto owed by BMS relating to the BMS Patents. To the knowledge of BMS, it has not received written notice of any Proceeding in which it is alleged that (i) the BMS Patents are invalid or unenforceable or (ii) the Exploitation of EFV, whether alone or in combination with either or both of TDF and FTC, infringes any Third Party Patent.

(e) To the knowledge of BMS, the information contained in BMS’ Single Agent Product label and in the NDA and NDS for BMS’ Single Agent Product represents, in all material respects, a complete and accurate reflection of the safety and efficacy profile of BMS’ Single Agent Product as of the Effective Date. BMS shall use commercially reasonable efforts to maintain its Single Agent Product label and the BMS Regulatory Documentation through updates as needed to ensure that such information continues to represent a complete and accurate reflection in all material respects of the safety and efficacy profile of its Single Agent Product. It is understood and agreed that BMS makes the representation and covenant to Gilead set forth in this Section 13.2(e) solely for purposes of the Member Parties’ collaboration pursuant to this Agreement, and for no other purpose.

 

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(f) Quantities of EFV provided by BMS pursuant to Section 4.1 will (i) be Manufactured using reasonable care; (ii) conform to the applicable EFV Bulk Specifications (as defined in the BMS Supply Agreement) and with the applicable certificate of analysis at the time of delivery; (iii) be conveyed by BMS with good title and free from any lawful security interest, lien or encumbrance; and BMS (or any Affiliates or Third Party suppliers as applicable) will have obtained all approvals required by all applicable Regulatory Authorities to Manufacture EFV for use in Sustiva.

13.3 Additional Representations, Warranties and Covenants of Gilead . Gilead represents, warrants and covenants to BMS, as of the Effective Date (with respect to matters relating to the United States) and as of the Amended Effective Date (with respect to matters relating to Canada and corporate matters generally), that:

(a) Each of Gilead Parent and Gilead Sub is a corporation or limited liability company, as the case may be, duly organized, validly existing and in good standing under the laws of the State of Delaware, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by this Agreement.

(b) Neither Gilead nor any of its Affiliates has been debarred or is subject to debarment and neither Gilead nor any of its Affiliates shall use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section. Gilead agrees to inform BMS in writing immediately if it or any Person who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the knowledge of Gilead, is threatened, relating to the debarment or conviction of Gilead or any Person performing services under this Agreement.

(c) Gilead has the right to grant the license under the Gilead Patents that is set forth in Section 6.1(a), and has not, prior to the Effective Date, made a grant to any Third Party of any right or license in respect of the Gilead Patents that would conflict with any grant of rights or licenses to BMS or the JV hereunder. The Gilead Patents are not subject to any encumbrance or lien by any Third Party (except for any such encumbrances or liens as would not, in the aggregate, have a material adverse effect on the license rights granted to the JV and BMS under this Agreement). Prior to the Effective Date, Gilead has delivered to BMS a copy (with financial terms redacted) of any license or similar grant of rights between Gilead, on the one hand, and a Third Party, on the other hand, (i) pursuant to which Gilead obtained from such Third Party a license or other rights with respect to any of the Gilead Patents, or (ii) pursuant to which Gilead grants to any such Third Party a license or other rights with respect to any of the Gilead Patents for Exploitation in the Territory. Gilead covenants and agrees that, except for agreements referred to in the preceding sentence (including extensions, amendments and renewals thereof), it shall not, from and after the Effective Date and throughout the term of this Agreement, grant to any Third Party any right or license in respect of the Gilead Patents that would conflict with any grant to Gilead or the JV hereunder.

 

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(d) There are no judgments or settlements against or amounts with respect thereto owed by Gilead relating to the Gilead Patents. To the knowledge of Gilead, it has not received written notice of any Proceeding in which it is alleged that (i) the Gilead Patents are invalid or unenforceable or (ii) the Exploitation of either TDF or FTC, whether alone or together and whether or not in combination with EFV, infringes any Third Party Patent.

(e) To the knowledge of Gilead, the information contained in the labels of Gilead’s Single Agent Products and Double Agent Product and in the NDAs and NDSs for Gilead’s Single Agent Products and Double Agent Product represents, in all material respects, a complete and accurate reflection of the safety and efficacy profile of Gilead’s Single Agent Products and Double Agent Product as of the Effective Date. Gilead shall use commercially reasonable efforts to maintain its Single and Double Agent Product labels and the Gilead Regulatory Documentation through updates as needed to ensure that such information continues to represent a complete and accurate reflection in all material respects of the safety and efficacy profile of its Single and Double Agent Products. It is understood and agreed that Gilead makes the representation and covenant to BMS set forth in this Section 13.3(e) solely for purposes of the Member Parties’ collaboration pursuant to this Agreement, and for no other purpose.

(f) Quantities of FTC and TDF provided by Gilead pursuant to Section 4.1 will (i) be Manufactured using reasonable care; (ii) conform to the applicable Product Specifications (as defined in the Gilead Supply Agreement) and with the applicable certificate of analysis at the time of delivery; (iii) be conveyed by Gilead with good title and free from any lawful security interest, lien or encumbrance; and Gilead (or any Affiliates or Third Party suppliers as applicable) will have obtained all approvals required by all applicable Regulatory Authorities to Manufacture FTC and TDF for use in Viread, Emtriva and Truvada as applicable.

13.4 Disclaimer . EXCEPT AS SET FORTH IN SECTIONS 13.1, 13.2 AND 13.3, EACH PARTY HEREBY DISCLAIMS ANY AND ALL WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WITH RESPECT TO THE SINGLE AGENT PRODUCTS, THE DOUBLE AGENT PRODUCT, THE COMBINATION PRODUCT OR ANY ACTIVE PHARMACEUTICAL INGREDIENTS FOR THE COMBINATION PRODUCT SUPPLIED UNDER THIS AGREEMENT, OR ANY TECHNOLOGY LICENSED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. FOR THE AVOIDANCE OF DOUBT, NOTHING CONTAINED IN THIS SECTION 13.4 SHALL OPERATE TO LIMIT OR INVALIDATE ANY WARRANTY CONTAINED IN ANY ANCILLARY AGREEMENT.

13.5 Indemnification by the JV . The JV shall indemnify each of the Member Parties and their Affiliates and their respective officers, directors and employees from and against (a) (i) all Proceedings in which such Member Party (or its Affiliate) is involved or threatened to be involved and which arises out of the Exploitation of the Combination Product or either Member Party’s (or its Affiliate’s) performance of its obligations under and in compliance

 

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with this Agreement, the Operating Agreement, the SDEA or the MTTA and (ii) all Losses incurred by the indemnitee resulting from such Proceedings, and (b) without limitation of the foregoing clause (a), (i) all Proceedings in which such Member Party (or its Affiliate) is involved or threatened to be involved and which arises out of (A) the content of any Approved Marketing Materials, to the extent that such Approved Marketing Materials are used by both Member Parties, (B) the performance of such Member Party’s duties under Section 3.3 (with respect to formulation and Manufacturing process development related activities), 5.2, 5.3, 5.4, 7.1 or 8.1 of this Agreement, (C) the performance by the Tax Matters Member of its duties under the Operating Agreement, or (D) the JV’s use of the Combination Product Trademarks, the Gilead Licensed Trademarks, and/or the BMS Licensed Trademarks, and (ii) all Losses incurred by the indemnitee resulting from such Proceedings, except in each case ((a) and (b)) to the extent that such Proceedings arise out of or such Losses were caused by the indemnitee Member Party’s (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA, and except in each case ((a) and (b)) to the extent that the other Member Party has an obligation of indemnity for such Losses and Proceedings pursuant to Section 13.6, 13.7 or Section 11.4, as the case may be. The indemnification provided in this Section 13.5 shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any applicable, statutes, agreement, vote of the JEC or otherwise. Except as otherwise expressly provided in this Agreement, including without limitation this Section 13.5 or Section 13.6 or 13.7, all Losses incurred by the JV shall be borne by the Member Parties in accordance with the terms of the Operating Agreement.

13.6 Indemnification by the Member Parties in General . Each Member Party (the “Indemnifying Member Party”) shall indemnify the JV and the other Member Party and its Affiliates and their respective officers, directors and employees from and against (a) all Proceedings in which the JV or such other Member Party (or its Affiliate) is involved or threatened to be involved and which arises out of (i) the Indemnifying Member Party’s (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA, or (ii) the content of any Approved Marketing Materials used by the Indemnifying Member Party in accordance with Section 5.7, following its receipt of notification from the other Member Party in accordance with Section 5.7 that the other Member Party has elected not to use such Approved Marketing Materials in the Promotion of the Combination Product in the Territory (and provided that the other Member Party does not use such Approved Marketing Materials in the Promotion of the Combination Product in the Territory), and (b) all Losses incurred by the indemnitee resulting from such Proceedings, except to the extent that such Proceedings arise out of or such Losses were caused by the other Member Party’s (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA, and except to the extent a Member Party or the JV has an obligation of

 

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indemnity for Losses and Proceedings pursuant to Section 13.7 or Section 11.4 or Section 13.5, as the case may be. The indemnification provided in this Section 13.6 shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any applicable statutes, agreement, vote of the JEC or otherwise.

13.7 Indemnification for Certain Product Liability Related Matters .

(a) Gilead shall indemnify the JV and each BMS Indemnified Party from and against (i) all Proceedings in which the JV or such BMS Indemnified Party is involved or threatened to be involved and which arise from personal injury or death caused by the Combination Product due to design defects, manufacturing defects or the inherent characteristics thereof, where the [ * ] that such defect(s) or characteristics are the direct result of the incorporation in the Combination Product of TDF, FTC or both TDF and FTC, in each case without reference to the incorporation in the Combination Product of EFV (other than any Selected Product Liability Claims), irrespective of whether such defect(s) or characteristics (or any associated defects or characteristics of TDF and/or FTC) are [ * ] and (ii) all Losses incurred by the JV or such BMS Indemnified Party, as the case may be, resulting from such Proceedings, except to the extent that such Proceedings arise out of or such Losses were caused by BMS’ (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA.

(b) BMS shall indemnify the JV and each Gilead Indemnified Party from and against (i) all Proceedings in which the JV or such Gilead Indemnified Party is involved or threatened to be involved and which arise from personal injury or death caused by the Combination Product due to design defects, manufacturing defects or the inherent characteristics thereof, where the [ * ] that such defect(s) or characteristics are the direct result of the incorporation in the Combination Product of EFV, in each case without reference to the incorporation in the Combination Product of either or both of TDF and FTC (other than any Selected Product Liability Claims), irrespective of whether such defect(s) or characteristics (or any associated defects or characteristics of EFV) are [ * ] and (ii) all Losses incurred by the JV or such Gilead Indemnified Party, as the case may be, resulting from such Proceedings, except to the extent that such Proceedings arise out of or such Losses were caused by Gilead’s (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA.

(c) The JV shall indemnify each of the Gilead Indemnified Parties and BMS Indemnified Parties from and against (i) all Proceedings in which any such Gilead Indemnified Party or BMS Indemnified Party, as the case may be, is involved or threatened to be involved and which arise from personal injury or death caused by the Combination Product due to design defects, manufacturing defects or the inherent characteristics thereof, (A) where the [ * ] that such defect(s) or characteristics are the direct result of both (1) EFV and (2) either or both of TDF and/or FTC being incorporated into the Combination Product, (B) where it ultimately

 

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cannot be or is not determined whether such defect(s) or characteristics are the direct result of EFV, on the one hand, and either or both of TDF and FTC, on the other hand, being incorporated into the Combination Product, or (C) where such defect(s) or characteristics are the direct result of an aspect of the Combination Product other than any of its active ingredients (each such claim ((A), (B) or (C)) a “Selected Product Liability Claim”); and (ii) all Losses incurred by the Gilead Indemnified Party or BMS Indemnified Party, as the case may be, resulting from such Proceedings; in each case except to the extent that such Proceedings arise out of or such Losses were caused by a Member Party’s (or its Affiliate’s or subcontractor’s) gross negligence, willful misconduct, failure to comply with or perform one or more of its covenants in this Agreement, the Operating Agreement, the SDEA or the MTTA, or breach or inaccuracy of one or more of its representations and warranties in this Agreement, the Operating Agreement or (if applicable) the SDEA, and except to the extent a Member Party has an obligation of indemnity for such Losses and Proceedings pursuant to Section 11.4.

(d) For purposes of Sections 13.7(b) and 13.7(c) only, [ * ] shall be deemed to be an Affiliate of Gilead; provided, however, that BMS shall have no greater scope of liability to [ * ] pursuant to this Section 13.7(d) than the lesser of (i) the scope of liability of BMS to Gilead pursuant to Section 13.7(b) and (ii) the scope of liability of Gilead to [ * ] pursuant to [ * ] of [ * ] as of the Effective Date.

13.8 Indemnification Procedure .

(a) Each Indemnified Party agrees to give the Indemnifying Party prompt written notice of any Losses or the discovery of a fact (including any Proceeding) upon which such Indemnified Party intends to base a request for indemnification under Section 11.4, 13.5, 13.6 or 13.7, as the case may be (it being understood and agreed, however, that the failure to give notice as provided in this Section 13.8(a) shall not relieve the Indemnifying Party of any such indemnification obligations except and only to the extent that the Indemnifying Party is actually materially prejudiced as a result of such failure to give notice).

(b) Each Party shall furnish promptly to the other Parties, copies of all papers and official documents received in respect of any Proceedings. The Indemnified Party shall reasonably cooperate as requested by and at the expense of the Indemnifying Party in the defense of any Proceedings.

(c) With respect to any Losses relating solely to the payment of money damages and which shall not result in the Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affecting the Indemnified Party in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party under this Agreement, the Indemnifying Party shall have the sole right to defend, settle or otherwise dispose of such Proceeding, on such terms as the Indemnifying Party shall deem appropriate.

(d) With respect to all Losses other than those addressed in Section 13.8(c), and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party under this Agreement, the Indemnifying Party

 

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shall have the sole right to control the defense of the relevant Proceeding, provided that the Indemnifying Party shall obtain the written consent of the Indemnified Party, which shall not be unreasonably withheld, prior to ceasing to defend, settling or otherwise disposing of any Proceeding if as a result thereof (i) the Indemnified Party would become responsible for the payment of any money damages or other costs (with respect to which the Indemnifying Party has contested or challenged or may contest or challenge its obligation to indemnify), (ii) the Indemnified Party would become subject to injunctive or other equitable relief or any remedy other than the payment of money by the Indemnifying Party or (iii) the Indemnified Party would otherwise be adversely affected.

(e) Furthermore, with respect to each of Section 13.8(c) and 13.8(d), the Indemnifying Party shall be entitled to control the proceeding only if it so notifies the Indemnified Party within thirty (30) days after delivery of the notice by the Indemnified Party under Section 13.8(a).

(f) The Indemnifying Party shall not be liable for any Losses resulting from any settlement or other disposition of a Proceeding by the Indemnified Party which is reached without the written consent of the Indemnifying Party.

(g) The allocation among the Member Parties and the JV of any liability for a Loss or Proceeding, if not otherwise determined in a court of law, shall be considered by the JEC and, if the JEC does not reach agreement on such allocation, by unanimous Member Vote or unanimous written consent of its members, either Member Party shall have the right to refer the dispute to arbitration pursuant to Section 15.6. The dispute resolution procedures in Section 2.8 shall not apply to any disputes arising under this Section 13.8(g).

(h) The out-of-pocket expenses reasonably incurred by any Indemnified Party in connection with any Proceeding shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

13.9 Limitation on Damages . Except for breaches of Section 12, the Parties shall not be liable to each other for special, indirect, incidental or consequential damages (including, without limitation, for lost profits), whether in contract, warranty, negligence, tort, strict liability or otherwise, arising out of any breach or failure to perform any provision(s) of this Agreement; provided , however , that the Parties shall be liable to each other for [ * ] and provided , further , that the Parties shall be liable to each other for [ * ] provided that such breaches are intentional or arise out of acts or omissions constituting gross negligence. Nothing in this Section 13.9 is intended to or shall operate to limit a Party’s obligations of indemnity with respect to losses awarded to third parties in a proceeding under Sections 11.4, 13.5, 13.6 and 13.7.

13.10 Ancillary Agreements . Any reference in this Agreement to an Ancillary Agreement (other than the SDEA) or any obligation under any such Ancillary Agreement, shall

 

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not be construed to include within the scope of the indemnification obligations of the Parties under this Agreement any liability arising out of any such Ancillary Agreement or any obligation under any such Ancillary Agreement.

13.11 Employees . The Parties agree that, as among the Parties, all actions taken or omitted to be taken by any employee of a Member Party (or any of its Affiliates) in his or her capacity as a member of the JEC, any Operating Committee or the US Pricing Committee, and all other actions taken or omitted to be taken by any employee of a Member Party (or any of its Affiliates) with respect to the Project Activities, shall be attributed only to such Member Party. Accordingly, any claims by the other Member Party or the JV arising out of such actions or inactions shall be asserted directly against the Member Party who is (or whose Affiliate is) such individual’s employer, and such other Member Party, or the JV, as the case may be, hereby waives any such claims against such individual.

SECTION 14.

TERM AND TERMINATION

14.1 Term . The term of this Agreement shall commence as of the Effective Date and shall continue until terminated by mutual agreement of the Parties or otherwise in accordance with this Section 14.

14.2 Certain Litigation . This Agreement shall terminate upon notice given by either Member Party to the other Member Party in the event that any U.S. governmental authority seeks or obtains a temporary restraining order or preliminary injunction to enjoin the transactions contemplated by this Agreement or institutes litigation seeking other relief in respect of such transactions under any Applicable Law in the United States.

14.3 Termination with respect to Canada .

(a) Either Member Party may terminate this Agreement, solely as to Canada, by notice to the other Member Party if either (i) no NDS for the Combination Product in the Field is filed by [ * ] or (ii) no NDS for the Combination Product in the Field is approved by [ * ]

(b) This Agreement shall terminate with respect to Canada upon notice given by either Member Party to the other Member Party in the event that any [ * ] under any Applicable Law in Canada.

14.4 Material Default .

(a) If a Member Party (the “Breaching Member Party”) fails to comply with or perform, in any material respect, any of its material obligations contained in this Agreement or the Operating Agreement, or any act or omission by such Member Party causes a failure by the JV to comply with or perform, in any material respect, any of its material obligations contained in this Agreement or the Operating Agreement (any such default, a

 

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“Material Default”), then the other Member Party (the “Non-Breaching Member Party”) shall have the right to give to the Breaching Member Party notice specifying the nature of the Material Default. The Breaching Member Party shall have a period of sixty (60) days after receipt of such notice to fully cure the Material Default in a manner reasonably acceptable to the Non-Breaching Member Party, and, if it does not do so within such period, the Member Parties shall discuss in good faith appropriate adjustments to or cancellation of the Member Parties’ respective obligations under this Agreement to permit the continuation of this Agreement and the JV on a mutually agreeable basis. For the avoidance of doubt, the Non-Breaching Member Party may, in its sole discretion, deliver a notice of Material Default to the Breaching Member Party prior to completion of the dispute resolution procedures set forth in Section 2.9, in which case the sixty (60) day cure period referred to in the preceding sentence shall begin to run upon receipt of such notice and shall run concurrently with such procedures.

(b) If the Breaching Member Party does not cure a Material Default pursuant to Section 14.4(a) and the Member Parties’ discussions pursuant to the last sentence of Section 14.4(a) do not lead to a mutually agreeable restructuring of this Agreement, then if the Non-Breaching Member Party and the Breaching Member Party mutually agree that it is both desirable and practicable to withdraw the Combination Product from the market in the Territory, the Non-Breaching Member Party shall have the right to terminate this Agreement as a whole upon notice to the Breaching Member Party given within thirty (30) days of the cessation of the Member Parties’ discussions pursuant to the last sentence of Section 14.4(a). Any such termination shall be effective upon such withdrawal, and the Member Parties shall cooperate with each other and cause the JV to effect such withdrawal as promptly as practicable under Applicable Law.

(c) Whether or not there is a termination of this Agreement pursuant to Section 14.4(b), the Non-Breaching Member Party shall have the right to seek damages on account of the Material Default in an arbitration pursuant to Section 15.6. The express remedies of the Non-Breaching Member Party pursuant to this Section 14.4 shall be in addition to any other remedies in favor of the Non-Breaching Member Party (or, if applicable, the JV) provided for in this Agreement or the Operating Agreement, as applicable, or under the BMS Guarantee Agreement or Gilead Guarantee Agreement, as applicable.

(d) The Parties acknowledge that each Member Party has entered into this Agreement and the Operating Agreement in reliance on the other Member Party’s continued compliance with, and performance of, its obligations under this Agreement and the Operating Agreement. Accordingly, each Member Party agrees that any Material Default may cause severe and irreparable damage to the Non-Breaching Member Party or the JV as applicable, for which money damages would represent an insufficient remedy. In the event of any such Material Default, notwithstanding anything in this Agreement to the contrary, the Non-Breaching Member Party shall be authorized and entitled to seek from any arbitrator under Section 15.6 the remedy of specific performance with respect to any such Material Default, as well as any other relief permitted by Applicable Law and may obtain that relief without making a showing of the insufficiency of money damages. The Breaching Member Party agrees to waive any requirement that the Non-Breaching Member Party post bond as a condition for obtaining any such relief.

 

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14.5 Termination Upon Generic Launch [ * ] Either Member Party (the “Continuing Member Party”) may terminate this Agreement [ * ] by notice to the other Member Party (the “Terminated Member Party”) in the event that there is the Launch in the [ * ] of at least one (1) Generic Version of all of the Single Agent Products (or the Double Agent Product) of the Terminated Member Party (a “Generic Version Launch”) and the Continuing Member Party delivers notice of termination within thirty (30) days after the Generic Version Launch. Such termination shall be effective on the last day of the Calendar Quarter in which such notice is given. For the avoidance of doubt, [ * ]

14.6 Consequences of Termination .

(a) Termination Pursuant to Sections 14.2 or 14.4(b) . If a Member Party terminates this Agreement pursuant to Section 14.2 or 14.4(b), (i) the license and sublicense grants and Rights of Reference in Section 6 from the Member Parties to the JV shall terminate, (ii) the Rights of Reference and license grants in Section 6.3(a)(1) and 6.3(b)(1) shall survive solely to the extent necessary in order for the licensee Member Party to support the labeling of its Single Agent Product(s) and/or Double Agent Product, as applicable, as approved as of the effective date of such termination, (iii) the license grants in Section 6.3(a)(2) and 6.3(b)(2) shall survive, (iv) the license grants and Rights of Reference in Section 6 from the JV to the Member Parties shall survive until the first date on which the JV has been dissolved and any and all intangible Property (as defined in the Operating Agreement) has been distributed in kind to the Member Parties pursuant to Section 10.2(c) of the Operating Agreement, (v) unless Gilead is the Breaching Member Party, the licenses and other rights granted to Gilead in Sections 6.2(d) and 6.4(d) with respect to the Combination Product outside the United States, Canada and Europe shall survive (in which event such licenses and other rights shall be deemed to be granted by BMS directly to Gilead), (vi) the JV shall be dissolved in accordance with the Operating Agreement and, in connection with such dissolution, each Combination Product Trademark shall be sold to a Member in a bidding process, (vii) the Operating Agreement and the Ancillary Agreements shall terminate (except as expressly provided in any such agreement) and (viii) each Member Party shall promptly (and in any event within thirty (30) days thereafter) make arrangements for the return or disposal, at the other Member Party’s option, of any Confidential Information, in tangible or intangible form (except for (x) one (1) copy which may be retained solely for archival purposes and (y) Confidential Information relating to any surviving licenses and other rights described above).

(b) Termination Pursuant to Section 14.5 . Upon termination of this Agreement pursuant to Section 14.5, the JV shall not be dissolved and the following terms and conditions shall apply:

(A) The license grants and Rights of Reference in Section 6 from the Terminated Member Party to the JV shall survive (except for the trademark license grants in Section 6.6, which shall survive only to the extent necessary to enable the Continuing Member Party to identify the Terminated Member Party on the label of the Combination Product and/or in the Combination Product Regulatory Documentation, as required by Applicable Law); (B) if Gilead is the Terminated Member Party, the license grant in Section 6.7 from the JV to Gilead shall terminate; (C) the license and sublicense grants in Section 6.2 from the JV to the Terminated Member Party

 

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shall terminate (other than Section 6.2(a)(3) or 6.2(b)(3), as applicable), and 6.2(c) and, if Gilead is the Terminated Member Party, other than the sublicense grant in Section 6.2(d) which shall be addressed as set forth in clause (F) below); (D) the license grants and Rights of Reference from a Member Party to the other Member Party in Section 6.3 shall survive; (E) the Rights of Reference from the JV to the Terminated Member Party in Section 6.4(b) or 6.4(c) shall survive; and (F) if Gilead is the Terminated Member Party, the sublicenses and Rights of Reference granted to Gilead in Sections 6.2(d) and 6.4(d) with respect to the Combination Product outside the United States, Canada and Europe shall survive.

The Continuing Member Party shall pay or cause the JV to pay to the Terminated Party, in the manner set forth in Sections 7.3(b) and (d) and subject mutatis mutandis to Section 7.4, with respect to the period from the effective date of such termination through the [ * ] thereof, an amount determined pursuant to the following formula (with Net Sales and Net Selling Prices in each case being determined solely for the United States and the applicable yearly period):

Net Sales of the Combination Product in the United States * ([ * ] – [ * ]]/[ * ]), multiplied by the following percentages for the following twelve (12)-month periods commencing with the effective date of termination:

[ * ]

[ * ]

[ * ]

The JV or other paying Member Party shall pay any amounts owed to a Member Party pursuant to this Section 14.6(b)(ii) within sixty (60) days of the end of the Calendar Quarter in which the relevant Net Sales were invoiced. Each such payment shall be accompanied by a written report, providing a detailed breakdown of the calculation of amounts paid for the relevant period.

The Terminated Member Party, at its own election (of which it shall promptly notify the Continuing Member Party in writing), shall (pursuant to a license and/or supply agreement containing the following terms and any other terms upon which the Member Parties mutually agree) either (A) enable the Continuing Member Party to Manufacture quantities of EFV or TDF and FTC, as the case may be, in bulk active pharmaceutical ingredient form for use in the Manufacture of the Combination Product for use in the Territory, in which event the Terminated Member Party shall (1) automatically be deemed to grant a royalty-free, non-exclusive license to the Continuing Member Party (or its Third Party designee, which shall be reasonably acceptable to the Terminated Member Party) under the Terminated Member Party’s Patents covering such Manufacture and Information and Inventions used in such Manufacture by or on behalf of the Terminated Member Party, to Manufacture such ingredient(s) for the sole purpose of using such ingredient(s) in the Manufacture of the Combination Product for the Territory, and (2) provide reasonable technical assistance to such Continuing Member Party or Third Party designee (which choice of recipient shall be subject to the prior approval of the Terminated Member Party, such approval not to be unreasonably withheld or delayed), at the Continuing Member Party’s expense on the Terminated Member Party’s then-current standard terms and conditions; or (B) continue

 

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to supply to the JV (or its designee) on a non-exclusive basis such quantities of EFV or TDF and FTC, as the case may be, in bulk active pharmaceutical ingredient form, as such Continuing Member Party may request for Manufacture of the Combination Product for the Territory, at a transfer price of such supply equal to [ * ] of the Cost of Goods. Notwithstanding the foregoing, thereafter, the Terminated Member Party may elect pursuant to clause (B) above to continue to supply the applicable bulk active pharmaceutical ingredient, or determine to cease to Manufacture such ingredient(s) or that it otherwise desires to terminate the aforementioned supply arrangement with the Continuing Member Party, at a time when the Continuing Member Party is still Manufacturing or having Manufactured the Combination Product. In the event that the Terminated Member Party elects to cease the Manufacture of such ingredient(s) or otherwise desires to terminate such supply arrangement, the Terminated Member Party shall (x) give the Continuing Member Party at least [ * ] written notice prior to ceasing such Manufacture or otherwise terminating such agreement, (y) grant to the Continuing Member Party the license described in clause (A)(1) above, and (z) provide to the Continuing Member Party the technical assistance described in clause (A)(2) above. In the event that the Terminated Member Party and the JV or the Continuing Member Party enter into a supply arrangement for bulk active pharmaceutical ingredient(s) pursuant to the first sentence of this Section 14.6(b)(iii), and thereafter the JV or such Continuing Member Party, as the case may be, desires to terminate such supply arrangement (without receiving from the Terminated Member Party the license described in clause (A)(1) above or the technical assistance described in clause (A)(2) above), the JV or such Continuing Member Party, as the case may be, shall provide [ * ] written notice thereof to the Terminated Member Party. The JV and the Continuing Member Party shall be responsible for all Third Party royalties payable by the Terminated Member Party in respect of any supply provided by the Terminated Member Party pursuant to this Section 14.6(b)(iii).

Upon the termination of this Agreement, the name of the JV shall be changed to remove the name of the Terminated Member Party, and the Continuing Member Party shall not, and shall cause the JV not to, include the Trademark or name of the Terminated Member Party on the labeling, packaging and advertising materials of the Combination Product, or otherwise in connection with the JV’s business with respect to the Combination Product in the Territory.

The Terminated Member Party shall promptly (and in any event within thirty (30) days thereafter) make arrangements for the return or disposal, at the Continuing Member Party’s option, of any Confidential Information, in tangible or intangible form (except for (x) one (1) copy which may be retained solely for archival purposes and (y) Confidential Information relating to any surviving licenses and other rights pursuant to Section 14.6(b)(i)).

Except as otherwise expressly provided in the Operating Agreement and/or any Ancillary Agreement, the Operating Agreement and the Ancillary Agreements shall terminate with respect to the Territory.

The JV shall immediately discontinue use of the Terminated Member Party’s Trademarks, and the license granted by the Terminated Member Party to the JV to use the Terminated Member Party’s Trademarks shall immediately revert to the Terminated Member Party, in each case with respect to the Territory.

For the avoidance of doubt, the pricing and other provisions contained in Section 5.3, the [ * ] and the [ * ] shall terminate.

(c) Termination of Canada Pursuant to Sections 14.3 . If a Member Party terminates this Agreement pursuant to Section 14.3 with respect to Canada, as of the

 

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effective date of such termination (i) the Territory shall exclude Canada, (ii) the obligations of the Parties with respect to the development and commercialization of the Combination Product in Canada, including without limitation obtaining and maintaining any Approvals for the Combination Product in Canada, shall cease, including without limitation any obligations under the Canadian Commercialization Plan or any Development Activities with respect to Canada as set forth in the Development Plan with respect to Canada attached hereto as Annex V, (iii) the JCOC shall cease to operate, and (iv) each Member Party shall promptly (and in any event within [ * ] thereafter) make arrangements for the return or disposal, at the other Member Party’s option, of any Confidential Information relating solely to Canada, in tangible or intangible form (except for (A) one (1) copy which may be retained solely for archival purposes and (B) Confidential Information relating to the licenses and other rights granted in Section 6). Such termination shall not effect any other provisions of this Agreement, which shall remain in effect.

14.7 Rights in Bankruptcy . All rights and licenses granted under or pursuant to this Agreement by the JV, BMS or Gilead are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The Parties agree that the JV, BMS and Gilead, as licensees of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against the JV or either Member Party under the United States Bankruptcy Code, the non-subject Parties shall be entitled to a complete duplicate of (or complete access to, as the non-subject Party deems appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in their possession, shall be promptly delivered to them (a) upon any such commencement of a bankruptcy proceeding upon a non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by a non-subject Party. The provisions of this Section 14.7 are without prejudice to any rights the non-subject Parties may have arising under the U.S. Bankruptcy Code or other Applicable Law.

14.8 Accrued Rights; Surviving Obligations .

(a) Termination or expiration of this Agreement in its entirety or with respect to either country in the Territory shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.

(b) Without limiting anything contained in this Section 14, Sections 1, 3.6, 3.11 (which provision shall be implemented by the Member Parties), 5.10, 6 (as modified by 14.6 or 14.7), 7 (for payments pursuant to Section 14.6(b)(ii)), 8, 9, 11.1, 11.2, 11.3, 11.4, 12, 13.2(e) (as to the second sentence thereof) 13.3(e), (as to the second sentence thereof), 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 13.10, 13.11, 14.4(d) (as it applies to other surviving provisions), 14.6, 14.7 (for surviving rights and licenses), 14.8 and 15 shall survive the termination or expiration of this Agreement in its entirety for any reason.

 

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SECTION 15.

GENERAL PROVISIONS

15.1 Force Majeure . No Party shall be held liable or responsible to the other Parties or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, except for the payment of any amounts under this Agreement, when such failure or delay is caused by or results from causes beyond the reasonable control of the non-performing Party, including, without limitation, fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotion, acts of God or acts, omissions or delays in acting by any governmental authority. The non-performing Party shall notify the other Parties of such force majeure within five (5) days after such occurrence by giving written notice to the other Parties stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use, throughout the period of suspension of performance, commercially reasonable efforts to remedy its inability to perform; provided , however , that in the event the suspension of performance continues for ninety (90) days after the date such force majeure commences, the Parties shall meet to discuss in good faith how to proceed in order to accomplish the Collaboration Principles. For purposes of this Agreement a force majeure shall not include a failure to commit sufficient resources, financial or otherwise, to the Project Activities or general market or economic conditions.

15.2 Notice . All notices, requests, reports, statements and other communications to any Party (other than as specified in Section 2.7(c)) shall be in writing, shall refer specifically to this Agreement and shall be delivered personally, sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, to the following respective addresses (or to such other address as may be specified by notice from time to time by the relevant Party):

if to Gilead, to:

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Attn: EVP and CFO

with copies to:

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Attn: VP and General Counsel

and:

 

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Covington & Burling

One Front Street

San Francisco, CA 94111

Attn: James C. Snipes, Esq.

if to BMS, to:

Bristol-Myers Squibb Worldwide Medicines Group

Route 206 and Province Line Road

Princeton, NJ 08540

Attn: Vice President and Senior Counsel, Corporate and Business Development

with a copy to:

Hughes Hubbard & Reed LLP

One Battery Park Plaza

New York, NY 10004

Attn: Ellen S. Friedenberg, Esq.

Any such communication shall be deemed to have been given (i) when delivered, if personally delivered during the recipient’s normal business hours, (ii) on the Business Day after dispatch, if sent by nationally-recognized overnight courier and proof of delivery is obtained, and (iii) on the third (3rd) Business Day following the date of mailing, if sent by mail. It is understood and agreed that this Section 15.2 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement. Whenever this Agreement requires or permits the giving of notice by a Member Party, such notice may be given by BMS Parent on behalf of itself and BMS Sub, and by Gilead Parent on behalf of itself and Gilead Sub.

15.3 Further Assurances . Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further ministerial, administrative or similar acts and things, including, without limitation, the filing of such assignments, agreements, documents and instruments, as may be necessary or as another Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

15.4 Successors and Assigns .

(a) The terms and provisions hereof shall inure to the benefit of, and be binding upon, the Parties and their respective successors and permitted assigns. Except as expressly permitted pursuant to Sections 3.5, 4.1, 4.2 and 5.5, no Member Party may, without the prior written consent of the other Member Party, assign or otherwise transfer any of its rights and interests or subcontract or otherwise delegate any of its obligations under this Agreement; provided , however , that (i) either Member Party, without such consent, may assign its rights and

 

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delegate its duties under this Agreement to an Affiliate which is a directly or indirectly wholly-owned subsidiary of Gilead Parent or BMS Parent, as the case may be; provided , however , that the assigning Member Party shall remain primarily (and not secondarily or derivatively) liable for the full and timely performance by such Affiliate of all its obligations under this Agreement; and provided , further , that, except as set forth in clause (ii) below, such assignment or delegation shall terminate automatically at such time, if any, as such Affiliate ceases to be wholly-owned, directly or indirectly, by Gilead Parent or BMS Parent, as the case may be, and (ii) either Member Party, without such consent, may assign its rights and delegate its duties under this Agreement, whether by contract or operation of law, to a Third Party Acquirer in the event of a Change of Control of such Member Party. Any permitted successor or assignee of rights and/or obligations hereunder (a “Permitted Assignee”) shall, in a writing delivered to the other Parties at the time of such assignment, expressly assume performance of such rights and/or obligations. The JV may not assign this Agreement without the prior written consent of the Member Parties. Any purported assignment, transfer, subcontract or delegation by either Member Party or the JV in violation of the terms of this Section 15.4 shall be null and void and of no legal effect.

(b) In the event of any Change of Control of a Member Party (the “Transferring Member Party”), the Transferring Member Party shall give the other Member Party written notice thereof within ten (10) days, identifying such Third Party Acquirer. If at the time of such Change of Control such Third Party Acquirer is marketing in the Territory a Competing Product that was commercially available as of the Effective Date, then upon written notice from the other Member Party at its election to the Transferring Member Party within thirty (30) days of such other Member Party’s receiving written notice of such Change of Control, such Third Party Acquirer shall have [ * ] If such Third Party Acquirer fails to [ * ] (i) the performance obligations (other than payment obligations) of the Member Parties under this Agreement shall terminate, except to the extent of those minimum obligations reasonably required (A) for the JV to obtain and maintain Approval for the Combination Product in the Territory, (B) for Gilead, to sell the Combination Product on behalf of the JV, to perform its obligations with respect to pricing and discounting of the Combination Product pursuant to Section 5.3A, the [ * ] Section 5.3B and the [ * ] and (C) for each Member Party to supply to the JV bulk active pharmaceutical ingredient pursuant to Section 4 and the applicable Supply Agreement, (ii) the Commercialization Plan and Budget (including any minimum Commercialization expenditures and/or [ * ] shall terminate, and (iii) each Member Party shall have the right to Promote, Market and otherwise commercialize the Combination Product in the Territory without coordination with the other Member Party under this Agreement (including, without any obligation to reach agreement on the form of Approved Marketing Materials).

15.5 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to the rules of conflict of laws thereof.

15.6 Arbitration .

(a) Disputes between the Member Parties, or between a Member Party and the JV, relating to or arising out of the validity, interpretation or construction of, or the compliance with or breach of, this Agreement, the Operating Agreement, any Ancillary

 

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Agreement or any other agreement contemplated by this Agreement to which such Member Party (or its Affiliates) and the JV and/or the other Member Party (or its Affiliates) are parties shall (except as otherwise expressly provided in this Agreement, the Operating Agreement, any Ancillary Agreement or any such other agreement) be referred initially to the JEC as provided in Section 2.8 and, if not resolved as so provided in Section 2.8, thereafter (subject to the limitations in Section 2.8) resolved exclusively through binding arbitration in accordance with the CPR Institute for Dispute Resolution Rules for Non-Administered Arbitration, to be held in Washington, D.C. In any proceeding between a Member Party and the JV, the other Member Party shall act on behalf of and in the name of the JV, and any external, out-of-pocket costs (without markup) so incurred by such other Member Party shall be deemed to be JV Expenses and Authorized Expenses. In any proceeding under this Section 15.6, there shall be one arbitrator, except that at the election of either Member Party in writing within ten (10) Business Days of receiving notice of such referral to arbitration, there shall be a panel of three (3) arbitrators. The Member Parties shall appoint such arbitrator(s) by mutual agreement or, if the Member Parties cannot agree on the appointment of such arbitrator(s) within thirty (30) days after receipt of a demand for arbitration, the Member Parties shall have the relevant number of arbitrators with the required qualifications appointed by the CPR Institute for Dispute Resolution, provided that if either Member Party has elected to have a panel of three arbitrators, each Member Party shall have the right to appoint one arbitrator with the required qualifications, and the third arbitrator shall be appointed by the CPR Institute for Dispute Resolution. Each arbitrator shall either have at least ten (10) years of significant management level experience in the biopharmaceutical industry including responsibility for legal matters or have at least ten (10) years of substantial experience as an attorney representing or working with biopharmaceutical clients as either in-house or outside counsel in commercial litigation or transactional matters, shall not be directly or indirectly affiliated with either Member Party or with either Member Party’s Affiliates, and shall not have any direct or indirect interest of any kind in the resolution of the relevant issue. This Section 15.6 shall also apply to any dispute properly referred to arbitration in accordance with Section 2.8 or Section 13.8(g) hereof or Section 6.5(d) of the Operating Agreement (with respect to the JEC).

(b) Any fees and expenses payable with respect to an arbitration under this Section 15.6, together with the reasonable legal fees of the prevailing Party, shall be borne by the non-prevailing Party, as determined by the arbitrator(s). All arbitration rulings and awards shall be final and binding on the Parties.

(c) Any dispute referred to binding arbitration pursuant to this Section 15.6 shall be scheduled for discovery, briefing and arguments by the arbitrator(s) so that the decision can be rendered within [ * ] (or as soon thereafter as practicable) after such referral. Each of the Member Parties shall submit to the arbitrator(s) a comprehensive proposal for resolution of the dispute (including, if the arbitration involves an allegation of breach by a Member Party of any of its obligations under this Agreement, the Operating Agreement, any Ancillary Agreement or any other agreement contemplated by this Agreement to which such Member Party (or its Affiliates) and the JV and/or the other Member Party (or its Affiliates) are parties, a proposal for damages), and the arbitrator(s) shall decide in favor of one of the two (2) proposals, without making any modifications thereto. The decision of the arbitrator(s) shall be

 

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based on which of the proposals complies most nearly with this Agreement, any relevant Development Plan(s) or Commercialization Plan(s), and any relevant principles reflected in such plans, including, without limitation, the Collaboration Principles.

(d) Nothing in this Agreement, including, without limitation this Section 15.6, shall preclude either Member Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a dispute with the other Member Party, either prior to or during the dispute resolution procedures set forth in this Section 15.6, if necessary to protect the interests of such Member Party. This Section 15.6(d) shall be specifically enforceable.

15.7 Waiver . A Party’s failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy, does not constitute a waiver of such provision, right or remedy, or prevent such Party thereafter from enforcing any or all provisions and exercising any or all other rights and remedies. The exercise of any right or remedy does not constitute an election or prevent the exercise of any or all rights or remedies, all rights and remedies being cumulative.

15.8 Severability . If any provision of this Agreement, other than the obligation of the JV to make payments pursuant to Section 7.1(a), should be held invalid, illegal or unenforceable in any respect, then, to the fullest extent permitted by Applicable Law, (a) all other provisions hereof shall remain in full force and effect and shall be liberally construed in order to carry out the intent of the Parties as nearly as may be possible, and (b) the Parties agree to use their best efforts to negotiate a provision, in replacement of the provision held invalid, illegal or unenforceable, that is consistent with Applicable Law and accomplishes, as nearly as possible, the original intention of the Parties with respect thereto. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof prohibited or unenforceable in any respect.

15.9 Counterparts . This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of which, taken together, shall constitute one and the same instrument.

15.10 Construction . Except where the context otherwise requires, wherever used the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders. The words “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement (including the Annexes hereto) as an entirety and not to any particular provision. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. Any reference in this Agreement to a matter or action being subject to the “mutual agreement” or “mutual consultation” of the Member Parties, or words of similar import, shall not be construed as an agreement that the Member Parties shall agree to such matter or action. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party.

 

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15.11 Status of the Parties . Except as set forth expressly in this Agreement or in the Operating Agreement, no Party shall have the right to enter into any agreements or take action on behalf of any other Party, nor shall it represent to any Person that it has any such right or authority. Except for the status of BMS Sub and Gilead Sub as members of the JV, nothing in this Agreement shall be construed as establishing a partnership or joint venture relationship between the Parties. Each Member Party shall be made a third party beneficiary of all Ancillary Agreements to which the other Member Party is a party, for the purpose of enforcing the JV’s rights thereunder.

15.12 Standstill . During the period commencing on the Effective Date and continuing until the fifth anniversary of the Effective Date, BMS shall not, and shall cause the Affiliates of BMS not to:

(a) acquire, or offer or agree to acquire, directly or indirectly, beneficial ownership of any equity securities of Gilead, or any rights or options to acquire such beneficial ownership, or otherwise act in concert with respect to any such securities, rights or options with any Person;

(b) make, or participate in, directly or indirectly, any “solicitation” of “proxies” to vote (as such terms are used in the Regulation 14A promulgated under the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”)), become a “participant” in any “election contest” (as such terms are defined in Rule 14a-11 promulgated under the Exchange Act) or initiate, propose or otherwise solicit stockholders of Gilead for the approval of any stockholder proposals;

(c) form, join, participate in, or encourage the formation of, a group (within the meaning of Section 13(d)(3) of the Exchange Act) with respect to any voting securities of Gilead;

(d) deposit any securities of Gilead into a voting trust, or subject any securities of Gilead to any agreement or arrangement with respect to the voting of such securities;

(e) make any public announcement with respect to, or submit a proposal for, or offer (with or without conditions) of any extraordinary transaction involving Gilead or any of its securities or assets;

(f) seek, or encourage or support any effort, to influence or control the management, Board of Directors, business, or policies of Gilead (it being understood and agreed that this Section 15.12(f) shall not apply to the exercise by BMS of any of its rights and obligations under this Agreement, the Operating Agreement and the Ancillary Agreements as applicable);

(g) encourage or assist any other Person to undertake any of the foregoing actions; or

 

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(h) take any action that could reasonably be expected to require Gilead to make a public announcement regarding the possibility of any of the events described in clauses (a) through (g) of this Section 15.12;

provided , however , that nothing in Sections 15.12(a), (e) or (g) shall be deemed to prohibit BMS from acquiring (i) by merger or stock purchase of more than fifty percent (50%) of the voting securities thereof, a Third Party that has beneficial ownership of equity securities of Gilead (or rights or options to acquire such beneficial ownership) or (ii) beneficial ownership of up to five percent (5%) of any class of equity securities of Gilead (or rights or options to acquire such beneficial ownership) by or through (1) an employee benefit plan of BMS or any of its Affiliates, (2) a diversified mutual or pension fund managed by an independent investment adviser or pension plan established for the benefit of the employees of BMS or its Affiliates, or (3) any stock portfolios not controlled by BMS or any of its Affiliates that invest in Gilead or any of its Affiliates among other companies; provided that BMS or any of its Affiliates does not, directly or indirectly, request the trustee or administrator or investment adviser of such fund, plan or portfolio to acquire Gilead equity securities; and provided , further , that this Section 15.12 shall be of no further effect and shall not bind BMS in any manner from and after such time, if any, as Gilead shall make a public announcement that it has entered into a letter of intent or definitive agreement with a Third Party Acquirer providing for a Change of Control of Gilead.

15.13 Nonsolicitation of Employees . During the period commencing on the Effective Date and continuing through the term of this Agreement, each Member Party agrees that neither it nor any of its Affiliates that participates in or is responsible for the Development or Commercialization of the Combination Product pursuant to this Agreement shall recruit, solicit or induce any employee of the other Member Party’s, or any of its Affiliates’, HIV/Virology Sales Force (including managers) who is employed in the Territory to terminate his or her employment with such other Member Party or its Affiliate and become employed by or consult for such other Member Party or its Affiliate, whether or not such employee is a full-time employee of such other Member Party or its Affiliate, and whether or not such employment is pursuant to a written agreement or is at-will. For purposes of the foregoing, “recruit,” “solicit” or “induce” shall not be deemed to mean (x) general solicitations by Third Party placement specialists or firms (e.g., headhunters) or (y) other general solicitations of employment (including responses to general advertisements), in each case ((x) and (y)) not specifically targeted at employees of a Party or any of its Affiliates.

15.14 Entire Agreement . This Agreement (including the Annexes hereto), together with the Operating Agreement, the Ancillary Agreements and the other agreements contemplated by this Agreement (including without limitation the SDEA), constitutes, on and as of the Amended Effective Date, the entire agreement of the Parties with respect to the subject matter hereof, and all prior or contemporaneous understandings or agreements, whether written or oral, between the Parties with respect to such subject matter (including the Mutual Technology Transfer Agreement entered into by Bristol-Myers Squibb Company and Gilead Sciences, Inc. as of February 5, 2004 (the “MTTA”) and the Mutual Confidential Disclosure Agreement entered into by and between Bristol-Myers Squibb Company and Gilead Sciences, Inc. as of December 12, 2003, as amended) are hereby superseded in their entireties; provided ,

 

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however , that any rights and obligations of the Parties under the MTTA and such Mutual Confidential Disclosure Agreement that have accrued as of the Effective Date shall survive. This Agreement shall not be amended in any respect whatsoever except by a further agreement, in writing, fully executed by each of the Parties (or prior to the Effective Date, by Gilead and BMS). Amendment of this Agreement shall be without prejudice to any rights that shall have accrued to the benefit of a Party hereunder prior to such amendment.

15.15 Consent to Jurisdiction . Each Party, for the purpose of enforcing an award under Section 15.6 or for seeking injunctive or other equitable relief as permitted by Section 12.8, 14.4(d) or 15.6(d), (a) irrevocably submits to the non-exclusive jurisdiction of the United States District Court for the District of Columbia (the “Court”), for purposes of any action, suit or other proceeding arising out of this Agreement, the Operating Agreement and any Ancillary Agreement, and (b) agrees not to raise any objection at any time to the laying or maintaining of the venue of any such action, suit or proceeding in any of such Court, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such Court does not have any jurisdiction over such Party. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Party’s notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in the Court with respect to any matters to which it has submitted to jurisdiction in this Section 15.15.

15.16 Third Parties . Except as set forth in Sections 13.5, 13.6, and 13.7 as to those Third Parties expressly referred to therein, the agreements, covenants and representations contained herein are for the benefit of the Parties only and are not for the benefit of any Third Parties.

[ * ]

 

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IN WITNESS WHEREOF, the Parties have caused this Amended and Restated Collaboration Agreement to be duly executed and delivered as of the date first above written.

 

GILEAD SCIENCES, INC.       BRISTOL-MYERS SQUIBB COMPANY
By:   

/s/ John F. Milligan, Ph.D

      By:   

/s/ Tamar Howson

   John F. Milligan, Ph.D          Tamar Howson
   Executive Vice President and Chief Financial Officer         

Senior Vice President,

Corporate and Business Development

GILEAD HOLDINGS, LLC       E.R. SQUIBB & SONS, L.L.C.
By:   

/s/ John F. Milligan, Ph.D

      By:   

/s/ David Bonk

   John F. Milligan, Ph.D          David Bonk
   President          Assistant Secretary
BRISTOL-MYERS SQUIBB & GILEAD SCIENCES, LLC      
By Gilead Holdings, LLC, its Member         
By:   

/s/ John F. Milligan, Ph.D

        
   John F. Milligan, Ph.D         
   President         
By E.R. Squibb & Sons, L.L.C., its Member         
By:   

/s/ David Bonk

        
   David Bonk         
   Assistant Secretary         

 

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ANNEXES TO COLLABORATION AGREEMENT

Annex A – Initial Committee Members and Alliance Managers

Annex B – Development Plan and Development Budget as of Effective Date

Annex C – U.S. Commercialization Plan and U.S. Commercialization Budget as of Effective Date

Annex D – BMS Patents in the U.S.

Annex E – Gilead Patents in the U.S.

Annex F – Gilead Licensed Trademarks

Annex G – BMS Licensed Trademarks

Annex H – Quarterly Detail Report

Annex I – Manner of Calculation of Net Selling Price

Annex J – Calculation of Cost of Goods

Annex K – Calculation of Transfer Price

Annex L – Joint Press Release Following Effective Date

Annex M – Certain Financial Data

Annex N – Data to be Provided to Independent Accounting Expert Pursuant to Section 7.1

Annex O – JV Obligations as Sublicensee

Annex P1 – Key Terms of Services Agreement

Annex P2 – Key Terms of Canada Distribution and Supply Agreement; Structure Schematic

Annex Q1 – [ * ] Pricing [ * ]

Annex Q2 – [ * ] Pricing [ * ]

Annex R – List of Countries Comprising the Developing World

Annex S – BMS Patents in Canada

Annex T – Gilead Patents in Canada

Annex U – Canadian Commercialization Plan and Canadian Commercialization Budget as of Amended Effective Date

Annex V – Development Plan and Development Budget for Canada

Annex W – Joint Press Release Following Amended Effective Date

 

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Annex A – Initial Committee Members and Alliance Managers

 

GILEAD SUB

 

BMS SUB

Joint Executive Committee (JEC)

  Joint Executive Committee (JEC)

[ * ]

  [ * ]

[ * ]

  [ * ]

[ * ]

  [ * ]

Joint Development Committee (JDC)

  Joint Development Committee (JDC)

[ * ]

  [ * ]

[ * ]

  [ * ]

[ * ]

  [ * ]

[ * ]

  [ * ]

Joint Commercialization Committee (JCC)

  Joint Commercialization Committee (JCC)

[ * ]

  [ * ]

[ * ]

  [ * ]

[ * ]

  [ * ]

[ * ]

  [ * ]

Joint Finance Committee (JFC)

  Joint Finance Committee (JFC)

[ * ]

  [ * ]

[ * ]

  [ * ]

Alliance Manager

  Alliance Manager

[ * ]

  [ * ]

* denotes initial chairperson

 

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Annex B – Development Plan and Development Budget as of Effective Date

[ * ]

 

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CONFIDENTIAL

Annex C – Commercialization Plan and Commercialization Budget as of Effective Date

Annex C

Commercialization Plan and Budget

Sustiva/Viread/Emtriva Fixed Dose Combination

[ * ]

 

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Annex D – BMS Patents

 

  Patents exclusively licensed by BMS from Merck

 

   [ * ]

 

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Annex E – Gilead Patents

 

  [ * ]

 

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Annex F – Gilead Licensed Trademarks

 

Country

 

Mark

 

App. / Reg. No.

 

Filing / Reg. Date

 

Class

USA

  TRUVADA   2,915,213   12/28/2004   5

USA

  VIREAD   2,586,295   06/25/2002   5

USA

  EMTRIVA   2,852,092   06/08/2004   5

Canada

  TRUVADA   1226501   08/10/2004   5

Canada

  VIREAD   TMA577635   03/19/2003   5

Canada

  EMTRIVA   1192398   10/14/2003   5

 

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Annex G – BMS Licensed Trademarks

 

Country

 

Mark

 

App./Reg. No.

 

Filing/Reg. Date

 

Class

U.S.

  SUSTIVA   2,496,476   10/9/2001   5

Puerto Rico

  SUSTIVA   39883   2/28/97   5

Canada

  SUSTIVA   TMA495846   6/10/1998  

Canada

  SUSTIVA & SUNRISE LOGO   TMA561198   5/1/2002  

 

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Annex H – Quarterly Detail Report

For illustrative purposes only

[ * ]

 

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Annex I – Manner of Calculation of Net Selling Price

The Net Selling Price for a product for a relevant period for a country shall be expressed in dollars per daily dose for such product and shall be equal to the quotient of (i) the aggregate Net Sales for such country of such product for such period that are recognized as revenue (under United States generally accepted accounting principles in effect from time to time, as consistently applied), divided by (ii) the number of daily doses of such product in units for which revenue may be recognized (under United States generally accepted accounting principles in effect from time to time, as consistently applied) for such period that may be sold or used [ * ] in such country plus the number of daily doses of such product in [ * ] for such country shipped during such period, provided, however, that consistent with the definition of Net Sales, [ * ]. The Parties’ intent is that the practices of BMS and Gilead in calculation of Net Sales shall be harmonized in the process of calculating Net Selling Price, such that (a) any deductions, payments, rebates or other compensations made or given by BMS or Gilead in connection with or in respect of sales of such products shall be treated as a deduction from gross amount invoiced in the calculation of Net Sales, and (b) if both BMS and Gilead make payments or provide other compensation for a similar purpose with respect to a product but only one of them treats that item for accounting purposes as a deduction from revenues, then for purposes of calculation of Net Selling Price under this Annex I that item shall be a deduction from gross amount invoiced in the calculation of Net Sales for both parties.

Example:

[ * ]

 

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Annex J – Calculation of Cost of Goods

“Cost of Goods” means with respect to manufacture or acquisition of a product, an amount equal to [ * ] The calculation of Cost of Goods for specific products will be mutually agreed in writing by the Members and updated for each Calendar Year.

 

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Annex K – Calculation of Transfer Price

[ * ]

 

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Annex L – Joint Press Release

 

Bristol-Myers Squibb Contacts   Gilead Sciences Contacts
David Rosen, Media   Amy Flood, Media
(609) 252-5675   (650) 522-5643
John Elicker, Investors   Susan Hubbard, Investors
(212) 546-3775   (650) 522-5715

BRISTOL-MYERS SQUIBB AND GILEAD SCIENCES ESTABLISH

JOINT VENTURE TO DEVELOP AND COMMERCIALIZE

FIXED-DOSE COMBINATION OF THREE HIV MEDICINES

First Collaboration to Develop a Once-Daily Antiretroviral Fixed-Dose Regimen

New York, NY and Foster City, CA, DATE, 2004 – Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced details of a joint venture to develop and commercialize the fixed-dose combination of Bristol-Myers Squibb’s Sustiva ® (efavirenz) and Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) in the United States. If approved, the new product would be the first complete Highly Active Antiretroviral Therapy (HAART) treatment regimen for HIV available in a fixed-dose combination taken once daily. Fixed-dose combinations contain multiple medicines formulated together and may help simplify HIV therapy for patients and providers. The joint venture established by the two companies is the first of its kind in the field of HIV therapy.

The work necessary to co-formulate Sustiva and Truvada into a once-daily combination product has been ongoing throughout most of 2004 and will continue into 2005. Through the joint venture – Bristol-Myers Squibb & Gilead Sciences, LLC – the companies will work in partnership to complete development and U.S. regulatory filings for this fixed-dose regimen. Subject to receiving marketing approval of the fixed-dose regimen, the companies would share responsibility for commercializing the product in the United States. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. Bristol-Myers Squibb and Gilead will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the fixed-dose combination.

Guidelines issued by the U.S. Department of Health and Human Services (DHHS) list the combination of emtricitabine, tenofovir disoproxil fumarate and efavirenz as one of the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI)-based treatments for use in appropriate patients that have never taken anti-HIV medicines before. It is important that patients be aware that individual HIV medications must be taken as part of combination regimens, and that they do not cure HIV infection or prevent passing HIV to others.

 

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“Gilead and Bristol-Myers Squibb share a steadfast commitment to addressing the needs of people living with HIV/AIDS around the world, and today’s announcement signals significant progress toward our common goal,” commented John C. Martin, PhD, president and chief executive officer, Gilead Sciences. “This landmark partnership reflects the dedication Gilead and Bristol-Myers Squibb bring to delivering simplified therapy to physicians and patients. We look forward to working with the Bristol-Myers Squibb team to ensure this novel therapeutic advancement reaches physicians and people living with HIV/AIDS as rapidly as possible.”

“For more than a decade, Bristol-Myers Squibb has been a leader in the field of HIV with significant investments in innovative scientific research and an unwavering commitment to finding new and better treatment options to help improve the lives of people with HIV,” said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb Company. “We are pleased to be leveraging our leadership in HIV through this collaboration with Gilead to help advance the management of the disease through the development of potentially more convenient treatment options.”

Earlier in 2004, U.S. Secretary of Health and Human Services Tommy Thompson addressed the need for new products to help advance and simplify treatment for people with HIV/AIDS, encouraging members of industry to work together to create fixed-dose combinations that would help achieve these goals. Additionally, earlier this year the U.S. Food and Drug Administration issued new guidelines to expedite the approval of new combination products for HIV.

“The availability of simplified treatment regimens for HIV/AIDS is important to our ability to make progress in the fight against the disease,” Secretary Thompson said. “I am pleased to see the collaboration and efforts of Bristol-Myers Squibb and Gilead. This partnership to create a fixed-dose combination of three HIV medications represents an important advance in our collective effort to deliver simplified therapy for people living with HIV.”

Important Safety Information About Sustiva

Sustiva is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1). Sustiva does not cure HIV or help prevent passing HIV to others.

Sustiva should not be taken with Hismanal ® (astemizole), Propulsid ® (cisapride), Versed ® (midazolam), Halcion ® (triazolam), ergot medicines (for example, Wigraine ® and Cafergot ® ), or Vfend ® (voriconazole). This list of medicines is not complete. Patients should discuss all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations (particularly St. John’s wort) they are taking or plan to take with their healthcare provider. Patients taking Sustiva should tell their doctor right away if they have any side effects or conditions including: severe depression, strange thoughts, or angry behavior, which have been reported in a small number of patients. A few reports of suicide have been made, but it is not known if Sustiva was the cause. Patients should tell their doctor if they have a history of mental illness or are using drugs or alcohol. Dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams are common. These feelings tend to go away after taking Sustiva for a few weeks.

Women should not become pregnant or breastfeed while taking Sustiva. Rash is a common side effect that usually goes away without any change in treatment. Rash may be a serious problem in some children. If a child develops a rash, their doctor should be contacted right away. Patients should tell their

 

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doctor if they have liver disease, have ever had seizures, or are taking medicine for seizures as tests to check the liver or drug levels in the blood may be needed. Changes in body fat have been seen in some patients taking HIV medicines, however, the cause and long-term effects of these changes are not known at this time. Other common side effects include: tiredness, upset stomach, vomiting and diarrhea. Taking Sustiva with food increases the amount of medicine in the body, which may increase the frequency of side effects. Sustiva should be taken on an empty stomach, preferably at bedtime, which may make some side effects less bothersome. United States Full Prescribing Information is available at www.sustiva.com .

About Truvada

Truvada combines Emtriva ® (emtricitabine) and Viread ® (tenofovir disoproxil fumarate) in one tablet taken once a day in combination with other antiretroviral agents. In the United States, Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. Safety and efficacy studies using Truvada tablets or using Emtriva and Viread in combination are ongoing.

Both components of Truvada have been studied individually, as part of multi-drug regimens and have been found to be safe and effective. Since Emtriva and lamivudine (3TC) are comparable in their structure, resistance profiles, and efficacy and safety as part of multi-drug regimens, existing data from the use of lamivudine and Viread in combination have been extrapolated to support use of Truvada tablets for the treatment of HIV-1 infection in adults. Therefore, in treatment-naïve patients, Truvada should be considered as an alternative to the combination of Viread and lamivudine for those patients who might benefit from a once-daily regimen. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

There are no study results demonstrating the effect of Truvada on clinical progression of HIV-1, and it is not recommended that Truvada be used as a component of a triple nucleoside regimen.

Truvada should not be used with Emtriva or Viread, or other drugs containing lamivudine, including Combivir ® , Epivir ® , Epivir-HBV ® , Epzicom or Trizivir ® . Two-hundred eighty-three patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor or protease inhibitor for 24 to 48 weeks in ongoing clinical studies. Based on these limited data, no new patterns of adverse events were identified and there was no increased frequency of established toxicities. For additional safety information about Emtriva or Viread in combination with other antiretroviral agents, please see “About Emtriva” and “About Viread,” below.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Viread, Emtriva and Truvada are not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of these drugs has not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread or Emtriva. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Viread, Emtriva or Truvada and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Changes in body fat have been observed in patients taking Viread, Emtriva, Truvada and other anti-HIV medicines. The cause and long term health effect of these conditions are unknown.

 

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About Viread

In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of Viread in treatment-naïve adults and in treatment-experienced adults. There are no study results demonstrating the effect of Viread on clinical progression of HIV-1. The use of Viread should be considered for treating adult patients with HIV-1 strains that are expected to be susceptible to tenofovir as assessed by laboratory testing or treatment history.

Drug interactions have been observed when didanosine, atazanavir or lopinavir/ritonavir is co-administered with Viread and dose adjustments may be necessary. Data are not available to recommend a dose adjustment of didanosine for patients weighing less than 60 kg. Patients on atazanavir or lopinavir/ritonavir plus Viread should be monitored for Viread-associated adverse events which may require discontinuation. When co-administered with Viread, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Viread.

Renal impairment, including serious cases, has been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The clinical significance of changes in BMD and biochemical markers is unknown and follow-up is continuing to assess long-term impact. The most common adverse events and those occurring in more than 5 percent of patients receiving Viread with other antiretroviral agents in clinical trials include asthenia, pain, abdominal pain, headache, nausea, diarrhea, vomiting, rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash and pustular rash), flatulence, dizziness and depression. Less than 1 percent of patients discontinued participation because of gastrointestinal events.

About Emtriva

In the United States, Emtriva is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies of 48 weeks duration in antiretroviral-naïve patients and antiretroviral-treatment-experienced patients who were virologically suppressed on an HIV treatment regimen. In antiretroviral-treatment-experienced patients, the use of Emtriva may be considered for adults with HIV strains that are expected to be susceptible to Emtriva as assessed by genotypic or phenotypic testing.

Adverse events that occurred in more than 5 percent of patients receiving Emtriva with other antiretroviral agents in clinical trials include abdominal pain, asthenia (weakness), headache, diarrhea, nausea, vomiting, dizziness and rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash, pustular rash and allergic reaction). Approximately 1 percent of patients discontinued participation because of these events. All adverse events were reported with similar frequency in Emtriva and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the Emtriva treated group. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. For more than a decade, Bristol-Myers Squibb Company has been a global leader in the science of infectious diseases and has invested consistently in innovative research leading to the development of important treatments for people with HIV/AIDS. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com .

 

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About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has seven marketed products and focuses its research and clinical programs on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in North America, Europe and Australia. Visit Gilead on the World Wide Web at www.gilead.com.

Forward-Looking Statements

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Among other risks, there can be no guarantee that the combination product will be submitted for regulatory approval, will receive regulatory approval, or, if approved, will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K/A for the year ended December 31, 2003 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Gilead Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements regarding approval and licensure of the combination product. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements, including the risks related to the ability of the companies to successfully complete ongoing studies to support approval of the combination product and the willingness of regulatory authorities to grant regulatory approval for the combination product based on data from those studies. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Gilead undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Gilead’s business, particularly those mentioned in the cautionary statements in the company’s Form 10-K for the year ended December 31, 2003, and in periodic reports on Form 10-Q and Form 8-K.

 

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Annex M – Certain Financial Data

 

    Annual Budget Reports: [ * ]

 

    Quarterly Projection Reports: (No later [ * ]

 

    Weekly Sales Reports by [ * ]

Actual Reports: (all times based on [ * ]

 

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Annex N – Data to be Provided to Independent Accounting Expert Pursuant to Section 7.1

To be provided by BMS on an annual basis:

[ * ]

To be provided by Gilead on an annual basis:

[ * ]

To be provided by the JV (or its designee) on an annual basis:

[ * ]

 

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Annex O – JV Obligations as Sublicensee

[ * ]

 

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Annex P1 – Key Terms of Services Agreement

This term sheet focuses on certain key aspects of the Services Agreement. It does not discuss all the terms and conditions that would be included in the definitive Services Agreement to be entered into by the JV and Gilead Parent pursuant to Section 5.2 of the Collaboration Agreement.

1. Agreement : Distribution Services Agreement (“Services Agreement”) between the JV and Gilead Parent, pursuant to which Gilead Parent will provide certain distribution services for the Combination Product in the Territory on behalf of the JV.

2. Distribution Services : Distribution services to be provided by Gilead Parent on behalf of the JV will include, without limitation,

 

  Inventory management and control:
    [ * ]

 

  Warehousing and storage:
    [ * ]

 

  Orders:
    [ * ]

 

  Invoicing; collection of sales proceeds:
    [ * ]

 

  Customer relations and services; returns:
    [ * ]

The JCC will oversee Gilead Parent’s activities under the Services Agreement.

Gilead Parent will provide the distribution services in accordance with customary practice in the biopharmaceutical industry, as well as with GSP, GMP and applicable law.

3. Compensation :

 

  [ * ]

4. Term :

The Services Agreement will continue for the term of the Collaboration Agreement, unless earlier terminated in accordance with Article 14 of the Collaboration Agreement.

 

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5. Miscellaneous :

The Services Agreement will contain additional provisions relating to matters such as [ * ] and such other provisions, consistent with the provisions of the Collaboration Agreement, upon which BMS and Gilead Parent mutually agree.

 

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FOR INFORMATIONAL PURPOSES ONLY

Annex P2 – Key Terms of Agreement for Canada Distribution

These terms cover certain key aspects of the distribution and supply agreement to be entered into between the JV and Gilead Parent. It does not discuss all the terms and conditions that would be included in such agreement.

1. Agreement : Canada Distribution and Supply Agreement (“CDSA”) between the JV and Gilead Parent, pursuant to which Gilead Parent will provide certain distribution activities for the Combination Product in Canada on behalf of the JV.

2. Distribution : Distribution activities to be provided by Gilead Parent or its contractors under agreement with the JV will include, without limitation,

 

  Inventory management and control:
   [ * ]

 

  Warehousing and storage:
   [ * ]

 

  Orders:
   [ * ]

 

  Invoicing; collection of sales proceeds:
   [ * ]

 

  Customer relations and services; returns:
   [ * ]

The JCOC will oversee Gilead Parent’s activities under the CDSA.

Gilead Parent will provide product distribution in accordance with customary practice in the biopharmaceutical industry, as well as with GSP, GMP and applicable law.

3. Compensation, Payment and Risk of Loss :

 

  [ * ]

4. Term :

The CDSA will continue for the term of the Amended and Restated Collaboration Agreement with respect to Canada, unless earlier terminated in accordance with Article 14 of the Amended and Restated Collaboration Agreement.

 

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FOR INFORMATIONAL PURPOSES ONLY

5. Miscellaneous :

The CDSA will contain additional provisions relating to matters such as [ * ] and such other provisions, consistent with the provisions of the Amended and Restated Collaboration Agreement, upon which the JV and Gilead Parent shall mutually agree.

[ * ]

 

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Annex Q1 –

[ * ]

 

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Annex Q2 –

[ * ]

 

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Annex R – List of Countries Comprising the Developing World

African Countries:

 

Algeria   Gabon   Nigeria
Angola   Gambia   Republic of Congo
Benin   Ghana   Rwanda
Botswana   Guinea   São Tomé and Príncipe
Burkina Faso   Guinea-Bissau   Senegal
Burundi   Kenya   Seychelles
Cameroon   Lesotho   Sierra Leone
Cape Verde   Liberia   Somalia
Central African Republic   Libya   South Africa
Chad   Madagascar   Sudan
Comoros   Malawi   Swaziland
Côte d’Ivoire   Mali   Tanzania
Democratic Republic of Congo   Mauritania   Togo
Djibouti   Mauritius   Tunisia
Egypt   Morocco   Uganda
Equatorial Guinea   Mozambique   Zambia
Eritrea   Namibia   Zimbabwe
Ethiopia   Niger  

Non-African Countries on the United Nations List of Least Developed Countries:

 

Afghanistan   Iran, Islamic Rep. of   Saudia Arabia
Antigua and Barbuda   Iraq   Solomon Islands
Bahamas   Jamaica   Sri Lanka
Bangladesh   Jordan   St. Vincent and the Grenadines
Barbados   Kiribati   Suriname
Belize   Laos   Syrian Arab Republic
Bhutan   Lebanon   Timor-Leste
Bolivia   Maldives   Trinidad and Tobago
Cambodia   Mongolia   Tonga
Cuba   Myanmar   Tuvalu
Dominica   Naura   Vanuatu
Dominican Republic   Nepal   Vietnam
El Salvador   Nicaragua   Yemen
Fiji   Oman  
Grenada   Pakistan  
Guatemala   Papua New Guinea  
Guyana   Philippines  
Haiti   Saint Kitts and Nevis  
Honduras   Saint Lucia  
Indonesia   Samoa  

 

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Annex S – BMS Patents in Canada

[ * ]

 

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Annex T – Gilead Patents in Canada

[ * ]

 

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Annex U

[ * ]

 

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Annex V –

[ * ]

 

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Annex W – Joint Press Release Following Amended Effective Date

 

LOGO   LOGO
Bristol-Myers Squibb Contacts   Gilead Sciences Contacts
Eric Miller, Media   James Loduca, Media
(609) 252-7981   (650) 522-5908
Marc Osborne, Media   Susan Hubbard, Investors
(514) 333-2463   (650) 522-5715
John Elicker, Investors  
(212) 546-3775  

For Immediate Release

BRISTOL-MYERS SQUIBB AND GILEAD SCIENCES ESTABLISH AGREEMENT

TO COMMERCIALIZE ATRIPLA (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir

disoproxil fumarate 300 mg) IN CANADA

If Approved, Product Would Be the First Once-Daily Single Tablet Regimen for HIV-1 Infection in Adults in Canada

Princeton, N.J. and Foster City, Calif., September 28, 2006 – Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement to commercialize ATRIPLA TM (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in Canada for the treatment of HIV-1 infection in adults, subject to the approval of the product by Health Canada. ATRIPLA is the first once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. ATRIPLA received approval from the U.S. Food & Drug Administration on July 12, 2006.

The agreement is the result of negotiations between Bristol-Myers Squibb and Gilead Sciences and expands the companies’ U.S. joint venture established in December 2004. The companies will work together to complete regulatory filings in Canada and will share responsibility for commercializing ATRIPLA in Canada, subject to regulatory approval of the product. As in the United States, both companies will provide funding and field-based sales representatives in support of promotional efforts for ATRIPLA. Gilead will record revenues from future net sales of ATRIPLA, while Bristol-Myers Squibb will record revenues at percentages relative to the contribution represented by its individual product.

“We are pleased to have finalized our agreement for Canada, and are working expeditiously to complete the regulatory filing for ATRIPLA with Health Canada,” said John C. Martin, PhD, President and CEO, Gilead Sciences. “We recognize the need for access to ATRIPLA, the first once-daily single tablet regimen, and are working to make it available to all patients who need it as quickly as possible.”

 

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“This agreement with Gilead Sciences marks an important step forward in our efforts to deliver effective HIV therapies,” said Lamberto Andreotti, president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. “We look forward to working with Gilead Sciences and Health Canada to make available another effective treatment option for Canadian adult patients living with HIV/AIDS.”

ATRIPLA combines SUSTIVA ® (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada ® (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences. Truvada itself is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread ® (tenofovir disoproxil fumarate) and Emtriva ® (emtricitabine), in a single once-daily tablet for use as part of combination therapy.

Important Safety Information About ATRIPLA, Truvada, Viread and Emtriva

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. ATRIPLA, Truvada, Viread and Emtriva are not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of these drugs have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread (components of ATRIPLA and Truvada). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue ATRIPLA, Truvada, Emtriva or Viread and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Additional Important Information About ATRIPLA

In the United States, ATRIPLA is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

It is important for patients to be aware that ATRIPLA does not cure HIV infection or AIDS. ATRIPLA has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.

ATRIPLA is contraindicated for use with astemizole, cisapride, midazolam, triazolam, ergot derivatives, or voriconazole. Concomitant use of ATRIPLA and St. John’s wort ( Hypericum perforatum ) or St. John’s wort-containing products is not recommended. Since ATRIPLA contains efavirenz, emtricitabine and tenofovir disoproxil fumarate, it should not be coadministered with SUSTIVA, Emtriva, Viread, or Truvada. Due to similarities between emtricitabine and lamivudine, ATRIPLA should not be coadministered with drugs containing lamivudine, including Combivir ® , Epivir ® , Epivir-HBV ® , Epzicom , or Trizivir ® .

Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%) and manic reactions (0.2%) have been reported in patients treated with efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included a history of injection drug use, psychiatric history and use of psychiatric

 

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medication. There have been occasional postmarketing reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if efavirenz was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits. Fifty-three percent of patients reported central nervous system symptoms including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%) and hallucinations (1.2%) when taking efavirenz compared to 25% of patients receiving control regimens. These symptoms usually begin during the first or second day of therapy and generally resolve after the first two to four weeks of therapy. After four weeks of therapy, the prevalence of central nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing efavirenz. Nervous system symptoms are not predictive of the less frequent psychiatric symptoms.

ATRIPLA should not be given to patients with creatinine clearance below 50 mL/min. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir disoproxil fumarate, most often in patients with underlying systemic or renal disease, or in patients taking concomitant nephrotoxic agents. Some cases have occurred in patients with no identified risk factors. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent.

ATRIPLA may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed while taking ATRIPLA. Barrier contraception must always be used in combination with other methods of contraception such as oral or other hormonal contraceptives. If the patient becomes pregnant while taking ATRIPLA, she should be apprised of the potential harm to the fetus.

Mild to moderate rash is a common side effect of efavirenz. In controlled clinical trials, 26% of patients treated with efavirenz experienced new-onset skin rash compared with 17% of patients treated in control groups. Skin discoloration, associated with emtricitabine, may also occur. ATRIPLA should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Liver enzymes should be monitored in patients with known or suspected hepatitis B or C and when ATRIPLA is administered with ritonavir or other medications associated with liver toxicity. Decreases in bone mineral density have been seen with tenofovir disoproxil fumarate. Use ATRIPLA with caution in patients with a history of seizures. Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures. Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA.

Coadministration of ATRIPLA and atazanavir is not recommended due to concerns regarding decreased atazanavir concentrations. Patients on lopinavir/ritonavir plus ATRIPLA should be monitored for tenofovir-associated adverse events. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse events. Coadministration of ATRIPLA and didanosine should be undertaken with caution. Patients receiving this combination should be monitored closely for didanosine-associated adverse events. See full prescribing information for complete list of drug-drug interactions.

 

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In a large controlled clinical trial (Study 934), adverse events observed in greater than or equal to 5% of patients in the Viread/Emtriva/SUSTIVA group include dizziness, nausea, diarrhea, fatigue, headache, and rash.

The dose of ATRIPLA is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.

Important Information About SUSTIVA

SUSTIVA (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA.

Coadministration with astemizole, cisapride, midazolam, triazolam, ergot derivatives, or voriconazole is contraindicated. Concomitant use of SUSTIVA and St. John’s wort ( Hypericum perforatum ) or St. John’s wort-containing products is not recommended. This list of medications is not complete.

Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%) and manic reactions (0.2%) have been reported in patients treated with SUSTIVA. In addition to SUSTIVA, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included history of injection drug use, psychiatric history, and use of psychiatric medication. There have been occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if SUSTIVA was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits. Fifty-three percent of patients reported central nervous system symptoms including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%) and hallucinations (1.2%) when taking SUSTIVA compared to 25% of patients receiving control regimens. These symptoms usually begin during Days 1-2 of therapy and generally resolve after the first 2-4 weeks of therapy. After four weeks of therapy, the prevalence of central nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing SUSTIVA. Nervous system symptoms are not predictive of the less frequent serious psychiatric symptoms.

SUSTIVA may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed while taking SUSTIVA. Barrier contraception must always be used in combination with other methods of contraception (e.g. oral or other hormonal contraceptives). If the patient becomes pregnant while taking SUSTIVA, she should be apprised of the potential harm to the fetus.

Mild to moderate rash is a common side effect of SUSTIVA. In controlled clinical trials, 26% of patients treated with SUSTIVA experienced new-onset skin rash compared with 17% of patients treated in control groups. SUSTIVA should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Rash is more common and often more severe in pediatric patients.

 

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Liver enzymes should be monitored in patients with known or suspected hepatitis B or C, in patients treated with other medications associated with liver toxicity, and when SUSTIVA is administered with ritonavir. Use SUSTIVA with caution in patients with a history of seizures. Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures. Redistribution and/or accumulation of body fat have been seen in patients receiving antiretroviral therapy. A causal relationship has not been established. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including SUSTIVA.

It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. The increased concentrations following administration of SUSTIVA with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms.

Additional Important Information About Truvada

Truvada is a fixed-dose combination product that combines 200 mg of Emtriva ® (emtricitabine) and 300 mg of Viread ® (tenofovir disoproxil fumarate) in one tablet, taken once a day. In the United States, Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. Truvada should not be coadministered with Emtriva, Viread or lamivudine-containing products and it is not recommended that Truvada be used as a component of a triple nucleoside regimen. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

Clinical Study 934 supports the use of Truvada tablets for the treatment of HIV-1 infection. Additional data in support of the use of Truvada are derived from Study 903, in which Viread and lamivudine were used in combination in treatment-naïve adults, and clinical Study 303, in which Emtriva and lamivudine demonstrated comparable efficacy, safety and resistance patterns as part of multidrug regimens.

No drug interaction studies have been conducted using Truvada. Drug interactions have been observed when didanosine, atazanavir, or lopinavir/ritonavir are co-administered with Viread, a component of Truvada, and dose adjustments may be necessary. Data are not available to recommend a dose adjustment of didanosine for patients weighing less than 60 kg. Patients on atazanavir or lopinavir/ritonavir plus Truvada should be monitored for Truvada-associated adverse events that may require discontinuation. When co-administered with Truvada, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Truvada.

Four-hundred and forty-seven HIV-1 infected patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor (Study 934) or protease inhibitor for 48 weeks in clinical studies. Adverse events observed in Study 934 were generally consistent with those seen in other studies in treatment-experienced or treatment-naïve patients receiving Viread and/or Emtriva. Adverse events observed in more than 5% of patients in the Viread/Emtriva group in Study 934 include diarrhea, nausea, fatigue, headache, dizziness and rash.

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported among patients taking Viread, a component of Truvada (emtricitabine and tenofovir disoproxil fumarate). Renal impairment

 

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occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy including Truvada, Viread and Emtriva.

The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, has been reported with the use of Emtriva, a component of Truvada. Skin discoloration was generally mild and asymptomatic and its mechanism and clinical significance are unknown.

The parent compound of Viread was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. Visit Gilead on the World Wide Web at www.gilead.com.

Forward-Looking Statements

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the combination product will receive regulatory approval in Canada or other geographies, or, if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Gilead Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including that the combination product receive regulatory approval in Canada or other geographies, or, if approved, that physicians may not see advantages of ATRIPLA over other

 

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antiretrovirals and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2005, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.

###

U.S full prescribing information for ATRIPLA is available at www.atripla.com.

U.S. full prescribing information for SUSTIVA is available at www.bms.com.

U.S. full prescribing information for Truvada, Viread and Emtriva is available at

www.gilead.com.

ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company.

Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc.

 

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Exhibit 10.3

SIXTH AMENDMENT AGREEMENT

This Sixth Amendment Agreement, effective as of August 18, 2006 (the “Effective Date”), is entered into by and between the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic, having offices at Flemingovo nam. 2, 166 10 Praha 6, Czech Republic (“ IOCB ”); and the K. U. Leuven Research and Development (representing the REGA Institute for Medical Research, Leuven), having offices at Groot Begijnhof 59, B-3000 Leuven, Belgium (“ REGA ”) ( IOCB and REGA hereinafter collectively referred to as “ IOCB/REGA ”) on one side and Gilead Sciences, Inc., a Delaware, USA corporation, having offices at 333 Lakeside Drive, Foster City, California 94404, U.S.A. (“ Gilead ”), on the other side. In this Sixth Amendment Agreement IOCB, REGA and GILEAD are sometimes referred to individually as a “Party” and collectively as the “Parties”.

WITNESSETH:

WHEREAS, the Parties have entered into the License Agreement dated effective November 15, 1991 (the “ 1991 License Agreement ”), relating to N-phosphonylmethoxyalkyl purines and pyrimidines and analogues including HPMPC as well as acyclic nucleotide analogues and other compounds; the License Agreement dated effective October 15, 1992 (the “ 1992 License Agreement ”), relating to N-(3-fluoro-2-phosphonomethoxypropyl) derivatives of heterocyclic bases; and the License Agreement dated effective December 1, 1992 (the “ 1992 PMPA License Agreement ”), relating to (R) PMPA and (R) PMPDAP and other compounds. The 1991 License Agreement, the 1992 License Agreement, and the 1992 PMPA License Agreement are referred to collectively as the “ License Agreements ”; and

WHEREAS, the License Agreements were first amended by the Amendment Agreement dated effective October 25, 1993; and further amended by Annex 1 on April 1, 1997, by Annex 2 on March 20, 2002, and by the Letter Agreement dated April 8, 2002 (the “ First Amendment Agreement ”); and

WHEREAS, the 1991 License Agreement was subsequently amended by the Second Amendment Agreement dated effective January 1, 1996 (the “ Second Amendment Agreement ”); and further amended by the Third Amendment Agreement dated effective April 23, 2002 (the “ Third Amendment Agreement ”); and the License Agreements were further amended by the Fourth Amendment Agreement dated effective August 1, 2004 (the “ Fourth Amendment Agreement ”), and by the Fifth Amendment Agreement dated effective January 1, 2006 (the “ Fifth Amendment Agreement ”);

WHEREAS, the 1991 License Agreement and the 1992 PMPA License Agreement were further amended by the Letter Agreement dated effective December 26, 2000, as amended on December 27, 2000 (the “ December 2000 Letter Agreement ”); and


WHEREAS, the Parties now desire to amend the License Agreements, as previously amended, in order to further clarify certain payment provisions related thereto;

NOW, THEREFORE, the Parties agree as follows:

 

  1. All capitalized terms used in this Sixth Amendment Agreement but not defined herein shall have the meaning assigned in the License Agreements, as amended.

 

  2. The royalty obligations set forth in Sections IV A(b), IV A(c), IV B and IV C of the 1992 PMPA License Agreement, as amended in Section 4 of the December 2000 Letter Agreement, and as further amended in Sections 1.3(a), (b) and (c) of the Fourth Amendment Agreement, shall only apply to sales by Gilead, its AFFILIATES and sublicensees of LICENSED COMPOUND or LICENSED PRODUCT, including any COMBINATION PRODUCT, in each case containing Tenofovir (as defined in the December 2000 Letter Agreement) (each hereinafter a “ PRODUCT ”), in the countries set forth in Exhibit A (the “ HIGH-INCOME TERRITORY ”), and shall be payable for the term set forth therein.

 

  3. With respect to sales by Gilead, its AFFILIATES and sublicensees of PRODUCT in all countries of the world other than those in the HIGH-INCOME TERRITORY, the royalty obligations set forth in Sections IV A(b), IV A(c), IV B and IV C of the 1992 PMPA License Agreement, Section 4 of the December 2000 Letter Agreement, and Section 1.3 of the Fourth Amendment Agreement, are hereby amended as follows:

 

  a. Except as set forth in Section 3(c) below, with respect to sales of PRODUCT by Gilead, its AFFILIATES and sublicensees sold for end use in the countries set forth in Exhibit B (the “ UPPER MIDDLE INCOME AND LOWER-MIDDLE INCOME TERRITORY ”), Gilead will pay to IOCB/REGA a royalty of three percent (3%)  of the gross amount received by Gilead from any third party in consideration for the sale of such PRODUCT. For purposes of this Section 3(a), “gross amount received” shall include, but shall not be limited to, (i) Gilead’s NET SALES for direct sales of PRODUCT by Gilead, or (ii) the total amount received by Gilead, in the form of a royalty, transfer price or other means of payment, for sales of PRODUCT by Gilead’s distributors and sublicensees, as appropriate.

 

  b. With respect to sales of PRODUCT in final finished form for administration to end users (“FINISHED PRODUCT”) manufactured by Indian generic companies under a license from Gilead (each an “Indian Company”) and sold in India and/or the countries set forth in Exhibit C (the “ ACCESS COUNTRIES ”), Gilead will pay to IOCB/REGA a royalty of twenty percent (20%)  of the gross amount received by Gilead from any such Indian Company in consideration for the sale of such FINISHED PRODUCT.

 

2


  c. With respect to sales of PRODUCT in the ACCESS COUNTRIES by Gilead, Merck, Sharp & Dohme, Aspen Pharmacare, or their respective AFFILIATES, or any other entity with whom Gilead enters into similar no-profit or minimum-profit arrangements in the ACCESS COUNTRIES, no royalties shall be payable to IOCB/REGA. Any future arrangements in the ACCESS COUNTRIES, other than such no-profit or minimum-profit arrangements, which result in a royalty obligation from Gilead to IOCB/REGA will be discussed on a case-by-case basis, and any such royalty obligation will be determined upon mutual agreement of the Parties.

 

  d. The payments by Gilead as required under Section 3(a) and (b) of this Sixth Amendment Agreement shall be payable to IOCB/REGA commencing on the Effective Date of this Sixth Amendment Agreement and shall continue until the expiration of the last to expire LICENSED PATENT a VALID CLAIM of which would be infringed but for the License Agreements, as amended.

 

  e. Gilead shall provide to IOCB/REGA copies of all sublicenses or other agreements (i) under which Gilead receives payment as described in Section 3(a) or (b) of this Sixth Amendment Agreement, or (ii) which fall within the scope of agreements described in Section 3(c) of this Sixth Amendment Agreement.

 

  4. The territories set forth in each of the exhibits attached hereto may be modified from time to time as appropriate. Countries that are not listed on the exhibits attached hereto as of the Effective Date may be added from time to time by Gilead, provided, however, that Gilead will not assign any such added country to one of the territories defined in the attached exhibits using a method other than through the “gross national income per capita” formula that Gilead used to create the defined territories as of the Effective Date. Gilead may also reassign a country from one defined territory to another if such a reassignment is justified using such “gross national income per capita” formula. Any deviation from such formula, or other circumstance that results in a different allocation of countries into the defined territories, will be subject to mutual written agreement between the Parties.

 

  5. Gilead agrees that at all times it shall carry out its obligations under this Sixth Amendment Agreement in good faith and that it shall not enter into any arrangement intended to allow Gilead to evade or reduce its obligations to IOCB/REGA set forth in this Sixth Amendment Agreement.

 

3


  6. Except as expressly provided in this Sixth Amendment Agreement, the License Agreements, as amended, shall remain in full force and effect according to their terms.

IN WITNESS WHEREOF , the parties hereto have caused this Sixth Amendment Agreement to be executed by their respective duly authorized representatives as of the Effective Date.

 

INSTITUTE OF ORGANIC CHEMISTRY

AND BIOCHEMISTRY AV CR

   

REGA INSTITUTE

FOR MEDICAL RESEARCH

By:  

 

    By:  

 

  Prof. Zdenek Havlas, Director       Prof. Erik De Clercq, President
Date:  

 

    Date:  

 

K.U. LEUVEN RESEARCH AND DEVELOPMENT     GILEAD SCIENCES, INC.
By:  

 

    By:  

 

  Prof. Koenraad Debackere, Director      

John F. Milligan, Ph.D.

Executive Vice President & CFO

Date:  

 

    Date:  

 

By:  

 

     
  Paul VAN DUN, Director      
Date:  

 

     

 

4


Exhibit A

The HIGH-INCOME TERRITORY

 

1.   Australia    27.   Latvia
2.   Austria    28.   Lithuania
3.   Bahrain    29.   Luxembourg
4.   Belgium    30.   Macedonia, TFYR
5.   Bosnia & Herzegovina    31.   Malta
6.   Brunei Darussalam    32.   Netherlands
7.   Bulgaria    33.   New Zealand
8.   Canada    34.   Norway
9.   Croatia    35.   Poland
10.   Cyprus    36.   Portugal
11.   Czech Republic    37.   Qatar
12.   Denmark    38.   Romania
13.   Estonia    39.   Saudi Arabia
14.   Finland    40.   Singapore
15.   France    41.   Slovakia
16.   Germany    42.   Slovenia
17.   Greece    43.   Spain
18.   Hong Kong    44.   Sweden
19.   Hungary    45.   Switzerland
20.   Iceland    46.   Turkey
21.   Ireland    47.   United Arab Emirates
22.   Israel    48.   United Kingdom
23.   Italy    49.   United States
24.   Japan     
25.   Korea, Republic of     
26.   Kuwait     

 

5


Exhibit B

The UPPER MIDDLE-INCOME TERRITORY

 

1. Argentina
2. Brazil
3. Chile
4. Colombia
5. Costa Rica
6. Lebanon
7. Malaysia
8. Mexico
9. Oman
10. Panama
11. Uruguay
12. Venezuela

The LOWER MIDDLE-INCOME TERRITORY

 

1. Albania
2. Algeria
3. Armenia
4. Azerbaijan
5. Belarus
6. China
7. Ecuador
8. Egypt
9. El Salvador
10. Fiji
11. Georgia
12. Iran, Islamic Rep. of
13. Jordan
14. Kazakhstan
15. Libya
16. Morocco
17. Paraguay
18. Peru
19. Philippines
20. Sri Lanka
21. Tonga
22. Tunisia
23. Turkmenistan

 

6


Exhibit C

The ACCESS COUNTRIES

 

1.   Afghanistan    34.   Guatemala    67.   Saint Lucia
2.   Angola    35.   Guinea    68.   Saint Vincent & the Grenadines
3.   Antigua and Barbuda    36.   Guinea-Bissau    69.   Samoa
4.   Bahamas    37.   Guyana    70.   Sao Tome and Principe
5.   Bangladesh    38.   Haiti    71.   Senegal
6.   Barbados    39.   Honduras    72.   Seychelles
7.   Belize    40.   Indonesia    73.   Sierra Leone
8.   Benin    41.   Jamaica    74.   Solomon Islands
9.   Bhutan    42.   Kenya    75.   Somalia
10.   Bolivia    43.   Kiribati    76.   South Africa
11.   Botswana    44.   Kyrgyzstan    77.   Sudan
12.   Burkina Faso    45.   Lao, People’s Dem. Rep.    78.   Surinam
13.   Burundi    46.   Lesotho    79.   Swaziland
14.   Cambodia    47.   Liberia    80.   Syria
15.   Cameroon    48.   Madagascar    81.   Tajikistan
16.   Cape Verde    49.   Malawi    82.   Tanzania, U. Rep. of
17.   Central African Republic    50.   Maldives    83.   Thailand
18.   Chad    51.   Mali    84.   Timor-Leste
19.   Comoros    52.   Mauritania    85.   Togo
20.   Congo    53.   Mauritius    86.   Trinidad and Tobago
21.   Congo, Dem. Rep. of the    54.   Moldova, Rep. of    87.   Tuvalu
22.   Cote d’ivoire    55.   Mongolia    88.   Uganda
23.   Cuba    56.   Mozambique    89.   Uzbekistan
24.   Djibouti    57.   Myanmar    90.   Vanuatu
25.   Dominica    58.   Namibia    91.   Vietnam
26.   Dominican Republic    59.   Nepal    92.   Yemen
27.   Equatorial Guinea    60.   Nicaragua    93.   Zambia
28.   Eritrea    61.   Niger    94.   Zimbabwe
29.   Ethiopia    62.   Nigeria     
30.   Gabon    63.   Pakistan     
31.   Gambia    64.   Papua NewGuinea     
32.   Ghana    65.   Rwanda     
33.   Grenada    66.   Saint Kitts and Nevis     

 

7

Exhibit 10.4

RESTRICTED STOCK AWARD AGREEMENT

Restricted Stock Award #<<Restricted Shares>>«NUM»

«First_Name» «Middle_Name» «Last_Name», Grantee:

GILEAD SCIENCES, INC. (the “Company”), pursuant to its 2004 Equity Incentive Plan, as amended (the “Plan”) and this Restricted Stock Award Agreement (the “Agreement”), has this day granted to you, the grantee named above (“Grantee”), an award of Restricted Stock (“Restricted Stock Award”) consisting of shares of the common stock of the Company (the “Common Stock”), subject to the terms and conditions set forth in this Agreement and otherwise provided in the Plan. Any terms not defined herein shall have the meaning set forth in the Plan.

The details of your Restricted Stock Award are as follows:

1. The total number of shares of Common Stock subject to this Restricted Stock Award is «Restricted Shares_Granted» of Common Stock (the “Restricted Shares”). Subject to the limitations contained herein, the Restricted Shares shall vest and no longer be subject to forfeiture as described in the vesting schedule, below:

 

Restricted Shares   Vesting Event   
[insert]   [insert]   

The Restricted Shares shall vest as follows: [insert] .

[Notwithstanding the foregoing, the Restricted Shares granted to a Grantee who qualifies as a Covered Employee will not vest until a Committee (or subcommittee) which is comprised solely of two or more Directors eligible to serve on a committee making Awards qualifying as Performance-Based Compensation has determined that the performance goals set forth above have been satisfied.]

2. Consideration of not less than the par value of the Company’s Common Stock, or $0.001 per share, has been paid by you to the Company for the Restricted Stock Award in the form of services rendered.

3. In the event a fractional portion of a Restricted Share vests, such fractional Restricted Share will be rounded down to the nearest whole number.

4. Notwithstanding anything to the contrary contained herein, you may not sell the Restricted Shares unless the Restricted Shares are then registered under the US Securities Act of 1933, as amended (the “Act”) or, if such Restricted Shares are not then so registered, the Company has determined that such sale would be exempt from the registration requirements of the Act.

5.    (a)  The Restricted Shares shall be issued by the Company and registered in your name on the stock transfer books of the Company. Such Restricted Shares shall remain in the physical custody of the Company or its designee at all times through the applicable Vesting Event and the lapse of the risk of forfeiture as specified in the vesting schedule, above.

(b) By accepting this Restricted Stock Award, you agree that the Company may require you to enter an arrangement providing for the payment by you to the Company of any federal, state or local tax or social security withholding obligation of the Company or a Related Entity arising by reason of (i) the grant of this Restricted Stock Award; (ii) the vesting and lapse of the risk of forfeiture to which the Restricted Shares are subject; (iii) payment of any dividends; or (iv) the sale of Restricted Shares following their vesting.

(c) To the extent that you are subject to U.S. federal income tax, you hereby acknowledge that you may file an election pursuant to Section 83(b) of the Code to be taxed currently on the fair market value of the Restricted Shares (less any purchase price paid for the Restricted Shares), provided that such election must be filed with the Internal Revenue Service no later than thirty (30) days after the grant of your Restricted Stock Award. You should seek the advice of your tax advisors as to the advisability of making such a Section 83(b) election, the potential consequences of making such an election, the requirements for making such an election, and the other tax consequences of the Restricted Stock Award under federal, state, and any other laws that may be applicable. The Company and its Related Entities and their agents have not and are not providing any tax advice to you.

 

1


6. Subject to the restrictions set forth in the Plan and this Agreement, you shall possess all the rights and privileges of a shareholder of the Company while the Restricted Stock Award is subject to stop-transfer instructions, or otherwise held by the Company or its designee, including the right to vote and to receive dividends (if any).

7. The Restricted Stock Award and any interest therein may not be transferred, except by will or by the laws of descent and distribution, when the Restricted Shares are unvested. Any attempt to transfer any unvested Restricted Shares shall be null and void and without effect.

8. The term of this Restricted Stock Award commences on the date hereof and, unless sooner terminated as set forth in this Agreement or in the Plan, terminates on «Expiration_Date» (the “Expiration Date”).

Provided you remain in Continuous Active Service with the Company or a Related Entity (as described in Section 2(o) of the Plan), the Restricted Shares shall vest according to the vesting schedule, above. For purposes of facilitating the enforcement of the provisions of this paragraph, the Company may issue stop-transfer instructions on the Restricted Shares to the Company’s transfer agent, or otherwise hold the Restricted Shares, until the Restricted Shares have vested and you have satisfied all applicable tax and social security withholding obligations set forth in paragraph 5, above. Once you have satisfied such obligations, you are free to sell or otherwise dispose of the Restricted Shares.

In the event of termination of your Continuous Active Service (as described in Section 2(o) of the Plan) with the Company or a Related Entity for a reason other than death, disability or a Change in Control (as defined in the Plan) before the date on which a Vesting Event occurs or before the Expiration Date, whichever is earlier, any unvested Restricted Shares as of the date your Continuous Active Service ceases shall be automatically forfeited by you as of the date of termination, unless:

(a) such termination of Continuous Active Service is due to your permanent and total disability (as determined by the Company in its sole discretion), in which event the Restricted Stock Award shall terminate on the earlier of the Expiration Date set forth above or twelve (12) months following such termination of Continuous Active Service; or

(b) such termination of Continuous Active Service is due to your death, in which event the Restricted Stock Award shall terminate on the earlier of the Expiration Date set forth above or twelve (12) months after your death.

If this Restricted Stock Award does not vest pursuant to the Vesting Event within the twelve (12) month or such earlier period described in subsections 8(a) and (b) above, the Restricted Stock Award shall be forfeited.

9. This Agreement is not an employment or service contract and nothing in this Agreement shall be deemed to create in any way whatsoever any obligation on your part to continue in the service of the Company or a Related Entity, or of the Company or a Related Entity to continue your service with the Company or the Related Entity. In the event that this Restricted Stock Award is granted to you in connection with the performance of services as a consultant or a director, references to employment, employee and similar terms shall be deemed to include the performance of services as a consultant or a director, as the case may be, provided, however, that no rights as an employee shall arise by reason of the use of such terms.

10. Any notices provided for in this Agreement or the Plan shall be given in writing and shall be deemed effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the address specified below or at such other address as you hereafter designate by written notice to the Company.

11. This Agreement is subject to all the provisions of the Plan, a copy of which is attached hereto and its provisions are hereby made a part of this Agreement, including without limitation the provisions of Sections 5, 6, 7, and 8 of the Plan relating to Restricted Stock Award provisions, and is further subject to all interpretations, amendments, rules and regulations which may from time to time be promulgated and adopted pursuant to the Plan. In the event of any conflict between the provisions of this Agreement and those of the Plan, the provisions of the Plan shall control.

12. This Agreement and the Plan set forth all of the rights and liabilities with respect to this Restricted Stock Award.

13. This Agreement shall be governed by, and subject to, the law of the State of California, without resort to that State’s conflict of law rules. For purposes of litigating any dispute that arises directly or indirectly from the relationship of the parties evidenced by the Restricted Stock Award, the parties hereby submit to and consent to the exclusive jurisdiction of the State of California and agree that such litigation shall be conducted only in the courts of San Mateo County, California, or the federal courts for the United States for the Northern District of California, and no other courts, where this grant is made and/or to be performed.

 

2


14. This Agreement is the entire understanding between the Grantee and the Company and its Related Entities regarding the acquisition of shares of Common Stock in the Company and supersedes all prior oral and written agreements on that subject with the exception of any Awards previously granted to the Grantee under the Plan, the Company’s 1987 Stock Purchase Plan, the Company’s 1987 Incentive Stock Option Plan, the Company’s 1987 Supplemental Stock Option Plan, the Company’s 1991 Stock Option Plan, the Company’s 1995 Non-Employee Directors’ Stock Option Plan, the rights to purchase stock granted to the Grantee under the Company’s 1991 Employee Stock Purchase Plan or any Awards originally granted to the Grantee under the Vestar, Inc. 1988 Stock Option Plan, the NeXstar Pharmaceuticals, Inc. 1993 Incentive Stock Plan, the Triangle Pharmaceuticals, Inc. 1996 Stock Incentive Plan or the Corus Pharma, Inc. 2001 Stock Plan.

Dated «Restricted Stock Award_Date»

 

Very truly yours,

GILEAD SCIENCES, INC.

By:  

 

  John C. Martin
  President and CEO

ATTACHMENT :

2004 Equity Incentive Plan

 

3

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

E XHIBIT 10.5

DEVELOPMENT AND LICENSE AGREEMENT

BY AND BETWEEN

GILEAD SCIENCES, INC.

AND

F. HOFFMANN-LA ROCHE LTD

AND

HOFFMANN-LA ROCHE INC.

SEPTEMBER 27, 1996


A RTICLE  1.   D EFINITIONS    1
        1.1   “Affiliate”    1
        1.2   “Budget”    2
        1.3   “Cost of Goods Sold”    2
        1.4   “Cover”    2
        1.5   “Development Costs”    2
        1.6   “Development Plan”    3
        1.7   “European Union”    3
        1.8   “First Commercial Sale”    3
        1.9   “Generically Equivalent Product”    3
        1.10   “Gilead Know-How”    3
        1.11   “Gilead Patent Rights”    3
        1.12   “IND” (or “Investigational New Drug Application”)    3
        1.13   “Joint Patent Rights”    4
        1.14   “NDA” (or “New Drug Application”)    4
        1.15   “Net Sales”    4
        1.16   “Phase III Clinical Trial”    5
        1.17   “Product(s)”    5
        1.18   “Proprietary Information”    5
        1.19   “Roche Know-How”    5
        1.20   “Roche Patent Rights”    5
        1.21   “Steering Committee”    6
        1.22   “Third Party”    6
        1.23   “Third Party Royalties”    6
        1.24   “Valid Claim”    6
A RTICLE  2.   G RANT OF R IGHTS    6
        2.1   License Grant.    6
        2.2   Sublicensing.    6
        2.3   Right of First Refusal.    6
        2.4   Gilead Sublicenses.    7
        2.5   Disclosure of Gilead Know-How.    7
        2.6   Related Technology.    7
A RTICLE 3.   D EVELOPMENT AND R EGULATORY A FFAIRS    8
        3.1   Steering Committee.    8
        3.2   Clinical Development and Regulatory Filings.    9
        3.3   Development Costs.    10
        3.4   Adverse Reactions.    11
A RTICLE 4.   D UE D ILIGENCE    12
        4.1   Due Diligence.    12

 

i


        4.2   Global Commercial Roll-Out.    12
        4.3   Commercial Due Diligence.    12
        4.4   Reports.    13
A RTICLE  5.   C OMPENSATION    14
        5.1   License Fee    14
        5.2   Milestone Payments.    14
        5.3   Royalty Payments; Adjustments.    15
        5.4   Sublicense.    18
        5.5   Payment Structure.    19
A RTICLE  6.   M ANUFACTURING    19
        6.1   Pre-Commercial Manufacturing.    19
        6.2   Commercial Manufacturing.    19
A RTICLE 7   M ARKETING    20
        7.1   Pricing.    20
        7.2   Use of The Gilead Name.    20
A RTICLE 8.   P AYMENTS ; R ECORDS ; A UDIT    20
        8.1   Payment; Report.    20
        8.2   Exchange Rate; Manner and Place of Payment.    20
        8.3   Records and Audit.    21
        8.4   Withholding Taxes.    22
A RTICLE 9.   T ERM AND T ERMINATION    22
        9.1   Term.    22
        9.2   Licenses upon Expiration.    22
        9.3   Termination for Breach.    22
        9.4   Termination for Gilead’s Breach.    23
        9.5   Product Reversion.    23
        9.6   Termination by Roche For Convenience.    23
        9.7   Survival.    24
A RTICLE  10.   I NTELLECTUAL P ROPERTY    24
        10.1   Ownership of Inventions.    24
        10.2   Prosecution of Patents.    24
        10.3   Infringement of Patents by Third Parties.    26
        10.4   Infringement of Third Party Rights.    27
        10.5   Patent Marking.    28
A RTICLE  11.   I NDEMNIFICATION    28
        11.1   Indemnification by Gilead.    28

 

ii


        11.2   Indemnification by Roche.    28
        11.3   Mechanics.    29
        11.4   Insurance Coverage.    29
A RTICLE  12.   C ONFIDENTIALITY    30
        12.1   Proprietary Information; Exceptions.    30
        12.2   Authorized Disclosure    31
        12.3   Return of Proprietary Information.    31
        12.4   Publications.    32
A RTICLE 13.   R EPRESENTATIONS AND W ARRANTIES    32
        13.1   Mutual Representations and Warranties.    32
        13.2   Gilead Representations and Warranties.    33
        13.3   No Other Representations.    33
A RTICLE 14.   D ISPUTE R ESOLUTIONS ; V ENUE AND G OVERNING L AW    33
        14.1   Disputes.    33
        14.2   Alternative Dispute Resolution.    34
        14.3   Arbitration Procedure.    35
        14.4   Judicial Enforcement.    36
        14.5   Governing Law.    36
A RTICLE  15.   M ISCELLANEOUS    36
        15.1   Agency.    36
        15.2   Assignment.    36
        15.3   Amendment.    36
        15.4   Notices.    37
        15.5   Force Majeure.    38
        15.6   Affiliates.    38
        15.7   Export Control.    38
        15.8   Severability.    38
        15.9   Cumulative Rights.    38
        15.10   Waiver.    39
        15.11   Entire Agreement.    39

 

iii


DEVELOPMENT AND LICENSE AGREEMENT

T HIS D EVELOPMENT AND L ICENSE A GREEMENT (the “A GREEMENT ), dated as of September 27, 1996 (the “E FFECTIVE D ATE ), is made by and between G ILEAD S CIENCES , I NC . , a Delaware corporation ( “G ILEAD ), on the one hand, and F. H OFFMANN -L A R OCHE L TD , a corporation organized under the laws of Switzerland, and H OFFMANN -L A R OCHE I NC , a corporation organized under the laws of New Jersey, on the other hand (collectively, “R OCHE ).

B ACKGROUND

W HEREAS , Gilead has discovered and is developing a series of proprietary compounds which act as influenza neuraminidase inhibitors and may be effective in the prevention and treatment of influenza; and

W HEREAS , Roche, through its divisions and/or subsidiaries, is engaged in the development, production and commercialization of pharmaceuticals, but prior to the date of this Agreement has not established a research program in the area of influenza neuraminidase inhibition or discovered compounds which have such effect; and

W HEREAS , Gilead and Roche desire to enter into a development and license agreement for the worldwide development and marketing of influenza neuraminidase inhibitors for the prevention and treatment of influenza.

N OW , T HEREFORE , in consideration of the foregoing premises and the covenants and obligations set forth in this Agreement, the parties hereby agree as follows:

A RTICLE 1

D EFINITIONS

As used herein, the following terms will have the following meanings:

1.1 “Affiliate” means any entity that directly or indirectly Owns, is Owned by or is under common Ownership with, a party to this Agreement, where “Own” or “Ownership” means direct or indirect possession of at least fifty percent (50%) of the outstanding voting securities of a corporation or a comparable ownership in any other type of entity, provided, however, that if the law of the jurisdiction in which such entity operates does not allow fifty percent (50%) or greater ownership by a party to this

 

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Agreement, such ownership interest shall be at least forty percent (40%). The term Affiliate shall not include Genentech, Inc., 460 Point San Bruno Boulevard, South San Francisco, California, prior to the time Roche delivers notice to Gilead designating Genentech as its Affiliate.

1.2 “Budget” means the annual budget approved by the parties from time to time pursuant to Section 3.3(d).

1.3 “Cost of Goods Sold” means the manufacturing cost of Product sold by Roche, its Affiliates and sublicensees, calculated in accordance with reasonable cost accounting methods of such parties, provided that such methods comply with generally accepted accounting principles and the further provisions of this Section 1.3. Cost of Goods Sold shall consist of direct labor and materials and a reasonable allocation of indirect labor, facilities expense (including depreciation over the expected life of the buildings and equipment), and administration costs. Cost of Goods Sold shall exclude costs associated with process development, initial Product batches for regulatory approval, plant start-up costs, excess capacity, Third Party royalties, or any costs for which provision has been made in the definition of Net Sales. In the event of any transfer of Product among Roche, its Affiliates or sublicensees, the Cost of Goods Sold shall exclude any profit or other mark-up by any such parties.

1.4 “Cover” (including variations thereof such as “Covered,” “Coverage,” or “Covering”) shall mean that the manufacture, use or sale of a particular product would infringe a Valid Claim of an issued patent in the absence of rights under such patent. The determination of whether a product is Covered by particular patent rights shall be made on a country by country basis.

1.5 “Development Costs” mean the costs incurred by Gilead or for its account after the Effective Date which are consistent with the Development Plan and are specifically attributable to the development of Products. Such costs shall mean the direct costs and the indirect costs of all Gilead development personnel and any third party costs, all of them incurred to further the Product development program. Indirect costs related to the Development Plan shall include but not be limited to salaries, employee benefits, use of facilities and equipment, personnel, travel materials and supplies, which shall be absorbed into the Development Costs based on generally accepted accounting principles and methods approved by Roche, such approval not to be unreasonably withheld.

 

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1.6 “Development Plan” means the plan for the development of Products approved from time to time pursuant to Section 3.3. The initial Development Plan, reflecting the mutual objectives of the parties with respect to the sequence of events leading up to the filing of regulatory submissions, has been agreed to by the parties as of the Effective Date.

1.7 “European Union” or “EU” means the following countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal, Spain, Sweden, and the United Kingdom.

1.8 “First Commercial Sale” means the first sale, in any particular country, by Roche or its Affiliates or sublicensees of Product for use by the general public after required marketing and pricing approval has been granted by the governing health authority of that country.

1.9 “Generically Equivalent Product” shall mean a product marketed by a Third Party, not under license from Roche, which contains as an active ingredient an influenza neuraminidase inhibitor the composition of matter of which is within the scope of a Gilead Patent Right or a Joint Patent Right.

1.10 “Gilead Know-How” means all proprietary inventions, technology, trade secrets, clinical and preclinical results, and any physical, chemical or biological material, or other information excluding Gilead Patent Rights and Joint Patent Rights, owned or acquired with right to sublicense during the term of this Agreement by Gilead or any Affiliate of Gilead, which are necessary or useful to Roche in the development, formulation, manufacture, use or sale of Products.

1.11 “Gilead Patent Rights” mean the rights under patents and patent applications, both foreign and domestic, which (a) Cover an influenza neuraminidase inhibitor, or its manufacture, formulation or use, including intermediates for the manufacture or use thereof, (b) are based on an invention made at any time prior to the fifth anniversary of the Effective Date and (c) are owned by or licensed to Gilead or any Gilead Affiliate with the right to sublicense. Notwithstanding the foregoing, Gilead Patent Rights shall exclude Joint Patent Rights but shall include “Gilead Patents,” which are defined as those patents and patent applications owned by or licensed to Gilead or any Gilead Affiliate with the right to sublicense that are encompassed within Gilead Patent Rights. Set forth as Exhibit A is a list of the Gilead Patents as of the Effective Date. Such Exhibit shall be updated no more frequently than annually upon Roche’s request.

1.12 “IND” (or “Investigational New Drug Application”) means an application as defined in the United States Food, Drug and Cosmetic Act and applicable

 

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regulations promulgated thereunder to the United States Food and Drug Administration (the “FDA”) or the equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of Products in humans.

1.13 “Joint Patent Rights” mean the rights under patents and patent applications, both foreign and domestic, which (a) Cover an influenza neuraminidase inhibitor, or its manufacturing formulation or use, including intermediates for the manufacture or use thereof, (b) are based on an invention made at any time prior to the fifth anniversary of the Effective Date, and (c) are owned jointly by Gilead and Roche. Exhibit A shall be amended to include Joint Patents when such patent applications are first filed.

1.14 “NDA” (or “New Drug Application”) means an application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder to the United States FDA or the equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence commercial sale of Products.

1.15 “Net Sales” means the gross sales invoiced by Roche, its Affiliates or sublicensees for Product to Third Parties other than sublicensees, less deductions of returns (including withdrawals and recalls), rebates (price reductions, including Medicaid and similar types of rebates, e.g. chargebacks), volume (quantity) discounts, discounts granted at the time of invoicing, sales taxes and other taxes directly linked to and included in the gross sales amount as computed on a product by product basis for the countries concerned (hereinafter referred to as “Adjusted Gross Sales”).

From the Adjusted Gross Sales there shall be a lump sum deduction of [ * ] for those sales-related deductions which are not accounted for on a product by product basis (e.g., outward freights, transportation insurance, packaging materials for dispatch of goods, custom duties, discounts granted later than at the time of invoicing, cash discounts and other direct sales expenses).

In the case of Products being sold as part of a combination product containing the Product and one or more other therapeutically active ingredients, the parties shall negotiate an appropriate royalty adjustment to reflect the relative significance of each such ingredient, based on the estimated fair market value of each such therapeutically active ingredient.

 

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Notwithstanding the foregoing, amounts received by Roche or its Affiliates or sublicensees for the sale of Licensed Products among Roche and its Affiliates or sublicensees for resale shall not be included in the computation of Net Sales hereunder.

1.16 “Phase III Clinical Trial” means any clinical trial primarily designed to serve as a pivotal, well-controlled study upon which approval of an NDA will be based, including such a study referred to or denominated as a Phase II/III study in the United States or the equivalent elsewhere.

1.17 “Product(s)” means any pharmaceutical product containing an influenza neuraminidase inhibitor Covered by a Gilead Patent Right, a Roche Patent Right or a Joint Patent Right.

1.18 “Proprietary Information” means, subject to the limitations set forth in Section 12.1 hereof, all information disclosed by a party hereto to the other party pursuant to this Agreement. In particular, Proprietary Information shall be deemed to include, but is not limited to, information relating to research and development programs and results, therapeutic candidates and products, clinical and preclinical data, trade secrets, business strategy, patent applications, licenses, suppliers, manufacturers, product and marketing strategy, customers, market data, personnel and consultants.

1.19 “Roche Know-How” means all proprietary inventions, technology, trade secrets, clinical and preclinical results, and any physical, chemical or biological material, or other information excluding Roche Patent Rights and Joint Patent Rights, owned or acquired with right to sublicense during the term of this Agreement by Roche or any Affiliate of Roche, which are necessary or useful to Roche in the development, formulation, manufacture, use or sale of Products.

1.20 “Roche Patent Rights” means the rights under patents and patent applications, both foreign and domestic, which (a) Cover an influenza neuraminidase inhibitor, or its manufacture, formulation or use, including intermediates for the manufacture or use thereof, (b) are based on an invention made at any time prior to the fifth anniversary of the Effective Date, and (c) are owned by or licensed to Roche or any Roche Affiliate, with the right to sublicense. Notwithstanding the foregoing, Roche Patent Rights shall exclude Joint Patent Rights, but shall include “Roche Patents,” which are defined as those patents and patent applications owned by or licensed to Roche or any Roche Affiliate with the right to sublicense that are encompassed within Roche Patent Rights. Exhibit A shall be amended to include Roche Patents when such patent applications are first filed. Such Exhibit shall be updated no more frequently than annually upon Gilead’s request.

 

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1.21 “Steering Committee” means that committee comprised of an equal number of representatives of Gilead and Roche, but not less than two (2) representatives from each company, which shall have the responsibilities set forth in Section 3.1 and elsewhere in this Agreement.

1.22 “Third Party” means any person or entity other than Gilead, Roche or an Affiliate of either party hereto.

1.23 “Third Party Royalties” means any royalties or license fees owing to a Third Party attributable to the manufacture, use or sale of Products and in consideration of a license under any patent which such Product would otherwise infringe.

1.24 “Valid Claim” means a claim in the Gilead Patent Rights, the Roche Patent Rights, or the Joint Patent Rights, which has not been disclaimed or held invalid by a decision beyond the right of review or otherwise has been finally determined by a court of competent jurisdiction to be unenforceable.

A RTICLE 2

G RANT OF R IGHTS

2.1 License Grant. Subject to the terms of this Agreement, Gilead hereby grants to Roche and its Affiliates a sole and exclusive, worldwide license under the Gilead Patent Rights, Gilead’s interest in the Joint Patent Rights, and the Gilead Know-How only for the manufacture, importation, use, sale and offer for sale of Products for any and all uses. Roche agrees that the Gilead Patents and the Gilead Know-How will not be used for any other purpose.

2.2 Sublicensing. Except as otherwise provided in Section 2.3 below, Roche shall have the right to sublicense the rights granted under Section 2.1 to Third Parties. If Roche grants a sublicense, all of the terms and conditions of this Agreement shall apply to the sublicensee to the same extent as they apply to Roche for all purposes of this Agreement. Roche assumes full responsibility for the performance of all obligations so imposed on such sublicensee and will itself pay and account to Gilead for all royalties due under this Agreement by reason of the operations of any such sublicensee.

2.3 Right of First Refusal. In the event Roche desires to sublicense the rights granted pursuant to Section 2.1 above to any Third Party for commercialization in any of the following countries: the [ * ] Roche shall first present an offer to Gilead for such rights. Gilead and Roche shall negotiate such offer in good faith for at least [ * ] from the date the offer is received by Gilead; provided , however , that Roche shall not have an obligation to engage in such negotiations with respect to countries where Gilead has not

 

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established a sales force or committed to do so prior to the anticipated launch of the Product in such country. If, at the end of such [ * ] period, the parties have been unable to reach agreement on the essential terms of an agreement granting Product rights in such country or countries to Gilead, Roche shall be free to offer the rights to Products in such country or countries to any Third Party; provided, however, that Roche shall not make an offer more favorable to any such Third Party than the offer last made to Gilead by Roche without first giving Gilead at least [ * ] to consider and accept such more favorable offer.

2.4 Gilead Sublicenses. It is the understanding of the parties that the license granted to Roche in Section 2.1 includes any future technology which Gilead may acquire by license, with the right to sublicense, which is relevant to the activities defined in Section 2.1. In the event Gilead obtains under license from a Third Party technology the subject matter of which falls under the license granted herein, Gilead shall promptly advise Roche of such license and the terms which would be applicable to Roche in the event a sublicense is granted hereunder. Roche may decline to accept the sublicense in question. If, following such disclosure, Roche elects to receive such sublicense, then such technology shall automatically be sublicensed to Roche hereunder without further consideration to Gilead. In the event of any such sublicense, the terms of the agreement between Gilead and its licensor shall govern in the event of any inconsistency between such Third Party license agreement and this Agreement, and the rights granted to Roche herein shall be explicitly subject to such Third Party license agreement.

2.5 Disclosure of Gilead Know-How. Following the Effective Date and through the term of this Agreement, Gilead shall make available to Roche, subject to the terms of this Agreement, all Gilead Know-How.

2.6 Related Technology. Roche acknowledges that in consideration of the collaboration established hereby and the enabling nature of the work previously done by Gilead, any influenza neuraminidase inhibitors as to which Roche or its Affiliates acquires rights prior to the fifth anniversary of the Effective Date, whether by reason of their own efforts or under contract from Third Parties, shall be included within the definition of Products under this Agreement, subject to the terms and conditions hereof. Similarly, Gilead acknowledges that its license to Roche hereunder covers all of the influenza neuraminidase inhibitors as to which it has rights or acquires rights prior to the fifth anniversary of the Effective Date.

 

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A RTICLE 3

D EVELOPMENT AND R EGULATORY A FFAIRS

3.1 Steering Committee.

(a) Steering Committee Membership and Governance. The parties shall establish a Steering Committee to coordinate the activities of the parties with respect to Products. The Steering Committee in turn may establish such working groups or other mechanisms as it desires to achieve this result. Except to the extent otherwise provided in this Agreement, the responsibility of the Steering Committee for each Product in each country shall terminate following the initial commercial launch of such Product in such country. The Steering Committee shall consist of an equal number of representatives of each party, which shall be at least two (2). The size of the Steering Committee may be changed by agreement of the parties. Each party shall within thirty (30) days after the Effective Date select its initial members of the Steering Committee. Each party may select additional representatives to replace the initial Steering Committee members selected by such party as necessary during the term of the Agreement, and may have other representatives attend meetings of the Steering Committee in addition to the members of the committee. Any Steering Committee members selected by one party shall be subject to the reasonable approval of the other party. The Chairperson of the Steering Committee shall alternate annually between a representative of Gilead and a representative of Roche, with the initial Chairperson of the Steering Committee being appointed by Roche. The Chairperson of the Steering Committee shall be responsible for providing an agenda for each meeting of the committee at least ten (10) days in advance of such meeting and shall prepare written minutes of all committee meetings in reasonable detail. The Chairperson shall distribute such minutes to all members of the Steering Committee within twenty (20) days after the relevant meeting. The Steering Committee shall attempt to operate by consensus, and any issues that the Steering Committee is unable to resolve by consensus shall be submitted for resolution pursuant to Article 14 below.

(b) Steering Committee Meetings and Responsibilities. The Steering Committee shall meet at least two (2) times per year until the First Commercial Sale of a Product in any country, and thereafter as appropriate for the continued development and registration of Products. In addition, either party may request additional meetings as reasonably required. The Steering Committee shall be responsible for overseeing and monitoring the implementation of the Development Plan and the Budget. In particular, the Steering Committee will review and approve each annual Budget pursuant to Section 3.3. The Steering Committee shall also monitor the allocation of research and development work between the parties and shall recommend changes as

 

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necessary. The parties shall report to the Steering Committee on all significant clinical and regulatory issues relating to Products, and the Steering Committee shall make recommendations and provide strategic guidance with respect to such issues. The Steering Committee shall meet to review and approve a global clinical trial program prior to the conduct of any clinical trials, and shall review and approve the plans for any individual clinical trial of Product in advance of the anticipated commencement date thereof. Neither party shall commence any clinical trial of a Product until the Steering Committee has approved the plans therefor, provided , however , that such requirement for prior approval shall not apply to post-marketing clinical trials which are not directed towards a change in the labeling of the Product. In addition to its responsibilities related to research and development, the Steering Committee shall oversee manufacturing activities related to the Products and plans for the initial commercial launch and country-by-country roll out of Products, and Roche shall report to the Steering Committee in reasonable detail regarding its current and planned activities in these areas.

3.2 Clinical Development and Regulatory Filings.

(a) Clinical Development. The collaborative clinical development program will follow the most expeditious path to achieve global registration of Products with both parties playing a significant role in the execution of clinical development activities. Gilead will focus its efforts towards the conduct of clinical trials in the United States, and Roche will initially focus its efforts towards the conduct of clinical trials outside the United States. Both parties will contribute to the conduct of clinical trials as necessary to support the global program. The final distribution of responsibility will be the decision of the Steering Committee.

(b) Regulatory Filings. Gilead shall prepare and file in its own name the IND for Products in the United States. The IND in the United States will be transferred to Roche shortly before the commencement of Phase III registrational studies. The particular responsibility for filings, interactions with regulatory authorities and the appropriate time for transfer of regulatory responsibility to Roche will be decided by the Steering Committee. In any event, prior to the transfer of the IND in the United States, Roche shall receive copies of all material correspondence with the FDA and shall have the right to be present at all meetings with the FDA related to Products. Beginning at the time of transfer of ownership of the IND to Roche, Roche shall be primarily responsible with Gilead’s assistance for all regulatory affairs in the United States related to Products. In addition, Gilead shall either transfer ownership of, or provide Roche with letters of access to, any drug master files or other regulatory dossiers containing information necessary or useful to Roche in connection with its regulatory filings for Product, with the choice between transfer or providing letters of access to be made in the discretion of Gilead. In all countries, Gilead shall be entitled to receive copies of material

 

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correspondence with regulatory authorities, including filings made by Roche, with respect to Products, and Gilead shall have the right to be present at all meetings with regulatory authorities related to Products.

(c) Diligence. Roche and Gilead will each diligently carry out the global development of Products as provided in this Section 3.2, subject to the Budgets approved under Section 3.3(d). Without limitation of the foregoing, such efforts shall include the assignment of appropriate personnel and the allocation of sufficient resources to carry out such party’s responsibilities under the Development Plan.

3.3 Development Costs.

(a) General. Roche shall pay all its own research and development expenses in carrying out the Development Plan, as modified from time to time by the Steering Committee, and shall reimburse Gilead for all its Development Costs incurred pursuant to the Development Plan and the Budget in effect at the time.

(b) Audit Rights. Gilead shall keep complete and accurate records pertaining to the Development Costs incurred pursuant to this Agreement in sufficient detail to permit Roche to confirm the accuracy of such Costs. At Roche’s request, Gilead will cause its independent certified public accountants to prepare abstracts of Gilead’s relevant business records for review by Roche’s independent certified public accountants. If, based on a review of such abstracts, Roche reasonably believes that a full audit of said business records would be necessary for the confirmation of the accuracy of the Development Costs, Roche’s independent certified public accountants shall have full access to review all work papers and supporting documents pertinent to such abstracts, and shall have the right to discuss such documentation with Gilead’s independent certified public accountants. [ * ] Such audit rights may be exercised no more often than once a year, within three (3) years after the period to which such records relate, upon notice to Gilead and during normal business hours. Roche will bear the full cost of such audit unless such audit discloses an overpayment of Development Costs by Roche of more than five percent (5%) from the amount due. Gilead shall promptly refund any such overpayment. The terms of this Section 3.3(b) shall survive any termination or expiration of this Agreement for a period of three (3) years.

(c) Reimbursement of Prior Research Expenses. In addition to the payment of Development Costs as provided herein, Roche shall, within ten (10) days after the Effective Date, pay to Gilead the amount of five million dollars ($5,000,000) as reimbursement for research and preclinical development expenses incurred by Gilead with respect to Products prior to the Effective Date. Such payment shall be nonaccountable, nonrefundable, and noncreditable.

 

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(d) Budget. It is agreed between the parties that as of the Effective Date, the amount of [ * ] is the estimated budget for reimbursement to Gilead for its internal research and development efforts under the Development Plan during a period of [ * ] following the Effective Date. In addition, Gilead’s external expenses for such research and development will be reimbursed pursuant to the Budget and in accordance with Section 3.3(e). Within forty-five (45) days following the Effective Date, the Steering Committee shall adopt a Budget for all research and development activities anticipated for the period from the Effective Date through December 31, 1997. The Budget approved by the Steering Committee will replace the estimated budget for Gilead’s internal expenses referred to above. On or before October 1, 1997, and not later than October 1 of each subsequent calendar year during the term of this Agreement, the Steering Committee shall approve annual budgets for all research and development activities scheduled for the following calendar year; such annual budgets shall be consistent with the Development Plan, as modified from time to time by the Steering Committee. Upon approval, annual budgets shall be the Budget then in effect.

(e) Payments to Gilead; Reconciliation. Roche shall pay to Gilead the amount budgeted for Gilead’s Development Costs for each calendar quarter on or before the first day of such calendar quarter within [ * ] after receipt of an invoice from Gilead. Within [ * ] following the end of each such calendar quarter, Gilead shall provide an accounting to Roche of the Development Costs actually incurred by it during such quarter (the “Actual Costs”), but for the first three quarters of each calendar year such reports shall be for informational purposes only and Roche’s payment of Development Costs shall continue to be made in accordance with the Budget for such year then in effect. At the end of each calendar year, the parties shall reconcile any difference between the amounts paid to Gilead for Development Costs and Gilead’s Actual Costs for such year. If the amounts paid to Gilead for Development Costs exceed its Actual Costs during such year, the amount of the excess shall be refunded or credited to Roche. If Gilead’s Actual Costs during the year exceeded the amounts paid by Roche for Development Costs during such year, the excess shall be paid by Roche as a supplemental payment if Roche approves such excess amount, which approval shall not be unreasonably withheld.

3.4 Adverse Reactions. Roche shall be responsible for reporting to the appropriate regulatory authorities all adverse events related to the use of Product worldwide, except that prior to the time Gilead transfers ownership of the IND to Roche as provided in Section 3.2(b), Gilead shall be responsible for the reporting of such adverse events in the U.S. Adverse events related to the use of Product worldwide shall be recorded in a single database, and the parties will coordinate their efforts to assure that all adverse events are reported properly.

 

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A RTICLE 4

D UE D ILIGENCE

4.1 Due Diligence. Roche shall devote its Best Efforts to commercialize Product in substantially all markets in the world. As used herein, “Best Efforts” shall mean that Roche is performing its obligations in a sustained manner consistent with the efforts major pharmaceutical companies devote to significant general practice products of similar market potential derived from internal research programs. Upon gaining the necessary regulatory, pricing and reimbursement approvals, Roche and/or its sublicensees shall use its Best Efforts to promote and market the Product in all significant markets. Any sublicense of marketing rights by Roche shall include a covenant for such sublicensee to use Best Efforts to maintain and increase sales of the Product in each country covered by the sublicense.

4.2 Global Commercial Roll-Out. Roche shall endeavor to obtain prompt approval for the sale of Product in substantially all countries of the world, once such approval has been obtained in the United States and Europe. In particular, subject to the exception set forth below, Gilead shall have the right to terminate Roche’s license to any particular Product in any country of the world [ * ] where such approval has not been obtained within [ * ] following the date on which such Product was first approved in all of the following countries: [ * ] (For such purpose, “approval” shall mean approval as to safety and efficacy but not pricing approval if separately required.) Gilead shall not have the right to terminate Roche’s license in any particular country where Roche can show that either (a) it used Best Efforts to achieve such registration within the specified time period, or (b) it is not reasonable to commercialize the Product in the country in question (for example, because of pricing). If Roche believes that either of the conditions set forth in the previous sentence apply, it shall so notify the Steering Committee at least one year prior to the expiration of the [ * ] time period referred to above, and shall explain its reasons. If Roche loses Product rights in any country pursuant to this Section 4.2, Gilead shall obtain rights thereto as provided in Section 9.5. [ * ] Roche shall not be subject to the time limit set forth in this Section 4.2, but shall still be obligated to use its Best Efforts to obtain approval as promptly as is reasonably practicable.

4.3 Commercial Due Diligence. If, regardless of whether Roche exercises Best Efforts, annual Net Sales of Products worldwide are less than [ * ] by the conclusion of the [ * ] following the date of First Commercial Sale of a Product in the U.S. or any country of the EU, then the parties agree to meet and confer in good faith regarding the most appropriate corrective actions to take in significant markets. The following factors shall be considered by the parties in determining the most appropriate course of action: (i) Roche’s competitive position, including promotional spending levels, sizes of field

 

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sales forces and market development expenditures, relative to competitive products; (ii) cost of goods sold; (iii) policy of health authorities on prophylaxis of influenza and (iv) Gilead’s interest in, and ability to increase revenues by, assuming all rights to the Product. In the event the parties agree that the rights to the Product shall revert to Gilead, the parties shall thereupon agree on appropriate commercial terms for the reversion of such rights.

4.4 Reports. Roche shall provide annual reports to Gilead as follows: (i) by February 1 of each year concerning its marketing activities relating to Products for the previous year, and (ii) by November 30 of each year concerning its contemplated marketing activities relating to Products for the subsequent year. In particular, such reports shall include specific budgets and timetables for activities in the [ * ] , the positioning of the Product, competitive issues, and Roche’s primary sales and marketing objectives with respect to Products in such countries.

 

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A RTICLE 5

C OMPENSATION

5.1 License Fee. Roche shall pay to Gilead a license fee of five million dollars ($5,000,000) within ten (10) days following the Effective Date. Such license fee shall be nonrefundable and noncreditable.

5.2 Milestone Payments. Roche shall pay to Gilead the following nonrefundable, noncreditable amounts within thirty (30) days of achievement of the milestone events set forth below for any Product 1 :

 

     U.S.     EU    Japan

Safety and bioavailability demonstrated in Phase I Clinical Trial

   $ 3,000,000 2     None      None

Commencement of first Phase III Clinical Trial

   $ 3,000,000 3     None    $ 2,000,000

NDA or equivalent filing 4

   $ 5,000,000     $ 5,000,000    $ 2,000,000

NDA or equivalent approval 4

   $ 8,000,000     $ 8,000,000    $ 4,000,000

1 Each of the milestone payments provided for in this Section 5.2 shall be payable no more than once and shall encompass all Products taken together.
2 Payable regardless of the territory in which such trial is conducted. This milestone shall be satisfied in any event by a decision to proceed to a Phase II clinical trial in influenza-infected patients.
3 Payable for any such trial that would qualify as a Phase III Clinical Trial for a U.S. NDA, even if such trial is conducted outside the U.S.
4 If an NDA filing seeks, or approval provides for, product labeling only as to Therapy or Prophylaxis, but not both, the payments associated with such milestone(s) shall be (i) 60% of the listed amounts if the NDA filing or approval is directed only to Therapy and (ii) 40% of the listed amounts if the NDA filing or approval is directed only to Prophylaxis. If only one indication is filed for or approved initially, the balance of the payments shall be paid upon achieving the relevant milestones for the other indication at a later date. Therapy is defined herein as the treatment of patients suffering from the symptoms of influenza. Prophylaxis is defined herein as either preventative treatment of individuals presumed to be infected by the influenza virus or the treatment of asymptomatic patients who may or may not be infected by the influenza virus.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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5.3 Royalty Payments; Adjustments.

(a) Royalty on Products . Roche shall pay Gilead a royalty payment on Net Sales of Product sold by Roche, its Affiliates or licensees (the “Royalty”) according to the following rates, as adjusted in accordance with subsections (c), (d), (e) and (f) below:

(i) Fourteen percent (14%) of worldwide Net Sales for the first $200 million in Net Sales in a given calendar year;

(ii) Eighteen percent (18%) of worldwide Net Sales for the next $200 million in Net Sales during the same calendar year; and

(iii) Twenty-two percent (22%) of worldwide Net Sales for Net Sales in excess of $400 million during the same calendar year.

By way of example, if, in the year 2005, Roche’s total Net Sales equal $450 million, then the Royalty payable to Gilead hereunder shall equal $75 million, calculated in the following manner:

 

Amount of Net Sales

   Royalty Rate    Royalty Payment

First $200 Million

   0.14    $ 28.0 Million

Next $200 Million

   0.18      36.0 Million

Next $50 Million

   0.22      11.0 Million
         

Total Royalty

      $ 75.0 Million

(b) Royalty Payment Schedule . For the first calendar year of Net Sales, the Royalty shall be paid to Gilead in accordance with the schedule set forth in subsection (a) above. Beginning in the second calendar year of Net Sales, Roche’s first three (3) quarterly payments shall be based upon the average royalty rate payable with respect to the previous calendar year. Following the fourth (4th) quarter of each calendar year, Roche shall pay Gilead the Royalty owing for the full year minus the aggregate payments made for the first three quarters or, if the aggregate payments made for the first three quarters exceed the Royalty owing for the full year, Gilead shall refund the difference to Roche.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(c) Unlicensed Competition Adjustment. Except as provided below, if a Third Party not under license from Roche sells a Generically Equivalent Product in a country or countries in which Roche, an Affiliate or sublicensee is selling Product and the monetary value of such Third Party’s sales of Generically Equivalent Product, as determined by a reliable Third Party and measured in a manner as near as practicable to the sales of Product in the same country, are equal to or greater than fifteen percent (15%) of the monetary value of the Adjusted Gross Sales of Product in such country or countries, then the royalty payable by Roche to Gilead on Net Sales of Product in such country(ies) shall be reduced by fifty percent (50%) of the Royalty set forth in subsection (a), until such time as the Third Party’s sales drop below fifteen percent (15%) of the Adjusted Gross Sales in such country(ies). The royalty reduction provided for in this paragraph (c) shall be inapplicable during any period of time that Gilead is diligently pursuing litigation to enforce Gilead Patent Rights or Joint Patent Rights to stop the sale of the Generically Equivalent Product in question in such country.

(d) Cost of Goods Sold Adjustment. Except as provided below, if the Cost of Goods Sold for a Product exceeds ten percent (10%) of the Net Sales of such Product in any particular calendar quarter, each measured on a worldwide basis, then the Royalty payable for such quarter shall be reduced by one-half of the amount by which such Cost of Goods Sold exceeds ten percent (10%) of Net Sales. Any Royalty reductions effected under this paragraph (d) shall be known as a “COGS Adjustment Amount”, and shall become payable to Gilead in the future in any time period(s) in which the Cost of Goods Sold for the Product in question is less than ten percent (10%) of the Net Sales of such Product, each measured on a worldwide basis. In such time periods, Gilead shall recover one-half of the amount by which the Cost of Goods Sold is less than ten percent (10%) of Net Sales, until it has fully recovered the COGS Adjustment Amount, without interest. This paragraph (d) shall not effect any reduction in the Royalty rate to less than fifty percent (50%) of the rate set forth in paragraph (a), and shall be inapplicable with respect to Product sales as to which adjustment is separately provided for under paragraph (c) or (e).

(e) Secondary Patent Coverage. The Royalty rates set forth in paragraph (a) above are based on the assumption that one or more Valid Claims of the Gilead Patent Rights, Roche Patent Rights or Joint Patent Rights, if any, applicable to the Product in question will Cover the composition of matter of the neuraminidase inhibitor which is an active ingredient in the Product. If, however, one or more Gilead Patent Rights, Roche Patent Rights or Joint Patent Rights Cover the manufacture, use or sale of such Product, but there is no Valid Claim Covering the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient in the Product, then the following Royalty rates shall apply. In the event a sale of a particular Product in a particular country might be described in more than one of the following subparagraphs, the highest royalty rate shall apply to such sale.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(i) In any event, regardless of patent Coverage, each Product shall be royalty-bearing at the rate set forth in paragraph (a), subject to adjustment as provided elsewhere under this Agreement but not under this paragraph (e), for the first [ * ] following First Commercial Sale in each country. If following such [ * ] period there is no patent Coverage for the manufacture, use or sale of the Product in a particular country, sales of such Product shall thereafter be royalty-free in that country. If, however, after such [ * ] period there is patent Coverage for the manufacture, use or sale of the Product, but not the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient of the Product, then the royalties set forth in Sections 5.3(e)(ii)-(v) shall apply.

(ii) If the manufacture, use or sale of the Product (but not the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient of the Product) is Covered by a Gilead Patent Right, then the royalty rates set forth in paragraph (a) shall be reduced by [ * ] Such reduced rate shall remain subject to further reduction pursuant to paragraph (c), in which case the royalty rate could be reduced to [ * ] of the rate set forth in paragraph (a), but there shall not be any reduction pursuant to paragraph (d) or by reason of Third Party license fees as described in Section 10.4.

(iii) If the manufacture, use, or sale of the Product (but not the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient of the Product) is Covered By a Joint Patent Right, then the royalty rates set forth in paragraph (a) shall be reduced to [ * ] of such rate. Such reduced rate shall remain subject to further reduction pursuant to paragraph (c) but only to a royalty rate which is [ * ] of the rate set forth in paragraph (a), and there shall not be any reduction pursuant to paragraph (d) or by reason of Third Party license fees as described in Section 10.4.

(iv) If the manufacture, use or sale of the Product (but not the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient of the Product) is Covered by a Roche Patent Right based on an invention made or obtained in connection with Roche’s work related to Products, then the royalty rate set forth in paragraph (a) shall be reduced to [ * ] of such rate. Such reduced rate shall not be subject to any further reduction under this Agreement.

(v) If the manufacture, use or sale of the Product (but not the composition of matter of the influenza neuraminidase inhibitor which is an active ingredient of the Product) is Covered only by a Valid Claim of a Roche patent based on

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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an invention by Roche, which invention was made independently of Roche’s work related to Products resulting from the Development Plan, then no royalty shall be due under this Agreement.

(f) Summary of Rules Regarding Royalty Adjustments. In implementing the various Royalty adjustment provisions of this Agreement:

(i) Royalty reductions under paragraphs (c) and (e) shall be determined on a country by country basis. If a Royalty adjustment is called for in one or more countries, but not worldwide, then the Royalty shall be calculated initially as set forth in paragraph (a), and the Royalty reduction shall be applied on the basis of the average worldwide Royalty rate otherwise payable.

(ii) If an adjustment is made under paragraph (c) (Unlicensed Competition Adjustment), then there shall not be any adjustment under paragraph (d) (Cost of Goods Sold Adjustment) with respect to the same sale of Product.

(iii) If an adjustment is made under paragraph (e) (Secondary Patent Coverage), then such reduced rate shall still be subject to further reduction as provided in paragraph (c) (Unlicensed Competition Adjustment), in which case the Royalty could be reduced to [ * ] of the rate set forth in paragraph (a), but there shall not be any reduction under paragraph (d) (Cost of Goods Sold Adjustment) or by reason of Third Party license fees as described in Section 10.4.

(iv) Except as expressly provided in Sections 5.3(e)(ii)-(v), the Royalty rate shall not be reduced to less than [ * ] of the rate set forth in Section 5.3(a).

(g) Expiration of Royalty Obligations. The royalty obligations set forth in subsection (a) above shall expire on a country-by-country basis upon the later of: (i) in those countries in which a Gilead Patent Right, Joint Patent Right or Roche Patent Right covers the manufacture, use or sale of a Product sold by Roche, its Affiliate or a licensee, the date upon which the manufacture, use or sale of such Product would no longer infringe a Valid Claim of a Gilead Patent Right, Joint Patent Right or Roche Patent Right in the absence of rights thereunder; and (ii)  [ * ] after the date of First Commercial Sale of the Licensed Product in such country(ies).

5.4 Sublicense. In the event Roche sublicenses its right to sell a Product, such sublicenses shall include an obligation for the sublicensee to account for and report its Net Sales of such Product on the same basis as if such sales were Net Sales of Product by Roche, and Roche shall pay the applicable Royalty to Gilead as if the Net Sales of the sublicensee were Net Sales of Roche.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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5.5 Payment Structure. The effect of this Article 5 is to provide for a royalty payment to Gilead for any Product discovered, developed or acquired by either party prior to the fifth anniversary of the Effective Date of this Agreement, whether or not such Product is Covered by a patent and irrespective of which party owns or controls any relevant patents. In establishing this payment structure, the parties seek to create incentives for a highly effective collaboration relating to Products with minimum potential for disputes, including by way of example possible disagreements related to the allocation of work and the determination of inventorship; to recognize that discoveries and developments related to influenza neuraminidase inhibitors after the Effective Date are likely to constitute improvements on existing Gilead Know-How, whether or not such new developments are within the scope of Gilead Patents; and to provide incentive compensation to Gilead for its anticipated work during the term of this Agreement, in addition to the grant of a patent license, to enable the rapid and effective market introduction of Products worldwide. Roche acknowledges that Gilead has offered, and Roche has voluntarily declined, a royalty arrangement under which Roche would pay independent royalties on Gilead Know-How and Gilead Patent Rights, and that instead of such independent royalties Roche has negotiated the royalty adjustment provisions of this Section 5.3.

A RTICLE 6

M ANUFACTURING

6.1 Pre-Commercial Manufacturing. It is the intention of the parties that initial pre-clinical and clinical Products, including the bulk drug substance contained therein, will be produced by Gilead, and that so long as it shall do so the cost of such manufacturing will be included in Development Costs. The parties also understand that as part of the Development Plan and the Budget they will cooperate to improve the manufacturing process in existence as of the Effective Date. Roche may assume full control of clinical manufacturing of Products at its own expense at any time it desires upon written notice to Gilead, and shall in any event have the sole and exclusive responsibility for the manufacture of clinical Products not later than the commencement of Phase III Clinical Trials for the initial Product.

6.2 Commercial Manufacturing. Roche shall be solely and exclusively responsible at its own expense for commercial manufacture of Products, either itself or through Third Parties.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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A RTICLE 7

M ARKETING

7.1 Pricing. Roche shall determine, in its sole discretion, the pricing, discounting policy and other commercial terms relating to Products.

7.2 Use of The Gilead Name. Gilead and Roche agree that the packaging and promotional materials for the Product marketed by Roche and/or Roche’s sublicensees shall identify Gilead as licensor. Roche hereby acknowledges Gilead’s ownership of the Gilead Sciences name. Gilead hereby agrees to indemnify and hold Roche harmless from any use hereunder of the Gilead Sciences name which occurs with the consent of Gilead, provided that Roche provides Gilead prompt notice of any such claim and grants to Gilead the exclusive ability to defend (with the reasonable cooperation of Roche) and settle any such claim. If only one name is allowed to be in any specific item of packaging or promotional material pursuant to governmental laws or regulations, then Roche may use its name alone on such item, without identifying Gilead as licensor.

A RTICLE 8

P AYMENTS ; R ECORDS ; A UDIT

8.1 Payment; Report. All amounts payable to either party under this Agreement shall be paid in U.S. dollars within [ * ] of the end of each calendar quarter or as otherwise specifically provided herein. Each payment of royalties owing to Gilead shall be accompanied by a statement, on a country-by-country basis, of the amount of gross sales, an itemized calculation of Adjusted Gross Sales and Net Sales showing deductions provided for in Section 1.15 during such quarter, the amount of aggregate worldwide gross sales, Adjusted Gross Sales and Net Sales during such quarter and on a cumulative basis for the current year and the amount of Royalty or other payments due on such sales. If any Royalty reductions are claimed by Roche under this Agreement from the full rates set forth in Section 5.3(a), then the report shall set forth in detail the claimed reduction and the related facts.

8.2 Exchange Rate; Manner and Place of Payment. All payments due hereunder from time to time shall be paid in U.S. Dollars. For purposes of computing such payments, the Net Sales of Product in countries other than the United States shall be converted into U.S. Dollars as computed in the central Roche currency conversion system, using the average monthly rate of exchange at the time for such currencies as retrieved from the Reuters System used by Roche. If convenient for Roche, such conversion may be made initially into Swiss Francs and then into U.S. Dollars for

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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purposes of calculating the Royalty, provided that Gilead is not disadvantaged by reason of such multiple conversions (e.g., that the conversion rates used by Roche do not reflect transaction costs of conversion). The currency conversion system used by Roche shall be subject to audit by Gilead as described in Section 8.3 and, if not determined to be a system reflecting the fair market value of the currencies in question, shall be modified as necessary to effect currency conversion at fair market value.

Notwithstanding the foregoing, if by reason of any restrictive exchange laws or regulations, Roche shall be unable to convert to U.S. Dollars the amount, determined as above, equivalent to the amount due by Roche hereunder, then Roche shall so notify Gilead promptly and provide an explanation of the circumstances. In such event, Roche shall make all such payments or the balance thereof due hereunder and which is not paid in foreign currency as provided below, in U.S. Dollars as soon as reasonably possible after and to the extent that such restrictive exchange laws or regulations are lifted so as to permit Roche to pay amounts due under this Section 8.2 in U.S. Dollars. Roche shall promptly notify Gilead if such restrictions are so lifted. At its option Gilead shall meanwhile have the right to request the payment (to it or to its nominee), and, upon request, Roche shall pay or cause to be paid amounts due (or such portions thereof as are specified by Gilead) in the currency of any other country designated by Gilead and legally available to Roche under the then-existing laws of regulations. Any payments shall be payable to Gilead by wire transfer at such bank in the United States as Gilead shall specify from time to time. Not less than one (1) business day prior to such wire transfer, the remitting party shall telefax the receiving party advising it of the amount and of the payment to be made.

8.3 Records and Audit. Roche shall keep, and shall cause its Affiliates and sublicensees to keep, complete and accurate records pertaining to the sale or other disposition of Product and of the Royalty and other amounts payable under this Agreement in sufficient detail to permit Gilead to confirm the accuracy of all payments due hereunder. At Gilead’s request, Roche will cause its independent certified public accountants to prepare abstracts of Roche’s relevant business records for review by Gilead’s independent certified public accountants. If, based on a review of such abstracts, Gilead reasonably believes that a full audit of said business records would be necessary for the confirmation of the accuracy of all payments due hereunder, Gilead’s independent certified public accountants shall have full access to review all work papers and supporting documents pertinent to such abstracts, and shall have the right to discuss such documentation with Roche’s independent certified public accountants. [ * ] Such audit rights may be exercised no more often than once a year, within three (3) years after the payment period to which such records relate, upon notice to Roche and during normal business hours. Gilead will bear the full cost of such audit unless such audit discloses an underpayment of more than five percent (5%) from the amount of royalties due. Roche shall promptly make up any underpayment. The terms of this Section 8.3 shall survive any termination or expiration of this Agreement for a period of three (3) years.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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8.4 Withholding Taxes. Any and all taxes levied on account of royalty payments paid or owed from a country in which provision is made in the law or by regulation for withholding will be deducted from royalty payments made to Gilead hereunder. Roche shall cooperate with Gilead to claim exemption from such deductions or withholdings under any double taxation or similar agreement in force from time to time. In addition, Roche shall cooperate with Gilead in all proper respects to minimize any taxes on royalties hereunder. If Roche makes any payment without reduction for withholding and it later transpires that an amount of tax should have been withheld on such royalty payment (“underwithheld tax”), Roche shall be entitled to recover the underwithheld tax by an additional withholding from any payment due to Gilead under this Agreement. Similarly, if Roche withholds an amount of tax which is later determined to have not been due, Roche shall reimburse Gilead for such over withheld amounts. Gilead shall have the right to audit correspondence and records relating to such tax issues on the same terms as described in Section 8.3 above.

A RTICLE 9

T ERM AND T ERMINATION

9.1 Term. The term of this Agreement shall commence upon the Effective Date and, unless sooner terminated as provided in this Article 9, expire on the expiration of royalty obligations set forth herein.

9.2 Licenses upon Expiration. In the event that the Agreement expires as set forth in Section 9.1 above without early termination, the license granted under Section 2.1 with respect to the Gilead Patents and Gilead Know-How shall automatically become a non-exclusive, irrevocable, fully-paid license to use and/or sublicense the use of Gilead Know-How to manufacture, use and sell Products in each country where such license had previously been in effect. In the event one or more countries are eliminated from the scope of the Roche license pursuant to Section 4.2 or 9.6, the license to Roche in this Section 9.2 shall not apply to such countries.

9.3 Termination for Breach. Each party shall have the right to terminate this Agreement and its obligations hereunder for material breach by the other party, which breach remains uncured for ninety (90) days after written notice is provided to the breaching party, or in the case of an obligation to pay a Royalty or other payments owing under this Agreement, which breach remains uncured for thirty (30) days after written notice to the breaching party unless there exists a bona fide dispute as to whether such Royalty or other payments are owing. Notwithstanding any termination under this Section 9.3, any obligation to pay Royalty or other payments which had accrued or become payable as of the date of termination shall survive termination of this Agreement.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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9.4 Termination for Gilead’s Breach. In the event Roche terminates this Agreement pursuant to Section 9.3 above, all licenses granted to Roche under this Agreement shall survive, subject to Roche’s continued obligation to pay Royalties to Gilead hereunder. Roche shall retain all of its rights to bring an action against Gilead under Article 14, including all of its rights for recovery of damages.

9.5 Product Reversion. In the event Gilead terminates this Agreement pursuant to Section 9.3 above, or Roche terminates this Agreement pursuant to Section 9.6, all licenses granted to Roche under Section 2.1 hereof shall terminate, all rights to Products shall automatically revert to Gilead, and Roche shall cooperate with Gilead in all respects to effect the prompt and efficient transfer to Gilead of Product development and marketing activities. In the event of such termination, Roche hereby assigns to Gilead all right, title and interest in and to all regulatory filings and approvals pertaining to Products. In addition, contingent upon such termination, Roche hereby grants to Gilead an exclusive, royalty-free license under the Roche Patents and the Roche Know-How which are necessary or useful for the manufacture, use or sale of the Product(s) as such product(s) exist as of the date of termination. Gilead’s rights to practice such Roche technology shall be limited exclusively to the purpose of development and commercialization of products that would be Products hereunder. If Roche terminates its rights in one or more countries under Section 9.6, or loses its rights in one or more countries pursuant to Section 4.2, this Section 9.5 shall apply only in the countries in which such termination is effective. If such termination occurs on less than a worldwide basis, Roche shall (i) supply the requirements of Gilead or its subsequent licensee for Product (in bulk or finished form), or intermediates of such Product, at Roche’s Cost of Goods Sold, so long as Roche manufactures or procures the Product or intermediate for its own account, and (ii) at Gilead’s request, assist reasonably in the transfer of manufacturing processes to new suppliers. If such termination occurs on a worldwide basis, then Roche shall (i) provide such supply, to the extent it had established it for its own account prior to such termination, and (ii) at Gilead’s request, assist reasonably in the transfer of manufacturing processes to new suppliers. Gilead agrees that in the event this Section 9.5 comes into effect, it will use diligent efforts to effect the transfer of Product manufacturing activities to Third Parties as soon as practicable. Roche’s supply obligation under this Section 9.5 shall in any event not continue for more than two (2) years after such termination.

9.6 Termination by Roche For Convenience. Roche shall also have the right in its discretion to terminate this Agreement on a worldwide basis or on a country by country basis, on twelve (12) months advance written notice, provided that (i) Roche shall

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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remain responsible for its performance of this Agreement during the 12-month period following the giving of such notice, (ii) Roche shall remain responsible for the completion of any clinical trials of Product which commenced prior to the giving of such notice, even if such trial continued beyond such twelve (12)-month period, and (iii) on a worldwide or country by country basis, as the case may be, Roche shall grant the licenses and effect the transfers provided for in Section 9.5. In such event, if Gilead grants a license to a Third Party to the Product rights surrendered by Roche prior to the end of such twelve (12)-month period, Gilead shall use diligent efforts to cause such new licensee to assume its pro rata share of the costs for which Roche is responsible under this Section 9.6 in respect of the Product rights being obtained by the new licensee (where “ pro rata ” refers to the period of time remaining in the twelve (12)-month notice period at the time Gilead enters into such new agreement).

9.7 Survival. Articles 1, 5, 9, 10, 11, 12, 14 and 15 and Sections 3.3(b) and 8.3 of this Agreement shall survive termination of this Agreement for any reason (subject to any subsequent dates of termination referred to in such individual Articles).

A RTICLE 10

I NTELLECTUAL P ROPERTY

10.1 Ownership of Inventions. Each party shall own any inventions made solely by its employees or agents. Inventions made jointly by employees or agents of each party shall be owned jointly by the parties (“Joint Inventions”). Inventorship shall be determined in accordance with U.S. patent laws.

10.2 Prosecution of Patents.

(a) Gilead Patents. Gilead Patents shall be prosecuted (including the handling of interferences) and maintained by Gilead or its licensors. Gilead shall furnish Roche with copies of draft submissions to the relevant patent authorities and will consider Roche’s comments. If Roche does not provide Gilead with comments within thirty (30) days of receipt of a draft, Gilead shall be free to proceed with its submission or other contemplated action. Further, Gilead shall always be entitled to proceed with any submission or other contemplated action if it determines time is of the essence, provided that Gilead makes reasonable efforts to inform Roche as early as practicable and to consider its comments where possible. In the event that Gilead elects not to maintain any issued patent within the Gilead Patents or not to file any patent term extensions to the Gilead Patents which Roche believes are appropriate to obtain an extended period of market exclusivity for Product, Roche shall have the right to elect to have Gilead or its licensors maintain such patents or file for such patent term extensions at Roche’s sole expense. Gilead shall bear the costs incurred in connection with the

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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prosecution and maintenance of Gilead Patents, except that Roche shall make a one-time nonaccountable and noncreditable payment to Gilead in the amount of [ * ] within ten (10) days of the Effective Date as an additional license fee in consideration of Gilead’s obligation to prosecute and maintain the Gilead Patents after the Effective Date.

(b) Roche Patents Covering Products. It is anticipated that as part of this collaborative development program, patents may be filed by and issued to Roche that may cover compositions of matter (including formulations) of Products as well as biological uses or processes for the manufacture of Products. These patents shall be prosecuted (including the handling of interferences) and maintained by Roche, at its expense. Roche shall furnish Gilead with copies of draft submissions to the relevant patent authorities and will consider Gilead’s comments. If Gilead does not provide Roche with comments within thirty (30) days of receipt of a draft, Roche shall be free to proceed with its submission or other contemplated action. Further, Roche shall always be entitled to proceed with any submission or other contemplated action if it determines time is of the essence, provided that Roche makes reasonable efforts to inform Gilead as early as practicable and to consider its comments where possible. Roche shall not abandon claims Covering Products without prior notice to and consultation with Gilead, and shall not abandon patent applications covering Products without first offering assignment of such applications to Gilead, which if it accepts such assignment shall thereafter prosecute such applications at its sole expense and in its sole discretion. In the event such applications are assigned to Gilead, Roche shall retain a nonexclusive license. Such license shall be royalty free outside of the field of neuraminidase inhibitors, and shall be subject to the Royalties set forth in Section 5.3 within the field of neuraminidase inhibitors.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(c) Joint Patents. With respect to Joint Inventions, the parties shall meet and agree upon which party shall prosecute patent applications Covering such Joint Invention. If either party prosecutes a patent application on a Joint Invention, such party shall bear its own internal costs, and the external costs for outside counsel, filing fees, etc. shall be borne equally by the parties, except as provided in the final sentence of this paragraph. Except for the licenses granted herein, each party shall be entitled to practice and sublicense Joint Inventions without restriction or an obligation to account to the other party. Either party may disclaim its interest in any particular patent or patent application covering a Joint Invention, in which case (i) the disclaiming party shall assign its ownership interest in such patent or patent application to the other party without consideration, (ii) the party which is then the sole owner shall be solely responsible for all future costs of such patent or patent application, and (iii) the disclaiming party shall hold no further rights thereunder, except for a nonexclusive license. Such license shall be royalty free outside of the field of neuraminidase inhibitors, and shall be subject to the Royalties set forth in Section 5.3 within the field of neuraminidase inhibitors.

10.3 Infringement of Patents by Third Parties.

(a) Notification. Each party shall promptly notify the other in writing of any alleged or threatened infringement of the Gilead Patent Rights, Joint Patent Rights or Roche Patent Rights of which it becomes aware.

(b) Gilead Patent Rights. Gilead shall have the right, but not the obligation, to bring, at Gilead’s expense and in its sole control, an appropriate action against any person or entity infringing a Gilead Patent Right directly or contributorily. If Gilead does not bring such action within ninety (90) days (forty five (45) days in the case of an action brought under the Hatch-Waxman Act) of notification thereof to or by Roche, Roche shall have the right, but not the obligation, to bring at Roche’s expense and in its sole control, such appropriate action. The party not bringing an action under this paragraph (b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such party shall cooperate fully with the party bringing such action.

(c) Roche Patent Rights. With respect to Roche Patent Rights, Roche may take such action as it deems in its best interests. Gilead shall not have any right to bring an action under Roche Patent Rights, but shall have the right to be fully informed regarding any litigation brought thereunder by Roche, including the status of any settlement activity.

(d) Joint Patent Rights. With respect to Third Party infringement of Joint Patent Rights, the parties shall confer and take such action, and allocate expenses and recoveries in such manner, as they may agree. In the absence of agreement, the rules applicable to Gilead Patent Rights shall apply to the Joint Patent Rights in question.

 

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(e) Costs and Awards. The party which is not in control of any action brought pursuant to Section 10.3(b), (c) or (d) may elect to contribute fifty percent (50%) of the costs of litigation against such Third Party infringer, by providing written notice to the controlling party within ninety (90) days after such action is first brought. If the non-controlling party elects to bear fifty percent (50%) of such litigation costs, it shall receive fifty percent (50%) of any damage award or settlement resulting from such action. If the non-controlling party does not elect to share such litigation costs, it shall not participate in any damage award or settlement resulting from such action.

(f) Settlement; Allocation of Proceeds. Neither party shall settle a claim brought under this Section 10.3 without the consent of the other party. In the event of any recovery of monetary damages from the Third Party, whether such damages result from the infringement of Gilead Patents or Roche Patents, such recovery shall be allocated first to the reimbursement of any expenses incurred by the parties in the litigation under this Section 10.3 (including, for the purpose, a reasonable allocation of internal counsel and other expenses), and thereafter as provided in Section 10.3 (e). If the amount recovered from the Third Party is less than the aggregate expenses of the parties incurred in connection with such litigation, the recovery shall be shared pro rata between Gilead and Roche in proportion to their respective expenses.

10.4 Infringement of Third Party Rights. In the event that any Product manufactured, used or sold under this Agreement becomes the subject of a Third Party claim or there is the potential for a claim for patent infringement anywhere in the world, and irrespective of whether Gilead or Roche is charged with said infringement, the parties shall promptly meet to consider the claim and the appropriate course of action. Unless the parties otherwise agree, the party against which such Third Party infringement claim is brought shall defend against such claim at its sole expense and the other party shall have the right, but not the obligation, to participate in any such suit, at its sole option and at its own expense. Such other party shall reasonably cooperate with the party conducting the defense of the claim, including if required to conduct such defense, furnishing a power of attorney. Neither party shall enter into any settlement that affects the other party’s rights or interests without such other party’s written consent, which consent shall not be unreasonably withheld. If in the opinion of Roche’s counsel, a license with respect to such Third Party patents is necessary to avoid substantial risks which could prevent Roche from making, using, selling, offering for sale or importing Product, then Roche shall notify Gilead of such conclusion and the basis for it and give Gilead a reasonable opportunity to discuss Roche’s opinion. If Gilead concurs in Roche’s opinion, Roche shall have the right to negotiate directly with such Third Party for a license, and Roche

 

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shall be entitled to apply [ * ] of Third Party Royalties for Net Sales in the country where the claim exists, as a credit against royalties due under Section 5.3; provided, however, that the aggregate credit taken in any given calendar quarter shall not exceed [ * ] of the royalties payable to Gilead during that quarter, on a country-by-country basis, and shall be subject to further limitations as expressly set forth in Section 5.3. If Gilead does not concur with Roche’s opinion, the matter shall be submitted to an independent counsel, selected by mutual consent and paid equally by Roche and Gilead, to determine whether there is a substantial risk of infringement of such Third Party rights. If such independent counsel determines that a substantial risk exists, then Roche may negotiate directly with such Third Party and receive royalty credit as set forth above. If such independent counsel determines that a substantial risk does not exist, then Roche may still negotiate for a license from such Third Party if it elects to do so, but Roche shall not have the right of royalty reduction provided for in this Section 10.4.

10.5 Patent Marking. Products marketed and sold by Roche hereunder shall be marked with appropriate patent numbers or indicia at Gilead’s request, subject to Roche’s consent, not to be unreasonably withheld.

A RTICLE 11

I NDEMNIFICATION

11.1 Indemnification by Gilead. Gilead hereby agrees to indemnify, hold harmless and defend Roche against any and all expenses, costs of defense (including without limitation attorneys’ fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims (i) arise out of the breach or alleged breach of any representation or warranty by Gilead hereunder, or (ii) are due to the negligence or misconduct of Gilead; provided that (a) Roche provides Gilead with prompt notice of any such claim and the exclusive ability to defend (with the reasonable cooperation of Roche) and settle any such claim and (b) such indemnities shall not apply to the extent such claims are covered by Roche’s indemnity set forth in Section 11.2 below.

11.2 Indemnification by Roche. Roche hereby agrees to indemnify, hold harmless and defend Gilead against any and all expenses, costs of defense (including without limitation attorneys’ fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Gilead becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims (i) result from Roche’s activities under this Agreement, (ii) arise out of the breach or alleged breach of any representation or warranty by Roche hereunder, (iii) are due to the negligence or misconduct of Roche, or (iv) arise out of the possession, manufacture, use, sale or

 

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administration of the Product by Roche or Roche’s Affiliates or sublicensees; provided that (a) Gilead provides Roche with prompt notice of any such claim and the exclusive ability to defend (with the reasonable cooperation of Gilead) or settle any such claim and (b) such indemnities shall not apply to the extent such claims are covered by Gilead’s indemnity set forth in Section 11.1 above.

11.3 Mechanics. In the event that the parties cannot agree as to the application of Sections 11.1 and 11.2 above to any particular loss or claim, the parties may conduct separate defenses of such claim. Each party further reserves the right to claim indemnity from the other in accordance with Sections 11.1 and 11.2 above upon resolution of the underlying claim, notwithstanding the provisions of Sections 11.1 and 11.2 above requiring the indemnified party to tender to the indemnifying party the exclusive ability to defend such claim or suit.

11.4 Insurance Coverage. Each party represents and warrants that it is covered and will continue to be covered by a comprehensive general liability insurance program which covers all of each Party’s activities and obligations hereunder. Each party shall provide the other party with written notice at least fifteen (15) days prior to any cancellation or material change in such insurance program. Each party shall maintain such insurance program, or other program with comparable coverage, beyond the expiration or termination of this Agreement during (i) the period that any Product is being commercially distributed or sold other than for the purpose of obtaining regulatory approvals by Roche or by a sublicensee, Affiliate or agent of Roche and (ii) a commercially reasonable period thereafter.

 

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A RTICLE 12

C ONFIDENTIALITY

12.1 Proprietary Information; Exceptions. Each party will maintain all Proprietary Information received by it under this Agreement in trust and confidence and will not disclose any such Proprietary Information to any Third Party or use any such Proprietary Information for any purposes other than those necessary or permitted for performance under this Agreement. In particular, Roche shall not use any Gilead Know-How for any purpose other than those expressly licensed under Section 2.1. Each party may use the other’s Proprietary Information only to the extent required to accomplish the purposes of this Agreement. Proprietary Information shall not be used for any purpose or in any manner that would constitute a violation of any laws or regulations, including without limitation the export control laws of the United States. Proprietary Information shall not be reproduced in any form except as required to accomplish the intent of this Agreement. No Proprietary Information shall be disclosed to any employee, agent, consultant, Affiliate, or sublicensee who does not have a need for such information. To the extent that disclosure is authorized by this Agreement, the disclosing party will obtain prior agreement from its employees, agents, consultants, Affiliates, sublicensees or clinical investigators to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those permitted by this Agreement. Each party will use at least the same standard of care as it uses to protect its own Proprietary Information of a similar nature to ensure that such employees, agents, consultants and clinical investigators do not disclose or make any unauthorized use of such Proprietary Information, but no less than reasonable care. Each party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Proprietary Information.

Proprietary Information shall not include any information which:

(a) is now, or hereafter becomes, through no act or failure to act on the part of the receiving party in breach hereof, generally known or available;

(b) is known by the receiving party at the time of receiving such information, as evidenced by its written records;

(c) is hereafter furnished to the receiving party by a third party, as a matter of right and without restriction on disclosure;

 

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(d) is independently developed by the receiving party without any breach of this Agreement; or

(e) is the subject of a written permission to disclose provided by the disclosing party.

12.2 Authorized Disclosure. The parties shall issue a joint press release upon signing this Agreement. The parties agree that the material financial terms of the Agreement, other than the initial payments provided in Sections 3.3(c) and 5.1 and the aggregate milestone payments provided for in Section 5.2, will be considered Proprietary Information of both parties. Notwithstanding the foregoing, either party may make disclosures required by law or regulation, provided prior notice is given to the other party whenever possible, and may disclose the material financial terms of the Agreement to bona fide potential corporate partners, to the extent required or contemplated by this Agreement, and to financial underwriters, prospective investors and other parties with a need to know such information. Any such disclosures, and any disclosure of the development and marketing or Products or other developments under this Agreement, including but not limited to press releases, will be reviewed and consented to by each party prior to such disclosure. Such consent shall not be untimely or unreasonably withheld by either party. All such disclosures shall be made only to parties under an obligation of confidentiality.

Notwithstanding any other provision of this Agreement, each party may disclose Proprietary Information if such disclosure:

(a) is in response to a valid order of a court or other governmental body of the United States or a foreign country, or any political subdivision thereof; provided, however, that the responding party shall first have given notice to the other party hereto and shall have made a reasonable effort to obtain a protective order requiring that the Proprietary Information so disclosed be used only for the purposes for which the order was issued;

(b) is otherwise required by law or regulation, including SEC related documents; or

(c) is otherwise necessary to file or prosecute patent applications, prosecute or defend litigation or comply with applicable governmental regulations or otherwise establish rights or enforce obligations under this Agreement, but only to the extent that any such disclosure is necessary.

12.3 Return of Proprietary Information. In the event Roche loses its license to Gilead Patents and Gilead Know-How which was granted to it under this Agreement,

 

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Roche shall use diligent efforts (including without limitation a diligent search of files and computer storage devices) to return all Proprietary Information received by it from Gilead, provided, however, that Roche may keep one copy of such Proprietary Information for legal archival purposes. Access to the copy so retained by Roche’s legal department shall be restricted to counsel and such Proprietary Information shall not be used except in the resolution of any claims or disputes arising out of this Agreement.

12.4 Publications. Except as required by law, neither Party shall publish or present, or cause to be published or presented, the results of studies carried out with respect to Products without the opportunity for prior review by the other party. Each party shall provide to the other the opportunity to review any proposed abstracts, manuscripts or presentations which relate to Products at least thirty (30) days prior to their intended submission for publication and such submitting party agrees, upon written request from the other party, not to submit such abstract or manuscript for publication or to make such presentation until the other party is given a reasonable period of time to seek patent protection for any material in such publication or presentation that it believes is patentable.

A RTICLE 13

R EPRESENTATIONS AND W ARRANTIES

13.1 Mutual Representations and Warranties. Each party hereby represents and warrants:

(a) Corporate Power. Such party is duly organized and validly existing under the laws of the state of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

(b) Due Authorization. Such party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder.

(c) Binding Agreement. This Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it.

 

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13.2 Gilead Representations and Warranties. Gilead warrants and represents that:

(a) Safety Data. To the best of its knowledge, Gilead has informed Roche about all significant information in its possession or control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof with respect to any Product tests conducted by Gilead or its contractors. Roche acknowledges that such tests have been entirely preclinical and may not be indicative of results that may be obtained in humans.

(b) Patent Matters. As of the Effective Date, Gilead has no knowledge of the existence of any patent owned or controlled by a Third Party which covers the lead compound identified by Gilead to Roche (GS 4104) and would prevent Roche from making, using or selling such compound. To the best of Gilead’s knowledge and belief, as of the Effective Date, the patent applications listed in Exhibit A at the Effective Date are owned by Gilead and Gilead is not in possession of information that would, in its opinion, render invalid and/or unenforceable claims directed specifically to GS 4104 that are presently in one or more of such applications. Notwithstanding the foregoing, if at any time prior to December 31, 1997, a patent or patent application held by a Third Party is identified which covers the specific Product being developed by the parties pursuant to this Agreement, the parties will meet and discuss possible resolutions of the patent situation. If the resolution involves a license from the Third Party to its patent rights and/or a license to the Third Party under Gilead or Roche patent rights, the parties acknowledge that the economic assumptions underlying this Agreement may no longer be valid, and in such case the parties will renegotiate the terms of this Agreement in good faith in order to reflect such resolution.

13.3 No Other Representations. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS ARTICLE 13 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

A RTICLE 14

D ISPUTE R ESOLUTIONS ; V ENUE AND G OVERNING L AW

14.1 Disputes. The parties recognize that disputes as to certain matters may from time to time arise during the term of this Agreement which relate to either party’s rights and/or obligations hereunder or thereunder. It is the objective of the parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the parties agree to follow the procedures set forth in this Article 14 if and when a dispute arises under this Agreement.

 

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In the event of disputes between the parties, including disputes among the members of the Steering Committee which such committee is unable to resolve, a party seeking to resolve such dispute will, by written notice to the other, have such dispute referred to their respective executive officers designated below or their successors, for attempted resolution by good faith negotiations within fourteen (14) days after such notice is received. Said designated officers are as follows:

 

For Roche:    Head of the Pharma Division
For Gilead:    Chief Executive Officer

In the event the designated executive officers are not able to resolve such dispute, either party may at any time after the 14 day period invoke the provisions of Section 14.2 hereinafter.

14.2 Alternative Dispute Resolution. Following settlement efforts pursuant to Section 14.1, any dispute, controversy or claim arising out of or relating to the validity, construction, enforceability or performance of this Agreement, including disputes relating to alleged breach or to termination of this Agreement under Section 9.3, other than disputes which are expressly prohibited herein from being resolved by this mechanism, shall be settled by binding Alternative Dispute Resolution (“ADR”) in the manner described below:

(a) ADR Request. If a party intends to begin an ADR to resolve a dispute, such party shall provide written notice (the “ADR Request”) to counsel for the other party informing such other party of such intention and the issues to be resolved. From the date of the ADR Request and until such time as any matter has been finally settled by ADR, the running of the time periods contained in Section 9.3 as to which party must cure a breach of this Agreement shall be suspended as to the subject matter of the dispute.

(b) Additional Issues. Within ten (10) business days after the receipt of the ADR Request, the other party may, by written notice to the counsel for the party initiating ADR, add additional issues to be resolved.

(c) No ADR of Patent Issues. Disputes regarding the scope, validity and enforceability of patents shall not be subject to this Section 14.2, and shall be submitted to a court of competent jurisdiction.

 

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14.3 Arbitration Procedure. The ADR shall be conducted pursuant to the ENDISPUTE Rules then in effect, except that notwithstanding those rules, the following provisions shall apply to the ADR hereunder:

(a) Arbitrator. The arbitration shall be conducted by a panel of three arbitrators (the “Panel”). The Panel shall be selected from a pool of retired independent federal judges to be presented to the parties by ENDISPUTE.

(b) Proceedings. The time periods set forth in the ENDISPUTE rules shall be followed, unless a party can demonstrate to the Panel that the complexity of the issues or other reasons warrant the extension of one or more of the time tables. In such case, the Panel may extend such time tables, but in no event shall the time tables being extended so that the ADR proceeding extends more than 18 months from its beginning to the Award. In regard to such time tables, the parties (i) acknowledge that the issues that may arise in any dispute involving this Agreement may involve a number of complex matters and (ii) confirm their intention that each party will have the opportunity to conduct complete discovery with respect to all material issues involved in a dispute within the framework provided above. Within such time frames, each party shall have the right to conduct discovery in accordance with the Federal Rules of Civil Procedure. The Panel shall not award punitive damages to either party and the parties shall be deemed to have waived any right to such damages. The Panel shall, in rendering its decision, apply the substantive law of the State of California, without regard to its conflict of laws provisions, except that the interpretation of and enforcement of this Section 14.3(b) shall be governed by the Federal Arbitration Act. The Panel shall apply the Federal Rules of Evidence to the hearing. The proceeding shall take place in the City of New York. The fees of the Panels and ENDISPUTE shall be paid by the losing Party which shall be designated by the Panel. If the Panel is unable to designate a losing party, it shall so state and the fees shall be split equally between the parties.

(c) Award. The Panel is empowered to award any remedy allowed by law, including money damages, multiple damages, prejudgment interest and attorneys’ fee, and to grant final, complete, interim, or interlocutory relief, including injunctive relief but excluding punitive damages.

(d) Costs. Except as set forth in Section 14.3(b), above, each party shall bear its own legal fees. The Panel shall assess its costs, fees and expenses against the party losing the ADR unless it believes that neither party is the clear loser, in which case the Panel shall divide such fees, costs and expenses according to the Panel’s sole discretion.

(e) Confidentiality. The ADR proceeding shall be confidential and the Panel shall issue appropriate protective orders to safeguard each party’s

 

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Proprietary Information. Except as required by law, no party shall make (or instruct the Panel to make) any public announcement with respect to the proceedings or decision of the Panel without prior written consent of each other party. The existence of any dispute submitted to ADR, and the award, shall be kept in confidence by the parties and the Panel, except as required in connection with the enforcement of such award or as otherwise required by applicable law.

14.4 Judicial Enforcement. The parties agree that judgment on any arbitral award issued pursuant to this Article 14 shall be entered in the United States District Court for the Northern District of California or, in the event such court does not have subject matter jurisdiction over the dispute in question, such judgment shall be entered in the Superior Court of the State of California, in the County of San Mateo.

14.5 Governing Law. This Agreement is made in accordance with and shall be governed and construed under the laws of the State of California, as such laws are applied to contract entered into and to be performed within such state.

A RTICLE 15

M ISCELLANEOUS

15.1 Agency. Neither party is, nor will be deemed to be, an employee, agent or legal representative of the other party for any purpose. Neither party will be entitled to enter into any contracts in the name of, or on behalf of the other party, nor will a party be entitled to pledge the credit of the other party in any way or hold itself out as having authority to do so. This Agreement is an arm’s-length license agreement between the parties and shall not constitute or be construed as a joint venture.

15.2 Assignment. Except as otherwise provided herein, neither this Agreement nor any interest hereunder will be assignable in part or in whole by any party without the prior written consent of the other; provided, however, that either party may assign this Agreement to any of its Affiliates or to any successor by merger or sale of all or substantially all of its business assets to which this Agreement relates in a manner such that the assignor will remain liable and responsible for the performance and observance of all its duties and obligations hereunder. This Agreement will be binding upon the successors and permitted assigns of the parties and the name of a party herein will be deemed to include the names of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment which is not in accordance with this Section 15.2 will be void.

15.3 Amendment. No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed by both parties.

 

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15.4 Notices. Any notice or other communication required or permitted to be given to either party hereto shall be in writing unless otherwise specified and shall be deemed to have been properly given and to be effective on the date of delivery if delivered in person or by facsimile or three (3) days after mailing by registered or certified mail, postage paid, to the other party at the following address:

In the case of Gilead:

Gilead Sciences, Inc.

353 Lakeside Drive

Foster City, CA 94404

Telephone: (415) 574-3000

FAX: (415) 578-9264

Attention: Chief Executive Officer

and

Gilead Sciences, Inc.

353 Lakeside Drive

Foster City, CA 94404

Telephone: (415) 574-3000

Fax: (415) 572-6622

Attention: General Counsel

In the case of Roche:

F. Hoffmann-La Roche Ltd

CH-4070 Basel, Switzerland

Telephone: 41-61-688 30 60

FAX: 41-61-688 13 96

Attention: Corporate Law Department

and

Hoffmann-La Roche Inc.

340 Kingsland Street

Nutley, NJ 07110

Telephone: (201) 235-2165

FAX: (201) 235-3500

Attention: Corporate Secretary

 

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Either party may change its address for communications by a notice to the other party in accordance with this Section 15.4.

15.5 Force Majeure. Any prevention, delay or interruption of performance by any party under this Agreement shall not be considered a breach of this Agreement if and to the extent caused by occurrences beyond the reasonable control of the party affected, including but not limited to acts of God, embargoes, governmental restrictions, strikes or other concerted acts of workers, fire, flood, earthquake, explosion, riots, wars, civil disorder, rebellion or sabotage. The party suffering such occurrence shall immediately notify the other party and any time for performance hereunder shall be extended by the actual time of prevention, delay, or interruption caused by the occurrence.

15.6 Affiliates. The parties hereto acknowledge that Roche will carry out many of the activities required or permitted pursuant to this Agreement through its Affiliates. Roche hereby represents and warrants to Gilead that this Agreement shall be binding on its Affiliates and further guarantees the performance of its Affiliates in accordance with this Agreement as if such Affiliates were parties to this Agreement. In the event either party to this Agreement is acquired by another company, then the technology and programs of the acquiring company in existence at the time of such transaction shall not be subject to this Agreement.

15.7 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America or other countries which may be imposed upon or related to Gilead or Roche from time to time. Each party agrees that it will comply with all applicable export laws and regulations in connection with its activities under this Agreement.

15.8 Severability. If any term, condition or provision of this Agreement is held to be unenforceable for any reason, it shall, if possible, be interpreted, to achieve the intent of the parties to this Agreement to the extent possible rather than voided. If not capable of such interpretation, the parties shall in good faith seek to agree on an alternative provision reflecting the intent of the parties which is enforceable. In any event, all other terms, conditions and provision of this Agreement shall be deemed valid and enforceable to the full extent.

15.9 Cumulative Rights. The rights, powers and remedies hereunder shall be in addition to, and not in limitation of, all rights, powers and remedies provided at law or in equity, or under any other agreement between the parties. All of such rights, powers and remedies shall be cumulative, and may be exercised successively or cumulatively.

 

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15.10 Waiver. No waiver by either party hereto on any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent or similar breach or default.

15.11 Entire Agreement. This Agreement, and all Exhibits and Schedules referred to herein, embody the entire understanding of the parties with respect to the subject matter hereof and shall supersede all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof.

I N W ITNESS W HEREOF , the parties hereto have executed this Agreement by their respective officer hereunto duly authorized.

 

GILEAD SCIENCES, INC.     F. HOFFMANN-LA ROCHE LTD
By:  

/s/ John C. Martin

    By:  

/s/ W. Henrich

Name:   John C. Martin     Name:   Werner Henrich
Title:   CEO     Title:   Director
      HOFFMANN-LA ROCHE INC.
      By:  

/s/ Stephen Sulovar

      Name:   Stephen Sulovar
      Title:   Sr. Vice President

 

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Case No.

  

Title

  

Country

  

Appl. No.

  

Filing Date

[ * ]

           

EXHIBIT A

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

40

Exhibit 10.6

AGREEMENT AND PLAN OF MERGER

BY AND AMONG

GILEAD SCIENCES, INC.,

GRYPHON ACQUISITION SUB, INC.,

CORUS PHARMA, INC.

AND

RODNEY A. FERGUSON, PH.D, AS CHAIRMAN OF AND ON BEHALF OF THE

STOCKHOLDER REPRESENTATIVE COMMITTEE

D ATED AS OF A PRIL  12, 2006


AGREEMENT AND PLAN OF MERGER

This Agreement and Plan of Merger (this “ Agreement ”) is made and entered into as of April 12, 2006, by and among G ILEAD S CIENCES , I NC . , a Delaware corporation (“ Acquiror ”), G RYPHON A CQUISITION S UB , I NC . , a Delaware corporation and wholly owned subsidiary of Acquiror (“ Merger Sub ”), C ORUS P HARMA , I NC . , a Delaware corporation (the “ Company ”) and R ODNEY A. F ERGUSON , P H .D. , as Chairman of and on behalf of the Stockholder Representative Committee (the “ Stockholder Representative Committee ”).

RECITALS

A. The Company, Acquiror and Merger Sub believe it advisable and in their respective best interests to effect a merger of the Company and Merger Sub pursuant to this Agreement (the “ Merger ”). Upon consummation of the Merger, Merger Sub will cease to exist, and the Company will become a wholly owned subsidiary of Acquiror.

B. The Board of Directors of the Company has approved this Agreement and the Merger unanimously in accordance with applicable Law. This Agreement and the Merger will be submitted to the Stockholders for adoption and approval in accordance with the Delaware General Corporation Law (the “ DGCL ”).

C. The Boards of Directors of Acquiror and Merger Sub have approved this Agreement and the Merger in accordance with applicable Law.

D. Contemporaneously with the execution and delivery of this Agreement: (i) Acquiror and the Company are entering into a Series C Preferred Stock Purchase Agreement (2006 Extension) (the “ Series C Preferred Stock Purchase Agreement ”), pursuant to which Acquiror is purchasing from the Company 21,551,724 shares of Series C Preferred Stock (the “ Acquiror-Held Series C Shares ”); (ii) in connection with the purchase of such shares, Acquiror and the Company are entering into this Agreement, and Acquiror, the Company and certain Stockholders are entering into (A) an amendment to the Registration Rights Agreement and (B) the Stockholders’ Agreement; (iii) Acquiror and the Company are entering into a 1040 Product Agreement with respect to the Company 1040 Product (the “ 1040 Product Agreement ”); (iv) the Stockholders identified on Annex I (the “ Key Stockholders ”) are entering into Key Stockholder Agreements in favor of Acquiror (the “ Key Stockholder Agreements ”); (v) A. Bruce Montgomery, M.D. and William Baker, Ph.D are entering into Noncompetition Agreements in favor of the Company and Acquiror (the “ Noncompetition Agreements ”), to be effective as of the Closing; (vi) the officers and directors of the Company, each of the Key Stockholders and certain additional Stockholders are entering into General Releases in favor of the Company and Acquiror (the “ General Releases ”), to be effective as of the Closing; (vii) certain employees of the Company are executing Countersigned Offer Letters, to be effective as of the Closing; and (viii) Acquiror, the Company, A. Bruce Montgomery, M.D. and William Baker, Ph.D are entering into a Joint Defense, Common Interest and Confidentiality Agreement (the “ Joint Defense Agreement ”).


E. Certain capitalized terms used in this Agreement are defined in Article X . Annex II includes an index of all defined terms used in this Agreement.

AGREEMENT

In consideration of the terms hereof, the parties to this Agreement (the “ Parties ”) agree as follows:

ARTICLE I

THE MERGER

 

1.1 The Merger

Upon the terms and subject to the conditions hereof, (a) at the Effective Time the separate existence of Merger Sub shall cease and Merger Sub shall be merged with and into the Company, and the Company shall be the surviving corporation in the Merger (the “ Surviving Corporation ”), and (b) from and after the Effective Time, the Merger shall have all the effects of a merger under the DGCL and other applicable Law.

 

1.2 The Closing

Subject to Section 7.3 , and on the terms and subject to the conditions of this Agreement, the Closing shall take place on a date selected by Acquiror, which shall be no more than ten Business Days after the satisfaction or waiver of the last to be satisfied or waived of the conditions set forth in Articles IV and V (other than the conditions set forth in Sections 4.3 , 4.4 , 4.9 , 5.3 and 5.4 , which by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of each of such conditions), at the offices of Orrick, Herrington & Sutcliffe LLP, 719 Second Avenue, Suite 900, Seattle, Washington, or such other date, time or location as Acquiror and the Company shall agree (the date on which the Closing actually takes place being referred to in this Agreement as the “ Closing Date ”).

 

1.3 Effective Time

On the Closing Date and on the terms and subject to the conditions hereof, the Certificate of Merger shall be delivered for filing with the Secretary of State of the State of Delaware (the “ Delaware Secretary ”). The Merger shall become effective at the Effective Time. If the Delaware Secretary requires any changes in the Certificate of Merger as a condition to filing or issuing a certificate to the effect that the Merger is effective, Merger Sub and the Company shall execute any necessary revisions incorporating such changes, provided such changes are not inconsistent with and do not result in any material change in the terms of this Agreement.

 

1.4 Certificate of Incorporation of the Surviving Corporation

At the Effective Time, the Certificate of Incorporation of the Surviving Corporation shall be amended and restated to conform to the Certificate of Incorporation of Merger Sub as in effect immediately prior to the Effective Time, except that the name of the Surviving Corporation shall be “Corus Pharma, Inc.”

 

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1.5 Bylaws of the Surviving Corporation

At the Effective Time, the Bylaws of the Surviving Corporation shall be amended and restated to conform to the Bylaws of Merger Sub as in effect immediately prior to the Effective Time.

 

1.6 Directors and Officers

(a) At the Effective Time, the directors of the Company shall resign and the directors of the Surviving Corporation shall be those individuals designated by Acquiror in its sole discretion, who shall hold office in accordance with and subject to the Certificate of Incorporation and the Bylaws of the Surviving Corporation.

(b) At the Effective Time, the officers of the Company shall resign and the officers of the Surviving Corporation shall be those individuals designated by the board of directors of the Surviving Corporation in its sole discretion, who shall hold office in accordance with and subject to the Certificate of Incorporation and Bylaws of the Surviving Corporation, provided, however , that any such resignation of an officer of the Company pursuant to this Section 1.6(b) shall not be deemed for any purpose to be a voluntary termination of such officer’s employment with the Company.

 

1.7 Merger Consideration

1.7.1 Conversion of Shares

Subject to the other provisions of this Section 1.7 (including Sections 1.7.1(h) and 1.7.2) and Article VIII , at the Effective Time, by virtue of the Merger and without any action on the part of Acquiror, Merger Sub, the Company or any Stockholder:

(a) The following shares of Company Capital Stock shall be canceled and no consideration shall be delivered in respect thereof: (i) all shares of any class of Company Capital Stock held by the Company as treasury shares; and (ii) all Acquiror-Held Company Securities.

(b) Each share of Series A Preferred Stock outstanding immediately prior to the Effective Time shall be converted into the right to receive:

(i) an amount in cash equal to the sum of (x) the Series A Preference Amount plus (y) the product of (A) the Closing Distribution Percentage multiplied by (B) 1.8240647 multiplied by (C) the Residual Per Share Amount; and

(ii) an interest in any Holdback Payment made in accordance with Section 8.5 , payable to the holder thereof when such Holdback Payment is made hereunder, to the extent provided herein.

(c) Each share of Series B Preferred Stock outstanding immediately prior to the Effective Time shall be converted into the right to receive:

 

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(i) an amount in cash equal to the sum of (x) the Series B Preference Amount plus (y) the product of (A) the Closing Distribution Percentage multiplied by (B) the Residual Per Share Amount; and

(ii) an interest in any Holdback Payment made in accordance with Section 8.5 , payable to the holder thereof when such Holdback Payment is made hereunder, to the extent provided herein.

(d) Except as otherwise provided in Section 1.7.1(a) , each share of Series C Preferred Stock outstanding immediately prior to the Effective Time shall be converted into the right to receive:

(i) an amount in cash equal to the sum of (x) the Series C Preference Amount plus (y) the product of (A) the Closing Distribution Percentage multiplied by (B) the Residual Per Share Amount; and

(ii) an interest in any Holdback Payment made in accordance with Section 8.5 , payable to the holder thereof when such Holdback Payment is made hereunder, to the extent provided herein.

(e) Each share of Company Common Stock outstanding immediately prior to the Effective Time shall be converted into the right to receive:

(i) an amount in cash equal to the product of (x) the Closing Distribution Percentage multiplied by (y) the Residual Per Share Amount; and

(ii) an interest in any Holdback Payment made in accordance with Section 8.5 , payable to the holder thereof when such Holdback Payment is made hereunder, to the extent provided herein.

(f) Each Company Stock Option outstanding immediately prior to the Effective Time, whether vested or unvested, shall be assumed by Acquiror at the Effective Time. Each such Company Stock Option so assumed by Acquiror under this Agreement shall continue to have, and be subject to, the same terms and conditions set forth in the agreement evidencing such Company Stock Option and in the Company Option Plan, immediately prior to the Effective Time, including provisions with respect to restrictions on exercise, term, exercisability, vesting and acceleration, except that (i) each such assumed Company Stock Option will be exercisable for that number of whole shares of Acquiror Common Stock equal to the product (rounded down to the nearest whole share) of the number of shares of Company Common Stock that were issuable upon exercise of such Company Stock Option immediately prior to the Effective Time multiplied by the Option Exchange Ratio, and (ii) the per share exercise price under each such Company Stock Option shall be adjusted by dividing the per share exercise price of each such Company Stock Option by the Option Exchange Ratio, and rounding up to the nearest whole cent. The terms of each such assumed Company Stock Option shall, in accordance with its terms, be subject to further adjustment as appropriate to reflect any stock split, reverse stock split, stock dividend, recapitalization or other similar transaction with respect to Acquiror Common Stock

 

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subsequent to the Effective Time. Acquiror shall take all corporate action necessary to reserve for issuance a sufficient number of shares of Acquiror Common Stock for delivery upon the exercise of the Company Stock Options assumed by Acquiror. Acquiror will use commercially reasonable efforts to file, within 10 days following the Closing Date, a registration statement on Form S-8 (or any successor to Form S-8) so as to register the Acquiror Common Stock subject to the Company Stock Options assumed by Acquiror pursuant to this Section 1.7.1(f) , and shall use its reasonable efforts to effect such registration and to maintain the effectiveness of such registration statement (and the current status of the prospectus contained therein) for so long as such assumed Company Stock Options remain outstanding. At or before the Effective Time, the Company shall (1) take all actions that may be necessary or that Acquiror considers reasonably appropriate (under the Company Option Plan and otherwise) to effectuate the provisions of this Section 1.7.1(f) and to ensure that, from and after the Effective Time, holders of Company Stock Options have no rights with respect to such Company Stock Options other than those specifically provided in this Section 1.7.1(f) , and (2) cause to be effected, in a manner reasonably satisfactory to Acquiror, any amendments to the Company Option Plan necessary to give effect to the foregoing provisions of this Section 1.7.1(f) .

(g) The Company Warrant will not be assumed by Acquiror in the Merger. As a result, pursuant to the terms of the Company Warrant, the Company Warrant, to the extent not exercised prior to the Closing, shall be treated as set forth in Section 6.14 .

(h) By executing the applicable Letter of Transmittal and delivering their certificates representing shares of Company Capital Stock to the Paying Agent in accordance with the provisions of Section 1.7.3 , or by executing the Stockholder Consent personally or by proxy (or both), each Non-Dissenting Holder shall be deemed to have agreed to be bound with respect to the indemnification obligations and the procedures set forth in Article VIII .

(i) If any share of Company Common Stock outstanding immediately prior to the Effective Time is unvested or is subject to a repurchase option, risk of forfeiture or other condition under any applicable restricted stock purchase agreement or other Contract under which the Company has any rights, then the consideration otherwise payable with respect to such share of Company Common Stock pursuant to Section 1.7.1(e) will, except to the extent it vests by its terms as a result of this Agreement and the transactions contemplated hereby, also be unvested and subject to the same repurchase option, risk of forfeiture or other condition, and need not be paid or otherwise delivered to the former holder of such share of Company Common Stock until such time as such repurchase option, risk of forfeiture or other condition lapses or otherwise terminates. The Company shall, prior to the Effective Time, take all action that may be reasonably necessary to ensure that (and Acquiror shall have the right, from and after the Effective Time, to take all action that may be necessary to ensure that): (1) such consideration shall remain so unvested and subject to such repurchase option, risk of forfeiture or other condition; (2) such consideration need not be paid or otherwise delivered until such time as such repurchase option, risk of forfeiture or other condition lapses or otherwise terminates; and (3) Acquiror is entitled to exercise any such repurchase option or other right set forth in any such restricted stock purchase agreement or other Contract.

 

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(j) Each issued and outstanding share of capital stock of Merger Sub shall be converted into one share of common stock of the Surviving Corporation.

1.7.2 Dissenters’ Rights

(a) Notwithstanding any provision of this Agreement to the contrary, any issued and outstanding shares of Company Capital Stock held by a Dissenting Holder shall not be converted into or represent a right to receive consideration pursuant to Section 1.7.1(b) , Section 1.7.1(c) , Section 1.7.1(d) or Section 1.7.1(e) , as applicable, and such Dissenting Holder shall be entitled to only such rights with respect to its Dissenting Shares as are granted under Section 262 of the DGCL to a holder of Dissenting Shares.

(b) Notwithstanding the provisions of Section 1.7.2(a) , if any Dissenting Holder who demands appraisal of such Dissenting Holder’s Dissenting Shares under Section 262 of the DGCL shall effectively withdraw or lose his, her or its right to appraisal, then within 10 Business Days after the latest of (i) the Effective Time, (ii) the occurrence of such withdrawal or loss of such rights to appraisal and (iii) delivery of a duly executed Letter of Transmittal in the form attached hereto as Exhibit A and such other documents as may be reasonably required by Acquiror or the Paying Agent, and surrender by such holder of a certificate or certificates representing such Dissenting Shares, Acquiror shall deliver the consideration which such holder would have otherwise been entitled to receive in the Merger under Section 1.7.1(b)(i) , Section 1.7.1(c)(i) , Section 1.7.1(d)(i) or Section 1.7.1(e)(i) , as applicable, with respect to such Dissenting Shares, without interest thereon, and such Dissenting Holder shall thereafter be entitled to receive, as and when payable pursuant to this Agreement, the remaining consideration which such holder would have otherwise been entitled to receive in the Merger under Section 1.7.1(b) , Section 1.7.1(c) , Section 1.7.1(d) or Section 1.7.1(e) , as applicable, with respect to such Dissenting Shares, without interest thereon.

(c) The Company shall give Acquiror (A) prompt notice of any written demand for appraisal received by the Company prior to the Effective Time pursuant to the DGCL, any withdrawal of any such demand and any other demand, notice or instrument delivered to the Company prior to the Effective Time pursuant to the DGCL, and (B) the opportunity to participate in all negotiations and proceedings with respect to any such demand, notice or instrument. The Company shall not make any payment or settlement offer prior to the Effective Time with respect to any such demand, notice or instrument unless Acquiror shall have given its written consent to such payment or settlement offer.

1.7.3 Exchange of Stock Certificates

(a) The Company shall mail, or cause the Paying Agent to mail, promptly following the Closing Date, to (i) each holder of a certificate or certificates that immediately prior to the Effective Time represented outstanding shares of Company Capital Stock (“ Certificates ”), other than shares to be cancelled in accordance with Section 1.7.1(a) and Dissenting Shares, a duly executed Letter of Transmittal in the form attached hereto as Exhibit A and such other documents as may be reasonably required by Acquiror or the Paying Agent, and instructions for effecting the surrender of Certificates in exchange for the right to receive the

 

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consideration specified in Section 1.7.1(b) , Section 1.7.1(c) , Section 1.7.1(d) or Section 1.7.1(e) , as applicable. Upon delivery of a Letter of Transmittal to the Paying Agent, duly executed and a Certificate representing shares of Company Capital Stock, and such other documents as may reasonably be required by Acquiror or the Paying Agent, the holder of such Certificate shall be entitled, within 10 Business Days after receipt of the foregoing by the Paying Agent, to receive in exchange therefor a check or wire transfer representing the consideration that such Stockholder has the right to receive at Closing pursuant to Section 1.7.1(b)(i) , Section 1.7.1(c)(i) , Section 1.7.1(d)(i) or Section 1.7.1(e)(i) , as applicable, and the Certificate so surrendered shall forthwith be cancelled. Until surrendered as contemplated by this Section 1.7.3 , each Certificate shall be deemed, from and after the Effective Time, to represent only the right to receive upon such surrender the consideration specified in Section 1.7.1(b) , Section 1.7.1(c) , Section 1.7.1(d) or Section 1.7.1(e) , as applicable.

(b) In the event that any Certificate held by a Non-Dissenting Holder shall have been lost, stolen or destroyed, upon the making of an affidavit of that fact by such Non-Dissenting Holder claiming such Certificate to be lost, stolen or destroyed, and delivery by such Non-Dissenting Holder of such other documents as may be reasonably required by Acquiror or the Paying Agent, the Paying Agent shall deliver the consideration that such Non-Dissenting Holder is entitled to receive pursuant to Section 1.7.1(b)(i) , Section 1.7.1(c)(i) , Section 1.7.1(d)(i) or Section 1.7.1(e)(i) , as applicable, without interest; provided, however , that Acquiror may in its discretion and as a condition precedent to the delivery thereof, require such Stockholder to provide Acquiror with a bond and/or an indemnity agreement against any claim that may be made against Acquiror, the Surviving Corporation or the Paying Agent with respect to the Certificate alleged to have been lost, stolen or destroyed. If the consideration (or any portion thereof) is to be delivered to any Person other than the Person in whose name the Certificate representing shares of Company Capital Stock surrendered in exchange therefor is registered, it shall be a condition to such exchange that the Person requesting such exchange shall pay to Acquiror any transfer or other Taxes required by reason of the payment of such amount to a Person other than the registered holder of the Certificate so surrendered, or shall establish to the reasonable satisfaction of Acquiror that such Tax has been paid or is not applicable.

(c) Notwithstanding anything to the contrary in this Agreement, (a) Acquiror and the Surviving Corporation shall be entitled to deduct and withhold from any consideration payable to any holder or former holder of Company Capital Stock pursuant to this Agreement such amounts as Acquiror or the Surviving Corporation determines in good faith are required to be deducted or withheld therefrom under the Code or under any other Laws, and to the extent such amounts are so deducted or withheld, such amounts shall be treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid, and (b) neither Acquiror nor any other Party shall be liable to a holder of shares of Company Capital Stock for any cash amount delivered to a public official pursuant to applicable Law, including abandoned property, escheat and similar Laws.

1.7.4 No Further Transfers

After the Effective Time, there shall be no transfers of any shares of Company Capital Stock on the stock transfer books of the Surviving Corporation. If, after the Effective Time, any

 

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Certificates are presented to the Surviving Corporation together with the applicable Letter of Transmittal, they shall be forwarded to Acquiror and shall be canceled and exchanged in accordance with this Section 1.7 .

1.7.5 No Further Issuances of Securities of the Company

After the Secondary Period Commencement Date, except as otherwise expressly permitted by Section 6.2(c) , there shall be no further issuances of Company Capital Stock, Company Stock Options or Company Stock Rights; provided, however , that nothing in this Section 1.7.5 shall preclude a Stockholder from receiving Company Common Stock prior to the Closing upon proper exercise of a Company Stock Option, Company Warrant or other Company Stock Right duly authorized, issued and outstanding on the date of execution of this Agreement, or preclude Acquiror from receiving Company Capital Stock prior to the Closing upon proper exercise of any Company Stock Right held by Acquiror.

1.7.6 Automatic Adjustment to Provisions of Section 1.7

In the event that at the time the Aggregate Closing Transaction Value is determined, the Aggregate Closing Transaction Value is or could be insufficient to fully pay the aggregate preferences of the Company Preferred Stock, the Parties will make such changes to Section 1.7 (and any other related provisions of the Agreement) as may be necessary to reflect such insufficiency, consistent with the liquidation preferences and distribution priorities among classes and series of Company Capital Stock set forth in the Company Certificate of Incorporation in the event of a “Liquidation Event” (as defined therein), provided that no such changes shall have any adverse effect on Acquiror, the Holdback Amount or the rights of any of the Indemnified Parties hereunder.

 

1.8 Closing Payment Schedule

The Company shall deliver to Acquiror, on or prior to the Closing Date, an accurate and complete schedule (the “ Closing Payment Schedule ”) setting forth: (A) the name of each Person who is a Stockholder of the Company immediately prior to the Effective Time (after giving effect to any exercises of Company Stock Options or the Company Warrant); (B) the number of shares of Company Capital Stock of each class and series held by each such Stockholder immediately prior to the Effective Time (after giving effect to any exercises of Company Stock Options or the net exercise of the Company Warrant); (C) subject to Section 6.17 , the Pre-Merger Specified Litigation Loss Amount (accompanied by a detailed breakdown of the components thereof and reasonable backup for the amounts included in the calculation thereof); (D) the consideration that each such Stockholder is entitled to receive pursuant to Section 1.7.1(b)(i) , Section 1.7.1(c)(i) , Section 1.7.1(d)(i) or Section 1.7.1(e)(i) , as applicable; (E) the maximum amount of consideration that each such Stockholder may become entitled to receive pursuant to Section 1.7.1(b)(ii) , Section 1.7.1(c)(ii) , Section 1.7.1(d)(ii) or Section 1.7.1(e)(ii) , as applicable; and (F) the holder of, the exercise price per share of, the number of shares of Company Common Stock subject to, the vesting schedule (including the effect of any vesting as a result of the Merger or any of the other Contemplated Transactions, alone or together with any other event) applicable to and the expiration date of each Company Stock Option outstanding immediately prior to the Effective Time (after giving effect to any exercises of Company Stock Options prior to the Effective Time).

 

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1.9 Further Action

If, at any time after the Effective Time, any further action is determined by Acquiror to be necessary or desirable to carry out the purposes of this Agreement or to vest the Surviving Corporation or Acquiror with full right, title and possession of and to all rights and property of Merger Sub and the Company, the officers and directors of the Surviving Corporation and Acquiror shall be fully authorized (in the name of Merger Sub, in the name of the Company and otherwise) to take such action.

ARTICLE II

REPRESENTATIONS AND WARRANTIES OF THE COMPANY

Except as is otherwise set forth in the particular schedule to the Disclosure Memorandum corresponding to the particular Section or subsection in this Article II in which a representation and warranty of the Company appears (it being understood, however, that a disclosure in a particular schedule to the Disclosure Memorandum will also be deemed to qualify a representation and warranty that does not appear in the corresponding Section or subsection in this Article II if it is reasonably apparent on the face of such disclosure that such disclosure would also qualify such representation and warranty), the Company represents and warrants to Acquiror and Merger Sub as of the date of this Agreement, as of the Secondary Period Commencement Date and as of the Closing Date as follows in this Article II . For all purposes of this Article II (including for purposes of the defined terms used in this Article II) , each Predecessor Entity shall be deemed part of the “ Company ” and all references to the “ Company ” shall (unless the context otherwise requires) be deemed to include references to each of the Predecessor Entities.

 

2.1 Organization; Power and Authority

(a) The Company (i) is a corporation duly organized, validly existing and in good standing under the Laws of the State of Delaware, (ii) has all requisite corporate power and authority to own, operate and lease its properties and Assets and to carry on its business as currently conducted and as currently proposed to be conducted by the Company, and (iii) is duly qualified and licensed as a foreign corporation to do business and is in good standing (with respect to jurisdictions that recognize such concept) in each jurisdiction in which the character of its properties occupied, owned or held under lease or the nature of the business it conducts makes such qualification or licensing necessary, except where the failure to be so qualified and licensed or in good standing would not have a Company Material Adverse Effect.

(b) The Company has not conducted any business under or otherwise used, for any purpose or in any jurisdiction, any fictitious name, assumed name, trade name or other name, other than the name “Corus Pharma, Inc.” or the names of the Predecessor Entities.

 

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(c) Schedule 2.1(c) to the Disclosure Memorandum accurately sets forth, as of the date of this Agreement, (i) the names of the members of the board of directors of the Company; and (ii) the names and titles of the officers of the Company.

(d) The Company has Made Available to Acquiror accurate and complete copies of: (a) the Company Certificate of Incorporation, and the Company Bylaws, including all amendments thereto; (b) the stock records of the Company and the Predecessor Entities; and (c) the minutes and other records of the meetings and other proceedings (including any actions taken by written consent or otherwise without a meeting) of the stockholders of the Company and the Predecessor Entities, the boards of directors of the Company and the Predecessor Entities and all committees of the boards of directors of the Company and the Predecessor Entities. The books of account, stock records, minute books and other records of the Company are accurate, up-to-date and complete in all material respects.

(e) The mergers of the Predecessor Entities into the Company were effected in full conformity with all applicable Laws and did not (i) result in a default (with or without the giving of notice or lapse of time, or both) under, or acceleration or termination of, or the creation in any party of the right to accelerate, terminate, modify or cancel, any Material Contract; (ii) result in the creation of any Encumbrance upon any material Assets of the Company or any of the Predecessor Entities, or upon any outstanding shares or other securities of the Company; (iii) conflict with or result in a breach of or constitute a default under any provision of the Company Certificate of Incorporation or Company Bylaws or the organizational documents of any of the Predecessor Entities; or (iv) invalidate or adversely affect any Consent, permit, license or authorization material to the conduct of the business of the Company or any of the Predecessor Entities. The merger of each of Abaris, Salus and Summanus with and into the Company became effective on January 1, 2004.

 

2.2 Enforceability

The Company has full corporate power and authority to enter into and perform its obligations under this Agreement and the other Operative Documents to which it is or is to become a party, and to consummate the Contemplated Transactions. All corporate action on the part of the Company and its officers, directors and Stockholders necessary for the authorization, execution, delivery and performance of this Agreement and the other Operative Documents to which the Company is or is to become a party, the consummation of the Merger, and the performance of all of the Company’s obligations under this Agreement and the other Operative Documents to which the Company is or is to become a party has been taken or (with respect to the adoption by the Stockholders of the Merger Agreement and the approval by the Stockholders of the Merger, as provided under the DGCL and the Company Certificate of Incorporation and Company Bylaws) will be taken as of or prior to the Effective Time. The Board of Directors of the Company (at a meeting duly called and held) has unanimously (a) determined that the Merger is advisable and in the best interests of the Stockholders and is on terms that are fair to the Stockholders, (b) authorized and approved the execution, delivery and performance of this Agreement by the Company and approved the Merger and (c) recommended that the Stockholders execute the Stockholder Consent adopting this Agreement and approving the Merger. This Agreement has been, and each of the other Operative Documents to which the

 

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Company is or is to become a party has been or will have been, at the Closing, duly executed and delivered by the Company, and this Agreement is, and each of the other Operative Documents to which the Company is or is to become a party is or will be, at the Closing, a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as to the effect, if any, of the Enforceability Exceptions.

 

2.3 Capitalization

(a) The authorized capital stock of the Company consists of 150,000,000 shares of Company Common Stock and 128,030,982 shares of Company Preferred Stock, of which 8,468,757 shares are designated as Series A Preferred Stock, 41,113,949 shares are designated as Series B Preferred Stock and 78,448,276 shares are designated as Series C Preferred Stock.

(b) As of the date of this Agreement, the issued and outstanding Company Capital Stock consists of 10,019,401 shares of Company Common Stock and 127,173,051 shares of Company Preferred Stock (of which 8,468,757 shares are Series A Preferred Stock, 41,113,949 shares are Series B Preferred Stock and 77,590,359 shares are Series C Preferred Stock), which are held of record and beneficially by the Stockholders as set forth on Schedule 2.3(b) to the Disclosure Memorandum. Such outstanding shares are, and any additional shares of Company Capital Stock issued on or after the date of this Agreement and prior to the Effective Time will be, duly authorized and validly issued, fully paid and nonassessable, not subject to statutory or, to the knowledge of the Company, contractual preemptive rights or rights of first refusal, and issued in compliance with all applicable federal and state securities Laws. To the Company’s knowledge, no Person other than the Stockholders holds any interest in any of the outstanding shares of Company Capital Stock.

(c) As of the date of this Agreement, other than (i) Company Stock Options to purchase up to 10,662,241 shares of Company Common Stock that have been granted under the Company Option Plan, and (ii) the Company Warrant, which will be exercised or terminated prior to the Effective Time, there are no outstanding Company Stock Rights other than the rights of holders of Company Preferred Stock to convert such shares into shares of Company Common Stock. The Company has reserved 13,000,000 shares of Company Common Stock for issuance under the Company Option Plan. Schedule 2.3(c) to the Disclosure Memorandum sets forth a spreadsheet accurately and completely reflecting, as of the date of this Agreement, the Company Stock Options outstanding, the grant dates, vesting schedules and exercise prices thereof and, in each case, the names of the holders. The Company has Made Available to Acquiror accurate and complete copies of the Company Option Plan, the Company’s standard form of stock option agreement and all exercise documentation relating to Company Stock Options granted thereunder and all agreements relating to the Company Warrant and any other Company Stock Rights. No Company Stock Option has been granted pursuant to an agreement that deviates in any material respect from the standard form of stock option agreement attached as an exhibit to the Company Option Plan. None of the Company Option Plan or any such agreements and exercise documentation have been amended, modified or supplemented, and there are no agreements to amend, modify or supplement such Company Option Plan and agreements, in any case from the form Made Available to Acquiror. Schedule 2.3(c) to the Disclosure Memorandum also

 

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identifies all Company Stock Options or other Company Stock Rights that have been offered in connection with any employee or consulting agreement but that, as of the date of this Agreement, have not been issued or granted. No Company Stock Option is held by a Person residing or domiciled outside of the United States.

(d) Other than the Operative Documents, the Company is neither a party nor subject to any Contract, and, to the Company’s knowledge, there is no Contract between any Persons, that affects or relates to the voting or giving of written consents with respect to any securities of the Company or the voting by any director of the Company. No Stockholder, and no Affiliate of any Stockholder, is indebted to the Company, and the Company is not indebted to any Stockholder or any Affiliate thereof, other than for payment of employee salaries and expense reimbursements incurred in the ordinary course of business and consistent with past practice.

(e) All rights of first refusal, co-sale rights and registration rights granted by the Company with respect to the Company Capital Stock or Company Stock Rights are described on Schedule 2.3(e) to the Disclosure Memorandum.

(f) The Company does not have the right nor is the Company under any obligation, nor is the Company bound by any Contract pursuant to which it may have the right or become obligated, to repurchase, redeem or otherwise acquire any outstanding shares of Company Capital Stock or any other securities. Schedule 2.3(f) to the Disclosure Memorandum provides an accurate and complete description of the terms of each repurchase option which is held by the Company and to which any of the shares of Company Capital Stock is subject.

(g) Except as otherwise expressly contemplated by this Agreement, there is no: (i) outstanding subscription, option, call, warrant, right or other Company Stock Right (whether or not currently exercisable) to acquire any shares of the capital stock or other securities of the Company; (ii) outstanding security, instrument, obligation or other Company Stock Right that is or may become convertible into or exchangeable for any shares of the capital stock or other securities of the Company; or (iii) Contract under which the Company is or may become obligated to sell or otherwise issue any shares of its capital stock or any other securities.

(h) All outstanding shares of capital stock, options, warrants and other securities of the Company have been issued and granted in compliance in all material respects with (i) all applicable securities Laws and other applicable Laws, and (ii) all requirements set forth in applicable Contracts.

(i) The Company has never repurchased, redeemed or otherwise reacquired any shares of Company Capital Stock or other securities, other than Company Stock Options forfeited by Company Associates in connection with the termination of their employment with the Company. All securities so reacquired by the Company were reacquired in compliance with (i) all applicable Laws, and (ii) all requirements set forth in applicable restricted stock purchase agreements and other applicable Contracts.

 

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(j) The manner in which Company Stock Options are to be treated in connection with the Merger as provided in Section 1.7.1(f) is acknowledged, represented and warranted by the Company to be permissible under all applicable Laws, under the terms of the Company Option Plan and under the terms of all stock option agreements pursuant to which any Company Stock Options have been granted or are otherwise outstanding, and does not require the Consent of the holder of any Company Stock Option or any other Person.

(k) The manner in which the Company Warrant is to be treated in connection with the Merger as provided in Section 6.14 is permissible under all applicable Laws and under the terms of the Company Warrant, and does not require the Consent of the holder of the Company Warrant or any other Person.

(l) The Closing Payment Schedule, when delivered to Acquiror on behalf of the Company, will be accurate and complete.

 

2.4 Subsidiaries and Affiliates

The Company does not own or control, directly or indirectly, any other Entity. The Company, directly or indirectly, does not own any ownership, equity or voting interest in any other Entity, nor does it have any agreement or commitment to purchase any such interest. There are no other Entities that the Company is required or permitted to consolidate for financial reporting purposes under GAAP. The Company has not agreed nor is the Company obligated to make, nor is the Company bound by any Contract under which it may become obligated to make, any investment in or capital contribution to any other Entity. There are no other Entities that have been merged into or that otherwise are predecessors to the Company, other than Abaris, Salus and Summanus.

 

2.5 No Approvals; No Conflicts

The execution, delivery and performance by the Company of this Agreement and the other Operative Documents to which the Company is or is to become a party, the execution, delivery and performance by each of the Key Stockholders of its Key Stockholder Agreement and the other Operative Documents to which such Key Stockholder is or is to become a party, the consummation by the Company of the Contemplated Transactions, the effectiveness of the Merger and the performance by the Company of its obligations pursuant to this Agreement and the other Operative Documents to which it is or is to become a party, did not, do not and will not (individually or in combination): (a) constitute a violation (with or without the giving of notice or lapse of time, or both) of any provision of Law or any Order applicable to the Company; (b) require any Consent of, or declaration, filing or registration with, any Person, except for (i) the filing of all documents necessary to consummate the Merger with the Delaware Secretary; (ii) the adoption by the Stockholders of this Agreement and the approval by the Stockholders of the Merger, as provided under the DGCL and the Company Certificate of Incorporation and Company Bylaws; and (iii) any required submissions under the HSR Act that the Company or Acquiror reasonably determines should be made, in each case, with respect to the Merger and the other Contemplated Transactions; (c) result in a default (with or without the giving of notice or lapse of time, or both) under, or acceleration or termination of, or the creation in any Person of

 

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the right to accelerate, terminate, modify or cancel, any Material Contract; (d) result in the creation of any Encumbrance upon any material Assets of the Company, or upon any outstanding shares or other securities of the Company; (e) conflict with or result in a breach of or constitute a default under any provision of the Company Certificate of Incorporation or Company Bylaws; or (f) invalidate or adversely affect any Governmental Authorization material to the business of the Company as currently conducted or as currently proposed to be conducted by the Company.

 

2.6 Financial Statements

(a) The Company has Made Available to Acquiror (a) audited balance sheets, statements of operations, statements of cash flows and statements of convertible preferred stock and stockholders’ deficit of the Company as of and for each of the fiscal years ended December 31, 2002, 2003 and 2004 (including related footnotes and the opinion of Ernst & Young with respect thereto) and (b) an unaudited balance sheet, statement of operations, statement of cash flows and statement of stockholders’ deficit of the Company as of and for the interim period ended on the Balance Sheet Date (collectively, the financial statements described in clauses “(a)” and “(b)” being referred to in this Agreement as the “ Company Financial Statements ”). The Company Financial Statements have been prepared (and the financial statements referred to in Section 6.5(c) will be prepared) in conformity with GAAP on a basis consistent with prior accounting periods (except for normal, recurring period-end adjustments that could not be reasonably expected to be material and except that the Company Financial Statements that are unaudited do not include all required footnotes), are (and in the case of the financial statements referred to in Section 6.5(c) will be) accurate and complete in all material respects and fairly present (and in the case of the financial statements referred to in Section 6.5(c) will fairly present) the financial position, results of operations and changes in financial position of the Company as of the dates and for the periods indicated. The Company has no Liabilities that are not fully reflected or reserved against in the Company Balance Sheet, except Liabilities under the Operative Documents and Liabilities incurred since the Balance Sheet Date in the ordinary course of business and consistent with past practice that are not in excess of $250,000 in the aggregate or $100,000 individually. The Company maintains standard systems of accounting that are adequate for its business. The Company is not a guarantor, indemnitor, surety or other obligor of any indebtedness of any other Person.

(b) There are no (and there have not at any time been any) securitization transactions or “off-balance sheet arrangements” (as defined in Item 303(c) of Regulation S-K of the SEC) effected or maintained in effect by the Company.

(c) The Company maintains books and records reflecting its Assets and Liabilities that are accurate and complete and maintains adequate internal accounting controls so that: (i) transactions are entered into only with management’s authorization; (ii) transactions are recorded as necessary to permit preparation of the financial statements of the Company and to maintain accountability for the Assets and Liabilities of the Company; (iii) access to the Assets of the Company is permitted only in accordance with management’s authorization; (iv) the reporting of the Assets and Liabilities of the Company is compared with existing Assets and Liabilities at regular intervals; and (v) all Assets, Liabilities, rights, obligations and transactions are recorded accurately.

 

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2.7 Absence of Certain Changes or Events

Except for transactions specifically contemplated in this Agreement or as expressly set forth in Schedule 2.7 to the Disclosure Memorandum, since the Balance Sheet Date, (1) there has not been any Company Material Adverse Effect, and no event has occurred or circumstance has arisen that, in combination with any other events or circumstances, could reasonably be expected to have or result in a Company Material Adverse Effect, (2) there has not been any material loss, damage or destruction to, or any material interruption in the use of, any of the material Assets of the Company (whether or not covered by insurance), and (3) neither the Company nor any of its Representatives (on behalf of the Company) has:

(a) taken any action or entered into or agreed to enter into any transaction, agreement or commitment other than in the ordinary course of business and consistent with past practice;

(b) forgiven or canceled any indebtedness or waived any claims or rights of material value (including any indebtedness owing by any Stockholder, officer, director, employee or Affiliate of the Company);

(c) granted any increase in the compensation of directors, officers, employees or consultants (including any such increase pursuant to any employment agreement or bonus, pension, profit-sharing, lease payment or other plan or commitment) or any increase in the compensation payable or to become payable to any director, officer, employee or consultant, except in such case as granted to non-officer employees in the ordinary course of business and consistent with past practice;

(d) suffered any change having a Company Material Adverse Effect;

(e) borrowed or agreed to borrow any funds, or, incurred or become subject to, whether directly or by way of assumption or guarantee or otherwise, any indebtedness for borrowed money in excess of $100,000 individually or in excess of $250,000 in the aggregate, except Liabilities that are incurred in the ordinary course of business and consistent with past practice, or increased, or experienced any change in any assumptions underlying or methods of calculating, any bad debt, contingency or other reserves;

(f) paid, discharged or satisfied any material claims or Liabilities other than the payment, discharge or satisfaction in the ordinary course of business and consistent with past practice of claims and Liabilities reflected or reserved against in the Company Balance Sheet or incurred in the ordinary course of business and consistent with past practice or in connection with the transactions contemplated by this Agreement or in connection with the Specified Litigation since the Balance Sheet Date, or prepaid any obligation having a fixed maturity of more than 90 days from the date such obligation was issued or incurred;

(g) knowingly permitted or allowed any of its property or Assets to be subjected to any Encumbrance, except in the ordinary course of business and consistent with past practice;

 

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(h) purchased or sold, transferred or otherwise disposed of any of its material properties or Assets other than in the ordinary course of business and consistent with past practice;

(i) disposed of or permitted to lapse any rights to the use of any material trademark, trade name, patent or copyright, or disposed of or disclosed to any Person without obtaining a commercially reasonable confidentiality agreement from any such Person any material trade secret, formula, process or know-how not theretofore a matter of public knowledge;

(j) made any single capital expenditure or commitment in excess of $100,000 for additions to property, plant, equipment or intangible capital Assets or made aggregate capital expenditures in excess of $250,000 for additions to property, plant, equipment or intangible capital Assets;

(k) made any change in accounting methods or practices or internal control procedure or become aware of any material misstatements or significant deficiencies or material weaknesses in internal control;

(l) issued any capital stock or other securities or Company Stock Rights, or declared, paid or set aside for payment any dividend or other distribution in respect of its capital stock, or redeemed, purchased or otherwise acquired, directly or indirectly, any shares of capital stock or other securities of the Company or Company Stock Rights, or otherwise permitted the withdrawal by any of the holders of Company Capital Stock of any cash or other Assets, in compensation or reimbursement of expenses, indebtedness or otherwise, other than pursuant to the exercise of Company Stock Options and payments of compensation or reimbursement of expenses in the ordinary course of business and consistent with past practice;

(m) paid, loaned or advanced any amount to, or sold, transferred or leased any properties or Assets to, any of the Stockholders or any Affiliate of any of the Stockholders or the officers, directors or employees of the Company, except compensation paid to directors, officers and employees in the ordinary course of business consistent with past practice and except for advances and reimbursements for travel and other business-related expenses incurred in the ordinary course of business consistent with past practice; or

(n) agreed or committed, whether in writing or otherwise, to take any action described in this Section 2.7 .

 

2.8 Taxes

(a) The Company has timely filed and will timely file with the appropriate Governmental Entities all Tax Returns that are required to be filed by it prior to the Closing Date. All such Tax Returns were correct and complete in all material respects and, in the case of Tax Returns to be filed, will be correct and complete in all material respects. All Taxes shown on such Tax Returns have been timely paid and, in the case of Tax Returns to be filed, will be timely paid. The Company currently is not the beneficiary of any extension of time within which to file

 

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any Tax Return. No claim has ever been made in writing by an authority in a jurisdiction where the Company does not file Tax Returns that the Company is or may be subject to taxation in that jurisdiction. There are no security interests or other liens on any of the Assets of the Company that arose in connection with any failure (or alleged failure) to pay any Tax, other than liens for Taxes not yet due and payable.

(b) The Company has timely withheld and paid to the appropriate Governmental Entity all material Taxes required to have been withheld and paid in connection with amounts paid or owing to any employee, independent contractor, creditor, stockholder or other third party.

(c) There is no dispute concerning any Tax Liability of the Company raised by any Governmental Entity in writing to the Company that remains unpaid, and the Company has not received written notice of any threatened audits or investigations relating to any Taxes.

(d) The Company has not waived any statute of limitations in respect of Taxes or agreed to, or requested, any extension of time with respect to a Tax assessment or deficiency.

(e) The unpaid Taxes of the Company did not, as of the Balance Sheet Date, exceed the reserve for Tax Liability (rather than any reserve for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the face of the Company Balance Sheet (disregarding any notes thereto). The Company has not incurred any Tax Liability since the Balance Sheet Date other than any Tax Liability incurred in the ordinary course of business and consistent with past practice.

(f) The Company has Made Available to Acquiror accurate and complete copies of all Tax Returns filed by the Company on or prior to the date of this Agreement for all Tax periods beginning on or after December 31 , 2002.

(g) There are no agreements relating to the allocating or sharing of Taxes to which the Company is or is to become a party.

(h) The Company is not a member of an affiliated group of corporations within the meaning of Section 1504 of the Code or within the meaning of any similar provision of Law to which the Company may be subject, and has not at any time been a member of an affiliated group of corporations within the meaning of Section 1504 of the Code or within the meaning of any similar provision of Law to which the Company may be subject, other than, prior to January 1, 2004, the affiliated group comprised of the Company together with Abaris, Salus and Summanus.

(i) The Company has not been a United States real property holding corporation within the meaning of Section 897(c)(2) of the Code at any time during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code.

(j) The Company has not agreed nor is it required to make any adjustments pursuant to Section 481(a) of the Code or any similar provision of state, local or foreign Law by reason of a change in accounting method initiated by it or any other relevant party, and the IRS

 

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has not proposed any such adjustment or change in accounting method in writing, nor does the Company have any application pending with any Governmental Entity requesting permission for any changes in accounting methods that relate to the business or Assets of the Company.

(k) No closing agreement pursuant to Section 7121 of the Code (or any predecessor provision) or any similar provision of any state, local or foreign Law has been entered into by or with respect to the Company.

(l) The Company has not participated in a “reportable transaction” within the meaning of Treasury Regulation Section 1.6011-4(b)(1).

(m) There is no agreement, plan, arrangement or other Contract covering any Company Associate that, individually or collectively, could give rise directly or indirectly to the payment of any amount or the provision of any benefit that would not be deductible pursuant to Section 280G or Section 162 of the Code. The grant of Company Stock Options to one of the CIC Employees on October 27, 2005 was not made contingent upon the Merger or any of the Contemplated Transactions for purposes of Section 280G of the Code and the Treasury Regulations thereunder.

(n) The Company is not and has never been a party to or bound by any Tax indemnity agreement, Tax sharing agreement, Tax allocation agreement or similar Contract.

 

2.9 Property

(a) The Company does not own any real property other than the leasehold interests described on Schedule 2.9(a) to the Disclosure Memorandum, which contains an accurate and complete list of all leases of real property currently being used by the Company (the “ Real Property ”). The Company has Made Available to Acquiror or its counsel accurate and complete copies of all written leases, subleases, rental agreements, contracts of sale, tenancies, licenses or other Contracts relating to the Real Property and written summaries of the terms of any oral leases, subleases, rental agreements, contracts of sale, tenancies or licenses to which the Real Property is subject. The Company has not exercised its right of first refusal under the lease for the Company’s headquarters in Seattle, Washington.

(b) Schedule 2.9(b) to the Disclosure Memorandum contains an accurate and complete list of each item of personal property having a value in excess of $50,000 that is owned, leased, rented or used by the Company, other than Company Intellectual Property (the “ Personal Property ”). The Company has Made Available to Acquiror accurate and complete copies of all leases, subleases, rental agreements, contracts of sale, tenancies or licenses to which the Personal Property is subject.

(c) The Real Property and the Personal Property include all the properties and Assets (other than, in the case of the Personal Property, property rights with an individual value of less than $50,000 and Company Intellectual Property) reflected in the Company Balance Sheet (except for such properties or Assets sold since the Balance Sheet Date in the ordinary course of business and consistent with past practice) and all the properties and Assets purchased by the

 

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Company since the Balance Sheet Date (other than, in the case of the Personal Property, property rights with an individual value of less than $50,000 and the Company Intellectual Property). The Real Property and the Personal Property include all material property used in the business of the Company, other than the Company Intellectual Property. The offices and other structures of the Company and the Personal Property that is material to the operation of the Company’s business are in good operating condition and repair, normal wear and tear excepted, and are adequate for the uses to which they are being put.

(d) The leasehold interest of the Company in each parcel of the Real Property is free and clear of all Encumbrances, except for Encumbrances related to Taxes not yet due and payable. Each lease of any portion of the Real Property is valid, binding and enforceable in accordance with its terms against the Company and, to the knowledge of the Company, the other parties thereto and against any other Person with an interest in such Real Property, the Company has performed in all material respects all obligations imposed on it thereunder, and neither the Company nor (to the knowledge of the Company) any other party thereto is in default thereunder, nor is there any event that with notice or lapse of time, or both, would constitute a default thereunder by the Company or (to the knowledge of the Company) any other party. The Company has not granted any lease, sublease, tenancy or license of, or entered into any rental agreement or contract of sale with respect to, any portion of the Real Property.

(e) The Personal Property is free and clear of all Encumbrances, except for Encumbrances related to Taxes not yet due and payable, and, other than leased Personal Property that is so noted on the list supplied pursuant to Section 2.9(b) , the Company owns such Personal Property. Each lease, license, rental agreement, contract of sale or other agreement to which the Personal Property is subject is valid, binding and enforceable in accordance with its terms against the Company and, to the knowledge of the Company, the other parties thereto, the Company has performed in all material respects all obligations imposed on it thereunder, and neither the Company nor, to the knowledge of the Company, any other party thereto is in default thereunder, nor is there any event that with notice or lapse of time, or both, would constitute a default by the Company or, to the knowledge of the Company, any other party thereunder. The Company has not granted any lease, sublease, tenancy or license of any portion of the Personal Property, except in the ordinary course of business and consistent with past practice.

(f) The Company owns, and has good, valid and marketable title, free and clear of any Encumbrances, to all material Assets purported to be owned by it, including: (i) all material Assets reflected on the Company Balance Sheet (other than any Assets sold in the ordinary course of business, consistent with past practices, since the Balance Sheet Date); (ii) all of the Company’s rights under the Contracts identified in Schedule 2.10(a) to the Disclosure Memorandum; and (iii) all other material Assets reflected in the books and records of the Company as being owned by the Company. All of said Assets are owned by the Company free and clear of any Encumbrances.

 

2.10 Material Contracts

(a) Schedule 2.10(a) to the Disclosure Memorandum contains an accurate and complete list of all Company Contracts that constitute Material Contracts. All such Material

 

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Contracts are valid, binding and enforceable (except as to the effect, if any, of the Enforceability Exceptions) in accordance with their terms against the Company and, to the knowledge of the Company, each other party thereto, and are in full force and effect. The Company has performed in all material respects all obligations imposed on it under each Company Contract that constitutes a Material Contract, and neither the Company nor (to the knowledge of the Company) any other party thereto is in default thereunder nor is there any event or circumstance that with notice or lapse of time, or both, could (i) constitute a default by the Company or (to the knowledge of the Company) any other party under any Company Contract that constitutes a Material Contract, (ii) result in a material violation or breach of any of the provisions of any Company Contract that constitutes a Material Contract, (iii) give any Person the right to declare a default or exercise any remedy under any Company Contract that constitutes a Material Contract, (iv) give any Person the right to receive or require a rebate, chargeback, penalty or change in delivery schedule under any Company Contract that constitutes a Material Contract, (v) give any Person the right to accelerate the maturity or performance of any Company Contract that constitutes a Material Contract, or (vi) give any Person the right to cancel, terminate or modify any Company Contract that constitutes a Material Contract.

(b) The Company has not received any notice or other communication (in writing or, to the knowledge of the Company, otherwise) regarding any actual or possible violation or breach of, or default under, any Company Contract that constitutes a Material Contract; and the Company has not waived any of its material rights under any Company Contract that constitutes a Material Contract.

(c) Accurate and complete copies of each written Company Contract that constitutes a Material Contract (and accurate and complete written summaries of the terms of each oral Company Contract that constitutes a Material Contract) have been Made Available to Acquiror by the Company (it being understood that to the extent any Material Contract is based on a standard-form Contract of the Company, the Company has only Made Available the standard-form Contract unless such Material Contract deviates in any material respect from such standard-form Contract, in which case the Company has also provided an accurate and complete copy of such Material Contract as well). Except as set forth in Schedule 2.10(c) to the Disclosure Memorandum, each of the CRO Contracts is terminable and may be discontinued by the Company at will (upon delivery of notice of not more than 90 days) without penalty or cost (other than reimbursement for previously incurred or committed expenses) in connection with the termination by the Company of the applicable research program to which such Contract relates or the preclinical or clinical development program to which such Contract relates.

(d) Each of the Company Contracts entered into to establish a clinical trial at any clinical site conforms in form substantially with the standard form used by the Company as of the date of such Company Contract. To the knowledge of the Company, there has not been any material adverse effect to any clinical trial conducted by the Company resulting in whole or in part from the breach of any such Company Contracts by the clinical site or sponsor participating therein under any such Company Contracts.

(e) Neither (i) the execution, delivery or performance of this Agreement nor (b) the consummation of any of the Contemplated Transactions will constitute or give rise to a default under any Material Contract or require the Consent of any other party to any Material Contract, except for those Consents listed on Schedule 2.10(e) to the Disclosure Memorandum.

 

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(f) Schedule 2.10(f) to the Disclosure Memorandum contains all Company Contracts that relate to the Company’s license and development rights to the Company 1040 Product (the “Product Contracts”), and all such Product Contracts are valid, binding and enforceable (except as to the effect, if any, of the Enforceability Exceptions) in accordance with their terms against the Company, and, to the knowledge of the Company, each other party thereto, and are in full force and effect; the Company has not received any notice or other communication (in writing or, to the knowledge of the Company, otherwise) regarding any actual or possible violation or breach of, or default under any Product Contract, and the Company has not waived any of its material rights under any Product Contract; the Company has Made Available accurate and complete copies of each written Product Contract to Acquiror; and neither the execution, delivery or performance of the 1040 Product Agreement nor the contemplated activities hereunder will constitute or give rise to a default under any Product Contract or require the Consent of any other party to any Product Contract, except for those Consents included in the list on Schedule 2.10(e) to the Disclosure Memorandum.

 

2.11 Corporate Books and Records

The Company has Made Available to Acquiror or its Representatives for their examination accurate and complete copies of (a) the Company Certificate of Incorporation and Company Bylaws as currently in effect, including all amendments thereto, (b) the minute books of the Company and the Predecessor Entities, and (c) the stock transfer books of the Company and the Predecessor Entities. Such minutes reflect all meetings of the Stockholders, the Board of Directors of the Company and any committees thereof since the inception of the Company, as applicable, and such minutes accurately reflect in all material respects the events of and actions taken at such meetings. Such stock transfer books accurately reflect all issuances and transfers of shares of capital stock of the Company since the inception of the Company.

 

2.12 Claims and Legal Proceedings; Orders

(a) Other than the Specified Litigation, there are no claims or Legal Proceedings pending or that have been threatened in writing or (to the knowledge of the Company) otherwise against, or otherwise involving, the Company or affecting its business or any of its Assets.

(b) Other than the Specified Litigation, to the knowledge of the Company, no event has occurred, and no claim, dispute or other condition or circumstance exists, that could reasonably be expected to give rise to or serve as a basis for the commencement of any Legal Proceeding against the Company.

(c) Except in connection with the Specified Litigation: (i) there is no Order to which the Company, or any of the material Assets owned or used by the Company, is subject; (ii) to the knowledge of the Company, none of the Stockholders is subject to any Order that relates to the business of the Company or to any of the material Assets owned or used by the Company;

 

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and (iii) to the knowledge of the Company, no officer or key employee of the Company is subject to any Order that prohibits such officer or employee from engaging in or continuing any conduct, activity or practice relating to the business of the Company.

(d) Except in connection with the Specified Litigation, no event has occurred, and no circumstance or condition exists, that has resulted in, or that will or could reasonably be expected to result in, any claim by any Company Associate for indemnification or reimbursement (other than a claim for reimbursement by the Company, in the ordinary course of business, of travel expenses, accrued vacation or other out-of-pocket expenses of a routine nature incurred by an employee of the Company in the course of performing such employee’s duties for the Company) pursuant to (i) the terms of the Company Certificate of Incorporation or the Company Bylaws, (ii) any indemnification agreement or other Contract between the Company and any such Company Associate, or (iii) any applicable Law.

(e) Neither the Company, nor (to the knowledge of the Company) any Company Associate, has (i) used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns or violated any provision of the Foreign Corrupt Practices Act of 1977, as amended, or (iii) taken any action that would constitute a violation of the Foreign Corrupt Practices Act of 1977, as amended, if the Company were publicly held.

(f) The Company has complied in all respects with all discovery requests in the Specified Litigation, other than (i) pursuant to valid objections that are permitted by Law and have not been overturned, (ii) pursuant to protective orders granted by an applicable court or discovery referee, as described in any order or finding of an applicable court or discovery referee or (iii) with respect to matters currently the subject of a notice of dispute between the Parties.

 

2.13 Bank Accounts; Receivables; Customers

(a) Schedule 2.13(a) to the Disclosure Memorandum provides accurate information with respect to each account maintained by or for the benefit of the Company at any bank or other financial institution.

(b) Schedule 2.13(b) to the Disclosure Memorandum contains an accurate and complete list as of the date of this Agreement of all loans and advances made by the Company to any Company Associate, other than routine travel advances made to employees in the ordinary course of business.

 

2.14 Employee Benefit Plans

(a) Schedule 2.14(a) to the Disclosure Memorandum accurately sets forth, with respect to each individual who is an employee of the Company (including any such employee who is on a leave of absence or on layoff status) as of the date of this Agreement:

(i) the name of such employee and the date as of which such individual was originally hired by the Company;

 

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(ii) such employee’s title;

(iii) the aggregate dollar amount of the cash compensation (including wages, salary, commissions, director’s fees, bonuses, profit-sharing payments and other payments of any type) and a description of non-cash benefits received by such employee from the Company during 2005 and 2006;

(iv) such employee’s annual salary, target bonus, 2005 bonus and accrued 2006 bonus as of the date of this Agreement; and

(v) to the knowledge of the Company, any Governmental Authorization that is held by such employee and that is necessary for or contributes to the operation of the business of the Company;

(b) Schedule 2.14(b) to the Disclosure Memorandum accurately identifies as of the date of this Agreement each former employee of the Company or any Predecessor Entity who is receiving or is scheduled to receive (or whose spouse or other dependent is receiving or is scheduled to receive) any benefits from the Company (or for which the Company may reasonably be held responsible) relating to such former employee’s employment with the Company or such Predecessor Entity; and Schedule 2.14(b) to the Disclosure Memorandum accurately describes such benefits.

(c) The employment of each of the Company Associates employed or engaged by the Company is terminable by the Company at will, without payment of severance or other termination benefits. The Company has Made Available to Acquiror accurate and complete copies of all material employee manuals and handbooks, disclosure materials, policy statements and other materials relating to the employment of the current and former employees of the Company.

(d) To the knowledge of the Company as of the date of this Agreement: (i) no current Company Associate employed or engaged by the Company intends to terminate such Company Associate’s employment or engagement with the Company; (ii) to the knowledge of the Company, no current Company Associate has received a pending offer to join or provide services to a business that may be competitive with the business of the Company; and (iii) no current Company Associate is a party to or is bound by any confidentiality agreement, noncompetition agreement or other Contract (with any Person) that may have an adverse effect on: (A) the performance by such Company Associate of any of his or her duties or responsibilities to the Company; or (B) the business or operations of the Company.

(e) Schedule 2.14(e) to the Disclosure Memorandum accurately sets forth, with respect to each independent contractor of the Company as of the date of this Agreement:

(i) the name of such independent contractor and the date as of which such independent contractor was originally hired by the Company;

 

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(ii) the aggregate dollar amount of the cash compensation (including all payments of any type) and a description of non-cash benefits received by such independent contractor from the Company during 2005 and 2006;

(iii) the terms of compensation of such independent contractor; and

(iv) to the knowledge of the Company, any Governmental Authorization that is held by such independent contractor and that is necessary for the operation of the business of the Company.

(f) None of the current or former independent contractors of the Company could be reasonably reclassified as an employee under current applicable law. There are, and at no time have been, any independent contractors who have provided services to the Company or any ERISA Affiliate for a period of six consecutive months or longer. The Company has never had any temporary or leased employees. No independent contractor of the Company is eligible to participate in any Company Benefit Plan.

(g) The Company is not a party to or bound by, and the Company has never been a party to or bound by, any employment agreement (other than any such agreement relating to at-will employment) or any union contract, collective bargaining agreement or similar Contract.

(h) The Company is not engaged, and the Company has never been engaged, in any unfair labor practice of any nature that could reasonably be expected to give rise to any material Liability or expense. To the knowledge of the Company, there has never been any slowdown, work stoppage, labor dispute or union organizing activity, or any similar activity or dispute, affecting the Company or any of its employees. There is not now pending, and no Person has threatened to commence, any such slowdown, work stoppage, labor dispute or union organizing activity or any similar activity or dispute. No event has occurred, and no condition or circumstance exists, that might reasonably give rise to or provide a basis for the commencement of any such slowdown, work stoppage, labor dispute or union organizing activity or any similar activity or dispute. There are no actions, suits, claims, labor disputes or grievances pending or, to the knowledge of the Company, threatened or reasonably anticipated relating to any labor, safety or discrimination matters involving any Company Associate, including charges of unfair labor practices or discrimination complaints.

(i) Schedule 2.14(i) to the Disclosure Memorandum contains an accurate and complete list as of the date of this Agreement of each material Company Benefit Plan and each Company Employee Agreement. The Company does not intend nor has the Company agreed or committed to (i) establish or enter into any new Company Benefit Plan or Company Employee Agreement, or (i) to modify any Company Benefit Plan or Company Employee Agreement (except to conform any such Company Benefit Plan or Company Employee Agreement to the requirements of any applicable Laws, in each case as previously disclosed to Acquiror in writing or as required by this Agreement).

 

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(j) The Company has Made Available to Acquiror accurate and complete copies of: (i) all documents setting forth the material terms of each Company Benefit Plan and each Company Employee Agreement, including all amendments thereto and all related trust documents; (ii) the three most recent annual reports (Form Series 5500 and all schedules and financial statements attached thereto), if any, required under ERISA, the Code or any other applicable Law in connection with each Company Benefit Plan; (iii) for each Company Benefit Plan that is subject to the minimum funding standards of Section 302 of ERISA, the most recent annual and periodic accounting of Company Benefit Plan Assets; (iv) the most recent summary plan description together with the summaries of material modifications thereto, if any, required under ERISA with respect to each Company Benefit Plan; (v) all material written Contracts relating to each Company Benefit Plan, including administrative service agreements and group insurance Contracts; (vi) all written materials provided to any Company Associate relating to any Company Benefit Plan and any proposed Company Benefit Plans, relating to any amendments, terminations, establishments, increases or decreases in benefits, acceleration of payments or vesting schedules or other events, in each case, that would result in material Liability to the Company or any ERISA Affiliate; (vii) all material correspondence to or from any Governmental Entity relating to any Company Benefit Plan in the possession of the Company or its Representatives; (viii) all insurance policies in the possession of the Company or any ERISA Affiliate pertaining to fiduciary liability insurance covering the fiduciaries for each Company Benefit Plan; and (x) the most recent IRS determination or opinion letter issued with respect to each Company Benefit Plan intended to be qualified under Section 401(a) of the Code.

(k) The Company and the ERISA Affiliates have performed all obligations required to be performed by them under each Company Benefit Plan in all material respects and are not in default or violation of, and the Company has no knowledge of any material default or violation by any other party to, the terms of any Company Benefit Plan, and each Company Benefit Plan has been established and maintained substantially in accordance with its terms and in substantial compliance with all applicable Laws, including ERISA and the Code with respect to each Company Associate. Any Company Benefit Plan intended to be qualified under Section 401(a) of the Code has obtained a favorable determination letter (or opinion letter, if applicable) as to its qualified status under the Code. No “prohibited transaction,” within the meaning of Section 4975 of the Code or Sections 406 and 407 of ERISA, and not otherwise exempt under Section 408 of ERISA, has occurred with respect to any Company Benefit Plan. There are no claims or Legal Proceedings pending, or, to the knowledge of the Company, threatened or reasonably anticipated (other than routine claims for benefits), against any Company Benefit Plan or against the Assets of any Company Benefit Plan involving any Company Associate. The participation by the Company in each Company Benefit Plan (other than any Company Benefit Plan to be terminated prior to the Closing in accordance with this Agreement) can be amended, terminated or otherwise discontinued after the Closing in accordance with its terms, without liability to Acquiror, the Company, or any ERISA Affiliate (other than ordinary administration expenses and any obligations arising from prior operation of such plan), subject to applicable Laws. To the knowledge of the Company, there are no audits, inquiries or Proceedings pending or threatened by the IRS, DOL, or any other Governmental Entity with respect to any Company Benefit Plan. Neither the Company nor any ERISA Affiliate has ever incurred any penalty or Tax with respect to any Company Benefit Plan under Section 502(i) of ERISA, under Sections 4975 through 4980 of the Code, or under any other applicable Law. No Company Associate is entitled to compensation for any excise Tax imposed by Section 4999 of the Code.

 

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(l) Neither the Company nor any ERISA Affiliate has ever maintained, established, sponsored, participated in, or contributed to any: (i) Company Pension Plan subject to Title IV of ERISA; or (ii) “multiemployer plan” within the meaning of Section (3)(37) of ERISA. Neither the Company nor any ERISA Affiliate has ever maintained, established, sponsored, participated in or contributed to, any Company Pension Plan in which stock of the Company or any ERISA Affiliate is or was held as a plan asset. The fair market value of the Assets of each funded Foreign Plan, the liability of each insurer for any Foreign Plan funded through insurance, or the book reserve established for any Foreign Plan, together with any accrued contributions, is sufficient to procure or provide in full for the accrued benefit obligations with respect to all current and former participants in such Foreign Plan according to the actuarial assumptions and valuations most recently used to determine employer contributions to and obligations under such Foreign Plan, and none of the Contemplated Transactions shall cause any such Assets or insurance obligations to be less than such benefit obligations.

(m) No Company Benefit Plan provides (except at no cost to the Company or any ERISA Affiliate), or reflects or represents any Liability of the Company or any ERISA Affiliate to provide, retiree life insurance, retiree health benefits or other retiree employee welfare benefits to any Company Associate for any reason, except as may be required by COBRA or other applicable Laws. Other than commitments made that involve no future costs to the Company or any ERISA Affiliate, neither the Company nor any ERISA Affiliate has ever represented, promised or contracted (whether in oral or written form) to any Company Associate (either individually or to Company Associates as a group) or any other Person that such Company Associate or other person would be provided with retiree life insurance, retiree health benefit or other retiree employee welfare benefits, except to the extent required by applicable Laws.

(n) Except as expressly required or provided by this Agreement, neither the execution of this Agreement nor the consummation of any of the Contemplated Transactions will (either alone or upon the occurrence of any additional or subsequent events) constitute an event under any Company Benefit Plan, Company Employee Agreement, trust or loan that will or may result in any material payment (whether of severance pay or otherwise), acceleration, forgiveness of indebtedness, vesting, distribution, increase in benefits or obligation to fund benefits with respect to any Company Associate.

(o) The Company and the ERISA Affiliates: (i) are, and at all times have been, in substantial compliance with all applicable Laws respecting employment, employment practices, terms and conditions of employment and wages and hours, in each case, with respect to Company Associates, including the health care continuation requirements of COBRA, the requirements of FMLA, the requirements of HIPAA and the provisions of similar Laws; (ii) have withheld and reported all amounts required by applicable Laws to be withheld and reported with respect to wages, salaries and other payments to Company Associates; (iii) are not liable for any arrears of wages or any Taxes or any penalty for failure to comply with the Laws applicable of the foregoing; and (iv) are not liable for any payment to any trust or other fund governed by or

 

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maintained by or on behalf of any Governmental Entity with respect to unemployment compensation benefits, social security or other benefits or obligations for Company Associates (other than routine payments to be made in the normal course of business and consistent with past practice). There are no pending or, to the knowledge of the Company, threatened or reasonably anticipated claims or Proceedings against the Company or any ERISA Affiliate under any worker’s compensation policy or long-term disability policy.

(p) To the knowledge of the Company, no Company Associate is obligated under any Contract or subject to any judgment, decree, or order of any court or other Governmental Entity that would interfere with such Person’s employment with the Company or that would interfere with the business of the Company or any ERISA Affiliate. Neither the execution nor the delivery of this Agreement, nor the carrying on of the business of the Company or any ERISA Affiliate as currently conducted nor any activity of such Company Associates in connection with the carrying on of the business of the Company or any ERISA Affiliate as currently conducted will, to the knowledge of the Company, conflict with, result in a breach of the terms, conditions or provisions of, or constitute a default under, any Contract under which any of such Company Associates is now bound.

 

2.15 Intellectual Property

(a) Schedule 2.15(a) to the Disclosure Memorandum accurately identifies all Patent Rights included within the Company Intellectual Property necessary or currently intended for use in the manufacture, development or commercialization of the Company 1020 Product that is owned by or licensed to the Company (all such Patent Rights required to be identified in Schedule 2.15(a) to the Disclosure Memorandum being referred to as “ Product IP ”), and, for each item of Product IP: (i) whether it is Product IP that is registered, filed or issued under the authority of, with or by any governmental body, including all patents, registered copyrights and registered trademarks and all applications for and of the foregoing (“ Registered IP ”), and if it is Registered IP the jurisdiction in which such item of Registered IP has been registered or filed and the applicable registration or serial number; (ii) the identity of any other Person that has an ownership interest in such item of Product IP and the nature of such ownership interest; (iii) the identity of any license agreement or other Contract under which the Company has obtained rights in such item of Product IP; and (iv) any Contract pursuant to which the Company has granted or made any license, material right (including any right to receive any royalty payment, milestone payment, success payment or maintenance fee or similar fee) or material Encumbrance to, under or in connection with such item of Product IP to or in favor of any other Person.

(b) Schedule 2.15(b) to the Disclosure Memorandum accurately identifies all Patent Rights included within the Company Intellectual Property that are not identified in Schedule 2.15(a) to the Disclosure Memorandum, together with all registered and unregistered trademarks, trade names and service marks, and registered copyrights included in the Company Intellectual Property, and for each item identified in Schedule 2.15(b) : (i) whether it is Registered IP, and if it is Registered IP the jurisdiction in which such item of Registered IP has been registered or filed and the applicable registration or serial number; (ii) the identity of any other Person that has an ownership interest in such item of Company Intellectual Property and the nature of such ownership interest; (iii) the identity of any license agreement under which the

 

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Company has obtained rights in such item of Company Intellectual Property; and (iv) any Contract pursuant to which the Company has granted or made any license, material right (including any right to receive any royalty payment, milestone payment, success payment or maintenance fee or similar fee) or material Encumbrance to, under or in connection with such item of Company Intellectual Property to or in favor of any other Person.

(c) The Company has obtained the unconditional and irrevocable assignment of all Patent Rights, and an unlimited assignment of or unrestricted license under all other Intellectual Property Rights, in each case without further payment obligation, developed by or on behalf of Teva or Plantex or any Affiliate of either such company arising out of services performed under arrangements with the Company or any current or former Affiliate of the Company in connection with aztreonam lysine or the manufacture thereof. Such assignments have been duly recorded in the patent office of the respective countries in which the patent applications have been filed, and have transferred to the Company the full right, title and interest in and to the subject patent applications.

(d) The Company has sufficient right, title and interest in and to the Company Intellectual Property:

(i) to conduct the business of the Company in an unrestricted manner in substantially the same manner as currently conducted or as currently proposed to be conducted by the Company, including the development, manufacture and sale of the Company 1020 Product on a worldwide basis in accordance with the current plans of the Company (A) with no payment obligations to any Person or with respect to any Company Intellectual Property other than as set forth in any license agreement listed in Schedule 2.15(a) to the Disclosure Memorandum and (B) without infringing (directly, contributorily, by inducement or otherwise), misappropriating or otherwise violating any Intellectual Property Rights of any other Person; and

(ii) to exclude all other Persons from making, having made, importing, offering for sale, selling or otherwise developing and commercializing the Company 1020 Product in the countries listed in Schedule 2.15(a) to the Disclosure Memorandum to the extent allowable by any such country.

(e) Euticals has sufficient right, title and interest in and to Intellectual Property Rights to manufacture and sell to the Company the active pharmaceutical ingredient aztreonam in accordance with the Euticals Agreement, using its current manufacturing process and with the specifications currently in effect as well as any other specifications contemplated by the Company, without infringing (directly, contributorily, by inducement or otherwise), misappropriating or otherwise violating any Intellectual Property Rights of any other Person.

(f) PARI has sufficient right, title and interest in and to Intellectual Property Rights to develop, manufacture and sell PARI Devices to the Company in accordance with the PARI Agreement, using its current manufacturing methodologies, without infringing (directly, contributorily, by inducement or otherwise), misappropriating or otherwise violating any Intellectual Property Rights of any other Person.

 

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(g) Each granted claim of the Patent Rights included within the Company Intellectual Property is valid, subsisting and enforceable.

(h) Nothing contained in the Development Agreement dated April 3, 2003, between Abaris and PARI, or any other Contract between the Company or any Affiliate of the Company with PARI, limits or modifies the rights of the Company set forth in the PARI Agreement.

(i) Schedule 2.15(i) to the Disclosure Memorandum accurately identifies (A) all Persons who participated under arrangements with the Company or otherwise in connection with the Company in the development of a formulation of aztreonam, or the manufacturing process for the active pharmaceutical ingredient aztreonam or a formulation of aztreonam (other than any Person whose participation was immaterial in nature and who has not acquired any rights of any nature in or with respect to the Company 1020 Product), and (B) any Contract pursuant to which such development or manufacturing work was conducted. Except as expressly set forth on Schedule 2.15(i) , all such Persons identified or required to be identified on Schedule 2.15(i) have unconditionally and irrevocably assigned to the Company, or granted the Company an unrestricted license under, all of the right, title and interest in Intellectual Property Rights developed in the course of such work, without restriction or further payment obligation on the part of the Company.

(j) The execution, delivery and performance of this Agreement will not, with or without notice or the lapse of time, result in or give any other Person the right or option to cause or declare: (A) a loss of, or Encumbrance on, any Company Intellectual Property; (B) a breach of any Contract listed or required to be listed in Schedule 2.15(a) or Schedule 2.15(i) to the Disclosure Memorandum; (C) the release, disclosure or delivery of any Company Intellectual Property by or to any escrow agent or other Person; or (D) the grant, assignment or transfer to any other Person of any license or other right or interest under, to or in any of the Company Intellectual Property. Schedule 2.15(j) to the Disclosure Memorandum identifies any Consent that that Company was, is or will be required to obtain from any Person under any Contract related to the Company 1020 Product listed or required to be listed in Schedule 2.15(a) or Schedule 2.15(i) to the Disclosure Memorandum in connection with the execution, delivery or performance of this Agreement or the consummation of the Merger or any other transaction contemplated by this Agreement.

(k) No Person has infringed, misappropriated or otherwise violated, and no Person is currently infringing, misappropriating or otherwise violating, any Company Intellectual Property. Schedule 2.15(k) to the Disclosure Memorandum accurately identifies in all material respects each written or electronic communication or correspondence that has been sent or otherwise delivered by or to any party to a Contract listed or required to be listed in Schedule 2.15(a) or Schedule 2.15(i) to the Disclosure Memorandum, or any Representative of any such other party to such a Contract, regarding any actual, alleged or suspected infringement or misappropriation of any Company Intellectual Property and provides a brief description of the current status of the matter referred to in such letter, communication or correspondence.

 

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(l) With respect to the Company 1020 Product: (i) the Company has never infringed (directly, contributorily, by inducement or otherwise), misappropriated or otherwise violated any Intellectual Property Right of any other Person, and (ii) none of the parties to any of the Contracts listed or required to be listed in Schedule 2.15(a) or Schedule 2.15(i) to the Disclosure Memorandum has, with respect to their activities related to the Company or the Company 1020 Product, infringed (directly, contributorily, by inducement or otherwise), misappropriated or otherwise violated any Intellectual Property Right of any other Person.

(m) Other than the Specified Litigation, no adversarial Legal Proceeding involving any Intellectual Property Right owned by or licensed to the Company is or at any time has been pending, or to the knowledge of the Company is or at any time has been threatened.

(n) Other than the Specified Litigation:

(i) there are no claims or Legal Proceedings that have been brought by or on behalf of the Company, asserting that:

(A) any Person bound by a Company Contract affecting or relating to the protection or disclosure of the Company Intellectual Property related to the Company 1020 Product has breached such Company Contract;

(B) any Person has acquired, disclosed or misused the Company 1020 Product in violation of any such Company Contract; or

(C) any Person has acquired, disclosed or misused the Company 1020 Product in violation of any Legal Requirement; and

(ii) there are no claims or Legal Proceedings that have been made, brought or threatened against the Company, or have been made, brought or threatened against an employee of the Company or any other Person identified or required to be identified on Schedule 2.15(a) or Schedule 2.15(j) to the Disclosure Memorandum, asserting that any such Person has breached any Contract affecting or relating to the protection or disclosure of the Company 1020 Product, or otherwise improperly disclosed, acquired or misused a trade secret, that, if adversely determined, could reasonably be expected to materially and adversely affect the development, manufacturing, use, distribution or sale of the Company 1020 Product.

(o) The Company has taken all commercially reasonable steps to protect and preserve the confidentiality of all of the Company’s confidential information. Each employee, consultant and independent contractor of the Company has entered into a proprietary information and confidentiality agreement, specifying no exceptions of any nature, substantially in the Company’s standard form applicable to employees, consultants and independent contractors, as the case may be, which forms have been Made Available to Acquiror.

(p) The Company has sufficient right, title and interest in and to the Company Intellectual Property to make, have made, use, sell, offer for sale and import the Company 1040 Product in an unrestricted manner and to transfer such rights to research, develop and commercialize the Company 1040 Product to Acquiror as contemplated in the 1040 Product

 

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Agreement; the Company has not granted any right to any other Person, and will not grant any right to any other Person during the term of the 1040 Product Agreement, that would conflict with the rights granted to the Acquiror under the 1040 Product Agreement; and the Company has never infringed (directly, contributorily, by inducement or otherwise), misappropriated or otherwise violated any Intellectual Property Rights of any other Person in connection with the Company’s manufacture, research and development activities relating to the Company 1040 Product, either through its internal research program or through a third party contractor.

 

2.16 Compliance with Laws

The Company is and has at all times been in compliance in all material respects with all Laws and Orders applicable to it, all Laws and Orders applicable to its employees and all Laws and Orders applicable to the Real Property and the Personal Property, including, as and to the extent specified in Section 2.15 , all such Laws and Orders relating to intellectual property protection, and including, as and to the extent specified in Section 2.20 , all such Laws and Orders relating to environmental protection, and also including all such Laws and Orders relating to antitrust matters, consumer protection, currency exchange, equal employment opportunity, health and occupational safety, pension and employee benefit matters, securities and investor protection matters, labor and employment matters and trading-with-the-enemy matters. The Company has not received any written notification of any asserted unremedied failure by the Company to comply with any such Law or Order.

 

2.17 Insurance

Schedule 2.17 to the Disclosure Memorandum sets forth an accurate and complete list of all insurance policies maintained by or for the benefit of the Company and includes the policy number, amount of coverage and contact information for each such policy. All such insurance policies are in full force and effect, all premiums with respect thereto covering all periods up to and including the date this representation is made have been paid, and no notice of cancellation or termination has been received with respect to any such policy or binder. Such policies or binders are sufficient for compliance with all requirements of Law currently applicable to the Company and with all agreements to which the Company is a party, will remain in full force and effect through the respective expiration dates of such policies or binders without the payment of additional premiums, and will not in any way be affected by, or terminate or lapse by reason of, any of the Contemplated Transactions. The Company has not been refused any insurance with respect to its Assets or operations, nor has its coverage been limited, by any insurance carrier to which it has applied for any such insurance or with which it has carried insurance. The Company has not received any notice or other communication (in writing or, to the knowledge of the Company, otherwise) regarding any (a) cancellation or invalidation of any insurance policy identified or required to be identified in Schedule 2.18 to the Disclosure Memorandum, (b) refusal of any coverage or rejection of any claim under any such insurance policy, or (c) material increase in the amount of the premiums payable with respect to any such insurance policy.

 

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2.18 Brokers or Finders

Except for the investment banking fees of the Independent Advisor pursuant to that certain engagement letter dated April 20, 2005, a copy of which has been provided to Acquiror, the Company has not incurred, and will not incur, directly or indirectly, as a result of any action taken by or on behalf of the Company, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Merger, this Agreement or the other Operative Documents or any of the other Contemplated Transactions.

 

2.19 Insider Interests

(a) No Related Party has any interest (other than as a Stockholder) (i) in any Real Property, Personal Property or Company Intellectual Property used in or directly pertaining to the business of the Company, including inventions, patents, trademarks or trade names, or (ii) in any Contract relating to the Company, its present or prospective business or its operations other than offer letters, employment agreements, option agreements and other agreements and arrangements incident to employment relationships in the ordinary course of business and consistent with past practice.

(b) There are no agreements, understandings or proposed transactions between the Company and any of the Related Parties.

(c) Neither the Company nor any Related Party has any interest, either directly or indirectly, in any other Entity (whether as an employee, officer, director, stockholder, agent, independent contractor, security holder, creditor, consultant or otherwise) that (i) provides any services, produces or sells any products or product lines, or engages in any activity that is the same, similar to or competitive with any activity or business in which the Company is now engaged or proposes to engage, (ii) is a supplier, customer or creditor or (iii) has any direct or indirect interest in any properties or Assets of the Company or any property or Asset that is necessary or desirable for the business of the Company as currently conducted or as currently proposed to be conducted by the Company.

 

2.20 Compliance With Environmental Laws

(a) The Company has not received written notice of actual or threatened material liability under CERCLA or any similar state or local statute or ordinance from any Governmental Entity or any third party.

(b) The Company has not entered into or agreed to enter into, nor does it contemplate entering into, any Order, and the Company is not subject to any Order relating to compliance with any applicable Environmental Laws.

(c) The Company has not received written notice that it is subject to any material Liability incurred or imposed or based on any provision of any Environmental Law and arising out of any act or omission of the Company, or any of its employees, agents or Representatives.

 

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(d) To the knowledge of the Company, the Company possesses all material permits and other Governmental Authorizations required under applicable Environmental Laws, and is in material compliance with the terms and conditions thereof. The Company has not received any notice or other communication (in writing or, to the knowledge of the Company, otherwise), whether from a Governmental Entity, citizens group, employee or otherwise, that alleges that the Company is not in compliance in all material respects with any Environmental Law. To the knowledge of the Company, (a) all real property that is leased to and occupied or controlled by the Company, and all surface water, groundwater and soil associated with or adjacent to such property, is free of any material environmental contamination of any nature, (b) none of the property leased to and occupied or controlled by the Company contains any underground storage tanks, asbestos, equipment using PCBs, underground injection wells, and (c) none of the property leased to and occupied or controlled by the Company contains any septic tanks in which process wastewater or any Hazardous Materials have been disposed of.

 

2.21 Governmental Authorizations; Regulatory Matters

(a) The Company holds all material Governmental Authorizations necessary to enable the Company to conduct its business in the manner in which such business is currently conducted or as currently proposed to be conducted by the Company. The Company has not received any written notifications of any asserted failure by it to have obtained any such Governmental Authorization, or any past and unremedied failure to obtain any such Governmental Authorizations. All regulatory filings made with respect to the Company’s products have been accurate and complete and have complied in all material respects with all applicable Laws. All clinical trials of investigational products have been and are being conducted by the Company according to the applicable Laws in all material respects, together with appropriate monitoring of clinical investigator trial sites for their compliance. The Company has disclosed to Acquiror all regulatory filings and all material communications between Representatives of the Company and any regulatory agency or other Governmental Entity.

(b) The Company 1020 Product has been and is being developed, tested, manufactured, labeled, stored and distributed in compliance in all material respects with all applicable Laws, including those relating to investigational use, premarket clearance, good manufacturing practices, good clinical practices, good laboratory practices, recordkeeping, filing of reports and security.

(c) The Company has Made Available to Acquiror (i) accurate and complete copies of each Investigational New Drug Application (“ IND ”) and each similar state or foreign regulatory filing made on behalf of the Company, including all related supplements, amendments and annual reports, and (ii) all material correspondence received from the FDA, the EMEA or any similar state or foreign Governmental Entity that concerns the Company 1020 Product. The Company has accurately described in all material respects to Acquiror the nature and content of all material verbal communications with representatives of the FDA, the EMEA and any similar state and foreign Governmental Entities that could reasonably be expected to materially affect the prospect for approval of the Company 1020 Product.

 

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(d) The Company has no knowledge of any facts or circumstances that could reasonably be construed as indicating that marketing approval for the Company 1020 Product (including the modified eFlow inhalation device contemplated by the eKey Agreement between PARI and the Company dated May 18, 2005) will not be obtained in the United States or the countries of the European Union on the schedule, and for the target patient population, contemplated by the Company’s current executive summary attached as Schedule 2.21(d) to the Disclosure Memorandum, assuming that the primary endpoint(s) required by the FDA for the Company’s current clinical trials is achieved, without the commencement of clinical trials not currently underway or the collection of data not being collected in the Company’s current clinical trials.

(e) The Company 1020 Product has been designated as an Orphan Drug by the FDA (for inhaled aztreonam) and the European Medicines Agency (the “ EMEA ”) (for aztreonam lysinate). Such designations remain in full force and effect and the Company has no knowledge of any facts or circumstances that could reasonably be construed as indicating that they may be rescinded or modified.

(f) The Company has Made Available to Acquiror in an accurate and complete manner all clinical data from clinical trials (including all adverse events) known to the Company regarding the Company 1020 Product.

(g) The Company has not made an untrue statement of a material fact or fraudulent statement to the FDA, the EMEA or any similar state or foreign Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA, the EMEA or any similar state or foreign Governmental Entity, or committed an act, made a statement or failed to make a statement, that (in any such case) establishes a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the EMEA or any similar state or foreign Governmental Entity to invoke any similar policy. The Company has not, and no officer, employee or agent of the Company or principal investigator or sub-investigator of any clinical investigation sponsored by the Company has, on account of actions taken for or on behalf of the Company, been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign Law or under 21 U.S.C. Section 335a(b) or any similar state or foreign Law.

(h) Neither the Company 1020 Product nor (to the knowledge of the Company) any PARI inhalation device containing the same functionality as either of the PARI Devices has been recalled, suspended or discontinued as a result of any action by the FDA, the EMEA or any similar state or foreign Governmental Entity. No clinical trial of the Company 1020 Product has been suspended, put on hold or terminated prior to completion, and no IND for the Company 1020 Product has been suspended, withdrawn, rejected or refused, in each case, as a result of any action by the FDA, the EMEA or any similar state or foreign Governmental Entity or voluntarily by the Company based on serious adverse effects on human health. Neither the Company nor any of its collaborators has received any written notice or other communication indicating that the FDA, the EMEA or any similar state or foreign Governmental Entity has commenced or threatened to initiate any action to withdraw approval, terminate clinical development, request the recall of the Company 1020 Product, or to enjoin or place any material restriction on the production, sale, marketing, reimbursement or testing of the Company 1020 Product.

 

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2.22 Vote Required

The affirmative votes of the holders of (a) a majority of the outstanding shares of Company Common Stock and Company Preferred Stock, voting together as a single class, and (b) sixty-six and two-thirds (66-2/3%) in interest of the outstanding shares of Company Preferred Stock (the votes referred to in clauses “(a)” and “(b)” of this sentence being referred to collectively as the “ Required Company Stockholder Vote ”) are the only votes of the holders of any class or series of the Company’s capital stock necessary to adopt this Agreement or approve the Merger and the other Contemplated Transactions. Acquiror is entitled, pursuant to the Company Certificate of Incorporation, the Company Bylaws and Applicable Law, to vote the Acquiror-Held Series C Shares in favor of the adoption of this Agreement, and such vote will be valid and enforceable. The Key Stockholders collectively own of record (and will continue to own of record at all times through the Closing) a sufficient number of shares of Company Capital Stock to obtain the Required Company Stockholder Vote. The Required Company Stockholder Vote shall have been obtained upon the execution and delivery of the Stockholder Consent by or on behalf of each of the Key Stockholders, whether or not any other Stockholder executes and delivers the Stockholder Consent, and the Stockholder Consent shall remain in full force and effect at all times during the Pre-Closing Period.

 

2.23 Inventories and Supply

(a) Schedule 2.23 to the Disclosure Memorandum provides, as of the date of this Agreement, (i) in Schedule 2.23(i) to the Disclosure Memorandum, an accurate and complete summary in all material respects (by quantity and expiration/retest date) of the Company’s inventories of bulk aztreonam manufactured by Euticals under the Euticals Agreement, formulated and lyophilized by Ben Venue under the Ben Venue Terms and Conditions and of finished and packaged aztreonam manufactured by Fisher Clinical Services (successor in interest to McKesson BioServices Corporation) and (ii) in Schedule 2.23(ii) to the Disclosure Memorandum, an accurate and complete summary in all material respects (by quantity and delivery date for each such order) of the Company’s outstanding firm orders placed with, and accepted by, Euticals (with respect to bulk aztreonam), Ben Venue (with respect to formulation and lyophilization) and Fisher Clinical Services (with respect to finished and packaged aztreonam). The inventories referred to above in this subsection were manufactured by each of Euticals and Ben Venue in accordance with the requirements of and warranties specified in the Euticals Agreement and Ben Venue Terms and Conditions, respectively.

(b) The total of the Company’s inventories of bulk aztreonam and finished and packaged aztreonam, plus the quantities thereof represented by Company’s firm orders therefor, are reasonably sufficient for the conduct of all clinical trials being conducted by or on behalf of the Company thereon through June 30, 2007.

(c) Euticals has sufficient available capacity in the facility it is currently using for the manufacture of aztreonam to supply the Company with quantities of commercial grade

 

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aztreonam manufactured in accordance with the specifications required by the Euticals Agreement sufficient to meet the foreseeable worldwide commercial requirements of the Company. Such facility has been approved by the FDA and the EMEA for the supply of other human pharmaceutical products, and the Company has no knowledge of any facts or circumstances that could reasonably be construed as indicating that such facility will not be approved by such Governmental Entities in the ordinary course for the supply of aztreonam.

 

2.24 Covenants in Other Agreements

The Company has duly performed in all material respects all covenants required to be performed by it as set forth in the Joint Defense Agreement, the 1040 Product Agreement and the other Operative Documents.

 

2.25 Full Disclosure

(a) This Agreement (including the Disclosure Memorandum) does not, none of the certificates referred to in Article IV will, and none of the Operative Documents do or will, (i) contain any representation, warranty or information that is false, misleading or incomplete with respect to any material fact, or (ii) omit to state any material fact necessary in order to make the representations, warranties and information contained and to be contained herein and therein (in the light of the circumstances under which such representations, warranties and information were or will be made or provided) not false, misleading or incomplete; provided, however , that the Company makes no representation as to any representations or warranties of, or any information provided by, Acquiror or Merger Sub in or with respect to this Agreement or any of the other Operative Documents.

(b) On the date it is delivered to the Stockholders, the Information Statement (i) will comply with all applicable Laws, (ii) will not contain any information that is false, misleading or incomplete with respect to any material fact, or (iii) will not omit to state any material fact necessary in order to make the information contained in the Information Statement (in the light of the circumstances under which such information was provided) not false, misleading or incomplete; provided, however , that the Company makes no representation as to any information with respect to Acquiror provided by Acquiror for inclusion in the Information Statement.

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF ACQUIROR AND MERGER SUB

Acquiror and Merger Sub represent and warrant to the Company as of the Secondary Period Commencement Date and as of the Closing Date as follows in this Article III .

 

3.1 Organization

Each of Acquiror and Merger Sub (a) is a corporation duly organized, validly existing and in good standing under the Laws of its jurisdiction of incorporation, (b) has all requisite corporate power and authority to own, operate and lease its properties and Assets, and to carry on its respective business as currently conducted or as currently proposed to be conducted by

 

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Acquiror or Merger Sub, and (c) is duly qualified and licensed as a foreign corporation to do business and is in good standing (with respect to jurisdictions that recognize such concept) in each jurisdiction in which the character of its properties occupied, owned or held under lease or the nature of the business it conducts makes such qualification or licensing necessary. All the issued and outstanding shares of capital stock of Merger Sub are held of record and beneficially by Acquiror.

 

3.2 Enforceability

Each of Acquiror and Merger Sub has full corporate power and authority to execute, deliver and perform this Agreement and the other Operative Documents to which it is or is to become a party, and to consummate the Contemplated Transactions. All corporate action on the part of Acquiror and Merger Sub and their respective officers, directors and stockholders necessary for the authorization, execution, delivery and performance of this Agreement and the other Operative Documents to which Acquiror or Merger Sub is or is to become a party, the consummation of the Merger and the performance of all of their respective obligations under this Agreement and the other Operative Documents to which Acquiror or Merger Sub is or is to become a party has been taken or will be taken prior to the Effective Time. This Agreement has been, and each of the other Operative Documents to which Acquiror or Merger Sub is or is to become a party will have been, at the Closing, duly executed and delivered by Acquiror and Merger Sub, as applicable, and this Agreement is, and each of the other Operative Documents to which Acquiror or Merger Sub is or is to become a party will be, at the Closing, a legal, valid and binding obligation of Acquiror or Merger Sub, as applicable, enforceable against Acquiror or Merger Sub, as applicable, in accordance with its terms, except as to the effect, if any, of the Enforceability Exceptions.

 

3.3 No Approvals; No Conflicts

The execution, delivery and performance by Acquiror and Merger Sub, as applicable, of this Agreement and the other Operative Documents to which it is or is to become a party, the consummation by them of the Contemplated Transactions, the effectiveness of the Merger and the performance by Acquiror and Merger Sub of their respective obligations pursuant to this Agreement and the other Operative Documents to which it is or is to become a party will not (a) constitute a violation (with or without the giving of notice or lapse of time, or both) of any provision of Law or any Order applicable to Acquiror or Merger Sub; (b) require any consent, approval or authorization of, or declaration, filing or registration with, any Person, except (i) the filing of all documents necessary to consummate the Merger with the Delaware Secretary and (ii) any required submissions under the HSR Act that the Company or Acquiror determines must be made, in each case, with respect to the Merger and the other contemplated transactions; (c) result in a default (with or without the giving of notice or lapse of time, or both) under any material agreement to which Acquiror or any of its Subsidiaries is a party or by which it is bound or to which any Assets of Acquiror or any of its Subsidiaries are subject; or (d) conflict with or result in a breach of or constitute a default under any provision of the Certificate of Incorporation, as amended, or Bylaws of Acquiror or the Certificate of Incorporation or Bylaws of Merger Sub.

 

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3.4 Brokers or Finders

Acquiror has not incurred, and will not incur, directly or indirectly, as a result of any action taken by or on behalf of Acquiror, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Merger, this Agreement or the other Operative Documents or any transaction contemplated hereby or thereby that would result in a claim against the Company or the Stockholders.

 

3.5 Available Cash

Acquiror and Merger Sub will at the Closing have sufficient funds available to them to pay the consideration payable pursuant to Sections 1.7.1(b)(i) , 1.7.1(c)(i) , 1.7.1(d)(i) and 1.7.1(e)(i) and to consummate the Contemplated Transactions.

 

3.6 Information Supplied by Acquiror

None of the information with respect to Acquiror or Merger Sub to be provided by Acquiror or Merger Sub in writing expressly for inclusion in the Information Statement will contain any information that is false, misleading or incomplete in any material respect with respect to any material fact as of the date on which such information is provided; provided, however , that Acquiror makes no representation as to any information provided by the Company for inclusion in the Information Statement.

ARTICLE IV

CONDITIONS PRECEDENT TO OBLIGATIONS OF ACQUIROR AND MERGER SUB

The obligations of Acquiror and Merger Sub to effect the Merger and otherwise consummate the Contemplated Transactions shall be subject to the satisfaction at or prior to the Closing of the following conditions, which may be expressly waived only in a writing signed by Acquiror and Merger Sub:

 

4.1 Accuracy of Representations and Warranties

Each of the representations and warranties of the Company set forth in this Agreement or in any of the other Operative Documents (i) shall have been accurate in all material respects as of the Secondary Period Commencement Date as if made on and as of the Secondary Period Commencement Date, and (ii) shall be accurate in all material respects as of the Closing Date as if made on and as of the Closing Date (except that any representation and warranty that is made exclusively as of, and that refers specifically to, a specified date need only have been accurate in all material respects as of such specified date); provided, however, that: (1) in determining the accuracy of such representations and warranties for purposes of this Section 4.1 , no effect shall be given to any “Company Material Adverse Effect” or other materiality qualifications, or any similar qualifications, that are contained or incorporated directly or indirectly in such representations or warranties and that would otherwise limit the scope or effect of such representations or warranties, and (2) any update of or modification to the Disclosure Memorandum made or purported to have been made on or after the Secondary Period Commencement Date shall be disregarded.

 

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4.2 Performance of Agreements

The Company shall have performed in all material respects each obligation and agreement, and complied with each covenant, contained in this Agreement or any other Operative Document to be performed or complied with by the Company at or prior to the Closing.

 

4.3 Compliance Certificate

Acquiror shall have received a certificate of the President and the Chief Financial Officer of the Company, dated the Closing Date, in form and substance reasonably satisfactory to Acquiror:

(a) certifying, representing and warranting that the conditions set forth in Sections 4.1 , 4.2 , 4.8 , 4.10 , 4.13 and 4.14 have been duly satisfied; provided, however , that the certifications to Sections 4.13 and 4.14 shall be made to the knowledge of the Company; and

(b) certifying, representing and warranting as to the accuracy and completeness of the Closing Payment Schedule (subject to the final proviso of Section 1.8 ).

 

4.4 Proceedings and Documents; Secretary’s Certificate

Acquiror shall have received a certificate of the Secretary of the Company, in form and substance reasonably satisfactory to Acquiror, certifying, representing and warranting as to the authenticity and effectiveness of the actions of the Board of Directors of the Company and the Stockholders and the authorization by the Company of the Merger and the other Contemplated Transactions, and as to the accuracy and completeness of the copies of (a) the Company Certificate of Incorporation, certified by the Delaware Secretary, (b) the Company Bylaws, (c) the resolutions of the Board of Directors of the Company relating to the Contemplated Transactions and (d) the Stockholder Consent, attached to such certificate.

 

4.5 Approvals and Consents

(a) All permits, licenses and other Governmental Authorizations and all notices to Governmental Entities required in connection with the Contemplated Transactions, or for the continued operation of the Company, shall have been obtained and made and shall be in full force and effect, and all waiting periods specified by Law shall have expired or been terminated.

(b) The consummation of the Merger will not result in the violation of any Law or Order.

(c) The applicable waiting periods, together with any extensions thereof, under the HSR Act or any other applicable pre-clearance requirement of any foreign competition Law shall have expired or been terminated, and any Consent required under any applicable foreign competition Law in connection with any of the Contemplated Transactions shall have been obtained and shall be in full force and effect.

 

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(d) All of the Consents identified in Annex 4.5(d) , and any other material Consents required for or in connection with the consummation of any of the Contemplated Transactions (other than any Consent that Acquiror has agreed in writing may be omitted from Annex 4.5(d) ), shall have been obtained and shall be in full force and effect.

 

4.6 Legal Proceedings

(a) No Order of any Governmental Entity shall be in effect that enjoins, restrains, conditions or prohibits consummation of the Merger or any of the other Contemplated Transactions.

(b) Other than the Specified Litigation, no Legal Proceeding shall be pending or threatened (a) seeking a material amount of damages in connection with the Merger or any of the other Contemplated Transactions, (b) seeking to prohibit or limit the exercise by Acquiror of any material right pertaining to its ownership of stock of Merger Sub or the Surviving Corporation, (c) challenging, or that may have the effect of preventing, delaying, restraining, making illegal or otherwise interfering with, the Merger or any of the other Contemplated Transactions, or (d) seeking to compel the Company, Acquiror or any Subsidiary of Acquiror to dispose of or hold separate any material Assets as a result of the Merger or any of the other Contemplated Transactions.

(c) There shall not have been any Law enacted or deemed applicable to the Merger that makes consummation of the Merger illegal.

 

4.7 Stockholder Approval

This Agreement shall have been duly adopted and the Merger shall have been duly approved by the Required Company Stockholder Vote, and all of the Key Stockholders, in their capacities as stockholders of the Company, shall have executed and delivered the Stockholder Consent personally or by proxy. The number of shares of Company Capital Stock that are or that may become Dissenting Shares shall be less than 5% of the number of shares of Company Capital Stock outstanding immediately prior to the Closing.

 

4.8 No Company Material Adverse Effect

Since the last day of the most recent fiscal quarter of the Company prior to the commencement of the Secondary Period for which financial statements of the Company are available, except for any matters expressly set forth in Schedule 2.7 to the Disclosure Memorandum as last updated by the Company prior to the Secondary Period Commencement Date , there shall not have occurred any Company Material Adverse Effect, and no event shall have occurred or circumstance shall exist that, in combination with any other events or circumstances, could reasonably be expected to have or result in a Company Material Adverse Effect.

 

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4.9 Agreements and Documents

Acquiror shall have received the following agreements and documents, each of which shall be in full force and effect:

(a) the Key Stockholder Agreements, executed by each of the Key Stockholders;

(b) the Noncompetition Agreements, executed by each of A. Bruce Montgomery, M.D. and William Baker, Ph.D;

(c) the General Releases, executed by the officers and directors of the Company and each of the Key Stockholders, as signed as of the date of this Agreement, and as re-signed as of the Closing Date;

(d) the Closing Payment Schedule;

(e) the FIRPTA Certificate, executed on behalf of the Company;

(f) a legal opinion of Orrick, Herrington & Sutcliffe LLP, counsel to the Company, dated as of the Closing Date and addressed to Acquiror and the Surviving Corporation, substantially in the form set forth as Exhibit B ;

(g) written resignations (provided pursuant to Section 1.6) of all officers and directors of the Company, effective as of the Effective Time; and

(h) the Countersigned Offer Letters.

 

4.10 Employee Retention

A. Bruce Montgomery, M.D., shall not have (a) ceased to be employed by, or expressed in writing to any Person (or orally to an officer or director of Acquiror or the Company which oral statement has not been retracted in writing) an intention to terminate employment with, the Company, (b) become incapable of fulfilling any of his material duties to the Company, or (c) expressed in writing to any Person (or orally to an officer or director of Acquiror or the Company which oral statement has not been retracted in writing) an intention to decline to accept, or an intention to terminate, employment with Acquiror, the Surviving Corporation or any other Subsidiary of Acquiror.

 

4.11 No Company Stock Rights

The Company shall have provided Acquiror with evidence, reasonably satisfactory to Acquiror, as to the exercise or termination of the Company Warrant and other Company Stock Rights (other than Company Stock Options).

 

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4.12 FIRPTA Compliance

The Company shall have provided written authorization for Acquiror to deliver the FIRPTA Certificate to the IRS on behalf of the Company upon the Closing.

 

4.13 Manufacture or Supply of Inhalation Devices

No adverse development event shall have occurred, and no adverse circumstance shall exist, that would reasonably be expected to have a significant impact on (i) the right or ability of PARI to manufacture either of the PARI Devices or to supply either of the PARI Devices to the Company or Acquiror, or (ii) the right or ability of PARI, the Company or Acquiror to deliver, or provide the delivery of, aztreonam through either of the PARI Devices.

 

4.14 Specified Litigation

(a) Unless the Litigation Resolution Date (as defined in Section 7.1(c) ) has occurred, no adverse development or event shall have occurred with respect to the Specified Litigation, and no adverse circumstance relating to the Specified Litigation shall exist or shall have been discovered by Acquiror, that would reasonably be expected to have a significant impact on the outcome of or the Company’s potential exposure in the Specified Litigation, on the nature or scope of any remedy to be awarded in the Specified Litigation, on the cost of defending the Specified Litigation, on the timing of the resolution of the Specified Litigation or on the prospects for settling the Specified Litigation.

(b) A final decision shall have been issued in any arbitration proceeding commenced for the purpose of determining the Lump Sum Equivalent Amount of any settlement entered into by the Company or Final Judgment entered by the court in connection with the Specified Litigation.

 

4.15 Secondary Period Election Notice

Acquiror shall have delivered a Secondary Period Election Notice to the Company.

ARTICLE V

CONDITIONS PRECEDENT TO OBLIGATIONS OF THE COMPANY

The obligations of the Company to effect the Merger and otherwise consummate the Contemplated Transactions shall be subject to the satisfaction at or prior to the Closing of the following conditions, which may be expressly waived only in a writing signed by the Company.

 

5.1 Accuracy of Representations and Warranties

Each of the representations and warranties of Acquiror and Merger Sub set forth in this Agreement (a) shall have been accurate in all material respects as of the Secondary Period Commencement Date as if made on and as of the Secondary Period Commencement Date, and (b) shall be accurate in all material respects as of the Closing Date as if made on and as of the Closing Date (except that any representation and warranty that is made exclusively as of, and that

 

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refers specifically to, a specified date need only have been accurate in all material respects as of such specified date); provided, however, that the condition set forth in this Section 5.1 shall be deemed to have been satisfied notwithstanding the existence of inaccuracies in such representations and warranties if the circumstances rendering such representations and warranties inaccurate have not had and could not reasonably be expected to have or result in a material adverse effect on Acquiror’s ability to consummate the Merger.

 

5.2 Performance of Agreements

Acquiror and Merger Sub shall have performed in all material respects each obligation and agreement, and complied with each covenant, contained in this Agreement or any other Operative Document to be performed or complied with by Acquiror or Merger Sub at or prior to the Closing.

 

5.3 Compliance Certificate

The Company shall have received a certificate of an officer of Acquiror, dated the Closing Date, in form and substance reasonably satisfactory to the Company, certifying, representing and warranting that the conditions set forth in Sections 5.1 and 5.2 have been duly satisfied.

 

5.4 Proceedings and Documents; Secretary’s Certificate

The Company shall have received a certificate of the Secretary of each of Acquiror and Merger Sub, in form and substance reasonably satisfactory to the Company, certifying, representing and warranting as to the authenticity and effectiveness of the actions of the Board of Directors of each of Acquiror and Merger Sub and of the sole stockholder of Merger Sub and the authorization by Acquiror and Merger Sub of the Merger and the Contemplated Transactions. Copies of the resolutions of the Board of Directors of each of Acquiror and Merger Sub, and the sole stockholder of Merger Sub, relating to the Contemplated Transactions shall be attached to such certificate.

 

5.5 Waiting Period

The waiting period applicable to the consummation of the Merger under the HSR Act shall have expired or been terminated.

 

5.6 Stockholder Approval

This Agreement shall have been duly adopted, and the Merger shall have been duly approved, by the Required Company Stockholder Vote.

 

5.7 Countersigned Offer Letters

The Company shall have received from Acquiror counterparts of the Countersigned Offer Letters signed on behalf of Acquiror.

 

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5.8 Specified Litigation

A final decision shall have been issued in any arbitration proceeding commenced for the purpose of determining the Lump Sum Equivalent Amount of any settlement entered into by the Company in connection with the Specified Litigation that is not a Lump Sum Settlement, or any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment.

 

5.9 Violation of Applicable Law or Order

The consummation by the Company of the Merger will not result in a violation of any U.S. federal or state Law in effect at the time of the Closing or any pending Order issued by a U.S. federal or state court of competent jurisdiction and binding on the Company, other than any such violation that would not result in the imposition of a material criminal or civil fine or penalty on the Stockholders.

 

5.10 Secondary Period Election Notice

Acquiror shall have delivered a Secondary Period Election Notice to the Company.

ARTICLE VI

COVENANTS

The Parties covenant and agree as set forth in this Article VI .

 

6.1 Conduct of Business by the Company During the Primary Period

Unless Acquiror shall otherwise agree in writing, during the Primary Period, the Company covenants and agrees to conduct the Company’s business in and only in, and the Company shall not take any action except in, the ordinary course of business and consistent with past practice and in accordance with applicable Law and the provisions of all Company Contracts, in each case in all material respects. Without limiting the generality of the foregoing, during the Primary Period, the Company (1) shall use commercially reasonable efforts consistent with past practice to preserve intact the business organization of the Company, to keep available the services of the current officers, employees and consultants of the Company and to preserve the current relationships of the Company with, and the goodwill of, suppliers, customers, development partners, landlords, creditors, licensors, licensees, key employees and other Persons with which the Company has significant business relations, (2) shall use commercially reasonable efforts to keep in full force all insurance policies referred to in Section 2.18 and, if any such insurance policy is scheduled to expire during the Primary Period, shall cause such insurance policy to be renewed or replaced (on terms and with coverage substantially equivalent to the terms and coverage of the expiring insurance policy) on or prior to the date of expiration of such insurance policy, and (3) shall as promptly as practicable notify Acquiror in writing of (A) any written notice or (to the knowledge of the Company) other communication from any Person alleging that the Consent of such Person is or may be required in connection with any of the Contemplated Transactions, and (B) any Legal Proceeding commenced, or, to the knowledge of the Company, threatened against, relating to or involving or otherwise affecting the Company or

 

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any of its products or Assets. By way of amplification and not limitation, the Company shall not, during the Primary Period, directly or indirectly do, or propose to do, any of the following without the prior written consent of Acquiror:

(a) amend or otherwise change the Company Certificate of Incorporation or Company Bylaws if such amendment or change would have, or could reasonably be expected to have, an adverse effect on Acquiror or the Company or on the Company’s ability to comply with any of its obligations under this Agreement or under any of the Operative Documents;

(b) except (A) for the issuance of shares of Company Capital Stock upon the exercise or conversion of Company Stock Options outstanding on the date of this Agreement or the Company Warrant, (B) for the issuance of shares of Company Capital Stock or equity securities (excluding any convertible debt securities) exercisable or convertible solely into shares of Company Capital Stock, or any combination of the foregoing, solely for cash to a Person who becomes a party to a Key Stockholder Agreement in favor of Acquiror contemporaneously with such issuance, (C) for the issuance of Eligible Debt Securities solely for cash to a Person who becomes a party to a Key Stockholder Agreement in favor of Acquiror contemporaneously with such issuance and (D) for the issuance of Company Stock Options with respect to shares of Company Common Stock (to the extent the reservation of such shares for issuance under the Company Option Plan has been approved by the Stockholders prior to the date of this Agreement), issue, sell, contract to issue or sell, pledge, dispose of, grant, encumber or authorize the issuance, sale, pledge, disposition, grant or Encumbrance of (i) any shares of Company Capital Stock, (ii) any Company Stock Option, (iii) the Company Warrant, (iv) any Company Stock Rights or (v) except in the ordinary course of business and consistent with past practice, any Assets of the Company;

(c) declare, set aside, make or pay any dividend or other distribution, payable in cash, stock or other securities, property or otherwise, with respect to any shares of Company Capital Stock or other securities, or redeem, purchase or otherwise acquire, directly or indirectly, any shares of Company Capital Stock or other securities (except for repurchases from individuals following their termination of service pursuant to the terms of their pre-existing stock option or purchase agreements);

(d) (i) acquire (including by merger, consolidation or acquisition of stock or Assets) any corporation, partnership or other Entity or business organization or division thereof or (except in the ordinary course of business and consistent with past practice) any material amount of Assets; (ii) except for the issuance of Eligible Debt Securities, incur any indebtedness for borrowed money (other than trade payables in the ordinary course of business or in connection with the transactions contemplated by this Agreement or the Specified Litigation) or issue any debt securities; (iii) assume, guarantee or endorse, or otherwise become responsible for, the obligations of any Person, or make any loans or advances (except that the Company may make routine travel advances to employees in the ordinary course of business and consistent with past practice not in excess of $10,000 in the aggregate); (iv) authorize any single capital expenditure not included in the Operating Budget that is in excess of $100,000 or capital expenditures not included in the Operating Budget that are, in the aggregate, in excess of $250,000; or (v) enter into any Contract not included in the Operating Budget in which the obligation of the Company exceeds $100,000 or which shall not terminate or be subject to termination for convenience without penalty within 30 days following execution;

 

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(e) (i) enter into or amend any material employment, consulting or agency Contract, hire any employee or engage any contractor except to the extent contemplated by and consistent with the Operating Budget, or hire any employee at the Vice President level or above (provided that the Company may hire a new Vice President – Clinical Development without the further consent of Acquiror), (ii) materially increase the wages, salary, bonus, commissions, fringe benefits or other compensation or remuneration payable or to become payable to, or grant any severance or termination pay to, or (except for annual salary increases to be made in the ordinary course of business and consistent with past practice that are reflected in the Operating Budget and except for bonuses described in Annex 6.2(e)) pay any bonus or make any discretionary profit-sharing or similar discretionary payment to, any Related Party, (iii) enter into any agreement or arrangement with any current or prospective Company Associate that provides for any of the types of payments or other benefits provided under the Change in Control Agreements, (iv) establish, adopt, enter into, amend or terminate any Employee Benefit Plan except as required by applicable Law, or (v) indemnify, or reimburse any expense of, any Related Party, in connection with the Specified Litigation or otherwise, except to the extent legally or contractually required pursuant to the Company Certificate of Incorporation, the Company Bylaws or any individual agreements identified in Annex 6.2(e) as in effect on the date of this Agreement;

(f) except as provided in the Countersigned Offer Letters, (i) amend any Change in Control Agreement in any manner favorable to the employee of the Company who is a party to such Change in Control Agreement in respect of the Contemplated Transactions, or (ii) amend or waive any of its rights under, or exercise discretion to accelerate the vesting under, any provision of the Company Option Plan, any provision of any Contract evidencing any outstanding Company Stock Option or any restricted stock purchase agreement, or otherwise modify any of the terms of any outstanding Company Stock Option, the Company Warrant or any other security or any related Contract, or fail to exercise any repurchase right with respect to any shares of Company Capital Stock (unless Acquiror consents in writing to the Company failing to exercise any such repurchase right);

(g) pay, discharge or satisfy any Liability to or for the benefit of any Related Party, other than the payment, discharge or satisfaction of Liabilities (i) incurred in the ordinary course of business and consistent with past practice, (ii) required to be incurred in connection with the transactions contemplated by this Agreement or (iii) incurred in connection with the Specified Litigation;

(h) purchase, dispose of, license, relinquish or otherwise give up any right with respect to any material Intellectual Property or Intellectual Property Right;

(i) amend or terminate, or waive or exercise any material right or remedy under, any Material Contract;

 

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(j) commence or settle any Legal Proceeding (except that the Company may settle the Specified Litigation if (i) such settlement is a Lump Sum Settlement or (ii) Acquiror and the Company have agreed as to the Lump Sum Equivalent Amount of such settlement);

(k) make any expenditure with respect to any item included in any of the “Major Categories” of the operating budget of the Company attached as Annex 6.1(k) (subject to Section 6.5(d) , the “ Operating Budget ”) that causes the total expenditures made by the Company with respect to such Major Category to exceed 110% of the amount budgeted for such Major Category in the Operating Budget for any fiscal quarter;

(l) take or fail to take, or permit or fail to permit the taking of, any action with the intent of reducing the value of this Agreement to Acquiror, or take or knowingly fail to take, or knowingly permit or knowingly fail to permit the taking of, any action that could reasonably be expected to have the effect of reducing in any material respect the value of this Agreement to Acquiror; or

(m) agree or commit to do any of the foregoing.

 

6.2 Conduct of Business by the Company During the Secondary Period

Unless Acquiror shall otherwise agree in writing, during the Secondary Period, the Company covenants and agrees to conduct the Company’s business in and only in, and the Company shall not take any action except in, the ordinary course of business and consistent with past practice and in accordance with applicable Law and the provisions of all Company Contracts, in each case in all material respects. Without limiting the generality of the foregoing, during the Secondary Period, the Company (1) shall use commercially reasonable efforts consistent with past practice to preserve intact the business organization of the Company, to keep available the services of the current officers, employees and consultants of the Company and to preserve the current relationships of the Company with, and the goodwill of, suppliers, customers, development partners, landlords, creditors, licensors, licensees, key employees and other Persons with which the Company has significant business relations, (2) shall use commercially reasonable efforts to keep in full force all insurance policies referred to in Section 2.18 and, if any such insurance policy is scheduled to expire during the Secondary Period, shall cause such insurance policy to be renewed or replaced (on terms and with coverage substantially equivalent to the terms and coverage of the expiring insurance policy) on or prior to the date of expiration of such insurance policy, (3) shall as promptly as practicable notify Acquiror in writing of (A) any written notice or (to the knowledge of the Company) other communication from any Person alleging that the Consent of such Person is or may be required in connection with any of the Contemplated Transactions, and (B) any Legal Proceeding commenced, or, to the knowledge of the Company, threatened against, relating to or involving or otherwise affecting the Company or any of its products or Assets, (4) shall cause its officers to report to Acquiror with reasonable frequency concerning the status of the business of the Company and (5) shall perform and comply with all of its covenants, agreements and obligations in the other Operative Documents. By way of amplification and not limitation, the Company shall not, during the Secondary Period, directly or indirectly do, or propose to do, any of the following without the prior written consent of Acquiror:

 

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(a) amend or otherwise change the Company Certificate of Incorporation or Company Bylaws if such amendment or change would have, or could reasonably be expected to have, an adverse effect on Acquiror or the Company or on the Company’s ability to comply with any of its obligations under this Agreement or under any of the other Operative Documents;

(b) except (A) for the issuance of shares of Company Capital Stock upon the exercise or conversion of Company Stock Options outstanding on the date of this Agreement or the Company Warrant, (B) for the issuance of shares of Company Capital Stock or equity securities (excluding any convertible debt securities) exercisable or convertible solely into shares of Company Capital Stock, or any combination of the foregoing, solely for cash to a Person who becomes a party to a Key Stockholder Agreement in favor of Acquiror contemporaneously with such issuance, (C) for the issuance of Eligible Debt Securities solely for cash to a Person who becomes a party to a Key Stockholder Agreement in favor of Acquiror contemporaneously with such issuance and (D) for the issuance of Company Stock Options with respect to shares of Company Common Stock (to the extent the reservation of such shares for issuance under the Company Option Plan has been approved by the Stockholders prior to the date of this Agreement), issue, sell, contract to issue or sell, pledge, dispose of, grant, encumber or authorize the issuance, sale, pledge, disposition, grant or Encumbrance of (i) any shares of Company Capital Stock, (ii) any Company Stock Option, (iii) the Company Warrant, (iv) any Company Stock Rights or (v) except in the ordinary course of business and consistent with past practice, any Assets of the Company;

(c) declare, set aside, make or pay any dividend or other distribution, payable in cash, stock or other securities, property or otherwise, with respect to any shares of Company Capital Stock or other securities, or redeem, purchase or otherwise acquire, directly or indirectly, any shares of Company Capital Stock or other securities (except for repurchases from individuals following their termination of service pursuant to the terms of their pre-existing stock option or purchase agreements);

(d) (i) acquire (including by merger, consolidation or acquisition of stock or Assets) any corporation, partnership or other Entity or business organization or division thereof or (except in the ordinary course of business and consistent with past practice) any material amount of Assets; (ii) except for the issuance of Eligible Debt Securities, incur any indebtedness for borrowed money (other than trade payables in the ordinary course of business or in connection with the transactions contemplated by this Agreement or the Specified Litigation) or issue any debt securities; (iii) assume, guarantee or endorse, or otherwise become responsible for, the obligations of any Person, or make any loans or advances (except that the Company may make routine travel advances to employees in the ordinary course of business and consistent with past practice not in excess of $10,000 in the aggregate); (iv) authorize any single capital expenditure not included in the Operating Budget that is in excess of $100,000 or capital expenditures not included in the Operating Budget that are, in the aggregate, in excess of $250,000; or (v) enter into any Contract in which the obligation of the Company exceeds $100,000 or which shall not terminate or be subject to termination for convenience without penalty within 30 days following execution;

 

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(e) (i) enter into or amend any material employment, consulting or agency Contract, hire any employee or engage any contractor except in order to fill a position vacated after the date of this Agreement, promote any employee except in order to fill a position vacated after the date of this Agreement or hire any employee at the Vice President level or above, (ii) materially increase the wages, salary, bonus, commissions, fringe benefits or other compensation or remuneration payable or to become payable to any Company Associates, (iii) grant any severance or termination pay to, or enter into any employment or severance arrangement with, any Person who is a director or officer of the Company, (iv) enter into any agreement or arrangement with any current or prospective Company Associate that provides for any of the types of payments or other benefits provided under the Change in Control Agreements, (v) except for bonuses described in Annex 6.2(e) , pay any bonus or make any discretionary profit-sharing or similar discretionary payment, or (vi) establish, adopt, enter into, amend or terminate any Employee Benefit Plan except as required by applicable Law;

(f) amend any Change in Control Agreement in any manner favorable to the employee of the Company who is a party to such Change in Control Agreement in respect of the Contemplated Transactions, or amend or waive any of its rights under, or exercise discretion to accelerate the vesting under, any provision of the Company Option Plan, any provision of any Contract evidencing any outstanding Company Stock Option or any restricted stock purchase agreement, or otherwise modify any of the terms of any outstanding Company Stock Option, the Company Warrant or any other security or any related Contract, or fail to exercise any repurchase right with respect to any shares of Company Capital Stock (unless Acquiror consents in writing to the Company failing to exercise any such repurchase right);

(g) take any action, other than reasonable and usual actions in the ordinary course of business and consistent with past practice, with respect to accounting methods, policies or procedures (including procedures with respect to the payment of accounts payable and collection of accounts receivable);

(h) incur any Tax Liability other than in the normal course of business, or make any material Tax election or settle or compromise any Tax Liability;

(i) pay, discharge or satisfy any Liability, other than the payment, discharge or satisfaction of Liabilities (i) incurred in the ordinary course of business and consistent with past practice, (ii) required to be incurred in connection with the transactions contemplated by this Agreement or (iii) incurred in connection with the Specified Litigation;

(j) take or fail to take any action that could reasonably be expected to result in any of the representations or warranties of the Company set forth in this Agreement or any of the other Operative Documents being untrue in any material respect, or in any obligation, agreement or covenant of the Company set forth in this Agreement or any of the other Operative Documents being breached, or in any of the conditions to the Merger specified in Articles IV and V not being satisfied;

(k) form any Subsidiary or acquire any equity interest or other interest in any other Entity;

 

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(l) purchase, dispose of, license, relinquish or otherwise give up any right with respect to any material Intellectual Property or Intellectual Property Right;

(m) enter into or become bound by, or permit any of the Assets owned or used by it to become bound by, any Material Contract, or amend or terminate, or waive or exercise any material right or remedy under, any Material Contract;

(n) make any discretionary filing or fail to make any required material filing with any Governmental Entity;

(o) change in any material respect any of its personnel policies or other business policies, or any of its methods of accounting or accounting practices in any respect;

(p) enter into or amend any lease, sublease, rental agreement, contract of sale, tenancy, license or other Contract relating to any real property;

(q) voluntarily file any petition under the United States Bankruptcy Code or make any similar filing or commence any proceeding under any state Law respecting insolvency, or cooperate in any way with or fail to vigorously opposed any such petition, filing or proceeding made, filed or commenced by any third party;

(r) commence or settle any Legal Proceeding (except that the Company may settle the Specified Litigation if (i) such settlement is a Lump Sum Settlement or (ii) Acquiror and the Company have agreed as to the Lump Sum Equivalent Amount of such settlement);

(s) indemnify, or reimburse any expense of, any Company Associate or agent, in connection with the Specified Litigation or otherwise, except to the extent legally or contractually required pursuant to the Company Certificate of Incorporation, the Company Bylaws or any individual agreements identified in Annex 6.13(a) as in effect on the date of this Agreement;

(t) make any expenditure with respect to any item included in any of the “Major Categories” of the Operating Budget that causes the total expenditures made by the Company with respect to such Major Category to exceed 110% of the amount budgeted for such Major Category in the Operating Budget for any fiscal quarter; or

(u) agree or commit to do any of the foregoing.

 

6.3 Certain Actions with Respect to Specified Litigation

(a) During the Pre-Closing Period:

(i) the Company (A) shall use its commercially reasonable efforts to expeditiously obtain a Final Judgment in the Specified Litigation, provided, however , that, subject to Section 6.1(j) , the Company, after consideration of input from Acquiror, shall retain the right to determine, in its sole discretion, whether to enter into any pre-trial or post-trial settlement with respect to the Specified Litigation, (B) shall not request, agree to or (to the extent

 

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the Company has the ability to do so) otherwise permit any continuance of or delay in the trial date (except to the extent needed to accommodate lead trial counsel’s conflicting trial obligation to the extent disclosed by the Company to Acquiror prior to the date of this Agreement), the post-trial motion schedule or the appeal schedule for the Specified Litigation without Acquiror’s prior written consent, and (C) shall keep Acquiror apprised of all significant developments in the Specified Litigation substantially to the same extent and in the same manner as Company’s litigation counsel keeps the Company’s management informed of such developments;

(ii) Acquiror and its Representatives shall be entitled to participate in (to the extent allowed under the governing protective order), and the Company shall cause Acquiror to receive advance notice (immediately after any notice is given to the Company) of, all settlement discussions, settlement negotiations and other settlement proceedings with respect to the Specified Litigation;

(iii) the Company shall invite a Representative of Acquiror designated by Acquiror (“ Designated Representative ”) to attend (A) all formal and informal meetings of the Litigation Committee of its Board of Directors and (B) any other meetings between Representatives of the Company and its legal advisors where matters material to the Specified Litigation are expected to be discussed;

(iv) the Company shall give the Designated Representative copies of all written notices, written memoranda, written updates, written communications and other written materials provided to any member of the Litigation Committee and shall update the Designated Representative, as promptly as practicable, regarding any information provided to any member of the Litigation Committee with respect to the Specified Litigation by telephone, email or other non-written means;

(v) Acquiror shall have the right to consult with the Company’s counsel for the Specified Litigation on a regular basis and the Company shall arrange for such consultations to occur; and

(vi) subject to Section 6.3(d) , the Company shall promptly provide to Acquiror any materials related to the Specified Litigation that Acquiror reasonably requests.

(b) During the Pre-Closing Period, the Company shall promptly (and in any event, within one (1) Business Day after the generation or receipt thereof by the Company) provide to Acquiror copies of (or in the case of oral proposals or communications, oral or written summaries, whichever is more expedient of) all significant pleadings, all significant filings, all settlement proposals and other settlement communications served or made in connection with the Specified Litigation by any party or entity, and all work product of outside counsel that is shared with the Company.

(c) In the event that, during the Pre-Closing Period, a settlement is entered into in connection with the Specified Litigation that is not a Lump Sum Settlement or a Final Judgment is entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment, the Parties shall attempt in good faith to reach agreement on the “Lump Sum

 

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Equivalent Amount” of such settlement or Final Judgment as expeditiously as possible. If the parties are unable to reach agreement on the Lump Sum Equivalent Amount of such settlement or Final Judgment within three Business Days after the entering into of such settlement or the entry of such Final Judgment, then either Party may require that the Lump Sum Equivalent Amount of such settlement or Final Judgment be determined by arbitration in accordance with the principles and procedures set forth on Annex 6.3(c) , and the Parties shall use commercially reasonable efforts to cause such arbitration to be completed within thirty (30) days after the date on which such determination has been submitted to arbitration.

(d) Notwithstanding anything to the contrary in this Section 6.3 , the Company shall not be required to take any action or to disclose to Acquiror any information to the extent the Company reasonably determines, after consultation with its litigation counsel, that such action or disclosure would result in a violation of any Law or Order applicable to the Company.

 

6.4 Further Action; Commercially Reasonable Efforts

(a) Upon the terms and subject to the conditions hereof, except as set forth in Section 6.4(c) , during the Secondary Period, each of the Parties shall use commercially reasonable efforts to take, or cause to be taken, all appropriate action, and to do, or cause to be done, all things necessary, proper or advisable under applicable Laws to consummate the Merger and otherwise make effective the Contemplated Transactions, including using commercially reasonable efforts to obtain all Governmental Authorizations (including under the HSR Act) needed to be obtained by such Party for the consummation of the Contemplated Transactions and to satisfy the conditions to the other Party’s obligation to consummate the Merger.

(b) Without limiting the foregoing, but subject to Section 6.4(c) , each Party shall use commercially reasonable efforts to file, as soon as practicable after the commencement of the Secondary Period, all notices, reports and other documents required to be filed by such Party with any Governmental Entity with respect to the Merger and the other Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Entity. Without limiting the generality of the foregoing, but subject to Section 6.4(c) , during the Secondary Period (i) each of the Company, Acquiror and Merger Sub shall use its commercially reasonable efforts to make promptly any required submissions under the HSR Act and any other applicable state, federal or foreign antitrust or competition Laws (collectively, the “ Antitrust Laws ”) in connection with the Merger and the Contemplated Transactions, and (ii) Acquiror, Merger Sub and the Company shall cooperate with one another (A) in promptly determining whether any filings are required to be or should be made or consents, approvals, permits or authorizations are required to be or should be obtained under any other federal, state or foreign Law or regulation or whether any Consents are required to be or should be obtained from other parties to Company Contracts in connection with the consummation of the Contemplated Transactions and (B) in promptly making any such filings, furnishing information required in connection therewith and seeking to obtain timely any such Consents. In addition, if, during the Primary Period, Acquiror determines, in its sole discretion, to file a premerger notification and report form under the HSR Act with respect to the Contemplated Transactions, then the Company shall file, as promptly as practicable, a premerger notification and report form under the HSR Act with respect to the Contemplated Transactions. Subject to Section 6.4(c) ,

 

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during the Secondary Period the Company and Acquiror shall (x) respond as promptly as practicable to (1) any inquiries or requests received from the Federal Trade Commission or the Department of Justice for additional information or documentation, and (2) any inquiries or requests received from any state attorney general, foreign antitrust authority or other Governmental Entity in connection with antitrust or related matters, (y) use commercially reasonable efforts to take all other actions necessary to cause the expiration or termination of the applicable waiting periods under the Antitrust Laws as soon as practicable, and (z) use commercially reasonable efforts to resolve any objections which may be asserted by any Governmental Entity with respect to the Merger under the Antitrust Laws. Acquiror and the Company shall cooperate with respect to any proceedings or negotiations with any Governmental Entity relating to any of the foregoing. At the request of Acquiror, during the Secondary Period the Company shall use commercially reasonable efforts to divest, sell, dispose of, hold separate or otherwise take or commit to take any reasonable action relating to the business, product lines or Assets of the Company, provided that any such action is (I) determined by Acquiror in good faith to facilitate compliance with any Law or any request by any Governmental Entity, and (II) conditioned upon the consummation of the Merger.

(c) Notwithstanding anything to the contrary contained in this Agreement, Acquiror shall not have any obligation, directly or indirectly, whether under this Agreement or otherwise: (i) to dispose of or transfer (or cause the Surviving Corporation to dispose of or transfer) any Assets, or to commit to (or commit to cause the Surviving Corporation to) dispose of or transfer any Assets; (ii) to discontinue offering any product or service, or to commit to (or commit to cause the Surviving Corporation to) discontinue offering any product or service; (iii) to license or otherwise make available to any Person any technology, software or other Intellectual Property or Intellectual Property Right, or to commit to (or commit to cause the Surviving Corporation to) license or otherwise make available to any Person any technology, software or other Intellectual Property or Intellectual Property Right; (iv) to hold separate any Assets or operations (either before or after the Closing Date), or to commit to (or commit to cause the Surviving Corporation to) hold separate any Assets or operations; (v) to make any commitment (to any Governmental Entity or otherwise) regarding its future operations or the future operations of the Surviving Corporation; (vi) to contest any Legal Proceeding relating to the Merger if Acquiror determines in good faith that contesting such Legal Proceeding is not advisable; or (vii) to guarantee to any third party the performance by the Surviving Corporation of any Company Contracts or any obligations or Liabilities of the Company.

(d) During the Secondary Period, (a) the Company shall use commercially reasonable efforts to cause the conditions set forth in Article IV to be satisfied on a timely basis, and (b) subject to Section 6.4(c) , Acquiror and Merger Sub shall use commercially reasonable efforts to cause the conditions set forth in Article V to be satisfied on a timely basis.

(e) During the Pre-Closing Period, the Company shall use commercially reasonable efforts to obtain an executed assignment from Teva, in form and substance reasonably acceptable to Acquiror, transferring to the Company all rights held by Teva in U.S. Patent Application Serial Number 10/882,591 and its foreign counterparts, as well as additional executed assignments to the extent necessary or appropriate to transfer ownership in the foreign counterparts associated with the subject U.S. patent application.

 

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6.5 Access to Information

(a) During the Pre-Closing Period, the Company shall afford Acquiror and its Representatives reasonable access during normal business hours to (i) all of the Company’s properties, books, Contracts, work papers, commitments and records and all of the documents, records and work papers of the Company’s Representatives relating to the Company or any of the Contemplated Transactions, and (ii) all other information concerning the business, properties and personnel of the Company as Acquiror may reasonably request that is within the control of the Company or its Representatives, and shall provide Acquiror and Acquiror’s Representatives with copies of such existing books, records, Tax Returns, work papers, Company Contracts and other documents and information relating to the Company, and with such additional financial, operating and other data and information regarding the Company, as Acquiror may reasonably request.

(b) During the Pre-Closing Period, the Company shall cause its Representatives to confer on a regular and frequent basis with one or more Representatives of Acquiror to report material operational matters and the general status of ongoing operations.

(c) Within 20 days after the end of each calendar month during the Pre-Closing Period, the Company shall deliver to Acquiror (i) a balance sheet of the Company as of the last day of such calendar month, (ii) a statement of operations for such calendar month and for the period from January 1, 2006 through the end of such calendar month, (iii) a statement of cash flows for such calendar month and for the period from January 1, 2006 through the end of such calendar month, (iv) a statement comparing actual expenses during such calendar month (by “Major Category”) against one-third (  1 / 3 ) of the respective amounts set forth with respect to such items in the Operating Budget with respect to the calendar quarter that includes such calendar month, and (v) a statement comparing the actual cash balance at the end of such calendar month against either (A) if such month is the last month of a calendar quarter, the applicable amount set forth in the Operating Budget as the “Quarter ending cash balance” as of the last day of such calendar quarter, or (B) if such month is not the last month of a calendar quarter, an amount determined by interpolating, on a straight-line basis, between (i) the amount set forth in the Operating Budget as the “Quarter ending cash balance” as of the last day of the calendar quarter that immediately precedes the calendar quarter that includes such calendar month, and (ii) the amount set forth in the Operating Budget as the “Quarter ending cash balance” as of the last day of the calendar quarter that includes such calendar month.

(d) By not later than November 15, 2006 (if the Closing has not occurred by such date), the Company shall develop and deliver to Acquiror an update to the Operating Budget covering calendar year 2007 (the “ 2007 Budget ”), which shall as to form be identical in all material respects to the form of the Operating Budget attached as Annex 6.1(k) . The 2007 Budget shall be subject to the written approval of Acquiror, such approval not to be unreasonably withheld. The 2007 Budget, as finally developed by the Company and approved by Acquiror, shall from and after January 1, 2007 be considered for all purposes hereunder (with respect to the operations of the Company during 2007) the “Operating Budget” as that term is used in this Agreement.

 

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(e) During the Pre-Closing Period, the Company shall promptly provide to Acquiror (i) any material notice, report, correspondence, action, document or other communication received by the Company or (to the knowledge of the Company) PARI or Euticals from, or sent on behalf of the Company or (to the knowledge of the Company) PARI or Euticals to, the FDA, the EMEA or any similar state or foreign Governmental Entity relating to the clinical or regulatory status of the Company 1020 Product or (ii) any material notice, report or other document received by the Company from, or sent on behalf of the Company to, any other Governmental Entity.

 

6.6 Development of Company 1020 Product

During the Pre-Closing Period, the Company shall use diligent efforts to develop the Company 1020 Product (including completion of two Phase 3 studies (005 and 007) including data lock and study report, and completion of the preclinical and CMC sections of the NDA submission.

 

6.7 Confidentiality

The Parties acknowledge that Acquiror and the Company have previously entered into a Non-Disclosure Agreement dated as of April 26, 2005 and entered into on behalf of Acquiror on June 17, 2005 (the “ Non-Disclosure Agreement ”), which shall continue in full force and effect in accordance with its terms. In addition, the Parties agree that the terms and conditions of the Contemplated Transactions, and the information exchanged in connection with the execution and performance hereof and pursuant to Section 6.5 , shall (to the extent it constitutes “Confidential Information” under the Non-Disclosure Agreement) be subject to the same standard of confidentiality as set forth in the Non-Disclosure Agreement. The parties further agree that, for purposes of Section 7 of the Non-Disclosure Agreement, the term of Acquiror’s obligations under such section shall run until the earlier of (i) the Closing Date and (ii) the first anniversary of the termination of this Agreement.

 

6.8 Public Disclosure

During the Pre-Closing Period, Acquiror and the Company shall consult with each other before issuing any press release or otherwise making any public disclosure (whether or not in response to an inquiry) regarding the terms of this Agreement and the Contemplated Transactions. Except as may be required by applicable Law, the Company shall not, without the prior written approval of Acquiror, make any such statement or disclosure regarding this Agreement or any of the Contemplated Transactions.

 

6.9 Notification of Certain Matters

(a) During the Pre-Closing Period, the Company shall give prompt written notice to Acquiror of (i) the occurrence or nonoccurrence of any event, condition, fact or circumstance that could reasonably be expected to cause any representation or warranty made by the Company contained in this Agreement or in any of the other Operative Documents to be untrue or inaccurate in any material respect (provided that such notice shall be required to be

 

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made with respect to any representation or warranty that is made exclusively as of, and that refers specifically to, a specified date only if any event, condition, fact or circumstance results in or evidences the untruth or inaccuracy of such representation or warranty as of such specified date), (ii) any failure by the Company to comply with or satisfy any obligation, agreement or covenant to be complied with or satisfied by it hereunder, (iii) any pending or, to the knowledge of the Company, threatened Legal Proceeding by any Governmental Entity or any other Person (A) concerning any of the Contemplated Transactions, (B) challenging or seeking material damages in connection with this Agreement or any of the Contemplated Transactions, or (C) seeking to restrain or prohibit the consummation of the Merger or any of the Contemplated Transactions or otherwise limit the right of Acquiror or its Subsidiaries to own or operate all or any portion of the businesses or Assets of the Company, and (iv) any event, condition, fact or circumstance that would make the timely satisfaction of any of the conditions set forth in Article IV impossible or unlikely or that has had or could reasonably be expected to have or result in a Company Material Adverse Effect.

(b) At any time during the Primary Period, but not more frequently than once in each calendar month, Acquiror may deliver to the Company a written notice in the form attached hereto as Exhibit C (a “ Disclosure Memorandum Update Request ”) stating that Acquiror is considering delivering a Secondary Period Election Notice, and requesting that the Company deliver to Acquiror an update to the Disclosure Memorandum (a “ Disclosure Memorandum Update ”). For purposes of any Disclosure Memorandum Update: (a) the term “as of the date of this Agreement” as used throughout Article 2 shall be deemed to refer to the date on which such Disclosure Memorandum Update is delivered by the Company to Acquiror; and (b) the term “Balance Sheet Date” as used in Section 2.6 shall be deemed to refer to the last day of the most recent fiscal quarter of the Company for which financial statements of the Company are available prior to the date on which such Disclosure Memorandum Update is delivered by the Company to Acquiror. As soon as practicable following its receipt of a Disclosure Memorandum Update Request, and in any event within ten (10) Business Days after Acquiror delivers a Disclosure Memorandum Update Request to the Company, the Company shall deliver to Acquiror an accurate and complete Disclosure Memorandum Update. Except as otherwise expressly provided herein, no Disclosure Memorandum Update, and no matter disclosed pursuant to Section 6.9(a) , shall be deemed to supplement or amend the Disclosure Memorandum for the purpose of, or otherwise be taken into account in, (i) determining the accuracy of any of the representations and warranties made by the Company in this Agreement or in any other Operative Document, (ii) determining whether the Company has complied with its obligations, agreements and covenants under this Agreement or any other Operative Document or (iii) determining whether any condition set forth in Article IV has been satisfied.

(c) During the Pre-Closing Period, Acquiror shall give prompt written notice to the Company of (i) any pending or, to the knowledge of Acquiror, threatened Legal Proceeding by any Governmental Entity or any other Person (A) concerning any of the Contemplated Transactions, (B) challenging or seeking material damages in connection with this Agreement or any of the Contemplated Transactions, or (C) seeking to restrain or prohibit the consummation of the Merger or any of the Contemplated Transactions or otherwise limit the right of Acquiror or its Subsidiaries to own or operate all or any portion of the businesses or Assets of the Company, and (ii) any event, condition, fact or circumstance that would make the timely satisfaction of any

 

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of the conditions set forth in Article V of the Merger Agreement impossible or unlikely. In addition, during the Secondary Period, Acquiror shall give prompt written notice to the Company of (x) the occurrence or nonoccurrence of any event, condition, fact or circumstance that could reasonably be expected to cause any representation or warranty made by Acquiror contained in this Agreement to be untrue or inaccurate in any material respect (provided that such notice shall be required to be made with respect to any representation or warranty that is made exclusively as of, and that refers specifically to, a specified date only if any event, condition, fact or circumstance results in or evidences the untruth or inaccuracy of such representation or warranty as of such specified date), and (y) any failure by Acquiror to comply with or satisfy any obligation, agreement or covenant to be complied with or satisfied by it hereunder.

 

6.10 No Specified Transactions

Unless this Agreement shall have been terminated in accordance with its terms, the Company shall not, directly or indirectly, during the Pre-Closing Period, through any Representative or otherwise, (a) solicit, initiate, knowingly encourage or knowingly facilitate the submission of any proposal or offer from any Person relating to any Specified Transaction, (b) participate in any negotiations or discussions or enter into any Contract with any Person (other than Acquiror) relating to any Specified Transaction or any proposal or offer relating to any Specified Transaction, (c) furnish to any Person (other than Acquiror) any information (relating to the Company, the Specified Litigation or otherwise) in connection with any Specified Transaction or any proposal or offer relating to any Specified Transaction, (d) cooperate in any way with any Person (other than Acquiror) in connection with any Specified Transaction or any proposal or offer relating to any Specified Transaction, (e) assist or participate in, knowingly facilitate or knowingly encourage, consider, entertain or accept any proposal or offer from any Person (other than Acquiror) relating to any Specified Transaction or any effort or attempt by any Person (other than Acquiror) to make any such proposal or offer relating to any Specified Transaction or (f) effect or become a party to any Specified Transaction. The Company shall notify Acquiror in writing promptly if any such proposal or offer, or any inquiry or contact with any Person with respect thereto, is made and shall, in any such notice to Acquiror, indicate in reasonable detail the identity of the Person making such proposal, offer, inquiry or contact and the terms and conditions of such proposal, offer, inquiry or contact. The Company agrees not to release any third party from, or waive any provision of, any confidentiality or standstill agreement to which the Company is a party or under which the Company has any rights. Within ten (10) Business Days after the date of this Agreement, the Company shall demand (and the Company shall thereafter use commercially reasonable efforts to obtain) the return of all confidential information provided to any prospective acquirer of the Company or any other Person at any time since January 1, 2005, except that to the extent expressly permitted by the terms of any existing nondisclosure agreement between the Company and any such prospective acquirer, counsel to such prospective acquirer may be entitled to retain an archival copy of such confidential information (subject to the continuing effect of such nondisclosure agreement).

 

6.11 Stockholder Consent

Immediately following the execution of this Agreement, each Key Stockholder is executing and delivering to the Company and Acquiror a written consent adopting this

 

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Agreement and approving the Merger and approving certain other matters relating to the Contemplated Transactions (the “ Stockholder Consent ”). The Company shall not cause or permit any Key Stockholder to withdraw such Key Stockholder’s adoption of this Agreement or approval of the Merger or approval of the other matters set forth therein as evidenced by the Stockholder Consent, or take any other action that is inconsistent with such Stockholder Consent or that may have the effect of delaying or interfering with the Merger. As promptly as practicable following the date of this Agreement, the Company shall prepare an information statement accurately and completely describing this Agreement, the Merger, the other Contemplated Transactions and the provisions of Section 262 of the DGCL (the “ Information Statement ”), and shall (following the review and approval of the Information Statement by Acquiror and its counsel) deliver the Information Statement to those of its Stockholders who did not execute Stockholder Consents for the purpose of informing them of the adoption of this Agreement and approval of the Merger and soliciting either (a) their execution of the Stockholder Consent, or (b) their waiver of their appraisal rights pursuant to Section 262 of the DGCL. The Information Statement shall include a statement to the effect that the Company’s Board of Directors unanimously recommends that the Stockholders execute the Stockholder Consent adopting this Agreement and approving the Merger, and that the Stockholders waive their appraisal rights pursuant to Section 262 of the DGCL, and the Company’s Board of Directors shall not withdraw or adversely modify (or propose to withdraw or adversely modify) such recommendation unless required to do so by their fiduciary duties under the DGCL.

 

6.12 Dissenting Shares

Without limiting the obligations of the Company pursuant to Section 1.7.2(c) , not later than two Business Days prior to the Closing Date, the Company shall furnish Acquiror with the name and address of any Stockholder who, prior to the Closing, has requested appraisal rights pursuant to Section 262 of the DGCL (and who is thus a Dissenting Holder), and the number of Dissenting Shares owned by such Dissenting Holder.

 

6.13 Indemnification of Officers and Directors

(a) Subject to the terms of the General Releases, Acquiror agrees that all rights to indemnification for acts or omissions occurring prior to the Effective Time existing as of the date of this Agreement in favor of the current directors and officers of the Company as provided in the Company Certificate of Incorporation, the Company Bylaws or any individual agreements identified in Annex 6.13(a) shall survive the Merger and shall continue in full force and effect in accordance with their terms for six years following the Effective Time, and Acquiror shall cause the Surviving Corporation to fulfill and honor such obligations to the maximum extent permitted by, and subject to all limitations contained in, applicable Laws. This Section 6.13 shall survive the consummation of the Merger and is intended to be for the benefit of, and shall be enforceable by, all individuals who are officers and directors of the Company as of the date of this Agreement, and shall be binding upon Acquiror and the Surviving Corporation.

(b) For a period of six years after the Effective Time, Acquiror shall maintain in effect, for actions that shall have been taken prior to the Effective Time by the Company’s

 

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current officers and directors in their capacities as such, the existing level and scope of directors’ and officers’ liability insurance covering those current directors and officers of the Company who are covered by the Company’s existing directors’ and officers’ liability insurance policy as of the date of this Agreement, to the extent that directors’ and officers’ liability insurance coverage is commercially available; provided, however , that, in satisfying its obligations under this Section 6.13 , Acquiror shall not be obligated to pay premiums in excess of $80,000 per annum.

 

6.14 Company Warrant

The Company shall ensure that the Company Warrant (if not exercised as of the Effective Time) is terminated as of the Effective Time; provided, however , that the Company Warrant shall be deemed to have been exercised on a net exercise basis, as if fully vested and exercisable, immediately prior to the Closing and the shares of Company Common Stock deemed issued with respect to the Company Warrant shall be converted at the Effective Time into the right to receive consideration pursuant to Section 1.7.1(e) ; provided further , that any such consideration payable to the holder of the Company Warrant shall be subject to applicable Tax withholding.

 

6.15 Employee Benefits Matters

(a) Acquiror agrees that each employee of the Company who continues employment with Acquiror or the Surviving Corporation after the Effective Time (a “ Continuing Employee ”) shall, subject to any applicable plan provisions, contractual requirements, insurance policy terms and applicable Laws, (i) be eligible to participate in Acquiror’s health, vacation, severance and 401(k) plans, to substantially the same extent as similarly situated employees of Acquiror, and (ii) receive credit under such plans for such Continuing Employee’s consecutive partial or full years of service with the Company prior to the Effective Time for purposes of determining such Continuing Employee’s eligibility to participate in such plans (but not for purposes of any accruals under any such plans).

(b) Notwithstanding anything in this Agreement to the contrary, nothing in this Agreement shall obligate Acquiror to make or cause to be made an offer of continuing employment to any particular employee of the Company. The employment by Acquiror or the Surviving Corporation of all Continuing Employees shall be solely on at “at-will” basis. No Continuing Employee, and no other Company Associate, shall be deemed to be a third party beneficiary of this Agreement.

(c) Notwithstanding anything in this Agreement to the contrary, from and after the Effective Time, Acquiror and the Surviving Corporation shall have sole discretion over the hiring, promotion, retention, firing and other terms and conditions of the employment of employees of the Surviving Corporation. Except as otherwise provided in this Section 6.15 , nothing in this Agreement shall prevent Acquiror and the Surviving Corporation from amending or terminating any Company Benefit Plan or any benefit plan of Acquiror, in each case, to the extent permitted by its terms.

(d) With respect to any welfare plan maintained by Acquiror in which employees of the Company are eligible to participate after the Effective Time, Acquiror shall,

 

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subject to any applicable plan provisions, contractual requirements, insurance policy terms and applicable Laws, waive all limitations as to preexisting conditions and exclusions with respect to participation and coverage requirements applicable to such employees to the extent such conditions and exclusions were satisfied or did not apply to such employees under the welfare plans maintained by the Company or its Affiliates prior to the Effective Time.

 

6.16 FIRPTA Matters

At the Closing, the Company shall deliver to Acquiror a statement (in such form as may be requested by counsel to Acquiror ) conforming to the requirements of Section 1.897-2(h)(1)(i) of the United States Treasury Regulations (the “ FIRPTA Certificate ”).

 

6.17 Pre-Merger Specified Loss Amount

Not later than two Business Days prior to the Closing, the Company shall deliver to Acquiror a written statement certifying as to the dollar amount of all Losses that are or will be part of the Pre-Merger Specified Loss Amount; provided, however , that in connection with the delivery of such written statement, the Company shall not be required to certify as to the dollar amount of any such Losses that constitute the Lump Sum Equivalent Amount (as agreed in writing by Acquiror and the Company or as determined pursuant to a final arbitration ruling issued in accordance with the principles and procedures set forth on Annex 6.3(c) ) of any settlement of the Specified Litigation that is not a Lump Sum Settlement or any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment.

ARTICLE VII

PRE-CLOSING PERIOD, TERMINATION, AMENDMENT AND WAIVER

 

7.1 Primary Period; Secondary Period

(a) The period commencing upon the date of this Agreement and ending at the Effective Time (the “ Pre-Closing Period ”) shall be comprised of two time periods (the “Primary Period” and the “Secondary Period”), as follows:

(i) “ Primary Period ” shall mean the period commencing upon the date of this Agreement and ending upon the earliest of (a) the Primary Period Expiration Time (as it may be extended pursuant to Section 7.1(b) ), (b) the delivery by Acquiror to the Company of a written notice in the form attached hereto as Exhibit D (the “ Secondary Period Election Notice ”), or (c) any termination of this Agreement in accordance with Section 7.2 . Notwithstanding anything to the contrary herein, Acquiror shall not deliver a Secondary Period Election Notice until the earliest of (A) one (1) Business Day prior to the day that includes the then-current Primary Period Expiration Time, (B) the date ten (10) Business Days after the delivery by Acquiror to the Company of a Disclosure Memorandum Update Request, or (C) the date on which Acquiror receives from the Company a Disclosure Schedule Memorandum Update in response to such Disclosure Memorandum Update Request.

 

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(ii) “ Secondary Period ” shall mean the period commencing upon the delivery by Acquiror to the Company of a Secondary Period Election Notice (the date on which such notice is delivered, the “ Secondary Period Commencement Date ”) and ending upon the earlier of (a) the Effective Time or (b) any termination of this Agreement in accordance with Section 7.3 .

As used herein, the term “ Primary Period Expiration Time ” shall initially mean 11:59 p.m. Pacific Time on December 31, 2006. The Primary Period Expiration Time shall be subject to extension pursuant to Section 7.1(b) .

(b) Subject to the provisions of Sections 7.1(c) and 7.1(d) , at any time commencing on the 16th day of the calendar month that immediately precedes the month that includes the then-current Primary Period Expiration Time, but in any event prior to 11:59 p.m. Pacific Time on the 15 th day of the calendar month that includes the then-current Primary Period Expiration Time (the “ Primary Period Extension Deadline ”), at the sole and unilateral option and election of Acquiror, exercisable by delivery to the Company of a written notice in the form attached hereto as Exhibit E (the “ Primary Period Extension Notice ”), Acquiror shall be entitled to extend the Primary Period Expiration Time until the earlier of (i) 11:59 p.m. Pacific Time on the last day of the first full calendar month following the date of such Primary Period Extension Notice (the “ Extension Month ”), or (ii) the date that is 45 days after the Litigation Resolution Date (as defined in Section 7.1(c) ).

(c) Notwithstanding the provisions of Section 7.1(b) , (i) in no event shall Acquiror be entitled to deliver a Primary Period Extension Notice if the Litigation Resolution Date (as defined below) is prior to November 15, 2006, and (ii) in no event shall Acquiror be entitled to deliver more than one Primary Period Extension Notice following the date of the earliest to occur of the following (such date, the “ Litigation Resolution Date ”): (A) the date on which the Company enters into a Lump Sum Settlement of the Specified Litigation; (B) the date on which a Final Judgment that is a Lump Sum Judgment is entered by the court in connection with the Specified Litigation; (C) the date on which Acquiror and the Company enter into a written agreement with respect to the Lump Sum Equivalent Amount of either (x) a settlement of the Specified Litigation that is not a Lump Sum Settlement or (y) a Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment; or (D) the date on which a final arbitration ruling is issued in accordance with the principles and procedures set forth on Annex 6.3(c) with respect to the Lump Sum Equivalent Amount of either (x) a settlement of the Specified Litigation that is not a Lump Sum Settlement or (y) a Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment.

(d) Notwithstanding the provisions of Sections 7.1(b) , 7.1(c)(ii)(A) and 7.1(c)(ii)(C), (i) if Acquiror approves in writing (which approval Acquiror may grant or withhold in its sole and absolute discretion) the final terms of a definitive, unconditional written settlement agreement pursuant to which the Company and the other parties to the Specified Litigation propose to settle the Specified Litigation, whether or not the approval of Acquiror is required with respect to such settlement agreement pursuant to this Agreement, Acquiror agrees that it will deliver to the Company a Secondary Period Election Notice contemporaneously with the

 

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execution and delivery of such definitive settlement agreement, and (ii) if Acquiror enters into a written agreement with the Company as described in Section 7.1(c)(ii)(C) , Acquiror agrees that it will deliver to the Company a Secondary Period Election Notice contemporaneously with the execution and delivery of such written agreement.

(e) For each full calendar month commencing on or after January 1, 2007 during the Pre-Closing Period (“ Pre-Closing Period Month ”), Acquiror shall be obligated to make a loan to the Company (a “ Pre-Closing Period Loan ”), by not later than the close of business Pacific Time on the first Business Day coinciding with or following the 5 th day of such Pre-Closing Period Month, in an amount equal to $3,250,000; provided, however, that if (i) the Primary Period Extension Deadline has been extended to any date other than the last day of such Pre-Closing Period Month, and (ii) Acquiror has not delivered a Secondary Period Election Notice on or prior to the 5 th day of such Pre-Closing Period Month, the amount of the required Pre-Closing Period Loan for such Pre-Closing Period Month shall be equal to the product of (A) $3,250,000, multiplied by (B) a fraction (x) whose numerator is the number of days in such Pre-Closing Period Month through the Primary Period Extension Deadline, and (y) whose denominator is the number of days in such Pre-Closing Period Month. However, if (1) the amount of such Pre-Closing Period Loan is less than $3,250,000, and (2) after such Pre-Closing Period Loan is made, Acquiror delivers a Secondary Period Election Notice to the Company prior to the Primary Period Extension Deadline, then within two (2) Business Days after Acquiror delivers such Secondary Period Election Notice to the Company, Acquiror shall make an additional Pre-Closing Period Loan to the Company in an amount equal to the amount by which $3,250,000 exceeds the amount of such earlier Pre-Closing Period Loan. The Company shall, in connection with the making by Acquiror of each Pre-Closing Period Loan, issue to Acquiror a convertible promissory note having a face amount equal to the amount of such Pre-Closing Period Loan and otherwise in all material respects in the form of Exhibit F .

 

7.2 Termination During Primary Period

(a) This Agreement may be terminated and the Merger may be abandoned at any time during the Primary Period (notwithstanding any adoption of this Agreement and approval of the Merger by the Stockholders) by Acquiror in its sole and absolute discretion, with or without cause or good reason.

(b) This Agreement shall automatically terminate at the Primary Period Expiration Time (as it may be extended pursuant to Section 7.1(b) ) unless prior to the Primary Period Expiration Time (as it may be extended pursuant to Section 7.1(b) ), Acquiror delivers to the Company a Secondary Period Election Notice.

 

7.3 Termination During Secondary Period

This Agreement may be terminated and the Merger may be abandoned at any time during the Secondary Period (notwithstanding any adoption of this Agreement and approval of the Merger by the Stockholders):

(a) by mutual written consent of the Company and Acquiror;

 

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(b) by the Company, if the Merger has not been consummated by the End Date; provided, however , that the right to terminate this Agreement under this Section 7.3(b) shall not be available to the Company if the failure of the Company to perform any obligation, agreement or covenant under this Agreement or any of the other Operative Documents, or the failure of any of the Key Stockholders to perform any obligation, agreement or covenant under its Key Stockholder Agreement or any of the other Operative Documents to which such Key Stockholder is a party, has been the cause of, or resulted in, the failure of the Effective Time to occur on or before such date;

(c) by Acquiror, if the Merger has not been consummated by the End Date; provided, however , that the right to terminate this Agreement under this Section 7.3(c) shall not be available to Acquiror if the failure of Acquiror or Merger Sub to perform any obligation, agreement or covenant under this Agreement or any of the other Operative Documents has been the cause of, or resulted in, the failure of the Effective Time to occur on or before such date;

(d) by Acquiror if:

(i) any representation or warranty of the Company contained in this Agreement or any of the other Operative Documents shall have been inaccurate in any material respect as of the Secondary Period Commencement Date, or shall have become inaccurate in any material respect as of a date subsequent to the Secondary Period Commencement Date (as if made on and as of such subsequent date), such that (in either case) the condition set forth in Section 4.1 would not be satisfied; provided, however, that (A) in determining the accuracy of any representation or warranty for purposes of this provision, no effect shall be given to any “Company Material Adverse Effect” or other materiality qualifications, or any similar qualifications, that are contained or incorporated directly or indirectly in such representation or warranty and that would otherwise limit the scope or effect of such representation or warranty, and (B) any update of or modification to the Disclosure Memorandum made or purported to have been made on or after the Secondary Period Commencement Date shall be disregarded; or

(ii) any of the obligations, agreements or covenants of the Company contained in this Agreement or any of the other Operative Documents shall have been breached in any material respect;

provided, however , that if an inaccuracy in any representation or warranty of the Company as of a date subsequent to the date of this Agreement or a breach of an obligation, agreement or covenant by the Company contained in this Agreement or any of the other Operative Documents is curable by the Company through the use of commercially reasonable efforts during the 30-day period after Acquiror notifies the Company in writing of the existence of such inaccuracy or breach (the “ Company Cure Period ”), then Acquiror may not terminate this Agreement under this Section 7.3(d) as a result of such inaccuracy or breach prior to the expiration of the Company Cure Period, provided the Company, during the Company Cure Period, continues to exercise commercially reasonable efforts to cure such inaccuracy or breach;

(e) by the Company if:

 

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(i) any representation or warranty of Acquiror or Merger Sub contained in this Agreement shall have been inaccurate in any material respect as of the Secondary Period Commencement Date, or shall have become inaccurate in any material respect as of a date subsequent to the Secondary Period Commencement Date (as if made on and as of such subsequent date), such that (in either case) the condition set forth in Section 5.1 would not be satisfied; provided, however, that in determining the accuracy of any representation or warranty for purposes of this provision, no effect shall be given to any materiality qualifications, or any similar qualifications, that are contained or incorporated directly or indirectly in such representation or warranty and that would otherwise limit the scope or effect of such representation or warranty; or

(ii) if any of Acquiror’s or Merger Sub’s obligations, agreements or covenants contained in this Agreement shall have been breached in any material respect;

provided, however, that if an inaccuracy in or breach of any representation or warranty of Acquiror or Merger Sub as of a date subsequent to the date of this Agreement or a breach of an obligation, agreement or covenant by Acquiror or Merger Sub contained in this Agreement or any of the other Operative Documents is curable by Acquiror through the use of commercially reasonable efforts during the 30-day period after the Company notifies Acquiror in writing of the existence of such inaccuracy or breach (the “ Acquiror Cure Period ”), then the Company may not terminate this Agreement under this Section 7.3(e) as a result of such inaccuracy or breach prior to the expiration of the Acquiror Cure Period, provided Acquiror or Merger Sub (as the case may be), during the Acquiror Cure Period, continues to exercise commercially reasonable efforts to cure such inaccuracy or breach;

(f) by Acquiror if (i) there shall have occurred any Company Material Adverse Effect, or (ii) any event shall have occurred or circumstance shall exist that, in combination with any other events or circumstances, could reasonably be expected to have or result in a Company Material Adverse Effect; provided, however , that if any change, event, effect, claim, violation, inaccuracy, circumstance or other matter is expressly set forth in Schedule 2.7 to the Disclosure Memorandum in any Disclosure Memorandum Update delivered to Acquiror prior to the Secondary Commencement Date, and the Company specifically states in such Disclosure Memorandum Update that such change, event, effect, claim, violation, inaccuracy, circumstance or other matter constitutes a Company Material Adverse Effect, then Acquiror may not terminate this Agreement under this Section 7.3(f) as a result of such Company Material Adverse Effect;

(g) by Acquiror if a court of competent jurisdiction or other U.S. Governmental Entity shall have issued a final and nonappealable Order, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Merger;

(h) by the Company if a court of competent jurisdiction or other U.S. Governmental Entity shall have issued a final and nonappealable Order, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Merger, and the issuance of such Order or the taking of such action would result in the imposition of a material criminal or civil fine or penalty on the Stockholders; or

 

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(i) by Acquiror if the Required Company Stockholder Vote is not obtained within four hours after the execution and delivery of this Agreement.

 

7.4 Termination Procedure; Effect of Termination

(a) If Acquiror wishes to terminate this Agreement pursuant to Section 7.2 , then Acquiror shall deliver to the Company a written notice stating that Acquiror is terminating this Agreement.

(b) If a Party wishes to terminate this Agreement pursuant to Section 7.3 , then such Party shall deliver to the other Parties to this Agreement a written notice stating that such Party is terminating this Agreement and setting forth a description of the basis on which such Party is terminating this Agreement.

(c) Except as specifically provided in this Section 7.4 , in the event of the termination of this Agreement pursuant to Section 7.2 , there shall be no further obligation on the part of any Party; provided, however , that the Company shall remain liable for any breach by the Company of any representation, warranty, obligation, agreement or covenant that occurs prior to the termination of this Agreement.

(d) Except as specifically provided in this Section 7.4 , in the event of the termination of this Agreement pursuant to Section 7.3 , there shall be no further obligation on the part of any Party; provided, however , that each Party shall remain liable for any breach by such Party of any representation, warranty, obligation, agreement or covenant that occurs prior to the termination of this Agreement.

(e) Notwithstanding anything to the contrary in this Agreement, Section 6.7 , this Section 7.4 and Article IX shall survive any termination of this Agreement.

 

7.5 Amendment

This Agreement may not be amended except by an instrument in writing signed by Acquiror and the Company; provided, however , that no amendment may be made without the further approval of the Stockholders to the extent that such approval is required by the DGCL.

 

7.6 Waiver

At any time prior to the Effective Time, any Party may, by a writing delivered to the other Parties to this Agreement, (a) extend the time for the performance of any obligation or other act of any other Party, (b) waive any inaccuracy in the representations and warranties contained in this Agreement or in any document delivered pursuant hereto or (c) waive compliance with any obligation, agreement, covenant or condition contained in this Agreement. Any such extension or waiver shall be valid only if set forth in an instrument in writing signed by the Party or Parties to be bound thereby.

 

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ARTICLE VIII

SURVIVAL AND INDEMNIFICATION

 

8.1 Survival

(a) The obligations of the Non-Dissenting Holders under Section 8.2 with respect to the representations, warranties, obligations, agreements and covenants of the Company contained in this Agreement or in any certificate delivered pursuant hereto and the other matters set forth in Section 8.2 shall survive until the first anniversary of the Closing Date (the period from the Closing through such date being the “ Survival Period ”), and shall not be deemed waived or otherwise affected by any information furnished, any investigation made or any knowledge acquired with respect thereto, or by any notice delivered pursuant to Section 6.9 . Notwithstanding the foregoing, if at any time prior to or during the Survival Period, any Indemnified Party delivers to the Stockholder Representative Committee an Indemnity Claim Notice with respect to any Indemnity Claim, then the Survival Period with respect to the Indemnity Claim asserted in such Indemnity Claim Notice shall continue until such time as such Indemnity Claim is fully and finally resolved.

(b) All representations and warranties of Acquiror and Merger Sub, and all obligations, agreements and covenants of Acquiror and Merger Sub to be performed at or prior to the Effective Time, shall terminate and expire as of the Effective Time, and any Liability of Acquiror or Merger Sub with respect to such representations, warranties, obligations, agreements and covenants shall thereupon cease.

(c) For purposes of this Agreement, each statement or other item of information set forth in the Disclosure Memorandum or in any Disclosure Memorandum Update shall be deemed to be a representation and warranty made by the Company in this Agreement.

 

8.2 Indemnification by the Non-Dissenting Holders

Subject to the provisions of Section 8.3 , the Non-Dissenting Holders severally and not jointly shall indemnify, compensate, reimburse and hold harmless Acquiror and the other Indemnified Parties, solely out of the Holdback Amount (except to the extent provided in Section 8.3(e) ), against, for and from all Losses that are directly or indirectly suffered or incurred by any of the Indemnified Parties or to which any of the Indemnified Parties may otherwise become subject (regardless of whether or not such Losses relate to any Third-Party Claim) and which directly or indirectly arise from or as a result of, or are directly or indirectly connected with:

(a) any inaccuracy in, or breach of, any representation or warranty made by the Company in this Agreement, or in any certificate delivered pursuant hereto, whether as of the date of this Agreement, as of the Secondary Period Commencement Date (as if such representation and warranty had been made on and as of the Secondary Period Commencement Date) or as of the Closing Date (as if such representation and warranty had been made on and as of the Closing Date), in either case without giving effect to (i) any “Company Material Adverse Effect” or other materiality qualification, or any similar qualification, that is contained or incorporated directly or indirectly in such representation or warranty and that would otherwise limit the scope or effect of such representation or warranty, or (ii) any Disclosure Memorandum Update made or purported to have been made on or after the date of this Agreement;

 

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(b) any failure by the Company to perform or comply, in whole or in part, with any obligation, agreement or covenant in this Agreement;

(c) the exercise by any Dissenting Holder of such Dissenting Holder’s appraisal rights under the DGCL, including the amount, if any, by which (A) the aggregate amount ultimately awarded to a Dissenting Holder in any appraisal proceeding exceeds (B) the consideration to which such Dissenting Holder would have been entitled to receive pursuant to Section 1.7.1(b) , Section 1.7.1(c) , Section 1.7.1(d) or Section 1.7.1(e) , as applicable, had such Dissenting Holder been a Non-Dissenting Holder; and

(d) except as otherwise expressly provided in Section 8.3(f) : any claim for indemnity or reimbursement asserted by any Company Associate against the Company or the Surviving Corporation pursuant to the provisions of the Company Certificate of Incorporation, the Company Bylaws or any individual agreements identified in Annex 6.13(a) , applicable Law or otherwise, and whether asserted in accordance with Section 6.13 or otherwise;

(e) any Post-Merger Specified Litigation Losses; and

(f) any Legal Proceeding relating to any matter referred to in clause “(a),” clause “(b),” clause “(c),” clause “(d)” or clause “(e)” above (including any Legal Proceeding commenced by any Indemnified Party for the purpose of enforcing any of its rights under this Section 8.2 ).

 

8.3 Threshold and Limitations

(a) The Indemnified Parties shall not be entitled to receive any indemnification payment with respect to any Indemnity Claim under Section 8.2(1)(a) until the aggregate Losses for which such Indemnified Parties would be otherwise entitled to receive indemnification with respect to Indemnity Claims under Section 8.2(1)(a) exceed $650,000 (the “ Threshold ”); provided, however , that once the aggregate Losses with respect to Indemnity Claims under Section 8.2(1)(a) exceed the Threshold, such Indemnified Parties shall be entitled to indemnification for the aggregate amount of all Losses with respect to Indemnity Claims under Section 8.2(1)(a) without regard to the Threshold.

(b) Subject to Section 8.3(e) : (i) the indemnification remedy provided by this Article VIII shall be the sole monetary remedy for any alleged breach of the representations, warranties or covenants made by the Company hereunder; (ii) the total liability of the Non-Dissenting Holders pursuant to Section 8.2 shall be limited to the Holdback Amount, and the Holdback Amount shall be the sole source of monetary recovery for any Indemnity Claims made by any Indemnified Party hereunder; and (iii) the total liability of the Non-Dissenting Holders pursuant to Section 8.2 with respect to Indemnity Claims that are not Pre-Closing Indemnity Claims shall be limited to $36,500,000.

 

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(c) No Non-Dissenting Holder shall have, nor shall any Non-Dissenting Holder exercise or assert (or attempt to exercise or assert), any right of contribution, right of indemnity or other right or remedy against Acquiror or against the Surviving Corporation to satisfy or otherwise seek reimbursement for any indemnification obligation or any other liability to which such Non-Dissenting Holder may become subject under or in connection with this Agreement.

(d) The Parties acknowledge and agree that, if the Surviving Corporation suffers, incurs or otherwise becomes subject to any Losses as a result of or in connection with any inaccuracy in, or breach of or failure to perform or comply with, any representation, warranty, obligation, agreement or covenant, then (without limiting any of the rights of the Surviving Corporation as an Indemnified Party) Acquiror shall also be deemed, by virtue of its ownership of the stock of the Surviving Corporation, to have incurred Losses as a result of and in connection with such inaccuracy, misrepresentation, breach, failure to perform or failure to comply.

(e) Nothing contained in this Agreement shall limit the rights of any Indemnified Party (i) to seek or obtain from any Person any relief or remedy to which such Indemnified Party may otherwise be entitled under applicable Law with respect to any fraud, intentional misrepresentation or willful misconduct committed by or behalf of such Person, or (ii) to seek or obtain injunctive relief, specific performance, rescission or any other equitable remedy to which such Indemnified Party may otherwise be entitled.

(f) For the avoidance of doubt and notwithstanding anything to the contrary herein: (i) in the event that the Litigation Resolution Date is prior to the Closing Date, the Non-Dissenting Holders shall have no liability, whether pursuant to Section 8.2 or otherwise, for any Losses suffered or incurred by any of the Indemnified Parties or to which any of the Indemnified Parties may otherwise become subject that exclusively arise from or as a result of any settlement of the Specified Litigation after the Litigation Resolution Date or any appeal of a Final Judgment entered into in the Specified Litigation, including any costs or expenses incurred by the Indemnified Parties in prosecuting or defending such appeal and any judgment that may be entered against the Company as a result of additional proceedings in the Specified Litigation after the Litigation Resolution Date (including reversal on appeal, entry of judgment after appeal, remand for new trial or any combination of the foregoing); provided, however , that notwithstanding the foregoing, the Aggregate Transaction Value shall be reduced (in accordance the definition of such term) by the Pre-Merger Specified Litigation Loss Amount; and (ii) in no event shall any of the Non-Dissenting Holders have any entitlement to any payment or benefit whatsoever by reason of (A) any reduction in the amount of any Final Judgment entered by the court in connection with the Specified Litigation following the Litigation Resolution Date, (B) any settlement of the Specified Litigation following the Litigation Resolution Date or any appeal of a Final Judgment entered into in the Specified Litigation, or (C) any other fact, event or circumstance involving or relating in any way to the Specified Litigation (whether such fact, event or circumstance exists or occurs prior to or following the Litigation Resolution Date).

 

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8.4 Procedure for Indemnification

(a) If any Indemnified Party has incurred or suffered or claims to have incurred or suffered, or believes that it may incur or suffer, Losses for which it is or may be entitled to be indemnified, compensated, reimbursed or held harmless under this Article VIII , such Indemnified Party may deliver an Indemnity Claim Notice to the Stockholder Representative Committee, which shall (i) describe the general facts and circumstances on which the asserted Indemnity Claim is based, and (ii) contain a good faith, non-binding, preliminary estimate of the aggregate dollar amount of actual and potential Losses that have arisen and may arise as a result of the matter referred to in such notice (the aggregate amount of such estimate, as it may be modified by such Indemnified Party in good faith from time to time, being referred to as the “ Claimed Amount ”), and the provisions in this Agreement on which the Indemnity Claim is based.

(b) During the 30-day period commencing upon the delivery by an Indemnified Party to the Stockholder Representative Committee of an Indemnity Claim Notice (the “ Dispute Period ”), the Stockholder Representative Committee shall deliver to the Indemnified Party a written response (the “ Response Notice ”) in which the Stockholder Representative Committee: (i) agrees that the full Claimed Amount is owed to the Indemnified Party; (ii) agrees that part (but not all) of the Claimed Amount (the “ Agreed Amount ”) is owed to the Indemnified Party; or (iii) asserts that no part of the Claimed Amount is owed to the Indemnified Party. Any part of the Claimed Amount that is not agreed by the Stockholder Representative Committee to be owed to the Indemnified Party pursuant to the Response Notice (or the entire Claimed Amount, if the Stockholder Representative Committee asserts in the Response Notice that no part of the Claimed Amount is owed to the Indemnified Party) shall be referred to as the “ Contested Amount ” (it being understood that the Contested Amount shall be modified from time to time to reflect any good faith modifications by the Indemnified Party to the Claimed Amount). If a Response Notice is not received by the Indemnified Party prior to the expiration of the Dispute Period, then the Stockholder Representative Committee shall be conclusively and irrevocably deemed to have agreed that the full Claimed Amount is owed to the Indemnified Party.

(c) If the Stockholder Representative Committee delivers a Response Notice to the Indemnified Party agreeing that the full Claimed Amount with respect to an Indemnity Claim is owed to the Indemnified Party, or if the Stockholder Representative Committee does not deliver a Response Notice to the Indemnified Party during the Dispute Period, then, within three days following the earlier of the delivery of such Response Notice to the Indemnified Party or the expiration of the Dispute Period, Acquiror shall become entitled to permanently retain out of the Holdback Amount an amount equal to the lesser of (i) the full Claimed Amount or (ii) the portion of the Holdback Amount available therefor (as provided above) not previously permanently retained by Acquiror based on other Indemnity Claims.

(d) If the Stockholder Representative Committee delivers a Response Notice to the Indemnified Party during the Dispute Period agreeing that less than the full Claimed Amount with respect to an Indemnity Claim is owed to the Indemnified Party, then, within three days following the delivery of such Response Notice to the Indemnified Party, Acquiror shall

 

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become entitled to permanently retain out of the Holdback Amount an amount equal to the lesser of (i) the Agreed Amount or (ii) the portion of the Holdback Amount available therefor (as provided above) not previously permanently retained by Acquiror based on other Indemnity Claims.

In addition, if the Stockholder Representative Committee delivers a Response Notice to the Indemnified Party during the Dispute Period agreeing that less than the full Claimed Amount with respect to an Indemnity Claim is owed to the Indemnified Party, then the Stockholder Representative Committee and the Indemnified Party shall attempt in good faith to resolve the dispute related to the Contested Amount. If the Indemnified Party and the Stockholder Representative Committee resolve such dispute in writing, then their resolution of such dispute shall be binding on the Stockholder Representative Committee, the Non-Dissenting Holders and the Indemnified Party and a settlement agreement stipulating the amount owed to the Indemnified Party (the “ Stipulated Amount ”) shall be signed by the Indemnified Party and the Stockholder Representative Committee. Within three days after the execution of such settlement agreement, Acquiror shall become entitled to permanently retain out of the Holdback Amount an amount equal to the lesser of (i) the Stipulated Amount or (ii) the portion of the Holdback Amount available therefor (as provided above) not previously permanently retained by Acquiror based on other Indemnity Claims.

(e) If the Stockholder Representative Committee and the Indemnified Party are unable to resolve the dispute relating to any Contested Amount with respect to an Indemnity Claim during the 30-day period commencing upon the delivery of the Response Notice to the Indemnified Party, then either the Indemnified Party or the Stockholder Representative Committee may submit the contested portion of the indemnification claim to binding arbitration in San Francisco, California, accordance with the JAMS Comprehensive Arbitration Rules and Procedures then in effect. Arbitration will be conducted by one arbitrator, mutually selected by Acquiror and the Stockholder Representative Committee; provided, however, that if Acquiror and the Stockholder Representative Committee fail to mutually select an arbitrator within 15 Business Days after the contested portion of the indemnification claim is submitted to arbitration, then the arbitrator shall be selected by JAMS in accordance with its Comprehensive Arbitration Rules and Procedures then in effect. The Parties agree to use commercially reasonable efforts to cause the arbitration hearing to be conducted within 75 days after the appointment of the arbitrator, and to use commercially reasonable efforts to cause the decision of the arbitrator to be furnished within 15 days after the conclusion of the arbitration hearing. The arbitrator’s authority shall be confined to: (A) whether the Indemnified Party is entitled to recover the Contested Amount (or a portion thereof), and the portion of the Contested Amount the Indemnified Party is entitled to recover; and (B) whether either party to the arbitration shall be required to bear and pay all or a portion of the other party’s attorneys’ fees and other expenses relating to the arbitration. The final decision of the arbitrator shall include the dollar amount of the award to the Indemnified Party, if any (the “ Award Amount ”), and shall be furnished to the Stockholder Representative Committee and the Indemnified Party in writing, shall constitute a conclusive determination of the issues in question, binding upon the Stockholder Representative Committee, the Non-Dissenting Holders and the Indemnified Party. Within three days following the receipt of the final award of the arbitrator setting forth the Award Amount, Acquiror shall become entitled to permanently retain out of the Holdback Amount an amount equal to the lesser of (i) the Award Amount or (ii) the portion of the Holdback Amount available therefor (as provided above) not previously permanently retained by Acquiror based on other Indemnity Claims.

 

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(f) In the event of the assertion or commencement by any Person of any Third-Party Claim (whether against the Surviving Corporation, against Acquiror or against any other Person) with respect to which Acquiror determines that any Indemnified Party may be entitled to be held harmless, indemnified or reimbursed pursuant to this Article VIII , (a) Acquiror shall notify the Stockholder Representative Committee promptly after Acquiror receives written notice of such Third-Party Claim (it being understood that any failure by Acquiror to so promptly notify the Stockholder Representative Committee shall have no effect on an Indemnified Party’s ability to recover Damages pursuant to this Article VIII , except to the extent that the defense of such Third-Party Claim is materially prejudiced thereby), and (b) Acquiror shall proceed with the defense of such Third-Party Claim with counsel reasonably acceptable to the Stockholder Representative Committee. In connection with the defense of any such Third-Party Claim: (i) all out-of-pocket expenses relating to the defense of such Third-Party Claim shall, subject to Section 8.3 , be borne and paid exclusively out of the Holdback Amount through a permanent retention of such amounts by Acquiror; (ii) Acquiror shall not settle, adjust or compromise such Third-Party Claim without the prior written consent of the Stockholder Representative Committee (which consent shall not be unreasonably withheld or delayed); and (iii) the Stockholder Representative Committee shall cooperate with Acquiror and shall be entitled to consult with Acquiror from time to time in connection with the defense or handling of such Third-Party Claim with its own counsel and at its own expense.

(g) Nothing in this Article VIII shall limit any rights of setoff or other similar rights that the Stockholder Representative Committee, Acquiror or any of the other Indemnified Parties may have at common law or otherwise.

 

8.5 Holdback Payments

(a) Within 30 days following the expiration of the Survival Period, Acquiror shall make, or shall cause the Surviving Corporation to make, a payment to the Non-Dissenting Holders in an aggregate amount equal to the amount (if any) by which (i) the Primary Holdback Amount, reduced by any amounts previously permanently retained therefrom by Acquiror or other Indemnified Parties in accordance with Section 8.4 , exceeds (ii) the aggregate amount of the Claimed Amounts under all Indemnity Claim Notices (including Indemnity Claim Notices with respect to Post-Merger Specified Litigation Losses) that remain unresolved at such time (the amount of such excess, the “ Initial Holdback Payment ”).

(b) Following the date of the Initial Holdback Payment (the “ Initial Payment Date ”), within 30 days following the date of final resolution of any Indemnity Claim Notice that remained unresolved as of the Initial Payment Date, Acquiror shall make, or shall cause the Surviving Corporation to make, a payment to the Non-Dissenting Holders in an amount equal to the lesser of (i) the portion (if any) of the Claimed Amount under such Indemnity Claim Notice that Acquiror is not entitled to permanently retain under the applicable provision of Section 8.4 pursuant to which such Indemnity Claim Notice was finally resolved, or (ii) the amount (if any) by which (x) the Primary Holdback Amount, reduced by any amounts permanently retained therefrom by Acquiror or other Indemnified Parties in accordance with Section 8.4 , exceeds (y) the aggregate amount of the Claimed Amounts under all Indemnity Claim Notices that remain unresolved at such time (the lesser of such amounts, a “ Subsequent Holdback Payment ”).

 

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(c) Within 30 days following the date of final resolution of any Indemnity Claim Notice with respect to a Pre-Closing Indemnity Claim, Acquiror shall make, or shall cause the Surviving Corporation to make, a payment to the Non-Dissenting Holders in an amount equal to the amount (if any) by which (i) the Supplemental Holdback Amount, reduced by any amounts permanently retained therefrom by Acquiror or other Indemnified Parties in accordance with Section 8.4 , exceeds (ii) the sum of (A) the aggregate amount of the Claimed Amounts under all Indemnity Claim Notices with respect to Pre-Closing Indemnity Claims that remain unresolved at such time, plus (B) the aggregate amount previously paid to Non-Dissenting Holders pursuant to this Section 8.5(c) (each such payment, a “ Supplemental Holdback Payment ”).

(d) The Initial Holdback Payment, Subsequent Holdback Payments and Supplemental Holdback Payments (if any) shall be paid to and allocable among the Non-Dissenting Holders in accordance with their respective Holdback Percentages.

 

8.6 Exercise of Remedies by Indemnified Parties Other than Acquiror

No Indemnified Party (other than Acquiror or any successor thereto or assign thereof) shall be permitted to assert any indemnification claim or exercise any other remedy under this Agreement unless Acquiror (or any successor thereto or assign thereof) shall have consented to the assertion of such indemnification claim or the exercise of such other remedy.

 

8.7 Stockholder Representative Committee

(a) Each of the Non-Dissenting Holders (by executing the applicable Letter of Transmittal or by delivering its certificates or other instruments representing shares of Company Capital Stock to the Paying Agent in accordance with the provisions of Section 1.7.3, or by executing the Stockholder Consent (or both)), shall automatically be deemed to have irrevocably authorized and appointed the three members of the Stockholder Representative Committee, with full power of substitution and resubstitution, as its representatives and true and lawful attorneys-in-fact and agents, with full power of substitution, to act in its name, place and stead for purposes of executing any documents and taking any actions that the Stockholder Representative Committee may, in its sole discretion, determine to be necessary, desirable or appropriate in all matters relating to or arising out of this Agreement, including in connection with any claim for indemnification, compensation or reimbursement as contemplated by this Article VIII and to execute in the name and on behalf of such Non-Dissenting Holder any agreement, certificate, instrument or document to be delivered by such Non-Dissenting Holder in connection with any of the foregoing. Such power of attorney is coupled with an interest and is irrevocable, may be delegated by the Stockholder Representative Committee and shall survive the dissolution, death or incapacity of each of the Non-Dissenting Holders. Each of the members of the Stockholder Representative Committee hereby accepts his appointment as a member of the Stockholder Representative Committee.

 

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(b) The approval by a majority of the members of the Stockholder Representative Committee shall constitute the action of the Stockholder Representative Committee hereunder. Notwithstanding the foregoing, for all purposes hereunder, the Company shall be entitled to conclusively rely on any statement or representation by any member of the Stockholder Representative Committee that a matter, action or decision has been approved by a majority of the members of the Stockholder Representative Committee, and any such statement or representation shall be binding upon the Stockholder Representative Committee and all of the members thereof, and on the Non-Dissenting Holders.

(c) Notwithstanding anything to the contrary contained in this Agreement or in any other Contract entered into in connection with any of the Contemplated Transactions, each Indemnified Party shall be entitled to deal exclusively with the Stockholder Representative Committee on all matters relating to Article VIII , and shall be entitled to rely conclusively (without further evidence of any kind whatsoever) on any document entered into or purported to be entered into on behalf of any Non-Dissenting Holder by the Stockholder Representative Committee with respect to matters relating to Article VIII , and on any other action taken or purported to be taken on behalf of any Non-Dissenting Holder by the Stockholder Representative Committee with respect to matters relating to Article VIII , as fully binding upon such Non-Dissenting Holder.

(d) Members of the Stockholder Representative Committee may resign at any time. Upon such resignation, the Non-Dissenting Holders shall appoint a new member of the Stockholder Representative Committee to replace such resigning member of the Stockholder Representative Committee with the same powers and duties as such resigning member of the Stockholder Representative Committee, provided that such newly appointed member of the Stockholder Representative Committee shall have been a Stockholder immediately prior to the Effective Time or a Representative of an Entity that was a Stockholder immediately prior to the Effective Time.

(e) If any member of the Stockholder Representative Committee or any successor shall die, become disabled or otherwise become unable to act as a member of the Stockholder Representative Committee, a replacement shall promptly be appointed by a writing signed by the Non-Dissenting Holders, provided that such newly appointed member of the Stockholder Representative Committee shall have been a Stockholder immediately prior to the Effective Time or a Representative of an Entity that was a Stockholder immediately prior to the Effective Time. If for any reason there are no remaining members of the Stockholder Representative Committee at any time, all references in this Agreement to the Stockholder Representative Committee shall be deemed to refer to the Non-Dissenting Holders.

(f) All expenses incurred by the Stockholder Representative Committee in connection with the performance of its duties as Stockholder Representative Committee shall be borne and paid exclusively by the Non-Dissenting Holders.

(g) On the Closing Date, if previously requested in writing by the Stockholder Representative Committee, Acquiror shall deposit with a third party escrow agent to be appointed by the Stockholder Representative Committee, in accordance with the terms and

 

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conditions of an escrow agreement in form and substance approved by Acquiror (such approval not to be unreasonably withheld), a sum of money determined by the Stockholder Representative Committee in its sole discretion, as evidenced by a written notice delivered by the Stockholder Representative Committee to Acquiror prior to the Closing Date, such sum not to exceed $500,000 (the “ Stockholder Representative Committee Escrow Amount ”), to provide for the reimbursement of expenses incurred by the Stockholder Representative Committee in connection with the performance of its duties under this Agreement. The payment of the Stockholder Representative Committee Escrow Amount by Acquiror to such escrow agent shall completely discharge Acquiror’s obligations with respect to such amount, and in no event shall Acquiror have any responsibility or liability whatsoever for the manner in which the Stockholder Representative Committee administers the Stockholder Representative Committee Escrow Amount, or for causing or ensuring that all or any portion of the Stockholder Representative Committee Escrow Amount is ultimately paid or distributed to Non-Dissenting Holders. The Stockholder Representative Committee Escrow Amount shall have the effect of reducing the Aggregate Transaction Value, as provided in the definition of “Aggregate Transaction Value” herein.

(h) No member of the Stockholder Representative Committee shall be liable to any Non-Dissenting Holder for any act done or omitted hereunder as a member of the Stockholder Representative Committee while acting in good faith and in the absence of gross negligence. The Non-Dissenting Holders shall severally indemnify each Stockholder Representative Committee member and hold each member of the Stockholder Representative Committee harmless against any loss, liability or expense incurred without gross negligence or bad faith on the part of any Stockholder Representative Committee member and arising out of or in connection with the acceptance or administration of the Stockholder Representative Committee’s duties hereunder, including the reasonable fees and expenses of any legal counsel retained by the Stockholder Representative Committee.

(i) Each Non-Dissenting Holder acknowledges that members of the Stockholder Representative Committee or their Affiliates may have in the past performed and may in the future perform services for Acquiror or its Affiliates in matters unrelated to the Contemplated Transactions and that, so long as a Stockholder Representative Committee member fulfills his or her obligations pursuant to Section 8.7(h) , such activities shall not constitute a breach by a Stockholder Representative Committee member of this Section 8.7 .

ARTICLE IX

GENERAL

 

9.1 Expenses

Subject to Article VIII , whether or not the Contemplated Transactions are consummated, each Party will pay its own fees and expenses incident to the negotiation, preparation and execution of this Agreement and the other Operative Documents, including all legal, accounting and advisory fees; provided, however, that (a) if the Parties file premerger notification and report forms pursuant to the HSR Act during the Primary Period, Acquiror shall bear and pay 100% of all filing fees in connection with the filing by the Parties of such forms, and (b) if the Parties file

 

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premerger notification and report forms pursuant to the HSR Act during the Secondary Period, Acquiror and the Company shall each bear and pay 50% of all filing fees in connection with the filing by the Parties of the premerger notification and report forms relating to the Merger under the HSR Act and the filing of any notice or other document under any other Antitrust Law. Should any suit or other action be brought hereunder, the attorneys’ fees and expenses of the prevailing Party shall be paid by the other Party to such action.

 

9.2 Notices

Any notice or other communication required or permitted to be delivered to any Party under this Agreement shall be in writing and shall be deemed properly delivered, given and received when delivered (by hand, by registered mail, by courier or express delivery service or by facsimile) to the address or facsimile telephone number set forth beneath the name of such Party below (or to such other address or facsimile telephone number as such Party shall have specified in a written notice given to the other Parties).

TO ACQUIROR OR MERGER SUB:

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Fax: (650) 522-5537

Attention: General Counsel

with a copy to:

Cooley Godward LLP

3000 El Camino Real

Five Palo Alto Square

Palo Alto, CA 94306

Fax: (650) 849-7400

Attention: Robert L. Jones

TO THE COMPANY:

Corus Pharma, Inc.

2025 1 st Avenue, Suite 800

Seattle, WA 98121

Fax: (206) 728-5095

Attention: Chief Executive Officer

TO THE STOCKHOLDER REPRESENTATIVE COMMITTEE:

Rodney A. Ferguson, Ph.D.

Managing Director

Panorama Capital

2440 Sand Hill Road, Suite 302

Menlo Park, CA 94025

Fax: (650) 234-1437

 

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in the case of the Company or the Stockholder Representative Committee, with a copy to:

Orrick, Herrington & Sutcliffe LLP

719 Second Avenue, Suite 900

Seattle, WA 98104

Fax: (206) 839-4301

Attention: Alan C. Smith

 

9.3 Severability

If any term or other provision of this Agreement is held to be invalid, illegal or incapable of being enforced by any rule of Law, or public policy, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect. If the Final Judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the Parties agree that the court making such determination shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the Parties agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term.

 

9.4 Entire Agreement

This Agreement, the other Operative Documents and the Non-Disclosure Agreement constitute the entire agreement among the Parties with respect to the subject matter hereof and thereof and supersede all prior agreements and undertakings, both written and oral, among the Parties, or any of them, with respect to the subject matter hereof and thereof.

 

9.5 Specific Performance; Remedies Cumulative

Each of the Parties acknowledges and agrees that the other Parties would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached. Accordingly, each of the Parties agrees that the other Parties shall be entitled to an injunction to prevent breaches of the provisions of this Agreement and to enforce specifically this Agreement and the terms and provisions hereof in any competent court having jurisdiction over the Parties, in addition to any other remedy to which they may be entitled at Law or in equity. Except as otherwise set forth in this Agreement, the rights and remedies of the Parties shall be cumulative (and not alternative).

 

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9.6 Successors and Assigns; Assignment

This Agreement shall be binding upon: the Company and its successors and assigns (if any); Acquiror and its successors and assigns (if any); Merger Sub and its successors and assigns (if any); and the Stockholder Representative Committee (including its current and future members). This Agreement shall inure to the benefit of: the Company; Acquiror; Merger Sub; the other Indemnified Parties (subject to Article VIII ); the Stockholders’ Representative; and the respective successors and assigns (if any) of the foregoing. This Agreement shall not be assigned by operation of Law or otherwise; provided, however , that Merger Sub’s rights and obligations may be assigned to and assumed by Acquiror or any other corporation wholly owned (directly or through intermediate wholly owned Subsidiaries) by Acquiror, and Acquiror may freely assign any or all of its rights under this Agreement (including its indemnification rights under Article VIII ), in whole or in part, to any successor to all or substantially all of the business of Acquiror or the Surviving Corporation, whether by merger, acquisition of assets or otherwise, without obtaining the consent or approval of any other Party or of any other Person; provided, however , that any such assignment does not affect the economic or legal substance of any of the Contemplated Transactions. No Stockholder may assign any rights to receive merger consideration or any other rights under this Agreement.

 

9.7 Parties in Interest

Except as otherwise provided in Section 6.13 and except for the Indemnified Parties, nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

 

9.8 Governing Law; Venue

This Agreement shall be governed by, and construed in accordance with, the Laws of the State of Delaware applicable to Contracts executed in and to be performed in that state. Except as otherwise provided in Article VIII , any Legal Proceeding relating to this Agreement or the enforcement of any provision of this Agreement may be brought or otherwise commenced in the Court of Chancery of the State of Delaware or in any state or federal court located in San Francisco, California. Each Party to this Agreement: (a) irrevocably and unconditionally consents and submits to the jurisdiction and venue of the Court of Chancery of the State of Delaware and the state and federal courts located in San Francisco, California; (b) agrees that the Court of Chancery of the State of Delaware and each state and federal court located in San Francisco, California shall be deemed to be a convenient forum; and (c) agrees not to assert (by way of motion, as a defense or otherwise), in any such Legal Proceeding commenced in the Court of Chancery of the State of Delaware or the any state or federal court located in San Francisco, California, any claim that such Party is not subject personally to the jurisdiction of such court, that such Legal Proceeding has been brought in an inconvenient forum, that the venue of such Legal Proceeding is improper or that this Agreement or the subject matter of this Agreement may not be enforced in or by such court.

 

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9.9 Headings

The descriptive headings contained in this Agreement are included for convenience of reference only and shall not affect in any way the meaning or interpretation of this Agreement.

 

9.10 Counterparts

This Agreement may be executed and delivered (including by facsimile transmission) in one or more counterparts, and by the different Parties in separate counterparts, each of which when executed and delivered shall be deemed to be an original but all of which taken together shall constitute one and the same agreement.

 

9.11 Waiver

(a) No failure on the part of any Person to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of any Person in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy.

(b) No Person shall be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of such Person; and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given.

 

9.12 Further Assurances

Each Party shall execute and cause to be delivered to each other Party such instruments and other documents, and shall take such other actions, as such other party may reasonably request (prior to, at or after the Closing) for the purpose of carrying out or evidencing any of the Contemplated Transactions.

 

9.13 Construction

(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include the masculine and feminine genders.

(b) The Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement.

(c) As used in this Agreement and the Schedules and Annexes to this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”

 

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(d) For purposes of this Agreement, e-mail and other forms of electronic communications shall be deemed to be written communications. An e-mail or other electronic communication shall be deemed to have been provided to and received by the Company if an officer or other employee of the Company who has or had any authority or responsibility relating to the subject matter of such communication shall have received such communication or a copy thereof (whether directly from the sender or otherwise).

(e) Except as otherwise indicated, (i) all references in this Agreement to “Articles,” “Sections,” “Exhibits,” “Schedules” and “Annexes” are intended to refer to Articles or Sections of this Agreement, Exhibits to this Agreement, Schedules to the Disclosure Memorandum and Annexes to this Agreement (as applicable), and (ii) all references in this Agreement to dollar amounts are intended to refer to U.S. dollars.

ARTICLE X

CERTAIN DEFINITIONS

Abaris ” shall mean the company formerly known as Abaris Pharma, Inc., which was merged into the Company on January 1, 2004.

Acquiror Common Stock ” shall mean Acquiror’s common stock, par value $0.001 per share.

Acquiror-Held Company Securities ” shall mean (i) all Acquiror-Held Series C Shares, and (ii) any shares of Company Capital Stock issued to Acquiror upon the conversion of any notes issued to Acquiror pursuant to Section 7.1(e) .

Affiliate ” of any Person shall mean another Person that directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such first Person; provided, however , that an Entity in which a Key Stockholder holds an equity interest or that is otherwise controlled by a Key Stockholders shall not be considered an Affiliate of the Company solely as a result of such ownership or control by such Key Stockholder.

Aggregate Closing Transaction Value ” shall mean the amount (if any) by which (a) the Aggregate Transaction Value exceeds (b) the Holdback Amount.

Aggregate Exercise Amount ” shall mean the aggregate dollar amount payable to the Company as purchase price for the exercise of unexercised Company Stock Options that are outstanding immediately prior to the Effective Time.

Aggregate Non-Dissenting Residual Amount ” shall mean the sum of the following:

(a) the product of (i) the number of shares of Series A Preferred Stock outstanding immediately prior to the Effective Time held by Non-Dissenting Holders multiplied by (ii) 1.8240647 multiplied by (iii) the Residual Per Share Amount;

 

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(b) the product of (i) the number of shares of Series B Preferred Stock outstanding immediately prior to the Effective Time held by Non-Dissenting Holders multiplied by (ii) the Residual Per Share Amount;

(c) the product of (i) the number of shares of Series C Preferred Stock (other than Acquiror-Held Series C Shares) outstanding immediately prior to the Effective Time held by Non-Dissenting Holders multiplied by (ii) the Residual Per Share Amount; and

(d) the product of (i) the number of shares of Company Common Stock outstanding immediately prior to the Effective Time held by Non-Dissenting Holders multiplied by (ii) the Residual Per Share Amount.

Aggregate Preference Amount ” shall mean the sum of the following:

(a) the product of (i) the Series A Preference Amount multiplied by (ii) the aggregate number of shares of Series A Preferred Stock outstanding immediately prior to the Effective Time; plus

(b) the product of (i) the Series B Preference Amount multiplied by (ii) the aggregate number of shares of Series B Preferred Stock outstanding immediately prior to the Effective Time; plus

(c) the product of (i) the Series C Preference Amount multiplied by (ii) the aggregate number of shares of Series C Preferred Stock (other than Acquiror-Held Series C Shares) outstanding immediately prior to the Effective Time.

Aggregate Transaction Value ” shall mean the amount by which (a) $365,000,000, exceeds (b) the sum of (i) the Pre-Merger Specified Litigation Loss Amount, plus (ii) the Pre-Closing Indemnity Settlement Amount, plus (iii) the Stockholder Representative Committee Escrow Amount plus (iv) the Eligible Debt Securities Amount.

Agreement ” shall mean this Agreement and Plan of Merger (including the Disclosure Memorandum), as it may be amended from time to time.

Asset ” shall mean all assets of any nature whatsoever, whether real, personal or mixed, tangible or intangible.

Balance Sheet Date ” shall mean December 31, 2005.

Business Day ” shall mean any day other than a Saturday, Sunday or a day on which banking institutions in Seattle, Washington are authorized or obligated by Law or executive order to be closed.

CERCLA ” shall mean the federal Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended from time to time.

 

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Certificate of Merger ” shall mean the certificate of merger with respect to the Merger, containing the provisions required by, and executed in accordance with, the DGCL.

Change in Control Agreements ” shall mean those certain Change in Control Severance Agreements between the Company and the respective CIC Employees, each of which is dated as of February 5, 2005 (except that the Change in Control Severance Agreement between the Company and Thomasin Abuan is dated as of July 27, 2004).

CIC Employees ” shall mean the individuals listed on Annex 10(b) , each of whom is a party to a Change in Control Agreement with the Company.

Closing ” shall mean the consummation of the Merger, as contemplated by Section 1.2 .

Closing Distribution Percentage ” shall mean the amount by which (a) 100%, exceeds (b) the percentage corresponding to a fraction having (i) a numerator equal to the Holdback Amount, and (ii) a denominator equal to the Aggregate Non-Dissenting Residual Amount.

COBRA ” shall mean the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended.

Code ” shall mean the Internal Revenue Code of 1986, as amended.

Company 1020 Product ” shall mean the Company’s proprietary development-stage pharmaceutical product (a) containing the compound aztreonam and designated by the Company as “Corus 1020” and (b) delivered in conjunction with (i) either of the PARI Devices or (ii) any other inhalation device that Gryphon has tested for the delivery of aztreonam (in either case as used in the delivery of such pharmaceutical product).

Company 1040 Product ” shall mean the Company’s proprietary, pre-clinical development-stage pharmaceutical product containing a combination of the compounds fosfomycin and tobramycin, in any combination and formulation.

Company Associate ” shall mean any current or former employee (including any officer), consultant, independent contractor or director of the Company or an ERISA Affiliate.

Company Balance Sheet ” shall mean the Company’s unaudited balance sheet as of the Balance Sheet Date.

Company Benefit Plan ” shall mean any Employee Benefit Plan that is or has been maintained, contributed to or required to be contributed to by the Company or any ERISA Affiliate for the benefit of any Company Associate, or with respect to which the Company or any ERISA Affiliate has or may have any Liability or obligation; provided, however, that a Company Employee Agreement shall not be considered a “Company Benefit Plan.”

Company Bylaws ” shall mean the Amended and Restated Bylaws of the Company dated April 5, 2004.

 

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Company Capital Stock ” shall mean Company Common Stock and Company Preferred Stock.

Company Certificate of Incorporation ” shall mean the Company’s Restated Certificate of Incorporation as in effect on the date of this Agreement.

Company Common Stock ” shall mean the Company’s common stock, par value $0.001 per share.

Company Contract ” shall mean any Contract: (a) to which the Company is a party; (b) by which the Company or any of its Assets is or may become bound or under which the Company has, or may become subject to, any obligation; or (c) under which the Company has or may acquire any right or interest.

Company Employee Agreement ” shall mean any management, employment, severance, change in control, transaction bonus, consulting, relocation, repatriation or expatriation agreement or other Contract between the Company or an ERISA Affiliate and any Company Associate, other than any such Contract that is terminable “at will” by the Company or an ERISA Affiliate without any obligation on the part of the Company or any ERISA Affiliate to make any payment or provide any benefit in connection with the termination of such Contract.

Company Intellectual Property ” shall mean all Intellectual Property Rights and Intellectual Property in which the Company has (or purports to have) an ownership interest or a license, or that is otherwise used or to be used in the business of the Company as currently conducted or as currently proposed to be conducted by the Company.

Company Material Adverse Effect ” shall mean any change, event, effect, claim, violation, inaccuracy, circumstance or other matter (any such item, an “ Effect ”) that, individually or taken together with all other Effects, (a) is or could reasonably be expected to be or to become materially adverse to the business, operations, financial performance, properties, capitalization, condition (financial or otherwise), Intellectual Property, Intellectual Property Rights, Contract rights, employee relations, government relations, Governmental Authorizations, Assets, Liabilities or current drug development plans of the Company or (b) prevents or materially limits or delays, or could reasonably be expected to prevent or materially limit or delay, the performance by the Company of any of its or his obligations, agreements or covenants under this Agreement or any of the other Operative Documents, the exercise by Acquiror of any of its rights under this Agreement or any of the Other Operative Documents or the consummation of the Merger or any of the other transactions contemplated by the Operative Documents; provided, however , that in no event shall any of the following occurring after the date of this Agreement, alone or in combination, be deemed to constitute, or be taken into account in determining whether there has been or will be, a Company Material Adverse Effect: (i) any Effect that results directly from changes affecting the biotechnology or pharmaceutical industries generally (to the extent such Effect is not disproportionate with respect to the Company in any material respect) or the United States economy generally (to the extent such Effect is not disproportionate with respect to the Company in any material respect); or (ii) any Effect that results directly from changes affecting general worldwide economic or capital market conditions (to the extent such Effect is not disproportionate with respect to the Company in any material respect).

 

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Company Option Plan ” shall mean the Company’s 2001 Stock Plan, as amended.

Company Pension Plan ” shall mean any (a) Company Benefit Plan that is an “employee pension benefit plan,” within the meaning of Section 3(2) of ERISA, or (b) other occupational pension plan, including any final salary or money purchase plan.

Company Preferred Stock ” shall mean the Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock.

Company Stock Option ” shall mean an option to acquire shares of Company Capital Stock from the Company, whether vested or unvested, and whether granted under any Company Option Plan or otherwise.

Company Stock Rights ” shall mean any options, warrants, convertible securities, subscriptions, stock appreciation rights, phantom stock plans, stock equivalents, rights of first refusal or offer, preemptive rights or other rights, agreements, arrangements or commitments (contingent or otherwise and whether or not immediately exercisable) of any character issued, granted, authorized or assumed by the Company or by which the Company is bound relating to all or any portion of the issued or unissued capital stock of the Company or obligating the Company to issue or grant, authorize or sell any shares of capital stock of, or options, warrants, convertible securities, subscriptions or other equity interests or similar interests in, the Company.

Company Warrant ” shall mean that certain warrant to acquire 219,725 shares of Company Common Stock held by Corus Pharma Warrant Holdings.

Consent ” shall mean any approval, consent, ratification, permission, waiver or authorization (including any Governmental Authorization).

Contemplated Transactions ” shall mean the transactions and other matters contemplated by this Agreement and the other Operative Documents, including (a) the Merger and the solicitation and obtaining of the adoption of this Agreement pursuant to the Stockholder Consent, and (b) the execution, delivery and performance of the Operative Documents.

Contract ” shall mean any legally binding written, oral or other agreement, contract, subcontract, lease, understanding, arrangement, instrument, note, option, warranty, purchase order, license, sublicense, insurance policy, benefit plan or legally binding commitment or undertaking of any nature.

Countersigned Offer Letters ” shall mean those certain employment offer letters from Acquiror, dated prior to the date of this Agreement and effective as of the Closing, as countersigned by each of the CIC Employees identified as having signed a Countersigned Offer Letter on Annex 10(b), pursuant to which each of such CIC Employees has agreed (i) to accept employment following the Closing with Acquiror or the Surviving Corporation, (ii) to the amendment to the Change in Control Agreement to which such CIC Employee is a party described therein and (iii) to such other matters as are described therein.

 

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Disclosure Memorandum ” shall mean the Disclosure Memorandum delivered by the Company to Acquiror and Merger Sub concurrently with the execution of this Agreement.

Dissenting Holder ” shall mean any Stockholder who has demanded appraisal of his, her or its shares of Company Capital Stock pursuant to Section 262 of the DGCL and as of the Effective Time has neither effectively withdrawn nor lost his, her or its right to appraisal of such shares.

Dissenting Shares ” shall mean any shares of Company Capital Stock held by a Dissenting Holder with respect to which such Dissenting Holder asserts appraisal rights pursuant to Section 262 of the DGCL (and with respect to which such appraisal rights shall not have been lost).

DOL ” shall mean the United States Department of Labor.

Effective Time ” shall mean the time the Certificate of Merger is duly filed with the Delaware Secretary of State, or such other time jointly determined by the Company and Acquiror as is specified in the Certificate of Merger.

Eligible Debt Securities ” shall mean debt securities issued by the Company that (a) are exercisable or convertible solely into shares of Company Capital Stock and (b) are repayable by the Company (without penalty) at any time; provided, however , that notwithstanding the foregoing, the promissory notes evidencing any Pre-Closing Period Loans shall not be considered Eligible Debt Securities hereunder.

Eligible Debt Securities Amount ” shall mean the aggregate face amount of all Eligible Debt Securities, if any, issued by the Company at any time during the Pre-Closing Period.

Employee Benefit Plan ” shall mean any plan, fund, program, agreement, arrangement or scheme providing for employee benefits or for the remuneration, direct or indirect, of any of the current or former employees, directors, officers, consultants, independent contractors, contingent workers or leased employees of any Person or the dependents of any of them (whether written or oral), including each: (a) deferred compensation, bonus, incentive compensation, pension, retirement, stock purchase, stock option and other equity compensation plan; (b) “welfare” plan (within the meaning of Section 3(1) of ERISA, determined without regard to whether such plan is subject to ERISA); (c) “pension” plan (within the meaning of Section 3(2) of ERISA, determined without regard to whether such plan is subject to ERISA); (d) severance plan or agreement; (e) health, vacation, summer hours, supplemental unemployment benefit, hospitalization insurance, medical, dental or legal benefit plan; and (f) other employee benefit plan, fund, program, agreement or arrangement.

Encumbrance ” shall mean any lien, mortgage, pledge, deed of trust, security interest, charge, encumbrance, hypothecation, mortgage, infringement, interference, option, right of first refusal, preemptive right, community property interest or restriction of any nature (including any

 

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restriction on the voting of any security, any restriction on the transfer of any security or other Asset, any restriction on the receipt of any income derived from any Asset, any restriction on the use of any Asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any Asset) or other claim or interest of any kind.

End Date ” shall mean the date 90 days after the commencement of the Secondary Period; provided, however , that in the event that on or prior to such date, (a) a settlement has been entered into in connection with the Specified Litigation that is not a Lump Sum Settlement, or a Final Judgment has been entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment, (b) the Parties have not agreed on the “Lump Sum Equivalent Amount” of such settlement or Final Judgment and (c) the determination of the Lump Sum Equivalent Amount of such settlement or Final Judgment has been submitted to arbitration in accordance with Section 6.3(c) , then (i) the Parties shall use commercially reasonable efforts to cause such arbitration to be completed within thirty (30) days after the date on which such determination has been submitted to arbitration, and (ii) the End Date shall be the date ten (10) Business Days after the date of the final decision in any arbitration conducted in accordance with the principles and procedures set forth on Annex 6.3(c) for the purposes of determining the “Lump Sum Equivalent Amount” of such settlement or Final Judgment.

Enforceability Exceptions ” shall mean (a) applicable bankruptcy and other similar Laws affecting the rights of creditors generally, (b) rules of Law governing specific performance, injunctive relief and other equitable remedies, and (c) the enforceability of provisions requiring indemnification against liabilities under securities Laws in connection with the offering, sale or issuance of securities.

Entity ” shall mean any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), branch office, firm or other enterprise, association, organization or entity, including any Governmental Entity.

Environmental Laws ” shall mean Laws relating to protection of the environment, pollution control, health and safety, product registration or Hazardous Materials, including any Laws relating to emissions, discharges, releases or threatened releases of Hazardous Materials, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials.

ERISA ” shall mean the Employee Retirement Income Security Act of 1974, as amended.

ERISA Affiliate ” shall mean any Person under common control with the Company within the meaning of Sections 414(b), 414(c), 414(m) and 414(o) of the Code, and the regulations thereunder.

Euticals ” shall mean Euticals S.p.A.

Euticals Agreement ” shall mean the Pharmaceutical Supply Agreement between the Company and Euticals dated January 23, 2004.

 

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Final Judgment ” shall mean the last to occur of the following events in the Specified Litigation: (i) the entry by the trial court of order(s) granting summary judgment on all causes of action and the expiration of the time for, and resolution of, any motions for reconsideration on such summary judgment motion; (ii) the entry by the trial court of a judgment with respect to a jury verdict and expiration of the time for the filing of post-verdict motions without any such motions being filed; and (iii) the issuance of all orders, following the entry by the trial court of a judgment with respect to a jury verdict, resolving all post-trial motions, including any post-trial motions for judgment notwithstanding the verdict, judgment as a matter of law, a new trial, injunctive relief, the imposition of a constructive trust or enhanced damages, but specifically excluding any motion for attorneys fees or costs.

Foreign Plan ” shall mean any: (a) Company Benefit Plan mandated by a Governmental Entity outside the United States; (b) Company Benefit Plan that is subject to any of the Laws of any jurisdiction outside the United States; or (c) Company Benefit Plan that covers or has covered any Company Associate whose services are or have been performed primarily outside the United States.

Fully Diluted Company Share Number ” shall mean the sum of (a) the aggregate number of shares of Company Common Stock outstanding immediately prior to the Effective Time (including any such shares that are subject to a repurchase option or risk of forfeiture under any restricted stock purchase agreement or other Contract and including any such shares subject to issuance pursuant to Company Stock Options exercised prior to the Effective Time or pursuant to the exercise of the Company Warrant), (b) the aggregate number of shares of Company Common Stock purchasable under or otherwise subject to Company Stock Options that are outstanding immediately prior to the Effective Time (whether or not such Company Stock Options are immediately exercisable), (c) the aggregate number of shares of Company Common Stock issuable upon the conversion (at the applicable conversion ratio) of all shares of Company Preferred Stock (other than Acquiror-Held Company Securities) outstanding immediately prior to the Effective Time, and (d) the aggregate number of shares of Company Common Stock issuable upon the conversion or exercise of any other convertible securities of the Company or Company Stock Rights outstanding immediately prior to the Effective Time.

GAAP ” shall mean United States generally accepted accounting principles.

Governmental Authorization ” shall mean any permit, license, certificate, franchise, permission, variance, clearance, registration, designation, qualification or authorization issued, granted, given or otherwise made available by or under the authority of any Governmental Entity or pursuant to any Law. A Governmental Authorization shall be deemed to be “required” in connection with the Contemplated Transactions if the failure to obtain such Governmental Authorization could reasonably be expected to have an adverse effect on Acquiror or the Company in the event the Contemplated Transactions were consummated.

Governmental Entity ” shall mean any nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature, any United States federal, state or local, or any foreign, government or any court, tribunal, administrative or regulatory agency, commission, division, department, agency, commission, instrumentality, official, organization, unit, body or other governmental or quasi-governmental authority or agency, domestic or foreign, and any self-regulatory organization (including Nasdaq).

 

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Hazardous Materials ” shall mean any waste, pollutant, hazardous substance, toxic, ignitable, radioactive, reactive or corrosive substance, industrial substance, by-product, process intermediate product or waste, petroleum or petroleum-derived substance or waste, chemical liquids or solids, liquid or gaseous products, or any constituent of any such substance or waste, the use, handling or disposal of which is in any way governed by or subject to any applicable Law.

Holdback Amount ” shall mean the sum of (a) the Primary Holdback Amount plus (b) the Supplemental Holdback Amount.

Holdback Payment ” shall mean any Initial Holdback Payment, Subsequent Holdback Payment or Supplemental Holdback Payment.

Holdback Percentage ” shall mean, with respect to any Non-Dissenting Holder, the percentage corresponding to a fraction having (i) a numerator equal to the portion of the Aggregate Non-Dissenting Residual Amount attributable to shares of Company Capital Stock held by such Non-Dissenting Holder, and (ii) a denominator equal to the Aggregate Non-Dissenting Residual Amount.

HSR Act ” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

Indemnified Parties ” shall mean the following Persons: (a) Acquiror; (b) Acquiror’s current and future Affiliates (including the Surviving Corporation); (c) the respective Representatives of the Persons referred to in clauses “(a)” and “(b)” above; and (d) the respective successors and assigns of the Persons referred to in clauses “(a)”, “(b)” and “(c)” above; provided, however , that the Stockholders shall not be deemed to be “Indemnified Parties.”

Indemnity Claim ” shall mean any claim for indemnification under Article VIII .

Indemnity Claim Notice ” shall mean written notice of any Indemnity Claim.

Intellectual Property ” shall mean information, results and data of any type whatsoever, including databases, data collections, development tools, practices, processes, techniques, methods, specifications, protocols, formulations, formulae, knowledge, know-how, diagrams, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, inventions (whether or not patentable), logos, marks (including brand names, product names, logos and slogans), proprietary information, software and software code (in any form, including source code and executable or object code), works of authorship and other forms of technology, whether or not embodied in any tangible form and including all tangible embodiments of the foregoing, such as instruction manuals, laboratory notebooks, prototypes, samples, specimens, studies and summaries.

 

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Intellectual Property Rights ” shall mean all past and present rights of the following types, which exist or have been created under the Laws of any jurisdiction in the world: (a) rights associated with works of authorship, including exclusive exploitation rights, copyrights and moral rights; (b) trademark and trade name rights and similar rights; (c) trade secret rights; (d) patent and industrial property rights; (e) other proprietary rights in Intellectual Property; and (f) rights in or relating to registrations, renewals, extensions, combinations, divisions and reissues of, and applications for, any of the rights referred to in clauses “(i)” through “(e)” above.

IRS ” shall mean the United States Internal Revenue Service.

knowledge ” shall mean, with respect to an individual, that (a) such individual is actually aware of the fact or other matter in question or (b) any of the Company Associates who directly report to such individual has actual knowledge of the fact or other matter in question. The Company shall be deemed to have “knowledge” of a particular fact or other matter if any of the individuals identified on Annex 10(a) or any members of the Board of Directors of the Company has knowledge of such fact or other matter.

Law ” shall mean any federal, state, local, municipal or foreign statute, law, requirement, Consent, ordinance, policy, rule of common law, constitution, resolution, ordinance, code, edict, decree, rule, regulation, order, award, ruling or interpretation issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity, including any judicial or administrative interpretation thereof.

Legal Proceeding ” shall mean any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), hearing, inquiry, audit, examination or investigation commenced, brought, conducted or heard by or before, or otherwise involving, any court or other Governmental Entity or any arbitrator or arbitration panel.

Letter of Transmittal ” shall mean the letter of transmittal for effecting the surrender of Certificates representing Company Capital Stock contemplated by Section 1.7.3 , substantially in the form attached hereto as Exhibit A .

Liabilities ” shall mean any and all debts, liabilities and obligations of any nature whatsoever, whether accrued or fixed, absolute or contingent, unconditional or conditional, mature or unmatured or determined or determinable, including those arising under any Law, those arising under any Contract and those arising as a result of any act or omission.

Loss ” shall mean any loss, obligation (including any obligation to pay royalties), deficiency, diminution in value, damage (including any consequential damage), claim, injury, Liability, demand, settlement, judgment, award, fine, penalty, tax, fee (including reasonable attorneys’ fees), charge, cost (including costs of investigation and including any opportunity cost) or expense of any nature (including, in the case of a Third-Party Claim, the amount of any settlement entered into with respect thereto, and all reasonable legal fees and other expenses).

 

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Lump Sum Equivalent Amount ” shall mean the amount (with respect to the Specified Litigation) agreed to by Acquiror and the Company or determined by arbitration in accordance with the procedures and principles set forth in Annex 6.3(c) .

Lump Sum Judgment ” shall mean a Final Judgment entered by the court in connection with the Specified Litigation that provides solely for the Company to make a single, lump sum cash payment and imposes no other monetary obligations and no injunctive relief or other equitable remedies on the Company or any of the other defendants in the Specified Litigation (other than minor procedural obligations related to the trial and any appeal thereof).

Lump Sum Settlement ” shall mean a settlement of the Specified Litigation that provides solely for the Company to make a single, lump sum cash payment and imposes no other obligation of any nature on the Company or any of the other defendants in the Specified Litigation.

Made Available ” shall mean that the subject documents were actually delivered by the Company to Acquiror or its counsel prior to the date of this Agreement or were located in the data room organized by the Company at the offices of Orrick, Herrington & Sutcliffe in Menlo Park, California, at all times between August 24, 2005 and October 14, 2005 in connection with the diligence investigation conducted by Acquiror.

Material Contract ” shall mean:

(a) any Contract providing for potential payments by or to the Company in excess of $100,000 or providing for the delivery by or to the Company of consideration valued at more than $100,000;

(b) any Contract (including any Company Employee Agreement) (i) pursuant to which the Company is or may become obligated to make any severance, termination or similar payment to any Company Associate in excess of $100,000, (ii) providing for payment of base salary by the Company to any current employee in excess of $100,000 on an annualized basis or (iii) pursuant to which the Company is or may become obligated to make any bonus or similar payment (whether in the form of cash, stock or other securities, excluding payments constituting base salary and sales commissions) in excess of $25,000 to any Company Associate;

(c) any Contract providing for the acquisition, transfer, development, distribution, promotion, marketing, sharing, support or license of any Intellectual Property or Intellectual Property Right, other than standard form license agreements for commercially available software priced at less than $5,000;

(d) any Contract (i) creating or relating to any partnership or collaboration, or any joint development, joint marketing, distribution or similar arrangement, or (ii) pursuant to which the Company grants or has granted to any Person the right to manufacture, develop or market any product containing aztreonam;

(e) any Contract providing for the manufacture of bulk aztreonam or finished or packaged aztreonam;

 

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(f) any Contract with any clinical research organization (a “CRO Contract”) providing clinical trial services for any clinical trial for any product containing aztreonam;

(g) any Contract that provides for indemnification, or for reimbursement of any legal fees or expenses, of any Company Associate;

(h) any Contract relating to the Specified Litigation that involves greater than $5,000 or that could reasonably be expected to have an adverse effect on the nature or scope of any remedy to be awarded in the Specified Litigation, on the cost of defending the Specified Litigation, on the timing of the resolution of the Specified Litigation or on the prospects for settling the Specified Litigation;

(i) any Contract that would require the consent of any Person in order to consummate any of the Contemplated Transactions;

(j) any Contract imposing any restriction on the right or ability of the Company (i) to compete with, or solicit any customer of, any other Person, (ii) to acquire any product or other Asset or any services from any other Person, (iii) to solicit, hire or retain any Person as an employee, consultant or independent contractor, (iv) to develop, sell, supply, distribute, offer, support or service any product or any technology or other Asset to or for any other Person, (v) to perform services for any other Person, or (vi) to transact business or deal in any other manner with any other Person;

(k) any Contract (other than Contracts evidencing Company Options) (i) relating to the acquisition, issuance, voting, registration, sale or transfer of any securities, (ii) providing any Person with any preemptive right, right of participation, right of maintenance or similar right with respect to any securities, or (iii) providing the Company with any right of first refusal with respect to, or right to repurchase, redeem, put or call, any securities;

(l) any Contract relating to the creation of any Encumbrance with respect to any material Asset of the Company;

(m) any Contract providing for the sharing of revenues, profits, losses, costs, Assets or Liabilities;

(n) any Contract (i) containing “standstill” or similar provisions relating to transactions involving the acquisition, disposition or other transfer of Assets or securities of an Entity, or (ii) providing any right of first negotiation, right of first refusal or similar right to any Person;

(o) any Contract relating to the purchase or sale of any product or other Asset by or to, or the performance of any services by or for, any Related Party;

(p) any Contract (i) contemplating payments or the delivery of other consideration during any 12-month period aggregating or having an aggregate value of more than $100,000, (ii) that has a term of more than 60 days and that may not be terminated by the Company (without penalty) within 60 days after the delivery of a termination notice by the

 

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Company or (iii) under which the Merger or any of the other Contemplated Transactions would give rise to or expand any rights in favor of, or any obligations on the part of, the Company or any other Person;

(q) any Contract that could reasonably be expected to (i) have or result in a material effect on the business, operations, financial performance, properties, capitalization, condition (financial or otherwise), Intellectual Property, Intellectual Property Rights, Contract rights, employee relations, government relations, Governmental Authorizations, Assets, Liabilities or current drug development plans of the Company, or Acquiror’s right to own, or to receive dividends or other distributions with respect to, the stock of the Surviving Corporation or (ii) prevent or materially limit or delay the performance by the Company of any of its obligations, agreements or covenants under this Agreement or any of the Operative Documents, the exercise by Acquiror of any of its rights under this Agreement or any of the Operative Documents or the consummation of the Merger or the other transactions contemplated by any of the Operative Documents;

(r) any Product Contract;

(s) any Contract of a type required to be disclosed by Section 2.3 , other than any Contract providing for the grant of Company Options; and

(t) any other Contract, if a breach of such Contract or the termination of such Contract could reasonably be expected to have or result in a Company Material Adverse Effect.

Non-Dissenting Holder ” shall mean any Stockholder who is not a Dissenting Holder.

Operative Documents ” shall mean this Agreement, the Series C Preferred Stock Purchase Agreement, the Registration Rights Agreement, the Stockholders’ Agreement, the 1040 Product Agreement, the Key Stockholder Agreements, the Noncompetition Agreements, the General Releases, the Countersigned Offer Letters, the Joint Defense Agreement and the Stockholder Consent.

Option Exchange Ratio ” shall mean a fraction, (a) the numerator of which is the Residual Per Share Amount, and (b) the denominator of which is the average closing price of a share of Acquiror Common Stock on the Nasdaq National Market for the period of five consecutive trading days ending on the Closing Date (adjusted as appropriate to reflect any stock split, stock dividend, reverse stock split, reclassification or other similar transaction effected by Acquiror between the beginning of such period and the Closing).

Order ” shall mean any writ, judgment, injunction, consent, order, decree, stipulation, award of or by any Governmental Entity.

PARI ” shall mean PARI GmbH.

PARI Agreement ” shall mean the Development Agreement between PARI and Salus dated February 20, 2002.

 

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PARI Devices ” shall mean (i) the inhalation device currently used in the Company’s Phase 3 clinical trials, and (ii) the modified eFlow inhalation device contemplated by the eKey Agreement between PARI and the Company dated May 18, 2005.

Patent Right ” shall mean any (a) patent or patent application, or (b) continuation, continuation-in-part, divisional, re-examination, extension, reissue or foreign counterpart of any patent or patent application.

Paying Agent ” shall mean a paying agent selected by Acquiror and reasonably acceptable to the Company.

Person ” shall mean any individual or Entity.

Plantex ” shall mean Plantex, Ltd.

Post-Merger Specified Litigation Losses ” shall mean all Losses that are or have been directly or indirectly paid, payable, suffered, borne or incurred by Acquiror, the Surviving Corporation and other Indemnified Parties (or any of them), and all Losses to which Acquiror, the Surviving Corporation and other Indemnified Parties (or any of them) otherwise become subject, that are paid, payable, suffered, borne or incurred after the Effective Time and that directly or indirectly arise from or as a result of, or are directly or indirectly connected with, the Specified Litigation (or any appeal relating to the Specified Litigation), including legal fees and expenses, filing fees, court reporter fees, witness fees, accounting fees and expenses, other advisory fees and expenses, amounts paid or payable in full or partial settlement of the Specified Litigation (including the Lump Sum Equivalent Amount of any settlement entered into in connection with the Specified Litigation that is not a Lump Sum Settlement), amounts paid or payable pursuant to any Order, license agreement, royalty agreement or any other Contract relating to, or entered into in connection with the full or partial settlement of, the Specified Litigation (including the Lump Sum Equivalent Amount of any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment), any amounts paid or payable by or on behalf of Acquiror, the Surviving Corporation or any of the Indemnified Parties to any Company Associate as indemnification or reimbursement of expenses or other amounts paid or payable by such Company Associate in connection with the Specified Litigation, whether or not such Company Associate has actually demanded such amounts during the Survival Period, and any other amounts directly or indirectly paid, payable, suffered or incurred by Acquiror, the Surviving Corporation and other Indemnified Parties at any time after the Effective Time with respect to or in connection with the Specified Litigation; provided, however , that in computing the Post-Merger Specified Litigation Losses, the amount of the Losses associated with any settlement entered into in connection with the Specified Litigation that is not a Lump Sum Settlement, or any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment, shall be the “Lump Sum Equivalent Amount” of such settlement or Final Judgment.

Pre-Closing Indemnity Claim ” shall mean a claim made by Acquiror in an Indemnity Claim Notice delivered at or prior to the Closing that: (a) constitutes or involves an allegation by Parent that there was any inaccuracy in, or breach of, any representation or warranty made by the

 

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Company in this Agreement as of the date of this Agreement, without giving effect to (i) any “Company Material Adverse Effect” or other materiality qualification, or any similar qualification, that is contained or incorporated directly or indirectly in such representation or warranty and that would otherwise limit the scope or effect of such representation or warranty, or (ii) any Disclosure Memorandum Update made or purported to have been made on or after the date of this Agreement; or (b) constitutes or involves an allegation by Parent that there has been any failure by the Company to perform or comply, in whole or in part, with any obligation, agreement or covenant in this Agreement.

Pre-Closing Indemnity Settlement Amount ” shall mean the aggregate amount, if any, agreed in writing by the Parties as a reduction to the Aggregate Transaction Value in consideration of the resolution or settlement of all Settled Pre-Closing Indemnity Claims.

Predecessor Entity ” shall mean Abaris, Salus and Summanus.

Pre-Merger Specified Litigation Loss Amount ” shall mean all Losses that are or have been directly or indirectly paid, payable, suffered, borne or incurred by the Company and other Indemnified Parties (or any of them), and all Losses to which the Company and other Indemnified Parties (or any of them) otherwise become or have become subject, that are paid, payable, suffered, borne or incurred at any time between the date of this Agreement and the Effective Time and that directly or indirectly arise or arose from or as a result of, or are or were directly or indirectly connected with, the Specified Litigation (or any appeal relating to the Specified Litigation), including filing fees, court reporter fees, witness fees, accounting fees and expenses, other advisory fees and expenses, amounts paid or payable in full or partial settlement of the Specified Litigation (including the Lump Sum Equivalent Amount of any settlement entered into in connection with the Specified Litigation that is not a Lump Sum Settlement), amounts paid or payable pursuant to any Order, license agreement, royalty agreement or any other Contract relating to, or entered into in connection with the full or partial settlement of, the Specified Litigation (including the Lump Sum Equivalent Amount of any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment), any amounts paid or payable by or on behalf of the Company or any of the Indemnified Parties to any Company Associate as indemnification or reimbursement of expenses or other amounts paid or payable by such Company Associate in connection with the Specified Litigation, whether or not such Company Associate has actually demanded such amounts prior to the Effective Time, and any other amounts directly or indirectly paid, payable, suffered or incurred by the Company and other Indemnified Parties at any time between the date of this Agreement and the Effective Time with respect to or in connection with the Specified Litigation; provided, however , that (i) the Pre-Merger Specified Litigation Loss Amount shall not include legal fees and expenses actually paid by the Company to its outside legal counsel between the date of this Agreement and the Effective Time for litigation services performed in connection with the Specified Litigation, and (ii) in computing the Pre-Merger Specified Litigation Loss Amount, the amount of the Losses associated with any settlement entered into in connection with the Specified Litigation that is not a Lump Sum Settlement, or any Final Judgment entered by the court in connection with the Specified Litigation that is not a Lump Sum Judgment, shall be the “Lump Sum Equivalent Amount” of such settlement or Final Judgment. For the avoidance of doubt, the amount of any Final Judgment in the Specified Litigation shall be deemed “payable” (and shall be included in the Pre-Merger Specified Litigation Loss Amount) regardless of whether such Final Judgment remains subject to, or eligible for, an appeal.

 

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Primary Holdback Amount ” shall mean $36,500,000.

Registration Rights Agreement ” shall mean that certain Amended and Restated Registration Rights Agreement dated April 9, 2004, among the Company and certain investors in the Company named therein, as amended by Amendment No. 1 thereto dated as of April 12, 2006.

Related Party ” shall mean: (a) each of the Key Stockholders; (b) each individual who is, or who has at any time been, an officer, director or CIC Employee of the Company or any Predecessor Entity; (iii) each member of the immediate family of each of the Persons referred to in clauses “(a)” and “(b)” above; and (d) any trust or other Entity (other than the Company) in which any one of the Persons referred to in clauses “(a)”, “(b)” and “(c)” above holds (or in which more than one of such individuals collectively hold), beneficially or otherwise, a material voting, proprietary or equity interest.

Representatives ” shall mean officers, directors, employees, partners, accountants, auditors, attorneys, advisors, representatives and other agents.

Residual Per Share Amount ” shall mean the amount determined by dividing (a) the amount by which (i) the sum of the Aggregate Closing Transaction Value plus the Aggregate Exercise Amount exceeds (ii) the Aggregate Preference Amount by (b) the Fully Diluted Company Share Number.

Salus ” shall mean the company formerly known as Salus Pharma, Inc., which was merged into the Company on January 1, 2004.

Series A Preference Amount ” shall mean $2.1845 (subject to adjustment as appropriate to reflect any stock split, reverse stock split, stock dividend, recapitalization or other similar transaction effected by the Company with respect to the Series A Preferred Stock prior to the Effective Time).

Series B Preference Amount ” shall mean $0.9729 (subject to adjustment as appropriate to reflect any stock split, reverse stock split, stock dividend, recapitalization or other similar transaction effected by the Company with respect to the Series B Preferred Stock prior to the Effective Time).

Series C Preference Amount ” shall mean $1.16 (subject to adjustment as appropriate to reflect any stock split, reverse stock split, stock dividend, recapitalization or other similar transaction effected by the Company with respect to the Series C Preferred Stock prior to the Effective Time).

Series A Preferred Stock ” shall mean the Company’s Series A Preferred Stock, $0.001 par value per share.

 

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Series B Preferred Stock ” shall mean the Company’s Series B Preferred Stock, $0.001 par value per share.

Series C Preferred Stock ” shall mean the Company’s Series C Preferred Stock, $0.001 par value per share.

Settled Pre-Closing Indemnity Claims ” shall mean Pre-Closing Indemnity Claims that are settled or otherwise resolved between Acquiror and the Company at or prior to the Closing.

Specified Litigation ” shall mean that certain Legal Proceeding entitled “Chiron Corporation, Plaintiff, v. Corus Pharma, Inc., Salus Pharma, Inc., Alan Bruce Montgomery and William Baker, Defendants, Case No. 04-2-35883-SEA in the Superior Court of the State of Washington, for the County of King” and any appeal thereof or related pending, threatened or potential Legal Proceeding involving (a) the Company or any of its products or any Company Associate, and (b) Chiron Corporation or any of its Affiliates (other than any related Legal Proceeding in which one or more Company Associates (but not the Company) is a plaintiff).

Specified Litigation Document ” shall mean any document, record, written material or other information in written or readable form that relates to, or contains any analysis or discussion of, the Specified Litigation.

Specified Transaction ” shall mean any of the following: (a) any merger, consolidation, share exchange, business combination, reorganization, recapitalization or similar transaction involving the Company; (b) any sale, lease, license, exchange, transfer or other disposition of a material portion of the Assets of, or an equity, voting, beneficial or other interest in, the Company; (c) any tender offer or exchange offer for all or any portion of the outstanding securities of the Company; (d) any sale, issuance, grant or disposition of any option, call, warrant or right (whether or not immediately exercisable) to acquire, or any security, instrument or obligation that is or may become convertible into or exchangeable for, five percent or more of the outstanding voting or equity securities of the Company; (e) any partnership, alliance or joint venture involving the Company or any of its products; (f) any borrowing or debt financing involving the Company; or (g) any solicitation in opposition to adoption by the Stockholders of this Agreement or the approval by the Stockholders of the Merger.

Stockholder Consent ” shall mean the written consent of the Stockholders contemplated by Section 6.11 .

Stockholder Representative Committee ” shall mean a committee of three representatives of the Non-Dissenting Holders, to be elected by the Non-Dissenting Holders.

Stockholders ” shall mean holders of Company Capital Stock.

Stockholders’ Agreement ” shall mean that certain Amended and Restated Stockholders’ Agreement dated as of April 12, 2006, among the Company and certain stockholders of the Company named therein.

 

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Subsidiary ” of any Person shall mean any Entity of which such Person (either directly or through or together with another Subsidiary of such Person) owns (a) more than 50% of the voting stock, equity interests or value of such Entity, or (b) an amount of voting securities or other interests in such Entity that is sufficient to enable such Person to elect at least a majority of the members of such Entity’s board of directors or other governing body.

Summanus ” shall mean the company formerly known as Summanus Pharma, Inc., which was merged into the Company on January 1, 2004.

Supplemental Holdback Amount ” shall mean the amount (if any) by which (i) the lesser of (A) $13,500,000 or (B) the aggregate total of all Claimed Amounts set forth in Indemnity Claim Notices delivered by Acquiror to the Company during the Pre-Closing Period with respect to Pre-Closing Indemnity Claims, exceeds (ii) the Pre-Closing Indemnity Settlement Amount; provided, however , that notwithstanding the foregoing, in the event that the aggregate total of all Claimed Amounts set forth in Indemnity Claim Notices delivered by Acquiror to the Company during the Pre-Closing Period with respect to Pre-Closing Indemnity Claims is less than $500,000, “Supplemental Holdback Amount” shall mean $0.

Tax ” shall mean any federal, state, local or foreign income, gross receipts, property, sales, use, license, excise, franchise, employment, payroll, premium, withholding, alternative or added minimum, ad valorem, transfer or excise tax, or any other tax, custom, duty or other tax, like assessment or charge of any kind whatsoever in the nature of a tax, together with any interest or penalty or addition thereto, whether disputed or not, imposed by any Governmental Entity.

Tax Return ” shall mean any return (including any information return), report, statement, declaration, estimate, schedule, notice, notification, form, election, certificate or other document or information, and any amendment to any of the foregoing, filed with or submitted to, or required to be filed with or submitted to, any Governmental Entity in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Law relating to any Tax.

Teva ” shall mean Teva Pharmaceutical Industries Ltd.

Third-Party Claim ” shall mean any claim or Legal Proceeding asserted or commenced by a third party against an Indemnified Party for which indemnification is available under Article VIII .

 

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IN WITNESS WHEREOF, the Parties have entered into and signed this Agreement and Plan of Merger as of the date and year first above written.

 

GILEAD SCIENCES, INC.
By  

/s/ John F. Milligan

Name   John F. Milligan, Ph.D.
Its   Executive Vice President and Chief Financial Officer
GRYPHON ACQUISITION SUB, INC.
By  

/s/ Gregg H. Alton

Name   Gregg H. Alton
Its   President
CORUS PHARMA, INC.
By  

/s/ A. Bruce Montgomery

Name   A. Bruce Montgomery
Its   Chief Executive Officer

/s/ Rodney A. Ferguson

Rodney A. Ferguson, Ph.D., as Chairman of and on Behalf of the Stockholder Representative Committee

[Signature Page to Agreement and Plan of Merger]

Exhibit 31.1

CERTIFICATION

I, John C. Martin, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Gilead Sciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 3, 2006  

/s/ John C. Martin

 

John C. Martin

President and Chief Executive Officer

 

42

Exhibit 31.2

CERTIFICATION

I, John F. Milligan, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Gilead Sciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 3, 2006  

/s/ John F. Milligan

  John F. Milligan, Ph.D.
  Executive Vice President and Chief Financial Officer

 

43

Exhibit 32

CERTIFICATION

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. § 1350, as adopted), John C. Martin, the Chief Executive Officer of Gilead Sciences, Inc. (the Company), and John F. Milligan, the Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

1. The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2006, to which this Certification is attached as Exhibit 32 (the Periodic Report), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the periods covered by the Periodic Report and results of operations of the Company for the periods covered by the Periodic Report.

Dated: November 3, 2006

 

/s/ John C. Martin

  

/s/ John F. Milligan

John C. Martin    John F. Milligan, Ph.D.
Chief Executive Officer    Chief Financial Officer

 

44