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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 period ended March 31, 2001

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
(State or other jurisdiction of incorporation or organization)
  94-3047598
(I.R.S. Employer Identification No.)

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

 

94404
(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 / /

    Number of shares outstanding of the issuer's common stock, par value $.001 per share, as of April 30, 2001: 94,696,787





GILEAD SCIENCES, INC.

INDEX

 
   
  Page No.
PART I. FINANCIAL INFORMATION    
 
Item 1.

 

Condensed Consolidated Financial Statements:

 

 

 

 

Condensed Consolidated Balance Sheets at March 31, 2001 and December 31, 2000

 

3

 

 

Condensed Consolidated Statements of Operations For the three months ended March 31, 2001 and 2000

 

4

 

 

Condensed Consolidated Statements of Cash Flows For the three months ended March 31, 2001 and 2000

 

5

 

 

Notes to Condensed Consolidated Financial Statements

 

6
 
Item 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

10
 
Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

15

PART II.

 

OTHER INFORMATION

 

 
 
Item 4.

 

Submission of Matters to a Vote of Securities Holders

 

16
 
Item 5.

 

Other Matters

 

16
 
Item 6.

 

Exhibits and Reports on Form 8-K

 

16

SIGNATURES

 

17

2



PART I. FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS


GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)

 
  March 31,
2001

  December 31,
2000

 
 
  (unaudited)

  (Note)

 
Assets              
Current assets:              
  Cash and cash equivalents   $ 77,403   $ 197,292  
  Marketable securities     406,407     315,586  
  Accounts receivable     51,187     48,814  
  Inventories     20,537     20,562  
  Prepaid expenses and other     14,844     11,544  
   
 
 
    Total current assets     570,378     593,798  
Property, plant and equipment, net     54,975     55,174  
Other noncurrent assets     32,192     29,127  
   
 
 
    $ 657,545   $ 678,099  
   
 
 
Liabilities and stockholders' equity              
Current liabilities:              
  Accounts payable   $ 9,908   $ 11,605  
  Accrued clinical and preclinical expenses     11,010     9,925  
  Accrued compensation and employee benefits     9,908     9,995  
  Other accrued liabilities     18,608     19,324  
  Deferred revenue     2,914     4,355  
  Long-term obligations due within one year     2,854     3,034  
   
 
 
    Total current liabilities     55,202     58,238  

Long-term deferred revenue

 

 

10,578

 

 

10,730

 
Accrued litigation settlement expenses     5,484     5,769  
Long-term obligations due after one year     1,941     2,238  
Convertible subordinated notes     250,000     250,000  

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 
  Common stock, par value $.001 per share; 500,000,000 shares authorized; shares issued and outstanding: 94,451,768 shares at March 31, 2001 and 94,287,602 shares at December 31, 2000     94     94  
  Additional paid-in capital     859,572     857,942  
  Accumulated other comprehensive income (loss)     2,405     (901 )
  Deferred compensation     (2 )   (3 )
  Accumulated deficit     (527,729 )   (506,008 )
   
 
 
    Total stockholders' equity     334,340     351,124  
   
 
 
    $ 657,545   $ 678,099  
   
 
 

Note:  The condensed consolidated balance sheet at December 31, 2000 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

See accompanying notes.

3



GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)

 
  Three Months Ended
March 31,

 
 
  2001
  2000
 
Revenues:              
  Product sales, net   $ 45,064   $ 36,340  
  Royalty revenue, net     6,182     8,042  
  Contract revenue     6,437     840  
  Contract revenue—SAB 101     153     2,490  
   
 
 
    Total Revenues     57,836     47,712  

Costs and expenses:

 

 

 

 

 

 

 
  Cost of products sold     10,581     7,947  
  Research and development     51,146     26,246  
  Selling, general and administrative     21,911     17,970  
   
 
 
    Total costs and expenses     83,638     52,163  
   
 
 
    Loss from operations     (25,802 )   (4,451 )

Interest income

 

 

7,383

 

 

3,945

 
Interest expense     (3,533 )   (1,537 )
   
 
 
Loss before provision for income taxes, equity in loss of unconsolidated affiliate and cumulative effect of change in accounting principle     (21,952 )   (2,043 )

Provision for income taxes

 

 

470

 

 

307

 
Equity in loss of unconsolidated affiliate     390     921  
   
 
 
Loss before cumulative effect of change in accounting principle     (22,812 )   (3,271 )
Cumulative effect of change in accounting principle     1,089     (13,670 )
   
 
 
    Net loss   $ (21,723 ) $ (16,941 )
   
 
 
Basic and diluted net loss per common share:              
  Loss before cumulative effect of change in accounting principle   $ (0.24 ) $ (0.04 )
  Cumulative effect of change in accounting principle     0.01     (0.15 )
   
 
 
    Net loss   $ (0.23 ) $ (0.19 )
   
 
 
Common shares used to calculate basic and diluted net loss per common share     94,349     88,680  
   
 
 

See accompanying notes.

4


GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)

 
  Three Months Ended
March 31,

 
 
  2001
  2000
 
OPERATING ACTIVITIES:              
Net loss   $ (21,723 ) $ (16,941 )
  Adjustments to reconcile net loss to net cash used in operating activities:              
    Net effect of change in accounting principle     (1,089 )   11,180  
    Depreciation and amortization     3,445     2,893  
    Equity in loss of unconsolidated affiliate     390     921  
    Net unrealized loss on foreign currency transactions     1,135     1,211  
    Other non-cash transactions     83     94  
    Changes in assets and liabilities:              
      Accounts receivable     (6,030 )   (2,439 )
      Inventories     25     (27 )
      Prepaid expenses and other assets     (3,436 )   2,926  
      Accounts payable     (1,600 )   (2,868 )
      Accrued liabilities     145     (3,241 )
      Deferred revenue (excluding net effect of change in accounting principle)     (1,593 )   732  
   
 
 
Net cash used in operating activities     (30,248 )   (5,559 )

INVESTING ACTIVITIES:

 

 

 

 

 

 

 
  Purchases of marketable securities     (157,796 )   (59,657 )
  Sales of marketable securities     34,592     5,990  
  Maturities of marketable securities     35,456     46,278  
  Capital expenditures     (3,254 )   (3,724 )
  Investment in unconsolidated affiliate         (2,450 )
   
 
 
Net cash used in investing activities     (91,002 )   (13,563 )

FINANCING ACTIVITIES:

 

 

 

 

 

 

 
  Proceeds from issuances of common stock     1,900     9,996  
  Repayments of long-term debt     (477 )   (913 )
   
 
 
Net cash provided by financing activities     1,423     9,083  

Effect of exchange rate on cash

 

 

(62

)

 

324

 
   
 
 
Net decrease in cash and cash equivalents     (119,889 )   (9,715 )
Cash and cash equivalents at beginning of period     197,292     47,011  
   
 
 
Cash and cash equivalents at end of period   $ 77,403   $ 37,296  
   
 
 

NON-CASH ACTIVITIES:

 

 

 

 

 

 

 
Common stock issued upon the conversion of convertible subordinated notes   $   $ 25  
   
 
 

See accompanying notes.

5



GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2001
(unaudited)

1. Summary of Significant Accounting Policies

Basis of Presentation

    The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with 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 is necessary for fair presentation of the balances and results for the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year.

    Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Examples include provisions for sales returns, bad debts and accrued clinical and preclinical expenses. Actual results may differ from these estimates. The accompanying consolidated financial statements include the accounts of the Company and its wholly and majority-owned subsidiaries. Significant intercompany transactions have been eliminated. Certain prior period amounts have been reclassified to conform to the current presentation. The accompanying financial information should be read in conjunction with the audited financial statements for the fiscal year ended December 31, 2000 included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC").

Basic and Diluted Net Loss Per Common Share

    For all periods presented, both basic and diluted net loss per common share are computed by dividing the net loss by the number of weighted average common shares outstanding during the period. Stock options, warrants and convertible subordinated notes could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per common share as their effect is antidilutive for the periods presented. All share and per share amounts for all periods presented have been restated to reflect the two-for-one stock split, effected in the form of a 100% stock dividend, completed on February 22, 2001.

2.  Cumulative Changes in Accounting Principles

    Gilead adopted Statement of Financial Accounting Standards Nos. 133 and 138, collectively referred to as SFAS 133, Accounting for Derivative Instruments and Hedging Activities, in the first quarter of 2001. The change was accounted for as the cumulative effect of a change in accounting principle. See Note 3, "Derivative Financial Instruments." Effective in the first quarter of 2000, Gilead adopted the SEC's Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, and the change was also accounted for as the cumulative effect of a change in accounting principle.

3.  Derivative Financial Instruments

    On January 1, 2001, Gilead adopted SFAS 133, Accounting for Derivative Instruments and Hedging Activities. The standards require that Gilead recognize all derivatives as either assets or liabilities measured at fair value. If the derivative is designated as, and meets the definition of, a fair value hedge, the changes in the fair value of the derivative and of the hedged item attributable to the hedged risk are recognized in earnings. If the derivative is designated as, and meets the definition of, a cash flow hedge, the effective portions of changes in the fair value of the derivative are recorded in other comprehensive income ("OCI") and are recognized in the income statement when the hedged item

6


affects earnings. Ineffective portions of changes in the fair value of cash flow hedges are recognized in earnings immediately. SFAS 133 also requires that warrants to purchase capital stock of a non-public company, which include a net exercise feature, are to be recorded in the balance sheet at fair value with an offsetting amount recorded in the results of operations. The fair value of the warrants are required to be remeasured at each balance sheet date, with changes in the fair value of the warrants recorded in results of operations.

    Gilead has forward currency contracts with maturities of 12 months or less related to its foreign currency denominated accounts receivable and to its forecasted future foreign currency denominated raw material purchases. These forward currency contracts have been designated as and qualify as cash flow hedges. These derivative instruments are employed to eliminate or minimize certain foreign currency exposures that can be confidently identified and quantified. In accordance with SFAS 133, hedges related to unrecognized firm commitments and forecasted foreign currency cash flows associated with accounts receivable are designated and documented at the inception of the respective hedge as cash flow hedges and evaluated for effectiveness quarterly. As the terms of the forward contract and the underlying transaction are matched at inception, forward contract effectiveness is calculated by comparing the fair value of the contract to the change in the forward value of the underlying hedged item, with the effective portion of the gain or loss on the derivative instrument reported as a component of OCI in stockholders' equity and reclassified into earnings in the same period or periods during which the hedged transaction affects earnings. All values reported in OCI will be reclassified to earnings within 12 months. Any residual change in fair value of the instruments or other ineffectiveness is recognized immediately in selling, general and administrative expense. Ineffectiveness in the first quarter of 2001 was not significant. Additionally, Gilead has a warrant to purchase stock in a non-public company. This warrant has a net exercise feature and accordingly, is considered a derivative instrument under SFAS 133.

    Upon adoption of SFAS 133 on January 1, 2001, Gilead recognized an increase in other assets of approximately $1.7 million representing $1.1 million in the fair value of a warrant and $0.6 million for the unrealized gain on forward hedge contracts along with an increase in OCI of $0.6 million. In addition, Gilead recognized an aggregate credit to the results of operations recorded as a cumulative change in accounting principle of $1.1 million representing the fair market value of the warrant.

    During the three months ended March 31, 2001, a $0.4 million loss on hedging contracts had been recognized in the income statement and a $0.6 million reduction in the fair value of derivatives was recognized in OCI. At March 31, 2001, fair value gains and losses on the balance sheet were not material.

4.  Inventories

    Inventories are summarized as follows (in thousands):

 
  March 31, 2001
  December 31, 2000
Raw materials   $ 9,866   $ 9,647
Work in process     4,113     7,781
Finished goods     6,558     3,134
   
 
  Total inventories   $ 20,537   $ 20,562
   
 

5.  Collaborative Arrangements and Contracts

    In January 2001, Gilead entered into an agreement with Cubist Pharmaceuticals, Inc. ("Cubist") relating to Cubist's antibacterial compound daptomycin, including Cidecin™, an intravenous formulation of the compound that is currently in Phase III clinical trials for treatment of bacterial infections. Under

7


the terms of the agreement, Gilead paid Cubist an upfront license fee of $13.0 million and received exclusive commercial rights to the compound in sixteen European countries ("Gilead's territory") as well as the right to develop the compound for commercialization in this territory. Research and development expense has been charged for $10.6 million of the $13.0 million payment. The $2.4 million balance is included in Other noncurrent assets because if, prior to January 2002, Gilead terminates its rights under the agreement with respect to a preclinical oral formulation of daptomycin being developed by Cubist, or if Cubist discontinues development of that oral formulation, Gilead would be entitled to receive a refund of this amount from Cubist. Subsequent to January 2002, this refundable amount is reduced ratably on a monthly basis over a four year period and will be amortized to research and development expense. Cubist will continue to be responsible for worldwide clinical development of Cidecin and the preclinical oral formulation. Gilead will be responsible for both regulatory filings and marketing and selling of the product within Gilead's territory. Gilead may make additional payments to Cubist of up to $31.0 million if certain clinical and regulatory milestones related to Cidecin and the oral formulation are reached. In April 2001, one of these milestones had been met and Gilead agreed to pay the $1.25 million related to that milestone. Additionally, if Cidecin is successfully commercialized in Gilead's territory, Gilead will pay Cubist a royalty on net sales of the product.

6.  Comprehensive Loss

    Following are the components of comprehensive loss (in thousands):

 
  Three months ended
March 31,

 
 
  2001
  2000
 
Net loss   $ (21,723 ) $ (16,941 )
Net foreign currency translation gain (loss)     282     (196 )
Net unrealized gain (loss) on available-for-sale securities     3,073     (276 )
Net unrealized loss on cash flow hedges     (49 )    
   
 
 
  Comprehensive loss   $ (18,417 ) $ (17,413 )
   
 
 

7.  Disclosures about Segments of an Enterprise and Related Information

    The Company has determined that it has only one reportable segment because management has organized the business around its functional lines.

    Product sales consisted of the following (in thousands):

 
  Three months ended
March 31,

 
  2001
  2000
AmBisome®   $ 41,901   $ 34,586
Other     3,163     1,754
   
 
  Consolidated total   $ 45,064   $ 36,340
   
 

8


    The following table summarizes total revenues from external customers and collaborative partners by geographic region. Revenues are attributed to countries based on the location of Gilead's customer or collaborative partner (in thousands).

 
  Three months ended
March 31,

 
  2001
  2000
United States   $ 12,735   $ 6,566
United Kingdom     7,743     5,843
Germany     4,768     5,393
Switzerland     4,500     6,716
Italy     4,534     4,348
Spain     4,536     3,577
Other European countries     14,769     10,178
Other countries     4,251     5,091
   
 
Consolidated total   $ 57,836   $ 47,712
   
 

    Product sales to one distributor accounted for approximately 13% of total revenues for the first three months of 2001 and approximately 12% of total revenues for the same period of 2000. For the quarter ended March 31, 2001, sales to and royalties from Fujisawa Healthcare, Inc. ("Fujisawa") were 15% of total revenue. Revenues from Fujisawa were less than 10% of sales during the first three months of 2000.

8.  Increase in Authorized Shares of Common Stock

    On February 2, 2001, at a special meeting of stockholders, the stockholders approved an amendment to Gilead's certificate of incorporation to increase the number of authorized shares of common stock from 100,000,000 to 500,000,000.

9



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

Overview

    Gilead was incorporated in Delaware on June 22, 1987, and is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. We discover, develop, manufacture and commercialize proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial diseases) and cancer. We also have expertise in liposomal drug delivery technology. Currently, we market AmBisome® ((amphotericin B) liposome for injection), an antifungal agent; DaunoXome® (daunorubicin citrate liposome injection), a drug approved for the treatment of Kaposi's Sarcoma; and VISTIDE® (cidofovir injection) for the treatment of cytomegalovirus retinitis. Hoffmann-La Roche Inc. ("Roche") markets Tamiflu™ (oseltamivir phosphate), a product we co-developed with Roche, for the treatment and prevention of influenza, under a collaborative agreement with us. In addition, we are developing products to treat diseases caused by human immunodeficiency virus ("HIV"), hepatitis B virus ("HBV"), bacterial infections and cancer.

    Gilead completed a two-for-one stock split, effected in the form of a 100% stock dividend, on February 22, 2001. Accordingly, all share and per share amounts for all periods presented have been restated to retroactively reflect the split.

    In the quarter ended March 31, 2001, Gilead adopted SFAS 133, Accounting for Derivative Instruments and Hedging Activities, which resulted in a cumulative effect of change in accounting principle.

    Certain prior period amounts have been reclassified to conform to the current presentation.

Forward-Looking Statements and Risk Factors

    The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in any forward-looking statements. Some of the factors that could cause or contribute to these differences are listed below. You should also read the "Risk Factors" included in our Annual Report on Form 10-K for the year ended December 31, 2000 for more detailed information regarding these and other risks and uncertainties that can affect our actual financial and operating results. All forward-looking statements are based on information currently available to Gilead, and we assume no obligation to update any such forward-looking statements.

    AmBisome Sales.  We rely on sales of AmBisome for a significant portion of our operating income. There are lower priced products that compete with AmBisome; a product that was recently approved that will compete with AmBisome; and products being developed that could compete with AmBisome in the future. If these other products achieve further market acceptance, or if the products in development become commercially available, revenues from sales of AmBisome would likely decrease, resulting in a reduction of operating income.

    Regulatory Process.  The U.S. Food and Drug Administration and foreign agencies could reject or limit the commercialization of our products for a number of reasons including: if they disagree with the results or designs of our clinical trials; if they believe our products have unacceptable efficacy, toxicity or tolerability; or if they believe our products can not be safely and efficiently manufactured on a commercial basis. If these agencies reject or limit the commercialization of our products, our financial results would be adversely affected. The clinical trials required for regulatory approval of our products are extremely expensive, and it is difficult for us to accurately predict or control the amount or timing of these expenses from quarter to quarter. In addition, regulatory agencies could require us to conduct additional unanticipated clinical trials on our products, the cost of which could be substantial.

10


    Market Acceptance of Products.  The ability of our products to achieve and sustain market acceptance will depend on a number of factors, including: the receipt and scope of regulatory approvals; the availability of public and private insurance and reimbursement for our products; safety, efficacy, tolerability and cost of our products; and how our products compare to competitive products. If our products do not achieve and sustain market acceptance, our results of operations will suffer. Tamiflu is in a new class of drugs that represent a new approach to treating and preventing the flu. In order for Tamiflu to achieve market acceptance, our marketing partner, Roche, must change attitudes toward the treatment and prevention of influenza.

    Collaborations.  We depend on collaborations for the development and commercialization of certain products and for revenue, including the collaboration with Roche for sales of Tamiflu worldwide, and the collaboration with Fujisawa for sales of AmBisome in the United States and Canada. These collaborations could fail for a number of reasons, including if our partners do not devote sufficient resources to the development, commercialization or marketing of our products, or if disputes arise with our partners. We will also seek additional collaborations. If our collaborations fail or if we are unable to establish additional collaborations, our financial results would be adversely affected.

    Foreign Currency Fluctuations.  A significant majority of our product sales is denominated in foreign currencies. Increases in the value of the U.S. Dollar against these foreign currencies in the past have reduced, and in the future may reduce, our U.S. Dollar return on these sales and negatively impact our financial condition. We do not hedge our exposure to the impact of fluctuating foreign exchange rates on forecasted sales. We do hedge accounts receivable balances denominated in foreign currencies, which minimizes but does not eliminate our exposure to currency fluctuations between the date a sale is recorded and the date that cash is collected.

    Uncertain Financial Results.  We expect that our financial results will continue to fluctuate from quarter to quarter and that such fluctuations may be substantial. The fluctuations can be caused by many factors that are beyond our control, including the risk factors listed above. We have never been profitable on a full-year basis and we may never achieve or sustain profitability. As of March 31, 2001, our accumulated deficit was $527.7 million.

Results of Operations

Revenues

    We had total revenue of $57.8 million for the quarter ended March 31, 2001 compared with $47.7 million for the quarter ended March 31, 2000. Included in total revenue are net product sales, royalty income and contract revenue, including research and development collaborations.

    Net product sales were $45.1 million for the first quarter of 2001 compared with $36.3 million for the first quarter of 2000. Sales of AmBisome accounted for 93% of revenues from product sales in the first quarter of 2001 and 95% in the first quarter of 2000. Sales of AmBisome for the first quarter of 2001 increased 21% over the first quarter of 2000. Excluding the impact of the decline in foreign currencies relative to the U.S. Dollar in 2001, sales of AmBisome would have increased 29% in the first quarter of 2001 over the comparable period in 2000. In addition, Gilead recorded product sales of $2.1 million and $1.0 million from the sale of VISTIDE and DaunoXome, respectively, during the first quarter of 2001. A significant majority of Gilead's product sales is denominated in foreign currencies. We do not hedge our exposure to the impact of fluctuating foreign exchange rates on forecasted sales. We do hedge accounts receivable balances denominated in foreign currencies, which minimizes but does not eliminate our exposure to currency fluctuations between the date a sale is recorded and the date that cash is collected.

    Net royalty revenue was $6.2 million for the first quarter of 2001 compared with $8.0 million for the comparable quarter in 2000. Royalties in the first quarter of 2001 included $3.8 million from

11


Fujisawa for sales of AmBisome in the United States, $2.1 million from Roche for sales of Tamiflu worldwide and $0.3 million for VISTIDE sales by Pharmacia Corporation ("Pharmacia") outside the United States. First quarter 2000 royalties included $5.4 million from Roche for Tamiflu, $2.2 million from Fujisawa for AmBisome and $0.4 million for VISTIDE sales by Pharmacia. Higher sales of AmBisome in the United States resulted in the $1.6 million increase in Fujisawa royalty payments. We record royalties from Roche in the quarter following the quarter in which the related Tamiflu sales occur. The $3.3 million decline in Tamiflu royalties resulted from the 2000-2001 flu season being the lightest in terms of the number of reported cases in at least six years.

    Total contract revenue was $6.4 million for the quarter ended March 31, 2001 and $0.8 million for the comparable quarter in 2000. Contract revenue for the first quarter of 2001 included a $2.0 million milestone payment from Roche, $2.5 million from marketing agreements, and recognition of $1.7 million of the up-front license fee received from EyeTech Pharmaceuticals, Inc. ("EyeTech") in March 2000. Contract revenue in the first quarter of 2000 included $0.4 million for development expense reimbursements from Roche.

    Additionally, first quarter 2001 contract revenue included $0.2 million related to a previously recognized initial license fee from Pharmacia that was deferred upon adoption of SAB 101 in January 2000 and will be recognized on a straight-line basis over the next twelve years. Included in contract revenue for the first quarter of 2000 was $2.5 million related to previously recognized initial license fees received from Sumitomo Pharmaceuticals Co., Ltd., Roche and Pharmacia. The up-front fees were deferred upon adoption of SAB 101, and $2.5 million is the portion of the fees that was subsequently recognized in contract revenue in the first quarter of 2000.

Cost of Product Sales

    Cost of products sold was $10.6 million, or 23% of net product sales, for the quarter ended March 31, 2001, and $7.9 million, or 22% of net product sales, for the quarter ended March 31, 2000. In connection with most of our European product sales, we price our products in the currency of the country into which the products are sold. A significant majority of our manufacturing cost is in U.S. Dollars. A decline in the value of these foreign currencies relative to the U.S. Dollar will negatively impact gross margins since our manufacturing costs will remain approximately the same while our revenues, which are reported in U.S. Dollars, will decline. In addition, we increased our sales of AmBisome sales to Fujisawa. Under the terms of our agreement with Fujisawa, Gilead supplies AmBisome at manufacturing cost.

    Except for the potential impact of unpredictable and uncontrollable changes in payment currencies relative to the U.S. Dollar and the impact of direct sales to Fujisawa, we expect that cost of sales as a percentage of sales revenues for the full year 2001 to be materially consistent with the 22% amount reported for the year 2000. In future periods, changes in the nature or mix of our product sales could impact this relationship.

Operating Expenses

    Research and development ("R&D") expenses were $51.1 million for the first quarter of 2001, up 95% from $26.2 million for the first quarter of 2000. R&D expenses included for the first quarter of 2001 $10.6 million of the $13.0 million upfront license fee paid to Cubist for daptomycin. In addition, Gilead's expenses associated with the Phase III clinical programs for tenofovir DF for HIV and adefovir dipivoxil for HBV increased significantly during the quarter, including the initiation of an early access program and clinical supply costs for tenofovir DF. We expect R&D expenses for the full year 2001 to be approximately 20% to 30% higher than 2000 levels due to increased spending on the continued late stage development of tenofovir DF for HIV and adefovir dipivoxil for HBV as well as the up-front daptomycin license fee.

12


    Selling, general and administrative ("SG&A") expenses were $21.9 million for the first quarter of 2001, compared to $18.0 million for the first quarter of 2000. The increase was due to sales and marketing and related activities necessary to prepare for the anticipated U.S. and European commercial launch of tenofovir DF. We expect SG&A expenses for the year 2001 to be approximately 25% to 40% higher than 2000 levels due primarily to commercialization expenses related to tenofovir DF.

Interest Income and Interest Expense

    We reported interest income of $7.4 million for the quarter ended March 31, 2001, up from $3.9 million for the quarter ended March 31, 2000. The increase is primarily due to significantly higher investment balances in 2001. At March 31, 2001, we had cash, cash equivalents and marketable securities of $483.8 million, up from $291.8 million at March 31, 2000.

    Interest expense was $3.5 million for the quarter ended March 31, 2001, up from $1.5 million for the quarter ended March 31, 2000. The largest component of interest expense in the first quarter of 2001 was interest on our $250.0 million 5% convertible subordinated notes issued in December 2000. Interest expense for the first quarter of 2000 was principally the interest on the $79.5 million outstanding balance of 6.25% subordinated debentures, which were subsequently converted to common stock in August 2000.

Equity in Loss of Unconsolidated Affiliate

    For the first quarter of 2001, we recorded $0.4 million as our equity in the loss of Proligo L.L.C. ("Proligo"), representing our 49% share of Proligo's losses for its fiscal quarter ended March 31, 2001. For the first quarter of 2000, we recorded equity losses of Proligo of $0.9 million representing our portion of Proligo's loss for its first fiscal quarter ended February 29, 2000. During the fourth quarter of 2000, Proligo changed its fiscal year-end to December 31 from November 30. Our investment in Proligo is reported in other noncurrent assets on the balance sheet, and was $6.6 million at March 31, 2001. We have no commitments to provide additional funding to Proligo.

Liquidity and Capital Resources

    Cash, cash equivalents and marketable securities totaled $483.8 million at March 31, 2001, down from $512.9 million at December 31, 2000. Cash was used primarily to fund operating activities.

    Our accounts receivable balance at March 31, 2001 was $51.2 million compared to a balance of $48.8 million at December 31, 2000. The $2.4 million growth in accounts receivable is due primarily to an increase in net product sales. In certain countries where payments are typically slow, primarily Greece, Spain and Italy, our accounts receivable balances are significant. At March 31, 2001, our past due accounts receivable for Greece, Spain and Italy totaled approximately $19.5 million, of which $9.2 million was more than 120 days past due. This compares to past due receivables of approximately $19.3 million at December 31, 2000 for these same countries, of which $10.9 million was more than 120 days past due. To date, we have experienced only modest losses with respect to the collection of our accounts receivable and believe that the past due accounts receivable for Greece, Spain and Italy are collectible.

    Other significant changes in working capital during the three months ended March 31, 2001 included a $3.4 million increase in prepaid expenses and other assets due primarily to the $2.0 million milestone payment due from Roche and a $0.5 million increase in prepaid insurance. Accounts payable decreased in the three months ended March 31, 2001 primarily due to accrued contract obligations at December 31, 2000 that have since been paid. The decrease in current deferred revenue is primarily due to the $1.7 million amortization of the EyeTech up-front license fee.

13


    The primary elements of the increase in other assets was the $2.4 million unrecognized portion of the $13.0 million license fee payment to Cubist and the $1.1 million valuation of a warrant to purchase stock in EyeTech recognized in accordance with SFAS 133.

    Through April 2001 we maintained a $10.0 million unsecured line of credit with a major financial institution bearing interest at a floating rate. Under the terms of the line of credit, we were required to maintain certain financial ratios and there were limitations on our ability to incur additional debt or to engage in certain significant transactions. As of March 31, 2001, we had no outstanding borrowings under the line. The line of credit, which included a foreign exchange facility, expired on April 16, 2001. We renewed the foreign exchange facility but did not renew the line of credit. Under the terms of the new foreign exchange facility we will be required to maintain a minimum cash investment balance with the financial institution. Our cash investment balance with that institution presently exceeds the minimum balance. There are no required financial ratios or limitations on debt or other transactions under the foreign exchange facility.

    We believe that our existing capital resources, supplemented by net product sales, contract and royalty revenues will be adequate to satisfy our capital needs for the foreseeable future. As of March 31, 2001, we are entitled to additional cash payments of up to $9.6 million from Roche, if and when Roche achieves specific additional Tamiflu developmental and regulatory milestones. We are also entitled to additional cash payments from EyeTech of up to $25.0 million, if and when EyeTech achieves certain NX 1838 milestones. We cannot be assured that any of these milestones will be met. Our future capital requirements will depend on many factors, including:

    We may in the future require additional funding, which could be in the form of proceeds from equity or debt financings or additional collaborative agreements with corporate partners. If such funding is required, we cannot be assured that it will be available on favorable terms, if at all.

14



ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

    As of March 31, 2001, our $250.0 million convertible subordinated notes had a fair value of $169.0 million. There have been no other significant changes in our market risk compared to the disclosures in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2000.

15



PART II. OTHER INFORMATION

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

    A Special Meeting of Stockholders was held on February 2, 2001 in Redwood City, California. Of the 94,171,488 shares of Gilead Common Stock entitled to vote at the meeting, 75,664,638 shares were represented at the meeting in person or by proxy, constituting a quorum. The stockholders approved an amendment to Gilead's Certificate of Incorporation to increase the authorized number of shares of Common Stock from 100,000,000 shares to 500,000,000 shares. There were 59,152,774 votes cast for the proposal, 16,451,600 votes cast against, 60,264 abstentions and there were no broker non-votes.


ITEM 5. OTHER MATTERS

    In early May 2001, Gilead submitted a New Drug Application with the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products for marketing approval of tenofovir disoproxil fumarate (tenofovir DF), an investigational reverse transcriptase inhibitor in development for the treatment of HIV infection.


ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K

(a)
Exhibits
(b)
Reports on Form 8-K

    None.


*
Confidential treatment requested as to specific portions, which portions are omitted and filed separately with the Securities and Exchange Commission.

16



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: May 14, 2001

 

/s/ JOHN C. MARTIN

John C. Martin
President and Chief Executive Officer

Date: May 14, 2001

 

/s/ SHARON A. SURREY-BARBARI

Sharon A. Surrey-Barbari
Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)

17




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GILEAD SCIENCES, INC. INDEX
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share amounts)
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands)
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SIGNATURES
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Exhibit 10.42

MARKETING, DISTRIBUTION AND DEVELOPMENT AGREEMENT

BY AND BETWEEN

GILEAD SCIENCES, INC.

AND

CUBIST PHARMACEUTICALS, INC.

January 6, 2001

[*]=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.


TABLE OF CONTENTS

 
   
  PAGE
ARTICLE 1   DEFINITIONS   1
  1.1   "Affiliate"   1
  1.2   "Bacteremia"   1
  1.3   "CAP"   1
  1.4   "Change in Control"   1
  1.5   "Clinical Transfer Price"   1
  1.6   "Commercial Launch"   1
  1.7   "Commercialize"   1
  1.8   "Commercially Reasonable Efforts"   2
  1.9   "Compulsory License"   2
  1.10   "Confidential Information"   2
  1.11   "Control"   2
  1.12   "Core IV Products"   2
  1.13   "Core Licensed Products"   2
  1.14   "Core Trials"   2
  1.15   "CPMP"   2
  1.16   "cSST"   2
  1.17   "Cubist Development Plan"   2
  1.18   "Cubist Diligence Obligation"   2
  1.19   "Cubist Know-How"   2
  1.20   "Cubist Marks"   2
  1.21   "Cubist Patent"   2
  1.22   "Cubist Technology"   2
  1.23   "cUTI"   2
  1.24   "Daptomycin"   3
  1.25   "Daptomycin Product"   3
  1.26   "Daptomycin-Derived Product"   3
  1.27   "Development Subcommittee"   3
  1.28   "Diligence Obligation"   3
  1.29   "Directly Competitive Product"   3
  1.30   "Dollar"   3
  1.31   "Drug Approval Application"   3
  1.32   "EC"   3
  1.33   "EMEA"   3
  1.34   "Endocarditis"   3
  1.35   "Enterococcal Infection"   3
  1.36   "FDA"   3
  1.37   "Force Majeure   3
  1.38   "Free Sales Certificate"   3
  1.39   "Gilead Development Plan"   4
  1.40   'Gilead Diligence Obligation"   4
  1.41   "Gilead Indemnifiable Technology"   4
  1.42   "Gilead Indemnifiable Technology Losses"   4
  1.43   "Gilead Marks"   4
  1.44   "Gilead Project Know-How"   4
  1.45   "Gilead Project Patent"   4
  1.46   "Gilead Project Technology"   4

i


  1.47   "Gilead Territory"   4
  1.48   "HAP"   4
  1.49   "Incremental Product Development Costs"   4
  1.50   "IND"   4
  1.51   "Information"   4
  1.52   "Infringement"   4
  1.53   "IV Product"   4
  1.54   "Joint Invention"   5
  1.55   "Joint Patent"   5
  1.56   "Licensed Product"   5
  1.57   "Lilly"   5
  1.58   "Lilly License"   5
  1.59   "Loss"   5
  1.60   "MAA"   5
  1.61   "Marketing Subcommittee"   5
  1.62   "MSL"   5
  1.63   "NDA"   5
  1.64   "Necessary"   5
  1.65   "Net Sales"   5
  1.66   "Oral Product"   6
  1.67   "Oral Product Fee"   6
  1.68   "Other Licensee"   6
  1.69   "Patent"   6
  1.70   "Permitted Sublicense"   6
  1.71   "Phase I Clinical Trial"   6
  1.72   "Phase II Clinical Trial"   6
  1.73   "Phase III Clinical Trials"   6
  1.74   "Phase IIIB Clinical Trials"   6
  1.75   "Phase IV Clinical Trials"   6
  1.76   "Price Approval"   7
  1.77   "Primary Endpoint"   7
  1.78   "Refund Event"   7
  1.79   "Regulatory Approval"   7
  1.80   "Regulatory Authority"   7
  1.81   "Related Gilead Know-How"   7
  1.82   "Related Gilead Project Patent"   7
  1.83   "Related Gilead Technology"   7
  1.84   "ROFR Territory"   7
  1.85   "Steering Committee"   7
  1.86   "Supply Agreement"   7
  1.87   "Term"   7
  1.88   "Third Party Royalties"   7
  1.89   "Third Party"   7
  1.90   "Transfer Price"   7
  1.91   "Valid Claim"   7
ARTICLE 2   MANAGEMENT   8
  2.1   General   8
  2.2   Steering Committee   8
  2.3   Formation of Subcommittees   9
  2.4   Project Coordinators   11

ii


  2.5   Collaboration Guidelines   11
  2.6   Accounting   11
ARTICLE 3   DEVELOPMENT   11
  3.1   Cubist Development, Development Plan, and Diligence Obligation   11
  3.2   Gilead Development Plan   13
  3.3   Responsibilities of the Development Subcommittee during Development   13
  3.4   Modification of Clinical Trials; Incremental Product Development Costs   13
  3.5   Determination of Cubist Diligence   14
ARTICLE 4   REGULATORY   15
  4.1   General   15
  4.2   Free Sales Certificates; Ownership of Regulatory Approvals   15
  4.3   Gilead Access to Cubist and Other Licensee Information   16
  4.4   Cubist and Other Licensee Access to Gilead Information   17
  4.5   Adverse Event Reporting   17
  4.6   Communications   17
  4.7   Applications for Regulatory Exclusivity   17
  4.8   Recalls and Voluntary Withdrawals   17
  4.9   Label   18
ARTICLE 5   COMMERCIALIZATION; DILIGENCE   19
  5.1   Right   19
  5.2   Responsibilities of the Marketing Subcommittee during Commercialization   19
  5.3   Marketing Plan   19
  5.4   Activities by MSLs in Gilead Territory   19
  5.5   Diligence Obligation   20
  5.6   Determination of Gilead's Diligence   21
  5.7   Diversion of Resources for Directly Competitive Product   21
  5.8   Discounting   22
  5.9   Gilead Compliance   22
ARTICLE 6   LICENSE; RIGHTS OF FIRST REFUSAL; EXCLUSIVITY   22
  6.1   Patent Licenses to Gilead   22
  6.2   Patent Licenses to Cubist   22
  6.3   Nonexclusive Know-How License to Gilead   23
  6.4   Nonexclusive Know-How License to Cubist   23
  6.5   Rights of First Refusal and Negotiation   23
  6.6   Exclusivity   24
  6.7   Trademark License   24
  6.8   Third Party Technology   25
    (a) Required   25
    (b) Desirable   25
  6.9   Sublicensed Technology   25
  6.10   Related Gilead Technology.   26
  6.11   Sublicensing   26
  6.12   Use of Patents and Know-How   26
  6.13   Field   26
ARTICLE 7   MANUFACTURE AND SUPPLY   26
  7.1   Supply by Cubist   26
  7.2   Transfer Price   27
ARTICLE 8   COMPENSATION   28
  8.1   License Fee   28
  8.2   Milestone Payments   28

iii


  8.3   Royalties   29
  8.4   Term of Royalties   30
  8.5   Third Party Royalties and Other Payments   30
  8.6   Royalty Payments and Reports   30
  8.7   Taxes   30
  8.8   Blocked Currency   30
  8.9   Foreign Exchange   30
  8.10   Payments to or Reports by Affiliates   31
  8.11   Late Payments.   31
ARTICLE 9   INTELLECTUAL PROPERTY   31
  9.1   Ownership of Inventions   31
  9.2   Prosecution of Patents   31
  9.3   Patent Term Extensions.   32
  9.4   Non-Patent Regulatory Exclusivity   32
  9.5   Infringement of Patents by Third Parties   32
  9.6   Infringement of Third Party Rights   34
  9.7   Royalty Reduction   35
  9.8   Patent Marking   35
  9.9   Selection and Registration of Product Trademarks   35
  9.10   Infringement of Trademarks by Third Parties   36
  9.11   Patent Oppositions   36
    (a) Third Party Patent Rights   36
    (b) Parties' Patent Rights   36
    (c) Noncontravention   36
  9.12   Lilly License   36
ARTICLE 10   REPRESENTATIONS AND WARRANTIES   36
  10.1   Mutual Representations and Warranties   36
  10.2   Cubist   37
  10.3   Disclaimer   38
  10.4   No Other Representations   38
ARTICLE 11   INDEMNIFICATION   38
  11.1   Indemnification by Cubist   38
  11.2   Indemnification by Gilead   38
  11.3   Procedure   38
  11.4   Insurance   39
  11.5   No Application to Third Party Infringement Claims   39
  11.6   Limitation of Liability   39
ARTICLE 12   RECORDS; PUBLICATIONS   39
  12.1   Records   39
  12.2   Publications   40
ARTICLE 13   CONFIDENTIALITY   40
  13.1   Treatment of Confidential Information   40
  13.2   Authorized Disclosure   41
  13.3   Publicity   41
ARTICLE 14   TERM AND TERMINATION   41
  14.1   Term   41
  14.2   Termination by Gilead   41
  14.3   Termination for Breach   42
  14.4   Cubist Rights upon Certain Terminations of the Agreement or as to Certain Licensed Products   42

iv


  14.5   Gilead Rights upon Certain Terminations   43
  14.6   Survival   43
  14.7   Clarification with respect to Supply Agreement.   43
  14.8   Repurchase of Inventory   43
ARTICLE 15   DISPUTE RESOLUTION   44
  15.1   Disputes   44
  15.2   Governing Law; Judicial Resolution   44
  15.3   Patent and Trademark Dispute Resolution   44
  15.4   [*] Resolution of Certain Disputes   44
ARTICLE 16   MISCELLANEOUS   45
  16.1   Entire Agreement; Amendment   45
  16.2   Force Majeure   45
  16.3   Notices   45
  16.4   Maintenance of Records   46
  16.5   No Strict Construction   46
  16.6   Assignment   46
  16.7   Performance by Affiliates   46
  16.8   Counterparts   47
  16.9   Further Actions   47
  16.10   Severability   47
  16.11   Headings   47
  16.12   No Waiver   47

v


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.

MARKETING, DISTRIBUTION AND DEVELOPMENT AGREEMENT

    THIS MARKETING, DISTRIBUTION AND DEVELOPMENT AGREEMENT (the "Agreement") is made effective as of the 6th day of January, 2001 (the "Effective Date") by and between GILEAD SCIENCES, INC., a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404 ("Gilead"), and CUBIST PHARMACEUTICALS, INC., a Delaware corporation having its principal place of business at 24 Emily Street, Cambridge, Massachusetts 02139 ("Cubist"). Cubist and Gilead are sometimes referred to herein individually as a "Party" and collectively as the "Parties", and references to "Gilead" and "Cubist" shall include their respective Affiliates.

RECITALS

    WHEREAS, Cubist has in-licensed and continues to develop a proprietary compound known under the generic name of daptomycin;

    WHEREAS, Cubist is currently conducting clinical trials of an intravenous formulation of daptomycin for the treatment of various gram-positive bacterial infections in humans, and is evaluating an oral formulation of daptomycin in preclinical studies;

    WHEREAS, Gilead possesses extensive capabilities in the development, promotion and marketing of anti-infective pharmaceutical products in Europe and desires to seek regulatory approval for and market daptomycin in Europe; and

    WHEREAS, Gilead desires to obtain the exclusive right to develop and commercialize daptomycin in the European Community and certain additional countries, and Cubist desires to grant Gilead such rights in such countries all as set forth below;

    NOW THEREFORE, based on the foregoing premises and the mutual covenants and obligations set forth below, the Parties agree as follows:


ARTICLE 1
DEFINITIONS

    The following terms shall have the following meanings as used in this Agreement:

    1.1 "Affiliate" shall mean, except as provided below, an entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with Cubist or Gilead.

    1.2 "Bacteremia" shall mean the treatment of a blood-borne infection caused by any bacteria.

    1.3 "CAP" shall mean the treatment of community acquired pneumonia.

    1.4 "Change in Control" shall mean that a Third Party shall have become the beneficial owner of securities representing [*] or more of the aggregate voting power of the then outstanding voting securities of Cubist, or any sale by Cubist of all or substantially all of Cubist's assets.

    1.5 "Clinical Transfer Price" shall have the meaning assigned such term in Section 7.2.

    1.6 "Commercial Launch" shall mean the first sale of a Licensed Product to a Third Party in a given country.

    1.7 "Commercialize" shall have the meaning assigned such term in Section 5.1 and "Commercialization" shall be interpreted accordingly.


    1.8 "Commercially Reasonable Efforts" shall mean, with respect to a Party's obligation under this Agreement to develop or commercialize Licensed Product, the level of efforts required to carry out such obligation in sustained manner consistent with the efforts a similarly situated biopharmaceutical company devotes to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing.

    1.9 "Compulsory License" shall mean a compulsory license under any Cubist Patent obtained by a Third Party through the order, decree, or grant of a governmental authority of competent jurisdiction, authorizing such Third Party to manufacture, use, sell, offer for sale or import a product competitive with a Licensed Product in one or more countries within the Gilead Territory.

    1.10 "Confidential Information" shall mean all Information, and other information and materials, received by either Party from the other Party pursuant to this Agreement, other than that portion of such information or materials which:

    1.11 "Control" shall mean possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

    1.12 "Core IV Products" shall mean those IV Products whose primary therapeutic indication is CAP or cSST.

    1.13 "Core Licensed Products" shall mean those Licensed Products whose primary therapeutic indication is CAP or cSST.

    1.14 "Core Trials" shall mean the clinical trials listed on Exhibit A under the title "Core Trials."

    1.15 "CPMP" shall mean the Committee for Proprietary Medicinal Products, which represents the medicine authorities of the European Community member states.

    1.16 "cSST" shall mean the treatment of complicated skin and soft tissue bacterial infection.

    1.17 "Cubist Development Plan" shall have the meaning assigned such term in Section 3.1.

    1.18 "Cubist Diligence Obligation" shall have the meaning assigned such term in Section 3.5.

    1.19 "Cubist Know-How" shall mean all Information which is [*]. Notwithstanding anything herein to the contrary, Cubist Know-How shall exclude Information [*].

    1.20 "Cubist Marks" shall mean (i) all [*] listed at Exhibit B; (ii) the [*]; and (iii) any other [*] that the Parties may agree in writing to designate for [*].

    1.21 "Cubist Patent" shall mean any Patent which (i) covers [*]; and (ii) is [*], including [*].

    1.22 "Cubist Technology" shall mean all Cubist Patents and Cubist Know-How.

    1.23 "cUTI" shall mean the treatment of complicated urinary tract infections.

2


    1.24 "Daptomycin" shall mean the compound set forth and identified as the primary daptomycin molecule on Exhibit C, [*] of such compound, which [*], and all [*] of such primary daptomycin molecule, [*].

    1.25 "Daptomycin Product" shall mean any pharmaceutical composition containing Daptomycin, but only if such pharmaceutical composition is formulated for use for oral delivery [*] or for delivery via injection [*], and that [*]; provided, however, that in any event, [*] is developing pursuant to its [*] for development of [*] shall be deemed to be a Licensed Product.

    1.26 "Daptomycin-Derived Product" shall mean any pharmaceutical composition   [*] and that [*], but excluding Daptomycin Products.

    1.27 "Development Subcommittee" shall have the meaning assigned such term in Section 2.3(a).

    1.28 "Diligence Obligation" shall mean the Gilead Diligence Obligation and/or the Cubist Diligence Obligation.

    1.29 "Directly Competitive Product" shall mean any antibiotic in any formulation marketed and sold (i) primarily for [*] (provided that this clause (i) shall apply solely for the purpose of determining whether a product is competitive with [*] Licensed Product and shall not apply for the purpose of determining whether a product is competitive with any Licensed Product other than [*]), (ii) primarily to [*] in humans, and (iii) for [*] approved by a Regulatory Authority in the Gilead Territory including, as the primary indication for the product, an indication that is also included on the label approved by a Regulatory Authority in the Gilead Territory for any Licensed Product. The Parties shall, at the time Cubist or Gilead commences Phase III Clinical Trials for an Oral Product that is a Licensed Product, modify this definition by mutual agreement to accommodate products competitive with such Oral Product, considering the terms of this Section 1.29 as guiding principles (it being understood that [*] of such Oral Product may not necessarily be [*]). If the Parties do not agree, the issue shall be submitted for resolution [*] as provided in Section 15.4.

    1.30 "Dollar" shall mean a United States dollar, and "$" shall be interpreted accordingly.

    1.31 "Drug Approval Application" shall mean an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction, including without limitation an NDA filed in the United States.

    1.32 "EC" shall mean the European Community.

    1.33 "EMEA" shall mean the European Medicines Evaluation Agency, or any successor thereto, which coordinates the scientific review of human pharmaceutical products under the centralized licensing procedures of the European Community.

    1.34 "Endocarditis" shall mean the treatment of inflammation of the heart and/or its valves resulting from a bacterial infection.

    1.35 "Enterococcal Infection" shall mean the treatment of enterococcal bacterial infections.

    1.36 "FDA" shall mean the United States Food and Drug Administration, or any successor thereto.

    1.37 "Force Majeure" shall mean any event beyond the control of the relevant Party, including, without limitation, fire, flood, earthquakes, riots, strikes, epidemics, war (declared or undeclared and including the continuance, expansion or new outbreak of any war or conflict now in existence), embargoes and governmental actions or decrees.

    1.38 "Free Sales Certificate" shall mean market approval sufficient for the manufacture, distribution, use and sale of Licensed Products outside of the United States which can be obtained primarily on the basis of U.S. FDA, EMEA or other European Regulatory Approval and without the conduct of additional clinical trials, and shall include both market approvals referred to commonly as

3


"free sales certificates" and similar market approvals or certificates referred to by other names, provided that such similar market approvals or certificates do not impose a substantially greater burden on the applicant than those market approvals commonly referred to as "free sales certificates."

    1.39 "Gilead Development Plan" shall have the meaning assigned such term in Section 3.2.

    1.40 "Gilead Diligence Obligation" shall have the meaning assigned such term in Section 5.6.

    1.41 "Gilead Indemnifiable Technology" shall have the meaning assigned such term in Section 9.6(d)(ii).

    1.42 "Gilead Indemnifiable Technology Losses" shall have the meaning assigned such term in Section 9.6(d)(ii).

    1.43 "Gilead Marks" shall mean (i) all [*] listed at Exhibit D as it may be updated from time to time; (ii) any [*] in connection with Licensed Products in the Gilead Territory; and (iii) any other [*] that the Parties may agree in writing to designate for [*].

    1.44 "Gilead Project Know-How" shall mean all Information that (i) Gilead [*], (ii) covers the [*] and (iii) is [*]. Gilead Project Know-How shall exclude Information [*]. Gilead Project Know-How shall include any [*] that the Parties agree in writing to include in the Gilead Project Know-How [*].

    1.45 "Gilead Project Patent" shall mean any Patent that (i) claims [*] (ii) covers the [*], (iii) is [*], and (iv) is [*]. Gilead Project Patents include Gilead's interest in [*] that the Parties agree in writing to include in the Gilead Project Patents [*].

    1.46 "Gilead Project Technology" shall mean the Gilead Project Know-How and Gilead Project Patents.

    1.47 "Gilead Territory" shall mean the countries listed in Exhibit E and any other country that is added to the Gilead Territory pursuant to Section 6.5(a), and the possessions and territories of each such country.

    1.48 "HAP" shall mean the treatment of hospital-acquired pneumonia.

    1.49 "Incremental Product Development Costs" shall mean the costs attributed to the implementation of a Proposed Modification, as determined by the Steering Committee pursuant to Section 3.4.

    1.50 "IND" shall mean an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by 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 Licensed Product in humans in a particular jurisdiction.

    1.51 "Information" shall mean (i) techniques and data specifically relating to development, manufacture, use or sale of Licensed Products, including, but not limited to, inventions, practices, methods, knowledge, know-how, skill, experience, test data including pharmacological, toxicological and clinical test data, analytical and quality control data, regulatory submissions, correspondence and communications, marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data or descriptions and (ii) compositions of matter, assays and biological materials specifically relating to development, manufacture, use or sale of Licensed Products.

    1.52 "Infringement" shall have the meaning assigned in Section 9.5.

    1.53 "IV Product" shall mean any Daptomycin Product formulated for intravenous delivery, including without limitation the formulation described by the specifications set forth in a letter that Cubist has provided to Gilead prior to the Effective Date.

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    1.54 "Joint Invention" shall have the meaning assigned in Section 9.1.

    1.55 "Joint Patent" shall have the meaning assigned such term in Section 9.2.

    1.56 "Licensed Product" shall mean all Daptomycin Products, and all Daptomycin—Derived Products that become Licensed Products pursuant to Section 6.5(b).

    1.57 "Lilly" shall mean Eli Lilly and Company.

    1.58 "Lilly License" shall mean that certain Licensing Agreement between Cubist and Lilly dated October 6, 2000, which restated the prior agreement between such parties dated November 7, 1997, as amended.

    1.59 "Loss" shall have the meaning assigned such term in Section 11.1.

    1.60 "MAA" shall mean an application filed with the EMEA for regulatory approval to market and sell Licensed Products in the European Union, or an application filed through the mutual recognition procedures in the European Union having a similar purpose to the NDA in the United States.

    1.61 "Marketing Subcommittee" shall have the meaning assigned such term in Section 2.3(b).

    1.62 "MSL" shall mean a Cubist employee serving as a medical science liaison for commercialization of Licensed Products, as provided in Section 5.4.

    1.63 "NDA" shall mean a New Drug Application for Regulatory Approval filed in the United States.

    1.64 "Necessary" shall have the meaning assigned such term in Section 6.8(a).

    1.65 "Net Sales" shall mean, with respect to a particular time period, the amount billed by Gilead, its Affiliates and Permitted Sublicensees for sales of Licensed Products made in such time period to a Third Party less:

    If Gilead sells Licensed Products in the form of a combination product containing one or more active ingredients in addition to Daptomycin (which may be either combined in a single formulation or packaged as separate formulations sold as a single package), Net Sales for such combination product will be calculated by multiplying actual Net Sales of such combination product by the fraction A/(A+B) where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of the other active ingredient or ingredients in the combination, if sold separately. If, on a country-by-country basis, the other active ingredient or ingredients in the combination are not sold separately in said country, Net Sales for the purpose of determining royalties of the combination product shall be calculated by multiplying actual Net Sales of such combination product by the fraction A/C where A is the invoice price of the Licensed Product if sold separately, and C is the invoice price of the combination product. If, on a country-by-country basis, the Licensed Product is not sold

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separately in said country, Net Sales for the purposes of determining royalties of the combination product shall be determined by the Steering Committee in good faith on the basis of the fair market value of the Licensed Product.

    Notwithstanding the foregoing, amounts received by Gilead, its Affiliates or Permitted Sublicensees for the sale of Licensed Products among Gilead, its Affiliates and Permitted Sublicensees for resale shall not be included in the computation of Net Sales hereunder.

    For purposes of this definition and the other provisions of this Agreement, no distributor of Gilead that sells a Licensed Product shall be deemed to be a Permitted Sublicensee of Gilead unless expressly so agreed in writing by the Parties. If any distributor of Licensed Products makes any payment to Gilead, its Affiliates or Permitted Sublicensees in consideration of being a distributor of any Licensed Product, which payment would not, but for the provisions of this sentence, be included in the definition of Net Sales, then the amount of such payment to Gilead, its Affiliates or Permitted Sublicensees shall be included in Net Sales in the quarter in which Gilead, its Affiliates or Permitted Sublicensees received such payment for purposes of calculating the royalty due to Cubist pursuant to Article 8.

    1.66 "Oral Product" shall mean any Daptomycin Product formulated for oral delivery, [*].

    1.67 "Oral Product Fee" shall have the meaning assigned such term in Section 8.1(b).

    1.68 "Other Licensee" shall mean any Third Party to whom Cubist has granted or grants a license and/or sublicense to develop or commercialize a Licensed Product.

    1.69 "Patent" shall mean (i) unexpired letters patent (including inventor's certificates) which have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal or any like filing thereof and (ii) pending applications for letters patent, including without limitation any provisional, converted provisional, continued prosecution application, continuation, divisional or continuation-in-part thereof.

    1.70 "Permitted Sublicense" shall have the meaning assigned such term in Section 6.11.

    1.71 "Phase I Clinical Trial" shall mean those trials on sufficient numbers of normal volunteers and patients that are designed to establish that a pharmaceutical product is safe for its intended use, and to support its continued testing in Phase II Clinical Trials.

    1.72 "Phase II Clinical Trial" shall mean those trials on sufficient numbers of patients that are designed to establish the safety, dosage and biological activity of a pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed.

    1.73 "Phase III Clinical Trials" means those trials on sufficient numbers of patients that are designed to establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, and supporting Regulatory Approval of such drug or label expansion of such drug.

    1.74 "Phase IIIB Clinical Trials" means product support clinical trials of a Licensed Product (i.e., a clinical trial which is not required for receipt of Regulatory Approval but which may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval in the country where such trial is being conducted.

    1.75 "Phase IV Clinical Trials" means product support clinical trials of a Licensed Product commenced after receipt of Regulatory Approval in the country where such trial is being conducted.

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    1.76 "Price Approval" shall mean, with respect to any country in which the price at which Gilead sells Licensed Product must be approved by a governmental authority for reimbursement or payment purposes, the receipt of approval by the applicable governmental authority with respect to such price.

    1.77 "Primary Endpoint" shall mean, with respect to a clinical trial, the point at which equivalence to the comparator agent has been achieved with respect to a clinical or microbiological outcome as specified in the protocol for such trial as set forth in Exhibit A, unless otherwise agreed by the Parties in writing.

    1.78 "Refund Event" shall have the meaning assigned such term in Section 8.1(c).

    1.79 "Regulatory Approval" shall mean any approvals (including supplements, amendments, pre- and post-approvals and Price Approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of Licensed Products in a regulatory jurisdiction.

    1.80 "Regulatory Authority" shall mean a foreign counterpart of the FDA.

    1.81 "Related Gilead Know-How" shall mean all Information [*] (i) which is [*], (ii) is [*] and (iii) relates to [*].

    1.82 "Related Gilead Project Patent" shall mean any Patent other than a Gilead Project Patent which (i) covers [*]; and (ii) is [*], including Gilead's interest in [* ].

    1.83 "Related Gilead Technology" shall mean the Related Gilead Know-How and Related Gilead Project Patents.

    1.84 "ROFR Territory" shall mean those countries listed at Exhibit F and their territories and possessions. The ROFR Territory shall also include [*], but shall exclude [*] and with respect to which [*]; provided, however, that any such country that is not included in the ROFR Territory [* ] shall be included in the ROFR Territory upon and from the date [*].

    1.85 "Steering Committee" shall mean the committee formed as described in Section 2.2.

    1.86 "Supply Agreement" shall have the meaning assigned such term in Section 7.1.

    1.87 "Term" shall mean the term of this Agreement.

    1.88 "Third Party Royalties" shall mean royalties payable to any Third Party as a result of the manufacture, use or sale of Licensed Products pursuant to, and in accordance with, the provisions of this Agreement or the Supply Agreement, including without limitation royalties due under the Lilly License.

    1.89 "Third Party" shall mean any entity other than Cubist or Gilead or an Affiliate of either of them.

    1.90 "Transfer Price" shall mean the price to Gilead for supply of a unit of Licensed Product manufactured by or for Cubist, which shall be determined annually in accordance with Section 7.2.

    1.91 "Valid Claim" shall mean (i) an unexpired claim of an issued patent within Cubist Patents which has not been found to be unpatentable, invalid or unenforceable by a court or other authority in the subject country, from which decision no appeal is taken or can be taken; or (ii) a claim of a pending application within the Cubist Patents, which application claims a first priority no more than [* ] prior to the date upon which pendency is determined.

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ARTICLE 2
MANAGEMENT

    2.1 General. The Parties desire to establish a committee that will oversee the Parties' activities under this Agreement, and establish two (2) or more subcommittees to exchange information regarding, and to discuss the Parties' development and commercialization of, Licensed Products both within and outside of the Gilead Territory. Such committee and subcommittees shall have the responsibilities and authority set forth in this Article 2 and in other provisions of this Agreement.

    2.2 Steering Committee.

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    2.3 Formation of Subcommittees.

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    2.4 Project Coordinators. Each Party will, promptly after the formation of each subcommittee pursuant to Section 2.3, assign an appropriately expert and experienced individual to the other Party to facilitate communication and coordination of activities relating to the development and commercialization of Licensed Products and to provide support and guidance to the subcommittee (the "Project Coordinator"). Each Project Coordinator shall be experienced in project management.

    2.5 Collaboration Guidelines.

    2.6 Accounting. Each Party shall determine Incremental Product Development Costs and all other costs and expenses that may be shared with or reimbursed to a Party under this Agreement or the Supply Agreement (including without limitation the amounts Gilead shall pay to Cubist for supply of Licensed Products pursuant to the Supply Agreement), if any, using its standard accounting procedures, consistently applied, to the maximum extent practical as if such Licensed Product were a solely owned product of the determining Party, except as specifically provided in this Agreement. The Parties also recognize that such procedures may change from time to time and that any such changes may affect the definition of Incremental Product Development Costs and such other costs and expenses. The Parties agree that, where such changes are economically material to either Party, adjustments shall be made to compensate the affected Party in order to preserve the same economics as reflected under this Agreement under such Party's accounting procedures in effect as of the Effective Date.

ARTICLE 3
DEVELOPMENT

    3.1 Cubist Development, Development Plan, and Diligence Obligation.

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    3.2 Gilead Development Plan. Gilead may, but shall not be obligated to, conduct [*] for Licensed Products, and such other development activities that Gilead, in its discretion, deems desirable to [*] for Licensed Products for which Regulatory Approval has been obtained. Such studies may also include [*] on Licensed Products. Any development activities that Gilead may conduct for the Licensed Products shall be set forth in a development plan which Gilead shall prepare and submit to the Steering Committee for review promptly after Gilead has designed such trial, but in no event later than the date provided in Section 3.4 for submission of a protocol for consideration by the Steering Subcommittee (such plan, the "Gilead Development Plan"). Gilead shall modify the Gilead Development Plan from time to time to reflect changes to the timing or protocol for the clinical trials described therein, or to reflect trials that Gilead determines, in its sole discretion, to conduct or terminate during the Term. Any clinical trials that Gilead conducts under this Section 3.2 may be run at sites outside of the Gilead Territory, provided that Gilead confers with Cubist on the design of any such trial, and that the data generated therein shall be used by Gilead, its Affiliates or Permitted Sublicensees solely to support Regulatory Approval in the Gilead Territory. Gilead shall update the Gilead Development Plan [*] and submit such plan to the Development Subcommittee for review and comment. [*] shall [*] in connection with any of the activities reflected in the Gilead Development Plan, except as otherwise provided in Section 3.4.

    3.3 Responsibilities of the Development Subcommittee during Development. The Development Subcommittee will review the overall strategy for and design of all programs under the Cubist Development Plan and the Gilead Development Plan. The Development Subcommittee shall review and make recommendations to the Steering Committee whether to approve any proposals by one Party to modify clinical trials being planned by the other Party, as described in Section 3.4 and prepare initial estimates and budgets for shared Incremental Product Development Costs as may be required under Section 3.4.

    3.4 Modification of Clinical Trials; Incremental Product Development Costs.

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    3.5 Determination of Cubist Diligence. If Gilead believes that Cubist is not meeting its diligence obligation pursuant to Section 3.1 (such obligation, the "Cubist Diligence Obligation") with respect to any Licensed Product, Gilead shall notify Cubist. Cubist shall respond in writing to Gilead's notice as to Cubist's activities that it believes meets the Cubist Diligence Obligation with respect to such Licensed Product as well as the circumstances surrounding Cubist's development of the Licensed Products within [ *] of Cubist's receipt of such notice from Gilead. Gilead shall reply to Cubist within [*] after receiving such written response from Cubist whether, in light of such response, Gilead continues to believe that Cubist has not met the Cubist Diligence Obligation with respect to such

14


Licensed Product. If, after following the foregoing procedures in this Section 3.5, the Parties continue to disagree whether Cubist has met the Cubist Diligence Obligation with respect to such Licensed Product, the Parties shall [*] to be convened within [*] of such reply from Cubist. [*] shall examine and discuss for [ *] Cubist's efforts to develop such Licensed Product [*]. After such examinations and discussions:


ARTICLE 4
REGULATORY

    4.1 General. Gilead shall devote Commercially Reasonable Efforts to file for and obtain Regulatory Approval for those Licensed Products in the Gilead Territory for which Cubist obtains Regulatory Approval in the United States and regarding which Cubist provides Gilead with clinical data sufficient to support Regulatory Approval in the Gilead Territory. Notwithstanding anything in this Agreement to the contrary, Gilead shall not be required pursuant to this Agreement, but may elect, to [*]. In recognition that Gilead's efforts to obtain Regulatory Approval for Licensed products in the Gilead Territory will depend upon its ability to use data relating to Licensed Products generated by Cubist outside of the Gilead Territory in making regulatory filings within the Gilead Territory, Cubist shall devote Commercially Reasonable Efforts to obtain clinical data to support, file for and obtain Regulatory Approval for Core Licensed Products outside the Gilead Territory in accordance with the provisions of Article 3.

    4.2 Free Sales Certificates; Ownership of Regulatory Approvals.

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    4.3 Gilead Access to Cubist and Other Licensee Information.

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    4.4 Cubist and Other Licensee Access to Gilead Information.

    4.5 Adverse Event Reporting. The Parties shall report, and take other actions in relation to, adverse events with Licensed Products to each other in accordance with a reporting protocol that will be substantially in the form of the protocol used by Gilead under its relationship with [*].

    4.6 Communications. Except as may be required by law or as contemplated pursuant to Section 4.2, Cubist shall not communicate regarding any Licensed Product with any Regulatory Authority having jurisdiction in the Gilead Territory unless requested to do so by Gilead.

    4.7 Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of the countries in the Gilead Territory are likely to be [*] to Licensed Products. To the extent permitted by law, Gilead shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Licensed Products in the Gilead Territory, including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Licensed Product, and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights, and Cubist shall reasonably cooperate with Gilead in such actions [* ]. In countries where Gilead is not entitled to take one or more of the actions described in the foregoing sentence, then Cubist shall take such actions as instructed by Gilead and for the benefit of Gilead, [*]. Gilead shall own any regulatory exclusivity rights in the Gilead Territory where permitted by law. Cubist hereby grants Gilead the exclusive right to market Licensed Products in the Gilead Territory under any regulatory exclusivity rights that must be granted directly to Cubist in a given country in the Gilead Territory.

    4.8 Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures ("SOPs") as to product recalls reasonably in advance of Commercial Launch of any Licensed Product in the Gilead Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the specifications for Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The Steering Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 4.8. Gilead shall have the right to

17


control, [*], a recall of the Licensed Product in the Gilead Territory, unless such recall is caused by a Manufacturing Defect (as defined by the Supply Agreement), in which case [*] shall [*] associated with the recall. Cubist shall control, [*], all recalls of Licensed Product outside the Gilead Territory. Gilead shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than [* ].

    4.9 Label. To the extent permitted by law, Gilead shall identify Cubist as the manufacturer or licensor of each Licensed Product on the outside of the packaging for such Licensed Product in each country of the Gilead Territory in a manner approved in advance in writing by Cubist, such consent not to be unreasonably withheld.

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ARTICLE 5
COMMERCIALIZATION; DILIGENCE

    5.1 Right. Gilead shall have the exclusive right to market and commercialize, including, without limitation, by conducting pre-marketing, advertising and promotion activities, and sponsoring medical education events, exhibits and symposia (collectively, "Commercialize") Licensed Products in all countries of the Gilead Territory during the Term, for its own account (subject to the [*] under this Agreement), [*] and subject to the participation of the Cubist MSLs as provided below in Section 5.4.

    5.2 Responsibilities of the Marketing Subcommittee during Commercialization. The Marketing Subcommittee will review and comment upon the overall strategy and design of Gilead's marketing efforts under its Marketing Plans.

    5.3 Marketing Plan. No later than [*] before Gilead anticipates the first Commercial Launch of a Licensed Product anywhere in the Gilead Territory, Gilead will submit a plan detailing Gilead's projected activities to commercialize Licensed Products in the Gilead Territory including anticipated budgets (the "Marketing Plan"), to the Marketing Subcommittee. Thereafter, on or before each anniversary of the date of the first Commercial Launch of a Licensed Product, Gilead shall update, revise, and present to the Marketing Subcommittee the Marketing Plan. The Marketing Plan shall include a description of any anticipated activities of the MSLs. Cubist may comment upon each version of the Marketing Plan via its participation in the Marketing Subcommittee. Gilead reserves the right to modify its Marketing Plan at any time in response to (i) changes in [* ], (ii) [*], (iii) the feasibility of [*], (iv) changes in the [*] or (v) any failure [*], subject only to [*]to comment upon such changes and [*].

    5.4 Activities by MSLs in Gilead Territory.

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    5.5 Diligence Obligation. The Parties agree that the primary focus of their efforts to develop Licensed Products shall be upon IV Products and Oral Products. Gilead shall use Commercially Reasonable Efforts to Commercialize in the Gilead Territory both the IV Product, and an Oral Product if Cubist obtains Regulatory Approval for such a product in the United States and provides a clinical data package relating thereto that is sufficient to support Regulatory Approval in the Gilead Territory, in each case following Regulatory Approval of such Licensed Products in the Gilead Territory. Gilead shall require its Permitted Sublicensees in the Gilead Territory to use Commercially Reasonable Efforts to Commercialize such Licensed Products in the Gilead Territory following Regulatory Approval of such Licensed Products in the Gilead Territory. Whether Gilead is meeting such Diligence Obligation shall be determined with respect to each Licensed Product based upon all relevant factors, which may include without limitation the following factors:

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    In no event shall Gilead's Diligence Obligation with respect to any Licensed Product be deemed to include a requirement that Gilead [*] in any country.

    5.6 Determination of Gilead's Diligence. If Cubist believes that Gilead is not meeting its diligence obligation pursuant to Section 5.5 (such obligation, the "Gilead Diligence Obligation") with respect to any Licensed Product, Cubist shall notify Gilead. The Parties shall then proceed as provided in Sections 5.6(a) through (d) to determine Gilead's diligence in Commercializing Licensed Products. Gilead shall [* ] to Cubist's notice [*] with respect to such Licensed Product as well as [* ] of such Licensed Products within [*] of Gilead's receipt of such notice from Cubist. Cubist shall [*] with respect to such Licensed Product. If, after following the foregoing procedures in this Section 5.6, the Parties continue to disagree whether Gilead has met the Gilead Diligence Obligation with respect to such Licensed Product, the Parties shall [* ] Gilead's efforts to Commercialize such Licensed Product in the Gilead Territory (the "Discussion Period"). After such [* ]:

    5.7 Diversion of Resources for Directly Competitive Product.

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    5.8 Discounting. Neither Gilead, its Affiliates nor Permitted Sublicensees shall discount the price of Licensed Products in consideration of any price increase on, or the receipt of any payment in connection with, a product other than a Licensed Product, or shall enter into any agreement for such purpose.

    5.9 Gilead Compliance. In connection with any development activities undertaken by Gilead in connection with any Licensed Product, Gilead shall comply with all applicable laws and regulations regarding the care and use of experimental animals, as such laws and regulations are in effect where such development activities are undertaken. All animals used by Gilead to evaluate Daptomycin or any Licensed Product shall be provided humane care and treatment in accordance with the most acceptable veterinary practices.

ARTICLE 6
LICENSE; RIGHTS OF FIRST REFUSAL; EXCLUSIVITY

    6.1 Patent Licenses to Gilead. Subject to the terms and conditions of this Agreement, Cubist grants to Gilead an exclusive (even as to Cubist except to the extent provided below) license under the Cubist Patents: (i) [*] Licensed Products on a worldwide basis for the [*] Licensed Products in the Gilead Territory; (ii) to [*] Licensed Products in the Gilead Territory; and (iii) to develop (by conducting preclinical and clinical studies) Licensed Products on a worldwide basis for the [*] of Licensed Products within the Gilead Territory; provided, however, that Cubist shall retain the right, including the right to grant licenses and sublicenses, [*] Licensed Products on a worldwide basis for the [*] of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement, in the Gilead Territory, and to develop Licensed Products on a worldwide basis for the [*] of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement, in the Gilead Territory. Gilead may grant sublicenses under the foregoing license under Cubist Patents (A) for the purpose of [*] Licensed Products on a worldwide basis for the [*] of Licensed Products in the Gilead Territory, and (B) for such other purposes as Cubist may agree pursuant to Section 6.11. All such sublicenses are subject to the terms and conditions of this Agreement. In addition to any rights expressly retained by Cubist in the foregoing provisions of this Section 6.1, Cubist shall retain any and all rights in and to the Cubist Patents that are not expressly granted to Gilead pursuant to this Section 6.1.

    6.2 Patent Licenses to Cubist. Subject to the terms and conditions of this Agreement, Gilead grants to Cubist a non-exclusive license under the Gilead Project Patents: (i) to make and have made Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement including without limitation the Supply Agreement, in the Gilead Territory; (ii) to use, sell, offer for sale and import Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement including without limitation the Supply Agreement, in the Gilead Territory; and (iii) to develop Licensed

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Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement including without limitation the Supply Agreement, within the Gilead Territory. Cubist may grant sublicenses under the foregoing license under Gilead Project Patents. All such sublicenses are subject to the terms and conditions of this Agreement. Gilead shall retain any and all rights in and to the Gilead Project Patents that are not expressly granted to Cubist pursuant to this Section 6.2.

    6.3 Nonexclusive Know-How License to Gilead. Subject to the terms and conditions of this Agreement, Cubist grants Gilead a [*] to use Cubist Know-How solely for the purposes of: (i) making and having made (solely as provided in Article 7 and the Supply Agreement) Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products in the Gilead Territory; (ii) using, selling, offering for sale and importing Licensed Products in the Gilead Territory; and (iii) developing (by conducting preclinical and clinical studies) Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products in the Gilead Territory. Gilead may grant sublicenses under the foregoing license under Cubist Know-How for the purpose of making and having made (solely as provided in Article 7 and the Supply Agreement) Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products in the Gilead Territory and for such other purposes as Cubist may agree pursuant to Section 6.11. All such sublicenses are subject to the terms and conditions of this Agreement. Cubist shall retain any and all rights in and to the Cubist Know-How that are not expressly granted to Gilead pursuant to this Section 6.3.

    6.4 Nonexclusive Know-How License to Cubist. Subject to the terms and conditions of this Agreement, Gilead grants Cubist a royalty-free, non-exclusive, worldwide license, to use Gilead Know-How solely for purposes of (i) making and having made Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement, including without limitation the Supply Agreement, in the Gilead Territory; (ii) using, selling, offering for sale and importing Licensed Products outside the Gilead Territory and, solely pursuant to this Agreement, including without limitation the Supply Agreement, in the Gilead Territory; and (iii) developing Licensed Products on a worldwide basis for the use, sale, offering for sale and importation of Licensed Products outside of the Gilead Territory and, solely pursuant to this Agreement, including without limitation the Supply Agreement, within the Gilead Territory. Cubist may grant sublicenses under the foregoing license under Gilead Project Know-How. All such licenses are subject to the terms and conditions of this Agreement. Gilead shall retain any and all rights in and to the Gilead Project Know-How that are not expressly granted to Cubist pursuant to this Section 6.4.

    6.5 Rights of First Refusal and Negotiation.

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    6.6 Exclusivity.

    6.7 Trademark License. Cubist hereby grants Gilead an exclusive, royalty-free license under its entire right, title and interest in and to the Cubist Marks to use and display the Cubist Marks in connection with the Commercialization of Licensed Products within the Gilead Territory. Gilead hereby grants Cubist an exclusive, royalty-free license under its entire right, title and interest in and to the Gilead Marks to use and display the Gilead Marks in connection with the Commercialization of Licensed Products outside of the Gilead Territory. Each Party shall provide the other Party with copies of any materials containing such other Party's trademarks prior to using or disseminating such materials, and shall reasonably consider all comments made by such other Party regarding the use of its trademarks. Neither Party shall use the other Party's trade names and/or marks in a way which would be confusing or otherwise adversely affect their value. [*].

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    6.8 Third Party Technology.

    6.9 Sublicensed Technology.

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    6.10 Related Gilead Technology.

    6.11 Sublicensing. In addition to Gilead's rights to sublicense certain of its rights included in its licenses under the Cubist Patents and the Cubist Know-How pursuant to Sections 6.1 and 6.3 as provided for in such sections, [*] pursuant to this Section 6.11 shall be referred to herein as a "Permitted Sublicensee".

    6.12 Use of Patents and Know-How. Each Party covenants to the other that it will not practice the Patents or Know-How of the other Party except as expressly permitted in the licenses granted to it in this Article 6.

    6.13 Field. Notwithstanding anything in this Agreement to the contrary, it is acknowledged and agreed by the Parties that the licenses granted by Cubist to Gilead under this Agreement with respect to the Cubist Patents and Cubist Know-How that are licensed to Cubist pursuant to the Lilly License shall be solely for application to the treatment of [*].

ARTICLE 7
MANUFACTURE AND SUPPLY

    7.1 Supply by Cubist. As of the Effective Date, Cubist has established manufacturing arrangements for bulk Daptomycin and finished IV Products through Third Party suppliers (such Third Parties and any other Third Party supplier of Licensed Products to Cubist shall be referred to collectively as the "Cubist Suppliers"). Cubist shall supply to Gilead, and Gilead shall purchase from Cubist, (i) [*] in the Gilead Territory during the first five (5) years of the Term, and (ii) [*] of [*] in the Gilead Territory after the first [*] of the Term, in both cases on the terms and conditions to be set forth in a Supply Agreement to be added to this Agreement by addendum, which the Parties shall use their reasonable efforts in good faith to negotiate, execute and deliver within [*] days after the Effective Date (the "Supply Agreement"). Attached hereto as Exhibit G is a term sheet that sets forth certain of the terms that the Parties have agreed to incorporate into the Supply Agreement. Upon execution and delivery by the Parties of the Supply Agreement, the Supply Agreement shall supersede all of the terms and provisions of such term sheet.

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    7.2 Transfer Price.

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ARTICLE 8
COMPENSATION

    8.1 License Fee.

    Additionally, Gilead shall not [*] with respect to the development of an Oral Product [*], subject to Section 8.1(d).

    8.2 Milestone Payments. Subject to Section 14.2, in consideration for the licenses and exclusive rights of this Agreement, Gilead shall make milestone payments to Cubist based on achievement of IV Product development milestones as set forth in Section 8.2(a), and based on the achievement of Oral

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Product development milestones as set forth in Section 8.2(b). Gilead shall pay the amounts set forth below within [* ] after Gilead's receipt of notice from Cubist of the first achievement of the relevant milestone for an IV Product or an Oral Product, as documented by appropriate written and/or other materials. Each milestone payment by Gilead to Cubist hereunder shall be paid only once, and shall be noncreditable and nonrefundable.

Milestone Event
  Payment Amount
(in millions)
1.   [*] in the following clinical trials included in Exhibit A (defined as [*] for cSST; and either of the [*] for CAP.   [*]
2.   [*], Protocol Number [*].   [*]
3.   [*], Protocol Number [*]   [*]
4.   [*], Protocol Number [*].   [*]
5.   [*], Protocol Number [*].   [*]
6.   [*] for Endocarditis   [*]
7.   [*] for Endocarditis.   [*]
8.   Completion of the [*] of the following trials:   [*]
    • [*] for UTI    
    • [*] for Bacteremia    
    • [*] for Enterococcal Infection    
9.   [*] for the IV Product.   [*]
10.   [*]   [*]
11.   Patent issuing from [*] in a country within the Gilead Territory.   [*]

Total Potential IV Product Development Milestone Payments   [*]

    The Parties recognize that the clinical trials, protocol numbers and Primary Endpoints listed in the milestone events above may change as otherwise permitted pursuant to this Agreement. The milestone events as defined above shall be interpreted to apply to the modified clinical trial, protocol number and/or Primary Endpoint replacing that set forth above.

Milestone Event
  Payment Amount
(in millions)
1.   [*] for an Oral Product.   [*]
2.   [*] of an Oral Product.   [*]
3.   [*] of an Oral Product.   [*]
4.   [*] of an Oral Product.   [*]
5.   [*]   [*]

Total Potential Oral Product Development Milestone Payments   [*]

    8.3 Royalties.

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    8.4 Term of Royalties. Cubist's right to receive royalties under Section 8.3 shall expire on a country-by-country and product-by-product basis upon the later of (i) [*] from the Commercial Launch of such Licensed Product in such country; or (ii) expiration of the last to expire issued Cubist Patent containing a Valid Claim which would be infringed by the manufacture, use or sale in the Gilead Territory by Gilead of Licensed Product absent the license granted hereunder.

    8.5 Third Party Royalties and Other Payments. The royalties payable by Gilead to Cubist under Section 8.3 shall be [*] arising from license or other agreements entered into by Cubist prior to the Effective Date relating the manufacture, use, sale, offer for sale or importation of the Licensed Products, including without limitation [*]; provided, however, that nothing in this Section 8.5 shall limit the obligation of Gilead to [*] as contemplated by the Supply Agreement.

    8.6 Royalty Payments and Reports. All amounts payable to Cubist under this Agreement shall be paid in Dollars within [*] of the end of each calendar quarter except as otherwise specifically provided herein. Each payment of royalties owing to Cubist shall be accompanied by a statement, [*] of Licensed Product, [*] showing deductions provided for in Section 1.65 during such quarter, the [*] of Licensed Product and Net Sales during such quarter and on a [*] and the amount of royalty due on such sales. If any royalty reductions are claimed by Gilead under this Agreement from the full royalty rates set forth in Section 8.3, then the report shall set forth in detail the claimed reduction and the related facts.

    8.7 Taxes. Subject to the provisions of Section 8.7(b), Cubist shall be responsible for any and all taxes levied on account of amounts it receives under this Agreement.

    8.8 Blocked Currency. In any country where conversion of the local currency is blocked and such currency cannot be removed from the country, Gilead shall pay Cubist in local currency by deposit in a local bank designated by Cubist.

    8.9 Foreign Exchange. For the purpose of computing the Net Sales for Licensed Products sold in a currency other than Dollars, such currency shall be converted into Dollars as computed in the central Gilead currency conversion system using the average monthly rate of exchange at the time for such currencies as retrieved from the on-line edition of the Wall Street Journal (at http://www.interactive.wsj.com). The currency conversion system used by Gilead shall be subject to audit by Cubist as described in Section 12.1, and, if not determined to be a system reflecting a reasonable

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average exchange rate of the currencies in question, shall be modified as necessary to effect currency conversion at a reasonable average exchange rate.

    8.10 Payments to or Reports by Affiliates. Any payment required under any provision of this Agreement to be made to either Party or any report required to be made by any Party shall be made to or by an Affiliate of that Party if designated in writing by that Party as the appropriate recipient or reporting entity.

    8.11 Late Payments. Any amounts not paid by Gilead when due under this Agreement shall be subject to interest from and including the date payment is due through and including the date upon which Gilead has made a wire transfer of immediately available funds into an account designated by Cubist at a rate equal to [*] quoted in the Money Rates section of the on-line edition of the Wall Street Journal (at http://www.interactive.wsj.com) calculated daily on the basis of a 365-day year, or similar reputable data source, or, if lower, the highest rate permitted under applicable law.

ARTICLE 9
INTELLECTUAL PROPERTY

    9.1 Ownership of Inventions. Each Party shall own any inventions made solely by its employees or agents in their activities hereunder. Inventions hereunder 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.

    9.2 Prosecution of Patents.

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    9.3 Patent Term Extensions. Cubist will, [*], after discussing its strategy with Gilead and [*], in each country in the Gilead Territory, determine for which, if any, of the Patents within the Cubist Patents, Gilead Project Patents and Joint Patents, the Parties will apply to extend the patent term with respect to Licensed Products, as provided for in patent term extension laws or regulations in the Gilead Territory similar to the Patent Term Restoration Act or other similar laws and regulations affording an extension or restoration of patent terms in the United States, which similar laws and regulations shall include without limitation any Supplementary Protection Certificates. Cubist shall act with reasonable promptness in light of the development stage of Licensed Products to apply for any such extension. Gilead shall not make any submissions, filings or other communications with any governmental agency with respect to patent term restoration (or other similar grant of a monopoly right with respect to any Licensed Product) for any Patents within the Cubist Patents, Gilead Project Patents or Joint Patents in the Gilead Territory without Cubist's express consent. Gilead will cooperate fully with Cubist in making such filings [*] which may include without limitation, making available regulatory data and information.

    9.4 Non-Patent Regulatory Exclusivity. Gilead shall have the right to apply for regulatory exclusivity for the Licensed Products as provided in Section 4.7.

    9.5 Infringement of Patents by Third Parties.

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    9.6 Infringement of Third Party Rights.

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    9.7 Royalty Reduction. If Gilead is required (either by final judgment from a court of competent jurisdiction or pursuant to the terms of any settlement that complies with the provisions of Section 9.6(c) above) to pay a Third Party a royalty or make any payment of any kind for the right to practice the Cubist Technology in a particular country in the Gilead Territory and Cubist is required, [*], an amount [*] in respect of the [*]; provided, however, that nothing in this Section 9.7 shall relieve Cubist or Gilead from its obligations under Section 9.6 hereof.

    9.8 Patent Marking. Licensed Products marketed and sold by Gilead hereunder shall be marked with appropriate patent numbers or indicia at Cubist's request to the extent permitted by law, in those countries in which such markings have notice value as against infringers of patents.

    9.9 Selection and Registration of Product Trademarks. Gilead may select and own its own trademarks for use in connection with the sale of Licensed Products within the Gilead Territory, in addition to the Cubist-owned trademarks to which Gilead has a license pursuant to Section 6.7. Each Party shall be responsible for registering and maintaining its own trademarks, at its own expense.

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    9.10 Infringement of Trademarks by Third Parties. With respect to Licensed Products within the Gilead Territory, each Party shall notify the Steering Committee promptly upon learning of any actual, alleged or threatened infringement of any trademark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, or any such claims brought by a Third Party against a Licensed Product (hereinafter "TM Infringement"). Upon learning of such TM Infringement, the Steering Committee [*]. In the absence of other agreement [*], to bring an action to address such TM Infringement, in which case such Party [*].

    9.11 Patent Oppositions.

    9.12 Lilly License. Notwithstanding the foregoing, the Parties' rights and obligations under this Article 9 shall be subject to limitations imposed by the Lilly License, provided that the Parties shall work to address such limitations in a manner that permits Gilead to exercise its rights under this Agreement to the fullest extent reasonably possible.

ARTICLE 10
REPRESENTATIONS AND WARRANTIES

    10.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:

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    10.2 Cubist. Cubist represents and warrants to Gilead as follows:

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    10.3 Disclaimer. Gilead understands that Licensed Products are the subjects of ongoing clinical research and development and that Cubist cannot assure the safety or usefulness of Licensed Products. Cubist makes no warranty except as set forth in this Article 10 concerning its Patents or Know-How.

    10.4 No Other Representations. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS ARTICLE 10 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

ARTICLE 11
INDEMNIFICATION

    11.1 Indemnification by Cubist. Cubist hereby agrees to defend, hold harmless and indemnify (collectively "Indemnify") Gilead and its Affiliates, agents, directors, officers and employees (the "Gilead Indemnitees") from and against any and all suits, claims, actions, demands, liabilities, expenses and/or losses, including without limitation reasonable legal expenses and attorneys' fees (collectively "Losses") resulting directly or indirectly from (i) a breach of any of Cubist's representations and warranties pursuant to Article 10; (ii) any claims resulting directly or indirectly from the secondment of a Cubist MSL in the Gilead Territory other than to the extent arising directly from an action taken by a Cubist MSL in accordance with Gilead's specific instructions; or (iii) the development, use, sale, offer for sale or importation of Licensed Products by Cubist or its Affiliates, licensees or sublicensees; provided, however, that Cubist shall not be required pursuant to this Section 11.1 to indemnify the Gilead Indemnitees for any Section 9.6(d) Losses. Cubist's obligation to Indemnify the Gilead Indemnitees pursuant to this Section 11.1 shall not apply to the extent of any Losses (i) that arise from the negligence or intentional misconduct of any Gilead Indemnitee; (ii) from Gilead's breach of this Agreement, including without limitation the Supply Agreement; or (iii) for which Gilead is obligated to Indemnify the Cubist Indemnitees pursuant to Section 11.2 or the Supply Agreement. Cubist's obligations to indemnify Gilead with respect to the manufacture and supply of Licensed Product are set forth in the Supply Agreement.

    11.2 Indemnification by Gilead. Gilead hereby agrees to Indemnify Cubist and its Affiliates, agents, directors, officers and employees (the "Cubist Indemnitees") from and against any and all Losses resulting directly or indirectly from (i) a breach of any of Gilead's representations and warranties pursuant to Article 10; or (ii) the development, use, sale, offer for sale or importation of Licensed Products by Gilead or its Affiliates or sublicensees. Gilead's obligation to Indemnify the Cubist Indemnitees pursuant to the foregoing sentence shall not apply to the extent of any Losses (i) that arise from the negligence or intentional misconduct of any Cubist Indemnitee, (ii) for which Cubist is obligated to Indemnify the Gilead Indemnitees pursuant to Section 11.1, or (iii) from any breach by Cubist of this Agreement, including without limitation the Supply Agreement. Gilead's obligations to indemnify Cubist with respect to the manufacture and supply of Licensed Products are set forth in the Supply Agreement.

    11.3 Procedure. If either Party is seeking indemnification under Section 11.1 or 11.2 in connection with a Third Party claim, it shall inform the indemnifying Party of such Third Party claim giving rise to the obligation to indemnify pursuant to such section as soon as reasonably practicable after receiving notice of the claim. The indemnifying Party shall have the right to assume the defense of any such Third Party claim for which it is obligated to indemnify the indemnified Party under Section 11.1 or

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11.2. The indemnified Party shall cooperate with the indemnifying Party (and its insurer) as the indemnifying Party may reasonably request, and at the indemnifying Party's sole cost and expense. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party. Neither Party shall have any obligation to indemnify the other Party in connection with any settlement made without the indemnifying Party's written consent, provided that the indemnifying Party does not unreasonably withhold or delay any such written consent. If the Parties cannot agree as to the application of Sections 11.1 or 11.2 to any Third Party claim, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other in accordance with Section 11.1 or 11.2 upon resolution of the underlying claim.

    11.4 Insurance. Each Party shall procure and maintain insurance or self-insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Licensed Product is being clinically tested with human subjects or commercially distributed or sold by Gilead. It is understood that such insurance shall not be construed to create a limit of either Party's liability with respect to its indemnification obligations under this Article 11. Each Party shall provide the other with written evidence of such insurance (or financial information that describes the amounts available under any self-insurance facility) upon request. Each Party shall provide the other with written notice at least [*] prior to the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder.

    11.5 No Application to Third Party Infringement Claims. Except for the provisions of Section 11.4 above and Section 11.6 below, the provisions of this Article 11 shall not apply to any claims by a Third Party for infringement of such Third Party's patents or other intellectual property or to any Losses suffered or incurred by either Party arising from, or related to, any such claims by a Third Party. The indemnification rights and obligations of both Parties with respect to any such claims by a Third Party are provided for in Section 9.6(d) hereof.

    11.6 Limitation of Liability. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, INCLUDING WITHOUT LIMITATION IN THIS ARTICLE 11, AND EXCEPT FOR INFRINGEMENT BY EITHER PARTY OF THE OTHER PARTY'S INTELLECTUAL PROPERTY RIGHTS OR BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 13, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR LOST PROFITS OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES OF THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY (COLLECTIVELY, "OTHER DAMAGES"). IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR OTHER DAMAGES IN EXCESS OF [*] (THE "SECTION 11.6 CAP"). IT IS EXPRESSLY UNDERSTOOD THAT THE OBLIGATION OF EITHER PARTY UNDER ARTICLE 11 TO INDEMNIFY FOR AMOUNTS THAT THE OTHER PARTY ACTUALLY PAYS TO A THIRD PARTY SHALL NOT BE LIMITED BY THE SECTION 11.6 CAP.

ARTICLE 12
RECORDS; PUBLICATIONS

    12.1 Records. Each Party shall keep or cause to be kept such records as are required to determine, in a manner consistent with generally accepted accounting principles in the United States, the sums or credits due under this Agreement, including, but not limited to Incremental Product Development Expenses, Transfer Prices and Net Sales. At the request (and expense) of either Party, the other Party and its Affiliates and licensees and sublicensees shall permit an independent certified public accountant appointed by such Party and reasonably acceptable to the other Party, accompanied by representatives of the financial department of the audited Party at reasonable times, upon reasonable notice and no

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more frequently than once per calendar year, to examine only those records as may be necessary to determine, with respect to any calendar year ending not more than [*] prior to such Party's request, the correctness or completeness of any report or payment made under this Agreement. Results of any such examination shall be (i) limited to information relating to the Licensed Products, (ii) made available to both Parties, and (iii) subject to Article 13. The Party requesting the audit shall bear the full cost of the performance of any such audit, unless such audit discloses a variance of more than [*] from the amount of the original report, royalty or payment calculation. In such case, the Party being audited shall bear the full cost of the performance of such audit.

    12.2 Publications. Neither Party shall publish or present the results of studies carried out under this Agreement without the opportunity for prior review by the other Party. Subject to Section 13.2, each Party agrees to provide the other Party the opportunity to review any proposed abstracts, manuscripts or presentations (including verbal presentations) which relate to any Licensed Product at least [*] prior to their intended submission for publication and agrees, upon request, not to submit any such abstract or manuscript for publication, or to make such presentation, until the other Party is given a reasonable period of time to secure patent protection for any material in such publication or presentation which it believes to be patentable. Both Parties understand that a reasonable commercial strategy may require delay of publication or presentation of information or filing of patent applications. The Parties agree to review and consider delay of publication or presentation and filing of patent applications under certain circumstances. The Steering Committee will review such requests and recommend subsequent action. Neither Party shall have the right to publish or present Confidential Information of the other Party, and each Party shall remove the Confidential Information of the other Party from any proposed publication or presentation upon request by such other Party. Nothing contained in this Section 12.2 shall prohibit the inclusion of information necessary to file a patent application with a government authority, except for Confidential Information of the non-filing Party, provided the non-filing Party is given a reasonable opportunity to review the information to be included prior to submission of such patent application. Notwithstanding the foregoing, the Parties recognize that independent investigators have been engaged, and will be engaged in the future, to conduct clinical trials of Licensed Products. Independent investigators that have been engaged by a Party or both Parties prior to or on the Effective Date may release information regarding such studies in a manner consistent with academic standards within the scope of such investigator's agreement with the relevant Party. Independent investigators that are engaged by a Party or both Parties after the Effective Date are understood to operate in an academic environment and shall be allowed to release information regarding such studies in a manner consistent with academic standards; provided, however, that the Party in privity with such investigators shall discourage such disclosures if detrimental to the collaboration.

ARTICLE 13
CONFIDENTIALITY

    13.1 Treatment of Confidential Information. The Parties agree that during the Term, and for a period of [* ] after this Agreement expires or terminates, a Party receiving Confidential Information of the other Party shall (i) maintain in confidence such Confidential Information to the same extent such Party maintains its own proprietary industrial information of similar kind and value (but at a minimum each Party shall use commercially reasonable efforts to maintain Confidential Information in confidence); (ii) not disclose such Confidential Information to any Third Party without prior written consent of the disclosing Party, except for disclosures made in confidence to any Third Party pursuant to a plan approved by the Steering Committee or to its licensees or sublicensees who agree to be bound by obligations of non-disclosure and non-use at least as stringent as those contained in this Article 13; and (iii) not use such Confidential Information for any purpose except those purposes permitted by this Agreement.

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    13.2 Authorized Disclosure. Notwithstanding any other provision of this Agreement, each Party may disclose Confidential Information of the other Party:

    13.3 Publicity. The Parties agree that the joint public announcement of the execution of this Agreement shall be substantially in the form of the press release attached as Exhibit H. Any other publication, news release or other public announcement relating to this Agreement or to the performance hereunder, shall first be reviewed and approved by both Parties, which approval shall not be unreasonably withheld.

ARTICLE 14
TERM AND TERMINATION

    14.1 Term. This Agreement shall become effective on the Effective Date and shall remain in effect, unless earlier terminated pursuant to this Article 14 with respect to each Licensed Product until the expiration of the last royalty obligation relating to sales of such Licensed Product as provided in Article 8.

    14.2 Termination by Gilead. Gilead shall have, [*], the right to terminate this Agreement [*] upon [*] written notice to Cubist. If Gilead terminates this Agreement [*] Licensed Product pursuant to this Section 14.2, (i) Gilead shall provide Cubist with all reasonable assistance during the [*] notice period to effect the transfer of all regulatory activities, regulatory filings and Regulatory Approvals in the Gilead Territory for Licensed Product(s) as to which such termination is effective to Cubist, (ii) Cubist shall promptly wind down its efforts under any Proposed Modification to a protocol for a clinical trial being conducted by Cubist for such Licensed Product(s) pursuant to Section 3.4 that the Steering Committee approves, to the extent reasonably practicable without adversely affecting the value of the data to be obtained from such clinical trial to Cubist or compromising patient safety, and (iii) Gilead shall wind down its efforts to develop and commercialize such Licensed Product(s) in the Gilead Territory. Gilead shall continue to [*] pursuant to its [*] as to which this Agreement is terminated that is ongoing as of the date upon which Gilead provides a termination notice for such Licensed Product(s) pursuant to this Section 14.2, but Gilead shall not be responsible for [*] with respect to the Licensed Product(s) that are the subject of such trial. The Steering Committee shall oversee any such wind down efforts. Additionally, after termination of this Agreement pursuant to this Section 14.2, [*] with respect to which this Agreement is terminated prior to the effective date of such termination, but not for [*].

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    14.3 Termination for Breach.

    14.4 Cubist Rights upon Certain Terminations of the Agreement or as to Certain Licensed Products. If Cubist terminates this Agreement in its entirety or with respect to one or more Licensed Product(s) pursuant to Section 14.3, or Gilead terminates this Agreement in its entirety or with respect to any Licensed Products pursuant to Section 14.2 (such Licensed Products as to which Gilead or Cubist has terminated Gilead's rights, or all Licensed Products if the Agreement is terminated in its entirety, "Reverted Products"), then:

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    14.5 Gilead Rights upon Certain Terminations. If Gilead terminates this Agreement pursuant to Section 14.3 in its entirety or with respect to one or more Licensed Product(s), then [*] with respect to [*] for which [* ], shall [*] for so long as [*], except that [*] shall [*], without [*], and Gilead shall have no further obligations under this Agreement with respect to any such Licensed Product(s) other than [*], which shall last [*] as required by [*], and any other [*] that [*]. In addition, each Party's [*] with respect to [*] shall [*]. Gilead shall [*].

    14.6 Survival. The following provisions shall survive any expiration or termination of this Agreement for the period of time specified: Articles 11 (other than Section 11.4, and, subject to Section 14.5, only with respect to actions arising with respect to periods prior to termination), 12, 14, 15 and 16, and Sections 4.3 (but solely as necessary to effect the exchange of adverse events information in conjunction with Section 4.5), 4.5, 6.7 (but solely as to marks used in connection with Licensed Products during the Term), 7.2(e) (but only for [* ] beyond the end of the Term), 8.6 (but only for [*] and in relation to Net Sales made during the Term), 9.6(d) (subject to Section 14.5, with respect to actions arising with respect to periods prior to termination), 13.1 and 13.2, and in the case of any of the foregoing and other Section that by their terms explicitly survive beyond the Term, each such Section shall survive beyond the Term only for the length of time specified in such Section. The foregoing provisions that survive in the event of any expiration or termination of this Agreement shall survive in addition to those that survive any termination under Section 14.4 or 14.5, as specifically provided in such sections. Termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement nor prejudice either Party's right to obtain performance of any obligation. The remedies provided in this Article 14 are not exclusive of any other remedies a Party may have in law or equity.

    14.7 Clarification with respect to Supply Agreement. Upon The Parties' execution of the Supply Agreement, references to the Agreement in Sections 14.2, 14.3, 14.4, 14.5 and 14.6 shall be interpreted to apply to this Agreement and to the Supply Agreement as if they were one agreement.

    14.8 Repurchase of Inventory. Upon any termination of this Agreement by Gilead, Cubist shall have the obligation, upon request of Gilead, to repurchase all of the inventory of the Licensed Product held by Gilead or its sublicensees in the Gilead Territory, provided such inventory is in resalable condition. The price for such inventory shall be [*]. Gilead shall notify Cubist within [*] days after termination if Gilead wishes to have Cubist repurchase inventory and Cubist shall issue a return authorization to Gilead and Gilead shall ship the Licensed Product to Cubist [*]. If Gilead does not

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exercise its right to have Cubist repurchase inventory pursuant to this Section 14.8, Gilead shall have the right to sell out its inventory for a period of [*] from the date of termination.

ARTICLE 15
DISPUTE RESOLUTION

    15.1 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. 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 Section 15.1 if and when a dispute arises under this Agreement. All disputes arising under this Agreement shall be discussed first by the Steering Committee. If the Steering Committee is unable to resolve any dispute within [* ] after such dispute is submitted to it, either Party may, by written notice to the other Party, have such dispute referred to their respective executive officers designated below or their successors for attempted resolution by good faith negotiations within [*] after such notice is received. Such designated officers are as follows:

    If the designated officers are not able to resolve such dispute within such [*] period, either Party may at any time thereafter pursue any legal or equitable remedy available to it.

    15.2 Governing Law; Judicial Resolution. Resolution of all disputes arising out of or related to this Agreement or the performance, enforcement, breach or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of the State of New York, as applied to Agreements executed and performed entirely in the State of New York by residents of the State of New York, without regard to conflicts of law rules. Any dispute arising under this Agreement shall be submitted to a state or federal court of competent jurisdiction, except as otherwise expressly provided in this Agreement.

    15.3 Patent and Trademark Dispute Resolution. Any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any patent rights covering the manufacture, use or sale of any Licensed Product or of any trademark rights relating to any Licensed Product shall be submitted to a court of competent jurisdiction in the territory in which such patent or trademark rights were granted or arose.

    15.4 [*] Resolution of Certain Disputes. Issues relating to whether either Party is meeting its Diligence Obligations designated for resolution by a [*] pursuant to Section 3.5 or 5.6, modification of Section 1.29 with respect to Directly Competitive Product of an Oral Product, and whether Gilead has properly determined the amount of Promotional Resources under Section 5.7, shall be finally determined as set forth in this Section 15.4. Within [ *] after a Party proposes to submit an issue for resolution by a [*], each Party shall [*]. Neither of such [*] may be [*], and neither of such [*]. Within [*] days after expiration of such [*] period, the [*] shall [*] the issue(s) presented by the Parties. [*]. Each Party shall submit written materials to the other Party and to [*] relating to the matters in issue within [*] after [*]. Each Party shall then have [*] to submit a written rebuttal to the other Party's materials to the other Party [*]. The [*] shall decide the issue presented to them pursuant to Section 5.6, within [*] after they receive all such written materials from each Party. The [*] shall have the discretion to [*]. Each Party shall cooperate with [*]. The [*] determination shall be dispositive of all issues presented to it and such determination shall be given retroactive effect. Until such determination is delivered to the Parties, the Parties shall continue to perform their obligations under

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this Agreement in good faith and make any applicable payments accordingly. The Parties shall bear all expenses incurred pursuant to this Section 15.4 equally.

ARTICLE 16
MISCELLANEOUS

    16.1 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understandings between the Parties. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

    16.2 Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party uses reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the control of the Parties, including without limitation, an act of God, voluntary or involuntary compliance with any regulation, law or order of any government, war, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe; provided, however, the payment of invoices due and owing hereunder shall not be delayed by the payor because of a force majeure affecting the payor.

    16.3 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if mailed by first class certified or registered mail, postage prepaid, express delivery

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service or personally delivered, or if sent by facsimile, electronic transmission confirmed. Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below.

For Gilead:   Gilead Sciences, Inc.
333 Lakeside Drive,
Foster City, CA 94404
Attn: Vice-President of Corporate Development
Fax: (650) 522-5488
cc: General Counsel
Fax: (650) 522-5537

With a Copy to:

 

Cooley Godward LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, CA 94306
Fax: (650) 849-7400
Attention: Robert L. Jones, Esq.

For Cubist:

 

Cubist Pharmaceuticals, Inc.
24 Emily Street
Cambridge, Massachusetts 02139
Attention: Head of Corporate Development and Licensing
Fax: (617) 234-5592

With a Copy to:

 

Bingham Dana LLP
150 Federal Street
Boston, Massachusetts 02492
Attention: Julio E. Vega, Esq.
Fax: (617) 951-8736

    16.4 Maintenance of Records. Each Party shall keep and maintain all records required by law or regulation with respect to Licensed Products and shall make copies of such records available to the other Party upon request.

    16.5 No Strict Construction. This Agreement has been prepared jointly and shall not be strictly construed against either Party.

    16.6 Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party's consent to Affiliates or to a successor to substantially all of the business of such Party, whether in a merger, sale of stock, sale of assets or other transaction, and except to the extent provided in Section 10.06 of the Lilly License. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights and/or obligations. The Cubist Technology and the Gilead Project Technology shall exclude any intellectual property held or developed by a permitted successor of the relevant Party not in connection with Daptomycin Products. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 16.6 shall be null and void and of no legal effect.

    16.7 Performance by Affiliates. Each of Cubist and Gilead acknowledge that obligations under this Agreement may be performed by Affiliates of Cubist and Gilead. Each of Cubist and Gilead guarantee performance of this Agreement by its Affiliates. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities may not make

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decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.

    16.8 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

    16.9 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

    16.10 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

    16.11 Headings. The headings for each article and section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular article or section.

    16.12 No Waiver. Any delay in enforcing a Party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party's rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

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    IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their proper officers as of the Effective Date.

CUBIST PHARMACEUTICALS, INC.   GILEAD SCIENCES, INC.

By:

 

/s/ S. M. Rocklage

 

By:

 

/s/ John C. Martin
   
     
Title:   President & CEO   Title:   President & CEO
   
     
Date:   January 6, 2001   Date:   January 6, 2001
   
     

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EXHIBIT A


CUBIST CLINICAL TRIALS

Core Trials

  Protocol Number
and Trial Phase

  Country(ies) in which conducted
  Primary Endpoint
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
Other Trials            
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]

A–1



EXHIBIT B


CUBIST MARKS

Mark

  Country
  Filing Date
  Application
Number

[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]
[*]   [*]   [*]   [*]

B–1



EXHIBIT C


PRIMARY DAPTOMYCIN MOLECULE

[*]

C–1



EXHIBIT D


GILEAD MARKS

[*]

D–1



EXHIBIT E


COUNTRIES OF THE GILEAD TERRITORY

[*]

E–1



EXHIBIT F


COUNTRIES OF THE ROFR TERRITORY

[*]

F–1



EXHIBIT G


SUPPLY AGREEMENT
SUMMARY OF TERMS

[*]

    (4 pages of continuous text omitted here)

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EXHIBIT H


JOINT PRESS RELEASE

[CUBIST PHARMACEUTICALS LOGO]   LOGO
Contacts:    

Cubist Pharmaceuticals, Inc.

 

Gilead Sciences, Inc.

Jennifer LaVin

 

Susan Hubbard, Investors

Senior Director, Corporate Communications
(617) 576-4258

 

(650) 522-5715

jlavin@cubist.com

 

Amy Flood, Media
(650) 522-5643

Noonan/Russo Communications

 

 

Renee Connolly, Media

 

 

(212) 696-4455 ext. 227

 

 

renee@noonanrusso.com

 

 


CUBIST PHARMACEUTICALS AND GILEAD SCIENCES ANNOUNCE
EUROPEAN COMMERCIALIZATION AGREEMENT FOR
INVESTIGATIONAL ANTIBACTERIAL AGENT CIDECINTM

    Cambridge, MA and Foster City, CA, January 7, 2001—Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) and Gilead Sciences, Inc. (Nasdaq: GILD) today jointly announced the signing of a licensing agreement for the exclusive rights to commercialize Cubist's investigational antibacterial drug Cidecin™ (daptomycin for injection) and an oral formulation of daptomycin in 16 European countries following regulatory approval.

    Gilead has agreed to pay Cubist an up-front licensing fee of $13 million, and Cubist is entitled to receive additional cash payments of up to $31 million upon achievement of certain clinical and regulatory milestones. Gilead will also pay Cubist a fixed royalty on net sales. Cubist will continue to be responsible for worldwide clinical development of Cidecin, while Gilead will be responsible for any regulatory filings in the covered territories. Gilead's sales force will market the products in Europe. Cubist will provide European Medical Science Liaisons (MSLs) who will support the product by providing medical education services to infectious disease specialists and other international opinion leaders.

    "We believe Gilead to be the ideal European marketing partner for Cubist," said Scott M. Rocklage, Ph.D., Chairman, President and CEO of Cubist. "With its international sales force, Gilead is already calling on the identical target market for Cidecin. We believe this will be a synergistic relationship given that Gilead's product AmBisome and Cidecin are complementary in therapeutic focus, allowing for targeted marketing efforts to the same physician audiences. In addition, Gilead's

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proven track record of sales performance and experience with European regulatory authorities provides us with confidence in the company's ability to successfully market Cidecin to the European hospital community."

    Daptomycin is the first in a new class of investigational drugs called lipopeptides. Cubist is currently developing IV and oral formulations of daptomycin to treat serious bacterial infections. In vitro data show daptomycin has the ability to rapidly kill virtually all Gram-positive bacteria, including those resistant to current therapies. Cubist has multiple ongoing Phase III clinical trials of Cidecin, the IV formulation, to evaluate the efficacy and safety in the treatment of complicated skin and soft tissue infection (cSST), community-acquired pneumonia (CAP) and complicated urinary tract infection (cUTI). Phase II trial are also ongoing to investigate the treatment of bacteremia (BAC) and resistant infections (RRC). Cubist recently announced that it had completed enrollment in its international Phase III cSST trial and expects to announce clinical results during the second quarter of 2001. An oral version of daptomycin is currently in pre-clinical development.

    "Cidecin is an important addition to our portfolio of products for unmet medical needs," said John C. Martin, Ph.D., President and Chief Executive Officer of Gilead. "We believe Cidecin possesses a strong worldwide market potential and are pleased that Cubist has chosen Gilead as its European commercialization partner."

    Gilead markets AmBisome® (liposomal amphotericin B) for injection in 42 countries worldwide for the treatment of life-threatening systemic fungal infections. Since the product's European introduction in 1990, Gilead has successfully grown the market for Ambisome throughout the world. With total 1999 sales of $173 million, AmBisome is the second largest-selling injectable antifungal product worldwide. Much of the product's growth can be attributed to Gilead's efforts to increase the number of territories in which AmBisome is marketed, expand the product label through additional regulatory filings and inclusion of head-to-head competitive data, and maintain its well established marketing relationships.

    Cubist Pharmaceuticals is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Cubist is evaluating the safety and efficacy of Cidecin™ (daptomycin for injection) in the EDGE™ (Evaluation of Daptomycin against Gram-positive Entities) clinical trial program and is engaged in multiple, strategic partnerships, including Novartis Pharma AG, Merck & Co and Schering-Plough for the discovery and development of novel antiinfectives. Cubist recently completed the acquisition of TerraGen Discovery Inc., a private, natural products discovery company with operations in Vancouver, BC, Canada and Slough, UK.

    Gilead Sciences, headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. The Company discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA, Boulder, CO, San Dimas, CA, and Cambridge, UK, and sales and marketing organizations in the United States, Europe and Australia.

    Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist or Gilead. These factors include, but are not limited to: (i) the ability of Cubist to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the ability of Cubist and Gilead to obtain required governmental approvals; (iii) the ability of Cubist to attract and/or maintain manufacturing, sales, distribution and marketing partners; (iv) the ability of Cubist to develop and commercialize its

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products before its competitors; and (v) the ability of Gilead to grow or maintain the market for AmBisome particularly in light of the anticipated introduction of competitive products. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in each company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" for Cubist on Annual Report on Form 10-K/A (file No. 000-21379) filed on April 3, 2000 and for Gilead on Form 10-K for the year ended December 31, 1999.

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For additional information, visit either of the companies' web sites at
www.cubist.com or www.gilead.com.

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QuickLinks

ARTICLE 1 DEFINITIONS
ARTICLE 2 MANAGEMENT
ARTICLE 4 REGULATORY
EXHIBIT A
CUBIST CLINICAL TRIALS
EXHIBIT B
CUBIST MARKS
EXHIBIT C
PRIMARY DAPTOMYCIN MOLECULE
EXHIBIT D
GILEAD MARKS
EXHIBIT E
COUNTRIES OF THE GILEAD TERRITORY
EXHIBIT F
COUNTRIES OF THE ROFR TERRITORY
EXHIBIT G
SUPPLY AGREEMENT SUMMARY OF TERMS
EXHIBIT H
JOINT PRESS RELEASE
CUBIST PHARMACEUTICALS AND GILEAD SCIENCES ANNOUNCE EUROPEAN COMMERCIALIZATION AGREEMENT FOR INVESTIGATIONAL ANTIBACTERIAL AGENT CIDECINTM
For additional information, visit either of the companies' web sites at www.cubist.com or www.gilead.com .