-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D265d1dbZzmasyBrlxrEbKpZEHiDqZ99vmMGl9L0LaajYk30HX8NDOTMHRkXYjTI qXzURBA3++FrBYneiwNMwg== 0000950134-06-014716.txt : 20060803 0000950134-06-014716.hdr.sgml : 20060803 20060803170410 ACCESSION NUMBER: 0000950134-06-014716 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20060630 FILED AS OF DATE: 20060803 DATE AS OF CHANGE: 20060803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENELABS TECHNOLOGIES INC /CA CENTRAL INDEX KEY: 0000874443 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943010150 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-19222 FILM NUMBER: 061002795 BUSINESS ADDRESS: STREET 1: 505 PENOBSCOT DR CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 6503969500 MAIL ADDRESS: STREET 1: 505 PENOBSCOT DR CITY: REDWOOD CITY STATE: CA ZIP: 94063 10-Q 1 f22362e10vq.htm FORM 10-Q e10vq
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
     
þ   Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
for the quarterly period ended June 30, 2006.
or
     
o   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. 0-19222
GENELABS TECHNOLOGIES, INC.
(Exact name of Registrant as specified in its charter)
     
California   94-3010150
(State or other jurisdiction of   (I.R.S. employer identification number)
incorporation or organization)    
     
505 Penobscot Drive,   94063
Redwood City, California   (Zip code)
(Address of principal executive offices)    
Registrant’s telephone number, including area code: (650) 369-9500
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer o       Accelerated Filer o      Non-accelerated Filer þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
There were 24,050,331 shares of the Registrant’s Common Stock issued and outstanding on July 31, 2006.
 
 

 


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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II — OTHER INFORMATION
Item 1A. Risk Factors
Item 4. Submission of Matters to a Vote of Security Holders
Item 6. Exhibits
SIGNATURES
EXHIBIT INDEX
EXHIBIT 10.22
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1


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FORWARD-LOOKING STATEMENTS
     This quarterly report on Form 10-Q contains certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, referred to as the Exchange Act, which are subject to the “safe harbor” created therein, including those statements which use any of the words “may,” “will,” “anticipates,” “estimates,” “intends,” “believes,” “expects,” “plans,” “potential,” “seeks,” “goal,” “objective,” and similar expressions. These forward-looking statements include, among others, statements regarding:
    our ability to remain listed on the Nasdaq Capital Market;
 
    plans, programs, progress, and potential success regarding our collaborations and licenses, including those with Novartis Instititues for BioMedical Research, Inc. for non-nucleoside compounds targeting hepatitis C virus, Gilead Sciences, Inc. for nucleoside compounds targeting hepatitis C virus, GlaxoSmithKline for hepatitis E vaccine, and, for Prestara™, Watson Pharmaceuticals, Inc., Genovate Biotechnology Co., Ltd., and Tanabe Seiyaku Co., Ltd.;
 
    our ability, or our collaborators’ ability, to achieve any of the milestones contained in our agreements;
 
    plans, programs, progress, and potential success regarding our research efforts, including our ability to identify compounds for preclinical development and the success of any such preclinical development efforts in our hepatitis C and other research programs;
 
    further actions or developments relating to Prestara (prasterone), our investigational drug for lupus, and its New Drug Application;
 
    our future cash resources, expenditures and our ability to obtain additional funding for our business plans; and
 
    the securing and defense of intellectual property rights important to our business.
     All statements in this quarterly report on Form 10-Q that are not historical are forward-looking statements and are subject to risks and uncertainties, including those set forth in the Risk Factors section in Item IA of Part II. Among these are the risks that we may be delisted from the Nasdaq Capital Market, that our research programs may fail, that problems with our manufacturers or collaborators may negatively impact their or our research, clinical trials or product manufacture, development or marketing, that our attempts to license our technologies to others may fail and that clinical trials of Prestara™ or similar formulations of prasterone are abandoned, delayed, or have results that are negative, inconclusive or not usable to support regulatory approval, that the U.S. Food and Drug Administration, or FDA, and foreign authorities may delay or deny approval of Prestara™. These as well as other factors may also cause actual results to differ materially from those projected and expressed or implied in these statements. We assume no obligation to update any such forward-looking statement for subsequent events. The risks and uncertainties under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained herein, among other things, should be considered in evaluating our prospects and future financial performance. All forward-looking statements included in this quarterly report on Form 10-Q are made as of the date hereof.

 


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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
GENELABS TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
                 
    June 30,     December 31,  
    2006     2005  
    (Unaudited)     (Note 1)  
ASSETS
Current assets:
               
Cash and cash equivalents
  $ 23,417     $ 10,061  
Restricted cash
          150  
Accounts receivable
    355       29  
Other current assets
    402       510  
 
           
Total current assets
    24,174       10,750  
Property and equipment, net
    788       951  
Long-term investment
    960       960  
Restricted cash
    150        
 
           
 
  $ 26,072     $ 12,661  
 
           
 
               

LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
               
Accounts payable and other accrued liabilities
  $ 807     $ 608  
Accrued compensation and related expenses
    1,082       789  
Accrued manufacturing costs
    675       675  
Unearned contract revenue
    8,286       3,220  
 
           
Total current liabilities
    10,850       5,292  
Accrued compensation
    189       284  
Unearned contract revenue
    11,427       4,738  
 
           
Total liabilities
    22,466       10,314  
 
           
Commitments and contingencies
               
Shareholders’ equity:
               
Common stock
    240,003       231,057  
Accumulated deficit
    (236,397 )     (228,710 )
 
           
Total shareholders’ equity
    3,606       2,347  
 
           
 
  $ 26,072     $ 12,661  
 
           
See notes to condensed consolidated financial statements.

 


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GENELABS TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
                                 
    For the three months ended     For the six months ended  
    June 30,     June 30,  
    2006     2005     2006     2005  
Revenue:
                               
Contract
  $ 2,156     $ 1,553     $ 3,711     $ 3,108  
Royalty
    163       157       313       324  
 
                       
Total Revenue
    2,319       1,710       4,024       3,432  
 
                       
 
                               
Operating expenses:
                               
Research and development
    4,058       3,219       7,647       6,481  
General and administrative
    2,656       1,499       4,253       2,920  
 
                       
Total operating expenses
    6,714       4,718       11,900       9,401  
 
                       
 
                               
Operating loss
    (4,395 )     (3,008 )     (7,876 )     (5,969 )
Interest income, net
    98       123       189       243  
 
                       
 
                               
Net loss
  $ (4,297 )   $ (2,885 )   $ (7,687 )   $ (5,726 )
 
                       
 
                               
Net loss per common share – basic and diluted
  $ (0.24 )   $ (0.16 )   $ (0.43 )   $ (0.32 )
 
                       
 
                               
Weighted average shares outstanding to calculate basic and diluted net loss per common share
    17,886       17,702       17,852       17,701  
 
                       
See notes to condensed consolidated financial statements.

 


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GENELABS TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(In thousands)
(Unaudited)
                 
    For the six months ended  
    June 30,  
    2006     2005  
Cash flows from operating activities:
               
Net loss
  $ (7,687 )   $ (5,726 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization expense
    204       210  
Share-based compensation expense
    537       6  
Changes in assets and liabilities:
               
Accounts receivable
    (326 )     (28 )
Other current assets
    108       491  
Accounts payable, accrued liabilities and accrued compensation
    397       (1,916 )
Unearned contract revenue
    11,755       (1,310 )
 
           
Net cash provided by/(used in) operating activities
    4,988       (8,273 )
Cash flows from investing activities:
               
Purchase of property and equipment
    (41 )     (187 )
Cash flows from financing activities:
               
Proceeds from issuance of common stock and warrants, net
    8,409       174  
 
           
Net increase/(decrease) in cash and cash equivalents
    13,356       (8,286 )
Cash and cash equivalents, beginning of the period
    10,061       26,358  
 
           
Cash and cash equivalents, end of the period
  $ 23,417     $ 18,072  
 
           
See notes to condensed consolidated financial statements.

 


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GENELABS TECHNOLOGIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Tabular amounts in thousands, except per share data)
(Unaudited)
June 30, 2006
1.   Significant Accounting Policies
     Business Description
     Genelabs Technologies, Inc., referred to as Genelabs or the Company, is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. The Company has built drug discovery capabilities that can support various research and development projects. The Company is currently concentrating these capabilities on discovering novel compounds that selectively inhibit replication of the hepatitis C virus (HCV) and advancing preclinical development of compounds from this HCV drug discovery program, while also developing a late-stage product for lupus.
     Basis of Presentation
     The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Accelerated Clinical Research Organization, Inc., Genelabs Diagnostic, Inc. and Genelabs Europe B.V. All intercompany accounts and transactions have been eliminated. Genelabs operates in one business segment, the discovery and development of pharmaceutical products.
     The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual amounts may differ from those estimates.
     These financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three-month and six-month periods ended June 30, 2006 are not necessarily indicative of the results that may be expected for the year ending December 31, 2006. These unaudited condensed consolidated financial statements are meant to be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2005. The comparative balance sheet as of December 31, 2005 has been derived from the audited financial statements at that date.
     Certain prior period amounts have been reclassified to conform to the current presentation.
2.   Stock-Based Compensation
     In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (SFAS 123R), which changes the accounting for share-based payment awards under our stock option and stock purchase plans, eliminating the ability to account for awards to employees using the intrinsic value method, which had been used by the Company through December 31, 2005. Instead, SFAS 123R requires that awards be

 


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accounted for using a fair-value based method, and the Company is now required to recognize a share-based compensation expense based on estimates of the value of the awards.
     Under SFAS 123R, share-based compensation expense is measured at the grant date, based on the estimated fair value of the award. The portion of the expense related to awards that are ultimately expected to vest is recognized on a straight line basis over the related employees’ requisite service periods in our Condensed Statement of Operations. The Company has no awards with market or performance conditions.
     The Company adopted SFAS 123R effective January 1, 2006 using the modified prospective transition method. Under the modified prospective application, prior periods are not restated to reflect the impact of SFAS123R for comparative purposes. The valuation provisions of SFAS 123R apply to new awards and to awards that are outstanding on the effective date and subsequently modified or cancelled. Estimated compensation expense for awards outstanding at the effective date will be recognized over the remaining service period using the compensation cost calculated for pro forma disclosure purposes under FASB Statement No. 123, “Accounting for Stock-Based Compensation” (SFAS 123).
     Employee Stock Plans
     Employee Stock Purchase Plan. Employees who meet certain minimum requirements are eligible to participate in the Company’s Employee Stock Purchase Plan. Eligible employees are entitled to purchase stock at 85% of the market value at the beginning or ending of six-month purchase periods, whichever is lower, and stock may be purchased at the same price for up to four periods. Employees can contribute up to 15% of total compensation, but purchases are limited to a maximum of $25,000 per year. At June 30, 2006, 298,000 shares were available for future purchases.
     Stock Option Plan. The Company’s stock option plan provides for the issuance of incentive stock options and nonqualified stock options to employees, officers, directors and independent contractors. The number of stock options granted is determined by the Board of Directors or a committee designated by the Board of Directors, except for grants to directors, who receive options based on a formula. Stock options generally are not granted at prices lower than fair market value on the date of grant and vest over periods ranging up to four years, with expiration no later than ten years from the date of grant. At June 30, 2006, 349,000 shares were available for future grants.
     Share-Based Compensation Information under SFAS 123R (beginning January 1, 2006)
     Under the provisions of SFAS 123R, the Company has elected to continue using the Black-Scholes option-pricing model (Black-Scholes model) as its method of valuation for share-based payment awards. Because the Company’s historical data demonstrated different patterns of exercise behavior for officers as compared to non-officer employees, upon adoption of SFAS 123R the Company has elected to value its options separately for officers and non-officers.
     The weighted-average estimated fair value of shares granted under the Stock Option Plan during the six months ended June 30, 2006 was $1.51 and $1.44 per share for officers and non-officers, respectively, using the Black-Scholes model with the following weighted-average assumptions (annualized percentages) for the three and six months ended June 30, 2006:
                 
            Employees
            who are
            not
    Officers   Officers
     
Risk-free interest rate
    4.5 %     4.5 %
Dividend yield
    0.0 %     0.0 %
Expected volatility
    90.0 %     90.0 %
Expected term (years)
    6.75       5.75  

 


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     The expected dividend yield, volatility and term above were determined by the Company based upon the historical behavior of option holders, historical fluctuations in the market price of the Company’s stock over a period similar to the expected terms of the options, historical dividend payments and the expectations of Company management regarding these factors. The risk-fee interest rate assumption is based upon observed interest rates appropriate for the expected life of the Company’s employee stock options. Substantially all of the options issued in the first half of 2006 were issued in the first quarter of 2006.
     As share-based compensation expense for stock options recognized in the Consolidated Statement of Operations for the six months ended June 30, 2006 is based on awards ultimately expected to vest, the share-based compensation expense related to stock options has been reduced for estimated forfeitures. SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Future forfeitures of vested and unvested employee stock options outstanding are estimated by the Company to be approximately 4.1% and 10.6% per year for officers and non-officers, respectively.
     The weighted average estimated fair value of each share assumed to be purchased under our stock purchase plan for the purposes of calculating stock-based compensation expense was $0.88 for all participating employees based upon the following weighted average assumptions (annualized percentages) for the three and six months ended June 30, 2006:
         
Risk-free interest rate
    4.4 %
Dividend yield
    0.0 %
Expected volatility
    90.0 %
Expected term (years)
    1.2  
     All assumptions used in determining the weighted-average estimated fair value of share-based payment awards and the related share-based compensation expense for the periods presented are subject to substantial change in the future.
     Total share-based compensation expense related to all of the Company’s share based awards was included in the statement of operations as follows:
                 
    For the three months     For the six months  
    ended June 30, 2006     ended June 30, 2006  
Research and development
  $ 217     $ 419  
General and administrative
    60       118  
 
           
Total share-based compensation expense
  $ 277     $ 537  
 
           
 
               
Effect on net loss per common share, basic and diluted
  $ (0.02 )   $ (0.03 )
 
           
     Share-based compensation expense for the six months ended June 30, 2006 includes $171,000 related to share-based awards granted during the six months ended June 30, 2006. As of June 30, 2006, total compensation cost related to non-vested stock options not yet recognized was $1.1 million, which will be expensed over a weighted average period of 1.4 years.

 


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     Stock Option Activity
     Stock option transactions for the first half of 2006 are summarized as follows:
                                 
            Weighted     Weighted        
            Average     Average     Aggregate  
    Number     Exercise     Remaining     Intrinsic  
    of Shares     Price     Term     Value  
     
Outstanding at December 31, 2005
    1,746     $ 9.73                  
Granted
    567     $ 1.88                  
Exercised
        $                  
Canceled
    (110 )   $ 15.54                  
 
                             
Outstanding at June 30, 2006
    2,203     $ 7.41     7.4 years   $  
 
                             
Exercisable at June 30, 2006
    1,249     $ 10.88     5.9 years   $  
     The SFAS 123 fair value of the approximately 185,000 options that vested during the six months ended June 30, 2006 was $918,000 at a weighted average value of approximately $4.95 per share.
     Pro-Forma Information under SFAS 123 (for periods prior to January 1, 2006)
     Prior to adopting the provisions of SFAS 123R, the Company applied APB Opinion No. 25 “Accounting for Stock Issued to Employees” in accounting for its share based payment awards. The Company grants employee stock options at an exercise price equal to the fair market value of the shares at the date of grant and, accordingly, recognized no compensation expense for awards to employees. The Company followed the disclosure only provisions of SFAS 123, as amended by SFAS No. 148. The following table presents information showing the effects to the reported net loss and net loss per share if Genelabs had accounted for employee awards using the fair-value method:
                 
    For the three     For the six  
    months ended     months ended  
    June 30, 2005     June 30, 2005  
Net loss as reported
  $ ( 2,885 )   $ ( 5,726 )
Stock-based employee compensation cost:
               
Included in net loss as reported
           
Amount that would have been included in net loss if we had accounted for all stock- based employee compensation at its theoretical fair value
    ( 290 )     ( 664 )
 
           
Pro forma net loss
  $ ( 3,175 )   $ ( 6,390 )
 
           
 
               
Net loss per common share as reported, basic and diluted
  $ (0.16 )   $ (0.32 )
 
           
Pro forma net loss per common share, basic and diluted
  $ (0.18 )   $ (0.36 )
 
           
3.   Comprehensive Loss
     During each of the three and six month periods ending June 30, 2006 and 2005, the Company’s comprehensive loss was the same as its net loss.
4.   Net Loss per Share
     Net loss per share has been computed using the weighted average number of shares of common stock outstanding during the period. Had the Company been in a net income position, diluted earnings per share for both the three months ended June 30, 2006 and 2005 would have included an additional 1,000

 


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shares and for both the six months ended June 30, 2006 and 2005 would have included an additional 2,000 shares related to the Company’s outstanding stock options and warrants as determined under the treasury stock method.
5.   License and Collaboration Agreement with Novartis
     On June 2, 2006, the Company entered into a license and collaboration agreement with the Novartis Institutes for BioMedical Research for the development and commercialization of compounds from Genelabs’ HCV non-nucleoside drug discovery program. The Company has received a nonrefundable up-front payment of $12.5 million and is entitled to additional research funding of approximately $7.5 million over the next two years for work performed on the collaboration. In addition, if all potential clinical, regulatory and sales milestones are met, additional payments to Genelabs could exceed $175 million. Genelabs is also entitled to a royalty on net sales of products covered by the collaboration.
     Upon receipt, the Company recorded the up-front payment from Novartis as unearned contract revenue, classified as a liability in the consolidated balance sheet, and is recognizing this unearned contract revenue into contract revenue in the statement of operations on a straight-line basis over the three-year term of Genelabs’ potential obligations. The three-year term consists of the initial two-year term of the research collaboration plus a one-year term that Novartis has as an option to extend the collaboration. In the second quarter of 2006 Genelabs recognized revenue of $0.6 million under the agreement.
6.   Private Placement Financing
     On June 30, 2006, Genelabs completed the sale of 6.1 million shares of its common stock and warrants to purchase 2.5 million shares of its common stock for gross proceeds of $9.0 million. The warrants have an exercise price of $1.42 per share and a term of five years. Net proceeds from the placement were approximately $8.3 million.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
     All statements in Management’s Discussion and Analysis of Financial Condition and Results of Operations that are not historical are forward-looking statements. All estimates for periods later than June 30, 2006 of costs, expenses, revenue, savings, future amortization periods and other items are forward-looking statements. Statements regarding possible actions or decisions in periods ending after June 30, 2006 by Genelabs and other parties, including collaborators and regulatory authorities, are forward-looking statements. Actual results may differ from the forward-looking statements due to a number of risks and uncertainties that are discussed under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Shareholders and prospective investors in the Company should carefully consider these risk factors. We disclaim any obligation to update these statements for subsequent events.
     Genelabs Technologies, Inc., referred to as Genelabs or the Company, is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. The Company has built drug discovery capabilities that can support various research and development projects. The Company is currently concentrating these capabilities on discovering novel compounds that selectively inhibit replication of the hepatitis C virus, or HCV, and advancing preclinical development of compounds from this hepatitis C virus drug discovery program, while also exploring options for development of a late-stage product for lupus.

 


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     A number of events have impacted the business of Genelabs during 2006.
     On April 4, 2006, we received a notice from The Nasdaq Stock Market, or Nasdaq, stating that we did not meet the Nasdaq Capital Market continued listing requirements, which require a minimum of $2.5 million in shareholders’ equity or a market capitalization of $35 million, among other things. We responded to Nasdaq with our plan to regain compliance with their requirements, but on May 16, 2006 Nasdaq sent us a letter stating that our securities would be delisted. We filed an appeal of Nasdaq’s determination to delist our securities and subsequently attended an oral hearing before a Nasdaq Listings Qualification Panel. At the oral hearing we provided the Panel with financial information showing our compliance with the Nasdaq Capital Market continued listing requirement for shareholders’ equity as of June 30, 2006. To date we have not received a decision from the Panel regarding the delisting of our securities.
     On June 2, 2006, we entered into a license and collaboration agreement with the Novartis Institutes for BioMedical Research for the development and commercialization of compounds from Genelabs’ HCV non-nucleoside drug discovery program. We have received a nonrefundable up-front payment of $12.5 million and are entitled to additional research funding of approximately $7.5 million over the next two years for work performed on the collaboration. In addition, if all potential clinical, regulatory and sales milestones are met, we could receive additional payments in excess of $175 million. We are also entitled to a royalty on net sales of products covered by the collaboration. The $12.5 million up-front payment has been recorded as unearned contract revenue, classified as a liability in our consolidated balance sheet, and we plan to record it into contract revenue on a straight-line basis over a three-year period. During both the three-month and six-month periods ended June 30, 2006, we recognized $0.6 million in revenue under the collaboration with Novartis, which comprises a portion of the up-front payment and additional funds that are due from Novartis as a result of work performed on the program in the second quarter of 2006.
     On June 30, 2006, we completed the sale of 6.1 million shares of our common stock and warrants to purchase 2.5 million shares of our common stock for gross proceeds of $9.0 million. Net proceeds from the placement were approximately $8.3 million.
     Effective January 1, 2006, Genelabs adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment”, or SFAS 123R, which changes the accounting for share-based payment awards under our employee stock option and purchase plans. Under SFAS 123R we are required to recognize compensation expense based on estimates of the value of the share-based awards. Genelabs adopted SFAS 123R using the modified prospective transition method, an adoption method under which prior periods are not restated to reflect the impact of FAS123R for comparative purposes. Under SFAS 123R, the total share-based compensation expense recognized for the three-month and six-month periods ended June 30, 2006 was $0.3 million, or approximately $0.02 per share, and $0.5 million, or approximately $0.03 per share, respectively. Prior to the adoption of SFAS 123R, Genelabs followed the disclosure only provisions of SFAS 123, as amended by SFAS 148, and accordingly did not recognize expense for employee stock option and purchase plans in its statement of operations.
Results of Operations – Second Quarter 2006 compared to Second Quarter 2005
     Summary
     Genelabs’ net loss was $4.3 million in the second quarter of 2006 compared to a net loss of $2.9 million for the second quarter of 2005. The higher net loss in the 2006 period compared to the 2005 period is primarily due to:
    increased general and administrative expenses for financial advisory and other fees related to the collaboration with Novartis;

 


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    increased drug discovery expenses for our HCV drug discovery programs, including preclinical development costs for the non-nucleoside program prior to the licensing agreement with Novartis;
 
    increased expenses for our employee incentive-based-compensation program after we met board-specified criteria resulting in the removal of payment contingencies; and
 
    increased expenses upon the adoption of a new accounting standard that requires recording the estimated value of stock-based compensation in the statement of operations.
Partially offsetting the above increases in our net loss were:
    lower expenses for the development of Prestara™, our investigational new drug for lupus and
 
    higher revenue as a result of the collaboration with Novartis.
     Revenue
     Contract revenue was $2.2 million in the second quarter of 2006 compared to $1.6 million in the second quarter of 2005. The $0.6 million increase in contract revenue in the second quarter of 2006 was the result of revenue recognized under our recent collaboration with Novartis, for which there is no comparable revenue in 2005. In the second quarters of both 2006 and 2005, we also recognized $1.4 million in revenue under our collaboration with Gilead Sciences, Inc., or Gilead. The collaborations with both Novartis and Gilead included non-refundable up-front payments to Genelabs, which are being recognized into revenue over the term of our expected obligations under the respective agreements. The collaborations also include quarterly payments to Genelabs during the term of our research obligations to our collaborators, which we recognize into revenue as earned.
     Also during the second quarter of both 2006 and 2005, we recognized $0.2 million in revenue from our two collaborations for development and commercialization of our investigational new drug for lupus, Prestara™. The collaborations are with Watson Pharmaceuticals, Inc., or Watson, for North America and Tanabe Seiyaku Co., Ltd., or Tanabe, for Japan, and the revenue that we recognize under these agreements represents previously received up-front payments which we deferred and are recognizing over the term of our expected obligations, which we presently estimate to be through December 31, 2008. The estimates regarding the amortization period for the agreements with Watson and Tanabe are subjective and could change in the future based on discussions with corporate partners, the status of the clinical trial design and the response of the FDA, among other things.
     Royalty revenue was $0.2 million in the second quarter of both 2006 and 2005.
     Research and Development Expenses
     Because we are in the business of drug discovery and development and have not developed any products that have been approved for sale, the majority of our resources are devoted to these discovery and development efforts, and accordingly, most of our costs are classified as research and development and expensed as incurred. Research and development expenses include related salaries and benefits, supplies and chemicals used in laboratories, preclinical and clinical trials, product manufacturing costs, contract and outside service fees, and allocated facilities and overhead costs. The majority of Genelabs’ research and development is directed toward discovery of new drugs targeting HCV, although we are also continuing work on the design of a new phase III clinical study of Prestara™ as an investigational new drug for lupus. The following table shows our research and development expenses by major category (in thousands):

 


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    For the three months ended    
    June 30,    
    2006   2005   Change
     
Drug discovery (HCV)
  $ 1,908     $ 1,544       +24 %
Drug development (Prestara™)
    358       711       -50 %
Support costs and other research and development
    1,792       964       +86 %
             
Total research and development
  $ 4,058     $ 3,219       +26 %
             
     Research and development expenses increased by $0.8 million in the second quarter of 2006 compared to the second quarter of 2005. Expenses for drug discovery comprise the largest category of our research and development expenses. Drug discovery costs increased by $0.4 million in the second quarter of 2006 compared to the second quarter of 2005 primarily as a result of continued growth in our HCV drug discovery programs, including an increase in the number of scientists we have working on our programs. In addition, we entered into a new contract for optimizing the synthesis route and scale-up manufacturing for one of our HCV preclinical candidates and we conducted additional external preclinical studies. Drug development costs for Prestara, our investigational drug for lupus, were $0.4 million lower in the second quarter of 2006 than in the second quarter of 2005 as a result of our completion of an open-label follow-on study in 2005 and a significantly lower number of employees working on the program in 2006. We expect that we will continue to have lower spending on Prestara for the foreseeable future. Support costs and other research and development costs were $0.8 million higher in the second quarter of 2006 than in the second quarter of 2005. These costs are primarily those associated with maintaining our research and development facility such as rent, insurance, depreciation, utilities, maintenance and security as well as the cost of support staff, the company bonus and, for the second quarter of 2006, stock-based compensation. These costs are allocated based on relative headcount between research and development and general and administrative employees. These support costs and other research and development expenses increased in the second quarter of 2006 compared to the second quarter of 2005 due to higher costs recorded for our employee incentive bonus compensation program following our meeting key objectives in 2006 and the charge for stock-based compensation in 2006.
     Since initiating our first drug discovery program in 1993, Genelabs has built medicinal chemistry, combinatorial chemistry, computational modeling, molecular biology, assay development and high-throughput screening, drug metabolism, pharmacokinetics and toxicology capabilities. Genelabs has incurred direct drug discovery costs of approximately $48 million through June 30, 2006. Of this amount, $20 million relates to our HCV drug discovery programs which began in early 2002. During 2006, substantially all of our drug discovery efforts were directed toward three separate HCV research programs, which are concentrated on identifying a new drug to combat infection with HCV. Two of these programs target the HCV NS5b RNA-dependent RNA polymerase (the enzyme directly responsible for replication of the HCV genome), although through different mechanisms. We refer to one of these mechanisms as our nucleoside program and we refer to the other as the non-nucleoside program. Our third HCV drug discovery program targets the HCV NS5a protein, a different viral enzyme that is also required for viral replication. Part of our drug discovery process includes continued testing of our preclinical drug candidates and identification of additional potential lead compounds. Genelabs also began developing Prestara™ for systemic lupus erythematosus in 1993 when we licensed exclusive rights to patents related to Prestara from Stanford University. To potentially develop this investigational new drug we have incurred direct costs of approximately $50 million through June 30, 2006.
     Due to the nature of drug discovery research and drug development, we cannot reliably estimate the outcome of scientific experiments, many of which will impact the design and conduct of subsequent scientific experiments, and all of which provide additional information on both the direction of the research program and likelihood of its success. As such, the potential timing for key future events that may occur in our drug discovery and development programs cannot reliably be estimated and we cannot estimate whether a compound will advance to a later stage of development or when we may determine that a program is no longer viable for potentially producing a drug candidate. We also cannot reasonably predict the costs to reach these stages, and cannot predict whether any of our compounds will result in commercial products or lead to revenue for the Company. Going forward, we believe two of our HCV polymerase-targeted

 


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programs, nucleoside and non-nucleoside, are staffed at appropriate levels to address our objectives. We plan to further expand our efforts on our NS5a program as this program has reached a stage where it will require additional resources. We believe that our costs will increase as we hire additional scientists for this program. During 2006, we also intend to explore other drug targets as potential programs as we have done previously. However, outcomes of current and planned scientific experiments and outcomes of corporate partnering discussions may cause us to revise these estimates. Management continually evaluates the status of our drug discovery research and our drug development programs and expects to continue to devote resources toward these efforts, while at the same time managing the level of expenditures to balance limited cash resources and the various drug discovery and development opportunities.
     General and Administrative Expenses
     General and administrative expenses were $2.7 million in the second quarter of 2006 compared to $1.5 million in the second quarter of 2005. Our general and administrative expenses consist primarily of personnel costs for executive management, finance, marketing, business development, human resources and legal departments, as well as professional expenses, such as legal and audit, and allocated facilities costs such as rent and insurance. In the second quarter of 2006, our general and administrative expenses also included a fee we paid to Lazard, a financial advisor, related to the collaboration with Novartis. Other increases in the second quarter of 2006 compared to the second quarter of 2005 included higher legal expenses for patents and business development activities, including those related to the agreement with Novartis, higher charges for the employee incentive bonus program and a charge for stock-based compensation.
Results of Operations – First Six Months of 2006 compared to First Six Months of 2005
     Summary
     Genelabs’ net loss was $7.7 million for the first six months of 2006, compared to a net loss of $5.7 million for the first six months of 2005. The higher net loss in the 2006 period compared to the 2005 period is primarily due to:
    increased general and administrative expenses for financial advisory and other fees related to the collaboration with Novartis;
 
    increased drug discovery expenses for our HCV drug discovery programs, including preclinical development costs for the non-nucleoside program prior to the licensing agreement with Novartis;
 
    increased expenses for our employee incentive-based-compensation program after we met board-specified criteria resulting in the removal of payment contingencies; and
 
    increased expenses upon the adoption of a new accounting standard that requires recording the estimated value of stock-based compensation in the statement of operations.
Partially offsetting the above increases in our net loss were:
    lower expenses for the development of Prestara™, our investigational new drug for lupus and
 
    higher revenue as a result of the collaboration with Novartis.
     Revenue
     Contract revenue was $3.7 million in the first half of 2006 compared to $3.1 million in the first half of 2005. The $0.6 million increase in contract revenue was the result of revenue recognized under our recent collaboration with Novartis, for which there is no comparable revenue in 2005. In the first half of both 2006 and 2005, we recognized $2.8 million in revenue under the research collaboration and license

 


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agreement with Gilead. Also during the first half of both 2006 and 2005, we recognized $0.3 million in revenue from our two collaborations for Prestara for lupus.
     Royalty revenue was $0.3 million in the first six months of both 2006 and 2005.
     Research and Development Expenses
     The following table shows our research and development expenses by major category (in thousands):
                         
    For the six months ended June 30,    
    2006   2005   Change
     
Drug discovery (HCV)
  $ 3,814     $ 3,040       +25 %
Drug development (Prestara™)
    791       1,603       -51 %
Support costs and other research and development
    3,042       1,838       +66 %
             
Total research and development
  $ 7,647     $ 6,481       +18 %
             
     Research and development expenses increased by $1.2 million in the first half of 2006 compared to the first half of 2005. Expenses for drug discovery comprise the largest category of our research and development expenses. Drug discovery costs increased by $0.8 million in the first half of 2006 compared to the first half of 2005 primarily as a result of an increase in the number of scientists working on our HCV programs. We also entered into a new contract for optimizing the synthesis route and scale-up manufacturing for one of our HCV preclinical candidates and we conducted additional external preclinical studies of promising compounds. Development costs for Prestara were $0.8 million lower in the first half of 2006 than the first half of 2005 as a result of our completion of an open-label follow-on study in 2005 and a significantly lower number of employees working on the program in 2006. Support costs and other research and development costs were $1.2 million higher in the first half of 2006 than in the first half of 2005 due to higher costs recorded for our employee incentive bonus compensation program following our meeting key objectives in 2006 and the charge for stock-based compensation in 2006.
     General and Administrative Expenses
     General and administrative expenses were $4.3 million in the first half of 2006 compared to $2.9 million in the first half of 2005, an increase of $1.4 million. In the first half of 2006, our general and administrative expenses included a fee paid to a financial advisor related to the collaboration with Novartis. Other increases in the second quarter of 2006 compared to the second quarter of 2005 included higher legal expenses for patents and business development activities, including those related to the agreement with Novartis, higher charges for the employee incentive bonus program and charges for stock-based compensation.
     Liquidity and Capital Resources
     We assess liquidity primarily by the cash and cash equivalents available to fund our operations. Genelabs had cash and cash equivalents of $23.4 million at June 30, 2006.
     Genelabs presently estimates that our current cash resources would be adequate to provide liquidity for our existing operations through at least mid-2008. During the second quarter of 2006, we entered into two agreements which together increased our cash balance by more than $20 million. These two agreements were the collaboration with Novartis and the private placement financing. Prior to receiving the funds from these agreements there was substantial doubt about the ability of Genelabs to continue in business. Management believes that the additional funds secured by Genelabs sufficiently address this issue.

 


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     Longer-term, Genelabs believes its liquidity and capital resources will be materially impacted by our success or failure or the success or failure of our collaborators in reaching milestones under corporate collaborations, the progress of the Company’s unpartnered drug discovery programs, the ability to enter into or modify existing corporate collaborations, and regulatory actions regarding its investigational drugs.
     Since Genelabs’ inception, we have operated at a loss and have funded operations primarily through public and private offerings of equity securities and, to a lesser extent, contract revenues. We expect to incur substantial additional costs, including research costs for drug discovery. The amount of additional costs in our business plans will depend on numerous factors including the progress of our research and development programs and the actions of corporate collaborators. To meet our capital needs beyond the next two years we will require additional funding, but additional funds may not be available on acceptable terms, if at all. The unavailability of additional funds could delay or prevent the development, approval or marketing of some or all of our products and technologies, which would have a material adverse effect on our business, financial condition and results of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
     Genelabs’ exposure to market risk for changes in foreign currency exchange rates relates primarily to the Company’s investment in a Taiwan-based biopharmaceutical company, Genovate Biotechnology Co., Ltd., which is accounted for at cost, based on the lower of cost or market value method. This investment is the only item included in the balance sheet caption “Long-term investments.” Genelabs may attempt to divest a portion of this investment, in which case changes in foreign currency exchange rates would impact the proceeds received upon sale of these shares. Because the book value of Genelabs’ ownership percentage of Genovate is greater than our carrying cost, we currently do not believe that any foreign currency exchange rate changes would impact the value of this investment as reported in the financial statements unless the value of a Taiwan dollar depreciates by greater than 60% compared to the U.S. dollar, which, depending on other circumstances, might require Genelabs to record a non-cash charge to write-down the long-term investment.
Item 4. Controls and Procedures
     (a) Evaluation of Disclosure Controls and Procedures. The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) as of the end of the period covered by this report. Based on such evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act and are effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding disclosure.
     (b) Changes in Internal Control Over Financial Reporting. There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15 and 15d-15(f) under the Exchange Act) during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 


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PART II — OTHER INFORMATION
Item 1A. Risk Factors
     There are a number of risk factors that should be considered by Genelabs’ shareholders and prospective investors. It is not possible to comprehensively address all risks that exist, but the following risks in particular should be considered, in addition to other information in this Quarterly Report on Form 10-Q.
     Risks Related to Genelabs
     We have received a delisting notice from Nasdaq because we have not met the standards for continued listing on the Nasdaq quotation system, and if we are delisted the value of your investment in Genelabs may substantially decrease.
     To remain listed on the Nasdaq Capital Market we must have a market value of at least $35 million or at least $2.5 million in shareholders’ equity. To date in 2006, our market value has fluctuated between approximately $13 million and approximately $41 million. In our previous Quarterly Report on Form 10-Q, filed for the period ended March 31, 2006, our shareholders’ equity was a deficit of $0.8 million. Based on these factors, the Nasdaq Stock Market sent us a delisting notice, which we appealed to a listing qualifications panel. The listings qualification panel will make a decision about whether our stock remains listed on the Nasdaq Capital Market. Although we have provided the listings qualification panel with a forecast of our balance sheet as of June 30, 2006, showing that we expect our shareholders’ equity to be above $2.5 million, and this Quarterly Report on Form 10-Q shows shareholders’ equity above $2.5 million, we may still be delisted because we did not meet the continued listing standards at the time of receipt of the delisting notice. We may also be delisted because we may not have satisfied the panel that we will be able to sustain compliance with Nasdaq’s continued listing criteria. Even if the listing qualifications panel decides that we will not be delisted and that we can continue to be traded on the Nasdaq Capital Market, the panel may impose conditions upon our continued listing that we may be unable to meet. Delisting from the Nasdaq Capital Market would adversely affect the trading price of our common stock, significantly limit the liquidity of our common stock and impair our ability to raise additional funds.
     We may not be profitable in the near future or at all and in order to carry out our business plans we will require additional funds which may not be available.
     We have incurred losses each year since our inception and have accumulated approximately $236 million in net losses through June 30, 2006, including a net loss of $7.7 million for the six months ended June 30, 2006 and a net loss of $10.8 million for the year ended December 31, 2005. We may never be profitable and our revenues may never be sufficient to fund operations. We presently estimate that our current cash resources are adequate to fund our current operations for at least the next two years. Thereafter, we will require additional capital to carry out our business plans. We will require additional capital earlier if we decide to pursue FDA approval of Prestara without a collaborator.
     Additional funds for our research and development activities may not be available on acceptable terms, if at all. The unavailability of additional funds could delay or prevent the development of some or all of our products and technologies, which would have a material adverse effect on our business, financial condition and results of operations.
     The lease for our facilities expires in November and we may not have the facilities to continue our operations.

 


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     The lease for the facilities housing nearly all of our operations expires in November 2006. We may be unable to obtain an extension or renewal of the lease on acceptable terms, or at all. If we are unable to remain on our current premises, we may be unable to obtain alternative facilities and we may be unable to fully relocate our operations before termination of our current lease, thereby incurring a significant interruption in our business operations. Any relocation would result in substantial disruption of our operations and diversion of management and staff away from our core business activities. The terms for the existing or any new premises may require higher rent, advance payments, deposits or other terms disadvantageous to us.
     Our collaborations may fail.
     Given our financial position and the broad range of resources required for drug development, we have in the past and will likely continue to enter into collaborations with pharmaceutical and larger biotechnology companies. We have received no revenue from the sale of drugs. To date, almost all of our revenue has come from collaboration agreements. We have entered into collaborations with Novartis, Gilead, GlaxoSmithKline, Watson, Tanabe and other companies and we may enter into future collaborations with these or other companies. Our collaborators may breach their contracts, or our collaborators may not diligently and successfully develop and commercialize the results of the research. Alternatively, our collaborators may elect not to extend or augment the collaborations. In this regard, Novartis and/or Gilead may not continue to fund our research beyond their obligations in the research contracts, and GlaxoSmithKline may choose not to continue developing the hepatitis E vaccine which it has been developing under a license from us.
     We are dependent on our collaborators to successfully carry out preclinical and clinical development, to obtain regulatory approvals, and/or to market and sell any products arising from the research and/or development conducted by us or the collaborator. Factors which may cause our collaborators to fail in these efforts include: problems with toxicity, bioavailability or efficacy of the product candidate, difficulties in manufacture, problems in satisfying regulatory requirements, emergence of competitive product candidates developed by the collaborator or by others, insufficient commercial opportunity, problems the collaborators may have with their own contractors, lack of patent protection for our product candidates or claims by others that it infringes their patents or other intellectual property rights.
     Collaboration on a project also may result in disputes with the collaborator over the efforts by us and/or the collaborator, the achievement of milestones or rights to intellectual property. If we fail to perform all of our obligations, our collaborators may withhold further funding, seek to seize control over our intellectual property and other assets, and/or assert claims for damages against us. In the course of the collaboration our collaborator may obtain know-how which enables it to compete with us in the same area of research and/or development. Because research and development results are unpredictable, we and our collaborators may not achieve any of the milestones in the collaboration agreements. We may also find it difficult to advance to the development stage with some of our newer drug candidates if we are unable to find a suitable collaborator and we may not be able to negotiate new collaboration agreements on favorable terms or at all.
     Our research programs are in an early stage and may not successfully produce commercial products.
     Pharmaceutical discovery research is inherently high-risk because of the high failure rate of projects. To date, our pharmaceutical research has been focused on a limited number of targets for which no or few commercial drugs have been successfully developed. Our projects may fail if, among other reasons, the compounds being developed fail to meet criteria for potency, toxicity, pharmacokinetics, manufacturability, intellectual property protection and freedom from infringement, or other criteria; or if we fail to make progress due to lack of resources or access to enabling technologies. Genelabs’ product candidates, other

 


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than Prestara™, are in an early stage of research. All of our research projects may fail to produce commercial products.
          We face substantial competition which may result in others discovering, developing or commercializing drugs before or more successfully than us.
     The biotechnology industry is highly competitive and characterized by rapid and significant technological change. Creation of the type of compounds we seek to discover requires sophisticated and expensive lab equipment and facilities, a team of scientists with advanced scientific knowledge in many disciplines such as chemistry, biochemistry and biology, and time and effort. We face, and will continue to face, intense competition from organizations such as pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies. Many of these organizations are also pursuing the discovery and development of new drugs to treat infection with the hepatitis C virus, and some are at a more advanced stage of development. Any of these organizations may discover, develop or commercialize products that are more effective, safer or less costly than those that we are developing. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours.
     Many of our competitors are substantially larger than we are and have greater capital resources, larger research and development staffs and better facilities than we have. Many of our competitors are more experienced in drug discovery, development and commercialization, in obtaining regulatory approvals and in drug manufacturing and marketing. In addition, if Genelabs discovers compounds that have the potential to be drugs, public information about our research success may lead other companies with greater resources to focus more efforts in areas similar to ours. Because large pharmaceutical companies have access to the latest equipment and have many more personnel available to focus on solving particular research problems, even if our research programs are successful we may have a competitive disadvantage.
     If third parties on whom we rely do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our product candidates.
     As part of our process of conducting drug discovery research and clinical trials we rely on third parties such as medical institutions, pre-clinical and clinical investigators, contract laboratories and contract research organizations to participate in the conduct of our clinical trials. We also rely on contract manufacturers for supply of active ingredients and formulated material for use in preclinical and clinical development. We depend on Novartis, Gilead and GlaxoSmithKline to conduct preclinical and clinical development, to obtain regulatory approval and to manufacture and commercialize our product candidates. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our preclinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
     The results of our clinical trial of Prestara™, Genelabs’ drug candidate for systemic lupus erythematosus, were not positive, substantially decreasing the probability that Prestara will ever be approved for marketing and thus diminishing our business prospects.
     In order to satisfy conditions set by the U.S. Food and Drug Administration, or FDA, we conducted a Phase III clinical trial of Prestara™ on women with lupus taking glucocorticoids using bone mineral density as the trial’s primary endpoint. Prestara™ is a pharmaceutical formulation containing highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone or DHEA, a naturally occurring hormone. This clinical trial did not demonstrate a statistically significant difference between the bone mineral density of the group of patients taking Prestara™ and the group taking placebo. Additionally, the trial was not

 


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powered to demonstrate, and in fact did not demonstrate, a statistically significant benefit in secondary endpoints such as amelioration of lupus symptoms.
     Because our clinical trial did not meet its primary endpoint, the FDA will not approve Prestara™ without another Phase III clinical trial. It may not be possible to design and implement a trial that would successfully provide results sufficient to obtain FDA approval for Prestara™, and Genelabs currently does not have the funds to conduct such a trial.
     Our outside suppliers and manufacturers for Prestara™ are subject to regulation, including by the FDA, and if they do not meet their commitments, we would have to find substitute suppliers or manufacturers which could delay supply of product to the market.
     Regulatory requirements applicable to pharmaceutical products tend to make the substitution of suppliers and manufacturers costly and time consuming. We rely on a single supplier of prasterone, the active ingredient in Prestara™, and we rely on a single finished product manufacturer, Patheon Inc., for production of Prestara™ capsules and for packaging. The disqualification of a supplier or manufacturer through their failure to comply with regulatory requirements could negatively impact our business because of delays and costs in obtaining and qualifying alternate suppliers. We have no internal manufacturing capabilities for pharmaceutical products and are entirely dependent on contract manufacturers and suppliers for the manufacture of our drug candidates. Genelabs and our North American collaborator, Watson, previously arranged for the manufacture of quantities of Prestara™ and its active ingredient in anticipation of possible marketing approval. This inventory has exceeded its initial expiration date, although the expiration date of the active ingredient may be extended if it successfully passes re-testing.
     The following could harm our ability to manufacture Prestara™:
    the unavailability at reasonable prices of adequate quantities of the active ingredient or intermediates;
 
    the loss of a supplier’s or manufacturer’s regulatory approval;
 
    the failure of a supplier or manufacturer to meet regulatory agency pre-approval inspection requirements;
 
    the failure of a supplier or manufacturer to maintain compliance with ongoing regulatory agency requirements;
 
    the inability to develop alternative sources in a timely manner or at all;
 
    inability or refusal of the manufacturers to meet our needs for any reason, such as loss or damage to facilities or labor disputes;
 
    manufacture of product that is defective in any manner; and
 
    competing demands on the contract manufacturer’s capacity, for example, shifting manufacturing priorities to their own products or more profitable products for other customers.
     We may be unable to obtain patents or protect our intellectual property rights, or others could assert their patents against us.
     Agency or court proceedings could invalidate our current patents, or patents that issue on pending applications. Our business would suffer if we do not successfully defend or enforce our patents, which

 


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would result in loss of proprietary protection for our technologies and products. Patent litigation may be necessary to enforce patents to determine the scope and validity of our proprietary rights or the proprietary rights of another.
     The active ingredient in Prestara™ is prasterone, more commonly known as dehydroepiandrosterone, or DHEA. DHEA is a compound that has been in the public domain for many years. Although we have an issued U.S. patent on the specific polymorphic form of DHEA we have used in our formulation of prasterone, we do not believe it is possible to obtain patent protection for the base chemical compound anywhere in the world. Genelabs licensed two United States patents covering uses of DHEA in treating lupus from Stanford University in 1993. The Stanford patents expire in 2012 and 2013, and the license expires when the patents expire. In addition, we have filed patent applications covering additional uses for Prestara™ and various pharmaceutical formulations and intend to file additional applications as appropriate. We have filed patent applications covering compounds from our HCV drug discovery programs; however, none of these HCV applications have issued. A number of patents have issued to Genelabs covering our drug discovery technologies and methods related to selective regulation of gene expression and the control of viral infections. A number of patent applications are pending.
     If another company successfully brings legal action against us claiming our activities violate, or infringe, their patents, a court may require us to pay significant damages and prevent us from using or selling products or technologies covered by those patents. Others could independently develop the same or similar discoveries and may have priority over any patent applications Genelabs has filed on these discoveries. Prosecuting patent priority proceedings and defending litigation claims can be very expensive and time-consuming for management. In addition, intellectual property that is important for advancing our drug discovery efforts or for uses for the active ingredient in Prestara™ owned by others might exist now or in the future. We might not be able to obtain licenses to a necessary product or technology on commercially reasonable terms, or at all, and therefore, we may not pursue research, development or commercialization of promising products.
     We may be unable to attract or retain key personnel.
     Our ability to develop our business depends in part upon our attracting and retaining qualified management and scientific personnel. We do not have employment agreements with any of our employees.
     We have recently entered into a collaboration with Novartis which will require us to dedicate a specified level of scientific personnel to the work plan established with Novartis. We have similar obligations under our collaboration with Gilead. Because we have obligations to dedicate a specified number of scientists to the collaborations, we may not have sufficient personnel to continue to advance our unpartnered NS5a drug discovery program. As the number of qualified personnel is limited, competition for such staff is intense. We may not be able to continue to attract or retain such people on acceptable terms, given the competition for those with similar qualifications among biotechnology, pharmaceutical and healthcare companies, universities and nonprofit research institutions.
     Our collaborations with Novartis and Gilead specify the funding rates for Genelabs’ scientific personnel working on the collaborations, which means we bear the risk of any personnel cost increases. The loss of our key personnel, significant salary increases to retain our key personnel or the failure to recruit additional key personnel could significantly impede attainment of our objectives and harm our financial condition and operating results. Additionally, recent and proposed laws, rules and regulations increasing the liability of directors and officers may make it more difficult to retain incumbents and to recruit for these positions.
     Our facilities are located near an earthquake fault, and an earthquake could disrupt our operations and adversely effect results.

 


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     All of our operations are conducted in a single facility built on landfill in an area of California near active geologic faults which historically have caused major earthquakes from time to time. The office park where the facility is located is approximately at sea level behind levees sheltering the buildings from the San Francisco Bay. In the event of a significant earthquake, we could experience significant damage and business interruption. We currently have insurance coverage for earthquake and flood damage, including business interruption coverage due to those events, with limits of $5 million and subject to a deductible which currently is approximately $1.6 million. There is no assurance that earthquake or flood insurance will continue to be available at a cost that is acceptable to us or that such insurance will be adequate to reimburse our losses.
     Industry Risks
     Our activities involve hazardous materials and improper handling of these materials by our employees or agents could expose us to significant legal and financial penalties.
     Our research and development activities involve the controlled use of hazardous materials, including infectious agents, chemicals and various radioactive compounds. Our organic chemists use solvents, such as chloroform, isopropyl alcohol and ethanol, corrosives such as hydrochloric acid and highly flammable materials, some of which are pressurized, such as hydrogen. We use radioactive compounds in small quantities under license from the State of California, including Carbon(14), Cesium(137), Chromium(51), Hydrogen(3), Iodine(125), Phosphorus(32), Phosphorus(33) and Sulfur(35). Our biologists use biohazardous materials, such as bacteria, fungi, parasites, viruses and blood and tissue products. We also handle chemical, medical and radioactive waste, byproducts of our research, through licensed contractors. As a consequence, we are subject to numerous environmental and safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Federal, state and local governments may adopt additional laws and regulations affecting us in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, current or future laws or regulations.
     Although we believe that our safety procedures for using, handling, storing and disposing of hazardous materials comply with the standards prescribed by state and federal regulations, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of an accident, state or federal authorities may curtail our use of these materials and we could be liable for any civil damages that result, the cost of which could be substantial. Further, any failure by us to control the use, disposal, removal or storage of, or to adequately restrict the discharge of, or assist in the cleanup of, hazardous chemicals or hazardous, infectious or toxic substances could subject us to significant liabilities, including joint and several liability under state or federal statutes. We do not specifically insure against environmental liabilities or risks regarding our handling of hazardous materials. Additionally, an accident could damage, or force us to shut down, our research facilities and operations.
     We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities in order to protect ourselves against product liability claims.
     Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic products. We may become subject to product liability claims if someone alleges that the use of our products injured subjects or patients. This risk exists for products tested in human clinical trials as well as products that are sold commercially. Although we currently have insurance coverage in amounts that we believe are customary for companies of our size and in our industry and sufficient for risks we typically face, including general liability insurance of $6 million, we may not be able to maintain this type of insurance in a sufficient amount. We currently maintain $5 million of product liability insurance for claims arising from the use of our products in clinical trials. In addition,

 


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product liability insurance is becoming increasingly expensive. As a result, we may not be able to obtain or maintain product liability insurance in the future on acceptable terms or with adequate coverage against potential liabilities which could harm our business by requiring us to use our resources to pay potential claims.
     Risks Relating to Owning Our Stock
     Because our stock is volatile, the value of your investment in Genelabs may substantially decrease.
     The market price of our common stock, like the stock prices of many publicly traded biopharmaceutical companies, has been and will probably continue to be highly volatile. Between January 1, 2005 and December 31, 2005, the price of our common stock fluctuated between $6.15 and $1.70 per share, as adjusted for the reverse-split. Between January 1, 2006 and July 28, 2006, the price of our common stock fluctuated between $2.55 and $0.70 per share. In addition to the factors discussed in this Risk Factors section, a variety of events can impact the stock price, including the low percentage of institutional ownership of our stock, which contributes to lack of stability for the stock price. The availability of a large block of stock for sale in relation to our normal trading volume could also result in a decline in the market price of our common stock.
   In addition, numerous events occurring outside of our control may also impact the price of our common stock, including:
    progress of our products through the regulatory process;
 
    results of preclinical studies and clinical trials;
 
    announcements of technological innovations or new products by us or our competitors;
 
    government regulatory actions affecting our products or our competitors’ products in the United States or foreign countries;
 
    developments or disputes concerning patent or proprietary rights;
 
    actual or anticipated fluctuations in our operating results;
 
    changes in our financial estimates by securities analysts;
 
    general market conditions for emerging growth, biotechnology and pharmaceutical companies;
 
    broad market fluctuations; and
 
    economic conditions in the United States or abroad.
          Changes in securities laws and regulations may increase our costs.
     The Sarbanes-Oxley Act of 2002 has previously required us to make changes to some of our corporate governance practices. Because we are currently a non-accelerated filer we presently do not have to comply with Section 404 of the Sarbanes-Oxley Act, which requires annual management assessments of the effectiveness of our internal controls over financial reporting and also a report by our independent registered public accounting firm addressing these assessments. However, beginning with calendar year 2007 we may again be required to comply with this rule, which will substantially increase our general and administrative expenses. We also may determine that we do not have effective controls over financial reporting. There may be other accounting or regulatory changes enacted in the future which would have a disproportionate impact on us compared to other companies because of our small size and our lack of product revenue to provide a source of funds to pay for compliance with the changes, among other reasons.
Item 4. Submission of Matters to a Vote of Security Holders

 


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     On June 16, 2006, we held our annual meeting of shareholders. Shareholders voted on two proposals at the meeting and the voting results were as follows:
1.   Election of our Directors:
                 
    Affirmative   Withheld
    Votes   Votes
Irene A. Chow
    14,086,140       688,063  
Arthur Gray, Jr.
    14,062,833       711,370  
H. H. Haight
    14,063,649       710,554  
Alan Y. Kwan
    14,068,913       705,290  
James A. D. Smith
    14,063,721       710,482  
2.   A proposal to ratify the selection of Ernst & Young LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2006 was approved with 14,157,247 affirmative votes, 560,404 negative votes, and 56,552 abstentions.
Item 6. Exhibits
     
Exhibit    
Number   Description
 
3.01
  Registrant’s Amended and Restated Articles of Incorporation (incorporated herein by reference to Exhibit 3.01 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2001).
 
   
3.02
  Registrant’s Certificate of Amendment of Articles of Incorporation (incorporated herein by reference to Exhibit 3.2 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003).
 
   
3.03
  Registrant’s Certificate of Amendment of Articles of Incorporation dated December 14, 2005 (incorporated herein by reference to Exhibit 3.03 to Registrant’s Annual Report on Form 10-K for the year ended December 31, 2005 (the “2005 Form 10-K”)).
 
   
3.04
  Registrant’s Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.02 to Registrant’s Annual Report on Form 10-K for the year ended December 31, 2000).
 
   
4.01
  Specimen Certificate for Registrant’s Common Stock (incorporated herein by reference to Exhibit 4.01 to Registrant’s 2005 Form 10-K).
 
   
 10.22
  License and Research Collaboration Agreement between the Registrant and Novartis Institutes for BioMedical Research, Inc. dated as of June 2, 2006.**
 
   
31.1
  Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
 
   
31.2
  Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
 
   
32.1
  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
**   Confidential treatment has been requested with respect to certain portions of this document.

 


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SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
 
  GENELABS TECHNOLOGIES, INC.    
 
  (Registrant)    
 
       
 
  Principal Executive Officer:    
 
       
 
  /s/ James A.D. Smith    
Date: August 3, 2006
       
 
       
 
  James A.D. Smith    
 
  President and Chief Executive Officer    
 
       
 
  Principal Financial and Chief Accounting Officer:    
 
       
 
  /s/ Matthew M. Loar    
Date: August 3, 2006
       
 
       
 
  Matthew M. Loar    
 
  Chief Financial Officer    

 


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EXHIBIT INDEX
     
Exhibit    
Number   Description
 
3.01
  Registrant’s Amended and Restated Articles of Incorporation (incorporated herein by reference to Exhibit 3.01 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2001).
 
   
3.02
  Registrant’s Certificate of Amendment of Articles of Incorporation (incorporated herein by reference to Exhibit 3.2 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003).
 
   
3.03
  Registrant’s Certificate of Amendment of Articles of Incorporation dated December 14, 2005 (incorporated herein by reference to Exhibit 3.03 to Registrant’s Annual Report on Form 10-K for the year ended December 31, 2005 (the “2005 Form 10-K”)).
 
   
3.04
  Registrant’s Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.02 to Registrant’s Annual Report on Form 10-K for the year ended December 31, 2000).
 
   
4.01
  Specimen Certificate for Registrant’s Common Stock (incorporated herein by reference to Exhibit 4.01 to Registrant’s 2005 Form 10-K).
 
   
 10.22
  License and Research Collaboration Agreement between the Registrant and Novartis Institutes for BioMedical Research, Inc. dated as of June 2, 2006.**
 
   
31.1
  Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
 
   
31.2
  Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
 
   
32.1
  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
**   Confidential treatment has been requested with respect to certain portions of this document.

 

EX-10.22 2 f22362exv10w22.htm EXHIBIT 10.22 exv10w22
 

Exhibit 10.22
[ * *] = 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.
LICENSE AND RESEARCH COLLABORATION AGREEMENT
between
GENELABS TECHNOLOGIES, INC.
and
NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.

 


 

TABLE OF CONTENTS
         
    (a) Page  
1. DEFINITIONS AND INTERPRETATION
    1  
1.1 Definitions
    1  
1.2 Interpretation
    11  
 
       
2. RESEARCH PROGRAM
    12  
2.1 General
    12  
2.2 Conduct of Research
    12  
2.3 Expansion of Collaboration Field
    13  
2.4 Genelabs’ FTEs
    14  
2.5 Joint Research Committee
    15  
2.6 Exchange of Information
    17  
2.7 Records and Reports
    17  
2.8 Research Program Term; Termination
    19  
2.9 Compliance
    20  
2.10 Liability
    20  
2.11 Materials
    20  
2.12 Scope of this Agreement
    21  
 
       
3. LICENSE; DEVELOPMENT AND COMMERCIALIZATION; EXCLUSIVITY
    21  
3.1 License Grant
    21  
3.2 Negative Covenants; No Implied Licenses
    22  
3.3 Development and Commercialization; Diligence
    22  
3.4 Excused Performance
    22  
3.5 Reports on PHARMA Efforts
    23  
3.6 NS5a Program Rights
    23  
3.7 Exclusivity
    25  
 
       
4. CONFIDENTIALITY AND PUBLICATION
    25  
4.1 Nondisclosure Obligation
    25  
4.2 Permitted Disclosures
    26  
4.3 Publications
    27  
4.4 Publicity
    27  
 
       
5. PAYMENTS; ROYALTIES AND REPORTS
    28  
5.1 Upfront Fee
    28  
5.2 FTE Rate and Funding
    28  
5.3 Milestone Payments
    28  
5.4 Payment of Milestone Payments
    29  
5.5 Royalties
    29  
5.6 Reports; Payment of Royalty
    30  
5.7 Audits
    31  
5.8 Payments and Exchange Rate
    31  
5.9 Income Tax Withholding
    32  

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    (a) Page  
5.10 No Projections
    32  
 
       
6. REPRESENTATIONS, WARRANTIES AND COVENANTS
    32  
6.1 Representations and Warranties of Both Parties
    32  
6.2 Genelabs Representations and Warranties
    33  
6.3 Genelabs Covenants
    34  
6.4 Disclaimer
    34  
 
       
7. INTELLECTUAL PROPERTY RIGHTS
    34  
7.1 Ownership of Joint Inventions
    34  
7.2 Patent Prosecution
    35  
7.3 Patent Infringement
    37  
7.4 Defense of Actions
    38  
7.5 Recoveries
    38  
7.6 Drug Price Competition and Patent Term Restoration Act
    38  
 
       
8. LIMITATION OF LIABILITY
    39  
 
       
9. TERM AND TERMINATION
    39  
9.1 Term and Expiration
    39  
9.2 Termination by PHARMA
    39  
9.3 Termination for Cause
    39  
9.4 Effect of Expiration or Termination; Survival
    41  
9.5 Rights in Bankruptcy
    41  
 
       
10. INDEMNIFICATION
    42  
10.1 Indemnification by PHARMA
    42  
10.2 Indemnification by Genelabs
    42  
10.3 Control of Defense
    43  
10.4 Insurance
    44  
 
       
11. MISCELLANEOUS
    44  
11.1 Force Majeure
    44  
11.2 Assignment and Change of Control
    45  
11.3 Severability
    45  
11.4 Notices
    45  
11.5 Applicable Law
    46  
11.6 Jurisdiction
    46  
11.7 Entire Agreement; Amendments
    46  
11.8 Headings
    47  
11.9 Independent Contractors
    47  
11.10 Waiver
    47  
11.11 Cumulative Remedies
    47  
11.12 Waiver of Rule of Construction
    48  
11.13 Trademark Rights
    48  
11.14 Compliance with Law
    48  
11.15 Counterparts
    48  
11.16 No Third Party Beneficiaries
    48  
11.17 Extension to Affiliates
    48  
11.18 Further Assurances
    48  

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[ * *] = 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.
LICENSE AND RESEARCH COLLABORATION AGREEMENT
          This Agreement (the “Agreement”) dated as of June 2, 2006 (the “Effective Date”) is made between Genelabs Technologies, Inc., a California corporation having its principal place of business at 505 Penobscot Drive, Redwood City, California 94063 (“Genelabs”), and Novartis Institutes for BioMedical Research, Inc., a Delaware corporation having its principal place of business at 250 Massachusetts Avenue, Cambridge, Massachusetts 02142 (“PHARMA”).
RECITALS:
          WHEREAS, Genelabs has a research program for the discovery and optimization of certain Non-nucleoside inhibitors of the NS5b polymerase of the hepatitis C virus;
          WHEREAS, PHARMA and Genelabs desire to enter into a research collaboration to discover Collaboration Compounds (as hereinafter defined) upon the terms and conditions set forth herein; and
          WHEREAS, PHARMA desires to develop and commercialize Products in the Field (in each case, as hereinafter defined) arising from the collaboration and Genelabs desires to grant such rights, in each case upon the terms and conditions set forth herein.
          NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
1.   DEFINITIONS AND INTERPRETATION
          1.1 Definitions. Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below. References to “Articles”, “Sections” and “subsections” in this Agreement shall be to Articles, Sections and subsections respectively, of this Agreement unless otherwise specifically provided.
Accounting Standards” shall mean, with respect to Genelabs, US GAAP (United States Generally Accepted Accounting Principles) and, with respect to PHARMA, IFRS (International Financial Reporting Standards), in each case, as generally and consistently applied throughout such Party’s organization.
Affiliate” shall mean, with respect to any Person, any other Person who directly or indirectly controls or is controlled by or is under common control with such Person. For purposes of this definition, “control” or “controlled” means ownership directly or through one or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interest in the case of any other type of legal entity, status as a

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[ * *] = 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.
general partner in any partnership, or any other arrangement whereby a Person controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.
The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.
Agreed Limit” shall have the meaning set forth in Section 5.5(d).
Bankruptcy” shall mean, with respect to a Party, such Party becomes insolvent, makes or has made an assignment for the benefit of creditors, is the subject of proceedings in voluntary or involuntary bankruptcy instituted on behalf of or against such Party (except for involuntary bankruptcy proceedings which are dismissed within sixty (60) days), or has a receiver or trustee appointed for substantially all of its property.
Business Day” means any day other than Saturday or Sunday on which the banks in New York are open for business.
Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31.
Change of Control” shall mean, with respect to a Party, the occurrence of any of the following: (a) any consolidation or merger of such Party with or into any other entity, or any other corporate reorganization involving another entity, in which those Persons that are stockholders of such Party immediately prior to such consolidation, merger or reorganization own less than fifty percent (50%) of the surviving entity’s voting power immediately after such consolidation, merger or reorganization; (b) any Person (or group of Persons acting in concert) becomes the beneficial owner (as defined in Rule 13d-3 under the Securities Exchange Act of 1934, as amended, except that a Person shall be deemed to have “beneficial ownership” of all shares that any such Person has the right to acquire, whether such right is exercisable immediately or only after the passage of time), directly or indirectly, of more than fifty percent (50%) of the total voting power of the equity securities then outstanding of such Party normally entitled to vote in elections of directors; or (c) the sale, transfer, lease, license or other disposition to any Person of all or substantially all of such Party’s assets in one or a series of related transactions.

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[ * *] = 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.
Collaboration Compound” shall mean a Genelabs Compound or PHARMA Compound.
Collaboration Field” shall mean Non-nucleoside inhibitors [**] of the HCV NS5b RNA polymerase, as such field may be expanded by PHARMA from time to time pursuant to Section 2.3.
Collaboration Know-How” shall mean the Genelabs Know-How and the PHARMA Know-How.
Collaboration Patents” shall mean the Genelabs Patents and the PHARMA Patents.
Collaboration Technology” shall mean the Collaboration Know-How and Collaboration Patents.
commercialize” or “commercialization” shall mean activities directed to marketing, promoting, distributing, importing, exporting, offering for sale and/or selling a Product.
Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party to achieve a stated objective, the good faith, diligent efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that, with respect to efforts to be expended with respect to development or commercialization of a Collaboration Compound or Product hereunder, such efforts shall be substantially consistent with [**]. It is anticipated that the level of effort may change from time to time.
Committee” shall mean the joint research committee established to oversee the Research Program as more fully described in Section 2.5.
Competitor” shall mean any Person other than PHARMA or its Affiliates which is engaged directly or indirectly through its Affiliates, in the research, development or commercialization of pharmaceutical products. “Competitor” shall exclude purely financial investors not under the direct or indirect control of (“control” having the meaning set forth in the definition of “Affiliates”) any entity that is engaged, directly or indirectly through its other Affiliates, in the research, development or commercialization of pharmaceutical products.
Confidential Information” shall have the meaning given such term in Section 4.1.
Confidentiality Agreements” means, collectively (i) that certain Confidentiality Agreement between the Parties dated [**], (ii) the Letter Agreement and (iii) that certain Material Transfer Agreement between the Parties dated [**].

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[ * *] = 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.
Control” or “Controlled” shall mean, with respect to any Know-How, Patents, Information or other intellectual property rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Know-How, Patents, Information or other intellectual property rights to another Person, or to otherwise disclose such proprietary or trade secret information to another Person, without (i) breaching the terms of any agreement with a Third Party, (ii) misappropriating the proprietary or trade secret information of a Third Party or (iii) solely with respect to any Know-How, Patents, Information, other intellectual property rights or proprietary or trade secret information relating solely to research tools, incurring an obligation for payment to a Third Party.
develop” or “development” shall mean clinical drug development activities, including, without limitation, test method development and stability testing, assay development and audit development, toxicology, formulation, quality assurance/quality control development, statistical analysis, clinical studies, packaging development, regulatory affairs, and the preparation, filing and prosecution of NDAs.
EMEA” shall mean the European Medicines Agency and any successor agency thereto.
Encumbrance” shall mean any claim, charge, equitable interest, hypothecation, lien, mortgage, pledge, option, license, assignment, power of sale, retention of title, right of pre-emption, right of first refusal or security interest of any kind.
Excluded Affiliate” with respect to a Party, shall mean an entity which is not an Affiliate of such Party on the Effective Date but which first satisfies the requirements for being an Affiliate of such Party after the Effective Date.
Exclusivity Period” shall mean (i) with respect to Genelabs and its Affiliates, a period consisting of the Research Program Term [**] and (ii) with respect to PHARMA and its Affiliates, a period consisting of the Research Program Term.
FDA” shall mean the United States Food and Drug Administration, or a successor federal agency thereto.
Field” shall mean all fields of use including, but not limited to, diagnostics, therapeutics and prophylaxis in human and animal health care.
First Commercial Sale” shall mean, with respect to any Product, the first arm’s length sale to a Third Party for end use or consumption of such Product in a country after all required Regulatory Approvals with respect to such Product have been granted by the applicable Regulatory Authority of such country.
FTE” or “Full Time Equivalent” shall mean the equivalent of a full-time qualified Genelabs employee’s work time (consisting of [**]) for scientific work on or directly

4


 

[ * *] = 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.
related to the Research Program. For purposes of the definition of “FTE”, such work time includes, [**].
FTE Rate” shall have the meaning set forth in Section 5.2(a).
Genelabs Background Know-How” shall mean Know-How owned or Controlled by Genelabs or its Affiliates as of the Effective Date or at any time during the period consisting of the Research Program Term which is necessary or useful for the conduct of the Research Program or the research or development of Collaboration Compounds or Products and which is not Genelabs Know-How.
Genelabs Background Patents” shall mean Patents owned or Controlled by Genelabs or its Affiliates as of the Effective Date or at any time during the term of this Agreement (i) that claim Know-How existing as of the Effective Date or at any time during the period consisting of the Research Program Term which is necessary or useful for the conduct of the Research Program or the research or development of Collaboration Compounds or Products, (ii) which are not Genelabs Patents, and (iii) which, but for the license granted in Section 3.1(a), would be infringed by the conduct of the research or development of Collaboration Compounds or Products.
Genelabs Background Technology” shall mean the Genelabs Background Know-How and Genelabs Background Patents.
Genelabs Compound” shall mean any Non-nucleoside compound in or outside of the Collaboration Field which (i) is listed on Exhibit 1.A or (ii) is or was identified, discovered or synthesized by or for Genelabs or its Affiliates under the Research Program and, in each case, Related Compounds of such compound.
Genelabs Know-How” shall mean any Know-How owned or Controlled (including through a license with the right to sublicense to PHARMA hereunder) by Genelabs or its Affiliates as of the Effective Date or at any time during the Research Program Term relating to any Collaboration Compounds and/or Products [**].
Genelabs Patents” shall mean the Patents identified in Exhibit 1.B and any other Patents owned or Controlled (including through a license with the right to sublicense to PHARMA hereunder) by Genelabs or its Affiliates as of the Effective Date or at any time during the term of this Agreement, that claim Know-How existing as of the Effective Date or at any time during the Research Program Term, having claims covering any Collaboration Compounds and/or Products, [**]. For clarification, Genelabs Patents includes Genelabs’ interest in Joint Patents.
Genelabs Technology” shall mean the Genelabs Know-How and Genelabs Patents.

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[ * *] = 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.
Good Laboratory Practices” or “GLP” shall mean Good Laboratory Practices regulations and guidelines as promulgated by the FDA, as such regulations may be amended from time to time, and any comparable foreign standards as applicable.
HCV” shall mean hepatitis C virus, including all subtypes thereof.
IND” shall mean an Investigational New Drug application filed with the FDA or the corresponding application for the investigation of Products in any other country or group of countries, as defined in the applicable laws and regulations and filed with the Regulatory Authority of such country or group of countries.
Information” shall mean any and all information, data, results, inventions, trade secrets, techniques, material, or compositions of matter of any type or kind, including without limitation all Know-How and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated in writing or orally or by any other method, which is disclosed by one Party or its Affiliates to the other Party or its Affiliates in connection with this Agreement.
Initial Research Program Term” shall have the meaning set forth in Section 2.8.1.
Invention” shall mean any process, method, use, composition of matter, article of manufacture, discovery, finding or other invention, whether or not patentable.
Joint Invention” shall mean any Invention that is discovered, made or conceived in the course of the Research Program during the Research Program Term jointly by employees of Genelabs and PHARMA or their Affiliates or others working on behalf of Genelabs and PHARMA, respectively, or their Affiliates, including Patents and other intellectual property rights covering such Joint Inventions.
Joint Patents” shall mean Patents claiming any Joint Invention.
Joint Technology” shall mean Joint Inventions and Joint Patents.
Know-How” shall mean all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and other data and information, including records of activities under the Research Program contemplated by Section 2.7.1, and (b) compounds, compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
Letter Agreement” shall mean that certain letter agreement between Genelabs and Novartis Pharma AG dated [**].

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[ * *] = 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.
Major European Country” shall mean [**].
Major Market” shall mean the United States and the Major European Countries.
Materials” shall have the meaning set forth in Section 2.11(a).
Milestone Payments” shall have the meaning set forth in Section 5.3.
NDA” shall mean an application submitted to a Regulatory Authority for marketing approval of a product, including (a) a New Drug Application, Product License Application or Biologics License Application filed with the FDA or any successor applications or procedures, or any foreign equivalent thereof, and (b) all supplements and amendments that may be filed with respect to the foregoing.
Net Sales” with respect to any Product shall mean the net sales on behalf of PHARMA and any PHARMA Affiliate, licensee or sublicensee for that Product sold to Third Parties other than licensees or sublicensees in bona fide, arms-length transactions, as determined in accordance with PHARMA’s Accounting Standards. Sales from PHARMA to its Affiliates shall be disregarded for purposes of calculating Net Sales.
(a) In the case of any sale or other disposal of a Product between or among PHARMA and its Affiliates, licensees or sublicensees, for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s-length sale thereafter to a Third Party which is not a licensee or sublicensee;
(b) In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Product is paid for, if paid for before shipment or invoice;
c) In the case of any sale or other disposal for value, such as barter or counter-trade, of any Product, or part thereof, other than in an arm’s length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Product in the country of sale or disposal;
d) In the event the Product is sold in a finished dosage form containing the Collaboration Compound in combination with one or more other active ingredients (a “Combination Product”), the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as defined above) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. In the event that such average sale price cannot be determined for both the Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be agreed by the Parties based

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[ * *] = 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.
on the relative value contributed by each component, such agreement shall not be unreasonably withheld.
Non-nucleoside” shall mean any compound other than a compound (together with its Related Compounds) [**].
NS5a Assets” shall mean compounds and related intellectual property owned or Controlled by Genelabs or its Affiliates arising from or related to the NS5a Program.
NS5a Program” shall mean Genelabs’ proprietary research program to discover and optimize small molecule compounds that inhibit HCV replication by directly or indirectly affecting the HCV NS5a protein.
Party” shall mean PHARMA or Genelabs.
Patents” shall mean (a) all patents, certificates of invention, applications for certificates of invention, and patent applications, including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention, throughout the world, together with (b) any renewal, divisional, continuation (in whole or in part), or continued prosecution applications of any of such patents, certificates of invention and patent applications, and any and all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, supplemental protection certificates, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any foreign counterparts of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.
Person” shall mean any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
PHARMA Background Know-How” shall mean Know-How owned or Controlled by PHARMA or its Affiliates as of the Effective Date or at any time during the Research Program Term which is necessary or useful for the conduct of the Research Program and which is not PHARMA Know-How.
PHARMA Background Patents” shall mean Patents owned or Controlled by PHARMA or its Affiliates as of the Effective Date or at any time during the term of this Agreement (i) that claim Know-How existing as of the Effective Date or at any time during the Research Program Term which is necessary or useful for the conduct of the Research Program, (ii) which are not PHARMA Patents, and (iii) which, but for the license granted in Section 3.1(b), would be infringed by the conduct of the Research Program.
PHARMA Background Technology” shall mean the PHARMA Background Know-How and PHARMA Background Patents.

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[ * *] = 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.
PHARMA Compound” shall mean any compound in the Collaboration Field which is identified, discovered or synthesized by or for PHARMA or its Affiliates during the Research Program Term and Related Compounds of any such compound. Notwithstanding the foregoing, “PHARMA Compound” shall not include any compound in the Collaboration Field which is being researched, developed, commercialized, distributed, marketed or sold (alone or in collaboration with a Third Party) by an Excluded Affiliate of PHARMA prior to the time such Excluded Affiliate becomes an Affiliate of PHARMA.
PHARMA Know-How” shall mean any Know-How owned or Controlled (including through a license with the right to sublicense to Genelabs hereunder) by PHARMA or its Affiliates as of the Effective Date or at any time during the Research Program Term relating to any Collaboration Compounds and/or Products [**].
PHARMA Patents” shall mean any Patents owned or Controlled (including through a license with the right to sublicense to Genelabs hereunder) by PHARMA or its Affiliates as of the Effective Date or at any time during the Research Program Term having claims covering the Collaboration Compounds and/or Products, [**]. For clarification, PHARMA Patents includes PHARMA’s interest in Joint Patents.
PHARMA Technology” shall mean the PHARMA Know-How and PHARMA Patents.
Phase I Clinical Trial” shall mean a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics (as more fully defined in Federal Regulation 21 C.F.R. § 312.21(a) and its foreign equivalents).
Phase II Clinical Trial” shall mean a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence Phase III clinical trials or to file for accelerated approval (as further defined in Federal Regulation 21 C.F.R. § 312.21(b) and its foreign equivalents).
Phase III Clinical Trial” or “Pivotal Clinical Trial” shall mean a controlled study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA to obtain Regulatory Authority to market the product, as further defined in Federal Regulation 21 C.F.R. § 312.21(c), and its foreign equivalents.
Preclinical Development” shall mean testing of a Collaboration Compound in GLP in vivo toxicology studies.
Product(s)” shall mean a product incorporating or comprising as an active ingredient one or more Collaboration Compounds in finished dosage pharmaceutical form. For

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[ * *] = 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.
purposes of Section 5.5, Product shall also include any other form in which a product incorporating or comprising as an active ingredient one or more Collaboration Compounds is sold to Third Parties other than licensees or sublicensees of PHARMA or its Affiliates.
Product Approval” shall mean all approvals necessary to market and sell a Product in a particular country or jurisdiction.
Regulatory Approval” means, with respect to a Product, the grant of all necessary permits, authorizations, licenses and approvals (or waivers) from the relevant Regulatory Authority required for the research, development, manufacture, marketing, storage, import, export, transport, use and sale of the Product in any country, group of countries or jurisdiction, including where required, pricing and reimbursement approvals.
Regulatory Authority” shall mean any applicable government regulatory authority whose approval is necessary to manufacture, market and sell a Product in the Territory, including, in the United States, the FDA.
Related Compounds” shall have the meaning described in Exhibit 1.D.
research” shall mean the scientific, technical and pre-clinical activities undertaken to evaluate a compound for development, including pre-clinical development.
Research Plan” shall mean the plan attached hereto as Exhibit 1.E. that describes the research activities to be performed by Genelabs and PHARMA and/or their Affiliates in conducting the Research Program, as such plan may be amended or modified from time to time in accordance with this Agreement.
Research Program” shall mean the research activities undertaken by either or both of the Parties hereto or their respective Affiliates, as set forth in Article 2 and the Research Plan.
Research Program Term” shall mean the duration of the Research Program, as set forth in Section 2.8.
Sales Report” shall mean a written report or reports setting forth: (a) the Net Sales of each Product in each country in the Territory during the reporting period by PHARMA, its Affiliates and sublicensees; (b) the royalties, payable in US Dollars, which shall have accrued under Section 5.5 in respect of such Net Sales and the basis of calculating those royalties; and (c) withholding taxes, if any, required by law to be deducted in respect of any such Net Sales.
“[**] of the HCV NS5b RNA polymerase” shall mean the [**].

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[ * *] = 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.
sPoC” shall mean the declaration by the Translational Research and Translational Development Board of PHARMA or its Affiliates (or the equivalent thereof), in its sole discretion, that the status “selection for proof of concept” (“sPoC”) (or the equivalent thereof) has been achieved with respect to a Collaboration Compound.
Territory” shall mean the entire world.
Third Party” shall mean any Person other than other than a Party or an Affiliate of a Party.
Third Party Collaboration” shall mean a license, purchase, research collaboration, co-promotion, co-development, co-marketing, co-detailing or any similar arrangement with a Third Party.
United States” or “US” means the United States of America, its territories and possessions, including, without limitation, the Commonwealth of Puerto Rico.
Valid Claim” shall mean (i) a claim of an issued patent that has not expired or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) or (ii) a claim within a patent application that has not been revoked, cancelled, withdrawn, held invalid or abandoned and which has not been pending for more than five (5) years from the date of its first filing.
1.2 Interpretation. In this Agreement, unless the context requires otherwise:
               (a) the headings are included for convenience only and shall not affect its construction;
               (b) words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;
               (c) references to the word “include” and “including” shall mean includes and including without limitation;
               (d) any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or re-enacted; and
               (e) the Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall, unless the context otherwise requires, include references to the Exhibits and attachments. In the event of any inconsistency between the Exhibits and the terms of this Agreement, the terms of this Agreement shall prevail.

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[ * *] = 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.
2. RESEARCH PROGRAM
     2.1 General.
          2.1.1 Purpose of Research Program. The purpose of the Research Program shall be to identify and synthesize Collaboration Compounds, as more fully described in the Research Plan. The Parties contemplate that, initially, the Research Program will focus on back-up and follow-on compounds to the existing Genelabs Compounds, and, if the Collaboration Field is expanded pursuant to Section 2.3, then to identify novel compounds within the scope of the expanded Collaboration Field.
          2.1.2 Research Plan. Genelabs and PHARMA shall engage in the Research Program upon the terms and conditions set forth in this Agreement. The activities to be undertaken in the course of Research Program are set forth in the Research Plan. The Research Plan may be amended from time to time upon approval of the Committee. The Research Plan shall specify the tasks to be conducted by the Parties, establish the scientific direction and research milestones of the Research Program, and allocate Research Program responsibilities and resources between the Parties in a manner consistent with this Agreement. In the event of any conflict between the Research Plan and this Agreement, this Agreement shall prevail.
          2.1.3 Responsibilities of Genelabs. Unless otherwise agreed by the Parties or specified in the Research Plan, Genelabs shall be responsible for lead optimization chemistry, biology, research pharmacokinetics and metabolism studies in rodents, and discovery of new Genelabs Compounds; provided that, for avoidance of doubt, once any Genelabs Compound has [**].
          2.1.4 Research Costs. Except as provided in Section 5.2, each Party shall bear its own costs and external payments to Third Parties that it incurs in the course of the Research Program.
     2.2 Conduct of Research. Subject to the terms and conditions of this Agreement, each Party shall be responsible for managing and controlling its personnel and the tasks assigned to it under the Research Plan. Each Party shall conduct the Research Program in good scientific manner, and in compliance with all requirements of applicable laws, rules and regulations to attempt to achieve their objectives efficiently and expeditiously. Each Party shall proceed diligently and in a timely manner with the work set out in the Research Program and shall allocate sufficient time, effort, equipment and facilities to the Research Program and use personnel with sufficient skills and experience as are required to accomplish the Research Program in accordance with the terms of this Agreement and the Research Plan. In no event shall Genelabs be obligated to devote to the Research Program more than the number of FTEs being funded by PHARMA under this Agreement. The Parties acknowledge and understand that neither Party guarantees the success of the Research Program undertaken hereunder.
     Either Party shall be entitled to utilize the service of Third Parties to perform Research Program activities only upon the prior written consent of the Committee (not to be unreasonably

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[ * *] = 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.
withheld) or as specifically set forth in the Research Plan, provided that (i) such Party shall obtain the written agreement of each such Third Party, prior to the time such Third Party initiates work, to assign ownership of Inventions made in the course of Research Program activities to such Party; (ii) each Party shall be responsible for the acts or omissions of any such Third Party which would constitute a breach of such Party’s obligations hereunder; (iii) any such Third Party shall comply with all relevant terms of this Agreement; and (iv) any such Third Party shall sign a confidentiality agreement with confidentiality and non-use obligations no less restrictive than those set forth in Article 4. Notwithstanding the above, in the event Genelabs desires to subcontract any research activities referred to in this paragraph, Genelabs shall first notify PHARMA thereof, and PHARMA shall have the right to perform such activities.
     2.3 Expansion of Collaboration Field.
          2.3.1 Right to Expand. At any time and from time to time during the Research Program Term, PHARMA shall have the right in its sole discretion, upon written notice to Genelabs, to expand the Collaboration Field to include Non-nucleoside inhibitors of the HCV NS5b RNA polymerase which are not then part of the Collaboration Field, except for any such inhibitors which are already subject to an exclusive Third Party Collaboration between Genelabs and a Third Party with respect to which Genelabs has provided PHARMA notice pursuant to and complied with the provisions of Section 2.3.2. For the avoidance of doubt, no additional upfront payments, funding of FTE’s or other compensation will be payable by PHARMA in consideration for the exercise of its right to expand the Collaboration Field pursuant to this Section 2.3.1.
          2.3.2 Proposed Third Party Collaborations.
          (a) If Genelabs or any Affiliate thereof, at any time and from time to time during the Research Program Term, desires to enter into a Third Party Collaboration with respect to the research, development and/or commercialization of any Non-nucleoside inhibitors of the HCV NS5b polymerase which are not then part of the Collaboration Field (a “Proposed Third Party Collaboration Field”), then each such time Genelabs shall promptly provide PHARMA with written notice thereof, which notice shall include all information and data in Genelabs’ possession or control relevant to the Proposed Third Party Collaboration Field or proposed Third Party Collaboration including all information proposed to be provided to Third Parties in contemplation of such Third Party Collaboration (the “Evaluation Information Package”).
          (b) For a period of [**] from the date of receipt of such notice and information (the “Option Exercise Period”), PHARMA shall have the right to expand the Collaboration Field pursuant to Section 2.3.1 to include the Proposed Third Party Collaboration Field upon written notice to Genelabs within the Option Exercise Period. During the Option Exercise Period, PHARMA shall have the Evaluation Rights hereinafter defined in order to determine whether it wishes to expand the Collaboration Field.
          (c) “Evaluation Rights” shall mean the following rights:

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[ * *] = 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.
               (i) To receive the Evaluation Information Package as provided above;
               (ii) To meet with and discuss the Proposed Third Party Collaboration Field with Genelabs’ and its Affiliates’ scientific personnel;
               (iii) To receive samples from Genelabs and its Affiliates of any compound(s) within the Proposed Third Party Collaboration Field to conduct tests on such compounds; and
               (iv) To conduct due diligence regarding the Proposed Third Party Collaboration Field.
     The exercise of the Evaluation Rights shall be conducted pursuant to industry standard confidential disclosure agreements and material transfer agreements to be entered into by Genelabs and PHARMA and/or their respective Affiliates. Until expiration of the Option Exercise Period, neither Genelabs nor its Affiliates shall (i) provide any Evaluation Rights to any Third Party or otherwise solicit or encourage (including by way of furnishing information or samples), or undertake discussions or negotiations, or take any other action to facilitate or consummate, any inquiries or the making of any proposal, relating to a Third Party Collaboration with respect to the Proposed Third Party Collaboration Field or (ii) enter into a Third Party Collaboration with respect to the Proposed Third Party Collaboration Field. For the avoidance of doubt, the foregoing shall not prohibit disclosures relating to the Proposed Third Party Collaboration Field at scientific conferences or investor conferences, subject to the provisions of Section 4.4. This Section 2.3.2 also shall not prevent Genelabs from entering into agreements relating to the Proposed Third Party Collaboration Field with vendors solely for such vendors to provide products or services to Genelabs.
          (d) In the event that PHARMA does not exercise its rights pursuant to Section 2.3.2(b) above with respect to the Proposed Third Party Collaboration Field within the Option Exercise Period, then Genelabs shall have the right, for a period of [**] following the expiration of the Option Exercise Period, to enter into a Third Party Collaboration with respect to the research, development and/or commercialization of compound(s) within the Proposed Third Party Collaboration Field. In the event that Genelabs does not enter into such a Third Party Collaboration within such [**] period, then, prior to Genelabs entering into a Third Party Collaboration with respect to such Proposed Third Party Collaboration Field or any portion thereof following the expiration of such [**] period, Genelabs shall be required to again comply with this Section 2.3.2 with respect to any proposed Third Party Collaboration relating to such Proposed Third Party Collaboration Field.
     2.4 Genelabs’ FTEs.
          2.4.1 Number of FTEs. During the Initial Research Program Term and the initial one (1) year extension, if any, pursuant to Section 2.8.1, Genelabs shall dedicate, and PHARMA shall fund, up to [**], but no fewer than [**] FTEs to the Research Program. All such FTEs shall be funded by PHARMA in accordance with Section 5.2. The specific number and

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[ * *] = 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.
identity of FTEs dedicated shall be as set forth in the Research Plan, provided that, except with Genelabs written consent, (a) Genelabs shall not be required to dedicate more than the maximum number of FTEs to the Research Program set forth above and (b) no more than [**] of the Genelabs personnel assigned to participate in the Research Program shall be required to be [**]. Except as set forth on Exhibit 2.5.2 or otherwise agreed by the Parties, [**].
          2.4.2 Qualifications. Genelabs shall ensure that each FTE that works on the Research Program is qualified by appropriate experience and qualifications to perform the Research Program work assigned to such FTE in a capable and professional manner.
     2.5 Joint Research Committee. The Parties shall establish a committee to function during the Research Program Term to oversee the Research Program as follows:
          2.5.1 Composition of the Joint Research Committee. Promptly after the Effective Date, the Parties shall establish a joint research committee (the “Committee”) composed of (i) three (3) named representatives of PHARMA and (ii) three (3) named representatives of Genelabs, one of which shall at all times during the Research Program Term be the Chief Scientific Officer of Genelabs. Each Party shall appoint its respective representatives to the Committee from time to time, and may substitute one or more of its representatives, in its sole discretion, effective upon notice to the other Party of such change. All Committee members shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Research Program. Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend Committee meetings, subject to such representative’s and consultant’s written agreement to comply with the confidentiality and non-use obligations equivalent to those set forth in Article 4, and provided that such additional representatives shall have no vote. Each Party shall bear its own expenses related to the attendance of such meetings by its representatives. PHARMA shall have the right to appoint one of its representatives on the Committee to act as chairperson of the Committee. The chairperson shall set agendas for Committee meetings, provided that the agendas will include any matter requested by either Party. Notwithstanding the foregoing, each Party shall have the right to have its own internal project team with regard to research activities under this Agreement, which will not include any representation from the other Party.
          2.5.2 Decision-Making Authority. The Committee shall oversee all activities conducted pursuant to the Research Program, including scientific and technical matters related to the conduct of the Research Program. Without limiting the foregoing, the Committee shall have authority and responsibility for (i) determining a staffing plan to include number, function and level of FTEs and PHARMA research personnel devoted to the Research Program (subject to the requirements of Section 2.4.1); (ii) periodic review of goals and strategic direction; (iii) prioritizing the allocation of resources dedicated to the Research Program; and (iv) consideration of changes to the Research Program. The Committee will cease to have authority with respect to any Collaboration Compound and/or Product which has achieved sPoC, at which point PHARMA shall have sole authority and responsibility for all further activities with respect to such Collaboration Compound and/or Product. Subject to Section 2.5.3,

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[ * *] = 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.
decisions of the Committee shall be made by majority vote, with each Party’s representatives on the Committee collectively having one (1) vote. In no event shall the Committee have the right:
               (a) to modify or amend the terms and conditions of this Agreement;
               (b) to determine which personnel of a Party perform Research Program activities or act as such Party’s representatives on the Committee, except that it is agreed that each of the individuals listed on Exhibit 2.5.2 shall work on the Research Program, for at least the percentage of time specified, during the Research Term as a Genelabs FTE for so long as such individual is an employee of Genelabs or an Affiliate thereof;
               (c) to modify or amend the Research Plan in any manner that would require Genelabs to devote a number of FTEs to the Research Program other than that specified in, or agreed upon in accordance with, Section 2.4 or to incur expenses not contemplated by this Agreement;
               (d) to modify or amend the Research Plan or Research Program to direct activities outside of the Collaboration Field (other than any activities outside of the Collaboration Field relating to then-existing Collaboration Compounds); or
               (e) to determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement.
     Upon expiration or termination of the Research Program Term, the Committee shall disband.
          2.5.3 Disputes. In the event that the Committee cannot or does not reach agreement on an issue, the members of the Committee shall attempt in good faith to resolve such issue. If they cannot resolve such issue within thirty (30) days of commencing such negotiations, then the issue shall be discussed by the Chief Executive Officer of Genelabs and the President of PHARMA (or, in each case, a designee with similar authority to resolve a dispute hereunder). In the event such individuals are unable to resolve such issue within thirty (30) days following the referral of such dispute to them, such resolution of the issue and/or course of conduct shall be determined by PHARMA.
          2.5.4 Meetings. The Committee shall meet in accordance with a schedule established by mutual written agreement of the Parties, but no less frequently than once per Calendar Quarter, alternating between Genelabs’ facilities and PHARMA’s facilities in the United States (or such other location as is mutually agreed by the Parties). Alternatively, the Committee may meet by means of teleconference, videoconference or other similar communications equipment, provided that at least one (1) meeting per Calendar Year will be in person. The Committee shall confer regarding the status of the Research Program, review relevant data, consider and advise on any technical issues that arise, set research priorities, and review and advise on any budgetary and economic matters relating to the Research Program

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which is referred to the Committee. No Committee meeting may be conducted unless at least one (1) representative of each Party is participating. Each Party shall bear all costs and expenses, including travel expenses, relating to the participation by its respective Committee members in such meetings.
          2.5.5 Minutes. The chairperson of the Committee will be responsible for recording, preparing and, within a reasonable time, issuing draft minutes of each Committee meeting, which draft minutes shall be subject to review and approval by the Committee promptly.
          2.5.6 Project Leaders. PHARMA and Genelabs each shall appoint a person (a “Project Leader”) from the Committee to coordinate its part of the Research Program. The Project Leaders shall be the primary contact between the Parties with respect to the Research Program. Each Party shall notify the other Party as soon as practicable upon changing this appointment.
     2.6 Exchange of Information.
          (a) Upon execution of this Agreement, and from time to time as necessary or as reasonably requested from time to time by PHARMA during the Research Program Term, Genelabs and its Affiliates [**], shall disclose and/or provide reasonable amounts of samples of to PHARMA or its designated Affiliate in English all Genelabs Know-How, including but not limited to [**] and such Genelabs Background Know-How as is necessary or useful (i) for the performance by PHARMA or its Affiliates of PHARMA’s responsibilities under the Research Program, (ii) in order to permit it to continue conducting research activities hereunder following expiration or termination of the Research Program and consistent with the licenses granted in Section 3.1(a) and/or (iii) for PHARMA or its Affiliates to develop, manufacture, register, use or market the Collaboration Compounds and Products in the Field and practice the licenses granted hereunder efficiently. As part of such disclosure, as soon as reasonably practicable, Genelabs and its Affiliates [**], will disclose to PHARMA or its designated Affiliate all existing Genelabs Know-How which is reasonably relevant to the manufacture and development of Collaboration Compounds and Products, including [**]. Within ten (10) days of the execution of this Agreement, Genelabs [**], shall provide PHARMA with a written description of all Genelabs Compounds heretofore synthesized by or for Genelabs.
          (b) From time to time as necessary during the Research Program Term, PHARMA and its Affiliates shall disclose to Genelabs or its designated Affiliate such PHARMA Know-How not previously disclosed and such PHARMA Background Know-How as is reasonably necessary, in PHARMA’s reasonable judgment, for the performance by Genelabs of its responsibilities under the Research Program.
     2.7 Records and Reports.
          2.7.1 Records. Genelabs and PHARMA each shall maintain, or cause to be maintained, records of its respective activities under the Research Program in sufficient detail

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and in good scientific manner appropriate for Patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective activities under the Research Program, and which shall be retained by such Party for at least [**] years after the termination or expiry of this Agreement, or for such longer period as may be required by applicable law.
          2.7.2 Copies and Inspection of Records. No more frequently than once each Calendar Year during the Research Program Term and for six (6) months thereafter, PHARMA shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of Genelabs and its Affiliates referred to in Section 2.7.1; provided, however, that PHARMA shall not have the right to review or copy records to the extent that such records contain information that does not relate to the Research Program, in which case Genelabs shall use reasonable efforts to provide such records in redacted form to eliminate such unrelated information, and Genelabs, in lieu of providing such access to its records, may elect to provide copies of the relevant records to PHARMA. PHARMA shall maintain such records and the information disclosed therein in confidence in accordance with Section 4.1.
          2.7.3 Research Reports. Not later than five (5) Business Days before each scheduled quarterly Committee meeting during the Research Program Term, Genelabs shall provide to PHARMA a written progress report in English which shall describe the work performed by Genelabs to date on the Research Program, evaluate the work performed in relation to the goals of the Research Program and provide such other information required by the Research Program or reasonably requested by PHARMA relating to the progress of the goals or performance of the Research Program. Without limiting the generality of the foregoing, each such progress report will disclose any Collaboration Compounds or Collaboration Technology made by Genelabs during such Calendar Quarter. Nothing herein shall require Genelabs to disclose information, if any, received from a Third Party which remains subject to confidentiality obligations to such Third Party. Within thirty (30) days after expiration or termination of the Research Program Term, Genelabs shall deliver to PHARMA a final report.
          2.7.4 Documentation of Inventions; Information Security. To protect Patents under US law in any Inventions within the Research Program, each Party agrees to maintain a policy which requires its employees to record and maintain all data and information developed during the Research Program in such a manner as to enable the Parties to use such records to establish the earliest date of invention and/or diligence to reduction to practice, and to assign ownership of all Inventions to the Party. At a minimum, the policy shall require such individuals to record all inventions generated by them in Novartis External Collaboration Laboratory Notebooks (or their equivalent) that are dated and corroborated by non-inventors on a regular, contemporaneous basis. In addition, Genelabs will maintain appropriate information security, quality assurance and data integrity procedures that are reasonably acceptable to PHARMA.

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     2.8 Research Program Term; Termination.
          2.8.1 Research Program Term. Except as otherwise provided herein, the Research Program Term shall commence on the Effective Date and continue for a period of two (2) years thereafter (the “Initial Research Program Term”). PHARMA may, in its sole discretion, extend the Research Program Term for up to an additional one (1) year by providing Genelabs with written notice of such election at least six (6) months prior to the expiration of the Initial Research Program Term. In the event of such election by PHARMA, the Parties shall in good faith agree upon any necessary amendments to the Research Plan, as applicable, including, without limitation, the number of Genelabs FTEs to be committed and funded by PHARMA for such extended term. Thereafter, the Parties may extend the Research Program Term by mutual written agreement of the authorized representative of the Parties. In such case, the Parties shall amend the Research Plan as applicable.
          2.8.2 Termination of Research Program. The Research Program (and thereby the Research Program Term) may be terminated by PHARMA in its sole discretion upon written notice to Genelabs in the event of the occurrence of any of the following:
          (a) pursuant to Section 11.2.3 in the event of a Change of Control of Genelabs involving a Competitor;
          (b) the Bankruptcy of Genelabs or the default by Genelabs or any of its Affiliates under any long term indebtedness (as defined in accordance with Genelabs’ Accounting Standards);
          (c) the [**], as determined by the Committee;
          (d) the average actual number of FTEs working on the Research Program over any given [**] period is less than [**] percent ([**] %) of the number specified for such period in the Research Plan;
          (e) [**] within the twelve (12) month period following such date; or
          (f) Genelabs for any reason fails to have adequate facilities to fully perform the Research Program and fails to relocate to other adequate facilities within sixty (60) days of such failure. [**].
     PHARMA shall provide Genelabs ten (10) days prior written notice of its intent to terminate under subsections (c), (d), (e) or (f) in order to allow Genelabs to provide a response thereto. Upon such termination, all other provisions of this Agreement applicable to the period following the Research Program Term shall continue in force.

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[ * *] = 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.
     2.9 Compliance.
          (a) Each Party shall conduct its activities under the Research Program in accordance with all applicable laws, rules and regulations, including, for those activities which are required to be conducted thereunder, all current governmental regulatory requirements concerning Good Laboratory Practices. In addition, if animals are used in research hereunder, each Party will comply with the Animal Welfare Act as Amended (7 U.S.C., 2131-2159) or any other applicable local, state, national and international laws or regulations relating to the care and use of laboratory animals. At all times during the Research Program, Genelabs, without any additional consideration, shall provide PHARMA upon request with copies of its IACUC protocol approvals and other documentation applicable to work under the Research Program and PHARMA representatives shall have the right to inspect Genelabs’ animal facilities and review its animal welfare procedures and documentation. Such Genelabs procedures shall be consistent with the “Guide for the Care and Use of Laboratory Animals” (ILAR) and follow AAALAC or OLAW guidelines, however, PHARMA understands that Genelabs is not accredited by AAALAC or registered with OLAW. “IACUC” shall mean Institutional Animal Care and Use Committee. “ILAR” shall mean Institute of Laboratory Animal Resources. “AAALAC” shall mean the Association for Assessment and Accreditation of Laboratory Animal Care International. “OLAW” shall mean the Office of Laboratory Animal Welfare.
          (b) Each Party shall notify the other Party in writing of any deviations from applicable regulatory or legal requirements arising from its conduct of the Research Program. Each Party agrees that in performing its obligations under the Research Program, it will not employ or use any person that has been debarred under Section 306(a) or 306(b) of the US Federal Food, Drug and Cosmetic Act.
     2.10 Liability. In connection with the conduct of the Research Program, each Party shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage attributable to the negligent acts or omissions of that Party or its Affiliates, and their respective directors, officers, employees, contractors and agents.
     2.11 Materials.
          (a) In order to facilitate the Research Program, each Party shall provide the other Party with sufficient quantities of Collaboration Compounds and other biological or chemical materials as set forth in the Research Plan (“Materials”). Except as otherwise provided under this Agreement, all such Materials delivered to the other Party shall remain the sole property of the supplying Party, shall be used only in furtherance of the Research Program and solely under the control of the other Party (or its Affiliates) except as provided below. Each Party shall use the Materials supplied by the other Party solely for the purposes of carrying out its respective activities under the Research Program in accordance with the terms of this Agreement and, in the case of PHARMA, of developing and commercializing Collaboration Compounds and Products in accordance with this Agreement. Neither Party shall transfer, deliver or disclose any such Materials of the other Party, or any derivative, modification or component thereof, to any Third

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Party without the prior written approval of the providing Party, except that: (a) Genelabs may transfer Materials provided by PHARMA to Genelabs’ subcontractors of its Research Program activities as permitted in accordance with Section 2.2 with PHARMA’s prior written consent for the sole purpose of performing such Research Program activities; and (b) PHARMA may transfer Materials provided by Genelabs (i) to PHARMA’s permitted subcontractors of Research Program activities with Genelabs’ prior written consent for the sole purpose of performing such Research Program activities, or (ii) to academic institutions with Genelabs’ prior written consent and subject to appropriate restrictions on use. It is understood that PHARMA may transfer Collaboration Compounds to Third Parties without Genelabs’ consent for Preclinical Development, clinical development and commercialization, subject to appropriate restrictions on use. The Materials supplied under this Section 2.11 are supplied “as is” and must be used with prudence and appropriate caution, since not all of their characteristics may be known. The Materials are not to be used in humans, except as contemplated by this Agreement and permitted by applicable law.
          (b) Upon expiration or termination of the Research Program Term, Genelabs shall, at PHARMA’s option, deliver to PHARMA or destroy (in accordance with instructions from PHARMA) any unused Materials supplied by PHARMA, and any derivatives, modifications or components thereof. Upon any termination of this Agreement by PHARMA pursuant to Section 9.2 or by Genelabs pursuant to Section 9.3, PHARMA shall, at Genelabs’ option, deliver to Genelabs or destroy any unused Materials supplied by Genelabs, and any derivatives, modifications or components thereof. PHARMA also may retain Collaboration Compounds and Products in the quantities and for the times required by Regulatory Authorities.
     2.12 Scope of this Agreement. It is anticipated that in the course of activities under this Agreement, the Parties may solely or jointly develop Inventions, which Inventions may be PHARMA Background Technology, Genelabs Background Technology, Joint Technology or Collaboration Technology, and all of which shall be deemed within the scope of this Agreement pursuant to the Cooperative Research and Technology Enhancement (CREATE) Act of 2004.
3. LICENSE; DEVELOPMENT AND COMMERCIALIZATION; EXCLUSIVITY
     3.1 License Grant.
          (a) Licenses to PHARMA. Subject to the terms and conditions of this Agreement, Genelabs hereby grants to PHARMA (i) an exclusive (even as to Genelabs), royalty-bearing (as set forth in Section 5.5) license, with the right to sublicense, under Genelabs Technology to make, manufacture, formulate, research, develop, register, transport, use, sell, offer for sale, import, export, distribute, promote, market, otherwise commercialize or dispose or offer to commercialize or dispose, and have any of the foregoing done on its behalf, of Products and/or Collaboration Compounds in the Field in the Territory, whether through itself, its Affiliates and/or its sublicensees; provided, however, that Genelabs retains such non-exclusive rights under Genelabs Technology as are necessary to perform its obligations under the Research Program and (ii) a non-exclusive, royalty-free license, without the right to sublicense (other than

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to permitted subcontractors), under the Genelabs Background Technology to research, develop and manufacture Collaboration Compounds and Products.
          (b) Licenses to Genelabs. Subject to the terms and conditions of this Agreement, PHARMA hereby grants to Genelabs a non-exclusive, royalty-free license, without the right to sublicense (other than to permitted subcontractors), under PHARMA Background Technology solely to the extent necessary for Genelabs and its Affiliates to perform Genelabs’ obligations under the Research Program during the Research Program Term and consistent with the Research Plan.
          (c) License Limitations. Each Party covenants to the other Party that it shall not practice, exercise or use any intellectual property rights licensed to it by the other Party under this Agreement, except as permitted by the express terms of the licenses granted in this Agreement.
     3.2 Negative Covenants; No Implied Licenses.
          (a) No right or license under any Patents or Know-How of either Party or its Affiliates is granted or shall be granted by implication or estoppel. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement.
          (b) Neither Genelabs nor any of its Affiliates shall itself or in collaboration with any Third Party conduct Preclinical Development or clinical development or commercialization of any Collaboration Compound, except as provided in this Agreement or as otherwise agreed in writing by PHARMA.
     3.3 Development and Commercialization; Diligence.
          (a) As between PHARMA and Genelabs, and unless otherwise set forth in the Research Plan, PHARMA, whether through itself, its Affiliates and/or its sublicensees, shall be solely responsible, at its own cost and in its sole discretion, for all Preclinical Development, clinical development, chemistry, manufacturing, controls, manufacturing of preclinical, clinical and commercial materials, filing and prosecution of all applications for Regulatory Approval, and other commercialization of Collaboration Compounds and/or Products.
          (b) PHARMA shall use Commercially Reasonable Efforts to develop and commercialize, whether through itself, its Affiliates and/or its sublicensees [**].
     3.4 Excused Performance. In addition to the provisions of Section 11.1, and notwithstanding any other provision hereof, PHARMA’s obligations under Section 3.3 may be delayed or suspended at such time and for so long as PHARMA determines in good faith that there exists any safety (including toxicity), efficacy, regulatory, technical, medical, or legal or similar issue or issues regarding the competitive position of the applicable Collaboration Compound or Product that could adversely affect a Collaboration Compound or Product.

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[ * *] = 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.
     3.5 Reports on PHARMA Efforts. PHARMA will keep Genelabs reasonably informed about PHARMA’s development and commercialization efforts with respect to Collaboration Compounds and Products. During the Research Program Term, such obligation shall be satisfied through discussions of the Committee. Thereafter, no less frequently than [**], PHARMA shall provide Genelabs with a written report specifying the occurrence of any of the following:
          (a) the grant of any exclusive sublicense of PHARMA’s rights hereunder (including the identity of the sublicensee and the scope of the sublicense) and the termination of any such sublicense;
          (b) the filing of an IND or NDA with respect to any Collaboration Compound or Product in any jurisdiction;
          (c) commencement of Preclinical Development, Phase I Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials with respect to any Collaboration Compound or Product in any jurisdiction; and
          (d) the obtainment of Regulatory Approvals with respect to any Product in a country in the Major Markets.
     3.6 NS5a Program Rights.
          (a) Genelabs shall provide to PHARMA a written notice (the “NS5a Notice”) upon the earlier of (i) Genelabs’ determination that it or any of its Affiliates has a compound which is suitable for Preclinical Development in its NS5a Program in accordance with its internal standards therefor; or (ii) Genelabs’ determination to seek a Third Party Collaboration with respect to the research, development or commercialization of any of the NS5a Assets (such compound or NS5a Assets, the “Subject NS5a Assets”). If within thirty (30) days after receipt of the NS5a Notice, PHARMA notifies Genelabs in writing (the “PHARMA Notice”) that it wishes to enter into negotiations to license the Subject NS5a Assets, then for one hundred twenty (120) days (the “Negotiation Period”) after receipt of the information package specified in paragraph (b)(i) below from Genelabs, PHARMA shall have the Negotiation Rights hereinafter defined. If PHARMA does not send the PHARMA Notice within such thirty (30) day period, then PHARMA shall have no further rights under this Section 3.6 with respect to such Subject NS5a Assets, subject to Section 3.6(d).
          (b) “Negotiation Rights” shall mean the following rights:
               (i) To request and receive an information package from Genelabs and its Affiliates pertaining to the Subject NS5a Assets, which shall include information owned or Controlled by Genelabs or its Affiliates sufficient to enable PHARMA to reasonably evaluate the Subject NS5a Assets, including but not limited to [**]. Genelabs may exclude from such information package structural information on compounds for which a patent application has not yet been filed; provided that PHARMA shall have the right to retain Third Party consultants, who shall be reasonably acceptable to Genelabs, to

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review and otherwise conduct due diligence and advise PHARMA with respect to such structural information, provided that such consultants shall not be permitted to disclose such structural information to PHARMA or its Affiliates;
               (ii) To meet with and discuss the Subject NS5a Assets and the NS5a Program with Genelabs’ and its Affiliates’ scientific personnel;
               (iii) To receive samples from Genelabs and its Affiliates of any lead compound(s) included in the Subject NS5a Assets and to conduct tests on such compounds (but not procedures to determine the structures of such compounds);
               (iv) To conduct due diligence regarding the Subject NS5a Assets; and
               (v) To negotiate the terms with Genelabs for an exclusive license to the Subject NS5a Assets.
          (c) The exercise of the Negotiation Rights shall be conducted pursuant to industry standard confidential disclosure agreements and material transfer agreements to be entered into by Genelabs and PHARMA and/or their respective Affiliates. During the Negotiation Period, Genelabs and PHARMA shall negotiate in good faith on the terms of an exclusive license of the Subject NS5a Assets. Until the expiration of the Negotiation Period, neither Genelabs nor its Affiliates shall (i) provide any Negotiation Rights to any Third Party, (ii) enter into a confidentiality agreement with or disclose any confidential information to any Third Party with respect to the Subject NS5a Assets or (iii) enter into a Third Party Collaboration or discuss any business terms of a proposed Third Party Collaboration with a Third Party with respect to the Subject NS5a Assets. For the avoidance of doubt, the foregoing shall not prohibit disclosures relating to the Subject NS5a Assets at scientific conferences or investor conferences, subject to the provisions of Section 4.4. This Section 3.6(b) also shall not prevent Genelabs from entering into agreements relating to the Subject NS5a Assets with vendors solely for such vendors to provide products or services to Genelabs.
          (d) In the event that (i) PHARMA does not provide the PHARMA Notice within thirty (30) days after receiving the NS5a Notice or (ii) PHARMA provides the PHARMA Notice within thirty (30) days after receiving the NS5a Notice, but the Parties or their designated Affiliates do not enter into a license agreement for the Subject NS5a Assets within the Negotiation Period (despite having negotiated good faith), then Genelabs shall have the right, for a period of [**] following either (x) the date which is thirty (30) days following PHARMA’s receipt of the NS5a Notice, in the event of clause (i) above, or (y) the date of the expiration of the Negotiation Period, in the event of clause (ii) above, to initiate Preclinical Development of the applicable compound(s) or enter into a Third Party Collaboration with respect to the Subject NS5a Assets, as the case may be. In the event that Genelabs does not initiate Preclinical Development of the applicable compound(s) or enter into such a Third Party Collaboration within such [**] period, then, prior to Genelabs initiating Preclinical Development or entering

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into such a Third Party Collaboration with respect to such compound(s) or Subject NS5a, Genelabs shall be required again to comply with this Section 3.6.
     3.7 Exclusivity.
          (a) During the Exclusivity Period, neither Genelabs nor PHARMA shall, directly or indirectly, on its own behalf or with a Third Party, research, develop, commercialize, distribute, market or sell (or license or otherwise grant rights to a Third Party to do any of the foregoing) in the Territory Non-nucleoside compounds in the Collaboration Field, except for activities conducted pursuant to and in accordance with this Agreement.
          (b) Notwithstanding the foregoing, Section 3.7(a) shall not apply with respect to any compound in the Collaboration Field which was being researched, developed, commercialized, distributed, marketed or sold (alone or in collaboration with a Third Party) by an Excluded Affiliate of a Party prior to the time such Excluded Affiliate becomes an Affiliate of such Party.
          (c) For purposes of this Section 3.7, any act or activity undertaken, or failure to act, by an Affiliate of a Party, which, if committed by such Party would constitute a breach of this Section 3.7, shall constitute a breach by such Party.
4. CONFIDENTIALITY AND PUBLICATION
     4.1 Nondisclosure Obligation.
          (a) All Information disclosed by one Party or its Affiliates to the other Party or its Affiliates hereunder (“Confidential Information”) shall be maintained in confidence by the receiving Party and its Affiliates and shall not be disclosed to any Third Party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the disclosing Party, except to the extent that the receiving Party can demonstrate that such Information:
               (i) is known by the receiving Party or its Affiliates at the time of its receipt, and not through a prior disclosure by the disclosing Party or its Affiliates, as documented by the receiving Party’s or its Affiliates’ business records;
               (ii) is in the public domain other than as a result of any breach of this Agreement by the receiving Party or its Affiliates;
               (iii) is subsequently disclosed to the receiving Party or its Affiliates on a non-confidential basis by a Third Party who may lawfully do so; or
               (iv) is independently discovered or developed by the receiving Party or its Affiliates without the use of Confidential Information provided by the disclosing Party or its Affiliates, as documented by receiving Party’s or its Affiliates’ business records.

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[ * *] = 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.
          (b) Within thirty (30) days after any expiration or termination of this Agreement, each Party shall destroy (and certify to the other Party such destruction) or return all Confidential Information provided by the other Party or its Affiliates except as otherwise set forth in this Agreement, and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information.
     4.2 Permitted Disclosures. Each Party and its Affiliates may disclose Confidential Information provided by the other Party or its Affiliates to the extent such disclosure is reasonably necessary in the following instances:
          (a) disclosure to governmental or other regulatory agencies in order to obtain patents on Collaboration Technology, Joint Technology, PHARMA Background Technology and/or Genelabs Background Technology or to gain or maintain approval to conduct clinical trials or to market Product (in each case to the extent permitted by this Agreement), but such disclosure may be only to the extent reasonably necessary to obtain patents or authorizations;
          (b) complying with applicable court orders or governmental regulations;
          (c) disclosure by PHARMA to its Affiliates for the sole purpose of conducting development and/or commercialization of Collaboration Compounds and Products in accordance with the terms and conditions of this Agreement on the condition that such Affiliates agree to be bound by confidentiality and non-use obligations at least equivalent in scope to those contained in this Agreement; or
          (d) disclosure to consultants, agents or other Third Parties solely to the extent required to accomplish the purposes of this Agreement or in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, in each case on the condition that such Third Parties agree to be bound by confidentiality and non-use obligations at least equivalent in scope to those contained in this Agreement or for the purposes of such financing.
          Each Party shall obtain written agreements from each of its employees and consultants who perform work on the Research Program, to the extent that the equivalent of such agreements are not already in place, which agreements shall obligate such Persons to similar obligations of confidentiality and to assign to such Party all inventions made by such Persons during the course of performing the Research Program.
          If a Party or its Affiliate is required by judicial or administrative process to disclose Information that is subject to the non-disclosure provisions of Section 4.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 4, and the Party or Affiliate disclosing Information pursuant to law or court order shall take all reasonable steps necessary, including

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without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Information.
     4.3 Publications. The Parties acknowledge that scientific lead time is a key element of the value of the Research Program and further agree that scientific publications must be strictly monitored to prevent any adverse effect of the premature publication of results of the Research Program. The Parties shall establish a procedure for publication review and approval with respect to publications regarding the Research Program and each Party shall first submit to the other Party an early draft of all such publications, whether they are to be presented orally or in written form, at least sixty (60) days prior to submission for publication, submissions of an abstract on the presentation, as the case may be. Each Party shall review each such proposed publication in order to avoid the unauthorized disclosure of a Party’s Confidential Information and to preserve the patentability of inventions arising from the collaboration. If, as soon as reasonably possible but no longer than thirty (30) days following receipt of an advance copy of a Party’s proposed publication, the other Party informs such Party that its proposed publication contains Confidential Information of the other Party, then such Party shall delete such Confidential Information from its proposed publication. If, as soon as reasonably possible but no longer than thirty (30) days following receipt of an advance copy of a Party’s proposed publication, the other Party informs such Party that its proposed publication could be expected to have a material adverse effect on any Patents or Know-How of such other Party, then such Party shall delay such proposed publication for a period of reasonable length to permit the timely preparation and first filing of Patent application(s) on the information involved. For the avoidance of doubt, the provisions of this Section 4.3 are not intended to govern or limit submissions reasonably necessary for Regulatory Approvals, press releases, submissions in connection with the filing, prosecution and maintenance of Patents, and the like.
     4.4 Publicity. Neither Party shall issue any press release or public announcement or disclosure relating to this Agreement or the terms hereof, the Research Program or any Products without the prior written approval of the other Party, which approval shall not be unreasonably withheld, except that a Party may issue such a press release or public announcement or disclosure if required by law, including by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or NASDAQ; provided that the other Party has received prior notice of such intended press release or public announcement or disclosure and the Party subject to the requirement includes in such press release or public announcement or disclosure only such information relating to the Product(s) or this Agreement as is required by such law. Without limiting the foregoing, each Party shall consult with the other Party on the provisions of this Agreement and the Research Plan, together with exhibits or other attachments attached thereto, to be redacted in any filings made by Genelabs and/or PHARMA with the Securities and Exchange Commission or as otherwise required by law. The rights of approval and notice granted to a Party in accordance with the preceding sentence shall only apply for the first time that specific information is to be disclosed, and shall not apply to the subsequent disclosure of substantially similar information that has previously been disclosed.

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5.   PAYMENTS; ROYALTIES AND REPORTS
     5.1 Upfront Fee.
          (a) Upon execution of this Agreement, PHARMA shall be obligated to make a one-time, non-refundable, non-creditable payment to Genelabs of US Four Million Dollars (US$4,000,000) in consideration for [**], payable within seven (7) days following receipt by PHARMA of an invoice in the form of Exhibit 5.1.
          (b) Upon execution of this Agreement, PHARMA shall be obligated to make a one-time, non-refundable, non-creditable payment to Genelabs of US Eight Million, Five Hundred Thousand Dollars (US$8,500,000) in consideration for [**], payable within seven (7) days following receipt by PHARMA of an invoice in the form of Exhibit 5.1.
     5.2 FTE Rate and Funding.
          (a) FTE Rate. The “FTE Rate” shall mean the rate at which PHARMA will reimburse Genelabs during the Research Program Term to support one (1) Genelabs FTE in the Research Program. The FTE Rate will be US [**] Dollars (US$[**]) per FTE. The foregoing FTE Rate shall include all personnel, equipment, reagents and all other expenses including support staff, overhead and travel expenses for or associated with an FTE, provided that payment by PHARMA of the FTE Rate shall not be deemed to give PHARMA any ownership interest in any equipment, reagents or other property purchased by Genelabs using such research funding.
          (b) FTE Funding. In consideration for Genelabs’ performance of its obligations under the Research Program, upon the terms and conditions contained herein, PHARMA shall reimburse Genelabs for the cost of each FTE provided by Genelabs pursuant to Section 2.3 at the FTE Rate. The amounts to be paid under this Section 5.2 shall be reimbursed by PHARMA quarterly in arrears, each installment equal to one-quarter of the FTE Rate multiplied by the actual number of FTEs devoted to the Research Program during the Calendar Quarter; provided that the FTE payment for (a) the first Calendar Quarter shall be prorated from the Effective Date and (b) the final Calendar Quarter during the Research Program Term shall be pro rated to the date of expiration or termination of the Research Program Term. Following the expiration of each Calendar Quarter during the Research Program Term, Genelabs shall provide to PHARMA an invoice substantially in the form of Exhibit 5.1 for all amounts due pursuant to this Section 5.2 for such Calendar Quarter in accordance with the Research Plan and detailed by activities performed by each FTE. Payments on such invoices shall be made within [**] days of PHARMA’s receipt of the applicable invoice.
     5.3 Milestone Payments. As additional consideration for the licenses granted by Genelabs to PHARMA hereunder, PHARMA shall be obligated to pay to Genelabs the non-refundable, non-creditable (except as specifically provided in this Agreement or in Exhibit 5.3) milestone payments (whether such milestone is achieved by PHARMA, or its Affiliate or sublicensee under this Agreement) set forth on Exhibit 5.3 (“Milestone Payments”).

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     5.4 Payment of Milestone Payments.
          (a) Subject to Section X5.3.4 in Exhibit 5.3, each of the Milestone Payments described in Exhibit 5.3 shall be payable [**]. For any Collaboration Compound, a Milestone Payment shall be payable upon the initial achievement of the applicable milestone and no amounts shall be due hereunder for subsequent or repeated achievement of such milestone by the same or any other Collaboration Compound.
          (b) PHARMA shall notify Genelabs in writing within thirty (30) days upon the achievement of each milestone. After receipt of such notice (if applicable), Genelabs shall submit an invoice to PHARMA substantially in the form of Exhibit 5.1 with respect to the corresponding Milestone Payment. PHARMA shall make the Milestone Payment within [**] after receipt of such invoice.
     5.5 Royalties.
          (a) Royalties. As additional consideration for the licenses granted by Genelabs to PHARMA hereunder, subject to the terms and conditions of this Agreement, PHARMA shall pay to Genelabs a royalty on annual Calendar Year worldwide Net Sales of each Product [**] by PHARMA, its Affiliates and sublicensees, in accordance with the royalty rates set forth below:
          [**]
          (b) Royalty Term; Reduction in Rate. Royalties will be payable on a Product-by-Product and country-by-country basis until the later of (i) the expiration of the last to expire Valid Claim of (A) with respect to a Product containing a Genelabs Compound, Genelabs Patents covering the composition of matter of such Product, the use for which such Product is being sold in such country or the manufacture or formulation of such Product or (B) with respect to a Product containing a PHARMA Compound, PHARMA Patents covering the composition of matter of such Product or the use for which such Product is being sold in such country or (ii) ten (10) years from the First Commercial Sale of such Product in such country (“Royalty Term”); provided that for any period during the Royalty Term following the expiration of the last to expire Valid Claim described in clause (i) above, then the royalty applicable to Net Sales of the applicable Product in such country thereafter for the remainder of the Royalty Term for such Product in such country shall be reduced by [**]. Following the Royalty Term on a Product-by-Product and country-by-country basis, PHARMA’s licenses with respect to such Product shall continue in effect, but become fully paid-up, royalty-free, transferable, perpetual and irrevocable.
          (c) Application of Royalty for Different Products. For the avoidance of doubt, the calculation of royalties under this Section 5.5 shall be conducted [**]. Thus, if PHARMA, its Affiliates, or sublicensees sell more than one Product in the Territory, any applicable thresholds and ceilings in this Section 5.5 shall [**]. For the purposes of this Section 5.5, any Products which contain as an active ingredient the same Collaboration Compound shall be considered one Product.

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          (d) Third Party Obligations. In the event PHARMA is required to obtain a license from any Third Party under any Patent or other intellectual property right of such Third Party and is obligated to pay a royalty to such Third Party or is liable for damages, license fees or other payments to such Third Party because PHARMA’s exercise of the license hereunder infringes or is alleged to infringe such Patent or other intellectual property rights of such Third Party, then, as between Genelabs and PHARMA, PHARMA shall in the first instance be responsible for such Third Party amounts owed, but shall have the right to deduct [**] of the amount of such royalties, damages, license fees and other payments (“Third Party Payments”) from any payments due for [**] and any royalties payable to Genelabs pursuant to this Agreement; provided, that in no event shall any credits or deductions under this Section 5.5(d) or any other provision of this Agreement in any Calendar Quarter exceed [**] of (i) the [**] against which the credit or deduction is being applied, or (ii) the aggregate royalties payable to Genelabs in such Calendar Quarter (such limits in (i) and (ii) shall be referred to as the “Agreed Limit”). Any portion of the Third Party Payments that PHARMA is entitled to deduct in accordance with the foregoing but which PHARMA is unable to deduct in any Calendar Quarter due to application of the Agreed Limit shall be rolled forward and deducted in the next Calendar Quarter for purposes hereof (subject to the Agreed Limit in such next Calendar Quarter) and so on until PHARMA has fully deducted Genelabs’ portion of such Third Party Payments. For the avoidance of doubt, nothing in this Section 5.5(d) shall be construed to prohibit PHARMA from pursuing any and all remedies available to it or recovering the full amount of damages sustained as a result of a breach by Genelabs of its representation and warranty set forth in Section 6.2(h).
          (e) Genelabs Third Party Obligations. Notwithstanding Section 5.5(d), Genelabs shall remain responsible for the payment of all royalty and other obligations, if any, due to Third Parties under Genelabs Patents or Genelabs Know-How which are licensed to Genelabs and are sublicensed to PHARMA hereunder. All such payments shall be made promptly by Genelabs (but in any event within the time period required under the applicable license or other agreement). Genelabs will not be entitled to add such royalties due to Third Parties to the royalty rates set forth in Section 5.5(a).
          (f) Substantial Generic Competition. In the event that substantial generic competition in the sale of a Product arises in any country, the royalties due in said country pursuant to this Agreement shall be reduced by [**]. Such reduction shall commence with the beginning of the first full Calendar Quarter following PHARMA’s written notification to Genelabs of the existence of such substantial generic competition. Substantial generic competition as used in this Section 5.5(f) shall mean that [**]. Such significant generic competition shall be measured using [**] of PHARMA, its Affiliates or sublicensees and those of the Third Party or Third Parties, as reported by IMS Health Incorporated (“IMS”) or another reputable, independent market research firm reasonably acceptable to both Parties.
     5.6 Reports; Payment of Royalty. Within thirty (30) days after each Calendar Quarter during the term of this Agreement following the First Commercial Sale of a Product, PHARMA will provide to Genelabs the Sales Report. Genelabs shall submit an invoice to PHARMA

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substantially in the form of Exhibit 5.1 with respect to the royalty amount set forth on such Sales Report. PHARMA shall pay such royalty amount [**] after receipt of such invoice.
     5.7 Audits.
          (a) Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in sufficient detail for the other Party to determine the payments due under this Agreement, including the royalties and FTE funding. Each Party will keep such books and records for at least three (3) years following the end of the fiscal year to which they pertain.
          (b) During the term of this Agreement and for [**] thereafter, each Party (“Auditing Party”) shall have the right to appoint an independent, internationally recognized accounting firm (“Auditor”) to audit the relevant records of the other Party and its Affiliates (and, in the case of PHARMA, its sublicensees) which are authorized to sell Products or required to perform obligations of the Party pursuant to this Agreement (“Audited Party”) to confirm Net Sales, royalties, FTE funding and other payments for a period covering not more than the preceding [**]; provided, however, that the Auditor is reasonably acceptable to the Audited Party and before beginning its audit, executes an undertaking reasonably acceptable to the Audited Party by which the Auditor shall keep confidential all information reviewed during such audit. The Auditor shall have the right to disclose to the Auditing Party only its conclusions regarding the audit and not any of the information reviewed, which conclusions will remain Confidential Information of the Audited Party, subject to Section 4.
          (c) The Audited Party shall make its records (and those of its Affiliates and sublicensees, as applicable) available for inspection by the Auditor during regular business hours at the facility(ies) of the Audited Party where such records are customarily kept, upon reasonable notice from the Auditing Party solely to verify the accuracy of the reports given and payments due under this Agreement. Such audit right may only be exercised once per Calendar Year by the Auditing Party and only once with respect to records covering any specific fiscal year.
          (d) The Auditing Party shall bear the full cost of such audit, unless it discloses an underpayment of royalties or overbooking of FTE funding by the Audited Party of more than [**] of the amount of royalties or FTE funding due or incurred over the audited period, in which case, the Audited Party shall bear the full cost of such audit and shall promptly remit to the Auditing Party the amount of any underpayment of royalties or the amount due because of any overbooking of FTE funding, and PHARMA may credit against any subsequent Royalties due to Genelabs the amount of any overpayment of royalties.
     5.8 Payments and Exchange Rate. Payments to each Party shall be made by electronic wire transfer of immediately available funds to the account of the Party, as designated in writing to the other Party. All payments under this Agreement shall be payable in US dollars. When conversion of payments from any foreign currency is required to be undertaken by PHARMA, such conversion shall be made using PHARMA’s then-current standard exchange rate

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methodology as applied in its external reporting and consistent with PHARMA’s Accounting Standards.
     5.9 Income Tax Withholding. Genelabs will pay any and all taxes levied on account of any payments made to it under this Agreement. If any taxes are required to be withheld by PHARMA, PHARMA will (a) deduct such taxes from the payment made to Genelabs, (b) timely pay the taxes to the proper taxing authority, and (c) send proof of payment to Genelabs and certify its receipt by the taxing authority promptly following such payment.
     5.10 No Projections. Genelabs acknowledges and agrees that nothing in this Agreement shall be construed as representing an estimate or projection of either (a) the number of Collaboration Compounds or Products, if any, that may be successfully developed and/or commercialized or (b) anticipated sales of any Product, and that the milestones and Net Sales levels set forth in Sections 5.3, 5.4, 5.5 and Exhibit 5.3 or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the Milestone Payments and royalty obligations to Genelabs in the event such milestones and/or Net Sales levels are achieved. PHARMA MAKES NO REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP AND/OR COMMERCIALIZE ANY COLLABORATION COMPOUND OR ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF SUCH PRODUCT WILL BE ACHIEVED.
6.   REPRESENTATIONS, WARRANTIES AND COVENANTS
     6.1 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party that, as of the date of this Agreement:
     (a) such Party is duly organized and validly existing under the laws of the state of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
     (b) such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance its obligations under this Agreement;
     (c) this Agreement is a legal and valid obligation of such Party, binding upon such Party and enforceable against such Party in accordance with the terms of this Agreement, except as enforcement may be limited by applicable bankruptcy or other debtor’s rights laws and regulations;
     (d) the execution, delivery and performance of this Agreement by such Party does not (i) violate any agreement or instrument to which such Party is a party or by which such Party is bound, (ii) conflict with or result in a breach of any provision of its organizational documents or (iii) violate any law or regulation of any court,

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governmental body or administrative or other agency having authority over such Party;
     (e) all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and
     (f) it has the full and exclusive right, power and authority to enter into this Agreement, to perform the Research Program and to grant the licenses granted by such Party under Article 3 hereof.
     6.2 Genelabs Representations and Warranties. Genelabs represents and warrants to PHARMA that as of the Effective Date:
     (a) Exhibit 1.B sets forth a complete and accurate list of all Genelabs Patents in existence as of the Effective Date;
     (b) Genelabs is the sole and exclusive owner or exclusive licensee of all of the Genelabs Patents free from Encumbrances and is listed in the records of the appropriate United States and/or foreign governmental agencies as the sole and exclusive owner of record or exclusive licensee for each registration, grant and application included in the Genelabs Patents;
     (c) Genelabs has the right to grant to PHARMA the licenses under the Genelabs Technology that it purports to grant hereunder;
     [**] and
          (n) (i) neither Genelabs nor to the knowledge of Genelabs any employee, agent or subcontractor of Genelabs involved or to be involved in any activities performed hereunder has been (A) convicted of an offense related to any federal or state health care program; (B) excluded from participation as a provider under any Federal or State health care program or (C) debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known to have been debarred under Subsection (a) or (b) of Section 306 of said Act will be employed by Genelabs in the performance of any activities hereunder; and (iii) no Person on any of the following FDA Clinical Investigator enforcement lists, including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List, will participate in the performance of any activities hereunder. Genelabs further certifies that if, at any time after execution of this Agreement, it becomes aware that it or any employee, agent or subcontractor of Genelabs who participated, or is participating, in the performance of any activities hereunder is on, or is being added to the FDA Debarment List or any of the three (3) FDA Clinical Investigator Restriction Lists, it will provide notice of this to PHARMA within two (2) Business Days of its becoming aware of this fact.

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     6.3 Genelabs Covenants.
          (a) Genelabs covenants and agrees that it will not grant any interest in the Collaboration Patents or Collaboration Know-How which is inconsistent with the terms and conditions of this Agreement, nor shall Genelabs assign its right, title or interest in or to the Collaboration Patents to any Third Party or cause or permit any of the Genelabs Technology to be subject to any Encumbrances other than this Agreement or Encumbrances granted to Third Party financial institutions that are not Competitors in connection with a bona fide financing.
          (b) All individuals currently employed or retained by Genelabs who will perform any activities on behalf of Genelabs in connection with the Research Program have assigned to Genelabs the whole of their rights in any intellectual property conceived or reduced to practice by them as a result of the Research Program, and to the knowledge of Genelabs, no Third Party will have any rights to any such intellectual property. Any new individuals employed or retained by Genelabs who will perform any such activities will execute such an assignment.
     6.4 Disclaimer. Except as expressly set forth herein, THE TECHNOLOGY, MATERIALS AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES. Without limiting the generality of the foregoing, each Party expressly does not warrant (a) the success of any study or test commenced under the Research Program or (b) the safety or usefulness for any purpose of the intellectual property or technology it provides hereunder.
7.   INTELLECTUAL PROPERTY RIGHTS
     7.1 Ownership of Joint Inventions.
          (a) All Inventions arising from the Parties’ activities under this Agreement, including Patents and other intellectual property rights covering such Inventions, made solely by employees or consultants of a Party shall be owned by such Party.
          (b) All Joint Inventions shall be owned jointly by the Parties.
          (c) Determination of inventorship shall be made in accordance with United States patent laws.
          (d) Genelabs’ rights in any Joint Inventions made under this Agreement and its interest in any Joint Inventions owned jointly by the Parties shall be included in the Genelabs Technology for the purposes of this Agreement. PHARMA’s rights in any Joint Inventions

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made under this Agreement and its interest in any Joint Inventions owned jointly by the Parties shall be included in the PHARMA Technology for the purposes of this Agreement.
          (e) In the event of any disagreement between the Parties regarding the inventorship or ownership of any Joint Invention, the Parties shall refer such dispute to a neutral Third Party patent attorney or other appropriately qualified person who is neither a current or former employee or director of, nor a current or former consultant or outside counsel to, either Party and who is mutually agreed upon by the Parties.
     7.2 Patent Prosecution.
          (a) The Genelabs Patents in existence as of the Effective Date are listed in Exhibit 1.B hereto. The Parties shall update such Exhibit as appropriate (at least once per Calendar Quarter) to add to Exhibit 1.B each Collaboration Patent filed after the Effective Date.
          (b) Genelabs will be solely responsible, in consultation with PHARMA, for filing, prosecuting and maintaining the Genelabs Patents, at its own expense, with PHARMA having the right to review and comment on strategic decisions and drafts of substantive patent submissions with respect thereto. Genelabs shall comply with, and incorporate in the applicable patent submissions, all PHARMA comments submitted pursuant to the foregoing sentence, unless Genelabs has reasonable objection thereto and discusses such objections with PHARMA. With respect to each Genelabs Patent, Genelabs shall prosecute such Patent in the jurisdictions set forth on Exhibit 7.2 as being Genelabs’ responsibility. Genelabs will keep PHARMA regularly and fully informed of the status of such Genelabs Patents and provide copies of all substantive documentation submitted to, or received from, the patent offices in connection therewith.
          (c) In the event that Genelabs declines to file, prosecute or maintain any Genelabs Patent, it shall give PHARMA reasonable notice of at least [**] to this effect, sufficiently in advance to permit PHARMA to undertake such filing, prosecution and maintenance without a loss of rights, and thereafter PHARMA may, upon written notice to Genelabs, file and prosecute such Genelabs Patents and maintain such Genelabs Patents in Genelabs’ name, all at PHARMA’s expense (subject to the immediately following sentence), and all such Genelabs Patents shall remain owned exclusively by Genelabs, subject to the provisions of Section 3.1. If PHARMA incurs filing, prosecution and/or maintenance expenses with respect to Genelabs Patents owned by Genelabs in accordance with the immediately preceding sentence, PHARMA shall be entitled to deduct [**] from the payments due for [**] payable to Genelabs pursuant to this Agreement, subject to the Agreed Limit. Any portion of such expenses that PHARMA is entitled to deduct in accordance with the foregoing but which PHARMA is unable to deduct in any Calendar Quarter due to application of the Agreed Limit shall be rolled forward and deducted in the next Calendar Quarter for purposes hereof (subject to the Agreed Limit in such next Calendar Quarter) and so on until PHARMA has fully deducted the full amount of such expenses. PHARMA will keep Genelabs regularly and fully informed of the status of such Genelabs Patents and provide copies of all substantive documentation submitted to, or received from, the

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patent offices in connection therewith. Genelabs shall have the right to review and comment on strategic decisions and drafts of substantive patent submissions with respect thereto. PHARMA shall comply with, and incorporate in the applicable patent submissions, all Genelabs comments submitted pursuant to the foregoing sentence, unless PHARMA has reasonable objection thereto and discusses such objections with Genelabs.
          (d) PHARMA may, but is not obligated, to file and prosecute Genelabs Patents and maintain such Genelabs Patents in Genelabs’ name, all at PHARMA’s expense (subject to the immediately following sentence), in the countries listed on Exhibit 7.2 as being PHARMA’s responsibility and in any other countries in its sole discretion, and all such Genelabs Patents shall remain owned exclusively by Genelabs, subject to the provisions of Section 3.1. If PHARMA incurs filing, prosecution and/or maintenance expenses with respect to Genelabs Patents owned by Genelabs in accordance with the immediately preceding sentence, PHARMA shall be entitled to deduct [**] from the payments due for [**] payable to Genelabs pursuant to this Agreement, subject to the Agreed Limit. Any portion of such expenses that PHARMA is entitled to deduct in accordance with the foregoing but which PHARMA is unable to deduct in any Calendar Quarter due to application of the Agreed Limit shall be rolled forward and deducted in the next Calendar Quarter for purposes hereof (subject to the Agreed Limit in such next Calendar Quarter) and so on until PHARMA has fully deducted the full amount of such expenses. PHARMA will keep Genelabs regularly and fully informed of the status of such Genelabs Patents and provide copies of all substantive documentation submitted to, or received from, the patent offices in connection therewith. Genelabs shall have the right to review and comment on strategic decisions and drafts of substantive patent submissions with respect thereto. PHARMA shall comply with, and incorporate in the applicable patent submissions, all Genelabs comments submitted pursuant to the foregoing sentence, unless PHARMA has reasonable objection thereto and discusses such objections with Genelabs. In the event that PHARMA declines to file, prosecute or maintain any Genelabs Patent, it shall give Genelabs reasonable notice of at least [**] to this effect, sufficiently in advance to permit Genelabs to undertake such filing, prosecution and maintenance without a loss of rights, and cooperate in transferring prosecution rights and applicable patent files to Genelabs. Such Patents transferred to Genelabs shall remain subject to the provisions of Section 3.1.
          (e) PHARMA will be solely responsible for filing, prosecuting and maintaining the PHARMA Patents at its own expense.
          (f) PHARMA will be responsible for filing, prosecuting and maintaining Joint Patents, with Genelabs having the right to review and comment on drafts of substantive patent submissions with respect thereto. PHARMA will keep Genelabs regularly and fully informed of the status of such Joint Patents and provide copies of all substantive documentation submitted to, or received from, the patent offices in connection therewith. Genelabs will assist PHARMA in connection with the prosecution and maintenance of such Joint Patents, including by providing access to relevant Persons and executing and producing all required documentation.

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          (g) PHARMA shall give timely notice to Genelabs of any decision not to file applications for, or to cease prosecution and/or maintenance of any Joint Patent, or not to continue to pay the expenses of prosecution and/or maintenance of any Joint Patent, on a country-by-country basis and shall permit Genelabs, at its sole discretion and expense, to file or to continue prosecution or maintenance of such Joint Patent. PHARMA will provide such notice at least [**] prior to any filing or payment due date, or any other due date that requires action, in connection with such Patent.
          (h) The Parties agree that Joint Patents shall be exclusively licensed to PHARMA in accordance with the terms of this Agreement.
     7.3 Patent Infringement.
          (a) Each Party will promptly notify the other of any infringement by a Third Party of any Collaboration Patent or Joint Patent of which it becomes aware, including any “patent certification” filed by a Third Party FDA application which references the foregoing (collectively “Third Party Infringement”). The Parties will consult with each other through the Committee to determine the response to any Third Party Infringement.
          (b) PHARMA will have the first right to take any action in connection with the Third Party Infringement as it reasonably determines appropriate, and Genelabs shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
          (c) If PHARMA fails to bring an action or proceeding with respect to, or to terminate, Third Party Infringement of any such Collaboration Patent or Joint Patent (i) within [**] days following Genelabs’ notice of alleged infringement pursuant to Section 7.3(a) or (ii) prior to [**] days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, Genelabs shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and PHARMA shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if PHARMA notifies Genelabs in writing prior to [**] days before such time limit for the filing of any such action that PHARMA intends to file such action before the time limit, then PHARMA shall be obligated to file such action before the time limit, and Genelabs will not have the right to bring and control such action.
          (d) In no event shall either Party, through any court action or proceeding, any settlement arrangement or any proceeding, filing or communication with any patent office, admit the invalidity of, or otherwise impair the other Party’s rights in, any Collaboration Patent, or Joint Patent, without the other Party’s prior written consent.
          (e) At the request and expense of the Party controlling a Third Party Infringement action, the other Party shall provide reasonable assistance in connection therewith, including by executing and producing any required documents and joining as a party to the action if required.

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     7.4 Defense of Actions. In the event that a declaratory judgment or similar action alleging the invalidity or non-infringement of any of the Collaboration Patents or Joint Patents is initiated by any Third Party, each Party will promptly notify the other. The Parties will consult with each other to determine the response to such claim. If the Parties fail to agree on a joint program of action, PHARMA shall have the right to defend and control such action and, at PHARMA’s request and expense, Genelabs shall provide reasonable assistance to PHARMA in connection therewith, including by executing and producing any required documents and joining as a party to the action if required. PHARMA shall give Genelabs timely notice of any proposed settlement of any such proceeding relating to a Collaboration Patent or Joint Patent and shall not enter into such settlement admitting the invalidity of, or otherwise impairing Genelabs’ rights in, such Patents without the prior written consent of Genelabs. If PHARMA fails to defend and control such action with respect to any such Collaboration Patent or Joint Patent prior to [**] days before the time limit, if any, set forth in the appropriate laws and regulations for response to such action, Genelabs shall have the right to defend and control such action at its own expense and by counsel of its own choice, and, at Genelabs’ request and expense, PHARMA shall provide reasonable assistance to Genelabs in connection therewith, including by executing and producing any required documents and joining as a party to the action if required. Genelabs shall give PHARMA timely notice of any proposed settlement of any such proceeding relating to a Collaboration Patent or Joint Patent and shall not enter into such settlement admitting the invalidity of, or otherwise impairing PHARMA’s rights in, such Patents without the prior written consent of PHARMA.
     7.5 Recoveries. Any recovery obtained as a result of any proceeding described in Section 7.3 or from any counterclaim or similar claim asserted in a proceeding described in Section 7.4, by settlement or otherwise, shall be applied in the following order of priority:
      (i) first, the Party initiating the suit, action or claim shall be reimbursed for all costs in connection with such proceeding paid by such Party;
      (ii) second, the other Party shall be reimbursed for all costs in connection with such proceeding paid by the other Party; and
      (iii) third, any remainder shall be [**].
     7.6 Drug Price Competition and Patent Term Restoration Act.
          (a) The Parties agree to cooperate in an effort to avoid loss of any Patents which may otherwise be available to the Parties hereto under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the United States, including by executing and producing any documents as may be reasonably required. In particular, the Parties shall cooperate with each other in obtaining patent term restoration or supplemental protection certificates or their equivalents in any country and region where applicable to the Collaboration Patents or Joint Product Patents. Genelabs shall provide all

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reasonable assistance to PHARMA, including permitting PHARMA to proceed with applications for such in the name of Genelabs, if so required.
          (b) The Parties shall cooperate in determining which Collaboration Patents or Joint Patents, if any, the Parties will attempt to extend, which determination shall be made in good faith by PHARMA. Genelabs shall provide reasonable assistance to PHARMA, including by executing and producing any required documents and providing any relevant patent information to PHARMA, so that PHARMA, as NDA applicant, may inform the FDA or other Regulatory Authority.
8.   LIMITATION OF LIABILITY
     IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, including, but not limited to, loss of profits or revenue, except for liability to the extent any such damages are required to be paid to a Third Party as part of a Third Party Claim pursuant to Article 10.
9.   TERM AND TERMINATION
     9.1 Term and Expiration. This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Section 9.2 or 9.3, this Agreement shall continue in effect until expiration of the last-to-expire Royalty Term hereunder.
     9.2 Termination by PHARMA. Notwithstanding anything contained in this Agreement to the contrary, PHARMA shall have the right to terminate this Agreement at any time in its sole discretion and for any reason after the end of the Research Program Term by giving sixty (60) days advance written notice to Genelabs. In the event of termination under this Section 9.2:
     (a) At the option of Genelabs exercisable by written notice to PHARMA within ninety (90) days following termination, PHARMA and Genelabs shall negotiate the terms for an arrangement where [**]; and
     (b) except as set forth in this Section 9.2 and in Section 9.4, the rights and obligations of the Parties hereunder shall terminate as of the date of such early termination.
     9.3 Termination for Cause.
          9.3.1 Cause for Termination. This Agreement may be terminated at any time during the term of this Agreement:
          (a) upon written notice by a Party if the other Party is in material breach of its obligations hereunder by causes and reasons within its control and has not cured such

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[ * *] = 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.
breach within ninety (90) days after written notice specifying the claimed particulars of such breach and requesting cure of the breach; provided, however, that if such breach is capable of being cured, but cannot be cured within such ninety (90) day period, and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have such additional period as is reasonable in the circumstances to cure such breach; or
          (b) by a Party upon the Bankruptcy of the other Party.
          9.3.2 Effect of Termination for Cause.
          (a) Termination by PHARMA. If PHARMA terminates this Agreement under Section 9.3.1(a) or 9.3.1(b):
               (i) the licenses granted under Section 3.1(b) shall immediately terminate;
               (ii) the licenses granted under Section 3.1(a) and the provisions of Sections 3.6 and 3.7 and Sections 5.3 — 5.10 shall survive, except that [**];
               (iii) PHARMA shall have the right in its discretion to assume responsibility for the prosecution and/or maintenance of all Genelabs Patents, the provisions of Section 7.2(d) shall apply thereto with respect to all countries (and not only with respect to countries which were PHARMA’s responsibility pursuant to said Section prior to the termination of this Agreement) and Genelabs shall cooperate in transferring to PHARMA such prosecution and/or maintenance rights assumed by PHARMA;
               (iv) if PHARMA believes it has suffered monetary damages as a result of Genelabs’ breach, PHARMA shall have the right to make a claim against Genelabs for such damages; and
               (v) except as set forth in this Section 9.3.2(a) and in Section 9.4, the rights and obligations of the Parties hereunder shall terminate as of the date of such termination.
          (b) Termination by Genelabs. If Genelabs terminates this Agreement under Section 9.3.1(a) or 9.3.1(b):
                     (i) if Genelabs believes it has suffered monetary damages as a result of PHARMA’s breach, Genelabs shall have the right to make a claim against PHARMA for such damages;
                     (ii) PHARMA shall provide Genelabs with copies of its patent files for Genelabs Patents being prosecuted or maintained by it under Sections 7.2(c) or (d) and shall

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[ * *] = 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.
cooperate in transferring prosecution rights to Genelabs, and the provisions of Section 9.2(a) shall apply; and
                     (iii) except as set forth in this Section 9.3.2(b) and in Section 9.4, the rights and obligations of the Parties hereunder shall terminate as of the date of such termination.
     9.4 Effect of Expiration or Termination; Survival.
          (a) Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including without limitation the obligation to pay royalties in accordance with this Agreement for Product(s) sold prior to such expiration termination. Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available except as agreed to otherwise herein.
          (b) The provisions of Article 4 shall survive the expiration or termination of this Agreement and shall continue in effect for [**]. In addition, the provisions of the following Articles and Sections shall survive expiration or termination of this Agreement.
     
Article 1
  (Definitions)
Section 2.10(b)
  (relating to return of Materials)
Section 2.7.1 and 2.7.2
  (Records and Reports)
Section 5.8
  (Payments and Exchange Rate)
Section 5.9
  (Income Tax Withholding)
Section 5.10
  (No Projections)
Section 6.4
  (Disclaimer)
Article 7
  (Intellectual Property) (but only with respect to Joint Inventions)
Article 8
  (Limitation of Liability)
Article 9
  (Term and Termination)
Article 10
  (Indemnification)
Article 11
  (Miscellaneous)
     9.5 Rights in Bankruptcy.
          (a) All rights and licenses granted under or pursuant to this Agreement are, and will otherwise be deemed to be, for purposes of Section 365(n) of the US Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as defined under Section 101 of the Code. The Parties agree that PHARMA, as licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Genelabs under the Code, PHARMA will be entitled to a complete duplicate of (or complete access to, as

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[ * *] = 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.
appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in its possession, will be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless Genelabs elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, following the rejection of this Agreement by or on behalf of Genelabs upon written request therefor by PHARMA.
          (b) All rights, powers and remedies of PHARMA provided for in this Section 9.5 are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, under the Code). In the event of the Bankruptcy of Genelabs, PHARMA, in addition to the rights, power and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including, without limitation, under the Code). The Parties agree that they intend the following PHARMA rights to extend to the maximum extent permitted by law, including, without limitation, for purposes of the Code: (i) the right of access to any intellectual property (including all embodiments thereof) of Genelabs, or any Third Party with whom Genelabs contracts to perform an obligation of Genelabs under this Agreement which is necessary for the development, registration, manufacture and/or marketing of Collaboration Compounds and/or Products in the Field in the Territory; (ii) the right to contract directly with any Third Party described in (i) to complete the contracted work, and (iii) the right to cure any breach of or default under any such agreement with a Third Party and set off the costs thereof against amounts payable to Genelabs under this Agreement.
10.   INDEMNIFICATION
     10.1 Indemnification by PHARMA. PHARMA hereby agrees to indemnify, defend and hold Genelabs and its Affiliates, and their respective directors, officers, employees, contractors, agents and assigns (each, a “Genelabs Indemnitee”) harmless from and against any and all Third Party claims, suits, actions, demands, liabilities, investigations, proceedings, expenses and/or losses, including reasonable legal costs and attorneys’ fees (collectively, “Losses”), to which any Genelabs Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Person other than a Party or its Affiliates to the extent such Losses arise or result directly or indirectly out of: (i) the breach by PHARMA of any warranty, representation, covenant or agreement made by PHARMA in this Agreement, (ii) the actions of PHARMA or its Affiliates in connection with the research, development or commercialization of Collaboration Compounds or Products under this Agreement, or (iii) the negligence or willful or criminal misconduct of PHARMA or its Affiliates; except, in each case, to the extent such Losses result from the negligence or willful misconduct of any Genelabs Indemnitee or the breach by Genelabs of any warranty, representation, covenant or agreement made by Genelabs in this Agreement.
     10.2 Indemnification by Genelabs. Genelabs hereby agrees to indemnify, defend and hold PHARMA and its Affiliates and their respective directors, officers, employees, contractors,

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[ * *] = 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.
agents and assigns (each, a “PHARMA Indemnitee”) harmless from and against any and all Losses to which any PHARMA Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Person other than a Party or its Affiliates to the extent such Losses arise directly or indirectly out of: (i) the breach by Genelabs of any warranty, representation, covenant or agreement made by Genelabs in this Agreement, (ii) the actions of Genelabs or its Affiliates in connection with the research or development of Collaboration Compounds and/or Products under this Agreement or (iii) the negligence or willful or criminal misconduct of Genelabs or its Affiliates; except, in each case, to the extent such Losses result from the negligence or willful misconduct of any PHARMA Indemnitee or the breach by PHARMA of any warranty, representation, covenant or agreement made by PHARMA in this Agreement.
     10.3 Control of Defense.
          (a) Any Party or any of its Affiliates seeking indemnification hereunder (the “indemnified party”) shall notify the other Party (the “indemnifying party”) in writing reasonably promptly after the assertion against the indemnified party of any claim or allegation by a Third Party (a “Third Party Claim”) in respect of which the indemnified party intends to base a claim for indemnification hereunder, but the failure or delay so to notify the indemnifying party shall not relieve the indemnifying party of any obligation or liability that it may have to the indemnified party except to the extent that the indemnifying party demonstrates that its ability to defend or resolve such Third Party Claim is adversely affected thereby.
          (b) (i) Subject to the provisions of Section 10.3(d) below, the indemnifying party shall have the right, upon written notice given to the indemnified party within thirty (30) days after receipt of the notice from the indemnified party of any Third Party Claim to assume the defense or handling of such Third Party Claim, at the indemnifying party’s sole expense, in which case the provisions of Section 10.3(b)(ii) below shall govern.
               (ii) The indemnifying party shall select counsel reasonably acceptable to the indemnified party in connection with conducting the defense or handling of such Third Party Claim, and the indemnifying party shall defend or handle the same in consultation with the indemnified party, and shall keep the indemnified party timely apprised of the status of such Third Party Claim. The indemnifying party shall not, without the prior written consent of the indemnified party, agree to a settlement of any Third Party Claim which could lead to liability or create any financial or other obligation on the part of the indemnified party for which the indemnified party is not entitled to indemnification hereunder. The indemnified party shall cooperate with the indemnifying party and shall be entitled to participate in the defense or handling of such Third Party Claim with its own counsel and at its own expense. Notwithstanding the foregoing, in the event the indemnifying party fails to conduct the defense or handling of any Third Party Claim in good faith after having assumed such defense or handling, then the provisions of Section 10.3(c)(ii) below shall govern.

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[ * *] = 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.
          (c) (i) If the indemnifying party does not give written notice to the indemnified party, within thirty (30) days after receipt of the notice from the indemnified party of any Third Party Claim, of the indemnifying party’s election to assume the defense or handling of such Third Party Claim, the provisions of Section 10.3(c)(ii) below shall govern.
               (ii) The indemnified party may, at the indemnifying party’s expense, select counsel in connection with conducting the defense or handling of such Third Party Claim and defend or handle such Third Party Claim in such manner as it may deem appropriate, provided, however, that the indemnified party shall keep the indemnifying party timely apprised of the status of such Third Party Claim and shall not settle such Third Party Claim without the prior written consent of the indemnifying party, which consent shall not be unreasonably withheld. If the indemnified party defends or handles such Third Party Claim, the indemnifying party shall cooperate with the indemnified party and shall be entitled to participate in the defense or handling of such Third Party Claim with its own counsel and at its own expense.
          (d) If the indemnified party intends to seek indemnification hereunder, other than for a Third Party Claim, then it shall notify the indemnifying party in writing promptly after its discovery of facts upon which it intends to base its claim for indemnification hereunder, but the failure or delay so to notify the indemnifying party shall not relieve the indemnifying party of any obligation or liability that it may have to the indemnified party except to the extent that the indemnifying party demonstrates that the indemnifying party’s ability to defend or resolve such claim is adversely affected thereby.
     10.4 Insurance. Each Party, at its own expense, shall maintain product liability insurance (or self-insure) in an amount consistent with industry standards during the term of this Agreement.
11.   MISCELLANEOUS
     11.1 Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, earthquakes, tsunamis or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance.

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[ * *] = 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.
     11.2 Assignment and Change of Control.
          11.2.1 Except as provided in this Section 11.2, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the written consent of the other Party.
          11.2.2 Either Party shall be entitled to assign the benefit and/or burden of this Agreement to any Affiliate or to its successor in connection with any merger, consolidation or sale or other disposal of all or substantially all of its assets and/or business to which this Agreement relates.
          11.2.3 Genelabs Change of Control. Upon a Change of Control of Genelabs involving a Competitor, Genelabs shall provide written notice to PHARMA and PHARMA shall have the right in its sole discretion, at its election at any time within [**] after such notice, to either:
               (a) terminate the Research Program (and thereby the Research Program Term) upon written notice to Genelabs or its successor. Upon such termination, all other provisions of this Agreement applicable to the period following the Research Program Term shall continue in force; or
               (b) terminate this Agreement upon written notice to Genelabs or its successor. Upon such termination, the provisions of Section 9.2 shall apply.
          11.2.4 Any attempted assignment not in accordance with this Section 11.2 shall be void. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement.
     11.3 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
     11.4 Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

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[ * *] = 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.
If to Genelabs,
     
to:
  Genelabs Technologies, Inc.
 
  505 Penobscot Drive
 
  Redwood City, CA 94063
 
  Attention: Chief Executive Officer
 
  Facsimile No.: [**]
 
   
and:
  Genelabs Technologies, Inc.
 
  505 Penobscot Drive
 
  Redwood City, CA 94063
 
  Attention: General Counsel
 
  Facsimile No.: [**]
 
   
if to PHARMA,
   
 
   
to:
  Novartis Institutes for BioMedical Research, Inc.
 
  400 Technology Square
 
  Cambridge, Massachusetts 02139
 
  Attention: General Counsel
 
  Facsimile No.: [**]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; and/or (c) on the fifth Business Day following the date of mailing if sent by mail.
     11.5 Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws thereof.
     11.6 Jurisdiction. Any disputes between the Parties relating to this Agreement shall be subject to the exclusive jurisdiction and venue of the federal courts located in the Southern District of New York (without restricting any right of appeal), and the Parties hereby waive any objection which they may have now or hereafter to the laying of venue of any proceedings in such courts and to any claim that such proceedings have been brought in an inconvenient forum, and further agree that a judgment or order in any such proceedings shall be binding upon each of them and may be enforced in the courts of any other jurisdiction.
     11.7 Entire Agreement; Amendments. This Agreement, together with the exhibits hereto, contains the entire understanding of the Parties with respect to the subject matter hereof and supercedes and cancels all previous express or implied agreements and understandings,

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[ * *] = 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.
negotiations, writings and commitments, either oral or written, with respect to the subject matter hereof. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
          The Parties acknowledge and agree that, as of the Effective Date, all confidential information disclosed pursuant to the Confidentiality Agreements by a Party or its Affiliates (including confidential information disclosed by Genelabs to individual employees of PHARMA or its Affiliates who were signatories to any of the Confidentiality Agreements) shall be included in the Confidential Information subject to this Agreement and the Confidentiality Agreements shall terminate and have no further force or effect as between the Parties; provided, that (i) the foregoing shall not relieve any Person of any right or obligation accruing under the Confidentiality Agreements prior to the Effective Date, (ii) any Person which is not a Party or an Affiliate of a Party and which is a signatory to any of the Confidentiality Agreements (other than any employee of PHARMA or an Affiliate of a Party, who are now subject to the obligations of Section 4 of this Agreement) shall remain bound by its obligations under the Confidentiality Agreements in accordance with the terms thereof, (iii) all provisions of the Letter Agreement that do not deal with confidentiality and use of information, except the third full paragraph on page four thereof dealing with [**], shall survive this Agreement and (iv) notwithstanding clause (iii) above, nothing in the Letter Agreement shall be construed to preclude PHARMA or its Affiliates from participating in any [**]. Any employee of PHARMA or its Affiliates who is a signatory to any of the Confidentiality Agreements shall be a Third Party beneficiary of the previous sentence.
     11.8 Headings. The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.
     11.9 Independent Contractors. It is expressly agreed that Genelabs and PHARMA shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Genelabs nor PHARMA shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.
     11.10 Waiver. The waiver by either Party hereto of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.
     11.11 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

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[ * *] = 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.
     11.12 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
     11.13 Trademark Rights. No right, express or implied, is granted by this Agreement to a Party to use in any manner the name or any other trade name or trademark of a Party in connection with the performance of this Agreement. PHARMA shall have the right to brand the Products using PHARMA related trademarks and trade names and any other trademarks and trade names it determines appropriate for the Product, which may vary by country or within a country (“Product Marks”); provided that nothing herein shall be deemed a license to PHARMA of any Genelabs trade name or trademark. PHARMA shall own all rights in the Product Marks and register and maintain the Product Marks in the countries and regions it determines reasonably necessary.
     11.14 Compliance with Law. Nothing in this Agreement shall be deemed to permit a Party to export, re-export or otherwise transfer any Product sold under this Agreement without compliance with applicable laws.
     11.15 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
     11.16 No Third Party Beneficiaries. Subject to Section 11.7, this Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including, without limitation, any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby.
     11.17 Extension to Affiliates. Each Party shall have the right to extend the rights and immunities granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement, except this right to extend, shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to the Party extending such rights and immunities. The Party extending the rights and immunities granted hereunder shall remain primarily liable for any acts or omissions of its Affiliates.
     11.18 Further Assurances. PHARMA and Genelabs hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement.
Signature Page to Follow

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[ * *] = 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.
     IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date set forth above.
                 
NOVARTIS INSTITUTES FOR BIOMEDICAL
RESEARCH, INC.
      GENELABS TECHNOLOGIES, INC.
 
               
BY:
          BY:    
 
               
 
               
NAME:
  Jeremy Levin       NAME:   James A.D. Smith
 
               
TITLE:
  Global Head Strategic Alliances       TITLE:   President and Chief Executive Officer

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[ * *] = 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.
List of Exhibits
1.A   Genelabs Compounds
 
1.B   List of Genelabs Patents
 
1.C   Definition of Related Compounds
 
1.D   Research Plan
 
2.5.2   [**]
 
4.4   Press Release
 
5.1   Form of Invoice
 
5.3   Milestone Payments
 
6.2(h)   Exceptions
 
7.2   Patent Application Jurisdictions

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[ * *] = 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.
Exhibit 1.A
Genelabs Compounds
[**]

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[ * *] = 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.
Exhibit 1.B
List of Collaboration Patents
GENELABS PATENTS
(as of June 2, 2006)
[**]

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[ * *] = 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.
PHARMA PATENTS
(as of June 2, 2006)
[**]

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[ * *] = 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.
Exhibit 1.C
Related Compounds
[**]
Exhibit 1.D
Research Plan
[**]

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[ * *] = 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.
Exhibit 2.5.2
[**]

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[ * *] = 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.
Exhibit 4.4
Press Release
GENELABS ANNOUNCES COLLABORATION
FOR DEVELOPMENT AND COMMERCIALIZATION
OF HCV NON-NUCLEOSIDE DRUG CANDIDATES
REDWOOD CITY, Calif. – June 5, 2006 – Genelabs Technologies, Inc. (Nasdaq:GNLB) announced today that it has entered into a license and collaboration agreement with Novartis for the development and commercialization of compounds from Genelabs’ Hepatitis C Virus (HCV) non-nucleoside drug discovery program.
“I am delighted that Genelabs and Novartis are entering into this collaboration. This collaboration links us with a partner that has the scope, scale, expertise and commitment to make a major impact on the future treatment of HCV infection,” stated James A.D. Smith, President and Chief Executive Officer. “The Genelabs non-nucleosides covered by this collaboration have the potential to be complementary with other HCV drugs being developed by Novartis, and I believe Novartis is well positioned to move this project forward efficiently.”
Under the terms of the agreement, Genelabs is eligible to receive approximately $20 million over a planned two-year research program, including initial up-front payments of $12.5 million. If all potential clinical, regulatory and sales milestones are met, additional payments to Genelabs could exceed $175 million. Genelabs is also entitled to a royalty on net sales of products covered by the collaboration.
“This is the second major collaboration for Genelabs based on our HCV drug discovery platform, and we are very pleased to have Novartis as our partner,” stated Ronald C. Griffith, Ph.D., Chief Scientific Officer. “I am proud of the highly skilled and dedicated scientists working at Genelabs, who have all contributed to our HCV drug discovery successes.”
About the Hepatitis C Virus
Hepatitis C is a viral liver disease caused by infection with the Hepatitis C Virus. Worldwide, 170 million people are estimated to be infected with the hepatitis C virus. Liver disease resulting from chronic HCV infection is now recognized as the leading cause of liver failure and liver transplantation in the United States. Currently, there is no vaccine that can protect against HCV infection.
About the collaboration
Under the terms of the agreement, Genelabs is responsible for drug discovery research and Novartis is responsible for development and commercialization. Novartis has an option to extend the research funding for a third year and has a right of first negotiation for Genelabs’ HCV NS5a drug discovery compounds.

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[ * *] = 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.
Lazard acted as financial advisor to Genelabs.
About Genelabs Technologies
Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery capabilities that can support various research and development projects. Genelabs is currently concentrating these capabilities on discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program, while also developing a late-stage product for lupus. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.
Note: Genelabs® and the Genelabs logo are registered trademarks and Prestara™ is a trademark of Genelabs Technologies, Inc.
NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains forward-looking statements including statements regarding the progress of the Company’s HCV drug discovery programs, including the preclinical development status and future development of compounds that may result from the collaboration with Novartis. It also contains forward-looking statements regarding Genelabs’ NS5a program, the Company’s business strategy, and payments that may be received under the collaboration with Novartis. These forward-looking statements are based on Genelabs’ current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, the potential delisting of Genelabs common stock from the Nasdaq Capital Market; fluctuations in Genelabs’ stock price; failures or setbacks in our HCV research and development programs or in our collaboration with Gilead; progress and announcements by competitors regarding their HCV programs; regulatory problems or delays regarding Prestara™, including an adverse response from the FDA or a determination to discontinue development of Prestara; lease termination; increases in expenses and Genelabs’ capital requirements and history of operating losses. Please see the information appearing in Genelabs’ filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions “Risk Factors” and “Forward-Looking Statements” for more discussion regarding these uncertainties and risks and others associated with the company’s research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.

57


 

[ * *] = 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.
Exhibit 5.1
         
 
  contact person   company name
 
  position   address
 
       
 
      Tel
 
      Fax
COMPANY LOGO
      E-mail: xxxx
INVOICE                              
Novartis Institute for Biomedical Research, Inc.
[**]   [**]    
Date
FTE/Milestone payment debit for the period of (time frame) in reference to our Collaboration Agreement between (partner name) and Novartis Institute for Biomedical Research effective as of (date)
Detailed description of FTE calculation (No. of FTE, rate per FTE applied according to the contract)
Detailed description of Milestone and achievement with reference made to the article in the contract.
Total Payable                                                                          (currency)
xxxxxxx
Payment terms
Bank Wire information:
         
 
  Bank Name:   XX
 
  Account No.:   XX
 
  ABA#:   XX (only applicable in the US)
 
  IBAN:   XX (only applicable in Europe)
 
  SWIFT CODE:   XX (applicable US and Europe)

58


 

[ * *] = 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.
Exhibit 5.3
Milestones
[**]
CONFIDENTIAL

59


 

[ * *] = 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.
Exhibit 6.2(h)
Exceptions
[**]

60


 

[ * *] = 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.
Exhibit 7.2
Patent Application Jurisdictions
Genelabs’ Countries
[**]
PHARMA’s Countries
[**]

61

EX-31.1 3 f22362exv31w1.htm EXHIBIT 31.1 exv31w1
 

Exhibit 31.1
CERTIFICATION
     I, James A.D. Smith, certify that:
          1. I have reviewed this quarterly report on Form 10-Q of Genelabs Technologies, Inc.;
          2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
          3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
          4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
          a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
          b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
          c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
          5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
          a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
          b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
         
     
Date: August 3, 2006  /s/ James A.D. Smith
 
 
  James A.D. Smith   
  President and Chief Executive Officer   

 

EX-31.2 4 f22362exv31w2.htm EXHIBIT 31.2 exv31w2
 

         
Exhibit 31.2
CERTIFICATION
     I, Matthew M. Loar, certify that:
          1. I have reviewed this quarterly report on Form 10-Q of Genelabs Technologies, Inc.;
          2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
          3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
          4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
          a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
          b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
          c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
          5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
          a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
          b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
         
     
Date: August 3, 2006  /s/ Matthew M. Loar
 
 
  Matthew M. Loar   
  Chief Financial Officer   

 

EX-32.1 5 f22362exv32w1.htm EXHIBIT 32.1 exv32w1
 

         
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
AND CHIEF FINANCIAL OFFICER PURSUANT
TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
     Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C § 1350, as adopted), James A.D. Smith, President and Chief Executive Officer of Genelabs Technologies, Inc. (the “Company”), and Matthew M. Loar, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
     1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2006, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
     2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and results of operations of the Company for the period covered by the Periodic Report.
Dated: August 3, 2006
         
/s/ James A.D. Smith
  /s/ Matthew M. Loar    
 
James A.D. Smith
 
 
Matthew M. Loar
   
President and Chief Executive Officer
  Chief Financial Officer    

 

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