EX-10.39 3 a2086245zex-10_39.htm EXHIBIT 10.39
QuickLinks -- Click here to rapidly navigate through this document


EXHIBIT 10.39


LICENSING AGREEMENT

BY AND BETWEEN

GILEAD WORLD MARKETS, LIMITED

AND

GLAXO GROUP LIMITED

April 26, 2002


[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


Table of Contents

 
    
    
   Page
ARTICLE 1   DEFINITIONS   1
  1.1   "Administrative Protection"   1
  1.2   "ADV"   2
  1.3   "Affiliate"   2
  1.4   "Certificate of Pharmaceutical Product"   2
  1.4   "China"   2
  1.5   "Class I Certification"   2
  1.6   "Class II Certification"   2
  1.7   "Clinical Development Committee"   2
  1.9   "Clinical Supply Agreement"   2
  1.8   "Commercial Launch"   2
  1.9   "Commercialization Plan"   2
  1.12   "Commercial Supply Agreement"   3
  1.10   "Commercialize"   3
  1.11   "Committee"   3
  1.12   "Confidential Information"   3
  1.13   "Contract Revenue Term"   3
  1.14   "Control"   3
  1.15   "CPMP"   3
  1.17   "Current Gilead Trials"   3
  1.18   "Current INDs"   4
  1.16   "Current Pediatric Product"   4
  1.19   "Current Product"   4
  1.20   "Diligent Efforts"   4
  1.21   "Distributor"   4
  1.22   "Dollar"   4
  1.26   [ * ]   4
  1.27   [ * ]   4
  1.25   "EMEA"   4
  1.29   "Exclusivity"   4
  1.26   "FDA"   5
  1.31   "Full Exclusivity"   5
  1.28   "Gilead Know-How"   5
  1.29   "Gilead Marks"   5
  1.31   "Gilead Patent"   5
  1.30   "Gilead Product Marks"   5
  1.32   "Gilead Technology"   5
  1.33   "Gilead Territory"   5
  1.34   "GSK Development Plan"   5
  1.35   "GSK Know-How"   5
  1.37   "GSK Patent"   5
  1.36   "GSK Product Marks"   6
  1.38   "GSK Technology"   6
  1.39   "GSK Territory"   6
  1.40   "HBV"   6
  1.41   "HBV Indication"   6
  1.46   "Higher Rate"   6

i

  1.42   "IND"   6
  1.43   "Infringement"   6
  1.44   "IOCB/Rega License"   6
  1.45   "Joint Committee"   6
  1.46   "Joint Invention"   6
  1.47   "Joint Patent"   6
  1.53   "Key Gilead Personnel"   6
  1.48   "Know-How"   6
  1.49   "Licensed Indication"   7
  1.50   "Licensed Product"   7
  1.57   "Limit"   7
  1.51   "Loss"   7
  1.59   "Lower Rate"   7
  1.52   "Major GSK Country"   7
  1.53   "Marketing Authorization Application"   7
  1.54   "Marketing Committee"   7
  1.55   "NDA"   7
  1.56   "Net Sales"   7
  1.65   "Non-Exclusivity"   8
  1.57   "Other Clinical Trial Agreements"   8
  1.58   "Other Formulation"   8
  1.59   "Other Indication"   8
  1.60   "Other Licensee"   8
  1.61   "Other Sales"   8
  1.62   "Patent"   8
  1.63   "Permitted Sublicensee"   9
  1.64   "Phase III Clinical Trial"   9
  1.65   "Phase IIIB Clinical Trial"   9
  1.66   "Phase IV Clinical Trial"   9
  1.67   "Price Approval"   9
  1.68   "Product Labeling"   9
  1.69   "Promotional Materials"   9
  1.70   "Regulatory Approval"   9
  1.71   "Regulatory Authority"   9
  1.72   "Royalty Term"   10
  1.82   "Semi-Exclusivity"   10
  1.73   "Substitutable"   10
  1.84   "Substitutable ADV Product"   10
  1.75   "Term"   11
  1.76   "Territory"   11
  1.77   "Third Party"   11
  1.78   "Third Party Royalties"   11
  1.79   "Valid Claim"   11
ARTICLE 2   MANAGEMENT   11
  2.1   General   11
  2.2   Joint Committee   11
    (a)   Formation   11
    (b)   Specific Responsibilities   12

ii

  2.3   Clinical Development Committee   12
    (a)   Formation   12
    (b)   Specific Responsibilities of the Clinical Development Committee   12
  2.4   Marketing Committee   13
    (a)   Formation   13
    (b)   Specific Responsibilities of the Marketing Committee   13
  2.5   General Committee Membership, Authority and Procedures   14
    (a)   Membership   14
    (b)   Meetings   14
    (c)   Limited Authority   15
    (d)   Decision-Making   15
    (e)   Meeting Agendas   15
    (f)   Information Sharing Between Committees   15
  2.6   Project Coordinators   15
  2.7   Collaboration Guidelines   16
    (a)   General   16
    (b)   Independence   16
    (c)   [ * ]   16
ARTICLE 3   DEVELOPMENT   17
  3.1   Current Status; Overview   17
  3.2   Gilead Development   18
  3.3   GSK Development and Plan   18
    (a)   Responsibility   18
    (b)   Initial Plan   18
    (c)   Updates   18
    (d)   Compassionate Use/Expanded Access Program   20
  3.4   GSK Activities   20
  3.5   Gilead Development of Other Formulations and Other Indications   20
    (a)   General   20
    (b)   Notices and Information Regarding Other Formulations and Other Indications   20
    (c)   Negotiation   21
    (d)   [ * ] with Respect to Substitutable Formulations of ADV   21
    (e)   Gilead Activities with Respect to Different Chemical Entities   22
  3.6   GSK Development of Other Formulations and Indications   23
  3.7   Specific Responsibilities of the Clinical Development Committee during Development   23
  3.8   Site of Activities   23
ARTICLE 4   REGULATORY   24
  4.1   Current Status   24
  4.2   Certificate of Pharmaceutical Products; GSK Marketing Authorization Applications and Regulatory Approvals   24
  4.3   GSK Access to Gilead Know-How   25
    (a)   Regulatory Data   25
    (b)   Form of Transfer; Items not Transferred   26
    (c)   Other Licensee Permission and Know-How   27
    (d)   GSK Use of Know-How   27
    (e)   Gilead Regulatory Filings   27
    (f)   Costs   27

iii

  4.4   Gilead Access to GSK Know-How and Filings   27
    (a)   Provision to Gilead   27
    (b)   Sublicensee Permission; Transferability to Sublicensees   28
  4.5   Adverse Event Reporting   28
  4.6   Communications   28
  4.7   Applications for Regulatory Exclusivity   28
  4.8   Recalls and Voluntary Withdrawals   29
  4.10   Impermitted Regulatory Filings   30
  4.11   No Harmful Actions   30
  4.11   Additional Information and Uses of Information   30
  4.12   Gilead Transition Assistance   31
    (a)   Initial   31
    (b)   Extended   31
    (c)   Additional   31
    (e)   [ * ]   33
    (f)   Mechanics   34
  5.1   Commercialization   34
  5.2   Commercialization Plan   34
  5.3   Promotional Materials   36
  5.4   Training of Sales Force   37
  5.5   Compliance   37
  5.6   Product Trademarks   37
  5.7   No Misappropriation   38
  5.8   Use of Distributors   38
ARTICLE 6   DILIGENCE   38
  6.1   Clinical Development Diligence   38
    (a)   Level of Effort   38
    (b)   Timetable   38
  6.2   Regular Reports on Development Activities   39
  6.3   Commercialization Diligence   39
    (a)   Level of Efforts   39
    (b)   Time to Launch Licensed Product   39
  6.4   Non-diligence   39
    (a)   Special Meeting of Collaboration Committee   39
    (b)   Supplemental Plan   40
    (c)   Non-Limitation of Remedies   40
ARTICLE 7   LICENSES   41
  7.1   Patent Licenses to GSK   41
  7.2   Patent Licenses to Gilead   41
  7.3   Know-How License to GSK   41
  7.4   Know-How License to Gilead   41
  7.5   Clinical Scope   42
  7.6   Trademark License   42
    (a)   Limited License for Gilead Marks   42
    (b)   Licensed Gilead Product Marks   42
    (c)   Standards for Using the Marks   42
  7.7   Third-Party Technology   43
  7.8   Sublicensed Technology   43
  7.9   Grants Back   44
  7.10   Sublicensing by GSK   44

iv

  7.11   Use of Patents and Know-How   44
  7.12   Cross-Territory Sales   44
  7.13   Exclusivity Commitment   45
  7.14   Right Relating to the HBV Indication   46
  7.15   No Implied Licenses   48
ARTICLE 8   MANUFACTURE AND SUPPLY   48
  8.1   Supply by Gilead   48
  8.2   GSK Manufacturing Right   48
  8.3   Clinical Supply Agreement   48
  8.4   Commercial Supply Agreement   49
  8.5   Consistency   51
  8.6   Additional Products   51
ARTICLE 9   COMPENSATION   51
  9.1   License Fee   51
  9.2   Milestone Payments   51
  9.3   Royalty on Net Sales   53
    (a)   Rates   53
    (b)   [ * ]   53
    (c)   Assumption Relating to Royalty Tier   54
    (b)   Term   54
    (c)   Payment for Non-Patent Benefits   54
    (d)   Example Calculation   55
    (e)   Quarterly Payments and Reconciliation   55
    (f)   Cross-Border Sales   56
    (i)   Korea and Taiwan   56
  9.4   Contract Revenue on [ * ]   57
    (a)   Rate   57
    (b)   Term   57
    (c)   [ * ]   57
  9.5   Annual Exclusivity Determination With Respect to China   58
  9.5   Combination and Bundled Products   59
    (a)   Combination Products   59
    (b)   Bundled Products   59
  9.7   Other Payments by Distributors and Permitted Sublicensees   59
  9.7   Third-Party Royalties and Other Payments   60
  9.8   Royalty Payments and Reports   60
  9.9   Taxes   60
  9.10   Blocked Currency   61
  9.11   Foreign Exchange   61
  9.12   Payments to or Reports by Affiliates   61
  9.13   Late Payments   61
  9.14   Accounting   61
  9.15   Third Party Licenses   62
  9.17   Compulsory Licenses   62
ARTICLE 10   INTELLECTUAL PROPERTY   63
  10.1   Ownership of Inventions   63
  10.2   Prosecution of Patents   63
    (a)   Gilead Patents   63
    (b)   GSK Patents   63
    (c)   Joint Patents   63

v

    (d)   ADV Patents   64
    (e)   Administrative Protections   64
  10.3   Patent Term Extensions   65
  10.4   Non-Patent Regulatory Exclusivity   65
  10.5   Infringement of Patents by Third Parties   65
    (a)   Notification   65
    (b)   Infringement of Gilead Patents   66
    (c)   Joint Patents   66
    (d)   Infringement of GSK Patents Outside the GSK Territory by Competitive Product Infringement   66
    (e)   Other Infringement of GSK Patents   67
    (f)   Settlement   67
    (g)   Allocation of Proceeds   67
  10.6   Infringement of Third Party Rights   68
    (a)   Notice   68
    (b)   Defense   68
    (c)   Settlement   68
  10.7   Patent Marking   68
  10.8   Selection and Registration of Product Trademarks   68
  10.9   Infringement of Trademarks by Third Parties   68
  10.10   Patent Oppositions   69
    (a)   Third-Party Patent Rights   69
    (b)   Parties' Patent Rights   69
    (c)   Noncontravention   69
ARTICLE 11   REPRESENTATIONS AND WARRANTIES   70
  11.1   Mutual Representations and Warranties   70
    (a)   Corporate Existence and Power   70
    (b)   Authority and Binding Agreement   70
    (c)   No Conflict   70
    (d)   Regulatory Data   70
    (e)   No Misappropriation   70
    (f)   No Debarment   70
    (g)   Rights in Technology   70
  11.2   Gilead   71
    (a)   Non-Infringement of Gilead Technology by Third Parties   71
    (b)   Non-infringement of Third Party Rights   71
    (c)   Claims   71
    (d)   Due Diligence   71
  11.3   Disclaimer   71
  11.4   No Other Representations   71
ARTICLE 12   INDEMNIFICATION   72
  12.1   Indemnification by Gilead   72
  12.2   Indemnification by GSK   72
  12.3   Procedure   72
  12.4   Insurance   73
  12.5   Limitation of Liability   73
ARTICLE 13   RECORDS; AUDITS; PUBLICATIONS   73
  13.1   Records; Audits   73
  13.2   Publications   74

vi

ARTICLE 14   CONFIDENTIALITY   74
  14.1   Treatment of Confidential Information   74
  14.2   Authorized Disclosure   74
  14.3   Publicity   75
ARTICLE 15   TERM AND TERMINATION   76
  15.1   Term   76
  15.2   Elective Termination   76
  15.3   Termination for Breach   77
    (a)   Notice   77
    (b)   Failure to Cure   77
    (c)   Disputes   77
  15.4   Fee upon Certain Terminations   77
  15.4   Termination for Bankruptcy/Insolvency   78
  15.5   Gilead Rights upon Certain Terminations of the Agreement or as to Certain Licensed Products   79
    (a)   Reverted Products   79
    (b)   Trademark License   79
    (c)   Regulatory Filings   79
    (d)   Technology Licenses   79
    (e)   No Further Representations   79
    (f)   Transition Assistance   80
    (g)   Remaining Inventories   80
  15.6   GSK Rights upon Certain Terminations   80
  15.7   Survival   81
ARTICLE 16   DISPUTE RESOLUTION   81
  16.1   Disputes   81
  16.2   Governing Law; Judicial Resolution   81
  16.3   Patent and Trademark Dispute Resolution   82
  16.4   Industry Expert Resolution of Certain Disputes   82
    (a)   Referable Issues   82
    (b)   Finality of Decision   82
    (c)   Industry Expert Resolutions   82
    (d)   Interim Performance; Costs   83
ARTICLE 17   MISCELLANEOUS   83
  17.1   Entire Agreement; Amendment   83
  17.2   Force Majeure   83
  17.3   Notices   84
  17.4   Maintenance of Records   85
  17.5   No Strict Construction   85
  17.6   Assignment   85
  17.7   Performance by Affiliates   85
  17.8   Further Actions   85
  17.9   Severability   86
  17.10   Headings   86
  17.11   No Waiver   86
  17.12   Counterparts   86

[ * ] = 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.

vii

[ * ] = 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 10.39


LICENSING AGREEMENT

        THIS LICENSING AGREEMENT (the "Agreement") is made effective as of April 26, 2002 (the "Effective Date") by and between GLAXO GROUP LIMITED, an English corporation having its principal place of business at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, England UB6 ONN ("GSK"), and GILEAD WORLD MARKETS, LIMITED, a Cayman Company whose registered address is Queensgate House, South Church Street, P.O. Box 1234GT, Grand Cayman, Cayman Islands ("Gilead"). Gilead and GSK are sometimes referred to herein individually as a "Party" and collectively as the "Parties."


RECITALS

        WHEREAS, Gilead is developing a proprietary compound known under the generic name of adefovir dipivoxil for the treatment of chronic hepatitis B;

        WHEREAS, Gilead has conducted and is currently conducting phase III clinical trials of such compound for such use in various countries, and is seeking or intends to seek regulatory approval in the United States, Canada, Europe, Australia and certain other countries of, and thereafter to Commercialize, such compound for such use in such countries;

        WHEREAS, GSK possesses extensive capabilities in various other countries (including China, Japan and other Asian countries) in the clinical development, manufacture, promotion and marketing of pharmaceutical products [ * ]; and

        WHEREAS, GSK desires to obtain the exclusive right to develop and Commercialize the same formulation and dosage of adefovir dipivoxil for hepatitis B in countries of interest to GSK as Gilead is developing in its countries of interest, and Gilead desires to grant GSK such rights in such countries of interest to GSK, all as set forth below;

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


ARTICLE 1

DEFINITIONS

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

        1.1    "Administrative Protection"  shall mean a right conferred by a Chinese governmental entity to exclude others from manufacturing or marketing a pharmaceutical product in China, other than by means of a Patent granted by the Chinese government. Notwithstanding