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License and Commercialization Agreement

 

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Title:

License and Commercialization Agreement

Entities:

Amgen, Inc.; InterMune, Inc.; Cooley Godward LLP

Date:

2001

Size:

116KB total

Price:

$55

ID:

#140479

 

 

► Licensing ► Commercializ. ► License & Commercialization Agreements
► Services ► Legal
► Biotech & Drugs ► Pharmaceutical Preparations
► Biotech & Drugs ► Biological Products

 

 

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    LICENSE AND COMMERCIALIZATION AGREEMENT

BY AND BETWEEN

AMGEN INC.

AND

INTERMUNE, INC.

June 15, 2001


TABLE OF CONTENTS

 
   
  Page
ARTICLE 1   DEFINITIONS   1
  1.1   "Active Component"   1
  1.2   "Affiliate"   1
  1.3   "Amgen Know-How"   1
  1.4   "Amgen Trademarks"   1
  1.5   "Amgen Patent"   2
  1.6   "Amgen Technology"   2
  1.7   "BLA"   2
  1.8   "CMC"   2
  1.9   "Combination Product"   2
  1.10   "Commercialize" or "Commercialization"   2
  1.11   "Commercially Reasonable Efforts"   2
  1.12   "Confidential Information"   2
  1.13   "Control"   2
  1.14   "Default"   2
  1.15   "Directly Competitive Product"   2
  1.16   "Dollar"   2
  1.17   "Drug Approval Application"   2
  1.18   "Existing License"   3
  1.19   "Existing License Patents"   3
  1.20   "Existing Licensor"   3
  1.21   "FDA"   3
  1.22   "Force Majeure"   3
  1.23   "GAAP"   3
  1.24   "Infergen"   3
  1.25   "IND"   3
  1.26   "Interferon alfacon-1"   3
  1.27   "Licensed Product"   3
  1.28   "Losses"   3
  1.29   "Net Sales"   3
  1.30   "Ongoing Clinical Trials"   3
  1.31   "Other Licensee"   3
  1.32   "Patent"   3
  1.33   "PEG Know-How"   4
  1.34   "PEG Patent"   4
  1.35   "PEG Program"   4
  1.36   "PEG-Infergen Product"   4
  1.37   "Phase III Clinical Trial"   4
  1.38   "Phase IV Clinical Trial"   4
  1.39   "Planning Period Date"   4
  1.40   "Regulatory Approval"   4
  1.41   "Regulatory Authority"   4
  1.42   "Royalty" or Royalties"   4
  1.43   "Sublicensee"   4
  1.44   "Supply Terms"   4
1.45   "Term"   4
  1.46   "Territory"   4
  1.47   "Third Party"   4
  1.48   "Trademark"   4
  1.49   "Valid Claim"   5
ARTICLE 2   LICENSES; EXCLUSIVITY; TRADEMARKS   5
  2.1   Technology Ownership   5
  2.2   Patent License to InterMune   5
  2.3   Trademark and Copyright Licenses to InterMune   5
  2.4   Know-How License to InterMune   5
  2.5   Sublicenses   5
  2.6   Sublicensed Technology   6

i


  2.7   Exclusivity   7
  2.8   Retained Rights.   7
  2.9   Import   7
  2.10   Covenant.   7
ARTICLE 3   DEVELOPMENT   7
  3.1   Ongoing Clinical Trials.   7
  3.2   PEGInfergen Products   7
  3.3   Development Efforts.   8
  3.4   Amgen Interim Activities.   8
  3.5   Development Data.   8
  3.6   Development Activities in Territory.   8
ARTICLE 4   REGULATORY   8
  4.1   General   8
  4.2   Additional Regulatory Filings   9
  4.3   InterMune Access to Amgen Regulatory Data   9
  4.4   Adverse Event Reporting; Customer Complaints   9
  4.5   Communications   10
  4.6   Applications for Regulatory Exclusivity   10
  4.7   Recalls and Voluntary Withdrawals.   10
  4.8   Safety and Clinical Database   10
ARTICLE 5   COMMERCIALIZATION   11
  5.1   Pricing   11
  5.2   Diligence   11
  5.3   Reports   11
  5.4   Amgen Transition Assistance   11
  5.5   Change of Promotional Material   11
  5.6   Medical and Other Inquiries   11
  5.7   Trade Returns; Reimbursements   12
  5.8   Distribution Agreements   12
ARTICLE 6   COMPENSATION   13
  6.1   License Fee   13
  6.2   Amgen Performance Milestones.   13
  6.3   Product Milestones   13
  6.4   Royalties   14
  6.5   Term of Royalties   14
  6.6   Combination Products   14
  6.7   Existing License Royalties   14
  6.8   Royalty Payments and Reports   15
  6.9   Taxes   15
  6.10   Blocked Currency   15
  6.11   Foreign Exchange   15
  6.12   Patent and Trademark Expenses   15
  6.13   Late Payments   15
ARTICLE 7   MANUFACTURE AND SUPPLY   16
  7.1   General.   16
ARTICLE 8   INTELLECTUAL PROPERTY   16
  8.1   Ownership of Inventions   16
  8.2   Prosecution of Patents   16
  8.3   Infringement of Patents and Trademarks by Third Parties   16
  8.4   Infringement of Third Party Rights   17
  8.5   Patent Marketing   17
ARTICLE 9   REPRESENTATIONS AND WARRANTIES   18
  9.1   Mutual Representations and Warranties   18
  9.2   Mutual Covenants   18
  9.3   Representations, Warranties and Covenants of InterMune   18
  9.4   Representations, Warranties and Covenants of Amgen   19
ARTICLE 10       20
  10.1   Indemnification by Amgen   20
  10.2   Indemnification by InterMune   20
  10.3   Insurance   20

ii


  10.4   Pre-Effective Date Losses.   21
  10.5   Limitation of Liability   21
ARTICLE 11   RECORDS; ROYALTY AUDIT; PUBLICATIONS   21
  11.1   Records; Royalty Audit   21
  11.2   Publications   21
ARTICLE 12   CONFIDENTIALITY   22
  12.1   Treatment of Confidential Information   22
  12.2   Authorized Disclosure   22
  12.3   Publicity; Terms of Agreement   22
ARTICLE 13   TERM AND TERMINATION   23
  13.1   Term   23
  13.2   Discontinuation of Commercialization or Further Development   23
  13.3   Termination for Default   23
  13.4   Licenses Upon Expiration   23
  13.5   Survival   24
  13.6   Determination of PEG Diligence.   24
ARTICLE 14   DISPUTE RESOLUTION   24
  14.1   Disputes   24
  14.2   Governing Law; Judicial Resolution   24
  14.3   Patent and Trademark Dispute Resolution   25
ARTICLE 15   MISCELLANEOUS   25
  15.1   Entire Agreement; Amendment   25
  15.2   Force Majeure   25
  15.3   Notices   25
  15.4   Maintenance of Records   26
  15.5   No Strict Construction   26
  15.6   Assignment   26
  15.7   Performance by Affiliates   26
  15.8   Counterparts   26
  15.9   Severability   26
  15.10   Headings   27
  15.11   Further Actions   27
  15.12   Independent Contractors   27
  15.13   Use of Name   27
  15.14   No Waiver   27

[*] = 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.

iii


LICENSE AND COMMERCIALIZATION AGREEMENT

    This License and Commercialization Agreement (the "Agreement") is made effective as of the 15th day of June, 2001 (the "Effective Date") by and between Amgen Inc., a Delaware corporation having its principal place of business at One Amgen Center Drive, Thousand Oaks, CA 91320-1799 ("Amgen") and InterMune, Inc., a Delaware corporation having its principal place of business at 1710 Gilbreth Road, Suite 310, Burlingame, CA 94010-1317 ("InterMune"). Amgen and InterMune are sometimes referred to herein individually as a "Party" and collectively as the "Parties", and references to "InterMune" and "Amgen" shall include their respective Affiliates.

Recitals

    Whereas, Amgen has bioengineered, developed, obtained regulatory approval for, and currently markets in the United States and Canada a pharmaceutical composition containing a novel, non-naturally occurring Type 1 interferon, sold under the trademark Infergen;

    Whereas, InterMune has clinically developed and currently markets an interferon-gamma product in the United States, and therefore has both clinical development experience and a sales force that may be particularly well suited to market and further develop a product such as Infergen;

    Whereas, InterMune desires to obtain, and Amgen wishes to grant InterMune, the exclusive license to commercialize and further develop Infergen in the United States and Canada on the terms and conditions set forth herein; and

    Whereas, Amgen is willing to supply InterMune, and InterMune wishes to be supplied by Amgen, with quantities of Infergen (as such term is defined below) on the Supply Terms (as defined 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 "Active Component" shall mean any product other than the Licensed Product which [*] therapeutic or prophylactic function when combined with the Licensed Product.

    1.2 "Affiliate" shall mean, except as provided below, a Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with Amgen or InterMune. For purposes of this definition, "control" shall mean the possession, direct or indirect, of the power to cause the direction of the management and policies of a Person, whether through ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise. Affiliate [*] shall [*]

    1.3 "Amgen Know-How" shall mean the following information: (1) information disclosed in the BLA for Infergen as of the Effective Date, (2) information disclosed as of the Effective Date in any BLA supplements for Infergen, (3) all Amgen-sponsored investigator-driven clinical trial results, and the results of the Ongoing Clinical Trials, (subject to any contractual confidentiality obligations of Amgen to Third Parties regarding such results); (4) Infergen sales and marketing training materials; (5) any regulatory data which Amgen provides to InterMune pursuant to Section 4.3; (6) [ * ]; (7) the safety and clinical database referenced in Section 4.8; and (8) Formulating Know-How (as defined in Section 12.1 of Exhibit F).

    1.4 "Amgen Trademarks" shall mean the registered trademarks listed at Exhibit A, all trademark applications listed at Exhibit A and all trademarks issuing from such applications, together with any renewals, modifications or extensions thereto.

1


    1.5 "Amgen Patent" shall mean [*]

    1.6 "Amgen Technology" shall mean all Amgen Patents, Amgen Know-How and Amgen Trademarks.

    1.7 "BLA" shall mean a Biological License Application for Regulatory Approval filed in the United States.

    1.8 "CMC" shall mean the Chemistry Manufacturing Control section of a BLA.

    1.9 "Combination Product" shall have the meaning assigned such term pursuant to Section 6.6.

    1.10 "Commercialize" or "Commercialization" shall mean those activities relating to the promotion, marketing and sale of Licensed Products and shall include without limitation, Phase IV Clinical Trials or equivalent clinical trials conducted following Regulatory Approval to market a pharmaceutical product.

    1.11 "Commercially Reasonable Efforts" shall mean the level of efforts and resources required to Commercialize a Licensed Product in a sustained manner consistent with the efforts a similarly situated biopharmaceutical company would typically devote to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing. Commercially Reasonable Efforts shall be determined on a country-by-country (each country including its territories) basis for a particular Licensed Product, and it is anticipated that the level of effort will change over time reflecting changes in the status of the Licensed Product and the country (including its territories) involved.

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


 

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