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Title: |
License and Commercialization Agreement |
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Entities: |
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Date: |
2001 |
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116KB total |
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$55 |
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ID: |
#140479 |
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LICENSE AND COMMERCIALIZATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
INTERMUNE, INC.
June 15, 2001
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Page
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|---|---|---|---|---|---|
| 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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