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Title: |
Contract Manufacturing Agreement |
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Date: |
2001 |
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Preview shows 7KB of 74KB total |
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$48 |
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ID: |
#326464 |
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CONTRACT MANUFACTURING AGREEMENT
This CONTRACT MANUFACTURING AGREEMENT (the "Agreement") is entered into as of October 16, 2000 (the "Effective Date"), by and between ICOS Corporation ("ICOS"), a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 22021 20th Avenue SE, Bothell, WA 98021 USA and Seattle Genetics, Inc. ("SGI"), a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 22215 26th Avenue S.E., Suite 3000, Bothell, WA 98021.
RECITALS
WHEREAS, ICOS is in the business of manufacturing and testing pharmaceutical products; and
WHEREAS, SGI is the proprietor of a certain cDNA known as SGN 30 [*], encoding monoclonal antibodies also known as SGN 30 [*]; and
WHEREAS, ICOS has expertise in the development, evaluation and production of monoclonal antibodies for therapeutic use using cell lines; and
WHEREAS, subject to the terms and conditions set forth in this Agreement, SGI wishes to have ICOS manufacture for SGI a pre-commercial pharmaceutical Product (hereinafter defined); and
WHEREAS, subject to the terms and conditions set forth in this Agreement, ICOS wishes to manufacture Product for SGI.
NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:
1. Definitions
For purposes of this Agreement, the following terms will have the meanings set forth below:
1.1 "Affiliates" means, with respect to any Person, another Person that, directly or indirectly, controls, is controlled by or is under common control with such Person. The term "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise. The direct or indirect ownership of at least fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of the voting securities of a business entity or of an interest in the assets, profits or earnings of a Person shall be deemed to constitute "control" of the Person.
1.2 "Applicable Laws" means all applicable ordinances, rules and regulations of any kind whatsoever of any governmental or regulatory authority, including, without limitation, the FDCA.
1.3 "Audit" means a review by SGI or their appointed representatives (such representatives to be reasonably acceptable to ICOS) of applicable processes, procedures and documents.
1.4 "Calendar Quarter" means the three-month period ending on March 31, June 30, September 30 or December 31. The initial Calendar Quarter will be deemed to begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 of such same year.
1.5 "Calendar Year" means the twelve (12) month period ending on December 31. The initial Calendar Year will be deemed to begin on the Effective Date and end on December 31 of such same year.
[*] Confidential treatment requested
1
1.6 "Cell Line" means a [*] cell line known as [*], which has been transfected with a [*] containing certain SGI Materials as described in Appendix B, and will be used to provide the Services herein. Any cell bank provided containing the transfected cell line will be always subject to the license granted under Appendix G herein.
1.7 "cGMP" means Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610).
1.8 "Damages" means any and all reasonable costs, losses, claims, actions, liabilities, fines, penalties, costs and expenses, court costs, and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a party hereto (including interest which may be imposed in connection therewith).
1.9 "FDA" means the United States Food and Drug Administration, any comparable agency in any Foreign Jurisdiction, and any successor agency or entity to any of the foregoing that may be established hereafter.
1.10 "FDCA" means the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.).
1.11 "FOB" means ICOS has fulfilled its obligation to deliver when it has made the object of delivery available at its premises to SGI or SGI's agent (or to SGI's carrier). For the avoidance of doubt, unless otherwise agreed in writing, ICOS is not responsible for loading the object of delivery on to the vehicle provided by SGI or SGI's agent (or to ICOS's nominated carrier) or for delaying the object of delivery for export.
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