WYETH TERRITORY Sample Clauses

WYETH TERRITORY. Each Party shall notify the other Party promptly (and, in any event, within [*] business days of receipt of written notice) if any Bulk Drug Substance, Finished Product, Drug Product, or Product Supply is alleged or proven to be the subject of a recall, market withdrawal or correction in any country in the Wyeth Territory. Immunex and Wyeth shall cooperate in the handling and disposition of such recall, market withdrawal or correction in the Wyeth Territory; provided, however, that in the event of disagreement as to any matters related to such recall, market withdrawal or correction, other than the determination of who shall bear the costs as set forth in the immediately following sentence, Wyeth, after consultation with Immunex, shall have final authority with respect to such matters in the Wyeth Territory, which authority shall be exercised reasonably in and in good faith. Wyeth shall bear the cost of all recalls, market withdrawals, or corrections of Bulk Drug Substance, Finished Product, Drug Product, or Product Supply in the Wyeth Territory unless such recall, market withdrawal or correction shall have been the result of any breach of Immunex's covenants, representations, or warranties set forth in this Agreement or shall have been the result of Immunex's grossly negligent breach of any of its obligations hereunder, in which case Immunex shall, upon substantiation, bear the cost of such recall, market withdrawal, or correction. Wyeth or its agent shall in all events be responsible for conducting any recalls, market withdrawals or corrections with respect to Bulk Substance, Finished Product, Drug Product, or Product Supply in the Wyeth Territory.
Sample 1
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WYETH TERRITORY. This Agreement may be terminated by Wyeth (after consultation with Immunex) solely with respect to the Wyeth Territory upon at least [*] prior written notice to BIP if (i) the EMEA-dossier for the Product is not approved by the EMEA by [*] or (ii) the Product is not commercialized in the Wyeth Territory for any reason. In such event, Immunex and BIP shall thereafter enter into good faith negotiations to amend this Agreement by making any necessary and appropriate revisions as may be mutually agreed upon.
Sample 1
WYETH TERRITORY. Wyeth shall maintain complaint files in accordance with cGMP for the Wyeth Territory. BIP shall provide Wyeth and Immunex with a copy of any complaints received by BIP from the Wyeth Territory with respect to the Product within [*] ([*]) hours of receipt of notice thereof. Wyeth shall promptly provide BIP and Immunex with a copy of any complaints received by Wyeth from the Wyeth Territory relating to the manufacture of the Product. Wyeth or its designee shall have responsibility for responding to all complaints from the Wyeth Territory, and for promptly providing BIP and Immunex with a copy of any responses to complaints, relating to the manufacture of the Product. Wyeth or its designee shall have responsibility for reporting any complaints relating to the Product from the Wyeth Territory to the EMEA and any other regulatory authority in the Wyeth Territory, including, but not limited to, complaints relating to the manufacture of the Product, as well as adverse drug experience reports. BIP shall provide a response to Wyeth, with a copy to Immunex, within [*] ([*]) days of a written request therefor with respect to any complaint by a Third Party in the Wyeth Territory regarding the manufacturing, packaging or storage of the Product by BIP.
Sample 1
WYETH TERRITORY. (1) BIP shall provide Wyeth in a timely manner with a copy of any BIP manufacturing and control records for Bulk Drug Substance, Drug Product and Finished Product which are required for any Wyeth regulatory filings with respect to the Product in the Wyeth Territory, which records shall be in BIP's standard formats unless otherwise agreed upon by Wyeth and BIP.
Sample 1

Related to WYETH TERRITORY

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Joint Patent Rights If not already established under the Research Collaboration Agreement, prior to either Party filing any Patent Right disclosing Joint Program Technology or Joint TAP Platform Improvements, the Parties shall establish a patent committee (the “Patent Committee”) comprised of at least one (1) representative of each Party for the purpose of facilitating the preparation, filing, prosecution, maintenance and defense of Joint Patent Rights. As agreed upon by the Parties, meetings of the Patent Committee may be face-to-face or may be conducted by teleconferences or videoconferences, from time to time as needed. The Patent Committee will be the forum through which the Parties coordinate their respective obligations to each other described in Sections 5.2.2 and 5.2.3 hereof and in this Section. In the event the Parties conceive or generate any Joint Program [***] Certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by CytomX Therapeutics, Inc. Technology or Joint TAP Platform Improvements, the Parties shall promptly meet to discuss and determine, based on mutual consent, whether to seek patent protection thereon, which Party will control filing, prosecution and maintenance of such patents and how to pay for the filing, prosecution and maintenance of such patents. It is presumed that CytomX will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Program Technology or Joint Unconjugated Probody Platform Improvements, and that ImmunoGen will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint TAP Platform Improvements or Joint Conjugation Probody Platform Improvements. Neither Party will file any Joint Patent Right without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Party controlling filing and prosecution of any such Joint Patent Right (a) shall keep the other Party informed regarding each Patent Right, (b) shall consider in good faith any recommendations made by the other Party in regard to the filing, prosecution or maintenance of any such Patent Right and (c) shall not unreasonably refuse to incorporate any recommendations made by the other Party in regard to such filing, prosecution or maintenance.

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