WYETH TERRITORY Sample Clauses

WYETH TERRITORY. Each Party shall notify the other Parties promptly (and in any event within [*] days of receipt of written notice) if any Batch of Bulk Drug Substance, Drug Product or Finished Product is alleged or proven to be the subject of a recall, market withdrawal or correction in any country in the Wyeth Territory. Wyeth and BIP shall cooperate in the handling and disposition of such recall, market withdrawal or correction in the Wyeth Territory; provided, however, in the event of a 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 and in good faith. Wyeth shall bear the cost of all recalls, market withdrawals or corrections of Bulk Drug Substance, Drug Product or Finished Product in the Wyeth Territory unless such recall, market withdrawal or correction shall have been the result of BIP's breach of any of its warranties set forth in Section 6.1 hereof or shall have been the result of BIP's grossly negligent breach of any of its obligations hereunder, in which case BIP 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 the Product in the Wyeth Territory.
Sample 1
AutoNDA by SimpleDocs
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respect to the Wyeth Territory upon at least [*] prior written notice to BIP if the EMEA-dossier for the Product is withdrawn by Wyeth or any of its Affiliates. In such event, unless Immunex has terminated the Agreement with respect to the Immunex Territory pursuant to Section 19.2(d)(1) above, 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. (2) BIP shall provide Wyeth with all documents reasonably requested by Wyeth relating to the FDA's and EMEA's pre-approval inspection of the Biberach Facility, including, but not limited to, development reports, CMC sections of Wyeth's EMEA-dossier for the Product, as well as available stability data. In addition, BIP and Immunex shall each provide Wyeth within [*] ([*]) days after the end of each annual reporting period for the Product (as calculated consistent with appropriate regulations and guidelines) with such information as is reasonably requested in writing by Wyeth for the preparation of the annual report with respect to the manufacturing and control of the Product for such annual reporting period. Thereafter, Wyeth shall provide to BIP and Immunex at least [*] ([*]) days prior to Wyeth's filing with the respective regulatory authorities a copy of such Wyeth annual report, and Wyeth shall take into consideration any BIP and Immunex comments to such annual report with respect to the Product.
Sample 1

Related to WYETH TERRITORY

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • 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.

  • 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.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

  • 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 Probody 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 Technology or Joint Probody 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 ImmunoGen will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Program Technology or Joint Conjugation Probody Platform Improvements, and that CytomX will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Unconjugated 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.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!