IMMUNEX TERRITORY Sample Clauses

IMMUNEX 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 Immunex Territory. Immunex and Wyeth shall cooperate in the handling and disposition of such recall, market withdrawal or correction in the Immunex 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, Immunex, after consultation with Wyeth, shall have final authority with respect to such matters in the Immunex Territory, which authority shall be exercised reasonably in and in good faith. Immunex shall bear the cost of all recalls, market withdrawals, or corrections of Bulk Drug Substance, Finished Product, Drug Product, or Product Supply in the Immunex Territory unless such recall, market withdrawal or correction shall have ---------- *Confidential Treatment Requested. been the result of any breach of Wyeth's covenants, representations, or warranties set forth in this Agreement or shall have been the result of Wyeth's grossly negligent breach of any of its obligations hereunder, in which case Wyeth shall, upon substantiation, bear the cost of such recall, market withdrawal, or correction. Immunex 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 Immunex Territory.
Sample 1
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IMMUNEX TERRITORY. This Agreement may be terminated by Immunex (after consultation with Wyeth) solely with respect to the Immunex Territory upon at least [*] prior written notice to BIP if the BLA for the Product is withdrawn by Immunex. In such event, unless Wyeth has terminated the Agreement with respect to the Wyeth Territory pursuant to Section 19.2(d)(2) below, Wyeth 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
IMMUNEX TERRITORY. Immunex shall maintain complaint files in accordance with cGMP for the Immunex Territory. BIP shall provide Immunex and Wyeth with a copy of any complaints received by BIP from the Immunex Territory with respect to the Product within [*] ([*]) hours of receipt of notice thereof. Immunex shall promptly provide BIP and Wyeth with a copy of any complaints received by Immunex from the Immunex Territory relating to the manufacture of the Product. Immunex or its designee shall have responsibility for responding to all complaints from the Immunex Territory, and for promptly providing BIP and Wyeth with a copy of any responses to complaints, relating to the manufacture of the Product. Immunex or its designee shall have responsibility for reporting any complaints relating to the Product from the Immunex Territory to the FDA and any other regulatory authority in the Immunex 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 Immunex, with a copy to Wyeth, within [*] ([*]) days of a written request therefor with respect to any complaint by a Third Party in the Immunex Territory regarding the manufacturing, packaging or storage of the Product by BIP.
Sample 1
IMMUNEX TERRITORY. (1) BIP shall provide Immunex 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 Immunex regulatory filings with respect to the Product in the Immunex Territory, which records shall be in BIP's standard formats unless otherwise agreed upon by Immunex and BIP. (2) BIP shall provide Immunex with all documents reasonably requested by Immunex relating to the FDA's and EMEA's pre-approval inspection of the Biberach Facility, including, but not limited to, development reports, chemistry, manufacturing and controls ("CMC") sections of Immunex's BLA for the Product, as well as available stability data. In addition, BIP and Wyeth shall each provide Immunex 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 Immunex for the preparation of the annual report with respect to the manufacturing and control of the Product for such annual reporting period. Thereafter, Immunex shall provide to BIP and Wyeth at least [*] ([*]) days prior to Immunex's filing with the respective regulatory authorities a copy of such Immunex annual report, and Immunex shall take into consideration any BIP and Wyeth comments to such annual report with respect to the Product.
Sample 1

Related to IMMUNEX 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.

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

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

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • 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.

  • Licensed Patent Rights The term “Licensed Patent Rights” shall mean rights arising out of or resulting from:

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