IMMUNEX 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 Immunex Territory. Immunex and BIP shall cooperate in the handling and disposition of such recall, market withdrawal or correction in the Immunex 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, Immunex, after consultation with Wyeth, shall have final authority with respect to such matters in the Immunex Territory, which authority shall be exercised reasonably and in good faith. Immunex shall bear the cost of all recalls, market withdrawals or corrections of Bulk Drug Substance, Drug Product or Finished Product in the Immunex 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. Immunex or its agent shall in all events be responsible for conducting any recalls, market withdrawals or corrections with respect to the Product in the Immunex Territory.
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with respect to the Immunex Territory upon at least [*] prior written notice to BIP if the BLA for the Product is withdrawn by Immunex.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.
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.
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.
