Recalls; Market Withdrawals. (a) Recall Procedures. Manufacturer and AAI shall each maintain such records as required by applicable Laws to permit effective recall, field correction or market withdrawal of Product delivered to AAI or customers of AAI, whether such recall, field correction or withdrawal is effected voluntarily or under a directive of any government and regulatory authority. Each Party agrees that in connection with a recall, field correction or market withdrawal, it shall provide copies of its relevant records to the other Party upon request, excluding confidential AAI customer information or information subject to attorney-client or other privilege. Each Party shall give immediate notice by telephone (to be confirmed in writing) to the other Party upon discovery that Product should be recalled, corrected or withdrawn from the market, or may be required to be recalled, corrected or withdrawn from the market. Except as otherwise set forth in this Section 13.2(a), the decision to initiate a recall or market withdrawal or to take any other corrective action shall be made solely by AAI. Manufacturer shall reasonably cooperate with AAI at the request of AAI in the implementation and management of such plan and in complying with all applicable regulatory obligations. Manufacturer may at any time notify AAI of its belief that AAI should recall, correct or market withdraw the Product. Notwithstanding anything to the contrary in this Section 13.2(a), if AAI disagrees with Manufacturer's assertion that a recall, market withdrawal or other corrective action should be initiated, then the Parties agree to submit the matter for review and binding determination by a mutually satisfactory and independent third party. In the event such third party concludes that a recall, market withdrawal or other corrective action is necessary, AAI shall so notify the FDA and initiate such required recall, market withdrawal or other field correction, as determined by such third party.
Recalls; Market Withdrawals. (a) Recall Procedures. Manufacturer and Company shall each maintain such records as required by applicable Laws and codes of practice to permit a recall, field correction or market withdrawal of any Product delivered to Company or customers of Company effected voluntarily or under a directive of any Government and Regulatory Authority. Each party agrees that, upon request in connection with a recall, field correction or market withdrawal, it shall provide copies of its relevant records to the other party upon request, excluding confidential customer information or information subject to attorney-client or other privilege. Each party shall give immediate notice by telephone (to be confirmed in writing) to the other party upon discovery that any Product should be recalled, corrected or withdrawn from the market, or may be required to be recalled, corrected or withdrawn from the market. The decision to initiate a recall or market withdrawal or to take any other corrective action shall be made by Company. While Manufacturer shall reasonably cooperate with Company in developing any necessary recall, market withdrawal or correction plan, the manner and extent of such plan shall be reasonably decided by Company. Manufacturer shall cooperate as reasonably required by Company in the implementation of such plan. The obligations under this Section 7.2(a) shall survive the termination of this Supply Agreement.
Recalls; Market Withdrawals
