Common use of FDA Communications Clause in Contracts

FDA Communications. Purchaser and Seller agree to notify the other party promptly in the event they receive any communication or notice from the FDA or the DEA with respect to the Products, and each party shall promptly provide a copy of such communications to the other. The parties shall cooperate in good faith in responding to any such FDA or DEA inquiry or in making any report to the FDA or DEA with respect to the Products, but in all cases Seller shall have final authority for regulatory decisions concerning the Products and responsibility for all communications with the FDA and the DEA. Notwithstanding the foregoing, to the extent any such communication or decision relates solely to the Products (and not Seller’s branded version of the Products), then Seller shall not make such communication or decision without the prior consent of Purchaser, such consent not to be unreasonably withheld or delayed.

FDA Communications. Purchaser and Seller agree to promptly notify the other party promptly Party in the event they receive any communication or notice from the FDA or the DEA with respect to the Products, and each party Party shall promptly provide a copy of such communications to the other. The parties shall cooperate in good faith in responding to any such FDA or DEA inquiry or in making any report to the FDA or DEA with respect to the Products, but in all cases Seller shall have final authority for regulatory decisions concerning the Products and responsibility for all communications with the FDA and the DEAFDA. Notwithstanding the foregoing, to the extent any such communication or decision relates solely to the Products (and not Seller’s branded version of the Products), then Seller shall not make such communication or decision without the prior written consent of Purchaser, such consent not to be unreasonably withheld or delayed.