FDA Communications. Purchaser and Seller agree to promptly notify the other party in the event they receive any communication or notice from the FDA with respect to the Product or an inspection of the facility where the Product is manufactured, Packaged or stored, and each party shall promptly provide a copy of such communications to the extent applicable to the Product to the other. The parties shall cooperate in good faith in responding to any such FDA inquiry or in making any report to the FDA with respect to the Product, but in all cases Seller shall have final authority for regulatory decisions concerning the Product and responsibility for all communications with the FDA.
FDA Communications. Sandoz and Eagle agree to promptly notify the other party in the event they receive any communication or notice from FDA with respect to the AG Product and each party will promptly provide a copy of such communications to the other. The parties will cooperate in good faith in responding to any such FDA inquiry or in making any report to FDA with respect to the AG Product. Notwithstanding the foregoing, Eagle will have final authority for regulatory decisions and responsibility for all communications with FDA concerning the AG Product.
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. Journey and Blu agree, to promptly notify the other party in the event they receive any communication or notice from FDA with respect to the Journey Product or Doxycycline Hyclate and each party will promptly provide a copy of such communications to the other. The parties will cooperate in good faith in responding to any such FDA inquiry or in making any report to FDA with respect to the Journey Product. Journey will have the responsibility in the Territory for complying with all regulatory requirements and other matters which relate solely to Journey's acting as a distributor of the Journey Product in the Territory. All other regulatory reporting matters (including adverse event and product complaint reporting) will be Blu's responsibility for the Journey Product.
FDA Communications. Upon being contacted by the FDA for any regulatory ------------------ purpose related to the Product or the NDA for the Product, TEIKOKU shall immediately notify ENDO. ENDO shall be responsible for providing all responses directly to the FDA regarding inquiries related to the marketing, promotion, and/or sale of the Product, including any amendments or supplements to the NDA for the Product relating to its marketing, promotion and/or sale within the Territory and ENDO shall copy TEIKOKU USA with all such responses. TEIKOKU shall be responsible for providing all responses directly to the FDA regarding inquiries related to the manufacture, export, or import of the Product and TEIKOKU USA shall copy ENDO with all such responses.
FDA Communications. NPB represents and warrants that as of the Effective Date it has delivered to OSI copies of all written communications between NPB and the United States Food and Drug Administration (“FDA”) in connection with the Sensor Recall.
FDA Communications. Sandoz and Innovator agree to promptly notify the other party in the event they receive any communication or notice from FDA with respect to the Product and each party will promptly provide a copy of such communications to the other. The parties will cooperate in good faith in responding to any such FDA inquiry or in making any report to FDA with respect to the Product. Notwithstanding the foregoing, Innovator will have final authority for regulatory decisions and responsibility for all communications with FDA concerning the Product.
FDA Communications. During the term of this Agreement, PDC shall provide CytRx with copies of all material FDA and other regulatory agency correspondence relating to any Licensed Product or any of PDC’s activities under this Agreement and CytRx shall treat such copies and information as the Proprietary Information of PDC pursuant to Article III below.
FDA Communications. Upon termination of this Agreement, ECR shall take such steps as necessary to rescind its designation as NovaDel’s authorized agent for communications with FDA related to the Product.
FDA Communications. From and after the Closing Date, except with respect to the FDA Letter, as required by Applicable Law or as requested by Cumberland, Mylan shall not contact or communicate with the FDA or any other Governmental Authorities with respect to the Purchased Assets. Following the Closing Date, Mylan will notify Cumberland of its receipt of any correspondence from the FDA and, until the parties have delivered to the FDA the FDA Letter, it will use its commercially reasonable efforts to assist Cumberland in any response to the FDA in respect thereof.
