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. 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. 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 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 inquiry or in making any report to the FDA 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. 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.
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. Upon termination of this Agreement, Mist shall take such steps as necessary to rescind Mist’s or its designated Affiliate’s, as the case may be, designation as NovaDel’s authorized agent for communications with FDA related to the Product.
FDA Communications. Communications with the FDA will be a shared MGH and Company responsibility. Open-label Extension Study We strongly encourage including open-label extension study for all Regimens. All costs related to the OLE study will be provided by the Company. These costs are not included below and will be negotiated separately. Financial Commitment In addition to the Company responsibilities outlined above, Company shall provide $[***], as follows: ● Platform: $[***] to be used towards ongoing support of the ALS Platform Trial’s core CCC and DCC activities. ● Regimen: $[***] to be used to support the activities specifically related to the Regimen study of Company’s investigational product. EXHIBIT B MASTER SITE CLINICAL TRIAL AGREEMENT This Master Site Clinical Trial Agreement (“Agreement”) is entered into by and between The General Hospital Corporation d/b/a Massachusetts General Hospital (“MGH”), a not-for-profit corporation organized under the laws of Massachusetts with its principal place of business at 00 Xxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 and _____________________________________________________ (“Site”), each referred to herein individually as a “Party” and collectively as the “Parties.”
FDA Communications. The parties agree that all communication by either party regarding commercial compliance issues, with the FDA and other related governmental agencies, with respect to Product(s) Packaged and Labeled hereunder and the terms of this Agreement, shall be coordinated between the parties and shall not occur without ENDO’s prior written consent.
