Communications with FDA Clause Samples
The "Communications with FDA" clause defines how parties to an agreement will handle interactions and correspondence with the U.S. Food and Drug Administration (FDA). Typically, this clause outlines which party is responsible for submitting regulatory documents, notifying the other party of FDA communications, and sharing relevant information or updates. For example, it may require one party to promptly inform the other of any FDA inquiries, inspection results, or regulatory actions related to the product or project. The core function of this clause is to ensure transparency and coordination in regulatory matters, minimizing the risk of miscommunication and ensuring compliance with FDA requirements.
Communications with FDA. All communications with FDA concerning any Detailed Product shall be the sole responsibility of Wyeth. Impax shall provide reasonable assistance to Wyeth to the extent deemed necessary by Wyeth to fully respond to such communications.
Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Relypsa and, unless required by Applicable Law, shall be initiated solely by Relypsa. Sanofi shall provide to Relypsa prompt notice if the FDA or other governmental authority in the Territory contacts Sanofi regarding the Product. Commencing upon the date that the label for the Product has been established by the FDA, Relypsa shall provide to Sanofi [***] notice of [***] with the FDA or other governmental authority in the Territory with respect to the Product which would [***] or is [***]. Sanofi shall provide reasonable assistance, at [***], to Relypsa with respect to any such communications or interactions with the FDA described in this Section 5.6 to the extent deemed necessary by Relypsa.
Communications with FDA. Notwithstanding anything to the contrary in this Agreement, BIND will be solely responsible for communicating with the FDA or comparable regulatory authority regarding the Study, the Study Results or services hereunder, and USOR shall not contact the FDA or such other regulatory authority regarding the Study, the Study Results or services hereunder unless required by Applicable Law or requested by BIND in writing.
Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Solvay and shall be initiated solely by Solvay. Solvay shall keep CV Therapeutics promptly informed (including as provided in Sections 2.3(b) and 7.1 above), and shall provide CV Therapeutics promptly with all Solvay minutes and correspondence relating to teleconferences, meetings or other interactions with FDA with respect to the Product, and with copies of all FDA minutes and correspondence relating to the same. Solvay shall notify CV Therapeutics in advance of any planned communication with the FDA, and shall cooperate with CV Therapeutics regarding regulatory strategy for the Product as provided in Sections 2.3(b) and 7.1 above. CV Therapeutics, at its own expense, shall provide reasonable assistance to Solvay to the extent deemed necessary by Solvay to fully respond to such communications and shall have the right to participate in such communications with FDA, at CV Therapeutics’ discretion, as provided in Section 7.1.
Communications with FDA. All communications with the FDA concerning the Product will be the sole responsibility of GSK and will be initiated solely by GSK. GSK will keep Allergan informed of any material interactions with FDA with respect to the Product. Allergan, at its own expense, will provide reasonable assistance to GSK to the extent deemed necessary by GSK.
Communications with FDA. After the Effective Date, Nycomed shall provide BioSante with copies of all correspondence and documents to and from the FDA with respect to the Product in its possession, and all notices received from the FDA related thereto, within three (3) business days following transmission or receipt from the FDA. However, after the Effective Date, Nycomed shall not communicate with the FDA with respect to the Product. BioSante shall be responsible for all communications with the FDA with respect to the Product after the Effective Date.
Communications with FDA. Neauvia shall have the sole right and responsibility to make any communications to or respond to any inquiries from the FDA or any other regulatory agency related to the Products.
Communications with FDA