FDA Communications Clause Samples
The FDA Communications clause defines how parties to an agreement will handle communications and interactions with the U.S. Food and Drug Administration (FDA) regarding the subject matter of their contract. Typically, this clause outlines which party is responsible for submitting information, responding to FDA inquiries, or notifying the other party about FDA communications or regulatory actions. For example, it may require one party to promptly inform the other of any FDA inspection results or correspondence that could impact the agreement. The core function of this clause is to ensure coordinated, transparent, and timely communication with the FDA, thereby minimizing regulatory risks and misunderstandings between the parties.
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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 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. 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. The Recipient will provide the Government with summaries of any Recipient formal meetings with the FDA and future correspondence between Recipient and the FDA regarding the manufacturing contemplated under this Agreement and ensure that Government representatives are invited to participate in any Recipient formal meetings with the FDA regarding topics that are material to Recipient's compliance with the terms of this Agreement.
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. 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. 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. 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 ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ and _____________________________________________________ (“Site”), each referred to herein individually as a “Party” and collectively as the “Parties.”
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. 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.
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.