FDA Letters Clause Samples
The FDA Letters clause outlines the obligations and procedures related to communications or formal letters received from the U.S. Food and Drug Administration (FDA) concerning a product or process. Typically, this clause requires parties to promptly notify each other upon receipt of any FDA correspondence, such as warning letters, notices of inspection, or requests for information, and may specify how to coordinate responses or share relevant information. Its core practical function is to ensure transparency and coordinated action in addressing regulatory issues, thereby minimizing compliance risks and facilitating timely responses to regulatory authorities.
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FDA Letters. As soon as practicable after the Closing, but in any event no later than three (3) Business Days following the Closing Date, Purchaser and Seller shall file Purchaser FDA Letters and Seller FDA Letters, respectively, with the FDA (in accordance with 21 C.F.R. § 314.72) providing notification of the transfer to Purchaser effective as of the Closing Date of the Purchased Regulatory Approvals; provided, that Purchaser’s obligation shall be conditioned on it receiving from Seller not less than three (3) Business Days prior to the Closing Date the complete regulatory file Controlled by Seller for all the relevant INDs and NDAs.
FDA Letters. (a) Each Seller shall, and shall cause its Affiliates to, cooperate with each Buyer Party and provide all assistance and information reasonably requested by any Buyer Party in connection with the preparation and submission of the Buyer FDA Letter, the Seller FDA Letter and all other approvals, consents, registrations, Permits, FDA Permits, authorizations and other confirmations required to be obtained from any Governmental Authority that are necessary to transfer the Regulatory Approvals contemplated by Section 2.01(i). The costs of relabeling Product would be for Buyer’s account.
(b) Each Seller shall cause each signatory to the Seller FDA Letter to duly execute the Seller FDA Letter at or prior to the Closing.
FDA Letters. Buyer and Seller shall file the Buyer FDA Intent Letters and the Seller FDA Intent Letters, respectively, with FDA within two Business Days after the Effective Date. Seller shall file the Seller FDA Transfer Letters with the FDA within [***] after the Closing. Buyer shall file the Buyer FDA Transfer Letters within one Business Day after receiving the complete copies of the Regulatory Approvals as required under 21 CFR §314.72(a)(2)(iii). Transfer of title to the Purchased Regulatory Approvals for the Products shall be effective as of the Delivery Date (as defined below) as to each such Product.
FDA Letters. Buyer and Seller shall file the Buyer FDA Transfer Letters and the Seller FDA Transfer Letters, respectively, with the FDA within five Business Days after the Closing Date. Transfer of title to the Purchased Regulatory Approvals shall be effective as of the Closing.
FDA Letters. Promptly after the Closing (but in no event later than two (2) Business Days following the Closing), Seller shall file, or cause to be filed, with the FDA the Seller FDA Letter, the Buyer FDA Letter, the Seller Orphan Designation Letter and the Buyer Orphan Designation Letter and shall provide an as-filed copy of each such letter to Buyer.
FDA Letters. Horizon and AstraZeneca shall file the Horizon FDA Intent Letters and the AstraZeneca FDA Intent Letters, respectively, with the FDA within one Business Day after the Closing Date. Horizon and AstraZeneca shall file the Horizon FDA Transfer Letters and the AstraZeneca FDA Transfer Letters, respectively, with the FDA pursuant to the Transition Agreement. Transfer of title to the NDA and the INDs for the Product shall be effective as of the Closing.
FDA Letters. The Research Foundation consents to, and otherwise ratifies, the action previously taken by B&H pursuant to the Royalty Agreement in executing and delivering the FDA Letters.
FDA Letters. No warning letter or untitled letter shall have been received from the United States Food and Drug Administration with respect to the Princeton Facility.
FDA Letters. Promptly after Closing (but in no event later than five (5) Business Days following the Closing):
(a) Cyclerion shall file, or cause to be filed, with the FDA the Cyclerion FDA Letters and the Cyclerion Orphan Designation Letter, and shall provide an as-filed copy of each such letter to Buyer.
(b) Buyers shall file, or cause to be filed, with the FDA the Buyer FDA Letters and the Buyer Orphan Designation Letter and shall provide an as-filed copy of each such letter to Cyclerion.
FDA Letters. The Ergo Parties shall deliver to PLIVA letters addressed to the FDA notifying the FDA of the transfer of ownership of the NDA for Cycloset to PLIVA, effective as of the Closing Date, and shall deliver to PLIVA such other instruments and documents as may be necessary to effect and record with the FDA the transfer to PLIVA of such NDA, any other NDA, IND or regulatory filing relating to the Products, and all data, documents and submissions relating thereto.