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. 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. 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 Americas 92425100 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. (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.
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 *** Material has been omitted pursuant to a request for confidential treatment and has been filed separately. Table of Contents 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.
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. 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. Promptly after Closing (but in no event later than five (5) Business Days following the Closing):
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.
FDA Letters. The Buyer and the Company shall, on the Closing Date, have filed, or caused to be filed, through the electronic gateway, the Buyer FDA Letters and the Company FDA Letters, respectively, with the FDA.
