FDA Letters Sample Clauses

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), (a) Seller shall file, or cause to be filed, with the FDA the Seller FDA Letters and provide a copy of the as-filed Seller FDA Letters to Buyer, and (b) Buyer shall file, or cause to be filed, with the FDA the Buyer FDA Letters and provide a copy of the as-filed Buyer FDA Letters to Seller.

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) On or before [***] ([***])[***] after the Closing Date, Seller shall deliver the Seller FDA Transfer Letters to the FDA providing notice to the FDA of the transfer of the ownership of the Product Registrations to TJL Purchaser. On or before [***] ([***])[***] after the Closing Date, Purchasers shall deliver the Purchaser FDA Transfer Letters to the FDA notifying the FDA of TJL Purchaser’s ownership of the Product Registrations and its acceptance of the regulatory responsibilities associated with the Product Registrations from Seller. Portions of this Exhibit, indicated by the mxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (b) Promptly after the Closing and in any event within [***] ([***])[***] after the Closing, Seller and Purchasers shall make all appropriate filings and submissions with Governmental Authorities, including the Centers for Medicare & Medicaid Services and the FDA to register appropriate NDC Numbers in the name of the TJL Purchaser and transfer all regulatory responsibilities, excluding all Excluded Liabilities attaching thereto of each Product, from Seller to TJL Purchaser. (c) In accordance with the foregoing Section 6.7(a) and Section 6.7(b), (i) Seller shall use all commercially reasonable efforts to complete the transfer of the corresponding Product Registrations as promptly as practicable after the Closing Date to the benefit of TJL Purchaser and (ii) Purchasers shall use all commercially reasonable efforts to assist Seller in the transfer of such Product Registrations, accept the transfer of the corresponding Product Registrations and formalize with Sellers and any applicable Governmental Authority, as promptly as practicable after the Closing Date, all necessary documents. Following the transfer of the Product Registrations, Sellers shall retain no rights in the Product Registrations or Regulatory Documentation, including any rights to use or reference.

FDA Letters. (i) Within five [***] of the Closing, the Seller shall submit the Seller FDA Letter to the FDA, notifying the FDA that the Acquired Regulatory Approvals have been transferred to Purchaser. (ii) Within [***] of the Closing, the Purchaser shall submit the Purchaser FDA Letter to the FDA, notifying the FDA that the Acquired Regulatory Approvals have been accepted by the Purchaser.

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. (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 Letters and Seller FDA Letters, respectively, with FDA within [***] after the Closing Date; provided that Buyer's obligation shall be conditioned on it receiving from Seller not less than [***] prior to the Closing Date the complete regulatory file from Seller for all the relevant INDs and NDAs. Transfer of title to the NDA and the INDs for the Product shall be effective as of the Closing.

FDA Letters. (a) Seller shall file the Seller FDA Letter, with FDA no later than [***] and shall provide Buyer with notice of such filing at the time of filing.

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.