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. 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. 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 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. (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. (i) Within five (5) Business Days of the Closing Date, the Seller shall transmit to Purchaser, via encrypted thumb drive, the complete files for the Acquired Regulatory Approvals (in electronic format) and concurrently submit the Seller FDA Letters to the FDA, notifying the FDA that the Acquired Regulatory Approvals have been transferred to the Purchaser. For clarity, the Seller FDA Letters shall appear as a sequence in such Acquired Regulatory Approvals.
(ii) Within five (5) Business Days of the Purchaser’s receipt of the Acquired Regulatory Approvals pursuant to Section 2.01(f)(i), the Purchaser shall (A) upload such files into the Purchaser’s regulatory operations system and confirm in writing to the Seller the successful uploading of such files, (B) submit the Purchaser FDA Letters to the FDA, notifying the FDA that the transfer of ownership of the Acquired Regulatory Approvals has been accepted by the Purchaser, and (C) provide an electronic copy of the Purchaser FDA Letters to the Seller (including a copy of the Purchaser FDA Letters submission sequence).
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. 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. 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.
