Examples of FFDCA in a sentence
The Parties agree that the user fees to be paid in connection with the use of the Priority Review Voucher by Buyer or any subsequent transferee of the Priority Review Voucher, and all other user fees under the FFDCA applicable to the human drug application for which the Priority Review Voucher is redeemed, shall be borne exclusively by Buyer or any such subsequent transferee of the Priority Review Voucher.
Seller shall, and shall cause its Affiliates and each of their respective successors in interest and assigns to, within the Marketing Period, Market in the United States the Rare Pediatric Disease product for which the Priority Review Voucher was awarded under applicable Legal Requirements to preclude the FDA from exercising its authority to revoke the Priority Review Voucher pursuant to Section 529(e)(1) of the FFDCA (the “Marketing Requirement”).
Buyer acknowledges that it is responsible for notifying the FDA of the transfer of the Purchased Assets and the delivery to the FDA of the letters referenced in Section 2.3(b), in accordance with the requirements of Section 529(b)(2)(B) of the FFDCA and as further described in the FDA’s Draft Guidance, “Rare Pediatric Disease Priority Review Vouchers —Guidance for Industry” (July 2019).
Except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect, no Loan Party has received any written notice of adverse filing, warning letter, untitled letter or other correspondence or written notice in respect of the Product from FDA or any other relevant regulatory authority or other Governmental Authority alleging or asserting noncompliance with FFDCA or similar U.S. federal or state or non-U.S. Law.