Priority Review definition

Priority Review means a priority review of and action upon a human drug application by the FDA not later than six (6) months after the filing of such application to the FDA, as defined in the FDA Act (21 U.S.C. 360ff).

Priority Review means review and action on a human drug application by the FDA in accordance with the timelines set forth by the FDA for “priority review” applications in the then-current Prescription Drug User Fee Act goals letter, as described in FDA Draft Guidance, “Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry” (July 2019).

Priority Review means review and action by the FDA on a human drug application in accordance with Section 529(a)(1) of the FDC Act.

Examples of Priority Review 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.

• Letterhead] May 8, 2024 [***] Re: NDA 218709 – Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 (the “Voucher”) Dear Sir or Madam: Reference is made to the above-referenced NDA approval letter dated April 26, 2024 reflecting the grant of the Voucher to X4 Pharmaceuticals, Inc.

• In the event that Buyer or any of its Affiliates uses (or notifies the FDA of its intent to use) the Priority Review Voucher in connection with a human drug application, Buyer or such Affiliate may, in any press release, public announcement or other disclosure relating to its filing (or proposed filing) of the relevant human drug application, disclose that the Priority Review Voucher acquired from Seller has been used (or is intended to be used) in connection with such human drug application.

• By: /s/ Xxxx Xxxxxxx Name: Xxxx Xxxxxxx Title: Chief Financial Officer Exhibit A Approval Letter Transfer of Priority Review Voucher Exhibit 2.3(b) Form of Seller Cover Letter [X4 Pharmaceuticals, Inc.

• 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”).

More Definitions of Priority Review

Priority Review means, with respect to the Product NDA, a designation assigned by the FDA pursuant to which the time it takes the FDA to review a NDA is reduced.

Priority Review means a design review service for an APP Type 4 permit application that the Department completes using not more than 50 percent of the total review time-frame for the applicable Type 4 permit application as specified in 18 A.A.C. 1, Table 10.

Priority Review means, with respect to a human drug application as defined in section 735(1) [21 USC § 379g(1)], review and action by the Secretary of HHS (“Secretary”) on such application not later than six (6) months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the FDA and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

Priority Review means a priority review of and action upon a human drug application, which is submitted under Section 505(b)(1) or 505(b)(2) of the FFDCA or under Section 351 of the Public Health Service Act, by the FDA not later than six (6) months after the receipt of such application by the FDA, as defined in Section 529(a)(1) of the FFDCA.

Priority Review means a review of a DAA by the applicable Regulatory Authority not later than six (6) months after the filing of DAA to such Regulatory Authority.

Priority Review procedure: used for drugs that treat serious conditions and present major therapeutic advances or provide treatment for a disease in which there is no suitable therapy. This procedure means that the time it takes the FDA to review an application is reduced to six months (instead of 10). Priority Review corresponds to the so-called “Accelerated Assessment” in Europe.

Priority Review means, with respect to a human drug application as defined in 21 USC § 379g(l), review and action by the Secretary of HHS (“Secretary”) on such application as described in the Manual of Policies and Procedures of the Food and Drug Administration (FDA) and goals identified in the letters described in Section 101(b) of the Prescription Drug User Fee Amendments of 2012.