Priority Review Voucher definition

Priority Review Voucher means a voucher issued by the FDA to the sponsor of a rare pediatric disease product application, as such term is defined in 21 U.S.C. § 360ff, which entitles the holder of such voucher to priority review of an NDA after the date of approval of the rare pediatric disease product application.

Priority Review Voucher means the priority review voucher issued by the United States Secretary of Health and Human Services, Food and Drug Administration, to Seller, as evidenced in the Approval Letter, identified by priority review voucher number PRV BLA 125755/0.

Priority Review Voucher means a priority review voucher granted by the FDA solely with respect to any Product Candidate and not with respect to any other product candidate of the Warrant Holder.

Examples of Priority Review Voucher in a sentence

• Seller has provided to Buyer true and complete copies of the Approval Letter and all other material written correspondence between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher, in each case, (a) with such redactions to any portion of the Approval Letter and such other material written correspondence that is not relevant to the Priority Review Voucher and (b) including any and all corrections with respect thereto.

• Neither Seller nor any of its Affiliates has notified the FDA, or permitted any Third Party to notify the FDA, of intent to use the Priority Review Voucher.

• 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.

• Seller shall promptly forward to Buyer any communications or notices it or its Affiliates receive from any Governmental Entity to the extent relating directly or indirectly to or otherwise materially impacting the Purchased Assets; provided, that Seller may redact any portion of such written communications or other notices that is not relevant to the Priority Review Voucher.

• There is no term or condition imposed by the FDA as of the date hereof on the Priority Review Voucher that is not set forth in the Approval Letter or provided for under applicable Law.

More Definitions of Priority Review Voucher

Priority Review Voucher means a voucher issued by

Priority Review Voucher means a priority review voucher issued by the United States Department of Health and Human Services that entitles the holder of such voucher to Priority Review of a single human drug application submitted under Section 505(b)(1) of the Act or Section 351(a) of the [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. United States Public Health Service Act, as further defined in Section 529(a)(2) of the Act (21 U.S.C. § 360ff(a)(2)).

Priority Review Voucher means the priority review voucher issued by the United States Department of Health and Human Services to Seller, as the sponsor of a rare pediatric disease product application, and assigned tracking number PRV NDA 210365, that entitles the holder of such voucher to Priority Review of a single human drug application submitted under section 505(b)(1) of the FDC Act or Section 3511(a) of the United States Public Health Service Act, as further defined in section 529(a)(2) of the FDC Act (21 USC 360ff(a)(2)), as evidenced by the NDA Approval Letter.

Priority Review Voucher or “PRV” means a priority review voucher issued by the United States Secretary of Health and Human Services to the sponsor of a rare pediatric disease product application or a qualifying tropical disease product application, that may be transferred and entitles the holder of such voucher to Priority Review of a single human drug application submitted under section 505(b)(1) or section 351(a) of the United States Public Health Service Act.

Priority Review Voucher means the priority review voucher assigned tracking number PRV NDA 214662 issued by the Secretary of the Department of Health and Human Services pursuant to Section 529(b)(1) of the FFDCA to Seller, as evidenced by the Approval Letters, that entitles the holder to Priority Review of a single human drug application.

Priority Review Voucher means a voucher issued by the Secretary to the Licensee for a rare pediatric disease product application that entitles Licensee or Licensee’s transferee of such voucher to Priority Review of a human drug application submitted under section 505(b)(1) [21 USC § 355(b)(1)] or section 351(a) of the Public Health Service Act [42 USC § 262] after the date of approval of the rare pediatric disease product application. For the purposes of this Agreement, Priority Review Voucher refers to any such voucher that the Licensee obtains as a result of its activities that relied upon Licensed Products or Licensed Processes.

Priority Review Voucher means a voucher issued by the Secretary to the sponsor of a tropical disease product that entitles such sponsor, or a person described under sub- section (b)(2), to priority review of a new drug application submitted under section 505(b)(1) after the date of approval of the tropical disease product.