Priority Review Voucher. LICENSEE will use Commercially Reasonable Efforts to assess the possibility of obtaining a priority review vouchers (“PRVs”) under Section 908 of the FDA Safety and Innovation Act and will diligently pursue such PRVs for each product developed. Should LICENSEE be awarded such a PRV for a Licensed Product, LICENSEE shall distribute to MSK twenty-five percent (25%) of income generated from the sale of any such PRV or the sale of other comparable incentive provided by any non-US jurisdiction. The Parties agree that the LICENSEE shall diligently seek to sell any PRV or other comparable incentive provided by any non-US jurisdiction unless the Parties agree otherwise in writing.
Priority Review Voucher. LICENSEE will use Commercially Reasonable Efforts to assess the possibility of obtaining a priority review vouchers (“PRVs”) under Section 908 of the FDA Safety and Innovation Act and will diligently pursue such PRVs for each product developed. Should LICENSEE be awarded such a PRV for the humanized 3F8 bi specific antibody as specified in MSK’s agreement with the Band of Parents (“BOP”), (hereinafter the “BOP PRV”), the BOP PRV shall be solely owned and controlled by MSK. LICENSEE shall assign all its rights in and to such BOP PRV to MSK. If MSK generates net income from the sale of the BOP PRV after meeting its contractual obligations with the BOP, MSK shall share fifty percent (50%) of such net income with LICENSEE. Any PRV that is not the BOP PRV will be owned by LICENSEE, LICENSEE shall distribute to MSK forty percent (40%) of income generated from the sale of the first such PRV. LICENSEE shall distribute to MSK one third (1/3) of income generated front sale of any subsequent PRV, or the sale of other comparable incentives provided by any non-U.S. jurisdiction. The Parties agree that the LICENSEE shall diligently seek to sell any PRV or other comparable incentive provided by any non-US jurisdiction unless the Parties agree otherwise in writing.
Priority Review Voucher. If either Party receives a Rare Pediatric Disease Priority Review Voucher for a Licensed Product pursuant to Section 529 of the FD&C Act enabling priority review, then the Parties agree that [**].
Priority Review Voucher. (a) If following the Effective Date Pharming or its Affiliate or Sublicensee receives a Priority Review Voucher in connection with its or their Development of the Licensed Compound or a Licensed Product, Pharming shall promptly notify Novartis in writing (a “PRV Notice”). Within [***] days of Novartis’ receipt of the PRV Notice, Novartis may elect by written notice to Pharming to purchase the Priority Review Voucher (a “PRV Purchase”). The consideration to be paid by Novartis to Pharming or its designee in connection with a PRV Purchase (“PRV Consideration”) shall equal: [***]. The PRV Consideration shall be paid to Pharming or its designee promptly following its determination in accordance with the terms of the PRV Documents.
Priority Review Voucher. (a)The Parties acknowledge that a Priority Review Voucher may be available and awarded to Eiger as the sponsor of the Progeria NDA (“Progeria PRV”). The Parties agree that, if awarded, Eiger will use commercially reasonable efforts to sell the Progeria PRV to a third party (“PRV Sale”) on commercially reasonable terms within twelve (12) months of the issuance of such Progeria PRV. Eiger agrees not to retain the Progeria PRV for itself or any of its Affiliates. [ * ].
Priority Review Voucher. If the Company receives the Current Product Voucher contemplated by section 5.3.1 of the License and Collaboration Agreement between Merck Xxxxxx & Dohme Corp. (“Merck”), Bioprotection Systems Corporation, and the Company, dated November 21, 2018, as amended and as the same may be amended from time to time, then the Company shall pay you (or a charity designated by you) an amount equal to one half of one percent (0.5%) of the net amount actually received by the Company (in the event of a sale of such voucher), or the portion of the Current Product Voucher Value retained by the Company (if such voucher is retained by the Company), in each case after deducting all amounts paid or payable by the Company to Merck, Public Health Canada (as defined therein), or any other third parties entitled to a share of such amounts, and after deducting any fees or costs incurred in obtaining or selling such voucher. The foregoing right shall expire if such voucher has not been issued to the Company by December 31, 2024.
Priority Review Voucher. (a) If ACADIA receives or has already received a Rare Paediatric Disease Priority Review Voucher from the FDA on approval of a NDA for any Product for any indication, ACADIA will pay to Neuren one third of the proceeds after applicable taxes from the sale of such voucher or the value if not sold but used by ACADIA in connection with filing an NDA with the FDA for a product other than a Product within […***…] days of delivery of the invoice with respect to such payment.
Priority Review Voucher. Any Priority Review Voucher awarded by the FDA to Dermelix or Exicure upon the Regulatory Approval for a Licensed Product in the US will be owned by Dermelix. Dermelix shall pay Exicure [***] of the net income received by Dermelix from the sale of the Priority Review Voucher to a third party. All payments and transfers will be made or effected within thirty (30) days after Dermelix’s receipt thereof.
Priority Review Voucher. In consideration for the rights and licenses granted in Section 2. and regardless of whether development or commercialization is undertaken by LICENSEE or its Sublicensees, LICENSEE shall pay to LICENSOR […***…] percent ([…***…]%) of (i) net cash receipts after payment of taxes and (ii) any other consideration; in each case, received by LICENSEE, its Affiliates and Sublicensees from its/their sale or transfer of a Priority Review Voucher, including a fair monetary value for any transaction that is not a bona fide arms-length transaction or that is for consideration other than monetary; in which case such consideration shall be valued at the fair market value determined as of the date of such transaction.
Priority Review Voucher. If Licensee elects to transfer to a Third Party or otherwise monetize a Priority Review Voucher, all proceeds thereof shall be allocated to Licensee.
