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. 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. 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) 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. [ * ].
(b) PRF and Eiger shall share the proceeds of any PRV Sale [ * ]. For clarity, as used in this Section 6(b), “proceeds” means the gross amounts received by Eiger with respect to any PRV Sale, less applicable taxes on such amounts.
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.
(b) The sale and transfer of a Priority Review Voucher to Novartis or its designee pursuant to Section 5.10(a) shall be consummated pursuant to documents and instruments mutually agreed between Novartis and Pharming which shall be consistent with terms and conditions customary in the industry for the purchase and sale of Priority Review Vouchers save for the PRV Consideration and provisions related thereto (the “PRV Documents”). If Novartis exercises its option to purchase a Priority Review Voucher under Section 5.10(a), Novartis and Pharming shall negotiate in good faith and seek to agree on the form and substance of PRV Documents consistent with the terms of this Agreement within [***] days of Novartis’ election. In the event the Parties do not execute and deliver PRV Documents within such [***] day period, either Party may refer such matter for resolution in accordance with the dispute resolution procedures contained in Section 15.5.
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.
(b) For the purposes of this clause 15.2, if:
(i) a Priority Review Voucher is sold to an independent Third Party, the sale value will be the amount paid or to be paid by that Third Party or, if any part of the consideration for the sale is not in cash, the market value of such non‑cash consideration less applicable taxes on such sale or transfer (but in any event, excluding tax on the income of ACADIA resulting from such sale); and
(ii) a Priority Review Voucher is not sold at all or is not sold to an independent Third Party and ACADIA submits it to the FDA with the corresponding NDA for any product other than a Product, the sale value will be the average price paid by purchasers of Rare Paediatric Disease Priority Review Vouchers in the last 3 publicly announced sales of such vouchers by any holders to independent third parties immediately preceding the issuance of the priority review voucher to ACADIA.
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.
Priority Review Voucher. (i) Loxo shall assign to Bayer, without additional consideration, and Bayer shall accept any priority review voucher (the “Voucher”) issued by the U.S. Secretary of Health and Human Services in connection with a Licensed Compound to Loxo that 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, as further defined in the FDC Act.
(ii) In furtherance thereof (a) Loxo shall perform all actions necessary to facilitate the transfer of the Voucher to Bayer, and upon such transfer, all of the right, title and interest of Seller in and to the Voucher shall pass to Bayer and (b) the Parties will prepare a letter for submission to the FDA, and will submit such letter, notifying the FDA of the transfer of the Voucher. The Parties agree to cooperate and assist each other with respect to all filings or notifications to any Governmental Entity related to the transfer and assignment of the Voucher.
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. [****] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Should LICENSEE be awarded such a PRV for a Licensed Product, LICENSEE shall distribute to MSK [****] 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.
