Priority Review Vouchers Sample Clauses

Priority Review Vouchers. If, in connection with a Product, a Regulatory Authority grants Praxis credits, reduced fees, priority review or any other incentives including those offered under 21 U.S.C. § 360ff or 21 U.S.C. § 360n-l (each, a “Regulatory Authority Incentive”)Praxis transfers such Regulatory Authority Incentive to a Third Party for consideration, then within [***] after such transfer, Praxis will pay Ionis [***]. If Praxis transfers such Regulatory Authority Incentive to a Third Party in exchange for non-cash consideration, then within [***] after such transfer, Praxis and Ionis will discuss and
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Priority Review Vouchers. 12.1 The Purchaser and its Affiliates shall use their Commercially Reasonable Efforts to obtain Sale PRVs including but not limited to submitting a voucher request in the submission of the applicable biological licensing application. 12.2 The parties agree that the first Sale PRV (if any) legally granted to the Purchaser or its Affiliates shall beneficially belong to the Seller with effect from the Completion Date. The Purchaser shall transfer legal ownership to the first such Sale PRV that it receives to the Seller. The Purchaser shall, at least once every [***], and in any event on reasonable request of the Seller, inform the Seller of the status of any such Sale PRV process. For the avoidance of doubt, other than the first such Sale PRV which shall be subject to the terms of this clause 12.1, the Purchaser or its Affiliates shall retain full ownership of any other PRV(s) obtained at any time, subject to the Seller’s right of acquisition set out in clause 12.3. 12.3 Following receipt and transfer of the first Sale PRV to the Seller, the Purchaser shall inform the Seller promptly of receipt of any subsequent Sale PRV granted to the Purchaser or its Affiliate relating to a Royalty Product, and the Seller shall following receipt of such notification have the exclusive right to acquire such Sale PRV for [***]. The Seller shall, within [***] of receipt of notice from the Purchaser, either (i) confirm it wishes to acquire the Sale PRV, or (ii) confirm that it does not wish to acquire the Sale PRV provided that if no notice has been received by the Purchaser from the Seller by the end of such [***] period, the Seller shall be considered to have confirmed that it does not wish to acquire the Sale PRV. 12.4 In the event that the Seller wishes to acquire the Sale PRV, it shall do so within [***] of the date of the notice given by the Seller pursuant to clause 12.3. [***] 12.5 If the Seller does not wish to acquire the Sale PRV and in the event of any subsequent sale of the Sale PRV by the Purchaser or its Affiliate to a third party for a price equal to or in excess of [***] and the Purchaser shall within [***] of receipt of such amounts pay to the Seller an amount equal to [***] of any amount actually received by the Purchaser or its Affiliate in excess of [***]. 12.6 For the avoidance of doubt if the Seller does not wish to acquire the Sale PRV (as described in clause 12.3 above) the Purchaser shall not be obliged to sell the Sale PRV but may, at its discretion, ...
Priority Review Vouchers. If a U.S. FDA priority review voucher is obtained for a Licensed Product, it may only be used for a subsequent BLA filing for another Licensed Product or another product of Prevail or its Affiliates, or sold. If such priority review voucher is sold by Prevail to a Third Party, Prevail will pay Precision a priority review voucher fee in the amount of [***]. If however, the priority review voucher is used for a product of Prevail or its Affiliates other than a Licensed Product, Prevail will pay Precision a priority review voucher fee in the amount [***].
Priority Review Vouchers. If a U.S. FDA priority review voucher is obtained for a Licensed Product, it may only be used for a subsequent BLA filing for another Licensed Product or another product of Lilly or its Affiliates, or sold. If WEIL:\97737446\1\59474.0121 EXECUTION VERSION such priority review voucher is sold by Lilly to a Third Party, Lilly will pay Precision a priority review voucher fee in the amount of [***]. If however, the priority review voucher is used for a product of Lilly or its Affiliates other than a Licensed Product, Lilly will pay Precision a priority review voucher fee in the amount of [***].
Priority Review Vouchers. In the event Parent or an affiliate secures from the FDA a Priority Review Voucher (“RPV”) pursuant to Section 529 of the Federal Food, Drug and Cosmetic Act with respect to Company Technology and sells that voucher, Parent will pay to Company [REDACTED]% of the net receipts received by the Parent or affiliate from the sale after deduction of costs relating to the development of the applicable Company Technology, including allocable overhead and out of pocket expenses for pre-clinical and clinical development, regulatory and other consultants, legal, accounting, etc. (“RPV Net Receipts”).
Priority Review Vouchers. If, in connection with a Licensed Product, a Regulatory Authority grants ProQR credits, reduced fees, priority review or any other incentives including those offered under 21 U.S.C. § 360ff or 21 U.S.C. § 360n-1 (each, a “Regulatory Authority Incentive”) and ProQR transfers such Regulatory Authority Incentive to a Third Party for consideration, [***] as Net Sales in the Calendar Quarter in which such consideration is received, and royalties will be due and paid thereon at the Full Royalty Rate within [***] after receipt of such consideration and in accordance with Section 5.6.
Priority Review Vouchers. If, in connection with a Product, a Regulatory Authority grants Dynacure credits, reduced fees, priority review or any other incentives including those offered under 21 U.S.C. § 360ff or 21 U.S.C. § 360n-l (each, a “Regulatory Authority Incentive”) and Dynacure transfers such Regulatory Authority Incentive to a Third Party for consideration, then within [***] after such transfer, Dynacure will pay Ionis the Agreed Percentage (as defined below) of any consideration Dynacure received from such Third Party transferee for the applicable transfer. If Dynacure uses such a Regulatory Authority Incentive in connection with a non-Product or transfers such Regulatory [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. Authority Incentive to a Third Party in exchange for non-cash consideration, then within [***] after such use or transfer, Dynacure and Ionis will discuss and mutually agree on the fair market value of such Regulatory Authority Incentive (including, if applicable, the value of any non-cash consideration received by Dynacure) and Dynacure will pay Ionis the Agreed Percentage (as defined below) of such fair market value in cash. If Ionis and Dynacure cannot agree on the fair market value of the Regulatory Authority Incentive within [***] after such use or transfer, then the matter will be decided by a Third Party expert selected by mutual agreement by the Parties whose determination will be final and binding on both Parties. If the Parties cannot agree on a Third Party expert, the dispute resolution provisions of Section 16.4 will govern. The Agreed Percentage shall be equal to [***] less the percentage of Ionis’ holding in the share capital of Dynacure on a fully diluted basis.
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Priority Review Vouchers. After exercising the Option for a particular Collaboration Program, if Biogen receives a Priority Review Voucher from the FDA for the applicable Development Candidate or Product, the following provisions will apply: (a) Biogen will be the sole and exclusive owner of such Priority Review Voucher; (b) if Biogen [***] or [***] such Priority Review Voucher [***], then [***] such Priority Review Voucher will [***] for the applicable [***] in the [***] which [***] is [***], subject to all applicable [***]; and (c) Biogen will determine, in its sole discretion, whether to [***] the Priority Review Voucher [***] or [***] the Priority Review Voucher [***]. If Biogen determines to [***] the Priority Review Voucher [***], then Biogen will consider in good faith [***], to the [***] the Priority Review Voucher [***] or any of the [***].

Related to Priority Review Vouchers

  • Seniority Verification Process i. The new school district shall provide the employee with the necessary verification form at the time the employee achieves continuing contract status. ii. The employee must initiate the seniority verification process and forward the necessary verification forms to the previous school district(s) within ninety (90) days of receiving a continuing appointment in the new school district. iii. The previous school district(s) shall make every reasonable effort to retrieve and verify the seniority credits which the employee seeks to port.

  • Claims Review Population A description of the Population subject to the Claims Review.

  • Claims Review Report The IRO shall prepare a Claims Review Report as described in this Appendix for each Claims Review performed. The following information shall be included in the Claims Review Report for each Discovery Sample and Full Sample (if applicable).

  • Claims Review The IRO shall perform the Claims Review annually to cover each of the five Reporting Periods. The IRO shall perform all components of each Claims Review.

  • Sick Leave Verification Process a. The new school district shall provide the employee with the necessary verification form at the time the employee receives confirmation of employment in the school district. b. An employee must initiate the sick leave verification process and forward the necessary verification forms to the previous school district(s) within ninety (90) days of commencing employment with the new school district. c. The previous school district(s) shall make every reasonable effort to retrieve and verify the sick leave credits which the employee seeks to port.

  • Claims Review Methodology ‌‌ a. C laims Review Population. A description of the Population subject‌‌ to the Quarterly Claims Review.

  • Seniority Rosters The Employer agrees to furnish the Union each January 31 and July 31 with rosters of all employees who accrue seniority, their current and prior classifications, and start date in each classification and University start date per Section 1. Employees who have accepted positions outside the bargaining unit do not accrue class seniority in the bargaining unit when employed in positions outside the bargaining unit, but retain prior seniority earned in the bargaining unit. When two (2) or more employees have the same classification seniority date, ties shall be broken by recognizing the employee with the greater University seniority first. If a tie still continues, the employee's seniority position shall be determined by lot.

  • Seniority Roster The District shall maintain an updated seniority roster, indicating employee's class seniority and hire date seniority. Such rosters shall be available to CSEA.

  • System Security Review All systems processing and/or storing County PHI or PI must have at least an annual system risk assessment/security review which provides assurance that administrative, physical, and technical controls are functioning effectively and providing adequate levels of protection. Reviews should include vulnerability scanning tools.

  • Log Reviews All systems processing and/or storing PHI COUNTY discloses to 11 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 12 must have a routine procedure in place to review system logs for unauthorized access.

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