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.
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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 [***].
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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.
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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:
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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. 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”).
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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 [***].
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Related to Priority Review Vouchers

  • Completion of Review for Certain Review Receivables Following the delivery of the list of the Review Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Review Receivable is paid in full by the Obligor or purchased from the Issuer in accordance with the terms of the Basic Documents. On receipt of such notice, the Asset Representations Reviewer will immediately terminate all Tests of the related Review Receivable, and the Review of such Review Receivables will be considered complete (a “Test Complete”). In this case, the related Review Report will indicate a Test Complete for such Review Receivable and the related reason.

  • Asset Representations Review Process Section 3.01 Asset Representations Review Notices and Identification of Review Receivables. On receipt of an Asset Representations Review Notice from the Seller according to Section 5.7 of the Receivables Purchase Agreement, the Asset Representations Reviewer will start an Asset Representations Review. The Servicer will provide the list of Review Receivables to the Asset Representations Reviewer promptly upon receipt of the Asset Representations Review Notice. The Asset Representations Reviewer will not be obligated to start, and will not start, an Asset Representations Review until an Asset Representations Review Notice and the related list of Review Receivables is received. The Asset Representations Reviewer is not obligated to verify (i) whether the conditions to the initiation of the Asset Representations Review and the issuance of an Asset Representations Review Notice described in Section 7.6 of the Indenture were satisfied or (ii) the accuracy or completeness of the list of Review Receivables provided by the Servicer.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Maintenance of Review Materials It will maintain copies of any Review Materials, Review Reports and other documents relating to a Review, including internal correspondence and work papers, for a period of at least two years after any termination of this Agreement.

  • Claims and Review Procedures 6.1 For all claims other than Disability benefits:

  • Review of Documentation The Depositor, by execution and delivery hereof, acknowledges receipt of the Mortgage Files pertaining to the Mortgage Loans listed on the Mortgage Loan Schedule, subject to review thereof by Xxxxx Fargo Bank National Association, LaSalle Bank National Association, Deutsche Bank National Trust Company and U.S. Bank National Association as applicable (each, a “Custodian” and, together, the “Custodians”), for the Depositor. Each Custodian is required to review, within 45 days following the Closing Date, each applicable Mortgage File. If in the course of such review the related Custodian identifies any Material Defect, the Seller shall be obligated to cure such Material Defect or to repurchase the related Mortgage Loan from the Depositor (or, at the direction of and on behalf of the Depositor, from the Trust Fund), or to substitute a Qualifying Substitute Mortgage Loan therefor, in each case to the same extent and in the same manner as the Depositor is obligated to the Trustee and the Trust Fund under Section 2.02(c) of the Trust Agreement.

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