FDA Priority Review Voucher Sample Clauses

FDA Priority Review Voucher. 6.12.1 If EPIZYME, its Affiliate or Sublicensee is awarded a PRV in connection with the NDA for any Licensed Product, and EPIZYME, such Affiliate or Sublicensee thereafter sells such PRV to a Third Party, EPIZYME shall pay to EISAI [**] percent ([**]%) of the total consideration that EPIZYME, such Affiliate or Sublicensee receives for such sale within ten (10) Business Days after receipt of such consideration. EPIZYME shall notify EISAI of the execution by EPIZYME, its Affiliate or Sublicensee of any agreement for the sale of such PRV to a Third Party and shall provide to EISAI a complete copy of such sale agreement within ten (10) Business Days after such execution. In case any such consideration received by EPIZYME, such Affiliate or Sublicensee is non-cash consideration, the value of such non-cash consideration shall be determined in good faith by the Parties. 6.12.2 If EPIZYME, its Affiliate or Sublicensee is awarded a PRV in connection with the NDA for any Licensed Product, and EPIZYME, such Affiliate or Sublicensee thereafter redeems such PRV for use with any product other than a Licensed Product, then (a) not later than ten (10) Business Days after the date of such redemption (the “Redemption Date”) EPIZYME shall notify EISAI of such redemption, and (b) not later than [**] days after the Redemption Date, pay to EISAI an amount equal to [**] percent ([**]%) of the mean of the sales prices of the [**] PRVs most recently sold by Third Parties prior to the Redemption Date. For the avoidance of doubt, no compensation shall be payable by EPIZYME to EISAI under this Section 6.12.2 if EPIZYME, its Affiliate or Sublicensee redeems a PRV for use with a Licensed Product. 6.12.3 If the Parties are unable to reach agreement as to a valuation pursuant to Section 6.12.1 or 6.12.2, the Parties will refer such matter to a jointly selected Third Party with expertise in the pricing of pharmaceutical products that is not an employee, consultant, legal advisor, officer, director or stockholder of, and does not have any conflict of interest with respect to, either Party for resolution. If the Parties are unable to agree on such a Third Party expert within thirty (30) days after a Party has notified the other Party that it desires to refer such matter to such a Third Party for resolution, either Party may request that the New York, New York office of the AAA appoint such an expert to resolve such matter. The resolution determined by any such expert that is either jointly ...
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FDA Priority Review Voucher. If Licensee receives a voucher under the FDA’s priority review voucher program, Licensee may sell or otherwise commercialize such voucher, if Licensee pays Licensor twenty-five percent (25%) of all proceeds related to the sale of such voucher within thirty (30) days after receipt of such proceeds.
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FDA Priority Review Voucher. Should the specific phage products being collaborated on between the Parties qualify for and be awarded a priority review voucher, or equivalent, under US or EU law, the Parties agree to equally share any benefit obtained therefrom. The Parties agree to discuss the application, disposition, or use of any such voucher. Final_June 2013 12 Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
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FDA Priority Review Voucher. If Licensee receives a voucher under the FDA’s priority review voucher program, Licensee may sell or otherwise commercialize such voucher, if Licensee pays Licensor [**] percent ([**]%) of all proceeds related to the sale of such voucher within [**] after receipt of such proceeds.
Sample 1

Related to FDA Priority Review Voucher

  • 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).

  • 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.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • ADB’s Review of Procurement Decisions 11. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan.

  • 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • 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.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

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