Clinical Efficacy Milestone Payment Trigger Date definition

Clinical Efficacy Milestone Payment Trigger Date means the earlier to occur of: (a) December 31, 2016 and (b) the later to occur of (i) the achievement of the Clinical Efficacy Milestone and (ii) the earlier of (A) the date twelve (12) months after the Parties’ agreement as to the form and substance of the KHK Agreement Amendment pursuant to Section 2.5 or (B) the date ninety (90) days after AVEO enters into the KHK Agreement Amendment pursuant to Section 2.5.
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Examples of Clinical Efficacy Milestone Payment Trigger Date in a sentence

  • If upon exercise of the Option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, AVEO shall be entitled to the Clinical Efficacy Milestone Payment at such time that the Clinical Efficacy Milestone Payment Date does occur if the license agreement remains in effect as of such date.

  • Ophthotech may exercise the Option at any time until the latest to occur of: (i) twelve (12) months after the achievement of the Clinical Efficacy Milestone, (ii) ninety (90) days after the Clinical Efficacy Milestone Payment Trigger Date, and (iii) thirty (30) days after AVEO and Ophthotech agree as to the definitive form of license agreement (the “Option Period”).

  • Notwithstanding the foregoing, such payment shall not be payable if Ophthotech gives AVEO a notice of termination pursuant to Section 9.5 on or prior to the date [**] days after the Clinical Efficacy Milestone Payment Trigger Date, whether or not such termination becomes effective prior to the date [**] days after the Clinical Efficacy Milestone Payment Trigger Date.

  • If, at the time Ophthotech exercises the Option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, Ophthotech shall pay the milestone set forth in Section 4.3 after such Option exercise at such time as the Clinical Efficacy Milestone Payment Trigger Date does occur if the License Agreement remains in effect as of such subsequent occurrence.

  • In consideration for the grant of the Option and the provision by AVEO of the AVEO Materials, Ophthotech shall pay AVEO a one-time milestone payment of six million Dollars ($6,000,000) within [**] days after the Clinical Efficacy Milestone Payment Trigger Date.

Related to Clinical Efficacy Milestone Payment Trigger Date

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Milestone Event has the meaning set forth in Section 8.4.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone Payments has the meaning set forth in Section 4.2.

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.