Phase II Milestones definition

Phase II Milestones means Borrower’s achievement of each of the following: (i) achievement of the primary endpoint with respect to the
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Phase II Milestones means the milestones established by the Parties in writing at the commencement of Phase II which milestones are directed at achieving the Objective;
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Phase II Milestones means means Borrower’s achievement of each of the following: (i) achievement of primary endpoint from the Phase 2b clinical trial of tomivosertib in patients with non-small cell lung cancer after first radiographic progression of pembrolizumab monotherapy, in connection with xxxxxxxxxxxxxx.xxx identifier #NCT04622007 and (ii) initiating at least one (1) Phase 2 trial of Zotatafin; as evidenced by the issuance of a press release by Borrower announcing same.
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Examples of Phase II Milestones in a sentence

  • The Project Plan will establish: (i) the scope of the development activities which will be performed during each of Phase I and, if applicable, Phase II; (ii) objectives, work plan activities and time schedules with respect to the Project; and (iii) the Feasibility Milestone for Phase I and, if applicable, Phase II Milestone(s).

  • Phase II will be completed upon completion of the Phase II Milestones or, if earlier, expiration of the time period agreed by the Parties for the conduct of Phase II, unless terminated earlier in accordance with clause 14.

  • Upon achievement of the Feasibility Milestone, the Parties will promptly negotiate bona fide in good faith (i) whether to conduct Phase II, (ii) the duration of Phase II, (iii) the research funding to be provided in connection with Phase II, and (iv) appropriate modifications to the Project Plan to establish the Phase II Milestone(s) and the activities to be undertaken by the Parties in Phase II.

  • Phase II Milestones, Deliverables and Work Distribution between the Contractor and Lifespan/Rhode Island Hospital (L/RIH) for Clinical Development of IPdR as a Radiosensitizer.Site L/RIH Obiective 1.

Related to Phase II Milestones

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

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

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

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

  • 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.

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

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

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

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

  • 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 Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

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

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

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

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Final Completion Date means the date on which Final Completion occurs.

  • 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 I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).