Phase 2 Milestone definition

Phase 2 Milestone means initiation of first dosing of a patient in a Phase 2 Clinical Trial.
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Phase 2 Milestone shall have the meaning set forth in Section 1.11(a)(ii).
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Phase 2 Milestone means the Commencement of a Phase 2 Trial.
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Examples of Phase 2 Milestone in a sentence

  • If this Agreement is terminated with respect to any Nuvelo Product or Archemix Product pursuant to Section 12.1(a) or (b) after the achievement of the Phase 2 Milestone, then the Parties shall pay to each other royalties as set forth below, and the procedures set forth in Sections 7.4(b)(iii) through (vi) shall apply to both Parties (in the case when Archemix is the royalty paying Party, such provisions shall apply to Archemix correlatively).

  • No later than sixty (60) days after the IND Milestone Reference Date, in the case of the first occurrence of the IND Milestone, or sixty (60) days after the date of the first occurrence of the Phase 2 Milestone, Parent shall (i) provide written notice (a “Regulatory Milestone Statement”) to the Stockholder Representative of the occurrence of such Regulatory Milestone and (ii) subject to Article VI, pay, or cause to be paid, the corresponding Contingent Payment in accordance with Section 1.7(a).

  • If Archemix terminates the Collaboration pursuant to Section 13.1(b) or Nuvelo terminates the Collaboration pursuant to Section 13.1(a) before the achievement of the Phase 2 Milestone, then Nuvelo’s obligation to pay the Phase 2 Milestone payment shall survive the termination of the Collaboration.

  • Subject to the terms and conditions of this Agreement, Nuvelo shall pay to Archemix $10,000,000 within 10 days after the achievement of the Phase 2 Milestone.

Related to Phase 2 Milestone

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

  • 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;

  • 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 Event has the meaning set forth in Section 8.4.

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

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

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

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

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

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

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

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

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

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • 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 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • 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 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 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 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.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.