Study Milestone definition

Study Milestone means the enrollment of a patient in a Phase II study related to the AEVI-002 Program, the AEVI-006 Program or the AEVI-007 Program, prior to the twenty-four (24)-month anniversary of the date of this Agreement.
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Study Milestone the date for delivery of one or more Deliverables, as set out in the Technical Specification and Schedule of Study;
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Examples of Study Milestone in a sentence

  • Subject to Clause 2.5 of this Agreement, the date of the Provisional Acceptance Note shall constitute “Completion Date” with respect to the relevant Study Milestone and/or Deliverable.

  • The Contractor shall not commence provision of the Study until Study Start Date, as identified in accordance with Annex C: Schedule of Study and shall ensure that the Deliverables are furnished to the Principal on or before each relevant Study Milestone.

  • Although these measures are discretionary, see Sorrell, 395 F.3d at 337, utilizing them would avoid the factual disputes and questions of reasonableness that conceivably arise from an employer’s decision to classify an FMLA request as facially invalid without first working with the employee to resolve any discrepancies.

  • Meeting of a Study Milestone or supply of a Deliverable occurs whenever the Contractor has completed all of the Works which the Contractor has undertaken to perform according to the Annex B: Technical Specification and Schedule of Study by the relevant Study Milestone.

  • In no event will any CVR Payment Amount become payable (x) in respect the Study Milestone achieved or occurring on or after the twenty-four (24)-month anniversary of this Agreement, or (b) in respect of the NDA Milestone achieved or occurring on or after the sixty (60)-month anniversary.

  • He/she is also responsible for compiling the VMI fact book, creating data visualizations, and creating/maintaining digital-based dissemination of institutional data.c. The Assistant Director of Assessment is the primary liaison to faculty and staff regarding assessment and evaluation of student learning and operational outcomes (primarily at the program- or institutional-level).

  • The Provisional Completion Note shall include the Deliverable and adequate supporting Documentation and information relevant to the Study Milestone attained and/or Deliverable completed.

  • Review pre-requisites, content, and success criteria are documented in NPR 7123.1. 1.3 Study Milestone ScheduleThe Contractor shall execute the study in accordance with the following milestone schedule.

  • In the event that the Company cannot reach a decision on whether the XX Xxxxx 0 First Induction Study Milestone has been achieved, the Company may elect for such determination to be performed by an independent Third Party expert mutually appointed by the Parties in accordance with the Independent Expert Appointment Procedure.

  • The Contractor shall not commence provision of the Study until Study Start Date, as identified in accordance with Annex C (Schedule of Study) and shall ensure that the Deliverables are furnished to the Principal on or before each relevant Study Milestone.

Related to Study Milestone

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

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

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

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

  • 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.

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

  • 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).

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

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

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

  • 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 Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

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

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

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

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.