Initial Target Program definition

Initial Target Program has the meaning set forth in Section 5.1;
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Examples of Initial Target Program in a sentence

  • As soon as possible after the Effective Date, the Parties shall establish a joint project team (the “JPT”) which shall be initially responsible for the day-to-day operations of the Initial Target Program.

  • Initial Target Program Generation 2 *** · Project Selection: *** .

  • The JMC shall automatically cease to exist on completion of the Initial Target Program and the Second Target Program (if Adaptimmune conducts manufacturing activities under the Second Target Program), as the case may be, and completion of the technology transfer requirements set forth in Section 6.11 and Schedule 7 as they relate to the Initial Target Program and Second Target Program, respectively.

  • The JMC shall be formed within thirty (30) days after the Effective Date and shall include three (3) representatives from each Party (or such other number as mutually agreed by the Parties), in each case suitably qualified to assist in the development and co-ordination of the manufacturing process development forming part of the Initial Target Program, including process, analytical, quality and supply expertise.

  • The JMC will coordinate with the JPT assigned to the Initial Target Program as required or useful, will report to the JSC and will be responsible for the day-to-day management of the manufacturing process development activity within the Initial Target Program including proposing amendments to the Development Plan regarding such manufacturing processes for review by JSC.

  • Where GSK terminates the Initial Target Program under this Section 13.2 *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

  • The closing times of succeeding Lots may be extended also to allow for a minimum closing time between the closing times of each Lot.

  • Thereafter, the Research Plan for the first Initial Target Program shall be further updated when reasonable, to include detailed Clinical Trial design and other matters that cannot reasonably be addressed as of the Effective Date or the [***] period referred to above.

  • The Research Plan agreed to by the Parties prior to the Effective Date governing the first Initial Target Program is set forth in Schedule 1; provided, that such Research Plan shall be updated by the JSC within [***] of the establishment of the JSC to include additional details of specific activities and timelines required to achieve the Lead Candidate Criteria and Development Candidate Criteria.

  • Initial Target Program Generation 2 *** : · *** · *** · *** · *** · Project Selection: *** *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Related to Initial Target Program

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Plans has the meaning set forth in Section 3.2.

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

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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.

  • Program Period means the period of time which the department intends to support the program without requiring the recompetition for funds. The program period is specified within the grant application.

  • 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.

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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.

  • Research Program has the meaning set forth in Section 2.1.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Research Budget has the meaning set forth in Section 4.2.

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

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

  • Commercialization Plan has the meaning set forth in Section 6.2.