Preclinical Development Plan definition

Preclinical Development Plan means a Development Plan directly relating to a Preclinical Study.
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Preclinical Development Plan means, for each Program, the comprehensive plan, overall strategy and timelines, and any updates thereto, for the Preclinical Development of Products directed to the applicable Target for such Program, including a description of the Preclinical Development activities, expected timelines, the preclinical, clinical, manufacturing, regulatory, as well as product risk assessment planned activities up to the issuance of the Final Report by Kite to Amgen. The Preclinical Development Plan shall include, but not be limited to, a reasonably detailed description of the schedule of work activity, the responsibility for the work activities and an associated budget. As the circumstances may require, the JSC may propose from time to time amendments to the Preclinical Development Plan in accordance with Section 2.1.3(b) (Function and Powers of the JSC).
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Preclinical Development Plan has the meaning set forth in Section 4.01 (Joint Development in the Field in the Territory) hereof.
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Examples of Preclinical Development Plan in a sentence

  • For clarity, after completion of the Preclinical Development Plan, Amgen shall continue to have the right to conduct preclinical development with respect to all Amgen Products.

  • Preclinical Development Plan: · Pre-clinical pharmacokinetic and ADME studies including bioanalytical method development: Analytical methods to be used during the GLP toxicology and clinical studies will be established and tested in these non-GLP preclinical studies.

  • Except to the extent included in a Preclinical Development Plan funded pursuant to Section 8.1.3 (Preclinical Development Costs), Kite shall be solely responsible for, and shall bear all costs associated with, the manufacture of Kite Products.

  • Pursuant to the foregoing, upon approval by the JSC of the first Preclinical Development Plan for an Amgen Target, Kite shall elect to either itself serve or have a Kite CMO serve as the manufacturer of Amgen Products directed against such Amgen Target.

  • Detractors are wary of government intervention in schools that is not directly connected to academic achievement.

  • Upon approval by the JSC of the applicable Preclinical Development Plan and associated Budget, each Party shall commence and conduct Preclinical Development activities assigned to it under, and in accordance with, such Preclinical Development Plan.

  • Following the Effective Date and at all times during the Term (except with respect to Preclinical Development and clinical activities conducted by each Party pursuant to the Preclinical Development Plan and EGFR Initial Development Plan, and except as set forth in clauses (a) and (b) below), Amgen shall be responsible for, and shall bear all costs associated with, the development, manufacture and commercialization of EGFR Products, including development, distribution, marketing and sales activities.

  • On a Program-by-Program basis, during the applicable Preclinical Development Term, Kite hereby grants to Amgen a non-exclusive, worldwide, royalty-free right under Kite IP solely to conduct Preclinical Development as contemplated under the applicable Preclinical Development Plan.

  • CPC may engage in activities reasonably related to efforts to out-license or sell Unfunded Existing Patents and Know-How specifically related to Unfunded Exiting Patents, provided that such activities do not impair its ability to, or the availability of its personnel to, perform the Preclinical Development Plan or the CTLA-4 Program or otherwise conflict with its obligations hereunder.

  • During the applicable Preclinical Development Term, each Party shall use its reasonable efforts to conduct its Preclinical Development activities of the corresponding Product in accordance with the corresponding Preclinical Development Plan.


More Definitions of Preclinical Development Plan

Preclinical Development Plan means a plan for Preclinical Development of one or more Preclinical Candidates as approved by the Research Committee and the Steering Committee for a Collaboration Project. The Preclinical Development Plan will include a detailed description of the specific responsibilities of each party for various Preclinical Development activities and a proposed timetable for accomplishment of certain objectives for the Collaboration Project.
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Preclinical Development Plan means, the comprehensive plan, overall strategy and timelines, and any updates thereto, for the Preclinical Development of Products directed against the applicable Collaboration Target for a Program, including a description of the Preclinical Development activities; expected timelines; preclinical, manufacturing, regulatory, as well as product risk assessment planned activities; the Format for such Products; and issuance of the Final Report by CytomX to Amgen. The Preclinical Development Plan shall include, but not be limited to, a reasonably detailed description of the schedule of work activity and the responsibility therefor. As the circumstances may require, the JSC may propose from time to time amendments to the Preclinical Development Plan. For each Collaboration Target, the initial Preclinical Development Plan is as set forth on Exhibit C-2.
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Related to Preclinical Development Plan

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

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Program means the implementation of the development plan.

  • Development Activities means those activities which have been approved for the Project as set out in the approved Plans and Specifications and, generally, activities that are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes and include the acquisition of property;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Development Phase means the period before a vehicle type is type approved.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • 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.