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 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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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.

  • 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.

  • With respect to any Product other than the Initial Product, the Parties shall agree in writing on the sharing of costs, if any, under the applicable Joint Preclinical Development Plan.

  • Such study shall be added to the Joint Preclinical Development Plan [***].

  • Initiate Preclinical Development Plan for a Licensed Product within three (3) months of the effective date of this Agreement.

  • The Parties shall promptly generate a Preclinical Development Plan for the Program for such Additional Target in accordance with Section 3.4 (Preclinical Development Plan).

  • The Parties shall prepare any such Preclinical Development Plan by modeling it after the Standard Preclinical Development.

  • Trains can be dispatched from either end or from intermediate points on the track.

  • 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.

  • Except as provided in Section 6.2 (Manufacturing Matters) and as provided under a Preclinical Development Plan, Amgen will be solely responsible for the preparation, submission and maintenance of all Regulatory Filings and obtaining all Regulatory Approvals (including any Marketing Approvals) with respect to Amgen Products.


More Definitions of Preclinical Development Plan

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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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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Related to Preclinical Development Plan

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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 Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

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

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Development Program means the implementation of the development plan.

  • 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).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • 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.

  • 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.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.