Target Research Plan definition

Target Research Plan has the definition set forth in Section 3.4.1 (Target Research Plans).
Target Research Plan has the meaning set forth in Section 4.2(a).

Examples of Target Research Plan in a sentence

  • During the Research Term for the Target Research Activities and in accordance with the terms and conditions of this Agreement, the Parties will collaborate to identify and synthesize Candidates that Modulate each Target according to the applicable Target Research Plan for such Target, with the aim of identifying IND-ready Candidates for treatment of the corresponding Indication for such Target.

  • Each MAP Target Research Plan approved by the Committee shall be deemed to be part of the Research Plan, and shall be attached as a separate schedule thereto.

  • In the event of any inconsistency between an Option Target Research Plan and this Agreement, the terms of this Agreement will prevail.

  • On an Option Target-by-Option Target basis, Surface will be responsible for performing Research of Option Target Antibody Candidates in accordance with this Agreement and the Option Target Research Plan for the applicable Option Target during the Research Term (each an “Option Target Research Program”).

  • In consideration for AVEO’s research and development activities pursuant to each MAP Target Research Plan that is approved by the Committee in accordance with Section 2.4.1, MERCK shall pay AVEO at the rate of [**] Dollars (US$[**]) per AVEO FTE.

  • Subject to the oversight of the JSC or JMC, as applicable, HMI will be responsible for Manufacturing: (a) Candidates for each Target for Research Activities in accordance with the applicable Target Research Plan; and (b) subject to Sections 8.1.3 (Objective Criteria) and 8.6.1 (Manufacturing Related Rights), Candidates and Products in accordance with the Development Supply Agreement(s), Commercial Supply Agreement(s), and applicable Quality Agreements, as applicable.

  • Subject to the JSC’s review and approval of each Research Plan, the Parties will [***] perform (themselves or through their Affiliates or any subcontractor) the Target Research Activities in accordance with the applicable Target Research Plan and the Exploratory Research Activities in accordance with the Exploratory Research Plan.

  • Within thirty (30) days after the Committee’s approval of the MAP Target Research Plan for each MAP Nominated Target, MERCK shall pay AVEO a technology access fee of [**] Dollars (US $[**]) (the “MAP Technology Access Fee”).

  • Surface will keep the JRC informed regarding the progress of Research activities for the Option Target Research Programs during the Research Term, including a review of results and progress against timelines in the applicable Option Target Research Plan on a [***] basis.

  • The Reserved Target Research Plan shall include an overview of the studies and key data sets which should be included in the Reserved Target Data Package.

Related to Target Research Plan

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

  • Research Program has the meaning set forth in Section 3.1.

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

  • 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 Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

  • Research Budget has the meaning set forth in Section 2.2.

  • 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.

  • Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.

  • 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 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.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • 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;

  • Collaboration has the meaning set forth in Section 2.1.

  • 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 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.

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

  • 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.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Research-based means a program or practice that has some research demonstrating effectiveness, but that does not yet meet the standard of evidence-based practices.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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.

  • 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.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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.

  • Research Term has the meaning set forth in Section 3.2.