Target Discovery Program definition

Target Discovery Program has the meaning specified in Section 2.1.1 hereof.
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Target Discovery Program has the meaning set forth in Section 2.1.
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Examples of Target Discovery Program in a sentence

  • The Target Discovery Program Term shall continue until such work is complete.

  • Without limiting the foregoing, subject to the rights and licenses granted under this Agreement, Lexicon shall own and retain all rights to (a) all Mutant Mice and progeny thereof and any cells or other materials derived by Lexicon therefrom and (b) any invention or discovery that is conceived or first reduced to practice by Lexicon or any of its Affiliates during the course of any analysis of Mutant Mice performed in the Target Discovery Program.

  • For clarification, the number of FTEs referenced in the previous sentence shall not include Lexicon FTEs working on the Target Discovery Program, except as set forth in Section 2.2.5. Each party agrees in good faith to expedite the hiring and utility of such FTEs as early in the applicable Contract Year as possible.

  • The JSC will be responsible for the overall oversight of the Target Discovery Program, Target Validation Programs and Compound Discovery Programs.

  • Except as otherwise provided in this Agreement, the Parties will make available and disclose to one another all material Results generated pursuant to the Target Discovery Program, a Target Validation Program or a Compound Discovery Program prior to and in preparation for the JSC or applicable subcommittee meetings, by the deadline and in the form and format to be designated by the JSC or applicable subcommittee.

  • All lines of Mutant Mice developed by Lexicon prior to the Effective Date (including but not limited to those for which Xxxxx 0 Xxxxxxxxxx Xxxxxxxx xxx/xx Xxxxx 0 Xxxxxxxxxx Analysis was completed prior to the Effective Date), with the exception of LG617, shall be included in the Target Discovery Program.

  • In support of the Research Program, Lexicon will continue its efforts, using its technology for the generation and analysis of the phenotypes of Mutant Mice, to identify and validate Targets with potential utility in the CNS Field (the "Target Discovery Program").

  • The initial Target Discovery Plan is attached hereto as Schedule 3.2.1. Any Oncology Targets identified during the Target Discovery Program shall be documented in a list so that the Parties may track, through the JSC, which Oncology Targets are actively being pursued by the Parties or have been determined by the JSC to be abandoned (the “Oncology Target List”).

  • Millennium is not a party to any contract that, if terminated, would materially adversely affect Millennium's ability to conduct the Target Discovery Program in accordance with the Research Plan.

  • During the Research Term, either Party may propose amendments to the Target Discovery Plan in writing to the JSC, which shall become effective upon approval by the JSC in accordance with Section 2.6. Each Party shall be responsible for its own Target Discovery Program costs.

Related to Target Discovery Program

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Third Target Distribution means $0.5250 per Unit per Quarter (or, with respect to the period commencing on the Closing Date and ending on September 30, 2005, it means the product of $0.5250 multiplied by a fraction of which the numerator is equal to the number of days in such period and of which the denominator is 92), subject to adjustment in accordance with Section 6.6 and Section 6.9.

  • 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.

  • Second Target Distribution means $0.4375 per Unit per Quarter (or, with respect to the period commencing on the Closing Date and ending on September 30, 2005, it means the product of $0.4375 multiplied by a fraction of which the numerator is equal to the number of days in such period and of which the denominator is 92), subject to adjustment in accordance with Section 6.6 and Section 6.9.

  • Development Milestone is defined in Section 5.3.

  • First Target Distribution means $0.4025 per Unit per Quarter (or, with respect to the period commencing on the Closing Date and ending on September 30, 2005, it means the product of $0.4025 multiplied by a fraction of which the numerator is the number of days in such period, and of which the denominator is 92), subject to adjustment in accordance with Section 6.6 and Section 6.9.

  • 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 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.

  • 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.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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).

  • 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.

  • Milestone Event has the meaning set forth in Section 8.2.1.

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

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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

  • 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.

  • 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.

  • Development Program means the implementation of the development plan.

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

  • 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.

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

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