Target Validation Program Term definition

Target Validation Program Term means the term of the Target Validation Program any extensions thereof.
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Examples of Target Validation Program Term in a sentence

  • The drug discovery Target Validation Program shall commence on the Effective Date and be conducted by Lilly and Isis during the Target Validation Program Term in accordance with the Collaborative Research Plan.

  • Prior to the close of the Collaboration Term, Lilly shall have the option to extend each or all of the Reagent Provision Program Term, Target Validation Program Term, and/or the Drug Discovery Program Term for two (2) consecutive two year periods provided that Lilly gives notice to Isis at least nine (9) months prior to the expiration of the Collaboration Term or any extension period of the Reagent Provision Program Term, Target Validation Program Term, and/or the Drug Discovery Program Term.

  • Lilly may exercise an option granted pursuant to this Section 8.2.2 with respect to (i) any Reagent Target during the [***] year period commencing upon delivery to Lilly of a Reagent ASO Compound directed to such Reagent Target and (ii) any Validation Target during the Target Validation Program Term and [***] year thereafter, in each case, by providing written notice to Isis that includes a description of such Reagent Target or Validation Target, as applicable.

  • However, Lilly and Isis shall begin discussions concerning the expiration or extension of Collaboration at least twelve (12) months prior to the end of the Collaboration Term or any extension period of the Reagent Provision Program Term, Target Validation Program Term, and/or the Drug Discovery Program Term.

  • The Target Validation Program Term shall become effective on the Effective Date and shall continue in effect for four (4) years, unless Lilly exercises it option to extend the Target Validation Program Term, as provided in Section 13.1, the Parties otherwise mutually agree to extend or terminate the Target Validation Program, or the Collaboration is terminated in accordance with Article 13.

  • During the Reagent Provision Term or the Target Validation Program Term, as applicable, Lilly may elect to designate any Reagent Target or Validation Target, respectively, an "Exclusive Target" as described in this Section 5.8. Lilly shall provide Isis with a written description of each Target that Lilly desires to designate as an Exclusive Target.

  • During the Reagent Provision Term or the Target Validation Program Term, as applicable, Lilly may elect to designate any Reagent Target or Validation Target, respectively, an "EXCLUSIVE TARGET" as described in this Section 5.8. Lilly shall provide Isis with a written description of each Target that Lilly desires to designate as an Exclusive Target.

  • Lilly may exercise an option granted pursuant to this Section 8.2.2 with respect to (i) any Reagent Target during the [*] year period commencing upon delivery to Lilly of a Reagent ASO Compound directed to such Reagent Target and (ii) any Validation Target during the Target Validation Program Term and [*] year thereafter, in each case, by providing written notice to Isis that includes a description of such Reagent Target or Validation Target, as applicable.

  • During the Target Validation Program Term Lilly may elect to designate any Validation Target, respectively, an “Exclusive Target” as described in this Section 5.8. Lilly shall provide Isis with a written description of each Target that Lilly desires to designate as an Exclusive Target.

  • However, Lilly and Isis shall begin discussions concerning the expiration or extension of Collaboration at least twelve(12) months prior to the end of the Collaboration Term or any extension period of the Reagent Provision Program Term, Target Validation Program Term, and/or the Drug Discovery Program Term.

Related to Target Validation Program Term

  • 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.

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

  • Development Program means the implementation of the development plan.

  • 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.

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

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

  • 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.

  • 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 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).

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

  • 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)).

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • 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.

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

  • Collaboration Term has the meaning set forth in Section 2.1(h).

  • 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 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.

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

  • 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 [***].

  • 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.

  • 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 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.

  • 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).

  • 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;

  • 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.