Triggering Clinical Trial definition

Triggering Clinical Trial means for each Galapagos Program either:
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Triggering Clinical Trial means, for an Optioned Molecule in an Optioned GLP Initial New Target Program for an Initial New Target, the Clinical Trial(s) for such Optioned Molecule that are consistent with the TCT Criteria for the applicable Initial New Target as set forth in Section 8.3(b)(vii)(A). [***].”
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Triggering Clinical Trial means, for an Arcus Molecule:
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Examples of Triggering Clinical Trial in a sentence

  • If such dispute is regarding whether a Clinical Trial constitutes a Triggering Clinical Trial or whether or when a Qualifying Data Package has been delivered, in each case, for any Galapagos Program, then either Party may refer such dispute to the Parties’ Subject Matter Experts for Development after the […***…] Business Day after a Party requests a meeting of the JSC to make such a determination.

  • Without limitation to the foregoing, with respect to each Galapagos Program, the JSC shall determine whether a Clinical Trial constitutes a Triggering Clinical Trial and whether and when a Qualifying Data Package has been delivered, in each case, for such Galapagos Program as further described in Sections 2.3(c) and 2.3(d).

  • With respect to each Selected Target, Arcus shall use commercially reasonable efforts to conduct Arcus R&D Activities with respect to such Selected Target from the prompt initiation of Pre-Program Activities, through the establishment of an Arcus Program Directed To such Selected Target and the Completion Date of the Triggering Clinical Trial with respect to such Arcus Program.

  • For clarity, a Triggering Clinical Trial with respect to an Arcus Combination shall be deemed a Triggering Clinical Trial for the Arcus Program with respect to the applicable Arcus Molecule included in such Arcus Combination.

  • With respect to each Optioned Program for which the Triggering Clinical Trial is a Phase 3 Clinical Trial, if such Triggering Clinical Trial has reached its Completion Date, then Gilead shall pay to Galapagos an amount equal to the sum of (i) […***…] percent […***…] of the costs and expenses Gilead would have borne had such Triggering Clinical Trial been included in an R&D Plan and Budget and (ii) […***…].

  • Once a Clinical Trial is approved by the JDC as a Triggering Clinical Trial, then, no later than [***] days after the applicable Completion Date for such Clinical Trial, Assembly shall deliver to Gilead a written notice including instructions and credentials with which Gilead may access a Data Room containing the data and information required to be included in a Qualifying Data Package with respect to the Assembly Program that includes such Triggering Clinical Trial.


More Definitions of Triggering Clinical Trial

Triggering Clinical Trial means, for an Assembly Molecule:
Sample 1

Related to Triggering Clinical Trial

  • 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.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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 BMS and that otherwise fit the foregoing definition.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

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

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;