Triggering Clinical Trial definition

Triggering Clinical Trial means for each Galapagos Program either: (A) the first Phase 2 Clinical Trial that reaches its Completion Date for a Galapagos Product in such Galapagos Program for a particular indication and that satisfies each of the following criteria: (1) […***…]; (2) […***…]; and (3) […***…]; or (B) the first Phase 3 Clinical Trial that reaches its Completion Date for a Galapagos Product in such Galapagos Program, if such Phase 3 Clinical Trial reaches its Completion Date prior to any Phase 2 Clinical Trial for such Galapagos Product in such Galapagos Program that satisfies the criteria in clause (A) above.
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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 Assembly 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 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) […***…].

  • 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.

  • 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 each Galapagos Program either:
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Triggering Clinical Trial means, for an Assembly Molecule: (A) (1) With respect to an Assembly Program (other than the [***]), the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***]; or (2) with respect to the [***], the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***] (each of (1) and (2), a “First Triggering Clinical Trial”), in each case, which Clinical Trial is consistent with the TCT Criteria set forth in the applicable Development Plan; and (B) the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***] (a “Second Triggering Clinical Trial”), in each case, which Clinical Trial is consistent with the TCT Criteria set forth in the applicable Development Plan.
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Triggering Clinical Trial means, for an Arcus Molecule: (A) With respect to an Arcus Program other than an Acquired Arcus Program that constitutes an Arcus Program upon acquisition, except as otherwise specified in clause (B) below, the Clinical Trial(s) sponsored by Arcus and approved by the JSC as the Triggering Clinical Trial for such Arcus Molecule, which Clinical Trial shall be consistent with the TCT Criteria. The “TCT Criteria” are as set forth in Schedule 8.3(b)(vii); (B) With respect to the following Arcus Molecules: [***] (C) With respect to an Acquired Arcus Program that constitutes an Arcus Program upon acquisition, and except as otherwise specified in clause (D) below, the Clinical Trial(s) approved by the JSC as the Triggering Clinical Trial for such Arcus Molecule (whether pursuant to Section 3.3(c)(i)or 3.3(c)(iii)), which Clinical Trial shall be consistent with the TCT Criteria; and (D) With respect to an Acquired Arcus Program that constitutes an Arcus Program upon acquisition and that includes, at the time of acquisition, a [***] Clinical Trial that has reached its Completion Date or an Approved Acquired Product, a Triggering Clinical Trial will be deemed to have occurred as of the closing of the applicable acquisition. provided that with respect to each of clause (A), (B) and (C) above, if the existing Triggering Clinical Trial is halted, then the JSC shall designate a substitute Triggering Clinical Trial for such Arcus Molecule, and; provided, further, that, [***].
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Related to Triggering Clinical Trial

  • 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 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 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.

  • 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 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 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 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.

  • 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 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 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.

  • 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 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.

  • Clinical Trial means any human clinical trial of a Product.

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

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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 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.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • 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.

  • 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;