Initial Trials definition

Initial Trials means the following pair of Clinical Trials of the Initial Product: (a) A Phase 2 Clinical Trial in Crohn’s disease, as described in the attached Clinical Development Plan; and (b) The first cohort of two hundred forty (240) subjects in the Phase 2/3 Clinical Trial in Ulcerative Colitis, as described in the attached Clinical Development Plan (“Phase 2/3 UC Trial”).
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Initial Trials has the meaning set forth in Section 2.1.
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Initial Trials means the following pair of Clinical Trials of the Initial Product:
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Examples of Initial Trials in a sentence

  • During the Research Term, Amerimmune and Histogen agree to cooperate with regard to submitting grant applications or the like to Third Party funding agencies in order to obtain financial support for the Research Program, including the conduct of the Initial Trials and such additional Clinical Trials as the Parties mutually agree to undertake.

  • In the event Exelixis and BMS decide to conduct further Combined Therapy Trials beyond the Initial Trials as set forth in Section 5.4 of the Agreement, Exelixis shall ensure that Ipsen is granted access to any data arising from such additional Combined Therapy Trials, subject to Ipsen agreeing to amend the Global Development Plan of the Ipsen-Exelixis Agreement to include such additional Combined Therapy Trials and the Protocol for such Trials.

  • To facilitate conduct of the Research Program beyond the conduct of the Initial Trials, if available and promptly following a written request from Amerimmune, Histogen shall provide Amerimmune with reasonable quantities of clinical Emricasan for the conduct of such additional Clinical Trials as the JDC approves.

  • Promptly following completion of the Initial Trials, Theravance shall provide ▇▇▇▇▇▇▇ with the Triggering Data Package After Phase 2.

  • Ipsen and Exelixis have agreed to the division of responsibilities for the Initial Trials, including but not limited to BMS’ right to be the Conducting Party and holder of the Combined Therapy IND for the RCC and HCC studies, as identified in Exhibit A to the Agreement.

  • To facilitate conduct of the Initial Trials, after the Effective Date and promptly following a written request from Amerimmune, Histogen shall provide Amerimmune (or clinical trial sites designated by Amerimmune), at no cost to Amerimmune, with reasonable quantities of clinical Emricasan to conduct the Initial Trials, subject to the availability of Emricasan to Histogen.

  • Upon the conclusion of any Clinical Trial conducted pursuant to the Research Program, including the Initial Trials, Amerimmune shall promptly prepare and submit to the JDC for review and approval a final report detailing the conduct of and the Trial Results obtained, and conclusions drawn, from such Clinical Trial, including the Initial Trials (as relates to either of the Initial Trials, the “Initial Trial Report(s)”).

  • Amerimmune, in collaboration with Histogen, shall prepare and submit to the JDC for approval a Development Plan for the Initial Trials.

  • During the Research Program and until such time as a Strategic Partner assumes responsibility pursuant to a Qualifying Strategic Partnership, Histogen, in collaboration with Amerimmune, shall be responsible for and shall control all Regulatory Interactions relating to any Phase I or Phase II Study of Emricasan conducted pursuant to the Research Program, including the Initial Trials.

  • Theravance shall be responsible, at its cost, for the Manufacturing and supply of all Products and Compound API required for the Initial Trials of the Initial Product and the Pre-Opt-In Phase 3 Activities initiated pursuant to the Collaboration Plans during the Opt-In Period, in accordance with the Collaboration Plans; provided that the costs of Manufacturing Product for the Pre-Opt-In Phase 3 Activities will be subject to Section 6.3(a).

Related to Initial Trials

  • 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 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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 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.