Initial Trials definition

Initial Trials means the following pair of Clinical Trials of the Initial Product:
Sample 1
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”).
Sample 1
Initial Trials has the meaning set forth in Section 2.1.
Sample 1

Examples of Initial Trials in a sentence

  • 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)”).

  • 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.

  • 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.

  • 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.

  • 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.

  • These lines will be evaluated further in the ARPT and ARPT Clearfield tests this year along with several other Clearfield lines.Twenty-three extremely early lines from the cross RU9101001/ ‘Raminade Strain 3’ were evaluated in the Stuttgart Initial Trials (SIT) at the Rice Research and Extension Center and the Southeast Research and Extension Center-Rohwer Division during the 2007 growing season.

  • 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.

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

  • If the Parties jointly agree to conduct any further Combined Therapy Trials beyond the Initial Trials, if necessary, the Pharmacovigilance Agreement and the Quality Agreement shall be amended to provide for such Combined Therapy Trial under the terms thereof.

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

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 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 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 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.

  • 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.

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

  • 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 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.

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

  • 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 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 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 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).

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

  • 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.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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.

  • 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:

  • 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).

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

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

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Interconnection Studies means the Interconnection Feasibility Study, the System Impact Study, and the Facilities Study described in Tariff, Part IV and Tariff, Part VI.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following: