Initial Clinical Trial definition

Initial Clinical Trial means the initial clinical trial of Licensed Product as referred to in Exhibit F.
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Initial Clinical Trial means a human clinical trial of a Product (as required by the applicable Regulatory Authority) conducted to generate pharmacokinetic and pharmacodynamic (if relevant pharmacodynamic measures exist) data that is comparative to the applicable Reference Product, for purposes of supporting an application for Regulatory Approval under Section 351(k) of the PHS Act, or equivalent in other countries within the Territory. The Initial Clinical Trial shall be designed to be a Phase 1 clinical trial for such Product but may also include additional features that could facilitate a waiver or targeting of the Additional Clinical Trial.
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Initial Clinical Trial means a human clinical trial of the Product (as required by the applicable Regulatory Authority) conducted to generate pharmacokinetic and (if relevant pharmacodynamic measures exist) pharmacodynamic data that the Product is comparable to the applicable Reference Product, for purposes of supporting an application for Marketing Authorization under the BPCI Act, or equivalent approval process in other countries within the Territory.
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Examples of Initial Clinical Trial in a sentence

  • The Parties further agree that the Development Program consists of the development plan attached hereto as Exhibit F (the "Development Plan"), which includes, among other items, the primate efficacy study and large animal study described therein and the Initial Clinical Trial.

  • With respect to each Clinical Trial other than an Initial Clinical Trial, the JDC will determine the roles and responsibilities of the Parties’ respective Physician Leads and Clinical Operations Study Leads.

  • In addition, prior to the commencement of each Initial Clinical Trial, each Party will obtain and provide to the other Party for review a copy of each clinical trial site’s insurance policy with respect to such Initial Clinical Trial.

  • At the earlier of the end of the term of the Development Program or the completion of the Initial Clinical Trial, Genentech will decide whether to continue the Development Program, proceed to the Clinical Development Program, or terminate the program, all as provided in Section 4.05.

  • The Parties agree that the "Clinical Development Program" includes, among other items, all human clinical studies of Licensed Products directed toward approval of a Submission in the United States (after the Initial Clinical Trial), manufacturing scale-up and other work to develop and commercialize Licensed Products.

  • Following such transfer, [***] may elect, subject to the terms hereof, to terminate the [***] Agreement and utilize [***] for the Initial Clinical Trial for beta-thalassemia unless the JDC determines that [***] then-existing internal clinical operations staff (or, if applicable, the clinical operations staff of [***] or the [***] Agreement would [***] will determine in its sole discretion whether the Initial Clinical Trial for sickle cell[***]disease will be conducted under the [***] Agreement or [***].

  • The JSC shall meet within the first [ ] after its formation, then (a) at least [ ] and ad hoc as required until the completion of the Initial Clinical Trial and thereafter at times mutually agreed upon by the Parties.

  • To be revised and updated prior to beginning of Phase B A Company Incorporation Procedure and process report for incorporation (pre- registration) Completion report with copy of all certificates and details (post registration) Frequency: Approximately Week 8 with periodic updates A Identify medical institution(s) to participate in Initial Clinical Trial, potentially including Apollo.

  • Such activities shall include designing and conducting the Initial Clinical Trial, and filing all regulatory materials and interacting with Regulatory Authorities associated with such Initial Clinical Trial.

  • Initially, subject to Section 3.2, Edison shall control and provide the clinical trial supply of the Licensed Drug Substance for use in the Initial Clinical Trial, [ ] .


More Definitions of Initial Clinical Trial

Initial Clinical Trial means a Clinical Trial in India pursuant to this Agreement intended to satisfy the requirements for all approvals necessary to manufacture, license, sell and distribute the GTC Products included in that trial in India, and potentially other countries in the Territory. By U.S. standards, this trial would generally include FDA Clinical Trial Phases 1 and 2, and possibly certain elements of FDA Clinical Trial Phase 3, and is unlikely to satisfy all FDA requirements for Clinical Trials for marketing authorization.
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Initial Clinical Trial means (i) the clinical trial to be conducted pursuant to [ ] or (ii) any other clinical trial conducted to test the safety and/or efficacy of the Licensed Drug Substance in humans.
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Initial Clinical Trial means in respect of a particular Product the first of (i) a Phase I Clinical Trial and (ii) a Phase II Clinical Trial.
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Related to Initial 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 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 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 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 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 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 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 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.

  • 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 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).

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

  • 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:

  • 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.

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

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

  • 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 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).

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • 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;

  • 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.