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.

  • 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.

  • 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.

  • 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.

  • During the period in which Edison conducts the Initial Clinical Trial, if any Regulatory Authority takes or gives notice of its intent to take any Regulatory Action with respect to any activity of a Party or its Affiliates, sublicensees (in case of Apollomics) or its subcontractors relating to any Licensed Drug Substance and/or Licensed Product, then such Party shall notify the other Party of such notice or action within [ ] thereof.

  • Partner shall establish and maintain a Clinical Trials master file for each Partner-Conducted Clinical Trial in the format as agreed upon by the JDC (each, a “Clinical Trials Master File”), and the Clinical Trials Master File for the Partner-Conducted Initial Clinical Trial shall be established promptly following the Effective Date.

  • With respect to each Initial Clinical Trial, and any subsequent Clinical Trial for which a Party engages a CRO, the other Party will have the right to review and approve all clinical trial agreement templates, confidential disclosure agreement templates and any other site-facing templates used by the applicable CRO in contracting with clinical trial sites, and any modifications or updates thereto, as well as any revisions thereto proposed by the applicable clinical trial sites.

  • The Deposit for the Initial Clinical Trial (“ICT Deposit”) is estimated to be $55,000 and will be refined by SMIG during Phase A.

  • Finished Product supplied by Company for Development use in the Partner-Conducted Initial Clinical Trial will be supplied at a total cost of two thousand five hundred dollars ($2,500) per subject (including any VAT, if applicable), regardless of whether such subject is dosed with the Initial Product or placebo.

  • Partner, in consultation with Company, shall be responsible for preparing the data management plan (the “ Data Management Plan”) for the Partner- Conducted Clinical Trials, and the Data Management Plan for the Partner-Conducted Initial Clinical Trial shall be submitted to the JDC for its review and approval promptly following the Effective Date.


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 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 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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 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, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

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

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • 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 study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.