Human Clinical Trials definition

Human Clinical Trials is defined in Article 13.2;
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Human Clinical Trials means any Product or Licensee Owned Improvement Product testing involving human subjects;
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Human Clinical Trials means any clinical Product testing involving human subjects;
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Examples of Human Clinical Trials in a sentence

  • The Licensee shall provide the University with certificates of insurance evidencing such coverage 30 days before commencement of Human Clinical Trials and 30 days prior to the sales of any Product and the Licensee covenants not to start Human Clinical Trials, or sell any Product before such certificate is provided and approved by the University, or to sell any Product at any time unless the insurance outlined in this Article 13.2 is in effect.

  • The Licensee will provide to UBC for its approval certificates of insurance evidencing the coverage 7 days before the earlier of any Human Clinical Trials or the First Commercial Use.

  • With respect to each and every Licensed Product, CBC shall supply one hundred percent (100%) of Adjuvant Requirements prior to Commercial Introduction of such Licensed Product, including for purposes of all research and development, pre-clinical trials and human clinical trials (including PLA-Enabling Human Clinical Trials) of such Licensed Product.

  • The Licensee will provide to UBC for its approval certificates of insurance evidencing the coverage seven days before the earlier of any Human Clinical Trials.

  • The Licensee will provide to UBC for its approval certificates of insurance evidencing the coverage seven days before the earlier of any Human Clinical Trials or the First Use of the Technology.

  • The Company will provide to UBC for its approval certificates of insurance evidencing the coverage 7 days before the earlier of any Human Clinical Trials or the First Commercial Use.

  • Without limiting the generality of the forgoing, no Payor or any of it Related Parties will: (x) start any Human Clinical Trials, or (y) sell any Licensed Product; at any time unless an insurance certificate is provided to UBC, and the insurance outlined above is in effect.

  • The Licensee shall provide the University with certificates of insurance evidencing such coverage thirty (30) days before commencement of Human Clinical Trials and thirty (30) days prior to the sales of any Product and the Licensee covenants not to start Human Clinical Trials, or sell any Product before such certificate is provided and approved by the University, or to sell any Product at any time unless the insurance outlined in this Article 13.2 is in effect.

  • Milestone: Manufacture, fill & finish Ii-Key-SARS-CoV-2 Peptide Vaccine to meet standards of the NMPA for Phase I and Phase II human clinic studies Task 5: Phase I and Phase II Human Clinical Trials (China and the U.S. proceed simultaneously) Early stage clinical trials to evaluate the safety and dose of the final Ii-Key­SARS-Co V-2 Peptide Vaccine in health adults (18 - 55 years old).

  • Each Payor will provide to UBC certificates of insurance evidencing the coverage [**] days before the start of any Human Clinical Trials.


More Definitions of Human Clinical Trials

Human Clinical Trials shall have the meaning set forth in Section 12.1(a).
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Related to Human 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 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.

  • 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 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.