ÀÖÌìÌÃappÏÂÔØ

Initial Phase I Clinical Trials definition

Initial Phase I Clinical TrialsÌýshall include the PRC Phase I Dose Escalation Clinical Trial, the Ex-PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Expansion Cohort Clinical Trial.
Source 1Source 2Source 3

Examples of Initial Phase I Clinical Trials in a sentence

  • Licensor will be solely responsible for supplying Collaboration Compounds and/or finished Products necessary for the conduct of the Initial Phase I Clinical Trials conducted by Licensor.

  • Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in or outside the Territory necessary for the conduct of the Development Program in the Territory other than Initial Phase I Clinical Trials.

  • Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products necessary for the Development Program or for the Commercialization of Products outside the Territory and for Initial Phase I Clinical Trials conducted by Licensor.

  • Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials.

  • Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in the Reserved Territory and for the Initial Phase I Clinical Trials.

Related to Initial Phase I Clinical Trials

  • Phase I Clinical Trial means a human clinical trial in any country that is intended to collect data on safety of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy the requirements of 21 Code of Federal Regulations (“CFRâ€�) §312.21(a) (U.S.) or its non-U.S. equivalent.

  • 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 2 Clinical Trial means a Clinical Trial of a Product that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase 1 Clinical Trial(s) 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. For purposes of this Agreement, ‘initiationâ€� of a Phase 2 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 2 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 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, ‘initiationâ€� 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.