Early Clinical Development Program definition

Early Clinical Development Program means, as to each Development Candidate, the program of Development activities for such Development Candidate in accordance with the associated Early Clinical Development Plan during the Early Clinical Development Term. For clarity, the Early Clinical Development Program will not include activities conducted under the Research Plan or Late Clinical Development Program or relating to Manufacturing.
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Examples of Early Clinical Development Program in a sentence

  • Except as otherwise expressly provided in this Agreement, all matters regarding the Early Clinical Development Program and the Late Clinical Development Program will be decided by unanimous agreement by the JDC.

  • If the premium paid by the Insured for such "stock" exceeds the actual premium thus calculated, the Insurer shall refund to the Insured any excess paid, subject to a maximum refund of 50% of the premium paid.

Related to Early Clinical Development Program

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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.

  • Development Program means the implementation of the development plan.

  • 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 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.