Phase Ill Clinical Study definition

Phase Ill Clinical Study means a human clinical study of a Licensed Product (regardless of whether actually designated as “Phase III”) that is prospectively designed, along with other Phase Ill Clinical Studies, to demonstrate statistically whether a Licensed Product is safe and effective for use in humans in the indication being investigated as described in 21 C.F.R. §312.21(c), or an equivalent clinical study in a country in the Territory other than the United States.
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Phase Ill Clinical Study means a clinical investigation of a Licensed Product in human patients to establish efficacy and safety and required to file a NDA application of a Licensed Product with Regulatory Authorities.
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Examples of Phase Ill Clinical Study in a sentence

  • The Licensee will provide 100% of the funding to support the clinical development and commercialization of Licensed Compounds, alone and in combination therapy, in the Territory, including, without limitation, funding of the Phase I Clinical Study, the Phase Il Clinical Study and the Phase Ill Clinical Study for the treatment of prostate cancer, which will be conducted in compliance with ICH guidelines.

  • Thereafter, and until the commercial launch of Licensed Products in the Field in the Territory, Licensee agrees to expend a minimum of One Million United States Dollars ($1,000,000 USD) annually to complete the Phase Ill Clinical Study, regulatory submissions, and other product development activities required by the CFDA for regulatory approval and commercialization of the Licensed Products in the Field in the Territory.

  • From the initiation of a Phase Il Clinical Study, and for three (3) years thereafter, Licensee agrees to expend a minimum of Five Hundred Thousand United States Dollars ($500,000 USD) annually toward the clinical development of the Licensed Products in the Field in the Territory, with an understanding that a Phase Ill Clinical Study will be initiated at the end of this 3-year period.

Related to Phase Ill 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 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).

  • 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. [***]

  • 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 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.