Phase II Clinical Trial

Phase II Clinical Trial. A human clinical trial conducted in any country that is intended to initially evaluate the effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or indication under study, or that otherwise satisfies the requirements of 21 CFR 312.21(b) or its foreign equivalent.

Phase II Clinical Trial. Means a human clinical trial in any country conducted to evaluate the effectiveness of a therapeutic product, for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine the common short-term side effects and risks associated with the therapeutic product. In the United States, "Phase II Clinical Trial" means a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21 (b).

Phase II Clinical Trial. Any human clinical trial of a Licensed Product conducted for purposes of preliminary determination of efficacy and/or preliminary establishment of appropriate dosage ranges for efficacy and safety in patients, as described under 21 C.F.R. §312.21(b) (as hereafter modified or amended) and any of its foreign equivalents

Phase II Clinical Trial. As to a particular product for a particular indication, the initial controlled and lawful study in humans of the safety, dose ranging and efficacy of such product for such indication, which is prospectively designed to generate data to support commencing a Phase III Clinical Trial of such product for such indication.

Phase II Clinical Trial. Shall have the meaning ascribed by the FDA and as promulgated under 21 C.F.R. § 312.21(b).

Phase II Clinical Trial. The term "Phase II Clinical Trial" shall mean those further and lawful studies of a Product conducted anywhere in the Territory that the applicable Regulatory Authority requires to be performed on a sufficient number of human patients with the condition treated by the Product to generate sufficient data to establish the safety, and biological activity of that Product for its intended use and to permit commencement of a Phase III Clinical Trial.

Phase II Clinical Trial. Means a human clinical trial of a Licensed Product that satisfies the requirements of 21 CFR 312.21(b).

Phase II Clinical Trial. The term "Phase II Clinical Trial" means a human clinical trial conducted in any country that would satisfy the requirements of 21 CFR 312.21(b) and is intended to explore one or more doses, dose response, and duration of effect, and to generate initial evidence of clinical activity and safety, for any Product in the target patient population.

Phase II Clinical Trial. Means a human clinical trial in any country conducted by Company or its Affiliate to initially evaluate the effectiveness of a Licensed Product in human subjects with the disease or indication under study or that would otherwise satisfy the requirements of 21 CFR 312.21(b) or the equivalent laws, rules or regulations in a regulatory jurisdiction outside the United States.

Phase II Clinical Trial. A human clinical trial, in any country, that would satisfy the requirements of 21 C.F.R. 312.21(b).