Phase I Clinical Trial

Phase I Clinical Trial. As to a particular product for a particular indication, the initial study in humans of the safety of such product for such indication, which is prospectively designed to generate data to support commencing a Phase II Clinical Trial (as defined in the License Option Agreement) of such product for such indication.

Phase I Clinical Trial. A human clinical trial in any country that is intended to initially evaluate the of a product in subjects or that would otherwise satisfy the requirements of 21 CFR 312.21(a) or its foreign equivalent

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

Phase I Clinical Trial. The term "Phase I 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 healthy human patients to generate sufficient data to establish the safety and biological activity of that Product, and to permit commencement of a Phase II Clinical Trial.

Phase I Clinical Trial. The term "Phase I Clinical Trial" means a human clinical trial for any Product in any country that would satisfy the requirements of 21 CFR 312.21(a).

Phase I Clinical Trial. Any human clinical trial, conducted by or on behalf of Licensee, any of its Affiliates, or a Sublicensee with respect to a Covered Product, including typically the first phase of clinical trials conducted in relatively small numbers of healthy volunteers or patients with the targeted condition to obtain information on a Covered Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as more fully defined in 21 C.F.R. § 312.21(a), as... may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction. View More

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

Phase I Clinical Trial. As to a specific Licensed Product, a study in humans of such product designed to satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase I Clinical Trial shall be deemed initiated upon the first dosing of the first research subject.

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

Phase I Clinical Trial. A controlled clinical study of the first introduction of the LICENSED PRODUCT into human subjects.