Phase IIB Clinical Trial

Phase IIB Clinical Trial. As to a specific Licensed Product, a study in humans of such product, designed to generate sufficient data to commence (if successful) a Phase III Clinical Trial, as further defined in 21 C.F.R. § 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase IIB Clinical Trial shall be deemed initiated upon the first dosing of the first research subject.