definiens: means a controlled c linical study, or a portion of a controlled study, in humans of the efficacy and safety of a Licensed Pro duct, which study ( in its entirety or portion, as a pplicable ), is prospectively designed to demonstrate statistically whether such Licensed Product is effective and saf e for use in a particular indication in a manner sufficient to fil e a Regulatory Approval Application to obtain Regul atory Approval, as further defined in federal regulation 21 C.F.R. § 312.21(c ) or its foreign equivalents . F or clarity, with respect to what is commonly called a phase 2/3 stud y, the Phase III Clinical Study definition is met u pon the first patient, first visit in the portion of such study t hat is prospectively designed to demonstrate statis tically whether such Licensed Product is effective and safe for use in a particular indication in a manner sufficient to file a Regulatory Approval Application to obtain Regulator y Approval, as further defined in federal regulatio n 21 C.F.R