definiens: means a controlled clinical study, or a portion o f a controlled study, in humans ofthe efficacy and safety of a pharmaceutical product, which study ( in its entirety or portion, as appli cable ), isprospectively designed to demonstrate statistically whether such product is effective and safe for use in a particularOncology Indication in a manner sufficient to file an NDA, MAA or other Regulatory Approval Applicatio n to obtainRegulatory Approval, as further defined in Federal Regulation 21 C.F.R. § 312.21(c ) and its foreign equ ivalents . For thesake of clarity, with respect to what is commonly c alled a phase 2/3 study, the Phase III Study defini tion is met uponthe first patient, first visit in the portion of su ch study that is prospectively designed to demonstr ate statisticallywhether such pharmaceutical product is effective an d safe for use in a particular Oncology Indication in a mannersufficient to file an NDA, MAA or other Regulatory Approval Application to obtain Regulatory Approval, as furtherdefined in Federal Regulation 21 C.F.R. § 312.21(c ) and its foreign equivalents