Registration-Enabling Phase II Trial definition
Registration-Enabling Phase II Trial means a Phase II Trial of the Licensed Product that (a) would, based on interactions with a Regulatory Authority or otherwise, (1) satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations or (2) is designed in a manner to allow for the addition of additional patients such that 14 it could satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations; or (b) is otherwise intended to support (either alone or together with one or more additional Phase III Trials) an application for Regulatory Approval of the Licensed Product (or a new Indication or expanded use if the Licensed Product has already been approved).