definiens: means a controlled or uncontrolled human Clinical Trial of a Licensed Product that would satisfy the requirements of 21 CFR 312.21(c ) or corresponding f oreign regulations, regardless of whether such trial is re ferred to as a that is in tended ( as of the time the Clinical Trial is initiated ) to obtain suf ficient data and results to support the filing of a n application for Regulatory Approval ( but may not include the data t hat may be necessary to support the pricing and/or reimbursement approvals ) . A Phase 3 Registrational Clinical Trial includes any Clinical Trial that sat isfies at least one of the following criteria : ( a ) It would, based on interactions with a Re gulatory Authority or otherwise prior to the initiation of such trial, satisfy the requirements of 21 CFR 312.21(c ) or corresponding foreign regula tions ; ( b ) It is designed in a manner to allow for t he addition of patients such that it could satisfy the requirements of 21 CFR 312.21(c ) or cor responding foreign regulations, provided that such Clinical Trial would only be deemed a Phase 3 Registrational Clinical Trial upon dosing the first patient among such additional patients ; or ( c ) It is otherwise intended, at the time of initiation, to support ( either alone or together with another Phase 3 Registrational Clinical Trial ) an application for marketing approval of a new pro duct ( or an indication or intended use for an already approv ed product )