definiens: shall mean a first formulation comprisingmethoxyamine ( or a methoxyamine derivative ) and an additional formulation(s ) ( to be administered inconjunction with the first formulation, albeit not necessarily simultaneously ) falling within the definition ofLicensed Technology, comprising one or more therapeutic compounds distinct from methoxyamine ( or amethoxyamine derivative ) administered to a Subject 1.6 The term shall mean the date on which the Food & DrugAdministration and the Licensee agree that sufficient data and information have been submitted to theFDA to permit the initiation of a Phase III Clinical Trial of a Licensed Product(s ) without requiring theconduct of further Clinical Trials or the submission of additional data or information as evidenced by thedate on which the FDA and the Licensee complete an End - of - Phase 2 Meeting as defined by 21 CFR312.47(b )