definiens: means a Clinical Trial that generally provides for the ﬁrst introduction intohumans of a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokineticproperties and clinical pharmacology of such product, in a manner that is generally consistent with 21 CFR § 312.21(a ), asamended ( or its successor regulation ), provided, however, a Phase I Clinical Trial does not include any study generallycharacterized by the FDA as an in CDER ’s Guidance for Industry, Investigators, and ReviewersExploratory IND Studies, January 2006, irrespective of whether or not such study is actually performed in the United Statesor under an IND . A so - called Phase I / II Clinical Trial shall be deemed to be a Phase I Clinical Trial unless such trial, whencompleted, allows [COMPANY] to proceed directly to a Phase III Clinical Trial