definiens: means, as to a specific Licensed Product, a study in humans designed with the principalpurpose of determining initial efficacy and dosing of such Licensed Product in patients for the indication(s ) being studied asdescribed in 21 C.F.R. § 312.21(b ) ; or a similar clinical study in a country other than the United States.***Text Omitted and Filed Separately with the Securities and ExchangeCommission . Confidential Treatment Requested Under17 C.F.R. Sections 200.80(b)(4 ) and 240.24b-2 1.32 means, as to a specific Licensed Product, a lawful study in humans of the efficacy and safetyof such Licensed Product, which is prospectively designed to demonstrate statistically whether such Licensed Product iseffective and safe for use in a particular indication in a manner sufficient to file an application to obtain Marketing Approvalto market and sell that Licensed Product in the United States or another country for the indication being investigated by thestudy, as described in 21 C.F.R. § 312.21(c ) ; or similar clinical study in a country other than the United States