definiens: means a Clinical Trial in which the Licensed Product is administered to human subjectsat single and multiple dose levels with the primary purpose of determining safety, metabolism, andpharmacokinetic and pharmacodynamic properties of the Licensed Product, and which is consistentwith 21 U.S. CFR § 312.21(a ), or, with respect to any other country or jurisdiction, the equivalent ofsuch a Clinical Trial in such other country or jurisdiction . For the purposes of the milestone payments inSection 8.2, a shall be a Clinical Trial, which is submitted by CASI to the RegulatoryAuthority as a Phase I Trial or as a phase I / II Clinical Trial.141.96 means a Clinical Trial of the Licensed Product in human patients, the principalpurposes of which are to make a preliminary determination that the Licensed Product is safe for itsintended use, to determine its optimal dose, and to obtain suﬃcient information about the LicensedProduct ’s eﬃcacy to permit the design of Phase III Trials, and which is consistent with 21 U.S. CFR § 312.21(b ), or, with respect to any other country or jurisdiction, the equivalent of such a Clinical Trial insuch other country or jurisdiction