definiens: shall mean human clinical trials, the principal purpose of which is to establish safety andefficacy of one or more particular doses in patients with the Indication being studied as required in 21 C.F.R. § 312.21,or similar clinical study in a country -6- [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted andfiled separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of1933, as amended . CONFIDENTIAL EXECUTION COPY other than the United States . For purposes of this Section 1.55, and Sections 1.53 and 1.54 above, a particular trialthat ( i ) is intended to overlap two phases of trials, ( ii ) combines the elements of two phases of trials, or ( iii ) is treatedby the FDA or comparable foreign agency as two phases of trials, such as a Phase I / II trial or a Phase II / III trial, shallbe deemed a trial of the later, as well as the earlier, phase ( i.e