definiens: means ( a ) in connection with obtaining Regulatory Approval in the United States, aClinical Trial that is conducted in human patients with a defined dose or set of defined doses of the Licensed Product, after successful completion of one or more Phase II Clinical Trials, designed to evaluate safety and therapeuticefficacy of the Licensed Product, to define warnings, precautions and adverse reactions associated with the LicensedProduct in the dosage range to be prescribed, as more fully defined in 21 C.F.R. § 312.21(c ), as may be amended or(b ) in connection with obtaining Regulatory Approval in any other jurisdiction, the equivalent of any such Clinical Trialin such other country or jurisdiction . If the FDA ( or other equivalent regulatory authority ) does not accept such ClinicalTrial under 21 C.F.R. § 312.21(c ) or otherwise advises against referring to such Clinical Trial as a trial, such Clinical Trial shall not be deemed a Phase III Clinical Trial