definiens: . Clinical Study means ( i ) a human clinical study in any country that is intended to initially evaluate the safetyor pharmacological effect of an Antibody Product in subjects or that would otherwise satisfy requirements of21 C.F.R. 312.21(a ), or its 4 equivalent outside the United States ( a Phase I Clinical Study ), ( ii ) a human clinical study in any countrythat is intended to initially evaluate the effectiveness of an Antibody Product for a particular indication orindications in patients with the disease or indication under study or that would otherwise satisfy requirementsof 21 C.F.R. 312.21(b ), or its equivalent outside the United States ( a Phase II Clinical Study ), ( iii ) a pivotalhuman clinical study, the principal purpose of which is to establish safety and efficacy in patients with thedisease target being studied as required in 21 C.F.R. 312, or similar clinical studies prescribed by theRegulatory Authorities in a country other than the United States whether or not such study is a traditionalPhase III study ( a Phase III Clinical Study ) or ( iv ) a human clinical study that is required or requested by aRegulatory Authority as a condition of or in connection with obtaining or maintaining a Regulatory Approval(whether commenced prior to or after receipt of such Regulatory Approval ) ( a Phase IV Clinical Study )