definiens: means a separate and distinct type of immunological or other disease or medicalcondition in humans and animals : ( a ) which a Licensed Compound or Licensed Product is intended to treat, prevent ordiagnose as evidenced by a clinical trial ; or ( b ) for which a Licensed Compound or Licensed Product has received RegulatoryApproval, meaning that such Indication is contained in the Licensed Product ’s labeling approved by a Regulatory Authorityas part of the Regulatory Approval for such Licensed Product . The Parties agree that : ( i ) prevention of a disease or medicalcondition shall not be a separate indication from treatment of the same disease or medical condition ; ( ii ) the treatment andprevention of separate varieties of the same disease or medical condition shall not be a separate indication ; and ( iii ) thetreatment or prevention of the same disease or medical condition in a different population shall not be a separate indication(e.g