definiens: means an individual, separate and distinct disease or clinical condition with respect to which at least oneadequate and well controlled study is required to support inclusion of such disease or condition in the indicationstatement of a Regulatory Authority approved package insert for a Product . The Parties agree that : ( i ) prevention of adisease or medical condition shall not be a separate indication from treatment of the same disease or medical condition;(ii ) the treatment and prevention of separate varieties of the same disease or medical condition shall not be a separateindication ; and ( iii ) the treatment or prevention of the same disease or medical condition in a different population shallnot be a separate indication ( e.g., adult and pediatric ) unless in each of ( i)-(iii ) above, at least one adequate and wellcontrolled study is required to support inclusion of such disease or condition in the indication statement of a RegulatoryAuthority approved package insert for a Product . Furthermore, a label enhancement or elaboration or expansion of anapproved Indication is not a separate Indication even if one or more studies are performed to receive such enhancementor elaboration