definiens: means an entirely separate and distinct disease o r medical condition in humans which a pharmaceutical or biological product : ( a ) t hat is in Clinical Trials is intended to treat in s uch Clinical Trials ; or ( b ) has received a separate and distinct Regulatory Approval with an approved label claim t o treat such disease or condition, as applicable . For clarity : ( i ) moving from one line of therapy to another withi n an Indication ( e.g., moving from second - line therapy to first - line the rapy ) will not be considered to be a new Indication ; ( ii ) a single Indication would include the primary disease and all variants or sub - divisio ns or sub - classifications within such primary disease, and re gardless of prophylactic or therapeutic use, pediat ric or adult use and 15 irrespective of different formulation(s ), dosage fo rms, dosage strengths or delivery system(s ) used ; ( iii ) initiating a Clinical Trial or obtaining Regulatory Approval f or use of a pharmaceutical or biological product in combination with another pharmaceutical or biologic al product, where a Clinical Trial had been initiat ed or Regulatory Approval obtained for such first pharmac eutical or biological product for use as monotherap y or in combination with a different pharmaceutical or biol ogical product, will not be considered to be a new Indication ; and ( iv ) initiating a Clinical Trial or obtaining R egulatory Approval for use of a pharmaceutical or b iological product in a specific patient population where a Cl inical Trial had been initiated or Regulatory Appro val obtained for such pharmaceutical or biological prod uct without reference to a specific patient populat ion or for a different patient population, will not be considere d a new Indication