definiens: means a separate and distinct disease, disorder o r condition in humans : ( a ) which a Product is intended to treat or prevent, as evidenc ed by the protocol for a clinical trial of such Pro duct or by the proposed Product labeling in an MAA filed with a Re gulatory Authority for such Product ; or ( b ) which i s contained in a Product ’s labeling approved by a Regulatory Au thority as part of the Regulatory Approval for such Product, it being understood that : ( i ) the treatment or prev ention of separate varieties of the same disease, d isorder or condition ( e.g., acute vs. chronic ) shall not be treated as separa te Indications ; ( ii ) the treatment or prevention of the same disease, disorder or condition in differen t populations ( e.g., adult and pediatric ; or 6 treatment - naïve and relapsed / refractory ) shall not be treated as separate Indications ; and ( iii ) preve ntion of a disease, disorder or condition shall not be treated as a separate Indication from treatment of the sam e disease, disorder or condition