definiens: means, with respect to a Licensed Product, a diag nostic, prophylactic or therapeutic use for a disease or condition, which, ( a ) for a clinical trial for such Licensed Product, would be the use of such Licensed Product for which such clinica l trial is intended to determine safety or effectiv eness and ( b ) if the NDA for such Licensed Product is approve d in the U.S., would be reflected in the section of labeling pursuant to 21 C.F.R. § 201.57(c)(2 ) ( or comparable labelling section under Applicable Laws ) or, to the extent applicable, any comparable labeling section outside the U.S., in ea ch case ( ( a ) and ( b ) ), subject to the following, including the final sentence of this Section 1.92 : ( i ) subtyp es of the same disease or condition are not additional Indications for such Licensed Product ; ( ii ) uses of such Licen sed Product for the same disease or condition for different pop ulations or population sub - types are not additional Indications for such Licensed Product ; ( iii ) the approved use o f such Licensed Product for such disease or conditi on in different combinations or co - administration of trea tments are not additional Indications for such Lice nsed Product ( e.g., monotherapy vs. add - on or combination therapy wit h another agent in the same disease ) ; ( iv ) diagnosis, treatment, prevention and cure of t he same disease or disease subtype with such Licens ed Product are not additional Indications for such Licensed Pr oduct ; ( v ) the approved use of such Licensed Produc t for such disease or condition in a different line of treatme nt or a different temporal position in a treatment algorithm for the same disease or condition are not additional In dications for such Licensed Product ( e.g., first line vs. second line therapy in the same disease or condition ) ; and ( vi ) treatment of the same disease or condition wi th such Licensed Product in an expanded, modified or additi onal patient population are not additional Indicati ons for such Licensed Product