definiens: means, with respect to a Licensed Product, a use to which suchLicensed Product is intended to be put for the treatment, prevention, mitigation, cure or diagnosis of arecognized disease - 8 – or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptomsassociated with a recognized disease or condition, in each case for any size patient population, which, ifsuch Licensed Product is approved in the U.S., would be reflected in the sectionof labeling pursuant to 21 C.F.R. § 201.57(c)(2 ) or, to the extent applicable, any comparable labelingsection outside the U.S., subject to the following : ( a ) subtypes of the same disease or condition are notadditional Indications for such Licensed Product ; ( b ) different symptom domains or domains ofimpairment of the same disease or condition are not additional Indications for such Licensed Product ; ( c)the approved use of such Licensed Product for such disease in different combinations or co - therapies oftreatments are not additional Indications for such Licensed Product ( e.g., monotherapy vs. add - on orcombination therapy with another agent in the same disease ) ; ( d ) treatment, prevention and cure of thesame disease or the same disease subtype with such Licensed Product are not additional Indications forsuch Licensed Product ; ( e ) the approved use of such Licensed Product for such disease in a different lineof treatment or a different temporal position in a treatment algorithm for the same disease or condition arenot additional Indications for such Licensed Product ( e.g., first line vs. second line therapy in the samedisease or condition ) ; and ( f ) treatment of the same disease or condition with such Licensed Product inan expanded, modified or additional patient population are not additional Indications for such LicensedProduct