definiens: means ( a ) a single pharmaceutical product, in any dosage strengths, formulations and methods of administration, that combines the Compound and one or more other active ingredients in fixed dose combination ( a ), ( b ) acombination treatment that includes Product and at least one product containing additional active ingredient that is not co - formulated with theCompound but is approved ( or being developed for approval ) for use in combination and that is sold ( i ) in a single package containingseparate dosage forms of Product and the additional active ingredient or ( ii ) in a bundle of separate packages at a single price ( a ), or ( c ) a combination therapy that includes Product and at least one product containing additional active ingredientthat is not co - formulated with the Compound but is approved ( or being developed for approval ) for use as part of a single course of treatmentand is sold separately, potentially by different Entities ( a ) . For clarity, performance of a drug - to - drug interaction studyshall not, in itself, constitute development of a Combination and an approval that a Product is safe for use in connection with a second product(as opposed to an approval based on the efficacy of use of a Product in connection with a second product ) shall not, in itself, create aCombination