definiens: means : ( a ) a single pharmaceutical formulation ( whether co - formulated or administered together via the same administration route)containing as its active ingredients both a Product and one or more other therapeutically or prophylactically active pharmaceutical or biologicingredients ( each an ), or ( b ) a combination therapy comprised of a Product and one or more Other Component(s ), whether priced and sold in a singlepackage containing such multiple products, packaged separately but sold together for a single price, or sold under separate price points butlabeled for use together, in each case, including all dosage forms, formulations, presentations, and package configurations . Drug delivery vehicles, adjuvantsand excipients will not be deemed to be, except in the case where such delivery vehicle, adjuvant or excipient isrecognized by the FDA as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7 ) . All references to Products in this Agreement shall bedeemed to include Combination Products