definiens: means : ( a ) a single pharmaceutical formulation [ * * * ] conta ining, as its active ingredients, both ( i ) a Collaboration Product or Financial PCV or Financial SAV, on the one hand, and ( ii ) one or more Other Component(s ), on the other hand, or 6 ( b ) a combination therapy comprised of ( i ) a Collab oration Product or Financial PCV or Financial SAV, on one hand, and ( ii ) one or more Other Compon ent(s ), on the other hand, either when ( 1 ) priced a nd sold in a single package containing such multiple produc ts, or ( 2 ) packaged separately but sold together fo r a single price, in each case, including all dosage forms, formulati ons, presentations, and package configurations . Dru g delivery vehicles, adjuvants and excipients will not be deem ed to be, except in the case w here such delivery vehicle, adjuvant or excipient is recogniz ed by the FDA as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7 )