definiens: means a Product ( other than aNew Combination Product ) that is sold together with any other products and/or services at a unit price, whether packagedtogether or separately with another pharmaceutical product or other device, equipment, instrumentation, or other components(other than solely containers or packaging exclusively for the Product).”(b ) Added Definition . The following defined term shall be added as Section 1.68 of the [COMPANY] License, to read in itsentirety as follows : means a pharmaceutical product that ( i ) is not sold by BDSI, its Affiliates, or, under a license from BDSI, itssublicensees or is not otherwise authorized by BDSI to be sold by any such entity, ( ii ) contains fentanyl and is administered ina transmucosal formulation ; and ( iii ) has obtained Approval under 21 U.S.C. 505(j ) ( or any successor legislation or similarlegislation for approval of a generic product ) . ” means a pharmaceutical product that ( i ) contains * * * as the sole active ingredients and ( ii ) isadministered in a transmucosal formulation utilizing the BEMA Technology . means the pharmaceutical product known as fentanyl buccal soluble film, having an NDA # 22 266