definiens: means : ( i ) a generic transdermal patch phannaceutical product containing bupivacaine as the only active ingredient that is bioequivalent to and substitutable ( i.e., or therapeutic equivalence code or other therapeutic equivalence code hereafter created with similar meaning ) for Licensed Product and is sold under an ANDA pursuant to the FDC Act or, if sold outside the United States, pursuant to the Applicable Law of the relevant jurisdiction following expiry of any and all Marketing Exclusivity Rights for Licensed Product in such jurisdiction ; ( ii ) a generic transdermal patch pharmaceutical product containing bupivacaine as the only active ingredient that is bioequivalent to and substitutable for Licensed Product and sold under Article 10 of the EU Directive 2001l83 / EC or other Applicable Laws of the relevant jurisdiction fellowing expiry of any and all Marketing Exclusivity Rights for Licensed Product in such jurisdiction ; or ( iii ) a generic bupivacaine product that is bioequivalent to and substitutable for Licensed Product under the Applicable Laws relating to generic phannaceutical products of the relevant jurisdiction in the Territory other than in the United States or the EU . For clarity, a Generic Product shall not include any product sold by [COMPANY], its Affiliates or licensees