definiens: means, with respect to a Product, any intranasal productin an intranasal device that ( i ) is sold by a Third Party under an ( A ) Abbreviated New DrugApplication ( ANDA ) in the United States ; ( B ) in the European Union, pursuant to aprovision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC asamended ( including an application under Article 6.1 of Parliament and Council Regulation(EC ) No 726/2004 that relies for its content on any such provision ), or ( C ) in any othercountry or jurisdiction, pursuant to all equivalents of such provisions ; ( ii ) containsnaloxone as the primary active ingredient ; and ( iii ) is approved in reliance, in whole or inpart, on the prior approval of such Product . A Product licensed or produced by Adapt or itsAffiliates or Commercial Sublicensees ( i.e., an authorized generic product ) will notconstitute a Generic Product . ”4