definiens: means either of ( 1 ) any pharmaceutical product ( other than the Atropine Product or Licensed Product itself ) that ( a ) isapproved by the Regulatory Authority in such country for at least one indication for which the Atropine Product obtained Regulatory Approval from theapplicable Regulatory Authority in such jurisdiction ( i ) through an abbreviated new drug application as deﬁned in 21 U.S.C. 355(j ) ( or equivalent outsidethe United States ) or ( ii ) as an A - rated therapeutically equivalent product ( or the foreign equivalent thereof ), including pursuant to an application under 21U.S.C. 355(b)(2 ) ( or the foreign equivalent thereof ) ; and ( b ) is sold in such jurisdiction by a Third Party that is not a sublicensee of [COMPANY] Health, or ( 2)any combination of pharmaceutical and medical device product that ( a ) contains ( i ) the same active pharmaceutical ingredient(s ) as the Atropine Productand ( ii ) a medical device that is intended to deliver such active pharmaceutical ingredient(s ) in substantially the same manner as the Licensed Product;(b ) is approved by the Regulatory Authority in such regulatory jurisdiction as a freely substitutable generic for such Licensed Product ; and ( c ) is sold insuch jurisdiction by a Third Party that is not a sublicensee of [COMPANY] Health