definiens: means, with respect to a Product in a particularregulatory jurisdiction, on a Product - by - Product and country - by - country basis, anypharmaceutical product ( other than the Product itself ) that ( a ) is approved by the RegulatoryAuthority in such country for at least one indication for which such Product obtained RegulatoryApproval from the applicable Regulatory Authority in such jurisdiction ( i ) through an abbreviatednew drug application as defined in 21 U.S.C. 355(j ) ( or equivalent outside the United States ) or(ii ) as an A - rated therapeutically equivalent product ( or the foreign equivalent thereof ), includingpursuant to an application under 21 U.S.C. 355(b)(2 ) ( or the foreign equivalent thereof ) ; and ( b ) issold in such jurisdiction by a Third Party that is not a Sublicensee and did not purchase suchproduct in a chain of distribution that included any of [COMPANY] Health or its Affiliates orSublicensees )