definiens: means, with respect to a Product in a particular regulatory jurisdiction, anypharmaceutical product that ( a ) ( i ) contains the same active pharmaceutical ingredients as such Product, in the sameformulation and dosage form as such Product and for the same route of administration as such Product and isapproved by the Regulatory Authority in such country ( for an indication for which such Product obtained RegulatoryApproval from the applicable Regulatory Authority in such jurisdiction ) ; or ( ii ) is A / B Rated ( defined below ) with respectto such Product or otherwise approved by the Regulatory Authority in such country as a substitutable generic for suchProduct ( for an indication for which such Product obtained Regulatory Approval from the applicable RegulatoryAuthority in such jurisdiction ) on an expedited or abbreviated basis in a manner that relied on or incorporated datasubmitted by [COMPANY] or its Affiliate or sublicensee in connection with the Regulatory Approval for the Product in suchjurisdiction ; and ( b ) is sold in such jurisdiction by a Third Party that is not a sublicensee of [COMPANY] or its Affiliates anddid not purchase such product in a chain of distribution that included any of [COMPANY] or its Affiliates or sublicensees