definiens: means, with respect to a Product, any pharmaceutic al product ( a ) that is sold by a Personother than a Party or its Affiliates, or any licens ee of such Party or its Affiliates, and who did not purchase suchproduct in a chain of distribution that included su ch Party or its Affiliate or licensee of either of the foregoing,(b ) contains the same Compound as such Product, and ( c ) whose Marketing Authorization Application is a pproved bya Regulatory Authority in reliance, in whole or in part, on the prior approval ( or on safety or effica cy data submitted insupport of the prior approval or on the finding by a Regulatory Authority of the safety or efficacy ) o f such Product, including any product authorized for sale ( i ) in th e U.S. pursuant to Section 505(b)(2 ) or Section 505 ( j ) of the Act ( 21U.S.C. 355(b)(2 ) or 355(j ), respectively ), ( ii ) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliamentand [ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITHTHE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF1934, AS AMENDED