definiens: means, with respect to a given Licensed Product i n a particular country in the Territory, any product sold by a Third Party no t authorized by Licensee or its Affiliates or subli censees that is approved by the applicable Regulatory Authority for such country through any application or submiss ion filed with a Regulatory Authority for Regulatory Approval of a biological product, where such product was el igible for and achieved such Regulatory Approval pursuant to an abbreviated follow - on biological approval pat hway based on claims of such product to be biosimilar or interchangeable to such Licensed Product or otherw ise relying on the approval of such Licensed Product in such country, including, for example, an applicati on filed under 42 U.S.C. § 262(k ) or its successor provision s or any similar provisions in a country outside th e United States, based in reliance, at least in part, on dat a underlying the Regulatory Approval of such Licens ed Product