definiens: means a pharmaceutical product that contains an Exclusive Licensed Compound as an acti ve ingredient and for which a Third Party : ( a ) obtains Marketing Authorization based on an application that references, or otherwise relies upon the approval of an Exclusive Licensed Compound in the Licensed Product, including any application submitted und er section 505(b)(2 ) or 505(j ) of the FDCA that cites an Exclusive Licensed Compound in the Licensed Product as a listed drug or any application under Section 351(k ) of the United States Public Health Service Act that cites an Exclusive Licensed Compound i n the Licensed Product as the reference product ; or ( b ) otherwise receives Regulatory Approval as a generic, follow -on, hybrid, biosimilar, or interchangeable product from a Regulatory Authority in such country by referencing Regulatory Approvals ( or data therein ) of an Exclusive Licensed Compound in the Licensed Product