definiens: means, with respect to a Product being sold in a country, a pharmaceutical product that : ( a ) containsas the active ingredient the Licensed Compound in such Product ( or any salt, hydrate, solvate or ester of such LicensedCompound ), and ( b ) is authorized for sale and use in the country on the basis of a marketing authorization that relies, in wholeor in part, on safety and efficacy data in the NDA submitted to obtain Regulatory Approval for such Product in the country, without a right of reference or other authorization from [COMPANY] or any of its Related Parties, such marketing authorizationbeing : ( i ) in the U.S. pursuant to Section 505(b)(2 ) or Section 505(j ) of the Act, as amended ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C