definiens: shall mean, with respect to a Product, on a countr y - by - country basis, a pharmaceutical product that : ( a ) is sold in a given country by a Third Party, other than a Related Par ty, a licensee or sublicensee of a Related Party, or any other Person in a chain of distribution originating from Provention, a Related Party or any of their respect i ve licensees or sublicensees ; ( b ) contains the sam e Candidate ( and, if applicable, the same Other Activ e(s ) ) as such Product in the same dosage form as su ch Product ; and ( c ) has been approved for marketing by the relevant Regulatory Authority in such country in reliance on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for marketing ( i ) in the United States, pursuant to Section 505(b)(2 ) o r Section 505(j ) of the Act ( 21 U.S.C. § 355(b)(2 ) or 21 U.S.C . § 355(j ), respectively ), ( ii ) in the European Unio n or a European Union member state, as a pursuant to Article 10 of Parliament and Council Directive 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ), or ( iii ) in an y other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approval of such pharmaceutical product is base d on reference to the Marketing Approval for such Product in such country and a demonstration of bio- equivalence to such Product and which may be substituted for the Product without any action by t he physician or health care practitioner