definiens: means, with respect to a particular Product in a particular country, a product on the market in such country commercialized by any Third Party that is not a Sublicensee and that did not purchase such product in a chain of distribution that included any of [COMPANY] or its Affiliates or Sublicensees, that ( a ) is approved by the applicable Regulatory Authority, under any then -existing laws and regulations in the applicable country pertaining to approval of generic or biosimilar biologic products, as a or version of such Product, which approval uses such Product as a reference product and relies on or references pivotal safety or efficacy data in the Approval Application for such Product or ( b ) otherwise meets the criteria for constituting a or product pursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. § 262(k ) ) or EMA Directive 2001/83 / EC or any foreign equivalent thereof or successors thereto