definiens: means, with respect to a particular Licensed Product in a particular country, a product on the marketin such country commercialized by any Third Party that is not an Aﬃliate or Sublicensee of [COMPANY] and that did no tpurchase such product in a chain of distribution that inclu ded any of [COMPANY] or its Aﬃliates or Sublicensees, that ( a ) isapproved by the applicable Regulatory Authority, under any then - existing laws and regulations in the applicable countrypertaining to approval of products with no clinically mea ningful diﬀerences as a,, or version ( or terms of similar meaning ) of such Licensed Prod uct, which approval uses such Licensed Product as areference product and relies on or references any informa tion in the approval application for such Licensed Produ ct, or(b ) is otherwise recognized by the applicable Regulatory A uthority as a, or product(or other term of similar meaning ) with no clinically m eaningful differences to such Licensed Product