definiens: means, with respect to a particular Licensed Prod uct in a country, a pharmaceutical product that ( a ) contains a highly s imilar ( if such Licensed Product is regulated in su ch country as a biological product ) or identical ( if such Lice nsed Product is regulated in such country as a smal l molecule or other new chemical entity product ) active ingredien t(s ) as such Licensed Product, ( b ) is approved for use in such country pursuant to an abbreviated or expedited reg ulatory approval process ( or other process for coun tries where there is no such abbreviated or expedited pro cess ) governing approval of generic pharmaceutical products or bio - similar products based on ( i ) the then - curre nt standards for regulatory approval in such countr y and/or on ( ii ) data generated by the Parties pursuant to this Agreement, and ( c ) is sold in the same country as such Licensed Product by any Third Party that is not a licensee o r sublicensee of [COMPANY] ( for such product or for s uch Licensed Product ) or an Affiliate of [COMPANY] and that did no t purchase such product in a chain of distribution that included any of [COMPANY] or its Affiliates or any such licens ees or sublicensees