definiens: means, with respect to a Product, and on a Product -by - Product and country -by - country basis, any product ( including a or ) approved by way of an abbreviated regulatory mechanism by the relevant Regulatory Authority in a country in reference to such Product, that in each case : ( a ) is sold in the same country ( or is commercially available in the same country via import from another coun try ) as such Product by any Third Party that is not a Sublicensee of [COMPANY] or its Affiliates and that did not purchase such product in a chain of distribution that included any of [COMPANY] or any of its Affiliates or its Sublicensees ; and ( b ) meets the equiva lency determination by the applicable Regulatory Authority in such country ( including a determination that the product is or other term of similar meaning, with respect to the Product ), in each case, as is necessary to permit substitution of such product for the Product under Applicable Law in such country