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 ab breviated 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 country ) as such Pro duct 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 equivalency de termination 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, a s is necessary to permit substitution of such product for the Product under Applicable Law in such country