definiens: means, wit h respect to a Licensed Product, and on a Licensed Product -by - Licensed 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 Licensed Product, that in each case, ( a ) is sold in the same country ( o r is commercially available in the same country via import from another country ) as such Licensed 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 inc luded any of [COMPANY] or any of its Affiliates or its Sublicensees, and ( b ) meets the equivalency 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 Licensed Product ), in each case, as is necessary to permit substitution of such product for the Licensed Product under Applicable Law in such country