definiens: means, with respect to any Licensed Product, the first sale to a Third Party for end useor consumption of such Licensed Product in a country in the Territory by or on behalf of [COMPANY], Aqua, their Affiliates, or their Sublicensees after receipt of Regulatory Approval ( and, if applicable, a Pricing Approval, when such approvalis mandatory or advisable for the Commercialization of the Licensed Product in a certain country of the Territory ) insuch 7EXECUTION DRAFT country or, where Pricing Approval is not required to launch Licensed Product, then the first sale for end use orconsumption of a Licensed Product to a Third Party in that country in the Territory in connection with the nationwideintroduction of such Licensed Product in that country in the Territory by or on behalf of [COMPANY], Aqua, its Affiliates, ortheir Sublicensees . Notwithstanding the foregoing, sales for no cash compensation, for sampling and promotional use, and compassionate use, shall not be considered to constitute a First Commercial Sale . First Commercial Sale shallbe determined on a country - by - country basis