definiens: means, with respect to a Licensed Product, on a cou ntry - by - country basis, the first sale for monetary value of such Licensed Prod uct under this Agreement by [COMPANY], its Affiliates or its sublicensees to an end user for use, consumption or resale of such Licensed Product in such country in the Field after all Regulatory Approvals of such Licensed Pro duct ( i.e., when all applicable approvals, licenses, registrations or authorizations described in the definition of Re gulatory Approval that are necessary to sell the ap plicable Licensed Product ) have been obtained in such countr y in the Field, where such sale results in the reco gnition of Net Sales . The sale of a Licensed Product under thi s Agreement by [COMPANY] to an Affiliate of [COMPANY] or a sublicensee of [COMPANY] shall not constitute a First Commercial S ale unless such Affiliate or such sublicensee is 7 [ * * ] = Portions of this exhibit have been omitted p ursuant to a confidential treatment request . An unredacted version of this exhibit has been filed s eparately with the Commission