definiens: means, with respect to a particular Licensed Prod uct in a given country, the first commercial sale of such Licensed Product foll owing Marketing Approval in such country by or unde r authority of a Party or any of [COMPANY] ’s Sublicensees . As used herein, means all approvals, licenses, registrations or authorizations of any fe deral, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturin g, use, storage, import, transport and sale of Lice nsed Products in a country or regulatory jurisdiction . For countr ies where governmental approval is required for pri cing or reimbursement for the Licensed Product, shall not be deemed to occur until such p ricing or reimbursement approval is obtained ; provided, to th e extent the applicable Party or any of [COMPANY] ’s Subli censees sell a Licensed Product prior to obtaining such pri cing or reimbursement approval, such sales shall be accrued at the time of sale and any royalties thereon shall be paid in the quarter following the obtaining of suc h pricing or reimbursement approval . For the purpose of clarity and subject to Section 1.100(a ), sales of Licensed Products between or among any Party, [COMPANY] ’s Affiliates and GN E ’s Sublicensees shall be excluded from 5 Certain confidential information contained in this document, marked by [ * * * ], has been omitted because it is both ( i ) not material and ( ii ) is the type th at the registrant treats as private or confidential