definiens: 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 Immu nocore Products in a country or regulatory jurisdiction . F or countries where governmental approval is require d for pricing or reimbursement for the [COMPANY] Product, shall not be deemed to occur until such pricing or reimbursement approval is obtained ; prov ided, to the extent [COMPANY] or any of its Sublic ensees sell a [COMPANY] Product prior to obtaining such pricin g or reimbursement approval, such sales shall be ac crued 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 l .54(a ), sales of Immunocor e Products between or among any of [COMPANY], its Affiliates and their Sublicensees shall be excluded from