definiens: means ( a ) icosapent ethyl capsules or ( b ) any other preparations Controlled by [COMPANY] containingicosapent ethyl or ethyl eicosapentaenoic acid as the only active pharmaceutical ingredient and only Active Moiety, ineach case of clauses ( a ) and ( b ), as approved by the competent Governmental Authority for sale in the United Statesand sold under either the Vascepa ® trademark or another trademark Controlled by [COMPANY], or outside the UnitedStates and outside the Territory by or under license from [COMPANY], or as permitted under this Agreement to beapproved and sold in the Field in the Territory . [ * * * ] 1.69 means the approval of a Governmental Authority necessary for the marketing and saleof the Product in a given country or regulatory jurisdiction, which may include the approval of an IDL, but which shallexclude any pricing or reimbursement approvals