OEM-contract

ExecutionVersion1FRAMEOWNBRANDINGAGREEMENTThisOwnBrandingAgreement(this“Agreement”)ismadeasofthis1stdayofApril,2014(the“EffectiveDate”)byandbetweenAcompany,acorporationorganizedunderthelawsofthedistrict/country,withanaddressatAaddress(“OEMManufacturer”)andBcompany,togetherwithitsaffiliate[s],whichisincorporatedunderthelawsofdistrict/country,havingaplaceofbusinessatBaddress(together,OwnBrander).RecitalsA.OEMManufacturerisengagedinand/orhasrightsrelatedtothedevelopment,manufactureand/orsaleofActiveImplantablemedicaldevicesandrelatedsuppliesandservices,includingwithregardtotheCE-markedProductName,Model:***.B.OwnBranderisexperiencedwiththepromotion,distributionandsaleofmedicaldevicesandrelatedsuppliesandservicesanddesirestobecomeanauthorizedOwnBranderofOEMManufacturermedicalproducts.C.OEMManufacturerdesirestoappoint****asitsOwnBranderforitsProducts,subjecttothetermssetforthbelow.AgreementInconsiderationofthemattersstatedintheRecitalsheretoandthemutualcovenantscontainedinthisAgreement,thepartiesagreeasfollows:1.0DEFINITIONSWhenusedinthisAgreement,eachofthefollowingtermsshallhavethedefinitionsetoutbelow:Agreement:“Agreement”meansthisagreement,togetherwithExhibitsA,whichareattachedheretoandwhichareanintegralparthereof.Complaint:“Complaint”meansanywritten,electronicororalcommunicationthatallegesdeficienciesrelatedtotheidentity,quality,durability,reliability,safety,effectiveness,orperformanceofaDeviceafteritisreleasedfordistribution.Term:theperiodoftwelve(12)monthsfollowingtheEffectiveDate,andanyrenewalperiodmutuallyagreedbetweenthepartieshereto.2.0APPOINTMENTASOWNBRANDER22.1TheOEMManufacturerappoints**asauthorizednon-exclusiveOwnBrandertomarketanddistributetheDeviceunderthenameofOwnbrander.Fromtimetotime,OEMManufacturerandOwnBrandermayenterintoaspecificagreement,settingforththetermsandconditionsuponwhich,OwnBranderwillmarketDevicesintocertainterritories,tobemutuallyagreed.Suchspecificagreementwillbesubjecttothetermsherein.2.2TheDevicemanufacturedbytheOEMManufacturer(includingmaterial,packaging,instructionsforuseandlabeling)willbedistributedbytheOwnbranderinhisownresponsibilityunderhisownname.ThereforetheOwnbranderisconsideredthemanufactureraccordingtothedirectiveAIMD90/385/EEC.2.3TheOEMManufacturerwillprovidetotheOwnbrandercopyofthevalidCEcertificateinplaceandISO13485toallowapplyingtheCEMarkontheDeviceandtodistributetheDeviceintheEuropeanUnion.2.4TheOEMManufacturerwillprovidetoOwnBranderawrittendeclarationthatthesuppliedDevicesareexactlythesameproductascoveredbytheCEcertificateandisproducedonthesameproductionlocationunderidenticalconditionsexceptfortheOBLdetailsontheproductlabeling.2.5ThisconfirmationallowstheOwnbrandertorefertothetechnicaldocumentation,manufacturingandfinalinspectionoftheOEMManufacturer,whichareintheresponsibilityoftheOEMManufacturer.2.6TheNotifiedBodyofeachpartywillhavetherighttoperformauditsattheotherpartyorrequestinformationfromhimifneeded.2.7TheOwnBranderwillhavetherighttoaudittheOEMManufactureroranyofitssubcontractorsatanytimeuponreasonablepriornotice.3OWNBRANDEROBLIGATIONS3.1InadditionandnotbywayoflimitationoftheotherdutiesandobligationsofOwnBrandersetforthinthisAgreement,atalltimesduringtheTermtheOwnBrandershall:(a)UseitsbesteffortstopromoteandselltheDeviceandtorepresenttheinterestsofOEMManufactureratalltimestoend-usercustomersintheOwnBranderTerritory.OwnBranderagreestoactinasalescapacityinaccordancewiththedirectionofOEMManufacturer’ssalesmanagerorotherdesignatedmanager;(b)Maintainalocalsalesforceofadequatesize,qualification,andattentiontorepresentandpromotethesaleoftheDevice.ThesalesforceshallbeemployeesorauthorizedagentsofOwnBrander.SalesforcemustcompleterequisitetrainingtolevelofcompetencytobedefinedbyOEMManufacturerpriortorepresentation,sales,serviceandmaintenanceofcustomerbasewhereDevicearesold;Theexpensesassociatedwithhiring,employingandtrainingtheabovementionedsalesforcewillbepaidbytheOEMManufacturer.3(c)PromptlyfollowingreceiptorbecomingawareofaComplaintasdefinedinSection1.0concerningtheDevice,notifyOEMManufacturerofanyinformationofwhichOwnBranderbecomesawarethatsuggeststhatanyoftheDevicesmayhavebeenassociatedwithacomplaint,andrefertoOEMManufactureranyinquiry(otherthanapurchaseorderorpotentialpurchaseorder)fromthepublic,anygovernmentalauthority,anytradeassociationoranynewsmedia,publicationorreporterconcerningtheProductsorOEMManufacturersothatOEMManufacturermaycoordinatearesponsetosuchinquirywithOwnBrander;(d)useitsbesteffortstopromoteandselltheProductswithintheTerritory,includingbutnotlimited,to(i)presentingtheProductsatexhibitionsandOwnBrander’swebsite,(ii)sendingphysiciansofthehospitalsandclinicswithwhomitworkstocoursesrunbyOwnBranderfromtimetotime,(iii)includingalinkontheOwnBrander’swebsitetoOEMManufacturer’swebsite,(iv)translatingandprintingOEMManufacturer’spromotionalandoperationalmaterialrelatedtotheProductsifrequired,providedthatthetext,format,contentandcirculationofsuchtranslationsshallbesubjecttoOEMManufacturer’spriorwrittenapproval(fortheavoidanceofanydoubt,theOwnBranderac