ManufacturingandSupplyAgreement制造与供给合.docx
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ManufacturingandSupplyAgreement制造与供给合
ManufacturingandSupplyAgreement制造与供给合同-
ThefollowingcapitalizedtermsshallhavethefollowingmeaningswhenusedinthisAgreement.
1.1Affiliatemeans,withrespecttoaparticularParty,aperson,corporationorotherentitythat,directlyorindirectly,throughoneormoreintermediaries,controls,iscontrolledbyorisundercommoncontrolwithsuchParty.Forthepurposesofthisdefinition,controlmeansthedirectorindirectownershipbyaPartyofatleastfiftypercent(50%)oftheoutstandingvotingsecuritiesofthecontrolledentity;provided,thatinanycountrywherethelawdoesnotpermitforeignequityownershipofatleastfiftypercent(50%),thenwithrespecttocorporationsorganizedundersuchcountry’slaws,controlshallmeanthedirectorindirectownershipbyaPartyofoutstandingvotingsecuritiesofsuchcorporationatthemaximumamountpermittedbythelawofsuchcountry.
1.2Back-UpLicenseshallhavethemeaningsetforthinSection3.7(c).
1.3BusinessDaymeansanydaythatisnotaSaturday,Sundayorotherdayonwhich(a)banksintheStateofWashingtonareauthorizedorrequiredtocloseforthepurposesofanyactiontobetakenbyoranynoticetobeprovidedtoAAA,or(b)thebanksin_________(COUNTRY)areauthorizedorrequiredtocloseforthepurposesofanyactiontobetakenbyoranynoticetobeprovidedtoBBB.
1.4CollaborativeLicenseAgreementmeantheAgreementbyandbetweenthePartiesdated_________,_________,_________(M/D/Y).
1.5ComponentorComponentsshallmeaneitheraBBBComponentoraAAAComponent,dependinguponthecontextoftheapplicableSectionandthePartytowhichsuchsectionthenapplies.
1.6Controlledmeans,withrespecttoaparticularitem,material,orintellectualpropertyright,thataPartyownsorhasalicenseundersuchitem,materialorintellectualpropertyrightandhastheabilitytogranttotheotherPartyaccesstoand/oralicenseorsublicenseundersuchitem,materialorintellectualpropertyrightwithoutviolatingthetermsofanyagreementorotherarrangementwith,ortherightsof,anyThirdParty.
1.7AAAAntigenmeansanantigenthatisclaimedbyapatentorisotherwisecoveredbyintellectualpropertyrightsthatareControlledbyAAA.
1.8AAAComponentorAAAComponentsmeanaSeparationDevice,ReagentorAAAAntigen,oranycombinationthereof,otherthanacombinationwhichcomprisesaAAAProduct.
1.9AAAProductmeans:
(a)anytherapeuticproductcomprisingDendriticCellsthathavebeenactivatedorloadedwithaspecificantigen,engineeredantigenorantigengene,(includingwithoutlimitationAAAAntigen),foruseinhumantherapybyinfusionintoapatient,whichproducthasbeendevelopedbyAAAbasedontheAAATechnology;or(b)anyserviceprovidedbyoronbehalfofAAAtoapatientthatutilizestheAAATechnologyandinvolvesisolationorpreparationofDendriticCells,activationorloadingwithspecificantigen,engineeredantigenorantigengene,(includingwithoutlimitationAAAAntigen),andinfusionofsuchactivatedorantigenloadedDendriticCellsintoapatient.Further,thePartiesmayagreeinwritingtoamendandextendthedefinitionofAAAProductasprovidedinSection5.8oftheCollaborativeLicenseAgreement.
1.10AAATechnologymeanstheAAAKnow-How,theAAAImprovementsandtheAAAPatents,(assuchtermsaredefinedintheCollaborativeLicenseAgreement)eithercollectivelyoranypartthereof.
1.11DendriticCellmeansahumandendriticcellorotherantigen-presentingcellorothercellsfromwhichdendriticcellscanbederived.
1.12Fully-BurdenedManufacturingCostsmeanstheactualfullyburdenedcostsandexpensesofmanufacturingaparticularComponent,includingwithoutlimitationthecostsofallrawmaterialsandlabor(includingallallocablebenefits)usedorconsumedinsuchmanufacture,ThirdPartycontractmanufacturingcosts,packagingcostsandexpenses,allqualityassuranceandqualitycontrolrelatedexpenses,alloverheadamountsallocabletosuchmanufacturing(includingwithoutlimitationappropriatelyamortizedcapitalequipmentcosts),allroyaltyamountspayablebySuppliertoanyThirdPartybaseduponthemanufactureofsuchComponent,andallamountsrelatedtofailedproductionunitsoryieldlosses,alltheforegoingascalculatedinaccordancewith(i)U.S.generallyacceptedaccountingprinciplesconsistentlyappliedformanufactureofComponentsbyAAAand(ii)_________(COUNTRY)’sgenerallyacceptedaccountingprinciplesconsistentlyappliedformanufactureofComponentsbyBBB.
1.13Informationmeansanyandallinformationanddataofanykind,includingwithoutlimitationtechniques,inventions,practices,methods,knowledge,know-how,skill,experience,testdata(includingpharmacological,toxicologicalandclinicaltestdata),analyticalandqualitycontroldata,marketing,cost,salesandmanufacturingdataanddescriptions,compositions,andassays.
1.14BBBAntigenmeansanantigenthatisclaimedbyapatentorisotherwisecoveredbyintellectualpropertyrightsthatareControlledbyBBB.
1.15BBBComponentorBBBComponentsshallmeananyBBBAntigenoranyotherBBBproprietarycomponentofaBBBProduct,andanycombinationthereof,thatAAAiseitherunabletoprepareorgenerallydoesnotprepareforBBBorforitself.
1.16BBBProductmeans:
(a)anytherapeuticproductdevelopedbyoronbehalfofBBBbasedon,derivedfromorincorporatingtheAAATechnologythatcomprisesDendriticCellsthathavebeenactivatedorloadedwithaspecificantigen,engineeredantigenorantigengene,(includingwithoutlimitationaBBBAntigen),foruseinhumantherapybyinfusionintoapatient;or(b)anyserviceprovidedbyoronbehalfofBBBtoapatientthatinvolvesisolationorpreparationofDendriticCells,activationorloadingofaspecificantigen,engineeredantigenorantigengene,(includingwithoutlimitationaBBBAntigen),andinfusionofsuchactivatedorantigenloadedDendriticCellsintoapatient,whereinsuchserviceisbasedon,utilizes,comprisesorisderivedfromtheAAATechnology.ThePartiesmayagreeinwritingtoamendandextendthedefinitionofBBBProductasprovidedinSection5.8oftheCollaborativeLicenseAgreement.
1.17LicensedAAAProductshallhavethemeaningsetforthinSection2.3(b)oftheCollaborativeLicenseAgreement.
1.18LicensedBBBProductshallhavethemeaningsetforthinSection2.4(b)oftheCollaborativeLicenseAgreement.
1.19ManufacturingKnow-HowmeansallInformationotherthanPatentsnecessaryforthemanufactureofaBBBAntigenorAAAAntigenwhichissubjecttotheBack-UpLicense.
1.20ManufacturingPlanshallmeantheplanpreparedbytheSupplieranddeliveredtothePurchaserforitsreviewandapproval,ingoodfaith,whichplandetailstheSupplier’smanufacturingplanforachievingmanufactureoftheComponentsatlevelsatleastequaltothePurchaser’sforecastedordersforthefirstyearaftercommerciallaunchofthefirstBBBProductorAAAProduct,asapplicable.
1.21NetRevenuemeansthetotalrevenuereceivedbyaPartyforsaleorotherdispositionofaProductbysuchPartyoranAffiliateorSublicenseeofsuchPartytoaThirdPartylessthefollowingtotheextentactuallyincurredorallowedwithrespecttosuchsaleordisposition:
(i)reasonablecostspaid,ifany,bythePartytoaThirdPartyonaccountofapheresisperformedaspartoforinassociationwiththeProduct;(ii)discounts,includingcashdiscounts,orrebates,retroactivepricereductionsorallowancesactuallyallowedorgrantedfromthebilledamount;(iii)creditsorallowancesactuallygranteduponclaims,rejectionsorreturnsofProducts,includingrecalls,regardlessofthePartyrequestingsuch;(iv)freight,postage,shippingandinsurancechargespaidfordeliveryofProduct,totheextentbilled;and(v)taxes,dutiesorothergovernmentalchargesleviedonormeasuredbythebillingamountwhenincludedinbilling,asadjustedforrebatesandrefunds;provided,however,thatwithrespecttosalesofaparticularBBBProductorLicensedAAAProductbyBBBoritsAffiliateorSublicenseein_________(COUNTRY),thetotalrevenuereceived,assetforthaboveinthefirstlineofthisdefinition,shallnotinanyeventbelessthantheNHIPriceestablishedforinsurancereimbursementofSingleTreatment(asdefinedintheCollaborativeLicenseAgreement),lesstheaverageamountchargedbytheparticularhospitalpurchaserofsuchProductforthesamenumberofapheresisservicesandinfusionservicesneededforandperformedforSingleTreatment(asdefinedintheCollaborativeLicenseAgreement)wheresuchaveragesarecalculatedincludingallapheresisservicesorinfusionservices,asapplicable,thatwereperformedforanypurposeduringtheapplicableperiod.
1.22Patentmeans(i)avalidandenforceablepatent,includinganyextension,registration,confirmation,reissue,re-examinationorrenewalthereof;and(ii)totheextentvalidandenforceablerightsaregrantedbyagovernmentalauthoritythereunder,apatentapplication.
1.23ProductmeansaBBBProductoraAAAProduct.
1.24PurchasershallmeanthePartypurchasingComponentsfromtheotherPartytotheAgreement,asapplicable,intheapplicablesection.
1.25Reagentmeans,withrespecttoaparticularLicensedAAAProduct,anyproprietaryreagentofAAA(excludinganyreagentscontainedinaSeparationDevice)thatisrequiredforcommercialmanufactureand/oruseofsuchLicensedAAAProduct.
1.26ReasonableEffortsshallmeaneffortsandresourcescommonlyusedintheresearch-basedpharmaceuticalindustryfortheresearc