ManufacturingandSupplyAgreement制造与供给合.docx

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