Development and License Agreement研发及许可协议完整篇doc.docx
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DevelopmentandLicenseAgreement研发及许可协议完整篇doc
DevelopmentandLicenseAgreement研发及许可协议-
Asusedherein,thefollowingtermswillhavethefollowingmeanings:
1.1AFFILIATEmeansanyentitythatdirectlyorindirectlyOwns,isOwnedbyorisundercommonOwnershipwith,apartytothisAgreement,whereOwnorOwnershipmeansdirectorindirectpossessionofatleastfiftypercent(50%)oftheoutstandingvotingsecuritiesofacorporationoracomparableownershipinanyothertypeofentity,provided,however,thatifthelawofthejurisdictioninwhichsuchentityoperatesdoesnotallowfiftypercent(50%)orgreaterownershipbyapartytothisAgreement,suchownershipinterestshallbeatleastfortypercent(40%).ThetermAffiliateshallnotincludeDDD,Inc.,_________,priortothetimeCCCdeliversnoticetoAAAdesignatingDDDasitsAffiliate.
1.2BUDGETmeanstheannualbudgetapprovedbythepartiesfromtimetotimepursuanttoARTICLE3.3(d).
1.3COSTOFGOODSSOLDmeansthemanufacturingcostofProductsoldbyCCC,itsAffiliatesandsublicensees,calculatedinaccordancewithreasonablecostaccountingmethodsofsuchparties,providedthatsuchmethodscomplywithgenerallyacceptedaccountingprinciplesandthefurtherprovisionsofthisARTICLE1.3.CostofGoodsSoldshallconsistofdirectlaborandmaterialsandareasonableallocationofindirectlabor,facilitiesexpense(includingdepreciationovertheexpectedlifeofthebuildingsandequipment),andadministrationcosts.CostofGoodsSoldshallexcludecostsassociatedwithprocessdevelopment,initialProductbatchesforregulatoryapproval,plantstart-upcosts,excesscapacity,ThirdPartyroyalties,oranycostsforwhichprovisionhasbeenmadeinthedefinitionofNetSales.IntheeventofanytransferofProductamongCCC,itsAffiliatesorsublicensees,theCostofGoodsSoldshallexcludeanyprofitorothermark-upbyanysuchparties.
1.4COVER(includingvariationsthereofsuchasCovered,Coverage,orCovering)shallmeanthatthemanufacture,useorsaleofaparticularproductwouldinfringeaValidClaimofanissuedpatentintheabsenceofrightsundersuchpatent.ThedeterminationofwhetheraproductisCoveredbyparticularpatentrightsshallbemadeonacountrybycountrybasis.
1.5DEVELOPMENTCOSTSmeanthecostsincurredbyAAAorforitsaccountaftertheEffectiveDatewhichareconsistentwiththeDevelopmentPlanandarespecificallyattributabletothedevelopmentofProducts.SuchcostsshallmeanthedirectcostsandtheindirectcostsofallAAAdevelopmentpersonnelandanythirdpartycosts,allofthemincurredtofurthertheProductdevelopmentprogram.IndirectcostsrelatedtotheDevelopmentPlanshallincludebutnotbelimitedtosalaries,employeebenefits,useoffacilitiesandequipment,personnel,travelmaterialsandsupplies,whichshallbeabsorbedintotheDevelopmentCostsbasedongenerallyacceptedaccountingprinciplesandmethodsapprovedbyCCC,suchapprovalnottobeunreasonablywithheld.
1.6DEVELOPMENTPLANmeanstheplanforthedevelopmentofProductsapprovedfromtimetotimepursuanttoARTICLE3.3.TheinitialDevelopmentPlan,reflectingthemutualobjectivesofthepartieswithrespecttothesequenceofeventsleadinguptothefilingofregulatorysubmissions,hasbeenagreedtobythepartiesasoftheEffectiveDate.
1.7EUROPEANUNIONorEUmeansthefollowingcountries:
Austria,Belgium,Denmark,Finland,France,Germany,Greece,Ireland,Italy,TheNetherlands,Portugal,Spain,Sweden,andtheUnitedKingdom.
1.8FIRSTCOMMERCIALSALEmeansthefirstsale,inanyparticularcountry,byCCCoritsAffiliatesorsublicenseesofProductforusebythegeneralpublicafterrequiredmarketingandpricingapprovalhasbeengrantedbythegoverninghealthauthorityofthatcountry.
1.9GENERICALLYEQUIVALENTPRODUCTshallmeanaproductmarketedbyaThirdParty,notunderlicensefromCCC,whichcontainsasanactiveingredientaninfluenzaneuraminidaseinhibitorthecompositionofmatterofwhichiswithinthescopeofaAAAPatentRightoraJointPatentRight.
1.10AAAKNOW-HOWmeansallproprietaryinventions,technology,tradesecrets,clinicalandpreclinicalresults,andanyphysical,chemicalorbiologicalmaterial,orotherinformationexcludingAAAPatentRightsandJointPatentRights,ownedoracquiredwithrighttosublicenseduringthetermofthisAgreementbyAAAoranyAffiliateofAAA,whicharenecessaryorusefultoCCCinthedevelopment,formulation,manufacture,useorsaleofProducts.
1.11AAAPATENTRIGHTSmeantherightsunderpatentsandpatentapplications,bothforeignanddomestic,which(a)Coveraninfluenzaneuraminidaseinhibitor,oritsmanufacture,formulationoruse,includingintermediatesforthemanufactureorusethereof,(b)arebasedonaninventionmadeatanytimepriortothefifthanniversaryoftheEffectiveDateand(c)areownedbyorlicensedtoAAAoranyAAAAffiliatewiththerighttosublicense.Notwithstandingtheforegoing,AAAPatentRightsshallexcludeJointPatentRightsbutshallincludeAAAPatents,whicharedefinedasthosepatentsandpatentapplicationsownedbyorlicensedtoAAAoranyAAAAffiliatewiththerighttosublicensethatareencompassedwithinAAAPatentRights.SetforthasExhibitAisalistoftheAAAPatentsasoftheEffectiveDate.SuchExhibitshallbeupdatednomorefrequentlythanannuallyuponCCC’srequest.
1.12IND(ORINVESTIGATIONALNEWDRUGAPPLICATION)meansanapplicationasdefinedintheUnitedStatesFood,DrugandCosmeticActandapplicableregulationspromulgatedthereundertotheUnitedStatesFoodandDrugAdministration(theFDA)ortheequivalentapplicationtotheequivalentagencyinanyothercountryorgroupofcountries,thefilingofwhichisnecessarytocommenceclinicaltestingofProductsinhumans.
1.13JOINTPATENTRIGHTSmeantherightsunderpatentsandpatentapplications,bothforeignanddomestic,which(a)Coveraninfluenzaneuraminidaseinhibitor,oritsmanufacturingformulationoruse,includingintermediatesforthemanufactureorusethereof,(b)arebasedonaninventionmadeatanytimepriortothefifthanniversaryoftheEffectiveDate,and(c)areownedjointlybyAAAandCCC.ExhibitAshallbeamendedtoincludeJointPatentswhensuchpatentapplicationsarefirstfiled.
1.14NDA(ORNEWDRUGAPPLICATION)meansanapplicationasdefinedintheUnitedStatesFood,DrugandCosmeticActandapplicableregulationspromulgatedthereundertotheUnitedStatesFDAortheequivalentapplicationtotheequivalentagencyinanyothercountryorgroupofcountries,thefilingofwhichisnecessarytocommencecommercialsaleofProducts.
1.15NETSALESmeansthegrosssalesinvoicedbyCCC,itsAffiliatesorsublicenseesforProducttoThirdPartiesotherthansublicensees,lessdeductionsofreturns(includingwithdrawalsandrecalls),rebates(pricereductions,includingMedicaidandsimilartypesofrebates,e.g.chargebacks),volume(quantity)discounts,discountsgrantedatthetimeofinvoicing,salestaxesandothertaxesdirectlylinkedtoandincludedinthegrosssalesamountascomputedonaproductbyproductbasisforthecountriesconcerned(hereinafterreferredtoasAdjustedGrossSales).
FromtheAdjustedGrossSalesthereshallbealumpsumdeductionof
[]forthosesales-relateddeductionswhicharenotaccountedforonaproductbyproductbasis(e.g.,outwardfreights,transportationinsurance,packagingmaterialsfordispatchofgoods,customduties,discountsgrantedlaterthanatthetimeofinvoicing,cashdiscountsandotherdirectsalesexpenses).
InthecaseofProductsbeingsoldaspartofacombinationproductcontainingtheProductandoneormoreothertherapeuticallyactiveingredients,thepartiesshallnegotiateanappropriateroyaltyadjustmenttoreflecttherelativesignificanceofeachsuchingredient,basedontheestimatedfairmarketvalueofeachsuchtherapeuticallyactiveingredient.
Notwithstandingtheforegoing,amountsreceivedbyCCCoritsAffiliatesorsublicenseesforthesaleofLicensedProductsamongCCCanditsAffiliatesorsublicenseesforresaleshallnotbeincludedinthecomputationofNetSaleshereunder.
1.16PHASEIIICLINICALTRIALmeansanyclinicaltrialprimarilydesignedtoserveasapivotal,well-controlledstudyuponwhichapprovalofanNDAwillbebased,includingsuchastudyreferredtoordenominatedasaPhaseII/IIIstudyintheUnitedStatesortheequivalentelsewhere.
1.17PRODUCT(S)meansanypharmaceuticalproductcontaininganinfluenzaneuraminidaseinhibitorCoveredbyaAAAPatentRight,aCCCPatentRightoraJointPatentRight.
1.18PROPRIETARYINFORMATIONmeans,subjecttothelimitationssetforthinARTICLE12.1hereof,allinformationdisclosedbyapartyheretototheotherpartypursuanttothisAgreement.Inparticular,ProprietaryInformationshallbedeemedtoinclude,butisnotlimitedto,informationrelatingtoresearchanddevelopmentprogramsandresults,therapeuticcandidatesandproducts,clinicalandpreclinicaldata,tradesecrets,businessstrategy,patentapplications,licenses,suppliers,manufacturers,productandmarketingstrategy,customers,marketdata,personnelandconsultants.
1.19CCCKNOW-HOWmeansallproprietaryinventions,technology,tradesecrets,clinicalandpreclinicalresults,andanyphysical,chemicalorbiologicalmaterial,orotherinformationexcludingCCCPatentRightsandJointPatentRights,ownedoracquiredwithrighttosublicenseduringthetermofthisAgreementbyCCCoranyAffiliateofCCC,whicharenecessaryorusefultoCCCinthedevelopment,formulation,manufacture,useorsal