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LifeSciences:SummaryofLegalHotTopicsforForeignInvestmentinPRCHealthcareand PharmaceuticalIndustryin2023-2024
SUMMARYOFLEGALHOT
TOPICSFORFOREIGN
INVESTMENTINPRC
HEALTHCAREAND
PHARMACEUTICALINDUSTRY
IN2023-2024
ThePeople’sRepublicofChina(“PRC”)istheworld’ssecondlargesthealthcareandpharmaceutical
market.AccordingtoFrost&Sullivan’sforecast,thePRChealthcareandpharmaceuticalmarketwill
increasetoUS$320billionby2025.TherehasbeenanupturninM&AactivityinthePRChealthcareandpharmaceuticalmarketsince20231.Attheendof2023,AstraZenecaannounceditsacquisitionof
GracellBiotechnologiesInc.,aleaderincelltherapyinthePRC,forUS$1.2billion,whichisthefirstM&AdealinwhichamultinationalpharmaceuticalcompanyfullyacquiredaPRCbiotechnologycompany.
BasedontheprojectexperienceandobservationsofKing&WoodMallesons’LifeSciences&HealthcareGroup,overthepastyear,foreign-investedpharmaceuticalenterprisesinthePRChaveremainedactiveinconductingM&A,technologylicensing,andotherrelateddeal-makingactivities.Weanticipatethis
trendwillpersistinto2024,despitetheuncertaintyoftheinternationalanddomesticmacroenvironmentandotherfactors.
LookingbackattheoveralllegalenvironmentforforeigninvestmentinthePRChealthcareandpharmaceuticalindustryin2023:
Firstly,thePRCgovernmentcontinuestointroducevariousfavorablepoliciesto:(i)encourageforeigninvestmentinthePRChealthcareandpharmaceuticalindustry.Thisisespeciallysointhefieldsrelatedtotheresearch,developmentandproductionofcelltherapydrugs,developmentandproductionof
drugsforrarediseasesandpediatrics,developmentandproductionofpharmaceuticalmanufacturing-relatedconsumables,research,developmentandmanufacturingofsmarthealthcareproductsfortheelderly,etc.2;(ii)supportforeigninvestorstoinvestinR&DcentersinthePRC,andtoconduct
technologyR&Dandindustrializedapplicationjointlywithdomesticenterprises;(iii)speedupthe
launchingofforeigninvestmentprojectsinbiopharmaceuticalfield;(iv)encourageforeign-invested
enterprisestocarryoutclinicaltrialsofcellandgenetherapydrugsthathavebeenmarketedoverseasinthePRCinaccordancewiththelaws;and(v)optimizethemarketingauthorizationapplication
proceduresfordrugsthataremarketedinthePRCandmanufacturedoverseastobemanufacturedin
thePRC.Furthermore,localgovernmentsarecontinuouslystrengtheningtheprotectionofforeign
investmentandimprovingthefacilitationofinvestmentandoperations3.Accordingtothestatistics
releasedbytheStateAdministrationforMarketRegulation(“SAMR”),bytheendofSeptember2023,
684,000foreign-investedenterpriseshadregisteredinthePRC,anincreaseof1.5%fromtheendoflastyear,indicatingasteadyriseinthenumberofnewlyestablishedforeign-investedenterprises.
Secondly,withrespecttolegislationandlawenforcementin2023,aseriesofsignificantlawsand
regulationscloselyassociatedwiththehealthcareandpharmaceuticalindustrywereeitherrevisedor
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enacted.Concurrently,aseriesoflawenforcementactivitiesinkeyfieldswerefrequentlycarriedout.Thesedevelopmentscouldpotentiallyexertasignificantinfluenceontheinvestment,M&A,licensing-in/out,anddailybusinessoperationsofforeign-investedpharmaceuticalenterprisesinthePRC.
ThisarticlereviewsandoutlinesthesubstantialchangesinthelegalenvironmentofthePRChealthcareandpharmaceuticalindustriesin2023-2024,aimingtoprovideguidanceandreferenceforforeign-
investedpharmaceuticalenterprisesconductingbusinessinthePRC.
I.RevisionstoPRCCompanyLaw
ThenewlyrevisedPRCCompanyLaw(the“NewCompanyLaw”)wasformallypromulgatedon
December29,2023,andwillcomeintoforceonJuly1,2024.Comparedtotheversioncurrentlyinforce,theNewCompanyLawadoptscomprehensiveamendmentsrelatedtocapitalcontributionrules,
corporategovernancestructure,shareholders’rights,responsibilitiesofdirectors,supervisorsandseniormanagement,etc.Amongtheseamendments,foreign-investedpharmaceuticalcompaniesshouldpay
particularattentiontothefollowing:
Firstly,theNewCompanyLawrequirestheshareholdersofalimitedliabilitycompanytomakefull
capitalcontributionwithinfiveyearsaftertheestablishmentofthecompany.Thisprovisionreplacesthelong-standingsubscribedcapitalsystemunderthecurrentlaw.Therefore,ifaforeigninvestorintendstosetupanewcompanyinthePRCaftertheNewCompanyLawcomesintoforce,itshallcomplywiththecapitalcontributionperiodrequiredundertheNewCompanyLaw.Furthermore,theNewCompanyLawprovidesthatexistingcompanies(includingforeign-investedcompanies)whosecapitalcontribution
periodexceedstherequiredperiodundertheNewCompanyLaw,shallgraduallyadjusttheircapitalcontributionperiodtomeetthestatutoryrequirement4.
Secondly,theNewCompanyLawintroducesalternativecorporategovernancestructures,allowingtheestablishmentofanauditcommitteecomprisedofdirectorsinlieuofaboardofsupervisorsor
supervisors,toperformthefunctionsanddutiesofaboardofsupervisors.Inaddition,limitedliabilitycompaniesofasmallsizeorhavingasmallnumberofshareholdersmaychoosenottohaveany
supervisor.Weunderstandthatforeigninvestorsusuallysetupacompanyintheformofalimited
liabilitycompanyinthePRC,whichisusuallyawhollyforeignownedenterprise(WFOE)orajoint
venture(JV)havingasmallnumberofshareholders.Therefore,foreign-investedcompaniesmay
consideroptimizingtheircorporategovernancestructurebasedontheirownsituationtoreducecostsandincreaseefficiency.
ItisworthnotingthatthePRCForeignInvestmentLawpromulgatedin2019requiresforeign-investedenterprisespreviouslyestablishedundertheSino-ForeignEquityJointVentureLaw,theSino-ForeignCooperativeJointVentureLawandtheWhollyForeignOwnedEnterpriseLawtoadjusttheir
organizationalformandstructureaswellasoperatingrulesaccordingtothePRCCompanyLawwithinafive-yeartransitionalperiod(thisperiodwillendonDecember31,2024).Thepromulgationand
implementationoftheNewCompanyLawisatajuncturewhenthetransitionalperiodisabouttoexpire.
Therefore,regardlessofwhetheraforeign-investedpharmaceuticalenterprisehas
completedtheadjustmentfollowingtheCompanyLawornot,itneedstoreviewandupdateitscurrentarticlesofassociation,shareholders’agreement/jointventureagreementand
otherlegaldocumentsaccordingtotheprovisionsoftheNewCompanyLaw.
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II.PromulgationofHGRRegulationImplementationRules
Outofconsiderationofbiosafety,nationalsecurity,andsocialandpublicinterest,thePRCgovernmentsupervisesandregulatesthecollection,preservation,andutilizationofhumangeneticresources
(“HGR”)5aswellasprovisionofHGRtoforeign6partiesandotherHGR-relatedactivities.Since1998,the
PRCgovernmentandothercompetentauthoritieshavepromulgatedtheInterimMeasuresonthe
AdministrationofHumanGeneticResources,theRegulationsontheAdministrationofHumanGeneticResources,theBiosafetyLaw,andotherrelevantlawsandregulations,graduallyestablishingtheHGRregulatoryframeworkandsettingupapprovalorrecord-filingproceduresforHGR-relatedactivities
includingthecollection,preservationandutilizationofHGRandprovisionofHGRtoforeignparties.
OnJuly1,2023,thenewlyreleasedImplementationRulesfortheRegulationsontheAdministrationofHumanGeneticResources(“ImplementationRules”)cameintoeffect.TheImplementationRules
furtherclarifythedefinitionofHGR7andthescopeof“foreignparties”8.TheImplementationRulesalsofurthersimplifytheinternationalcooperationadministrativeapprovalandrecord-filingproceduresthatforeign-investedpharmaceuticalenterprisesmaybeinvolvedin.Forexample,theImplementationRulesprovidecertainexemptionsforforeignpartiesfromethicsreview,andsimplifytherecord-filing
procedurefortheprovisionoftheHGRinformationto,oropenutilizationofHGRinformationby,foreignpartiesto“priorreporting”procedure,etc.
Inpractice,whenaforeign-investedpharmaceuticalenterprisecarriesoutclinicaltrialsin
thePRCtoobtainmarketingauthorizationfortherelevantproductsorengagesin
technologylicensing,cooperativedevelopment,commissioneddevelopmentandotherrelevantactivitieswithPRCinstitutions,HGRcomplianceissuesmayariseandspecialattentionshouldbepaidtotheseissues.
III.FurtherClarificationofMAH’sQualityManagementResponsibilities
ThePRCDrugAdministrationLawrevisedandimplementedin2019formallyestablishedthedrug
marketingauthorizationholder(“MAH”)system.Accordingtorelevantlawsandregulations,MAHsshallberesponsibleforthequalityandsafetyofdrugsduringtheirfulllifecycle.
On1March2023,theProvisionsontheSupervisionandAdministrationofDrugMarketingAuthorizationHoldersImplementationoftheMainResponsibilitiesofDrugQualityandSafetyissuedbythePRC
NationalMedicalProductsAdministration(“NMPA”)cameintoforce,requiringMAHstosetupquality
managementdepartmentsstaffedwithqualitymanagementpersonnel,andfurtherclarifyingthespecificrequirementsforMAHsincarryingoutqualitymanagementwork.Drugadministrationauthoritieswill
superviseandinspectthequalitymanagementworkperformedbytheMAHs.InOctober2023,with
regardtocontractmanufacturingofdrugsbyMAHs,NMPAissuedtheAnnouncementonStrengtheningtheSupervisionandAdministrationofContractManufacturingbyDrugMarketingAuthorizationHolders,puttingforwardaseriesofspecificrequirementsonqualitymanagementbyMAHsinrelationtocontractmanufacturing.
Aforeign-investedpharmaceuticalenterprisewhoistheMAHofacertaindrugneedstotakefullresponsibilityforthequalityandsafetyofitsdrug(ifaforeignentityistheMAH,such
foreignMAHshalldesignateaPRCentityasitslocalagenttoperformtheobligationsoftheforeignMAHandbearjointandseveralliabilitywiththeforeignMAH).IftheMAHholdinga
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classBdrugproductionlicenseentrustsathirdpartytomanufacturethedrugs,itshould
payparticularattentiontothequalitymanagementissuesduringtheentrustedmanufacturing.
IV.PromulgationofNewRegulationsonDrugDistribution
FollowingtherevisionofthePRCDrugAdministrationLawin2019,theProvisionsforDrugRegistration
andtheProvisionsfortheSupervisionandAdministrationofDrugManufacturing,havebeensuccessivelyrevisedandpromulgatedastheimplementingregulations.However,theregulationsinthefieldofdrugdistribution(ProvisionsforDrugDistributionLicenseandProvisionsforSupervisionofDrugDistribution),whichwerepromulgatedearlier,arenolongerinlinewithcurrentregulatorythinkingandrequirements.
InSeptember2023,theSAMRissuedtheProvisionsforSupervisionandAdministrationoftheDrugQualityinDistributionandUsage(“Provisions”),updatingtheregulatoryrulesinthefieldofdrugdistribution.TheProvisionswereimplementedon1January2024.
ThenewlyissuedProvisionsreplacetheProvisionsforDrugLicenseandProvisionsforSupervisionof
DrugDistribution,becomingthecoreregulatorydocumentinthefieldofdrugdistribution.TheProvisionssimplifytheadministrationofdrugdistributionapproval,clarifythecross-regionalsupervision
responsibilities,andprovideclearprovisionsontherequirementsforself-ownedwarehousesofdrug
wholesalers,commissionedstorageandtransportation,andself-salesaswellascommissionedsalesbyMAHs.
Foreign-investedpharmaceuticalenterprisesconductingbusinessinthePRCshouldcomplywiththerelevantrequirementsoftheProvisions.Specifically,foronlinedrugsales,onlinetradingplatformsandotheremergingonlinebusinessmodes,theSAMRissuedthe
ProvisionsforSupervisionandAdministrationofOnlineDrugSales,effectiveasofDecember1,2022.Foreign-investedpharmaceuticalenterprisesinvolvedinrelatedbusinessesshouldtakenoteoftheseprovisions.
V.ComplianceRequirementsforAdvertisingContinuetobeDetailed
Duetotheuniquecharacteristicsofpharmaceuticalproductsandmedicalserviceswhichdifferfromothergeneralgoodsorservices,advertisingandpromotionalactivitiesinthehealthcareand
pharmaceuticalindustryshallstrictlycomplywiththerequirementsofthelaw.Inrecentyears,
accompaniedbytheemergenceofawidevarietyofnewadvertisingcampaignsresultingfromthedevelopmentofe-commerceanddigitalmarketingactivities,thePRCgovernmenthascontinuedtorefinetheregulatorysysteminthefieldofadvertisingthroughtheintroductionofrelevantlawsandregulations.
InMarch2023,theSAMRissuedtheMeasuresontheAdministrationofInternetAdvertising,which
comprehensivelyoptimizeandsupplementtheInterimMeasuresontheAdministrationofInternet
Advertisingpromulgatedin2016,expresslyprohibitinganypublicationofadvertisementsformedical
treatments,drugs,medicaldevices,healthfoodandformulafoodsforspecialmedicalpurposesin
disguisedformssuchasintroducinghealthandwellnessknowledge.Furthermore,newlyemerged
popularmarketingmethods,suchaslivestreaming,arealsosubjecttoadvertisingregulationandmustcomplywithrelevantrequirements.
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InMay2023,theSAMRissuedtheMeasuresforExaminationandAdministrationofAdvertisementsofDrugs,MedicalDevices,HealthFoodandFormulaFoodsforSpecialMedicalPurposes(Draftfor
Comments),whichfurthersupplementthecompliancerequirementsfortheadvertisementsofdrugs,
medicaldevices,healthfoodandformulafoodsforspecialmedicalpurposes.Forinstance,itisforbiddentoconcealthepromotionoftheaforementionedproductsasimpartinghealthandwellnessinformationduringlivestreaming;itisalsoprohibitedforspokespersonsinadvertisementstoendorseorcertifytheaforementionedadvertisedproductsduringlivestreaming.Additionally,itoptimizestheexistingrulesofadvertisingreviewandapprovalfortheaforementionedproductsbyadvertisingcensorshipauthorities.Forexample,itclarifiesthatadvertisingreviewisnotrequiredforintroductionanddisplayofproduct
information,specifiedtheexceptionsforanewadvertisingreviewandadjustedthevalidityperiodofadvertisingapprovalnumbers,etc.
WhenconductingpromotionalmarketingactivitiesinthePRC,foreign-investedpharmaceuticalenterprisesshouldpaygreatattentiontowhethercertainpromotionalbehaviorsareconsideredadvertisementswhichthereforemustcomplywithrelevantlawsandregulations.
VI.IntensifyingEnforcementinAnti-Bribery
Inrecentyears,withtheaimofimprovingtheindustryenvironmentandmaintainingfaircompetition,
thePRCgovernmenthascontinuedtofocusoncrackingdownonvarioustypesofbriberyandcorruptionactivities.The“anti-corruptionstorm”in2023hashadamajorandfar-reachingimpactonthewhole
healthcareandpharmaceuticalindustry.OnMay8lastyear,theNationalHealthCommissionofPRC
(“NHC”)andtheNMPA,togetherwithother12ministries,jointlyissuedtheKeyPointsforRectifyingMisconductsinFieldoftheMedicinalPurchaseandDistributionandMedicalServicesin2023;lateronJuly21,theNHC,inconjunctionwiththeNMPAandother8ministries,convenedavideoconferencetodeployaone-yearnationwideconcentratedrectificationagainstcorruptioninthehealthcareand
pharmaceuticalindustry;onJuly28,theCentralCommissionforDisciplineInspectionandtheNational
SupervisoryCommissionconvenedakickoffmeetingwithprefectural-levelauthoritiesofdiscipline
inspectionandsupervision,reiteratingtherequirementsoffocusingonthecadresandkeypersonnel,
insistingonthesupervisionofbothcommittingandacceptingbribes,aswellasconcentratingondealingwithanumberofcorruptioncasesinthehealthcareandpharmaceuticalindustry.Sofar,thisspecial
anti-briberyactionhasmadecertainachievements.
Thisanti-briberyenforcementactionissweeping,coveringthewholeprocessofpharmaceutical
manufacture,supply,distribution,useandreimbursement,withthejointactionofmultipleministriessuchasNMPAandNHC,formingacoordinatedregulatoryandenforcementmechanism.Sincethen,hundredsofleadersandcadresofmedicalinstitutionshavebeeninvestigatedorhavevoluntarily
surrendered,andvariousacademicconferenceshavebeensuspendedorpostponed.Onceagain,theissueofcommercialbriberyinthepharmaceuticalmarketingsectorhasbecomeahottopicinthe
industry.
Thisanti-corruptionactionisanalarmbellaswellasagoodopportunityforpharmaceuticalenterprises
tocarryoutcompliancemanagement.Ontheonehand,foreign-investedpharmaceuticalenterprisesshouldbemorecautiousinconveningacademicconferences,providingcommercialsponsorshipsandothermarketingactivitiestomeetthecompliance
requirements.Atthesametime,ininvestmentandM&Aactivitiesorbusinesscooperation,
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theyshouldalsopayattentiontothecompliancestatusoftargetcompaniesorsuppliers,
andstrengthenexternalcompliancemanagementtoavoidattractingjointliabilityand
compliancerisks.Ontheotherhand,enterprisescouldalsomakeuseofthisopportunitytoconductself-evaluationoftheircompliancemanagementsystem,furtherenhancingtheir
compliancemanagement.
VII.ImprovingLegislationandTighteningofEnforcementintheAnti-monopolyField
2023istheyearwhenthewholeanti-monopolylawsysteminPRCwascomprehensivelyperfected.Tillthebeginningof2024,theSAMRhassuccessivelyrevisedaseriesofanti-monopolyregulations,whichincludesiximplementingrulesandregulationsrelevanttotheAnti-monopolyLaw(2022revision),i.e.ProvisionsonProhibitionofMonopolyAgreements,ProvisionsonProhibitionoftheAbuseofMarket
Dominance,ProvisionsontheReviewofConcentrationofUndertakings,ProvisionsontheAbuseof
AdministrativePowerontheeliminationandrestrictionofcompetitions,ProvisionsontheAbuseofIntellectualPropertyRightsontheeliminationandrestrictionofcompetitions,andRegulationsontheMergerControlFilingThresholds.
Thehealthcareandpharmaceuticalindustryhasalwaysbeenakeyfocusofanti-monopolyenforcement.Theanti-monopolyenforcementinPRCisdevelopingtowardsamoretransparentandhigh-leveltrend,
whichalsoincreasestheriskstoenterprises,especiallyinthehealthcareandpharmaceuticalindustry,
whichiscloselyrelatedtopeople’slivelihood.Accordingtorelevantresearchreports9,sincethe
implementationoftheAnti-monopolyLaw,casesinthepharmaceuticalandhealthcareindustryaccountfor10%ofalladministrativeenforcementcases,makingitoneoftheindustrieswiththehighestamountofanti-monopolyenforcementactivities.Inrecentyears,anti-monopolylawenforcementactivitiesinthePRCpharmaceuticalindustryhavemainlyfocusedontheAPIsfield,whileotherfieldssuchasdrugsandmedicaldeviceshavealsoreceivedincreasingattention,particularlyinthemarketingsector.Theanti-
monopolyenforcementactivitiesmainlytargetatmonopolisticbehaviorswhichdirectlyaffectprices,suchasunfairlyhighpricesandfixedprices,andmanipulatingpricebyrefusingdealsorattaching
unreasonableconditions.SinceFebruary2023,theSAMRandotherprovincialandmunicipalmarket
regulatoryauthoritieshavelaunchedseveralspecialanti-monopolyenforcementactivities,focusingonmonopolisticbehaviorinhealthcareandpharmaceuticalindustryandotherkeyindustries.In2023,
SAMRdisclosedthreebatchesoftypicalanti-monopolyenforcementcasesinthefieldofpeople’slivelihood,ofwhich8wererelatedtothehealthcareandpharmaceuticalindustryandinvolved13pharmaceuticalenterprises.
Inthefuture,anti-monopolyenforcementactivitiesinthePRChealthcareandpharmaceuticalindustry
wouldcontinuetobestrictandrigorous.Becauseoftheheavypenaltiesinasingleanti-monopolycaseandthehighcostofviolatinglaws,foreign-investedpharmaceuticalenterprisesneedtopayextraattentiontothemonopolisticbehaviorssuchasconcentrationofundertakings,
abuseofmarketdominance,ormaintenanceofresalepriceintheirinvestmentandM&A
activitiesaswellasdailyoperationsinPRC,andcarryoutnecessaryanti-monopolyreviewstocertainbusinesspractices.
BasedontheexperienceandobservationsofKing&WoodMallesonsLifeSciences&HealthcareGroup,itisanticipatedthatthePRCgovernmentwillcontinuetofocusonthedevelopmentofthehealthcare
andpharmaceuticalindustryandencourageforeigninvestmentinthePRC.Inthefuture,PRC’s
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healthcareandpharmaceuticalindustrywilldeveloptowardsamorelaw-basedandstandardizedtrend.WheninvestinginthePRC,ontheonehand,foreign-investedenterprisesshouldpaycloseattentiontolegalandregulatorydevelopments,whichwouldhelpensuresuccessfulimplementationofinvestments,M&A,andlicensingtransactions,aswellasmaintainsmoothoperations.Ontheotherhand,experiencedPRClawyersinthehealthcareandpharmaceuticalindustrycouldalsoassistforeign-investedenterprisesinmanaginglegalrisksrelatedtoinvestment,M&A,operation,andexit.Duetospaceconstraints,this
articleonlyprovidesageneraloverviewofthePRC’shealthcareandpharmaceuticalindustry’slegalenvironmentfromlastyeartothepresent.Pleasefeelfreetocontactusifyouhaveanyqueries.
Footnotes:
1
ReferringtoChinaM&A2023Mid-YearReviewandOutlookpublishedbyPWC.
2ReferringtotheCatalogueofEncouragedForeignInvestmentIndustries(2022)issuedbythePRCNationalDevelopmentandReformCommissionandthePRCMinistryofCommercewhichcameintoforceonJanuary1,2023.
3
ReferringtotheGuidelinesregardingFurtherOptimizingtheForeignInvestmentEnvironmentandIntensifyingEffortsto
AttractForeignInvestmentsissuedbytheStateCouncilandcameintoforceonJuly25,2023.
4
AccordingtotheProvisionsoftheStateCouncilontheImplementationoftheRegistrationandAdministrationSystemof
RegisteredCapitalunderthePRCCompanyLaw(DraftforComments)releasedbytheSAMRonFebruary6,2024,existing
companyshall,duringathree-yeartransitionperiod(fromJuly1,2024toJune30,2027),adjusttheremainingcapital
contributionperiodtowithin5years,andtheremainingcapitalcontributionperiodfollowingtheadjustmentshallnotexceedfiveyearsfrom1July2027.IftheremainingcapitalcontributionperiodislessthanfiveyearsbyJuly1,2027,
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