code of business conduct - idorsia
Post on 09-May-2022
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The main provisions of the code are:• EmployeesofIdorsiaanditsworldwideaffiliatesareresponsible
for always demonstrating honesty, integrity, and respect in their workactivities,obeyingapplicablelawsandregulations,andadheringtoIdorsiapoliciesandprocedures,includingthisCodeofBusinessConduct.
• Supervisorsareaccountableforcomplianceandbusinessconductinthegrouptheymanage.
• Departmentheadsareaccountableforcomplianceandbusinessconductintheirfunctionaloroperationalarea.
• Idorsiaiscommittedtoaworkenvironmentthatencourageshonestdiscussionofissuesandconcernsaboutlegalcompliance,Companypolicy,andbusinessconduct.
“The Code”Idorsia’sCodeofBusinessConduct(“theCode”)establishescorporatestandardsofbehaviorforallIdorsiaemployees.BymaintainingthestandardsofconductdescribedinthisCode,youenableIdorsiatofulfillitscommitmenttothehighestintegrityinbusinessconduct.
Codeofbusinessconduct
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientificintegrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
How should i use the code?While all Idorsia employees are expected to exercisegoodjudgment,itisnotalwayseasytodeterminewhatis“right”dependinguponthecircumstances.Idorsia’sCodeofBusinessConductisintended to help employees arrive at therightdecision,providingguidanceinsituationsthatmayposequestionsorrequiredifficultjudgments.
• Employeeswholearnoforsuspectalegal,ethical,orpolicyviolationmustraiseitwiththeirsupervisor,ortheirlocalcompliancechampion,ortheCorporateComplianceOffice,orthroughtheGlobalComplianceHelplineat0800110007(forSwitzerland),+41588440106foroutsideSwitzerland,orcompliance@Idorsia.com.
• Idorsiadoesnotpermitmeasuresagainstanyonewho,ingoodfaith,raisesissues,concerns,orallegationsofcomplianceviolationsorunethicalconduct.
• Idorsiawillinvestigateallallegationsofmisconduct,includingviolationsofthisCodeand,whereappropriate,takedisciplinaryandcorrectiveaction,uptoandincludingterminationofemployment.
Whilecoveringawiderangeofbusinesspracticesandprocedures,thisCodecannotanddoesnotcovereveryissuethatmayarise,oreverysituationwheredecisionsmustbemade;rather,itsetsforthkeyguidingprinciplesthatrepresentCompanypoliciesandestablishedconditionsforcontinuedemployment.
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientificintegrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Legal compliance & ethical practices
Acting with honesty, integrity, and respect isthefoundationuponwhichthisCodeisbuiltandhowIdorsiaconductsbusiness.Inadditiontothisguidingprinciple,obeyinglawsandregulations,bothinletterandinspirit,iscriticaltooursuccess.WhileIdorsiaemployees are not expected to know the detailsofeverylaworregulation,itisimportant that employees are aware of the corerequirementsestablishedinthisCodeand know when to seek advice from their supervisorortheCorporateComplianceOffice. Idorsia strives to provide fair and competitivewagestoouremployeesbasedonperformanceandethicalconductandtoprotectouremployeesfromunsafeorimproperworkingconditions.
Idorsiaisalsocommittedtoqualityinthemanufacturing,packaging,andtestingofitsproducts.Toensurepatientsafety,itstrivestomeetorexceedapplicableregulatoryauthorityrequirementsforcurrentGoodManufacturing,ClinicalandLaboratoryPractices(cGXPs).
Idorsiaisrequiredtocompileandmaintainnumerousrecordsandtofilereportsandapplicationswithvariousgovernmentagencies.Virtuallyalloftheseagenciesoperateunderlawswhichmakeitacrime-punishablebyfinesand/orimprisonment-toknowinglysubmitfalseorincompleteinformation,tofailtosubmitrequiredinformation,ortofailtosubmitinformationwithinarequiredtimeperiod.CarelessnessalonecanconstituteanoffenseinsomeinstancesandcancallintoquestionIdorsia’scompetencyandgoodfaith.
Accordingly,Idorsiarequiresthatallemployees who prepare information, records,orsubmissionsforgovernmentalagencies, or who otherwise deal with suchagencies,dosodiligently,accurately,completely,andwithabsoluteintegrity.
ToensureIdorsiaemployeesarepreparedtoperformtheirdutieseffectivelyandincompliancewithourqualityrequirements,theCompanyprovidesappropriateinstructionandtraining.
Eachdepartmentheadisresponsibleforensuringthatemployeeswithintheirgroupcompleteallrequiredtraining.Employeesareexpectedtocompleteprescribedtraining and acknowledge, in writing, that theyunderstandandwillcomplywithrelevantlaws,rulesandregulations,aswellasCompanypoliciesandprocedures.
Laws and regulations with which idorsia must comply include, among others, those that address:• The research, development, pharmacovigilance,manufacturing,marketing,promotion,anddistributionofpharmaceuticalproducts
•Laborandemploymentlaws•Securitieslaws•Anti-competitive(anti-trust)laws• Privacy laws•CorporateGovernancelawsrelatingtodutiesowedbycorporatedirectorsandofficers
Compliancewithlaws®ulations
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Interactionswithvendors,customers,competitors,collaborators,healthcareprofessionals(HCPs),patients,andgovernmentofficialsmustalwaysbelegal,transparent,andethical.Offeringoracceptinganinducement(financialorotherwise)inexchangeforthepurchaseofand/orrecommendationtopurchaseaproductorserviceisinappropriateandprohibited.
Gifts and entertainmentNon-Governmental, Non-HCP Business AssociatesWhileproviding,hosting,oracceptingabusinesscourtesy,suchasamodestmeal,giftand/orentertainment,maybeacceptableundercertaincircumstances,thebusinesscourtesymustbereasonableinnature,permissibleunderapplicablelawsandregulations,andcompatiblewithindustrystandardsandlocalcustoms.Toavoideventheappearanceofaconflictofinterest,employeesmustexercisecaution,honesty,andgoodjudgment.Inuncertaincircumstances,orifthereisanydoubt,thesituationmustbepresentedtoasupervisor,whohastheultimateresponsibilityandauthoritytoapprovetheofferingoracceptanceofabusinesscourtesy.
Idorsiaemployeesarestrictlyprohibitedfromrequestingbusinesscourtesiesofanykind.Ifrefusalofagiftthatexceedsnormalbusinesscourtesywouldoffendthegiver,thegiftshouldbeacceptedandthenforwardedtotheCorporateComplianceOfficeforappropriatehandling.
Businesspractices
Examples of prohibited “inducements” to secure business may include:• Gifts,entertainment,orhospitalitythatis
excessive or lavish• Donationstothirdpartiesattherequest
or direction of another party• Paying travel expenses or accommodations foranindividualwithoutalegitimatebusinesspurpose
• Accepting or providing a gift, money, cash equivalent,orotheritemofvalue
• Providing free goods or services• Paymentstogovernmentofficialstoinfluencegovernmentalactions
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
HCPs, Business AssociatesOfferingbusinesscourtesiestoHCPsisregulatedinmanycountriesbylawand/orindustrycodes,whichareconcernedwiththepotentialconflictofinterestcreatedbyindustry’sinfluenceonHCPs.Toaddresstheseconcernsandensureourfocusremainsonpatientcare,Idorsiaiscommittedtoonlyprovidingbusinesscourtesiesconsistentwithlocalcountryrequirements,andforthepurposeoffacilitatingpatientorHCPeducation.
Forthisreason,businesscourtesiesmayneverbeprovidedwiththeintentofinappropriatelyinducinganHCPtoprescribe,purchase,orrecommendanyproducts.
Government OfficialsManycountrieshaveanti-briberylawsregulatingtheofferingofbusinesscourtesiestogovernmentemployeesandrepresentatives(collectively,“governmentofficials”).Idorsiapolicyprohibitsoffering,promising,paying,orgivinganythingofvalue,directlyorindirectly,toagovernmentofficialforthepurposeofundulyinfluencingagovernmentaction.Prohibiteditemsofvaluemayinclude,butarenotlimitedto,cashpayments,meals,personalgifts,travel,andentertainment.
Around the world there are wide-ranging interpretations of “normal business practices”. What is considered a customary business courtesy in one country may be viewed as improper in another. What does that mean for idorsia employees?Idorsiaemployeesmustnotprovideanypaymentorbenefitofanykindorprovideanythingofvaluetogainanimproperbusinessadvantageregardlessofthecountryinwhichtheconducttakesplace.Before making any payment or providing anythingofvalue,seekguidancefromyoursupervisor,yourlocalcompliancechampion,ortheCorporateComplianceOffice.
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Anti-competitive practices and fair dealingIdorsiaiscommittedtoprotectingfreeenterprisethroughcompliancewithapplicableanti-competitionlawsandregulations.ViolationoflawsandregulationsdesignedtoensurecompetitionandfreeenterprisecanhaveseriousconsequencesfortheCompanyandforindividuals.Belowaresomeexamplesofactivitieswithimportant anti-competition implications:
•Agreeingwithcompetitorstofixpricesorothertermsofsale•Boycottingcertainsuppliersorcustomers•Dividingsalesopportunitieswithcompetitorsbyterritoryorproductline
•Agreeingwithdistributorsonmandatoryresalepricing• Price discrimination• Disparaging, misrepresenting, or harassing a competitor
Anti-competitionissuesarecomplexandshouldbereferredtotheGroupGeneralCounsel.Idorsiaseekstooutperformcompetitionfairlyandhonestlythroughsuperiorperformanceandneverthroughdubiousorillegalbusinesspractices.Misappropriatingproprietaryinformation,possessingtradesecretinformationthatwasobtainedwithouttheowner’sconsent,orinducingsuchdisclosuresbypastorpresentemployeesofothercompaniesisprohibited.
International tradeEmployeeswhosejobfunctionsinvolveinternationaltrademustbeknowledgeableofandcompliantwiththeapplicablelegalrequirementsandrestrictions,suchastradeembargoes,boycotts,import/exportrestrictions,localimportationcustomspracticesandrequirements,andothertradeandtaxationlawsandregulations,aswellasrelevantCompanypolicies.Forquestionsrelatingtomattersofinternationaltrade,employeesmustconsulttheirsupervisorortheGroupGeneralCounsel.
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
AconflictofinterestexistswheneveranindividualrepresentingIdorsiausestheirpositiontoengageinconductthatcompromises,orappearstocompromise,theirabilitytomakeanimpartialbusinessdecisiontotheultimatebenefitoftheCompany.
Idorsiaemployeesarestrictlyprohibitedfromengaginginanyactivitiesthatmayresultinaconflictofinterest,unlesspreviouslydisclosedtotheirsupervisorandauthorizedbytheCorporateComplianceOffice.
Itisnotpossibletodescribeeverysituationoroccurrencethatcouldleadtoaconflictofinterest.Therefore,employeesmustavoidanycircumstancethatcouldevenleadtotheappearanceofimpropriety.
What are some ways to avoid conflicts of interest?Idorsiaemployeescanavoidconflictsofinterestbyalwaysbasingbusinessdecisionsonnormalbusinessconsiderationssuchasquality,cost,availability,reputation,andotherfactorsbearingdirectlyontheproductorservice.Idorsiaemployeesmustnotusetheirpositiontodirectlyorindirectlybenefitthemselvesorothers(includingbutnotlimitedtorelativesorcloseassociates).
Decisions and actions involving Idorsia and itsbusinessmustalwaysbebaseduponwhatisinthebestinterestsofIdorsia.Ifyouareuncertainwhetheraconflictofinterestmightexist,contactyoursupervisorortheCorporateComplianceOfficebeforemakingadecisionorengaginginanactivity.
Conflictsofinterest
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Somecommonconflictofinterestsituationsmayinclude:
Financial interestsHolding,byanIdorsiaemployeeordirectfamilymember,adirectorindirectfinancialinterestofmorethan5%inavendororcustomer.
EmploymentBeingemployedby,providingconsultingservicesfor,orservingasanofficerordirectorofanothercompany,includingbutnotlimitedtocompetitors,customers,suppliers,orvendorstoIdorsia.
Business and financial transactionsConductingIdorsiabusinesstransactionswith a company that employs a family memberofanIdorsiaemployee.Enteringintopersonalfinancialtransactionswith an employee or representative of a customer,competitor,orvendor.
Corporate opportunitiesUsingnon-publicinformationacquiredasaresultofemploymentwithIdorsia.TakingadvantageofbusinessopportunitiesthatrightfullybelongtoIdorsia.SellingservicesorproductsthatcompetewithIdorsia.
Non-business activitiesParticipatingintradeassociation,non-profit,orothernon-businessactivitiestothedetrimentofperformingIdorsiajobduties.
Personal use of company property and informationUsingordivertingCompanypropertyfornon-businessactivities.Note:Theaboveexamplesareprovidedforillustrationanddonotrepresentacomprehensive listing of all potential conflictofinterestsituations.
The spouse of an idorsia employee has an ownership interest in an advertising company idorsia is considering using. The idorsia employee does not have any decision-making responsibilities as to which vendor is selected. Does this present a conflict of interest?No.Thisisapotentialconflictofinterest.Importantly,anyactualorpotentialconflictofinterestoreventheappearanceofaconflictofinterestcoulddamageanemployee’sreputationorthatoftheCompany.TherelationshipmustimmediatelybedisclosedtoyoursupervisorortotheCorporateComplianceOfficeforadvice.
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Itisrecognizedthatasamemberofahighlyregulatedandpubliclyvisibleindustry,certainpoliticalinitiativesmayaffectIdorsiabusiness.Idorsia’spoliticalactivitieswilloccuronlythroughparticipationinandmembershipofindustryassociations(e.g.,Interpharma,PhRMA).TheChiefExecutiveOfficermustapproveconsultationandhiringofpoliticallobbyistsaswellasactiveorpassive participation in any associations, parties, or other interest groups.
Directsupport(financialorotherwise)ofpoliticalpartiesorindividualcandidatesforpublicofficebyIdorsiaisprohibited.Idorsia employees, in their company capacity, cannot make any loan, donation,contribution,orpaymenttoapoliticalparty,candidate,orpoliticalactioncommittee,fororonbehalfoftheCompany,oranyprojectordevelopmentinwhichtheCompanyisengaged,norshalltheycausetheCompanytoreimburseanyindividualwhoprovidessuchsupport.(NothingcontainedinthisPolicyshallprohibitIdorsiaemployeesfromtakinganyoftheaboveactionsasaprivatecitizen,inhisorhername,providedthattheactionisexclusivelyontheirown accord and is not an indirect means of accomplishing one of the prohibitedactions.)
Forquestionsrelatingtopoliticalcontributionsandactivities,consultwithyoursupervisor,yourlocalcompliancechampion,ortheCorporateComplianceOffice.
Politicalcontributions&activity
The Code
> Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
The workplace
Interactions with othersIdorsiaisfirmlycommittedtoprovidingequalopportunityandapositiveworkingenvironmentinallaspectsofemployment.Idorsiaemployeesmusttreateachotherandourthirdpartystakeholderswithrespectatalltimes.
Discriminationbasedonrace,color,religion,nationalorigin,sexualorientation,gender,age,disability,oranyotherlegallyprohibitedbasis,isprohibited.Thisappliestoallemploymentpractices,includingrecruiting,hiring, pay, performance reviews, training and development, promotions, and other termsandconditionsofemployment.
Similarly, Idorsia does not permit any form of harassment.Thisincludesanyabusiveconduct,includingverbal,non-verbal,orphysicalconductthat demeans or shows hostility toward an individual.
Policy against retaliationRetaliationorothermeansofcountermeasuresareprohibitedagainstanyemployee who has made a complaint in
The work environment
What behaviors might be considered harassment?Behaviorthatmightbeconsideredharassment may take many forms and canincludewords,gestures,oracts.Examplesincludejokesrelatedtorace,religion, ethnic origin, or other personal characteristics,teasingthatcausessomeonetofeelhumiliated,bullying,displaysofinappropriatematerial,unwelcomeflirtingorsexualadvances,andthreatsofviolence.
Beawarethatbehaviorthatis“acceptable”inonecountrymaynotbeacceptableelsewhere.
goodfaithaboutdiscrimination,harassment,sexualharassment,wrongdoingandviolationsoflaw,orCompanypoliciesorprocedurestoappropriateCompanymanagers, or who has cooperated in the investigationofsuchacomplaint.
RetaliationincludesanyemploymentdecisionorotherconductmadewiththeintenttopunishanemployeeforsubmittingacomplaintorassistinginaCompanyinvestigation, as well as any decision or conductthatmighthavediscouragedanemployeefromsubmittingacomplaintorcooperatinginaninvestigation.
Health, safety, and the environmentIdorsiarecognizesthatexcellenceinhealthandsafety(“H&S”)performanceisintegraltoanefficientandsuccessfulbusiness.IdorsiawillconstantlypursuehighstandardsofH&Sperformanceinallitsactivities.
AllemployeesmustcomplywiththeCompany’senvironmental,health,andsafetypoliciesandprocedures,aswellaslocallawsandregulations.Employeesmustalsoattendrequiredtrainingandperform
theirjobsinamannerthatpromotesasafeand healthy workplace while also preserving andprotectingtheenvironment.
The Code
Legal compliance & ethical practices
> The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
AllIdorsiafacilitiesandequipmentareIdorsiaproperty.EmployeesareresponsiblefortheappropriateuseofIdorsiafacilities,equipment,andservices.Anysuspectedincidentoftheftorfraudmustbereportedimmediatelyforinvestigation.
Employees are not permitted to access anotheremployee’sofficeorcomputerunlesspriorpermissionisreceivedfromthatemployeeorfromasupervisorininstanceswheresuchactionisnecessarytoconductCompanybusiness.ItisagainstCompanypolicytouseordivertanyCompanyproperty,includingservicesofotheremployeesandCompanyinformation,forpersonaladvantageorbenefitorforuseinnon-Idorsiabusinessactivitiesornon-businessactivitiesunrelatedtotheCompany.
Idorsiacomputers,communicationsdevices/equipment,andnetworksmayonlybeusedinaccordancewithCompanypolicyandmayneverbeusedtoaccess,receive, or transmit material that is illegal orinappropriate.IfsendingproprietaryorconfidentialinformationtopersonsoutsideoftheCompany’semailsystemorif receiving information from persons that aretransmittingsuchinformationviaanon-company email or data transfer system, theCompany’sITsafetyprotocolsandprecautionsmustbeobserved.
BusinesstravelmusthavealegitimatebusinessrationaleandbeconductedinsuchamannerastooptimizethebenefitofthetriptotheCompany(e.g.,maximizeuseofemployeetimespentworkinguponCompanybusinesswhilealsousingCompanyresourcesefficiently).
Idorsia property & resources
Equipmentandelectroniccommunications
Travel
Protecting company property and resources:•HandleCompanyassetsandequipmentcarefullytominimizelossanddamage
•UseCompanyassetsforlegitimatebusinesspurposesonly
•SecureCompanyequipmentandinformationsuchaslaptopsorworkfileswhen traveling or at other times when theyareoutsidetheoffice
•FollowCompanypoliciesandinstructionsregardinguserIDsandpasswords
•NotifytheGlobalInformationTechnology(IT)departmentandlinemanagementimmediately in the event of loss or theft of equipment
•DonotintroducesoftwareontoCompany-providedequipmentwithouttheadvanceapprovaloftheIdorsiaGlobalITdepartment
The Code
Legal compliance & ethical practices
> The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Data and information policies
Companyrecords,suchaslaboratorynotebooks,productinformation,financialinformation,andgovernmentfilings,mustbeanaccurateandverifiablerecordofallactivitiesandtransactions.Alldatamustberecordedandmaintainedaccordingto Idorsia record retention policies and procedures.
TheCompany’sprocessesshallbedesignedtoensurereasonableassuranceofeffectiveandefficientoperations,compliancewithlawsandregulations,andthesafeguardingofassetsandreliablefinancialinformation(Sarbanes-OxleyActof2002).Idorsiaemployeesentrustedwithcontrolovertheseassetsandfinancialinformation,shall,throughtheuseandmaintenance of controls, implement and upholdanenvironmentinlinewithIdorsia’scomplianceFramework.Recordingfinancialtransactions follows generally accepted accountingprinciplesintheUnitedStates(USGAAP)andapplicablelocallaw.Financialinformationshallbepresentedfairly,inallmaterialrespects,reflectingthefinancialpositionoftheCompany.Maintainingundisclosedorunrecordedfundsorassets
Record keeping
andliabilitiesestablishedforanypurposeisprohibited.Financialinformationshallbereadilyunderstandablebyusersandrelevant to the economic decision-making needsofusersinallmaterialrespects.Theinformationfiledwith,orsubmittedto,anyregulatorybody,aswellassharedthroughinternalandexternalcommunicationchannels,hastobereliableintermsofcompleteandfairpresentation.
The manner in which information is recorded reflectsontheCompany’sscientificandbusinessintegrity,andallemployeesareresponsibleforadheringtothehigheststandardsoftheirprofession.Reportsandinterpretationofdataandresults(includingfinancialresults)mustbedoneingoodfaithandinsuchamannerastopreventmisleadingthereader,ordisguisingormisrepresentinganyaspectofatransaction.FalsificationofrecordsormisrepresentationoffactsisprohibitedbytheCompany.
Businessrecordsandcommunicationsoftenbecomepublicandthereforethecontentofsuchrecordsandcommunicationmustbeprofessional,precise,andaccurate,and
may not contain exaggeration, derogatory remarks,guesswork,orinappropriatecharacterizationsofpeopleandcompanies.Thisappliesequallytoelectroniccommunications(suchasemail),internalmemos,andformalreports.
Companyrecordsmustbemaintained,stored and, when appropriate, destroyed inaccordancewiththeCompany’srecordretentionpoliciesandSOPs,andincompliancewithapplicablelawsandregulations(e.g.,drugregulatory,environmental, tax, employment, and trade regulations). Undercertaincircumstances,suchaslitigationorgovernmentalagencyrequests,theCompanymayberequiredtopreservedocumentsandinformationbeyondtheirnormalretentionperiod.
Tounderstandwhichrecordsmustbepreserved,orifaquestionarisesastotheinterpretation of a records and information retentionpolicy,theGroupGeneralCounselshouldbeconsulted.
The Code
Legal compliance & ethical practices
The workplace
> Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Intellectual propertyProtectingIdorsia’sintellectualpropertyis essential to maintaining a competitive advantage.Idorsiaemployeesareexpectedtoestablish,support,maintain,anddefendtheCompany’sintellectualproperty(includingbutnotlimitedtopatents,patentapplications, trade secrets, trade names, trademarks,servicemarks,andcopyrights)ina manner that protects the highly sensitive natureoftheinformationanditscommercialvaluetoIdorsia.
ConfidentialityConfidentialinformationincludesinformationaboutIdorsiaoperations,performance,technology,products,oremployeesthathasnotbeenpubliclydisclosedbyanauthorizedspokespersonoftheCompanyorisnotavailablefrompublicsources.Protectingconfidentialinformationis critical to Idorsia’s competitive edge and is everyemployee’sresponsibility.
Information management
Types of confidential information include:•Researchandscientificdata•Clinicalstudyinformation• Technical designs and processes•Manufacturingdesignsandprocesses• Financial records and data•Marketingandbusinessplans•Unpublishedpatentapplications•Informationthatwouldenablea
competitor to gain a competitive advantage
•InformationthatmayinfluenceIdorsia’ssharevalue
Confidential information that belongs to third partiesProviding Idorsia employees with informationaboutothercompaniesisacceptableonlywhentheinformationisobtainedlawfully(e.g.,throughthepublicdomain).Idorsiaemployeesarenottouse
ordiscloseanothercompany’sconfidentialinformationunlessitwaslegallyobtainedbyIdorsia.ConfidentialinformationrightfullyprovidedtoIdorsiamustbeprotectedandmaynotbeusedordisclosedbyanIdorsia employee to any other party except accordingtothetermsunderwhichitwasprovided.
Idorsiaemployeeswhoareofferedorcomeintopossessionofinformationbelongingtoanothercompanyoraboutanothercompany,andwhoareunsureofitsstatus,orbelieveitmaybeconfidential,shouldconsulttheGroupGeneralCounsel.
The Code
Legal compliance & ethical practices
The workplace
> Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
PrivacyIdorsia is committed to protecting the privacy and integrity of personalinformationinallbusinessactivities.Insofarasitislegallypermissible,theCompanymaycollectpersonalinformation;however,itwillonlycollectsuchinformationforlegitimatebusinesspurposesandretainitonlyaslongasisnecessaryorrequiredbylaw.Inaddition,Idorsiatakesprecautionstosafeguardthesecurityof personal information when it is collected, processed, stored, andtransferred,andwillprovidenoticeandobtainconsentpriortoobtainingpersonalinformation,consistentwithapplicablelawsandregulations.
What is personal information?Personalinformationisanyinformationthatcanbeused,aloneorincombinationwithotherinformation,toidentifyaspecificindividual.Itincludessuchinformationasanindividual’sname,birthdate,gender,homeandbusinessaddresses,socialsecuritynumber,identitycard/passportnumbers,driver’slicensenumber,financialaccountandcreditcardnumber,picture,relatives,telephonenumber,emailaddress,andotherdocumentorelectronicidentifiers.
Insider tradingAllnon-publicinformationabouttheCompany(oranothercompany)mustbeconsideredconfidentialinformation.Confidentialinformationthatcouldaffectthepriceofastock(Idorsia’soranothercompany’s)orcouldbeconsideredimportantbyinvestorstradinginastockiscommonlycalled“insideinformation”.Theuseof“insideinformation”forpersonalfinancialbenefitorto“tip”otherswhomightmakeaninvestmentdecisiononthebasisofthisinformationisillegal;doingsocanresultinfinesandcriminalprosecutionbothforthepersonwhotradesandforthepersonwhodivulgestheinformation.
“Inside information” is material, non-public information that investors would consider relevant to making an investment decision.Examplesinclude:•Ongoingnegotiationsofamerger,acquisition,licensing,orsimilar
transaction•Approvalofnewproducts•Entryintosignificantnewcontracts• Sales of assets•Changesinmanagement• Earnings statements or forecasts
The Code
Legal compliance & ethical practices
The workplace
> Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
A joint venture partner with whom an idorsia employee is working disclosed that they are on the verge of a major scientific breakthrough. Can the idorsia employee purchase stock in our joint venture partner?No.anIdorsiaemployeecannotpurchasethisstockuntilthefirstbusinessdayaftertheinformationisknowntothepublic.Justasimportantly,theIdorsiaemployeecannot provide this information to any other person(includingbutnotlimitedtohis/herspouse,children,relatives,friends,orcloseassociates)whomightdirectlyorindirectlybenefitpersonallyfromthisconfidentialinformation.
There are very strict laws regarding the useofnon-publicinformationaboutpubliccompaniesthatincludebothcivilandcriminalpenalties.Whenindoubt,donottakeanyactionuntilyouhavediscussedthematterwithamemberoftheIdorsiaLegalDepartment.
To avoid even the appearance of trading on inside information, certain Idorsia employees arerestrictedtospecifictimesinwhichtheycantradeinIdorsiastock.EmployeeswhobelievetheymaybesubjecttothesetradingperiodsorhavequestionsaboutaspecificsituationshouldconsultwiththeGroupGeneralCounselbeforetrading.
RelatedIdorsiaPolicies:POL-000026:InformationTech-nology(IT)AcceptableUse,POL-000071:ProtectionofPersonalData,POL-000048:GlobalCorporatePolicyandProcedureonInsiderTrading
The Code
Legal compliance & ethical practices
The workplace
> Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Clinicalandscientificintegrity
ResearchintegrityisfundamentaltothescientificprocessandtoIdorsia’sabilitytobringnovelproductstomarket.
Idorsia employees are expected to protect the integrity of the research and developmentprocessbyensuringthatallresearch,includingbutnotlimitedtonon-clinical and clinical development, isconductedaccordingtoallapplicablelawsandregulationsandtothegenerallyacceptedstandardsofthescientificcommunity.
Scientificmisconductisprohibited.Examplesofscientificmisconductincludebutarenotlimitedtofabrication,falsification,orplagiarisminproposing,conducting,orreportingresearch.Scientificmisconductdisregardstheintellectualcontributionsandproperty of others, impedes the progress of research,andcorruptsthescientificrecord.
Idorsia is committed to the appropriate useofitsproductsandrecognizestheimportanceofprovidingHealthcareProfessionals(HCPs)withthecriticalinformationthattheyneedtomakefullyinformedprescribingdecisions.
ForthepurposesofthisCode,anHCPisany person or entity that interacts directly with patients and has a role in the diagnosis or treatment of the patient, or is licensed andpermittedbylawtoprescribedrugsformedicaluse,orisinapositiontoarrangefororrecommendthepurchaseorprescriptionorformularyplacementofanyCompanyproduct.
InteractionsandcommunicationsundertakenonbehalfofIdorsiamustbefocusedoninformingHCPsabouttheCompany’sproducts,providingscientificandeducationalinformation,andsupportingmedicaleducation.SinceIdorsiaprovidesinformationthroughvariouschannels,itis
critical that promotional interactions and communicationsareinfullconformitywithapplicableapprovedproductlabelingandmeet the highest professional, marketing, andpromotionalstandards.
All promotional activities and interactions withHCPsmustbeconductedinamannerthatisfairlybalanced,scientificallyrigorous,andcompliantwithapplicablelawsandregulations.ThemarketingandpromotionofproductsforanunapproveduseisillegalandisprohibitedbytheCompany.Furthermore,itisCompanypolicytocomplywithallapplicablelawsandregulationsprohibitingtheofferingorgivingofkickbacks,bribes,orotherimproperinducementstoHCPs.AllrepresentativeswhoareemployedbyoractonbehalfofIdorsiaandwhovisitHCPsmustreceivetrainingaboutapplicablelaws,regulations,industrycodesandCompanypolicies governing appropriate interactions withHCPs.
ScientificintegrityInteractions with healthcare professionals & promotional activities
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
> Clinical & scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Patientsafety,throughtheoptimalperformanceandqualityofproducts,isfundamentaltoourCompany’smission.Idorsiatakesseriouslyitscommitmenttoassurethatourproductshaveandmaintainanacceptablerisk-to-benefitprofilewhenusedinaccordancewiththeproductlabelingandgoodmedicalpractice.TheCompanyperformsextensiveandrobustnon-clinicaland clinical testing to identify the safety andtolerabilityprofileofproductsand,onceapprovedforuse,theproductsarecontinuouslymonitoredthroughtheuseofpost-marketingsurveillanceandspontaneousreportsfromprescribersandconsumers.ItistheresponsibilityofallIdorsia employees to promptly report any adversedrugexperiencesthattheybecomeawareofthatcouldbeassociatedwithanIdorsiaproducttotheCompany’sGlobalDrugSafetyDepartment.
An adverse drug event/experience is defined as any unfavorable and unintended sign, symptom, or disease associated with the use of the product irrespective of causal relationship.Italsoincludes:•Aproductqualitydefect•Exposureduringpregnancyorlactation•Misuse,abuse,oroverdose•Medicationerrors(e.g.,dispensingerrors,maladministration,etc.)
•Overdose(whetherintentional,accidental,orprescribed)
•Occupationalexposureasaresultofone’s professional or non-professional occupation
•Reportsofsuspectedfalsifiedproducts• Reports on any transmission of an infectiousagentviatheproduct/s
•Drug-drugordrug-foodinteractions• Withdrawal symptoms•Lackofeffectorworseningofapre-
existing condition•Anunintendedbeneficialeffect
Monitoring the safety, performance, &qualityofproducts
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
> Clinical & scientific integrity
Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Animal welfare
Wheneverpossible,Idorsiaiscommittedtothedevelopmentanduseofscientificallyvalidated alternative testing methods that donotutilizeanimals.TheCompanyworkswithregulatoryauthoritiestoincreasetherecognition and acceptance of alternative models that will not compromise patient safetyortheeffectivenessofmedicinesunderdevelopment.
Inthosecircumstanceswhenitisnecessarytouseanimalstoconductvitalresearch,Idorsiaacknowledgesitsresponsibilitytoensurethatanimalsincludedinstudiesconductedonitsbehalfaretreatedwithrespectandwithahighlevelofhumaneandethicalconcern.
Treatment of animals
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
> Animal welfare
Personal responsibility
Reporting, investigation, & enforcement
Personalresponsibility
IdorsiaemployeesmustworktopreventviolationsofthisCode.TheCompanyrecognizesthatinsomeinstancesitmaybedifficulttodeterminethecorrectanswertoaparticularsituation.SinceeverysituationthatwillarisecannotbeanticipatedandaddresseddirectlyinourCodeofBusinessConduct,itisimportanttorememberthatthereareresourcesavailabletoassistemployees.Thefollowingpointsshouldbekept in mind:
•Askyourself:WhatexactlyamIbeingaskedtodo?Doesitseemunethical,illegal, or improper?
Personalresponsibility
•Askfirst,actlater:Ifyouareunsureofwhattodoinagivensituation,discusstheproblemwithyoursupervisor,oramemberoftheHumanResourcesorLegaldepartments,yourlocalcompliancechampion,ortheCorporateComplianceOffice.Thisisthebasicguidanceforallsituations.
•SeekhelpfromotherCompanyresources:Incaseswhereyoufeelitisuncomfortabletodiscussanissuewithyoursupervisor,consultwithamemberoftheHumanResourcesorLegaldepartments,yourlocal compliance champion, or the CorporateComplianceOffice.Ifyouwishtoremainanonymous,usetheCompany’sGlobalComplianceHelplineat0800110007(forSwitzerland),+41588440106foroutsideSwitzerland,orcompliance@Idorsia.com.
•YoumayreportCodeviolationsinconfidenceandwithoutfearofretaliation.Ifyoursituationrequiresthatyouridentitybekeptsecret,youranonymitywillbeprotectedtotheextentthatitisfeasible.TheCompanydoesnotpermitretaliationof any kind against employees for reports ofCodeviolations.
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
> Personal responsibility
Reporting, investigation, & enforcement
Reporting, investigation & enforcement
AnyemployeewhoreasonablybelievesthattherehasbeenaviolationofthisCodemustreportitimmediatelytotheirsupervisor,theirlocalcompliancechampion,ortheCorporateComplianceOffice,orthroughtheCompany’sanonymousGlobalComplianceHelpline.
IftheviolationisreportedtotheComplianceOffice,itwillpromptlyinvestigatethematter.Theinvestigationwillbehandleddiscreetlyandtheinformationwillbedisclosedtoothersonlyona“needtoknow”basisand/orasrequiredbylaw.Therewillbeno adverse action taken against employees who, in good faith, report violations of this CodeofBusinessConductorwhoparticipateintheinvestigation.IftheinvestigationleadstotheconclusionthataviolationofthisCodehasoccurred,theCompanywilltakeappropriatecorrectiveaction.
Reporting/investigationprocedures
What types of issues should be reported in accordance with this code of business conduct?Examplesofissuesinclude:•Misconductregardingsalesandmarketing
practices•Fraudulentfinancialreporting• Insider trading•Harassmentordiscrimination•Disclosureofconfidentialinformation•Environment,health,andsafetyissues• Data privacy violations
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
> Reporting, investigation, & enforcement
Asanalternativetotheproceduresdefinedabove,anyemployeewhoreasonablybelievesthattherehasbeenaviolationofthisCodecausedbyquestionableaccounting,financialorauditingmatters,disclosurematters,potentialviolationsofsecuritiesorregulatorylaws,orfraudagainst stockholders, has the right to submitaconfidential,anonymouscomplaintdirectlytotheGroupGeneralCounsel/GroupComplianceOfficerofIdorsia.ThecomplaintshouldbemadeinwrittenformorthroughsuchothermethodsasaremadeavailablebytheCompanyforsuchpurposes,suchastheGlobalComplianceHelplineandprovidesufficientinformationsothatareasonableinvestigationcanbeconducted.
Proceduresforsubmittingconfidential,anonymouscomplaintsregardingaccounting,regulatory,&auditingmatters
Who should be contacted to report a compliance concern?Dependingonthenatureoftheconcern,there are several options for reporting a concern,includinglinemanagement,thelocalcompliancechampion,theCorporateComplianceOffice,andtheComplianceHelpline.
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
> Reporting, investigation, & enforcement
TheGroupGeneralCounseland/orGroupComplianceOfficershalldetermine,ordesignate appropriate persons to determine, appropriateactionstobetakenintheeventofviolationsofourCode.IntheeventofaviolationoftheCodebyamemberoftheBoardofDirectorsoranExecutiveOfficeroftheCompany,however,theBoardofDirectors shall determine the actions to betaken.SuchdisciplinaryactionsshallbereasonablydesignedtodeterwrongdoingandtopromoteaccountabilityforadherencetotheCode.
ShouldtherebeafindingthataDirector,officer,oremployeehasviolatedthisCode,theCompanywillprovidethemwithawritten notice of its determination, as well asthenatureofthedisciplinaryactiontobetaken(e.g.,censurebytheBoard,demotionorre-assignmentoftheindividualinvolved,suspensionwithorwithoutpayorbenefits,orterminationoftheindividual’semployment).
Violationsoftheidorsiacodeofbusinessconduct
In determining what action is appropriate inaparticularcase,theGroupGeneralCounsel,GroupComplianceOfficer,orBoardofDirectorsshalltakeintoaccountallrelevantinformation,includingthenatureand severity of the violation, whether theviolationwasasingleoccurrenceorrepeatedoccurrences,whethertheviolationappearstohavebeenintentionalorinadvertent,whethertheindividualinquestionhadbeenadvisedpriortotheviolationastothepropercourseofaction,andwhetherornottheindividualinquestionhadcommittedotherviolationsinthepast.
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
> Reporting, investigation, & enforcement
TheCorporateComplianceOfficecoordinatesthebusinessconductandcomplianceprograms,andisaresourcetoassistemployeeswithanswerstoquestionsorinterpretationsoftheIdorsiaCodeofBusinessConductandrelatedissues.Itisalsoaresourceforsupervisorsinmanagingcomplianceissues.TheGroupComplianceOfficer(GCO)isthechairmanoftheCorporateComplianceOfficeandreportsdirectlytoIdorsia’sNominatingandGovernanceCommittee.MembersoftheComplianceOfficeinclude:
Ifanemployeeisuncertainwhomtocontact,anyoftheindividualslistedabovemaybecontactedforassistance.Employeesshouldcontacttheseindividualstoaskquestions,raiseissuesorconcerns,orreportsuspectedviolations;anonymously,ifnecessary.Allegedcomplianceviolationswillbeinvestigated.Allemployeesarerequiredtocooperateinanyinvestigation.Failuretofullycooperatemayresultindisciplinaryaction,uptoandincludingtermination.
CorporatepoliciesreferredtointhispolicyandothergenerallyapplicablepolicieswillbepostedonQuatro,accessibleviatheIdorsiaintranet,orcanbeobtainedbycallingtheCorporateComplianceOffice.
The corporate compliance office
Idorsiarecognizesthehardworkandconstant attention needed to maintain high ethical standards and compliance prioritiesintheworkplace.IndividualemployeecommitmenttothisCodeofBusinessConductwilldemonstrateIdorsia’sdedication to integrity, professionalism, quality,respect,andhonesty.ShouldyouhaveanyquestionsorrequirefurtherclarificationrelativetoanyoftheSectionscontainedwithinourCode,pleasedonothesitatetoseekassistancefromyoursupervisor/manager,yourHumanResourcescontact,theGroupGeneralCounsel,ortheGroupComplianceOfficerofIdorsia.
Name Responsibility Phone E-mail
OliverPeinelt Legal&Compliance +41615581242 oliver.peinelt@Idorsia.com
OlivierLambert QA/CGMP/GCP/GLP +41615656751 olivier.lambert@Idorsia.com
AlexKhatuntsev HumanResources +41615656245 alex.khatuntsev@Idorsia.com
The Code
Legal compliance & ethical practices
The workplace
Data & information policies
Clinical&scientific integrity
Animal welfare
Personal responsibility
> Reporting, investigation, & enforcement
Idorsiaisanindependentbiopharmaceuticalcompanybasedonscienceandinnovation.Thecompanyisspe-cializedinthediscoveryanddevelopmentofsmallmol-ecules,totransformthehorizonoftherapeuticoptions.ItisheadquarteredinAllschwil/Basel,SwitzerlandandisquotedontheSIXSwissExchange(tickersymbol:IDIA).Alltrademarksarelegallyprotectedbytheirrespectiveowners.
DisclaimerThisfactsheethasthesolepurposetoprovidemembersofthepublicwithgeneralinforma-tionabouttheactivitiesofIdorsia.Theforward-lookingstatementsinthisfactsheetarebasedoncurrentex-pectationsandbeliefofcompanymanagement,whicharesubjecttonumerousrisksanduncertainties.
Idorsia Pharmaceuticals LtdHegenheimermatweg91CH-4123AllschwilSwitzerlandwww.idorsia.com
Financial Performance
Latestupdate: June2017
Copyright©2017Idorsia
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