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Addendum to Serono Holdings CIA

Addendum to Serono Holdings CIA

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Published by DLDLegal
Addendum to EMD Serono Holdings, Inc. CIA
Addendum to EMD Serono Holdings, Inc. CIA

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Categories:Types, Business/Law
Published by: DLDLegal on Jul 12, 2011
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07/12/2011

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1
ADDENDUMTOCORPORATEINTEGRITYAGREEMENT
BETWEENTHEOFFICEOFINSPECTORGENERALOF
THE
DEPARTMENTOFHEALTHANDHUMANSERVICES
AND
EMD
SERONOHOLDING,
INc.
I.
PREAMBLE
EffectiveOctober14,2005,SeronoHolding,Inc.enteredintoaCorporateIntegrityAgreement(CIA)withtheOfficeofInspectorGeneral(OIG)oftheUnitedStatesDepartmentofHealthandHumanServices(HHS).In2007,thefollowingentitiescoveredbytheCIAchangedtheirnames
as
follows:
(1)
SeronoHolding,Inc.changeditsnameto
EMD
SeronoHolding,Inc.;and
(2)
Serono,Inc.changeditsnametoEMDSerono,Inc.TheCIAappliesto
EMD
SeronoHolding,Inc.,and
all
ofitsU.S.biopharmaceuticaloperatingsubsidiariesandaffiliatesthataresubjecttothestatutes,regulations,andwrittendirectivesofMedicare,Medicaid,and
all
otherFederalhealthcareprograms(asdefined
in
42U.S.C.
§
1320a-7b(f))(Federalhealthcareprogramrequirements)andthestatutes,regulationsandwrittendirectivesoftheFoodandDrugAdministration(FDArequirements).
EMD
SeronoHolding,Inc.
(EMD
SeronoHolding)herebyentersintothisAddendumtotheCIA(Addendum).ThisAddendumappliesto
EMD
Serono
Holding
andallofitssubsidiariesandaffiliates,includingbutnotlimited.to
EMD
Serono,Inc.,EMDSeronoResearchInstitute,Inc.,EMDSeronoResearchCenter,Inc.,and
EMD
SeronoBiotechCenter,Inc(collectively"EMDSerono").ForpurposesofthisAddendum,"affiliate"shallmeananyentitythatisownedorcontrolled,directlyorindirectly,byEMDSeronoHolding,·Inc.,andwhoseemployeesorcontractorsperform''PromotionalFunctions"and"ProductRelatedFunctions,"
as
definedbelowinSectionsn.C.4andS.SeronoLaboratories,Inc.,EMDSerono,Inc.,AresTradingS.A.,andMerckSeronoS.A.(formerlymown
as
SeronoS.A.)
will
beenteringintoaSettlementAgreementwiththeUnitedStates(SettlementAgreement).SeronoLaboratories,Inc.,EMDSerono,Inc.,
Ares
TradingS.A.,andMerckSeronoS.A.arehereafterreferredtoasthe"SerenoSettlementAgreementParties."TheSeronoSettlementAgreementParties
EMDSeronoHolding,
Inc.-
AddendumtoCorporate
Integrity
Agreement
 
2
'also
will
enter
into
settlementagreements
with
variousStates;and
HMD
SerenoHolding'sagreementtothisAddendumisaconditionprecedenttothoseagreements.
n.
TERM
ANDSCOPEOFTHE
CIA
AND
ADDENDUM
A.
ContinuationofCIAandTennofAddendum.AlloftheobligationssetforthintheCIAshallcontinuefortheperiodsetforthintheCIA,andENIDSeronoshallcomplywiththeCIAobligationsfortheremainderofthetermoftheCIA.Inaddition,unlessotherwisespecificallyrevisedbythisAddendumorexcepted,alloftheprovisionsoftheCIAshallbeandherebyareincorporatedintothisAddendum.andshallremain
in
fullforceandeffectduringtheperiodcoveredby
this
Addendum.EMDSeronoshallcomplywith
all
obligationsoftheCIA
that
areincorporatedintothisAddendum,allCIAobligations
that
aremodified
in
this.
Addendum,andallnewobligationssetforth
in
thisAddendum.Whereatermisdefineddifferently
in
thisAddendum
than
in
theCIA,asoftheEffectiveDateoftheAddendum,EMDSeronoshallcomplywiththetermasdefined
in
thisAddendum.ThetermofcomplianceobligationsassumedbyEMDSeronoundertheAddendumshallbethreeyearsfromtheEffectiveDateoftheAddendum,unlessotherwisespecified.TheEffectiveDateofthisAddendumshallbetheEffectiveDateoftheSettlementAgreement,Eachone-yearperiod,beginningwiththeone-yearperiodfollowingtheEffectiveDateof
this
Addendum,shallbereferredtoasa"ReportingPeriod."B.SectionU.B.oftheCIA.SectionII.BoftheCIAremains
in
effectthroughthetermoftheCIAandthisAddendum.EMDSerono'sfinalAnnualReportshallmeanthefinalAnnualReportdueunderthisAddendum.
EMDSeronoHolding,Inc.-Addendum
to
CorporateIntegrityAgreement
 
3
C.Definitions.ThedefinitionssetforthatSectionII.CoftheCIAshallapplyunmodifiedtotheCIAthroughendofitsterm.AsoftheEffectiveDateofthisAddendum,thedefinitionssetforthatSectionII.CoftheCIAshallbereplacedwiththefollowingdefinitions,whichshallapplythroughoutthetermofthisAddendum:1."CoveredPersons"includes:a.
all
ownerswhoarenaturalpersons(otherthanshareholderswho:(1)haveanownershipinterestoflessthan5%and(2)acquiredtheownershipinterestthroughpublictrading),officers,directors,andemployeesofEMDSeronoHolding,Inc.anditssubsidiariesandaffiliates,includingbutnotlimitedtoEMDSerono,Inc.,EMDSeronoResearchInstitute,Inc.,EMDSeronoResearchCenter,Inc.,andEMDSeronoBiotechCenter,Inc;andb.allcontractors,subcontractors,agents,andotherpersonswhoperformPromotionalFunctionsorProductRelatedFunctionsonbehalfofEMDSerono;Notwithstandingtheabove,theterm"CoveredPersons"doesnotinclude:part-timeorperdiememployees,contractors,subcontractors,agents,andotherpersonswhoarenotreasonablyexpectedtoworkmorethan160hoursperyear,exceptthatanysuchindividualsshallbecome"CoveredPersons"atthepointwhentheyworkmore
than
160hoursduringthecalendaryear.2."RelevantCoveredPersons"includes
all
CoveredPersonswhosejobresponsibilitiesrelatetoPromotionalFunctionsorProductRelatedFunctions.3."GovernmentReimbursedProducts"referstoallEMDSeronohumanpharmaceuticalproductspromotedorsoldbyEMDSerono
in
theUnitedStates
that
arereimbursed
by
FederalhealthcareprogramsorpursuanttocontractswiththeUnitedStates.
EMDSeronoHolding,Inc.-AddendumtoCorporateIntegrityAgreement

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