/ors/ q{ f # fc_ o,f

CLINICAL STUDY AGREEMENT

betweenICON Clinical Research Limited

andLiptovskd nemocnica s poliklinikou

MUDr.Ivana Stodolu Liptovskf Mikul65

Pfizer Protocol # 81481038

This Clinical Study Agreement("Agreement") between

ICON Clinical Research Limited with aplace of business at South County BusinessPark, Dublin 18, Ireland VAT ID: IE8201978R Represented by Pharm.Dr. PavelLebesle, MBA, based on Power of Attorney("cRo")

and

Liptovsk6 nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikul65,with a place of business at Pahidanskf25,Liptovskf Mikuld5 03123, Slovak Republic("Institution"),

when signed by all parties, is effective as of

Pfizer Inc. ("Pfizer") wishes to sponsor aclinical study entitled "PHASE 3 MULTICENTER, DOUBLE BLIND,RANDOMVED. PLACEBOCONTROLLED. PARALLEL GROUPEVALUATION OF THE EFFICACY,SAFETY. AND TOLERABILITY OFBOCOCTZUMAB (PF -04950615), INREDUCING THE OCCURRENCE OFMAJOR CARDIOVASCULAR EVENTSIN HIGH RISK SUBJECTS" ("Study") tobe conducted by Peter Kydina, MD, PhD("Principal Investi at Institution

ZM.LUYA O VYKONAVKLINICKEI STUOIB

medziICON Ctinical Research Limited

a

Liptovsk6 nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikul65

Protokol spoloinosti Pfizer i. 814E1038

T6to zmluva o vykondvan( klinickej Stfdie(d'alej len ako,,zmluva") medzi

spolodnost'ou ICON Clinical ResearchLimited, so sfdlom na adrese South CountyBusiness Park, Dublin 18, irsko VAT ID: IE820 1 97 8R zastipenf Pharm.Dr. PavlemLebesle, MBA nazdklade plnej moci(d'alejlen ako,,zmluv nd vyskumn6 or ganiz6cia")

a

Liptovsk6 nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikul65,so sidlom na adrese Palddanskd 25.Liptovsky Mikul{S 031 23, Slovenskdrepublika (d alej len ako ,,in5titricia"),

nadobrida podpisom vSetkfch zmluvnychstrdn platnost' dia2i. s" ?-1r,f

Spolodnost' Pfrzer Inc. (d alej len ako

,,spolodnos( Pfrzer") si Lelfbyfzadfvatelom klinickej Stridie s n6zvom,,MULTICENTRICKE, DVOJITOZASLEPENE, RANDOMIZOVANE,PLACEBOM KONTROLOVANESKUSANIE FAZY 3 S PARALELNfMISKUPINAMI HODNOTIACE UdINT.IOST.BEZPEdNOST A ZNASANLIVOSfPRIPRAVKU BOCOCZUMAB (PF -04950615) NA ZNIZENIE VYSKYTUzAvtzvtcrtKARDIOVAS KULARNYCH UDALOSTI

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\

A Symbol of Excellenceunder the Pfizer protocol identified above("Protocol"). Pfizer has delegatedresponsibility for management of this Study,including contracting and Study monitoring,to CRO, and has authorized CRO to bindPfizer to all commitments within thisAgreement identified as belonging to Pfizer.There is a separate agreement between CROand the Principal Investigator relating to theStudy (see Section 1.3 below).

The parties agree as follows:

l. Responsibilities

1 .1 Investigators and ResearchStaff. The Study will be conducted byPrincipal Investigator at Institution.Institution will ensure that individuals whoassist in the conduct ofthe Study as sub-investigators or research staff who areemployees or contractors of Institution areappropriately trained and qualified.

1.2 Compliance Obligations.Institution is responsible to CRO andPfizerfor compliance by all Study personnel whoare Institution employees or contractors withthe terms of this Agreement andInternational Conference on HarmonizationGood Clinical Practice (ICH GCP)guidelines, as well as applicable law,regulations, and governmental guidance.

between CRO r.3

U VYSOKORIZIKOVYCH PACIENTOV"(d alej len ako ,,Stfdia"), ktorf mdvykondvat'MUDr. Peter Kydina, PhD(d alej len ako ,"hlavny skri5ajrici")v in5titfcii nazSkTade vySSie uvedendhoprotokolu spolodnosti Pfizer (d alej len ako,,protokol"). Spolodnos t' Pfrzer poverilazodpovednost'ou za vedenie tejto Sttidievrdtane uzatv 6r ania zmlfiv a sledovaniaStf die zmluvnf vf skumnri or ganiz6ciua splnomocnila ju plnit' ztvazky zaspolodnost' Pfrzer podl'a tejto zmluvy, ktor6sri urdend ako z6ryazky spolodnostiPfizer.Medzi zmluvnou vyskumnou or ganiz6cioua hlavnym skriSajricim existuje samostatn6zmluva tlkajtca sa Stridie (pozri dast'1.3niZSie).

Zmlavnd strany srihlasia s tfmitopodmienkami:

1. Povinnosti

1.1 Skri5ajrici a vYskumnlrpersoniil. Stddiu bude vykon6vat' hlavnyskf 5 aj dci v in Stitricii. In Stitri ci a zab ezpedlZe osoby, ktord budri pomdhat'privykondvanf Stfdie ako pomocnf skri5ajricialebo vyskumny persondl a ktord srizamestnancami a dod6vatel'mi in5titricie,budri pr(sluSne vy5kolen6 a kvalifikovan6 natento fdel.

I.2 DodrZiavanie povinnostf.In5titricia zodpoved6 zmluvnej vyskumnejorganizdcii a spolodnostiWizer zato, Lev5etci pracovnici Stridie, ktori srizamestnancami alebo doddvatefmiin5titricie, budri dodrZiavat' podmienky tejtozmluvy, smernice Spr6vnej klinickej praxeMedzin6rodnej konferencie o harmonizdcli(ICH GCP), platn6 prdvne predpisy,nariadenia a Stdtne pokyny.

medzi zmluv1.3

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Page 2 of 66

nym

skri5ajricim a srivisiace povinnosti hlavn6ho

skri5ajriceho vodi zmluvnej vyskumnej

organizdcii a spolodnosti Pfizer budti

zdokumentovand v samostatnej zmluve

medzi zmluvnou vli skumnou or ganizdciou

a hlavnjm skri5ajricim' InStitriciapotvrdzuje, Levie o tejto samostatnej

zmluve. In5titricia d'alej potvr dzuje, Le

dostala rovnopis tejto zmluvy (bud

s rozpodtom Stridie vo forme dodatku alebo

bez neho) alebo inak uspokojivo dostala

inform6cie tikajrice sa pr6va a povinnosti

hlavn6ho skri5ajriceho v srivislosti so

Stridiou.

In5titricia a hlavny skuSajfci stanovi

rozdelenie povinnosti medzi inStitriciu

a hlavndho skri5ajriceho na vykon6vanie

dinnost( v sfvislosti so Stfdiou podl'a

poZiadaviek protokolu alebo ridajov v tejto

zmluve alebo zmluvy medzi zmluvnou

sri

priraden6 hlavnym skri5ajricim prfslu5nymi

nariadeniami upravujricimi vykon6vanie

klinickfch vyskumov. In5titricia poskytne

primerani dohllad nad dinnost'ami hlavn6ho

skriSajriceho v in5titricii' In5titricia d alej

srihlasi so spolupr6cou so zmluvnou

vf skumnou or ganizilciou alebo

spolodnost'ou Pfizer, ak to bude potrebnd,

aby pomohla vyrieSit' ak6kol'vek otdzky

tjkajrice sa dodrZiavania povinnostf

hlavnym skri5ajricim v r6mci jeho

povinnosti srivisiacich so Stridiou.

1.5 Skolenie o sPrdvnej klinickejpraxi. Hlavnf sku5ajrici a v5etci pomocnf

skri5aj rici pred zaradenim akf chkotveksubjektov do Stridie (podl'a dasti 4 -

and Principal Investieator. Study conduct

by Principal Investigator and Principal

Investigator's associated obligations to CRO

and Pfizer are documented in a separate

agreement between CRO and PrincipalInvestigator. Institution confirms that it isaware of this seParate agreement'

Institution further confirms that it has

received a copy of that agreement (either

with or without inclusion of the Study

Budget attachment) or has been otherwise

satisfactorily informed as to Principal

Investigator' s Study-related rights and

responsibilities.

Division of Responsibilities.

enrollment of any Study Subjects (as

defined in Section 4, Subject Enrollment),

Principal Investigator and any sub-

will complete a CRO-Provided

Institution and Principal Investigator willdetermine the division of responsibilities

between Institution and PrincipalInvestigator for Study-related activities

required by the Protocol or identified in this

Agreement or the agreement between CRO

and Principal Investigator. However,

Principal Investigator will, at minimum,assume all those responsibilities assigned to

principal investigators by the relevant

iegulations governing the conduct of clinical

investigations. Institution will provide

appropriate oversight of Principal

Investigator activities within the Institution'

Institution further agrees to cooperate withCRO or Pftzer if needed to help resolve any

issues relating to compliance by Principal

Investigator with his/her Study-related

responsibilities.

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--

izer':I-pori

one i

:tit l

PRIPi,:fi:-,it :-,:a;;.

En

cS,\ -:iet;ml€r -

l_,_l.r_ Lil

A Svrnbol of Excellence

SWP_CSA 3(a)_Institution_Slovakia01 September 2013B 1481038_ Liptovskil nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovsky Mikulil5_site 2172_Kycina

Good Clinical Practice training course("CRO GCP Training"). Any investigatorswho later join the Study will complete theCRO GCP Training before performingStudy-related duties. For studies ofapplicable duration, Principal Investigatorand sub-investigators will complete CROGCP Training every three years during theterm of the Study, or more often if there aresignificant changes to the ICH GCPguidelines or course materials.

2. Funding. CRO will provide fundingto Institution as compensation forInstitution's services and the use ofInstitution's facilities for the Study as

delineated in Attachment A, Study Budgetand Payment Terms, and subject to theterms specified in that Attachment. CROwill provide funding to the PrincipalInvestigator as compensation for PrincipalInvestigator's Study conduct activities underthe agreement between Pfizer and PrincipalInvestigator.

2.I Investigator Meetings. Ifany Study personnel who are Institutionemployees or contractors are required toattend investigator meetings for this Study,CRO will anange and pay directly for traveland accommodation and will cover thereasonable costs of meals in connection withthose meetings, but does not providecompensation for such attendance.

o spr6vnej klinickej praxi, ktory zabezpedizmluvn6 vliskumn6 organizdcia (d alej lenako ,,Skolenie o sprdvnej klinickej praxizmluvnej vyskumnej or ganiz6cie"). V5etciski5ajrici, ktorf sa zapoja do Stridie nesk6r,pred vykon6van(m povinnosti srivisiacich so

Sfiidiou absolvujri Skolenie o spr6vnejklinickej praxi zmluvnej vyskumnejorganizdcie. V pripade Stridiizodpovedajfcej dlZky trvania absolvujetakdto Skolenie o sprdvnej klinickej praxizmluvnej vyskumnej or ganizdcie hlavnfskf5ajfci a v5etci pomocnf skf5ajfci kai.d6,

tri roky podas trvania Stridie, prfpadnedastejSie, ak d6jde kv'!razn'!m zmen{mv pokynoch smernfc Sprdvnej klinickejpraxe konferencie ICH alebo v materidlochkurzu.

2. Financovanie.Zmlwnfvyskumn6or ganizilcia poskytne in5titricii finandndprostriedky ako n6hradt za jej sluZbya pouZitie jej zariadeni na fdely Stfdiepodl'a dodatku A - Rozpodet Stridiea platobnd podmienky, anazdkladepodmienok uvedenych v tomto dodatku.Zmluv nd vy skumn6 or ganizdcia po skytnehlavndmu skriSajricemu fi nandn6 prostriedkyako n6hradu za vykon6vanie dinnostisrivisiacich so Stfdiou nazdkJade zmluvymedzi spolodnost'ou Pfizer a hlavnymskfSajfcim.

2.1 Stretnutia skri5ajricich. Ak jepotrebnd, aby sapersondl Stfdie tvorenyzamestnancami alebo doddvatel'mi in5titriciezridastnil stretnuti skf5ajfcich na ridely tejtoStrjdie, zmluvn6 vf skumnd or ganiz1ciazabezpedi a priamo zaplati za cestovaniea ubytovanie a uhradf primeran6 nSklady nastravu v srivislosti s tjmito stretnutiami,av5ak neposkytne platbu zatak:iuto fdast'.

Page 4 of 66

22 Disclosure bv Pfizer. In the interest of Z: lost<ytnutie inform6cif spolodnost'ou

transparency relating to its financialrelationships with cliriical investigators and

clinical study sites, Pfizer may publiclydisclose the funding associated with this

Agreement. Any such report by Pfizer willclearly differentiate between payments

made to institutions and payments made to

individuals.

3. Protocol. Principal Investigator and

Institution will conduct the Study and

Study-related activities in accordance with

the Protocol, including, but not limited to,

the requirements relating to State Institute

for Drug ControU or lndependent Ethics

Committee fSUru-mC) aPProval and

adverse event rePorting.

3.1 Amendments. The Protocol

may be modified only bY a writtenamendment, approved bY Pfizer, the

Principal Investigator, and the responsible

SdrrnBC ("Amendmenf') excePt, as

described in the Protocol, for emergency

changes necessary to protect the safety ofthe Study Subjects (as defined in Section 4,

Subject Enrollment).

Pfrzer . Y z6ujme transp arentno sti sriv i si acej

s finandnym vzt'ahom s klinickimiskriSajricimi a klinickfmi pracoviskami

Sttidie m6Ze spolodnost' Pfizet zverejnitfinancovanie spojen6 s touto zmluvou.

Vo v5etkych sprdvach spolodnosti Pfrzer

tohto druhu budri jasne tozdelend platby

in5tifiicii a platby jednotlivcom.

3. Protokol. HlavnY skri5ajfci a

in5titricia bude vykon6vat' Sttidiu a dinnosti

srivisiace so Sfiidiou v srilade s protokolom,

najmi s poZiadavkami Stdtneho fstavu pre

kontrolu liediv alebo nezdvislej etickej

komisie (d'alej len ako ,,SUKL" alebo

,,nezdvisl6etick6 komisia") na schv6lenie

a hl6senie neZiaducich udalosti:

3.1 Dodatky. Protokol moZno

zmenit iba pfsomnym dodatkompodpfsanym spolodnost'ou Pftzer, hlavnliminiSairicim a iodpovednym SUrL alebo

nez6vislou etickou komisiou (d'alej len ako

,,dodatok"), oktem zmien v naliehavychpripadoch nevyhnutnych na zaistenie

ochrany a bezpednosti subjektov zaradenich

do Sfiidie (podlia dasti 4 -Zatadeniesubjektov) v srilade s protokolom.

3.2 No Additional Research. No 3.2 Z6kaz d'al5ieho vVskumu. Na

additional research may be conducted on

Study Subjects (as defined in Section 4,

Subject Enrollment) during the conduct ofthe Study or on biological samples collected

during the conduct of the Study unless it isapproved by CRO and documented as an

Amendment to the Protocol or made subject

to mutually agreeable terms otherwise

documented by the Parties.

subjektoch Stridie (podl'a dasti 4 -Zaradeniesubjektov) alebo biologickfch vzork6ch

ziskanych podas vykondvania Stridie nie je

moLn€ podas vykon6vania Stridie vykon6vat'

Liaden d'alSf vf skum, ktory neschv6lila

zmluvn6 viskumnd organizdcia a ktot' nieje zdokumentovanf formou dodatku kprotokolu alebo nie je predmetom vz6jomne

odsrihlasenych podmienok inakzdokumentovanich zmluvnymi stranami'

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A Svmbol of Excellence

4. Subject Enrollment. PrincipalInvestigator and Institution have agreed toenroll qualified Study participants duringthe CRO-specified enrollment period, unlessCRO modifies the enrollment period bywritten notice. A qualified participant isone who meets all Protocol criteria forinclusion in the Study ("Study Subject,,).

4.I Multi-Center Studies. CRO may endStudy Subject enrollment early if the totalenrollment needed for a multi-center studyhas been achieved before the end of theenrollment period for this Study.

5. Studli Conduct

5.1

Institution will not charge a Study Subjector third-party payer for Investigational Drug(see Section 8, Investigational Drug) or forany services reimbursed by CRO under thisAgreement or the agreement between CROand Principal Investigator.

Breaches. Institution will inform CROimmediately of (a) any urgent safetymeasures taken by Principal Investigator toprotect Study Subjects against immediatehazard and (b) any serious breaches of theProtocol or of ICH GCP guidelines of whichInstitution becomes aware.

4. Zarad'ovanie subjektov. Hlavnyskf5ajfci a in5titricia srihlasil, Le zarudiridastnikov Stridie spifa;ricich podmienkypodas obdobia zaratovania, ktor6 stanovizmluv n6 vf skumn6 or ganizdcia, pokial'zmluv nd vf skumni4 or ganizilcie nezmeni

d'ovania p(somnym oznamom.ktory splfia podmienky, jektoril splfia v5etky krit6ri6

protokolu pre zaradenie do Stridie (dalej lenako,,subjekt Stridie").

4.L Stfdie vykon6van6 na viacerVchpracovisk6ch . Zmluv nd vySkumn6or ganiz1cia m6Ze ukondit' zarad'ovaniesubjektov Stridie preddasne, ak sa dosiahnecelkovy podet zapfsanlch subjektov Stridiena v iacer! ch pracoviskr4ch pred skondenimobdobia zdpisu do Stridie.

In5titricia nebude subjektom Stridie aniindmu platcovi - tretej osobe - ridtovat'poplatok za skri5any liek (pozri 8. dast'-Sku5any liek) ani zaLiadne sluZbyuhr ildzand zmluvnou vf skumnouorganizilciou podl'a tejto zmluvy alebozmluvy medzi zmluvnou vfskumnouor ganizdciou a hlavnym skri5ajricim.

. In5titriciabude bezodkladne informovat' zmluvnrivfskumnri organizdcia (a) o v5etkychnaliehavych bezpednostnych opatreniach,ktor6 prijme hlavnj skri5ajfci na ochranusubjektov Stfdie proti okam1itdmunebezpedenstvu, a (b) o v5etky ch z6vaLnlch

iach protokolu alebo smernic

5. Vykoni4vanie Stridie

Chargins Studl/ Subjects. I S.t Poplatky od subjektov Stridie.

5.2 Safety Measures and Serious I S.Z Bezpednostn6 opatrenia

of Excellence

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6. Data Protection and FDA FinancialDisclosure

6.I Personal Data. Personal datais any information from which it is possibleto identify an individual. Personal data thatconcerns health information is sensitivepersonal data. Personal data collected inassociation with the Study will includepersonal data relating to the PrincipalInvesti gator, sub-investigators, researchstaff, third parties, and possibly StudySubjects (which could include sensitivepersonal data) (collectively "PersonalData"). Such Personal Data may be subjectto specific legislation relating to itsprocessing, storage, transfer anduse. Institution will comply with allrelevant laws relating to the protection anduse of Personal Data and data privacy in itsStudy-related activities. Institution will takeall appropriate technical and organizationalmeasures to prevent damage to, ordisclosure, unauthorized or unlawfulprocessing, or accidental loss or destructionof such Personal Data. CRO and Pfizer willtake appropriate measures to protect theconfidentiality and security of all PersonalData that they receive in connection with theStudv.

6.2 Use bv CRO andPfizer. Personal Data will be processed andused for the purposes of administration ofthis Agreement and in connection with theStudy. Information relating to the PrincipalInvestigator, sub-investigators, and researchstaff will be held on one or more databases

Spr6vnej klinickej praxe Medzin6rodnejkonferencie o harmonizdcii. o ktorVch sa

in5titricia dozvie.

6. Ochrana ridajov a poskytnutiefinandnych ridajov riradu FDA

6.1 Osobnd ridaje. Osobnd ridajesri v5etky inform6cie, zktorlch je moZne

urdit' totoZnost' jednotlivca. Osobnd fdaje,ktord sa tlkajn zdravotndho stavu, sri

citlivymi osobnymi fdajmi. Medzi osobn6ridaje ziskan6 v srivislosti so Stridiou budfpatrit'osobn6 fdaje tykajrice sa hlavn6hoskriSajriceho, pomocnych skri5ajricich,vyskumndho persondlu, tretfch str6na pripadne aj subjektov Sttidie (ktor6 mOZu

zahfiaf citliv6 osobn6 ridaje) (d alej lenspolodnym n1zvom ako ,,osobn6 ridaje").Tak6to osobnd ridaje mOZu byt'predmetomosobitnych z4konny ch predpisov tfkajfcichsa ich spracovania, uchovdvania, prenosua pouZitia. In5titricia bude pri dinnostiachtfkajricich sa Stridie dodrliavat v5etkyrelevantn6 pr6vne predpisy tykajrice sa

ochrany a pouLitia osobnych ridaj ova ochrany ridajov. In5titricia podniknev5etky primeran6 technick6 a organizaEndopatrenia, aby zabr 6nila po5kodeniu,zverejneniu, neopr6vnen6mu dinezdkonn6mu spracovaniu, pripadne strate

alebo znideniu takychto osobnfch fdajov.Zmluv nd vyskumn6 or ganizdciaa spolodnosf Pfizer podniknri prfsluSndopatrenia na ochranu d6vernostia bezpednosti v5etkych osobnych ridajovprijatych v srivislosti so Stridiou.

6.2 PouZitie ridaiov zmluvnouvfskumnou organiz6ciou a spolodnost'ouPfizer. Osobn6 fdaje budf spracovandapoulitd na ridely plnenia povinnost(vyplyvajfcich z tejto zmluvy a v srivislostiso Stridiou. Inform6cie tykajfce sa hlavn6ho

jfceho, pomocnfch sku5aifci

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I

for the purpose of determining theirinvolvement in future research and in orderto comply with any regulatory requirements.

6.3 Financial Disclosure. Where theStudy is deemed by Pfizer to be a "coveredstudy" for the purpose of the United StatesFood and Drug Administration regulationentitled "Financial Disclosure by ClinicalInve stigators" (the "FDA Regulation"),Institution will ensure that any sub-investigator engaged in the Study who is anInstitution employee or contractor agrees todisclose to CRO all relevant financial andother information (including details ofequity interests in Pfizer or any of itsaffiliates) relating to the sub-investi gators(and, where relevant, spouse and dependantsof sub-investigator) as required by CRO toenable Pfizer to comply with the FDARegulation.

6.4 Disclosure and Transfer. Some ofthe Personal Data discussed in this Section 6may be disclosed or transferred to othermembers of the CRO or Pfizer group ofcompanies, to representatives andcontractors working on behalf of the CROor Pfizer group, and to regulatory authoritiesacross the world. The Institution will ensurethat all necessary consents are in place tocomply with the provisions of this Section 6with respect to any affected employees orcontractors of Institution.

a vyskumnlich pracovnftov budri uchovan6v jednej alebo viacerych datab6zach nafdely urdeniaich zapojenia do budricehovliskumu a s ciel'om plnit' pripadndpoZiadavky reguladnfch riradov.

6.3 Poskytnutie finandnlfch ridajov. Akspolodnost' Pfrzer usridi, Ze Stridia j e,,krytouStfdiou" na ridely nariadenia s ndzvom,,P o slqttnutie finaninj ch fidaj ov klinicbjmiskrtiajficimi" Americkdho fradu prekontrolu potravin a liediv (FDA) (d'alej lenako ,,nariadenie riradu FDA"), in5titriciazaistf srihlas v5etkfch pomocnychshi5aj f cich zamestnan'fch in5titriciou azapojen'fch do Stridie s poskytnutimv5etkjch relevantnych finandnych a dalsichinformdcii (vr6tane podrobnych informdcifo vlastnfckych podieloch v spolodnostiPfrzer alebo jej pobodkdch) zmluvnejvyskumnej or ganizdcii tykajricich sapomocn6ho skf5ajriceho (pripadne ajzdkonn! ch partnerov di vyZivovany'chrodinnych prfslu5nftov pomocn6hoskf5ajfceho), ak to bude poZadovat'zmlav nd vyskumn6 or ganizlcia, abyumoZnilo spolodnosti Pfizer konat' v srilades nariadenim riradu FDA.

6.4 Poskvtnutie a prenos ridajov.Niektor6 osobn6 ridaje uveden6 v 6. dastimoZno poskytnrit' alebo odov zda( inlmdlenom zmluvnej vyskumnej or ganizdciea skupiny firiem spolodnosti Pfrzer,z6stupcom a dod6vatel'om pracuj f cimv mene zmluvnej vfskumnej organiz6ciea skupiny firiem spolodnosti Pfrzera reguladnlim fradom na celom svete.In5titricia zaisti, aby boli k dispozicii v5etkypotrebnd srihlasy na dodrZiavanieustanoveni tejto 6. dasti v srivislosti s

kaLd! m dotknutym zamestnancoma dod6vatel'om in5titricie.

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of Excellence

a. Ozndmeniavvplyvajrice z dohody Safe Harbor. Ak sa

jednotlivci srivisiaci so Stfdiou, ktorychosobnd ridaje m6Zu byt'poskytnut6zmluvnej vyskumnej or ganizdclia spolodnosti Pfizer, nach6dzajiv Eur6pskej fnii alebo vo Svajdiarsku,in5titricia bude informovat' v5etkjchdotknutf ch zamestnancov alebodod6vatel'ov in5titricie a inri prislu5nri tretiustranu o zaradeni zmluvnej vyskumnejorganizdcie a spolodnosti Pfizer doprogramu bezpedn6ho pr(stavu (SafeHarbor) meidzi EU a USA. In5titdciaposkytne tymto dotknutjm jednotlivcomformuli4r ozndmenia, ktord bude dostupndv zmluvnej vyskumnej organizilciia v ktorom bude uveden6, akym spdsobomzmluv nd vy skumnd or ganiz6ciaa spolodnost Pfrzer zamylla}iu pouZit'osobnd ridaje a in6 pr(sluSnd informdcie.

7. Informovany srihlas a n6borsubiektov.

In5titricia poskytne sridinnost' hlavn6muskri5ajricemu na zabezpedenie ziskaniapf somnych informovanych srihlasovv pripade kaZddho subjektu Stridie. Indtitriciaposkytne sf dinnost' hlavndmu skri5ajricemuna to, aby mala zmluvn6 vyskumn6organizilcia moZnost' prehodnotit' a schv6lit'dokument informovandho sfhlasu (vr6tanerevizii vykonanych podas Stridie) pred jehopouZitim.

N6bor subjektov. In5titriciaposkytne sridinnost' hlavn6mu skri5ajricemuna to, aby zmluvn6 vyskumnd organizdciamohla skontrolovat' a schv6lit' obsahakychkol'vek materidlov pre n6bor doSfiidie, urdenjch potenci6lnym subjektom

a. Safe Harbor Notice.When the individuals associated with theStudy about whom Personal Data may be

disclosed to CRO and Pfizer are located inthe European Union or Switzerland,Institution will inform any affectedemployees or contractors of Institution and

any other appropriate third party of CRO'sand Pfizer's enrollment in the EU-US Safe

Harbor program. Institution will also

furnish such affected individuals a form ofnotice, to be made available by CRO, settingout the intended use of the Personal Data byCRO and Pftzer and other pertinentinformation.

7. Informed Consent and SubjectRecruitment.

Institution will cooperate with PrincipalInvestigator to ensure that a writteninformed consent is obtained for each StudySubject. Institution will also cooperatewith Principal Investigator to provide CROan opportunity to review and approve thecontent of the informed consent document(including any revisions made during thecourse ofthe Study) before it is used.

7.2 Subject Recruitment.Institution will cooperate with PrincipalInvestigator to provide CRO an opportunityto review and approve the content of anyStudy recruitment materials directed topotential Study Subjects before suchmaterials are used. This requirement a

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of Excellence

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to all such materials, regardless of medium.

8. Investigational Drug. CRO willzurange for Institution [PrincipalInvestigator] to receive, at no charge,

sufficient quantities of the Pfrzet product

that is being studied ("Pfizet Drug") to

conduct the Study. Unless otherwise

indicated in Attachment A (Study Budget

and Payment Terms), CRO will also arrange

for Institution [Principal Investigator] to

receive at no charge, or will cover the costs

of, any other Protocol-required drugs (e.g.'

placebo, comparator drug, concomitantdrug). Any other Protocol-required drug

that CRO provides or covers the cost of is,

together with the Pfizer Drug, considered

"Investigational Drug."

8.1 Custody and Dispensing.

Institution will, or will cooperate withPrincipal Investigator to, maintainappropriate control of supplies ofInvestigational Drug and will not administer

or dispense it to anyone who is not a Study

Subject, or provide access to it to anyone

except Study personnel.

8.2 Use. Institution will ensure'

or cooperate with Principal Investigator inensuring, that Investigational Drug is used

only as specified in the Protocol. Any other

use of Investigational Drug by an Institutionemployee or contractor constitutes a

material breach of this Agreement.

T6to poLiadavka sa vzt'ahuje na v5etkytakdto materii4ly bez ohl'adu na mddium.

8. Skri5an:f liek.Zmhxn|vYskumn6or ganizdcia zab ezpeli, aby [hlavnyskri5ajricil na ridely vykondvania Stridie

bezplatne dostala dostatodnd mnoZstvo lieku

spolodnosti Pfrzer, kton-i sa m6 skri5at'

(d alej len ako ,,liek spolodnosti Pfizer")'Pokiall nie je inak uveden6 v dodatku A(Rozpodet Stridie a platobnd podmienky),

zmluvnd vy skumn6 or ganiz6cia zab ezpeEi,

aby in5titricia [hlavny skri5ajrici] dostala

bezplatne aj in6lieky potrebn6 nazdkladeprotokolu, alebo uhradf ndklady na ne (napr.

placebo, porovniivac( liek, sfdasnepoddvany liek). Akykol'vek iny liekpoZadovany na zdklade protokolu, ktoryzmluvn6 vyskumnd ot ganizdcia poskytne

alebo uhradf n6klady nail, sa spolu s liekomspolodnosti Pftzer povaZuj e za,,skiSanyliek".

8.1 Uchovanie a vyd6vanie.

In5titricia poskytne sridinnost' hlavndmuskri5aj ricem u na zabezpedenie vhodnejkontroly z6sob skri5andho lieku a nebude ho

poddvat' ani vyd6vat' nikomu, kto nie je

subjektom Stridie, ani neumoZnf pr(stup

k lieku nikomu okrem skri5ajricehopersondlu.

PouZitie. In5titricia zabezPeli8.2

8.3 Ownership of Pfizer Drug'

alebo poskytne sf dinnost' hlavn6muskri5ajricemu pri zabezpedenf, aby sa

skri5any liek pouZival len v srilade

s protokolom. Akdkol'vek in6 pouZitie

skriSandho lieku zamestnancom alebo

dod6vatellom in5titricie predstavuje ztv aLn6

poru5enie tejto zmluvY'

8.3 Vlastnictvo lieku spolodnosti

Pfrzer Drus is and remains the property of . Liek spolodnosti Pfrzer ie a zostdva

Page 10 of 66

U. Study Data (as c.defined in Section 11, Study Data,Biological Samples, and Study Records),d. Biological Sample d.Analysis Data (as defined in Section 11.Study Data, Biological Samples, and StudyRecords, below),e. Attachment A (StudyBudget and Payment Terms) to thisAgreement, andf. any other informationrelated to the Study, the pfizer Drug, orCRO, Pfizer, or Pfizer affiliate technology,research, or business plans that CRO, pfizer,or aPfizer affiliate provides to PrincipalInvestigator or Institution in writing or othertangible form and marks asCONFIDENTIAL or initially disclosesorally and then summarizes and confirms inwriting as CONFIDENTIAL within 30 davsafter the date of oral disclosure.Information of the type described in thisSection 10.1.f. that is disclosed orally willalso be considered Confidential Informationeven if not later confirmed in writing if theconfidential nature of the disclosure isreasonably apparent to the other party.

idaje zo Stfdie(definovand v 1 1. dasri - UOale zo Stridie,biologickd vzorky a ztznarny Stridie),

idaje z anal.fzbiologickfch vzoriek (definovan6 niZ5ie v11. dasti - UOa.le zo Stridie, biologick6v zorky a zdznarny Stridie),e. dodatok A (RozpodetStfdie a platobnd podmienky) k rejtozmlave, af. v5etky d'alSieinformdcie srivisiace so Stfdiou, liekomspolodnosti Pfrzer alebo s technol6giouzmluvnej vf skumnej or ganizilcie,spolodnosti Pfrzer alebo pobodkyspolodnosti Pfrzer, vjskumnymi aleboobchodnymi pli4nmi, ktor6 zmluvn6vyskumn6 or ganizdcia. spolodnos t pfizeralebo pobodka spolodnosti pfizer poskytnehlavn6mu skri5ajricemu alebo in5titriciipisomne alebo v inej hmotnej podobeaoznaEiza OOVBRNE alebo najprv ristneozndmi a potom zhrnie a potvrdi pfsomneako DOvERNE do 30 dni od ddtumuristneho poskytnutia. Inform6cie uvedendv tejto dasti 10.1.f, ktord sri poskytnutdristne, sa budri povaZovat' za d6vern€,informdcie aj v pripade, Ze nebudri neskOrpotvrdend pfsomne, ak ddverny charakterposkytnutych informdcii je primeranezrejmddruhej strane.

10.2 Wnimky. Medzi dOverndinformdcie nepatria informdcie, ktor6spliajf nasledujrice podmienky

sf verejne dostupnd vdase ich poskytnutia alebo podas platnostipovinnosti zachov 6v af d6vernost'akimkol'vek infm sp6sobom, nei. jeporu5enie tejto zmluvy zo strany in5titricie,b. sf institricii zndtmevdase ich poskytnutia a nepodlieha}f Liadnejpovinno sti zachov 6v at d6vernost'.c. in5titricia ich ziskala

r0.2 Exclusions. ConfidentialInformation does not include informationthat

a. is in the publicdomain at the time of disclosure or duringthe term of this confidentiality obligation bymeans other than breach of this Asreementby Institution,b. is already known toInstitution at the time of disclosure and isfree of any obligations of confidentiality,

is obtained bv

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Institution, free of any obligations ofconfidentiality, from a third party who has a

lawful right to disclose it, ord. is independentlydeveloped, as documented by writtenrecords, by individuals within Institutionwho had no access to ConfidentialInformation.

10.3Data. Also to be identified and treated as

Confidential Information for purposes ofthis Agreement is all Personal Data (as

defined in Section 6.1. Personal Data) thatInstitution collects, processes, stores,

transfers. or uses in connection with theconduct and reporting of the Study.

to.4 Oblieations ofConfidentiality. Unless CRO or Pfrzerprovides prior written consent, Institutionmay not use Confidential Information forany pu{pose other than that authorized inthis Agreement, nor may Institution discloseConfidential Information to any third partyexcept as authorized in this Agreement or as

required by law, including applicableregulations.

a. CRO and Pfizerspecifically authorize any requireddisclosure of Confidential Information toState Institute for Drug Control SUKVIECor regulatory authority representatives.

bez akejkol'vek povinnosti zachov6vat'd6vernost'od tretej osoby, ktor6 m6 zdkonn6pr6vo zverejnit ich, alebod. sri nez6visle vyvinutdjednotlivcami v rdmci in5titricie, ktorfnemajri prfstup k ddvernym inform6ci6m, do

moZno zdokumentovat' pf somnf mizdznamami.

Na ridely tejto zmluvy sa za d6vern6inform6cie budri povaZovat' aj v5etkyosobnd ridaje (tak, ako sri definovand v dasti

6.1 - Osobn6 ridaje), ktord in5titriciaziska,spracuje, uloLi, prenesie alebo pouZijev srivislosti s vykondvanim tejto Stridie a s

pod6vanim hl6senf o Stridii, a bude s nimitakto zaobchddzaf.

10.4 Povinnosti zachovdvatdOvernost' inform6ci(. Pokial' zmluvn6vyskumnd or ganizdcia alebo spolodnost'Pfrzer vopred neposkytne pfsomny sfhlas,in5titricia nesmie pou1iv af d6vern6informdcie naLiadny iny ridel, neZ je ridelschvr4leny v tejto zmluve, ani ich nesmieposkytnrit' tretej strane s vfnimkouschv6lenou podl'a tejto zmluvy a v sflades poZiadavkami pr6vnych predpisov vriitaneprfslu5nych nariadenf.

a. Zmluvndvyskumndorganizilcia a spolodnost Pfizer vyslovneschval'uje potrebu poskytnff d6verndinform6cie SUKL alebo nezdvislej etickejkomisii, pripadne z6stupcom prfslu5n6horesuladn6ho riradu.

Confidentialitv of Personal | 10.3 D6vernost' osobnVch ridajov

b. Permitted uses of b.Study Data and Biological Sample AnalysisData are described in Section 15

(Publications) of this Agreement, and use ofPersonal Data is discussed in Section 6(DataProtection and FDA FinancialDisclosure

Povolen6 spOsobypouiitiaridajov zo Stridie a ridajov z anal'fzbiologickjch vzoriek sri uveden6 v 15. dasti(Publik6cie) a pouZitiu osobnfch ridajov sa

venuje 6. dast'(Ochrana fdajova poskytnutie finandnych ridajov riraduFDA

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10.5 Disclosure Required by Law.If disclosure of Confidential Information byInstitution beyond that expressly authorizedin this Agreement is required by law, thatdisclosure by Institution does not constitutea breach of this Agreement so long asInstitution

a. notifies CRO inwriting as far as possible in advance of thedisclosure so as to allow CRO or pfizer totake legal action to protect its ConfidentialInformation,

b. discloses only thatConfidential Information required to complywith the legal requirement, andc. continues to maintain I c.the confidentiality of this ConfidentialInformation with respect to all other thirdparties.

10.6

Confi dential Information other thanPersonal Data (as defined in Section 6,DataProtection and FDA Financial Disclosure;,Study Data, and Biological Sample AnalysisData (as defined in Section 11, Study Data,Biological Samples, and Study Records),these obligations of nonuse andnondisclosure survive termination of thisAgreement and continue for a period of fiveyears after termination. Confidentialityobligations for Personal Data, Study Data,and Biological Sample Analysis Datasurvive for as long as Institution retains thisinformation, subject to the permitted usesand disclosures described in Sections 6 and15 (Publications) of this Agreement.

Posklrtnutie informdcii na

Ak pr6vne predpisy poZadujri poskytnutiedOvernych inform6cii in5titriciou vo viidSomrozsahu, ako povol'uj e tdto zmluva,nepovaZuje sa tak6to poskytnutie inform6ciiin5titriciou za poruSenie tejto zmluvy zapredpokladu, Ze in5titri cia dodrlinasledujrice podmienky

a. pisomne upozornfzmluvnf vyskumnri organizdciu s donajvld5im predstihom pred poskytnutiminformi4cii tak, aby mohla zmluvndvyskumn6 organizilcia alebo spolodnost'Pfrzer podniknrit'prdvne kroky na ochranusvojich dOvernych inform6cii,b. poskytne iba tieddvern6 inform6cie, ktor6 sf poZadovand nasplnenie z6konnej poZiadavky, a

nad'alej zachovdd6vernost' tychto d6vernfch inform6ciivzhl'adom na ak6kol'vek ind tretie strany.

Povinnost' nepouZfvat' a neposkytovat'd6vernd inform6cie s vynimkou osobnfchfdajov (definovanych v 6. dasti - Ochranafdajov a poskytnutie finandnych ridajovriradu FDA), ridajov zo Stridie aidajov zanal'! z biolo gickych vzoriek (definovanychv 11. dasti - UOaie zo Stridie, biologickdvzorky azinnamy Stfdie) trvd aj poskondeni platnosti tejto zmluvy po dobupiatich rokov odjej skondenia. povinnostizachov 5v af d6vernost' osobnych ridaj ov,fdajov zo Stridie a ridajov z anal'fzbiologickych vzoriek zostane v platnostidovtedy, kfm si in5titticia ponech6 tietoinformdcie v srilade s povolenlimi sp6sobmipouZitia a poskytnutia uvedenymi v 6. a 15.dasti (Publikdcie) tejto zmluvy.

10.5

Survivalof Obligations. For I tO.0

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r of Excellence

informdcii. V pripade pfsomnej Ziadosti

zmluvnej vliskumnej ot ganizdcie in5titriciavr6ti v5etky d6vernd inform6cie, ktor6 m6

alebo riadi, s vynimkou informdcii, ktor6 je

potrebn6 uchov6vat' na mieste vykon6vaniaStridie podl'a prf slu5n6ho nariadenia.

In5titricia si v5ak mOZe ponechat' jeden

rovnopis d6vernych informdcii na

archiv6ciu, aby mohla dokdzat rozsah

povinnost( vyplyvajricich z tejto zmluvy'In5titricia sa okrem toho zavdzuje,i'eposkytne zmluvnej vf skumnej or ganizdcii

na jej poZiadanie sridinnost' apom6Ze jej

zabezpedit vr6tenie d6vernich inform6cii,ktor6 m6 alebo riadi hlavnf skri5ajfci,s vynimkou inform6cif, ktord je potrebn6

uchov6vat'skri5ajricim, a arch(vnej k6pie na

stanovenie rozsahu povinnostf hlavn6hoskri5ajriceho podl'a zmluvy medzi zmluvnou

vfskumnou organizilciou a hlavnYmskriSajfcim.

11. Udaje zo Stridie. biologick6 vzork)'azilznamv St'6'die

Udaje zo Stridie. HlavnY

skri5ajrici sazvdztie, Ze podas Stfdiezhromaidi urdit6 ridaje, ako je uvedend

v protokole, apredloli ich zmluvnejvyskumnej organizdcii (d'alej len ako ,,ridaje

zo Stridie"). Hlavnli sku5ajrici zabezpeili

presnd a vdasnd zluoma1tovanie,zaznamenfvanie a predkladanie ridajov zo

Stridie v r 6tane dodrZi avania vdasnostizaznamenfvani a ri daj ov uvedenf ch

v dokumente, ktor'.i poskytne zmlwndvyskumnd or ganiz6cia vYPlnenie

elektronicky ch zdznamovych formuldrovridastnfta skri5ania eCRF.In5titricia poskytne

sridinnost'hlavndmu skri5ajricemu, ak a ako

bude potrebn6 umoZnit' hlavndmuskri5 aj ricemu dodrZiavanie tej to povinno sti.

Information. If requested by CRO inwriting, Institution will return allConfidential Information in its possession orcontrol except that required to be retained at

the Study site by applicable regulation.However, Institution may retain a single

archival copy of the ConfidentialInformation to determine the scope ofobligations incurred under this Agreement.

Institution further agrees to cooperate withCRO, on request, to help ensure return ofConfidential Information in the possession

or control of Principal Investigator, except

for that required to be retained by an

investigator and an archival copy fordetermining the scope of PrincipalInvestigator' s obligations under the

agreement between CRO and PrincipalInvestigator.

11.

Studv Records

11.1 Study Data. During the

course of the Study, Principal Investigatorhas agreed to collect certain data, as

specified in the Protocol, and submit it toCRO ("Study Data"). Principal Investigatorwill ensure accurate and timely collection,recording, and submission of Study Data,

including adhering to timelines for data

entry set out in the CRO-provided eCRFCompletion Guidelines document.

document. Institution will cooperate withPrincipal Investigator if and as needed tofacilitate compliance by PrincipalInvestigator with this obligation.

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Excellence

Data. Subject to Principal Investigator'sright to use Study Data to publish the results

of the Study (see Section 15, Publications),Pfrzer is the exclusive owner of all Study

Data-

b. Medical Records.

Study Subject-related medical records that

are not submitted to cRo may include some

of the same information as is included inStudy Data; however, neither CRO nor

Pfizer makes any claim of ownership to

those documents or the information they

contain.

Data Review by

CRO. CRO will review the Study Data itreceives on an ongoing basis. CRO willcomply with applicable regulationsrequiring notification of participatinginvestigators of new safety informationabout the Pfizer Drug (as defined in Section

8 of this Agreement). CRO has furthercommitted to notify Principal Investigator ofany other new information of which CRO

becomes aware that could affect the safety

of the Study Subjects or influence the

conduct of the Study. Principal Investigator

has agreed to share information received

from CRO under this Provision withInstitution

d. Study Results. After d.

analysis of Study Data from all sites is

complete, CRO will provide PrincipalInvestigator with a summary of the overall

results of the Study, and PrinciPalInvestigator has agreed to share this

summary with Institution. If within two

Stfdie. Vzhl'adom na pr6vo hlavndho

skfsajriceho pourlivat idaie zo Stridie na

publikovanie vysledkov Stridie (pozri 15.

dast' tejto zmluvy, Publik6cie) spolodnost'

Pfizer je vyhradnfm vlastnikom v5etkychridajov zo Stridie.

b. Zdravotnd zdznarrry-

Zdravotnd zdznamy subjektov Stridie, ktor6

nebudri predloZend zmluvnej viskumnejor ganiz6cli, mOZu obsahovat' niektordinformdcie, ktor6 sri rovnak6 ako inform6cie

zahrnutd v ddajoch zo Stridie. Zmltvnfvjskumnd or ganizdcia ani spolodnost' Pfizer

si v5ak napriek tomu nerobiaLiaden ni4rok

na vlastnictvo tfchto dokumentov ani

informdcii. ktord obsahui f .

c. Kontrola ridajovzmluvnou v:f skumnou organiz6ciou.Zmltx nd vy skumn6 or ganizdcia aleb o

spolodnost' Pfrzer bude priebeZne

kontrolovat' prriat€idaje zo Stridie. Zmlwn6vyskumnd or ganizdcia bude dodrZiavat'platn6 nariadenia, ktor6 vyZadujf, aby

zridastnenych skriSajricich obozndmilas novymi inform6ciami o bezpednosti liekuspolodnosti Pfizer (v sflade s definiciou v 8.

dasti tejto zmluvy). Zmltvnd vyskumndorganiz6cia sa d'alej zavdzuie,Le obozndmi

hlavndho skri5ajriceho so v5etkymi novymiinform6ciami, o ktot'ch sa dozvie a ktor6

by mohli ovplyvnit' bezpednost' subjektov

Stridie alebo vykon6vanie Stridie. Hlavnyskri5aj rici sa zav dzuje. Ze poskytne in5titf ciiinform6cie ziskand od zmluvnej viskumnejor sanizdcie na zdklade tohto u stanoveni a.

dokondeni anal'fzy ridajov zo Stridie zo

v5etkfch pracovfsk zmluvn6 vyskumn6or ganiz6cia po skytne hlavndmuskri5aj ricemu sfhrn celkovich vf sledkov

Stfdie a hlavnV skri5airici sazavrazal, Le

ne tento srihrn in5titticii. Ak do dvoch

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r of Excellence

rokov od dokondenia Stridie spolodnosfPfrzer zisti vfsledky, ktor6 by mohliovplyvnit' bezpednost' subjektov Stridie,

zmluvnd vy skumn6 or ganizdcia aleb-o,

spolodnost'Pfrzer po konzultdcii so SUKLalebo nez6vislou etickou komisiou, ak tobude vhodnd, v spolupr6ci s hlavnfms kf 5 aj rici m al eb o i n Stitticiou zab ezp eEi, aby

tieto vysledky hlavny skri5ajrici alebo

in5tifiicia primerane ozn6mila subjektomStfdie.

Biolosickd vzorkv. V srilade

s protokolom a dokumentom informovan6hosrihlasu smie hlavny skri5ajricizhromaLd ovat' a poskyovat' zmluvnejvyskumnej organizdcli alebo osobe

poverenej zmluvnou viskumnouorganizilciou biologick6 vzorky (napr. krv,mod, tkanivo, sliny atd'.) ziskand od

subjektov Stfdie na testovanie, ktor6 sa

priamo netyka starostlivosti o subjekt Stridie

alebo monitorovania bezpednosti, naprftladfarmakokinetick6, farmako genomick6 alebo

biomarkerovd testy (d alej len ako

,,biologickd vzorky").

a. PouZitie. In5titricianebude pouLivat biologick6 vzorky ziskand

v srilade s protokolom Ziadnym inymsp6sobom ani na Liadny iny ridel, akojepopisan6 v protokole . Zmhtvnd viskumndorganizdcia a spolodnost Pfizer pouZijfbiologick6 vzorky iba sp6sobmi povolenymiv dokumente informovan6ho srihlasu, na

zdkJade ktor6ho boli ziskan6.

Zml:u nd vyskumn6 or ganizdcia, spolodno st'

Pfrzer alebo nimi poveren6 osoby budri

testovat' biologick6 vzorky v srilade

s protokolom. Pokiall nie je v protokoleuvedend inak, zmluvn6 vyskumndor ganizdcia neposkytne vysledky tychtotestov (d'alej len ako ,,ridaje z anal'fz

vzoriek") hlavndmu

years after Study completion Pfizeridentifies results that could affect StudySubject safety, CRO or Pfizer, inconsultation with the SUfVIEC as

appropriate, will cooperate with Principa-Investigator or Institution to ensure thatthose results are appropriatelYcommunicated to the Study Subjects byPrincipal Investigator or Institution.

ll.2 Bioloeical SamPles. If so

specified in the Protocol and the informedconsent document, Principal Investigatormay collect and provide to CRO or CRO'sdesignee biological samples obtained fromStudy Subjects (e.g., blood, urine, tissue,

saliva, etc) for testing that is not directlyrelated to Study Subject care or safety

monitoring, such as pharmacokinetic,pharmaco genomic, or biomarker testing("Biological Samples").

a. Use. Institution willnot use Biological Samples collected underthe Protocol in any manner or for anypurpose other than that described in the

Protocol. CRO and Pfrzer will use

Biological Samples only in ways permittedby the informed consent under which theywere obtained.

b. Analysis Data. CRO,Pfizer, or their designees will test BiologicalSamples as described in the Protocol.Unless otherwise specified in the Protocol,CRO will not provide the results of these

tests ("Biological Sample Analysis Data') tothe Principal Investigator, Institution, orStudy Subject. If CRO does provide

Analvsis Data to the

SWP_CSA 3 (a)-Institution-Slovakia01 September 2013B148i038_ Liptovskd nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskli Mikul45-site 2172-Kycina

PagelT of 66

Principal Investigator, that data will besubject to the provisions of Section I 1.1

(Study Data) of this Agreement.

c. Ownership. Pfizer isthe exclusive owner of all BiologicalSamples and Biological Sample AnalysisData.

1 1.3 Study Records. Institution, onbehalf of Principal Investigator and itself,will retain each Study Subject's Studyrecords, which include the PrincipalInvestigator's copies of all Study Data as

well as relevant source documents(collectively, "Study Records"), understorage conditions conducive to theirstability and protection, for a period of 15

years after termination of the Study unlessCRO or Pfizer authorizes, in writing, earlierdestruction. Institution asrees to contactPfizer atprior to destroying any Study Records andfurther agrees to permit Pfrzer to ensure thatthe Study Records are retained for a longerperiod if necessary, atPfizer expense, underan arrangement that protects theconfidentiality of the Study Records (e.g.,

secure off-site storage).

l2.l Monitoring. CRO intends tomonitor Study conduct. Pfizer has the right,but not the oblisation. to co-monitor theStudv. Upon reasonable notice and duri

skri5ajricemu, in5titricii ani subjelm Snfdie-Ak zmluvnr4 vyskumn6 orgenizAciTposkytne idaje z analyz biologickjctvzoriek hlavn6mu skri5ajricemu, tieto ridajebudri podliehat'ustanoveniam dasti I l-l(Udaje zo Stfdie) tejto zmluvy.

c. Vlastnictvo.Spolodnost' Pfizer je vyhradnym vlastnikomv5etkych biologickych vzoriek a ridajovz analyz biologickfch vzoriek.

11.3 Zaznamy Stu'die. V mene hlavndhoskri5ajriceho a za seba bude in5titriciauchov6vat'v5etky zdznamy o subjekte Stfdietfkajfce sa tejto Stridie, ku ktorym patria ajkSpie hlavn6ho skf5ajfceho v5etkychridajov zo Stfdie, ako aj prislu5nd zdrojov6dokumenty (d alej len spolodnlm n6zvomako ,,zdznamy Stridie") v podmienkachuchov6v ani a zabezpelujricich ich stabilitua ochranu po dobu 15 rokov od ukondeniaStfdie, pokial' zmluvnd vyskumndor ganiz{cia alebo spolodnost' Pfizerpfsomne neschv6li ich skor5ieznehodnotenie. In5titricia sa zavdzuje, Le sa

pred znehodnotenfm akychkol'vekzflznamov Stfdie skontaktuje so

spolodnost'ou Pfizer pomocou e-mailovejadresy ) a

zavdzaje sa tieZ, Le v pripade potrebyumoZni spolodnosti Pfrzer zaistit na n6kladyspolodno sti Pfrzer uchovanie zdznamovStridie po dlh5iu dobu, pridom musia byfpodniknut6 tak6 opaffenia, ktord budrichr6nit' dOvernj charakter zdnnamov Sttidie(napr. bezpeln€, uchovanie mimopracoviska).

t2 Monitorovanie. kontroly a audityt2.

12.l Monitorovanie. Zmluvnavyskumnd organizdcia m6 v rimyslemonitorovat' vykon6vanie Stf die.

lodnost' Pfizer m6 pr6vo, nie v5ak

A Srrr$d d Erce{lence

SWP_CSA 3 (a)-Institution_Slovakia0l September 201381481038_ Liptovsk6 nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskj Mikuld5-site 2172-Kycina

Page 18 of 66

r A Swnbol of Excellonce

regutar Uosiness hours, Institution willsentatlves access

facilities, StudY

and research

staff as required to monitor Study conduct'

CRO will PrInvestigator that

could affect s or

influence the conduct of the StudY.

Principal Investigator has agreed to share

this information with Institution and may

inform Study Subjects of such findings as

appropriate.

Institution acknowledges that the Study is

subject to inspection by regulatory

authorities worldwide, including the United

States FDA, and that such inspections may

occur after completion of the Study and may

include auditing of Study Records. CRO or

Pfrzer may also audit Study Records during

or after the Study as part of its monitoring of

Study conduct.

[ov inno st', v yko n6v at' srib e Zni mo nitori n g

Stfdie. Po primeranom ozn6meni a podas

hlavndmu skriSaiticemu Prl

beZn6ho pracovn6ho dasu umoZni in5titticia

z6stupcom zmluvnej viskumnej or ganizilcie

alebo spolodnosti Pfrzer vstup do priestorov

a zaiadeni in5titticie, prf stup k zdznamom

Sfiidie, skri5ajricim a viskumndmu person6lu

ak6kollvek zistend vf sledky monitorovania,ovPlYvnit' bezPednost'

ania alebo vYkon6vanie

skri5ajrici sa zaviazal, Le

poskytne informdcie in5titricii a v prfpade

potreby mOZe informovat' subjekty Stridie

o takfchto zisteniach.

t2.2 Inspections and Audits. t2.2 In5titricia

Institution will notify CRO, or confirm that

Principal Investigator has done so, as soon

as reaionably possible if the site is inspected

or if Institution learns that it is scheduled to

be inspected by a regulatory authority in

relation to the StudY.

b. CooPeration'

Institution will cooperate with regulatory

authority and CRO or Pfizer representativesanY such

tution will also

estigator in

berie na vedomie, Ze Stfdia podlieha

kontrole reguladnych riradov na celom svete

vr6tane americk6ho riradu FDA a Ze sa

tak6to konffoly m6Zu konat' aj po dokondeni

Stridie a ich sridast'ou m6Ze byf audit

zfnnamov Stridie' Zmltl.v nd vi skumn6odnost' Pfizet m61e

namov Stridie Podas6mci monitorovania

vykon6vania Stfdie.

q Oznamovacia

riradom v srivislosti so Stridiou napl6novan6,

alebo potvrdi,Le to hlavnf skri5ajrici urobil'

a. Notification.

ensuring, that Study Records are maintained

Page 19 of66

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in a way that facilitates such activities. toho, aby boli zdznamy Stfdie uchovandsp6sobom, ktorf tak6to dinnosti umoZiuie.

c. Resolution ofDiscrepancies. Institution will cooperatewith Principal Investigator in the promptresolution of any discrepancies that areidentified between the Study Data and theStudy Subject's medical records.

d. Inspection Findingsand Responses. Institution will promptlyforward to CRO, or confirm that principalInvestigator has done so, copies of anyinspection findings that Institution receivesfrom a regulatory authority in relation to theStudy. Institution will also cooperate withPfrzer as needed to help ensure thatPrincipal Investigator forwards anyinspection findings that PrincipalInvestigator alone receives in relation to theStudy. Whenever feasible and permitted bylaw, Institution will provide CRO with anopportunity to prospectively review andcomment on any Institution responses toregulatory authority inspections in regard tothe Study.

13. Remedies for Breach of CertainStudy Obligations. In the event Institutionfails to comply with any of its obligationsset out in Sections 3 (Protocol), 7 (InformedConsent and Subject Recruitment), 1l(Study Data, Biological Samples, and StudyRecords) and 12 (Monitoring, Inspections,and Audits) of this Agreement, or therequirements of the Protocol relating toadverse event reporting, ethical conduct ofthe Study, anO SUKUIEC review, orPrincipal Investigator fails to comply withany of hisftrer comparable obligations in theagreement between CRO and PrincipalInvestigator, the following will apply. In

c.In5titricia poskytne hlavn6mu shisajricemusf dinnost' pri rychlom vyrie5enfakychkol'vek rozporov zistenf ch medzifdajmi zo Stfdie azdravotn'(mi zdznamamisubjektu Stridie.

d. Ndlezv kontrolva reakcie na ne. In5titfcia bezodkladneodo5le zmluvnej vyskumnej or ganizilciikSpie aklichkol'vek zisteni kontroly, ktorddostane od reguladndho riradu v srivislosti soSfiidiou, alebo potvrdi, Le to urobil hlavnyskfSajfci. In5titricia tie? v pripade potrebyposkytne sridinnost' spolodnosti pfizera pom6Ze jej zaistif , aby hlavny skf5ajriciposlal ak6kol'vek zistenia, ktor6 dostane s6mhlavny skri5ajrici v srivislosti so Stridiou.YLdy, ak to bude molnd a ak to budriumoZf,ovat' prdvne predpisy, in5titriciaposkytne zmluvnej vyskumnej ot ganizlciiprileZitost' perspektfvne upravit'a komentovat' akdkol'vek reakcie in5titriciena kontroly reguladndho riradu v srivislostiso Stridiou.

13. Opravn6 prostriedky pri poruSenfniektorVch povinnosti v r6mci Strfdie. Vprtpade, Ze in5titricia nedodrLi niektorf zosvojich povinnostf uvedenych v 3. dasti(Protokol), 7. dasti (InformovanV srihlasa n6bor subjektov), 11. dasti (tJdaje zoStfdie, biologickd vzorky a z1znamy Stridie)a 12. (,asti (Monitorovanie, kontrolya audity) tejto zmluvy alebo poZiadavkyprotokolu tfkajrice sa hl6senia neZiaducichudalosti, etick6ho vykondvania Stridiea kontroly SUKI- alebo nezilvislej etickejkomisie, alebo ak hlavny sku5ajrici nedodrliniektoni z jeho obdobnllch povinnostfvyplyvajf c ich zo zmluvy medzi zmluvnou

addition to its right to terminate the Stud vVskumnou iz1ciou a hlavnVm

Excellence

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Page20 of66

I A Svmbol of lxcellence

immeOiatety under Section 18.1.c(2), CRO stuSa.lricim , plati nasledujrice Zmlwnfvyskumn6 orgpr6va okamZit18.1.c bod (2)

nasledujrice n6Pravn6 oPatrenia:

a. pozastavenie zarad'ovania subjektov

Stfdie. ak do Stridie e5te nebol zarudeny pln'!

will have recourse to either or both of the

following alternative remedies :

a. Suspension of StudY Subject

enrollment, if the Study is not yet fullyenrolled, and

b. SusPension of PaYment to

Institution and Principal Investigator

Any suspension of enrollment or payment

will continue until Institution and Principal

Investigator return to compliance with their

Study obligations, as determined by CRO'

Use of either or both of the above remedies

does not preclude CRO or Pfizer fromexercising its right to immediately terminate

the Study if Institution and Principal

Investigator do not both become compliant.

podet subjektov, a

b. pozastavenie platieb in5titric

a hlavndmu skri5ajf cemu

Ak6kol'vek pozastaven ie zatat ov ania alebo

platieb bude pretrvdva(, aL kfm hlavny

skri5ajrici a in5titricia neza(ni znova

dodrZiavat' svoje zdvdzky v r6mci Stfdie tak,

ako je urden6 zmluvnou vYskumnou

organiz6ciou. PouZitie jedndho alebo

obidvoch vySSie uvedenich n6pravnfch

opatren( nebr6ni zmluvnej vyskumnej

organizilch ani spolodnosti Pfizer, aby si

uplatnili svoje pr6vo okamZite ukondit'

Siridiu, ak hlavnf skri5ajrici a in5titricia opiit'

neuvedie svoje konanie do sriladu so

zmluvou.

14. Vvn6lezy

l4.l Oznamovacia Povinnost'' Akje vjsledkom vykon6vania Stridie akykol'vek

patentovany alebo nepatentov any vyn6iezalebo objav (dalej len ako )tyn6lez"),o ktorom bude in5titricia vediet', bude o iomin5titricia bezodkladne informovat' zmluvnfvf sku mnri or ganizdciu.

14.2postripi v5etk

Postripenie Pr6va. In5titticiay pr6va na takyto vYnillez

spolodnosti Pfizer bez akdhokollvek zdv'azku

di rihrady, ktor6 nie sf upraven6 touto

zmluvou, alebo zaistf, aby jej autori

vyn6lezu v5etky tak6to pr6v a posttipili.

t4.

14.1

Inventions

Notification. If the conduct

of Study results in any invention ordiscovery of which Institution is aware,

whether patentable or not ("Invention"),

Institution will promptly inform CRO.

14.2 Assignment. Institution willassign, or ensure that all inventors who are

employees or contractors of Institutionassign, all interest in any such Invention to

Pfrzer, free of any obligation or

consideration beyond that provided for inthis Agreement.

t4.3 istance. Institution will | 14.3 . In5titricia poskvtne

Page2l of 66

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-

d Ercellencespolodnosti mzfr prim- r-- gipod6vani patentovej 1rtl$l e tci usrivislosti s fiou, do satfrer1fu-ffbmvydavky hradf spolodnost' Pfu-

15. Publik6cie. Spoloinct'PfiEpodporuje uplatiovanie akademic*cjslobody a nebude mat' vyhrady, ak h&hlavny skf5ajfci publikovar vjsledg trdiena ziklade informdcif , Lo16 r66ma;rti I

alebo vytvoril,bez ohl'adu na to, di sri ,

vfsledky priaznivd pre liek spolodnostiPfizer. PoZiadavky srivisiace s takoutopublikriciou sri uveden6 v 15. dasti(Publik6cie) zmluvy medzi zmluvnouvyskumnou organizdciou a hlavnSTmskf Sajfcim. Spolodnosf Wizer tiei,zaregistruje Stfdie, ktorfch je zaddvatelom,na injch zoznamoch prebiehajricich Stridiivedenych prfslu5nymi reguladnfmi riradmiv pripade, kde sa to vyZaduje nazdkladereguladnej poZiadavky.

I6Od5kodnenie a poistenie. Zmluvni{

vyskumn6 or ganizdcia neposkytne Liadneod5kodneni e na zSklade tejto zmluvy.Spolodnost' Pfizer poskytne in5titriciia hlavn6mu ski5ajricemu od5kodneniesrivisiace so Stridiou sp6sobom uvedenfmv dodatku B, Formuli{r od5kodnenia.Spolodnost' Pfizer bude tieZ poskytovat'poistenie typu a do takej mieryzodpovednosti, ktord sri vhodnd preokolnosti ochrany proti ni4rokom aleboz6vdzkom, ktor6 mOZu vyplynrit' ztejtozmluvy, vr6tane ni4rokov od subjektovStfdie alebo v ich zastripenf srivisiacichs ujmou nazdravi v d6sledku vliskumu, akoje definovand v dodatku B. Po p(somnejZiadosti poskytne spolodnost' Pfrzerin5titricii potvrdenie, ktor6 dokazuje takdtopoistnd krytie.

In5titticia a hl skri5aifci sri vedni

SWP_CSA 3 (a)_Institution_Slovakia0l September 2013B 1481038- Liptovskd nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskj Mikul6i_site 2172_Kycina

provide reasonable assistance to Pfizer infiling and prosecuting any patentapplications relating to Invention, at Pfizer'sexpense.

15. Publications. Pfrzer supports theexercise of academic freedom and has noobjection to publication by PrincipalInvestigator of the results of the Study basedon information collected or generated byPrincipal Investigator, whether or not theresults are favorable to the Pfrzer Drug.Requirements associated with suchpublications are set forth in Section 15(Publications) of the agreement betweenCRO and Principal Investigator. Pfizer willalso register Pfizer-sponsored studies onother listings of ongoing studies maintainedby competent regulatory authorities wherethere is a regulatory requirement to do so.

16.

CRO does not provide any indemnificationunder this Agreement. Pfizer will providean indemnity to the Institution and thePrincipal Investigator in respect of the Studyin the form contained in Attachment B,Form of Indemnity. Pfrzer will alsomaintain insurance coverage of the type andwith liability limits appropriate to thecircumstances to protect against claims orliabilities that may arise under thisAgreement, including claims from or onbehalf of Study Subjects relating toResearch Injury, as that term is defined inAttachment B. Upon written request, Pfizerwill provide Institution with a certificatedocumenting this coverage.

The Institution and Principal Inves

Page 22 of 66

.etttait ."sponsible in circumstances where

personal injury or illness to the Study

Subject arises by the failure of the

Institution, Principal Investigator, or either

of their employees or agents to conduct the

Study without negligence and in accordance

with the Protocol.

The Institution acknowledges that neither

CRO nor Pfrzet will be responsible for and

the Institution and Principal Investigator

agree, to the extent allowed by law, to

indemnify and hold CRO and Pfizetharmless from any loss, claim or demand

arising from any injuries or damages

resulting to the Institution and/or Principal

Investigator's negligence, failure to adhere

to the Protocol, failure to obtain informed

consent. unauthorized warranties, breach ofthis Agreement or willful misconduct'

za pripady u;my nazdtavi alebo ochorenie

subjektu Stridie, ktord vznikne v dOsledku

nedbal6ho vikonu Stridie alebo z vykonu

Stridie in5titriciou, hlavnym skri5ajf cim

alebo jej zamestnancami a z6stupcami(vr6tane hlavn6ho skri5ajriceho) v rozpore

s protokolom.

In5titricia berie na vedomie, Le ani zmluvnd

vyskumn6 or ganizdcie ani spolodnost' Pfizer

nenesri zodpovednost' a in5titricia a hlavnf

skri5ajrici sti

povolendho kumnd

organizdcia enesf

zodpovedn osf za od5kodneni e alebo za

straty, ndroky alebo poZiadavky vodi

zmluvnej vyskumnej ot ganizilclia spolodnostiPfrzet, z dOvodu ujmy na

zdravi alebo Skody sp6sobend nedbalim

r7.

t7.l

Assienment and Delegation

Bv Institution. CRO

authorizes Institution to delegate Institution

duties under this Agreement to Principal

Investigator as appropriate' Institution may

not otherwise assign its rights or delegate or

subcontract any duties under this Agreement

without written permission from CRO. IfCRO authorizes delegation or

subcontracting, Institution remains

responsible to CRO for the performance ofall delegated or subcontracted duties'

zmluvy alebo rimYselnYm konanfm'

17. PostfPenie a Poverenie

InStitriciou. Zmluvnflt7.rvyskumnd or ganiz6cia opr6viuj e in5titrici u

delegovat' jej povinnos ti na zilklade tejto

zmluvy v pr(pade potreby na hlavn6ho

skri3aj riceho. In5titricia nesmie po stripit'

Liadne prdva ani delegovat Liadne

povinnosti nazdklade tejto zmluvy ani

:uzav''iet na ich vykon6vanie zmluvu so

subdod6vatellom bez pfsomn6ho srihlasu

zmluvnej viskumnej organizdcie. Akzmluvn6 vy skumnd or ganizilcia povolf

delegovanie povinnostf na ini subjekt alebo

uzavretie zmluvy so subdod6vatellom,

in5titricia bude nadalej zodpovedn6 vodi

zmluvnej vliskumnej organizilcii za vykon

v5etkjch delegovanich povinnosti alebo

innostf, na vykon6vani bola

Page23 of 66

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B1481038_ Liptovsk6 nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskli Mikuld$-siteZl72-Kycina

A Symbol of Excellence

d Excellence

17.2 By CRO. CRO may freelyassign any or all ofits rights and delegateany or all of its duties under this Agreementto Pfizer. If CRO assigns all rights anddelegates all duties toPfrzer, CRO or Pfizerwill notify Institution in writing. CRO (orPfizer, following assignment and delegationby CRO) may also freely delegate andassign Study-related duties and rights to anexternal provider upon advance notice toInstitution, and may freely delegate orassign its Study-related duties or rights toany Pfizer affiliate. CRO may not otherwiseassign its rights or delegate its duties underthis Agreement without written permissionfrom Institution. If CRO or Pfizer delegatesor subcontracts any duties, CRO or Pfrzerremains responsible to Institution for theperformance of those duties.

18. Termination

18.1 Termination Events.Termination of this Agreement will betriggered by the earlier of any of thefollowing events.

azawetd zmluva s() drrlnrgr-Irrr

17.2 Zmluvnovfuor gani zdciou . Tmluv ni vfsUnUorganizdcia mOZe slobodne pcn4nr'ktor6kol'vek zo svojich prr6v a*gotzktordkol'vek zo svojich povinnmfvyplyvaj f c ich z tejto zmluvy na spolfusPfizer. Ak zmluvnd vyskumnd organizffiapostripi v5etky pr6va a deleguje vSetkypovinnosti na spolodnost' Pfizer, zmluvn{vyskumnd or ganizdcia alebo spolodnosr'Pfizer to oznilrni pfsomne in5titricii.Zmluv nd vf skumn 6 or ganizdcia ( alebospolodnost'Pfrzer po postripeni a delegovanfzmluvnou vyskumnou or ganizdciou) m6Zeslobodne po predch6 dzajicom ozndmeniin5titricii delegovat' alebo postripit'povinnosti aprdva srivisiace so Stridiou naexterndho poskytovat el a a mdile slobodnedelegovat' alebo postripit' svoje povinnostiaprixa tykajrice sa Stridie na akrikol'vekpobodku spolo dno sti Pfrzer . Zmluv ndvyskumnd or ganiz6cia nesmie postripit'Liadne prdva ani delegovaf Ziadnepovinnosti nazilklade tejto zmluvy bezpisomn6ho srihlasu in5titricie. Ak zmluvn6vyskumnd or ganizdcia alebo spolodnost'Pfrzer deleguje akdkol'vek povinnosti alebouzavie na ich zabezpedovanie zmluvu sosubdoddvatel'om, zmluvnd vyskumndor ganizflcia alebo spolodnost' Pfizer budenad'alej zodpovedn6 vodi in5titricii zavykon6vanie tf chto povinnostf .

18. Ukondenieplatnosti

18.1 Udalosti vedrice k ukondeniuplatnosti. Tdto zmluva bude ukondendktoroukol'vek z t!chto udalosti podl'a toho,ktor6z nich nastane skdr.

Nesrihlas SUKI-alebo nez6vislej etickej komisie. Ak StridiunemoZno zaEaf z d6vodu nesrihlasn6ho

a. Disapproval bySUKUIEC. If the Study cannot be initiitiatedbecause of IRB/IEC di al, this

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Page ?A of 66

A Symbol of Excellonce

Asreement will terminate.

b.

This Agreement will terminate when the

Study is complete, which means the

conclusion of all Protocol-required activitiesfor all enrolled Study Subjects.

c. Earlv Termination ofStudy. This Agreement will terminate if the

Study is terminated early as described

below.

11) Terminationof Study Upon Notice. CRO or Pfizer may

terminate the Study for any reason upon 30

days' written notice to PrinciPalInvestieator.

stanoviska SUfI- alebo nezdvislej etickej

komisie, bude t6to zmluva okamZite

ukonden6.

b. Dokondenie Stridie.

T6to zmluva bude ukonden6 dokondenimStfdie. Eo znamend dokondenie v5etkych

dinno st( poZadov any ch na zdklade protokolu

v pr(pade v5etkych subjektov zaradenycb do

Stfdie.

c. Preddasn6 ukondenie

Stfdie. Tdto zmluva bude ukondend pripreddasnom ukondenf Stridie v pripadoch

uvedenych dalej.

rl \ UkondenieStridie na z6klade ozndmenia' Zmh;.v nd

v j skumn6 or ganizlcia alebo spolodnost'

Pftzer mdZe ukondit'Stridiu z ak6hokol'vekd6vodu pisomnym ozndmenim hlavndmuskri5ajricemu s vipovednou lehotou 30 dnf.

(2)Termination of Study by CRO or Pfizer.

CRO or Pfizer may terminate the Studyimmediately upon written notice to Principal

Investigator for causes that include failure toenroll Study Subjects atatate sufficient toachieve Study performance goals; material

unauthorized deviations from the Protocolor reporting requirements ; circumstances

that in CRO's or Pfizer's opinion pose risks

to the health or well-being of StudySubjects; regulatory authority actions

relating to the Study or the InvestigationalDrug; any non-compliance by the PrincipalInvestigator with local laws. ICH GCP, orthe terms of Section 20 of this Agreement,;or non-compliance by the PrincipalInvestigator with the comparable terms ofthe agreement between CRO and PrincipalInvestigator.

OkamLitdukondenie Stfdie zmluvnou v'fskumnouorqanizdciou alebo spolodnost'ou Pfizer.Zmlw n6 vyskumn6 or ganizdcia alebo

spolodnost' Pfizer mdZe ukondit' Stridiu

okamZite po pfsomnom ozndmenf hlavndmu

skri5ajfcemu z dOvodov, medzi ktor6 patrf:

nezaradenie dostatodn6ho podtu subjektovStridie na dosiahnutie ciel'ov Stridie; z6vaLn6

nepovolen6 odchylky od protokolu alebo

poZiadaviek nahlasovania; okolnosti, ktordpodl'a ndzoru zmluvnej vYskumnejorganizdcie alebo spolodnosti Wizer m6Zu

predstavovat' riziko ohrozenia zdravia alebo

pocitu zdravia subjektov Stridie; krokyreguladndho riradu v srivislosti so Stridiou

alebo skri5anjm liekom; alebo akdkol'veknedodrZiavanie miestnych pr6vnychpredpisov hlavnym skri5ajf cim. Smernice

Spr6vnej klinickej praxe konferencie ICHalebo podmienky v 20. dasti tejto zmluvy,

alebo nedodrLiavanie ich

Immediate I tZl

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Non-compliance with Section 20 wouldinclude circumstances where CRO or Wizerbecome aware (a) that improper paymentsare being or have been made to GovernmentOfficials (as defined in Section 20) or anyother person by the Institution or thoseacting on behalf of the Institution withrespect to services performed on behalf ofPfizer, or (b) that the Institution or thoseacting on behalf of the Institution withrespect to services performed on behalf ofPfizer has accepted any payment, item, orbenefit, regardless of value, as an improperinducement to award, obtain, or retainbusiness or otherwise gain or grant animproper business advantage from or to anyother person or entity.

Institution may terminate the Studyimmediately upon notification to CRO ifrequested to do so by the responsibleSUKL/IEC or if such termination is requiredto protect the health of Study Subjects.

18.2 Effective Date of AgreementTermination. If termination of theAgreement is triggered by any of the eventsdescribed in Section 18.1, above, thetermination will be effective after receipt byCRO of all Protocol-required Study Dataand Biological Samples generated up untiltermination; receipt of all payments due toeither party; and completion by both partiesof any remaining applicable Agreement

podmienok zmluvy medzi zmluvnouvfskumnou organizdciou a hlavnfmskfSajricim.

NedodrZiavanie povinnostf podl'a 20. dastisa vzt'ahuje na okolnosti, kedy sa zmluvndvfskumn6 or ganizdcia alebo spolodnost'Pfizer dozvedia (a) o vykonanineprimeranf ch platieb Stdtnym riradnikom(podl'a 20. dasti) alebo inej osobe in5titricioualebo osob6m konajfcim v mene in5titricie vsrivislosti so sluZbami vykondvanymiv mene spolodnosti Wizer alebo (b) o tom,Ze in5titricia a osoby konajrice v menein5titricie v srivislosti so sluZbamivykondvanfmi v mene spolodnosti Pfrzerprijali platbu, predmet alebo vyhodu bezohl'adu na jej hodnotu ako neprimerandovplyvnenie na udelenie, ziskanie aleboudrZanie si obchodnej prfleZitosti alebozfskanie vlihody od inej osoby alebosubjektu alebo poskytnutie neprimeranejobchodnej vfhody tejto inej osobe pripadnesubjektu.

ukondenie Strfdie zo strany in5titricie.In5titricia m0Ze okamZite ukondit' Stridiuozni4menim zmluvnej vyskumnejorganizdcli. ak to poZaduje kompetentnliSUKL alebo nezdvisl6 etickd komisia aleboakje ukondenie potrebnd na ochrana zdraviasubjektov Stfdie.

platnosti ukondenia zmluvy. Ak je prfdinouukondenia platnosti zmluvy niektor6z udalosti uvedeny'ch v dasti 18.1, budeukondenie platn6 od okamihu, ked'zmluvndvfskumnd orgarnzilcia dostane v5etky ridajezo Stridie a biologickd vzorky poLadovandnazikJade protokolu a vytvorend dookamihu ukondenia zmluvy, po dorudenfv5etkjch splatnych platieb ktorejkol'vek zozmluvnjch str6n a po tom, ako obidve

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Page26 of66

lduvn6 strany sPlnia v5etkY svoje

zo st6v aiice p ovi nno sti v y ply v ajice zo

zmluvy.

zmluvn6 vyskumn6 or ganizilcia nevyd6 iny

pfsomny pokyn, in5titricia po ukondenf . .

ukondeni Stridie. Pokiall nie je inak uvedene

u tqto dasti, pri preddasnom ukondeni Stfdie

zaplati zmluvn6 vi sku mnd ot ganiz6cia za

pti"u vykonanf do tohto momentu v srilade-<lodatkom

A po odpodftan( platieb,ktotdtLbo\i zatrito pr6cu uhraden6' Zmh;lv n6

vf skumn6 or ganizilcia tieZ uhradf v5etky

nlzruSitel'nd vidavky s vynimkou budricich

ndkladov na pracovnkov, za predpokladu,

Ze tieto vidavky boli riadne vynaloZend

a vopred schv6lend zmluvnou vyskumnou

organiz6ciou, len v takom rozsahu, v ktorom

imnie je moZn6 zabtdnit. Ak Stridiu nie je

mohn6 zaEat z d6vodu nesrihlasndho

stanoviska SUfI- alebo nez6vislej etickej

komisie bez viny zo sffany in5titricie,

zmluvn6 v y skumn6 ot ganizdcia1hrad iinstitricii poplatky vyplaten6 SUKL alebo

nez6vislej etickej komisii, ktor6 vopred

pfsomne schv6lila zmluvn6 vyskumnd

orgalrzdcia.

Pri preddasnom ukondenf zmluvy v srilade

s dast'ou 18.1.c bodom (2) z dOvodu

nedodrZania podmienok 20. dasti tejto

bez ohl'adu na ak6kol'vek kroky, ktor6

vykon6,uzawetdStridiou. ra

zodpovedn 6 za povinnosti vyplfv ajice z

tfchto zmhiv s tretfmi stranami.

imluvy bezodkladne vr6ti Sqtky materigly'

Termination of Study. If the Study is

terminated early, CRO will, except as

otherwise indicated in this subsection, pay

for work already performed, in accordance

with Attachment A, less payments already

made for such work. CRO will also cover

any non-cancelable expenses, other than

future personnel costs, so long as they were

properly incurred and prospectively

Institution for SUfI./EC fees and any other

expenses paid by Institution that were

prospectively approved, in writing, by CRO'

If the Agreement is terminated earlyfor non-Section 20 of.Institution

will be liable for damages or remedies as

provided by law and will not be entitled to

any further payment, regardless of any

activities undertaken by the Institution or

agreements with third Parties'

Return of Materials. Unless

CRO instructs otherwise in writing, upon

termination of the Agreement, Institutionreturn all materials suPPlied

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Page27 of 66

by CRO for Study conduct that are inInstitution's possession or control, includingunused Investigational Drug, unused CaseReport Forms, and any CRO-suppliedEquipment and Materials. Institution willalso cooperate with CRO, on request, tohelp ensure return of such materials in thepossession or control of PrincipalInvestigator

Survival of Obligations.Obligations relating to Funding,Confidential Information, Study Records,Inventions, Publications, Indemnifi cation,Suitability, and Anti-Bribery survivetermination of this Agreement, as does anyother provision in this Agreement, includingAttachments, that by its nature and intentremains valid after the term of theAgreement.

19. Other Terms

Suitabilit),. Institutioncertifies that it is suitable, as may be definedby local law, to act as a Study site andperform required Study-related activities.Institution also certifies that it is notdebarred under subsections 306(a) or (b) ofthe United States Federal Food, Drug, andCosmetic Act. During the term of thisAgreement and for three years after itstermination, Institution will notify CROpromptly if either of these certificationsneeds to be amended in lieht of newinformation.

Investi gations. Inquiries.

Institution

ktor6 vlastni alebo riadi a lro€ sriposkytnut6 zmluvnou vfskumnouorganiz{ciou na vykondvanie Sn'idie rrdranenepouZitych ski5anfch liekov, nepouZtfc-hformuldrov na hldsenie pripadova akdhokollvek vybavenia di materi6lovdodanfch zmluvnou vf skumnouorganizdciou. In5titricia tieZ poskynesridinno st' zmluvnej vy skumnej or ganzftciina jej poLiadanie a pom6Ze jej zabezpeEifvr6tenie tychto materi6lov, ktord vlastnia riadi hlavny skf5ajfci

Povinnosti tfkajfce sa financovania,dOvernfch informdcii, zdanamov Stridie,vynfllezov, publik6cif, od5kodnenia,sp6sobilosti a boja proti riplatkom, ako ajniektor6 d'alSie podmienky tejto zmluvyajej dodatkov, ktor6 svojim charakterom a

ridelom zostdvaji platn6 aj po skondenizmluvy, zostanf v platnosti aj po skondenfplatnosti tejto zmluvy.

Dal5ie podmienky

19.1 Sp6sobilosf. In5titriciapotvrdzuje, Le je v srilade s miestnymiprdvnymi predpismi sp6sobil6 byt'pracoviskom Stridie a vykondvaf potrebnddinnosti srivisiace so Stfdiou. In5titricia tieZpotvrdzuje, Le nemdnazfklade pod odsekov306 pfsm. (a) alebo (b) zdkonao potravin6ch, liekoch a kozmetickychpripravkoch USA zi{kaz vykon6vat' dinnost'.Podas trvania tejto zmluvy a po dobu trochrokov od jej ukondenia in5titricia budebezodkladne oznamovat' zmluvnejvliskumnej organizdcil ak tieto osveddeniabude potrebnd doplnit' alebo upravit' nazdkJade novli ch inform6cif .

Vv5etrovania. zisfovania.

v srivislosti s vvkon6vanfm vVskumu.

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of Excell€nce

In5titricia potvrdzuje, Le nieje a ani

v minulosti nebola predmetom vy5etrovania,

zist'ovania, upozornenia di donucovacieho

opatrenia St6tneho alebo reguladndho riradu

(spolu d'alej len ako ,,riradn6 konanie") v

srivislosti s vykon6van(m klinick6hovfskumu, o ktorom nebola zmluvn6

vf skumn6 or ganizdcia informov an6.

In5titticia okamZite oznfimi zmluvnej

vjskumnej organizdcii. Ze dostala

ozn6menie o fradnom konanf alebo sa stala

predmetom riradndho konania v srivislosti

s dodrZiavanim etickych, vedeckych alebo

reguladnych noriem vykondvania klinick6ho

vfskumu, ak sa toto riradn6 konanie tyka

udalostf alebo dinnost(, ku ktor'-im do5lo

podas obdobia vykon6vania Stddie alebo

pred n(m.

PouZivanie n6zvu a mena.

Zntlw nd vyskumn6 or ganizdcia a

spolodnost' Pfizet si vyhradzujri pr6vo

identifikovat' hlavndho skri5ajriceho a

in5titriciu v stivislosti s uveden(m protokolu

v datab6ae klinickfch skri5ani St6tneho

zdravotnfckeho riradu (NIH), v inichverejne pristupnf ch zoznamochprebiehajricich klinickfch skri5an( alebo

injch sluZb6ch alebo mechanizmoch n6boru

subj ektov Stridie. Zmltv nd vyskumn6

or ganizdcia ani spolodnost' Pfizer nebude

inak pouZivat ndzov in5titfcie ani men6

injch zamestnancov di doddvatel'ov

in5titricie, a ani inStitticia nebude pouZ(vat'

nfnov zmluvnej vyskumnej ot ganiz6cie,

spolodnosti Pfizet ani men6 ichzamestnancov di doddvatel'ov na propag6ciu

alebo reklamu bez pfsomn6ho srihlasu

zmluvnej strany, ktorej meno alebo n6zov sa

m6 pouZit'.

In5titricia je vo vzt'ahu k zmluvnejvyskumnej or ganizilcli nezdvi slymdod6vatel'om. Ich vzt'ah nie j

certifies that it is not the subject of any past

or pending governmental or regulatory

investigation, inquirY, warning, or

enforcement action (collectively, "Agency

Action") related to its conduct of clinicalresearch that has not been disclosed to

CRO. Institution will notify CRO promptly

if it receives notice of or becomes the

subject of any Agency Action regarding its

compliance with ethical, scientific, or

regulatory standards for the conduct ofclinical research if the Agency Actionrelates to events or activities that occurred

prior to or during the period in which the

Study was conducted.

Use of Name. CRO and

Pfizer reserve the right to identify the

Institution in association with a listing of the

Protocol in the United States National

Institutes of Health (NIH) Clinical TrialsData Bank, other publicly available listings

of ongoing clinical trials, or other Study

Subject recruitment services or mechanisms.

Neither CRO nor Pfizer will otherwise use

the name of Institution or anY ofInstifution's employees or conffactors, and

Institution will not use the name of CRO,

Pfrzer, or any of their respective employees

or contractors, for Promotional or

advertising purposes without writtenpermission from the party whose name willbe used.

Relationship of the Parties.

The relationship of Institution to CRO is one

of independent contractor and not one ofip, agent and PrinciPal, em

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and employer, joint venture, or otherwise vzt'ahom, vzt'ahom medzi z6stupcoma vedfcim, zamestnancoma zamestnilvatelom, spolodnym podnikom,ani inym podobnjm vzt'ahom.

19.5 Modification. Anvmodification to this Agreement must be inwriting, signed by the parties, and identifiedas an Amendment, except for certainmutually agreeable changes in the Studybudget as identified in Attachment A.

19.6 No Waiver. Failure to exerta right under this Agreement does notconstitute a waiver of that right in the future.No waiver of any right is effective unless inwriting and signed by the party who waivesthe right.

19.7 Conflict with Attachments.If there is any conflict between thisAgreement and any Attachments to it, theterms of this Agreement control. If there isany conflict between this Agreement and theProtocol, the Protocol will control as to anyissue regarding treatment of Study Subjects,and the Agreement will control as to allother issues.

19.8 Affiliates. As used in rhisAgreement, the term "affiliate" means anyentity that directly or indirectly controls, iscontrolled by, or is under common controlwith the named party.

19.9 Successors and Assigns.This Agreement will bind and inure to thebenefit of the successors and permittedassigns of each party.

19.10 Third Partv Beneficiary.Pfizer is an intended third

Zmeny . Ak6kol'vek zmenatejto zmluvy musf byt'pfsomn6, podpisandzmluvnymi stranami a vyhotovend formoudodatku. Vynimku tvoria niektord vziljomnedohodnutd zmeny rozpodtu Stridie uveden6v dodatku A.

19.6 NemoZnost' zrieknutia sapr6v. Neuplatnenie prdv a podta tejtozmluvy neznamend zrieknutie sa tohto pr6vav budfcnosti. Zrieknatie sa prdva nie jeplatnd, pokial'nie je uskutodnen6 pfsomnea podpfsand zmluvnou stranou, ktor6 sazrieka svojho pr6va.

19.7 Rozpor medzi zmluvou adodatkami. V pripade konfliktu medzi toutozmluvou a niektorym z jej dodatkov srirozhodujrice podmienky tejto zmluvy.V pripade konfliktu medzi touto zmluvoua protokolorn sa zilleZitosti tykajfcezaobchddzania so subjektmi Stridie iadiaprotokolom a vsetky ostatnd zilleiitostizmluvou.

19.5

19.8

19.9

Pobodky. Pojem,pobodka",ktory sa pouLivav tejto zmluve, oznadujesubjekt, ktorj priamo alebo nepriamo riadiuvedenri zmluvnf stranu, alebo je toutozmluvnou stranou riadeny, di podliehaspolodndmu riadeniu.

Prdvni n6stupcoviaa nadobridatelia. T6to zmluva bude zdvazn|a platnd pre pr6vnych n6stupcova povolenfch nadobridatel'ov obidvochzmluvnych str6n.

19.10 Oordvnen6 tretia osoba.benefi Zm7avn6, strany beni na vedomie a srih

Excellence

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Page 30 of 66

to ttris Agreement and is entitled to enforce

directly any and all of its rights under it.

19.11 Disclaimer of Warranties bY

CRO. THE PARTIES ACKNOWLEDGETHAT PFIZER HAS ENGAGED CRO TOPROVIDE SERVICES IN REGARD TOTHIS PFIZER-SPONSORED CLINICALSTUDY. CRO HAS NOT PERFORMED

ANY INDEPENDENT RESEARCH OR

ANALYSIS REGARDING THE SAFETYOR EFFICACY OF ANYINVESTIGATIONAL DRUG OR OTHERMATERIALS OR TREATMENTPROCEDURES TO BE USED IN THISSTUDY AND THEREFORE CRO MAKESNO WARRANTIES, EXPRESSED OR

IMPLIED, CONCERNING THOSEDRUGS. MATERIALS, OR TREATMENTPROCEDURES, THE RESULTS TO BEOBTAINED BY ADMINISTERINGTHEM PURSUANT TO THE PROTOCOL,

OR TO THEIR FITNESS FOR ANYPARTICULAR PURPOSE, OR TO ANYOTHER PFIZER OBLIGATION UNDERTHE PROTOCOL OR THISAGREEMENT.

19.12 Entire Agreement. This

Agreement, including Attachments,represents the entire understanding between

the parties relating to this subject matter'This Agreement supersedes all previous

agreements between the parties (oral and

written) relating to this Study, except forany obligations that, by their terms, survive

independent of this

Ze spolodnost' Pfizer je urdenou oprdvnenou

tret'ou osobou podla tejto zmluvy a md

ndrok priamo uplatflovat' ktordkol'vek zo

svojich pr6v uvedenfch v tejto zmluve.

Zrieknutie sa zi{ruk19.11

zmluvnou vyskumnou or ganiz6ciou.

ZMLUVNE STRANY POTVRDZUJU, ZE

SPOLOCNOST PFIZER POVERILAZMLUVNU VYSTUUMJORGANZACIU POSKYTOVANIMSLUZIEB V SUVSLOSTI S TOUTOKLINICKOU STUOTOU, KTOREJZADAVATELOM JE SPOLOCNOSTPFIZER. ZMLUVNA VYSTUITANAORGANZACN NEVYKONALAZrepBN NEZAvISLf vYsruM ANIANALfZU TYTEruCU SABEZPEdNOSTI ALEBO UCINNOSTTsTUSENEHO LIEKU ANI INYCHMATERIALOV iI LIECEBNfCHPROCEDUR. KTORE SA MAJU POUZfiV TEJTO STUOU A PRETONEPOSKYTUJE ZIADNE VYSLOVNB iTVYPLfVATUCE ZARUKY TYTETUCBSA TfCHTO LIEKOV, MATERIALOVALEBO LIEdEBNYCH PROCEDUR,VYSLEDKOV. KTORE SA MAJUDOSIAHNUf ICU PODAVANIU VSUMOB S PROTOKOLOM, ANI ICHVHODNOSTI NA AKYKOLVEKKONKRETNY TJdBI-, CT INYCTT

POVINNOSTi SPOIOCNOSN PFIZERVYPLfVAJUCICH Z PROTOKOLUALEBO TEJTO ZMLUVY.

lg.l2 Uplnost'zmluvy. T6to

zmluva vrdtane jej dodatkov predstavuje

ripln6 znenie dohody medzi zmluvnymistranami v srivislosti s predmetom zmluvy.T6to zmluv a nahr 6dza v SetkY

pr edchldzajrice dohody zmluvnich str6n

(ristne aj pisomn6) tfkajrice sa tejto Stfdie

s vfnimkou povinnosti, ktor6 podl'a ichmienok pretrv6va iri nezdvisle od tei

Page 31 of66

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A Symbol of Excellence

A Svmbol of Excellence

19.r3 Language. This Agreementis set forth in both Slovak and English, withboth versions having the same effect. In theevent of any ambiguity or conflicts ininterpretation of terms between the twoversions, the English version will prevail.

19.14 Notices. The parties willdeliver notices and other communicationsrelating to this Agreement by hand, bycourier, or by a postage-paid traceablemethod of mail delivery to the mailingaddress below. or such other address that aparty may later designate by notice to theother party in accordance with this Section.

CRO:ICON Clinical Research s.r.o.V Parku 2335/20148 00 Praha 4 - Chodov, Czech Republic

Attention: Vladimfr KotalaTelephone: +420555130590E-mail : Vladimir.Kotala @iconplc.com

zmluvy.

19.13 Jazvk. T6to zmluva budevyhotovend v slovenskom a v anglickomjazyku, pridom obidve jazykovd verzie majl(u

rovnakri platnost'. V pripade nejasnostialebo rozporov vo vliklade pojmov medzitfmito dvomi verziamt bude rozhodujricaanglick6 verzia.

19.14 Oznamv. Zmlavnd stranydorudia oznamy a inri komunik6ciu tykajricusa tejto zmluvy osobne, prostrednictvomkuri6ra alebo doporudenej po5ty na uvedenfadresu alebo inf adresu, ktoni nesk6rniektor6 zo zmluvn'ich strdn ozn6mi druhejstrane v srilade s touto dast'ou.

Zmlav nd vf skumn6 or ganizdcia:ICON Clinical Research s.r.o.V Parku 2335/20148 00 Praha 4 - Chodov, eesk6 republikaNa vedomie: Vladimir KotalaTelef6n : +420 5 5 5 130 59 0E-mail : Vladimir.Kotala @ iconplc.com

Institution:

Liptovskd nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikul65Attention: Mgr. Zuzana Gregorov6

Telephone: :+421 44 55 63 502

Email:

InStitricia:

Liptovskd nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovsky Mikul65Na vedomie: Mgr. Zazana Gregorov6

Telef6n:+421 44 55 63 502

E-mail:

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Page32 of 66

Wizer:.

Len na ridely predkladania publik6cif:

James H. Revkin, MDSenior DirectorPfrzer Inc., Primary Care Business Unit

Clinical Sciences GrouP

M.58260-2277445 Eastern Point Road

Groton, CT 06340

USAJames.revkins @ Pfi zer'com

Pfrzer:

For Submission of Publications Only:

James H. Revkin, MDSenior DirectorPfizer Inc., Primary Care Business Unit

Clinical Sciences GrouP

M.58260-2277445 Eastern Point Road

Groton, CT 06340

USAJames.revkins @Pfi zer'com

SWP-CSA 3(a)-Institution-Slovakia

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Page 33 of 66

A bol of Excellence20. Anti-Bribery

The parties acknowledge that CRO andPfizer are bound by all applicable anti-comrption and anti-bribery laws andregulations including but not limited toForeign Corrupt Practices Act (FCPA) andUK Bribery Act and will not cause CRO orPfizer to be in breach of theirresponsibilities through any act as describedin this section.

In performing the Study and/or servicesunder this Agreement, the non-CROcontracting party / parties (and theiremployees and agents) (i) agree(s) that it hasnot and shall not, directly or indirectly, offerto make, promise, authorize or accept anypayment or anything of value, includingbribes, gifts and/or donations to or from anypublic official, regulatory authority oranyone else for the improper purpose ofinfluencing, inducing or rewarding any act,omission or decision in order to secure animproper advantage, including to obtain orretain business; and (ii) shall comply withall applicable anti-comrption and anti-bribery laws and regulations. The non-CROcontracting pntylparties shall notify CROand Pfizer immediately upon becomingaware of any breach under this section.

20. Boi proti fplatkom

Zmluvn1 strany beni na vedomie, Zezmluv nd vyskumn6 or ganizlciaa spolodnosf Wizer sf zaviazand v5etkymiplatnymi pr6vnymi predpismia nariadeniami na boj proti korupciia fplatkom, najmzi Zdkonom o zahranidnfchkorupdnych praktik6ch (dalej len ako zdkon,,FCPA") a zdkonom Spojendho krdl'ovstvao boji proti riplatkom, a nespdsobia, abydo5lo k poruSeniu akychkol'vek pr6vnychpredpisov uvedenfch v tejto dasti zmluvnouvyskumnou or ganizlciou alebospolodnost'ou Pfizer.

Pri vykon6van( Stridie alebo poskytovanisluZieb podl'a tejto zmluvy zmhtvn| stranaalebo zmluvnd strany, ktord nie srizmluvnou vfskumnou organizdciou (a ichzamestnanci a z6stupcovia) (i) sazvdzlji,Lepiamo ani nepriamo neponrikli anineponriknu, nesl'fbia ani neschv6lia Ziadnuplatbu ani hodnotni vec vrdtane fplatkov,darov alebo dot6cif, verejndmu fradnfkovi,reguladndmu riradu ani inej osobe, ani ichod tychto os6b neprijmf na nevhodny ridelovplyvnenia dinu, podnietenia k dinu aleboodmeny za Ein, nekonanie alebo rozhodnuties ciellom zabezpelif neprimeranri vfhoduvrdtane zfskania alebo udrZania si obchodneiprileZitosti; a (ii) budri konat'v srilades prfslu5nymi prdvnymi predpismi na bojproti korupcii a riplatkom. Zmluvnd strana

For the purpose of ensuring compliancewith applicable anti-bribery laws andregulations, non-CRO contractin

alebo zmluvn6 strany, ktord nie sfzmluvnou vliskumnou or ganizdciou, buddbezodkladne informovat' zmluvnrivyskumnri organizdciu a spolodnosf Pfrzer,ak sa dozvedia o akomkol'vek poruSenipodl'a tejto dasti.

Na fdely zabezpelenia dodrZiavania sriladus prislu5nymi prdvnymi predpismia nariadeniami na boi proti ri

SWP_CSA 3(a)_Institution_Slovakia0l September 2013B 1481038- Liptovskd nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskf Mikul65_site 2172_Kycina

Page 34 of66

partylparties agree(s) that CRO shall have zmluvnd strana alebo zmluvn6 strany, ktor6

the right to conduct an investigation or audit

of the non-CRO contracting partylparties

during the term of this Agreement to

monitor compliance with the terms of this

section. The non-CRO contractingpartylparties shall cooperate fully with such

investigation or audit, the timing of whichshall be at the sole discretion of CRO.

nie sri zmluvnou vyskumnou organizdciott,

sa zv dzuji, Le zmluv n6 vY skumnd

or ganiz6cia bude oprdvnen6 vykon6v at'

vjskum alebo audit v zmluvnej strane alebo

zmluvnlich stran6ch, ktor6 nie sti zmluvou

vf skumnou or ganiz6ciou, podas platno sti

tejto zmluvy a sledovat' dodrZiavaniepodmienok tejto dasti. Zmbtvnd strana alebo

zmluvn6 stran]; ktor6 nie sd zmluvnouvjskumnou orgatizdciou, budti v plnej

miere poskytovat' sridinnost' pri takomto

vy5etrovanf alebo audite, ktord budri

nadasovan6 na zilklade vYludn6ho

rozhodnutia zmluvnej viskumnejorganizdcie.

Page 35 of66

SWP-CSA 3(a)-Institution-Slovakia0l September 2013St+aiOlg_ Liptovsk6 nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskf Mikul65-site 2172-Kycina

of Exc.ellence

Agreed to and Accepted by:

Liptovsk6 nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikul65

Osoby opr6vnend podpisat' trito zmluvu:

Liptovskd nemocnica s poliklinikouMUDr.Ivana Stodolu Liptovskf Mikutds

Ing.IJud

Title: D

Date:

Ing.IJudmila Po

Funkcia: riadit

D6tum: :3

ICON Clinical Research Limited

--rovakia

-vskd nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovskll Mikul{s_site 2172_Kycina

tB,

ICON Clinical Research Limited

Paee 36 of66