NON-INTERVENTIONAL STUDY RESEARCHAGREEMENTexecuted in compliance with Section 269. par. 2 of Act

ZMLUVA ONEINTERVENCNOM KLINICKOMSKUSANIuzatvorena podia $ 269 ods. 2 zak. c. 513/1991 Zb.

No. 513/1991 Coll.. Commercial Code, in the wording oflater regulations

I. PARTIES:

A/ Univerzitna nemocnica L. Pasteura KosiceRegistered Address: Rastislavova 43, 041 90 Kosice,Slovenska republika (the Slovak Republic)Represented by: MUDr. Iveta Marinova - DirectorIdentification No. (ICO): 00 606 707Tax Id. No. (ICDPH): SK2021141969Bank: Statna pokladnica,

Account No.: 7000280550/8180IRAN : SK06 8180 0000 0070 0028 0550BIG : SUBASKBXSpecific Symbol = Protocol No.Variable Symbol (Payment id. No.) = Invoice No.A Semi-Budgetary Organization established by the Deedof Incorporation of the Ministry of Health of the SR No.1842/1990 - A/I - 2 dated December 18,1990,(further only "Institution")

and

B/ Schering-Plough, s.r.o.Address: Strakova 5, 811 01 Bratislava, Slovenskarepublika (the Slovak Republic),Represented by: Peter Musil, M.D. - Managing DirectorIdentification No. (ICO): 44393326,Tax Id. No. (ICDPH): SK2022688272Bank and Account No.:Entered in the Commercial Register of the District CourtBratislava I, Section: Sro, Insert No. 54614/Bas the authorized representative of the Sponsor(further only "Schering")

collectively the "Parties"

II. OBJECT OF AGREEMENT

1. The clinical trial sponsor - Schering-Plough Central

East AG, Weystrasse 20, 6000 Lucerne 6, Switzerland,

(further only "Sponsor") is willing to perform, in co-

operation with the Institution, a non-interventional clinical

study named "Observational project on the current

Obchodny zakonnik. v zneni neskorsich predpisov

I. ZMLUVNE STRANY :

A/ Univerzitna nemocnica L. Pasteura Kosiceso sidlom : Rastislavova 43, 041 90 Kosice,Slovenska republikav zastupeni: MUDr. Iveta Marinova - riaditel'ICO : 00 606 707ICDPH :SK2021141969Bankove spojenie : Statna pokladnica,

c.u. 7000280550/8180IBAN : SK06 8180 0000 0070 0028 0550BIC : SUBASKBXspecificky symbol - cislo protokoluvariabilny symbol = cislo fakturyStatna prispevkova organizacia zriadenaZriad'ovacou listinou MZ SR c. 1842/1990 - A/I - 2zodna 18.12.1990(d'alej len "Institucia")

B/ Schering-Plough, s.r.o.so sidlom Strakova 5, 811 01 Bratislava, Slovenskarepublika,v zastupeni: MUDr. Peter Musil - konatel'ICO: 44393326,1C DPH:SK 2022688272Bankove spojenie :Zapisany v Obchodnom registri Okresneho suduBratislava I, odd. : Sro, vlozka c. 54614/Bako splnomocneny zastupca zadavatef a(d'alej len ,,Schering")

d'alej spolu ako ,,zmluvne strany"

II. PREDMET ZMLUVY

1. ZadavateF klinickeho skusania - Schering-Plough Central East AG, Weystrasse 20,6000 Lucerne 6, Svajciarsko (d'alej len,,Zadavater') ma zaujem vykonafv spolupraci s Instituciou neintervencneklinicke skusanie snazvom ,,Pozorovaci

neuromuscular monitoringpractice (including extubation practice) via TOF-ratio

measurements in different types of surgery afteradministration of neuromuscular blocking agentswith or without reversal" (further only the "Study")according to Protocol No. P06556 (further only the"Protocol").

2. The Institution and the Investigator shall conduct theStudy to be performed under this Agreement inaccordance with the terms of this Agreement andthe Protocol, as amended in accordance with theterms of this Agreement.

3. The Institution shall conduct the Study at its site ledby principal investigator:

I.Klinika anesteziologie a intenzivnej mediciny,pracovisko Trieda SNP 1, Kosice, SlovakRepublic, under the leading of the Investigator,Doc. MUDr. Jozef Firment, PhD., who isemployee of the Institution. The clinical trialwill be conduct by the Investigator incooperation with MUDr. Blanka Kalnasova,MUDr. Tomas Sefara, MUDr. Peter Firment,MUDr. Zuzana Liptakova, MUDr. ZanetaHutnanova, who are employees of theInstitution (further principal Investigator and allSub-Investigators only "Investigator" )

4. The Protocol may be amended or revised from timeto time by Sponsor. Schering will inform theInstitution in writing about the proposedamendment of the Protocol. The amendment of theProtocol shall be object of amendment of thisAgreement to be executed by the Parties based ontheir mutual agreement.

5. The Institution declares thata/ The Institution and its employees are adequate to

perform the Study contemplated by this Agreementand the Protocol;

b/ All aspects of the Study will be conducted inconformity with all applicable laws, in particularwith Act No. 140/1998 Coll. as amended and ActNo. 576/2004 Coll. as amended, with theregulations, codes of conduct, guidance andregulatory requirements, including applicablepersonal data protection laws, in particular Act No.428/2002 Coll. as amended, and, to the extentrelevant, the guidance relating to the conduct of

projekt tykajuci sa sucasnej praxemonitorovania nervovosvalovej blokady(vratane extubacie) na zaklade meranipomeru TOF (train-of-four) pri rozlicnychdruhoch chirurgickych zakrokov po podaninervovosvalovych blokatorov so zvratenimich ucinku alebo bez neho" (d'alej len,,Klinicke skusanie") podl'a protokoluP06556 (d'alej len ,,Protokol").

2. Institucia a Skusajuci vykonaju Klinickeskusanie, ktore sa ma vykonat' na zakladetejto Zmluvy v sulade s ustanoveniami tejtoZmluvy a Protokolu, vratane jeho zmienuskutocnenych v sulade s ustanoveniamitejto Zmluvy.

3. Klinicke skusanie Institucia uskutocni nasvojom pracovisku pod vedenim hlavnehoskusajuceho:I. Klinika anesteziologie a intenzivnejmediciny, pracovisko Trieda SNP 1, Kosicepod vedenim skusajuceho Doc. MUDr.Jozef Firment, PhD., ktory jezamestnancom Institucie. Klinickeskusanie vykona skusajuci v spolupraci sMUDr. Blanka Kalnasova, MUDr. TomasSefara, MUDr. Peter Firment, MUDr.Zuzana Liptakova, MUDr. ZanetaHutnanova, ktori su zamestnancamiInstitucie (hlavny skusajuci a vsetcispoluskiisajuci oznaceni len ako"Skusajuci");

4. Zadavatel' moze Protokol podfa potrebydoplnaf alebo revidovaf. Schering budepisomne informovaf Instituciuo navrhovanom dodatku Protokolu.Dodatok k Protokolu bude predmetomdodatku k tejto zmluve, ktory zmluvnestrany uzatvoria po vzajomnej dohode.

5. Institucia prehlasuje, zea/ Institucia a jej zamestnanci su riadnesposobili na vykon Klinickeho skusaniapodl'a tejto Zraluvy a Protokolu;b/ vsetky aspekty Klinickeho skusaniabudu vykonavane v sulade so vsetkymiplatnymi pravnymi predpismi, najma vsakzak. c. 140/1998 Z.z. vzneni neskorsichpredpisov a zak. c. 576/2004 Z. z. v znenineskorsich predpisov, nariadeniami,etickymi kodexmi, usmerneniamia regulacnymi poziadavkami, vratane

Post-Authorisation Safety Studies ("PASS")contained in Volume 9 of the EuropeanCommission's Rules Governing Medicinal Productsin the European Union (further in the whole textonly the "Applicable Law").

6. The Institution and Investigator each represent andwarrant that the activities carried out in the Studyshall in no way influence the course of treatmentrecommended or implemented for the subjects inthe Study.

III. INVESTIGATOR

1. The Investigator will be responsible for theperformance of the direction and supervision of allStudy efforts in accordance with Applicable Law,relevant Institution policies, the Protocol and thisAgreement.

2. In the event of a change in the person of theInvestigator, due to the termination of hisemployment in the Institution the Institution shall,within ten (10) days of such termination ofemployment of the Investigator, provide writtennotice of such event to Schering and propose asuccessor of the Investigator, who is employee ofthe Institution.

3.. Any successor to the Investigator must be approved,in writing, by Schering and such successor shall berequired to agree to all the terms and conditions ofthe Protocol and this Agreement and to sign eachsuch document as evidence of such agreement(although failure to so sign will not relieve suchsuccessor from abiding by all the terms andconditions of the Protocol and this Agreement).

4. The Investigator is remunerated for the performanceof the tasks and obligations under this Agreementexclusively by the Institution and Schering has nofinancial obligations towards the Investigator orhis/her successor as described above.

6.

platnych pravnych predpisov o ochraneosobnych udajov, najma vsak zak. c.428/2002 Z. z. v zneni neskorsich predpisova, vrelevantnom rozsahu, usmernenitykajucich sa vykonavaniapostregistracnych studii bezpecnosti(,,PASS") obsiahnutych vo zvazku 9Pravidiel Europskej Komisie pre lieky v ES(d'alej celytextlen ,,Platne pravo").

Institucia a Skusajuci vyhlasuju a rucia, zecinnosti vykonavane pri Klinickom skusaniziadnym sposobom neovplyvnia priebehliecby odponicany alebo uskutocneny preucastmkov Klinickeho skusania.

III. SKUSAJUCI

Skusajuci bude zodpovedny zavykonanie, riadenie adohl'ad nadvsetkymi cinnost'ami v suvislostis Klinickym skusanim v sulade s Platnympravom, prislusnymi predpismiInstitucie, Protokolom a touto Zmluvou.V pripade, ak dojde k zmene v osobeSkusajuceho z dovodu skoncenia jehopracovneho pomeru v Institucn,Institucia do desiatich (10) dni odo dnaskoncenia pracovneho pomeruSkusajuceho predlozi spolocnostiSchering oznamenie o uvedenoma navrhne nastupcu skusajuceho, ktory jezamestnancom Institucie.Schering musi pisomne schvalit'akehokol'vek nastupcu Skusajuceho a odtakeho nastupcu sa bude pozadovat', abysiihlasil so vsetkymi ustanoveniamiProtokolu a tejto Zmluvy, a aby na dokaztakeho svihlasu podpisal kazdy takytodokument (aj ked' nepodpisanie takychdokumentov nezbavi takeho nastupcupovinnosti dodrziavat' vsetkyustanovenia Protokolu a tejto Zmluvy).Skusajuceho odmenuje za plnenie uloha povinnosti podl'a tejto Zmluvy vylucneInstitucia a Schering nema ziadnefinancne zavazky voci Skusajucemualebo jeho/jej nastupcovi, ako je uvedenevyssie.

IV. STUDY MONITOR AND INSPECTIONRIGHTS

1. The Parties agreed that study monitor(s) and othersdesignated by Schering ("Study Monitor") who provetheir identity by a regular authorization issued by theSponsor or Schering may, at mutually agreeable timesduring the Study and for a reasonable time aftercompletion or early termination of the Study, arrangewith the Investigator or his/her designee:

(i) to examine and inspect, at regularbusiness hours, the Institution facilitiesrequired for performance of the Study;and

ii) subj ect to applicable patientconfidentiality and data protectionconsiderations, to inspect, audit, and tocopy or have copied, all data and workproduct relating to the Study conductedunder this Agreement and to inspect andmake copies of all data necessary forSchering and/or the Sponsor to confirmthat the Study is being conducted inconformance with the Protocol and incompliance with all applicable legal andregulatory requirements.

2. The Institution agrees to assist to a reasonable extentSchering and/or the Sponsor and the Study Monitor, tothe extent deemed reasonable to facilitate any suchinspection, auditing and copying activities relating tothe Study and in order to enforce the rights granted toSchering and/or the Sponsor and the Study Monitoraccording to this Article.

V. ETHICS COMMITTEE APPROVALS

1. Schering shall be responsible for obtaining the

IV. OSOBY URCENE NA MONITOROVANIEKLINICKEHO SKUSANIA A PRAVO NAKONTROLU

1. Zmluvne strany sa dohodli, ze osoby urcene namonitorovanie Klinickeho skusania a ine osobyurcene spolocnost'ou Schering (,,Osoby urcene namonitorovanie Klinickeho skusania"), ktore sapreukazu riadnym poverenim Zadavatel'a alebospolocnosti Schering,, su opravnene vo vzajomneodsuhlasenom case pocas Klinickeho skusaniaapocas primeraneho obdobia po ukonceni alebopredcasnom ukonceni Klinickeho skusaniadohodnut' so Skusajucim alebo jeho/jej zastupcom:

(i) preskumanie a kontrolu, pocasriadnych pracovnych hodin, zariadeniInstitucie potrebnych na vykonKlinickeho skusania; a

ii) podliehajuc platnym ustanoveniamo ochrane osobnych udajov ucastnika,kontrolu, audit a skopirovanievsetkych udajov aproduktu pracesuvisiacich s Klinickym skusanimvykonavanym podl'a tejto Zmluvy a zaucelom kontroly a kopirovaniavsetkych udajov potrebnych na to, abySchering a/alebo Zadavatel' moholpotvrdit', ze Klinicke skusanie savykonava v sulade s Protokoloma v sulade so vsetkymi plamymipravnymi a regulacnymipoziadavkami.

2. Institucia suhlasi s tym, ze poskytne primeranusucinnost' spolocnosti Schering a/alebo Zadavatel'ovia Osobe urcenej na monitorovanie Klinickehoskusania, v rozsahu primeranom za ucelomul'ahcenia akychkol'vek cinnosti tykajucich sakontroly, auditu a kopirovania suvisiacichs Klinickym skusanim a za ucelom vykonu pravudelenych spolocnosti Schering a/aleboZadavaterovi a Osobe urcenej na monitorovanieKlinickeho skusania. podl'a tohto clanku.

V. SCHVALENIA ETICKEJ KOMISIE

1. Schering zodpoveda za ziskanie nasledovneho:

following:

(i) to the extent that it is required,approval of the Protocol and anypatient information and informedconsent documentation relating tothe Study and advertisement, ifany, pertaining to the enrolmentof subjects in the Study by theappropriate Ethics Committeeprior to beginning any Study onhuman subjects; and

(ii) the written informed consent of thesubject's participating in the Study.

2. In the event that Ethics Committee approval isnecessary and the Ethics Committee requires changes inthe Protocol or any patient information and informedconsent documentation, Schering shall be advised inadvance and all modifications to the Protocol or anypatient information and informed consent documentationmust be approved in advance by Schering. TheInstitution and Investigator shall not modify or deviatefrom the Protocol or modify any patient information andinformed consent documentation once finalized andapproved by the Ethics Committee without the priorwritten approval of Schering.

VI. TERM OF AGREEMENT

1. The Agreement shall be executed for a definite periodof time from the effective day till July 31,2012.

2. For the case that the Study is not regularly completedat the expiry of the period of effectiveness of theAgreement according to point 1. of this Article, theParties agree to execute an Amendment to theAgreement with the extension of the time of validityof the Agreement for the period necessary tocomplete regularly the Study, proposed bySchering, as object of Amendment.

(i) v pozadovanom rozsahu,schvalenia Protokolua akychkol'vek udajovo ucastnikoch a dokumentochs informovanym suhlasomsuvisiacich s Klinickymskusanim, a inzercie, akexistuje, tykajucej sa naboruucastnikov do Klinickehoskusania, zo strany prislusnejEtickej komisie predzaciatkom akehokol'vekKlinickeho skusania naucastnikoch; a

(ii) vyhotovenia pisomnehoinformovaneho suhlasuurceneho pre ucastnikaKlinickeho skusania.

2. V pripade, ze schvalenie Etickej komisie jepotrebne aEticka komisia vyzaduje zmenyv Protokole alebo akychkol'vek udajoch o ucastnikocha dokumentoch s informovanym suhlasom., Scherings tym bude vopred oboznameny a vsetky zmenyv Protokole alebo akychkol'vek udajocho ucastnikoch a dokumentoch s informovanymsuhlasom budu musief byf vopred schvalenespolocnost'ou Schering. Institucia ani Skusajucinezmenia ani sa neodchylia od Protokolu, aninezmenia ziadne udaje o ucastnikovi a dokumenrys informovanym suhlasom po ich finalizaciia schvaleni Etickou komisiou bez predchadzajucehopisomneho suhlasu spolocnosti Schering.

VI. DOBA PLATNOSTIZMLUVY

1. Tato zmluva sa uzatvara na dobu urcitu ododna ucinnosti do 31. Jula 2012.

2. V pripade, ze klinicke skiisanie nebuderiadne ukoncene do uplynutia doby platnostitejto zmluvy podl'a bodu 1. tohto clanku,zmluvne strany sa dohodli, ze uzatvoriadodatok k tejto zmluve, ktoreho predmetombude predlzenie platnosti tejto zmluvy na caspotrebny na riadne ukoncenie klinickehoskusania, ktory navrhne Schering.

VII. TERMINATION AND ENROLMENT CAP

1. Any of the Parties shall be entitled to terminate thisAgreement by notice without giving the cause. Thenotice period makes thirty (30) calendar days and startsthe first day of the notice delivery to the other Party.

2. The Parties shall be entitled to withdraw from theAgreement in the event that:a/ the termination of the Study is necessary due to theevaluation of risks to enrolled research subjects;b/ one of the Parties fails to comply with the Agreementand the failure is not remedied within 30 calendar daysfrom the day when the Party obtained the call to remedythe breach from the other Party.

3. Schering shall be entitled to withdraw from thisAgreement for any Material Breach which shall bedefined as:

(i) any failure by the Institution orInvestigator to comply with theirobligations or responsibilitiesunder this Agreement, theProtocol or Applicable Law; and

(ii) any failure by the Institution orInvestigator to comply with theirobligations to notify Scheringunder this Agreement, the Protocolor Applicable Law;

(iii) notification from the Institution orfrom the Investigator that theStudy will not be commenced orcompleted as scheduled in theProtocol.

4. The withdrawal is effective as at the date of delivery ofwritten notice of withdrawal to the other Party at theregistered address of the Party specified in Art. I of theAgreement. To avoid the doubts, the Parties agree that thenotice of withdrawal shall be deemed delivered on thefifth day from the day of its due mailing and the day ofmailing shall not be included in the agreed period of time.

VII. UKONCENIE ZMLUVY A OBMEDZENIENABORU UCASTNIKOV

1. Kazda zo zmluvnych stran je opravnenaukoncit'platnost' tejto zmluvy a to vypoved'ou bezuvedenia dovodu. Vypovedna lehota je tridsaf (30)kalendarnych dni a zacina plynuf prvym dnomnasledujucim po doruceni vypovede druhejzmluvnej strane.

2. Zmluvne strany su opravnene od tejto zmluvyodstiipit' v pripade, zea/ ukoncenie klinickeho skiisania je potrebnevzhTadom na zhodnotenie rizik hroziacimprihlasenym skumanym ucastnikom;b/ dochadza kporusovaniu tejto zmluvy a nedoslok naprave v plneni tejto zmluvy a to ani v lehote 30kalendarnych dni odo dna kedy zmluvna stranaobdrzala pisomnu vyzvu druhej zmluvnej strany nanapravu v plneni.

3. Schering je opravneny odstiipit' od tejto zmluvyz dovodu Zavazneho porusenia, ktore je definovaneako:

(i) akekol'vek nedodrzaniezavazkov alebo povinnostipodl'a tejto Zmluvy,Protokolu alebo Platnehoprava zo strany Instituciealebo Skusajuceho; a

(ii) akekol'vek nedodrzaniepovinnosti upovedomifSchering podl'a tejto Zmluvy,Protokolu alebo Platnehoprava zo strany Instituciealebo Skusajuceho;

(iii) oznamenie Institucie aleboSkusajuceho, ze Klinickeskusanie nebude zahajenealebo ukoncene podl'a planuv Protokole.

4. Odsuipenie je ucinne dnom dorucenia pisomnehooznamenia o odsnipeni od zmluvy druhej zmluvnejstrane na adresu sidla zmluvnej strany uvedenu v 51.1.tejto zmluvy. V pripade pochybnosti, sa zmluvnestrany dohodli, ze oznamenie o odstupem od zmluvy

5. In the event of termination of the Agreement prior tothe expiry of the term according to Article VI. point 1 ofthe Agreement:

(i) the Institution and Investigatorshall return to Schering allunused materials, including butnot limited to, materials suppliedfor the purpose of the Study;

(ii) the Institution and Investigatorshall return to Schering all Studydata and records created orcollected prior to the point ofStudy termination in accordancewith this Agreement, the Protocoland Applicable Law, the duties inthe area of keeping health recordsshall not be affected;

(iii) except in the event of terminationbecause of a Material Breach bythe Institution, and unlessotherwise specified in writingbetween the parties, the total sumspayable by Schering pursuant tothis Agreement shall be equitablypro-rated for actual workperformed in accordance with theProtocol to the date of terminationof the Agreement with anyunexpended portion of fundspreviously paid by Schering to theInstitution being refunded toSchering;

(iv) except in the event of terminationas a result of a Material Breach,the parties agree to make a goodfaith effort to reach agreement tocompensate the Institution foractual work performed inaccordance with the Protocol tothe date of termination of theAgreement;

(v) The Investigator shall return toSchering all Confidential

sa povazuje za dorucene na 5. den odo dna jehoriadneho odoslania postou, pricom den odoslania sado tejto lehoty nepocita.

5. Vpripade ukoncenia platnosti zmluvy, preduplynutim doby podl'a cl.VI. bod 1 tejto zmluvy :

(i) Institucia a Skusajuci vratiaspolocnosti Schering vsetkynepouzite materialy, vratane,nie vsak vylucne, materialovdodanych na ucelyKlinickeho skusania;

(ii) Institucia a Skusajuci vratiaspolocnosti Schering vsetkyudaje azaznamy tykajuce saKlinickeho skusaniavytvorene alebo zhromazdenepred ukoncenim Klinickehoskusania v siilade s toutoZmluvou, Protokoloma Platnym pravom, tymto niesu dotknute povinnostiv oblasti uchovavaniazdravotnej dokumentacie;

(iii) okrem pripadu ukonceniaZmluvy z dovodu Zavaznehoporusenia zo strany Institucie,a pokial' sa medzi stranamipi'somne nedohodlo inak,celkove sumy splatne zo stranyspolocnosti Schering v zmysletejto Zmluvy budu spravodlivopomeme rozdelene zaskutocne vykonanu pracuv sulade s Protokolom do dnaukoncenia platnosti zmluvys tym, ze akakoFveknevynalozena casf financnychprostriedkov vyplatenychspolocnosfou ScheringInstitiicii bude spolocnostiSchering vratena spaf;

(iv) okrem pripadu ukonceniaZmluvy nasledkom Zavaznehoporusenia, strany sa dohodli,ze sa v dobrej viere vynasnazia

Information (as defined in Article10 below) owned or controlled bySchering and in the possession ofthe Institution.

6. The termination of this Agreement shall notrelieve either Party of its obligation tothe other in respect of:

(i) retaining in confidence allConfidential Information (asdefined in Article XI. below);

(ii) complying with record keepingand reporting obligations (underArticle VIE. below);

(iii) obtaining written approval andconsents for any publications(under Article XII. below) andpublicity and promotionalpurposes (under Article XIX.below);

(iv) compensation for servicesperformed to date of notice oftermination, except as set forth inArticle 5 (iii) above;

(v) indemnification and insuranceobligations (under Article XIII.below);

(vi) inspection rights (under Article IV.above); and

(vii) obligation to assist in obtainingpatent protection (under ArticleXIV. below).

dosiahnut' dohodu za ucelomnahrady skutocne vykonanejprace pre Instituciu v sulades Protokolom do dnaukoncenia platnosti zmluvy;

(v) Skusajuci vrati spolocnostiSchering vsetky Doverneinformacie (ako je uvedenev 61. XI. nizsie), ktore Scheringvlastni alebo kontroluje asu vdrzbe Institucie.

6. Ukoncenie platnosti tejto Zmluvy nezbavujeziadnu stranu jej povinnosti voci druhej straneohTadom:

(i) zachovania mlcanlivostio vsetkych Dovernychinformaciach (ako je uvedenev 61. XI. nizsie);

(ii) dodrzania siiladu v oblastivedenia dokumentaciea ohlasovacej povinnosti(podl'a cl. VIII. nizsie);

(iii) ziskania pisomneho schvaleniaa suhlasov na akekolVekzverejnenia (podfa 61. XII.nizsie) ana ucely propagacieareklamy (podl'a 61. XIXnizsie);

(iv) kompenzacie za sluzbyposkytnute pred dnomukoncenia Zmluvy, okrempripadu uvedeneho v bode 5(iii) vyssie;

(v) povinnosti nahrady skody apoistenia (podl'a 61. XIII.nizsie);

(vi) prava na kontrolu (podl'a cl. IVvyssie); a

(vii) povinnosti poskytnufsucinnost' pri ziskanipatentovej ochrany (podl'a 61.

d'-

All of the foregoing obligations are binding on theappropriate Party and shall remain in full force andeffect as set forth in this Agreement.

7. The Institution will not enrol more than five patientsin the Study without presious approval of Schering.Further patients shall be enroled only with previousapproval of Schering. Schering reserves the right tolimit enrolment by giving written notice, or by givingnotice by telephone followed by written notice, to theInstitution and Investigator to cease further enrolment inthe Study ("Enrolment Cap"). Upon receipt of suchwritten notice, the Institution and Investigator agree toenrol no further patients in the Study. Unless otherwisespecified in writing between the Parties, in the event ofsuch a notice to cease further enrolment, the total sumspayable by Schering pursuant to this Agreement shall beequitably pro-rated for the number of patients enrolledto the date of such notice, with any funds for patientsbeyond the Enrolment Cap previously paid by Scheringto the Institution being refunded to Schering.

VIII. RECORDS AND REPORTS

1. The Investigator and Institution shall have thefollowing record keeping and reporting obligations:

(i) preparation and maintenance ofcomplete, accurately writtenrecords, accounts, notes, reportsand data relating to the Studyunder this Agreement; and

(ii) preparation and submission toSchering (in a periodic and timelymanner during the term of thisAgreement) of all raw data andother material called for in theProtocol in the form of properlycompleted patient case reportforms ("Case Report Forms" or"CRF's") or into an electronicdatabase (i.e., remote data entry)supplied by Schering for eachpatient as provided in the

XIV. nizsie).

Vsetky vyssie uvedene povinnosti su pre prislusnustranu zavazne aostavaju platne aucinne vcelomrozsahu tak, ako je stanovene v tejto Zmluve.

7. Zdravotnicke zariadenie nezaradi do Snidie bezpredchadzajuceho suhlasu spolocnosti Schering viac akopaf subjektov. Dalsie subjekty zaradi len spredchadzajucim suhlasom spolocnosti Schering.Schering si vyhradzuje pravo obmedzif naborpodanim pisomneho oznamenia, alebo podanimoznamenia telefonicky nasledovanom pisomnymoznamenim Institucii a Skusajucemu za ucelomzastavenia d'alsieho naboru pre Klinicke skusanie(,,Obmedzenie naboru ucastnikov"). Po prijatitakeho pisomneho oznamenia Institucia a Skusajucisuhlasia s tym, ze uz neprijmu d'alsich ucastnikovpre ucely Klinickeho skusania. PokiaT sa medzistranami pisomne nedohodlo inak, v pripade takehooznamenia o zastaveni d'alsieho naboru budiicelkove sumy splatne zo strany spolocnosti Scheringv zmysle tejto Zmluvy spravodlivo pomernerozdelene za pocet ucastnikov prijatych do dnatakeho oznamenia s tym, ze akekol'vek financneprostriedky za ucastnikov nad ramec Obmedzenianaboru ucastnikov, ktore Schering vopred vyplatilInstitucii, budu vratene spat' spolocnosti Schering.

VIII. DOKUMENTACIA A SPRAVY

1. Skusajuci a Institucia maju nasledovne povinnostivedenia dokumentacie a ohlasovaciu povinnosf:

(i) priprava a vedenie uplnycha presnych pisomnychzaznamov, vykazov,poznamok audajovsuvisiacich s Klinickymskusanim podl'a tejto Zmluvy;

(ii) priprava a predlozeniespolocnosti Schering(pravidelne a vcas pocastrvania tejto Zmluvy)vsetkych nespracovanychudajov a inych materialovpozadovanych v Protokole voforme riadne vyplnenych

Protocol. Case Report Forms andthe electronic database shall bethe exclusive property ofSchering and/or the Sponsor.

2. In compliance with the Protocol, the Investigator andthe Institution declare themselves responsible forreporting and following up all unexpected or seriousadverse events (as those terms are used in the Protocol)associated with any drug treatment given to patientsduring the Study to the appropriate authorities inaccordance with legal and regulatory requirements andthe Institution's standard practices. The Investigator andInstitution agree to notify Schering immediately (withintwenty-four (24) hours) after learning of any seriousadverse events (as that term is used in the Protocol)affecting any patient in the Study taking a Scheringproduct and (c) follow up such notification of seriousadverse events affecting any patient in the Study taking aSchering product with appropriate reports in accordancewith Schering and/or Sponsor's reasonable requests, andall applicable legal and regulatory requirements. TheInvestigator and Institution agree to notify Scheringimmediately (within twenty-four (24) hours) afterlearning of any such follow-up information.

3. The Investigator and Institution are obliged toconduct the Study and maintain records and data duringand after the term or early termination of the validity ofthis Agreement in compliance with all applicable legaland regulatory requirements.

4. The Investigator and Institution undertake to permitSchering or Schering's authorized representatives toexamine and audit all records and reports, with prior

formularov pre zaznamyo hodnotenych ucastnikoch(,,Formulare pre zaznamyo hodnotenych ucastnikoch")alebo v elektronickej databaze(t.j. zadavanie udaj o v nadiaflcu) dodanychspolocnost'ou Schering prekazdeho ucastnika, ako j euvedene v Protokole.Formulare pre zaznamyo hodnotenych ucastnikocha elektronicka databaza siivylucnym majetkomspolocnosti Schering a/aleboZadavatel'a.

2. Skusajuci alnstitucia prehlasuju v sulades Protokolom, ze su zodpovedni za ohlasovaniea presetrenie vsetkych neocakavanych alebozavaznych neziaducich udalosti (ako su tieto pojmypouzite v Protokole) spojenych s akoukol'vek liecbouliekmi podavanymi ucastmkovi pocas KlinickehoskuSania prislusnymi uradmi v sulade s pravnymia regulacnymi poziadavkami a standardn^anipostupmi Institucie. Skusajuci alnstitucia suhlasias tym, ze Schering informuju okamzite (dodvadsiatich styroch (24) hodin) od momentu, kedy sadozvedeli o akychkol'vek zavaznych neziaducichudalostiach (ako je tento pojem pouzity v Protokole)ovplyvnujucich akehokol'vek ucastnika pri Klinickomsku§ani uzivajuceho produkt spolocnosti Schering a(c) presetrif take oznamenie o zavaznych neziaducichudalostiach ovplyvnujucich akehokol'vek ucastnika vKlinickom skusani uzivajuceho produkt spolocnostiSchering s tym, ze vypracuju riadne spravy v sulades primeranymi poziadavkami spolocnosti Scheringa/alebo Zadavatel'a, avsetkymi platnymi pravnymia regulacnymi poziadavkami. Skusajuci a histiniciasuhlasia stym, ze Schering informuju okamzite (dodvadsiatich styroch (24) hodin) od momentu, kedy sadozvedeli o akokol'vek takom presetrovani.

3. Skusajuci alnstitucia su povinni vykonafKlinicke skusanie auchovaf zaznamy audaje pocasa aj po skonceni alebo predcasnom ukonceniplatnosti tejto Zmluvy v sulade so vsetkymiplatnymi pravnymi a regulacnymi poziadavkami.

4. Skusajuci a Institucia sa zavazuju, ze povolia

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written notification from Schering and during normalbusiness hours (subject to applicable patientconfidentiality considerations).

5. The Investigator is obliged to notify Schering withintwenty-four (24) hours in the event that the regulatoryauthority notifies the Study site of a pendinginspection/audit. In addition, the Investigator shallforward to Schering any written communication receivedas a result of the inspection/audit within twenty-four (24)hours of receipt of such communication and agrees toallow Schering to assist in responding to any comments.Such responses shall be made within two (2) weeks ofissuance of any comments or within any earlier deadlineset by the issuing regulatory authority. The Investigatorshall also provide to Schering copies of any documentsprovided to any inspector or auditor.

DC. DATA PROTECTION

1. For the purposes of this Article, the followingdefinitions shall apply:

"Data" means all information obtained by theInstitution in performing the Services including PersonalData, statistical information, research, data, results andConfidential Information;

Data Protection Legislation" means, in particular,the provisions of Act No. 428/2002 Coll. on (personal)data protection, in the wording of later amendment, ActNo. 576/2004 Coll. as amended, the Data ProtectionDirective 95/46/EC, any relevant national implementationof this Directive or any other relevant regulation orstatutory or regulatory measure;

2. The Institution and Investigator undertake, only wherethey are processing Study Data under this Agreement:

a/ to process the Study Data only in accordancewith the terms of this Agreement, the Protocol, thepatient's informed consent (where required) and inaccordance with Schering and/or Sponsor's instructionsfrom time to time:

spolocnosti Schering alebo opravnenym/poverenymzastupcom spolocnosti Schering preskumanie aaudit vsetkych zaznamov a sprav,s predchadzajucim pisomnym oznamenim zo stranyspolocnosti Schering a pocas beznych pracovnychhodin (podliehajuc platnym ustanoveniam o ochraneosobnych udajov ucastnika).

5. Skusajuci je povinny do dvadsiatich styroch (24)hodin upovedomif Schering v pripade, ak regulacnyurad informuje pracovisko, kde sa vykonava Klinickeskusanie, o bliziacej sa kontrole/audite. Okrem tohoSkusajuci preposle spolocnosti Schering akukol'vekpisomnu komunikaciu prijatu v dosledkukontroly/auditu do dvadsiatich styroch (24) hodin odprijatia takej komunikacie asuhlasf stym, aby bolospolocnosti Schering umoznene spolupracovaf priodpovedani na akekol'vek pripomienky. Takeodpovede budu uskutocnene do dvoch (2) ryzdnov odvydania akychkol'vek pripomienok alebo doakehokol'vek skorsieho terminu stanovenehovydavajucim regulacnym uradom. Skusajuci taktiezposkytne spolocnosti Schering kopie akychkol'vekdokumentov poskytnutych akemukol'vek kontrolorovialebo auditorovi.

IX. OCHRANA UDAJOV

1. Na ucely tohto clanku platia nasledovne definicie:

,,Udaje" znamenaju vsetky informacie ziskaneInstituciou pri vykonavani Sluzieb, vratane Osobnychudajov, statistickych informacii, vyskumu, udajov,vysledkov a Dovernych informacii;

,,Predpisy o ochrane udajov" znamenajunajma ustanovenia zak. c. 428/2002 Z. z. o ochraneosobnych udajov, v zneni neskorsich predpisov, zak.c. 576/2004 Z. z. v zneni neskorsich predpisov,Smernicu o ochrane osobnych udajov 95/46/ES,akukolVek prislusnu vnutrostatnu implementaciu tejtoSmernice alebo akykol'vek iny relevantny predpisalebo zakonne alebo regulacne opatrenie;

2. mstitucia a Skusajuci sa zavazuju iba v pripade,kedy spracuvaju Udaje Klinickeho skusania podl'atejto Zmluvy:

a/ spracuvat' Udaje Klinickeho skusania iba vsulade s podmienkami tejto Zmluvy, Protokolom,

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b/ to ensure that only such of its employeeswho may be required by the Institution to assist it inmeeting its obligations under this Agreement shall haveaccess to the Study Data;

c/ to assist Schering, to a reasonable extentand promptly with all subject information requests whichmay be received from Study participants who are thesubject of Study Data;

d/ with the exception of the authorizedauditing bodies not to disclose the Study Data to a thirdparty in any circumstances other than at the specificrequest of Schering and/or Sponsor or with its consent;

e/ not to transfer Study Data to any person orpersons located outside the European Economic Areawithout the prior written consent of Schering;

f7 to allow their data processing facilities,procedures and documentation which relate to Study datato be scrutinised by Study Monitors in order to ascertaincompliance with the Data Protection Legislation; and

g/ to have in place such technical andorganizational measures as are reasonably necessary andappropriate to safeguard against the unauthorised orunlawful processing of Study Data and against accidentalloss or destruction of, or damage to, Study Data.

3. The Institution and Investigator undertake not touse or make available itself or through any other party,any information (including Study Data) obtained as aresult of conducting the Study, all of which is the propertyof Sponsor and/or Schering.

4. All right, title and interest in the Study Data shallvest exclusively in Schering and/or the Sponsor. TheInstitution and the Investigator undertake to provideadequate coperation, if requested by Schering, to evidencetransfer of title of all research data and results to Sponsor

informovanym suhlasom ucastnika (v pripadoch, kedyje potrebny) avpripade potreby v sulade spokynmispolocnosti Schering a/alebo Zadavatel'a;

b/ zabezpecit', ze iba taki ich zamestnanci,ktorych asistenciu pri plneni svojich povinnosti podl'atejto Zmluvy moze pozadovat' Institucia, budii mat'pristup k Udajom Klinickeho skusania;

c/ promptne poskytovat' primeranusucinnost' spolocnosti Schering pri vsetkychziadostiach o informacie, ktore mozno obdrzaf oducastnfkov klinickeho skusania, ktori su predmetomUdajov Klinickeho skusania;

d/ nezverejnif Udaje Klinickeho skusaniatretej strane, okrem opravnenych konktrolnychorganov, za ziadnych okolnosti iba na vyslovnuziadosf spolocnosti Schering a/alebo Zadavatel'aalebo s jeho suhlasom;

e/ nepreviest' Udaje Klinickeho skusaniaziadnej osobe alebo osobam nachadzajucim sa mimoEHP bez predchadzajuceho pisomneho suhlasuspolocnosti Schering;

f7 umoznif preskumanie svojich zariadeni naspracuvanie udajov, posrupov a dokumentacietykajucej sa Udajov Klinickeho skusania Osobamiurcenymi na monitorovanie Klinickeho skusania zaucelom preukazania suladu s Predpismi na ochranuudajov; a

g/ mat' na pracovisku nalezite potrebne aprimerane technicke aorganizacne opatrenia protineopravnenemu alebo nezakonnemu spracuvaniuUdajov Klinickeho skusania a proti nahodnymstratam, zniceniu alebo poskodeniu UdajovKlinickeho skusania.

3. Institucia a Skusajuci sa zavazuju nepouzivaf, aninespristupnif sebe, ani prostrednictvom akejkol'vektretej strany, ziadne informacie (vratane UdajovKlinickeho skusania) nadobudnute pri vykoneKlinickeho skusania, ktore su vsetky vlastnictvomZadavatel'a a/alebo spolocnosti Schering.

4. Vsetky prava, naroky apodiely na UdajochKlinickeho skusania patria vylucne Zadavatel'ovia/alebo spolocnosti Schering. Institucia a Skusajuci

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u

and/or Sobering.

5. The Institution and Investigator undertake thatthey will not use the Study Data or any part thereof fortheir own business purposes unless prior permission hasbeen sought and granted in writing from Sponsor and/orSobering.

X. PRICE AND PAYMENT CONDITIONS

1. Sobering shall provide financial remuneration toInstitution in such amounts as are set out in, andotherwise in all respects in accordance with, Exhibit A.

2. The Institution shall issue and send to Sobering aninvoice for payment of remuneration according to theschedule set forth in Exhibit B.

3. In addition to the payments according to Exhibits Aand B, Sobering undertakes to reimburse theInstitution's and the Investigator's reasonable anddocumented out-of-pocket travel and other expensesincurred in connection with the services providedhereunder in accordance with the Reimbursement Policycontained in Exhibit A within sixty (60) days of receiptand approval of written invoice(s) and reasonablesupporting documentation.

4. The Parties agree and confirm that the amount offinancial remuneration provided hereunder isreasonable, fair market value and is commensurate withthe work performed by Institution hereunder.

5. Each Party acknowledges that all sums paid tothe Institution by Sponsor under the terms of thisAgreement are in respect of the services set forth in thisAgreement or the reimbursement of expenses theInstitution incurs in connection with the servicesprovided hereunder. Each Party acknowledges that thepayments are not connected with the supply orpromotion of Sobering products, and are not conditionalon the prescription, administration, recommendation orpurchase of any such products; and further confirms thatpayments hereunder represent reasonable, fair marketvalue for services rendered.

sa zavazuju, ze na ziadosf Zadavatel'a poskytnuprimeranu sucinnosf na preukazanie prevodu pravaku vsetkym vyskumnym udajom avysledkom naZadavatel'a a/alebo Schering.

5. Institucia a Skusajuci sa zavazuju, ze nebudiipouzivaf Udaje Klinickeho skusania alebo akukol'vekich cast5 pre svoje vlastne obchodne ucely, pokiaTnepoziadaju Zadavatel'a a/alebo Schering o suhlasa tento im ho neudeli v pisomnej forme vopred.

X. CENA A PLATOBNE PODMIENKY

1. Schering poskytne Institucii financnu odmenuv takych sumach, ake su uvedene v Prilohe A a inakvo vsetkych ohl'adoch v sulade s nimi.

2. Institucia vystavi a zasle spolocnosti Scheringfakturu na platbu odmeny podl'a planu uvedenehov Prilohe B.

3. Schering, mimo platieb podl'a Prilohy A aB sazavazuje, ze uhradi Institucii a Skusajucemu ichprimerane adokladovane hotove cestovne a mevydavky vzniknute v suvislosti so sluzbamiposkytovanymi na zaklade tejto Zmluvy v sulade soZasadami preplacania uvedenych v Prilohe A dosesfdesiatich (60) dm od prijatia a schvaleniapisomnej faktury/faktur a prislusnej podkladovejdokumentacie.

4. Zmluvne strany sa dohodli a potvrdzuju, zeciastka financnej odmeny poskytnuta na zakladetejto Zmluvy je primerana a spravodliva trhovahodnota aje adekvatna praci, ktoru na zaklade tejtoZmluvy vykonava Institucia.

5. Kazda zmluvna strana potvrdzuje, ze vsetkyciastky vyplatene Zadavatel'om Institucii podl'apodmienok tejto Zmluvy sa tykaju sluziebuvedenycb v tejto Zmluve alebo ze preplatenienakladov, ktore vznikli Institucii, sa tyka sluziebposkytovanych na zaklade tejto Zmluvy. Kazdazmluvna strana potvrdzuje, ze platby sa netykajudodavania alebo propagacie vyrobkov spolocnostiSchering, a nie su podmienene predpisom, podanim,odporucanim alebo kupou akychkol'vek takychvyrobkov; a d'alej potvrdzuju, ze platby uskutocnenena zaklade tejto Zmluvy predstavuju primeranua spravodlivu trhovu hodnotu za poskytnute sluzby.

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XI. CONFIDENTIAL INFORMATION

1. During and for a period often (10) years after the termor early termination of this Agreement, Investigator andInstitution agree to treat as confidential any and all data,documentation and materialsa) disclosed or supplied to either Investigator and/orInstitution by Sponsor and/or Schering in connection withthis Agreement orb) generated during the conduct of the Study (hereinafter"the Confidential Information") and not to disclose suchConfidential Information or permit it to be disclosed toany third party.

2. Should applicable law provide for a longer period orindefinite time period for keeping confidentiality (e.g. asapplicable for business secrets or patients' records), suchperiod shall than be applied.

3. Where the law or a binding decision requires that suchdata are disclosed to a public authority, the Institution andthe Investigator shall take all necessary steps to make sureConfidential Information is not disclosed by that authorityto third parties, in particular by properly marking theConfidential Information as being subject of tradesecrecy, intellectual property protection and DataProtection Legislation.

4. Sponsor, Schering, Investigator and Institution furtherundertake not to use the Confidential Information for anyother purpose than the purposes of this Agreement.

XII. PUBLICATIONS AND OTHER RIGHTS

In recognition of the importance ofdisseminating information relating to any novel orimportant observations or results arising from the Study,Institution and Investigator, either individually orcollectively, shall not publish or present data from theStudy or Study results without the express writtenconsent of Sponsor and/or Schering in each instance,which such consent may be withheld for any or noreason.

XIII. INVENTIONS AND PATENTS

XI. DOVERNEINFORMACIE

1. Pocas doby platnosti tejto Zmluvy a pocas dobynajmenej desiatich (10) rokov po skonceni alebopredcasnom ukonceni tejto Zmluvy, Skusajuci aInstitucia zachovaju mlcanlivosf o vsetkych udajoch,dokumentacii a materialocha) zverejnenych alebo poskytnutych Skusajucemua/alebo Institiicii zo strany ZadavateFa a/alebospolocnosti Schering v suvislosti s touto Zmluvou,alebob) vytvorenych pocas vykonu Klmickeho skusania(d'alej len ,,D6verne informacie") anezverejnia takeDoverne informacie, ani nepovolia ich zverejnenieakejkol'vek tretej strane.

2. Ak prislusny pravny predpis ustanovuje dlhsiulehotu alebo neobmedzene casove obdobie prezachovanie mlcanlivosti (napr. pri obchodnomtajomstve alebo zdravotnej dokumentacii), bude platiftato dlhsia lehota.

3. Vpripadoch, kedy pravny predpis alebo zavaznerozhodnutie vyzaduju zverejnenie takych udajovuradu verejnej spravy, Institucia a Skusajuci podnikmivsetky nevyhnutne kroky, aby tieto Doverneinformacie organ verejnej spravy neposkytol tretejosobe, a to najma tak, ze Doverne informacie riadneoznacia ako predmet obchodneho tajomstva, ochranydusevneho vlasmictva a Predpisov o ochrane udajov.

4. Zadavatel', Schering, Skusajuci a Institucia sad'alej zavazuju, ze nepouziju Doverne informacie naakekoIVek ine ucely nez na ucely tejto Zmluvy.

XII. PUBLIKACIE A OSTATNE PRAVA

Institucia a Skusajuci, samostatne alebospolocne, sue si vedomi dolezitosti rozsirovaniainformacii tykajucich sa akychkol'vek novych alebodolezitych pozorovani alebo vysledkovvyplyvajuclch z Klinickeho skusania, nesmupublikovaf alebo prezentovat' udaje vyplyvajucez Klinickeho skusania alebo zjeho vysledkov bezpredchadzajuceho pisomneho suhlasu Zadavatel'aa/alebo spolocnosti Schering v kazdom takompripade, pricom taky suhlas nemusf byt' udelenys udanim ale aj bez udania dovodu.

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1. The (investigator and Institution acknowledge Sponsorand/or Schering's proprietary rights and interest in alldata, documentation and materials disclosed to it bySponsor under this Agreement as well as in all materials,including samples and specimens, used or obtained in theStudy. The results of the Study and all documentationgenerated therein (including CRF's) and any or allintellectual property rights, including copyright, in suchdata documentation and materials, shall vest exclusivelyin Sponsor and/or Schering.

2. The Investigator and Institution shall promptly discloseand assign to Sponsor and/or Schering or its nominee anydiscovery or invention made by the Investigator inconnection with the Study. Title to all such inventionsshall belong to Sponsor. The results of the Study and alldocumentation generated herein (including CRF's andany or all intellectual property rights, including copyright,in such data documentation and materials) shall restexclusively with Sponsor.

3. If Sponsor and/or Schering believes there is patentablesubject matter contained in any Public Presentationsubmitted for review, Schering shall promptly identifysuch subject matter to the Investigator. If Sponsorrequests and at Schering's expense, the Investigator shalluse his or her best efforts to assist Schering to file a patentapplication covering such subject matter prior to anypublication.

XIV. NOTICES

1. Whenever any notice is to be given hereunder, it shallbe in writing and mailed postage prepaid by certified orregistered mail (including major international couriersuch as FedEx, UPS, DHL, etc.), return receiptrequested, or personally delivered to the appropriateParty at the relevant address below:

XIII. VYNALEZY A PATENTY

1. Skusajuci alnstitucia uznavaju vlastnicke pravaanarok Zadavatel'a a/alebo spolocnosti Schering navsetky udaje, dokumentaciu a materialy im zverejnenena zaklade tejto Zmluvy, ako aj na vsetky materialy,vratane vzoriek aexemplarov, pouzitych aleboziskanych pri Klinickom skusani. VysledkyKlinickeho skusania avsetkej pri nom vytvorenejdokumentacie (vratane Formularov pre zaznamy ohodnotenych ucastnikoch) a akekol'vek ine pravadusevneho vlasmictva, vratane autorskeho prava,v takej dokumentacii a materialoch su vylucnymmajetkom Zadavatel'a a/alebo spolocnosti Schering.

2. Skusajuci alnstitucia bezodkladne informujuZadavatel'a a/alebo Schering alebo jehosplnomocnenca aposuipia na nich akykol'vek objavalebo vynalez vytvoreny Skusajucim v suvislostis Klinickym skusanim. Vlastnicke pravo k vsetkymtakym vynalezom nalezi Zadavatel'ovi. VysledkyKlinickeho skusania avsetkej pri nom vytvorenejdokumentacie (vratane Formularov pre zaznamy ohodnotenych ucastnikoch a akekol'vek ine pravadusevneho vlasmictva, vratane autorskeho prava,v takej dokumentacii a materialoch) su vylucnymmajetkom Zadavatel'a.

3. Ak je Zadavatel' a/alebo Schering presvedceny, zeakakolVek Verejna prezentacia predlozena napreskumanie obsahuje patentovatel'ny predmet,Schering bezodkladne upovedomi Skusajucehoo takom predmete. Na ziadosf spolocnosti Scheringa na naklady spolocnosti Schering Skusajuci vynalozimaximalne usilie za ucelom poskytnutia sucinnostispolocnosti Schering pri podavani patentovej ziadosti,ktora pokryva taky predmet, este pred akymkol'vekzverejnenim.

XTV. OZNAMOVANIE

1. Akekol'vek oznamenie vyplyvajuce z tejtoZmluvy musi byf vyhotovene v pisomnej formea zaslane s vopred uhradenym postovnymdoporucenou postou (vratane najvacsichmedzinarodnych kurierskych spolocnosti, ako napr.FedEx, UPS, DHL atd'.) s navratkou, alebo

15

For Sphering:

Schering-Plough, s.r.o., Clinical Operations department,Mlynske nivy 43, 821 09 Bratislava, Slovak Republic

For the Institution:Univerzitna nemocnica L. Pasteura KosiceRastislavova 43, 041 90 Kosice, Slovenska republika(the Slovak Republic)

For the Investigator:Doc.MUDr. Jozef Firment, PhD.Univerzitna nemocnica L. Pasteura KosiceI.Klinika anesteziologie a intenzivnej medicmyTrieda SNP 1, 041 90 Kosice, Slovenska republika

2. If not specified otherwise elsewhere in theAgreement, a notice shall be deemed to have beenreceived at the earlier of receipt or five (5) days fromthe date of mailing (in the case of a letter). In case ofchange of an address stated in item 1 in this paragraph,the respective Party shall notify the other Parties aboutthis change by an amendment to this Agreement.

XV. Conflict of interests

16.1 Investigator represents and warrants that, otherthan as set forth below, he/she or a member of his / herimmediate family relatives (including married andunmarried spouse; siblings, children, parents,grandparents) is not employed or engaged, whether paidor unpaid, in any of the following functions andpositions in a capacity that could allow to Investigatorto influence business of Sponsor, Schering or any othercompany of corporation Schering-Plough, subsidiary ofMerck & Co., Inc., Whitehouse Station, NJ, U.S.A,including parent companies, subsidiaries or affiliates(further only "company Schering-Plough"), mainly:(a) as government official or Insurance Company(regardless if it is named position or not) (including arelationship with a governmental official which couldcause the official to influence the business of companySchering-Plough);(b) on or serving in an official capacity to anyreimbursement committee, pricing committee, drugapproval committee, formulary or similar committee(i.e.State Institute for Drug Control or Ministry of Health),

dorucene osobne prislusnej zmluvnej strane naadresu uvedenu nizsie:

Pre Schering:

Schering-Plough, s.r.o., Klinicke oddeleni, MlynskeNivy 43, 821 09 Bratislava, Slovenska republika

Pre Instituciu:Univerzitna nemocnica L. Pasteura KosiceRastislavova 43, 041 90 Kosice, Slovenskarepublika

Pre Skusajuceho:Doc.MUDr. Jozef Firment, PhD.Univerzitna nemocnica L. Pasteura KosiceI.Klinika anesteziologie a intenzivnej medicmyTrieda SNP 1, 041 90 Kosice, Slovenska republika

2. Oznamenie sa povazuje za dorucene najskordnom jeho prijatia alebo pat' (5) dni od darumuodoslania (ak ide o list), ak vtejto zmluve nie jeuvedene inak.. Pri zmene uvedenej adresy v bode 1tohoto clanku je prislusna zmluvna strana povinnaoznamit' zmenu svojej adresy druhej zmluvnejstrane a to predlozenim dodatku k tejto smluve.

XV. Konflikt z6ujmov

16.1 Skusajuci prehlasuje a zarucuje, ze ani on/ona aninikto zjeho/jej blizkych osob (vratane manzelky/manzela,druzky/druha, surodencov, deti, rodicov, prarodicov) nie jev pracovnopravnom ani v inom odplatnom cibezodplatnom pravnom vzfahu, vziadnej z nizsieuvedenych funkcii v postavem, ktore by Skusajucemumohlo umoznovaf ovplyvnovat' podnikanie Zadavatel'a,Schering alebo akejkol'vek spolocnosti patriacej doskupiny spolocnosti Schering-Plough, sucasf Merck & Co.,Inc., Whitehouse Station, NJ, U.S.A, vratane materskychspolocnosti, dcerskych spolocnosti a organizacnych zloziek(d'alej len "spolocnosf Schering-Plough"), najma ze:a) nie je zamestnancom organu verejnej spravy alebopoisfovne (bez ohl'adu na pomenovanie pozicie) (vratanevzfahu stakymto zamestnancom organu verejnej spravy,na zaklade ktoreho by Skusajuci mohol ovplyvnovat'podnikanie spolocnosti Schering-Plough);b) nie je clenom akejkolVek komisie rozhodujucej ouhradach liekov, cenach liekov, alebo schval'ujucejregistraciu liekov, kategorizacnej komisie alebo inejkomisie ci podobneho organu v ramci spravneho organu

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or of the health insurance company or is not the officialconsultant to such comities or bodies;(c) in any other governmental position, including aposition in an international governmental healthorganization, such as the WHO (World HealthOrganization) or UNICEF.

16.2 Investigator will advise Schering to the extenthis / her status described in the prior sentence changesduring the term of this Agreement.

16.3 Investigator represents and warrants that he/shewill not make any payment, either directly or indirectly,of money or other assets, including but not limited tocompensation paid under this Agreement, togovernment or political party officials, candidates forpublic office, or representatives of other businesses orpersons acting on their behalf, where such payment isfor the purpose of influencing decisions or actions withrespect to any aspect of business of company Schering-Plough.

16.4 The principal Investigator has advised Scheringthat he is a head of department of Anesthesy andintensive care in Univerzitna nemocnice L.PasteuraKosice, member of Slovak assiciation for Anesthesy andintensive care, and regional specialist for anesthesiologyfor district Kosice. Without waiving the Confidentialityprovisions of this Agreement, Institution, Schering andInvestigator agree that Investigator undertakes todisclose the nature of his/her relationship with Scheringto the relevant Committee / Body and/or his/heremployer before any decision of Medical Association orbefore any other decision that could affect business ofSchering-Plough and before he/she participates to anysuch decision.

XVI. ASSIGNMENT

1. The Institution is not entitled to assign or transfer therights and obligations arising from the Agreement toany third party without the prior written approval ofSchering.

2. Schering is entitled to assign or transfer the rights andobligations hereunder without the prior writtenapproval by the Institution, except Schering financial

(napr. Statneho listavu pre kontrolu lieciv ani Ministerstvazdravotnictva) alebo poisfovne alebo oficialnyposkytovatel' sluzieb/poradca akebokol'vek z uvedenychkomsii/organov;c) nezastava akukol'vek inu verejnu funkciu vratanefunkcie v medzinarodnej zdravotnickej organizacii ako jeWHO (Svetova zdravotnfcka organizacia) alebo UNICEF.

16.2 Skiisajiici sa zavazuje informovafspolocnosf Schering v pripade, ak sa jeho/jej postavenie vovyssie uvedenom zmysle pocas platnosti tejto pisomnejzmluvy zmeni, pricom musi tiez spolocnosf Scheringinformovaf do akej miery sa jeho/jej postavenie zmenilo.

16.3 Skusajiici prehlasuje a zarucuje, zeneuskutocni ziadnu priamu alebo nepriamu platbuv hotovosti alebo vo forme inej majetkovej hodnoty najmaneposkytne odmenu zodpovedajucu odmene vyplatenejmu/jej na zaklade tejto zmluvy ziadnemu zamestnancovistatnej alebo verejnej spravy, zastupcovi politickychstran/hnuti, kandidatom na verejnu funkciu, ani zastupcominych podnikatel'skych subjektov ci osobam konajucim nazaklade ich poverenia, pokiaT by ciel'om tejto platby bobovplyvnenie rozhodovania alebo konania vo vzt'ahuk akemukol'vek aspektu podnikana spolocnosti Schering-Plough.

16.4 Hlavny skiisajuci oboznamilspolocnosf Schering, ze je prednostom I.Klinikyanesteziologie a intenzivnej mediciny Univerzitnejnemocnice L.Pasteura Kosice, clenom Slovenskejspolocnosti pre anesteziologiu a intenzivnu medicuiu aKrajskym odbomikom pre anesteziologiu pre Kosicky kraj.Bez toho aby sa tym ktorakol'vek zo zmluvnych stranvzdavala prava na zachovanie mlcanlivosti, Institucia,Skusajiici a spolocnosf Schering sa dohodli, ze Skusajiicipred akymkoPvek hlasovanfm o rozhodnuti odbornejspolocnosti alebo pred akymkol'vek rozhodnutim, ktore bymohlo ovplyvnif podnikanie spolocnosti Schering, oznamisvoj obchodny vzfah k spolocnosti Schering, prislusnejkomisii /organu a/alebo svojmu zamestnavaterovi v ramcihlavneho pracovneho pomeru a to predtym, ako sa zucastnfakehokol'vek rozhodnutia, ktore by mohlo ovplyvnifpodnikanie spolocnosti Schering-Plough.

XVI. POSTUPENIE

1. Institucia nie je opravnena postupif alebopreviesf prava a povinnosti z tejto zmluvyvyplyvajiice na akukol'vek tretiu osobu bezpredchadzajuceho pisomneho suhlasu spolocnostiSchering.

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obligations towards Institution from this Agreement,which can be delegated only with the agreement by theInstitution in writing.

3. The Investigator is not entitled to transfer its rightsand obligations arising from its status of the Investigatorunder this Agreement to any natural person.

XVII. APPLICABLE LAW

1. This Agreement shall be governed by the law of theSlovak Republic.2. Law relationships that are not specifically regulatedby the Agreement shall be subject to the respectiveprovisions of Act No. 513/1991 Coll., CommercialCode, in the wording of later regulations.

XVIII. PUBLICITY

1. Neither Party shall use the name of the other Party (orthe name of Schering or any division or affiliatedcompanies) for promotional purposes without the priorwritten consent of the Party whose name is proposed tobe used.

2. No news release, publicity or other publicannouncement, either written or oral, regarding thisAgreement or performance hereunder or results arisingfrom the Study, shall be made by the Institution withoutthe prior written approval of Schering.

XIX. INDEPENDENT CONTRACTOR

1. It is agreed by the Parties that the Institution andInvestigator are acting in the capacity of independentcontractors hereunder and not as employees, agents orjoint ventures of or with Schering.

2. Neither the Institution nor Investigator shall have anyauthority to represent, bind or act on behalf of Schering.

XX. AGREEMENT MODIFICATIONS

2. Schering je opravneny postupit' alebo previest'prava apovinnosti ztejto zmluvy bezpredchadzajuceho pisomneho suhlasu Institucie,okrem financnych zavazkov Schering voci Instituciivyplyvajucich z tejto zmluvy, ktore je opravnenypreviesf len s pisomnym suhlasom Institucie.

3. Skusajuci nie je opravneny preniesf svoje pravaa povinnosti vyplyvajuce mu z postaveniaskusajuceho podl'a tejto zmluvy na inii fyzickuosobu.

XVII. PLATNfE PRAVO

1. Tato Zmluva sa riadi pravnym^ predpisomSlovenskej republiky2. Pravne vzt'ahy osobitne v tejto zmluveneupravene sa riadia prislusnymi ustanoveniami zak.c. 513/1991 Zb. Obchodny zakonnik v znenineskorsich predpisov.

XVIII. PUBLICITA

V

1. Ziadna strana nepouzije meno druhej strany(alebo meno spolocnosti Schering, akejkol'vekdivizie alebo pridruzenych spolocnosti) napropagacne ucely bez predchadzajuceho pisomnehosuhlasu strany, ktorej meno sa ma pouzif.

2. Institucia nesmie vydaf ziadne spravy,propagacne ani ine verejne oznamenia, pisomnealebo ustne, tykajuce sa tejto Zmluvy alebo vykonupovinnosti z nej vyplyvajucich, ani spravy ovysledkoch Klinickeho skusania bezpredchadzajuceho pisomneho suhlasu spolocnostiSchering.

XIX. NEZAVISLY DODAVATEE

1. Zmluvne strany sa dohodli, ze Institucia aSkusajuci za tychto podmienok konaju ako nezavislfdodavatelia a nie ako zamestnanci, zastupcoviaalebo ako podnik s majetkovou ucasfou spolocnostiSchering.

2. Ani Institucia ani Skusajuci nemaju ziadne pravozastupovaf, zavazovaf, ani konat' v mene

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This Agreement may be altered and/or amendedor modified only by written document signed by bothParties.

XXI. SEVERABILITY

If any term or condition of this Agreement, thedeletion of which would not adversely affect the receiptof any material benefit by either Party hereunder, shallbe held illegal, invalid or unenforceable, the remainingterms and conditions of this Agreement shall not beaffected thereby and such terms and conditions shall bevalid and enforceable to the fullest extent permitted bylaw.

XXII. NO WAIVER

Failure on the part of any Party to exercise orenforce any right conferred upon it hereunder shall notbe deemed to be a waiver of any such right nor operateto bar the exercise or enforcement thereof at any time ortimes thereafter.

XXIIL FORCE MAJEURE

Non-compliance by either Party with theobligations of this Agreement due to force_majeure (lawsor regulations, war, civil commotion, destruction ofproduction facilities and materials, fire, flood, earthquakeor storm, labour disturbances, shortage of materials,failure of public utilities or common carriers), or anyother causes beyond the reasonable control of theapplicable Party, shall not constitute breach of thisAgreement and such Party shall be excused fromperformance hereunder to the extent and for the durationof such prevention, provided it first notifies the otherParty in writing of such prevention and that it uses its bestefforts to cause the event of the force majeure toterminate, be cured or otherwise ended.

spolocnosti Schering.

XX. ZMENY ZMLUVY

Tato Zmluva moze byt' zmenena a/alebo,doplnena alebo upravena iba na zaklade pfsomnehododatku podpisaneho oboma zmluvnymi stranami.

XXI. ODDELITEENOSt

Ak sa ktorekol'vek ustanovenie tejto Zmluvy,neplatnosf ktoreho by nepriaznivo neovplyvnilaprijatie akehokol'vek materialneho prospechuzmluvnou stranou v zmysle tejto Zmluvy, stanenezakonnym, neplatnym alebo nevymoziternym,ostatne ustanovenia tejto Zmluvy nebudu tymtoovplyvnene, pricom tieto ustanovenia ostanu ajnad'alej v platnosti a budu vymozitel'ne v plnomrozsahu povolenom pravnym poriadkom.

XXII. VZDANIE SA PRAVA

Vykonavanie alebo nevymahanie prava,ktore prinalezi ktorejkol'vek zmluvnej stranev zmysle tejto Zmluvy, sa nepovazuje za vzdanie saakehokol'vek takeho prava, ani sa tymto nepozastavivykon alebo vymoziteFnosf tohto prava kedykol'vekneskor.

XXIIL VYSSIAMOC

Neplnenie zavazkov vyplyvajucich z tejtoZmluvy zmluvnou stranou zapricinene vyssou mocou(zakonmi alebo pravnymi predpismi, vojnou,obcianskymi nepokojmi, znicenim vyrobnychzariadeni alebo materialov, poziarom, zaplavami,zemetrasenim alebo burkami, pracovnymi nepokojmi,nedostatkom materialov, pochybenim dodavatefovverejnych sluzieb alebo verejnych dopravcov) alebo zakychkol'vek inych pricin mimo primeranej kontrolyprislusnej zmluvnej strany, sa nebude povazovaf zaporusenie tejto Zmluvy, pricom takato zmluvna stranabude oslobodena od vykonu zavazkov vyplyvajucichz tejto Zmluvy v rozsahu a pocas doby trvania tejtoprekazky, za predpokladu, ze tato zmluvna strananajprv pisomne oznami druhej zmluvnej strane vyskyttakejto prekazky, pricom tato zmluvna strana vynalozimaximahie usilie na ukoncenie trvania pripadu vyssej

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XXIV. ENTIRE UNDERSTANDING

1. This Agreement, together with all of the exhibits,schedules and addenda hereto (including those to bedelivered), constitutes the entire agreement between theParties with respect to the subject matter hereof.

2. This Agreement supersedes and cancels all previousagreements among the Parties, written and oral inrespect of the subject matter hereof.

3. In the event of any inconsistency between thisAgreement and the attached Protocol, the terms of thisAgreement shall govern except with regard to adverseevent reporting procedures which shall be governed bythe Protocol and any appendix or attachment thereto.

XXV.INVESTIGATOR

REPRESENTATION BY THE

By my signature as Investigator I acknowledge thatI was duly made acquainted with the contents of thisAgreement on co-operation with Schering / itsauthorized representative and on the conduct of theabove-mentioned clinical Study.I take cognizance of all of my legal and contractualobligations and the conditions of the execution of theStudy according to this Agreement and undertake toconsistently abide by them.I agree to secure that the Study staff and all Co-Investigators are informed about their obligationsaccording to this Agreement and consistently abide bythem.I declare that I will immediately initiate my employer(its site being the venue of the Study) to terminate theStudy as well as the validity of the Agreement in theevent that continued Study could put at risk a Studyparticipant - a patient, or cause other damages.At the same time, I hereby approve the use of mypersonal data in the way and within the extent specifiedin this Agreement.

moci, umoznenie napravy alebo ine odstranenie.

XXIV. UPLNA ZMLUVA

1. Tato Zmluva spolu so vsetkymi jej prilohamia dodatkami (vratane tych, ktore budu dorucene),predstavuje uplnu zmluvu medzi zmluvnymistranami tykajucu sa predmetu tejto Zmluvy.

2. Tato Zmluva nahradza a rusi vsetkypredchadzaj uce dohody uzatvorene medzizmluvnymi stranami, pisomne alebo ustne,vzt'ahujuce sa na predmet tejto Zmluvy.

3. V pripade akychkol'vek nezrovnalosti medzi toutoZmluvou a prilozenym Protokolom budurozhodujuce podmienky tejto Zmluvy, s vynimkoupripadov ohlasovacich postupov neziaducej udalosti,pre ktore bude rozhodujuci Protokol a akykol'vekjeho dodatok alebo priloha.

XXV. PREHLASENIE SKUSAJUCEHO

Svojim podpisom ako skiisajuci potvrdzujem, zesom bol riadne oboznameny s obsahom tejtoZmluvy, ktorej predmetom j e spolupraca sospolocnosfou Schering /jej splnomocnenymzastupcom avykonanie vyssie uvedenehoklinickeho skusania.Beriem na vedomie vsetky moje zakonne ajzmluvne dohodnute povinnosti a podmienkyvykonania klinickeho skusania podl'a tejto Zmluvya zavazujem sa ich dosledne plnit'.Suhlasim s tym, ze zabezpeci'm, aby personalskusania avsetci spoluskusajuci boli informovanfo ich povinnostiach podl'a tejto Zmluvy a tietodosledne plnili.Prehlasujem, ze budem bezodkladne iniciovat'u svojho zamestnavatel'a, na pracovisku ktoreho satoto klinicke skusanie vykonava, zastavenieskusania a ukoncenie platnosti Zmluvy, ak by mohlov pripade jeho pokracovania dojsf k ohrozeniuucastnika skusania - pacienta alebo inej skode.Zaroven tymto davani suhlas s pouzitim mojichosobnj'ch udajov sposobom a v rozsahu stanovenomv tejto Zmluve.

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INVESTIGATOR

Signature: Date:Doc. MUDr. J^zef Firment, PhD.

Signature: Date:MUDr. Blanka Kalnasova

Signature:MUDr. Tomas Sefara

Signature: ' "MUDr. Petr Firment

Date:

Date: £9-1. ?6

Signature: • Date:MUDr. Zuzana Liptakova

Signature: Date:MUDr. Zaneta Hutnanova

XXVI. ATTACHMENTS AND ADDENDA

The following attachments (Exhibits) make an integralpart of the Agreement:A/ Study BudgetB/ Payment Schedule

XXVII. FINAL PROVISIONS1. The Agreement comes into validity on the day ofexecution by the authorized representatives of bothParties and comes into effect a day after the publicationin the Central register of contracts.2. The Agreement has been executed in two bilingualcounterparts (in English and Slovak); the Slovakwording is decisive. Each of the Parties shall obtain onecopy of the Agreement.

BY: Univerzitna nemocnica L. Pasteura Kosicg

NAME: MUDr. Iveta Marinova, MPH

SKUSAJUCI

Podpis ' DatumDoc. MUDr. jozet'Firment, PhD.

Podpis c ./ Datum: ^f-6MUDr. Blanka Kalnasova

Podpis - ; Datum: ZfMUDr. Tomas Sefara

Podpis Datum : i $, 3 , 2<?MUDr. Petr Firment

Podpis ' ' Datum : £*• & ~ 7MUDr. Zuzana Liptakova

Podpis - - - Datum: ,MUDr. Zaneta Hutnanova

XXVI. PRILOHY A DODATKY

Nedelitel'nou siicast'ou tejto zmluvy su prilohyA/ Rozpocet pre klinicke skusanieB/ Plan platieb

XXVII: ZAVERECNE USTANOVENTA1. Tato zmluva nadobuda platnosf dnom

podpisania zmluvnymi stranami aucinnosfdnom nasledujucim po dni jej zverejneniav Centralnom registri zmliiv.

2. Zmluva je vyhotovena v dvoch dvojjazycnych(anglicko - slovensky) vyhotoveniach, pricompre vyklad aplnenie je rozhodujuce zneniezmluvy v slovenskom jazyku.. Kazda zmluvnastrana obdrzi jedno vyhotovenia zmluvy.

NAZOV: Univerzitna nemocnica L. PasteuraKosiceMENO: MUDr. Iveta Marinova.

FUNKCIA: riaditel' ,,i:;;,^i;.:ri":-(j ...juM'jti L. Pssteurs Kosice

GO K 0 S ! C ̂

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TITLE: Director

DATE:

BY: Schering-Plough, s.r.o.

NAME: MUDr. Peter Musil

TITLE: managing director

DATE:

DATUM:

NAZOV: Schering-Plough, s.r.o.

MENO: MUDr. Peter Musil

FUNKCIA: konatel'

DATUM:

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EXHIBIT A

Study Budget

Payment for completed subjects

Each satisfactorily completed CRFs will be reimbursedby Schering to a maximum of Euro 230 per onesubject's data over the course of the Study.

Reimbursement PolicyIn accordance with Schering's standard policies andprocedures, the following are types of expenses by theInstitution or the Investigator for which Schering willnot reimburse the Institution or the Investigator, unlessexpressly agreed to in a prior writing by the parties:

Taxi/Sedans/Limousines to and/or fromthe your place of business or residence(excluding taxis to and/or from airportfor Sponsor-requested business)First-class air travelAdd-on costs with respect to outsideservicesMark-up for the work product of outsideprofessionals, including but not limitedto freelancersMeals (except during travel inconnection with the services rendered toSchering)Administrative and/or overheadpercentagesAgency presentations for new businessGifts to Institution's employeesEntertainment of Institution's employeesMark-up on any out-of-pocket expensesHospitality for persons not associated orrelated to the work being performed forSchering

Note: This list sets forth the major items for whichSchering will not reimburse the Institution or theInvestigator and is meant to be merely illustrative andnot exhaustive. All expenses shall be reviewed withrespect to the reasonableness of such expenses.

PRILOHA A

Rozpocet pre Klinicke skusanie

Platba za ukoncenych ucastnikov

Kazdy prijatel'ne vyplneny Formular pre zaznamyo hodnotenych ucastnikoch bude spoplatnenyciastkou 230 Euro za udaje jedneho ucastnikav priebehu Klinickeho skusania.

PreplacanieV sulade s beznou praxou a postupmi spolocnostiSchering su nasledovne polozky typmi vydavkov zostrany mstitucie alebo Skusajuceho, ktore Scheringnebude preplacaf Institucii ani Skusajucemu, pokiaFsa strany vopred a v pisomnej forme vylucnenedohodli inak:

taxiky/sedany/limuziny do a/aleboz miesta vykonu cinnosti alebo sidla(okrem taxikov do a/alebo z letiskaza ucelom obchodu pozadovanehoZadavatel'om)letecka doprava prvou triedoudodatocne vydavky za externe sluzbyprirazky za vysledok prace externychodbomikov, vratane, nie vsakvylucne, samostatne zarobkovocinnych osobstrava (okrem stravy pocascestovania v siivislosti so sluzbamiposkytovanymi spolocnosti Schering)admini strati vne a/alebo rezijnenakladyprezentacie agentury za ucelomziskania noveho obchodudarceky pre zamestnancov Institiiciezabava pre zamestnancov Institiicieprirazky k akymkol'vek hotovymvydavkompohostenie pre osoby, ktore nesuvisiaani nie su spojene s pracouvykonavanou pre Schering.

Poznamka: V tomto zozname sii uvedene hlavnepolozky, ktore Schering nebude preplacaf Instituciiani Skusajucemu, azoznam je len nazorny a nie jekompletny. Vsetky naklady budii preskumanevzhradom na primeranosf takych vydavkov.

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EXHIBIT BPayment Schedule

Payments as detailed in Exhibit A will be madefollowing the end of each quarter. The time period forpayment will be 30 days and it shall commence on theday when a valid invoice compliant with applicable taxlaws of the Slovak Republic is delivered to Schering'sregistered seat.

The parties agree and confirm that the invoice shallhave requirements stipulated by Act No. 222/2004 Coll.on VAT, as amended, especially:

(i) the name and address of the registered seat,place of business, or establishment of a taxpayerwho supplies the goods or services, and his taxidentification number,

(ii) the name and address of the registered seat,place of business, establishment or permanentaddress of the recipient of goods or services andhis tax identification number, if any,

(iii) the sequential number of an invoice,(iv) the date of supply of goods or services, or the

date of receiving a payment, where this date canbe determined and is different from the invoiceissue date,

(v) the invoice issue date,(vi) the quantity and type of the goods supplied orthe extent and type of service rendered,(vii) the tax basis, the per unit price without the tax

and reductions and discounts if these are notincluded in the unit price,

(viii) the tax rate or indication of tax exemption,(ix) the tax amount in euros, which shall be paid.

Schering is obliged to mail written advice concerningthe payment of remuneration to the address:

Univerzitna nemocnica L. Pasteura, Kosice,Ekonomicky usek, Rastislavova 43, 041 90 Kosice,giving its official trade name, specific symbol of thepayment that is the same as Protocol number, variablesymbol of the payment (payment identification number)= Invoice No. and the notice for the receiver of thepayment (partial payment, total payment, balance, nameof Investigator).

PRJLOHA BPlan platieb

Platby, ako je podrobnejsie uvedene v Prilohe A, sauskutocnia po skonceni kazdeho stvrfroku. Dohasplatnosti je 30 dm a zacina plyniif odo dnadorucenia platnej faktury, ktora je v sulades platnymi danovymi pravnymi predpismiSlovenskej Republiky, do sfdla spolocnosti Schering.

Zmluvne strany sa dohodli a potvrdzuju, ze fakturaobsahovaf nalezitosti podl'a zakona c. 222/2004 Z.z.o dani z pridanej hodnoty, v zneni neskorsichpredpisov, a to najma:(i) meno a adresu sidla, miesta podnikania,

pripadne prevadzkarne platitel'a, ktorydodava tovar alebo sluzbu, a jehoidentifikacne cislo pre dan,

(ii) meno a adresu sfdla, miesta podnikania,pripadne prevadzkarne alebo bydliskaprijemcu tovaru alebo sluzby a jehoidentifikacne cislo pre dan, ak mu jepridelene,

(iii) poradove cislo faktury,(iv) datum, ked' bol tovar alebo sluzba dodana,

alebo datum, ked' bola platba prijata, aktento datum mozno urcit' a ak sa odlisuje oddatumu vyhotovenia faktury,

(v) datum vyhotovenia faktury,(vi) mnozstvo a druh dodaneho tovaru alebo

rozsah a druh dodanej sluzby,(vii) zaklad dane, jednotkovu cenu bez dane a

zl'avy a rabaty, ak nie su obsiahnutevjednotkovej cene,

(viii) uplatnenu sadzbu dane alebo udajo oslobodeni od dane,

(ix) vysku dane spolu v eurach, ktora sa mazaplatif.

Schering je povinny zaslaf o platbe odmenypisomne avizo na adresu:

Univerzitna nemocnica L. Pasteura Kosice,Ekonomicky usek, Rastislavova 43, 041 90 Kosice,s uvedenim presneho obchodneho mena zadavatel'a,specificky symbol platby, ktory je totozny s cislomprotokolu, variabilny symbol platby = cislo fakturya spravu pre prijfmateFa/ ciastocna uhrada, celkovauhrada, vyuctovanie, meno skusajuceho.

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