Textová podoba smlouvy Smlouva č. 4077084: Smlouva o zkoušejícím iniciované studii

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Investigator-Initiated Research Agreement Smlouva o zkousejicim iniciované studii

This Investigator—Initiated Research (“IIR”)

Agreement (“Agreement”) between
Tato smlouva (dale jen ,,smlouva”)

o zkousejicim iniciované studii (,,IIR”) je

uzavfena mezi

1. P zer, spol. s r.0., with an of ce of

business at Stroupeznického 17, 150 00

Praha 5 — Smichov, Czech Republic, ID

No. 49244809, VAT No. CZ49244809,

registered in the commercial register with

the Municipal Court in Prague, le no. C

228795 (“P zer”),

1. P zer, spol. s r.0., se sidlem na adrese

Stroupeznického 17, 150 00 Praha 5 —

Smichov, 16:: 49244809, DIC:
CZ49244809, zapsana V obchodnim

rej stfiku u Méstského soudu V Praze,

spis. zn. C 20616 (dale jen ,,spolecnost

P zer”), a

and

2. Fakultni nemocnice Hradec Kralové, se

sidlem na adrese Sokolska 581, 500 05
Hradec Kralové — Novy Hradec Kralové,

ID No.: 00179906, VAT No:

CZ001 79906CZ00179906, a directly
controlled organization of the Ministry of

Health of the Czech Republic

(“Institution”)

2. Fakultni nemocnice Hradec Kralové,

se sidlem na adrese Sokolska 581, 500
05 Hradec Kralové — Novy Hradec

Kralové, 1C: 00179906, DIC:
CZ00179906, pfimo fizena organizace
Ministerstva zdravotnictvi CR (dale jen

,,zdravotnické zah’zeni”).

Institution investigator—
-(“Principal Investigator”) has designed and

intends to conduct a laboratory study involving

the use of human biological samples (eg, cells,

cell cultures, blood, urine, tissue, saliva) provided

by Institution (“Biological Samples”). The

laboratory study is entitled “Response to
treatment in acromegaly correlated with

immunohistochemical somatostatin and dopamine

2 receptor expression pro le,” P zer Tracking
Number WII229983, (“Study”). P zer wishes to

provide certain support for the Study.

Zkouse'ici zdravotnického za ’zeni_
—(dale jen ,,hlavni zkousejici“)
navrhl a ma v umyslu provest laboratorni studii

tykajici se pouziti lidskych biologickych vzork

(napr. bunék, bunéénych kultur, krve, moci,

tkané nebo slin) poskytnutych zdravotnickym

zafizenim (dale jen ,,biologické vzorky”). Nazev

laboratorni studie je ,, Response to treatment in

acromegaly correlated with
immunohistochemical somatostatin and

dopamine 2 receptor expression pro le “,

registracni cislo spolecnosti P zer W11229983,

(dale jen ,,studie). Spoleénost P zer poskytne

k realizaci této studie urcitou podporu.

Accordingly, the parties agree as follows: V souladu s timto uzaviraji smluvni strany

nasledujici smlouvu:

1. Investigators and Research Staff 1. Zkouseiici a vvzkumnv personal



1.1. Principal Investigator. Institution 1.1 Hlavni zkousejici.

shall ensure that the Study will be ZdraVotnické zafizeni se zavazuje
conducted by Principal

zajistit, ze studii provede hlavm’

Investigator who is an employee Zkougeji ia kteryje zamésmancem

of the Institution.
zdravotmckého zarizeni.

1.2. Obligations. Institution is 1.2 Povinnosti. Zdravotnické

responsible to P zer for and shall za zeni OdPOVidiil SP0165n05ti P zer
ensure compliance by all za to a zavazuje se zajistit, ze

personnel who participate in the veékim': Rer§°né1 PQdileliCi e na

conduct of the Study, including provadenl tetOVStP’ vcetne
the Principal Investigator and any

hlavmho
zkousejiciho

a
vsesh

. dodavatelu nebo konzultantu, bude
contractors or consultants, w1th dodriovat podminky této smlouvy
the terms of th1s Agreement.

2. Protocol 2. Protokol

2.1. Protocol. The Study will be 2.1 Protokol. Studie bude

conducted in accordance with a provedena v souladu s protokolem

protocol developed by Principal 56 StaVenS'm hlaVDim ZkOU§ejiCim
Investigator (“Protocol”). P zer (dale jen ”PmtOkOI”) Aby “101113
approval of the nal Protocol is a SP0165HOS‘E P zer poskytnout

condition of P zer support under pOdPOYu V,S9UIadu§ touto smlouvou,
this Agreement.

mu51 schval1t konecny protokol.

2.2. Amendments. IfPrincipal 2.2 Dodatky. Jestlize hlavni

Investigator modi es the P zer- zk0u§ejici provede upravy
approved nal Protocol, Principal

v konecném protokolu schvaleném

Investigator will promptly inform spolevéwfi Pfizer, bUde hlaYni
P zer in writing. Continued ZkOllSCJICIVO t’eto skuteénostl

support by P zer will be neprodlene
p1semne 1nformovat

. , . spolecnost P zer. Spolecnost P zercontingent on P zer s rev1ew and bude nadale poskytovat podporu,
acceptance of the Protocol

pouze pokud zkontroluje a
changes. odsouhlasi zmény v protokolu.

3. Study Conduct 3. Provadéni studie

3.1. Sponsorship. Institution, not 3.1 Zadavatel. Zadavatelem

P zer, is the sponsor of the vyzkumné Studie je Zdravotnické

Study.
Institution will not zaf’izeni, nikoli spolecnost P zer.

represent to any third party, 2dravotnické zavrizeni ncsmi sdelovat
including the donors of the Zédne treti Strane, vcetne

darcu
, .

Biological Samples (“Sample b1olog1ckych
vzorku (dale Jen.,,d.ar01

Donors”) that P zer is a sponsor. vzorkn )’
Z6 zadavatelem Studle Je

spolecnost P zer.

3.2. Regulatog. Institution is solely 3.2 Regulatomi pozadavg.

responsible for any and all safety

reporting and regulatory
obligations associated with the

conduct of the Study.

Zdravotnické zarizeni nese vyhradni

odpovédnost za predkladani vsech

zprav o bezpecnosti a plneni
regulatomich povinnosti



souvisejicich s provadénim studie.

3.3. Standards. Principal Investigator 3.3 Standardy. Hlavni zkousejici
will conduct the Study in bude studii provadét V souladu

accordance with the Protocol, 5 Pr9t0k016mt smémiCi 0 SPféVné
International Conference on kllmcke' prax1 vydanou Mezinérodni

Harmonization Good Clinical
konferenci pro

harmonizaci
(ICH

Practice (ICH GCP) guidelines GCP) (V rozsahu pouzitelnem pro

(to the extent applicable to this tento druh §t121d1.6) aI§{ISlu,Snimc ., ,

type of study), and all applicable ELZZmIElliFre £133?- ta-Zum-Z (31189101

law. Principal Investigator will v
p ves

ere
ms 1 elona m

pozadavky a pozadavky

comply With all institutional and Institucionalni hodnotici komise
Institutional Review Board (IRB) (IRB) nebo Nezavislé etické komise
or Independent Ethics Committee (IEC) tykajici se studii zahrnujicich
(IEC) requirements relating to pouiiti lidskych biologickych

studies involving the use of Vzork -

human biological specimens.

3.4. IRB/IEC Approval. If required 3.4 Schvaleni ze strany IRB/IEC.
for this type of study, Principal Je—li to nutné pro tento druh studie,

Investigator will ensure that the 111a ZkOU§ejiCi zajisti, aby Stfldie

Study is approved by and subject
byla schvalena

prislusnou
kormsi

to continuing oversight by an IRBc a podlehala Jéjlmvu ,
appropriate IRB/IEC. If IRB/IEC mal?mu,d0hkid,u'

Je‘h
Vyzgdovano

approval is required, Institution SChvaleni kqmscl,IRB/IEC’ Je
, _ zdravotnlcke zanzenl pov1nno, za

must, as a conditlon of P zer ucelem splnéni podminky pro
support, proVIde P zer Wlth _ _ podporu ze strany spolecnosti P zer,
documentatlon of both the 1mt1al pfedloiit spoleénosti P zer

IRB/IEC approval of the nal dokumentaci ohledne pocatecniho
Protocol and annual renewals of souhlasu s konecnym protokolem

that approval if such renewals are udéleného komiscmi IRB/IEC a

required (see
Attachment B,

kazdorocniho prodlouzeni tohoto

Study
Documentation

souhlasu,
pokud je

toto
prodlouieni

Requirements). Institution will VyzvadOVéno (VIZ P k’ha Bf .
notify P zer promptly of any

Pozadavky
na dohumentam

studle).

withdrawal or suspension of Zdravomlgke
zanzem Je po

dObu

IRB/IEC approval during the term platnostl tStF’ smlouvy pov1nno
_ neprodlene 1nformovat spolecnost

Of th1s Agreement. P zer, jestlize komise IRB/IEC

odebere nebo pozastavi souhlas.

35- W- This 3-5 W-Tato
laboratory Study will involve use
of Biological Samples provided

by Institution.

laboratorni studie bude zahrnovat

pouziti biologickych vzork1°1

poskytnutych zdravotnickym

zarizenim.

Consent. Principal Investigator

will (a) obtain informed

consent from individuals from

whom Biological Samples were
obtained (“Sample Donors”) in

accordance with applicable

Souhlas. Hlavni zkousej ici j e

povinen
a) ziskat informovany souhlas

osob, od nichz byly ziskany

biologické vzorky (,,darci

vzork “) podle prislusnych



law, (b) ensure that informed

consent that covers the research

to be conducted has already

been obtained, or (c) obtain a

waiver of informed consent for

the use of the Biological

Samples in the Study from an

appropriate IRB/IEC. Principal

Investigator will also ensure

compliance with applicable
privacy laws in regard to the

use and disclosure of health

information relating to the

Sample Donors. If an informed

consent is used, Principal

Investigator will inform Sample

Donors that P zer is providing

support for the Study. P zer

has no obligation to participate

in the development of, or to

review or comment on, an

informed consent document or

waiver request.

pravnich predpis ,

b) zajistit informovany souhlas
ohledné vyzkumu, ktery ma byt

provadén,

c) zajistit prohlaseni o zreknuti se
prava na informovany souhlas

k pouziti biologickych vzork ve

studii od prislusné komise
IRB/IEC. Hlavni zkousejici je

dale povinen zajistit dodriovani

pf'i slusnych pravnich predpis na

ochranu osobnich udaj 1°1

souvisejicich s pouzitim a

poskytovanim zdravotnich udaj

o darcich vzork . V pripadé

pouziti informovaného souhlasu

je hlavni zkousejici povinen
informovat darce vzork 0 tom,

ze spoleénost P zer poskytuje

podporu k provadéni studie.

Spoleénost P zer neni povinna

podilet se na vytvareni, kontrole

nebo pripominkovani dokurnentu
pro poskytovani informovaného

souhlasu nebo zadosti o zreknuti

se prava.

Ownership and Disposition.

P zer makes no claim of

ownership to Biological

Samples provided for the Study

by Institution. Institution is

responsible for appropriate

disposition of all remaining

Biological Samples at the end

of the Study.

Vlastnické pravo a likvidace.

Spoleénost P zer neuplatnuje

zadné naroky na vlastnictvi
biologickych vzork

poskytnutych zdravotnickym

zaii'zenim pro 1'16e studie.
Zdravotnické zaii'zeni po

skonéeni studie odpovida za

vhodnou likvidaci vsech

zbyvajicich biologickych vzork .



3.6. No Monitoring or Data 3.6 Provadeni monitoringu nebo

Collection. P zer will not W.Spoleénost
monitor the

Study or
receive

any
P zer nebude provadét monitoring

Study Data (as de ned in Section Studie; ani pf’ijimat zédna studijni
5, Study Data and Study Results). Qata akje stanoveno V Clank? 5

_

Udaje o stud11 a vysledky stud1e).

3.7. Duration of Study Conduct. 3.7 Doba trvani studie. Hlavni

Principal Investigator expects to ZkOll§ejiCi liedlmkléldél dOkOHéeni

complete Study
conduct studie (dokonceni postup V ramci

(completion of the Study studie avcasti’st'udie vénované v , o
procedures and data collection Shromagdbvam udaju) do 12 meme“

portion of the Study) within 12
0d pwm platby.

months of the rst payment.

3.8. Status Updates. Principal 3.8 Aktualizace stavu studie. Po

Investigator will provide P zer dObu PlatDOSti féto SHIIOUVYJC hlaVni
with an update of Study status, in 21‘0“n iCi POVmen POSIfytfl?“t_
the form requested by P zer, at SPOICCHOSU P zer aktunlni ndaje ,
least once a year during the term 0 Stavvu Stufhe V podobe vyzadfmfne
of this Agreement, or more spolecnosti lf zfr’

a
t? nnnirnalne

frequently if so indicated in Jednou-rocne’ pnpadne caste]
1’

pokud Je takto uvedeno v pnloze A
Attachment A (Payment (Rozvrh plateb) nebo pokud se na
Schedule) or Ifmutually agreed tom strany vzaj emné dohodnou.
by the parties. Each status update Aktuélni daje o stavu provédénj

will include Study progress, studie budou obsahovat informace
publication plans, any 0 pr béhu studie, plany publikaci,

adjustments in estimated Study zmény PfedPOklédanéhO data
conduct completion date,

and
any

dokonceni studie a dalsi informace,

other information reasonably ktefé Slwm ze 53016613?“ P zer

requested by P zer.
v pnmerene nnre vyzadat.

4. Investigator-Initiated Research 4. Podpora Zk0u§eiicim iniciovaného

Support. yy'zkumu

P zer will provide funding in support of the

Study in the amount of 34 192, 42 Eur, in

accordance with the schedule in Attachment A,

Payment Schedule. This funding constitutes the

Investigator—Initiated Research Support for this
Study.

Spoleénost P zer poskytne nanéni prostredky

na podporu studie ve vysi 34 192, 42 Eur

v souladu s rozvrhem plateb uvedenym v p 'loze

A — Rozvrh plateb. Tyto nancni prostredky

predstavuj i podporu poskytnutou pro realizaci

této zkousejicim iniciované studie.

The funding referred to in the previous paragraph
will be provided for the Institution via a non—cash

payment made to the following bank account:

Finanéni prostredky dle predchoziho odstavce
budou zdravotnickému zafizeni poskytnuty

bezhotovostni platbou na bankovni ucet:

Bank: Ceska narodm' banka banka: Ceska narodni banka

Bank Address: Na P kope 28, 115 03 Praha 1 adresa banky: Na Prikope 28, 115 03 Praha 1



Bank Account N0.: 34534— c. uétu: 34534—2463951 1/0710

24639511/0710

IBAN: IBAN: CZ9307 10034534002463 95 1 l

CZ930710034534002463951 l

SWIFT: CNBACZPP SWIFT: CNBACZPP

Payment reference N0.: 6100 Variabilni symbol: 6100

The funding will be provided to the Institution

against the invoices (tax documents) issued by the
Institution for P zer.

The Institution shall issue the invoices in

accordance with the Payment Plan speci ed in
Annex hereto.

Financni prostredky budou zdravotnickému

zarizeni poskytnuty na zakladé faktur —

danovych doklad , které zdravotnické zarizeni

vystavi spolecnosti P zer. Faktury musi byt

zdravotnickym za 'zenim vystavovany v souladu
s rozvrhem plateb v priloze A této smlouvy.



4.1. Basis of Support. This IIR 4.1 Podming pro poskmuti

Support is not conditioned on any podponl- Tato podpora 2k0u§ejicim

pre—existing or
future business iniciované studie neni podminena

relationship between P zer and iédnj’m PfedChOZim Deb? bUdOHCim

either the Principal Investigator or Obehcidmn,‘ VZtahem men,
the Institution. It is also not 81,016“???

1 P zer a
mam.“

. . . zkousej 101m nebo zdravotmckym

condltioned
on

any blismFss
01‘

zaf’izenim. Dale neni podminena
other decrslons the Pr1nc1pal

zadnymi obchodnimi éi jinymi
Investigator or Institution has rozhodnutimi hlavniho zkousejiciho

made, 01' may make, relating to nebo zdravotnického zafizeni, ktera
P zer or P zer products. mohou nebo mohla byt vydana

V souvislosti se spoleénosti P zer

nebo jejimi produkty.

4.2. Submission of Required 4.2 Predkladani pozadovany’ch
Documents, P zer will not dokument . Spolecnost P zer

provide any component of the IIR 1161305194116 iédnou éés‘i POdPOFY

Support
until P zer has received

zkousejvi’cimviniciované
studie, dokud

the required documents identi ed neowrz} pozadovane dOktlmenty
in Attachment B, Study

uvedene V Pnloze. B — Pozadavlq na

Documentation Requirements.
dOkumentaCI Studle'

4.3. Use of IIR Support. The 4.3 Pouziti podporv zkouseiicim
Principal Investigator and iniciované studie. Hlavni zkousejici

Institution will use IIR Support a df ‘VOtniCkév zarizenijsou PQVinIli
solely for purposes of the Study. vyu21vat Prostfeflky peskytnute’na
At the completion of the Study, pOdPorqousgj 101m, rn1c1ovane
Principal Investigator will studleyyhradne pro ucely studie.

con rm in writing that the IIR €113,111 kousecjm tpoddolfoncems 1e 1semne o vr 1, ze
Support has been used only t9 prostfeldky posklytnuté na podporu
SUPP“t the Study by completlng zkousejicim iniciované studie byly
a Certi cate of Study Completion pouzity Vyhradné k uéel m

form provided by P zer. provedeni studie, a to vyplném’m
formulaic Potvrzeni 0 dokonéem'

studie vydaného spolecnosti P zer.

4.4. Study Budget. Study Budget. 4.4 Rozpoéet studie. Rozpocet

Institution represents that the

Institution-provided Study budget

upon which the IIR Support is

based re ects an informed

estimate of all funds required to

complete the Study.

studie. Zdravotnické zarizeni

prohlasuje, Ze jim pfedkladany

rozpocet studie, na zakladé nehoz

jsou uréeny prostfedky na podporu
zkousejicim iniciované studie,

vychazi z kvali kovaného odhadu

veskerych prostfedk potfebnych

k provedeni studie.



4.5. Disclosure by P zer. In the

interest of transparency relating to

its nancial relationships with

investigators and study sites or to

ensure compliance with

applicable local law, P zer may

publicly disclose the support it

provides under this Agreement.
Such a disclosure by P zer may

identify both the Institution and
the Principal Investigator, but will

clearly differentiate between

payments or other transfers of

value to institutions and those

made to individuals.

4.5 Uverejneni informaci

spoleénosti P zer. Za uéelem
transparentnosti nanénich vztah1°1 se

svymi investory a vyzkumnymi

pracovisti nebo za uéelem zajisteni

splnéni poiadavk stanovenych

pi'i slusnymi rnistnimi pravnimi

predpisy je spolecnost P zer

opravnéna uverejnit podporu studie,

kterou poskytuj e podle této smlouvy.

Spoleénost P zer m ze v ramci

tohoto zverejnéni oznaéit

Zdravotnické zaii'zeni i hlavniho

zkousejiciho, avsak zretelné pritom

odlisi platby nebo j iné prevody

nanénich prostredk provadéné ve

prospéch Zdravotnickych zarizeni od

plateb, které provadi ve prospech

fyzickych osob.

5. Study Data and Study Results 5. Data ze studie a vvsledkv studie

For purposes of this Agreement, “Study Data”

means the raw, non—aggregated data collected

during the course of the Study. “Study Results”

refers to aggregated or summarized Study Data

and conclusions about the Study, as would be

included in a study report or publication.

Principal Investigator is free to publish the Study

Results, subject to the provisions in Section 7

(Publications) and Principal Investigator and

Institution are free to use Study Results for any
other purpose. Institution owns and is free to use

the Study Data for its own research, educational,

and patient care purposes and programs.

However, in consideration of the P zer IIR

Support, Principal Investigator and Institution

will not use or permit others to use the Study Data

for the commercial bene t ofany third party.

Pojem ,,data ze studie” oznaéuje pro (16e této

smlouvy neupravena, nesouhrnna data

shromazdéna v pr béhu studie. Pojem ,,vysledky

studie” se vztahuje na souhrnna nebo

sumarizovana data ze studie a zavéry uéinéné o

studii v podobé, v niz budou zahmuty do zpravy

o studii nebo pri publikovani. Hlavni zkousejici

je opravnén publikovat vysledky studie ve

smyslu ustanoveni clanku 7 (Publikace) a m ie

je spolu se Zdravotnickym zafizenim pouzit

k jakymkoliv jinym uéel m. Zdravotnické

zarizeni je vlastnikem dat ze studie a smi je

pouiivat pro uéely vlastniho vyzkumu,

vzdelavani, péée o pacienty a programy.

S ohledem na podporu spolecnosti P zer

poskytnutou této zkousejicim iniciované studii

Vsak nej sou hlavni zkousejici a Zdravotnické

zarizeni opravnéni pouzivat data ze studie a
udaje o studii ve prospech treti strany, ani takové

pouziti dat umoznit

6. Study Report 611%
. Within six months after completion of Study

conduct or termination of this Agreement,
whichever occurs rst, Principal Investigator will

provide P zer with a written report of the Study

Results (“Study Report”). Unless otherwise
agreed in writing by the parties, the Study Report

may take the form of a manuscript for publication

(see Section 7, Publications). Ifthe Agreement is

terminated early, the Study Report should

include, at minimum, the results of the Study up

until the date of termination.

Do sesti mésic od data ukonéeni studie nebo

ukonéeni platnosti této smlouvy, podle toho,
ktera z uvedenych okolnosti nastane dii’ve,

predlozi hlavni zkousejici spolecnosti P zer

pisemnou zpravu o vysledcich studie (,,zprava

o studii”). Neni-li smluvnirni stranami pisemné

stanoveno j inak, m ie byt zprava o studii

sestavena v podobé rukopisu k publikaci (viz

clanek 7 — Publikace). V pripadé predéasného

vypovezeni smlouvy bude zprava o studii
zahmovat minimalné vysledky studie dosazené



do data ukonéeni/vypovézeni smlouvy.

7. Publications 7. Publikace

P zer supports the exercise of academic freedom

and encourages Institution to publish the Study

Results, Whether or not they are favorable to

P zer or any P zer product. As used in this

Agreement, “Publication” means any journal

article, abstract, presentation, or other type of

public disclosure that reports any Study Results.

Spoleénost P zer podporuje akademické

svobody a uznava pravo zdravotnického zarizeni

publikovat vysledky studie, a to bez ohledu na

skuteénost, zda jsou, éi nej sou tyto vysledky

priznivé pro produkt spoleénosti P zer. Pojmem

,,publikace” se pro 1'16e této smlouvy rozumi

jakykoliv novinovy clanek, abstrakt, prezentace

nebo jiny zp sob zvefejném’ infonnaci tykajicich

se vysledk studie.

7.1. Pre—Publication Review. 7.1 mm.

Principal Investigator or other HlaVDi Zk011§ej
i:

neboj
i1; smém’appropriate Institution authors aUtO V rémCi Z raVOtnic é 0

(“Authors”) will provide P zer an
zafilzfni ($11;m ,,(autoti”?lumg(zv)nio ortuni a minimum of 60 spo ecnos 1 1261‘ n’llnll’na ne

digs befoi: gubmission or other (In? p
fed

odevzdanim
nebo

mm .

public disclosure) to
zpusobem uverejnen1)prostudovat s1

. . Jakoukollv navrhovanou publlkac1.
prospectively

rev1ew
any

. Spoleénost P zer provede posouzeni
proposed Publlcatlon. P zer Wlll a m Ze komentovat obsah. Autori
rev1ew and may prov1de posoudi veskeré komentare v dobré
comments on content. Authors vife, nejsou vsak povinni prijmout
will consider any such comments jakékoliv navrhy spolecnosti P zer.
in good faith but are under no

obligation to incorporate any

P zer suggestions.

7.2. Standards. For all Publications, 7.2 StLdardy. U vsech publikaci

Authors will comply with the jSOU autofi POVimlj dodrzovat
authorship guidelines in the autorské P9k3fny uvedené , V ,
Recommendationsfor the V D0p07urce,nlchrpr0[Wot/5161:6711,
Conduct, Reporting, Editing, and sestizvovani zprav, redakcnz upravy

a

Publication ofScholarly Work in uverejnovani dgmilCh praci
Medical Journals

v odbornych .lekcirskycn casopzsech

, _ , . (http://WWWJce.org/lcmle-
(httDI//www.1cm1e.org/10ml e-. recommendationspdf) sestavenych
recommendatlonspdf) establlshed Mezinérodnim Vyborem redaktor
by the International Committee of lékafskych éasopis .
Medical Journal Editors.

7.3. Disclosure of Support. Authors 7.3 M

will disclose P zer support of the

Study in any Publication.

0 podpofe. Autofi ve vsech
publikacich uvedou, ze spoleénost

P zer poskytla podporu

k vypracovani studie.



8. Termination Ukonéeni smlouyy

8.1. Termination Events. Termination 8.1 Okolnosti ukonéeni smlouvv.

of this Agreement will be

triggered by the earlier of any of

the following events.

Tato smlouva bude ukonéena

V pfi’padé nékteré Z nasledujicich
Okolnosti, podle toho, ktera z nich

nastane drive.



a. Completion of Agreement

Obligations. The Agreement

will terminate when the Study

is completed, which means the

completion of all Protocol-

required activities (“Study

Completion”), and the parties

have received all deliverables
and payments owed.

Splnéni smluvnich povinnosti.

Smlouva bude ukonéena k datu
dokonceni studie, to znamena

poté, co budou provedeny

veskeré cinnosti stanovené

protokolem (,,provedeni studie”),

a poté, co vsechny smluvni strany

obdrzi veskeré vystupy a splatné

platby.

Early Termination by

Institution. If Institution

terminates the Study early, for

any reason, Institution may

terminate the Agreement upon

notice to Pfizer.

Predcasné vvpovézeni smlouVV
ze strany zdravotnického zafizeni.

Zdravotnické za 'zeni m ie

z jakéhokoliv d vodu nebo i bez

udani d vodu smlouvu predcasné

ukonéit na zakladé pisemné

vypovédi zaslané spoleénosti
P zer.

Early Termination by P zer.

P zer may terminate the

Agreement early in any of the
following circumstances:

Predcasné vvpovézeni smlouVV

spoleénosti P zer. Spoleénost
P zer m ie pfedéasné ukonéit

smlouvu kdykoliv V nasledujicich

p padech;

1) The Protocol is modi ed

in a way unacceptable to

P zer (see Section 2.2,

1) Doslo ke zméné

protokolu zp sobem, ktery

je pro spoleénost P zer

Amendments).
nep jatelny (viz clanek 2.2
— Dodatky).

2) Study conduct is not 2) Studie nebyla

completed within six

months after the target

date (see Section 3.7,

Duration of Study

Conduct).

dokonéena do sesti mésic

od stanoveného data
dokonéeni (viz clanek 3.7
— Doba trvani studie).

3) The Study does not start

within six months of the

3) Studie nebyla

zahaj ena do sesti mésic

Effective Date of this Ofl data nabyti I'léinnosti

Agreement. teto smlouvy.

4) Study progress is 4) Pri’ibéh studie je

signi cantly slower than

that outlined in the

Protocol or proposal or

needed to complete the

Study by the target date.

znacné pomalej si, nez je
stanoveno protokolem ci

navrhem nebo nez je

potreba k dokonceni studie
ke stanovenému datu.

5) The Study design or

objectives are no longer

scienti cally relevant.

5) Koncepce

studie nebo jej i cile jiz

nej sou z védeckého

hlediska relevantni.

10



(1. Termination for Cause. Either

party may terminate the

Agreement immediately upon

noti cation for cause, including

but not limited to uncured

material breach of the terms of

this Agreement by the other

party. Also considered

adequate cause under this
provision would be failure by

Institution to comply with, or a

demonstrated intent to fail to

comply with, the warranties in

Section 11 (Anti-Corruption).

Odstoupeni od smlouvv z d1°1vodu

zavainého poruseni zavazk .

Kterakoliv ze smluvnich stran je

opravnéna odstoupit od smlouvy

ihned po oznameni d vodu

odstoupeni, napf‘iklad z d vodu

zavainého poruseni této smlouvy

druhou smluvni stranou bez

napravy. Dalsim d vodem, ktery

je povaiovan za opravnény ve

smyslu tohoto ustanoveni, je

nesplneni zaruk nebo projev
umyslu zéruky nesplnit podle

clanku ll (Antikorupéni

ustanoveni).

8.2. Effective Date of Termination. If

the termination of the contract

occurs because of the

circumstances stated in Article

8.1.b or c, the termination /

termination of the contract shall

become effective upon the

expiration of a notice period of 2

months commencing on the rst

day of the month following the

delivery of the termination to the
other party.

8.2 Datum uéinnosti ukonéeni

smlouvy. Pokud k ukonéeni smlouvy

doslo Z d vodu okolnosti uvedenych

v clancich 8.1.b nebo c,

ukonéeni/vypovéd’ smlouvy nabyva

uéinnosti uplynutim vypovédni doby

v délce 2 mésic , ktera poéne beiet

prvnim dnem mésice nasledujiciho

po doruéeni ukonéeni/vypovédi

druhé strané.

11



8.3. Payment upon Early Termination.

The terms in this Section 8.3,

Payment upon Early Termination,

apply only if the Agreement is

terminated early for a reason

other than for cause (see Section
8.1.d, Termination for Cause).

Upon early termination, P zer

will pay a pro rata portion of the

total IIR funding, less payments

already made. Institution will

refund to P zer any funding

already received in excess of this

calculated amount except to the

extent that such funds have

already been used, or committed

and unable to be canceled, in a

manner consistent with the Study
budget upon which the IIR

Support is based or as

prospectively approved by P zer.

8.3 Platba po predéasném

movézeni smlouvy. Podminky

uvedené v clanku 8.3 — Platba pfi

predéasném ukonceni smlouvy se

uplatni pouze v p padé predcasného

ukonéeni smlouvy z d vod

nepfedstavujicich zavaZné poruseni

zavazk (viz clanek 8.1.d —

Odstoupeni 0d smlouvy z d vodu

zévainého poruseni zavazk ).

V p padé predcasného ukonceni

smlouvy uhradi spolecnost P zer

pomérnou cast celkové castky
nanéni podpory na zkousejicim

iniciovany vyzkum p0 odecteni jiz

uhrazenych plateb. Zdravotnické

zarizeni vrati spolecnosti P zer

veskeré prostredky, které jiz prij alo a

jejichz vyse pfesahuje tuto
vypoétenou castku, kromé p 'padu,

kdy tyto prostredky jiz byly pouiity

nebo poukazany a tuto uhradu jiz
neni mozné zrusit, a to zp sobem

odpovidajicim rozpoctu studie, na

némz je zaloZena nanéni podpora

akademického vyzkumu nebo

zp sobem v budoucnu schvalenym

spoleénosti P zer.

12



8.4. Reconciliation upon Study 8.4 V ovnani po provedeni

Completion. At Study m. Po dokonéeni studie si

Completion, the parties will $111111“? strany poskytnouw
cooperate to perform a nancial Od’VldaJ 101 soucjnPOSt P“ , ,
reconciliation to con rm

vzajemnem nancnim vyrovnanl pro

. potvrzeni souladu mezi celkovymi
cons1stency between total P zer . , , . . , .

. nnlnlkovyrm platbami uhrazenyrm
mllestone

payments
and the

spoleénosti P zer a smluvné
agreed-upon mllestones and

stanovenymi milniky a vystupy.
dellverables. The partles agree to Smluvni strany se zavazuji vzaj emné
make any adjustment (eg, refund si vyrovnat pripadné rozdily (napf.
or additional payment) that is vracenim navic uhrazené eastky
revealed by this analysis to be nebo doplacenim formou dodateéné
warranted. platby), zjisténé provedenou a

overenou analyzou

9. Other Provisions 9. Ostatni ustanoveni

9.1. Indemni cation. The Study is not 9.1 Odskodneni. Tato studie neni

designed, Sponsored, or managed navrhovana, zadavana ani fizena

by P zer and P zer provides no
spoleénosti P zer, ktera zaroven

indemni cation of any type.
neposkytuje zadné odskodneni.

9.2. Suitability. Institution certi es 9.2 Soulad se zakonem.
that both it and Principal Zdrayotnické zafizeni prohlasuje, ze

Investigator are licensed, jsou SPOIU S hlavnim Zk9U§ejif3ifn
registered, or otherwise quali ed drzlteh odpowdajicich 11361101, J50“
and suitable under local laws to r glsuovam a 521mm dab , , ,
act as a clinical study sponsor predpoklady p99‘1”“?p”V131“? ,

. . . ’ predplsy platnynn v zenn provadem

Stud? Slte’
or

Investigator,
as studie, na zaklade kterych jsou

applicable. Inst1tutlon also
opravneni vykonavat cinnost

certl es that there are no zadavatele, vyzkumného pracoviste
applicable laws or other nebo zkousejicich. Zdrayotnické
obligations that prohibit it from zafizeni dale prohlasuje, 2e
conducting the Study and entering neexistuji pravni ani jiné prekazky,

into this Agreement. Institution které by mu bramly V PFOVedeni
further certi es that neither it nor Studie a aza‘ffenifetOISH OUVy-I V
Principal Investigator is debarred .ZdraVOtFICke Zanzem prvohlasuje, 26

under subsections 306(a) or and Jergulamcnlavnilmuzl11t10h0du me21 smluvnimi
understanding between the parties

Stranaml V sow/15108“ S predmetem
. . . smlouvy. Tato smlouva nahrazuje

relatlng to this sub] ect matter. veskeré d véjsi dohody mezi
ThisAgreement supersedes all smluvnimi stranami (ustni i pisemné)
prev1ous agreements between the V souvislosti s touto studii

parties (oral1 and written) relating s vyjimkou zavazk , které ze své
to this Study, except for any podstaty z stavaji v platnosti
obligations that, by their terms, nezavisle na této smlouvé.

survive independent of this
Agreement.

9.9. Con ict with Attachments or 9.9 Rozpor mezi smlouvou a

Protocol. If there is any con ict

between this Agreement and any

VI
pnlohami nebo protokolem.

V pfipadé rozporu mezi touto

15



of its Attachments, the terms of

this Agreement will control. If

there is any con ict between the
Agreement and the Protocol, the

Agreement will control except

with respect to medical, scienti c,
or clinical matters relating to

Study conduct, for which the
Protocol will take precedence.

smlouvou a nékterou z jejich p ’loh

maji prednost ustanoveni této
smlouvy. V pripadé rozporu mezi

touto smlouvou a protokolem maji

prednost ustanoveni této smlouvy

s vyjimkou rozpor z hlediska

lékarského, Védeckého nebo

klinického, u nichi ma prednost

protokol.

10. Anti-Corruption 10. Antikorupéni ustanoveni

10.1. De nitions 10.1 De nice.

a. Government. As used in this
Agreement, “Government”

includes all levels and

subdivisions of governments
(ie, local, regional, and

national; administrative,
legislative, and executive).

Statni organy. Pojem ,,statni

organy” pro 1'16e této smlouvy

zahrnuje organy statni spravy a

samospravy na vsech urovnich

(tj. mistni, regionalni a

vnitrostatni; spravni, zakonodamé

a vykonné).

b. Government Of cial. As used

in this Agreement,

“Government Of cial”
includes
1) any elected or

appointed non—US

Government of cial (eg, a

legislator or a member of a

non—US Government

ministry),

2) any employee or

individual acting for or on

behalf of a non—US

Government of cial, non-

US Government agency, or

enterprise performing a

function of, or owned or

controlled by, a non—US

Government (eg, a

healthcare professional

employed by a non—US

Government hospital or

researcher employed by a

non—US Government

university),

3) any non—US

political party of cer,

candidate for non—US public

of ce, or employee or

individual acting for or on

Statni urednik. Pojmem ,,statni

urednik” se pro 1'16e této

smlouvy rozumi

1) zvoleny nebo

jmenovany

neamericky statni

urednik (napr. clen

zakonodarného sboru

nebo neamerického

statniho ministerstva),

2) zaméstnanec nebo
osoba vykonavajici

cinnost pro (nebo
jménem dale

uvedenych osob)

neamerického statniho

urednika,

neamerickou statni

agenturu nebo

spolecnost, ktera plni

funkci nebo je fizena
jinou nei americkou

Vladou (napr.

odbornik v oblasti

zdravotnictvi

zaméstnany

neamerickou statni

nemocnici nebo

16



behalf of a non—US political

party or candidate for public
of ce,

4) any employee or

individual acting for or on

behalf of a public

international organization,

and

5) any member of a

royal family or member of a

non-US military.

vyzkumny pracovnik

zaméstnany

neamerickou statni

univerzitou),

3) clen politické strany

mimo USA, kandidat

na funkci

V neamerickém
statnim uradu nebo

zaméstnanec ci
fyzicka osoba

vykonavajici cinnost

pro neamerickou

politickou stranu nebo

jednajici jejim

jménem nebo

kandidat na vefejnou

funkci,
4) zaméstnanec ci

fyzicka osoba

vykonavajici cinnost

pro vefejnou
mezinarodni

organizaci nebo

jednajici jejim

jménem,

5) clen kralovské rodiny

nebo clen neamerické

armady.

10.2. Warranties. Institution warrants 10.2 zaruky. Zdravotnické

to P zer the following: zaf’izeni ruéi spolecnosti P zer za

nasledujici:

a. Any information provided by

Institution to P zer as part of

P zer’s anti-corruption due

diligence process is complete
and accurate.

a. Veskeré informace poskytnuté

zdravotnickym zafizenim

spoleénosti P zer jako soucast

provadéni antikorupcni proverky

ze strany spoleénosti P zer jsou

uplné a pfesné.

The funding provided by P zer

under this Agreement will not

cause Institution or individuals

af liated with Institution to do
anything that would result in

P zer improperly obtaining or

retaining business or gaining

any improper business

advantage.

b. Financni' prostredky poskytnuté

spoleénosti P zer v souladu

s touto smlouvou nezpusobi, Ze

zdravotnické zaiizeni nebo osoby

s nim spojené uéini cokoliv,

v d sledku cehoz by spoleénost

P zer neopravnéne ziskala nebo

si udrzela zakazku, pripadné

ziskala jakoukoliv neopravnénou

obchodni vyhodu.

17



C. Institution will not, and will

take measures to ensure that

individuals af liated with
Institution will not, use any

portion of the P zer funding to

directly or indirectly offer or

pay any money or anything of

value in an effort to in uence
any Government Of cial or

any other person in order for

Zdravotnické za 'zeni nepouzij e

(a zajisti, aby nepouzily ani zadné

osoby, které jsou s nim

propojeny) 251a east

nanénich prostfedk

poskytnutych spoleénosti P zer

k prime éi neprimé nabidce ani

k poskytnuti jakékoliv nanéni

castky éi jiné hodnoty k pokusu

o ovlivnéni statniho urednika éi

jiné osoby s cilem

1) P zer to improperly

obtain or retain business

or to gain an improper

business advantage, or

1) zajistit

spoleénosti P zer

neopravnéné ziskani nebo

udrzeni zakazky nebo
ziskani neopravnéné

obchodni vyhody, nebo

2) Institution or the af liated
individual(s) to

improperly obtain or

retain business or gain a

business advantage.

2) aby

zdravotnické zafizeni nebo

osoby, které jsou s nim

propojeny, neopravnéné
ziskaly nebo si udrzely

zakazku, pripadné ziskaly

neopravnénou obchodni

vyhodu.

(1. Neither Institution nor, to

Institution’s knowledge, any

individuals associated with

Institution have accepted a
payment intended to
improperly obtain or retain

business for P zer or to gain an

improper business advantage
for P zer.

Zdravotnické za 'zeni ani osoby,

které jsou s nim propojeny,
nepf’ij aly s védomi'm tohoto

za ’zeni zadnou castku s umyslem

ziskat nebo udrzet zakazku pro

spolecnost P zer nebo ziskat pro

spolecnost P zer neopravnénou

obchodni vyhodu.

Institution will not, and will

take measures to ensure that

individuals associated with

Institution will not, accept in

the future any payment

intended to improperly obtain

or retain business for P zer or

to gain an improper business

advantage for P zer.

Zdravotnické za 'zeni neprijme (a

zajisti, aby nepf‘ij aly ani zadné

osoby, které jsou s nim

propojeny) v budoucnu zadnou

castku za uéelem neopravnéného

ziskani nebo udrzeni zakazky pro

spolecnost P zer nebo ziskani

neopravnéné obchodni vyhody

pro tuto spolecnost.

10.3. Non-Compliance. Failure to

comply with, or a demonstrated

intent to fail to comply with, any

of the warranties in Section 11.2,

10.3 PM
Nedodrzeni zaruk nebo projev

umyslu nedodrzet nékterou ze zaruk

uvedenych v clanku 11.2 pfedstavuj e

zavaZné poruseni smlouvy, na

18



above, will constitute adequate

cause for P zer to immediately

terminate the Agreement under

Section 9.1 .d, Termination for

Cause. In such a circumstance,

P zer is under no obligation to

provide Institution an opportunity

to cure before termination or to
provide any further payment upon

termination, including any

payment for non-cancelable

commitments by Institution

relating to the Study.

zakladé néhoz m ze spolecnost

P zer odstoupit od smlouvy
s okamiitou platnosti podle

clanku 9.1.d. V takovém pfi’padé

neni spolecnost P zer povinna

umozmt zdravotnickému za 'zeni

napravu pochybeni pred

odstoupenim od smlouvy, ani mu po

odstoupeni nemusi uhradit zadné

dalsi platby véetné plateb za

nezrusitelné zavazky ze strany

zdravotnického za zeni v souvislosti

se studii.

10.4. This Agreement is drawn up in

two copies of the original, each of

which receives one at a time. This

Agreement may be supplemented

or amended only on the basis of

written amendments accepted by

both parties. This Agreement

shall enter into force on the date

of its signature by both parties
and effective as of the date of its

publication in the register of

contracts pursuant to Act No.

340/2015 Coll. The parties

declare that this agreement

expresses their true, serious, free

and complete will, simple

mistakes. In witness whereof the

authorized representatives of the

parties attach their signatures.

10.4 Tato smlouva je vyhotovena

ve 2 stejnopisech s platnosti

originalu, z nichz kaZda strana

obdrzi po jednom. Tato smlouva

m Ze byt doplnovana éi ménéna

pouze na zakladé pisemnych

dodatk , akceptovanych obéma

stranami. Tato smlouva nabyva

platnosti dnemjej iho podpisu obéma

stranami a ucinnosti dnem jejiho

uvefejnéni v registru smluv dle

zakona c. 340/2015 Sb. Strany
prohlasuj i, 26 tato smlouva vyjadruje

jejich pravou, Vaznou, svobodnou a

uplnou v li, prostou omyl . Na
d kaz shora uvedeného pripojuji

opravnéni zastupci stran své podpisy.

Accepted and Agreed to by:/ Smlouvu potvrdil a schvalil:

P zer, spol. S no

29. 11. 2017

—Managing Director/Jednatel DATE/DATUM

Fakultni Nemocnice Hradec Kralové:

19



29.11. 2017

prof. MUDr. Vladimir Paliéka, CSc., dr. h. c., Director DATE/DATUM

Read and Acknowledged by/ Smlouvu pfeéetl a souhlasi:

29. 1 1. 2017

—,hlavni zkou§ejici DATE/DATUM

Priloha A

ROZVRH PLATEB

Platby Castka EUR

Prvni platba (pozn. Viz nize) EUR 17 096,21

Druha platba (pozn. Viz nize) EUR 14,596.21 (31 brezna 2018)

Zévéreéna platba (pozn. Viz nize) EUR 2,500

Celkem EUR 34 192, 42

Prvni platba. P zer neprovede prvni platbu drive, nez obdrzi podepsanou kopii smlouvy.

Druhé platba. P zer provede druhou platbu do 31 brezna 2018.

Zévéreéna platba. P zer provede zévéreénou platbu po obdrzeni zavéreéné zprévy

o vysledcich studie a splneni V§ech povinnosti vyplyvajicich ze smlouvy.

Attachment A

PAYMENT SCHEDULE

Milestone Payment amount EUR

Initial payment (see note below) EUR 17 096,21

Second payment (see note below) EUR 14,596.21 (31St March 2018)

20



Final payment (see note below) EUR 2,500

Total EUR 34 192, 42

Initial Payment. P zer will make no initial payment until P zer has received an executed

copy of the Agreement

Second payment. P zer will make the second payment in 3 lst March 2018.

Final Payment. P zer will make the nal payment only after receipt of the Study Report and

completion of any applicable remaining obligations under the Agreement.

21