Textová podoba smlouvy Smlouva č. 4380944: Klinické hodnocení - GE Healthcare

                        Untitled


Assignment

of

Clinical Site Agreement

dated 26‘“April 2016

Study Protocol: GE-122-020

Study Title: “AdreView Myocardial

Imaging for Risk Evaluation - A
multicenter trial to guide ICD

implantation in NYHA class II & III heart
failure with 300/0 < LVEF< 35%.

ADMIRE-ICD”

This Agreement (the “Assignment
Agreement”) is entered into

by and between:

- GE Healthcare Limited with its seat at

Amersham Place, Little Chalfont,

Buckinghamshire, HP7 9NA, Great Britain,

Company No.: 01002610, hereinafter
referred to as the “Sponsor”

and

- TFS Trial Form Support, s.r.o. with its

registered office in Prague 1216/46
Klimentské Str., 11002 Prague 1, Czech

Republic, ID: 27876756, VAT:

C227876756, entered in the commercial
register kept by the District Court in

Prague (Section C, number 123492),

represented by

Proxy, hereinafter referred to as “TFS”

and

- Fakultni nemocnice Hradec

Kralové, Sokolska’ 581, 500 05
Hradec Kra’lové Novy Hradec, Czech
Republic, represented by prof. MUDr.

Vladimir Paliéka, CSc., dr. h. c.,

7VAT: CZ00179906,

Postoupeni

smlouvy

pro klinické pracovisté

ze dne 26. dubna 2016

Protokol klinického hodnoceni: GE-122-020

Na’zev klinického hodnoceni: "Zobrazovani
myokardu s pouiitim pFipravku
AdreViewTM k vyhodnoceni rizika —

multicentrické klinické hodnoceni
k Fizenl’ rozhodovani o implantaci ICD u
pacientfi se srdeEnim selhanim ti‘l’dy
NYHA II a III a s 30 “Va < LVEF < 35 °/o.
ADMIRE-ICD“

Tato smlouva (,,sm|ouva o postoupeni“) se
uzavira

mezi spoleénostmi:

- GE Healthcare Limited se sidlem na
adrese Amersham Place, Little Chalfont,

Buckinghamshire, HP7 9NA, Velka’
Britanie, (":islo spoleénosti: 01002610,
dale jen ,,zadavate|“

- TFS Trial Form Support, 5. r. 0. se

sidlem v Praze na adrese Klimeptské
ulice 1216/46,V 110 02 Praha 1, Ceslga

republika, ICO: 27876756, DIC:

C227876756, vedenou v obchodnim

rejstriku u okresniho soudu v
Praze (vloika C, Eislo 123492),
zastoupenou panem

zastupce, dale oznaéovanou

jako,,TFS“

nemocnici Hradec
Sokolské 581, 500 05

Hradec Krélové - Novy Hradec
Kra’lové, Ceska’ republika,
zastoupenou prof. MUDr. Vladimirem

Palickou, CSc., dr. h. c., Feditelfiemh

- Fakultni

Kralové,

GE-122-020_Czech Republic_Tripartite INS - Fakultni nemocnice Hradec Krélové_site number 854_Pl:_
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hereinafter referred to as the

“Provider”

and

-—1-
Interni kardioangiologicka’ klinika,

Fakultni nemocnice Hradec Kralové,
Sokolska 581, 500 05 Hradec Krélové—

Novy Hradec Kralové, Czech Republic,
hereinafter referred to as the

“Investigator”,

and hereinafter jointly referred to as “the

Parties”.

THE PARTIES AGREED AS FOLLOWS:

1. GE Healthcare Limited with its seat at

Amersham Place, Little Chalfont,

Buckinghamshire, HP7 9NA, Great Britain

is sponsoring the clinical study entitled

“AdreView Myocardial Imaging for
Risk Evaluation — A multicenter trial

to guide ICD implantation in NYHA

class II & III heart failure with 30%
< LVEF< 35%. ADMIRE-ICD"

(hereinafter the "Study"), according to
the protocol with number GE-122-020

(hereinafter the "Protocol").

2. The Investigator, the Provider and TFS

entered into a Clinical Site Agreement on

26th April 2016 (the "Agreement”),
related to Study conduct.

3. As of 7*“ August 2017 (the “Assignment
Date”), all rights and responsibilities of

TFS under the Agreement will now be

borne by the Sponsor of the Study — GE

Healthcare Limited and its Affiliates.

As of the Assignment Date, TFS hereby
assigns to the Sponsor, all its rights and

obligations arising out of the Agreement.

DIc: CZOOl79906, dale jen
,,poskytovatel“

Ph.D., 1. Interni kardioangiologicka
klinika, Fakultni nemocnice Hradec

Kralové, Sokolska 581, 500 05

Hradec lgralové — Novy Hradec
Kralové, Ceska republika, dale jen

,,zkousejici“,

které se dale souhrnné budou oznaéovat jako

,,strany“.

SllflLUVNI VSTRANY SE DOHODLY
W:

1. Spolecnost GE Healthcare Limited se

sidlem na adrese Amersham Place, Little

Chalfont, Buckinghamshire, HP7 9NA,

Velké Britanie, je zadavatelem klinické

studie s nézvem ,,Zobrazovéni

myokardu spouiitim pi‘ipravku
AdreViewTM kvyhodnoceni rizika —

multicentrické klinické hodnoceni

kFizenI’ rozhodovéni o implantaci
ICD u pacientfi se srdeénl’m
selhénim tFidy NYHA II aIII as

30 °/o < LVEF < 35 0/0. ADMIRE-ICD“

(da’le jen ,,studie“), v souladu s
protokolem Eislo GE-122-020 (dale jen

,,protokol“).

Zkous’ejl'ci, poskytovate/ a spolecnost
TFS uzavFeli smlouvu pro klinické

pracovisté dne 26. dubna 2016 (dale

jen ,,smlouva“). Tato smlouva se tyka

provadéni studie.

Ke dni 7. srpna 2017 (,,datum

postoupem“) se prevédéjl' veékera prava
a povinnosti spoleEnosti TFS podle

smlouvy na zadavatele studie —

spolecnost GE Healthcare Limited a

jeji pFidruiené spoleénosti.

K datu postoupeni tI'mto spolecnost TFS
predévé zadavateli veékera’ sva préva a
zavazky vyplyvajici ze smlouvy.

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As of the Assignment Date, the Sponsor

hereby accepts all rights and obligations

of TFS arising out of the Agreement.

The Provider and the Investigator hereby

consent to such assignment as of the

Effective Date (as defined below in point
11).

A person designated by the Sponsor will

contact the Provider and the Investigator

to ensure a smooth transition, while TFS

and the Sponsor complete transition of

the Study responsibilities.

All the invoices as of the 7th August 2017
— Assignment Date, will be handled by

GE Healthcare and should be issued and
sent to:

GE Healthcare Limited

Attn

The Grove Centre

White Lion Road

Amersham

HP7 9LL, UK

Email:

VAT No.: GB669318888

All the notices from the Investigator and
the Provider as of the Assignment Date,

should be issued and sent to:

GE Healthcare Limited

Attn:

The Grove Centre

White Lion Road

Amersham

HP7 9LL, UK

Phon

Mobil

Email—

If required by Applicable Laws, the

Sponsor will notify the competent
authorities in Czech Republic about the

assignment of the Agreement. The

_Investigator and the Provider undertake,

H30-Nov—2017_Fina|

K datu postoupeni timto zadavatel,

prijima veskera prava a zavazky
spolecnosti TFS vyplyvajici ze smlouvy.

Poskytovate/ a zkousejl'ci tlmto souhlasi
s tlmto postoupenim k datu ucinnosti
(jakje definovano nlie v bodé 11).

Osoba, kterou povéFI’ zadavatel, bude
kontaktovat poskytovate/e a

zkousvejiciho s cilem zajistit hladky
pFevod. Mezitim spolecnost TFS a

zadavatel dokonci pFevod povinnosti
souvisejicich se studii.

vsechny faktury od data postoupeni, tj.
7. srpna 2017, bude zpracovévat
spolecnost GE Healthcare. Na fakturach

uva'déjte nasledujici Udaje a zasilejte je
na adresu:

GE Healthcare Limited

K ruka’m

The Grove Centre

White Lion Road

Amersham

HP7 9LL, Velké Britanie

Email—
DIC: 63669318888

Veskeré oznameni od zkousvejl’cihO a
poskytovate/e od data postoupeni
adresujte a zasllejte na adresu:

GE Healthcare Limited

K rukém_
The Grove Centre

White Lion Road

Amersham

HP7 9LL, Velka Britanie

Telefon:

Mobilni telefon:

E-mail

Pokud to vyiaduji platné zakony,
zadavatel o postoupeni smlouvy

uvédoml' pFislusné organy v Ceské
republice. Zkous"ej/'ci a poskytovate/ se

,zava,zuji_nap0méhat zadavatel] pti

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to assist the Sponsor in such procedure, tomto kroku, bude—li to tFeba.

if needed.

8. Notwithstanding any provisions of the 8. Bez ohledu na jaka’koli ustanovem’ ve
Agreement, the Parties hereby agree and smlouvé se smluvm’ strany ti’mto
confirm that both the Agreement dohodly a potvrzuji, ze smlouva (véetné
(including previous or future pFedchozich (”2i budoucich dodatkfi,
amendments, if any) and this vzniknou-li) a tato smlouva 0
Assignment Agreement constitute an i postoupeni' predstavuji nedilnou souéa’st

integral part of the arrangements ujednani' mezi stranami v ra’mci

between the Parties in scope of the terms podminek pro prova’déni studie.
of Study conduct.

9. This Assignment Agreement shall be 9. Tato smlouva o postoupem’ se bude Fidit
governed by the Laws of Czech Republic. zakony Ceské republiky. Veskeré

Any issues not regulated under the zalezitosti, které nejsou upraveny
Assignment Agreement shall be governed smlouvou o postoupem’, se budouv Fidit
by the appropriate regulations of Czech prislusnymi zakonnymi pFedpisy Ceské
law. republiky.

10. This Assignment Agreement may be 10. Tato smlouva o postoupeni' mfize byt
executed in counterparts, in Czech and vyhotovena ve stejnopisech, v Eeské a
English language version. In case of anglické jazykové verzi. V pFi’padé

discrepancies, the Czech version shall be nesrovnalosti' bude zavazujl'ci ceské

the binding one. Each counterpart, taken verze. Kazdy stejnopis (spolecné)
together, shall constitute a fully executed predstavuje Fédné uzavFenou smlouvu 0

Assignment Agreement. postoupeni'.

11. This Assignment Agreement enters into 11.Tato smlouva o postoupem’ vstupuje v

force as of the last signature date (the ucinnost k datu posledniho podpisu
“Effective Date”), and may be amended (,,datum ucinnosti“) a Ize ji upravovat

only by a written amendment signed by pouze na za'kladé pi'semného dodatku
the Parties. podepsaného smluvni'mi stranami.

12. The Contractual Parties undertake to 12.Strany se zavazuji Fesit vsechny

settle any possible differences or pFI’padné rozpory nebo spory vyplyvajici
disputes resulting from this Agreement ztéto Smlouvy prednostné smirnym
preferably in an amicable manner. zpfisobem. Pokud by nebylo mozné
Should an amicable solution not be dosahnout smi'rného reseni’, budou
attainable, any conceivable disputes vsechny pripadné spory vyplyvaji'ci
resulting from this Agreement shall be ztéto “Smlouvy reseny pFislusnymi
resolved by ordinary courts of the Czech soudy Ceské republiky.
Republic.

13. The Parties agree that this Agreement 13.Smluvni strany se dohodly, ze tato
shall be published in the Register of smlouva bude uverejnéna vregistru
Contracts with originl contract smluv s pfivodni' smlouvou (dale jen ,,
(hereinafter only “contract”), and the smlouva“) a uveFejnéni’ smlouvy
Provider shall publish the Agreement. provede Poskytovatel.

14. The Parties agree that Sponsor specified

business secret shall be removed before 14.Sm|uvni' strany se dohodly, ze oznacené

submission of the Agreement to the obchodni' tajemstvi zadavatelem, bude

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Register of Contracts and Agreement

Annexes shall not be published in the

Register of Contracts. Prior to signing of

the Agreement, the Sponsor shall send to

the Provider a final version of the
Agreement in a machine—readable format

with highlighted text that the Sponsor

considers a business secret.

The anticipated maximum value of

performance i

15. All other terms and conditions of the

Agreement shall remain the same and in

full force and effect.

pFed zada’nl'm smlouvy do registru
smluv odstranéno a pIV'I'lohy smluv
nebudou v registru smluv uveFejnovany.
PFed podpisem smlouvy Zadavatel zasle

Poskytovateli finalnl' verzi smlouvy ve
strojové citelném formatu s
podbarveny'Im textem smlouvy, které

povaiuje Zadavatel za obchodm’
tajemstvl.

Predpoklédané maximalnl' hodnota plnénl'

15.V§echny smluvni podmlnky smlouvy

zfista’vaji beze zmény a v plné platnosti
a ucinnosti.

The Sponsor: IGE HEALTHCARE: I
Zadavatel: l GE HEALTHCARE:

Date/Datum:
2

_ a , .7

Signature / Podpis

Printed Name / Jméno hulkovvm plsmem:

—
Head of Global Operations

Core Imaging R&D

Investigator / Zkousejici:

Date / Datum:

Signature / Podpis:

Printed Name/Jméno hulkovym plsmem:

TFS ITFS:

120Date / Datum:

Signature / Podpis:

Printed Name / Jméno hfilkovy pis‘

Director Finance, TFS West & East Europe /
Finanéni feditel. TFS West & East Europe

Person authorised to sign agreements for the
Provider I Osoba oprévnéné podepisovat
smlouvy pro poskytovatele:

Date / Datum:

Signature / Podpis:

Printed Name / Jméno hulkovym pismem:

prof. MUDr. Vladimir Paliéka, CSc.. dr. h. c.

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n “it Iv,“