ContractClinical Study Agreement • August 3rd, 2023
CLINICAL STUDY AGREEMENT ZMLUVA O KLINICKOM SKÚŠANÍ between medzi PAREXEL International (IRL) Limited PAREXEL International (IRL) Limited and a Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica Pfizer Protocol # C4221023 Protokol spoločnosti Pfizer č. C4221023 This Clinical Study Agreement (“Agreement”)between Táto zmluva o klinickej skúšaní (ďalej„zmluva”) medzi PAREXEL International (IRL) Limited, with a place of business at 70 Sir John Rogerson's Quay Dublin 2, Ireland (“CRO”) PAREXEL International (IRL) Limitedsídlom na adrese 70 Sir John Rogerson's Quay,Dublin 2, Ireland (ďalej „CRO”) and a Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica,with a place of business at Námestie L. Svobodu 1, 975 17 Banská Bystrica, Slovak RepublicID Number: 00 165 549Represented by: Ing. Miriam Lapuníková, MBA- directorEstablished by the Charter of the Ministry of Health of t
ContractClinical Study Agreement • June 12th, 2019
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉM HODNOCENÍ This Clinical Study Agreement (this “Agreement”) when signed by all parties, will set forth certain agreements by and between IQVIA RDS Czech Republic s.r.o., having a place of business at Pernerova 691/42, 186 00 Praha 8 – Karlín, Czech Republic, Identification number: 247 68 651, Tax identification number: CZ24768651, represented by(“IQVIA” or “CRO”) and Fakultní nemocnice Brno, having a place of business at Jihlavská 20, 625 00 Brno, Czech Republic,Identification number: 652 69 705, Tax identification number: CZ65269705, represented by(the “Institution”) and, born ,located at(the “Investigator”) to conduct the Study (as defined below) in relation to the Investigational Product(s) (as defined below)) effective as of the date of publication of this Agreement in the Register of Agreements (the “Effective Date”). Tato smlouva o klinickém hodnocení (dále jen„Smlouva“) bude po podpisu všech smluvních stran tvořit ujednání me
CLINICAL STUDY AGREEMENTClinical Study Agreement • September 26th, 2020
WHEREAS, Institution has appropriate facilities and personnel necessary to conduct the Study and will provide the services of principal investigator.
ContractClinical Study Agreement • May 18th, 2017
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of its publication in the Agreements Register in accordance with Act no. 340/2015 Coll., on Agreements Register. The parties hereby agree that their rights and duties shall be governed by this Agreement from the date of the last signature (“Effective Date”) by and between, Oblastní nemocnice Příbram, a.s. located at Gen. R. Tesaříka 80, Příbram, ZIP 26101, Czech Republic, Identification Number 27085031, Tax Identification Number CZ27085031 (“Study Site”), havinghis work address at: Gen. R. Tesaříka 80, Příbram, ZIP 26101, Czech Republic (“Principal Investigator”), and Daiichi Sankyo, Inc., located at 399 Thornall Street, Edison, New Jersey 08837 (“DSI”). Study Site and DSI are each referred to as a “Party” and collectively as the “Parties.” Tato smlouva o klinické studii (dále jen„smlouva“) se uzavírá v okamžiku svého zveřejnění v registru smluv v souladu se zá
CLINICAL STUDY AGREEMENTClinical Study Agreement • July 17th, 2018
Fakultní nemocnice Hradec Králové (University Hospital Hradec Králové) - IV. Interní Hematologická klinika (4th Internal Clinic of Hematology)
HODNOCENÍClinical Study Agreement • March 1st, 2021
společností ICON Clinical Research Limited, DIČ: IE 8201978R se sídlem South County Business Park, Leopardstown, Dublin 18, Irsko zastoupenou panem (dále jen
CLINICAL STUDY AGREEMENT PROTOCOL: DAL-301 SITE: 18-106 DALCOR PHARMA UK LTD 07 - OCT- 2016 VERSION: 1 . 0 COUNTRY : CZECH REPUBLIC SMLOUVA O KLINICKÉ STUDII PROTOKOL: DAL-301 CENTRUM: 18-106 DALCOR PHARMA UK LTD 07 - ŘÍJEN- 2016 VERZE: 1 . 0 ZEMĚ:...Clinical Study Agreement • October 11th, 2016
CLINICAL STUDY AGREEMENTThis clinical study agreement (“Agreement”), dated 07-OCT-2016 (the “Effective Date”), is entered into by and between the partiesMedpace, Inc., with its principal office and place of business at 5375 Medpace Way, Cincinnati, Ohio 45227, USA (“Medpace”),andFakultni nemocnice Brno, a clinical research site with its principal office and place of business at Jihlavska 20, 625 00 Brno, Czech Republic, company registration number: 65269705, tax identification number: CZ65269705 (“Institution”),and .Medpace, Institution, and Principal Investigator are sometimes collectively referred to herein as parties (the “Parties”). DalCor Pharma UK Ltd (“Sponsor”) is sponsoring a clinical study on the compound Dalcetrapib (the “Study Drug”), in accordance with Protocol No. DAL-301, titled “A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary
CLINICAL STUDY AGREEMENT SMLOUVA O PROVEDENÍ KLINICKÉHO HODNOCENÍClinical Study Agreement • December 19th, 2016
CLINICAL STUDY AGREEMENT PROTOCOL: NEF-301 OLE SITE: CZ05PROF. IVAN RYCHLIK ,MD, PHD, FASN, FERA INSTITUTION: FAKULTNI NEMOCNICE KRALOVSKE VINOHRADY CALLIDITAS THERAPEUTICS AB. VERSION:#1COUNTRY: CZECH REPUBLIC SMLOUVA O KLINICKÉ STUDII PROTOKOL:...Clinical Study Agreement • April 20th, 2021
CLINICAL STUDY AGREEMENTThis clinical study agreement (“Agreement”), dated 20th April 2021 and effective as of the day of publication in the Contracts Registry (the “Effective Date”), is entered into by and amongMedpace Clinical Research, LLC, with its principal office and place of business at 5375 Medpace Way, Cincinnati, Ohio 45227, USA ("Medpace”), represented by ; Fakultni Nemocnice Kralovske Vinohrady , with its principal office at Srobarova 1150/50, 100 34 Praha 10, Czech Republic ("Institution”), represented by MUDr. Jan Votava, MBA, deputy for Medical and Preventive Care, representative of statutory body of FNKV, reference number KH 37/2020, cost center: 21015AndProf. Ivan Rychlik, M.D.,PhD, FASN, FERA, chief of Internal Clinic, Srobarova 1150/50, 100 34 Praha 10,Czech Republic, Date of Birth (“Investigator”).Medpace, Institution, and Investigator are sometimes collectively referred to herein each as a “Party” or collectively as the “Parties”.WHEREAS, Calliditas Therapeutics AB
ContractClinical Study Agreement • July 10th, 2012
No. Date Č.Dátum CLINICAL STUDY AGREEMENT ZMLUVA O KLINICKOM SKÚŠANÍ This Agreement is entered into in accordance with section 269, subsection 2 of the Commercial Code by and between: Uzatvorená podľa ust. § 269 ods. 2 Obchodného zákonníka medzi zmluvnými stranami: (1) Order Party (1) Zadávateľ Accelsiors CRO and Consultancy Services (hereinafter referred to as “Accelsiors”), a company registered in the Hungarian Companies Register, having its registered office at Miskolci Street 50, 1147 Budapest, Hungary Represented by:Dr. Mihaly Juhasz – Managing Director Tel: +36 1 2990091Fax: +36 1 2990096E-mail: M.Juhasz@accelsiors.com Seated: Miskolci Street 50 1147 Budapest HUNGARY Company registration No.: Cg.01-09-737576 Accelsiors CRO and Consultancy Services (Accelsiors CRO a poradenské služby), (nižšie v dokumente označované ako “Accelsiors”), spoločnosti, ktorej sídlo je registrované v obchodnom registri Maďarska na adrese Miskolci 50, 1147 Budapest, Hungary Zastúpená:Dr. Mihaly Juhasz
ContractClinical Study Agreement • December 17th, 2018
CLINICAL STUDY AGREEMENT Drug Substance Roxadustat Study Code D5740C00002 SMLOUVA O ZAJIŠTĚNÍ KLINICKÉHO HODNOCENÍ HUMÁNNÍHO LÉČIVÉHO PŘÍPRAVKUuzavřená mezi ASTRAZENECA CZECH REPUBLIC s.r.o.aKrajská zdravotní, a.s. Zkoumaný léčivý přípravek AstraZeneca Roxadustat Název Klinického hodnocení A Phase 3, Multicenter, Randomized, Open-Label, Active- Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients Číslo Místa Klinického hodnocení 1906 Hlavní zkoušející Datum uzavření Smlouvy o mlčenlivosti NA
CLINICAL STUDY AGREEMENTClinical Study Agreement • August 22nd, 2016 • Massachusetts
This CLINICAL STUDY AGREEMENT (“Agreement”) is made effective as of the [NUMBER] day of [MONTH], [YEAR] (the “Effective Date”), and is by and among SPONSOR_________________________________, a ___________ corporation, with offices at _____________________________________________ (“SPONSOR”) and [INSTITUTION NAME], a [ ] corporation with offices at [ADDRESS] (“Institution”).
ContractClinical Study Agreement • July 19th, 2017
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This clinical study agreement (“Agreement”), effective as of 18 July 2017 (the “Effective Date”), is entered into by and between(1) Cortendo AB with its registered office at Kullegarde 38, 433 68, Sweden (“Sponsor”); (2) Cmed Clinical Services ,Holmwood, Broadlands Business Campus, Langhurstwood Road, Horsham, West Sussex, RH12 4QP, United Kingdom (“Cmed”); (3) Hradec Králové University Hospital, address: Sokolská 581, 500 05 Hradec Králové – Nový Hradec Králové, Czech Republic, Tax Registration No: CZ00179906,represented by: Prof. MUDr. Roman Prymula, CSc., Ph.D., Director-General (“Healthcare Tato smlouva o klinické studii („smlouva“) účinná k datu 18. července 2017 („datum účinnosti“) se uzavírá mezi (1) společností Cortendo AB se sídlem na adrese Kullegarde 38, 433 68, Švédsko („zadavatel“), (2) společností Cmed Clinical Services, Holmwood, Broadlands Business Campus, Langhurstwood Road, Horsham, West Sussex, RH12 4QP, United Kingd
ContractClinical Study Agreement • February 4th, 2020
CLINICAL STUDY AGREEMENT by and among Worldwide Clinical Trials Limited, incorporating its Affiliates, with a principal place of business located at Waterfront House, Beeston Business Park, Beeston, Nottingham, NG9 1LA, United Kingdom on behalf of and as an authorized agent of Merz Pharmaceuticals GmbH (as defined below) (Hereinafter known as “WCT”) on the first part, and Fakultní nemocnice Olomouc with a principal place of business at I. P. Pavlova185/ 6, Olomouc 77900, Czech Republic, Identification Number: 00098892, VAT ID CZ00098892 , represented by: prof. MUDr. Roman Havlík, Ph.D., Director (Hereinafter known as the “Institution”) on the second part and XXX with its principal place of business at Fakultní nemocnice Olomouc, I. P. Pavlova 185/6, Olomouc 77900, Czech Republic (Hereinafter known as the “Investigator”) on the third part, (each a “Party” and collectively the “Parties”) Insert STUDY: A clinical research study entitled XXX” (Hereinafter known as the “Study”) Intr
CLINICAL STUDY AGREEMENTClinical Study Agreement • January 13th, 2006 • Protalex Inc • Services-commercial physical & biological research • Pennsylvania
THIS Clinical Study Agreement (this “Agreement”) is entered into as of the execution date of the last party to sign below (the “Effective Date”), by and between Protalex, Inc., a corporation organized and existing under the laws of the State of Delaware, with an address at 145 Union Square Drive, New Hope, PA 18938 (“SPONSOR”) and PAREXEL International LLC, a limited liability company organized and existing under the laws of the State of Massachusetts, with an address at 200 West Street, Waltham, MA 02451 (“PAREXEL”).
CLINICAL STUDY AGREEMENT – COMPASSClinical Study Agreement • January 15th, 2019
This Site Agreement for the performance of a clinical trial (hereinafter the “Agreement”) is entered into and effective this 4th day of July 2014 (“Effective Date”) between Nemocnice České Budějovice, a.s. with its principal place of business at B. Němcové 585/54, České Budějovice, 37001, Czech Republic (hereinafter the “Institution”) represented by
ContractClinical Study Agreement • January 9th, 2017
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of signature of the last Party (“Effective Date”) by and between, Fakultní nemocnice Hradec Králové located at Sokolská 581, 500 05 Hradec Králové – Nový Hradec Králové, Czech Republic (“Provider”),located at Sokolská 581, 500 05 Hradec Králové – Nový Hradec Králové, Czech Republic (“Principal Investigator”), and Daiichi Sankyo, Inc., located at 399 Thornall Street, Edison, New Jersey 08837, USA (“Sponsor”). Provider, Principal Investigator and Sponsor are each referred to as a “Party” and collectively as the “Parties.” The authorised representative of Sponsor for the EU is Covance CAPS Ltd. , having a principal place of business at Osprey House, Maidenhead Office Park, Westacott Way, Maidenhead SL6 3QH, United Kingdom (“CRO”) which meets conditions of §51 par 2 letter d) of Act 378/2007 Coll. Tato smlouva o klinické studii (dále jen„smlouva”) se uzavírá ke dni
ContractClinical Study Agreement • May 27th, 2019
administer payments from an IQVIA RDS Inc.bank account to the Payee (as defined below) on this Study; IQVIA RDS Inc. na účet příjemce plateb(definice viz níže) za tuto studii bude spravovat společnost DrugDev, dceřiná společnost CRO; WHEREAS, DSI desires that Study Site and Principal Investigator participate in the conduct of a multi-center clinical study (the “Study”), based on Protocol No. DS8201-A-U301 entitled “A Phase 3, Multicenter, Randomized, Open-Label, Active- Controlled Study of DS-8201a, An Anti- Her2-Antibody Drug Conjugate, Versus Treatment of Investigator’s Choice for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated with Prior Standard of Care HER2 Therapies, Including T-DM1” (the“Protocol”); JELIKOŽ si DSI přeje, aby se studijní pracoviště a hlavní zkoušející podíleli na provádění multicentrické klinické studie (dále jen „studie“) prováděné dle protokolu č. DS8201-A-U301 nazvané „Multicentrické, randomizované, otevřené, aktivně kontrol
Cornell University for its Medical College Research and Sponsored Programs New York, N.Y. 10021 Clinical Study AgreementClinical Study Agreement • April 9th, 2004 • Neurologix Inc/De • Pharmaceutical preparations • New York
This CLINICAL STUDY AGREEMENT (the “Agreement”) between Cornell University for its Medical College, hereinafter referred to as “the Medical College,” and Neurologix, Inc., hereinafter referred to as the “Sponsor,” is entered into as of July 2, 2003 (“Effective Date”).
CLINICAL STUDY AGREEMENTClinical Study Agreement • April 9th, 2004 • Neurologix Inc/De • Pharmaceutical preparations • New York
This Agreement, is made by and between NEUROLOGIX, INC., hereinafter referred to as “SPONSOR,” with its principal office located at 271-32 E. Grand Central Parkway, Floral Park, NY 11005, and NORTH SHORE UNIVERSITY HOSPITAL a not-for-profit corporation organized and existing under the laws of the State of New York, with its principal office located at 300 Community Drive, Manhasset, NY 11030, hereinafter referred to as “INSTITUTION,” as of this day of July, 2003 (“Effective Date”).
ContractClinical Study Agreement • January 31st, 2019
CLINICAL STUDY AGREEMENT With an Effective Date of date of Agreement publication in the Register of Contracts (Hereinafter known as the “Effective Date”) SMLOUVA O PROVEDENÍ KLINICKÉ STUDIE s datem účinnosti ke dni uveřejnění smlouvy v registru smluv (dále jako „datum účinnosti“)
ContractClinical Study Agreement • November 3rd, 2016
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of its publication in the Agreements Register in accordance with Act no. 340/2015 Sb., on Agreements Register. The parties hereby agree that their rights and duties shall be governed by this Agreement from the date of execution hereof (“Effective Date”) by and between, Nemocnice Halvíčkův Brod, příspěvková organizace located at Husova 2624, Havlíčkův Brod, ZIP 58001, Czech Republic, Identification Number: 00179540, Tax Identification Number: CZ00179540 (“Study Site”), and Daiichi Sankyo, Inc., located at 399 Thornall Street, Edison, New Jersey 08837 (“DSI”). Study Site and DSI are each referred to as a “Party” and collectively as the “Parties.” Tato smlouva o klinické studii (dále jen„smlouva“) se uzavírá v okamžiku svého zveřejnění v registru smluv v souladu se zákonem č. 340/2015 Sb., o registru smluv. Strany se tímto dohodly, že jejich práva a povinnosti se
CLINICAL STUDY AGREEMENTClinical Study Agreement • July 15th, 2009
This Agreement is entered into as of this _____ day of _______, 20__ between The University of Texas System, [Branch] with its principal location in _________ (hereinafter referred to as "INSTITUTION") and Merck & Co., Inc., a New Jersey corporation with its principal place of business in Rahway, New Jersey (hereinafter referred to as "MERCK") upon the following terms and conditions:
ContractClinical Study Agreement • September 14th, 2020
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of 20-Dec-2016 (“Effective Date”) by and between, Ústav Hematologie a krevní transfuze located at U Nemocnice 2094/1, 128 20 Praha 2, Czech Republic (“Study Site”), located at U Nemocnice 2094/1, 128 20 Praha 2, Czech Republic (“Principal Investigator”), and Daiichi Sankyo, Inc., located at 399 Thornall Street, Edison, New Jersey 08837, USA (“DSI”). Study Site, Principal Investigator and DSI are each referred to as a “Party” and collectively as the “Parties.” Tato smlouva o klinické studii (dále jen„smlouva”) se uzavírá ke dni 20.12.2016 (dále jen „datum účinnosti”) mezi Ústav Hematologie a krevní transfuze na adrese U Nemocnice 2094/1, 128 20 Praha 2, Česká republika (dále jen „studijní pracoviště”), na adrese U Nemocnice 2094/1, 128 20 Praha 2, Czech Republic (dále jen „hlavní zkoušející”), a společností Daiichi Sankyo, Inc., se sídlem na adrese 399 Thornall
ContractClinical Study Agreement • January 23rd, 2019
DODATOK č. 1 K ZMLUVE O KLINICKOMSKÚŠANÍ (ďalej len „Zmluva“) uzatvorenej podľa § 269 ods. 2 zák. č. 513/1991 Zb. Obchodný zákonník, v znení neskorších predpisov, dňa 5. februára 2018 (ďalej len„Dodatok“) AMENDMENT no. 1 TO THE CLINICALSTUDY AGREEMENT (the „Agreement“) concluded under Section 269 par. 2 of Act no. 513/1991 Coll., Commercial Code, as amended, as of 5 February 2018 (the„Amendment“) Čl. I. Zmluvné strany 1. AbbVie s.r.o.So sídlom : Karadžičova 10,821 08 Bratislava, Slovenská republika,IČO: 46640231,DIČ: 2023529057,IČ DPH: SK2023529057,Štatutárny orgán: Branislav Trutz, M.D.,konateľ zapísanou v obchodnom registri Okresného súdu Bratislava I, oddiel:, vložka č. 81375/B, deň zápisu: 11.05.2012,ako splnomocnený zástupca zadávateľa na základe plnej moci zo dňa 24.januára.2018(ďalej len spoločnosť “AbbVie”) 2. Univerzitná nemocnica L. Pasteura KošiceSo sídlom: Rastislavova 43,041 90 Košice, Slovenská republika,v zastúpení: MUDr. Milan Maďar, MPH, generálny riaditeľ,Ing. Roman Š
ContractClinical Study Agreement • December 6th, 2019
CLINICAL STUDY AGREEMENT ZMLUVA O KLINICKOM SKÚŠANÍ Protocol # HTL0018318-S01 Protokol č. HTL0018318-S01 This Clinical Study Agreement (“Agreement”) concluded pursuant to Section 269 (2) of Act no. 513/1991 of Coll., the Commercial Code, as amended, dated as of the date of last signature and effective on the following day after the day of publication pursuant to section 47a par.1 of the Act no. 40/1964 Coll., Civil Code as amended, in the central register of agreements on www.crz.gov.sk, as this is considered as mandatory publication of agreement pursuant to section 5a, par.1 of the Act no. 211/2000 Coll., on freedom access to information, as amended. The Sponsor (as defined below) agrees to disclose the Agreement according to the previous sentence concluded among Táto zmluva o klinickom skúšaní (ďalej len „zmluva“) uzatvorená podľa § 269 ods. 2 a nasl. zákona č. 513/1991 Zb. Obchodný zákonník v platnom znení nadobúda platnosť k dátumu pripojenia posledného podpisu a účinnosť dňom na
CLINICAL STUDY AGREEMENT – ARTESiAClinical Study Agreement • May 31st, 2018
This Clinical Study Agreement (hereinafter the “Agreement”) is entered into and effective upon the publication hereof in the register of contracts (“Effective Date”) between Fakultní nemocnice Hradec Králové (University Hospital), with its principal place of business at Sokolská 581, 500 05 Hradec Králové, Czech Republic (hereinafter the “Provider”)
CLINICAL STUDY AGREEMENT PROTOCOL: OP0595-5 SITE: ME5-11-03 MEIJISEIKA PHARMA CO., LTD. VERSION: VERSION#1 COUNTRY: SLOVAKIA ZMLUVA O KLINICKOM SKÚŠANÍ PROTOKOL: OP0595-5 PRACOVISKO: ME5-11-03 MEIJISEIKA PHARMA CO., LTD. VERZIA:VERZIAČ. 1 KRAJINA:...Clinical Study Agreement • August 29th, 2023
CLINICAL STUDY AGREEMENTThis clinical study agreement (“Agreement”), effective from the date of publication in the Central Register of Contracts (the “Effective Date”), is entered into by and among Medpace Clinical Research, LLC, with its principal office and place of business at 5375 Medpace Way, Cincinnati, Ohio 45227 ("Medpace”), and Univerzitna nemocnica Martin a clinical research site with its principal office and place of business at Kollarova 2, 036 59 Martin, Slovakia("Institution”) andhaving an addressat ("PrincipalInvestigator”). Medpace, Institution and Principal Investigator are sometimes collectively referred to herein as parties (the “Parties”). WHEREAS, Meiji Seika Pharma Co., Ltd. (“Sponsor”) is sponsoring a clinical study on the compound Nacubactam (the “Study Drug”), in accordance with Protocol No. OP0595-5, titled A Phase 3, Multi-Center, Randomized, Double- Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imi
CLINICAL STUDY AGREEMENTClinical Study Agreement • August 17th, 2018
Registered office: Sokolská 581, 500 05, Hradec Králové – Nový Hradec Králové, Represented by: prof. Vladimir Palicka, MD, CSc, dr. h. c., Managing Director, IN: 00179906, TIN: CZ00179906 (the “Institution”)
and Fakultní nemocnice Hradec KrálovéClinical Study Agreement • September 22nd, 2017
with a place of business at with a place of business at I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové (“Principal Investigator”),
ContractClinical Study Agreement • October 5th, 2017
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of its publication in the Agreements Register in accordance with Act No. 340/2015 Sb., on Agreements Register. The parties hereby agree that their rights and duties shall be governed by this Agreement from the date (“Effective Date”) by and between, Fakultní nemocnice Plzeň, located at Edvarda Beneše 1128/13, Plzeň, zip code 305 99, Czech Republic, Identification number: 00669806, represented by MUDr. Václav Šimánek, Ph.D., Director (“Study Site”), having his work address as: FN Plzeň – Children’s Clinic – Dept. of Hematology and Oncology, Alej Svobody 80, 304 60 Plzeň, Czech Republic (“Principal Investigator”) and Daiichi Sankyo, Inc., located at 399 Thornall Street, Edison, New Jersey 08837 (“DSI”) represented based on a Delegation of Authority by Quintiles Czech Republic, s.r.o. located at Praha 5, Jinonice, Radlická 714/113a, zip code 158 00, Czech Republic
SMLOUVA O KLINICKÉ STUDII CLINICAL STUDY AGREEMENTClinical Study Agreement • May 5th, 2020
uzavřená podle § 1746 odst. 2 zákona č. 89/2012 Sb. Občanského zákoníku a § 12 odst. 2 vyhlášky č. 226/2008 Sb., o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, ve znění pozdějších předpisů.
AMENDMENT TO THE CLINICAL STUDY AGREEMENTClinical Study Agreement • February 26th, 2019
First Amendment (the “Amendment”) effective upon execution by all parties to that certain Clinical Study Agreement (the “Agreement”), effective November 13, 2018 between University Hospital Hradec
ContractClinical Study Agreement • March 29th, 2019
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDII This Clinical Study Agreement (“Agreement”) is made and entered into as of the date of its publication in the Register of Agreements in compliance with Act No. 340/2015 Coll., on Register of Agreements. The Parties hereby agree that their mutual rights and obligations will be governed by this Agreement with effects from the date of the last signature hereof (“Effective Date”) by and between, Fakultní nemocnice Olomouc, located at I. P. Pavlova 185/6, 779 00 Olomouc, Czech Republic, Identification number: 00098892, Tax identification number: CZ00098892, represented by prof. MUDr. Roman Havlík, Ph.D., Director (“Study Site”), and Daiichi Sankyo, Inc., located at 211 Mt. Airy Road, Basking Ridge, New Jersey 07920, United States (“DSI”) and IQVIA RDS Czech Republic s.r.o., having a place of business at Pernerova 691/42, 186 00 Praha 8 - Karlín, Czech Republic, Identification number: 247 68 651, Tax identification number: CZ24768651, repres
CLINICAL STUDY AGREEMENT SMLOUVA O KLINICKÉ STUDIIClinical Study Agreement • June 17th, 2022
This Clinical Study Agreement (“Agreement”) is entered into as of the date of last signature hereto (the “Effective Date”) by and between Fakultní nemocnice v Motole, with offices at V Úvalu 84, 15006 Prague 5, Czech Republic, Company ID no. 00064203, Tax ID no. CZ00064203, represented by JUDr. Ing. Miloslav Ludvík, MBA, director, based on appointment dated 27.4.2000 (the “Institution”) and Merrimack Pharmaceuticals, Inc., a Delaware corporation with offices at 1 Kendall Square, suite B7201, Cambridge, MA 02139 (together with its affiliates and subsidiaries, the “Sponsor”), in connection with a clinical trial conducted pursuant to Protocol MM-302-02-02- 03, “A Randomized, Multicenter, Open Label Study of MM-302 plus Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Anthracycline Naive Patients with Locally Advanced/Metastatic HER2- Positive Breast Cancer” (the “Protocol”) (the “Study”). The Study will be conducted under the immediate supervision o
