OBSERVATIONAL STUDY AGREEMENT SMLOUVA O PROVEDENÍOBSERVAČNÍ STUDIE between mezi: IQVIA Ltd. společností IQVIA Ltd. and a and a University Hospital Ostrava Fakultní nemocnicí Ostrava Pfizer Protocol # Č. protokolu společnosti Pfizer C0311015 C0311015...Observational Study Agreement • November 6th, 2023
Contract Type FiledNovember 6th, 2023(“Principal Investigator”), „hlavní zkoušející“), and a University Hospital Ostrava , with a place of business at 17.listopadu 1790, 70852Ostrava -Poruba, Česká republika, IČO: 00843989, DIČ: CZ00843989, deed offoundation MZ CR, dated 25 November 1990, č.j. OP-054- 25.11.90, represented bydeputy for science and research (“Institution”), Fakultní nemocnicí Ostrava, se sídlem na adrese 17. listopadu 1790/5, 708 52 Ostrava-Poruba,Česká republika, IČO: 00843989,DIČ: CZ00843989, zřizovací listina MZ ČR ze dne 25. listopadu 1990, č. j. OP- 054-25.11.90, zastoupenou ,náměstkem ředitele pro vědu, výzkum a výuku (dále jen „zdravotnické zařízení“) when signed by all parties, is effective as of the date of its publishing in theContract Register subject to compliance with the requirement to publish the redacted version of the Agreement in accordance with Section 15.2 (Publication of Redacted Agreement). The expected duration of the Study is from the date of signing this Agreement until end
ContractObservational Study Agreement • January 4th, 2018
Contract Type FiledJanuary 4th, 2018OBSERVATIONAL STUDY AGREEMENT SMLOUVA O OBSERVAČNÍ STUDII This Observational Study Agreement (the “Agreement”), is made and comes into force and effect by signing of all contract parties as of the Effective Date (as defined below), by and among Biogen Idec Research Limited with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen Idec”), Fakultní nemocnice u sv. Anny v Brně, Pekařská 664/53, Brno postcode 656 91, Czech republic , Identification number: 00159816, Tax identification number: CZ00159816, represented by director MUDr. Martin Pavlík, Ph.D., DESA, EDIC, director (the “Institution”), and,Czech Republic (the “Physician”), and Quintiles Czech Republic, s.r.o., Praha 5, Jinonice, Radlická 714/113a,158 00, Czech Republic, Identification Number:: 247 68 651, Tax identification Number:: CZ247 68 651, acting on the basis of Power of Attorney dated 30 June 2014 (the "CRO"). Tato smlouva o observační studii (dále jen „sml
ContractObservational Study Agreement • June 28th, 2018
Contract Type FiledJune 28th, 2018OBSERVATIONAL STUDY AGREEMENT SMLOUVA O OBSERVAČNÍ STUDII Protocol No.: 161302 Č. protokolu: 161302 Phase IV Study Studie fáze IV This Observational Study Agreement (the "Agreement"), effective upon the date of the last signature (“Effective Date”), is entered into by and between Baxalta Innovations GmbH, a corporation organized under the laws of Austria, with primary place of business at Industriestrasse 67, 1220 Vienna, Austria and its affiliate companies ("SPONSOR") and Quintiles Czech Republic, s.r.o., organized under the laws of Czech Republic with a place of business at Praha 5, Jinonice, Radlická 714/113a, zip code 158 00 Prague, Czech Republic, Identification number: 24768 651, Tax identification number: CZ247 68 651 (“SPONSOR Representative”) and T. Bata Regional Hospital, a. s., Identification number 27661989, place of business Havlíčkovo nábřeží 600, 762 75 Zlín, registered in the Business Register maintained by District Court in Brno, Section B, Insert 4437, represented
ContractObservational Study Agreement • July 7th, 2022
Contract Type FiledJuly 7th, 2022CONTRACT between XXXXXXXXXXXX(SPONSOR or CRO), the Institut d’Investigació Bomèdica de Girona (IDIBGI), the Hospital Universitari de Girona Dr. Josep Trueta and the Dr. XXXXXXXXXXXX to carry out the observational study entitled: “……………………….” - (acronym), with code …………………
ContractObservational Study Agreement • July 3rd, 2020
Contract Type FiledJuly 3rd, 2020OBSERVATIONAL STUDY AGREEMENT XXXX Protocol # XXXXX This Observational Study Agreement (“Agreement”) between Value Outcomes s.r.o., a a company established under the laws of the Czech Republic with a place of business at Václavská 316/12, Nové Město (Prague 2), 120 00 Prague, CzechRepublic, Identification Number: 27079333, registered in the Commercial Register maintained by the Municipal Court in Prague, Section C, File 9469 (“CRO”) and Thomayerova nemocnicewith a place of business at Vídeňská 800, 140 59 Praha 4 - Krč, Česká republikaIČO: 00064190 DIČ: CZ00064190state contributory organizations established by the Ministry of Healthcare MZDR 17268-IV/2012, registered in the Commercial Register at the Municipal Court in Prague, section Pr, vl. 1043 represented by: doc. MUDr. Zdeněk Beneš, CSc., Director (“Institution”), and XXXXXXX, with a place of work or business at Vídeňská 800, 140 59 Praha 4 - Krč, Czech republic (“Principal Investigator”), when signed by all parties, is effective
ContractObservational Study Agreement • July 31st, 2019
Contract Type FiledJuly 31st, 2019OBSERVATIONAL STUDY AGREEMENT ZMLUVA O OBSERVAČNEJ ŠTÚDII Protocol # GENA-99 Protokol č. GENA-99 This Observational Study Agreement (“Agreement”) shall enter into force upon signature by all parties and it shall become 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 observačnej štúdii (ďalej len „zmluva“) nadobúda platnosť dňom jej podpísania všetkými zmluvnými stranami a účinnosť dňom nasledujúcim po dni jej zverejnenia v zmysle § 47a ods. 1 zákona č. 40/1964 Zb. Občiansky zákonník v znení neskorších predpisov v centrálnom registri zmlúv na www.
OBSERVATIONAL STUDY AGREEMENT SMLOUVA O PROVÁDĚNÍ OBSERVAČNÍSTUDIE This Observational Study Agreement (the “Agreement”), is made and comes into force and effect by signing of all contract parties, by and between Biogen Idec Research Limited with a...Observational Study Agreement • October 10th, 2016
Contract Type FiledOctober 10th, 2016this Agreement for the sole purpose of making such payments hereunder on behalf of Biogen and the CRO shall have no other rights or obligations under this Agreement. smluvní stranou této Smlouvy, a to výhradně za účelem provádění plateb podle této Smlouvy jménem společnosti Biogen s tím,že CRO nebude mít z této Smlouvy žádná další práva ani povinnosti. NOW, THEREFORE, in consideration of themutual promises and covenants contained herein Biogen, the Physician and the Institution hereby agree as follows: Po zvážení vzájemných příslibů a závazkůuvedených v této Smlouvě se společnost Biogen, Lékař a Zdravotnické zařízení dohodly na uzavření Smlouvy v tomto znění: 1. 1. The Study. Studie. 1.1 1.1 Subject Matter. The Institution and the Physician shall conduct the Study for Biogen pursuant to the protocol entitled “A multicenter, global, retrospective, observational study to characterize real- world clinical outcomes in patients with relapsing-remitting multiple sclerosis treated with diseas
ContractObservational Study Agreement • October 25th, 2017
Contract Type FiledOctober 25th, 2017AMENDMENT NO. 2 TO OBSERVATIONAL STUDY AGREEMENT DODATEK Č. 2 KE SMLOUVĚ O OBSERVAČNÍ STUDII THIS AMENDMENT AGREEMENT NO. 2 ismade effective as of the date of last signature (the “Effective Date”) by and among: TENTO DODATEK KE SMLOUVĚ Č. 2 jeuzavírán s účinností k datu posledního podpisu (dále „Datum účinnosti”) mezi: Biogen Idec Research Limited with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen Idec”), and Biogen Idec Research Limited se sídlem Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, Spojené království, (dále jen „Biogen Idec“), a Nemocnice Jihlava, allowance organization, having a place of business at Vrchlického 59, Jihlava, postcode 586 33, Czech Republic,Identification number: 000 90 638, Tax identification number: CZ00090638, represented by MUDr. Lukáš Velev, MHA, director (the “Institution”) and Nemocnicí Jihlava, příspěvková organizace, se sídlem Vrchlického 59, Jihlava, PSČ 586 33,
ContractObservational Study Agreement • December 29th, 2016
Contract Type FiledDecember 29th, 2016OBSERVATIONAL STUDY AGREEMENT SMLOUVA O PROVÁDĚNÍ OBSERVAČNÍSTUDIE This Observational Study Agreement (the “Agreement”), is made as of the Effective Date (as defined below), by and between Biogen Idec Research Limited with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen”), Nemocnice Pardubického kraje, a.s., located at Kyjevská 44, 532 03 Pardubice, Czech Republic, represented by MUDr. Tomáš Gottvald - Chairperson of the Board of Directors, MUDr. Vladimír Ninger, Ph.D. – Member of the Board of Directors, listed in the Commercial Register at the Municipal Court of Hradec Králové, section B, insert 2629, Company ID no.: 27520536, Tax ID no: CZ27520536 (the “Institution”), MUDr. Alena Novotná, located at Komenského 103, Pardubice530 03, Czech Republic (the “Physician”) and Quintiles Czech Republic, s.r.o., Praha 5, Jinonice, Radlická 714/113a, 158 00, Czech Republic, Identification Number: 247 68 651, Tax identification Num
ContractObservational Study Agreement • February 22nd, 2023
Contract Type FiledFebruary 22nd, 2023OBSERVATIONAL STUDY AGREEMENT SMLOUVA O OBSERVAČNÍ STUDII This Observational Study Agreement (the “Agreement”), is made as of 13 March 2013 (the “Effective Date”), by and among Biogen Idec Research Limited, a company established under the laws of England, with its principal executive offices located at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen Idec”), Fakultní Nemocnice Plzeň, Edvarda Beneše 1128/13, Plzeň 305 99, Czech Republic (the “Provider of health services”), andMS Centrum, Neurologická klinika (the “Physician”). Tato smlouva o observační studii (dále jen „smlouva“) je uzavřena s účinností k 13. březnu 2013 (dále jen „datum účinnosti“), mezi společností Biogen Idec Research Limited, společností založenou dle zákonů Anglie, se sídlem Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, Velká Británie, (dále jen „Biogen Idec“), Fakultní Nemocnicí Plzeň, Edvarda Beneše 1128/13, Plzeň 305 99, Czech Republic (dále jen„
REGISTRY AGREEMENT TO BE PUBLISHEDObservational Study Agreement • January 10th, 2017
Contract Type FiledJanuary 10th, 2017separate agreement with SPONSOR Representative, a contract research organization to set-up and conduct the Study (as defined below) in Czech Republic, including signing this Agreement on behalf of the SPONSOR. The SPONSOR Representative shall represent the SPONSOR in all matters related to performance of the Study on behalf of SPONSOR, and, unless otherwise agreed in the Protocol (enclosed hereto as Exhibit A), all communications between INSTITUTION and SPONSOR regarding the conduct of the Study shall be addressed to or routed directly to the SPONSOR Representative. Zástupcem ZADAVATELE, který je pověřen přípravou a prováděním Studie (definované níže) v České republice, včetně uzavření této Smlouvy jménem ZADAVATELE. Zástupce ZADAVATELE bude zastupovat ZADAVATELE ve všech záležitostech souvisejících s prováděním Studie jménem ZADAVATELE, a pokud nebude v Protokolu (přiloženém k této Smlouvě jako Příloha A) dohodnuto něco jiného, bude veškerá komunikace mezi ZDRAVOTNICKÝM ZAŘÍZENÍM a ZA
OBSERVATIONAL STUDY AGREEMENT ZMLUVA O POZOROVACOM SKÚŠANÍObservational Study Agreement • April 13th, 2015
Contract Type FiledApril 13th, 2015This Observational Study Agreement (the “Agreement”), is made as of the Effective Date (as defined below), by and between Biogen Idec Research Limited, with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen Idec”), and
ContractObservational Study Agreement • September 13th, 2022
Contract Type FiledSeptember 13th, 2022OBSERVATIONAL STUDY AGREEMENT SMLOUVA O SLEDOVACÍ STUDII Protocol # s Sobi.Doptelet-001 Protokol č. Sobi.Doptelet-001 This Observational Study Agreement (“Agreement”) dated as of the date of last signature and effective as of the date of publication of the Redacted Agreement (hereinafter defined) into the Contracts Registry (hereinafter defined) (“Effective Date”) between Tato smlouva o sledovací studii (dále jen„smlouva“) datovaná k datu posledního podpisu a účinná od data uveřejnění upravené smlouvy (definováno níže) v registru smluv (definován níže) (dále jen„datum účinnosti“) se uzavírá mezi Syneos Health UK Limited, with principal offices located at Farnborough Business Park, 1 Pinehurst Road, Farnborough, Hampshire, GU14 7BF, United Kingdom of Great Britain and Northern Ireland, including its affiliates, subsidiaries, and specifically its parent company Syneos Health, LLC (“CRO”) společností Syneos Health UK Limited se sídlem na adrese Farnborough Business Park, 1 Pin
ContractObservational Study Agreement • November 7th, 2016
Contract Type FiledNovember 7th, 2016OBSERVATIONAL STUDY AGREEMENT SMLOUVA O PROVÁDĚNÍ OBSERVAČNÍSTUDIE This Observational Study Agreement (the “Agreement”), is made as of the Effective Date (as defined below), by and between Biogen Idec Research Limited with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen”), Krajská zdravotní a.s., having its place of business at Sociální péče 3316/12A, 401 13 Ústí nad Labem, Czech Republic, Identification number: 254 88 627, Tax identification number: CZ25488627, represented by Ing. Petr Fiala, Director-General (the “Institution”) and Quintiles Czech Republic, s.r.o., Praha 5, Jinonice, Radlická 714/113a, 158 00, Czech Republic, Identification Number: 24768 651, Tax identification Number:CZ24768651 acting on the basis of Power of Attorney dated 28 March 2016 (the "CRO") Tato smlouva o provádění observační studie (dále jen „Smlouva“) je uzavírána k Datu účinnosti (definice viz níže) mezi Biogen Idec Research Limited se síd
ContractObservational Study Agreement • November 9th, 2016
Contract Type FiledNovember 9th, 2016OBSERVATIONAL STUDY AGREEMENT SMLOUVů O PROVÁDENÍ OBSERVůČNÍSTUDIE This Observational Study Agreement (the “Agreement”), is made as of the Effective Date (as defined below), by and between Biogen Idec Research Limited with a place of business at Innovation House, 70, Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom (“Biogen”), Fakultní nemocnice Hradec Králové, having a place of business at Sokolská 581, post code 500 05 Hradec Králové– Nový Hradec Králové, Czech Republic, Identification number: 00179906, Tax identification number: CZ00179906, represented by prof. MUDr. Vladimír Palička, CSc., dr. h. c., Director (the “Provider”),address Neurology Clinic of Fakultní nemocnice Hradec Králové, Sokolská 581, 500 05 Hradec Králové, Czech Republic (the “Investigator”) and Quintiles Czech Republic, s.r.o., Praha 5, Jinonice, Radlická 714/113a, 158 00, Czech Republic, Identification Number: 24768 651, Tax identification Number: CZ247 68 651acting on the basis of Power of Attorney d
SMLOUVA O observační studii OBSERVATIONAL STUDY AGREEMENTObservational Study Agreement • July 16th, 2020
Contract Type FiledJuly 16th, 2020PPD Investigator Services LLC., se sídlem 929 North Front St, Wilmington, NC 28401, USA (dále jen “CRO”) která provádí klinické hodnocení jako nezávislý subjekt ve prospěch farmaceutické firmy Angelini S.p.A., se sílem na Viale Amelia 70, 00181 Řím, Itálie (dále jen „Zadavatel“) PPD Investigator Services LLC., with its registered address at 929 North Front St, Wilmington, NC 28401, USA (hereinafter referred to as the “CRO”) which is conducting as an independent contractor for the benefit of a pharmaceutical company Angelini S.p.A., having its registered offices at Viale Amelia 70, 00181 Rome, Italy (hereinafter referred to as the “Sponsor”)
ContractObservational Study Agreement • April 27th, 2018
Contract Type FiledApril 27th, 2018AMENDMENT NO. 1 TO OBSERVATIONAL STUDYAGREEMENT DODATEK Č. 1 KE SMLOUVĚ O OBSERVAČNÍSTUDII This Amendment No. 1 to Observational Study Agreement (“Amendment No. 1”), effective as 16 March 2018 (the “Effective Date”), is by and among Baxalta Innovations GmbH, having a place of business at Industriestrasse 67, 1220 Vienna, Austria (“Sponsor”), and Krajská NemocniceT. Bati, a.s. organized under the laws of Czech Republic with its principal place of business at Havlíčkovo nábřeží 600, 762 75 Zlín, registered in the District Court in Brno, Section B, Insert 4437, represented by Radomir Maracek, MD., Chief Executive and Ing. Vlastimil Vajdak, member of the Executive board (“Institution”); and(“Principal Investigador”); Tento Dodatek č. 1 ke Smlouvě o observační studii („Dodatek č. 1“), účinný k datu 16. března 2018t(„Datum účinnosti“), uzavírají společnost Baxalta Innovations GmbH, se sídlem Industriestrasse 67, 1220 Vídeň, Rakousko („Zadavatel“) a Krajská Nemocnice T. Bati, a.s., zřízen
DODATEK č.1Observational Study Agreement • September 8th, 2021
Contract Type FiledSeptember 8th, 2021Value Outcomes s.r.o., a company established under the laws of the Czech Republic with a place of business at Václavská 316/12, Nové Město (Prague 2),
ContractObservational Study Agreement • July 23rd, 2024
Contract Type FiledJuly 23rd, 2024