ContractObservational Study Agreement • January 4th, 2018
OBSERVATIONAL 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 • July 31st, 2019
OBSERVATIONAL 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
this 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 • December 29th, 2016
OBSERVATIONAL 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
REGISTRY AGREEMENT TO BE PUBLISHEDObservational Study Agreement • January 10th, 2017
separate 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
ContractObservational Study Agreement • November 7th, 2016
OBSERVATIONAL 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
OBSERVATIONAL 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
