NON-INTERVENTIONAL STUDY AGREEMENTNon-Interventional Study Agreement • May 16th, 2023
This non-interventional study agreement (“Agreement”) is entered into as the last date of the signature below (“Effective Date”) between
The information set out below provides a checklist of information that needs to be included in the model Non-Interventional Study Agreement (mNISA) in preparation for execution by the Parties. It is the Sponsor’s responsibility to provide the required...Non-Interventional Study Agreement • December 13th, 2023
Add, remove and / or update recitals as applicable to the Non-Interventional Study (as a preamble to the Agreement, such changes do not constitute modification to the template Agreement). Recital D should be completed where a corporate Affiliate of the Sponsor is formally empowered by the Sponsor to sign the Agreement on behalf of the Sponsor thereby binding the Sponsor as Party to the Agreement (and should be removed where this is not the case). Recital E should be retained if the Participating Organisation is in Northern Ireland and otherwise deleted.
ContractNon-Interventional Study Agreement • May 28th, 2021
Takeda Sponsored Non-Interventional (Observational) Study Agreement Smlouva o provádění neintervenční (observační) studie, jejímž zadavatelem je společnost Takeda A Prospective, Multicenter Registry for Patients with Short Bowel Syndrome Prospektivní multicentrický registr pro pacienty se syndromem krátkého střeva Takeda SBS Protocol No TED-R13-002 Protokol SBS společnosti Takeda, č. protokolu TED-R13-002 THIS SPONSORED NON-INTERVENTIONAL (OBSERVATIONAL) STUDY AGREEMENT(the “Agreement”) is made by and among IQVIA RDS Switzerland Sarl, a clinical research organization having a place of business at Route de Pallatex 29, 1162 St-Prex, Switzerland acting through its Legal representative, or when applicable, with National ID number nº411658CE, or nº 771656RA (“CRO”), Thomayer University Hospital, having a place of business at Vídeňská 800, 140 59 Praha 4, Czech Republic, ID: 00064190, Tax ID: CZ00064190, represented by the director , entered in theBusiness Registry maintained by the M
ContractNon-Interventional Study Agreement • March 22nd, 2019
English Czech Tripartite Institution – Investigator - CRO Template Šablona třístranné smlouvy mezi zdravotnickým zařízením, zkoušejícím a CRO NON-INTERVENTIONAL STUDY AGREEMENT SMLOUVA O NEINTERVENČNÍM KLINICKÉM HODNOCENÍ THIS AGREEMENT (hereinafter the “Agreement”) is valid on and effective date of publication in the register of contracts (“Effective Date”). Tato smlouva (dále jen „smlouva“) nabývá platnosti a účinnosti dnem zveřejnění v registru smluv („datum účinnosti”). Between Mezi stranami Mapi Life Sciences UK Limited, a company organized and existing under the laws of United Kingdom of Great Britain and Northern Ireland, located at Concept House, 6 Stoneycroft Rise, Chandlers Ford, Eastleigh, Hampshire, SO53 3LD United Kingdom of Great Britain and Northern Ireland, VAT number GB 193 9420 80, represented by in his capacity as, duly authorized for the purpose of this Agreement, MAPI Life Science UK Limited, společnost zřízená a působící podle zákonů Spojeného království Velké B
ContractNon-Interventional Study Agreement • August 10th, 2016
AGREEMENT FOR CONDUCT OF NON- INTERVENTIONAL STUDY SMLOUVA O PROVEDENÍ NEINTERVENČNÍ STUDIE This AGREEMENT (the “Agreement”) is effective on date of last signature hereof (the “Effective Date”), by and between: Pharmaceutical Research Associates CZ, s.r.o. located at Jankovcova 1569/2c, 170 00, Praha 7, Czech Republic, company ID number: 276 36 852, TAX ID number: CZ276 36 852,represented by MUDr. Andrea Klč, proxy (“PRA”) acting as an independent contractor for B. Braun Melsungen AG, located at Carl-Braun-Str. 1, 34212, Melsungen, Germany (the “Sponsor”), andFakultní nemocnice Brno located at Jihlavská 20, Brno, 625 00, Czech Republic, company ID number: 65269705, Tax ID number: CZ65269705, represented by MUDr. Roman Kraus, MBA, director (the “Institution”) andMUDr. Igor Sas, with resident address at, Czech Republic, Head of Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, an employee of the Institution acting within the scope of his/her employment, shall serve as th
ContractNon-Interventional Study Agreement • March 22nd, 2022
Takeda Sponsored Non-Interventional (Observational)Study Agreement Smlouva o neintervenční (observační) studii, jejímžzadavatelem je společnost Takeda SPOTLITE: ProSPective ObservaTionaL Study on the Clinical Outcomes of Surgical InTErventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF) SPOTLITE: Prospektivní observační studie klinických výsledků chirurgických zákroků při komplexníchfistulizujících onemocněních (CPF-CD, CD-RVF, CCF) Takeda Protocol No. Alofisel-5007 Č. protokolu společnosti Takeda Alofisel-5007 THIS SPONSORED NON-INTERVENTIONAL (OBSERVATIONAL) STUDY AGREEMENT (the“Agreement”) is made as of of the last date of signature (“Date of Final Signature”) and effective as set out in Section 24 below, by and among IQVIA RDS AG, Branch St-Prex, a clinical research organization with a registered address at Route de Pallatex 29, 1162 St-Prex, Switzerland, VAT: CHE-106.402.567, acting through its Legal representativewith D.N.I. (Documento Nacional de
THIS CONTRACT IS ENTERED INTO BY AND BETWEENNon-Interventional Study Agreement • August 10th, 2020 • Madrid
Of the one part, Mr/Ms/Mrs …and Mr/Ms/Mrs …, with Tax Identity Number ..... acting respectively on behalf and in representation of … (hereinafter the SPONSOR), with Tax Identity Code … and registered address … , duly authorized to execute this document by virtue of a deed of power of attorney duly registered with the Companies Register of _________, authorized by the Notary Public Mr/Ms/Mrs_______________, of the Notary Association of _________ on ___________ (date), number ____ of his/her records, with VAT number ___________,
ZMLUVA O NEINTERVENČNEJ ŠTÚDIINon-Interventional Study Agreement • January 22nd, 2019
AGREEMENT (the “Agreement”) is effective on the day following its publication in the Central Register of Contracts (the “Effective Date”), by and between:
ContractNon Interventional Study Agreement • December 22nd, 2017
ASSIGNMENTand AMENDMENT 2 TO POSTOUPENÍa DODATEK 2KE NON INTERVENTIONAL STUDY AGREEMENT SMLOUVĚ O NEINTERVENČNÍ STUDII This Assignment and Amendment 2 (the “Assignment and Amendment 2”) to the Non Interventional Study Agreement on the Implementation of the TYSABRI® Observational Program (TOP) is made as of the last date of signature (the “Amendment Effective Date”), by and between: Toto postoupení a dodatek 2 (dále jen„postoupení a dodatek 2“) ke smlouvě o neintervenční studii o provádění Observačního programu TYSABRI® (TOP) je učiněn k datu posledního podpisu (dále jen „datum účinnosti dodatku“) mezi: Biogen International GmbH, a corporation established under the laws of Switzerland, with its principal executive offices located at Landis & Gyr Strasse 3, 6300 Zug, Switzerland (“ Biogen International or Outgoing Sponsor”), acting through its authorized representative společností Biogen International GmbH, založenou dle švýcarských zákonů, se sídlem na adrese Landis & Gyr Strasse 3, 63
English CzechNon-Interventional Study Agreement • January 22nd, 2019
Bipartite Institution – CRO Template NON-INTERVENTIONAL STUDY AGREEMENT THIS AGREEMENT (hereinafter referred to as “Agreement”) is effective on the day it is published on the Register of Contracts website (“Effective Date”). By and Between Mapi Life Sciences UK Limited, a company organized and existing under the laws of United Kingdom, located at Concept House, 6 Stoneycroft Rise, Chandlers Ford, Eastleigh, Hampshire, SO53 3LD United Kingdom, VAT number GB 193 9420 80, represented by Isaac Blanco Leis in his capacity as Global Head, Operations Support Management, duly authorized for the purposes of this Agreement, (hereinafter referred to as “CRO”), acting on behalf of IPSEN PHARMA S.A.S., (hereinafter referred to as “Ipsen” or “Sponsor”), and Nemocnice Na Bulovce located at Budinova 67/2, 180, Prague-Liben, represented by MUDr. Lívia Večeřová, MBA, Deputy Director for Science, Research, Grant Activities and Development, according to credentials, (hereinafter re
ContractNon-Interventional Study Agreement • July 17th, 2018
NON INTERVENTIONAL STUDY AGREEMENT SMLOUVA O NEINTERVENČNÍ STUDII This NON INTERVENTIONAL STUDY Agreement (hereafter the “Agreement”) is made this........................ and entered into by and between Hospira UK Limited of Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, England (hereafter the “Sponsor”), represented by UBC Late Stage (UK) Limited located at 26-28 Hammersmith Grove, W6 7HA London, United Kingdom together with its Affiliates (hereafter collectively referred to as “UBC”), in relation to Sponsor’s Inflectra (“STUDY Product”), with UBC acting as agent pursuant to a letter of authorization between the Sponsor and UBC dated 6th November 2014, Tato smlouva o NEINTERVENČNÍ STUDII (dále jen „smlouva“) se uzavírá dne ............................mezi společností Hospira UK Limited of Queensway, se sídlem v Royal Leamington Spa, Warwickshire CV31 3RW, Anglie (dále jen„zadavatel“), zastoupenou společností UBC Late Stage (UK) Limited, se sídlem na adrese 26-28 Hammersmith G
ContractNon-Interventional Study Agreement • July 17th, 2018
AMENDMENT NO 1 TO NON INTERVENTIONAL STUDY AGREEMENT DODATEK Č. 1 KE SMLOUVĚ O NEINTERVENČNÍ STUDII This Amendment number 1 (“Amendment No. 1”), effective as from the date of publication of Amendment No. 1 in the Register of Contracts, but the Parties have agreed that this Amendment is followed from when both the relevant country regulatory authority and site ethics committee have approved amended protocol V 3.0, dated 6 October 2017, is made pursuant to the Agreement dated 23rd Apr 2015 (“Agreement”), by and between Hospira UK Limited of Horizon Building, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom (hereafter the “Sponsor”), acting by UBC Late Stage (UK) Limited, with place of business at 26-28 Hammersmith Grove, W6 7HA London, United Kingdom, together with its Affiliates (hereafter collectively referred to as “UBC”), with UBC acting as agent in the name and on behalf of the Sponsor pursuant to a letter of authorization between the Sponsor and UBC dated 6th Nov 2014 (th
NON-INTERVENTIONAL STUDY AGREEMENTNon-Interventional Study Agreement • January 25th, 2018
Thomayerova nemocnice located at Vídeňská 800, 140 59 Praha 4 – Krč, Czech Republic, IČ (company ID number): 00064190, VAT no.: CZ00064190, established by the Ministry of Health and registered under founding charter OP-054- 25.11.90, represented by Doc. MUDr. Zdeněk Beneš, CSc., director (the “Institution”),
ContractNon-Interventional Study Agreement • February 9th, 2024
Non-Interventional Study Agreement Smlouva o neintervenční klinické studii The Non-Interventional Study Agreement (“Agreement”) is made by and between: Tato Smlouva o neintervenční klinické studii (dále jen „Smlouva“) se uzavírá mezi: • Faculty of Hospital Ostrava having a place of business at 17. Listopadu 1790/5, 708 52 Ostrava-Poruba, Czech Republic, Identification number: 00843989, Tax identification number:CZ 00843989 represented (the “Institution”), contract registration number: 017/OVZ/23/069-P, variable symbol: 649071541, and • Fakultni nemocnice Ostrava, se sídlem 17. listopadu 1790/5, 708 52 Ostrava-Poruba, Česká republika, Identifikační číslo: 00843989, Daňové identifikační číslo: CZ 00843989 ve věcech této smlouvy je oprávněn jednat a podepisovat: . ř(„Zdravotnické zařízení“) evidenční číslo smlouvy: 017/OVZ/23/069-P, variabilní symbol: 649071541, a • having an address atwith the workplace at the Centre for Diagnosis and Treatment of Demyelinating Diseases, Neurology
ContractNon-Interventional Study Agreement • July 9th, 2018
NON INTERVENTIONAL STUDY AGREEMENT This NON INTERVENTIONAL STUDY Agreement (hereafter the “Agreement”) is made this 23 June 2015 and entered into by and between Hospira UK Limited of Horizon Building, Honey Lane, Hurley, Maidenhead SL6 6RJ, England (hereafter the “Sponsor”), represented by UBC Late Stage (UK) Limited located at 26-28 Hammersmith Grove, W6 7HA London, United Kingdom together (hereafter referred to as “UBC”), in relation to Sponsor’s Inflectra (“STUDY Product”), with UBC acting as agent pursuant to a letter of authorization between the Sponsor and UBC dated 6th November 2014 (the “Letter of Authorization”), And The institution Nemocnice Na Bulovce, Gastroenterologická ambulance, I. interní oddělení, Budínova 2, 180 81 Praha 8, Czech Republic VAT no: CZ00064211 and Tax no: 00064211 herewith represented by Tomas Podlesak, MD, Deputy for medical and preventive care, on the basis of delegation (hereafter the “Institution”) With the Institution and the Sponsor being
THE INTOXICATE (ex-TOXIC-EUROPE) STUDY Non-interventional Study AgreementNon-Interventional Study Agreement • August 11th, 2021
University Medical Center Utrecht, Division of Anesthesiology, Intensive Care and Emergency Medicine, whose registered office is at Heidelberglaan 100, 3584 CX Utrecht, The Netherlands, lawfully represented by Drs. S. Vernie, Division Manager and Prof. dr. A.M.G.A. de Smet, Medical Scientific Manager
ContractNon-Interventional Study Agreement • December 29th, 2023
NON-INTERVENTIONAL STUDY AGREEMENT SMLOUVA O NEINTERVENČNÍ STUDII This NON-INTERVENTIONAL STUDYAGREEMENT (the “Agreement”) is effective on the day of publishing in accordance with the Act No. 340/2015 Coll. On the Register of Contracts, as amended (the “Effective Date”), by and between: Masarykův onkologický ústav located at Žlutý kopec 7, 656 53 Brno, Czech Republic, IČ (company ID): 00209805, DIČ (VAT ID):CZ00209805, represented by prof. MUDr. Marek Svoboda, Ph.D., director (the “Institution”), and Pharmaceutical Research Associates CZ, s.r.o., located at Praha 7, Jankovcova 1569/2c, 170 00, Czech Republic, IČ (company ID number): 27636852, the limited liability company duly registered in the Commercial Register of the Czech Republic maintained by the Municipal Court in Prague, Section C, Entry 120574, represented by, authorized representative based on power of attorney (“PRA”), an affiliate of PHARMACEUTICAL RESEARCHASSOCIATES INC., located at 4130 ParkLake Avenue, Suite 400, Raleig
Contract Research Organisation Model Non-Interventional Study Agreement (CRO- mNISA)Non-Interventional Study Agreement • December 13th, 2023
The information set out below provides a checklist of information that needs to be included in the Contract Research Organisation model Non-Interventional Study Agreement (CRO-mNISA) in preparation for execution by the Parties.
NON-INTERVENTIONAL STUDY AGREEMENT no.Non-Interventional Study Agreement • January 18th, 2018
AGREEMENT (the “Agreement”) is effective on the day of the publishing in accordance with the Act no. 340/2015 Coll. On the Register of Contracts (the “Effective Date”), by and between Fakultní nemocnice Ostrava, located at 17. listopadu 1790, 708 52 Ostrava, Czech Republic, Organization ID No.: 00843989, VAT Reg. No.: CZ00843989, person authorized to act and sign in respect of this Agreement: MUDr. Josef Srovnal, Deputy Director for Medical Care, (the “Institution”), Pharmaceutical Research Associates CZ, s.r.o., located at Praha 7, Jankovcova 1569/2c, Post Code (PSČ): 170 00, Czech Republic, IČ (company ID number): 27636852, the limited liability company duly registered in the Commercial Register of the Czech Republic maintained by the Municipal Court in Prague, Section C, Entry 120574, represented by MUDr. Andrea Klč, Proxy (“PRA”), acting as an independent contractor for Baxter R&D Europe SPRL located at Boulevard d´Angleterre, 2-4, Braine l´Alleud, 1420, Belgium (the “Sponsor”) and
ContractNon-Interventional Study Agreement • August 1st, 2024
Takeda Sponsored Non-Interventional (Observational) Study Agreement Smlouva o neintervenční (observační) studii, jejímž zadavatelem je společnost Takeda
ContractNon-Interventional Study Agreement • February 15th, 2017
Non-interventional study Agreement Smlouva o provedení neintervenční studie This Non-interventional study agreement with Institution (hereinafter this “Agreement”) dated is made between: - TFS Trial Form Support, s.r.o., with registered office Klimentská 1216/46, 110 02 Praha 1, Czech Republic, ID:27876756, VAT: CZ27876756,represented by Mr. Pieter van der Meer, Director Finance, TFS West & East Europe, hereinafter “TFS” on behalf of Sponsor Angelini S.p.A., having residence at Viale Amila, 70 00181 Roma, Italy, hereinafter “Sponsor”, on basis of an agreement. and - Fakultní nemocnice Královské Vinohrady, ID: 00064173, VAT: CZ00064173, registered office Šrobárova 1150/50, 100 34 Praha 10, Czech Republic, represented by ass. prof. MUDr. Robert Grill, Ph.D., MHA, director, ref. no. KH 65/2016, a cost center: 29060, hereafter “Institution” Tato smlouva se zdravotnickým zařízením o provedení neintervenční studie (dále pouze „smlouva“), datovaná , se uzavírá mezi těmito stranami: - TFS Tr
Takeda Sponsored Non-Interventional (Observational) Study Agreement Smlouva o neintervenční (observační) studii, jejímž zadavatelem je společnost Takeda SPOTLITE: ProSPective ObservaTionaL Study on the Clinical Outcomes of Surgical InTErventions in...Non-Interventional Study Agreement • November 23rd, 2021
THIS SPONSORED NON-INTERVENTIONAL (OBSERVTIONAL) STUDY AGREEMENT (the “Agreement”) is made as of the last date of signature (“Date of Final Signature”) and effective as set out in Section 24 below, by and among IQVIA RDS AG, Branch St-Prex, a clinical research organization having a place of business at Route de Pallatex 29, 1162 St-Prex, Switzerland, VAT: CHE-106.402.567, acting through its Legal representative XXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXX (“CRO”), Fakultní nemocnice Olomouc having a place of business at I. P. Pavlova 185/6, 779 00 Olomouc, Czech Republic, Identification number: 00098892, Tax identification number: CZ00098892, represented by XXXXXXXXXXXXXXX XXXXXXXXXXXXX (“Institution”) and XXXXXXXXXXXXXXXXXXXXXXXXXX XXXXX, having an address at Fakultní nemocnice Olomouc, I. P. Pavlova 185/6, 779 00 Olomouc, Czech Republic, born on 18.05.1976 (the “Investigator” and together with the Institution, the “Site”). For purposes of this Agreement, each of CRO and the Site may be referred
AGREEMENT FOR CONDUCT OF NON- INTERVENTIONAL STUDYNon-Interventional Study Agreement • January 10th, 2020
PAREXEL International (IRL) Limited having a place of business at 70 Sir John Rogerson’s Quay, Dublin 2, Ireland, Company number 541507, Irish VAT Number: IE 3249971HH (hereinafter “CRO”);
Institution’s Agreement AC-065 A401 EXPOSURE / Smlouva se zdravotnickým zařízením, AC-065 A401 EXPOSURENon-Interventional Study Agreement • November 18th, 2020
INSTITUTION is prepared to participate in the following ACTELION sponsored non-interventional, post-authorization safety study with regard to Uptravi® / PAH under protocol AC-065A401 and titled : ZDRAVOTNICKÉ ZAŘÍZENÍ je připraveno zúčastnit se dále uvedené neintervenční poregistrační studie bezpečnosti týkající se přípravku Uptravi® / PAH v rámci protokolu AC-065A401, jejímž zadavatelem je společnost ACTELION. Studie se nazývá:
ContractNon-Interventional Study Agreement • February 20th, 2017
Non- interventional study Agreement Smlouva o provedení neintervenční studie This non-interventional study Agreement (“Agreement”) is made by and between: Tato smlouva o provedení neintervenční studie („smlouva“) se uzavírá mezi: TFS Trial Form Support, s.r.o., with registered office Klimentská 1216/46, 110 02 Praha 1, Czech Republic, ID: 27876756, VAT: CZ27876756, hereinafter “TFS”. - TFS Trial Form Support s.r.o., se sídlem na adrese Klimentská 1216/46, 110 02 Praha 1, Česká republika, IČO: 27876756, DIČ: CZ27876756, dále jen„TFS“. and a - Fakultni nemocnice Brno, Jihlavska 20, 625 00 Brno, Czech Republic, ID No.: 65269705, Tax ID: CZ65269705,represented by: MUDr. Roman Kraus, MBA – director, hereafter “Institution”. - Fakultní nemocnice Brno, Jihlavská 20, 625 00 Brno, Česká republika, IČ : 65269705, DIČ : CZ65269705,jednající : MUDr. Roman Kraus, MBA - ředitel, dále jen „zdravotnické zařízení“. and a - Prof. MUDr. Petr Husa, CSc.,t,, physician at Clinic of infectious diseases,
