ContractClinical Investigator Agreement • August 2nd, 2017
Contract Type FiledAugust 2nd, 2017CLINICAL INVESTIGATOR AGREEMENT - BIPARTITE SMLOUVA O ZABEZPEČENÍKLINICKÉHO HODNOCENÍ – DVOUSTRANNÁ This Clinical Study Agreement (this “Agreement”) when signed by all parties, will set forth certain agreements by and between Tato Smlouva o provedení a zabezpečení Klinického hodnocení (dále jen„Smlouva“) pokud je podepsaná všemi smluvními stranami nastavuje dohodu mezi PPD Investigator Services LLC,with its registered address at 929 North Front St, Wilmington, NC 28401, USA,Company ID: 46-2919241 ("CRO") PPD Investigator Services LLC,se sídlem 929 North Front St, Wilmington, NC 28401, USAIČO: 46-2919241(dále jen „CRO “), and a Fakultni nemocnice v Motole,state funding organisation, with its registered address at V Uvalu 84, 150 06 Prague 5, Czech Republic, represented by MUDr. Pavel Budinsky, Ph.D., MBA based on authorisation dated 29thNovember 2016 Fakultní nemocnice v Motole,státní příspěvková organizace se sídlem V Úvalu 84, 150 06 Praha 5, Česká republika, zastoupen
CLINICAL INVESTIGATOR AGREEMENT - TRIPARTITEClinical Investigator Agreement • January 14th, 2015
Contract Type FiledJanuary 14th, 2015The Institution and the Investigator are hereinafter called “Institution/Investigator” when it is intended that they be referred to jointly.
ContractClinical Investigator Agreement • January 23rd, 2017
Contract Type FiledJanuary 23rd, 2017CLINICAL INVESTIGATOR AGREEMENT - TRIPARTITE SMLOUVA O ZABEZPEČENÍ A PROVEDENÍ KLINICKÉHO HODNOCENÍ– TROJSTRANNÁ This Agreement (“Agreement”) is becomes effective on the day of signature by all contractual parties (hereinafter the ‘Effective Date”) and is entered into, by and between ICON Clinical Research Limited(hereinafter called “ICON”) with a vat number IE 8201978R,Company no.: 201978and a place of business at South County Business Park, Leopardstown, Dublin 18, Ireland, and Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje with a place of business at Kolín, Žižkova 146, PSČ 28000Company no.: 27256391 Represented by: MUDr. Peter Chudomel MBA (hereinafter called the “Institution”) andXXXDate of birth: XXX Address: XXX Tato smlouva (dále jen „smlouva“) vstupuje v platnost dnem jejího podpisu všemi smluvními stranami (dále jen „datum účinnosti“) a uzavírají ji mezi sebou společnost ICON Clinical Research Limited(dále jen „společnost ICON“)DIČ: IE 8201978R, IČO:
ContractClinical Investigator Agreement • March 29th, 2017
Contract Type FiledMarch 29th, 2017AMENDMENT No. 2 DODATEK č. 2 TO CLINICAL INVESTIGATOR AGREEMENT KE SMLOUVĚ O ZABEZPEČENÍ KLINICKÉHO HODNECENÍ This Agreement Amendment No. 2(“Amendment”) is made and entered into effective as of the date …………………. (hereinafter called “Effective date”) Tento dodatek č. 2 ke smlouvě (dále jen “dodatek”) byl uzavřen a vstupil v platnost dne ………………….. (dále jen “datum platnosti”) by and between mezi ICON Clinical Research Limitedwith a VAT number IE 8201978Rand a place of business at South County Business Park, Leopardstown, Dublin 18, Ireland,represented by XXXXXXXXXClinical Operations Manager (hereinafter called “ICON”) ICON Clinical Research LimitedDIČIE 8201978R,se sídlem vSouth County Business Park, Leopardstown, Dublin 18, Irsko,zastoupená XXXXXXXXXClinical Operations Manager (dále jen „ICON“), and a Falultni nemocnice Plzenwith a VAT number CZ 00669806with a place of business at Edvarda Benese 1128/13, 305 99 Plzen,Czech Republic, represented byMUDr. Vaclav Simanek, Ph.D. managing
ContractClinical Investigator Agreement • March 20th, 2024
Contract Type FiledMarch 20th, 2024WHEREAS: VZHLEDEM K TOMU, ŽE: (A) The Parties entered into a Clinical Investigator Agreement dated 24 November 2014 (hereinafter referred to as the “Agreement”) with regard to the clinical trial “A multinational, randomised, double-blind, placebo-controlled, Phase III efficacy and safety study of ODM-201 in men with high- risk non-metastatic castration-resistant prostate cancer” (“Study”), (A) smluvní strany uzavřely Smlouvu o zabezpečení a provedení klinického hodnocení dne 24. listopadu 2014 (dále jen„smlouva“) týkající se klinického hodnocení s názvem „Mezinárodní, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze III hodnotící účinnost a bezpečnost přípravku ODM-201 u mužů ohrožených vysokým rizikem nemetastázujícího kastračně rezistentního karcinomu prostaty“ (dále jen „studie“), (B) Bayer has contracted CRO to provide services to facilitate the conduct of the Study, including without limitation authorizing CRO to sign this amendment of the Agreement (hereinafter
ContractClinical Investigator Agreement • December 20th, 2016
Contract Type FiledDecember 20th, 2016CLINICAL INVESTIGATOR AGREEMENT - TRIPARTITE SMLOUVA O ZABEZPEČENÍ A PROVEDENÍ KLINICKÉHO HODNOCENÍ - TROJSTRANNÁ This Agreement (“AGREEMENT”) is entered TATO SMLOUVA (dále jen „SMLOUVA“) se into this ……………….. uzavírá dne …………………. BY AND BETWEEN MEZI ICON Clinical Research Limitedwith a VAT number IE 8201978Rand a place of business atSouth County Business Park, Leopardstown, Dublin 18, Ireland,represented by XXXXXXXXXXXXSr. Director Project Management (hereinafter called “ICON”) ICON Clinical Research LimitedDIČIE 8201978R,se sídlemSouth County Business Park, Leopardstown, Dublin 18, Irsko,zastoupený XXXXXXXXXXXXSr. Director Project Management (dále jen „ICON“), AND A Fakultni nemocnice Brnowith a VAT number CZ 65269705with a place of business at Jihlavska 20, 625 00 Brno, Czech Republic, represented byMUDr. Roman Kraus, MBA managing director(hereinafter called the “Institution”) Fakultní nemocnice BrnoDIČ CZ65269705se sídlem Jihlavská 20, 625 00 Brno,Česká republika, jednajícíMUDr
ContractClinical Investigator Agreement • December 7th, 2016
Contract Type FiledDecember 7th, 2016AMENDMENT No. 1 DODATEK č. 1 TO CLINICAL INVESTIGATOR AGREEMENT KE SMLOUVĚ O ZABEZPEČENÍ KLINICKÉHO HODNECENÍ This Agreement Amendment no. 1(“Amendment”) is made and entered into effective as of the date …………………. (hereinafter called “Effective date”) Tento dodatek č. 1 ke smlouvě (dále jen “dodatek”) byl uzavřen a vstoupil v platnost dne ………………….. (dále jen “datum platnosti”) by and between mezi ICON Clinical Research Limitedwith a VAT number IE 8201978Rand a place of business at South County Business Park, Leopardstown, Dublin 18, Ireland,represented by XXXXXXXXXXXXSr.Director Project Management (hereinafter called “ICON”) ICON Clinical Research LimitedDIČ IE 8201978R,se sídlem vSouth County Business Park, Leopardstown, Dublin 18, Irsko,zastoupený XXXXXXXXXXSr. Director Project Management (dále jen „ICON“), and a Falultni nemocnice Plzenwith a VAT number CZ 00669806with a place of business at Edvarda Benese 1128/13, 305 99 Plzen,Czech Republic, represented byMUDr. Vaclav Simanek, Ph.D
ContractClinical Investigator Agreement • December 7th, 2016
Contract Type FiledDecember 7th, 2016CLINICAL INVESTIGATOR AGREEMENT - TRIPARTITE SMLOUVA A ZABEZPEČENÍ A PROVEDENÍ KLINICKÉHO HODNOCENÍ - TROJSTRANNÁ This Agreement (“AGREEMENT”) is entered Tato smlouva (dále jen „SMLOUVA“) se into this …………………. uzavírá dne ......................... BY AND BETWEEN MEZI ICON Clinical Research Limitedwith a VAT number IE 8201978Rand a place of business atSouth County Business Park, Leopardstown, Dublin 18, Ireland,represented by XXXXXXXXXXXXXXSr. Director Project Management (hereinafter called “ICON”) ICON Clinical Research LimitedDIČIE 8201978R,se sídlemSouth County Business Park, Leopardstown, Dublin 18, Irsko,zastoupený XXXXXXXXXXXXSr. Director Project Management (dále jen „ICON“), AND A Falultni nemocnice Plzenwith a VAT number CZ 00669806with a place of business at Edvarda Benese 1128/13, 305 99 Plzen,Czech Republic, represented byMUDr. Vaclav Simanek, Ph.D. managing director(hereinafter called the “Health Service Provider”) Fakultní nemocnice PlzeňDIČCZ 00669806se sídlem Edvarda
ContractClinical Investigator Agreement • March 15th, 2018
Contract Type FiledMarch 15th, 2018Dodatek 1 keSmlouvě o zabezpečení klinického hodnocení TROJSTRANNÁ č. 08/OVZ/17/015-P Amendment 1 toCLINICAL INVESTIGATOR AGREEMENT - TRIPARTITE no. 08/OVZ/17/015-P Tento dodatek 1 ke smlouvě o zabezpečení klinického hodnocení („dodatek 1“) mezi: This Amendment 1 to CLINICAL INVESTIGATOR Agreement (“Amendment 1”) between: PPD Investigator Services LLC.,se sídlem 929 North Front St, Wilmington, NC 28401, USA(“CRO”) PPD Investigator Services LLC.,with its registered address at 929 North Front St,Wilmington, NC 28401, USA (“CRO”) a and Fakultní nemocnice Ostrava, se sídlem 17. listopadu 1790/5, 708 52 Ostrava - Poruba, Česká republika, ve věcech této smlouvy oprávněn jednat a podepisovat: MUDr. Josef Srovnal, náměstek ředitele pro léčebnou péči. Zřizovací listina MZ ČR ze dne 25. listopadu 1990 č.j. OP-054-25.11.90IČ: 00843989 DIČ: CZ00843989(„Zdravotnické zařízení“) Fakultni nemocnice Ostrava, registered address at 17. listopadu 1790/5, 708 52 Ostrava, Czech Republic, entitled to act a
ContractClinical Investigator Agreement • March 6th, 2019
Contract Type FiledMarch 6th, 2019CLINICAL INVESTIGATOR AGREEMENT- TRIPARTITE SMLOUVA SE O PROVEDENÍ KLINICKÉHO HODNOCENÍ – TROJSTRANNÁ This Agreement (“Agreement ”) is entered TATO SMLOUVA (dále jen „Smlouva“) se uzavírá by and between Mezi ICON Clinical Research Limitedwith a VAT number IE 8201978R and a place of business at South County Business Park, Leopardstown, Dublin 18, Ireland, represented byXXXXXXXXXX,Sr. Clinical Operations Manager (hereinafter called “ICON”) ICON Clinical Research LimitedDIČ IE 8201978R,se sídlem South County Business Park,Leopardstown, Dublin 18, Irsko zastoupenáXXXXXXXXXX,Sr. Clinical Operations Manager (dále jen „ICON“) And A Fakultní nemocnicí Královské Vinohrady,Company ID: 0006417/3, VAT Number: CZ00064173,With a place of business at Šrobárova 1150/50, 100 34 Praha 10, Czech Republic, represented by Doc. MUDr. Robert Grill, Ph.D., MHA,, Director, ref. No.: KH 39/2018, cost center: 43038(hereinafter called the “Institution”) Fakultní nemocnicí Královské Vinohrady,IČ: 0006417/3
ContractClinical Investigator Agreement • December 27th, 2016
Contract Type FiledDecember 27th, 2016CLINICAL INVESTIGATOR AGREEMENT- TRIPARTITE SMLOUVA O ZABEZPEČENÍ A PROVEDENÍ KLINICKÉHO HODNOCENÍ – TROJSTRANNÁ This Agreement (“AGREEMENT”) is entered into this August 30 2012, by and between ICON Clinical Research Limited (hereinafter called “ICON”) with a VAT number xxx and a place of business at South County Business Park, Leopardstown, Dublin 18, Ireland Tato Smlouva (dále jen „Smlouva“) se uzavírá dne 30.8.2012 mezi společností ICON Clinical Research Limited (dále jen „ICON“), xxx, se sídlem v South County Business Park, Leopardstown, Dublin 18, Irsko and a Hospital Na Bulovce with a place of business at Budinova 2, 180 81 Prague 8, Czech Republic xxx (hereinafter called the “Institution”) Nemocnicí Na Bulovce, Budínova 2, 180 81 Praha 8, zastoupenou xxx (dále jen„ZDRAVOTNICKÉ ZAŘÍZENÍ“) and a xxx with a place of business at FN Na Bulovce, Institute of Pneumology and chest surgery, Budinova 2, 180 81 Prague 8, Czech Republic (hereinafter called the “Investigator”). xxx, s vý