Performance of the Study. 2.1 Institution shall perform the Study substantially in accordance with the protocol and the terms and conditions of this Agreement. Sponsor and Institution may at any time amend the Study and this Agreement by mutual written consent.
Performance of the Study. The Protocol shall be considered final following approval by the IRBs/IECs (and by the Regulatory Authority if required by Applicable Laws). Institution will perform, and ensure that Institution Personnel will perform the Study in a timely manner in strict accordance with the Protocol, Applicable Laws, written instructions of the Sponsor or CRO and the terms and conditions of this Agreement including, but not limited to the Payment Terms and Budget attached hereto as Exhibit A, and any other attachments hereto. In the event of a conflict between the Protocol and this Agreement, the terms and conditions of the Protocol will prevail with respect to scientific issues relating to the Study. In all other instances, the terms and conditions of the Agreement will prevail. Institution agrees that if Investigator has not Enrolled at least one (1) Subject by the Key Enrollment Date, CRO (at the direction and authorization of Sponsor) may terminate this Agreement in accordance with Section 18.2. 2. Provádění studie 2.1. Provádění studie. Protokol bude považován za konečný po schválení IRB/NEK (a regulačním úřadem, pokud to vyžadují platné zákony). Zdravotnické zařízení studii provede, a zajistí, aby tak činil i personál zdravotnického zařízení, včas a v přísném souladu s protokolem, platnými právními předpisy, písemnými pokyny zadavatele nebo CRO a podmínkami této smlouvy, mimo jiné včetně platebních podmínek a rozpočtu, které jsou k této smlouvě připojeny jako příloha A, a veškerých dalších příloh této smlouvy. V případě rozporu mezi protokolem a touto smlouvou mají přednost podmínky protokolu, pokud jde o vědecké otázky související se studií. Ve všech ostatních případech mají přednost podmínky této smlouvy. Zdravotnické zařízení souhlasí s tím, že pokud zkoušející lékař nezařadí do rozhodného termínu pro nábor alespoň jeden (1) subjekt, smí CRO (na pokyn a z pověření zadavatele) tuto smlouvu ukončit v souladu s bodem 18.2 smlouvy.
Performance of the Study. The Study shall commence as soon as practicable after the Effective Date and shall be performed at various sites in the TDN and at various sites outside the TDN if it is deemed necessary by H-E, utilizing the TDN’s oversight services, in accordance with (i) the draft summary work plan developed and agreed to by the Parties (the “Work Plan”), * Confidential Treatment Requested as amended, from time to time, upon the mutual agreement of the Parties, and (ii) the details of the Study set forth in the Study Protocol.
Performance of the Study a. Poskytovatel a hlavní zkoušející poskytnou služby spojené s provedením klinického hodnocení, uvedené v protokolu, který je součástí této smlouvy, a začleněné v této smlouvě (dále jen „služby“). Služby budou poskytovány v souladu s podmínkami této smlouvy, protokolem a všemi platnými zákony, pravidly a předpisy, avšak za předpokladu, že protokol byl schválen společností PPD, zadavatelem, Státním ústavem pro kontrolu léčiv (dále jen „regulační úřad” nebo „RU“), multi-centrickou etickou komisí (dále jen “MEK“) a příslušnou lokální etickou komisí („LEK“). Pokud existuje rozpor mezi podmínkami uvedenými v protokolu a v této smlouvě, pak jsou určující podmínky protokolu pro provádění klinického hodnocení a léčbu subjektů s ním související a podmínky smlouvy jsou určující pro ostatní záležitosti. Kopie souhlasných stanovisek RÚ, MEK a LEK tvoří Přílohu č. 4 této smlouvy. Institution and Principal Investigator shall provide those certain services related to the conduct of the Study and set forth in the Protocol, which Protocol is made a part of this Agreement and incorporated by reference herein (“Services”). The Services shall be provided in accordance with the terms of this Agreement, the Protocol, and all applicable laws, rules and regulations; provided, however that such Protocol has been approved by PPD, Sponsor, the State Institute for Drug Control (“
Performance of the Study. Ichilov Tech shall procure the services of the Fund and/or the Hospital for the performance of the Study. Ichilov Tech shall procure that the technical, clinical and other resources reasonably required for the performance of the Study shall be dedicated to the performance of the Study. The term of the Study shall commence on the Effective Date ending as described in the Study Protocol, or as may be extended with the mutual written agreement of the Parties hereto. The Study shall be performed under the supervision of _____________________________, who shall serve as the Principal Investigator. In the event that the Principal Investigator is unable to continue conducting the Study, Ichilov Tech shall use its best efforts to appoint a successor investigator whose identity shall be jointly determined by the Parties. Ichilov Tech and the Company shall hold status meetings with the Principal Investigator starting on the Effective Date. In such meetings, the Parties shall review and discuss the progress of the Study, analyze the results, and discuss and attempt to resolve any problem in the Study and any feedback collected during the preceding time period.
Performance of the Study. The Study shall commence as soon as practicable after the Effective Date and shall be performed at various sites in the TDN and at various sites outside the TDN if it is deemed necessary by TG, utilizing the TDN’s oversight services, in accordance with (i) the draft summary work plan developed and agreed to by the Parties (the “Work Plan”), as amended, from time to time, upon the mutual agreement of the Parties, and (ii) the details of * Confidential treatment requested. the Study set forth in protocol number 25E01 entitled “A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis”.
