Conduct of the Study Článek 1 Sample Clauses

Conduct of the Study Článek 1. Provádění Studie Institution agrees that the Principal Investigator and Study Personnel (defined below) are conducting the Study at Institution in accordance with the protocol, “A Phase 2 Study of INCMGA00012 in Participants with Metastatic Xxxxxx Cell Carcinoma” and any subsequent amendments thereto (hereinafter referred to as “Protocol” or “Study”). A copy of the Protocol will be provided to the Principal Investigator. The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by the Institution and Principal Investigator. It is understood and agreed that performance under this Agreement is expressly conditioned upon the approval of the Study the Regulatory Authority and Ethics Committee for Multicentrics Trials (“ECMT”) and Local Ethics Committees (“LEC”), jointly Ethics Committees (“EC”). The Protocol will be considered final after it is signed by the Sponsor and Principal Investigator and approved by the EC. Thereafter, the Protocol may be amended only by prior written consent of Sponsor and subsequent approval by the Regulatory Authority and EC. A copy of the Protocol and any amendments will be maintained in the Principal Investigator’s Study files. In the event of a conflict between the terms of the Protocol and the terms of this Agreement, the terms of the Protocol shall prevail regarding all clinical matters, and the terms of this Agreement shall prevail regarding all other matters. Zdravotnické zařízení souhlasí s xxx, že Hlavní zkoušející a Pracovníci studie (definovaní níže) provádějí Studii ve Zdravotnickém zařízení v souladu s protokolem pod názvem „Klinické hodnocení fáze 2 přípravku INCMGA00012 u pacientů s metastatickým karcinomem z Xxxxxxxxxxx buněk“ a jakýmikoli jeho pozdějšími dodatky (xxxx xxx „Protokol“ nebo „Studie“). Stejnopis Protokolu bude předán Hlavnímu zkoušejícímu. Protokol uvádí do všech podrobností klinické výzkumné činnosti a povinnosti, které na sebe Zdravotnické zařízení a Hlavní zkoušející berou a které budou s vynaložením veškerého úsilí plnit a dodržovat. Strany berou na vědomí a souhlasí s xxx, že plnění této Smlouvy je výslovně podmíněno schválením Studie příslušným Kontrolním úřadem a rovněž Etickou komisí pro multicentrická klinické hodnocení (xxxx xxx „MEK“) a místní etickou komisí (xxxx xxx „LEK“), společně označovanými pojmem Etické komise („EK“). Protokol se bude pokládat za finální po podepsání Zadavatelem a Hlavním zkoušející...
AutoNDA by SimpleDocs
Conduct of the Study Článek 1. Provádění Studie Principal Investigator is responsible for the conduct the Study at Provider in accordance with the protocol, “A Phase 2, Open-Label, Two-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)” and any subsequent amendments thereto (hereinafter referred to as “Protocol” or “Study). The scope and nature of the Study to be performed will be in accordance with the Protocol. A copy of the Protocol will be provided to the Provider and the Principal Investigator under separate cover. The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by the Site. It is understood and agreed that performance under this Agreement is expressly conditioned upon the approval of the Study the Regulatory Authority and Ethics Committee for Multicentrics Trials (“ECMT”) and Local Ethics Committees (“LEC), jointly Ethics Committees (“EC”). The Protocol will be considered final after it is signed by the Sponsor and Principal Investigator and approved by the EC. Thereafter, the Protocol may be amended only by prior written consent of Sponsor and subsequent approval by the Regulatory Authority and EC. A copy of the Protocol and any amendments will be maintained in the Provider’s Study files. In the event of a conflict between the terms of the Protocol and the terms of this Agreement, the terms of the Protocol shall prevail regarding all clinical matters, and the terms of this Agreement shall prevail regarding all other matters. Sponsor herby confirms that no other agreement for this Study will be concluded with the Principal Investigator or any other employee of Provider in connection with this Study. Hlavní zkoušející zodpovídá za provádení Studie u Poskytovatelev souladu s protokolem s názvem „Otevřené, multicentrické, klinické hodnocení fáze 2 s dvema kohortami posuzující přípravek INCB050465, inhibitor PI3Kδ, u pacientů s relabujícím nebo refrakterním lymfomem z plášťových bunek dříve léčených inhibitorem BTK nebo bez nej (CITADEL-205)“ a jakýmikoli jeho pozdejšími dodatky (dále jen „Protokol“ nebo „Studie“). Rozsah a charakter provádené Studie bude odpovídat tomuto Protokolu. Stejnopis Protokolu bude předán Poskytovateli a Hlavnímu zkoušejícímu jako samostatný dokument. Protokol uvádí do všech podrobností klinické výzkumné činnosti a povinnosti, které na sebe Místo...
Conduct of the Study Článek 1. Průběh Studie

Related to Conduct of the Study Článek 1

  • Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.

  • Conduct of the Parties The parties will not engage in behaviour that is, or may reasonably be considered to be intimidating, bullying, or harassing or commit any act or behaviour which is offensive or abusive in connection with this Agreement.

  • Conduct of the Project C.1. The Proposer agrees to do the work set out in the Proposal in accordance with good standards relevant to such undertakings, and shall expend funds received hereunder only in accordance with such Proposal and the requirements of this Agreement.

  • Conduct of the Hearing The arbitrator shall hold the hearing in Monmouth, Oregon, unless otherwise agreed by the parties. The hearing shall commence within fifteen (15) days of the arbitrator's acceptance of the case, unless both parties agree to an extension of time. If the arbitrator or either party requests that post-hearing briefs be submitted, the arbitrator shall establish a date for the submission of such briefs and the hearing will be deemed to have been closed by such date.

  • Procurement of the Site 10.3.1 Pursuant to the notice specified in Clause 4.1.2, the Authority Representative and the Concessionaire shall, on a mutually agreed date and time, inspect the Site and prepare a memorandum containing an inventory of the Site including the vacant and unencumbered land, buildings, structures, road works, trees and any other immovable property on or attached to the Site. Such memorandum shall have appended thereto an appendix (the “Appendix”) specifying in reasonable detail those parts of the Site to which vacant access and Right of Way has not been granted to the Concessionaire. Signing of the memorandum, in two counterparts (each of which shall constitute an original), by the authorised representatives of the Parties shall, subject to the provisions of Clause 10.2.2, be deemed to constitute a valid licence and Right of Way to the Concessionaire for free and unrestricted use and development of the vacant and unencumbered Site during the Concession Period under and in accordance with the provisions of this Agreement and for no other purpose whatsoever. For the avoidance of doubt, it is agreed that valid licence and Right of Way with respect to the parts of the Site as set forth in the Appendix shall be deemed to have been granted to the Concessionaire upon vacant access thereto being provided by the Authority to the Concessionaire.

Time is Money Join Law Insider Premium to draft better contracts faster.