Conduct of the Study 1. PROVEDENÍ STUDIE Sample Clauses

Conduct of the Study 1. PROVEDENÍ STUDIE. 1.1. Compliance with Laws, Regulations, and Good Clinical Practices Institution agrees that Institution and Study Staff shall perform the Study at Institution in strict accordance with this Agreement, the Protocol (enclosed hereto as Attachment B), any and all applicable laws regulations and guidelines, including in particular, but without limitation, GCPs, Principles of the Declaration of Helsinki and the conditions specified by the Ethics Committee for Multicentrics Trials and Local Ethics Committees/Regulatory Agency ,Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) and Decree No. 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended, Act No. 372/2011 Coll., on Medical Services and terms and conditions of performance of such services („Act on Medical Services“) or any subsequent amendments or laws substantially replacing any of the foregoing.(together “Applicable Laws”). The parties further confirm that they hold all necessary licences, permits and consents necessary to conduct this Study. 1.1 Soulad s Právními předpisy, nařízeními a Správnou klinickou praxí Zdravotnické zařízení souhlasí s tím, že Zdravotnické zařízení a Studijní personál provedou ve Zdravotnickém zařízení Studii v přísném souladu s touto Smlouvou, Protokolem (který je k této Smlouvě připojen jako Příloha B), veškerými příslušnými právními předpisy a nařízeními, zejména včetně GCP, zásad Helsinské deklarace a podmínek stanovených Etickou komisí pro multicentrická klinická hodnocení, místními etickými komisemi /Regulatorním orgánem, zák. č. 378/2007 Sb., o léčivech a změnách některých souvisejících zákonů (“Zákon o léčivech”) a Vyhlášky č. 226/2008 Sb., o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, v platném znění, zák. č. 372/2011 Sb., o Zdravotních službách a podmínkách jejich poskytování („Zákon o zdravotních službách“) nebo jakýchkoli následných pozměňujících či podstatně nahrazujících právních předpisů ve vztahu ke shora uvedeným právním normám, (společně “Příslušné právní předpisy”). Smluvní strany dále potvrzují, že jsou držiteli všech potřebných oprávnění, povolení a souhlasů nutných k provádění Studie. 1.2.
AutoNDA by SimpleDocs
Conduct of the Study 1. PROVEDENÍ STUDIE. 1.1. Compliance with Laws, Regulations, and Good Clinical Practices

Related to Conduct of the Study 1. PROVEDENÍ STUDIE

  • 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • 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.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • 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.

  • Research Project 3.1 These Materials and Data will be used by Recipient's PI solely in connection with the Research Project, as named and described in the attached research application (insert Research Project name below):

  • Development of the Project 4.1 TSP's obligations in development of the Project: Subject to the terms and conditions of this Agreement, the TSP at its own cost and expense shall observe, comply with, perform, undertake and be responsible:

  • Development of the Property Except as modified by this Agreement, the Development and the Property will be developed in accordance with all applicable local, state, and federal regulations, including but not limited to the City’s ordinances and the zoning regulations applicable to the Property, and such amendments to City ordinances and regulations that that may be applied to the Development and the Property under Chapter 245, Texas Local Government Code, and good engineering practices (the “Applicable Regulations”). If there is a conflict between the Applicable Regulations and the Development Standards, the Development Standards shall control.

  • Trials The Ship shall run the following test and trials:

  • Special Studies Providing planning services, site evaluations, environmental studies, or comparative studies of prospective sites, preparing special surveys, studies, and submissions required under Applicable Law.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!