Compliance Prohlášení o shodě Sample Clauses

Compliance Prohlášení o shodě. 3.1.1 The Investigator shall conduct the Study, according to the Protocol, the Regulations, this Agreement, written instructions of Sponsor and/or CRO and the terms of the approval for the Study from the IEC and conditions stated in permission of SÚKL or, where permission is not required, conditions determined in the respective announcement. Zkoušející bude Klinické hodnocení provádět v souladu s Protokolem, Právními předpisy, touto Smlouvou, písemnými pokyny Zadavatele a/nebo společnosti CRO a podmínkami schválení provedení Klinického hodnocení uděleného NEK a podmínkami povolení od SÚKL, nebo, pokud povolení není vyžadováno, podmínkami příslušného vyjádření.
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Compliance Prohlášení o shodě. 3.1.1 The Investigator shall conduct the Study, according to the Protocol, the Regulations, this Agreement, written instructions of ICON and the terms of the approval for the Study from Zkoušející provede studii v souladu s protokolem, zákonnými předpisy, touto smlouvou, písemnými pokyny společnosti ICON a podmínkami schválení studie ze the IRB/IEC. strany IRB/IEC.
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Compliance Prohlášení o shodě. 3.1.1 The Institution shall conduct the Study in compliance with: a) the State Institute for Drug Control Approval issued on 10 May 2016 with the Ref. No.: sukls 30349/2016 (Appendix 6) b) the Opinion of the Ethics Committee for Multicenter Trials (applicable only to multicenter trials) and in the Opinion of the Institutional Ethics Committee issued on 2 March 2016 with the Ref. No.: 2.3.2016/23 Zdravotnické zařízení provede Klinické hodnocení v souladu: a) povolením vydaném k provedení klinického hodnocení Státním ústavem pro kontrolu léčiv vydaného dne 10. května 2016 pod č.j. sukls 30349/2016 (Příloha č. 6), b) se stanoviskem etické komise pro multicentrická hodnocení (jen v případě multicentrických hodnocení) a stanovisku etické komise zdravotnického zařízení (Appendix 7), c) the Protocol; and any changes to the Protocol that are permitted with the Institution’s consent and in compliance with Section 56 of Act No. 378/2007 Coll., on Pharmaceuticals as amended. d) Regulations e) written guidelines of ICON/Sponsor. vydaného dne 2. března 2016 pod č.j. 2.3.2016/23 (Příloha č. 7), c) s Protokolem; a změny Protokolu, které lze provést se souhlasem zdravotnického zařízení a v souladu s § 56 zákona č. 378/2007 Sb., o léčivech, ve znění pozdějších předpisů; d) se zákonnými předpisy e) písemnými pokyny společnosti ICON/Zadavatele. The application for approval to the State Institute Žádost o povolení Státního úřadu pro kontrolu for Drug Control and the Favourable Opinion of léčiv a souhlas etické komise/etických komisí the Ethics Committee/s will be submitted by the bude podána zadavatelem/ICON. Sponsor/ICON. The Sponsor/ICON will liaise with Zadavatel/ICON bude jednat s etickou the Ethics Committee/s. komisí/etickými komisemi. Strany berou na The parties acknowledge that ICON or Sponsor vědomí, že ICON nebo zadavatel rovněž also notify the State Institute for Drug Control of oznamuje Státnímu úřadu pro kontrolu léčiv significant amendments to the Protocol in významné změny protokolu podle § 56 odst. 1
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Compliance Prohlášení o shodě. 3.1.1 The Institution shall ensure that the Study is conducted according to the Protocol, the Regulations, this Agreement, written instructions of Sponsor and/or CRO and the terms of the approval for the Study from the IEC and conditions stated in permission of SÚKL or, where permission is not required, conditions determined in the respective announcement. Zdravotnické zařízení zajistí, xx Xxxxxxxx hodnocení bude prováděno v souladu s Protokolem, Právními předpisy, touto Smlouvou, písemnými pokyny Zadavatele a/nebo společnosti CRO a podmínkami schválení provedení Klinického hodnocení uděleného NEK a podmínkami povolení od SÚKL, nebo, pokud povolení není vyžadováno, podmínkami příslušného vyjádření.
Sample 1

Related to Compliance Prohlášení o shodě

  • Compliance Program The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.

  • Labor Compliance Program The City has its own Labor Compliance Program authorized in August 2011 by the DIR. The City will withhold contract payments when payroll records are delinquent or deemed inadequate by the City or other governmental entity, or it has been established after an investigation by the City or other governmental entity that underpayment(s) have occurred. For questions or assistance, please contact the City of San Diego’s Equal Opportunity Contracting Department at 000-000-0000.

  • Compliance Plan (1) This paragraph (h) applies to any portion of the contract that—

  • ANTI-BRIBERY COMPLIANCE The Parties hereby acknowledge the importance of combating and preventing bribery and to that end both Parties agree to comply fully with all applicable laws, regulations and sanctions relating to anti-bribery and anti-corruption.

  • PCI-DSS Compliance Merchant shall be in full compliance with rules, regulations, guidelines and procedures adopted by any Card Association or Payment Network relating to the privacy and security of Cardholder and Card transaction data, including without limitation the most up-to-date version of the Payment Card Industry Data Security Standard (PCI-DSS), as amended from time to time by the Payment Card Industry Security Standards Council. Detailed information pertaining to aforementioned requirements may be found at xxxxx://xxx.xxxxxxxxxxxxxxxxxxxx.xxx. Additional information regarding security requirements may be found on the Card Association’s respective web sites.

  • Corporate Compliance Program Maintain, and will cause each other Loan Party to maintain on its behalf, a corporate compliance program reasonably acceptable to Agent. Until the Obligations have been Paid in Full, Borrower will modify such corporate compliance program from time to time (and cause the other Loan Parties and Subsidiaries to modify their respective corporate compliance programs) as may be reasonable to attempt to ensure continuing compliance in all material respects with all material applicable laws, ordinances, rules, regulations and requirements (including, in all applicable material respects, any material Health Care Laws). Borrower will permit Agent and/or any of its outside consultants to review such corporate compliance programs from time to time upon reasonable notice and during normal business hours of Borrower.

  • Compliance Reporting a. Provide reports to the Securities and Exchange Commission, the National Association of Securities Dealers and the States in which the Fund is registered.

  • Compliance Review During the Term, Developer agrees to permit the GLO, HUD, and/or a designated representative of the GLO or HUD to access the Property for the purpose of performing Compliance-Monitoring Procedures. In accordance with GLO Compliance-Monitoring Procedures, the GLO or HUD will periodically monitor and audit Developer’s compliance with the requirements of this Agreement, the CDBG-DR Regulations, the CDBG Multifamily Rental Housing Guidelines, and any and all other Governmental Requirements during the Term. In conducting any compliance reviews, the GLO or HUD will rely primarily on information obtained from Developer’s records and reports, on-site monitoring, and audit reports. The GLO or HUD may also consider other relevant information gained from other sources, including litigation and citizen complaints. Attachment G GLO Contract No. 19-097-041-B662 5.04 HAZARDOUS MATERIALS: INDEMNIFICATION

  • Policy Compliance Violations The Requester and Approved Users acknowledge that the NIH may terminate the DAR, including this Agreement and immediately revoke or suspend access to all controlled-access datasets subject to the NIH GDS Policy at any time if the Requester is found to be no longer in agreement with the principles outlined in the NIH GDS Policy, the terms described in this Agreement, or the Genomic Data User Code of Conduct. The Requester and PI agree to notify the NIH of any violations of the NIH GDS Policy, this Agreement, or the Genomic Data User Code of Conduct data within 24 hours of when the incident is identified. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. The Requester and PI agree to notify the appropriate DAC(s) of any unauthorized data sharing, breaches of data security, or inadvertent data releases that may compromise data confidentiality within 24 hours of when the incident is identified. As permitted by law, notifications should include any known information regarding the incident and a general description of the activities or process in place to define and remediate the situation fully. Within 3 business days of the DAC notification(s), the Requester agrees to submit to the DAC(s) a detailed written report including the date and nature of the event, actions taken or to be taken to remediate the issue(s), and plans or processes developed to prevent further problems, including specific information on timelines anticipated for action. The Requester agrees to provide documentation verifying that the remediation plans have been implemented. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. All notifications and written reports of data management incidents should be sent to the DAC(s) indicated in the Addendum to this Agreement. NIH, or another entity designated by NIH may, as permitted by law, also investigate any data security incident or policy violation. Approved Users and their associates agree to support such investigations and provide information, within the limits of applicable local, state, tribal, and federal laws and regulations. In addition, Requester and Approved Users agree to work with the NIH to assure that plans and procedures that are developed to address identified problems are mutually acceptable and consistent with applicable law.

  • Compliance Monitoring Grantee must be subject to compliance monitoring during the period of performance in which funds are Expended and up to three years following the closeout of all funds. In order to assure that the program can be adequately monitored, the following is required of Grantee:

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