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. 3.1.2 The Protocol shall be considered final following approval by the designated IEC and when SÚKL issues the respective permission, or where applicable, does not refuse the clinical trial. Protokol bude považován za finální, jakmile bude schválen příslušnou NEK a jakmile SÚKL vydá povolení, nebo, v příslušných případech, pokud SÚKL Klinické hodnocení nezamítne. 3.1.3 Subject to the remainder of this Section 3.1.3 the Protocol may only subsequently be amended with the prior written Agreement of the parties and Sponsor. In the event that the Investigator wishes to amend the Protocol the Investigator shall give at least ten (10) working days notice containing full details and rationale of the planned deviation to CRO, Sponsor and the IEC and/or SÚKL (or as may be otherwise required by IEC and/or SÚKL stipulations or Regulations) The Investigator may only otherwise deviate from the Protocol in the event that the Investigator reasonably considers that such deviation is necessary to deal with a patient emergency and in the event of such deviation the Investigator shall immediately notify CRO, Sponsor and the IEC and/or SÚKL in writing thereof. Dle této zbývající části odstavce 3.1.3 může být Protokol měněn pouze na základě předchozí písemné dohody smluvních stran a Zadavatele. V případě, že si Zkoušející přeje Protokol upravit nebo doplnit, učiní o xxx Zkoušející oznámení společnosti CRO, Zadavateli a NEK a/nebo SÚKL, které bude obsahovat úplné podrobnosti a odůvodnění zamýšleného odchýlení, a to alespoň (10) pracovních dní předem (nebo jak požadují předpisy NEK a/nebo SÚKL nebo Právní předpisy). Zkoušející se jinak může od Protokolu odchýlit pouze tehdy, když po přiměřené úvaze dospěje k závěru, že toto odchýlení je nezbytné za účelem řešení naléhavého stavu pacienta a v případě takového odchýlení bude ...
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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. 3.1.2 The Protocol shall be considered final following approval by the designated IEC and when SÚKL issues the respective permission, or where applicable, does not refuse the clinical trial. Protokol bude považován za finální, jakmile bude schválen příslušnou NEK a jakmile SÚKL vydá povolení, nebo, v příslušných případech, pokud SÚKL Klinické hodnocení nezamítne.
Sample 1
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 3.1.2 The Protocol shall be considered final following approval by the designated IEC. Protokol je xxxxxxxxx xx xxxxxxx xx xxxxxxxxx xxxxxxxxxx(xx) XX. 3.1.3 Subject to the remainder of this Section 3.1.3 the V souladu se zbývajícími ustanoveními tohoto Protocol may only subsequently be amended with článku 3.1.3 může být protokol později the prior written agreement of the parties. In the pozměněn pouze na základě předchozího event that the Investigator wishes to a...
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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.

  • Compliance Procedures The Adviser will, in accordance with Rule 206(4)-7 of the Advisers Act, adopt and implement written policies and procedures reasonably designed to prevent violations of the Advisers Act and will provide the Trust with copies of such written policies and procedures upon request.

  • Compliance Plan (1) This paragraph (h) applies to any portion of the contract that— (i) Is for supplies, other than commercially available off-the-shelf items, acquired outside the United States, or services to be performed outside the United States; and (ii) Has an estimated value that exceeds $500,000. (2) The Contractor shall maintain a compliance plan during the performance of the contract that is appropriate— (i) To the size and complexity of the contract; and (ii) To the nature and scope of the activities to be performed for the Government, including the number of non- United States citizens expected to be employed and the risk that the contract or subcontract will involve services or supplies susceptible to trafficking in persons.

  • 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.

  • Exchange Act Compliance; Regulations T, U and X None of the transactions contemplated herein or in the other Transaction Documents (including, without limitation, the use of proceeds from the sale of the Collateral Portfolio) will violate or result in a violation of Section 7 of the Exchange Act, or any regulations issued pursuant thereto, including, without limitation, Regulations T, U and X of the Board of Governors of the Federal Reserve System, 12 C.F.R., Chapter II. The Borrower does not own or intend to carry or purchase, and no proceeds from the Advances will be used to carry or purchase, any “margin stock” within the meaning of Regulation U or to extend “purpose credit” within the meaning of Regulation U.

  • 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. b. Prepare and distribute appropriate Internal Revenue Service forms for corresponding Fund and shareholder income and capital gains. c. Issue tax withholding reports to the Internal Revenue Service.

  • 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. 5.04 HAZARDOUS MATERIALS: INDEMNIFICATION (a) Developer agrees to the following. (i) Developer shall not receive, store, dispose, or release any Hazardous Materials on or to the Property; transport any Hazardous Materials to or from the Property; or permit the existence of any Hazardous Material contamination on the Property. (ii) Developer shall give written notice to the GLO immediately when Developer acquires knowledge of the presence of any Hazardous Material on the Property; the transport of any Hazardous Materials to or from the Property; or the existence of any Hazardous Material contamination on the Property, with a full description thereof. (iii) Developer will promptly, at Developer’s sole cost and expense, comply with any Governmental Requirements regarding the removal, treatment, or disposal of such Hazardous Materials or Hazardous Material contamination and provide the GLO with satisfactory evidence of such compliance. (iv) Developer shall provide the GLO, within thirty (30) days of demand by the GLO, financial assurance evidencing to the GLO that the necessary funds are available to pay for the cost of removing, treating, and disposing of such Hazardous Materials or Hazardous Material contamination and discharging any assessments that may be established on the Property as a result thereof. (v) Developer shall insure that all leases, licenses, and agreements of any kind (whether written or oral) now or hereafter executed that permit any party to occupy, possess, or use in any way the Property or any part thereof include an express prohibition on the disposal or discharge of any Hazardous Materials at the Property and a provision stating that failure to comply with such prohibition shall expressly constitute a default under any such agreement. (vi) Developer shall not cause or suffer any liens (including any so-called state, federal, or local “Superfund” lien relating to such matters) to be recorded against the Property as a consequence of, or in any way related to, the presence, remediation, or disposal of Hazardous Materials in or about the Property. (b) DEVELOPER SHALL, AT ALL TIMES, RETAIN ANY AND ALL LIABILITIES ARISING FROM THE PRESENCE, HANDLING, TREATMENT, STORAGE, TRANSPORTATION, REMOVAL, OR DISPOSAL OF HAZARDOUS MATERIALS ON THE PROPERTY. REGARDLESS OF WHETHER ANY EVENT OF DEFAULT OCCURS OR CONTINUES, WHETHER THE GLO EXERCISES ANY REMEDIES IN RESPECT TO THE PROPERTY, OR SUCH SITUATION RELATED TO HAZARDOUS MATERIALS WAS CAUSED BY OR WITHIN THE CONTROL OF DEVELOPER OR THE GLO, DEVELOPER SHALL DEFEND, INDEMNIFY, AND HOLD HARMLESS THE GLO AND ITS OFFICERS, AGENTS, AND EMPLOYEES FROM AND AGAINST ANY AND ALL LIABILITIES, SUITS, ACTIONS, CLAIMS, DEMANDS, PENALTIES, DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, CONSEQUENTIAL DAMAGES, INTEREST, PENALTIES, FINES, AND MONETARY SANCTIONS), LOSSES, COSTS, AND EXPENSES (INCLUDING, WITHOUT LIMITATION, REASONABLE ATTORNEYS’ FEES AND COSTS) THAT MAY: (i) NOW OR IN THE FUTURE (WHETHER BEFORE OR AFTER THE CULMINATION OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT) BE INCURRED OR SUFFERED BY THE GLO BY REASON OF, RESULTING FROM, IN CONNECTION WITH, OR ARISING IN ANY MANNER WHATSOEVER FROM THE BREACH OF ANY WARRANTY OR COVENANT IN THIS SECTION OR THE INACCURACY OF ANY REPRESENTATION OF DEVELOPER IN RELATION TO THIS AGREEMENT;

  • 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. 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.

  • Regulation M Compliance The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Company’s placement agent in connection with the placement of the Securities.

  • DBE/HUB Compliance The Engineer’s subcontracting program shall comply with the requirements of Attachment H of the contract (DBE/HUB Requirements).

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