Audit by Hexal and Records Sample Clauses

Audit by Hexal and Records. The Institution shall permit Hexal and its agents, during normal business hours and at mutually agreeable times, to inspect and make abstracts of records and reports collected and generated by the Institution and the Principal Investigator in the course of conducting the Trial and to inspect the facilities at which the Trial is conducted to verify compliance with this Agreement, the Protocol and Applicable Laws and Regulations and the accuracy of information provided in connection with the Trial. The Institution shall ensure that the Principal Investigator and other relevant personnel is available for Hexal and its agents during an audit in order to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Hexal or its agents, the Institution and the Principal Investigator shall immediately correct any errors or omissions in such records and reports. The Institution shall preserve all records relating to the Trial and the Subjects participating therein as required by the Protocol and otherwise in accordance with the Applicable Laws and Regulations, and shall, in writing, offer such records to Hexal before destroying or disposing thereof. (b) Audit prováděný Hexalem a záznamy. Zdravotnické zařízení umožní Hexalu a jeho zástupcům v obvyklou pracovní dobu a ve vzájemně dohodnutém čase zkontrolovat a pořídit výpisy ze záznamů a zpráv shromážděných a vytvořených zdravotnickým zařízením a hlavním zkoušejícím v průběhu provádění klinického hodnocení, zkontrolovat zařízení, ve kterém se hodnocení provádí, ověřit dodržování této smlouvy, protokolu a platných právních předpisů a ověřit správnost údajů poskytnutých v souvislosti s hodnocením. Zdravotnické zařízení zajistí, aby hlavní zkoušející a další příslušní pracovníci byli k dispozici Hexalu a jeho zástupcům v průběhu auditu, aby bylo možno konzultovat tyto záznamy a zprávy a vyřešit jakékoli otázky týkající se těchto záznamů a zpráv. Na žádost Hexalu nebo jeho zástupců zdravotnické zařízení a hlavní zkoušející neprodleně opraví případné chyby nebo doplní chybějící údaje v záznamech a zprávách. Zdravotnické zařízení uchová všechny záznamy týkající se klinického hodnocení a subjektů v souladu s protokolem a s platnými právními předpisy a písemně nabídne tyto záznamy Hexalu před jejich likvidací.
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Related to Audit by Hexal and Records

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  • Force Majeure If by reason of Force Majeure, either party hereto shall be rendered unable wholly or in part to carry out its obligations under this Agreement then such party shall give notice and full particulars of Force Majeure in writing to the other party within a reasonable time after occurrence of the event or cause relied upon, and the obligation of the party giving such notice, so far as it is affected by such Force Majeure, shall be suspended during the continuance of the inability then claimed, except as hereinafter provided, but for no longer period, and such party shall endeavor to remove or overcome such inability with all reasonable dispatch. Choice of Law The Agreement between the Vendor and TIPS/ESC Region 8 and any addenda or other additions resulting from this procurement process, however described, shall be governed by, construed and enforced in accordance with the laws of the State of Texas, regardless of any conflict of laws principles. Venue, Jurisdiction and Service of Process Any Proceeding arising out of or relating to this procurement process or any contract issued by TIPS resulting from or any contemplated transaction shall be brought in a court of competent jurisdiction in Camp County, Texas and each of the parties irrevocably submits to the exclusive jurisdiction of said court in any such proceeding, waives any objection it may now or hereafter have to venue or to convenience of forum, agrees that all claims in respect of the Proceeding shall be heard and determined only in any such court, and agrees not to bring any proceeding arising out of or relating to this procurement process or any contract resulting from or any contemplated transaction in any other court. The parties agree that either or both of them may file a copy of this paragraph with any court as written evidence of the knowing, voluntary and freely bargained for agreement between the parties irrevocably to waive any objections to venue or to convenience of forum. Process in any Proceeding referred to in the first sentence of this Section may be served on any party anywhere in the world. Venue for any dispute resolution process, other than litigation, between TIPS and the Vendor shall be located in Camp or Xxxxx County, Texas.

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