Use and Return of Investigational Product Sample Clauses

Use and Return of Investigational Product and Equipment 1.6. Použitie a vrátenie skúšaného produktu a vybavenia Sponsor or a duly authorized agent of Sponsor, shall supply Institution or Investigator with sufficient amount of Investigational Product as described in the Protocol. Zadávateľ alebo jeho riadne splnomocnený zástupca dodá zdravotníckemu zariadeniu alebo skúšajúcemu dostatočné množstvo skúšaného produktu, v súlade s protokolom. The Site shall use the Investigational Product,any comparator products and ancillary supplies provided in connection with the Study, solely for the purpose of properly completing the Study and shall maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times. IQVIA is obliged to inform the pharmacy of the Institution about the delivery of the Investigational Product min. 3 working days in advance. X xxxxxx Skúšaného produktu je spoločnosť IQVIA povinná informovať lekáreň zdravotníckeho zariadenia min. 3 pracovné dni vopred. Pracovisko skúšania použije skúšaný produkt a všetky referenčné produkty (komparátory), poskytnuté v súvislosti so skúšaním, výhradne na účely riadneho dokončenia skúšania a za každých okolností bude skúšaný produkt skladovať podľa pokynov zadávateľa a podľa platných právnych predpisov, vrátane skladovania v uzamknutých a zabezpečených priestoroch. Upon completion or termination of the Study, the Site shall return or destroy, at Sponsor’s option, the Investigational Product, comparator products, and materials and all Confidential Information (as defined below) at Sponsor’s sole expense. Po dokončení alebo zastavení skúšania pracovisko skúšania podľa rozhodnutia zadávateľa a výhradne na zadávateľove náklady vráti alebo zlikviduje skúšaný produkt, referenčné produkty, materiály a všetky dôverné informácie (definované nižšie). Institution and Investigator shall comply with all laws and regulations governing the disposition or destruction of Investigational Product and any instructions from IQVIA that are not Zdravotnícke zariadenie a skúšajúci dodržia všetky právne predpisy, ktorými xx xxxxx likvidácia skúšaného produktu a všetky pokyny spoločnosti IQVIA, ktoré nie sú v nesúlade s takýmito právnymi inconsistent with such laws and regulations. predpismi. The Site shall return any equipment or materials provided by Sponsor for use in the Study unless Sponsor and Site have a written agreement for Site to acquire the equipment. If there are Site...
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Use and Return of Investigational Product. Zadavatel bez zbytečného odkladu vyrozumí Místo výkonu klinického hodnocení, EK a IQVIA, ohledně jakéhokoli zjištění, jež je způsobilé ovlivnit bezpečenost Subjektů studie či jejich vůli a ochotu pokračovat v účasti ve Studii, mít vliv na provádění Studie, či změnit vydané souhlasné stanovisko EK vztahující se k pokračování ve Studii. 1.6
Sample 1
Use and Return of Investigational Product and Equipment 1.6. Použitie a vrátenie skúšaného produktu a vybavenia Sponsor or a duly authorized agent of Sponsor, shall supply Investigator at Institution’s facilities with sufficient amount of Investigational Product as described in the Protocol. Zadávateľ alebo jeho riadne splnomocnený zástupca dodá skúšajúcemu do priestorov zdravotníckeho zariadenia dostatočné množstvo skúšaného produktu, v súlade s protokolom. Institution will enable Investigator to maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times. Zdravotnícke zariadenie zabezpečí, aby skúšajúci za každých okolností skladoval skúšaný produkt podľa pokynov zadávateľa a podľa platných právnych predpisov, vrátane skladovania v uzamknutých a zabezpečených priestoroch. If applicable, the Institution shall return any equipment or materials provided by Sponsor for use in the Study unless Sponsor and Institution have a written agreement for V relevantných prípadoch zdravotnícke zariadenie vráti všetko vybavenie a všetky materiály poskytnuté zadávateľom na použitie v skúšaní, pokiaľ zadávateľ a zdravotnícke Institution to acquire the equipment. If there are Institution’s facility improvements provided by IQVIA or Sponsor in relation to the Study, then Institution shall enter a separate written agreement with IQVIA or Sponsor with respect to such facility improvements. zariadenie neuzatvoria písomnú zmluvu o nadobudnutí vybavenia zdravotníckym zariadením. Ak zadávateľ alebo spoločnosť IQVIA poskytnú v súvislosti so skúšaním nejaké úpravy priestorov zdravotníckeho zariadenia, uzatvorí zdravotnícke zariadenie so spoločnosťou IQVIA alebo zadávateľom samostatnú zmluvu, týkajúcu sa takýchto úprav priestorov.
Sample 1
Use and Return of Investigational Product and Equipment 1.6. Použitie a vrátenie skúšaného produktu a vybavenia Sponsor or a duly authorized agent of Sponsor, shall supply Investigator at Institution’s facilities with sufficient amount of Investigational Product as described in the Protocol. Zadávateľ alebo jeho riadne splnomocnený zástupca dodá skúšajúcemu do priestorov zdravotníckeho zariadenia dostatočné množstvo skúšaného produktu, v súlade s protokolom. Institution will enable Investigator to maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times and will not administer or dispense it to anyone who is not a Study subject, or provide access to it to anyone except Investigator, Subinvestigators, or Study Staff. Zdravotnícke zariadenie zabezpečí, aby skúšajúci za každých okolností skladoval skúšaný produkt podľa pokynov zadávateľa a podľa platných právnych predpisov, vrátane skladovania v uzamknutých a zabezpečených priestoroch. a nepodá ho ani nevydá nikomu, kto nie je účastníkom skúšania, ani neposkytne prístup k nemu nikomu okrem skúšajúceho, spoluskúšajúcich alebo personálu skúšania If applicable, the Institution shall return any equipment or materials provided by Sponsor for use in the Study unless Sponsor and Institution have a written agreement for Institution to acquire the equipment. If there are Institution’s facility improvements provided by IQVIA or Sponsor in relation to the Study, V relevantných prípadoch zdravotnícke zariadenie vráti všetko vybavenie a všetky materiály poskytnuté zadávateľom na použitie v skúšaní, pokiaľ zadávateľ a zdravotnícke zariadenie neuzatvoria písomnú zmluvu o nadobudnutí vybavenia zdravotníckym zariadením. Ak zadávateľ alebo spoločnosť Slovakia PI: Xxxxxxxx Xxxxx, MD, PhD, FEBOClinical Trial Agreement template-INST_ based on IQVIA Global template – 1 May 2019 XXXXXXX Xxxxxx 0 z 31
Sample 1

Related to Use and Return of Investigational Product

  • Facilitation of Investigation In case of any allegation of violation of any provisions of this Pact or payment of commission, the BUYER or its agencies shall be entitled to examine all the documents including the Books of Accounts of the BIDDER and the BIDDER shall provide necessary information and documents in English and shall extend all possible help for the purpose of such examination.

  • Regulatory Matters The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.

  • E1 Authority Data E1.1 For the purposes of clauses E1 and 2, the terms “Data Controller”, “Data Processor”, “Data Subject”, “

  • REGULATORY FILINGS AND CAISO TARIFF COMPLIANCE 3.1 Filing

  • Return of Products No Products or part shall be returned to Seller without an approved Return Goods Authorization (“RMA”) from Seller. Custom and special order Products are non-returnable. Returns are subject to a restocking fee.

  • Development cooperation 1. The Parties recognise that development cooperation is a crucial element of their Partnership and an essential factor in the realisation of the objectives of this Agreement as laid down in Article 1. This cooperation can take financial and non-financial forms.

  • 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.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum.

  • Examination of Implementation 1. Without prejudice to the procedures set out in Article 188 (Compensation), once the period of time set out in paragraph 3 of Article 186 (Implementation of the Report) has expired, and there is disagreement between the disputing Parties as to the existence or consistency of the measures taken to comply with the Panel report, such dispute shall be referred to the original Panel wherever possible. If not possible, the procedure pursuant to Article 179 (Panel Selection) shall be followed to appoint a new Panel, in which event the periods set out thereof shall be reduced by half (22). 2. This Panel shall issue its report on the matter within 60 days after the date of the referral of the matter to it. When the Panel considers that it cannot provide its report within this timeframe, it shall inform the Parties in writing of the reasons for the delay together with an estimate of the period within which it will submit its report. Any delay shall not exceed a further period of 30 days unless the Parties otherwise agree.

  • TECHNOLOGY/KNOWLEDGE TRANSFER ACTIVITIES The goal of this task is to develop a plan to make the knowledge gained, experimental results, and lessons learned available to the public and key decision makers. The Recipient shall: • Prepare an Initial Fact Sheet at start of the project that describes the project. Use the format provided by the CAM. • Prepare a Final Project Fact Sheet at the project’s conclusion that discusses results. Use the format provided by the CAM. • Prepare a Technology/Knowledge Transfer Plan that includes: o An explanation of how the knowledge gained from the project will be made available to the public, including the targeted market sector and potential outreach to end users, utilities, regulatory agencies, and others.

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