Institution and Investigator acknowledge and agree that its, his or her judgment with respect to its, his or her advice to and care of each Subject is not and shall not be affected by the compensation Institution and/or Investigator receive in accordance with the Study.
Institution and Investigator acknowledge that SPONSOR has no obligation to indemnify or be responsible for any loss, claim, cost (including reasonable attorney fees) or demand if and to the extent such losses, claims or demands arise from any injuries or damages resulting from Institution’s, Investigator’s or the Study Personnel’s negligence, breach of this Agreement, failure to adhere to the Protocol, failure to obtain signed informed consent forms, failure to follow Applicable Law, misuse of the Study Drug, unauthorized warranties, or willful misconduct. This indemnification obligation is without prejudice to the precedence of insurance coverage from compulsory clinical trial insurance.
Institution and Investigator hereby acknowledge and agree that each has received sufficient Information regarding their respective participation in the Study. In addition, Investigator further warrants (i) that he/she has distributed all relevant Information to the Study Personnel who have a need to know such Information in order to perform their assigned tasks on the Study, and (ii) that he/she, and all Study Personnel (as applicable), has read and understands such Information.
Institution and Investigator acknowledge and agree that its, his or her judgment with respect to its, his or her advice to and care of each Subject is not and shall not be affected by the compensation Institution and/or Investigator receive in connection with the Study. 15.3 Zdravotnické zařízení a zkoušející berou na vědomí a souhlasí, že odměna, kterou získávají na základě této smlouvy za poskytované služby, žádným způsobem nesmí ovlivnit jejich medicínský úsudek a kvalitu zdravotní péče poskytovanou pacientům.
Institution and Investigator. The INSTITUTION and the INVESTIGATOR undertake that they are under no obligation or restriction which would in any way interfere or be inconsistent with or present a conflict of interest with the obligations undertaken herein. In particular, the INSTITUTION and the INVESTIGATOR undertake that they comply with any applicable anti-corruption law and that this Agreement or the conduct of this Study shall not result into any conflict of interest. The INSTITUTION and the INVESTIGATOR undertake for the term of this Agreement that they shall not conduct any other clinical trial which adversely affects the INSTITUTION’s and/or the INVESTIGATOR’s ability to perform its obligations under this Agreement. The INSTITUTION and the INVESTIGATOR undertake to archive all the Study records for a period of at least twenty-five (25) years after the end of the Study or longer upon lawful instruction of the SPONSOR, and medical records of the Study Participant during at least thirty (30) years after the last Study Participant contact, in full compliance with any Applicable Laws. The INSTITUTION and the INVESTIGATOR may not use any information other than publicly available information regarding the Study in any publicity and advertising without SPONSOR’s prior written consent and ethics committee approval.
Institution and Investigator hereby consent to provide the EC of the Institution and the central EC for multicentre clinical trials with this Agreement in substantiation of the Study conditions, including funding, as according to the Applicable Law.
Institution and Investigator shall (a) keep a detailed and written inventory of all clinical supplies and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions and (b) retain all necessary Subject records and/or documents whether electronic, paper, or in any other form relating to the Study for fifteen (15) years after the end or the premature termination of the Study. Institution and Investigator shall provide to CRO or its Affiliates all study data collected on case report forms as instructed by CRO.
Institution and Investigator acknowledge and agree that its, his or her judgment with respect to its, his or her advice to and care of each Subject is not and shall not be affected by the compensation Institution and/or Investigator receive in accordance with the Study. Institution and Investigator further represent and warrant that neither they nor any of their respective owners, directors, employees, agents, or consultants, nor any payee under this Agreement, will, in order to assist Sponsor or CRO to secure an improper advantage or obtain or retain business, directly or indirectly pay, offer or promise to pay, or give any Items of value to any person or entity for purposes of (i) influencing any act or decision; (ii) inducing such person or entity to do or omit to do any act in violation of their lawful duty; (iii) securing any improper advantage; or (iv) inducing such person or entity to use influence with the government or instrumentality thereof to affect or influence any act or decision of the government or instrumentality. In addition to other rights or remedies under this Agreement or at law, CRO may terminate this Agreement if Institution and/or Investigator breaches any of the representations or warranties contained in this Section or if CRO or Sponsor learns that improper payments are being or have been made to or by Institution or Investigator or any individual or entity acting on its or their behalf.
Institution and Investigator agree that because the Study is part of a multi-center/multi-centre Study, any publication by Institution or Investigator of the Study Results shall not be made before the first multi-center/multi-centre publication.
Institution and Investigator shall be liable under this Agreement for damages resulting from negligence or wilful misconduct in the execution of the Study.
