Compliance with Protocol. MRI Centre agrees to condu and/or super- vise the Services strily in accordance with the Manual and Instruions provi- ded in written form by the Sponsor and Accelsiors which is incorporated into and made a part of this Agreement. 3.3. Dodržiavanie protokolu: MRI cent- rum súhlasí, že bude poskytovať a/alebo dohliadať na Služby presne v súlade s Manuálom alebo Pokynmi poskytnutými v písomnej forme zo strany Zadávateľa/Accelsiors, ktoré sú začlenené do tejto Zmluvy a tvoria jej neoddeliteľnú súčasť.
Compliance with Protocol. Institution shall act in strict accordance with the Protocol and applicable Study Documents, both of which may only be amended and/or revised by written amendment(s) to this Agreement. Institution shall ensure that Personnel shall act in the same manner as Institution. Institution may not deviate from the Protocol without Sponsor's prior written consent except as necessary to protect the safety and welfare of the subjects who participate in the Study (each, a "Subject" and collectively, the "Subjects") and in conformity with the generally accepted standards of the medical community in which Principal Investigator practices. The Site shall immediately notify and/or CRO of any such deviation and follow with prompt written confirmation thereof. 2.2.
Compliance with Protocol. The Investigator is responsible for compliance with the protocol at the investigational site. A representative of the Sponsor will make frequent contact with the Investigator and his/her research staff and will conduct regular monitoring visits at the site to review subject and study drug accountability records for compliance with the protocol. Protocol deviations will be discussed with the Investigator upon identification. The use of the data collected for the subject will be discussed to determine if the data are to be included in the analysis. The Investigator will enter data that may be excluded from analysis as defined by the protocol deviation specifications. Significant protocol deviations will be reported to the IRB/IEC/REB according to the IRB/IEC/REB’s reporting requirements.
Compliance with Protocol. 5.1. The PI must comply with the approved protocol.
Compliance with Protocol. Institution, Principal Investigator and Personnel shall conduct each study in strict accordance with the Protocol and applicable Study Documents , which may be amended and/or revised in writing by Sponsor on a case-by-case basis. Institution and Principal Investigator may not deviate from the Protocol set forth in a Protocol Agreement without Sponsor's prior written consent except as necessary to protect the safety and welfare of the Study Patients and in conformity with the generally accepted standards of the medical community in which Principal Investigator practices. Institution and Principal Investigator shall immediately notify Sponsor of any such deviation and follow with prompt written confirmation thereof. 2.3. Compliance with laws, regulations and guidelines. Institution, Principal Investigator and Personnel shall comply with all applicable federal, state and local laws, regulations and guidelines, including but not limited to the (i) Federal Food Drug and Cosmetics Act, as amended and regulations promulgated thereunder, (ii) regulations of the Centers for Medicare and Medicaid Services ("CMS"), (iii) regulations and guidances governing the protections of human subjects, including but not limited to the Declaration of Helsinki, (iv) regulations and guidances governing the conduct of clinical research, specifically including but not limited to GCP, (v) laws and regulations governing the purchase and sale of securities in a company while in possession of material, non-public information about that company, (vi) laws, rules and regulations regarding the federal anti-kickback statute (42 U.S.C. 1320a-7(b)) and the related safe harbor regulations, and (vii) the Limitation on Certain Physician Referrals, also referred to as the "Xxxxx Law" (42 U.S.C. 1395nn). Additionally, Institution, Principal Investigator and Personnel shall comply with generally accepted professional clinical and research standards of care. 2.4.
Compliance with Protocol. SECTION 3.1 The license rights granted in Section 2.1 above in connection with the use of the OpenFlow Trademark are subject to Licensee’s strict compliance with the requirements of this Section 3.
