No Debarred or Disqualified Person. The Institution represents and warrants that the Institution has never been and is not currently, and it shall not employ, contract with, or retain any person directly or indirectly to perform the Study under this Agreement (including Principal Investigator) if such person (a) has ever been debarred, disqualified or otherwise deemed ineligible by a government agency or a competent authority to conduct clinical research or receive investigational drugs or devices; or (b) is under investigation, or involved in disqualification or debarment proceedings conducted, by any government agency in relation to clinical research; or (c) has ever been charged with crimes resulting in the revoking of a right to conduct clinical research. If, during the term of this Agreement and for a period of three (3) years after the expiration or termination thereof, the Institution or any person employed or retained by it to perform the Study (i) comes under investigation or is subject to disqualification or debarment proceedings by a government agency in relation to clinical research; (ii) is deemed ineligible to conduct research or receive investigational drugs or devices, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned actions, the Institution shall immediately notify Sponsor/CRO of the same in writing. Upon the occurrence of such event, whether or not such notice is given to Sponsor, Sponsor may immediately terminate this Agreement. 10.3 Žádná osoba se zákazem činnosti nebo odebráním kvalifikace. Místo klinického hodnocení prohlašuje a zaručuje, že ono samo nikdy nebylo ani v současné době není takovou osobou a že nezaměstná žádnou osobu, neuzavře smlouvu s žádnou osobou ani si nenajme žádnou osobu k přímému nebo nepřímému provádění Klinického hodnocení podle této Smlouvy (včetně Hlavního zkoušejícího), která (a) má zakázanou činnost, byla jí odebrána kvalifikace nebo ji státní úřad nebo kompetentní orgán považuje za jinak nevhodnou k realizaci klinického výzkumu nebo k převzetí hodnocených léčiv nebo prostředků; nebo (b) je vyšetřována nebo je součástí řízení o odebrání kvalifikace nebo zákazu činnosti vedeného jakýmkoli státním úřadem ve vztahu ke klinickému výzkumu; nebo (c) byla obviněna z trestných činů a v důsledku toho jí bylo odebráno právo provádět klinický výzkum. Jestliže v průběhu doby trvání této Smlouvy a po dobu tří (3) let po uplynutí nebo ukončení této Smlouvy Místo klinického hodnocení nebo jakákoli osoba jím zaměstnan...
No Debarred or Disqualified Person. ABX-CRO represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform the activities described in the Scope of Services under this Agreement if such a person: (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. ß 335a; or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 CFR ß 312.70 or its successor provisions. In addition, GBG represents and warrants that it has not engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. If, during the term of this Agreement, Vendor or any person employed or retained by it to perform the activities described in the Scope of Services: (i) comes under investigation by the FDA for a debarment action or disqualification; (ii) is debarred or disqualified; or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, ABX-CRO shall immediately notify SPONSOR of same and address the issue as mutually agreed upon by the Parties. Agreement between Anavex Life Sciences Corp. and ABX-CRO advanced pharmaceutical services – Forschungsgesellschaft m.b.H. August 10th 2010
