Donesta_ _Czech Republic_ Institution Agreement _Final version 1_31May2016July 4th, 2016
FiledJuly 4th, 2016The Study will be performed on the basis of approval of the State Institute for Drug Control issued on 29 April 2016 under ref. No. Sukls27137/2016 , approval of the Multicentric Ethics Committee Fakultni Nemocnice Brno issued on 13 April 2016, under ref. No. .10/16MEK and approval of the Ethics Committee of the Institution issued on 8 March 2016, under ref. No. EK 8.3.2016/592 , which are attached hereto as Exhibits C, D and E. 2. APPLICABLE LAWInstitution shall ensure the Study is conducted in accordance with the Protocol, this Agreement,written instructions from Sponsor or Chiltern (“Instructions”);relevant professional standards of medical practice,all applicable international, federal, state and local laws, guidelines, rules and regulations, applicable privacy laws, rules and regulations and ICH-GCP Guidelines (CPMP/ICH/135/95) . 3. OBLIGATIONS(a) Anti-Bribery & Anti-CorruptionInstitution shall not directly or indirectly pay or promise to pay, or authorize the payment of any money