Common use of Ethics Committee/State Institute for Drug Control Clause in Contracts

Ethics Committee/State Institute for Drug Control. Before the Study is initiated, CRO will obtain or will procure a third party to obtain approval of the Study and informed consent document by the State Institute for Drug Control (“SUKL”) and the Ethics Committee. CRO will use reasonable endeavours to ensure that the Study is subject to continuing oversight by the Ethics Committee/SUKL throughout its conduct. In case of multi-center studies, CRO will submit request for opinion to only one Ethics Committee for multi-center study and at the same time, CRO will submit request for opinion to Ethics Committee of institutions where the respective clinical study should be performed. Should no Ethics Committee be established for some of the places of planned performance of the clinical study, the Ethics Committee for multi- center study would provide its opinion for such a place.

Ethics Committee/State Institute for Drug Control. Before the Study is initiated, CRO will obtain or will procure a third party to obtain approval of the Study and informed consent document by the State Institute for Drug Control (“SUKL”) and the Ethics Committee. CRO will use reasonable endeavours to ensure that the Study is subject to continuing oversight by the Ethics Committee/SUKL throughout its conduct. In case of multi-center studies, CRO will submit request for opinion to only one Ethics Committee for multi-center study and at the same time, CRO will submit request for opinion to Ethics Committee of institutions where the respective clinical study should be performed. Should no Ethics Committee be established for some of the places of planned performance of the clinical study, the Ethics Committee for multi- multi-center study would provide its opinion for such a place.

Ethics Committee/State Institute for Drug Control. Before the Study is initiated, CRO Pfizer will obtain or will procure a third party to obtain approval of the Study and informed consent document by the State Institute for Drug Control (“SUKL”) and the Ethics Committee. CRO Pfizer will use reasonable endeavours to ensure that the Study is subject to continuing oversight by the Ethics Committee/SUKL throughout its conduct. In case of multi-center studies, CRO Pfizer will submit request for opinion to only one Ethics Committee for multi-center study and at the same time, CRO Pfizer will submit request for opinion to Ethics Committee of institutions where the respective clinical study should be performed. Should no Ethics Committee be established for some of the places of planned performance of the clinical study, the Ethics Committee for multi- multi-center study would provide its opinion for such a place.