definiens: or means the international ethical and scientific quality guidelines prepared under the auspicesof the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for thedesign, conduct, performance, monitoring, recording, auditing, analysis, and reporting of clinical trials which are designed to provideassurance that the data and reported results from such clinical trials are 7THE SYMBOL DENOTES PLACES WHERE CERTAIN IDENTIFIEDINFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH ( i)NOT MATERIAL, AND ( ii ) WOULD LIKELY CAUSE COMPETITIVE HARM TO THECOMPANY IF PUBLICLY DISCLOSED credible and accurate, and that trial subject ’s rights, integritiy and confidentiality are protected . Such guidelines include the U.S. Code ofFederal Regulations ( CFR ) Title 21, ICH GCP Guidelines E6(R1 ), current step 4 version, dated 10 June 1996, as amended from time to time, national legislation implementing European Community Directive 2001/20 / EC of 4 April 2001 on the approximation of the laws, regulationsand administrative provisions of the Member States of the European Union relating to the implementation of good clinical practice in theconduct of clinical trials on medicinal products for human use, European Community Directive 2005/28 / EC of 8 April 2005 laying downprinciples and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use