definiens: means all activities related to research, pre - clinical and othernon - clinical testing, test method development and stability testing, toxicology, formulation, processdevelopment, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT . THE COPY FILEDHEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST . OMISSIONS AREDESIGNATED [ * * * ] . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION.***Text Omitted and Filed SeparatelyConfidential Treatment RequestedUnder 17 C.F.R. § § 200.80(B)(4 ) and 240.24b-2manufacturing scale - up, qualification and validation, quality assurance / quality control, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation andsubmission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all otheractivities necessary or reasonably useful or otherwise requested or required by a Regulatory Authorityas a condition or in support of obtaining or maintaining a Regulatory Approval . When used as a verb, means to engage in Development