Common use of Data Safety Monitoring Board Clause in Contracts

Data Safety Monitoring Board. A Data Safety Monitoring Board (DSMB) will be formed according to Omnicare CR’s operating procedures and will be solely responsible for evaluating the interim results of the study. One (1) organizational meeting and one (1) interim analysis evaluation meeting are planned. Omnicare CR and Sponsor will jointly develop guidelines for membership of the DSMB, and for conduct of DSMB meeting to be documented in the DSMB Charter. The DSMB members will be recruited by Omnicare/Sponsor. Members of the DSMB will neither have previous involvement with Sponsor’s studies in this area, nor be currently involved in clinical trials of competing therapies. The DSMB will have a written charter that will be produced by a Project Director which will define the responsibilities and will maintain records of all meetings. The written charter will also include a statistical appendix that will document the requirements and guidelines for analyzing and interpreting the interim safety results. Omnicare CR’s biometrics team will prepare mock data displays specific to the DSMB charter. A senior statistician, otherwise unrelated to the study, will be responsible for the development of the data displays defined by the DSMB to ensure interim data accuracy and summaries are produced. These data displays will be programmed and validated by biometrics staff. The validation will be performed through a combination of individual patient data review and independent programming. When the blind is ready to be broken, the DSMB statistician will perform the final run of the DSMB data displays and prepare for the DSMB. For each DSMB meeting, the database will be extracted and the data listings and summary tables will be rerun. If the DSMB requests data clarification or further information, Omnicare CR will re-extract the data and rerun the listings and tables on the new data. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Data Safety Monitoring Board. A Data Safety Monitoring Board (DSMB) will be formed according to Omnicare CR’s operating procedures and will be solely responsible for evaluating the interim results of the study. One (1) organizational meeting and one (1) interim analysis evaluation meeting are planned. Omnicare CR and Sponsor will jointly develop guidelines for membership of the DSMB, and for conduct of DSMB meeting to be documented in the DSMB Charter. The DSMB members will be recruited by Omnicare/Sponsor. Members of the DSMB will neither have previous involvement with Sponsor’s studies in this area, nor be currently involved in clinical trials of competing therapies. The DSMB will have a written charter that will be produced by a Project Director which will define the responsibilities and will maintain records of all meetings. The written charter will also include a statistical appendix that will document the requirements and guidelines for analyzing and interpreting the interim safety results. Omnicare CR’s biometrics team will prepare mock data displays specific to the DSMB charter. A senior statistician, otherwise unrelated to the study, will be responsible for the development of the data displays defined by the DSMB to ensure interim data accuracy and summaries are produced. These data displays will be programmed and validated by biometrics staff. The validation will be performed through a combination of individual patient data review and independent programming. When the blind is ready to be broken, the DSMB statistician will perform the final run of the DSMB data displays and prepare for the DSMB. For each DSMB meeting, the database will be extracted and the data listings and summary tables will be rerun. If the DSMB requests data clarification or further information, Omnicare CR will re-extract the data and rerun the listings and tables on the new data. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended.