Common use of Safety Database Clause in Contracts

Safety Database. It is assumed, that there is an existing database platform, the ****, within Omnicare CR for Sponsor. Therefore the present budgets include no Project set-up fees but only monthly database maintenance and date entry costs. The system is fully validated and compliant with all regulatory requirements for electronic storage of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. The pricing structure for the use of **** has been developed to be highly competitive for both **** SAE volume. **** 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.

Safety Database. It is assumed, that there is an existing database platform, the ****, within Omnicare CR for Sponsor. Therefore the present budgets include no Project set-up fees but only monthly database maintenance and date entry costs. The system is fully validated and compliant with all regulatory requirements for electronic storage of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. The pricing structure for the use of **** has been developed to be highly competitive for both **** SAE volume. **** 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.