Common use of Safety and Medical Clause in Contracts

Safety and Medical. Medical Monitoring (during business hours) The medical aspects of The Sponsor’s clinical program will be overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible for the following: • Addressing medical inquiries, internal or external • Reviewing of clinical documentation (protocol, draft CRF, sample informed consent form) • Project-specific medical training • Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) • Participating in team meetings • Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings • Reviewing study reports, regulatory submissions and study manuscripts Safety Coordinator The Coordinating Safety Officer assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. **** 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 406 of the Securities Act of 1933, as amended. SAE Reporting- (with initial descriptive summaries) Omnicare CR can provide initial descriptive summaries for all identified serious adverse events. The descriptive summaries will be written from information provided by the investigator on the SAE report forwarded to Omnicare CR at the time of the event. If significant follow-up information becomes available, the narrative will be updated accordingly. SAE Reporting (Follow-up/Revision Reports>2) Updates or revisions to an initial SAE report greater than two (2) will be billed per unit based upon the actual number of additional reports required. The Coordinating Safety Officer tracks all initial and follow-up reports. Safety Database Omnicare CR will develop the safety database for the Project. The database platform is the current version of the **** system. 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. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions (‘SUSARs’) to regulatory authorities as mandated by the European Clinical Trials Directive.

Safety and Medical. Medical Monitoring (during business hours) The medical aspects of The Sponsor’s clinical program will be overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible for the following: • Addressing medical inquiries, internal or external • Reviewing of clinical documentation (protocol, draft CRF, sample informed consent form) • Project-specific medical training • Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) • Participating in team meetings • Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings • Reviewing study reports, regulatory submissions and study manuscripts Safety Coordinator The Coordinating Safety Officer assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. **** 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 406 24b-2 of the Securities Exchange Act of 19331934, as amended. SAE Reporting- (with initial descriptive summaries) Omnicare CR can provide initial descriptive summaries for all identified serious adverse events. The descriptive summaries will be written from information provided by the investigator on the SAE report forwarded to Omnicare CR at the time of the event. If significant follow-up information becomes available, the narrative will be updated accordingly. SAE Reporting (Follow-up/Revision Reports>2) Updates or revisions to an initial SAE report greater than two (2) will be billed per unit based upon the actual number of additional reports required. The Coordinating Safety Officer tracks all initial and follow-up reports. Safety Database Omnicare CR will develop the safety database for the Project. The database platform is the current version of the **** system. 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. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions (‘SUSARs’) to regulatory authorities as mandated by the European Clinical Trials Directive.