Common use of Study Management Clause in Contracts

Study Management. The overall management of the study will be the responsibility of the Senior Clinical Trial Manager (CTM). The Senior CTM will oversee and coordinate the management of the study as well as oversee the study specific CTM. This oversight will ensure consistency and allow VIVUS Study Management to have one primary contact for the Qnexa program. The Medpace CTM assigned to OB-301 will work closely with the VIVUS Study Manager, Medpace Medical Expert, and VIVUS Clinical Leader to address protocol questions and interpretations while maintaining close oversight of study-related processes and documents. The OB-301 CTM will supervise all Clinical Research Associates (CRAs) and Project Coordinator assigned to the project. The Project Coordinator will be responsible for day-to-day study management functions, including the generation of status reports, organization of supplies, generation and compilation of newsletters, and input of all study information into the ClinTrak® Study Management System, a web-based, proprietary research management system designed by Medpace. The Project Coordinator will organize teleconferences and team meetings, including the compilation of agendas and meeting minutes. The Study Start-Up Manager and Study Start-Up Coordinators will work closely with the CTM and Project Coordinator to ensure sites become active in the most time effective manner. The Medpace Contracts Attorney will be responsible for the execution of Investigator contracts (upon VIVUS defined process). The Contracts Attorney will work closely with the Start-Up Manager and Medpace CTM to ensure contracts are executed in a timely manner. The Medpace Medical Expert assigned to this project will work closely with the VIVUS Clinical Leader. The Medpace Medical Expert will assist with protocol design and medical interpretation of entry criteria and adverse events (AEs). The Medical Expert will also be involved in the training of CRAs and other staff members participating in the

Study Management. The overall management of the study will be the responsibility of the Senior Clinical Trial Manager (CTM). The Senior CTM will oversee and coordinate the management of the study as well as oversee the study specific CTM. This oversight will ensure consistency and allow VIVUS Study Management to have one primary contact for the Qnexa program. The Medpace CTM assigned to OB-301 OB-303 will work closely with the VIVUS Study Manager, Clinical Leader and Medpace Medical Expert, and VIVUS Clinical Leader Expert to address protocol questions and interpretations while maintaining close oversight of study-related processes and documents. The OB-301 OB-303 CTM will supervise all Clinical Research Associates (CRAs) and Project Coordinator Coordinators assigned to the project. The Project Coordinator Coordinators will be responsible for day-to-day study management functions, including the generation of status reports, organization of supplies, generation and compilation of newsletters, and input of all study information into the ClinTrak® Study Management System, a web-based, proprietary research management system designed by Medpace. The Project Coordinator Coordinators will organize teleconferences and team meetings, including the compilation of agendas and meeting minutes. The Study Start-Up Manager and Study Start-Up Coordinators will work closely with the CTM and Project Coordinator Coordinators to ensure sites become active in the most time effective manner. The Medpace Contracts Attorney will be responsible for the execution of Investigator contracts (upon VIVUS defined process). The Contracts Attorney will work closely with the Start-Up Manager and Medpace CTM to ensure contracts are executed in a timely manner. The Medpace Medical Expert assigned to this project will work closely with the VIVUS Clinical LeaderLeader . The Medpace Medical Expert will assist with protocol design and medical interpretation of entry criteria and adverse events (AEs). The Medical Expert will also be involved in the training of CRAs and other staff members participating in the

Study Management. The overall management of the study will be the responsibility of the Senior Clinical Trial Manager (CTM). The Senior CTM will oversee and coordinate the management of the study as well as oversee the study specific CTM. This oversight will ensure consistency and allow VIVUS Study Management to have one primary contact for the Qnexa program. The Medpace CTM assigned to OB-301 OB-302 will work closely with the VIVUS Study Manager, Medpace Medical Expert, and VIVUS Clinical Leader to address protocol questions and interpretations while maintaining close oversight of study-related processes and documents. The OB-301 OB-302 CTM will supervise all Clinical Research Associates (CRAs) and Project Coordinator Coordinators assigned to the project. The Project Coordinator Coordinators will be responsible for day-to-day study management functions, including the generation of status reports, organization of supplies, generation and compilation of newsletters, and input of all study information into the ClinTrak® Study Management System, a web-based, proprietary research management system designed by Medpace. The Project Coordinator Coordinators will organize teleconferences and team meetings, including the compilation of agendas and meeting minutes. The Study Start-Up Manager and Study Start-Up Coordinators will work closely with the CTM and Project Coordinator Coordinators to ensure sites become active in the most time effective manner. The Medpace Contracts Attorney will be responsible for the execution of Investigator contracts (upon VIVUS defined process). The Contracts Attorney will work closely with the Start-Up Manager and Medpace CTM to ensure contracts are executed in a timely manner. The Medpace Medical Expert assigned to this project will work closely with the VIVUS Clinical Leader. The Medpace Medical Expert will assist with protocol design and medical interpretation of entry criteria and adverse events (AEs). The Medical Expert will also be involved in the training of CRAs and other staff members participating in thethe project. The Medical Expert will review and approve the coding of concomitant medications, medical histories, AEs, and will provide the medical context for the statistical analysis and medical writing. The Medical Expert will assist in the review of the protocol, train Medpace personnel internally as to the background of the study compound and design of the study, participate in the project teleconferences and meetings, work hand-in-hand with the OB-302 CTM, and have heavy involvement in the clinical study report. The Medical Expert’s role and decision making rights are dictated by VIVUS (e.g. inclusion/exclusion of patients, discussions with Investigators about withdrawing a patient, etc.). This decision making power often times reduces the oversight needed by the sponsor. For questions the OB-302 CTM is not comfortable answering, she will contact the Medical Expert for guidance. Obviously, VIVUS will be involved in study oversight based on pre-defined terms with the VIVUS Clinical Development Team. The Medpace Medical Expert is available 24 hours a day, 7 days a week via the Medpace Project Helpline.