Common use of Central Database Clause in Contracts

Central Database. Marinus shall maintain a central international Adverse Event database of Adverse Event and Serious Adverse Event reports associated with the Compound or a Covered Product (the “Central Database”). Not later thirty (30) days after the first clinical site initiation of a clinical study of Covered Product, Marinus shall provide NovaMedica with a copy of Marinus’s standard operating procedure (“SOP”) for safety-related reporting, including a detailed technical description of any data or information intended for inclusion and storage in, and retrieval from, the Central Database. Marinus shall periodically, but less than annually, review its SOP to ensure adequacy and compliance with then-applicable United States FDA and EMEA regulatory reporting requirements.