Common use of Safety Databases Clause in Contracts

Safety Databases. Partner will maintain a safety database in English for Clinical Trials for the Licensed Product conducted in the Territory under a Territory Development Plan, at its sole cost and expense. Partner will be responsible for: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to the Licensed Product for all Territory-Specific Clinical Trials or Global Clinical Trials conducted in the Territory; and (b) responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Product in the Territory. Partner will provide Kiniksa (i) real-time access to Partner’s safety database for the Licensed Product in the Territory, and (ii) upon Kiniksa’s request, query results from Partner’s safety database for the Licensed Product. As between the Parties, Kiniksa will maintain a global safety database for Global Clinical Trials for the Licensed Product conducted under each Global Development Plan at Kiniksa’s cost and expense.