Common use of Reference Safety Information Clause in Contracts

Reference Safety Information. Both Parties are responsible for establishing and maintaining Reference Safety Information in their respective territories based on the accumulated safety information of the Subject Product. However, since Strakan maintains the global safety database for the Product, Strakan shall be responsible for the development and maintenance of the Core Safety Information (CSI) for the Product in accordance with international safety standards. Strakan shall advise Aptalis when the CSI for the product is available or updated. Aptalis may not use the Product CSI as the Reference Safety Information for purpose of listedness determination or aggregrate safety reporting but other standard RSI as deemed appropriate. Both Parties shall exchange their respective Reference Safety Information upon the written request of the other Party.