Common use of Adverse Drug Events Clause in Contracts

Adverse Drug Events. Each Party shall promptly report to the other Party any adverse event observed during any use of a Product. Prior to the first commercial sale of a Product in the Territory, the Parties shall in good faith enter into a data safety exchange agreement consistent with applicable law and regulatory requirements and practices in the United States and European Union.

Adverse Drug Events. Each Party shall promptly shall, in a timely fashion in accordance with the Data Safety Exchange Agreement attached as Schedule 7.4 attached hereto, report to the other Party any adverse event observed during any use of a Product. Prior to the first commercial sale of a Product in the Territory, the Parties shall in good faith enter into a data safety exchange agreement consistent with applicable law and regulatory requirements and practices in the United States and European Union.