Common use of Interaction with Regulatory Authorities Clause in Contracts

Interaction with Regulatory Authorities. MITSUBISHI, its Affiliates or sublicensees will be the principal contact for and will otherwise take the lead role in all interactions with Regulatory Authorities concerning a Drug Product in the Territory. VERTEX, its Affiliates or VERTEX Licensees will be the principal contact for and will otherwise take the lead role in all interactions with Regulatory Authorities concerning Bulk Drug Substance or a Drug Product in the VERTEX Territory. Each Party will provide the other Party with prompt notice of all material correspondence and filings with a Regulatory Authority regarding Bulk Drug Substance or a Drug Product and, at the other Party’s request and at its expense, with copies of all such correspondence and filings.