Common use of Regulatory Coordination Clause in Contracts

Regulatory Coordination. (i) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to each applicable Regulatory Authority with respect to each Product. The Lead Regulatory Party shall perform all such activities in accordance with the Joint Steering Committee-approved Development Plan, relevant Country Co-Commercialization Plans and pricing strategies and guidelines. (ii) The Parties shall establish procedures to ensure that the Parties exchange on a timely basis all necessary information to enable the Lead Regulatory Party to comply with all regulatory obligations on a global basis, including, without limitation, filing updates, pharmacovigilance filings and investigator notifications. The Parties shall provide to each other prompt notice of any approved Registration Filing.