Common use of Regulatory Coordination Clause in Contracts

Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions (including supplements and amendments thereto) to each applicable Regulatory Authority with respect to the VEGF Product in the jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article 7. The Lead Regulatory Party shall perform all such activities in accordance with the Co-Development Plans, Global Co-Commercialization Plans, applicable Country Co-Commercialization Plans, and all applicable Laws. (b) 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 or supplements with Regulatory Authorities, pharmacovigilance filings, manufacturing supplements, and investigator notifications to Regulatory Authorities. The Parties shall provide to each other prompt written notice of any Approval of a VEGF