Common use of Notice of Regulatory Filing Requirements Clause in Contracts

Notice of Regulatory Filing Requirements. The Lead Regulatory Party shall provide to the other Party, within [ * ] of discovery or receipt thereof by the Lead Regulatory Party, notice of (i) any event with respect to any Collaboration Product that triggers any Regulatory Authority filing requirement, (ii) any additional requirements which the applicable Regulatory Authority may impose with respect to obtaining or maintaining Regulatory Approval for a Collaboration Product (including additional Clinical Trials), and (iii) all Regulatory Authority inquiries with respect to a Collaboration Product that require a response or for a which a response may be advisable. The JDC shall discuss in good faith and on a timely basis determine the most effective and expeditious means of responding to such Regulatory Authority filing requirements, additional requirements or inquiries.

Notice of Regulatory Filing Requirements. The Lead Regulatory Party shall provide to the other Party, within [ * [*] of discovery or receipt thereof by the Lead Regulatory Party, notice of (i) any event with respect to any Collaboration Product that triggers any Regulatory Authority filing requirement, (ii) any additional requirements which the applicable Regulatory Authority may impose with respect to obtaining or maintaining Regulatory Approval for a Collaboration Product (including additional Clinical Trials), and (iii) all Regulatory Authority inquiries with respect to a Collaboration Product that require a response or for a which a response may be advisable. The JDC shall discuss in good faith and on a timely basis determine the most effective and expeditious means of responding to such Regulatory Authority filing requirements, additional requirements or inquiries.