Common use of Meetings with Regulatory Authorities Clause in Contracts

Meetings with Regulatory Authorities. On a current and ongoing basis, each Party (through the JPT) shall provide the other Party with a list and schedule of any in-person meeting or material teleconference with Regulatory Authorities (or related advisory committees) in the Licensee Territory planned for [***] that relates to the Development of the Compound and Products under the Development Plan in the Licensee Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such Calendar Quarter and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Product in the Licensee Territory. Each Party shall be solely responsible for any communications with any Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory. With respect to Regulatory Meetings for which Licensee is the responsible Party, Ovid shall have the right to comment in preparation for all such Regulatory Meetings and the right, but not the obligation, to have its representatives attend any such Regulatory Meetings.

Meetings with Regulatory Authorities. On a current and ongoing basis, each Party (through the JPT) shall provide the other Party with a list and schedule of any in-person meeting or material teleconference with the Regulatory Authorities (or related advisory committees) in the Licensee Territory planned for [***] the next Calendar Quarter that relates to the Development of the Compound and Products under the Development Plan GDP in the Licensee Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such Calendar Quarter and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Product in the Product. Licensee Territory. Each Party shall be solely responsible for any communications with any the Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory. With respect to Regulatory Meetings for which Licensee is the responsible Party, Ovid and Exelixis shall have the right to comment provide input in preparation for all such Regulatory Meetings and and, with the consent of Licensee, not to be unreasonably withheld, the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the other Party, not participate in) the Regulatory Meetings. Licensee shall have these same rights with respect to any such Regulatory MeetingsMeetings before such Regulatory Filings are transferred to Licensee under Sections 5.1(b) and 5.2.

Meetings with Regulatory Authorities. On a current and ongoing basis, each Party (through the JPT) shall provide the other Party with a list and schedule of any in-person meeting or material teleconference with the Regulatory Authorities (or related advisory committees) in the Licensee Territory planned for [***] the next Calendar Quarter that relates to the Development of the Compound and Products under the Development Plan GDP in the Licensee Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such Calendar Quarter and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Product in the Product. Licensee Territory. Each Party shall be solely responsible for any communications with any the Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory. With respect to Regulatory Meetings for which Licensee is the responsible Party, Ovid and Exelixis shall have the right to comment provide input in preparation for all such Regulatory Meetings and and, with the consent of Licensee, not to be unreasonably withheld, the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the other Party, not participate in) the Regulatory Meetings. Licensee shall have these same rights with respect to any such Regulatory Meetings.Meetings before such Regulatory Filings are transferred to Licensee under Sections 5.1(b) and 5.2. (a)