Communications with Regulatory Authorities. Except as provided in Section 4(C), any and all other communications from and to Regulatory Authorities related to the manufacture of Bulk Drug Product to be supplied under this Agreement will be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Takeda and Company.

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 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.

Interactions with Regulatory Authorities. Apellis shall be responsible for the preparation and filing of any Regulatory Submissions and for all contacts and communications with any Regulatory Authorities with respect to matters specifically relating to Manufacture of SUNBRIGHT ​ or any component thereof. NOF shall notify Apellis immediately (and in no event later than ​) after NOF

Meetings with Regulatory Authorities. Poseida shall provide Roche with prior written notice of any substantive meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority relating to any Therapeutic Product for such Therapeutic Program, within ​ after Poseida first receives notice of the scheduling of such meeting (or within such shorter period as may be necessary) in order to give Roche a reasonable opportunity to have a reasonable number, but at least ​ representatives attend such meeting. Roche shall have the right, but not the obligation, to attend and participate in all such meetings (including substantive preparatory pre-meetings with Poseida therefor), to the extent permitted by applicable law and such Regulatory Authority.

Interactions with Regulatory Authorities. [[FibroGen:Organization]] will have the sole right to conduct all communications with Regulatory Authorities in the Territory related to the Licensed Compounds and Licensed Products, including all meetings, conferences, and discussions (including advisory committee meetings).

Communications with Regulatory Authorities. Except as provided in Section 4(C), any and all other communications from and to Regulatory Authorities related to the manufacture of Bulk Drug Product to be supplied under this Agreement will be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Takeda and Company.

Interactions with Regulatory Authorities. As between the Parties, subject to this [Section 4.4(b)], Tracon shall be responsible for, at its sole cost and expense, responding to inquiries and correspondence from the applicable Regulatory Authorities with respect to Collaborative Product in the Field in the Collaborative Territory. Eucure (or its designee) shall have a right to participate (and Tracon may otherwise request Eucure to participate) in meetings with the Regulatory Authorities if it is reasonably likely that there would be discussions on the agenda about the Collaborative Product beyond the scope of Tracon’s Development of the Collaborative Product the Collaborative Territory (e.g., CMC matters, clinical data generated by Eucure). Following each substantive communication (whether by phone or in person) with a Regulatory Authority with respect to the Collaborative Product in the Field in the Collaborative Territory, Tracon shall prepare a record of such meeting in accordance with its standard business practices (e.g., written minutes) and provide to Eucure a copy of such record.

After the Effective Date, PTC shall be responsible for, and shall take the lead with respect to, all meetings, communications and other interactions with all of the Regulatory Authorities in the PTC Territory, and will deliver, or cause to be delivered, to Akcea for its review copies of all documents and communications received from Regulatory Authorities in the PTC Territory, and, to the extent practicable under the relevant circumstances (e.g., accelerated timeframes for responses or impromptu calls by regulators) will provide Akcea with a reasonable opportunity to review and comment on any such communications and related materials received by or to be submitted to any such Regulatory Authority (and PTC will not unreasonably refuse to implement any reasonable suggestions made by Akcea to such communications or materials). To the extent practicable under the relevant circumstances, Akcea (or, at Akcea’s request, Ionis Pharmaceuticals) will have the right to attend, and PTC will provide Akcea with written notice of and an invitation to, any meeting PTC has formally scheduled or has definitive plans to hold with a Regulatory Authority relating to a Product in the PTC Territory; provided, however, that should Akcea be unable to attend a meeting, PTC will provide a summary of the meeting reasonably promptly thereafter. Following the first meeting with a Regulatory Authority attended by Akcea ActiveUS 169009360v.1

Meetings with Regulatory Authorities. At Sana’s request and Beam’s agreement (not to be unreasonably withheld), Beam shall provide reasonable assistance to Sana in preparation for any in-person meeting or teleconference with a Regulatory Authority (or related advisory committees) or other request of a Regulatory Authority, in each case to the extent such assistance is reasonably required in order for Sana to seek or obtain Marketing Approval for Licensed Products, and provided that Beam will not be required to provide any Beam Confidential Information or Know-How beyond what is agreed pursuant to a Technology Transfer Plan. In the event that Beam agrees to provide any such assistance, Sana shall reimburse Beam, in accordance with Section 8.2, for those documented and agreed upon costs and expenses incurred by Beam in connection with conducting such activities.