Interaction with Regulatory Authorities. After the Effective Date, each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Regulatory Authority regarding the Product, in respect of IMMEDICA, in the Territory and, in respect of LICENSOR, outside of the Territory. If such correspondence received by IMMEDICA is not in English, then such copy will include a summary in English of all material matters addressed thereby. IMMEDICA shall provide reasonable advance written notice to LICENSOR of all material meetings, conferences, or calls with Regulatory Authorities concerning the Product, and LICENSOR shall be permitted to have appropriate representatives attend all such meetings, conferences, or calls. With respect to the Product, IMMEDICA shall provide LICENSOR with copies of any materials relating to any material regulatory matter and, when reasonably practicable, shall provide copies of any documents to be presented to any Regulatory Authority in respect of such matters prior to their presentation thereto. The materials provided under this [Section 5] with respect to material interactions with any Regulatory Authority will be forwarded to the other Party promptly after receipt.

Meetings with Regulatory Authorities. [[3D Medicines:Organization]] shall lead all interactions with Regulatory Authorities in the [[3D Medicines:Organization]] Territory with respect to Licensed Products for use in the Field. [[3D Medicines:Organization]] shall keep [[Aravive:Organization]] reasonably informed of any material regulatory developments related to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory. At each regularly scheduled JSC meeting, [[3D Medicines:Organization]] shall provide [[Aravive:Organization]] with a list and schedule of any in-person meeting or teleconference with the applicable Regulatory Authorities (or related advisory committees) in the [[3D Medicines:Organization]] Territory planned for the next Calendar Quarter that relates to any Licensed Product in the Field. In addition, [[3D Medicines:Organization]] shall notify [[Aravive:Organization]] as soon as reasonably possible (but in no event later than ​ if possible) after [[3D Medicines:Organization]] becomes aware of any additional such meetings or teleconferences that become scheduled for such Calendar Quarter. [[Aravive:Organization]] shall provide all assistance and documentation reasonably requested by [[3D Medicines:Organization]] to prepare for any such meeting or teleconference, including making available competent personnel to attend any such meeting or teleconference at [[3D Medicines:Organization]]’ reasonable request (subject to reimbursement by [[3D Medicines:Organization]] of [[Aravive:Organization]]’s costs and expenses with respect thereto). To the extent permitted by applicable Laws and by the Regulatory Authorities (as reasonably determined by [[3D Medicines:Organization]]), [[Aravive:Organization]] shall have the right to participate (whether directly or through a representative) in all such meetings and teleconferences, at [[Aravive:Organization]]’s cost.

Meetings with Regulatory Authorities. Apollomics shall lead all interactions with Regulatory Authorities in the Apollomics Territory with respect to Licensed Products. Apollomics shall keep [[GlycoMimetics:Organization]] reasonably informed of any material regulatory developments related to Licensed Products in the Field in the Apollomics Territory. At each regularly scheduled JDC meeting, Apollomics shall provide [[GlycoMimetics:Organization]] with a list and schedule of any in-person meeting or teleconference with the applicable Regulatory Authorities (or related advisory committees) in the Apollomics Territory planned for the next Calendar Quarter that relates to any Licensed Product in the Field. In addition, Apollomics shall notify [[GlycoMimetics:Organization]] as soon as reasonably possible (but in no event later than five (5) Business Days if possible) after Apollomics becomes aware of any additional such meetings or teleconferences that become scheduled for such Calendar Quarter. To the extent permitted by Applicable Law and by the Regulatory Authorities (as reasonably determined by Apollomics), [[GlycoMimetics:Organization]] shall have the right to participate (whether directly or through a representative) in all such meetings and teleconferences, at [[GlycoMimetics:Organization]]’ cost. If such participation would result in the disclosure to [[GlycoMimetics:Organization]] of Apollomics’ Confidential Information unrelated to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering such unrelated subject matter.

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.

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.

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. [[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).

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 Kite’s request, Sangamo shall provide input to Kite in preparation for any in-person meeting or teleconference with a Regulatory Authority (or related advisory committees), and shall provide assistance to Kite in responding to any request of a Regulatory Authority that relates to any Licensed Product, ​.

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.