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. 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. 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.

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.

Communications with Regulatory Authorities. Each Party will notify the other Party, including a brief description in English, of the principal issues raised in each material communication with Regulatory Authorities with respect to each Licensed Product in the Kyorin Territory or that may have a material impact on the Kyorin Territory within ​ Business Days after receipt thereof. Upon a Party’s request, the other Party will provide to such requesting Party, ​: # a summary translation of such material communications in English, # complete copies of the original correspondence in their native language, or # a complete translation of such material communications in English, in each case of [(a) through (c)] within a reasonable period of time following such request. For the purposes of this [Section 5.1.2], “material communications” with Regulatory Authorities include meetings with Regulatory Authorities and Regulatory Authority questions or concerns with respect to significant issues in the Kyorin Territory or that may have a material impact on the Kyorin Territory, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., Serious Adverse Events, emerging safety signals), clinical or nonclinical findings affecting patient safety, lack of efficacy or receipt or denial of Regulatory Approval.

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.

Communications with Regulatory Authorities. Apellis will have sole responsibility for all communications with Regulatory Authorities with respect to the Trial and SFJ will not communicate with Regulatory Authorities. Notwithstanding the foregoing, or anything else contained herein to the contrary, Apellis agrees that the CEO or the CMO of SFJ shall be entitled to participate on a silent basis in all meetings with the FDA and the EMA during the Term and, to the extent practicable, SFJ shall be given the opportunity to review pre-meeting briefing materials. Apellis will provide the JSC and SFJ with copies of the minutes of all of the aforementioned meetings within ​ after Apellis receives the final minutes from the applicable Regulatory Authority.

Filings and Communications with Regulatory Authorities. Except as otherwise provided in this Agreement (including the Regulatory Approval Plan), Pint will be responsible for all Regulatory Filings made to obtain or maintain any Regulatory Approval for Product in the Territory and for all other written or oral communications made in connection with obtaining or maintaining any such Regulatory Approval.

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 and Filings with Regulatory Authorities. Under the oversight of the JDC and subject to [Section 3.6], vTv shall be responsible for preparing and filing all Regulatory Filings with respect to the Phase II MRCT. All Regulatory Filings with respect to the Phase II MRCT shall be filed in the name of vTv, to the extent permitted by applicable Laws, and vTv shall be responsible for all communications and other dealings with the Regulatory Authorities relating to the Phase II MRCT; provided, however, that vTv shall provide Huadong with reasonable advanced notice of all meetings, conferences, discussions or other communications (whether face-to-face or by teleconference) with a Regulatory Authority, or with any experts convened by a Regulatory Authority, in each case, in connection with the Phase II MRCT within ​ Business Days after the earliest of the occurrence, notice or scheduling of such meeting, including copies of all related documents and other relevant information relating to such meetings, conferences, discussions or other communications. Huadong shall have the right to have reasonable representation present at and to participate in such meetings, conferences, discussions and other communications. In addition, vTv shall promptly provide Huadong with: # copies of all regulatory correspondence to or from the Regulatory Authorities; # advance copies of Regulatory Filings and a reasonable opportunity to comment in advance thereon (which comments vTv shall consider in good faith and incorporate to the extent reasonable); and # reasonable responses to inquiries by Huadong regarding the Regulatory Filings and Regulatory Approvals for or with respect to any Product outside the Territory, including reasonable access to vTv’s personnel in connection with such inquiries. vTv shall promptly provide Huadong with copies of all Regulatory Filings and other documents and correspondence in connection with the Phase II MRCT after it has been submitted to, or received from, the Regulatory Authorities. vTv shall use Commercially Reasonable Efforts to implement procedures reasonably designed to avoid any failure to provide any material required to be provided to Huadong under this [Section 3.6(b)] and to cure any such failure promptly after its discovery.