Example ContractsClausesRegulatory Meetings
Regulatory Meetings
Regulatory Meetings contract clause examples

Regulatory Meetings. Ji Xing shall provide [[Cytokinetics:Organization]] with advance notice for any meeting or discussion to be requested with any Regulatory Authority in the Territory related to the Product in accordance with Section 5.2 and shall notify [[Cytokinetics:Organization]] in writing promptly, but in any event within ​, after its receipt of written notice of any meeting or discussion with any Regulatory Authority in the Territory related to the Product. Ji Xing shall participate in such meeting or discussion as [[Cytokinetics:Organization]]’ representative, provided however that ​.

Regulatory Meetings. Each Party will provide the other Party with advance notice of any formal, scheduled meetings with any Regulatory Authority in its respective Territory (including any meetings related to the final positioning of labeling and safety claims within the original and subsequent regulatory submissions), and provide a brief description of the topics to be presented or discussed at each such meeting, in English. Each Party shall be solely responsible for responding to any material communications with Regulatory Authorities with respect to any Product(s) in its respective Territory; provided that, to the extent reasonably practicable, any such response shall be aligned with the Global Registration Strategy. Each Party may request the other Party to be present in any meeting with a Regulatory Authority in its respective Territory and, upon such request, such other Party shall use Commercially Reasonable Efforts to cause its appropriate representative(s) to assist the requesting Party in such meeting, whether in person or by teleconference. Promptly following any meeting with a Regulatory Authority with respect to a Product, the Party receiving notice for such meeting shall provide to the other Party the minutes of such meeting, in English.

Regulatory Meetings. The Lead Regulatory Party shall provide the other Party with reasonable advance notice of all substantive meetings with the Regulatory Authorities pertaining to a [[Unknown Identifier]] Co-Co Product, or with as much advance notice as practicable under the circumstances. Upon the other Party’s request, the Lead Regulatory Party shall include the other Party in the preparation and strategy for such substantive meeting and in any discussions and actions relating to the outcome thereof. The other Party shall participate (including attending in person as applicable) in all such meetings if required by the applicable Regulatory Authority, and otherwise, to the extent permitted by Applicable Laws and by the applicable Regulatory Authorities, shall have the right to participate provided that such participation shall be limited to up to two (2) representatives of the other Party.

Regulatory Meetings. Ji Xing shall provide [[Cytokinetics:Organization]] with advance notice for any meeting or discussion to be requested with any Regulatory Authority in the Territory related to the Product in accordance with Section 5.2 and shall notify [[Cytokinetics:Organization]] in writing promptly, but in any event within ​, after its receipt of written notice of any meeting or discussion with any Regulatory Authority in the Territory related to the Product. Ji Xing shall participate in such meeting or discussion as [[Cytokinetics:Organization]]’ representative, provided however that ​.

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.

Regulatory Meetings. Until such time as Lian obtains Regulatory Approval for the Licensed Product in the Field in the Territory, to the extent legally permissible and practicable, Lian will provide Lyra with reasonable prior written notice of all substantive meetings with Regulatory Authorities in the Territory regarding the Licensed Product if permitted by applicable Law or the Regulatory Authority. Lyra will have the right to request to be present as an observer at or participant in all such meetings with Regulatory Authorities to the extent permitted under applicable Law​, and Lian will use reasonable efforts to permit Lyra to be present at, or participate in, any such meetings, as applicable.

Regulatory Meetings. Kyorin will provide aTyr with reasonable advance notice of all substantive meetings with the Governmental Authorities in the Kyorin Territory pertaining to each Licensed Product, or with as much advance notice as practicable under the circumstances. Kyorin will use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit aTyr to have, at aTyr’s expense, mutually acceptable representatives of aTyr attend, solely as a non-participating observer, material, substantive meetings, including pre-IND and end of Phase 2 Study meetings, with any Governmental Authorities within the Kyorin Territory pertaining to such Licensed Product; provided, however, that # if required by the Governmental Authority, attendance by aTyr will be permitted; # attendance by the representatives of aTyr will not prevent participation of a representative of Kyorin due to restrictions imposed by Regulatory Agencies on the number of attendees; and # Kyorin will not be obligated to change the schedule of such meeting in order to accommodate the schedule of aTyr’s representatives.

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. 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. 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.

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