Meetings with Regulatory Authorities. On a current and ongoing basis, each Party 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 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. Licensee shall be solely responsible for any communications with 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, and Exelixis shall have the right to provide input in preparation for all Regulatory Meetings 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 before such Regulatory Filings are transferred to Licensee under Sections 5.1(b) and 5.2.
Meetings with Regulatory Authorities. (a) Through the completion of the POC Studies for the applicable Product (except the EOP2 Meeting, with respect to any DCM1 Product), MyoKardia shall lead and present at each meeting and/or teleconference with Regulatory Authorities for such Product. During such period, except as required by Applicable Law, Sanofi shall not initiate contact, or respond to any inquiry from, any Regulatory Authority with respect to the Product without first notifying MyoKardia in writing and obtaining MyoKardia’s written consent for such contact or response. MyoKardia shall provide Sanofi with advance notification of any in-person meeting or teleconference with the Regulatory Authorities that relates to the Development of any Product as promptly as possible after such meeting has been scheduled, but in no event less than (5) Business Days before the meeting is scheduled to occur. Sanofi shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by MyoKardia, not participate in) such meetings.
(b) Starting with the EOP2 Meeting (with respect to DCM1 Products) and after the EOP2 Meeting (with respect to HCM1 Products and HCM2 Products), each Party shall lead and present at each meeting and/or teleconference with Regulatory Authorities for such Product in such Party’s territory (i.e., the Licensed Territory for Sanofi and the Retained Territory for MyoKardia), and the other Party shall not communicate with any Regulatory Authority in the other Party’s territory without the prior written consent from such Party, except solely to the extent necessary to comply with Applicable Law. Notwithstanding the foregoing, MyoKardia shall lead the EOP2 Meeting and subsequent meetings and/or teleconferences with Regulatory Authorities for the Products in the Licensed Territory unless and until MyoKardia receives the Continuation Payment from Sanofi. The Party leading such regulatory interactions shall provide the other Party with advance notification of any in-person meeting or teleconference with the Regulatory Authorities that relates to the Development of any Product as promptly as possible after such meeting has been scheduled, but in no event less than five (5) Business Days before the meeting is scheduled to occur; provided that if Sanofi is the Party leading such regulatory interactions, such notification shall only apply to meetings or teleconferences that relate to the Development of any Product in the European Union or the Major...
Meetings with Regulatory Authorities. Voyager shall provide Genzyme with reasonable advance notice of any pre-IND meetings or any other formal meeting or teleconference with any Regulatory Authority with respect to any Collaboration Product. Voyager shall use commercially reasonable efforts to permit Genzyme to have, at Genzyme’s expense, a mutually acceptable representative of Genzyme attend, solely as an observer, such pre-IND meetings or other formal meetings or teleconferences; provided, however, that Voyager shall not be obligated to change or re-schedule any such meeting in order to accommodate the schedule of Genzyme’s representatives.
Meetings with Regulatory Authorities. Awardee shall notify CEPI in writing of any material meetings with regulatory authorities at least five (5) Business Days in advance of such meetings, or if Awardee itself receives less than five (5) Business Days notice of such a meeting, as soon as practicable. CEPI or its designee may, at CEPI’s option, observe all material interactions between Awardee and regulatory authorities relating to the Project Vaccine. At CEPI’s reasonable request, Awardee shall request a meeting with regulatory authorities to address any significant unresolved issues.
Meetings with Regulatory Authorities. The Parties will mutually agree on the strategy for all meetings with Regulatory Authorities, including, but not limited to pre-IND meetings, end of Phase 2 meetings, scientific advice in the EU and the preparatory sessions therefor. The Regulatory Sub-Committee will mutually agree on the attendees (with Isis having up to three representatives and the goal of equal representation from Akcea andIsis), each attendee’s role and responsibilities and the strategy for addressing the issues to be discussed with the Regulatory Authority for such meeting.
Meetings with Regulatory Authorities. Licensee shall be responsible for conducting all meetings and discussions and routine telephone communications with any Relevant Regulatory Authority, related to clinical studies, Approval applications and Approvals for the Licensed Product in the Territory; provided that Licensee shall use Commercially Reasonable and Diligent Efforts to conduct such meetings and discussions to facilitate the Approval of the Licensed Product in the Territory. Licensee will inform Cellegy and the Steering Committee early in advance of all meetings with such Relevant Regulatory Authorities and will keep Cellegy and the Steering Committee apprised of all material communications with such Relevant Regulatory Authorities. Cellegy or its designee shall be entitled to attend all meetings with Relevant Regulatory Authorities. If appropriate Cellegy, or Cellegy’s designee, will provide reasonable assistance and technical support for the preparation of and attendance at any relevant meeting with a Relevant Regulatory Authority.
Meetings with Regulatory Authorities. Agila shall timely inform Pfenex as soon as reasonably practicable of any meetings scheduled with any Regulatory Authority concerning any Collaboration Product. As reasonably requested in a timely manner, Agila shall allow representatives from Pfenex to participate in such meetings with any Regulatory Authority.
Meetings with Regulatory Authorities. On a current and ongoing basis, each Party shall provide the other Party with a list and schedule of any significant in-person meeting or teleconference with the Regulatory Authorities (or related advisory committees) in the Collaborator Territory planned for the next [ * ] that relates to the Development of the Compound and Products under the GDP in the Collaborator Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably practicable if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such [ * ] and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which is reasonably expected to affect efforts to obtain Regulatory Approval for the Product in its respective territory. Collaborator shall be solely responsible for any communications with 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 Collaborator Territory, and Exelixis shall have the right to provide input in preparation for all Regulatory Meetings and the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by Collaborator, not participate in) the Regulatory Meetings. Collaborator shall have these same rights with respect to any such Regulatory Meetings in the Collaborator Territory before such Regulatory Filings are transferred to Collaborator under Section 5.1(b).
Meetings with Regulatory Authorities. Following the Regulatory Transition Date, Gilead shall provide Galapagos with reasonable advance notice of all formal meetings and teleconferences with the FDA and EMA pertaining to any Licensed Product, or with as much advance notice as practicable under the circumstances. Gilead shall permit Galapagos to have, at Galapagos’ expense, two representatives of Galapagos attend as observer, such formal meetings and teleconferences with the FDA and EMA pertaining to such Licensed Product.
Meetings with Regulatory Authorities. Ono shall provide Repare with reasonable advance notice of all formal meetings and teleconferences with any Regulatory Authority pertaining to any Licensed Drug Candidate and Licensed Product, or with as much advance notice as practicable under the circumstances. Ono shall use reasonable efforts, to the extent reasonably practicable, to permit Repare to have, at Repare’s expense, mutually acceptable representatives of Repare attend as observers, such formal meetings and teleconferences with such Regulatory Authority pertaining to such Licensed Drug Candidate and Licensed Product; provided, however, that Ono shall not be obligated to change or re-schedule any such meeting in order to accommodate the schedule of Repare’s representatives.
