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. 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. 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. 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. 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. 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. Each Party shall provide the other Party with prior written notice of any Major Meeting promptly after the Party receives notice of the scheduling of such Major Meeting, when practicable, within such time period as may be necessary in order to give the other Party a reasonable opportunity to attend such Major Meeting. GPC Biotech shall be entitled to have reasonable representation present at, and subject to Section 2.4.6, to participate in at its expense, all such Major Meetings relating to the Licensed Product in the Licensee Territory; provided, however, that with respect to Major Meetings relating to Unilateral Activities of Licensee, GPC Biotech shall be entitled to attend at its expense all such Major Meetings strictly as a silent observer. Licensee shall be entitled to attend at its expense all such Major Meetings with the FDA relating to the Licensed Product in the GPC Biotech Territory strictly as a silent observer unless GPC Biotech otherwise agrees in writing to permit Licensee to participate actively in any such meeting; provided, however, that GPC Biotech shall have no obligation under this Section 2.4.5 to permit Licensee to attend any such Major Meeting to the extent it results from or otherwise relates to Unilateral Activities of GPC Biotech; provided, further, that in the event that GPC Biotech enters into an agreement with a GPC Biotech Counter-Party, GPC Biotech shall have no further obligation to permit Licensee to attend Major Meetings (to the extent GPC Biotech’s agreement with such GPC Biotech Counter-Party prohibits such attendance), except where the subject of such Major Meeting relates to matters that could reasonably be expected to have a material adverse effect on the Product Labeling in the Licensee Territory in which case Licensee shall continue to have the rights specified herein. The Parties, through the JDC, shall use reasonable efforts to agree in advance on the scheduling of such Major Meetings and, in the case of Major Meetings with respect to the Licensee Territory, on the objectives to be accomplished at, GPC Biotech’s active role with respect to, and the agenda for, such meetings. Each Party shall promptly forward to the other Party copies of all meeting minutes and summaries of all Major Meetings, as well as any significant written communications received from representatives of the Regulatory Authorities relating thereto.
Meetings with Regulatory Authorities. Otsuka shall provide Perception with reasonable advance notice of all formal meetings and formal teleconferences or videoconferences with any Regulatory Authority in the Otsuka Territory (and in the Perception Territory, solely with respect to any Ex-Otsuka Territory Study) relating to any Product, or with as much advance notice as practicable under the circumstances. To the extent not restricted or prohibited by Applicable Laws or the Regulatory Authority, Perception shall have the right, [***], to have up to [***] representatives of Perception attend, as observers, such formal meetings and formal teleconferences or videoconferences with such Regulatory Authority in the Otsuka Territory relating to any Product; provided that Otsuka shall not be obligated to change or re-schedule any such meeting in order to accommodate the schedule of Perception’s representatives and, if attendance by Perception representatives is not restricted or prohibited by Applicable Laws or the Regulatory Authority but would require Otsuka to reduce the number of required Otsuka participants at such meeting due to limitations on the number of attendees imposed by such Regulatory Authority, then only [***] shall be permitted to observe such meeting. Notwithstanding the foregoing, if Otsuka requests Perception to participate in any meetings with Regulatory Authorities in the Otsuka Territory (and in the Perception Territory solely with respect to any Ex-Otsuka Territory Study) for assistance to Otsuka, then [***]. If Perception requires an interpreter for its representatives attending any Regulatory Authority meeting in the Otsuka Territory (and in the Perception Territory solely with respect to any Ex-Otsuka Territory Study), Perception shall retain, [***], an interpreter who can provide simultaneous interpretation unless Perception’s participation in such meeting has been specifically requested by Otsuka, in which case [***].
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 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 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.
