Common use of Meetings with Regulatory Authorities Clause in Contracts

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 Markets outside the European Union. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetings.

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 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 prior written notice of any inMajor 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-person 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 or teleconference with minutes and summaries of all Major Meetings, as well as any significant written communications received from representatives of 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 Markets outside the European Union. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetingsrelating thereto.

Meetings with Regulatory Authorities. (a) Through Mylan shall have the completion of the POC Studies for the applicable Product (except the EOP2 Meeting, with respect right to any DCM1 Product), MyoKardia shall lead and present at each meeting and/or teleconference all meetings with Regulatory Authorities for such Product. During such periodregarding the Product within the Mylan Territory, except as required by Applicable Law, Sanofi and shall not initiate contact, or respond have the sole right to any inquiry from, any interact with Regulatory Authority Authorities with respect to the Product without first notifying MyoKardia in writing the Mylan Territory, except as follows: (i) Revance shall lead meetings with Regulatory Authorities regarding its Development activities under the Initial Development Plan, including the FDA Scientific Advice Meeting and obtaining MyoKardia’s written consent filing by Revance of certain INDs for such contact the Product with the FDA in accordance with Section 6.1, and (ii) Revance may interact with Regulatory Authorities with respect to the Products in the Mylan Territory to the extent that Revance is required, under Applicable Law or responsethe Supply Agreement or Quality Agreement, to interact with Regulatory Authorities as the manufacturer of the Product for the Mylan Territory. MyoKardia As reasonably requested by Mylan, Revance shall provide Sanofi with advance notification of any in-person meeting one (1) or teleconference more representatives from Revance to attend, and assist in the preparation for, meetings regarding the Product with the applicable Regulatory Authority in the Mylan Territory (as permitted by such Regulatory Authority) that are led by Mylan, subject to the confidentiality provisions set forth under Article 12 below. Mylan shall have two (2) or more representatives from Mylan attend, assist in the preparation for, and participate in the FDA Scientific Advice Meeting for the Product and any meeting with Regulatory Authorities that relates held by Revance related to the Development of any INDs filed by Revance for the Product as promptly as possible after such meeting has been scheduledin the Territory, but in no event less than (5) Business Days before subject to 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 meetingsconfidentiality provisions set forth under Article 12 below. (b) Starting Revance shall promptly provide Mylan with the EOP2 Meeting Revance’s (with respect to DCM1 Productsas applicable) and after the EOP2 Meeting (with respect to HCM1 Products applicable Regulatory Authority’s minutes, and HCM2 Products)any other resulting correspondence, each Party shall lead and present at each meeting and/or teleconference from any meetings with Regulatory Authorities for such (i) regarding the Product in such Party’s territory that occurred prior to (i.e., or that occur after) the Licensed Territory for Sanofi and the Retained Territory for MyoKardia), and the other Party shall not communicate with any Regulatory Authority Effective Date in the other Party’s territory without the prior written consent from such Party, except solely Mylan Territory or (ii) to the extent necessary the content of the resulting minutes is likely to comply materially affect or inform the Development or commercialization of the Product in the Mylan Territory, regarding the Products that occur outside of the Mylan Territory after the Effective Date. Mylan shall promptly provide Revance with Applicable Law. Notwithstanding Mylan’s (as applicable) and the foregoingapplicable Regulatory Authority’s minutes, MyoKardia shall lead the EOP2 Meeting and subsequent any other resulting correspondence, from any meetings and/or teleconferences with Regulatory Authorities for regarding the Products that occur hereunder in the Licensed Mylan Territory unless and until MyoKardia receives after 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 Effective Date, to the Development extent the content 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 resulting minutes is scheduled likely to occur; provided that if Sanofi is materially affect or inform the Party leading such regulatory interactions, such notification shall only apply to meetings development or teleconferences that relate to commercialization of the Development of any Product in the European Union or the Major Markets outside the European Union. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetingsRevance Territory.

Meetings with Regulatory Authorities. (a) Through the completion of the POC Studies for Except as otherwise set forth in this Agreement, the applicable Product (except the EOP2 MeetingRegulatory Responsible Party will be responsible for all meetings, with respect to any DCM1 Product)conferences, MyoKardia shall lead and present at each meeting and/or teleconference discussions with Regulatory Authorities for such Productor other applicable Governmental Authorities related to the receipt of Regulatory Approval and Reimbursement Approval to Commercialize the Licensed Products in the Field in the Territory. During such periodIf uniQure is the Regulatory Responsible Party, except as required by Applicable Lawthen uniQure will provide Partner with written notice of any scheduled material meeting, Sanofi shall not initiate contactconference, or respond discussion with a Regulatory Authority or other Governmental Authority in the Territory relating to any inquiry fromLicensed Product in the Field as soon as practicable and, any Regulatory Authority with respect upon such other Party’s written request, will, to the Product without first notifying MyoKardia extent practicable and permitted by the Governmental Authority in writing and obtaining MyoKardia’s written consent for the Territory, allow such contact other Party to attend such meeting, conference, or responsediscussion. MyoKardia shall provide Sanofi with advance notification of any in-person meeting or teleconference with If Partner is the Regulatory Authorities that relates Responsible Party, then Partner has sole discretion 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 allow uniQure 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 , conferences, or discussions, and will consider uniQure’s requests to attend in good ​ faith, if any of the EOP2 Meeting (with respect to DCM1 Products) and after the EOP2 Meeting (with respect to HCM1 Products and HCM2 Products)following topics are scheduled for discussion: data generated by uniQure that is required for receipt of Regulatory Approval, each Party shall lead and present at each meeting and/or teleconference with Regulatory Authorities for such Product in such PartyuniQure’s territory (i.e., Manufacturing of the Licensed Territory for Sanofi and the Retained Territory for MyoKardia)Products, uniQure’s chemistry, manufacturing, and control activities for the Licensed Products, or uniQure’s support for the approval of the Initial U.S. MAA or the Initial E.U. MAA, provided that Partner may limit the number of participants from uniQure to one subject matter expert per topic. If Partner is the Regulatory Responsible Party, then Partner may also reasonably request that uniQure attend such meetings, conferences, or discussions. The Regulatory Responsible Party will provide to the other Party shall not communicate with copies of any correspondence relating to such meetings, conferences, or discussions, including meeting requests, briefing materials or questions as soon as reasonably practicable, and in any case, no later than [*] after the Regulatory Authority in the other Responsible Party’s territory without the prior written consent from such Partyreceipt thereof, 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 Partner is the Party leading Regulatory Responsible Party, then Partner will only provide such regulatory interactions, such notification shall only apply to meetings or teleconferences that relate to the Development of any Product copies if uniQure was a participant in the European Union or the Major Markets outside the European Union. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetings, conferences, or discussions.