Common use of Regulatory Meetings Clause in Contracts

Regulatory Meetings. Novartis will use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Surface to have, at Surface’s expense, mutually acceptable representatives of Surface attend, solely as a non-participating observer, material, substantive meetings including pre-IND meetings, with the Governmental Authorities pertaining to Research of such T1 Licensed Product; provided, however, that (a) if required by the Governmental Authority, attendance by Surface will be permitted; (b) attendance by Surface representatives will not prevent participation of a Novartis representative due to restrictions imposed by Regulatory Agencies on the number of attendees; and (c) Novartis will not be obligated to change the schedule of such meeting in order to accommodate the schedule of Surface’s representatives. Novartis will provide Surface, through the JDC, with [***] updates of substantive meetings with the Governmental Authorities in the Novartis Territory pertaining to the Development of each T1 Licensed Product. For clarity, Novartis has the right to attend, at Novartis’ expense, any material, substantive meetings held by or on behalf of Surface, including pre-IND meetings, with the Governmental Authorities pertaining to such T1 Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Regulatory Meetings. Novartis Each Party will provide the other Party with reasonable advance notice of all substantive meetings with the Governmental Authorities in its Territory pertaining to each Regional Licensed Product, or with as much advance notice as practicable under the circumstances. Each Party will use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Surface the other Party to have, at Surfacethe other Party’s expense, mutually acceptable representatives of Surface the other Party attend, solely as a non-participating observer, material, substantive meetings meetings, including pre-IND and end of Phase 2 Study meetings, with the Governmental Authorities within either its or the other Party’s Territory pertaining to Research of such T1 Regional Licensed Product; provided, however, that (a) if required by the Governmental Authority, attendance by Surface the other Party will be permitted; (b) attendance by Surface the representatives of the other Party will not prevent participation of a Novartis representative of the Party in charge of its Territory due to restrictions imposed by Regulatory Agencies on the number of attendees; and (c) Novartis neither Party will not be obligated to change the schedule of such meeting in order to accommodate the schedule of Surfacethe other Party’s representatives. In the event that Surface exercises its rights pursuant to Section 7.2.1.1 to files INDs in the Novartis Territory, then prior to the acceptance or approval of the IND, Surface will provide Surface, through the JDC, Novartis with [***] updates reasonable advance notice of all substantive meetings with the Governmental Regulatory Authorities in the Novartis Territory pertaining to the Development of each T1 such Regional Licensed Product. For clarity, Novartis has the right to attend, at Novartis’ expense, any material, substantive meetings held by or on behalf of Surface, including pre-IND meetings, with the Governmental Authorities pertaining to such T1 Licensed Product. as much advance notice as practicable CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. under the circumstances. Surface will use reasonable efforts, to the extent reasonably practicable, to permit Novartis to have, at Novartis’s expense, mutually acceptable representatives of Novartis to attend, as full and equal participants, material, substantive meetings, including pre-IND meetings, with Regulatory Authorities in the Novartis Territory pertaining to such Regional Licensed Product.

Regulatory Meetings. Novartis will use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Surface to have, at Surface’s expense, mutually acceptable representatives of Surface attend, solely as a non-participating observer, material, substantive meetings meetings, including pre-IND meetings, with the Governmental Authorities CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pertaining to Research of such T1 Global Licensed ProductProduct should such meetings be deemed necessary by Novartis; provided, however, that (a) if required by the Governmental Authority, attendance by Surface will be permitted; (b) attendance by Surface representatives will not prevent participation of a Novartis representative due to restrictions imposed by Regulatory Agencies on the number of attendees; and (c) Novartis will not be obligated to change the schedule of such meeting in order to accommodate the schedule of Surface’s representatives. Novartis will provide Surface, through the JDC, with [***] updates of substantive meetings with the Governmental Authorities in the Novartis Territory pertaining to the Development of each T1 Global Licensed Product. For clarity, Novartis has the right to attend, at Novartis’ expense, any material, substantive meetings held by or on behalf of Surface, including pre-IND meetings, with the Governmental Authorities pertaining to such T1 Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Regulatory Meetings. Novartis will Each Party shall provide the other Party with reasonable advance notice of all substantive meetings with the Government Authorities in its Territory pertaining to each Regional Licensed Product, and Alnylam shall provide Genzyme with reasonable advance notice of all substantive meetings with the Governmental Authorities in the Genzyme Territory pertaining to each Regional Licensed Product, or with as much advance notice as practicable under the circumstances. Each Party shall use Commercially Reasonable Effortsreasonable efforts, to the extent reasonably practicable, to permit Surface the other Party to have, at Surfacethe other Party’s expense, mutually acceptable representatives of Surface the other Party to attend, solely as a non-participating observer, material, substantive meetings meetings, including pre-IND and end of Phase II Study meetings, with the Governmental Authorities within such Party’s Territory pertaining to Research of such T1 Regional Licensed Product; provided, however, that (a) if required by the Governmental Authority, attendance by Surface will be permitted; (b) attendance by Surface representatives will not prevent participation of a Novartis representative due to restrictions imposed by Regulatory Agencies on the number of attendees; and (c) Novartis will not neither Party shall be obligated to change the schedule of such a meeting in order to accommodate the schedule of Surfacethe other Party’s representatives. Novartis will Prior to the acceptance or approval of the IND and the first dosing of the first patient in the first Phase III Study of a Regional Licensed Product by Alnylam in a country in the Genzyme Territory, Alnylam shall provide Surface, through the JDC, Genzyme with [***] updates reasonable advance notice of all substantive meetings with the Governmental Regulatory Authorities in the Novartis Genzyme Territory pertaining to the Development of each T1 such Regional Licensed Product, or with as much advance notice as practicable under the circumstances. For clarityAlnylam shall use reasonable efforts, Novartis has to the right extent reasonably practicable, to permit Genzyme to have, at Genzyme’s expense, mutually acceptable representatives of Genzyme to attend, at Novartis’ expenseas full and equal participants, any material, substantive meetings held by or on behalf of Surfacemeetings, including pre-IND and end of Phase II Study meetings, with Regulatory Authorities in the Governmental Authorities Genzyme Territory pertaining to such T1 Regional Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Regulatory Meetings. Novartis Each Party will provide the other Party with reasonable advance notice of all substantive meetings with the Governmental Authorities in its Territory pertaining to each Regional Licensed Product, or with as much advance notice as practicable under the circumstances. Each Party will use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Surface the other Party to have, at Surfacethe other Party’s expense, mutually acceptable representatives of Surface the other Party attend, solely as a non-participating observer, material, substantive meetings meetings, including pre-IND and end of Phase 2 Study meetings, with the Governmental Authorities within either its or the other Party’s Territory pertaining to Research of such T1 Regional Licensed Product; provided, however, that (a) if required by the Governmental Authority, attendance by Surface the other Party will be permitted; (b) attendance by Surface the representatives of the other Party will not prevent participation of a Novartis representative of the Party in charge of its Territory due to restrictions imposed by Regulatory Agencies on the number of attendees; and (c) Novartis neither Party will not be obligated to change the schedule of such meeting in order to accommodate the schedule of Surfacethe other Party’s representatives. In the event that Surface exercises its rights pursuant to Section 7.2.1.1 to files INDs in the Novartis Territory, then prior to the acceptance or approval of the IND, Surface will provide Surface, through the JDC, Novartis with [***] updates reasonable advance notice of all substantive meetings with the Governmental Regulatory Authorities in the Novartis Territory pertaining to the Development of each T1 such Regional Licensed Product, or with as much advance notice as practicable under the circumstances. For claritySurface will use reasonable efforts, to the extent reasonably practicable, to permit Novartis has the right to have, at Novartis’s expense, mutually acceptable representatives of Novartis to attend, at Novartis’ expenseas full and equal participants, any material, substantive meetings held by or on behalf of Surfacemeetings, including pre-IND meetings, with Regulatory Authorities in the Governmental Authorities Novartis Territory pertaining to such T1 Regional Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.