Regulatory Meetings and Correspondence. A Developing Party (with respect to the Clinical Trials for which it is responsible hereunder) shall have primary responsibility for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to a Licensed Compound or Licensed Product in the Territory. The Non-Developing Party shall be entitled to participate in all material or planned meetings and telephonic discussions between representatives of the Developing Party and the applicable Regulatory Authorities with respect to Licensed Compounds or Licensed Products in the Territory and, to the extent practicable, all other such meetings and discussions. For purposes of clarification, the Developing Party agrees to use Commercially Reasonable Efforts to notify the Non-Developing Party of planned meetings and telephonic discussions with such Regulatory Authorities and to use Commercially Reasonable Efforts to accommodate the schedule of the Non-Developing Party’s attendees at such meetings or discussions. The Developing Party shall be entitled to limit, but not entirely exclude, the number of representatives of the Non-Developing Party that attend meetings and telephonic discussions with applicable Regulatory Authorities in the Territory.
Regulatory Meetings and Correspondence. Except as otherwise provided in the Development Plans, Alexion shall be responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the Product, and XOMA will promptly refer any contacts or questions from Regulatory Authorities to the party so designated. Both Parties will be entitled to attend all meetings and, if reasonably practicable, telephone conferences with Regulatory Authorities. The regulatory groups of the Parties shall agree on the types of telephone conferences with Regulatory Authorities that the Parties will be required to notify the other Party of and permit the other Party to participate in.
Regulatory Meetings and Correspondence. Any key meetings with a Regulatory Agency regarding a Regulatory Filing with respect to a Joint Global Study shall be conducted by the Sponsor Party for its Sponsored Territory, with prior written notification to the other Party when practicable such that the other Party will have the opportunity to be present with one (1) representative as an observer. Unless required to comply with Applicable Laws, the Party that is not the Sponsor Party shall not, without the prior written approval of the Sponsor Party, correspond or communicate with any Regulatory Agency in the applicable Sponsored Territory.
Regulatory Meetings and Correspondence. (i) Merus shall be responsible for interfacing, corresponding and meeting with the FDA with respect to Program 1 Product in the United States. Incyte shall be responsible for interfacing, corresponding and meeting with: (A) all Regulatory Authorities with [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Regulatory Meetings and Correspondence. The Lead Regulatory Party shall be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to each Product. To the extent practicable in the Novartis Territory and the Major EU Countries, and in all cases in the U.S. Territory, the other Party shall have the right to have a reasonable number of representatives participate in all material meetings and telephone discussions between representatives of the Lead Regulatory Party and applicable Regulatory Authorities with respect to each Product.
Regulatory Meetings and Correspondence. (i) Lilly shall be responsible for interfacing, corresponding and meeting with the FDA, EMEA, MHLW and other Regulatory Authorities with respect to Licensed Products in the Field in the Territory.
Regulatory Meetings and Correspondence. Up to the FAAH Transition Date the following shall apply: (i) Infinity shall be responsible for interfacing, corresponding and meeting with the FDA with respect to FAAH Products in the Territory; (ii) Purdue shall have the right to have a senior, experienced employee, reasonably acceptable to Infinity, participate as an observer in meetings with the FDA with respect to FAAH Products and shall be provided with advance access to Infinity’s materials prepared for such meetings; (iii) Infinity shall provide Purdue with copies of any material submissions and correspondence with the FDA relating to Development of the FAAH Products, and shall use reasonable efforts to provide Purdue with copies of any other submissions and correspondence with the FDA relating to Development of the FAAH Products; (iv) Purdue shall have the right to review and comment upon any material submissions and correspondence with the FDA related to the FAAH Products and meetings with the FDA; (v) Infinity shall respond within a reasonable time frame to all reasonable inquiries by Purdue with respect to such submissions and correspondence; and (vi) Infinity shall provide Purdue, as soon as practicable, with meeting minutes from any meetings with the FDA concerning the FAAH Products.
Regulatory Meetings and Correspondence. MxxxxxXxxxx shall be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to each Patent. Kef shall execute such notices, powers of attorney, acknowledgments, consents and other instruments as MxxxxxXxxxx may reasonably request to authorize MxxxxxXxxxx to act on Kef’s behalf for all actions before and communications with Regulatory Authorities and other Governmental Authorities, including the United States Patent and Trademark Office, as shall be necessary and appropriate to enable MxxxxxXxxxx to perform the Regulatory Obligations.
Regulatory Meetings and Correspondence. The party so designated in the Development Plan covering a particular Collaboration Product shall be responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to such Collaboration Product, and the other party will promptly refer any contacts or questions from Regulatory Authorities to the party so designated. Both parties will be entitled to attend all meetings and, if reasonably practicable, telephone conferences with Regulatory Authorities.
Regulatory Meetings and Correspondence. (i) Incyte shall be responsible for interfacing, corresponding and meeting with the FDA with respect to JAK Licensed Products in the JAK Field in the Incyte Territory. Novartis shall be responsible for interfacing, corresponding and meeting with: (i) the EMEA, MHLW and other Regulatory Authorities with respect to the JAK Licensed Products in the JAK Field in the Novartis JAK Territory and (ii) FDA, EMEA, MHLW and other Regulatory Authorities with respect to the c-MET Licensed Products in the c-MET Field in the Novartis Territory. [***] Confidential material redacted and filed separately with the Commission.
