Common use of Regulatory Meetings and Correspondence Clause in Contracts

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. 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. 2.3.4.