Common use of Regulatory Communications and Meetings Clause in Contracts

Regulatory Communications and Meetings. Notwithstanding anything in Section 5 or elsewhere in the Agreement to the contrary, the Parties agree that during the Moderna Lead Period, Moderna will have primary responsibility for conducting communications with the TGA (and any other applicable Regulatory Authorities) that pertain to the RSV IND or relate to the performance of the RSV Phase I Study or otherwise relate to the Moderna RSV Lead Activities, including [***]. The Parties (through the JSC) will discuss the strategy and shall endeavor to mutually agree upon the objectives for any such meeting or conference call. If it is not possible to provide the JSC advance notice of any such meeting or conference call, Moderna shall thereafter provide Merck with a reasonably detailed summary of such meeting or conference call. Moderna shall promptly furnish Merck with copies of all correspondence or material Moderna provides to or receives from the TGA (or any other applicable Regulatory Authority), including [***]. To the extent there is a disagreement between Merck and Moderna within the JSC regarding [***] after each Party reasonably and in good faith considers the other Party’s comments on such matter, such disagreement shall be referred to the Executive Officers (or their designees, which designee is required to have decision-making authority on behalf of such Party), who will attempt in good faith to resolve such dispute by negotiation and consultation for a [***] day period following such referral. If, despite such efforts, agreement cannot be reached by the Executive Officers within such [***] day period, [***].