Common use of Regulatory Meetings Clause in Contracts

Regulatory Meetings. NVS will use good faith efforts to invite up to [***] representatives of HMI’s regulatory team to attend and act as non-participating observers at any substantive meetings relating to (a) Regulatory Submissions for Development of In-Vivo [***] Products with the FDA or EMA (including the following meetings, to the extent held by NVS: [***], and (b) Regulatory Submissions with respect to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of (a) and (b), to the extent (i) such meetings are scheduled in advance, (ii) HMI’s attendance is not prohibited by Applicable Law or the FDA or EMA; and (iii) such meetings do not involve Other Components. In addition, (A) attendance by HMI representatives will not prevent participation of a NVS representative due to restrictions imposed by the FDA or EMA on the number of attendees; and (B) NVS will not be obligated to change the schedule of such meetings in order to accommodate the schedule of HMI’s representatives. HMI will follow NVS’ reasonable instructions with respect to any such meeting that it attends, and will not discuss the contents of any such meeting with any Third Party or Regulatory Authority except as required by Applicable Law or authorized by NVS in writing.

Regulatory Meetings. NVS will use good faith efforts to invite up to [***] representatives of HMI’s regulatory team to attend and act as non-participating observers at any substantive meetings relating to (a) Regulatory Submissions for Development of In-Vivo [***] SCD Products with the FDA or EMA (including the following meetings, to the extent held by NVS: [***], and (b) Regulatory Submissions with respect to Manufacturing by HMI or its Designated CMO of Candidates and Products, in the case of each of (a) and (b), to the extent (i) such meetings are scheduled in advance, (ii) HMI’s attendance is not prohibited by Applicable Law or the FDA or EMA; and (iii) such meetings do not involve Other Components. In addition, (A) attendance by HMI representatives will not prevent participation of a NVS representative due to restrictions imposed by the FDA or EMA on the number of attendees; and (B) NVS will not be obligated to change the schedule of such meetings in order to accommodate the schedule of HMI’s representatives. HMI will follow NVS’ reasonable instructions with respect to any such meeting that it attends, and will not discuss the contents of any such meeting with any Third Party or Regulatory Authority except as required by Applicable Law or authorized by NVS in writing.