Interaction with Regulatory Authorities. Subject to Section 6.1(a), Roche shall be responsible for all interactions with Regulatory Authorities relating to Development in the Territory. Roche shall update Prothena as to all material communications with Regulatory Authorities on matters related to the Licensed Products. Roche will provide to Prothena any copies of material written communications [*]. To the extent allowed by Applicable Law and as is reasonably practicable due to the nature and urgency of meetings with Regulatory Authorities, Prothena shall have the right to participate in meetings with Regulatory Authorities throughout the Territory [*]. Upon request by Roche, Prothena shall provide reasonable support for Roche’s meetings with Regulatory Authorities in the Royalty Territory relating to the Licensed Products.
Appears in 2 contracts
Sources: License, Development, and Commercialization Agreement (Prothena Corp PLC), License, Development, and Commercialization Agreement (Prothena Corp PLC)