Common use of Regulatory Filings and Approvals in the Territory Clause in Contracts

Regulatory Filings and Approvals in the Territory. Rhythm shall have the responsibility for, and have final decision-making authority with respect to applying for and obtaining Regulatory Approvals for each Product in the Territory which applications and approvals shall be held by and in the name of Rhythm. Camurus shall provide assistance as reasonably requested in (i) compiling an IND and NDA; (ii) providing support for meetings with Regulatory Authorities and (iii) responding to questions from the Regulatory Authorities on technical (as opposed to pricing) questions on the Product and Camurus shall be reimbursed for such work at Camurus FTE Costs and reimbursement of documented expenses. Rhythm shall pay all user fees and other costs required to obtain and maintain such Regulatory Approvals.