Common use of Regulatory Services Clause in Contracts

Regulatory Services. The Regulatory services involve elements needed to complete the relevant sections of the BLA as well as other documentation, and appropriate support for the various filings. This includes, but is not limited to: 2.2.1. preparation of the CMC update for the Phase 3 FDA package including a Rehovot-Beer Tuvia bridging document; 2.2.2. development and preparation of the requisite assays; 2.2.3. analytical method validation; 2.2.4. preparation of process validation documents; 2.2.5. annual report preparation (CMC, stability, process updates); 2.2.6. preparation of the CMC chapter of the BLA (process, methods, validations, specifications); 2.2.7. participation in meetings and calls with Savient (e.g. preparation for the end of Phase 2 [EOP21 meeting); 2.2.8. participation in meetings with regulatory authorities (e.g. the EOP2 meeting); and 2.2.9. support for any and all regulatory activities required for worldwide registrations.