Product Improvements; Prototypes Sample Clauses
Product Improvements; Prototypes. Periodically, Cerus may request that Fenwal manufacture prototype development or clinical lots, or request additional validation or qualification activities to obtain regulatory approvals. Fenwal will manufacture and supply prototype lots of the Sets, as Cerus may reasonably require in connection with any changes to Product Specifications. Allocation of costs for such changes shall be allocated in accordance with Section 4.4(b).
Product Improvements; Prototypes. The Parties shall meet at least twice per calendar year as part of the planned semi-annual management meetings to review and prioritize new products and product improvements, and anticipated changes. At Cerus’ request, Fenwal will provide cost estimates for projected development work. Cerus will reimburse Fenwal on a time and material basis for pre-approved out-of pocket expenses, engineering trials, prototype manufacturing for research and development (including costs of making changes or conducting activities described under Section 2.2(b)) and/or clinical trials, FTE support and materials).