Process Improvements. As required by 21 CFR Part 820 Sec. 820.50, Supplier shall not make significant changes to the Specifications, manufacturing process, tooling design, processing conditions, materials or manufacturing location of the Products without SI-BONE’s prior written consent. Notwithstanding the foregoing, SI-BONE will consider in good faith reasonable written requests by Supplier to change the materials or manufacturing process of the Products, provided SI-BONE shall make final determination on such change(s) in its sole discretion.
Appears in 3 contracts
Sources: Manufacturing Agreement (SI-BONE, Inc.), Manufacturing Agreement (SI-BONE, Inc.), Manufacturing Agreement (SI-BONE, Inc.)