Material Change to Organon's Current Manufacturing Operations

Material Change to Organon's Current Manufacturing Operations. A change or modification to the form, fit, function, method or process of manufacture or production of the Product hereunder which (x) would reasonably be expected to require any new regulatory filing(s) with respect to the Product and/or Organon's other customer's end products or (y) could affect the safety, efficacy or quality of the Product and/or Organon's other customer's end products