Manufacturing and Technology Transfer. Coronado shall have the right to assume, at its sole discretion, the existing manufacturing agreement with Polpharma Laboratories (the existing contract “Manufacturer”). Coronado can contract another third party manufacturer (also the “Manufacturer”) sufficiently far enough in advance of the anticipated Approval Date to manufacture all Product evaluation batches and complete all process validation of the Product. Following execution of a manufacturing and supply agreement with a Manufacturer, Revogenex shall provide Coronado and Manufacturer with all reasonable cooperation and assistance requested by Coronado (or its designated Affiliate) or Manufacturer in connection with transitioning the manufacture and supply of the Product to Manufacturer. Such cooperation shall include making reasonably available to Coronado personnel with appropriate technical and other expertise, as reasonably requested by Coronado, and providing any available information and documentation reasonably requested by Coronado, including all data, manufacturing technology, methods, information, documentation, materials and assistance reasonably necessary for the effective transfer. Coronado shall reimburse Revogenex for all reasonable out-of-pocket expenses (i.e. reasonable travel, meal and accommodation expenses) incurred by such personnel in connection with such a request of Coronado. Upon a successful technology transfer of the Product’s manufacturing process from Revogenex as contemplated by this Section 8.2 and as determined by Coronado in its reasonable discretion (“Technology Transfer”), at Coronado’s sole cost and expense, Coronado will cause Manufacturer to manufacture and supply the Product.
Manufacturing and Technology Transfer. 7.1 Manufacturing of PM8002 Licensed Products
Manufacturing and Technology Transfer
