Manufacturing Facilities. 13.1 The Licensee shall purchase or establish and maintain one or more manufacturing facilities for the manufacture of the Products at its own expense. 13.2 Both Parties agree and acknowledge that the manufacturing facilities may be used to manufacture products other than the Products and to manufacture the Products for Third Parties. This right must be exercised within five (5) years or it becomes non-exclusive as to the manufacture. Such manufacturing facility will be in compliance with internationally accepted standards for GMP, FDA, quality control and quality assurance. 13.3 With regard to a decision on making the investment to establish and maintain one or more manufacturing facilities for the manufacture of the Products, both Parties agree that, prior to the Licensee deciding to proceed with the establishment of the manufacturing facilities, (i) BTI has to provide the Licensee a forecast of its purchase orders of the Products; and (ii) They should agree on the price of the Products manufactured and supplied by the Licensee to BTI. 13.4 The Licensee shall be responsible for the maintenance and repair of all equipment used in the manufacture of the Products in accordance with applicable laws and consistent with good industry practice.
Appears in 3 contracts
Sources: License and Manufacturing Agreement (Boston Therapeutics, Inc.), License and Manufacturing Agreement (Boston Therapeutics, Inc.), License and Manufacturing Agreement (Boston Therapeutics, Inc.)