Manufacture of PR Product Clause Samples

Manufacture of PR Product. Santarus will manufacture PR Product in the Initial Supply, or cause PR Product in the Initial Supply to be manufactured, in accordance with Good Manufacturing Practices, Applicable Law, the Specifications, the Quality Agreement and the applicable PR Product Registration, as each may be amended from time to time. At the time that Santarus supplies PR Product to the carrier, such PR Product will not be adulterated or misbranded within the meaning of the FD&C Act.