definiens: means as to PATHEON, the end result of the analysis, review of Manufacturing Records, testing, and other activities as described in the Specificat ions, this Agreement and the Quality Agreement or a s otherwise required by GMP by which PATHEON certifie s t hat each Batch of Bulk and Finished Product was Manufactured in accordance with this Agreement, the Quality Agreement, SOPs, GMP and all other Applicable Laws, complies with the respective Speci fications and the requirements of any Regulatory Authority, an d is not adulterated or misbranded as those terms a re used in the FD&C Act . Release is demonstrated by issuance of certificates of Analysi s and compliance by PATHEON . With respect to RELYPSA, Release means the end result of the proces s by which RELYPSA det ermines that a Batch of Bulk for delivery to Third Parties or Finished Product m ay be distributed for its intended use