Environmental Monitoring Program. Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the responsible person within Patheon’s quality unit. Any out of limit results will be managed appropriately in accordance with Patheon SOP’s. In any event, Cangene shall be notified if an unresolved adverse EM trend has been identified in advance of its next scheduled fill. Cangene shall have the right to determine whether or not to proceed with the fill.
Appears in 2 contracts
Sources: Manufacturing Services Agreement, Manufacturing Services Agreement (Aptevo Therapeutics Inc.)