Manufacturing Processes. Helsinn has furnished and will continue to furnish to Indevus during the term of this Agreement a copy of its current production procedures and in the Quality Technical Agreement the Parties will agree upon the equipment to be used to produce the API. Except as otherwise set forth in this Agreement, costs incurred by Helsinn as a result of any such changes or modifications requested by the FDA or by Indevus and relating solely to the production of the API will be borne by Indevus; costs for other changes affecting Helsinn’s compliance with cGMP or affecting other products generally will be borne by Helsinn.
Appears in 2 contracts
Sources: Api Supply Agreement, Api Supply Agreement (Indevus Pharmaceuticals Inc)