Retained Samples. Helsinn will maintain a sample of API from each lot as required by applicable regulatory standards or as otherwise mutually agreed by Indevus and Helsinn. Helsinn will be responsible for maintaining and storing retention samples of the API as may be required by applicable regulatory standards and the Quality Technical Agreement. Helsinn shall provide Indevus with reasonable access to and portions of the retained samples upon Indevus’ request. Preservation samples/retained samples, as referred to herein, do not include samples retained for purposes of stability testing.
Appears in 2 contracts
Sources: Api Supply Agreement, Api Supply Agreement (Indevus Pharmaceuticals Inc)