Reconciliation of Reports. Quarterly, not later than thirty (30) days after the end of each calendar quarter, each party shall provide the other with a listing of all ICSRs exchanged and other potential safety related issues that were sent/received and entered into the global safety database, to enable each party to reconcile all reports received from the other party during the preceding calendar quarter, and to confirm that the safety data exchange process is functioning properly. Where discrepancies between the parties safety data are identified, each party agrees to inform the other party, to take reasonable steps to reconcile the data, and to take all reasonable actions to prevent reoccurrence. If the number of ICSRs reported to Novartis monthly exceeds 100 cases, reconciliation frequency will be carried out monthly (thirty days after the end of the calendar month).
Appears in 3 contracts
Sources: Manufacturing and Supply Agreement, Manufacturing and Supply Agreement (Gw Pharmaceuticals PLC), Manufacturing and Supply Agreement (Gw Pharmaceuticals PLC)