Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s representative (COR) as follows:
Appears in 3 contracts
Samples: Fixed Price (MediWound Ltd.), Paratek Pharmaceuticals, Inc., Fixed Price (MediWound Ltd.)
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s representative Representative (COR) as follows:
Appears in 3 contracts
Samples: CONTRAFECT Corp, T2 Biosystems, Inc., Summit Therapeutics PLC
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s 's representative (COR) as follows:
Appears in 1 contract
Samples: Contract (Siga Technologies Inc)
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s representative Representative (COR) as follows:
Appears in 1 contract
Samples: Attachment 1 (Gritstone Bio, Inc.)
Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA Contracting Officer’s 's representative (COR) as follows:
Appears in 1 contract
Samples: Emergent BioSolutions Inc.
