Regulatory Affairs. 8.3.1 ORPHAN is responsible for ensuring all appropriate regulatory filings and export documentation are filed with Regulatory Agencies prior to shipment/human administration.
Appears in 2 contracts
Samples: Technical Services Agreement (Jazz Pharmaceuticals Inc), Xyrem Supply Agreement (Jazz Pharmaceuticals Inc)
Regulatory Affairs. 8.3.1 ORPHAN is responsible for ensuring all appropriate regulatory filings and import/export documentation are filed with Regulatory Agencies regulatory agencies prior to shipment/human administration.
Appears in 2 contracts
Samples: Development and Supply Agreement (Jazz Pharmaceuticals Inc), Development and Supply Agreement (Jazz Pharmaceuticals Inc)