Regulatory Inspection. NDD shall permit representatives of any regulatory agency having jurisdiction over the manufacture and/or marketing of the ASICs (or of any other product in which the ASIC is incorporated) to inspect its facilities in conjunction with the manufacture, testing, packaging, storage, handling and shipping of the ASICs. Further, NDD shall advise CMS immediately if NDD receives notice of an impending inspection or if an authorized agent of the FDA or other governmental agency visits any of NDD's manufacturing facilities concerning the ASICs. NDD shall furnish to CMS any report, including any FDA Form 483 notices (or comparable notices of other agencies), regulatory letters or similar documents received from such agency and the application of such report to the ASICs, if any, within seven (7) days of NDD's receipt of such report.
Appears in 4 contracts
Samples: License Agreement (Healthetech Inc), License Agreement (Healthetech Inc), License Agreement (Healthetech Inc)