Notification of Regulatory Inspections. Patheon will notify Client within […***…] of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.
Appears in 2 contracts
Samples: Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.)
Notification of Regulatory Inspections. Patheon will notify Client within […***…] of any inspections by any governmental agency specifically involving the Products, and Client will have the right to be present at the Manufacturing Site (but not to participate in the inspection unless requested by the applicable authority) for all such inspections. Patheon will also notify Client of receipt of any form 483’s 483s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.
Appears in 1 contract
Notification of Regulatory Inspections. Patheon will notify Client within […***…] of any inspections by any governmental agency specifically involving the ProductsProduct. Patheon will also notify Client of receipt of any form 483’s 483s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could that would reasonably be expected to impact the regulatory status of the ProductsProduct or otherwise affect Patheon’s ability to carry out its obligations hereunder.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Nabriva Therapeutics PLC)
Notification of Regulatory Inspections. Patheon will notify Client within […***…] of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client of receipt of any form 483’s 's or warning letters or any other significant regulatory action which Patheon’s 's quality assurance group determines could impact the regulatory status of the Products.
Appears in 1 contract
Samples: Product Agreement (Horizon Therapeutics Public LTD Co)