Notification of Regulatory Inspections. Patheon will notify Client within one Business Day 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 3 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)
Notification of Regulatory Inspections. Patheon will notify Client Indivior within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client Indivior 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 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspections by any governmental agency specifically involving the ProductsProduct. Patheon will also notify Client of receipt of any form 483’s or ’s, warning letters or any other significant regulatory action which or notice that questions Patheon’s quality assurance group determines compliance with cGMPs relating to operations at the Manufacturing Facility that could have an adverse impact on the Product, including the regulatory status of the ProductsProduct.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspections by any governmental agency Regulatory Authority specifically involving the Products. 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.. Master Manufacturing Services Agreement
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Notification of Regulatory Inspections. Patheon will shall notify Client Customer within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will shall also notify Client Customer 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 ProductsProducts within three Business Days from the receipt thereto.
Appears in 1 contract
Notification of Regulatory Inspections. Patheon will notify Client Client’s Head of Quality within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client Client's Head of Quality 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
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspections by any governmental agency specifically Authority involving the Products. Patheon will also notify Client of receipt of any form 483’s FDA Form 483 s, Establishment Inspection Reports, warning letters, or warning letters or any other significant regulatory action which inspectional findings that relate to the Products. Patheon shall promptly provide [redacted] copies of such inspection-related documents to Client and grant Client a reasonable opportunity to review and comment on Patheon’s quality assurance group determines could impact proposed responses to the regulatory status of the Productssame.
Appears in 1 contract
Samples: Product Agreement (TESARO, Inc.)
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day 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: Manufacturing Services Agreement (Horizon Pharma PLC)
Notification of Regulatory Inspections. Patheon will notify Client Depomed within one Business Day of any inspections by any governmental agency specifically involving the ProductsProduct or a general systems-based audit relating to Patheon’s conduct of the Manufacturing Services. Patheon will also notify Client Depomed 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 ProductsProduct.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Depomed Inc)