Common use of Notification of Regulatory Inspections Clause in Contracts

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: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)

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Notification of Regulatory Inspections. Patheon will notify Client within [***…] of any inspections by any Authority or other 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 ProductsProducts and shall promptly provide Client with Patheon’s plan to correct any deficiencies identified by such Authority (which may be redacted to protect any confidential information of Patheon or any Third Party) and diligently pursue such corrections.

Appears in 2 contracts

Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)

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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: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)

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