Facility Maintenance; Inspection; Reports. Duramed shall, at all times, maintain and operate all facilities where Shire Products are manufactured, packaged or tested, and implement required quality control procedures to perform its obligations under this Agreement. Not more than once every twelve (12) months (or more often in the case of a deficiency), Duramed shall permit, or cause its contractors to permit, quality assurance representatives of Shire or designated third parties and representatives of the applicable Government Authority to inspect such facilities upon reasonable advance notice, during normal business hours and on a confidential basis. Duramed shall promptly provide, or cause its contractor to provide, Shire with a copy of any notice from the applicable Government Authority received at the conclusion of an inspection relating to any Shire Product.
Appears in 2 contracts
Samples: Product Development and License Agreement (Barr Pharmaceuticals Inc), Product Development and License Agreement (Shire PLC)
Facility Maintenance; Inspection; Reports. Duramed Shire shall, at all times, maintain and operate all facilities where Shire Products are manufactured, packaged or tested, and implement required quality control procedures to perform its obligations under this Agreement. Not more than once every twelve (12) months [*] (or more often in the case of a deficiency), Duramed Shire shall permit, or cause its contractors to permit, quality assurance representatives of Shire Duramed or designated third parties and representatives of the applicable Government Authority to inspect such facilities upon reasonable advance notice, during normal business hours and on a confidential basis. Duramed Shire shall promptly provide, or cause its contractor to provide, Shire Duramed with a copy of any notice from the applicable Government Authority received at the conclusion of an inspection relating to any Shire Product.
Appears in 2 contracts
Samples: Product Acquisition and License Agreement (Barr Pharmaceuticals Inc), Product Acquisition and License Agreement (Shire PLC)