Testing by Manufacturer. The Product Manufactured under this Agreement will be Manufactured in accordance with the Manufacturing Process approved by Rhythm, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the Specifications. Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Appears in 8 contracts
Samples: Development and Manufacturing Services Agreement, Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.), Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)
Testing by Manufacturer. The Product to be Manufactured under this Agreement will be Manufactured in accordance with cGMP, unless otherwise stated in the Work Order, and the Manufacturing Process approved by Rhythm, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the SpecificationsRADIUS. Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Appears in 4 contracts
Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)
Testing by Manufacturer. The Product Manufactured under this Agreement will be Manufactured in accordance with the Manufacturing Process approved by Rhythm, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the Specifications). Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Appears in 3 contracts
Samples: Development and Manufacturing Services Agreement, Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.), Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)
Testing by Manufacturer. The Product to be Manufactured under this Agreement will be Manufactured in accordance with cGMP, unless otherwise stated in the Work Order, and the Manufacturing Process approved by Rhythm, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the SpecificationsAnterios. Each Batch of Product will be sampled and tested by Manufacturer against in accordance with the Specifications, Specifications and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing ProcessQuality Agreement.
Appears in 3 contracts
Samples: Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc)
Testing by Manufacturer. The Product Manufactured to be supplied under this Agreement will be Manufactured in accordance with cGMP, unless otherwise stated in the Work Order, and the Manufacturing Process approved by Rhythm, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the SpecificationsCustomer. Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Appears in 3 contracts
Samples: Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.)
Testing by Manufacturer. The Product Manufactured under this Agreement will be Manufactured in accordance with the Manufacturing Process approved by RhythmAlnylam, the Specifications and with cGMP (unless otherwise expressly stated in the applicable Work Purchase Order) and will conform to the Specifications). Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) ), the Specifications and the Manufacturing Process.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Alnylam Pharmaceuticals, Inc.)
Testing by Manufacturer. The Product Manufactured under this Agreement will be Manufactured in accordance with the Manufacturing Process approved by RhythmTectonic, and with cGMP (unless otherwise expressly stated in the applicable Work Order) and will conform to the Specifications). Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (AVROBIO, Inc.)