Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Agreement, Applicable Law, and in accordance with any other validation procedures established by Rhythm and made known in writing to Manufacturer. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
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.)
Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable)cGMP, Manufacturer’s internal SOPs, the applicable Quality Agreement, Applicable Law, and in accordance with any other reasonable validation procedures established by Rhythm RADIUS and made known in writing to Manufacturer. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
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.)
Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality AgreementAgreement (if any), Applicable Law, and in accordance with any other validation procedures established by Rhythm and made known in writing to Manufacturer. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
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.)
Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable)cGMP, Manufacturer’s SOPs, the applicable Quality Agreement, Applicable Law, and in accordance with any other validation procedures established by Rhythm and made known in writing to ManufacturerManufacturer or their designated third party. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
Appears in 2 contracts
Samples: Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.)
Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Agreement, and Applicable Law, and in accordance with any other validation procedures established by Rhythm and made known in writing to Manufacturer. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Emergent BioSolutions Inc.)
Validation. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable)cGMP, Manufacturer’s 's SOPs, the applicable Quality Agreement, Applicable Law, and in accordance with any other validation procedures established by Rhythm and made known in writing to ManufacturerManufacturer or their designated third party. Manufacturer will also be responsible for ensuring that all such validated processes are carried out in accordance with their terms.
Appears in 1 contract
Samples: Supply Agreement (CorMedix Inc.)