Changes to Master Batch Records and Product Specifications. XXXXXX agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. XXXXXX shall notify CLIENT of and require written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.
Appears in 2 contracts
Samples: Supply Agreement (Auxilium Pharmaceuticals Inc), Agreement
Changes to Master Batch Records and Product Specifications. XXXXXX agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. XXXXXX shall notify CLIENT of and require receive written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.
Appears in 1 contract
Samples: Development and Clinical Supply Agreement (Omeros Corp)
Changes to Master Batch Records and Product Specifications. XXXXXX AXXXXX agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. XXXXXX AXXXXX shall notify CLIENT of and require receive written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.
Appears in 1 contract
Samples: Development and Clinical Supply Agreement (Omeros Corp)
Changes to Master Batch Records and Product Specifications. XXXXXX AXXXXX agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. XXXXXX AXXXXX shall notify CLIENT of and require written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.
Appears in 1 contract
Samples: Agreement (Bio-Path Holdings Inc)