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
Appears in 1 contract
Samples: Drug Product Development and Clinical Supply 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 ofof Drug Product. XXXXXX shall notify CLIENT of and 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: Drug Product 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 ofof Drug Product. AXXXXX shall notify CLIENT of and 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: Drug Product Development and Clinical Supply Agreement (Omeros Corp)
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 ofof 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 1 contract
Samples: Manufacturing and Clinical Supply Agreement (Auxilium Pharmaceuticals Inc)
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 ofof Drug Product. 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: Drug Product Development and Clinical Supply Agreement (Bio-Path Holdings Inc)