Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ 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. ▇▇▇▇▇▇ 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
Sources: Drug Product Development and Clinical Supply Agreement (Omeros Corp)
Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ 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. ▇▇▇▇▇▇ shall notify CLIENT of and receive 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
Sources: Manufacturing and Clinical Supply Agreement (Auxilium Pharmaceuticals Inc)
Changes to Master Batch Records and Product Specifications. ▇A▇▇▇▇▇ 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. ▇A▇▇▇▇▇ 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
Sources: Drug Product Development and Clinical Supply Agreement (Omeros Corp)
Changes to Master Batch Records and Product Specifications. ▇A▇▇▇▇▇ 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. ▇A▇▇▇▇▇ shall notify CLIENT of and receive 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
Sources: Drug Product Development and Clinical Supply Agreement (Bio-Path Holdings Inc)
Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ 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. ▇▇▇▇▇▇ 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.of
Appears in 1 contract
Sources: Drug Product Development and Clinical Supply Agreement