Reproduction, Rework or Reprocessing. If, during the Production of any Batch of Product, any reprocessing, rework, reproduction, or change is required in order to meet the Product Specifications, or if Celator requests any change with respect to any matter set forth in the Product Master Plan, Baxter shall conduct such reprocessing, rework, or reproduction and implement such change in compliance with cGMP’s. Any reprocessing, rework, reproduction or change, concerning compounding, aseptic filling, or capping must be approved in writing by Celator prior to implementation unless immediate action is required. Celator shall promptly reimburse Baxter for all costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change, except that in the event that any such reprocessing, rework, reproduction, or change results solely from Xxxxxx’x failure to Produce Products according to Product Requirements or Xxxxxx’x negligence or willful misconduct, Baxter shall be responsible for, and promptly reimburse Celator for, **************** in connection with such reprocessing, rework, reproduction, or change.
Appears in 3 contracts
Samples: Clinical and Commercial Manufacturing and Supply Agreement, Clinical and Commercial Manufacturing and Supply Agreement (Celator Pharmaceuticals Inc), Clinical and Commercial Manufacturing and Supply Agreement (Celator Pharmaceuticals Inc)
Reproduction, Rework or Reprocessing. If, during the Production of any Batch of Product, any reprocessing, rework, reproduction, or change is required in order to meet the Product Specifications, or if Celator requests any change with respect to any matter set forth in the Product Master Plan, Baxter shall conduct such reprocessing, rework, or reproduction and implement such change in compliance with cGMP’s. Any reprocessing, rework, reproduction or change, concerning compounding, aseptic filling, or capping must be approved in writing by Celator prior to implementation unless immediate action is required. Celator shall promptly reimburse Baxter for all costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change, except that in the event that any such reprocessing, rework, reproduction, or change results solely from Xxxxxx’x failure to Produce Products according to Product Requirements or Xxxxxx’x negligence or willful misconduct, Baxter shall be responsible for, and promptly reimburse Celator for, [**************** ] in connection with such reprocessing, rework, reproduction, or change.
Appears in 1 contract
Samples: Clinical and Commercial Manufacturing and Supply Agreement (Jazz Pharmaceuticals PLC)