Common use of Reprocess and Batch Adjustments Clause in Contracts

Reprocess and Batch Adjustments. Rework/Retest 8.01 Have procedures for batch adjustments and reprocessing, if applicable. Reprocessing is defined as introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g. distillation, filtration, chromatography. and milling) that are part of the manufacturing process. X 8.02 Will not blend Out of Specification batches with other batches for the purpose of meeting specifications. X 8.03 Have a protocol for Product requiring rework describing the rationale and justification for rework for approved filed rework processes, if applicable. Rework is defined as subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain an acceptable quality intermediate or API (e.g. recrystallizing with a different solvent). X 8.04 Receive written approval by Client for rework outside of approved filed rework processes. X 8.05 Will not perform recovery of materials and/or solvents unless approved procedures and specifications are in place. X

Reprocess and Batch Adjustments. Rework/Retest 8.01 12.01 Have procedures for batch adjustments and reprocessing, if applicable. Reprocessing is defined as introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g. distillation, filtration, chromatography. , and milling) that are part of the manufacturing process. X✔ 8.02 12.02 Will not blend Out of Specification batches with other batches for the purpose of meeting specifications. X✔ 8.03 12.03 Have a protocol for Product requiring rework describing the rationale and justification for rework for approved filed rework processes, if applicable. Rework is defined as subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain an acceptable quality intermediate or API (e.g. recrystallizing with a different solvent). X✔ 8.04 12.04 Receive written approval by Client for rework outside of approved filed rework processes. X✔ 8.05 12.05 Will not perform recovery of materials and/or solvents unless approved procedures and specifications are in place. X✔