Common use of Manufacturing Standards Clause in Contracts

Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the Government Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract may be terminated.

Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part GMP)(21 CFR Parts 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contractcontract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the Government Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract contract may be terminated.

Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part GMP)(21 CFR Parts 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contractcontract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the Government USG Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract contract may be terminated.

Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part 820GMP)(21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contractcontract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) [**] calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) [**] calendar day period, the Contractor fails to take such an action to the satisfaction of the Government USG Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract contract may be terminated.

Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part CFR Parts 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contractcontract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the Government Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract contract may be terminated.