Common use of Manufacturing Standards Clause in Contracts

Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product. If at any time during the life of the contract, the Offeror fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.

Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product. If at any time during the life of the this contract, the Offeror fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.

Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product. If at any time during the life of the contract, the Offeror Contractor fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product these products and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror Contractor fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.

Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product. If at any time during the life of the contract, the Offeror Contractor fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror Contractor fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.