Product-Specific Changes. If Facility, equipment, process or system changes are required of Xxxxxx as a result of requirements set forth by the FDA or any Regulation, and such regulatory changes apply only to the Production and supply of one or more Client Products, then Client and Xxxxxx will review such requirements and agree in writing to the changes, and Client shall bear the reasonable costs thereof.
Appears in 3 contracts
Samples: Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc)
Product-Specific Changes. If Facilityfacility, equipment, process or system changes are required of Xxxxxx as a result of requirements set forth by the FDA or any Regulationa Regulatory Authority, and such regulatory changes apply only solely to the Production and supply of one or more Client Products, then Client and Xxxxxx will review such requirements and agree in writing to the such regulatory changes, and Client shall bear [* * *] percent ([* * *]%) of the reasonable costs thereof.
Appears in 2 contracts
Samples: Product Development and Clinical Supply Agreement, Product Development and Clinical Supply Agreement (Genocea Biosciences, Inc.)
Product-Specific Changes. If Facility, equipment, process or system changes are required of Xxxxxx required, for example, as a result of requirements set forth by the FDA or in any Regulationother Regulations, and such regulatory required changes apply only to the Production and supply of one or more Client Products, then Client and Xxxxxx will review such requirements and agree in writing to the changes, and Client shall bear the reasonable costs thereof.
Appears in 2 contracts
Samples: Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (Revance Therapeutics, Inc.), Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (Revance Therapeutics, Inc.)
Product-Specific Changes. If Facility, equipment, process or system changes are required of Xxxxxx as a result of requirements set forth by the FDA or in any Regulationother Regulations, and such regulatory required changes apply only to the Production and supply of one or more Client Products, then Client and Xxxxxx will review such requirements and agree in writing to the changes, and Client shall bear the reasonable costs thereof.
Appears in 1 contract
Samples: Commercial Fill/Finish Services Agreement (INSMED Inc)
Product-Specific Changes. If Facilityfacility, equipment, process or system changes are required of Xxxxxx as a result of requirements set forth by the FDA or any Regulationother Regulatory Authority, and such regulatory changes apply only to the Production and supply of one or more Client Products, then Client and Xxxxxx will review such requirements and agree in writing to the such regulatory changes, and Client shall bear the reasonable costs thereof[***].
Appears in 1 contract
Samples: Master Product Development and Clinical Supply Agreement (Alder Biopharmaceuticals Inc)