Common use of Product-Specific Changes Clause in Contracts

Product-Specific Changes. For the initial Production of Company Plasmid DNA under this Agreement, no facility, equipment, process or system changes that are required of A▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority shall affect time line and price. For any subsequent Production, if facility, equipment, process or system changes that are required of A▇▇▇▇▇ as a result of requirements set forth by the FDA or any Regulatory Authority, any such regulatory changes which apply solely to the Production and supply of one or more Company Plasmid DNAs, then CLIENT and A▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes, and agree on additional cost to CLIENT. If an agreement as to the additional cost to CLIENT is not reached then this agreement may be terminated by either Party. In case of termination in accordance with this section CLIENT will be entitled to a refund of all moneys paid to A▇▇▇▇▇. It is agreed that termination under this section is not subject to section 3.3.