Product-Specific Changes Clause Samples

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply solely to the Production and supply of Product, then AMYLIN and ▇▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes, and AMYLIN shall bear [***]% of the reasonable costs thereof.

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.

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of a Product, then CLIENT and ▇▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes in accordance with the Quality Agreement, and CLIENT shall bear [CONFIDENTIAL TREATMENT REQUESTED] of the reasonable costs thereof; provided, however, that (a) ▇▇▇▇▇▇ shall assure that all such changes to the Product-specific ▇▇▇▇▇▇ SOPs are consistent with the Product Master Plan unless the parties otherwise expressly agree in writing, and (b) any changes to the Product Master Plan shall be made only in accordance with Section 2.2.

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of new requirements that FDA or any other Regulatory Authority promulgates after initiation of the Project Plan, and such regulatory changes apply primarily to the Production and supply of one or more Drug Products, then CLIENT and ▇▇▇▇▇▇ will review such requirements and agree in writing to such facility, equipment, process or system changes, and CLIENT shall bear 100% of the reasonable costs thereof. In the event that CLIENT chooses not to bear the costs of such changes, then CLIENT may cancel any uninitiated Production of Drug Product without incurring any Cancellation Fees or other penalties hereunder.

Product-Specific Changes. If Facility, equipment, process or system changes are required of Novasep as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply only to the Manufacture and supply solely to the Product, then Tetraphase and Novasep will review such requirements and agree in writing to such regulatory changes, and Tetraphase shall bear [**]% of the reasonable costs thereof.

Product-Specific Changes. If facility, equipment, process or system changes are required of Baxter as a result of requirements set forth by a Regulatory Authority, and such regulatory changes apply solely to the Production and supply of one or more Products, then Client and Baxter will review such requirements and agree in writing to such regulatory changes, and Client shall bear one hundred percent (100%) of the reasonable costs thereof.

Product-Specific Changes. If facility, equipment, process, system or specification changes are required of ▇▇▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply solely to the Manufacturing and supply of the Contracted Products, the Parties shall review such requirements and agree in writing to such regulatory changes, including reasonable costs thereof. Unless otherwise mutually agreed to in writing, ▇▇▇▇▇▇▇ shall bear [****] of the costs (i) [****]. In the event any facility, equipment, process, system or specification changes are required of ▇▇▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply both to the Manufacturing and supply of the Contracted Products and the products of other ▇▇▇▇▇▇▇▇ customers, the Parties agree to negotiate in good faith a reasonable allocation of the costs (if any) associated with such changes. If the Parties cannot agree on how to allocate the costs of any other changes, this matter shall be referred to the Expert or Expert Panel pursuant to Section 22, and the Expert or Expert Panel shall finally determine the allocation of costs. For clarity, ▇▇▇▇▇▇▇▇ is under no obligation to implement any changes unless there is agreement between the Parties regarding the costs.

Product-Specific Changes. If facility, equipment, process or system changes are required of Ology Bio as a result of requirements set forth by a Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of one or more Client Products, then Client and Ology Bio will review such requirements and agree in writing to such regulatory changes, and Client shall bear one hundred percent (100%) of the reasonable costs thereof.

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply solely to the Production and supply of one or more Products, then Dynavax