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.
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 other Regulatory Authority, and such regulatory changes apply solely to the Production and supply of Product, then AMYLIN and XXXXXX 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 AXXXXX 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 AXXXXX 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 AXXXXX 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 AXXXXX. 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 XXXXXX 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 XXXXXX will review such requirements and agree in writing to such regulatory changes in accordance with the Quality Agreement, and [CONFIDENTIAL TREATMENT REQUESTED] (a) XXXXXX shall assure that all such changes to the Product-specific XXXXXX 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. 9.8
Product-Specific Changes. If facility, equipment, process or system changes are required of XXXXXX 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 XXXXXX 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 by EPIR, and such changes apply primarily to the production and supply of a EPIR Product then EPIR shall allow SETI to review such requirements and changes at least ninety (90) days in advance so that SETI can make any necessary adjustments to its manufacturing processes that include the specific EPIR Product in one or more SETI Products.
Product-Specific Changes. If, after the Effective Date, either party determines that facility, equipment, process or system changes are required as a result of changes in requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of one or more Products, then PRAECIS and XXXXXX jointly will review and discuss such requirements. If the parties agree in writing that such changes are mandated by the change in Regulatory Authority requirements, then PRAECIS shall have the option to: (a) *** of the reasonable costs of those changes that apply primarily to the Production and supply of one or more Products; or (b) terminate this Agreement, in whole, or in part as it relates to the applicable Product, upon *** written notice to XXXXXX.
Product-Specific Changes. If facility, equipment, process or system changes are required of Catalent 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 Client and Catalent will review such requirements and, subject to the Parties’ mutual agreement in writing to such regulatory changes, Client shall bear one hundred percent of the reasonable, documented costs thereof.
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 Xxxxxx as a result of requirements set forth by the FDA or any other 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 such regulatory changes, [***]. XXXXXX & ALDER CONFIDENTIAL 14 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
