Batch Run definition

Batch Run means the production and purification process performed by ImmunoGen to generate a Batch of Drug Substance pursuant to this Agreement.
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Examples of Batch Run in a sentence

  • The Parties acknowledge that these Draft Specifications are subject to change with the collection of Batch Run manufacturing data.

  • BI Pharma shall deliver the necessary quantities of BIWA4, at BI Pharma's sole cost, for a Batch Run no less than [ * ] days prior to the scheduled initiation of the Batch Run.

  • Cost Per Batch Run 500 liters = US$6,000 5,000 liters = US$12,500 50,000 liters = US$25,000 The cost per batch run includes all inoculation, seeding, sterilization, cleaning, sampling and process control needed to produce the Fermentation Product.

  • Auxilium’s right to exercise the BLA Batch Option shall expire on the earlier of (a) the date the BLA Batch Run 1 or any new BLA Batch Run achieves final QA release, or (b) December 31, 2007.

  • ImmunoGen shall issue a written request for BIWA4 to BI Pharma (a “Shipment Order”) including, but not limited to, amount and delivery date not later than [ * ] prior to the scheduled initiation of the Batch Run.

  • COBRA agrees that in no event shall the total costs for each BLA Batch Run exceed [***********].

  • Auxilium shall not unreasonably refuse QA release of BLA Batch Run 1 or any replacement BLA Batch Run.

  • If there exists six (6) months worth of existing data for the added Critical Application or Critical Batch Run, then the MSL is established per Section 6.0.a.1. above.

  • In the event that Auxilium exercises the BLA Batch Option, Auxilium shall provide written or electronic (email) notice to Cobra, and Cobra shall have ninety (90) days from the date it receives such notice to complete a new BLA Batch Run that achieves final QA release as a replacement for BLA Batch Run 1.

  • ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the [ * ] or [ * ] of ImmunoGen.

Related to Batch Run

  • Batch Record means the production record pertaining to a Batch.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.