Large-Scale Process definition

Large-Scale Process means the process operating parameters for the operation of the innoculum and the Fermenter Train used for the production of the Large-Scale Product from the Cell Line and the methods of harvesting and purification of the Large Scale Product.
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Large-Scale Process means the process operating parameters for the operation of the innoculum and the Fermenter Train used for the production of the Large-Scale Product from the Cell Line and the methods of harvesting and purification of the Large Scale Product. *CONFIDENTIAL
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Examples of Large-Scale Process in a sentence

  • LB shall not unreasonably refuse any written request from Alexion to make changes to the Large-Scale Process (for example, changes to the Large-Scale Process which are required by an applicable regulatory authority or applicable laws), but no change to the Large-Scale Process shall be made except by an agreement in writing signed by the authorized representatives of the Parties.

  • The Raw Materials Fee shall be equal to the actual third party costs to LB of the Raw Materials for use in the Large-Scale Process, plus a handling charge of [*****] percent ([*****]%) of such costs.

  • For example, if the Large-Scale Process requires column matrices which can be used for one hundred (100) Batches but which, due to the negligence or willful misconduct of LB, are damaged or destroyed after being used for sixty (60) Batches, LB shall be responsible for forty percent (40%) of the cost of replacing such column matrices as a credit against the Raw Materials Fee.

  • Unless a Party has designated an authorized representative by notice to the Steering Committee, changes to Large-Scale Process or Specifications must be approved in writing by an officer of the Party in question.

  • Alexion shall pay (a) for the avoidance of doubt the Raw Material Fee for all of the Batches actually Delivered, plus (b) the Raw Materials Fee in respect of the following runs of Large-Scale Process which do not result in the delivery of Large-Scale Product: [*****]% of the number of Batches ordered pursuant to a Binding Order in; and [*****]% of the number of Batches ordered pursuant to a Binding Order in the.

  • Without prejudice to LB’s right to receive payment of the Price hereunder or to LB’s own proprietary rights in the Large-Scale Process, the LB Information and the LB Patent Rights, LB agrees that, except as expressly provided in Section 3.2 above, LB shall not by virtue of this Agreement acquire any right, license or title in, or to, the Alexion Patent Rights, the Alexion Information, the Alexion Materials or the Large-Scale Product.

  • LB will invoice Alexion for the Raw Materials Fee in respect to reusable Raw Materials, including but not limited to, which are purchased for use in performing the Large-Scale Process to produce more than one Batch at [*****].

  • LB hereby grants and agrees to grant to Alexion an exclusive, perpetual, royalty-free, worldwide license to utilize the Large-Scale Process for manufacture, use and sale of [*****] (regardless of whether such patent later terminates or expires for any reason).

  • Section 4.2.1 shall be amended to read in its entirety as follows: “Recover ampoules of the cell bank for the Cell Line and expand cultures to complete airlift fermentation at ***** ***** scale in the ***** ***** Manufacturing Suite, using the Large-Scale Process for the Large-Scale Product.

  • Subject to Section 6.3, LB will, in accordance with the terms of this Agreement, manufacture and Deliver to Alexion Batches of Large-Scale Product at [*****] scale in accordance with cGMP using the Large-Scale Process and the Large-Scale Manufacturing Suite.