Pilot Batches definition

Pilot Batches means a consistent series of **) Batches at ** w.v., unless the parties otherwise agree on a greater number of Batches.
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Pilot Batches means a Batch of Product designated as a Pilot Batch in the applicable SOW that is not required to comply with cGMP and is not required to meet Specifications.
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Pilot Batches. The price per pilot batch shall be as set forth in Exhibit A.
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Examples of Pilot Batches in a sentence

  • It is understood and acknowledged that the first three (3) Pilot Batches will not meet cGMP or Specification or any specification, quantity or quality obligations and Lonza gives no warranty in this regard.

  • Customer shall pay to Lonza the applicable Price for all Pilot Batches conducted in the Initial Phase (including for the avoidance of doubt, those Pilot Batches before the first three Pilot Batches for which there was no material change in the process or procedure, as well as the first three Pilot Batches for which there was no material change in the process or procedure).

  • In the event that Customer provides written notice of cancellation to Lonza at any time of one or more Pilot Batch(es) [***] or less prior to the Commencement Date for such Pilot Batch, then [***] of the Batch Price of each such Pilot Batch cancelled is payable as a Cancellation Fee.

  • Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such noncompliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

  • Lonza shall manufacture, or procure the manufacture of, the Pilot Batch(es) in accordance with the Project Plan, but shall have no obligation to meet Specification or comply with cGMP in relation to the Pilot Batch(es).

  • Customer shall have the right to make whatever use of the Pilot Batches as it shall determine, provided that Customer pays Lonza the Price for such Pilot Batches, and such use is not for human use and does not violate any Applicable Laws.

  • Customer shall have the right to make whatever use of the Pilot Batch(es) as it shall determine, provided that Customer pays Lonza the Price for such Pilot Batch(es), and such use is not for human use and does not violate any Applicable Laws.

  • Lonza shall manufacture Pilot Batches in accordance with the Project Plan, but shall have no obligation to, and makes no warranty, that Pilot Batches will meet Specification or be manufactured in accordance with cGMP.

  • Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such non compliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

  • Pricing for the Services and the Batches (including, without limitation, Pilot Batches (whether Pilot Drug Substance Batches or Pilot Drug Substance Batches), all Drug Substance Batches and all Drug Product Batches) manufactured by Lonza are set out in, and based on the assumptions and information set out in, the applicable Project Plan.

Related to Pilot Batches

  • 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.