Engineering Batch means a Batch that is intended to demonstrate the transfer of the Process to the Facility.

Engineering Batch means a Batch produced from an Engineering Run.

Engineering Batch means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. After Manufacture, Client shall have the right to make whatever further use of non-cGMP Engineering Batches as it shall determine, provided that Client pays for such Batches according to this MSA, such use is not for human use and does not violate any Applicable Laws. SBL makes no warranty that Engineering Batches will meet cGMP or the Specifications. If SBL determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch, and thereafter Client shall be entitled to use such Engineering Batch for human use.

Examples of Engineering Batch in a sentence

If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch.
If the Engineering Batch was not performed in accordance with mutually agreed plans or does not meet the agreed bioburden specification, then Lonza shall bear the costs of replacing the Batch, the Raw Materials and Customer Materials for any replacement Engineering Batch.
Regardless of whether any Engineering Batch meets cGMP or the Specifications, Customer shall pay to Lonza the Price for such Engineering Batch that were executed in accordance with mutually agreed plans and meet a mutually agreed specification for bioburden, plus the Raw Materials Fee associated with such Engineering Batches.
Regardless of whether any Engineering Batch meets cGMP or the Specifications, Forty Seven shall pay to Lonza the Price for such Engineering Batch plus the Raw Materials Fee associated with such Engineering Batches.
Lonza shall issue invoices to Forty Seven for [*] of the Price for each Engineering Batch and each Additional cGMP Batch upon commencement thereof and [*] upon Release of each such applicable Batch, unless otherwise stated in the Project Plan.

More Definitions of Engineering Batch

Engineering Batch means the first Batch at scale after the pilot Batch in which Lonza will use commercially reasonable efforts but does not warrant to meet cGMP;

Engineering Batch means one (1) test batch or lot, as applicable, of product manufactured at scale in accordance with its applicable Specifications, excluding completion of all release test results.

Engineering Batch means a test Batch manufactured in a CGMP-qualified manufacturing suite at the same scale and with a Manufacturing Process similar to the intended CGMP Manufacturing Process of an intended CGMP Batch, but not subject to CGMP and without any obligation to meet any Specifications.

Engineering Batch means a commercial-scale Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. After Manufacture, Client shall have the right to make whatever further use of non-cGMP Engineering Batches as it shall determine, provided that Client pays for such Batches according to this MSA, and such use is not for human use and does not violate any Applicable Laws. SBL makes no warranty that Engineering Batches will meet cGMP or the Specifications.

Engineering Batch means a Batch produced from an Engineering Run, and which may be used by Sponsor for Sponsor’s toxicology studies or otherwise in accordance with this Agreement.

Engineering Batch means: the Product obtained from one production run at scale under GMP conditions using the Draft Procedures and Draft GMP Specification and final process as agreed after the Process Development Phase, which Product will be tested to see if the Process Development Objectives can be met at large scale, which Product is not intended for use in Clinical Studies.

Engineering Batch a Batch that is manufactured in a cGMP Facility at scale using the Process but which is not intended for human use and is identified as such in the applicable SoW;