Exhibit Batch definition
Exhibit Batch means the representative manufacturing batches in similar or identical processes to the commercial purpose for submission of regulatory dossier required by authorities.
Exhibit Batch means a full commercial size GMP batch manufactured and tested by Elite to accommodate the CBE-30 filing.
Examples of Exhibit Batch in a sentence
Before provision of the Exhibit Batch, the Parties shall enter into a separate contract specifying terms, including but not limited to the amount to be paid by Aptose to Hanmi for the Exhibit Batch.
Contingent upon the successful completion of the Development, Neos will produce an exhibit batch (each, the “Exhibit Batch”) of the greater of a 1/10 scale of a batch of the Product or 200 liters of the subject Product and place the Exhibit Batch on stability (the “Stability Work”).