Exhibit Batches definition
Exhibit Batches means the manufacturing batches of Licensed Product required by FDA in order to file an ANDA for such Licensed Product.
Exhibit Batches means means a batch for use in obtaining registration of the Product shall be of a size that is at least one-tenth (1/10th) of the commercial Batch size. This batch may be used in conducting bioequivalence studies, as necessary.
Examples of Exhibit Batches in a sentence
LICENSOR and LICENSEE shall share equally all prosecution and maintenance expenses; provided, however, that in the event that LICENSEE funds the development of the Exhibit Batches for any Licensed Product, LICENSEE shall pay [***] percent ([***]%) of such costs incurred after the date of ANDA filing for such Licensed Product and LICENSOR shall pay [***] percent ([***]%) of such costs.