Common use of Validation and Testing Clause in Contracts

Validation and Testing. Vertical and Mikart acknowledge that Mikart must validate three (3) Batches of each strength of the Product prior to selling any of the Product to Vertical (the “Validation”). After Mikart successfully completes the Validation, Vertical shall be obligated to purchase the Batches so validated in accordance with the terms of this Agreement. Such Batches shall be part of, and shall be applied to, Vertical’s minimum purchase requirements within the first Contract Year. Mikart shall conduct stability testing on the Product as required by federal law (the “Stability Testing”). Mikart shall maintain Stability Testing and Validation data at its Atlanta, Georgia facilities or at such other location as agreed to by Vertical and Mikart in accordance with FDA regulations. All of Mikart’s costs incurred in connection with the Validation, the Stability Testing and the storage of data related thereto shall be periodically billed to and paid by Vertical. Mikart shall maintain the ANDA in full force and effect at all times during the Term of this Agreement.