VALIDATION RUNS definition
VALIDATION RUNS. Promptly after completion of the Equipment validation as provided in Section 3.3 above, ▇▇▇▇▇▇ shall conduct validation runs of the Equipment and separately of the fill process (which uses ▇▇▇▇▇▇ equipment), in accordance with the jointly agreed upon protocols for such validation runs. Each such validation run shall use appropriate [***]. Altus shall determine whether each such validation Batch manufactured by ▇▇▇▇▇▇ and delivered to Altus has met the success criteria for the validation run, which criteria shall be as established by Altus in agreement with ▇▇▇▇▇▇, such agreement not to be unreasonably withheld. If a particular validation run conducted by ▇▇▇▇▇▇ fails to meet such criteria, an appropriate representative from each Party shall meet and discuss and seek to determine the causes of such validation run having failed to meet such criteria, and ▇▇▇▇▇▇ shall use best efforts to rectify any such problems as soon as practicable. ▇▇▇▇▇▇ shall recommence conducting the applicable validation run, and shall conduct such validation runs (on each of the Equipment and the fill process, until three (3) consecutive validation runs for each the particular manufacturing steps (i.e., using the Equipment or using fill equipment) have met the applicable criteria.
VALIDATION RUNS means [**] consecutive production batches of Bulk Drug Substance that are manufactured by Abbott, or on behalf of or for Abbott, pursuant to and in accordance with the requirements set forth in Exhibit C.