Defective Processing. Catalent shall, [**], either (A) if requested or approved by Client, re-Process (or if re-Processing is not permissible under cGMPs, then replace), at its cost any Batch of Defective Product attributable to Catalent Defective Processing (and Client shall be liable to pay for either the rejected Batch (es) or the replacement Batch (es), but not both), or (B) credit any payments made by Client for such rejected Batch. TOE OBLIGATION OF CATALENT TO RE-PROCESS (OR REPLACE) DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT, IN EACH CASE, WHICH IS ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING SHALL BE, TOGETHER WITH CLIENT’S RIGHTS UNDER SECTIONS 13.1 AND 16.2B, CLIENT’S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. In the event of Catalent Defective Processing with respect to [**] or more separate instances in any [**] month period, Client may terminate this Agreement or any Order pursuant to 16.2(B) upon notice to Catalent and without any obligation to provide a further opportunity to cure. For the avoidance of doubt, in the event that in the course of a manufacturing campaign in which more than one Batch is Processed and all of the Batches thereunder are subject to Catalent Defective Processing, such event shall be deemed as a single instance hereunder and not an instance for each Batch in such campaign that may be affected.
Appears in 3 contracts
Sources: Commercial Supply Agreement, Commercial Supply Agreement (Kala Pharmaceuticals, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)