Examples of Catalent Defective Processing in a sentence
Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by Catalent if Product is Defective Product attributable to Catalent Defective Processing, and by Client in all other circumstances.
For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing.
If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, and this is not resolved within 30 days of the Exception Notice date, the parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Product and its components, including Client-supplied Materials.
For the avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall not be deemed Catalent Defective Processing or Catalent Defective Packaging.
Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by Catalent if Product is Defective Product attributable to Catalent Defective Processing, and by Palatin in all other circumstances.
This shall be Palatin’s sole and exclusive remedy under this Agreement for Defective Product attributable to Catalent Defective Processing, other than as provided in Clause 4.7, 9.5 and 13.1 of this Agreement.
Catalent shall, at its option, either (A) 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.
During the treatment period, subjects will return to the clinic at the end of 2 and 4 weeks for clinical evaluation and thereafter will return to the clinic once every 4 weeks during the treatment period322for scheduled visits.
Catalent will, at its option, either replace or repackage any Defective Product attributable to Catalent Defective Processing or Catalent Defective Packaging or credit any payments made by Client for such Batch.
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.