definiens: shall mean any Excip ient that does not meet the pre - approved release Specifications at the time of release and includes materials as to which any of the following apply : a ) the materials have not been packaged for shipment in ac cordance with the instructions agreed to in writing by Company and [COMPANY] ; b ) the materials do not meet Spec ification upon delivery to the carrier approved by Company ; c ) the materials shipped do not have an ac curate Certificate of Compliance and/or Certificate of Analysis d ) the materials were not manufactured in accord with cGMP, the Batch Record, the Specificati ons and the Quality Agreement or e ) contains a Latent Defec t. For the avoidance of doubt Nonconforming Excipie nt can not be as a result of any action or inaction tha t occurs following delivery of Excipient or Raw Mat erials to Company