Variance

Variance. Is the amount, expressed as a percentage or stated volume, by which the Delivered Volume during a calendar year may vary from the Delivery Plan without * Confidential Treatment Requested 3 either Party being considered in breach of its obligations under this Agreement (without giving consideration to the effects of a Force Majeure Event).

Variance. A departure from an established quality standard (including, without limitation, cGMPs or other standard operating procedures, manufacturing work orders, Packaging orders, raw material or Product Specifications, analytical control procedures, water monitoring procedures, equipment maintenance schedules), whether anticipated or unanticipated, which has the potential to affect the safety, identity, strength, quality or purity of the Product