Gallus Failure

Gallus Failure. Means a Defective Batch caused by Gallus's negligence or willful misconduct. For purposes of this Section 1(u), Gallus's "negligence" will include Gallus's material failure to (i) follow agreed upon procedures, or (ii) adequately maintain or calibrate equipment or (iii) failure to comply in all material respects with cGMP applicable to the Services or Drug Product or Drug Substance. For the avoidance of doubt, a Gallus Failure shall not include a Defective Batch from any other cause, including... any issue that is inherent to the Product or Process. View More