Stability Testing and Validation Sample Clauses
Stability Testing and Validation. Unigene must perform its standard stability test program as committed to in the NDA for Vials and as defined in Unigene's SOPs and the applicable FDA guidelines. Unigene will provide USL with a copy of its stability report, as it becomes available, for any Product. Unigene will, within ** (**) Business Days, after an Out Of Specification ("OOS") result in the stability testing for any Product, and prior to re-testing for stability, notify USL of those results.
Stability Testing and Validation. Eon must perform its standard stability test program as committed to in the ANDA for the Product and as defined in Eon's SOPs, the applicable FDA guidelines. Eon will provide ▇▇▇▇▇▇-▇▇▇▇▇ with a copy of its stability report, as it becomes available, for each Product. Eon will within, three (3) business days, after an Out Of Specification ("OOS") result in the stability testing for a Product, and prior to re-testing for stability, notify ▇▇▇▇▇▇-▇▇▇▇▇ of those results.