Common use of Analytical Methods and Stability Studies Clause in Contracts

Analytical Methods and Stability Studies. Prior to Orion’s first delivery of Product, Orion will provide USL with the relevant analytical test methods information for Product to enable USL to exercise its inspection rights under Section 16.6 below and/or to qualify- as a back-up manufacturer of bulk gel/gel sachets of Product, which test methods shall be deemed Confidential Information of Orion. Orion shall be responsible for conducting, at its expense, all required stability studies for Product (except for studies relating to Product that is not manufactured by Orion). Without limitation, Orion must perform its standard stability test program as committed to in the Product NDA and as defined in Orion’s SOPs, the applicable FDA guidelines and ICH. Orion will provide USL with a copy of its stability reports, as they become available, for each Product. Orion will within, three working (3) days, after a confirmed Out Of Specification (“OOS”) result in the stability testing for a Product, and prior to re-testing for stability, notify USL of those results. In addition, to the extent applicable, Orion will undertake all validation work as may be required by the NDA, CGMP, the Act or other applicable law, Orion’s standard operating procedures, or as otherwise agreed upon by the parties.