All Products supplied to AYTU by TRIS under this Agreement will meet the Product Specifications as of the date that title to such Product is delivered to AYTU and TRIS shall continue to use Commercially Reasonable Efforts to rectify any deficiencies identified in the FDA Letter.

Except as otherwise provided in this Agreement, TRIS shall use Commercially Reasonable Efforts to obtain and maintain all necessary licenses, permits and approvals required by the FDA and other Governmental Authorities in the United States in connection the manufacture of the Products. TRIS shall promptly notify AYTU of any adverse regulatory action related to the Product of which it becomes aware. TRIS has provided AYTU with a complete and correct copy of the FDA Letter through the following link: