Supply of Dental Products; Licenses, Permits Sample Clauses

Supply of Dental Products; Licenses, Permits. Isotis represents and warrants that at the time of execution of this Agreement and at all times during the Term, (A) all Dental Products supplied and manufactured by Isotis for Keystone will, at the time of delivery (i) be supplied and manufactured in accordance and in compliance with the Specifications in all material respects, (ii) not be adulterated or misbranded under the meaning of the FDC Act, (iii) be produced in an FDA-registered manufacturing facility and in a manner which complies with all Applicable Laws and (iv) be supplied with labeling and packaging set forth in the Specifications and (B) it has obtained and maintains all licenses, permits and approvals required by all Governmental Entities and under all Applicable Laws for its manufacturing facilities, including the Facility, and that such facilities conform and will continue to conform to cGMP, ISO 13485-2003 and other applicable quality control standards.