Common use of FDA Regulation Clause in Contracts

FDA Regulation. (a) Since January 1, 2003, the ▇▇▇▇▇▇ Entities have been in compliance in all material respects with all applicable provisions of the Federal Food, Drug and Cosmetic Act 21 U.S.C. 301 et seq. (“FFDCA”), the Public Health Service Act and all applicable implementing U.S. Food and Drug Administration (“FDA”) rules, regulations and policies, and all corresponding applicable foreign, state and local laws, rules and regulations relative to the conduct or operation of the ▇▇▇▇▇▇ Business, the products manufactured or sold by any of the ▇▇▇▇▇▇ Entities (the “Products”) or the ownership or use of any of their assets or properties (including, without limitation, the good manufacturing practice requirements under the Quality System Regulation, 21 C.F.R. 820, and the electronic records and the electronic signatures regulation at C.F.R. Part 11). Since January 1, 2003, none of the Products is or has been adulterated or misbranded as defined under FFDCA. Since January 1, 2003, no ▇▇▇▇▇▇ Entity has received any written notification from the FDA or any other applicable governmental authority indicating that any of the Products is misbranded or adulterated. Since January 1, 2003, none of the employees, agents or independent contractors of the ▇▇▇▇▇▇ Entities has been disbarred, subject to disbarment under 21 U.S.C. 335, or otherwise disqualified or suspended from performing services or otherwise subject to any restrictions or sanctions by the FDA or any other governmental authority or professional body.

FDA Regulation. (a) Since January 1, 2003, the ▇▇▇▇▇▇ Kendro Entities have been in compliance in all material respects resp▇▇▇▇ with all applicable provisions of the Federal Food, Drug and Cosmetic Act 21 U.S.C. 301 et seq. (“"FFDCA”"), the Public Health Service Act and all applicable implementing U.S. Food and Drug Administration (“"FDA”") rules, regulations and policies, and all corresponding applicable foreign, state and local laws, rules and regulations relative to the conduct or operation of the ▇▇▇▇▇▇ Kendro Business, the products manufactured or sold by any of the ▇▇▇▇▇▇ o Entities (the “"Products”") or the ownership or use of any of their ▇▇▇▇▇ assets or properties (including, without limitation, the good manufacturing practice requirements under the Quality System Regulation, 21 C.F.R. 820, and the electronic records and the electronic signatures regulation at C.F.R. Part 11). Since January 1, 2003, none of the Products is or has been adulterated or misbranded as defined under FFDCA. Since January 1, 2003, no ▇▇▇▇▇▇ Kendro Entity has received any written notification from the FDA or any other ▇▇▇ ▇ther applicable governmental authority indicating that any of the Products is misbranded or adulterated. Since January 1, 2003, none of the employees, agents or independent contractors of the ▇▇▇▇▇▇ Kendro Entities has been disbarred, subject to disbarment under 21 U.S.C. 2▇ ▇.▇.C. 335, or otherwise disqualified or suspended from performing services or otherwise subject to any restrictions or sanctions by the FDA or any other governmental authority or professional body.