Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Material Adverse Effect, Trooper is, and since December 31, 2011, has been, in compliance with all Healthcare Laws applicable to Trooper and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Trooper is being, and has been since December 31, 2011, conducted in material compliance with all applicable Healthcare Laws, including, without limitation, requirements relating to clinical and non-clinical research, product approval or clearance, premarketing notification, labeling, advertising and promotion, record-keeping, adverse event reporting, reporting of corrections and removals, and current good manufacturing practices for medical device products. Trooper and, to Trooper’s knowledge, any contract manufacturers assisting in the manufacture of the Products or Product components are, and, since December 31, 2011, have been, in compliance with FDA’s device registration and listing requirements to the extent required by applicable Healthcare Laws insofar as they pertain to the manufacture of Products or Product components for Trooper, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Material Adverse Effect. Trooper has not received written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body, including, without limitation, the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services Office of Inspector General or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Trooper under any Healthcare Law.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Visor Material Adverse Effect, Trooper Visor is, and since December March 31, 20112012, has been, in compliance with all Healthcare Laws applicable to Trooper Visor and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Visor Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Trooper Visor is being, and has been since December March 31, 20112012, conducted in material compliance with all applicable Healthcare Laws, including, without limitation, requirements relating to clinical and non-clinical research, product approval or clearance, premarketing notification, labeling, advertising and promotion, record-keeping, adverse event reporting, reporting of corrections and removals, and current good manufacturing practices for medical device products. Trooper Visor and, to TrooperVisor’s knowledgeKnowledge, any contract manufacturers assisting in the manufacture of the Products or Product components are, and, since December March 31, 20112012, have been, in compliance with FDA’s device registration and listing requirements to the extent required by applicable Healthcare Laws insofar as they pertain to the manufacture of Products or Product components for TrooperVisor, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Visor Material Adverse Effect. Trooper Visor has not received written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body, including, without limitation, the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services Office of Inspector General or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Trooper Visor under any Healthcare Law.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Union Material Adverse Effect, Trooper Union is, and since December March 31, 20112012, has been, in compliance with all Healthcare Laws applicable to Trooper Union and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Union Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Trooper Union is being, and has been since December March 31, 20112012, conducted in material compliance with all applicable Healthcare Laws, including, without limitation, requirements relating to clinical and non-clinical research, product approval or clearance, premarketing notification, labeling, advertising and promotion, record-keeping, adverse event reporting, reporting of corrections and removals, and current good manufacturing practices for medical device products. Trooper Union and, to TrooperUnion’s knowledgeKnowledge, any contract manufacturers assisting in the manufacture of the Products or Product components are, and, since December March 31, 20112012, have been, in compliance with FDA’s device registration and listing requirements to the extent required by applicable Healthcare Laws insofar as they pertain to the manufacture of Products or Product components for TrooperUnion, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Union Material Adverse Effect. Trooper Union has not received written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body, including, without limitation, the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services Office of Inspector General General, or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Trooper Union under any Healthcare Law.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Ranger Material Adverse Effect, Trooper Ranger is, and since December 31, 2011, has been, in compliance with all Healthcare Laws applicable to Trooper Ranger and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Ranger Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Trooper Ranger is being, and has been since December 31, 2011, conducted in material compliance with all applicable Healthcare Laws, including, without limitation, requirements relating to clinical and non-clinical research, product approval or clearance, premarketing notification, labeling, advertising and promotion, record-keeping, adverse event reporting, reporting of corrections and removals, and current good manufacturing practices for medical device products. Trooper Ranger and, to TrooperRanger’s knowledge, any contract manufacturers assisting in the manufacture of the Products or Product components are, and, since December 31, 2011, have been, in compliance with FDA’s device registration and listing requirements to the extent required by applicable Healthcare Laws insofar as they pertain to the manufacture of Products or Product components for TrooperRanger, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Trooper Ranger Material Adverse Effect. Trooper Ranger has not received written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body, including, without limitation, the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services Office of Inspector General General, or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Trooper Ranger under any Healthcare Law.