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 Ranger Material Adverse Effect, Ranger is, and since December 31, 2011, has been, in compliance with all Healthcare Laws applicable to Ranger and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of 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. Ranger and, to Ranger’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 Ranger, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Material Adverse Effect. 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, or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Ranger under any Healthcare Law. (b) Ranger holds such Permits of Governmental Bodies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Ranger Licenses”), except to the extent where the failure to hold such Permits would not, individually or in the aggregate, be reasonably expected to have a Ranger Material Adverse Effect. Ranger has fulfilled and performed all of its obligations with respect to each Ranger License and is in material compliance with all terms and conditions of each Ranger License, and, to Ranger’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, suspension or termination thereof or would result in any other impairment of the rights of the holder of any Ranger License, except to the extent where the failure to be in material compliance would not, individually or in the aggregate, be reasonably expected to have a Ranger Material Adverse Effect. Ranger has not received any written information or notification from the FDA or any other Governmental Body with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, distribution or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Body. (c) All material filings, reports, documents, claims, submissions and notices required to be filed, maintained or furnished to the FDA, state or other Governmental Bodies have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports, medical device reports and reports of corrections and removals with regard to the Products. All applications, notifications, submissions, information, claims, reports, filings and other data and conclusions derived therefrom utilized as the basis for, or submitted in connection with, any and all requests for a Ranger License from the FDA or other Governmental Body relating to Ranger or its businesses or the Products, when submitted to the FDA or any other Governmental Body, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to the FDA or other Governmental Body and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects and do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading. (d) Ranger has not received any written notice or other communication from the FDA or any other Governmental Body contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products or Product components (whether Ranger-owned or operated or that of a contract manufacturer for any Products or Product components) has been subject to a Governmental Body (including the FDA) shutdown or import or export detention, refusal or prohibition. Neither Ranger nor, to Ranger’s knowledge, any manufacturing site which assists in the manufacture of any material Products or material Product components (whether Ranger-owned or operated or that of a contract manufacturer for the Products or Product components) has received, since December 31, 2011, any FDA Form 483 or other Governmental Body notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Ranger Licenses or alleging a lack of safety or effectiveness from the FDA or any other Governmental Body, and, to Ranger’s knowledge, there is no such action or proceeding pending or threatened. (e) The FDA has not mandated that Ranger recall any of its Products. There are no recalls of any of Ranger’s Products contemplated by Ranger or pending. Since December 31, 2011, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product component, or seizures ordered or adverse regulatory actions taken (or, to Ranger’s knowledge, threatened) by the FDA or any Governmental Body with respect to any of the Products or Product components or any facilities where Products or Product components are developed, designed, tested, manufactured, assembled, processed, packaged or stored. (f) Except as set forth on Schedule 3.20(f) of the Ranger Disclosure Letter, there are no clinical trials that are being conducted as of the date hereof by or on behalf of, or sponsored by, Ranger. (g) Ranger is not the subject of any pending or, to the knowledge of Ranger, threatened investigation regarding Ranger or the Products by the FDA pursuant to the FDA Fraud Policy. Neither Ranger nor, to the knowledge of Ranger, any officer, employee, agent or distributor of Ranger has made an untrue statement of material fact to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Body to invoke the FDA Fraud Policy or any similar policy. Neither Ranger nor, to the knowledge of Ranger, any officer, employee, agent or distributor of Ranger has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a debarment or exclusion are pending or, to the knowledge of Ranger, threatened, against Ranger or, to the knowledge of Ranger, any of its directors, officers, employees or agents.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Trooper Material Adverse Effect, Ranger Trooper is, and since December 31, 2011, has been, in compliance with all Healthcare Laws applicable to Ranger Trooper and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Trooper Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Ranger 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. Ranger Trooper and, to RangerTrooper’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 RangerTrooper, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Trooper Material Adverse Effect. Ranger 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, General or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Ranger Trooper under any Healthcare Law. (b) Ranger Trooper holds such Permits of Governmental Bodies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Ranger Trooper Licenses”), except to the extent where the failure to hold such Permits would not, individually or in the aggregate, be reasonably expected to have a Ranger Trooper Material Adverse Effect. Ranger Trooper has fulfilled and performed all of its obligations with respect to each Ranger Trooper License and is in material compliance with all terms and conditions of each Ranger Trooper License, and, to RangerTrooper’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, suspension or termination thereof or would result in any other impairment of the rights of the holder of any Ranger Trooper License, except to the extent where the failure to be in material compliance would not, individually or in the aggregate, be reasonably expected to have a Ranger Trooper Material Adverse Effect. Ranger Trooper has not received any written information or notification from the FDA or any other Governmental Body with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, distribution or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Body. (c) All material filings, reports, documents, claims, submissions and notices required to be filed, maintained or furnished to the FDA, state or other Governmental Bodies have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports, medical device reports and reports of corrections and removals with regard to the Products. All applications, notifications, submissions, information, claims, reports, filings and other data and conclusions derived therefrom utilized as the basis for, for or submitted in connection with, with any and all requests for a Ranger Trooper License from the FDA or other Governmental Body relating to Ranger Trooper or its businesses or the Products, when submitted to the FDA or any other Governmental Body, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to the FDA or other Governmental Body and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects respects, and do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading. (d) Ranger Trooper has not received any written notice or other communication from the FDA or any other Governmental Body contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products or Product components (whether RangerTrooper-owned or operated or that of a contract manufacturer for any the Products or Product components) has been subject to a Governmental Body (including the FDA) shutdown or import or export detention, refusal or prohibition. Neither Ranger Trooper nor, to RangerTrooper’s knowledge, any manufacturing site which assists in the manufacture of any material Products or material Product components (whether RangerTrooper-owned or operated operated, or that of a contract manufacturer for the Products or Product components) has received, since December 31, 2011, any FDA Form 483 or other Governmental Body notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Ranger Trooper Licenses or alleging a lack of safety or effectiveness from the FDA or any other Governmental Body, and, to RangerTrooper’s knowledge, there is no such action or proceeding pending or threatened. (e) The FDA has not mandated that Ranger Trooper recall any of its Products. There are no recalls of any of RangerTrooper’s Products contemplated by Ranger Trooper or pending. Since December 31, 2011, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product component, or seizures ordered or adverse regulatory actions taken (or, to RangerTrooper’s knowledge, threatened) by the FDA or any Governmental Body with respect to any of the Products or Product components or any facilities where Products or Product components are developed, designed, tested, manufactured, assembled, processed, packaged or stored. (f) Except as set forth on Schedule 3.20(fin Section 4.20(f) of the Ranger Trooper Disclosure Letter, there are no clinical trials that are being conducted as of the date hereof by or on behalf of, or sponsored by, RangerTrooper. (g) Ranger Trooper is not the subject of any pending or, to the knowledge of RangerTrooper, threatened investigation regarding Ranger Trooper or the Products by the FDA pursuant to the FDA Fraud Policy. Neither Ranger nor, Trooper nor to the knowledge of RangerTrooper, any officer, employee, agent or distributor of Ranger Trooper has made an untrue statement of material fact to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Body to invoke the FDA Fraud Policy or any similar policy. Neither Ranger Trooper nor, to the knowledge of RangerTrooper, any officer, employee, agent or distributor of Ranger Trooper, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a debarment or exclusion are pending or, to the knowledge of RangerTrooper, threatened, against Ranger Trooper or, to the knowledge of RangerTrooper, any of its directors, officers, employees or agents.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Visor Material Adverse Effect, Ranger Visor is, and since December March 31, 20112012, has been, in compliance with all Healthcare Laws applicable to Ranger Visor and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Visor Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Ranger 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. Ranger Visor and, to RangerVisor’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 RangerVisor, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Visor Material Adverse Effect. Ranger 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, General or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Ranger Visor under any Healthcare Law. (b) Ranger Visor holds such Permits of Governmental Bodies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Ranger Visor Licenses”), except to the extent where the failure to hold such Permits would not, individually or in the aggregate, be reasonably expected to have a Ranger Visor Material Adverse Effect. Ranger Visor has fulfilled and performed all of its obligations with respect to each Ranger Visor License and is in material compliance with all terms and conditions of each Ranger Visor License, and, to RangerVisor’s knowledgeKnowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, suspension or termination thereof or would result in any other impairment of the rights of the holder of any Ranger Visor License, except to the extent where the failure to be in material compliance would not, individually or in the aggregate, be reasonably expected to have a Ranger Visor Material Adverse Effect. Ranger Visor has not received any written information or notification from the FDA or any other Governmental Body with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, distribution or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Body. (c) All material filings, reports, documents, claims, submissions and notices required to be filed, maintained or furnished to the FDA, state or other Governmental Bodies have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports, medical device reports and reports of corrections and removals with regard to the Products. All applications, notifications, submissions, information, claims, reports, filings and other data and conclusions derived therefrom utilized as the basis for, for or submitted in connection with, with any and all requests for a Ranger Visor License from the FDA or other Governmental Body relating to Ranger Visor or its businesses or the Products, when submitted to the FDA or any other Governmental Body, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to the FDA or other Governmental Body and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects respects, and do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading. (d) Ranger Visor has not received any written notice or other communication from the FDA or any other Governmental Body contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products or Product components (whether RangerVisor-owned or operated or that of a contract manufacturer for any the Products or Product components) has been subject to a Governmental Body (including the FDA) shutdown or import or export detention, refusal or prohibition. Neither Ranger Visor nor, to RangerVisor’s knowledgeKnowledge, any manufacturing site which assists in the manufacture of any material Products or material Product components (whether RangerVisor-owned or operated operated, or that of a contract manufacturer for the Products or Product components) has received, since December March 31, 20112012, any FDA Form 483 or other Governmental Body notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Ranger Visor Licenses or alleging a lack of safety or effectiveness from the FDA or any other Governmental Body, and, to RangerVisor’s knowledgeKnowledge, there is no such action or proceeding pending or threatened. (e) The FDA has not mandated that Ranger Visor recall any of its Products. There are no recalls of any of RangerVisor’s Products contemplated by Ranger Visor or pending. Since December March 31, 20112012, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product component, or seizures ordered or adverse regulatory actions taken (or, to RangerVisor’s knowledgeKnowledge, threatened) by the FDA or any Governmental Body with respect to any of the Products or Product components or any facilities where Products or Product components are developed, designed, tested, manufactured, assembled, processed, packaged or stored. (f) Except as set forth on Schedule 3.20(fSection 4.20(f) of the Ranger Visor Disclosure Letter, there are no clinical trials that are being conducted as of the date hereof by or on behalf of, or sponsored by, RangerVisor. (g) Ranger Visor is not the subject of any pending or, to the knowledge of RangerVisor’s Knowledge, threatened investigation regarding Ranger Visor or the Products by the FDA pursuant to the FDA Fraud Policy. Neither Ranger nor, Visor nor to the knowledge of RangerVisor’s Knowledge, any officer, employee, agent or distributor of Ranger Visor has made an untrue statement of material fact to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Body to invoke the FDA Fraud Policy or any similar policy. Neither Ranger Visor nor, to the knowledge of RangerVisor’s Knowledge, any officer, employee, agent or distributor of Ranger Visor, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a debarment or exclusion are pending or, to the knowledge of RangerVisor’s Knowledge, threatened, against Ranger Visor or, to the knowledge of RangerVisor’s Knowledge, any of its directors, officers, employees or agents.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Material Adverse EffectEffect on ReShape, Ranger ReShape is, and since December 31, 20112017, has been, in compliance with all Healthcare Laws applicable to Ranger ReShape and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Material Adverse EffectEffect on ReShape, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Ranger ReShape is being, and has been since December 31, 20112017, 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. Ranger ReShape and, to RangerReShape’s knowledge, any contract manufacturers assisting in the manufacture of the Products or Product components are, and, since December 31, 20112017, 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 RangerReShape, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Material Adverse EffectEffect on ReShape. Ranger ReShape 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, Ranger ReShape under any Healthcare Law. (b) Ranger ReShape holds such Permits of Governmental Bodies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Ranger ReShape Licenses”), except to the extent where the failure to hold such Permits would not, individually or in the aggregate, be reasonably expected to have a Ranger Material Adverse EffectEffect on ReShape. Ranger ReShape has fulfilled and performed all of its obligations with respect to each Ranger ReShape License and is in material compliance with all terms and conditions of each Ranger ReShape License, and, to RangerReShape’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, suspension or termination thereof or would result in any other impairment of the rights of the holder of any Ranger ReShape License, except to the extent where the failure to be in material compliance would not, individually or in the aggregate, be reasonably expected to have a Ranger Material Adverse EffectEffect on ReShape. Ranger ReShape has not received any written information or notification from the FDA or any other Governmental Body with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, distribution or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Body. (c) All material filings, reports, documents, claims, submissions and notices required to be filed, maintained or furnished to the FDA, state or other Governmental Bodies have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports, medical device reports and reports of corrections and removals with regard to the Products. All applications, notifications, submissions, information, claims, reports, filings and other data and conclusions derived ​ ​ therefrom utilized as the basis for, or submitted in connection with, any and all requests for a Ranger ReShape License from the FDA or other Governmental Body relating to Ranger ReShape or its businesses or the Products, when submitted to the FDA or any other Governmental Body, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to the FDA or other Governmental Body and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects and do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading. (d) Ranger ReShape has not received any written notice or other communication from the FDA or any other Governmental Body contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products or Product components (whether RangerReShape-owned or operated or that of a contract manufacturer for any Products or Product components) has been subject to a Governmental Body (including the FDA) shutdown or import or export detention, refusal or prohibition. Neither Ranger ReShape nor, to RangerReShape’s knowledge, any manufacturing site which assists in the manufacture of any material Products or material Product components (whether RangerReShape-owned or operated or that of a contract manufacturer for the Products or Product components) has received, since December 31, 20112017, any FDA Form 483 or other Governmental Body notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Ranger ReShape Licenses or alleging a lack of safety or effectiveness from the FDA or any other Governmental Body, and, to RangerReShape’s knowledge, there is no such action or proceeding pending or threatened. (e) The FDA has not mandated that Ranger ReShape recall any of its Products. There are no recalls of any of RangerReShape’s Products contemplated by Ranger ReShape or pending. Since December 31, 20112017, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product component, or seizures ordered or adverse regulatory actions taken (or, to RangerReShape’s knowledge, threatened) by the FDA or any Governmental Body with respect to any of the Products or Product components or any facilities where Products or Product components are developed, designed, tested, manufactured, assembled, processed, packaged or stored. (f) Except as set forth on Schedule Section 3.20(f) of the Ranger ReShape Disclosure LetterSchedule, there are no clinical trials that are being conducted as of the date hereof by or on behalf of, or sponsored by, RangerReShape. (g) Ranger ReShape is not the subject of any pending or, to the knowledge of RangerReShape, threatened investigation regarding Ranger ReShape or the Products by the FDA pursuant to the FDA Fraud Policy. Neither Ranger ReShape nor, to the knowledge of RangerReShape, any officer, employee, agent or distributor of Ranger ReShape has made an untrue statement of material fact to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Body to invoke the FDA Fraud Policy or any similar policy. Neither Ranger ReShape nor, to the knowledge of RangerReShape, any officer, employee, agent or distributor of Ranger ReShape has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a debarment or ​ ​ exclusion are pending or, to the knowledge of RangerReShape, threatened, against Ranger ReShape or, to the knowledge of RangerReShape, any of its directors, officers, employees or agents.

FDA and Regulatory Matters. (a) Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Union Material Adverse Effect, Ranger Union is, and since December March 31, 20112012, has been, in compliance with all Healthcare Laws applicable to Ranger Union and its Products. Except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Union Material Adverse Effect, the design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of Ranger 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. Ranger Union and, to RangerUnion’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 RangerUnion, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Ranger Union Material Adverse Effect. Ranger 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, or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Ranger Union under any Healthcare Law. (b) Ranger Union holds such Permits of Governmental Bodies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Ranger Union Licenses”), except to the extent where the failure to hold such Permits would not, individually or in the aggregate, be reasonably expected to have a Ranger Union Material Adverse Effect. Ranger Union has fulfilled and performed all of its obligations with respect to each Ranger Union License and is in material compliance with all terms and conditions of each Ranger Union License, and, to RangerUnion’s knowledgeKnowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation, suspension or termination thereof or would result in any other impairment of the rights of the holder of any Ranger Union License, except to the extent where the failure to be in material compliance would not, individually or in the aggregate, be reasonably expected to have a Ranger Union Material Adverse Effect. Ranger Union has not received any written information or notification from the FDA or any other Governmental Body with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, distribution or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Body. (c) All material filings, reports, documents, claims, submissions and notices required to be filed, maintained or furnished to the FDA, state or other Governmental Bodies have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports, medical device reports and reports of corrections and removals with regard to the Products. All applications, notifications, submissions, information, claims, reports, filings and other data and conclusions derived therefrom utilized as the basis for, or submitted in connection with, any and all requests for a Ranger Union License from the FDA or other Governmental Body relating to Ranger Union or its businesses or the Products, when submitted to the FDA or any other Governmental Body, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to the FDA or other Governmental Body and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects respects, and do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading. (d) Ranger Union has not received any written notice or other communication from the FDA or any other Governmental Body contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products or Product components (whether RangerUnion-owned or operated or that of a contract manufacturer for any the Products or Product components) has been subject to a Governmental Body (including the FDA) shutdown or import or export detention, refusal or prohibition. Neither Ranger Union nor, to RangerUnion’s knowledgeKnowledge, any manufacturing site which assists in the manufacture of any material Products or material Product components (whether RangerUnion-owned or operated or that of a contract manufacturer for the Products or Product components) has received, since December March 31, 20112012, any FDA Form 483 or other Governmental Body notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Body alleging or asserting noncompliance with any applicable Healthcare Laws or Ranger Union Licenses or alleging a lack of safety or effectiveness from the FDA or any other Governmental Body, and, to RangerUnion’s knowledgeKnowledge, there is no such action or proceeding pending or threatened. (e) The FDA has not mandated that Ranger Union recall any of its Products. There are no recalls of any of RangerUnion’s Products contemplated by Ranger Union or pending. Since December March 31, 20112012, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product component, or seizures ordered or adverse regulatory actions taken (or, to RangerUnion’s knowledgeKnowledge, threatened) by the FDA or any Governmental Body with respect to any of the Products or Product components or any facilities where Products or Product components are developed, designed, tested, manufactured, assembled, processed, packaged or stored. (f) Except as set forth on Schedule 3.20(f) of the Ranger Union Disclosure Letter, there are no clinical trials that are being conducted as of the date hereof by or on behalf of, or sponsored by, RangerUnion. (g) Ranger Union is not the subject of any pending or, to the knowledge of RangerUnion’s Knowledge, threatened investigation regarding Ranger Union or the Products by the FDA pursuant to the FDA Fraud Policy. Neither Ranger Union nor, to the knowledge of RangerUnion’s Knowledge, any officer, employee, agent or distributor of Ranger Union has made an untrue statement of material fact to the FDA or any other Governmental Body, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Body to invoke the FDA Fraud Policy or any similar policy. Neither Ranger Union nor, to the knowledge of RangerUnion’s Knowledge, any officer, employee, agent or distributor of Ranger Union has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a debarment or exclusion are pending or, to the knowledge of RangerUnion’s Knowledge, threatened, against Ranger Union or, to the knowledge of RangerUnion’s Knowledge, any of its directors, officers, employees or agents.