Common use of Governmental Authorizations; Regulatory Compliance Clause in Contracts

Governmental Authorizations; Regulatory Compliance. (a) Part 4.6 of the ReShape Disclosure Schedule identifies: (i) each Governmental Authorization that is held by ReShape and/or any ReShape Affiliate that relates to or is used in the ReShape IGB Business; and (ii) each other Governmental Authorization that is held by any Representative of ReShape or any ReShape Affiliate and relates to or is useful in connection with the ReShape IGB Business. ReShape has delivered to Apollo accurate and complete copies of all of the Governmental Authorizations identified in Part 4.6 of the ReShape Disclosure Schedule, including all renewals thereof and all amendments thereto. Each Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule is valid and in full force and effect. Except as set forth in Part 4.6 of the ReShape Disclosure Schedule: (A) ReShape is and has at all times been in full compliance with all of the terms and requirements of each Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule; (B) no event has occurred, and no condition or circumstance exists, that might (with or without notice or lapse of time) (x) constitute or result directly or indirectly in a violation of or a failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule, or (y) result directly or indirectly in the revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule; (C) neither ReShape nor any ReShape Affiliate has ever received any notice or other communication (in writing or otherwise) from any Governmental Body or any other Person regarding (x) any actual, alleged, possible or potential violation of or failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule, or (y) any actual, proposed, possible or potential revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule; and (D) all applications required to have been filed for the renewal of the Governmental Authorizations identified or required to be identified in Part 4.6 of the ReShape Disclosure Schedule have been duly filed on a timely basis with the appropriate Governmental Bodies, and each other notice or filing required to have been given or made with respect to such Governmental Authorizations has been duly given or made on a timely basis with the appropriate Governmental Body. The Governmental Authorizations identified in Part 4.6 of the ReShape Disclosure Schedule constitute all of the Governmental Authorizations necessary (1) to enable ReShape to conduct the Business in the manner in which such business is currently being conducted, and (2) to permit ReShape to own and use the ReShape IGB Assets in the manner in which they are currently owned and used. (b) Each ReShape IGB Product is being or has been developed, manufactured, labeled, stored, researched, distributed and/or tested in compliance in all material respects with all applicable requirements under the FFDCA, applicable implementing regulations and similar foreign, state and local Laws and regulations, including those relating to investigational use, quality systems, good manufacturing practices, good clinical practices, good laboratory practices, labeling, record keeping and filing of required reports. Neither ReShape nor any ReShape Affiliate has received any notice or other communication from the FDA or any other Governmental Body alleging any violation of any Laws or judgments applicable to any ReShape IGB Product and/or ReShape IGB Asset. Complete and accurate copies of all data of ReShape, and all correspondence with the FDA and foreign health authorities, with respect to each ReShape IGB Product have been made available for Apollo’s review. (c) ReShape has filed, or a ReShape Affiliate or Third Party on behalf of ReShape has filed, with the FDA or other appropriate Governmental Body all required notices, any ReShape IGB Product Medical Device Reports under 21 CFR Part 803 related to the use of any ReShape IGB Product in human clinical trials, and ReShape has made copies of such notices available for Apollo’s review. (d) Neither ReShape nor, to the Knowledge of ReShape, any of ReShape’s Representatives acting for ReShape, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its Fraud Policy and any amendments thereto. Additionally, neither ReShape, nor to the Knowledge of ReShape, any Representative of ReShape has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar state Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Law. To the Knowledge of ReShape, ReShape is not the target of any pending or threatened investigation by the FDA pursuant to the Fraud Policy or by any Governmental Body pursuant to a comparable policy. (e) There are no investigations, suits, arbitrations, charges, complaints, claims, actions or proceedings against or affecting ReShape relating to or arising under the FFDCA, the Public Health Service Act, the FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Governmental Body.

Governmental Authorizations; Regulatory Compliance. (a) Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule identifies: (i) each Governmental Authorization that is held by ReShape Apollo and/or any ReShape Apollo Affiliate that relates to or is used in the ReShape IGB Apollo Lap-Band Business; and (ii) each other Governmental Authorization that is held by any Representative of ReShape Apollo or any ReShape Apollo Affiliate and relates to or is useful in connection with the ReShape IGB Apollo Lap-Band Business. ReShape Apollo has delivered to Apollo ReShape accurate and complete copies of all of the Governmental Authorizations identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, including all renewals thereof and all amendments thereto. Each Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule is valid and in full force and effect. Except as set forth in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule: (A) ReShape Apollo is and has at all times been in full compliance with all of the terms and requirements of each Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; (B) no event has occurred, and no condition or circumstance exists, that might (with or without notice or lapse of time) (x) constitute or result directly or indirectly in a violation of or a failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, or (y) result directly or indirectly in the revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; (C) neither ReShape Apollo nor any ReShape Apollo Affiliate has ever received any notice or other communication (in writing or otherwise) from any Governmental Body or any other Person regarding (x) any actual, alleged, possible or potential violation of or failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, or (y) any actual, proposed, possible or potential revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; and (D) all applications required to have been filed for the renewal of the Governmental Authorizations identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule have been duly filed on a timely basis with the appropriate Governmental Bodies, and each other notice or filing required to have been given or made with respect to such Governmental Authorizations has been duly given or made on a timely basis with the appropriate Governmental Body. The Governmental Authorizations identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule constitute all of the Governmental Authorizations necessary (1) to enable ReShape Apollo to conduct the Business in the manner in which such business is currently being conducted, and (2) to permit ReShape Apollo to own and use the ReShape IGB Apollo Lap-Band Assets in the manner in which they are currently owned and used. (b) Each ReShape IGB Apollo Lap-Band Product is being or has been developed, manufactured, labeled, stored, researched, distributed and/or tested in compliance in all material respects with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FFDCA”), applicable implementing regulations and similar foreign, state and local Laws and regulations, including those relating to investigational use, quality systems, good manufacturing practices, good clinical practices, good laboratory practices, labeling, record keeping and filing of required reports. Neither ReShape Apollo nor any ReShape Apollo Affiliate has received any notice or other communication from the FDA or any other Governmental Body alleging any violation of any Laws or judgments applicable to any ReShape IGB Apollo Lap-Band Product and/or ReShape IGB Apollo Lap-Band Asset. Complete and accurate copies of all data of ReShapeApollo, and all correspondence with the FDA and foreign health authorities, with respect to each ReShape IGB Apollo Lap-Band Product have been made available for ApolloReShape’s review. (c) ReShape Apollo has filed, or a ReShape an Apollo Affiliate or Third Party on behalf of ReShape Apollo has filed, with the FDA or other appropriate Governmental Body all required notices, any ReShape IGB Apollo Lap-Band Product Medical Device Reports under 21 CFR Part 803 related to the use of any ReShape IGB Apollo Lap Band Product in human clinical trials, and ReShape Apollo has made copies of such notices available for ApolloReShape’s review. (d) Neither ReShape Apollo nor, to the Knowledge of ReShapeApollo, any of ReShapeApollo’s Representatives acting for ReShapeApollo, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “Fraud Policy Policy”) and any amendments thereto. Additionally, neither ReShapeApollo, nor to the Knowledge of ReShapeApollo, any Representative of ReShape Apollo has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar state Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Law. To the Knowledge of ReShapeApollo, ReShape Apollo is not the target of any pending or threatened investigation by the FDA pursuant to the Fraud Policy or by any Governmental Body pursuant to a comparable policy. (e) There are no investigations, suits, arbitrations, charges, complaints, claims, actions or proceedings against or affecting ReShape Apollo relating to or arising under the FFDCA, the Public Health Service Services Act, the FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Governmental Body.

Governmental Authorizations; Regulatory Compliance. (a) Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule identifies: (i) each Governmental Authorization that is held by ReShape Apollo and/or any ReShape Apollo Affiliate that relates to or is used in the ReShape IGB Apollo Lap-Band Business; and (ii) each other Governmental Authorization that is held by any Representative of ReShape Apollo or any ReShape Apollo Affiliate and relates to or is useful in connection with the ReShape IGB Apollo Lap-Band Business. ReShape Apollo has delivered to Apollo ReShape accurate and complete copies of all of the Governmental Authorizations identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, including all renewals thereof and all amendments thereto. Each Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule is valid and in full force and effect. Except as set forth in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule: (A) ReShape Apollo is and has at all times been in full compliance with all of the terms and requirements of each Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; (B) no event has occurred, and no condition or circumstance exists, that might (with or without notice or lapse of time) (x) constitute or result directly or indirectly in a violation of or a failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, or (y) result directly or indirectly in the revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; (C) neither ReShape Apollo nor any ReShape Apollo Affiliate has ever received any notice or other communication (in writing or otherwise) from any Governmental Body or any other Person regarding (x) any actual, alleged, possible or potential violation of or failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule, or (y) any actual, proposed, possible or potential revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule; and (D) all applications required to have been filed for the renewal of the Governmental Authorizations identified or required to be identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule have been duly filed on a timely basis with the appropriate Governmental Bodies, and each other notice or filing required to have been given or made with respect to such Governmental Authorizations has been duly given or made on a timely basis with the appropriate Governmental Body. The Governmental Authorizations identified in Part 4.6 3.6 of the ReShape Apollo Disclosure Schedule constitute all of the Governmental Authorizations necessary (1) to enable ReShape Apollo to conduct the Business in the manner in which such business is currently being conducted, and (2) to permit ReShape Apollo to own and use the ReShape IGB Apollo Lap-Band Assets in the manner in which they are currently owned and used. (b) Each ReShape IGB Apollo Lap-Band Product is being or has been developed, manufactured, labeled, stored, researched, distributed and/or tested in compliance in all material respects with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FFDCA”), applicable implementing regulations and similar foreign, state and local Laws and regulations, including those relating to investigational use, quality systems, good manufacturing practices, good clinical practices, good laboratory practices, labeling, record keeping and filing of required reports. Neither ReShape Apollo nor any ReShape Apollo Affiliate has received any notice or other communication from the FDA or any other Governmental Body alleging any violation of any Laws or judgments applicable to any ReShape IGB Apollo Lap-Band Product and/or ReShape IGB and/ or Apollo Lap-Band Asset. Complete and accurate copies of all data of ReShapeApollo, and all correspondence with the FDA and foreign health authorities, with respect to each ReShape IGB Apollo Lap-Band Product have been made available for ApolloReShape’s review. (c) ReShape Apollo has filed, or a ReShape an Apollo Affiliate or Third Party on behalf of ReShape Apollo has filed, with the FDA or other appropriate Governmental Body all required notices, any ReShape IGB Apollo Lap-Band Product Medical Device Reports under 21 CFR Part 803 related to the use of any ReShape IGB Apollo Lap Band Product in human clinical trials, and ReShape Apollo has made copies of such notices available for ApolloReShape’s review. (d) Neither ReShape Apollo nor, to the Knowledge of ReShapeApollo, any of ReShapeApollo’s Representatives acting for ReShapeApollo, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “Fraud Policy Policy”) and any amendments thereto. Additionally, neither ReShapeApollo, nor to the Knowledge of ReShapeApollo, any Representative of ReShape Apollo has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar state Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Law. To the Knowledge of ReShapeApollo, ReShape Apollo is not the target of any pending or threatened investigation by the FDA pursuant to the Fraud Policy or by any Governmental Body pursuant to a comparable policy. (e) There are no investigations, suits, arbitrations, charges, complaints, claims, actions or proceedings against or affecting ReShape Apollo relating to or arising under the FFDCA, the Public Health Service Services Act, the FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Governmental Body.