Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Governmental Entity is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company or any Company Subsidiary. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Governmental Entity. As of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 of the Company Disclosure Schedule, the Company and Company Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permits. The Company and Company Subsidiaries are not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Governmental Entity. The Company and Company Subsidiaries have made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign Laws, except to the extent that the failure to make such notifications, submission or reports would not have a Company Material Adverse Effect. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Super 8-K, the results of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder.

FDA and Related Matters. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Governmental Entity regulatory authority or governmental agency is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company or any Company SubsidiaryCompany. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Governmental Entityregulatory authority or governmental agency. As The Company has fulfilled and performed in all material respects its obligations under each such Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a the Company is not in breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 To the knowledge of the Company Disclosure ScheduleCompany, any third party that is a manufacturer or contractor for the Company and is in compliance in all material respects with all such Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company Subsidiaries have has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity governmental agency alleging or asserting noncompliance with any applicable Laws laws or Permits. The Company and Company Subsidiaries are is not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Governmental Entityregulatory authority or governmental agency. The Company and Company Subsidiaries have has made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign Lawslaws, except to the extent that the failure to make such notifications, submission or reports would not have a Company Material Adverse Effect. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Super 8-K, the results of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder.

FDA and Related Matters. (a) The conduct Companies and Seller Parties are and have been in compliance in all respects with (i) all applicable Laws of business the FDA and other Healthcare Regulatory Authorities (including all rules, regulations, policies, guidance document and guidelines of such Healthcare Regulatory Authorities which, although not necessarily having the force of law, are regarded by any Healthcare Regulatory Authority as requiring compliance as if it had the Company compliesforce of law), and at (ii) all times has substantially compliedHealthcare Regulatory Authorizations, in including all material respects with requirements of the Federal FoodFDA and all other Healthcare Regulatory Authorities, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws that are applicable to the evaluationCompanies or Seller Parties, testingor by which any property, manufacturingproduct, distribution, advertising and marketing of each or other asset of the Company’s productsCompanies or Seller (including, in whatever stage without limitation, any Product Candidate (as defined below)) is bound or affected. No Company or Seller Party has received any written notification of development or commercialization except any pending or, to the extent that Knowledge of Seller Parties, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the failure FDA or other Healthcare Regulatory Authorities, and to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Governmental Entity is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company or any Company Subsidiary. To the knowledge of the CompanySeller Parties’ Knowledge, there is no reasonable basis for any such claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action. (b) The Companies and Seller have held all Healthcare Regulatory Authorizations required for the conduct of the Business as currently conducted, and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allows, or after notice or lapse of time would allow or result in, and the Restructuring will not result in, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization. (c) Section 3.20 of the Disclosure Schedule contains a complete and accurate list of all of the Product Candidates of the Companies or Seller, listing, where applicable, those Product Candidates for which the Companies or Seller have applied for or have authorization to test the product in human subjects (“Human Testing Authorization”) according to applicable Laws and listing the type of application made or currently in effect. For those Product Candidates listed in Section 3.20 of the Disclosure Schedule as having received FDA and/or other Human Testing Authorization which are currently under development (including where such Human Testing Authorization has been received as a result of the absence of a notice from a Health Regulatory Authority after a specified amount of time), such Human Testing Authorization has not been revoked, suspended, cancelled or rescinded. No notification has been received by any Company or Seller Party from any Governmental Body, a notified body or any other party that would reasonably be expected to preclude the Companies or Seller from continuing to test such Product Candidates. No applications made or other materials submitted by the Companies or Seller Parties to FDA and other Healthcare Regulatory Authorities contained an untrue statement of material fact, fraudulent statement or omitted to state a material omission fact required to be stated therein or necessary in any product application or other submission by order to make the Company or any Company Subsidiary to the FDA or any comparable Governmental Entity. As statements contained therein, in light of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists circumstances under which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 of the Company Disclosure Schedule, the Company and Company Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permits. The Company and Company Subsidiaries are not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Governmental Entity. The Company and Company Subsidiaries have made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign Laws, except to the extent that the failure to make such notifications, submission or reports would not have a Company Material Adverse Effect. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Super 8-K, the results of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder.they were

FDA and Related Matters. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Governmental Entity regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company or any Company Subsidiaryof its Subsidiaries. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product application or other submission by the Company or any Company Subsidiary of its Subsidiaries to the FDA or any comparable Governmental Entityregulatory authority or governmental agency. As The Company or its Subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 To the knowledge of the Company Disclosure ScheduleCompany, any third party that is a manufacturer or contractor for the Company or any of its Subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and Company its Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity governmental agency alleging or asserting noncompliance with any applicable Laws laws or Permits. The Company and Company its Subsidiaries are not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Governmental Entityregulatory authority or governmental agency. The Company and Company its Subsidiaries have made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign Lawslaws, except to the extent that the failure to make such notifications, submission or reports would not have a Company Material Adverse Effect. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Super 8-K, the results of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder.

FDA and Related Matters. (a) The Company has all Registrations required to conduct its business as currently conducted, and Section 3.23(a) of business by the Company compliesDisclosure Schedule sets forth a true, complete and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each correct list as of the Company’s products, date of this Agreement of such Registrations. Each of the Registrations is valid and subsisting in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effectfull force and effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Entity is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws such Registration or changing the marketing classification or labeling of the products of the Company or any Company SubsidiaryCompany. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Regulatory Authority or Governmental Entity. As The Company has fulfilled and performed in all material respects its obligations under each Registration, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except Registration. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is in compliance with all Registrations insofar as they pertain to the extent that such breachmanufacture of product components or products for the Company. (b) All products developed, defaulttested, revocation investigated, manufactured, distributed, marketed or termination would not have a Company Material Adverse Effect. Except as set forth sold by or on Section 2.31 behalf of the Company Disclosure Schedulethat are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, distributed, marketed and sold in all material respects in compliance with FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company, or any other applicable Law, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. To the knowledge of the Company, except as would not be material to the Company, any third party that is a manufacturer or contractor for the Company and is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of product components or products for the Company. (c) There are no enforcement actions (including any administrative proceeding, prosecution, injunction, seizure, civil penalty or debarment action) pending or threatened by or on behalf of FDA or any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company. The Company Subsidiaries have has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or PermitsRegistrations. The Company and Company Subsidiaries are is not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity. The Company and Company Subsidiaries have has made all notifications, submissions and reports required by FDA Laws or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDCA FDA or similar federal, state any comparable Regulatory Authority or Governmental Entity and foreign Laws, except to the extent that the failure to make all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or reports would not have a any comparable Regulatory Authority or Governmental Entity. To the knowledge of the Company, as of the date hereof, no basis for liability exists with respect to any such notification, submission, or report. (d) Except as set forth on Section 3.23(d) of the Company Material Adverse Effect. The preclinical studiesDisclosure Schedule, tests and clinical trials conducted no product distributed or sold by or on behalf of the Company (the “Company Studies has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions as of the results date hereof, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure or suspension of the Company Studies and Trials contained marketing or distribution (including for commercial, investigational or any other use) of any such product. No proceedings in the Super 8-K United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such product are accurate in all material respects; pending or, to the Company has no knowledge of any other studies or trials not described in the Super 8-KCompany, threatened against the results Company. (e) To the knowledge of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreignCompany, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received all data generated by the Company in connection with the Company Studies respect to its products that has been provided to its customers or otherwise made public is truthful and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereundernot misleading.

FDA and Related Matters. (a) The Company and each Company Subsidiary holds, and is operating in material compliance with, all material Registrations required to conduct the business of business by the Company compliesand the Company Subsidiaries as currently conducted, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”Section 2.21(a) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s productsDisclosure Schedule sets forth a true, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, complete and correct list as of the date hereofhereof of such Registrations. Each of the Registrations is valid and subsisting in full force and effect. Neither the Company nor any Company Subsidiary has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from a Regulatory Authority or other Governmental Entity alleging that any operation or activity of the Company or any Company Subsidiary is in violation of the Registrations. To the Company’s Knowledge, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Entity is considering materially limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws such Registration or changing the marketing classification or labeling of the products of the Company or any Company SubsidiaryProducts. To the knowledge of Except as would not reasonably be expected to have a material impact on the Company, there has not been and is currently no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product Product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Regulatory Authority or Governmental Entity. As of the date hereof, Except as would not reasonably be expected to the knowledge of have a material impact on the Company, the Company and each Company Subsidiary has fulfilled and performed its obligations under each Registration, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit Registration. To the Company’s Knowledge, and except as would not reasonably be expected to have a material impact on the Company, any third party that is a manufacturer or contractor for the Company or any Company Subsidiary is in compliance with all Registrations insofar as they pertain to, or affect, the manufacture of Product components or Products for the Company or any Company Subsidiary. (b) Except as would not reasonably be expected to have a material impact on the Company, all Products developed, tested, investigated, manufactured, processed, produced, distributed, advertised, commercialized, marketed, imported, exported or sold by or on behalf of the Company or any Company Subsidiary that are subject to the extent jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, processed, produced, distributed, advertised, commercialized, marketed, imported, exported and sold in compliance with FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company or such breachCompany Subsidiary, defaultas applicable, revocation or termination would not have a Company Material Adverse Effectand any other applicable Law, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification and pre-market approval, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. Except as set forth would not reasonably be expected to have a material impact on Section 2.31 the Company, the Company has operated in compliance with applicable Laws related to the testing, investigation, manufacturing, processing, production, distribution, advertising, commercialization, marketing, import, export, and sale of its Products, including, without limitation, the FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity, and any other applicable Laws. To the Company’s Knowledge, except as would not reasonably be expected to have a material impact on the Company any third party that is a manufacturer or contractor for the Company or any Company Subsidiary is in compliance with all FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company Disclosure Scheduleand any other applicable Law insofar as they pertain to, or affect, the manufacture of Product components or Products for the Company and or such Company Subsidiaries have not Subsidiary. (c) There are no enforcement actions (including any administrative Proceeding, prosecution, injunction, seizure, civil penalty, exclusion or debarment action) pending or threatened by or on behalf of FDA or any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company or any Company Subsidiary. Neither the Company nor any Company Subsidiary has had any Product or manufacturing site (whether Company or Company Subsidiary-owned or that of a contract manufacturer for Products) subject to a Regulatory Authority or Governmental Entity (including FDA) shutdown or import or export prohibition, or received any Form FDA-483FDA-483 or other Governmental Entity notice of inspectional observations, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other written notice from the FDA or other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or PermitsRegistrations, or requests or requirements to make changes to the Products that if not complied with could have a material impact on the Products or the Company. The Neither the Company and nor any Company Subsidiaries are not Subsidiary is subject to any obligation arising under an administrative or regulatory enforcement action, FDA or other Governmental Entity inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity, or any other written communication from any Regulatory Authority or Governmental Entity alleging or asserting material noncompliance with any applicable Laws, including the FDA Laws. The Company and each Company Subsidiaries have Subsidiary has made all applications, notifications, submissions, information, claims and reports required by FDA Laws or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity and all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Entity, and any necessary or required updates, changes, corrections, or modification to such applications, notifications, submissions, information, claims and reports have been submitted to such Regulatory Authority or other Governmental Entity. To the Company’s Knowledge, no basis for liability exists with respect to any such notification, submission, information, claim or report. To the extent any adverse events have occurred, any and all known adverse events have been reported to FDA as required by the FDCA FDA Laws. (d) Except as set forth on Section 2.21(d) of the Disclosure Schedule, no Product distributed or similar federalsold by or on behalf of the Company or any Company Subsidiary has been seized, state withdrawn, recalled, detained or subject to a suspension of manufacturing, and foreign to the Company’s Knowledge, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such Product; (ii) a material change in the labeling of any such Product; or (iii) a termination, seizure or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such Product. No Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such Product are pending or, to Company’s Knowledge, threatened against the Company or any Company Subsidiary. (e) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or any Company Subsidiary or in which the Company, any Company Subsidiary or their Products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the FDA Laws and FDA’s applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812, except as would not reasonably be expected to have a material impact on the Company. Except to the extent that disclosed on Section 2.21(e) of the failure Disclosure Schedule, no investigational device exemption filed by or on behalf of the Company or any Company Subsidiary with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to make such notificationsthe Company’s Knowledge, submission threatened to initiate, any action to place a clinical hold order on, or reports would not have a Company Material Adverse Effect. The preclinical studiesotherwise terminate, tests and delay or suspend, any proposed or ongoing clinical trials investigation conducted or proposed to be conducted by or on behalf of the Company or any Company Subsidiary. To the Company’s Knowledge, all data generated by the Company and each Company Subsidiary with respect to its Products that has been provided to its customers or otherwise made public is truthful and not misleading. (f) Neither the “Company Studies and Trials”) were andnor any Company Subsidiary is the subject of any pending or, if still pendingto the Company’s Knowledge, are being, conducted threatened investigation in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions respect of the results Company, any Company Subsidiary or any Products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of the Company, any Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company Subsidiary or any of their respective officers, employees or agents has no knowledge been convicted of any other studies crime or trials not described engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar Law. As of the Super 8-Kdate hereof, to the results of which are materially inconsistent with Company’s Knowledge, no claims, actions, proceedings or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification investigations that would reasonably be expected to have result in such a Material Adverse Effect. The Company has obtained (debarment or caused to be obtained) informed consent by exclusion are pending or on behalf of each human subject who participated in threatened against the Company Studies and Trials. In using or disclosing patient information received by the any Company in connection with the Company Studies and TrialsSubsidiary or any of their respective officers, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunderemployees or agents.

FDA and Related Matters. (a) The Company has all Registrations required to conduct its business as currently conducted, and Section 3.23(a) of business by the Company compliesDisclosure Schedule sets forth a true, complete and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each correct list as of the Company’s products, date of this Agreement of such Registrations. Each of the Registrations is valid and subsisting in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effectfull force and effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “"FDA”") nor any comparable Regulatory Authority or Governmental Entity is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws such Registration or changing the marketing classification or labeling of the products of the Company or any Company SubsidiaryCompany. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Regulatory Authority or Governmental Entity. As The Company has fulfilled and performed in all material respects its obligations under each Registration, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except Registration. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is in compliance with all Registrations insofar as they pertain to the extent that such breachmanufacture of product components or products for the Company. (b) All products developed, defaulttested, revocation investigated, manufactured, distributed, marketed or termination would not have a Company Material Adverse Effect. Except as set forth sold by or on Section 2.31 behalf of the Company Disclosure Schedulethat are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, distributed, marketed and sold in all material respects in compliance with FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company, or any other applicable Law, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. To the knowledge of the Company, except as would not be material to the Company, any third party that is a manufacturer or contractor for the Company and is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of product components or products for the Company. (c) There are no enforcement actions (including any administrative proceeding, prosecution, injunction, seizure, civil penalty or debarment action) pending or threatened by or on behalf of FDA or any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company. The Company Subsidiaries have has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “"untitled letter,” " notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or PermitsRegistrations. The Company and Company Subsidiaries are is not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity. The Company and Company Subsidiaries have has made all notifications, submissions and reports required by FDA Laws or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDCA FDA or similar federal, state any comparable Regulatory Authority or Governmental Entity and foreign Laws, except to the extent that the failure to make all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or reports would not have a any comparable Regulatory Authority or Governmental Entity. To the knowledge of the Company, as of the date hereof, no basis for liability exists with respect to any such notification, submission, or report. (d) Except as set forth on Section 3.23(d) of the Company Material Adverse Effect. The preclinical studiesDisclosure Schedule, tests and clinical trials conducted no product distributed or sold by or on behalf of the Company (the “Company Studies has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions as of the results date hereof, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure or suspension of the Company Studies and Trials contained marketing or distribution (including for commercial, investigational or any other use) of any such product. No proceedings in the Super 8-K United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such product are accurate in all material respects; pending or, to the Company has no knowledge of any other studies or trials not described in the Super 8-KCompany, threatened against the results Company. (e) To the knowledge of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreignCompany, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received all data generated by the Company in connection with the Company Studies respect to its products that has been provided to its customers or otherwise made public is truthful and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereundernot misleading.

FDA and Related Matters. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s medical device products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Company Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Governmental Entity is considering limiting, suspending or revoking any such Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company or any Company Subsidiary. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement false or misleading information or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Governmental Entity. As The Company or Company Subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company Disclosure Schedule, or any Company Subsidiary is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and Company Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permits. The Company and Company Subsidiaries are not subject to any obligation arising under an administrative or regulatory enforcement action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Governmental Entity. The Company and Company Subsidiaries have made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign Laws, except to the extent that the failure to make such notifications, submission or reports would not have a Company Material Adverse Effect. The preclinical studies, tests and clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Super 8-K are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Super 8-K, the results of which are materially inconsistent with or call into question the results described or referred to in the Super 8-K; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination or suspension or material modification of any Company Studies and Trials, which termination or suspension or material modification would reasonably be expected to have a Material Adverse Effect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder.