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 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 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. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority or governmental agency. 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, the Company is not in breach or default of any such Permit except to the extent that such breach, default, would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company 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 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 agency alleging or asserting noncompliance with any applicable laws or Permits. The Company is not subject to any obligation arising under an 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 agency. The Company has 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 Material Adverse Effect.

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 regulatory authority or governmental agency 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 CompanyCompany or any Company Subsidiary. To the knowledge of the Company, there is no false or misleading information 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 regulatory authority or governmental agencyGovernmental Entity. The Company has fulfilled and performed in all material respects its obligations under each such Permit, and, as As of the date hereof, to the knowledge of the Company, the Company is not in 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. To the knowledge Except as set forth on Section 2.31 of the CompanyCompany Disclosure Schedule, any third party that is a manufacturer or contractor for the Company 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 and Company has 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 agency Governmental Entity alleging or asserting noncompliance with any applicable laws Laws or Permits. The Company is 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 regulatory authority or governmental agencyGovernmental Entity. The Company has and Company 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 conduct of business by the Company complies, Companies and at all times has substantially complied, in all material respects with the Federal Food, Drug Seller Parties are 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 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 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. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority or governmental agency. 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, the Company is not in breach or default of any such Permit except to the extent that such breach, default, would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is been in compliance in all material respects with (i) all applicable Laws of the FDA and other Healthcare Regulatory Authorities (including all rules, regulations, policies, guidance document and guidelines of such Permits insofar Healthcare Regulatory Authorities which, although not necessarily having the force of law, are regarded by any Healthcare Regulatory Authority as they pertain requiring compliance as if it had the force of law), and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA and all other Healthcare Regulatory Authorities, that are applicable to the manufacture Companies or Seller Parties, or by which any property, product, or other asset of product components the Companies or products for the CompanySeller (including, without limitation, any Product Candidate (as defined below)) is bound or affected. The No Company or Seller Party has not received any Form FDA-483written notification of any pending or, notice to the Knowledge of adverse findingSeller Parties, FDA warning letterthreatened, notice of violation claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or “untitled letter,” notice of FDA other action for import detention or refusal, or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with Healthcare Regulatory Authorities, and to Seller Parties’ Knowledge, there is no reasonable basis for any applicable laws or Permits. The Company is not subject to any obligation arising under an administrative or regulatory actionsuch claim, FDA inspectionsuit, FDA warning letterproceeding, FDA notice of violation letter hearing, enforcement, audit, investigation, arbitration or other noticeaction. (b) The Companies and Seller have held all Healthcare Regulatory Authorizations required for the conduct of the Business as currently conducted, response and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allows, or commitment 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 to or with 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 comparable regulatory authority other party that would reasonably be expected to preclude the Companies or governmental agencySeller from continuing to test such Product Candidates. The Company has No applications made all notifications, submissions and reports required or other materials submitted by the FDCA Companies or similar federalSeller Parties to FDA and other Healthcare Regulatory Authorities contained an untrue statement of material fact, or omitted to state and foreign laws, except a material fact required to the extent that the failure be stated therein or necessary in order to make such notificationsthe statements contained therein, submission or reports would not have a Material Adverse Effect.in light of the circumstances under which 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”a) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each Each of the Company’s products, Companies possesses all Registrations required to conduct its Business as currently conducted. Each such Registration 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 Material Adverse Effectfull force and effect. To the knowledge Knowledge of the CompanyShareholder, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”FDAˮ) nor any comparable regulatory authority Regulatory Authority or governmental agency Governmental Authority 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 Products of each of the CompanyCompanies. To the knowledge Knowledge of the CompanyShareholder, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority Regulatory Authority or governmental agencyGovernmental Authority. The Company has Except as set forth on Schedule 2.28(a), each of the Companies is in compliance with, and have fulfilled and performed in all material respects its their respective obligations under under, each such PermitRegistration, and, as of the date hereof, to the knowledge Knowledge of the CompanyShareholder, the Company is not in 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, would not have a Material Adverse EffectRegistration. To the knowledge Knowledge of the CompanyShareholder, any third party Person that is a manufacturer or contractor for each of the Company Companies is in compliance in all material respects with all such Permits Registrations insofar as they pertain to the manufacture of product components or products Products for each of the CompanyCompanies. (b) All Products developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of each of the Companies that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the operations of each of the Companies, including, to the Knowledge of the Shareholder, 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, except where the failure to be in compliance would not have a Material Adverse Effect. The Except as set forth on Schedule 2.28(b), to the Knowledge of the Shareholder, except as would not have a Material Adverse Effect, taken as a whole, any third Person that is a manufacturer or Contractor for each of the Companies 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 each of the Companies. (c) As of the date hereof, there are no Proceedings pending or, to the Knowledge of the Shareholder, threatened by or on behalf of any Regulatory Authority that has jurisdiction over the operations of each of the Companies. Except as set forth in Schedule 2.28(c), as of the date hereof, no Company 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 any other governmental agency Governmental Authority alleging or asserting noncompliance with any applicable laws Laws or PermitsRegistrations. The Company Except as set forth in Schedule 2.28(c), each of the Companies is not subject to any obligation arising under an 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 agencyRegulatory Authority. The Company Each of the Companies has made all notifications, submissions submissions, responses and reports required by FDA Laws, 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 Authority and foreign laws, except to the extent that the failure to make all such notifications, submissions, responses and reports were true, complete and correct in all material respects as of the date of submission to the FDA or reports would Shareholder comparable Regulatory Authority or Governmental Authority. To the Knowledge of the Shareholder, 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 Schedule 2.28(d), no Product distributed or sold by or on behalf of any of the Companies has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the date hereof, to the Knowledge of the Shareholder, 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, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such Product. As of the date hereof, no Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such Product are pending or, to the Knowledge of the Shareholder, threatened against any of the Companies. As of the date hereof, each of the Companies has not received any notice from a Regulatory Authority or other Governmental Authority that any Product distributed or sold by or on behalf of any of the Companies cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of any of the Companies. (e) All preclinical and clinical investigations sponsored or conducted by or on behalf of each of the Companies have been and are being conducted in material compliance with all applicable Laws and other requirements, including good clinical practices requirements, other FDA Laws, applicable research protocols, corrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of any of the Companies has been terminated, materially delayed, limited or suspended prior to completion by the FDA, any other applicable Regulatory Authority, or any institutional review board that has or has had jurisdiction over such clinical trial, and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a Material Adverse Effectclinical trial conducted or sponsored by or on behalf of any of the Companies, has ordered or commenced, or, to the Knowledge of the Shareholder, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any of the Companies, or, to the Knowledge of the Shareholder, alleged any violation of any FDA Law in connection with any such clinical trial.

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 regulatory authority or governmental agency 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 CompanyCompany or any Company Subsidiary. To the knowledge of the Company, there is no 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 agencyGovernmental Entity. The Company has or Company Subsidiaries have fulfilled and performed in all material respects its their obligations under each such Permit, and, as of the date hereof, to the knowledge of the Company, the Company is not in 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. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any Company Subsidiary 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 has 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 agency Governmental Entity alleging or asserting noncompliance with any applicable laws Laws or Permits. The Company is and Company Subsidiaries are not subject to any obligation arising under an 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 agencyGovernmental Entity. The Company has and Company 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.

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 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 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 CompanyCompany or any of its Subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its Subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company has or its Subsidiaries have fulfilled and performed in all material respects its their obligations under each such Permit, and, as of the date hereof, to the knowledge of the Company, the Company is not in 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 Material Adverse Effect. To the knowledge of the Company, 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 such Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company has and 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 agency alleging or asserting noncompliance with any applicable laws or Permits. The Company is and its Subsidiaries are not subject to any obligation arising under an 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 agency. The Company has and its 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 Material Adverse Effect.

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 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 Regulatory Authority or governmental agency 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. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority Regulatory Authority or governmental agencyGovernmental Entity. The Company has fulfilled and performed in all material respects its obligations under each such PermitRegistration, and, as of the date hereof, to the knowledge of the Company, the Company is not in 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, would not have a Material Adverse EffectRegistration. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is in compliance in all material respects with all such Permits Registrations insofar as they pertain to the manufacture of product components or products for the Company. (b) All products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of the Company that 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 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 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 agency Governmental Entity alleging or asserting noncompliance with any applicable laws Laws or PermitsRegistrations. The Company is not subject to any obligation arising under an 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 Regulatory Authority or governmental agencyGovernmental Entity. The Company 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 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 Disclosure Schedule, no product distributed or sold by or on behalf of the Company has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the 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 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 the knowledge of the Company, threatened against the Company. (e) To the knowledge of the Company, all data generated by the Company with respect to its products that has been provided to its customers or otherwise made public is truthful and not have a Material Adverse Effectmisleading.