(b) Neither the Company, its Subsidiaries, nor any of their respective directors, officers or managers, or, to the Knowledge of the Company, managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)) is or has been: (i) debarred, disqualified, excluded, or suspended by any Governmental Authority (including the FDA pursuant to its authority under 21 U.S.C. § 335a and 21 C.F.R. § 812.119); (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act in connection with any material violation of any Governmental Health Program requirement; (iii) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service under a Governmental Health Program. Except as has not had, and would not reasonably be expected to have, a Company Material Adverse Effect, neither the Company, its Subsidiaries, nor any of their respective directors, officers or managers, or, to the Knowledge of the Company, managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)) has been or is a party to, nor has any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement agreements, criminal actions, plans of correction or similar agreements or Orders with or imposed by any Governmental Authority concerning any Healthcare Law or Medical Device Law.
(c) Except as has not had, and would not reasonably be expected to have, a Company Material Adverse Effect, since January 1, 2022, the Company and each of its Subsidiaries have implemented physical, technical and administrative safeguards to protect “protected health information” or “PHI” (as defined under HIPAA). Except as has not had, and would not reasonably be expected to have, a Company Material Adverse Effect, since January 1, 2024, neither the Company, its Subsidiaries, nor any of their respective directors, officers or employees have received notice, complaints, or audit requests from any Governmental Authority regarding uses or disclosures of PHI or its alleged failure to comply with HIPAA or any other Healthcare Law applicable to PHI.
(d) The Company and its Subsidiaries have, and for the past five years have maintained, all Permits required and issued by the FDA and comparable local, state, and foreign Governmental Authorities (“Medical Device Permits”) necessary for the conduct of the business by of the Company and its Subsidiaries as currently conducted, except as has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. The Company and its Subsidiaries are not in violation or breach of any of the Medical Device Permits. In the past five years, neither the Company nor any Subsidiary has received notice of any Proceedings pending or, to the Knowledge of the Company, threatened relating to the suspension, revocation or modification of any Medical Device Permit.
(e) Except as set forth on Section 4.22 of the Company Disclosure Schedule, for the past five years, the operations of the Company and its Subsidiaries have been in material compliance with Medical Device Laws. The operations of the Company and its Subsidiaries regarding the design, development, manufacturing, testing, packaging, labeling, storage, handling, distribution, marketing, advertising, import, and export of medical devices have been conducted in material compliance with Applicable Laws, including the requirements of current good manufacturing practices under 21 C.F.R. Part 820, ISO 13485:2016, and applicable comparable local, state, and foreign Applicable Laws. As applicable, the medical device manufacturing establishments are registered, and medical devices are listed, with the FDA and comparable local, state, and foreign Governmental Authorities whenever legally required in the jurisdictions where the devices are designed, manufactured, distributed, and/or sold.
(f) Except as set forth on Section 4.22 of the Company Disclosure Schedule, for the past five years (i) there have been no recalls, field safety corrective actions, corrections, or removals ordered (or, to the Knowledge of the Company, threatened) by the FDA or any comparable Governmental Authority with respect to any products designed, manufactured, processed, marketed, or sold by the Company or its Subsidiaries, (ii) the Company and its Subsidiaries have neither voluntarily nor at the request of any Governmental Authority initiated or participated in any recalls, field safety corrective actions, corrections or removals of any products designed, manufactured, marketed, or sold by the Company or its Subsidiaries, and (iii) to the Knowledge of the Company, no customer of the Company or its Subsidiaries has voluntarily, nor at the request of any Governmental Authority, initiated or participated in any recalls, field safety corrective actions, corrections or removals of products designed, processed, or manufactured by the Company or its Subsidiaries as a direct or indirect result of the services of the Company or any of its Subsidiaries. To the Knowledge of the Company, there are no facts or circumstances reasonably likely to result in a recall, field safety corrective action, correction, or removal of any product designed, manufactured, processed, marketed, or sold by the Company or any of its Subsidiaries.
(g) In the past five years, no product designed, manufactured, processed, marketed or sold by the Company or any of its Subsidiaries has been seized, withdrawn, detained, subject to a suspension, destruction order, safety alert or similar action, and there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, detention, public health notification, safety alert or suspension or termination of manufacturing, testing, marketing, or other activity relating to any such product, or (ii) a change in the labeling of any such product suggesting a compliance issue or risk. No Proceeding in the United States or any other jurisdiction seeking the withdrawal, revocation, suspension, import refusal or import alert, or seizure of any product designed, manufactured, processed, marketed or sold by the Company or any of its Subsidiaries is pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries.
(h) For the past five years, all reports, statements, documents, registrations, filings, and submissions required to be filed by or on behalf of the Company or any of its Subsidiaries with the FDA or any comparable local, state, or foreign Governmental Authority have been filed, properly maintained, amended and supplemented as required by Medical Device Laws, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All such reports and filings were and are complete and truthful and in material compliance with Medical Device Laws when filed or as amended or supplemented, and no deficiencies have been asserted in writing by any Governmental Authority with respect to such reports and filings, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Neither the Company, nor any Subsidiary, officer,
