(xxii) Compliance with Applicable Laws and Regulations. Except as would not reasonably be expected to have a Material Adverse Effect or as described in the Registration Statement and Prospectus, as applicable, the Company and each of its Subsidiaries and, to the Companys knowledge, the directors, officers, employees, and agents (while acting in such capacity) of the Company and each of its Subsidiaries are, and at all times have been, in compliance with, all health care laws and regulations applicable to the Company or its Subsidiaries, including all such health care laws and regulations pertaining to development and testing of health care products or medical devices, fraud and abuse, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by health care laws), quality, safety, privacy, security, licensure, ownership, manufacturing, packaging, labeling, processing, use, distribution, storage, import, export, advertising, promotion, marketing or disposal of health care products or medical devices (collectively, the Applicable Laws); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (Authorizations); (iii) possess all Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.
(xxiii) No Safety Notices. Except as would not reasonably be expected to have a Material Adverse Effect or as disclosed in the Registration Statement and the Prospectus, there have been no recalls, field notifications, corrections or removals, market withdrawals or replacements, warnings, dear doctor letters, investigator notices, safety alerts, safety communications or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the products of the Company or any of its Subsidiaries (Safety Notices). To the Companys knowledge, there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products of the Company or any of its Subsidiaries, (ii) a material change in labeling of any of the products of the Company or any of its Subsidiaries, or (iii) a termination or suspension of marketing or testing of any of the products of the Company or any of its Subsidiaries, except, in each case, as would not reasonably be expected to have a Material Adverse Effect.