regulatory bodies; (vi) any rules and regulations promulgated pursuant to the statutes listed herein, and any other applicable federal, state or local health care laws; and (vii) the applicable directives promulgated pursuant to such Health Care Laws and any applicable state or foreign counterpart thereof, each as amended from time to time. Neither the Company nor its subsidiaries nor, to the knowledge of the Company, any agent has 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, service, operation or activity is in material violation of any Health Care Laws, and the Company has no knowledge that any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its subsidiaries nor, to the knowledge of the Company, any agent is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor its subsidiaries nor their employees, officers, directors, or, to the Company’s knowledge, agents, has been excluded, suspended, debarred or disqualified from participation in any governmental health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in any such exclusion, suspension, debarment or disqualification.
(aa) Regulatory Filings. The Company and its subsidiaries and, to the knowledge of the Company, its agents, have filed, maintained or submitted all material reports, documents, declarations, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Applicable Laws, Authorizations or Health Care Laws, as applicable, and all such material reports, documents, declarations, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission).
(bb) No Undisclosed Relationships. No relationship, direct or indirect, exists between or among the Company or any of its subsidiaries, on the one hand, and the directors, officers, stockholders, customers, suppliers or other affiliates of the Company or any of its subsidiaries, on the other, that is required by the Securities Act to be described in each of the Registration Statement and the Prospectus and that is not so described in such documents and in the Pricing Disclosure Package.
(cc) Investment Company Act. The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, will not be required to register as an “investment company” or an entity “controlled” by an “investment company” within the meaning of the Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder.