Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Regulatory
Authority or other governmental entity alleging that the Company is in material violation of any Health Care Laws, including, without limitation, any FDA Form 483, notice of adverse finding, warning letter, untitled letter from the FDA or any other
Regulatory Authority or governmental entity, nor, to the Companys knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (iii) the Company is not a party to any
corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Regulatory Authority or other governmental entity; and (iv) neither the Company nor any of its employees,
officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to an inquiry, investigation, proceeding or other
similar action by a Regulatory Authority or other governmental entity that could reasonably be expected to result in debarment, suspension, or exclusion.
(cc) All Necessary Permits, etc. The Company and its subsidiaries possess all certificates, authorizations and permits issued by
the appropriate federal, state or foreign regulatory authorities necessary to conduct their respective businesses, including, without limitation, from the Regulatory Authorities, and neither the Company nor any of its subsidiaries has received any
notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a Material Adverse Change
on the Company and its subsidiaries, taken as a whole, except as described in the Registration Statement and Prospectus.
(dd)
Compliance with ERISA. Except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Change on the Company and its subsidiaries, taken as a whole, (i) each employee benefit plan, within the meaning of
Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (ERISA), that is sponsored, maintained, administered or contributed to by the Company has been maintained in material compliance with its
terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited to ERISA and the Internal Revenue Code of 1986, as amended (the Code), and (ii) neither the Company nor
any member of its Controlled Group (defined as any trade or business, whether or not incorporated, that would be regarded as a single employer with the Company under Section 414 of the Code) (x) has ever sponsored, maintained,
contributed to or has had any obligation to contribute to, any employee benefit plan that is subject to Title IV of ERISA or any multiemployer plan as defined in Section 3(37) of ERISA or (y) has incurred, or reasonably expects
to incur, any liability under Title IV of ERISA.
(ee) Preparation of the Financial Statements. The financial statements
included or incorporated by reference in each of the Registration Statement and the Prospectus, together with the related notes thereto, comply as to form in all material respects with the applicable accounting requirements of the Securities Act and
present fairly the consolidated financial position of the Company and its subsidiaries as of the dates shown and its results of operations and comprehensive loss, statements of convertible preferred units and convertible preferred stock and
members and stockholders deficit and cash flows for the periods shown, and such financial statements have been prepared in conformity with generally accepted accounting principles in the United States
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