vi) the Clinical Laboratories Improvement Act of 1967, as amended);
vii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign
laws or regulatory bodies; and
viii) all other local, state, federal, national, supranational and foreign laws,
relating to the regulation of the Company and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under
development, manufactured or distributed by the Company; (clauses (i) through (viii), collectively, Health Care Laws).
(ll) Clinical Studies. (i) The studies conducted by the Company in support of the validity or utility of the
Companys NeXT Platform and other current and potential offerings, were, and if still pending are, being conducted in all material respects in accordance with standard medical and experimental protocols, procedures and controls pursuant to
accepted professional scientific research standards and procedures; (ii) the descriptions of the results of such studies contained in the Registration Statement and the Prospectus are accurate and complete in all material respects; and
(iii) the Company has no knowledge of any other studies not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration
Statement and the Prospectus.
(mm) Healthcare Regulation. (i) Except as would not, individually or in
the aggregate, reasonably be expected to have a Material Adverse Effect on the Company and its Subsidiaries, taken as a whole, the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records,
claims, submissions and supplements or amendments as required by any Health Care Laws, and, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not
misleading on the date filed (or were corrected or supplemented by a subsequent submission); (ii) the 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, other governmental entity or third party alleging that any Company or product operation or activity is in violation of any Health Care Laws, including, without limitation, any FDA Form 483,
notice of adverse finding, warning letter, untitled letter or other correspondence or notice 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.
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