Intellectual Property. There is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim by others (x) challenging the Companys rights in or to any
Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (y) challenging the validity or scope of any Intellectual Property that is (I) owned by the
Company or the Subsidiary or (II) exclusively licensed to the Company or the Subsidiary, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (z) asserting that the
Company or the Subsidiary infringes or otherwise violates, or would, upon the commercialization of any product or service described in the Registration Statement and the Prospectus as under development, infringe or violate, any patent, trademark,
trade name, service name, copyright, trade secret or other proprietary rights of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim. The Company is in compliance with
the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company, and all such agreements are in full force and effect, except where the failure so to comply or for such agreements to be in full force and effect
would not, individually or in the aggregate, result in a Material Adverse Effect.
(oo) Except as would not, individually or in the
aggregate, result in a Material Adverse Effect, the Company: (i) is and at all times has been in compliance with all statutes, rules and regulations of the FDA and other comparable Governmental Entities applicable to 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
(Applicable Laws); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any Governmental Entity alleging or asserting
noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (Authorizations);
(iii) possesses all Authorizations and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) has not received notice of any claim, action, suit, proceeding,
hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and, to the
Companys knowledge, neither the FDA nor any Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that the FDA or any Governmental
Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and, to the Companys knowledge, neither the FDA nor any Governmental Entity is considering such action; and (vi) has filed,
obtained, maintained or submitted all 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 correct on the date filed (or were corrected or supplemented by a subsequent submission).
(pp) The Company and the Subsidiary have operated and currently are in compliance with all applicable health care laws, rules and regulations
(except where such failure to operate or non-compliance would not, individually or in the aggregate, result in a Material Adverse Effect), including, without limitation, (i) the Federal, Food, Drug and
Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) all applicable federal, state, local and all applicable foreign healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims
Law (18 U.S.C. § 287), all criminal laws relating to healthcare fraud and abuse, including but not limited to 42 U.S.C. Section 1320a-7b(a), the exclusion laws (42 U.S.C. § 1320a-7), and the civil
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