(xxxv) Regulatory Filings. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, (i) neither the Rani Parties nor their subsidiaries has failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission or failed to obtain any required approval or authorization with respect to the product candidates of the Rani Parties or their subsidiaries that are described or referred to in the Registration Statement, General Disclosure Package and the Prospectus; (ii) all such filings, declarations, listings, registrations, reports or submissions, as applicable, were in compliance with applicable laws when filed; and (iii) no deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions.
(xxxvi) Privacy Laws. The Rani Parties and their subsidiaries are, and at all times since April 1, 2018 have been, in compliance with all applicable data privacy and security laws and regulations, including, without limitation, to the extent applicable, the HIPAA, as amended by the HITECH Act (collectively, Privacy Laws), except where such non-compliance would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. Except as would not, individually or the aggregate, reasonably be expected to have a Material Adverse Effect, none of the Rani Parties nor any of their subsidiaries, (i) has at any time since April 1, 2018 received written notice of any actual or potential liability under, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement by a governmental or regulatory authority that imposes any obligation or liability under any Privacy Law.
(xxxvii) Compliance with Health Care Laws. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Rani Parties and their subsidiaries are, and at all times have been, in compliance with all Health Care Laws. For purposes of this Agreement, Health Care Laws means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable U.S. federal, state, local and non-U.S. health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the HITECH Act; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable U.S. federal, state, local or non-U.S. laws or regulatory bodies; (vi) all other local, state, U.S. federal, national, supranational and non-U.S. health care laws relating to the regulation of the Rani Parties or their subsidiaries, and (vii) the regulations promulgated pursuant to such statutes, and any state or non-U.S. counterpart thereof. None of the Rani Parties nor any of their subsidiaries has received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or 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