Company: PFSA
Filing Date: 2025-04-03
Form Type: S-4/A
Source: 0001213900-25-028544
Chunk: 623

Company: Profusa, Inc.
Filing Date: 2025-04-03
Form: S-4/A
Chunk 623
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 of the Company, threatened in writing. The Company is not in conflict with, or in default, breach or violation of, (a) any Law applicable to the Company or by which any property or asset of the Company is bound or affected, or (b) any Material Contract or Company Permit, except, in each case, for any such conflicts, defaults, breaches or violations that would not have or would not reasonably be expected to have a Company Material Adverse Effect. This Section 4.06 shall not apply to Tax matters. (b)The business of the Company, and each Company Product that is or has been developed or tested by or on behalf of the Company, is in compliance with all applicable Laws, including (ii) all Laws governing patient informed consent; (ii) federal or state criminal or civil fraud and abuse Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), Stark Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), and Data Privacy/Security Laws), and (iii) all comparable state Laws, including state licensing, disclosure and reporting Laws, and all regulations promulgated thereunder, in each case, except as would not have or would not reasonably be expected to have a Company Material Adverse Effect. The Company has not, since the Formation Date, received any written notice of any pending or threatened Action against it alleging any failure to comply with any Law except as would not have or would not reasonably be expected to have a Company Material Adverse Effect. All preclinical studies conducted or sponsored by the Company and intended to be referenced in, or submitted to a Governmental Authority to support, a Product regulatory approval or clearance are being conducted in compliance with all protocols, and applicable Laws except as would not have or would not reasonably be expected to have a Company Material Adverse Effect. The Company has not received any notices or correspondence from the FDA or any other Governmental Authority or any Institutional Review Board or comparable authority threatening to commence or requiring the termination, suspension or material modification of any studies, tests or preclinical development conducted by or on behalf of the Company, except as would not have or would not reasonably be expected to have a Company Material Adverse Effect. This Section 4.06(b) shall not apply to Tax matters. (c)To the Company’s knowledge, no Governmental Authority has identified any facts, studies, tests, development,