Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 633

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 633
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 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, trials, or data resulting therefrom, which indicate that any Company Product or product candidate cannot be developed, investigated, tested, labeled, manufactured, stored distributed or marketed substantially in the manner presently performed 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. (d)Neither the Company nor, to the Company’s knowledge, any officer, employee or agent of the Company has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither the Company Annex A-23 nor, to the Company’s knowledge, any officer, employee or agent of the Company has been convicted of any crime or engaged in any conduct for which such person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. 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 Governmental Authority except as would not have or would not reasonably be expected to have a Company Material Adverse Effect. Neither the Company nor to the knowledge of the Company, any of its officers or employees, is the subject of any investigation by FDA pursuant to its “ Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities ” policy as stated at 56 Fed. Reg. 46191 (Sept. 10, 1991) (the “ FDA Application Integrity Policy ”) or by any other similar Governmental Authority pursuant to any similar policy. Neither the Company nor, to the Company’s knowledge, any of its officers or employees has as (i) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority; (ii) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority; or (iii) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for