Company: STAA
Filing Date: 2025-08-29
Form Type: PREM14A
Source: 0001193125-25-192889
Chunk: 197

Company: STAAR SURGICAL CO
Filing Date: 2025-08-29
Form: PREM14A
Chunk 197
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 studies or tests.

A-17

(c) Except as would not reasonably be expected to have, individually or in the aggregate, a
Material Adverse Effect, since July 1, 2022, no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statement to a Regulatory Authority, (ii) failed to disclose a material fact required to be
disclosed to a Regulatory Authority, or (iii) to the knowledge of the Company, committed any other act, made any statement or failed to make any statement, that (in any such case) would reasonably be expected to establish a reasonable basis for
any Regulatory Authority to invoke any policy related to fraud or untrue statements (e.g., the FDA’s Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy). Except as would not reasonably be expected to have,
individually or in the aggregate, a Material Adverse Effect, no Acquired Corporation is the subject of any pending, or, to the knowledge of the Company, threatened investigation by a Regulatory Authority with respect to the matters specified in the
foregoing – . Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, since July 1, 2022 to the date of this Agreement, no Acquired Corporation nor,
to the knowledge of the Company, any officers, employees, agents or clinical investigators (acting on behalf of the business of the Acquired Corporation) has been suspended, disqualified, debarred or convicted of any crime by a Regulatory Authority
or, to the knowledge of the Company, engaged in any conduct that would reasonably be expected to result in debarment or exclusion under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or a similar
Legal Requirement.

(d) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect:

(i) each Acquired Corporation and the products manufactured or marketed by or on behalf of such Acquired Corporation have, since
July 1, 2022, been in compliance with all Legal Requirements issued by a Regulatory Authority applicable to the operation of such Acquired Corporation’s business;

(ii) no Acquired Corporation or, to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf
of the Acquired Corporations (but only in their capacity as such) has been subject to any enforcement,