Company: STAA
Filing Date: 2025-08-05
Form Type: DEFA14A
Source: 0001193125-25-173098
Chunk: 38

Company: STAAR SURGICAL CO
Filing Date: 2025-08-05
Form: DEFA14A
Chunk 38
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Material Adverse Effect, all preclinical and clinical investigations conducted by, or on behalf of, the Acquired Corporations since July 1, 2022 have been and are being conducted in material compliance with all applicable Legal Requirements,
including Good Clinical Practices requirements in each relevant jurisdiction, and including Legal Requirements restricting the use and disclosure of individually identifiable health information. Since July 1, 2022, no Acquired Corporation has
received any material written notice from a Regulatory Authority with respect to any ongoing clinical or preclinical investigations requiring the termination, suspension or material modification of such studies or tests.

(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