Company: STAA
Filing Date: 2025-09-16
Form Type: DEFM14A
Source: 0001193125-25-204396
Chunk: 196

Company: STAAR SURGICAL CO
Filing Date: 2025-09-16
Form: DEFM14A
Chunk 196
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 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, regulatory or administrative proceedings against or affecting such Acquired Corporation or such third party initiated by a Regulatory Authority
and no such enforcement, regulatory or administrative proceeding has been threatened in writing; and

(iii) no Acquired Corporation or,
to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf of any Acquired Corporation (but only in their capacity as such) is party to or has any ongoing obligations pursuant to or under any
corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body.

(e) Except as would not reasonably be expected to be material to the Acquired Corporations, taken as a whole, since July 1, 2022, (i) the
products manufactured or marketed by or on behalf of the Acquired Corporations have complied in all material respects with all applicable Legal Requirements, including GMP, and (ii) the promotional materials and claims made by the Acquired
Corporations for the products manufactured or marketed by or on behalf of the Acquired Corporations have complied with all applicable Legal Requirements.

(f) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, since July 1, 2022,
(i) there have been no product recalls conducted by the Acquired Corporations, no product recalls of product manufactured by or on behalf of the Acquired Corporations, and no written requests from any Governmental Body requiring any Acquired
Corporation to cease manufacturing, marketing, distributing or selling any products of the Acquired Corporations, (ii) no Regulatory Authority has initiated an injunction, seizure, or import or export prohibition against any Acquired
Corporation, any product manufactured or marketed by or on behalf of any Acquired Corporation, or any third-party establishment that manufactures or tests product on behalf of any Acquired Corporation (but only in their capacity as such), and
(iii) no Acquired Corporation has received any written notice of adverse observational inspections or other written warning after inspection of a manufacturing facility similar to an FDA Form 483 from a