4.26 Regulatory Matters.
(a) (i) Each Group Member has, and it and its Products are in conformance in all material respects with, all Regulatory Required Permits required to conduct its respective businesses as now conducted; (ii) to the knowledge of Holdings and the Borrower, neither the FDA nor other Governmental Authority has provided notice of or is considering limiting, suspending, revoking or terminating such Regulatory Required Permits; (iii) the Group Members have fulfilled and performed, in all material respects, their obligations under each material Regulatory Required Permit, and, to the knowledge of each Group Member, no event has occurred or condition or state of facts exists which would constitute a breach or default, or would cause revocation, limitation, suspension, or termination of any such Regulatory Required Permit, except (x) with respect to Core Business Segments, in each of cases (i), (ii) and (iii) to the extent such Regulatory Required Permit are not material to the business of the Group Members, and (y) other than with respect to Core Business Segments, in each of cases (i), (ii) and (iii), to the extent it would not reasonably be expect to have a Material Adverse Effect.
(b) All Products that are subject to Health Care Laws, to the knowledge of each Group Member, have been and are being researched, designed, developed, tested, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance in all material respects with applicable Health Care Laws or any other Applicable Law, including, without limitation, the Applicable Laws related to clinical and non-clinical testing, product approval or clearance, current good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and listing, and medical device and other post-market reporting, and all other importation and distribution requirements, except as it would not be reasonably expected to have a Material Adverse Effect.
(c) Except as it would not be reasonably expected to have a Material Adverse Effect or as it has been publicly disclosed, (i) with respect to any Product, the Group Members have received all Regulatory Required Permits required in connection with the design, testing, manufacture, processing, assembly, packaging, labeling, marketing, distribution, commercialization, import, export, or sale of such Product as currently being conducted by or on behalf of such Group Member; and (ii) no Group Member has been restrained in its ability to manufacture, process, distribute, supply, import, export, market, or sell any of its Products.
(d) As of the Closing Date, no Group Member is undergoing any inspection related to Regulatory Required Permits, except as set forth on Schedule 4.26.
(e) To the knowledge of each Group Member, no Group Member nor any of their respective officers, directors or employees has (A) made any untrue statement of material fact, fraudulent statement, or material omission to the FDA or any other Governmental Authority or in any documents or records required to be maintained under the Applicable Laws; (B) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority; or (C) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other Governmental Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, as set forth in 56 Fed. Reg. 46191 (September 10, 1991); or (D) been investigated by FDA or any other Governmental Authority, including but not limited to the Office of the Inspector General for the Department of Health and Human Services, or the Department of Justice, for data or healthcare program fraud. To the knowledge of each Group Member, no Group Member, nor any of their respective officers, directors, employees, or, to their knowledge, contractors, have made or offered any payment, gratuity, or other thing of value that is prohibited by any Applicable Law to personnel of the FDA or any other Governmental Authority.