employees and agents solely with respect to the exercise of each of their respective duties on behalf of the Borrower or its Subsidiaries are in compliance with all applicable Health Care Laws,
and (2) neither the Borrower nor any of its Subsidiaries has received written notice of any pending or, to the knowledge of the Borrower or any Subsidiary, threatened claim, suit, proceeding, hearing, enforcement, audit, formal inquiry, qui tam
action, appeal, professional disciplinary or regulatory proceedings, inspection, investigation, seizure, shutdown, field action, recall, untitled letter or warning letter, notice of suspension or cancellation of a drug establishment license, medical
device establishment registration or other license or clinical trial, U.S. Food and Drug Administration and any successor agency thereto (FDA) Form 483, clinical hold, arbitration or other similar correspondence or action from the
DEA, the U.S. Department of Health and Human Services and any successor agency thereto, the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Customs and Border Protection, and any successor agency to any of the
above or any applicable Governmental Authority with jurisdiction over the safety, efficacy, research, design, development, manufacture, ownership, testing, storage, transportation, distribution, supply, packaging, processing, use, marketing,
labeling, promotion, advertising, holding, import or export, disposal or sale or offer for sale of any product, service, operation or activity of the Loan Parties, including equivalent foreign and state Governmental Authorities (each a
Regulatory Authority), alleging that any such service, operation or activity of the Borrower or any of its Subsidiaries, or any of such products, is in violation of any applicable Health Care Law or which, if resolved in a manner
adverse to the Borrower or its Subsidiaries, would be reasonably likely to result in the imposition of any penalties under a Health Care Law, or restrict their ability to conduct their business as currently conducted in under Health Care Laws;
(ii) Except as would not reasonably be expected to have a Material Adverse Effect on the Borrower and its Subsidiaries,
none of the Borrower, its Subsidiaries, nor to the knowledge of the Borrower, any of their respective officers, directors, employees or agents with respect to the exercise of each of their respective duties on behalf of the Borrower or its
Subsidiaries have engaged in any activities which are reasonably likely to result in civil penalties imposed on or mandatory or permissive exclusion or ineligibility, debarment, or suspension of the Borrower or any Subsidiary from participation in
any Federal Health Care Program or similar program outside the United States, as applicable;
(iii) Except as would
not reasonably be expected to have a Material Adverse Effect on the Borrower and its Subsidiaries, all products researched, formulated, designed, developed, manufactured, owned, tested, distributed, supplied, packaged, processed, used, held, stored,
transported, sold, offered for sale, imported, exported, marketed, labeled, advertised, promoted or disposed by the Borrower or any of its Subsidiaries, as applicable, are being researched, formulated, designed, developed, manufactured, owned,
tested, distributed, supplied, packaged, processed, held, stored, transported, sold, offered for sale, imported, exported, marketed, labeled, advertised, promoted or disposed in compliance with all applicable Health Care Laws; and
(iv) Except as would not reasonably be expected to have a Material Adverse Effect on the Borrower and its Subsidiaries
(1) the Borrower and each of its Subsidiaries possesses and is operating in compliance with, all licenses, franchises, permits, clearances, registrations, approvals, variances, exemptions, and other authorizations from Regulatory Authorities
that are necessary under any applicable Health Care Law to conduct its business as currently conducted (collectively, the Health Care Permits), (2) all such Health Care Permits are in full force and effect, (3) to the
Knowledge of the Borrower, each of the Subsidiaries has made all declarations and filings with the appropriate federal, state, local or foreign Governmental Authorities or Regulatory Authorities that are necessary for the Health Care Permits, and
(4) no Subsidiary has received written notice of any revocation, material modification, suspension or termination of any Health Care Permit or to the knowledge of the Borrower, do facts or circumstances exist that would reasonably be expected
to cause any such Health Care Permit to not be renewed in the ordinary course.
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