TO WHICH IT
IS A PARTY THERETO OR TO CONSUMMATE THE TRANSACTIONS CONTEMPLATED THEREBY.
(III)
EACH OF THE LOAN DOCUMENTS TO WHICH ANY LOAN PARTY IS A PARTY HAS BEEN
DULY EXECUTED AND DELIVERED BY SUCH LOAN PARTY AND CONSTITUTES THE LEGAL, VALID
AND BINDING OBLIGATION OF SUCH LOAN PARTY, ENFORCEABLE AGAINST SUCH LOAN PARTY
IN ACCORDANCE WITH ITS TERMS, EXCEPT AS SUCH ENFORCEABILITY MAY BE LIMITED BY
(I) BANKRUPTCY, INSOLVENCY, REORGANIZATION OR OTHER SIMILAR LAWS AFFECTING THE
ENFORCEMENT OF CREDITORS' RIGHTS GENERALLY AND (II) GENERAL PRINCIPLES OF EQUITY
RELATING TO ENFORCEABILITY (REGARDLESS OF WHETHER SUCH ENFORCEABILITY IS
CONSIDERED IN A PROCEEDING IN EQUITY OR AT LAW).
(c)
Ownership.
Section 6.01(C) of the Disclosure Letter sets forth
the ownership of the Borrower's
Subsidiaries as of the date hereof and
separately indicates each Subsidiary that is required to be a Guarantor as of
the Closing Date.
Each Loan Party has delivered to the Administrative Agent
true and complete copies of the Governing Documents for such Loan Party in
effect as of the date hereof.
44
(d)
No Conflict.
The execution, delivery and performance by each Loan
Party of each Loan Document to which it is a party and the consummation of the
transactions contemplated thereby do not and will not (i) conflict with the
Governing Documents of such Loan Party, (ii) violate any Requirements of Law
(including Regulation U) or any material Contractual Obligation of such Loan
Party, or (iii) result in or require the creation or imposition of any Lien
whatsoever upon any of the property or assets of such Loan Party.
(e)
Compliance with Laws; Permits.
(I)
EXCEPT AS SET FORTH IN THE DISCLOSURE LETTER OR AS WOULD NOT HAVE,
EITHER INDIVIDUALLY OR IN THE AGGREGATE, A MATERIAL ADVERSE EFFECT, THE
OPERATIONS AND ASSETS OF THE LOAN PARTIES AND EACH OF THEIR SUBSIDIARIES ARE IN
COMPLIANCE WITH ALL LAWS APPLICABLE TO THE LOANS PARTIES AND THEIR SUBSIDIARIES,
INCLUDING WITHOUT LIMITATION (I) THE LAWS ENFORCED AND REGULATIONS ISSUED BY THE
DEA, THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND ITS CONSTITUENT AGENCIES,
THE FDA, THE CENTERS FOR MEDICARE & MEDICAID SERVICES, AND OFFICE OF INSPECTOR
GENERAL, (INCLUDING, WITHOUT LIMITATION, THE FEDERAL FOOD DRUG AND COSMETIC ACT
(21 U.S.C. § 321 ET SEQ.), THE CONTROLLED SUBSTANCES ACT (21 U.S.C. § 801 ET
SEQ.), THE FEDERAL ANTI-KICKBACK STATUTE (42 U.S.C. § 1320A-7B(B)), THE STARK
LAW (42 U.S.C. § 1395NN), THE ADMINISTRATIVE SIMPLIFICATION PROVISIONS OF THE
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (42 U.S.C. § 1320D
ET SEQ.), THE EXCLUSION LAWS (42 U.S.C. § 1320A-7), THE REGULATIONS PROMULGATED
PURSUANT TO THE FOREGOING LAWS, AND THE FEDERAL ACQUISITION REGULATIONS (48
C.F.R. PARTS 1-53)), (II) THE DRUG PRICE REPORTING REQUIREMENTS OF TITLES XVIII
AND XIX OF THE SOCIAL SECURITY ACT, (III) THE LAWS PRECLUDING OFF-LABEL
MARKETING OF DRUGS, AND (IV) COMPARABLE STATE LAWS.
NEITHER THE LOAN PARTIES
NOR ANY OF THEIR SUBSIDIARIES IS EXCLUDED OR DEBARRED UNDER THE GENERIC DRUG
ENFORCEMENT ACT OF 1992 OR ANY GOVERNMENT HEALTH CARE PROGRAM, INCLUDING,
WITHOUT