ACTION RELATING TO THE ALLEGED LACK OF
SAFETY OR EFFICACY OF ANY PRODUCT OR ANY ALLEGED PRODUCT DEFECT OR VIOLATION
AND, TO THE COMPANY'S KNOWLEDGE, NO THIRD PARTY HAS INITIATED, CONDUCTED OR
INTENDS TO INITIATE OR CONDUCT SUCH NOTICE OR ACTION. NEITHER THE COMPANY NOR,
TO THE COMPANY'S KNOWLEDGE, ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS
HAS BEEN CONVICTED OF ANY CRIME UNDER ANY APPLICABLE LAWS OR HAS BEEN THE
SUBJECT OF AN FDA DEBARMENT PROCEEDING. THE COMPANY HAS NOT BEEN OR IS NOW
SUBJECT TO FDA'S APPLICATION INTEGRITY POLICY. TO THE COMPANY'S KNOWLEDGE,
NEITHER THE COMPANY, NOR ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS,
HAS MADE, OR CAUSED THE MAKING OF, ANY FALSE STATEMENTS ON, OR MATERIAL
OMISSIONS FROM, ANY OTHER RECORDS OR DOCUMENTATION PREPARED OR MAINTAINED TO
COMPLY WITH THE REQUIREMENTS OF THE FDA OR ANY OTHER GOVERNMENTAL ENTITY.
NEITHER THE COMPANY NOR, TO THE COMPANY'S KNOWLEDGE, ANY OF ITS DIRECTORS,
OFFICERS, EMPLOYEES OR AGENTS, HAVE WITH RESPECT TO EACH OF THE FOLLOWING
STATUTES, OR REGULATIONS PROMULGATED THERETO, AS APPLICABLE: (I) ENGAGED IN
ACTIVITIES UNDER 42 U.S.C. §§ 1320A-7B OR 1395NN; (II) KNOWINGLY ENGAGED IN ANY
ACTIVITIES UNDER 42 U.S.C. § 1320A-7B OR THE FEDERAL FALSE CLAIMS ACT, 31 U.S.C.
§ 3729; OR (III) KNOWINGLY AND WILLFULLY ENGAGED IN ANY ACTIVITIES UNDER 42
U.S.C.§ 1320A-7B, WHICH ARE PROHIBITED, CAUSE FOR CIVIL PENALTIES, OR MANDATORY
OR PERMISSIVE EXCLUSION FROM MEDICARE, MEDICAID, OR ANY OTHER STATE HEALTH CARE
PROGRAM OR FEDERAL HEALTH CARE PROGRAM.
9
N.
NO DEFAULTS; VIOLATIONS. NO MATERIAL DEFAULT EXISTS IN THE
DUE PERFORMANCE AND OBSERVANCE OF ANY TERM, COVENANT OR CONDITION OF ANY
MATERIAL LICENSE, CONTRACT, INDENTURE, MORTGAGE, DEED OF TRUST, NOTE, LOAN OR
CREDIT AGREEMENT, OR ANY OTHER AGREEMENT OR INSTRUMENT EVIDENCING AN OBLIGATION
FOR BORROWED MONEY, OR ANY OTHER MATERIAL AGREEMENT OR INSTRUMENT TO WHICH THE
COMPANY IS A PARTY OR BY WHICH THE COMPANY MAY BE BOUND OR TO WHICH ANY OF THE
PROPERTIES OR ASSETS OF THE COMPANY IS SUBJECT. THE COMPANY IS NOT (I) IN
VIOLATION OF ANY TERM OR PROVISION OF ITS CHARTER OR BYLAWS, OR (II) IN
VIOLATION OF ANY FRANCHISE, LICENSE, PERMIT, APPLICABLE LAW, RULE, REGULATION,
JUDGMENT OR DECREE OF ANY GOVERNMENTAL ENTITY APPLICABLE TO THE COMPANY.
O.
CORPORATE POWER; LICENSES; CONSENTS.
I.
EXCEPT AS DESCRIBED IN THE REGISTRATION STATEMENT, THE
DISCLOSURE PACKAGE AND THE PROSPECTUS, THE COMPANY HAS ALL REQUISITE CORPORATE
POWER AND AUTHORITY, AND, EXCEPT AS WOULD NOT REASONABLY BE EXCEPTED TO RESULT
IN A MATERIAL ADVERSE CHANGE, HAS ALL NECESSARY AUTHORIZATIONS, APPROVALS,
ORDERS, LICENSES, CERTIFICATES AND PERMITS OF AND FROM ALL GOVERNMENTAL
REGULATORY OFFICIALS AND BODIES THAT IT NEEDS AS OF THE DATE HEREOF TO CONDUCT
ITS BUSINESS PURPOSE AS DESCRIBED IN THE REGISTRATION STATEMENT, THE DISCLOSURE
PACKAGE AND THE PROSPECTUS.
II.
THE COMPANY HAS ALL CORPORATE POWER AND AUTHORITY TO
ENTER INTO THIS AGREEMENT AND TO CARRY OUT THE PROVISIONS AND CONDITIONS HEREOF,
AND ALL CONSENTS, AUTHORIZATIONS, APPROVALS AND ORDERS REQUIRED IN CONNECTION
THEREWITH HAVE BEEN OBTAINED. NO CONSENT, AUTHORIZATION OR