AS AMENDED (THE "FDCA"), THE PUBLIC HEALTH SERVICE ACT OF
1944, AS AMENDED (THE "PHSA") AND THE REGULATIONS OF THE U.S. FOOD AND DRUG
ADMINISTRATION (THE "FDA") PROMULGATED THEREUNDER) (COLLECTIVELY, "PERMITS"),
AND THE COMPANY HAS NOT RECEIVED ANY NOTICE (ORAL OR WRITTEN) OF PROCEEDINGS
RELATING TO THE REVOCATION OR MODIFICATION OF ANY PERMIT.
THE COMPANY AND ITS
SUBSIDIARIES ARE IN FULL COMPLIANCE WITH ALL LAWS, INCLUDING, BUT NOT LIMITED
TO, LAWS WITH RESPECT TO MANUFACTURING, CLINICAL RESEARCH AND DEVELOPMENT,
SUBMISSION OF APPLICATIONS FOR REVIEW BY GOVERNMENTAL AUTHORITIES, MARKETING,
PROMOTION, AND SALE OF ALL OF THEIR PRODUCTS.
THERE ARE NO PENDING OR, TO THE
KNOWLEDGE OF THE COMPANY, THREATENED ACTIONS OR PROCEEDINGS BY THE FDA, U.S.
DEPARTMENT OF JUSTICE, OR ANY APPLICABLE FOREIGN EQUIVALENT WHICH WOULD PROHIBIT
OR IMPEDE THE SALE OF ANY PRODUCT CURRENTLY IN DEVELOPMENT, UNDER INVESTIGATION,
OR MANUFACTURED OR SOLD BY THE COMPANY OR ANY OF ITS SUBSIDIARIES INTO ANY
MARKET.
THE COMPANY IS IN COMPLIANCE IN ALL MATERIAL RESPECTS UNDER EACH, AND
THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT WILL NOT CAUSE A VIOLATION UNDER
ANY OF SUCH PERMITS.
THE COMPANY IS IN COMPLIANCE IN ALL RESPECTS WITH ALL
MATERIAL PROVISIONS OF THE LAWS AND GOVERNMENTAL RULES AND REGULATIONS
APPLICABLE TO ITS BUSINESSES, PROPERTIES AND ASSETS, AND TO THE PRODUCTS AND
SERVICES UNDER DEVELOPMENT, INVESTIGATION, OR SOLD BY IT, INCLUDING, WITHOUT
LIMITATION, ALL SUCH RULES, LAWS AND REGULATIONS RELATING TO FAIR EMPLOYMENT
PRACTICES AND PUBLIC OR EMPLOYEE SAFETY.
4.15
INSURANCE.
NEITHER THE COMPANY NOR ANY
SUBSIDIARY HAS ANY REASON TO BELIEVE THAT IT WILL NOT BE ABLE TO RENEW ITS
EXISTING INSURANCE COVERAGE AS AND WHEN SUCH COVERAGE EXPIRES OR TO OBTAIN
SIMILAR COVERAGE FROM SIMILAR INSURERS AS MAY BE NECESSARY TO CONTINUE ITS
BUSINESS ON TERMS CONSISTENT WITH THE MARKET FOR THE BUSINESS IN WHICH THE
COMPANY AND ITS SUBSIDIARIES OPERATE.
THERE ARE CURRENTLY NO PROCEEDINGS
PENDING AGAINST THE COMPANY OR ANY SUBSIDIARY UNDER ANY INSURANCE POLICIES
CURRENTLY IN EFFECT AND COVERING THE PROPERTY, BUSINESS OR EMPLOYEES OF THE
COMPANY AND ITS SUBSIDIARY, AND ALL PREMIUMS DUE AND PAYABLE WITH RESPECT TO THE
INSURANCE POLICIES MAINTAINED BY THE COMPANY AND THE SUBSIDIARIES HAVE BEEN PAID
TO DATE.
THE COMPANY AND ITS SUBSIDIARIES HAVE IN FULL FORCE AND EFFECT FIRE-
AND CASUALTY AND SUCH OTHER INSURANCE POLICIES ISSUED BY INSURERS OF RECOGNIZED
FINANCIAL RESPONSIBILITY THAT EXTEND COVERAGE SUFFICIENT IN AMOUNT AS ARE
REASONABLY PRUDENT AND CUSTOMARY IN THE BUSINESS IN WHICH THE COMPANY AND ITS
SUBSIDIARIES ARE ENGAGED (SUBJECT TO REASONABLE DEDUCTIBLES) TO ALLOW IT TO
REPLACE ANY OF ITS PROPERTIES THAT MIGHT BE DAMAGED OR DESTROYED.
NEITHER THE
COMPANY NOR ANY SUBSIDIARY IS IN DEFAULT WITH RESPECT TO ITS OBLIGATIONS UNDER
ANY INSURANCE POLICY MAINTAINED BY IT EXCEPT FOR ANY SUCH DEFAULTS AS WOULD NOT
REASONABLY BE EXPECTED TO HAVE A MATERIAL ADVERSE EFFECT.
4.16
INVESTMENT COMPANY; FIRPTA.
NEITHER THE COMPANY
NOR ANY SUBSIDIARY IS, AN INVESTMENT COMPANY NOR IS EITHER OF THEM AN AFFILIATE
OF AN INVESTMENT COMPANY WITHIN THE MEANING OF THE INVESTMENT COMPANY ACT