GOVERNMENTAL OR REGULATORY AUTHORITY TO INVOKE ITS POLICY RESPECTING "FRAUD,
UNTRUE STATEMENTS OF MATERIAL FACTS, BRIBERY, AND ILLEGAL GRATUITIES" SET FORTH
IN 56 FED. REG. 46191 (SEPTEMBER 10, 1991) OR ANY SIMILAR POLICY AND, TO THE
KNOWLEDGE OF SELLER, NEITHER SELLER NOR ANY OF ITS OFFICERS, EMPLOYEES OR AGENTS
IS THE SUBJECT, OFFICIALLY OR OTHERWISE, OF ANY PENDING OR THREATENED
INVESTIGATION BY ANY GOVERNMENTAL OR REGULATORY AUTHORITY UNDER SUCH POLICY OR
UNDER THE FEDERAL ANTI-KICKBACK STATUTE OR THE CIVIL FALSE CLAIMS ACT OR ANY
REGULATIONS PROMULGATED THEREUNDER. NEITHER SELLER NOR ANY OF ITS OFFICERS,
EMPLOYEES OR AGENTS HAS BEEN CONVICTED OF ANY CRIME OR ENGAGED IN ANY CONDUCT
WITH RESPECT TO THE PRODUCT FOR WHICH DEBARMENT IS MANDATED BY 21 U.S.C. SEC.
335A(A) OR ANY SIMILAR LAW OR AUTHORIZED BY 21 U.S.C. SEC. 335A(B) OR ANY
SIMILAR LAW.
(H)
TO THE KNOWLEDGE OF SELLER, ALL PRE-CLINICAL AND CLINICAL
INVESTIGATIONS CONDUCTED OR SPONSORED BY IT WITH RESPECT TO THE PRODUCT HAVE
BEEN AND ARE BEING CONDUCTED IN COMPLIANCE WITH ALL RECOMMENDATIONS OF THE FDA
AND ALL APPLICABLE LAWS, INCLUDING THOSE WITH RESPECT TO GOOD LABORATORY
PRACTICES, INVESTIGATIONAL NEW DRUG REQUIREMENTS, GOOD CLINICAL PRACTICE
REQUIREMENTS (INCLUDING INFORMED CONSENT AND INSTITUTIONAL REVIEW BOARDS
DESIGNED TO ENSURE THE PROTECTION OF THE RIGHTS AND WELFARE OF HUMAN SUBJECTS),
AND FEDERAL AND STATE LAWS RESTRICTING THE USE AND DISCLOSURE OF INDIVIDUALLY
IDENTIFIABLE HEALTH INFORMATION.
(I)
TO THE KNOWLEDGE OF SELLER, NO GOVERNMENTAL OR REGULATORY
AUTHORITY IS CONSIDERING ISSUING ANY "TALK PAPER" OR OTHER PUBLIC STATEMENT,
PURSUANT TO 21 U.S.C. SEC. 375 OR OTHERWISE, QUESTIONING THE SAFETY,
EFFECTIVENESS OR RISK-BENEFIT RATIO OF THE PRODUCT, AND NO GOVERNMENTAL OR
REGULATORY AUTHORITY IS CONSIDERING REQUESTING OR DIRECTING THAT THE APPROVED
LABELING FOR THE PRODUCT BE REVISED TO INCLUDE ADDITIONAL OR STRENGTHENED
WARNING OR OTHER RISK INFORMATION.
SECTION 6.11
TITLE; SUFFICIENCY OF ASSETS.
(A)
SELLER HAS GOOD AND MARKETABLE TITLE TO ALL OF THE PURCHASED
ASSETS, FREE AND CLEAR OF ANY ENCUMBRANCE, OTHER THAN PERMITTED ENCUMBRANCES.
UPON DELIVERY TO BUYER OF THE ASSIGNMENT AND ASSUMPTION AGREEMENT AND OTHER
INSTRUMENTS OF TRANSFER CONTEMPLATED BY SECTION 5.02(A), SELLER WILL THEREBY
TRANSFER TO BUYER GOOD AND MARKETABLE TITLE TO ALL OF THE PURCHASED ASSETS, FREE
AND CLEAR OF ALL ENCUMBRANCES, OTHER THAN PERMITTED ENCUMBRANCES.
**Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
27
(b)
Except as set forth in Section 6.11(b) of the Seller Disclosure
Schedule, the Purchased Assets collectively include all the assets used in the
Business and all of the assets necessary to conduct the Business as currently
conducted or planned to be conducted.
SECTION 6.12
BROKERS.
Seller has not retained any broker, finder, investment banker or financial
advisor in connection with the transactions contemplated hereunder. Buyer has
no, and will have no, obligation to pay any brokers, finders, investment
bankers, financial advisors or similar fees in connection