PRODUCT INCLUDED IN THE INVENTORY AS OF THE DATE HEREOF
AND THE CLOSING DATE, INCLUDING LOT NUMBERS, SHELF LIFE AND TYPE AND LOCATION
THEREOF.
(D)
NONE OF SELLER, ANY OF ITS AFFILIATES OR ANY PERSON ACTING ON
BEHALF OF SELLER OR ANY OF ITS AFFILIATES HAS SOLD OR DISTRIBUTED THE PRODUCT TO
ANY PERSON, INCLUDING PHYSICIANS.
SECTION 6.10
REGULATORY MATTERS.
(A)
SELLER OWNS, HOLDS OR POSSESSES ALL PERMITS, LICENSES, FRANCHISES,
PRIVILEGES, APPROVALS AND OTHER AUTHORIZATIONS FROM ANY GOVERNMENTAL OR
REGULATORY AUTHORITY WHICH ARE NECESSARY TO ENTITLE IT TO OWN OR LEASE, OPERATE
AND USE THE PURCHASED ASSETS AND TO CARRY ON AND CONDUCT THE BUSINESS AS
CURRENTLY CONDUCTED OR PLANNED TO BE CONDUCTED BY IT (COLLECTIVELY, THE
"PERMITS"). SECTION 6.10(A) OF THE SELLER DISCLOSURE SCHEDULE SETS FORTH A LIST
AND BRIEF DESCRIPTION OF EACH PERMIT. SELLER IS NOT IN VIOLATION OF OR DEFAULT
IN ANY MATERIAL RESPECT UNDER ANY PERMIT. SELLER HAS FULFILLED AND PERFORMED IN
ALL MATERIAL RESPECTS ITS OBLIGATIONS UNDER EACH PERMIT, AND, TO THE KNOWLEDGE
OF SELLER, NO EVENT HAS OCCURRED OR CONDITION OR STATE OF FACTS EXISTS WHICH
CONSTITUTES OR, AFTER NOTICE OR LAPSE OF TIME OR BOTH, WOULD CONSTITUTE A BREACH
OF OR DEFAULT UNDER ANY SUCH PERMIT OR WHICH PERMITS OR, AFTER NOTICE OR LAPSE
OF TIME OR BOTH, WOULD PERMIT REVOCATION OR TERMINATION OF ANY SUCH PERMIT. TO
THE KNOWLEDGE OF SELLERS, NO NOTICE OF CANCELLATION, OF DEFAULT OR OF ANY
DISPUTE CONCERNING ANY PERMIT, OR OF ANY EVENT, CONDITION OR
**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.
25
STATE OF FACTS DESCRIBED IN THE PRECEDING SENTENCE, HAS BEEN RECEIVED BY SELLER.
EACH OF THE PERMITS IS VALID, SUBSISTING AND IN FULL FORCE AND EFFECT AND MAY BE
ASSIGNED AND TRANSFERRED TO BUYER IN ACCORDANCE WITH THIS AGREEMENT AND WILL
CONTINUE IN FULL FORCE AND EFFECT IMMEDIATELY AFTER THE CLOSING, IN EACH CASE
WITHOUT (X) THE OCCURRENCE OF ANY BREACH, DEFAULT OR FORFEITURE OF RIGHTS
THEREUNDER, OR (Y) THE CONSENT, APPROVAL OR ACT OF, OR THE MAKING OF ANY FILING
WITH, AND GOVERNMENTAL OR REGULATORY AUTHORITY.
(B)
COMPLETE AND CORRECT COPIES OF EACH SUBMISSION OF SELLER TO THE
FDA WITH RESPECT TO THE PRODUCT, AND ALL AMENDMENTS AND SUPPLEMENTS THERETO,
INCLUDING ALL RELATED PRE-CLINICAL AND CLINICAL DATA, HAVE HERETOFORE BEEN
PROVIDED TO BUYER BY SELLER. COMPLETE AND CORRECT COPIES OF ALL CORRESPONDENCE
RECEIVED BY SELLER FROM THE FDA WITH RESPECT TO THE PRODUCT AND SELLER'S
RESPONSES THERETO HAVE HERETOFORE BEEN PROVIDED TO BUYER BY SELLER. COMPLETE AND
CORRECT COPIES OF ALL COMPLAINT INFORMATION, ADVERSE EVENT INFORMATION AND
SAFETY INFORMATION RELATING TO THE PRODUCT AND THE REGULATORY APPROVALS HAVE
HERETOFORE BEEN PROVIDED TO BUYER.
(C)
THE PRODUCT HAS BEEN AND IS BEING MANUFACTURED, DISTRIBUTED AND
MARKETED IN COMPLIANCE WITH ALL APPLICABLE REQUIREMENTS UNDER THE FDCA AND ANY
SIMILAR LAW, INCLUDING