ITS AFFILIATES WITH RESPECT
TO THE BUSINESS HAS BEEN RECALLED, WITHDRAWN, SUSPENDED OR DISCONTINUED (WHETHER
VOLUNTARILY OR OTHERWISE) SINCE 1 JANUARY 2006. NO PROCEEDINGS (WHETHER
COMPLETED OR PENDING) SEEKING THE RECALL, WITHDRAWAL, SUSPENSION OR SEIZURE OF
ANY SUCH PRODUCT OR PRODUCT CANDIDATE OR PRE-MARKET APPROVALS OR MARKETING
AUTHORIZATIONS ARE PENDING, OR TO THE KNOWLEDGE OF SELLER, THREATENED, AGAINST
THE SELLER AND ITS AFFILIATES, NOR HAVE ANY SUCH PROCEEDINGS BEEN PENDING AT ANY
TIME SINCE 1 JANUARY 2006. SELLER, PRIOR TO THE EXECUTION OF THIS AGREEMENT,
HAVE PROVIDED OR MADE AVAILABLE TO PURCHASER ALL CURRENT REPORTS AND ALL
INFORMATION ABOUT ADVERSE DRUG EXPERIENCES AND MEDICAL DEVICE REPORTS IN THE
85
CONFIDENTIAL TREATMENT
[***] Indicates that text has been omitted which is the subject of a
confidential treatment request. This text has been separately filed with the
SEC.
POSSESSION OF THE SELLER AND ITS AFFILIATES (OR TO WHICH SELLER AND ITS
AFFILIATES HAS ACCESS), IN EACH CASE SINCE 1 JANUARY 2006 OBTAINED OR OTHERWISE
RECEIVED BY SELLER AND ITS AFFILIATES FROM ANY SOURCE IN THE UNITED STATES OR
OUTSIDE THE UNITED STATES, INCLUDING INFORMATION DERIVED FROM CLINICAL
INVESTIGATIONS PRIOR TO ANY MARKET AUTHORIZATION APPROVALS, COMMERCIAL MARKETING
EXPERIENCE, POSTMARKETING CLINICAL INVESTIGATIONS, POSTMARKETING
EPIDEMIOLOGICAL/ SURVEILLANCE STUDIES, REPORTS IN THE SCIENTIFIC LITERATURE, AND
UNPUBLISHED SCIENTIFIC PAPERS RELATING TO ANY PRODUCT OR PRODUCT CANDIDATE
MANUFACTURED, TESTED, DISTRIBUTED, HELD AND/OR MARKETED BY THE SELLER OR ITS
AFFILIATES IN RESPECT OF THE BUSINESS OR ANY OF THEIR LICENSORS OR LICENSEES.
9.20.8
TO THE KNOWLEDGE OF SELLER, SINCE 1 JANUARY 2006 NEITHER
SELLER NOR ITS AFFILIATES NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS,
BUSINESS EMPLOYEES OR AGENTS HAS WITH RESPECT TO ANY PRODUCT THAT IS
MANUFACTURED, TESTED, DISTRIBUTED, HELD AND/OR MARKETED BY THE SELLER OR ITS
AFFILIATES IN RESPECT OF THE BUSINESS MADE AN UNTRUE STATEMENT OF A MATERIAL
FACT OR FRAUDULENT STATEMENT TO ANY GOVERNMENTAL AUTHORITY, FAILED TO DISCLOSE A
MATERIAL FACT REQUIRED TO BE DISCLOSED TO ANY GOVERNMENTAL AUTHORITY, OR
COMMITTED AN ACT, MADE A STATEMENT, OR FAILED TO MAKE A STATEMENT THAT, AT THE
TIME SUCH DISCLOSURE WAS MADE, COULD REASONABLY BE EXPECTED TO PROVIDE A BASIS
FOR A GOVERNMENTAL AUTHORITY TO TAKE ANY ACTION OR INITIATE ANY PROCEEDING
PERTAINING TO THE PROVISION OF FRAUDULENT, UNTRUE OR OTHER SIMILARLY
INAPPROPRIATE STATEMENTS OR INFORMATION TO SUCH GOVERNMENTAL AUTHORITY (E.G.,
THE FDA'S POLICY RESPECTING "FRAUD, UNTRUE STATEMENTS OF MATERIAL FACTS,
BRIBERY, AND ILLEGAL GRATUITIES" SET FORTH IN 56 FED. REG. 46191 (10
SEPTEMBER 1991)) OR ANY SIMILAR POLICY OR LAW OUTSIDE THE UNITED STATES.
9.20.9
NEITHER THE SELLER NOR ITS AFFILIATES HAS RECEIVED,
SINCE 1 JANUARY 2006, ANY WRITTEN NOTIFICATION, THAT REMAINS UNRESOLVED, FROM
ANY GOVERNMENT AUTHORITIES INDICATING THAT ANY PRODUCT OF THE BUSINESS IS
UNAPPROVED, MISBRANDED OR ADULTERATED. THE SELLER AND ITS AFFILIATES HAVE
MANUFACTURED, PROCESSED, PACKAGED, LABELED, STORED, SHIPPED AND OTHERWISE
HANDLED ALL PRODUCTS OF THE BUSINESS IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH
ALL APPLICABLE LAWS AND NONE OF SUCH PRODUCTS IS UNAPPROVED, MISBRANDED OR
ADULTERATED.
9.20.10
TO THE KNOWLEDGE OF SELLER, THE THIRD