the FDA or any other Governmental
Entity or notified body with respect to any Product tested, manufactured,
distributed, or sold by Sellers or their affiliates, or failed to disclose a
material fact required to be disclosed to any Governmental Entity or notified
body.
(E)
SELLERS AND THEIR AFFILIATES AND THEIR OFFICERS, DIRECTORS AND
EMPLOYEES (AND TO THE KNOWLEDGE OF SELLERS, AGENTS) HAVE NOT, WITH RESPECT TO
THE BUSINESS:
(A) BEEN DEBARRED OR RECEIVED NOTICE OF ACTION OR THREAT OF
ACTION WITH RESPECT TO DEBARMENT UNDER THE PROVISIONS OF 21 U.S.C. §§ 335A,
335B, OR 335C, 42 U.S.C. § 1320A-7, 45 C.F.R. PART 76 OR ANY EQUIVALENT
PROVISIONS IN ANY OTHER JURISDICTION; OR (B) BEEN SUBJECT TO ANY OTHER
ENFORCEMENT ACTION INVOLVING THE FDA OR SIMILAR GOVERNMENTAL ENTITY IN ANY OTHER
JURISDICTION, INCLUDING ANY SUSPENSION, CONSENT DECREE, NOTICE OF CRIMINAL
INVESTIGATION, INDICTMENT, SENTENCING MEMORANDUM, PLEA AGREEMENT, COURT ORDER OR
TARGET OR NO-TARGET LETTER, AND NONE OF THE FOREGOING ARE PENDING, ASSERTED OR,
TO THE KNOWLEDGE OF SELLERS, THREATENED AGAINST SAME.
(F)
WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, EACH SELLER AND
ITS AFFILIATES ARE CONDUCTING THE BUSINESS AND USING THE TRANSFERRED ASSETS, AND
HAVE ALWAYS CONDUCTED THE BUSINESS AND USED THE TRANSFERRED ASSETS, IN
COMPLIANCE WITH THE ANTI-KICKBACK STATUTE (42 U.S.C. § 1320A-7B), CIVIL MONETARY
PENALTY STATUTE (42 U.S.C. § 1320A-7A), THE STARK LAW (42 U.S.C. § 1395NN), THE
FALSE CLAIMS ACT (31 U.S.C. § 3729 ET SEQ.) AND ALL OF THE REGULATIONS
PROMULGATED UNDER ALL SUCH STATUTES.
(G)
TO THE EXTENT APPLICABLE TO THE BUSINESS AND TO THE KNOWLEDGE OF
SELLERS:
(I)
EACH SELLER AND EACH AFFILIATE PAYS ONLY REASONABLE TRAVEL AND
MEAL COSTS FOR HEALTH CARE PROFESSIONALS RECEIVING TRAINING SPONSORED BY IT, AND
EACH SUCH HEALTH CARE PROFESSIONAL HAS A BONA FIDE NEED FOR SUCH TRAINING;
(II)
(A) EACH SELLER AND EACH AFFILIATE PROVIDES EDUCATIONAL GRANTS TO
THIRD PARTY EDUCATIONAL SPONSORS ONLY IF SUCH SPONSORS HAVE A GENUINE
EDUCATIONAL PURPOSE OR FUNCTION AND ONLY WHEN:
(X) THE EDUCATIONAL GATHERING IS
PRIMARILY DEDICATED TO PROMOTING OBJECTIVE SCIENTIFIC AND EDUCATIONAL ACTIVITIES
AND DISCOURSE; AND (Y) THE TRAINING INSTITUTION OR THE CONFERENCE SPONSOR
SELECTS THE ATTENDING HEALTH CARE PROFESSIONALS WHO ARE IN TRAINING AND (B) ANY
MEALS SPONSORED OR FURNISHED BY ANY SELLER OR AFFILIATE AT A CONFERENCE
SPONSORED BY A THIRD PARTY ARE OF MODEST VALUE;
(III)
EACH SELLER AND EACH AFFILIATE PAYS CONSULTANTS NO MORE THAN FAIR
MARKET VALUE FOR THEIR SERVICES, PLUS REASONABLE AND ACTUAL EXPENSES, AND ONLY
PURCHASES SERVICES FOR WHICH THERE IS A COMMERCIALLY REASONABLE NEED THAT IS
IDENTIFIED BY THE PARTIES IN ADVANCE;
(IV)
ANY GIFT FURNISHED BY A SELLER OR AN AFFILIATE HAS NEVER EXCEEDED
$100 AND HAS NEVER BEEN IN THE FORM OF CASH OR A CASH EQUIVALENT;
22
(V)
ALL GRANT MAKING FUNCTIONS FOR EACH SELLER AND AFFILIATE ARE
SEPARATED FROM EACH SUCH ENTITY'S SALES AND MARKETING FUNCTIONS; AND
(VI)
ALL PRICE CONCESSIONS OFFERED OR FURNISHED BY EACH SELLER AND
AFFILIATE TO PURCHASERS COMPLY WITH THE DISCOUNT SAFE HARBOR (42 C.F.R.
§