AGREED BY THE COMPANY (I) THAT NONE OF THE PURCHASERS HAVE BEEN ASKED TO AGREE,
NOR HAS ANY PURCHASER AGREED, TO DESIST FROM PURCHASING OR SELLING, LONG AND/OR
SHORT, SECURITIES OF THE COMPANY, OR "DERIVATIVE" SECURITIES BASED ON SECURITIES
ISSUED BY THE COMPANY OR TO HOLD THE SECURITIES FOR ANY SPECIFIED TERM; (II)
THAT PAST OR FUTURE OPEN MARKET OR OTHER TRANSACTIONS BY ANY PURCHASER,
INCLUDING SHORT SALES, AND SPECIFICALLY INCLUDING, WITHOUT LIMITATION, SHORT
SALES OR "DERIVATIVE" TRANSACTIONS, BEFORE OR AFTER THE CLOSING OF THIS OR
FUTURE PRIVATE PLACEMENT TRANSACTIONS, MAY NEGATIVELY IMPACT THE MARKET PRICE OF
THE COMPANY'S PUBLICLY-TRADED SECURITIES; (III) THAT ANY PURCHASER, AND COUNTER
PARTIES IN "DERIVATIVE" TRANSACTIONS TO WHICH ANY SUCH PURCHASER IS A PARTY,
DIRECTLY OR INDIRECTLY, PRESENTLY MAY HAVE A "SHORT" POSITION IN THE COMMON
STOCK, AND (IV) THAT EACH PURCHASER SHALL NOT BE DEEMED TO HAVE ANY AFFILIATION
WITH OR CONTROL OVER ANY ARM'S LENGTH COUNTER-PARTY IN ANY "DERIVATIVE"
TRANSACTION.
THE COMPANY FURTHER UNDERSTANDS AND ACKNOWLEDGES THAT (A) ONE OR
MORE PURCHASERS MAY ENGAGE IN HEDGING ACTIVITIES AT VARIOUS TIMES DURING THE
PERIOD THAT THE SECURITIES ARE OUTSTANDING, INCLUDING, WITHOUT LIMITATION,
DURING THE PERIODS THAT THE VALUE OF THE UNDERLYING SHARES DELIVERABLE WITH
RESPECT TO SECURITIES ARE BEING DETERMINED AND (B) SUCH HEDGING ACTIVITIES (IF
ANY) COULD REDUCE THE VALUE OF THE EXISTING STOCKHOLDERS' EQUITY INTERESTS IN
THE COMPANY AT AND AFTER THE TIME THAT THE HEDGING ACTIVITIES ARE BEING
CONDUCTED.
THE COMPANY ACKNOWLEDGES THAT SUCH AFOREMENTIONED HEDGING ACTIVITIES
DO NOT CONSTITUTE A BREACH OF ANY OF THE TRANSACTION DOCUMENTS.
19
(JJ)
MANIPULATION OF PRICE.
THE COMPANY HAS
NOT, AND TO ITS KNOWLEDGE NO ONE ACTING ON ITS BEHALF HAS, (I) TAKEN, DIRECTLY
OR INDIRECTLY, ANY ACTION DESIGNED TO CAUSE OR TO RESULT IN THE STABILIZATION OR
MANIPULATION OF THE PRICE OF ANY SECURITY OF THE COMPANY TO FACILITATE THE SALE
OR RESALE OF ANY OF THE SECURITIES, (II) SOLD, BID FOR, PURCHASED, OR, PAID ANY
COMPENSATION FOR SOLICITING PURCHASES OF, ANY OF THE SECURITIES (OTHER THAN FOR
THE PLACEMENT AGENT'S PLACEMENT OF THE SECURITIES), OR (III) PAID OR AGREED TO
PAY TO ANY PERSON ANY COMPENSATION FOR SOLICITING ANOTHER TO PURCHASE ANY OTHER
SECURITIES OF THE COMPANY.
(KK)
FDA.
AS TO EACH PRODUCT SUBJECT TO THE
JURISDICTION OF THE U.S. FOOD AND DRUG ADMINISTRATION ("FDA") UNDER THE FEDERAL
FOOD, DRUG AND COSMETIC ACT, AS AMENDED, AND THE REGULATIONS THEREUNDER ("FDCA")
THAT IS MANUFACTURED, PACKAGED, LABELED, TESTED, DISTRIBUTED, SOLD, AND/OR
MARKETED BY THE COMPANY OR ANY OF ITS SUBSIDIARIES (EACH SUCH PRODUCT, A
"PHARMACEUTICAL PRODUCT"), SUCH PHARMACEUTICAL PRODUCT IS BEING MANUFACTURED,
PACKAGED, LABELED, TESTED, DISTRIBUTED, SOLD AND/OR MARKETED BY THE COMPANY IN
COMPLIANCE WITH ALL APPLICABLE REQUIREMENTS UNDER FDCA AND SIMILAR LAWS, RULES
AND REGULATIONS RELATING TO REGISTRATION, INVESTIGATIONAL USE, PREMARKET
CLEARANCE, LICENSURE, OR APPLICATION APPROVAL, GOOD MANUFACTURING PRACTICES,
GOOD LABORATORY PRACTICES, GOOD CLINICAL PRACTICES, PRODUCT LISTING, QUOTAS,
LABELING, ADVERTISING, RECORD KEEPING AND FILING OF REPORTS, EXCEPT WHERE THE
FAILURE TO BE IN COMPLIANCE WOULD NOT HAVE A MATERIAL ADVERSE EFFECT.
THERE