BEEN RESERVED FOR IN
THE SELLERS' INVENTORY RESERVES, THE INVENTORY OF THE BUSINESS CONSISTS OF ITEMS
IN USABLE CONDITION AND SALEABLE IN THE ORDINARY COURSE OF THE BUSINESS.
2.16
PERMITS; REGULATORY MATTERS.
(A)
PERMITS.
(I)
SCHEDULE 1.1(A)(VII) SETS FORTH A TRUE AND COMPLETE LIST OF ALL
MATERIAL BUSINESS PERMITS.
(II)
EXCEPT AS SET FORTH IN SECTION 2.16(A)(II) OF THE DISCLOSURE
SCHEDULE AND EXCEPT FOR PERMITS (AS DEFINED BELOW) DICTATED BY THE LOCATION OF
THE FACILITIES, THERE ARE NO APPROVALS, LICENSES, PERMITS, CLEARANCES,
PERMISSIONS, EXEMPTIONS, CERTIFICATIONS, AUTHORIZATIONS, CONSENTS OF, OR
DECLARATIONS, REGISTRATIONS OR FILINGS WITH, ANY GOVERNMENTAL ENTITY ("PERMITS")
WHICH ARE REQUIRED FOR THE OPERATION OF THE BUSINESS AS CONDUCTED IN THE
ORDINARY COURSE AS OF SEPTEMBER 30, 2007, THE DATE OF THIS AGREEMENT AND THE
CLOSING DATE THAT ARE NOT INCLUDED IN THE BUSINESS PERMITS, OTHER THAN PERMITS
THE ABSENCE OF WHICH, INDIVIDUALLY OR IN THE AGGREGATE, TO MAINTAIN IN EFFECT OR
OBTAIN WOULD NOT REASONABLY BE EXPECTED TO RESULT IN A MATERIAL ADVERSE EFFECT
OR MATERIALLY ADVERSELY AFFECT BUYERS' ABILITY TO OWN AND OPERATE THE
TRANSFERRED ASSETS OR THE BUSINESS FOLLOWING THE CLOSING.
(III)
(X) EACH BUSINESS PERMIT IS VALID AND IN FULL FORCE AND EFFECT IN
ALL MATERIAL RESPECTS IN EVERY JURISDICTION IN WHICH IT IS REQUIRED PURSUANT TO
APPLICABLE LAWS; (Y) THE EXECUTION AND DELIVERY OF THIS AGREEMENT AND THE
ANCILLARY AGREEMENTS, AND THE CONSUMMATION OF THE TRANSACTIONS WILL NOT RESULT
IN ANY NON-RENEWAL, REVOCATION, CANCELLATION, SUSPENSION OR MODIFICATION OF ANY
BUSINESS PERMIT, EXCEPT AS WOULD NOT REASONABLY BE EXPECTED TO RESULT IN A
MATERIAL ADVERSE EFFECT; AND (Z) SELLERS ARE NOT IN VIOLATION IN ANY MATERIAL
RESPECT OF ANY BUSINESS PERMITS, AND NO CONDITION EXISTS THAT WITH NOTICE OR
LAPSE OF TIME OR OTHERWISE WOULD CONSTITUTE SUCH A VIOLATION UNDER THE BUSINESS
PERMITS.
(B)
FDA/EU APPLICATIONS.
SECTION 2.16(B) OF THE DISCLOSURE SCHEDULE
CONTAINS A LIST OF ALL FDA/EU APPLICATIONS THAT ARE OWNED BY SELLERS AND THEIR
AFFILIATES AND ARE PRIMARILY USED IN THE BUSINESS.
ALL OF SUCH FDA/EU
APPLICATIONS ARE IN GOOD STANDING, SUBSISTING, NOT ABANDONED, AND ARE, TO THE
KNOWLEDGE OF SELLERS, VALID AND ENFORCEABLE.
EXCEPT AS SET FORTH IN
SECTION 2.16(B) OF THE DISCLOSURE SCHEDULE, NO ACTIONS ARE DUE WITHIN NINETY
(90) DAYS AFTER THE DATE HEREOF TO MAINTAIN ANY SUCH FDA/EU APPLICATIONS.
"FDA
APPLICATIONS" MEANS ALL INVESTIGATIONAL DEVICE APPLICATIONS, 510(K) PREMARKET
NOTIFICATIONS, PREMARKET APPROVAL APPLICATIONS, SUPPLEMENTAL PREMARKET APPROVAL
APPLICATIONS, MASTER FILES, AS DEFINED IN 21 C.F.R. § 814.3, AND ALL SUPPLEMENTS
OR AMENDMENTS THERETO, WHETHER PENDING OR APPROVED OR CLEARED BY THE FDA.
"EU
APPLICATIONS" MEANS ALL CE MARKS, AND ANY APPLICATIONS OR ASSESSMENTS TO OBTAIN
MARKETING AUTHORIZATIONS IN THE EU, WHETHER PENDING OR APPROVED OR CLEARED BY
THE
27
APPLICABLE EU GOVERNMENTAL ENTITIES.
"FDA/EU APPLICATIONS" MEANS, COLLECTIVELY,
THE FDA APPLICATIONS AND THE EU APPLICATIONS.
(C)
EXCEPT AS IDENTIFIED IN SECTION 2.16(C) OF THE DISCLOSURE
SCHEDULE, NO GOVERNMENTAL ENTITY HAS ISSUED ANY WRITTEN NOTICE, WARNING LETTER,
REGULATORY LETTER, UNTITLED LETTER, FORM FDA 483, OR OTHER WRITTEN COMMUNICATION
OR CORRESPONDENCE, OR TO THE