OR DECLARATIONS, REGISTRATIONS OR
FILINGS WITH, ANY FEDERAL, STATE, LOCAL, MUNICIPAL, FOREIGN OR MULTI-NATIONAL
GOVERNMENTAL OR REGULATORY AUTHORITY, AGENCY, COMMISSION, COURT (INCLUDING ANY
ARBITRATION PANEL), BODY OR ENTITY, OR QUASI-GOVERNMENTAL, SELF-REGULATORY
ORGANIZATION, COMMISSION, BODY, AUTHORITY OR AGENCY (EACH A "GOVERNMENTAL
ENTITY") (INCLUDING ALL FDA APPLICATIONS (AS DEFINED BELOW)) THAT ARE PRIMARILY
USED IN THE BUSINESS, INCLUDING THOSE LISTED ON SCHEDULE 1.1(A)(VII) ("BUSINESS
PERMITS"), AND ALL DOCUMENTATION SPECIFICALLY RELATING TO ALL PRESENT AND PAST
PRODUCT CLINICAL TRIALS;
(VIII)
A LIST CONTAINING (A) THE NAMES AND ADDRESSES, TO THE EXTENT
AVAILABLE, OF EACH PERSON WHO PURCHASED, DURING THE PERIOD COMMENCING ON
JANUARY 1, 2006 AND ENDING ON THE DATE OF THIS AGREEMENT, ANY PRODUCTS AND
(B) THE AMOUNT OF PRODUCTS PURCHASED BY EACH SUCH PERSON DURING SUCH PERIOD;
(IX)
OTHER THAN DOCUMENTS RELATED TO THE PMA APPLICATION FOR AN SFA
INDICATION AND TO THE EXTENT TRANSFERABLE, ALL OF THE FOLLOWING TO THE EXTENT
THAT THEY PRIMARILY RELATE TO ANY EXISTING PRODUCT (IN EACH CASE, WHETHER SUCH
MATERIALS ARE EVIDENCED IN WRITING, ELECTRONICALLY OR OTHERWISE):
(A) ALL
MATERIAL BUSINESS RECORDS AND ALL PURCHASING RECORDS AND REGULATORY COMPLIANCE
RECORDS (INCLUDING EACH DEVICE MASTER RECORD ("DMR") FILE); (B) ALL REGULATORY
CORRESPONDENCE; (C) ALL MATERIAL RECORDS AND ALL WRITTEN CORRESPONDENCE
CONCERNING THE FDA APPLICATIONS (TOGETHER WITH ALL SUPPORTING AND BACKGROUND
DOCUMENTATION); (D) SUBMISSIONS AND REPORTS TO THE FDA OR ANY NOTIFIED BODY OR
COMPETENT AUTHORITY (INCLUDING ALL SUPPORTING AND BACKGROUND DOCUMENTATION);
(E) MANUALS AND PROCEDURES FOR ASSURING COMPLIANCE WITH FDA LAW AND EU LAW (AS
THOSE TERMS ARE DEFINED HEREUNDER), CE TECHNICAL FILES AND ALL OTHER RECORDS AND
MATERIALS NECESSARY TO COMPLY WITH FDA LAW AND EU LAW OR SIMILAR REQUIREMENTS OF
THIRD PARTY AUDITORS; (F) ALL DATA AND INFORMATION RELATING TO NONCLINICAL AND
CLINICAL TESTING OF PRODUCTS, INCLUDING ALL RECORDS RELATED TO THE CONTINUUM,
ETAGIUSS, MELOPEE, ELODIE PHASE I AND ELODIE PHASE II STUDIES; (G) RISK
MANAGEMENT RECORDS; (H) SUPPLIER AND VENDOR LISTS; (I)
SERVICE PROVIDER LISTS;
(J) PROMOTIONAL LITERATURE AND ADVERTISING MATERIALS WITH SUPPORT DATA;
(K) CATALOGS; (L) RESEARCH MATERIAL; (M) DESIGN HISTORY FILES, COMPLAINTS,
MEDICAL DEVICE REPORTS ("MDRS"); (N) CORRECTION AND REMOVAL REPORTS;
(O) CORRECTIVE AND PREVENTIVE ACTION REPORTS, WRITTEN MEMORANDA OR RECORDS
DOCUMENTING DECISIONS NOT TO FILE A 510(K); (P) OTHER PRODUCT DEVELOPMENT
RECORDS; AND (Q) ALL MATERIAL BUSINESS RECORDS, REGULATORY COMPLIANCE RECORDS
AND CORRESPONDENCE,
3
RESEARCH MATERIAL, DESIGN HISTORY FILES AND OTHER PRODUCT DEVELOPMENT RECORDS
RELATED TO PAST OR CURRENT R&D PROJECTS (COLLECTIVELY, "PRODUCT RECORDS");
(X)
(A) THE PURCHASE ORDERS AND COMMITMENTS OF CUSTOMERS OF THE
BUSINESS THAT ARE OUTSTANDING AND UNFULFILLED ON THE CLOSING DATE, (B) THE
MANUFACTURING AGREEMENT BY AND AMONG THE US SELLER AND ADMEDES SCHUESSLER GMBH,
DATED DECEMBER 6, 2006 (THE "MANUFACTURING AGREEMENT"), (C) ALL OTHER CONTRACTS
THAT ARE PRIMARILY USED IN THE BUSINESS, OTHER THAN THOSE CONTRACTS RELATING
PRIMARILY TO INTELLECTUAL PROPERTY AND OTHER THAN THE "SHARED CONTRACTS" SET
FORTH ON SCHEDULE 1.1(A)(X)(C) AND (D) CONTRACTS PRIMARILY USED IN THE BUSINESS
AND RELATING PRIMARILY TO INTELLECTUAL PROPERTY, INCLUDING THOSE CONTRACTS SET
FORTH IN SCHEDULE 1.1(A)(X)(D)