AND OFFICERS OF EACH SELLER AND ALL CURRENT EMPLOYEES,
INDEPENDENT CONTRACTORS AND CONSULTANTS OF EACH SELLER, ALONG WITH THE CURRENT
POSITION AND CURRENT SALARY AND BONUS FOR EACH SUCH PERSON.
NO SELLER IS
DELINQUENT IN PAYMENTS TO ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES, INDEPENDENT
CONTRACTORS OR CONSULTANTS FOR ANY WAGES, SALARIES, COMMISSIONS, BONUSES OR
OTHER COMPENSATION FOR ANY SERVICES PERFORMED BY THEM OR MATERIAL AMOUNTS
REQUIRED TO BE REIMBURSED TO SUCH DIRECTORS, OFFICERS, EMPLOYEES, INDEPENDENT
CONTRACTORS OR CONSULTANTS.
TO SELLERS' KNOWLEDGE, NO DIRECTOR, OFFICER OR
EMPLOYEE OF ANY SELLER IS IN VIOLATION OF ANY TERM OF ANY MATERIAL EMPLOYMENT
CONTRACT, INDEPENDENT CONTRACTOR AGREEMENT FOR SERVICES, PATENT DISCLOSURE
AGREEMENT, CONFIDENTIALITY AND INVENTION ASSIGNMENT AGREEMENT OR ANY OTHER
CONTRACT RELATING TO THE RELATIONSHIP OF SUCH DIRECTOR, OFFICER, EMPLOYEE WITH
ANY SELLER OR ANY OTHER PARTY BECAUSE OF
16
THE NATURE OF THE BUSINESS CONDUCTED OR CURRENTLY PROPOSED TO BE CONDUCTED BY
SELLERS.
EACH EMPLOYEE OF THE SELLERS, EACH CONSULTANT TO SELLERS WHO IN THE
ORDINARY PERFORMANCE OF SUCH CONSULTANT'S DUTIES ON BEHALF OF SUCH SELLER HAS
ACCESS TO CONFIDENTIAL INFORMATION RESPECTING SELLERS' BUSINESS INTELLECTUAL
PROPERTY, AND EACH OFFICER OF EACH SELLER HAS EXECUTED A CUSTOMARY
CONFIDENTIALITY AND ASSIGNMENT OF INVENTIONS AGREEMENT, AND COPIES OF ALL SUCH
AGREEMENTS HAVE BEEN PROVIDED TO PURCHASER.
(B)
NO SELLER IS BOUND BY ANY
COLLECTIVE BARGAINING, LABOR, OR
SIMILAR AGREEMENTS, INCLUDING MATERIAL LOCAL OR SIDE AGREEMENTS.
(C)
EACH SELLER IS IN COMPLIANCE WITH THE REQUIREMENTS OF THE
WORKERS ADJUSTMENT AND RETRAINING NOTIFICATION ACT OR ANY STATE-LAW EQUIVALENT
(COLLECTIVELY, "WARN") AND HAS NO LIABILITIES PURSUANT TO WARN.
4.23.
REGULATORY COMPLIANCE.
SELLERS HAVE DELIVERED TRUE AND CORRECT
COPIES OF THE REGISTRATIONS, PRE-MARKET NOTIFICATIONS, PRE-MARKET APPLICATIONS,
PRE-MARKET APPROVALS, AND INVESTIGATIONAL DEVICE EXEMPTION APPLICATIONS (AND ANY
AMENDMENTS OR SUPPLEMENTS THERETO) RELATED TO THE BUSINESS AND HAS DELIVERED
COPIES OF ALL MATERIAL WRITTEN COMMUNICATIONS BETWEEN ANY SELLER AND THE UNITED
STATES FOOD AND DRUG ADMINISTRATION ("FDA") OR ANY OTHER APPLICABLE GOVERNMENTAL
AUTHORITY REGULATING MEDICAL PRODUCTS AND ANY EXISTING WRITTEN SUMMARIES OF
MATERIAL DISCUSSIONS BETWEEN SUCH PARTIES THAT DESCRIBE MATTERS THAT ARE
MATERIAL TO ASSESSING COMPLIANCE OF THE BUSINESS.
THE OPERATION OF THE BUSINESS
IS IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH ALL FDA AND OTHER COMPARABLE
STATE AND LOCAL APPLICABLE LAWS APPLICABLE TO THE BUSINESS, INCLUDING FDA AND
COMPARABLE STATE AND LOCAL RULES AND REGULATIONS RELATING TO CLINICAL STUDIES OR
INVESTIGATIONS, GOOD PRACTICES, ADVERTISING AND PROMOTION, PRE- AND
POST-MARKETING ADVERSE DEVICE EXPERIENCE AND ADVERSE DEVICE EXPERIENCE
REPORTING, AND ALL OTHER PRE- AND POST-MARKETING REPORTING REQUIREMENTS, AS
APPLICABLE.
4.24.
HAZARDOUS SUBSTANCES.
EACH SELLER IS IN COMPLIANCE IN ALL MATERIAL
RESPECTS WITH ALL APPLICABLE LAWS GOVERNING OR RELATED TO ENVIRONMENTAL
MATTERS.
THERE ARE NO CLAIMS PENDING OR, TO THE KNOWLEDGE OF SELLERS,
THREATENED AGAINST ANY SELLER OR THE LEASED REAL PROPERTY RELATING TO ANY
APPLICABLE LAWS GOVERNING OR RELATED TO ENVIRONMENTAL MATTERS.
SELLERS HAVE NO
ACTUAL OR ALLEGED LIABILITY, WHETHER FIXED OR CONTINGENT, UNDER ANY
ENVIRONMENTAL LAW.
4.25.
BROKERS.
EXCEPT FOR WILLIAM BLAIR & COMPANY, NO BROKER, INVESTMENT
BANKER OR OTHER PERSON OR