OTHER GOVERNMENTAL ENTITY,
INCLUDING, WITHOUT LIMITATION, CURRENT GOOD TISSUE PRACTICE REGULATIONS
PROMULGATED BY THE FDA, THE PHSA AND RELEVANT SECTIONS OF THE FDCA, AND
THE
UNITED STATES NATIONAL ORGAN TRANSPLANT ACT, TITLE 21 OF THE CODE OF FEDERAL
REGULATIONS PART 1271, HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE BASED
PRODUCTS AND (B) IS, AND AT ALL RELEVANT TIMES HAS CONFORMED IN ALL MATERIAL
RESPECTS TO ALL SPECIFICATIONS AND ANY PROMISES, WARRANTIES OR AFFIRMATIONS OF
FACT MADE IN ALL REGULATORY FILINGS OR SET FORTH IN ANY REGULATORY APPROVALS,
AUTHORIZATIONS OR CLEARANCES PERTAINING THERETO OR MADE ON THE CONTAINER OR
LABEL FOR SUCH PRODUCT OR IN CONNECTION WITH ITS SALE.
THERE IS NO DESIGN OR
MANUFACTURING DEFECT WITH RESPECT TO THE PRODUCTS.
(B)
SCHEDULE 2.19(B) SETS FORTH THE FORMS OF SELLER'S SERVICE OR
PRODUCT WARRANTIES THAT ARE CURRENTLY APPLICABLE TO SERVICES OR MERCHANDISE
RELATED TO THE BUSINESS (INCLUDING, WITHOUT LIMITATION, THE PRODUCTS).
EXCEPT
AS SET FORTH ON SCHEDULE 2.19(B), THERE ARE NO EXISTING OR, TO SELLER'S
KNOWLEDGE, THREATENED, CLAIMS AGAINST SELLER FOR SERVICES OR MERCHANDISE RELATED
TO THE BUSINESS WHICH ARE DEFECTIVE OR FAIL TO MEET ANY SERVICE OR PRODUCT
WARRANTIES OTHER THAN IN THE ORDINARY COURSE OF BUSINESS CONSISTENT WITH PAST
EXPERIENCE.
SELLER HAS NOT INCURRED LIABILITY ARISING OUT OF ANY INJURY TO
INDIVIDUALS AS A RESULT OF THE OWNERSHIP, POSSESSION, OR USE OF ANY PRODUCT AND,
TO SELLER'S KNOWLEDGE, THERE HAS BEEN NO INQUIRY OR INVESTIGATION MADE IN
RESPECT THEREOF BY ANY GOVERNMENTAL ENTITY.
Section 2.20
Environmental.
(A)
EXCEPT AS WOULD NOT BE REASONABLY LIKELY TO RESULT IN A MATERIAL
LIABILITY OF SELLER WITH RESPECT TO THE BUSINESS, (I) SELLER IS NOW AND ALWAYS
HAS BEEN IN COMPLIANCE WITH APPLICABLE LEGAL REQUIREMENTS WITH RESPECT TO
ENVIRONMENTAL LAWS, RULES, REGULATIONS AND ORDINANCES, AND (II) TO THE SELLER'S
KNOWLEDGE, NO UNDERGROUND STORAGE TANKS AND NO AMOUNT OF ANY SUBSTANCE THAT HAS
BEEN DESIGNATED BY ANY GOVERNMENTAL ENTITY OR BY ANY LEGAL REQUIREMENTS TO BE
RADIOACTIVE, TOXIC, HAZARDOUS OR OTHERWISE A DANGER TO HEALTH OR THE
ENVIRONMENT, INCLUDING PCBS, ASBESTOS, PETROLEUM, TOXIC MOLD, UREA-FORMALDEHYDE
AND ALL SUBSTANCES LISTED AS HAZARDOUS SUBSTANCES PURSUANT TO THE COMPREHENSIVE
ENVIRONMENTAL RESPONSE, COMPENSATION, AND LIABILITY ACT OF 1980, AS AMENDED, OR
DEFINED AS A HAZARDOUS WASTE PURSUANT TO THE UNITED STATES RESOURCE CONSERVATION
AND RECOVERY ACT OF 1976, AS AMENDED, AND THE REGULATIONS PROMULGATED PURSUANT
TO SAID LAWS, BUT EXCLUDING OFFICE AND JANITORIAL SUPPLIES (A "HAZARDOUS
MATERIAL"), ARE PRESENT IN, ON OR UNDER ANY PROPERTY OF SELLER USED IN THE
BUSINESS, INCLUDING THE LAND AND THE IMPROVEMENTS, GROUND WATER AND SURFACE
WATER THEREOF.
20
(B)
EXCEPT AS WOULD NOT BE REASONABLY LIKELY TO RESULT IN A MATERIAL
LIABILITY TO SELLER WITH RESPECT TO THE BUSINESS, SELLER HAS NOT TRANSPORTED,
STORED, USED, MANUFACTURED, DISPOSED OF, RELEASED, REMOVED OR EXPOSED ITS
EMPLOYEES OR OTHERS TO HAZARDOUS MATERIALS IN VIOLATION OF ANY LEGAL REQUIREMENT
OR MANUFACTURED ANY PRODUCT CONTAINING A HAZARDOUS MATERIAL IN VIOLATION OF ANY
LEGAL REQUIREMENT, NOR HAS SELLER RECEIVED NOTIFICATION FROM ANY PARTY THAT IT
HAS OR