COST THE TRANSITION SERVICES SET FORTH ON SCHEDULE 4.1
FOR A PERIOD OF UP TO TWO MONTHS FROM THE EFFECTIVE DATE WHICH SERVICES EDWARDS
MAY TERMINATE IN WHOLE OR IN PART AT ANY TIME PRIOR TO THE EXPIRATION OF SUCH
TWO-MONTH PERIOD.
SECTION 4.2
APPROVALS. PLC SHALL AND PLC PARENT SHALL CAUSE PLC TO USE
COMMERCIALLY REASONABLE EFFORTS TO OBTAIN AND MAINTAIN ALL APPROVALS AND
CLEARANCES REQUIRED WITH RESPECT TO THE SALE OF THE PRODUCTS IN THE TERRITORY,
INCLUDING, WITHOUT LIMITATION, APPROVALS FROM THE FOOD AND DRUG ADMINISTRATION
(THE "FDA") AND THE ELECTRICAL TESTING LABORATORY ("ETL").
SECTION 4.3
LABELING OF PRODUCTS. PLC SHALL AND PLC PARENT SHALL CAUSE PLC TO
PROVIDE AND TO ASSUME REGULATORY RESPONSIBILITY FOR ALL FINISHED PRODUCT AND
PRODUCT-RELATED
4
LABELING, INCLUDING ALL SALES AND MARKETING LITERATURE, SUCH THAT IT COMPLIES
WITH ALL APPLICABLE LAWS AND REGULATIONS IN THE TERRITORY DURING THE TERM OF
THIS AGREEMENT. ALL LABELING FOR THE PRODUCTS SHALL INCLUDE THE STATEMENT
"DISTRIBUTED BY EDWARDS LIFESCIENCES LLC, MANUFACTURED BY PLC MEDICAL
SYSTEMS, INC."
SECTION 4.4
CLINICAL OR MARKETING STUDIES. PLC SHALL AND PLC PARENT SHALL CAUSE
PLC TO USE COMMERCIALLY REASONABLE EFFORTS TO CONDUCT ANY CLINICAL STUDY WITH
RESPECT TO THE PRODUCTS REQUIRED BY THE FDA OR OTHER GOVERNMENTAL AGENCIES TO
SELL OR MARKET THE PRODUCTS IN THE TERRITORY. ALL OTHER CLINICAL OR MARKETING
STUDIES WITH RESPECT TO THE PRODUCTS THAT ARE CONDUCTED WITHIN THE TERRITORY
WILL BE APPROVED, FUNDED, AND CONDUCTED ON TERMS AND CONDITIONS MUTUALLY AGREED
TO BY PLC AND EDWARDS.
SECTION 4.5
INSTALLATION SERVICES AND SERVICES PROVIDED UNDER EXTENDED SERVICE
AGREEMENTS. PLC SHALL AND PLC PARENT SHALL CAUSE PLC TO PROVIDE THE SERVICES AND
TECHNICAL SUPPORT RELATING TO THE PRODUCTS AS SET FORTH ON SCHEDULE 4.5 (THE
"SCHEDULE 4.5 SERVICES"). PLC SHALL RETAIN ALL SERVICE FEES AND REVENUES THAT IT
RECEIVES FROM END USERS FOR PROVIDING THE SCHEDULE 4.5 SERVICES, PROVIDED THAT
PLC SHALL PAY TO EDWARDS A COMMISSION OF [**]% OF ALL SUCH FEES AND REVENUES. IF
AND TO THE EXTENT THAT PLC FAILS TO PERFORM ITS OBLIGATION IN THE FIRST SENTENCE
OF THIS SECTION 4.5, EDWARDS MAY PROVIDE THOSE SCHEDULE 4.5 SERVICES OR CONTRACT
WITH A THIRD PARTY TO PROVIDE THOSE SCHEDULE 4.5 SERVICES. IN SUCH EVENT,
EDWARDS SHALL KEEP ALL SERVICE FEES AND REVENUES RESULTING THEREFROM AND PLC
SHALL TRAIN THE PERSONNEL (AT A RATE OF $[**] PER DAY) PERFORMING SUCH
SCHEDULE 4.5 SERVICES (WHETHER EMPLOYED BY EDWARDS OR A THIRD PARTY) AND PROVIDE
FACTORY SUPPORT, INCLUDING, WITHOUT LIMITATION, SPARE PARTS, TECHNICAL
TROUBLESHOOTING, AND PROCESSING PRODUCT RETURNS. PLC SHALL ALSO PROVIDE EDWARDS
WITH MONTHLY REPORTS WITH RESPECT TO PRODUCT RETURNS AND COMPLAINTS. EDWARDS
SHALL LOG IN ANY PRODUCTS RETURNED BY CUSTOMERS TO EDWARDS AND RETURN SUCH
PRODUCTS TO PLC. IF AN HL-2 LASER SYSTEM IS INSTALLED AND THE PRICE TO BE PAID
BY THE END USER FOR SUCH INSTALLATION IS LESS THAN $[**] PER DAY, PLC SHALL
INSTALL SUCH HL-2 LASER SYSTEM AND EDWARDS SHALL PAY PLC THE DIFFERENCE BETWEEN
$[**] AND THE AMOUNT TO BE PAID