AND PROVIDE *** WITH THE UPDATED OR CORRECTED INFORMATION.)
3.6
SUBCONTRACTORS.
*** MAY, SUBJECT TO
SUPERGEN'S PRIOR WRITTEN APPROVAL, USE SUBCONTRACTORS TO PERFORM ANY PART OF
THIS AGREEMENT, PROVIDED THAT SUCH SUBCONTRACTORS ARE BOUND BY A CONFIDENTIALITY
AGREEMENT WITH *** THAT PROTECTS THE CONFIDENTIAL INFORMATION OF SUPERGEN ON
TERMS AND CONDITIONS AT LEAST AS PROTECTIVE AS THOSE SET FORTH IN SECTIONS 11.3
- 11.6 AND MEET SUCH OTHER QUALITY STANDARDS AS MAY BE IMPOSED ON *** UNDER THIS
AGREEMENT.
3.7
HAZARDS.
*** WILL INFORM ITS EMPLOYEES,
CONTRACTORS AND OTHER PERSONNEL OF ANY KNOWN OR REASONABLY ASCERTAINABLE
CHEMICAL HAZARDS ASSOCIATED WITH THE MATERIALS, PRODUCT, OR ANY WASTES GENERATED
THROUGH PERFORMANCE OF THE MANUFACTURING AND PROCESSING ACTIVITIES HEREUNDER,
AND PROVIDE SUCH PERSONS WITH REQUIRED TRAINING IN THE PROPER METHODS OF
HANDLING AND DISPOSING OF SUCH ITEMS.
3.8
HANDLING OF MATERIALS; NOTIFICATION.
*** WILL
HANDLE, ACCUMULATE, LABEL, PACKAGE, STORE, TRANSPORT AND DISPOSE OF ALL WASTES
GENERATED THROUGH PERFORMANCE OF THE MANUFACTURING AND PROCESSING ACTIVITIES
HEREUNDER IN ACCORDANCE WITH ALL REGULATORY REQUIREMENTS.
*** WILL PROMPTLY
NOTIFY SUPERGEN IN WRITING OF ANY UNAUTHORIZED REPORTABLE RELEASE OR EMISSION OF
ANY WASTES GENERATED THROUGH PERFORMANCE OF THE MANUFACTURING AND PROCESSING
ACTIVITIES HEREUNDER AND ANY POTENTIAL ENVIRONMENTAL VIOLATION OR LITIGATION
RELATED THERETO.
TO THE EXTENT REQUIRED BY LAW, EACH PARTY WILL PROMPTLY NOTIFY
THE OTHER OF ANY HEALTH HAZARDS OR POTENTIAL HEALTH HAZARDS OF WHICH IT OR THEY
ARE OR BECOME AWARE OF CONCERNING EXPOSURE TO OR HANDLING OF THE MATERIALS OR
WASTES.
IN ANY OF THE FOREGOING INSTANCES, *** WILL PROMPTLY INFORM SUPERGEN OF
ANY REMEDIAL ACTIONS REQUIRED BY LAW AND WILL PROMPTLY UNDERTAKE SUCH ACTIONS.
4
3.9
CHANGES.
*** WILL NOT MAKE ANY CHANGES TO
MATERIALS (OR SUPPLIERS THEREOF), FORMULATIONS, PROCESSES, EQUIPMENT,
FACILITIES, SPECIFICATIONS, TESTS OR ANY OTHER ITEM IN ANY MANNER THAT WOULD
AFFECT THE MANUFACTURING OR PROCESSING ACTIVITIES TO BE PERFORMED BY *** UNDER
THIS AGREEMENT, OR AFFECTS ANY REGULATORY FILING, WITHOUT SUPERGEN'S PRIOR
WRITTEN APPROVAL.
SUPERGEN SHALL HAVE THE RIGHT TO MODIFY THE SPECIFICATIONS
FROM TIME TO TIME UPON REASONABLE ADVANCE WRITTEN NOTICE TO *** IF SUCH
MODIFICATIONS ARE REQUIRED OR RECOMMENDED BY A REGULATORY AUTHORITY OR NECESSARY
TO COMPLY WITH REGULATORY REQUIREMENTS OR OTHERWISE, BY MUTUAL AGREEMENT OF THE
PARTIES.
ALL SUCH MODIFICATIONS SHALL BE IN WRITING AND SHALL BE SIGNED BY AN
AUTHORIZED REPRESENTATIVE OF SUPERGEN AND ***, AND SHALL BE EFFECTIVE FOR ALL
ORDERS PLACED AFTER SUCH NOTICE.
IF SUCH MODIFICATIONS RESULT IN A CHANGE IN
***'S MANUFACTURING COSTS, THE PARTIES SHALL AGREE UPON AN APPROPRIATE
ADJUSTMENT TO THE PRICE OF THE PRODUCT HEREUNDER; AND IF SUCH MODIFICATIONS
RESULT IN A DELAY IN DELIVERY, THE PARTIES SHALL NEGOTIATE A REASONABLE
EXTENSION OF THE AFFECTED LEAD TIMES.
ARTICLE 4 - SUPPLY OF PRODUCT
4.1
EXCLUSIVITY DURING CLINICAL TRIALS.
DURING
THE COURSE OF CLINICAL TRIALS COVERING THE PRODUCT CONDUCTED PRIOR TO SUPERGEN'S
FIRST FILING OF A NDA FOR THE PRODUCT, SUPERGEN WILL PURCHASE FROM *** ***
(***%) OF ITS PRODUCT REQUIREMENTS NECESSARY TO SUPPORT SUCH CLINICAL
DEVELOPMENT ON THE TERMS AND