IN *** (THE "MANUFACTURING FACILITY").
*** WILL NOT
COMMENCE ANY MANUFACTURE OF PRODUCT FOR COMMERCIAL DISTRIBUTION UNTIL SUCCESSFUL
PROCESS VALIDATION IS COMPLETED PURSUANT TO TERMS OF THIS AGREEMENT.
*** MAY
CHANGE THE MANUFACTURING FACILITY, UPON PRIOR WRITTEN NOTICE AND APPROVAL BY
SUPERGEN, IF PRODUCT CAN BE MANUFACTURED AT THE NEW SITE IN ACCORDANCE WITH ALL
PERTINENT REGULATORY REQUIREMENTS, CGMPS, THE SPECIFICATIONS AND THE QUALITY
SYSTEMS AGREEMENT, AND DELIVERED IN ACCORDANCE WITH ***'S DELIVERY OBLIGATIONS
UNDER THIS AGREEMENT.
*** WILL BE RESPONSIBLE FOR ALL SCHEDULING RELATED TO THE
MANUFACTURING FACILITY AND FOR THE OPERATION OF SUCH FACILITY.
3.3
SUPPLY OF MATERIALS.
*** WILL BE SOLELY
RESPONSIBLE FOR PROCURING AND SUPPLYING ALL MATERIALS REQUIRED UNDER THE
DEVELOPMENT PROGRAM AND AS NECESSARY TO MEET ITS PRODUCT SUPPLY OBLIGATIONS
PURSUANT TO ARTICLE 4, AT ITS EXPENSE.
*** WARRANTS THAT ALL SUCH MATERIALS
MEET ALL APPLICABLE SPECIFICATIONS.
3.4
PROCESS DATA AND INFORMATION.
FOR PURPOSES OF
THIS AGREEMENT, ANY INFORMATION, DOCUMENTATION AND DATA RELATING TO PRODUCT
SAFETY, STABILITY, ALL ANALYTICAL SUPPORT METHODS, MANUFACTURING PROCESSES AND
METHODS, DRUG SUBSTANCE STABILITY DATA, IMPURITY PROFILES, REFERENCE STANDARDS
AND THE LIKE ASSOCIATED WITH THE PRODUCT OR ITS MANUFACTURE THAT SUPERGEN
PROVIDES OR HAS PREVIOUSLY PROVIDED TO ***, OR WHICH WAS RECEIVED FROM
PHARMACHEMIE B.V., IS CALLED THE "PRODUCT INFORMATION" AND SHALL BE DEEMED THE
CONFIDENTIAL INFORMATION (AS DEFINED BELOW) OF SUPERGEN.
IF *** REQUESTS
ADDITIONAL PRODUCT INFORMATION THAT SUPERGEN OWNS OR CONTROLS REASONABLY
NECESSARY FOR *** TO COMPLETE ITS OBLIGATIONS UNDER THIS AGREEMENT, SUPERGEN
WILL PROVIDE *** WITH SUCH INFORMATION IN A TIMELY FASHION.
FOR THE AVOIDANCE
OF DOUBT, ALL OF THE PRODUCT INFORMATION, WHETHER PROVIDED TO *** BEFORE OR
DURING THE TERM, IS AND SHALL REMAIN SUPERGEN'S PROPERTY, AND SUPERGEN RETAINS
ALL RIGHT AND TITLE TO SUCH PRODUCT INFORMATION.
3
3.5
SUPERGEN'S ASSISTANCE.
TO ASSIST *** IN ITS
PERFORMANCE OF THIS AGREEMENT, SUPERGEN WILL:
3.5.1
PROVIDE *** IN A TIMELY MANNER UPON REQUEST WITH ALL
REASONABLY RELEVANT INFORMATION, DOCUMENTATION AND DATA NECESSARY OR APPROPRIATE
FOR ***'S PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT, INCLUDING PRODUCT
INFORMATION, DOCUMENTATION AND DATA RELATING TO PRODUCT SAFETY, STABILITY,
ANALYTICAL SUPPORT METHODS, DRUG SUBSTANCE STABILITY DATA, IMPURITY PROFILES,
REFERENCE STANDARDS AND THE LIKE FOR THE PRODUCT, TO THE EXTENT SUCH ITEMS ARE
IN SUPERGEN'S POSSESSION OR CONTROL;
3.5.2
ENSURE THAT ALL MATERIALS SUPPLIED TO *** BY OR ON
BEHALF OF SUPERGEN PURSUANT TO THE DEVELOPMENT PROGRAM (AS MAY BE SET FORTH IN
EXHIBIT B) ARE SUITABLE FOR USE AS CONTEMPLATED UNDER THIS AGREEMENT, COMPLY
WITH ALL APPLICABLE LAWS AND REGULATIONS (INCLUDING THOSE RELATING TO THE IMPORT
OF SUCH MATERIALS) AND HAVE RECEIVED ALL REQUIRED GOVERNMENTAL AND REGULATORY
APPROVALS FOR USE HEREUNDER, INCLUDING CUSTOMS AND FDA APPROVALS; AND
3.5.3
PROVIDE *** WITH ALL INFORMATION IN SUPERGEN'S
POSSESSION OR CONTROL CONCERNING ANY HEALTH HAZARDS OR POTENTIAL HEALTH HAZARDS
ASSOCIATED WITH EXPOSURE TO OR THE HANDLING, STORAGE, USE OR DISPOSAL OF
PRODUCT, INCLUDING A MATERIAL SAFETY DATA SHEET FOR PRODUCT.
(IF ANY SUCH
INFORMATION IS UPDATED OR CORRECTED, SUPERGEN WILL PROMPTLY NOTIFY *** OF THAT
FACT