EXHIBIT 10.2
[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED
DRUG SUBSTANCE VALIDATION
AND SUPPLY AGREEMENT
This DRUG SUBSTANCE VALIDATION AND SUPPLY AGREEMENT (this "Agreement") is
effective as of July 2, 2003 (the "Effective Date") by and between *** ("***"),
a Delaware corporation located at ***, and SUPERGEN, INC. ("SuperGen"), a
Delaware corporation located at 4140 Dublin Road, Suite 200, Dublin, CA 94568
(each of *** and SuperGen, is referred to below as a "Party" and together as the
"Parties").
WHEREAS, *** has expertise and experience in conducting development related to
the synthesis of active pharmaceutical ingredients and has a research
development laboratory, pilot plant and commercial scale facilities to
manufacture such products, and *** is interested in providing such research,
development and manufacturing services to SuperGen;
WHEREAS, SuperGen has a commercial interest in the manufacture of the drug
substance Decitabine (hereinafter the "Product" as defined in more detail in
Exhibit A hereto) and wishes to use the services of *** in a phased development
program whereby *** will confirm, adapt and validate certain technology to
enable the commercial manufacture of the Product; and
WHEREAS, *** and SuperGen desire to enter into a relationship for such
development, manufacture, and supply of the Product according to the terms and
conditions of this Agreement.
NOW, THEREFORE, in consideration of the above and of the mutual covenants
contained herein and for other good and valuable consideration, receipt of which
are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1
DEFINITIONS.
EXHIBIT A SETS FORTH THE
DEFINITIONS OF CERTAIN TERMS USED IN THIS AGREEMENT.
THOSE TERMS SHALL HAVE THE
MEANINGS SET FORTH ON EXHIBIT A WHERE USED IN THIS AGREEMENT AND IDENTIFIED WITH
INITIAL CAPITAL LETTERS.
1.2
CONSTRUCTION.
FOR PURPOSES OF THIS AGREEMENT,
EXCEPT WHERE THE CONTEXT OTHERWISE REQUIRES:
(A)
ALL CURRENCY AMOUNTS STATED IN THIS AGREEMENT
ARE IN UNITED STATES DOLLARS.
(B)
REFERENCES TO "DAYS" MEAN CALENDAR DAYS.
(IF, HOWEVER, AN ACTION OR OBLIGATION IS DUE TO BE UNDERTAKEN BY OR ON A DAY
OTHER THAN A BUSINESS DAY, I.E., A SATURDAY, SUNDAY, OR PUBLIC HOLIDAY, IN THE
UNITED STATES, THEN THAT ACTION OR OBLIGATION WILL BE DEEMED TO BE DUE ON THE
NEXT FOLLOWING BUSINESS DAY.)
(C)
WHEN INTRODUCING A SERIES OF ITEMS, THE TERM
"INCLUDING" IS NOT INTENDED TO LIMIT THE MORE GENERAL DESCRIPTION THAT PRECEDES
THE ITEMS LISTED.
ARTICLE 2 - DEVELOPMENT PROGRAM
2.1
PROGRAM SCOPE.
*** WILL USE COMMERCIALLY
REASONABLE EFFORTS TO CARRY OUT THE DEVELOPMENT PROGRAM ATTACHED HERETO AS
EXHIBIT B ON THE TERMS AND CONDITIONS SET FORTH THEREIN AND IN THIS AGREEMENT.
THE DEVELOPMENT PROGRAM INCLUDES THE TERMS AND CONDITIONS BY WHICH *** SHALL:
2.1.1
DEVELOP AND CONFIRM THE EXISTING MANUFACTURING
PROCESS, INCLUDING EQUIPMENT AND CLEANING VERIFICATION, STABILITY TESTING,
PROCESS VALIDATION, AND MATERIAL AND PACKAGE TESTING;
2.1.2
ESTABLISH THE SPECIFICATIONS AND VALIDATED ANALYTICAL
TEST PROCEDURES FOR MATERIALS, MANUFACTURING, PACKAGING AND RELEASE OF THE
PRODUCT;
2.1.3
MANUFACTURE *** ENGINEERING DEMONSTRATION RUN AND ***
STABILITY/VALIDATION BATCHES OF PRODUCT AT AN APPROPRIATE REGULATORY SCALE;
2.1.4
PREPARE DOCUMENTATION