EXHIBIT 10.81
[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED
PENTOSTATIN SUPPLY AGREEMENT
THIS PENTOSTATIN SUPPLY AGREEMENT (the "Agreement") is effective as of the 13th
day of December, 2002 ("Effective Date") by and between Hauser Technical
Services, Inc., a Delaware corporation with principal offices at 6880 N.
Broadway, Ste. H, Denver, Colorado 80221 ("Hauser") and SuperGen, Inc., a
Delaware corporation with principal offices located at 4140 Dublin Blvd, Suite
200, Dublin, California 94568 ("SuperGen").
WHEREAS, SuperGen desires Hauser to batch process Pentostatin Crude Concentrate
in accordance with the Master Production Record (as defined herein) as allowed
by cGMP to yield pentostatin API (as used herein, pentostatin API is referred to
as "Active Pharmaceutical Ingredient" and "API");
WHEREAS, Hauser has the necessary facilities, personnel and professional
experience to batch process [***] of Pentostatin Crude Concentrate per Batch (as
defined herein) and perform Stability Studies (as defined herein); and
WHEREAS, SuperGen and Hauser desire to incorporate the terms and conditions of
the Quality Systems Agreement for Production of Pentostatin, executed by the
parties on August 30, 2002 (the "Quality Agreement"), as Exhibit A to this
Agreement.
NOW, THEREFORE, in consideration of the above and of the mutual covenants
contained herein and for other good and valuable consideration, the receipt of
which are hereby acknowledged, the parties agree as follows:
1.
DEFINITIONS
1.1
"AFFILIATE" OF A PARTY SHALL MEAN ANY CORPORATION OR OTHER BUSINESS
ENTITY CONTROLLED BY, CONTROLLING OR UNDER COMMON CONTROL WITH, SUCH PARTY.
FOR
THIS PURPOSE "CONTROL" SHALL MEAN DIRECT OR INDIRECT BENEFICIAL OWNERSHIP OF
MORE THAN FIFTY PERCENT (50%) OF THE VOTING OR INCOME INTEREST IN SUCH
CORPORATION OR OTHER BUSINESS ENTITY OR THE ABILITY TO DIRECT POLICY OR
MANAGEMENT OF SUCH CORPORATION OR OTHER BUSINESS ENTITY.
1.2
"ACTIVE PHARMACEUTICAL INGREDIENT" OR "API" IS DEFINED IN THE QUALITY
AGREEMENT.
1.3
"BATCH" IS DEFINED IN THE QUALITY AGREEMENT.
1.4
"BATCH RECORD" SHALL MEAN THE DOCUMENT(S) CREATED PURSUANT TO 21 CFR §
211.188 ET. SEQ., AS THE SAME MAY BE AMENDED, RELATING TO EACH BATCH THAT IS
PROCESSED THAT, IF COMPLETE AND ACCURATE, REFLECTS AND INCORPORATES ASPECTS OF
THE MASTER PRODUCTION RECORD SPECIFIC TO THE BATCH, AND SHALL INCLUDE, IF
APPLICABLE, PRODUCTION SUPPORT DOCUMENTS (LINE CLEARANCES AND CHARTS), TCA'S,
MRB'S, COPIES OF RAW ANALYTICAL DATA, A CERTIFICATE OF ANALYSIS, AND ANY
EXCEPTION REPORTS ISSUED WITH RESPECT TO SUCH BATCH.
1.5
"CONTRACT YEAR" SHALL MEAN THE 12-MONTH PERIOD COMMENCING ON THE
EFFECTIVE DATE OF THIS AGREEMENT, AND EACH SUBSEQUENT 12-MONTH PERIOD
THEREAFTER.
1.6
"CAMPAIGN" SHALL MEAN A MINIMUM OF THREE (3) BATCHES, BUT NO MORE THAN
FIVE (5) BATCHES.
1.7
"CERTIFICATES OF ANALYSIS" SHALL MEAN THE DOCUMENT(S) ASSOCIATED WITH
EACH OF THE RAW MATERIALS AND CONTAINERS USED WHEN EACH BATCH IS PROCESSED,
SPECIFYING THE RESULTS OF ANALYTICAL TESTING (IF APPLICABLE) ON SUCH RAW
MATERIALS AND CONTAINERS TO ASSURE SUCH RAW MATERIALS AND CONTAINERS MEET
APPROPRIATE RAW MATERIALS AND CONTAINERS SPECIFICATIONS.
1.8
"CGMPS" SHALL MEAN THE THEN CURRENT GOOD MANUFACTURING PRACTICES, AS
SPECIFIED IN REGULATIONS AT 21 CFR §§ 210-211 ET SEQ., AND BY