IN SUITE NUMBER ONE AT
THE GUNBARREL FACILITY.
1.29
"PROCESSING FEES" SHALL MEAN THE PROCESSING FEES SET FORTH IN SCHEDULE
A OF THIS AGREEMENT.
1.30
"RAW MATERIALS" AND "COMPONENTS" SHALL HAVE THE MEANING SET FORTH IN
THE ATTACHED QUALITY AGREEMENT.
1.31
"REGULATORY AUTHORITY" IS DEFINED IN THE QUALITY AGREEMENT.
1.32
"SCHEDULES" SHALL MEAN THE SCHEDULES AND EXHIBITS ATTACHED HERETO AND
INCORPORATED HEREIN BY THIS REFERENCE.
1.33
"SPONSOR RELEASE LETTER" IS SHOWN, AS AN EXAMPLE, IN SCHEDULE E.
1.34
"SPECIFICATION" SHALL GENERALLY MEAN THOSE SPECIFICATIONS FOR RAW
MATERIALS, CONTAINERS AND API.
WHEN DETERMINING THE SPECIFICATIONS FOR RAW
MATERIALS AND CONTAINERS,
REFERENCE SHALL BE MADE TO THE PENTOSTATIN NDA
SUBMISSIONS AND SUPPLEMENT(S) THERETO OR CURRENT MASTER PRODUCTION RECORD AND
THE APPLICABLE VENDOR CERTIFICATES OF ANALYSIS.
WHEN DETERMINING THE
SPECIFICATIONS FOR API, REFERENCE SHALL BE MADE TO
P/N 4424 AND SCHEDULE B.
1.35
"STABILITY STUDIES" IS DEFINED IN THE QUALITY AGREEMENT.
1.36
"STABILITY STUDY FEES" SHALL MEAN THE STABILITY STUDY FEES SET FORTH IN
SCHEDULE A OF THIS AGREEMENT.
1.37
"SUPERGEN EQUIPMENT" HAS THE MEANING SET FORTH IN SECTION 13.
1.38
"USP" SHALL MEAN THE UNITED STATES PHARMACOPEIA.
3
1.39
"VALIDATION AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN SECTION
19.3.
1.40
"WASTE CONTRACTOR" SHALL MEAN A COMPANY RESPONSIBLE BY CONTRACT WITH
HAUSER FOR REMOVING HAZARDOUS AND NON-HAZARDOUS WASTES FROM HAUSER FACILITIES
AND DISPOSING OF WASTES ACCORDING TO STATE AND FEDERAL REGULATIONS.
1.41
"WORK -IN -PROCESS" SHALL MEAN ALL LABOR, THE PENTOSTATIN CRUDE
CONCENTRATE AND RAW MATERIALS EXPENDED OR INCLUDED IN PROCESSING THE API,
BEGINNING ON THE DATE SET-UP FOR MANUFACTURING IS INITIATED, AND ENDING ON THE
DATE PROCESSING IS CEASED.
2.
PROCESSING ARRANGEMENT
2.1
PROCESSING RESPONSIBILITY.
DURING THE TERM (AS DEFINED HEREIN),
HAUSER SHALL PROCESS THE PENTOSTATIN CRUDE CONCENTRATE WITH APPROVED AND
RELEASED RAW MATERIALS INTO API AND PRODUCE THE DELIVERABLES IN ACCORDANCE WITH
THE DIRECTIONS CONTAINED IN THE MASTER PRODUCTION RECORD AS ALLOWED BY CGMP.
HAUSER SHALL PROCESS THE BATCH WITH THE SKILLS REASONABLY REQUIRED OF A CONTRACT
RESEARCH ORGANIZATION THAT TESTS AND MANUFACTURES DRUG SUBSTANCES AND IS
REGULATED BY THE FDA.
HAUSER SHALL ALSO PROVIDE SUPERGEN THE BATCH RECORDS,
COPIES OF RAW DATA, ALL CALCULATED DATA, EXCEPTION REPORTS AND OTHER DOCUMENTS
APPROVED BY HAUSER'S QA DEPARTMENT FOR REVIEW PRIOR TO SHIPPING THE
DELIVERABLES.
HAUSER SHALL SHIP ALL DELIVERABLES WITH SUPERGEN'S INSTRUCTIONS.
2.2
SUB-CONTRACTING.
HAUSER SHALL NOT, WITHOUT PRIOR NOTIFICATION TO
SUPERGEN, SUB-CONTRACT ANY PART OF ITS RESPONSIBILITIES UNDER THIS AGREEMENT TO
ANOTHER PARTY.
3.
RAW MATERIALS, COMPONENTS, CONTAINERS, AND LABELING
3.1
SUPPLY.
UPON THE RECEIPT BY HAUSER OF (I) SUPERGEN'S FORECAST
PURSUANT TO SECTION 5.1, (II) A VALID PURCHASE ORDER FROM SUPERGEN, AND (III)
ADVANCE PAYMENT FROM SUPERGEN PURSUANT TO SECTION 6.5, HAUSER SHALL ACQUIRE THE
RAW MATERIALS AND CONTAINERS IN SUFFICIENT QUANTITY TO MEET THE REQUIREMENTS IN
THE PURCHASE ORDER.
IF HAUSER DETERMINES THAT THE CONTINUED SUPPLY OF ANY OF
THE RAW MATERIALS (EXCEPT PENTOSTATIN CRUDE CONCENTRATE) AND CONTAINERS MIGHT BE
INTERRUPTED OR NOT AVAILABLE IN A TIMELY FASHION OR IN ACCORDANCE WITH QUALITY
STANDARDS, THEN HAUSER SHALL