PROMPTLY INFORM SUPERGEN SO THAT THE PARTIES MAY
SEEK ALTERNATE SUPPLIERS.
THE COST OF THE RAW MATERIALS (EXCEPT PENTOSTATIN
CRUDE CONCENTRATE) AND CONTAINERS SHALL BE BORNE BY HAUSER.
IF THE PARTIES
MUTUALLY DETERMINE THAT IT MAKES BUSINESS SENSE FOR SUPERGEN TO SUPPLY ANY RAW
MATERIALS OR CONTAINERS FROM THE APPROVED VENDORS LISTED IN HAUSER'S
SPECIFICATION DOCUMENTS, THEN THE COST OF REQUIRED QUANTITIES OF RAW MATERIALS
OR CONTAINERS PURCHASED BY SUPERGEN AND SUPPLIED TO HAUSER SHALL BE DEDUCTED
FROM THE PRICE OF THE BATCHES INVOLVED, WHICH PRICE IS DETERMINED UNDER SECTION
6.4.
3.2
VERIFICATION.
PURSUANT TO 21 CFR § 211.84, DURING THE TERM HAUSER IS
RESPONSIBLE FOR INSPECTION AND TESTING COMPONENTS AND CONTAINERS ACCORDING TO
THE MUTUALLY AGREED-UPON QUALITY METHODS.
HAUSER SHALL CERTIFY THAT THE
COMPONENTS AND CONTAINERS RECEIVED MEET THE SPECIFICATIONS DOCUMENTED IN THE NDA
AND MOST CURRENT SUBMISSION.
3.3
AVAILABILITY.
THE PARTIES ACKNOWLEDGE THAT PERFORMANCE BY HAUSER
UNDER THIS AGREEMENT IS CONDITIONED UPON SUPERGEN'S PERFORMANCE IN PROVIDING
PENTOSTATIN CRUDE CONCENTRATE AND THE SUPERGEN EQUIPMENT, AND THAT SUCH
PERFORMANCE ALSO MAY BE AFFECTED BY THE SATISFACTORY AVAILABILITY OF QUALIFIABLE
RAW MATERIALS AND CONTAINERS.
TO THE EXTENT THAT HAUSER BECOMES AWARE OF
PROBLEMS WITH RESPECT TO THE AVAILABILITY OF QUALIFIABLE RAW MATERIALS AND
CONTAINERS, HAUSER WILL PROMPTLY NOTIFY SUPERGEN. HAUSER SHALL INFORM SUPERGEN
REASONABLY IN ADVANCE OF MAKING MAJOR CHANGES IN SUITE NUMBER ONE THAT WOULD
AFFECT ITS PERFORMANCE UNDER THIS AGREEMENT.
4
4.
CRUDE CONCENTRATE
4.1
DELIVERY OF PENTOSTATIN CRUDE CONCENTRATE.
AT LEAST TEN (10) CALENDAR
DAYS, BUT NOT MORE THAN THIRTY (30) CALENDAR DAYS, PRIOR TO THE START DATE FOR
PROCESSING EACH BATCH, SUPERGEN SHALL FURNISH TO HAUSER, AT NO COST TO HAUSER, A
SUFFICIENT AMOUNT OF PENTOSTATIN CRUDE CONCENTRATE TO PROCESS AT LEAST ONE (1)
BATCH, BUT NO MORE THAN NUMBER OF BATCHES IN ONE CAMPAIGN.
HAUSER WILL NOT BE
REQUIRED TO STORE PENTOSTATIN CRUDE CONCENTRATE FOR MORE THAN ONE CAMPAIGN.
4.2
PRODUCTION STANDARDS.
HAUSER SHALL USE ALL REASONABLE EFFORTS TO
PROCESS EACH BATCH (I) TO MEET THE YIELD SET FORTH IN THE MASTER PRODUCTION
RECORD; (II) IN ACCORDANCE WITH INSTRUCTIONS AND PRODUCTION REQUIREMENTS IN THE
MASTER PRODUCTION RECORD AS ALLOWED BY CGMP; AND (III) TO MEET THE SPECIFICATION
AND CGMP REQUIREMENT OF SUCH BATCH.
IT IS UNDERSTOOD BY THE PARTIES THAT
HAUSER'S RESPONSIBILITY IS TO PROCESS ACCORDING TO THE MASTER PRODUCTION RECORD
AS ALLOWED BY CGMP.
4.3
STORAGE.
OTHER THAN WHILE PROCESSING A BATCH, HAUSER SHALL STORE
PENTOSTATIN CRUDE CONCENTRATE AT A TEMPERATURE OF
-10 TO -30 DEGREES CENTIGRADE
AT ALL TIMES.
4.4
DAMAGE.
IF ANY DAMAGE OR LOSS OF PENTOSTATIN CRUDE CONCENTRATE OCCURS
PRIOR TO COMPLETING PROCESSING OF THE API AND SUCH DAMAGE OR LOSS IS THE RESULT
OF HAUSER'S MISHANDLING OF THE PENTOSTATIN CRUDE CONCENTRATE (WHETHER BY
NEGLIGENCE OR BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT (INCLUDING THE
QUALITY AGREEMENT AS INCORPORATED)), THEN TO REMEDY SUCH LOSS OR DAMAGE, HAUSER
SHALL CREDIT SUPERGEN ON THE NEXT INVOICE (OR IF IT IS THE LAST BATCH OF
CAMPAIGN, REIMBURSE SUPERGEN WITHIN 30 DAYS) FOR:
(A)
THE