OF SUCH INSPECTION OR AUDIT BY HAUSER TO A THIRD PARTY, INCLUDING,
WITHOUT LIMITATION, SUPERGEN, HAUSER SHALL INFORM SUPERGEN OF SUCH RESULTS AND
HAUSER SHALL WORK TOGETHER IN PREPARING RESPONSES TO SUCH INSPECTION AND AUDIT;
PROVIDED, HOWEVER, SUPERGEN SHALL HAVE THE RESPONSIBILITY FOR SUBMITTING
RESPONSES ON FILING ISSUES RELATED TO THE PROCESS PROVIDED BY SUPERGEN TO
HAUSER, RELATED TO PENTOSTATIN CRUDE CONCENTRATE AND RELATED TO THE API, WHILE
HAUSER SHALL HAVE THE RESPONSIBILITY FOR SUBMITTING RESPONSES ON ISSUES RELATED
TO THE FACILITY; PROVIDED FURTHER, HOWEVER, TO THE EXTENT SUPERGEN DOES NOT
PROVIDE THE FOREGOING RESPONSES WITHIN THE DEADLINE SET BY THE REGULATORY
AUTHORITY, HAUSER SHALL HAVE THE RIGHT TO RESPOND ON SUCH MATTERS.
IF ANY
REGULATORY AUTHORITY DETERMINES THAT HAUSER IS NOT IN COMPLIANCE WITH ANY
APPLICABLE LAWS, RULES, REGULATIONS, OR REQUIREMENTS, TO THE EXTENT THE API OR
DELIVERABLES ARE OR COULD REASONABLY BE EXPECTED TO BE AFFECTED BY SUCH
NON-COMPLIANCE, HAUSER SHALL PROMPTLY INFORM SUPERGEN.
IN ADDITION, IF HAUSER
AGREES WITH SUCH DETERMINATION, HAUSER SHALL INFORM SUPERGEN OF ITS PLANS TO
COME INTO COMPLIANCE WITH SUCH LAWS, RULES, REGULATIONS AND REQUIREMENTS AND
SHALL CONTINUE TO KEEP SUPERGEN INFORMED OF ITS PROGRESS UNTIL COMPLIANCE HAS
BEEN ATTAINED.
SUPERGEN SHALL REIMBURSE HAUSER AT FULL BILLABLE RATES FOR
PENTOSTATIN-SPECIFIC INSPECTIONS.
HAUSER SHALL BEAR THE COST OF GENERAL CGMP
INSPECTIONS OR A GENERAL CGMP AUDIT, EVEN IF SUCH GENERAL INSPECTION OR AUDIT
FOCUSES ON PENTOSTATIN PROCESSES.
9.3
COMMUNICATIONS.
IF HAUSER INTENDS TO SUBMIT DOCUMENTATION TO THE
REGULATORY AUTHORITIES OR OTHERWISE COMMUNICATES WITH REGULATORY AUTHORITIES
(INCLUDING, WITHOUT LIMITATION, ONE OR MORE RESPONSES TO THE FDA UNDER SECTION
9.2), THEN TO THE EXTENT SUCH COMMUNICATIONS RELATE DIRECTLY TO THE API OR COULD
REASONABLY BE EXPECTED TO AFFECT THE API, HAUSER SHALL SUBMIT ALL SUCH
REGULATORY FILINGS AND OTHER COMMUNICATIONS JOINTLY WITH SUPERGEN OR SHALL
OBTAIN SUPERGEN'S ADVANCE NOTICE, CONSENT AND REASONABLE APPROVAL WITH RESPECT
TO THOSE ITEMS RELATED TO THE API.
HAUSER SHALL ADVISE SUPERGEN IN ADVANCE OF
ANY MATERIAL CHANGES HAUSER INTENDS TO MAKE TO ANY DOCUMENTS TO THE EXTENT THOSE
CHANGES RELATE DIRECTLY TO THE API, AND SHALL REQUEST THAT SUPERGEN SUBMIT SUCH
CHANGES TO THE FDA.
HAUSER SHALL NOTIFY SUPERGEN PROMPTLY OF ANY ADVERSE
FINDING BY ANY REGULATORY AUTHORITY THAT RELATES DIRECTLY TO THE API OR THAT
COULD REASONABLY BE EXPECTED TO AFFECT THE API.
9.4
MODIFICATIONS TO EQUIPMENT AND FACILITY.
HAUSER SHALL NOTIFY SUPERGEN
OF ANY MODIFICATIONS TO PARTS OF THE FACILITY USED FOR PROCESSING OR STORAGE IF
SUCH MODIFICATIONS IMPACT OR OTHERWISE COULD REASONABLY BE EXPECTED TO AFFECT
THE API OR THE MASTER PRODUCTION RECORD.
HAUSER SHALL NOT IMPLEMENT ANY
MATERIAL CHANGES (AS DEFINED BELOW) RELATING TO THE API WITHOUT OBTAINING PRIOR
WRITTEN APPROVAL FROM SUPERGEN, WHICH APPROVAL SHALL NOT BE UNREASONABLY
WITHHELD.
AS USED IN THIS SECTION 9.4, A "MATERIAL CHANGE" SHALL MEAN ANY
CHANGE THAT
(A) IMPACTS THE REGULATORY COMMITMENTS MADE TO REGULATORY
AUTHORITIES FOR THE API; OR (B) WILL REQUIRE REVALIDATION; OR (C) COULD
REASONABLY BE EXPECTED TO AFFECT THE QUALITY, PURITY, IDENTITY, STRENGTH OR
YIELD OF