OR COMES INTO THE PUBLIC DOMAIN WITHOUT A
BREACH BY THE RECEIVING PARTY OF THE RECEIVING PARTY'S DUTIES UNDER THIS
AGREEMENT,
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11.6.3
IS SUBSEQUENTLY INDEPENDENTLY CONCEIVED OR DISCOVERED BY THE
RECEIVING PARTY OR ITS EMPLOYEES WITHOUT ACCESS TO OR USE OF THE CONFIDENTIAL
INFORMATION OF THE DISCLOSING PARTY,
11.6.4
IS SUBSEQUENTLY DISCLOSED TO THE RECEIVING PARTY BY ANOTHER
PERSON WHO IS NOT UNDER AN OBLIGATION OF CONFIDENCE TO THE DISCLOSING PARTY, OR
11.6.5
A RECEIVING PARTY MUST DISCLOSE UNDER A NON-APPEALABLE
DECREE OR OTHER ORDER OF A COURT OR OTHER GOVERNMENTAL AUTHORITY.
A Receiving Party will promptly notify the Disclosing Party if and when a
Receiving Party becomes aware of any fact or circumstance that might reasonably
be expected to cause any information that a Disclosing Party has identified as
Confidential Information to fall within the scope of categories of
Sections 11.6.1 through 11.6.5 above.
ARTICLE 12 - ***'S REPRESENTATIONS, WARRANTIES AND COVENANTS
12.1
COMMERCIALLY REASONABLE EFFORTS.
*** REPRESENTS AND
WARRANTS TO SUPERGEN THAT *** WILL USE ITS COMMERCIALLY REASONABLE EFFORTS TO
SUCCESSFULLY COMPLETE THE DEVELOPMENT PROGRAM ACCORDING TO THE DEVELOPMENT
PROGRAM SCHEDULE.
SUPERGEN ACKNOWLEDGES, HOWEVER, THAT SINCE THE SERVICES ARE
OF A DEVELOPMENTAL OR RESEARCH NATURE, THERE CAN BE NO GUARANTEE, AND *** HAS
GIVEN NO GUARANTEE, THAT THE DEVELOPMENT PROGRAM WILL BE SUCCESSFULLY COMPLETED,
OR SUCCESSFULLY COMPLETED WITHIN THE CONTEMPLATED TIME FRAME, DESPITE ***'S
COMMERCIALLY REASONABLE EFFORTS TO DO SO.
12.2
PERFORMANCE STANDARDS.
*** REPRESENTS AND WARRANTS
TO SUPERGEN THAT *** WILL PERFORM ALL MANUFACTURING AND PROCESSING ACTIVITIES
HEREUNDER AND MAINTAIN THE MANUFACTURING FACILITY IN ACCORDANCE WITH CGMPS, THE
SPECIFICATIONS, THE QUALITY SYSTEMS AGREEMENT, ALL APPLICABLE REGULATORY
REQUIREMENTS AND OTHER REQUIREMENTS OF ANY GOVERNMENTAL AUTHORITY, AND SUCH
QUALITY ASSURANCE AND QUALITY CONTROL PRACTICES AS ARE STANDARD IN THE
PHARMACEUTICAL MANUFACTURING INDUSTRY.
12.3
QUALIFIED PERSONNEL.
*** REPRESENTS AND WARRANTS TO
SUPERGEN THAT *** WILL ENGAGE AND EMPLOY PROFESSIONALLY QUALIFIED PERSONNEL TO
PERFORM THE SERVICES CONTEMPLATED UNDER THIS AGREEMENT.
12.4
PRODUCT WARRANTY.
*** REPRESENTS AND WARRANTS TO
SUPERGEN THAT AT THE TIME OF DELIVERY, THE PRODUCT:
12.4.1
WILL CONFORM TO THE SPECIFICATIONS;
12.4.2
WILL HAVE BEEN MANUFACTURED IN COMPLIANCE WITH THE
REQUIREMENTS OF CGMP, INCLUDING BOTH 21 CFR PARTS 210 AND 211, AND ICH Q7A;
12.4.3
WILL HAVE BEEN MANUFACTURED IN COMPLIANCE WITH ALL
REGULATORY REQUIREMENTS;
12.4.4
WILL HAVE BEEN PACKAGED IN ACCORDANCE WITH SUPERGEN'S
SHIPPING GUIDELINES; AND
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12.4.5
WILL HAVE BEEN TRANSFERRED FREE AND CLEAR OF ANY LIENS OR
ENCUMBRANCES OF ANY KIND TO THE EXTENT ARISING THROUGH OR AS A RESULT OF THE
ACTS OR OMISSIONS OF ***, ITS AFFILIATES OR THEIR RESPECTIVE AGENTS.
12.5
DISCLAIMER.
THE WARRANTIES PROVIDED IN THIS
ARTICLE 12 ARE THE ONLY WARRANTIES *** HAS GIVEN SUPERGEN CONCERNING THE
PRODUCT.
SUCH WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS, GUARANTEES,
OR OTHER WARRANTIES INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR INTENDED USE AND/OR INFRINGEMENT, THAT *** MIGHT HAVE GIVEN OR WHICH MIGHT
BE PROVIDED OR IMPLIED BY LAW OR COMMERCIAL PRACTICE, WHICH OTHER WARRANTIES ARE
HEREBY EXCLUDED.
ARTICLE 13