WILL NOT ASSERT
ANY OF ITS INTELLECTUAL PROPERTY RIGHTS AGAINST SUPERGEN WITH RESPECT TO THE
PROCESSES OR PROCEDURES USED TO MANUFACTURE PENTOSTATIN API PERFORMED BY OR ON
BEHALF OF SUPERGEN.
(E)
HAUSER WARRANTS THAT, TO ITS ACTUAL KNOWLEDGE, ITS
PROCESSES AND PROCEDURES FOR PROCESSING THE API DO NOT INFRINGE THE INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY.
14.2
SUPERGEN'S WARRANTIES.
SUPERGEN HEREBY REPRESENTS AND WARRANTS THAT
THE PENTOSTATIN CRUDE CONCENTRATE SHALL, AT THE TIME IT IS SHIPPED TO HAUSER.
(A)
NOT BE ADULTERATED OR MISBRANDED WITHIN THE MEANING OF
THE FEDERAL FOOD DRUG AND COSMETIC ACT ("FFDCA") OR WITHIN THE MEANING OF ANY
APPLICABLE STATE OR MUNICIPAL LAW IN WHICH THE DEFINITIONS OF ADULTERATION AND
MISBRANDING ARE SUBSTANTIALLY THE SAME AS THOSE CONTAINED IN THE FFDCA;
(B)
NOT BE ARTICLES THAT MAY NOT, UNDER SECTION 505 OF THE
FFDCA OR ANY OTHER PROVISION OF THE FFDCA OR ANY OTHER APPLICABLE LAW, STATUTE
OR REGULATION, BE INTRODUCED INTO INTERSTATE COMMERCE;
(C)
HAVE BEEN MANUFACTURED, PROCESSED, AND PACKED IN
COMPLIANCE WITH ALL REQUIREMENTS UNDER THE FFDCA (INCLUDING DRUG ESTABLISHMENT
REGISTRATION AND APPLICABLE GOOD MANUFACTURING PRACTICE) OR UNDER ANY OTHER
APPLICABLE LAWS, RULES, OR REGULATIONS OF THE UNITED STATES OR ANY OTHER COUNTRY
IN WHICH THE PENTOSTATIN CRUDE CONCENTRATE IS MANUFACTURED; AND
(D)
CONFORM TO THE IDENTIFICATIONS FOR THE PENTOSTATIN CRUDE
CONCENTRATE SET FORTH IN THE MASTER PRODUCTION RECORD AND CONFORM TO THE RELEASE
SPECIFICATIONS DOCUMENTED IN THE CERTIFICATE OF ANALYSIS INCLUDED WITH EACH
DELIVERY OF PENTOSTATIN CRUDE CONCENTRATE, CONFIRMING THE IDENTITY AND PURITY OF
SUCH PENTOSTATIN CRUDE CONCENTRATE.
(E)
TO THE ACTUAL KNOWLEDGE OF SUPERGEN, THE HANDLING, USE,
PACKAGING, SALE OR DISTRIBUTION BY SUPERGEN OR ITS AFFILIATES OF THE PENTOSTATIN
CRUDE CONCENTRATE OR API DOES NOT INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF
ANY THIRD PARTIES.
14.3
DISCLAIMER.
NEITHER PARTY MAKES ANY WARRANTIES, EITHER EXPRESS,
IMPLIED OR OTHERWISE, EXCEPT THOSE HEREIN EXPRESSLY PROVIDED.
HAUSER
SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS
FOR A PARTICULAR PURPOSE OF ANY FINISHED PRODUCT WHICH INCORPORATES OR UTILIZES
THE WORK PRODUCT HEREUNDER.
SUPERGEN SPECIFICALLY DISCLAIMS THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND OF
14
FITNESS FOR A PARTICULAR PURPOSE OF THE PENTOSTATIN CRUDE CONCENTRATE SUPPLIED
TO HAUSER FOR WORK PERFORMED HEREUNDER.
15.
RECALLS AND PRODUCT LIABILITY ISSUES
IF ANY REGULATORY AUTHORITY OR LAW SHALL REQUEST OR REQUIRE THE RECALL OF ALL OR
SOME OF THE API (INCLUDING, WITHOUT LIMITATION, THE FINISHED FORMULATED PRODUCT
INCORPORATING THE API) OR REQUIRE THE DISSEMINATION OF INFORMATION REGARDING THE
API, SUPERGEN SHALL PROMPTLY NOTIFY HAUSER IN WRITING PURSUANT TO SECTION 22 OF
SUCH RECALL OR REQUIRED DISSEMINATION AND SUPERGEN SHALL CONSULT WITH HAUSER
REGARDING THE TIMELY COMPLIANCE WITH ALL APPLICABLE LAWS AND REGULATIONS. IF
THERE IS AN INQUIRY BY ANOTHER PUBLIC AGENCY HAVING JURISDICTION OR BY A PRIVATE
PARTY WITH LEGAL STANDING, THEN THE PARTY WITH KNOWLEDGE OF SUCH INQUIRY SHALL
INFORM THE OTHER PARTY PROMPTLY AFTER IT BECOMES AWARE OF SUCH INQUIRY.
IN ANY
OF THE FOREGOING CIRCUMSTANCES, HAUSER SHALL COOPERATE AS REASONABLY REQUIRED
AND AT THE REQUEST OF