OF HERAEUS'S
OPERATIONS FOR THE PRECEDING FISCAL YEAR;
(C)
HERAEUS IS UP-TO-DATE AND NOT IN DEFAULT IN
RESPECT OF ALL PAYMENTS TO BE MADE BY IT UNDER ANY LOANS, AGREEMENTS OR OTHER
FINANCING ARRANGEMENTS WITH ANY FINANCIAL INSTITUTION OR OTHER PERSON;
(D)
HERAEUS SHALL CONDUCT THE MANUFACTURING OF
THE PICOPLATIN API HEREUNDER IN A COMPETENT, WORKMANLIKE FASHION AND IN
ACCORDANCE WITH CGMP REQUIREMENTS, THE MASTER BATCH RECORD, THE SPECIFICATIONS
AND ANY APPLICABLE VALIDATION PROTOCOLS AT THE FACILITY AND ALL RELATED
MANUFACTURING FACILITIES AND EQUIPMENT SHALL SATISFY INSTALLATION QUALIFICATION
AND OPERATIONAL QUALIFICATION REQUIREMENTS, TAKING INTO ACCOUNT THE REQUIREMENTS
OF THE PROJECT;
14
(E)
THE MANUFACTURING OF THE PICOPLATIN API SHALL BE PERFORMED BY
HERAEUS IN ACCORDANCE WITH THE SCHEDULE SET OUT IN THE EXHIBITS A-E, IF THIS IS
TECHNICALLY FEASIBLE;
(F)
THE FACILITY, INCLUDING EQUIPMENT AND SYSTEMS, COMPLIES WITH CGMP
REQUIREMENTS;
(G)
EACH BATCH MANUFACTURED BY HERAEUS UNDER THIS AGREEMENT AND
DESIGNATED IN ADVANCE BY PONIARD AS A BATCH TO BE USED FOR FINAL DOSAGE
PHARMACEUTICAL PRODUCTS WHICH ARE INTENDED TO BE USED IN HUMANS SHALL COMPLY
WITH THE SPECIFICATIONS AND SHALL NOT BE ADULTERATED OR MISBRANDED WITHIN THE
MEANING OF THE ACT;
(H)
ALL ANALYTICAL WORK SHALL BE PERFORMED IN A MANNER AND IN A
LABORATORY WHICH COMPLIES WITH CGMP REQUIREMENTS AND ALL RELATED TESTING
PROCEDURES AS WELL AS ALL EQUIPMENT SHALL BE VALIDATED PRIOR TO THE PROCESSING;
(I)
HERAEUS SHALL NOT INTENTIONALLY INFRINGE OR MISAPPROPRIATE THE
INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY IN THE PROCESSING OF THE
PICOPLATIN API OR THE PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT.
THIS
SHALL NOT APPLY IF THE INFRINGEMENT OR MISAPPROPRIATION BY HERAEUS IS THE RESULT
OF COMPLYING WITH THE INSTRUCTIONS OF PONIARD;
(J)
ALL PERSONNEL FURNISHED BY HERAEUS TO PERFORM THE PROCESSING
SHALL BE QUALIFIED TO PERFORM THE TASKS AND FUNCTIONS WHICH THEY ARE ASSIGNED;
(K)
HERAEUS IS NOT DEBARRED AND HAS NOT AND SHALL NOT USE IN ANY
CAPACITY THE SERVICES OF ANY PERSON DEBARRED UNDER THE PROVISIONS OF THE GENERIC
DRUG ENFORCEMENT ACT OF 1992, AS AMENDED FROM TIME TO TIME AND HERAEUS SHALL
IMMEDIATELY NOTIFY PONIARD IF IT OR ANY OF ITS PERSONNEL BECOME SUBJECT OF A
DEBARMENT INVESTIGATION BY THE FDA;
(L)
THE PROCESSING OF THE PICOPLATIN API SHALL BE PERFORMED BY
HERAEUS IN ACCORDANCE WITH ALL IN GERMANY APPLICABLE NATIONAL, STATE AND LOCAL
LAWS, REGULATIONS, ORDERS AND GUIDELINES, INCLUDING, WITHOUT LIMITATION, ALL
ENVIRONMENTAL LAWS OF GERMANY;
(M)
HERAEUS HAS OBTAINED AND SHALL MAINTAIN IN FULL FORCE AND EFFECT
ALL APPLICABLE LICENSES, PERMITS, CERTIFICATES, AUTHORIZATIONS OR APPROVALS FROM
GOVERNMENTAL AUTHORITIES NECESSARY TO SUPPORT THE PROCESSING OF THE PICOPLATIN
API UNDER THIS AGREEMENT;
(N)
HERAEUS HAS NOT MADE AND SHALL NOT MAKE ANY COMMITMENTS TO THIRD
PARTIES INCONSISTENT WITH OR IN DEROGATION OF HERAEUS'S OBLIGATIONS UNDER THIS
AGREEMENT, AND HERAEUS IS FREE OF ANY OBLIGATIONS THAT WOULD PREVENT IT FROM
ENTERING INTO THIS AGREEMENT; AND
(O)
HERAEUS HAS NOT MADE AND SHALL NOT MAKE, IN THE PERFORMANCE OF THE
PROCESSING OF THE PICOPLATIN API HEREUNDER, ANY USE