TO THE OTHER'S CONFIDENTIAL
INFORMATION AS EVIDENCED BY PONIARD'S OR HERAEUS'S (AS THE CASE MAY BE) BUSINESS
RECORDS; OR
(V)
WAS POSSESSED BY EITHER PARTY PRIOR TO RECEIPT FROM THE OTHER, OTHER THAN
THROUGH PRIOR DISCLOSURE BY PONIARD OR HERAEUS, AS THE CASE MAY BE, AS EVIDENCED
BY THEIR BUSINESS RECORDS;
(J)
"CONFIDENTIALITY AGREEMENT" HAS THE MEANING ASCRIBED THERETO IN RECITAL C;
(K)
"DELIVERY DATE" MEANS THE DATE THAT PICOPLATIN API IS TO BE DELIVERED TO A
PONIARD DESIGNATED CARRIER AT HERAEUS'S FACILITIES;
(L)
"DEDICATED EQUIPMENT COST" MEANS THE COST OF EQUIPMENT DEDICATED TO THE
MANUFACTURE OF PICOPLATIN API AS DESCRIBED IN EXHIBIT C;
(M)
"EMEA" MEANS THE EUROPEAN MEDICINES EVALUATION AGENCY AND ANY SUCCESSOR THERETO;
(N)
"ENVIRONMENTAL LAWS" MEANS ALL APPLICABLE REQUIREMENTS UNDER APPLICABLE
STATUTES, REGULATIONS, RULES, ORDINANCES, CODES, LICENSES, PERMITS, ORDERS,
APPROVALS, PLANS OR OTHER AUTHORIZATIONS, AS AMENDED FROM TIME TO TIME, OF ALL
APPLICABLE NATIONAL, STATE AND LOCAL GOVERNMENTS AND REGULATORY AUTHORITIES
THEREOF AND ALL APPLICABLE JUDICIAL, ADMINISTRATIVE OR REGULATORY JUDGMENTS OR
ORDERS, RELATING TO THE PROTECTION OF HUMAN HEALTH OR THE ENVIRONMENT,
INCLUDING, WITHOUT LIMITATION, ANY AND ALL OCCUPATIONAL HEALTH AND SAFETY
REQUIREMENTS AND PROCEDURES FOR THE SAFE HANDLING OF THE PICOPLATIN API AND ANY
WASTE;
(O)
"FACILITY" MEANS HERAEUS'S MANUFACTURING FACILITY LOCATED AT HERAEUSSTR. 12 -
14, 63450 HANAU, GERMANY;
(P)
"FDA" MEANS THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND ANY SUCCESSOR
THERETO;
(Q)
"IMPROVEMENTS" MEANS, IN RELATION TO ANY INTELLECTUAL PROPERTY, ANY AND ALL
ADAPTATIONS, IMPROVEMENTS, ENHANCEMENTS, REVISIONS AND DERIVATIVE WORKS (WHETHER
COMPLETE OR INCOMPLETE) THEREOF;
(R)
"INSTALLATION QUALIFICATION" MEANS THE DOCUMENTED VERIFICATION REQUIRED TO
COMPLY WITH CGMP REQUIREMENTS THAT ALL KEY ASPECTS OF THE INSTALLATION OF THE
EQUIPMENT AND ANCILLARY SYSTEMS USED OR TO BE USED IN THE MANUFACTURING PROCESS
ADHERE TO THE APPROVED DESIGNS AND THE RECOMMENDATIONS OF THE MANUFACTURER;
3
(S)
"INTELLECTUAL PROPERTY" MEANS ANYTHING THAT IS PROTECTED BY ANY PATENTS,
TRADEMARKS, COPYRIGHTS, TRADE SECRETS OR ANY OTHER INTELLECTUAL OR INDUSTRIAL
PROPERTY RIGHTS WHATSOEVER AND WORLDWIDE (WHETHER REGISTERED OR UNREGISTERED AND
INCLUDING RIGHTS IN ANY APPLICATION FOR ANY OF THE FOREGOING);
(T)
"MANUFACTURING PROCESS" MEANS THE ACTIVITIES SET OUT IN EXHIBIT B, THE MASTER
BATCH RECORD AND HERAEUS'S STANDARD OPERATING PROCEDURES FOR THE PROCESSING AND
PACKAGING OF THE PICOPLATIN API;
(U)
"MANUFACTURING REPORT" MEANS A REPORT PREPARED BY HERAEUS SUMMARIZING THE
MANUFACTURING BATCHES AND STABILITY STUDY DATA RELATING TO PICOPLATIN API;
(V)
"MASTER BATCH RECORD" MEANS THE COMPLETE DETAILED MANUFACTURING AND CONTROL
INSTRUCTIONS AND SPECIFICATIONS FOR THE MANUFACTURING PROCESS FOR PICOPLATIN API
WRITTEN AND SIGNED BY HERAEUS, AS DEFINED BY THE CGMP REQUIREMENTS, AND AGREED
TO BY BOTH PARTIES, AND AS MAY BE REVISED BY BOTH PARTIES FROM TIME TO TIME;
(W)
"MATERIALS" MEANS RAW MATERIALS, SOLVENTS AND PACKAGING USED IN THE PROCESSING
TO PRODUCE THE PICOPLATIN API;
(X)
"NDA" MEANS A NEW DRUG APPLICATION, AS DEFINED IN THE ACT AND APPLICABLE
REGULATIONS PROMULGATED THEREUNDER, AS AMENDED FROM TIME TO TIME, AND ANY
FOREIGN EQUIVALENT;
(Y)
"OPERATIONAL QUALIFICATION" MEANS THE DOCUMENTED VERIFICATION REQUIRED TO COMPLY
WITH CGMP REQUIREMENTS THAT