CASE OF A NON-CORPORATE ENTITY, THE POWER TO DIRECT OR CAUSE THE
DIRECTION OF THE MANAGEMENT AND POLICIES OF SUCH CORPORATION OR NON-CORPORATE
ENTITY, AS APPLICABLE;
(C)
"BATCH" OR "LOT" MEANS, WITH RESPECT TO THE PICOPLATIN API, EACH SEPARATE AND
DISTINCT QUANTITY OF PICOPLATIN API PROCESSED UNDER CONTINUOUS CONDITIONS AND
DESIGNATED BY A BATCH OR LOT NUMBER;
(D)
"BATCH RECORD" MEANS THE COMPLETE DETAILED MANUFACTURING AND CONTROL
INSTRUCTIONS AND SPECIFICATIONS FOR THE EACH BATCH OR LOT OF PICOPLATIN API,
WRITTEN AND SIGNED BY HERAEUS;
(E)
"BUSINESS DAYS" MEANS A DAY THAT IS NOT A SATURDAY OR A SUNDAY OR A NATIONAL
HOLIDAY IN THE UNITED STATES OR GERMANY;
(F)
"CERTIFICATE OF ANALYSIS" MEANS A DOCUMENT CERTIFYING A BATCH OR LOT OF
PICOPLATIN API MEETS THE SPECIFICATIONS, SIGNED AND DATED BY A DULY AUTHORIZED
REPRESENTATIVE OF THE QUALITY CONTROL OR QUALITY ASSURANCE DEPARTMENT OF
HERAEUS;
(G)
"CERTIFICATE OF COMPLIANCE" MEANS A DOCUMENT CERTIFYING THAT THE BATCH OR LOT OF
PICOPLATIN API WAS PROCESSED ACCORDING TO CGMP REQUIREMENTS AND THE
SPECIFICATIONS, SIGNED AND DATED BY A DULY AUTHORIZED REPRESENTATIVE OF HERAEUS;
(H)
"CGMP REQUIREMENTS" MEANS
(I)
THE CURRENT GOOD MANUFACTURING PRACTICES ESTABLISHED BY THE FDA, TPD AND EMEA
AND THE APPLICABLE FDA, TPD AND EMEA REGULATIONS, POLICIES OR GUIDELINES IN
EFFECT FOR THE MANUFACTURE, PROCESSING, PACKING AND HOLDING OF API PRODUCTS, AND
(II)
THE CORRESPONDING REQUIREMENTS OF EACH OTHER APPLICABLE JURISDICTION FOR WHICH
PONIARD INFORMS HERAEUS FROM TIME TO TIME IN WRITING THAT THE PICOPLATIN API IS
TO BE USED IN SUCH JURISDICTION AND TO WHICH HERAEUS AGREES IT CAN MEET SUCH
REQUIREMENTS;
(I)
"CONFIDENTIAL INFORMATION" MEANS ANY AND ALL KNOW-HOW, INFORMATION AND/OR
TECHNIQUES DISCLOSED BY PONIARD OR HERAEUS TO THE OTHER, AS THE CASE MAY BE,
RELATING TO THEIR RESPECTIVE TECHNOLOGIES, PRODUCTS, RESEARCH, PROCESSES AND
OTHER ACTIVITIES AND INFORMATION, INCLUDING, WITHOUT LIMITING THE GENERALITY OF
THE FOREGOING, ALL RESEARCH RESULTS, FORMULAE, MANUFACTURING METHODS AND
PROCESSES, DATA, SPECIFICATIONS, PLANS, DRAWINGS, PROTOTYPES, MODELS, DOCUMENTS,
2
RECORDINGS, INSTRUCTIONS, MANUALS, PAPERS, REPORTS, STUDIES, FINDINGS, BUSINESS
METHODS, OPERATING PROCEDURES, PRODUCTION CAPACITIES, PRICES, MARKET SHARE AND
OTHER MARKET DATA, CUSTOMER INFORMATION OR OTHER MATERIALS OF ANY NATURE
WHATSOEVER, WHETHER WRITTEN OR OTHERWISE, RELATING TO SAME, PROVIDED THAT SUCH
DISCLOSURES SHALL NOT BE CONSIDERED "CONFIDENTIAL INFORMATION" FOR THE PURPOSE
OF THIS AGREEMENT IF AND WHEN IT:
(I)
IS MADE SUBJECT TO AN ORDER BY JUDICIAL OR ADMINISTRATIVE PROCESS REQUIRING
PONIARD OR HERAEUS, AS THE CASE MAY BE, TO DISCLOSE ANY CONFIDENTIAL INFORMATION
OF THE OTHER, PROVIDED HOWEVER, THAT EITHER PARTY SHALL PROMPTLY NOTIFY THE
OTHER AND ALLOW THE OTHER REASONABLE TIME TO OPPOSE SUCH PROCESS BEFORE
DISCLOSING ANY OF THE CONFIDENTIAL INFORMATION OF THE OTHER;
(II)
IS OR BECOMES GENERALLY AVAILABLE TO THE GENERAL PUBLIC OTHER THAN THROUGH A
BREACH OF THIS AGREEMENT;
(III)
IS OBTAINED BY PONIARD OR HERAEUS FROM A THIRD PARTY WITH A VALID RIGHT TO
DISCLOSE IT, PROVIDED THAT SUCH THIRD PARTY IS NOT UNDER A CONFIDENTIALITY
OBLIGATION TO PONIARD OR HERAEUS, AS THE CASE MAY BE;
(IV)
IS INDEPENDENTLY DEVELOPED WITHOUT REFERENCE