TO EXERCISE
THE LICENSES GRANTED TO IT HEREUNDER.
1.89
"MAJOR EUROPEAN COUNTRY" MEANS EACH OF THE UNITED KINGDOM, GERMANY,
FRANCE, ITALY AND SPAIN.
1.90
"MANUFACTURE" OR "MANUFACTURING" OR "MANUFACTURED" MEANS ALL
OPERATIONS INVOLVED IN THE MANUFACTURE, RECEIPT, INCOMING INSPECTION, STORAGE
AND HANDLING OF RAW MATERIALS, AND THE MANUFACTURE, PROCESSING, PURIFICATION,
PACKAGING, LABELING, WAREHOUSING, QUALITY CONTROL TESTING (INCLUDING IN-PROCESS
RELEASE AND STABILITY TESTING), SHIPPING AND RELEASE OF COLLABORATION COMPOUNDS
AND/OR LICENSED PRODUCTS.
1.91
"MANUFACTURING COST" MEANS WITH RESPECT TO ANY LICENSED PRODUCT
MANUFACTURED BY OR ON BEHALF OF A PARTY, SUCH PARTY'S COSTS OF MANUFACTURING
SUCH LICENSED PRODUCT, WHICH SHALL BE THE SUM OF THE FOLLOWING COMPONENTS:
(A) DIRECT COSTS, INCLUDING MANUFACTURING LABOR AND MATERIALS DIRECTLY USED IN
MANUFACTURING SUCH LICENSED PRODUCT BY SUCH PARTY OR ITS AFFILIATES AND
ALLOCATED SUPERVISORY COSTS OF THE MANUFACTURING DEPARTMENT; (B) DIRECT LABOR
AND ALLOCATED SUPERVISORY COSTS OF NON-MANUFACTURING DEPARTMENTS (SUCH AS
QUALITY AND REGULATORY) ATTRIBUTABLE TO SUCH LICENSED PRODUCT; (C) AN ALLOCATION
OF DEPRECIATION OF FACILITIES, MACHINERY AND EQUIPMENT USED IN MANUFACTURE OF
LICENSED PRODUCT; (D) TOLL PROCESS AND OTHER CHARGES INCURRED BY SUCH PARTY OR
ITS AFFILIATES FOR OUTSOURCING THE MANUFACTURE OF THE LICENSED PRODUCT AND THE
COST OF SUPERVISING AND MANAGING THE THIRD PARTY MANUFACTURERS, AND OF RECEIPT,
INCOMING INSPECTIONS, STORAGE, PACKAGING, HANDLING QUALITY CONTROL TESTING AND
RELEASE OF THE OUTSOURCED ITEMS; (E) ALLOCATED GENERAL AND ADMINISTRATIVE COSTS,
INCLUDING, WITHOUT LIMITATION, PURCHASING, HUMAN RESOURCES, PAYROLL, LEGAL,
MAINTENANCE, INFORMATION SYSTEM AND ACCOUNTING, ATTRIBUTABLE TO SUCH LICENSED
PRODUCT; AND (F) ANY OTHER REASONABLE AND CUSTOMARY OUT-OF-POCKET COSTS BORNE BY
SUCH PARTY OR ITS AFFILIATES FOR THE TESTING, TRANSPORT, CUSTOMS CLEARANCE,
DUTY,
16
INSURANCE AND/OR STORAGE OF SUCH LICENSED PRODUCT.
FOR PURPOSES OF CLARITY, ALL
ALLOCATIONS UNDER THIS SECTION SHALL BE BASED ON SPACE OCCUPIED OR HEAD-COUNT OR
OTHER ACTIVITY-BASED METHOD.
1.92
"MANUFACTURING DEVELOPMENT" MEANS, WITH RESPECT TO A COLLABORATION
COMPOUND AND/OR LICENSED PRODUCT, ALL ACTIVITIES RELATED TO THE OPTIMIZATION OF
A COMMERCIAL-GRADE MANUFACTURING PROCESS FOR THE MANUFACTURE OF SUCH
COLLABORATION COMPOUND AND/OR LICENSED PRODUCT INCLUDING, WITHOUT LIMITATION,
TEST METHOD DEVELOPMENT AND STABILITY TESTING, FORMULATION, VALIDATION,
PRODUCTIVITY, TROUBLE SHOOTING AND NEXT GENERATION FORMULATION, PROCESS
DEVELOPMENT, MANUFACTURING SCALE-UP, STRAIN IMPROVEMENTS, DEVELOPMENT-STAGE
MANUFACTURING, AND QUALITY ASSURANCE/QUALITY CONTROL DEVELOPMENT.
1.93
"MECHANISM OF INHIBITION INFORMATION" MEANS ANY INFORMATION OR
TECHNOLOGY RELATING TO, OR ARISING OUT OF, THE MECHANISM BY WHICH ARQ 197, ANY
BACK-UP COMPOUND OR ANY PROPOSED BACK-UP COMPOUND INHIBITS *, INCLUDING WITHOUT
LIMITATION, ANY INFORMATION OR TECHNOLOGY RELATING TO THE BINDING OF ARQ 197,
ANY BACK-UP COMPOUND OR ANY PROPOSED BACK-UP COMPOUND TO ITS TARGET.
1.94
"MIT TUMOR" MEANS A MICROPHTHALMIA TRANSCRIPTION FACTOR TUMOR,
INCLUDING CLEAR CELL SARCOMA, ALVEOLAR SOFT PART SARCOMA AND RENAL CALL
CARCINOMA.
1.95
"NDA" MEANS A NEW DRUG APPLICATION, AS DEFINED IN THE FDCA AND
REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION OR PROCEDURE
REQUIRED TO SELL A PRODUCT IN THE UNITED STATES.
1.96
"NET SALES" MEANS THE GROSS AMOUNT BILLED OR INVOICED BY DS OR ANY
OF ITS AFFILIATES OR SUBLICENSEES TO THIRD PARTIES THROUGHOUT THE TERRITORY FOR
SALES OR OTHER