THE CONSUMER
PRICE INDEX - URBAN WAGE EARNERS AND CLERICAL WORKERS, U.S. CITY AVERAGE, ALL
ITEMS, 1982-84 = 100, PUBLISHED BY THE UNITED STATES DEPARTMENT OF LABOR, BUREAU
OF LABOR STATISTICS (OR ITS SUCCESSOR EQUIVALENT INDEX).
1.23.
"CONTRACT YEAR".
CONTRACT YEAR MEANS THE PERIOD BEGINNING ON THE
EFFECTIVE DATE AND ENDING ON DECEMBER 31, 2007 (THE "FIRST CONTRACT YEAR"),
AND/OR EACH SUCCEEDING TWELVE (12) MONTH CALENDAR YEAR PERIOD THEREAFTER DURING
THE TERM (REFERRED TO AS THE "SECOND CONTRACT YEAR", "THIRD CONTRACT YEAR",
ETC.).
1.24.
"CONTROL" OR "CONTROLLED".
CONTROL OR CONTROLLED MEANS WITH
RESPECT TO ANY ITEM OF KNOW-HOW OR ANY INTELLECTUAL PROPERTY RIGHT, THE
POSSESSION, WHETHER BY OWNERSHIP OR LICENSE (OTHER THAN PURSUANT TO A LICENSE
GRANTED UNDER THIS AGREEMENT OR THE EXISTING US LOVENOX AGREEMENT), BY A PARTY
OR ANY OF ITS AFFILIATES OF THE ABILITY TO GRANT TO THE OTHER PARTY ACCESS
AND/OR A LICENSE AS PROVIDED HEREIN UNDER SUCH ITEM OR RIGHT WITHOUT VIOLATING
THE TERMS OF ANY AGREEMENT OR ARRANGEMENT WITH ANY THIRD PARTY EXISTING BEFORE
OR AFTER THE EFFECTIVE DATE.
1.25.
"CONTROLLED CONTRACTOR".
CONTROLLED CONTRACTOR MEANS (A) A THIRD
PARTY CONTRACTOR SUCH AS A CONTRACT RESEARCH ORGANIZATION, CONTRACT SERVICE
ORGANIZATION, CONTRACT
5
EMPLOYEE, CONSULTANT AND THE LIKE WHO MERELY CONDUCTS ACTIVITIES ON BEHALF OF
SUCH PARTY AND IS SUBJECT TO SUCH PARTY'S SUPERVISION AND CONTROL, OR (B) A
THIRD PARTY CONTRACT MANUFACTURER.
1.26.
"COPAXONE-EQUIVALENT PRODUCT".
COPAXONE-EQUIVALENT PRODUCT MEANS
(A) COPAXONE® IN INJECTABLE FORM SOLD AS A BRAND, INCLUDING COPAXONE® IF SOLD BY
TEVA AND/OR ITS CO-DISTRIBUTORS OR LICENSEES USING ANOTHER TRADENAME
(COLLECTIVELY, "BRANDED COPAXONE"), OR (B) ANY INJECTABLE PRODUCT SOLD IN THE
RELEVANT TERRITORY (OTHER THAN BRANDED COPAXONE) THAT IS A GENERIC A-RATED
THERAPEUTICALLY EQUIVALENT, FOR THE U.S. TERRITORY, OR FOREIGN EQUIVALENT
THEREOF, TO COPAXONE® IN INJECTABLE FORM.
FOR THE AVOIDANCE OF DOUBT,
COPAXONE-EQUIVALENT PRODUCT EXCLUDES ANY NEW CHEMICAL ENTITIES.
1.27.
"COPAXONE-REFERENCED PRODUCT".
COPAXONE-REFERENCED PRODUCT MEANS
INJECTABLE (SYRINGE AND VIAL) GLATIRAMER ACETATE FOR WHICH (A) THE REFERENCE
LISTED DRUG IS (I) LISTED IN US NEW DRUG APPLICATION NO. 020622 OR (II)
EQUIVALENTS OF SUCH REFERENCE LISTED DRUG IN EACH OTHER COUNTRY IN THE RELEVANT
TERRITORY, AND (B) AN APPLICATION COULD BE APPROVED BY THE RELEVANT REGULATORY
AUTHORITY.
FOR THE AVOIDANCE OF DOUBT, COPAXONE-REFERENCED PRODUCT EXCLUDES ANY
NEW CHEMICAL ENTITIES.
1.28.
"COST OF GOODS SOLD".
COST OF GOODS SOLD MEANS, WITH RESPECT TO A
PRODUCT, THE AGGREGATE OF EACH PARTY'S COST TO COMMERCIALLY MANUFACTURE, TEST,
PACKAGE AND/OR LABEL SUCH PRODUCT (INCLUDING THE BUILDUP OF COMMERCIAL
INVENTORY), CALCULATED AS FOLLOWS ("COST"):
1.28.1.
FOR SUCH PRODUCT, THE COST FOR MANUFACTURING, TESTING, PACKAGING,
AND/OR LABELING PERFORMED BY A THIRD PARTY SHALL EQUAL THE COSTS AS INVOICED BY
SUCH THIRD PARTY FOR THE MANUFACTURE, TESTING, PACKAGING AND/OR LABELING OF THE
SPECIFIED QUANTITY OF SUCH PRODUCT; AND
1.28.2.
FOR SUCH PRODUCT, THE COST FOR MANUFACTURING, TESTING, PACKAGING,
AND/OR LABELING PERFORMED BY SANDOZ OR ITS AFFILIATES SHALL EQUAL THE COSTS THAT
ARE INCURRED BY SANDOZ OR ITS AFFILIATES IN CONNECTION WITH THE MANUFACTURE,
TESTING, PACKAGING, LABELING AND DELIVERY TO A WAREHOUSE(S)