BY ALKERMES ON MARCH 31, 2005 WITH RESPECT TO THE PRODUCT.
1.37
"OUTBOUND COSTS" SHALL MEAN ANY OUTBOUND COSTS ASSOCIATED WITH THE
DELIVERY OF PRODUCT OR PLACEBO INCLUDING COSTS RELATED TO TRANSPORT, COLD
STORAGE SHIPPING CONTAINERS AND EXTERNAL STORAGE (IF REQUIRED) OF PRODUCT OR
PLACEBO, SUCH COSTS INCLUDING FREIGHT, DUTY, INSURANCE AND WAREHOUSING.
1.38
"PLACEBO" SHALL MEAN AN INACTIVE SUBSTITUTE FOR THE PRODUCT THAT
DOES NOT CONTAIN MEASURABLE QUANTITIES OF NALTREXONE.
1.39
"PLACEBO REQUIREMENTS" SHALL MEANS THE QUANTITIES OF PLACEBO
REQUIRED FOR THE CONDUCT OF PRE-CLINICAL STUDIES AND/OR CLINICAL STUDIES OF THE
PRODUCT IN THE FIELD PURSUANT TO A DEVELOPMENT PLAN.
1.40
"PROCEDURES" SHALL MEAN THE PROCEDURES FOR MANUFACTURING, CONTROL
AND TESTING THE PRODUCT AS SET FORTH IN THE NDA, AS SUCH PROCEDURES MAY BE
AMENDED BY AMENDMENT TO SUCH APPLICATIONS FROM TIME TO TIME.
1.41
"PRODUCT" SHALL MEAN THE INJECTABLE PHARMACEUTICAL PRODUCT
CONTAINING NALTREXONE UTILIZING ALKERMES' MEDISORB® SUSTAINED-RELEASE TECHNOLOGY
AS DESCRIBED IN THE NDA.
1.42
"PRODUCT REQUIREMENTS" SHALL MEAN CLINICAL REQUIREMENTS PLUS
COMMERCIAL REQUIREMENTS.
1.43
"QUALITY AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 3.12.
*
CONFIDENTIAL TREATMENT REQUESTED
5
1.44
"RECALL" SHALL MEAN ANY ACTION BY ALKERMES OR CEPHALON TO RECOVER
TITLE TO OR POSSESSION OF OR TO PREVENT THE DISTRIBUTION, PRESCRIPTION,
CONSUMPTION OR RELEASE OF A FINISHED PRODUCT OR PRODUCT SOLD OR SHIPPED TO THIRD
PARTIES.
THE TERM "RECALL" ALSO INCLUDES THE FAILURE BY ALKERMES OR CEPHALON TO
SELL OR SHIP A FINISHED PRODUCT OR PRODUCT TO THIRD PARTIES THAT WOULD HAVE BEEN
SUBJECT TO RECALL IF IT HAD BEEN SOLD OR SHIPPED.
1.45
"REGULATORY APPROVAL" SHALL MEAN ANY APPROVALS OF THE FDA NECESSARY
FOR THE MANUFACTURE, MARKETING OR SALE OF THE PRODUCT IN THE TERRITORY.
1.46
"ROLLING MONTHLY FORECAST" SHALL MEAN A ROLLING [**] MONTH FORECAST
SPECIFYING PRODUCT REQUIREMENTS AND PLACEBO REQUIREMENTS FOR EACH MONTH OF SUCH
FORECAST, STARTING WITH THE CALENDAR MONTH FOLLOWING THE DUE DATE OF SUCH
FORECAST.
1.47
"SEIZURE" SHALL MEAN ANY ACTION BY THE FDA TO DETAIN OR DESTROY A
FINISHED PRODUCT OR PRODUCT OR PREVENT THE DISTRIBUTION, PRESCRIPTION,
CONSUMPTION OR RELEASE OF A FINISHED PRODUCT OR PRODUCT.
1.48
"SHARED EXPENSES" SHALL HAVE THE MEANING SET FORTH IN THE LICENSE
AND COLLABORATION AGREEMENT.
1.49
"SPECIFICATIONS" SHALL MEAN THE SPECIFICATIONS FOR THE MANUFACTURE,
RELEASE, STORAGE, HANDLING AND PACKAGING OF THE PRODUCT AS SET FORTH IN THE NDA,
AS SUCH SPECIFICATIONS MAY BE AMENDED FROM TIME TO TIME AS PROVIDED HEREIN.
1.50
"STRATEGIC FORECAST" SHALL MEAN A REASONABLE ESTIMATE OF THE
LONG-RANGE (AT LEAST [**] YEARS) MANUFACTURING CAPACITY FORECAST FOR THE
ALKERMES MANUFACTURING FACILITY FOR SUPPLY TO CEPHALON PURSUANT TO THIS
AGREEMENT, THE CURRENT VERSION OF WHICH IS ATTACHED AS EXHIBIT A.
1.51
"SUPPLY TEAM" SHALL HAVE THE MEANING SET FORTH IN SECTION 2.1.
1.52
"TECHNOLOGY TRANSFER AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 6.3.
1.53
"TERM" SHALL HAVE THE MEANING SET FORTH IN SECTION 6.1.
1.54
"TERRITORY" SHALL MEAN THE UNITED STATES OF AMERICA, ITS TERRITORIES
AND POSSESSIONS, INCLUDING THE COMMONWEALTH OF PUERTO RICO.
1.55
"THIRD PARTY" SHALL