"DILUENT" SHALL MEAN ANY INJECTABLE LIQUID PHARMACEUTICAL
FORMULATION REQUIRED TO RECONSTITUTE THE PRODUCT PRIOR TO INJECTION, FILLED IN A
PRIMARY CONTAINER.
1.20
"DOSAGE UNIT" SHALL MEAN A UNIT OF THE PRODUCT OR THE FINISHED
PRODUCT DETERMINED BY THE AMOUNT OF THE SINGLE DOSE OF NALTREXONE CONTAINED
THEREIN.
1.21
"DT" SHALL MEAN A DEVELOPMENT TEAM ESTABLISHED PURSUANT TO THE
LICENSE AND COLLABORATION AGREEMENT.
1.22
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR
ANY SUCCESSOR AGENCY.
*
CONFIDENTIAL TREATMENT REQUESTED
3
1.23
"FIELD" SHALL MEAN THE TREATMENT, PREVENTION OR DIAGNOSIS OF ANY
HUMAN DISEASE, DISORDER OR CONDITION, INCLUDING THE TREATMENT AND/OR PREVENTION
OF ALCOHOL ABUSE/DEPENDENCE.
1.24
"FINISHED PRODUCT" SHALL MEAN A FINISHED, PACKAGED, LABELED FINAL
DOSAGE UNIT OF THE PRODUCT PLUS DILUENT AND SYRINGES.
1.25
"FIRM PO" SHALL HAVE THE MEANING SET FORTH IN SECTION 3.8(A).
1.26
"FIRM ZONE" SHALL HAVE THE MEANING SET FORTH IN SECTION 3.7(D).
1.27
"[**] -YEAR FORECAST" SHALL MEAN A [**] YEAR ANNUAL FORECAST OF THE
PRODUCT REQUIREMENTS AND PLACEBO REQUIREMENTS IN EACH YEAR OF SUCH FORECAST,
STARTING WITH THE NEXT CALENDAR YEAR (I.E., THE CALENDAR YEAR FOLLOWING THE DUE
DATE OF SUCH FORECAST), PROVIDED THAT THE FORECAST FOR THE FIRST [**] MONTHS
SHALL BE BROKEN DOWN BY MONTH.
1.28
"FULLY BURDENED MANUFACTURING COST" SHALL MEAN THE COSTS INCURRED
(I.E., PAID OR ACCRUED) BY A PARTY, ITS AFFILIATES OR AGENTS IN THE MANUFACTURE
OF A PRODUCT, PLACEBO OR DILUENT, AS APPLICABLE, WHICH SHALL BE [**].
FULLY
BURDENED MANUFACTURING COST SHALL EXCLUDE [**] THAT ARE REQUIRED TO OBTAIN
REGULATORY APPROVAL FOR THE MEDISORB PRODUCT FOR THE INITIAL INDICATION (WHICH
COSTS SHALL BE BORNE SOLELY BY ALKERMES).
IN ADDITION, FOR THE AVOIDANCE OF
DOUBT, ANY MANUFACTURING DEVELOPMENT COSTS THAT ARE INCLUDED IN SHARED EXPENSES
AS DEVELOPMENT COSTS SHALL NOT BE INCLUDED AS PART OF THE FULLY BURDENED
MANUFACTURING COST.
1.29
"FTE" SHALL HAVE THE MEANING SET FORTH IN THE LICENSE AND
COLLABORATION AGREEMENT.
1.30
"GOVERNMENT AUTHORITY" SHALL MEAN ANY COURT, TRIBUNAL, AGENCY,
DEPARTMENT, LEGISLATIVE BODY, COMMISSION OR OTHER INSTRUMENTALITY OF ANY
FEDERAL, STATE, COUNTY, CITY OR OTHER POLITICAL SUBDIVISION IN THE TERRITORY.
1.31
"JSC" SHALL MEAN THE JOINT STEERING COMMITTEE ESTABLISHED PURSUANT
TO THE LICENSE AND COLLABORATION AGREEMENT.
1.32
"LAWS" OR "LAW" SHALL MEAN ALL APPLICABLE LAWS, STATUTES, RULES,
REGULATIONS, ORDINANCES AND OTHER PRONOUNCEMENTS HAVING THE BINDING EFFECT OF
LAW OF ANY APPLICABLE GOVERNMENT AUTHORITY, INCLUDING THE ACT.
*
CONFIDENTIAL TREATMENT REQUESTED
4
1.33
"LICENSE AND COLLABORATION AGREEMENT" SHALL MEAN THAT CERTAIN
LICENSE AND COLLABORATION AGREEMENT BY AND BETWEEN THE PARTIES ENTERED INTO AS
OF JUNE 23, 2005, AS SUCH AGREEMENT MAY BE AMENDED FROM TIME TO TIME.
1.34
"MANUFACTURING" (INCLUDING VARIATIONS SUCH AS "MANUFACTURE") SHALL
MEAN THE PERFORMANCE OF ANY AND ALL ACTIVITIES DIRECTED TO PRODUCING,
MANUFACTURING, PROCESSING, FILLING, FINISHING, PACKAGING, LABELING, QUALITY
CONTROL, QUALITY ASSURANCE, TESTING AND RELEASE, SHIPPING AND STORAGE OF THE
PRODUCT, FINISHED PRODUCT, PLACEBO, OR DILUENT AS APPLICABLE.
1.35
"NALTREXONE" SHALL MEAN [**].
1.36
"NDA" SHALL MEAN THE NEW DRUG APPLICATION NUMBER 21-897 FILED WITH
THE FDA