MANUFACTURE OF THE PRODUCT.
ALKERMES SHALL MANUFACTURE THE PRODUCT
FOR SUPPLY TO CEPHALON.
ALKERMES SHALL MANUFACTURE, OR HAVE MANUFACTURED BY A
DESIGNATED THIRD PARTY, THE DILUENT, THE ADDITIONAL COMPONENTS, AND THE FINISHED
PRODUCT (PACKAGING AND LABELING OF THE PRODUCT) FOR SUPPLY TO CEPHALON.
3.3
MANUFACTURING DEVELOPMENT.
ALKERMES SHALL CONDUCT MANUFACTURING
DEVELOPMENT FOR THE PRODUCT TO REDUCE MANUFACTURING COST AND ENHANCE
MANUFACTURING OUTPUT.
THE ST SHALL SUBMIT A PLAN AND BUDGET FOR SUCH
MANUFACTURING DEVELOPMENT TO THE DT, WHICH IN TURN SHALL INCORPORATE THIS PLAN
INTO THE DEVELOPMENT PLAN SUBMITTED TO THE JSC FOR REVIEW AND APPROVAL.
SUCH
PLAN AND BUDGET SHALL BE CONSISTENT WITH, AND REASONABLY CALCULATED TO ENABLE
ALKERMES TO PERFORM, ITS OBLIGATIONS PURSUANT TO SECTION 3.15.
ALKERMES SHALL
THEN CONDUCT MANUFACTURING DEVELOPMENT IN ACCORDANCE WITH THE DEVELOPMENT PLAN
AND BUDGET APPROVED BY THE JSC.
3.4
MANUFACTURING FACILITY.
ALKERMES SHALL MANUFACTURE THE PRODUCT AT
THE ALKERMES MANUFACTURING FACILITY.
IN ACCORDANCE WITH THE TERMS AND
CONDITIONS SET FORTH IN THE QUALITY AGREEMENT, CEPHALON SHALL HAVE THE RIGHT
FROM TIME TO TIME, UPON REASONABLE ADVANCE NOTICE TO ALKERMES, TO INSPECT THE
ALKERMES MANUFACTURING FACILITY, TO REVIEW ALL RECORDS KEPT BY ALKERMES RELATING
TO THE MANUFACTURE OF PRODUCT HEREUNDER AND TO OBSERVE ALKERMES' CONDUCT OF
MANUFACTURING OPERATIONS WITH RESPECT TO THE
*
CONFIDENTIAL TREATMENT REQUESTED
9
PRODUCT.
3.5
STRATEGIC FORECAST.
THE ST WILL FORMULATE THE INITIAL STRATEGIC
FORECAST WITHIN [**] DAYS OF THE EFFECTIVE DATE.
PROMPTLY AFTER THE FORMULATION
OF THE LONG-RANGE COMMERCIALIZATION PLAN FOR THE PRODUCT PURSUANT TO THE LICENSE
AND COLLABORATION AGREEMENT, THE CT SHALL FORWARD THE LONG-RANGE
COMMERCIALIZATION PLAN TO THE ST.
THE ST WILL REVIEW THE STRATEGIC FORECAST IN
LIGHT OF SUCH LONG-RANGE COMMERCIALIZATION PLAN AND PROMPTLY NOTIFY THE CT IF
THE ST BELIEVES THAT THE COMMERCIALIZATION PLAN DOES NOT REFLECT GOOD FAITH
PROJECTIONS OF DEMAND FOR THE PRODUCT OR REQUIRES MANUFACTURING EFFORTS OR
RESOURCES BEYOND ALKERMES' OBLIGATIONS PURSUANT TO SECTION 3.15 OR THE
MANUFACTURING CAPACITY AS DESCRIBED IN THE STRATEGIC FORECAST.
IN SUCH CASE THE
ST TEAM LEADERS, THE DT TEAM LEADERS AND THE CT TEAM LEADERS WILL PROMPTLY
DISCUSS APPROPRIATE REVISIONS TO THE LONG-RANGE COMMERCIALIZATION PLAN AND/OR
THE STRATEGIC FORECAST, INCLUDING THE DEVELOPMENT OF ADDITIONAL CAPACITY FOR
MANUFACTURE OF THE PRODUCT IN ACCORDANCE WITH SECTION 5.3.
3.6
LABELING AND PACKAGING.
AT THE TIME OF CEPHALON'S SUBMISSION OF
ITS FORECAST PURSUANT TO SECTION 3.7, CEPHALON ALSO SHALL PROVIDE ALKERMES WITH
THE IMAGES AND TEXT DEVELOPED BY CEPHALON THAT ARE TO BE USED BY ALKERMES IN
PRODUCING LABELING, INSERTS AND PACKAGING FOR THE PRODUCT.
DIMENSIONS AND OTHER
PHYSICAL ATTRIBUTES OF SUCH LABELING, INSERTS AND PACKAGING SHALL BE SUBJECT TO
THE APPROVAL OF ALKERMES, WHICH APPROVAL SHALL NOT BE UNREASONABLY WITHHELD OR
DELAYED.
IN ADDITION AS HOLDER OF THE REGULATORY APPROVAL FOR THE PRODUCT,
ALKERMES SHALL HAVE THE RIGHT TO CONFIRM THAT LABELS, INSERTS AND PACKAGING FOR
THE PRODUCT ARE IN CONFORMITY WITH THE REGULATORY APPROVAL AND APPLICABLE LAWS.
3.7
FORECASTS.
(A)
INITIAL FORECASTS.
WITHIN [**] DAYS OF THE EFFECTIVE DATE, THE CT
SHALL PROVIDE TO THE