|
|
|
|
Document Preview Manufacturing and Supply Agreement [Amendment No. 4] |
||||
|
|
||||
|
Click "Add to Cart" button to purchase document. |
||||
|
|
||||
|
Title: |
Manufacturing and Supply Agreement [Amendment No. 4] |
|||
|
Entities: |
||||
|
Date: |
2005 |
|||
|
Size: |
Preview shows 6KB of 27KB total |
|||
|
Price: |
$42 |
|||
|
ID: |
#406104 |
|||
|
|
||||
|
||||
|
|
||||
|
Start of Preview |
||||
FOURTH AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
THIS FOURTH AMENDMENT (the "Amendment") is made and entered into as of January
10, 2005 (the "Amendment Effective Date") to the Manufacturing and Supply
Agreement entered into as of August 6, 1997, as amended, by and between JPI
PHARMACEUTICA INTERNATIONAL, a division of Cilag AG International Zug ("JPI"),
JANSSEN PHARMACEUTICA INC. ("JANSSEN US" and, together with JPI, "JANSSEN"), on
the one hand, and ALKERMES CONTROLLED THERAPEUTICS INC. II ("ACT II"), on the
other hand (the "Agreement").
RECITALS:
WHEREAS, JANSSEN and ACT II have entered into the Agreement; and
WHEREAS, JANSSEN and ACT II have also entered into an Addendum to the Agreement,
dated as of August 1, 2001 (the "Addendum"), regarding the expansion of ACT II's
manufacturing facilities; and
WHEREAS, the parties now wish to enter into this Amendment regarding the further
expansion of ACT II's manufacturing facilities, and the financial responsibility
of each of the parties in connection with such expansion;
NOW, THEREFORE, in consideration of the mutual promises contained herein and
other good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, the parties agree as follows:
1. DEFINITIONS. Unless provided otherwise, any capitalized terms used in this
Amendment that are not defined herein will have the meaning set forth in the
Agreement or the Addendum. The following terms will have the following meanings:
"Depreciation Credit" means an amount calculated by dividing the Total Third
Line Cost by the divisor of *, representing * for depreciation multiplied by *
of Product per year.
"FTE" means a full-time technical person dedicated by ACT II to perform
technical work on or directly related to the Third Line Plan, or in the case of
less than a full-time dedicated technical person, a full-time equivalent
technical person year, based upon a total of * (i.e., * of technical work on or
directly related to the Third Line Plan.
"FTE Hourly Rate" means the amount of *.
"Total Third Line Cost" means the total amount of the costs incurred by ACT II,
calculated as of the date of Validation Completion, for activities performed
pursuant to the Third Line Plan, including without limitation the purchase of
equipment and the design, engineering, construction and validation activities so
performed. In no event, shall the Total Third Line Cost exceed the overall
budget set forth in the Third Line Plan, unless such excess costs have been
approved by JANSSEN.
2. THIRD LINE. ACT II will design, engineer, construct and validate a third
wet process line at its manufacturing facility located in Wilmington, Ohio (the
"Third Line"). A description of the design, engineering, construction and
validation activities for the Third
{PAGE}
Line, including the equipment to be installed therein and the timeline and
budget for such design, engineering, construction and validation activities
(the "Third Line Plan") will be established by the parties. A draft Third Line
Plan including a project budget and project timeline is set forth in Exhibit A
to this Amendment.
3. APPROVAL OF THIRD LINE PLAN. Within * of the Amendment Effective Date, the
parties will meet to review and finalize the draft Third Line Plan. Any
modifications to the draft Third Line Plan affecting the anticipated timelines,
scope or budget thereof shall only become effective with the consent of both ACT
II and JANSSEN, which consent shall not be unreasonably withheld or delayed. The
final Third Line Plan will be attached to this Amendment as Exhibit A 1.
4. PERFORMANCE OF ACTIVITIES. Upon finalization of the Third Line Plan, ACT
II will begin to perform, and to have performed, the activities set forth
therein. ACT II will be responsible for the management of the design,
engineering, construction and validation of the Third Line. The Global Supply
Team, or a designated Sub-Team thereof, may, however, recommend actions to ACT
II following periodic reviews of the design, engineering, construction and
validation of the Third Line. Periodically ACT II may also notify the Global
Supply Team of proposed amendments to the Third Line Plan. Within * of receipt
of any proposed amendment to the Third Line Plan, the Global Supply Team, or the
designated Sub-Team, will meet to evaluate the amendment to the Third Line Plan
and to recommend actions; provided, however, that the scope, timelines or budget
set forth in the Third Line Plan may only be amended with the consent of both
ACT II and JANSSEN, which consent shall not be unreasonably withheld or delayed.
ACT II will keep the Global Supply Team, or any designated Sub-Team, regularly
informed, and at least on a quarterly basis, of issues and decisions affecting
the design, engineering, construction and validation of the Third Line and will
consult with the Global Supply Team, or any designated Sub-Team, before making
any decisions with respect thereto whenever possible.
5. PAYMENT. JANSSEN US will reimburse ACT II at the * for design,
|
End of Preview |
Home Intelligence Services Subscriptions News About Us