EXHIBIT 10.4
WHEREVER CONFIDENTIAL INFORMATION IS OMITTED HEREIN (SUCH OMISSIONS ARE DENOTED
BY AN ASTERISK), SUCH CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED SEPARATELY TO
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT.
FOURTH AMENDMENT TO DEVELOPMENT AGREEMENT
FIRST AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
This Agreement shall be the Fourth Amendment to the Development Agreement by and
between Xxxxxxx Pharmaceutica International, a division of Cilag International
AG, having its place of business in XX-0000 Xxx, Xxxxxxxxxxx ("XXXXXXX") and
Medisorb Technologies International, A Delaware limited partnership
("Medisorb"), which agreement has in the meantime been duly assigned from
Medisorb to Alkermes Controlled Therapeutics Inc. II, a company organized and
existing under the laws of the Commonwealth of Pennsylvania, 00 Xxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000-0000, X.X.X. ("ACT II") by a deed of assignment dated. March
1, 1996.
This Agreement shall also be the First Amendment to the Manufacturing and Supply
Agreement by and between JPI PHARMACEUTICA INTERNATIONAL, a division of Cilag AG
International Zug, a company duly organized and existing under the laws of
Switzerland, having its principal office in CH-6300 Zug, Xxxxxxxxxxxxx 00,
Xxxxxxxxxxx (hereinafter referred to as "JPI"), and XXXXXXX PHARMACEUTICA Inc.,
0000 Xxxxxxx-Xxxxxxxxxx Xxxx, Xxxxxxxxxx, XX 00000, XXX (hereinafter referred to
as "XXXXXXX US") and ACT II, which agreement has since been duly transferred
from XXXXXXX PHARMACEUTICA INC. TO XXXXXXX PHARMACEUTICA PRODUCTS, L.P. (JPI and
XXXXXXX US collectively referred to herein as "XXXXXXX").
WHEREAS XXXXXXX and ACT II desire to amend certain terms of the Development
Agreement and the Manufacturing and Supply Agreement with respect to the
ownership of certain capital equipment.
NOW THEREFORE, the parties agree to amend the Development Agreement and the
Manufacturing and Supply Agreement as follows:
1. Notwithstanding the provisions of Section 4 of the SECOND AMENDMENT to the
Development Agreement and Section 2.2 of the Manufacturing and Supply
Agreement, XXXXXXX agrees to sell to ACT II and ACT II agrees to purchase
from XXXXXXX the equipment described on Exhibit A, attached hereto and
made a part hereof (the "Equipment") for good and valuable consideration
of $1.00 (one U.S. dollar).
2. THE EQUIPMENT IS SOLD "WHERE IS; AS IS" WITHOUT ANY REPRESENTATION OR
WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY REPRESENTATION OR WARRANTY AS TO THE DESIGN, QUALITY OR
CONDITION OF THE EQUIPMENT, ANY WARRANTY OF MERCHANTABILITY OR FITNESS OF
THE
EQUIPMENT FOR ANY PARTICULAR PURPOSE OR AS TO THE OTHER MATTER RELATING TO
THE EQUIPMENT OR ANY PART THEREOF. ACT II CONFIRMS THAT IT HAS SELECTED
THE EQUIPMENT ON THE BASIS OF ITS OWN JUDGMENT AND EXPRESSLY DISCLAIMS
RELIANCE UPON ANY STATEMENTS, REPRESENTATIONS OR WARRANTIES MADE BY
XXXXXXX.
3. ACT II HEREBY ASSUMES AND RELEASES XXXXXXX FROM ANY AND ALL CLAIMS ARISING
FROM THE USE OR OPERATION OF THE EQUIPMENT (OR THE FAILURE TO OPERATE OR
OTHER IMPROPER FUNCTIONING OF THE EQUIPMENT), OR ANY PART THEREOF, FROM
AND AFTER THE DATE HEREOF AND HEREBY INDEMNIFIES AND HOLDS HARMLESS
XXXXXXX FOR ANY AND ALL DAMAGES RESULTING FROM THE USE OR OPERATION OF THE
EQUIPMENT (OR THE FAILURE TO OPERATE OR OTHER IMPROPER FUNCTIONING OF THE
EQUIPMENT), OR ANY PART THEREOF, FROM AND AFTER THE DATE HEREOF,
INCLUDING, WITHOUT LIMITATION, ALL INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR
LOSS OF REVENUE OR PROFIT, LOSS OF USE OF THE EQUIPMENT, DOWNTIME COSTS OR
COST OF ANY SUBSTITUTE EQUIPMENT.
4. THIS AMENDMENT SHALL BE EFFECTIVE AS OF DECEMBER 20, 2000.
WITNESS, the signature of all parties hereto by their duly authorized officers.
XXXXXXX PHARMACEUTICA INTERNATIONAL
Represented by CILAG AG INTERNATIONAL
CILAG AG INTERNATIONAL
Xxxxxx + Xxx-Xxxxxxx 0
XX-0000 Xxx
/s/ X. Xxxxxxxx /s/ X. Xxxxxx
---------------------- -----------------------
(title) EXECUTIVE DIRECTOR OPERATIONS (title) GENERAL MANAGER
X. XXXXXXXX X. XXXXXX
ALKERMES CONTROLLED THERAPEUTICS INC. II
/s/ Xxxxx Xxxxxx /s/ Xxxxxxx Xxxxxxx
---------------------- ----------------------
(title) VICE PRESIDENT (title) VICE PRESIDENT
XXXXXXX PHARMACEUTICA PRODUCTS, L.P.
/s/ Xxxxxxx Xxxxxxx
---------------------- -----------------------
(title) (title) SECRETARY
EXHIBIT A
[***]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
