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EXHIBIT 10.5
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.
THIRD AMENDMENT TO DEVELOPMENT AGREEMENT
SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT
FIRST AMENDMENT TO LICENSE AGREEMENTS
This Third Amendment amends the Development Agreement (the
"Development Agreement"), dated December
23, 1993, by and between Janssen
Pharmaceutica International, a division of
Cilag International AG, having its
place of business in CH-6300 Zug,
Switzerland ("JANSSEN") 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
Pennsylvania corporation, 64 Sidney Street,
Cambridge, MA 02139-4136, U.S.A. ("ACT II")
by a deed of assignment dated March
1, 1996.
This Second Amendment amends the Manufacturing and Supply
Agreement
(the "Manufacturing Agreement"), dated
August 6, 1997, by and between JANSSEN
and Janssen Pharmaceutica Inc., a New
Jersey corporation ("Janssen US") on the
one hand, and ACT II on the other hand.
This First Amendment amends both the License Agreement (the "US
License"), dated February 13, 1996, by and
between Janssen US and Medisorb,
which agreement has in the meantime been
duly assigned from Medisorb to ACT II
and the License Agreement (the "EX-US
License"), dated February 21, 1996, by and
between JANSSEN and Medisorb, which
agreement has in the meantime been duly
assigned from Medisorb to ACT II (both
licenses together referred to as the
"License Agreements").
WHEREAS, JANSSEN desires to evaluate the possibility of developing
a
* formulation of the Product and ACT II is
prepared to undertake such
feasibility study under the terms set forth
hereinafter.
NOW, THEREFORE, the parties, intending to be legally bound
hereby,
agree as follows:
All capitalised terms used herein shall have the meaning set
forth
in the Development Agreement, Manufacturing
Agreement or License Agreements, as
applicable, unless clearly indicated
otherwise. This agreement will be referred
to herein as this "Amendment".
1. ACT II and JANSSEN will undertake the activities set forth in
the
protocol for a * Product feasibility
attached to this Amendment as
Exhibit I (hereinafter "Protocol"). Such
activities will be undertaken in
accordance with the time and event schedule
specified in the Protocol with a
view to allow JANSSEN to evaluate candidate
formulations against the target
profile specified in the Protocol within a
12 month period following the
effective date of this Amendment.
2. JANSSEN will reimburse ACT II for the activities to be
undertaken
by it in accordance with the budget
provided for in the Protocol. ACT II will
invoice JANSSEN and JANSSEN will pay ACT II
within * following receipt of the
invoice.
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3. Following the internal analysis by JANSSEN of the various
formulations prepared by ACT II, JANSSEN
will promptly inform ACT II of its
decision whether or not it wants to proceed
with the development of a * Product.
In the event JANSSEN elects to proceed with
the further development, the parties
will immediately meet to discuss a full
development plan, including a time and
event schedule and related budget. Such
development plan sh
