Development Agreement [Amendment No. 2] - Janssen Pharmaceutica International, Medisorb Technologies International and Alkermes Controlled Therapeutics Inc. II
SECOND AMENDMENT
to the Development Agreement 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, 64 Sidney
Street, Cambridge, MA 02139-4136, U.S.A. ("ACT II") by a deed of assignment
dated March 1, 1996.
WHEREAS, JANSSEN and ACT II desire to amend certain terms of the
Development Agreement with respect to the continuation, management and further
funding of the Development Program.
NOW, THEREFORE, the parties agree to amend the Development Agreement as
follows:
1. In connection with Section 3 A., the Parties will undertake the
development activities set forth in the Development Plan attached to
this Amendment as Exhibit 1. Such activities will be undertaken in
accordance with the time and event schedule specified in the
Development Plan with a view to finalize the IRF within the timeframe
provided for in Section 4 A. of the Development Agreement. The
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Development Plan attached hereto cancels and supersedes the initial
Development Program referred to in Section 3A of the Development
Agreement.
2. Section 3 B. is hereby amended and replaced by the following:
The development activities to be undertaken hereunder will be
coordinated by a development team comprised of representatives of
JANSSEN or JANSSEN's Affiliates and ACT II (hereinafter "The
Development Team"). The Development Team will monitor and coordinate
all scaling up efforts in the preparation of the commercial
manufacturing process of the Product and all regulatory support
efforts in the preparation of the IRF and the subsequent regulatory
filings with national Health Authorities.
In the event that the Parties would consider additional activities to
be undertaken during the Development Program, such activities will be
discussed at the level of the Development Team, and, if such
activities are to be added to the Development Plan, a related budget
will be agreed
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by the Parties in accordance with the provisions of Section 3 D.
The Development team will meet at regular intervals as agreed by both
parties or upon the specific request of JANSSEN and at such locations
as JANSSEN shall determine, or, at the option of either party, through
video or telephone conferences. The Development Team shall endeavor to
resolve all matters by consensus, each party having one vote. If the
Development Team cannot reach an unanimous decision on any matter,
such matter shall be resolved based on and consistent with JANSSEN's
decision, it being understood that JANSSEN can not unilaterally change
the terms of this Agreement or the Budget related to the Development
Plan or decide that ACT II has to substantially increase its support
in addition to the efforts already committed by ACT II in accordance
with the current Development Plan.
3. Section 3 C. is hereby amended and replaced by the following:
ACT II will use reasonable efforts to comply with its commitments
under the Development Plan and
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will dedicate sufficient staff with sufficient skills to support its
efforts. ACT II will provide JANSSEN and JANSSEN's Affiliates
represented in the Development Team with a monthly written report
specifying the activities undertaken by it under the Development Plan.
ACT II will also create detailed descriptions of any methodology,
development formulation or processes related to development of Product
in order to enable JANSSEN to prepare and file any regulatory approval
and to assist in meetings with the regulatory authorities and to
enable JANSSEN and/or ACT II as the case may be, to prepare and start
up the commercial manufacturing process and the decision process
related thereto.
4. Section 3 D. is hereby amended and replaced by the following:
The parties have agreed on a budget in connection with the activities
to be undertaken by ACT II hereunder and such budget forms part of the
Development Plan (hereinafter "The Budget").
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The Budget includes all the estimated costs to be reimbursed by
JANSSEN to ACT II under the Development Plan, including the clinical
trial supplies up to and including Phase III clinical trials. In April
of each calendar year the Budget will be adjusted to the FTE (Full
Time Equivalent) rate for the next following Alkermes (being ACT II's
parent) fiscal year. Such FTE rate will be calculated by dividing the
total expenses of Alkermes (being ACT II's parent) by the number of
direct personnel. This personnel excludes G&A, finance, legal and
human resources. Prior to implementing such new FTE rate, JANSSEN and
ACT II will discuss the impact on the Budget of such new FTE-rate.
In the event that as a result of additional activities to be
undertaken by ACT II, the Budget would have to be revised, the parties
will agree on such revision prior to ACT II starting any such
activities.
The Budget provides for the purchase of the capital items specified in
Exhibit 2 attached hereto dedicated to the development of the Product
for a total amount 1,860,000 USD. Such capital
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items will be paid for by JANSSEN or its designee and ownership will
reside with JANSSEN or the designee who paid for such capital items.
Such capital items will be used by ACT II in its premises solely in
relation to the development and manufacture of Product as provided for
in the Development Plan and shall only be acquired after consultation
and approval of JANSSEN. ACT II will be responsible for the
maintenance of such capital items. All other capital items required by
ACT II to perform the activities provided for in the Development Plan
will be ACT II's obligation and responsibility.
Upon termination of the Development Agreement for any reason
whatsoever, the capital items paid for by JANSSEN or its designee will
be transferred to JANSSEN or its designee, at JANSSEN's cost.
ACT II will invoice JANSSEN on a monthly basis for the activities
undertaken by it during the previous month. Together with such
invoice, ACT II will send the monthly report detailing the efforts
expended under the Development Plan during such month. JANSSEN will
pay ACT II within thirty
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(30) days following receipt of the invoice and the related report.
This Second Amendment is deemed to be effective as from March 8, 1996.
Since both JANSSEN and Janssen Pharmaceutica Inc., 1125
Trenton-Harbourton Road, Titusville, NJ 08560, U.S.A., have exercised
the option to enter into a License Agreement provided for in Section
6(A) of the Development Agreement, as duly amend by the First
Amendment, Janssen Pharmaceutica Inc. will co-sign this Second
Amendment, to indicate its agreement with the terms thereof.
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WITNESS, the signature of all parties hereto by their duly authorized
officers.
JANSSEN PHARMACEUTICA
INTERNATIONAL
Date: April 28, 1997
/s/ Erik Rombouts /s/ Heinz Schmid
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(title) Division Manager (title) General Manager
International Trading
ALKERMES CONTROLLED
THERAPEUTICS INC. II
Date:
/s/ Michael Landine
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(title) (title) Vice President
JANSSEN PHARMACEUTICA INC.
Date:
/s/ Paulo F. Costa
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(title) (title) President
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