EPIX Medical, Inc. has omitted from this Exhibit 10.42 portions of the
agreement for which EPIX Medical, Inc. has requested confidential treatment from
the Securities and Exchange Commission. The portions of the agreement for which
confidential treatment has been requested are marked [*] and such confidential
portions have been filed separately with the Securities and Exchange Commission.
AMENDMENT NO. 1
This Amendment No. 1 dated as of September 10, 1998, is made by and
among EPIX MEDICAL, INC., a Delaware corporation having its principal place of
business at 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000 X.X.X.
("Epix"), MALLINCKRODT MEDICAL, INC., a Delaware corporation having its
principal place of business at 000 XxXxxxxxx Xxxxxxxxx, Xx. Xxxxx, Xxxxxxxx
00000, and MALLINCKRODT INC., (under its prior corporate name MALLINCKRODT GROUP
INC.) a New York corporation having its principal place of business at 0000
Xxxxxxx Xxxxxxxxx, Xx. Xxxxx, Xxxxxxxx 00000, by and through its unincorporated
Medical Imaging division (together with Mallinckrodt Medical, Inc., "MKG").
RECITALS
WHEREAS, Epix (under its prior corporate name Metasyn, Inc.) and MKG
are parties to a Strategic Collaboration Agreement dated as of August 30, 1996
(the "Collaboration Agreement"); and
WHEREAS, Epix and MKG desire to amend the Collaboration Agreement to
clarify the rights and obligations of the parties with respect to certain third
party arrangements, as set forth herein.
NOW THEREFORE, in consideration of the premises Epix and MKG mutually
agree as follows:
ARTICLE I. AMENDMENT
1. Epix and MKG hereby agree to amend Article 4 of the Collaboration Agreement
by adding the following new Section 4.8:
4.8 Collaboration Agreements with Third Parties:
4.8.1 General. In the event that either Party, during the term
of the Development Phase or thereafter, determines that a
research, development or collaboration agreement with a Third
Party would further the objectives of this Agreement (a "Third
Party Collaboration"), such Party (the "Collaborating Party")
shall so notify the Joint Steering Committee, which notice
shall include reasonable details concerning the terms of the
proposed Third Party Collaboration, including its objectives,
term, proposed budget, and the manner in which intellectual
property rights arising therefrom are to be made available to
the Collaborating Party. The Joint Steering Committee shall
make a determination as soon as practicable after such notice,
but in no event later than ninety (90) days thereafter, as to
whether to approve the proposed Third Party Collaboration,
Page 1 of 6
September 10, 1998
and to treat the costs of the Third Party Agreement (as
defined below) as Development Costs to be borne equally by the
parties hereunder.
4.8.2. Amendment to Development Plan and Budget. Upon approval
by the Joint Steering Committee of a Third Party
Collaboration, the current Development Plan and Budget will be
amended to reflect the additional anticipated costs of the
Third Party Agreement, and the Parties will share the costs
thereof as provided in Section 8.3.
4.8.3. Approval of Agreement and Any Amendments. Following
approval by the Joint Steering Committee of a Third Party
Collaboration, the Collaborating Party will proceed to
negotiate the definitive terms thereof, keeping the other
Party reasonably informed, will consider in good faith any
comments or suggestions of the other Party relating thereto,
and shall in any event obtain the written approval of the
other Party prior to executing the definitive agreement (the
"Third Party Agreement") or any material amendments thereto.
4.8.4. Sharing of Developments and Information. Following
execution of a Third Party Agreement as provided in Section
4.8.3, the Collaborating Party agrees, subject to the
confidentiality provisions hereof, to keep the other Party
regularly informed of all material developments under the
Third Party Agreement, including all reports, technical
information and data, and intellectual property rights arising
therefrom. Upon request of the other Party, to the extent
reasonably feasible, and subject in appropriate circumstances
to the other Party entering into agreements to be bound by
applicable terms of the Third Party Agreement, the
Collaborating Party will permit representatives of the other
Party to attend and participate in meetings with
representatives of the Third Party conducting the
collaboration.
4.8.5. Sharing of Intellectual Property Rights. The
Collaborating Party under any Third Party Agreement agrees
that the other Party will have a joint undivided interest in
any patent rights or other intellectual property rights
obtained by the Collaborating Party as a result of any Third
Party Agreement, and, upon request of the other Party, the
Collaborating Party agrees to execute and deliver to the other
Party any documents of assignment necessary to effect the
foregoing. Except as otherwise agreed, the Collaborating Party
will be responsible, in consultation with the other Party, for
the preparation, filing, prosecution and maintenance of any
patent applications or patents, the costs of which shall be
Development Costs to be shared by the Parties under Section
8.3.
4.8.6. Existing and Proposed Third Party Collaborations. The
Parties acknowledge that [*], Epix's agreement with the
General Electric Company ("GEC") dated as of January 9,
1998,
[*] Omitted portions filed separately with the Securities and Exchange
Commission.
Page 2 of 6
September 10, 1998
[*] are approved Third Party Agreements hereunder. [*] has not
yet been the subject of a formal notice pursuant to Section
4.8.1 above.
4.8.7. Failure to Accept a Third Party Collaboration. If the
Joint Steering Committee declines to approve a proposed Third
Party Collaboration under Section 4.8.1, the Collaborating
Party shall have the right to enter into the Third Party
Agreement at its own expense, and the other Party shall have
no right to any intellectual property or other rights arising
from such Third Party Agreement, except as otherwise provided
in this Agreement.
2. Epix and MKG hereby agree to amend Article 5 of the Collaboration Agreement
so that the following Sections are amended and restated, or added, to read in
their entirety as follows:
5.1. Additional Research Programs. In the event that either
Party, during the term of this Agreement, has what it believes
is a valid concept for discovering potential Second Generation
Compounds that are reasonably likely to have successful
commercial application, such Party shall promptly report such
concept to the Joint Steering Committee together with a
recommended specific research program pursuant to which any
such concept could be added to the Program. Such
recommendation shall include a proposed research plan and
budget and shall include details explaining why the
recommending party believes that the proposed concept could
lead to the discovery of Second Generation Compounds that may
have significant performance or other advantages over the
compounds ongoing Research Programs. The Joint Steering
Committee shall make a determination with respect to each such
recommendation as soon as practicable after such
recommendation is made but in no event later than ninety (90)
days. In the event that the Joint Steering Committee fails or
declines to approve any recommended research program as an
addition to the Program within the aforementioned ninety (90)
day period (or such longer period as the Parties may mutually
agree), then the Party which recommended such research program
shall be free to develop, market and sell any compounds
developed in such research program by itself, including with
the assistance of third party contractors, provided, however,
that any compounds developed in such research program [*].
If the Joint Steering Committee approves the recommended
research program as an addition to the Program, then the
research program may commence immediately in
[*] Omitted portions filed separately with the Securities and Exchange
Commission.
Page 3 of 6
September 10, 1998
accordance with the proposed research plan and budget. At such
time during the research program as either Party identifies a
specific potential Second Generation Compound for development,
such Party shall promptly report such compound to the Joint
Steering Committee together with a recommended specific
research plan and budget relating to the development of such
compound. The Joint Steering Committee shall make a
determination with respect to each such recommendation as soon
as practicable after such recommendation is made but in no
event later than ninety (90 days). If the Joint Steering
Committee approves the recommended research program for the
specific potential Second Generation Compound as an addition
to the Program, then the research program for such compound
may commence immediately in accordance with the proposed
research plan and budget. In the event that the Joint Steering
Committee fails or declines to approve any recommended
research program for the specific potential Second Generation
Compound as an addition to the Program within the
aforementioned ninety (90) day period (or such longer period
as the Parties may mutually agree) then the non-recommending
Party shall either [*].
5.1.1. Ongoing Research Programs. Epix and MKG acknowledge
that they are currently engaged in a single Research Program
under the Collaboration Agreement which relates to albumin
binding for second generation intravascular contrast agents,
which Research
[*] Omitted portions filed separately with the Securities and Exchange
Commission.
Page 4 of 6
September 10, 1998
Program is more fully described in correspondence between
Epix and MKG dated [*]. Unless otherwise agreed by Epix and
MKG, Epix and MKG agree that there shall be no more than [*]
Research Programs being conducted at any time. Unless
otherwise agreed by Epix and MKG, should a research program
concept be proposed and the Joint Steering Committee
recommend that such concept could be added to the Program
while [*] Research Programs are being conducted, any such
recommended Research Program shall be delayed until [*] the
ongoing Research Programs [*] been completed.
5.2.1. General. The Joint Steering Committee will determine
the allocation of responsibility between the Parties for the
conduct of each approved Research Program. Upon approval of a
Research Program, the Joint Steering Committee shall select a
Joint Scientific Team consisting of five (5) members, three
(3) from the recommending Party and two (2) from the
non-recommending Party, to direct the research. The Joint
Scientific Team shall issue a written progress report
quarterly and shall make an oral status presentation at each
meeting of the Joint Steering Committee. Each of the Parties
will attempt to achieve efficiently and expeditiously the
objectives assigned to it by the Joint Steering Committee as
described in the Annual Research Plan (defined below) and will
proceed diligently with the work described therein by using
its good faith efforts. The Joint Steering Committee shall
have the authority to mandate changes in the direction of the
Research Program or to mandate its discontinuance at any time.
3. Epix and MKG hereby agree to amend Article 8 of the Collaboration Agreement
so that the following section is amended and restated to read in its entirety as
follows:
8.3.5. Notwithstanding any other provision hereof, it is
understood that, without its prior written consent, neither
Party shall be liable to pay an amount in Development Costs
hereunder with respect to the Licensed Compound and any
Replacement Compounds and their corresponding Licensed
Products of more than [*].
4. Epix and MKG hereby agree to amend Article 13 of the Collaboration Agreement
so that the following section is amended and restated to read in its entirety as
follows:
13.2.4. Effect of Termination of the Research Program. In the
event that the Research Program is terminated with respect to
any compound pursuant to Section 13.2.2, then such compound
may not be designated as a Second Generation Compound or a
Replacement Compound by the Joint Steering Committee and
neither party, alone or with a Third Party, shall have the
right to develop a product for sale in the Field based upon
such compound; provided, however, that if the compound
demonstrates [*]
[*] Omitted portions filed separately with the Securities and Exchange
Commission.
Page 5 of 6
September 10, 1998
over any compound then in research or development or
being marketed or sold under the collaboration, then, in such
event, (a) all rights with respect to the use, manufacture,
distribution for sale and sale of such compound shall revert
to the Originating Party, except that, to the extent such
compound has been jointly acquired through license, purchase
or otherwise, both Parties will have the right to use,
manufacture, distribute for sale and sell such compound on a
nonexclusive basis, (b) to the extent legally permissible, all
additional action reasonably necessary shall be taken by the
Parties to assign all right, title and interest in and
transfer possession and control of the regulatory filings and
regulatory approvals relating to such compound and (c) the
Originating Party shall be free to develop or grant licenses
to Third Parties with respect to such compound. In the event
that the Originating Party enters into an agreement with a
Third Party pursuant to clause (c) hereof and such Third Party
will use data generated during the Program, then the
Originating Party shall provide in such agreement that such
Third Party shall reimburse the non-Originating Party for the
perceived value of such data, such value to be negotiated in
good faith by MKG and Metasyn taking into account the
financial contributions of both Parties to the generation of
such data.
ARTICLE 2 - MISCELLANEOUS
Except as expressly amended by this Amendment No. 1, the Collaboration
Agreement shall remain unmodified and in full force and effect. This Amendment
No. 1 may be executed in two or more counterparts, each of which shall be deemed
an original, but all of which together shall constitute one and the same
instrument. This Amendment No. 1 shall be governed and construed in accordance
with the laws of the State of New York without giving effect to the choice of
law provisions thereof.
IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 as of
the date set forth above.
EPIX MEDICAL, INC. MALLINCKRODT INC.
By: /s/ Xxxxxxx X. Xxxx By: /s/ Xxxxx X. Xxxxxxx
----------------------- ------------------------
Name: Xxxxxxx X. Xxxx Name: Xxxxx X. Xxxxxxx
Title: President and Chief Title: President, Imaging Group
Executive Officer
[*] Omitted portions filed separately with the Securities and Exchange
Commission.
Page 6 of 6
September 10, 1998
