Exhibit 10.1

 

Amendment No 4

 

AMENDMENT TO

LICENSE AND COLLABORATION AGREEMENT

 

THIS AMENDMENT TO LICENSE AND COLLABORATION AGREEMENT (this “Amendment”), is
entered into this 8th day of July, 2009 (the “Effective Date”) by and between
Santaris Pharma A/S, a Danish corporation, having its principal place of
business at Hørsholm, Denmark (“Santaris”), and Enzon Pharmaceuticals, Inc., a
Delaware corporation, having its principal place of business at Bridgewater, New
Jersey 08807 (“Enzon”). Santaris and Enzon may be referred to herein
individually as a “Party” or collectively, as the “Parties”.

 

BACKGROUND

 

WHEREAS, Enzon and Santaris entered into the License and Collaboration Agreement
dated July 26, 2006 (the “Agreement”); and

 

WHEREAS, the Agreement was amended by Amendment No. 1 dated 13th of June 2007,
Amendment No. 2 dated 25th of June 2007, and Amendment No. 3 dated 21st of
December 2007; and

 

WHEREAS, Enzon and Santaris desire to amend and restate certain provisions of
the Agreement.

 

NOW, THEREFORE, in consideration of the covenants and obligations expressed
herein and intending to be legally bound, and otherwise bound by proper and
reasonable conduct, the Parties agree as follows:

 

 

1.

Capitalized terms used herein and not otherwise defined shall have the meanings
given to them

in the Agreement.

 

 

2.

Section 8.1 (c) of the Agreement is hereby amended and restated in its entirety
as follows:

 

(c) In Respect of all LNA Compound Patents:

 

                (i)          Santaris and Enzon shall jointly own the right,
title and interest in and to all provisional and other priority LNA Compound
Patent applications regardless of inventorship; and without the need for any
further action by a Party and subject to the licenses granted hereunder.

 

                (ii)          At the time of filing of each international patent
application filed under the Patent Cooperation Treaty (a “PCT Application”), if
not already jointly owned, Santaris and Enzon shall jointly own the right, title
and interest in and to such PCT Application, regardless of inventorship; and
without the need for any further action by a Party and subject to the licenses
granted hereunder. Santaris agrees to assign, and herby does assign, such right,
title and interest in and to any LNA Compound Patents to Enzon so that Santaris
and Enzon shall jointly own such LNA Compound Patents. For clarity, such a PCT
Application shall be filed in both Santaris and Enzon names.

 

                (iii)          At the time each PCT Application enters the
national or regional phase in any

 

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country or region in the Santaris Territory, Enzon agrees to assign, and hereby
does assign, such right, title and interest in and to any such LNA Compound
Patent to Santaris so that Santaris shall own the entire right, title and
interest in and to such LNA Compound Patent in all countries in the Santaris
Territory.

 

                (iv)          At the time each PCT Application enters the
national or regional phase in any country or region in the Enzon Territory,
Santaris and Enzon shall continue to jointly own such LNA Compound Patent in all
countries in the Enzon Territory.

 

                (v)          Promptly after the Effective Date, Santaris shall
assign and hereby does assign, to Enzon such right, title and interest in and to
all existing LNA Compound Patents listed on Schedule 1.57 that are PCT
Applications or have entered the national phase in any country in the Enzon
Territory so that Santaris and Enzon shall jointly own such LNA Compound
Patents, except for those that have already entered the national or regional
phase in any country or region in the Santaris Territory so that Santaris shall
continue to own those LNA Compound Patents in the Santaris Territory.

 

                (vi)          If any given LNA Compound is not selected as a
Selected LNA Compound by the latest date required by the Agreement, Enzon agrees
to assign, and herby does assign, such right, title and interest in and to any
LNA Compound Patents covering such LNA Compound to Santaris.

 

                (vii)         Enzon discontinues all Development or
Commercialization activities of all Selected LNA Compounds claimed under an LNA
Compound Patent jointly owned by the Parties, Enzon shall then assign its
entire, right, title and interest in such LNA Compound Patent to Santaris.

 

                (viii)        Except to the extent permitted under Section 2.4
or with the prior written consent of Santaris, Enzon shall not assign, license,
grant, suffer, permit or otherwise transfer any license, rights, security
interest, lien or other encumbrance, or other interest of any kind in such LNA
Compound Patents (except in connection with an assignment pursuant to Section
14.8).

 

 

3.

Section 8.2 (c) of the Agreement is hereby amended and restated in its entirety
as follows:

 

(c) LNA Compound Patents. With respect to inventions made with no inventive
contribution by Santaris’ employees, Enzon shall initially file and prosecute
all provisional and other priority patent applications which at least shall be
filed in the United States. The parties shall jointly prepare the PCT
Applications derived from such provisional and other priority patent
applications and each of Santaris and Enzon shall have the right to approve the
initial filing of the PCT Applications. Enzon shall file, prosecute and maintain
such PCT Applications for the benefit of both Parties.

 

With respect to inventions made with inventive contribution by Santaris’
employees, Santaris shall initially file and prosecute all provisional and other
priority patent applications which at least shall be filed in the United States.
The parties shall jointly prepare the PCT Applications derived from such
provisional and other priority patent applications and each of Santaris and
Enzon shall have the right to approve the initial

 

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filing of the PCT Applications. Santaris shall file, prosecute and maintain such
PCT Applications for the benefit of both Parties.

 

At the time each such PCT Application enters the national or regional phase in
any country in the Santaris Territory, Santaris shall thereafter direct the
filing, prosecution (including any interferences, oppositions, reissuance, and
re-examinations) and maintenance of all LNA Compound Patents in countries in the
Santaris Territory.

 

At the time each such PCT Application enters the national or regional phase in
any country in the Enzon Territory, Enzon shall thereafter direct the filing,
prosecution (including any interferences, oppositions, reissuance, and
re-examinations) and maintenance of all LNA Compound Patents in countries in the
Enzon Territory.

 

The Party having the right to prosecute in accordance with the foregoing is
referred to as the “Prosecuting Party”. Prosecuting Party shall provide the
other Party promptly with copies of all patent applications, correspondences and
other communications relating to LNA Compound Patents to and from patent offices
and provide the other Party at least sixty (60) days to offer comments.
Prosecuting Party shall consider in good faith any comments the other Party may
have with regard to the preparation, filing, prosecution and/or maintenance of
the patent applications and patents related to such LNA Compound Patents.
Prosecuting Party shall provide the other Party, a reasonable time prior to
taking or failing to take action that would affect the scope or validity of
rights under any LNA Compound Patent (including substantially narrowing or
canceling any claim without reserving the right to file a continuing or
divisional application, abandoning any patent or not filing or perfecting the
filing of any patent application in any country), with notice of such proposed
action or inaction so that the other Party has a reasonable opportunity to
review and make comments, and take such actions as may be appropriate in the
circumstances. However, the foregoing three sentences shall not apply to the
prosecution of national or regional phase applications in the Santaris
Territory, except that Santaris shall keep Enzon informed of the material
progress of such prosecution and shall provide such documents and take such
actions as may be reasonably required to facilitate the prosecution of
corresponding Patents in the Enzon Territory.

 

The Parties and their patent counsel shall establish such procedures as may be
desired to carry out the mutual review and consultation procedure contemplated
under this Section 8.2 (c) without imposing unreasonable burdens and delays on
the prosecution of the LNA Compound Patents. If Enzon, as the Prosecuting Party,
determines not to file, prosecute, defend or maintain any LNA Compound Patent
(including failing to defend any interference or opposition proceedings) in any
country, and providing that no other patent applications or patents containing
the same claims are pending or issued in that same country, then Enzon shall
provide Santaris with thirty (30) days prior written notice of such
determination and Santaris shall have the right and opportunity to file,
prosecute, defend and/or maintain such patent or patent application at Santaris’
sole cost and expense.

 

 

4.

Except as set forth in this Amendment, the Agreement shall remain in full force
and effect.

 

 

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        5.   Resolution of all disputes arising out of or related to this
Amendment or the performance, enforcement, breach or termination of this
Amendment and any remedies relating thereto, shall be governed by and construed
under the substantive Laws of the State of New York, without regard to conflicts
of law rules that would provide for application of the Law of Jurisdiction
outside of New York. To the extent there is any such dispute, such dispute will
be handled in accordance with the procedures set forth in Section 13 of the
Agreement.

 

        6.  This Amendment may be executed in two or more counterparts
(including by facsimile or pdf file) each of which shall be deemed an original,
but all of which together shall constitute one and the same instrument.

 

                        IN WITNESS WHEREOF, the Parties have executed this
Amendment in duplicate originals by their proper officers as of the date and
year first above written.

 

SANTARIS PHARMA A/S   ENZON PHARMACEUTICALS, INC.           By: /s/ Søren
Tulstrup   By: /s/ Ivan Horak           NAME: Søren Tulstrup   NAME: Ivan Horak
TITLE: Chief Executive Officer   TITLE: Chief Science Officer           By: /s/
Maja Bojko   By: /s/ Paul Davit           NAME: Maja Bojko   NAME: Paul Davit
TITLE: Chief Financial Officer   TITLE: EVP Human Resources          

 

 

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