Exhibit 10
[*] indicates that a confidential portion of the text of this agreement has been
omitted. The non-public information has been filed separately with the
Securities and Exchange Commission.
Execution Version
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OMNIBUS AGREEMENT
dated as of October 8, 2004
by and among
XOMA LTD.,
a Bermuda company
and
XOMA (US) LLC,
a Delaware limited liability company
and
XOMA IRELAND LIMITED,
an Irish company
and
MILLENNIUM PHARMACEUTICALS, INC.,
a Delaware corporation
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OMNIBUS AGREEMENT
THIS OMNIBUS AGREEMENT (the "Agreement") is made as of October 8, 2004 (the
"Effective Date") by and among XOMA LTD., a Bermuda company ("XOMA Bermuda"),
XOMA (US) LLC., a Delaware limited liability company ("XOMA LLC"), XOMA Ireland
Limited., an Irish company ("XOMA Ireland") and MILLENNIUM PHARMACEUTICALS,
INC., a Delaware corporation (both on its own behalf and as successor in
interest to mHOLDINGS TRUST, "Millennium"). XOMA Bermuda, XOMA LLC and XOMA
Ireland are collectively referred to as the "XOMA Entities" and the XOMA
Entities and Millennium are collectively referred to as the "Parties" and each
as a "Party." Capitalized terms used and not otherwise defined herein shall have
the meanings set forth in the Development and License Agreement (as defined
below).
W I T N E S S E T H
WHEREAS, XOMA LLC, XOMA Ireland and Millennium are parties to a Development
and License Agreement, dated as of November 26, 2001 (the "Development and
License Agreement");
WHEREAS, XOMA Bermuda and Millennium are parties to an Investment
Agreement, dated as of November 26, 2001, as amended (the "Investment
Agreement");
WHEREAS, XOMA Bermuda and Millennium are parties to a Registration Rights
Agreement, dated as of November 26, 2001 (the "Registration Rights Agreement");
and
WHEREAS, the Parties desire to modify the Development and License Agreement
and terminate the Investment Agreement and make certain other agreements all as
more fully set forth and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
set forth herein, the Parties, intending to become legally bound, hereby agree
as follows:
ARTICLE I
MODIFICATION OF DEVELOPMENT AND LICENSE AGREEMENT
Section 1.1 Modification; Termination. Until XOMA LLC ceases to have any
obligations under this Article I, the Development and License Agreement shall
remain in effect as modified by this Agreement. In general, XOMA LLC's
development and funding obligations under Article II of the Development and
License Agreement shall be limited to those specified in Section 1.2 below, the
licenses granted in Article IV of the Development and License Agreement shall be
limited to those necessary for the performance of responsibilities in accordance
with the terms and conditions of this Agreement, Millennium's payment
obligations under Article V of the Development and License Agreement shall be
limited to those provided in Section 1.3 below and XOMA LLC's supply obligations
under Article VI of the Development and License Agreement shall be limited to
amounts necessary to carry out its responsibilities under this
Article I. Upon completion of XOMA LLC's responsibilities under this Article I,
subject to the terms and except as set forth herein, the Development and License
Agreement shall terminate.
Section 1.2 Continuing Development Work. As provided under the Development
and License Agreement, XOMA LLC is currently conducting a phase I clinical trial
(the "Phase I Trial") of CAB-2 under Protocol No. MLN0750 (the "Protocol"). The
Parties agree that XOMA LLC will continue to prosecute the Phase I Trial through
completion of the Phase I Trial as provided herein. Specifically, the Parties
agree that the parameters of the Phase I Trial agreed to by the Joint Project
Team shall be [*]. Additional dosage cohorts may be added at Millennium's
request up to and including [*] via protocol amendment. The Parties hereby
reaffirm that the objective of the Phase I Trial in CABG patients is to escalate
the dose until [*] unless dose limiting toxicities preclude further dose
escalation. The Parties further agree that if a dosage of [*] or less achieves
the complement inhibition target, then an amended protocol will specify the
total number of additional patients to be treated at that dosage.
XOMA LLC will take all commercially reasonable actions necessary to amend
the Protocol in order to reflect the changes to the structure of the Phase I
Trial as set forth herein.
XOMA LLC and Millennium will further discuss in good faith the likely
necessity of adding alternative and/or additional sites to the Phase I Trial in
order to complete the study within a reasonable time frame.
All of the Development Costs and Manufacturing Costs of the Phase I Trial
shall be borne by XOMA LLC through completion of the Phase I Trial as described
above, including finalization of all required reports; provided, that in the
event Millennium requests that the Phase I Trial include more than the total
number of patients referred to above and XOMA agrees, then Millennium will
reimburse XOMA for all Development Costs and Manufacturing Costs relating to
such additional patients.
Section 1.3 Continuing Financial Considerations. Millennium agrees to make
the following royalty, milestone and other payments to the XOMA Entities
(notwithstanding any termination of the Development and License Agreement):
(a) Royalties: [*]% of all Net Sales of the Licensed Product (as
defined below) [*] and [*]% of all Net Sales of the Licensed Product [*],
in each case until [*] after the First Commercial Sale of the Licensed
Product [*], as applicable.
(b) Milestone Payments:
Upon start of Phase III Clinical Trials for the Licensed Product:
$[*]
Filing of BLA for the Licensed Product [*]: $[*]
First Approval of such Licensed Product [*]: $[*]
(c) Third Party Upfront License Fee: Section 5.1(b) of the Development
and License Agreement shall remain in force and effect, provided however
that the percent-
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age payment obligation referenced therein shall be [*] and the payment
obligation thereunder is extended to all upfront license fees [*].
Because XOMA LLC, XOMA Ireland and Millennium previously terminated the
Development and License Agreement with regard to LDP-01, for purposes of this
Agreement and any payment obligations hereunder (including, but not limited to,
this Section 1.3 and Section 1.5 below), the definition of "Licensed Product" as
contained in the Development and License Agreement is hereby amended to exclude
any reference to LDP-01. Further, Sections 5.6 and 5.7 and Article IX of the
Development and License Agreement shall apply, as appropriate, to any payments
made hereunder.
Section 1.4 Consequences of Termination. Upon termination of the
Development and License Agreement as set forth in Section 1.1 above, Section
12.5 of the Development and License Agreement shall apply and, as of the date of
such termination, XOMA LLC shall take all commercially reasonable actions
necessary to effect the transfers, grants and returns set forth thereunder. For
the avoidance of doubt, (a) it is understood that this Agreement does not, and
such termination shall not, represent or constitute a termination of the
Development and License Agreement by any party thereto for default, failure or
breach by any other party, and (b) the licenses referred to in Section 4.4 and
clause (b) of Section 12.5 of the Development and License Agreement shall
additionally extend to any Patent Rights and Know-How invented or developed
before or after the Effective Date.
Section 1.5 Certain Rights and Obligations. XOMA Bermuda hereby agrees to
seek, on behalf of XOMA Technology Ltd. ("XOMA Technology"), any consents
necessary for the assignment by XOMA Technology to Millennium and the assumption
by Millennium of all of XOMA Technology's rights and obligations relating to the
Licensed Product under that certain Non-Exclusive License Agreement [*]
Agreement") and, in the event such consents are granted, to effectuate such
assignment and assumption. Pending receipt of such consents and if for any
reason such assignment and assumption is deemed invalid, XOMA Bermuda hereby
agrees to provide, through XOMA Technology, a sublicense under the [*] Agreement
relating to the Licensed Product pursuant to and in accordance with Section 2.2
thereof and Millennium agrees to assume all obligations relating to the Licensed
Product of XOMA Technology thereunder. XOMA Bermuda and Millennium further agree
to take any and all further actions reasonably necessary to effect such
assignment or sublicense.
ARTICLE II
TERMINATION OF THE INVESTMENT AGREEMENT
Section 2.1 Termination of the Investment Agreement. As of the Effective
Date, XOMA Bermuda and Millennium hereby terminate the Investment Agreement
pursuant to Section 6.1(a) of the Investment Agreement; provided however, that
Article VII of the Investment Agreement shall remain in full force and effect as
set forth in the Investment Agreement.
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ARTICLE III
TERMS OF CONTRACT MANUFACTURING AGREEMENT
Section 3.1 Terms of Manufacturing Services Agreement. XOMA LLC and
Millennium agree to negotiate in good faith and as expeditiously as possible,
appropriate agreements for XOMA LLC to continue performing the following
manufacturing services for Millennium or its designee:
(a) XOMA LLC will produce [*] any reasonable quantities of bulk drug
substance needed by Millennium for Millennium and/or its designee to
conduct phase II trials for the Licensed Product. Millennium will reimburse
XOMA LLC for these services on a [*] basis as calculated in accordance with
U.S. generally accepted accounting principles; provided, however, that with
regard to the [*], Millennium will either: (i) purchase the [*] directly
for use by XOMA or (b) agree to reimburse XOMA LLC for any unused portion
of "[*]" initially and reasonably purchased by XOMA LLC to perform such
services.
(b) Second, XOMA LLC will develop [*]. At Millennium's request and
sole expense, XOMA LLC will file a patent application on any patentable
invention directed solely to such [*] and thereafter assign such patent
application to Millennium and will provide any reasonable assistance to
Millennium in prosecuting any such patent application. In addition, XOMA
LLC will agree not to publish any such patentable invention(s) prior to the
filing of a patent application relating thereto without Millennium's prior
written consent (not to be unreasonably withheld). In the event Millennium
decides to continue development of the Licensed Product using such [*],
XOMA LLC and Millennium will negotiate in good faith a development
agreement providing for the [*].
(c) Finally, with no obligation, in the future, Millennium will
consider XOMA LLC to manufacture the Licensed Product for phase III
clinical trials and commercial use.
ARTICLE IV
CONFIRMATION OF REGISTRATION RIGHTS AGREEMENT
Section 4.1 Confirmation of the Registration Rights Agreement. XOMA Bermuda
and Millennium agree that the Registration Rights Agreement shall remain in full
force and effect with respect to any Registrable Securities (as such term is
defined therein) issued prior to the Effective Date to Millennium.
ARTICLE V
MISCELLANEOUS
Section 5.1 Publicity. The Parties hereby agree to the release of a press
release in the form attached hereto as Schedule 5.1 upon full execution of this
Agreement and that the consummation of this Agreement, as well as such terms as
are expressly described in such press
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release, shall be deemed to be in the public domain. Each Party understands that
this Agreement is likely to be of significant interest to investors, analysts
and others and, thus, that any Party shall have the right to make future
announcements with respect to developments under this Agreement. The Parties
agree that any such announcement shall not contain confidential technical or
business information or, if disclosure of confidential technical or business
information is required by law or regulation, shall make reasonable efforts to
minimize such disclosure and obtain confidential treatment for any such
information which is filed with a government agency. Each Party agrees to
provide the other Parties with a copy of any such public announcement as soon as
reasonably practicable prior to its scheduled release, but in any event no less
than three (3) business days prior to its scheduled release, unless legal
requirements do not permit such prior notice. Each Party shall have the right to
expeditiously review and recommend changes to any such announcement, provided
that such right of review and recommendation shall only apply for the first time
that specific information is disclosed and shall not apply to the subsequent
disclosure of substantially similar information that has been previously
disclosed. Except as otherwise required by law, the Party whose announcement has
been reviewed shall delete any information the reviewing Parties reasonably deem
inappropriate for disclosure.
Section 5.2 Force Majeure. No failure or omission by the Parties in the
performance of any obligation of this Agreement shall be deemed a breach of this
Agreement or create any liability if the same shall arise from any cause or
causes beyond the control of the Parties, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued by any governmental authority or by any officer,
department, agency or instrumentality thereof; fire; flood; storm; earthquake;
accident; war; rebellion; insurrection; riot; and invasion and provided that
such failure or omission resulting from one of the foregoing causes is cured as
soon as is practicable after its occurrence.
Section 5.3 Consequential Damages. No Party shall be liable under this
Agreement for special, incidental or consequential damages or for loss of profit
or lost revenue, even if advised of the possibility of such damages.
Section 5.4 Assignment. Neither this Agreement nor any of the rights or
obligations hereunder may be assigned by any Party without the prior written
consent of the other Parties (not to be unreasonably withheld), except to a
party who acquires all or substantially all of the business of the assigning
Party to which the subject matter of this Agreement applies by merger, sale of
assets or otherwise.
Section 5.5 Section 365(n) of the United States Bankruptcy Code. All rights
and licenses granted under or pursuant to any section of this Agreement are and
shall otherwise be deemed to be for purposes of Section 365(n) of the United
States Bankruptcy Code (Title 11, U.S. Code), as amended (the "Bankruptcy
Code"), licenses of rights to "intellectual property" as defined in Section
101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise
all of their respective rights and elections under the Bankruptcy Code. Upon the
bankruptcy of any Party, the non-bankrupt Parties shall further be entitled to a
complete duplicate of, or complete access to, any such intellectual property,
and such, if not already in its possession, shall be promptly delivered to the
non-bankrupt Parties, unless the bankrupt Party elects to continue, and
continues, to perform all of its obligations under this Agreement.
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Section 5.6 Notices. Notices to Millennium shall be addressed to:
Millennium Pharmaceuticals, Inc.
00 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000 X.X.X.
Attention: Legal Department - General Counsel
Facsimile No.: (000) 000-0000
Notices to XOMA LLC shall be addressed to:
XOMA (US) LLC
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000 X.X.X.
Attention: Legal Department - General Counsel
Facsimile No.: (000) 000-0000
Notices to XOMA Bermuda shall be addressed to:
XOMA LTD.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000 X.X.X.
Attention: Legal Department - General Counsel
Facsimile No.: (000) 000-0000
Notices to XOMA Ireland shall be addressed to:
XOMA Ireland Limited
Xxxxxxx Airport House
Shannon, County Clare
Ireland
Attention: Secretary
Facsimile No.: 011-353-61-472060
with copies (which shall not constitute notice) to:
Xxxxxx Xxxxxx & Xxxxxxx LLP
Eighty Pine Street
New York, New York 10005
Attn: Xxxxxxxx X. Xxxxxxxx
Xxxxxxxxx No.: 212 269-5420
Any Party may change its address by giving notice to the other Parties in the
manner provided in this Section 5.6. Any notice required or provided for by the
terms of this Agreement shall be in
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writing and shall be (a) sent by certified mail, return receipt requested,
postage prepaid, (b) sent via a reputable overnight courier service, (c) sent by
facsimile transmission or (d) delivered by hand. The effective date of the
notice shall be the actual date of receipt by the receiving Party.
Section 5.7 Independent Contractors. It is understood and agreed that the
relationship among the Parties is that of independent contractors and that
nothing in this Agreement shall be construed as authorization for any Party to
act as the agent for any other Party.
Section 5.8 Governing Law. This Agreement shall be governed and interpreted
in accordance with the substantive laws of the State of New York notwithstanding
the provisions governing conflict of laws under such law of the State of New
York to the contrary, provided that matters of intellectual property law shall
be determined in accordance with the national intellectual property laws
relevant to the intellectual property in question.
Section 5.9 Severability. In the event that any provision of this Agreement
is held by a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any law of the relevant jurisdiction, the validity
of the remaining provisions shall not be affected and the rights and obligations
of the Parties shall be construed and enforced as if the Agreement did not
contain the particular provisions held to be unenforceable, provided that the
Parties shall negotiate in good faith in modification of this Agreement with a
view to revising this Agreement in a manner which reflects, as closely as is
reasonably practicable, the commercial terms of this Agreement as originally
signed.
Section 5.10 No Implied Waivers. The waiver by any Party of a breach or
default of any provision of this Agreement by another Party shall not be
construed as a waiver of any succeeding breach of the same or any other
provision, nor shall any delay or omission on the part of any Party to exercise
or avail itself of any right, power or privilege that it has or may have
hereunder operate as a waiver of any right, power or privilege by such Party.
Section 5.11 Entire Agreement. This Agreement and, to the extent set forth
herein, the Development and License Agreement, the Investment Agreement and the
Registration Rights Agreement constitute the entire agreement among the Parties
with respect to subject matter hereof and thereof and supersede all previous
written or oral representations, agreements and understandings among the
Parties, including, without limitation, any confidentiality agreement among the
Parties. This Agreement may be amended only by a writing signed by all Parties.
Section 5.12 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original, and all of which
together shall constitute one and the same instrument.
[The remainder of this page has intentionally been left blank.]
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IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by
its duly authorized representative as of the day and year first above written.
XOMA LTD.
By:
-----------------------------------
Name:
Title:
XOMA (US) LLC
By:
-----------------------------------
Name:
Title:
XOMA IRELAND LIMITED
By:
-----------------------------------
Name: Xxxx Xxxx
Title: Director
duly authorized for and on behalf of
XOMA Ireland Limited in the presence of:
MILLENNIUM PHARMACEUTICALS, INC.
By:
-----------------------------------
Name:
Title:
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