AVALONRX
®
LICENSE AGREEMENT
This
AvalonRx ® License
Agreement (
“Agreement” ) is made as of
October 27, 2008 (the “Effective Date”) by and
between Avalon
Pharmaceuticals, inc. , a Delaware corporation (
“AVRX” ), having an office at 20358
Seneca Meadows Parkway, Germantown, Maryland 20876, and
Clinical Data,
Inc. , a Delaware corporation (
“CLDA” ), having an office at One Gateway
Center, Suite 702, Newton, Massachusetts 02458. AVRX and CLDA
may each be referred to herein individually as a
“Party” and collectively as the
“Parties.”
Whereas , AVRX has developed
AvalonRx ® , a proprietary platform that uses polymerase
chain reaction (PCR), microarray technology, robotics and
bioinformatics to enable fast, fully-automated, large-scale
analysis of gene expression and its application to the discovery
and development of drugs (“AvalonRx”);
Whereas , CLDA is a company
engaged in the development and commercialization of targeted
therapeutics and predictive tests from a portfolio of proprietary
biomarkers;
Whereas , AVRX and CLDA wish
to enter into this Agreement to provide CLDA with perpetual,
irrevocable, and exclusive access to AvalonRx and AvalonRx
Technology (defined below), as more fully described herein;
and
Whereas, CLDA will be
entitled to retain all results it generates from use of AvalonRx,
subject to the terms and conditions of this Agreement.
Now, Therefore , in
consideration of the foregoing premises and the mutual promises,
covenants and conditions contained herein, AVRX and CLDA agree as
follows:
The following
capitalized terms shall have the meanings indicated for purposes of
this Agreement:
1.1
“Affiliate” shall mean any corporation, association
or other entity that directly or indirectly controls, is controlled
by or is under common control with the Party in question. As used
in this definition of “Affiliate,” the term
“control” shall mean having the power to direct or
cause the direction of the management and policies of an entity,
whether through direct or indirect beneficial ownership of more
than 50% of the voting or income interest in such corporation or
other business entity. Notwithstanding the foregoing, for purposes
of this Agreement, the term “Affiliate” shall not
include subsidiaries in which a Party or its Affiliates owns a
majority of the ordinary voting power to elect a majority of the
board of directors but is restricted from electing such majority by
contract or otherwise, until such time such restrictions are no
longer in effect.
1.
1.2
“AvalonRx Technology” shall mean: (a) all
discoveries, inventions, information, data, know-how, and trade
secrets (whether or not patentable) that are owned or in-licensed
by AVRX as of the Effective Date or thereafter and are used or
useful with or necessary to operate AvalonRx, including without
limitation (i) used or useful with or necessary for use of any
and all methods and devices comprising AvalonRx, (ii) used or
useful with or necessary for use of any hardware related to the
“High-throughput Integrated Transcriptional Screen”
system; (iii) used or useful with or necessary for use of any
hardware related to the “Rapid Assessment of Compound
Efficacy, Transcriptional Change and Kinetics” system; and
(iv) used or useful with or necessary for use of any hardware
related to the “Transcriptional
Structure-Activity-Relationship” system, and (b) all
data and information owned or in-licensed by AVRX as of the
Effective Date or thereafter and generated by or through the use of
AvalonRx or any other AvalonRx Technology, except data and
information as to which a Third Party has exclusive rights under an
agreement of Schedule A (as such agreement
exists on the Effective Date) and/or data and information with
respect to the Excluded Field that has no reasonable relevance
outside the Excluded Field, and (c) the Licensed Software
system, and (d) any AVRX Improvements; and (e) all Patent
Rights or other intellectual property rights owned or in-licensed
by AVRX as of the Effective Date or thereafter, to the extent they
cover any of the foregoing. Notwithstanding the foregoing, any
discoveries, inventions, information, data, know-how, trade
secrets, Patent Rights, or other intellectual property that is
licensed to AVRX by a Third Party (“ In-Licensed IP
”) shall be excluded from AvalonRx Technology if (A) the
applicable license agreement granting AVRX rights in such
In-Licensed IP imposes sublicensee obligations that are not
included in this Agreement, and (B) AVRX notifies CLDA in
writing of such obligations (which notification shall specifically
reference this Section 1.2), and (C) CLDA does not agree
to be bound by such obligations within thirty (30) days after
CLDA receives such written notification.
1.3
“AVRX Improvements” has the meaning set forth in
Section 2.3.
1.4
“CLDA Improvements” has the meaning set forth in
Section 2.4.
1.5
“CLDA Results” shall mean any results, data or
other information related to and/or generated by or for CLDA or its
Affiliates after the Effective Date through the use of AvalonRx and
AvalonRx Technology, including, but not limited to biomarker
signatures, small molecule library content, gene expression data
and information (whether or not in the form of a database), pathway
data and information, compound profiles, analog synthesis data and
information, disease models and quantitative data and
information.
1.6
“Control” shall mean possession of the ability to
grant the licenses or sublicenses or to make the assignments as
provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
1.7
“Effective Date” shall mean the date of this
Agreement first written above.
1.8
“Excluded Field” has the meaning set forth in
Section 3.3(a).
1.9
“Improvement” shall mean any enhancement or
improvement (whether or not patentable) to AvalonRx and/or the
AvalonRx Technology that is made by either Party or both Parties
using AvalonRx or the Licensed Software.
2.
1.10
“Licensed Software” shall mean all software used or
useful with AvalonRx or necessary to operate AvalonRx Technology,
including, but not limited to, the High-throughput Integrated
Transcriptional Screen (HITS), all compound profiling toolkits, all
software required to operate the Rapid Assessment of Compound
Efficacy, Transcriptional Change and Kinetics (RACETraCK) system,
any software necessary to conduct Transcriptional
structure-activity-relationships system (TSAR), to the extent that
such software is Controlled by AVRX as of the Effective
Date.
1.11
“Patent Rights” shall mean all rights associated
with all United States and foreign patents (including all reissues,
extensions, confirmations, registrations, re-examinations, and
inventor’s certificates) and patent applications (including,
without limitation, all substitutions, continuations,
continuations-in-part and divisionals thereof).
1.12
“Territory” shall mean all countries in the
world.
1.13
“Third Party” shall mean any party other than CLDA,
AVRX or their respective Affiliates.
2.
Development;
Commercialization; Intellectual Property
Rights
2.1
Development and Commercialization. Following the Effective
Date, subject to AVRX’s retained rights under
Section 3.3(a) and the excluded rights under
Section 3.3(b), CLDA shall have full control, authority, and
discretion over the research, development, and commercialization of
the AvalonRx and the AvalonRx Technology licensed to CLDA under
this Agreement.
2.2 Ownership
of CLDA Results. CLDA shall solely own all CLDA Results. CLDA
shall have no obligation to disclose to AVRX any CLDA Results or to
provide AVRX with notice of CLDA’s intent to file patent
applications thereon.
2.3 AVRX
Improvements. Subject to the licenses granted herein, AVRX
shall own all rights to the AvalonRx Technology and Improvements
thereto conceived or made by AVRX employees pursuant to the
excluded rights and AVRX’s retained rights set forth in
Section 3.3 (“ AVRX Improvements ”). AVRX
shall be responsible, in its sole discretion and at its sole cost,
for the filing, prosecution and maintenance of Patent Rights,
copyrights and other proprietary rights claiming or directed to
AvalonRx Technology and AVRX Improvements thereto.
2.4 CLDA
Improvements. To the extent that any Improvements to the
AvalonRx Technology are made by employees or agents of CLDA
(“ CLDA Improvements ”), CLDA shall own all
right, title and interest in and to such CLDA Improvements. CLDA
shall be responsible, in its sole discretion and at its sole cost,
for the filing, prosecution and maintenance of Patent Rights,
copyrights and other proprietary rights claiming or directed to
CLDA Improvements.
3.
Licenses; Technology
Transfer
3.1 AvalonRx
License to CLDA. Subject to the terms and conditions of this
Agreement, including, without limitation, payment under
Section 4.1, and subject to the rights retained by AVRX under
Section 3.3(a) and the excluded rights under
Section 3.3(b) AVRX
3.
hereby grants
to CLDA a royalty-free, fully-paid, worldwide, perpetual,
irrevocable, sublicensable, exclusive (even as to AVRX) license,
under the AvalonRx Technology, to use and exploit AvalonRx and the
AvalonRx Technology for any and all purposes. The licenses granted
herein under In-Licensed IP (as defined in Section 1.2) are
limited to the rights and licenses that are granted to AVRX and
that can be granted by AVRX to CLDA pursuant to the terms of such
in-licenses.
3.2
Sublicensing by CLDA. CLDA shall have the right to grant
sublicenses through multiple tiers under any or all of the rights
provided in Section 3.1 to its Affiliates and to Third
Parties, and CLDA shall not be required to obtain AVRX’s
consent to any such sublicenses. Each such sublicense shall be
consistent with the terms of this Agreement.
3.3 Retained
and Excluded Rights. (a) Notwithstanding the exclusive
license granted in Section 3.1, AVRX retains the
non-exclusive, non-sublicensable right under the AvalonRx
Technology to use and exploit AvalonRx and the AvalonRx Technology
for the sole purpose of (a) performing its obligations under
the agreements listed in Schedule A (as such
agreements exist on the Effective Date) and (b) continuing
development of AVN 944 and its existing development programs
directed against the following targets (without any material change
in focus or direction): beta-catenin, PLK3, myc, and survivin (the
“Excluded Field”).
(b) The
Parties acknowledge and agree that AVRX has may have granted or may
be obligated to grant a license to one or more Third Parties under
the AvalonRx Technology pursuant to the agreements listed in
Schedule A (as such agreements exist on the
Effective Date) (collectively, “ Existing Third Party
Licenses ”). Nothing in Section 3.1 is intended to
limit or otherwise modify such Existing Third Party Licenses or to
grant a license to CLDA that is inconsistent with the licenses
granted or that AVRX is obligated to grant under such Existing
Third Party Licenses, and the rights under the AvalonRx Technology
granted to CLDA under Section 3.1 shall be construed in such a
manner so as to preserve the scope and validity of such Existing
Third Party Licenses.
3.4 Third
Party Licenses . AVRX shall be solely responsible for all costs
and expenses of any licenses between a Third Party and AVRX or its
Affiliates related to the AvalonRx Technology, whether such
licenses exist on the Effective Date or AVRX or its Affiliates
enter into such licenses after the Effective Date.
3.5 Technology
Transfer. AVRX shall cooperate with CLDA and shall in a timely
manner provide access and provide to CLDA or any CLDA Affiliate
designated by CLDA any AvalonRx Technology licensed to CLDA that is
reasonably requested by CLDA, to the extent such AvalonRx
Technology is not already in CLDA’s possession. All costs and
expenses of any such cooperation and transfer by AVRX shall be
borne by AVRX. During the term of this Agreement, at no additional
cost to CLDA, AVRX shall provide CLDA with reasonable access by
teleconference or in person at AVRX’s facilities (subject to
AVRX’s customary rules and restrictions with respect to site
visits by non-AVRX personnel) to AVRX personnel having pertinent
knowledge for consulting advice with respect to AvalonRx and the
AvalonRx Technology.
4.
4.1 AvalonRx
Access Fee. In consideration of the licenses granted to CLDA
pursuant to Section 3.1, CLDA shall pay to AVRX a one-time
access fee of One Million U.S. Dollars (US$1,000,000)
simultaneously with the execution hereof.
4.2 Method of
Payment. All payments to be made under this Agreement to AVRX
shall be made in United States dollars in the United States to a
bank account designated by AVRX by wire transfer pursuant to the
instructions set forth on Schedule B
.
(a) AVRX shall be responsible for, at its sole expense, the
prosecution and maintenance of all Patent Rights included in the
AvalonRx Technology (the “ Licensed Patents ”).
AVRX shall deliver to CLDA copies of all documents materially
related to such prosecution or maintenance within a reasonable
period of time after such documents are prepared by or received by
AVRX, and in any event a reasonable amount of time before any such
document is filed with or submitted to the applicable patent office
or agency by AVRX. AVRX shall consult with CLDA regarding the
prosecution of any patent applications in the Licensed Patents
relating to the Territory, and shall incorporate any and all
reasonable comments or suggestions made by CLDA with respect to
such prosecution.
(b) If, at any time during the term of this Agreement, AVRX
no longer wishes to file, prosecute, or maintain any Patent Rights
in the Licensed Patents in the Territory, it shall notify CLDA in
writing of such decision. AVRX shall provide such notice at least
ninety (90) days prior to abandonment or lapse of such Patent
Rights, to the extent practicable in light of the timing of any
notice relating to such patent or patent application. Thereafter,
AVRX shall, if requested in writing by CLDA, assign its ownership
interest in such patent or patent application in such applicable
country or jurisdiction to CLDA for no additional consideration.
Upon such assignment, CLDA shall assume the sole and exclusive
responsibility, at its discretion, for the filing, prosecution,
and/or maintenance (as the case may be) of such patent or patent
application solely at its own expense.
5.2
Infringement by Third Parties .
(a) Notice. If either Party becomes aware of any actual
or threatened infringement of a Licensed Patent in the Territory,
such Party shall promptly notify the other Party in writing (the
“ Notice ”) and the Parties shall confer in good
faith regarding the most appropriate action to take with respect to
such infringement. Both Parties shall use their reasonable efforts
in cooperating with each other to terminate such infringement
without litigation.
(b) Enforcement. Unless the Parties otherwise agree,
CLDA shall have the first right, but not the obligation, to take
appropriate action in its own name and under its sole control
against activities allegedly infringing any Patent Right in the
Licensed Patents, to the extent such activities fall within the
scope of CLDA’s license in Section 3.1 (an
“Infringing
5.
Activity”). If CLDA does not take any
action against an Infringing Activity within one hundred eighty
(180) days after delivery of the Notice, then AVRX may, upon
thirty (30) days’ notice to CLDA and provided that CLDA
has not provided a commercially reasonable rationale for not taking
any action as to such an Infringing Activity, take appropriate
action against such an Infringing Activity in its own name and
under its sole control.
(c) Cooperation; Settlement . Regardless of which Party
brings the action (the “ Initiating Party ”),
the other Party (the “ Non-Initiating Party ”)
hereby agrees to cooperate reasonably in any such effort, all at
the Initiating Party’s expense, and the Parties shall
reasonably cooperate to address new facts or circumstances that
come to light during the course of any action relating to
the
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