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EX-10.21
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
INDIANA UNIVERSITY RESEARCH AND TECHNOLOGY
CORPORATION
LICENSOR
AND
ANDARA LIFE SCIENCE, INC.
LICENSEE
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
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INTRODUCTION: This Exclusive License Agreement ("Agreement") is
made and entered
into on the Effective Date by and between the Indiana University
Research and
Technology Corporation., a nonprofit corporation organized under
the laws of the
state of Indiana, having its principal offices at 351 West 10th
Street,
Indianapolis, Indiana 46202 (hereinafter "IURTC"), and Andara Life
Science,
Inc., a corporation organized under the laws of the State of
Indiana, having its
address at 6640 Intech Boulevard, Suite 120, Indianapolis, IN 46278
(hereinafter
"ANDARA")
1
BACKGROUND: Through a Memorandum of Agreement between Indiana
University
("IU") and the Advanced Research and Technology Institute ("ARTI"),
the
predecessor corporation to IURTC, dated January 1, 1997, IU assigns
its
intellectual property to IURTC and IURTC is responsible for
managing the
intellectual property through its Office of Technology Transfer.
IURTC is
the
owner of certain Patent Rights and Technical Information
(collectively,
Intellectual Property) that are the subject of this Agreement and
has the
right to grant licenses. IURTC wishes to allow the Intellectual
Property to
be
used to further scientific research and for new product development
and
other applications in the public interest and is willing to grant a
license
for
such uses. ANDARA represents to IURTC that it has or has a good
faith
intention to develop or acquire the necessary product
development,
manufacturing, and marketing capabilities to commercialize products
based
on
such Intellectual Property. ANDARA desires to obtain a license to
use
these properties and information for its own commercial research
and
development endeavors upon the terms and conditions set forth in
this
Agreement. In consideration of these premises and the mutual
promises
contained herein, the Parties further agree as follows.
2
DEFINITIONS: For the purposes of this Agreement, the following
words and
phrases will have the meanings assigned to them below.
2.1
ANDARA: Andara Life
Science, Inc. and its affiliates. For the purpose
of this definition, affiliate is any person or entity that,
directly
or indirectly, owns or controls a Party or that is controlled by
or
under common control with a Party. "Control(s)" or "controlled
by"
means (a) direct or indirect ownership of at least 50% of the
outstanding voting securities of a corporation, (b) the right
to
receive at least 50% of the earnings of the person, corporation,
or
other entity in question, or (c) the right to control the
business
decisions of the person, corporation, or other entity in
question.
2.2
Combination Product:
Any product that is comprised of a Licensed
Product and one or more components which are not themselves
Licensed
Products.
2.3
Confidential
Information: shall mean any information of a technical,
scientific or commercial character which is proprietary to one of
the
Parties hereto or is otherwise in the legitimate possession of
such
party under an obligation of confidence, and which is
confidential
and/or not generally available from public sources, and includes
any
and all documents, electronic data, plans, photographs, apparatus
and
samples containing such information. Information that is
assembled
from a variety of public sources by use of Confidential Information
to
guide a search of such sources, shall also be deemed
Confidential
Information.
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
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2.4
Development Plan:
ANDARA's good faith, bona fide plan for the
development, manufacture, promotion, importation, sale and/or
marketing of Licensed Products.
2.5
Effective Date: July
29, 2005.
2.6
Field: * * *
2.7
First Commercial Sale:
The earliest date on which ANDARA or any of its
Sublicensees transfers a Licensed Product for compensation
(including
equivalent cash value for trades or other non-cash payments).
The
transfer of Licensed Products by ANDARA or its Sublicensees
strictly
for their own laboratory research and development purposes,
beta-testing and/or clinical testing does not constitute a
First
Commercial Sale for the purposes of this Agreement, provided
that
ANDARA or its Sublicensees receive no payment or other compensation
or
value for such Licensed Product in excess of the fully burdened
(i.e.,
direct and indirect) costs of producing and transporting such
materials.
2.8
Intellectual Property:
Collectively, all Patent Rights and Technical
Information.
2.9
Licensed Product: Any
product made, made for, used, sold or imported
by ANDARA or any Sublicensees that: (a) in the absence of this
Agreement would infringe at least one Valid Claim, or (b) uses
a
process covered by a Valid Claim. Licensed Product also includes
any
product made, and/or method or process used, in whole or in
part,
using or otherwise derived from Technical Information.
2.10
Party: IURTC or ANDARA. Collectively, IURTC and ANDARA may be
referred
to as the "Parties."
2.11
Patent Rights: IURTC's interest in the patents and patent
applications
listed in Exhibit A, attached hereto and incorporated by
reference
herein, and all foreign counterparts, continuations,
continuations-in-part, divisions, extensions, reexaminations
and
reissues thereof, whether filed on, before, or after the
Effective
Date, which trace their earliest priority filing date by
unbroken
lineage to a patent or patent application listed in Exhibit A, or
to a
patent or patent application from which a patent or patent
application
listed in Exhibit A claims priority.
2.12
Sublicensee: A person or entity to whom ANDARA has granted a
sublicense pursuant to and in accordance with Article 3 of this
Agreement.
2.13
Technical Information: All ideas, data, know-how, trade
secrets,
research information, methods, procedures or processes,
technical
information, copyrights and renewals, designs, drawings,
specifications, manufacturing methods owned by IURTC, that are
necessary or useful for the practice of the Patent Rights or for
the
commercialization of one or more Licensed Products, including
the
Technical Information identified in Exhibit B attached hereto
and
incorporated by
reference herein. Delivery of the Technical
Information will commence thirty (30) days after the Effective Date
of
this Agreement.
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
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2.14
Term: Commencing on the Effective Date and, unless earlier
terminated
in accordance with this Agreement, continuing for the greater of
(a)
ten (10) years, or (b) until the expiration of the last to
expire
patents in the Patent Rights.
2.15
Territory: Anywhere in the world, except those countries to
which
export of technology or goods is prohibited by applicable U.S.
export
control laws or regulations.
2.16
Valid Claim: A claim (a) of a pending Patent Rights patent
application
that has not been pending for longer than seven years, or (b) of
an
issued and unexpired Patent Rights patent that has not been
held
invalid or unenforceable by a court or other governmental agency
of
competent jurisdiction in a decision or order that is not subject
to
appeal.
3 LICENSE
GRANT: Subject to the terms and conditions set forth in this
Agreement, IURTC hereby grants to ANDARA and ANDARA hereby accepts,
the
following license during the Term in the Territory:
3.1
An exclusive,
fee-bearing, royalty-free license, including the right
to grant sublicenses as set forth herein, under the Patent Rights,
to
make, have made, sell, offer for sale, have sold, use, import and
have
imported Licensed Products in the Field.
3.2
An exclusive,
fee-bearing, royalty-free license, including the right
to grant sublicenses as set forth herein, under the Technical
Information, to make, have made, sell, offer for sale, have sold,
use,
import, and have imported Licensed Products in the Field.
3.3
ANDARA may grant
sublicenses under this Agreement only in strict
compliance with the following terms and conditions:
3.3.1 Only ANDARA is permitted to grant sublicenses. Any
sublicense
granted by ANDARA under this Agreement shall provide that
Sublicensees:
3.3.1.1 Indemnify and hold harmless IURTC Indemnitees (as
defined
in Article 11) to the same extent and under terms no less
favorable to IURTC Indemnitees as ANDARA's obligations under
Article 11 of this Agreement.
3.3.1.2 Maintain insurance for IURTC's benefit to the same
extent
and under terms no less favorable to IURTC as ANDARA's
obligations under Article 12 of this Agreement.
3.3.1.3 Comply with ANDARA's Development Plan referred to in
Article 4 of this Agreement if the sublicense includes joint
development of Licensed Products.
3.3.1.4 Will automatically become direct licensees of IURTC
under
the rights originally sublicensed to it by ANDARA if this
Agreement is terminated prior to expiration, provided that
(i) the Sublicensee did not cause the termination of this
Agreement and (ii) the Sublicensee agrees to comply with all
the terms of this Agreement and to fulfill all the
responsibilities of ANDARA hereunder. In no event, however,
shall a person or entity who becomes a direct licensee
pursuant to this provision have any right to grant
sublicenses
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
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under this Agreement. Sublicensing agreements will remain in
effect if this Agreement is terminated prior to expiration.
3.3.2 Within thirty (30) days of the effective date of any
sublicense,
ANDARA shall provide IURTC a complete copy of the sublicense
and
all exhibits thereto. If the original sublicense is written in
a
language other than English, the copy of the sublicense and all
exhibits thereto shall be accompanied by a complete translation
written in English. ANDARA represents and warrants that such
translation will be a true and accurate translation of the
sublicense agreement and its exhibits.
3.3.3 ANDARA will be primarily liable to IURTC for all of
ANDARA's
obligations contained in this Agreement. Any act or omission by
a
Sublicensee that would be a breach of this Agreement if imputed
to ANDARA will be deemed to be a breach by ANDARA of this
Agreement.
3.4
The license "to have
made" granted in Articles 3.1 and 3.2 means that
ANDARA may contract with one or more third parties to
manufacture
Licensed Products for ANDARA for sale or offer for sale by ANDARA
or
Sublicensees within the scope of its (or their) sales
operations.
ANDARA shall require all such third parties to assume
confidentiality
obligations consonant with Article 7 of this Agreement.
3.5
IURTC and IU may use
the Patent Rights for internal, non-commercial
educational and research purposes.
3.6
Nothing in this
Agreement shall restrict IU and its faculty, staff,
students, or employees from publishing the results of their
research
related to the patent applications or patents in the Patent
Rights.
3.7
This Agreement
provides ANDARA and Sublicensees no ownership rights of
any kind in the Intellectual Property. All ownership rights remain
the
property of IURTC. The delivery of Technical Information and the
grant
of license rights thereto under this Agreement do not constitute
a
sale of the same.
3.8
In accordance with
Public Laws 96-517, 97-256 and 98-620, codified at
35 U.S.C. Sections 200-212, the United States government
retains
certain rights to inventions arising from federally supported
research
or development. Under these laws and implementing regulations,
the
government may impose requirements on such inventions. Licensed
Products embodying inventions subject to these laws and
regulations
sold in the United States must be substantially manufactured in
the
United States. The license rights granted in this Agreement are
expressly made subject to these laws and regulations as they may
be
amended from time to time. ANDARA shall be required to abide by
all
such laws and regulations and shall ensure that all sublicenses
under
this Agreement impose a similar requirement upon all
Sublicensees.
3.9
ANDARA shall ensure
that appropriate markings, such as "Patent
Pending" or the Patent Rights patent number or application
serial
number, appear, in accordance with
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
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each
country's patent laws, on all Licensed Products (or their
packaging, as appropriate) sold by or on behalf of ANDARA and
all
Sublicensees.
4
DILIGENCE: ANDARA agrees to use commercially reasonable efforts to
develop,
manufacture, promote and sell Licensed Products in accordance with
the
Development Plan. ANDARA also agrees that it will require its
Sublicensees
to
comply with the standards and obligations of ANDARA set forth
herein.
4.1
Within ninety (90)
days of the Effective Date of this Agreement,
ANDARA will provide IURTC with a Development Plan that contains
ANDARA's good faith, bona fide plans for commercializing
Licensed
Products as rapidly and extensively as reasonably practicable.
The
Development Plan will include:
4.1.1 A definition of each Licensed Product planned for
development.
4.1.2 Tasks to be performed by ANDARA, its contractors and/or
Sublicensees to develop each Licensed Product to the point of
commercialization, including a good faith estimate of the time
schedules for specific tasks to be accomplished.
4.1.3 Identification of the primary country(ies) in which the
Licensed
Product(s) will be sold and a good faith estimate of time of
First Commercial Sale in the primary country(ies).
4.2
ANDARA will report
progress against the Development Plan in writing to
IURTC no later than July 31 of each calendar year following the
calendar year in which the Effective Date falls. All such
reports
shall be considered the Confidential Information of ANDARA.
4.3
Prior to the First
Commercial Sale of each Licensed Product, ANDARA
will be considered diligent developing each Licensed Product so
long
as ANDARA * * *:
4.3.1 * * *
4.4
After the First
Commercial Sale, ANDARA will be considered diligent if
* * *.
4.5
If, at any time after
* * * from the Effective Date, IURTC should
conclude in its reasonable judgment that ANDARA has not been
diligent
pursuant to any provision of this Article 4, for reasons other
than:
(a) a governmental agency has withheld regulatory approval
notwithstanding ANDARA's diligent efforts to obtain such approval;
(b)
ANDARA encountered unanticipated technical or scientific problems
that
have been promptly reported in writing to IURTC; or (c) ANDARA
encountered other causes beyond its reasonable control,
notwithstanding its diligent efforts to overcome them, and which
have
been promptly reported in writing to IURTC; then IURTC may
notify
ANDARA of its conclusions and the bases therefor and, upon request
of
IURTC, ANDARA must show cause why the license granted hereunder
should
not be terminated. If within * * * after IURTC's service of notice
on
ANDARA the Parties have not resolved the matter through good
faith
negotiations, IURTC may immediately terminate the license
granted
hereunder.
*** Information
redacted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the
Commission.
6
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5 FEES AND
PAYMENTS
5.1
As full consideration
for the grant of rights in Articles 3.1, 3.2 and
3.3, ANDARA shall issue to IURTC * * * common shares, without
par
value, of ANDARA (collectively, the "Shares"), which Shares
will
represent * * * % of the issued and outstanding shares of
capital
stock of ANDARA as of the Effective Date. The issuance of such
Shares
to IURTC shall be made in accordance with the terms and conditions
of
an equity subscription agreement having commercially reasonable
terms
and conditions, the drafting of which shall be the responsibility
of
ANDARA. The equity subscription agreement will be executed by
IURTC
within sixty (60) days of the Effective Date of this Agreement.
6
REPORTS
6.1
ANDARA shall deliver
to IURTC, no later than July 31 of each calendar
year following the calendar year in which the First Commercial
Sale
occurs, a written report, including at least the following:
6.1.1 The number of Licensed Products sold and the gross revenue
from
such sales.
All such reports shall be considered the Confidential Information
of
ANDARA.
7
CONFIDENTIALITY
7.1
All Patent Rights,
including patent applications therein, and
Technical Information designated by IURTC in any reasonable manner
as
confidential within a reasonable time after it is delivered to
ANDARA,
as well as Articles 3 and 5 of this Agreement, are IURTC's
Confidential Information.
7.2
ANDARA will maintain
in secrecy and not disclose to any third party
any of IURTC's Confidential Information. ANDARA will ensure that
its
employees have access to IURTC's Confidential Information only on
a
need-to-know basis and are obligated by written agreement to
keep
ANDARA's confidentiality obligations under this Agreement.
7.3
The obligations of
confidentiality specified in Articles 7.1 and 7.2
will not extend to IURTC's Confidential Information that:
7.3.1 Becomes part of the public domain through no fault of
ANDARA;
7.3.2 Was known to ANDARA before disclosure to ANDARA by IURTC
as
established by clear and convincing documentary evidence;
7.3.3 Comprises identical subject matter to that which had been
originally
and independently developed by ANDARA personnel
without knowledge or use of any IURTC Confidential Information;
or
7.3.4 Was disclosed to ANDARA by a third party having a r
