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 000 Xxxx 00xx Xxxxxx,
Xxxxxxxxxxxx, Xxxxxxx 00000 (hereinafter "IURTC"), and Andara Life Science,
Inc., a corporation organized under the laws of the State of Indiana, having its
address at 0000 Xxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxxxxxxxx, XX 00000 (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
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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
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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.
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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 right to make
the disclosure.
*** 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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7.4 Notwithstanding the other terms of this Article 7, ANDARA may, to the
extent necessary, use IURTC's Confidential Information to secure
governmental approval to clinically test or market a Licensed Product,
to comply with a court order or governmental rule or regulation, or to
show to a potential sublicensee or contractor subject to an
appropriate confidentiality agreement. ANDARA will, in any such use,
take all reasonably available steps to maintain confidentiality of the
disclosed Information and to guard against any further disclosure.
7.5 Any and all Confidential Information belonging to ANDARA that IURTC
may receive in the course of performance of this Agreement or during
the term of this Agreement or thereafter, including without limitation
Confidential Information received from affiliates, contractors,
employees, consultants or other agents of ANDARA, shall be treated by
IURTC as strictly confidential. Unless IURTC receives the prior
written consent of ANDARA, IURTC shall not, directly or indirectly,
use any Confidential Information belonging to ANDARA for any purpose
except pursuant to the provisions of this Agreement. IURTC shall not
disclose any Confidential Information belonging to ANDARA to any third
party without the prior written consent of ANDARA.
7.6 Notwithstanding anything to the contrary herein, either Party may
disclose the Confidential Information of the other Party pursuant to
the requirement(s) of a statute, regulation, executive order, or the
order of a court or government agency, provided that before disclosing
any Confidential Information of the other Party under this Article
7.6, a Party shall, unless it may not lawfully do so, promptly notify
the other Party and allow the other Party reasonable time to oppose
such a disclosure.
8 REPRESENTATIONS AND WARRANTIES
8.1 IURTC represents and warrants that:
8.1.1 It is a corporation organized, existing, and in good standing
under the laws of Indiana.
8.1.2 It has the authority to enter into this Agreement and that the
person signing on its behalf has the authority to do so.
8.1.3 To the best of its knowledge, it is the owner (subject to any
rights retained by the U.S. government by operation of law) of
the Intellectual Property licensed in this Agreement and that it
has the authority to grant the licenses set forth herein.
8.1.4 To the best of its knowledge, as of the Effective Date of the
Agreement, there are no actions, suits or claims pending against
IURTC challenging IURTC's ownership or control of the
Intellectual Property licensed in this Agreement.
8.1.5 To the best of its knowledge, all inventors named in patent
applications within the Patent Rights have, unless indicated
otherwise to the contrary, have an obligation to assign to IURTC
their right, title and interest in and to the patent
application(s) describing and claiming their invention(s) or have
already made such an assignment.
*** 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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8.2 ANDARA represents and warrants that:
8.2.1 It is a corporation duly organized, existing, and in good
standing under the laws of Indiana.
8.2.2 The execution, delivery and performance of this Agreement have
been authorized by all necessary corporate action on the part of
ANDARA and that the person signing the Agreement on behalf of
ANDARA has the authority to do so.
8.2.3 The making or performance of this Agreement would not violate
any separate agreement it has with a third party.
8.2.4 It is not a party to any agreement or arrangement that would
prevent it from performing its duties and fulfilling its
obligations to IURTC under this Agreement.
8.2.5 It has, or will obtain at the time specified in Article 12, the
insurance coverage called for in Article 12.
8.2.6 It will exercise commercially reasonable efforts to obtain any
additional licenses from any third party needed to perform and
fulfill its duties and obligations under this Agreement,
including, but not limited to, the Development Plan.
8.2.7 There is no pending litigation and no threatened claims against
it that could impair its ability or capacity to perform and
fulfill its duties and obligations under this Agreement,
including, but not limited to, the Development Plan.
8.3 Nothing in this Agreement shall be construed as:
8.3.1 A warranty or representation by IURTC or IU as to the validity,
scope, or efficacy of Patent Rights or Technical Information.
8.3.2 A grant, by implication, estoppel, or otherwise, of any licenses
or rights under patents or other intellectual property rights of
IURTC or other persons, other than the rights expressly granted
above to Intellectual Property.
8.3.3 A grant of rights to either Party to use the name of the other
in advertising, publicity, or otherwise, except as expressly
authorized herein, without the written permission of the other
Party.
8.3.4 A grant of rights to ANDARA to use the name of IU in advertising
publicity, or otherwise without the written permission of IU.
8.4 IURTC PROVIDES THE INTELLECTUAL PROPERTY "AS IS" AND MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED WITH RESPECT TO THE INTELLECTUAL PROPERTY. THERE ARE NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS OF THE
INTELLECTUAL PROPERTY OR LICENSED PRODUCTS DERIVED FROM OR INCLUDING
IT FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE INTELLECTUAL
PROPERTY OR ANY LICENSED PRODUCT WILL NOT INFRINGE ANY
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unredacted version of this exhibit has been filed separately with the
Commission.
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PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS, OR ANY OTHER EXPRESS OR
IMPLIED WARRANTIES. IURTC MAKES NO REPRESENTATION OR WARRANTY WITH
RESPECT TO THE PERFORMANCE OF THE INTELLECTUAL PROPERTY OR ANY
LICENSED PRODUCT, INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL
VIABILITY. IURTC WILL NOT BE LIABLE TO ANDARA, OR ITS SUCCESSORS,
ASSIGNS, CONTRACTORS, OR SUBLICENSEES, OR ANY THIRD PARTY REGARDING
ANY CLAIM ARISING FROM OR RELATING TO ANDARA'S USE OF THE INTELLECTUAL
PROPERTY, ANY LICENSED PRODUCT, OR FROM THE MANUFACTURE, USE,
IMPORTATION OR SALE OF LICENSED PRODUCTS, OR FOR ANY CLAIM FOR LOSS OF
PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL,
EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND.
8.5 OTHER THAN THE WARRANTIES EXPRESSLY STATED IN THIS AGREEMENT, ANDARA
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED. ANDARA WILL NOT BE LIABLE TO IURTC FOR ANY CLAIM
FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR
INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL, DAMAGES OF
ANY KIND EVEN IF ANDARA IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES
OR SUCH DAMAGES ARE FORESEEABLE.
9 APPLICATION, PROSECUTION, AND MAINTENANCE OF PATENT RIGHTS
9.1 ANDARA shall assist IURTC in the preparation, filing, prosecution,
issue and maintenance of Patent Rights patents and applications. IURTC
and ANDARA shall both be copied on all communications regarding the
Patent Rights and applications which include, but are not limited to
copies of all applications, Patent Office Actions and Responses, and
all other Patent Office communications.
9.2 ANDARA will reimburse IURTC for expenses incurred for preparing,
filing, and prosecuting patents and patent applications in the Patent
Rights prior to the Effective Date within one hundred eighty (180)
days after receiving documentation of such. To the best of IURTC's
knowledge, no such expenses have been incurred as of the Effective
Date. Subsequent to the Effective Date, IURTC shall provide reasonable
advance notice to ANDARA of any activity that will incur expenses for
which reimbursement by ANDARA is required under this Agreement, so
that ANDARA may prevent such expenses from being incurred.
9.3 During the Term of the Agreement, ANDARA will reimburse IURTC for all
reasonable and documented costs and expenses incurred by IURTC in the
preparation, filing, prosecution, issue and maintenance of patents and
applications within the Patent Rights within thirty (30) days of
receipt from IURTC of copies of correctly rendered billing invoices
for such costs and expenses. An invoice is "correctly rendered" if:
(i) the amount for which reimbursement is sought is correctly
calculated; (ii) the invoice is set out in a manner that enables
ANDARA to ascertain the expenses to which the invoice
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relates and the amount payable in respect of each expense item; and
(iii) the invoice is accompanied (where reasonably requested by
ANDARA) by documentation substantiating all expenses for which
reimbursement is sought. All reimbursements under this Article 9.3 are
subject to ANDARA receiving a correctly rendered invoice from IURTC.
9.4 If ANDARA elects not to reimburse IURTC for any documented fees or
expenditures relating to any Patent Rights, ANDARA shall give IURTC
written notice of such election at least ninety (90) days in advance
of the date on which such expenditure is to be made or such fee is due
to be paid. Upon IURTC's receipt of such notice, the license to those
patent applications or patents in the Patent Rights granted to ANDARA
under Articles 3.1 and 3.2 for which IURTC has not been reimbursed
shall terminate, and IURTC shall be free, at IURTC's sole discretion
and without any further obligation to ANDARA, to continue prosecution
or maintenance, for IURTC's sole use and benefit or to abandon the
patent applications.
10 INFRINGEMENT, ENFORCEMENT, AND DEFENSE
10.1 The Parties shall give prompt written notice to each other of (a) any
known or suspected infringement of the Patent Rights or unauthorized
use of the Technical Information by a third party, and (b) any claim
that a Licensed Product infringes the intellectual property rights of
a third party.
10.2 ANDARA at its sole expense will attempt to xxxxx any infringement of
the Patent Rights or unauthorized use of Technical Information by a
third party. Upon receipt of IURTC's written consent, such consent not
to be unreasonably withheld, ANDARA may initiate and prosecute actions
in IURTC's name against third parties for infringement of the Patent
Rights through outside counsel of its choice who are reasonably
acceptable to IURTC. ANDARA shall consult with IURTC prior to and in
conjunction with all significant issues, shall keep IURTC informed of
all proceedings, and shall provide copies to IURTC of all pleadings,
legal analyses, and other papers related to such actions. IURTC will
provide reasonable assistance to ANDARA in prosecuting any such
actions.
10.3 ANDARA at its sole expense shall defend third party claims for (a)
patent or intellectual property infringement and injury, and (b)
death, bodily injury, property damage, damage to business, or product
liability brought against ANDARA and/or IURTC arising from or relating
to Intellectual Property or a Licensed Product. ANDARA will have the
right to conduct the defense of such actions through outside counsel
of its choice who are reasonably acceptable to IURTC. ANDARA shall
consult with IURTC prior to and in conjunction with all significant
issues, shall keep IURTC informed of all proceedings, and shall
provide copies to IURTC of all pleadings, legal analyses, and other
papers related to such actions. IURTC will provide reasonable
assistance to ANDARA in defending any such actions.
10.4 Notwithstanding anything herein to the contrary and absent IURTC's
prior written consent, ANDARA shall not settle or compromise any claim
or action in a manner that
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imposes restrictions or obligations on IURTC, requires any financial
payment by IURTC, or grants rights or concessions to a third party to
Intellectual Property or a Licensed Product.
10.5 If ANDARA fails or declines to take any action under Article 10.2
within a reasonable time after learning of third party infringement of
the Patent Rights, IURTC shall have the right, but not the obligation,
to take appropriate actions against any such third party. If ANDARA
fails to timely defend a claim or action under Article 10.3, IURTC may
assume the defense for the account of and at the risk of ANDARA and
any resulting liability will be deemed conclusively to be a liability
of ANDARA.
11 INDEMNIFICATION
11.1 ANDARA shall indemnify, defend, and hold harmless IURTC, its Board of
Directors, and employees, and IURTC's successors, assigns, and agents
(collectively, "IURTC Indemnitees") from and against any and all
judgments, liabilities, losses, damages, actions, claims, or expenses
(including all attorney's fees and costs incurred by IURTC
Indemnitees) arising out of, relating to, or incidental to (a) the use
of any Intellectual Property in the design, development, production,
manufacture, sale or offer for sale, use, importation, lease,
marketing or promotion of any Licensed Product by ANDARA or its
contractors, employees, Sublicensees, assigns, or agents, (b) injury
or death to any person, damage to property, or any injury to business,
including, but not limited to, business interruption or damage to
reputation, arising out of, relating to, or incidental to the use of
Intellectual Property by ANDARA or the use of a Licensed Product, and
(c) any third party claim that any use or licensing of Intellectual
Property by ANDARA or development of Licensed Products by ANDARA
violates or infringes a third party's intellectual property rights.
11.2 ANDARA's indemnification obligations shall not apply to any liability,
damage, loss or expense to the extent that it is attributable to: (a)
the willful misconduct of the IURTC Indemnitees; or (b) any breach of
IURTC's warranties or obligations under this Agreement.
12 INSURANCE
12.1 ANDARA will at all times comply, through insurance or self-insurance,
with all statutory workers' compensation and employers' liability
requirements covering all employees with respect to activities
undertaken in performance of this Agreement. This requirement may be
met by insurance or self-insurance coverage provided to ANDARA by a
Sublicensee.
12.2 In addition to the foregoing, on the first date of the commercial
distribution of any Licensed Product or on the date of initiation of
any human trials whichever occurs sooner, ANDARA and any Sublicensees
as appropriate, will obtain and maintain Broad Form Comprehensive
General Liability ("BFCGL") insurance with a reputable and financially
secure insurance carrier(s). The BFCGL insurance will include, among
all
*** 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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other coverages standing in such BFCGL policies, coverage for product
liability and contractual liability.
12.3 The BFCGL insurance policy shall identify IURTC as an additional
insured and shall provide to ANDARA, its affiliates, and/or each
Sublicensee, minimum annual limits in the following amounts:
12.3.1 * * * per occurrence and * * * in the aggregate.
12.4 Insurance policies purchased to comply with this Article shall be kept
in force for ten (10) years after the last sale the last Licensed
Product is sold.
12.5 ANDARA or any Sublicensee as appropriate, will provide IURTC with a
certificate of insurance and notices of subsequent renewals. The
certificates and policies must provide that ANDARA's carrier will
notify IURTC in writing at least thirty (30) days prior to
cancellation or material change in coverage.
12.6 The specified minimum coverages do not constitute a limitation on
ANDARA's obligation to indemnify IURTC under this Agreement.
13 TERMINATION
13.1 ANDARA may terminate this Agreement with or without cause on ninety
(90) days advance written notice to IURTC. The license rights granted
in Article 3 shall terminate at the end of the 90-day period.
13.2 IURTC may terminate this Agreement as provided in Article 4.5 for
ANDARA's failure to meet the diligence requirements of Article 4.
13.3 A Party may terminate this Agreement on sixty (60) days advance
written notice to the other Party upon the other Party's material
breach of the Agreement. The termination becomes effective at the end
of the 60-day period unless the breaching Party has fully cured the
material breach within that time, provided that if the material breach
is incapable of cure within the 60-day period, the breaching Party
shall have such longer period as is reasonably necessary if the
breaching Party commences a cure for the material breach within the
60-day period and diligently pursues the cure until completion. A
material breach includes, but is not limited to, one or more of the
following:
13.3.1 Breach or falsity of any of a Party's representations or
warranties made in this Agreement.
13.3.2 Failure by ANDARA to obtain and/or maintain levels of insurance
as required in Article 12.
13.3.3 Failure by ANDARA to indemnify in accordance with Article 11 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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13.3.4 Failure by ANDARA properly to engage or consult IURTC in suits
or claims to xxxxx or defend as required in Article 10 of this
Agreement, where such failure results in liability to IURTC.
13.4 If ANDARA enters bankruptcy or receivership, voluntarily or
involuntarily, all obligations of IURTC and all rights (but not
obligations) of ANDARA terminate immediately without the need for
either IURTC or ANDARA to take any action.
13.5 Upon the date of termination of this Agreement for any reason, ANDARA
shall return, and shall cause all Sublicensees, if sublicensing
agreements are also terminated, to return to IURTC all Confidential
Information of IURTC (as defined in Article 7) received during the
Term of this Agreement.
13.6 As of the date of termination of this Agreement by either Party for
any reason pursuant to the terms herein, all license rights granted to
ANDARA under Article 3 shall terminate. ANDARA's obligations to pay
fees or other payments and patent expenses (Article 10) accruing prior
to termination shall survive termination. Provided all monetary
obligations of ANDARA to IURTC arising under this Agreement have been
satisfied, ANDARA and Sublicensees may continue to sell in the
ordinary course of business for a period of three (3) months following
the effective date of termination all quantities of Licensed Products
which are fully manufactured and in ANDARA's and/or Sublicensees'
normal inventory at the date of termination.
14 USE OF NAMES: Neither Party may use the name of the other for any
commercial, advertisement, or promotional purpose without the prior written
consent of the other. ANDARA may not use the name of IU for any commercial,
advertisement, or promotional purpose without the prior written consent of
IU.
15 ASSIGNMENT OR PLEDGE OF THE AGREEMENT: This Agreement, in whole or in part,
shall not be assigned by either Party to any third party without the
written consent of the non-assigning Party. However, ANDARA may assign the
entire Agreement, without IURTC's consent, to a third party that acquires
substantially all of ANDARA's business or assets to which this Agreement
relates through merger, sale, acquisition, or other similar transaction,
provided that the successor agrees in writing (with a copy of such assent
to IURTC within ten (10) days of the effective date of the transaction) to
assume all obligations and liabilities of ANDARA to IURTC. The rights
granted in this Agreement may not be pledged or hypothecated in any way by
ANDARA or any Sublicensee to secure any purchase, lease, or loan.
16 NOTICE: Any required or permissive notice under this Agreement will be
sufficient if in writing and delivered personally, by recognized national
overnight courier, or by registered or certified mail, postage prepaid and
return receipt requested, to the address below and will be deemed to have
been given as of the date shown on the receipt if by certified or
registered mail, or the day following dispatch if by overnight courier.
If to IURTC:
*** 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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Vice President of Technology Transfer
Attn: IURTC Tech # 05124
Indiana University Research and Technology Corporation
000 X. 00xx Xxxxxx
Xxxxxxxxxxxx, XX 00000
If to ANDARA:
Xxxx Xxxxxx, CEO
Andara Life Science, Inc.
Xxxxx 000
0000 Xxxxxx Xxxxxxxxx
Xxxxxxxxxxxx, XX 00000
17 GENERAL PROVISIONS
17.1 This Agreement shall be governed by and interpreted according to the
laws of the State of Indiana, to the exclusion of any conflict of law
or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive
law of another jurisdiction.
17.2 No waiver of any breach of this Agreement shall constitute a waiver of
any other breach of the same or any other provision of this Agreement,
and no waiver shall be effective unless made in writing by the Party
against whom the waiver is sought to be asserted.
17.3 The Parties acknowledge that they have read this Agreement, including
any Exhibits attached hereto, in its entirety and agree that this
instrument comprises the entire agreement, contract, and understanding
of the Parties relating to the subject matter of the Agreement.
17.4 This Agreement cannot be changed, modified or amended except by a
written instrument subscribed by authorized representatives of the
respective Parties.
17.5 Neither Party is an agent or contractor of the other as a result of
any transaction under or related to this Agreement. Neither Party may
in any way pledge the other Party's credit or incur any obligation on
behalf of the other Party.
17.6 Neither Party shall be liable to the other Party for any special,
consequential, incidental, exemplary, punitive, or indirect damages
arising out of or relating to this Agreement, however caused, under
any theory of liability.
17.7 The provisions of this Agreement are severable in that if any
provision in the Agreement is finally determined by a court of
competent jurisdiction to be invalid or unenforceable, the remaining
provisions of the Agreement shall remain in full force and effect.
*** 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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17.8 If the performance of any obligation under this Agreement is prevented
or impaired by acts of war, riot, acts or defaults of common carriers,
or governmental laws or regulations, a Party will be excused from
performance so long as such cause continues to prevent or impair that
Party's performance. The Party claiming such force majeure excuse must
promptly notify the other Party of the existence of the cause and must
at all times use diligent efforts to resume and complete performance.
17.9 IURTC has no responsibility and assumes no liability for product
design, development, pre- or post-market regulatory approval,
servicing, distribution, or marketing of any Licensed Product, or for
any decisions made or strategies devised relating to any Licensed
Product.
17.10 ANDARA agrees, and shall cause all Sublicensees to agree, that in the
event an IU faculty or staff member serves ANDARA or any Sublicensee
in the capacity of consultant, officer, employee, board member,
advisor, or other designation, pursuant to contract or otherwise, such
IU faculty or staff member shall serve in his or her individual
capacity, as an independent contractor, and not as an agent or
representative of IURTC or IU, that IURTC or IU exercises no authority
or control over such faculty or staff member while acting in such
capacity, that IURTC or IU receives no benefit from such activity, and
that IURTC or IU assume no liability or obligation in connection with
any such work or service undertaken by such faculty or staff member.
ANDARA further agrees, and shall cause all Sublicensees to agree, that
any breach, error, or omission by an IU faculty or staff member acting
in the capacity set forth above in this paragraph shall not be imputed
or otherwise attributed to IURTC or IU, and shall not constitute a
breach of this Agreement by IURTC.
17.11 All representations, warranties, covenants, and agreements made
herein that, by their express terms or by implication, are to be
performed after the execution or termination of this Agreement, or are
prospective in nature, shall survive such execution and/or
termination, as the case may be. This shall include, but not be
limited to, the provisions in Articles 7, 8, 11, 12, 13.5 and 14.
17.12 Each Party shall, at the reasonable request of the other, execute and
deliver to the other such instruments and/or documents and shall take
such actions as may be required to more effectively carry out the
terms of this Agreement.
17.13 This Agreement may be executed in counterparts, each of which shall
be deemed an original and all of which when taken together shall be
deemed one instrument.
WITNESS: The Parties have caused this Agreement to be executed in duplicate by
their duly qualified representatives.
IURTC ANDARA
/s/ Xxxx X. Xxxxxx /s/ Xxxx X. Xxxxxx
-------------------------------------- ---------------------------------------
SIGNATURE SIGNATURE
Xxxx X. Xxxxxx Xxxx X. Xxxxxx
-------------------------------------- ---------------------------------------
NAME NAME
*** 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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Vice President of Technology Trans. President & CEO
-------------------------------------- ---------------------------------------
TITLE TITLE
7/29/2005 7/29/2005
-------------------------------------- ---------------------------------------
DATE DATE
*** 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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EXHIBIT A
1. * * *.
2. * * *.
*** 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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EXHIBIT B
*** 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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