Exhibit
10.38
Portions herein
identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 406 of the Securities Act of
1933, as amended. A complete copy of this document has been filed
separately with the Securities and Exchange Commission.
RESEARCH AND LICENSE
AGREEMENT
This Agreement is entered into as of October 10,
2006 (“Effective Date”), by and between Albert Einstein
College of Medicine of Yeshiva University, a Division of Yeshiva
University, a corporation organized and existing under the laws of
the State of New York, having an office and place of business at
1300 Morris Park Avenue, Bronx, New York 10461
(“AECOM”) and Hana Biosciences, Inc., a corporation
organized and existing under the laws of the State of Delaware,
having an office and place of business at 7000 Shoreline Court,
Suite 370, South San Francisco, CA 94080
(“Licensee”).
Statement
AECOM has established a laboratory directed by
Dr. Roman Perez-Soler (“the Investigator”) to conduct
research relating, in part, to the use of Vitamin K for prevention
and treatment of skin rash secondary to anti-EGFR therapy. Licensee
wishes to provide financial support for a research project to be
conducted by AECOM in the Investigator’s laboratory and
wishes to acquire an exclusive license in the Field (as defined
below) from AECOM with respect to certain patent rights resulting
from such research and certain other patent rights of AECOM, as
described herein.
NOW, THEREFORE, in consideration of the promises
and mutual covenants, conditions and limitations herein contained
and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, AECOM and Licensee
agree as follows:
1.
Definitions
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1.01
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“Field” means any and all uses of the Agreement
Patents.
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1.02
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“Agreement Patents”
means (1) the provisional and
international patent applications listed on Appendix A, together
with any and all patents which issue from or are based on such
patent applications and from any and all divisionals,
continuations, continuations-in-part and foreign counterparts of
such patent applications, and any and all reissues, renewals and
extensions or the like of such patents and any and all U.S. and
foreign patents which are based on such patents and patent
applications; and (2) any and all Future Inventions. Appendix A
shall be updated from time-to-time by the parties.
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1.03
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“Future Inventions”
means future patents and patent
applications owned by AECOM which (a) name the Investigator as an
inventor, and (b) result from the Research Project and (c) relate
to prevention and treatment of skin rash secondary to anti-EGFR
therapy.
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1.04
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“Licensed Product”
means any product or service in the
Field, the development, manufacture, use, provision or sale of
which is covered by a claim in an Agreement Patent.
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1.05
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“Net Sales”
means the total consideration, in
any form, received by Licensee, Affiliates and Sublicensees as
consideration for the sale, lease, provision or other disposition
of Licensed Products by Licensee and/or Affiliates and/or
Sublicensees to an independent third party, less:
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(a)
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customary and
reasonable trade discounts actually allowed, refunds, returns and
recalls; and,
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(b)
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when included
in gross sales, customary and reasonable freight, shipping, duties,
and sales, V.A.T. and/or use taxes based on sales prices, but not
including taxes when assessed on incomes derived from such
sales.
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If Licensee
and/or Affiliates and/or Sublicensees accepts from independent
third parties any non-cash consideration as Net Sales or provides
Licensed Products at no charge or at a reduced charge (e.g. in
connection with the sale of anti-EGFR therapies), Licensee shall
provide written notice of same to AECOM. For any non-cash
consideration received as Net Sales or any provision of Licensed
Products at no charge or at a reduced charge, the parties will
determine the present day value of such consideration or reduction
and that value shall be added to Net Sales in place of the non-cash
consideration or reduction. If the parties are unable to agree on
such value, then the parties shall appoint and share the cost of an
independent third party to make such determination, which
determination shall be binding on the parties.
In the event
that, during a particular calendar quarter, a Licensed Product is
sold in combination with one or more other products, whether or not
such other products are packaged or otherwise physically combined
with such Licensed Product, for a single price (a
“Combination Product”), Net Sales from sales of a
Combination Product, for purposes of calculating royalties due
under this Agreement, shall be calculated by multiplying the Net
Sales of the Combination Product by the fraction A/(A+B), where A
is the average per unit sales price for such calendar quarter of
the Licensed Product sold separately in the country of sale and B
is the average per unit sales price for such calendar quarter of
the other product(s) sold separately in the country of sale. In the
event that no separate sales are made of the Licensed Product
and/or the other product(s) in the country of sale, separate sale
prices in commensurate countries may be used instead. In the event
that no separate sales are made of the Licensed Product and/or the
other product(s), Net Sales from sales of a Combination Product,
for purposes of determining royalty payments on such Combination
Products, shall be calculated using a method to be agreed to by the
parties. If the parties are unable to agree on a method or on the
resulting calculation, then the parties shall appoint and share the
expense of an independent third party to make such calculation,
which calculation shall be binding on the parties.
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1.06
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“Net Proceeds”
shall mean the total consideration,
in any form (including, but not limited to, license signing fees,
maintenance fees, milestone and minimum payments, whether or not
such fees and payments are creditable against future royalties to
be paid to Licensee, research and development funds other than
Contract Research, and just that portion of the funds received for
equity purchases of Licensee which exceeds the fair market value of
the equity), but excluding royalties based on Net Sales of
Sublicensees, that is received by Licensee from a Sublicensee in
connection with the grant to said Sublicensee of rights under the
Agreement Patents. For any non-cash consideration received as Net
Proceeds, the parties will determine the present day value of such
consideration and that value shall be added to Net Proceeds in
place of the non-cash consideration. If the parties are unable to
agree on such value, then the parties shall appoint and share the
cost of an independent third party to determine the present day
value of such consideration, which determination shall be binding,
and that value shall be added to Net Proceeds in place of the
non-cash consideration. Notwithstanding anything to the contrary
contained herein, Net Proceeds does not include (i) Contract
Research and (ii) loans to Licensee and its Affiliates by a
Sublicensee relating to the Agreement Patents, except to the extent
the interest charged for such loan is less than the fair market
value (in which case only such difference between the payment due
at fair market value and the payment made by Licensee shall
constitute Net Proceeds) or to the extent that the principal of a
loan is forgiven (in which case only such forgiven amount shall
constitute Net Proceeds).
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1.07
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“Affiliate”
means any entity, that, directly or
indirectly, through one or more intermediates, controls, is
controlled by, or is under common control with Licensee. For the
purposes of this definition, control shall mean the direct or
indirect ownership of at least fifty percent (50%) of (i) the stock
shares entitled to vote for the election of directors or (ii)
ownership interest.
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1.08
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“Sublicensee”
shall mean any non-Affiliate third
party to whom Licensee has granted the right to make and sell (or
otherwise dispose of) Licensed Products.
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1.09
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“Contract Research”
shall mean those funds received by
Licensee from a Sublicensee in connection with the grant to said
Sublicensee of rights under Agreement Patents, which funds are
actually used to pay for research and/or development by Licensee
relating directly to Licensed Products, which work is to be
performed by or for Licensee after the date of the sublicense
agreement and with results to be reported to and licensed to
Sublicensee and which is to be performed at a total cost that does
not exceed Licensee’s direct costs. Notwithstanding the
foregoing, Contract Research funds received from a Sublicensee
which are in excess of [***] percent ([***]%) of the total
consideration received by Licensee from that Sublicensee in any
calendar year shall be excluded from the definition of Contract
Research and included in the definition of Net Proceeds, unless
otherwise approved at the time of execution of the relevant
sublicense by AECOM.
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1.10
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“Confidential
Information” means any information designated as such in
writing by the disclosing party, whether by letter or by the use of
an appropriate proprietary stamp or legend, prior to or at the time
any such confidential or proprietary materials or information are
disclosed by the disclosing party to the recipient. Notwithstanding
the foregoing, information or materials which are orally or
visually disclosed to the recipient by the disclosing party, or are
disclosed in a writing or other tangible form without an
appropriate letter, proprietary stamp or legend, shall constitute
Confidential Information if the disclosing party, within thirty
(30) days after such disclosure, delivers to the recipient a
written document or documents describing such information or
materials and referencing the place and date of such oral, visual,
written or other tangible disclosure.
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1.11
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“Research Project”
means research work as defined in
Appendix B as well as in amendments and modifications of Appendix B
which are mutually agreed upon in writing by AECOM and Licensee,
the purpose of which is to support the filing on an investigational
new drug application (“IND”) with the U.S. Food and
Drug Administration and the commercial development of the Licensed
Product(s).
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2.
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AECOM’s Agreements With U.S.
Government
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2.01
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AECOM, through
its Investigator, has and will perform research sponsored in part
by the United States Government and related to the prevention and
treatment of skin rash secondary to anti-EGFR therapy. As a result
of this government sponsorship of the aforementioned research, the
United States Government retains certain rights in such research as
set forth in 35 U.S.C. §200 et. seq. and applicable
regulations.
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2.02
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The continuance
of such government sponsored research by AECOM and its Investigator
during the term of this Agreement will not constitute a breach of
this Agreement. All rights reserved to the U.S. Government under 35
U.S.C. §200 et. seq. and applicable regulations shall remain
so reserved and shall in no way be affected by this Agreement.
AECOM and its Investigator are not obligated under this Agreement
to take any action which would conflict in any respect with their
past, current or future obligations to the U.S. Government as to
work already performed and to be performed in the
future.
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3.01
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Within thirty
(30) days of the Effective Date Licensee will reimburse AECOM for
all expenses (not to exceed US$[***]) incurred prior to the
Effective Date in connection with the preparation, filing,
prosecution and maintenance of the Agreement Patents. Amounts paid
by Licensee pursuant to this paragraph are non-refundable and not
creditable against any other payment due to AECOM.
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3.02
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As of and after
the Effective Date, Licensee will pay the cost of preparing,
filing, prosecuting, maintaining and resisting challenges to the
validity of the Agreement Patents (as well as the cost of
preparing, filing, prosecuting, maintaining and resisting
challenges to the validity of corresponding applications in at
least the United States, Europe (an EPO filing designating all
member countries), Canada, Japan, and Australia) using patent
counsel selected by Licensee and approved by AECOM, which approval
shall not be unreasonably withheld (“Patent Counsel”).
In this regard, Licensee will pay the cost of defending and/or
prosecuting any interference, reexamination, reissue, opposition,
cancellation and nullity proceedings involving Agreement Patents.
Licensee shall provide direction to Patent Counsel regarding the
preparation, filing, prosecution, maintenance and defense of the
Agreement Patents and Patent Counsel shall keep AECOM informed
concerning such patents and applications. The parties agree to
consult with each other concerning the preparation, filing,
prosecution, maintenance and challenges to the validity of such
patents and applications. Each party shall cooperate with any
reasonable request of the other in connection with any such
preparation, filing, prosecution, maintenance and/or defense. In
the event that Licensee elects not to maintain, defend or prosecute
any patent or patent application within the Agreement Patents,
Licensee shall give AECOM thirty (30) days prior written notice of
such election. Any patents or patent applications so elected shall
at the end of the notice period cease to be considered Agreement
Patents, and AECOM shall then be free, at its election, to abandon
or maintain the prosecution of such patent application or issued
patent or grant rights to such patent application or issued patent
to third parties.
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3.03
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AECOM will
promptly disclose to the Licensee any potential Future Inventions.
Within thirty (30) business days of Licensee’s receipt of a
disclosure of a Future Invention, Licensee shall determine whether
it desires that a patent application should be prepared and filed
on such Future Invention and shall provide written notification to
that effect to AECOM. Following a determination by Licensee that it
desires that a patent application be prepared and filed, Licensee
will direct Patent Counsel to prepare and file a patent application
in consultation with AECOM, which application will be filed within
thirty (30) business days of such determination. Licensee will pay
the cost of preparing, filing, prosecuting and maintaining and
resisting challenges to the validity of such patent applications
and patents. Licensee shall provide direction to Patent Counsel
regarding the preparation, filing, prosecution, maintenance and
defense of such patent applications and patents and Patent Counsel
shall keep AECOM informed concerning such applications and patents.
The parties agree to consult with each other concerning the
preparation, filing, prosecution, maintenance and challenges to the
validity of such applications and patents. Each party shall
cooperate with any reasonable request of the other in connection
with any such preparation, filing, prosecution, maintenance and/or
defense. Such applications and patents will be included in the
definition of Agreement Patents and added to Appendix A. In the
event that Licensee determines not to file a patent application on
any Future Invention or otherwise fails to provide written
notification within the timeframe indicated above, (i) the
definition of Agreement Patents will not be amended to include any
patent application filed on such Future Invention, and (ii) AECOM
shall be free to exploit such Future Invention with no further
obligation to Licensee.
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3.04
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Amounts paid by
Licensee pursuant to Sections 3.02 and 3.03 will be non-refundable
and not creditable against any other payment due to
AECOM.
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4.01
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AECOM, through
the Investigator, will conduct the two year Research Project and
AECOM will be solely responsible for the governance of the Research
Project.
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4.02
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AECOM and
Licensee shall inform each other of any developments that might
affect the Research Project, and shall supply or provide to each
other for the duration of the Research Project any and all relevant
materials, documentation or information that might be required for
the best performance of the Research Project. The coordination of
decisions and the exchange of information between the two companies
shall be undertaken by Investigator (for AECOM) and initially by
Mark J. Ahn (for Licensee).
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4.03
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AECOM shall
keep Licensee informed of the progress and results of the Research
Project by submitting a written summary report to Licensee every
six (6) months following the Effective Date.
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4.04
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AECOM shall
promptly inform Licensee of any invention, discovery, technology,
device, process or formulation resulting from the Research Project,
whether or not patentable, but excluding a Future Invention (a
“Research Project Invention”). Licensee shall then have
an exclusive six month period from the date of AECOM’s notice
to Licensee in which to negotiate a license from AECOM of its
rights relating to such Research Project Invention. The parties
shall negotiate the terms of such license in good faith.
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5.01
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In
consideration of the performance of the Research Project by AECOM,
Licensee will pay AECOM the sum of [***] Dollars (US$[***]). This
sum shall be deemed to include any applicable tax and overhead and
shall be paid in two installments as set out in the following
paragraph.
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5.02
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Licensee will
pay AECOM [***] Dollars (US$[***]) within thirty (30) days of the
Effective Date, and [***] (US$[***]) within [***] ([***]) months of
the Effective Date.
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5.03
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AECOM will not
incur any expense in excess of the amounts budgeted without first
obtaining written authorization from Licensee.
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5.04
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If the
Investigator should discontinue working for AECOM, AECOM has the
right to name an alternative. If the alternative is not reasonably
acceptable to Licensee, Licensee has the right to terminate the
research part of the present Agreement without affecting the
license part of the present Agreement, provided, however, that
Licensee shall reimburse AECOM for any uncancellable salary
expenses that AECOM has committed to pay for personnel working on
the Research Project.
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6.01
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Subject to
Article 2, AECOM hereby grants to Licensee and Affiliates a
worldwide, exclusive license, with the right by Licensee only to
grant sublicenses to unaffiliated third parties, under
AECOM’s rights in the Agreement Patents to import, make, have
made, use, provide, offer to sell, and sell Licensed Products.
Licensee will not grant or amend any sublicense under Agreement
Patents unless it first submits a full and complete draft of any
such proposed sublicense or amendment (as the case may be) to AECOM
and then receives the prior written consent of AECOM, which consent
will not be unreasonably withheld or delayed. Licensee shall
provide AECOM with a full and complete copy of any approved
sublicense or amendment within thirty (30) days of execution
thereof by Licensee, which sublicense and amendment shall be
treated as Licensee Confidential Information under Article 7. The
terms of any sublicense agreement shall not contradict the terms of
this Agreement and shall include (at least) the following
provisions: prohibiting any use of AECOM’s name (consistent
with Section 11.01), requiring indemnification of AECOM (consistent
with Section 14.04), requiring appropriate insurance (consistent
with Section 14.09), and disclaiming any warranties or
representations by AECOM (consistent with Sections 14.05 and
14.06).
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6.02
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Notwithstanding
the exclusive rights granted to Licensee pursuant to Section 6.01,
AECOM shall retain the right to make, use and practice Agreement
Patents in its own laboratories solely for non-commercial
scientific purposes and for continued non-commercial research.
Further, AECOM shall have the right to make available to
not-for-profit scientific institutions and non-commercial
researchers materials covered under Agreement Patents, solely for
non-commercial scientific and research purposes, provided this is
done under a material transfer agreement.
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6.03
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Nothing
contained in this Agreement shall be construed or interpreted as a
grant, by implication or otherwise, of any license except as
expressly specified in Section 6.01 hereof. The license granted
herein shall apply to the Licensee and Affiliates, except that
Affiliates shall not have the right to grant sublicenses. If any
Affiliate exercises rights under this Agreement, such Affiliate
shall be bound by all terms and conditions of this Agreement,
including but not limited to indemnity and insurance provisions,
which shall apply to the exercise of the rights, to the same extent
as would apply had this Agreement been directly between AECOM and
the Affiliate. In addition, Licensee shall remain fully liable to
AECOM for all acts and obligations of Affiliates such that acts of
Affiliates shall be considered the acts of Licensee.
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7.01
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Nothing herein
contained shall preclude AECOM from making required reports or
disclosures to the NIH or to any other philanthropic or
governmental funding organization, provided, however, that no
Licensee Confidential Information is disclosed in the
process.
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7.02
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Licensee will
retain in confidence Confidential Information of AECOM and Licensee
will not disclose any such Confidential Information to any third
party without the consent of AECOM, except that Licensee shall have
the right to disclose such information to any third party for
commercial or research and development purposes under written terms
of confidentiality and non-disclosure which are commercially
reasonable. Licensee will keep confidential all Confidential
Information of AECOM for a period of five (5) years after
termination or expiration of this Agreement, provided, however,
that the obligation of confidentiality will not apply to any such
information which:
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(a)
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was known to
Licensee or generally known to the public prior to its disclosure
hereunder; or
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(b)
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subsequently
becomes known to the public by some means other than a breach of
this Agreement, including but not limited to publication and/or
laying open to inspection of any patent applications or patents;
or
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(c)
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is subsequently
disclosed to Licensee by a third party having a lawful right to
make such disclosure; or
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(d)
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is required to
be disclosed by regulation, law or court order to the most limited
extent necessary to comply therewith, provided AECOM is given a
fair opportunity to defend against such disclosure; or
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(e)
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is
independently developed by Licensee as evidenced by
Licensee’s written records.
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7.03
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During the term
of this Agreement, it is contemplated that AECOM may become aware
of Confidential Information of Licensee, including without
limitation, written, oral, visual or other proprietary and
confidential business information, scientific information,
technology, computer software, inventions, technical information,
biological materials, processes and the like which are owned or
controlled by Licensee (“Licensee Confidential
Information”). AECOM agrees to retain such Licensee
Confidential Information in confidence and not to disclose any such
Licensee Confidential Information to a third party without prior
written consent of Licensee for a period ending five (5) years
after termination or expiration of this Agreement, except that such
obligations shall not apply to any information which:
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(a)
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was known to
AECOM or generally known to the public prior to its disclosure
hereunder; or
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(b)
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subsequently
becomes known to the public by some means other than a breach of
this Agreement; or
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(c)
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is subsequently
disclosed to AECOM by a third party having a lawful right to make
suc
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