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CONFIDENTIAL TREATMENT REQUESTED
Exhibit
10.6
TECHNOLOGY LICENSE AGREEMENT*
This
license agreement (“Agreement”) is by and
between:
MAYO
FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, a Minnesota
charitable corporation, located at 200 First Street SW,
Rochester, Minnesota 55905-0001 (“MAYO”);
and
NILE
PHARMACEUTICALS, INC., a Delaware corporation, incorporated by
Two River Group Holding, LLC, located at 689 Fifth Avenue,
14th Floor, New York New York 10022 (“NILE”), each
a “Party,” and collectively,
“Parties.”
WHEREAS,
MAYO desires to make its patent rights and know-how available
for the development and commercialization of products for
public use and benefit; and
WHEREAS,
MAYO is willing to grant and NILE is willing to accept an
exclusive license under certain patent rights for the purpose
of developing and commercializing such products, as set forth
below; and
WHEREAS,
NILE will be responsible for designing, developing, marketing,
sublicensing and selling any products in accordance with the
grant of rights hereunder.
NOW
THEREFORE, in consideration of the foregoing and their mutual
covenants set forth below, the Parties agree as
follows:
Article 1 - Definitions
For
purposes of this Agreement, each term defined in this Article
will have the meaning specified for it below and will be
applicable both to the singular and plural forms:
1.01 “Affiliate”
means:
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(a)
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with
respect to MAYO means any corporation or other entity within the
same “controlled group of corporations” as MAYO or its
parent Mayo Foundation. For purposes of this definition, the term
“controlled group of corporations” shall have the same
definition as Section 1563 of the Internal Revenue Code as of
November 10, 1998, but shall include corporations or other entities
that, if not a stock corporation, more than 50% of the board of
directors or other governing body of such corporation or other
entity is controlled by a corporation within the controlled group
of corporations of MAYO or Mayo Foundation. MAYO's Affiliates
include, but are not limited to: Mayo Foundation; Mayo
Collaborative Services; Inc., Rochester Methodist Hospital; Saint
Mary's Hospital; Mayo Clinic Rochester; Mayo Clinic Jacksonville,
Florida; St. Luke's Hospital, Jacksonville, Florida; Mayo Clinic
Arizona; Mayo Clinic Hospital, Arizona; Mayo Regional Practices,
P.C., Decorah, Iowa; and Mayo Health System West Central Wisconsin
and controlled or wholly-owned subsidiary corporations of all of
the above.
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*
Confidential treatment has been requested for certain portions of
this Exhibit. The confidential portions of this Exhibit have been
omitted and filed separately with the Securities and Exchange
Commission. Such portions have been marked with “***”
at the exact place where material has been
omitted.
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(b)
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with
respect to NILE means any corporation or other person controlling,
controlled by or under common control with NILE.
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(c)
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The
term “control” means the possession, directly or
indirectly, of the power to direct the management and policies of a
corporation or person, whether through the ownership of voting
securities, by contract or otherwise. Control shall be deemed to
exist in the case of the ownership, directly or indirectly, of 50%
or more of the equity interests in any such
corporation.
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1.02
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“Change of Control” shall
mean a merger, consolidation, acquisition or the transfer of all,
or substantially all, of the business interests of NILE to which
this Agreement relates to which NILE is a party where the
shareholders of NILE immediately prior to effective date of such
merger or consolidation beneficially own, immediately following the
effective date of such merger, consolidation, acquisition or other
transaction, securities representing less than 50% of the combined
voting power of the surviving corporation's then outstanding voting
securities.
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1.03
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“Commercialization” means
all steps that must be taken to put a Product on the market in the
Territory after all necessary regulatory approvals have been
obtained, including, without limitation, the manufacturing,
marketing, distribution and/or sublicensing of such
Product.
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1.04
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“Development” means
the process of creating and assembling the data and files necessary
to obtain regulatory approval for a Product including, without
limitation, all preclinical and clinical research and trials on
such Product.
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1.05
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“Effective Date” means
20 January 2006.
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1.06
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“FDA” means
the Food and Drug Administration within the Department of Health
and Human Services of the United States.
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1.07
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“Field” means
all therapeutic indications.
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1.08
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“Government Rights” means
rights, if any, of the United States Government to the Patents
under Public Law 96-517 and Public Law 98-620, as amended or
augmented by other similar laws.
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1.09
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“Improvements” means
any and all new developments relating solely to Products made by or
arising out of the laboratories of Drs. John Burnett and Ondrej
Lisy during the three (3) year period following the Effective Date
of this Agreement, including improved methods of manufacture and
production techniques, and shall include, but not be limited to,
new or additional analogs of the Product, therapeutic indications
and developments intended to enhance the safety and efficacy of the
Product.
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1.10
“Know-How” means
all technical information and data, whether or not patented,
presently known or learned, invented, or developed by the Drs. John
Burnett and Ondrej Lisy that is useful in the Development and
Commercialization of a Product and is disclosed to NILE, to the
extent that such technical information and data are helpful for the
use or practice of the Patents or Know-How as permitted
herein.
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1.11
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“License Quarter” begins
on the Effective Date, and thereafter begins on the first day of
each January, April, July, and October during the
Term.
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1.12
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“License Year ”
begins on the Effective Date, and thereafter begins on the first
day of each January during the Term.
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1.13
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“Net Sales” means
the amount invoiced by NILE, its Affiliates or Sublicensee for sale
of a Product in the Territory to a third party, less the
following:
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(a)
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sales,
tariff duties, excise or use taxes directly imposed and with
reference to particular sales;
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(b)
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credits
for defective or returned Products;
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(c)
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regular
trade and discount allowances; and
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(d)
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bad
debt deductions actually written off during the accounting
period;
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Leasing,
lending, consigning or any other activity by means of which a
third party acquires the right to possession or use of a
Product will be considered a sale for the purpose of
determining Net Sales.
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1.14
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“NDA” shall
mean a New Drug Application filed in the United States with the
FDA.
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1.15
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“Patent or Patents” means
the issued United States and foreign patents and the pending
applications set forth in Exhibit A, together with any and all
substitutions, extensions, divisionals, continuations,
continuations-in-part (to the extent that the subject matter is
disclosed and enabled in the parents), or foreign counterparts of
such patent applications and patents which issue thereon any where
in the world, including reexamined and reissued
patents.
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1.16
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“Phase II” means
a human clinical trial, the principal purpose of which is to
evaluate the effectiveness of the Product for a particular
indication in patients with the disease and to determine the common
short-term side effects and risks associated with the Product as
required in 21 C.F.R. §312. A Phase II study shall be deemed
to have been initiated when the first patient has been dosed with
the drug substance.
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1.17
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“Phase III” means
expanded controlled and uncontrolled human clinical trials
performed after Phase II evidence suggesting effectiveness of the
Product has been obtained, and is intended to gather the additional
information about effectiveness and safety that is needed to
evaluate the overall benefit-risk relationship of the Product and
to provide an adequate basis for physician labeling, as required in
21 C.F.R. §312. A Phase III study shall also include any other
human clinical trial intended to provide the substantial evidence
of efficacy necessary to support the filing of an approvable NDA
(such as a combined Phase II/Phase III study, or any Phase
III study in lieu of a Phase II study) (a “Pivotal
Study”), whether or not such study is a traditional Phase III
study. A Phase III study shall be deemed to have been initiated
when the first patient has been dosed with the drug
substance.
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1.18
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“Product” means
any method, service or product within the Field, the manufacture,
use, offer for sale or sale of which would infringe the Patent
rights.
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1.19
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“Reasonable Commercial Efforts”
means
efforts consistent with those used by comparable biotechnology
companies in the United States in research and development projects
for therapeutic methods or compositions deemed to have commercial
value comparable to the Product.
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1.20
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“Reports” means
written summaries for each Product generally describing NILE's
efforts with respect to Development and Commercialization of the
Product, including:
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(a)
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tests
and research completed;
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(b)
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any
filings made with any regulatory authorities;
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(c)
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any
regulatory approvals received;
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(d)
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a
response to any comments that MAYO have made to any earlier Report,
including NILE's rationale for rejecting any suggestion contained
in such comments;
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(e)
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reports
or minutes of any formal meetings with regulatory authorities,
whether convened in person or otherwise; and
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(f)
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any
other major regulatory event, including but not limited to,
placement of a “clinical hold” on a trial.
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1.21
“Sublicensee” means
an entity to 'whom NILE sublicenses the right to offer for sale or
sell the Products in the Territory for the Field.
1.22
“Successful Completion” of
a Phase III clinical trial shall mean a clinical trial that yields
data that is sufficiently statistically significant to permit NILE
to file a NDA.
1.23
“Valid Claim” means
an issued claim of any unexpired patent or claim of any pending
patent application included among the Patents, which has not been
held unenforceable, unpatentable or invalid by a decision of a
court or governmental body of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, which has not
been rendered unenforceable through disclaimer or otherwise, and
which has not been lost through an interference proceeding or
abandoned.
1.24 “Territory”
means world-wide.
Article 2 - Development and Commercialization
2.01
Agreements of Nile .
NILE agrees to use its commercially reasonable efforts to implement
a program of Development and Commercialization of the Product as
soon as practically possible. To achieve this goal, NILE agrees
to:
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(a)
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conduct
a reasonable research and commercial development program to develop
a Product;
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(b)
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expend
reasonable amounts towards the research and development of such
Products;
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(c)
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diligently
pursue worldwide regulatory approval of a Product;
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(d)
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commence
marketing of a Product within [***] following regulatory approval
in the United States.
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(e)
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comply
with all applicable laws in performing its obligations under this
Agreement, including in connection with obtaining the regulatory
approvals; and
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(f)
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perform
in good faith all of its obligations under this
Agreement.
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2.02
Management .
NILE and its Affiliates shall assemble a management team, which
shall include:
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(a)
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a
management team with relevant drug development experience;
and
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(b)
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a
Board of Directors initially consisting initially of up to five
members.
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2.03
Scientific Advisory Board .
NILE will assemble a Scientific Advisory Board (“SAB”)
consisting of experienced thought leaders in the area of Congestive
Heart Failure. Dr. John Burnett shall serve as the Chairman of the
SAB, subject to restrictions, if any, of MAYO's Conflict of
Interest Committee, and subject to his reasonable availability.
NILE shall compensate MAYO for Dr. Burnett's Know-How in this role
at a rate of Fifty Thousand Dollars ($50,000.00) per annum, in
addition to reimbursement of reasonable travel expenses. This
amount shall be paid quarterly {i.e. by March 31st, June 30th,
September 30th and December 31st of each year) in equal
installments of Twelve Thousand Five Hundred Dollars ($12,500). It
is understood and agreed that Dr. Burnett will not be required to
expend more than a maximum of twenty-four (24) days per year in his
capacity as Chairman of the SAB,
2.04
Development Plans and Reports .
NILE agrees to provide MAYO with the Reports semi-annually, within
30 days of June 30th and December 31st, starting in the second
License Year. Such Reports shall be in sufficient detail for MAYO
to among other things:
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(a)
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determine
whether NILE is using Reasonable Commercial Efforts to pursue the
regulatory approvals;
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(b)
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determine
whether NILE is using Reasonable Commercial Efforts to develop a
Development plan; and
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(c)
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determine
whether a Development plan, once developed and implemented,
establishes that NILE is using its Reasonable Commercial Efforts
for Commercialization of a Product.
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2.05
Notification .
NILE agrees to notify MAYO within thirty (30) days if NILE
determines that all Development efforts have been terminated for
all Products in which case MAYO may terminate this Agreement and
the licenses granted hereunder without cause upon thirty (30) days
prior written notice.
2.06
Consultation Regarding Reports .
MAYO shall review the Reports and promptly inform NILE if MAYO
reasonably believes that the Development or Commercialization plans
presented in the Reports are not adequate for a Product. NILE and
MAYO will mutually confer, provided, however, notwithstanding
anything to the contrary herein, NILE has the final decision-making
authority.
2.07
Receipt of Regulatory Approval .
NILE shall notify MAYO within five (5) business days of receiving
official notice of any regulatory approval for any
Product.
Article 3 - Grant of Rights
3.01
Grant of Rights .
MAYO grants to NILE an exclusive, world-wide, royalty-bearing
license, with the right to sublicense pursuant to Section 3.06,
under the Patents and Improvements, and a nonexclusive right under
the Know-How to develop, make, have made, use, sell, import, offer
to sell and commercialize Products within the Territory and within
the Field.
3.02
Reservation of Rights .
The grant of rights in Section 3.01 is subject to the Government
Rights of the United States government, if any, in the Patents and
Know-How, and subject to MAYO' reservation of rights to make, have
made and use the Patents and Products on a royalty-free basis for
MAYO' and its Affiliates internal non-commercial clinical, research
and education programs.
3.03
All Other Rights Reserved .
Except as granted in Section 3.01, or as otherwise expressly
granted herein, no other license is granted by MAYO under any
intellectual property rights owned or controlled by MAYO, including
any patents, know-how, copyrights, proprietary information, and
trademarks. All such rights are expressly reserved by MAYO. Except
as provided herein, NILE acknowledges that in no event will this
Agreement be construed as an assignment by MAYO to NILE of any
intellectual property rights.
3.04
Confidentiality .
During the Term, and for a period of three years thereafter, each
Party hereto agrees to keep confidential by not disclosing to any
third party any information (i) relating to this Agreement,
including the terms and conditions thereof, or (ii) disclosed by
one Party (the “Disclosing Party”) to the other (the
“Receiving Party”). The Parties may use this
information solely as necessary for complying with the terms and
conditions of this Agreement. The obligations of non¬disclosure
and non-use will not apply when and to the extent such
information:
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(a)
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becomes
part of the public domain through no action or fault of the
Receiving Party; or
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(b)
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was
in the Receiving Party's possession before disclosure by the
Disclosing Party, as demonstrated by written records, and was not
acquired, directly or indirectly, from the Disclosing Party;
or
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(c)
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was
received by the Receiving Party from a third party having a legal
right to transmit such information.
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At
MAYO's request, NILE will cooperate fully with MAYO, except
financially, in any legal actions taken by MAYO to protect its
rights in the Patents and Know-how disclosed
hereunder.
For
avoidance of doubt, any violation of the obligations stated in
this Section 3.04 constitutes a material breach of this
Agreement.
3.05
Availability of Product to MAYO .
Once a Product becomes commercially available, to the extent
permitted by law, NILE will provide Products to MAYO and their
Affiliates solely for it and their use for internal clinical,
research and education programs in the Field at most favored nation
pricing, i.e. no more than the lowest price available to NILE's
commercial customers for the Products for use in the
Field.
3.06
Sublicensee Actions .
Nile may enter into sublicensing agreements under the Patents. Nile
shall not receive, or agree to receive, anything of value in lieu
of cash or equity as consideration from a third party under a
sublicense agreement (excluding (a) any amounts paid to NILE
specifically designated for clinical research and development of
the Product, or (b) purchases of debt or equity securities of
NILE), without the prior written approval of MAYO. Nile agrees that
any sublicense agreement shall (i) contain provisions at least as
favorable to MAYO for the protection of MAYO's rights and the
limitation of MAYO's liability exposure as the terms of this
Agreement, including without limitation with respect to name use,
limitation of liability and indemnification, and development and
commercialization obligations commensurate in scope as those set
forth for Nile in this Agreement, (ii) to the fullest extent
applicable, contain all rights and obligations due to MAYO
contained in this Agreement, (iii) name MAYO as a third party
beneficiary and (iv) not permit the sublicensee to grant further
sublicenses. Nile shall (i) be and remain responsible for the
performance by such sublicensee with the terms of this Agreement,
and any action by a sublicensee that would, if conducted by Nile,
be a breach of this Agreement, shall be deemed a breach of this
Agreement by Nile, and (ii) ascertain, calculate, audit and collect
all royalties that become payable by such sublicensee hereunder and
take appropriate enforcement action against such Sublicensee for
any failure to pay or to properly calculate payments. Any purported
sublicense in violation of this Section 3.06 shall be
void.
Nile
shall furnish to MAYO a true and complet
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