TECHNOLOGY LICENSE AGREEMENTIP Intellectual Property License Assignment Agreement |
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Search IP Intellectual Property License Assignment Agreement by:
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.
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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.
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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
