Mayo Foundation for Medical
Education and Research
Transgenic Animal Non-Exclusive License and
Sponsored Research Agreement (LSRA)
Article 1.00 —
Preliminary Provisions.
1.01
DATE. The Effective Date
of this LSRA is October 24, 1997.
1.02
PARTIES. There are two
parties to this LSRA. They are:
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(a)
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MAYO FOUNDATION FOR MEDICAL
EDUCATION AND RESEARCH, a Minnesota charitable corporation, located
at 200 First Street SW, Rochester, Minnesota 55905-0001 (called
“MAYO” in this LSRA).
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(b)
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MINDSET, Ltd., located at 340 West
86 th Street, Suite 4B, New York, New
York 10024-3166 (“LICENSEE” in this LSRA), with its
registered office located at Craigmuir Chambers, P.O. Box 71, Road
Town, Tortola, British Virgin Islands.
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(a)
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Prior to execution of this LSRA,
MAYO and the University of Minnesota (“MINNESOTA”)
shall have executed an exclusive Technology License Agreement for
use of certain transgenic mice and related technologies as models
for Alzheimer’s Disease and other neurodegenerative diseases,
for commercial uses and other uses.
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(b)
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MAYO believes that dissemination of
these transgenic mice to researchers is of potential great benefit
to present and future patients having Alzheimer’s Disease and
other neurodegenerative diseases.
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(c)
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MAYO desires to sublicense the
transgenic mice and certain related technologies to third parties
for use as models in development of therapeutic and other agents
for Alzheimer’s Disease and other neurodegenerative diseases,
to the benefit of humanity.
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(d)
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MAYO desires to undertake certain
research activities directed to further characterizing the
transgenic mice and to obtaining and further disseminating
transgenic mice having desired genotypes for use in
neurodegenerative disease research.
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(e)
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LICENSEE desires to nonexclusively
license certain of the above-referenced transgenic mice.
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Article 2.00 —
Definitions
When used
herein, the following terms shall have the meanings set forth
below. All reference to the singular shall include the plural and
vice-versa.
2.01 169
PATENT RIGHTS. means U.S.
Patent Number 5,455,169, issued October 3, 1995, and all
patents and applications corresponding thereto throughout the
world, including but not limited to, author certificates, inventor
certificates, improvement patents, utility certificates and models
and certificates of addition, and including any parent
applications, divisions, renewals, continuations,
continuations-in-part, extensions or re-issues thereof.
2.02
AFFILIATE. means a legal
entity controlled by, or controlling, another legal entity, or
which is an Affiliate of an Affiliate, or an Affiliate of an
Affiliate of an Affiliate, “Control” means direct or
indirect beneficial ownership of at least fifty (50) percent
of the voting stock of a corporation; direct or indirect ownership
of at least fifty (50) percent of the income of a legal
entity; or possession of at least fifty (50) percent of the
voting rights of the members of a nonprofit or nonstock
corporation. MAYO’s Affiliates include, but are not limited
to; Mayo Foundation; Rochester Methodist Hospital; Saint
Mary’s Hospital; Mayo Clinic Jacksonville, Florida; St.
Luke’s Hospital, Jacksonville, Florida; Mayo Clinic
Scottsdale, Arizona; Memorial Hospital-North, Scottsdale, Arizona;
Mayo Regional Practices, P.C., Decorah, Iowa; and Mayo Regional
Practices of Wisconsin, Ltd.
2.03
DEVELOPMENT PROGRAMS. means pharmaceutical, biotechnological and
diagnostic development programs in the field of Alzheimer’s
Disease and other central nervous system and neurodegenerative
diseases as performed by LICENSEE or its Affiliates.
2.04
DEVELOPMENT TECHNOLOGY. means all materials and technologies, including
without limitation rodents or other transgenic animals, products,
drugs, diagnostic reagents, diagnostic methods, therapeutic agents
and therapeutic methods, derived from or resulting from use
(including testing or screening of new or existing pharmaceutical
products or molecules) of the Licensed Technology, either directly
by LICENSEE or by others through rights granted by
LICENSEE.
2.05 FIELD
OF USE. means research,
development and testing within the Development Programs.
2.06 LICENSE
QUARTER. begins on the
date in Section 1.01 of this LSRA, and thereafter begins on
the first day of each January, April, July and October during the
term of this LSRA.
2.07 LICENSE
YEAR. begins on the date
in Section 1.01 of this LSRA, and thereafter begins on
the first day of each January during the term of this
LSRA.
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2.8 LICENSED
KNOW-HOW. means trade
secrets including technical information, whether or not patentable,
including but not limited to engineering, scientific, and practical
information and formulas; information about qualities, uses, and
sales methods and procedures; information about materials and
sources; blueprints, drawings, specifications, and other relevant
writings used in the design, manufacture, and sale of products,
processes, and methods in connection with the Licensed
Technology.
2.9 LICENSED
TECHNOLOGY. means
(a) mice of the Tg 2576 strain of the transgenic mouse model
described in Hsiao et al, Correlative Memory Deficils, A-Beta
Elevation and Amyloid Plaques in Transgenic Mice , as published
in Science on October 4, 1996, or in a U.S.
continuation-in-part patent application, filed June 17, 1996,
Serial No. 08/664,872 (the “CIP Application”),
which mice are (1) progeny of a cross of a Tg2576 N2 male with
a C57B6SJL female or (2) the progeny of a cross between
(Tg2576 N2 x C57B6SJL) male with a C57B6SJL female, (such mice
referred to herein as” Stock”); (b) progeny of the
Stock; and (c) certain transgenic mice that may result from
the Sponsored Research Activities (defined in Section 2.14
below).
2.10 MAYO
INFORMATION. means all
information embodied in the Licensed Technology and Licensed
Know-How, or expressly marked, labeled, referenced in writing, or
otherwise designated by MAYO as confidential, which is disclosed to
the LICENSEE by MAYO, relating in any way to MAYO’s markets,
customers, patents, inventions, products, procedures, designs,
plans, organization, employees, or business in general, but not
including:
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(a)
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information which, before disclosure
becomes part of the public domain through no action or fault of
LICENSEE; or
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(b)
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information which LICENSEE can show
by sufficient proof was in its possession before disclosure by MAYO
to the LICENSEE and was not acquired, directly or indirectly, from
MAYO; or
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(c)
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information which was received by
LICENSEE from a third party having a legal right to transmit such
information.
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2.11 MAYO
PATENT RIGHTS. means U.S.
Patent Application Number 08/189,064 filed January 27, 1994,
U.S. Patent Application Serial Number 08/644,691 filed May 10,
1996, U.S. Patent Application Serial Number 08/664,872 filed
June 17,1996, PCT Application Number US95/01088 (Publication
No. WO95/20666) filed January 27, 1995 and all patents and
applications thereof throughout the world, including but not
limited to, author certificates, inventor certificates, improvement
patents, utility certificates and models and certificates of
addition, and including divisions, renewals, continuations,
continuations-in-part, extensions or re-issues thereof.
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2.12 NET
SALES. means the amounts
received for the Development Technology by LICENSEE and its
Affiliates, assigns and licensees, in respect of the sale or
transfer of the Development Technology in the Territory, less the
following items to the extent they are paid or allowed and included
in the invoice price:
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(a)
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Credits allowed for Development
Technology returned or not accepted by customers;
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(b)
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Packaging, transportation and
prepaid insurance charges on shipments or deliveries to customers;
and
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(c)
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Taxes actually incurred and paid by
or on behalf of LICENSEE in connection with the sale or delivery of
Development Technology to customers.
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2.13
SPF. means specific
pathogen-free.
2.14
SPONSORED RESEARCH ACTIVITIES. means research carried out by MAYO or its
Affiliates directed to (1) characterizing the existing Tg 2576
mice, which are heterozygous for Transgene-2576, (2) developing
mice homozygous for Transgene-2576, and (3) developing pure
strains of mice, i.e.; mice having homogeneous genetic backgrounds,
into which Transgene-2576 has been bred. Mayo desires to undertake
these Sponsored Research Activities in order to potentially create
certain genotypes useful in neurodegenerative disease
research.
2.15
TERMINATION. of this LSRA
means the ending, expiration, rescission, or any other
discontinuation of this LSRA.
2.16
TERRITORY. means
throughout the universe.
2.17
TRANSGENE. means a
transgene, genetic construct or vector comprising an amyloid
precursor protein coding sequence operably joined to regulatory
sequence obtainable from a prion protein gene.
2.18
TRANSGENE-2576. means the
Transgene used to generate the Tg 2576 strain of mice described
above.
Article 3.00 — Grant
of Rights.
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(a)
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MAYO grants to LICENSEE a
non-exclusive license in the Territory within the Field of Use,
without the right to sublicense (except to its Affiliates), to use
and breed the Licensed Technology, and to use the Licensed
Know-How, under the Mayo Patent Rights, according to the terms of
this LSRA.
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(b)
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MAYO grants to LICENSEE a
non-exclusive license in the Territory, without the right to
sublicense (except to its Affiliates), to make, have made, use,
offer to sell and sell the Development Technology, under the Mayo
Patent Rights, according to the terms of this LSRA.
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(c)
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MAYO grants to LICENSEE a
non-exclusive sublicense in the Territory within the Field of Use,
without the right to sublicense (except to its Affiliates), to use
and breed the Licensed Technology under the 169 Patent
Rights,
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(d)
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Notwithstanding the above
Section 3.01 (a) and 3.01 (b), LICENSEE shall be entitled
to grant sublicenses to third parties to make, use, offer to sell,
and sell all Development Technology,
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3.02
CONFIDENTIALITY. LICENSEE
acknowledges that all Mayo Information is confidential and
proprietary to MAYO. LICENSEE agrees not to use any Mayo
Information for three (3) years after disclosure or three
(3) years after Termination of this LSRA, whichever is longer,
for any purpose other than as permitted or required under this
LSRA. LICENSEE also agrees not to disclose or to provide any Mayo
Information to any third party, and to take all reasonable measures
to prevent any such disclosure by its employees, agents,
contractors, or consultants during the term of this LSRA, and for
three (3) years after its Termination.
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(a)
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At
MAYO’s request, LICENSEE shall cooperate folly with MAYO,
except financially, in any legal actions taken by MAYO to protect
its rights in the Licensed Technology and in the Mayo
Information.
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(b)
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Any
violation of LICENSEE’S obligations stated in this
Section 3.02 is a Material Breach of this LSRA.
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3.03
DISCLOSURE OF KNOW-HOW. Within a reasonable time after execution of this
LSRA, MAYO shall make available to the LICENSEE the Licensed
Know-How, MAYO, however, owns the materials in which the Licensed
Know-How is embodied, including, but not limited to, prototypes,
blueprints, and plans.
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(a)
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MAYO will provide to LICENSEE three
(3) SPF breeder male mice and, depending on availability, up
to fifteen (15) male or female mice of strain Tg 2576 of the
Stock within 60 days of the Effective Date of this LSRA. In
the event that interest, in the form of signed license and
sponsored research agreements (such as this LSRA) received by MAYO,
exceeds MAYO’s ability to deliver Stock, then such Stock will
be provided on a first-come basis based on the date of receipt of
the signed license and sponsored research agreements. In the event
the projected delay shall exceed 30 days beyond the 60-day
estimated period, LICENSEE shall have the right to terminate this
LSRA.
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(b)
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Subject to availability, MAYO will
also provide to LICENSEE two (2) breeding pairs of mice
homozygous for Transgene-2576, and two (2) breeder males from
each pure strain into which Transgene-2576 has been bred, as such
mice may be developed by MAYO in the Sponsored Research
Program.
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(c)
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LICENSEE shall pay all costs
incurred for shipment of Licensed Technology by MAYO to LICENSEE.
MAYO at its sole discretion, and upon consultation with LICENSEE,
may choose the method of shipment, but in any case will undertake
reasonable efforts to ensure delivery of viable mice.
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(d)
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In
the event that LICENSEE becomes unable to breed the supplied Stock
due to death or unforeseen circumstances, provided that LICENSEE
shall have made reasonable efforts to breed the supplied mice
within a reasonable time following receipt of such mice from MAYO,
MAYO will, subject to availability, provide to LICENSEE a
reasonable number of additional Stock to replace the originally
supplied Stock.
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3.05
GENOTYPING. MAYO will use
reasonable efforts to provide LICENSEE, subject to availability,
breeding records and a protocol useful in genotyping the offspring
of the Stock. Any breeding records or nucleic acid probes provided
to LICENSEE by MAYO under this LSRA shall be used solely for
genotyping the Licensed Technology.
3.06
ACADEMIC RESEARCH. LICENSEE may release the Stock or progeny
thereof to academic researchers at nonprofit institutions and to
scientific researchers employed by the U.S. government, in each
case for research purposes only, provided that such release is made
under substantially the same terms as those set forth in
Exhibit A attached hereto. Any such agreement and terms shall
be strictly subject to approval by MAYO, which shall have sole
discretion for such approval.
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Article 4.00 —
Consideration and Royalties.
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A.
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LICENSE AND SPONSORED RESEARCH FEE.
LICENSEE shall pay MAYO License and Sponsored Research Fees as
follows:
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i.
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Upon the date of filing of the first
Investigational New Drug Application related to the Development
Technology with the U.S. Federal Drug Administration
(“FDA”) or similar application with a similar
non-United States regulatory agency in or for the European Economic
Community or Japan: TWO HUNDRED THOUSAND DOLLARS (US
$200,000)
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ii.
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Upon the date of filing of the first
New Drug Application related to the Development Technology with the
FDA or any such similar application with a similar non-United
States regulatory agency in or for the European Economic Community
or Japan: FOUR HUNDRED THOUSAND DOLLARS (US $400,000)
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iii.
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Upon the date of approval of the
first New Drug Application related to the Development Technology by
the FDA or approval of a similar application by a similar non-U.S.
regulatory agency in or for the European Economic Community or
Japan: NINE HUNDRED THOUSAND DOLLARS (US $900,000)
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B.
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These License and Sponsored Research
Fees provide LICENSEE with licensed rights granted in this LSRA
until expiration or Termination of this LSRA, and funds Sponsored
Research Activities for one year beyond the Effective
Date.
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4.02
ROYALTIES. LICENSEE, its
Affiliates and assigns shall, on the dates set forth in Section
5.01, pay to MAYO royalties on a country by country basis in an
amount equal to two and one-half percent (2.5%) of Net Sales of the
Development Technology.
4.03
TAXES. LICENSEE is
responsible for all taxes (other than net income taxes), duties,
import deposits, assessments, and other governmental charges,
however designated, which are now or hereafter will be imposed by
any authority in or for the Territory, (a) by reason of the
performance by MAYO of its obligations under this LSRA, or the
payment of any amounts by LICENSEE to MAYO under this LSRA;
(b) based on the Licensed Technology or Development Technology
or use of the Licensed Technology or Development Technology; or
(c) which relate to the import of the Licensed Technology or
Development Technology into any country within the
Territory.
4.04 NO
DEDUCTIONS. All payments
to be made by LICENSEE to MAYO under this LSRA represent net
amounts MAYO is entitled to receive, and shall not be subject to
any deductions or offsets for any reason whatsoever. If such
payments become subject to taxes, duties, assessments, or fees of
any kind levied in the Territory, such payments from
LICENSEE
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shall be
increased to the extent that MAYO actually receives the net amounts
due under this LSRA.
4.05 U.S.
CURRENCY. All payments to
MAYO under this LSRA shall be made by draft drawn on a United
States bank, and payable in United States dollars.
Article 5.00 —
Accounting and Reports.
5.01
PAYMENT. LICENSEE will
deliver to MAYO on or before the following dates: 1 February, 1
May, 1 August, and 1 N
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