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RESEARCH AND LICENSE
AGREEMENT
This
Agreement, effective as of August 10, 1998 (the
“Effective Date”), is by and between:
The
South Alabama Medical Science Foundation (hereinafter
“SAMSF”), a corporation organized and existing under
the laws of the State of Alabama and having a place of business at
307 University Boulevard, Mobile, Alabama 36688-0002.
Mindset
Limited (hereinafter “CORPORATION”), a corporation
involved in healthcare research, organized and existing under the
laws of the British Virgin Islands, having an office at 1 Beit
Eshel St., Old Katamon, Jerusalem 93227, ISRAEL.
WHEREAS,
Dr. Miguel A. Pappolla (hereinafter “the SAMSF
Scientist”) and/or Dr. Blas Frangione and Dr. Jorge
Ghiso have made certain inventions relating to use of melatonin and
melatonin analogs in the prevention or treatment of amyloid-related
disorders and in the use of melatonin analogs as anti-oxidants, all
as more particularly described in pending U.S. patent applications
owned by SAMSF and/or New York University, identified in annexed
Appendix I and forming an integral part hereof (hereinafter
“the Pre-Existing Inventions”);
WHEREAS,
SAMSF is willing to perform the SAMSF Research Project (as
hereinafter defined);
WHEREAS,
CORPORATION is prepared to sponsor the SAMSF Research
Project;
WHEREAS,
CORPORATION has a non-exclusive license agreement with Mayo
Foundation for Medical Education and Research(“MAYO”),
effective date October 24, 1997
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(hereinafter
“the MAYO license”) for the use of Tg 2576 transgenic
mice and related mice as defined in the MAYO license as
“Licensed Technology” (hereinafter “the MAYO
mice”) for the development of commercial technology, said
license being without the right to sublicense;
WHEREAS,
SAMSF desires to use the MAYO mice on a subcontractual basis in the
course of the SAMSF Research Project;
WHEREAS,
subject to the terms and conditions hereinafter set forth, SAMSF is
willing to grant to CORPORATION and CORPORATION is willing to
accept from SAMSF a License (as hereinafter defined);
NOW,
THEREFORE, in consideration of the mutual promises and agreements
contained herein, the parties hereto hereby agree as
follows:
a.
“Calendar Year” shall mean any consecutive period of
twelve months commencing on the first day of January of any
year.
b.
“Corporation Entity” shall mean any company or other
legal entity (including affiliates or subsidiaries) which controls,
or is controlled by, or is under common control with, CORPORATION;
control means the holding of twenty five and one tenth percent
(25.1%) or more of (i) the capital and/or (ii) the voting
rights and/or (iii) the right to elect or appoint
directors.
c.
“Date of First Commercial Sale” shall have the meaning
set forth in Section 7.b. hereof.
d.
“Field” shall mean research, development and testing
within pharmaceutical, diagnostic and biotechnological development
programs in the field of Alzheimer’s Disease and other
central nervous system and neurodegenerative diseases.
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e.
“License” shall mean the exclusive worldwide license to
practice the SAMSF Research Technology (as hereinafter defined) for
the development, manufacture, use, import and sale of the Licensed
Products (as hereinafter defined).
f.
“Licensed Products” shall mean all materials and
technologies, including, without limitation, rodents or other
transgenic animals, products, drugs, therapeutic agents and
therapeutic methods covered by a claim of any unexpired SAMSF
Patent (as hereinafter defined) which has not been disclaimed or
held invalid by a court of competent jurisdiction from which no
appeal has been or can be taken.
g.
“Net Sales” shall mean the CORPORATION’S and its
sublicensees’ billing for Licensed Products and Licensed
Processes produced hereunder less the sum of the
following:
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trade, case and quantity credits, discounts, refunds or
rebates;
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allowances or credits for
returns;
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sales taxes (including value-added
tax).
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h.
“SAMSF Know-How” shall mean the Pre-Existing Inventions
and any information and materials including, but not limited to,
pharmaceutical, chemical, biological and biochemical products,
technical and non-technical data, materials, methods and processes
and any drawings, plans, diagrams, specifications, software, and/or
other documents containing such information, discovered, developed
or acquired by, or on behalf of SAMSF investigators during the term
and in the course of the Research Project, with the exception of
any such know-how which is Corporation Know-How as hereinafter
defined.
i.
“CORPORATION Know-How” shall mean any information and
materials including, but not limited to, pharmaceutical; chemical,
biological and biochemical products,
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technical and
non-technical data, materials, methods and processes and any
drawings, plans, diagrams, specification, software and/or other
documents containing such information discovered, developed or
acquired by employees of CORPORATION during the term and in the
course of the Research Project.
j.
“SAMSF Patents” shall mean all United States and
foreign patents and patent applications, and any divisions,
continuations, in whole or in part, reissues, renewals and
extensions thereof, and pending applications therefor:
(1) which
claim Pre-Existing Inventions and which are identified on annexed
Appendix I; or
(2) which
claim inventions that are made, in whole or in part, as a result of
the research conducted through SAMSF during the term and in the
course of the Research Project; with the exception of all such
patents which are CORPORATION Patents as hereinafter
defined.
k.
“CORPORATION Patents” shall mean all United States and
foreign patents and patent applications, and any divisions,
continuations, in whole or-in part, reissues, renewals and
extensions thereof, and pending applications therefor which claim
inventions that are made, in whole or in part, by
CORPORATION.
l.
“Payment Term” shall mean the period of time commencing
on the Effective Date and continuing on a country-by-country basis,
if not previously terminated under the terms of this Agreement, for
fifteen (15) years) from the Date of First Commercial Sale in
such country or until the expiration date of the last to expire of
the SAMSF Patents whichever shall be later.
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m.
“Research Period” shall mean the 3-year period
commencing on the Effective Date hereof and any extension thereof
as to which SAMSF and CORPORATION shall mutually agree in
writing.
n.
“Research Project” shall mean the investigations at
SAMSF during the Research Period into the Field under the
supervision of the SAMSF Scientist in accordance with the research
program (as sponsored by CORPORATION), and described in annexed
Appendix II, which forms an integral part hereof.
o.
“Research Technology” shall mean all SAMSF Patents,
SAMSF Know-How, CORPORATION Patents and CORPORATION
Know-How.
p.
“CORPORATION Research Technology” shall mean all
CORPORATION Patents and all CORPORATION Know-How.
q.
“SAMSF Research Technology” shall mean all SAMSF
Patents and all SAMSF Know-How.
This
Agreement shall be effective as of the Effective Date and shall
remain in full force and effect until expires or is terminated in
accordance with Section 17 hereof.
3.
Performance of the Research Project
a.
In consideration of the sums to be paid to SAMSF as set forth in
Section 4 below, SAMSF undertakes to perform the Research
Project under the supervision of the SAMSF Scientist during the
Research Period. If, during the Research Period the SAMSF Scientist
shall cease to supervise the Research Project, and SAMSF has not
designated a replacement within 45 days, CORPORATION shall have the
option to terminate its funding of the SAMSF Research Project.
CORPORATION shall promptly advise SAMSF in writing if CORPORATION
so
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elects. Such
termination of funding pursuant to this Section 3.a. shall not
terminate this Agreement. Nothing herein contained shall be deemed
to impose an obligation on SAMSF to find a replacement for
the
b.
Nothing contained in this Agreement shall be construed as a
warranty on the part of SAMSF that any results or inventions will
be achieved by the Research Project, or that the Research
Technology and/or any other results or inventions achieved by the
Research Project, if any, are or will be commercially exploitable
and furthermore SAMSF makes no warranties whatsoever as to the
commercial or scientific value of the Research Technology and/or as
to any results which may be achieved in the Research
Project.
c.
Within sixty (60) days after the end of each year of the
Research Period, SAMSF shall prepare a written report summarizing
the results of the work conducted on the Research Project during
the preceding year, and submit such report to CORPORATION. SAMSF
shall also prepare and submit to CORPORATION quarterly summaries of
such work conducted during the previous quarter. It is hereby
agreed that such written report and quarterly summaries shall
include reports on all clinical trials carried out during the
relevant period.
d.
SAMSF will have full authority and responsibility for its part of
the Research Project. Students and SAMSF employees who work on the
Research Project will do so as in those roles and not as employees
of CORPORATION.
e.
Corporation shall be free to undertake any development of
technology not covered by the Research Project. Corporation may
elect to perform research and development in-house, through other
academic collaborations, or through outsourcing.
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4.
Funding of the Research Project
a.
As compensation to SAMSF for work to be performed on the SAMSF
Research Project during the Research Period, subject to any earlier
termination of the Research Project pursuant to Section 3.a.
hereof, CORPORATION will pay SAMSF the total sum of $79,000 (USD$)
per year, payable in 2 equal installments of $39,500 each,
commencing upon the Effective Date and according to the following
schedule:
$39,500 on the
Effective Date, and
$39,500 after each six month (6) interval
thereafter.
b.
Nothing in this Agreement shall be interpreted to prohibit SAMSF
(or the SAMSF Scientists) from obtaining additional financing or
research grants for the Research Project from government or
not-for-profit agencies, which grants or financing may render all
or part of the Research Project and the results thereof subject to
the patent rights of the U.S. Government and its agencies, as set
forth in Title 35 U.S.C. 200 et seq. so long as the terms of such
grants or financing do not preclude any results of the Research
Project being included in the License.
a.
Subject to the terms specified hereunder, it is hereby agreed that
all right, title and interest, in and to the CORPORATION Research
Technology, and in and to any drawings, plans, diagrams,
specifications, software, and other documents containing any of the
CORPORATION Research Technology shall vest solely in
CORPORATION.
b.
Subject to the License granted to CORPORATION hereunder, it is
hereby agreed that all right, title and interest, in and to the
SAMSF Research Technology, and in and to any drawings, plans,
diagrams, specifications, software, or other documents containing
any of
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the SAMSF
Research Technology, shall vest solely in SAMSF. At the request of
SAMSF, CORPORATION shall take all steps as may be necessary to give
full effect to any said right, title and interest of SAMSF
including, but not limited to, the execution of any documents that
may be required to record such right, title and interest with the
appropriate agency or government office.
6.
Patents and Patent Applications
a.
CORPORATION shall, simultaneously with the signing of this
Agreement pay SAMSF a Fee in the amount of $10,000 (USD$) related
to all non-provisional patent applications that have been filed in
the name of Dr. Miguel Pappolla related to the use of
melatonin and melatonin analogs in Alzheimer’s
Disease.
b.
SAMSF will promptly disclose to CORPORATION in writing any related
inventions which constitute potential SAMSF Patents.
c.
The Patent applications pending at the date hereof shall continue
to be maintained by Jaeckle Fleischmann & Mugel, LLP or such
other patent counsel selected by SAMSF and CORPORATION. All other
patent applications shall be filed and prosecuted and maintained by
Browdy and Neimark or other patent counsel selected by SAMSF and
CORPORATION. Copies of all such patent applications and patent
office actions shall be forwarded to CORPORATION. SAMSF and
CORPORATION shall each also have the right to have such patent
applications and patent office actions independently reviewed by
other patent counsel separately retained by SAMSF or CORPORATION at
the cost of SAMSF or CORPORATION, as the case may be, and upon
prior notice to and with the consent of the other party hereto,
such consent not to be unreasonably withheld.
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d.
The CORPORATION will promptly disclose to SAMSF any inventions
which relate to the SAMSF Research Technology and which are
conceived by employees or consultants of CORPORATION.
e.
[Upon prior written approval by CORPORATION, all applications and
proceedings with respect to the SAMSF Patents shall be filed,
prosecuted and maintained by SAMSF at the expense of CORPORATION.
Against the submission of invoices, CORPORATION shall reimburse
SAMSF for all costs and fees incurred by SAMSF during the team of
this Agreement, in connection with the filing, maintenance,
prosecution and protection and the like of the SAMSF
Patents.
f.
All applications and proceedings with respect to the CORPORATION
Patents shall be filed, prosecuted and maintained by CORPORATION at
the expense of CORPORATION.
g.
SAMSF and CORPORATION shall assist, and cause their respective
investigators to assist each other, in assembling inventorship
information and data for the filing and prosecution of patent
applications on inventions pertaining to the Research
Technology.
h.
If, at any time during the term of this Agreement, CORPORATION
decides that it is undesirable, as to one or more countries, to
prosecute or maintain any patents or patent applications within the
SAMSF Patents, it shall give prompt written (within thirty days
(30)) notice thereof to SAMSF, and upon receipt of such notice,
CORPORATION shall be released from its obligations to bear all of
the expenses to be incurred thereafter as to such countries in
conjunction with such patent(s) or patent application(s) and such
patent(s) or application(s) shall be deleted from the Research
Technology and SAMSF shall be free to grant rights in and to such
subject matter deleted from the Research Technology in such
countries to
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third parties,
without further notice or obligation to CORPORATION, and the
CORPORATION shall have no rights whatsoever to exploit such subject
matter deleted from the Research Technology in such
countries.
i.
Nothing herein contained shall be deemed to be a warranty by
SAMSF
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that CORPORATION can or will be able
to obtain any patent or patents on any patent application or
applications in the CORPORATION Patents or any portion thereof, or
that any of the CORPORATION Patents will afford adequate or
commercially worthwhile protection, or
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ii)
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that SAMSF can or will be able to
obtain any patent or patents on any patent application or
applications in the SAMSF Patents or any portion thereof, or that
any of the SAMSF Patents will afford adequate or commercially
worthwhile protection, or
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iii)
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that the manufacture, use, or sale
of any element of the Research Technology or any resulting Product
will not infringe any patent(s) of a third party.
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a.
Subject to the terms and conditions hereinafter set forth and
subject to all United States Government rights whether now existing
or arising after the date hereof, SAMSF hereby grants to
CORPORATION and CORPORATION hereby accepts from SAMSF the
License.
b.
The License granted to CORPORATION in Section 7.a. hereto
shall commence upon the Effective Date and shall remain in force on
a country-by-country basis, if not previously terminated under the
terms of this Agreement, for fifteen (15) years from the First
Commercial Sale in such country or until the expiration date of the
last to expire of the SAMSF Patents whichever shall be
later.
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c.
CORPORATION shall be entitled to grant sublicenses under the
License on terms and conditions in compliance and not inconsistent
with the terms and conditions of this Agreement (except that the
rate of royalty may be at higher rates than those set forth in this
Agreement) (i) to a Corporation Entity or (ii) to other third
parties for consideration and in an arms-length transaction. All
sublicenses shall only be granted by CORPORATION under a written
agreement a copy of which shall be provided by CORPORATION to SAMSF
as soon as practicable after the signing thereof. Each sublicense
granted by CORPORATION hereunder shall be subject and subordinate
to the terms and conditions of any License Agreement and shall
contain (inter-alia) the following provisions:
(1) the
sublicense shall expire automatically on the termination of the
License;
(2) the
sublicense shall not be assignable, in whole or in part;
(3) the
sublicensee shall not grant further sublicenses; and
(4) both
during the term of the sublicense and thereafter the sublicensee
shall agree to a confidentiality obligation similar to that imposed
on CORPORATION in Section 10 below, and that the sublicensee
shall impose on its employees, both during the terms of their
employment and thereafter, a similar undertaking of
confidentiality; and
(5) the
sublicense agreement shall include the text of Sections 15 and
16 of this Agreement and shall state that SAMSF is third party
beneficiary of such sublicense agreement for the purpose of
enforcing such indemnification and insurance provisions.
d.
SAMSF reserves the right to use and distribute tangible research
products to third parties for non-commercial, research
use.
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a.
In consideration for the License granted herein, and during the
Payment Term, with respect to each Licensed Product, CORPORATION
shall pay to SAMSF a royalty of *** of the Net Sales of CORPORATION
or of Corporation Entity or of a licensee or sublicensee of
CORPORATION or Corporation Entity. CORPORATION shall inform SAMSF
in writing of the Date of First Commercial Sale with respect to
each Licensed Product in each country as soon as practicable after
making of each such first commercial sale.
b.
For the purpose of computing the royalties due to SAMSF hereunder,
the year shall be divided into two parts ending on June 30 and
December 31. Not later than ninety (90) days after each
December and June in each Calendar Year during the Payment Term,
CORPORATION shall submit to SAMSF a full and detailed report of
royalties or payments due SAMSF under the terms of this Agreement
for the preceding half year (hereinafter “the Half-Year
Report”), setting forth the Net Sales upon which such
royalties are computed and including at least
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quantity of Products used, sold, transferred or otherwise disposed
of;
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the
selling price of each Product;
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the
deductions permitted under subsection 1.g. hereof to arrive at Net
Sales; and
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the
royalty computations and subject of payment.
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If no royalties
or other payments are due, a statement shall be sent to SAMSF
stating such fact. Payment of the full amount of any royalties or
other payments due to SAMSF for the preceding half year shall be
made within ninety (90) days of each Half-Year Report on
royalties and
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payments.
CORPORATION shall keep for a period of at least six (6) years
after the date of entry, full, accurate and complete books and
records consistent with sound business and accounting practices and
in such form and in such detail as to enable the determination of
the amounts due to SAMSF from CORPORATION pursuant to the terms of
this Agreement.
c.
Within ninety (90) days after the end of each Calendar Year,
commencing on the Date of First Commercial Sale CORPORATION shall
furnish SAMSF with a report (hereinafter “the Annual
Report”), certified by any CORPORATION’S President or
Chief Financial Officer, relating to the royalties and other
payments due to SAMSF pursuant to this Agreement in respect of the
Calendar Year covered by such Annual Report and containing the same
details as those specified in Section 8.b. above in respect of the
Half-Year Report.
d.
On reasonable notice and during regular business hours, SAMSF, or
the authorized representative of SAMSF shall each have the right to
inspect the books of accounts, records and other relevant
documentation of CORPORATION or of Corporation Entity and the
licensees or sublicensees of CORPORATION insofar as they relate to
the production, marketing and sale of the Products, in order to
ascertain or verify the amount of royalties and other payments due
to SAMSF hereunder, and the accuracy of the information provided to
SAMSF in the aforementioned reports. Should such inspection lead to
the discovery of a greater than ten percent (10%) discrepancy in
reporting to SAMSF’s detriment, CORPORATION agrees to pay the
full cost of such inspection.
a.
Royalties and other payments due to SAMSF hereunder shall he paid
to SAMSF in United States dollars(USD$). Any such royalties on or
other payments relating to transactions in a foreign currency shall
be converted into United States dollars(USD$) based on
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the closing
buying rate of the Morgan Guaranty Trust Company of New York
applicable to transactions under exchange regulations for the
particular currency on the last business day of the accounting
period for which such royalty or other payment is due.
b.
CORPORATION shall be responsible for payment to SAMSF of all
royalties due on sale, transfer or disposition of Products by
Corporation Entity or by the licensees of CORPORATION or of
Corporation Entity.
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10.
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Confidential
Information
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a.
Except as otherwise provided in Section 10.c and
Section 11 below, [SAMSF shall maintain any and all of the
Research Technology in confidence and shall not release or disclose
any tangible or intangible component thereof to any third party
without first receiving the prior written consent of CORPORATION to
said release or disclosure.]
b.
Except as otherwise provided in Section 10.c. and 10.d. below,
CORPORATION shall maintain any and all of the SAMSF Research
Technology in confidence and shall not release or disclose any
tangible or intangible component thereof to any third party without
first receiving the prior written consent of SAMSF to said release
or disclosure.
c.
The obligations of confidentiality on SAMSF and CORPORATION set
forth in Section 10a. and b. respectively shall not apply to
any component of the Research Technology which was part of the
public domain prior to the Effective Date of this Agreement or
which becomes a part of the public domain not due to some
unauthorized act by or omission of the receiving party after the
effective date of this Agreement or which was disclosed to the
receiving party by a third party who has the right to make such
disclosure.
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d.
The provisions of Section 10.b. notwithstanding, CORPORATION
may disclose the SAMSF Research Technology to third parties who
need to know the same in order to secure regulatory approval for
the sale of Products.
a.
Prior to submission for publication of a manuscript describing the
results of any aspect of the Research Project, SAMSF shall send
CORPORATION a copy of manuscript to be submitted, and shall allow
CORPORATION thirty (30) days from the date of such mailing to
determine whether manuscript contains such subject matter for which
patent protection should be sought prior to publication of
manuscript, for the purpose of protecting an invention made by the
SAMSF Scientist during the course and within the term of the
Research Project. Should CORPORATION believe the subject matter of
manuscript contains a patentable invention, then, prior to the
expiration of such 30-day period from the mailing date of
manuscript to CORPORATION by SAMSF and CORPORATION shall give
written notification to the sender of the manuscript of its
determination that such manuscript contains patentable subject
matter for which patent protection should be sought.
b.
After the expiration of such 30-day period from the date of mailing
such manuscript to CORPORATION, unless SAMSF has received the
written notice specified above from CORPORATION, SAMSF shall be
free to submit manuscript for publication to publish the disclosed
research results in any manner consistent with academic
standards.
c.
Upon receipt of such written notice from CORPORATION, SAMSF will
thereafter delay submission of the manuscript for an additional
period of up to sixty (60) days to permit the preparation and
filing in accordance with Section 6. hereof of a U.S. patent
application by CORPORATION on the subject matter to be disclosed in
such manuscript. After
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expiration of
such 60-day period, or the filing of a patent application on each
such invention, whichever shall occur first, SAMSF shall be free to
submit the manuscript and to publish the disclosed
results.
d.
All such publications shall within the body of the same contain a
written acknowledgment of CORPORATION’s support of the
Research Project. In addition, Dr. Daniel Chain and any other
employees of CORPORATION involved in the Research Project shall be
recognized in any such publication as co-author(s) or in a written
acknowledgment as shall be determined on a case by case in
accordance with accepted principles for determining authorship of
scholarly publications.
12.
Infringement of CORPORATION Patents
a.
In the event that the SAMSF acquires information that a third party
is infringing one or more of the CORPORATION Patents, shall
promptly notify CORPORATION in writing of such
infringement.
b.
SAMSF shall cooperate and shall endeavor to cause the SAMSF
Scientist to cooperate with CORPORATION at the request of
CORPORATION, including by giving testimony and producing documents
lawfully requested, in the prosecution of any suit by CORPORATION
for infringement of the CORPORATION Patents; provided, that
CORPORATION shall pay all reasonable expenses (including
attorneys’ fees) incurred by SAMSF in connection with such
cooperation.
13.
Infringement of SAMSF Patent
a.
In the event a party to this Agreement acquires information that a
third party is infringing one or more of the SAMSF Patents, the
party acquiring such information shall promptly notify the other
parties to the Agreement in writing of such
infringement.
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