Confidential Treatment has been
requested
for portions of this document marked with asterisks.
This Agreement,
effective as of August 10, 1998 (the “Effective
Date”), is by and between:
New York
University (hereinafter “NYU”), 550 First Avenue, New
York, N.Y. 10016
Mindset Limited
(hereinafter “CORPORATION”), a corporation 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”) of The South Alabama Medical Science Foundation
(“SAMSF”) and/or Dr. Blas Frangione and
Dr. Jorge Ghiso (hereinafter “the NYU Scientists”)
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 NYU, identified in annexed Appendix I
and forming an integral part hereof (hereinafter “the
Pre-Existing Inventions”);
WHEREAS, by a
Research and License Agreement made as of the tenth day of
August 1998 between SAMSF and Corporation (the “SAMSF
Agreement”), SAMSF has agreed to undertake the Research
Project (as hereinafter defined);
WHEREAS, subject
to the terms and conditions hereinafter set forth, NYU is willing
to grant to CORPORATION and CORPORATION is willing to accept from
NYU the 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 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 6.a. hereof.
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
d. “Field”
shall mean research, development and testing within pharmaceutical,
biotechnological and diagnostic development programs in the field
of Alzheimer’s Disease and other central nervous system and
neurodegenerative diseases, and in the field of all other possible
utilities for melatonin analogs.
e. “License”
shall mean the exclusive worldwide license to practice NYU’s
share in the University Research Technology (as hereinafter
defined) for the development, manufacture, use and sale of the
Licensed Products (as hereinafter defined).
f. “Licensed
Products” shall mean all products, drugs, diagnostic
reagents, diagnostic methods, therapeutic agents and therapeutic
methods covered by a claim of any unexpired UNIVERSITY Patents (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 total amount invoiced in connection
with sales of the Licensed Products to any person or entity that is
not a Corporation Entity or a licensee or sublicensee of
CORPORATION or a Corporation Entity, after deduction of all of the
following to the extent applicable to such sales:
|
|
i)
|
|
all
trade, case and quantity credits, discounts, refunds or
rebates;
|
|
|
|
|
|
|
|
ii)
|
|
allowances or credits for
returns;
|
|
|
|
|
|
|
|
iii)
|
|
sales commissions; and
|
|
|
|
|
|
|
|
iv)
|
|
sales taxes (including value-added
tax).
|
h. “University
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 students or employees of SAMSF
pursuant to the SAMSF Agreement 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, 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, or on behalf of
students or employees of Corporation during the term and in the
course of the Research Project.
j. “UNIVERSITY
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:
- 2 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
|
|
(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, by students or employees of 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 students or employees of
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 UNIVERSITY Patents, whichever shall be later.
m. “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, described in
annexed Appendix II, which forms an integral part
hereof.
n. “Research
Technology” shall mean all UNIVERSITY Patents, UNIVERSITY
Know-How, CORPORATION Patents and CORPORATION Know-How.
o. “CORPORATION
Research Technology” shall mean all CORPORATION Patents and
all CORPORATION Know-How.
p. “UNIVERSITY
Research Technology” shall mean all UNIVERSITY Patents and
all UNIVERSITY Know-How.
This Agreement
shall be effective as of the Effective Date and shall remain in
full force and effect until it expires or is terminated in
accordance with Section 15 hereof.
a. 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 UNIVERSITY
Research Technology, and in and to
- 3 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
any drawings,
plans, diagrams, specifications, software, or other documents
containing any of the UNIVERSITY Research Technology, shall vest
solely in SAMSF and/or NYU.
4.
Patents and Patent Applications
a. At the
initiative of CORPORATION or NYU, the parties shall consult with
each other regarding the prosecution of all patent applications
with respect to the University Research Technology. Any patent
applications relating to the Pre-Existing Inventions shall be
filed, prosecuted and maintained by Jaeckle, Fleischmann &
Mugel, LLP or such other patent counsel selected by SAMSF and
CORPORATION. All other patent applications shall be filed,
prosecuted and maintained by the law firm of Browdy and Neimark or
by other patent counsel jointly selected by NYU and CORPORATION.
Copies of all such patent applications and patent office actions
shall be forwarded to each of NYU and CORPORATION. NYU 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, NYU or
CORPORATION, upon prior notice to and consent of the other parties,
which consent shall not unreasonably be withheld and at the cost of
the party retaining such counsel.
b. Upon prior
written approval by CORPORATION, all applications and proceedings
with respect to the UNIVERSITY Patents shall be filed, prosecuted
and maintained by SAMSF and/or NYU at the expense of CORPORATION.
Against the submission of invoices, CORPORATION shall reimburse NYU
for all costs and fees incurred by NYU during the term of this
Agreement, in connection with the filing, maintenance, prosecution
and protection and the like of the UNIVERSITY Patents.
c. NYU and
CORPORATION shall assist, and cause their respective employees and
consultants 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.
d. 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 UNIVERSITY
Patents, it shall give prompt written notice thereof to NYU, 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 subject to the rights of
SAMSF in relation thereto NYU shall, be free to grant rights in and
to such subject matter deleted from the Research Technology in such
countries to 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.
e. Nothing
herein contained shall be deemed to be a warranty by NYU
|
|
i)
|
|
that NYU can or will be able to
obtain any patent or patents on any patent application or
applications in the UNIVERSITY Patents or any portion thereof, or
that any of the UNIVERSITY Patents will afford adequate or
commercially worthwhile protection, or
|
- 4 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
|
|
ii)
|
|
that the manufacture, use, or sale
of any element of the University Research Technology or any
Licensed Product will not infringe any patent(s) of a third
party.
|
a. Subject to
the terms and conditions hereinafter set forth and subject to all
United States Government rights whether now existing or to arise
after the date hereof, NYU hereby grants to CORPORATION and
CORPORATION hereby accepts from NYU the License.
b. The
License granted to CORPORATION in Section 5.a. hereof 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 Date
of First Commercial Sale in such country or until the expiration
date of the last to expire of the UNIVERSITY Patents whichever
shall be later.
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 under a written
agreement, a copy of which shall be provided by CORPORATION to NYU
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 this 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 8 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 13 and
14 of this Agreement and shall state that NYU is an intended third
party beneficiaries of such sublicense agreement for the purpose of
enforcing such indemnification and insurance provisions.
|
a. In
consideration for the License granted herein, and during the
Payment Term, with respect to each Licensed Product, CORPORATION
shall pay to NYU a royalty of *** of
- 5 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
the Net Sales
of CORPORATION or of Corporation Entity or of a licensee or
sublicensee of CORPORATION or Corporation Entity. CORPORATION shall
inform NYU 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 NYU 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 NYU a full and detailed report of
royalties or payments due NYU 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
|
|
i)
|
|
the
quantity of Licensed Products used, sold, transferred or otherwise
disposed of;
|
|
|
|
|
|
|
|
ii)
|
|
the
selling price of each Licensed Product and Assigned
Product;
|
|
|
|
|
|
|
|
iii)
|
|
the
deductions permitted under subsection 1.g. hereof to arrive at Net
Sales; and
|
|
|
|
|
|
|
|
iv)
|
|
the
royalty computations and subject of payment.
|
If no royalties
or other payments are due, a statement shall be sent to NYU stating
such fact. Payment of the full amount of any royalties or other
payments due to NYU for the preceding half year shall be made on
even date with each Half-Year Report on royalties and 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 NYU 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 NYU with a report (hereinafter “the Annual
Report”), certified by the President or Chief Financial
Officer of CORPORATION relating to the royalties and other payments
due to NYU 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 7.b. above in respect of the
Half-Year Report.
d. On
reasonable notice and during regular business hours, NYU or the
authorized representative of NYU 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 Licensed Products, in
order to ascertain or verify the amount of royalties and other
payments due to NYU hereunder, and the accuracy of the information
provided to NYU in the aforementioned reports.
- 6 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
a. Royalties
and other payments due to NYU hereunder shall be paid to NYU in
United States dollars. Any such royalties on or other payments
relating to transactions in a foreign currency shall be converted
into United States dollars based on 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.
8.
Confidential Information
a. Except as
otherwise provided in Section 8.c. and Section 9 below,
NYU shall maintain any and all of the University 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 8.c. and 8.d. below, CORPORATION
shall maintain any and all of the University 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 NYU to said release or
disclosure.
c. The
obligations of confidentiality on NYU set forth in
Section 8.a. and b. shall not apply to any component of the
University 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 his disclosed to the receiving party by a third
party who has the right to make such disclosure.
d. The
provisions of Section 8.b. notwithstanding, CORPORATION may
disclose the UNIVERSITY Research Technology to third parties who
need to know the same in order to secure regulatory approval for
the sale of Licensed Products.
a. Prior to
submission for publication of a manuscript describing the results
of any aspect of the University Research Technology which is not
part of the public domain, NYU shall send CORPORATION a copy of the
manuscript to be submitted, and shall allow CORPORATION thirty
(30) days from the date of such mailing to determine whether
the manuscript contains such subject matter for which patent
protection should be sought prior to publication of such
manuscript, for the purpose of protecting an invention made by the
NYU Scientists. Should CORPORATION believe the subject matter of
the manuscript contains a patentable invention, then, prior to the
expiration of such 30-day period from the mailing date of such
manuscript to CORPORATION by NYU, 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 NYU has received the written
notice specified above
- 7 -
Confidential Treatment has been
requested
for portions of this document marked with asterisks.
from
CORPORATION, NYU shall be free to submit such 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, NYU 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 4. hereof of a U.S. patent
application by CORPORATION on the subject matter to be disclosed in
such grant proposal or manuscript. After expiration of such 60-day
period, or the filing of a patent application on each such
invention, whichever shall occur first, NYU shall be free to submit
the manuscript and to publish the disclosed results.
10.
Infringement of CORPORATION Patents
a. In the
event that NYU acquires information that a third party is
infringing one or more of the CORPORATION Patents, the party
acquiring such information shall promptly notify CORPORATION in
writing of such infringement.
b. NYU shall
cooperate and shall endeavor to cause the NYU Scientists to
cooperate with CORPORATION at the request of COOPERATION, 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
NYU in connection with such cooperation.
11.
Infringement of UNIVERSITY Patent
a. In the
event a party to this Agreement acquires information that a third
party is infringing one or more of the UNIVERSITY Patents, the
party acquiring such information shall promptly notify the other
party to the Agreement in writing of such infringement.
b. In the
event of an infringement of a UNIVERSITY Patent, CORPORATION shall
be entitled but not required to bring suit against the infringer.
Should CORPORATION elect to bring suit against an infringer and NYU
is joined as a party plaintiff in any such suit, NYU shall have the
right to approve the counsel selected by CORPORATION to represent
CORPORATION and NYU such approval not to be unreasonably withheld.
The expenses of such suit or suits that CORPORATION elects to
bring, including any expenses of NYU incurred in conjunction with
the prosecution of such suit or the settlement thereof, shall be
paid for entirely by CORPORATION and CORPORATION shall hold NYU
free, clear and harmless
|