PUBLIC HEALTH SERVICE PATENT LICENSE AGREEMENT – EXCLUSIVE COVER PAGE
Exhibit
10.11
PUBLIC
HEALTH SERVICE
PATENT
LICENSE AGREEMENT – EXCLUSIVE
COVER
PAGE
For PHS
internal use only:
License
Number:
License
Application Number: A-286-2006
Serial
Number(s) of Licensed Patent(s) or Patent Application(s):
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I.
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U.S.
Provisional Patent Application No. 60/771,163, filed February 6, 2006,
entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-US-01);
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II.
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U.S.
Provisional Patent Application No. 60/797,201, filed May 2, 2006, entitled
“Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/1-US-01)
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III.
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U.S.
Patent Application Serial No. 11/703,401, filed February 6, 2007, entitled
“Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-US-03)
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IV.
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PCT
International Application No. PCT/US2007/003095, filed February 6, 2007
entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-PCT-02)
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V.
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U.S.
Provisional Patent Application No. 60/963,307, filed August 3, 2007
entitled “Use of Phosphatases To Treat Neuroblastomas and
Medulloblastomas” (HHS Ref. No.
E-123-2006/2-US-01)
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VI.
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U.S.
Provisional Patent Application No. 60/063,970, filed February 6, 2008
entitled “Use of Phosphatases To Treat Neuroblastomas and
Medulloblastomas”.
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VII.
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U.S.
Application in preparation corresponding to Xxxxxx and Xxxxxx Referene No.
4101/79251.
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Licensee:
Lixte
Biotechnology, Inc.
Cooperative
Research and Development Agreement (CRADA) Number (if a subject
invention):
XXXXX Xx.
00000 (C-026-2006/0) and Four Amendments
Additional
Remarks:
N/A
Public
Benefit(s):
Novel
methods of treating glioblastomas and other tumors of the central nervous
system.
This
Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this
Cover Page, an attached Agreement, a Signature Page,
Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of
Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks and
Performance), Appendix E (Commercial Development Plan), Appendix F (Example
Royalty Report), and Appendix G (Royalty Payment Options). The
Parties to this Agreement
are:
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1)
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The
National Institutes of Health (“NIH”) or the Food and
Drug Administration (“FDA”), hereinafter
singly or collectively referred to as “PHS”, agencies of the
United States Public Health Service within the Department of Health and
Human Services (“HHS”);
and
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2)
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The
person, corporation, or institution identified above or on the Signature
Page, having offices at the address indicated on the Signature Page,
hereinafter referred to as “Licensee”.
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PHS
PATENT LICENSE AGREEMENT – EXCLUSIVE
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PHS and Licensee agree as
follows:
1.
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BACKGROUND
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1.1
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In
the course of conducting biomedical research, PHS investigators made
inventions that may have commercial
applicability.
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1.2
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By
assignment of rights from PHS employees and other
inventors, HHS, on
behalf of the Government, owns intellectual property rights claimed in any
United States or foreign patent applications or patents corresponding to
the assigned inventions. HHS also owns any
tangible embodiments of these inventions actually reduced to practice by
PHS.
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1.3
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The
Secretary of HHS
has delegated to PHS the authority to
enter into this Agreement
for the licensing of rights to these
inventions.
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1.4
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PHS desires to transfer
these inventions to the private sector through commercialization licenses
to facilitate the commercial development of products and processes for
public use and benefit.
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1.5
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Licensee
desires to acquire commercialization rights to certain of these inventions
in order to develop processes, methods, or marketable products for public
use and benefit.
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2.
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DEFINITIONS
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2.1
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“Benchmarks” mean the
performance milestones that are set forth in Appendix
D.
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2.2
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“Commercial Development
Plan” means the written commercialization plan attached as Appendix
E.
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2.3
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“First Commercial Sale”
means the initial transfer by or on behalf of Licensee or its
sublicensees of Licensed
Products or the initial practice of a Licensed Process by or
on behalf of Licensee or its
sublicensees in exchange for cash or some equivalent to which value can be
assigned for the purpose of determining Net
Sales.
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2.4
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“Government” means the
Government of the United States of
America.
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2.5
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“Licensed Fields of Use”
means the fields of use identified in Appendix
B.
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2.6
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“Licensed Patent Rights”
shall mean:
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(a)
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Patent
applications (including provisional patent applications and PCT patent
applications) or patents listed in Appendix A, all divisions and
continuations of these applications, all patents issuing from these
applications, divisions, and continuations, and any reissues,
reexaminations, and extensions of these
patents;
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(b)
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to
the extent that the following contain one or more claims directed to the
invention or inventions disclosed in
2.6(a):
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(i)
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continuations
in part of 2.6(a);
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(ii)
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all
divisions and continuations of these continuations in
part;
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(iii)
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all
patents issuing from these continuations in part, divisions, and
continuations;
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(iv)
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priority
patent application(s) of, and application(s) claiming priority of, 2.6(a);
and
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(v)
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any
reissues, reexaminations, and extensions of these
patents;
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(c)
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to
the extent that the following contain one or more claims directed to the
invention or inventions disclosed in 2.6(a): all counterpart foreign and
U.S. patent applications and patents to 2.6(a) and 2.6(b), including those
listed in Appendix A; and
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(d)
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Licensed Patent Rights
shall not include 2.6(b) or 2.6(c) to the extent that they contain one or
more claims directed to new matter which is not the subject matter
disclosed in 2.6(a).
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2.7
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“Licensed Processes”
means processes which, in the course of being practiced, would be within
the scope of one or more claims of the Licensed Patent Rights
that have not been held unpatentable, invalid or unenforceable by an
unappealed or unappealable judgment of a court of competent
jurisdiction.
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2.8
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“Licensed Products” means
tangible materials which, in the course of manufacture, use, sale, or
importation, would be within the scope of one or more claims of the Licensed Patent Rights
that have not been held unpatentable, invalid or unenforceable by an
unappealed or unappealable judgment of a court of competent
jurisdiction.
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2.9
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“Licensed Territory”
means the geographical area identified in Appendix
B.
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2.10
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“Net
Sales” means the total gross receipts for sales of Licensed Products or
practice of Licensed
Processes by or on behalf of Licensee or its
sublicensees, and from leasing, renting, or otherwise making Licensed Products
available to others without sale or other dispositions, whether invoiced
or not, less returns and allowances, packing costs, insurance costs,
freight out, taxes or excise duties imposed on the transaction (if
separately invoiced), and wholesaler and cash discounts in amounts
customary in the trade to the extent actually granted. No
deductions shall be made for commissions paid to individuals, whether they
are with independent sales agencies or regularly employed by Licensee, or
sublicensees, and on its payroll, or for the cost of
collections.
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2.11
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“Practical Application”
means to manufacture in the case of a composition or product, to practice
in the case of a process or method, or to operate in the case of a machine
or system; and in each case, under these conditions as to establish that
the invention is being utilized and that its benefits are to the extent
permitted by law or Government regulations
available to the public on reasonable
terms.
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2.12
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“Research License” means
a nontransferable, nonexclusive license to make and to use Licensed Products or
Licensed Processes
as defined by the Licensed Patent Rights
for purposes of research and not for purposes of commercial manufacture or
distribution or in lieu of
purchase.
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2.13
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"Affiliate(s)" means a
corporation or other business entity, which, directly or indirectly, is
controlled by, controls, or is under common control with Licensee. For
this purpose, the term "control" shall mean ownership of more than fifty
percent (50%) of the voting stock or other ownership interest of the
corporation or other business entity, or the power to elect or appoint
more than fifty percent (50%) of the members of the governing body of the
corporation or other business
entity.
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2
3.
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GRANT OF
RIGHTS
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3.1
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PHS hereby grants and
Licensee accepts,
subject to the terms and conditions of this Agreement, an exclusive
license under the Licensed Patent Rights
in the Licensed
Territory to make and have made, to use and have used, to sell and
have sold, to offer to sell, and to import any Licensed Products in the
Licensed Fields of Use and to practice and have practiced any Licensed Processes in
the Licensed Fields of
Use.
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3.2
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This
Agreement confers
no license or rights by implication, estoppel, or otherwise under any
patent applications or patents of PHS other than the Licensed Patent Rights
regardless of whether these patents are dominant or subordinate to the
Licensed Patent
Rights.
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4.
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SUBLICENSING
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4.1
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Upon
written approval, which shall include prior review of any sublicense
agreement by PHS
and which shall not be unreasonably withheld, Licensee may enter into
sublicensing agreements under the Licensed Patent
Rights.
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4.2
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Licensee agrees that any
sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.1
5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be
binding upon the sublicensee as if it were a party to this Agreement. Licensee further agrees
to attach copies of these Paragraphs to all sublicense
agreements.
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4.3
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Any
sublicenses granted by Licensee shall provide
for the termination of the sublicense, or the conversion to a license
directly between the sublicensees and PHS, at the option of
the sublicensee, upon termination of this Agreement under Article
13. This conversion is subject to PHS approval which will
not be unreasonably withheld and contingent upon acceptance by the
sublicensee of the remaining provisions of this Agreement.
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4.4
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Licensee agrees to
forward to PHS a
complete copy of each fully executed sublicense agreement postmarked
within thirty (30) days of the execution of the agreement. To
the extent permitted by law, PHS agrees to maintain
each sublicense agreement in
confidence.
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5.
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STATUTORY AND PHS
REQUIREMENTS AND RESERVED GOVERNMENT
RIGHTS
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5.1
(a)
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PHS reserves on behalf
of the Government
an irrevocable, nonexclusive, nontransferable, royalty free license for
the practice of all inventions licensed under the Licensed Patent Rights
throughout the world by or on behalf of the Government and on behalf
of any foreign government or international organization pursuant to any
existing or future treaty or agreement to which the Government is a
signatory. Prior to the First Commercial Sale,
Licensee agrees to
provide PHS with
reasonable quantities of Licensed Products or
materials made through the Licensed Processes for
PHS research use;
and
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(b)
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In
the event that the Licensed Patent Rights
are Subject Inventions made under a Cooperative Research and
Development Agreement (“CRADA”), Licensee grants to the
Government,
pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable,
irrevocable, paid up license to practice Licensed Patent Rights
or have Licensed Patent
Rights practiced throughout the world by or on behalf of the Government. In
the exercise of this license, the Government shall not
publicly disclose trade secrets or commercial or financial information
that is privileged or confidential within the meaning of 5 U.S.C.
§552(b)(4) or which would be considered as such if it had been obtained
from a non Federal party. Prior to the First Commercial Sale,
Licensee agrees to
provide PHS
reasonable quantities of Licensed Products or
materials made through the Licensed Processes for
PHS research
use.
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5.2
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Licensee agrees that
products used or sold in the United States embodying Licensed Products or
produced through use of Licensed Processes shall
be manufactured substantially in the United States, unless a written
waiver is obtained in advance from PHS.
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5.3
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Licensee acknowledges
that PHS may enter
into future CRADAs
under the Federal Technology Transfer Act of 1986 that relate to the
subject matter of this Agreement. Licensee agrees not to
unreasonably deny requests for a Research License from future
collaborators with PHS when acquiring these
rights is necessary in order to make a CRADA project
feasible. Licensee may request an
opportunity to join as a party to the proposed CRADA.
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5.4
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(a)
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In
addition to the reserved license of Paragraph 5.1, PHS reserves the right
to grant Research
Licenses directly or to require Licensee to grant Research Licenses on
reasonable terms. The purpose of these Research Licenses is to
encourage basic research, whether conducted at an academic or corporate
facility. In order to safeguard the Licensed Patent Rights,
however, PHS shall
consult with Licensee before granting
to commercial entities a Research License or providing to them research
samples of materials made through the Licensed Processes;
and
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(b)
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In
exceptional circumstances, and in the event that Licensed Patent Rights
are Subject Inventions made under a CRADA, the Government, pursuant to
15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a
responsible applicant a nonexclusive, partially exclusive, or exclusive
sublicense to use the Licensed Patent Rights
in the Licensed Field of
Use on terms that are reasonable under the circumstances, or if
Licensee fails to
grant this license, the Government retains the
right to grant the license itself. The exercise of these rights
by the Government
shall only be in exceptional circumstances and only if the Government
determines:
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(i)
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the
action is necessary to meet health or safety needs that are not reasonably
satisfied by Licensee;
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(ii)
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the
action is necessary to meet requirements for public use specified by
Federal regulations, and these requirements are not reasonably satisfied
by the Licensee;
or
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(iii)
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the
Licensee has
failed to comply with an agreement containing provisions described in 15
U.S.C. §3710a(c)(4)(B); and
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(c)
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The
determination made by the Government under this
Paragraph 5.4 is subject to administrative appeal and judicial review
under 35 U.S.C. §203(2).
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6.
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ROYALTIES AND
REIMBURSEMENT
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6.1
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Licensee agrees to pay
PHS a
noncreditable, nonrefundable license issue royalty as set forth in
Appendix C.
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6.2
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Licensee agrees to pay
PHS a
nonrefundable minimum annual royalty as set forth in Appendix
C.
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6.3
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Licensee agrees to pay
PHS earned
royalties as set forth in Appendix
C.
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6.4
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Licensee agrees to pay
PHS benchmark
royalties as set forth in Appendix
C.
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6.5
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Licensee agrees to pay
PHS sublicensing
royalties as set forth in Appendix
C.
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6.6
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A
patent or patent application licensed under this Agreement shall cease to
fall within the Licensed
Patent Rights for the purpose of computing earned royalty payments
in any given country on the earliest of the dates
that:
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(a)
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the
application has been abandoned and not
continued;
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(b)
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the
patent expires or irrevocably lapses,
or
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(c)
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the
claim has been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or
administrative agency.
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6.7
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No
multiple royalties shall be payable because any Licensed Products or
Licensed Processes
are covered by more than one of the Licensed Patent
Rights.
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6.8
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On
sales of Licensed
Products by Licensee to sublicensees
or on sales made in other than an arms length transaction, the value of
the Net Sales attributed under this Article 6 to this transaction shall be
that which would have been received in an arms length transaction, based
on sales of like quantity and quality products on or about the time of
this transaction.
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6.9
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PHS has not incurred any
expenses associated with the preparation, filing, prosecution, and
maintenance of the patent applications and patents included within the
Licensed Patent
Rights prior to the effective date of this
Agreement.
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6.10
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With
regard to expenses associated with the preparation, filing, prosecution,
and maintenance of all patent applications and patents included within the
Licensed Patent
Rights and incurred by PHS on or after the
effective date of this Agreement, PHS, at its sole option,
may require Licensee:
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(a)
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to
pay PHS on an
annual basis, within sixty (60) days of PHS’ submission of a
statement and request for payment, a royalty amount equivalent to these
patent expenses incurred during the previous calendar
year(s);
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(b)
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to
pay these expenses directly to the law firm employed by PHS to handle these
functions. However, in this event, PHS and not Licensee shall be the
client of the law firm; or
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(c)
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in
limited circumstances, Licensee may be given
the right to assume responsibility for the preparation, filing,
prosecution, or maintenance of any patent application or patent included
with the Licensed Patent
Rights. In that event, Licensee shall directly
pay the attorneys or agents engaged to prepare, file, prosecute, or
maintain these patent applications or patents and shall provide PHS with copies of each
invoice associated with these services as well as documentation that these
invoices have been paid.
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6.11
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PHS agrees, upon written
request, to provide Licensee with summaries
of patent prosecution invoices for which PHS has requested
payment from the Licensee under
Paragraphs 6.9 and 6.10. Licensee agrees that all
information provided by PHS related to patent
prosecution costs shall be treated as confidential commercial information
and shall not be released to a third party except as required by law or a
court of competent jurisdiction.
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6.12
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Licensee may elect to
surrender its rights in any country of the Licensed Territory under
any of the Licensed
Patent Rights upon ninety (90) days written notice to PHS and owe no payment
obligation under Paragraph 6.10 for patent-related expenses incurred in
that country after ninety (90) days of the effective date of the written
notice.
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7.
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PATENT FILING,
PROSECUTION, AND MAINTENANCE
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7.1
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Licensee shall file,
prosecute, and maintain patent application(s) relating to the Licensed Patent Rights
and shall promptly provide to PHS all serial numbers
and filing dates, together with copies of all these applications,
including copies of all Patent Office actions, responses, and all other
Patent Office communications. In addition, Licensee shall file with
Patent Offices a Power of Attorney that names both Licensee and PHS or names inventors
of the Licensed Patent
Rights who are obligated to assign to Licensee or PHS. This
Power of Attorney shall be filed with every Patent Office involved in
prosecuting all patent applications pertaining to Licensed Patent
Rights. Licensee shall consult
with PHS, when so
requested, prior to communicating with any Patent Office with respect to
the Licensed Patent
Rights. PHS shall timely provide
to Licensee or its
attorneys any formal document necessary to file, prosecute, and maintain
patents and patent applications relating to the Licensed Patent
Rights.
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7.2
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Licensee shall make an
election with respect to foreign filing, upon consultation with PHS, including which
countries foreign filing shall be done prior to the election, within eight
(8) months of any United States filing. If any foreign patent
applications are filed, Licensee shall promptly
provide to PHS all
serial numbers and filing dates. Licensee also shall
provide PHS copies
of foreign patent applications and Patent Office actions. Licensee shall consult
with PHS, when so
requested, prior to communication with any Patent Office with respect to
the Licensed Patent
Rights.
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7.3
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Licensee shall promptly
record available Assignments of domestic Licensed Patent Rights
in the United States Patent and Trademark Office and shall promptly
provide PHS with
the original of each recorded Assignment with respect to PHS.
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7.4
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Notwithstanding
any other provision of this Agreement, Licensee shall not
abandon the prosecution of any patent application, including provisional
patent applications (except for purposes of filing continuation
application(s)) or the maintenance of any patent contemplated by this
Agreement, without prior written notice to PHS. Upon
receiving the written notice, PHS may, at its sole
option, take over the prosecution of any patent application, or the
maintenance of any patent. Licensee agrees to
furnish written notice to PHS as soon as possible
after Licensee’s
decision to abandon prosecution, and Licensee will not
abandon prosecution within thirty (30) days of a prosecution deadline.
Licensee shall
promptly provide PHS with copies of all
issued patents under this
Agreement.
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7.5
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Licensee shall promptly
provide PHS with
copies of all issued patents under this
Agreement.
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7.6
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In
the event that Licensee anticipates the
possibility of any extraordinary expenditures arising from the
preparation, filing, prosecution, licensing, or defense of any patent
application or patent contemplated by this Agreement, including, without
limitation, interferences, reexaminations, reissues and oppositions, Licensee shall provide
PHS with all
relevant information.
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6
8.
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RECORD
KEEPING
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8.1
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Licensee agrees to keep
accurate and correct records of Licensed Products made,
used, sold, or imported and Licensed Processes
practiced under this Agreement appropriate to determine the amount of
royalties due PHS. These
records shall be retained for at least five (5) years following a given
reporting period and shall be available during normal business hours for
inspection, at the expense of PHS, by an accountant or
other designated auditor selected by PHS for the sole purpose
of verifying reports and royalty payments hereunder. The
accountant or auditor shall only disclose to PHS information relating
to the accuracy of reports and royalty payments made under this
Agreement. If an inspection shows an underreporting or
underpayment in excess of five percent (5%) for any twelve (12) month
period, then Licensee shall reimburse
PHS for the cost
of the inspection at the time Licensee pays the
unreported royalties, including any additional royalties as required by
Paragraph 9.8. All royalty payments required under this
Paragraph shall be due within thirty (30) days of the date PHS provides Licensee notice of the
payment due.
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8.2
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Licensee agrees to have
an audit of sales and royalties conducted by an independent auditor at
least every two (2) years if annual sales of the Licensed Products or
Licensed Processes
are over ten (10) million dollars. The audit shall address, at
a minimum, the amount of gross sales by or on behalf of Licensee during the
audit period, terms of the license as to percentage or fixed royalty to be
remitted to the Government, the amount
of royalties owed to the Government under this
Agreement, and whether the royalties owed have been paid to the Government and is
reflected in the records of the Licensee. The
audit shall also indicate the PHS license number,
product, and the time period being audited. A report certified
by the auditor shall be submitted promptly by the auditor directly to
PHS on
completion. Licensee shall pay for
the entire cost of the audit.
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9.
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REPORTS ON PROGRESS,
BENCHMARKS, SALES, AND
PAYMENTS
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9.1
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Prior
to signing this Agreement, Licensee has provided
PHS with the Commercial Development Plan
in Appendix E, under which Licensee intends to
bring the subject matter of the Licensed Patent Rights
to the point of Practical
Application. This Commercial Development Plan
is hereby incorporated by reference into this Agreement. Based
on this plan, performance Benchmarks are
determined as specified in Appendix
D.
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9.2
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Licensee shall provide
written annual reports on its product development progress or efforts to
commercialize under the Commercial Development Plan
for each of the Licensed Fields of Use
within sixty (60) days after December 31 of each calendar
year. These progress reports shall include, but not be limited
to: progress on research and development, status of applications for
regulatory approvals, manufacturing, sublicensing, marketing, importing,
and sales during the preceding calendar year, as well as, plans for the
present calendar year. PHS also encourages
these reports to include information on any of Licensee's public
service activities that relate to the Licensed Patent
Rights. If reported progress differs from that projected
in the Commercial
Development Plan and Benchmarks, Licensee shall explain
the reasons for these differences. In the annual report, Licensee may propose
amendments to the Commercial Development
Plan, acceptance of which by PHS may not be denied
unreasonably. Licensee agrees to
provide any additional information reasonably required by PHS to evaluate Licensee's performance
under this Agreement. Licensee may amend the
Benchmarks at any
time upon written approval by PHS. PHS shall not
unreasonably withhold approval of any request of Licensee to extend the
time periods of this schedule if the request is supported by a reasonable
showing by Licensee of diligence in
its performance under the Commercial Development
Plan and toward bringing the Licensed Products to the
point of Practical
Application as defined in 37 CFR §404.3(d). Licensee shall amend the
Commercial Development
Plan and Benchmarks at the
request of PHS to
address any Licensed Fields of Use not specifically addressed in the plan
originally submitted.
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9.3
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Licensee shall report to
PHS the dates for
achieving Benchmarks specified in
Appendix D and the First
Commercial Sale in each country in the Licensed Territory
within thirty (30) days of such
occurrences.
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9.4
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Licensee shall submit to
PHS, within sixty
(60) days after each calendar half year ending June 30 and December 31, a
royalty report, as described in the example in Appendix F, setting forth
for the preceding half year period the amount of the Licensed Products sold
or Licensed
Processes practiced by or on behalf of Licensee in each country
within the Licensed
Territory, the Net
Sales, and the amount of royalty accordingly due. With
each royalty report, Licensee shall submit
payment of earned royalties due. If no earned royalties are due
to PHS for any
reporting period, the written report shall so state. The
royalty report shall be certified as correct by an authorized officer of
Licensee and shall
include a detailed listing of all deductions made under Paragraph 2.10 to
determine Net
Sales made under Article 6 to determine royalties
due.
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9.5
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Licensee agrees to
forward semi annually to PHS a copy of these
reports received by Licensee from its
sublicensees during the preceding half year period as shall be pertinent
to a royalty accounting to PHS by Licensee for activities
under the sublicense.
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9.6
|
Royalties
due under Article 6 shall be paid in U.S. dollars and payment options are
listed in Appendix G. For conversion of foreign currency to
U.S. dollars, the conversion rate shall be the New York foreign exchange
rate quoted in The Wall
Street Journal on the day that the payment is due. Any
loss of exchange, value, taxes, or other expenses incurred in the transfer
or conversion to U.S. dollars shall be paid entirely by Licensee. The
royalty report required by Paragraph 9.4 shall be mailed to PHS at its address for
Agreement Notices indicated on the Signature
Page.
|
|
9.7
|
Licensee shall be solely
responsible for determining if any tax on royalty income is owed outside
the United States and shall pay the tax and be responsible for all filings
with appropriate agencies of foreign
governments.
|
|
9.8
|
Additional
royalties may be assessed by PHS on any payment that
is more than ninety (90) days overdue at the rate of one percent (1%) per
month. This one percent (1%) per month rate may be applied
retroactively from the original due date until the date of receipt by
PHS of the overdue
payment and additional royalties. The payment of any additional
royalties shall not prevent PHS from exercising any
other rights it may have as a consequence of the lateness of any
payment.
|
|
9.9
|
All
plans and reports required by this Article 9 and marked “confidential” by
Licensee shall, to
the extent permitted by law, be treated by PHS as commercial and
financial information obtained from a person and as privileged and
confidential, and any proposed disclosure of these records by the PHS under the Freedom of
Information Act (FOIA), 5 U.S.C. §552 shall be subject to the
predisclosure notification requirements of 45 CFR
§5.65(d).
|
8
10.
|
PERFORMANCE
|
|
10.1
|
Licensee shall use its
reasonable commercial efforts to bring the Licensed Products and
Licensed Processes
to Practical
Application. “Reasonable commercial efforts” for the
purposes of this provision shall include adherence to the Commercial Development
Plan in Appendix E and performance of the Benchmarks in Appendix
D. The efforts of a sublicensee shall be considered the efforts
of Licensee.
|
|
10.2
|
Upon
the First Commercial
Sale, until the expiration or termination of this Agreement, Licensee shall use its
reasonable commercial efforts to make Licensed Products and
Licensed Processes
reasonably accessible to the United States
public.
|
|
10.3
|
Licensee agrees, after
its First Commercial
Sale, to make reasonable quantities of Licensed Products or
materials produced through the use of Licensed Processes
available on a compassionate use basis to patients, either through the
patient’s physician(s) or the medical center treating the
patient.
|
|
10.4
|
Licensee agrees, after
its First Commercial
Sale and as part of its marketing and product promotion, to develop
educational materials (e.g., brochures, website, etc.) directed to
patients and physicians detailing the Licensed Products or
medical aspects of the prophylactic and therapeutic uses of the Licensed
Products.
|
|
10.5
|
Licensee agrees to
supply, to the Mailing Address for Agreement Notices indicated on the
Signature Page, the Office of Technology Transfer, NIH with inert samples
of the Licensed
Products or Licensed Processes or
their packaging for educational and display purposes
only.
|
11.
|
INFRINGEMENT AND
PATENT ENFORCEMENT
|
|
11.1
|
PHS and Licensee agree to notify
each other promptly of each infringement or possible infringement of the
Licensed Patent
Rights, as well as, any facts which may affect the validity, scope,
or enforceability of the Licensed Patent Rights
of which either party becomes
aware.
|
|
11.2
|
Pursuant
to this Agreement and the provisions of Chapter 29 of Title 35, United
States Code, Licensee
may:
|
|
(a)
|
bring
suit in its own name, at its own expense, and on its own behalf for
infringement of presumably valid claims in the Licensed Patent
Rights;
|
|
(b)
|
in
any suit, enjoin infringement and collect for its use, damages, profits,
and awards of whatever nature recoverable for the infringement;
or
|
|
(c)
|
settle
any claim or suit for infringement of the Licensed Patent Rights
provided, however, that PHS and appropriate
Government
authorities shall have the first right to take such actions;
and
|
9
|
(d)
|
If
Licensee desires
to initiate a suit for patent infringement, Licensee shall notify
PHS in
writing. If PHS does not notify
Licensee of its
intent to pursue legal action within ninety (90) days, Licensee shall be free
to initiate suit. PHS shall have a
continuing right to intervene in the suit. Licensee shall take no
action to compel the Government either to
initiate or to join in any suit for patent infringement. Licensee may request the
Government to
initiate or join in any suit if necessary to avoid dismissal of the suit.
Should the Government be made a
party to any suit, Licensee shall reimburse
the Government for
any costs, expenses, or fees which the Government incurs as a
result of the motion or other action, including all costs incurred by the
Government in
opposing the motion or other action. In all cases, Licensee agrees to keep
PHS reasonably
apprised of the status and progress of any litigation. Before
Licensee commences
an infringement action, Licensee shall notify
PHS and give
careful consideration to the views of PHS and to any potential
effects of the litigation on the public health in deciding whether to
bring suit.
|
|
11.3
|
In
the event that a declaratory judgment action alleging invalidity or non
infringement of any of the Licensed Patent Rights
shall be brought against Licensee or raised by
way of counterclaim or affirmative defense in an infringement suit brought
by Licensee under
Paragraph 11.2, pursuant to this Agreement and the provisions of Chapter
29 of Xxxxx 00, Xxxxxx Xxxxxx Code or other statutes, Licensee
may:
|
|
(a)
|
defend
the suit in its own name, at its own expense, and on its own behalf for
presumably valid claims in the Licensed Patent
Rights;
|
|
(b)
|
in
any suit, ultimately to enjoin infringement and to collect for its use,
damages, profits, and awards of whatever nature recoverable for the
infringement; and
|
|
(c)
|
settle
any claim or suit for declaratory judgment involving the Licensed Patent
Rights-provided, however, that PHS and appropriate
Government
authorities shall have the first right to take these actions and shall
have a continuing right to intervene in the suit;
and
|
|
(d)
|
If
PHS does not
notify Licensee of
its intent to respond to the legal action within a reasonable time, Licensee shall be free
to do so. Licensee shall take no
action to compel the Government either to
initiate or to join in any declaratory judgment action. Licensee may request the
Government to
initiate or to join any suit if necessary to avoid dismissal of the
suit. Should the Government be made a
party to any suit by motion or any other action of Licensee, Licensee shall reimburse
the Government for
any costs, expenses, or fees, which the Government incurs as a
result of the motion or other action. If Licensee elects not to
defend against the declaratory judgment action, PHS, at its option, may
do so at its own expense. In all cases, Licensee agrees to keep
PHS reasonably
apprised of the status and progress of any litigation. Before
Licensee commences
an infringement action, Licensee shall notify
PHS and give
careful consideration to the views of PHS and to any potential
effects of the litigation on the public health in deciding whether to
bring suit.
|
|
11.4
|
In
any action under Paragraphs 11.2 or 11.3 the expenses including costs,
fees, attorney fees, and disbursements, shall be paid by Licensee. The
value of any recovery made by Licensee through court
judgment or settlement shall be treated as Net Sales and subject to
earned royalties.
|
|
11.5
|
PHS shall cooperate
fully with Licensee in connection
with any action under Paragraphs 11.2 or 11.3. PHS agrees promptly to
provide access to all necessary documents and to render reasonable
assistance in response to a request by Licensee.
|
12.
|
NEGATION OF WARRANTIES
AND INDEMNIFICATION
|
|
12.1
|
PHS offers no warranties
other than those specified in Article
1.
|
10
|
12.2
|
PHS does not warrant the
validity of the Licensed
Patent Rights and makes no representations whatsoever with regard
to the scope of the Licensed Patent Rights,
or that the Licensed
Patent Rights may be exploited without infringing other patents or
other intellectual property rights of third
parties.
|
|
12.3
|
PHS MAKES NO WARRANTIES,
EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT
RIGHTS OR TANGIBLE MATERIALS RELATED
THERETO.
|
|
12.4
|
PHS does not represent
that it shall commence legal actions against third parties infringing the
Licensed Patent
Rights.
|
|
12.5
|
Licensee shall indemnify
and hold PHS, its
employees, students, fellows, agents, and consultants harmless from and
against all liability, demands, damages, expenses, and losses, including
but not limited to death, personal injury, illness, or property damage in
connection with or arising out of:
|
|
(a)
|
the
use by or on behalf of Licensee, its
sublicensees, directors, employees, or third parties of any Licensed Patent Rights;
or
|
|
(b)
|
the
design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or
materials by Licensee, or other
products or processes developed in connection with or arising out of the
Licensed Patent
Rights.
|
|
12.6
|
Licensee agrees to
maintain a liability insurance program consistent with sound business
practice.
|
13.
|
TERM, TERMINATION, AND
MODIFICATION OF RIGHTS
|
|
13.1
|
This
Agreement is effective when signed by all parties, unless the provisions
of Paragraph 14.16 are not fulfilled, and shall extend to the expiration
of the last to expire of the Licensed Patent Rights
unless sooner terminated as provided in this Article
13.
|
|
13.2
|
In
the event that Licensee is in default
in the performance of any material obligations under this Agreement,
including but not limited to the obligations listed in Paragraph 13.5, and
if the default has not been remedied within ninety (90) days after the
date of notice in writing of the default, PHS may terminate this
Agreement by written notice and pursue outstanding royalties owed through
procedures provided by the Federal Debt Collection
Act.
|
|
13.3
|
In
the event that Licensee becomes
insolvent, files a petition in bankruptcy, has such a petition filed
against it, determines to file a petition in bankruptcy, or receives
notice of a third party's intention to file an involuntary petition in
bankruptcy, Licensee shall
immediately notify PHS in
writing. Furthermore, PHS shall have the right
to terminate this Agreement immediately upon Licensee's receipt of
written notice.
|
|
13.4
|
Licensee shall have a
unilateral right to terminate this Agreement or any licenses in any
country or territory by giving PHS sixty (60) days
written notice to that effect.
|
|
13.5
|
PHS shall specifically
have the right to terminate or modify, at its option, this Agreement,
subject to paragraph 13.2, if PHS determines that the
Licensee:
|
11
|
(a)
|
is
not executing the Commercial Development
Plan submitted with its request for a license and the Licensee cannot
otherwise demonstrate to PHS’ reasonable
satisfaction that the Licensee has taken, or
can be expected to take within a reasonable time, effective steps to
achieve Practical
Application of the Licensed Products or
Licensed
Processes;
|
|
(b)
|
has
not achieved the Benchmarks as may be
modified under Paragraph 9.2;
|
|
(c)
|
has
willfully made a false statement of, or willfully omitted a material fact
in the license application or in any report required by the license
Agreement;
|
|
(d)
|
has
committed a material breach of a covenant or agreement contained in this
Agreement;
|
|
(e)
|
is
not keeping Licensed
Products or Licensed Processes
reasonably available to the public after commercial use
commences;
|
|
(f)
|
cannot
reasonably satisfy unmet health and safety needs;
or
|
|
(g)
|
cannot
reasonably justify a failure to comply with the domestic production
requirement of Paragraph 5.2 unless
waived.
|
|
13.6
|
In
making the determination referenced in Paragraph 13.5, PHS shall take into
account the normal course of such commercial development programs
conducted with sound and reasonable business practices and judgment and
the annual reports submitted by Licensee under Paragraph
9.2. Prior to invoking termination or modification of this
Agreement under Paragraph 13.5, PHS shall give written
notice to Licensee
providing Licensee
specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the
items referenced in 13.5(a)-13.5(g). If Licensee fails to
alleviate PHS’
concerns as to the items referenced in 13.5(a)-13.5(g) or fails to
initiate corrective action to PHS’ reasonable
satisfaction, PHS
may terminate this Agreement.
|
|
13.7
|
When
the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60)
day opportunity to respond, PHS shall have the right
to require Licensee to grant
sublicenses to responsible applicants, on reasonable terms, in any
Licensed Fields of Use under the Licensed Patent Rights,
unless Licensee
can reasonably demonstrate that the granting of the sublicense would not
materially increase the availability to the public of the subject matter
of the Licensed Patent
Rights. PHS shall not require
the granting of a sublicense unless the responsible applicant has first
negotiated in good faith with Licensee.
|
|
13.8
|
PHS reserves the right
according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if
it is determined that this action is necessary to meet the requirements
for public use specified by federal regulations issued after the date of
the license and these requirements are not reasonably satisfied by Licensee.
|
|
13.9
|
Within
thirty (30) days of receipt of written notice of PHS' unilateral decision
to modify or terminate this Agreement, Licensee may, consistent
with the provisions of 37 CFR §404.11, appeal the decision by written
submission to the designated PHS
official. The decision of the designated PHS official shall be
the final agency decision. Licensee may thereafter
exercise any and all administrative or judicial remedies that may be
available.
|
12
|
13.10
|
Within
ninety (90) days of expiration or termination of this Agreement under this
Article 13, a final report shall be submitted by Licensee. Any
royalty payments, including those incurred but not yet paid (such as the
full minimum annual royalty), and those related to patent expense, due to
PHS shall become
immediately due and payable upon termination or expiration. If
terminated under this Article 13, sublicensees may elect to convert their
sublicenses to direct licenses with PHS pursuant to
Paragraph 4.3. Unless otherwise specifically provided for under
this Agreement, upon termination or expiration of this Agreement, Licensee shall return
all Licensed
Products or other materials included within the Licensed Patent Rights
to PHS or provide
PHS with
certification of the destruction
thereof.
|
14.
|
GENERAL
PROVISIONS
|
|
14.1
|
Neither
party may waive or release any of its rights or interests in this
Agreement except in writing. The failure of the Government to assert a
right hereunder or to insist upon compliance with any term or condition of
this Agreement shall not constitute a waiver of that right by the Government or excuse a
similar subsequent failure to perform any of these terms or conditions by
Licensee.
|
|
14.2
|
This
Agreement constitutes the entire agreement between the parties relating to
the subject matter of the Licensed Patent Rights,
Licensed Products
and Licensed
Processes, and all prior negotiations, representations, agreements,
and understandings are merged into, extinguished by, and completely
expressed by this Agreement.
|
|
14.3
|
The
provisions of this Agreement are severable, and in the event that any
provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of law, this determination shall
not in any way affect the validity or enforceability of the remaining
provisions of this Agreement.
|
|
14.4
|
If
either party desires a modification to this Agreement, the parties shall,
upon reasonable notice of the proposed modification by the party desiring
the change, confer in good faith to determine the desirability of the
modification. No modification shall be effective until a
written amendment is signed by the signatories to this Agreement or their
designees.
|
|
14.5
|
The
construction, validity, performance, and effect of this Agreement shall be
governed by Federal law as applied by the Federal courts in the District
of Columbia.
|
|
14.6
|
All
Agreement notices required or permitted by this Agreement shall be given
by prepaid, first class, registered or certified mail or by an
express/overnight delivery service provided by a commercial carrier,
properly addressed to the other party at the address designated on the
following Signature Page, or to another address as may be designated in
writing by the other party. Agreement notices shall be considered timely
if the notices are received on or before the established deadline date or
sent on or before the deadline date as verifiable by U.S. Postal Service
postmark or dated receipt from a commercial carrier. Parties
should request a legibly dated U.S. Postal Service postmark or obtain a
dated receipt from a commercial carrier or the U.S. Postal
Service. Private metered postmarks shall not be acceptable as
proof of timely mailing.
|
|
14.7
|
This
Agreement may not be assigned without prior written permission from PHS except to an
Affiliate, which permission shall not be unreasonably
withheld. Licensee shall provide
PHS a minimum of
sixty (60) days to grant the written permission. In the event
that no response from PHS during the sixty
(60) day period is received, Licensee shall consider
the permission granted. Licensee shall pay PHS, as an additional
royalty, one percent (1%) of the fair market value of any consideration
received for any assignment of this Agreement within thirty (30) days of
the assignment.
|
13
|
14.8
|
Licensee agrees in its
use of any PHS
supplied materials to comply with all applicable statutes, regulations,
and guidelines, including PHS and HHS regulations and
guidelines. Licensee agrees not to
use the materials for research involving human subjects or clinical trials
in the United States without complying with 21 CFR Part 50 and 45 CFR Part
46. Licensee agrees not to
use the materials for research involving human subjects or clinical trials
outside of the United States without notifying PHS, in writing, of the
research or trials and complying with the applicable regulations of the
appropriate national control authorities. Written notification
to PHS of research
involving human subjects or clinical trials outside of the United States
shall be given no later than sixty (60) days prior to commencement of the
research or trials.
|
|
14.9
|
Licensee acknowledges
that it is subject to and agrees to abide by the United States laws and
regulations (including the Export Administration Act of 1979 and Arms
Export Control Act) controlling the export of technical data, computer
software, laboratory prototypes, biological material, and other
commodities. The transfer of these items may require a license
from the appropriate agency of the U.S. Government or written
assurances by Licensee that it shall
not export these items to certain foreign countries without prior approval
of this agency. PHS neither represents
that a license is or is not required or that, if required, it shall be
issued.
|
|
14.10
|
Licensee agrees to xxxx
the Licensed
Products or their packaging sold in the United States with all
applicable U.S. patent numbers and similarly to indicate “Patent Pending”
status. All Licensed Products
manufactured in, shipped to, or sold in other countries shall be marked in
a manner to preserve PHS patent rights in
those countries.
|
|
14.11
|
By
entering into this Agreement, PHS does not directly or
indirectly endorse any product or service provided, or to be provided, by
Licensee whether
directly or indirectly related to this Agreement. Licensee shall not state
or imply that this Agreement is an endorsement by the Government, PHS, any other Government
organizational unit, or any Government
employee. Additionally, Licensee shall not use
the names of NIH,
FDA, PHS, or HHS or the Government or their
employees in any advertising, promotional, or sales literature without the
prior written approval of PHS.
|
|
14.12
|
The
parties agree to attempt to settle amicably any controversy or claim
arising under this Agreement or a breach of this Agreement, except for
appeals of modifications or termination decisions provided for in Article
13. Licensee agrees first to
appeal any unsettled claims or controversies to the designated PHS official, or
designee, whose decision shall be considered the final agency
decision. Thereafter, Licensee may exercise
any administrative or judicial remedies that may be
available.
|
|
14.13
|
Nothing
relating to the grant of a license, nor the grant itself, shall be
construed to confer upon any person any immunity from or defenses under
the antitrust laws or from a charge of patent misuse, and the acquisition
and use of rights pursuant to 37 CFR Part 404 shall not be immunized from
the operation of state or Federal law by reason of the source of the
grant.
|
|
14.14
|
Any
formal recordation of this Agreement required by the laws of any Licensed Territory as a
prerequisite to enforceability of the Agreement in the courts of any
foreign jurisdiction or for other reasons will be carried out by Licensee at its expense,
and appropriately verified proof of recordation will be promptly furnished
to PHS.
|
|
14.15
|
Paragraphs
4.3, 8.1, 9.5-9.7, 12.1-12.5, 13.9, 13.10, and 14.13 of this Agreement
shall survive termination of this
Agreement.
|
14
|
14.16
|
The
terms and conditions of this Agreement shall, at PHS’ sole option, be
considered by PHS
to be withdrawn from Licensee’s consideration
and the terms and conditions of this Agreement, and the Agreement itself
to be null and void, unless this Agreement is executed by the Licensee and a fully
executed original is received by PHS within sixty (60)
days from the date of PHS signature found at
the Signature Page.
|
SIGNATURES
BEGIN ON NEXT PAGE
15
PHS
PATENT LICENSE AGREEMENT – EXCLUSIVE
SIGNATURE
PAGE
For
PHS:
|
|||
|
|
||
Xxxxxxx
X. Xxxxxxxxx.
M.B.A. Date
|
Date
|
||
Director,
Division of Technology Development and Transfer
|
|||
Office
of Technology Transfer
|
|||
National
Institutes of Health
|
|||
Mailing
Address for Agreement
notices:
|
|||
Chief,
Monitoring & Enforcement Branch, DTDT
|
|||
Office
of Technology Transfer
|
|||
National
Institutes of Health
|
|||
0000
Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
|
|||
Xxxxxxxxx,
Xxxxxxxx 00000-0000 X.X.X.
|
|||
For
Licensee (Upon,
information and belief, the undersigned expressly certifies or affirms
that the contents of any statements of Licensee made or
referred to in this document are truthful and accurate.):
|
|||
by:
|
|||
|
|||
Signature
of Authorized Official
|
Date
|
||
|
|||
|
|||
Xxxx
X. Xxxxxx
|
|||
Printed
Name
|
|||
|
|||
Chief
Executive Officer
|
|||
Title
|
16
I.
Official and Mailing Address for Agreement
notices:
|
|
Xxxx X.
Xxxxxx
|
|
Name
|
|
Chief
Executive
Officer
|
|
Title
|
|
Mailing
Address
|
|
Lixte
Biotechnology, Inc.
|
|
000
Xxxxx 00X #0
|
|
Xxxx
Xxxxxxxx, XX 00000
|
|
Email
Address:
|
|
Phone: 000-000-0000
|
|
Fax: 000-000-0000
|
|
II. Official
and Mailing Address for Financial notices (Licensee’s contact
person for royalty payments)
|
|
Xxxx X.
Xxxxxx
|
|
Name
|
|
Chief
Executive
Officer
|
|
Title
|
|
Mailing
Address:
|
|
Lixte
Biotechnology, Inc.
|
|
000
Xxxxx 00X #0
|
|
Xxxx
Xxxxxxxx, XX 00000
|
|
Email
Address:
|
|
Phone:
000-000-0000
|
|
Fax: 000-000-0000
|
|
Any
false or misleading statements made, presented, or submitted to the Government, including
any relevant omissions, under this Agreement and during the
course of negotiation of this Agreement are subject to
all applicable civil and criminal statutes including Federal statutes 31
U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal
liability including fine(s) or
imprisonment).
|
17
APPENDIX
A – PATENT(S) OR PATENT APPLICATION(S)
Patent(s)
or Patent Application(s):
I.
|
U.S.
Provisional Patent Application No. 60/771,163, filed February 6, 2006,
entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-US-01);
|
II.
|
U.S.
Provisional Patent Application No. 60/797,201, filed May 2, 2006, entitled
“Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/1-US-01)
|
III.
|
U.S.
Patent Application Serial No. 11/703,401, filed February 6, 2007, entitled
“Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-US-03)
|
IV.
|
PCT
International Application No. PCT/US2007/003095, filed February 6, 2007
entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
E-123-2006/0-PCT-02)
|
V.
|
U.S.
Provisional Patent Application No. 60/963,307, filed August 3, 2007
entitled “Use of Phosphatases To Treat Neuroblastomas and
Medulloblastomas” (HHS Ref. No.
E-123-2006/2-US-01)
|
VI.
|
U.S.
Provisional Patent Application No. 60/063,970, filed February 6, 2008
entitled “Use of Phosphatases To Treat Neuroblastomas and
Medulloblastomas”.
|
VII.
|
U.S.
Application in preparation corresponding to Xxxxxx and Xxxxxx Referene No.
4101/79251.
|
APPENDIX
B – LICENSED FIELDS OF USE AND TERRITORY
I.
|
Licensed Fields of
Use:
|
|
(a)
|
Treatment
of Glioblastomas and other Central Nervous System (CNS)
tumors
|
II.
|
Licensed
Territory:
|
|
(a)
|
Worldwide
|
APPENDIX C –
ROYALTIES
Royalties:
I.
|
Licensee agrees to pay
to PHS a
noncreditable, nonrefundable license issue royalty in the amount of Twenty
Five Thousand dollars ($25,000) within sixty (60) days from the effective
date of this Agreement.
|
II.
|
Licensee agrees to pay
PHS a
nonrefundable minimum annual royalty in the amount of Thirty Thousand
($30,000) on January 1 of each calendar year following the year during
which the March 22, 2006 CRADA agreement, as appended, between the parties
is terminated and may be credited against any earned royalties due for
sales made in that year.
|
III.
|
Licensee agrees to pay
PHS earned
royalties of Four and one-half percent (4.5%) on Net Sales by or on
behalf of Licensee
and its sublicensees.
|
IV.
|
Licensee agrees to pay
PHS Benchmark royalties
within thirty (30) days of achieving each Benchmark:
|
|
(a)
|
Fifty
Thousand dollars ($50,000) upon starting Phase I Clinical
Trials;
|
|
(b)
|
One
Hundred Thousand dollars ($100,000) upon starting Phase II Clinical
Trials;
|
|
(c)
|
Two
Hundred Thousand dollars ($200,000) upon starting Phase III Clinical
Trials;
|
|
(d)
|
Three
Hundred Thousand dollars ($300,000) upon filing an IND submission;
and
|
|
(e)
|
Six
Hundred Twenty Five Thousand dollars ($625,000) upon the First Commercial
Sale
|
V.
|
Licensee agrees to pay
PHS additional
sublicensing royalties of fifteen percent (15%) on the fair market value
of any consideration received for granting each sublicense within sixty
(60) days of the execution of each
sublicense.
|
APPENDIX
D – BENCHMARKS AND PERFORMANCE
Licensee agrees to the
following Benchmarks for
its performance under this Agreement and, within thirty
(30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been
achieved.
I.
|
Initiation
of Phase I Clinical Trials – Est. Second Quarter,
2010
|
II.
|
Initiation
of Phase II Clinical Trials – Est. Second Quarter,
2011
|
III.
|
Initiation
of Phase III Clinical Trials – Est. Third Quarter,
2012
|
IV.
|
Filing
of an IND Submission – Est. Fourth Quarter,
2009
|
V.
|
First
Commercial Sale Expected Timeline – Est. First Quarter,
0000
|
XXXXXXXX X – COMMERCIAL
DEVELOPMENT PLAN
The
ultimate objective of the CRADA is to identify, characterize, and bring to
clinical trial regimens for the treatment of human brain tumors (GBMs) and other
Central Nervous System (CNS) tumors. Lixte Biotechnology Holdings,
Inc., the parent company of Licensee will most likely
conduct such a clinical trial in association with NINDS.
Licensee is in contact with
several large pharmaceutical companies with major programs in development and
evaluation of anti-cancer drugs about co-developing one or more phosphatase
ligands shown to have anti-cancer activity in vitro and in vivo in the CRADA
studies. Licensee, however, is prepared
to work with NINDS and /or other branches of NIH to develop these compounds
through pre-clinical evaluation and clinical testing without the addition of a
larger pharmaceutical partner.
To
facilitate this approach, NINDS has submitted an application to the NIH RAID
PILOT program to be reviewed in the summer of 2008. If approved,
NINDS would collaborate with Licensee to complete
pre-clinical development of one lead compound under the RAID program through to
submission of an IND to the FDA for a Phase I trial. The Phase I
trial could be done with one of several large academic brain tumor centers in
the US, including the surgical neurology branch of NINDS. Following
completion of Phase I testing, Licensee is committed to
supporting Phase II evaluations with or without an additional partner from the
pharmaceutical industry.
APPENDIX
F – EXAMPLE ROYALTY REPORT
Required
royalty report information includes:
|
·
|
XXX
license reference number
(L-XXX-200X/0)
|
|
·
|
Reporting
period
|
|
·
|
Catalog
number and units sold of each Licensed Product (domestic and
foreign)
|
|
·
|
Gross
Sales per catalog number per
country
|
|
·
|
Total
Gross Sales
|
|
·
|
Itemized
deductions from Gross Sales
|
|
·
|
Total
Net Sales
|
|
·
|
Earned
Royalty Rate and associated
calculations
|
|
·
|
Gross
Earned Royalty
|
|
·
|
Adjustments
for Minimum Annual Royalty (MAR) and other creditable payments
made
|
|
·
|
Net
Earned Royalty due
|
Example
Catalog Number
|
Product Name
|
Country
|
Units Sold
|
Gross Sales (US$)
|
|||||||||
1
|
A
|
US
|
250 | 62,500 | |||||||||
1
|
A
|
UK
|
32 | 16,500 | |||||||||
1
|
A
|
France
|
25 | 15,625 | |||||||||
2
|
B
|
US
|
0 | 0 | |||||||||
3
|
C
|
US
|
57 | 57,125 | |||||||||
4
|
D
|
US
|
12 | 1,500 | |||||||||
Total
Gross Sales
|
153,250 | ||||||||||||
Less
Deductions:
|
|||||||||||||
Freight
|
3,000 | ||||||||||||
Returns
|
7,000 | ||||||||||||
Total
Net Sales
|
143,250 | ||||||||||||
Royalty
Rate
|
8 | % | |||||||||||
Royalty
Due
|
11,460 | ||||||||||||
Less
Creditable Payments
|
10,000 | ||||||||||||
Net
Royalty Due
|
1,460 |
APPENDIX
G – ROYALTY PAYMENT OPTIONS
NIH/PHS License
Agreements
*In order to process payment
via Electronic Funds Transfer sender MUST supply the following
information:
Procedure
for Transfer of Electronic Funds to NIH for Royalty Payments
Bank
Name: Federal Reserve Bank
ABA#
000000000
TREAS
NYC
BNF=/AC-75080031
OBI=Licensee
Name and XXX Reference Number
Dollar
Amount Wired=$$
NOTE: Only
U.S. banks can wire directly to the Federal Reserve Bank. Foreign banks cannot
wire directly to the Federal Reserve Bank, but must go through an intermediary
U.S. bank. Foreign banks may send the wire transfer to the U.S. bank of their
choice, who, in turn forwards the wire transfer to the Federal Reserve
Bank.
Checks
drawn on a U.S. bank account should be sent directly to the following
address:
National
Institutes of Health (NIH)
X.X. Xxx
000000
Xx.
Xxxxx, XX 00000-0000
Overnight
or courier deliveries should be sent to the following address:
US
Bank
Government
Lockbox SL-MO-C2GL
0000
Xxxxxxxxxx Xxxxx
Xx.
Xxxxx, XX 00000
Phone:
000-000-0000
Checks
drawn on a foreign bank account should be sent directly to the following
address:
National
Institutes of Health (NIH)
Office of
Technology Transfer
Royalties
Administration Unit
6011
Executive Boulevard
Suite
325, MSC 7660
Xxxxxxxxx,
Xxxxxxxx 00000
Phone:
000-000-0000
All
checks should be made payable to “NIH Patent Licensing”.
The XXX Reference Number
MUST appear on checks, reports and correspondence