EXHIBIT 10.20
EXECUTION COPY
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement"), is made as of this 12th
day
of June, 2006 the "Effective Date"), by and between JDA MEDICAL
TECHNOLOGIES,
INC. a Maryland corporation with offices located at 6501 Autumn
Wind Circle,
Clarksville, Maryland 21029 ("Licensor"), and FOUNTAIN
PHARMACEUTICALS, INC., a
Delaware corporation with offices located at 19022 Marksburg Court,
Germantown,
Maryland 20874 ("Licensee").
WHEREAS. Licensor is the exclusive licensee of certain Patent
Rights
(as defined herein) relating to the treatment of human
diseases;
WHEREAS. Licensor has the right to grant sublicenses under the
Patent
Rights anti desires to rant a license of such rights to
Licensee;
WHEREAS. Licensee intends to develop, manufacture, market and sell
the
Licensed Products as defined herein; and
WHEREAS. Licensee desires to obtain a license to the Patent Rights
in
accordance with the terms and conditions of this Agreement.
NOW THEREFORE in consideration of the mutual covenants and
agreements
contained herein and for other good and valuable consideration, the
receipt and
sufficiency, of which are hereby acknowledged, the parties agree as
follows:
1. Definitions. For purposes of this Agreement, the following words
and phrases
shall have he following meanings:
1.1 "First Commercial Sale" shall mean the initial transfer of
a
Licensed Product for compensation by Licensee or its Sublicenses to
any third
party. Transfer of a Licensed Product for clinical or other testing
occurring
prior to the issuance of any required regulatory approval for sale
does not
constitute a First Commercial Sale.
1.2 "Licensee Improvement" shall mean any invention, discovery,
enhancement, modification or improvement arising out of or
resulting from use of
the Patent Rights which is or may be patentable or otherwise
protected under
law, made by one or more employees or subcontractors of Licensee:
with the
exception of the Licensee Patent Rights Improvements.
1.3 "Licensee Patent Rights Improvement" shall mean any
invention.
modification or discovery, made by one or more employees or
subcontractors of
Licensee, which is directly related to the Patent Rights in the
Licensed Field,
the practice of which, if unlicensed, would infringe one or more
claims of the
Patent Rights, or which has a similar structure to the Patent
Rights and
performs a similar function to that described in the Patent Rights
in a better
or more economical manner, which is or may be patentable or
otherwise protected
under law in each ease that is (i) a composition solely comprised
of a Patent
Rights Linker. (ii) methods of using a Patent Rights Linker, or
(iii) methods of
manufacturing a Patent Rights Linker.
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1.4 "Licensed Field of Use" shall mean the human healthcare
field.
1.5 "Licensed Product" shall mean any product or part thereof
which:
(a) is covered, in whole or in part by an issued, valid,
unexpired
claim or a pending claim contained in the Patent Rights in the
country in which
such product or part thereof is made, used, leased, offered for
sale, sold or
imported:
(b) is made by a process that is covered, in whole or in part,
by
an issued, valid, unexpired claim or a pending claim contained in
the Patent
Rights in the country in which such product or pan thereof is made,
used,
leased, offered for sale sold or imported; or
(c) incorporates any Licensee Patent Rights Improvement.
1.6 "Licensed Territory" shall mean China, Hong Kong and
Taiwan.
1.7 Licensor
improvement" shall mean any invention, discovery,
enhancement or improvement arising out of or resulting from use of
the Patent
Rights which is or may be patentable or otherwise protected under
law made by
one or more employees or subcontractors of Licensor.
1.8 "Licensor Information" shall mean any and all materials,
technical
information, data, know-how and other infix-motion developed or
created prior to
the Effective Date of this Agreement and provided to Licensee by
Licensor after
the Effective Date and pertaining to the Patent Rights whether or
not it is of a
confidential nature: but specifically not including the Software:
provided
however, that such transfer shall not exceed three (3) hours of
Licensor's time
and effort.
1.9 "Net
Sales" shall mean the gross sales revenues and fees billed by
Licensee or its Sublicenses, for the sale of Licensed Products,
less the sum of
(1) amounts actually allowed or credited on returns or rejections
of Licensed
Products; (2) value added taxes or use taxes, tariffs,
import/export duties, and
other excise taxes imposed upon particular sales; and (3) shipping,
handling,
transportation and insurance charges. In computing Net Sales, (1)
no deductions
from gross revenues and fees shall be made for commissions paid to
individuals
or entities, whether they be with independent sales agencies or
regularly
employed on the payroll by Licensee or its Sublicenses, or for cost
of
collections, and (2) Licensed Products will be considered sold when
billed out
or invoiced. whichever is first.
1.10 "Patent Rights" shall mean Licensor's rights in any patents
and
patent applications and any patents issued from said applications
and any
divisionals, continuations. continuations-in-part, re-examinations,
and reissues
of said applications: and any foreign equivalents or patents
issuing thereon.
Patents and applications contained within the Patent Rights are
listed in
Exhibit A, as may be amended from time to time.
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1.11 "Patent Rights Linker" shall mean any linking carrier between
a
core of a microparticle and the therapeutic agent, that consists of
the subject
matter claimed in the Patent Rights as of the Effective Date.
1.12 "Software" shall mean any and all software and related
documentation developed by Licensor and/or its suppliers and agents
for use in
conjunction with the Patent Rights or the Licensed Products.
1.13 "Sublicensee" shall mean any person or entity to which
License
sublicenses any or all of the rights granted to Licensee under the
terms and
conditions of this Agreement.
1.14 "University of Maryland Agreement" shall mean that
agreement
between Licensor and the University of Maryland, Baltimore, dated
as of
September 16, 2003, under which the Patent Rights are licensed to
Licensor.
2. License Grant.
2.1 Subject to certain rights which may be held by the United
States
Government and certain rights reserved by the University of
Maryland, Baltimore
with respect to research, leaching and non-commercial purposes,
during the Term
of this Agreement. Licensor hereby grants to Licensee an
exclusive,
non-transferable, sublicensable (in accordance with Section 12
herein) right and
license, solely in the Licensed Territory and the Licensed Field of
Use, (i)
under the Patent Rights and the Licensee Patent Rights improvements
to make,
have made, sell, lease, offer for sale, and import the Licensed
Products, and
(ii) to use the Licensor Information solely in connection with the
Licensed
Products.
2.2 During the Term of this Agreement and subject to the terms
and
conditions of this Agreement, Licensee may sublicense the rights
granted
hereunder to its Sublicensees consistent with, and at least as
restrictive as,
the terms and conditions of this Agreement.
2.2.1 Licensee agrees that any sublicenses granted by Licensee
shall contain such provisions as are necessary for Licensee to meet
its
obligations under this Agreement and to reasonably protect the
interests of
Licensor with regard to such sublicense.
2.2.2 Within fourteen (14) days following execution, Licensee
agrees to forward to Licensor a copy of any and all fully executed
sublicense
agreements executed hereunder, provided that such agreements may be
redacted
with respect to terms and conditions not applicable to the subject
matter of
this Agreement. Licensee shall also deliver a copy of all
applicable reports
received by Licensee from Sublicensees under the sublicenses as
shall be
pertinent to a royalty accounting under such sublicense agreements:
provided
that such copies may be redacted with respect to terms and
conditions not
applicable to the subject matter of this Agreement.
2.2.3 Licensee shall not accept or receive from any Sublicense
anything of value in lieu of cash in consideration for any
sublicense or other
transfer of Patent Rights or Licensed Products, that has any effect
on any
royalty or other payments due under this Agreement or on the
determination of
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the value of the Net Sales of the Licensee or any Sublicensee,
without
Licensor's prior written approval, which approval shall not be
unreasonably
withheld, delayed or conditioned. In any event, Licensor shall
provide such
approval, or notice of its decision not to provide such approval,
within
fourteen (14) business days following Licensee's requesting such
approval.
Licensee shall promptly give written notice to Licensor of
Licensee's acceptance
or receipt from any Sublicensee of anything of value in lieu of
cash in
consideration for any sublicense or other transfer of Patent Rights
or Licensed
Products not requiring Licensor's approval under this Section
2.2.3.
2.2.4 Upon termination of this Agreement for any reason, all
sublicenses that are granted by Licensee to a Sublicensee pursuant
to this
Agreement will remain in effect and Licensee shall cause such
Sublicensee to
agree in writing to be bound by all applicable terms and conditions
of this
Agreement, except those previously completely fulfilled by
Licensee. For
clarity, Licensor will not be bound to perform any duties or
obligations set
forth in any sublicenses that extend beyond the duties and
obligations of
Licensor set forth in this Agreement. Any sublicense granted by
Licensee shall
include provisions corresponding to those of this Section 2.2.4
with respect to
termination and the conditions of continuance of sublicenses.
2.3 The license granted hereunder shall not be construed to confer
any
rights upon Licensee by implication, estoppel, or otherwise, other
than as
specifically set forth in this Agreement. Any rights not expressly
granted under
this Agreement by Licensor to Licensee are hereby reserved by
Licensor.
3. Intellectual Property Rights.
3.1 Licensee acknowledges and agrees that Licensor shall own all
right,
title and interest in and to all Licensor Improvements. Licensee
further
acknowledges that Licensor shall own all right, title and interest
in and to any
and all Licensee Patent Rights Improvements. Accordingly, Licensee
shall assign
to Licensor all right, title and interest of Licensee to and under
any and all
intellectual property rights in any and all Licensee Patent Rights
Improvements.
Licensee shall promptly disclose the Licensee Patent Rights
Improvements to
Licensor in writing within forty-five (45) days of their
development. Licensee
agrees to execute any and all documents and other instruments and
to do all
things reasonably requested by Licensor to vest Licensor with all
right, title
and interest in and to the Licensee Patent Rights Improvements,
other than those
rights explicitly granted under this Agreement.
3.2 Licensor acknowledges and agrees that Licensee shall own all
right,
title and interest in and to any and all Licensee improvements.
Licensee shall
promptly disclose the Licensee Improvements and all related
information
necessary for Licensor's review in writing to Licensor within
forty-five (45)
days of their development. Licensor shall have the first option to
enter into a
license agreement with Licensee for such Licensee Improvement and
any and all
associated materials, technical information, data, know-how and
other
information for the purposes of selling products incorporating such
Licensee
Improvement anywhere in the world. Licensor may exercise such
option by
providing written notice to Licensee within ninety (90) days
following
licensor's receipt of Licensee's written notice of such Licensee
Improvement
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and the related materials identified above. Such license agreement
shall include
terms and conditions mutually agreeable to the parties. Licensee
shall use best
efforts to take such actions, including filing of patent
applications,
consummate with the rights granted, in order to protect licensee's
rights in the
Licensee Improvements.
3.3 Upon written notice by Licensor to Licensee, the parties agree
that
they shall negotiate in good with to grant access to Licensor to
the clinical
data developed by Licensee.
3.4 Except as expressly set forth herein. nothing in this Agreement
is
intended to grant any rights to either party under any patent or
copyright of
the other party, nor shall this Agreement grant any party any
rights in or to
the Confidential Information (as defined in Section 7) of the other
party.
4. Licensee
Responsibilities.
4.1 Licensee shall use its best efforts to bring one or more
Licensed
Products to market in the Licensed Territory through a thorough and
diligent
program for exploitation of the Patent Rights in the Licensed
Territory and
Licensed field or Use. Licensee's Rights shall satisfy the
Following milestones:
(a) Within ninety (90) days following the Effective Date,
Licensee shall deliver to Licensor a commercially reasonable
research and
development plan (the "R &D Plan"), showing the amount of money
and time
budgeted and planned the technical development of the Patent Rights
and a
proposed commercialization scheme for the Licensed Products within
the Licensed
Territory and the Licensed Field of Use.
(b) Licensee shall provide quarterly written reports at the end
of each calendar quarter during the Term to Licensor on progress
against the R&D
Plan, including without limitation, information on the research and
development
activities related to the Licensed Products and marketing analyses,
and any
commercially reasonable changes in the R&D Plan, which shall be
made at
Licensee's discretion.
(c) Licensee shall commence development of a Licensed Product
and shall employ at least three (3) full-time persons on such
development not
later than December 31, 2006. Such persons shall be reasonably
trained and
skilled in development efforts related to the Licensed Products and
the Patent
Rights.
(d) Licensee shall provide written notice to Licensor of the
categorization of its first Licensed Product by the Chinese
regulatory authority
as a medical device or a pharmaceutical within seven (7) days of
learning of
such classification.
(e) In the event that the first Licensed Produce is a medical
device. License Shall:
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(i) initiate human clinical trials of such Licensed Product
not later than June 1, 2008; and
(ii) have commercially available for sale such Licensed
Product within the Licensed Territory and the Licensed Field of Use
not later
than December 31. 2010.
(f) In the event that the first licensed Product is a
pharmaceutical. License shall:
(i) initiate human clinical trials of such Licensed Product
not later than July 1, 2010; and (ii) have commercially available
for sale such
Licensed Product within the Licensed Territory and the Licensed
Field of Else
not later than December 31. 2013.
4.2 Licensee shall ensure that "Patent Pending" or the Patent
Rights
patent number or both appears on all Licensed Products, their
labels or their
packaging to the extent necessary to secure the enforceability of
the Patent
Rights under applicable law.
4.3 Licensee's failure to satisfy the requirements of this Section
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shall be grounds for Licensor to either (i) convert Licensee's
exclusive license
grant hereunder to a non-exclusive license grant or (ii) terminate
this
Agreement in accordance with the terms of Section 14.4 herein.
Licensor may
convert the exclusive license grant to a non-exclusive license
grant, for lack
of diligence under Section 4.1 herein, upon thirty (30) days' prior
written
notice to Licensee and Licensee's failure to cure such breach
within such thirty
(30) day period.
5. Fees and
Royalties.
5.1 In consideration of the rights and license granted
hereunder.
License shall pay fees and royalties to Licensor in the manner
provided
hereunder
(a) On the Effective Date, Licensee shall pay to Licensor a
non-refundable license fee of Ten Thousand Dollars ($10,000).
(b) Licensee shall pay to Licensor an annual License
maintenance fee of Two Thousand Dollars ($2.000) which shall he due
and payable
on each anniversary of the Effective Date (the "Maintenance
Fee").
(c) Licensee shall pay the following milestone payments;
i) Upon licensee's initiation of human clinical
trials or production of human data with respect to the first
Licensed Product to reach that stage of development,
Licensee shall pay to Licensor Five Thousand Dollars
($5.000); and
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(ii) Upon the first grant of regulatory approval
with respect to the first Licensed Product to receive a
regulatory approval under this Agreement. licensee shall pay
to Licensor Fifty Thousand Dollars ($50,000).
(d) Licensee shall pay a running royalty equal to three percent
(3%) of the Net Sales of Licensed Products: provided however, that
for sales
between Licensee and its Sublicensees, the royalty for Net Sales of
Licensed
Products shall he paid only with respect to the sales of such
Sublicensee.
Commencing with the calendar year in which the First Commercial
Sale occurs, the
Maintenance Fees for such calendar year shall be credited against
the running
royalty fees for such calendar year. Such royalty payments shall be
due and
payable within sixty (60) days of the end of the calendar quarter
in which they
are incurred and shall be accompanied with the applicable report in
accordance
with the requirements of Section 6 herein. If no royalty is due for
any
quarterly period, Licensee shall so report.
(e) Royalties are payable from the country in which they are
earned and are subject to foreign exchange regulations then
prevailing in the
country. Royalty payments must be paid to Licensor in United States
Dollars in
cash or by check or wire transfer of immediately available funds.
To the extent
sales may have been made by licensee and/or its Sublicensees in a
foreign
country, those royalties will he determined first in the currency
of the country
in which the royalties are earned, and then converted to their
equivalent in
United States Dollars. The buying rates of exchange for converting
the
currencies involved into the currency of the United States quoted
by the Morgan
Guaranty Trust Company of New York, New York, averaged on the last
business day
of each of three (3) consecutive calendar months constituting the
quarterly
period in which the royalties were earned, will be used to
determine any such
conversion. Licensee will bear any loss of exchange or value or pay
any expenses
incurred in the transfer or conversion to United States
Dollars.
(f) To the extent that statutes, laws, codes, or government
regulations (including currency exchange regulations) prevent or
limit royalty
payments to Licensor by Licensee or its Sublicensces with respect
to Net Sales
received in any country, Licensee shall render to Licensor
quarterly reports of
Net Sales of Licensed Products in such country. All monies due and
owing to
Licensor as provided in such quarterly reports at Licensors option
(1) shall be
deposited promptly by Licensee or its Sublicensees, as the case may
be in a
local bank in such country in an account to be designated by
Licensor in
writing, or (2) will he paid promptly to Licensor or deposited in
its account,
as directed in writing by Licensor in any other country where the
payment or
deposit is lawful under the currency restrictions. For clarity,
"promptly" as
used in this subsection 5.1(f) shall mean in accordance with the
timing set
forth in Section 5.1(d).
(g) In the event of stacking royalties where licensee
determines that it is necessary to pay additional royalties to
other parties or
Licensor in order to produce a Licensed Product, and the sum of
royalties to be
paid by Licensee to all parties would exceed ten percent (10%) of
Net Sales,
Licensee may deduct such amount owing to such third parties (prior
to any
reductions) from the royalty owing to Licensor for the sale of such
License
Products pursuant to Section 5.1(d) above. Notwithstanding the
foregoing
provisions of this Section 5.1(g), in no event shall the royalties
due to
Licensor pursuant to Section 5.1(d) above be so reduced to less
than fifty
percent (50%) of the amount that would otherwise he due Licensor
thereunder.
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(h) All amounts not paid when due shall accrue interest daily
at the lesser of a monthly rate of one and one-half percent (1.5%)
or the
highest rate permissible by law on the unpaid balance as calculated
from the
date such amount is due until paid in full
6. Reports and Records.
6.1 Licensee shall keep, and shall cause its Sublicensees to
keep,
full, true and accurate books of account containing all particulars
that may be
necessary for the purpose of showing the amounts payable to
Licensor hereunder,
and said books and the supporting data shall be open, to the extent
allowable by
applicable law, during business hours upon five (5) business days
notice for
three (3) years following the end of the calendar year to which
they pertain, to
the inspection of Licensor or its agents, no more frequently than
semi-annually,
for the purpose of verifying Licensee's royalty statement or
compliance in other
respects with this Agreement (the "Audit"). This obligation to
maintain accurate
books of account and the right to inspect them shall survive
termination of this
Agreement. Licensee may submit a new statement correcting an