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Exhibit 10.9
LICENSE AGREEMENT
THIS
AGREEMENT is made by and between the Board of Trustees of the
University of Arkansas acting for and on behalf of the UNIVERSITY
OF ARKANSAS
FOR MEDICAL SCIENCES, a public institution of higher education
having principal
offices at 2404 North University Avenue, Little Rock, Arkansas
72207 United
States of America (hereinafter "UNIVERSITY"), and IMARX
THERAPEUTICS, INC.
having a principal place of business at 1635 East 18th Street,
Tucson, Arizona
85719 (hereinafter "LICENSEE").
WITNESSETH
WHEREAS, UNIVERSITY is the owner of certain PATENT RIGHTS (as later
defined
herein) relating to certain technology invented by UNIVERSITY
employees and
students of the UNIVERSITY and has the right to grant licenses
under said PATENT
RIGHTS; and
WHEREAS, UNIVERSITY desires to have the PATENT RIGHTS developed
and
commercialized to benefit the public and is willing to grant
licenses there
under; and
WHEREAS, LICENSEE desires to obtain a license under the PATENT
RIGHTS upon
the terms and conditions hereinafter set forth.
NOW,
THEREFORE, in consideration of the premises and the mutual
covenants
contained herein, the Parties hereto agree as follows:
ARTICLE 1 - EFFECTIVE DATE
This
Agreement shall be effective as of February 10, 2006 (hereinafter
the
"EFFECTIVE DATE").
ARTICLE 2
- DEFINITIONS
For
the purposes of this Agreement, the following words and phrases
shall
have the following meaning:
2.1 "PATENT RIGHTS" shall mean all of the following UNIVERSITY
intellectual
property:
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(a)
the United States and foreign patents and/or patent applications
listed
in
Appendix A attached hereto, and corresponding foreign patents
and/or
foreign patent applications; and
(b)
United States patents issued from the applicatians listed in
Appendix A
and
from applications for divisionals, continuations,
continuations-in-part, reexaminations and reissues of the patents
and/or
applications listed in Appendix A and any divisionals,
continuations,
continuations-in-part,
re-examinations and reissues issued from such
applications and foreign patents issued from corresponding foreign:
patent
applications.
(c)
As used in this Agreement, the term "patent" means (i)
unexpired
letters patent (including inventor's certificates) including,
without
limitation, any substitution, extension (such as supplementary
protection
certificates), registration, confirmation, reissue,
re-examination.
renewal, or any like filing thereof, and (ii) pending applications
for
letters patent, including without limitation any continuation,
division or
continuation-in-part thereof and any provisional applications, and
any
foreign counterparts and all patents that issue there from.
2.2 "LICENSED PRODUCT"
shall mean any product or part thereof which:
(a)
but for the license granted herein would infringe in whole or in
part
upon
an issued, unexpired, valid claim or a pending claim contained in
the
PATENT RIGHTS in the country in which any such product or part
thereof is
made, used or sold; or
(b)
is manufactured by using a process or is employed to practice a
process
which, but for the license granted herein, would infringe in whole
or in
part
upon an issued, unexpired valid claim or a pending claim contained
in
the
PATENT RIGHTS in the country in which any LICENSED PROCESS is used
or
in
which such product or part thereof is used or sold.
2.3 A "LICENSED PROCESS" shall mean any process, which is covered
in whole or in
part by an issued, unexpired, valid claim, or a pending claim
contained in the
PATENT RIGHTS.
2.4 "NET SALES" shall mean the gross revenues received by LICENSEE
and its
agents, Affiliates, sublicensees and third parties for the sale of
LICENSED
PRODUCTS less: returns, allowances, and discounts actually granted;
packing,
insurance, freight out, taxes or excise duties imposed on the
transaction (if
separately invoiced); wholesaler discounts and cash discounts.
No
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deductions shall be made for commissions paid to individuals
regularly employed
by LICENSEE and on its payroll, or for cost of collections.
Notwithstanding the
foregoing, Net Sales shall not include any revenues with respect
to: (i) any
LICENSED PROCESS or (ii) with respect to any product which is a
LICENSED PRODUCT
solely with respect to claims 23 through 26 of US Patent No.
6,945,937, and any
corresponding claims in any other patent included in the PATENT
RIGHTS, it being
the intent of the parties that the rights of LICENSEE hereunder
with respect to
any LICENSED PROCESS and the foregoing claims shall be royalty
free.
2.5 "FIRST COMMERCIAL SALE" shall mean the initial transfer by or
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.
2.6 "LICENSEE" is understood to include all of its Affiliates. An
Affiliate of
LICENSEE shall mean any corporation or other business entity
controlled by,
controlling or under common control with LICENSEE, For this
purpose, "control"
means direct or indirect beneficial ownership of at least fifty
percent (50%) of
the voting stock, or at least fifty percent (50%) interest in the
income of such
corporation or other business.
2.7 "TERRITORY" shall mean the world.
2.8 "LICENSED FIELD" shall mean all applications.
ARTICLE 3 - GRANT
3.1 UNIVERSITY hereby grants to LICENSEE an exclusive right and
license in the
TERRITORY for the LICENSED FIELD to practice under the PATENT
RIGHTS and to
make, have made, use, offer for sell, sell and import LICENSED
PRODUCTS and to
practice the LICENSED PROCESSES. Such licenses are hereby granted
until the end
of the term of the PATENT RIGHTS unless this Agreement shall be
sooner
terminated according to the terms hereof.
3.2 LICENSEE shall have the right to grant sublicenses consistent
with this
Agreement provided that LICENSEE shall be responsible for the
operations of its
sublicenses relevant to this Agreement as if such operations were
carried out by
LICENSEE, including the payment of royalties whether or not paid to
LICENSEE by
a sublicensee. LICENSEE further agrees to deliver to UNIVERSITY a
true and
correct copy of each sublicense granted to LICENSEE, and
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any modification or termination thereof, within thirty (30) days
after
execution, modification, or termination, which University shall
maintain in
confidence per the terms of Article 17. Upon termination of this
Agreement, any
and all existing sublicenses granted by LICENSEE shall survive and
shall be
assigned to UNIVERSITY.
3.3 UNIVERSITY reserves the right to make and to use and to grant
nonexclusive
licenses to non-profit entities to make and to use, for research
purposes only
and not for any commercial purpose the technology and the subject
matter
described and claimed in the PATENT RIGHTS.
ARTICLE 4 - DUE DILIGENCE
4.1 LICENSEE shall use commercially reasonable efforts to bring one
or more
LICENSED PRODUCTS to market through an active and diligent program
for
exploitation of the PATENT RIGHTS and to continue active, diligent
marketing
efforts for one or more LICENSED PRODUCTS throughout the life of
this Agreement.
4.2 In addition, LICENSEE shall use commercially reasonable efforts
to adhere to
the following milestones:
(a)
LICENSEE shall deliver to UNIVERSITY on or before nine (9) months
after
the
execution of this Agreement the preliminary business and FDA
application and approval plans showing each phase of development
of
LICENSED PRODUCTS and shall provide similar reports to UNIVERSITY
in
accordance with Article 6.3 hereof.
(b)
LICENSEE shall develop an animal model / testing protocol of
LICENSED
PRODUCT on or before two years after execution of this
Agreement.
(c)
LICENSEE shall proceed diligently toward obtaining appropriate
United
States regulatory approval for marketing LICENSED PRODUCTS and
shall show
appropriate and reasonable evidence toward same within five years
of
entering into Agreement.
4.3 LICENSEE's continued failure to perform in accordance with
Articles 4.1 and
4.2 above for a period of 45 days after receiving from UNIVERSITY
written notice
of default thereon, shall be grounds for UNIVERSITY, at sole option
of
UNIVERSITY, to terminate this Agreement pursuant to Article 10
hereof or render
this license nonexclusive. In making this decision, UNIVERSITY
shall take into
account the normal course of such activities conducted with
sound
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and reasonable business practices and judgment and shall take into
account the
reports provided hereunder by LICENSEE.
ARTICLE 5 - ROYALTIES AND OTHER CONSIDERATION
5.1 For the rights, privileges and license granted hereunder,
LICENSEE shall pay
royalties and other compensation to UNIVERSITY in the manner
hereinafter
provided to the end of the term of the PATENT RIGHTS or until this
Agreement
shall be earlier terminated:
(a)
LICENSEE shall pay to UNIVERSITY on or before thirty (30) days
after
the
EFFECTIVE DATE one half ($7,500) of a nonrefundable initial
license
fee
of fifteen thousand dollars ($15,000) and the balance of $7,500 on
or
before the first anniversary of the EFFECTIVE DATE.
(b)
LICENSEE shall pay to UNIVERSITY twenty-five thousand dollars
($25,00O)
within thirty (30) days after the FIRST COMMERCIAL SALE in the
U.S.
(c)
LICENSEE shall pay to UNIVERSITY a minimum annual royalty in
accordance
with
the following schedule:
(i) $5,000 per year
commencing February 10, 2007, increasing to
(ii) $7,000 per year on February 10, 2009, and each year
thereafter.
Such
minimum royalty payments shall be offset against University
Royalties
due
during the applicable year.
(d)
LICENSEE shall pay to UNIVERSITY the following running
royalties
("UNIVERSITY Royalties"):
(i) 4.0% of NET SALES
of up to $1M;
(ii) 3.0% of NET SALES greater than $1M, but less than $10M;
(iii) 2.0% of NET SALES greater than $10M.
Provided, however, that the total royalty payments paid by LICENSEE
to
UNIVERSITY shall not exceed $20M, and the license granted hereunder
shall
be
royalty free after such amount has been paid.
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(e)
A one-time success payment of $250,000 in the first year that
the
aggregate Net Sales of LICENSED PRODUCTS exceeds $10M. This payment
shall
be
made in addition to any royalties due.
(f)
Third Party Payments: LICENSEE shall pay UNIVERSITY fifteen
percent
(15%) of lump-sum non-royalty consideration actually received by
LICENSEE
from
third party (ies) under a sublicensing agreement with LICENSEE;
provided that, if LICENSEE has added substantial value or
improvement to
the
LICENSED PRODUCTS, LICENSEE shall pay UNIVERSITY seven and
one-half
percent (7.5%) of such consideration. Substantial value or
improvement is
defined as FDA / regulatory approval for marketing LICENSED
PRODUCTS. The
foregoing payment obligation shall not apply with respect to
consideration
related to the provision of goods, services or equity ownership by
LICENSEE
to
any sublicensee.
(g)
LICENSEE shall pay one hundred percent (100%) of the costs incurred
in
the
preparation, filing, prosecution (including appeals, interferences,
and
other ex parte and inter partes proceedings) and maintenance of
patent
applications and patents by UNIVERSITY as of the EFFECTIVE DATE
in
accordance with the following schedule:
(i) $15,000 on the
execution of this agreement and
(ii) The balance of all patent costs incurred prior to the
EFFECTIVE
DATE twelve (12) months from the EFFECTIVE DATE of this
agreement.
(h)
Should LICENSEE be required to pay royalties to a third party
with
respect to any patent rights of such third party ("Other
Royalties") in
order to make, have made, use, offer for sell, sell or import a
particular
LICENSED PRODUCT, LICENSEE
shall be entitled to credit such Other Royalties
against the UNIVERSITY royalties due hereunder, provided that
the
UNIVERSITY royalties shall not be reduced below fifty percent (50%)
of
those that would otherwise be due UNIVERSITY.
5.2 All amounts payable hereunder by LICENSEE shall be paid in
full, without
deduction of taxes or other fees which may be imposed by any
government and
which shall be paid by LICENSEE.
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5.3 No multiple or cumulative royalties shall be payable because
any LICENSED
PRODUCT or LICENSED PROCESS, its manufacture, use, lease or sale
are or shall be
covered by more than one PATENT RIGHTS patent application or PATENT
RIGHTS
patent licensed under this Agreement.
5.4 All sales or use of LICENSED PRODUCTS by LICENSEE, excepting
sales under
Article 8.1 to an Affiliate or another LICENSEE of UNIVERSITY,
shall be subject
to royalty payments as provided.
ARTICLE 6 - RECORDS AND REPORTS
6.1 LICENSEE shall keep full, true and accurate books of account
containing all
particulars that may be necessary for the purpose of showing the
amounts payable
to UNIVERSITY hereunder. Said books of account shall be kept at
LICENSEE's
principal place of business or the principal place of business of
the
appropriate operating, subsidiary of LICENSEE to which this
Agreement relates.
Said books and the supporting data shall be open, to the extent
relevant to the
licenses granted hereunder, at all reasonable times for Five (5)
years following
the end of the calendar year to which they pertain, to the
inspection of
UNIVERSITY or his agents for the purpose of verifying LICENSEE's
royalty
statement or compliance in other respects with this Agreement.
Should such
inspection lead to the discovery of a greater than ten percent
(10%) discrepancy
in reporting to UNIVERSITY's detriment, LICENSEE agrees to pay the
full cost of
such inspection actually incurred by UNIVERSITY.
6.2 LICENSEE shall report to UNIVERSITY the date of first sale of a
LICENSED
PRODUCT or LICENSED PROCESS in each country within thirty (30) days
occurrence.
6.3 Prior to the FIRST COMMERCIAL SALE, LICENSEE shall make annual
progress
reports to UNIVERSITY regarding both the milestones listed in
Article 4 and
other measures of product development. These reports are due June
30 following
the EFFECTIVE DATE and prior to the FIRST COMMERCIAL SALE.
6.4 After the FIRST COMMERCIAL SALE of a LICENSED PRODUCT or
LICENSED PROCESS,
LICENSEE, within sixty (60) days after March 31, June 30, September
30, and
December 31 of each year, shall deliver to UNIVERSITY true and
accurate reports,
giving such particulars of the business conducted by LICENSEE and
its
sublicensees with respect to the LICENSED PRODUCTS and LICENSED
PROCESSES during
the preceding three-month
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period under this Agreement as shall be pertinent to a royalty
accounting
hereunder. These shall include at least the following:
(a) quantity of LICENSED PRODUCTS
manufactured and sold by LICENSEE;
(b)
quantity of LICENSED
PRODUCTS manufactured and sold by each
sublicensee;
(c)
total receipts for
LICENSED PRODUCTS sold by LICENSEE;
(d)
total receipts by
LICENSEE for LICENSED PRODUCTS sold by each
sublicensee;
(e)
receipts for all
LICENSED PROCESSES used or sold by LICENSEE
(f)
receipts for all
LI