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EXHIBIT 10.11
EXCLUSIVE SUBLICENSE AGREEMENT
Re: UNMC Docket Nos. 63095 series
This Agreement having the effective date of October 10, 2003
("EFFECTIVE DATE")
is made between UNEMED Corporation, 986099 Nebraska Medical Center,
Omaha,
Nebraska 68198-6099 ("UNEMED") and ImaRx Therapeutics,
Incorporated, 1635 East
18th Street, Tucson, AZ 85719 ("LICENSEE").
WHEREAS, the University of Nebraska Medical Center ("UNMC") desires
to license
and otherwise commercialize certain technology resulting from the
research of
its faculty; and
WHEREAS, UNEMED is a biomedical technology development company
charged with and
having authority to assist UNMC in the licensing and commercial
development of
its technology; and
WHEREAS, ImaRx Therapeutics, Incorporated is desirous of licensing
certain UNMC
technology with the intent of furthering its commercial
development;
In consideration of the mutual promises and covenants set forth
below, the
parties hereto agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms shall have the
following
meanings:
1.1 AFFILIATE: any company, corporation, or business in which
LICENSEE owns or
controls at least fifty percent (50%) of the voting stock or other
ownership.
Unless otherwise specified, the term LICENSEE includes
AFFILIATES.
1.2 FIELD: Therapeutic applications of Non-PESDA
(Non-perfluorocarbon enhanced
sonicated dextrose albumin) microbubbles for the treatment of
thrombosis, as
described in UNMC Docket Series 63095.
1.3 UNEMED: UNEMED Corporation, a for-profit Nebraska corporation
having offices
at 701 S. 42nd Street, 986099 Nebraska Medical Center, Omaha,
Nebraska,
69198-6099.
1.4 LICENSED PROCESSES: the processes covered by issued claims of
PATENT RIGHTS,
on a country-by-country basis, that if made used, sold, imported or
offered for
sale would constitute, but for the license granted to Company
pursuant to this
Agreement, an infringement of a claim of PATENT RIGHTS
(infringement shall
include, but is not limited to, direct, contributory, or inducement
to
infringe).
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1.5 LICENSED PRODUCTS: products covered by issued claims of PATENT
RIGHTS , on a
country-by-country basis, that if made, used, sold, imported or
offered for sale
would constitute, but for the license granted to Company pursuant
to this
Agreement, an infringement of a claim of PATENT RIGHTS
(infringement shall
include, but is not limited to, direct, contributory, or inducement
to
infringe).
1.6 LICENSEE: ImaRx Therapeutics, 1635 East 18th Street, Tucson, AZ
85719
1.7 NET SALES: the amount billed, invoiced, or received (whichever
occurs first)
for sales, leases, or other transfers of LICENSED PRODUCTS,
less:
(a)
customary trade, quantity or cash discounts and non-affiliated
brokers'
or agents' commissions actually allowed and taken;
(b)
amounts repaid or credited by reason of rejection or return;
(c)
to the extent separately stated on purchase orders, invoices, or
other
documents of sale, taxes levied on and/or other governmental
charges made as to
production, sale, transportation, delivery or use and paid by or on
behalf of
LICENSEE or sublicensees; and
(d)
reasonable charges for delivery or transportation or insurance
provided
by third parties, if separately stated.
NET
SALES also includes the fair market value of any non-cash
consideration
received by LICENSEE or sublicensees (other than research and
development
payments as set forth in 4.2(a)) for the sale, lease, or transfer
of LICENSED
PRODUCTS.
1.8 NON-COMMERCIAL RESEARCH PURPOSES: use of PATENT RIGHTS for
non-commercial
academic research or other non-commercial scholarly purposes which
are
undertaken at a non-profit or governmental institution; provided
however that
such entity does not use the PATENT RIGHTS in the production or
manufacture of
products for sale or the performance of services for a fee.
1.9 NON-ROYALTY SUBLICENSE INCOME: Sublicense issue fees,
sublicense maintenance
fees, sublicense milestone payments, and similar non-royalty
payments made by
sublicensees to LICENSEE on account of sublicenses pursuant to this
Agreement.
1.10 PATENT RIGHTS:
Patent applications associated with Tech ID # 95009 (the entire
63095 Family)
Title: New Agent for the Treatment of Thrombosis
Patent #
UNMC Docket #
Title (issue date)
-------------
------------------
63095
5,648,098
Thrombolytic Agents and Methods of
Treatment for Thrombosis (issued 7/15/97)
63095.1
5,980,950
Thrombolytic Agents and Methods of
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divisional of 63095)
Treatment for Thrombosis (issued 11/09/99)
63095.2
6,197,345
Thrombolytic Agents and Methods of
(continuation of 63095.1) Treatment for Thrombosis (issued
3/06/01)
63095.3
Filed
Thrombolytic Agents and Methods of
(continuation of 63095.2) Treatment for Thrombosis
(pending)
the inventions disclosed and claimed therein, divisional patent
applications,
issued patents, CIP applications to the extent any new matter reads
on claims of
a parent application, reissued and reexamined patents, all limited
by FIELD to
be included within this agreement, and to the extent they are owned
or
controlled by INSTITUTIONS, any and all foreign patents and patent
applications
corresponding thereto.
1.11 TERRITORY: Worldwide
1.12 The terms "Public Law 96-517" and "Public Law 98-620" include
all
amendments to those statutes.
1.13 The terms "sold" and "sell" include, without limitation,
leases and other
transfers and similar transactions.
1.14 INSTITUTIONS: The Board of Regents of the University of
Nebraska, a public
body corporate, doing business as the University of Nebraska
Medical Center,
986099 Nebraska Medical Center, Omaha, Nebraska, USA,
68198-6099.
ARTICLE II
REPRESENTATIONS
2.1 INSTITUTIONS are owners by assignment from inventor(s) of their
entire
right, title and interest in PATENT RIGHTS, in the foreign patent
applications
corresponding thereto, and in the inventions claimed therein.
2.2 UNEMED has the authority from INSTITUTIONS to issue licenses
under PATENT
RIGHTS. If for any reason UNEMED and INSTITUTIONS terminate their
agreement
providing such authority, or UNEMED ceases to exist, this Agreement
shall
automatically be reassigned to INSTITUTIONS.
2.3 UNEMED is committed to the policy that ideas or creative works
produced at
INSTITUTIONS should be used for the greatest possible public
benefit, and
believes that every reasonable incentive should be provided for the
prompt
introduction of such ideas into public
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use, all in a manner consistent with the public interest.
2.4 LICENSEE is prepared and intends to use commercially reasonable
efforts
develop the invention and to bring to market products, which are
subject to this
Agreement.
2.5 LICENSEE is desirous of obtaining an exclusive license in the
TERRITORY in
order to practice the above-referenced invention covered by PATENT
RIGHTS in the
United States and in certain foreign countries, and to manufacture
or have
manufactured, use, import, sell and have sold in the commercial
market the
products made in accordance therewith, and UNEMED is desirous of
granting such a
license to LICENSEE in accordance with the terms of this
Agreement.
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ARTICLE III
GRANT OF RIGHTS
3.1 UNEMED hereby grants to LICENSEE and LICENSEE accepts, subject
to the terms
and conditions hereof, in the TERRITORY and in the FIELD:
an
exclusive commercial license under PATENT RIGHTS,
to
research and develop, make and have made, to use and have used, to
sell
and have sold, offer for sale and import the LICENSED PRODUCTS, and
to practice
the LICENSED PROCESSES, for the life of the PATENT RIGHTS. Such
licenses shall
include the right to grant sublicenses. In order to provide
LICENSEE with
commercial exclusivity for so long as the license under PATENT
RIGHTS remains
exclusive, UNEMED agrees that it will not grant licenses under
PATENT RIGHTS to
others except as required by INSTITUTIONS' obligations in paragraph
3.2(a) or as
permitted in paragraph 3.2(b) .
3.2 The granting and exercise of this license is subject to the
following
conditions:
(a)
U.S. Public Law 96-517, U.S. Public Law 98-620; if a subject
invention;
the Memorandum of Agreement between the INSTITUTIONS and UNEMED
dated March 31,
1998; the Technology Development Program Agreement dated November
27, 1991 .
(b)
UNEMED on behalf of INSTITUTIONS reserves the right to
(i) make, have made, provide and use for UNEMED's and
INSTITUTION'S
NON COMMERCIAL RESEARCH PURPOSES the subject matter described
and
claimed in PATENT RIGHTS, including the ability to distribute
any
UNEMED- or INSTITUTION-owned materials within the PATENT RIGHTS
for
NON-COMMERCIAL RESEARCH PURPOSES as is customary in the
academic
community.
(ii) grant to others licenses to use and develop the PATENT
RIGHTS
outside of the FIELD of this agreement.
(c)
LICENSEE shall use commercially reasonable efforts to effect
introduction of the LICENSED PRODUCTS or LICENSED PROCESS into the
commercial
market as soon as
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practicable, consistent with sound and reasonable business practice
and
judgment; thereafter, until the expiration of this Agreement,
LICENSEE shall
endeavor to keep LICENSED PRODUCTS or LICENSED PROCESSES reasonably
available to
the public. Licensee shall use commercially reasonable efforts to
meet the
milestones outlined in Section 3.2 (c), (i)-(iii) described
below:
(i) within three (3) years from the EFFECTIVE DATE of this
Agreement,
LICENSEE shall file an IND with the US FDA for a LICENSED PRODUCT
or
LICENSED PROCESS.
(ii) within four (4) years from the EFFECTIVE DATE of this
agreement,
LICENSEE shall commence studies in humans with a LICENSED PRODUCT
or
LICENSED PROCESS.
(iii) within six (6) years from the EFFECTIVE DATE of this
agreement,
LICENSEE shall commence Phase II studies with a LICENSED PRODUCT
or
LICENSED PROCESS.
(d)
At any time after 3 years from the effective date of this
Agreement,
UNEMED may terminate or render this license non-exclusive if, in
UNEMED's
reasonable judgment, the Progress Reports furnished by LICENSEE do
not
demonstrate that LICENSEE has satisfied one of the following:
(i) has succeeded in meeting the milestones as presented in
3.2(c)i-iii, or
(ii) is engaged in research, development, manufacturing, marketing
or
sublicensing activity (which includes making sublicenses
reasonably
available) appropriate to achieving 3.2(d)i, or
(iii) has put the licensed subject matter into commercial use in
at
least one country in the TERRITORY hereby licensed, directly or
through a sublicense, and is keeping the license subject matter
reasonably available to the public.
(e)
In all sublicenses granted by LICENSEE hereunder, LICENSEE
shall
include a requirement that the sublicensee use its commercially
reasonable
efforts to bring the subject matter of the sublicense into
commercial use as
quickly as is reasonably possible. LICENSEE
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shall further provide in such sublicenses that such sublicenses are
subject and
subordinate to the terms and conditions of this Agreement
applicable to a
sublicense, except: (i) the sublicensee may not further sublicense;
and (ii) the
rate of royalty on NET SALES paid by the sublicensee to the
LICENSEE. Copies of
all sublicense agreements shall be provided promptly to UNEMED.
LICENSEE may
redact confidential information from such sublicenses.
(f)
After clinical or other evidence, provided in writing by UNEMED,
to
LICENSEE, reasonably demonstrates the practicality of a particular
use of PATENT
RIGHTS, which is not being developed or commercialized by LICENSEE,
LICENSEE
shall either provide UNEMED with a reasonable development plan and
start
development or attempt to reasonably sublicense of the particular
PATENT RIGHTS
to a third party. If within six (6) months of such notification by
UNEMED,
LICENSEE has not initiated such development efforts or sublicensed
that
particular use of PATENT RIGHTS, UNEMED may reduce the FIELD to the
extent of
such particular use of PATENT RIGHTS, as described in such notice,
of this
license for such particular use of PATENT RIGHTS. This Paragraph
3.2 (f) shall
not be applicable if LICENSEE reasonably demonstrates to UNEMED
that
commercializing such LICENSED PRODUCT(S) or granting such a
sublicense would
have a potentially adverse commercial effect upon marketing or
sales of the
LICENSED PRODUCTS developed and being sold by LICENSEE.
(g) A license in any
other field of use in addition to the FIELD shall be
the subject of a separate agreement and shall require LICENSEE's
submission of
evidence, satisfactory to UNEMED, demonstrating LICENSEE's
willingness and
ability to develop and commercialize in such other field of use the
kinds of
products or processes likely to be encompassed in such other
field.
(h)
During the period of exclusivity of this license in the United
States,
LICENSEE shall cause any LICENSED PRODUCT, if a subject invention,
produced for
sale in the United States to be manufactured substantially in the
United States.
3.3 All rights reserved to the United States Government and others
under Public
Law 96-517, and Public Law 98-620, if a subject invention, shall
remain and
shall in no way be affected by this Agreement.
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ARTICLE IV
ROYALTIES
4.1 LICENSEE shall pay to UNEMED a non-refundable license royalty
fee in the sum
of ten thousand dollars ($10,000.00) upon execution of this
Agreement.
4.2 (a) LICENSEE shall pay to UNEMED during the term of this
Agreement a royalty
of two percent (2% ) of NET SALES by LICENSEE and sublicensees.
Should LICENSEE
be required to pay running royalties to a third party on any patent
rights not
licensed hereunder ("Other Royalties") in order to make, use,
import or sell a
particular LICENSED PRODUCT or LICENSED PROCESS, LICENSEE shall be
entitled to
credit half (50%) of such Other Royalties against the running
royalty due,
provided that the running royalties shall not be reduced below
fifty percent
(50%) of those that would otherwise be due UNEMED for that LICENSED
PRODUCT or
LICENSED PROCESS. In the case of sublicenses, LICENSEE shall also
pay to UNEMED
a royalty of fifty percent (50%) of NON-ROYALTY SUBLICENSE INCOME,
provided that
the sublicense grant is solely for PATENT RIGHTS and grants no
additional rights
(including but not limited to patent, tangible property, know-how,
data,
trademarks) to the sublicense which are owned or controlled by
LICENSEE. Such
consideration shall include any upfront, annual, milestone or other
payments and
value above fair market value of any equity purchased by
sublicensee.
Consideration shall not include any research or development money
paid to
LICENSEE to conduct research in the FIELD pursuant to a research
plan and
budget.
Only one royalty shall be due under this Agreement for any given
LICENSED
PRODUCT or LICENSED PROCESS if covered by multiple patents under
PATENT RIGHTS.
Payment of royalty for any given LICENSED PRODUCT or LICENSED
PROCESS does not
require either determination of infringement or validity of PATENT
RIGHTS prior
to being paid to UNEMED, but rather on presumption of validity. Any
royalties
already paid to UNEMED are nonrefundable should a court of
competent
jurisdiction render a determination of invalidity of PATENT
RIGHTS.
(b)
If the license pursuant to this Agreement is converted to a
non-exclusive one and if other non-exclusive licenses in the same
FIELD and
TERRITORY are granted, the above royalties shall not exceed the
royalty rate to
be paid by other licensees in the same FIELD and TERRITORY during
the term of
the non-exclusive license.
(c)
On sales between LICENSEE and its AFFILIATES or sublicensees
for
resale, the royalty shall be paid on the NET SALES of the AFFILIATE
or
sublicensee.
4.3 No later than January 1 of the third calendar year after the
effective date
of this Agreement,
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as provided below, LICENSEE shall pay to UNEMED the following
non-refundable
license maintenance royalty and/or advance on royalties. Such
payments may be
credited against running royalties due for that calendar year and
Royalty
Reports shall reflect such a credit. Such payments shall not be
credited against
milestone payments (if any) or against royalties due for any
subsequent calendar
year.
January 1, 2006,
$3,000
January 1, 2007 ,
$3,000
January 1, 2008,
$4,000
each year thereafter, $7,000
ARTICLE V
REPORTING
5.1 Prior to signing this Agreement, LICENSEE has provided to
UNEMED a written
research and development plan under which LICENSEE intends to bring
the subject
matter of the licenses granted hereunder into commercial use upon
execution of
this Agreement. Such plan includes projections of sales, proposed
marketing
efforts and the plan for achieving milestones outlined in Article
III, Section
3.2 (c) (i) - (iii). A copy of this plan is included in Appendix A
of this
agreement.
5.2 No later than sixty (60) days after June 30 of each calendar
year, LICENSEE
shall provide to UNEMED a written annual progress report describing
progress on
research and development, regulatory approvals, manufacturing,
sublicensing,
marketing and sales during the most recent twelve (12) month period
ending June
30 and plans for the forthcoming year. If multiple technologies are
covered by
the license granted hereunder, the progress report shall provide
the information
set forth above for each technology. If progress differs from that
anticipated
in the plan required under Paragraph 5.1, LICENSEE shall explain
the reasons for
the difference and propose a modified research and development plan
for UNEMED's
review and approval. LICENSEE shall also provide any reasonable
additional
information UNEMED reasonably request to evaluate LICENSEE's
performance.
5.3 LICENSEE shall report to UNEMED the date of first sale of
LICENSED PRODUCTS
(or results of LICENSED PROCESSES) in each country within sixty
(60) days of
occurrence.
5.4 (a) Upo
