<PAGE>
Exhibit 10.9
Exclusive License Agreement
between
The Regents of the University of California
and
Alsius Corporation
for
Indwelling Heat Exchange Catheter
Case No 99-501
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Table of contents
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Article No.
Title
Page
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RECITALS.................................................................
2
1.
DEFINITIONS................................................
3
2.
GRANT......................................................
5
3.
LICENSE ISSUE FEE..........................................
7
4.
ROYALTIES..................................................
7
5.
DUE DILIGENCE..............................................
9
6.
PROGRESS AND ROYALTY REPORTS...............................
10
7.
BOOKS AND RECORDS..........................................
11
8.
LIFE OF THE AGREEMENT......................................
12
9.
TERMINATION BY THE REGENTS.................................
12
10.
TERMINATION BY THE LICENSEE................................
13
11.
DISPOSITION OF PATENT PRODUCTS ON 1-LAND UPON TERMINATION..
13
12.
USE OF NAMES AND TRADEMARKS................................
13
13.
LIMITED WARRANTY...........................................
14
14.
PATENT PROSECUTION AND MAINTENANCE.........................
15
15.
PATENT MARKING.............................................
17
16.
PATENT INFRINGEMENT........................................
17
17.
INDEMNIFICATION............................................
18
18.
NOTICES....................................................
19
19.
ASSIGNABILITY..............................................
20
20.
LATE PAYMENTS..............................................
20
21.
WAIVER.....................................................
21
22.
FAILURE TO PERFORM.........................................
21
23.
GOVERNING LAWS.............................................
21
24.
GOVERNMENT APPROVAL OR REGISTRATION........................
21
25.
EXPORT CONTROL LAWS........................................
21
26.
FORCE MAJEURE..............................................
22
27.
CONFIDENTIALITY............................................
22
28.
MISCELLANEOUS..............................................
23
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Exclusive License Agreement
for
Alsius Corp.
This
license agreement ("Agreement") is effective this -- day of
November
1999, by and between The Regents of the University of California
("The
Regents"), a California corporation, having its statewide
administrative offices
at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200
acting
through the offices of The University of California, Los Angeles
located at
10945 Le Conte Avenue, Suite 1401, Los Angeles, California
90095-1406, and
Alsius Corporation ("Licensee"), a California corporation, having a
principal
place of business at 15770 Laguna Canyon Road, Suite 150, Irvine,
California
92618.
Recitals
Whereas, certain inventions, characterized as "Indwelling Heat
Exchange
Catheter and Method of Using" ("Invention"), disclosed in UCLA case
number
LA99-501, useful for brain tissue preservation after stroke or
other trauma, as
co-invented at the University of California, Los Angeles by Dr.
Pierre Gobin and
at Alsius by Scott Evans, Mike Jones, and Wayne Noda: and are
claimed in Patent
Rights defined below;
Whereas, Dr. Pierre Gobin is an employee of the University of
California,
Los Angeles and has assigned his rights in the invention to the
Regents;
Whereas, Scott Evans, Mike Jones and Wayne Noda have assigned their
rights
to Alsius;
Whereas, the Licensee is a "small entity" as defined in 37 CFR
Section 1.9
and a "small- business concern" defined in 15 U.S.C. Section
632;
Whereas, both parties recognize that royalties due under this
Agreement
will be paid on pending patent applications and issued patents;
Whereas, the Licensee has requested certain of The Regents' rights
pursuant
to commercializing the Invention; and
Whereas, The Regents responded to the request of the Licensee by
granting
the following rights to the Licensee.
<PAGE>
The parties agree as follows:
1. Definitions
As
used in this Agreement, the following terms will have the meaning
set
forth below:
1.1 "Patent Rights" means all rights in U.S. patents and patent
applications and
foreign patents and patent applications assigned wholly or in part
to The
Regents, including any reissues, extensions, substitutions,
continuations,
divisions, and continuations-in-part applications (only to the
extent, however,
that Dr. Gobin is an inventor of any invention claimed in the
continuation in
part applications and that the subject matter is fully supported
and enabled by
the parent application) based on and including any subject matter
claimed in or
covered by US. Patent Application Serial Number 09/063, 984,
entitled 1ndwelling
Heat Exchange Catheter and Method of Using Same", filed April 21,
1998 and
assigned to The Regents.
1.2 "Patent Products" means:
i.
any kit,
composition of matter, material, or product;
ii.
any kit, composition
of matter, material, or product to be used in -a
manner requiring the performance of the Patent Method; or
iii.
any kit, composition of matter, material, or product produced by
the
Patent Method; to the extent that the manufacture, use, or sale of
such kit,
composition of matter, material, or product, in a particular
country, would
infringe, but for a license or ownership rights therein, a claim of
an issued
and unexpired patent or claim of a pending patent application were
it issued as
a claim in a patent under Patent Rights in that country in which
such patent has
issued or application is pending which claim has not been held
unpatentable,
invalid or unenforceable by a final decision of a court or other
government
agency of competent jurisdiction from which no appeal has or can be
taken and
has not been admitted to be invalid or unenforceable through
reissue,
re-examination, disclaimer or otherwise. This definition of Patent
Products also
includes a service either used by the Licensee or provided by the
Licensee to
its customers when such service requires the practice of the Patent
Method.
3
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1.3 "Patent Method" means any process or method covered by the
claims of a
patent application or patent within Patent Rights or the use or
practice of
which would constitute in a particular country a infringement, but
for a license
or ownership rights therein, of a claim of an issued and unexpired
patent or
claim of a pending patent application were it issued as a claim in
a patent
within Patent Rights in that country in which the Patent Method is
used or
practiced which claim has not been held unpatentable, invalid or
unenforceable
by a final decision of a court or other government agency or
competent
jurisdiction from which no appeal has or can be taken arid has not
been admitted
to be invalid or unenforceable through reissue, re-examination,
disclaimer or
otherwise.
1.4 "Net Sales" means the gross invoice prices from the sale of
Patent Products
by the Licensee, an Affiliate, a Joint Venture, or a sublicensee to
independent
third parties for cash or other forms of consideration in
accordance with
generally accepted accounting principles limited by the following
deductions (if
not already deducted from the gross invoice price and at rates
customary within
the industry): (a) allowances (actually paid and limited to
rejections, returns,
and prompt payment and volume discounts granted to customers of
Patent Products,
whether in cash or Patent Products in lieu of cash); (b) freight,
transport
packing, insurance charges associated with transportation; (c)
taxes, tariff, or
import/export duties based on sales when included in gross sales,
but not
value-added taxes or taxes assessed on income derived from such
sales; and (d)
provisions for uncollectable amounts determined in accordance with
reasonable
accounting practices, consistently applied by the selling party,
Where the
Licensee distributes Patent Products for end use to itself, an
Affiliate, a
Joint Venture, or a sublicensee, then such distribution will be
considered a
sale at the price normally charged to independent third parties,
including
distributors whose pricing is not controlled by Licensee; and The
Regents will
be entitled to collect on such royalty in accordance with Paragraph
1.5. Net
Sales for Patent Products that are kits which include a patented
catheter
licensed hereunder as well as other items such as tubing Sets,
temperature
probes and water cooling systems, the proprietary rights which are
not owned by
The Regents shall be calculated as follows: Net Sales price for a
kit for
4
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purposes of royalties equal net price of kit times the ratio f the
average gross
selling price of a catheter licensed hereunder to the gross selling
price of the
kit.
1.5 "Affiliate(s)" of the Licensee means any entity which, directly
or
indirectly, controls the Licensee, is controlled by the Licensee,
or is under
common control with the Licensee ("control" for these purposes
being defined as
the actual, present capacity to elect a majority of the directors
of such
affiliate, or if not, the power to direct at least forty percent
(40%) of the
voting rights entitled to elect directors) provided, however, that
in any
country where the local law will not permit foreign equity
participation of a
majority, then an "Affihiate will include any company in which the
Licensee owns
or controls, directly or indirectly, the maximum percentage of such
outstanding
stock or voting rights permitted by local law. Each reference to
the Licensee
herein will be meant to include its Affiliates.
1.6 "Joint Venture" means any separate entity established pursuant
to a"
agreement between a third party and the Licensee to constitute a
vehicle for a
joint venture, in which the separate entity manufactures, uses,
purchases,
sells, or acquires Patent Products from the Licensee. Each
reference to the
Licensee herein will be meant to include its Joint Venture(s).
1.7 "Sublicensing Income" means income received by Licensee under
or on account
of Sublicenses. Sublicensing Income includes income received by way
of license
issue fee, milestone payments and the like but specifically
excludes royalties
on the sale or distribution of Licensed Products or the practice of
Licensed
Methods. Not included in the definition of Sublicensing income is
income
received by Licensee as payment or reimbursement for research costs
conducted by
or for Licensee, including costs associated with materials,
equipment, or
clinical testing.
2. Grant
2.1 Subject to the limitations Set forth in this Agreement, The
Regents hereby
grants to the Licensee an exclusive world wide right under The
Regents' interest
in Patent Rights to make, have made, use, sell, offer for sale, and
import
Patent Products and to practice the Patent Method.
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2.2 The manufacture of Patent Products and the practice of the
Patent Method
will be subject to applicable government importation laws and
regulations of a
particular country on Patent Products made outside the particular
country in
which such Patent Products are used or sold.
2.3 The Regents also grants to the Licensee the right to issue
sublicenses to
third parties under the Regents' interest in Patent Rights to make,
have made,
use, sell, offer for sale, and import Patent Products and to
practice Patent
Method, provided the Licensee retains current exclusive rights
thereto under
this Agreement. To the extent applicable, such sublicenses will
include all of
the rights of and obligations due to The Regents (and, if
applicable, the United
States Government) that are contained in this Agreement and
including payment to
The Regents of 25% of Sublicensing Income and payment of royalties
at the rates
provided for in Article 4 (Royalties).
2.4 The Licensee wilt notify The Regents of each sublicense granted
hereunder
and provide The Regents with a copy of each sublicense. The
Licensee will
collect and pay all fees and royalties due The Regents as set forth
in Article 4
below and guarantee all such payments due from the sublicensees.
The Licensee
will require the sublicensees to provide it with progress and
royalty reports in
accordance with the provisions, herein, and the Licensee will
collect and
deliver to The Regents all such reports clue from the
sublicensees.
2.5 Upon termination of this Agreement for any reason, The Regents,
at its sole
discretion, will determine whether any or all sublicenses will be
cancelled or
assigned to The Regents,
2.6 Nothing in this Agreement will be deemed to limit the right of
The Regents
to publish any and all technical data resulting from any research
performed by
The Regents relating to the Invention and to make and use the
invention, Patent
Product(s), Patent Method(s), and associated technology solely for
educational,
clinical, and research purposes and for purposes not covered by
this Agreement.
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3. License Issue Fee
3.1 As partial consideration for all the rights and
licenses granted to the Licensee, the Licensee will pay to The
Regents a
one-time license issue fee of seven thousand dollars ($7000) within
30 days
after the execution of this Agreement by both parties.
3.2 The Licensee will also pay to The Regents a one-time patent
issuance fee of
five thousand dollars ($5,000) upon issuance of the first issued
U.S. Patent
under Patent Rights.
3.3 The fees Set forth above are non-refundable, n n-creditable,
and not an
advance against royalties.
4. Royalties
4.1 As further consideration for all the rights and licenses
granted to the
Licensee, the Licensee and :its sublicensees will pay to The
Regents an earned
royalty at the rate of two and one half percent (2.5%) based on Net
Sales of
Patent Products.
4.2 Paragraphs. 1 1.2, and 1.3 define Patent Rights, Patent
Products, and Patent
Method so that royalties will be payable on Patent Products and
Patent Methods
covered by both pending patent applications and issued patents.
Earned royalties
will accrue in each country for the duration of Patent Rights in
that country
and will be payable to The Regents when Patent Products are
invoiced, or if not
invoiced, when delivered to a third party or to itself, art
Affiliate, Joint
Venture, or the sublicensee in the case where such delivery of the
Patent
Products to the Licensee, an Affiliate, Joint Venture, or the
sublicensee is
intended for end use.
4.3 Royalties accruing to The Regents will be paid to The Regents
quarterly on
or before the following dates of each calendar year:
February 28 for the calendar quarter ending December 31;
May 31 for the calendar quarter ending March 31;
August 31 for the calendar quarter ending June 30; and
November 30 for the calendar quarter ending September 30.
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4.4 Each such payment will be for royalties which accrued up to the
most
recently completed calendar quarter of the Licensee.
4.5 Beginning in the year of the first sale of a Patent Product,
and ending on
the expiration of the Patent Rights, the Licensee will pay to The
Regents a
minimum annual royalty in the amounts and at the times set forth
below:
Year 1 $5000
Year 2 $10,000
Year 3 $15,000
Year 4 and Thereafter $20,000
This minimum annual royalty will be paid to The Regents by February
28 of each
year and will be credited against the earned royalty due and owing
for the
calendar year in which the minimum payment was made.
4.6 A one-time $100,000 milestone payment will be paid for the
first FDA
approval of a Patent Product. No other milestone payments are
contemplated
hereunder for subsequent, if any, FDA approvals of Patent
Products.
4.7 All monies due The Regents will be payable in United Slates
funds
collectible at par in San Francisco, California. When Patent
Products are sold
for monies other than United States dollars, the earned royalties
will first be
determined in the foreign currency of the country in which such
Patent Products
were sold and then converted into equivalent United States funds.
The exchange
rate will be that rate quoted in the Wall Street Journal on the
last business
day of the reporting period.
4.8 Earned royalties on sales of Patent Products occurring in any
country
outside the United States will not be reduced by any taxes, fees,
or other
charges imposed by the government of such country except those
taxes, fees, and
charges allowed under the provisions of Paragraph 1.4 (Net Sales).
The Licensee
will also be responsible for all bank transfer charges.
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4.9 Notwithstanding the provisions of Article 26 (Force Majeure) if
at any time
legal restrictions prevent prompt remittance of part or all
royalties owed to
The Regents by the Licensee with respect to any country where a
Patent Product
is sold or distributed, the Licensee will convert the amount owed
to The Regents
into United States funds and will pay The Regents directly from
another source
of funds for the amount impounded.
4.10 In the event that any patent or any claim thereof included
within the
Patent Rights is held invalid in a final decision by a court of
competent
jurisdiction and last resort and from which no appeal has or can be
taken, all
obligation to pay royalties based on such patent or claim or any
claim
patentably indistinct therefrom will cease as of the date of such
final
decision. The Licensee will not, however, be relieved from paying
any royalties
that accrued before such decision or that are based on another
patent or claim
that has not expired or that is not involved in such decision.
5. Due
Diligence
5.1 The Licensee shall, upon execution of this Agreement and
subject to all
applicable laws and regulations, diligently proceed with the
development,
manufacture, and sale of Patent Products and will earnestly and
diligently
market the same after execution of this Agreement and in quantities
sufficient
to meet the market demands therefore. The Licensee wil1 be entitled
to exercise
prudent and reasonable business judgment in the manner in which it
meets its due
diligence obligations hereunder. In no case, however, will the
Licensee be
relieved of its obligations to meet the due diligence provisions of
this
Article.
5.2 The Licensee will use reasonable efforts to obtain all
necessary
governmental approvals in each country chosen by licensee in its
sole discretion
for the manufacture, use, and sale of Patent Products.
5.3 If the Licensee is unable to perform any of the following
5.3(a) Feasibility Study: Treatment of 10 patients to be completed
by
July
2000.
5.3(b) Multicenter Clinical Trial of 100 patients to be completed
by
July
2001
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5.3(c) FDA/Preapproval to be completed by February 2002; then
The
Regents will have the right and option to terminate this Agreement
or
reduce the exclusive licenses granted to the Licensee to
non-exclusive
licenses in accordance with the provisions hereof. The exercise of
this
right and option by The Regents supersedes the rights granted in
Article 2
(Grant). The Licensee may request a one-year extension of time
during the
term
of the License which will not be unreasonably withheld by The
Regents
upon
appropriate justification by Licensee if Licensee fails to meet
any
one
of the diligence dates set forth above.
6. Progress and Royalty Reports
6.1 Beginning May 1, 2000 and semi-annually thereafter, the
Licensee will submit
to The Regents a progress report covering activities by the
Licensee related to
the development and testing of all Patent Products and the
obtaining of the
governmental approvals necessary for marketing them. These progress
reports will
be provided to The Regents to cover the progress of the research
and development
of the Patent Products until their first commercial sale in the
United States.
6.2 The progress reports submitted under Paragraph 6.1 will
include, but not be
limited to, the following topics so that The Regents may be able to
determine
the progress of the development of Patent Products and may also be
able to
determine whether or not the Licensee has met its diligence
obligations set
forth in Article 5 above:
6.2(a) Summary of work completed.
6.2(b) Key scientific discoveries.
6.2(c) Summary of work in progress.
6.2(d) Current schedule of anticipated events or milestones.
6.2(e) Market introduction date of Patent Products.
6.2(f) A summary of resources (dollar value) spent in the reporting
period.
6.2(g) Activities of the sublicensees, if any.
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6.2(h) Patents flied by Licensee per Paragraph 14.1
All reports hereunder shall be handled as a Confidential material
by The Regents
if so marked.
6.3 The Licensee will also report to The Regents in its immediately
subsequent
progress and royalty report the date of first commercial sale of a
Patent
Produc