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
Table of contents
Article No. Title Page
----------- ----- ----
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
i
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 0000 Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000 acting
through the offices of The University of California, Los Angeles located at
00000 Xx Xxxxx Xxxxxx, Xxxxx 0000, Xxx Xxxxxxx, Xxxxxxxxxx 00000-0000, and
Alsius Corporation ("Licensee"), a California corporation, having a principal
place of business at 00000 Xxxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxx, Xxxxxxxxxx
00000.
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 Xx. Xxxxxx Xxxxx and
at Alsius by Xxxxx Xxxxx, Xxxx Xxxxx, and Xxxxx Xxxx: and are claimed in Patent
Rights defined below;
Whereas, Xx. Xxxxxx Xxxxx is an employee of the University of California,
Los Angeles and has assigned his rights in the invention to the Regents;
Whereas, Xxxxx Xxxxx, Xxxx Xxxxx and Xxxxx Xxxx 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.
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 Xx. Xxxxx 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.
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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
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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 xxxx 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
Product(s) In each country.
6.4 After the first commercial sale of a Patent Product, the Licensee will
provide The Regents with quarterly royalty reports to The Regents on or before
each February 28, May 31 August 31, and November 30 of each year. Each such
royalty report will cover the most recently completed calendar quarter of the
Licensee (October through December, January through March, April through June,
and July through September) and will show:
6.4(a) Gross sales and Net Sales of Patent Products sold by the Licensee and
reported to the Licensee as sold by its sublicensees during the most recently
completed calendar quarter.
6.4(b) Number of Patent Products sold or distributed by the Licensee and
reported to the Licensee as sold or distributed by its sublicensees.
6.4(c) Royalties, in U.S. dollars, payable hereunder with respect to Net Sales:
and the exchange rates used if any.
6.5 If no sales of Patent Products have been made during any reporting period
after the first commercial sale of a Patent Product, then a statement to this
effect is required.
7. Books and Records
7.1 The Licensee will keep books and records accurately showing all Patent
Products manufactured, used, and/or sold under the terms of this Agreement. Such
books and records will be preserved for at least five years after the date of
the royalty payment to which they pertain and will be open to inspection by
representatives or agents of The Regents at reasonable times to determine the
accuracy of the books and records and to determine compliance by the Licensee
with the terms of this Agreement.
7.2 The fees and expenses of representatives of The Regents performing such an
examination will be borne by The Regents. However, if an error in royalties of
more than five percent (5%)
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of the total royalties due for any year is discovered, then the fees and
expenses of these representatives will be borne by the Licensee.
8. Life of the Agreement
8.1 Unless otherwise terminated by operation of law or by acts of the parties in
accordance with the terms of this Agreement, this Agreement will be in force
from the effective date recited on page one and will remain in effect for the
life of the last-to-expire patent licensed under this Agreement, or until the
last patent application licensed under this Agreement is abandoned. Any
termination of this Agreement will not affect the rights and obligations set
forth in the following Articles:
Article 7 Books and Records
Article 11 Disposition of Patent Products on Hand Upon Termination
Article 12 Use of Names and Trademarks
Article 17 Indemnification
Article 22 Failure to Perform
Article 27 Confidentiality
8.2 Any termination of this Agreement shall not relieve the Licensee of its
obligation to pay any monies due or owing at the time of such termination and
shall not relieve any obligations, of either party to the other party,
established prior to termination.
9. Termination by The Regents
9.1 If the Licensee should violate or fail, to perform any term or covenant of
this Agreement, then The Regents may give written notice of such default
("Notice of Default") to the Licensee. If the Licensee should fail to repair
such default within 60 days after the date of such notice takes effect, The
Regents will have the right to terminate this Agreement and the licenses herein
by a second written notice ("Notice of Termination") to the Licensee, If a
Notice of Termination is sent to the Licensee, this Agreement will automatically
terminate on the date such notice takes effect. Such termination will not
relieve the Licensee of its obligation to pay any royalty or
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license fees owing at the time of such termination and will not impair any
accrued right of The Regents. These notices will be subject to Article 18
(Notices).
10. Termination by the Licensee
10.1 The Licensee will have the right at any time to terminate this Agreement in
whole or as to any portion of Patent Rights by giving notice in writing to The
Regents. Such notice of termination will be subject to Article 18 (Notices) and
termination of this Agreement will be effective 90 days after the effective date
thereof.
10.2 Any termination pursuant to the above paragraph will not relieve the
Licensee of any obligation or liability accrued hereunder prior to such
termination or rescind anything done by the Licensee or any payments made to The
Regents hereunder prior to the time such termination becomes effective, and such
termination will not affect in any manner any rights of The Regents arising
under this Agreement prior to such termination. Such termination will not
relieve the Licensee of its obligation to pa any fees or royalties owing at the
time of such termination and will not impair any accrued right of The Regents.
11. Disposition of Patent Products on 1-land Upon Termination
11.1 Upon termination of this Agreement, the Licensee will continue to have the
privilege of selling Patent Products under its own rights in the patents.
12. Use of Names and Trademarks
12.1 Neither party is permitted to use any name, trade name, trademark or other
designation of the other party or its employees (including contraction,
abbreviation or simulation of any of the foregoing) in advertising, publicity or
other promotional activity. Unless required by law, Licensee is expressly
prohibited from using the name 44The Regents of the University of California" or
the name of any campus of the University of California.
12.2 It is understood that The Regents will be free to release to the inventors
and senior administrative officials employed by The Regents the terms of this
Agreement upon their request. If such release is made, The Regents will require
that such terms will be kept in confidence in accordance with the provisions of
Article 27 (Confidentiality) and not be disclosed
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to others. It is further understood that should a third party inquire whether a
license to Patent Rights is available, The Regents may disclose the existence of
this Agreement and the extent of the grant in Article 2 (Grant) to such third
party, but will not disclose the name of the Licensee, except where The Regents
are required to release such information under either the California Public
Records Act or other applicable law. Any release of information by The Regents
under this paragraph shall be promptly reported in writing to Licensee.
13. Limited Warranty
13.1 The Regents warrant to the Licensee that they have the lawful right to
grant this license. This license and the associated Invention, Patent Rights,
Patent Products, and Patent Methods are provided WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY,
EXPRESS OR IMPLIED. THE REGENTS MAKE NO REPRESENTATION OR WARRANTY THAT THE
INVENTION, PATENT RIGHTS, PATENT PRODUCTS, OR PATENT METHOD WILL NOT INFRINGE
ANY PATENT OR OTHER PROPRIETARY RIGHT.
13.2 IN NO EVENT WILL THE REGENTS BE LIABLE FOR ANY INCIDENTAL, SPECIAL, OR
CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR THE USE OF THE
INVENTION, PATENT RIGHTS, PATENT METHOD, OR PATENT PRODUCTS.
13.3 Nothing in this Agreement will be construed as:
13.3(a) A warranty or representation by The Regents as to the validity,
enforceability, or scope of any Patent Rights.
13.3(b) A warranty or representation that anything made, used, sold, or
otherwise disposed of under any license granted in this Agreement is or will be
free from infringement of patents of third parties.
13.3(c) An obligation to bring or prosecute actions or suits against third
parties for patent infringement except as provided in Article 16 (Patent
Infringement).
13.3(d) Conferring by implication, estoppel, or otherwise any license or rights
under any patents of The Regents other than Patent Rights as defined herein,
regardless of whether such patents are dominant or subordinate to Patent Rights.
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13.3 (e) An obligation to furnish any know-how not provided in Patent Rights or
Patent Products.
14. Patent Prosecution and Maintenance
14.1 Licensee will, diligently prosecute and maintain the United States and
foreign patents comprising Patent Rights using counsel of its choice, Licensee
will promptly inform The Regents of prosecution events and provide the Regents
with copies of all relevant documentation so that The Regents may be currently
and promptly informed and apprised of the continuing prosecution, and may
comment upon such documentation sufficiently in advance of any initial deadline
for filing a response, provided, however, that if The Regents have not commented
upon such documentation prior to the initial deadline for filing a response with
the relevant government patent office, Licensee will be free to respond
appropriately without consideration of comments by The Regents, if any. Both
parties hereto will keep this documentation in confidence in accordance with the
provisions of Article 27 (Confidentiality) herein. Counsel for Licensee will
take instructions only from Licensee.
So that The Regents may be assured that their patent rights are protected,
Licensee will submit each U.S. patent application (under strict confidentiality)
that is to be filed by Licensee to The Regents' designee for review 30 days
prior to filing where practical, regardless of whether Licensee has named an
employee of The Regents as inventor on the application. If, in The Regents'
opinion, an application fails to set forth proper inventorship, Licensee and The
Regents will cooperate to resolve any such nonjoinder or misjoinder, hi the
event that a dispute over inventorship cannot be resolved by such cooperation,
The Regents shall have the right, but not the obligation, to appoint
disinterested patent counsel (i.e., patent counsel who have not previously
represented The Regents or Licensee) paid for by Licensee to render an opinion
as to the disputed inventorship. Both parties hereto agree to be bound by any
such opinion.
14.2 Licensee will use all reasonable, efforts to amend any patent application
to include claims requested by The Regents.
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14.3 Licensee intends to file, prosecute, and maintain patent applications and
patents covered by Patent Rights in foreign countries if available, and will
keep The Regents apprised of its activities in this regard by providing The
Regents with a list of elected countries. Should The Regents desire patent
protection in countries not elected by Licensee, The Regents will timely notify
Licensee of their desire to file patent applications in such countries. Licensee
will cooperate with The Regents to file patent applications in such non-elected
countries. The Regents will have the right to tile patent applications at their
own expense in any country Licensee has not included in its list of desired
countries, and such applications and resultant patents, if any, will not be
included in the licenses granted under this Agreement.
14.4 All past, present and future costs of preparing, filing, prosecuting and
maintaining all United States and foreign patent applications and all costs and
fees relating to the preparation and filing of patents covered by Patent Rights
in Paragraph 1.1 and costs under Paragraph 14.1 will be borne by the Licensee
including cost of Regents counsel to review and provide comment on preparation,
filing, and prosecuting of Patent Rights with the exception of the costs
discussed above in relation to non-elected countries in Paragraph 13.4, provided
that any fees or costs incurred by The Regents in excess of $5,000 for which The
Regents expect reimbursement are preapproved in writing by Licensee, such
preapproval is not to be unreasonably withheld by Licensee. Licensee will
reimburse The Regents for patent preparation and prosecution costs for this
Invention incurred by The Regents prior to the execution of this Agreement. Such
costs will be due upon execution of this Agreement and will be payable at the
time that the license issue fee is payable. The costs of all interferences and
oppositions will be considered prosecution expenses and also will be borne by
the Licensee. The Licensee will reimburse The Regents for all costs and charges
within 30 days following receipt of an itemized invoice from The Regents for
same.
14.5 Licensee's obligation to underwrite and to pay all United States and
foreign patent costs will continue for as long as this Agreement remains in
effect. Licensee may terminate its obligations to any given patent application
or patent upon three months written notice to The
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Regents. The Regents will use its best efforts to curtail patent costs
chargeable to Licensee under this Agreement after this notice is received from
Licensee. The Regents may continue prosecution or maintenance of these
application(s) or patent(s) at its sole discretion and expense, and Licensee
will have no further rights or licenses to them.
14.6 The Licensee will notify The Regents of any change of its status as a small
entity (as defined by the United States Patent and Trademark Office) and of the
first sublicense granted to an entity that does not qualify as a small entity as
defined therein.
15. Patent Marking
15.1 The Licensee will xxxx all Patent Products made, used, or sold under the
terms of this Agreement, or their containers, in accordance with the applicable
patent marking laws.
16. Patent Infringement
16.1 In the event that either party (but The Regents only through it's
Technology Transfer Officer responsible for this case) learns of the substantial
infringement of any patent in Patent Rights, each party will inform, the other
in writing and Licensee will provide The Regents with reasonable evidence of the
infringement. During the period and in a jurisdiction where Licensee has
exclusive rights under this Agreement, neither party will notify a third party
of the infringement of any of Patent Rights without first obtaining consent of
the other party, which consent must not be unreasonably denied. Both parties
will use their best efforts to cooperate to terminate the infringement without
litigation.
16.2 In order to take legal action for infringement, Licensee must request that
The Regents join them to take legal action against the infringement of Patent
Rights. This request must be in writing and must include reasonable evidence of
the infringement and the damages to Licensee. If the infringing activity has not
been abated within 90 days following the effective date of the request, The
Regents has the right to (a) join with the Licensee to commence suit against the
infringer or (b) refuse to participate in a suit. The Regents must give notice
of its election in writing to Licensee by the end of the 100th day after
receiving notice of the request from Licensee But, should The Regents determine
before the 100th day that they do not wish to join
17
the suit they will notify Licensee as soon as possible. Licensee may thereafter
bring suit for patent infringement in its own name if and only if The Regents
elected not to commence Suit and if the infringement occurred during the period
and in a jurisdiction where the third party had allegedly infringed Licensee's
exclusive rights under this Agreement. However, in the event Licensee elects to
bring suit in accordance with this Paragraph 16.2, The Regents may thereafter
join the suit at its own expense.
16.3 Such legal action as is decided upon will be at the expense of the party on
account of whom suit is brought and all recoveries recovered thereby will belong
to such party, provided, however, that legal action brought jointly by The
Regents and the Licensee and participated in by both will be at the joint
expense of the parties and all recoveries will be allocated in the following
order: a) to each party reimbursement in equal amounts of the attorneys costs,
fees, and other related expenses to the extent each party paid for such costs,
fees, and expenses until all such costs, fees, and expenses are consumed for
each party; and b) any remaining amount shared jointly by them in proportion to
the share of expenses paid by each party.
16.4 Each party will cooperate with the other in litigation proceedings
instituted hereunder but at the expense of the party on account of whom suit is
brought. Such litigation will be controlled by the party bringing the suit,
except that The Regents may be represented by counsel of its choice in any suit
brought by the Licensee.
17. Indemnification
17.1 Licensee will (and require its sublicensees to) indemnify, hold harmless,
and defend The Regents, its officers, employees, and agents; the sponsors of the
research that led to the Invention; the inventors of any invention covered by
patents or patent applications in Patent Rights (including the Patent Products
and Patent Method contemplated thereunder) and their employers against any and
all claims, suits, losses, damage, costs, fees, and expenses resulting from or
arising out of exercise of this license or any sublicense. This indemnification
will include, but will not be limited to, any product liability.
18
17.2 As a condition to using or selling the Patent Products in humans, Licensee,
at its sole cost and expense, will insure its activities in connection with the
work under this Agreement and obtain, keep in force, and maintain insurance as
follows: (or an equivalent program of self insurance)
17.3 Comprehensive or Commercial Form General Liability Insurance (contractual
liability included) with limits as follows:
Each Occurrence............................. $5,000,000
Products/Completed Operations Aggregate..... $5,000,000
Personal and Advertising Injury............. $5,000,000
General Aggregate (commercial form only).... $5,000,000
The Licensee will furnish The Regents with certificates of insurance evidencing
compliance with all requirements. Such certificates will:
17.3(a) Provide for 30 day advance written notice to The Regents of any
modification.
17.3(b) Indicate that The Regents has been endorsed as an additional Insured
under the coverages referred to under the above.
17.3(c) Include a provision that the coverages will be primary and will not
participate with nor w11 be excess over any valid and collectable insurance or
program of self-insurance carried or maintained by The Regents.
17.4(d) The Regents will promptly notify the Licensee in writing of any claim or
suit brought against The Regents in respect of which The Regents intends to
invoke the provisions of this Article 17 (Indemnification). The Licensee will
keep The Regents informed on a current basis of its defense of any claims
pursuant to this Article 17 (Indemnification).
18. Notices
Any notice or payment required to be given to either party will be deemed to
have been properly given and to be effective (a) on the date of delivery if
delivered in person; (b) on the date of mailing if mailed by first-class
certified mail, postage paid; or (c) on the date of mailing if mailed by any
global express carrier service that requires the recipient to sign the documents
19
demonstrating the delivery of such notice of payment to the respective addresses
given below, or to another address as designated in writing by the party
changing its prior address.
In the case of the Licensee: Alsius Corp.
00000 Xxxxxx Xxxxxx Xxxx, Xxxxx 000
Xxxxxx, XX 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxxx X. Xxxxxx, Esq.
In the case of The Regents: The Regents of the University of California
Office of Sponsored Research
Box 951406, 1401 Xxxxxxxxx Building
University of California, Los Angeles
Xxx Xxxxxxx, Xxxxxxxxxx 00000-0000
Telephone: (000)000-0000
Facsimile: (000) 000-0000
Attention: Director
19. Assignability
19.1 This Agreement is binding upon and will inure to the benefit of The
Regents, their successors and assigns, but will be personal to the Licensee and
assignable by the Licensee only with the written consent of The Regents,
provided, however, that this Agreement may be assigned by Licensee pursuant to a
sale of all or substantially all of Licensee's stock or assets without any prior
approval of The Regents. Any other attempt by Licensee to assign this Agreement
is void unless Licensee obtains the prior written consent of The Regents.
20. Late Payments
20.1 In the event royalty payments, fees, or patent prosecution costs are not
received by The Regents when due, the Licensee will pay to The Regents interest
charges at a rate often percent (10%) simple interest per annum. Such interest
will be calculated from the date payment was due until actually received by The
Regents. Acceptance by The Regents of any late payment interest from the
Licensee under this Paragraph 20.1 will in no way affect the provision of
Article 21 (Waiver) herein.
20
21. Waiver
21.1 It is agreed that no waiver by either party hereto of any breach or default
of any of the covenants or agreements herein set forth will be deemed a waiver
as to any subsequent and/or similar breach or default.
22. Failure to Perform
22.1 In the event of a failure of performance due under the terms of this
Agreement and if it becomes necessary for either party to undertake legal action
against the other on account thereof, then such legal action will be conducted
in San Francisco, California, and the prevailing party xxxx be entitled to
reasonable attorney's fees in addition to costs and necessary disbursements.
23. Governing Laws
23.1 THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE
LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules that would
direct the application of the laws of another jurisdiction, but the scope and
validity of any patent or patent application will be governed by the applicable
laws of the country of such patent or patent application.
24. Government Approval or Registration
24.1 If this Agreement or any associated transaction is required by the law of
any nation to be either approved or registered with any governmental agency, the
Licensee will assume all legal obligations to do so. The Licensee will notify
The Regents if it becomes aware that this Agreement is subject to a United
States or foreign government reporting or approval requirement. The Licensee
will make all necessary filings and pay all costs including fees, penalties, and
all other out-of-pocket costs associated with such reporting or approval
process.
25. Export Control Laws
25.1 The Licensee will observe all applicable United States and foreign laws
with respect to the transfer of Patent Products and related technical data to
foreign countries, including, without limitation, the International Traffic in
Arms Regulations (ITAR) and the Export Administration Regulations.
21
26. Force Majeure
26.1 The parties to this Agreement will be excused from any performance required
hereunder if such performance is rendered impossible or unfeasible due to any
acts of God, catastrophes, or other major events beyond their reasonable
control, including, without limitation, war, riot, and insurrection; laws,
proclamations, edicts, ordinances, r regulations; strikes, look-outs, or other
serious labor disputes; and floods, fires, explosions, or other natural
disasters. However, any party to this Agreement will have the right to terminate
this Agreement upon 30 days' prior written notice if either party is unable to
fulfill its obligations under this Agreement due to any of the causes mentioned
above and such inability continues for a period of one year. Notices will be
subject to Article 18 (Notices).
27. Confidentiality
27.1 The Licensee and The Regents respectively will treat and maintain the
proprietary business, patent prosecution) software, engineering drawings,
process and technical information, and other proprietary information
(Proprietary Information") of the other party in confidence using at least the
same degree of care as that party uses to protect its own proprietary
information of a like nature for a period from the date of disclosure until five
years after the date of termination of this Agreement. This confidentiality
obligation will apply to the information defined as "Data" under the Secrecy
Agreement, and such Data will be treated as Proprietary Information hereunder.
27.2 All Proprietary Information will be labeled or marked confidential or as
otherwise similarly appropriate by the disclosing party, or if the Proprietary
Information is orally disclosed, it will be reduced to writing or some other
physically tangible form, marked and labeled as set forth above by the
disclosing party, and delivered to the receiving party within 30 days after the
oral disclosure as a record of the disclosure and the confidential nature
thereof. Notwithstanding the foregoing, the Licensee and The Regents may use and
disclose Proprietary information to its employees, agents, consultants,
contractors, and, in the case of the Licensee, its sublicensees, provided that
any such parties are bound by a like duty of confidentiality.
22
27.3 Nothing contained herein will in any way restrict or impair the right of
the Licensee or The Regents to use, disclose, or otherwise deal with any
Proprietary Information:
27.3(a) That recipient can demonstrate by written records was previously known
to it.
27.3(b) That is now, or becomes in the future, public knowledge other than
through acts or omissions of recipient.
27.3(c) That is lawfully obtained without restrictions by recipient from sources
independent of the disclosing party.
27.3(d) That is required to be disclosed to a governmental entity or agency in
connection with seeking any governmental or regulatory approval, or pursuant to
the lawful requirement or request of a governmental entity or agency.
27.3(e) That The Regents are required to disclose pursuant to the California
Public Records Act or other applicable law.
27.4 Upon termination of this Agreement, the Licensee and The Regents will
destroy or return to the disclosing party proprietary information received from
the other in its possession within 15 days following the effective date of
termination. The Licensee and The Regents will provide each ether, within 30
days following termination, with a Written notice that Proprietary Information
has been returned or destroyed, Each party may, however, retain one copy of
Proprietary Information for archival purposes in non-working files.
28. Miscellaneous
28.1 The headings of the several sections are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement. This Agreement will not be binding upon the
parties until it has been signed below on behalf of each party, in which event,
it will be effective as of the date recited on page one. No amendment or
modification hereof will be valid or binding upon the parties unless made in
writing and signed on behalf of each party.
28.2 This Agreement embodies the entire understanding of the parties and will
supersede all previous communications, representations or understandings, either
oral or written, between the parties relating to the subject matter hereof.
23
28.3 In case any of the provisions contained in this Agreement are held to be
invalid, illegal, or unenforceable in any respect, such invalidity, illegality,
or unenforceability will not affect any other provisions hereof, but this
Agreement will be construed as if such invalid or illegal or unenforceable
provisions had never been contained herein.
28.4 This Agreement has been negotiated and prepared jointly by both parties and
shall not be construed for or against any party but shall be given a fair and
reasonable construction in accordance with the intention of the parties.
In witness whereof both The Regents and the Licensee have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, on the date and year hereinafter written.
ALSIUS CORP. THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
By /s/ Xxxxxxx Xxxxxxx By /s/ Xxxxxxxx Xxxxxxx
---------------------------------- -------------------------------------
(Signature) (Signature)
Name Xxxxxxx X. Xxxxxxx Name: Xxxxxxxx Xxxxxxx
(Please Print)
Title President & CEO Title: Director, Office of Sponsored
Research
Date 2/8/00 Date 11/16/99
24
First Amendment
To
Exclusive License Agreement No.0000-00-0000
For Indwelling Heat Exchange Catheter
This Amendment is made and is effective this 25 day of October, 2000 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 00000 Xxxxxxxx
Xxxxxxxxx, Xxxxx 0000, Xxx Xxxxxxx, Xxxxxxxxxx 00000 and Alsius Corporation
("Licensee"), a California corporation having a principal place of business at
00000 Xxxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxx, Xxxxxxxxxx 00000 and amends License
Agreement No, 2000- 04-0437 between The Regents and Alsius in accordance with
the terms and conditions of this Amendment.
The parties agree as follows:
1. Section 1.1 under Definitions shall be amended to add at the end of the
paragraph the following:
"Patent applications that fall under the definition of Patent Rights as
defined in Section 1 1 will be automatically be incorporated in arid added
to Appendix A and made a part of this agreement."
2. Section 6.1 under Progress and Royalty Reports shall be amended to read:
"Beginning October 30, 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."
All other terms and conditions remain the same.
ALSIUS CORPORATION THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxx Xxxxxxx
--------------------------------- ------------------------------------
Name: Xxxxx X. Xxxxxx Name: Xxxxx Xxxxxxx
Title: Sr. I.P. Counsel Title: Asst. Director
Date: 10/25/00 Date: 10-25-00
APPENDIX A
Exclusive License Agreement No.0000-00-0000
For Indwelling Heat Exchange Catheter
1. Patent Application Serial No, 091133,813 filed August 13, 1998 entitled
indwelling Heat Exchange Catheter and Method of Using Same," (UCLA Case No.
LA99-501-2).
2. Patent Application Serial No. 09/503,014 filed February 11, 2000 entitled
"Indwelling Heat Exchange Catheter and Method of Using Same11' (UCLA Case
No. LA99501-3).
3. Patent Application Serial No. 09/546,814 filed April 11, 2000 entitled
"Indwelling Heat Exchange Catheter and Method of Using Same,1' (UCLA Case
No, LA99-501-4).
10/25/00
