Exhibit 10.14
Exclusive License Agreement
between
The Regents of the University of California
and
Collateral Therapeutics, Inc.
for
Gene Therapy for Congestive Heart Failure
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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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U.C. AGREEMENT
CONTROL NUMBER
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Table of Contents
Recitals.................................................................... 1
1. Definitions........................................................... 4
2. Grant................................................................. 7
3. License Issue Fee..................................................... 9
4. Royalties............................................................. 10
5. Due Diligence......................................................... 14
6. Progress and Royalty Reports.......................................... 16
7. Books and Records..................................................... 18
8. Life of the Agreement................................................. 19
9. Termination by The Regents............................................ 20
10. Termination by Licensee............................................... 21
11. Disposition of Patent Products on Hand Upon Termination............... 21
12. Use of Names and Trademarks........................................... 22
13. Limited Warranty...................................................... 23
14. Patent Prosecution and Maintenance.................................... 24
15. Patent Marking........................................................ 28
16. Patent Infringement................................................... 28
17. Indemnification....................................................... 30
18. Notices............................................................... 32
19. Assignability......................................................... 33
20. Late Payments......................................................... 34
21. Waiver................................................................ 34
22. Failure to Perform.................................................... 34
23. Governing Laws........................................................ 35
24. Government approval or Registration................................... 35
25. Export Control Laws................................................... 36
26. Force Majeure......................................................... 36
27. Confidentiality....................................................... 37
28. Miscellaneous......................................................... 39
***
Revised: 7/13/95 (SH)
Draft date: January 14, 1997
Exclusive License Agreement
for
Gene Therapy for Congestive Heart Failure
This license agreement ("Agreement") is effective this 22nd day of Jan.,
1997, by and between The Regents of the University of California ("The
Regents"), a California corporation, having its statewide administrative offices
at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ and Collateral
Therapeutics, Inc., ("Licensee"), a California corporation, having a principal
place of business at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
Recitals
Whereas, certain inventions, relating to "Gene Therapy for Congestive
Heart Failure" ("Invention"), useful for enhancing myocardial B-adrenergic
responsiveness in mammalian hearts using gene therapy, were made at the
University of California, San Diego ("UCSD"), are described and claimed in a
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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U.C. AGREEMENT
CONTROL NUMBER
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U.S. Patent Application Serial No. *** naming *** H. ▇▇▇▇ ▇▇▇▇▇▇▇ *** and ***
as co-inventors, and are identified in the below defined Patent Rights;
Whereas, it is the intention of the Licensee to investigate the use of the
gene therapy method claimed in U.S. Patent Application Serial No. *** and
previously licensed to Licensee in the agreement entitled "Angiogenesis Gene
Therapy," executed on September 29, 1995, in the development of Patent Products
licensed herein;
Whereas, Licensee entered into a Letter of Intent ("Letter of Intent"),
having U.C. Agreement Control No. *** effective *** that provided the Licensee
with a time-limited exclusive right to negotiate for a license to the Patent
Rights;
Whereas, under 35 USC 200-212, The Regents may elect to retain title to
any invention (including the Invention) made by it, in whole or in part, under
U.S. Government funding;
Whereas, if The Regents elects to retain title to the Invention, then the
law requires that The Regents grant to the U.S. Government a nontransferable,
paid-up, nonexclusive, irrevocable license to use the Invention by or on behalf
of the U.S. Government throughout the world;
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Confidential Treatment and filed separately with the Commission.
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Whereas, any patent application claiming an invention made by H. ▇▇▇▇
▇▇▇▇▇▇▇, M.D. is subject to assignment to the *** absent a release to ***
from the ***;
Whereas, 37 CFR ss.501.6(a)(2) allows the *** to release the Invention
to ▇▇. ▇▇▇▇▇▇▇, under certain conditions;
Whereas, ▇▇. ▇▇▇▇▇▇▇, an employee of The Regents, is under obligation to
assign to The Regents the rights in the Invention that were released to him
by the ***;
Whereas, ▇▇. ▇▇▇▇▇▇▇ assigned to The Regents title to the Invention,
which was released to him from the *** and granted the required licenses to
the U.S. Government;
Whereas, Licensee is a "small entity" as defined in 37 CFR Section 1.9
and a "small-business concern" defined at 15 U.S.C. ss.632;
Whereas, both parties recognize that royalties due under this Agreement
will be paid on issued patents and pending patent applications that are being
prosecuted diligently and in good faith;
Whereas, Licensee requested an exclusive license to the Patent Rights
from The Regents; and
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Confidential Treatment and filed separately with the Commission.
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Whereas, The Regents wish to grant an exclusive license to the Patent
Rights to Licensee so that products and other benefits derived from the
Invention can be enjoyed by the general public.
- - oo O oo - -
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 U.S. patents and patent applications and
foreign patents and patent applications assigned to The Regents, and in the
case of foreign patents and patent applications those requested under
Paragraph 14.4 herein, including any reissues, extensions, substitutions,
continuations, divisions, and continuations-in-part applications (only to the
extent, however, that claims in the continuations-in-part applications are
entitled to the priority filing date of the parent patent application) based
on and including any subject matter claimed in or described according to the
requirements of 35 USC Section 112 in U.S. Patent Application Serial
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Number *** entitled *** filed *** by Dr. H. ▇▇▇▇ ▇▇▇▇▇▇▇, et al. and
assigned to The Regents.
1.2 "Patent Products" means:
1.2.1 any kit, composition of matter, material, or product;
1.2.2 any kit, composition of matter, material, or product to be
used in a manner requiring the performance of the Patent
Method; or
1.2.3 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 fall within the
scope of (1 ) an unexpired claim of a patent under Patent Rights in that
country or (2) a pending claim of a pending patent application that is being
prosecuted diligently and in good faith in that country, were it issued as a
application is pending. This definition of Patent Products also includes a
service either used by Licensee or provided by Licensee to its customers when
such service requires the practice of the Patent Method.
1.3 "Patent Method" means any process or method, the use or practice of
which in a country would fall within the scope of (1) an unexpired
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claim of a patent under Patent Rights in that country or (2) a pending claim of
a pending application that is being prosecuted diligently and in good faith in
that country, were it issued as a claim in a patent under Patent Rights in that
country in which such application is pending.
1.4 "Net Sales" means the gross invoice prices from the sale of Patent
Products by 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 to 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; and (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.
1.5 "Affiliate(s)" of Licensee means any entity which, directly or
indirectly, controls Licensee, is controlled by Licensee, or is under common
control with Licensee ("control" for these purposes being defined as the
actual, present capacity to elect a majority of the directors of such
affiliate,
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or if not, the capacity to elect the members that control fifty percent (50%)
of the outstanding stock or other 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 "Affiliate" will include
any company in which Licensee will own or control, directly or indirectly,
the maximum percentage of such outstanding stock or voting rights permitted
by local law. Each reference to Licensee herein will be meant to include its
Affiliates.
1.6 "Joint Venture" means any separate entity established pursuant to
an agreement between a third party and Licensee to constitute a vehicle for
commercializing Patent Products, in which the separate entity manufactures,
uses, purchases, sells, or acquires Patent Products from Licensee. Each
reference to Licensee herein will be meant to include its Joint Venture(s).
2. Grant
2.1 Subject to the terms of this Agreement, subject to the licenses
granted to the U.S. Government as set forth in the Recitals above, and
subject to the provisions of Section 2.5 below, The Regents hereby grants to
Licensee exclusive licenses under Patent Rights to make, use, sell, offer for
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sale, and import Patent Products and to practice the Patent Method where
Patent Rights exist.
2.2 The Regents also grants to Licensee the exclusive right to issue
sublicenses to third parties to make, use, sell, offer for sale, and import
Patent Products and to practice the Patent Method, provided 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 U.S. Government,
including 35 USC Sections 200-212 and the implementing regulations),
including the payment of royalties in Article 4. (Royalties) that are
contained in this Agreement.
2.3 Licensee will notify The Regents of each sublicense granted
hereunder and provide The Regents with a copy of each sublicense. Licensee
will collect and pay all royalties due The Regents as set forth in Paragraph
4.1 below (and guarantee all such payments due from sublicensees). Licensee
will require sublicensees to provide it with progress and royalty reports in
accordance with the provisions herein, and Licensee will collect and deliver
to The Regents all such reports due from sublicensees.
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2.4 If this Agreement is terminated for any reason or the exclusive
licenses are reduced to nonexclusive licenses in accordance with Paragraph
5.4, then any or all sublicenses will be assigned to The Regents, provided
that The Regents will not be bound by any duties or obligations contained in
any sublicense that extend beyond the duties and obligations of The Regents
in this Agreement.
2.5 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 Patent
Product(s), Patent Method(s), and associated technology solely for
educational and noncommercial research purposes.
3. License Issue Fee
3.1 As partial consideration for all the rights and licenses granted to
Licensee, Licensee will pay to The Regents a license issue fee of Six Hundred
and Fifty Thousand Dollars ($650,000) according to the following schedule:
3.1.1 One Hundred Thousand Dollars ($100,000) within thirty (30)
days after the execution of this Agreement by both parties;
3.1.2 *** on or before *** ;
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Confidential Treatment and filed separately with the Commission.
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3.1.3 *** on or before *** ;
3.1.4 *** on or before *** ; and
3.1.5 *** on or before ***.
3.2 The fees set forth in Paragraph 3.1 above are non-refundable,
non-creditable, and not an advance against royalties.
4. Royalties
4.1 As further consideration for all the rights and licenses granted to
Licensee, Licensee also will pay to The Regents an earned royalty at the rate of
*** based on the Net Sales of Patent Products. In the event Patent Products also
employ the invention claimed in U.S. Patent Application Serial No. *** the
Licensee will pay to The Regents the royalty rate specified in the agreement
executed on September 29, 1995 covering such U.S. Patent Application Serial
No. *** in addition to the royalty rate specified herein.
4.2 Paragraphs 1.1, 1.2, and 1.3 define Patent Rights, Patent Product, and
Patent Method so that royalties will be payable only on Patent Products covered
by either a pending patent application that is being prosecuted diligently and
in good faith in a relevant country or by an issued
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patent in a relevant country. Earned royalties will accrue in each country for
the duration of any issued patent within 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 for the purpose of patient administration or for
purposes other than clinical trials. Licensee, its Affiliates, Joint Ventures,
and sublicensees will not use Patent Products or Patent Methods for
administration to patients in any business of the Licensee, or of its
Affiliates, Joint Ventures, and sublicensees without payment of applicable
royalty on Net Sales to be calculated on retail sales prices as if the sales
transaction had occurred at arm's-length to an unrelated third party.
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
November 30 for the calendar quarter ending September 30
Each such payment will be for royalties which accrued up to the most recently
completed calendar quarter of Licensee.
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4.4 Beginning in the year 2004, Licensee will pay to The Regents a minimum
annual royalty in the amounts and at the times set forth below:
2004 - $ ***
2005 - $ ***
2006 - $ ***
2007 - $ ***
2008 - $ ***
In each succeeding calendar year after the year 2008 Licensee will pay a
minimum annual royalty of Seven Hundred and Fifty Thousand ($750,000) for the
life of this Agreement. Each minimum annual royalty payment must be paid to
The Regents by February 28 of each year following the calendar year in which
royalties accrued. Royalties paid during the prior calendar year will be
credited against the minimum annual royalty payment due and owing for the
prior calendar year.
4.5 All monies due The Regents will be payable in United States 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
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funds. The exchange rate will be that rate quoted in the Wall Street Journal on
the last business day of the reporting period.
4.6 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). Licensee will
be responsible for all bank transfer charges.
4.7 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 Licensee with respect to any country where a Patent
Product is sold or distributed, 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.
4.8 In the event that any patent or any claim thereof included within the
Patent Rights is held invalid or unenforceable 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 of claim or any
claim patentably indistinct therefrom will cease as of the date of such final
decision. Licensee will not, however, be relieved from paying any
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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.
4.9 No royalties will be collected or paid hereunder to The Regents on
Patent Products sold to the account of the U.S. Government. Licensee and its
sublicensee will reduce the amount charged for Patent Products distributed to
the United States Government by an amount equal to the royalty for such Patent
Products otherwise due The Regents as provided herein.
5. Due Diligence
5.1 Licensee, upon execution of this Agreement, will diligently proceed
with the development, manufacture and sale of Patent Products. In this regard,
The Regents acknowledges that the technology covered by this Agreement has only
recently been invented and that substantial additional effort, expense and time,
as well as regulatory approval, will be required before manufacture and sales of
any Patent Products will be possible. Meeting the requirements of Section 5.3
below shall be deemed to satisfy the due diligence requirements of this Article
5.
5.2 Licensee will be entitled to exercise prudent and reasonable business
judgment in the manner in which it meets its due diligence
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obligations hereunder, including under Section 5.3 below. In no case, however,
will Licensee be relieved of its obligations to meet each of the due diligence
provisions of Paragraph 5.3 below.
5.3 If Licensee is unable to perform any of the following:
5.3.1 file an Investigational New Drug application with the U.S.
Food and Drug Administration on or before *** *** ;
5.3.2 begin Phase I Clinical Trials in the United States for Patent
Products on or before *** ;
5.3.3 enter Pivotal Trials (a combination of Phase II and Phase III
Clinical Trials) in the United States for said Patent Products
on or before *** ;
5.3.4 file for marketing approval in the United States for said
Patent Products on or before *** ;
5.3.5 market Patent Products in the United States within *** after
receiving marketing approval of such Patent Products from the
U.S. Food and Drug Administration; and
5.3.6 diligently and earnestly fill the market demand for Patent
Products following commencement of marketing at any time
during the exclusive period of this Agreement;
then The Regents will have the right and option to terminate this Agreement or
reduce the exclusive licenses granted to Licensee to non-exclusive licenses in
accordance with Paragraph 5.4 hereof. The exercise of this right
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and option by The Regents supersedes the rights granted in Article 2. (Grant).
5.4 To exercise either the right to terminate this Agreement or reduce
the exclusive licenses granted to Licensee to non-exclusive licenses for lack
of any diligence requirement specified in this Article 5. (Due Diligence),
The Regents will give Licensee written notice of the deficiency. Licensee
thereafter has 60 (sixty) days to cure the deficiency. Licensee shall be
entitled to a one-time extension of each of the dates set forth in
Subparagraphs 5.3.1 through 5.3.4 (which have not been met) by one (1)
additional year to cure the deficiency upon payment of One Hundred Thousand
Dollars ($100,000) to The Regents, provided that such payment is received by
The Regents within sixty (60) days of receipt of written notice by The
Regents of Licensee's deficiency. The One Hundred Thousand Dollar ($100,000)
payment has the effect of extending the subject date and all subsequent dates
by one (1) year. If The Regents has not received the One Hundred Thousand
Dollar ($100,000) payment by the end of the sixty (60)-day period or written
tangible evidence satisfactory to The Regents that the deficiency has been
cured by the end of the sixty (60)-day period then The Regents may, at its
option, terminate this Agreement or reduce the exclusive
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licenses granted to Licensee to non-exclusive licenses by giving written notice
to Licensee in accordance with Article 18. (Notices).
6. Progress and Royalty Reports
6.1 Beginning August 31, 1997, and semi-annually thereafter, Licensee will
submit to The Regents a progress report covering activities by Licensee related
to the development, including clinical trials and testing, of all Patent
Products and the obtaining of the governmental approvals necessary for
marketing. 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:
o summary of work completed;
o summary of work in progress;
o current schedule of anticipated events or milestones specified
in Paragraph 5.3 and the dates when said milestones have been
met or will be met, as of the time of the report;
o market introduction date of Patent Products; and
o activities of sublicensees, if any.
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6.3 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 where the Licensee has sought marketing approval.
6.4 After the first commercial sale of a Patent Product, 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
Licensee (October through December, January through March, April through June,
and July through September) and will show:
6.4.1 the gross sales and Net Sales of Patent Products sold by
Licensee and reported to Licensee as sold by its sublicensees
during the most recently completed calendar quarter;
6.4.2 the number of Patent Products sold or distributed by Licensee
and reported to Licensee as sold or distributed by its
sublicensees;
6.4.3 the royalties, in U.S. dollars, payable hereunder with respect
to Net Sales; and
6.4.4 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.
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7. Books and Records
7.1 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 four (4) 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 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%) of the total royalties due for any year
is discovered, then the fees and expenses of these representatives will be borne
by 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,
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or until the last patent application licensed under this Agreement is abandoned.
8.2 Any termination of this Agreement will not affect the rights and
obligations set forth in the following Articles:
Article 3 License Issue Fee
Article 7 Books and Records
Article 11 Disposition of Patent Products on Hand Upon Termination
Article 12 Use of Names and Trademarks
Paragraph 14.6 Patent Prosecution and Maintenance
Article 17 Indemnification
Article 22 Failure to Perform
Article 27 Confidentiality
9. Termination by The Regents
9.1 If Licensee should violate or fail to perform any material term or
covenant of this Agreement, then The Regents may give written notice of such
default ("Notice of Default") to Licensee. If Licensee should fail to repair
such default within sixty (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
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Licensee. If a Notice of Termination is sent to Licensee, this Agreement will
automatically terminate on the date such notice takes effect. Such termination
will not relieve Licensee of its obligation to pay any royalty or 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 Licensee
10.1 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 sixty (60) days after the
effective date thereof.
10.2 Any termination pursuant to the above paragraph will not relieve The
Regents or Licensee of any obligation or liability accrued hereunder prior to
such termination or rescind anything done by The Regents or 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 or Licensee arising under this Agreement prior to such
termination.
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11. Disposition of Patent Products on Hand Upon Termination
11.1 Upon termination of this Agreement, Licensee will have the privilege
of disposing of all previously made or partially made Patent Products, but no
more, within a period of one hundred twenty (120) days, provided, however, that
the sale of such Patent Products will be subject to the terms of this Agreement
including, but not limited to the payment of fees and reimbursement for patent
costs and the payment of royalties based on the Net Sales of Patent Products at
the rates and at the times provided herein and the rendering of reports in
connection therewith.
12. Use of Names and Trademarks
12.1 Nothing contained in this Agreement will be construed as conferring
any right to use in advertising, publicity, or other promotional activities any
name, trade name, trademark, or other designation of either party hereto by the
other (including contraction, abbreviation or simulation of any of the
foregoing). Unless required by law, the use by Licensee of the name "The Regents
of the University of California" or the name of any campus of the University of
California for use in advertising, publicity, or other promotional activities is
expressly prohibited.
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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
request that such terms will be kept in confidence in accordance with the
provisions of Article 27. (Confidentiality) and not be disclosed 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 Licensee, except where The Regents is required
to release such information under either the California Public Records Act or
other applicable law.
13. Limited Warranty
13.1 The Regents warrants to Licensee that it has the lawful right to
grant this license, and that it has not granted any rights or licenses to Patent
Rights, other than to the U.S. Government, in derogation of this Agreement.
13.2 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, EXPRESSED OR IMPLIED.
THE REGENTS MAKES NO
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REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT PRODUCTS, OR PATENT METHOD
WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
13.3 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 METHOD, OR PATENT PRODUCTS.
13.4 Nothing in this Agreement will be construed as:
13.4.1 a warranty or representation by The Regents as to the
validity, enforceability, or scope of any Patent Rights;
or
13.4.2 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; or
13.4.3 an obligation to bring or prosecute actions or suits
against third parties for patent infringement except as
provided in Article 16. (Patent Infringement); or
13.4.4 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; or
13.4.5 an obligation to furnish any know-how not provided in
Patent Rights.
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14. Patent Prosecution and Maintenance
14.1 The Regents will diligently prosecute and maintain the United States
and foreign patents comprising Patent Rights using counsel of its choice. The
Regents will promptly provide Licensee with copies of all relevant documentation
so that Licensee 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 Licensee has not commented upon such documentation prior to the initial
deadline for filing a response with the relevant government patent office, or
The Regents must act to preserve Patent Rights, The Regents will be free to
respond appropriately without consideration of comments by Licensee, if any.
Both parties hereto will keep this documentation in confidence in accordance
with the provisions of Article 27. (Confidentiality) herein. The Regents'
counsel will take instructions only from The Regents.
14.2 The Regents will use all reasonable efforts to amend any patent
application to include claims requested by Licensee and required to protect the
Patent Products contemplated to be sold or Patent Method to be practiced under
this Agreement.
25
14.3 The Regents and Licensee will cooperate in applying for an extension
of the term of any patent included within Patent Rights, if appropriate, under
the Drug Price Competition and Patent Term Restoration Act of 1984. Licensee
will prepare all such documents, and The Regents will execute such documents and
will take such additional action as Licensee may reasonably request in
connection therewith.
14.4 The Regents will, at the request of Licensee, file, prosecute, and
maintain patent applications and patents covered by Patent Rights in foreign
countries if available. Licensee must notify The Regents within nine (9) months
of the filing of the corresponding United States application of its decision to
request The Regents to file foreign counterpart patent applications. This notice
concerning foreign filing must be in writing and must identify the countries
desired. The absence of such a notice from Licensee to The Regents within the
nine (9)-month period will be considered an election by Licensee not to request
The Regents to secure foreign patent rights on behalf of Licensee. The Regents
will have the right to file patent applications at its 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 unless Licensee agrees in writing to pay all costs
associated with any such patent
26
application(s) and provided the rights of said patent application(s) are
available at the time Licensee agrees to pay the associated costs.
14.5 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 will be borne by Licensee. This includes all patent
preparation and prosecution costs 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 Licensee. Licensee will reimburse The Regents for all
costs and charges within thirty (30) days following receipt of an itemized
invoice from The Regents for same.
14.6 The obligation of Licensee to underwrite and to pay patent
preparation, filing, prosecution, maintenance, and related costs will continue
for such costs as may be incurred during the three (3)-month period after
receipt by either party of a Notice of Termination for all non-cancelable
obligations made prior to the receipt of said Notice of Termination. Licensee
will reimburse The Regents for all patent costs incurred during the term of the
Agreement and for three (3) months thereafter whether or not invoices
27
for such costs are received during the three (3)-month period after receipt of a
Notice of Termination. Licensee may with respect to any particular patent
application or patent terminate its obligations to the patent application or
patent in any or all designated countries upon three months written notice to
The Regents. The Regents may continue prosecution and/or maintenance of such
application(s) or patent(s) at its sole discretion and expense, provided,
however, that Licensee will have no further right or licenses thereunder.
14.7 Licensee will have a continuing responsibility to keep The Regents
informed of its large/small entity status (as defined by the United States
Patent and Trademark Office) of itself and its sublicensees.
15. Patent Marking
15.1 Licensee will ▇▇▇▇ 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 Licensee learns of the substantial infringement of
any patent licensed under this Agreement, Licensee will call the attention of
The Regents thereto in writing and will provide The Regents with
28
reasonable evidence of such infringement. Both parties to this Agreement
acknowledge that during the period and in a jurisdiction where Licensee has
exclusive rights under this Agreement, neither will notify a third party of the
infringement of any of Patent Rights without first obtaining consent of the
other party, which consent will not be unreasonably withheld. Both parties will
use their best efforts in cooperation with each other to terminate such
infringement without litigation.
16.2 Licensee may request that The Regents take legal action against the
infringement of Patent Rights. Such request must be made in writing and must
include reasonable evidence of such infringement and damages to Licensee. If the
infringing activity has not been abated within ninety (90) days following the
effective date of such request, The Regents will have the right to elect to:
16.2.1 commence suit on its own account; or
16.2.2 refuse to participate in such suit
and The Regents will give notice of its election in writing to Licensee by the
end of the one hundredth (100th) day after receiving notice of such request from
Licensee. Licensee may thereafter bring suit for patent infringement if and only
if The Regents elects not to commence suit and if the infringement occurred
during the period and in a jurisdiction where Licensee had exclusive
29
rights under this Agreement. However, in the event Licensee elects to bring suit
in accordance with this Paragraph, The Regents may thereafter join such suit at
its own expense, but the Licensee will control the lawsuit.
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 recovered thereby will belong
to such party, provided, however, that legal action brought jointly by The
Regents and 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 attorney's 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,
provided, however, that The Regents may be represented by counsel of its choice
in any suit brought by Licensee.
30
17. Indemnification
17.1 Licensee will (and will 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 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.
17.2 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)
At the initiation of clinical trials, Comprehensive or Commercial Form
General Liability Insurance (contractual liability included) with limits as
follows up to and until Licensee enters Phase III Clinical Trials:
(a) Each Occurrence.................................... $3,000,000
(b) Products/Completed Operations Aggregate............ $3,000,000
(c) Personal and Advertising Injury.................... $3,000,000
(d) General Aggregate (commercial form only)........... $3,000,000
31
Comprehensive or Commercial Form General Liability Insurance (contractual
liability included) with limits as follows after Licensee enters Phase III
Clinical Trials:
(a) Each Occurrence.................................... $5,000,000
(b) Products/Completed Operations Aggregate............ $5,000,000
(c) Personal and Advertising Injury.................... $5,000,000
(d) General Aggregate (commercial form only)........... $5,000,000
It should be expressly understood, however, that the coverages and limits
referred to under the above will not in any way limit the liability of Licensee.
Licensee will furnish The Regents with certificates of insurance evidencing
compliance with all requirements. Such certificates will:
(a) Provide for thirty (30)-day advance written notice to The
Regents of any modification;
(b) Indicate that The Regents has been endorsed as an additional
Insured under the coverages referred to under the above; and
(c) Include a provision that the coverages will be primary and
will not participate with nor will be excess over any valid
and collectable insurance or program of self-insurance carried
or maintained by The Regents.
17.3 The Regents will immediately notify 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). Licensee will keep
The Regents informed as appropriate and necessary on a
32
current basis of its defense of any claims pursuant to this Article 17.
(Indemnification).
18. Notices
18.1 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 or (b) five days after mailing if mailed by
first-- class certified mail, postage paid, to the respective addresses given
below, or to another address as it may designate by written notice given to the
other party.
In the case of Licensee: COLLATERAL THERAPEUTICS, INC.
▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇ ▇▇▇▇▇, Ph.D.
In the case of The Regents: THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
33
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
Executive Director
Research Administration and
Technology Transfer
Referring to: ***
19. Assignability
19.1 This Agreement is binding upon and will inure to the benefit of The
Regents, its successors and assigns, but will be personal to Licensee and
assignable by Licensee only with the written consent of The Regents, which
consent shall not be unreasonably withheld.
20. Late Payments
20.1 In the event royalty payments or fees or patent prosecution costs are
not received by The Regents when due, Licensee will pay to The Regents interest
charges at a rate of *** 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 Licensee under this
Paragraph 20 will in no way affect the provision of Article 21. (Waiver) herein.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
34
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 the prevailing party will 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.
35
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, Licensee will assume all legal obligations to do so. 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. 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 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.
26. Force Majeure
26.1 The parties to this Agreement will be excused from any performance
required hereunder if such performance is rendered impossible
36
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, or regulations; strikes,
lock-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 thirty (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 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 of the
other party ("Proprietary Information") 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 (5) years
after the date of termination of this Agreement.
27.2 Proprietary Information will be labeled or marked confidential or as
otherwise similarly appropriate by the disclosing party, or if the
37
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 thirty (30)
days after the oral disclosure as a record of the disclosure and the
confidential nature thereof. Notwithstanding the foregoing, Licensee and The
Regents may use and disclose Proprietary Information to its employees, agents,
consultants, and contractors having a need to know the Proprietary Information
and, in the case of Licensee, its sublicensees, provided that any such parties
are bound by a like duty of confidentiality.
27.3 Nothing contained herein will in any way restrict or impair the right
of Licensee or The Regents to use, disclose, or otherwise deal with any
Proprietary Information:
27.3.1 that recipient can demonstrate by written records was
previously known to it;
27.3.2 that is now, or becomes in the future, public knowledge
other than through acts or omissions of recipient;
27.3.3 that is lawfully obtained without restrictions by
recipient from sources independent of the disclosing
party;
27.3.4 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;
38
27.3.5 that is furnished to a third party by the recipient with
a need to know and with similar confidentiality
restrictions imposed on such third party, as evidenced
in writing, or
27.3.6 that The Regents is required to disclose pursuant to the
California Public Records Act or other applicable law.
27.4 Upon termination of this Agreement, Licensee and The Regents will
destroy or return to the disclosing party proprietary information received from
the other in its possession within fifteen (15) days following the effective
date of termination. Licensee and The Regents will provide each other, within
thirty (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 nonworking 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.
28.2 The licenses and any sublicenses granted hereunder will be subject to
any legal obligations to the U.S. Government including those set forth in 35 U.
S. C. 200-212 and applicable governmental implementing
39
regulations. Because this Agreement grants the exclusive right to use or sell
the Patent Products in the United States, Licensee acknowledges that Patent
Products will be manufactured substantially in the United States as required
under 35 USC Section 204.
28.3 The manufacture of Patent Products will be in accordance with any
applicable government importation laws and regulations of a particular country
on Patent Products made outside the particular country in which such Patent
Products are to be used or sold.
28.4 Licensee will obtain all necessary governmental approvals in each
country where it intends to sell or manufacture and use Patent Products or
permit others to manufacture, use, or sell Patent Products.
28.5 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.
28.6 No amendment or modification hereof will be valid or binding upon the
parties unless made in writing and signed on behalf of each party,
28.7 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
40
subject matter hereof. The Letter of Intent specified in the Recitals in this
Agreement is hereby terminated.
28.8 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.
The Regents and Licensee execute this Agreement in duplicate originals by
their respective, authorized officers on the date indicated.
Collateral Therapeutics, Inc. The Regents of the University of
California
By /s/ ▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D. By /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
------------------------------- --------------------------------
(Signature) (Signature)
Name ▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D. Name ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
-----------------------------
(Please Print)
Title President and C.E.O. Title Executive Director
---------------------------- Research Administration and
Technology Transfer
Date January 20, 1997 Date January 22, 1997
------------------------------ ------------------------------
Approved as to legal form:
By /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇ 1/14/97
------------------------------- ------------------------------
(Date)
▇▇▇▇▇ ▇. ▇▇▇▇▇, Associate President Counsel
Office of Technology Transfer
University of California
41