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Title: |
Exclusive License Agreement |
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Entities: |
Dynavax Technologies Corp.; Regents of the University of California; University of California, San Diego |
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Date: |
2003 |
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59KB total |
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$36 |
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ID: |
#302862 |
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EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
DYNAVAX TECHNOLOGIES CORPORATION
FOR
COMPOUNDS FOR INHIBITION OF CERAMIDE-MEDIATED SIGNAL TRANSDUCTION
AND
NEW ANTI-INFLAMMATORY INHIBITORS: INHIBITORS OF STRESS ACTIVATED PROTEIN KINASE
PATHWAYS
UC CASE NO. 94-029-2, 94-029-3, 94-029-4
{PAGE}
TABLE OF CONTENTS
{TABLE}
{CAPTION}
ARTICLE NO. TITLE PAGE
{S} {C} {C}
BACKGROUND....................................................................... 1
1. DEFINITIONS..................................................... 2
2. LIFE OF PATENT EXCLUSIVE GRANT.................................. 4
3. SUBLICENSES..................................................... 4
4. PAYMENT TERMS................................................... 5
5. LICENSE-ISSUE FEE............................................... 6
6. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES................... 6
7. ADDITIONAL PAYMENTS............................................. 7
8. DUE DILIGENCE................................................... 7
9. PROGRESS AND ROYALTY REPORTS.................................... 8
10. BOOKS AND RECORDS............................................... 9
11. LIFE OF THE AGREEMENT........................................... 9
12. TERMINATION BY THE REGENTS...................................... 10
13. TERMINATION BY LICENSEE......................................... 10
14. DISPOSITION OF LICENSED PRODUCT ON HAND UPON TERMINATION........ 10
15. USE OF NAMES AND TRADEMARKS..................................... 11
16. LIMITED WARRANTY................................................ 11
17. PATENT PROSECUTION AND MAINTENANCE.............................. 12
18. PATENT MARKING.................................................. 13
19. PATENT INFRINGEMENT............................................. 13
20. INDEMNIFICATION................................................. 15
21. NOTICES......................................................... 16
22. ASSIGNABILITY................................................... 16
23. NO WAIVER....................................................... 16
24. FAILURE TO PERFORM.............................................. 16
25. GOVERNING LAWS.................................................. 17
26. PREFERENCE FOR U.S. INDUSTRY.................................... 17
27. GOVERNMENT APPROVAL OR REGISTRATION............................. 17
28. EXPORT CONTROL LAWS............................................. 17
29. SECRECY......................................................... 17
30. MISCELLANEOUS................................................... 19
{/TABLE}
{PAGE}
UC Case No. 94-029
EXCLUSIVE LICENSE AGREEMENT
For
Compounds for Inhibition of Ceramide-Mediated Signal Transduction
And
New Anti-Inflammatory Inhibitors: Inhibitors of Stress Activated Protein
Kinase Pathways
This License Agreement (the "Agreement") is made effective this 2nd day
of October, 1998 (the "Effective Date"), between THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA, a California corporation, having its statewide administrative
offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200
("The Regents"), and Dynavax Technologies Corporation, a California corporation,
having a principal place of business at 717 Potter Street, Suite 100, Berkeley,
CA 94710 (the "Licensee").
BACKGROUND
A. Certain inventions, generally characterized as Compounds for
Inhibition of Ceramide-Mediated Signal Transduction and New Anti-Inflammatory
Inhibitors: Inhibitors of Stress Activated Protein Kinase Pathways for certain
patent applications covered by UC Case No. 94-029 (collectively the
"Invention"), were made in the course of research at the University of
California, San Diego by Drs. Dennis A. Carson, Howard Cottam, and D. Bruce
Wasson, and are covered by Regents' Patent Rights as defined below.
B. The development of the Invention was sponsored in part by
National Institutes of Health and, as a consequence, this license is subject to
overriding obligations to the United States ("U.S.") Federal Government under 35
U.S.C. Sections 200-212 and applicable regulations.
C. Licensee has evaluated the Invention under a Secrecy Agreement
with The Regents (U.C. Control No. 98-20-0041) dated July 23, 1997.
1
{PAGE}
D. Licensee and The Regents have executed a Letter of Intent
(U.C. Control No. 98-30-0042) dated July 11, 1997.
E. Licensee wishes to obtain rights from The Regents for the
exclusive commercial development, use and sale of products from the Invention,
and The Regents is willing to grant those rights so that the Invention may be
developed to its fullest and the benefits enjoyed by the general public.
F. Licensee is a "small business firm" as defined in 15
U.S.C. Section 632.
G. Both parties recognize and agree that royalties due under this
Agreement on products and methods will be paid by Licensee on both pending
patent applications and issued patents.
H. The Regents and The Licensee understand and agree that The
Invention licensed hereunder embodies significant know-how and, accordingly,
royalties due under this Agreement will be paid on products developed through
the use of Technology Rights and The Licensee is willing to pay such royalties
in exchange for the Technology Rights granted by, and used under, this license,
regardless of whether or not some or all of the Technology Rights may have been
published or may become published.
I. The Regents gratefully acknowledge the gift of [***].
--00000--
In view of the foregoing, the parties agree:
1. DEFINITIONS
1.1 "Affiliate" means any corporation or other business entity in
which Licensee owns or controls, directly or indirectly, at least fifty percent
(50%) of the outstanding stock or other voting rights entitled to elect
directors or in which Licensee is owned or controlled directly or indirectly by
at least fifty percent (50%) of the outstanding stock or other voting rights
entitled to elect directors; but in any country where the local law does not
permit foreign equity participation of at least fifty percent (50%), then an
"Affiliate" includes any company in which Licensee owns or controls, or is owned
or controlled by, directly or indirectly, the maximum percentage of outstanding
stock or voting rights permitted by local law.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
2
{PAGE}
1.2 "Licensed Method" means any method that is covered by Regents'
Technology Rights or Regents' Patent Rights, or the use of which would
constitute, but for the license granted to Licensee under this Agreement, an
infringement of any pending or issued claim within Regents' Patent Rights.
1.3 "Licensed Product" means any material that is either covered
by Regents' Technology Rights, or Regents' Patent Rights, that is produced by
the Licensed Method or that the use of which would constitute, but for the
license granted to Licensee under this Agreement, an infringement of any pending
or issued claim within Regents' Patent Rights, or a misuse or misappropriation
of Regents' Technology Rights.
1.4 "Technology Rights" means know-how and embodiments of know-how
existing as of the Effective Date relating to Regents' Patents Rights, whether
or not covered by Regents' Patent Rights, for example, data, protocols, cell
lines, and other Materials which pertain to and/or are ancillary to the exercise
of the rights granted herein, and which are listed on Appendix A.
1.5 "Net Sales" means the total of the gross invoice prices of
Licensed Product sold or Licensed Method performed by Licensee, an Affiliate or
a sublicensee, less the sum of the following actual and customary deductions
where applicable: cash, trade or quantity discounts; sales, use, tariff,
import/export duties or other excise taxes imposed on particular sales;
transportation charges; and allowances or credits to customers because of
rejections or returns. For purposes of calculating Net Sales, transfers to an
Affiliate or sublicensee for end use by the Affiliate or sublicensee will be
treated as sales at list price.
1.6 "Regents' Patent Rights" means The Regents' interest in the
following subject matter:
{TABLE}
{CAPTION}
U.S. Application Number
or
UC Case Number U.S. Patent Number Filing or Issue Date
---------------------------------------------------------------------------------------------------
{S} {C} {C}
94-029-2 08/482,551 June 7, 1995
---------------------------------------------------------------------------------------------------
94-029-3 08/858,778 February 7, 1994
---------------------------------------------------------------------------------------------------
94-029-4 09/107,026 June 29, 1998
---------------------------------------------------------------------------------------------------
{/TABLE}
3
{PAGE}
and continuing applications thereof including divisions and substitutions but
excluding continuation-in-part applications; any patents on said applications
including reissues, reexaminations and extensions; and any corresponding foreign
applications or patents.
2. LIFE OF PATENT EXCLUSIVE GRANT
2.1 Subject to the limitations set forth in this Agreement, The
Regents grants to Licensee a world-wide license under Regents' Patent Rights and
Regents' Technology Rights to make, have made, use, sell, offer to sell and
import Licensed Product and to practice Licensed Method.
2.2 Except as otherwise provided in this Agreement, the license
granted in Paragraph 2.1 is exclusive for the life of the Agreement.
2.3 Except as otherwise provided herein, the licenses granted in
Paragraphs 2.1 and 2.2 are for all fields of use.
2.4 The license granted in Paragraphs 2.1 and 2.2 is subject to
all the applicable provisions of any license to the U.S. Government executed by
The Regents and is subject to the overriding obligations to the U.S. Government
under 35 U.S.C. Sections 200-212 and applicable governmental implementing
regulations.
2.5 The Regents reserves the right to use the Invention and
associated technology for clinical, educational and research purposes.
3. SUBLICENSES
3.1 The Regents also grants to Licensee the right to issue
sublicenses to third parties to make, have made, use, sell, offer to sell and
import Licensed Product and to practice Licensed Method, as long as Licensee has
current exclusive rights thereto under this Agreement. To the extent applicable,
sublicenses must include all of the rights of and obligations due to The Regents
and the U.S. Government contained in this Agreement.
3.2 Licensee shall promptly provide The Regents with a copy of
each sublicense issued; collect and guarantee payment of all payments due The
Regents from sublicensees; and summarize and deliver all reports due The Regents
from sublicensees.
3.3 Upon termination of this Agreement for any reason, The
Regents, at its sole discretion, shall determine whether Licensee shall cancel
or assign to The Regents any and all sublicenses.
4
{PAGE}
4. PAYMENT TERMS
4.1 Paragraphs 1.2, 1.3 and 1.6 define Licensed Method, Licensed
Product and Regents' Patent Rights, so that royalties are payable on products
and methods covered by both pending patent applications and issued patents.
Royalties will accrue in each country for the duration of Regents' Patent Rights
in that country and are payable to The Regents when Licensed Product is invoiced
or if not invoiced, when delivered to a third party. In the case of Licensed
Products covered by Regents' Technology Rights but not Regents' Patent Rights,
royalties will accrue for fifteen (15) years from the Effective Date.
4.2 Licensee shall pay to The Regents earned royalties quarterly
on or before February 28, May 31, August 31 and November 30 of each calendar
year. Each payment will be for earned royalties accrued within Licensee's most
recently completed calendar quarter.
4.3 All monies due The Regents are payable in U.S. dollars. When
Licensed Product is sold for monies other than U.S. dollars, Licensee shall
first determine the earned royalty in the currency of the country in which
Licensed Product was sold and then convert the amount into equivalent U.S.
funds, using the exchange rate quoted in The Wall Street Journal on the last
business day of the reporting period.
4.4 Royalties earned on sales occurring in any country outside the
U.S. may not be reduced by any taxes, fees or other charges imposed by the
government of such country on the payment of royalty income. Licensee is also
responsible for all bank transfer charges. Notwithstanding this, all payments
made by Licensee in fulfillment of The Regents' tax liability in any particular
country will be credited against earned royalties or fees due The Regents for
that country.
4.5 If, at any time, legal restrictions prevent the prompt
remittance of royalties by Licensee from any country where a Licensed Product is
sold, Licensee shall convert the amount owed to The Regents into U.S. funds and
shall pay The Regents directly from its U.S. source of funds for as long as the
legal restrictions apply.
4.6 If any patent or patent claim within Regents' 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 that patent or claim or any claim patentably indistinct
therefrom will cease as of the date of final decision. Licensee will not,
however, be relieved from paying any royalties that accrued before the final
decision or that are based on
5
{PAGE}
\
another patent or claim not involved in the final decision or that are based on
The Regents' Technology Rights. If a product is covered by Regents' Technology
Rights but not Regents' Patent Rights, royalties will be reduced by [***].
4.7 No royalties may be collected or paid on Licensed Product sold
to the account of the U.S. Government, any agency thereof, state or domestic
municipal government as provided for in the License to the Government.
4.8 In the event payments, rebillings or fees are not received by
The Regents when due, Licensee shall pay to The Regents interest charges at a
rate of ten percent (10%) per annum. Interest is calculated from the date
payment was due until actually received by The Regents.
5. LICENSE-ISSUE FEE
Licensee shall pay to The Regents a license-issue fee of [***] within
seven (7) days after the Effective Date. This fee is non-refundable,
non-cancelable and is not an advance against royalties.
6. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES
6.1 Licensee shall also pay to The Regents an earned royalty of
[***] of the Net Sales of Licensed Product or Licensed Method.
6.2 Licensee shall pay to The Regents a minimum annual royalty of
[***] for the life of Regents' Patent Rights, beginning with the year of the
first commercial sale of Licensed Product, but no later than [***]. For the
first year of commercial sales, Licensee's obligation to pay the minimum annual
royalty will be pro-rated for the number of months remaining in that calendar
year when commercial sales commence and will be due the following February 28,
to allow for crediting of the pro-rated year's earned royalties. For subsequent
years, the minimum annual royalty will be paid to The Regents by February 28 of
each year and will be credited against the earned royalty due for the calendar
year in which the minimum payment was made.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6
{PAGE}
7. ADDITIONAL PAYMENTS
Clinical Milestone Payment: Licensee shall pay to The Regents [***]
within thirty (30) days of the commencement of the first clinical [***].
Additionally, Licensee shall pay to The Regents [***] within thirty (30) days
after [***].
8. DUE DILIGENCE
8.1 Within one hundred eighty (180) days of the Effective Date,
the Licensee must submit a formal business plan outlining the full operations
including recruitment of key staff and implementation of the research and
development plan for Licensed Products. This plan must include a clear strategy
for financing the Licensee until (1) the Licensee concludes a successful initial
public offering, or (2) the Licensee is acquired by another corporate entity.
8.2 The Licensee, on execution of this Agreement, shall diligently
proceed with the development, manufacture and sale of Licensed Products, either
on its own or with a sublicensee, and shall diligently endeavor to market the
same within a commercially reasonable time after execution of this Agreement.
8.3 The Licensee or its sublicensee shall:
8.3.1 demonstrate the efficacy of a Licensed Product in a
valid animal model [***];
8.3.2 submit an IND covering Licensed Products to the
United States FDA [***];
8.3.3 market Licensed Products [***];
8.3.4 market Licensed Products in the United States [***];
and
8.3.5 reasonably fill the market demand for Licensed
Products following commencement of marketing at any time during the exclusive
period of this Agreement.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7
{PAGE}
If the Licensee is unable to perform any of the provisions in this
Article 8, then The Regents has the right and option either to terminate this
Agreement or convert the Licensee's exclusive license granted to Licensee in
Paragraphs 2.1 and 2.2 to a nonexclusive license.
8.4 In addition to the obligations set forth above, Licensee shall
spend an average of [***] per [***] for the development of [***] on average
during the first [***] after the Effective Date.
9. PROGRESS AND ROYALTY REPORTS
9.1 Beginning February 28, 1999, and semi-annually thereafter,
Licensee shall submit to The Regents a written progress report covering
Licensee's (and any Affiliate or sublicensee's) activities related to the
development and testing of all Licensed Product and the obtaining of the
governmental approvals necessary for marketing. Progress reports are required
for each Licensed Product until the first commercial sale of that Licensed
Product occurs in the U.S. and shall be again required if commercial sales of
such Licensed Product is suspended or discontinued.
9.2 Progress reports submitted under Paragraph 9.1 shall include,
but are not limited to, the following topics:
- summary of work completed
- key scientific discoveries
- summary of work in progress
- current schedule of anticipated events or milestones
- market plans for introduction of Licensed Product and
- a summary of resources (dollar value) spent in the
reporting period.
9.3 Licensee has a continuing responsibility to keep The Regents
informed of the business entity status (as defined by the U.S. Patent and
Trademark Office) of itself and its sublicensees and Affiliates.
9.4 Licensee shall report to The Regents in its immediately
subsequent progress and royalty report the date of first commercial sale of a
Licensed Product in each country.
9.5 After the first commercial sale of a Licensed Product anywhere
in the world, Licensee shall make quarterly royalty reports to The Regents on or
before each February 28, May 31, August 31 and November 30 of each year. Each
royalty report will cover Licensee's most
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8
{PAGE}
recently completed calendar quarter and will show (a) the gross sales and Net
Sales of Licensed Product sold during the most recently completed calendar
quarter; (b) the number of each type of Licensed Product sold; (c) the
royalties, in U.S. dollars, payable with respect to sales of Licensed Product;
(d) the method used to calculate the royalty; and (e) the exchange rates used.
9.6 If no sales of Licensed Product have been made during any
reporting period, a statement to this effect is required.
10. BOOKS AND RECORDS
10.1 Licensee shall keep accurate books and records showing all
Licensed Product manufactured, used and/or sold under the terms of this
Agreement. Books and records must be preserved for at least five (5) years from
the date of the royalty payment to which they pertain.
10.2 Books and records must be open to inspection by
representatives or agents of The Regents at reasonable times. The Regents shall
bear the fees and expenses of examination but if an error in royalties of more
than [***] is discovered in any examination, then Licensee shall bear the fees
and expenses of that examination.
11. LIFE OF THE AGREEMENT
11.1 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 until the last-to-expire patent or patent
application licensed under this Agreement is abandoned and no patent in the
Regents Patent Rights ever issues; or until fifteen (15) years from the
Effective Date as set forth in Paragraph 4.1, whichever is later.
11.2 Any termination of this Agreement will not affect the rights
and obligations set forth in the following Articles:
Article 10 Books and Records
Article 14 Disposition of Licensed Product on Hand Upon Termination
Article 15 Use of Names and Trademarks
Article 20 Indemnification
Article 24 Failure to Perform
Article 29 Secrecy
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
9
{PAGE}
12. TERMINATION BY THE REGENTS
If Licensee fails to perform or violates any term of this Agreement,
then The Regents may give written notice of default ("Notice of Default") to
Licensee. If Licensee fails to repair the default within sixty (60) days of the
effective date of Notice of Default, The Regents may terminate this Agreement
and its licenses by a second written notice ("Notice of Termination"). If a
Notice of Termination is sent to Licensee, this Agreement will automatically
terminate on the effective date of that notice. Such termination will not
relieve Licensee of its obligation to pay any fees owing at the time of
termination and will not impair any accrued right of The Regents. These notices
are subject to Article 21 (Notices).
13. TERMINATION BY LICENSEE
13.1 Licensee has the right at any time to terminate this Agreement
in whole or as to any portion of Regents' Patent Rights by giving notice in
writing to The Regents. Such notice of termination will be subject to Article 21
(Notices) and termination of this Agreement will be effective sixty (60) days
from the effective date of such notice.
13.2 Any termination under the above Paragraph does not relieve
Licensee of any obligation or liability accrued under this Agreement prior to
termination or rescind any payment made to The Regents or anything done by
Licensee prior to the time termination becomes effective. Termination does not
affect in any manner any rights of The Regents arising under this Agreement
prior to termination.
14. DISPOSITION OF LICENSED PRODUCT ON HAND UPON TERMINATION
Upon termination of this Agreement Licensee is entitled to dispose of
all previously made or partially made Licensed Product, but no more, within a
period of one hundred and twenty (120) days provided that the sale of Licensed
Product is subject to the terms of this Agreement, including but not limited to
the rendering of reports and payment of royalties required under this Agreement.
10
{PAGE}
15. USE OF NAMES AND TRADEMARKS
Nothing contained in this Agreement confers any right to use in
advertising, publicity or other promotional activities any name, trade name,
trademark or other designation of either party hereto (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 is prohibited.
16. LIMITED WARRANTY
16.1 The Regents warrants to Licensee that it has the lawful right
to grant this license.
16.2 This license and the associated Invention are provided WITHOUT
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
WARRANTY, EXPRESS OR IMPLIED. THE REGENTS MAKES NO REPRESENTATION OR WARRANTY
THAT THE LICENSED PRODUCT OR LICENSED METHOD WILL NOT INFRINGE ANY PATENT OR
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