[***]=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.
EXHIBIT 10.9
EXCLUSIVE LICENSE AGREEMENT
between
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
and
DYNAVAX TECHNOLOGIES CORPORATION
for
UC Case Nos. 92-296 and 97-138
Method, Compositions and Devices For Administration of Naked Nucleotides Which
Express Biologically Active Peptides,
and
Immunostimulatory Oligonucleotide Conjugates
TABLE OF CONTENTS
Article No./Title Page
----------------- ----
BACKGROUND ............................................................................................... 1
1. DEFINITIONS ........................................................................................... 2
2. LIFE OF PATENT EXCLUSIVE GRANT ........................................................................ 5
3. SUBLICENSES ........................................................................................... 5
4. PAYMENT TERMS ......................................................................................... 6
5. LICENSE-ISSUE FEE ..................................................................................... 8
6. LICENSE MAINTENANCE FEE ............................................................................... 8
7. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES ......................................................... 9
8. ADDITIONAL PAYMENTS ................................................................................... 9
9. DUE DILIGENCE ......................................................................................... 10
10. OPTION ON FUTURE TECHNOLOGY .......................................................................... 12
11. PROGRESS AND ROYALTY REPORTS ......................................................................... 12
12. BOOKS AND RECORDS .................................................................................... 13
13. LIFE OF THE AGREEMENT ................................................................................ 14
14. TERMINATION BY THE REGENTS ........................................................................... 14
15. TERMINATION BY THE LICENSEE .......................................................................... 15
16. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION ............................................ 15
17. USE OF NAMES AND TRADEMARKS .......................................................................... 15
18. LIMITED WARRANTY ..................................................................................... 15
19. PATENT PROSECUTION AND MAINTENANCE ................................................................... 16
20. PATENT MARKING ....................................................................................... 19
21. PATENT INFRINGMENT ................................................................................... 19
22. INDEMNIFICATION ...................................................................................... 20
23. NOTICES .............................................................................................. 21
24. ASSIGNABILITY ........................................................................................ 22
25. NO WAIVER ............................................................................................ 22
26. GOVERNING LAWS ....................................................................................... 22
27. PREFERENCE FOR UNITED STATES INDUSTRY ................................................................ 23
28. GOVERNMENT APPROVAL OR REGISTRATION .................................................................. 23
29. EXPORT CONTROL LAWS .................................................................................. 23
30. SECRECY .............................................................................................. 23
31. MISCELLANEOUS ........................................................................................ 25
CASE NOS. 92-296 & 97-138
EXCLUSIVE LICENSE AGREEMENT
for
Method, Compositions and Devices For Administration of Naked Nucleotides Which
Express Biologically Active Peptides
and
Immunostimulatory Oligonucleotide Conjugates
This license agreement (the "Agreement") is made effective this 26th
day of March, 1997 (the "Effective Date") between THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA, a California corporation having its statewide administrative
offices at 000 Xxxxxxxx Xxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000, ("The
Regents"), and Dynavax Technologies Corporation, a California corporation having
a principal place of business at Alta Partners, Xxx Xxxxxxxxxxx Xxxxxx, Xxx
Xxxxxxxxx, XX 00000, (the "Licensee").
BACKGROUND
A. Certain inventions, generally characterized in the patent
applications entitled "Method, Compositions and Devices For Administration of
Naked Nucleotides Which Express Biologically Active Peptides" UC Case No. 92-296
and "Immunostimulatory Nucleotide Sequences" UC Case No. 97-138 (collectively
the "Invention"), were made in the course of research at the University of
California, San Diego by Drs. Xxxxxx X. Xxxxxx, Xxxx Xxx and Xxxxxxxx Xxxxxx and
are covered by Regents' Patent Rights as defined below;
1
B. The development of the Invention was sponsored in part by the
National Institutes of Health and as a consequence this license is subject to
overriding obligations to the Federal Government under 35 U.S.C. Sections
200-212 and applicable regulations;
C. The development of the Invention was sponsored also in part by
Ciba-Geigy Ltd., which has waived its rights to the Invention in a letter to The
Regents dated May 14, 1996;
D. The Licensee has evaluated the Invention under a Secrecy
Agreement with The Regents dated July 15, 1996 (U.C. Control No. 97-20-0023);
E. The Licensee wished to obtain rights from The Regents for the
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. The Licensee is a "`small business concern" as defined
pursuant to 15 U.S.C. Section 632; and
G. Both parties recognize and agree that royalties due under this
Agreement will be paid on both pending patent applications and issued patents.
- - oo 0 oo - -
In view of the foregoing, the parties agree:
1. DEFINITIONS
1.1 "Regent's Patent Rights" means any subject matter claimed or
disclosed in any of the following:
CASE NUMBER U.S. PATENT APPLICATION FILING DATE
SERIAL NUMBER
--------------------------------------------------------------------------------
92-296-1 08/112,440 August 26, 1993 - (now
abandoned)
92-296-2 08/464,878 June 7, 1995
2
92-296-3 08/333,068 November 1, 1994
92-296-4 08/334,260 November 3, 1994
92-296-5 [***] [***]
92-296-6 [***] [***]
92-296-7 [***] [***]
92-296-8 [***] [***]
92-296-9 [***] [***]
92-296-A 08/593,554 January 30, 1996
92-296-B 08/725,968 October 4, 1996
97-138-1 60/028,118 October 11, 1996
by Drs. Xxxxxx X. Xxxxxx, Xxxx Xxx and Xxxxxxxx Xxxxxx and assigned to
The Regents; and continuation applications thereof, and divisions,
substitutions, and continuation-in-part applications, but only to the extent
claims in any such continuation-in-part application contain subject matter
included in the foregoing listed applications as originally filed in the U.S.
Patent and Trademark Office ("USPTO"); any patents issuing on said applications
including reissues, reexaminations and extensions; and any corresponding foreign
applications or patents (including inventor's certificates).
1.2 "Licensed Product" means any machine, manufacture or
composition of matter that is either claimed or disclosed in Regents' Patent
Rights, or that is produced by the Licensed Method or, the use of which would
constitute, but for the license granted to the Licensee under this Agreement, an
infringement of any pending or issued claim within Regents' Patent Rights.
1.3 "Licensed Method" means any method that is claimed or
disclosed in Regents' Patent Rights, the use of which would constitute, but for
the license granted to the Licensee under this Agreement, an infringement of any
pending or issued claim within Regents' Patent Rights.
[***]=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.
3
1.4 "Net Sales" means the total of the gross invoice prices of
Licensed Products sold or Licensed Methods performed by the Licensee, or an
Affiliate or a sublicensee of Licensee, 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; credits to customers
because of rejections or returns or discounts actually allowed. For purposes of
calculating Net Sales, transfers to an Affiliate or sublicensee for end use for
purposes other than performing research and development of Licensed Products by
the Affiliate or sublicensee will be treated as sales at list price.
1.5 "Affiliate" means any corporation or other business entity
which the 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 by which the 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 the 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.
1.6 "Attributed Income" means the following types of income
received by Licensee which is attributable to the Invention licensed hereunder:
upfront licensing fees paid to Licensee by third parties (e.g. corporate
partners and sublicensees of Licensee) and licensing and/or research and
development (R&D) milestone payments made to Licensee for the development of
Licensed Products which milestone payments are payable prior to (but not after)
the commencement of clinical trials for a Licensed Product to which the income
is attributable. Attributed Income does not include amounts received by Licensee
from third parties for the purchase of an equity interest in Licensee (except
amounts in excess of the fair market value of Licensee's stock at the time such
purchase is made), amounts received to fund Licensee's research and development
efforts (charged at cost), amounts received by Licensee
4
as a loan subject to repayment, or reimbursement of patent costs, or amounts
received by Licensee for research and development and/or licensing of technology
not covered by Regents' Patent Rights.
2. LIFE OF PATENT EXCLUSIVE GRANT
2.1 Subject to the limitations set forth in this Agreement, The
Regents grants to the Licensee a world-wide license under Regents' Patent Rights
to make, have made, use and sell 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 this Agreement.
2.3 The license granted in Paragraphs 2.1 and 2.2 is subject to
all the applicable provisions of any license to the United States Government
executed by The Regents and is subject to the overriding obligations to the U.S.
Government under 35 U.S.C. section 200-212 and applicable governmental
implementing regulations.
2.4 The Regents reserves the right to use the Invention and
associated technology for its own noncommercial educational and research
purposes.
3. SUBLICENSES
3.1 The Regents also grants to the Licensee the right to issue
sublicenses to third parties to make, have made, use and sell Licensed Product
and to practice Licensed Method, as long as the 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, if
applicable, the United States Government) contained in this Agreement.
3.2 The 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. All information provided pursuant to this Paragraph 3.2 shall
be deemed Confidential Information of Licensee for the purposes of Article 30
(Secrecy).
5
3.3 Upon termination of this Agreement for any reason, The Regents
shall allow sublicensees to become direct licensees of the rights granted
herein, to the extent that it is not unreasonable for The Regents to do so as a
public entity and provided that:
3.3.1 The Licensee was not in breach of this Agreement when
entering into the sublicense;
3.3.2 The sublicensee is not in breach of its sublicense
agreement at the time of termination of this
Agreement; and
3.3.3 The sublicensee acquires no rights from or
obligations on the part of The Regents other than
those that are specifically granted in this
Agreement, and the sublicensee assumes all
obligations to The Regents required of Licensee by
this Agreement, including past due obligations
existing at the time of assumption of this
sublicense, as well as any additional payments
required by the sublicense.
4. PAYMENT TERMS
4.1 Paragraphs 1.1, 1.2, and 1.3 define Regents' Patent Rights,
Licensed Products and Licensed Methods so that royalties are payable on products
and methods covered by both pending patent applications and issued patents.
However, if no patent has issued on a particular U.S. or national-phase filed
foreign patent application within [***] after such application was so filed,
then all obligation to pay royalties on sales of Licensed Products which are
solely claimed by that patent application will be suspended until the patent has
issued. When such patent does issue, Licensee shall resume paying royalties
based on the issued patent as of the date of issuance. Licensee shall also pay
to The Regents, within sixty (60) days of issuance all back royalties which
accrued during the period of suspended royalties. Royalties will accrue in each
country for the duration of Regents' Patent Rights in that country and are
payable to The Regents when Licensed Products are invoiced, or if not invoiced,
when delivered to a third party.
[***]=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
4.2 Licensee shall pay earned royalties quarterly within sixty
(60) days after each calendar quarter. Each payment will be for earned royalties
accrued within the Licensee's most recently completed calendar quarter.
4.3 All monies due The Regents are payable in United States
dollars. When Licensed Products are sold for monies other than United States
dollars, the Licensee shall first determine the earned royalty in the currency
of the country in which Licensed Products were sold and then convert the amount
into equivalent United States 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
United States may not be reduced by any taxes, fees, or other charges imposed by
the government of such country on the payment of royalty income. The Licensee is
also responsible for all bank transfer charges. Notwithstanding this, all
payments made by the 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 legal restrictions prevent the prompt remittance of
royalties by the Licensee from any country where a Licensed Product is sold, the
Licensee shall deposit the amount owed to The Regents into an interest bearing
account in the applicable country in the name of The Regents until the
restrictions are removed. However, if these restrictions persist for longer than
a year, the Licensee shall calculate the amount owed United States funds and
shall pay The Regents that amount and all subsequent royalties owed to The
Regents directly from its U.S. source of funds.
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. The Licensee will not,
however, be relieved from paying any royalties that accrued before the final
decision or that are based on another patent or claim not involved in the final
decision.
7
4.7 No royalties may be collected or paid on Licensed Products
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.
In the event payments, rebillings or fees are not received by The
Regents when due, the Licensee shall pay to The Regents interest charges at a
rate of [***]. Interest is calculated from the date payment was due until the
day payment is actually received by The Regents.
5. LICENSE-ISSUE FEE
The Licensee shall pay to The Regents a license issue fee of [***] in
two installments as follows: the first payment of [***] shall be paid within
seven (7) days of the Effective Date and the second payment of [***] shall be
paid on the first anniversary of the Effective Date. The license issue fee is
non-refundable, non-cancelable and is not an advance against royalties.
6. LICENSE MAINTENANCE FEE
The Licensee shall also pay to The Regents a license maintenance fee of
[***] beginning on the second anniversary of the Effective Date and continuing
annually on each anniversary of the Effective Date, provided, however, that the
maintenance fee is not due on any anniversary of this Agreement if on that date
the Licensee is commercially selling a Licensed Product and paying an earned
royalty or a minimum annual royalty to The Regents on the sales of that Licensed
Product exceeding such maintenance fee amount of [***] for the preceding year.
License maintenance fees are non-refundable and are not an advance against
earned royalties.
[***]=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
7. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES
7.1 The Licensee shall also pay to The Regents an earned royalty
of [***] of the Net Sales of any Licensed Product by the Licensee or any
sublicensee. Licensee shall pay such earned royalty at the time it submits the
relevant quarterly royalty report pursuant to Paragraph 11.5.
7.2 The Licensee shall pay to The Regents a minimum annual royalty
of [***] per year for human therapeutic Licensed Products, and [***] per year
for all other Licensed Products for the term of Regents' Patent Rights,
beginning with the year of the first year of commercial sales for each Licensed
Product. For the first year of commercial sales, the 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 the minimum
annual royalty 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.
8. ADDITIONAL PAYMENTS
8.1 Clinical Milestone Payment: Licensee shall pay to The Regents
[***] within thirty (30) days of the commencement of a clinical [***]. Such
payment shall be made for [***]. Additionally, Licensee shall pay to The Regents
[***] within thirty (30) days after [***], and [***] within thirty (30) days
after [***].
[***]=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
8.2 Patent Milestone Payment: Within thirty (30) days of
notification by the USPTO of the allowance of any claim included within Regents'
Patent Rights claiming any one of the following technologies: [***], the
Licensee shall pay The Regents a one-time cash payment of [***].
8.3 Indexed Milestone Payment: Within sixty (60) days of either
(a) the closing of a public offering of the common stock pursuant to a
registration statement filed with the Securities and Exchange Commission or (b)
any consolidation or merger of Licensee with any other entity, or any other
corporate reorganization following which the shareholders of Licensee
immediately prior thereto own less than sixty percent (60%) of Licensee's voting
power, or any transaction or series of transactions in which greater than forty
percent (40%) of Licensee's voting power is transferred to a third party not
previously a share holder of Licensee; Licensee shall make to The Regents a cash
payment equal to [***].
8.4 Income: Within sixty (60) days of Licensee's receipt of
Attributed Income, Licensee shall pay to The Regents [***]. These payments by
Licensee shall continue until the earlier to occur of (i) an aggregate of [***]
has been paid under this Paragraph 8.4, or (ii) [***].
9. DUE DILIGENCE
9.1 The Licensee shall sponsor research in the laboratory of Dr.
Xxxxxxx Xxxx at the University of California San Diego, and such sponsored
research will be for a two (2) year period of not less than [***], pursuant to
the research agreement between The Regents of the University
[***]=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.
10
of California and Licensee dated November 22, 1996, which is attached as Exhibit
"A" ("Research Agreement").
9.2 The Licensee must make commercially reasonable efforts to
execute at least one agreement with a corporate partner within [***].
9.3 Furthermore, 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. 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.
9.4 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.
9.5 The Licensee or its sublicensee shall:
9.5.1 submit an IND covering Licensed Products to the
United States FDA [***];
9.5.2 demonstrate the efficacy of a Licensed Product in a
scientifically valid animal model [***];
9.5.3 market Licensed Products [***];
9.5.4 market Licensed Products in the United States [***];
and 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.
11
If the Licensee is unable to perform any of the provisions in this
Article 9, then The Regents has the right and option either to terminate this
Agreement or convert the exclusive license granted to Licensee in Paragraphs 2.1
and 2.2 to a nonexclusive license.
10. OPTION ON FUTURE TECHNOLOGY
Subject to the terms of the Research Agreement, attached hereto as
Exhibit "A," the Licensee shall have an option to obtain an exclusive license to
The Regents' rights in inventions conceived and reduced to practice during the
term of the Research Agreement and as a result of research fully funded by the
Licensee in the laboratory of Dr. Xxxxxxx Xxxx at the University of California,
San Diego. The terms of such license shall be agreed upon by the parties
pursuant to good faith negotiations conducted within a reasonable time after any
invention is disclosed to Licensee, as provided for in the terms of the Research
Agreement.
11. PROGRESS AND ROYALTY REPORTS
11.1 Beginning August 28, 1997 and semi-annually thereafter, the
Licensee shall submit to The Regents a written progress report covering the
Licensee's (and any Affiliate or sublicensee's) activities related to the
development and testing of all Licensed Products 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 United States and shall be again required if commercial
sales of such Licensed Product are suspended or discontinued.
11.2 Progress reports submitted under Paragraph 11.1 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
12
- market plans for introduction of Licensed Products,
and
- a summary of resources (dollar value) spent in the
reporting period.
11.3 The Licensee has a continuing responsibility to keep The
Regents informed of the large/small business entity status (as defined by the
USPTO) of itself and its sublicensees and Affiliates.
11.4 The Licensee shall promptly report to The Regents in its
progress report the date of first commercial sale of a Licensed Product in each
country.
11.5 After the first commercial sale of a Licensed Product anywhere
in the world, the Licensee shall make quarterly royalty reports to The Regents
within sixty (60) days after each calendar quarter of each year. Each royalty
report will cover the Licensee's most recently completed calendar quarter and
will show (a) the gross sales and Net Sales of Licensed Products 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 Products; (d) the method used to calculate the royalty; and
(e) the exchange rates used.
11.6 If no sales of Licensed Products have been made during any
reporting period, the royalty report shall include a statement to this effect.
12. BOOKS AND RECORDS
12.1 The Licensee shall keep accurate books and records showing all
Licensed Products 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.
12.2 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 the Licensee shall bear the
fees and expenses of that examination.
[***]=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.
13
13. LIFE OF THE AGREEMENT
13.1 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 either the expiration date of the
last-to-expire patent licensed under this Agreement, or if no patent included in
Regents' Patent Rights has issued, until the date upon which the last patent
application licensed under this Agreement is abandoned.
13.2 Any termination of this Agreement will not affect the rights
and obligations set forth in the following Articles:
Paragraph 8.3 Indexed Milestone Payment
Article 12 Books and Records
Article 16 Disposition of Licensed Products on Hand on Termination
Article 17 Use of Names and Trademarks
Article 22 Indemnification
Article 30 Secrecy
14. TERMINATION BY THE REGENTS
If the Licensee fails to perform or violates any term of this
Agreement, including failure to sponsor research for at least two (2) years
pursuant to the Research Agreement attached hereto as Exhibit "A" (as provided
for in Article 10), then The Regents may give written notice of default (Notice
of Default) to the Licensee. If the 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 the Licensee, this Agreement
will automatically terminate on the effective date of that notice. Termination
will not relieve the 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 23 (Notices).
14
15. TERMINATION BY LICENSEE
15.1 The 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. Notice of termination will be subject to
Article 23 (Notices) and termination of this Agreement will be effective sixty
(60) days from the date such notice is received by The Regents.
15.2 Any termination under the above Paragraph does not relieve the
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.
16. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION
Upon termination of this Agreement the Licensee is entitled to dispose
of all previously made or partially made Licensed Products, but no more, within
a period of one hundred and twenty (120) days provided that the sale of those
Licensed Products 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.
17. 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 the Licensee of the name "The Regents of the University of California" or
the name of any campus of the University of California is prohibited.
18. LIMITED WARRANTY
18.1 The Regents warrants to the Licensee that it has the lawful
right to grant the rights The Regents purports to grant to Licensee under this
license.
15
18.2 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 MANUFACTURE, USE, SALE, OFFER FOR SALE OR IMPORT OF THE LICENSED
PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY
RIGHT.
18.3 IN NO EVENT MAY THE REGENTS BE LIABLE FOR ANY INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR THE
USE OF THE INVENTION OR LICENSED PRODUCTS.
18.4 This Agreement does not:
18.4.1 express or imply a warranty or representation as to
the validity or scope of any of Regents' Patent
Rights;
18.4.2 express or imply a warranty or representation that
anything made, used, sold, offered for sale or
imported or otherwise disposed of under any license
granted in this Agreement is or will be free from
infringement of patents of third parties;
18.4.3 obligate The Regents to bring or prosecute actions or
suits against third parties for patent infringement
except as provided in Article 21;
18.4.4 confer by implication, estoppel or otherwise any
license or rights under any patents of The Regents
other than Regents' Patent Rights as defined in this
Agreement, regardless of whether those patents are
dominant or subordinate to Regents' Patent Rights; or
18.4.5 obligate The Regents to furnish any know-how not
provided in Regents' Patent Rights.
19. PATENT PROSECUTION AND MAINTENANCE
19.1 As long as the Licensee has paid patent costs as provided for
in this Article, The Regents shall diligently endeavor to prosecute and maintain
the United States and foreign
16
patents comprising Regents' Patent Rights using counsel of its choice. The
Regents shall provide the Licensee with copies of all documentation relevant to
any filings relating to The Regents' Patent Rights to be made with the USPTO
reasonably in advance of the anticipated submission date thereof, so that the
Licensee may be informed of and comment upon such filings. The Licensee agrees
to keep this documentation confidential. The Regents will incorporate Licensee's
comments into the proposed filing where reasonably practicable, provided
however, that The Regents' counsel will take instructions only from The Regents,
and all patents and patent applications under this Agreement will be assigned
solely to The Regents.
19.2 The Regents shall use all reasonable efforts to amend any
patent application to include claims reasonably requested by the Licensee to
protect the products contemplated to be sold under this Agreement.
19.3 The Licensee shall apply for an extension of the term of any
patent included within Regents' Patent Rights which may be available under the
Drug Price Competition and Patent Term Restoration Act of 1984 and/or European,
Japanese and other foreign counterparts of this Law. The Licensee shall prepare
all documents, and The Regents agrees to execute the documents and to take
additional action as the Licensee reasonably requests in connection therewith.
19.4 If either party receives notice pertaining to infringement or
potential infringement of any issued patent included within Regents' Patent
Rights under the Drug Price Competition and Patent Term Restoration Act of 1984
(and/or foreign counterparts of this Law), that party shall notify the other
party within ten (10) days after receipt of notice of infringement.
19.5 The Regents shall file, prosecute and maintain all US and
foreign patent applications and patents included within Regents' Patent rights.
19.6 The Licensee shall bear the costs of preparing, filing,
prosecuting and maintaining all United States and foreign patents and patent
applications contemplated by this Agreement. Costs billed by The Regents' patent
counsel relating to such patents and patent applications will be rebilled to the
Licensee and are due within thirty (30) days of rebilling by
17
The Regents. These costs include patent prosecution costs for the Invention
incurred by The Regents prior to the execution of this Agreement and any patent
prosecution costs that may be incurred for patentability opinions,
re-examination, re-issue, interferences, or inventorship determinations.
19.7 The Licensee may request The Regents to obtain patent
protection on the Invention in foreign countries if available and if it so
desires. The Licensee shall notify The Regents of its decision to obtain or
maintain foreign patents not less than sixty (60) days prior to the deadline for
any payment, filing, or action to be taken in connection therewith, provided
that The Regents will use reasonable efforts to inform Licensee of impending
deadlines as soon as it becomes aware thereof this notice concerning foreign
filing must be in writing, must identify the countries desired, and must
reaffirm the Licensee's obligation to underwrite the costs thereof. The absence
of such a notice from the Licensee to The Regents will be considered an election
not to obtain or maintain foreign rights, provided that The Regents have
notified Licensee of the relevant deadline as provided herein.
19.8 The Licensee's obligation to underwrite and to pay patent
prosecution costs will continue for so long as this Agreement remains in effect,
but the Licensee may terminate its obligations with respect to any given patent
application or patent upon three (3) months' prior written notice to The
Regents. The Regents will use its best efforts to curtail patent costs when a
notice of termination is received from the Licensee. The Regents may prosecute
and maintain such application(s) or patent(s) at its sole discretion and
expense, but the Licensee will have no further right or licenses thereunder.
Non-payment of patent costs may be deemed by The Regents as an election by the
Licensee not to maintain application(s) or patent(s).
19.9 The Regents may file, prosecute or maintain patent
applications at its own expense in any country in which the Licensee has not
elected to file, prosecute, or maintain patent applications in accordance with
this Article, and those applications and resultant patents will not be subject
to this Agreement.
18
20. PATENT MARKING
The Licensee shall xxxx all Licensed Products made, used or sold under
the terms of this Agreement, or their containers, in accordance with the
applicable patent marking laws.
21. PATENT INFRINGEMENT
21.1 If the Licensee learns of the material infringement of any
patent licensed under this Agreement, the Licensee shall call The Regents'
attention thereto in writing and provide The Regents with reasonable evidence of
infringement. Neither party will notify a third party of the infringement of any
of Regents' Patent Rights without first obtaining consent of the other party,
which consent will not be unreasonably denied. Both parties shall use reasonable
efforts in cooperation with each other to terminate infringement without
litigation.
21.2 The Licensee may request that The Regents take legal action
against the infringement of Regents' Patent Rights. Request must be in writing
and must include reasonable evidence of infringement and damage to the Licensee.
If the infringing activity has not abated within ninety (90) days following the
effective date of request, The Regents then has the right to:
21.2.1 commence suit on its own account; or 21.2.2 refuse to
participate in the suit,
and The Regents shall give notice of its election in writing to the
Licensee by the end of the one-hundredth (100th) day after receiving notice of
written request from the Licensee. The Licensee may thereafter bring suit for
patent infringement, at its own expense, if, and only if, The Regents elects not
to commence suit and if the infringement occurred during the period and in a
jurisdiction where the Licensee had exclusive rights under this Agreement. The
Licensee elects to bring suit in accordance with this paragraph, The Regents may
thereafter join that suit at its own expense.
21.3 Any suit brought pursuant to this Paragraph 21.3 will be at
the expense of the party bringing suit and all damages recovered thereby will
belong to the party bringing suit. Any legal action brought jointly by The
Regents and the Licensee will be at the joint expense
19
of the parties and all recoveries will be shared jointly by them in proportion
to the share of expenses paid by each party.
21.4 Each party shall cooperate with the other party in litigation
proceedings instituted hereunder at the expense of the party bringing suit.
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 the Licensee.
22. INDEMNIFICATION
22.1 The Licensee shall indemnify, hold harmless and defend The
Regents, its officers, employees, and agents; the sponsors of the research that
led to the Invention; and the inventors of the patents and patent applications
in Regents' Patent Rights and their employers against any and all claims, suits,
losses, liabilities, damages, costs, fees, and expenses resulting from or
arising out of exercise of this license or any sublicense, except to the extent
any claims result from or arise out of the gross negligence, recklessness or
willful misconduct of The Regents, its officers, employees, and agents; the
sponsors of the research that led to the Invention; and the inventors of the
patents and patent applications in Regents' Patent Rights and their employers.
This indemnification includes, but is not limited to, any product liability
claims.
22.2 The Licensee, at its sole cost and expense, shall 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:
22.3 Comprehensive or commercial form general liability insurance
(contractual liability included) with limits as follows:
- Each Occurrence $1,000,000
- Products/Completed Operations Aggregate $5,000,000 (upon the
initiation of Phase I clinical trials)
- Personal and Advertising Injury $1,000,000
20
- General Aggregate (commercial form only) $3,000,000 until the
commencement of Phase I clinical trials, at which point such
coverage shall be for $5,000,000
The coverage and limits referred to under the above do not in any way
limit the liability of the Licensee. The Licensee shall furnish The Regents with
certificates of insurance showing compliance with all requirements under this
Paragraph 22.3. Certificates must:
- Provide for thirty (30) days' advance written notice to The
Regents of any modification.
- Indicate that The Regents has been endorsed as an additional
insured under the policy.
- Include a provision specifying that the coverage 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.
22.4 The Regents shall notify the Licensee in writing of any claim
or suit brought against The Regents with respect to which The Regents intends to
invoke the provisions of this Article. The Licensee shall keep The Regents
informed on a current basis of its defense of any claims under this Article.
23. NOTICES
Any notice or payment required to be given to either party is properly
given and effective (a) on the date of delivery if delivered in person or (b)
five (5) days after mailing if mailed by first-class certified mail, postage
paid, to the respective addresses given below, or (c) on the date of
transmission by facsimile, as evidenced by a written confirmation thereof, or to
another address or facsimile number as is designated by written notice given to
the other party.
21
In the case of the Licensee: DYNAVAX TECHNOLOGIES CORPORATION
000 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000-0000
Attention: Xxx Xxxxxxx
Fax: (000) 000-0000
In the case of The Regents: THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA
Office of Technology Transfer
0000 Xxxxxx Xxx Xxxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Executive Director
Research Administration and
Technology Transfer
Referring to: UC Case Nos. 92-296 & 97-138
FAX: (000) 000-0000
24. ASSIGNABILITY
This Agreement may be assigned by The Regents, but is personal to the
Licensee and assignable by the Licensee only with the written consent of The
Regents, which consent will not be unreasonably withheld.
25. NO WAIVER
No waiver by either party of any default of this Agreement may be
deemed a waiver of any subsequent or similar default.
26. GOVERNING LAWS
THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE
LAWS OF THE STATE OF CALIFORNIA, but the scope and validity of any patent or
patent application will be governed by the applicable laws of the country which
granted such patent or in which country such patent application was filed.
22
27. PREFERENCE FOR UNITED STATES INDUSTRY
Because this Agreement grants the exclusive right to use or sell the
Invention in the United States, the Licensee agrees that any products sold in
the U.S. embodying this Invention or produced through the use thereof will be
manufactured substantially in the United States.
28. GOVERNMENT APPROVAL OR REGISTRATION
Licensee shall notify The Regents if it becomes aware that this
Agreement is subject to any U.S. or foreign government reporting or approval
requirement. Licensee shall 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.
29. EXPORT CONTROL LAWS
The Licensee shall observe all applicable United States and foreign
laws with respect to the transfer of Licensed Products and related technical
data to foreign countries, including, without limitation, the International
Traffic in Arms Regulations (ITAR) and the Export Administration Regulations.
30. SECRECY
30.1 With regard to confidential information ("Confidential
Information"), whether in oral, written or electronic form, received from a
party regarding this Invention or this Agreement, the receiving party agrees:
30.1.1 not to use the Confidential Information except for
the sole purpose of performing under the terms of
this Agreement;
30.1.2 to safeguard Confidential Information against
disclosure to others with the same degree of care as
it exercises with its own data of a similar nature;
30.1.3 not to disclose Confidential Information to others
(except to its employees, agents or consultants who
are bound to the receiving party
23
by a like obligation of confidentiality) without the
express written permission of the disclosing party,
except that the receiving party is not prevented from
using or disclosing any of the Confidential
Information that:
30.1.3.1 the receiving party can demonstrate by
written records was previously known to it
or independently developed by it;
30.1.3.2 is now, or becomes in the future, public
knowledge other than through acts or
omissions of the receiving party; or
30.1.3.3 is lawfully obtained by the receiving party
from sources independent of the disclosing
party; and
30.1.4 that the secrecy obligations of the receiving party
with respect to Confidential Information will
continue for a period ending five (5) years from the
termination date of this Agreement.
30.2 With regard to biological material received by Licensee from
The Regents, if any, including any cell lines, vectors, genetic material,
derivatives, products progeny or material derived therefrom ("Biological
Material"), the Licensee agrees:
30.2.1 not to use Biological Material except for the sole
purpose of performing under the terms of this
Agreement;
30.2.2 not to transfer Biological Material to others (except
to its employees, agents or consultants who are bound
to the Licensee by like obligations restricting
access to and use of Biological Material) without the
express written permission of The Regents, except
that the Licensee is not prevented from transferring
Biological Material that:
30.2.2.1 becomes publicly available other than
through acts or omissions of the Licensee;
or
30.2.2.2 is lawfully obtained by the Licensee from
sources independent of The Regents;
24
30.2.3 to safeguard Biological Material against disclosure
and transmission to others with the same degree of
care as it exercises with its own biological
materials of a similar nature;
30.2.4 to destroy all copies of Biological Material at the
termination of this Agreement.
31. MISCELLANEOUS
31.1 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.
31.2 This Agreement is not binding on the parties until it has been
signed below on behalf of each party. It is then effective as of the Effective
Date.
31.3 No amendment or modification of this Agreement is valid or
binding on the parties unless made in writing and signed on behalf of each
party.
31.4 This Agreement including Exhibit A embodies the entire
understanding of the parties and supersedes all previous communications,
representations or understandings, either oral or written, between the parties
relating to the subject matter hereof, including the Secrecy Agreement dated
July 15, 1996.
This Agreement does not supersede, alter or amend the Research
Agreement attached hereto as Exhibit A. However, in the event
of any conflict between the terms of this Agreement and the
Research Agreement, the terms of this Agreement will control
for purpose of interpreting this Agreement.
31.5 In case any of the provisions contained in this Agreement is
held to be invalid, illegal, or unenforceable in any respect, that invalidity,
illegality or unenforceability will not affect any other provisions of this
Agreement, and this Agreement will be construed as if the invalid, illegal, or
unenforceable provisions had never been contained in it.
25
IN WITNESS WHEREOF, both The Regents and the Licensee have executed
this Agreement, in duplicate originals, by their respective and duly authorized
officers on the day and year written.
DYNAVAX TECHNOLOGIES THE REGENTS OF THE UNIVERSITY OF
CORPORATION CALIFORNIA
By: /s/ Xxxxxx X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxxxx
---------------------------- --------------------------
(Signature) (Signature)
Name: Xxxxxx X. Xxxxxx Name: Xxxxxxx X. Xxxxxxxxx
(Please Print)
Title: President Title: Executive Director
Research Administration and
Technology Transfer
Date: 3/14/97 Date: 3/26/97
Approved as to legal form: /s/ Xxxxx X. Xxxxx 3/19/97
----------------------------
Xxxxx X. Xxxxx Date
University Counsel
Office of General Counsel
26
EXHIBIT "A"
RESEARCH AGREEMENT
This Agreement is made by and between Dynavax Technologies Corporation
("Sponsor") with offices at Alta Partners, Xxx Xxxxxxxxxxx Xxxxxx, Xxxxx 0000,
Xxx Xxxxxxxxx, Xxxxxxxxxx, 00000, and The Regents of the University of
California, a California Corporation having its principal office at 000 Xxxxxxxx
Xxxxx, Xxxxxxx, XX 00000-0000, on behalf of the University of California, San
Diego campus ("University").
WHEREAS, it is in the mutual interest of Sponsor and University that
research be conducted on a Biotechnology Star Project by Xx. Xxxx Xxx and Xx.
Xxxxxx Xxxxxx entitled "Inhibition of Allergic Responses by Gene Immunotherapy"
(Project);
WHEREAS, Sponsor desires to financially support said research at
University;
NOW, THEREFORE, the parties agree as follows:
1. SCHEDULE - The Project shall be conducted in accordance with the
statement of work attached hereto as Exhibit "A" and incorporated into this
Agreement by this reference solely for the purpose of describing the scope of
work to be performed under this Agreement. The term of this Agreement shall be 1
January 1997 through 31 December 1998, unless sooner terminated as herein
provided.
1
2. BUDGET - Sponsor shall support the Project by a grant of [***] and the
University shall support the project with a match of [***]. The grant amount
shall cover all direct and indirect costs of the Project, as set forth in the
budget attached hereto as part of the grant proposal set forth in Exhibit "A"
and incorporated into this Agreement and the Sponsor grant amount shall be paid
as set forth in Section 3. If at any time University has reason to believe that
the cost of the Project will be greater than the amount budgeted, University
shall notify Sponsor in writing to that effect, giving a revised budget of the
cost of completion of the Project. Sponsor shall not be obligated to reimburse
University for the costs incurred in excess of the Budget unless and until
Sponsor has notified University in writing that the revised budget is accepted.
Upon expenditure of the accepted budget amount, University's obligation to
continue performance of the Project shall cease. If the Project period is more
than one year, the balance of any funds remaining at the end of any Project year
may be carried over to subsequent years during the period of the Agreement to
support the Project.
3. PAYMENT - Upon execution of this agreement, Sponsor will provide
payment in the amount of [***].
Payment shall be made to "The Regents of the University of California"
and sent to the following:
[***]=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
The Regents of the University of California
c/o Xxxx Xxxxx
Manager, Extramural Funds Accounting
University of California, San Diego
0000 Xxxxxx Xxxxx
Xx Xxxxx, XX 00000-0000
At least thirty (30) days prior to the beginning of each quarter
thereafter, Sponsor will make a payment to the University in an amount equal to
one-quarter of the annual budget amount. Upon request by Sponsor, the University
will provide to Sponsor a report of expenditures shown by major cost categories
for the prior annual accounting period.
4. PRINCIPAL INVESTIGATOR - The research is to be conducted by University
under the direction of Xx. Xxxx Xxx ("Principal Investigator") who will be
responsible for the direction of the Project, including all budgeting and
revisions to the Budget, in accordance with applicable University policies. The
Principal Investigator is considered essential to the work being performed and
no substitution may be made without the prior written concurrence of the
Sponsor.
Principal Investigator shall keep Sponsor regularly informed of
progress under this Agreement and shall deliver summary quarterly reports and a
detailed final report upon conclusion of this project.
5. CONFIDENTIALITY - Subject to Paragraph 9 of this Agreement, it
3
is the intent of the parties that neither party shall furnish any information
considered confidential and/or proprietary by it and/or one or more third
parties to the other party in connection with this Agreement.
Should Sponsor deem it necessary to disclose information considered
confidential and/or proprietary by it to University, it will be clearly marked
by Sponsor, in writing, as "Confidential Information". Except as required by
law, University will not disclose confidential information for a period of five
years from the end of this Agreement, and shall use such Confidential
Information solely to perform its obligations under this Agreement. This
obligation does not apply to information that was known to University prior to
its receipt from Sponsor (as evidenced by the University's written records),
that is independently developed by the University, or becomes known at any time
to third parties without any breach of confidential obligations by the
University.
University will use its best efforts to protect the confidentiality of
such information while in its possession, and may disclose such information only
to University employees, agents or consultants who require access to such
information for the purpose of performing under this Agreement, and who are
bound to keep such information confidential.
6. RIGHTS IN DATA - Subject to Paragraph 5 and 8 of this
4
Agreement, University shall have the right to copyright, publish, disclose,
disseminate and use, in whole and in part, any data and information received or
developed under the Project. Subject to Paragraphs 8 and 9 of this Agreement,
Sponsor shall have the right to disclose, publish and use the technical reports,
data and information delivered under the Project to Sponsor by University.
7. USE OF NAME/PUBLICITY - It is agreed by each party that it will not
under any circumstance use the name of the other party or its employees in any
advertisement, press release or publicity with reference to this Agreement,
without prior written approval of the other party, except as required by law.
8. PUBLICATION - University shall have the right to publish the results of
the work conducted by University under this Agreement to the extent such results
do not contain Confidential Information of Sponsor, provided Sponsor has the
opportunity to review and comment on any proposed manuscripts describing said
work thirty (30) days prior to their submission to a third party for publication
and the University agrees to consider Sponsor's comments prior to publication.
However, if submission of such manuscript for publication would cause the loss
of significant foreign patent rights, University will, at its option, either
delete the enabling portion of the proposed publication, or withhold publication
for an additional sixty (60) days until U.S. patent filings are completed, but
only to the extent that Sponsor agrees to reimburse University
5
for costs associated with filing, prosecuting and maintaining such patent
applications.
9. PATENT RIGHTS
A. Sole Sponsor Inventions - All rights to inventions or
discoveries conceived solely by Sponsor shall belong to Sponsor.
B. Sole University Inventions - All rights to inventions or
discoveries conceived solely by University and arising from research conducted
under this Research Agreement shall belong to the University.
C. Joint Inventions - All rights to inventions or discoveries
conceived jointly by University and Sponsor arising from research conducted
under this Research Agreement shall be jointly-owned in accordance with the U.S.
laws of inventorship.
The University shall offer to the Sponsor, in accordance with the
provisions of the following paragraph, a time-limited right to negotiate an
exclusive, worldwide, sublicensable, royalty-bearing license under the
University's interest in Sole University Inventions and Joint Inventions, to
make, use, sell, offer for sale and import products incorporating or using any
Sole University or Joint Invention conceived and first actually reduced to
practice in the performance of research under this Research Agreement, for the
term of any patent thereon.
6
In the event that an invention is conceived, but not sufficiently
reduced to practice for patent application filing during the term of this
Agreement, Sponsor is hereby granted (I)the right to fund any additional
research that may be necessary or appropriate to develop the invention
sufficiently for patent filing, exercisable as provided in paragraph 9 of this
Agreement, and (ii)if Sponsor provides such funding, the exclusive option,
exercisable as provided in paragraph 9 of this Agreement, to obtain an
exclusive, worldwide, sublicensable, royalty-bearing license to make, use, sell,
offer for sale and import products incorporating or using such invention.
The University shall promptly disclose to the Sponsor any Sole
University or Joint inventions arising under this Research Agreement. The
Sponsor shall hold such disclosure on a confidential basis and will not disclose
the information to any third party without consent of the University. The
Sponsor shall advise the University in writing within sixty (60) days of
disclosure to the Sponsor whether or not it wishes to secure an exclusive,
worldwide, sublicensable, royalty-bearing license under such invention. If the
Sponsor elects to secure a license, the University shall not offer such
opportunity to license such invention to any third party while the University
and Sponsor are negotiating such license. The Sponsor shall have six (6) months
from the date of election to conclude a license or option agreement with the
University. Such period may be extended by mutual agreement. Said license shall
contain commercially reasonable terms typically contained in license agreements
pertaining to
7
inventions of similar nature and market potential, shall require diligent
performance by the Sponsor for the timely commercial development and marketing
of such inventions and shall require the Sponsor to reimburse the University all
costs of filing, prosecuting and maintaining patent applications and patents
claiming such inventions, whether or not patents issue from such applications.
If the University and Sponsor do not conclude a license agreement prior
to the expiration of the foregoing six (6) month negotiation period, the
University may then offer to third parties the opportunity to obtain a license
to such inversion. If, within one year after the expiration of the negotiation
period, the University and a third party negotiate terms of a license which are
acceptable to the University, then the University shall, before executing such
license agreement with such third party, first offer Sponsor a license on the
same terms, provided such terms are more favorable to such third party than
those last offered to Sponsor. Sponsor may review such terms for thirty (30)
days after receiving such offer, during which time University shall not conclude
such license with such third party. If Sponsor notifies the University that it
desires to obtain a license on such terms, the University shall grant such
license to Sponsor and not to such third party. If Sponsor elects not to secure
such license(s) during such thirty (30) day period, all rights to the
Invention(s) disclosed hereunder shall be disposed of in accordance with
University policies, with no further obligation to Sponsor.
8
The University shall file, prosecute and maintain all patent
applications and patents claiming Sole University Inventions or Joint
Inventions, using counsel mutually agreed upon by the parties for so long as the
Sponsor reimburses the University for costs thereof. The University shall
provide copies of any documents filed with the U.S. Patent and Trademark Office
(or the foreign equivalent thereof) to Sponsor in advance of the filing of such
documents with the appropriate authority, and agrees to consult with and
consider the comments of Sponsor regarding the contents of such filings. The
University shall also reasonably cooperate with Sponsor in obtaining patent
protection for Sole University Inventions or Joint Inventions in all foreign
countries designated by Sponsor. Sponsor may notify the University if it intends
to cease reimbursing the University for patent-related expenses by providing at
least ninety (90) days prior written notice, in which case the University shall
have the right, but not the obligation to continue to file, prosecute and
maintain such patent protection at the University's expense.
10. INDEMNIFICATION - Sponsor agrees to defend, indemnify and hold
University harmless from and against any and all liability, loss, expense,
reasonable attorneys' fees, or claims for injury or damages arising out of the
performance of this Agreement, but only in proportion to and to the extent such
liability, loss, expense, attorneys' fees, or claims for injury or damages are
caused by or result from the negligent or intentional acts or omissions of
Sponsor, its officers, agents or employees. If human subjects are
9
involved, subject to University policy regarding care of such human subjects,
Sponsor also agrees to be responsible for the costs of providing medical care to
any subject injured as a result of his or her participation in the research
conducted under this Agreement.
University agrees to defend, indemnify and hold Sponsor harmless from
any claim, liability, loss, expense, reasonable attorneys' fees, or claims for
injury or damages arising out of the performance of this Agreement, but only in
proportion to and to the extent such liability, loss, expense, attorneys' fees,
or claims for injury or damages are caused by or result from the negligent or
intentional acts or omissions of University, its officers, agents, or employees.
11. SUPPLIES AND EQUIPMENT - In the event that University purchases
equipment hereunder, title to such equipment shall vest in University.
12. EXCUSABLE DELAYS - In the event of a delay caused by inclement weather,
fire, flood, strike or other labor dispute, act of God, act of governmental
officials or agencies, or any other cause beyond the control of University,
University shall be excused from performance hereunder for the period of time
attributable to such delay, which may extend beyond the time lost due to one or
more of the causes mentioned above for a reasonable period of time, provided
that the University uses reasonable efforts to overcome the cause of any such
delay. In the event of any such delay, this
10
Agreement may be revised by changing the Budget, performance period and other
provisions, as appropriate, by mutual agreement of the parties.
13. NOTICE - Whenever any notice is to be given hereunder, it shall be in
writing and sent to the following address, or such other address as a party may
designate from time to time by written notice to the other party:
University: Xxxxxx X. Xxxxxxx
Contract and Grant Officer
Office of Contract and Grant Admin., 9034
University of California, San Diego
0000 Xxxxxx Xxxxx
Xx Xxxxx, XX 00000-0000
(for express mail:
UCSD Contracts and Grants
00000 X. Xxxxxx Xxxxx Xxxx, 0xx Xxxxx
Xx Xxxxx, XX 92037)
Sponsor: Dynavax Technologies Corporation
000 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000-0000
Attention: Xxx Xxxxxxx
Fax: (000) 000-0000
14. TERMINATION - Either party may terminate this Agreement for material
breach by the other party, if such breach remains uncured for sixty (60) days
after the breaching party receives notice of such breach from the nonbreaching
party. Written notice shall be directed to the appropriate individual named in
Article 13 ("NOTICE") of this Agreement. Upon the giving of notice of
termination by either party, the University shall exert its best efforts to
limit or terminate any outstanding commitments. Sponsor
11
shall reimburse University for all costs incurred by it for all work performed
through the effective termination date, and for all outstanding obligations
which cannot be canceled. Such obligations may include salary and fringe
benefits (including vacation accrual) of personnel engaged on the project during
their severance period; purchase orders and other agreements with outside
vendors which cannot be canceled; inventory storage and disposition costs for
items produced under this Agreement; and indirect costs associated with these
obligations. In addition, in the event of termination by Sponsor, University
shall also be reimbursed for additional costs which may be incurred as a result
of termination, including reasonable clerical and accounting costs. Support for
any graduate students employed by the project are noncancellable. University
shall furnish, within ninety (90) days of the effective date of termination, a
final invoice for settlement of all costs to be reimbursed.
15. GOVERNING LAW. - This Agreement is made in accordance with, and shall
be governed and construed under the laws of the State of California, excluding
its choice of law rules.
16. SEVERABILITY, - In the event any provision of this Agreement is held to
be invalid or unenforceable, the valid or enforceable portion thereof and the
remaining provisions of this Agreement will remain in full force and effect.
17. ENTIRE AGREEMENT. - This Agreement and the exhibit attached
12
hereto constitute the entire, final, complete and exclusive agreement between
the parties and supersede all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement. This Agreement may
not be modified or amended except in a writing signed by a duly authorized
representative of each party.
THE REGENTS OF THE UNIVERSITY OF DYNAVAX TECHNOLOGIES
CALIFORNIA CORPORATION
By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxx X. Xxxxxx
---------------------------- ------------------------
(Signature) (Signature)
Name: Xxxxxx X. Xxxxxxx Name: Xxxxxx X. Xxxxxx
Title: Contract & Grant Officer Title: President
Date: November 15, 1996 Date: 11/22/96
13
AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT TO LICENSE AGREEMENT is made this 23rd day of
July, 1997, between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a California
corporation, having statewide administrative headquarters at 000 Xxxxxxxx Xxxxx,
00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx, 00000-0000, hereinafter referred to as "The
Regents," and Dynavax Technologies Corporation, a California corporation, having
an address at 0000 Xxxxxxx Xxxx Xxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000,
hereinafter referred to as the "Licensee."
WHEREAS, The Regents and the Licensee entered into a License
Agreement, dated the 26th day of March 1997, (UC Control No. 97-04-0493) for
Method, Compositions and Devices for Administration of Naked Nucleotides Which
Express Biologically Active Peptides (UC Case No. 92-296) and Immunostimulatory
Oligonucleotide Conjugates (UC Case No. 97-138-1), owned by The Regents;
NOW, THEREFORE, upon execution of this Agreement, it is agreed
between the parties to amend the License Agreement.
I. Paragraph 9.1 is amended to read as follows:
9.1 The Licensee shall sponsor research in the laboratory of Xxxxx
Xxxxxx Xxxxxx, Ph.D., at the University of California San Diego, and
such sponsored research will be for a two (2) year period of not
less than [***] (including direct and indirect costs), pursuant to
the research agreement between The Regents of the University of
California and Licensee dated November 22, 1996, which is attached
as Exhibit "A" ("Research Agreement").
* * * * * * * * * *
IN WITNESS WHEREOF, the parties hereto have executed this
Agreement by their respective officers hereunto duly authorized, the day and
year hereinafter written.
DYNAVAX TECHNOLOGIES THE REGENTS OF THE
CORPORATION: UNIVERSITY OF CALIFORNIA:
By: /s/ Dino Dina By: /s/ Xxxxx X. Xxxxxx
--------------------------------- -------------------------
(signature)
Name: Dino Dina, M.D. Name: Xxxxx X. Xxxxxx
Title: President Title: Licensing Associate
Office of Technology Transfer
Date: July 17, 1997 Date: 7-23-97
Approved as to legal form: /s/ Xxxxx Xxxxxxx 7/10/97
------------------------------------
Xxxxxx X. Xxxxxxx Date
University Counsel
Office of General Counsel
[***]=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.
FIRST AMENDMENT TO LICENSE AGREEMENT
This amendment ("Amendment") is effective this 2nd day of
October, 1998, between The Regents Of The University Of California, a California
corporation, having statewide administrative headquarters at 0000 Xxxxxxxx
Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx, 00000-0000, hereinafter referred to as
"The Regents," and Dynavax Technologies Corporation, a California corporation,
having an address at 000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxxxx 00000,
hereinafter referred to as the "Licensee."
WHEREAS, The Regents and the Licensee entered into a license agreement,
dated the 26th day of March, 1997 (UC Control No. 97-04-0493) for Method,
Compositions and Devices For Administration of Naked Nucleotides Which Express
Biologically Active Peptides, for certain patent applications covered by UC Case
No. 92-296, and owned by The Regents and for Immunostimulatory Oligonucleotide
Conjugates, UC Case No. 97-138 and owned by The Regents ("License Agreement"),
WHEREAS, The parties wish to include additional patent applications
filed since the date of the License Agreement in the License Agreement,
NOW, THEREFORE, upon execution of this Amendment, it is agreed between
the parties to amend the License Agreement.
I. Paragraph 1.1 is deleted in its entirety and replaced with the
following:
1.1 "Regents' Patent Rights" means any subject matter claimed or
disclosed in any of the following:
U.S. Patent Application Serial
Case Number Number Filing Date
----------- ------------------------------ ----------------------------
92-296-1 Serial No. 08/112,440 August 26, 1993 (now
abandoned)
92-296-2 Serial No. 08/464,878 June 7, 1995; claims allowed
September 16, 1997
92-296-3 Serial No. 08/333,068 November 1, 1994
92-296-4 Serial No. 08/334,260 November 3, 1994
92-296-5 [***] [***]
92-296-6 [***] [***]
92-296-7 [***] [***]
92-296-8 [***] [***]
[***] = 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.
92-296-9 [***] [***]
92-296-A Serial No. 08/593,554 January 30, 1996
92-296-B Serial No. 08/725,968 October 4, 1996
92-296-C Serial No. 08/927,120 September 5, 1997
92-296-D Serial No. 08/928,412 September 12, 1997
92-296-E Application authorized September 30, 1997
92-296-F Application authorized September 29, 1997
97-138-1 Serial No. 60/028,118 October 11, 1996
97-138-2 Serial No. 08/927,120 September 5, 1997
by Drs. Xxxxxx X. Xxxxxx, Xxxx Xxx and Xxxxxxxx Xxxxxx and assigned to The
Regents; and continuing applications thereof, divisions, substitutions, and
continuation-in-part applications, but only to the extent claims in any such
continuation-in-part application contain subject matter included in the
foregoing listed applications as originally filed in the U.S. Patent and
Trademark Office ("USPTO"); any patents issuing on said applications including
reissues, reexaminations and extensions; and any corresponding foreign
applications or patents (including inventor's certificates)."
* * * * * * * * * *
IN WITNESS WHEREOF, the parties hereto have executed this Amendment by their
respective officers hereunto duly authorized, the day and year hereinafter
written.
DYNAVAX TECHNOLOGIES THE REGENTS OF THE
CORPORATION UNIVERSITY OF CALIFORNIA
By: /s/ Dino Dina By: /s/ Xxxxxxx X. Xxxxxxxxx
------------------------- ----------------------------
(Signature) (Signature)
Name: Dino Dina, M.D. Name: Xxxxxxx X. Xxxxxxxxx
Title: President & CEO Title: Executive Director
Office of Technology Transfer
Date: September 25, 1998 Date: 10-2-98
Approved as to legal form: /s/ Xxxxx X. Xxxxx 9/8/99
-----------------------------
Xxxxx X. Xxxxx Date
University Counsel
Office of General Counsel
[***] = 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.
UC Case Nos. 92-296 and 97-138
THIRD AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This third amendment (the "Third Amendment") is effective this 22nd day
of September, 1999 (the "Effective Date") between The Regents of the University
of California, a California corporation with administrative headquarters at 0000
Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000 ("The Regents"), and
Dynavax Technologies Corporation, a California corporation, having an address at
000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxxxx 00000, ("Dynavax").
BACKGROUND
A. The Regents and Dynavax entered into an exclusive license agreement
(UC Control No. 97-04-0493) dated March 26, 1997 ("the Agreement") which covers
"Methods, Compositions, and Devices for Administration of Naked Nucleotides
Which Express Biologically Active Peptides" and "Immunostimulatory
Oligonucleotide Conjugates".
B. The Regents and Dynavax entered into other exclusive license
agreements. These are UC Agreement Control Nos. 99-04-0166 and 99-04-0321, dated
October 2, 1998 (the "UC 94-029 Agreement" and "UC 97-287 Agreement",
respectively) which cover "Compounds for Inhibition of Ceramide-mediated Signal
Transduction" and "New Anti-inflammatory Inhibitors: Inhibitors of Stress
Activated Protein Kinase Pathways"; and "Inhibitors of DNA Immunostimulatory
Sequence Activity," respectively.
C. This Agreement was amended July 23, 1997, to change the Principle
Investigator listed in the Research Agreement dated November 22, 1996.
D. This Agreement was amended October 2, 1998, to include additional
patent applications in the definition of Regents' Patent Rights.
1
E. The Regents and Dynavax wish to further amend this Agreement to
include additional patent applications filed since the Effective Date in the
definition of Regents' Patent Rights.
F. The Regents and Dynavax wish to further amend this Agreement to
amend the Index Milestone Payment, and
G. The Regents and Dynavax wish to further amend this Agreement to
amend the Attributed Income Payment to take into consideration amounts which may
be or have been paid under the UC 94-029 Agreement and the UC 97-287 Agreement.
NOW, THEREFORE, the parties agree to amend the Agreement as set forth
herein.
Paragraph 1.1 is deleted in its entirety and replaced with the following:
1.1 "Regents' Patent Rights" means any subject matter claimed or
disclosed in any of the following:
Case Number U.S. Patent Application Serial Filing Date or Issue Date
Number or U.S. Patent Number
-------------------------------- ------------------------------ -------------------------
92-296-1 Serial No. 08/112,440] August 26, 1993
92-296-2 Patent No. 5,830,877 November 3, 1998
92-296-3 Patent No. 5,804,566 September 8, 1998
92-296-4 Patent No. 5,679,647 October 21, 1997
92-296-5 [***] [***]
92-296-6 [***] [***]
92-296-7 [***] [***]
92-296-8 [***] [***]
92-296-9 [***] [***]
92-296-A Serial No. 08/593,554 January 30, 1996
92-296-B Patent No. 5,849,719 December 15, 1998
92-296-C Serial No. 08/927,120 September 5, 1997
92-296-D Serial No. 08/928,412 September 12, 1997
92-296-G Serial No. 09/212,064 September 15, 1998
92-296-H Serial No. 09/235,742 January 21, 1999
97-138-1 Serial No. 60/028,118 October 11, 1996
97-138-2 - incorp. into 92-296-C Serial No. 08/927,120 September 5, 1997
97-138-3 Serial No. PCT/US97/19004 October 9, 1997
[***] = 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
by Drs. Xxxxxx X. Xxxxxx, Xxxx Xxx and Xxxxxxxx Xxxxxx and assigned to The
Regents; and continuing applications thereof, divisions, substitutions, and
continuation-in-part applications, but only to the extent claims in any such
continuation-in-part application contain subject matter included in the
foregoing listed applications as originally filed in the U.S. Patent and
Trademark Office ("USPTO"); any patents issuing on said applications including
reissues, reexaminations and extensions; and any corresponding foreign
applications or patents (including inventor's certificates).
Paragraph 8.3 is deleted in its entirety and replaced with the following:
8.3 Indexed Milestone Payment: Within sixty (60) days of either
(a) the closing of a public offering of the common stock pursuant to a
registration statement filed with the Securities and Exchange Commission or (b)
any consolidation or merger of Dynavax with any other entity, or any other
corporate reorganization following which the shareholders of Dynavax immediately
prior thereto own less than sixty percent (60%) of Dynavax's voting power, or
any transaction or series of transactions in which greater than forty percent
(40%) of Dynavax's voting power is transferred to a third party not previously a
shareholder of Dynavax; Dynavax shall make to The Regents a cash payment equal
to [***]. This Indexed Milestone Payment shall be a one-time payment by Dynavax
under any one of the three (3) license agreements between The Regents and
Dynavax. One third (1/3) of this amount will be attributed to this Agreement,
one third (1/3) to the UC 94-029 Agreement, and one third (1/3) to the UC 97-287
Agreement.
Paragraph 8.4 is deleted in its entirety and replaced with the following:
8.4 Attributed Income: Within sixty (60) days of Dynavax's receipt
of Attributed Income, Dynavax shall pay to The Regents [***]. Such Attributed
Income shall be allocated to the license agreement that generated the Attributed
Income. These payments by Dynavax shall continue until an aggregate of [***] has
been paid by Dynavax under the three (3) license agreements between The Regents
and Dynavax.
[***] = 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.
3
Paragraph 9.5.3 is deleted in its entirety and replaced with the following:
9.5.3 market Licensed Products [***];
The following Paragraph 9.6 is added:
9.6 If Dynavax is unable to meet any of the dates set forth in
Paragraph 9.5, Dynavax shall be entitled to a one-time extension of each of the
dates (which have not been met) by [***] upon payment of [***] to The Regents,
provided that such payments is received by The Regents within sixty (60) days of
receipt of written notice by The Regents that Dynavax has not met a due
diligence date. The [***] payment has the effect of extending the subject date
and all subsequent dates by [***]. The Regents shall not exercise its rights to
terminate this Agreement unless a re-established date is not met.
The remaining provisions of the Agreement remain in full force and
effect.
The parties have executed this Third Amendment in duplicate by their
respective and duly authorized officers, as evidenced by the signatures below.
DYNAVAX TECHNOLOGIES THE REGENTS OF THE
CORPORATION: UNIVERSITY OF CALIFORNIA:
By: /s/ Dino Dina By: /s/ Xxxxxxx X. Xxxxxxxxx
----------------------------- ---------------------------
(signature) (signature)
Name: Dino Dina, M.D. Name: Xxxxxxx X. Xxxxxxxxx
Title: President & CEO Title: Executive Director
Research Administration and
Technology Transfer
Date: Sept. 17 1999 Date: 9-22-99
Approved as to legal form: /s/ Xxxxx X. Xxxxx 9/8/99
-------------------------------
Xxxxx X. Xxxxx Date
University Counsel
Office of General Counsel
[***] = 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.
4