[***]=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 10.7
DEVELOPMENT COLLABORATION AGREEMENT
This Development Collaboration Agreement ("AGREEMENT") is made and
effective as of June 10, 2003 (the "EFFECTIVE DATE"), by and between BioSeek,
Inc., a California corporation, having a place of business at 000-X Xxxxxx Xxxx,
Xxxxxxxxxx, Xxxxxxxxxx 00000 ("BIOSEEK") and Dynavax Technologies Corporation, a
Delaware corporation, having a place of business at 000 Xxxxxx Xxxxxx, Xxxxx
000, Xxxxxxxx, Xxxxxxxxxx 00000 ("DYNAVAX").
BACKGROUND
A. BioSeek has developed certain technology known as BioMAP
Technology (as defined below) that is used to perform, among other things,
biofunctional characterization of genes and potential therapeutic compounds, as
further described in this Agreement;
B. Dynavax is engaged in research and development of certain
proprietary compounds for potential human therapeutic use, as further described
in this Agreement;
C. Dynavax and BioSeek desire that BioSeek apply the BioMAP
Technology to analyze and characterize the activity of certain compounds with
the objective of advancing the development of such compounds, and the parties
desire to enter into this Agreement to enable them to engage in such activities.
Now, therefore, in consideration of the mutual covenants and conditions
contained herein, and intending to be legally bound, the parties agree as
follows:
1. DEFINITIONS.
(a) "AFFILIATE" means, with respect to a particular party,
another person that controls, is controlled by or is under common control with
such party. For the purposes of the definition in this Section 1(a), the word
"control" (including, with correlative meaning, the terms "controlled by" or
"under the common control with") means the actual power, either directly or
indirectly through one or more intermediaries, to direct or cause the direction
of the management and policies of such entity, whether by the ownership of at
least fifty percent (50%) of the voting stock of such entity, or by contract or
otherwise.
(b) "BioMAP TECHNOLOGY" means BioSeek's proprietary human
cell-based model systems technology as more fully described in Exhibit 1(b).
(c) "CONFIDENTIAL INFORMATION" means, in the case of Dynavax,
information disclosed by Dynavax to BioSeek concerning the identity of the
Provided TZP Compounds, their development status, results of preclinical assays
and requirements for their handling and safety ("DYNAVAX CONFIDENTIAL
INFORMATION"), and in the case of BioSeek, information disclosed to Dynavax
concerning the BioMAP Technology or otherwise related to BioSeek's performance
of the Program ("BioSEEK CONFIDENTIAL INFORMATION"), that, in either case, if
disclosed in tangible form is marked "Confidential" or with other similar
designation to indicate its confidential or proprietary nature, or if disclosed
orally is indicated orally to be confidential or proprietary by the disclosing
party at the time of disclosure and is confirmed in writing as confidential or
proprietary by the disclosing party within a reasonable time after such
disclosure.
(d) "DERIVATIVE" means any compound that is derived from
another compound. As used in this Section 1(d), a compound shall be considered a
"Derivative" of a precursor compound if it either:
(1) is actually synthesized in a chemical synthesis
program based on the precursor compound; or
1
(2) is actually synthesized based on
structure-activity data relating to the precursor
compound; or
(3) was made in the course of further advancing one
or more precursor compounds toward
commercialization; or
(4) is included within the scope of any claim of a
patent application or patent which also claims
one or more precursor compounds and/or compounds
described in (1) through (3) above.
(e) "DYNAVAX PARTNER" means a third party with whom Dynavax
has entered into a Partnering Agreement.
(f) "FDA" means the United States Food and Drug
Administration.
(g) "IND" means an Investigational New Drug application, as
defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, for initiating clinical trials in the United States.
(h) "NET SALES" means the total amount invoiced to
non-Affiliate third parties on sales of TZP Products by Dynavax, Dynavax's
Partners, and the Affiliates and sublicensees of each, less the following
reasonable and customary deductions allowed to the buyer against the invoiced
amount: (i) trade, cash and quantity discounts; (ii) amounts for claims,
allowances or credits for returns; and (iii) prepaid freight, sales taxes,
duties and other governmental charges (including value added tax) on particular
sales, but excluding what is commonly known as income taxes, in each case if
charged separately on the invoice and paid by the customer. For the removal of
doubt, Net Sales shall not include sales to Dynavax, Dynavax's Partners, and the
Affiliates and sublicensees of each for resale; however, sales to such entities
shall be treated as Net Sales at list price. A "sale" shall also include a
transfer or other disposition for consideration other than cash, in which case
such consideration shall be valued at the fair market value thereof.
(i) "NOVEL MARKER" means a measurement or profile of a
biological or biochemical analyte that indicates the activity of one or more of
the TZP Compounds in a manner that is relevant to a mechanism of action of such
TZP Compound in a particular disease state, which measurement or profile has not
been, as of the date it is identified by BioSeek, or by Dynavax based on the
Profiling Results, (i) disclosed as a marker for such purpose in the public
domain as a result of prior publication or use, or (ii) identified as a marker
for such purpose by Dynavax without use of any Profiling Results, which Dynavax
shall have the burden of demonstrating with competent evidence.
(j) "PARTNERING AGREEMENT" means any agreement, arrangement or
understanding between Dynavax and a third party under which Dynavax grants to
the third party, directly or indirectly, any right or option to market, sell,
distribute or otherwise commercialize a TZP Product in any geographic territory.
(k) "PHASE III TRIAL" means that portion of the clinical
studies for the FDA submission and approval process which provides for trials of
a product on sufficient numbers of patients to establish the safety and efficacy
of such product to support regulatory approval in the proposed therapeutic
indication as more fully defined in 21 C.F.R. Section 312.21(c).
(l) "PROFILING RESULTS" means the profiling information
regarding the Provided TZP Compounds obtained as a result of BioSeek's
performance of the Program.
-2-
(m) "PROGRAM" means the activities conducted or to be
conducted by BioSeek under Section 2 of this Agreement in analyzing the Provided
Compounds using the BioMAP Technology, with the objective of achieving the
Target Milestone.
(n) "PROVIDED TZP COMPOUNDS" means those TZP Compounds
specified in Exhibit 1(n) or otherwise provided by Dynavax to BioSeek in
connection with the Program.
(o) "TARGET MILESTONE" means the accomplishment by BioSeek of
[***].
(p) "THIRD-PARTY FINANCING" means Dynavax's closing of its
first financing after the Effective Date in which Dynavax receives cash through
the sale of its debt or equity securities, other than (i) the sale of its equity
or debt securities to a corporate partner in connection with and as part of a
product licensing transaction for other than a TZP Product, to the extent the
amount invested is to be applied to support development of such product by
Dynavax, or (ii) the sale of shares through exercise of options granted to
employees or consultants under stock option plans or exercise of warrants
outstanding on the Effective Date.
(q) "TZP COMPOUND" means any compound within the scope of one
or more of the following clauses (i) or (ii): (i) any compound within the scope
of any claim, as published 23 November 2000, of PCT publication No. WO 00/69861,
and any Derivative thereof; or (ii) any compound provided by Dynavax pursuant to
this Agreement, and any Derivative thereof.
(r) TZP PRODUCT" means a product that incorporates or utilizes
one or more TZP Compounds.
(s) "UC AGREEMENT" means that certain Exclusive License
Agreement between The Regents of the University of California and Dynavax, dated
October 2, 1998, as amended September 22, 1999.
2. THE PROGRAM.
(a) Within ten (10) days after the Effective Date, Dynavax
will provide to BioSeek, at no charge to BioSeek, such reasonable quantities of
the TZP Compounds specified in Exhibit 1(n) as BioSeek may require under this
Section 2. BioSeek shall in its discretion perform such research and development
activities as it deems appropriate in its efforts to achieve the Target
Milestone. Dynavax shall also provide BioSeek, within fifteen (15) days after
the Effective Date, information specified in Exhibit 2(a), and Dynavax shall
provide technical advice concerning the handling and preparation of the Provided
Compounds. BioSeek and Dynavax shall each appoint a project leader to coordinate
activities under this Agreement and to act as the primary contact and source of
information on the Provided Compounds and the Program. Either party may change
its designated project leader by written notice to the other party.
(b) Dynavax will provide BioSeek with a Material Safety Data
Sheet for the Provided TZP Compounds and any additional available information
concerning the safety, handling, use, disposal and environmental effects of the
Provided TZP Compounds as may be necessary to conduct the Program. BioSeek shall
use the Provided TZP Compounds solely for the limited and express purpose of
conducting the Program. Without limiting the foregoing, the Provided TZP
Compounds will not be used in humans. Upon
[***]=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-
completion or termination of the Program, at Dynavax's request, BioSeek shall
return any unused portions of the Provided TZP Compound.
3. MILESTONE PAYMENT.
As compensation for performance of the Program, Dynavax shall [***]
within 30 days after receiving notice from BioSeek of its achievement of the
Target Milestone (the "MILESTONE PAYMENT"), subject to the following:
If the Target Milestone is first achieved at a time at which Dynavax has neither
(i) entered into a Partnering Agreement with a third party for a TZP Product,
nor (ii) filed an IND for a TZP Product, nor (iii) closed a Third Party
Financing, then Dynavax's obligation to pay the Milestone Payment shall be
considered deferred until 30 days following the first to occur of (i), (ii) or
(iii).
4. PARTNER INCOME AND OTHER PAYMENTS.
If BioSeek achieves the Target Milestone, then as further
compensation for the performance of the Program Dynavax shall pay to BioSeek the
following:
(a) If the first Partnering Agreement is entered into before
the filing of an IND(s) for a TZP Product, Dynavax shall pay BioSeek:
(i) [***], up to a maximum aggregate payment of
[***]; and
(ii) A royalty of [***].
(b) If the first Partnering Agreement is entered into after
the filing of an IND(s) and before the initiation of Phase III Trial(s) for a
TZP Product, Dynavax shall pay BioSeek:
(i) [***], up to a maximum aggregate payment of
[***]; and
(ii) A royalty of [***].
(c) If Dynavax does not enter into a Partnering Agreement
prior to the initiation of Phase III clinical studies of a TZP Compound, then
Dynavax shall pay BioSeek:
(i) [***] upon the initiation of a Phase III
Trial for such TZP Product;
[***]=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-
(ii) [***] upon the first commercial sale of such
TZP Product; and
(iii) A royalty of [***].
(d) For purposes of this Section 4, the "initiation of Phase
III clinical studies" shall mean the enrollment of patients and commencement of
treatment of patients in such studies. Notwithstanding the foregoing provisions
of this Section 4, if Dynavax initially enters into a Partnering Agreement
during the time period specified in Section 4(a) or 4(b), and such Partnering
Agreement does not include the grant of rights in the United States, and Dynavax
subsequently enters into a Partnering Agreement granting rights to the United
States during the time specified in Section 4(b), or initiates Phase III
clinical trials prior to entering into a Partnering Agreement granting rights to
the United States, then at the time such subsequent Partnering Agreement is
entered into, [***].
(e) If Dynavax enters into any Partnering Agreement that
either party believes is not contemplated or reasonably addressed by the
provisions of this Section 4, the parties shall confer in good faith to
determine whether any adjustment to the provisions of this Agreement is
appropriate to address such Partnering Agreement and achieve the intent of the
parties. If after the date of this Agreement, Dynavax enters into a Partnering
Agreement with a third party for a new research and development program, the
objective of which is to develop products incorporating TZP Compounds for new
therapeutic indications that function by different mechanisms of action than
those identified by BioSeek in accomplishing the Target Milestone ("New Use
Compounds"), Dynavax shall so notify BioSeek in writing. Any payments made to
Dynavax under such a Partnering Agreement that are reasonably allocable to such
new research and development or to commercialization rights to any resulting New
Use Compounds [***].
5. PAYMENTS AND REPORTS.
(a) NET PARTNERING INCOME AND NET REPORTS; PAYMENTS. Dynavax
shall forward to BioSeek a copy of any and all Partnering Agreements within 15
days after execution by the parties. Until such time as the aggregate amounts
specified in Sections 4(a) and 4(b), as applicable, have been paid to BioSeek,
Dynavax shall make quarterly written reports to BioSeek within sixty (60) days
after the end of each calendar quarter, stating in each such report the amounts
of and basis for any payments or other consideration received under each
Partnering Agreement, and including the number, description, and aggregate Net
Sales of each TZP Product sold during the calendar quarter; provided however,
that Dynavax's reporting of Net Sales during such quarter may be extended to
coincide with any longer reporting period included in the terms of the relevant
Partnering Agreement, and provided further that Dynavax shall use best efforts
to obtain such reports during such 60-day period. Simultaneously with the
delivery of each such report, Dynavax shall pay to BioSeek the total Net
Partnering Income and share of Net Sales, if any, due to BioSeek for the period
of such report.
(b) PAYMENT METHOD. All amounts payable under this Agreement
shall be made by bank-wire transfer in immediately available funds to an account
designated by BioSeek. All payments hereunder shall be made in U.S. dollars. Any
payments or portions thereof due hereunder which are not paid by the date such
payments are due under this Agreement shall bear interest equal to the lesser
one and one half percent (1 1/2%) per month, or the maximum rate permitted by
law, calculated on the number of days such payment is delinquent. This Section
5(b) shall in no way limit any other remedies available to BioSeek.
[***]=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.
-5-
(c) CURRENCY CONVERSION. If any currency conversion is
required in connection with the calculation of any amounts payable under this
Agreement, such conversion shall be made using the standard procedure adopted
and consistently applied by Dynavax in accordance with U.S. generally accepted
accounting practices. In the absence of such a standard Dynavax procedure, such
conversion shall be made using the selling exchange rate for conversion of the
foreign currency into U.S. Dollars, quoted for current transactions reported in
The Wall Street Journal for the last business day of the calendar quarter or
calendar year, as the case may be, to which such payment pertains.
(d) RECORDS; INSPECTION. Dynavax, Dynavax's Partners, and the
Affiliates and sublicensees of each shall keep complete, true and accurate books
of account and records for the purpose of determining the amounts payable under
this Agreement. Such books and records shall be kept reasonably accessible for
five (5) years following the end of the calendar quarter to which they pertain.
Dynavax shall make all such records available for inspection during such five
(5)-year period by a representative or agent of BioSeek for the purpose of
verifying amounts payable hereunder (including royalty statements). To the
extent that Dynavax does not have the right to grant BioSeek the right to audit
the books and records of Dynavax's Partners, the Affiliates of Dynavax's
Partners, or the sublicensees of Dynavax or Dynavax's Partners, hereunder,
Dynavax shall use best efforts to obtain for itself such rights and, at the
request of BioSeek, shall exercise such audit rights and provide the results of
such audit for inspection by BioSeek pursuant to this Section 5(d). BioSeek
shall bear the costs and expenses of inspections conducted under this Section
5(d), unless a variation or error producing an underpayment in royalties payable
exceeding five percent (5%) of the amount paid for any period covered by the
inspection is established in the course of any such inspection, whereupon all
reasonable out-of-pocket costs paid to third parties relating to the inspection
and any unpaid amounts that are discovered will be paid by BioSeek, together
with interest on such unpaid amounts at the rate specified in Section 5(b)
above.
6. CONFIDENTIALITY.
(a) CONFIDENTIALITY. BioSeek agrees that it shall maintain in
strict confidence all Dynavax Confidential Information, and Dynavax agrees that
it shall maintain in strict confidence all BioSeek Confidential Information,
using efforts no less diligent than such party uses to maintain the
confidentiality of its own proprietary or confidential information. In addition
to the foregoing, except to the extent expressly permitted by this Agreement,
each party (i) agrees not to disclose, use, or grant the right to use
Confidential Information of the other party to any third party without the prior
written consent of such other party, and (ii) will only disclose, use or grant
the use of such Confidential Information of the other party to those personnel,
collaborators, consultants, or Affiliates of such party who are bound by similar
obligations of confidentiality as those set forth herein and only to the extent
they require access thereto to perform the activities contemplated herein. In
addition to the foregoing, provided Dynavax gives BioSeek reasonable advance
written notice and BioSeek provides its written consent, which shall not be
unreasonably withheld, Dynavax may disclose to parties with whom Dynavax is
considering granting commercial rights to TZP Compounds, the following BioSeek
Confidential Information: cell types and disease-related pathways activated in
the BioMAP Technology to produce Profiling Results, mechanisms of action
disclosed within the Profiling Results (but not the methodology of how the
experiments were run using such experimental conditions, the informatics and
analytical tools used to generate results, and the generation of resulting
data); provided that such collaborators or potential Partners are under similar
obligations of confidentiality as those set forth herein for such Confidential
Information.
(b) Notwithstanding anything to the contrary in this
Agreement, Confidential Information shall not include information which the
receiving party can demonstrate by competent written proof: (i) is now, or
hereafter becomes, through no act or failure to act on the part of the receiving
party, generally known or available in the public domain; (ii) is known by the
receiving party at the time of receiving such information, or is hereafter
furnished to the receiving party by a third party, in each case, as a matter of
right and without restriction on disclosure, as evidenced by its records; (iii)
is generated by the receiving party
-6-
independent of any information disclosed by the disclosing party by persons who
have not had access to or knowledge of the Confidential Information of the
disclosing party; or (iv) is the subject of a written permission to disclose
provided by the disclosing party.
(c) Notwithstanding any other provision of this Agreement,
disclosure of Confidential Information shall not be precluded to the extent such
disclosure:
(i) is in response to a valid order of a court
or other governmental body of a country or any political subdivision thereof;
provided however, that the receiving party shall give reasonable advance notice
to the disclosing party and shall have made a reasonable effort to obtain a
protective order requiring that the Confidential Information so disclosed be
used only for the purposes for which the order was issued; or
(ii) is otherwise required by law or regulation;
provided that receiving party shall give reasonable advance notice to the other
party so that reasonable efforts can be made to obtain a protective order
requiring that the Confidential Information so disclosed be used only for
purposes required under the law or regulation.
(d) Except to the extent otherwise contemplated by this
Agreement, within thirty (30) days after the expiration or termination of this
Agreement for any reason, and in the absence of a further written agreement of
the parties, each party shall destroy or return to the other party, as directed
by such party, any and all materials containing Confidential Information
received from such other party.
7. OWNERSHIP AND RIGHTS.
(a) TZP COMPOUNDS. As between the parties, all right, title
and interest in and to the Provided TZP Compounds and other TZP Compounds within
the scope of patent rights owned or exclusively licensed to Dynavax is, and will
at all times, remain the sole and exclusive property of Dynavax.
(b) BIOMAP TECHNOLOGY AND DATA. As between the parties, all
right, title, and interest in and to the BioMAP Technology and the results of
the Program is, and will at all times remain, the sole and exclusive property of
BioSeek, subject to the rights granted under Section 7(c) respecting the
Profiling Results. The parties acknowledge and agree that data included in the
Profiling Results will maintain and reside in BioSeek's database and that
BioSeek may maintain and utilize such data as part of its database provided that
(i) such data are coded in the database so that the identity of the Provided TZP
Compounds and Dynavax are not disclosed, and (ii) BioSeek will not provide such
data to other collaboration partners.
(c) PROFILING RESULTS. Upon completion of the Target
Milestone, and subject to the terms and conditions of this Agreement (including
the payment of all amounts due under this Agreement), BioSeek will grant to
Dynavax the right and license to use the Profiling Results solely for the
further research, development and commercialization of TZP Compounds and TZP
Products.
(d) NOVEL MARKERS. Notwithstanding anything to the contrary
herein, if Dynavax or a Dynavax Partner desires to use or commercialize a Novel
Marker identified by BioSeek in clinical trials for TZP Compounds or as a
diagnostic test, the right to use such Novel Marker shall not be considered
granted under Section 7(c), but Dynavax and BioSeek shall negotiate in good
faith an agreement providing for the use of such Novel Marker and providing for
additional consideration to BioSeek for the use of such Novel Marker.
(e) COOPERATION; RESTRICTION OF RIGHTS. Each party shall
cooperate with the other party, and shall obtain the cooperation of its
employees and agents, to provide, as necessary, rights set forth in this
-7-
Section 7. Nothing in this Agreement is to be construed as granting a right or
license to either party to use Confidential Information of the other party,
except as expressly provided herein.
8. INDEPENDENT CONTRACTOR. Nothing herein shall be construed to create
any relationship of employer and employee, agent and principal, partnership or
joint venture between the parties. Each party is an independent contractor.
Neither party shall assume, either directly or indirectly, any liability of or
for the other party. Neither party shall have the authority to bind or obligate
the other party and neither party shall represent that it has such authority.
9. USE OF TZP COMPOUNDS AND TECHNOLOGIES.
(a) Each party agrees to comply with all federal and state
government regulations, guidelines, laws, policies, and internal policies that
are applicable to such party's use of the TZP Compounds that are the subject of
this Agreement or the other party's Confidential Information.
(b) Each party reserves the right to distribute or disclose
compounds and Confidential Information owned by such party to others and to use
such compounds and Confidential Information owned by such party for its own
purposes.
10. DILIGENCE.
(a) Subject to continued technical feasibility and
availability of internal resources, Dynavax shall diligently endeavor, either on
its own or with a Dynavax Partner, to develop, manufacture, market, sell and
meet commercial demand for TZP Products within a commercially reasonable time
after the achievement of the Target Milestone, and to otherwise perform as
required under Section 8 of the UC Agreement. As BioSeek may request from time
to time after the achievement of the Target Milestone, Dynavax shall keep
BioSeek informed as to Dynavax's progress in meeting its obligations under this
Section 10(a). Without limiting the foregoing, Dynavax shall use commercially
reasonable efforts to perform its obligations under the UC Agreement and to
maintain the UC Agreement in full force and effect.
(b) If Dynavax determines for any reason that it will not or
cannot pursue development of TZP Products, Dynavax shall promptly notify BioSeek
of such intention in writing, and in such event, or in the event this Agreement
is terminated pursuant to Section 14(c), without limiting any rights or remedies
otherwise available to BioSeek, the parties shall, at BioSeek's request and at
its option, negotiate in good faith on a non-exclusive basis for the grant to
BioSeek of the right to develop, manufacture, market, sell, distribute and
otherwise commercialize TZP Compounds, on reasonable terms and conditions which
shall take into account the value to TZP Compound development contributed by
both Dynavax and BioSeek.
(c) Subject to continued technical feasibility and
availability of internal resources and without limiting any other provisions of
this Agreement, BioSeek shall use commercially reasonable efforts to conduct the
Program in a manner that is consistent with its goals and objectives. As Dynavax
may request from time to time, BioSeek shall keep Dynavax informed as to
Dynavax's progress in performing the work in the Program.
11. REPRESENTATION AND WARRANTY; DISCLAIMERS.
(a) REPRESENTATIONS AND WARRANTIES. Each party represents and
warrants that it has the power to enter into this Agreement and to the best of
its knowledge has the right to grant the rights granted herein to the other
party. In addition, Dynavax represents and warrants that (i) Dynavax has not
previously granted and will not grant any rights in any TZP Compounds
(including, without limitation, any intellectual property rights) that are
inconsistent with the rights and licenses granted to BioSeek herein; (ii)
subject to the UC Agreement, Dynavax is the exclusive owner of the entire right,
title, and interest in and to all TZP
-8-
Compounds (including, without limitation, all intellectual property rights
therein); (iii) Dynavax has the right to provide the Provided TZP Compounds to
BioSeek as set forth in this Agreement; (iv) Dynavax has performed as required
under the UC Agreement; and (v) the UC Agreement has not terminated, expired, or
in any way been limited, in any manner that would affect Dynavax's ability to
diligently develop, obtain market approvals for, and market any TZP Products.
BioSeek represents and warrants that it has the right to apply its BioMAP
Technology for the purposes contemplated under this Agreement.
(b) DISCLAIMERS.
DYNAVAX AND BIOSEEK MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES
WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT, EXPRESS OR IMPLIED, AND
EXPRESSLY DISCLAIM ANY IMPLIED WARRANTY OF NON-INFRINGEMENT OF ANY PATENT,
COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHT, MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE.
Dynavax acknowledges and agrees that (i) BioSeek shall not be responsible for
any claims arising from use of the Provided TZP Compounds by Dynavax or third
parties in human clinical trials, for commercial sale, or otherwise, (ii)
Dynavax assumes sole responsibility for such use, and (iii) Dynavax indemnifies
and holds harmless BioSeek for any claims or liabilities, including but not
limited to attorneys' fees, arising from such use.
12. PUBLICATION.
(a) Each party acknowledges the other party's interest in
publishing the results of the Program to obtain recognition within the
scientific community and to advance the state of scientific knowledge. Each
party also recognizes the mutual interest in obtaining valid patent protection
and in protecting business interests and trade secrets. Consequently, if (i)
BioSeek, its employees, agents or consultants wish to make a publication
regarding the use of the Profiling Results (it is understood that BioSeek will
not disclose Dynavax Confidential Information or the identity of the Provided
TZP Compounds or of Dynavax without Dynavax's prior written consent), or (ii)
Dynavax, its employees, agents or consultants wish to make a publication
regarding the use of the BioMAP Technology in connection with the TZP Compounds
(it is understood that Dynavax will not disclose any BioSeek Confidential
Information without BioSeek's prior written consent), in each case, such party
shall deliver to the other party a copy of the proposed written publication or
an outline of an oral disclosure at least thirty (30) days prior to submission
for publication or presentation. The reviewing party shall have the right (a) to
propose in good faith modifications to the publication for patent reasons, trade
secret reasons, or business reasons or (b) to request a reasonable delay in
publication or presentation to protect know-how and patentable subject matter.
(b) If the reviewing party requests a delay, the publishing
party shall delay submission or presentation for up to ninety (90) days to
enable patent applications to be filed. Upon expiration of such time period, the
publishing party shall be free to proceed with the publication or presentation.
If the reviewing party requests modifications to the publication, the publishing
party shall edit such publication to prevent disclosure of trade secrets or
proprietary business information (including Confidential Information) prior to
submission of the publication or presentation.
(c) Once a particular disclosure has been approved, either
party may disclose the information contained therein in subsequent disclosures,
including without limitation, promotions, press releases, public relations,
advertisements, or sales and marketing materials, without the need for further
approval by the other party, but may not use the other party's name or logo in
connection with such information except as expressly provided in Section 13.
13. PRESS RELEASES; PUBLICITY.
-9-
(a) The parties agree that BioSeek and/or Dynavax may issue a
press release announcing the collaboration under this Agreement, which release
shall be subject to the reasonable approval of both parties. Dynavax also
acknowledges BioSeek's interest in disclosing certain limited information
concerning its research collaborations in order to promote and develop the
BioMAP Technology. Accordingly, Dynavax agrees that BioSeek may reference
Dynavax's name in conjunction with the promotion of its technologies, and refer
to Dynavax as a research collaboration partner in BioSeek's promotions and other
communications with prospective customers or investors, solely where such
reference to Dynavax's name would not associate Dynavax with any particular
compound or product.
(b) BioSeek may disclose in summary form data from the Program
in a manner that does not reveal directly or indirectly the specific identity of
any Provided TZP Compound or the identity of Dynavax. In addition to the
foregoing, within thirty (30) days after disclosure of the Profiling Results to
Dynavax, the parties shall in good faith discuss and mutually agree upon the
particular data and information within such Profiling Results that BioSeek shall
have the right to directly reference in conjunction with Dynavax's name or logo;
it being understood that objections by a party shall be based upon their
reasonable concerns regarding disclosure of (a) information that would provide a
competitive advantage to any third party's competitors, (b) information that
would adversely reflect on the goodwill of a party and or its business, (c)
information that constitutes a trade secret or a patentable invention, (d)
information that would constitute a violation of an agreement with a third party
in existence as of the Effective Date, or (e) Confidential Information owned by
the objecting party, and not otherwise permitted to be disclosed under this
Agreement.
14. TERM; TERMINATION.
(a) The term of this Agreement begins on the Effective Date
and will continue in effect until this Agreement is terminated as provided in
this Section 14.
(b) BioSeek may terminate this Agreement, in its entirety or
solely with respect to the Program or particular portions of the Program, at any
time before BioSeek achieves the Target Milestone, upon not less than thirty
(30) days' written notice to Dynavax, due solely to BioSeek's determination,
which shall be made in good faith, that it is not technically feasible to
complete the Program (or such portion of the Program) on a commercially
reasonable basis. Dynavax may terminate this Agreement upon ninety (90) days'
written notice to BioSeek if BioSeek has not achieved the Target Milestone
within nine (9) months after the Effective Date, provided that such termination
shall not be effective if BioSeek achieves the Target Milestone during such
90-day notice period. Except as provided in this Section 14(b) or Section 14(c),
neither party shall have the right to terminate the Agreement unless the parties
mutually agree to do so in writing.
(c) Without limiting any other rights or remedies under this
Agreement, if within four years after the Effective Date, Dynavax has not (i)
entered into a Partnering Agreement respecting any TZP Compound or (ii)
initiated any clinical studies of any TZP Compound, then either BioSeek or
Dynavax may terminate this Agreement upon written notice to the other party.
Upon such termination, any rights of Dynavax to use any information or results
provided hereunder shall terminate, and BioSeek's right of negotiation under
Section 10(b) shall be triggered and shall continue in effect after such
termination.
(d) Termination of this Agreement for any reason shall not
release either party to this Agreement from any liability that, at the time of
the termination, has already accrued to the other party. In addition, the
provisions of Sections 1, 3, 4, 5, 6, 7(a), 7(b), 7(e), 10(b), 11(b), 12, 13, 14
and 15 shall survive any termination of this Agreement. Any rights and licenses
granted under Section 7(c) shall terminate upon any termination of this
Agreement.
15. MISCELLANEOUS.
-10-
(a) GOVERNING LAW. This Agreement shall be construed and
enforced in accordance with the law of the State of California without regard to
principles of conflicts of law.
(b) GENERAL. This Agreement constitutes the entire
understanding and agreement of the parties respecting the subject matter hereof
and supersedes any and all prior agreements or arrangements, written or oral,
between the parties relating thereto. This Agreement may not be amended or
supplemented in any way except by a written document signed by the party against
whom such amendment or supplement is sought to be enforced. The failure on the
part of either party to enforce, or any delay in enforcing, any right, power or
remedy that such party may have under this Agreement shall not constitute a
waiver of any such right, power or remedy, or release the other party from any
obligations under this Agreement, except by a written document signed by the
party against whom such waiver or release is sought to be enforced.
(c) ASSIGNMENT. Neither party shall assign its rights or
obligations under this Agreement, in whole or in part, by operation of law or
otherwise, without the prior express written consent of the other party;
provided, however, that either party may, without such consent, assign this
Agreement and its rights and obligations hereunder to an Affiliate or in
connection with (i) the transfer or sale of all or substantially all of its
business to which this Agreement pertains, or (ii) a merger, consolidation,
change in control or similar transaction. Any permitted assignee shall assume
all obligations of its assignor under this Agreement. Any purported assignment
or transfer in violation of this Section 15(c) shall be void.
(d) NOTICES. All notices required or permitted to be given
under this Agreement will be in writing, and may be given by (i) personal
delivery, (ii) registered first-class United States mail, postage prepaid by the
sender, return receipt requested, (iii) overnight delivery service, charges
prepaid by the sender, or (iv) via facsimile, and, in each case, addressed to
the other party at the address for such party as set forth below, and will be
effective upon receipt in the case of (i), (iii) or (iv) above, and five days
after mailing in the case of (ii) above.
If to BioSeek: BioSeek, Inc.
000-X Xxxxxx Xx.
Xxxxxxxxxx, XX 00000
Fax #: 000.000.0000
Attention: Chief Executive Officer
If to Dynavax: Dynavax Technologies Corporation
000 Xxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000-0000
Fax #000.000.0000
Attention: Chief Executive Officer
(e) SEVERABILITY. In the event that any term of this Agreement
is held to be invalid, illegal, or unenforceable, such invalidity, illegality,
or unenforceability shall not affect any other portion of this Agreement, and
there shall be deemed substituted for such invalid, illegal or unenforceable
term an alternative term as will most fully realize the intent of the parties as
expressed in this Agreement to the fullest extent permitted by applicable law.
The parties hereby declare their intent that this Agreement is to be construed
in such fashion as to maintain its existence, validity and enforceability to the
greatest extent possible.
(f) INJUNCTIVE RELIEF. Each of BioSeek and Dynavax
acknowledges that the limitations and restrictions on its possession and use of
the Confidential Information of the other party are necessary and reasonable to
protect the other party, and each party acknowledges that monetary damages could
be inadequate to compensate the other party for any violation by such party of
any such limitations or
-11-
restrictions, and that any such violation could cause irreparable injury to the
other party. BioSeek and Dynavax agree that, in addition to any other remedies
that may be available in law, in equity or otherwise, each party shall be
entitled to seek temporary and permanent injunctive relief against any
threatened violation of such limitations or restrictions or the continuation of
any such violation in any court of competent jurisdiction, without the necessity
of proving actual damages.
In witness whereof, the parties have by duly authorized persons,
executed this Agreement, as of the date first above written.
BIOSEEK DYNAVAX
By: /s/ Xxxxx X. Staple By: /s/ Dino Dina
-------------------------------- -------------------------
Title: Chief Executive Officer Title:______________________
-12-
EXHIBIT 1(b)
BioMAP TECHNOLOGY DESCRIPTION
BioMAP Technology includes; (i) the compositions (cell types, gene
products, proteins, carbohydrates, lipids, compounds) of assays for the testing
and analysis of compounds, genes, or biological samples ("BioMAP(TM) ASSAYS");
(ii) methods of measurement, instrumentation, techniques, materials, and
concepts related to the above; (iii) drug/compound effects related to the above;
(iv) drug/compound development to specific targets; (v) SDI(TM) animal model
design, testing and compound efficacy in such models; (vi) composition,
architecture and development of data, software and informatics tools regarding
the analysis of BioMap(TM) and SDI(TM) data; (vii) methods and uses of
combinatorial biology/BioMAP(TM) systems; and (viii) any improvements made of
any of the foregoing.
-13-
EXHIBIT 1(n)
TZP COMPOUNDS TO BE PROVIDED TO BIOSEEK FOR THE PROGRAM
As of the Effective Date, Dynavax shall provide the following TZP Compounds to
BioSeek for use in the Program:
[***]=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.
-14-
EXHIBIT 2(a)
INFORMATION TO BE PROVIDED BY DYNAVAX TO BIOSEEK
1. Structures of the Provided TZP Compounds
2. Data corresponding to metabolism and stability tests performed on the
Provided TZP Compounds
3. Data on biochemical assays performed on the Provided TZP Compounds
4. Summary of data corresponding to previous tests on candidate targets of the
Provided TZP Compounds including:
a. RNA
b. Cytokines
c. In vitro cellular assays
d. Responses in animal models
-15-
