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under 17 C.F.R. Sections 200.80,
200.83 and 230.406
EXHIBIT 10.43
RESEARCH COLLABORATION AGREEMENT
THIS RESEARCH COLLABORATION AGREEMENT (the "Agreement"), dated as of
________, 1996, (the "Effective Date") is entered into between SIGNAL
PHARMACEUTICALS, INC., a California corporation ("SIGNAL"), having a place of
business at 0000 Xxxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000, and ROCHE
BIOSCIENCE, a Division of Syntex (U.S.A.) Inc., a Delaware corporation ("ROCHE
BIOSCIENCE"), having a place of business at 0000 Xxxxxxxx Xxxxxx, Xxxx Xxxx,
Xxxxxxxxxx 00000.
W I T N E S S E T H:
WHEREAS, SIGNAL has rights to certain technology for the generation of
neuronal and glial cell lines and central nervous system ("CNS") cell lines
generated using the technology;
WHEREAS, SIGNAL and ROCHE BIOSCIENCE desire to conduct a joint research
program to develop [***] and
WHEREAS, ROCHE BIOSCIENCE wishes to evaluate the CNS cell lines
containing certain molecular targets;
NOW, THEREFORE, in consideration of the foregoing premises, and the
mutual covenants set forth below, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of the Agreement, the terms defined in this Article 1 shall
have the respective meanings set forth below:
1.1 "Affiliate" shall mean, with respect to any Person, any other Person
which directly or indirectly controls, is controlled by, or is under common
control with, such Person. A Person shall be regarded as in control of another
Person if it owns, or directly or indirectly controls, more than fifty percent
(50%) of the voting stock or other ownership interest of the other Person, or if
it directly or indirectly possesses the power to direct or cause the direction
of the management and policies of the other Person by any means whatsoever.
Notwithstanding the above, Genentech, Inc., shall not be deemed an Affiliate of
ROCHE BIOSCIENCE for purposes of the Agreement.
1.2 "Cell Type Characterization" will be determined by examining the
[***] A cell shall
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be deemed [***]
1.3 "Cloned Immortalized PNS Cell Lines" shall refer to [***]
1.4 "CNS Cell Lines" shall mean the human central nervous system cell
lines which are part of the SIGNAL Patent Rights.
1.5 "Compound" shall mean a therapeutic agent that is a ligand, agonist
or antagonist to a Signal PNS Cell Line target and has been identified in a
screening assay or ROCHE BIOSCIENCE Assay against a target available due to a
Signal PNS Cell Line, and such ligand, agonist or antagonist activity is the
primary mechanism of action of such therapeutic agent.
1.6 "Extant Genes" shall mean Genes where the rights to the cloned Gene
are not in the public domain or with ROCHE; and where access to SIGNAL cell
lines provides ROCHE BIOSCIENCE with rights to, and a source of, the human form
of the Gene.
1.7 "Field" shall mean therapeutic or diagnostic products directed [***]
1.8 "Gene" shall mean either a gene or a gene product.
1.9 "Immortalized PNS Cells" refers to [***]
1.10 "Invention" shall have the meaning set forth in Section 8.1.
1.11 "Novel Genes" shall mean Genes that are discovered using PNS Cell
Lines which Genes are not related to Extant Genes and have a clear patent
priority filing date.
1.12 "Perpetualized PNS Cells" refers to [***]
1.13 "Person" shall mean an individual, corporation, partnership,
limited liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.
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1.14 "PNS Cell Lines" shall mean the Stable Cell Lines developed
pursuant to the Research Program.
1.15 "Product" shall mean (a) a product for use in the Field which (i)
incorporates a Compound and could not have been developed, manufactured, used,
or sold without infringing one or more claims under the SIGNAL Patent Rights or
(ii) uses or incorporates some portion of one or more PNS Cell Lines; or (b) the
same product defined above for a secondary indication which is for use outside
the Field.
1.16 "Program Support" shall mean the money paid by ROCHE BIOSCIENCE to
SIGNAL to support the Research Program.
1.17 "Public Genes" shall mean human Genes that are in the public domain
and available for research and drug discovery use; or, human Genes that ROCHE
BIOSCIENCE has patented and which are not Novel Genes or Extant Genes.
1.18 "Research Program" shall mean the research study described in the
Research Proposal dated July 10, 1996 attached as Exhibit A to the Agreement.
1.19 "Research Committee" shall mean the joint research committee
comprising representatives of SIGNAL and ROCHE BIOSCIENCE as described in
Paragraph 3.6.1 below.
1.20 "Research Program Period" shall mean the period commencing on the
first day of the month following the Effective Date of the Agreement and
expiring three (3) years from the date thereof, unless the Program Support is
earlier terminated as provided herein.
1.21 "Research Results" shall mean all data and information (but not
Inventions) arising from the research conducted during the Research Program
Period.
1.22 "ROCHE BIOSCIENCE Assays" shall mean any assay utilized by ROCHE
BIOSCIENCE for use in the Field and those other assays to be described in
Exhibit D hereto, as the same may be amended from time to time by the mutual
written agreement of the parties, for use outside the Field.
1.23 "ROCHE BIOSCIENCE Know-How" shall mean all information and data,
which is owned by or licensed to ROCHE BIOSCIENCE (other than through a license
from SIGNAL under this Agreement) during the Research Program Period, is not
generally known (including, but not limited to, formulae, procedures, protocols,
techniques and results of experimentation and testing), and is necessary or
useful to conduct the Research Program or to develop, make, use, sell or seek
regulatory approval in any country to market a Product; all to the extent and
only to the extent that ROCHE BIOSCIENCE now has or hereafter will have the
right to grant licenses, immunities or other rights thereunder.
1.24 "ROCHE BIOSCIENCE Patent Rights" shall mean (a) all patent
applications heretofore or hereafter filed or having legal force in any country
owned by or licensed to
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ROCHE BIOSCIENCE or to which ROCHE BIOSCIENCE otherwise acquires rights (other
than through this Agreement), which claim the ROCHE BIOSCIENCE Assays together
with any and all patents that have issued or in the future issue therefrom,
including utility, model and design patents and certificates of invention, and
(b) all divisionals, continuations, continuations-in-part, reissues, renewals,
extensions or additions to any such patents and patent applications; all to the
extent and only to the extent that ROCHE BIOSCIENCE now has or hereafter will
have the right to grant licenses, immunities or other rights thereunder.
1.25 "ROCHE BIOSCIENCE Technology" shall mean, collectively, the ROCHE
BIOSCIENCE Know-How and the ROCHE BIOSCIENCE Patent Rights.
1.26 "SIGNAL Know-How" shall mean all information and data, which is
owned by or licensed to SIGNAL (other than through a license from ROCHE
BIOSCIENCE under this Agreement) during the Research Program Period, is not
generally known (including, but not limited to, formulae, procedures, protocols,
techniques and results of experimentation and testing), and is necessary or
useful to conduct the Research Program or to develop, make, use, sell or seek
regulatory approval in any country to market a Product arising from the Research
Program for use in the Field; all to the extent and only to the extent that
SIGNAL now has or hereafter will have the right to grant licenses, immunities or
other rights thereunder.
1.27 "SIGNAL Materials" shall mean the PNS Cell Lines and CNS Cell Lines
in which ROCHE BIOSCIENCE is being granted rights under this Agreement.
1.28 "SIGNAL Patent Rights" shall mean (a) all patent applications
heretofore or hereafter filed or having legal force in any country owned by or
licensed to SIGNAL or to which SIGNAL otherwise acquires rights (other than
through this Agreement), which claim (i) the technology for the generation of
neuronal and glial cell lines useful for the development of Compounds or
Products; (ii) the CNS Cell Lines or any cells comprising the foregoing; (iii)
the use of the technology described in clause (i) or the use of the CNS Cell
Lines and cells described in clause (ii) above, together with any and all
patents that have issued or in the future issue therefrom, including utility,
model and design patents and certificates of invention, and (b) all divisionals,
continuations, continuations-in-part, reissues, renewals, extensions or
additions to any such patents and patent applications; all to the extent and
only to the extent that SIGNAL now has or hereafter will have the right to grant
licenses, immunities or other rights thereunder.
1.29 "SIGNAL Technology" shall mean, collectively, the SIGNAL Know-How
and the SIGNAL Patent Rights.
1.30 "Stable Cell Line" shall mean a Cloned Immortalized PNS Cell Line
in which (a) [***]
1.31 "Third Party" shall mean any Person other than SIGNAL, ROCHE
BIOSCIENCE and their respective Affiliates.
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ARTICLE 2
REPRESENTATIONS AND WARRANTIES
Each party hereby represents and warrants to the other party, as of the
date of the Agreement, as follows:
2.1 Existence and Power. Such party (a) is duly organized, validly
existing and in good standing under the laws of the state in which it is
organized; (b) has the requisite power and authority and the legal right to own
and operate its property and assets, to lease the property and assets it
operates under lease, and to carry on its business as it is now being conducted,
and (c) is in compliance with all requirements of applicable law, except to the
extent that any noncompliance would not materially adversely affect such party's
ability to perform its obligations under the Agreement.
2.2 Authorization and Enforcement of Obligations. Such party (a) has the
requisite power and authority and the legal right to enter into the Agreement
and to perform its obligations hereunder, and (b) has taken all necessary action
on its part to authorize the execution and delivery of the Agreement and the
performance of its obligations hereunder. The Agreement has been duly executed
and delivered on behalf of such party, and constitutes a legal, valid, binding
obligation, enforceable against such party in accordance with its terms.
2.3 Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other Persons required to be obtained by such
party in connection with the Agreement have been obtained.
2.4 No Conflict. The execution and delivery of the Agreement and the
performance of such party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations, and (b) do not
conflict with, or constitute a default under, any contractual obligation of such
party.
2.5 DISCLAIMER OF WARRANTIES.
2.5.1 NOTHING IN THE AGREEMENT SHALL BE CONSTRUED AS A
REPRESENTATION MADE, OR WARRANTY GIVEN, BY EITHER PARTY THAT ANY PATENT WILL
ISSUE BASED UPON ANY PENDING PATENT APPLICATION WITHIN THE SIGNAL PATENT RIGHTS
OR THE ROCHE BIOSCIENCE PATENT RIGHTS, THAT ANY PATENT WITHIN THE SIGNAL PATENT
RIGHTS OR THE ROCHE BIOSCIENCE PATENT RIGHTS WHICH ISSUES WILL BE VALID, OR THAT
THE USE OF ANY SIGNAL MATERIALS OR ANY SIGNAL TECHNOLOGY OR THE ROCHE BIOSCIENCE
TECHNOLOGY WILL NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY OTHER
PERSON.
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2.5.2 THE SIGNAL MATERIALS ARE PROVIDED BY SIGNAL "AS IS" AND
WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES OR
WARRANTIES ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES. IN NO
EVENT WILL SIGNAL OR ANY OF ITS THIRD PARTY LICENSORS WHOSE TECHNOLOGY IS
UTILIZED IN PROVIDING SIGNAL MATERIALS HEREUNDER BE LIABLE FOR ANY INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THE LICENSE RIGHTS
BY ROCHE BIOSCIENCE HEREUNDER OR USE OF THE SIGNAL MATERIALS OR THE PRODUCTS.
ARTICLE 3
COLLABORATIVE RESEARCH PROGRAM
3.1 Purpose and Scope. During the Research Program Period, the parties
shall conduct research, as set forth herein, and shall use commercially
reasonable efforts to perform the activities described in Exhibit A and to
efficiently achieve the specific aims thereof, consistent with prudent drug
discovery and development practices. The overall objective is to develop PNS
Cell Lines which may be useful for the discovery of Compounds and the
development of Products. It is expected that SIGNAL shall deliver to ROCHE
BIOSCIENCE within [***] of the end of the Research Program at least
[***] human PNS Cell Lines; however, this expectation shall not be deemed a
representation or warranty by SIGNAL. Provided the Research Program Period is
not terminated early under provisions of the Agreement prior to the intended
full three (3) year term, SIGNAL shall deliver to ROCHE BIOSCIENCE any human PNS
Cell Lines which lines were in the characterization or application stage at the
end of the Research Program Period and the development thereof was completed
within six (6) months after the end of the Research Program Period.
3.2 Allocation of Research Program Efforts. Exhibit A outlines the
duties of each party with respect to the Research Program. In the event that the
acquisition of rights to a Third Party's Intellectual Property are deemed
necessary by the parties in order to complete the Research Program and prevent
possible infringement of that Third Party's rights, ROCHE BIOSCIENCE agrees that
SIGNAL shall not be obligated at SIGNAL's expense to acquire those rights;
however, the parties shall negotiate with each other in good faith to reach a
reasonable commercial solution with respect to avoiding or solving such possible
infringement of a Third Party's rights, including potential negotiation of a
license with that Third Party. Except for the Program Support and as otherwise
provided herein, each party shall be responsible for its own expenses in
performing its duties under the Agreement.
3.3 Research Funding for PNS Cell Line. Unless otherwise agreed to in
writing by the parties, ROCHE BIOSCIENCE shall be responsible for funding the
Research Program activities at SIGNAL by providing payment to support the number
of full-time equivalents
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("FTEs") per Agreement quarter as set forth below, and SIGNAL shall allocate the
specified number of FTE's to the Research Program:
CHART 1
[***]
At any time during [***] of the Agreement, ROCHE BIOSCIENCE has the sole option
to increase the number of FTE's for Program Support during the [***] or [***] up
to a maximum of [***]. ROCHE BIOSCIENCE must make a written request to SIGNAL
for increases within that limit at least ninety (90) days in advance of the
desired addition(s) and SIGNAL shall use commercially reasonable efforts to add
such personnel. The parties by mutual agreement may increase the number of FTE's
beyond [***].
Subject to the other provisions of the Agreement, ROCHE BIOSCIENCE Program
Support costs per FTE shall be as set forth below:
CHART 2
[***]
*The expense per FTE in Chart 2 shall be increased annually, effective as of
each anniversary date of the Research Program Period, commencing with the first
anniversary date, based on increases in the United States Consumer Price Index
for all Urban Consumers ("CPI"), all items not seasonally adjusted (sources
Bureau of Labor Statistics) for the most recent twelve (12) months CPI data
available fifteen (15) days prior to each anniversary date. Once established for
an Agreement year, support costs per FTE shall remain constant throughout that
Agreement year.
Payment of the Program Support costs per FTE shall be made in quarterly
installments in advance commencing on the first day of the Research Program
Period and thereafter by no later than the first day of each successive quarter
of the Research Program (not calendar quarter), with the actual payment required
to be determined by multiplying the number of FTEs to be utilized for that next
quarter (per Chart 1 above or as otherwise modified as provided above) by
twenty-five percent (25%) of the expense per FTE for the year in which that next
quarter occurs (per Chart 2 above).
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3.3.1 Right to Terminate Program Support ROCHE BIOSCIENCE shall
have the right to cease providing Program Support upon the occurrence of certain
events described below and subject to the following terms and conditions:
(a) If Signal fails to [***] by the end of Year One of the
Agreement, then ROCHE BIOSCIENCE, as its sole remedy, has the option to notify
SIGNAL that ROCHE BIOSCIENCE shall cease providing Program Support; provided
such notice is delivered to SIGNAL by no later than ten (10) days after the end
of Year One. In the event ROCHE BIOSCIENCE exercises such option, ROCHE
BIOSCIENCE must continue to provide Program Support for the first quarter of
Year 2 by paying an amount determined by multiplying the number of FTEs being
utilized for the fourth quarter of Year 1 (per Chart 1 in Section 3.3) by
twenty-five percent (25%) of the expense per FTE in Year 2 (per Chart 2 in
Section 3.3), and the obligation to continue Program Support shall terminate
thereafter.
(b) During Year 2 of the Agreement, if SIGNAL fails to
meet certain criteria level standards as set forth in Exhibit B to the
Agreement, ROCHE BIOSCIENCE, as its sole remedy, has an option to notify SIGNAL
that ROCHE BIOSCIENCE shall cease providing Program Support. In the event ROCHE
BIOSCIENCE exercises such option, ROCHE BIOSCIENCE must continue to provide
Program Support for the longer of (i) ninety (90) days after receipt of the
notice by SIGNAL or (ii) the date of intended termination specified in the
notice ("Continuation Period"). During the Continuation Period, ROCHE BIOSCIENCE
must continue to provide Program Support by meeting normally scheduled payment
date(s) in amount(s) determined by multiplying the number of FTEs scheduled to
be assigned to the Research Program during each full or partial quarter of the
Continuation Period (per Chart 1 or as modified per Section 3.3 above ) by the
pro rata expense in Year Two for one FTE during that full or partial quarter of
the Continuation Period (per Chart 2 in Section 3.3 above).
(c) Even if SIGNAL is meeting the criteria level standards
for Year 2 set forth in Exhibit B, ROCHE BIOSCIENCE has an option to notify
SIGNAL that ROCHE BIOSCIENCE shall cease providing Program Support for Year 3;
provided such notice is delivered to SIGNAL by no later than the end of Year 2.
If such notice is not received by SIGNAL prior to the end of the third quarter
of Year 2, then that notice will not be effective until ninety (90) days after
receipt and ROCHE BIOSCIENCE shall be responsible to continue to provide
normally scheduled payments for Program Support until the effective date of the
notice at a rate determined using the method provided in subparagraph (b) above.
If the option under this subparagraph (c) is not exercised prior to the end of
Year 2, then the option shall lapse.
(d) If ROCHE BIOSCIENCE exercises any of the options under
subparagraphs (a), (b) or (c) above, SIGNAL shall work with ROCHE BIOSCIENCE to
wind-down and transition the Research Program in a reasonable commercial manner
during the period between receipt of the notice and the actual expiration of
Program Support as provided in those subparagraphs.
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(e) If ROCHE BIOSCIENCE discontinues the Program Support,
the Research Program Period shall terminate.
3.3.2 No Refund. All Program Support payments shall be
non-refundable, and are not an advance against any license or milestone fees due
under the Agreement.
3.4 Research Results.
3.4.1 Ownership and Use. SIGNAL and ROCHE BIOSCIENCE shall
jointly own the Research Results specifically related to the purpose and scope
of the Research Program (the "Joint Research Results"). Signal shall own the
Research Results that are not specifically related to the purpose and scope of
the Research Program (the "SIGNAL Research Results"). All patent or other
intellectual property rights arising from the conduct of the Research Program
shall be determined as provided in Section 8.1 below. Except as otherwise
provided in Article 4, neither SIGNAL nor ROCHE BIOSCIENCE shall have the right
to use the Joint Research Results, without the prior written consent of the
other party, for any purpose other than (a) to fulfill its respective
obligations under this Agreement and (b) for ROCHE BIOSCIENCE to develop and
commercialize Compounds into human drug Products. SIGNAL shall have the
exclusive rights to (c) use the SIGNAL Research Results outside the Field and
(d) except as provided in Paragraph 4.3.2, use the Joint Research Results to the
extent that such Joint Research Results may have utility outside the Field for
both internal research and research sponsored by a Third Party as part of a
research and development partnership, provided in the latter instance that under
the terms of such partnership at least two of the following criteria are
satisfied: [***] Without any further action by the parties, ROCHE BIOSCIENCE
hereby assigns to SIGNAL any and all intellectual property rights relating to
the SIGNAL Research Results and such rights in the Joint Research Results
involving data and information outside the Field as are appropriate and
necessary to accomplish the purposes of the preceding sentence.
3.4.2 Reports. At least once each ninety (90) days, SIGNAL shall
prepare and provide ROCHE BIOSCIENCE and each member of the Research Committee
with a written research report, in reasonably specific detail, summarizing the
Research Results from its conduct of the Research Program.
3.5 Restrictions on Use of SIGNAL Materials.
3.5.1 Test and Evaluate. ROCHE BIOSCIENCE shall have the right to
use the SIGNAL Materials to develop ROCHE BIOSCIENCE Assays for identifying or
characterizing potential Compounds and developing Products, on the terms and
subject to the conditions of the Agreement. Except as the parties otherwise
expressly agree in writing, ROCHE BIOSCIENCE
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shall not, directly or indirectly, use the SIGNAL Materials for any purpose
other than as set forth in this Paragraph 3.5.1.
3.5.2 Acknowledgment of SIGNAL Ownership. ROCHE BIOSCIENCE
acknowledges that the SIGNAL Materials, together with all SIGNAL Technology
rights relative thereto, are, and shall remain, the sole property of SIGNAL.
Nothing herein shall be deemed to grant to ROCHE BIOSCIENCE rights in the SIGNAL
Materials or the SIGNAL Technology, except as expressly set forth in the
Agreement. ROCHE BIOSCIENCE shall not, directly or indirectly, transfer the
SIGNAL Materials to any Person other than to employees of ROCHE BIOSCIENCE or
its Affiliates. If, at any time, ROCHE BIOSCIENCE ceases to pay the annual
license maintenance fees required under Section 4.2 of the Agreement (except
where excused under the Paragraphs 4.2.1 and 4.2.2), then ROCHE BIOSCIENCE shall
immediately cease use of the SIGNAL Materials for which the annual license
maintenance fees are no longer being paid. Additionally, if the Research Program
is terminated other than by expiration of the full three (3) year Research
Program Period, then ROCHE BIOSCIENCE shall immediately also cease use of the
SIGNAL Materials except those Materials for which the annual license maintenance
fees are continuing either to be paid or the annual license maintenance fees are
excused under Paragraph 4.2.1; or immediately when either of the above
exceptions is no longer satisfied.
3.5.3 Research Purposes. ROCHE BIOSCIENCE UNDERSTANDS THAT THE
SIGNAL MATERIALS ARE EXPERIMENTAL IN NATURE, ARE FOR RESEARCH USE ONLY AND HAVE
NOT BEEN APPROVED FOR HUMAN USE. ROCHE BIOSCIENCE SHALL NOT ADMINISTER THE
SIGNAL MATERIALS TO HUMANS IN ANY MANNER OR FORM.
3.6 Research Committee.
3.6.1 Composition. The Research Program shall be conducted under
the direction of the Research Committee comprising two (2) named representatives
of SIGNAL and two (2) named representatives of ROCHE BIOSCIENCE. Each party
shall appoint its representatives to the Research Committee from time to time,
and may substitute one or more of its representatives, in its sole discretion,
effective upon notice to the other party of such change.
3.6.2 Meetings. The Research Committee shall meet prior to
commencing the activity under the Research Program and shall meet at least once
every four (4) months, either in person or by telephone conference, on such
dates and at such times and places as agreed to by SIGNAL and ROCHE BIOSCIENCE,
with in person meetings alternating between San Diego, California and Palo Alto,
California or such other locations as the parties mutually agree. At such
meetings, the Research Committee shall (a) set and reevaluate goals; (b)
allocate manpower; (c) evaluate the Research Results and (d) modify approaches
to obtain Research Program goals as dictated by the science.
3.6.3 Actions. Any approval, determination or other action agreed
to by all of the members of the Research Committee present at the relevant
Research Committee meeting
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shall be the approval, determination or other action of the Research Committee;
provided, however, that at least one (1) representative of each party are
present at such meeting. Notwithstanding the above, ROCHE BIOSCIENCE shall have
the controlling vote with respect to [***]
3.6.4 Disagreements. All disagreements within the Research
Committee, other than those over which ROCHE BIOSCIENCE has the controlling vote
as provided in Paragraph 3.6.3 above, shall be resolved in the following manner:
(a) The representatives of the Research Committee promptly
shall present the disagreement to the chief executive officer, or another person
designated by the respective chief executive officers, of each of SIGNAL and
ROCHE BIOSCIENCE who has the principal responsibility for such party's work
under the Agreement.
(b) Such executives shall meet to discuss each party's
view and to explain the basis for their respective positions of such
disagreement, and in good faith shall attempt to resolve such disagreement among
themselves.
(c) If such executives cannot promptly resolve such
disagreement, then such executives shall endeavor in good faith to establish a
mutually-acceptable method to resolve such disagreement, and such disagreement
shall be resolved in accordance with such method if so established, or by any
other lawful means if no such method is so established.
3.6.5 Reports. Within ten (10) days following each Research
Committee meeting the Research Committee shall prepare and provide to each party
a reasonably detailed written summary report which shall (a) summarize all
matters discussed by the Research Committee, (b) state any determinations of the
Research Committee and (c) summarize the reasons for each determination
described in clause (b) above.
3.6.6 Disbandonment. Upon conclusion of the Research Program
Period and delivery of the final report under Paragraph 3.6.5, the Research
Committee shall be disbanded.
ARTICLE 4
GRANT OF LICENSES
4.1 PNS Cell Lines.
4.1.1 SIGNAL Grant. SIGNAL, on the terms and subject to the
conditions of the Agreement, hereby grants to ROCHE BIOSCIENCE:
(a) a nonexclusive (except as set forth is Section 4.3),
worldwide, royalty-free license under the SIGNAL Technology, during the Research
Program Period, with
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respect to use of the PNS Cell Lines and to use any one or more of Genes which
are within the PNS Cell Lines to identify Compounds for use in the Field.
(b) a nonexclusive (except as set forth is Section 4.3),
worldwide, royalty-free license under the SIGNAL Technology, after conclusion of
the Research Program Period, with respect to use of the PNS Cell Lines and to
use any one or more of Genes which are within the PNS Cell Lines to develop
Compounds.
(c) a nonexclusive (except as set forth is Section 4.3),
worldwide, royalty-free license under the SIGNAL Technology, after conclusion of
the Research Program Period, to develop, make, use and sell Products.
4.1.2 ROCHE BIOSCIENCE Grant. On the terms and subject to the
conditions of the Agreement, ROCHE BIOSCIENCE hereby grants to SIGNAL a
nonexclusive, worldwide, royalty-free license to use of the ROCHE BIOSCIENCE
Technology, during the Research Program Period.
4.1.3 No Sublicense. Neither SIGNAL under Paragraph 4.1.2 nor
ROCHE BIOSCIENCE under Paragraph 4.1.1, subparagraphs (a) and (b), shall have
the right to grant sublicenses under the licenses granted to any Affiliate or
Third Party. Subject to including applicable provisions of this Agreement in a
sublicense, ROCHE BIOSCIENCE may sublicense under Paragraph 4.1.1, subparagraph
(c), to any Affiliate or Third Party; however, this limited right to sublicense
is not intended to override the proscriptions against sublicensing under the
preceding sentence.
4.2 PNS Annual License Maintenance Fee. Subject to the limitations set
forth in Paragraphs 4.2.1 and 4.2.2 below, ROCHE BIOSCIENCE will be required to
pay to SIGNAL an annual license maintenance fee of [***] for each PNS Cell Line
delivered by SIGNAL to ROCHE BIOSCIENCE pursuant to the Research Program as long
as that PNS Cell Line is continuing to be utilized by ROCHE BIOSCIENCE for drug
research and development purposes. Unless payment of the annual license
maintenance fee is exempted under Paragraphs 4.2.1 or 4.2.2 below, with respect
to a specific PNS Cell Line, such fee will be due and payable within thirty (30)
days after completion and delivery of that PNS Cell Line to ROCHE BIOSCIENCE and
on each anniversary date of the first payment due date thereafter. If payment of
the annual license maintenance fee is exempted at the time of delivery of a PNS
Cell Line, then the first payment with respect thereto shall be due and payable
at the earlier of (a) one year after completion of the full three-year Research
Program Period or (b) thirty (30) days after (i) ROCHE BIOSCIENCE no longer
qualifies for an exemption under Paragraphs 4.2.1 or 4.2.2 below or (ii) early
termination of the Research Program Period.
4.2.1 Maximum License Maintenance Fees. The maximum annual
license maintenance fee required to be paid in any one calendar year with
respect to the PNS Cell Lines is [***] and the maximum of all annual license
maintenance fees payments required with respect to the PNS Cell Lines is [***]
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4.2.2 Waiver of Annual License Maintenance Fees. For any Research
Program year (not calendar year) during the Research Program in which Program
Support provided by ROCHE BIOSCIENCE equals or exceeds [***], then ROCHE
BIOSCIENCE shall not be required to make the annual license maintenance fees
with respect to any PNS Cell Line that would otherwise be required under Section
4.2 above.
4.3 Exclusivity.
4.3.1 Cloned Immortalized PNS Cell Lines. ROCHE BIOSCIENCE'S
license shall be exclusive with respect to a Cloned Immortalized PNS Cell Line
in the Field for as long as ROCHE BIOSCIENCE is either: (a) making annual
license maintenance fee payments with respect thereto, (b) is exempt from making
the payment specified in clause (a) above because of Paragraph 4.2.1 above or
(c) is exempt from making the payment specified in clause (a) above because of
Paragraph 4.2.2 above; provided, that ROCHE BIOSCIENCE is diligently developing
at least one (1) potentially milestone-generating Compound in the Field. The
diligence requirement shall be deemed satisfied initially if ROCHE BIOSCIENCE
files within three (3) years after termination of the Research Program at least
one Investigational New Drug application with the United States Food and Drug
Administration, or an equivalent application with a foreign regulatory
authority, with respect to a Product. Thereafter, ROCHE BIOSCIENCE must be
continuing with human clinical development with respect to that Product or at
all times have at least one other Product undergoing human clinical development
in order to continue to satisfy the diligence requirement.
4.3.2 Novel Genes. For each Novel Gene that is a target in the
Field and is discovered pursuant to the Research Program, after such discovery,
ROCHE BIOSCIENCE'S license shall be exclusive and SIGNAL shall not grant
thereafter a license to any Third Party with respect to that Novel Gene in any
PNS Cell Line in any field of use for as long as ROCHE BIOSCIENCE is making all
milestone payments required under this Agreement with respect to that Novel
Gene. Both parties agree that the ROCHE BIOSCIENCE exclusivity in all fields of
use applies only to the Novel Gene and not to the entire PNS Cell Line, where
exclusivity is controlled by Paragraph 4.3.1.
4.4 Reservation of Rights. Except as otherwise provided herein, SIGNAL
expressly reserves the right for itself, and the right to grant to Affiliates
and Third Parties the right, to use the SIGNAL Technology and SIGNAL Materials
for: (a) research, screening, testing and evaluation purposes inside or outside
the Field, and (b) making, using or selling products or other commercial
services outside the Field.
4.5 Right of First Negotiation. Without limiting the rights implicitly
granted to ROCHE BIOSCIENCE in the definition of Product, ROCHE BIOSCIENCE shall
have the right of first negotiation for a license from SIGNAL for SIGNAL
Research Results and Inventions (if such rights are not included in the the
definiton of Product) for use outside the Field, including without limitation,
[***], if SIGNAL is not prevented under any Third Party agreement from entering
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into such negotiations, and is not otherwise obligated to offer such SIGNAL
Research Results and Inventions to a Third Party.
4.6 Lapse of Licenses. If, at any time, ROCHE BIOSCIENCE ceases to pay
the annual license maintenance fees required under Section 4.2 of the Agreement
(except where excused under the Paragraphs 4.2.1 and 4.2.2), then the licenses
granted hereunder with respect to the PNS Cell Line and all Genes and the
contents thereof shall lapse if ROCHE BIOSCIENCE fails to cure such nonpayment
within thirty (30) days after receipt of notice from SIGNAL. Additionally, if
the Agreement is terminated other than by expiration of the full three (3) year
Program Research Period, then the licenses shall lapse with respect to all PNS
Cell Lines and all Genes except for those for which the annual license
maintenance fees are continuing to be paid.
ARTICLE 5
DILIGENCE AND MILESTONE PAYMENTS FOR RESEARCH PROGRAM
5.1 Diligence Bonus. ROCHE BIOSCIENCE shall pay bonuses to SIGNAL if the
following cell line development and characterization goals are achieved within
the time frame indicated:
[***]
* The right to each successive bonus is not dependent upon earning the preceding
bonus.
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5.2 Target and Drug Discovery Milestones. ROCHE BIOSCIENCE shall make,
subject to the limitations set forth in Paragraphs 5.2.1 and 5.2.2 below, the
following milestone payments to SIGNAL in connection with attainment of the
specified milestone objective relative to various Gene types:
[***]
* All preclinical milestones arising from achievement and payment of milestones
set forth in items 1 through 4 and 7 through 10 of the table shall not exceed
[***]. Payment of any milestones achieved under items 5, 6 and 11 of the table
are to be excluded in determining the total payments against the maximum of
[***].
5.3 Form and Manner of Payment of Milestones and Bonuses. All milestone
and bonus payments provided for in Sections 5.1 and 5.2 above shall be made
within thirty (30)
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days after attainment of the bonus or milestone attaining event. All payments
shall be made in United States Dollars, for SIGNAL's account, by wire transfer
to a United States bank designated in writing by SIGNAL.
5.4 Reports. In order for SIGNAL to monitor the diligence and progress
of ROCHE BIOSCIENCE toward the attainment of milestones payable under the
Agreement, once a PNS Cell Line has been delivered to ROCHE BIOSCIENCE, then
each six (6) months thereafter ROCHE BIOSCIENCE shall deliver to SIGNAL a report
in form reasonably satisfactory to SIGNAL concerning the progress of drug
development.
ARTICLE 6
CNS CELL LINES
6.1 Access Fee. On the Effective Date of the Agreement, ROCHE BIOSCIENCE
shall pay to SIGNAL an access fee ("Access Fee") of [***], which amount shall
allow ROCHE BIOSCIENCE the right to evaluate CNS Cell Lines against the [***]
molecular targets identified on Exhibit C hereto for a period of six months from
the first day of the Research Program Period (the "Evaluation Period"). Within
fifteen (15) days after the first day of the Research Program Period, SIGNAL
shall allow ROCHE BIOSCIENCE access to CNS Cell Lines.
6.2 Grant of Evaluation License for CNS Cell Line. Upon receipt of the
Access Fee and without any further action required, SIGNAL grants to ROCHE
BIOSCIENCE a license under the SIGNAL Technology during the Evaluation Period
with respect to the CNS Cell Lines. The license shall be limited to the
evaluation of the molecular targets identified on Exhibit C and shall be
exclusive with respect to those molecular targets.
6.3 Option to License. During the Evaluation Period, ROCHE BIOSCIENCE
shall have an option to obtain the license(s) described in Section 6.4 below.
ROCHE BIOSCIENCE must give notice to SIGNAL of the exercise of this option no
later than the end of the Evaluation Period.
6.4 Grant of License for CNS Cell Line. On the terms and subject to the
conditions of Article 4 of the Agreement, SIGNAL upon exercise of the option in
Section 6.3, without any further action required by SIGNAL, grants to ROCHE
BIOSCIENCE a nonexclusive, worldwide, royalty-free license under the SIGNAL
Technology with respect to use of the CNS Cell Lines and to the use of any one
or more Genes within the cell lines and within the SIGNAL Technology to develop,
make, use and sell a therapeutic product for use against one of the molecular
targets described in Exhibit C only. With respect to each molecular target
described in Exhibit C, the license grant shall be exclusive (but may not be
sublicensed) and shall remain in effect as long as the license and license
maintenance fees described in Section 6.5 below are paid. If ROCHE BIOSCIENCE
either voluntarily terminates its license with respect a CNS Cell Line or fails
to pay the license fees described in Section 6.5, then the license will lapse
with respect to that CNS Cell Line and any products derived therefrom.
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6.5 CNS Cell Line License Fees. Upon exercise of the option described in
Section 6.3 above, ROCHE BIOSCIENCE shall pay to SIGNAL an additional access
license fee in the amount of [***]. In order to maintain any one or more of the
licenses upon which the option was validly exercised, ROCHE BIOSCIENCE must pay
on each anniversary date of the exercise of the option an annual license
maintenance fee of [***] until a total of [***] of annual license maintenance
fees have been paid pursuant to this Section 6.5.
6.6 Form of Payment. All payments made under this Article 6 shall be
made in United States Dollars, for SIGNAL's account, by wire transfer to a
United States bank designated in writing by SIGNAL.
ARTICLE 7
CONFIDENTIALITY
7.1 Confidential Information. Except with respect to publication rights
described in Section 7.4 below, during the term of the Research Program, and for
a period of ten (10) years following the expiration or earlier termination
thereof, each party shall maintain in confidence the Joint Research Results and
all information of the other party disclosed by the other party and identified
as, or acknowledged to be, confidential (collectively, the "Confidential
Information"), and shall not use, disclose or grant the use of the Confidential
Information except on a need-to-know basis to those directors, officers,
employees, employees of Affiliates and consultants, to the extent such
disclosure is reasonably necessary in connection with such party's activities as
expressly authorized by the Agreement. To the extent that disclosure is
authorized by the Agreement, prior to disclosure, each party hereto shall obtain
agreement of any such Person to hold in confidence and not make use of the
Confidential Information for any purpose other than those permitted by the
Agreement.
7.2 Permitted Disclosures. The confidentiality obligations contained in
Section 7.1 above shall not apply to the extent that (a) any receiving party
(the "Recipient") is required to disclose information by law, order or
regulation of a governmental agency or a court of competent jurisdiction,
provided that the Recipient shall not make any such disclosure (other than a
filing of information or materials with the Unites States Securities and
Exchange Commission, a similar filing of information or materials with the
National Association of Security Dealers or state securities regulators or a
filing of information or materials pursuant to the Xxxx-Xxxxx-Xxxxxx Antitrust
Improvements Act of 1976, as amended, and the rules and regulations thereunder,
as amended or an equivalent filing with a foreign applicable authority) without
first notifying the other party and allowing the other party a reasonable
opportunity to seek injunctive relief from (or protective order with respect to)
the obligation to make such disclosure; or (b) the Recipient can demonstrate
that (i) the disclosed information was public knowledge at the time of such
disclosure to the Recipient, or thereafter became public knowledge, other than
as a result of actions of the Recipient in violation hereof; (ii) the disclosed
information was rightfully known by the Recipient (as shown by its written
records) prior to the date of disclosure to the Recipient by the other party
hereunder; (iii) the disclosed
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information was disclosed to the Recipient on an unrestricted basis from a
source unrelated to any party to the Agreement and not under a duty of
confidentiality to the other party; or (iv) the disclosed information was
independently developed by the Recipient or its Affiliates (as shown by written
records) by persons without access to or use of the Confidential Information of
the other party; or (c) disclosure is required to be made to a governmental
regulatory agency as part of such agency's product license approval process.
7.3 Terms of the Agreement. SIGNAL and ROCHE BIOSCIENCE shall not
disclose any terms or conditions of the Agreement to any Third Party without the
prior consent of the other party, except as required by applicable law or to
Persons with whom ROCHE BIOSCIENCE or SIGNAL has entered into or proposes to
enter into a business relationship, provided that such relationship will not
conflict (or is highly unlikely to interfere) with the purpose of the Agreement
and such Persons shall enter into confidentiality agreement with, or otherwise
owe a duty of confidentiality to SIGNAL or ROCHE BIOSCIENCE, as applicable.
Notwithstanding the foregoing, after execution of the Agreement, ROCHE
BIOSCIENCE and SIGNAL shall agree upon the substance of information that can be
used to describe the terms of this transaction, and ROCHE BIOSCIENCE and SIGNAL
may disclose such information, as modified by mutual agreement from time to
time, without the other party's consent.
7.4 Publications. Prior to any public disclosure or submission for
publication by or on behalf of the parties of a manuscript or other document
describing the Joint Research Results, the party desiring to disclose or submit
such a manuscript ("Disclosing Party") shall send a copy of the proposed
manuscript to the other party ("Responding Party"), and shall allow the
Responding Party not less than thirty (30) days from the date of receipt in
which Responding Party may reasonably determine whether the manuscript contains
either subject matter for which patent protection should be sought to protect
the Responding Party's intellectual property rights prior to publication of the
manuscript or contains Confidential Information belonging to the Responding
Party. In either of these events, the Responding Party may by written notice
request a delay in publication for up to an additional sixty (60) days and/or
deletion of the Responding Party's Confidential Information. Upon receipt of
such written notice from the Responding Party, the Disclosing Party shall delay
public disclosure of such information or submission of the manuscript. After
lapse of the delay period, the Disclosing Party shall be free to publish or
disclose such manuscript, except that the Disclosing Party may not disclose any
Confidential Information of the Responding Party in violation of this Article 7
without the prior written consent of the Responding Party.
ARTICLE 8
INVENTIONS AND PATENTS
8.1 Ownership of Inventions. The entire right and title in all
inventions, discoveries and other technology (except the Research Results),
whether or not patentable, and any patent applications or patents based thereon,
conceived or reduced to practice during the Research Program Period in
connection with the Research Program (collectively, the "Inventions") (a) by
employees or others acting solely on behalf of SIGNAL or its Affiliates, or
which constitute SIGNAL Materials, shall be owned solely by SIGNAL (the "SIGNAL
Inventions"), (b) by
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employees or others acting solely on behalf of ROCHE BIOSCIENCE or its
Affiliates shall be owned solely by ROCHE BIOSCIENCE(the "ROCHE BIOSCIENCE
Inventions"), and (c) jointly by employees or others acting on behalf of SIGNAL
and by employees or others acting on behalf of ROCHE BIOSCIENCE or their
respective Affiliates, or which constitute a use of SIGNAL Materials, shall be
owned jointly by SIGNAL and ROCHE BIOSCIENCE (the "Joint Inventions"). Each
party promptly shall disclose to the other party the conception or reduction to
practice of Inventions by employees or others acting on behalf of such party.
SIGNAL and ROCHE BIOSCIENCE each hereby represents that all employees and other
Persons acting on its behalf in performing its obligations under the Agreement
shall be obligated under a binding written agreement to assign to it, or as it
shall direct, all Inventions made or developed by such employees or other
Persons. SIGNAL agrees that ROCHE BIOSCIENCE shall have exclusive rights,
regardless of ownership, to the use of all intellectual property in the PNS Cell
Lines for use in the Field related to Novel Genes discovered through the use of
the PNS Cell Lines. ROCHE BIOSCIENCE agrees that SIGNAL shall have exclusive
rights, regardless of ownership, to the use of all intellectual property,
including all Inventions arising from the Research Program, for use outside the
Field for both internal research and research sponsored by a Third Party as part
of a research and development partnership, which partnership satisfies at least
two of the criteria described in subparagraphs (d)(i) through (v) of Paragraph
3.4.1; provided ROCHE BIOSCIENCE shall have rights to use such intellectual
property to develop and commercialize Compounds into Products. Each party shall
grant to the other party such worldwide, royalty-free licenses to its Inventions
and Know-How as are reasonably necessary or useful to accomplish the purposes of
the prior two sentences.
8.2 Patent Prosecution and Maintenance.
8.2.1 SIGNAL Inventions. SIGNAL shall have the right, in its sole
discretion and at its sole expense, to control the preparation, filing,
prosecution and maintenance of all SIGNAL Patent Rights and all patents and
patent applications which claim the SIGNAL Inventions.
8.2.2 ROCHE BIOSCIENCE Inventions. ROCHE BIOSCIENCE shall have
the right, in its sole discretion and at its sole expense, to control the
preparation, filing, prosecution and maintenance of all patents and patent
applications which claim the ROCHE BIOSCIENCE Inventions.
8.2.3 Patent Prosecution and Maintenance. SIGNAL and ROCHE
BIOSCIENCE shall determine by mutual agreement which party controls the
preparation, filing, prosecution and maintenance of all patents and patent
applications which claim the Joint Inventions; however, [***].
8.2.4 Rights to Review. In the case of each application and
patent described in this Section 8.2 which claims a Joint Invention, the
controlling party shall use its good faith efforts to provide the other party
with an opportunity to review and comment on the text of each patent application
before filing, and shall supply the other party with a copy of such patent
application as filed, together with notice of its filing date and serial number.
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8.2.5 Cooperation. Each party shall cooperate with the other
party, execute all lawful papers and instruments and make all rightful oaths and
declarations as may be necessary in the preparation, prosecution and maintenance
of all applications and patents described in this Section 8.2.
8.3 Enforcement of Patent Rights.
8.3.1 Notification of Infringement. If at any time, either party
hereto shall become aware of any infringement or threatened infringement by a
Third Party of any or all the SIGNAL Patent Right, ROCHE BIOSCIENCE Patent
Rights or the joint patent rights arising from the Joint Inventions to which the
party having the knowledge thereof claims an interest pursuant to the Agreement,
the party having the knowledge thereof shall promptly give notice thereof to the
other party.
8.3.2 Patent Party Rights. The party (the "Patent Party") with
the right to control the maintenance of the patents described in Section 8.2
above shall have the right to determine the appropriate course of action to
enforce such patents or otherwise xxxxx the infringement thereof, to take (or
refrain from taking) appropriate action to enforce such patents, to control any
litigation or other enforcement action and to enter into, or permit, the
settlement of any such litigation or other enforcement action with respect to
such patents, and shall consider, in good faith, the interests of the other
party in so doing.
8.3.3 Other Party Rights. In the case of each patent described in
this Section 8.2 which claims a Joint Invention, if the Patent Party does not,
within one hundred twenty (120) days of receipt of notice from the other party
xxxxx the infringement or file suit to enforce such patent against at least one
infringing party, the other party shall have the right to take whatever action
it deems appropriate to enforce such patent.
8.3.4 Settlement. The party controlling any such enforcement
action shall not settle the action or otherwise consent to an adverse judgment
in such action that diminishes the rights or interests of the non-controlling
party without the prior written consent of the other party. With respect to
suits to enforce SIGNAL Patent Rights and patents which claim SIGNAL Inventions
or ROCHE BIOSCIENCE Inventions, all moneys recovered upon the final judgment or
settlement of any such suit shall be retained by the controlling party. With
respect to suits to enforce patent which claim Joint Inventions, all moneys
recovered upon the final judgment or settlement of any such suit shall first be
applied to the reimbursement of the parties for their out-of-pocket expenses
(including reasonable attorneys' fees) in prosecuting such infringement with the
balance to be shared by the parties as they mutually agree. If the monetary
recovery is less than the out-of-pocket expenses of the parties, reimbursement
shall be on a pro-rata basis.
8.3.5 Cooperation. Notwithstanding the foregoing, SIGNAL and
ROCHE BIOSCIENCE shall fully cooperate with each other in the planning and
execution of any action to enforce the patents described in Section 8.2 which
claim a Joint Invention.
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8.4 No Other Technology Rights. Except as otherwise provided in the
Agreement, under no circumstances shall a party, as a result of the Agreement,
obtain any ownership interest or other right in any technology, know-how,
patents, pending patent applications, products, vaccines, antibodies, cell lines
or cultures, or animals of the other party, including items owned, controlled or
developed by the other, or transferred by the other to such party at any time
pursuant to the Agreement. It is understood and agreed by the parties that the
Agreement does not grant to either party any license or other right in basic
technology of the other party except to the extent necessary to enable the
parties to carry out their part of the Research Program and as otherwise
provided in Article 6 hereto.
ARTICLE 9
TERM AND TERMINATION
9.1 Expiration. Unless terminated earlier pursuant to Paragraph 3.3.1 or
Section 9.2, the term of the Research Program shall expire at the end of the
full three (3) year Research Program Period. Article 6 and any other provisions
relative to the CNS Cell Lines shall not expire as long as ROCHE BIOSCIENCE
maintains at least one license with respect thereto. The remainder of the
Agreement, unless terminated under Section 9.2 shall not expire until the later
of (a) final license and milestone payments due relative to the PNS Cell Lines
have been made or (b) ROCHE BIOSCIENCE has ceased use of all PNS Cell Lines on
which milestone payments and license fees are otherwise due hereunder.
9.2 Termination for Cause. Either party may terminate the Agreement upon
the occurrence of any of the following:
(a) The other party shall (i) seek the liquidation,
reorganization, dissolution, or winding up of itself (other than dissolution or
winding up for the purposes of reconstruction or amalgamation) or the
composition or readjustment of all or substantially all of its debts, (ii) apply
for or consent to the appointment of, or the taking of possession by, a
receiver, custodian, trustee or liquidator of itself or of all or substantially
all of its assets, (iii) make a general assignment for the benefit of its
creditors, (iv) commence a voluntary case under the United States Bankruptcy
Code, (v) file a petition seeking to take advantage of any other law relating to
bankruptcy, insolvency, reorganization, winding-up or composition or
readjustment of debts, or (vi) adopt any resolution of its board of directors or
stockholders; or for the purpose of effecting any of the foregoing; or
(b) A proceeding or case shall be commenced without the
application or consent of the other party and such proceeding or case shall
continue undismissed, or an order, judgment or decree approving or ordering any
of the following shall be entered and continue unstayed in effect, for a period
of ninety (90) days from and after the date service of process is effected upon
the other party, seeking (i) its liquidation, reorganization, dissolution or
winding up, or the composition or readjustment of all or substantially all of
its debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or
the like of itself or of all or
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substantially all of its assets, or (iii) similar relief under any law relating
to bankruptcy, insolvency, reorganization, winding up or composition or
readjustment of debts; or
(c) Except as otherwise provided in Article 11 below, upon or
after the breach of any material provision of the Agreement, if the breaching
party has not cured such breach within ninety (90) days after notice thereof
from the other party, the Agreement shall terminate, at the option of the other
party, after the expiration of such ninety (90) day cure period.
9.3 Effect of Expiration and Termination. The Research Program shall
cease upon early termination of the Agreement. Expiration or earlier termination
of the Agreement shall not relieve the parties of any obligation or rights
accruing prior to such expiration or termination. The provisions of Articles 4,
5, 6, 7, 8, 10 and 14; Section 2.5; and Paragraphs 3.4.1 and 3.5.2 shall survive
the expiration or earlier termination of the Research Program or Agreement.
ARTICLE 10
INDEMNITY
10.1 Direct Indemnity. Each party shall defend, indemnify and hold the
other party, its Affiliates, directors, officers, employees, agents and
stockholders harmless and hereby forever releases and discharges the other
party, its Affiliates, directors, officers, employees, agents and stockholders
from and against all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) that the other party, its Affiliates,
directors, officers, employees, agents and stockholders may suffer or incur as a
result of any claims, demands, actions or other proceedings made or instituted
by a Third Party against any of them arising out of or relating to (a) any
material breach by the indemnifying party of its obligations under the
Agreement, (b) the gross negligence or willful misconduct in connection with the
activities performed by or on behalf of the indemnifying party hereunder; (c)
the testing, manufacture, use, sale, consumption, distribution or advertising of
any of the Compounds or Products by or on behalf of such party or its
Affiliates, licensees or sublicensees, employees, consultants, agents or
subcontractors pursuant to such party's rights under the Agreement; or (d) the
operations or activities of such a Party's Affiliates, licensees or sublicensees
in material contravention of the requirements of the Agreement. A Third Party
licensor of enabling technology is also indemnified under this Article 10 to the
extent such technology is utilized in the performance of the Agreement.
10.2 Procedure. A party (the "Indemnitee") that intends to claim
indemnification under this Article 10 shall promptly notify the other party (the
"Indemnitor") of any claim, demand, action or other proceeding for which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall have
the right to participate in, and, to the extent the Indemnitor so desires,
jointly with any other indemnitor similarly noticed, to assume the defense
thereof with counsel selected by the Indemnitor; provided, however, that the
Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor, if representation of the Indemnitee by
the counsel retained by the Indemnitor
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would be inappropriate due to actual or potential differing interests between
the Indemnitee and any other party represented by such counsel in such
proceedings. The indemnity obligations under this Article 10 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or action if
such settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld or delayed. The failure to deliver notice to
the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve the
Indemnitor of any liability to the Indemnitee under this Article 10, but the
omission to deliver such notice to the Indemnitor shall not relieve it of any
liability that it may have to the Indemnitee otherwise than under this Article
10. The Indemnitor may not settle the action or otherwise consent to an adverse
judgment in such action that diminishes the rights or interests of the
Indemnitee without the express written consent of the Indemnitee. The
Indemnitee, its employees and agents, shall cooperate fully with the Indemnitor
and its legal representatives in the investigation of any action, claim or
liability covered by this indemnification.
10.3 Insurance. ROCHE BIOSCIENCE and SIGNAL each shall maintain, through
self insurance or otherwise, insurance with respect to its Research Program
Period activities contemplated by the Agreement, in such amount as ROCHE
BIOSCIENCE or SIGNAL, respectively, customarily maintains covering its similar
activities. SIGNAL and ROCHE BIOSCIENCE, as applicable, shall maintain such
insurance for so long as each continues to conduct such activities, and
thereafter for so long as SIGNAL and ROCHE BIOSCIENCE, as applicable, each
customarily maintains insurance for itself covering its similar activities.
So long as ROCHE BIOSCIENCE, or its ultimate parent (currently
Roche Holding Ltd.) maintains a financial net worth as determined by
mutually-agreed generally accepted accounting principles of at least one hundred
million dollars ($100,000,000), then subparagraphs (a) through (g) below shall
not be applicable. However, if the financial net worth decreases below such
amount, then notwithstanding the preceding paragraph, effective as of such time
as any Product enters human clinical trials or, if at time thereafter, the
financial net worth drops below such amount, ROCHE BIOSCIENCE with respect to
that Product shall insure its activities under this Agreement and obtain, keep
in force and maintain insurance, including without limitation product liability
insurance, in amounts sufficient to cover its obligations under this Agreement
and consistent with reasonable business practice in the industry. Without
limiting the foregoing, coverage shall in no event be less than the following:
Comprehensive or Commercial Form General Liability Insurance (contractual
liability included) with limits as follows:
(a) Each occurrence $1,000,000
(b) Products/Completed Operations Aggregate $5,000,000
(c) Personal and Advertising Injury $1,000,000
(d) General Aggregate (commercial form only) $5,000,000
It should be expressly understood, however, that the coverages and limits
referred to under the above shall not in any way limit ROCHE BIOSCIENCE'S
liability. Certificates of insurance evidencing compliance with all requirements
shall be requested and shall provide as follows:
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(e). Provide for thirty (30) day advance written notice to
SIGNAL of any modification or termination;
(f) Indicate that SIGNAL and the University of California have
been endorsed as insureds under the coverages referred to under the above; and
(g) Include a provision that the coverages will be primary and
will not participate with nor will be excess over any valid and collectable
insurance or program of self - insurance carried or maintained by ROCHE
BIOSCIENCE.
ARTICLE 11
FORCE MAJEURE
Neither party shall be held liable or responsible to the other party nor be
deemed to have defaulted under or breached the Agreement for failure or delay in
fulfilling or performing any term of the Agreement to the extent, and for so
long as, such failure or delay is caused by or results from causes beyond the
reasonable control of the affected party including but not limited to fire,
floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party.
ARTICLE 12
ASSIGNMENT
The Agreement may not be assigned or otherwise transferred (except to an
Affiliate of a party), nor, except as expressly provided hereunder, may any
right or obligations hereunder be assigned or transferred by either party
without the written consent of the other party; provided, however, that either
SIGNAL or ROCHE BIOSCIENCE may, without such written consent, assign the
Agreement and its rights and obligations hereunder in connection with the
transfer or sale of all or substantially all of its business (or, in the case of
SIGNAL, all or substantially all of the business containing the SIGNAL
Technology to be utilized in performance of the Agreement), or in the event of
its merger or consolidation or change in control or similar transaction.
Anypermitted assignee shall assume all obligations of its assignor under the
Agreement.
ARTICLE 13
SEVERABILITY
Each party hereby acknowledges that it does not intend to violate any public
policy, statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body thereof of any country or community or
association of countries. Should one or more provisions of the Agreement be or
become invalid, the parties shall substitute, by mutual
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consent, valid provisions for such invalid provisions which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that it
can be reasonably assumed that the parties would have entered into the Agreement
with such provisions. In case such provisions cannot be agreed upon, the
invalidity of one or several provisions of the Agreement shall not affect the
validity of the Agreement as a whole, unless the invalid provisions are of such
essential importance to the Agreement that it is to be reasonably assumed that
the parties would not have entered into the Agreement without the invalid
provisions.
ARTICLE 14
MISCELLANEOUS
14.1 Notices. Any consent, notice or report required or permitted to be
given or made under the Agreement by one of the parties to the other shall be in
writing, delivered personally or by facsimile (and promptly confirmed by
personal delivery, US first class mail or courier), US first class mail or
courier, postage prepaid (where applicable), addressed to such other party at
its address indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor and (except as otherwise
provided in the Agreement) shall be effective upon receipt by the addressee.
If to SIGNAL: Signal Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: President
Telefax number: (000) 000-0000
If to ROCHE BIOSCIENCE: ROCHE BIOSCIENCE, a Division of Syntex
(U.S.A.) Inc.
0000 Xxxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Attention: Head, Neurobiology Unit
Telefax number: (000) 000-0000
with a copy to: ROCHE BIOSCIENCE, a Division of Syntex
(U.S.A.) Inc.
0000 Xxxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Attention: Legal Department
Telefax number: (000) 000-0000
14.2 Applicable Law. The Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard to the
conflicts of law principles thereof.
25
26
14.3 Compliance with Applicable Laws. The parties shall use reasonable
efforts to comply with all applicable laws, regulations and governmental orders
in connection with their respective activities related to the Agreement,
including without limitation the research, development, manufacture, use and
sale of Products. Without limiting the foregoing, ROCHE BIOSCIENCE shall observe
all applicable United States and foreign laws with respect to the transfer of
Product and related technical data to foreign countries, including without
limitation, the International Traffic in Arms Regulations (ITAR) and the Export
Administration Regulations.
14.4 Entire Agreement. The Agreement, including the Exhibits hereto,
constitutes the entire understanding of the parties with respect to the subject
matter hereof. All express or implied agreements and understandings, either oral
or written, heretofore made are expressly superseded by the Agreement. The
Agreement may be amended, or any term hereof modified, only by a written
instrument duly executed by both parties.
14.5 Headings. The captions to the several Articles, Sections and
Paragraphs hereof are not a part of the Agreement, but are merely guides or
labels to assist in locating and reading the several Articles, Sections and
Paragraphs hereof.
14.6 Independent Contractors. It is expressly agreed that SIGNAL and
ROCHE BIOSCIENCE shall be independent contractors and that the relationship
between the two parties shall not constitute a partnership, joint venture or
agency. Neither SIGNAL nor ROCHE BIOSCIENCE shall have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which shall be binding on the other, without the prior consent of the party to
do so.
14.7 Waiver. Unless otherwise provided herein, no failure or delay on
the part of a party in exercising any right under the Agreement, irrespective of
the length of time for which such failure or delay shall continue, shall operate
as a waiver of, or impair, any such right. The waiver by either party of any
right hereunder or the failure to perform or of a breach by the other party
shall not be deemed a waiver of any other right hereunder or of any other breach
or failure by said other party whether of a similar nature or otherwise.
14.8 Further Assurances. The parties shall cooperate with each other and
execute and deliver to each other such other instruments and documents and take
such other actions as may be reasonable requested from time to time in order to
carry out, evidence and confirm the rights and intended purposes of the
Agreement.
14.9 Counterparts. The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
26
27
IN WITNESS WHEREOF, the parties have executed the Agreement as of the date first
set forth above.
SIGNAL PHARMACEUTICALS, INC.
By /s/ XXXX X. XXXXX
-----------------------------
Name Xxxx X. Xxxxx
--------------------------
Title President
-------------------------
ROCHE BIOSCIENCE, a Division of Syntex (U.S.A.), Inc.
By /s/ XXXXX X. XXXXX 8/21/96
-----------------------------
Name Xxxxx X. Xxxxx
--------------------------
Title President
--------------------------
27
28
EXHIBIT A
[***]
28
***Confidential Treatment Requested
29
EXHIBIT B
CRITERIA LEVEL STANDARDS
[***]
B-1
***Confidential Treatment Requested
30
EXHIBIT C
MOLECULAR TARGETS OF CNS CELL LINES
[***]
C-1
***Confidential Treatment Requested
31
EXHIBIT D
ROCHE BIOSCIENCE ASSAYS
None on the Effective Date.
D-1
32
CONFIDENTIALITY AGREEMENT
SIGNAL PHARMACEUTICALS, INC.
THIS AGREEMENT, effective December 12, 1996 (the "Effective Date"), by and
between Roche Bioscience, a division of Syntex (U.S.A.) Inc. ("Roche
Bioscience"), having an address at 0000 Xxxxxxxx Xxxxxx, Xxxx Xxxx, Xxxxxxxxxx
00000, and Signal Pharmaceuticals, Inc. ("Signal"), having an address at 0000
Xxxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000, shall govern the conditions of
disclosure by Signal and its affiliates to Roche Bioscience of written
confidential Information dealing with Signal's bone disease programs
("Information"). This Agreement and any other Agreement specifically excludes
Information communicated concerning NF(K)B (ubiquitin).
1. In consideration of Signal's and its affiliates' disclosure to Roche
Bioscience of said Information, Roche Bioscience hereby agrees:
(a) not to use such Information except for the sole purpose of
evaluating its interest therein; and
(b) not to disclose or transfer Information to others (except to its
employees who reasonably require same for the sole purpose hereof
and who are bound to it by like obligations as to
confidentiality) without the express written permission of
Signal, except that Roche Bioscience shall not be prevented from
using or disclosing Information that:
(i) Roche Bioscience can demonstrate by written records was
known to Roche Bioscience before the date of disclosure
hereunder;
(ii) is now, or becomes in the future, publicly available
other than by breach of this Agreement by Roche
Bioscience; or
(iii) is lawfully disclosed to Roche Bioscience on a
non-confidential basis by a third party who is not
obligated to Signal or any other party to retain such
Information in confidence.
2. If samples are provided by Signal or its affiliates to Roche Bioscience
and Roche Bioscience formulates, modifies and/or tests the samples in any way,
Roche Bioscience shall submit all resulting Information and/or test results to
Signal. Roche Bioscience shall treat said Information and/or test results in the
same manner as Information under the terms of Section 1, above, unless the
parties agree otherwise in writing.
3. It is further agreed that the furnishing of Information under this
Agreement shall not constitute any grant, option or license to Roche Bioscience
under any patent or other rights now or hereafter held by Signal or any of its
affiliates with respect to said Information.
1
33
4. The obligations of Roche Bioscience under the terms of this Agreement
shall remain in effect for five (5) years from the date of disclosure.
5. This Agreement shall be interpreted and enforced in accordance with the
law of the State of California (regardless of the choice of law principles of
California or any other jurisdiction).
ROCHE BIOSCIENCE, a division SIGNAL PHARMACEUTICALS, INC.
of Syntex (U.S.A.) Inc.
By X. XXXXX By /s/ XXXX XXXXXXXX
------------------------- ------------------------------
Print Name X. Xxxxx Print Name XXXX XXXXXXXX
------------------------- ------------------------------
Title ILLEGIBLE Title EVP
------------------------- ------------------------------
Date 12 DEC 1996 Date 12/12/96
------------------------- ------------------------------
2
34
[SIGNAL PHARMACEUTICALS, INC. LOGO]
CONFIDENTIALITY OBLIGATIONS
Signal Pharmaceuticals, Inc. [the Company] requests that Agouron
Pharmaceuticals, Inc. (the "Recipient") sign the following confidentiality
agreement in connection with your review of certain proprietary business
information of the Company as described below.
The Recipient acknowledges that the Recipient is receiving confidential
information, financial information, business plans relating to transcriptional
regulation of HPV and its use for the discovery of novel therapeutic agents and
other proprietary information of the Company, which plans contain sensitive
confidential information about the Company that is valuable to them in their
businesses. In addition, the recipient will receive oral information from
officers of the Company regarding its plans, strategies and finances. All such
information shall be deemed "Confidential Information" unless otherwise provided
as below.
The Recipient and the Company agree [a] that the Confidential Information
will be and will remain the sole property of the Company, [b] that all
proprietary rights in connection with the Confidential Information will be and
will remain the sole property of the Company and [c] that nothing in this
Agreement is to be construed as granting or conferring any rights by license or
otherwise, expressly or impliedly, for any business strategy, marketing plan,
invention, discovery, protocol design or improvement on any of the foregoing,
embodied in the Confidential Information disclosed hereunder.
The Recipient agrees to use the Confidential Information solely for the
purpose of evaluating the potential relationship between the Recipient and the
Company.
The Recipient agrees that, for a period of five [5] years from the date
upon which this Agreement is accepted you will maintain all Confidential
Information in confidence and will refrain from using any such Confidential
Information for any purpose, unless so authorized in writing by the Company.
The Company agrees that no obligation of confidentiality or limitation on
use will apply to any information which:
was known by the Recipient prior to receipt hereunder, as evidenced by
written records in your possession; or
was generally known to the public prior to its receipt by the
Recipient hereunder; or
subsequent to receipt hereunder becomes generally known to the public
other than by any act or omission on the Recipient's part; or
35
subsequent to receipt hereunder, is made available to the Recipient by
a third party legally entitled to do so; or
was independently developed by the Recipient without reference to the
information received from the Company hereunder, as evidenced by
written records in your possession; or
is required by law, regulation, rule, act or order of any governmental
authority to be disclosed.
Immediately upon written request of the Company, the Recipient will return
to the Company any and all written or tangible forms of Confidential Information
and all copies thereof, with the exception of one copy to be retained for
reference and proof.
The Company represent and warrants that it owns the Confidential Information and
has the right to disclose the same to the Recipient.
The Recipient agrees that this Agreement supersedes all prior discussions
and writings and constitutes the entire agreement between the Recipient and the
Company with respect to your confidentiality obligations. No waiver or
modification will be binding upon either party unless made in writing and signed
by you as a duly authorized representative of the Company. The failure of the
Company to enforce at any time or for any period of time the provisions of this
Agreement will not be construed to be a waiver of such provisions or of the
rights to enforce each and every such provision.
If the foregoing is acceptable to you, please indicate your concurrence by
signing the duplicate originals of this Agreement.
By: /s/ XXXX X. XXXXXX
-------------------------------------
Xxxx X. Xxxxxx, Ph.D.
Vice President, Corporate Development
Agreed To and Accepted:
/s/ XXXX X. XXXXXXXX
-------------------------------------
Signature
Xxxx X. Xxxxxxxx, Esq. September 5, 1996
------------------------------------- -------------------------
Vice President and General Counsel
Name Date
[SIGNAL PHARMACEUTICALS INC. LOGO]
36
FIRST AMENDMENT TO COLLABORATIVE RESEARCH AGREEMENT
THIS FIRST AMENDMENT TO COLLABORATIVE RESEARCH AGREEMENT is entered into
effective September 5, 1997 by and between Syntex (U.S.A.) Inc., through its
Roche Bioscience division ("Roche Bioscience") and Signal Pharmaceuticals, Inc.
("Signal").
WHEREAS, the parties entered into a Research Collaboration Agreement
dated August 26, 1996 (the "Agreement");
WHEREAS, under Section 3.3.1(a) of the Agreement, Roche Bioscience has the
right to cease providing Program Support if Signal fails to [***]
WHEREAS, Signal recently delivered to Roche Bioscience what Signal believes
is a [***] Roche Bioscience is determining whether what Signal delivered is a
[***]
WHEREAS, Roche Bioscience wishes to have additional time to make such
determination and Signal wishes to grant such extension of time to Roche
Bioscience.
NOW, THEREFORE, in consideration of the mutual promises contained herein
and for other good and valuable consideration receipt of which is hereby
acknowledged, the parties agree as follows:
1. Any defined terms not defined herein shall have the meaning set forth
in the Agreement.
2. Section 3.1.1(a) is hereby amended by deleting "ten (10) days after
the end of Year One" at the end of the first sentence and replacing it with
"September 30, 1997" so that the first sentence of Section 3.1.1(a) reads as
follows:
If Signal fails to [***] by the end of Year One of the Agreement, then
Roche Bioscience, as it sole remedy, has the option to notify Signal that
Roche Bioscience shall cease providing Program Support; provided that such
notice is delivered to Signal by no later than September 30, 1997.
3. All other terms and conditions of the Agreement shall remain the same.
IN WITNESS WHEREOF, the parties have executed this First Amendment to be
effective as of the date first written above.
ROCHE BIOSCIENCE SIGNAL PHARMACEUTICALS, INC.
a division of SYNTEX (U.S.A.) INC.
By /s/ XXXXX X. XXXXX By /s/ XXXX XXXXXXXX
-------------------------------- -------------------------
Xxxxx X. Xxxxx
Vice President, Neurobiology Print Name XXXX XXXXXXXX
Business Unit
Title Executive Vice President
Date 4 September 1997 Date September 8, 1997
***Confidential Treatment Requested
