EXHIBIT 10.30
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF
THIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS
ENCLOSED BY BRACKETS AND UNDERLINED. THE CONFIDENTIAL PORTION HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
COLLABORATIVE RESEARCH, DEVELOPMENT
AND LICENSE AGREEMENT
BETWEEN
EPOCH PHARMACEUTICALS INC.,
AND
SPECIALTY LABORATORIES.
COLLABORATIVE RESEARCH, DEVELOPMENT
AND LICENSE AGREEMENT
THIS COLLABORATIVE RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT (this
"Agreement"), entered into as of May 9, 2000 (the "Effective Date") by and
between EPOCH PHARMACEUTICALS INC., a Delaware corporation (doing business as
Epoch Biosciences) with offices at 00000 000xx Xxxxx X.X. #000, Xxxxxxx,
Xxxxxxxxxx ("Epoch") and SPECIALTY LABORATORIES, a California corporation, with
offices at 0000 Xxxxxxxx Xxxxxx, Xxxxx Xxxxxx, Xxxxxxxxxx ("Specialty
Laboratories").
W I T N E S S E T H:
WHEREAS, Epoch has developed DNA sequence detection systems for use in
specified TaqMan Assays; and
WHEREAS, Specialty Laboratories is engaged in the research, development
and marketing of assays for the detection of human leukemias; and
WHEREAS, Epoch and Specialty Laboratories desire to enter into a
collaborative relationship to conduct research with the goal of developing
improved sequence detection probes for use in specified TaqMan Assays for the
detection of human leukemias.
NOW, THEREFORE, in consideration of the foregoing and the covenants and
premises contained in this Agreement, the parties agree as follows:
1. DEFINITIONS. As used herein, the following terms shall have the
following meanings:
1.1 "PRE-COLLABORATION EPOCH KNOW-HOW" shall mean all
tangible or intangible know-how, trade secrets, inventions (whether or not
patentable), data, preclinical and clinical results, physical, chemical or
biological material, and other information and data on or relating to Epoch
Probes that Epoch owns, controls or to which it has a license with the right to
sublicense on the Effective Date.
1.2 "PRE-COLLABORATION EPOCH PATENTS" shall mean, to the
extent useful in the Field, all foreign and domestic: (a) patents existing as of
the Effective Date or issued during the Research Term; and (b) patents issuing
from patent applications that are pending as of the Effective Date or during the
Research Term (including provisionals, divisionals, continuations and
continuations-in-part of such applications); and (c) substitutions, extensions,
reissues, renewals and inventors certificates relating to the foregoing patents,
which Epoch owns or controls or to which Epoch has a license (with the right to
sublicense). Pre-Collaboration Epoch Patents existing as of the Effective Date
include the patents and applications listed in EXHIBIT B attached hereto.
1.3 "PRE-COLLABORATION EPOCH TECHNOLOGY" shall mean the
Pre-Collaboration Epoch Patents and the Pre-Collaboration Epoch Know-How.
1.4 "COLLABORATION EPOCH KNOW-HOW" shall mean all tangible
or intangible know-how, trade secrets, inventions (whether or not patentable),
data, preclinical and clinical results, physical, chemical or biological
material, and other information and data on or relating to Epoch
2
Probes that is independently developed by Epoch during the Research Term and, in
each case, any replication or any part of such information or material.
1.5 "COLLABORATION EPOCH PATENTS" shall mean any patents
solely owned by Epoch pursuant to Section 9.1.
1.6 "COLLABORATION EPOCH TECHNOLOGY" shall mean the
Collaboration Epoch Patents and the Collaboration Epoch Know-How.
1.7 "EFFECTIVE EPOCH PROBES" shall mean any Epoch Probe that
demonstrates the requisite activity levels in the TaqMan Assays pursuant to the
Research Plan.
1.8 "AFFILIATE" shall mean any company or entity controlled
by, controlling, or under common control with a party hereto and shall include
any company of which greater than fifty percent (50%) of whose voting stock or
participating profit interest is owned or controlled, directly or indirectly, by
a party, and any company which owns or controls, directly or indirectly, greater
than fifty percent (50%) of the voting stock of a party.
1.9 "PRE-COLLABORATION SPECIALTY LABORATORIES KNOW-HOW"
shall mean all tangible or intangible know-how, trade secrets, inventions
(whether or not patentable), data, preclinical and clinical results, physical,
chemical or biological material, and other information and data on or relating
to Epoch Probes that Specialty Laboratories owns, controls or to which it has a
license with the right to sublicense on the Effective Date.
1.10 "PRE-COLLABORATION SPECIALTY LABORATORIES PATENTS" shall
mean, to the extent useful in the Field, all foreign and domestic: (a) patents
existing as of the Effective Date or issued during the Research Term; and (b)
patents issuing from patent applications that are pending as of the Effective
Date or during the Research Term (including provisionals, divisionals,
continuations and continuations-in-part of such applications); and (c)
substitutions, extensions, reissues, renewals and inventors certificates
relating to the foregoing patents, which Specialty Laboratories owns or controls
or to which Specialty Laboratories has a license (with the right to sublicense).
Pre-Collaboration Specialty Laboratories Patents existing as of the Effective
Date include the patents and applications listed in EXHIBIT B attached hereto.
1.11 "PRE-COLLABORATION SPECIALTY LABORATORIES TECHNOLOGY"
shall mean the Pre-Collaboration Specialty Laboratories Patents and the
Pre-Collaboration Specialty Laboratories Know-How.
1.12 "COLLABORATION SPECIALTY LABORATORIES KNOW-HOW" shall
mean all tangible or intangible know-how, trade secrets, inventions whether or
not patentable, data, preclinical and clinical results, physical, chemical or
biological material, and other information and data on or relating to all Epoch
Probes that are independently developed by Specialty Laboratories or its
Affiliates during the Research Term and, in each case, any replication or any
part of such information or material.
1.13 "COLLABORATION SPECIALTY LABORATORIES PATENTS" shall
mean any patents solely owned by Specialty Laboratories pursuant to Section 9.1.
3
1.14 "COLLABORATION SPECIALTY LABORATORIES TECHNOLOGY" shall
mean the Collaboration Specialty Laboratories Patents and the Collaboration
Specialty Laboratories Know-How.
1.15 "COLLABORATION" shall mean the programs of collaborative
research and development under this Agreement for the discovery, selection,
synthesis, investigation, and preclinical and clinical development of Epoch
Probes for use in the Field.
1.16 "JOINT COLLABORATION KNOW-HOW" shall mean any and all
tangible or intangible know-how, trade secrets, inventions (whether or not
patentable), data, preclinical and clinical results, physical, chemical or
biological material, and other information and data that is (a) useful for
purposes of the Collaboration and/or that relates to Epoch Probes or
Collaboration Epoch Probes, and (b) that is derived from or developed pursuant
to activities undertaken by both parties, including their consultants or
collaborators in the conduct of the Collaboration, and, in each case, any
replication or any part of such information or material.
1.17 "COLLABORATION EPOCH PROBE" shall mean an Epoch Probe
selected pursuant to Section 4 hereof for further pre-clinical and clinical
development and commercialization for use in the Field.
1.18 "JOINT COLLABORATION PATENTS" shall mean all foreign and
domestic patents (including substitutions, extensions, reissues, renewals and
inventors certificates relating thereto) that issue from patent applications
including provisionals, divisionals, continuations and continuations-in-part of
such applications that claim inventions in the Joint Collaboration Know-How and
that are filed by or on behalf of one or both of the parties hereto.
1.19 "JOINT COLLABORATION TECHNOLOGY" shall mean the Joint
Collaboration Patents and the Joint Collaboration Know-How.
1.20 "COLLABORATION SPECIALTY LABORATORIES PRODUCT" shall
mean any Specialty Laboratories TaqMan Assay incorporating any (i)
Pre-Collaboration Epoch Technology, (ii) Collaboration Epoch Technology, (iii)
Collaboration Specialty Laboratories Technology exclusively licensed to Epoch
pursuant to Section 6(b)(ii) or (iv) Joint Collaboration Technology, in the
Field by Specialty Laboratories, its Affiliates or its sublicensees; including
all formulations, line extensions and modes of administration thereof.
1.21 "CONFIDENTIAL INFORMATION" shall mean all information,
inventions, know-how or data disclosed by a party to the other pursuant to this
Agreement including, without limitation, manufacturing, marketing, financial,
personnel, scientific and other business information and plans, and the material
terms of this Agreement, whether in oral, written, graphic or electronic form.
1.22 "FIELD" shall mean the detection of human leukemias
utilizing TaqMan Assays, solely at the Specialty Laboratories facility located
at 0000 Xxxxxxxx Xxxxxx, Xxxxx Xxxxxx, XX, provided however, that this Agreement
may be amended to include other fields of study by mutual agreement of the
parties hereto.
4
1.23 "NET SALES" shall mean, the amount invoiced by Specialty
Laboratories, their Affiliates or sub-licensees to Third Parties for the TaqMan
Assay utilizing Collaboration Epoch Probes or for any Collaboration Specialty
Laboratories Product (i) less cash discounts and/or quantity discounts allowed,
(ii) less sales and use taxes, duties or other government tariffs and other
similar taxes incurred and government mandated rebates, (iii) less accruals for
estimated contract rebates, bid rebates, Medicaid rebates and any other similar
rebates as Specialty Laboratories may be required to pay from time to time, and
[***]*. All of the foregoing shall be determined in accordance with standard
accounting methods.
1.24 "REGULATORY APPROVAL" shall mean any and all approvals
(including price and reimbursement approvals), licenses, registrations, or
authorizations of the United States or European Union or any country, federal,
state or local regulatory agency, department, bureau or other government entity
that is necessary for the manufacture, use, storage, import, transport and/or
sale of an Collaboration Specialty Laboratories Product in such jurisdiction.
1.25 "EPOCH PROBES" means locus-specific oligonucleotide
probes incorporating Pre-Collaboration Epoch Technology, Collaboration Epoch
Technology or Joint Collaboration Technology, used to perform the TaqMan Assay.
1.26 "RESEARCH PLAN" shall mean the plan for conducting the
research under the Collaboration, as amended from time to time by the parties.
The initial Research Plan shall be developed and agreed upon by the parties
hereto within ninety (90) days of the Effective Date and attached to this
Agreement as EXHIBIT A. Any amendments or revisions to the Research Plan shall
be in writing and shall require unanimous approval of the parties.
1.27 "RESEARCH PROGRAM" shall mean a collaborative research
program in the Field under this Agreement with the goal of designating
approximately [***]* Effective Epoch Probes as Collaboration Epoch Probes for
development and commercialization in the Field.
1.28 "RESEARCH TERM" shall mean one (1) year following the
Effective Date and one additional one (1) year renewal period upon written
notice from Specialty Laboratories no less than one (1) month prior to the
anniversary of the Effective Date. The Research Term may be further extended
upon terms to be agreed upon by the parties in good faith negotiations.
1.29 "ROYALTY TERM" shall mean, in the case of each
Collaboration Specialty Laboratories Product, the period of time commencing on
the date hereof and ending upon the later of (a) ten (10) years from the date
hereof, or (b) the expiration of the last to expire Valid Claim covering such
Collaboration Specialty Laboratories Product in such country.
1.30 "TaqMan Assays" shall mean the real time nucleic acid
detection method involving polymerase chain reaction technology and 5'
exonuclease activity of Taq polymerase.
1.31 "TERM OF THE AGREEMENT" shall have the meaning ascribed
in Section 12.1.
1.32 "THIRD PARTY" shall mean any entity other than Specialty
Laboratories or Epoch or an Affiliate of Specialty Laboratories or Epoch.
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5
1.33 "VALID CLAIM" shall mean a claim of an unexpired patent
included within the patent rights licensed hereunder, which has not been held
unenforceable, unpatentable or invalid by a decision of a court or other
governmental agency of competent jurisdiction and which has not been admitted to
be invalid or unenforceable through reexamination, reissue or disclaimer or
otherwise.
2. SCOPE OF COLLABORATION; DEVELOPMENT RESPONSIBILITIES;
EXCLUSIVITY AND GOVERNANCE.
2.1 SCOPE OF COLLABORATION. The parties hereby agree to
establish and conduct, during the Research Term, a collaborative research
program in accordance with the Research Plan and the terms of this Agreement.
The initial Research Plan shall be developed and agreed upon by the parties
hereto within ninety (90) days of the Effective Date and attached to this
Agreement as EXHIBIT A. Pursuant to the Collaboration, the parties will
collaborate in developing and identifying Effective Epoch Probes with the goal
of developing approximately [***]* Epoch Probes for [***]* TaqMan Assays for
various human leukemias. The parties agree to cooperate and exchange research
information on a reasonable basis in furtherance of the Research Plan.
2.2 DEVELOPMENT RESPONSIBILITIES. Epoch will be responsible
for providing Epoch Probes to Specialty Laboratories. Specialty Laboratories
will be responsible for the preclinical development of Collaboration Epoch
Probes in the Field.
3. TECHNOLOGY TRANSFER AND IDENTIFICATION OF EFFECTIVE EPOCH
PROBES.
3.1 TRANSFER OF EPOCH TECHNOLOGY. Commencing promptly after
the Effective Date and from time to time thereafter, Epoch will disclose to
Specialty Laboratories all of the Pre- Collaboration Epoch Know-How,
Collaboration Epoch Know-How and Joint Collaboration Know-How as is reasonably
necessary to enable Specialty Laboratories to perform its Collaboration
activities hereunder in accordance with the Research Plan and otherwise to
exercise fully the licenses granted to Specialty Laboratories hereunder. During
the Term of the Agreement, Epoch will provide Specialty Laboratories with
reasonable technical assistance relating to the use of such Pre- Collaboration
Epoch Know-How, Collaboration Epoch Know-How and Joint Collaboration Know-How
and the practice of such Pre-Collaboration Epoch Patents, Collaboration Epoch
Patents and Joint Collaboration Patents in the Field solely to the extent
permitted under the licenses granted to Specialty Laboratories herein. In the
event that Epoch provides any materials to Specialty Laboratories pursuant to
the Research Plan, the parties will enter into a Materials Transfer Agreement in
the form attached hereto as EXHIBIT C with respect to such materials.
3.2 TRANSFER OF COLLABORATION SPECIALTY LABORATORIES
KNOW-HOW. Commencing promptly after the Effective Date and from time to time
thereafter, Specialty Laboratories shall disclose to Epoch all of the Pre-
Collaboration Specialty Laboratories Know-How, Collaboration Specialty
Laboratories Know-How and Joint Collaboration Know-How as is reasonably
necessary to enable Epoch to perform its Collaboration activities hereunder in
accordance with the Research Plan and otherwise to exercise fully the licenses
granted to Epoch hereunder. During the Term of the Agreement, Specialty
Laboratories will provide Epoch with reasonable technical assistance relating to
the use of such Pre- Collaboration Specialty Laboratories Know-How,
Collaboration Specialty Laboratories Know-How and Joint Collaboration Know-How
and the practice of the Pre-Collaboration Specialty Laboratories Patents,
Collaboration Specialty Laboratories Patents and Joint
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6
Collaboration Patents solely to the extent permitted under the licenses
granted to Epoch herein. In the event that Specialty Laboratories provides any
materials to Epoch pursuant to the Research Plan, the parties will enter into a
Materials Transfer Agreement in the form attached hereto as EXHIBIT C with
respect to such materials.
3.3 IDENTIFICATION OF EFFECTIVE EPOCH PROBES. During the
Research Term, the parties shall collaborate in accordance with the Research
Plan to perform research to identify Effective Epoch Probes with the potential
to become Collaboration Epoch Probes.
4. EPOCH PROBE TESTING AND SELECTION. Epoch and Specialty
Laboratories shall jointly select Epoch Probes for use in the Collaboration as
set forth in the Research Plan. The parties shall consult each other from time
to time as reasonably necessary to provide progress reports as to the
Collaboration and the status of the Research Plan.
5. PRODUCT DEVELOPMENT MANUFACTURING AND SUPPLY. Epoch shall be
responsible for providing, at Specialty Laboratories' expense, the supply of all
Epoch Probes in connection with the Research Plan.
6. LICENSE GRANTS.
6.1 LICENSE GRANTS FOR COLLABORATIVE RESEARCH.
(a) GRANT BY EPOCH.
(i) Solely during the Research Term, with
respect to Collaboration Epoch Probes, Epoch grants to Specialty Laboratories a
non-exclusive license in the Pre-Collaboration Epoch Technology, Collaboration
Epoch Technology and Joint Collaboration Technology to use such technology
solely to the extent necessary or appropriate to carry out Specialty
Laboratories' research and development responsibilities under the Collaboration
in the Field.
(ii) Solely during the Royalty Term, Epoch
grants to Specialty Laboratories a commercial license, subject to the royalty
payments set forth in Section 7.1, granting Specialty Laboratories rights to use
the (w) Pre-Collaboration Epoch Technology, (x) Collaboration Epoch Technology,
(y) Collaboration Specialty Laboratories Technology exclusively licensed to
Epoch pursuant to Section 6(b)(ii) and (z) Joint Collaboration Technology
(including the Joint Collaboration Technology exclusively licensed to Epoch
pursuant to Section 6(b)(i)), to produce distribute and sell the Collaboration
Specialty Laboratories Products (the "Commercial License"). For a period of one
(1) year from the date that products covered by such Commercial License are
commercialized by Specialty Laboratories and offered for sale (the "Exclusivity
Period"), such Commercial License shall be exclusive to Specialty Laboratories
(except with respect to Epoch), provided, however, that Specialty Laboratories
shall be obligated to effect such commercialization within [***]* of such time
that any product covered under such Commercial License is deemed an Effective
Epoch Probe by the parties in good faith, or else there shall be no Exclusivity
Period. For an additional [***]* following the end of the Exclusivity Period, if
Epoch elects to license or sell a product to a third party that is identical to
any Collaboration Specialty Laboratories Product sold by
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7
Specialty Laboratories pursuant to this Commercial License (an "Epoch Commercial
Product"), [***]*.
(iii) Epoch grants to Specialty Laboratories a
perpetual, non- exclusive, royalty-free license to use the Joint Collaboration
Technology exclusively licensed to Epoch pursuant to Section 6(b)(i), and a
perpetual, non-exclusive, royalty-free license to use the Collaboration
Specialty Laboratories Technology exclusively licensed to Epoch pursuant to
Section 6(b)(ii).
(b) GRANT BY SPECIALTY LABORATORIES.
(i) Specialty Laboratories grants to Epoch a
perpetual, exclusive, worldwide, royalty-free license to use the Joint
Collaboration Technology.
(ii) At Epoch's option, Specialty
Laboratories shall grant Epoch an exclusive royalty-bearing license in the
Collaboration Specialty Laboratories Technology, on reasonable terms mutually
agreeable to both parties.
7. FEES AND PAYMENTS.
7.1 RESEARCH ROYALTIES. During the Research Term, Specialty
Laboratories agrees to pay Epoch, on a quarterly basis, payable no later than
the fifth business day of the quarter, [***]* for each Epoch Probe used in a
TaqMan Assay on successful demonstration of assay performance and transfer of no
less than [***]* of the Epoch Probe to Specialty Laboratories.
7.2 ROYALTIES ON COLLABORATION SPECIALTY LABORATORIES
RODUCTS. Specialty Laboratories shall pay to Epoch [***]* of Net Sales.
8. PAYMENTS; RECORDS; AUDITS.
8.1 PAYMENT; REPORTS. Royalty payments and reports for the
sale of Collaboration Specialty Laboratories Products shall be calculated and
reported for each calendar quarter. All royalty payments due to a party under
this Agreement shall be paid within forty-five (45) days of the end of each
calendar quarter. Each payment of royalties shall be accompanied by a report of
Net Sales of Collaboration Specialty Laboratories Products and third party PCR
royalties, in sufficient detail to permit confirmation of the accuracy of the
royalty payment made, including, without limitation, the number of each
Collaboration Specialty Laboratories Product sold, the gross sales and Net Sales
of each Collaboration Specialty Laboratories Product, the royalties, if any, in
U.S. dollars, payable, and any other information necessary to determine the
appropriate amount of royalties due.
8.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments
hereunder shall be payable in U.S. dollars. With respect to each quarter, for
countries other than the United States, whenever conversion of payments from any
foreign currency shall be required, such conversion shall be calculated using
the same exchange rate(s) that the payor uses for its own U.S. dollar financial
statement reporting purposes prepared in accordance with GAAP. All payments owed
under this
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8
Agreement shall be made by wire transfer to a bank and account
designated in writing by the payee, unless otherwise specified by such payee.
8.3 LATE PAYMENTS. In the event that any payment, including
royalty, milestone and research payments, due hereunder is not made within
fifteen (15) days of the date due, the payment shall accrue interest from the
date due at the rate of 1.5% per month; provided, however, that in no event
shall such rate exceed the maximum legal annual interest rate. The payment of
such interest shall not limit a party from exercising any other rights it may
have as a consequence of the lateness of any payment.
8.4 RECORDS AND AUDITS. During the Royalty Term and for a
period of three (3) years thereafter, Specialty Laboratories shall keep complete
and accurate records pertaining to the development and sale or other disposition
of Collaboration Specialty Laboratories Products, in sufficient detail to permit
Epoch to confirm the accuracy of all payments due hereunder. Epoch shall have
the right to cause an independent, certified public accountant reasonably
acceptable to the other to audit such records to confirm Net Sales and royalty
and other payments for a period covering not more than the preceding three (3)
years. Such audits may be exercised during normal business hours once a year
upon at least thirty (30) working days' prior written notice to Specialty
Laboratories. Prompt adjustments shall be made by the parties to reflect the
results of such audit. Epoch shall bear the full cost of such audit unless such
audit discloses an underpayment of more than five percent (5%) from the amount
of royalties or other payments due under this Agreement. In such case, Specialty
Laboratories shall bear the full cost of such audit.
8.5 WITHHOLDING OF TAXES. Any withholding of taxes levied by
tax authorities outside the United States on the payments hereunder shall be
borne by party receiving such payment and deducted by the party making such
payment from the sums otherwise payable by it hereunder for payment to the
proper tax authorities. The parties agrees to cooperate with each other, in the
event a party claims exemption from such withholding or seeks deductions under
any double taxation or other similar treaty or agreement from time to time in
force, such cooperation to consist of providing receipts of payment of such
withheld tax or other documents reasonably available.
8.6 EXCHANGE AND ROYALTY RATE CONTROLS. If at any time legal
restrictions prevent the prompt remittance of part or all royalties with respect
to any country where any Collaboration Specialty Laboratories Product is sold,
payment shall be made through such lawful means or methods as the party making
such payment may determine. When in any country the law or regulations prohibit
both the transmittal and deposit of royalties on sales in such a country,
royalty payments shall be suspended for as long as such prohibition is in
effect, and as soon as such prohibition ceases to be in effect, all royalties
that would have been obligated to be transmitted or deposited, but for the
prohibition, shall forthwith be deposited or transmitted promptly to the extent
allowable, as the case may be. If any royalty rate specified in this Agreement
should exceed the permissible rate established in any country, the royalty rate
for sales in such country shall be adjusted to the highest legally permissible
or government-approved rate.
9. INTELLECTUAL PROPERTY.
9.1 OWNERSHIP OF TECHNOLOGY. Inventorship with respect to
inventions made pursuant to work carried out under the Collaboration shall be
determined in accordance with United States rules of inventorship. Except as
provided below, each party shall own solely all inventions made solely by its
employees and agents, and the parties shall own jointly all inventions jointly
made
9
hereunder. Notwithstanding the foregoing, Epoch shall own all
Pre-Collaboration Epoch Technology and all Collaboration Epoch Technology and
Specialty Laboratories shall own all Pre- Collaboration Specialty Laboratories
Technology and Collaboration Specialty Laboratories Technology.
9.2 PATENT PROSECUTION. Epoch shall be responsible, at its
option, for the filing, prosecution and maintenance of all patent applications
and patents covering any inventions owned jointly by Specialty Laboratories and
Epoch under Section 9 that are useful solely for purposes of this Agreement.
Epoch shall be responsible for the filing, prosecution and maintenance of all
(i) Joint Collaboration Patents, (ii) Collaboration Specialty Laboratories
Patents covering technology licensed under Section 6.1(b)(ii) hereto, and (iii)
Collaboration Epoch Patents. [***]* Each party shall consider in good faith the
requests and suggestions of the other party with respect to strategies for
filing and prosecuting such patent applications. Each party shall keep the other
party informed of progress with regard to the filing, prosecution and
maintenance of patent applications and patents subject to this Section 9.2. In
the event a party is responsible for the filing, prosecution and maintenance of
patent applications or patents hereunder, and elects not to do so, it shall
inform the other party at least sixty (60) days before any relevant deadline for
filing or other action, and such other party shall then have the right to file,
prosecute and maintain such patent applications and patents, in which case the
party declining to continue such activities shall assign all rights in such
patent applications and patents to the other party.
9.3 COOPERATION OF THE PARTIES. Each party agrees to
cooperate fully in the preparation, filing, and prosecution of any patent rights
under this Agreement. Such cooperation includes, but is not limited to:
(a) executing all papers and instruments, or
requiring its employees or agents, to execute such papers and instruments, so as
to effectuate the ownership of patent rights set forth in Section 9.1 above and
to enable the other party to apply for and to prosecute patent applications in
any country; and
(b) promptly informing the other party of any
matters coming to such party's attention that may affect the preparation,
filing, or prosecution of any such patent applications.
9.4 INFRINGEMENT BY THIRD PARTIES. Epoch and Specialty
Laboratories shall promptly notify the other in writing of any alleged or
threatened infringement of any patent included in the Pre-Collaboration
Specialty Laboratories Patents, Collaboration Specialty Laboratories Patents,
Pre-Collaboration Epoch Patents, Collaboration Epoch Patents or Joint
Collaboration Patents of which they become aware. Both parties shall use their
best efforts in cooperating with each other to terminate such infringement
without litigation. Specialty Laboratories shall have the first right to bring
and control any action or proceeding with respect to infringement of a patent
included in the (i) Pre-Collaboration Specialty Laboratories Patents and (ii)
Collaboration Specialty Laboratories Patents covering technology not licensed to
Epoch pursuant to Section 6.1(b)(ii) hereto, useful solely in the Field, at its
own expense and by counsel of its own choice. Epoch shall have the first right
to bring and control any action or proceeding with respect to infringements of a
patent in the (w) Pre-Collaboration Epoch Patents, (x) Collaboration Epoch
Patents, (y) Collaboration Specialty Laboratories Patents covering technology
licensed to Epoch pursuant to Section 6.1(b)(ii), or (z)
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Joint Collaboration Patents, at its own expense and by counsel of its own
choice, and Specialty Laboratories shall have the right, at its own expense, to
be represented in any action involving any patent covering inventions owned
jointly by the parties by counsel of its own choice. If either party fails to
bring an action or proceeding with respect to a patent covering inventions
licensed hereunder within: (a) sixty (60) days following the notice of alleged
infringement or (b) ten (10) days before the time limit, if any, set forth in
the appropriate laws and regulations for the filing of such actions, whichever
comes first, the other party shall have the right to bring and control any such
action at its own expense and by counsel of its own choice, and party initially
declining to bring such action shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice. In the event a
party brings an infringement action, the other party shall cooperate fully,
including if required to bring such action, the furnishing of a power of
attorney. Neither party shall have the right to settle any patent infringement
litigation under this Section 9.4 in a manner that diminishes the rights or
interests of the other party without the consent of such other party. Except as
otherwise agreed to by the parties as part of a cost sharing arrangement, any
recovery realized as a result of such litigation, after reimbursement of any
litigation expenses of Specialty Laboratories and Epoch, shall belong to the
party who brought the action.
9.5 INFRINGEMENT OF THIRD PARTY RIGHTS. Each party shall
promptly notify the other in writing of any allegation by a Third Party that the
activity of either of the parties hereunder infringes or may infringe the
intellectual property rights of such Third Party.
Specialty Laboratories shall have the first right to control any defense
of any such claim involving alleged infringement of Third Party rights by
Specialty Laboratories' activities under this Agreement at its own expense and
by counsel of its own choice, and Epoch shall have the right, at its own
expense, to be represented in any such action by counsel of its own choice. If
Specialty Laboratories fails to proceed in a timely fashion with regard to such
defense, Epoch shall have the right to control any such defense of such claim at
its own expense and by counsel of its own choice, and Specialty Laboratories
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice.
Epoch shall have the first right to control any defense of any such
claim involving alleged infringement of Third Party rights by Epoch's activities
under this Agreement at its own expense and by counsel of its own choice, and
Specialty Laboratories shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice. If Epoch fails to
proceed in a timely fashion with regard to such defense, Specialty Laboratories
shall have the right to control any such defense of such claim at its own
expense and by counsel of its own choice, and Epoch shall have the right, at its
own expense, to be represented in any such action by counsel of its own choice.
Neither party shall have the right to settle any patent infringement
litigation under this Section 9.5 in a manner that diminishes the rights or
interests of the other party without the consent of such party.
9.6 TRADEMARKS. Specialty Laboratories and Epoch shall each
obtain, own and enforce its own trademarks with respect to Collaboration
Specialty Laboratories Products or Epoch products that each commercializes
hereunder.
9.7 PATENT LABELING. Specialty Laboratories shall xxxx all
Collaboration Specialty Laboratories Products or their containers that are
manufactured used or sold under the terms of this Agreement in accordance with
the appropriate patent markings laws.
11
10. REPRESENTATIONS AND WARRANTIES.
10.1 REPRESENTATIONS AND WARRANTIES. Each party represents to
the other that:
(a) The Epoch Probes are provided to Specialty
Laboratories for internal evaluation purposes only and will be used only by
Specialty Laboratories in its laboratories, and will not be transferred,
distributed or released to any third party. Specialty Laboratories will follow
all applicable governmental regulations and guidelines in the handling and use
of the Epoch Probes.
(b) The Epoch Probes provided to Specialty
Laboratories hereunder will not be used for testing in, treatment of, or
diagnosis of humans unless and until Specialty receives all necessary
governmental and regulatory approvals. Obtaining such approvals shall be the
sole responsibility of Specialty Laboratories. In the event Specialty
Laboratories obtains any such approvals it shall provide to Epoch all
information and documentation thereto and permit Epoch to use such information
and documentation to obtain for itself or its licensees or customers approvals
to use the such Epoch Probes outside the Field. Specialty Laboratories shall
also grant Epoch a right of reference to Specialty Laboratories' regulatory
filings for such purpose.
(c) CORPORATE POWER. It is duly organized and
validly existing under the laws of its state of incorporation or formation, and
has full corporate power and authority to enter into this Agreement and to carry
out the provisions hereof.
(d) DUE AUTHORIZATION. It is duly authorized to
execute and deliver this Agreement and to perform its obligations hereunder, and
the person or persons executing this Agreement on its behalf has been duly
authorized to do so by all requisite corporate action.
(e) BINDING AGREEMENT. This Agreement is legally
binding upon it, enforceable in accordance with its terms. The execution,
delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.
(f) GRANT OF RIGHTS; MAINTENANCE OF AGREEMENTS. It
has not, and will not during the term of this Agreement, grant any right to any
third party that would conflict with the rights granted to the other party
hereunder. It has (or will have at the time performance is due) maintained and
will maintain and keep in full force and effect all agreements (including
license agreements) and filings (including patent filings) necessary to perform
its obligations hereunder.
(g) VALIDITY. It is aware of no action, suit or
inquiry or investigation instituted by or before any court or governmental
agency that questions or threatens the validity of this Agreement or of any
Collaboration Specialty Laboratories Patents and Collaboration Epoch Patents.
10.2 EPOCH REPRESENTATIONS AND WARRANTIES. Epoch represents
and warrants that:
(a) it is the sole and exclusive owner of the
Pre-Collaboration Epoch Technology and has sufficient rights and power to grant
the licenses to Specialty Laboratories which it purports to grant herein;
12
(b) the Pre-Collaboration Epoch Technology are free
of any encumbrances, liens, licenses, judgments and/or security interests that
would affect the exercise by Specialty Laboratories of its rights in the Field;
and
(c) it has no knowledge of any outstanding and
unresolved claim or accusation that any products manufactured, used or sold by
Epoch and licensed hereunder or any methods or process practiced by Epoch
infringes or may infringe any third party patent(s) or other intellectual
property rights.
10.3 SPECIALTY LABORATORIES REPRESENTATIONS AND WARRANTIES.
Specialty Laboratories represents and warrants that:
(a) it owns the Pre-Collaboration Specialty
Laboratories Technology and has sufficient rights and power to grant the
licenses to Epoch which it purports to grant herein;
(b) it has no knowledge of any outstanding and
unresolved claim or accusation that any methods or process practiced by
Specialty Laboratories as part of the Specialty Laboratories Technology
infringes or may infringe any third party patent(s) or other intellectual
property rights; and
(c) it has obtained a valid license to use PCR
technology and perform TaqMan Assays in the Field without infringing any
intellectual property rights or other proprietary rights of any third party.
10.4 DISCLAIMER CONCERNING TECHNOLOGY. EXCEPT AS SPECIFICALLY
SET FORTH HEREIN, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY
EACH PARTY HEREUNDER IS PROVIDED "AS IS" AND EACH PARTY EXPRESSLY DISCLAIMS ANY
AND ALL WARRANTIES 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 ARISING
FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT
THERETO. Without limiting the generality of the foregoing, each party expressly
does not warrant (a) the success of any study or test commenced under the
Collaboration or (b) the safety or usefulness for any purpose of the technology
it provides hereunder.
It is understood that any Epoch Probes provided hereunder are
experimental in nature. EPOCH DOES NOT MAKE ANY REPRESENTATIONS OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING ANY REPRESENTATION WITH RESPECT TO SAFETY,
EFFICACY, MERCHANTABILITY, FITNESS FOR ANY PURPOSE OR NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS, WITH RESPECT TO THE PRODUCT OR INFORMATION
PROVIDED HEREUNDER.
11. CONFIDENTIALITY; PUBLICATION.
11.1 CONFIDENTIALITY. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing by the parties, the
parties agree that, during the Royalty Term and for five (5) years thereafter,
the receiving party shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as expressly provided for
in this Agreement any
13
Confidential Information furnished to it by the other party pursuant to this
Agreement. Each party may use such Confidential Information only to the extent
required to accomplish the purposes of this Agreement. Each party will use at
least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that its employees, agents,
consultants and other representatives do not disclose or make any unauthorized
use of the Confidential Information. Each party will promptly notify the other
upon discovery of any unauthorized use or disclosure of the Confidential
Information.
11.2 EXCEPTIONS. Confidential Information shall not include
any information which the receiving party can prove by competent evidence:
(a) is now, or hereafter becomes, through no act or
failure to act on the part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of
receiving such information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by
a Third Party, as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving
party without the aid, application or use of Confidential Information of the
disclosing party; or
(e) is the subject of a written permission to
disclose provided by the disclosing party.
11.3 TERMS OF AGREEMENT. The parties agree that this
Agreement and the terms hereof will be considered Confidential Information of
both parties. Notwithstanding the foregoing, either party may disclose such
terms as are required to be disclosed under strictures of confidentiality to
bona fide potential sublicensees or for fund raising efforts to investors and
potential investors or as otherwise required pursuant to applicable law.
11.4 AUTHORIZED DISCLOSURE. Each party may disclose
Confidential Information belonging to the other party to the extent such
disclosure is reasonably necessary in the following instances:
(a) filing or prosecuting patents relating to the
Collaboration;
(b) regulatory filings;
(c) prosecuting or defending litigation;
(d) complying with applicable court orders or
governmental regulations;
(e) conducting pre-clinical or clinical trials of
Collaboration Epoch Probes; and
(f) disclosure to Affiliates, sublicensees,
employees, consultants, agents or other Third
14
Parties in connection with due diligence or similar investigations by such Third
Parties, in each case who agree to be bound by similar terms of confidentiality
and non-use at least equivalent in scope to those set forth in this Article 11.
Notwithstanding the foregoing, in the event a party is required to make
a disclosure of the other party's Confidential Information pursuant to this
Section 11.4, it will seek to secure confidential treatment of such information
at least as diligently as such party would use to protect its own confidential
information. The parties will consult with each other on the provisions of this
Agreement to be redacted in any filings made by the parties with the Securities
and Exchange Commission or as otherwise required by law.
11.5 PUBLICATIONS. Each party to this Agreement recognizes
that the publication of papers regarding results of and other information
regarding the Collaboration, including oral presentations and abstracts, may be
beneficial to both parties provided such publications are subject to reasonable
controls to protect Confidential Information. Accordingly, the each party shall
have the right to review and approve any paper proposed for publication by the
other party, including oral presentations and abstracts, which utilizes data
generated from the Collaboration and/or includes Confidential Information of the
other party. Before any such paper is submitted for publication, the party
proposing publication shall deliver a complete copy to the other party at least
forty-five (45) days prior to submitting the paper to a publisher. Such other
party shall review any such paper and give its comments to the publishing party
within thirty (30) days of its receipt of such paper. With respect to oral
presentation materials and abstracts, the reviewing party shall make reasonable
efforts to expedite review of such materials and abstracts, and shall return
such items as soon as practicable to the publishing party with appropriate
comments, if any, but in no event later than thirty (30) days from the date of
receipt by the reviewing party. The publishing party shall comply with the
reviewing party's request to delete references to the other party's Confidential
Information in any such paper and agrees to withhold publication of same for an
additional ninety (90) days in order to permit the parties to obtain patent
protection, if either of the parties deems it necessary, in accordance with the
terms of this Agreement.
12. TERM AND TERMINATION.
12.1 TERM OF THE AGREEMENT. The term of the collaborative
activities of the parties pursuant to the Collaboration shall commence on the
Effective Date and continue until expiration of the Research Term, unless
earlier terminated pursuant to Section 12.2, 12.3 or 12.4, or extended by mutual
agreement of the parties. The term of this Agreement (the "Term of the
Agreement") shall commence on the Effective Date and continue until six (6)
months after the expiration of the last Royalty Term for any Collaboration
Specialty Laboratories Product or Epoch Product, unless earlier terminated
pursuant to Section 12.2, 12.3 or 12.4 or extended upon terms mutually agreeable
to both parties.
12.2 TERMINATION BY MUTUAL AGREEMENT. The parties may at any
time terminate this Agreement by written agreement executed by both Specialty
Laboratories and Epoch.
12.3 TERMINATION BY SPECIALTY LABORATORIES. Specialty
Laboratories may terminate this Agreement by giving ninety (90) days prior
written notice to Epoch, but in no event may Specialty Laboratories terminate
this Agreement pursuant to this Section 12.3 prior to the first anniversary of
the Effective Date hereof.
15
12.4 TERMINATION FOR CAUSE. Each party shall have the right
to terminate this Agreement upon sixty (60) days' prior written notice to the
other upon the occurrence of any of the following:
(a) Upon or after the bankruptcy, insolvency,
dissolution or winding up of the other party (other than a dissolution or
winding up for the purpose of reconstruction or amalgamation); or
(b) Upon or after the breach of any material
provision of this Agreement by the other party if the breaching party has not
cured such breach within the sixty (60) day period following written notice of
termination by the non-breaching party.
All licenses granted to the non-breaching party under Sections 6.1 and
6.2 of this Agreement shall survive such termination for so long as such
non-breaching party is not in breach of its obligations to the other party under
this Agreement.
12.5 ACCRUED RIGHTS, SURVIVING OBLIGATIONS.
(a) Expiration or termination of this Agreement
shall not affect any rights or obligations of either party accruing prior to
such expiration or termination. The terms of this Section 12.5 and Sections
6.1(b), 8, 9.1, 9.3, 10, 11.1, 11.2, 11.3, 11.4, 12.4, 13, 14 and 15 of this
Agreement shall survive expiration or termination of this Agreement. Promptly
after termination of this Agreement each party (other than a non-breaching party
that retains a license as described in Section 12.4) shall return or dispose of
any technology or know-how of the other in the accordance with the instructions
of the other, including without limitation any assays or other biological or
chemical materials.
13. INDEMNITY.
13.1 INDEMNIFICATION. Each party hereby agrees to save,
defend and hold the other party and its directors, officers, employees, and
agents harmless from and against any and all claims, suits, actions, demands,
liabilities, expenses and/or loss, including reasonable legal expense and
attorneys' fees (collectively, "Claims") for damage to persons or property
resulting directly or indirectly from actions in connection with the
Collaboration by the indemnifying party, its Affiliates, agents or sublicensees,
but only to the extent such Claims result from the gross negligence or willful
misconduct of the indemnifying party or its Affiliates, agents or sublicensees
and do not result from the negligence of the party seeking indemnification.
13.2 CONTROL OF DEFENSE. Any entity entitled to
indemnification under this Section 13 shall give notice to the indemnifying
party of any Claims that may be subject to indemnification, promptly after
learning of such Claim, and the indemnifying party shall assume the defense of
such Claims with counsel reasonably satisfactory to the indemnified party. If
such defense is assumed by the indemnifying party with counsel so selected, the
indemnifying party will not be subject to any liability for any settlement of
such Claims made by the indemnified party without its consent (but such consent
will not be unreasonably withheld or delayed), and will not be obligated to pay
the fees and expenses of any separate counsel retained by the indemnified party
with respect to such Claims.
16
13.3 INSURANCE. Specialty Laboratories, at its own expense,
shall maintain product liability insurance (or self-insure) in amounts
consistent with industry standards for other such clinical laboratories during
the Term of the Agreement and shall name Epoch as an additional insured with
respect to such insurance. Specialty Laboratories shall provide a certificate of
insurance (or evidence of self-insurance) evidencing such coverage.
14. GOVERNING LAW; DISPUTE RESOLUTION.
14.1 GOVERNING LAW. This Agreement shall be governed by the
laws of the State of Washington as such laws are applied to contracts entered
into or to be performed entirely within such state.
14.2 LEGAL COMPLIANCE. Within thirty (30) days of the date
hereof, the parties shall review in good faith and cooperate in taking such
actions to ensure compliance of this Agreement with all applicable laws.
14.3 DISPUTE RESOLUTION. Except as provided in Section 2.6,
and except with respect to matters pertaining to injunctive relief, in the event
of any dispute, the parties shall refer such dispute to the Chief Executive
Officer of Epoch and the President, Research and Development of Specialty
Laboratories for attempted resolution by good faith negotiations within sixty
(60) days after such referral is made. During such period of good faith
negotiations, any applicable time periods under this Agreement shall be tolled.
In the event such executives are unable to resolve such dispute within such
sixty (60) day period, the parties shall submit their dispute to binding
arbitration administered by the American Arbitration Association ("AAA") located
in Seattle, Washington, such arbitration to be conducted pursuant to the AAA
procedure rules for commercial disputes then in effect. The award of the
arbitrator shall include an award of reasonable attorneys' fees and costs to the
prevailing party.
14.4 JURISDICTION AND VENUE. Except as provided in Section
2.7 or 14.3 above, any claim or controversy arising out of or related to this
Agreement or any breach hereof (including claims for injunctive relief) shall be
adjudicated in the state and federal courts in Seattle, Washington having
jurisdiction over disputes arising in the State of Washington, and the parties
hereby consent to the jurisdiction and venue of such courts.
15. GENERAL PROVISIONS.
15.1 NOTICES. All notices required or permitted to be given
under this Agreement shall be in writing and shall be mailed by registered or
certified mail, Federal Express or other nationally recognized overnight
delivery service, addressed to the signatory to whom such notice is required or
permitted to be given and transmitted by facsimile to the number indicated
below. All notices shall be deemed to have been given when mailed, as evidenced
by the postmark at the point of mailing, or faxed.
All notices to Specialty Laboratories
shall be addressed as follows: Xxxxx X. Xxxxx, M..D., Ph.D.
Chairman and CEO
0000 Xxxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000
17
with a copy to: Xxxxx Xxxxxxx, M.D.
Director, Special Research
Projects
0000 Xxxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000
All notices to Epoch shall be
addressed to: Xxxxxxx X. Xxxxxx, M.D.
Chief Executive Officer
00000 000xx Xxxxx X.X., #000
Xxxxxxx, XX 00000
with a copy to: Xxxxxxx X. Xxxxxxxx
President and Chief Financial
Officer
000 Xxxxxxx Xxxxxx, Xxxxx 000
Xxx Xxxxxxxxx, XX 00000
Any party may, by written notice to the other, designate a new address or fax
number to which notices to the party giving the notice shall thereafter be
mailed or fixed.
15.2 FORCE MAJEURE. No party shall be liable for any delay or
failure of performance (other than payment obligations) to the extent such delay
or failure is caused by circumstances beyond its reasonable control and that by
the exercise of due diligence it is unable to prevent, provided that the party
claiming excuse uses its best efforts to overcome the same.
15.3 ENTIRETY OF AGREEMENT. This Agreement embodies the
entire, final and complete agreement and understanding between the parties and
replaces and supersedes all prior discussions and agreements between them with
respect to its subject matter, except for the September 24, 1997 Collaboration
Agreement, which shall continue in accordance with its terms, except to the
extent specifically modified hereby. No modification or waiver of any terms or
conditions hereof shall be effective unless made in writing and signed by a duly
authorized officer of each party.
15.4 NON-WAIVER. The failure of a party in any one or more
instances to insist upon strict performance of any of the terms and conditions
of this Agreement shall not constitute a waiver or relinquishment, to any
extent, of the right to assert or rely upon any such terms or conditions on any
future occasion.
15.5 DISCLAIMER OF AGENCY. Neither party is, or will be
deemed to be, the legal representative or agent of the other, nor shall either
party have the right or authority to assume, create, or incur any third party
liability or obligation of any kind, express or implied, against or in the name
of or on behalf of another except as expressly set forth in this Agreement.
15.6 SEVERABILITY. If a court of competent jurisdiction
declares any provision of this Agreement invalid or unenforceable, or if any
government or other agency having jurisdiction over either Epoch or Specialty
Laboratories deems any provision to be contrary to any laws, then that provision
shall be severed and the remainder of the Agreement shall continue in full force
and effect. To the extent possible, the parties shall revise such invalidated
provision in a manner that will render such provision valid without impairing
the parties' original intent.
18
15.7 AFFILIATES; ASSIGNMENT. Except as otherwise provided
herein, neither party may assign its rights or delegate its duties under this
Agreement without the prior written consent of the other party, not to be
unreasonably withheld. Notwithstanding the foregoing, each party may assign this
Agreement to any of its Affiliates, to a special purpose corporation or similar
entity at least fifty percent (50%) of the outstanding shares of any class or
series of stock of which is owned by such party in a manner such that the
assignor will remain liable and responsible for the performance and observance
of all its duties and obligations hereunder without the consent of the other
party. In addition, the consent of the other party will not be required in
connection with a merger involving either party or with respect to an assignment
of this Agreement in connection with, as the case may be, the acquisition, sale
of all or substantially all of the assets of either party, or a change of
control or similar transaction. This Agreement shall be binding upon the
successors and permitted assigns of the parties. Any attempted delegation or
assignment not in accordance with this Section 15.7 shall be of no force or
effect.
15.8 HEADINGS. The headings contained in this Agreement are
inserted for reference only and shall not be deemed a part of the text hereof.
15.9 LIMITATION OF LIABILITY. NO PARTY SHALL BE LIABLE TO
ANOTHER FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES,
INCLUDING BUT NOT LIMITED TO LOST PROFITS, ARISING FROM OR RELATING TO ANY
BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH
DAMAGES. Nothing in this Section is intended to limit or restrict the
indemnification rights or obligations of any party.
15.10 COUNTERPARTS. This Agreement may be executed in one or
more counterparts, each of which shall be an original and all of which shall
constitute together the same document.
15.11 BANKRUPTCY. All rights and licenses granted under this
Agreement will be considered for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to "intellectual property" as defined under Section
101(56) of the Bankruptcy Code. The parties agree that a licensee of such rights
under this Agreement will retain and may fully exercise all of its rights and
elections under the Bankruptcy Code. In the event that a licensor seeks or is
involuntarily placed under the protection of the Bankruptcy Code, and the
trustee in bankruptcy rejects this Agreement, the licensee hereby elects,
pursuant to Section 365(n), to retain all rights granted to it under this
Agreement to the extent permitted by the law.
15.12 PUBLIC DISCLOSURE. Except for such disclosure as is
deemed necessary, in the reasonable judgment of a party, to comply with
applicable laws or regulations, no public announcement, news release, public
statement or publication relating to the existence of this Agreement, or the
terms hereof, will be made without the other party's prior written approval,
which approval shall not be unreasonably withheld. The parties agree that they
will use reasonable efforts to coordinate the initial announcement or press
release relating to the existence of this Agreement, so that such initial
announcement or press release by each is made contemporaneously.
19
IN WITNESS WHEREOF, the parties hereto have duly executed this
Agreement.
EPOCH PHARMACEUTICALS, INC.
(doing business as Epoch Biosciences)
By
----------------------------------------
Title Chief Executive Officer
--------------------------------------
SPECIALTY LABORATORIES, INC.
By
----------------------------------------
Title
--------------------------------------
20
EXHIBIT A
RESEARCH PLAN
21
EXHIBIT B
PATENTS AND APPLICATIONS
I. PRE-COLLABORATION EPOCH PATENTS:
A. PATENTS
-------------------- ------------------------------------------------------------------------------ ------------------
EPOCH NO. TITLE U.S. PATENT NO.
-------------------- ------------------------------------------------------------------------------ ------------------
114B Solid Support for the Synthesis of 3'-Tailed Oligonucleotides 5,419, 966
-------------------- ------------------------------------------------------------------------------ ------------------
114D Trifunctional Intermediates for Preparing 3'-Tailed Oligonucleotides 5,512,667
-------------------- ------------------------------------------------------------------------------ ------------------
116E Crosslinking Olgonucleotides 5,824,796
-------------------- ------------------------------------------------------------------------------ ------------------
137 Covalently Linked Oligonucleotide Minor Groove Binder Conjugates 5,801,155
-------------------- ------------------------------------------------------------------------------ ------------------
B. ALLOWED APPLICATIONS
-------------------- ------------------------------------------------------------------------------ ------------------
EPOCH NO. TITLE FILING DATE
-------------------- ------------------------------------------------------------------------------ ------------------
137B [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
146 [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
C. PENDING APPLICATIONS
-------------------- ------------------------------------------------------------------------------ ------------------
EPOCH NO. TITLE FILING DATE
-------------------- ------------------------------------------------------------------------------ ------------------
137A [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
137C [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
146A [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
----------
* PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
22
B.
PENDING APPLICATIONS (CONT.D)
-------------------- ------------------------------------------------------------------------------ ------------------
148 [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
150 [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
151 [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
153 [***]* [***]*
-------------------- ------------------------------------------------------------------------------ ------------------
II. PRE-COLLABORATION SPECIALTY LABORATORIES PATENTS
----------
* PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
23
EXHIBIT C
MATERIALS TRANSFER AGREEMENT
EFFECTIVE DATE: MAY 9, 2000
Epoch Pharmaceuticals, Inc. (doing business as Epoch Biosciences) whose
principal offices are located at 00000 000xx Xxxxx, #000, Xxxxxxx, Xxxxxxxxxx
00000, agrees to provide certain research substances and associated property
(hereinafter "MATERIALS", as further described below), under the following
conditions:
1. The parties to this Agreement are: Epoch Pharmaceuticals, Inc.
(hereinafter "PROVIDER") and Specialty Laboratories (hereinafter called
RECIPIENT).
2. The MATERIALS that are covered by this Agreement include:
(a) Nucleic acid sequence detection probes incorporating Minor
Groove Bonders (MGBs), modified nucleotides and other Epoch
technology for use in specified TaqMan Assays for the detection
of human leukemias.
(b) any confidential disclosure, written, oral or visual, pertaining
to the production, purification, or use of said MATERIALS. The
MATERIALS are considered proprietary to PROVIDER.
3. RECIPIENT may conduct IN VITRO studies, as appropriate, using MATERIALS
that may be provided by PROVIDER, from time to time, under the terms of this
Agreement. RECIPIENT shall use the MATERIALS in compliance with all laws and
regulations, including but not limited to current EPA, FDA, USDA, and NIH
guidelines. The MATERIALS or derivatives thereof are supplied solely for IN
VITRO research purposes. THE MATERIALS WILL NOT BE USED IN HUMANS. RECIPIENT
will not provide the MATERIALS to third parties, including but not limited to,
persons working or consulting for partnerships, joint ventures, or other
organizations performing research or intending to perform research or product
development in this field. In the event of termination of this Agreement, either
upon the expiration of its term or at any time earlier, RECIPIENT shall, upon
written request by PROVIDER, return or destroy, at PROVIDER's option, any and
all MATERIALS received from PROVIDER in the possession of or under the control
of RECIPIENT. RECIPEINT shall provide written confirmation to PROVIDER of such
return or destruction.
4. Subject to the terms and conditions herein provided, this Agreement
shall commence on the Effective Date of the Collaborative Research, Development
and License Agreement simultaneously executed by the Parties, and shall be
subject to the termination provisions contained in Section 12 therein. The terms
of paragraph 3 as regarding ownership and paragraphs 5, 6, 7, 8, and 9 shall
survive termination of this Agreement.
5. PROVIDER's Confidential Information shall include MATERIALS furnished by
PROVIDER. The Parties agree to be bound by the confidentiality provisions of
Section 11 of
24
the Collaborative Research, Development and License Agreement
simultaneously executed by the Parties.
6. Inventions shall include all discoveries, concepts and ideas,
whether patentable or not, which arise from or are directly related to the
MATERIALS and Confidential Information, including but not limited to articles,
processes, compounds, methods, formulae, systems and techniques, as well as
improvements thereof and relating to the MATERIALS. The Parties agree to be
bound by the Intellectual Property provisions of Section 9 of the Collaborative
Research, Development and License Agreement simultaneously executed by the
Parties.
7. Each party agrees to indemnify, defend, and hold the other party
harmless from and against any loss, claim, damage, or liability of any kind
involving an action or inaction of the first party arising out of or in
connection with this Agreement.
8. NEITHER PARTY MAKES ANY WARRANTIES EITHER EXPRESS OR IMPLIED, AS
TO ANY MATTER, INCLUDING, WITHOUT LIMITATION, THE RESULTS OF THE RESEARCH OR ANY
INVENTIONS OR PRODUCT, TANGIBLE OR INTANGIBLE, CONCEIVED, DISCOVERED, OR
DEVELOPED UNDER THIS AGREEMENT; OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS
FOR A PARTICULAR PURPOSE OF THE RESEARCH RESULTS OR OF ANY SUCH INVENTION OR
PRODUCT. Neither party shall be liable for any direct, consequential, or other
damages suffered by the other party or any others resulting from the use of the
research results or any such invention or product.
9. Neither party shall be liable for any failure to perform as
required by this Agreement, to the extent such failure to perform is caused by
any reason beyond the other party's control, or by reason of any of the
following: labor disturbances or disputes of any kind, accidents, failure of any
required governmental approval, civil disorders, acts of aggression, acts of
God, energy or other conservation measures, failure of utilities, mechanical
breakdowns, material shortages, disease, or similar occurrences.
10. This Agreement shall be governed by the laws of the State of
Washington.
16. This Agreement, except as supplemented or modified in writing
between the parties, constitutes the entire agreement between the parties with
respect to the terms and scope of this Agreement. Neither party may assign this
Agreement without the prior written consent of the other party, such consent not
unreasonably withheld. The provisions of this Agreement may not be waived or
modified except by a writing signed by the party against whom enforcement is
sought. No waiver of breach shall constitute a subsequent waiver of any
subsequent breach, and if any provision of this Agreement be invalid, the
remaining provisions shall remain enforceable.
25
PROVIDER: RECIPIENT:
EPOCH PHARMACEUTICALS, INC. SPECIALTY LABORATORIES
(doing business as Epoch 0000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxx) Xxxxx Xxxxxx, XX 00000
00000 000xx Xxxxx XX, #000
Xxxxxxx, Xxxxxxxxxx 00000
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Authorized Signature Authorized Signature
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Name Name
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Title Title
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Date Date
26
