***CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT (INDICATED BY
ASTERISKS) HAS BEEN OMITTED AND FILED
SEPRATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER 17 C.F.R.
SECTIONS 200.80(b)(4) AND 240.24b-2
Exhibit 10.36
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "Agreement") is made as of September 3,
2004 (the "Effective Date"), by and between ANADYS PHARMACEUTICALS, INC., a
Delaware corporation with its offices at 0000 Xxxxxxxxxx Xxx, Xxx Xxxxx, XX
00000, XXX ("Anadys") and APHOENIX, INC., a Japanese corporation with its
registered principal place of business at 0-00-00, Xxxxxxx, Xxxxxxx-xx, Xxxxx
000-000, Xxxxx ("Aphoenix").
RECITALS
WHEREAS, Aphoenix has [...***...] ([...***...]) drug targets (the
"Aphoenix Targets") against which it desires that Anadys use ATLAS(TM) to screen
[...***...] ([...***...]) compounds from the Aphoenix Library (the "Aphoenix
Library Compounds") and [...***...] ([...***...]) compounds from the Anadys
Library (the "Anadys Library Compounds") during the Collaboration; and
WHEREAS, Anadys desires to utilize ATLAS(TM) to screen the Aphoenix
Targets against the Aphoenix Library Compounds and the Anadys Library Compounds
in order to identify for Aphoenix those compounds which are most likely to show
activity in relation to the Aphoenix Targets and for further research and
optimization to generate compounds for potential preclinical and clinical
development, manufacturing and commercialization.
NOW, THEREFORE, in consideration of the foregoing premises and the
covenants set forth below, the Parties hereby agree as follows:
1. DEFINITIONS
1.1 "AFFILIATE" means, with respect to a Party, an entity that, directly
or indirectly, through one or more intermediaries, controls, is controlled by or
is under common control with such Party.
1.2 "ANADYS LIBRARY COMPOUNDS" means the approximately [...***...]
([...***...]) small molecule compounds from Anadys' compound library that may be
utilized pursuant to the terms of this Agreement, each of which is an "Anadys
Library Compound".
1.3 "ANADYS LIBRARY LEAD COMPOUND" means a Lead Compound that originated
as an Anadys Library Compound.
1.4 "ANADYS LIBRARY VALIDATED HIT" means a Validated Hit that is an
Anadys Library Compound.
1.5 "APHOENIX LIBRARY COMPOUNDS" means the approximately [...***...]
([...***...]) small molecule compounds from Aphoenix's compound library,
supplied to Anadys
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1.
hereunder and that may be utilized pursuant to the terms of this Agreement, each
of which is an "Aphoenix Library Compound".
1.6 "APHOENIX LIBRARY LEAD COMPOUND" means a Lead Compound that
originated as an Aphoenix Library Compound.
1.7 "APHOENIX LIBRARY VALIDATED HIT" means a Validated Hit that is an
Aphoenix Library Compound.
1.8 "ASSAY TECHNOLOGY" means all inventions, discoveries, works of
authorship, trade secrets and other know-how or developments, including
observations, conclusions, hypotheses, identifications, data and other
information, and all intellectual property rights (including co-invented or
sole-invented patent rights) appurtenant thereto, that are made, conceived,
reduced to practice, authored, or otherwise generated or obtained directly or
indirectly by one or both Parties in whole or in part in the course of
performance of the Work Plan that are modifications or improvements of screening
assay technology, including assay design, development, validation,
implementation, application, and performance, that are generally useful for
screening assays, including modifications or improvements of ATLAS(TM) screening
technology (which may include those relating to ATLAS(TM) design, implementation
or application).
1.9 "ATLAS" means Anadys' proprietary affinity based screening
technology.
1.10 "COLLABORATION" means the research to be conducted pursuant to this
Collaboration Agreement as set forth in Section 2.3.
1.11 "COLLABORATION PRODUCT" means any pharmaceutical composition of a
Lead Compound.
1.12 "[...***...] TARGET" means the [...***...] Target provided by
Aphoenix to Anadys for screening under this Agreement.
1.13 "[...***...] TARGET" means the [...***...] Target provided by
Aphoenix to Anadys for screening under this Agreement.
1.14 "FTE" means the equivalent of a full-time [...***...] (including
[...***...][...***...] days, [...***...] days and [...***...]) work of a person,
carried out by one (1) or more employees or consultants of a Party.
1.15 "INFECTIOUS DISEASE COLLABORATION AGREEMENT" means an Agreement
entered into by and between Anadys and Aphoenix in accordance with the
procedures set forth in Section 4.1(b), which agreement shall set forth the
Parties rights with respect to one or more Infectious Disease Target Validated
Hits, and the terms of which shall supersede and replace the terms set forth in
Sections 5, 6.2 and 6.3 of this Agreement with respect to such Infectious
Disease Target Validated Hit(s).
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2.
1.16 "INFECTIOUS DISEASE TARGET" means a Target designated by Aphoenix
for screening under the Collaboration that is a drug discovery target for an
infectious disease.
1.17 "INFECTIOUS DISEASE TARGET ASSAY" means an assay for use with
ATLAS(TM) for an Infectious Disease Target that Anadys develops under the Work
Plan as described in Section 2.3(a).
1.18 "INFECTIOUS DISEASE TARGET LEAD COMPOUND" means an Infectious
Disease Target Validated Hit or a derivative of an Infectious Disease Target
Validated Hit generated by the introduction of one or more structural changes
into an Infectious Disease Target Validated Hit and that is designated by
Aphoenix, an Affiliate or a Third Party as a compound to be pursued for further
research and development, either by Aphoenix and/or its Affiliates and/or a
Third Party.
1.19 "INFECTIOUS DISEASE TARGET VALIDATED HIT" means an Anadys Library
Compound or an Aphoenix Library Compound that in an Infectious Disease Target
Assay yields results that meet the Target Assay Criteria.
1.20 "JOINT RESEARCH COMMITTEE" or "JRC" shall have the meaning given
such term in Section 2.2(a).
1.21 "LEAD COMPOUND" means a Validated Hit or a derivative of a Validated
Hit generated by the introduction of one or more structural changes into a
Validated Hit and that is designated by Aphoenix, an Affiliate or a Third Party
as a compound to be pursued for further research and development, either by
Aphoenix and/or its Affiliates and/or a Third Party. For clarity, a Lead
Compound can be either an Anadys Library Lead Compound or an Aphoenix Library
Lead Compound.
1.22 "PARTICIPATION NOTICE" means a written notice that Anadys, at its
sole discretion, may provide to Aphoenix pursuant to Section 4.1(a) of this
Agreement, which shall specify Anadys' desire to further collaborate with
Aphoenix around a particular Infectious Disease Target Validated Hit.
1.23 "PATENT" means (a) United States patents, reexaminations, reissues,
renewals, extensions and term restorations, and foreign counterparts thereof,
and (b) pending applications for United States patents, including, without
limitation, provisional applications, continuations, continuations-in-part,
divisional and substitute applications, including without limitations,
inventors' certificates, and foreign counterparts THEREOF.
1.24 "RESEARCH RESULTS" means all inventions, discoveries, works of
authorship, trade secrets and other know-how or developments, including
observations, conclusions, hypotheses, identifications, data and other
information, and all intellectual property rights (including co-invented or
sole-invented patent rights) appurtenant thereto, that are made, conceived,
reduced to practice, authored, or otherwise generated or obtained directly or
indirectly by one or both Parties in whole or in part in the course of
performance of this Agreement, excluding Assay Technology.
3.
1.25 "TARGET" means the adequate protein chosen by Aphoenix, at its sole
discretion, and provided to Anadys pursuant to the terms of the Agreement,
including, but not limited to, the [...***...] Target the [...***...] Target and
the [...***...] Target.
1.26 "TARGET ASSAY" means an assay for use with ATLAS(TM) for a
particular Target that Anadys develops under the Work Plan as described in
Section 2.3(a).
1.27 "TARGET ASSAY CRITERIA" means, as established by the JRC pursuant to
Section 2.3, the minimum or qualitative results from a Target Assay for an
Anadys Library Compound or Aphoenix Library Compound that qualify such Anadys
Library Compound or Aphoenix Library Compounds as a Validated Hit.
1.28 "THIRD PARTY" means any person or entity other than Aphoenix, Anadys,
and their respective Affiliates.
1.29 "[...***...] TARGET" means the [...***...] Target provided by
Aphoenix to Anadys for screening under this Agreement.
1.30 "VALIDATED HIT" means an Anadys Library Compound or an Aphoenix
Library Compound that in a Target Assay yields results that meet the Target
Assay Criteria.
2. COLLABORATION WORK
2.1 WORK PLAN AND GENERAL OBLIGATIONS. The Parties have agreed upon the
work plan for the Collaboration (the "WORK PLAN") attached hereto as Exhibit A,
which sets forth the specific activities that Anadys will undertake under this
Agreement. The Work Plan may be amended from time to time in writing by the
parties. Notwithstanding the foregoing, the parties hereby agree that the
Collaboration shall include the screening of [...***...] ([...***...]) Targets
provided by Aphoenix to Anadys and that the Collaboration work will be conducted
over a thirty-six (36) month period; provided, however, that if Aphoenix does
not submit the [...***...] Target to Anadys for screening on or before the
thirty-month anniversary of the Effective Date, then Anadys shall have no
obligation to screen the [...***...] Target.
2.2 JOINT RESEARCH COMMITTEE.
(a) FORMATION. The Parties shall establish after the Effective
Date a joint research committee comprised of two (2) members from each Party
("JOINT RESEARCH COMMITTEE" or "JRC"). A Party may designate substitutes for its
JRC members to participate if one or more of such Party's members cannot attend
a meeting. A Party may replace either of its JRC members by giving the other
Party notice stating the member to be replaced and the replacement.
(b) RESPONSIBILITIES. The JRC shall have overall responsibility
for (1) directing and monitoring the work performed under this Agreement, (2)
establishing the criteria for a Validated Hit, (3) reviewing all data and
information generated in the conduct of the Work Plan, (4) reviewing and
approving any proposed modifications to the Work Plan, and (5)
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facilitating a high level of interaction and communication between Aphoenix and
Anadys. The role of the JRC shall be advisory.
(c) MEETING. The JRC shall hold meetings once per calendar quarter
to review in reasonable detail all data and information generated in the conduct
of the Work Plan. Meetings may take place via teleconference or videoconference.
2.3 CONDUCT OF RESEARCH.
(a) During the Term of this Agreement, Aphoenix shall supply to
Anadys the quantities of protein of the Aphoenix Targets set forth in the Work
Plan and the Aphoenix Compounds, as selected by Aphoenix. Anadys shall conduct
biophysical characterization of the Targets and shall use its assay development
and validation capabilities to develop a validated screening assay for use with
ATLAS(TM) for each of the Aphoenix Targets (each, a "TARGET ASSAY") pursuant to
the Work Plan. Anadys shall, from time to time, provide Aphoenix with oral or
written updates as to the progress of the Target Assay development, will
consider in good faith any guidance or comments that Aphoenix provides with
respect to such development, and, for any candidate Target Assay, will provide
Aphoenix with a written report on such assay, including relevant testing and
validation results, sufficient for Aphoenix to evaluate such assay against the
required parameters and specifications and Anadys' description of the assay. The
Parties anticipate that the above development process of a Target Assay shall be
completed no later than [...***...] from the date when Aphoenix provides such
Target to Anadys. Notwithstanding the foregoing, if, in the course of conducting
biophysical characterization of the Target, it becomes apparent, in Anadys'
judgment, that any of the Targets are not suitable for ATLAS(TM), then Anadys
shall so inform Aphoenix promptly and Aphoenix shall designate replacement
target(s) for the Collaboration.
(b) Anadys shall use the Target Assays to conduct screening of the
Aphoenix Library Compounds and the Anadys Library Compounds as designated in the
Work Plan (the "SCREENING").
(c) Anadys shall provide Aphoenix with written updates as to the
progress of the Screening and shall specify all Validated Hits and their
relevant Target Assay results. At the end of the Screening using the Target
Assays, Anadys shall provide Aphoenix with a written screening report including
results of the screening (the "SCREENING REPORT").
(d) RESEARCH REPORTS. During the term of this Agreement, Anadys
shall keep Aphoenix fully informed as to all discoveries and technical
developments (including, without limitation, any inventions) made in the course
of performing activities under the Work Plan. In addition, prior to each meeting
of the JRC, Anadys will prepare and distribute to all members of the JRC (no
later than five (5) business days prior to each such meeting) a reasonably
detailed written updates setting forth information regarding the Work Plan and
progress of performance of the Work Plan (since the last report). The
information contained in the report shall be accurate in the reporting Party's
best scientific judgment. At Aphoenix's request, at any time during the term of
the Screening, Anadys shall provide written reports of any studies performed by
Anadys as part of the Work Plan which Aphoenix may need to support its
regulatory submissions relating to Collaboration Products and shall allow
Aphoenix to use the data
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included in such reports to support such submissions. Nothing herein will
require either Party to disclose information received from a Third Party that
remains subject to bona fide confidentiality obligations to such Third Party.
2.4 STRUCTURAL INFORMATION ON ANADYS LIBRARY VALIDATED HITS. Within
[...***...] following the delivery of each Screening Report, Aphoenix may, at
its discretion, elect to receive structural information on up to [...***...]
([...***...]) Anadys Library Validated Hits from each applicable Target Assay by
providing written notice to Anadys of such election. In the event that Aphoenix
makes any such election, Aphoenix shall owe Anadys the milestone payment(s) as
set forth in Section 6.2 of this Agreement.
3. SHIPMENT OF COMPOUNDS
3.1 SHIPMENT. All deliveries pursuant to this Agreement shall be shipped
to the address and addressee specified by the receiving party and shall be
prepaid by the shipper.
3.2 COSTS. Except for the Research Fee pursuant to Section 6.1, each
Party will bear its own costs and expenses for its activities under the Work
Plan, including without limitation materials, labor, equipment and overhead
costs.
4. ADDITIONAL RESEARCH AND PRECLINICAL AND CLINICAL DEVELOPMENT OF INFECTIOUS
DISEASE TARGET VALIDATED HITS
4.1 INVESTIGATION AND CHARACTERIZATION OF INFECTIOUS DISEASE TARGET
VALIDATED HITS
(a) If Aphoenix wishes to screen an Infectious Disease Target and
screening of such Infectious Disease Target generates Validated Hits, once the
JRC identifies one or more such Infectious Disease Target Validated Hits, Anadys
will, at its sole discretion, have the option to collaborate with Aphoenix to
advance such Infectious Disease Target Validated Hits through lead optimization
and into further development by providing Aphoenix with a Participation Notice
within sixty (60) days from the date that the JRC identifies such Infectious
Disease Target Validated Hit(s).
(b) If Anadys provides Aphoenix with a Participation Notice, then
Aphoenix and Anadys will (i) promptly commence good faith negotiations to agree
on [...***...],[...***...] and [...***...] of [...***...] be [...***...], the
[...***...],[...***...] and [...***...] rights of any [...***...] arising from
the [...***...], and the [...***...] of the [...***...] including, without
limitation, [...***...] rate, [...***...] and [...***...], and (ii) document
such agreed upon terms in a Infectious Disease Collaboration Agreement. The
terms of the Infectious Disease Collaboration Agreement, with respect to such
Infectious Disease Target Validated Hit, will replace and supersede the
applicability of Sections 5, 6.2 and 6.3 of this Agreement as to such Infectious
Disease Target Validated Hit. If Anadys and Aphoenix
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cannot reach agreement on the terms of the Infectious Disease Collaboration
Agreement within [...***...] from the day Anadys provides Aphoenix with the
Participation Notice, the parties shall refer such unagreed terms to the Chief
Executive Officers ("CEOs") of Anadys and Aphoenix to attempt in good faith to
reach a mutually agreeable decision as to such terms. If the CEOs cannot reach
consensus on the matter within [...***...] from the day the matter is so
submitted to them, then on such [...***...], Aphoenix will [...***...], and
[...***...] on the [...***...] of [...***...] or [...***...],[...***...] the
[...***...] of [...***...] in the [...***...]. If [...***...] at [...***...] to
[...***...] or [...***...] to [...***...], then [...***...] shall [...***...]
with [...***...] of its [...***...],[...***...] the [...***...] and [...***...]
of the [...***...] to be [...***...] or [...***...] and the [...***...] or
[...***...] and [...***...] the [...***...] to [...***...]. [...***...] shall
[...***...] from the [...***...] is [...***...] to [...***...] to [...***...]
the [...***...] to the [...***...] in the [...***...] the [...***...] in the
[...***...], or to [...***...] to [...***...] to the [...***...] and to
[...***...] to be [...***...] the [...***...] the [...***...] and [...***...] of
which [...***...] to the [...***...],[...***...] to [...***...]. In the
[...***...] that [...***...] to [...***...],[...***...] shall be [...***...]
([...***...]) following the [...***...] to [...***...]. At no time shall
[...***...] or [...***...] to [...***...] on [...***...] to the [...***...].
(c) If Anadys does not provide Aphoenix with a Participation
Notice as to any given Infectious Disease Target Validated Hit, or if the
Parties fail to reach agreement on the terms of an Infectious Disease
Collaboration Agreement for such Infectious Disease Target Validated Hit then
the provisions of Section 5 and Sections 6.2 and 6.3 of this Agreement shall
apply to such Validated Hit.
5. ADDITIONAL RESEARCH AND PRECLINICAL AND CLINICAL DEVELOPMENT OF VALIDATED
HITS
5.1 INVESTIGATION AND CHARACTERIZATION OF VALIDATED HITS
(a) The provisions of this Section 5 shall apply to (i) any
Validated Hit that is not an Infectious Disease Target Validated Hit, (ii) any
Infectious Disease Target Validated Hit for which Anadys does not provide
Aphoenix with a Participation Notice, and (iii) any Infectious Disease Target
Validated Hit for which the Parties fail to reach agreement on the terms of an
Infectious Disease Collaboration Agreement.
(b) Once the JRC identifies a Validated Hit or once an Infectious
Disease Target Validated Hit becomes subject to this Section 5, Aphoenix, at its
sole discretion and expense, may make (by itself or via any Third Party) all
further evaluation, characterization and optimization of such Validated Hit (the
"Additional Research").
(c) Notwithstanding Section 5.1(b), upon completion of screening
of each Target during the Collaboration and delivery of the final report to
Aphoenix by Anadys and at Aphoenix's discretion, Aphoenix may request that
Anadys provide its capabilities to optimize one or more Validated Hits to Lead
Compounds by performing Additional Research.
(d) Anadys, in its sole discretion, may agree to perform certain
Additional Research as may be requested by Aphoenix pursuant to Section 5.1(c).
If Anadys elects to
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provide any such Additional Research, Aphoenix and Anadys will agree on the
number of FTE's, term and scope of work to be done, the FTE rate, and additional
milestones and royalties, and will [...***...] such agreed upon terms
[...***...].
5.2 DESIGNATION OF LEAD COMPOUNDS. Aphoenix may, in its sole
discretion and acting in good faith, designate as a Lead Compound any Validated
Hit or any derivative of a Validated Hit generated by the introduction of one or
more structural changes into a Validated Hit, in either case (i) that is
identified on the basis of its activity with respect to the Target in either the
Target Assay for activity against or interaction with the Target, and (ii) for
which Aphoenix intends to conduct preclinical or clinical development or
commercialization activities. If Aphoenix designates an Anadys Library Lead
Compound, Aphoenix will promptly so notify Anadys and provide Anadys with a
designation for such Anadys Library Lead Compound for future reporting purposes.
5.3 PRECLINICAL AND CLINICAL DEVELOPMENT. After designating a Lead
Compound, Aphoenix shall have sole and full control, authority, discretion and
right to conduct (by itself or via any Third Party) and make decisions regarding
all clinical development of Collaboration Products worldwide, including the
conduct of any pre-clinical and clinical development of Collaboration Products
(which shall be conducted using standard pharmaceutical industry practices) and
making all regulatory filings necessary to obtain regulatory approvals of
Collaboration Products.
5.4. COMMERCIALIZATION. Aphoenix shall have sole and full control,
authority, discretion and right to conduct (by itself or via any Third Party)
and make decisions regarding all commercialization of Collaboration Products and
may carry out such efforts in its sole discretion.
6. PAYMENTS
6.1 RESEARCH FEE. Aphoenix shall pay to Anadys a non-refundable
research fee of one million two hundred fifty thousand United States Dollars (US
$1,250,000.00) (the "Research Fee") for the work performed under the
Collaboration. The Research Fee shall be paid in installments, of which forty
percent (40%) of the Research Fee will be due and payable to Anadys within
twenty-one (21) calendar days after the Effective Date, thirty percent (30%) of
the Research Fee will be due and payable to Anadys by April 30, 2005, and the
remaining thirty percent (30%) of the Research Fee will be due and payable to
Anadys within twenty-one (21) calendar days of initiation of work on the
[...***...] Target.
6.2 MILESTONE PAYMENTS. If, pursuant to Section 2.4, Aphoenix
elects to receive structural information on up to [...***...] ([...***...])
Anadys Library Validated Hits from each applicable Target Assay, Aphoenix will
pay to Anadys a milestone payment in the amount of [...***...] United States
Dollars (US $[...***...]) for each Target Assay batch (the "MILESTONE PAYMENTS")
within thirty (30) days after the achievement of such milestone, as measured by
the date the compound information from such Target Assay is delivered to
Aphoenix.
6.3 ROYALTIES AND ADDITIONAL MILESTONES. In addition to the
Milestone Payments that may become payable to Anadys pursuant to Section 6.2,
Aphoenix will pay to Anadys
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[...***...] percent ([...***...]%) of any and all up-front fees, milestone
payments and royalties that are either (i) received by Aphoenix or any Affiliate
of Aphoenix as a result of [...***...] Anadys Library Validated Hit or
derivative thereof, any Anadys Library Lead Compound or any Collaboration
Product that is a pharmaceutical composition of an Anadys Library Lead Compound,
(ii) received by any Third Party [...***...] Aphoenix or an Affiliate of
Aphoenix has granted to such Third Party [...***...] any Anadys Library
Validated Hit or derivative thereof, any Anadys Library Lead Compound or any
Collaboration Product that is a pharmaceutical composition of an Anadys Library
Lead Compound. For clarity, Aphoenix will [...***...] any [...***...] for any
[...***...] or [...***...] thereof, [...***...], or any [...***...] that is a
[...***...] of an [...***...]; provided, however, that Section 6.2 and this
Section 6.3 shall have no applicability to any Infectious Disease Target
Validated Hit that is the subject of an Infectious Disease Collaboration
Agreement.
7. OWNERSHIP OF INVENTIONS; LICENSES
7.1 INVENTIONS. The ownership of inventions conceived of and reduced to
practice as part of the activities under this Agreement that relate to any
improvements to ATLAS(TM) or Assay Technology shall belong to Anadys.
7.2. RESEARCH LICENSES. Each Party hereby grants to the other Party a
nonexclusive, paid up license under all Patents and all other intellectual
property rights controlled by the granting Party solely for purpose of
performance by the other Party of its responsibilities under the Work Plan in
accordance with this Agreement, which licenses shall terminate automatically at
the end of the Collaboration.
7.3 RESEARCH RESULTS LICENSE. Aphoenix hereby grants to Anadys a
non-exclusive, perpetual, irrevocable, paid up, worldwide license to use the
Research Results only for (i) describing generally to Third Parties results
obtained with ATLAS(TM), without specific mention of the Target or Aphoenix, or
the chemical structure thereof, or of information that could reasonably permit a
Third Party to deduce such information, and (ii) compiling information and data
about the general conduct, performance, characteristics and results of ATLAS(TM)
screens without regard to the Target, provided that such information is blinded
with respect to the Target and Aphoenix.
7.4. NO IMPLIED LICENSES. Nothing in this Agreement shall be deemed to
grant either Party any license or other rights to practice any intellectual
property rights of the other Party or such other Party's Confidential
Information, other information or other rights except as expressly stated in
this Section 7, including that nothing in this Agreement is intended to, or
shall, give Aphoenix any license or other right to practice ATLAS(TM).
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8. CONFIDENTIAL INFORMATION.
8.1 NON-DISCLOSURE OBLIGATION. During the term of this Agreement and for
[...***...] ([...***...]) years following its expiration or termination, any and
all knowledge, know-how, assay information, compound structures, practices,
processes or other information received by one party to this Agreement (the
"RECEIVING PARTY") from the other party to this Agreement (the "DISCLOSING
PARTY") pursuant to this Agreement (hereinafter referred to as "CONFIDENTIAL
INFORMATION") shall be received and maintained by the Receiving Party in strict
confidence, shall not be disclosed to any third party, and shall not be used by
the Receiving Party for any purpose other than those purposes specified in this
Agreement, unless the Receiving Party can demonstrate by competent written proof
that such Confidential Information. For clarity, Aphoenix may use and disclose,
with its sole discretion and without any restraint, any information with regard
to Aphoenix Library Lead Compound and other the Target Assay results from
Aphoenix Library compound.
(a) was already known to the Receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the Disclosing
Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving Party;
(c) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act of
omission of the Receiving Party in breach of this Agreement;
(d) was disclosed to the Receiving Party, other than under an
obligation of confidentiality to a third party, by a third party who had no
obligation to the Disclosing Party not to disclose such information to others;
or
(e) was independently discovered or developed by the Receiving
Party without the use of Confidential Information belonging to the Disclosing
Party.
8.2 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 Inventions;
(b) prosecuting or defending litigation;
(c) complying with applicable governmental regulations; and
(d) disclosure to Affiliates, sublicensees, employees, consultants
or agents each of whom is bound by similar terms of confidentiality and non-use
at least equivalent in scope to those set forth in this Section 8; and
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(e) disclosure to investment bankers.
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 8.2, it will, except where impracticable, give reasonable advance notice
to the other Party of such disclosure and use best efforts to take all
reasonable action to avoid disclosure of Confidential Information hereunder. The
parties agree that the press release attached hereto is an authorized
disclosure.
8.3 COVENANT NOT TO REVERSE ENGINEER. Anadys shall not attempt to ascertain,
by any means, the chemical structure or any other information concerning any
compound supplied by Aphoenix hereunder. Anadys shall not use the quantities of
protein of the Aphoenix Targets or the Aphoenix Compounds or the Research
Results for any purpose other than the conduct of the Work Plan in accordance
with this Agreement; provided, however, that Anadys may use the statistic data
of the number of hits obtained for internal research purposes and may disclose
to third parties without reference to the Research Results, the statistic of the
number of hits obtained and the fact that the Aphoenix Targets are in a defined
therapeutic area, without disclosing any other information, including, without
limitation, the identity of the Aphoenix Targets.
9. REPRESENTATIONS AND WARRANTIES
9.1 BY ANADYS. Anadys represents and warrants to Aphoenix the
followings;
(a) it has the right to carry out the activities under Section 2
above
(b) it has not previously entered and will not enter during the
term of this Agreement into any agreement with a third party in
conflict with this Agreement.
(c) [...***...],[...***...] or [...***...] and [...***...] with
the [...***...] or under [...***...] or [...***...] of the
[...***...]
[...***...]
9.2 BY APHOENIX. Aphoenix represents and warrants to Anadys that it has
the right to provide the protein of the Aphoenix Targets and Aphoenix Compounds
to be supplied hereunder to Anadys.
10. TERM; TERMINATION
10.1 TERM. This Agreement shall become effective as of the Effective Date
and unless earlier terminated in accordance with this Section 10, shall expire
ninety (90) days after submission of the final Screening Report.
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11.
10.2 TERMINATION FOR BREACH. In the event that either party to this
Agreement shall be in default of any of its material obligations hereunder and
shall fail to remedy such default within thirty (30) days after receipt of
written notice thereof, the party not in default shall have the option of
terminating this Agreement by giving written notice thereof, notwithstanding
anything to the contrary contained in this Agreement.
10.3 ACCRUED RIGHTS; SURVIVING OBLIGATIONS. Termination of this Agreement
shall not affect any accrued rights of either Party. The terms of Sections
[...***...] and [...***...] of this Agreement shall survive termination of this
Agreement, provided, however, that only [...***...] shall survive termination of
this Agreement caused pursuant to Section [...***...]. Promptly after
termination of this Agreement Anadys shall return or dispose of any materials
and information of Aphoenix in accordance with the instructions of Aphoenix,
including without limitation any protein of the Aphoenix Targets and the
Aphoenix Compounds provided by Aphoenix hereunder and written materials
disclosed by Aphoenix hereunder.
11. GOVERNING LAW; DISPUTE RESOLUTION
11.1 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of California without giving effect to any choice or
conflict of law provision or rule that would cause the application of the laws
of any jurisdiction other than California.
11.2 DISPUTE RESOLUTION. In the event of any controversy or claim arising
out of, relating to or in connection with any provision of this Agreement, the
parties shall try to settle their differences amicably and in good faith between
themselves first, by referring the disputed matter to the respective heads of
research of each Party and, if not resolved by the research heads, then the
research heads shall refer the disputed matter to the respective CEOs of each
Party and, if not resolved by the CEOs, then either party may refer the matter
to be settled by binding arbitration. The arbitration shall be held in
[...***...] in accordance with the arbitration rules of the [...***...], or
[...***...].
12. MISCELLANEOUS
12.1 NOTICES. All notices required or permitted to be given under this
Agreement shall be in writing and shall be mailed by registered or certified
airmail, postage prepaid, addressed to the signatory to whom such notice is
required or permitted to be given or 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 transmitted by facsimile.
All notices to Aphoenix shall be addressed as follows:
APHOENIX, INC.
Toushi Ikusei Xxxx. 0-00-00,
Xxxxxxx, Xxxxxxx-xx,
Xxxxx 000-000, Xxxxx
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12.
Attention: Xxxxxx Xxxx, CEO
Fax: [...***...]
All notices to Anadys shall be addressed as follows:
Anadys Pharmaceuticals, Inc.
0000 Xxxxxxxxxx Xxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxx Xxxxxx, Xx. Vice President,
Corporate Development & Finance
Fax: ([...***...])[...***...]
with a copy to:
Anadys Pharmaceuticals, Inc.
0000 Xxxxxxxxxx Xxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxxxx X. Xxxx, Senior Director,
Legal Affairs
Fax: ([...***...])[...***...]
Any Party may, by written notice to the other, designate a new addressee,
address or facsimile number to which notices to the Party giving the notice
shall thereafter be mailed or faxed.
12.2 INDEPENDENT CONTRACTORS. The Parties shall perform their obligations
under this Agreement as independent contractors and nothing contained in this
Agreement shall be construed to be inconsistent with such relationship status.
This Agreement shall not constitute, create or in any way be interpreted as a
joint venture or partnership of any kind.
12.3 ENTIRE AGREEMENT; AMENDMENT. This Agreement sets forth all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto and supersedes and terminates all
prior agreements and understandings between the Parties hereto with regard to
the subject matter hereof, and there are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties hereto other than as set forth herein. No
subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties hereto unless reduced to writing and signed by the
respective authorized officers of the Parties hereto.
12.4 AFFILIATES; ASSIGNMENT. Except as otherwise provided in this Section
12.4, neither Party may assign its rights or obligations under this Agreement
without the prior written consent of the other Party, such consent not to be
unreasonably withheld, except that a Party may assign its rights or obligations
to a third party in connection with the merger, consolidation, reorganization or
acquisition of stock or assets affecting substantially all of the assets or
actual voting control of the assigning Party. 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 12.4 shall be of no
force or effect.
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12.5 HEADINGS. The headings used in this Agreement are for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
12.6 FORCE MAJEURE. Any delays in performance by any Party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the reasonable control of the Party
affected, including but not limited to, acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion or sabotage. The Party
suffering such occurrence shall immediately notify the other Party and any time
for performance hereunder shall be extended by the actual time of delay caused
by the occurrence.
12.7 SEVERABILITY. If any term, condition or provision of this Agreement
is held to be unenforceable for any reason, it shall, if possible, be
interpreted rather than voided, in order to achieve the intent of the Parties to
this Agreement to the extent possible. In any event, all other terms, conditions
and provisions of this agreement shall be deemed valid and enforceable to the
full extent.
12.8 WAIVER. None of the terms, covenants, and conditions of this
Agreement can be waived except by the written consent of the Party waiving
compliance.
12.9 ENGLISH LANGUAGE. This Agreement has been prepared in the English
language and shall be construed in the English language.
12.10 COUNTERPARTS. This 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.
[SIGNATURE PAGE FOLLOWS]
14.
IN WITNESS WHEREOF, the parties have by duly authorized persons, executed
this Agreement, as of the date first above written.
APHOENIX, INC. ANADYS PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxx By: /s/ Xxxxxxx X. Xxxxxx
------------------------------------ ------------------------------------
Name: Xxxxxx Xxxx Name: Xxxxxxx X. Xxxxxx
Title: Chief Executive Officer Title: Senior Vice President,
Corporate Development & Finance
15.
EXHIBIT A
WORK PLAN
PROPOSED ATLAS WORK PLAN FOR APHOENIX TARGET
OBJECTIVE
To discover small molecule lead compounds for [...***...] ([...***...]) Aphoenix
targets through high throughput screening of Aphoenix and Anadys compound
libraries [...***...] ([...***...] Aphoenix and [...***...] Anadys compounds)
for each target
MATERIALS
Aphoenix will provide Anadys the target protein for protein characterization,
assay development, and compound screening (Anadys has full capability and
capacity for protein expression and purification which is accessible to
partners)
Aphoenix will provide Anadys [...***...] compounds
PROPOSED WORK PLAN
1. CHARACTERIZATION OF TARGET PROTEIN
- CD (circular dichroism) scan to assess protein folding
- CD-melting profiles to assess protein thermal denaturation
- Effect of buffers, pH, salt, additives
- Effect of known ligands (if available)
- [...***...]
- Effect of known ligands (if available)
- SUCCESS CRITERIA
- Protein is folded at room temperature (by CD)
- Protein undergoes thermal denaturation with a biphasic profile
and defined Tm
- [...***...]
- Known ligands protect thermal denaturation by CD and
[...***...] (if known ligands are available)
2. ASSAY DEVELOPMENT AND OPTIMIZATION
- ATLAS profiles at various protein concentration to assess the
feasibility of the target for ATLAS
- Optimization of conditions for [...***...]
- [...***...]
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- Selection of T-ATLAS for screening assay
- Effect of ATLAS [...***...] by known ligands (if available)
- SUCCESS CRITERIA
- ATLAS signal has a >[...***...]-fold window at T-ATLAS
- [...***...]
- [...***...]
- Known ligands shift ATLAS profiles (if known ligands are
available)
3. ASSAY VALIDATION
- Validation of the ATLAS assay on the robotic system
- Screening of [...***...] DMSO plates to assess inner- and inter-plate
variations and Z' values
- SUCCESS CRITERIA
- The [...***...]-fold signal window at T-ATLAS is maintained on
the robotic system
- Z' values are [...***...] or higher
4. COMPOUND FORMATTING AND ASSAY PLATE PREPARATION
- Final screening conc. = [...***...] uM (or as recommended by Aphoenix)
- May require intermediate dilution of high concentration stocks
5. PILOT SCREEN
- Screening of [...***...] compounds [...***...] from Aphoenix or Anadys
libraries the robotic system to asseSS reproducibility
- SUCCESS CRITERIA
- Z' values for pilot screen are [...***...] or higher
- [...***...] of [...***...] screening results
6. COMPOUND SCREENING
- Screening of [...***...] Aphoenix library compounds and [...***...]
Anadys library compounds ([...***...])
- SUCCESS CRITERIA
- Spiked known ligands are picked up as hits (if known ligands are
available)
- Assay performance acceptable (Z' values > [...***...])
7. HIT CONFIRMATION AND FOLLOW UP
- Retest the hits [...***...] screening concentration
- Generate dose-response curves for confirmed hits
8. GENERATION OF A DETAILED FINAL REPORT CONTAINING ALL THE RESULTS
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17.
