Exhibit 10.2
COLLABORATION AND LICENSE AGREEMENT
This Agreement
(“Agreement”) dated December 12, 2003, and
effective as of January 5, 2004 (the “Effective
Date”), is by and between Avalon Pharmaceuticals, Inc., a
Delaware Corporation, located at 20358 Seneca Meadows Parkway,
Germantown, Maryland 20876 (“Avalon”), and Aventis
Pharmaceuticals Inc., a Delaware corporation with a place of
business at 200 Crossing Boulevard, Bridgewater, New Jersey 08807
(“Aventis”).
WHEREAS, Avalon
has technology with respect to identifying potential pharmaceutical
targets to be used for discovering, researching and developing
pharmaceutical products; and
WHEREAS, Aventis
desires to collaborate with Avalon and provide funding to Avalon
with respect to the identification, discovery and validation of
druggable screening targets using Avalon’s proprietary
molecular cytogenetics platform and Avalon’s and
Aventis’ genomics, oncology and target validation
capabilities, all pursuant to the terms and provisions of this
Agreement.
NOW, THEREFORE, in
consideration of the mutual promises and other good and valuable
consideration, the Parties agree as follows:
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
ARTICLE 1
DEFINITIONS
The
terms used in thus Agreement have the following
meanings:
1.1
“Advanced SQT” means an SQT that Aventis has determined
has satisfied the criteria set forth on
Schedule 1.1.
1.2
“Affiliate”, with respect to any Party, means any
Person whether de jure or de facto, controlling, controlled by, or
under common control with, such Party. For these purposes,
“control” shall be presumed to exist if one of the
following conditions is net: (a) direct or indirect ownership
of more than fifty percent (50%) of the stock or shares having the
right to vote for the election of directors, and (b) in the
case of non-corporate entities, direct or indirect ownership of
more than fifty percent (50%) of the equity interest with the power
to direct the management and policies of such non-corporate
entities or status as the general partner in the case of any
partnership. The Parties acknowledge that in the case of certain
entities organized under the laws of certain countries outside of
the United States, the maximum percentage ownership permitted by
law for a foreign investor may be fifty percent (50%) or less, and
that in such case such lower percentage shall be substituted in the
preceding sentence, provided that such owner has the power to
direct the management and policies of such entity.
1.3
“Amplicon” means a specific region of chromosomal DNA
that is amplified in a cancer sample, as determined by comparative
genomics hybridization.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
2
1.4
“Avalon Know-How” means information, trade secrets,
know-how, inventions, and data that (a) is Controlled by
Avalon and exists as of the Effective Date, or (b) is created
solely by Avalon in Avalon’s performance of Research under an
Research Plan during the Research Term and that, in each of the
foregoing cases, relates to or is useful with respect to a DRG or
use thereof in Screening. For the avoidance of doubt, Avalon
Know-How does not include information, trade secrets, know-how,
inventions and data that is directed to discovering or identifying
Targets.
1.5
“Avalon Patent(s)” means any and all Patent Rights in
the Territory that claim a DRG or the manufacture of a DRG or use
of a DRG in Screening, or use of a DRG in the Field, which Patent
Rights are Controlled by Avalon. For the avoidance of doubt, Avalon
Patents do not include Patent Rights to the extent that they claim
methods or products for discovering or identifying
Targets.
1.6
“Avalon Technology” means, individually and
collectively, Avalon Patent(s) and Avalon Know-How.
1.7
“Avalon Validation Activities” means the activities set
forth on Schedule 1.7.
1.8
“Aventis Target Technology” has the meaning set forth
in Section 3.6(e).
1.9
“Breaching Party” has the meaning set forth in
Section 10.2(a).
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
3
1.10 “Change
of Control” means (a) a merger or consolidation of
Avalon and any Third Party which results in the voting securities
of Avalon outstanding immediately prior thereto ceasing to
represent more than fifty percent (50%) of the combined voting
power of the surviving entity immediately after such merger or
consolidation, or (b) any Third Party, together with its
affiliates, becoming the beneficial owner of fifty percent (50%) or
more of the combined voting power of the outstanding securities of
Avalon, or (c) the sale or other transfer to a Third Party of
all or substantially all of Avalon’s assets which relate to
this Agreement.
1.11
“Collaboration Product” means a compound(s) or
molecule, (i) the pharmacological affinity or activity of
which, or the utility of which as a pharmaceutical agent, is
because such compound or molecule affects the activity, inactivity
or function of an Advanced SQT.
1.12
“Commercialization” or “Commercialize”
means activities directed to obtaining pricing and reimbursement
approvals, manufacturing, marketing, promoting, detailing,
distributing, importing or selling a Collaboration
Product.
1.13
“Commercially Reasonable Efforts” means * .
1.14
“Confidential Information” means all proprietary
materials, know-how or other information (whether or not
patentable) regarding a Party’s technology, products,
business information or objectives, which is designated as
confidential in writing by the disclosing Party, whether by letter
or by the use of an appropriate stamp or legend, prior to or at the
time any such material, know-how or other information is disclosed
by the disclosing Party to the
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
4
other Party. Notwithstanding the
foregoing to the contrary, materials, know-how or other information
which is orally, electronically or visually disclosed by a Party,
or is disclosed in writing without an appropriate letter, stamp or
legend, shall constitute Confidential Information of a Party
(a) if the disclosing Party, within thirty (30) days
after such disclosure, delivers to the other Party a written
document or documents describing the materials, know-how or other
information and referencing the place and date of such oral,
visual, electronic or written disclosure and the names of the
persons to whom such disclosure was made, or (b) such
information is of the type that is customarily considered to be
confidential information by persons engaged in activities that are
substantially similar to the activities being engaged in by the
Parties. Notwithstanding the foregoing, (x) any technical or
financial information of a Party disclosed at a meeting of the
Research Committee (or any subcommittees or project teams of the
foregoing) or disclosed through an audit report shall constitute
Confidential Information of such Party and (y) the terms of this
Agreement to the extent not disclosed in a public filing shall
constitute Confidential Information of each Party unless otherwise
specified. Confidential Information shall not include any such
information that the Receiving Party can demonstrate:
(a) was known to
the Receiving Party at the time of disclosure by the Disclosing
Party (other than through receipt from the Disclosing Party or its
Affiliates), as can be established by written documentation;
or
(b) was generally
available to the public or was otherwise part of the public domain
at the time of such disclosure or became generally available to the
public or
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
5
otherwise part of the public domain after such
disclosure other than through any act or omission of the Deceiving
Party in breach of this Agreement; or
(c) became known
to the Receiving Party after disclosure by the Disclosing Party
through a non-confidential disclosure from a source that, to the
reasonable knowledge of the Receiving Person, was not under an
obligation of confidentiality to the Disclosing Party.
1.15
“Control” or “Controlled” means the
possession (whether by ownership or license, other than the
licenses granted herein) by a Party of the ability to grant
licenses or sublicenses as provided herein thereto without
breaching an agreement with a Third Party.
1.16
“Cytogenetics” means the study of chromosomal gene
amplifications and/or rearrangement in the field of
oncology.
1.17
“Develop” or “Development” means
preclinical and clinical drug and/or biological development
activities, including (a) test method development and
stability testing, toxicology, formulation, quality
assurance/quality control development, statistical analysis,
clinical studies and regulatory affairs, approval and registration,
in each case, of a Collaboration Product, (b) Screening against
Advanced SQTs, and (c) optimization of Collaboration Products
for the purpose of initiating pre-clinical and clinical work with
respect to Collaboration Products for Advanced SQTs.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
6
1.18
“Disclosing Party” means a Party that discloses its
Confidential Information to the other Party.
1.19
“DRG” means a Target that has been accepted by the
Research Committee for inclusion in the Research Program. For the
avoidance of doubt, each SQT and each Advanced SQT is a DRG and no
Excluded Target is a DRG.
1.20 “Early
Development Candidate” means a Collaboration Product that
meets the “EDC” criteria contained in
Schedule 1.20.
1.21
“Excluded Target” has the meaning set forth in
Section 3.5(a).
1.22
“Field” means the treatment and/or prevention of
disease in humans and diagnostics where such diagnostic is useful
in the promotion of a Collaboration Product.
1.23
“FDA” means the United States Food and Drug
Administration, or the successor thereto or an equivalent
organization in Europe or Japan.
1.24
“FTE” means a full time equivalent person year
consisting of * of technical or scientific work on or directly
related to Research by persons who qualify as Avalon
Researchers.
1.25 “First
Commercial Sale” means on a country-by-country and
Collaboration Product-by-Collaboration Product basis, the first
sale by Aventis or its Affiliate or their Sublicensee, distributor
or co-marketer of Collaboration Product to a Third Party in a
country after Regulatory Approval has been obtained from the
appropriate regulatory agency(ies).
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
7
Sales for test marketing,
sampling and promotional uses, clinical trial purposes or
compassionate or similar use shall not be considered to constitute
a First Commercial Sale.
1.26 “Gene
Set” means two or more genes, or any portion thereof (e.g.,
oligonucleotides) that are used in the analysis of the effect of
any treatment on the gene expression pattern in a test cell, tissue
or organism.
1.27
“IND” means an Investigational New Drug application
filed with the FDA to obtain approval to conduct human clinical
trials of the Product for an indication.
1.28
“Indemnitee” has the meaning set forth in
Section 8.3(a).
1.29
“Indemnitor” has the meaning set forth in
Section 8.3(a).
1.30
“Infringing DRG” has the meaning set forth in
Section 7.2(a).
1.31 “Joint
Rights” has the meaning ascribed thereto in
Section 7.5(a)(iii).
1.32
“NDA” means a New Drug application or equivalent
thereof that is fled at the FDA.
1.33
“Party” means Avalon or Aventis and, when used in the
plural, shall mean Avalon and Aventis.
1.34 “Patent
Rights” means all existing patents and patent applications
and all patent applications hereafter fled, including any
continuations, continuations-in-part, divisions, provisionals or
any substitute applications, any patent issued with respect to any
such patent
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
8
applications, any reissue,
reexamination, renewal or extension (including any supplemental
patent certificate) of any such patent, and any confirmation patent
or registration patent or patent of addition based on any such
patent, and all foreign counterparts of any of the
foregoing.
1.35
“Person” means any natural person, corporation, firm,
business trust, joint venture, association, organization, company,
partnership or other business entity, or any government or any
agency or political subdivision thereof.
1.36 “Phase
I Clinical Trial” means a study or trial as defined in
Federal Regulation 21 C.F.R. 312.21 or successor thereto or if
conducted outside the United States corresponding laws outside the
United States.
1.37 “Phase
IIB Clinical Trial” means, as to a Collaboration Product for
a particular indication, a controlled and lawful dose ranging
clinical trial conducted inside and/or outside the United States in
humans to evaluate further the efficacy and safety of a candidate
drug in a targeted patient population and to define the optimal
dosing regimen.
1.38 “Phase
III Study” means, as to a Collaboration Product for a
particular indication, a controlled and lawful study conducted
inside and/or outside the United States in humans of the safety and
efficacy of such product for such indication, which is
prospectively designed to demonstrate statistically whether such
product is safe and effective for use in such indication in a
manner sufficient to file an NDA to obtain regulatory approval to
market and sell that product for the indication under investigation
in such study.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
9
1.39
“Receiving Party” means a Party that receives
Confidential Information from a Disclosing Party, including, but
not limited to, employees, directors and officers of the Receiving
Party.
1.40
“Regulatory Approval” means any and all approvals
(including any applicable governmental price and reimbursement
approvals), licenses, registrations, or authorizations of any
federal, national, multinational, state, provincial or local
regulatory agency, department, bureau or other governmental entity
necessary for the manufacture, use, storage, import, transport,
promotion, marketing and sale of a product in a country or group of
countries.
1.41
“Research” (a) in the case of Avalon, means *
.
1.42
“Research Committee” means the committee established in
Section 3.1.
1.43
“Research Plan” means the plan and budget attached as
Schedule l .43.
1.44
“Research Program” means the collaborative research
program to be conducted by the Parties in accordance with the
Research Plan.
1.45
“Research Term” has the meaning set forth in
Section 3.2(b).
1.46
“Reversion Product” means a compound or molecule that
is identified by Avalon or its licensee (other than Aventis) by
Screening against a Reversion Target. In no event shall a Reversion
Product include any compound, molecule or antibody Controlled by
Aventis.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
10
1.47
“Reversion Target” means a DRG that reverts to Avalon
under Section 3.6(c). For clarity, “Reversion
Target” shall not include any Excluded Target nor any Aventis
Target.
1.48
“Screen” means use of a Target to determine the effect
of one or more compounds or molecules on the activity, inactivity
or function of the Target. It is expressly understood that a Screen
does not include the use of a DRG as part of a Gene Set.
1.49
“SQT” means a DRG that has been selected by Aventis
pursuant to Section 3.5 (b).
1.50
“Sublicensee” means a Third Party to which Aventis has
granted sublicense rights under the licenses granted to Aventis
hereunder or to which Aventis has granted rights to a Collaboration
Product.
1.51
“Target” means a protein whose function, activity or
inactivity is associated with cancer in humans and the gene that
encodes such protein and that is identified by Research under the
Research Plan during the Research Term or that was identified prior
to the Effective Date by the use of Cytogenetics.
1.52
“Term” means the period beginning on the Effective Date
and ending on the earlier of the date on which this Agreement
expires under Section 10.1 or the date upon which this
Agreement otherwise terminates.
1.53
“Territory” means all countries of the
world.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
11
1.54 “Third
Party” means any Person who or which is neither a Party nor,
with respect to a Party, an Affiliate of that Party.
1.55 “Third
Party Claim” has the meaning set forth in
Section 8.3(a).
ARTICLE 2
GRANT OF LICENSES AND EXCLUSIVITY
2.1
Licenses.
(a) Except as
provided in Section 2.4(c), Avalon grants to Aventis an
exclusive license (even as to Avalon and its Affiliates) in the
Territory under Avalon Technology to make, have made and use each
DRG that is not a Reversion Target in a Screen for Research and for
the Development of one or more Collaboration Products in the
Field.
(b) Except as
provided in Section 2.4(c), Avalon grants to Aventis an
exclusive license (even as to Avalon and its Affiliates) in the
Territory under Avalon Technology to make, have made and use each
DRG that is not a Reversion Target, in each case only for
Commercialization of one or more Collaboration Products in the
Field.
(c) Aventis agrees
that it will use Avalon Technology only as licensed under this
Agreement in accordance with the terns and conditions of this
Agreement and, in the case of the license granted in
Section 2.1 (a) and (b), only for so long as
licensed
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
12
under
this Agreement. For the avoidance of doubt, Aventis shall not
obtain any rights or licenses under this Agreement to use any
Reversion Targets,
(d) It is
expressly understood and agreed that the only licenses granted
under this Agreement are the licenses expressly granted under this
Agreement and that there is no implied license or license by
estoppel.
2.2
Sublicensing by Aventis. Aventis shall have the right to grant
sublicenses to Third Parties under the license granted pursuant to
Section 2.1 provided that Aventis shall be responsible for
(i) the making of all payments due, and the making of reports
under this Agreement, with respect to milestones achieved and sales
of Collaboration Product by its Sublicensees and (ii) their
compliance with all applicable licensing terms of this Agreement to
the extent that they are applicable to a Sublicensee.
2.3
Use of Affiliates. The licenses granted pursuant to
Section 2.1 include the right of Aventis to use its Affiliates
in exercising such rights and carrying out its obligations under
this Agreement.
2.4
Exclusivity.
(a) During the
Term, except as provided in Section 2.4(b), neither Avalon nor
its Affiliates may, directly or indirectly, either alone or with a
Third Party, conduct any research, development, manufacturing or
commercialization activity directed at any DRG, SQT or Advanced
SQT, except (i) in the performance of Research under
this
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
13
Agreement and (ii) in exercising
Avalon’s rights to Reversion Targets and Reversion
Products.
(b) During the
Term, neither Aventis nor its Affiliates may, in the field of * ,
directly or indirectly, alone or with a Third Party, (i) * ; or
(ii) * . For the avoidance of doubt, all licenses granted to
Aventis herein with respect to a Reversion Target terminate at the
time the target reverts in accordance with Section 3.6, and
all related Avalon Know-How shall be considered Confidential
Information of Avalon pursuant to Article 9.
(c)
Notwithstanding anything else to the contrary, it is expressly
understood that Avalon and its Affiliates and their collaborators
and licensees shall have the right to include a gene (or a portion
thereof) that is a DRG, SQT or Advanced SQT in a Gene Set for the
purpose of (i) identifying compounds and molecules that affect
expression and/or transcription of such genes and/or
(ii) identifying characteristics and/or properties of a
compound or molecule.
ARTICLE 3
RESEARCH
3.1
Research Committee. Within * after the Effective Date, the Parties
shall form a Research Committee. The Research Committee shall
consist of representatives of each Party and shall be responsible
for overall supervision of Research. Each Party shall be
responsible for its own expenses incurred in connection with
attendance by its personnel at any meeting of
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
14
the Research Committee. The
operation and authority of the Research Committee shall be as
follows:
(a) Supervision.
The Research Committee shall have general supervision over the
strategic direction and management of Research under the Research
Plan. The Research Committee shall periodically review each such
plan from a strategic perspective and propose changes as it deems
necessary to accomplish the Research.
(b)
Representation. Avalon and Aventis shall each appoint at least one
(1) representative as their representative to serve on the Research
Committee and each Party may designate additional or remove
existing representative from time to time. The representative of a
Party may be changed from time to time at the discretion of that
Party upon written notification by the Party making such change to
the other.
(c) Meetings. The
Research Committee shall meet from time to time as determined by
the Research Committee members. It is expected that the Research
Committee shall meet at least * . The location of Research
Committee meetings shall alternate between the offices of each of
the Parties, unless otherwise agreed by the Parties. Minutes of all
meetings setting forth decisions of the Research Committee will be
prepared and circulated by the Party hosting the meeting within *
of such meeting. Such minutes will become official when agreed to
by all members of the Research Committee. If the Research Committee
members all agree, a meeting may be held by means of telephone
conference or similar communications equipment by means
of
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
15
which
all persons participating in the meeting can hear each other. A
quorum for a meeting shall require at least one representative of
Avalon and one representative of Aventis. At each meeting, Aventis
and Avalon will provide a report on the status of Research and
Development at each Research Committee meeting.
(d) Decisions.
Decisions of the Research Committee shall be made at meetings by
unanimous vote, with the representatives of each Party having one
collective vote. If the Research Committee is unable to reach a
unanimous vote on any issue within * after it has been submitted to
a vote, Aventis shall have the right to cast the deciding
vote.
3.2
Research Program.
(a) Objectives.
The intent of the Parties with respect to Research under this
Agreement is as follows:
(i) To discover
and validate a minimum of * Advanced SQTs.
(ii) Avalon will
perform Research in accordance with the Research Plan to identify
Targets which will be presented to the Research Committee and will
perform Avalon Validation Activities. Avalon and Aventis will
perform Research to determine the suitability of DRGs for drug
discovery.
(iii) Aventis will
be responsible for establishing a Screen for an Advanced SQT and
for use of the Screen.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
16
(iv) Aventis will
be responsible for Developing Collaboration Product.
(b) Term. The term
of the Research Program (the “Research Term”) shall
commence on execution of the Agreement and end one calendar year
later, unless (a) earlier terminated pursuant to the
provisions of Article 10 or (b) extended by mutual
agreement of both Parties.
3.3
Research Funding
(a) Subject to
Section 3.3(e), Avalon shall use Commercially Reasonable
Efforts to perform its Research obligations under the Research
Program in accordance with the Research Plan. Subject to
Section 3.3(e), as part of such efforts, during the Research
Term, Avalon shall commit the personnel and facilities necessary to
carry out its obligations under the Research Plan.
(b) AVENTIS shall
pay to AVALON * as support for the Research, pursuant to the
following schedule, which amounts shall be non-refundable and
non-creditable, and due and payable within * after the following
events: (i) * upon the * of the execution of this Agreement; (ii) *
upon the * of the execution of this Agreement; (iii) * upon the *
of the execution of this Agreement; and (iv) * upon the * of the
execution of this Agreement.
(c) Each Party
shall have caused or shall cause each participant in the Research
Program to execute such Party’s standard non-disclosure and
invention assignment agreement.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
17
(d) Each Party
shall identify one of its representatives to serve as a program
coordinator with responsibility for overseeing that Party’s
day-to-day activities relating to the Research Program and to serve
as a contact person for coordinating Research Program activities
between the Parties.
(e) Avalon shall
not be required: (i) to perform any research activities other
than Research, (ii) to provide more than * , (iii) to
perform Research other than under the Research Plan and as funded
by Aventis under this Agreement, or (ii) to perform any
activities which the parties mutually agree that a Third Party will
perform on behalf of Avalon, and which shall be paid for by Aventis
in addition to the funding provided under Section 3.3(b)
above.
(f) Aventis
understands and agrees that Avalon shall not be liable to Aventis
for failing to discover and validate * Advanced SATs or to provide
a specified number of SATs.
3.4
Amplicons, DRGs and Know-How. During the Research Term, Avalon
shall present to the Research Committee for inclusion in the
Research Program an initial group of * in its Control which Avalon
reasonably determines, based on its scientific knowledge at such
time and the criteria provided in the Research Plan, are reasonably
likely to have utility in the Research Program. Avalon and Aventis
shall conduct the Research Program according to the Research Plan.
Aventis shall select Amplicons for inclusion in the Research
Program, designate DRGs for validation as SQTs and designate
SQT’s for validation as Advanced SQTs
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
18
according to the terms of the
Research Plan. In no event shall Avalon have any obligation to
provide * for consideration by Aventis. Avalon shall also provide
Aventis with Avalon Know-How that is currently in the possession of
Avalon and that comes into the possession of Avalon during the
Research Term.
3.5
Inclusion of Targets as DRGs; Excluded Targets, SQTs and Advanced
SQTs.
(a) When Avalon
presents a Target to the Research Committee for inclusion in the
Research Program as a DRG, it shall do so in writing and Avalon
shall present to the Research Committee in writing all information
and material of which Avalon is aware or which is Controlled by
Avalon relating to the potential utility of the Target for
Screening in the Research Program. Within * from the date a Target
is presented to the Research Committee, Aventis shall provide
written notice to the Research Committee if such Target is then the
subject of an Aventis internal program as an SQT in the field of
oncology or is subject to an agreement between Aventis and a Third
Party. If such Target meets such requirements of the preceding
sentence and such notice is provided within such * period, then
such Target shall be deemed an Excluded Target” and shall not
be included in the Research Program and shall not become a
DRG.
(b) By written
notice from Aventis to Avalon, Aventis shall have the right to
designate any DRG that has not become a Reversion Target as a SQT,
and to designate any SQT that has not become a reversion Target as
an Advanced SQT.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
19
3.6
Diligence.
(a) During the
Research Term, Aventis shall use * to perform its Research
obligations in accordance with the Research Plan. During the Term,
Aventis agrees to use * to Develop and Commercialize Collaboration
Products.
(b) The Parties
agree that any Target presented by Avalon to the Research Committee
in accordance with Section 3.4 which is not accepted by the
Research Committee as a DRG within * shall not become a DRG or be
included in the Research Program, and all rights to such Target
shall remain with Avalon.
(c) The Parties
agree that a DRG shall become a Reversion Target in the event of
one or more of the following:
(i) if within *
after a Target that is identified by Avalon during the Research
Term is accepted by the Research Committee for inclusion in the
Research Program as a DRG, such DRG is not selected as a SQT;
or
(ii) if within *
after a Target is selected as a DRG, (and assuming that Aventis
subsequently selects it as an SQT), such DRG is not selected as an
Advanced SQT; or
(iii) if Aventis
determines not to Develop or to continue to Develop a Collaboration
Product for an Advanced SQT; or
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
20
(iv) if Aventis
does not use * to Develop and Commercialize Collaboration Products
with respect to a selected Advanced SQT; or
(v) if, for any
reason, Aventis determines not to Develop or to discontinue
Development of a DRG.
(d) All rights to
Reversion Targets shall revert to Avalon and Avalon may use any
such Reversion Targets for any purpose, and may license Reversion
Targets to Third Parties or collaborate with Third Parties with
respect to Reversion Targets.
(e) With respect
to each SQT and each Advanced SQT that becomes a Reversion Target,
Aventis shall provide Avalon with the pre-clinical information and
data (“Aventis Target Technology”) in the Control of
Aventis at the time such Target becomes a Reversion Target with
respect to such Reversion Target that is useful for identifying
Reversion Products by use of such Reversion Targets and the
non-exclusive right and license to use and to sublicense such
Aventis Target Technology with respect to Reversion Targets,
provided that in no event shall Aventis Target Technology include
any information or data relating to compounds, molecules or
antibodies.
3.7
Aventis Responsibility. At the cost and expense of Aventis, Aventis
shall be solely responsible for Development and Commercialization
of Collaboration Product.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
21
ARTICLE 4
FEE AND MILESTONE PAYMENTS
4.1
Initial Fee. In connection with the funding of research of
Collaboration Product, Aventis shall pay to Avalon * within * of
signing of this Agreement by the Parties, which amount is
non-refundable and non-creditable.
4.2
Milestone Payments by Aventis.
(a) In partial
consideration of the rights and licenses granted to Aventis by
Avalon under this Agreement, Aventis shall pay Avalon the following
non-creditable, non-refundable milestone payments for each event
set forth below (each, an “Event”), that is achieved by
Aventis or one of its Affiliates or one of their Sublicensees,
which amounts shall be due and payable within * after of such
Event.
(i) * for each SQT
selected by Aventis.
(ii) * for each
Collaboration Product that becomes an Early Development
Candidate.
(iii) * for each
Collaboration Product for which a Phase I Clinical Trial is
initiated.
(iv) * for each
Collaboration Product for which a Phase IIB Clinical Trial is
initiated.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
22
(v) * for each
Collaboration product for which a Phase III Trial is
initiated.
(vi) * for each
Collaboration Product for which an NDA is approved by the
FDA.
(vii) * for each
Collaboration Product, upon First Commercial Sale in the United
States.
(viii) * for each
Collaboration Product, upon First Commercial Sale in
Europe.
(ix) * for each
Collaboration Product, upon First Commercial Sale in
Japan.
(b) For purposes
of clarification, (i) each of the foregoing payments shall be
made only once for each Collaboration Product and upon the first
occurrence of each event for each Collaboration Product, regardless
of the number of occurrences of each event (ii) two or more
Collaboration Products shall be considered the same Collaboration
Product for purposes of this Section 4.2(b) if such
Collaboration Products are directed at the same Target,
(iii) new formulations, indications, dosages or delivery
systems for a Collaboration Product shall not trigger additional
payments, and (iv) “initiation” with respect to a study
shall mean the date the first patient is first dosed with a
Collaboration Product in such study. In the event that a milestone
is achieved for a Collaboration Product and a previous milestone
has not been paid, then such
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
23
unpaid milestone shall become due and payable as
of the date for payment of the applicable milestone that is
achieved.
(c) Aventis shall
be entitled to select up to * no later than the * of the Effective
Date. Within * following each such selection, Aventis shall make
one-time payments to Avalon as follows: * .
ARTICLE 5
REPRESENTATIONS, WARRANTIES AND
COVENANTS
5.1
Representations and Warranties of Both Parties.
(a) Each Party
represents and warrants to the other Party that, as of the date of
this Agreement, (i) such Party is duly organized and validly
existing and has full corporate power and authority to enter into
this Agreement and to carry out the provisions hereof;
(ii) such Party has full right, power and authority to enter
into this Agreement, (iii) this Agreement has been duly
executed by such Party and constitutes a legal, valid and binding
obligation of such Party, enforceable in accordance with its terms,
and (iv) all necessary consents, approvals and authorizations
of all government authorities and other persons required to be
obtained by such Party in connection with the execution, delivery
and performance of this Agreement have been and shall be
obtained.
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
24
(b) Each Party
represents to the other Party that notwithstanding anything to the
contrary in this Agreement, the execution and delivery of this
Agreement and the performance of such Party’s obligations
hereunder (a) do not conflict with or violate such
Party’s corporate charter and bylaws or any requirement of
applicable laws or regulations and (b) do not conflict with,
violate or breach or constitute a default or require any consent
under, any contractual obligation of such Party.
(c) Each Party
represents and warrants to the other Party that as of the date of
this Agreement there is no claim, investigation, suit, action or
proceeding pending or, to the knowledge of such Party, expressly
threatened, against such Party before or by any governmental entity
or arbitrator that, individually or in the aggregate, could
reasonably be expected to (i) materially impair the ability of
such Party to perform any obligation under this Agreement or
(ii) prevent or materially delay or alter the consummation of
any or all of the transactions contemplated hereby.
5.2
Additional Avalon Representations, Warranties and Covenants. Avalon
represents, warrants and covenants to Aventis that, as of the
Effective Date:
(a) Avalon has the
full right, power and authority to grant the licenses granted to
Aventis under Section 2.1 hereof and it has not granted a
license to any Third Party under Avalon Technology which is in
conflict with the licenses granted to Aventis under Section
2.1;
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
25
(b) Avalon is the
sole owner of the Patent Rights of Section 1.5 and (i);
exclusive owner or a licensee of the Avalon Know-How, and no Third
Party has any right, title or interest in or to the Avalon Know-How
owned by Avalon; all inventors of any inventions included within
the Avalon Patent Rights of Section 1.5 have assigned their
entire right, title and interest in and to such inventions and the
corresponding Patent Rights to Avalon and (ii) to the best
knowledge of Avalon, no Person, other than those Persons named as
inventors on any patent or patent application included within the
Avalon Patent Rights of Section 1.5, is an inventor of the
invention(s) claimed in such patent car patent
application;
(c) there are no
claims, judgments or settlements against or owed by Avalon or
pending or, to its best knowledge, threatened claims or litigation
seeking to invalidate the Avalon Patent Rights;
(d) without having
made an investigation, Avalon has no actual knowledge that any
existing DRG or the use thereof in a Screen infringes a granted
patent of a Third Party.
5.3
Disclaimer of Representations. EXCEPT AS SPECIFICALLY SET FORTH
HEREIN, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY
HEREUNDER AND DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES,
INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR USE OR WITH RESPECT TO THE VALIDITY
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
26
OR ENFORCEABILITY OF AVALON
PATENTS OR THAT ACTIVITIES CONTEMPLATED BY THIS AGREEMENT OR
COLLABORATION PRODUCTS WILL NOT INFRINGE PATENT RIGHTS OF A THIRD
PARTY.
ARTICLE 6
PAYMENTS
6.1
Late Payments. In the event that any payment due hereunder is not
made when due, the payment shall accrue interest from the date due
at a rate equal to * , calculated on the number of days between the
actual date the payment is made and the date the payment was due;
provided, however, that in no event shall such rate exceed the
maximum annual interest rate permitted under applicable
law.
ARTICLE 7
PATENT PROSECUTION; ENFORCEMENT; INFRINGEMENT,
OWNERSHIP OF INVENTIONS
7.1
Patent Filing, Maintenance and Prosecution.
(a) At the cost
and expense of Avalon, Avalon shall file, prosecute and maintain
Avalon Patents, other than Joint Rights, in countries of the
Territory selected by Avalon through patent counsel selected by
Avalon, and Avalon shall keep Aventis advised with respect thereto;
such countries to include, at a minimum, the United States, all
countries of Europe, Japan and Canada. Avalon shall deliver to
Aventis the
* The asterisk
denotes the confidential portions of this exhibit have been omitted
in reliance on Rule 24b-2 of the Securities Exchange Act of
1934. The confidential portions have been submitted separately to
the Securities Exchange Commission.
27
complete texts of all Avalon Patents
fled