Exhibit 10.3
EXECUTION COPY
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT ( “ Agreement
” ) is made and entered into effective as of October
15, 2003 (the “ Effective Date ”), by and
between AVALON PHARMACEUTICALS, INC., having principal offices at
20358 Seneca Meadows Parkway, MD 20876 ( “
Avalon ” ) and MEDAREX, INC., having principal
offices at 707 State Road, Princeton, New Jersey 08540-1437, on
behalf of itself and its wholly owned subsidiary, GENPHARM
INTERNATIONAL, INC., with principal offices at 521 Cottonwood
Drive, Milpitas, California 95035 (collectively, “
Medarex ’’). Avalon and Medarex each may be
referred to herein individually as a “Party,” or
collectively as the “ Parties .”
WHEREAS, Medarex and Avalon desire to enter into a
definitive agreement to collaborate to produce fully human
antibodies to antigen targets in order to develop and commercialize
genomics-derived, Antibody-Based Products on the terms set forth
below;
NOW, THEREFORE, in consideration of the foregoing premises
and the mutual promises and covenants contained herein and other
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties, intending to be legally
bound, do hereby agree as follows;
ARTICLE 1 -
SCOPE OF COLLABORATION; COLLABORATION ACTIVITIES
Section 1.1 Scope of Collaboration . The Parties
have entered into this collaboration (such collective enterprise,
the “ Collaboration ” ) to jointly
research, develop and commercialize Collaboration Products with
respect to Collaboration Targets throughout the Territory as set
forth in this Agreement. Any capitalized terra used in this
Agreement not otherwise defined herein shall have the meaning set
forth on Appendix A .
Section 1.2 Research Activities.
1.2.1 General . Under the direction and supervision of the
Steering Committee, the Parties shall use Commercially Reasonable
Efforts to conduct their respective research activities in
accordance with this Agreement, each Project Plan and each Project
Budget.
1.2.2 Identification of Collaboration Targets . The list of
Antigens attached hereto as Appendix C sets forth the
initial list of Collaboration Targets (the “Initial
Collaboration Targets”). Such list may be amended pursuant to
Section 1.7 or 5.1.2, by the express written agreement of
Medarex and Avalon or as follows:
(a) Within the sole discretion of and as selected by
Avalon, during the Target Entry Period (as defined in
Section 1.2.2(e)), Avalon may identify to Medarex Antigens for
consideration by Medarex, with it being expressly understood that
Avalon is not under any obligation to do so. In conjunction with
identification of any such Antigen, Avalon shall promptly provide
to Medarex the following information and materials (“
Antigun Evaluation Materials ” ):
* The asterisk
denotes that 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 and Exchange Commission.
(i) a written description of the applicable Antigen,
including DNA and amino acid sequences thereof, when
available;
(ii) the human tissue and/or cell type expression
profile for such Antigen;
(iii) all other scientific data in the possession of
Avalon or its Affiliates relating to such Antigen;
(iv) all information regarding (A) the
proprietary status of such Antigen, (B) the intellectual
property rights Controlled by Avalon and its Affiliates with
respect to such Antigen, (C) any Patent, know-how,
intellectual property or other rights assigned, transferred,
granted or conveyed by Avalon or its Affiliates to any Third
Parties that is inconsistent with rights to be granted under this
Agreement with respect to an Antibody Product against said Antigen,
(D) any agreements by or among Avalon or its Affiliates and
any Third Parties that is inconsistent with rights to be granted
under this Agreement with respect to an Antibody Product against
said Antigen, (E) any potential restrictions (contractual,
patent or otherwise) that would limit or otherwise affect the
Parties’ right to fully Exploit any Collaboration Products
with respect thereto, and (F) the extent known, any potential
Third-Party Payments that would be owed in connection with the
Exploitation of Antibody Products with respect to such Antigen
under this Agreement or a Unilateral Development and
Commercialization Agreement;
(v) existing and available models for preclinical
validation of Antibody Products against such Antigen;
(vi) a list of expected indications for Antibody
Products against such Antigen,
(vii) the commercial and scientific rationale for why
Avalon believes such Antigen is a promising target for the
development of Antibody-Based Products; and
(viii) all other relevant information in
Avalon’s or its Affiliates’ possession with respect to
such Antigen,
(b) Beginning on the day that either (i) Medarex
notifies Avalon in writing that Medarex is in receipt of the
complete Antigen Evaluation Materials with respect to an Antigen or
(ii) Avalon notifies Medarex in writing that, to the best of
its knowledge, Avalon has delivered all of the Antigen Evaluation
Materials that is in its possession with respect to an Antigen, and
* days thereafter, (the “ Evaluation Period ”),
Medarex shall have the exclusive right to determine whether such
Antigen shall become a Collaboration Target under this Agreement
and shall notify Avalon of its determination with respect to such
Antigen. In the event Medarex receives Antigen Evaluation Materials
for a given Antigen pursuant to Section 1.2.2(a), but does not
believe such materials are sufficiently complete to enable Medarex
* whether to accept or decline such Antigen pursuant to the
preceding sentence, the Parties shall * additional analyses to be
performed by Avalon in order to complete the Antigen
Evaluation
* The asterisk
denotes that 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 and Exchange Commission.
2
Materials, but Avalon shall not
be obligated to perform such additional analyses. At any time prior
to the commencement of the Evaluation Period with respect to an
Antigen, Avalon shall have the right to withdraw such Antigen from
consideration and such Antigen shall be a Reversion Target subject
to the obligations of Section 1.7.
(i) In -the event Medarex accepts such Antigen into
the Collaboration as a Collaboration Target, Appendix C
shall be deemed to be amended accordingly and the Parties shall *
to develop a preliminary Project Plan and Project Budget for the
discovery and development of Antibody Products with respect to such
Antigen in the form attached hereto as Appendix E ; *
.
(ii) In the event Medarex does not accept such Antigen
within the applicable Evaluation Period, such Antigen shall not be
deemed to be a Collaboration Target and Medarex shall have no
further rights with respect thereto under this Agreement and Avalon
shall have no further obligations with respect thereto under this
Agreement.
(iii) *
(c) Upon designation of an Antigen as a Collaboration
Target pursuant to Section 1.2.2(b), the Parties shall * a
written description of such Antigen, including the name of the
Collaboration Target and its complete DNA sequence end GenBank
accession number, which descriptions shall be included on
Appendix C .
(d) As the Parties gain greater understanding of each
Collaboration Target and the potential utility of Antibody Products
thereto, they shall update the description of such Collaboration
Target on Appendix C to more accurately reflect what
Antigens, or portions thereof, are included in the
Collaboration.
(e) The “ Target Entry Period ”
shall commence on the Effective Date and shall continue until *
unless (i) earlier terminated by (A) the unanimous
agreement of the Parties, or (B) either Party pursuant to
Article 8; or (ii) extended by unanimous agreement of the
Parties. The termination or expiration of the Target Entry Period
shall not constitute a termination of this Agreement.
1.2.3 Identification of Applicable Assays and Success
Criteria . As part of the Project Plan for a given
Collaboration Target, the Steering Committee will:
(a) identify the Immunogen(s) (each, an “
Immunogen ”) to be used to enable Medarex to perform
its activities pursuant to Section 1.2.5;
(b) * ;
(c) develop an experimental plan to identify a set of
assays (each, an “ Assay ”) for screening Assay
Candidates against such Collaboration Target;
(d) determine which Party will be responsible for
delivering the Assays to the Collaboration; and
* The asterisk
denotes that 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 and Exchange Commission.
3
(e) develop guidelines that will allow the
establishment of criteria (the “ Assay Success
Criteria ” ) for determining, subject to
Section 1.2.6, whether an Assay Candidate should become a
Collaboration Antibody,
The Steering Committee may elect
to use a Third Party to provide one or more Immunogen(s) to the
Collaboration. In addition, the Steering Committee may elect to
have a Third Party develop and/or perform one or more of the
Assays.
1.2.4 Allocation of Costs . * , all costs associated with
identifying Collaboration Targets, preparing and furnishing to
Medarex complete Antigen Evaluation Materials with respect thereto,
and creating and delivering the Immunogen(s) to Medarex (the
“ Avalon Research Activities ”) shall be borne *
, but Avalon shall have no obligation to provide any Antigen
Evaluation Materials. With respect to the Collaboration Targets
that exist as of the Effective Date, all costs associated with
immunizing the HuMAb Mice and raising a panel of different
Antibodies to the applicable Collaboration Target pursuant to the
last sentence of Section 1.2.5 (the “ Medarex
Research Activities ”) shall be borne * . * . All other
costs and expenses incurred by the Parties in performing their
activities under this Section 1.2 shall be governed by
Section 4.1.2.
1.2.5 Raising of Antibodies by Medarex . * shall provide to
Medarex sufficient Immunogen for each Collaboration Target to
enable Medarex to perform its activities pursuant to this Section
1.2.5. Upon the delivery of such Immunogen, Medarex shall * to
immunize the HuMAb Mice to raise a panel of different Antibodies to
the applicable Collaboration Target.
1.2.6 Selection of Assay Candidates; Assay Screening; Selection
of Collaboration Antibodies.
(a) Medarex shall select a subset of the Antibodies
raised pursuant to Section 1.2.5 to become “ Assay
Candidates ”. As set forth under the applicable Project
Plan, the Parties shall run each Assay Candidate through the
applicable Assays. Upon completion of the Assay screening for a
given Assay Candidate, each Party will be provided with the results
of such screening (including the raw data underlying such results).
The Steering Committee will then determine whether the Assay
Candidate has met the applicable Assay Success Criteria. Subject to
Section 1.2.6(b), each Assay Candidate that meets the
applicable Assay Success Criteria shall be deemed to be a “
Collaboration Antibody ”; provided ,
however , the Steering Committee may, in its sole discretion
(i) decide that an Assay Candidate that meets the Assay
Success Criteria shall nonetheless not be deemed to be a
Collaboration Antibody, or (ii) decide that an Assay Candidate that
does not meet the Assay Success Criteria shall nonetheless be
deemed to be a Collaboration Antibody.
(b) The Parties shall determine the amino acid
sequence of at least one heavy chain variable region corresponding
to a contiguous portion spanning CDR 1 through CDR3 and defining a
complete antibody-heavy chain Antigen binding domain (a “
Binding Sequence ” ) for each Assay Candidate
that is selected pursuant to Section 1.2.6(a) to be a
Collaboration Antibody and shall provide such sequence information
to Medarex.
* The asterisk
denotes that 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 and Exchange Commission.
4
Notwithstanding
Section 1.2.6(a), Medarex shall have the right to veto any
such Assay Candidate on written notice to Avalon within * days of
its receipt of the correct sequence data for any such Assay
Candidate, if Medarex (i) is researching or developing, or has
researched or developed, ether, alone or in collaboration with a
Third Party, any such Assay Candidate, or (ii) has previously
granted a Third Party rights with respect to any Antibody that has
the same Binding Sequence as such Assay Candidate, whereupon such
Assay Candidate shall not become a Collaboration Antibody and all
amounts of such Assay Candidate (and any cell lines expressing such
Assay Candidate and other Mice Materials with respect to such Assay
Candidate) produced pursuant to this Agreement will be
destroyed.
1.2.7 Effect of Designation of Collaboration, Antibodies. .
Any Antibody that is designated a Collaboration Antibody in
accordance with Section 1.2.6 shall be exclusive to the
Collaboration. Except as otherwise provided in this Agreement, once
an Antibody is designated a Collaboration Antibody
, all costs associated with the research,
development, manufacturing and commercialization of such
Collaboration Antibody shall * , as more fully described in Section
4.1. Any Antibodies with
respect to a Collaboration Target (and any cell lines expressing
such Antibodies and other Mice Materials with respect to such
Antibodies) produced under this Agreement that are not designated
as Collaboration Antibodies or back-up Collaboration Antibodies by
the Steering Committee shall be destroyed by Medarex, unless the
Parties agree otherwise,
1.2.8 Lead Collaboration Antibodies . Out of the pool of
Collaboration Antibodies against a given Collaboration
Target, the Steering Committee will
select the Collaboration Antibody that it believes to be most
promising for development and commercialization and it will then
move such Collaboration Antibody into Production Process
Development. Each Collaboration Antibody that is put into
Production Process Development shall be deemed to be a “
Lead Collaboration Antibody ”. It is understood that
the Steering Committee may, over time, select more than one Lead
Collaboration Antibody against a given Collaboration Target, or
substitute one Lead Collaboration Antibody for another. Upon
designation of each Lead Collaboration Antibody, * of the cost of
Production Process Development for such Lead Collaboration
Antibody. With respect to each Lead Collaboration Antibody, the
Steering Committee shall solicit bids from suppliers to perform the
Production Process Development. Each Party shall have the right to
submit a bid on such terms as it desires. The Steering Committee
shall use * to enter into a development agreement with the supplier
that is best able to meet the Parties’ requirements, taking
into consideration such factors as price, quality, capacity,
quantity, reliability and reputation. In the event the Steering
Committee selects a Party to perform Production Process Development
pursuant to this Section 1.2.8, the price and other terms and
conditions of such Production Process Development shall be based on
arm’s length negotiations with the Steering
Committee.
1.2.9 Identification of Restrictions on Exploitation of
Collaboration Products . Upon the designation of the first
Collaboration Antibody with respect to a Collaboration Target,
unless otherwise agreed by the Steering Committee, the
Collaboration shall solicit a formal patent review and opinion
regarding such Collaboration Target, and Antibody Products with
respect thereto, from an outside law firm selected by the Steering
Committee. The costs of such formal opinion shall be * .
* The asterisk
denotes that 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 and Exchange Commission.
5
Section 1.3 Project Plan and Project Budget .
Upon designation of a given Antigen as a Collaboration Target
pursuant to Section 1.2.2, the Parties shall jointly develop
and implement a project plan (each a “ Project Plan
”) and a project budget (each a “ Project Budget
”) for the research, development, manufacture and
commercialization of Collaboration Products against such
Collaboration Target. It is understood that each such respective
Project Plan and Project Budget initially will cover the
early-stage research and development of Collaboration Products with
respect to such respective Collaboration Target, but that the
components of each Project Plan and Project Budget will evolve as
the applicable Collaboration Products move through the research,
development, manufacture and commercialization life cycle. The
Parties, through the Steering Committee, shall endeavor to review
and update each Project Plan and Project Budget at least
annually.
Section 1.4 Performance Standards . Each Party
shall perform, or cause to be performed, its respective activities
hereunder in good scientific manner, and in compliance in all
material respects with all Applicable Law and * to
(a) research, develop, file for Regulatory Approval and
commercialize one or more Collaboration Products with respect to
each Lead Collaboration Antibody, and (b) achieve the
objectives of each Project Plan in accordance with each Project
Budget, in each case, efficiently and expeditiously by allocating
sufficient time, effort, equipment and skilled personnel to
complete -
such activities successfully and
promptly.
Section 1.5 Product Trademarks . The Parties
shall develop Product Trademarks for each Collaboration Product
that will be commercialized. Such Product Trademarks shall not be
confusingly similar to, misleading or deceptive with respect to, or
dilute any of the Trademarks owned or Controlled by either of the
Parties, or any part of such Trademarks. No Party or any of its
Affiliates or sublicensees shall commercialize a Collaboration
Product under any Trademark other than the - Product Trade marks. No Party or any of its
Affiliates or sublicensees shall use in its business any Trademark
that is confusingly similar to, misleading or deceptive with
respect to, or dilutes any of the Product Trademarks or any other
Trademarks used to identify or distinguish a Collaboration Product,
or any part of the foregoing. The Steering Committee shall oversee
the filing, prosecution and maintenance of all Product Trademark
registrations. * in the costs and expenses of such filing,
prosecution and maintenance. Subject to Applicable Law, the label
of any Collaboration Products shall include, at Avalon’s sole
discretion, the name of Avalon and, at Medarex’s sole
discretion, the name of Medarex.
Section 1.6 Supply of Collaboration Products .
With respect to clinical and commercial supplies of Collaboration
Products, the Steering Committee shall solicit bids from suppliers
to supply the Parties’ requirements thereof. Each Party shall
have the right to submit a bid on such terms as it desires. The
Steering Committee shall use Commercially Reasonable Efforts to
enter into a supply agreement with the supplier that is best able
to meet the Parties’ requirements, taking into consideration
such factors as price, quality, capacity, quantity, reliability and
reputation. In the event the Steering Committee selects a Party to
produce clinical and/or commercial supplies pursuant to this
Section 1.6, the price and other terms and conditions of such
supply shall be based on arm’s length negotiations with the
Steering Committee.
Section 1.7 Reversion of Collaboration Targets .
If, notwithstanding the Commercially Reasonable Efforts of the
Parties, no Collaboration Antibodies have been
* The asterisk
denotes that 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 and Exchange Commission.
6
designated with respect to a
Collaboration Target pursuant to Section 1.2.6 within * , or
such other period as the Parties may agree, after the immunization
of the HuMAb Mice with respect to such Collaboration Target
pursuant to Section 1.2.5, * , then (a) such Antigen
shall cease to be a Collaboration Target (such Antigen, a
“Reversion Target”), and Appendix C shall
be amended accordingly, (b) any Antibodies with respect
thereto shall not become Collaboration Antibodies, (c) any
Antibody Products with respect thereto shall not become
Collaboration Products, and (d) any licenses granted pursuant
to Article 3, with respect to such Antigen, Antibody or
Antibody Product shall terminate, and, subject to
Section 7.1.5, Medarex shall have no further rights under this
Agreement with respect to such Antigen. Promptly upon such
designation, the Parties shall destroy all Antibody Products,
Antibodies, Mice Materials, Immunogens and other Biological
Materials created under this Agreement with respect to such a
Reversion Target.
ARTICLE 2 -
OPERATION OF THE COLLABORATION
Section 2.1 Steering Committee.
2.1.1 Formation of Steering Committee . The Parties shall
establish a joint committee (the “ Steering Committee
” ), which -shall oversee the research, development
and commercialization activities hereunder. Each of Avalon and
Medarex shall appoint an equal number of representatives with the
requisite experience and seniority to enable them to make decisions
on behalf of the Parties with respect to the Collaboration. From
time to time, Avalon and Medarex each may substitute any of its
representatives to the Steering Committee.
2.1.2 Responsibilities . The Steering Committee shall, in
addition to its other responsibilities described in this Agreement:
(a) prioritize the research, development, manufacturing and
commercialization activities with respect to Collaboration Targets,
Collaboration Antibodies and Collaboration Products;
(b) subject to Section 1.3, allocate responsibility for
such activities between Avalon and Medarex taking into
consideration their relevant expertise and available resources;
(c) develop and implement a strategy for researching,
developing, manufacturing, obtaining and maintaining Regulatory
Approvals for, and commercializing, the Collaboration Products;
(d) determine whether to enter into any agreements pursuant to
Section 7.4 or otherwise that would give rise to Third-Party
Payments; (e)establish such subcommittees as deemed appropriate by
the Steering Committee; and (f) take such other actions as are
set forth in this Article 2 or as the Parties may unanimously
agree. The Steering Committee may evaluate additional technologies
that may be necessary or beneficial to the Collaboration and may
recommend the acquisition or in-licensing of these technologies to
the Parties.
2.1.3 Procedural Rules for the Steering
Committee.
(a) Generally. Except as explicitly set forth in this
Section 2.1.3, the Steering Committee shall establish its own
procedural rules for its operation.
(b) Voting. The Steering Committee shall take action by
unanimous consent of Avalon and Medarex, with each such Party
having a single vote, irrespective of the number of representatives
actually in attendance at a meeting, or by a written resolution
signed
* The asterisk
denotes that 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 and Exchange Commission.
7
by the designated representatives
of each of Avalon and Medarex. A quorum shall be established only
if at least one member appointed by Avalon and at least one member
appointed by Medarex is in attendance.
Section 2.2 Progress Reports . Within * after *
, or as otherwise required by the Steering Committee, each Part
shall provide to the other Party a written progress report, which
shall (a) describe any research, development or
commercialization activities with respect to Collaboration Targets
or Collaboration Products and any other work relating to the
Collaboration Targets and Collaboration Products that it has
performed, or caused to be performed, since the last such report,
(b) evaluate the work performed in relation to the goals of
this Agreement and the applicable Project Plan, and
(c) provide such other information as may be required by this
Agreement and the applicable Project Plan or reasonably requested
by the other Party relating to such activities. In addition to the
progress reports provided hereunder, it is contemplated that the
Parties will maintain informal communications through the Steering
Committee and their day-to-day activities under this
Agreement.
Section 2.3 Disputes; Dispute
Resolution.
2.3.1 Referral to Steering Committee . Any dispute that may
arise relating to the terms of this Agreement or the activities of
the Parties hereunder shall be brought to the attention of the
Steering Committee, which shall attempt in good faith to achieve a
resolution. Either Party may convene a special meeting of the
Steering Committee for the purpose of resolving
disputes.
2.3.2 Referral to Chief Executive Officers of the Parties .
If the Steering Committee is unable to resolve such a dispute
within * of the first presentation of such dispute to the Steering
Committee, and with respect to all other disputes, including the
failure to obtain a unanimous vote in the Steering Committee, such
dispute shall be referred to the Chief Executive Officers of each
of the Parties (or their respective designees) who shall use their
good faith efforts to mutually agree upon the proper course of
action to resolve the dispute.
2.3.3 Referral to Chief Executive Officer of Medarex . Any
disputes arising with respect to Mice-Related Technology shall be
resolved conclusively by the Chief Executive Officer of Medarex (or
his or her designee), who shall * to the comments of the Chief
Executive Officer of Avalon (or his or her designee) in resolving
such matter.
2.3.4 Unresolved Disputes . If any dispute bother than those
provided for in Section 2.3.3) is not resolved by the Chief
Executive Officers of the Parties (or their designees) within *
after such dispute is referred to them, or such longer period as
the Chief Executive Officers (or their respective designees) may
collectively agree, then either Party shall have the right
(a) if such dispute relates to * to refer such dispute to an
Expert for expedited arbitration as set forth in
Section 2.3.5, or (b) with respect to any other dispute,
including with respect to a Party’s interpretation of, or any
allegation of breach of, this Agreement, to litigate such dispute
in accordance with Section 11.5 or to pursue such other
dispute resolution mechanism as the Parties may agree, except that
disputes under Section 7.3.1(a) shall be resolved in
accordance with Section 7.3.1(a).
* The asterisk
denotes that 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 and Exchange Commission.
8
2.3.5 Expedited Arbitration.
(a) With respect to disputes under Section 2.3.4
above that are not resolved by the Chief Executive Officers of the
Parties (or their designees) pursuant to Section 2.3.2, upon
written request by either party to the other Party, the Parties
shall promptly negotiate in good faith to appoint a mutually
acceptable disinterested, conflict-free individual got affiliated
with either Party, with scientific, technical and regulatory
experience with respect to the development of Antibody-Based
Products necessary to resolve such dispute (an “
Expert ”). If the Parties are not able to agree within
* after the receipt by a Party of the written request in the
immediately preceding sentence, the CPR Institute for Dispute
Resolution, or such other similar entity as the Parties may agree,
shall be responsible for selecting an Expert within * of being
approached by a Party. The fees and costs of the Expert and the CPR
Institute for Dispute Resolutions (or such other entity) shall *
.
(b) Within * after the designation of the Expert, the
Parties shall each simultaneously submit to the Expert and one
another a written statement of their respective positions on such
disagreement. Each Party shall have * from receipt of the other
Party’s submission to submit a written response thereto,
which shall include any scientific and technical information in
support thereof. The Expert shall have the right to meet with the
Parties, either alone or together, as necessary to make a
determination.
(c) No later than * after the designation of the
Expert, the Expert shall make a determination by selecting the
resolution proposed by one of the Parties that as a whole is the
most fair and reasonable to the Parties in light of the totality of
the circumstances and shall provide the Parties with a written
statement setting forth the basis of the determination in
connection therewith. The decision of the Expert shall be final and
conclusive, absent manifest error.
ARTICLE 3 -
GRANT OF RIGHT
Section 3.1 License Grants for Collaboration
Activities.
3.1.1 Medarex Grant . Subject to Section 3.3 and the
other terms and conditions of this Agreement, Medarex hereby grants
to Avalon and its Affiliates a co-exclusive (with Medarex and its
Affiliates), fully-paid, royalty-free license, with the right to
sublicense solely as provided in Sections 3.3.5 and 3.4, under
the Medarex Technology and the Collaboration Technology, in each
case to perform Avalon’s activities under Section 1.2,
and (b) jointly Exploit the Collaboration Products in
accordance with this Agreement.
3.1.2 Avalon Grant . Subject to the terms and conditions of
this Agreement, Avalon hereby grants to Medarex and its Affiliates
a co-exclusive (with Avalon and its Affiliates), fully-paid,
royalty-free license, with the right to sublicense solely as
provided in Section 3.4, under the Avalon Technology and the
Collaboration Technology, in each case to (a) perform
Medarex’s activities under Section 1.2, and
(b) jointly Exploit the Collaboration Products in accordance
with this Agreement.
* The asterisk
denotes that 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 and Exchange Commission.
9
Section 3.2 Product Trademarks
,
for Collaboration
Products.
3.2.1 Medarex Grant . Subject to the terms and conditions of
this Agreement, Medarex hereby grants to Avalon and its Affiliates
a co-exclusive (with Medarex and its Affiliates), fully-paid,
royalty-free license, with the right to sublicense solely as
provided in Section 3.4, to use the Product Trademarks to
Exploit the Collaboration Products in accordance with this
Agreement.
3.2.2 Avalon Grant . Subject to the terms and conditions of
this Agreement, Avalon hereby grants to Medarex and its Affiliates
a co-exclusive (with Avalon and its Affiliates), fully-paid,
royalty-free license, with the right to sublicense solely as
provided in Section 3.4, to use the Product Trademarks to
Exploit the Collaboration Products in accordance with this
Agreement.
Section 3.3 Exclusivity, Reserved Rights and
Pre-Existing Grants.
3.3.1 Antigen Exclusivity . Subject to Sections 3.3.2,
3.3.3 and 3.3.4, the Parties acknowledge and agree that no Party
shall engage, directly or indirectly, on behalf of itself or any
other party, in the research, development, commercialization or
other Exploitation of Antibody-Based Products with respect to any
Collaboration Target other than the Collaboration Products and
Unilateral Products as provided in this Agreement and any related
agreements between the Parties.
3.3.2 Research and Commercialization Agreements . Medarex
shall have the right to (a) grant licenses and other rights to
other parties, under the Medarex Technology for such parties to
Exploit Antibody Products (but not Collaboration Products) with
respect to Antigens, including Collaboration Targets,
(b) transfer Medarex Know-How to such parties in connection
therewith, including by providing instruction with respect to the
use and immunization of HuMAb Mice, and assistance with respect to
the Mice-Related Technology, (c) develop production processes
for, and manufacture, such Antibody Products, and (d) receive
license fees, milestone payments, royalties and other remuneration
in connection therewith, but, in connection with clause (a), (b),
(c) or (d) above, * (each agreement with respect to the
foregoing, a “ Research and Commercialization
Agreement ”). For the avoidance of doubt, Medarex shall
not disclose or transfer any Avalon Technology or, subject to
Section 7.1.5, Collaboration Technology to any Third Party in
connection with a Research and Commercialization
Agreement.
3.3.3 Retained Rights . Notwithstanding anything in this
Agreement to the contrary, Medarex does hereby retain the right to
(a) enter into collaborations or other agreements with, and to
grant licenses and other rights under the Medarex Technology to,
Third Parties to Exploit Antibody Products with respect to Antigens
other than Collaboration Targets, and/or (b) independently
Exploit Antibody Products with respect to Antigens other than
Collaboration Targets.
3.3.4 Existing Grants . The Parties further acknowledge and
agree that (a) pursuant to the Cross-License Agreement,
Medarex has granted a non-exclusive license under certain Medarex
Patents to exploit Antibody Products, including Collaboration
Products, with
* The asterisk
denotes that 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 and Exchange Commission.
10
respect to Antigens, including
the Collaboration Targets, in the Territory; and (b) pursuant
to certain existing agreements with Third Parties, Medarex has
granted exclusive rights under the Medarex Technology to Exploit
Antibody Products with respect to Antigens other than Collaboration
Targets, which Antibody Products could be the same as Collaboration
Products.
3.3.5 Cross-License Agreement . * .
(a) * .
(b) * .
(c) * .
Section 3.4 Sublicenses . Subject to
Section 3.3.5, each Party shall have the right to grant
sublicenses under the licenses granted in Sections 3.1 and 3.2
to (a) Affiliates without the approval of the applicable
licensor, provided that any such sublicensor shall remain jointly
and severally liable for the performance or non-performance of any
such Affiliate sublicensee, and (b) Third Parties pursuant to
Section 5.2 or as necessary to perform the commercialization
activities assigned to such Party under a Project Plan, with the
prior approval of the applicable licensor, not to be unreasonably
withheld or delayed, which approval shall be deemed to be granted
with respect to a sublicense if the licensor fails, within twenty
(20) business days of its receipt of a written notice from the
sublicensing Party setting forth in reasonable detail the nature of
such sublicense and the identity of the sublicensee, to notify such
sublicensing Party that it withholds its consent to such sublicense
and the reasons therefor. Notwithstanding the previous sentence,
the grant of any such sublicense shall not relieve the sublicensing
Party of its obligations under this Agreement.
Section 3.5 License Limitations . Each Party
hereby covenants to the other Party that neither such first Party
nor any of its Affiliates, licensees or sublicensees shall use or
practice the Technology of such other Party (other than the
Collaboration Technology, which shall be governed by
Section 7.1.5), directly or indirectly, on behalf of itself or
any other party, for any purpose other than as permitted under
Section 3.1 and in particular, but without limiting the
generality of the foregoing, for any research, development,
commercialization or other Exploitation of an Antibody Product or
any other product or method, other than, a Collaboration Product or
a Unilateral Product as provided hereunder or in the applicable
Unilateral Development and Commercialization Agreement.
Section 3.6 No Other Rights . For the avoidance
of doubt, Medarex and its Affiliates shall have no right, express
or implied, with respect to the Avalon Technology and Avalon and
its Affiliates shall have no right, express or implied, with
respect to the Medarex Technology, in each case except as expressly
provided in Section 3.1.
Section 3.7 Additional Mice . * .
* The asterisk
denotes that 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 and Exchange Commission.
11
ARTICLE 4 -
FINANCIAL PROVISIONS
Section 4.1 Profit and Expense Allocation with
Respect To Collaboration Products.
4.1.1 Operating Profits and Operating Losses . Except as
otherwise provided in this Agreement, the Parties shall * in the
Operating profits and Operating Losses, as applicable, with respect
to the collaboration Products, as set forth in this Section. Within
* after the end of * in which Operating Profits or Operating Losses
are recognized with respect to a Collaboration Product, each party
shall provide the other Party with a statement detailing its
Operating Profits or Operating Losses for such Collaboration
Product for such calendar quarter on a country-by-country basis,
which statement shall set forth in reasonable detail any Net Sales
by such Party or its Affiliates, any Commercialization Expenses and
any Other Operating (Income)/Expense, including a detailed
breakdown of the components of the foregoing, with respect to such
Collaboration Product, * (“ Authorized Commercialization
Expenses ”). Within * after the end of each calendar
quarter, the Parties shall -make payments to one another so that *
the Operating Profits or Operating Losses, as applicable, for such
calendar quarter for each Collaboration Product.
4.1.2 Research and Development Expenses . Except as
otherwise provided in this Agreement, * in the cost and expense of
all Authorized R&D Expenses (as defined below) incurred by or
on behalf of the Parties in connection with their activities other
than the Avalon Research Activities and the Medarex Research
Activities, Within * after the end of * , each Party shall furnish
the Steering Committee with a statement (a) detailing the
costs and expenses actually incurred in connection with the
research and development activities (including phase IV studies and
any other post-Regulatory Approval research and development
activities) performed by or on behalf of such Party during such
calendar quarter, * (the “ Authorized R&D Expenses
”) and (b) comparing such expenses to date with the
projections set forth in the Project Budget. Within * days after
the end of each calendar quarter, Medarex and Avalon shall make
payments to one another so that * for such calendar quarter . For
the avoidance of doubt, neither Party shall be reimbursed for any
of its internal costs of Production Process Development for
clinical or commercial (but not preclinical) supplies of
Collaboration Products unless such costs are expressly agreed to
by’ the Parties in a project Budget or incurred under a
separate agreement, entered into pursuant to Section 1.2.8 or
1.6.
Section 4.2 Payment Method. All amounts
due by one Party hereunder shall be paid in U.S. dollars by wire
transfer in immediately available funds to an account designated by
the receiving Party. Any payments or portions thereof due hereunder
which are not paid on the date such payments are due under this
Agreement shall bear interest at a rate equal to * , calculated on
the number of days such payment is delinquent, * .
Section 4.3 Currency; Foreign Payments . If any
currency conversion shall be required in connection with any
payment hereunder, such conversion shall be made by using the
arithmetic mean of the exchange rates for the purchase of U S.
dollars as published in The Wall Street Journal, Eastern Edition,
on the last business day of each month in the calendar quarter
to
* The asterisk
denotes that 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 and Exchange Commission.
12
which such payments relate. If at
any time legal restrictions prevent the prompt remittance of any
Operating Profits with respect to Net Sales in any jurisdiction,
the applicable Party may notify the other and make such payments by
depositing the amount thereof in local currency in a bank account
or other depository in such country in the name of the receiving
Party or its designee, and such Party shall have no further
obligations under this Agreement with respect thereto.
Section 4.4 Taxes . A Party may deduct from any
amounts it is required to pay pursuant to this Agreement an amount
equal to that withheld for or due on account of any taxes (other
than taxes imposed on or measured by net income) or similar
governmental charge imposed by a jurisdiction other than the United
States (“ Withholding Taxes ”). At the receiving
Party’s request, the paying Party shall provide the receiving
Party a certificate evidencing payment of any Withholding Taxes
hereunder and shall reasonably assist the receiving Party, at the
receiving Party’s expense, to obtain the benefit of any
applicable tax treaty.
Section 4.5 Records Retention; Audit.
4.5.1 Record Retention . Each Party shall maintain (and
shall ensure that its Affiliates and sublicensees shall maintain)
complete and accurate books, records and accounts that fairly
reflect their respective (a) Authorized R&D Expenses,
Authorized Commercialization Expenses, Other Operating
(Income)/Expenses, any costs and expenses reimbursable under
Article 7, and any other costs and expenses reimbursable or
otherwise shared by the Parties hereunder (collectively, the
“ Collaboration Expenses ”), and (b) Net
Sales of Collaboration Products and operating Profits and Operating
Losses with respect to Collaboration Products, in each case in
sufficient detail to confirm the accuracy of any payments required
hereunder and in accordance with GAAP, which books, records and
accounts shall be retained by such Party until * .
4.5.2 Audit . Each Party shall have the right to have an
independent certified public accounting arm of nationally
recognized standing, reasonably acceptable to the audited Party, to
have access during normal business hours, and upon reasonable prior
written notice, to such of the records of the other Party (and its
Affiliates and sublicensees) as may be reasonably necessary to
verify the accuracy of such Collaboration Expenses, Net Sales, or
Operating Profits or operating Losses, as applicable, for any *
ending not more than * prior to the date of such request;
provided , however , that neither Party shall have
the right to conduct more than * such audit in any * . The
accounting firm shall disclose to each Party whether such
Collaboration Expenses, Net Sales, or Operating Profits or
Operating Losses, as applicable, are correct or incorrect and the
specific details concerning any discrepancies, No other information
shall be provided to the requesting party. * . The results of such
accounting firm shall be final, absent manifest error.
4.5.3 Payment of Additional Amounts . If, based on, the
results of such audit, additional payments are owed by a Party
under this Agreement, such Party shall make such additional
payments, * , within * after the date on which such accounting
firm’s written report is delivered to such Party,
* The asterisk
denotes that 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 and Exchange Commission.
13
4.5.4 Confidentiality . The auditing Party shall treat all
information subject to review under this section 4.5 in accordance
with the confidentiality ‘Provisions of Article 6 and
shall cause its accounting firm to enter into a reasonably
acceptable confidentiality agreement with the audited Party
obligating such firm to maintain all such financial information in
confidence pursuant to such confidentiality agreement.
ARTICLE 5 -
UNILATERAL AND THIRD PARTY DEVELOPMENT AND
COMMERCIALIZATION
Section 5.1 Unilateral Development and
Commercialization.
5.1.1 Opting-Out by a Party . Each Party (i.e., Medarex, on
the one hand, and Avalon, on the other hand) (the “
Opting-Out Party ”) shall have the right, on * written
notice to the other (an “ Opt-Out Notice ”), to
elect not to proceed with the research, development and
commercialization (“ Opt-Out ”) of all
Collaboration Products with respect to a given Collaboration Target
at any time, provided that such Party shall be responsible for all
budgeted costs and expenses associated with the research and
development activities with respect to such Collaboration
Product(s) that such Party has committed to in the applicable
Project Budget as necessary to complete that phase of research and
development (e.g., toxicology studies in support of an IND or phase
I, phase II or phase III studies) that was under way when such
Party Opted-Out. By way of clarification, if a Party Opts-Out of a
Collaboration Product with respect to a collaboration Target, such
Party will be deemed to have Opted-Out with respect to all Antibody
Products with respect to the same Collaboration Target.
5.1.2 Rights and Obligations of Parties with Respect To
Unilateral Products.
(a) Unilateral Development and Commercialization. Upon
receipt by a Party of an Opt-Out Notice, the receiving Party shall
have the right, on written notice to the Opting-Out Party within *
following receipt of the Opt-Out notice (an “ Election
Notice ”), to proceed unilaterally with the research,
development and commercialization of all Collaboration Antibodies
and Collaboration Products to the applicable Collaboration Target
(each such antibody and product, a “ Unilateral
Product ”) pursuant to the separate agreement with the
Opting-Out Party attached hereto as Appendix D-1 or
Appendix D-2 , as applicable (each, a “
Unilateral Development and Commercialization Agreement
”). Upon receipt by Avalon of an Election Notice from Medarex
with respect to a Collaboration Target, the Unilateral Development
and Commercialization Agreement set forth in
Appendix D-1 shall be automatically amended to include
such Collaboration Target and any Antibody Products with respect
thereto. Upon receipt by Medarex of an Election Notice from Avalon
with respect to a Collaboration Target, the Unilateral Development
and Commercialization Agreement set forth in
Appendix D-2 shall be automatically amended to include
such Collaboration Target and any Antibody Products with respect
thereto. Upon such amendment of a Unilateral Development and
Commercialization Agreement pursuant to this Section 5.1.2,
the applicable Antigen shall cease to be a Collaboration Target and
Appendix C shall be amended accordingly, all Antibodies
and all Antibody Products with respect to such former Collaboration
Target shall cease to be
* The asterisk
denotes that 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 and Exchange Commission.
14
Collaboration Antibodies or
Collaboration Products, as applicable, and any licenses granted
pursuant to Article 3, with respect to such Antigen and any
Antibodies and Antibody Products with respect thereto, shall
terminate. The Parties shall work together to ensure a smooth and
orderly transition of the Unilateral Products to the non-Opting-Out
Party, including the assignment of any contracts with respect to
the Exploitation of such Unilateral Products to the non-Opting-Out
Party, and the assumption by the non-Opting-Out Party of any
obligations thereunder. Except for the obligations provided for in
Section 5.1.1, the Opting-Out Party shall have (x) no
further financial obligation to support or otherwise fund any
additional efforts in respect of such Unilateral Products, and
(y) no obligation, responsibility, or authority regarding such
additional efforts in respect of such Unilateral Products. In the
event that neither Party elects to proceed with the research,
development or commercialization of any Collaboration Product with
respect to a Collaboration Target, the rights and obligations of
the Parties with respect to such Collaboration Target shall be
governed by Sections 5.2 and 5.3.
(b) Opt-Out of Unilateral Products. If, at any time,
the non-Opting Out Party elects to Opt-Out of all Unilateral
Products with respect to a Unilateral Target (as defined in the
applicable Unilateral Development and Commercialization Agreement)
pursuant to such Unilateral Development and Commercialization
Agreement and the other Party does not elect to proceed
unilaterally with the research, development and commercialization
of such Unilateral Products, such Unilateral Target shall become a
Collaboration Target and all such Unilateral Products shall become
Dormant Products pursuant to Section 5.3 and the non-Opting
Out Party shall, without any additional consideration, assign * of
its right, title and interest in and to any product Trademark and
all Regulatory Documentation with respect to such Unilateral
Products, including any Regulatory Approvals and applications
therefor (but excluding any Regulatory Documentation comprising
Production Process Technology, including any drug master file), to
the other Party. In the event the Parties elect to proceed jointly
with the research, development and commercialization of such
Dormant Product as a Collaboration Product pursuant to
Section 5.3 or to sublicense such Dormant Product to a Third
Party pursuant to Section 5 (whereupon such Dormant Product
shall become a Collaboration Product), all milestone payments that
were paid by the non-Opting-Out Party to the Opting-Out Party with
respect to such Dormant Product under the applicable Unilateral
Development and Commercialization Agreement shall be refunded by
the Opting-Out Party and the Opting-Out Party shall reimburse the
non-Opting-Out Party for * of its Unilateral Expenses (as defined
in the applicable Unilateral Development and Commercialization
Agreement) in connection with the Exploitation of such Dormant
Product under the applicable Unilateral Development and
Commercialization Agreement.
Section 5.2 Third-Party Development and
Commercialization of Collaboration Products . If both Parties
do not elect to proceed with the development and commercialization
of a Collaboration Product in one or more countries in the
Territory, the Parties shall have the right, at any time, to
license rights to such Collaboration Product to Third Parties in
one or more such countries on such terms and conditions as the
Parties may mutually agree; provided that (a) any such
sublicense with respect to the Medarex Technology shall be governed
by the procedures set forth in Sections 3.3.5 and 3.4 and any such
sublicense with respect to any other Technology of a Party shall be
governed by the procedures set forth in Section 3.4; and
(b) if there is any dispute between the Parties as to whether
or not to grant such a license, no such license shall be
granted
* The asterisk
denotes that 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 and Exchange Commission.
15
and such dispute shall not be
subject to litigation or any other Third Party dispute resolution
mechanism.
Section 5.3 Dormant Products . If both Parties
do not elect to proceed with the development and commercialization
of a particular Collaboration Product with respect to a
Collaboration Target, and the Parties have not licensed rights to
such Collaboration Product to a Third Party pursuant to
Section 5.2 that would be inconsistent therewith, (each such
Collaboration Product with respect to a Collaboration Target may
also be referred to as a “ Dormant Product ”)
either Party shall have the right at any time, subject to
Section 3.3, to bring such Dormant Product to the Steering
Committee to discuss whether to initiate or reinitiate the
research, development or commercialization of such Dormant Product.
The initiating Party shall specify the reasons for proposing to
initiate or reinitiate such research, development or
commercialization. If, within thirty (30) days after the
receipt of such notice, the other Party fails to notify the
interested Party in writing that it wishes to participate in the
research, development or commercialization of such Dormant Product,
then the interested Party shall have the fight to pursue research,
development or commercialization of such Dormant Product as a
Unilateral Product pursuant to Section 5.1, provided that no
Collaboration Product or Unilateral Product with respect to the
same Collaboration Target or Unilateral Target as such Dormant
Product is being Exploited under this Agreement or by the other
Party under a Unilateral Development and Commercialization
Agreement.
ARTICLE 6 -
CONFIDENTIALITY
Section 6.1 Definition “Confidential
Information” of a Party shall mean all information and
know-how and any tangible embodiments thereof provided by or on
behalf of such Party to the other Party either in connection with
the discussions and negotiations pertaining to, or in the course of
performing, this Agreement or the Unilateral Development and
Commercialization Agreements, including the terms of this Agreement
and the Unilateral Development and Commercialization Agreements;
data; knowledge; practices; processes; ideas; research plans;
engineering designs and drawings; research data; manufacturing
processes and techniques; scientific, manufacturing, marketing and
business plans; and financial and personnel matters relating to the
disclosing Party or to its present or future products, sales,
suppliers, customers, employees, investors or business. For
purposes of this Agreement, notwithstanding the Party that
disclosed such information or know-how, all Avalon Know-How and all
information or know-how with respect thereto, shall be Confidential
Information of Avalon and all Medarex know-how, including all
Mice-Related Know-How, and all information and know-how with
respect thereto, shall be Confidential Information of Medarex. For
the avoidance of doubt, Avalon shall be the receiving Party with
respect to the Mice-Related Technology irrespective of the Party
that developed or disclosed such Technology. For purposes of this
Agreement, subject to section 7.1.5, Collaboration Technology, with
respect to confidentiality and non-use obligations of Medarex,
shall be Confidential Information of Avalon, and Medarex shall be
the receiving Party, and, with respect to confidentiality and
non-use obligations of Avalon, shall be Confidential Information of
Medarex, and Avalon shall be the receiving Party.
* The asterisk
denotes that 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 and Exchange Commission.
16
Section 6.2 Exclusions . Notwithstanding the
foregoing, information or know-how of a Party shall not be deemed
Confidential Information with respect to a receiving Party for
purposes of this Agreement, if such information or
know-how:
(a) was already known to the receiving Party or its
Affiliates, other than under an obligation of confidentiality or
non-use, at the time of disclosure to such receiving
Party;
(b) was generally available or known to parties
reasonably skilled in the field to which such information or
know-how pertains, or was otherwise part of the public domain, at
the time of its disclosure to such receiving Party;
(c) became generally available or known to parties
reasonably skilled in the field to which such information or
know-how pertains, or otherwise became part of the public domain,
after its disclosure to such receiving Party through no fault of a
Party other than the party that Controls such information and
know-how;
(d) was disclosed to such receiving Party or its
Affiliates, other than under an obligation of confidentiality or
non-use, by a Third Party who had no obligation to the Party that
Controls such information and know-how not to disclose such
information or know-how to others; or
(e) was independently discovered or developed by such
receiving Party or its Affiliates, as evidenced by their written
records, without the use of Confidential Information belonging to
the Party that Controls such information and know-how, except with
respect to the Mice-Related Know-How, which shall be and remain
Confidential Information of Medarex.
Specific aspects or details of
Confidential Information shall not be deemed to be within the
public domain or in the possession of a Party merely because the
Confidential Information is embraced by more general information in
the public domain or in the possession of such Party. Further, any
combination of Confidential Information shall not be considered in
the public domain or in the possession of a Party merely because
individual elements of such Confidential Information are in the
public domain or in the possession of such Party unless the
combination and its principles are in the public domain or in the
possession of such Party.
Section 6.3 Disclosure and Use Restriction .
Except as expressly provided herein, the Parties agree that, for
the Term and for * thereafter, each Party and its Affiliates and
sublicensees shall keep completely confidential and shall not
publish or otherwise disclose and shill not use for any purpose
except for the purposes contemplated by this Agreement any
Confidential Information of the other Party, its Affiliates or
sublicensees.
Section 6.4 Authorized Disclosure . Each Party
may disclose Confidential Information of the other Party to the
extent that such disclosure is:
6.4.1 Required by Governmental Order . Made in response to a
valid order of a court of competent jurisdiction or other
supra-national, federal, national, regional, state,
* The asterisk
denotes that 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 and Exchange Commission.
17
provincial or local governmental
or regulatory body of competent jurisdiction; provided ,
however , that such Party shall first have given notice to
such other Party and given such other Party a reasonable
opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information and documents that are
the subject of such order be held in confidence by such court or
agency or, if disclosed, be used only for the purposes for which
the order was issued; and provided further that if a
disclosure order is not quashed or a protective order is not
obtained, the Confidential Information disclosed in response to
such court or governmental order shall be limited to that
information which is legally required to be disclosed in response
to such court or governmental order;
6.4.2 Required by Law . Otherwise required by law;
provided , however , that the disclosing Party shall
(a) provide the other Party with reasonable advance notice of
and an opportunity to comment on any such required disclosure,
(b) if requested by such other Party, seek confidential
treatment with respect to any such disclosure to the extent
available, and (c) use good faith efforts to incorporate the
comments of such other Party in any such disclosure or request for
confidential treatment;
6.4.3 Required by Regulatory Authority. Made by such Party
to the Regulatory Authorities as required in connection with any
filing, application or request for Regulatory Approval;
provided , however , that reasonable measures shall
be taken to assure confidential treatment of such
information.
6.4.4 Required by Agreement . Made by such Party, in
connection with the performance of this Agreement to Affiliates,
permitted sublicensees, research parties, employees, consultants,
representatives or agents, each of whom prior to disclosure must be
bound by obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this Article 6;
or
6.4.5 Required by Certain Third Parties . Made by such Party
to existing or potential acquirers or meager candidates; existing
or potential pharmaceutical collaborators (to the extent
contemplated hereunder); investment bankers; existing or potential
investors, venture capital films or other financial institutions or
investors for purposes of obtaining financing; or Affiliates, each
of whom prior to disclosure must be bound by obligations of
confidentiality and non-use at least equivalent in scope to those
set forth in this Article 6. Notwithstanding this Section
6.4.5, Avalon shall not disclose any item of Medarex’s
Confidential Information to any existing or potential acquirer,
merger partner or collaborator that is substantially involved in
the Exploitation of Antibodies or Antibody Products without first
providing Medarex with reasonable advance written notice of each
such disclosure.
Section 6.5 Use of Name . Each Party may use the
name, insignia, symbol, trademark, trade name or logotype of the
other Party only (a) in connection with announcements and
other permitted disclosures relating to this Agreement and the
activities contemplated hereby, (b) as required by Applicable
Law, and (c) otherwise as agreed in writing by such other
Party.
Section 6.6 Press Releases . Press releases or
other similar public communication by either Party relating to this
Agreement, shall be approved in advance by the other Party,
which
* The asterisk
denotes that 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 and Exchange Commission.
18
approval shall tot be
unreasonably withheld or delayed, except for those communications
required by Applicable Law (which shall be provided to the other
Party as soon as practicable after the release or communication
thereof), disclosures of information for which consent has
previously been obtained, and information of a similar nature to
that which has been previously disclosed publicly with respect to
this Agreement, each of which shall not require advance
approval.
Section 6.7 Publications . The parties
acknowledge that scientific lead-time is a key element of the value
of the research and development activities under the Collaboration
and further agree that scientific publications must be strictly
monitored to prevent any adverse effect from premature publication
of results of the research or development activities hereunder. At
least * prior to submission of any material related to the research
or development activities hereunder for publication or
presentation, the submitting Party shall provide to the other Party
a draft of such material for its review and comment. The receiving
party shall provide any comments to the submitting party within *
of receipt of such materials. No publication or presentation with
respect to the research or development activities hereunder shall
be made unless and until the other Party’s comments on the
proposed publication or presentation have been addressed and
changes have been agreed upon and any information determined by the
other Party to be Confidential Information has been removed. If
requested in writing by the other party, the submitting Party shall
withhold material from submission for publication or presentation
for an additional * to allow for the filing of a patent application
or the taking of such measures to establish and preserve
proprietary rights in the information in the material being
submitted for publication or presentation.
ARTICLE 7 -
INTELLECTUAL PROPERTY
Section 7.1 Intellectual Property
Ownership.
7.1.1 Ownership of Medarex Technology . Subject to the
license grants to Avalon under Article 3, as between the Parties,
Medarex shall own and retain all right, title and interest in and
to any and all: (a) Information and Inventions that are
conceived, discovered, developed or otherwise made, by or on behalf
of Medarex (or its Affiliates or its licensees or sublicensees
(other than Avalon and its Affiliates)), whether or not patented or
patentable, and any and all Patent and other intellectual property
rights with respect thereto, except to the extent that any such
Information and Inventions, or any Patent or other intellectual
property rights with respect thereto, are Collaboration Technology;
(b) other Information and inventions, and Patent and other
intellectual property rights that are Controlled (other than
pursuant to the license grants set forth in Article 3) by
Medarex, its Affiliates or its licensees or sublicensees (other
than Avalon and its Affiliates); and (c) other Medarex
Technology.
7.1.2 Ownership of Avalon Technology . Subject to
Section 7.1.3 and, the license grants to Medarex under
Article 3, as between the Parties, Avalon shall own and retain
all right, title and interest in and to any and all:
(a) Information and Inventions that are conceived, discovered,
developed or otherwise made, by or on behalf of Avalon (or its
Affiliates or its licensees or sublicensees (other than Medarex and
its Affiliates)), whether or not patented or
* The asterisk
denotes that 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 and Exchange Commission.
19
patentable, and any and all
Patent and other intellectual property tights with respect thereto,
except to the extent that any such Information and Inventions, or
any Patent or other intellectual property rights with respect
thereto, are Collaboration Technology or Mice Materials or
Mice-Related Technology, (b) other Information and Inventions,
and Patent and other intellectual property rights that are
Controlled (other than pursuant to the license grants set forth in
Article 3) by Avalon, its Affiliates or its licensees or
sublicensees (other than Medarex and its Affiliates); and (c) other
Avalon Technology.
7.1.3 Ownership of Mice-Related Technology. Subject to the
license grants to Avalon under Article 3, as between the
Parties, Medarex shall own and retain all right, title and interest
in and to all Mice Materials and Mice-Related Technology, including
any and all Information and Inventions with respect to the Mice
Materials or the Mice-Related Technology (including any
Improvements thereto) that, as a result of the use of HuMab Mice
provided by Medarex to Avalon under this Agreement, are conceived,
discovered, developed or otherwise made, by or on behalf of Avalon,
its Affiliates or its licensees or sublicensees (other than Medarex
and its Affiliates), whether or not patented or patentable, and any
and all Patent and other intellectual property rights with respect
thereto. Avalon acknowledges and agrees that (a) the licenses
granted to it pursuant to Article 3 permit Avalon to use Mice
Materials and Mice-Related Technology solely for the Exploitation
of Collaboration Products as provided in this Agreement,
(b) Avalon has no right to use the HuMAb Mice or to discover,
develop or otherwise make Improvements with respect to Mice
Materials and Mice-Related Technology under such grants, and (c)
neither it, nor any of its Affiliates, licensees or sublicensees,
will engage, directly or indirectly, in activities deigned to, or
otherwise undertake or attempt, either on behalf of itself or
another, to discover, develop or make any Information and
Inventions that relate to the Mice Materials or the Mice-Related
Technology by use of HuMab Mice provided by Medarex to Avalon under
this Agreement. Accordingly, Avalon shall promptly disclose to
Medarex in writing, the conception or reduction to practice, or the
discovery, development or making of any such Information and
Inventions that relate to the Mice Material or Mice-Related
Technology that results from use of HuMab Mice provided by Medarex
to Avalon under this Agreement and shall, and does hereby, assign,
and shall cause its Affiliates, licensees and sublicensees to so
assign, to Medarex, without additional compensation, all of their
respective rights, titles and interests in and to any such
Information and Inventions.
7.1.4 Ownership of Production Process Technology . Each
Party shall own and retain all right, title and interest in and to
such Party’s Production Process Technology, including any and
all Information and Inventions with respect to such Production
Process Technology (including any Improvements thereto) that are
conceived, discovered, developed or otherwise made, by or on behalf
of such Party, its Affiliates or, to the extent permitted, its
sublicensees, whether or not patented or patentable, and any and
all Patent and other intellectual property rights with respect
thereto. Except as the Parties may otherwise expressly agree,
including by separate written agreement pursuant to
Section 1.2.8 or Section 1.6, neither Party shall have
any rights, express or implied, under this Agreement with respect
to any Production Process Technology of the other Party and nothing
in this Agreement intended to or shall be interpreted as granting a
Party any license to such Production Process Technology, whether
subordinate or dominant to any other Technology.
* The asterisk
denotes that 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 and Exchange Commission.
20
7.1.5 Ownership of Collaboration Technology . Subject to
Sections 7.1.3 and 7.1.4 and the license grants under
Article 3, the Parties shall each own an equal, undivided
interest in any Collaboration Technology; provided ,
however , that, except as otherwise expressly provided in
this Agreement or the Unilateral Development and Commercialization
Agreements, neither a Party nor any of its Affiliates, licensees or
sublicensees shall, directly or indirectly, Exploit any
Collaboration Technology, or any intellectual property rights with
respect thereto, without the written consent of the other Party,
not to be unreasonably withheld or delayed, except that each Party
shall have the right to Exploit such Collaboration Technology for
research and discovery purposes (as opposed to the development,
commercialization or other Exploitation of products or technology
resulting therefrom), and to license others to do so, without the
consent of the other Party; provided , however ,
that, except as expressly provided in the Unilateral Development
and Commercialization Agreements attached hereto, neither Party
shall have the right to use or otherwise Exploit outside the
Collaboration any Collaboration Antibodies, Collaboration Products
or other Mice Materials produced under this Agreement. Each Party
shall promptly disclose to the other Party in writing, and shall
cause its Affiliates, licensees and sublicensees to so disclose,
the development, making, conception or reduction to practice of any
Collaboration Technology, and shall, and does hereby, assign, and
shall cause its Affiliates, licensees and, unless otherwise agreed
by the Parties, sublicensees to so assign, to the other Party,
without additional compensation, such right, title and interest in
and to any collaboration Technology as well as any intellectual
property rights with respect thereto, as is necessary to fully
effect the joint ownership provided for in the foregoing
sentence.
7.1.6 Ownership of Product Trademarks . Subject to the
license grants in Article 3, the Parties shall each own an
equal, undivided interest in each Product Trademark with respect to
a Collaboration Product. In the event that a Party Opts-Out with
respect to a Collaboration Product, it shall, without any
additional consideration, assign all of its right, title and
interest in and to any Product Trademark with respect to such
collaboration Product or Unilateral Product to the non-Opting-Out
Party; provided , however , that each Party shall
retain all of its right, title and interest in and to any Product
Trademarks with respect to Dormant Products.
7.1.7 Ownership of Regulatory Documentation.
(a) Subject to the license grants in Article 3,
each Regulatory Approval with respect to a Collaboration Product
shall be owned by one of the Parties, with such ownership being
determined by the Steering Committee based on the activities of the
Parties with respect to such Collaboration Product. The Steering
Committee shall make such determination on a county-by-country
basis, based on which Party will be better able to obtain and
maintain such Regulatory Approval and satisfy its regulatory
obligations with respect to such ownership in such country,
including, for example, to promptly respond to queries of, and file
reports with, the applicable Regulatory Authority with respect to
such Regulatory Approval in such country. Factors to be considered
in making such determination shall include whether a Party is
performing activities that would give rise to reporting obligations
under such Regulatory Approval (e.g., clinical studies under an IND
or marketing under a BLA), whether a Party performed activities
that support such Regulatory Approval (e.g., pre-clinical studies
with respect to an IND or clinical studies with respect to a BLA),
whether a Party has particular
*The asterisk
denotes that 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 and Exchange Commission.
21
experience with Antibody Products
or the indication in question, whether a Party has experience with
the Regulatory Authorities in a country, particularly with respect
to the activities involved, and whether a party has appropriate
regulatory personnel in a country. Notwithstanding the Party that
owns a Regulatory Approval, the Parties shall cooperate in
satisfying their obligations under such Regulatory Approval,
including by promptly exchanging information, such as adverse event
data, so as to enable the owner to make reports to, and respond to
requests of, the Regulatory Authorities and perform its other
obligations under such Regulatory Approval.
(b) Subject to the license grants in Article 3,
each Party shall, to the extent permitted by law, have an equal,
undivided interest in all other Regulatory Documentation. Subject
to the foregoing sentence, each Party shall promptly
(i) disclose to the other Party in writing, and shall cause
its Affiliates, licensees and sublicensees to so disclose, such
other Regulatory Documentation, and (ii) assign, or cause its
Affiliates, licensees or sublicensees to assign, to the other
party, without additional compensation, such right, title and
interest in and in such other Regulatory Documentation as is
necessary to fully effect the joint ownership provided for in the
foregoing sentence. Each non-Opting-Out Party shall have the right
to own all right, title and interest in and to all Regulatory
Approvals with respect to its Unilateral Products. In the event
that a Party Opts-Out with respect to a Collaboration Product, it
shall assign all of its right, title and interest in and to all
Regulatory Documentation with respect to such Collaboration
Product, including any Regulatory Approvals and applications
therefor, to the non-Opting Out Party (or its designee);
provided , however , that each Party shall retain any
of its right, title and interest in and to any Regulatory
Documentation with respect to a Dormant Product.
(c) Notwithstanding the ownership of any regulatory
Approval or any other Regulatory Documentation, neither a Party nor
any of its Affiliates, licensees or sublicensees shall, directly or
indirectly, transfer or use any regulatory Documentation without
the written consent of the other Party, not to be unreasonably
withheld OT delayed; provided, however, that each Party shall have
the right to use and reference any of the Regulatory Documentation
in connection with the Exploitation of Collaboration Products as
provided in this Agreement or Unilateral Products as provided in
any Unilateral Development and Commercialization Agreement.
Notwithstanding the foregoing, any regulatory Documentation
containing Production Process Know-How of a Party shall be and
remain the sole and exclusive property of such Party and such Party
shall have the right to submit any such Production Process Know-How
directly to the Regulatory Authorities using a drug master file, or
any foreign equivalent that is designed to protect such
Party’s Confidential Information, which filing shall be and
remain the sole and exclusive property of such Party.
7.1.8 United States, Law . The determination of whether
Information and Inventions are conceived, discovered, developed or
otherwise made by a Party for the purpose of allocating proprietary
rights (including Patent, copyright or other intellectual property
rights) therein, shall, for purposes of this Agreement, be made in
accordance with applicable United States law.
Section 7.2 Prosecution of Patents and
Trademarks.
* The asterisk denotes that
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 and Exchange Commission.
22
7.2.1 Medarex Rights . As between the Parties, Medarex
shall, subject to Section 7.2.5, have the sole right, at its
cost and expense, to obtain, prosecute and maintain throughout the
world the Medarex Patents, including the Mice-Related Patents and
its Production Process Patents.
7.2.2 Avalon Rights . As between the Parties, Avalon shall,
subject to Section 7.2.5, have the sole right, at its cost and
expense, to obtain, prosecute and maintain throughout the world the
Avalon Patents, including its Production Process
Patents.
7.2.3 Collaboration Technology and Product
Trademarks.
(a) Filings of Patents. The Steering Committee shall
formulate a strategy for the filing, prosecution and maintenance of
Collaboration Patents. Subject to Section 7.2.6, the Parties
shall, and shall cause their respective Affiliates, licensees and
sublicensees, as applicable, to, cooperate with one another with
respect to the filing, prosecution and maintenance of all
Collaboration Patents, including by selecting outside counsel,
reasonably acceptable to the parties, to handle such filing,
prosecution and maintenance. The Steering Committee shall establish
a process under which each Party shall have a reasonable
opportunity to review and comment upon drafts of each new
application for a Collaboration Patent and all substantive
correspondence to or from any patent authority with respect
thereto, prior to the filing of such application or correspondence.
The Parties shall share equally in the expenses associated with the
filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of all
Collaboration Patents.
(b) Filings of Product Trademarks. The Steering
Committee, with respect to a Collaboration Product, shall supervise
and direct the filing, prosecution and maintenance of the
registrations of the Product Trademarks for such Collaboration
Product. The Steering Committee shall provide each party with
(i) drafts of any new application to register a Product
Trademark prior to filing that application, allowing adequate time
for review and comment by the Parties if possible; provided
, however , the Steering Committee shall not be obligated to
delay the filing of any application; and (ii) copies of all
correspondence from any and all Trademark offices concerning
Product Trademark registrations and an opportunity to comment on
any proposed responses, voluntary amendments and submissions of any
kind to be made to any and all such Trademark offices. Subject to
Section 7.2.6, the Parties shall share equally in the expenses
associated with the filing, prosecution and maintenance of such
Product Trademark registrations.
7.2.4 Cooperation . Each party shall., and shall cause its
Affiliates, licensees and sublicensees, as applicable, to,
cooperate fully in the preparation, filing, prosecution, and
maintenance of the Product Trademarks and, if requested by the
other Party, such other Party’s Patents, provided that such
other party shall reimburse the cooperating Party for its
reasonable out-of-pocket expenses incurred in connection with such
requested cooperation. Such cooperation includes (a) promptly
executing all papers and instruments and requiring employees to
execute such papers and instruments as reasonable and appropriate
so as to enable such other Party or the Steering Committee, as
applicable, to file, prosecute, and maintain its Patents in
any
* The asterisk denotes that
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 and Exchange Commission.
23
country; and (b) promptly
informing such other Party of matters that may affect the
preparation, filing, prosecution, or maintenance of any such
Patents.
7.2.5 Patent Filings . Avalon covenants not to, and to cause
its Affiliates, licensees and sublicensees, as applicable, not to,
file any patent application disclosing or claiming any Information
and Inventions comprising any Medarex Technology or the
Exploitation thereof, without Medarex’s prior written
consent, which consent shall not be unreasonably withheld or
delayed. Medarex covenants not to, and to cause its Affiliates,
licensees and sublicensees, as applicable, not to, file any patent
application disclosing or claiming any Information and Inventions
comprising any Avalon Technology or the Exploitation thereof,
without Avalon’s prior written consent, which consent shall
not be unreasonably withheld or delayed.
7.2.6 Election Not to Prosecute . If a Party elects not
(a) to pursue the filing, prosecution or maintenance of a
Collaboration Patent in a particular country, (b) to pursue
the registration, prosecution or maintenance of a Product Trademark
in a particular country, or (c) to take any other action with
respect to Collaboration Technology or a Product Trademark in a
particular country that is necessary or reasonably useful to
establish or preserve rights thereto, then in each such case such
Party shall so notify the other Party promptly in writing and in
good time to enable such other Party to meet any deadlines by which
an action must be taken to establish or preserve any such rights in
such Collaboration Technology or Product Trademark, as applicable,
in such country. Upon receipt of each such notice by such other
Party or if, at any time, such Party fails to initiate any such
action within * after a request by such other Party that it do so
(or thereafter diligently pursue such action), such other Party
shall have the right, but not the obligation, to pursue the filing
or registration, or support the continued prosecution or
maintenance, of such Patent or Product Trademark, as applicable, at
its expense in such country. If such other Party elects to pursue
such filing or registration, as the case may be, or continue such
support, then such other Party shall notify such Party of such
election and such Party shall, and shall cause its Affiliates,
licensees and sublicensees, as applicable, to, (x) reasonably
cooperate with such other Party in this regard, and
(y) subject to Article 3, promptly release or assign to
such other Party, without compensation, all right, title and
interest in and to such Collaboration Patent or Product, Trademark,
as applicable, in such country.
Section 7.3 Enforcement ,of Patents and
Trademarks.
7.3.1 Rights and Procedures . If Medarex or Avalon
determines that any Technology or Product Trademark is being
infringed by a Third Party’s activities and that such
infringement could affect the exercise by the Parties of their
respective rights and obligations under this Agreement, it shall
promptly notify the other Party in writing and provide such other
Party with any evidence of such infringement that is reasonably
available. Promptly after the receipt of such written notice, the
Parties shall meet and discuss in good faith the removal of such
infringement. The pursuing Party shall consider in good faith any
comments from the other Party and shall keep the other Party
reasonably informed of any steps taken to remove such
infringement.
* The asterisk denotes that
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 and Exchange Commission.
24
(a) Collaboration Technology and Product Trademarks.
With respect to Collaboration Technology and Product Trademarks,
the Steering Committee shall have the first right to remove such
infringement * , including the filing of an infringement suit or
taking other similar action * . In the event the Steering Committee
fails to * to remove any infringement of any such Collaboration
Technology or Product Trademark within * following notice of such
infringement, or earlier notifies the Parties in writing of its
intent not to take such steps, and (i) such failure to act is
due to the refusal of one Party’s representatives on the
Steering Committee to authorize action over the objection of the
other Party’s representatives, then the Party whose
representatives wish to proceed shall have the right to do so at
its expense, or (ii) such failure to act is due to any reason
other than as set forth in clause (i) above, then either Party
shall have the right to proceed at its expense; provided ,
however , that if the Steering Committee has commenced
negotiations with an alleged infringer for discontinuance of such
infringement within such * period, the Steering Committee shall
have an additional * to conclude its negotiations before a Party
unilaterally may bring suit for such infringement.
(b) Other Technology. With respect to Technology of a
Party that is not Collaboration Technology, the owner of such
Technology shall have the sole right, but not the obligation, to
remove such infringement; provided , however , that
if the other Party agrees in writing to the removal of such
infringement, the other Party shall reimburse the owner of such
Technology * incurred by such owner with respect to the removal of
any such infringement.
7.3.2 Cooperation . The Party not enforcing the applicable
Technology or Product Trademark shall provide seasonable assistance
to the other Party, including providing access to relevant
documents and other evidence, making its employees available at
reasonable business hours, and joining the action to the extent
necessary to allow the enforcing Party to maintain the
action.
7.3.3 Recovery . Any amounts recovered by a Party in an
enforcement pursuant to Section 7.3.1, whether by settlement
or judgment, shall be used to reimburse the Parties for their
reasonable costs and expenses in making such recovery (which amount
shall be allocated pro rata if insufficient to cover the totality
of such expenses), with any remainder being retained by the Party
that has exercised its right to bring the enforcement action unless
such enforcement action was jointly funded by the Parties pursuant
to Section 7.3.1, in which case such remainder shall be shared
by the Parties, to the extent that such enforcement was jointly
funded.
Section 7.4
Potential Third-Party
Rights.
7.4.1 Third-Party Licenses . If either Party becomes aware
of any Patents issued to a Third Party, which may be necessary or
useful to practice in exploiting a Collaboration Product, such
Party shall discuss such matter with the other Party. The Parties,
through the Steering Committee, shall determine in good faith
whether to seek a license under such Patents for such Exploitation.
Further, if (a) in the Collective Opinion of Counsel, a Party,
or any of its Affiliates, licensees or permitted sublicensees,
cannot Exploit a Collaboration Product in a country in the
Territory without infringing one or more Patents that have issued
to a Third Party in such country, or (b) as a result of any
claim made against a Party, or any of its Affiliates, licensees or
permitted sublicensees, alleging that the Exploitation of a
Collaboration
* The asterisk
denotes that 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 and Exchange Commission.
25
Product infringes or
misappropriates any Patent or any other intellectual property right
of a Third Party in a country in the Territory, a judgment is
entered by a court of competent jurisdiction from which no appeal
is taken within the time permitted for appeal, such that a Party
cannot Exploit such Collaboration Product in such country without
infringing the Patent or other proprietary rights of such Third
Party, then, in either case, the Parties shall * to obtain a
license in the names of the Parties from such Third Party as
necessary for the Exploitation of any Collaboration Products
hereunder in such country; provided , however , that
Medarex shall have the sole right to seek any such license with
respect to Mice-Related Technology and shall * to obtain such a
license in its own name from such Third Party in such country,
under which Medarex shall, to the extent permissible under such
license, grant a sublicense to Avalon as necessary for Avalon, and
any of its Affiliates and permitted sublicensees, to Exploit the
Collaboration Products as provided hereunder in such country. * of
any royalty or other obligations under such licenses, except with
respect to the Medarex Technology or the Avalon Technology, * . For
purposes of this Section 7.4.1, “ Collective Opinion
of Counsel ” shall mean the final joint opinion of patent
counsel selected by Avalon and patent counsel selected by Medarex,
after review of all data and information reasonably available at
the time such opinion is rendered. If patent counsel for the
Parties cannot agree on a final joint opinion within * after
submission of the matter to such counsel, the patent counsel of the
Parties shall agree on a third patent counsel who shall offer an
independent opinion on the subject matter, which independent
opinion shall be deemed the Collective Opinion of
Counsel.
7.4.2 Third-Party Litigation . In the event that a Third
Party institutes a Patent, Trademark, or other infringement suit
(including any suit claiming confusion, deception or dilution of a
Trademark by a Product Trademark) against either Party or its
respective Affiliates, licensees or permitted sublicensees during
the Term, alleging that the Exploitation of the Collaboration
Products in the Territory or any other activities hereunder,
infringes one or more Patent, Trademark or other intellectual
property rights held by such Third party (an “
Infringement Suit ’”‘), the Parties shall
cooperate with one another in defending such suit. The Parties,
through the Steering Committee, shall jointly direct and control
the defense of any Infringement Suit with respect to Collaboration
Products or any other activity of the Parties under this Agreement.
* .
7.4.3 Retained Rights . Nothing in this Section 7.4
shall prevent either Party, at its own expense, from obtaining any
license or other rights from Third Parties it deems appropriate in
order to permit the full and unhindered exercise of its rights
under this Agreement.
Section 7.5 Invalidity or Unenforceability Defenses
or Actions.
7.5.1 Defense or Counterclaims. In the event that a Third
Party asserts, as a defense or as a counterclaim in any
infringement action under *, * then the Parties shall * . The Party
or Parties that are the plaintiffs in the underlying suit or action
against such Third Party shall *.
7.5.2 Declaratory Judgment Action . Similarly, if a Third
Party asserts, in a declaratory judgment action or similar action
or claim filed by such Third Party based upon * , then the Parties
shall * . The Party that is the defendant in such claim, suit or
action shall * .
* The asterisk
denotes that 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 and Exchange Commission.
26
7.5.3 Mice-Related Technology . * .
7.5.4 Costs and Expenses . * . With respect to the Medarex
Technology (including the Mice-Related Technology) or the Avalon
Technology, * .
Section 7.6 Exchange of Know-How.
7.6.1 Information Disclosure . Each Party shall, and shall
cause its Affiliates, licensees and sublicensees, as applicable,
to, without additional compensation and at such Party’s sole
expense, disclose and make available to the other Party, in
whatever form each such other Party may reasonably request, all
Regulatory Documentation, all of its other Know-How, all
Information and Inventions included in the Collaboration Technology
and any other Information and Inventions relating, directly or
indirectly, to the Exploitation of any Collaboration Products
immediately after an Antigen becomes a Collaboration Target and
thereafter immediately upon the earlier of the conception or
reduction to practice, discovery, development or making of each
such Regulatory Documentation, Know-How, or other such Information
and Inventions
7.6.2 Cooperation . With respect to the research,
development, commercialization or other Exploitation of the
Collaboration Products, each Party, shall cooperate with any and
all reasonable requests for assistance from the other Party,
including by making its employees, consultants and other scientific
staff available upon reasonable notice during normal business hours
at their respective places of business to consult with such other
Party, as applicable, on issues arising during such research,
development, commercialization or Exploitation.
7.6.3 Biological Materials . For purposes of facilitating
the conduct of the research and development activities under this
Agreement, Medarex and Avalon shall each provide to the other
tissues, cells, cell lines, organisms, blood samples, genetic
material, and other biological substances and materials, including
the Mice Materials, the Collaboration Targets and other Antigens
(collectively, “ Biological Materials ”)
specified from time to time in this Agreement or the applicable
Project Plan. Each Party agrees to provide all such Biological
Materials to the other in accordance with this Agreement and the
applicable Project Plan, and under the supervision of the Steering
Committee. The Parties agree that: (a) all Biological
Materials provided by one Party to the other Party and any
Biological Material (including Collaboration Products and other
Mice Materials) produced against or with, or derived from, such
Biological Materials shall be used solely for the research and
development activities as provided in the Project Plan, and in
material compliance with all Applicable Law; (b) all such
Biological Materials shall be provided without any warranties,
express or implied; (c) the Party providing such Biological
Materials shall obtain (or cause its Third Party collaborators to
obtain or certify that they have obtained) all appropriate and
required consents from the source of such Biological Materials;
(d) Biological Materials provided by one Party to the other
Party (other than Collaboration Products) shall not be made
available by such other Party to any Third Party except as
expressly provided (i) in the Project Plan or (ii) in the
applicable Unilateral Development and Commercialization Agreement,
unless the prior written consent of the Party providing such
Biological Materials is first obtained; and (e) subject to the
license grants in
* The asterisk
denotes that 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 and Exchange Commission.
27
Article 3, all right, title
and interest in and to the Mice Materials and the Mice-Related
Technology shall be, and remain, vested in Medarex.
7.6.4 Regulatory Records . With respect to the subject
matter of this Agreement, each Party shall maintain, or cause to be
maintained, records of its respective research, development,
manufacturing and commercialization activities, including all
Regulatory Documentation, in sufficient detail and in good
scientific manner appropriate for patent and regulatory purposes,
which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of
such activities, and which shall be retained during the Term and
for a period of five (5) years thereafter, or for such longer
period as may be required by Applicable Law. Each Party shall have
the right, during normal business hours and upon reasonable notice,
to inspect and copy any such records, except (a) with respect
to Medarex’s records, to the extent that such records contain
proprietary information with respect to the Mice Materials and
Mice-Related Technology, or (b) with respect to a
Party’s records, to the extent that such records contain
proprietary information with respect to its Production Process
Technology.
7.6.5 Production Process Technology . Notwithstanding
anything to the contrary in this Section 7.6 or elsewhere in this
Agreement, neither Party shall be obligated to disclose or provide
any of its Production Process Technology, including Biological
Materials with respect thereto, to the other Party or any Third
Party except as may be required or permitted under a separate
written agreement entered into by the Parties pursuant to
Section 1.2.8 or Section 1.6.
ARTICLE 8 -
TERM AND TERMINATION
Section 8.1 Term . The term of this Agreement
(the “ Term ”) shall commence upon the Effective
Date and shall continue in effect until the later of (a) the
first anniversary of the completion of all of the activities in
Section 1.2, or (b) such time as there is no longer any
(i) Dormant Product with respect to which the Parties have
rights pursuant to Section 5.3, or (ii) Collaboration Product
being Exploited hereunder, whether pursuant to Section 1.7 or
otherwise, or any Unilateral Product being Exploited under a
Unilateral Development and Commercialization Agreement, unless this
Agreement is terminated at an earlier date in accordance with the
terms and conditions set forth in this Article 8.
Section 8.2 Termination for Material Breach .
Any material failure by a Party to comply with any of its material
obligations contained herein shall entitle the Party not in default
to give to the Party in default written notice specifying the
nature of the default, requiring the defaulting Party to make good
or otherwise cure such default, and stating its intention if such
default is not cured to terminate or, at the option of the Party
not in default, to convert a Collaboration Product to which the
material breach applies to a Unilateral Product pursuant to
Section 5.1. If such default is not cured within * after the
receipt of such notice (or, if such default cannot be cured within
such * , if the Party in default does not commence actions to cure
such default within such period and thereafter diligently continue
such actions or if such default is not otherwise cured within *
after the receipt of such notice), except in the case of
a
* The asterisk
denotes that 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 and Exchange Commission.
28
payment default, as to which the
defaulting Party shall have only a * cure period, the Party not in
default shall be entitled, on written notice to the other Party,
without prejudice to any of its other rights conferred on it by
this Agreement, and in addition to any other remedies available to
it by law or in equity, to (a) terminate this Agreement in its
entirety, or (b) convert such Collaboration Product to a
Unilateral Product pursuant to Section 5.1, whereupon the
defaulting Party shall be deemed the Opting-Out Party with respect
to such Unilateral Product for all purposes hereunder and the
notice provided under this provision shall be deemed equivalent to
an Election Notice as provided in Section 5.1.
Section 8.3 Termination Upon Insolvency . Either
Party may terminate this Agreement if, at any time, the other Party
shall file in any court or agency pursuant to any statute or
regulation of any state, country or jurisdiction, a petition in
bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of that
Party or of its assets, or if such other Party proposes a written
agreement of composition or extension of its debts, or if such
other Party shall be served with an involuntary petition against
it, filed in any insolvency proceeding, and such petition shall not
be dismissed within * after the filing thereof, or if such other
Party shall propose or be a party to any dissolution or
liquidation, or if such other Party shall make an assignment for
the benefit of its creditors.
Section 8.4 Rights in Bankruptcy . All rights
and licenses granted under or pursuant to this Agreement by Medarex
or Avalon are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the United States Bankruptcy Code, licenses of
rights to “intellectual property” as defined under
Section 101 of the United States Bankruptcy Code. The Parties
agree that the Parties, as licensees of such rights under this
Agreement, shall retain and may fully exercise all of their rights
and elections under the United States Bankruptcy Code. The Parties
further agree that, in the event of the commencement of a
bankruptcy proceeding by or against a Party under the United States
Bankruptcy Code, the Party hereto that is not a party to such
proceeding shall be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property
and all embodiments of such intellectual property, which, if not
already in the non-subject Party’s possession, shall be
promptly delivered to it (a) upon any such commencement of a
bankruptcy proceeding upon the non-subject Party’s written
request therefor, unless the Party subject to such proceeding
continues to perform all of its obligations under this Agreement or
(b) if not delivered under clause (a) above, following the
rejection of this Agreement by or on behalf of the Party subject to
such proceeding upon written request therefor by the non-subject
Party.
Section 8.5 Consequences of Expiration or
Termination.
8.5.1 Licenses . Upon expiration of the Term in accordance
with Section 8.1 and payment of all amounts owed pursuant to
Section 4.1, the licenses granted by Medarex to Avalon, and by
Avalon to Medarex, hereunder shall become fully-paid up.
8.5.2 Return of Information and Materials . Upon expiration
of this Agreement pursuant to Section 8.1, or upon termination
of this Agreement in its entirety by either Party pursuant to this
Article 8, each Party, at the request of the other Party,
shall return Biological Materials of such other Party and all data,
files, records and other materials in its
* The asterisk
denotes that 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 and Exchange Commission.
29
possession or control relating to
such other Party’s Technology, or containing or comprising
such other Party’s Information and Inventions or other
Confidential Information (other than Collaboration Technology) and,
in each case, to which the returning Party does not retain rights
hereunder (except one copy of which (other than Biological
Materials) may be retained solely for archival
purposes).
Section 8.6 Accrued Rights; Surviving
Obligations.
8.6.1 Accrued Rights . Termination or expiration of this
Agreement for any reason shall be without prejudice to any rights
that shall have accrued to the benefit of a Party prior to such
termination or expiration. Such termination or expiration shall not
relieve a Party from obligations that are expressly indicated to
survive the termination or expiration of this Agreement.
8.6.2 Survival . Articles 4 (with respect to obligations
arising prior to expiration or termination), 6 and 9, and
Sections 1.2.4 (with respect to obligations arising prior to
the expiration or termination of this Agreement), 1.7, 3.3.3,
3.3.5, 3.4 (with respect only to the last sentence thereof), 3.5,
4.5, 7.1, 7.2, 7.6.3 (with respect only to the last sentence
thereof), 7.6.4, 7.6.5, 8.5, 10.5, 11.5 and 11.6 and Appendices A
and B of this Agreement and this Section 8.6 shall survive
expiration or termination of this Agreement for any
reason.
ARTICLE 9 -
INDEMNIFICATION AND INSURANCE
Section 9.1 Indemnification of Medarex . Avalon
shall indemnify Medarex, its Affiliates and their respective
directors, officers, employees and agents, and defend and save each
of them harmless, from and against any and all losses, damages,
liabilities, costs and expenses (including reasonable
attorneys’ fees and expenses) (collectively, “
Losses ”) in connection with any and all Third-Party
suits, investigations, claims or demands (collectively, “
Third-Party Claims ”) arising from or occurring as a
result of (a) the negligence (except to the extent that such
Loss is covered by one or more liability insurance policies of the
indemnified person or entity) or willful misconduct on the part of
Avalon or its Affiliates, licensees or sublicensees under this
Agreement (other than Medarex and its Affiliates and any Third
Parties to whom the Parties license rights with respect to a
Collaboration Product pursuant to Section 5.2) in performing
any activity contemplated by this Agreement, except for those
Losses for which Medarex has an obligation to indemnify Avalon and
its Affiliates pursuant to Section 9.2, as to which Losses
each Party shall indemnify the other to the extent of their
respective liability for the Losses.
Section 9.2 Indemnification of Avalon . Medarex
shall indemnify Avalon, its Affiliates and their respective
directors, officers, employees and agents, and defend and save each
of them harmless, from and against any and all Losses in connection
with any and all Third-Party Claims arising from or occurring as a
result of the negligence (except to the extent that such Loss is
covered by one or more liability insurance policies of the
indemnified person or entity) or willful misconduct on the part of
Medarex or its Affiliates, licensees or sublicensees under this
Agreement (other than Avalon and its Affiliates and any Third
Parties to whom the
* The asterisk
denotes that 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 and Exchange Commission.
30
Parties license rights with
respect to a Collaboration Product pursuant to Section 5.2) in
performing any activity contemplated by this Agreement, except for
those Losses for which Avalon has an obligation to indemnify
Medarex and its Affiliates pursuant to Section 9.1, as to
which Losses each party shall indemnify the other to the extent of
their respective liability for the Losses.
Section 9.3 Product Liability . Except as
provided under Section 9.1 or Section 9.2, all Losses
arising from or occurring as a result of any Third-Party Claim for
product liability or personal injury that are not covered by one or
mare insurance policies that were purchased jointly by the Parties
shall * .
Section 9.4 Indemnification
Procedure.
9.4.1 Notice of Claim . The indemnified Party shall give the
indemnifying Party prompt written notice (an “
Indemnification Claim Notice ”) of any Losses or
discovery of fact upon which such indemnified Party intends to base
a request for indemnification under Section 9.1 or
Section 9.2, but in no event shall the indemnifying Party be
liable for any Losses that result from any delay in providing such
notice. Each Indemnification Claim notice must contain a
description of the claim and the nature and amount of such Loss (to
the extent that the nature and amount of such Loss are known at
such time). The indemnified Party shall furnish promptly to the
indemnifying Party copies of all papers and official documents
received in respect of any Losses. All indemnification claims in
respect of a Party, its Affiliates or their respective directors,
officers, employees and agents (collectively, the “
Indemnitees ” and each an “ Indemnitee
”) shall be made solely by such Party to this Agreement (the
“ Indemnified Party ”).
9.4.2 Control of Defense . At its option, the indemnifying
Party may assume the defense of any Third-Party Claim by giving
written notice to the Indemnified Party within * after the
indemnifying Party’s receipt of an Indemnification Claim
Notice. The assumption of the defense of a Third-Party Claim by the
indemnifying Party shall not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify any Indemnitee in
respect of the Third-Party Claim, nor shall it constitute a waiver
by the indemnifying Party of any defenses it may assert against any
Indemnitee’s claim for indemnification. Upon assuming the
defense of a Third-Party Claim, the indemnifying Party may appoint
as lead counsel in the defense of the Third-Party Claim any legal
counsel selected by the indemnifying Party. In the event the
indemnifying Party assumes the defense of a Third-Party Claim, the
Indemnified Party shall immediately deliver to the indemnifying
Party all original notices and documents (including court papers)
received by any Indemnitee in connection with the Third-Party
Claim. Should the indemnifying Party assume the defense of a
Third-Party Claim, the indemnifying Party shall not be liable to
the Indemnified Party or any other Indemnitee for any legal
expenses subsequently incurred by such Indemnified Party or other
Indemnitee in connection with the analysis, defense or settlement
of the Third-Party Claim. In the event that it is ultimately
determined that the indemnifying Party is not obligated to
indemnify, defend or hold harmless an Indemnitee from and against
the Third-Party Claim, the Indemnified Party shall reimburse the
indemnifying Party for any and all costs and expenses (including
attorneys’ fees and costs of suit) and any Losses incurred by
the indemnifying Party in its defense of the Third-Party Claim with
respect to such Indemnitee.
* The asterisk
denotes that 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 and Exchange Commission.
31
9.4.3 Right to Participate in Defense . Without limiting
Section 9.4.2, any Indemnitee shall be entitled to participate
in, but not control, the defense of such Third-Party Claim and to
engage counsel of its choice for such purpose; provided ,
however , that such engagement shall be at the
Indemnitee’s own expense unless (a) the engagement
thereof has been specifically authorized by the indemnifying Party
in writing, or (b) the indemnifying Party has failed to assume
the defense and engage counsel in accordance with
Section 9.4.2 (in which case the Indemnified Party shall
control the defense).
9.4.4 Settlement . With respect to any Losses relating
solely to the payment of money damages in connection with a
Third-Party Claim and as to which the indemnifying Party shall have
acknowledged in writing the obligation to indemnify the Indemnitee
hereunder, the indemnifying Party shall have the sole right to
consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss, on such terms as the indemnifying
Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Third-Party Claims, where
the indemnifying Party has assumed the defense of the Third-Party
Claim in accordance with Section 9.4.2, the indemnifying Party
shall have authority to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss provided it
obtains the prior written consent of the Indemnified Party (which
consent shall not be unreasonably withheld or delayed). The
indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnitee that is reached without the
written consent of the indemnifying Party. Regardless of whether
the indemnifying Party chooses to defend or prosecute any
Third-Party Claim, no Indemnitee shall admit any liability with
respect to, or settle, compromise or discharge, any Third-Party
Claim without the prior written consent of the indemnifying
Party.
9.4.5 Cooperation . Regardless of whether the indemnifying
Party chooses to defend or prosecute any Third-Party Claim, the
Indemnified Party shall, and shall cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and shall furnish
such records, information and testimony, provide such witnesses and
attend such conferences, discovery proceedings, hearings, trials
and appeals as may be reasonably requested in connection therewith.
Such cooperation shall include access during normal business hours
afforded to the indemnifying Party to, and reasonable retention by
the Indemnified Party of, records and information that are
reasonably relevant to such Third-Party Claim, and making
Indemnitees and other employees and agents available on a mutually
convenient basis to provide additional information and explanation
of any material provided hereunder, and the indemnifying Party
shall reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
9.4.6 Expenses . Except as provided above, the reasonable
and verifiable costs and expenses, including fees and disbursements
of counsel, incurred by the Indemnified Party in connection with
any claim shall be reimbursed * basis by the indemnifying Party,
without prejudice to the indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and
subject to refund in the event the Indemnifying Party is ultimately
held not to be obligated to indemnify the Indemnified
Party.
* The asterisk
denotes that 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 and Exchange Commission.
32
Section 9.5 Insurance . Each Party shall have
and maintain such types and amounts of liability insurance as is
normal and customary in the industry generally for parties
similarly situated, and shall upon request provide the other Party
with a copy of its policies of insurance in that regard, along with
any amendments and revisions thereto.
ARTICLE 10 -
REPRESENTATIONS, WARRANTIES AND COVENANTS
Section 10.1 Representations, Warranties and
Covenants . Each Party hereby represents, warrants and
covenants to the other Party as of the Effective Date as
follows:
10.1.1 Corporate Authority . Such Party (a) has the
power and authority and the legal right to enter into this
Agreement and the Unilateral Development and Commercialization
Agreements and to perform its obligations hereunder and thereunder,
and (b) has taken all necessary action on its part required to
authorize the execution and delivery of this Agreement and the
Unilateral Development and Commercialization Agreements and the
performance of its obligations hereunder and thereunder. This
Agreement and the Unilateral Development and Commercialization
Agreements have been duly executed and delivered on behalf of such
Party and constitute legal, valid and binding obligations of such
Party and are enforceable against it in accordance with their
respective terms subject to the effects of bankruptcy, insolvency
or other laws of general application affecting the enforcement of
creditor rights and judicial principles affecting the availability
of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or
equity.
10.1.2 Litigation . Such Party is not aware of any pending
or threatened litigation (and has not received any communication)
that alleges (i) that such Party’s activities related to
this Agreement or the Unilateral Development and Commercialization
Agreements have violated, or (ii) that by conducting the activities
as contemplated herein or therein such Party would violate, any of
the intellectual property rights of any other party.
10.1.3 Consents, Approvals, etc. All necessary consents,
approvals and authorizations of all Regulatory Authorities and
other parties required to be obtained by such Party in connection
with the execution and delivery of this Agreement and the
Unilateral Development and Commercialization Agreements and the
performance of its obligations hereunder and thereunder have been
obtained.
10.1.4 Conflicts . The execution and delivery of this
Agreement and the Unilateral Development and Commercialization
Agreements and the performance of such Party’s obligations
hereunder and thereunder (a) do not conflict with or violate
any requirement of Applicable Law or any provision of the articles
of incorporation, bylaws or any similar instrument of such Party,
as applicable, in any material way, and (b) do not conflict
with, violate, or breach or constitute a default or require any
consent under, any contractual obligation or court or
administrative order by which such Party is bound.
10.1.5 Debarment . No such Party nor any of its Affiliates
has been debarred or is subject to debarment and neither such Party
nor any of its Affiliates will use in any capacity, in connection
with the services to be performed under this Agreement or the
Unilateral
* The asterisk
denotes that 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 and Exchange Commission.
33
Development and Commercialization
Agreements, any party who has been debarred pursuant to
Section 306 of the Federal Food, Drug, and Cosmetic Act, as
amended, or who is the subject of a conviction described in such
section. Each Party will inform the other Party in writing
immediately if it or any party who is performing services hereunder
is debarred or is the subject of a conviction described in
Section 306, or if any action, suit, claim, investigation or
legal or administrative proceeding is pending or, to such
Party’s knowledge, is threatened, relating to the debarment
or conviction of such Party or any party performing services
hereunder or thereunder.
Section 10.2 Additional Representations and
Warranties of Medarex . Medarex represents and warrants to
Avalon that Medarex is a corporation duly organized, validly
existing and in good standing under the laws of the State of New
Jersey, and has full corporate power and authority and the legal
right to own and operate its property and assets and to carry on
its business as it is now being conducted and as it is contemplated
to be conducted by this Agreement and the Unilateral Development
and Commercialization Agreements.
Section 10.3 Additional Representations, Warranties
and Covenant of Avalon.
10.3.1 Avalon represents and warrants to Medarex that Avalon
is a corporation duly organized, validly existing and in good
standing under the laws of Delaware, and has full corporate power
and authority and the legal right to own and operate its property
and assets and to carry on its business as it is now being
conducted and as it is contemplated to be conducted by this
Agreement and the Unilateral Development and Commercialization
Agreements. Avalon, as a sublicensee under the MRC Agreement, shall
comply with all the terms and conditions of the MRC Agreement that
are applicable to a sublicensee under such agreement.
10.3.2 Avalon represents and warrants to Medarex that,
except as set forth on Schedule 10.3.2, as of the Effective
Date, neither Avalon nor its Affiliates has, directly or
indirectly, expressly or by implication, by action or omission or
otherwise (x) assigned, transferred, granted, conveyed or
otherwise encumbered any right, title or interest in or to any
Patent, know-how or other intellectual property rights owned by,
licensed to or otherwise control-led by Avalon or its Affiliates
with respect to the initial Collaboration Targets listed on
Appendix C that is inconsistent with the rights granted
to Medarex under this Agreement with respect to Collaboration
Products, or (y) agreed to or is otherwise bound by any
covenant not to sue for any infringement, misuse or otherwise with
respect to the foregoing intellectual property rights that is
inconsistent with the rights granted to Medarex under this
Agreement with respect to Collaboration Products. Further, Avalon
represents, warrants and covenants to Medarex that, except as
disclosed to Medarex in writing pursuant to
Section 1.2.2(a)(iv) with respect to an Antigen, as of the
date such Antigen is designated a Collaboration Target, neither
Avalon nor its Affiliates has, directly or indirectly, expressly or
by implication, by action or omission or otherwise
(a) assigned, transferred, granted, conveyed or otherwise
encumbered any right, title or interest in or to any Patent,
know-how or other intellectual property rights owned by, licensed
to or otherwise controlled by Avalon or its Affiliates with respect
to such Collaboration Target that is inconsistent with the rights
granted to Medarex under this Agreement with respect to
Collaboration Products, or (b) agreed to or is otherwise bound
by any covenant not to sue for any infringement, misuse or
otherwise with respect to the foregoing intellectual property
rights that is
* The asterisk
denotes that 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 and Exchange Commission.
34
inconsistent with the rights
granted to Medarex under this Agreement with respect to
Collaboration Products.
Section 10.4 * .
Section 10.5 DISCLAIMER OF WARRANTY . EXCEPT FOR
THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 10.1, 10.2 AND 10.3,
AVALON AND MEDAREX MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, UNDER THIS AGREEMENT OR THE UNILATERAL
DEVELOPMENT AND COMMERCIALIZATION AGREEMENTS, AND AVALON AND
MEDAREX EACH SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE
NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES UNDER THIS AGREEMENT OR THE UNILATERAL DEVELOPMENT AND
COMMERCIALIZATION AGREEMENTS.
ARTICLE 11 -
MISCELLANEOUS
Section 11.1 Force Majeure . Neither Party shall
be held liable or responsible to the other Party or be deemed to
have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond
the reasonable control of the non-performing Party, including
fires, floods, earthquakes, embargoes, shortages, epidemics,
quarantines, war, acts of war (whether war be declared or not) or
terrorism, insurrections, riots, civil commotion, strikes, lockouts
or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority. The non-performing
Party shall notify the other Party of such force majeure within *
after such occurrence by giving written notice to the other Party
stating the nature of the event, its anticipated duration, and any
action being taken to avoid or minimize its effect. The suspension
of performance shall be of no greater scope and no longer duration
than is necessary and the non-performing Party shall use
Commercially Reasonable Efforts to remedy its inability to perform;
provided , however , that in the event the suspension
of performance continues for * after the date of the occurrence,
the Parties shall meet to discuss in good faith how to proceed in
order to accomplish the goals of the collaboration outlined in this
Agreement.
Section 11.2 Subcontractors . Each Party shall
have the right, subject to the prior written consent of the
Steering Committee, such consent not to be unreasonably withheld or
delayed, to subcontract any of its research, development,
manufacture and/or commercialization activities to a Third Party,
provided that it furnishes the other Party with advanced written
notice thereof, which notice shall specify the work to be
subcontracted, and obtains a written undertaking from the
subcontractor that it shall be subject to the applicable terms and
conditions of this Agreement, including the provisions of
Article 6. If a Party wishes to subcontract any of its
research, development, manufacturing or commercialization
activities to a Third Party and the
* The
asterisk denotes that 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 and Exchange Commission.
35
Steering Committee consents, the
other Party may submit a bid to the subcontracting Party to perform
such work. The subcontracting Party shall use Commercially
Reasonable Efforts to enter into an agreement with the bidder that
is best able to meet the Collaboration’s requirements, taking
into consideration such factors as price, quality, capacity,
quantity, reliability and reputation, provided that such bidder is
reasonably acceptable to the Steering Committee. Unless the Project
Plan provides, or the Steering Committee agrees otherwise, * the
costs and expenses associated with the use of a subcontractor to
conduct research, development, manufacture and commercialization
activities, but, unless the Parties agree otherwise, the
subcontracting Party shall remain solely liable for the performance
of its research, development, manufacture or commercialization
activities by its subcontractor; provided , however ,
that Avalon and Medarex each shall remain solely responsible for
all costs and expenses associated with its use of subcontractor(s)
with respect to the Avalon Research Activities and the Medarex
Research Activities, respectively.
Section 11.3 Assignment . Without the prior
written consent of the other Party hereto, neither Party shall
sell, transfer, assign, pledge or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties hereunder; provided
, however , that either Party hereto may assign or transfer
this Agreement or any of its rights or obligations hereunder
without the consent of the other Party (a) to any Affiliate of such
Party; or (b) to any Third Party with which it merges or
consolidates, or to which it transfers all or substantially all of
its assets to which this Agreement relates if in any such event
(i) the assigning Party (provided that it is not the surviving
entity) remains jointly and severally liable with the relevant
Avalon Affiliate, Medarex Affiliate or Third Party assignee under
this Agreement, and (ii) the relevant Avalon Affiliate
assignee, Medarex Affiliate assignee, Third Party assignee or
surviving entity assumes in writing all of the assigning
Party’s obligations under this Agreement. For purposes of
clarification with respect to subsection (b) herein, a Third Party
that merges or consolidates with a Party, or to which a Party
transfers all or substantially all of its assets to which this
Agreement relates, shall not be deemed to grant the other Party to
this Agreement any license to such Third party’s technology
in existence as of the effective date of such merger, consolidation
or transfer, unless such grant is made pursuant to a separate
agreement, provided such Third Party shall maintain all
licenses granted hereunder by such first Party with respect to its
Technology and any Information and Inventions with respect thereto.
Any purported assignment or transfer in violation of this Section
shall be void ab initio and of no force or
effect.
Section 11.4 Severability . If any provision of
this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations
of either Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision shall be fully
severable, (b) this Agreement shall be construed and enforced
as if such illegal, invalid or unenforceable provision had never
comprised a part hereof, (c) the remaining provisions of this
Agreement shall remain in full force and effect and shall not be
affected by the illegal, invalid or unenforceable provision or by
its severance herefrom, and (d) in lieu of such illegal,
invalid or unenforceable provision, there shall be added
automatically as a part of this Agreement a legal, valid and
enforceable provision as similar in terms to such illegal, invalid
or unenforceable provision as may be possible and reasonably
acceptable to the Parties. To the
* The asterisk
denotes that 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 and Exchange Commission.
36
fullest extent permitted by
applicable law, each Party hereby waives any provision of law that
would render any provision prohibited or unenforceable in any
respect.
Section 11.5 Governing Law, Jurisdiction, Venue and
Service.
11.5.1 Governing Law . This Agreement shall be governed by
and construed in accordance with the laws of the State of Delaware,
excluding any conflicts or choice of law rule or principle that
might otherwise refer construction or interpretation of this
Agreement to the substantive law of another
jurisdiction.
11.5.2 Jurisdiction . Subject to Section 2.3, the
parties hereby irrevocably and unconditionally consent to the
exclusive jurisdiction of the courts of the State of Delaware and
the United States District Court for the District of Delaware for
any action, suit or proceeding (other than appeals therefrom)
arising out of or relating to this Agreement, and agree not to
commence any action, suit or proceeding (other than appeals
therefrom) related thereto except in such courts.
11.5.3 Venue . The Parties further hereby irrevocably and
unconditionally waive any objection to the laying of venue of any
action, suit or proceeding (other than appeals therefrom) arising
out of or relating to this Agreement in the courts of the State of
Delaware or the United States District Court for the District of
Delaware, and hereby further irrevocably and unconditionally waive
and agree not to plead or claim in any such court that any such
action, suit or proceeding brought in any such court has been
brought in an inconvenient forum.
11.5.4 Service . Each Party hereto further agrees that
service of any process, summons, notice or document by U.S.
registered mail to its address set forth below shall be effective
service of process for any action, suit or proceeding bought
against it under this Agreement in any such court.
11.5.5 Patents and Trademarks . Notwithstanding the
foregoing, any disputes regarding the validity, scope or
enforceability of Patents or Trademarks shall be submitted to a
court of competent jurisdiction in the territory in which such
rights apply.
Section 11.6 Notices . All notices or other
communications that are required or permitted hereunder shall be in
writing and delivered personally, sent by facsimile (and promptly
confirmed by personal delivery, registered or certified mail or
overnight courier as provided herein), sent by
nationally-recognized overnight courier or sent by registered or
certified mail, postage prepaid, return receipt requested,
addressed as follows:
If to Avalon, to:
Avalon Pharmaceuticals, Inc.
20358 Seneca Meadows Parkway
Germantown, Maryland 20876
Attention: CEO
Facsimile: 301-556-9910
* The asterisk
denotes that 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 and Exchange Commission.
37
If to Medarex, to:
Medarex, Inc.
707 State Road
Princeton, New Jersey 08540-1437
Attention: President
Facsimile: (609) 430-2850
with a copy to:
Medarex, Inc.
707 State Road
Princeton, New Jersey 08540-1437
Attention: General Counsel
Facsimile: (609) 430-4215
or to such other address as the
Party to whom notice is to be given may have furnished to the other
Party in writing in accordance herewith. Any such communication
shall be deemed to have been received (a) when delivered, if
personally delivered or sent by facsimile on a business day,
(b) on the business day after dispatch, if sent by nationally
recognized overnight courier, and (c) on the third business
day following the date of mailing, if sent by mail. It is
understood and agreed that this section 11.6 is not intended to
govern the day-to-day business communications necessary between the
Parties in performing their duties, in due course, under the terms
of this Agreement.
Section 11.7 Entire Agreement; Modifications .
This Agreement, together with the Appendices attached hereto, sets
forth and constitutes the entire agreement and understanding
between the Parties with respect to the subject matter hereof and
all prior agreements, understanding, promises and representations,
whether written or oral, with respect thereto are superseded
hereby. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as
specifically set forth herein. No amendment, modification, release
or discharge shall be binding upon the Parties unless in writing
and duly executed by authorized representatives of both
Parties.
Section 11.8 Relationship of the Parties . It is
expressly agreed that the Parties shall be independent contractors
of one another and that the relationship between the Parties shall
not constitute a partnership, joint venture or agency. Neither
Party shall have the authority to make any statements,
representations or commitments of any kind, or to take any action,
which shall be binding on the other, without the prior written
consent of the other to do so. All persons employed by a Party
shall be employees of such Party and not of the other Party and all
costs and obligations incurred by reason of any such employment
shall be for the account and expense of such Party.
Section 11.9 Equitable Relief . Each Party
acknowledges and agrees that the restrictions set forth in Articles
6 and 7 of this Agreement are reasonable and necessary to protect
the legitimate interests of the other Party and that such other
Party would not have entered into this Agreement in the absence of
such restrictions, and that any violation or threatened
violation
* The asterisk
denotes that 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 and Exchange Commission.
38
of any provision of
Article 6 or 7 will result in irreparable injury to such other
Party. Each party also acknowledges and agrees that in the event of
a violation or threatened violation of any provision of
Article 6 or 7, the other Party shall be entitled to
preliminary and permanent injunctive relief, without the necessity
of proving irreparable injury or actual damages and without the
necessity of having to post a bond, as well as to an equitable
accounting of all earnings, profits and other benefits arising from
any such violation. The rights provided in the immediately
preceding sentence shall be cumulative and in addition to any other
rights or remedies that may be available to such other Party.
Nothing in this Section 11.9 is intended, or should be
construed, to limit such other Party’s right to preliminary
and permanent injunctive relief or any other remedy for a breach of
any other provision of this Agreement.
Section 11.10 Waiver . Any term or condition of
this Agreement may be waived at any time by the Party that is
entitled to the benefit thereof, but no such waiver shall be
effective unless set forth in a written instrument duly executed by
or on behalf of the Party waiving such term or condition. The
waiver by either Party hereto of any right hereunder or of the
failure to perform or of a breach by the other Party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or
otherwise.
Section 11.11 Counterparts . This Agreement may
be executed in two (2) or more counterparts, each of which
shall be deemed an original, but all of which together shall
constitute one and the same instrument.
Section 11.12 No Benefit to Third Parties . The
representations, warranties, covenants and agreements set forth in
this Agreement are for the sole benefit of the Parties hereto and
their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other parties, other than
MRC as provided in the last sentence of
Section 10.3.1.
Section 11.13 Further Assurance . Each Party
shall duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be
necessary or as the other Party may reasonably request in
connection with this Agreement or to carry out more effectively the
provisions and purposes, or to better assure and confirm unto such
other Party its rights and remedies under this
Agreement.
Section 11.14 English Language . This Agreement
has been written and executed in the English language. Any
translation into any other language shall not be an official
version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English
version shall control.
Section 11.15 References . Unless otherwise
specified, (a) references in this Agreement to any Article,
Section, Appendix, Schedule or Exhibit shall mean references to
such Article, Section, Appendix, Schedule or Exhibit of this
Agreement, (b) references in any section to any clause are
references to such clause of such section, and (c) references
to any agreement, instrument or other document in this Agreement
refer to such agreement, instrument or other document as originally
executed or, if subsequently varied, replaced or supplemented from
time
* The asterisk
denotes that 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 and Exchange Commission.
39
to time, as so varied, replaced
or supplemented and in effect at the relevant time of reference
thereto.
Section 11.16 Construction . Except where the
context otherwise requires, wherever used, the singular shall
include the plural, the plural the singular, the use of any gender
shall be applicable to all genders and the word “or” is
used in the inclusive sense (and/or). The captions of this
Agreement are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this
Agreement or the intent of any provision contained in this
Agreement. The term “including” as used herein shall
mean including, without limiting the generality of any description
preceding such term. The language of this Agreement shall be deemed
to be the language mutually chosen by the Parties and no rule of
strict construction shall be applied against either Party
hereto.
[The remainder of this page has been
intentionally left blank.]
* The asterisk
denotes that 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 Secur
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