RESEARCH COLLABORATION AGREEMENT
This Research Collaboration Agreement (the "Agreement") is made and entered
into as of _____ __, 2000 (the "Effective Date") by and between Athersys,
Inc., a Delaware corporation having its principal offices at 0000 Xxxxxxxx
Xxxxxx, Xxxxxxxxx, Xxxx, 00000, on behalf of itself and its wholly owned
subsidiary, Advanced Biotherapeutics, Inc. ("Athersys"), and Gene-Cell,
Inc., a Nevada corporation having its principal offices at 0000 Xxxxxxxx
Xxx. Xxxxxxx, XX 00000 ("Gene-Cell"). Athersys and Gene-Cell are
sometimes referred to herein individually as a "Party" and collectively as
the "Parties."
Recitals
A. Athersys owns technology and intellectual property rights
relating to its techniques referred to as Synthetic Microchromosome vector,
set forth in Exhibit D[, which was developed by or on behalf of Athersys
either through its internal research efforts or through the Supported
Research Agreement between Athersys and Case Western Reserve University.
B. Cell-Gene has intellectual property rights and expertise in
microinjection technology as set forth in exhibit E.
C. The Parties now wish to establish a research collaboration for
determining whether Athersys' Synthetic Microchomosome vectors can be
microinjected into human stem cells or other cell types using Gene-Cell's
microinjection technologies and techniques, and, if successful, whether the
parties should further develop and commercialize the joint technology for
gene therapy applications. To this end, the Parties executed a Letter of
Intent dated February 22, 2000 (the "Letter") and a Collaboration Term
Sheet dated September 8, 2000 (the "Term Sheet"). This Agreement is the
"more fully defined collaboration agreement" that incorporates the terms of
and supersedes the Letter and Term Sheet.
Now, Therefore, in consideration of the foregoing and the covenants
and promises contained in this Agreement, the Parties agree as follows:
1. Definitions
As used herein, the following capitalized terms shall have the
following meanings (with terms defined in the singular having the same
meanings when used in the plural):
1.1 "Affiliate" shall mean, with respect to a Party,
any corporation or other entity that directly or indirectly controls, is
controlled by or is under the common control with such Party. For the
purpose of this definition, "control" shall mean (a) the direct or indirect
ownership of fifty percent (50%) or more of the outstanding shares or other
voting rights of the subject entity to elect directors, or (b) if such amount
of ownership of a foreign entity is not permitted by law, ownership of the
maximum amount of such entity as permitted by law, or (c) the actual
ability to control and direct the management of the subject entity.
1.2 "Athersys Know How" shall mean any Information that is Controlled by
Athersys during the term of this Agreement and relates to Athersys's SMC
Technology and use thereof, and including any Improvements thereto, but
excluding Athersys Patents.
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1.3 "Athersys Patents" shall mean all Patents that are Controlled by
Athersys during the term of the Agreement and claim any aspect of the SMC
Technology and use thereof, including but not limited to U.S. Patent
number 5,695,967.
1.4 "Athersys Reagents" shall mean those specific materials relating to the
Athersys SMC Technology and necessary to Gene-Cell's work under the Research
Program, as generally specified therein.
1.5 "Athersys SMC Technology" means the Synthetic Microchromosome vector
technology owned by Athersys and generally described in Exhibit E hereto.
1.6 "Collaboration Discovery" shall mean any
Research Information (excluding Improvements) that the JRC determines may
have commercial or research potential, as provided in Section 3.2.
1.7 "Collaboration Product" shall mean any
Research Information (excluding Improvements) that the JRC determines may
have commercial or research potential, as provided in Section 3.2.
1.8 "Confidential Information" shall mean:
(a) any proprietary or confidential information or material in tangible form
disclosed by a Party hereunder that is (i) marked as "Confidential" at the
time it is delivered to the receiving Party, or (ii) designated as confidential
or proprietary in a written memorandum executed by the disclosing Party within
thirty (30) days of disclosure; or (b) any proprietary or confidential
information disclosed orally by a Party hereunder that is identified as
confidential or proprietary when disclosed and in a written memorandum
delivered by the disclosing Party to the Receiving Party within thirty (30)
days of such oral disclosure.
1.9 "Control" or "Controlled" shall mean,
with respect to any material, Information or intellectual property right,
that a Party owns or has a license to such material, Information or
intellectual property right and has the ability to grant to the other Party
the licenses or sublicenses thereto as provided for herein without violating
the terms of any agreement with any Third Party.
1.10 "Gene-Cell Technology" shall mean the
Gene-Cell's microinjection technology generally described in Exhibit AE
attached hereto, as such exhibit may be amended by agreement of the Parties.
1.11 "Gene-Cell Know How" shall mean any
Information that is Controlled by Gene-Cell during the term of this
Agreement and that pertains to the Gene-Cell Technology and any
improvements thereto, but excluding Gene-Cell Patents.
1.12 "Gene-Cell Patents" shall mean all Patents
that are Controlled by Gene-Cell during the term of the Agreement and claim
any aspect of the Gene-Cell Technology and use thereof.
1.13 "Improvement" shall mean any Information or
technical or scientific advance developed by either Party (or by any Research
Institution), or jointly, pursuant to this Agreement comprising an
improvement, modification or enhancement to the Gene-Cell Know-How,
Gene-Cell Patents, Gene-Cell Technology, Athersys Know-How, Athersys SMC
Technology, or Athersys Patents.
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1.14 "Information" shall mean information, results and/or
data of any type whatsoever, in any tangible or intangible form whatsoever,
including without limitation, databases, inventions, practices, methods,
techniques, specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, biological, chemical,
biochemical, toxicological and clinical test data, analytical and quality
control data, stability data, studies and procedures, and patent and other
legal information or descriptions.
1.15 "Joint Inventions" shall mean all inventions
arising from the Research Program other than Pre-existing Technologies and
Improvements to the Athersys Know-How, Athersys Patents, Athersys SMC
Technology, Gene-Cell Know-How, Gene-Cell Patents, Gene-Cell Technology.
1.16 "Joint Research Committee" or "JRC"1.16 Joint Research Committee
or JRC has the meaning set forth in Section 2.4.
1.17 "Joint Patents"1.17 Joint Patents shall mean any and all Patents (which
shall be deemed to include certificates of invention and applications for
certificates of invention) that claim any invention within Research
Information, or Joint Inventions, and including all divisions,
continuations, continuations-in-part, reissues, renewals, extensions,
supplementary protection certificates or the like of any of the foregoing
Patents and foreign equivalents thereof, but excluding from the foregoing
any and all Patents to the extent such Patents claim an Improvement.
1.18 Other Product shall mean a composition of matter (such as a
compound or other substance) that comprises or is based on one or more
Collaboration Discoveries and is determined by the JRC under this Agreement
to be a candidate for development into a therapeutic, prophylactic,
diagnostic or research product, but excluding all Product Candidates.
1.19 "Patents" shall mean all issued United States and foreign patents
(including all reissues, extensions, substitutions, re-examinations,
supplementary protection certificates and the like, and patents of
addition) and pending United States and foreign patent applications
(including, without limitation, all provisional and nonprovisional
applications and all continuations, continuations-in-part and divisions
thereof).
1.20 Pre-existing Technologies shall mean, as to Gene-Cell, the
Gene-Cell Know-How, Gene-Cell, Patents and , Gene-Cell Technology and as to
Athersys, the Athersys Know-How, Athersys SMC Technology and Athersys
Patents.
1.21 Product Candidate shall mean a material of potential commercial
value that comprises or is based on one or more Collaboration Discoveries
and is determined by the JRC under this Agreement to be a candidate for
development into a therapeutic or prophylactic product.
1.22 Research Information shall mean all Information, and all
intellectual property rights therein, conceived or reduced to practice by
the Parties, solely or jointly, pursuant to work conducted under the
Research Program, other than the Athersys Know-How, Athersys Patents,
Athersys SMC Technology, Gene-Cell Know-How, Gene-Cell Patents, Gene-Cell
Technology including all Improvements to each.
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1.23 Research Instituion has the meaning set forth in Section 2.1.
1.24 Research Program shall mean the program of collaborative
research to be conducted by the Parties pursuant to the Agreement in
accordance with the Research Protocol. The Research Program may be
modified or amended from time to time upon the mutual written agreement of
the authorized representatives of the Parties, by a written amendment of
the Research Protocol.
1.25 Research Protocol shall mean the agreed plan for the
collaborative research activities of the Parties under this Agreement,
attached hereto as Exhibit A, as such plan may be modified or amended
pursuant to Section 2.2.
1.26 Third Party means any entity other than Athersys, Gene-Cell or
an Affiliate of either of them.
2. Research Program
2.1 General. Athersys and Gene-Cell agree to conduct the Research
Program in accordance with Research Protocol and the other terms and
conditions of this Agreement. Subject to the foregoing, Athersys may
engage one or more research institutions as Athersys may deem necessary and
appropriate ("Research Institutions"), subject to Gene-Cell's approval,
which shall not be unreasonably withheld, to perform certain of Athersys'
obligations under the Research Program; provided, however, that such
Research Institution shall perform such work in compliance with the terms
and conditions of this Agreement. Subject to the first sentence of this
Section 2.1, Gene-Cell may engage one or more of its Affiliates to perform
certain of Gene-Cell's obligations under the Research Program; provided,
however, that such Affiliates shall perform such work in compliance with
the terms and conditions of this.
2.1 Agreement and subject to the approval of Athersys, such approval
not to be unreasonably withheld.
2.2 Conduct of Research. Athersys and Gene-Cell each shall conduct
its obligations under the Research Program in good scientific manner, and
in compliance in all material respects with all requirements of applicable
laws, rules and regulations and applicable industry standard laboratory
practices to attempt to achieve their objectives efficiently and
expeditiously. Athersys and Gene-Cell shall each proceed diligently with
the work set out in the Research Program by using their respective good
faith efforts in accordance with the Research Protocol, and as managed by
the JRC. The JRC may amend or modify, in writing, the Research Protocol.
2.3 Exchange of Material and Information. Promptly after execution of
this Agreement, Athersys shall supply to Gene-Cell the Athersys Know-How
that Athersys determines is needed for Gene-Cell's work, the Athersys
Reagents, and any other material and information specified to be provided
by Athersys in the Research Protocol. Gene-Cell shall promptly disclose to
Athersys during the term of this Agreement the Gene-Cell Know-How that may
be necessary or useful to Athersys in the performance of the Research
Program, or as otherwise required by the Agreement. As more fully outlined
in the Research Protocol, Gene-Cell shall, microinject vectors from the
Athersys SMC Technology into appropriate host cells and provide those
injected cells and related data and information to Athersys, which shall
analyze and characterize the cultured stem cells or other human cells
containing the microinjected SMC vectors that it receives from Gene-Cell.
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2.4 Joint Research Committee. The Parties shall form a Joint Research
Committee ("JRC") that shall be composed of two scientific representatives
appointed by each Party. The Athersys representatives shall initially be
Gil Van Bokkelen, and Xxxxxxx Xxxx; and the Gene-Cell representatives
shall initially be Xxxxx Xxxxx and Xxxxxx Xxxxxxxxxxx-Xxxxx. From time to
time, each Party may substitute one or more of its representatives
effective upon notice to the other Party. It is anticipated that these
representatives shall have the appropriate technical credentials and
knowledge, and ongoing familiarity with the Research Program. The JRC
shall meet at least quarterly during the term of the Research Program to
manage and direct the Research Program, monitor and evaluate the progress
and results of the Research Program, amend in writing the Research Protocol
as appropriate, and evaluate the Research Information to select any Product
Candidates and Collaboration Discoveries for further research and
development under the Agreement. Such meetings may be face-to-face or by
teleconference or videoconference, except that there must be one face-to-face
meeting approximately every six (6) months. The JRC shall confer and
make decisions regarding the status and direction of the Research Program
and the other matters specified in the Research Program or otherwise set
forth in this Agreement. The JRC shall maintain accurate records to
document the discussions and decisions at each meeting. All decisions of
the JRC shall be by unanimous consent. The JRC shall adopt reasonable
procedures to promote prompt consensus on all matters requiring JRC
decision, including development decisions and costs, and to resolve any
disagreements relating thereto. In the event of any unresolved differences
with respect to issues that come before the JRC, such differences shall be
resolved pursuant to Article 8 of this Agreement.
2.5 Records and Reports.
(a) Records. Athersys and Gene-Cell shall maintain records that
shall be complete and accurate and shall fully and properly reflect all
work done and all results achieved, including raw data, in the performance
of the Research Program ("Records"). The Records shall be kept with
sufficient detail and in good scientific manner appropriate for patent and
regulatory purposes and shall allow thorough evaluation of all Research
Information, Improvements and including potential Product Candidates and
Collaboration Discoveries and shall be kept separately from all other work
conducted by Athersys and Gene-Cell.
(b) Copies and Inspection of Records. Athersys and Gene-Cell
shall have the right, during normal business hours and upon reasonable
notice to inspect and copy all of the other Party's Records referenced in
Section 2.5(a). The Parties shall maintain such Records and the Information
disclosed therein in confidence in accordance with Article 5. All
inspections, copying and visits hereunder shall be conducted in a manner so
as not to disrupt significantly the other Party's business or cause any
disclosure of any other information confidential to the other Party.
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(c) Quarterly Reports. Within 30 days following the end of each
calendar quarter during the term of this Agreement, each Party shall
provide the other Party a written progress report that shall describe the
work performed to date on the Research Program, evaluate the work performed
in relation to the goals of the Research Program, summarize all relevant
Research Information created or developed and provide such other
Information required by the Research Program or reasonably requested by
Athersys or Gene-Cell relating to the progress of the goals or performance
of the Research Program. Upon request, each Party shall promptly provide
copies of its Records, described in Section 2.5(a) above, to the other
Party. With such reports, each Party shall disclose and describe to the
other Party in summary form the development, making, conception or
reduction to practice of all Research Information and Improvements that are
discovered, made, conceived or reduced to practice under the Research
Program, and shall identify in detail all such Research Information that
the reporting Party believes may be Collaboration Discoveries.
2.6 Research Program Term. Except as otherwise provided herein, the
term of the Research Program shall commence on the Effective Date and
continue for a period of three (3) years (the "Research Program Term")
except that either Party may terminate the Research Program and this
Agreement in accordance with Section 10. The Parties may, by mutual
written agreement executed by authorized representatives, extend the
Research Program Term for one or more additional years. Upon extension of
the Research Program Term, if applicable, Exhibit A setting forth the
Research Protocol shall be amended in writing by mutual agreement of the
Parties as appropriate to address the work to be conducted during such
extension.
3. Development of Collaboration Discoveries.
3.1 General. The Parties anticipate that the Research Program may
result in Collaboration Discoveries that may be developed and
commercialized as Product Candidates or as Other Products, as applicable.
The Parties agree that they shall pursue the development and
commercialization of all products based on Collaboration Discoveries solely
as provided in this Article 3.
3.2 Determination of Product Candidates and Collaboration Discoveries.
The JRC shall have the sole authority to select and designate
particular Research Information as constituting a Product Candidate or
other Collaboration Discovery. The JRC, upon designating a Product
Candidate or other Collaboration Discovery, shall promptly and
simultaneously notify in writing each Party of such designation,
identifying in detail the Product Candidate or other Collaboration
Discovery and the commercial use intended therefore. Each Party shall have
the right, under Section 2.5, to inspect all Research Information to
evaluate the Product Candidate or Collaboration Discovery.
3.3 Rights to Develop and Commercialize. After the JRC has
identified and designated a Product Candidate or a Collaboration Discovery,
each Party shall have the rights set forth below to elect to develop and
commercialize the Product Candidate or other Product based on such
Collaboration Discovery. Each Party shall provide the other Party written
notice, as soon as possible but in no event later than thirty (30) days
after receiving notification from the JRC of a Product Candidate or
Collaboration Discovery, of whether the Party wishes to develop and
commercialize the Product Candidate or other Product based on such
Collaboration Discovery. If a Party wishes to develop and commercialize
such Product Candidate or Other Product, as applicable, (a "Participating
Party"), it shall notify the other Party in the form set forth in Exhibit B
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(a "Notice of Participation"). If a Party declines to develop and
commercialize a Product Candidate or Other Product, as applicable,
(a "Non-Participating Party"), it shall notify the other Party of such
decision in the form set forth in Exhibit C (a "Participation Waiver").
3.4 Co-Development by the Parties.
(a) General. If both Parties elect, as provided in Section 3.3,
to be a Participating Party to develop and commercialize a particular
Product Candidate or Other Product, representatives of each Party shall
meet to establish the terms under which such development and
commercialization shall proceed, which shall be set forth in a development
agreement ("Development Agreement") to be negotiated in good faith and
entered into between the Parties for such purpose. Each such Development
Agreement shall specify that the Parties shall share equally in the costs
of developing and commercializing the applicable Collaboration Product or
Other Product and in the profits from such commercialization, unless
otherwise agreed, and shall establish the roles of each Party in and the
mechanisms for pursuing such development and commercialization.
(b) Withdrawal by One Party. If, under a particular Development
Agreement, a Participating Party desires to cease continuing its
participation in the joint development conducted under such Development
Agreement pursuant to Section 3.4(a), such Party (thereafter, the
"Withdrawing Party") shall notify the other Party of such decision in the
form of a Participation Waiver set forth in Exhibit C. Promptly
thereafter, the Parties shall negotiate a Non-Participation License as
contemplated in Section 3.5, which agreement shall also provide for
additional provisions to compensate the Withdrawing Party (by an adjustment
to the royalty rate or as otherwise agreed by the Parties) for the actual
expenses the Withdrawing Party incurred in developing the applicable
Collaboration Product or Other Product under such Development Agreement.
The Withdrawing Party shall not be entitled to any share of profits
realized from the commercialization of such Collaboration Product or Other
Product, (as applicable), and instead shall receive payment as provided in
such Non-Participation License.
(c) Withdrawal of Both Participating Parties. If both
Participating Parties decide they shall withdraw from further joint
development work under a particular Development Agreement, the Parties may
elect to license the Collaboration Product or Other Product (as applicable)
covered by such Development Agreement, as provided in Section 3.6; the
revenues received from licensing such Collaboration Product or Other
Product shall be shared in percentages equal to the percentage of the total
development costs incurred and paid by each Party under such Development
Agreement prior to such election to withdraw.
3.5 Development and Commercialization by One Party.
If only one Party elects under Section 3.3 to be the Participating
Party to develop and commercialize a particular Collaboration Product or
Other Product (as applicable), the Parties shall negotiate in good faith
and execute a separate license agreement for such Collaboration Product or
Other Product (as applicable) subject to the Participation Waiver (the
"Non-Participation License"). Such Non-Participation License shall require
that the Participating Party shall pay the Non-Participating Party a
royalty as set forth in Exhibit C, subject to such Participation Waiver
(the "Non-Participation Royalty"); provided, however, that if the total
royalty burden on such Collaboration Product or Other Product exceeds
fifteen percent (15%), the Parties shall negotiate in good faith and agree
upon a lower Non-Participation Royalty in order to preserve the viability
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of the Collaboration Product or Other Product. Such Non-Participation
License shall further require that, if the Participating Party sublicenses
such Collaboration Product or Other Product to a Third Party, such Third
Party shall be required to pay the Non-Participation Royalty directly to
the Non-Participating Party. In addition to the terms set forth herein,
all Non-Participation Licenses shall contain customary terms, including a
commercially reasonable definition of "net sales" and other terms and
conditions relating to payments; patent rights and related protection and
prosecutions; auditing and review rights and confidentiality;
representations and warranties; indemnities; and prohibition of assignment.
3.6 License to Third Parties. If neither Party elects under Section
3.3 to develop and commercialize a particular Collaboration Product or
Other Product (as applicable), the Parties may jointly decide to license
the Product Candidate or other Product or related Collaboration Discovery
to a Third Party. Neither Party shall have the sole right, on its own and
without agreement of the other Party, to license a Product Candidate, Other
Product or Collaboration Discovery to any Third Party, but each Party
agrees to use good faith diligent efforts to cooperate with the other Party
in seeking to obtain such license agreement so as to maximize the
commercial value to the Parties of such Collaboration Discoveries, Other
Product or Product Candidates. All amounts to be received from such
licensing to Third Party shall be shared equally by the Parties unless
otherwise agreed.
3.7 Failure to Disclose Research Information. If a Party fails to
disclose to the other Party any Research Information as required by this
Agreement, and which is later determined to be a commercially-useful
invention or product opportunity, the non-disclosing Party shall waive all
right, title and ownership to the undisclosed Research Information.
4. Licenses and Limitations.
4.1 Grant by Athersys. Subject to the terms of this Agreement,
Athersys hereby grants to Gene-Cell a nonexclusive, limited license,
including the right to sublicense Affiliates solely as permitted in Section
2.1, under the Athersys Know-How and Athersys Patents solely to conduct
Gene-Cell's obligations under the Research Program.
4.2 Grant by Gene-Cell. Subject to the terms of this Agreement,
Gene-Cell hereby grants to Athersys the nonexclusive, limited license,
including the right to sublicense to Research Institutions solely as
permitted in Section 2.1, under the Gene-Cell Know-How and Gene-Cell
Patents solely to conduct Athersys' obligations under the Research Program.
4.3 Commercial Licenses. Upon the effectiveness of a Participation
Waiver as set forth in Sections 3.3 or 3.4(b), the Non-Participating Party
shall grant to the Participating Party an exclusive, worldwide license,
with rights to sub-license, under the Non-Participating Party's interests
in the Research Information and Joint Patents, to make, use, and sell the
particular Collaboration Product or Other Product subject to such
Participation Waiver.
4.4 Limitations. Athersys and Gene-Cell each covenants that it shall
not use or practice the other Party's know-how or Patents licensed in
Sections 4.1, 4.2, and 4.3 except as expressly provided and permitted for
the specific purposes for which the license is granted, and for no other
purpose.
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5. Intellectual Property.
5.1 Ownership.
(a) Athersys Intellectual Property. Athersys shall remain the sole
owner of the Athersys Know-How, including but not limited to the Athersys
SMC Technology, and of the Athersys Reagents and the Athersys Patents, and
of any Improvements to any such property made by either Party or jointly.
Athersys shall have the sole right and responsibility, at its sole
discretion, for patent prosecution and choice of patent counsel in relation
to Athersys Know-How, the Athersys SMC Technology and Athersys Patents,
including any Improvements, and shall pay all expenses associated
therewith. Gene-Cell (and its Affiliates, if applicable) hereby assigns
and agrees to assign to Athersys its entire interest in any Improvements to
the Athersys Know-How, Athersys SMC Technology and/or Athersys Patents.
(b) Gene-Cell Intellectual Property. Gene-Cell shall remain the sole
owner of the Gene-Cell Know-How, including but not limited to the Gene-Cell
Technology, and of the Gene-Cell Patents, and of any Improvements to either
made by either Party or jointly. Gene-Cell shall have the sole right and
responsibility, at its sole discretion, for patent prosecution and choice
of patent counsel in relation to Gene-Cell Know-How and Gene-Cell Patents,
including any improvements, and shall pay all expenses associated
therewith. Athersys (and each Research Institution, if applicable) hereby
assigns and agrees to assign to Gene-Cell its entire interest in any
Improvements to the Gene-Cell Know-How and/or Gene-Cell Patents.
(c) Joint Intellectual Property. Subject to the other terms of the
Agreement, Athersys and Gene-Cell shall each own an undivided one-half
interest in and to any and all Research Information and all intellectual
property rights claiming or covering or appurtenant thereto (including the
Joint Inventions and Joint Patents), but excluding all Improvements.
Athersys and Gene-Cell shall have the right to grant licenses under such
Research Information and Joint Inventions and the Joint Patents, but only
subject to all limitations thereon provided for in this Agreement with
respect to all Collaboration Discoveries.
5.2 Patent Prosecution and Maintenance; Abandonment.
(a) Pre-existing Technologies. Each Party shall retain control over
and bear all expenses associated with the filing, prosecution and
maintenance of all of that Party's Patents claiming its Pre-existing
Technologies.
(b) Joint Inventions. The JRC shall establish the patent strategy for
all Joint Patents claiming inventions in the Research Information or Joint
Inventions, consistent with a future Development Agreement relating to such
inventions. The JRC shall supervise and direct the filing, prosecution and
maintenance of all Joint Patents. The JRC shall provide each Party with
(i) drafts of any new patent application that covers inventions in Research
Information or Joint Inventions prior to filing that application, allowing
adequate time for review and comment by the Party if possible; provided,
however, the JRC shall not be obligated to delay the filing of any patent
application; and (ii) copies of all correspondence from any and all patent
offices concerning patent applications covering Joint Inventions and an
opportunity to comment on any proposed responses, voluntary amendments and
submissions of any kind to be made to any and all such patent offices. The
Parties shall share equally in the costs and expenses of patent prosecution
of Joint Inventions unless the Parties agree in writing to different terms.
(c) Improvements. A Party that owns an Improvement (as provided in
Section 4.1) shall have the sole right, at its discretion, to pursue
Patents claiming inventions therein.
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5.3 Enforcement of Patent Rights.
(a) Pre-Existing Technologies. Each Party shall have the sole right,
but not the obligation, to institute, prosecute or control any action or
proceeding with respect to infringement by a Third Party of one or more
issued Patents covering the Party's Pre-existing Technologies.
(b) Joint Patents. If either Party becomes aware of conduct by a
Third Party that potentially infringes one or more Joint Patents, that
Party shall notify the other Party in writing (the "Notice") of the
potential infringement within ten (10) days of becoming aware of such
infringement. The Parties shall promptly confer to discuss the potential
infringement and, within thirty (30) days of the Notice, shall determine a
course of action including, without limitation, the commencement of legal
action by either or both of Athersys and Gene-Cell to terminate any such
infringement. Except as otherwise provided in any Development Agreement or
Non-Participation License (as set forth in Sections 3.4 and 3.5,
respectively) with respect to the applicable Joint Patent, each Party shall
have the right, but not the obligation, to initiate such legal action at
its sole expense. If only one Party takes such legal action at its sole
cost, that Party alone shall be entitled to all damages awarded or any
settlement paid as a result of such legal action. If both Parties commence
such legal action jointly, the Parties shall share equally all costs and
all recovered damages or settlement payments arising from such legal
action.
6. Confidentiality.
6.1 Confidential Information. Except as expressly provided herein,
the Parties agree that, for the term of this Agreement and for five (5)
years thereafter, the receiving Party shall keep completely confidential
and shall not publish or otherwise disclose and shall not use for any
purpose except for the purposes contemplated and permitted by this
Agreement any Confidential Information furnished to it by the disclosing
Party hereto pursuant to this Agreement, except that to the extent that it
can be established by the receiving Party by competent written evidence
that such Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;
(d) was independently developed by the receiving Party as
demonstrated by competent written evidence prepared contemporaneously with
such independent development; or
(e) was subsequently lawfully disclosed to the receiving Party by a
person other than a Party hereto.
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6.2 Authorized Disclosure. Notwithstanding the foregoing, a Party
may disclose the Confidential Information of the other Party to the extent
such disclosure is reasonably necessary in the following instances:
(a) Regulatory filings;
(b) Prosecuting or defending litigation;
(c) Complying with applicable governmental regulations;
(d) Conducting clinical trials;
(e) Making a permitted sublicense;
(f) Disclosure, in connection with the performance of this Agreement,
to Affiliates, Research Institutions, sublicensees, research collaborators,
employees, consultants, or agents, each of whom prior to disclosure must be
bound by similar obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this Article 6; and
(g) Disclosure to existing or potential investment bankers, investors
and/or merger or acquisition parties, provided that the disclosing Party
uses reasonable efforts to obtain from such recipient prior to disclosure
an agreement to be bound by obligations of confidentiality and non-use at
least similar in scope to those set forth in this Article 6.
If a Party is required to make any disclosure of another Party's
confidential information that is authorized under this Section 6.2, other
than pursuant to a confidentiality agreement, it will give reasonable
advance notice to the latter Party of such disclosure and, save to the
extent inappropriate in the case of patent applications, will use its best
efforts to secure confidential treatment of such information prior to its
disclosure (whether through protective orders or otherwise) and to limit
the extent of the disclosure as much as possible.
6.3 Public Disclosure. Except as otherwise required by law, neither
Party shall issue a press release or make any other disclosure of the terms
of this Agreement or any aspect of the research conducted pursuant to this
Agreement without the prior approval of such press release or disclosure by
the other Party hereto. Each Party shall submit any such press release or
disclosure to the other Party, and the receiving Party shall have five (5)
days to review and approve any such press release or disclosure, which
approval shall not be unreasonably withheld. In addition, if a public
disclosure is required by law, including without limitation in a filing
with the Securities and Exchange Commission, the disclosing Party shall
provide copies of the disclosure reasonably in advance of such filing or
other disclosure for the nondisclosing Party's prior review and comment.
6.4 Confidential Terms. Except as expressly provided herein, each
Party agrees not to disclose any terms of this Agreement or any aspect of
the research conducted pursuant to this Agreement to any Third Party
without the consent of the other Party; provided, however, that either
Party shall have the right to disclose the material terms of this Agreement
under strictures of confidentiality to any potential acquirer, candidate
merger, partner, investment bank, venture capital firm, or other financial
institution or investor to obtain financing; and provided further that
either Party shall have the right to disclose the material terms of this
Agreement under strictures of confidentiality to any bona fide potential
strategic partner and to Affiliates.
7. Representations and Warranties.
7.1 Athersys. Athersys represents and warrants that: (i) it is a
corporation duly organized validly existing and in good standing under the
laws of the State of Delaware; (ii) the execution, delivery and performance
of this Agreement have been duly authorized by all necessary corporate
action on the part of Athersys; (iii) Athersys has the right to grant the
license and rights granted in this Agreement; and (iv) there are no
agreements of Athersys with any Third Parties that would prevent the grant
of the licenses granted in this Agreement.
7.2 Gene-Cell. Gene-Cell represents and warrants that: (i) it is a
corporation duly organized validly existing and in good standing under the
laws of the State of Nevada; and (ii) the execution, delivery and
performance of this Agreement have been duly authorized by all necessary
corporate action on the part of Gene-Cell; (iii) Gene-Cell has the right to
grant the license and rights granted in this Agreement; and (iv) there are
no agreements of Gene-Cell with any Third Parties that would prevent the
grant of the licenses granted in this Agreement.
7.3 Disclaimer of Warranties. EACH PARTY'S KNOW-HOW AND PATENTS ARE
PROVIDED AND LICENSED TO THE OTHER "AS IS", AND NEITHER PARTY MAKES ANY
REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT THERETO OR TO THE PRODUCTS BASED THEREON,
INCLUDING, BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, VALIDITY OF THE PATENT RIGHTS LICENSED HEREUNDER,
OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
8. Dispute Resolution.
8.1 Mediation. If a dispute arises out of or relates to this
Agreement, or the breach thereof, and if such dispute cannot be settled
promptly, the Parties agree first to try in good faith to settle the
dispute by good faith discussions between the CEOs of each Party. If such
discussions do not resolve the dispute within thirty (30) days after a
Party has referred the dispute to resolution by the CEOs, the Parties agree
to submit such dispute within twenty (20) days to non-binding mediation
under the Commercial Mediation Rules of the American Arbitration
Association. If such mediation fails to resolve the dispute within ninety
(90) days, either Party may proceed to seek any remedies available to it.
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8.2 Arbitration. Subject to Section 8.1, Athersys and Gene-Cell
agree that any dispute or controversy arising out of, in relation to, or in
connection with this Agreement, or the validity, enforceability,
construction, performance or breach thereof, shall be settled by binding
arbitration in New York, New York, United States of America, under the
then-current Rules of Commercial Arbitration of the American Arbitration
Association by one (1) arbitrator appointed in accordance with such Rules.
The arbitrators shall determine what discovery will be permitted, based on
the principle of limiting the cost and time that the Parties must expend on
discovery; provided, however, that the arbitrators shall permit such
discovery as they deem necessary to achieve an equitable resolution of the
dispute. The decision and/or award rendered by the arbitrator shall be
written, final and non-appealable and may be entered in any court of
competent jurisdiction. The Parties agree that, any provision of
applicable law notwithstanding, they will not request, and the arbitrator
shall have no authority to award punitive or exemplary damages against any
Party. The costs of any arbitration, including administrative fees and fees
of the arbitrator, shall be shared equally by the Parties, unless the
arbitrator determines otherwise.
9. Indemnification.
9.1 Gene-Cell. Gene-Cell shall indemnify, defend and hold harmless
Athersys and its directors, officers and employees (each an "Athersys
Indemnitee") from and against any and all liabilities, damages, losses,
costs or expenses (including attorneys' and professional fees and other
expenses of litigation and/or arbitration) (each a "Liability") resulting
from a claim, suit or proceeding made or brought by a Third Party against
an Athersys Indemnitee arising from or occurring as a result of (i) any
breach of the representations and warranties set forth in Section 7, or
(ii) the performance by Gene-Cell of its obligations hereunder, or (iii)
any development, testing, manufacture, importation, use, offer for sale,
sale or other distribution of any Collaboration Product or Other Product by
Gene-Cell or its Affiliates or its sublicensees (including, without
limitation, product liability and patent infringement claims), pursuant to
Section 3.5, where Gene-Cell is the Participating Party with respect
thereto, except, in each case, to the extent caused by the negligence or
willful misconduct of Athersys.
9.2 Athersys. Athersys shall indemnify, defend and hold harmless
Gene-Cell and its directors, officers and employees (each an "Gene-Cell
Indemnitee") from and against any and all liabilities, damages, losses,
costs or expenses (including attorneys' and professional fees and other
expenses of litigation and/or arbitration) (each a "Liability") resulting
from a claim, suit or proceeding made or brought by a Third Party against a
Gene-Cell Indemnitee, arising from or occurring as a result of (i) any
breach of the representations and warranties set forth in Section 7, (ii)
any development, testing, manufacture, importation, use, offer for sale,
sale or other distribution of any Collaboration Product or Other Product by
Athersys or its Affiliates or Sublicensees (including, without limitation,
product liability and patent infringement claims) pursuant to Section 3.5
where Athersys is the Participating Party with respect thereto, except in
each case to the extent caused by the negligence or willful misconduct of
Gene-Cell.
9.3 Procedure. In the event that any Indemnitee intends to claim
indemnification under this Article 9, it shall promptly notify the other
Party (the "Indemnitor") in writing of such alleged Liability. The
Indemnitor shall have the sole right to control the defense and settlement
thereof. The Indemnitees shall cooperate with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability
covered by this Article 13. The Indemnitee shall not, except at its own
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cost, voluntarily make any payment or incur any expense with respect to any
claim or suit without the prior written consent of the Indemnitor, which
the Indemnitor shall not be required to give.
10. Termination.
10.1 Termination for Cause. Either Party may terminate this Agreement
in the event the other Party has materially breached or defaulted in the
performance of any of its obligations hereunder, and such default has
continued for sixty (60) days after written notice thereof was provided to
the breaching Party by the non-breaching Party. Any termination shall
become effective at the end of such sixty (60) day period unless the
breaching Party has cured any such breach or default prior to the
expiration of the sixty (60) day period. Notwithstanding the above, in the
case of a failure to timely pay any amounts due hereunder, the period for
cure of any subsequent default following notice thereof shall be thirty
(30) days and, unless payment is made within such period the termination
shall become effective at the end of such period.
10.2 Termination Upon Merger or Acquisition. Either Party may
terminate this Agreement in the event that the other Party has merged with
or been acquired by a competitor of the terminating party. The
terminating Party shall provide the other Party with written notification
of its intent to terminate within sixty (60) days after the closing of such
merger or acquisition, and the termination shall become effective ninety
(90) days after the date of such notification. During such time, the
Parties will negotiate in good faith and agree in writing upon the terms of
such termination.
10.3 Termination Without Cause. Either Party may terminate the
Agreement at any time on 90 days written notice, provided that Article 3
and Article 4 shall remain in place for all Research Information discovered
prior to such termination.
10.4 Effect of Termination.
(a) Accrued Rights and Obligations. Termination of this Agreement for
any reason shall not release any Party hereto from any liability that, at
the time of such termination, has already accrued to the other Party or
which is attributable to a period prior to such termination nor preclude
either Party from pursuing any rights and remedies it may have hereunder or
at law or in equity with respect to any breach of this Agreement. It is
understood and agreed that monetary damages may not be a sufficient remedy
for any breach of this Agreement and that the non-breaching Party may be
entitled to injunctive relief as a remedy for any such breach.
(b) Return of Confidential Information. Upon any termination of this
Agreement, Athersys and Gene-Cell shall promptly return to the other Party
all Confidential Information of the other; provided counsel of each Party
may retain one (1) copy of such Confidential Information solely for
archival purposes and for ensuring compliance with Article 2.6(a).
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(c) Survival. Sections 3.4, 3.5, 3.6, 7.3 and 10.4, and Articles 5,
6, 7, 8, 9 and 11 of this Agreement shall survive termination of this
Agreement for any reason.
11. Miscellaneous.
11.1 Governing Law. This Agreement and any dispute, including without
limitation any arbitration, arising from the performance or breach hereof
shall be governed by and construed and enforced in accordance with the laws
of the state of New York, without giving effect to its conflict of laws
rules and regulations.
11.2 Independent Contractors. The relationship of the parties hereto
is that of independent contractors. The parties hereto are not deemed to
be agents, partners or joint venturers of the others for any purpose as a
result of this Agreement or the transactions contemplated thereby.
11.3 Assignment. Neither Party may assign its rights or obligations
under this Agreement absent the prior written consent of the other Party.
11.4 Notices. All notices, requests and other communications
hereunder shall be in writing and shall be personally delivered or sent by
telecopy or other electronic facsimile transmission or by registered or
certified mail, return receipt requested, postage prepaid, in each case to
the respective address specified below, or such other address as may be
specified in writing to the other parties hereto:
If to Gene-Cell: Gene-Cell, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx, Xxxxx 00000
Attn: President
Fax No.: (000) 000-0000
If to Athersys: Athersys, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxx 00000-0000
Attn: President
Fax No.: (000) 000-0000
11.5 Force Majeure. Neither Party shall lose any rights hereunder or
be liable to the other Party for damages or losses (except for payment
obligations) on account of failure of performance by the defaulting Party
if the failure is occasioned by war, strike, fire, Act of God, earthquake,
flood, lockout, embargo, governmental acts or orders or restrictions,
failure of suppliers, or any other reason where failure to perform is
beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming Party has exerted all reasonable
efforts to avoid or remedy such force majeure; provided, however, that in
no event shall a Party be required to settle any labor dispute or
disturbance.
11.6 Advice of Counsel. Gene-Cell and Athersys have each consulted
counsel of their choice regarding this Agreement, and each acknowledges and
agrees that this Agreement shall not be deemed to have been drafted by one
Party or another and will be construed accordingly.
11.7 Compliance with Laws. Each Party will comply with all applicable
laws and regulations in connection with its performance under this
Agreement. Each Party shall furnish to the other Party any information
requested or required by that Party during the term of this Agreement or
any extensions hereof to enable that Party to comply with the requirements
of any U.S. or foreign federal, state and/or government agency.
15
11.8 Further Assurances. At any time or from time to time on and
after the date of this Agreement, either Party shall at the request of the
other Party hereto (i) execute, and deliver or cause to be delivered, all
such consents, documents or further instruments of transfer or license as
required by this Agreement, and (ii) take or cause to be taken all such
actions as are necessary for the compliance with the terms and intent of
this Agreement and the transactions contemplated hereby.
11.9 Severability. In the event that any provisions of this Agreement
are determined to be invalid or unenforceable by a court of competent
jurisdiction, the remainder of the Agreement shall remain in full force and
effect without said provision. In such event, the parties shall in good
faith negotiate a substitute clause for any provision declared invalid or
unenforceable, which shall most nearly approximate the intent of the
parties in entering this Agreement.
11.10 Waiver. It is agreed that no waiver by either Party hereto
of any breach or default of any of the covenants or agreements herein set
forth shall be deemed a waiver as to any subsequent and/or similar breach
or default.
11.11 Complete Agreement. This Agreement, together with its
Exhibits, constitutes the entire agreement, both written and oral, between
the Parties with respect to the subject matter hereof, and that all prior
agreements, including the Letter, respecting the subject matter hereof,
either written or oral, expressed or implied, are merged and canceled, and
are null and void and of no effect. No amendment or change hereof or
addition hereto shall be effective or binding on either of the parties
hereto unless reduced to writing and duly executed on behalf of both
parties.
11.12 Use of Name. Unless otherwise permitted by this Agreement
or required by applicable laws or regulations, neither Party shall use the
name or trademarks of the other Party without the prior written consent of
such other Party.
11.13 Headings. The captions to the several Sections and Articles
hereof are not a part of this Agreement, but are included merely for
convenience of reference only and shall not affect its meaning or
interpretation.
11.14 Counterparts. This Agreement may be executed in two
counterparts, each of which shall be deemed an original and which together
shall constitute one instrument.
In Witness Whereof, Gene-Cell and Athersys have executed this
Agreement by their respective duly authorized representatives.
Gene-Cell, Inc. Athersys, Inc.
By: /S/ Xxxxx X. Xxxxx By: /S/ Xxxx XxxXxxxxxxx
---------------------- ------------------------
Print Name; Xxxxx X. Xxxxx Print Name: Xxxx XxxXxxxxxxx
Title: President & CEO Title: Presient & CEO
