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Exhibit 10.14
RESEARCH COLLABORATION AGREEMENT
ATHERSYS, INC.
AND
GENE-CELL, INC.
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TABLE OF CONTENTS
PAGE
1. DEFINITIONS..............................................................................................1
1.1 "Affiliate".....................................................................................1
1.2 "Athersys Know How".............................................................................1
1.3 "Athersys Patents"..............................................................................2
1.4 "Athersys Reagents".............................................................................2
1.5 "Athersys SMC Technology".......................................................................2
1.6 "Collaboration Discovery".......................................................................2
1.7 "Collaboration Product".........................................................................2
1.8 "Confidential Information"......................................................................2
1.9 "Control" or "Controlled".......................................................................2
1.10 "Gene-Cell Technology"..........................................................................2
1.11 "Gene-Cell Know How"............................................................................2
1.12 "Gene-Cell Patents".............................................................................2
1.13 "Improvement"...................................................................................2
1.14 "Information"...................................................................................3
1.15 "Joint Inventions"..............................................................................3
1.16 "Joint Research Committee" or "JRC".............................................................3
1.17 "Joint Patents".................................................................................3
1.18 "Other Product".................................................................................3
1.19 "Patents".......................................................................................3
1.20 "Pre-existing Technologies".....................................................................3
1.21 "Product Candidate".............................................................................3
1.22 "Research Information"..........................................................................3
1.23 "Research Instituion"...........................................................................4
1.24 "Research Program"..............................................................................4
1.25 "Research Protocol".............................................................................4
1.26 "Third Party"...................................................................................4
2. RESEARCH PROGRAM.........................................................................................4
2.1 General.........................................................................................4
2.2 Conduct of Research.............................................................................4
2.3 Exchange of Material and Information............................................................4
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TABLE OF CONTENTS
(CONTINUED)
PAGE
2.4 Joint Research Committee........................................................................5
2.5 Records and Reports.............................................................................5
(a) Records................................................................................5
(b) Copies and Inspection of Records.......................................................5
(c) Quarterly Reports......................................................................5
2.6 Research Program Term...........................................................................6
3. DEVELOPMENT OF COLLABORATION DISCOVERIES.................................................................6
3.1 General.........................................................................................6
3.2 Determination of Product Candidates and Collaboration Discoveries...............................6
3.3 Rights to Develop and Commercialize.............................................................6
3.4 Co-Development by the Parties...................................................................7
(a) General................................................................................7
(b) Withdrawal by One Party................................................................7
(c) Withdrawal of Both Participating Parties...............................................7
3.5 Development and Commercialization by One Party..................................................7
3.6 License to Third Parties........................................................................8
3.7 Failure to Disclose Research Information........................................................8
4. LICENSES AND LIMITATIONS.................................................................................8
4.1 Grant by Athersys...............................................................................8
4.2 Grant by Gene-Cell..............................................................................8
4.3 Commercial Licenses.............................................................................8
4.4 Limitations.....................................................................................8
5. INTELLECTUAL PROPERTY....................................................................................9
5.1 Ownership.......................................................................................9
(a) Athersys Intellectual Property.........................................................9
(b) Gene-Cell Intellectual Property........................................................9
(c) Joint Intellectual Property............................................................9
5.2 Patent Prosecution and Maintenance; Abandonment.................................................9
(a) Pre-existing Technologies..............................................................9
(b) Joint Inventions.......................................................................9
(c) Improvements..........................................................................10
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TABLE OF CONTENTS
(CONTINUED)
PAGE
5.3 Enforcement of Patent Rights...................................................................10
(a) Pre-Existing Technologies.............................................................10
(b) Joint Patents.........................................................................10
6. CONFIDENTIALITY.........................................................................................10
6.1 Confidential Information.......................................................................10
6.2 Authorized Disclosure..........................................................................11
6.3 Public Disclosure..............................................................................11
6.4 Confidential Terms.............................................................................12
7. REPRESENTATIONS AND WARRANTIES..........................................................................12
7.1 Athersys.......................................................................................12
7.2 Gene-Cell......................................................................................12
7.3 Disclaimer of Warranties.......................................................................12
8. DISPUTE RESOLUTION......................................................................................12
8.1 Mediation......................................................................................12
8.2 Arbitration....................................................................................13
9. INDEMNIFICATION.........................................................................................13
9.1 Gene-Cell......................................................................................13
9.2 Athersys.......................................................................................13
9.3 Procedure......................................................................................13
10. TERMINATION.............................................................................................14
10.1 Termination for Cause..........................................................................14
10.2 Termination Upon Merger or Acquisition.........................................................14
10.3 Termination Without Cause......................................................................14
10.4 Effect of Termination..........................................................................14
(a) Accrued Rights and Obligations........................................................14
(b) Return of Confidential Information....................................................14
(c) Survival..............................................................................14
11. MISCELLANEOUS...........................................................................................15
11.1 Governing Law..................................................................................15
11.2 Independent Contractors........................................................................15
11.3 Assignment.....................................................................................15
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TABLE OF CONTENTS
(CONTINUED)
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11.4 Notices........................................................................................15
11.5 Force Majeure..................................................................................15
11.6 Advice of Counsel..............................................................................15
11.7 Compliance with Laws...........................................................................15
11.8 Further Assurances.............................................................................16
11.9 Severability...................................................................................16
11.10 Waiver.........................................................................................16
11.11 Complete Agreement.............................................................................16
11.12 Use of Name....................................................................................16
11.13 Headings.......................................................................................16
11.14 Counterparts...................................................................................16
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RESEARCH COLLABORATION AGREEMENT
THIS RESEARCH COLLABORATION AGREEMENT (the "Agreement") is made and entered into
as of September 20, 2000 (the "Effective Date") by and between ATHERSYS, INC., a
Delaware corporation having its principal offices at 3201 Carnegie Avenue,
Cleveland, Ohio, 44115, 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 1010 Hercules Ave. Houston, TX 77058
("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 E 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
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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.
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" has the meaning set forth in
Section 2.4.
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
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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.
1.23 "RESEARCH INSTITUTION" 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
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-
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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.
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 Joydeep Basu; and the Gene-Cell representatives shall initially be
Brian Davis and Judith Yannariello-Brown. 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.
(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
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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
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forth in Exhibit B (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
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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 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
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expressly provided and permitted for the specific purposes for which the license
is granted, and for no other purpose.
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
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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.
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;
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(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.
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
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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
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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.
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
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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 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.
110 Hercules Avenue
Houston, Texas 77058
Attn: President
Fax No.: (281) 461-7408
If to Athersys: Athersys, Inc.
3201 Carnegie Avenue
Cleveland, Ohio 44115-2634
Attn: President
Fax No.: (216) 361-9495
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.
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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.
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.
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IN WITNESS WHEREOF, Gene-Cell and Athersys have executed this Agreement
by their respective duly authorized representatives.
GENE-CELL, INC. ATHERSYS, INC.
By: /s/ Brian R. Davis By: /s/ Gil Van Bokkelen
-------------------------------------- ------------------------------
Print Name: /p/ Brian R. Davis Print Name: /p/ Gil Van Bokkelen
------------------------------ ----------------------
Title: President & CEO Title: President & CEO
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17.