1
EXHIBIT 10.19
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
THIS AGREEMENT entered into on this the 21st day of September, 2000,
(hereinafter "Execution Date") between the BOARD OF TRUSTEES OF THE UNIVERSITY
OF ALABAMA FOR THE UNIVERSITY OF ALABAMA AT BIRMINGHAM having its principal
place of business at 701 20th Street South, Room 1030, Birmingham, Alabama
35294-0111 (hereinafter "UAB") and THE UAB RESEARCH FOUNDATION (hereinafter
"UABRF") having its principal place of business at 701 20th Street South, Room
1120G, Birmingham, Alabama 35294-0111 (hereinafter "UABRF") and ATHERSYS, INC.,
having its principal place of business at 3201 Carnegie Avenue, Cleveland, Ohio
44115 (hereinafter "ATHERSYS").
BACKGROUND
WHEREAS, UAB, and in particular, Dr. Lawrence J. DeLucas, (hereinafter
"Dr. DeLucas"), a faculty member at UAB, in the Center for Biophysical Science
and Engineering, formerly known as the Center for Macromolecular
Crystallography, in conjunction with ATHERSYS are interested in sustaining
research in the development of materials/ideas pertaining to the use and
application of high-throughput screening for macromolecule crystallization
screens, protein expression and purification; and
WHEREAS, ATHERSYS has developed materials/ideas pertaining to the use
and application of producing human proteins, or proteins from other species
based upon the ATHERSYS RAGE process; and
WHEREAS, UAB and ATHERSYS shall provide personnel, operating expenses,
equipment and other support services necessary for the operation of the
identified cooperative research as defined herein below pursuant to attachment
titled "Research Plan"; and
WHEREAS, the Research and Development Program contemplated by this
Agreement is of mutual interest to UAB, UABRF and ATHERSYS and furthers the
educational, scholarship and research objectives of UAB as an educational
institution.
NOW THEREFORE, in consideration of the premises and mutual covenants
contained herein and intending to be legally bound hereby, the parties hereto
agree as follows:
ARTICLE 1. INTRODUCTION
This Cooperative Research and Development Agreement (hereinafter "CRADA")
between UAB, UABRF and ATHERSYS will be effective when signed by all parties.
The research and development project(s), which will be undertaken by each of the
Parties in the course of this CRADA, are detailed in the Research Plan (RP)
which is attached as Appendix B.
2
ARTICLE 2. DEFINITIONS
As used in this CRADA, the following terms shall have the indicated meanings:
2.1 "Cooperative Research and Development Agreement" or "CRADA" means this
Agreement.
2.2 "Parties" means UAB, UABRF and ATHERSYS.
2.3 "Proprietary/Confidential Information" means confidential scientific,
business or financial information which derives economic value from not
being known by the general public or which would constitute a trade
secret under the U.S. Uniform Trade Secrets Act, provided that such
information does not include:
2.3.1 information that is publicly known or available from other
sources who are not under a confidentiality obligation to the
source of the information;
2.3.2 information which has not been made available by its owners to
others without a confidentiality obligation;
2.3.3 information which is already known by or available to the
receiving Party without a confidentiality obligation; or
2.3.4 information which relates to potential hazards or cautionary
warnings associated with the production, handling or use of
the subject matter of the Research Plan of this CRADA.
2.4 "Subject Data" means all recorded information produced during the
performance of this CRADA.
2.5 "Research Materials" means all tangible materials other than Subject
Data first produced in the performance of this CRADA.
2.6 "Subject Invention" means any invention, conceived or first actually
reduced to practice as a result of the performance of research under
this CRADA, that is or may be patentable under 35 U.S.C.(beta)101
or(beta) 161, protectable under 7 U.S.C.(beta)2321, or otherwise
protectable by other types of U. S. or foreign "Intellectual Property"
("IP") rights.
2.7 "Government" means the U.S. Government and any of its agencies.
2.8 "Research Plan" or "RP" means the statement in Appendix B of the
respective research and development commitments of the Parties to this
CRADA.
3
2.9 "Principal Investigator(s)" or "PIs" means the persons designated
respectively by the Parties to this CRADA who will be responsible for
the scientific and technical conduct of the RP.
2.10 "Research License" shall mean a nontransferable, nonexclusive license
to make and use a licensed invention for purposes of research including
human clinical trials and not for purposes of commercial manufacture or
distribution or in lieu of purchase if licensed products or licensed
processes are marketed by licensee as research tools.
ARTICLE 3. COOPERATIVE RESEARCH
3.1 Research Team. The Parties agree to establish a joint research and
development team (hereinafter referred to as the "Team") comprising at
least the Principal Investigators designated pursuant to Article 3.3 to
conduct and monitor the research in accordance with the RP. Although
the members of the Team shall be considered as having been delegated to
the Team, they shall continue to remain employed by their respective
employers under their respective terms of employment.
3.2 Review of Work. Quarterly conferences (or according to such other
schedule as the Parties may agree) shall be held by the Team to review
work progress. It is understood that the nature of this cooperative
research precludes a guarantee of its completion within the specified
period of performance or limits of allocated financial or staffing
support. Accordingly, research under this CRADA is to be performed on a
best efforts basis.
3.3 Principal Investigators. UAB research work under this CRADA will be
performed by the Center for Biophysical Science and Engineering
(hereinafter "CBSE") identified in the RP, and the UAB Principal
Investigator (PI) designated in the RP will be responsible for the
scientific and technical conduct of this project on behalf of UAB. Also
designated in the RP is the ATHERSYS PI who will be responsible for the
scientific and technical conduct of this project on behalf of ATHERSYS.
3.4 Research Plan Change. The RP may be modified by mutual written consent
of the Principal Investigators. Material changes in the scope of the RP
will be treated as amendments under Article 14.6.
ARTICLE 4. REPORTS
4.1 Interim Reports. The Parties shall exchange formal written interim
progress reports on a quarterly basis. Such reports shall set forth the
technical progress
4
made, identifying such problems as may have been encountered and
establishing goals and objectives requiring further effort.
4.2 Final Reports. The Parties shall exchange final reports of their
results within four (4) months after completing the projects described
in the RP or after the termination of this CRADA.
ARTICLE 5. FINANCIAL OBLIGATIONS
5.1 Cost incurred by the Parties. Each Party shall be responsible for its
own costs incurred and associated with fulfilling its respective
research obligations under this CRADA.
5.2 Accounting Records. UAB and ATHERSYS shall maintain separate and
distinct current accounts, records, and other evidence supporting all
its obligations under this CRADA, and shall provide an annual report
reflecting the use of funds and a final such fiscal report at the time
that final reports are exchanged pursuant to Article 4.2. The Parties
shall keep these records for the purpose of obtaining reimbursement for
work expenses incurred during the collaboration in the event of an
assignment, sublicensing or transfer agreement of Subject Inventions to
a third party.
ARTICLE 6. TITLE TO PROPERTY
6.1 Capital Equipment. The purchase or use of capital equipment to carry
out this CRADA does not affect the ownership rights that would
otherwise apply. All capital equipment provided under this CRADA by one
party for the use of another Party remains the property of the
providing Party unless other disposition is mutually agreed upon by in
writing by the PIs. If title to this equipment remains with the
providing Party, that Party is responsible for maintenance of the
equipment and the costs of its transportation to and from the site
where it will be used.
ARTICLE 7. INTELLECTUAL PROPERTY RIGHTS AND PATENT APPLICATIONS
7.1 Reporting. The Parties shall promptly report to each other in writing
each Subject Invention resulting from the research conducted under this
CRADA within thirty (30) days of said Subject Invention being disclosed
to the appropriate Party representative. Such reports shall be treated
in confidence by the receiving Party subject to Article 9. Because of
the royalty sharing provisions for inventors under the UAB Intellectual
Property Policy as well as UAB's obligations under to report all
inventions under the Federal Technology Transfer Act of 1986, and in
view of
5
Article 8.4 of this CRADA which grants UAB only a research license for
noncommercial purposes to Subject Inventions, ATHERSYS acknowledges a
special duty to report all Subject Inventions to UAB so that UAB may
determine whether or not inventorship properly includes UAB
investigators.
7.2 ATHERSYS Employee Inventions. Each Subject Invention made solely by
ATHERSYS shall be solely owned by ATHERSYS.
7.3 UAB Employee Inventions. Each Subject Invention made solely by UAB
shall be solely owned by UAB.
7.4 Joint Inventions. Each Subject Invention made jointly by UAB and
ATHERSYS employees shall be jointly owned by UABRF and ATHERSYS.
7.5 Filing of Patent Applications. (A) Separate Technology. Each Party
shall retain control over and bear all expenses associated with the
filing, prosecution, and maintenance of all patents related to that
Party's rights pursuant to Articles 7.2 or 7.3, as the case may be, in
the Subject Inventions; provided, however, if ATHERSYS instructs UABRF
to file a patent to protect a UAB Employee invention, then the expenses
will be born by ATHERSYS. (B) Joint Technology. With respect to Subject
Inventions made jointly by UAB and ATHERSYS as described in Article
7.4, each Party agrees to cooperate in order to file a patent or other
IP applications in a timely manner and the expense shall be born
equally by UAB and ATHERSYS, unless otherwise agreed in writing. The
Team shall supervise and direct the filing, prosecution and maintenance
of all such Subject Inventions, including selection of outside counsel,
reasonably acceptable to the Parties, to handle such filing,
prosecution, and maintenance. The Team shall provide each Party with
(i) drafts of any new patent application that covers inventions in such
Subject Invention prior to filing that application, allowing adequate
time for review and comment by the Party if possible; and (ii) copies
of all correspondence from any and all patent offices concerning patent
applications covering such Subject 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.
7.6 Patent Expenses for ATHERSYS' License. If an exclusive license to any
Subject Invention is granted to ATHERSYS, ATHERSYS shall reimburse UAB
for the reasonable past and ATHERSYS-approved ongoing funds expended
worldwide for filing, prosecuting and maintaining any applications
claiming such exclusively-licensed inventions and any patents or other
IP grants that may issue on such applications which UAB has expended to
protect the IP rights exclusively licensed to ATHERSYS. ATHERSYS may
waive its exclusive license rights on any application, patent or other
IP grant at any time, and incur no subsequent compensation obligation
for that application, patent or IP grant.
6
7.7 Prosecution of Intellectual Property Applications. Each Party shall
provide the other Party with copies of the applications it files on any
Subject Invention along with the power to inspect and make copies of
all documents retained in the patent or other IP application files by
the applicable patent or other IP office. The Parties agree to consult
with each other with respect to the prosecution of all Subject
Inventions.
7.8 Enforcement of Patent Rights. (i) 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
and/or rights to the Subject Invention under Article 7.2 or 7.3, as the
case may be. (ii) If either Party becomes aware of conduct by a third
party that potentially infringes one or more patents claiming the
rights to the Subject Invention that is owned jointly under Article
7.4, 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 UABRF to
terminate any such infringement. If only one Party takes such legal
action at its sole cost, that Party shall be entitled to reimbursement
of all reasonable direct cost arising from the legal action and the
remainder of said damages awarded or settlement paid as a result of
such legal action shall be allocated to reflect the percentage of the
royalty payment(s) payable under the license agreement for the patent
the basis for the 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.
7.9 Election Not to Prosecute. If either Party elects not (i) to pursue the
filing, prosecution, or maintenance of a Subject Invention in a
particular country, or (ii) to take any other action with respect to a
Subject Invention in a particular country that is necessary or
reasonably useful to establish or preserve rights thereto, then in each
such case such Party shall so notify the other Party promptly in
writing and in good time to enable such other Party to meet any
deadlines by which an action must be taken to establish or preserve any
such rights in such joint Subject Invention, as applicable, in such
country. Upon receipt of each such notice by such other Party or if, at
any time, such Party fails to initiate any such action within thirty
(30) days after a request by such other Party that it do so (and
thereafter diligently pursue such action), such other Party shall have
the right, but not the obligation, to pursue the filing or
registration, or support the continued prosecution or maintenance, of
such Subject Invention at its expense in such country. If such other
Party elects to pursue such filing or registration, as the case may be,
or continue such support, then such other Party shall notify such Party
of such election and such Party shall, and cause its affiliates to (x)
reasonably cooperate with such other Party in this regard, and (y)
promptly release or assign to such other Party, all right, title, and
interest in and to such Subject Invention, in
7
such country as to UAB to extent the Patent Policy of UAB does not
prohibit said release or assignment.
ARTICLE 8. LICENSING
8.1 Option for Exclusive Commercialization License. With respect to rights
to any Subject Invention not made solely by ATHERSYS' employees for
which a patent or other IP application is filed, UABRF hereby grants to
ATHERSYS an option to negotiate, in good faith, the terms of an
exclusive or nonexclusive commercialization license that fairly
reflects the relative contributions of the Parties. The license will
specify the licensed fields of use and other applicable terms and
obligations. Exclusive licensees will be expected to reimburse UAB as
well as its operating unit CBSE or UABRF for IP expenses related to
each licensed intellectual property.
8.2 Exercise of License Option. The option of Article 8.1 must be exercised
by written notice mailed within six (6) months after disclosure in
writing of Subject Invention to ATHERSYS. Exercise of this option by
ATHERSYS initiates a negotiation period that expires six (6) months
after the patent or other IP application filing date. If UABRF and
ATHERSYS are unable to come to terms during the initial six (6) month
period, UABRF will be free to negotiate a license covering a UAB
Invention to a third party. If UAB and ATHERSYS are unable to come to
terms during the initial six month period, UABRF will be free to
negotiate a license covering a UAB Invention to a third party.
Notwithstanding the above, Article III of the MTA, as herein defined,
shall govern the rights of ATHERSYS as to the fifty (50) proteins
contemplated to be transferred to UAB under the MTA.
8.3 UAB Intellectual Property Rights. For Subject Inventions developed by
UAB investigators or jointly with ATHERSYS, under this CRADA, pursuant
to Articles 7.3 and 7.4, UAB is required to retain at least a
nonexclusive, irrevocable, paid-up license to practice the invention or
to have the invention practiced by UAB and its subsidiaries,
affiliates, Health Services Foundation, Health System, UAB Hospital for
noncommercial and patient care purposes only.
8.4 Research Licenses. For Subject Inventions developed under this CRADA,
pursuant to Article 7.3 and 7.4, ATHERSYS agrees to grant UAB a
Research License for noncommercial purposes only.
8.5 Joint Inventions not Exclusively Licensed. In the event that ATHERSYS
does not acquire an exclusive commercialization license (pursuant to
Article 8.1 and 8.2) to IP rights in joint Subject Inventions described
in Article 7.4, then each Party shall have the right to use the joint
Subject Invention and to license its use to others. The Parties may
agree to a joint licensing approach for such IP rights.
8
ARTICLE 9. PROPRIETARY RIGHTS AND PUBLICATION
9.1 Right of Access. UAB and ATHERSYS agree to exchange all Subject Data
produced in the course of research under this CRADA, whether developed
solely by UAB, ATHERSYS, or jointly. Research Materials will be shared
equally by the Parties to the CRADA unless other disposition is agreed
to by the Parties. All Parties to this CRADA will be free to utilize
Subject Data and Research Materials for their own purposes, consistent
with their obligations under this CRADA.
9.2 Ownership of Subject Data and Research Materials. Subject to the
sharing requirements of Paragraph 9.1, the producing Party will retain
ownership of and title to all Subject Inventions, all Subject Data and
all Research Materials produced solely by their investigators. Jointly
developed Subject Inventions, Subject Data and Research Materials will
be jointly owned and Intellectual Property sharing agreements (i.e.
inventors percent contribution) shall be negotiated on a fair and
equitable basis. Notwithstanding the foregoing, all RAGE technology,
including RAGE libraries, RAGE cell lines, genes identified through the
use of such RAGE cell lines, any protein expression constructs or any
derivative material generated by ATHERSYS or UAB from RAGE Technology,
and any proteins produced through the use of the RAGE Technology shall
remain the sole and exclusive property of ATHERSYS (collectively
"ATHERSYS Materials") and are subject to potential intellectual
property rights of UAB employees as determined under U.S. Patent Law.
9.3 Dissemination of Subject Data and Research Materials. To the extent
allowed under law, UAB agrees to use the same degree of care as UAB
uses for its own proprietary/confidential information to keep Subject
Data and Research Materials confidential, until published or until
corresponding patent applications are filed. UAB may delay disclosure
of Subject Data for a reasonable time in order for patent applications
to be filed. Generally, UAB will not further limit disclosure of
Subject Data or Research Materials.
9.4 Proprietary/Confidential Information. Each Party agrees to limit its
disclosure of Proprietary/Confidential Information to the amount
necessary to carry out the Research Plan of this CRADA, and shall place
a confidentiality notice on all such information. Each Party receiving
Proprietary/Confidential Information agrees that any information so
designated shall be used by it only for the purposes described in the
attached Research Plan. Any Party may object to the designation of
information as Proprietary/Confidential Information by another Party
and may decline to accept such information. Data and research materials
developed solely by ATHERSYS may be designated as
Proprietary/Confidential Information when they are wholly separable
from the Subject Data and Research Materials developed under this
Agreement, and advance designation of such data and material categories
is set forth in the RP. The exchange of other confidential information,
e.g., patient data, should be similarly limited and treated.
9
9.5 Protection of Proprietary/Confidential Information. Each Party agrees
to use its best efforts to maintain the confidentiality of
Proprietary/Confidential Information. Each Party agrees that another
Party is not liable for the disclosure of Proprietary/Confidential
Information which, after notice to and consultation with the concerned
Party, another Party in possession of the Proprietary/Confidential
Information determines may not lawfully be withheld, provided the
concerned Party has been given an opportunity to obtain a court order
to enjoin disclosure.
9.6 Duration of Confidentiality Obligation. The obligation to maintain the
confidentiality of Proprietary/Confidential Information shall expire at
the earlier of the date when the information is no longer Proprietary
Information defined in Article 2.3 or three (3) years after the
expiration or termination date of this CRADA. ATHERSYS may request an
extension to this term when necessary to protect
Proprietary/Confidential Information relating to products not yet
commercialized.
9.7 Publication. The Parties are encouraged to make publicly available the
results of their research. Before either Party submits a paper or
abstract for publication or otherwise intends to publicly disclose
information about a Subject Invention, Subject Data or Research
Materials, the other Party shall be provided thirty (30) days to review
the proposed publication or disclosure to assure that
Proprietary/Confidential Information is protected. The publication or
other disclosure shall be delayed for up to (thirty) 30 additional days
upon written request by any Party as necessary to preserve U. S. or
foreign patent or other IP rights.
9.8 Disclosure. Notwithstanding the obligations in Articles 9.4, 9.5, 9.6,
and 9.7, a Party may disclose the Proprietary/Confidential Information
of the other Party to the extent such disclosure is (i) made in
response to a valid order of a court of competent jurisdiction; (ii)
otherwise required by regulation or law; (iii) made by such Party to
any applicable federal, national, regional, state, or local regulatory
agencies, departments, bureaus, commissions, councils, or other
governmental entities; (iv) made by such Party, in connection with the
performance of this Agreement, to affiliates, permitted sublicensees,
research collaborators, employees, consultants, or agents (each of whom
must, prior to such disclosure, be required to be bound by the
confidentiality obligations of this Agreement); and (v) made by such
Party to existing or potential investment bankers, investors, and/or
merger and acquisition parties (each of whom must, prior to such
disclosure, be required to be bound by the confidentiality obligations
of this Agreement). If a Party is required to make any disclosure of
another Party's Proprietary/Confidential Information pursuant to
subsection (i), (iv), or (v), then it will give the other Party advance
notice of such disclosure and will use its reasonable efforts to secure
confidential treatment of such disclosure.
10
ARTICLE 10. REPRESENTATIONS AND WARRANTIES
10.1 Representations and Warranties of UAB and UABRF. UAB and UABRF hereby
represent and warrant to ATHERSYS that (i) each is a corporation duly
organized validly existing and in good standing under the laws of the
state of its respective incorporation; (ii) each has all requisite
power and authority to enter into this Agreement and to consummate the
transactions contemplated by this Agreement; (iii) the execution and
delivery of this Agreement and the consummation of the transactions
contemplated hereby have been duly authorized by all necessary
corporate action on the part of each UAB and UABRF; and (iv) this
Agreement has been duly executed and delivered by UAB and UABRF and
constitute the legal, valid and binding obligations of each UAB and
UABRF enforceable against it in accordance with their terms.
10.2 Representations and Warranties of the ATHERSYS. ATHERSYS hereby
represents and warrants to UAB and UABRF that (i) it is a corporation
duly organized validly existing and in good standing under the laws of
the State of Delaware; (ii) it has all requisite power and authority to
enter into this Agreement and to consummate the transactions
contemplated by this Agreement; (iii) the execution and delivery of
this Agreement and the consummation of the transactions contemplated
hereby have been duly authorized by all necessary corporate action on
the part of ATHERSYS; and (iv) this Agreement has been duly executed
and delivered by ATHERSYS and constitute the legal, valid and binding
obligations of ATHERSYS enforceable against it in accordance with their
terms.
ARTICLE 11. TERMINATION
11.1 Termination By Mutual Consent. UAB and ATHERSYS may terminate this
CRADA, or portions thereof, at any time by mutual written consent. In
such event the Parties shall specify the disposition of all property,
inventions, patent or other IP applications and other results of work
accomplished or in progress, arising from or performed under this
CRADA.
11.2 Unilateral Termination. Either UAB or ATHERSYS may unilaterally
terminate this entire CRADA at any time by giving written notice at
least thirty (30) days prior to the desired termination date, and any
rights accrued in property, patents or other IP rights shall be
disposed of as provided in paragraph 11.1. In the event of a unilateral
termination by either Party, then all ATHERSYS Materials in the
possession of UAB shall be promptly returned to ATHERSYS. In the event
that UAB transfers Research Material to ATHERSYS that is the sole and
exclusive property of UAB, then upon termination by either Party, such
material shall be promptly returned to UAB by ATHERSYS.
11
11.3 New Commitments. No Party shall make new commitments related to this
CRADA after a mutual or unilateral termination and shall, to the extent
feasible, cancel all outstanding commitments and contracts by the
termination date.
11.4 Termination Costs. The Parties agree that upon termination by either
party that the Parties shall within a reasonable time after termination
to submit to each other for payment a statement of all reasonable costs
incurred prior to the date of termination, including the cost of
returning property or removal of abandoned property as well as any
patent expenses.
ARTICLE 12. DISPUTES
12.1 Settlement. Any dispute arising under this CRADA, which is not disposed
of by agreement of the Principal Investigators, shall be submitted
jointly to the signatories of this CRADA to jointly resolve the dispute
within thirty (30) days after notification thereof. Nothing in this
article shall prevent any Party from pursuing any and all
administrative and/or judicial remedies which may be available.
12.2 Continuation of Work. Pending the resolution of any dispute or claim
pursuant to this Article, the Parties agree that performance of all
obligations shall be pursued diligently in accordance with the mutually
agreed upon and joint direction of ATHERSYS' PI and UAB'S PI.
ARTICLE 13. LIABILITY
13.1 Property. UAB shall not be responsible for damages to any property of
ATHERSYS provided to it or acquired by it pursuant to this CRADA.
13.2 NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 10, THE PARTIES
MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER,
INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR PRODUCT,
WHETHER TANGIBLE OR INTANGIBLE, MADE, OR DEVELOPED UNDER THIS CRADA, OR
THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF
THE RESEARCH OR ANY INVENTION OR PRODUCT.
13.3 Indemnification. ATHERSYS agrees to hold the UAB and UABRF harmless and
to indemnify UAB and UABRF for all liabilities, demands, damages,
expenses and losses arising out of the use by ATHERSYS for any purpose
of the Subject Data, Research Materials and/or Subject Inventions
produced in whole or part by
12
UAB employees under this CRADA, unless due to the negligence of UAB or
UABRF, its employees, or agents. ATHERSYS shall be liable for any
claims or damages it incurs in connection with this CRADA. UAB has no
authority to indemnify ATHERSYS under Alabama State Law.
13.4 Force Majeure. Neither Party shall be liable for any unforeseeable
event beyond its reasonable control not caused by the fault or
negligence of such Party, which causes such Party to be unable to
perform its obligations under this CRADA, and which it has been unable
to overcome by the exercise of due diligence. In the event of the
occurrence of such a force majeure event, the Party unable to perform
shall promptly notify the other Party. It shall further use its best
efforts to resume performance as quickly as possible and shall suspend
performance only for such period of time as is necessary as a result of
the force majeure event.
ARTICLE 14. MISCELLANEOUS
14.1 Governing Law. The construction, validity, performance and effect of
this CRADA shall be governed by the Laws of the State of Alabama in the
Northern District of Alabama.
14.2 Entire Agreement. This CRADA and the Materials Transfer Agreement,
dated as of September 20, 2000 between the Parties (the "MTA")
constitutes the entire agreement between the Parties concerning the
subject matter of this CRADA and supersedes any prior understanding or
written or oral agreement. In the event this CRADA contains terms or
provisions, which conflict with or are inconsistent with the MTA, the
terms of this CRADA shall govern, except where indicated in Article
8.2.
14.3 Headings. Titles and headings of the articles and subarticles of this
CRADA are for the convenience of reference only, do not form a part of
this CRADA and shall in no way affect its interpretation.
14.4 Waivers. None of the provisions of this CRADA shall be considered
waived by any Party unless such waiver is given in writing to the other
Party. The failure of a Party to insist upon strict performance of any
of the terms and conditions hereof, or failure or delay to exercise any
rights provided herein or by law, shall not be deemed a waiver of any
rights of any Party.
14.5 Severability. The illegality or invalidity of any provisions of this
CRADA shall not impair, affect or invalidate the other provisions of
this CRADA.
14.6 Amendments. If either Party desires a modification to this CRADA, the
Parties shall, upon reasonable notice of the proposed modification or
extension by the Party desiring the change, confer in good faith to
determine the desirability of such modification or extension. Such
modification shall not be effective until a
13
written amendment is signed by the signatories to this CRADA or by
their representatives duly authorized to execute such amendment.
14.7 Assignment. Neither this CRADA nor any rights or obligations of any
Party hereunder shall be assigned or otherwise transferred by either
Party without the prior written consent of the other Party.
14.8 Notices. All notices pertaining to or required by this CRADA shall be
in writing and shall be signed by an authorized representative and
shall be delivered by hand or sent by certified mail, return receipt
requested, with postage prepaid, to the addresses indicated on the
signature page for each Party. Notices regarding the exercise of
license options shall be made pursuant to Article 8.2. Any Party may
change such address by notice given to the other Party in the manner
set forth above.
14.9 Independent Contractors. The relationship of the Parties to this CRADA
is that of independent contractors and not as agents of each other or
as joint venturers or partners. Each Party shall maintain sole and
exclusive control over its personnel and operations. ATHERSYS employees
who will be working at UAB facilities may be asked to sign a Guest
Researcher or some other type of agreement appropriately drafted in
view of the terms of this CRADA.
14.10 Use of Name or Endorsements. By entering into this CRADA, UAB does not
directly or indirectly endorse any product or service provided, or to
be provided, whether directly or indirectly related to either this
CRADA or to any patent or other IP license or agreement which
implements this CRADA by its successors, assignees, or licensees.
ATHERSYS shall not in any way state or imply that this CRADA is an
endorsement of any such product or service by UAB or any of its
organizational units or employees. Unless required by law, the use of
the name, The University of Alabama at Birmingham or the name of any
campus of the University of Alabama is expressly prohibited without
prior written approval, except for filings with the SEC or required by
law. Prior to public domain publication, UAB and ATHERSYS shall
mutually agree upon the text of any publication as to the relationship
of the Parties under this CRADA or the MTA.
14.11 Reasonable Consent. Whenever a Party's consent or permission is
required under this CRADA, such consent or permission shall not be
unreasonably withheld.
ARTICLE 15. DURATION OF AGREEMENT
15.1 Duration. It is mutually recognized that the duration of this project
cannot be rigidly defined in advance, and that the contemplated time
periods for various phases of the RP are only good faith guidelines
subject to adjustment by mutual agreement to fit circumstances as the
RP proceeds. In no case will the term of
14
this CRADA extend beyond the term indicated in the RP unless it is
revised in accordance with Article 14.6.
15.2 Survivability. The provisions of Articles 4.2, 5.2, 5.3, 6.1, Articles
7-9, 11.3-11.5, 11.5, 12.1, 13.2-13.4, 14.1, 14.10 and 15.2 shall
survive the termination of this CRADA.
[END OF PAGE]
15
CRADA SIGNATURE PAGE
FOR UAB:
/s/ Peter V. O'Neil 9/20/2000
- --------------------------------------- -------------------------
Date
Peter V. O'Neil, Provost
- -------------------------------------------------------------------------
Mailing Address for Notices:
701 20th Street South
- -------------------------------------------------------------------------
Birmingham, Alabama 35205
- -------------------------------------------------------------------------
FOR UABRF:
/s/ Peter V. O'Neil 9/20/2000
- ---------------------------------------
Date
Peter V. O'Neil, Provost
- --------------------------------------- -------------------------
- -------------------------------------------------------------------------
Mailing Address for Notices:
701 20th Street South, AB-1120
- -------------------------------------------------------------------------
Birmingham, Alabama 35205
- -------------------------------------------------------------------------
FOR ATHERSYS:
/s/ Gil Van Bokkelen 9/25/00
- --------------------------------------- -------------------------
Date
/p/ Gil Van Bokkelen, President and Chief Executive Officer
- -------------------------------------------------------------------------
Mailing Address for Notices:
3201 Carnegie Avenue
- -------------------------------------------------------------------------
Cleveland, Ohio 44115-2634
- -------------------------------------------------------------------------