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Exhibit 10.11
CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
LICENSE AGREEMENT
BETWEEN
ATHERSYS, INC
AND
ATHERSYS NEWCO LTD.
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TABLE OF CONTENTS
1. DEFINITIONS.............................................................3
2. ATHERSYS LICENSE TO NEWCO..............................................11
3. SUBSTITUTE INDICATIONS/PRODUCTS........................................12
4. INTELLECTUAL PROPERTY..................................................12
5. AFTER ACQUIRED TECHNOLOGY..............................................15
6. FINANCIAL PROVISIONS...................................................15
7. RIGHT OF INSPECTION AND AUDIT..........................................16
8. REPRESENTATIONS AND WARRANTIES.........................................17
9. TERM AND TERMINATION...................................................19
10. CONFIDENTIAL INFORMATION...............................................21
11. GOVERNING LAW AND JURISDICTION.........................................23
12. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE...........................23
13. ASSIGNMENT.............................................................23
14. NOTICES................................................................24
15. MISCELLANEOUS..........................................................25
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THIS LICENSE AGREEMENT is made and entered into as of this 21st day of October
1999
BY AND BETWEEN:
(1) ATHERSYS, INC., a Delaware corporation having its principal place of
business at 11000 Cedar Avenue, Cleveland, Ohio 44106; and
(2) ATHERSYS NEWCO LTD., a Bermuda exempted limited liability company
incorporated under the laws of Bermuda and having its registered office
at Clarendon House, Church St., Hamilton, Bermuda.
RECITALS:
A. Simultaneously herewith, Athersys, Elan, EIS, and Newco (capitalized
terms used herein are defined below) are entering into the JDOA which
establishes inter alia, the terms and conditions of the joint venture
and of regulating their relationship with each other and certain
aspects of the affairs of, and their dealings with Newco.
B. Newco desires to enter into this Agreement with Athersys so as to
permit Newco to utilize the Athersys Intellectual Property in making,
having made, importing, using, offering for sale and selling the
Product for use in the Field in the Territory.
C. Simultaneously herewith Newco and Athersys are entering into the
Athersys License Agreement relating to Newco's use of the Athersys
Intellectual Property.
Now, Therefore, the Parties agree as follows:
1. DEFINITIONS
As used in this Agreement, the following capitalized terms shall have
the following meanings. Capitalized terms used in this Agreement and
not otherwise defined in this Clause 1 or elsewhere in this Agreement
shall have the meanings ascribed to such terms in the JDOA or the Elan
License Agreement, as applicable.
1.1. "AFFILIATE" shall mean with respect to Elan or Athersys, any
corporation or entity other than Newco (and entities controlled by it)
controlling, controlled by or under the common control of Elan or
Athersys, as the case may be, and, with respect to Newco, any
corporation or entity under control of Newco. For the purpose of this
definition, "control" shall mean (a) direct or indirect ownership of
fifty percent (50%) or more of the stock or shares entitled to vote for
the election of directors, or (b) the actual ability to control and
direct the management of the applicable entity.
1.2. "AGREEMENT" shall mean this License Agreement (which expression shall
be deemed to include the Recitals and Schedules hereto).
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1.3. "ATHERSYS" shall mean Athersys, Inc., a Delaware corporation having its
principal place of business at 11000 Cedar Avenue, Cleveland, Ohio
44106, its successors and permitted assigns.
1.4. "ATHERSYS IMPROVEMENTS" shall mean any improvements to the Athersys
Know-How and/or the Athersys Patent Rights developed (a) by or on
behalf of Athersys whether or not pursuant to the Project, (b) by
Newco, or by Elan or any third party under contract with Newco,
pursuant to the Project, and/or (c) jointly by any combination of
Athersys, Elan or Newco pursuant to the Project. Except as limited by
agreements with independent third parties in existence at any time
during the term of the Athersys License, Athersys Improvements shall be
deemed part of and shall be included in the term "Athersys Intellectual
Property" and shall be deemed, immediately upon development, to be
included in the license of the Athersys Intellectual Property granted
to Newco hereunder. If the inclusion of an Athersys Improvement in the
license of Athersys Intellectual Property granted to Newco hereunder is
restricted or limited by a third party agreement, then Athersys shall
use reasonable commercial efforts to exclude or where applicable to
minimize any such restriction or limitation.
1.5. "ATHERSYS INTELLECTUAL PROPERTY" shall mean the Athersys Improvements,
Athersys Know-How and/or the Athersys Patent Rights.
1.6. "ATHERSYS KNOW-HOW" shall mean Know-How that is Controlled by Athersys
and relates to the Selected Protein produced using RAGE.
1.7. "ATHERSYS LICENSE" shall mean have the meaning as such term is defined
in Clause 2.1 of this Agreement.
1.8. "ATHERSYS PATENT RIGHTS" shall mean any and all Patent Rights that are
Controlled by Athersys relating to the Selected Protein produced using
RAGE. The primary examples of the Athersys Patent Rights existing as of
the date hereof are set forth on Schedule 1, which listing is not
necessarily exhaustive.
1.9. "ATHERSYS TRADEMARK(S)" shall mean if requested by Newco, one or more
trademarks, trade names, or service marks that are owned or licensed by
or on behalf of Athersys that Athersys may nominate and approve in
writing from time to time for use in connection with the sale or
promotion of the Product by Newco.
1.10. "BOLUS DRUG DELIVERY SYSTEM" shall mean Elan's bolus drug delivery
system having a drug reservoir volume of up to 1 ml. and a delivery
rate of between 1 second and 1 hour, embodiments of which are disclosed
in the Elan Patent Rights.
1.11. "BUSINESS PLAN" shall have the meaning, as such term is defined in the
JDOA.
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CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
1.12. [***](1)
1.13. "COMMERCIALIZATION" shall mean the manufacture, have manufactured,
promotion, distribution, import, use, marketing and sale of the Product
in accordance with the terms of this Agreement.
1.14. "CONFIDENTIAL INFORMATION" shall have the meaning, as such term is
defined in Clause 10.
1.15. "CONTINUOUS DRUG DELIVERY SYSTEM" shall mean Elan's ambulatory,
micro-infusion system, having a flexible drug reservoir and capable of
delivering pre-programmed continuous amounts of drug upon activation,
embodiments of which are disclosed in Elan Patent Rights.
1.16. "CONTROLLED" shall mean, with respect to a particular item of
information, material or intellectual property right, that the
applicable Party owns or has a license to such item of information,
material or intellectual property right and has the ability to grant to
the other Party access to and a license or sublicense under such item
as contemplated herein.
1.17. "EFFECTIVE DATE" shall mean the date of this Agreement as set forth in
the first line of the Agreement.
1.18. "EIS" shall mean Elan International Services, Limited, a Bermuda
exempted limited liability company incorporated under the laws of
Bermuda and having its registered office at Clarendon House, Church
St., Hamilton, Bermuda, and wholly-owned by Elan, plc.
1.19. "ELAN" shall mean Elan, plc and EPIL, and their respective successors
and permitted assigns.
1.20. "ELAN, PLC" shall mean Elan Corporation, plc, a public limited company
incorporated under the laws of Ireland acting through its division Elan
Pharmaceutical Technologies.
1.21. "ELAN IMPROVEMENTS" shall have the meaning as such term is defined in
the Elan License Agreement.
1.22. "ELAN INTELLECTUAL PROPERTY" shall have the meaning as such term is
defined in the Elan License Agreement.
1.23. "ELAN LICENSE" shall have the meaning set forth in Clause 2.1 of the
Elan License Agreement.
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(1) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
1.24. "ELAN LICENSE AGREEMENT" shall mean that certain License Agreement, of
even date herewith, entered into between Athersys and Newco.
1.25. "EPIL" shall mean Elan Pharma International Limited, a private limited
company incorporated under the laws of Ireland that is wholly-owned by
Elan, plc.
1.26. "FIELD" shall mean the subcutaneous administration of the Selected
Protein produced using RAGE via the MEDIPAD(R) Drug Delivery System to
treat the Selected Indication.
1.27. "FINANCIAL YEAR" shall mean each year commencing on 1 January (or in
the case of the first Financial Year, the Effective Date) and expiring
on 31 December of each year.
1.28. [***](2)
1.29. [***](3)
1.30. "INITIAL INDICATION" shall mean the treatment of [***](4)
1.31. "IN MARKET" shall mean the sale of the Product by Newco or its
Affiliates, or where applicable by a permitted sub-licensee or
distributor, to an unaffiliated third party such as (i) an end-user
consumer of the Product or (ii) a wholesaler, distributor, managed care
organization, hospital or pharmacy or other third party payor for final
commercial sale by such party to the consumer, and shall exclude in any
event the transfer pricing of the Product by Newco to an Affiliate.
1.32. "JDOA" shall mean that certain Subscription, Joint Development And
Operating Agreement, of even date herewith, by and between Elan,
Athersys, EIS and Newco.
1.33. "KNOW-HOW" shall mean any and all information and know-how, whether
patentable or not, including but not limited to discoveries,
inventions, substance, data, techniques, processes, systems,
formulations, designs and commercial information.
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(2) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(3) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(4) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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1.34. "LICENSES" shall mean the Elan License and the Athersys License.
1.35. "MANAGEMENT COMMITTEE" shall have the meaning, as such term is defined
in the JDOA.
1.36. "MEDIPAD(R) DRUG DELIVERY SYSTEM" shall mean the Bolus Drug Delivery
System and/or Continuous Drug Delivery System, as the case may be.
1.37. "NET SALES" shall mean an amount equal to the aggregate gross amount
invoiced to the purchasers for In Market sales of the Products by Newco
and its Affiliates and permitted sub-licensees, less the following
deductions to the extent actually incurred or allowed with respect to
such sales:
(i) transportation charges or allowances, if any, included in such
invoiced price;
(ii) trade, quantity or cash discounts, broker's or agent's
commissions, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account of
price adjustments, returns, bad debts, promotional discounts,
rebates and any and all federal, state or local government
rebates whether in existence now or enacted at any time during
the term of the Licenses; and
(iv) any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Product.
1.38. "NEWCO" shall mean Athersys Newco Ltd., an exempted Bermuda limited
liability company incorporated under the laws of Bermuda by EIS and
Athersys on October 18, 1999 and having its registered office at 102
St. James Court, Flatts, Smiths FL04, Bermuda, its successors and
permitted assigns.
1.39. "NEWCO INTELLECTUAL PROPERTY" shall mean all Newco Program Technology
and all technology licensed or acquired by Newco (other than Elan
Intellectual Property and Athersys Intellectual Property) or developed
by Newco outside of the Project, and all intellectual property rights
in or appurtenant to any of the foregoing.
1.40. "NEWCO PROGRAM TECHNOLOGY" shall mean any and all Program Technology,
excluding all Elan Improvements and all Athersys Improvements.
1.41. "PARTY" shall mean Athersys or Newco, as the case may be, and "PARTIES"
shall mean Athersys and Newco.
1.42. "PATENT RIGHTS" shall mean any and all patents and patent applications,
and all rights therein, and including all extensions, continuations,
continuations-in-part, divisionals, patents-of-additions,
re-examinations, re-issues, supplementary protection certificates
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CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
and foreign counterparts of such patents and patent applications and
any patents issuing thereon and extensions of or supplemental
protection certificates with respect to any patents.
1.43. "PROGRAM TECHNOLOGY" shall mean all Know-How and technology developed
by or on behalf of Newco, whether by Elan, Athersys, a third party or
jointly by any combination thereof, pursuant to the Project;
1.44. "PRODUCT" shall mean the Selected Protein produced using RAGE and
incorporated within or packaged with the MEDIPAD(R) Drug Delivery
System.
1.45. "PROJECT" shall mean all activities undertaken by Newco (and/or by Elan
or Athersys pursuant to a contract with Newco) relating to the
development and Commercialization of the Product for use in the Field
in accordance with the Plan.
1.46. "RAGE" shall mean the technology Controlled by Athersys' related to
randomly activated gene expression techniques.
1.47. "SELECTED INDICATION" shall mean the Initial Indication, unless and
until a Substitute Indication is designated to be the subject of the
Project pursuant to the designation of a Substitute Protein/Indication
under the provisions of Clauses 7.2 and 7.3 of the JDOA, in which case
the term "Selected Indication" shall mean such designated Substitute
Indication.
1.48. "SELECTED PROTEIN" shall mean [***](5), unless and until a Substitute
Protein is designated to be the subject of the Project pursuant to the
designation of a Substitute Protein/Indication under the provisions of
Clauses 7.2 and 7.3 of the JDOA, in which case the term "Selected
Protein" shall mean such designated Substitute Protein.
1.49. "SUBSTITUTE INDICATION" shall mean [***](6)
1.50. "SUBSTITUTE PROTEIN" [***](7)
1.51. "SUBSTITUTE PROTEIN/INDICATION" shall mean either: [***]8 as designated
pursuant to the terms of Clauses 7.2 and 7.3 of the JDOA.
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(5) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(6) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(7) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(8) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
"TECHNOLOGICAL COMPETITOR"
1.52.1 "TECHNOLOGICAL COMPETITOR OF ATHERSYS" shall mean any entity
listed on Schedule 2 hereto, subject to Clause 1.52.3 and
amendment from time to time upon mutual written agreement of
Newco, Athersys and Elan.
1.52.2 "TECHNOLOGICAL COMPETITOR OF ELAN" shall mean any entity
listed on Schedule 3 hereto, subject to Clause 1.52.3 and
amendment from time to time upon mutual written agreement of
Newco, Athersys and Elan.
1.52.3 The Technological Competitor of Elan and Technological
Competitor of Athersys shall include any and all divisions or
subsidiaries and successors of such entities subject to the
following: except for [***](9) (in whatever name or corporate
or non-corporate form in which [***](10) may exist), which in
any and all events shall remain a Technological Competitor of
Elan, (a) if a Technological Competitor of Elan or Athersys,
as the case may be, shall enter into any transaction of
merger, reorganization or consolidation, or transfer, sale,
assignment or other disposition or acquisition of the capital
stock or substantially all of the assets, of another
Technological Competitor of Elan or Athersys as the case may
be, then the successor entity shall also be considered a
Technological Competitor of Elan or Athersys as the case may
be, and (b) if a Technological Competitor of Elan or Athersys
as the case may be, shall enter into a transaction of merger,
reorganization or consolidation, or transfer, sale, assignment
or other disposition or acquisition of the capital stock or
substantially all of the assets, of an entity other than a
Technological Competitor of Elan or Athersys as the case may
be, then the successor entity shall also be considered a
Technological Competitor of Elan or Athersys, as the case may
be, only if such Technological Competitor of Elan or Athersys
is the surviving entity. Notwithstanding anything to the
contrary herein, the parties agree that [***](11) and any of
its subsidiaries or affiliates (other than
[***](12) (in whatever name or corporate or non-corporate form in which
[***](13) may exist)), is not a Technological Competitor of Elan.
1.53. "TERM" shall have the meaning set forth in Clause 9.
(9) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(10) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(11) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(12) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(13) CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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1.54. "TERRITORY" shall mean all the countries of the world.
1.55. "UNITED STATES DOLLAR" and "US$" shall mean the lawful currency for the
time being of the United States of America.
1.56. In this Agreement:
1.56.1 The singular includes the plural and vice versa, and the
masculine includes the feminine and vice versa and the neuter
includes the masculine and the feminine.
1.56.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to the Clause or Schedule of this
Agreement.
1.56.3 The headings of this Agreement are for ease of reference only
and shall not affect its construction or interpretation.
2. ATHERSYS LICENSE TO NEWCO
2.1. Athersys hereby grants to Newco for the Term an exclusive world-wide
license (including the limited right to grant sublicenses under Clause
2.5) (the "ATHERSYS LICENSE") of the Athersys Intellectual Property
solely to research, develop and otherwise engage in the
Commercialization of the Product solely for use in the Field.
2.2. If Athersys would owe a third party royalty or other compensation
obligations based on the practice of the Athersys Intellectual Property
by Newco in connection with the Project, Athersys will inform Newco and
Elan of such royalty or compensation obligation. If Newco and Elan
agree to utilize such Athersys Intellectual Property in connection with
the Project, Newco will be responsible for the payment of such royalty
or other compensation obligations incurred based on such use.
For the avoidance of doubt, royalties, milestones or other payment
obligations of Athersys that arise from the practice of the Athersys
Intellectual Property by Newco in connection with the Project (for
example, a milestone payment payable upon successful completion of
Phase II clinical trials, the filing of an NDA application, obtaining
NDA approval, or first commercial sale) shall be payments for which
Newco will be responsible under this Clause 2.2, provided that such
payment obligations were disclosed to Newco by Athersys as required
above.
2.3. Elan shall be a third party beneficiary under this Agreement and shall
have the right to cause Newco to enforce Newco's rights under this
Agreement against Athersys.
2.4. Notwithstanding anything contained in this Agreement to the contrary,
Athersys shall retain all rights to fully exploit and grant licenses
and sublicenses with respect to the Athersys Intellectual Property
except as such rights are exclusively licensed to Newco under the
Athersys License. Newco hereby covenants that it shall not practice,
use or sublicense the Athersys Intellectual Property except as
expressly permitted under the Athersys License.
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2.5. Newco shall not assign any of its rights under the Athersys License
relating to the Athersys Intellectual Property, or any of its rights
under the Newco Intellectual Property relating to the Product for use
in the Field, without the prior written consent of Elan and Athersys.
Newco shall not sublicense any of its rights under the Athersys License
relating to the Athersys Intellectual Property, or license any of its
rights under the Newco Intellectual Property relating to the Product
for use in the Field, without the prior written consent of Elan and
Athersys, which consent shall not be unreasonably withheld or delayed;
provided, however, that the consent of Elan or Athersys may be withheld
in Elan's or Athersys's sole discretion in the case of a proposed
sublicense of such rights to a Technological Competitor of Elan or a
Technological Competitor of Athersys, as the case may be.
2.6. Newco shall not enter into any agreement with any third party for
development of the Athersys Intellectual Property without the prior
written consent of Athersys, which consent may be withheld in
Athersys's sole discretion. Any agreement between Newco and any
permitted third party for the development or exploitation of the
Athersys Intellectual Property shall be limited expressly to
development or exploitation relating solely to the research,
development and/or Commercialization of the Product in the Field and
shall require such third party to maintain the confidentiality of all
information concerning the Athersys Intellectual Property, and shall
expressly provide that any Athersys Improvements shall belong to
Athersys.
2.7. Insofar as the obligations owed by Newco to Athersys are concerned,
Newco shall remain responsible for all acts and omissions of any
permitted sub-licensee, that violate the terms of this Agreement,
including Elan, as if they were acts and omissions by Newco.
3. SUBSTITUTE INDICATIONS/PRODUCTS
3.1. The Parties acknowledge that the provisions relating to the selection
and designation of a Substitute Protein/Indication are set forth in
Clauses 7.2 and 7.3 of the JDOA.
4. INTELLECTUAL PROPERTY
4.1. OWNERSHIP OF INTELLECTUAL PROPERTY:
4.1.1 All rights, title, and interest to any Athersys Improvements
shall be the property of Athersys; and Newco and Elan shall
execute and deliver documents, and take such other actions as
Athersys may reasonably request, to effect or evidence such
ownership.
4.1.2 The Parties agree that Newco shall own all rights, title, and
interest in and to the Newco Intellectual Property.
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4.1.3 Athersys shall own and retain all rights, title, and interests
in and to the Athersys Intellectual Property, subject only to
the license rights granted to Newco under Clause 2.
4.2. TRADEMARKS.
4.2.1 Athersys hereby grants to Newco for the Term a non-exclusive,
royalty free license in the Territory to use and display the
Athersys Trademarks to promote and sell the Product in the
Field in the Territory. The following provisions shall apply
as regards the use of the Athersys Trademarks by Newco
hereunder:
(1) Newco shall ensure that each reference to and use of
an Athersys Trademark by Newco is in a manner
approved by Athersys (such approval not to be
unreasonably withheld) and accompanied by an
acknowledgement, in a form approved by Athersys, that
the same is a trademark (or registered trademark) of
Athersys.
From time to time, upon the reasonable request of
Athersys, Newco shall submit samples of the Product
to Athersys or its duly appointed agent to ensure
compliance with quality standards and specifications
reasonably determined by Athersys relating to RAGE or
the Selected Protein. Athersys, or its duly appointed
agent, shall have the right to inspect the premises
of Newco where the Product is manufactured, held or
stored, and Newco shall permit such inspection, upon
reasonable advance notice and at a time reasonably
convenient to Newco, of the methods and procedures
used in the manufacture, storage and sale of the
Product, which inspection shall be subject to
appropriate and reasonable restrictions and
limitations regarding safety and confidentiality.
Newco shall not sell or otherwise dispose of any
Product bearing the Athersys Trademarks that fails to
comply with the quality standards and specifications
referred to in this Clause 4.2.
(2) Newco shall not use an Athersys Trademark in any way
that might materially prejudice its distinctiveness
or validity or the goodwill of Athersys therein.
(3) The Parties recognize that the Athersys Trademarks
have considerable goodwill associated therewith.
Newco shall not use in relation to the Product any
trademarks other than the Athersys Trademarks (except
the Elan Trademarks licensed to Newco under the Elan
License Agreement) without obtaining the prior
consent in writing of Athersys, which consent may not
be unreasonably withheld. However, such use must not
conflict with the use and display of the Athersys
Trademark and such use and display must be approved
by Athersys.
(4) Newco shall not use in the Territory any trademarks
or trade names so resembling the Athersys Trademark
as to be likely to cause confusion or deception.
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(5) Newco shall promptly notify Athersys in writing of
any alleged infringement or unauthorized use of which
it becomes aware by a third party of the Athersys
Trademarks and provide Athersys with any applicable
evidence of infringement or unauthorized use.
(6) Newco shall favorably consider promoting and using
the Athersys Trademarks in each country of the
Territory and provide proof of such use upon request
by Athersys.
(7) Newco shall not be permitted to assign or sublicense
any of its rights under the Athersys Trademarks
without the prior written consents of Athersys, which
consent shall not be unreasonably withheld or
delayed.
4.2.2 Athersys shall, at its sole expense and discretion, file and
prosecute applications to register and maintain registrations
of the Athersys Trademarks in the Territory. Newco shall
reasonably co-operate with Athersys in such efforts. If
Athersys decides to withdraw a mark from further prosecution
or fails to maintain such mark, Newco may request Athersys to
continue such prosecution or maintenance at Newco's expense.
Athersys may comply with Newco's request unless Athersys
believes such action is without merit.
4.2.3 Athersys will be entitled to conduct all enforcement
proceedings relating to the Athersys Trademarks and shall at
its sole discretion decide what action, if any, to take in
respect to any enforcement proceedings of the Athersys
Trademarks or any other claim or counter-claim brought in
respect to the use or registration of the Athersys Trademarks.
Any such proceedings shall be conducted at Athersys's expense
and for its own benefit. Newco shall reasonably cooperate with
Athersys in such efforts. If Athersys decides to withdraw a
mark from further prosecution or fails to maintain such mark,
Newco may request Athersys to continue such prosecution or
maintenance at Newco's expense. Athersys may comply with
Newco's request unless Athersys believes such action is
without merit.
4.2.4 Newco shall promptly notify Athersys in writing in the event
that any Athersys Trademark has been challenged by a third
party in a judicial or administrative proceeding in a country
in the Territory as infringing on the rights of a third party
and Athersys shall have the first right to decide whether or
not to defend such allegations, or to adopt an alternative
mark. If Athersys decides not defend the Athersys Trademark,
then Newco may request Athersys to defend the Athersys
Trademark, at Newco's expense, unless such requested defense
is believed by Athersys to be unsubstantiated and without
merit. In such a case, Athersys may elect not initiate defense
proceedings.
4.2.5 Newco will have no ownership rights in respect of the Athersys
Trademarks or of the goodwill associated therewith, and Newco
hereby acknowledges that, except as expressly provided in this
Agreement, it shall not acquire any rights in respect thereof
and that all such rights and goodwill are, and will remain,
vested in Athersys.
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4.2.6 Nothing in this Agreement shall be construed as a warranty on
the part of Athersys regarding the Athersys Trademarks,
including without limitation, that use of the Athersys
Trademarks in the Territory will not infringe the rights of
any third parties. Accordingly, Newco acknowledges and agrees
that Athersys makes no such warranty.
4.2.7 Athersys assumes no liability to Newco or to any third parties
with respect to the quality, performance or characteristics of
any of the goods manufactured or sold by Newco under the
Athersys Trademarks pursuant to this Agreement.
5. AFTER ACQUIRED TECHNOLOGY
5.1. If after the Effective Date Athersys acquires Know-How or Patent Rights
from a third Party relating to the Athersys Intellectual Property, or
if Athersys acquires or merges with a third party entity that owns or
has license rights to Know-How or Patent Rights relating to the
Athersys Intellectual Property, then Athersys shall offer to license
such Know-How and Patent Rights to Newco (subject to existing
contractual obligations) solely for Newco to research, develop and
otherwise engage in the Commercialization of the Product solely for use
in the Field (for purposes of this Clause 5.1, the "Field of Use"), on
such terms as would be offered to an independent third party
negotiating in good faith on an arms-length basis.
If the Elan representatives on the Management Committee determine that
Newco should not acquire such license, or if the parties are unable to
reach agreement on such commercial terms within 120 days from
Athersys's offer to Newco or within another mutually agreeable period,
then Athersys shall be free to fully exploit such Know-How and Patent
Rights in such Field of Use, and to grant to third parties licenses and
sublicenses with respect thereto. Notwithstanding the foregoing,
Athersys shall retain all rights to exploit and license any such
acquired Know-How and Patent Rights for all purposes outside of such
Field of Use.
6. FINANCIAL PROVISIONS
6.1. ROYALTIES:
The intent of the Parties and Elan is to provide for equivalent
economic benefit to each of Athersys and Elan. Accordingly, prior to
the Commercialization of the Product, the Management Committee shall
consider and if appropriate, determine reasonable royalties with
respect to the Commercialization of the Product by Newco that shall be
payable by Newco to Elan and Athersys, and shared by Elan and Athersys
pro rata with Elan's and Athersys's respective percentage ownership of
stock (whether common stock and/or preferred stock) in Newco.
6.2. Payment of royalties pursuant to Clause 6.1 shall be made quarterly in
arrears during each Financial Year within 60 days after the expiry of
the applicable calendar quarter. The method of payment shall be by wire
transfer to an account specified by Athersys. Each payment made to
Athersys shall be accompanied by a true accounting of all
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Product sold by Newco, its Affiliates and permitted sublicensees, if
any, during such quarter.
Such accounting shall show, on a country-by-country and
Product-by-Product basis, Net Sales (and the calculation thereof) and
each calculation of royalties with respect thereto, including the
calculation of all adjustments and currency conversions.
6.3. Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of 3 years:
6.3.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
6.3.2 to enable any deductions made in the Net Sales calculation to
be determined.
6.4. All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product for each calendar quarter made
in a currency other than United States Dollars shall first be
calculated in the foreign currency and then converted to United States
Dollars on the basis of the exchange rate in effect on the last working
day for such quarter for the purchase of United States Dollars with
such foreign currency quoted in the Wall Street Journal (or comparable
publication if not quoted in the Wall Street Journal) with respect to
the currency of the country of origin of such payment.
6.5. If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of paying
Athersys the amount of such royalties. In the event that Newco is
prevented from making any payment under this Agreement by virtue of the
statutes, laws, codes or government regulations of the country from
which the payment is to be made, then such payments may be paid by
depositing them in the currency in which they accrue to Athersys's
account in a bank acceptable to Athersys in the country the currency of
which is involved or as otherwise agreed by the Parties.
6.6. Athersys and Newco agree to co-operate in all respects necessary to
take advantage of any double taxation agreements or similar agreements
as may, from time to time, be available.
6.7. Any taxes payable by Athersys on any payment made to Athersys pursuant
to this Agreement shall be for the account of Athersys. If so required
by applicable law, any payment made pursuant to this Agreement shall be
made by Newco after deduction of the appropriate withholding tax, in
which event the Parties shall co-operate to obtain the appropriate tax
clearance as soon as is practicable. On receipt of such clearance,
Newco shall forthwith arrange payment to Athersys of the amount so
withheld.
7. RIGHT OF INSPECTION AND AUDIT
7.1. No more than once every twelve months and upon reasonable advance
notice requested by Athersys, Newco shall permit Athersys or its duly
authorized
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representatives, at any reasonable time during normal business hours,
to have access to inspect and audit the accounts and records of Newco
and any other book, record, voucher, receipt or invoice relating to the
calculation of the royalty payments on Net Sales submitted to Athersys.
Such inspection shall be of records relating to a time period not
previously audited hereunder, and in no event older than three years.
Any such inspection of Newco's records shall be at the expense of
Athersys, except that if any such inspection reveals a deficiency in
the amount of the royalty actually paid to Athersys hereunder during
the period inspected of 5% or more of the amount of any royalty
actually due to Athersys hereunder for such period, then the expense of
such inspection shall be borne solely by Newco. Any amount of
deficiency shall be paid promptly to Athersys by Newco.
If such inspection reveals a surplus in the amount of royalties
actually paid to Athersys by Newco, Athersys shall reimburse Newco the
surplus within 15 days after determination.
7.2. In the event of any unresolved dispute regarding any alleged deficiency
or overpayment of royalty payments hereunder, the matter will be
referred to an independent firm of chartered accountants chosen by
agreement of Athersys and Elan for a resolution of such dispute. Any
decision by the said firm of chartered accountants shall be binding on
the Parties.
8. REPRESENTATIONS AND WARRANTIES
8.1. Athersys represents and warrants to Newco that, as of the Effective
Date, to Athersys' best knowledge:
(a) Athersys has the right to grant the Athersys License;
(b) Schedule 1 contains the primary examples of Athersys Patent
Rights existing as of the date hereof, which listing is not
necessarily exhaustive;
(c) there are no agreements between Athersys and any third parties
that would conflict with or would prevent Athersys from
granting the Athersys License to Newco;
(d) Athersys is the owner or licensee of all rights, title and
interest in the Athersys Intellectual Property,
(e) Athersys has no knowledge of any pending or threatened action,
suit, proceeding or claim by others challenging Athersys'
rights in or to such Athersys Intellectual Property as related
to the Field, which would have a material adverse effect on
the ability of Newco to conduct the Project; and
(f) the Athersys Intellectual Property constitutes all
intellectual property owned or licensed by Athersys that are
reasonably applicable to the Project as it relates to the
Selected Protein produced using RAGE.
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8.2. Athersys further represents and warrants to Newco as follows:
(a) there are no existing or claimed defaults by Athersys, and to
Athersys' best knowledge by any other party, under any license
agreement pursuant to which Athersys has obtained any license
rights to any Athersys Intellectual Property; and no event,
act or omission has occurred which (with or without notice,
lapse of time or the happening or occurrence of any other
event) would result in a default under such license agreements
by Athersys, or to Athersys's best knowledge by any other
party, and
(b) Athersys shall, during the term of the Licenses, comply with
the material terms and conditions of such license agreements
and will if appropriate enforce its rights under such license
agreements.
8.3. In addition to any other indemnities provided for herein, Athersys
shall indemnify and hold harmless Newco and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Newco arising
out of or in connection with any:
8.3.1 breach of any representation, covenant, warranty or obligation
by Athersys hereunder; or
8.3.2 act or omission on the part of Athersys or any of its
respective employees, agents, officers and directors in the
performance of this Agreement.
8.4. In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Athersys and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Athersys arising
out of or in connection with any:
8.4.1 breach of any representation, covenant, warranty or obligation
by Newco hereunder; or
8.4.2 act or omission on the part of Newco or any of its agents or
employees in the performance of this Agreement.
8.5. The Party seeking an indemnity shall:
8.5.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
8.5.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
8.5.3 co-operate in the investigation and defense of such claim or
proceeding;
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8.5.4 not compromise or otherwise settle any such claim or
proceeding without the prior written consent of the other
Party, which consent shall not be unreasonably withheld
conditioned or delayed; and
8.5.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
8.6. EXCEPT AS SET FORTH IN THIS CLAUSE 8, ATHERSYS IS GRANTING THE ATHERSYS
LICENSE HEREUNDER ON AN "AS IS" BASIS WITHOUT REPRESENTATION OR
WARRANTY WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF
THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.
8.7. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER
ATHERSYS NOR NEWCO SHALL BE LIABLE TO THE OTHER BY REASON OF ANY
REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OF THIS AGREEMENT
OR THE JDOA OR ANY DUTY OF COMMON LAW, FOR ANY INDIRECT, CONSEQUENTIAL,
SPECIAL, INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF
PROFITS OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE
BREACHING PARTY, ITS EMPLOYEES OR AGENTS OR OTHERWISE.
9. TERM AND TERMINATION
9.1. TERM
9.1.1 The term of this Agreement ("the Term") shall commence as of
the Effective Date and shall, subject to Clause 9.1.2 and
early termination of the Agreement pursuant to the other
provisions of this Clause 9, expire on a country-by-country
basis on the last to occur of:
(a) 15 years starting from the date of the first
commercial sale of the Product in the country
concerned; or
(b) the date of expiration of the last to expire of the
Patents Rights included in the Athersys Patent Rights
and/or Athersys Improvements.
9.1.2 In no event shall the Term exceed twenty-five (25) years from the
Effective Date.
9.2. TERMINATION
If either Party commits a Relevant Event, the other Party shall have,
in addition to all other legal and equitable rights and remedies
hereunder, the right to terminate this Agreement upon 30 days' prior
written notice to the defaulting Party, such notice to be provided if
at all within 180 days after the occurrence of such Relevant Event.
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9.3. For the purpose of this Clause 9, a "RELEVANT EVENT" is committed or
suffered by a Party if:
9.3.1 such Party commits a material breach of its obligations under
this Agreement and fails to cure or remedy such breach within
60 days of being specifically required in writing to do so by
the other Party; provided, that if the breaching Party has
proposed a course of action to rectify or cure the breach and
is acting in good faith to rectify or cure same but has not
cured the breach by the 60th day, such period shall be
extended by such period as is reasonably necessary to permit
the breach to be rectified so long as such breaching Party
continues to exert good faith efforts to rectify or cure the
breach; or
9.3.2 such Party ceases wholly or substantially to carry on its
business, otherwise than for the purpose of a reconstruction
or amalgamation, without the prior written consent of the
other Party (such consent not to be unreasonably withheld);
9.3.3 upon the appointment, as to such Party, of a liquidator,
receiver, administrator, examiner, trustee or similar officer
with authority over all or substantially all of its assets
under the law of any applicable jurisdiction, including
without limitation, the United Sates of America, Bermuda or
Ireland; or
9.3.4 an application or petition for bankruptcy, corporate
re-organization, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the law of any applicable jurisdiction,
including without limitation, the United States of America,
Bermuda or Ireland, is filed by a Party, and is not discharged
within 60 days, or all or substantially all of the assets,
rights, revenues and/or business of a Party are for any reason
seized, confiscated or condemned.
9.4. If Elan terminates the Elan License Agreement in accordance with Clause
9.4 thereof due to a Change of Control of Athersys/Newco, then Athersys
shall have the right, at its election, to terminate this Agreement upon
ten business days prior written notice to Elan.
9.5. Upon expiration or termination of this Agreement:
(a) any sums that were due from Newco to Athersys on Net Sales in
the Territory or in such particular country or countries in
the Territory (as the case may be) prior to the expiration or
termination of this Agreement as set forth herein shall be
paid in full within 60 days after the expiration or
termination of this Agreement for the Territory or for such
particular country or countries in the Territory (as the case
may be);
(b) any provisions that expressly survive termination or
expiration of this Agreement, including without limitation
this Clause 9, shall remain in full force and effect;
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(c) all representations, warranties and indemnities shall insofar
as are appropriate remain in full force and effect;
(d) the rights of inspection and audit set out in Clause 7 shall
continue in force for a period of one year;
(e) all rights and licenses granted to Newco pursuant to this
Agreement and to the Athersys Intellectual Property pursuant
to the JDOA (including the rights of Newco pursuant to Clause
11 of the JDOA with respect to patent prosecution and
maintenance) shall cease for the Territory or for such
particular country or countries in the Territory (as the case
may be) and shall revert to or be transferred to Athersys, and
Newco shall not thereafter use in the Territory or in such
particular country or countries in the Territory (as the case
may be) any such rights covered by this Agreement;
(f) Subject to Clause 9.5.(g) and to such license, if any, granted
by Newco to Athersys pursuant to the provisions of Clause 12
of the JDOA (entitled "Exploitation Outside the Field"), all
rights to Newco Intellectual Property shall be automatically
licensed, on a world-wide, non-exclusive, perpetual
royalty-free basis, to each of Athersys and Elan, and each of
Elan and Athersys may independently and separately exploit
such Newco Intellectual Property pursuant to such
non-exclusive license (with the right to sublicense) without
accounting to the other;
(g) the rights of permitted third party sub-licensees in and to
the Athersys Intellectual Property shall survive the
termination of the license and sublicense agreements granting
said intellectual property rights to Newco; and Newco, Elan
and Athersys shall in good faith agree upon the form most
advantageous to Elan and Athersys in which the rights of Newco
under any such licenses and sublicenses are to be held (which
form may include continuation of Newco solely as the holder of
such licenses or assignment of such rights to a third party or
parties, including an assignment to both Elan and Athersys).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco to
Elan and Athersys and shall contain appropriate
confidentiality provisions.
10. CONFIDENTIAL INFORMATION
10.1. The Parties agree that it will be necessary, from time to time, to
disclose to each other confidential and proprietary information,
including without limitation, inventions, works of authorship, trade
secrets, specifications, designs, data, know-how and other proprietary
information relating to the Field, the Product, processes, services and
business of the disclosing Party.
The foregoing shall be referred to collectively as "CONFIDENTIAL
INFORMATION".
10.2. Any Confidential Information disclosed by one Party to another Party
shall be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Party's obligations under this Agreement and
the JDOA and for no other purpose.
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10.3. Each Party shall disclose Confidential Information of the
other Party only to those employees, representatives and
agents requiring knowledge thereof in connection with
fulfilling the Party's obligations under this Agreement. Each
Party further agrees to inform all such employees,
representatives and agents of the terms and provisions of this
Agreement and their duties hereunder and to obtain their
agreement hereto as a condition of receiving Confidential
Information. Each Party shall exercise the same standard of
care as it would itself exercise in relation to its own
confidential information (but in no event less than a
reasonable standard of care) to protect and preserve the
proprietary and confidential nature of the Confidential
Information disclosed to it by the other Party. Each Party
shall, upon request of the other Party, return all documents
and any copies thereof containing Confidential Information
belonging to, or disclosed by, such other Party.
10.4. Any breach of this Clause 10 by any person informed by one of the
Parties is considered a breach by the Party itself.
10.5. The obligations of a Party under this Clause 10 with respect to the
Confidential Information of the other Party shall not apply to:
10.5.1 information that is in the public domain;
10.5.2 information that is made public through no breach of this
Agreement;
10.5.3 information that is independently developed by a Party without
reliance on any of the other Party's Confidential Information,
as evidenced by such Party's records;
10.5.4 information that becomes available to a Party on a
non-confidential basis, whether directly or indirectly, from a
source other than a Party, which source did not acquire this
information on a confidential basis; or
10.6. Further, a receiving Party may disclose the Confidential Information of
the other Party to the extent it is required to disclose such
information pursuant to:
(i) a valid order of a court or other governmental body;
or
(ii) any other requirement of law;
provided that if the receiving Party becomes legally required
to disclose any Confidential Information, the receiving Party
shall give the disclosing Party prompt notice of such fact so
that the disclosing Party may obtain a protective order or
other appropriate remedy concerning any such disclosure. The
receiving Party shall fully co-operate with the disclosing
Party in connection with the disclosing Party's efforts to
obtain any such order or other remedy. If any such order or
other remedy does not fully preclude disclosure, the receiving
Party shall make such disclosure only to the extent that such
disclosure is legally required.
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10.7. The provisions relating to confidentiality in this Clause 10 shall
remain in effect during the term of this Agreement, and for a period of
7 years following the expiration or earlier termination of this
Agreement.
10.8. The Parties agree that the obligations of this Clause 10 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party agrees that monetary damages would be inadequate to
compensate a Party for any breach by the other Party of its covenants
and agreements set forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable injury to a Party and that, in
addition to any other remedies that may be available, in law and equity
or otherwise, each Party may be entitled to obtain injunctive relief
against the threatened breach of the provisions of this Clause 10, or a
continuation of any such breach by the other Party, specific
performance and other equitable relief to redress such breach together
with its damages and reasonable counsel fees and expenses to enforce
its rights hereunder, without the necessity of proving actual or
express damages.
11. GOVERNING LAW AND JURISDICTION
11.1. This Agreement shall be governed by and construed in accordance with
the substantive laws of the State of New York, without giving effect to
the provisions thereof relating to the conflict of laws.
11.2. The Parties will attempt in good faith to resolve any dispute arising
out of or relating to this Agreement promptly by negotiation between
executives of the Parties. In the event that such negotiations do not
result in a mutually acceptable resolution, the Parties agree to
consider other dispute resolution mechanisms including mediation.
In the event that the Parties fail to agree on a mutually acceptable
dispute resolution mechanism, any such dispute shall be settled in
accordance with the terms of Clauses 19 and 24.7 of the JODA.
12. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Athersys nor Newco shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay results
from causes beyond its reasonable control, including, without
limitation, acts of God, fires, strikes, acts of war, intervention of a
government authority, provided that the Party whose performance is
delayed or prevented continues to use good faith diligent efforts to
mitigate, avoid or end such delay or failure in performance as soon as
practicable.
13. ASSIGNMENT
Each Party shall not be permitted to assign its rights or obligations
hereunder without the prior written consent of the other Party except
as follows:
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13.1. The Parties shall have the right to assign their rights and obligations
hereunder to their respective Affiliates, provided, however, that such
assignment does not result in adverse tax consequences for the other
Party.
13.2. Athersys shall be entitled to assign this Agreement to its successor in
interest pursuant to acquisition, merger, consolidation or purchase of
all or substantially all of the assets of Athersys. For the avoidance
of doubt, nothing in this Clause 13 shall prejudice Elan's rights under
the Elan License Agreement, including Elan's right to terminate the
Elan License Agreement in accordance with Clause 9.4 thereof.
14. NOTICES
14.1. Any notice to be given under this Agreement shall be sent by registered
airmail or telefaxed to the following addresses:
If to Newco at:
Clarendon House
Church St.
Hamilton, Bermuda
Attention: Secretary
Telephone: 441 292 9169
Fax: 441 292 2224
with a copy to Elan at:
Elan Corporation, plc
C/o Elan International Services. Ltd.
102 St. James Court
Flatts
Smiths FL04 Bermuda
Attention: Secretary
Telephone: 441 292 9169
Telefax: 441 292 2224
If to Athersys at:
11000 Cedar Avenue
Cleveland, Ohio 44106
USA
Attention: President and Chief Executive Officer
Telephone: (216) 231-9911
Fax: (216) 231-0905
with a copy to:
Cooley Godward LLP
Five Palo Alto Square
3000 El Camino Real
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Palo Alto, CA 94306
Attention: Barclay James Kamb, Esq.
Telephone (650) 843-5052
Fax: (650) 857-0663
If to Elan at:
Elan Corporation, plc
C/o Elan International Services. Ltd.
102 St. James Court
Flatts
Smiths FL04 Bermuda
Attention: Secretary
Telephone: 441 292 9169
Telefax: 441 292 2224
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder.
14.2. Any notice sent by mail shall be deemed to have been delivered within
seven 7 working days after dispatch and any notice sent by telex or
telefax shall be deemed to have been delivered within twenty 24 hours
of the time of the dispatch. Notice of change of address shall be
effective upon receipt.
15. MISCELLANEOUS
15.1. WAIVER:
No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of
any other right arising under this Agreement.
15.2. SEVERABILITY:
If any provision in this Agreement is agreed by the Parties to be, or
is deemed to be, or becomes invalid, illegal, void or unenforceable
under any law that is applicable hereto:
(a) The Parties shall attempt in good faith to amend the Agreement
to provide an alternate to such provision to conform to
applicable laws so as to be valid and enforceable; and retain
the intent of the Parties relating to such provision; or
(b) If the Parties cannot so amend the Agreement without
materially altering the intention of the Parties, it will be
deleted, with effect from the date of such agreement or such
earlier date as the Parties may agree, and the validity,
legality and enforceability of the remaining provisions of
this Agreement shall not be impaired or affected in any way.
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15.3. FURTHER ASSURANCES:
At the request of any of the Parties, the other Party or Parties shall
(and shall use reasonable efforts to procure that any other necessary
parties shall) execute and perform all such documents, acts and things
as may reasonably be required subsequent to the signing of this
Agreement for assuring to or vesting in the requesting Party the full
benefit of the terms hereof.
15.4. SUCCESSORS:
This Agreement shall be binding upon and inure to the benefit of the
Parties hereto, their successors and permitted assigns.
15.5. NO EFFECT ON OTHER AGREEMENTS/CONFLICT:
No provision of this Agreement shall be construed so as to negate,
modify or affect in any way the provisions of any other agreement
between the Parties unless specifically referred to, and solely to the
extent provided herein.
In the event of a conflict between the provisions of this Agreement and
the provisions of the JDOA, the terms of the JDOA shall prevail unless
this Agreement specifically provides otherwise.
15.6. AMENDMENTS:
No amendment, modification or addition hereto shall be effective or
binding on any Party unless set forth in writing and executed by a duly
authorized representative of each Party and Elan.
15.7. COUNTERPARTS:
This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
15.8. NO RELIANCE:
Each Party hereby acknowledges that in entering into this Agreement it
has not relied on any representation or warranty save as expressly set
out herein or in any document referred to herein.
15.9. RELATIONSHIP OF THE PARTIES:
Nothing contained in this Agreement is intended or is to be construed
to constitute Athersys and Newco as partners, or Athersys as an
employee of Newco, or Newco as an employee of Athersys.
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Neither Party hereto shall have any express or implied right or
authority to assume or create any obligations on behalf of or in the
name of the other Party or to bind the other Party to any contract,
agreement or undertaking with any third party.
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IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED
BY: /s/ Gil Van Bokkelen
---------------------------------------
for and on behalf of
ATHERSYS, INC.
SIGNED
BY: /s/ I. S. Outerbridge
---------------------------------------
For and on behalf of
ATHERSYS NEWCO LTD.
CONSENTED AND AGREED TO:
SIGNED
BY: /s/ Kevin Insley
---------------------------------------
For and on behalf of
ELAN CORPORATION, PLC, ACTING THROUGH
ITS DIVISION ELAN PHARMACEUTICAL
TECHNOLOGIES
SIGNED
BY: /s/ Kevin Insley
---------------------------------------
for and on behalf of
ELAN PHARMA INTERNATIONAL LIMITED
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