Exhibit 10.16
 
 
 
LICENSE AGREEMENT
 
by and between
 
RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER
 
and
 
ACORDA THERAPEUTICS, INC.
 

 
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THIS LICENSE AGREEMENT effective as of September 26, 2003 (“Effective Date”), by
and between RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER, an Illinois
not-for-profit corporation and having its principal office at 1725 W. Harrison
St. Chicago, Ill. 60612 (“RUSH”) and ACORDA THERAPEUTICS, INC., a corporation
organized and existing under the laws of the State of Delaware and having its
principal office at 15 Skyline Drive, Hawthorne, New York 10532 (“ACORDA”).
 
W I T N E S S E T H:
 
WHEREAS, RUSH has conducted investigations of the compound known as
4-aminopyridine for treatment of the symptoms of multiple sclerosis and has
accordingly developed know-how in relation thereto;
 
WHEREAS, RUSH has received a notice of designation (the “Rush Orphan
Designation”) from the FDA stating that the Licensed Product (as defined herein)
“qualifies for orphan designation for the relief of symptoms of multiple
sclerosis;”
 
WHEREAS, RUSH’s right and title to the Rush Orphan Designation for the Licensed
Product has been assigned to ACORDA and RUSH has consented to such assignment;
 
WHEREAS, RUSH has the right to grant licenses in respect of the RUSH Know-How
(as defined herein) and has granted no licenses thereto except (i) the option
agreement, dated September 7, 1990 (the “Option Agreement”), between RUSH and
Elan Pharmaceutical Research Corp. (“EPRC”), a predecessor corporation of Elan
Drug Delivery Inc., a wholly-owned subsidiary of Elan Corporation plc (“ELAN”)
and (ii) the license agreement dated November 13, 1990 (the “Rush/Elan
License”), between RUSH and EPRC, (the Option Agreement and the Rush/Elan
License being collectively referred to herein as the “Rush/Elan Agreements”);
 
WHEREAS, pursuant to the Side Agreement, as defined below, RUSH and ELAN and
EPRC have, among other things terminated the Rush/Elan Agreements as of the
Effective Date;
 
WHEREAS, ACORDA desires to obtain exclusive license rights, with a right to
grant sublicenses, under and to the RUSH Know-How (as defined herein), and RUSH
desires to grant such license to ACORDA, upon the terms and conditions set forth
herein; and
 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and intending to be
legally bound, the Parties hereby agree as follows:
 
 
ARTICLE I
DEFINITIONS
 

 
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Unless specifically set forth to the contrary herein, the following terms, where
used in the singular or plural, shall have the respective meanings set forth
below:
 
 

 
1.1.                              “Act” shall mean the Federal Food Drug and
Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or
any successor act, as the same shall be in effect from time to time.

 
 

 
1.2.                              “Affiliate” shall mean (i) any corporation or
business entity of which more than fifty percent (50%) of the securities or
other ownership interests representing the equity, the voting stock or general
partnership interest are owned, controlled or held, directly or indirectly, by a
Party; (ii) any corporation or business entity which, directly or indirectly,
owns, controls or holds more than fifty percent (50%) (or the maximum ownership
interest permitted by law) of the securities or other ownership interests
representing the equity, voting stock or general partnership interest of a Party
or (iii) any corporation or business entity of which a Party has the right to
acquire, directly or indirectly, at least fifty percent (50%) of the securities
or other ownership interests representing the equity, voting stock or general
partnership interest thereof.

 
 

 
1.3.                              “Base Royalty Term” shall mean, in any country
in the Territory, the period beginning with the date of the First Commercial
Sale in such country and continuing until the earlier of (i) expiration of the
last to expire Elan Patent in such country; or (ii) ten (10) years from the date
of First Commercial Sale in such country; provided however, that, in the event
that ACORDA receives Regulatory Approval in the United States for Licensed
Product with an Orphan Designation for the treatment of multiple sclerosis, then
the Base Royalty Term in the United States shall not be less than seven years
from the date of First Commercial Sale in the United States.  In the event that
RUSH’s further development of the RUSH Know-How results in the issuance to RUSH
of a patent in any country or additional Orphan Drug Designation following the
effective date of this Agreement that provides for a greater period of market
exclusivity of the Product in such country, the Base Royalty Term in such
country will continue for that period of market exclusivity provided by such
patent or Orphan Drug Designation.

 
 

 
1.4.                              “Business Day(s)” shall mean any day that is
not a Saturday or a Sunday or a day on which the New York Stock Exchange is
closed.

 
 

 
1.5.                              “Calendar Quarter” shall mean the respective
periods of three (3) consecutive calendar months ending on March 31, June 30,
September 30 and December 31.

 
 

 
1.6.                              “Calendar Year” shall mean each successive
period of twelve (12) months commencing on January 1 and ending on December 31.

 
 

 
1.7.                              “Compound” shall mean the chemical compound
known as  4-aminopyridine, as diagrammed on Schedule 1.7 hereto.

 
 

 
1.8.                              “CFR” shall mean the United States Code of
Federal Regulations.

 
 

 
1.9.                              “Effective Date” shall mean the date first
above written.

 

 
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1.10.                        “Elan/Acorda License” shall mean the Amended and
Restated License Agreement effective as the Effective Date        by and between
ACORDA and ELAN.

 
 

 
1.11.                        “Elan Patent” shall mean any patent included in the
Elan Patent Rights as set forth on Schedule 1.11 hereto

 
 

 
1.12.                        “End of Phase 2 Meeting” shall mean the first end
of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended
to determine the safety of proceeding to a  Phase 3 Clinical Trial, evaluate the
Phase 3 plan and protocols and identify any additional information necessary to
support the NDA.

 
 

 
1.13.                        “FDA” shall mean the United States Food and Drug
Administration and any successor agency having substantially the same functions.

 
 

 
1.14.                        “First Commercial Sale” shall mean the first
commercial sale of Product by ACORDA, its Affiliate or its sublicensees in a
country, for end use or consumption, after all required Regulatory Approvals
have been granted by the governing health authority of such country. Sales for
test marketing, clinical trial purposes, research and development, or
compassionate or similar use where Acorda does not receive revenue from the sale
other than cost recovery, shall not be deemed to constitute a commercial sale.

 
 

 
1.15.                        “GAAP” shall mean generally accepted accounting
principles in the United States, consistently applied.

 
 

 
1.16.                        “Improvement” shall mean any and all improvements
and enhancements, patentable or otherwise, related to the Compound or Product
including, without limitation, in the manufacture, formulation,
ingredients, preparation, presentation, means of delivery or administration,
dosage, indication, use or packaging of Compound or Product.

 
 

 
1.17.                        “Licensed Product” shall mean any Product that
utilizes or exploits the RUSH Know-How in the treatment of multiple sclerosis.

 
 

 
1.18.                        “NDA” shall mean a new drug application as defined
in the Act and applicable regulations promulgated thereunder that is filed with
the FDA to obtain Regulatory Approval of Licensed Product in the United States.

 
 

 
1.19.                        “Neurological Indications” shall mean indications
concerning disorders and conditions of the neuromuscular system, central,
peripheral and autonomic nervous systems, the neuromuscular junction and/or
muscle.  Such indications shall include, but not be limited to, multiple
sclerosis and spinal cord injury.

 
 

 
1.20.                        “Net Sales” shall mean the gross amount invoiced
for commercial sales of Product in the Territory by ACORDA or its Affiliates to
Third Parties commencing upon the date of First Commercial Sale in any country
in the Territory, after deducting the following:

 
 

 
(i)                                     trade, cash and quantity discounts;

 

 
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(ii)                                  credits and allowances on account of
returned or rejected Product, including allowance for breakage or spoilage,
recalls or Product destruction (whether voluntarily made or requested or made by
a Regulatory Authority)

 
 

 
(iii)                               chargebacks, rebates or similar payments
granted to customers, including, but not limited to, managed health care
organizations, wholesalers, distributors, buying groups, retailers, health care
insurance carriers, pharmacy benefit management companies, health maintenance
organizations or other institutions or health care organizations or to federal,
state/provincial, local and other governments, their agencies and purchasers and
reimbursers;

 
 

 
(iv)                              sales or excise taxes, VAT or other taxes, and
transportation, freight, postage, shipping and insurance charges and additional
special transportation, custom duties, and other governmental charges;

 
 

 
(v)                                 retroactive price reductions; and

 
 

 
(vi)                              write-offs or allowances for bad debts, to the
extent permitted by GAAP.

 
Sales or other transfers between ACORDA and its Affiliates shall be excluded
from the computation of Net Sales and no payments will be payable on such sales
or transfers except where such Affiliates are end users, but Net Sales shall
include the subsequent sales to Third Parties by such Affiliates.
 
 
1.21.                        “Orphan Designation” shall mean the designation of
a drug as a drug for a rare disease or condition pursuant to Section 526 of the
Act.

 
 

 
1.22.                        “Party” shall mean RUSH or ACORDA.

 
 

 
1.23.                        “Phase 3 Clinical Trial” shall mean a clinical
trial in patients with multiple sclerosis conducted after an End of Phase 2
Meeting and conducted on a sufficient number of patients that is designed to
establish that Licensed Product is safe and efficacious for its intended use,
and to define warnings, precautions and adverse reactions that are associated
with Licensed Product in the dosage range to be prescribed, and supporting 
Regulatory Approval of Licensed Product in the treatment of multiple sclerosis.

 
 

 
1.24.                        “Product” shall mean any finished pharmaceutical
formulation for prescription use for the treatment of any human Neurological
Indications which contains Compound as the therapeutically active ingredient.

 
 

 
1.25.                        “Proprietary Information” shall mean any and all
scientific, clinical, regulatory, marketing, financial and commercial
information or data, whether communicated in writing, orally or by any other
means, which is owned and under the protection of one

 

 
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Party and is being provided by that Party to the other Party in connection with
this Agreement.
 
 

 
1.26.                        “Reduced Royalty Term” shall mean, in any country
in the Territory, the period of time beginning with the date following the
expiration of the Base Royalty Term in such country and continuing until the
fifteenth anniversary of the Effective Date.

 
 

 
1.27.                        “Regulatory Authority” shall mean the FDA in the
U.S., the EMEA or any agency in the European Union and any health regulatory
authority(ies) in any country(ies) in the Territory that holds responsibility
for granting Regulatory Approval for a Product in such country(ies), and any
successor(s) agency thereto having substantially the same functions.

 
 

 
1.28.                        “Regulatory Approval” shall mean all approvals
(including pricing and reimbursement approvals required for marketing
authorization), product and/or establishment licenses, registrations or
authorizations of all regional, federal, state or local regulatory agencies,
departments, bureaus or other governmental entities, necessary for the
manufacture, use, storage, import, export, transport and sale of Product in a
regulatory jurisdiction.

 
 

 
1.29.                        “Royalty Year” shall mean, (i) for the year in
which the First Commercial Sale occurs (the “First Royalty Year”), the period
commencing with the first day of the Calendar Quarter in which the First
Commercial Sale occurs and expiring on the last day of the Calendar Year in
which the First Commercial Sale occurs; and (ii) for each subsequent year
commencing after the end of the First Royalty Year, each successive Calendar
Year.

 
 

 
1.30.                        “RUSH Know-How” shall mean all information and
materials, including but not limited to, discoveries, information, Improvements,
processes, formulas, data, inventions, know-how and trade secrets, patentable or
otherwise, which as of the Effective Date or at any time during the term of this
Agreement:

 
 

 
(a)                                  relate to Compound or Product; and

 
 

 
(b)                                 were developed by or on behalf of RUSH, are
owned by RUSH or are in RUSH’s possession or control.

 
Such know-how shall include, without limitation, all chemical, pharmaceutical,
toxicological, preclinical, clinical, assay control, regulatory submissions,
designations  and approvals, and any other information used or useful for the
development, manufacturing and/or regulatory approval of Compound or Product,
including such rights which RUSH may have to information developed by Third
Parties.
 
 

 
1.31.                        “Side Agreement” shall mean the Side Agreement by
and among RUSH, ACORDA and ELAN executed as of the Effective Date, a copy of
which is attached hereto as Exhibit 1.31.

 
 

 
1.32.                        “Territory” shall mean all of the countries in the
world.

 
 

 
1.33.                        “Third Party(ies)” shall mean a person or entity
who or which is neither a Party nor an Affiliate of a Party.

 

 
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ARTICLE II
LICENSE; SUBLICENSES
 
2.1.                              License Grant.  RUSH hereby grants to ACORDA
an exclusive (even as to RUSH) license, including the right to grant
sublicenses, under the RUSH Know-How, to develop, make, have made, use, import,
offer for sale, market, commercialize, distribute and sell and otherwise dispose
of Product in the Territory and to use and practice the RUSH Know-How. 
Notwithstanding the foregoing grant, Rush is expressly permitted to use its 4-AP
know how for internal development and research efforts; provided, however, that
(i) such use is for non-commercial academic purposes only, and (ii) that RUSH
shall promptly notify ACORDA of any intellectual property, discovery or
invention, once conceived and/or reduced to practice by RUSH in the course of
conducting or performing such non-commercial activity, which shall be deemed
RUSH Know-How for purposes of this Agreement.
 
2.2.                              Improvements by ACORDA.  All rights and title
to and interest in any Improvement developed or discovered by ACORDA in
connection with the license granted under Section 2.1 above or ACORDA’s
activities hereunder shall be vested solely in ACORDA.  Notwithstanding the
provisions of 2.2, Acorda will continue to have royalty obligations set forth in
Article V, to the extent applicable, with respect to any Product that contains
an Improvement and which includes the Compound as the primary therapeutically
active ingredient.
 
2.3.                              Sublicenses.  ACORDA shall have the right to
grant sublicenses of the licenses granted to it under Section 2.1 of this
Agreement to Affiliates or any Third Party. ACORDA shall provide written notice
to RUSH of any such sublicenses.
 
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
 
3.1.
 Exchange of Information.  Following execution of this Agreement, RUSH shall
utilize good faith reasonable efforts to disclose to ACORDA in English and in
writing, all Rush Know-How not previously available or made available to ACORDA,
in electronic format, where available, and hard copies (or, upon ACORDA’s
request, originals), with the intention to make such information available to
ACORDA as soon as reasonably practicable  Throughout the term of this Agreement,
and in addition to the other communications required under this Agreement, RUSH
shall also promptly disclose to ACORDA in English and in writing on an ongoing
basis all Rush Know-How, and any and all additions or revisions thereto.  To the
extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and
transfers to ACORDA, free and clear of all claims, liens and encumbrances and
contractually imposed restrictions, all right, title and interest in and to the
Rush Orphan Designation.  RUSH shall assist and cooperate with ACORDA in the
submission of any letters or other documents to the FDA required or requested in
connection with the change in ownership of the Rush Orphan Designation from RUSH
to ACORDA. RUSH shall notify ACORDA promptly of any request for, or

 

 
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any expression of interest in using, Compound for research or any other purpose
and shall refer any such requests or expressions of interest directly to ACORDA.
RUSH shall also promptly notify ACORDA of any intellectual property, discovery
or invention, once conceived and/or reduced to practice by RUSH or any employee
or agent of RUSH, in the course of conducting or performing any activity
relating to Compound or Product.

 
 

  3.2.
  Development and Commercialization.  ACORDA shall use commercially reasonable
efforts to develop and commercialize Licensed Product. As used herein,
“commercially reasonable efforts” shall mean efforts and resources normally used
by ACORDA for a product owned by it or to which it has exclusive rights, which
is of similar market potential at a similar stage in its development or product
life, taking into account issues of safety and efficacy, product profile, the
competitiveness of the marketplace, the proprietary position of the compound or
product, the regulatory and reimbursement structure involved, the profitability
of the applicable products, and other relevant factors.  ACORDA shall provide
RUSH with an annual written report summarizing the status of ACORDA’S clinical
development and regulatory activities with respect to Licensed Product, with the
delivery to RUSH of the summary of the annual report to an IND submitted by
ACORDA to the FDA in connection with the periodic reporting requirements of the
IND to be in satisfaction of the foregoing requirement.  The obligations set
forth in this Section 3.2 are expressly conditioned upon the absence of any
serious adverse conditions or event relating to the safety or efficacy of
Compound or Product including the absence of any action by any regulatory
authority limiting the development or commercialization of Compound or Product.

 
 

 
3.3.                              Regulatory Matters.

 

 
(a)
ACORDA shall own, control and retain primary legal responsibility for the
preparation, filing and prosecution of all filings and regulatory applications
required to obtain Regulatory Approvals.  ACORDA shall notify RUSH upon the
receipt of Regulatory Approvals and of the date of First Commercial Sale.

 

 
(b)  
Upon ACORDA’S request, RUSH shall consult and cooperate with ACORDA in
connection with obtaining Regulatory Approval of Product.

 
 

 
3.4.                              Trademark. ACORDA shall select, own and
maintain trademarks for Product in the Territory.

 
ARTICLE IV
CONFIDENTIALITY AND PUBLICITY
 
 

 
4.1.                              Non-Disclosure and Non-Use Obligations.  All
Proprietary Information disclosed by one Party to the other Party hereunder
shall be maintained in confidence and shall not be disclosed to any Third Party
or used for any purpose except as expressly permitted herein without the prior
written consent of the Party that disclosed the Proprietary Information to the
other Party during the term of this Agreement.  The foregoing non-disclosure and
non-use obligations shall not apply to the extent that such Proprietary
Information:

 

 
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  (a)
   is known by the receiving Party at the time of its receipt, and not through a
prior disclosure by the disclosing Party, as documented by business records;

 
 

  (b)
 is or becomes properly in the public domain or knowledge;

 
 

  (c)
 is subsequently disclosed to a receiving Party by a Third Party who may
lawfully do so and is not under an obligation of confidentiality to the
disclosing Party; or

 
 

  (d)
is developed by the receiving Party independently of Proprietary Information
received from the other Party, as documented by research and development
records.

 
 

 
4.2.                              Permitted Disclosure of Proprietary
Information.  Notwithstanding Section 4.1, a Party receiving Proprietary
Information of another Party may disclose such Proprietary Information:

 
 

  (a)
 by ACORDA to governmental or other regulatory agencies in order to obtain
patents or to gain approval to conduct clinical trials or to market Product;

 
 

  (b)
 by ACORDA or its agents, consultants, Affiliates, sublicensees and/or other
Third Parties for the research and development, manufacturing and/or marketing
of the Compound and/or Product (or for such parties to determine their interests
in performing such activities) on the condition that such Third Parties agree to
be bound by the confidentiality obligations consistent with this Agreement; or

 
 

  (c)
  if required to be disclosed by law or court order, provided that notice is
promptly delivered to the non-disclosing Party in order to provide an
opportunity to challenge or limit the disclosure obligations; provided, however,
without limiting any of the foregoing, it is understood that ACORDA or its
Affiliates may make disclosure of this Agreement and the terms hereof in any
filings required by the Securities and Exchange Commission (“SEC”) or any other
governmental agency, may file this Agreement as an exhibit to any filing with
the SEC or such agency and may distribute any such filing in the ordinary course
of its business.

 
 

  4.3.
 Publication.        Neither RUSH nor any Affiliate or employee of or consultant
to RUSH shall make any publication relating to Compound or Product without the
prior consent of ACORDA. If RUSH proposes to submit for written or oral
publication any manuscript, abstract or the like relating to Compound or
Product, it shall first deliver the proposed publication to ACORDA at least
thirty (30) Business Days prior to planned submission. At the request of ACORDA,
the submission of such publication may be delayed for up to fourteen (14) days
in addition to the said thirty Business Days, including for issues of patent
protection or other matters relating to the development of Compound or Product.
If ACORDA requests modifications to the publication, RUSH shall edit such
publication as

 

 
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reasonably necessary to prevent disclosure of trade secret or proprietary
business information prior to submission of the publication or presentation.

 
ARTICLE V
PAYMENTS; ROYALTIES AND REPORTS
 
5.1.
  Up-front License Fee. In consideration of the rights granted by RUSH
hereunder, ACORDA shall pay RUSH an up-front license fee of $200,000 within five
(5) Business Days after the Effective Date.

 
 

5.2.
Milestone Payments. In further consideration of the rights granted by RUSH
hereunder, ACORDA or its designees shall pay RUSH the following milestone
payments, contingent upon occurrence of the specified event, with each milestone
payment to be made no more than once with respect to the achievement of such
milestone (but payable the first time such milestone is achieved) for Licensed
Product:

 
 

 
(a)                                  US $100,000 upon the commencement (first
dosing of the first patient) of the first Phase 3 Clinical Trial;

 
 

 
(b)                                 US $100,000 upon the completion of the first
Phase 3 Clinical Trial;

 
 

 
(c)                                  US $200,000 upon the FDA’s acceptance for
filing of the NDA; and

 
 

 
(d)                                 US $750,000 upon receipt of first written
Regulatory Approval of the NDA for marketing in the United States by the FDA.

 
ACORDA shall notify RUSH in writing within thirty (30) Business Days after the
achievement of each milestone and such notice shall be accompanied by the
appropriate milestone payment. The milestone payments described in this
Section 5.2 shall be payable only upon the initial achievement of each
milestone, and no amounts shall be due hereunder for any subsequent or repeated
achievement of such milestones, regardless of the number of Licensed Products
for which such milestone may be achieved.
 
5.3.
Royalties and Other Payments.

 
5.3.1.                     Royalties
 
(a)                                  Subject to the terms and conditions of this
Agreement, and in further consideration of the rights granted by RUSH hereunder,
ACORDA or its designees shall pay to RUSH royalties during the Base Royalty Term
in an amount equal to (i) two percent (2%) of Net Sales in each Royalty Year in
the United States; and (ii) one percent (1%) of Net Sales in each Royalty Year
in each country in the Territory other than the United States. Royalties on Net
Sales at the rates set forth in this Section 5.3.1(a) shall accrue as of the
date of First Commercial Sale of Product in the applicable country and shall
continue and accrue on Net Sales on a country-by-country basis until the
expiration of the Base Royalty Term in such country. Thereafter, ACORDA shall be
relieved of any royalty payment under this Section 5.3.1(a).
 

 
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(b)                                 Subject to the terms and conditions of this
Agreement, and in further consideration of the rights granted by RUSH hereunder,
ACORDA or its designees shall pay to RUSH royalties during the Reduced Royalty
Term in an amount equal to (i) one percent (1%) of Net Sales in each Royalty
Year in the United States; and (ii) one-half of one percent (.5%) of Net Sales
in each Royalty Year in each country in the Territory other than the United
States.  Royalties on Net Sales at the rates set forth in this Section 5.3.1(b)
shall accrue as of the commencement of the Reduced Royalty Term in the
applicable country and shall continue and accrue on Net Sales on a
country-by-country basis until the expiration of the Reduced Royalty Term in
such country. Thereafter, ACORDA shall be relieved of any royalty payment under
this Agreement.
 
(c)                                  The payment of royalties set forth above
shall be subject to the following conditions:
 

  (A) only one payment shall be due with respect to the same unit of Product;  
      (B) no royalties shall accrue on the disposition of Product by ACORDA,
Affiliates or sublicensees as samples (promotion or otherwise) or as donations
(for example, to non-profit institutions or government agencies) or to clinical
trials or for research and and/or development or for compassionate or similar
use where ACORDA does not receive revenue other than cost recovery; and        
(C) RUSH shall be responsible for payment of any royalties or other obligations
owed by RUSH to any Third Party.

 
 

 
5.3.2.                     Affiliate and Sublicensee Sales.  In the event that
ACORDA transfers Compound or Product to one of its Affiliates or sublicensees,
there shall be no royalty due at the time of transfer.  Subsequent sales of
Product by the Affiliates or sublicensees to Third Parties such as patients,
hospitals, medical institutions, health plans or funds, wholesalers (which are
not sublicensees), pharmacies or other retailers, shall be reported as Net Sales
hereunder.
 
5.3.3.                     Third Party Licenses.  If one or more licenses from a
Third Party or Third Parties are obtained by ACORDA in order to develop, make,
have made, use, sell or import Compound or Product in a particular country,
fifty percent (50%) of any royalties or other payments paid under such Third
Party patent licenses by ACORDA in such country for such Calendar Quarter shall
be creditable against the royalty or other payments payable to RUSH by ACORDA in
such country; provided, however, that the amount credited in any Calendar
Quarter shall not exceed fifty percent (50%) of the royalties that would have
otherwise been payable to RUSH for such Calendar Quarter.
 
5.3.4.                     Combination Product.  Notwithstanding the provisions
of Section 5.3.1, in the event a Product is sold as a combination product with
other biologically active components, Net Sales, for purposes of royalty
payments on the combination product, shall be calculated by multiplying the Net
Sales of that combination product by the
 

 
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fraction A/B, where A is the gross selling price of the Product sold separately
and B is the gross selling price of the combination product.  If no such
separate sales are made, Net Sales for royalty determination shall be calculated
by multiplying Net Sales of the combination product by the fraction C/(C+D),
where C (excluding the fully allocated cost of the other biologically active
component in question) is the fully allocated cost of the Compound and D is the
fully allocated cost of such other biologically active components.
 
 
5.4.                              Reports; Payment of Royalty.  During the term
of the Agreement for so long as royalty payments are due, ACORDA shall furnish
to RUSH a written report for each Calendar Quarter showing the Net Sales of all
Products subject to royalty payments during the reporting period and the
calculation of the royalties payable to RUSH under this Agreement, including
deductions from Net Sales.  Reports shall be due on the forty-fifth (45th) day
following the close of each Calendar Quarter.  Royalties shown to have accrued
by each royalty report, if any, shall be due and payable on the date such report
is due.  ACORDA shall keep complete and accurate records in sufficient detail to
enable the royalties hereunder to be determined.  ACORDA shall retain such
records for twenty-four (24) months after submission of the corresponding
report.

 
 
5.5.                              Audits. Upon the written request of RUSH and
not more than once during the twelve (12) month period next following the
expiration of each Royalty Year during the term of the Agreement, ACORDA shall,
at RUSH’s expense, permit an independent certified public accounting firm
selected by RUSH and reasonably acceptable to ACORDA to have access during
normal business hours, upon thirty (30) days prior notice to ACORDA, to such of
the records of ACORDA as may be reasonably necessary to verify the accuracy of
the royalty reports hereunder for any Royalty Year ending not more than
twenty-four (24) months prior to the date of such request.  The accounting firm
shall provide a written report as soon as practicable, which shall disclose only
whether the royalty reports are correct or incorrect and the specific details
concerning any discrepancies.  This Section 5.5 shall survive the expiration or
termination of this Agreement for a period of two years.

 
5.5.1.                     If such accounting firm concludes that additional
royalties were owed during such period, ACORDA shall pay the additional
royalties within sixty (60) days of the date RUSH delivers to ACORDA such
accounting firm’s written report so concluding; provided however, that, in the
event that ACORDA shall not be in agreement with the conclusion of such report
(a) ACORDA shall not be required to pay such additional royalties and (b) such
matter shall be resolved pursuant to the provisions of Section 9.6 herein.  In
the event such accounting firm concludes that amounts were overpaid by ACORDA
during such period, such over payment will be credited against future royalties;
provided, however, that, in the event that RUSH shall not be in agreement with
the conclusion of such report (x) such matter shall be resolved pursuant to the
provisions of Section 9.6 herein and (y) in the event that the overpayment to
RUSH exceeds royalties due and owing to Rush over the term of the agreement,
RUSH shall reimburse ACORDA within 60 days for any remaining overpayment.  The
fees charged by such accounting firm shall be paid by RUSH; provided, however,
that if an error in favor of RUSH of more than five percent (5%) of the
royalties due hereunder for the period being reviewed is discovered, then
 

 
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ACORDA shall pay the reasonable fees and expenses charged by such accounting
firm.
 
5.5.2.                     Upon the expiration of twenty-four (24) months
following the end of any Royalty Year (subject to tolling of such period during
the pendency of an audit relating to such period under Section 5.5.1 above) the
calculation of royalties payable with respect to such year shall be binding and
conclusive upon RUSH, and ACORDA shall be released from any liability or
accountability with respect to royalties for such year.
 
5.5.3.                     RUSH shall treat all financial information subject to
review under this Section 5.5 in accordance with the confidentiality provisions
of this Agreement.
 
 
5.6.                              Payment Exchange Rate.  All payments to RUSH
under this Agreement shall be made in United States dollars.  In the case of
sales outside the United States, the rate of exchange to be used in computing
Net Sales shall be calculated monthly in accordance with the conversion rates
published in the Wall Street Journal, Eastern edition (if available).

 
 
5.7.                              Tax Withholding.  If laws, rules or
regulations require withholding of income taxes or other taxes imposed upon
payments set forth in this Article V, RUSH shall provide ACORDA, prior to any
such payment, annually or more frequently if required, with all forms or
documentation required by any applicable taxation laws, treaties or agreements
to such withholding or as necessary to claim a benefit thereunder (including,
but not limited to Form W-8BEN or any successor forms) and ACORDA shall make
such withholding payments as required and subtract such withholding payments
from the payments set forth in this Article V. ACORDA will use commercially
reasonable efforts consistent with its usual business practices and cooperate
with RUSH to ensure that any withholding taxes imposed are reduced as far as
possible under the provisions of the current or any future taxation treaties or
agreements between foreign countries.

 
 
5.8.                              Exchange Controls. Notwithstanding any other
provision of this Agreement, if at any time legal restrictions prevent the
prompt remittance of part or all of the royalties with respect to Net Sales in
any country, payment shall be made through such lawful means or methods as
ACORDA may determine.  When in any country the law or regulations prohibit both
the transmittal and deposit of royalties on sales in such a country, royalty
payments shall be suspended for as long as such prohibition is in effect (and
such suspended payments shall not accrue interest), and promptly after such
prohibition ceases to be in effect, all royalties or other payments that ACORDA
or its Affiliates would have been obligated to transmit or deposit, but for the
prohibition, shall be deposited or transmitted, as the case may be, to the
extent allowable (with any interest earned on such suspended royalties which
were placed in an interest-bearing bank account in that country, less any
transactional costs).  If the royalty rate specified in this Agreement should
exceed the permissible rate established in any country, the royalty rate for
sales in such country shall be adjusted to the highest legally permissible or
government-approved rate.

 

 
13

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ARTICLE VI
REPRESENTATIONS AND WARRANTIES
 
 

 
6.1.                              RUSH Representations and Warranties.  RUSH
represents and warrants to ACORDA that as of the Effective Date:

 
 

  (a)
Each of this Agreement and the Side Agreement has been duly executed and
delivered by RUSH and constitutes legal, valid, and binding obligations
enforceable against RUSH in accordance with their respective terms;

 
 

  (b)
no approval, authorization, consent, or other order or action of or filing with
any court, administrative agency or other governmental authority is required for
the execution and delivery by RUSH of this Agreement or the Side Agreement or
the consummation by RUSH of the transactions contemplated hereby or thereby
except such consents or filings as are contemplated by this Agreement;

 
 

  (c)
RUSH has the full corporate power and authority to enter into and deliver this
Agreement and the Side Agreement, to perform and to grant the licenses granted
under Article II hereof and to consummate the transactions contemplated hereby
and by the Side Agreement;  all corporate acts and other proceedings required to
be taken to authorize such execution, delivery, and consummation have been duly
and properly taken and obtained;

 
 

  (d)
With the exception of the Rush/Elan Agreements, which have terminated in their
entirety pursuant to the Side Agreement, RUSH has not previously assigned,
transferred, conveyed or otherwise encumbered its right, title and interest in
the Compound or Product or the RUSH Know-How or entered into any agreement with
any Third Party which is in conflict with the rights granted to ACORDA pursuant
to this Agreement;

 
 

  (e)
RUSH is the sole and exclusive owner of the RUSH Know-How, all of which are free
and clear of any security interests, liens, charges, encumbrances or
restrictions on license, and no Third Party has any claim of ownership or other
rights with respect to the RUSH Know-How, whatsoever, except that RUSH agrees
and acknowledges that the Orphan Designation has been assigned to ACORDA;

 
 

  (f)
RUSH has the sole and exclusive authority to grant the rights and licenses
granted under Article II and, with the exception of the Rush/Elan Agreements,
which have terminated in their entirety pursuant to the Side Agreement,  RUSH
has not previously granted, and will not grant, or engage in any discussions to
grant, during the term of this Agreement, any right, license or interest in and
to the Compound or Product or the RUSH

 

 
14

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Know-How, or any portion thereof, inconsistent with the license granted to
ACORDA herein;

 
 

  (g)
there are no claims, judgments or settlements against or owed by RUSH or pending
or, to the best of its knowledge, threatened claims or litigation relating to
the Compound or the Rush Know-How;

 
 

  (h)
RUSH will use reasonable efforts to disclose to ACORDA all relevant information
known by it regarding the Rush Know-How reasonably related to the activities
contemplated under this Agreement to the extent such Rush know-how has not
previously been disclosed;

 
 

  (i)
  in connection with development of the Rush Know-How, RUSH has complied in all
material respects with applicable U.S. laws and regulations;

 
 

  (j)
 RUSH has not filed and is not the owner in any country in the Territory of any
patents or patent applications or of any certificates of invention or
applications for certificates of invention, relating to Compound or Product; and

 
 

  (k)
With the exception of the Rush/Elan Agreements, which have terminated in their
entirety pursuant to the Side Agreement, there are no contracts, agreements or
any other arrangements between RUSH and any Third Party relating to the
research, development or commercialization of the Compound or Product.

 
 
6.2.                              ACORDA Representations and Warranties.  ACORDA
represents and warrants to RUSH that as of the Effective Date:

 
 

  (a)
Each of this Agreement and the Side Agreement have been duly executed and
delivered by it and constitutes legal, valid, and binding obligations
enforceable against ACORDA in accordance with their respective terms;

 
  (b)
it has full corporate power and authority to execute and deliver this Agreement
and the Side Agreement and to consummate the transactions contemplated hereby
and thereby.  All corporate acts and other proceedings required to be taken to
authorize such execution, delivery, and consummation have been duly and properly
taken and obtained;

 
  (c)
no approval, authorization, consent, or other order or action of or filing with
any court, administrative agency or other governmental authority is required for
the execution and delivery by it of this Agreement or the Side Agreement or the
consummation by it of the transactions contemplated hereby or thereby.

 
 
ARTICLE VII

 
15

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7.1.                              Indemnification.  ACORDA shall defend,
indemnify and hold harmless RUSH from and against any and all loss, cost and
liability, including RUSH’s reasonable attorneys fees and costs (“Losses”),
arising in connection with claims made by Third Parties respecting the
manufacture, sale or use of any Product by such Third Party (“Claims”). RUSH
shall give ACORDA prompt notice of any such Loss or claim, shall cooperate in
its defense, and shall give ACORDA full authority to defend and settle such
claim on RUSH’s behalf.

 
 
7.2.                              The indemnity obligation set forth in
Section 7.1 above shall not apply in the case of Losses or Claims caused by or
based on (i) RUSH’s gross negligence or willful misconduct; (ii) any breach of
this Agreement by RUSH; or (iii) any violation of RUSH’s representations or
warranties hereunder.

 
ARTICLE VIII
TERM AND TERMINATION
 
 
8.1.                              Term and Expiration.  This Agreement shall be
effective as of the Effective Date and unless terminated earlier pursuant to
Section 8.2 below, the term of this Agreement shall continue in effect until
expiration of all royalty or other payment obligations hereunder.

 
 
8.2.                              Termination.

 
 

8.2.1                        Termination for Cause.  Either Party may terminate
this Agreement by notice to the other Party at any time during the term of this
Agreement as follows:
 
 

  (a)
if the other Party is in breach of any material obligation hereunder by causes
and reasons within its control, or has breached, in any material respect, any
representations or warranties set forth in Article VI, and has not cured such
breach within ninety (90) days after notice requesting cure of the breach,
provided, however, that if the breach is not capable of being cured within
ninety (90) days of such written notice, the Agreement may not be terminated so
long as the breaching Party commences and is taking commercially reasonable
actions to cure such breach as promptly as practicable; or

 
 

  (b)
upon the filing or institution of bankruptcy, reorganization, liquidation or
receivership proceedings, or upon an assignment of a substantial portion of the
assets for the benefit of creditors by the other Party; provided, however, in
the case of any involuntary bankruptcy, reorganization, liquidation,
receivership or assignment proceeding such right to terminate shall only become
effective if the Party consents to the involuntary proceeding or such proceeding
is not dismissed within ninety (90) days after the filing thereof.

 
 
 
8.2.2                        Licensee Rights Not Affected.

 

 
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All rights and licenses granted pursuant to this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code
licenses of rights to “intellectual property” as defined under Section 101(35A)
of the Bankruptcy Code.  The Parties agree that ACORDA and RUSH shall retain and
may fully exercise all of their respective rights, remedies and elections under
the Bankruptcy Code.   The Parties further agree that, in the event of the
commencement of a bankruptcy or reorganization case by or against a Party under
the Bankruptcy Code, the other Party shall be entitled to all applicable rights
under Section 365 (including 365(n)) of the Bankruptcy Code.  Upon rejection of
this Agreement by a Party or a trustee in bankruptcy for such Party, pursuant to
Section 365(n), the other Party may elect (i) to treat this Agreement as
terminated by such rejection or (ii) to retain its rights (including any right
to enforce any exclusivity provision of this Agreement) to intellectual property
(including any embodiment of such intellectual property) under this Agreement
and under any agreement supplementary to this Agreement for the duration of this
Agreement and any period for which this Agreement could have been extended by
such other Party, subject, however, to the continued payment of all amounts
owing under Section 5.3 of this Agreement, all of which amounts shall be deemed
to be royalties for purposes of Section 365(n) of the Bankruptcy Code.  Upon
written request to the trustee in bankruptcy or bankrupt Party, the trustee or
Party, as applicable, shall (i) provide to the other Party any intellectual
property (including such embodiment) held by the trustee or the bankrupt Party
and shall provide to the other Party a complete duplicate of (or complete access
to, as appropriate) any such intellectual property and all embodiments of such
intellectual property and (ii) not interfere with the rights of the other Party
to such intellectual property as provided in this Agreement or any agreement
supplementary to this Agreement, including any right to obtain such intellectual
property (or such embodiment or duplicates thereof) from a Third Party.
 
 
8.3.                              Effect of Expiration or Termination. 
Expiration or termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination. ACORDA and its
Affiliates and sublicensees shall have the right to sell or otherwise dispose of
the stock of any Product subject to this Agreement then on hand or in process of
manufacture and ACORDA will continue to pay Rush royalties pursuant to Article V
after the expiration or termination of this Agreement for any such Product
sold.  In addition to any other provisions of this Agreement which by their
terms continue after the expiration of this Agreement, the provision of
Article IV shall survive the expiration or termination of this Agreement and
shall continue in effect for five (5) years from the date of expiration or
termination and the provisions of Article IX shall survive the expiration or
termination of this Agreement.  Upon any termination of this Agreement, each
party shall promptly return to the other party all Proprietary Information
received from the other party (except one copy of which may be retained for
archival purposes).  In addition, any other provision required to interpret and
enforce the Parties’ rights and obligations under this Agreement shall also
survive, but only to the extent required for the full observation and
performance of this Agreement. Any expiration or early termination of this
Agreement shall be without prejudice to the rights of any Party against the
other

 

 
17

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accrued or accruing under this Agreement prior to termination. In the event
ACORDA breaches any of the financial provisions contained in this Agreement, in
lieu of any other remedy that may be available, RUSH shall be entitled to pursue
its remedies at law, but shall not be entitled to injunctive relief.
 
ARTICLE IX
MISCELLANEOUS
 
 
9.1.                              Right to Develop Independently.  Nothing in
this Agreement will impair ACORDA’s right to independently acquire, license,
develop, or have others develop for it, products similar to or performing
functions similar to Product, or similar technology performing similar functions
to the Products or to market and distribute products based on other technology.

 
 

 
9.2.                              Force Majeure.  Neither Party shall be held
liable or responsible to the other Party nor be deemed to have defaulted under
or breached the Agreement for failure or delay in fulfilling or performing any
term of the Agreement during the period of time when such failure or delay is
caused by or results from causes beyond the reasonable control of the affected
Party including, but not limited to, fire, flood, embargo, war, acts of war
(whether war be declared or not), insurrection, riot, civil commotion, strike,
lockout or other labor disturbance, act of God or act, omission or delay in
acting by any governmental authority or the other Party.  The affected Party
shall notify the other Party of such force majeure circumstances as soon as
reasonably practicable.

 
 

 
9.3.                              Assignment.  The Agreement may not be assigned
or otherwise transferred without the prior written consent of the other Party;
provided, however, that ACORDA may assign this Agreement to an Affiliate or in
connection with the transfer or sale of its business or all or substantially all
of its assets related to Compound or Product or in the event of a merger,
consolidation, change in control or similar corporate transaction. Any permitted
assignee shall assume all obligations of its assignor under this Agreement.

 
 

 
9.4.                              Severability.  In the event that any of the
provisions contained in this Agreement are held invalid, illegal or
unenforceable in any respect, the validity, legality and enforceability of the
remaining provisions contained herein shall not in any way be affected or
impaired thereby, unless the absence of the invalidated provision(s) adversely
affect the substantive rights of the Parties.  In such event, the Parties shall
replace the invalid, illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which, insofar as practical, implement the purposes of
this Agreement.

 
 

 
9.5.                              Notices.  All notices or other communications
which are required or permitted hereunder shall be in writing and sufficient if
delivered personally, sent by facsimile (and promptly confirmed by personal
delivery, registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:

 

 
18

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if to ACORDA to:
 
ACORDA THERAPEUTICS, INC.
15 Skyline Drive
Hawthorne, New York 10532
 
Attention:  : President
Fax No.:  914.347.4560
 
 
if to RUSH to:
 
RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER
1725 W. Harrison Street
Chicago, Illinois 60612
Attention: Intellectual Property Office/General Counsel’s Office
Fax No.: 312-942-2055
 
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith.  Any such
communication shall be deemed to have been given when delivered if personally
delivered or sent by facsimile on a Business Day, upon confirmed delivery by
nationally-recognized overnight courier if so delivered and on the third
Business Day following the date of mailing if sent by registered or certified
mail.
 
 
 

  9.6.
Applicable Law and Dispute Resolution.  The Agreement shall be governed by and
construed in accordance with the laws of the United States of America and State
of New York without reference to any rules of conflict of laws.

 
(a)                                  The Parties agree to attempt initially to
solve all claims, disputes, or controversies arising under, out of, or in
connection with this Agreement (a “Dispute”) by conducting good faith
negotiations.  Any Disputes which cannot be resolved by good faith negotiation
within twenty (20) Business Days, shall be referred, by written notice from
either Party to the other, to the Chief Executive Officer of each Party. Such
Chief Executive Officers shall negotiate in good faith to achieve a resolution
of the Dispute referred to them within twenty (20) Business Days after such
notice is received by the Party to whom the notice was sent. If the Chief
Executive Officers are unable to settle the Dispute between themselves within
twenty (20) Business Days, they shall so report to the Parties in writing. The
Dispute shall then be referred to mediation as set forth in the following
subsection (b).
 
(b)                                 Upon the Parties receiving the Chief
Executive Officers’ report that the Dispute referred to them pursuant to
subsection (a) has not been resolved, the Dispute shall be referred to mediation
by written notice from either Party to the other. The mediation shall be
conducted pursuant to the American Arbitration Association (“AAA”) procedures. 
The place of the mediation shall be Chicago, Illinois.  If the Parties have not
reached a settlement within twenty (20) Business Days of the date of the notice
of mediation, the Dispute shall be referred to arbitration pursuant to
subsection (c) below.
 

 
19

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(c)                                  If after the procedures set forth in
subsections (a) and (b) above, the Dispute has not been resolved, a Party shall
decide to institute arbitration proceedings, it shall give written notice to
that effect to the other Party.  The Parties shall refrain from instituting the
arbitration proceedings for a period of sixty (60) days following such notice. 
During such period, the Parties shall continue to make good faith efforts to
amicably resolve the dispute without arbitration.  If the Parties have not
reached a settlement during that period the arbitration proceedings shall go
forward and be governed by the AAA rules then in force. Each such arbitration
shall be conducted by a panel of three arbitrators: one arbitrator shall be
appointed by each of RUSH and ACORDA and the third arbitrator, who shall be the
Chairman of the tribunal, shall be appointed by the two-Party appointed
arbitrators. Any such arbitration shall be held in Chicago, Illinois, USA.
 
The arbitrators shall have the authority to direct the Parties as to the manner
in which the Parties shall resolve the disputed issues, to render a final
decision with respect to such disputed issues, or to grant specific performance
with respect to any such disputed issue.  Judgment upon the award so rendered
may be entered in any court having jurisdiction or application may be made to
such court for judicial acceptance of any award and an order of enforcement, as
the case may be. Nothing in this Section shall be construed to preclude either
Party from seeking provisional remedies, including but not limited to, temporary
restraining orders and preliminary injunctions, from any court of competent
jurisdiction, in order to protect its rights pending arbitration, but such
preliminary relief shall not be sought as a means of avoiding arbitration.   In
no event shall a demand for arbitration be made after the date when institution
of a legal or equitable proceeding based on such claim, dispute or other matter
in question would be barred by the applicable statute of limitations.  Each
Party shall bear its own costs and expenses incurred in connection with any
arbitration proceeding and the Parties shall equally share the cost of the
mediation and arbitration levied by the AAA.
 
Any mediation or arbitration proceeding entered into pursuant to this
Section 9.6 shall be conducted in the English language. Subject to the
foregoing, for purposes of this Agreement, each Party consents, for itself and
its Affiliates, to the jurisdiction of the courts of the State of New York,
county of New York and the U.S. District Court for the Southern District of New
York.
 
9.7.       Entire Agreement.  This Agreement, together with the exhibits and
schedules hereto, contains the entire understanding of the Parties with respect
to the subject matter hereof and supersedes all previous writings and
understandings between the Parties.  This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by all Parties
hereto.
 
9.8.          Independent Contractors.  It is expressly agreed that the Parties
shall be independent contractors and that the relationship between the Parties
shall not constitute a partnership, joint venture or agency. Neither Party shall
have the authority to make any statements, representations or commitments of any
kind, or to take any action, which shall be binding on the other Party, without
the prior consent of such other Party.
 

 
20

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  9.9                                 Waiver.  The waiver by a Party hereto of
any right hereunder or the failure to perform or of a breach by another Party
shall not be deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or otherwise.
 
  9.10.                        Further Assurances.  At any time or from time to
time on and after the Effective Date, RUSH shall at the request of ACORDA (i)
deliver to ACORDA such records, data or other documents consistent with the
provisions of this Agreement, (ii) execute, and deliver or cause to be
delivered, all such consents, documents or further instruments of transfer or
license, and (iii) take or cause to be taken all such actions as ACORDA may
reasonably deem necessary or desirable in order for ACORDA to obtain the full
benefits of this Agreement and the transactions contemplated hereby.
 
  9.11.                        Headings.  The captions to the several Articles
and Sections hereof are not a part of the Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof.
 
  9.12.                        Counterparts.  The Agreement may be executed in
two or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
 
  9.13.                        Use of Names. Except as otherwise provided in
this Agreement, neither Party shall not use the name of the other Party  in
relation to this transaction in any public announcement, press release or other
public document without the consent of the other Party (which consent shall not
be unreasonably withheld or delayed), except as may be required by applicable
law.
 
  9.14.                        LIMITATION OF LIABILITY.  NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR ANY INDIRECT CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.
 

 
21

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
 
 
RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER
 
 
By:
/s/ James T. Frankenbach
     
Name: James T. Frankenbach
   
Title: Senior Vice President
             
ACORDA THERAPEUTICS, INC.
             
By:
/s/ Ron Cohen
     
Name: Ron Cohen, M.D.
   
Title:   President and Chief Executive Officer
 

 

 
22

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[rushschedule171.jpg]

 
23

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SCHEDULE 1.11
 
ELAN PATENT RIGHTS
 
For purposes of this Agreement, Elan Patent Rights shall mean any and all rights
under any and all patents and patent applications now existing, currently
pending or hereafter filed, owned or acquired or licensed by Elan (and/or its
Affiliates) which would be infringed by the manufacture, use or sale of the
Product, the current status of which is set forth below.  Elan Patent Rights
shall also include all continuations, continuations-in-part, divisionals and
re-issues of such patents and patent applications and any patents issuing
thereon and extensions of any patents licensed hereunder.  Elan Patent Rights
shall further include any patents or patent applications covering any improved
methods of making or using the Product invented or acquired by Elan (and/or its
Affiliates) during the term of the Elan/Acorda Agreement and under which Elan
(and/or its Affiliates) has a right to grant a licence under the Elan/Acorda
Agreement, and Elan’s (and/or its Affiliates) interest in any intellectual
property conceived reduced to practice or otherwise developed in connection with
the Project (as defined in the Elan/Acorda Agreement).
 
1806
 
Formulations and their use in the treatment of
neurological diseases
 
Pending:
Canada
Ireland
Japan
 
2054822
3952/90
349324/1991
                         
Issued:
             
Australia
Europe
New Zealand
South Africa
United States
 
657706
484186
240439
91/8711
5370879
5540938
5580580
                 

 

 
24

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EXHIBIT 1.31
 
SIDE AGREEMENT
 
(Filed as Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1,
No. 333-128827, filed on October 5, 2005)
 

 
25