Document:

Exhibit 10.10

 

 

 

LICENSE AGREEMENT

 

by and between

 

RUSH-PRESBYTERIAN-ST.
LUKE’S MEDICAL CENTER

 

and

 

ACORDA THERAPEUTICS,
INC.

 

1

 

Certain
portions of this Exhibit have been omitted pursuant to a request for
confidentiality.

Such
omitted portions, which are marked with brackets [ ] and an asterisk *,
have been separately filed with the Commission.

 

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:

 

2

 

ARTICLE
I

DEFINITIONS

 

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.

 

6

 

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

 

7

 

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:

 

8

 

(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

 

9

 

 

Certain
portions of this Exhibit have been omitted pursuant to a request for
confidentiality.

Such
omitted portions, which are marked with brackets [ ] and an asterisk *,
have been separately filed with the Commission.

 

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
$[* *] upon the commencement (first dosing of the first patient) of the
first Phase 3 Clinical Trial;

 

(b)                                 US
$[* *] upon the completion of the first Phase 3 Clinical Trial;

 

(c)                                  US
$[* *] upon the FDA’s acceptance for filing of the NDA; and

 

(d)                                 US
$[* *] 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) [* *] of Net Sales in each Royalty Year in the United States; and
(ii) [* *] 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).

 

10

 

Certain
portions of this Exhibit have been omitted pursuant to a request for
confidentiality.

Such
omitted portions, which are marked with brackets [ ] and an asterisk *,
have been separately filed with the Commission.

 

(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) [* *]  of Net Sales in
each Royalty Year in the United States; and (ii) [* *] 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, [* *]  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 [* *]  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

 

11

 

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

 

12

 

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

 

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

 

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.

 

15

 

ARTICLE VII

 

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.

 

16

 

8.2.2                        Licensee Rights Not
Affected.

 

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

 

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

 

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

 

(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

 

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

 

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

  	
   

  
	
   

  	
  Title:   President
  and Chief Executive Officer

  	
   

  

 

22

 

SCHEDULE 1.7

 

DIAGRAM OF COMPOUND

 

 

23

 

 

Certain
portions of this Exhibit have been omitted pursuant to a request for
confidentiality.

Such
omitted portions, which are marked with brackets [ ] and an asterisk *,
have been separately filed with the Commission.

 

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 

  	
   

  	
  [* *] 
[* *] 
[* *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Issued:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Australia

  Europe

  New Zealand

  South Africa

  United States

  	
   

  	
  657706

  484186

  240439

  91/8711

  5370879

  5540938

  5580580

  	
   

  

 

24

 

EXHIBIT 1.31

 

SIDE AGREEMENT

 

25Exhibit
10.12

 

DRAFT FOR DISCUSSION PURPOSES ONLY

September 24, 2003

 

RUSH PAYMENTS AGREEMENT

 

REFERENCE IS
MADE to (i) the License Agreement effective 
as of September     , 2003, by and between RUSH-PRESBYTERIAN-ST.
LUKE’S MEDICAL CENTER, a
[                ]
and having its principal office at [1650 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”), including the
Side Agreement attached thereto as Exhibit 1.31 by and among Rush,
Acorda and Elan (as defined below) (the “Side Agreement”), a copy of
which is attached as Exhibit A
hereto (the “Rush/Acorda License”); and (ii) the Amended and Restated
License Agreement effective as of
September      , 2003 by and between Acorda and ELAN CORPORATION, PLC., a public limited
company incorporated under the laws of Ireland and having its registered office
at Lincoln House, Lincoln Place, Dublin 2, Ireland  (“Elan”) (the “Elan/Acorda License”). The Rush/Acorda
License and the Elan/Acorda License are sometimes collectively referred to
herein as the “Novation Agreements” and Elan and Acorda are sometimes referred
to herein as the “Parties”.

 

WHEREAS, in connection with and in consideration of the Novation
Agreements, Acorda and Elan have agreed to enter into this Rush Payments
Agreement with the intention to set forth the respective allocation between the
Parties of certain amounts payable under the Rush/Acorda License and certain
other rights and obligations of the Parties.

 

NOW THEREFORE, in consideration of the premises and the mutual
covenants hereinafter recited and set forth in the Novation Agreements and for
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, and intending to be legally bound, the Parties agree as
follows:

 

1.                                       With
respect to the US $200,000 license fee set forth in Section 5.1 of the
Rush/Acorda License, each of Acorda and Elan shall be responsible for fifty
percent (50%) of such license fee. Accordingly, no later than five (5) Business
Days prior to the date set forth in Section 5.1 of the Rush/Acorda
License, Elan shall pay Acorda US$100,000 as Elan’s 50% share of such payment.

 

2.                                       With
respect to milestone payments that become payable under Section 5.2 of the
Rush/Acorda License, the following shall be applicable:

 

(a)                                  Each
of Acorda and Elan shall be responsible for fifty percent (50%) of any
milestone payments payable to Rush under Section 5.2 (a) or 5.2 (b) of the
Rush/Acorda License. Accordingly, if the milestone events set forth in either
Section 5.2 (a) or Section 5.2 (b) of the Rush/Acorda License are
achieved, (x) Acorda shall so advise Elan in writing no later than twenty (20)
days after achievement of the applicable milestone event, and (y) Elan shall
pay Acorda an amount equal to fifty percent (50%) of the applicable milestone
payment no later than

 

 

twenty five (25) days after achievement of the applicable milestone
event as Elan’s share of such payment; and

 

(b)                                 Elan
shall be responsible for one hundred percent (100%) of any milestone payments
payable to Rush under Section 5.2 (c) of the Rush/Acorda License.
Accordingly, if the milestone event set forth in Section 5.2 (c) of the
Rush/Acorda License is achieved, Acorda shall so advise Elan in writing no
later than twenty (20) days after achievement of the applicable milestone event
and Elan shall pay Acorda an amount equal to one hundred percent (100%) of the
applicable milestone payment no later than twenty five (25) days after
achievement of the applicable milestone event.

 

3.                                       With
respect to the royalties payable under Section 5.3.1 (a) and (b) of the
Rush/Acorda License, Acorda and Elan have agreed that they shall each be
responsible for fifty percent (50%) of such royalties.  Acorda and Elan have implemented such
agreement by eliminating from the Elan/Acorda License the payment by Acorda to
Elan of royalties previously payable by Elan to Rush pursuant to the Rush/Elan
Agreements (as defined in the Side Agreement). 
In addition, (a) during the term of the Rush/Acorda License, Acorda
shall pay to Elan an additional  royalty
of one-half of one percent (.5%) of NSP of the Product sold outside the US; and
(b) commencing in the first calendar quarter that begins after termination or
expiration of Acorda’s royalty obligations to Rush under the Rush/Acorda
License, Acorda shall pay Elan an additional royalty equal to fifty percent
(50%) of the royalty that would have been payable by Acorda to Rush under
Section 5.3.1 of the Rush/Acorda License on such sales of Product (if not
for such termination or expiration) (collectively, the “Additional Royalty”);
provided, however, that  in the event
the provisions of Clause 5.6.2 or Clause 5.6.3 of the Elan/Acorda License are
applicable, any Additional Royalty payable shall be limited to one quarter of
one percent (.25%) of NSP of Product. All payments of the Additional Royalty
shall be made in accordance with the provisions of Clauses 5.6.4, 5.6.5 and
5.6.5 of the Elan/Acorda License, and Article 5.9 of the Elan/Acorda
License, to the extent applicable.

 

4.                                       In
the event that Elan breaches any of its financial obligations and undertakings
under Paragraph 2 of this Rush Payments Agreement, Acorda may offset and credit
the amount of the unpaid financial obligation, together with accrued interest
thereon, against any amounts payable from Acorda to Elan under the Elan/Acorda
License including, without limitation, amounts payable under Section 3.4
of the Elan/Acorda License. In the event that it is determined that Acorda has
incorrectly offset or credited any amounts pursuant to this Paragraph 4, Acorda
shall promptly pay the incorrectly offset or credited amount, together with
accrued interest thereon, to Elan.

 

5.                                       In
the event that Acorda has breached any financial or other curable obligation
under the Rush/Acorda License which breach would give Rush the right, pursuant
to the Section 8.2.1 of the Rush/Acorda License, to terminate the
Rush/Acorda License and, pursuant to the terms of the Side Agreement, Elan has
the right to and remedies such breach (provided, however, that Elan shall not
have the right to remedy such breach if such breach has been consented to by
Elan or is primarily due to the fault of Elan or if Elan is in breach of the
terms of this Rush Payments Agreement or the Elan/Acorda License), Elan may
charge Acorda an amount equal to

 

2

 

the amount so paid by Elan to Rush to remedy such breach on behalf of
Acorda. In the event that it is determined that Elan has incorrectly charged
any amounts to Acorda pursuant to this Paragraph 5 and Acorda has paid such
amounts, Elan shall promptly repay to Acorda the incorrectly charged and paid
amount, together with accrued interest thereon.

 

6.                                       In
the event that Rush terminates the Rush/Acorda License pursuant to
Section 8.2.1 thereof as a result of a breach by Acorda and, pursuant to
the terms of the Side Agreement, Elan has the right to and elects to assume the
rights and obligations of Acorda under the Rush/Acorda License (provided,
however, that Elan shall not have the right to assume such rights and
obligations if such breach has been consented to by Elan, is primarily due to
the fault of Elan or if Elan is in breach of the terms of this Rush Payments
Agreement or the Elan/Acorda License), Elan may charge Acorda an amount equal
to any amounts or financial obligations so paid or incurred by Elan to Rush
pursuant to Elan’s assumption of Acorda’s obligations under the Rush/Acorda
License.

 

 7.            Acorda agrees to indemnify Elan from and against any
losses and liability arising from any claims made by Rush against Elan after
the Effective Date resulting primarily from any acts of Acorda under the
Rush/Acorda License.   Elan shall give
Acorda prompt notice of any such loss or liability, shall cooperate in its
defense, and shall give Acorda full authority to defend and settle such claim
on Elan’s behalf. This indemnity obligation shall not apply in the case of
losses primarily caused by or based on (i) Elan’s acts or omissions; or (ii)
any breach of this Rush Payments Agreement, the Side Agreement or the
Elan/Acorda License by Elan.

 

                                                In
the event Elan has the right to and elects to cure any Acorda breach of, or
assumes the rights and obligations of Acorda under the, Rush/Acorda License in
accordance with the terms of the Side Agreement and this Rush Payments
Agreement, Elan agrees to indemnify Acorda from and against any losses and liability
arising from any claims made by Rush against Acorda resulting from any acts of
Elan after the date that Elan cures 
such breach or assumes Acorda’s obligations under the Rush/Acorda
License.  Acorda shall give Elan prompt
notice of any such loss or liability, shall cooperate in its defense, and shall
give Elan full authority to defend and settle such claim on Acorda’s behalf.
This indemnity obligation shall not apply in the case of losses primarily
caused by or based on (i) Acorda’s acts or omissions; or (ii) any breach of
this Rush Payments Agreement, the Side Agreement or the Elan/Acorda License by
Acorda.

 

8.                                       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:

 

	
  if to Acorda to:

  	
   

  	
  ACORDA THERAPEUTICS, INC..

  
	
   

  	
   

  	
  15 Skyline Drive

  
	
   

  	
   

  	
  Hawthorne, New York 10532

  
	
   

  	
   

  	
  Attention:  President

  
	
   

  	
   

  	
  Fax No.:
  914.347.4560

  

 

3

 

	
  if to Elan to:

  	
   

  	
  ELAN CORPORATION, PLC.

  
	
   

  	
   

  	
  c/o Elan International Services Ltd.

  
	
   

  	
   

  	
  102 St. James Court

  
	
   

  	
   

  	
  Flatts,

  
	
   

  	
   

  	
  Smiths FL04 Bermuda

  
	
   

  	
   

  	
  Attention: Secretary

  
	
   

  	
   

  	
  Fax No: +1 441 292 2224

  

 

 

9.                                       This
Rush Payments Agreement shall be effective as of  the date set forth below 
(“Effective Date”), and shall be governed by the laws of the State of
New York without reference to any rules of conflict of laws.  Any disputes under this Agreement shall be
governed by the dispute resolution provisions of Article 12.14 of the
Elan/Acorda License.

 

10.                                 This
Rush Payments 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.

 

IN WITNESS
WHEREOF, the Parties have executed this Rush Payments Agreement as of September       ,
2003.

 

 

	
  ACORDA THERAPEUTICS, INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Ron
  Cohen

  	
   

  	
   

  
	
   

  	
  Name: Ron Cohen

  	
   

  
	
   

  	
  Title:   President and Chief
  Executive Officer

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  ELAN CORPORATION, PLC.

  	
   

  
	
   

  	
   

  	
   

  
	
  MONKSLAND HOLDING BV

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Pieter
  Bosse

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Klaas
  vanBlanken

  	
   

  	
   

  
	
   

  	
  Name: Monksland Holding BV

  	
   

  
	
   

  	
  Title: Proxyholder

  	
   

  

 

4

 

EXHIBIT A

RUSH/ACORDA LICENSE

 

5

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