Exhibit
10.20


 


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.


 


AMENDED
AND RESTATED LICENSE AGREEMENT


 


by and between


 


CANADIAN
SPINAL RESEARCH ORGANIZATION


 


and


 


ACORDA
THERAPEUTICS, INC.


 












 


THIS AMENDED AND RESTATED LICENSE AGREEMENT made as
of  August 1, 2003  (the “Restatement Date”), by and between CANADIAN SPINAL RESEARCH ORGANIZATION, a not-for-profit
corporation organized and existing under the laws of Ontario and having its
principal office at 120 Newkirk Road, Unit 2, Richmond Hill, Ontario, L4C 9S7
(“CSRO”) and ACORDA THERAPEUTICS, INC., a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at  16
Skyline Drive, Hawthorne, New York 10532 (“ACORDA”).


 


W I T N E S S E T H:


 


WHEREAS, CSRO owns or has rights to certain Patent
Assets and Know How (each as defined herein) relating to the use of
4-aminopyridine (“4-AP”) in the reduction of chronic pain and spasticity in a
spinal cord injured patient;


 


WHEREAS, CSRO, Purdue and McMaster have entered into
that certain Inter-Institutional Agreement, effective as of October 18, 1993 (the
“Inter-Institutional Agreement”), pursuant to which CSRO acquired the sole
authority to license rights to any patents included in the Patent Assets;


 


WHEREAS, pursuant to the Assignments, CSRO obtained an
Assignment from the Inventors of the Patent Assets (all as defined herein);


 


WHEREAS, pursuant to a License Agreement (the “1995
Agreement”), effective August 9, 1995 (the “1995 Agreement Effective Date”),
between CSRO and ACORDA, CSRO granted ACORDA an exclusive license under the
Patent Assets; and


 


WHEREAS, the Parties agree that the 1995 Agreement
should be amended and restated to reflect the intentions of the Parties,
effective as of the 1995 Agreement Effective Date, except where indicated to be
effective as of the Restatement Date;


 


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 that
the 1995 Agreement, and all of the terms, conditions and provisions of the 1995
Agreement, are hereby superceded and replaced in their entirety by this
Agreement and the terms, conditions and provisions hereof, effective as of the
1995 Agreement Effective Date, as follows:


 


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.                              “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,


 


2












 


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.


 


1.2.                              “Assignment(s)”
shall mean the Assignments from the Inventors to CSRO of the Patent Assets
dated October 16 and October 20, 1996 and filed with the United States Patent
and Trademark Office on or about November 11, 1996 in the forms attached hereto
as Exhibit 1.2.


 


1.3.                              “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.


 


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


 


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


 


1.6.                              “Compound”
shall mean the chemical compound known as 4-aminopyridine, as diagrammed on Schedule
1.6 hereto, and any other compounds disclosed, covered or included in the
Patent Assets.


 


1.7.                              “CSRO
Intellectual Property” shall mean the Patent Assets and Know-How.


 


1.8.                              “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


 


(a)                                  relate
to Compound or Product; and


 


(b)                                 are
owned by CSRO or are in CSRO’s possession or control and as to which CSRO has
the right to license or sublicense to Third Parties.


 


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


 


1.9.                              “Effective
Date” shall mean the 1995 Agreement Effective Date.


 


1.10.                        “First
Commercial Sale” shall mean the first 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


 


3












 


 test marketing,
clinical trial purposes or compassionate or similar use shall not be deemed to
constitute a First Commercial Sale.


 


1.11.                        “GAAP” means United
States generally accepted accounting principles, consistently applied.


 


1.12.                        “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.


 


1.13.                        “Inventors” shall mean
Robert R. Hansebout and Andrew R. Blight.


 


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


 


(i)                                                  reasonable and customary trade,
cash and quantity discounts and rebates;


 


(ii)                                               recalls, credits and allowances on
account of returned or rejected Product, including allowance for breakage or
spoilage;


 


(iii)                                            legally allowed 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, 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.


 


Sales or other
transfers between ACORDA and its Affiliates or sublicensees 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 or
sublicensees.


 


1.15.                        “Party” shall mean CSRO
or ACORDA.


 


4












 


1.16.                        “Patent Assets” shall
mean the patents and patent applications which as of the Effective Date or at
any time during the term of this Agreement


 


(a)                                  are
owned or controlled by CSRO or which CSRO through license or otherwise has or
acquires rights from a Third Party, and


 


(b)                                 relate
to Compound, Product or any Improvement, including but not limited to methods
of their development, manufacture, use, or otherwise relate to Know-How,
including all certificates of invention and applications for certificates of
invention, substitutions, divisions, continuations, continuations-in-part,
patents issuing thereon or reissues or reexaminations or extensions thereof and
any and all foreign patents and patent applications corresponding thereto,
supplementary protection certificates or the like of any such patents and
current and future patent applications, including but not limited to the
patents and patent applications listed on Schedule 1.16 hereto and the
patents and patent applications included in the definition of Patent Rights
under the Inter-Institutional Agreement, and any counterparts thereof which
have been or may be filed in other countries.


 


1.17.                        “Product” shall mean any
product in final form for commercial sale (or, where the context so indicates,
the product being tested in clinical trials), which contains Compound as at
least one of the therapeutically active ingredients in all dosage forms and
package configurations for any indication.


 


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


 


1.19.                        “Regulatory Approval”
means 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.


 


1.20.                         “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, each successive Calendar Year.


 


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


 


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


 


5












 


1.23.                        “Valid Claim” means a
claim of an issued and unexpired patent included within the Patent Assets,
which has not been revoked or held unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, and which has not
been disclaimed, denied or admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.


 


ARTICLE
II

LICENSE; SUBLICENSES


 


2.1.                              License
Grant.  CSRO hereby grants to ACORDA
an exclusive (even as to CSRO) license under the CSRO Intellectual Property,
including the right to grant sublicenses, to develop, make, have made, use,
import, offer for sale, market, commercialize, distribute and sell and
otherwise dispose of Compound and Product in the Territory.  CSRO reserves the right to practice the
Patent Assets for its own internal research and educational purposes; provided,
however, that such use is for non-commercial academic purposes only and for no
other purpose.


 


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.


 


2.3.                              a.
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 advise CSRO, on a
confidential basis, of any sublicense granted by it.


 


ARTICLE
III

EXCHANGE OF INFORMATION; REGULATORY MATTERS


 


3.1.                              Exchange
of Information.  Throughout the term
of this Agreement, and in addition to the other communications required under
this Agreement, CSRO shall promptly disclose to ACORDA in writing on an ongoing
basis all CSRO Intellectual Property related to the Compound or Product, and
any and all additions or revisions thereto. ACORDA shall provide CSRO with an
annual written report summarizing the status of ACORDA’s clinical development
and regulatory activities with respect to Compound and Product by delivering to
CSRO the summary of the annual report to the investigational new drug
application relating to the use of Compound and Product submitted by ACORDA to
the U.S. Food and Drug Administration in connection with the periodic reporting
requirements of such investigational new drug application. Any disclosures
contained in such reports shall be deemed Proprietary Information and shall
remain the intellectual property of ACORDA.


 


3.2.                              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


 


6












 


promptly notify CSRO upon the receipt of Regulatory
Approvals and of the date of First Commercial Sale.


 


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


 


3.3.                              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 and Know-how 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:


 


(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)                                  to
governmental or other regulatory agencies in order to obtain patents pursuant
to this Agreement, or to gain approval to conduct clinical trials or to market
Product, but such disclosure may be only to the extent reasonably necessary to
obtain such patents or authorizations


 


(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


 


7












 


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.


 


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.


 


4.3.                              Publication.    In
the event CSRO or any Affiliate of or consultant to CSRO wishes to make a
publication relating to Compound or Product, it shall deliver to ACORDA a copy
of the proposed publication or an outline of the oral disclosure at least sixty
(60) Business Days prior to submission or presentation, such that any issue of
patent protection can be resolved in accordance with the terms of this
Agreement.


 


4.4.                              Confidential
Terms.    Except as expressly provided herein, each Party
agrees not to disclose any terms of this Agreement to any Third Party without
the consent of the other party, except as required by securities or other
applicable laws, to prospective investors to such party’s accountants,
attorneys and other professional advisors. 
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.


 


ARTICLE V
 ROYALTIES AND REPORTS


 


5.1.                              Royalties.


 


5.1.1                        Royalty Payments.


 


(i)                                                                                     Subject
to the terms and conditions of this Agreement, and in consideration of the
rights granted by CSRO hereunder, ACORDA shall pay to CSRO royalties in an
amount equal to [**] of Net Sales in each country in the Territory where
the manufacture, use or sale of Product would, absent the license granted
hereunder, infringe one or more Valid Claims in such country.


 


(ii)                                                                                  Royalties
on Net Sales at the rate set forth in (i) above 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 earlier of (A)
the expiration of the last to expire Patent Asset in such country or (B) ten
(10) years following the date of First Commercial Sale of Product in such country.  Thereafter, ACORDA shall be relieved of any
royalty payment under this Agreement.


 


(iii)                                                                               The
payment of royalties set forth above shall be subject to the following
conditions:  


 


8












 


(A)                                                                              only
one payment shall be due with respect to the same unit of Product;


 


(B)                                                                                no
multiple royalties shall be payable because any Product, or its manufacture,
sale or use is covered by more than one Valid Claim;


 


(C)                                                                                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; and


 


(D)                                                                               CSRO
shall be responsible for payment of any royalties or other obligations owed by
CSRO to any Third Party, including without limitation, pursuant to the
Inter-Institutional Agreement.


 


5.1.2                        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.


 


5.1.3                        Compulsory Licenses.  If a compulsory license is granted to a Third
Party with respect to Product in any country in the Territory with a royalty
rate lower than the royalty rate provided by Section 5.1.1, then the
royalty rate to be paid by ACORDA on Net Sales in that country under Section
5.1.1 shall be reduced to the rate paid by the compulsory Third Party licensee.


 


5.1.4                        Combination Product.  Notwithstanding the provisions of Section
5.1.1, 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 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 by ACORDA or its Affiliates or sublicensees, 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.


 


5.2.                              Reports;
Payment of Royalty.  During the term
of the Agreement for so long as royalty payments are due, ACORDA shall furnish to
CSRO a written report for each Calendar Quarter showing the Net Sales of all
Products subject to royalty payments during the


 


9












 


reporting period and the royalties payable to CSRO
under this Agreement.  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 the submission of the
corresponding report.


 


5.3.                              Audits.  Upon the written request of CSRO 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 CSRO’s
expense, permit an independent certified public accounting firm selected by
CSRO 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 disclose to CSRO only whether the royalty
reports are correct or incorrect and the specific details concerning any
discrepancies.  This Section 5.3 shall
survive the expiration or termination of this Agreement for a period of two
years.


 


5.3.1                        If such accounting firm
concludes that additional royalties were owed during such period, ACORDA shall
promptly pay the additional royalties within sixty (60) days of the date CSRO
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 10.7 herein.  In
the event such accounting firm concludes that amounts were overpaid by ACORDA
during such period, CSRO shall repay ACORDA the amount of such overpayment within
sixty (60) days of the date CSRO delivers to ACORDA such accounting firm’s
written report so concluding, provided, however, that, in the event that CSRO
shall not be in agreement with the conclusion of such report (a) CSRO shall not
be required to repay such overpayment and (b) such matter shall be resolved
pursuant to the provisions of Section 10.7 herein. The fees charged by such
accounting firm shall be paid by CSRO; provided, however, that if an error in
favor of CSRO of more than the greater of (i) $100,000 or (ii) ten percent
(10%) of the royalties due hereunder for the period being reviewed is
discovered, then the fees and expenses of the accounting firm shall be paid by
ACORDA. Payments of additional royalties under this Section 5.3.1 shall be made
with interest from the date such amounts were due, at the prime rate reported
by Chase Manhattan Bank, New York, New York.


 


5.3.2                        Upon the expiration of
twenty-four (24) months following the end of any Royalty Year the calculation
of royalties payable with respect to such year shall be binding and conclusive
upon CSRO, and ACORDA shall be released from any liability or accountability
with respect to royalties for such year.


 


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.


 


5.3.3                        CSRO shall treat all financial
information subject to review under this Section 5.3. in accordance with the
confidentiality provisions of this Agreement.


 


5.4.                              Payment
Exchange Rate.  All payments to CSRO
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).


 


5.5.                              Tax
Withholding.  If laws, rules or
regulations require withholding of income taxes or other taxes imposed upon
payments set forth in this Article V, CSRO 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 CSRO 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.


 


5.6.                              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.


 


5.7.                              Other
Payments.  The parties hereto
acknowledge that, in further consideration of the rights granted by CSRO
hereunder, ACORDA had issued to CSRO on the Effective Date warrants, dated August
9, 1995, to purchase up to an aggregate of 60,000 shares of common stock of
ACORDA which warrants have since been exercised in full.


 


ARTICLE
VI

REPRESENTATIONS AND WARRANTIES


 


6.1.                              CSRO
Representations and Warranties.  CSRO
represents and warrants to ACORDA that as of the Restatement Date:


 


11












 


(a)                                  this
Agreement has been duly executed and delivered by CSRO and constitutes legal,
valid, and binding obligations enforceable against CSRO in accordance with its
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 CSRO of this Agreement or the consummation by
CSRO of the transactions contemplated hereby;


 


(c)                                  CSRO
has the full corporate power and authority to enter into and deliver this
Agreement, to perform and to grant the licenses granted under Article II hereof
and to consummate the transactions contemplated hereby;  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)                                 the
issued patents included in the Patent Assets are valid and enforceable over any
references or prior art known to CSRO or its agents, taken alone or in
combination;


 


(e)                                  CSRO
has not previously assigned, transferred, conveyed or otherwise encumbered its
right, title and interest in the CSRO Intellectual Property or entered into any
agreement with any Third Party which is in conflict with the rights granted to
ACORDA pursuant to this Agreement;


 


(f)                                    CSRO
is the sole owner of the CSRO Intellectual Property, all of which is free and
clear of any security interests, liens, charges, encumbrances or restrictions
on license, and no other person, corporate or other private entity, or
governmental or university entity or subdivision thereof, including without
limitation, McMaster or Purdue, has any claim of ownership with respect to the
CSRO Intellectual Property, whatsoever; the Assignments are valid and in full
force and effect as of the Restatement Date and CSRO is not aware of any claims
challenging the validity of the Assignments;


 


(g)                                 CSRO  has disclosed to ACORDA the complete texts of
all Patent Assets as well as all information received by CSRO concerning the
institution or possible institution of any interference, opposition,
re-examination, reissue, revocation, nullification, or any official proceeding
involving a Patent Asset, and that it will continue such disclosure with
respect to new events during the term of the Agreement;


 


(h)                                 CSRO
has the sole and exclusive authority to grant the rights and licenses granted
under Article II and CSRO 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 CSRO Intellectual


 


12












 


Property, or any portion thereof, inconsistent with the
license granted to ACORDA herein;


 


(i)                                     Schedule
1.16 is a complete and accurate list of all patents and patent applications in
the Territory relating to Compound or Product owned by CSRO or to which CSRO
has the right to license;


 


(j)                                     there
are no claims, judgments or settlements against or owed by CSRO or pending or,
to the best of its knowledge, threatened claims or litigation relating to the
Patent Assets;


 


(k)                                  CSRO
has disclosed to ACORDA all relevant information known by it regarding the CSRO
Intellectual Property reasonably related to the activities contemplated under
this Agreement;


 


(l)                                     no
contract research organization, corporation, business entity or individual
which have been involved in any studies conducted for the purpose of obtaining
regulatory approvals have been debarred individuals or entities within the
meaning of 21 U.S.C. section 335(a) or (b);


 


(m)                               in
connection with development of Compound and Product, CSRO has complied in all
material respects with applicable U.S. laws and regulations;


 


(n)                                 CSRO
has not entered into any contracts, agreements and other arrangements with any
Third Parties relating to the research, development or commercialization of the
Compound or Product; and


 


(o)                                 Attached
as Exhibit 6.1(o) is a true and complete copy of the Inter-Institutional
Agreement, including all supplements thereto and modifications or amendments
thereof.  CSRO is not, and to the best of
its knowledge, neither Purdue or McMaster is, in default under or in breach of
any terms or provisions of the Inter-Institutional Agreement and such agreement
is in full force and effect as of the date hereof.  During the term of this Agreement, CSRO shall
not amend, modify, terminate or cause a default under the Inter-Institutional
Agreement. In the event that CSRO receives notice from either Purdue or
McMaster or any other Third Party that CSRO has committed a breach of its
obligations under the Inter-Institutional Agreement, or if CSRO anticipates
such breach, or any other claim that may give rise to a right by any Third
Party to terminate or otherwise diminish CSRO’s rights to the Patent Assets
and/or otherwise diminish CSRO’s ability to perform its obligations under this
Agreement, CSRO shall immediately notify ACORDA of such situation, and CSRO
shall promptly cure such breach. 
However, if CSRO is unable to cure such breach, CSRO shall, to the
extent possible, permit ACORDA to cure such breach and to negotiate directly
with Purdue or McMaster or any other such Third Party.


 


13












 


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


 


(a)                                  this
Agreement has been duly executed and delivered by it and constitutes legal,
valid, and binding obligations enforceable against it in accordance with its
terms;


 


(b)                                 it
has full corporate power and authority to execute and deliver this Agreement
and to consummate the transactions contemplated hereby.  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; and


 


(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 consummation by
it of the transactions contemplated hereby.


 


ARTICLE
VII

PATENT MATTERS


 


7.1.                              Filing,
Prosecution and Maintenance of Patent Applications or Patents. ACORDA shall
file, prosecute and maintain the Patent Assets in CSRO’s name and shall be
responsible for the payment of all patent prosecution and maintenance costs.
Upon ACORDA’s request, CSRO shall reasonably cooperate in the filing,
prosecution or maintenance of such patent application or patent. If ACORDA
elects not to file, prosecute or maintain a patent application or patent
included in the Patent Assets, it shall provide CSRO with written advance
notice sufficient to avoid any loss or forfeiture, and CSRO shall have the
right, but not the obligation, at its sole expense, to file, prosecute or
maintain such patent application or patent in CSRO’s name. Thereafter, ACORDA’s
royalty obligations related to that Patent Asset shall terminate and such
patent or patent application shall no longer be deemed a Patent Asset. The
responsible Party under this Section 7.1 shall solicit the other Party’s review
of the nature and text of such patent applications and important prosecution
matters related thereto in reasonably sufficient time prior to filing thereof,
and the responsible Party shall take into account the other Party’s reasonable
comments related thereto.  ACORDA shall
inform CSRO of any significant developments in the prosecution of pending
patent applications included in the Patent Assets, including the issuance of
any final office actions, allowance of claims, or grant of any domestic or
foreign patent based thereon.


 


7.2.                              Patent
Office Proceedings.  Each Party shall
inform the other Party of any request for, filing, or declaration of any
proceeding before a patent office seeking to protest, oppose, cancel,
reexamine, declare an interference proceeding, initiate a conflicts proceeding,
or analogous process involving a patent application or patent included in the
Patent Assets.  ACORDA shall have the
option to conduct any such proceedings relating to the Patent Assets, and may
offset any expenses incurred therein against royalties due to CSRO


 


14












 


under this Agreement. Each Party thereafter shall
cooperate with the other with respect to any such patent office proceedings.


 


7.3.                              Enforcement
and Defense.


 


(a)                                  Each
Party shall promptly give the other Party notice of any infringement in the
Territory of any patent application or patent included in the Patent Assets
that comes to such Party’s attention. 
The Parties will thereafter consult and cooperate fully to determine a
course of action, including, without limitation, the commencement of legal
action by any Party.  However, ACORDA
shall have the first right to initiate and prosecute such legal action and in
the name of CSRO and ACORDA, or to control the defense of any declaratory
judgment action relating to Patent Assets. 
The initiation and prosecution of such legal action will be at ACORDA’s
expense; provided, however, that ACORDA shall be entitled to offset fifty
percent (50%) of amounts expended in connection with such action against
royalties due to CSRO under this Agreement. 
ACORDA shall promptly inform CSRO if ACORDA elects not to exercise such
first right, and CSRO thereafter shall have the right either to initiate and
prosecute such action or to control the defense of such declaratory judgment
action in the name of CSRO and, if necessary, ACORDA.  In no event shall ACORDA be obligated to
enforce or defend any of the Patent Assets.


 


(b)                                 If
ACORDA elects not to initiate and prosecute an infringement or defend a
declaratory judgment action in any country in the Territory as provided in
Subsection 7.3 (a), and CSRO elects to do so, the cost of any agreed-upon
course of action, including the costs of any legal action commenced or any
declaratory judgment action defended, shall be borne solely by CSRO.


 


(c)                                  For
any such legal action or defense, in the event that any Party is unable to
initiate, prosecute, or defend such action solely in its own name, the other
Party will join such action voluntarily and will execute all documents
necessary for the Party to prosecute, defend and maintain such action.  In connection with any such action, the
Parties will cooperate and will provide each other with any information or
assistance that either reasonably may request.


 


(d)                                 Any
recovery obtained by ACORDA or CSRO shall be shared as follows:


 


(i)                                    the Party that initiated and
prosecuted, or maintained the defense of, the action shall recoup all of its
costs and expenses (including reasonable attorneys’ fees) incurred in
connection with the action, whether the recovery is by settlement or otherwise;


 


15












 


(ii)                                 the other Party then shall, to the
extent possible, recover its costs and expenses (including reasonable
attorneys’ fees) incurred in connection with the action;


 


(iii)                              if CSRO initiated and prosecuted, or maintained
the defense of, the action, the amount of any recovery remaining then shall be
retained by CSRO; and


 


(iv)                             if ACORDA initiated and prosecuted, or
maintained the defense of, the action, the amount of any recovery remaining
shall be retained by ACORDA, except that CSRO shall receive a portion
equivalent to the royalties it would have received in accordance with the terms
of this Agreement if such amount were deemed Net Sales.


 


(e)                                  If
the practice by ACORDA of the license granted herein results in any allegation
or claim of infringement of an intellectual property right of a Third Party
against ACORDA, ACORDA shall have the exclusive right but not the obligation to
defend such claim, suit or authority to settle such suit; provided, however,
CSRO shall cooperate with ACORDA’s reasonable request, in connection with the
defense of such claim or suit.  ACORDA
shall be entitled to offset any amounts expended in connection with such
proceeding, including attorneys’ fees and professional fees, against any royalties
it would otherwise owe CSRO under this Agreement, up to a maximum of fifty
percent (50%) of the royalties due.


 


(f)                                    CSRO
shall inform ACORDA of any certification regarding any Patent Assets it has
received pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)
or under Canada’s Patented Medicines (Notice of Compliance) Regulations Article
5 and shall provide ACORDA with a copy of such certification within five (5)
days of receipt.  CSRO’s and ACORDA’s
rights with respect to the initiation and prosecution, or defense, of any legal
action as a result of such certification or any recovery obtained as a result
of such legal action shall be allocated as defined in Subsections 7.3(d) (i)
through (iv); provided, however, that ACORDA shall exercise the first right to
initiate and prosecute, or defend, any action and shall inform CSRO of such
decision within fifteen (15) days of receipt of the certification, after which
time, if ACORDA has not advised CSRO of its intention to initiate and prosecute,
or defend, such action, CSRO shall have the right to initiate and prosecute, or
defend, such action.


 


7.4.                              Patent
Term Extensions or Restorations and Supplemental Protection Certificates.  The Parties shall cooperate with each other
in obtaining patent term extensions or restorations or supplemental protection
certificates or their equivalents in any country in the Territory where
applicable and where desired by ACORDA. 
If elections with respect to obtaining such extension or supplemental
protection certificates are to be made, ACORDA shall have the right to make the
election and CSRO shall abide by such election. CSRO shall


 


16












 


notify ACORDA of (a) the issuance of each U.S. patent
included within the Patent Assets, giving the date of issue and patent number
for each such patent, and (b) each notice pertaining to any patent included
within the Patent Assets pursuant to the United States Drug Price Competition
and Patent Term Restoration Act of 1984 (hereinafter called the “1984 Act”),
including notices pursuant to §§ 101 and 103 of the 1984 Act from persons who
have filed an abbreviated new drug application (“ANDA”).  Such notices shall be given promptly, but in
any event within five (5) calendar days of each such patent’s date of issue or
receipt of each such notice pursuant to the 1984 Act, whichever is
applicable.  The Party responsible for
filing shall notify the other Party of each filing for patent term extension or
restoration under the 1984 Act, any allegations of failure to show due
diligence and all awards of patent term restoration (extensions) with respect
to the Patent Assets.  Likewise, the
responsible Party shall inform the other Party of patent extensions in the rest
of the world regarding any Product.


 


ARTICLE
VIII

INDEMNIFICATION


 


8.1.                              ACORDA
Indemnification.  ACORDA shall indemnify,
defend and hold CSRO harmless from and against any and all liabilities,
damages, losses, costs or expenses (including reasonable attorney’s and
professional fees and other expenses of litigation and/or arbitration)
(collectively, “Losses”) resulting from (i) a claim, suit or proceeding brought
by a Third Party against CSRO, arising from, or occurring as a result of,
activities performed by ACORDA or its sublicensees in connection with the use,
development, manufacture or sale of any Product or Compound, except to the
extent caused by the negligence or willful misconduct of CSRO; or (ii) a breach
of ACORDA’s representations and warranties contained in Article VI.  CSRO shall promptly notify ACORDA of any Loss
for which CSRO intends to claim such indemnification, and cooperate fully with
ACORDA in the investigation, conduct and defense of any claim covered by this
Section 8.1 and provide full information with respect thereto.


 


8.2.                              CSRO
Indemnification.  CSRO shall
indemnify, defend and hold ACORDA harmless from and against any and all Losses
resulting from the negligence or willful misconduct of CSRO or a breach of
CSRO’s representations and warranties contained in Article VI.  ACORDA shall promptly notify CSRO of any Loss
for which CSRO intends to claim such indemnification, and cooperate fully with
ACORDA in the investigation, conduct and defense of any claim covered by this
Section 8.2 and provide full information with respect thereto.


 


ARTICLE
IX

TERM AND TERMINATION


 


9.1.                              Term
and Expiration.  This Agreement shall
be effective as of the Effective Date and unless terminated earlier pursuant to
Section 9.2 and 9.3 below, the term of this Agreement shall continue in effect
until expiration of all royalty or other payment obligations hereunder.   Expiration of this Agreement shall not
preclude ACORDA from continuing to make, use or sell Product in the Territory
without further compensation to CSRO.


 


17












 


9.2.                              Termination
by Notice.  Notwithstanding anything
contained herein to the contrary, ACORDA shall have the right to terminate this
Agreement at any time by giving thirty (30) days advance written notice to CSRO.  Except as set forth in this Agreement, in the
event of such termination, (i) the rights and obligations hereunder, excluding
any payment obligation that has accrued as of the termination date and
excluding rights and obligations relating to confidentiality, shall terminate
immediately, and (ii) the provisions of Section 9.4 shall be applicable.


 


9.3.                              Termination.


 


9.3.1                        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 sixty (60) days after the filing thereof.


 


9.3.2                        Licensee Rights Not Affected.


 


(a)                                  In
the event ACORDA terminates this Agreement under Section 9.3.1(b), or this Agreement
is otherwise terminated under Section 9.3.1(b), or CSRO is a debtor in a
bankruptcy proceeding, whether voluntary or involuntary, all rights and
licenses granted pursuant to this Agreement are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of 11 U.S.C. §101 et seq. (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 CSRO 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 proceeding by or
against CSRO under the Bankruptcy Code, ACORDA shall be entitled to all
applicable rights under Section 365 of the Bankruptcy Code, including but


 


18












 


not limited to, entitled to a complete duplicate of
(or complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property upon written request therefor by
ACORDA.


 


(b)                                 In
the event ACORDA is a debtor in a bankruptcy proceeding, whether voluntary or
involuntary, all rights and licenses granted pursuant to this Agreement are,
and shall otherwise be deemed to be, for purposes of Section 365 of the
Bankruptcy Code, executory contracts. 
The Parties agree that applicable law does not excuse CSRO from
accepting performance by, or rendering performance under this Agreement and all
rights and licenses granted hereunder to, a person or entity other than ACORDA.


 


9.4.                              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, its Affiliates and its 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.  In
addition to any other provisions of this Agreement which by their terms
continue after the expiration of this Agreement, the provisions 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 Articles VIII and X 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 accrued or accruing under this
Agreement prior to termination.  Except
as expressly set forth herein, the rights to terminate as set forth herein
shall be in addition to all other rights and remedies available under this
Agreement, at law, or in equity, or otherwise.


 


ARTICLE X


 


MISCELLANEOUS


 


10.1.                        Right to Develop
Independently.  Nothing in this
Agreement will impair ACORDA’s right to independently acquire, license,
develop, or have others develop for it, similar technology performing similar
functions to the Products or to market and distribute products based on other
technology.


 


10.2.                        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


 


19












 


(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.


 


10.3.                        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.


 


10.4.                        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.


 


10.5.                        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:


 


if to ACORDA to:


 


ACORDA THERAPEUTICS, INC.

16 Skyline Drive

Hawthorne, New York 10532

Attention: Ron Cohen

Fax No.: (914) 347-4560


 


if to CSRO to:


 


CANADIAN SPINAL RESEARCH ORGANIZATION

120 Newkirk Road, Unit 2

Richmond Hill, Ontario L4C 9S7

Attention: Barry Munro

Fax No.: (905) 508-4002


 


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


 


20












 


delivered and on the third Business Day following the
date of mailing if sent by registered or certified mail.


 


10.6.                        Applicable Law.  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.


 


10.7.                        Dispute Resolution.


 


(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)                                 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 New York, New York.  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.


 


(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 ACORDA and CSRO 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 New York, New York, USA.


 


21












 


(d)                                 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 10.6 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.


 


10.8.                        Entire Agreement.  This Agreement contains the entire understanding
of the Parties with respect to the subject matter hereof and supersedes all
previous writings and understandings, including without limitation, the 1995
Agreement. The Parties agree that the 1995 Agreement is hereby terminated, and
notwithstanding anything contained therein to the contrary,  is of no further force or effect.  This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by all Parties
hereto.


 


10.9.                        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.


 


10.10.                  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.


 


10.11.                  Further Assurances.  At any time or from time to time on and after
the Effective Date, CSRO 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


 


22












 


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.


 


10.12.                  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.


 


10.13.                  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.


 


10.14.                  Use of Names Except as
otherwise provided in this Agreement, neither Party shall 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 such other Party, which
consent shall not be unreasonably withheld or delayed; provided, however, that
either Party may use the name of the other Party in any document required to be
filed to obtain Regulatory Approval or to comply with applicable laws, rules or
regulations.


 


10.15.                  LIMITATION OF LIABILITY.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER
FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF
THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.


 


IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.


 


 


	
  CANADIAN SPINAL RESEARCH ORGANIZATION

  
	
   

  
	
  By:

  	
  /s/ Barry Munro

  	
   

  
	
   

  	
  Name:

  	
  Barry Munro

  
	
   

  	
  Title:

  	
  President

  
	
   

  
	
   

  
	
  ACORDA THERAPEUTICS, INC.

  
	
   

  
	
  By:

  	
  /s/ Harold Safferstein

  	
   

  
	
   

  	
  Name:

  	
  Harold Safferstein

  
	
   

  	
  Title:

  	
  VP of Business Development

  
				



 


23












 


EXHIBIT 1.2


 


ASSIGNMENTS


 


24












 


 


	
  FORM PTO-1595

  (Rev. 6/93)

  	
  U.S. DEPARTMENT OF
  COMMERCE

  Patent and Trademark Office

  
	
   

  	
  RECORDATION FORM COVER
  SHEET

  PATENTS ONLY

  	
  Attorney Docket No. 1094-1-002
  CIP

  
	
  To the Honorable
  Commissioner of Patents and Trademarks. Please record the attached original
  documents or copy threrof.

  
	
   

  
	
  1.     Name of conveying party(ies):

  

  Robert R. Hansebout and Andrew R. Blight

   

  Additional name(s) of
  conveying party(ies) attached? o  Yes    ý  No

  3.     Nature of conveyance:

  ý
  Assignment(s): 2                                  o
  Merger

  o Security Agreement   o
  Change of Name

  Other:_________________________________

  Execution
  Date:_____________________________

  	
  2.     Name and address of receiving party(ies):

  Name:     Canadian Spinal Research
  Organization

  Address: 120 Newkirk Road

     Unit 32
   Richmond Hill, Ontario, Canada  L4C 9S7

   

  Additional
  name(s) & address(es) attached? o  Yes    ý  No

  
	
  4.     Application number(s) or patent
  number(s):

  

  If this document is being filed together with a new application, the
  execution date of the application is: October 16, 1996 and October 20, 1996

  
	
  A. Patent Application
  No.(s)

  	
  B. Patent No. (s)

  
	
   

  	
   

  
	
  Additional numbers
  attached?   o  Yes    ý  No

  
	
  5.     Name and address of party to whom
  correspondence

  concerning document should be mailed:

  

  Name:     Barbara L. Renda Esq.

  Address: KLAUBER & JACKSON

  411 Hackensack Avenue, 4th Floor

  Hackensack, New Jersey 07601

  	
  6.     Total number of applications and patents
  involved:

  7.     Total fee(37 CFR 3.41): $80.00

  ý              Enclosed

  ý              Authorized to be charged to
  deposit account, if necessary for averages or underpayments only

  8.     Deposit account number:

  11-1153

  (Attach duplicate copy of this page if paying by deposit account)

   

  
	
  DO NOT USE THIS SPACE

  
	
  9.     Statement
  and signature.

  To the
  best of my knowledge and belief, the foregoing information is true and
  correct and any attached copy is a true copy of the original document.

   

  
	
  Barbara L. Renda, Esq.

  Name of Person Signing

  	
  /s/ Barbara L. Renda, Esq.

  	
   

  	
  11/1/96

  
	
  Signature

  	
   

  	
  Date:

  
	
   

  	
  Total number of pages including cover sheet,
  attachments, and document: 5

  
							



Mail documents to be
recorded with required cover sheet information to:


 


Assistant Commissioner
For Patents


Box Assignments


Washington, D.C, 20231


 

















 


ASSIGNMENT


 


WHEREAS, WE


 


ROBERT R. HANSEBOUT, a citizen of Canada, residing at 589 Scenic Drive,
Hamilton, Ontario L9C 1H1; and


 


ANDREW R. BLIGHT, a citizen of Great Britain, residing at 3228 Gait
Way, Chapel Hill, North Carolina 27516-7606


 


have
invented certain new and useful improvements in


 


THE USE OF 4-AMINOPYKIDINE IN THE
TREATMENT OF A NEUROLOGICAL  CONDITION


 


for
which we have executed an Application for Letters Patent in the United States
on even date herewith


 


WHEREAS,
                             
CANADIAN SPINAL RESEARCH ORGANIZATION,


with offices at 120 Newkirk Road, Unit 32, Richmond
Hill, Ontario,


L4C 9S7 Canada


 


is
desirous of obtaining the entire right, title and interest in, to and under the
said improvements and the said application;


 


NOW,
THEREFORE, FOR other good and valuable consideration, the receipt of which is
hereby acknowledged, we the said


 


ROBERT R. HANSEBOUT and ANDREW R. BLIGHT


 


have
sold, assigned, transferred and set over, and by these presents do hereby sell,
assign, transfer and set over, to the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, the entire right, title and
interest in, to and under the said improvements, and the said application and
all divisions, renewals and continuations thereof, and all Letters Patent of
the United States which may be granted thereon and all reissues and extensions
thereof, and all applications for Letters Patent which may hereafter be filed
for said improvements in any country or countries foreign to the United States,
including the right to claim priority under the terms of any appropriate
International Convention based upon said application for Letters Patent of the
United States, and all Letters Patent which may be granted for said
improvements in any country or countries foreign to the United States and
extensions, renewals and reissues thereof; and we hereby authorize and request
the Commissioner of Patents and Trademarks of the United States and any
official of any country or countries foreign to the United States, whose duty
it is to issue patents on applications as aforesaid, to issue all Letters
Patent for said improvements to the said


 

















 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, in accordance with the terms of
this instrument.


 


AND
WE HEREBY covenant that we have full right to convey the interest herein
assigned in the manner hereinabove set forth, and that we have not executed,
and will not execute, any agreement in conflict herewith.


 


AND WE HEREBY further covenant and agree that we will communicate to
the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, any fact known to us respecting
said improvements, and testify in any legal proceeding, sign all lawful papers,
execute all divisions, continuing and reissue applications, make all rightful
oaths and generally do everything possible to aid the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, to obtain and enforce proper
Patent Protection for said improvements in the United States.


 


IN
TESTIMONY WHEREOF, we hereunto set our hand and seal the day and year set
opposite our signatures.


 


 


	
  Date

  	
   

  	
  , 19

  	
  /s/ Robert R. Hansebout

  	
  L.S.

  
	
   

  	
  ROBERT R. HANSEBOUT

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date

  	
    October 20

  	
  , 1996

  	
    /s/ Andrew R. Blight

  	
  L.S.

  
	
   

  	
  ANDREW R. BLIGHT

  	
   

  
						



 


2

















 


ASSIGNMENT


 


WHEREAS,
WE


 


ROBERT R. HANSEBOUT, a citizen of Canada, residing
at 589 Scenic Drive, Hamilton, Ontario L9C 1H1; and


 


ANDREW R. BLIGHT, a citizen of Great Britain,
residing at 3228 Gait Way, Chapel Hill, North Carolina 27516-7606


 


have invented certain new and useful improvements in


 


THE USE OF 4-AMINOPYRIDINE IN THE
TREATMENT OF A NEUROLOGICAL  CONDITION


 


 


for
which we have executed an Application for Letters Patent in the United States
on even date herewith


 


WHEREAS,                        
CANADIAN SPINAL RESEARCH ORGANIZATION,


with offices at 120 Newkirk Road, Unit 32,
Richmond Hill, Ontario,


L4C 9S7 Canada


 


is
desirous of obtaining the entire right, title and interest in, to and under the
said improvements and the said application;


 


NOW,
THEREFORE, FOR other good and valuable consideration, the receipt of which is
hereby acknowledged, we the said


 


ROBERT R. HANSEBOUT and ANDREW R. BLIGHT


 


have
sold, assigned, transferred and set over, and by these presents do hereby sell,
assign, transfer and set over, to the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, the entire right, title and
interest in, to and under the said improvements, and the said application and
all divisions, renewals and continuations thereof, and all Letters Patent of
the United States which may be granted thereon and all reissues and extensions
thereof, and all applications for Letters Patent which may hereafter be filed
for said improvements in any country or countries foreign to the United States,
including the right to claim priority under the terms of any appropriate
International Convention based upon said application for Letters Patent of the
United States, and all Letters Patent which may be granted for said
improvements in any country or countries foreign to the United States and
extensions, renewals and reissues thereof; and we hereby authorize and request
the Commissioner of Patents and Trademarks of the United States and any
official of any country or countries foreign to the United States, whose duty
it is to issue patents on applications as aforesaid, to issue all Letters
Patent for said improvements to the said


 

















 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, in accordance with the terms of
this instrument.


 


AND
WE HEREBY covenant that we have full right to convey the interest herein
assigned in the manner hereinabove set forth, and that we have not executed,
and will not execute, any agreement in conflict herewith.


 


AND
WE HEREBY further covenant and agree that we will communicate to the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, any fact known to us respecting
said improvements, and testify in any legal proceeding, sign all lawful papers,
execute all divisions, continuing and reissue applications, make all rightful
oaths and generally do everything possible to aid the said


 


CANADIAN SPINAL RESEARCH ORGANIZATION


 


its
successors, legal representatives and assigns, to obtain and enforce proper
Patent Protection for said improvements in the United States.


 


IN
TESTIMONY WHEREOF, we hereunto set our hand and seal the day and year set
opposite our signatures.


 


 


	
  Date

  	
   

  	
  , 19

  	
   

  	
  L.S.

  
	
   

  	
  ROBERT R. HANSEBOUT

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date

  	
    OCT 20

  	
  , 1996

  	
  /s/ Andrew R. Blight

  	
  L.S.

  
	
   

  	
  ANDREW R. BLIGHT

  	
   

  



 


2

















 


DECLARATION
AND POWER OF ATTORNEY FOR PATENT 
APPLICATION


 


As below named inventors, we hereby declare
that:


 


Our residence, post office address and citizenship are as stated below
under our name.


 


We believe that we are the original, first and sole inventors (if only
one name is listed below) or an original, first and joint inventor (if plural
names are listed below) of the subject matter which is claimed and for which a
patent is sought on the invention entitled


 


THE USE OF 4-AMINOPYRIDINE IN THE
TREATMENT OF A NEUROLOGICAL CONDITION


 


the Specification of which


 


	
   

  	
  ý

  	
  is attached hereto

  	
   

  
	
   

  	
  o

  	
  was filed on
                                                        

  
	
   

  	
   

  	
  as Application Serial No.
                                   

  
	
   

  	
   

  	
  and was amended on
                                          

  	
  (if applicable).

  



 


We hereby state that we have reviewed and understand the contents of
the above-identified Specification, including the claims, as amended by any
amendment referred to above.


 


We acknowledge the duty to disclose information which is material to
the examination of this application in accordance with Title 37, Code of
Federal Regulations, 1.56(a).


 


We hereby claim foreign priority benefits under Title 35, United States
Code, §119 of any foreign application(s) for patent or inventor’s certificate
listed below and have also identified below any foreign application for patent
or inventor’s certificate having a filing date before that of the application
on which priority is claimed.


 


	
  APPLICATION

  	
   

  	
  PRIOR FILED APPLICATIONS(S)

  	
   

  	
  PRIORITY

  	
   

  
	
  NUMBER

  	
   

  	
  COUNTRY

  	
   

  	
  (DAY/MONTH/YEAR FILED)

  	
   

  	
  CLAIMED

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NONE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


We hereby claim the benefit under Title 35, United States Code, §120 of
any United States application listed below, and, insofar as the subject matter
of each of the claims of this application is not disclosed in any prior United
States application in the manner provided by the first paragraph of Title 35,
United States Code, §112, we acknowledge the duty to disclose material
information as defined in Title 37, Code of Federal Regulations, §1.56(a), which
occurred between the filing date of the prior application and the national or
PCT international filing date of this application;


 

















 


	
  APPLICATION

  	
   

  	
  FILING DATE

  	
   

  	
  STATUS - PATENTED, PENDING,

  	
   

  
	
  NO.

  	
   

  	
  (DAY/MONTH/YEAR)

  	
   

  	
  ABANDONED

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  08/290,757

  	
   

  	
  September 13, 1994

  	
   

  	
  PENDING

  	
   

  



 


We
hereby appoint as our attorneys or agents the following persons; Jack Matalon,
(Attorney, Registration No. 22,441); Stefan J, Klauber, (Attorney,
Registration No. 22,604); David A. Jackson (Attorney, Registration No. 26,742);
Raymond M. Speer (Attorney, Registration No. 26,810); Barbara L. Renda
(Attorney, Registration No. 27,626); Paul F. Fehlner (Attorney,
Registration No. 35,135); Joseph M. Homa, (Attorney, Registration No. 40,023)
and Michael D. Davis, (Attorney, Registration No. 39,161) said attorneys
or agents to have full power of substitution and revocation to prosecute this
application and transact all business in the Patent and Trademark Office
connected therewith.


 


Please
address all correspondence regarding this application to:


 


DAVID A. JACKSON, ESQ.


KLAUBER & JACKSON


411 HACKENSACK AVENUE


HACKENSACK, NEW JERSEY 07601


 


Direct
all telephone calls to David A. Jackson at (201) 487-5800.


 


I
hereby declare that all statements made herein of my own knowledge are true and
that all statements made on information and belief are believed to be true; and
further, that these statements were made with the knowledge that willful false
statements and the like so made are punishable by fine or imprisonment, or
both, under Section 1001 of Title 18 of the United States Code and that
such willful false statements may jeopardize the validity of the application or
any patent issued thereon.


 


 


	
  FULL
  NAME OF FIRST INVENTOR:

  	
   ROBERT
  R. HANSEBOUT

  	
   

  
	
  RESIDENCE:

  	
   

  	
  Hamilton,
  Ontario

  
	
  COUNTRY
  OF CITIZENSHIP:

  	
   

  	
  Canada

  
	
  POST
  OFFICE ADDRESS:

  	
   

  	
  589
  Scenic Drive

  
	
   

  	
   

  	
  Hamilton,
  Ontario L9C 1H1

  
	
   

  
	
  SIGNATURE
  OF INVENTOR

  	
   

  	
   

  
	
   

  
	
  DATE

  	
   

  	
   

  
								



 


2

















 


	
  FULL NAME OF SECOND JOINT INVENTOR:

  	
  ANDREW R. BLIGHT

  
	
  RESIDENCE:

  	
   

  	
  Chapel Hill, North Carolina

  
	
  COUNTRY OF CITIZENSHIP:

  	
   

  	
  Great Britain

  
	
  POST OFFICE ADDRESS:

  	
   

  	
  3228 Gait Way

  
	
   

  	
   

  	
  Chapel Hill, North Carolina 27516-7606

  
	
   

  
	
   

  
	
  SIGNATURE OF INVENTOR

  	
    /s/ Andrew R. Blight

  	
   

  
	
   

  
	
  DATE

  	
    Oct 20, 1996

  	
   

  
							



 


3

















 


DECLARATION
AND
POWER
OF ATTORNEY FOR PATENT APPLICATION


 


As
below named inventors, we hereby declare that:


 


Our
residence, post office address and citizenship are as stated below under our
name.


 


We
believe that we are the original, first and sole inventors (if only one name is
listed below) or an original, first and joint inventor (if plural names are
listed below) of the subject matter which is claimed and for which a patent is
sought on the invention entitled


 


THE USE OF
4-AMINOPYRIDINE IN THE TREATMENT OF A


NEUROLOGICAL
CONDITION


 


the
Specification of which


 


	
   

  	
  ý

  	
  is attached hereto

  	
   

  
	
   

  	
  o

  	
  was filed on
                                                        

  
	
   

  	
   

  	
  as Application Serial No.
                                   

  
	
   

  	
   

  	
  and was amended on
                                          

  	
  (if applicable).

  



 


We
hereby state that we have reviewed and understand the contents of the
above-identified Specification, including the claims, as amended by. any
amendment referred to  above.


 


We
acknowledge the duty to disclose information which is material to the
examination of this application in accordance with Title 37, Code of Federal
Regulations, 1.56(a).


 


We
hereby claim foreign priority benefits under Title 35, United States Code, §119
of any foreign application(s) for patent or inventor’s certificate listed below
and have also identified below any foreign application for patent or inventor’s
certificate having a filing date before that of the application on which
priority is claimed.


 


	
  APPLICATION

  	
   

  	
  PRIOR FILED APPLICATIONS(S)

  	
   

  	
  PRIORITY

  	
   

  
	
  NUMBER

  	
   

  	
  COUNTRY

  	
   

  	
  (DAY/MONTH/YEAR FILED)

  	
   

  	
  CLAIMED

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NONE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


We
hereby claim the benefit under Title 35, United States Code, §120 of any United
States application listed below, and, insofar as the subject matter of each of
the claims of this application is not disclosed in any prior United States
application in the manner provided by the first paragraph of Title 35, United
States Code, §112, we acknowledge the duty to disclose material information as
defined in Title 37, Code of Federal Regulations, §1.56(a), which occurred
between the filing date of the prior application and the national or PCT
international filing date of this application:


 

















 


	
  APPLICATION

  	
   

  	
  FILING DATE

  	
   

  	
  STATUS - PATENTED, PENDING,

  	
   

  
	
  NO.

  	
   

  	
  (DAY/MONTH/YEAR)

  	
   

  	
  ABANDONED

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  08/290,757

  	
   

  	
  September 13, 1994

  	
   

  	
  PENDING

  	
   

  



 


We hereby appoint as our attorneys or agents the
following persons:  Jack Matalon,
(Attorney, Registration No. 22,441); Stefan J. Klauber, (Attorney,
Registration No. 22,604); David A. Jackson (Attorney, Registration No. 26,742);
Raymond M. Speer (Attorney, Registration No. 26,810); Barbara L. Renda
(Attorney, Registration No. 27,626); Paul F. Fehlner (Attorney,
Registration No. 35,135); Joseph M. Homa, (Attorney, Registration No,
40,023) and Michael D. Davis, (Attorney, Registration No. 39,161) said
attorneys or agents to have full power of substitution and revocation to
prosecute this application and transact all business in the Patent and
Trademark Office connected therewith.


 


Please address all correspondence regarding this
application to:


 


DAVID A. JACKSON, ESQ.


KLAUBER &
JACKSON


411 HACKENSACK AVENUE


HACKENSACK, NEW JERSEY
07601


 


Direct all telephone calls to David A. Jackson at
(201) 487-5800.


 


I hereby declare that all statements made herein of my
own knowledge are true and that all statements made on information and belief
are believed to be true; and further, that these statements were made with the
knowledge that willful false statements and the like so made are punishable by
fine or imprisonment, or both, under Section 1001 of Title 18 of the
United States Code and that such willful false statements may jeopardize the
validity of the application or any patent issued thereon,


 


 


	
  FULL NAME OF FIRST
  INVENTOR:

  	
  ROBERT R. HANSEBOUT

  
	
  RESIDENCE:

  	
  Hamilton, Ontario

  
	
  COUNTRY OF CITIZENSHIP:

  	
  Canada

  
	
  POST OFFICE ADDRESS:

  	
  589 Scenic Drive

  
	
   

  	
  Hamilton, Ontario L9C 1HI

  
	
   

  
	
   

  
	
  SIGNATURE OF INVENTOR

  	
    /s/ R. Hansebout

  	
   

  
	
   

  
	
  DATE

  	
    Oct. 16,
  1996

  	
   

  
							



 


2

















 


	
  FULL NAME OF SECOND JOINT INVENTOR:

  	
  ANDREW R. BLIGHT

  	
   

  
	
  RESIDENCE:

  	
   

  	
  Chapel Hill, North Carolina

  
	
  COUNTRY OF CITIZENSHIP:

  	
   

  	
  Great Britain

  
	
  POST OFFICE ADDRESS:

  	
   

  	
  3228 Gait Way

  
	
   

  	
   

  	
  Chapel Hill, North Carolina 27516-7606

  
	
   

  
	
   

  
	
  SIGNATURE OF INVENTOR

  	
   

  	
   

  
	
   

  
	
  DATE

  	
   

  	
   

  
								



 


3

















 


SCHEDULE 1.6


 


DIAGRAM OF 4-AP


 


4-aminopyridine
(“4-AP”), C5H6N2, MW 94


 


 





 


25












 


SCHEDULE
1.16 

PATENT ASSETS


Case Number:                         A01


 


	
  Title:

  	
  USE OF 4-AMINOPYRIDINE
  IN THE REDUCTION OF CHRONIC 

  PAIN AND SPASTICITY IN A SPINAL CORD INJURED PATIENT

  	
  Inventor(s):

  
	
   

  	
  Hansebout, Robert R.

  Blight, Andrew R

  
	
  Client:

  	
  Acorda Therapeutics
  Inc.

  	
   

  
	
  Owner:

  	
  Canadian Spinal
  Research Organization

  	
   

  
	
  Disclosure
  Status:

  	
  Filed

  	
   

  
	
  Disclosure
  Date:

  	
   

  	
   

  
	
  Attorney(s):

  	
  MF

  	
   

  



 


	
  Country

  	
   

  	
  Sub Case

  	
   

  	
  Case Type

  	
   

  	
  Status

  	
   

  	
  Application Number

  	
   

  	
  Filing Date

  	
   

  	
  Patent Number

  	
   

  	
  Issue Date

  	
   

  	
  Expiration Date

  	
   

  
	
  Australia

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  56911/94

  	
   

  	
  20-Dec-1993

  	
   

  	
  676251

  	
   

  	
  06-Mar-1997

  	
   

  	
  18-Dec-2012

  	
   

  
	
  Austria

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  1993094902578

  	
   

  	
  20-Dec-1993

  	
   

  	
  0241981

  	
   

  	
  15-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Bulgaria

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  99047

  	
   

  	
  20-Dec-1993

  	
   

  	
  62272

  	
   

  	
  12-Nov-1998

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Canada

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Pending

  	
   

  	
  2085785

  	
   

  	
  20-Dec-1993

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  18-Dec-2012

  	
   

  
	
  Czech Republic

  	
   

  	
   

  	
   

  	
  ORD

  	
   

  	
  Granted

  	
   

  	
  PV2254-94

  	
   

  	
  20-Dec-1993

  	
   

  	
  284441

  	
   

  	
  11-Nov-1998

  	
   

  	
  20-Dec-2013

  	
   

  
	
  European Patent Convention

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  France

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Germany, Federal Republic
  of

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  69333014

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Hungary

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  P94-02647

  	
   

  	
  20-Dec-1993

  	
   

  	
  219583

  	
   

  	
  02-Aug-2001

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Ireland

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Italy

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Japan

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  6-514637

  	
   

  	
  20-Dec-1993

  	
   

  	
  8504772

  	
   

  	
  21-May-1996

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Korea, Democratic People’s
  Republic of

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  P-94-354

  	
   

  	
  20-Dec-1993

  	
   

  	
  31250

  	
   

  	
  30-Aug-1997

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Korea, Republic of

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  94-702838

  	
   

  	
  20-Dec-1993

  	
   

  	
  10-301415

  	
   

  	
  25-Jun-2001

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Liechtenstein

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Netherlands

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  New Zealand

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  258844

  	
   

  	
  20-Dec-1993

  	
   

  	
  258844

  	
   

  	
  09-Oct-2000

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Norway

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
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  1994 3049

  	
   

  	
  20-Dec-1993

  	
   

  	
  308.644

  	
   

  	
  09-Oct-2000

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Russian Federation

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
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  94041207.00

  	
   

  	
  20-Dec-1993

  	
   

  	
  2160590

  	
   

  	
  20-Oct-2000

  	
   

  	
  20-Dec-2013

  	
   

  
	
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  9705418-3

  	
   

  	
  19-Apr-1996

  	
   

  	
  48615

  	
   

  	
  20-Jul-1999

  	
   

  	
  19-Apr-2016

  	
   

  
	
  Slovakia

  	
   

  	
   

  	
   

  	
  PCT

  	
   

  	
  Granted

  	
   

  	
  PV-0969-94

  	
   

  	
  20-Dec-1993

  	
   

  	
  280922

  	
   

  	
  24-May-2000

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Spain

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  Sweden

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  United Kingdom

  	
   

  	
   

  	
   

  	
  EPC

  	
   

  	
  Granted

  	
   

  	
  94902578.7

  	
   

  	
  20-Dec-1993

  	
   

  	
  0626848

  	
   

  	
  04-Jun-2003

  	
   

  	
  20-Dec-2013

  	
   

  
	
  United States of America

  	
   

  	
   

  	
   

  	
  ORD

  	
   

  	
  Granted

  	
   

  	
  08/290757

  	
   

  	
  13-Sep-1994

  	
   

  	
  5545648

  	
   

  	
  13-Aug-1996

  	
   

  	
  13-Sep-2014

  	
   

  



 


Abstract:  A
method of reducing chronic pain and spasticity in a spinal cord injured patient
in need of such treatment comprising administering an effective amount of
4-aminopyridine to said patient.


 


26












 


EXHIBIT 1.2


 


ASSIGNMENTS


 


24

















 


EXHIBIT 6.1(o)


 


INTER-INSTITUTIONAL AGREEMENT


 


INTER-INSTITUTIONAL
AGREEMENT


 


THIS AGREEMENT made the
18th day of October,1993, is by and between PURDUE RESEARCH FOUNDATION
(hereinafter “PRF”), McMASTER UNIVERSITY (hereinafter “McMaster”) and the
CANADIAN SPINAL RESEARCH ORGANIZATION, a not-for-profit organization (here in
after “CSRO”)


 


WHEREAS, Dr. Blight
and Dr. Hansebout have jointly invented technology relating to the utility of
the chemical  compound 4-aminopyridine in
the therapy of human patients with spinal cord injury as described in
attachment 1 of this agreement (hereinafter “the Technology”).


 


WHEREAS at the time of
inventing the Technology, Dr. Blight was employed by Purdues University
and is under an obligation to transfer all his rights in the technology to PRF,
and Dr. Hansebout was employed by McMaster and is under an obligation to
transfer all his rights in the Technology to McMaster.


 


WHEREAS CSRO provided
funding for the research resulting in invention of the Technology and agree to
be responsible for filing patent applications on the technology.


 


WHEREAS Dr. Blight
and Dr. Hansebout, PRF, and McMaster desire to license the Technology to
benefit the public, to provide support to CSRO for further spinal cord
research, and to cover the cost of filing, prosecuting and maintaining patent
applications on the Technology.


 


NOW, THEREFORE, in
consideration of the premises and mutual covenants contained herein, the
parties hereto agree as follows,


 


1.                                                                    DEFINITION:
“Patent Rights”, as used herein shall mean “rights in and to any patent
applications, in any jurisdiction


 

















 


and any all divisions,
continuations, continuations in part, reissues, re-examinations or extensions
thereof, and any letters patent that issue thereon they make claims relating to
all or part of the Technology.


 


2.                                                                    CSRO,
at its own expense and using counsel of its choice, may file, prosecute, and
maintain applications and patents on the patent rights. Applications may be
filed in Canada, the United States of America and countries foreign thereon.
CSRO shall solicit PRF’s and McMaster’s input on all patent matters relating to
the Patent Rights including providing PRF and McMaster with copies of all
applications and response to Examiner’s action before transmittal and providing
PRF and McMaster with copies of all examiner’s actions and other patent related
correspondence in a timely fashion after receipt. In the event that CSRO elects
not to file patent applications in Canada or the United States or to abandon
applications filed in any country, CSRO shall provide written notice to PRF and
McMaster of its decision at least forty-five (45) days prior to any
patentability bar date or due date. If PRF or McMaster desire to file, continue
prosecution or maintain such application(s) or letters patent(s), any rights of
CSRO under this agreement relating to the aspect of the Technology claimed in
said application(s) or letter patent(s) shall cases. If PRF and/or McMaster are
interested in continuing with the patenting process with respect to said
application(s) or letters patent(s), they shall negotiate a separate agreement
in good faith.


 


3.                                                                    The
parties agree that CSRO shall have the sole authority to license any Patent
Rights under this agreement, CSRO may, in good faith and in its sole
discretion, negotiate a suitable licensing agreement including, without
limiting the generality of the foregoing a royalty bearing, exclusive,
World-Wide license to the Patent Rights, and has the authority to include
provision in any such license agreement for the licensee


 


2

















 


to pay the expense of,
and have control with respect to, filing, prosecuting, and maintaining patent
application(s) and letters patent(s) on the patent rights subject to the rights
of PRF and McMaster to be kept informed and have an opportunity to give input
on all patent better and to file, continue prosecution and maintenance of such
application(s) or letters patent(s) as their own expense should CSRO and the
licenses elect not to file, continue to prosecute, or maintain said
application(s) or letters patent(s).  The
right to negotiate a licensing agreement extends to any entity that controls,
is controlled by or under common control with CSRO.


 


4.                                                                    CSRO
shall commit itself to using good faith efforts to develop the Technology into
commercial products.  Such good faith efforts
shall include taking positive steps to attempt to license the Technology for
commercial exploitation thereof.


 


5.                                                                    “Gross
Income” with respect to the Technology or any patent or patent application
covering all or part of the Technology shall be deemed to consist of money
actually received by CSRO through the licensing of the Technology to others
less any reasonable future expenses incurred in administering licenses for the
technology, “Divisible Income” shall be deemed to consist of simulative Gross
Income in excess of $25,000 cdn., (an amount agreed by the parties to repay a
portion of CSRO’s costs in filing, prosecuting and maintaining application(s)
and letters patent(s) licensing costs, and the cost of past and future research
with respect to the Technology.  CSRO
shall pay over to each of PRF and McMaster, an amount equal to twenty-five
percent (25%) of divisible Income payable as Divisible Income is received, but
not more often than quarterly.


 


6.                                                                    PRF
and McMaster shall be responsible, and solely shall be responsible, for paying
to their respective inventors such share of the royalties attributable to the
inventions of the


 


3

















 


inventors as is customary
under their rules and practices, except as provided for in paragraph 7
below.


 


7.                                                               The
term of this agreement shall extend for so long as any letters patent covered
by the agreement remain unexpired or any patent application covered by the
agreement remains pending in any Patent Office. However, any party may elect to
withdraw from the agreement and forego any benefits extending to it under the
agreement, in which case, so long as CSRO is not the withdrawing party, CSRO
shall have the sale right to any income thereafter received from any licenses
with respect to Patent Rights. With respect to income which would otherwise
have been due to the withdrawing party, CSRO shall pay to the inventor
associated with that party such share of the royalties attributable to the
inventions of the inventor as is customary under the rules or practices of
the withdrawing party. If CSRO elects to withdraw from the agreement, income
which would otherwise go to CSRO shall be equally divided between PRF and
McMaster.


 


8.                                                               PRF
and McMaster make no representations and extend no warranties of any kind,
either expressed or implied, including, but not limited to, warranties of merchantability,
fitness for a particular purpose, and validity of Patent Rights claims, issued
or pending.


 


9.                                                               Except
for assignment to an affiliated organization, rights under this agreement shall
not be assignable, and any attempt to do so shall be void.


 


10.                                                         PRF
and McMaster agree to cooperate with CSRO in all reasonable ways with respect
to obtaining patents on the Technology, licensing the technology and enforcing
rights therein. These obligations shall extend to include obtaining inventors
signatures on relevant documents, inventor review of 


 


4

















 


the application, Office
actions, and the like, providing signatures by appropriate signing authorities
necessary to enter into a reasonable licensing agreement and being added as a
party to an action; in the courts in the event that it is necessary to litigate
on the patent. 


 


IN WITNESS WHEREOF, the
parties who have caused this agreement to be executed in duplicate by their
duly authorized representatives.


 


	
  MCMASTER UNIVERSITY

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Mark R. McDermott

  	
   

  	
  Oct. 21/93

  	
   

  
	
  Mark R. McDermott

  	
   

  	
  Date: 

  	
   

  
	
  Director, Officer of
  Research

  Contracts and Intellectual

  Property

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  PURDUE RESEARCH
  FOUNDATION

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Robert R. Greenkorn

  	
   

  	
  NOV 8 1983

  	
   

  
	
  ROBERT R. GREENKORN

  	
   

  	
  Date:

  	
   

  
	
  Vice President for
  Programs

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  CANADIAN
  SPINAL RESEARCH

  ORGANIZATION

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Ray Wickson

  	
   

  	
  October 21, 1993

  	
   

  
	
  Ray Wickson

  	
   

  	
  Date: 

  	
   

  
	
  President 

  	
   

  	
   

  	
   

  



 


5