Exhibit 10.8


 


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.


 


EXECUTION COPY


 


Date:     September 2003


 


 


ELAN CORPORATION, PLC.


 


AND


 


ACORDA THERAPEUTICS, INC.


 


 


AMENDED AND RESTATED LICENSE
AGREEMENT


 

















 


INDEX


 


	
  ARTICLE 1

  	
  DEFINITIONS AND INTERPRETATION

  
	
   

  	
   

  
	
  ARTICLE 2

  	
  THE LICENSE

  
	
   

  	
   

  
	
  ARTICLE 3

  	
  DEVELOPMENT OF THE PRODUCT

  
	
   

  	
   

  
	
  ARTICLE 4

  	
  [NOT USED]

  
	
   

  	
   

  
	
  ARTICLE 5

  	
  FINANCIAL PROVISIONS

  
	
   

  	
   

  
	
  ARTICLE 6

  	
  REGISTRATION OF THE PRODUCT

  
	
   

  	
   

  
	
  ARTICLE 7

  	
  [NOT USED]

  
	
   

  	
   

  
	
  ARTICLE 8

  	
  WARRANTY AND INDEMNITY

  
	
   

  	
   

  
	
  ARTICLE 9

  	
  [NOT USED]

  
	
   

  	
   

  
	
  ARTICLE 10

  	
  COMMITTEE

  
	
   

  	
   

  
	
  ARTICLE 11

  	
  PATENTS

  
	
   

  	
   

  
	
  ARTICLE 12

  	
  SUNDRY CLAUSES

  
	
   

  	
   

  
	
  SCHEDULE 1

  	
  ACORDA
  PATENT RIGHTS

  
	
   

  	
   

  
	
  SCHEDULE 2

  	
  ASSIGNMENT
  AGREEMENT

  
	
   

  	
   

  
	
  SCHEDULE 3

  	
  ELAN PATENT
  RIGHTS

  
	
   

  	
   

  
	
  SCHEDULE 4

  	
  NDA TIMELINE

  
	
   

  	
   

  
	
  SCHEDULE 5

  	
  RUSH/ACORDA
  LICENSE

  
	
   

  	
   

  
	
  SCHEDULE 6

  	
  RUSH
  PAYMENTS AGREEMENT

  
	
   

  	
   

  
	
  SCHEDULE 7

  	
  SPECIFICATIONS

  
	
   

  	
   

  
	
  SCHEDULE 8

  	
  SUPPLY
  AGREEMENT

  
	
   

  	
   

  
	
  SCHEDULE 9

  	
  TECHNOLOGY
  TRANSFER RESPONSIBILITES

  



 

















 


THIS
AMENDED AND RESTATED LICENSE AGREEMENT is made as of
the          day of
September 2003


 


BETWEEN:


 


(1)                                 Elan Corporation, plc., a
public limited company incorporated under the laws of Ireland, and having its
registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“Elan”); and


 


(2)                                 Acorda Therapeutics, Inc., a corporation organized under the laws of the
State of Delaware and having its principal office at 15 Skyline Drive,
Hawthorne, New York 10532,
United States of America (“Acorda”).


 


RECITALS:


 


(A)                              As of April 21,
1998, Elan and Acorda entered into an amended and restated licence and supply
agreement relating to SCI (effective as from January 23, 1997) (the “SCI Agreement”);


 


(B)                                Effective as of
April 21, 1998, Elan, Acorda and MS R & D entered into a licence and
supply agreement relating to MS (the “MS
Agreement”);


 


(C)                                Pursuant to the
Assignment Agreement (i) MS R & D assigned all of its rights, title,
interest and obligations under the MS Agreement to Acorda, and Acorda assumed
all of MS R & D’s obligations thereunder; and (ii) Elan, Acorda and MS R
& D terminated the MS R & D Agreements (as defined in the Assignment
Agreement)


 


(D)                               The Parties desire
and agree that certain provisions of the SCI Agreement and the MS Agreement
should be amended, clarified and restated to reflect the intentions of the
Parties with respect to the development, manufacturing and marketing of the
Product in the Territory for the Indications on the terms and conditions set
out herein.


 


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 each of the MS Agreement and the SCI
Agreement, and all of the terms, conditions and provisions of the MS Agreement
and the SCI Agreement, are hereby superceded and replaced and restated in their
entirety by this Agreement and the Supply Agreement and the terms, conditions
and provisions hereof and thereof, as of the Amendment Date, as follows and as
set forth in the Supply Agreement:


 


ARTICLE 1   DEFINITIONS
AND INTERPRETATION


 


1.1.                                   In the
present Agreement and any further agreements based thereon between the Parties
hereto, the following definitions shall prevail:


 


1

















 


“Acorda Know-How” shall mean all knowledge,
information, trade secrets, data and expertise relating to the Product which is
not generally known to the public that is owned or possessed by Acorda (and/or
its Affiliates), or that is developed by Acorda (and/or its Affiliates) during
the term of this Agreement relating to the Product, including clinical data,
whether or not covered by any patent, copyright, design, trademark or other
industrial or intellectual property rights and excluding Elan Intellectual
Property. Title to all inventions and other intellectual property made solely
by Acorda employees in connection with the Project shall be owned by Acorda.


 


“Acorda Patent Rights” shall mean any and
all rights under any and all patents and patent applications now existing,
currently pending or hereafter filed, owned or acquired or licensed by Acorda
(and/or its Affiliates) from a Third Party which would be infringed by the
manufacture, use or sale of the Product, the current status of which is set
forth in Schedule 1.  Acorda
Patent Rights shall also include all continuations, continuations-in-part,
divisionals and re-issues of such patents and patent applications and any
patents issuing thereon and extensions of any patents licensed hereunder.  Acorda Patent Rights shall further include
any patents or patent applications covering any improved methods of making or
using the Product invented or acquired by Acorda (and/or its Affiliates) from a
Third Party during the term of this Agreement, and under which Acorda (and/or
its Affiliates) has a right to grant a licence hereunder. Acorda Patent Rights
shall exclude Elan Intellectual Property.


 


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


 


“Affiliate” shall mean any corporation or
entity controlling, controlled by or under the common control of Elan or Acorda
as the case may be.  For the purpose of
this Agreement, “control” shall mean the direct or indirect ownership of at
least fifty percent (50%) of the outstanding shares or other voting rights of
the subject entity to elect directors, or if not meeting the preceding
criteria, any entity owned or controlled by or owning or controlling at the
maximum control or ownership right permitted in the country where such entity
exists.


 


“Agreement” shall  mean this amended and restated license agreement (which
expression shall be deemed to include the Recitals and Appendices and Schedules
hereto).


 


“Alternate Compound” shall mean any mono- or
di-aminopyridine, other than the Compound, as well as the isomers, and the
salts thereof.


 


“Amendment Date” shall
mean      September 2003.


 


“API” shall mean any Compound or Alternate
Compound, in bulk form, for use as an active ingredient in the manufacture of
Product.


 


2

















 


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.


 


 


“Assignment Agreement” shall mean the
Termination and Assignment Agreement entered into by and among Acorda, Elan and
MS R & D as of the Amendment Date, a copy of which is attached hereto as Schedule 2.


 


“Cardinal Agreement” shall mean the
Laboratory Services Agreement by and between Cardinal Health PTS, Inc.
(“Cardinal”) and Acorda dated April 1, 2003 relating to stability testing
of oral tablets of Fampridine.


 


“cGCP”, “cGLP”
and “cGMP” shall mean current Good
Clinical Practises, current Good Laboratory Practises and current Good
Manufacturing Practises, respectively, pursuant to the Act and FDA guidance
documents.


 


“CMC Section” shall mean the chemistry,
manufacturing, and controls section of an NDA as defined in 21 CFR
Section 314.50 (1) and its equivalent in other registration applications.


 


“Committee” shall mean the committee to be
established pursuant to Article 10.


 


“Competition” shall mean on a country by country basis the sale
or distribution by a Third Party of a sustained release oral pharmaceutical
formulation of a mono- or di-aminopyridine active agent for administration on a
once or twice daily basis for the treatment or amelioration of any neurological
condition(s) (including neurogenic conditions) in humans, where the sales or distribution of such
formulation by said Third Party for a calendar year are at least [**] of the
total sales of the Product in such country in such calendar year expressed in
equivalent units.  The determination
that Competition exists in any country in any calendar year shall be deemed
conclusively if a mutually agreed reputable organization such as IMS  has made such determination based on its
conduct of a market share study in such country during such year, provided the
existence of such level of sales of competing products may also be established
by other reasonable evidence.  Once a
determination is made that Competition exists for a Product in any country,
such determination shall be made again by the Parties each calendar year for so
long as the Product is marketed in that country; provided that in the event
that Competition has ceased prior to the end of a calendar year and has not
resumed, the Competition shall be deemed to have terminated for such year.


 


“Compound” shall mean the compound known as
4-aminopyridine as well
as the isomers, and the salts thereof.


 


“Confidential Information” shall mean (i)
any proprietary or confidential information or material in tangible form
disclosed hereunder that is marked as “Confidential” at the time it is
delivered to the receiving Party, or (ii) proprietary or confidential
information disclosed orally hereunder which is identified as confidential or
proprietary when disclosed and such disclosure of confidential information is
confirmed in writing within thirty (30) days by the disclosing Party.


 


“Designee” shall mean a sub-licensee,
distributor or any other Third Party authorised by Acorda including those entities
or persons appointed by Acorda pursuant to the provisions of
Article 2.3.1.


 


3

















 


“Development Plan” shall have the
meaning set forth in Article 3.1.


 


“DMF” shall mean a Drug Master File, as
defined in 21 CFR Section 314.420, as the same may be amended or
re-promulgated from time to time, or any successor filing or procedure and/or
its equivalent in the other countries of the Territory.


 


“Dominating Patent” shall mean an unexpired
patent that has not been invalidated by a court or governmental agency which is
owned by a Third Party, which covers the Product sold by Acorda or its
Designees, under circumstances such that Acorda, including on behalf of its
Designees, has no commercially reasonable alternative to obtaining a
royalty-bearing licence under such patent in order to practise or exploit the
Elan Intellectual Property to develop and/or commercialise the Product.


 


“EDDI” shall mean Elan Drug Delivery Inc., a
wholly-owned subsidiary of Elan, and the successor to Elan Pharmaceutical
Research Corp.


 


“Elan Intellectual Property” shall mean the
Elan  Patent Rights and/or the Elan  Know-How.


 


“Elan Know-How” shall mean all knowledge,
information, trade secrets, data and expertise within Elan’s oral controlled release
technology relating to the Product which is not generally known to the public
that is owned or possessed by Elan (and/or its Affiliates), or to be developed
by Elan (and/or its Affiliates), whether before or during the term of this
Agreement, whether or not covered by any patent, copyright, design, trademark
or other industrial or intellectual property rights, or developed by or on
behalf of Elan (and/or its Affiliates) in connection with the Project, or
developed by or on behalf of Elan (and/or its Affiliates) pursuant to the
Axogen Agreement. Title to all inventions and other intellectual property made
solely by employees of Elan in connection with the Project shall be owned by
Elan.


 


Elan
Know-How shall exclude:


 


(a)                             any and all know how
as of the Amendment Date pertaining to the development or manufacture of
transdermal formulations of the Compound and/or other mono- or
di-aminopyridines, isomers and salts thereof, other than US patents numbers
5,370,879, 5,540,938 and/or 5,580,580, and any foreign equivalents,
divisionals, reissues or continuations and any patents issued thereon, and the
know-how described therein; and


 


(b)                            nanoformulation
technology to the extent specifically licensed by Elan to Merck pursuant to the
Merck Agreement for Indications other than MS or SCI.


 


“Elan Patent Rights” shall mean any and all
rights under any and all patents and patent applications now existing,
currently pending or hereafter filed, owned or acquired or licensed by Elan
(and/or its Affiliates) which would be infringed by the manufacture, use or
sale of the Product, the current status of which as of the Amendment Date is
set forth in Schedule 3.  Elan Patent Rights shall also include all
continuations, continuations-in-part, divisionals and re-issues of such patents
and patent applications and any patents


 


4

















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.


 


issuing
thereon and extensions of any patents licensed hereunder.  Elan Patent Rights shall further include any
patents or patent applications covering any improved methods of making or using
the Product invented or acquired by Elan (and/or its Affiliates) during the
term of this Agreement and under which Elan (and/or its Affiliates) has a right
to grant a licence hereunder, and Elan’s (and/or its Affiliates) interest in
any intellectual property conceived reduced to practice or otherwise developed
in connection with the Project.


 


“EMEA” shall mean the European Agency for
the Evaluation of Medicinal Products based in London (UK), as established by
Council Regulation n° 2309/93 of July 22, 1993, as subsequently amended by
Commission Regulation 649/98 of March 23, 1998.


 


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


 


“EXW” and “Ex
Works” shall have the meaning as such term is defined in the ICC
Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC
Publication No. 560.


 


“Fampridine Product” shall mean any finished
pharmaceutical oral sustained release dosage form containing the Compound,
which is in the scope of one or more Valid Claims within the Elan  Patent Rights in the country of sale,
and/or incorporates Elan  Know-How
in material part.  The use of the
pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods,
clinical protocols and data developed for and on behalf of Elan, which is
included in the Elan Know-How shall constitute incorporation of the Elan  Know-How in material part.


 


“FDA” shall mean the United States Food and
Drug Administration or any other successor agency, whose approval is necessary
to market the Product in the United States of America.


 


“First Commercial Sale” shall mean the first
In Market sale of Product in any country by Acorda or an Acorda Designee for
end use or consumption, after all required Regulatory Approvals have been
granted by the governing health authority of such country.


 


“FTE” means Elan’s full time equivalent
charging rate for its appropriate employees or consultants from time to time
(based on cost without mark-up) which as of the Amendment Date is US[***] per
day.


 


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


 


“IND” shall mean the investigational new
drug application and any amendments thereto for the Product filed with the FDA
including IND numbers [*****].


 


5

















 


 “Indication”
shall mean any use or indication of Product for treatment of any condition,
including SCI and MS.


 


“Initial Period” shall have the meaning set
forth in Article 12.5.1.1.


 


“In Market” shall mean the sale of the
Product, whether by Acorda or its Designee, to an unaffiliated Third Party such
as a wholesaler, distributor, managed care organisation, hospital or pharmacy
and shall exclude the transfer pricing of the Product by Acorda to an
Affiliate.


 


“Joint Invention” shall mean all
inventions and other intellectual property made jointly by employees of Acorda
and Elan in connection with the Project, which inventions and intellectual
property shall be jointly owned by Elan and Acorda.


 


“Launch Stocks” shall have the meaning set
forth in the Supply Agreement.


 


“License Revenues” shall mean the monetary
amount or non cash consideration (exclusive of any taxes or duties that Acorda
may be required by law to pay, but not including income, corporation or similar
taxes) paid to Acorda for the granting to any Third Party any of the rights
granted to Acorda under this Agreement and shall further include any other on
going fees paid to Acorda in respect of such rights, but shall exclude bona
fide research or development fees and payments received by Acorda and any
payments received by Acorda for the sale of the Product from Elan  pursuant to the provisions of
Article 2.11.3.  For the avoidance
of doubt, it is understood and agreed that License Revenues shall not include
and Elan shall not be entitled to receive any share of payments received from a
Third Party for the purchase of equity in Acorda, debt financing, the licence
of intellectual property other than the Elan  Intellectual
Property, rights to products other than the Product or the reimbursement of patent
or other expenses incurred by Acorda; provided that License Revenues shall
include and Elan shall be entitled to receive any share of payments received
from a Third Party for the purchase of equity in Acorda where such payments or
a portion thereof are referable to the granting of rights to the Elan
Intellectual Property for the Product. 
The fact that a premium is paid by a Third Party for the purchase of
equity in Acorda shall not of itself mean that the premium is referable to the
granting of rights to the Elan Intellectual Property for the Product.  For the avoidance of doubt, the Parties
hereby confirm that the definition of License Revenues does not include
royalties calculated as a percentage of NSP or of net In Market sales payable
in each case by Designees to Acorda.


 


“Major European Markets” shall mean
each of the United Kingdom, France, Germany and Italy.


 


“Manufacturing Cost” shall have the same
meaning as in the Supply Agreement.


 


“Merck Agreement” shall mean the Technology
Transfer and License Agreement dated 26 July 1999 between Merck & Co.
Inc. (“Merck”), Elan, Elan
Pharmaceutical Research Corp. (now EDDI) and Elan Pharma International Limited.


 


“MS” shall mean multiple sclerosis.


 


6

















 


“MS Field” shall mean use as an oral
prescription medicine for the treatment of MS in humans.


 


“MS R & D” shall mean MS Research and
Development Corporation, a Delaware corporation, having an office at 15 Skyline
Drive, Hawthorne, New York 10532 USA.


 


“MS Term” shall mean shall mean the period
beginning on 21 April 1998 and ending upon expiry or termination of this
Agreement, howsoever arising.


 


“NDA” shall mean the new drug application as
defined in the Act and applicable regulations promulgated thereunder including
any supplements or amendments thereto, which Acorda may file for the Product
with the FDA.


 


“NDA Approval” shall mean the final approval
to market the Product by the FDA as defined under the Act.


 


“NDA Equivalent” shall mean any new
registration application or submission including any supplements or amendments
thereto, such as a foreign counterpart to the NDA, which Acorda may file for
the Product with any regulatory authority in any regulatory jurisdiction in the
Territory other than the United States that is required to obtain Regulatory
Approval in such jurisdiction.


 


“NDA Timeline” shall mean the development
and regulatory timeline attached hereto as Schedule 4.


 


“Notional NSP” shall mean the estimated NSP
of Product at the applicable time, which shall on a country-by-country basis be
provided by Acorda to the Committee within ninety (90) days prior to
commencement of each calendar year (or, for the Launch Year in any country,
within ninety (90) days prior to the estimated date of First Commercial Sale in
such country); provided, that:


 


(a)                                  for (i) the Launch
Year and (ii) if no Statement is due to be produced prior to ninety (90) days
prior to the estimated date of First Commercial Sale in such country, the
Notional NSP shall be estimated in good faith; and


 


(b)                                 in each subsequent
year, Notional NSP shall be calculated by reference to the average NSP in that
country as evidenced by the last four Statements (or such lesser number of
Statements as have actually been produced in relation to that country).


 


“NSP” shall mean that sum determined by
deducting from the gross amount billed, however characterized, for the Product,
commencing on the date of First Commercial Sale and sold In Market by Acorda or
an Acorda Designee, the following:


 


(a)                                  transportation charges
or allowances, including freight pick-up allowances, and packaging costs, if
any;


 


7

















 


(b)                                 trade, quantity or
cash discounts, service allowances and independent broker’s or agent’s
commissions, if any, allowed or paid;


 


(c)                                  credits or
allowances, if any, given or made on account of price adjustments, returns up
to ten per cent (10%) of gross sales, off-invoice promotional discounts,
rebates, any and all national, federal, state or local government rebates,
whether in existence now, or enacted at any time during the term of this
Agreement, rejections, recall or Product destruction (voluntarily made or
requested or made by an appropriate government agency sub-division or
department) for the Product; and


 


(d)                                 any duty, tariff or
tax (other than income or corporation tax), excise or governmental charge upon
or measured by the production, import, export, sale, transportation, delivery,
or use of the Product.


 


In
the event that Acorda or its Designee shall sell the Product together with
other products to third parties in a particular country and the price
attributable to the Product is less than the average price of “arms length”
sales of the Product alone in the particular country for the reporting period
in which sales occur (such sales to be excluded from the calculation of the
average price of “arms length” sales), NSP for any such sales shall be the
average price of “arms length” sales by Acorda or its Designee of the Product
alone and in the country during the reporting period in which such sales occur.  If the average price of
“arms length” sale of the Product cannot
be determined in any given country, the NSP will be determined by the value of the Product sold to similar
customers in countries with similar pricing and reimbursement structures and
for similar quantities.  Any dispute as
to the determination of fair market value that cannot be resolved through
discussion between the Parties shall be determined by an independent arbitrator
in accordance with the provisions of Article 12.14.


 


“Other Indication Field” shall mean use as a
prescription medicine for the treatment of any condition in humans, excluding
the SCI Field and the MS Field, but for the avoidance of doubt including the
treatment of SCI and/or MS otherwise than orally.


 


“Other Indication Term” shall mean the
period beginning on the Amendment Date and ending upon expiry or termination of
this Agreement, howsoever arising.


 


“Party” shall mean Acorda or Elan, as the
case may be.


 


“Parties” shall mean Acorda and Elan.


 


“Patheon Agreement”  shall mean the Technical Transfer Program
Proposal for Commercial Registration entered into by and between Patheon, Inc.
(“Patheon”) and Acorda dated as of February 26, 2003 relating to the
manufacturing of Fampridine tablets.


 


“Phase 3 Clinical Study”  shall  mean
a clinical trial conducted after an End of Phase 2 Meeting and conducted on a
sufficient number of patients that is designed to establish that the Product is
safe and efficacious for its intended Indication and is intended to


 


8

















 


define
warnings, precautions and adverse reactions that are associated with Product in
the dosage range and formulation to be prescribed, and to support Regulatory
Approval of Product for such Indication.


 


“Product” shall mean any finished
pharmaceutical dosage form containing the Compound or an Alternate Compound,
which is in the scope of one or more Valid Claims within the Elan  Patent Rights in the country of sale,
and/or incorporates Elan  Know-How
in material part.  The use of the
pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods,
clinical protocols and data developed for and on behalf of Elan (except for
tests and studies conducted by or on behalf of Acorda as contemplated by this
Agreement), which is included in the Elan Know-How shall constitute
incorporation of the Elan  Know-How
in material part.


 


“Project” shall mean all activity undertaken
by Elan and Acorda in order to develop the Product in accordance with the
Development Plan, together with (i) all activity as undertaken by Elan and
Acorda to develop the Fampridine Product for SCI prior to the Amendment Date,
and (ii) all activity as undertaken by Elan, Acorda and MS R & D to develop
the Fampridine Product for MS, prior to the Amendment Date.


 


“Regulatory Approval” shall mean (i) NDA
approval by the FDA in the United States of America, (ii) in the case of the
Major European Markets, approval of the NDA Equivalent by the EMEA in the Major
European Markets (and/or the applicable regulatory authorities in such Major
European Market not failing to provide or rejecting such approval), or (iii)
such approvals as are required in any other country of the Territory to launch
the sale of the Product in the normal course of business, as applicable, in
each case including any required pricing and reimbursement approvals.


 


“Research and Development Cost” shall mean
in the case of research and development being conducted by or on behalf of Elan
in connection with the Project the costs thereof calculated in accordance with
GAAP.


 


“Rush” shall mean Rush-Presbyterian-St.
Luke’s Medical Center.


 


“Rush/Acorda License” shall mean the License
Agreement entered into as of the Amendment Date by and between Rush and Acorda,
and any amendments or supplements thereto, the form of which, including the
schedules thereto, is attached hereto as Schedule 5.


 


“Rush Payments Agreement” shall mean the
Rush Payments Agreement entered into as of the Amendment Date by and between
Elan and Acorda, and any amendments or supplements thereto, in connection with
the Rush/Acorda License, a form of which is attached hereto as Schedule 6.


 


“Rush Side Agreement” shall mean the Side
Agreement entered into as of the Amendment Date by and between Rush, Acorda,
Elan and EDDI, and attached as a schedule to the Rush/Acorda License, and
any amendments or supplements thereto.


 


“SCI” shall mean spinal cord injury
indications.


 


9

















 


“SCI Field” shall mean use as an oral
prescription medicine for the treatment of SCI in humans.


 


“SCI Term” shall mean the period beginning
on 23 January 1997 and ending upon expiry or termination of this
Agreement, howsoever arising.


 


“SEC” shall mean the United States
Securities and Exchange Commission or any successor agency thereto.


 


“Specifications” shall mean the
specifications for the Product(s) and API attached as Schedule 7, as they may be modified
from time to time by mutual written agreement of the Parties consistent with
the specifications approved by the FDA in the NDA and, outside the United
States, any NDA Equivalent.


 


“Supply Agreement” shall mean the supply
agreement between Elan and Acorda of even date herewith, in the form attached
hereto as Schedule 8.


 


“Technology Transfer Responsibilities” shall
mean the respective responsibilities of each of Acorda and Elan in connection
with the Project relating, as applicable, to the (i) activities being conducted
under the Cardinal Agreement; (ii) activities being conducted under the Patheon
Agreement, and (iii) procurement of API, as set forth on Schedule 9 hereto, as such
responsibilities may be modified from time to time by mutual agreement of the
Parties.


 


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


 


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


 


“Trademark” shall mean the trademark(s) as
may be selected by Acorda which has been or may be registered by Acorda in one
or more countries of the Territory.


 


“Valid Claim(s)” shall mean a claim in any patent within the Elan
Patents which has not lapsed or become abandoned and which claim has not been
declared invalid by an unreversed or an unappealable decision of a court of
competent jurisdiction.


 


“$” and “US$”
shall mean United States Dollars.


 


1.2.                                   In this
Agreement


 


1.2.1                             the
singular includes the plural and vice versa, the masculine includes the
feminine and vice versa and references to natural persons include corporate
bodies, partnerships and vice versa;


 


1.2.2                             any
reference to an Article, Exhibit or Schedule shall, unless otherwise
specifically provided, be to an Article, Exhibit or Schedule of this
Agreement;


 


10

















 


1.2.3                             the
headings of this Agreement are for ease of reference only and shall not affect
its construction or interpretation; and


 


1.2.4                             the
expressions “include”, “includes”, “including”, “in particular” and similar
expressions shall be construed without limitation.


 


ARTICLE 2 THE LICENSE


 


2.1.                                   License
Grant:


 


Elan
shall remain proprietor of all the Elan Intellectual Property relating to the
Product and any trademark licensed by Elan to Acorda, (such as an acronym for
the applicable technology applied to the Product), but hereby grants to Acorda an
exclusive (even as to Elan) licence under the Elan Intellectual Property in the
Territory to package, use, import, export, promote, distribute, offer for sale,
sell and otherwise exploit and, solely as permitted in the Supply Agreement, to
make and have made:


 


2.1.1                             the
Fampridine Product in the SCI Field for the SCI Term;


 


2.1.2                             the
Fampridine Product in the MS Field for the MS Term; and


 


2.1.3                             without
prejudice to Articles 2.1.1 and 2.1.2, the Product in the SCI Field, MS Field
and/or Other Indication Field for the Other Indication Term, subject to any
contractual obligations of Elan under the Merck Agreement with respect to a
formulation using Nanoformulation technology (as defined in the Merck
Agreement) in the Other Indication Field.


 


in
each case under the terms and conditions set out herein.


 


2.2.                                   Acceptance;
Acorda Non-Competition:


 


Subject
to the provisions of the following sentence, Acorda hereby accepts such licence
and confirms that Acorda and its Affiliates will not directly or indirectly
market as a prescription medicine any other sustained release oral dosage form
or transdermal form, containing the Compound or any other mono-or di-aminopyridine active agent, other
than Product (“Acorda Competing
Product”)  during the
period Acorda retains a licence under the Agreement and for one year
thereafter.


 


Should
Acorda or its Affiliates market an Acorda Competing Product in the countries of
the European Economic Area, Elan reserves as its sole remedy the right to
terminate the exclusive licences granted to Acorda solely in the applicable
country (ies) in which Acorda or its Affiliates market an Acorda Competing
Product, which thenceforth for the remainder of the term of this Agreement
shall become non-exclusive in nature in such countries of the European Economic
Area, and to stop licensing improvements in such countries of the European
Economic Area.


 


11

















 


2.3.                                   Sub-licensing:


 


2.3.1                             Acorda may
sub-license or otherwise authorise one or more third parties (each a Designee)
to use, import, offer for sale, promote, distribute, sell and otherwise exploit
the Product in one or more countries of the Territory (but not the rights to
manufacture the Product which may only be sub-licensed in accordance with the
provisions of the Supply Agreement).  In
circumstances where the third party is entitled to, or is likely to be able to
obtain, access to the CMC Section, the prior written consent of Elan shall be
obtained to any sub-licence or other agreement permitted by this
Article 2.3.1 which consent shall not be unreasonably withheld or
delayed.  In the event that the Third
Party is entitled to access to Confidential Information disclosed by Elan to
Acorda, the agreement between the Third Party and Acorda shall contain obligations
of confidentiality no less onerous than those set out in this Agreement.  Elan shall be furnished with a copy of the
proposed and the executed sub-licence or other agreement contemplated by this
Article 2.3.1  Any sub-licence or
other agreement permitted by this Article 2.3.1 shall be subject to the
terms of this Agreement, but excluding the right to grant a sub-licence.  Acorda shall use its reasonable endeavours
to ensure that Elan shall have the same rights of audit and inspection vis a
vis a Designee, as Elan has pursuant to this Agreement concerning Acorda.  A sub-licence may be granted by Acorda
without any obligation upon the Designee to pay to Acorda or Elan any amounts
other than those set out in this Agreement.


 


2.3.2                             Insofar as
the obligations owed by Acorda to Elan are concerned, Acorda shall remain
responsible for all acts and omissions of any Designee as if such acts and
omissions were by Acorda.  Any
sub-licence or other agreement permitted by Article 2.3.1 shall
automatically and immediately terminate on termination of this Agreement.


 


2.3.3                             For the
avoidance of doubt, the Parties hereby confirm that In Market sales of the
Product by any Designee shall constitute sales by Acorda for the purposes of
Article 5.6.


 


2.4.                                   Use of
Data and Improvements:


 


Subject
to the provisions of Article 12.1 Elan may use the Elan Intellectual
Property and all technical and clinical data or improvements generated by Elan
pursuant to this Agreement in connection with Elan’s commercial arrangements
for the Product in any country which ceases to be a part of the Territory, or
in relation to the Product in the Territory in the event of the termination of
this Agreement.


 


2.5.                                   Rush:


 


Each
of Elan and Acorda hereby acknowledges and agrees that the licences previously
granted to Elan by Rush and the licenses granted to Acorda by Rush pursuant to
the Rush/Acorda License do not constitute Elan Patent Rights or Elan Know-How
for the purposes of this Agreement.


 


12

















 


2.6.                                   Technical
Advice:


 


Without
prejudice to Article 5.1.2, Elan shall, if requested, advise Acorda in any
technical matters as may become necessary for the proper utilisation of the
licence to Acorda pursuant to this Agreement and shall provide reasonable advice
and assistance to Acorda with respect thereto without additional charge.


 


2.7.                                   Combination
Products:


 


In
the event that Acorda wishes to develop, market and sell an oral sustained
release product for the treatment of SCI which contains the Compound or an
Alternate Compound as one of two or more pharmaceutically active ingredients (“Combination Product”), Acorda shall seek
the consent of Elan to extend the licences granted by Elan to Acorda pursuant
to this Agreement, which consent shall not be unreasonably withheld or
delayed.  In the event that such consent
is furnished, the Parties shall negotiate in good faith the terms of an
agreement, including where applicable, such amendments as are appropriate to
this Agreement.


 


2.8.                                   Elan
Competing Product:


 


For
the term of the Agreement, Elan shall not itself or through an Affiliate or
Third Party commercialise or, develop in the Territory nor license another
party in the Territory to commercialise or develop any other sustained release
oral dosage form for prescription use in humans which contains the Compound or
any Alternate Compound as an active ingredient for:


 


2.8.1                             the
indication of SCI; and/or


 


2.8.2                             the
indication of MS; and/or


 


2.8.3                             any other
Indications, subject, during the term of the Merck Agreement, to any
contractual obligations of Elan under the Merck Agreement with respect to a
formulation using Nanoformulation technology (as defined in the Merck
Agreement).


 


(each,
an “Elan Competing Product”).


 


2.9.                                   Trademark:


 


2.9.1                             Acorda
shall market the Product in the Territory under a Trademark, whether during the
Initial Period or thereafter,  which
Trademark will be owned by Acorda.


 


2.9.2                             Elan
grants to Acorda a non-exclusive royalty free licence in the Territory solely
for use in connection with the sale of the Product, for the term of this
Agreement to use any trademark which relates to the Elan technology applicable
to the Product (“Elan Trademark”),
such as an acronym for the applicable technology applied to the Product, on the
following terms:


 


2.9.2.1                           Acorda
shall as soon as it becomes aware of any infringement give to Elan in writing
full particulars of any use or proposed use by any other person, firm or
company of a trade name or trademark or mode


 


13

















 


or
promotion or advertising which amounts to or might amount either to
infringement of Elan’s rights in relation to the Elan Trademark or to passing
off.


 


2.9.2.2                           If Acorda
becomes aware that any other person, firm or company alleges that the Elan Trademark
is invalid or that the use of the Elan Trademark infringes any rights of
another party or that the Elan Trademark is otherwise attacked or attackable,
Acorda shall immediately give to Elan full particulars in writing thereof and
shall make no comment or admission to any Third Party in respect thereof.


 


2.9.2.3                           Elan shall
have the right to conduct all proceedings relating to the Elan Trademark and
shall in its sole discretion decide what action, if any, to take in respect of
any infringement or alleged infringement of the Elan Trademark or passing-off
or any other claim or counter-claim brought or threatened in respect of the use
or registration of the Elan Trademark. 
Any such proceedings shall be conducted at Elan’s expense and for its
own benefit.


 


2.9.2.4                           At no time
during or after the term of this Agreement shall Acorda challenge or assist
others to challenge the Elan Trademark, or the registration thereof or attempt
to register any trademarks, marks, or trade names confusingly similar to the
Elan Trademark.


 


2.9.3                             Acorda
shall not be obliged to use the Elan Trademark to identify the Product but at
Elan’s request shall be obliged to use the Elan Trademark to identify the
applicable Elan technology embodied in the Product.  For the avoidance of doubt, the Parties hereby confirm that
Acorda shall not be entitled to a licence to use any trademark owned or
controlled by Elan which identifies a product, including Neurelan®.


 


2.10.                             When
packaged, and to the extent permitted by law, a product label shall include an
acknowledgement that the Product is made under licence from or, if applicable,
manufactured by Elan.  Such
acknowledgement shall take into consideration regulatory requirements and
Acorda’s commercial requirements, including any requirement to state that
Product is mananufactured by Patheon. 
Acorda shall wherever possible give due acknowledgement and recognition
to Elan in all printed promotional and other material regarding the Product
such as stating that the Product is under licence from, or if applicable,
manufactured by, Elan.  Acorda shall
consult with and obtain the approval of Elan as to the format and content of
the promotional and other material insofar as it relates to a description of,
or other reference to, the application of the Elan Intellectual Property.  It shall be presumed that Elan approved of
such use unless Elan provides written notice of disapproval of such use to
Acorda within thirty (30) days of delivery of such materials to Elan, such
approval not to be unreasonably withheld. 
The further consent of Elan shall not be required where the format and
content of such materials is


 


14

















 


substantively
materially similar as the materials previously furnished to and approved by
Elan.


 


2.11.                             Diligence:


 


2.11.1                       Acorda shall use reasonable efforts
consistent with the reasonable standard as would be applied by a
bio-pharmaceutical company of similar size, stage of development and assets for
a product of the market size and potential of the Product to market and promote
the Product throughout the Territory.


 


2.11.2                       Acorda
shall effect a national commercial launch of the Product in the United States
of America within one hundred and eighty (180) days of NDA Approval, provided
that Acorda shall have received the agreed quantities of Launch Stocks ordered
pursuant to firm purchase orders at least sixty (60) days in advance of the
launch date.  It is agreed that with respect to Japan and
the Major European Markets, Acorda will effect a national commercial
launch of the Product within one
hundred and eighty (180) days after
the necessary Regulatory Approvals, provided that Acorda shall have received
the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders
pursuant to the Supply Agreement at least sixty (60) days in advance of the
projected launch date.  In the
event that Acorda shall have
received the agreed quantities of Launch Stocks ordered pursuant to firm
purchase orders pursuant to the Supply Agreement at least sixty (60) days in
advance of the projected launch date and Acorda does not make a national commercial
launch in one or more of the countries listed above within the one hundred and
eighty (180) day period, or such longer period permitted by the provisions of
this Article 2.11.2, the licences granted to Acorda hereunder shall with
thirty (30) days notice from Elan terminate in the applicable country  and Elan shall be entitled to a licence to
the Acorda Patent Rights and the Acorda Know-How in the applicable country on the
terms set out in Article 2.11.3 and to the Trademark on the terms set out
in Article 2.9.  Notwithstanding
the above, in the event that the Parties disagree whether or not Acorda has
satisfied its obligations under this Agreement in any country listed above, the
matter may be submitted to arbitration by either Party, and Acorda’s rights and
licences shall remain in effect until and unless the arbitrator makes a
decision that Acorda’s right and licence in such country should terminate.


 


2.11.3                       Acorda will
use commercially reasonable efforts to file and obtain registration approval in
the United States of America, the Major European Markets and Japan as soon as
practicable.  In the event of any
failure by Elan to perform its obligations under this Agreement or under the
Supply Agreement which results in Acorda’s failure to obtain such a Regulatory
Approval or any delay thereof, the Parties through the Committee shall make
reasonable and appropriate adjustments to the period in which Acorda shall have
to file to obtain the applicable Regulatory Approval.  If (x) Acorda fails to file to obtain a Regulatory Approval to
commercialise the Product in the United States of America, Japan or the Major
European Markets within a commercially reasonable time after completion and
receipt of positive data from all pre-


 


15

















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.


 


clinical and clinical studies required for the
related NDA or any NDA Equivalent, as determined by the Committee, or (y)
Acorda fails to effect a commercial launch of the Product in the United States
of America, Japan or the Major European Markets within the period specified in
Article 2.11.2 above then, in such event, provided that Elan has
terminated Acorda’s licence as provided in Article 12.5.2.2, Acorda shall,
at the option of Elan, license, make available and transfer to Elan all of
Acorda’s data, information, applications, approvals and filings to permit Elan
to commercialise the Product in the applicable region, in exchange for an
initial payment equal to Acorda’s costs of developing such data, information,
applications, approvals and filings for such region and [*****] of NSP (for
which purpose the definition of NSP as set out in Article 1 shall apply
mutatis mutandis)  of the Product
by Elan and/or its designees (for which purpose the definition of Designee as
set out in Article 1 shall apply mutatis mutandis)  in such region.  In such event Elan shall be entitled to a licence to the Acorda
Patent Rights and the Acorda Know-How to commercialise the Product on the terms
set out in this Article 2.11.3 and to the Trademark on the terms set out
in Article 2.9.  In the event that Elan is entitled
to such licence, the Parties shall enter into a further written licence
agreement which shall include customary and reasonable terms relating to, inter
alia, the timing of royalty payments to Acorda, reporting obligations
regarding net sales, audit rights of Acorda with respect to books and records
relating to net sales, sublicense and indemnity provisions, which obligations
shall, unless otherwise agreed by the Parties, be substantially similar to
those in this Agreement with respect to commercialisation of the Products by
Acorda.


 


2.11.4


 


2.11.4.1                     Acorda
will use its commercially reasonable efforts to obtain Regulatory Approval to
commercialise the Product in the other countries of the Territory that it
selects, having regard to the effort and expenditure required to obtain
Regulatory Approval for the Product and the commercial opportunities for the
Product in such other countries of the Territory.


 


2.11.4.2                     In the
event that the Parties disagree whether Acorda has satisfied its obligations
under Article 2.11.4.1, with regard to one or more of such other countries
of the Territory, the matter may be submitted to the Committee, and if not
resolved by the Committee, by arbitration, by either Party, and Acorda’s rights
and licences shall remain in effect until and unless the arbitrator makes a
decision that Acorda’s right and licence hereunder in such country should
terminate.


 


2.11.4.3                     If Acorda
(a) indicates to Elan that it does not intend to file to obtain Regulatory
Approval and commercialise the Product in a particular country or countries of
the Territory, or (b) fails to commence commercialisation in any country in the
Territory (other than the United States, the Major European Markets {or, if


 


16

















 


commercialization
has commenced in the Major European Markets, any other country subject to the
jurisdiction of the EMEA, provided that Acorda provides to the Committee a
marketing plan for such other countries} or Japan), within one hundred and
(180) days after receiving the required Regulatory Approval therefor, provided that Acorda shall have ordered and
received the agreed quantities of Launch Stocks ordered pursuant to firm
purchase orders pursuant to the Supply Agreement at least sixty (60) days in
advance of the projected launch date, Elan shall be entitled to a licence to the
Acorda Patent Rights and the Acorda Know-How to commercialise the Product in
such countries on the terms set out in Article 2.11.3 and to the Trademark
on the terms set out in Article 2.9.


 


ARTICLE 3 DEVELOPMENT OF THE PRODUCT


 


3.1.                                   Subject to
the provisions of this Article 3, Acorda shall use its reasonable efforts,
as would be deemed commensurate with the achievement of its own business aims
for a similar product of its own to conduct such part of the Project as the
Parties mutually agree shall be conducted by Acorda.  Subject to the provisions of this Article 3, Elan shall use
its reasonable efforts, as would be deemed commensurate with the achievement of
its own business aims for a similar product of its own, to conduct such part of
the Project as the Parties mutually agree that shall be conducted by Elan. The
allocation between the Parties of their respective responsibilities for
conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and
(ii) shall be set forth in a development plan (the “Development Plan”) to be prepared and updated from time to
time by Acorda in consultation with Elan, relating to the development of the
Product, the current form of which is attached as Schedule 4 - NDA Timeline, and the Committee shall
monitor the progress of such activities. 
Elan and Acorda each undertake that it shall carry out the respective
studies, testing and activities set forth as Technology Transfer
Responsibilities, in the Development Plan, and otherwise undertaken and
conducted by it in good faith and in accordance with prevailing cGCP and cGLP
and FDA standards and guidelines.


 


3.2.                                   Provided
that Elan uses reasonable endeavours to meet its obligations under this
Agreement, Elan shall have no liability to Acorda as a result of any failure or
delay of the Product to achieve one or more of the milestones set out in the
Project and/or to obtain the NDA Approval or the approval of the regulatory
authorities in one or more of the other countries of the Territory.  Acorda shall have no liability to Elan as a
result of any failure or delay of the Product to obtain the NDA Approval or the
approval of the appropriate health regulatory authorities in one or more of the
countries of the Territory.


 


3.3.                                   The
Parties hereby confirm that each shall undertake its respective part of the
Project as a collaborative effort and that the provisions of this Agreement
requires that each Party diligently carries out those tasks assigned to it
under the Project and as otherwise agreed during the course of the
Project.  Each Party shall co-operate
with the other in good faith particularly with respect to unknown problems or
contingencies and shall perform its


 


17

















 


obligations
in good faith and in a commercially reasonable, diligent and workmanlike
manner.  Each Party will update the
other Party on the progress of the Project at meetings of the Committee.


 


3.4.                                   Elan will
supply Acorda with Acorda’s reasonable requirements of Product  including clinical trial supplies to
enable Acorda to carry out the Project. 
The Product shall be supplied by Elan EXW at Manufacturing Cost.


 


3.5.                                   Acorda
agrees to carry out and complete the Phase III programme in the United States
of America to a standard and timeframe that a company of comparable size, stage
of development and assets would use for a product of similar size and potential
as the Product.


 


3.6.                                   With
respect to generating stability data on the oral Product in bulk tablet form,
Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the
MS Agreement, Elan had the responsibility for generating such data, (ii)
pursuant to the Cardinal Agreement, Cardinal is currently performing such
stability testing, (iii) the Technology Transfer Responsibilities shall govern
the related responsibilities of the Parties, provided that the data resulting
from such stability testing shall be provided to both Acorda and Elan, and Elan
shall have the right to and responsibility for providing necessary and
appropriate technical assistance and oversight of such stability testing (including
having the right at its own expense to arrange for its employees involved in
the Project to discuss the stability testing and its results with the technical
personnel of Acorda and Cardinal upon reasonable notice and at reasonable
times); and  (iv) Elan shall
incorporate such stability data into the CMC module that it will prepare for
delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to
Article 3.8.


 


3.7.                                   For the
avoidance of doubt, the Parties hereby confirm that a primary objective of the
Project is to generate the NDA and secure NDA Approval for the oral
Product.  As of the date of the SCI
Agreement, the MS Agreement and the Amendment Date, it is the Parties’
expectation that the body of data so generated in the Project will also support
such applications for Regulatory Approval that Acorda shall make in the other
countries of the Territory.  In the
event however that such expectation proves unfounded or incorrect and further
data is required to obtain such other approvals as are pursued by Acorda in the
other countries of the Territory, Acorda shall determine the viability of
proceeding further with the regulatory application and generation of the
further data requirements.  In the event
that Acorda elects to continue, the Parties shall update the Development Plan
to reflect the allocation between the Parties of conducting such additional
activities. 
In such event, subject to and in accordance with the
provisions of this Article 3, Elan shall be responsible for conducting such
further activities and generating such further data as set forth in the
Development Plan to allow Acorda to seek such further Regulatory Approvals in
the Territory. Notwithstanding the foregoing, it is intended by the Parties
that except as otherwise specifically set forth in a Development Plan agreed to
by the Parties and subject to compliance with regulatory requirements, Acorda
shall have primary responsibility and decision making authority with respect to
development and marketing of Product.


 


18

















 


3.8.                                   Elan shall
be responsible for the preparation and delivery to Acorda of the CMC
Section in electronic and hard copy form and the latter in format suitable
for inclusion in the NDA and any NDA Equivalent in accordance with applicable
law and regulatory standards and as the Parties may mutually agree.  Acorda shall provide Elan as soon as
practicable with a copy of any comments received by Acorda from the FDA or any
other regulatory authority relating to the CMC Section and Elan shall
provide or, at Acorda’s request, cooperate with Acorda to provide, a response
to such comments as soon as practicable. In the event that there is a
deficiency in the CMC Section attributable to negligence by Elan in the
activities conducted by Elan, then Elan shall be responsible for correcting
such deficiency, at Elan’s expense, and shall use reasonable efforts to do so
as soon as practicable. In the event Elan breaches the foregoing obligation, in
addition to any other remedies available to Acorda, Acorda shall have the right
to correct such deficiency or arrange to have a Third Party conduct any
required activities necessary to correct such deficiency, at Elan’s expense,
the cost of which may be offset against any amounts otherwise due Elan under
this Agreement.  Acorda shall be
responsible for the maintenance of the CMC Section in accordance with
applicable law and regulatory standards, at Acorda’s expense, provided that (i)
Elan shall cooperate with and provide reasonable assistance to Acorda in
connection with such maintenance; and (ii) any revisions, amendments or
supplements to the CMC Section required by or resulting from the
negligence of Elan in performing its obligations hereunder or under the Supply
Agreement, or from any action taken by Elan on its own initiative, or taken by
Acorda or any Acorda Designee on behalf of or at the request of Elan, including
any changes made by Elan on its own initiative to its manufacturing processes
or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any
changes to its manufacturing processes or facilities that would require an
amendment or supplement to the CMC Section without first notifying Acorda
of such changes and preparing and delivering to Acorda any required amendments
or supplements to the CMC Section before the implementation of such
changes.


 


If
Elan is required in any regulatory jurisdiction to file with any regulatory
authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost
prepare and file in accordance with applicable regulatory requirements such DMF
and Acorda shall have a right of reference thereto to the extent required by
the NDA or any NDA Equivalent or in order to exercise its license rights under
this Agreement.


 


Similarly,
if Elan is entitled to market, distribute and sell the Product in a particular
country, and Acorda is required in any regulatory jurisdiction to file with any
regulatory authority a DMF relating to Compound or Product, Acorda shall at
Elan’s cost prepare and file in accordance with applicable regulatory
requirements such DMF and Elan shall have a right of reference thereto to the
extent required by the NDA or any NDA Equivalent or in order to exercise its
rights under this Agreement.


 


ARTICLE 4 [NOT USED]


 


19

















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.


ARTICLE 5 FINANCIAL PROVISIONS


 


5.1.                                   Research
and Development Activities:


 


5.1.1                             In
consideration for the research and development of the Product by Elan under
this Agreement, Acorda shall pay to Elan the amounts set out in
Article 5.1.2.


 


5.1.2                             Research
and Development Cost incurred by Elan after the Amendment Date and before
commercial launch of the Product shall be invoiced and payable monthly, at a
rate of FTE plus [***].


 


5.1.3                             Elan will keep accurate records consistent
with its normal business practices, of the efforts expended by it under the
Project for which it is charging Acorda, which will include the time spent by
each person working on the Project. 
Each quarter Elan will send reports to Acorda in order to enable Acorda
to monitor Elan’s level of effort to assure Acorda that the committed level of
effort is being applied.


 


5.1.4                             If Elan’s development efforts require the use
of a Third Party, Elan will, prior to appointing such Third Party, discuss with
Acorda the activities to be undertaken by such Third Party and the terms and
conditions thereof.  Elan will not
proceed with such Third Party without the prior written approval of Acorda,
which approval shall not be unreasonably withheld. Elan shall charge
Acorda for the time spent by its employees in administering the work conducted
by such Third Parties on the
basis set out in Article 5.1.2. 
Elan shall have the right to charge Acorda for all reasonable out of
pocket expenses incurred in the provision of its obligations thereunder.


 


5.2.                                   License
Royalties:


 


5.2.1                             In
consideration of the rights and licence granted to Acorda to the Elan Patent
Rights by virtue of the SCI Agreement, Acorda has paid to Elan $[****]; and


 


5.2.2                             In
consideration of the rights and licence granted to MS R & D to the Elan
Patent Rights by virtue of the MS Agreement, MS R & D has paid to Elan
$[****] –


 


receipt
of each of which is hereby acknowledged by Elan.


 


5.3.                                   Milestone
Payments:


 


5.3.1                             In further
consideration of the rights and license granted to Acorda to the Elan Patent
Rights hereunder, Acorda shall pay to Elan the following non-refundable amounts
contingent upon occurrence of the specified event, with each milestone payment
to be made no more than once with respect to the achievement of such event (but
payable the first time such milestone is achieved) for Product:


 


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.


 


5.3.1.1               [****] 90 (ninety)
days after written receipt of NDA Approval of the Product for the first
Indication;


 


5.3.1.2                           [***] on
the earlier of (a) 90 (ninety) days after written receipt of NDA Approval of
the Product for a second Indication or (b) the 2nd (second)
anniversary of NDA Approval of the Product for the first Indication;


 


5.3.1.3                           [***] upon
the commencement of a Phase III Clinical Study of the Product for a third
Indication;


 


5.3.1.4                           [***] upon
acceptance by the FDA for filing of the NDA for a third Indication;


 


5.3.1.5                           [***] upon
written receipt of NDA Approval of the Product for a third Indication;


 


5.3.1.6                           [***] upon
First Commercial Sale of the Product for a third Indication;


 


5.3.1.7                           [***] upon
the commencement of a Phase III Clinical Study of the Product for a fourth
Indication;


 


5.3.1.8                           [***] upon
acceptance by the FDA for filing of the NDA for a fourth Indication;


 


5.3.1.9                           [***] upon
written receipt of NDA Approval of the Product for a fourth Indication; and


 


5.3.1.10                     [***] upon
First Commercial Sale of the Product for a fourth Indication –


 


the
payments described in Articles 5.3.1.1 to 5.3.1.10 being “Milestone Payments”.


 


5.3.2                             The
Milestone Payments referred to in Articles 5.3.1.3 through 5.3.1.10 shall be
payable within forty five (45) days after achievement of the applicable
milestone event.


 


5.3.3                             For the
avoidance of doubt, references in this Article 5.3 to an Indication by
number are to the number of Indications for which a particular milestone has
been achieved.


 


By
way of example, the Milestone Payment in Article 5.3.1.9 shall become
payable upon NDA Approval for a Indication “E”, where Indications “A”, “B”


 


21

















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.


 


 


and
“C” have already received NDA Approval, notwithstanding that commencement of a
Phase III Clinical Study of the Product and/or NDA filing for Indication “D”
may have occurred before commencement of such studies for Indication “E”.


 


5.3.4                             In respect
of each of the third and fourth indication of the Product, in the event that
Acorda spends in excess of [***] on Phase III Clinical Studies for such
indication, Acorda shall be entitled to credit one half of the excess spend in
respect of that indication, over and above [***] per indication, against the
respective Milestone Payments for that indication, viz. the Milestone Payments
referred to in Articles 5.3.1.4 and 5.3.1.5 for the third indication and the
Milestone Payments referred to in Articles 5.3.1.8 and 5.3.1.9 for the fourth
indication, up to a maximum of [****] for each indication.


 


5.3.5                             The
Milestone Payments shall not be subject to future performance obligations of
Elan to Acorda and shall not be applicable against future services provided by
Elan to Acorda.


 


5.4.                                   Certain
Payments relating to Rush/Acorda License:


 


Elan
shall reimburse Acorda in respect of the milestone payments payable from Acorda
to Rush pursuant to Section 5.2 of the Rush/Acorda License and Acorda
shall pay Elan an additional royalty, each in accordance with and subject to
the terms and conditions of the Rush Payments Agreement.


 


5.5.                                   License
Revenues:


 


In
further consideration of the rights and licence granted to Acorda to the Elan
Patent Rights by virtue of this Agreement, Acorda shall pay to Elan [***] of
all and any License Revenues.


 


5.6.                                   Royalty on
Sales:


 


5.6.1                             Subject to
Article 5.6.2 and in further consideration of the rights and license
granted to Acorda to the Elan Patent Rights while there is a Valid Claim
thereunder, and in consideration of the rights and license granted to Acorda of
the Elan Know-How thereafter, Acorda shall additionally pay to Elan a royalty
of [***] of the NSP of the Product (the “Elan
Royalty”). The Elan Royalty shall be payable as follows:


 


5.6.1.1                           In respect
of the Elan Royalty, where Elan manufactures and supplies the Product, Elan
shall render an invoice in respect of the quantities of Product delivered to
Acorda for a sum calculated by reference to [***] of the Notional NSP and the
quantity of Product supplied.  For the
avoidance of doubt the Parties agree that if for whatever reason the Product
supplied by Elan to Acorda which meets the Specifications and the applicable
law and regulatory


 


22

















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.


 


 


requirements
is not sold by Acorda, payment to Elan for such Product shall nonetheless be
effected and the price of the Product shall be determined by reference to the
NSP calculated pursuant to the provisions of Article 5.6.1.2.


 


5.6.1.2                           Within
forty five (45) days of the end of each calendar quarter, Acorda shall notify
Elan of the prevailing NSP for Product sold in the previous quarter.  Acorda shall calculate the total Elan
Royalty payable to Elan for the Product supplied by Elan during the previous
quarter by reference to [***] of the NSP. The Parties shall adjust their
account by Acorda promptly paying to Elan, or by Elan crediting Acorda against
the price of Product to be supplied (as the case may be), the difference
between the sum paid pursuant to Article 5.6.1.1 and the sum calculated
pursuant to this Article 5.6.1.2.


 


5.6.1.3                           In respect
of the Elan Royalty, where Elan does not manufacture and supply the Product,
within forty five (45) days of the end of each calendar quarter (for the first
two years following first commercial sale of the Product in any country of the
Territory, within sixty (60) days of the end of each quarter), Acorda shall
notify Elan of the prevailing NSP of Product sold in that preceding quarter and
of the quantity of Product sourced from third parties.  The Elan Royalty in respect of such Product
shall each be payable on the date on the date such report is due.


 


5.6.2                             In
countries where there are no Valid Claims covering the Product and if there is
no Competition, Acorda shall pay to Elan the applicable Elan Royalty set forth
in Article 5.6.1 for sales in such countries; provided, if, and only if,
(a) Elan is not manufacturing the Product, (b) there are no Valid Claims
covering the Product and (c) there is Competition in any such country, the Elan
Royalty due under Article 5.6.1 on Product sales in such country shall be
reduced to [***] of NSP provided, however, that in the event there is
Competition in any country, the Parties agree to discuss, considering market
conditions, further reducing the Elan Royalty.


 


5.6.3                             In the
event that Elan or its subcontractor does not manufacture and supply the
Product and in the event that Acorda enters into a licence agreement with any
Third Party with respect to a Dominating Patent, or to avoid or settle a claim
by a Third Party for infringement or misappropriation by any Elan Intellectual
Property right relating to the manufacture, use or sale of the Product, Acorda
may offset any payments made in accordance with such licence agreements against
any royalty amounts (and not amounts in respect of manufacturing) owed by
Acorda to Elan, up to a maximum of [***] of the royalty amounts due.  For the purpose of this Article 5.6.3
the Parties hereby confirm that the minimum Elan Royalty payable by Acorda to
Elan shall be [***] of the NSP. Any dispute under this Article 5.6.3
(including one as to


 


23

















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


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


Commission.


 


 


whether
Acorda should have entered into such agreement) shall be resolved by referring
such matter to an independent patent attorney for arbitration, and in the event
of such a dispute the offset above shall only take effect prospectively upon an
arbitrator’s decision in favour of Acorda. 
In such event the procedure set forth in Article 12.14 shall to the extent
practicable apply to the conduct of such arbitration.


 


5.6.4                             No more
than one royalty payment shall be due with respect to a sale of a particular
Product (except any royalty payable under the Rush Payments Agreement).  No multiple payments shall be payable
because any Product or its manufacture, sale or use is covered by more than one
Valid Claim covering the Product.  No
royalty payments shall be payable with respect to Products distributed for use
in research and/or development, in clinical trials or as promotional samples.


 


5.6.5                             All
payments due hereunder shall be made in United States Dollars in accordance
with Article 5.9.


 


5.6.6                             For the
avoidance of doubt, the Elan Royalty and any royalty payable under the Rush
Payments Agreement shall be payable whether or not Elan is manufacturing and
supplying the Product.


 


5.7.                                   Additional
Expenses:


 


Acorda
shall pay Elan within thirty (30) days of the date of invoicing for any
technical assistance requested by Acorda, including travel and subsistence,
provided that Elan is not otherwise obliged to provide such assistance pursuant
to the terms of the Agreement.  Elan’s
charges for such work shall be Research and Development Cost plus [***], as
well as reimbursement for out-of pocket expenses incurred by Elan to Third
Parties in performing activities under the Development Plan that are not already
included in Research and Development Cost.


 


5.8.                                   Non-Refundable
Payments:


 


All
payments received by Elan from Acorda under Article 5 shall be
non-refundable, subject to the provisions of Article 5.9.5.


 


5.9.                                   Payments, Reports and Records:


 


5.9.1                             Acorda shall keep and shall cause its
Affiliates and Designees to keep true and accurate records of gross sales of
the Product, the items deducted from the gross amount in calculating the NSP,
the NSP and the royalties payable to Elan under Article 5 hereof. 
Acorda shall deliver to Elan a written statement thereof within forty
five (45) days following the end of each calendar quarter (or any part thereof
in the first or last calendar quarter of this Agreement) for such calendar
quarter.  The said written statements
shall set forth on a country-by-country basis, the calculation of the NSP from
gross revenues during that calendar quarter, the applicable percentage rate,
and a computation of the sums due to Elan (the “Statement”).  The
Parties’ financial officers shall agree upon the 


 


24

















 


precise format of the
Statement. Acorda shall also provide Elan with preliminary monthly sales
reports in a format to be determined by the Committee.


 


5.9.2                             Payments
due on NSP of the Product based on sales amounts in a currency other than
United States Dollars shall first be calculated in the foreign currency and
then converted to United States Dollars on the basis of the exchange rate in
effect for the purchase of United States Dollars with such foreign currency
quoted in the Wall Street Journal (or comparable publication if not quoted in
the Wall Street Journal) with respect to the sale of currency of the country of
origin of such payment for the day prior to the date on which the payment by
Acorda is being made.  In order to facilitate the payments, the
Parties may agree that with respect to a certain country or countries the
payments due with regard to Product sales in such country or countries will be
paid directly by the Acorda Designee(s) responsible for the marketing of the
Product in such country or countries to Elan. 
In remitting such royalty payments such Designees(s) will abide by the
terms of this Article 5.9.  No such direct payments will be made by any
Acorda Designee unless Acorda and Elan have beforehand agreed that such direct
royalty payment and such direct payments shall not adversely affect the
withholding liability of Elan compared to the payments made by Acorda to Elan.


 


5.9.3                             If laws,
rules or regulations require withholding of income taxes or other taxes imposed
upon payments set forth in this Article 5, Elan shall provide Acorda,
prior to any such payment, once each calendar year 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).  Any such income or other taxes which Acorda is required by law to pay
or withhold on behalf of Elan with respect to royalties and any other monies
payable to Elan under this Agreement shall be deducted from the amount of such
NSP payments, royalties and other monies due. 
Acorda shall furnish Elan with proof of such payments.  Any such tax required to be paid or withheld
shall be an expense of and borne solely by Elan.  Acorda shall promptly provide Elan with a certificate or other
documentary evidence to enable Elan to support a claim for a refund or a
foreign tax credit with respect to any such tax so withheld or deducted by
Acorda.  Both Parties will reasonably
cooperate in completing and filing documents required under the provisions of
any applicable tax treaty or under any other applicable law, in order to enable
Acorda to make such payments to Elan without any deduction or withholding.


 


5.9.4                             All payments due hereunder shall be made to
the designated bank account of Elan in accordance with such timely written
instructions as Elan shall from time to time provide.


 


5.9.5                             For the
twenty four (24) month period following the close of each calendar year during
the term of the Agreement, Elan and Acorda will provide each other’s
independent certified accountants (reasonably acceptable to the other Party)
with access, during regular business hours and upon reasonable prior request
and


 


25

















 


subject
to the confidentiality provisions as contained in this Agreement, to such
Party’s books and records relating to the Product, solely for the purpose of
verifying the accuracy and reasonable composition of the calculations hereunder
for the calendar year then ended, including in the case of Elan the sums
payable by Acorda to Elan pursuant to Article 5. If such accounting firm
concludes that additional royalties were owed during such period then Acorda
shall pay the additional royalties within sixty (60) days after the date of
delivery of such accounting firm’s written report so concluding.  In the event such accounting firm concludes
that amounts were overpaid by Acorda during such period, Elan shall repay
Acorda the amount of such overpayment within sixty (60) days after the date of
delivery of such accounting firm’s written report so concluding.


 


5.9.6                             In
addition, for the twenty four (24) month period following the close of each
calendar year, Elan will provide Acorda’s independent certified accountants
(reasonably acceptable to Elan) with access, during regular business hours and
upon reasonable prior request and subject to the confidentiality provisions as
contained in this Agreement, to Elan’s books and records relating to (i) the
Manufacturing Cost of the Product; (ii) any activities undertaken by Elan on
behalf of Acorda pursuant to Article 3; and (iii) any activities
undertaken by Elan on behalf of Acorda pursuant to Article 6, in each
case, for the purpose of verifying the reasonable basis of the payments made by
Acorda hereunder with respect thereto.


 


5.9.7                             Notwithstanding
any other provision of this Agreement, if at any time legal restrictions
prevent the prompt remittance of part or all of the payments due to Elan in any
country, payment shall be made through such lawful means or methods as Acorda
may determine after consultation with Elan. 
When in any country the law or regulations prohibit both the transmittal
and deposit of royalties on sales in such a country, payments shall be
suspended for as long as such prohibition is in effect 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, 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.


 


ARTICLE 6 REGISTRATION
OF THE PRODUCT


 


6.1.                                   As is
stated at Article 3.7, a primary objective of the Project is to generate
the NDA and to secure NDA Approval.  As
of the date of this Agreement, it is the Parties’ expectation that the body of
data so generated during the Project will support such applications for
Regulatory Approval that Acorda shall make in the other countries of the
Territory.


 


26

















 


6.2.                                   Subject to
the review by the Committee pursuant to Article 10 and to Elan’s
preparation and delivery to Acorda of the CMC Section in form and
substance acceptable for inclusion in the NDA (as well as any revisions thereto
as may be mandated or requested by the FDA), and to the other provisions of
this Article 6, Acorda shall have the right and responsibility for filing,
shall use its reasonable efforts to prosecute to approval, and shall own the
NDA.  It is acknowledged that Elan has
assigned the IND to Acorda.  Within
ninety (90) days following the completion of the Project as determined by the
Committee, Acorda shall submit the NDA for filing with the FDA.


 


6.3.                                   Acorda
shall not alter the Specifications or any part of the CMC Section unless
(a) by agreement with Elan, or (b) mandated by the FDA or other regulatory
authority.  In either case, Acorda shall
promptly notify Elan and for changes made after NDA Approval, shall be
responsible for Elan’s reasonable expenses associated with required changes to
its manufacturing license(s).


 


6.4.                                   Subject to
Elan preparing and delivering to Acorda the CMC Section as set forth in
this Agreement, Acorda shall be responsible for obtaining all Regulatory
Approvals necessary for Elan to package the Product into final market
packaging.  Acorda shall be responsible
for obtaining all applicable FDA and other state and local regulatory approvals
for the distribution of the Product in the United States of America and
elsewhere.  Elan shall co-operate with
Acorda in obtaining such approvals.


 


6.5.                                   Acorda
shall maintain at its own cost the NDA (and shall bear the cost of any
amendments or supplements to the CMC Section, other than those requested by
Elan, which costs shall be borne by Elan) with the FDA during the period that
Acorda and/or its Designees are marketing the Product.  Acorda shall continue to maintain the NDA
with the FDA, at Elan’s request and expense, if Elan acquires the right to a
licence in the United States or any other country in which the NDA is relied
upon as the primary application for Regulatory Approval pursuant to
Article 2.11.3 for such term thereafter during which Elan and/or its designees
(for which purpose the definition of Designee as set out in Article 1
shall apply mutatis mutandis) is marketing the Product.  Acorda hereby agrees to provide to Elan a
copy of the NDA within thirty (30) days of the submission thereof to the FDA.  Acorda shall also furnish a copy to Elan of
all other regulatory filings and other material correspondence with the FDA and
other regulatory authorities within thirty (30) days of submission.  The NDA and any NDA Equivalent or
application for Regulatory Approval filed in Territory for the Product shall
remain the property of Acorda, provided that Acorda shall allow Elan access
thereto to enable Elan to fulfil its obligations and exercise its rights
hereunder.


 


6.6.                                   During the
NDA registration procedure, Acorda shall keep Elan promptly and fully advised
of Acorda’s registration activities, progress and procedures during Committee
meetings.  Elan and Acorda shall each
before proceeding with any FDA filings, meetings or telephone conferences,
inform and discuss the participation of the other with respect to any such
proposed dealings with the FDA relating to the Product and shall promptly
provide to that other copies of all correspondence with, and all documents and
applications filed with, or submitted by it to, any regulatory authority with
respect to Product; provided, however, that that the Parties acknowledge and
agree that Acorda


 


27

















 


shall
be the primary contact with the FDA and any other regulatory authority in the
Territory with respect to Product.


 


6.7.                                   It is
hereby acknowledged that there are inherent uncertainties involved in the
development and registration of pharmaceutical products with the FDA or any
other regulatory body in the United States of America insofar as obtaining
approval is concerned and that such uncertainties form part of the business
risk involved in undertaking the form of commercial collaboration as set forth
in this Agreement. Therefore, save for using its reasonable efforts, neither
Party shall have any liability to the other solely as a result of any failure
of the Product to achieve the approval of the FDA, or any other regulatory body
in the United States of America.


 


6.8.                                   Acorda
shall also be responsible for the filing and prosecution at its own cost of the
regulatory applications with the regulatory authorities in Japan, the Major European Markets and in
such other countries of the Territory as it elects and Elan shall cooperate
fully with Acorda in connection with such activities.  The provisions of Articles 6.1 to 6.7 inclusive shall apply,
mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such
other countries of the Territory.


 


ARTICLE 7
[NOT USED]


 


ARTICLE 8 WARRANTY AND INDEMNITY


 


8.1.                                   Elan
represents and warrants that Elan is the sole and exclusive owner or licensee
of, or controls all right, title and interest in the Elan Intellectual
Property; Elan has the right to grant the rights and licences granted herein,
and the Elan Intellectual Property as it pertains to the Product  and the Product is free and clear of any
lien, encumbrances, security interest) or restriction on license; Elan will not
grant during the term of this Agreement, any right, licence or interest in and
to the Elan Intellectual Property or the Product, or any portion thereof,
inconsistent with the licence granted to Acorda herein; and there are no
pending or, to the knowledge of Elan, threatened, actions, suits,
investigations, claims or proceedings in any way related to the Elan
Intellectual Property or the Product. 
Insofar as such patent rights and know-how constitute Elan Patent Rights
or Elan Know-How for the purposes of this Agreement,  Elan represents and warrants that it is entitled to grant a
licence to such patent rights and know-how as are developed by or on behalf of
Elan pursuant to the Axogen Agreement, including any patent rights and
non-patented know-how or other information which may be conceived, reduced to
practice or otherwise developed by or on behalf of Elan pursuant to the Axogen
Agreement.  Elan agrees to hold Acorda
harmless from any and all costs, expenses and damages (including reasonable
attorneys’ fees) incurred or sustained by Acorda as the result of any Third
Party’s challenges to Elan’s right to enter into this Agreement and to grant
the rights and licences herein granted to Acorda and the Elan Intellectual
Property.


 


8.2.                                   Elan
represents and warrants that the execution of this Agreement and the full
performance and enjoyment of the rights of Acorda under this Agreement will not
breach or in any way


 


28

















 


be
inconsistent with the terms and conditions of any licence, contract,
understanding or agreement, whether express, implied, written or oral between
Elan and any Third Party.


 


8.3.                                   Acorda
represents and warrants that it has not granted any option, licence, right or
interest in or to the Compound or to the Acorda Patent Rights to any Third
Party which would conflict with the terms of this Agreement.  Acorda agrees to hold Elan harmless from any
and all costs, expenses and damages (including reasonable attorneys’ fees)
incurred or sustained by Elan as the result of any Third Party’s challenges to
Acorda’s right to enter into this Agreement.


 


8.4.                                   Acorda
represents and warrants that the execution of this Agreement will not breach or
in any way be inconsistent with the terms and conditions of any licence,
contract, understanding or agreement, whether express, implied, written or oral
between Acorda and any Third Party.


 


8.5.                                   Each Party
represents and warrants that with respect to all data and information generated
by it to support regulatory filings seeking to obtain approval of the
regulatory authorities shall, to the best of that party’s knowledge, be free
from fraud or material falsity and shall be accurate and reliable for purposes
of supporting approval of the submissions. 
Each Party warrants that all regulatory applications made by that Party
have not been and will not be obtained either through bribery or the payment of
illegal gratuities, and that no Regulatory Approval shall be obtained with
illegal or unethical behaviour of any kind.


 


8.6.                                   Elan
represents and warrants that the Product supplied to Acorda by Elan under this
Agreement has been and shall be free of any lien, security, interest or other
encumbrance on title, conform to the Specifications and in accordance with all
regulations and requirements of the FDA and foreign regulatory authorities
including, without limitation, the cGMP regulations which apply to the
manufacture, storage, packaging and supply of the Product.  Elan represents and warrants that the
Product supplied to Acorda under this Agreement has been and shall be free of defects
in material and workmanship, shall not be adulterated or mis-branded as defined
by the Act (or applicable foreign law) and shall not be a product which would
violate any section of such Act if introduced in interstate commerce and
shall be fit for use as a pharmaceutical product.  Acorda agrees not to assert its right to rescind this Agreement
(if any) in the event of a breach of the representations of Elan contained in
this Article 8.6.


 


It
is hereby acknowledged for the avoidance of doubt that for the purposes of this
Article 8, commercial supplies of Product under the Supply Agreement are
not regarded as supplied “under this Agreement”.


 


8.7.                                   Elan and
Acorda is each fully cognisant of all applicable statutes, ordinances and
regulations of the United States of America with respect to the manufacture of
the Product including, but not limited to, the Act and regulations thereunder,
cGLP, cGCP and cGMP.  Elan shall
manufacture or procure the manufacture the Product under this Agreement in
conformity with the Specifications, the relevant portions of the CMC
Section and, if applicable, the DMF and in a manner which fully complies
with all United States of America and foreign statutes, ordinances, regulations
and practices.


 


29

















 


8.8.                                   Acorda
shall indemnify and hold harmless Elan, its agents and employees from and
against all claims, damages, losses, liabilities and expenses to which Elan,
its agents, and employees may become subject related to or arising out of
Acorda’s bad faith, gross negligence or intentional misconduct in connection
with the filing or maintenance of the NDA. 
Elan shall indemnify and hold harmless Acorda, its agents and employees
from and against all claims, damages, losses, liabilities and expenses to which
Acorda, its agents, and employees may become subject related to or arising out
of Elan’s bad faith, gross negligence or intentional misconduct in connection
with the preparation of the CMC Section.


 


8.9.                                   Elan shall
indemnify, defend and hold harmless Acorda and its officers, directors,
employees and agents from all actions, losses, claims, demands, damages, costs
and liabilities (including reasonable attorneys’ fees) due to Third Party
claims to which Acorda is or may become subject insofar as they arise out of or
are alleged or claimed to arise out of (i) any breach by Elan of any of its
obligations under this Agreement, (ii) any breach of a representation or
warranty of Elan made in this Agreement, (iii) any activities conducted by Elan
in connection with the Project, (iv)  any
failure of the Product provided under this Agreement to meet the
Specifications, or (v) the manufacture or shipment of the Product provided
under this Agreement by Elan, except in each case to the extent due to the
negligence or wilful misconduct of Acorda.


 


8.10.                             Acorda
shall indemnify, defend and hold harmless Elan and its officers, directors,
employees and agents from all actions, losses, claims, demands, damages, costs
and liabilities (including reasonable attorneys’ fees) due to Third Party
claims to which Elan is or may become subject insofar as they arise out of or
are alleged or claimed to arise out of (i) any breach by Acorda of any of its
obligations under the Agreement, (ii) any breach of any representation or
warranty of Acorda made in this Agreement, and (iii) any activities conducted
by Acorda in connection with the Project, except to the extent due to the
negligence or wilful misconduct of Elan.


 


8.11.                             Acorda
shall indemnify, defend and hold harmless Elan and its officers, directors,
employees and agents from all actions, losses, claims, demands, damages, costs
and liabilities (including reasonable attorneys’ fees) due to Third Party
claims to which Elan is or may become subject insofar as they arise out of or
are alleged or claimed to arise out of activities conducted by Acorda or its
Designee in the manufacture, transport, packaging, storage, handling,
distribution, promotion, marketing or sale of the Product, that was caused by
the negligence or wrongful acts or omissions on the part of Acorda or its
Designees, except in each case, to the extent covered by Article 8.10 or
due to the negligence or wilful misconduct of Elan.


 


8.12.                             Elan
represents and warrants that, the manufacture, sale, distribution or use of the
Product in the Territory solely because of the use of the Elan Intellectual
Property does not, to Elan’s actual knowledge, infringe any patent owned by a
Third Party, provided, that Elan represents and warrants that it is not aware
of any pending or threatened proceeding or claim of any person or entity
pertaining to the Product, that asserts the infringement of any patent owned by
a Third Party.  In the event that (I) a
claim or proceedings are brought against Acorda and/or Elan by a Third Party alleging
that the


 


30

















 


manufacture,
sale, distribution or use of the Product in the Territory infringes the patent
rights of such Third Party, and such alleged infringement results from the use
of the Elan Intellectual Property, and (II) Elan was in breach of the foregoing
representation and warranty with respect to such Third Party patent rights,
Elan’s liability to Acorda with respect to such infringement pursuant to this
Article 8.12 (including without limitation, reasonable attorney’s fees and
other out of pocket expenses of the litigation, including the fees and expenses
incurred by Elan and Acorda) shall be limited to and shall be borne by the
Parties in the manner set forth in Article 11.3.1.


 


For
purposes of this Article 8, “Elan’s actual knowledge” shall mean the
knowledge of representatives of Elan that have been engaged in the Project in a
key operational role.


 


8.13.                             Elan has
no actual knowledge that (a) the issued and unexpired patents included in the
Elan Patent Rights are invalid or unenforceable over any references or prior
art known to Elan or its agents, taken alone or in combination, nor (b) that
the pending patent applications included in the Elan Patent Rights fail to
include patentable subject matter, nor (c) that Elan and its agents have failed
to comply with any duty of candor imposed on an applicant for patent before a
particular national or regional patent office with respect to the patents,
applications and patent offices listed in Schedule 3.


 


8.14.                             Acorda
represents and warrants that as of the date of this Agreement  to Acorda’s actual knowledge, the
development and manufacture of the Product by Elan or Acorda, or the
manufacture, sale, distribution or use of the Product in the Territory, solely
because of the use of the Acorda Patent Rights or Acorda Know-How will not to
the best of Acorda’s belief infringe any patent owned by a Third Party.


 


For
purposes of this Article 8, “Acorda’s actual knowledge” shall mean the
knowledge of representatives of Acorda that have been engaged in the Project in
a key operational role.


 


8.15.                             As a
condition of obtaining an indemnity in the circumstances set out above, the
Party seeking an indemnity shall:


 


8.15.1                       fully and
promptly notify the other Party of any claim or proceeding, or threatened claim
or proceeding;


 


8.15.2                       permit the
indemnifying Party to take full care and control of such claim or proceeding;


 


8.15.3                       assist in
the investigation and defence of such claim or proceeding;


 


8.15.4                       not
compromise or otherwise settle any such claim or proceeding without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld; and


 


8.15.5                       take all
reasonable steps to mitigate any loss or liability in respect of any such claim
or proceeding.


 


31

















 


8.16.                             TO THE
FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING REPRESENTATIONS,
WARRANTIES AND INDEMNITY, ELAN MAKES NO ADDITIONAL REPRESENTATIONS OR
WARRANTIES AND HEREBY DISCLAIMS ALL WARRANTIES, REPRESENTATIONS, AND
LIABILITIES, WHETHER EXPRESS OR IMPLIED, ARISING FROM CONTRACT OR TORT (EXCEPT
FRAUD), IMPOSED BY STATUTE OR OTHERWISE, RELATING TO THE PRODUCT AND/OR ANY
PATENTS OR TECHNOLOGY USED OR INCLUDED IN THE PRODUCT, INCLUDING ANY WARRANTIES
AS TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR
NON-INFRINGEMENT.


 


8.17.                             EXCEPT IN
RESPECT OF EACH PARTY’S LIABILITY TO INDEMNIFY THE OTHER AGAINST CLAIMS MADE BY
A THIRD PARTY, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN
AND ACORDA SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR
WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE
EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL
OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS
OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF
THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE, EVEN IF ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT THAT THIS LIMITATION SHALL NOT APPLY
TO DAMAGES DIRECTLY OR INDIRECTLY ARISING FROM PERSONAL INJURY OR DEATH CAUSED
BY THE DEFECTIVE DESIGN AND/OR MANUFACTURE OF THE PRODUCT.


 


8.18.                             Elan
represents and warrants that Elan Corporation plc will provide Elan Pharma
Limited or any other subsidiaries with a licence and the rights to manufacture
the Product in accordance with the terms of this Agreement and the Supply
Agreement.


 


ARTICLE 9
[NOT USED]


 


 


ARTICLE 10   COMMITTEE


 


10.1.                             Acorda and
Elan shall establish the Committee to provide oversight, review and
coordination relating to the development, manufacturing and supply, Regulatory
Approval and commercialisation of the Product, and for resolution of disputed
issues that may arise between the Parties under this Agreement or the Supply
Agreement. Unless otherwise agreed, the Committee shall be comprised of six
members, with three members appointed by each of Elan and Acorda.  The operation of the Committee shall be as
set forth at Article 10.2 to Article 10.5.  Acorda and Elan each shall appoint a person (a “Primary Contact”) to be the primary contact
between the Parties with respect to the Project and to coordinate
correspondence and communications between the Parties.  Each Party shall notify the other in writing
within thirty (30) days after the 


 


32

















 


Amendment
Date of its representatives on the Committee and of the  appointment of its Primary Contact and
shall notify the other Party as soon as practicable upon changing its Committee
representatives or the Primary Contact appointment in accordance with
Article 12.12.  The Primary Contact
of each Party will be one of its three representatives in the Committee.


 


10.2.                             Except as
specifically set forth in this Agreement, the Committee shall be responsible
for overseeing the Project, including the following:


 


10.2.1                       reviewing
and, if deemed necessary or desirable, updating the Development Plan, the
Technology Transfer Responsibilities and the Project budget; and accordingly
Elan shall advise the Committee if it believes that the budget for items of the
Project has been or is likely to be significantly exceeded;


 


10.2.2                       facilitating
the transfer of know-how, regulatory correspondence and communications and
other data as contemplated by this Agreement and the Supply Agreement;


 


10.2.3                       reviewing
and assessing the progress of development of Product and, to the extent
contemplated by this Agreement, evaluating and, if determined by the Committee,
approving Technology Transfer Responsibilities and authorizing Elan to perform
tasks required in connection with development of and regulatory submissions
relating to Product;


 


10.2.4                       discussing
objectives for and performance of the Product in the Territory, and the
promotional activities and materials associated therewith;


 


10.2.5                       resolving
any disputes between the Parties relating to the Project, provided, however,
that Acorda shall have the final decision as to all clinical trial protocols
and the conduct of all clinical trials and marketing and promotional activities
by Acorda or its Designee; and


 


10.2.6                       such other
activities as are delegated to the Committee under this Agreement.


 


10.3.                             The
Committee shall use its best efforts to resolve any disputed issues, conflicts
or differences of opinion between the Parties under this Agreement.  If the Committee is unable to reach a
consensus on any issue within thirty (30) days after such issue being presented
to the Committee by a Party, notwithstanding the exercise of its best efforts
as provided in Article 10, then such issue shall be referred to the chief
executive officers of Acorda and Elan Any final decision of the CEOs shall be
conclusive and binding on the Parties hereto, and must be reached, if
practicable under the circumstances, within thirty (30) days after being
referred to the CEO, provided, however, that issues referred to in
Article 10.2.5 as being subject to Acorda’s final decision shall be
determined finally and conclusively by Acorda in the event that the Committee
and/or the CEOs are unable to reach a consensus; provided further, that any
such decision shall comply with applicable governmental regulatory
requirements. Any matter as to which the CEOs are unable to reach agreement may
be submitted by either Party to binding arbitration for final


 


33

















 


resolution
pursuant to Article 12.14, or as
otherwise agreed,  except  with respect to matters for which Acorda
has authority to make final decisions.


 


10.4.                             The
Committee shall consist of the Primary Contact from each Party together with
such additional business and development personnel from each Party who are
deemed necessary to accomplish the work of the Committee.  Unless otherwise agreed, the Committee shall
meet at least once each calendar quarter, in person, or by video or telephone
conference.  In such instance, the next
quarterly meeting will be scheduled. 
Meetings shall be chaired by the chief representative of Acorda and such
representative shall be responsible for preparing minutes of such meetings.


 


10.5.                             At each
meeting, Acorda shall summarize the status of Acorda’s clinical development,
regulatory and, if applicable, marketing and promotional activities with
respect to Product. Any disclosures of such progress, results, data or know-how
in any meeting shall be deemed Confidential Information of Acorda. At and
between meetings of the Committee, each Party shall keep the other fully and
regularly informed as to its progress with its respective obligations.


 


10.6.                             The
Committee shall not be empowered to alter the terms of this Agreement.  The continuation of the Committee shall be
at the discretion of the Parties as deemed appropriate to further the
registration and commercialisation activities in the Territory.


 


ARTICLE 11   PATENTS


 


11.1.


 


11.1.1                       Acorda
shall have the first right to file, prosecute and maintain the Elan Patent
Rights in Elan’s name, using patent counsel selected by Acorda, and shall be
responsible for the payment of all related patent filing, prosecution and maintenance
costs, subject to this Article 11.1.1. 
Upon Acorda’s request, Elan shall reasonably cooperate in the filing,
prosecution or maintenance of any patent application or patent included in the
Elan Patent Rights. If Acorda elects not to file, prosecute or maintain a
patent application or patent included in the Elan Patent Rights in any
particular country, it shall provide Elan with written advance notice
sufficient to avoid any loss or forfeiture, or at least 60 days notice, and
Elan shall have the right, but not the obligation, at its sole expense, to
file, prosecute or maintain such patent application or patent in such country
in Elan’s name. If Elan elects to file, prosecute or maintain a patent or
application within the Elan Patent Rights that Acorda has elected not to file,
prosecute or maintain, such patent or application in such country shall no
longer be deemed an Elan Patent Right for purposes of the license in
Article 2 to Acorda.


 


11.1.2                       Acorda
shall have the first right to file, prosecute and maintain any patent
application(s) or patent(s) arising from Joint Inventions and shall be
responsible for the payment of all related patent prosecution and maintenance
costs.  Upon Acorda’s request, Elan
shall reasonably cooperate in the filing, prosecution or


 


34

















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.


 


maintenance
of any such patent application or patent. 
If Acorda elects not to file, prosecute or maintain any such patent
application or patent in any particular country, it shall provide Elan with
written advance notice sufficient to avoid any loss or forfeiture, or at least
60 days notice, and Elan shall have the right, but not the obligation, at its
sole expense, to file, prosecute or maintain such patent application or patent
in such country. Thereafter, such patent or patent application in such country
shall be deemed solely an Elan Patent Right. In any such case, Acorda shall not
grant any Third Party a license under its interest in the applicable Joint
Invention without the prior written consent of Elan.


 


11.2.                             Acorda and
Elan shall promptly inform the other in writing of any alleged infringement of
which it shall become aware by a Third Party of any patents within the Elan
Patent Rights and provide each other with any available evidence of
infringement. The Parties will thereafter consult and cooperate to determine a
course of action, including, without limitation, the commencement of legal
action by either party.  However, Acorda
shall have the first right to initiate and prosecute such legal action at its
own expense and in the name of Elan and Acorda, or to control the defense of
any declaratory judgment action relating to Elan Patent Rights and Elan will
co-operate with such action at Acorda’s request and expense.  Elan shall receive [*] of any such recovery
remaining after the deduction by Acorda of the reasonable expenses (including
attorney’s fees and expenses) incurred in relation to such an infringement
proceeding.  In the alternative to the
foregoing, the Parties may agree to institute such proceedings in their joint names
and shall reach agreement as to the proportion in which they will share the
proceeds of any such proceedings, and the expense of any costs not recovered,
or the costs or damages payable to the Third Party.  Should Acorda decide not to pursue such infringers within six (6)
months of acquiring knowledge of such infringement, except with respect to
Paragraph IV Certifications, in such case the time of notice shall not exceed
20 days, Elan may do so at its expense provided that Acorda shall receive [*] of
any such recovery remaining after the deduction by Elan of the reasonable
expenses (including attorney’s fees and expenses) incurred in relation to such
an infringement proceeding.  Acorda will
co-operate with such action at Elan’s request and expense.  The Party involved in any such claim, suit
or proceeding, shall keep the other Party hereto reasonably informed of the
progress of any such claim, suit or proceeding. 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.


 


11.3.


 


11.3.1                       In the
event that (I) a claim or proceedings are brought against Acorda and/or Elan by
a Third Party alleging that the manufacture, sale, distribution or use of the
Product in the Territory infringes the patent rights of such Third Party, and
such alleged infringement results from the use of the Elan Intellectual
Property, and (II) as of the date the Specifications for the Product have been
agreed, Elan was or should reasonably have been aware of such Third Party
patent rights, the following shall apply as regards the Third Party claim, including
without


 


35

















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.


 


limitation,
reasonable attorney’s fees and other out of pocket expenses of the litigation,
including the fees and expenses incurred by Elan and Acorda (“Patent Expenses”):


 


11.3.1.1                     if Elan or
its subcontractor is manufacturing the Product, Acorda shall bear the [**] of
Patent Expenses; Elan and Acorda shall bear the remaining Patent Expenses
equally;


 


11.3.1.2                     if Elan or
its subcontractor is not manufacturing the Product, Acorda shall discharge the
Patent Expenses.  Acorda shall be
entitled to credit the Patent Expenses from up to [**] of the royalty otherwise
payable to Elan pursuant to Article 5.6 and may carry forward any such
uncredited Patent Expenses to be credited against up to [**] of the royalty
otherwise payable to Elan pursuant to Article 5.6 until fully expended;
Elan and Acorda shall bear the remaining Patent Expenses equally.


 


During
the term of this Agreement, Acorda shall have the first right but not the
obligation to defend the proceedings referred to in this paragraph and Elan
will co-operate with such action at Acorda’s request and expense.  In such event Acorda shall keep Elan advised
of all material developments in the said proceedings and shall not settle or
compromise such proceedings without the consent of Elan which shall not be
unreasonably withheld or delayed. 
Should Acorda decide not defend such proceedings, Elan may do so and
Acorda will co-operate with such action at Elan’s request and expense.  In such event Elan shall keep Acorda advised
of all material developments in the said proceedings and shall not settle or
compromise such proceedings without the consent of Acorda which shall not be
unreasonably withheld or delayed.


 


Any
sums payable by Elan to Acorda, or by Acorda to Elan pursuant to this Article 11.3.1
shall be discharged by Elan or Acorda, as the case may be, within thirty (30)
days of the appropriate invoice and reasonable supporting documentation being
furnished.


 


11.3.2                       In the
event that a claim or proceedings are brought against Elan and/or Acorda by a
Third Party alleging that the manufacture, sale, distribution or use of the
Product in the Territory as a result of the use of the Elan Patent Rights or
Elan Know-How infringes the patent rights of such a Third Party and Elan should
not reasonably have been aware of such Third Party patent rights, Acorda and
Elan shall meet to discuss in what manner the said proceedings should be
defended and, the manner in which any award for damages, costs and expenses
incurred in respect of or arising out of such a claim or proceedings should be
borne as between Elan and Acorda.


 


11.3.3                       Acorda
shall reasonably consider taking such action as is reasonable, such as, to
re-formulate or modify the applicable Product so as to avoid infringing the


 


36

















 


patent
rights of a Third Party, or entering into a licence agreement with such Third
Party after due consultation with Elan.


 


11.3.4                       Elan shall
have no liability to Acorda whatsoever or howsoever arising for any losses
incurred by Acorda as a result of having to cease selling Product or having to
defer the launch of selling Product, as a result of a court order or settlement
entered into pursuant to Article 11.5.


 


11.4.


 


11.4.1                       In the
event that a claim or proceedings are brought against Elan by a Third Party
alleging that the manufacture, sale, distribution or use of the Product in the
Territory infringes the patent rights of such Third Party, and such alleged
infringement results from the use of the Acorda Patent Rights or Acorda
Know-How, Elan shall promptly advise Acorda of such threat or suit.  Acorda shall indemnify Elan against such a
claim, including without limitation, reasonable attorney’s fees and other
expenses of the litigation, provided however, that as of the date the
Specifications have been agreed, Acorda was or should reasonably have been
aware of such Third Party patent rights; and further provided that Elan shall
not acknowledge to the Third Party or to any other person the validity of the
patent rights of such a Third Party and shall not compromise or settle any
claim or proceedings relating thereto without the written consent of
Acorda.  At its option, Acorda may elect
to take over the conduct of such proceedings from Elan.


 


11.4.2                       In the
event that a claim or proceedings are brought against Elan by a Third Party
alleging that the manufacture, sale, distribution or use of the Product in the
Territory solely as a result of the use of the Acorda Patent Rights or Acorda
Know-How infringes the patent rights of such a Third Party and Acorda should
not reasonably have been aware of such Third Party patent rights, Acorda and
Elan shall meet to discuss in what manner the said proceedings should be
defended and, the manner in which any award for damages, costs and expenses
incurred in respect of or arising out of such a claim or proceedings should be
borne as between Elan and Acorda.


 


11.4.3                       In the
event that a claim or proceedings are brought against Elan by a Third Party
alleging that the manufacture, sale, distribution or use of the Product in the
Territory infringes any patents held by such Third Party and Acorda or its
Designee is manufacturing the Product, and the claim or proceeding results from
the use of the patent rights or know-how of Acorda or its Designee (and not the
Elan Intellectual Property), Elan shall promptly advise Acorda of such threat
or suit.  Acorda shall indemnify Elan
against such a claim, including without limitation, reasonable attorney’s fees
and other expenses of the litigation; provided that Elan shall not acknowledge
to the Third Party or to any other person the validity of the patent rights of
such a Third Party and shall not compromise or settle any claim or proceedings
relating thereto without the written consent of Acorda.  At its option, Acorda may elect to take over
the conduct of such proceedings from Elan.


 


37

















 


11.5.                             In the
event that a claim or proceedings are brought against either Party by a Third
Party alleging that the sale, distribution or use of the Product in the
Territory as a result of the use of the Joint Inventions infringes the patent
rights of such a Third Party, Acorda and Elan shall meet to discuss in what
manner the said proceedings should be defended and the manner in which any
award for damages, costs and expenses incurred in respect of or arising out of
such a claim or proceedings should be borne as between Elan and Acorda,
provided, however, that Acorda shall have the first right to control the defense
of such action relating to Joint Inventions and Elan will co-operate with such
action at Acorda’s request and expense. 
Neither Party shall acknowledge to a Third Party or to any other person
the validity of the patent rights of such a Third Party, the invalidity of the
Elan Patent Rights or the Acorda Patent Rights and shall not compromise or
settle any claim or proceedings relating thereto without the written consent of
the other Party, such consent not to be unreasonably withheld or delayed.  The Parties shall co-operate in relation to
all material aspects of such litigation or other proceedings and shall meet to
discuss in what manner the said proceedings should be defended.  If one Party has control of the litigation
or other proceeding pursuant to the terms of this Agreement and the other Party
wishes to retain separate representation, the latter Party shall bear the costs
of such representation.


 


11.6.                             Acorda
agrees to mark all Product it sells or distributes pursuant to this Agreement
with applicable patent numbers or otherwise in accordance with the applicable
statute or regulations in the country or countries of manufacture and sale
thereof.


 


ARTICLE 12   SUNDRY
CLAUSES


 


12.1.                             Secrecy:


 


12.1.1                       Any
Confidential Information pertaining to the Product that has been or will be
communicated or delivered by Elan to Acorda, and any information from time to
time communicated or delivered by Acorda to Elan, including, without
limitation, trade secrets, business methods, and cost, supplier, manufacturing
and customer information, shall be treated by Acorda and Elan, respectively, as
Confidential Information, and shall not be disclosed or revealed to any Third
Party whatsoever or used in any manner except as expressly provided for herein;
provided, however, that such Confidential Information shall not be subject to
the restrictions and prohibitions set forth in this section to the extent
that such Confidential Information:


 


12.1.1.1                     is
available to the public in public literature or otherwise, or after disclosure
by one Party to the other becomes public knowledge through no default of the
Party receiving such confidential information; or


 


12.1.1.2                     was known
to the Party receiving such confidential information prior to the receipt of
such confidential information by such Party, whether received before or after
the date of this Agreement; or


 


38

















 


12.1.1.3                     is
obtained by the Party receiving such confidential information from a Third
Party not subject to a requirement of confidentiality with respect to such
confidential information; or


 


12.1.1.4                     is
required to be disclosed pursuant to: (A) any order of a court having
jurisdiction and power to order such information to be released or made public;
or (B) any lawful action of a governmental or regulatory agency.


 


12.1.2                       Each Party
shall take all such precautions with Confidential Information disclosed to it
by the other Party as it normally takes with its own confidential information
to prevent any improper disclosure of the Confidential Information disclosed to
it by the other Party to any Third Party; provided, however, that such
confidential information may be disclosed within the limits required to obtain
any authorisation from the FDA or any other United States of America or foreign
governmental or regulatory agency or, with the prior written consent of the
other Party, which shall not be unreasonably withheld, or as may otherwise be
required in connection with the purposes of this Agreement.


 


12.1.3                       Notwithstanding
the above, each Party hereto may use or disclose Confidential Information
disclosed to it by the other Party to the extent such use or disclosure is
reasonably necessary in filing or prosecuting patent applications, prosecuting
or defending litigation, complying with applicable governmental regulations or
otherwise submitting information to tax or other governmental authorities,
conducting clinical trials, or making a permitted sub-licence or otherwise
exercising its rights hereunder, provided that if a Party is required to make
any such disclosure of the other party’s Confidential Information, other than
pursuant to a confidentiality agreement, it will given reasonable advance
notice to the latter Party of such disclosure and, save to the extent
inappropriate in the case of patent applications and regulatory submissions,
will use its best efforts to secure confidential treatment of such information
prior to its disclosure (whether through protective orders or otherwise).


 


12.1.4                       Each Party
agrees that it will not use, directly or indirectly, any Confidential
Information disclosed by the other Party pursuant to this Agreement or the
Supply Agreement, other than as expressly provided herein or in the Supply
Agreement.


 


12.1.5                       Acorda and
Elan will not publicise the existence of this Agreement in any way without the
consent of the other, which consent shall not be unreasonably withheld or
delayed, subject to the disclosure requirements of applicable laws and
regulations; provided, however, that it is understood that the Parties
or their Affiliates may make disclosure of this Agreement and the terms hereof
in any filings required by the SEC, may file this Agreement as an exhibit to
any filing with the SEC and may distribute any such filing in the ordinary
course of its business, provided, further, that to the maximum
extent allowable by SEC rules and regulations, the Parties shall be seek to
maintain the confidentiality


 


39

















 


obligations
set forth herein and shall redact any confidential information set forth in
such filings.  In the event that either
Party wishes to make an announcement concerning the Agreement, that Party shall
seek the consent of the other Party, which consent shall not be unreasonably
withheld or delayed and shall not be required to the extent the text of the
announcement relating to this Agreement has previously been agreed to by the
other Party.  The terms of any such
announcement shall be agreed in good faith.


 


12.2.                             Assignments/
Subcontracting:


 


12.2.1                       Subject to
the provisions of this Article 12.2, each party be entitled without the
consent of the other:


 


12.2.1.1                     to
subcontract or delegate the whole or any part of its duties hereunder to its
Affiliate(s) (but shall remain responsible for its obligations under this
Agreement); and/or


 


12.2.1.2                     to assign
this Agreement to its Affiliate, provided that such assignment has no material
adverse tax implications for the other party or parties hereto, and provided
further that the assigning Party shall remain liable and
responsible with such assignee to the other Party for the performance of any
obligations, representations or warranties delegated, contracted, assigned or
otherwise transferred to any such assignee.


 


12.2.2                       Elan may,
but shall not be obliged to, assign its rights and obligations under this
Agreement to a Permitted Assignee (as such term is defined in the Supply
Agreement) of the Supply Agreement.


 


12.2.3                       Each Party
may assign all (but not a portion) of its rights and obligations under this
Agreement to an entity that acquires all or substantially all of its business
or assets to which this Agreement pertains, whether by merger, reorganisation,
acquisition, sale or otherwise.


 


12.2.4                       Except as
provided for in this Article 12.2, this Agreement may not be assigned by a
party without the prior written consent of the other Party, which shall not be
unreasonably withheld or delayed.


 


12.2.5                       Any
permitted assignee of a Party under this Article 12.2 shall
assume all related obligations of its assignor under this Agreement.


 


12.3.                             Parties
bound:


 


This
Agreement shall be binding upon and enure for the benefit of Parties hereto,
their successors and permitted assigns.


 


40

















 


12.4.                             Severability:


 


If
any provision in this Agreement is agreed by the Parties to be, or is deemed to
be, or becomes invalid, illegal, void or unenforceable under any law that is
applicable hereto, (i) such provision will be deemed amended to conform to
applicable laws so as to be valid and enforceable or, if it cannot be so
amended without materially altering the intention of the Parties, it will be
deleted, with effect from the date of such agreement or such earlier date as
the Parties may agree, and (ii) the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be impaired or affected in
any way.


 


12.5.                             Duration
and Termination:


 


12.5.1


 


12.5.1.1                     Subject to
the other provisions of Article 12.5, this Agreement shall remain in full
force and effect for a period commencing as of the date of this Agreement and
shall expire on a country by country basis on the latest of:


 


(a)          fifteen (15) years starting from the Amendment
Date;


 


(b)         expiry of the last to expire patent included in
the Elan Patent Rights in that country; and


 


(c)          the existence of Competition in that country


 


(the “Initial Period”).


 


12.5.1.2                     At the end
of the Initial Period, the Agreement may be continued for five (5) year terms
by the consent of the Parties, which consent shall not be unreasonably withheld
or delayed.  The Party requiring the
extension shall serve two (2) years written notice on the other prior to the
end of the Initial Period or any additional five (5) year period.


 


12.5.2                       The
Agreement shall be subject to earlier termination in accordance with the
following provisions:


 


12.5.2.1                     Acorda may
terminate this Agreement in its entirety or with respect to any country with
thirty (30) days prior written notice to Elan prior to Regulatory Approval, and
with ninety (90) days prior written notice to Elan at any time thereafter;


 


12.5.2.2                     subject to
the determination in an arbitration that Acorda has breached the applicable
provisions, Elan may terminate the Agreement for the applicable region(s) or
country or countries of the Territory if Acorda breaches the provisions of
Article 2.11.3, or Acorda indicates to Elan pursuant to
Article 2.11.4.3, that it does not intend to obtain Regulatory Approval
and commercialise the Product, and Elan does not exercise its option to take a
licence to the


 


41

















 


Acorda
Patent Rights and the Acorda Know-How in accordance with Article 2.11.3.


 


12.5.3                       In
addition to the rights of early or premature termination provided for elsewhere
in this Agreement, in the event that any of the terms or provisions hereof are
incurably breached by either Party, the non-breaching Party may immediately
terminate this Agreement by written notice. 
An incurable breach shall be committed when either Party is dissolved,
liquidated, discontinued, becomes insolvent, or when any proceeding is filed or
commenced by either Party under bankruptcy, insolvency or debtor relief
laws.  In the event of any other breach,
the non-breaching Party may terminate this Agreement by the giving of written
notice to the breaching Party that this Agreement will terminate on the
sixtieth (60th) day from notice unless cure is sooner effected.  If the breaching Party has proposed a course
of action to rectify the breach and is acting in good faith to rectify same but
has not cured the breach by the sixtieth (60th) day, the said period shall be
extended by such period as is reasonably necessary to permit the breach to be
rectified.


 


12.5.4                       Upon
exercise of those rights of termination as specified in Article 12.5.2, or
Article 12.5.3, in any country or countries or the entire Agreement as the
case may be, this Agreement shall, subject to the other provisions of the
Agreement and Article 12.5.5, automatically terminate forthwith in the
applicable country or countries or the entire Agreement as the case may be, and
be of no further legal force or effect.


 


12.5.5                       Upon
termination of the Agreement:


 


12.5.5.1                     any sums
that were due from Acorda to Elan prior to the exercise of the right to
terminate this Agreement (including but not limited to, Research and
Development Costs and such additional expenses pursuant to Article 5.7 in
each case incurred prior to the notice of termination, shall be paid in full
within sixty (60) days of termination of this Agreement;


 


12.5.5.2                     all confidentiality
provisions set out herein shall remain in full force and effect for a period of
five (5) years;


 


12.5.5.3                     all
representations and warranties shall insofar are appropriate remain in full
force and effect;


 


12.5.5.4                     the rights
of inspection and audit shall continue in force for the period referred to in
the relevant provisions of this Agreement;


 


12.5.5.5                     termination
of this Agreement for any reason shall not release any Party hereto from any
liability which, at the time of such termination, has already accrued to the
other Party or which is attributable to a period prior to such termination nor
preclude either


 


42

















 


Party
from pursuing all rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement;


 


12.5.5.6                     save and
except as is necessary to enable Elan to exercise the licences granted by
Acorda to Elan pursuant to Article 2.9 and Article 2.11.3, upon any
termination of this Agreement, Acorda and Elan shall promptly return to the
other Party all Confidential Information received from the other Party (except
one copy of which may be retained for archival purposes); and


 


12.5.5.7                     in the
event this Agreement is terminated for any reason, Acorda and its Designees
shall have the right for a period of six (6) months from termination to sell or
otherwise dispose of the stock of any Product then on hand, which such sale
shall be subject to the terms of the Supply Agreement.


 


12.5.5.8                     Article 1,
Article 2.2, Article 8, Article 11.1.1, 11.1.2, 11.2, 11.3,
11.4, 11.5, and Article 12 shall survive the termination or expiration of
this Agreement for any reason.


 


12.5.6


 


12.5.6.1                     In the
event of termination of the licences to the Elan Intellectual Property granted by
Elan to Acorda pursuant to Article 2.11.3 as to any country or countries
or in the event of the termination of this Agreement by Elan pursuant to
Article 12.5.3, Acorda shall at the option of Elan grant a licence to the
Acorda Patent Rights and the Acorda Know-How, including the data, information,
Regulatory Applications, Regulatory Approvals, pricing and reimbursement
approvals to enable Elan to commercialise the Products in such country or
countries on the terms set out in Article 2.11.3 and to the Trademark on
the terms set out in Article 2.9.


 


12.6.                             Force
Majeure:


 


Neither
Party to this Agreement shall be liable for delay in the performance of any of
its obligations hereunder if such delay results from causes beyond its
reasonable control, including, without limitation, acts of God, fires, strikes,
acts of war, or intervention of a Government Authority, non availability of raw
materials, but any such delay or failure shall be remedied by such Party as
soon as practicable.


 


12.7.                             Relationship
of the Parties:


 


Nothing
contained in this Agreement is intended or is to be construed to constitute
Elan and Acorda as partners or joint venturers or either Party as an employee
of the other.  Neither Party hereto
shall have any express or implied right or authority to assume or create any
obligations on behalf of or in the name of the other Party or to bind the other
Party to any contract, agreement or undertaking with any Third Party.


 


43

















 


12.8.                             Amendments:


 


No
amendment, modification or addition hereto shall be effective or binding on
either Party unless set forth in writing and executed by a duly authorised
representative of both Parties.


 


12.9.                             Waiver:


 


No
waiver of any right under this Agreement shall be deemed effective unless
contained in a written document signed by the Party charged with such waiver,
and no waiver of any breach or failure to perform shall be deemed to be a
waiver of any future breach or failure to perform or of any other right arising
under this Agreement.


 


12.10.                       No effect
on other agreements:


 


Except
as specifically set forth herein, no provision of this Agreement shall be
construed so as to negate, modify or affect in any way the provisions of any
other agreement between the Parties unless specifically referred to, and solely
to the extent provided, in any such other agreement.


 


12.11.                       Applicable
Law:


 


This
Agreement is construed under and ruled by the laws of the State of New York,
excluding its conflict of laws rules. 
For the purpose of this Agreement the Parties submit to the jurisdiction
of the United States District Court for the State of New York.


 


12.12.                       Notice:


 


12.12.1                 Any notice to be
given under this Agreement shall be sent in writing in English by registered
airmail or faxed to:


 


	
  Elan at

  
	
   

  
	
  c/o Elan International
  Services Ltd.

  
	
  102 St. James Court

  
	
  Flatts,

  
	
  Smiths FL04

  
	
  Bermuda

  
	
   

  
	
  Attention:

  	
   

  	
  Secretary

  
	
  Fax:

  	
   

  	
  +1 441 292 2224

  
	
   

  
	
  Acorda at:

  
	
   

  
	
  Acorda Therapeutics, Inc.

  
	
  15 Skyline Drive

  
	
  Hawthorne, New York 10532

  
	
  United States of America

  
	
  Attention:

  	
   

  	
  Chief Executive Officer

  
	
  Fax :

  	
   

  	
  +1 914.347.4560

  



 


44

















 


or
to such other address (es) and fax numbers as may from time to time be notified
by either Party to the other hereunder.


 


12.12.2                 Any notice sent by
registered air-mail shall be deemed to have been delivered within seven (7)
working days after despatch and any notice sent by fax shall be deemed to have
been delivered within twenty four (24) hours of the time of the despatch.  Notice of change of address shall be
effective upon receipt.


 


12.13.                       No Implied
Rights:


 


No
rights or licences are granted or deemed granted hereunder or in connection
herewith, other than those rights expressly granted in this Agreement.


 


12.14.                       Arbitration:


 


Any dispute
under this Agreement which is not settled by the Committee or the CEOs pursuant
to Article 10 or otherwise by mutual consent shall be finally settled by
binding arbitration, conducted in accordance with the Commercial Arbitration
Rules of the American Arbitration Association by three (3) arbitrators
appointed in accordance with said rules. 
The arbitration shall be held in New York, New York and at least one of
the arbitrators shall be an independent expert in pharmaceutical product
development and marketing (including clinical development and regulatory
affairs).  The arbitrators shall
determine what discovery will be permitted, consistent with the goal of
limiting the cost and time which the Parties must expend for discovery;
provided the arbitrators shall permit such discovery as they deem necessary to
permit an equitable resolution of the dispute. 
Any written evidence originally in a language other than English shall
be submitted in English translation accompanied by the original or a true copy
thereof.  The costs of the arbitration,
including administrative and arbitrators’ fees, shall be shared equally by the
Parties and each Party shall bear its own costs and attorneys’ and witness’
fees incurred in connection with the arbitration.  A disputed performance or suspended performances pending the
resolution of the arbitration must be completed within thirty (30) days
following the final decision of the arbitrators or such other reasonable period
as the arbitrators determine in a written opinion.  The parties shall use all reasonable efforts to ensure that any
arbitration subject to this Article 12.14 shall be completed within one (1) year from the
filing of notice of a request for such arbitration.  The arbitration proceedings and the decision shall not be made
public without the joint consent of the Parties and each Party shall maintain
the confidentiality of such proceedings and decision, subject to any contrary
provision of this Agreement or unless otherwise permitted by the other Party.  The Parties agree that the decision shall be
the sole, exclusive and binding remedy between them regarding any and all
disputes, controversies, claims and counterclaims presented to the
arbitrators.  Application may be made to
any court having jurisdiction over the Party (or its assets) against whom the
decision is rendered for a judicial recognition of the decision and an order of
enforcement.


 


12.15.                       Independent
Development:


 


Expect
as expressly set forth in Article 2.2, nothing in this Agreement will
impair Acorda’s right to independently acquire, license, develop for itself, or
have others develop for it, intellectual


 


45

















 


property
and technology performing similar functions as the Elan Intellectual Property
or to market and distribute products based on such other intellectual property
and technology.


 


12.16.                       Further
Assurances:


 


At
any time or from time to time on and after the date of this Agreement, each
party shall at the request of the other (i) delivery to the other such records,
data or other documents consistent with the provisions of this Agreement, (ii)
execute, and delivery or cause to be delivered, all such consents, documents or
further instruments of transfer or licence, and (iii) take or cause to be taken
all such actions, as such party may reasonably deem necessary or desirable in
order for such party to obtain the full benefits of this Agreement and the
transactions contemplated hereby.


 


12.17.                       Entire
Agreement:


 


This
Agreement including its Appendices, Schedules and Exhibits, together set forth
the entire agreement and understanding of the Parties with respect to the
subject matter hereof, and supersedes all prior discussions, agreements and
writings in relating thereto, including the letter of agreement of 31st
December 1996, the SCI Agreement, the MS Agreement (as assigned and
assumed) and any term sheets or memoranda of understandings relating to any of
the foregoing.


 


12.18.                       Counterparts:


 


This
Agreement may be executed in two counterparts, each of which shall be deemed an
original and which together shall constitute one instrument.


 


***


 


46

















 


IN WITNESS THEREOF the Parties hereto
have executed this Agreement in duplicate.


 


 


	
  SIGNED

  
	
   

  
	
   

  
	
   

  	
   

  
	
   

  
	
  for and on behalf of

  
	
  ELAN
  CORPORATION, PLC.

  
	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  
	
   

  
	
   

  
	
  SIGNED

  
	
   

  
	
   

  
	
   

  	
   

  
	
   

  
	
  for and on behalf of

  
	
  ACORDA
  THERAPEUTICS, INC.

  
	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  
				



 


47

















 


SCHEDULE 1   ACORDA
PATENT RIGHTS


 


GRANTED PATENT


 


	
  Country

  	
   

  	
  Patent
  Number

  	
   

  	
  Grant
  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  US

  	
   

  	
  5,952,357

  	
   

  	
  14-Sept-1999

  	
   

  	
  Issued

  	
   

  	
  Blass, J. et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Title:  TREATING DISEASES OF THE ANTERIOR HORN
  CELLS

  
	
   

  	
   

  	
   

  
	
  US

  	
   

  	
  5,545,648

  	
   

  	
  13-Aug-1996

  	
   

  	
  Issued

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AU

  	
   

  	
  676,251

  	
   

  	
  03-June-1997

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CZ

  	
   

  	
  28441

  	
   

  	
  20-Dec-1993

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  EP

  	
   

  	
  0626848

  	
   

  	
  04-June-2003

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  HU

  	
   

  	
  219583

  	
   

  	
  19-Mar-2001

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  



 


48

















 


	
  KP

  	
   

  	
  31250

  	
   

  	
  25-Aug-1997

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  KR

  	
   

  	
  301415

  	
   

  	
  25-June-2001

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NO

  	
   

  	
  308.644

  	
   

  	
  25-June-2001

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NZ

  	
   

  	
  258844

  	
   

  	
  22-Sept-1997

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  RU

  	
   

  	
  2160590

  	
   

  	
  23-May-2000

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SK

  	
   

  	
  280922

  	
   

  	
  20-Dec-1993

  	
   

  	
  Granted

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  



 


49

















 


PENDING PATENT APPLICATIONS


 


	
  BG

  	
   

  	
  99047

  	
   

  	
  20-Dec-1993

  	
   

  	
  Pending

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CA

  	
   

  	
  2,085,785

  	
   

  	
  20-Dec-1993

  	
   

  	
  Pending

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  JP

  	
   

  	
  6-514637

  	
   

  	
  20-Dec-1993

  	
   

  	
  Pending

  	
   

  	
  Hansebout, R, et al.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

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

  



 


50

















 


SCHEDULE 2   ASSIGNMENT
AGREEMENT


 


The
remainder of this page is intentionally blank. 
The pages of this Schedule are numbered out of sequence.


 


51

















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


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


Commission.


 


 


SCHEDULE 3   ELAN PATENT
RIGHTS


 


	
  1806

  	
   

  	
  Formulations and their use
  in the treatment of neurological diseases

  	
   

  	
  Pending:

  Canada

  Ireland

  Japan

  	
   

  	
  

  2054822

  3952/90

  349324/1991

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Issued:

  Australia

  Europe

  New Zealand

  South Africa

  United States

  	
   

  	
  

  657706

  484186

  240439

  91/8711

  5370879

  5540938

  5580580

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  Pending:

  [***]

  	
   

  	
  

  [***]

  



 


52

















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


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


Commission.


 


 


SCHEDULE 4   NDA
TIMELINE


 


[*******]


 


53

















 


SCHEDULE 5   RUSH/ACORDA
LICENSE


 


The remainder of this page is intentionally blank.  The pages of this Schedule are numbered
out of sequence.


 


54

















 


SCHEDULE 6   RUSH
PAYMENTS AGREEMENT


 


The remainder of this page is intentionally blank.  The pages of this Schedule are numbered
out of sequence.


 


55

















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


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


Commission.


 


 


SCHEDULE 7   SPECIFICATIONS


 


Current
Analytical Methods and Specifications For Finished Product Contained in

the US Drug Master File


 


[****]


 


56

















 


SCHEDULE 8   SUPPLY
AGREEMENT


 


The
remainder of this page is intentionally blank. 
The pages of this Schedule are numbered out of sequence.


 


57

















 


SCHEDULE 9   TECHNOLOGY
TRANSFER RESPONSIBILITES


 


ELAN &
ACORDA RESPONSIBILITIES IN CONNECTION WITH FAMPRIDINE DRUG

PRODUCT TECHNOLOGY TRANSFER TO PATHEON, FAMPRIDINE STABILITY

PROGRAM AT CARDINAL (FORMERLY MAGELLAN) & FOR API

MANUFACTURERS


 


ELAN RESPONSIBILITIES DURING TECHNOLOGY
TRANSFER TO PATHEON


 


•                                     Elan will send to Patheon API,
standards and samples of drug product batches required to successfully transfer
the drug substance and drug product methods


 


•                                     Elan will test and release API lots
for the Patheon technology transfer studies


 


•                                     Elan will send copies to Patheon of
methods, specifications, method validation reports, batch formulae, component
specifications, tablet tooling drawings, and process information as needed, to
initiate method and process technology transfer


 


•                                     Elan will review and approve method
and process technology transfer protocols prepared by Patheon


 


•                                     Elan will approve methods and
process technology transfer reports


 


•                                     Elan will consult with Patheon on
issues as they arise during the method and process technology transfer; if
required, an Elan analyst or process chemist will travel to Patheon to provide
on-site assistance and training on the methods


 


•                                     Elan will review analytical data and
executed batch records generated from Patheon’s technology transfer work in
connection with batch release by Patheon


 


58

















 


ACORDA RESPONSIBILITIES DURING TECHNOLOGY
TRANSFER TO PATHEON


 


•                                     Acorda
will manage Patheon project timelines


 


•                                     Acorda
will provide project management and technology assessment review support during
method and process technology transfer


 


•                                     Acorda
will manage and approve the budget for the Patheon technology transfer work


 


•                                     Acorda
will consult with Patheon on issues as they arise during the method and process
technology transfer; if required, an Acorda representative will travel to
Patheon to participate in technical/project team meetings


 


ELAN RESPONSIBILITIES FOR PATHEON AFTER
SUCCESSFUL TECHNOLOGY TRANSFER


 


•                                     Elan will
provide technical support and guidance to Patheon if technical issues arise


 


•                                     Elan will
perform release testing and regulatory release of API lots for the Patheon
process validation studies if validation occurs prior to NDA approval


 


ACORDA RESPONSIBILITIES FOR PATHEON AFTER
SUCCESSFUL TECHNOLOGY TRANSFER


 


•                                     Acorda
will review batch record and quality control documentation in connection with
regulatory release by Patheon of process validation batches


 


•                                     Acorda
will manage the Patheon project


 


•                                     Acorda
will be responsible for compliance oversight of Patheon


 


59

















 


•                                     Acorda
will review and approve all validation protocols and final reports generated by
Patheon, as needed


 


•                                     Acorda
will review analytical data and batch records generated by Patheon in
connection with regulatory release by Patheon


 


•                                     Acorda
will provide project management and technology assessment oversight and review
support to Patheon


 


•                                     Acorda
will prepare the CTD Quality section for the NDA as it pertains to Patheon


 


ELAN RESPONSIBILITIES FOR CARDINAL (FORMERLY
MAGELLAN) STABILITY PROGRAM


 


•                                     Elan will
review and approve Cardinal stability protocols


 


•                                     Elan will
review data generated from Cardinal’s analytical testing as needed


 


•                                     Elan will
review stability data tables generated from the Cardinal stability studies


 


•                                     Elan will
notify Acorda of any out-of-specification results reported to them by Cardinal
or discovered during the Elan review of stability data


 


•                                     Elan will
consult with Cardinal on issues as they arise during the stability studies; if
required, an Elan analyst will travel to Cardinal to provide on-site assistance
and training on the methods


 


•                                     Elan will
audit Cardinal and will be responsible for compliance oversight during the
Cardinal stability studies


 


•                                     Elan will
participate and provide technical support during product-specific PAI activities
at Cardinal as needed


 


60

















 


ACORDA RESPONSIBILITIES FOR CARDINAL
(FORMERLY MAGELLAN) STABILITY PROGRAM


 


•                                     Acorda
will participate in discussions with Cardinal and Elan on technical and project
management issues


 


•                                     Acorda
will review stability protocols and final stability reports from the Cardinal
studies


 


•                                     Acorda
will manage and approve the budget for the Cardinal stability studies


 


•                                     Acorda
will consult with Cardinal and Elan on issues as they arise during stability
studies; if required, an Acorda representative will travel to Cardinal to
participate in technical/project team meetings


 


•                                     Acorda may
participate in technical meetings with Cardinal and/or compliance audits that
pertain to fampridine stability studies


 


ELAN RESPONSIBILITIES FOR PROCUREMENT OF
FAMPRIDINE API


 


•                                     Elan will
provide technical advice to API manufacturers (Regis and Uetikon)


 


•                                     Elan will
perform regulatory release testing and will release batches for all incoming
lots of API to be used in routine production at Elan and through process
validation at Patheon (if validation takes place prior to NDA approval)


 


•                  Elan will oversee and review process validation
activities at the API manufacturers


 


•                                     Elan will
participate and provide technical support during product-specific PAI
activities at the API manufacturers as needed


 


•                                     Elan will
review API manufacturer’s regulatory documentation in connection with DMF
submission by the API manufacturers in connection with NDA submission


 


•                                     Elan will
notify Acorda of any out-of-specification results reported to them by API
manufacturers


 


•                                     Elan will
be responsible for auditing and assuring cGMP compliance at the API API
manufacturers


 


•                                     Elan will
purchase API and manage supply chain logistics in connection with API to be
used in Elan drug product production


 


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•                                     Elan will
purchase and manage supply chain logistics in connection with API to be used in
Patheon drug product only prior to NDA approval (in connection with technology
transfer work and through process validation if validation occurs before NDA
approval)


 


ACORDA RESPONSIBILITIES FOR PROCUREMENT OF
FAMPRIDINE API


 


•                                     Acorda
will participate in discussions with API manufacturers on technical and project
timeline issues


 


•                                     Acorda
will provide technical review support in connection with preparation of
technical reports, regulatory documentation and validation documentation in
connection with commercial scale-up and process optimization activities at the
API manufacturers


 


•                                     Acorda
will participate in compliance audits of API manufacturers


 


•                                     Acorda
will review and advise Elan on budget matters in connection with API
manufacturing and development


 


•         Acorda will consult with Elan and API
manufacturers on issues as they arise during development; if required, an
Acorda representative will travel to the API manufacturers to participate in
technical/project team meetings


 


•                  Acorda will be responsible for purchasing API
to be used in commercial production of Patheon drug product


 


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