Exhibit 10.9


 


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


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


Commission


 


EXECUTION COPY


 


Date:        September
2003


 


 


ELAN CORPORATION,
PLC.


 


AND


 


ACORDA THERAPEUTICS,
INC.


 


 


SUPPLY AGREEMENT


 


 


Fampridine
SR


 

















 


INDEX


 


	
  CLAUSE 1

  	
  PRELIMINARY

  
	
   

  	
   

  
	
  CLAUSE 2

  	
  EXCLUSIVE SUPPLY

  
	
   

  	
   

  
	
  CLAUSE 3

  	
  REGULATORY MATTERS

  
	
   

  	
   

  
	
  CLAUSE 4

  	
  FORECASTS AND ORDERS

  
	
   

  	
   

  
	
  CLAUSE 5

  	
  SUPPLY OF THE PRODUCT

  
	
   

  	
   

  
	
  CLAUSE 6

  	
  DISPUTES AS TO SPECIFICATION

  
	
   

  	
   

  
	
  CLAUSE 7

  	
  SECOND SOURCE

  
	
   

  	
   

  
	
  CLAUSE 8

  	
  ADVERSE EVENTS AND PRODUCT RECALL

  
	
   

  	
   

  
	
  CLAUSE 9

  	
  FINANCIAL PROVISIONS

  
	
   

  	
   

  
	
  CLAUSE 10

  	
  PAYMENTS, REPORTS AND AUDITS

  
	
   

  	
   

  
	
  CLAUSE 11

  	
  DURATION AND TERMINATION

  
	
   

  	
   

  
	
  CLAUSE 12

  	
  CONSEQUENCES OF TERMINATION

  
	
   

  	
   

  
	
  CLAUSE 13

  	
  REPRESENTATIONS AND WARRANTIES;
  INDEMNIFICATION

  
	
   

  	
   

  
	
  CLAUSE 14

  	
  MISCELLANEOUS PROVISIONS

  
	
   

  	
   

  
	
  SCHEDULE 1

  	
  MANUFACTURING COST

  



 

















 


THIS SUPPLY AGREEMENT is made the
           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)                                   Elan and Acorda have entered into a Licence Agreement concerning the
Product (as each of those terms are defined below).


 


(B)                                     Elan is prepared to manufacture and supply the Product to Acorda for
onward commercial supply.


 


(C)                                     Elan and Acorda are desirous of entering into this Agreement to give
effect to the arrangements described at Recitals (A) and (B).


 


NOW IT IS HEREBY
AGREED AS FOLLOWS:


 


 


CLAUSE 1                  PRELIMINARY


 


1.1.                                   Definitions:


 


“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 or under  common control with Elan or Acorda, as the
case may be.  For the purposes of this
Agreement, “control” shall mean the direct or indirect ownership of more than
50% of the issued voting 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 supply agreement (which expression shall be deemed to include
the Recitals and Schedules hereto).


 


1

















 


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


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


Commission


 


“Batch”
shall mean a specific quantity of Product that is produced according to a
single manufacturing order during the same cycle of manufacture, which quantity
shall be agreed in the Technical Agreement.


 


“cGMP”  shall
mean current Good Manufacturing Practice as defined in the Act and FDA guidance
documents; or as applicable current Good Manufacturing Practice under
applicable regulations in the European Union.


 


“EEA”
shall mean the countries comprising the European Economic Area, as the same may
change from time to time.


 


“Effective
Date” shall mean the date of this Agreement.


 


“Elan’s
Facility” shall mean Monksland, Athlone, Co. Westmeath, Ireland or
such other facility as Elan may use to perform its obligations hereunder and is
in compliance with the NDA and other regulatory requirements.


 


“Elan Territory”
shall mean any country or countries in which Elan, or any licensee of Elan
other than Acorda, is permitted to commercialise the Product, by virtue of
termination of the License Agreement in that country or the grant of a license
by Acorda to Elan pursuant to Article 2.11.3 of the License Agreement.


 


“EXW”
or “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.


 


“Force
Majeure” shall mean any cause or condition beyond the reasonable
control of the party obliged to perform, including acts of God, acts of
government (in particular with respect to the refusal to issue necessary import
or export licenses), fire, flood, earthquake, war, riots or embargoes, strikes
or other labour difficulties affecting a party, or either party’s inability to
obtain supplies of components of the Product howsoever arising.


 


“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 [***] per day.


 


“Governmental
Authority” shall mean the FDA and /or all other governmental and
regulatory bodies, agencies, departments or entities, whether or not located in
the Territory, which regulate, direct or control commercial and other related
activities in or with the Territory.


 


“Launch
Stocks” shall mean the quantities of stocks of the Product required
by Acorda in relation to the launch of the Product following Regulatory
Approval in a Major Market, as more fully described in Clause 4.7.


 


“Launch Year”
shall mean the period commencing on the date of First Commercial Sale and
expiring on the last day of the month that is the twelfth (12th)
month following the


 


2

















 


date in which
the First Commercial Sale occurs. For example, if the First Commercial Sale
occurs on March 15 of any year, the Launch Year shall commence on March 15 of
such year and expire on March 31 of the following year.


 


“Licence
Agreement” shall mean that certain Amended and Restated Licence
Agreement between Elan and Acorda of even date herewith.


 


“Major
Market(s)”  shall mean the US, the UK, France,
Germany, Italy and Japan.


 


“Manufacturing
Cost” shall mean the costs described in Schedule 1 as they relate to
the Product, PROVIDED THAT if Elan is manufacturing the Product for sale in an
Elan Territory, in no event shall Manufacturing Cost exceed Elan’s own costs
for such manufacture, as calculated based on GAAP.


 


“Maximum
Capacity” shall mean Elan’s maximum quarterly manufacturing capacity
for the Product from time to time, as agreed in, or determined pursuant to, the
Technical Agreement.


 


“Minimum Elan
Requirements” shall mean for any Year, at least seventy five percent
(75%) of Acorda’s total requirements of the Product.


 


“Minor
Deficiencies” shall mean shortfalls or delays that are not
inconsistent with industry accepted standards, which standards applicable to
the Product shall be clarified in the Technical Agreement.


 


“Permitted
Elan Assignee” shall mean any entity that purchases all or
substantially all of the assets of Elan’s Facility and has entered into a
written agreement with Elan for the benefit of Acorda whereby (inter alia) it
represents to Acorda that it is (i) reasonably experienced in the field of
pharmaceutical manufacturing (including the existing management of Elan’s
Facility), (ii) in possession of sufficient financial resources and liquidity
to perform the obligations of Elan under this Agreement and (iii) in good
standing with the FDA.


 


A Permitted
Elan Assignee shall also include any entity that has been formed for the
purpose of acquiring Elan’s Facility, and shall, following such acquisition, be
under the management of individuals reasonably experienced in pharmaceutical
manufacturing (including the said existing management), in possession of
sufficient financial resources and liquidity to perform the obligations of Elan
under this Agreement, and none of which are debarred individuals or entities
within the meaning of 21 U.S.C. section 335(a) or (b) and have the capacity of
being in good standing with the FDA.


 


“Product”
shall mean the oral product developed pursuant to the Project, in final
packaged and labelled form for commercial sale or for distribution as
promotional samples and as defined in the approved NDA or NDA Equivalent.


 


“Recall”
means a company’s removal or correction of a marketed Product that the FDA or
equivalent Governmental Authority considers to be in violation of law and
against


 


3

















 


which such
agency might reasonably be expected to initiate legal action (e.g., a seizure).
A Recall does not include market withdrawal for other reasons, or a stock
recovery.


 


“Serious
Failure to Supply” shall mean that in a period of a Year, for
reasons other than Force Majeure or the default of Acorda, Elan fails on at
least two occasions to supply Acorda’s properly forecasted and ordered
requirements of the Product in accordance with the terms of this Agreement,
except for Minor Deficiencies, and the cumulative shortfall for such Year
attributable to such failure(s) is at least 25% of the aggregate amount
properly forecasted and ordered from Elan for delivery in such Year.


 


“Term”
shall mean the term of this Agreement, as set out in Clause 11.


 


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


 


“Year”
means each consecutive four Calendar Quarters.


 


1.2.                                   Further Definitions:


 


In addition, the following definitions have
the meanings in the Clauses corresponding thereto, as set forth below:


 


	
  Definition

  	
   

  	
  Clause

  
	
   

  	
   

  	
   

  
	
  “Discount”

  	
   

  	
  9.4

  
	
  “First Approval”

  	
   

  	
  4.1.1

  
	
  “Manufacturer”

  	
   

  	
  7.1

  
	
  “Resumption Quarter”

  	
   

  	
  7.6.1

  
	
  “Second Source”

  	
   

  	
  7.1

  
	
  “Second Source Quantity”

  	
   

  	
  7.2.1

  
	
  “Supply Price”

  	
   

  	
  9.3.1

  
	
  “Technical Agreement”

  	
   

  	
  5.5

  



 


1.3.                                   Definitions in Licence Agreement:


 


Except as otherwise defined in this
Agreement, all capitalised terms used in this Agreement shall have the same
meaning as in the Licence Agreement.


 


1.4.                                   Interpretation:


 


In this Agreement:


 


1.4.1                             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.


 


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


 


1.4.2                             any reference to a Clause or Schedule, unless otherwise specifically
provided, shall be respectively to a Clause or Schedule of this Agreement.


 


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


 


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


 


 


CLAUSE 2                  EXCLUSIVE SUPPLY


 


2.1.                                   Subject to the terms and conditions of this Agreement, during the
Term, Acorda shall purchase its Minimum Elan Requirements of the Product in the
Territory from Elan, except as provided in Clause 2.3.


 


2.2.                                   Subject to the terms and conditions of this Agreement, during the
Term, Elan shall not supply the Product to:


 


2.2.1                             any person other than Acorda outside the Elan Territory; or


 


2.2.2                             any person other than Acorda in the Elan Territory who intends, to
the actual knowledge of Elan, to sell the Product outside the Elan Territory –


 


except
as requested by Acorda, PROVIDED THAT to extent required by
applicable law, Elan shall be permitted to:


 


(a)                                       sell the Product to a person in a country which is both part of the
Elan Territory and within the EEA, notwithstanding that such person may re-sell
the Product in another part of the EEA which is not part of the Elan Territory;
and


 


(b)                                      if any country of the EEA is part of the Elan Territory, sell the
Product to a person in another country of the EEA which is not part of the Elan
Territory, provided further that Elan shall not actively solicit any such
sales.


 


2.3.                                   Elan shall not have the obligation to use commercially reasonable
efforts to supply the Product where [***] of Manufacturing Cost would exceed
the Supply Price, subject to Clauses 2.4 and 2.5


 


2.4.                                   In the event that either party is of the opinion that the circumstances
in Clause 2.3 apply or may shortly apply, it shall promptly notify the
other.  In such event the parties shall
meet to discuss, inter alia, the manner in which Manufacturing Cost is
calculated by Elan and Acorda’s commercialisation plans.


 


2.5.                                   If after such discussions Elan is of the opinion that if it
continues to supply the Product to Acorda, the circumstances in Clause 2.3 will
apply, Elan shall promptly formally so notify Acorda.  In such event


 


5

















 


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


 


2.5.1                             Elan shall use commercially reasonable efforts to supply Acorda with
Product the subject of binding orders issued prior to Acorda’s receipt of such
notification, provided that such orders relate to Product scheduled for
delivery in the period of three (3) months after the date of the purchase
orders, and that such Product shall be invoiced at the applicable price under
Clause 9.2 or 9.3; and


 


2.5.2                             After the expiration of the period referred to in Clause 2.5.1,
Acorda shall have no further obligation to purchase Product under this
Agreement, provide, however, that Acorda may at its option place further
purchase orders for delivery during up to a six (6) month period immediately
following the period referred to in Clause 2.5.1, subject always to Clause
4 and Clause 5, provided, further, that (i) any such purchase orders are placed
not later than three (3) months from the date of Elan’s notice under this
Clause 2.5; and (ii) any such Product ordered shall be invoiced at a price
equal to Manufacturing Cost plus [**].


 


If following
the period referred to in Clause 2.5.2, Acorda wishes to continue to purchase
the Product from Elan and Elan is prepared to supply the same, the Parties
shall negotiate in good faith the terms of any such supply and purchase.


 


As from the
time of Elan’s notice, Acorda shall be entitled to purchase the Product from
the Second Source, but without prejudice to binding purchase orders already
placed with Elan and subject to the foregoing paragraph.


 


 


CLAUSE 3                  REGULATORY MATTERS


 


3.1.                                   Elan shall be responsible, at Elan’s expense, for filing for and
maintaining all license and permits pertinent to Elan’s Facility, as distinct
from the Regulatory Approvals specific to the Product, without prejudice to
Elan’s responsibilities under the Licence Agreement in respect of preparation
and delivery to Acorda for incorporation into the NDA or any NDA Equivalent, of
the CMC Section.


 


3.2.                                   Upon Elan’s prior written notice, Acorda shall permit Elan or any
Affiliate to have access to the NDA and any NDA Equivalent and Regulatory Approvals
and to take photocopies of same, as required by Elan to fulfil reporting
requirements or as otherwise may reasonably be required by Elan in connection
with this Agreement.


 


3.3.                                   Inspections or Inquiries by Governmental Authorities. With respect to Product supplied by it, Elan shall be responsible
for all process and equipment validation and quality control tests and
procedures required by any Governmental Authority and shall take all steps
necessary to pass inspection by any Governmental Authorities in the Major
Markets, but without prejudice to Article 6.3 of the License Agreement. Elan
shall:


 


3.3.1                             notify Acorda as soon as possible, but in any event within the time
period to be set forth in the Technical Agreement, of any notification received
by Elan from a Governmental Authority to conduct an inspection of its
manufacturing or other


 


6

















 


facilities
used in the development, manufacturing, packaging, storage or handling of the
Product;


 


3.3.2                             without delay make available to Acorda a copy of any inspection
report received by Elan resulting from any inspection of any of such facilities
by such Governmental Authority to the extent such report relates to Product,
the formulation, manufacture, testing, storage and delivery of the Product or
any premises used by Elan in performing Elan’s obligations under this
Agreement;


 


3.3.3                             provide Acorda with a written copy of any proposed response(s)
thereto at least three Business Days prior to submitting such response to any
Governmental Authority as well as a copy of the response actually submitted.


 


Representatives
of Acorda or its Designee shall have the right to be present during the
inspection and/or during the close-out session with the inspectors.  Any Form 483 observations or warning letter
related to the Product shall be provided promptly to Acorda, which shall have
the right to review and discuss the proposed written response to such 483
observations or warning letter, and a copy of the response actually submitted
shall be promptly provided to Acorda. Copies of all other correspondence with
any Governmental Authority relating to that any party’s  activities under this Agreement will be
provided to the other party within forty-eight (48) hours.


 


3.4.                                   Inspection by Acorda / Governmental Authority.  Elan shall make (i) any
licenses and permits relating to Elan’s Facility; and (ii) that portion of
Elan’s facility where the Product is manufactured, packaged, tested or stored,
including all record and reference samples, available for inspection:


 


3.4.1                             by Acorda’s duly qualified employee or Designee
or, with the consent of Elan, by Acorda’s agent or contractor; or


 


3.4.2                             by the relevant Governmental Authority.


 


An inspection under Clause 3.4.1 shall be limited to determining
whether there is compliance with cGMP and other requirements of applicable law,
including production or quality issues relating
to the Product.  Any consent required under this Clause 3.4
shall not be unreasonably withheld or delayed.


 


3.5.                                   Preservation Samples/Retained Samples.  Pursuant to all applicable laws, rules and
regulations and to the Specifications, Elan shall assign and apply lot numbers
and shall take from each lot of (i) the API used to manufacture Product
pursuant to this Agreement; (ii) inactive ingredients used in the manufacture
of Product pursuant to this Agreement; and (iii) the Product shipped to Acorda
or its designee pursuant to this Agreement, preservation samples/retained
samples. Elan shall retain and store the particular lot of API, other
ingredients or Product, as applicable, in accordance with FDA and other
applicable regulations, which currently provide for a period expiring no
earlier than two years after the expiration of the shelf life of the particular
lot of Product shipped to Acorda or its Designee pursuant to this
Agreement.  Preservation
samples/retained


 


7

















 


samples, as
referred to herein, do not include samples retained for purposes of stability
testing.


 


3.6.                                   Elan shall at its option be entitled to change the manufacturing
process or site for manufacture of the Product, provided that (a) Elan provides
Acorda with all required information in form and substance necessary to file
any related amendments or supplements to the NDA or any NDA Equivalent or, if
applicable, Elan files with applicable regulatory authorities any required
amendments or supplements to any DMF; (b) no such change shall take effect
until all requisite regulatory approvals have been obtained, and (c) Elan shall
be responsible for the costs associated with such change.  Acorda shall reasonably co-operate with Elan
in obtaining any such changes requested.


 


 


CLAUSE 4                  FORECASTS AND ORDERS


 


4.1.                                   Forecasts.  Acorda shall provide Elan with bona fide
written forecasts of its estimated Minimum Elan Requirements of the Product as
follows:


 


4.1.1                             within eighteen (18) months prior to the anticipated date of first
Regulatory Approval in any Major Market (“First Approval”), Acorda shall provide Elan
with an eighteen (18) month forecast, broken down on a quarterly basis, for the
period beginning with the anticipated date of First Commercial Sale in such
Major Market (which date shall be specified in the forecast);


 


4.1.2                             thereafter, every three months until First Approval, Acorda shall
provide Elan with an updated forecast on a quarterly basis;


 


4.1.3                             within thirty (30) days of First Approval, and thereafter each
calendar month not later than the 23rd of the month, a rolling 18
month forecast, broken down on a month-by-month and country-by-country basis,
for the period commencing at the beginning of the following month; and


 


4.1.4                             not later than 1 August in each year, a five (5) year forecast,
broken down on an annual basis.


 


Except as
otherwise provided herein, all forecasts made hereunder shall be made to assist
Elan in planning its production and Acorda in planning marketing and sales,
shall not be binding purchase orders, and shall be without prejudice to
Acorda’s subsequent firm orders for the Product in accordance with the terms of
this agreement. Each forecast provided by Acorda shall supercede any previous
forecast and may be expressed in a reasonable range. After receiving Acorda’s
forecasts, Elan shall notify Acorda within five (5) days if Elan becomes aware
that it will be unable to supply Acorda’s forecasted requirements of Product
and, in such event, the provisions of Clause 4.6 shall be applicable.


 


4.2.                                   Purchase Requirements. Subject to the
agreement between the Parties relating to Launch Stocks under Clause 4.7,
Acorda shall be bound to order one hundred percent


 


8

















 


(100%) of the
forecasted quantities of the Product for each month of the first  three (3) months of the most recent rolling
forecast referred to in Clause 4.1.3, but otherwise forecasts shall not be
binding.


 


4.3.                                   Forecasts and orders shall not increase or decrease by more than 25%
in the aggregate amount of Product required in a calendar quarter compared to
the previous calendar quarter, except for Launch Stocks or unless otherwise
agreed by Elan.  However, Elan shall use
reasonable efforts to fulfil Acorda’s requirements in excess of duly forecasted
and ordered amounts.


 


4.4.                                   Forecasts and orders shall not exceed the Maximum Capacity during
the applicable quarterly period.


 


4.5.                                   Firm Orders.  Acorda or its Designee shall provide Elan
with purchase orders on the standard purchase order forms of Acorda or its
Designee (without prejudice to Clause 5.4) of its Elan Minimum Requirements at
least ninety (90) days before it requires each delivery of Product (subject to
Clause 4.7 with respect to Launch Stocks), specifying the required delivery
date in each purchase order and specifying the quantity of Product requested
for commercial use and the quantity of Product for promotional and sample use.


 


4.6.                                   Shortages.  Elan agrees that it will use commercially
reasonable efforts to prevent an interruption of supply to Acorda and shall
immediately notify Acorda of any problems or unusual production situations which
may adversely affect production or quality of Product or its Specifications or
its timely delivery to Acorda or its designee. 
If, at any time during the term of this Agreement, Elan becomes aware
that it will not be able to satisfy Acorda’s forecasts or ordered requirements
for Product, then Elan shall:  (i) give
Acorda prompt notice thereof, (ii) take all commercially reasonable steps to
enable Acorda to procure adequate quantities of Product from the Second Source
in accordance with the applicable provisions of Clause 7 and (iii) if such
inability is partial, Elan shall fulfill firm orders with such quantities of
Product as are available. and shall continue to use its commercially reasonable
efforts to fulfill orders on a timely basis.


 


4.7.                                   Launch Stocks.
Within six months prior to an anticipated Regulatory Approval in a Major
Market, the parties shall discuss and agree upon the manufacture and purchase
of specific quantities of Launch Stocks for launch of the Product in  the applicable Major Market.


 


4.7.1                             Launch Stocks shall be ordered not later than 20 Business Days from
receipt by Acorda of an approval letter, from the FDA or equivalent
Governmental Authority in respect of the NDA or an NDA Equivalent in another
Major Market.


 


4.7.2                             Acorda may use the validation batches of the Product as Launch
Stocks, subject to compliance with applicable laws, the Licence Agreement and
other provisions of this Agreement, provided that in such event, any amounts
previously paid by


 


9

















 


Acorda to Elan
for such validation batches shall be credited against the applicable price for
Launch Stocks under Clause 9.1.


 


 


CLAUSE 5                  SUPPLY OF THE PRODUCT


 


5.1.                                   Save as otherwise provided in this Agreement, Elan shall use
commercially reasonable efforts to produce and supply to Acorda its entire Elan
Minimum Requirements of the Product as set forth in and in response to firm
purchase orders, within ninety (90) days of the purchase order, or one hundred
and fifty (150) days for Launch Stocks or samples (subject to any required
extension due to the lead times of specific components of samples).


 


5.2.                                   Elan shall have no obligation to supply Product:


 


5.2.1                             For any period, in excess of Acorda’s properly forecast requirements
for such period (but Elan will nevertheless use its commercially reasonable
efforts to fulfil Acorda’s requirements in excess of such amounts, having
regard to its manufacturing capacity);


 


5.2.2                             for less than a minimum order of one Batch, or such other minimum
quantity as may be agreed in the Technical Agreement;


 


5.2.3                             in partial Batches;


 


5.2.4                             where Clause 2.3 applies; or


 


5.2.5                             pursuant to an order which does not conform in all material respects
to the provisions of Clause 4 and this Clause 5; provided that if Elan does
supply pursuant to such an order in its absolute discretion, that fulfilment
shall not affect Elan’s right to refuse to fulfil any subsequent order which
does not comply in all material respects with those provisions.


 


5.3.                                   The Product supplied by Elan to Acorda shall:


 


5.3.1                             be delivered in finished packaged form in the dosages and
configurations as set forth in the Specifications and agreed by the parties and
included in the NDA and any NDA Equivalent;


 


5.3.2                             be shipped EXW Elan’s Facility;


 


5.3.3                             be delivered with a certificate of analysis and certificate of
release in respect of the Product, in a form reasonably acceptable to Acorda
(and Acorda shall be entitled to rely upon such certificate of analysis without
the necessity of performing additional testing), in accordance with the terms
of the Technical Agreement, cGMPs and the NDA or any NDA Equivalent; and


 


10

















 


5.3.4                             have a shelf life to be determined in the Technical Agreement.


 


5.4.                                   The terms of this Agreement are hereby incorporated by reference
into each order of Product submitted by Acorda and accepted by Elan.  In the event of any conflict between an
order or other written instructions and this Agreement, the terms of this
Agreement shall prevail.


 


5.5.                                   Not less than eighteen (18) months before the anticipated First
Approval, or such later date as may be determined by the Committee, the parties
shall negotiate in good faith to conclude a detailed technical agreement (the “Technical
Agreement”) regulating the parties’ respective obligations from a
technical and quality perspective for the supply of the Product by Elan to
Acorda, subject in all cases to compliance with cGMPs, the requirements and  commitments
of the NDA and any NDA Equivalent and any other applicable laws or regulations
governing manufacture and supply of Product. 
Such agreement will include commercially reasonable terms as to:


 


5.5.1                             the precise procedures regulating the alleged failure of any
shipment of the Product to conform to the Specifications as a result of an
alleged latent defect and the procedures to be adopted for the return and
replacement of such Product;


 


5.5.2                             the inspection and testing for compliance with specifications of API
to be conducted by Elan prior to incorporation into Product, the testing and
quality analysis of Product to be conducted by Elan prior to shipment of the
Product and the format of the certificate of analysis and certificate of
release to be furnished by Elan to Acorda as well as any quality analysis to be
conducted by Acorda or its Designee;


 


5.5.3                             the batch manufacturing records and other documentation to be
prepared and maintained by Elan and delivered with each shipment to Acorda to
show compliance with cGMP as well as other applicable United States of America
and foreign laws and regulations;


 


5.5.4                             the agreed shelf life of the Product as of the date of shipment;


 


5.5.5                             the quantity of Product constituting a Batch and minimum Batch size
of each shipment of the Product;


 


5.5.6                             the manner in which Elan may provide Acorda with assistance in
relation to field alerts, recalls, complaints and adverse events;


 


5.5.7                             the notification of change by both parties;


 


5.5.8                             the responsibility to collate and write annual product review and
annual reports;


 


5.5.9                             technical agreements with any subcontracted parties;


 


5.5.10                       the stability commitments in NDA or amendments thereto;


 


11

















 


5.5.11                       active drug substance, excipient and component supplier agreements,
including audits/inspections of related manufacturing facilities;


 


5.5.12                       procedures for determining and monitoring the marginal unit variable
element of Manufacturing Cost for purposes of Clause 9.5.1;


 


5.5.13                       such other matters relating to the manufacturing and supply of
Product, including any amendments to any of the terms of this Agreement, any
matters that this Agreement refers to be included in the Technical Agreement or
any other matters that the Parties may mutually agree to or as may be required
by the NDA or any NDA Equivalent.


 


 


CLAUSE 6                  DISPUTES AS TO SPECIFICATION


 


6.1.                                   All claims for failure of any delivery of the Product to conform to
the Specifications must be made by Acorda in writing within sixty (60)
days  following delivery of Product to
Acorda or its Designee except in the case of latent defects.  Acorda shall promptly upon Elan’s request
provide reasonable details of the alleged non-conformance and supporting
evidence, and shall upon request permit Elan to re-test the Product.  If Elan does not agree with Acorda’s
determination of non-conformance, then Elan shall provide Acorda with a written
notice of such disagreement within twenty (20) days of receipt of the
non-conformance notice (adjusted for any delay in providing appropriate details
or permitting re-testing), responding to Acorda’s claim.  The Parties shall use commercially
reasonable efforts to resolve such disagreement within ten (10) Business Days
of Acorda’s receipt of Elan’s notice of disagreement.


 


6.2.                                   Claims for latent defects, not discovered during the routine testing
protocol (to be agreed in the Technical Agreement) shall be made in accordance
with the Technical Agreement in writing within thirty (30) days of
discovery.  Failure to make timely
claims in the manner to be prescribed in the Technical Agreement shall
constitute acceptance of the delivery.


 


6.3.                                   In the event that the Product supplied by Elan is not in compliance
with the Specifications, or is otherwise adulterated, misbranded or defective,
Elan shall, in addition to any other applicable remedies:


 


6.3.1                             be responsible, at the sole cost and expense of Elan, for
re-analysis, sampling, processing, return, disposal or destruction, including
certification of destruction, of such non-conforming Product; and


 


6.3.2                             at its cost, replace the nonconforming Product with Product meeting
the Specifications as soon as reasonably practicable.


 


6.4.                                   In the event that the nonconformity was due to a fault of Acorda,
then, according to Elan’s orders, the Product shall either be destroyed by Acorda,
or returned to Elan for


 


12

















 


destruction
by Elan, at Acorda’s expense.  In such
an event Acorda will not be entitled to any credit as to the non-conforming
Product.


 


6.5.                                   In the event of an unresolved dispute as to:


 


6.5.1                             conformity of the Product with Specifications; or


 


6.5.2                             whether defects in the Product are attributable to the negligent
acts or omissions of Elan,


 


the parties
shall within 30 days after expiration of the ten (10) Business Day period
referred to in Clause 6.1 appoint an independent laboratory to undertake the
relevant testing and its findings shall be conclusive and binding upon the
parties.


 


All costs
relating to this process shall be borne solely by the party whose testing was
in error.


 


If the parties
are unable to agree as to the independent laboratory to be used, the matter
shall be referred to arbitration in accordance with Article 12.14 of the
License Agreement.


 


 


CLAUSE 7                  SECOND SOURCE


 


7.1.                                   Process Transfer to Second Source:


 


Acorda shall be entitled to qualify  the facility of Patheon Inc. at 2100 Syntex
Court, Mississauga, Ontario as a second source of the Product (“Second
Source”), subject to Patheon, Inc. (the “Manufacturer”) undertaking to
Elan to protect the confidentiality of Elan’s manufacturing processes related
to Product and not use them for any other purpose, in terms reasonably
satisfactory to Elan provided that Elan hereby acknowledges that the
Manufacturer is in the process of being qualified as a Second Source
Manufacturer.


 


At Acorda’s request, Elan shall use
commercially reasonable efforts to assist in qualifying the Second Source as an
alternative site of manufacture of the Product.  Pursuant to this obligation, Elan shall:


 


7.1.1                             provide Acorda or the Manufacturer (at Acorda’s request) with any
information necessary to manufacture the Product;


 


7.1.2                             provide to Acorda or the Manufacturer (at Acorda’s request) the
documentation constituting the required material support, more particularly
practical performance advice, shop practice, specifications as to materials to
be used and control methods;


 


7.1.3                             assist Acorda and/or the Manufacturer (at Acorda’s request) with the
working up and use of the technology and with the training of Manufacturer’s
personnel to


 


13

















 


the extent
which may reasonably be necessary in relation to the manufacture of the Product
by the Manufacturer.  In this regard,
Elan will receive the Acorda’s and/or Manufacturer’s scientific staff, as applicable,
in its premises for certain periods, the term of which will be agreed by the
parties; and


 


7.1.4                             comply with the other obligations and responsibilities of Elan
relating to technology transfer to Patheon, as set forth in the Technology
Transfer Responsibilities Schedule.


 


Acorda shall comply with its obligations and
responsibilities relating to technology transfer to Patheon, as set forth in
the Technology Transfer Responsibilities Schedule.


 


7.2.                                   Supply of Product from Second Source:


 


Acorda may purchase the following quantities
of Product from the Second Source and, accordingly, if so purchased, Acorda
shall have no obligation to purchase such quantities from Elan and Elan shall
have no obligation to supply such quantities to Acorda:


 


7.2.1                             In any Year, up to twenty five percent (25%) of Acorda’s total
requirements of Product for such Year, subject to Clauses 7.3.2 and 9.5 (the “Second
Source Quantity”);


 


7.2.2                             quantities of the Product which Elan is not obligated to, and
declines to, supply pursuant to Clause 2.3;


 


7.2.3                             quantities of Product in addition to the Second Source Quantity
required to make up any portion of a valid purchase order which is either (i)
not delivered by Elan by its due date for delivery (regardless of the cause of
late or short delivery), except for Minor Deficiencies, or (ii) by reason of
Force Majeure, to the extent not capable of being delivered by its due date for
delivery, for so long as the Force Majeure continues;


 


7.2.4                             where there is a Serious Failure To Supply, its entire requirements
of the Product, subject to Clause 7.6.


 


7.3.                                   Notification of Supply from Second Source; Equitable Purchase of
Samples:


 


7.3.1                             If Acorda purchases Product from the Second Source, the amount of
the same, together with the quantity so purchased as samples, shall be notified
to Elan in the applicable Statement.


 


7.3.2                             Acorda shall purchase from the Second Source at least the same
proportion of samples of the Product  to
commercial supply of Product as the proportion of samples to commercial supply
purchased by Acorda from Elan.


 


14

















 


7.4.                                   No Supply Restrictions On Second Source:


 


Acorda shall not place or attempt to place
any restriction on supply from the Second Source to Elan or its licensees for
sale in the Elan Territory, except to the extent of the restrictions on supply
by Elan under Clause 2.2.  In
particular, Acorda shall not place or attempt to place any restriction on
supplies from the Second Source to Elan for sale in the Elan Territory or its
licensees after the end of the Term.


 


7.5.                                   Responsibility for Second Source:


 


Assuming compliance by Elan with Clause 7.1,
Acorda shall be solely responsible for:


 


7.5.1                             all process and equipment validation in the Second Source required
by applicable law or regulations and shall take all steps reasonably necessary
to pass inspection by the Governmental Authority;


 


7.5.2                             Product supplied to Acorda or its Designees by the Second Source.


 


7.6.                                   Resumption of Elan Supply:


 


7.6.1                             In the event that Product is being purchased from a Second Source as
a result of Serious Failure To Supply, at such time as Elan has remedied the
situation that caused it and is once again able to fulfil its obligations to
supply Product pursuant to the terms and conditions of this Agreement, Elan
shall so notify Acorda.  Commencing on
the first calendar quarter beginning after the date of such notice (the “Resumption
Quarter”), Acorda shall resume purchasing and Elan shall resume its
obligations to supply the Minimum Elan Quantities from Elan, subject to the
provisions of Clause 7.6.2.


 


7.6.2                             Acorda shall be entitled to:


 


7.6.2.1                        honor its binding purchase commitments from the Second Source,
incurred reasonably and consistently with its practice of ordering from Elan
and for delivery within three (3) months of the date of such commitments, prior
to the notice referred to in Clause 7.6.1; and


 


7.6.2.2                        subsequent to the commencement of the Resumption Quarter, in
addition to the Second Source Quantity, purchase from the Second Source up to
twenty five percent (25%) of Minimum Elan Requirements, to the exclusion of
Elan, for two consecutive calendar quarters in order to be satisfied of Elan’s
ability to fulfil its obligations in respect of the supply of Product pursuant
to the terms and conditions of this Agreement.


 


7.6.3                             The Technical Agreement shall contain terms applicable to the
resumption of supply where the cessation is by reason of Force Majeure, which
shall be not less favourable to Elan than the provisions of Clauses 7.6.1 and
7.6.2 applicable to resumption following Serious Failure to Supply.


 


15

















 


7.7.                                   No Termination Right:


 


Absent Elan’s failure to use commercially
reasonable efforts to supply Product in accordance with the terms of this
Agreement, Acorda shall have no right to terminate this Agreement by reason of
failure to supply, except as otherwise expressly provided herein.


 


7.8.                                   Have Made License:


 


The Parties acknowledge and confirm that:


 


(a)                                  to the extent that Acorda is permitted hereunder to purchase the
Product from Patheon; and


 


(b)                                 following termination of this Agreement, and until termination of
the License Agreement –


 


Acorda is regarded for the purposes of
Article 2.1 of the License Agreement as being permitted to have the Product
made by Patheon at the Second Source (subject always to the terms and
conditions of this Agreement) and that the license grant under such Article 2.1
to make and have made Product extends accordingly.


 


 


CLAUSE 8                  ADVERSE EVENTS AND PRODUCT RECALL


 


8.1.                                   Each party shall give the other prompt notice, which shall be
promptly confirmed in writing, of any occurrence that involves:


 


8.1.1                             any material complaint about the safety or effectiveness of a
Product, including a claim for death or injury following administration of such
Product (that is plausibly related to the administration of such Product); and


 


8.1.2                             any other matter arising out of this Agreement that must be reported
to a Governmental Authority.


 


In the case of
Acorda reporting to Elan matters described in Clause 8.1.2, reporting
quarterly, or in such other timescale as may be agreed in the Technical
Agreement, shall be considered “prompt”.


 


For the
avoidance of doubt, Acorda shall have overall responsibility for adverse event
reporting and medical complaints.


 


8.2.                                   If a party:


 


8.2.1                             is notified by a Governmental Authority that a Recall of a Product
is required, requested or otherwise advisable as being probably needed; or


 


8.2.2                             establishes a need to Recall a Product for non-conformities with the
Specifications –


 


16

















 


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


 


it shall
promptly give to the other party written notice of the same with full details.


 


8.3.                                   Unless otherwise agreed, after consultation with Elan, Acorda shall
take the lead role in any Recall, market withdrawal, stock recovery or any
other corrective action related to Product in a commercially reasonable manner
and Elan shall afford all reasonable assistance.  A final report shall be completed by Acorda and delivered
promptly to Elan.


 


8.4.                                   If the Recall, market withdrawal, stock recovery or other corrective
action relating to a Product arises from Elan’s negligent acts or omissions in
manufacturing the Product, or failure of the Product to conform to
Specifications, the costs, including the cost of replacement quantities of
Products, of such Recall, market withdrawal, stock recovery or other corrective
action relating to a Product shall be borne by Elan provided that Acorda could
not have discovered the said act(s) or omission(s) prior to the sale of the
Product by exercising reasonable diligence. 
In all other circumstances, such costs shall be borne by Acorda. For
purposes of this Agreement, such costs shall include the expenses of
notification and destruction or return of the Recalled Product and all other
documented out-of-pocket costs incurred in connection with such Recall, market
withdrawal, stock recovery or other corrective action relating to a Product,
but shall not include lost profits or opportunity costs of either Party.


 


In the event
that Elan should bear the costs of any recall hereunder, Elan shall be entitled
but not obliged to take over and perform the recall of the Product and Acorda
shall provide Elan at no cost with all such reasonable assistance as may be
required by Elan.


 


 


CLAUSE 9                  FINANCIAL PROVISIONS


 


9.1.                                   Price of Launch Stocks:


 


Elan shall invoice Acorda for Launch Stocks
at a price equivalent to Manufacturing Cost plus [**], subject to
reconciliation pursuant to Clause 9.3.3.


 


9.2.                                   Price of Samples:


 


The price to be charged to Acorda for Product
intended for distribution as free-of-charge promotional samples in its
marketing and promotion of the Product shall be equivalent to Manufacturing
Cost plus [***] which price shall apply to Product supplied EXW Elan’s Facility
to Acorda.  For the avoidance of doubt,
the Parties confirm that if Acorda requires the samples to be supplied in
sample packaging, Manufacturing Cost shall include all costs referable to such
packaging.


 


9.3.                                   Price of Product (General):


 


9.3.1                             Except for Product referred to in Clauses 9.1 and 9.2, the price of
the Product manufactured by Elan to be charged to Acorda under this Agreement
shall be equivalent to [***] of the NSP as determined by the provisions of
Clause 9.3.3 (the “Supply Price”), less the Discount to the
extent applicable, and


 


17

















 


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


 


subject to
Clause 2.5. The
foregoing price shall apply to Product supplied EXW
Elan’s Facility packaged and labelled in final market form and consistent with
the NDA.


 


9.3.2                             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 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 Clause 9.3.3.


 


9.3.3                             Upon supply, Elan shall render an invoice in respect of the
quantities of Product delivered to Acorda for a sum calculated by reference to
[***] of then-applicable Notional NSP. 
The Parties shall adjust their account as of the end of each calendar
quarter during such calendar year by Acorda paying to Elan, or by Elan
crediting Acorda (as the case may be), the difference between the sum paid
pursuant to the previous sentence and the actual Supply Price calculated each
calendar quarter pursuant by reference to actual NSP in such quarter, within
the period specified in Clause 9.6.


 


9.4.                                   Discount:


 


Where Acorda purchases from Elan for delivery
in any Year more than [***] tablets of the Product, Acorda shall be entitled to
a discount (the “Discount”) in respect of the excess equal to [***] of Elan’s
Manufacturing Cost for such excess tablets.


 


The Discount is without prejudice to Clause 2.3.


 


9.5.                                   Compensating Payment:


 


9.5.1                             In respect of all Product purchased from the Second Source pursuant
to Clause 7.2.1 and 7.6.2.2, Acorda shall make a compensating
payment to Elan calculated per unit as X – Y, where “X” is the unit price that
would have applied if the Product were purchased from Elan, under Clause 9.2 or
9.3 as applicable; and “Y” is the marginal unit variable element of Elan’s
Manufacturing Cost applicable to such Product.


 


9.5.2                             Such compensating payment shall be made in respect of a particular
quarter at the time of provision of the Statement, based on the then Notional
NSP and estimated Manufacturing Cost. 
The Parties shall adjust their account as of the end of each calendar
year by Acorda paying to Elan, or by Elan crediting Acorda (as the case may
be), the difference between the sum paid pursuant to Clause 9.5.1 and the
actual payment calculated on the basis of actual applicable NSP and actual
Manufacturing Cost calculated at the end of the calendar year, or such other
period as may be specified in the Technical Agreementwithin sixty (60) days
after the end of the calendar year.


 


18

















 


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


 


9.6.                                   Time For Payment:


 


For the first two years following First
Commercial Sale of the Product in any country of the Territory, payment for the
Product supplied to Acorda shall be effected in $ within sixty (60) days of the
date of the relevant invoice issued on supply by Elan pursuant to Clause
9.3.3.  Thereafter, payment shall be
effected by Acorda in $ within thirty (30) days of the date of the relevant
invoice issued on supply by Elan pursuant to Clause 9.3.3.


 


The adjusting payments referred to in Clause
9.3.3 shall be made on provision of the relevant Statement.


 


For the avoidance of doubt, in respect of
Product ordered for a particular country prior to Regulatory Approval in that
country, Acorda shall be responsible for the price of such Product as from its
readiness for delivery, notwithstanding that applicable law or regulations may
prevent such Product from being supplied before Regulatory Approval.


 


9.7.                                   Process Transfer Costs:


 


Except as otherwise set forth in this
Agreement, in respect of the establishment, qualification and operation of the
Second Source, Acorda shall be solely responsible for:


 


9.7.1                             Acorda’s own costs and expenses;


 


9.7.2                             all third party costs and expenses, including out of pocket expenses
incurred by Elan, for products or services previously approved by the
Committee; and


 


9.7.3                             work conducted by Elan, its Affiliates, and their employees and
consultants, under the Technology Transfer Responsibilities schedule, or as may
otherwise be agreed to by the Parties, at the rate of FTE plus [***].


 


9.8.                                   VAT:


 


All prices for the Product and other amounts
in this Agreement are exclusive of any applicable value added or any other
sales tax, for which Acorda will be additionally liable, if payable, subject to
Clause 10.


 


 


CLAUSE 10           PAYMENTS, REPORTS AND AUDITS


 


Article 5.9 of the Licence Agreement is
hereby incorporated by reference herein as if restated in its entirety herein.


 


 


CLAUSE 11           DURATION AND TERMINATION


 


11.1.                             This Agreement shall be deemed to have come into force on the
Effective Date and will expire upon expiry or termination of the Licence
Agreement, howsoever arising.


 


19

















 


11.2.                             In addition to the rights of termination provided for elsewhere in
this Agreement, either party will be entitled forthwith to terminate this
Agreement by written notice to the other party if:


 


11.2.1                       that other party commits any breach of any of the provisions of this
Agreement or the Licence Agreement, and in the case of a breach capable of
cure, fails to cure the same within 60 days after receipt of a written notice
giving full particulars of the breach and requiring it to be remedied;
provided, that if the breaching party has proposed a course of action to cure
the breach and is acting in good faith to cure same but has not cured the
breach by the 60th day, such period shall be extended by such period as is
reasonably necessary to permit the breach to be cured, provided that such
period shall not be extended by more than 90 days, unless otherwise agreed in
writing by the parties;


 


11.2.2                       that other party goes into liquidation (except for the purposes of
amalgamation or reconstruction and in such manner that the company resulting
therefrom effectively agrees to be bound by or assume the obligations imposed
on that other party under this Agreement);


 


11.2.3                       an encumbrancer takes possession or a receiver is appointed over any
of the property or assets of that other party;


 


11.2.4                       any proceedings are filed or commenced by that other party under
bankruptcy, insolvency or debtor relief laws or anything analogous to any of
the foregoing under the laws of any jurisdiction occurs in relation to that
other party.


 


11.3.                             For the purposes of Clause 11.2, a breach will be considered capable
of cure if the party in breach can comply with the provision in question in all
respects other than as to the time of performance (provided that time of
performance is not of the essence).


 


11.4.                             Elan may terminate this Agreement by giving twelve (12) months’
written notice to do so to Acorda.


 


 


CLAUSE 12           CONSEQUENCES OF TERMINATION


 


12.1.                             Upon exercise of those rights of termination specified in Clause 11
or elsewhere in this Agreement, this Agreement shall, subject to the provisions
of the Agreement which survive the termination of the Agreement and Clause 12.2
automatically terminate forthwith and be of no further legal force or effect,
provided, however, that if the Agreement is terminated by Elan under Clause
11.4 such termination shall not be effective until the expiration of such
twelve (12) month period


 


12.2.                             Upon termination of this Agreement by either party, the following
shall be the consequences:


 


20

















 


12.2.1                       any sums that were due from Acorda to Elan under the provisions of
Clause 9 or otherwise prior to the exercise of the right to terminate this
Agreement as set forth herein shall be paid in full forthwith provided,
that Elan has delivered Product in accordance with the Specifications and
cGMP;  and Elan shall not be liable to
repay to Acorda any amount of money paid or payable by Acorda to Elan up to the
date of the termination of this Agreement;


 


12.2.2                       all confidentiality provisions set out herein shall remain in full
force and effect for a period of 7 years from the date of termination of this
Agreement;


 


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


 


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


 


12.2.5                       if Elan terminates the Agreement under Clause 11.4, Acorda shall be
entitled to purchase all of Acorda’s requirements of Product from the Second
Source as from termination becoming effective.


 


 


CLAUSE 13           REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION


 


13.1.                             The following clauses of the License Agreement are hereby
incorporated by reference herein as if stated herein in their entirety, except
that for purposes of this Agreement, all references in such clauses to “the
Agreement” or “this Agreement” shall be deemed to mean this Supply Agreement:
Articles 8.2, 8.3, 8.4, 8.5, and 8.7.


 


13.2.                             Elan represents and warrants that the Product supplied to Acorda by
Elan under this Agreement shall be free of any lien, security, interest or
other encumbrance on title, conform to the Specifications and all applicable
laws and regulations and requirements of the FDA and other Governmental
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 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 in the event of a breach of the representations
of Elan contained in this Clause 13.2.


 


13.3.                             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 failure of


 


21

















 


the Product
provided under this Agreement to meet the Specifications, or (iv) 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.


 


13.4.                             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 this Agreement, (ii) any breach of any
representation or warranty of Acorda made in this Agreement, (iii) damages for
personal injury (including death) and/or for costs of medical treatment, caused
by or attributed to the Product, or (iv) the acts or omissions of any
sub-licensee appointed pursuant to the Licence Agreement, except in each case
to the extent due to the negligence or wilful misconduct of Elan or to the
relative extent that Elan is obliged to indemnify Acorda pursuant to Clause
13.3.


 


13.5.                             The party seeking an indemnity shall:


 


13.5.1                       fully and promptly notify the other party of any claim or
proceedings, or threatened claim or proceedings;


 


13.5.2                       permit the indemnifying party to take full control of such claim or
proceedings, with counsel of the indemnifying party’s choice, provided that the
indemnifying party shall reasonably and regularly consult with the indemnified
party in relation to the progress and status of such claim or proceedings;


 


13.5.3                       co-operate in the investigation and defence of such claim or
proceedings; and


 


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


 


The
indemnifying party may settle a Claim on terms which provide only for monetary
relief and do not include any admission of liability.  Save as aforesaid, neither the indemnifying party nor the party
to be indemnified shall acknowledge the validity of, compromise or otherwise
settle any Claim or proceedings without the prior written consent of the other,
which shall not be unreasonably withheld.


 


13.6.                             TO THE FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING
REPRESENTATIONS, WARRANTIES, COVENANTS AND INDEMNITIES, AND THOSE SET FORTH IN
THE LICENSE AGREEMENT 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 PRODUCTS AND/OR ANY PATENTS OR TECHNOLOGY USED OR
INCLUDED IN THE PRODUCTS, INCLUDING ANY WARRANTIES AS


 


22

















 


TO
MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR
NON-INFRINGEMENT.


 


13.7.                             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.


 


13.8.                             Elan and Acorda shall each maintain comprehensive general liability
insurance, insuring against all liability, including product liability,
personal injury, physical injury and property damage in respective  amounts deemed reasonable in the industry
for companies of their respective size and engaged in their respective
activities under this Agreement for the duration of this Agreement and for a
period of 5 years thereafter.


 


Each party
shall provide the other party with a certificate from the insurance company
verifying the above and shall notify the other party in writing at least 30
days prior to the expiration or termination of such coverage.


 


 


CLAUSE 14           MISCELLANEOUS PROVISIONS


 


14.1.                             Secrecy and Confidentiality.  Article 12.1 of the License Agreement is
hereby incorporated by reference herein as if stated herein in its entirety.


 


14.2.                             Licence to Elan:


 


Acorda hereby grants to Elan and
Elan hereby accepts for the Term a non-exclusive royalty-free license to use
such Acorda Patent Rights and Acorda Know-How as are necessary or useful for
the purpose of manufacturing the Product. 
Such rights shall be sub-licensable by Elan to its Affiliates and
sub-contractors, for the sole purpose of manufacturing the Product in
accordance with this Agreement.


 


14.3.                             Assignment:


 


14.3.1                       Subject to the provisions of this Clause 14.3, each party be
entitled without the consent of the other:


 


14.3.1.1              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


 


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14.3.1.2                     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.


 


14.3.2                       In the event that Elan agrees to sell all or substantially all of
the assets of Elan’s Facility, Elan shall so notify Acorda.  In such event, Elan may (a) terminate this
Agreement by ninety (90) days’ written notice to Acorda; or (b) assign all (but
not, subject to the following sentences, a portion) of its rights and
obligations under this Agreement to a Permitted Elan Assignee, provided that
such transfer or assignment has no adverse tax implications for Acorda.


 


14.3.3                       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, provided, that in the
case of an assignment by Elan, the assignee is a Permitted Elan Assignee.


 


14.3.4                       Except as provided for in this Clause 14.3, 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.


 


14.3.5                       Any permitted assignee of a Party under this Clause 14.3 shall
assume all related obligations of its assignor under this Agreement.


 


14.4.                             Parties bound:


 


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


 


14.5.                             Severability:


 


If any provision in this Agreement is deemed
to be, or becomes invalid, illegal, void or unenforceable under applicable
laws:


 


14.5.1                       such provision will be deemed amended to conform to applicable laws
so as to be valid and enforceable; or


 


14.5.2                       if it cannot be so amended without materially altering the intention
of the parties, it will be deleted the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be impaired or affected in
any way.


 


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14.6.           
Force Majeure:


 


14.6.1                       Neither party to this Agreement shall be liable for delay or failure
in the performance of any of its obligations hereunder if such delay or failure
results from Force Majeure.


 


14.6.2                       If Force Majeure prevents or delays the performance by a party of
any obligation under this Agreement, then the party claiming Force Majeure
shall promptly notify the other party thereof in writing.  The parties shall thereafter as soon as
practicable discuss how best to continue their operations in accordance with
this Agreement and shall thereafter continue such discussions on a regular
basis while Force Majeure continues.


 


14.6.3                       Where a party claims Force Majeure, the other party’s obligations
under this Agreement shall be suspended for the period while Force Majeure
continues, but only to the extent reasonably required by the Force Majeure.


 


14.6.4                       The party claiming Force Majeure shall use all reasonable efforts to
avoid, minimise or remove the cause of such non-performance and to mitigate its
effects and shall continue performance with due dispatch whenever such causes
are removed.


 


14.6.5                       Where Force Majeure continues for a period of six (6) months the
other party shall have the right to terminate this Agreement, provided that it
has complied with its obligations under this Clause 14.6.


 


14.7.                             Relationship of the parties:


 


14.7.1                       Nothing contained in this Agreement is intended or is to be
construed to constitute any of the parties hereto as partners or members of a
joint venture or any party as an employee of another party.


 


14.7.2                       No 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 any other
party or to bind another party to any contract, agreement or undertaking with
any third party.


 


14.8.                             Amendments:


 


No amendment, modification or addition hereto
shall be effective or binding on any party hereto unless set forth in writing
and executed by a duly authorised representative of all parties hereto.


 


14.9.                             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.


 


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14.10.                  Entire Agreement:


 


14.10.1                 Each
of the parties hereto hereby acknowledges that in entering into this Agreement
it has not relied on any representation or warranty except as expressly set
forth herein or in the License Agreement or in any other document referred to
herein.


 


14.10.2                 This
Agreement and the Licence Agreement, together with the exhibits and schedules
hereto and thereto, together set forth all of the agreements and understandings
between the parties with respect to the subject matter hereof, and supersede
and terminate all prior agreements and understandings between the parties with
respect to the subject matter hereof, including the SCI Agreement and the MS
Agreement.


 


14.10.3                 Nothing
in this Clause 14.10 shall exclude any liability which any party would
otherwise have to the other party or any right which either of them may have to
rescind this Agreement for fraud.


 


14.11.                       Governing law and jurisdiction:


 


14.11.1                 This
Agreement shall be governed by and construed in accordance with the laws of the
State of New York, excluding its conflict of laws rules.


 


14.11.2                 Article
12.14 of the License Agreement is hereby incorporated by reference herein as if
stated herein in its entirety.


 


14.12.                       Notices:


 


14.12.1                 Any
notice to be given under this Agreement shall be sent in writing in English by
registered or recorded delivery post, reputable overnight courier or fax to:


 


	
  Elan at

  
	
   

  
	
  c/o Elan Pharma Ltd.

  
	
  Monksland

  
	
  Athlone

  
	
  Co. Westmeath

  
	
  Ireland

  
	
  Attention:

  	
  General Manager

  
	
  Fax:

  	
  +353 906 492427

  
	
   

  
	
  Acorda at

  
	
   

  
	
  15 Skyline Drive

  
	
  Hawthorne, New York 10532

  
	
  United States of America

  
	
  Attention:

  	
  President

  
	
  Fax:

  	
  914.347.4560

  



 


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


 


14.12.2                 Any
notice sent by mail shall be deemed to have been delivered within 7 working
days after despatch or delivery to the relevant courier and any notice sent by
fax shall be deemed to have been delivered upon confirmation of receipt.  Notice of change of address shall be
effective upon receipt.


 


14.13.                       Further assurances:


 


At the request of any of the parties, the
other party or parties shall (and shall use reasonable efforts to procure that
any other necessary third parties shall) execute and do all such documents,
acts and things as may reasonably be required subsequent to the signing of this
Agreement for assuring to or vesting in the requesting party the full benefit
of the terms hereof.


 


14.14.                       Counterparts:


 


This Agreement may be executed in any number
of counterparts, each of which when so executed shall be deemed to be an
original and all of which when taken together shall constitute this Agreement.


 


14.15.                       Set-off:


 


Each of the parties will be entitled but not
obliged to set-off against any amount of money payable to it by the other party
hereunder, any amount of money payable by it to the other party hereunder.


 


IN WITNESS WHEREOF the
parties have executed this Agreement on the day and date appearing at the top
of page 1.


 


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SCHEDULE 1  MANUFACTURING COST


 


“Manufacturing
Cost” shall mean fully absorbed cost of manufacture (including packaging) which
shall be determined on the basis of the following elements:


 


(a)                        Direct material, labour and overhead
cost; and


 


(b)                       Such indirect labour, factory,
laboratory and other overhead costs properly allocable.  Overhead allocations shall include, but not
be limited to, expenses of plant maintenance and engineering, plant management,
receiving and warehousing, disposal and treatment of waste, building occupancy,
quality control, costs of services provided to manufacturing and insurance
provided to manufacturing.


 


Such allocations shall be in a manner
consistent with GAAP from time to time and in a manner consistent with expenses
and overhead allocated to other products manufactured by Elan or its
Affiliates.


 


Where some part(s) of the manufacture or
packaging is/are conducted by unaffiliated third party(ies), Manufacturing Cost
shall be the amount paid to such third party(ies) plus any of the
aforementioned costs incurred by Elan or its Affiliates in completing the
manufacture, packaging or delivery of the Product.


 


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  SIGNED

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
  for and on behalf of

  	
   

  
	
  ELAN CORPORATION, PLC.

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  SIGNED

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
  for and on behalf of

  	
   

  
	
  ACORDA THERAPEUTICS, INC.

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
					



 


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