Exhibit 10.21

 

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 Securities and Exchange
Commission.

 

Execution Copy

 

ELAN PHARMA INTERNATIONAL LIMITED

 

AND

 

ACORDA THERAPEUTICS, INC.

 

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DEVELOPMENT AND SUPPLEMENTAL AGREEMENT
TO AMENDED AND RESTATED LICENSE
AGREEMENT

DATED 26 SEPTEMBER 2003 AS AMENDED AND
SUPPLY AGREEMENT DATED 26 SEPTEMBER 2003

 

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Fampridine QD formulation

 

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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 Securities and Exchange
Commission.

 

1.

Definitions and Interpretation

1

 

 

 

2.

Effect on Existing Agreements

3

 

 

 

3.

Development and Project Management (Development Product)

4

 

 

 

4.

Non-Elan Development Product

5

 

 

 

5.

Manufacture and Supply of Pre-Commercial Batches

6

 

 

 

6.

Registration

6

 

 

 

7.

Additional Financial Provisions

7

 

 

 

8.

Application of License Agreement

8

 

 

 

9.

Development Product Supply Agreement

9

 

 

 

10.

Non-Elan Development Product Supply Option

9

 

 

 

11.

Term and Termination

10

 

 

 

12.

Warranties

12

 

 

 

13.

Confidentiality

12

 

 

 

14.

Assignment

12

 

 

 

15.

General

13

 

 

Schedule 1

[*****]

17

Schedule 2

Work Plan Format

18

Schedule 3

Selection Criteria

19

 

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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 Securities and Exchange
Commission.

 

This Development and Supplemental Agreement (“Agreement”) is dated 14th day of
January 2011 (the “Effective Date”). 

 

PARTIES:

 

(1)                                 ELAN PHARMA INTERNATIONAL LIMITED, with an
address at Monksland, Athlone, Co. Westmeath, Ireland (“Elan”) and

 

(2)                                 ACORDA THERAPEUTICS, INC., a Delaware
corporation with an office at 15 Skyline Drive, Hawthorne, NY 10532, USA
(“Acorda”)

 

BACKGROUND:

 

(A)                               Elan Corporation, plc and Acorda are parties
to (i) an Amended and Restated License Agreement dated 26 September 2003
pursuant to which, inter alia, Elan Corporation plc granted certain licenses
under its intellectual property in respect of mono- and di- aminopyridines (as
amended by Amendment No. 1 defined below, the “License Agreement”) and (ii) a
Supply Agreement dated 26 September 2003 pursuant to which Elan Corporation
agreed to supply Product to Acorda (as amended by Amendment No. 1 defined below,
the “Supply Agreement”).

 

(B)                               Elan is the successor in interest of Elan
Corporation, plc.’s rights and obligations under the above described agreements.

 

(C)                               By an Amendment No. 1 Agreement to the License
Agreement and Supply Agreement and Consent to Sublicense dated 30 June 2009
(“Amendment No. 1”), Elan and Acorda made certain amendments to the said
agreements.  The License Agreement, Supply Agreement, and Amendment No. 1 are
referred to herein as the “License and Supply Agreement.”

 

(D)                               The Parties wish to pursue the development of
one or more new formulations of the Compound and/or Alternate Compounds for
existing and/or new indications and the commercialization of one of these
additional formulations.  The formulations will use Elan technologies upon the
terms and conditions of the License and Supply Agreement and the terms and
conditions set out below and/or third party technologies upon the terms and
conditions set out below and specifically stated as applicable to a formulation
developed using third party technologies.  The Parties also wish to further to
provide for certain clarifications in respect of the application of provisions
of the license and Supply Agreement to formulations using Elan technologies.

 

TERMS:

 

The Parties agree as follows:

 

1.                                                   Definitions and
Interpretation

 

1.1                                            Definitions:

 

In this Agreement the following expressions shall have the following meanings:

 

“Agreement”

 

means this agreement, including its recitals, with the attached Schedules.

 

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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 Securities and Exchange
Commission.

 

“Compound Know-How and First Product Know- How”

 

means the Elan Know-How that is or will be disclosed to Acorda in relation to
the Compound or to the First Product under the License or Supply Agreement.  For
clarity and avoidance of doubt this term shall not include any knowledge,
information, trade secrets, data or expertise which is generated or created by
Elan in any Further Development Plan activities.

 

 

 

“Compound and First Product Know-How License”

 

has the meaning set forth in Clause 4.7.

 

 

 

“Development Product”

 

means the Product developed by Acorda and Elan pursuant to this Agreement, the
Further Development Plan and one or more Work Plans, which Product incorporates
the Development Technology.  “Development Product” does not include the “First
Product” but is a “Product” under the License Agreement.

 

 

 

“Development Product Supply Agreement”

 

has the meaning set forth in Clause 9.

 

 

 

“Development Technology”

 

means the technology which is developed by Elan and/or Acorda pursuant to this
Agreement.

 

 

 

“First Product”

 

means that specific formulation (twice daily) of the Product that is marketed as
of the Effective Date in the United States under the trademark “Ampyrafl”.

 

 

 

“Further Development

 

means the development plan for the Development Product, Plan” which as of the
Effective Date is set out in Schedule 1, as it may be amended by Elan and Acorda
from time to time and set out in any amendment to the Further Development Plan
that may be generated in accordance with Clause 3.2 of this Agreement.

 

 

 

“Non-Elan Developer”

 

means any individual or entity other than Elan (including Acorda).

 

 

 

“Non-Elan Development

 

means a formulation of Compound or an Alternate Product” Compound developed or
to be developed by a Non-Elan Developer to meet the Selection Criteria.  For
clarity, “Non-Elan Development Product” shall not be regarded as a “Product” for
the purposes of the License and Supply Agreement or this Agreement.

 

 

 

“Non-Elan Development Product Supply Agreement”

 

has the meaning set forth in Clause 10.4.1

 

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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 Securities and Exchange
Commission.

 

“Non-Elan Party Election”

 

has the same meaning as that set forth in Clause 10.2.

 

 

 

“Selection Criteria”

 

means the target criteria for the Development Product and for each Non-Elan
Development Product, as specified to Non-Elan Developers and as may be amended
from time to time, which as of the Effective Date are set forth in Schedule 3.

 

 

 

“Work Plan”

 

means each written plan for development of Product agreed upon by Acorda and
Elan, which Work Plan sets forth the goals of the work, allocates the
responsibilities of the parties for conducting the work, timelines, and any
other terms and conditions agreed upon between the parties.  All Work Plans
shall be consecutively numbered and, upon execution by authorized
representatives of the parties, shall be incorporated by reference into this
Agreement.

 

1.2                               Interpretation: In this Agreement:

 

1.2.1                     capitalised expressions not specifically defined in
this Agreement shall have the same meaning as in the License and Supply
Agreement, as applicable;

 

1.2.2                     references to clauses are to clauses of this Agreement
unless stated otherwise; and

 

1.2.3                     this Agreement shall otherwise be interpreted in the
same manner as the License and Supply Agreement.

 

2.                                      Effect on Existing Agreements

 

2.1                               Except as expressly provided herein, the
parties agree and acknowledge that the development, commercialization and
commercial supply of the Development Product shall be governed by the License
Agreement, the agreements incorporated by reference in the License Agreement,
the Development Product Supply Agreement and in each case any amendments thereto
(including but not limited to Amendment No 1).  For clarity, the Development
Plan does not apply to the Development Product or the Non-Elan Development
Product.

 

2.2                               For the purposes of clarity, the License
Agreement as amended, the agreements incorporated by reference in the License
Agreement, Supply Agreement and Amendment No. 1 shall continue to govern the
development, commercialization and commercial supply of the First Product.  For
clarity and avoidance of doubt, the Parties hereby acknowledge that the consent
granted by Elan to Acorda in Section 1of the Amendment No. 1 is not modified by
this Agreement.

 

2.3                               At appropriate times during the Term, Elan and
Acorda agree that they will discuss in good faith any clarifications as may be
required to any operational provisions in the License and Supply Agreement to
support the development, commercialization and commercial supply of any
Development Product.  Any such clarifications shall be set forth in an amendment
to this Agreement (or other written, duly executed Elan/Acorda agreements),
executed by authorized representatives of Acorda and Elan.  The Parties agree
that to the extent this Agreement specifically states that certain provisions of
the License Agreement and the Supply Agreement apply to Non-Elan Development
Product, any capitalized terms used within the License Agreement and Supply
Agreement as so referenced shall have the meaning set forth in the License
Agreement or the Supply Agreement, as the case may be, unless this

 

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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 Securities and Exchange
Commission.

 

Agreement specifically states otherwise.

 

3.                                      Development and Project Management
(Development Product)

 

3.1                               Without prejudice to Acorda’s rights to cease
development of the Development Product at any time, throughout the Term and in
accordance with the Further Development Plan and the applicable Work Plan(s),
Elan and Acorda shall use commercially reasonable efforts to develop Development
Product in accordance with the Further Development Plan(s).  For the purpose of
clarity, Acorda, in its sole discretion, may choose to cease development of the
Development Product in the event that Acorda determines that continuing such
development is no longer commensurate with the achievement of its own business
aims.  The decision not to further develop, if made by Acorda, shall not be
subject to review by the Committee nor shall it be subject to arbitration under
Section 12.14 of the License Agreement.

 

3.2                               The Further Development Plan and the
applicable Work Plan(s) set forth the agreed respective responsibilities of Elan
and Acorda with respect to the development of the Development Product.  Without
prejudice to Acorda’s right to cease development at any time during the term of
the Further Development Plan, Elan and Acorda shall undertake their respective
obligations under the Further Development Plan and the applicable Work
Plan(s) on a collaborative basis and using commercially reasonable efforts. 
Changes may be made to the Further Development Plan by mutual, written agreement
of the parties through the Committee referenced in Section 10 of the License
Agreement, which written agreement shall be set forth in an amendment to the
Further Development Plan and/or Work Plan, as applicable.

 

3.3                               Detailed development work shall be agreed and
set out by the parties in one or more Work Plans, which shall be in a form
broadly similar to the Work Plan format attached hereto as Schedule 2.  Each
Work Plan must be mutually agreed by both parties and accepted and signed by a
duly authorized representative of both parties.  Executed Work Plans shall form
a part of this Agreement.

 

3.4                               Within two (2) weeks of the Effective Date of
this Agreement, the parties will establish a project team (“Project Team”),
which shall convene regularly to keep the parties fully informed as to their
progress with its respective tasks and obligations under the Further Development
Plan and Work Plan(s).  The Project Team shall monitor the progress of such
activities.

 

3.5                               Elan and Acorda shall update each other at
meetings of the Committee as to the progress of their respective obligations
under the Further Development Plan and the Work Plan(s).

 

3.6                               The parties shall co-operate in good faith
through the Project Team and the Committee particularly with respect to unknown
problems and contingencies and shall perform their respective obligations in a
commercially reasonable, diligent and workmanlike manner and in accordance with
all applicable laws, regulations and guidelines.

 

3.7                               Provided that a party uses reasonable
endeavours to meet its obligations under this Agreement, it shall have no
liability to the other as a result of any failure or delay of the Development
Product to achieve any of the goals set out in the Further Development Plan or a
Work Plan(s), nor for any failure of a Development Product to obtain NDA
Approval or Regulatory Approval.

 

4.                                      Non-Elan Development Product

 

4.1                               Acorda shall afford Elan a reasonable
opportunity to develop a formulation meeting the Selection

 

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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 Securities and Exchange
Commission.

 

Criteria, and Elan and Acorda shall reasonably cooperate to enable that
opportunity.  The parties further agree that the entry into this Agreement and
the performance of the Further Development Plan set out in Schedule 1meet this
obligation in respect of Elan being afforded a reasonable opportunity and
provided with the Selection Criteria for the Development Product, as they exist
as of the Effective Date.

 

4.2                               Subject to Clause 4.3, in the event that
Acorda selects to commercialize the formulation of a Non-Elan Developer, Acorda
shall discuss the reasons for its selection with Elan.

 

4.3                               Elan acknowledges and agrees that the final
decision on which formulation to develop and commercialize is within Acorda’s
sole discretion and that such decision is not subject to review or dispute by
Elan through the Committee nor is subject to the arbitration provisions set out
in Section 12.14 of the License Agreement.  Acorda shall promptly disclose any
agreed key financial terms of any commercialization agreement with the Non- Elan
Developer to Elan, which Elan shall maintain as confidential under the
confidentiality provisions of Section 12.1of the License Agreement.

 

4.4                               Subject to the foregoing and to the other
terms and conditions of this Agreement, Acorda shall be entitled, through itself
or any sublicensees, to select and commercialize one Non- Elan Development
Product meeting the Selection Criteria.

 

4.5                               Acorda shall afford Elan a reasonable
opportunity to develop any other formulations containing Compound or Alternate
Compound not covered by this Agreement.  For the avoidance of any doubt, nothing
in this Agreement shall be deemed to constitute (i) Elan’s consent to the
commercialisation of any other subsequent Non-Elan Development Product nor any
Non-Elan Development Product that meets different selection criteria or (ii) a
limitation on Acorda’s existing development rights under Section 12.15 of the
License Agreement.

 

4.6                               Where Acorda elects to commercialize a
Non-Elan Development Product, Acorda and Elan shall generally coordinate and
manage their business relationship relating to the commercialization of the
Non-Elan Development Product through the Committee that is referred to in
Article 10 of the License Agreement.  The Committee shall also resolve any
disputed issues (excluding any issues which may arise over Acorda’s formulation
selection under Clause 4.3 or ceasing to develop or not developing Development
Product under Clause 3.1) that may arise between the Parties per Section 10.3 of
the License Agreement including submission to arbitration under Article 12.14. 
Through the Committee, Acorda shall keep Elan reasonably informed of those
matters relating to the Non-Elan Development Product which reasonably affect
Elan’s interests, including the general progress of development, objectives for
and commercial performance of the Non-Elan Development Product, clinical and
regulatory filings, sales performance and sales forecasts and any actual or
threatened litigation or “paragraph IV certifications” pertaining to the
Non-Elan Development Product.

 

4.7                               Elan hereby grants to Acorda a non-exclusive,
non-transferable (other than to a lawful assignee of the License Agreement)
license (the “Compound Know-How and First Product Know-How license”) under the
Compound Know-How and First Product Know-How to develop, package, use, import,
export, make and have made (subject to Clause 10) Non-Elan Development Product
in the Territory and, in addition, to promote, distribute, market, offer for
sale and sell the one particular Non-Elan Development Product (if any) that
Acorda finally selects to commercialize under this Clause 4 in the Territory. 
The part of Compound Know-How and First Product Know-How License that enables
Acorda to promote, distribute, market, offer for sale and sell any finally
selected Non-Elan Development Product shall be sub-licensable to Acorda’s
existing sublicensee without Elan consent and to other sublicensees in
accordance with the terms as set out in Section 2.3 of the License Agreement

 

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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 Securities and Exchange
Commission.

 

for Product; provided that in each case such entitiy is responsible for
commercializing Non-Elan Development Product.  Acorda and any sublicensee it
appoints to commercialize Non-Elan Development Product shall only share Compound
Know-How and First Product Know-How with Non-Elan Developers other than itself
on a strictly need-to know-basis.  This Compound Know-How and First Product
Know-How License shall commence as of the Effective Date and shall end upon the
expiry of Acorda’s obligations to make payments to Elan in respect of the
Non-Elan Development Product, and subject to such payments being duly made shall
be irrevocable during that period.

 

4.8                               For clarity, the foregoing provisions shall
not be construed as conferring any right or license to use any intellectual
property arising from Further Development Plan activities developed solely by
Elan or jointly with Elan in connection with the development, manufacture or
sale of a Non-Elan Development Product, nor as conferring any liability or
obligations on Elan with respect to a Non-Elan Development Product other than as
expressly set out Clause 4.7 and in the Non-Elan Development Product Supply
Agreement and/or other agreement(s) entered into relating to the supply of
Non-Elan Development Product by Elan entered into pursuant to Clause 10 (if
any).

 

5.                                      Manufacture and Supply of Pre-Commercial
Batches of Development Product

 

5.1                               Elan shall use commercially reasonable efforts
to manufacture and supply to Acorda such quantity of the Development Product as
it may reasonably require to perform its activities under the Further
Development Plan and each applicable Work Plan.

 

5.2                               Per Section 3.4 of the License Agreement,
supply of Development Product shall be EXW such facility as may be specified in
the applicable Work Plan or as Elan may nominate and Acorda shall reasonably
approve, [*****].

 

5.3                               Acorda’s requests for Development Product
shall clearly specify whether such use is for pre-clinical or clinical supply. 
Where Acorda requests Development Product for clinical supply, Elan shall
manufacture it in accordance with phase specific cGMPs in addition to applicable
laws and regulations.

 

5.4                               Clauses 13.2 to 13.8 inclusive of the Supply
Agreement (liability) shall apply mutatis mutandis in respect of the supply of
pre-commercial supplies of Development Product.

 

6.                                      Registration ·

 

6.1                               Acorda shall be responsible, at its own
expense, for conducting such pre-clinical and clinical studies as are required
to obtain Regulatory Approval for the Development Product.  Elan shall
reasonably cooperate with Acorda in obtaining such approvals at Acorda’s
expense.

 

6.2                               Elan will prepare and utilize a DMF (or
similar structure for international filings) at Acorda’s expense for the
Development Product and Acorda shall have a right of reference to the extent
required by any regulatory jurisdiction until such time, if any, as Acorda
terminates all development programs related to Non-Elan Development Product. 
Upon receipt of notice of such termination, Elan will discontinue use of the DMF
and promptly provide the relevant CMC information to Acorda in support of
Acorda’s regulatory filing(s), at Acorda’s expense and otherwise in accordance
with the provisions of Section 3.8 of the License Agreement.

 

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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 Securities and Exchange
Commission.

 

7.                                      Additional Financial Provisions

 

7.1                               Development Fees for Development Product. 
Acorda shall pay to Elan fees in respect of Elan’s activities under this
Agreement at a rate of FTE plus [*****], invoiced and payable monthly.  Each
invoice shall identify the particular work requested by Acorda and performed by
Elan under the Work Plan(s) and Further Development Plan(s), as applicable. 
Further, the provisions of Sections 5.1.3 (development records) and 5.1.4 (third
party development costs) of the License Agreement shall apply mutatis mutandis;
provided, however, that in reference to third party development costs Elan shall
have the right to charge Acorda for the time spent by Elan employees in
administering the work conducted by such third parties at [*****] as well as the
third party development costs incurred by Elan.

 

7.2                               Non-Elan Development Product Compensation. 
Notwithstanding any contrary provision of the License Agreement, in
consideration of Elan’s agreement to permit Acorda to commercialize the Non-Elan
Development Product on the terms and conditions herein and in consideration of
the grant of the Compound Know-How and First Product Know-How License, Acorda
shall pay to Elan:

 

7.2.1                     [*];

 

7.2.2                     [*];

 

7.2.3                     [*]; and

 

7.2.4                     [*];

 

in each case as if (a) defined terms [*****] and [*****] referred to the
Non-Elan Development Product instead of the Product and as if (b) the references
in Section 5.3.1of the License Agreement and defined terms used therein to
“Product” additionally referred to the Non-Elan Development Product.

 

7.3                              Application of Rush Payments Agreement.  For
the avoidance of doubt, Acorda shall remain responsible to make payments to Elan
under the Rush Payments Agreement in respect of the Development Product or the
Non-Elan Development Product, as applicable, on the basis that “NSP” as used
therein refers to such products respectively.

 

7.4                           Ancillary.

 

7.4.1                     Section 5.9 of the License Agreement (payments,
reports and records) shall apply in respect of the Non-Elan Development Product
mutatis mutandis.

 

7.4.2                     Payments under Clause 7.2.1 shall be made upon
provision of the Statement;

 

7.4.3                     Payments under Clause 7.2.2 shall be made in
accordance with the applicable supply agreement entered into pursuant to Clause
10, if applicable, and otherwise upon provision of the Statement.

 

7.4.4                     In respect of payments under Clause 7.2.4 [*****],
Sections 5.3.2 to 5.3.5 (payment terms) of the license Agreement shall apply
mutatis mutandis.

 

For clarity and as stated above, the manner and method of payment for Non-Elan
Development Product are identical to the equivalent terms set out for Product
payments in the License Agreement.

 

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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 Securities and Exchange
Commission.

 

8.                                      Application of License Agreement

 

In relation to clarifying the precise manner in which the license Agreement
applies to the Development Product, in addition to specific citations to
sections of the license Agreement herein, Elan and Acorda agree as follows:

 

8.1                               Intellectual Property.  At appropriate times
during the Term and from time to time, Elan and Acorda shall prepare revised
schedules of Elan Patent Rights and Acorda Patent Rights, reflecting such
patents and patent applications as are incorporated and/or used in the
Development Product.

 

8.2                               License Provisions.  For the purpose of
clarification, Elan and Acorda agree that:

 

8.2.1                     the reference in the definition of “Elan Patent
Rights” to the infringement by the manufacture, use or sale of the Product is to
be read as a reference to infringement by the manufacture, use or sale of the
First Product or the Development Product; and

 

8.2.2                     the references in the definition of “Elan Patent
Rights” and “Elan Know How” to development “in connection with the Project” is
to be read as if it additionally referred to development pursuant to this
Agreement.

 

8.3                              Regulatory Expressions.  The definitions of
“NDA”, “NDA Approval”, “Regulatory Approval”, and terms referring to those
defined terms shall be construed as they relate to the First Product or the
Development Product, as applicable.

 

8.4                               Diligence.  Subject to Acorda’s formulation
selection right under Clause 4.3, Section 2.11 (Diligence) of the License
Agreement shall apply in respect of the Non-Elan Development Product mutatis
mutandis.  In performing its obligations under Section 2.11 of the License
Agreement, Acorda shall be entitled to select a commercially reasonable strategy
Development Product or Non-Elan Development Product, as the case may be, on the
other.

 

8.5                               Royalties.  In the event that (a) the
Development Product is being commercially sold and (b) Elan is manufacturing
one, but not both, of the First Product and the commercially sold Development
Product, the Elan Royalty specified in Section 5.6 of the License Agreement
shall be calculated separately for the First Product and the Development
Product.

 

8.6                               Committee.  Article 10 (Committee) of the
License Agreement shall be read as if it additionally referred to the Further
Development Plan and its budget as appropriate.  For clarity, nothing in this
Agreement is intended to expand upon the oversight responsibility of the
Committee with respect to Product as set forth in Article 10 of the License
Agreement.

 

9.                                      Development Product Supply Agreement

 

9.1                               Not less than eighteen (18) months prior to
the anticipated date of commercial launch of the Development Product, Elan and
Acorda shall negotiate in good faith an amendment to the Supply Agreement or a
new substantially similar supply agreement in respect of such Development
Product (“Development Product Supply Agreement”), which Development Product
Supply Agreement shall contain the financial terms set out in this Agreement and
any other provisions of this Agreement that pertain to the Development Product,
together with one or more quality agreements as appropriate.  The decision as to
whether to amend the existing Supply Agreement or to create a substantially
similar supply agreement for Development Product shall be decided by the
Committee.

 

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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 Securities and Exchange
Commission.

 

9.2                               The price of the Development Product
manufactured by Elan under the applicable Development Product Supply Agreement
(or under the applicable amendment to the Supply Agreement) shall [*****]. The
foregoing shall be in lieu of the price stated in Clauses 9.3 and 9.4 of the
Supply Agreement.

 

9.3                               Elan shall enable the use of a mutually agreed
independent second source for manufacture of the Development Product upon terms
substantially similar set out in Clause 7 of the Supply Agreement, as agreed
upon by the Committee and as set out in the Development Product Supply
Agreement.

 

9.4                               Except as set out in this Clause 9, as may be
operationally necessary for the manufacture of a Development Product, or as may
otherwise be agreed by Elan and Acorda in the Development Product Supply
Agreement, the terms of the Development Product Supply Agreement shall be the
same as those set out in the Supply Agreement.

 

10.                               Non-Elan Development Product Supply Option

 

10.1                        In the event that Acorda, chooses to commercialize a
Non-Elan Development Product in accordance with Clause 4.4 of this Agreement,
Elan shall have the first option to manufacture or have manufactured by an
Affiliate all or a portion of the selected Non-Elan Development Product.

 

10.2                        Within forty-five (45) days of the decision to
proceed to commercialization of a Non-Elan Development Product (a “Non-Elan
Party Election”), Acorda shall notify Elan in writing, and shall procure that
Elan is provided within that period with such information as would information
as Elan may reasonably request for the purpose of determining whether it wishes
to undertake such manufacture.  To this end, Acorda shall procure that the
applicable Non-Elan Developer is made available and with Acorda in attendance
and shall cooperate fully to answer queries which Elan may have in this regard,
subject to the terms of a three-way confidential disclosure agreement to be
entered into between Acorda, Elan and the Non-Elan Developer.

 

10.3                        Within ninety (90) days of receipt of all such
requested information, Elan shall notify Acorda in writing whether it is willing
to and believes that it is able to manufacture such Non-Elan Development
Product, and the portion of the Non-Elan Development Product it wishes to
manufacture. If Elan does not so notify Acorda within that period, and to the
extent of the portion which Elan is not willing to or does not believe that it
will be able to manufacture, Acorda shall be entitled (but not obliged) to have
such Non-Elan Development Product manufactured elsewhere.

 

10.4                        In the event that Elan agrees to and is able to
manufacture such Non-Elan Development Product:

 

10.4.1              Elan and Acorda shall negotiate in good faith the terms and
conditions of, and enter into, a supply agreement consistent with this Clause 10
and otherwise with (a) non-financial terms similar to those contained in the
Supply Agreement, to the extent feasible, and (b) the financial terms set out in
Clause 7.2.2 (“Non-Elan Development Product Supply Agreement”); and

 

10.4.2              Elan shall and Acorda shall procure that the Non-Elan
Developer negotiates in good faith a technology transfer agreement and plan for
the purposes of enabling Elan to manufacture the Non-Elan Development Product.
Each party shall be responsible for its own costs of all such activities and
Acorda shall be responsible for any costs or expenses that may be invoiced by
the Non-Elan Developer. Acorda shall be responsible at its own cost for

 

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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 Securities and Exchange
Commission.

 

obtaining for Elan all intellectual property rights and licenses required to
undertake such manufacture.

 

10.5                        Elan shall maintain the right to protect and control
any confidential or proprietary data of Elan as set forth in the License
Agreement or any applicable confidentiality or other agreement which may be
entered into by Elan.

 

11.                               Term and Termination

 

11.1                        This Agreement shall commence on the Effective Date
and shall continue in force until the expiry or termination of the License
Agreement, howsoever arising, unless terminated earlier as set forth herein. 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.  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, at the sole discretion of the non- breaching party, by such period as
is reasonably necessary to permit the breach to be rectified.

 

11.2                        For the avoidance of doubt, termination of this
Agreement pursuant to Clause 11.3 or 11.1 shall not of itself result in
termination of the License Agreement or the Supply Agreement.

 

11.3                        Upon Acorda’s notice to Elan of a Non-Elan Party
Election, Elan’s and Acorda’s obligations in respect of those Work Plans
concerning the Development Product not selected shall automatically terminate,
subject to Clause 11.4 below.

 

11.4                        Upon expiry or termination of this Agreement or upon
the termination of obligations in respect of specific Work Plans, Elan shall
provide Acorda with a timely estimate of any wind down costs and Acorda shall be
responsible for:

 

11.4.1              payment in full for all work conducted by Elan under this
Agreement (and authorized under the Further Development Plan and/or, as
applicable, the specific Work Plans) up to the effective date of termination and
the wind down costs of all terminated Work Plan and Further Development Plan
activities; and

 

11.4.2              all uncancellable out of pocket costs reasonably incurred or
committed prior to the effective date of termination by Elan in contemplation of
the applicable Work Plan(s) and/or terminated Further Development Plan.

 

11.5                        Clause 8 shall remain in force until expiry or
termination of the License Agreement and Clause 3.7 shall remain in force
indefinitely.

 

11.6                        On a country by country basis, in respect of the
Development Product, the following provisions shall continue in force until the
latest of the following dates (the “Development Product End Date”):

 

(a)                                 ten (10) years starting from the date of
First Commercial Sale of the Development Product in that country;

 

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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 Securities and Exchange
Commission.

 

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

 

(c)                                  the date on which no Elan Know-How remains
capable of enforcement against third parties;

 

(d)                                 the loss of regulatory exclusivity in
respect of the Development Product in that country; and

 

(e)                                  the existence of Competition in that
country.

 

the said surviving provisions being: (i) Acorda’s obligations under Sections
5.3, 5.5, 5.6 and 5.9 of the License Agreement; (ii) Acorda’s obligations under
the Rush Payments Agreement; (iii) the equivalent provisions in the applicable
Development Product Supply Agreements to Clause 9.5 of the Supply Agreement, as
if that provision referred to any Development Product purchased up to and
including the Development Product End Date otherwise than pursuant to such
Development Product Supply Agreement; and (iv) Clauses 4, 7.2 to 7.4
inclusive,10, 13,14 and 15 of this Agreement.

 

11.7                        On a country by country basis, in respect of the
Non-Elan Development Product selected for commercialisation, the provisions
referred to below shall continue in force until the latest of the following
dates (the “Non-Elan Product End Date”):

 

(a)                                 ten (10) years starting from the date of
First Commercial Sale (as said term is defined in the License Agreement but in
reference to Non-Elan Development Product rather the Product) of that Non-Elan
Development Product in that country;

 

(b)                                 the expiry of the last to expire patent or
patent application covering such Non-Elan Development Product which Acorda or
any Affiliate or Designee owns, licenses or controls;

 

(c)                                  the date on which no knowledge,
information, trade secrets, data or expertise covering such Non-Elan Development
Product which Acorda or any Affiliate or Designee owns, licenses or controls
remains capable of enforcement against third parties;

 

(d)                                 the loss of regulatory exclusivity in
respect of such Non-Elan Development Product in that country; and

 

(e)                                  the existence of Competition in that
country.

 

the said surviving provisions being Clauses 4, 7.2 to 7.4 inclusive, 10, 13, 14
and 15 of this Agreement.

 

11.8                        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-aminorpyridine active agent, other than Product (including a Development
Product), or the one Non-Elan Development Product (if any) selected for
commercialisation, during the period in which Acorda has an obligation to make
payments to Elan under this Agreement and for one year thereafter. The foregoing
shall be in addition to the restrictions contained in Section 2.2 of the License
Agreement, but for the purposes of that Section such selected Non-Elan
Development Product shall not be considered an “Acorda Competing Product”. For
the avoidance of doubt this Clause 11.8 shall survive termination of this
Agreement.

 

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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 Securities and Exchange
Commission.

 

12.                               Warranties

 

Elan and Acorda each represent and warrant to the other that:

 

12.1                        it has the right to enter into this Agreement and
perform its obligations under it;

 

12.2                        there are no agreements between that party and any
third party that conflict or may conflict with this Agreement; and

 

12.3                        it does not require any consents from any third
party to enter into and/or perform its obligations under this Agreement,
including in the case of Acorda, from its sub-licensee.

 

13.                               Confidentiality

 

The provisions of Section 12.1 of the License Agreement shall apply to
information disclosed between the parties for the purposes of this Agreement,
including the terms of this Agreement, as if set out in full.

 

14.                               Assignment

 

14.1                        Either party may assign this Agreement to any person
or entity to whom it could properly assign its rights and obligations under the
License Agreement.

 

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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 Securities and Exchange
Commission.

 

14.2                        Except as set out above, neither party may assign
this Agreement without the prior written consent of the other party.

 

15.                               General

 

15.1                        Limitation of Liability.  UNLESS RESULTING FROM A
PARTY’S WILLFUL MISCONDUCT OR FROM A PARTY’S BREACH OF CLAUSE 13 OF THIS
AGREEMENT (ARTICLE 12.1 OF THE LICENSE AGREEMENT) OR AS MAY BE EXPRESSLY SET
FORTH IN THE DEVELOPMENT SUPPLY AGREEMENT OR THE NON-ELAN DEVELOPMENT PRODUCT
SUPPLY AGREEMENT, AS APPLICABLE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY OR ITS AFFILIATES FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY,
PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES, OR FOR LOSS PROFITS, LOSS OF DATA,
LOSS OF REVENUE OR LOSS OF USE DAMAGES, ARISING FROM OR RELATING TO THIS
AGREEMENT OR THE DEVELOPMENT PRODUCT SUPPLY AGREEMENT OR THE NON-ELAN
DEVELOPMENT PRODUCT SUPPLY AGREEMENT, WHETHER BASED UPON WARRANTY, CONTRACT,
TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF
SUCH DAMAGES. NOTHING IN THIS CLAUSE 15.1 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT, THE
DEVELOPMENT PRODUCT SUPPLY AGREEMENT OR THE NON-ELAN DEVELOPMENT PRODUCT SUPPLY
AGREEMENT.

 

15.2                        Method of Calculation of Payments.  The parties
acknowledge and agree that the methods for calculating the royalties, fees,
supply prices, compensating payments and other payments under this Agreement and
under the license Agreement (as interpreted in accordance with this Agreement
Supply Agreement, Development Product Supply Agreement (if any) and Non-Elan
Development Product Supply Agreement (if any are for the convenience of the
parties, are freely chosen and not coerced.

 

15.3                        Parties Bound:  This Agreement shall be binding upon
and run for the benefit of the parties, their successors and permitted assigns.

 

15.4                        Relationship of the Parties:  In this Agreement,
nothing shall be deemed to constitute a partnership between the parties or make
either party an agent for the other, for any purpose whatsoever.

 

15.5                        Entire Agreement: Without prejudice to the license
Agreement and Supply Agreement and any other agreements incorporated by
reference therein, this Agreement constitutes the entire agreement and
understanding between the parties with respect to its subject matter. Except as
expressly provided, this Agreement supersedes all prior representations,
writings, negotiations or understandings with respect to that subject matter. 
The parties acknowledge that, in entering into this Agreement, they have not
relied on, and shall have no right or remedy in respect of, any statement,
representation, assurance or warranty (whether made negligently or innocently)
other than as expressly set forth in this Agreement.  Nothing in this clause
shall limit or exclude any liability for fraud.

 

15.6                        Severability: If any provision in this Agreement is
deemed to be, or becomes invalid, illegal, void

 

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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 Securities and Exchange
Commission.

 

or unenforceable under applicable laws, 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, but the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired or affected in any way

 

15.7                        Further Assurance:  Each party shall do and execute,
or arrange for the doing and executing of, each necessary act, document and
thing reasonably within its power to implement this Agreement.

 

15.8                        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.

 

15.9                        Waivers: A failure to exercise or delay in
exercising a right or remedy provided by this Agreement or by law does not
constitute a waiver of the right or remedy or a waiver of other rights or
remedies. No single or partial exercise of a right or remedy provided by this
Agreement or by law prevents further exercise of the right or remedy or the
exercise of another right or remedy.

 

15.10                 Variations.  No modification, amendment, or waiver of any
provision of this Agreement shall be valid unless in writing and signed by a
duly authorised officer or representative of each of the parties hereto.

 

15.11                 Notices:

 

15.11.1       Elan and Acorda hereby acknowledge that pursuant to
Section 12.12.1 of the license Agreement, the following addresses, fax numbers
and contact names shall apply in lieu or those originally stated therein:

 

(a)                                 in the case of Elan (which constitutes
notice):

 

Address:                                                 Elan Pharma
International limited

Monksland

Athlone, Co. Westmeath, Ireland

 

Fax:                                                                      
+(353) 9064 95402

 

Marked for the attention of: Vice President and General Counsel with a copy
(receipt of which shall not constitute notice) to:

 

Address:                                                 Elan Pharma
International limited

Treasury Building

Grand Canal Street Lower

Dublin 2, Ireland

 

Fax:                                                                      
+(353) 1709 4700

 

Marked for the attention of: Vice President, Commercial Management

 

(b)                                 in the case of Acorda (which constitutes
notice):

 

Address:                                                 Acorda
Therapeutics, Inc.

15 Skyline Drive

Hawthorne, New York 10532

 

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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 Securities and Exchange
Commission.

 

Fax:                                                                       (914)
347-4560

 

Marked for the attention of: Ron Cohen, President and Chief Executive Officer
with a copy (receipt of which shall not constitute notice) to the attention of:

 

General Counsel, at the same address

 

15.11.2       Subject to those changes, Section 12.12 of the License Agreement
shall apply to any notice required under this Agreement as if set out in full.

 

15.12                 Governing Law and Arbitration: 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. 
Section 12.14 of the License Agreement (arbitration) is hereby incorporated as
if it were set out at length herein and is applicable to Non-Elan Development
Product as provided herein, and reading references in that Clause to Article 10
of the License Agreement (Committee) as interpreted in accordance with this
Agreement.

 

***

 

Signatures begin on next page

 

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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 Securities and Exchange
Commission.

 

EXECUTED by the parties on the date appearing at the top of page 1.

 

SIGNED

 

 

/s/ William F. Daniel

 

Duly authorised for and on behalf of

 

ELAN PHARMA INTERNATIONAL LIMITED

 

 

 

SIGNED

 

 

/s/ Ron Cohen

 

Duly authorised for and on behalf of

 

ACORDA THERAPEUTICS, INC.

 

 

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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 Securities and Exchange
Commission.

 

SCHEDULE 1

 

[*****]

 

[*****]

 

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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 Securities and Exchange
Commission.

 

SCHEDULE 2

WORK PLAN FORMAT

 

Compound:                                             (INSERT DETAILS)

 

Scope of Work:                       (INSERT DETAILS)

 

Elan Activities:                        (INSERT DETAILS)

 

Acorda Activities:         (INSERT DETAILS)

 

Estimated Fee:                           (INSERT DETAILS)

 

The Estimated Fee for the Elan services contemplated by this WorkPlan is
                                         U.S. dollars (US $0000.00), including
all out-of-pocket expenses (“Total Estimated Fee”).  With respect to any
potential cost overruns, the Parties agree that such overruns shall not exceed
[*] of the Total Estimated Fee.  Acorda shall not be required to pay and Elan
shall have the right to discontinue it services if the cost of performing the
services under this workplan exceeds [*****] of the Estimated Fee.  Elan shall
resume unperformed services if an amendment to this work plan or a new work plan
to complete the services is agreed and executed by Acorda and Elan.

 

Acorda shall reimburse Elan as set out in this Work Plan for labour at Elan’s
FTE plus [*****] and actual out-of-pocket expenses incurred by Elan in
conducting work under this Work Plan.

 

Elan shall invoice Acorda for such costs no more than once per month.  Elan
shall provide a reasonably detailed invoice to identify the work performed and
costs incurred under the invoice. Invoices shall be paid by Acorda within thirty
(30) days of invoicing and Elan shall, without prejudice to other remedies, be
entitled to stop work if payment is not made within this time period.

 

Estimated
Timelines:                                                                                                                                                       
(INSERT DETAILS)

 

Elan estimates that the Elan activities detailed in this Work Plan will be
completed approximately                     weeks/months after this Work Plan
has been executed.

 

Should a conflict arise between the terms and conditions of this Work Plan and
the terms and conditions of the Development and Supplemental Agreement, Elan and
Acorda agree that the terms and conditions of the Development and Supplemental
Agreement shall prevail.

 

Agreed and Accepted by:

 

Duly authorised for and on behalf of

 

Duly authorised for and on behalf of

Elan Pharma International Ltd.

 

Acorda Therapeutics, Inc.

 

 

 

By:

 

 

By:

 

 

 

 

 

 

Name:

 

Name:

Title:

 

Title:

Date:

 

Date:

 

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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 Securities and Exchange
Commission.

 

SCHEDULE 3

SELECTION CRITERIA

 

Criteria for Evaluation:

·              Specific criteria are to be developed based on [*****].

·               The new formulation must be assessed [*****].

·               Timing: [*****]

·               Cost: [*****]

 

End of Schedule 3

 

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