Exhibit 10.21


 


	
  AERES BIOMEDICAL LIMITED

  	
   

  	
  ACORDA THERAPEUTICS

  



 


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.


 


RESEARCH
COLLABORATION AND COMMERCIALISATION

AGREEMENT


 


This Agreement is made
the           day of
February, 2002, (the “Effective Date”) between


 


(1)               AERES Biomedical Limited, whose principal place of business is situated at 1-3 Burtonhole
Lane, Mill Hill, London NW7 1AD, England (hereinafter also called “AERES”)


 


and:


 


(2)               Acorda Therapeutics, Inc., whose principal place of business is situated at 15 Skyline Drive,
Hawthorne, NY 10532 (hereinafter also called “ACORDA”); and:


 


Recitals


 


WHEREAS, ACORDA has
research expertise, know-how and proprietary rights relating to discovery
research leading toward new therapeutic products based on ACORDA monoclonal
antibodies; and


 


WHEREAS, ACORDA has
identified and developed know-how and proprietary rights to certain monoclonal
antibodies, including the antibodies designated by ACORDA as Lym22 and Lym46, which may be capable of
promoting the re-myelination of nerve sheaths in certain degenerative disease
conditions; and


 


WHEREAS, AERES has developed
processes and vectors to create stable cell lines expressing antibody genes and
producing antibodies for research which are likely to be suitable for further
development and optimisation for large scale manufacture; and


 


WHEREAS, AERES has genetic
engineering expertise to modify antibodies expressed as IgM so that they are
expressed as IgG, which modification is sometimes, in one aspect, commonly
referred to as “class switching”; and


 


WHEREAS, ACORDA wishes
AERES create stable cell lines involving inter-alia the modification of antibodies Lym22 and Lym46 in accordance with the
research plan set out in Annex A hereto and referred to herein as the “Research
Plan”; and


 


WHEREAS, AERES has the
necessary expertise and facilities and is willing to perform such services for
ACORDA.


 


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NOW, THEREFORE, in
consideration of the foregoing promises and of the mutual covenants and
obligations hereinafter set forth, the parties agree as follows:


 


ARTICLE I -
Definitions


 


As used in
this Agreement, the following terms when used with initial capital letters
shall have the following meanings and, where the context so permits, the
singular shall include the plural and vice versa:


 


1.1              “Affiliate”
shall mean any entity that directly or indirectly controls, is controlled by,
or is under common control with a party, and for such purposes “control” shall
mean ownership of more than fifty percent (50%) of the voting interest, or such
lower maximum amount allowed by the law governing the ownership of said
organization. For the purposes of this Agreement, any reference to “ACORDA”
shall where the context so permits mean same reference to “ACORDA (and/or) its
Affiliates” , and any reference to “AERES shall, where the context so permits,
mean same reference to “AERES (and/or) its Affiliates.


 


1.2              “Commercial
Introduction” in a given country shall mean the date upon which ACORDA or one
or more Licensees (as defined hereunder) have first achieved Net Sales in such
country following the final issuance of all required licences and approvals by
the United States Food and Drug Administration (“FDA”) (or equivalent licences
and approvals in countries other than the United States) allowing for the
manufacture and sale of a Product for human use.


 


1.3              “Field”
shall mean the development and production of antibodies potentially capable of
promoting the re-myelination of human nerve fibres in certain degenerative
disease conditions.


 


1.4              “Invention”
shall mean an invention by either party arising from work conducted pursuant to
the Research Plan.


 


1.5              “Know-how”
shall mean all information and know-how in the Field which is owned with the
right to disclose or otherwise controlled during the term of this Agreement,
including, without limitation, processes, techniques, methods, products,
transformed cells, other biological materials and compositions which are
related to the Field.


 


1.6              “Licence”
shall mean any licence granted by Acorda to make or have made, use, distribute
and/or sell Products.


 


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1.7              “Licensee”
shall mean any organisation licensed by ACORDA to make or have made, use,
distribute and/or sell Products.


 


1.8              “Net
Sales” shall mean actual billings by ACORDA and/or its Licensees to independent
third parties for Products less the following amounts:


 


(i) discounts or rebates actually allowed
or granted; (ii) credits or allowances actually granted on rejections or
returns, including for recalls or damaged goods (not exceeding the original
billing); (iii) outbound freight, postage, shipping and insurance charges
prepaid or allowed; (iv) bad debts relating to sales of Products that are
actually written off by ACORDA in accordance with generally accepted accounting
principles, consistently applied, during the applicable royalty calculation
period; and (iv) sales, tariff duties and/or use taxes or other similar
governmental charges included in the invoiced amount.  No allowance or deduction shall be made for commissions or
collections, by whatever name known.


 


1.9              “Product”
shall mean any product incorporating or derived from an antibody that is
produced by a Stable Cell Line.


 


1.10         “Stable
Cell Line” shall mean any cell line made by AERES and contracted by ACORDA
hereunder together with any such cell line subsequently developed and optimised
for the manufacture of antibodies.


 


1.11       “Third
Party” shall mean any entity other than AERES or ACORDA and their respective
Affiliates.


 


Article II -
Research Collaboration


 


2.1                                 Upon the execution of this Agreement and the receipt from ACORDA of
the necessary materials and information as specified in Article 2.2 below,
AERES will undertake the class switching of ACORDA antibodies Lym22 and/or
Lym46 together with the creation of a Stable Cell Line expressing each antibody
in accordance with the Research Plan set forth in Annex A hereto.


 


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2.2                                 ACORDA shall, at its expense and without charge to AERES, deliver to
AERES ACORDA antibodies Lym22 and Lym46 and plasmids incorporating genes
expressing said ACORDA antibodies and such Know-how including related technical
information as sufficient (in the reasonable judgement of both parties) to
enable AERES to carry out the Research Plan. 
AERES shall disclose to ACORDA all Know-how created or used in carrying
out the Research Plan and shall make such disclosure only to ACORDA except as
provided in Article VII.


 


2.3                                 AERES shall permit duly authorized employees of ACORDA to have
access to AERES’s laboratories from time to time at mutually agreeable times
and upon reasonable notice.


 


2.4                                 ACORDA shall obtain and retain all rights, title and interest in DNA
and RNA sequences expressing ACORDA antibodies Lym22 and Lym46 and any and all
cell lines (including Stable Cell Lines) expressing the same.  AERES hereby assigns and agrees to assign
all rights, title and interest in DNA and RNA sequences expressing ACORDA
antibodies Lym22 and Lym46 and any and all cell lines (including Stable Cell
Lines) expressing the same, and in all Inventions of AERES relating to any of
the foregoing.  Antibodies Lym22 and
Lym46 and cell lines for their production will be maintained within the sole
possession and control of AERES (other than transfer to ACORDA as contemplated
herein), and will not be distributed, transferred or sold by AERES to any third
party for any purpose whatsoever without the prior written consent of ACORDA.


 


2.5                                 AERES shall retain all rights, title and interest in antibody
engineering techniques, gene expression vectors, materials and Know-how used or
developed in the course of the Research Plan at Annex A, including the use of
such vectors for the expression of any gene or gene construct other than DNA
and RNA sequences encoding genes and gene constructs developed for ACORDA
hereunder.  In particular, information
relating to antibody engineering techniques and gene expression vectors
comprising Know-how used or developed by AERES in the course of the Research
Plan at Annex A shall be (or remain) the confidential property of AERES, and information
(“Information”) concerning DNA and RNA sequences expressing ACORDA antibodies
Lym22 and Lym46, including protein, DNA, RNA, cell lines, and anything derived
therefrom generated by AERES in the course of carrying out the Research Plan
(“Materials”) shall be (or remain) the confidential property of ACORDA.


 


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2.6                                 AERES agrees that, at ACORDA’s request, it will return to ACORDA any
and all Information provided by ACORDA in documentary form and any and all
unused Materials and will return or destroy the same and any copies thereof
made by AERES, its directors, officers or employees, except that, in the event
that ACORDA shall have failed on a timely basis to pay AERES in full the
payments required under Article III of this Agreement, AERES shall have the
right to provide written notice describing such failure and if ACORDA does not
cure the failure to pay within thirty (30) days of receipt of such notice, then
AERES will have the right to withhold and destroy any materials created during
any stage of the Research Plan in respect of which payment has not been made in
full unless an alternative payment has been agreed by the parties and paid in
full pursuant to the provisions for early termination of the Research Plan set
out in Article 8.4 below.  AERES may,
subject to the continuing obligations of non-disclosure and non-use expressed
herein, retain one copy of the Information in its legal files and a sample of
the Materials in a secure depository, solely in order to be able to evidence
the work performed hereunder if so required for any future legal or regulatory
purpose but for no other use.


 


2.7                                 Except for the limited rights expressly granted in this Article II,
nothing herein shall be deemed to grant to either party any other rights or
licences under any patent applications or patents or under any know-how,
technology or inventions of the other party.


 


2.8                                 AERES covenants that it shall not provide to any Third Party any
services in the Field similar to those contemplated in this Agreement for a
period of one year from the Effective Date.


 


Article III -
Payments for Research Plan


 


3.1                                 ACORDA will pay AERES, for its research efforts carried out in
accordance with Annex A, the payments set forth in the cost schedules attached
at Annex B which shall be invoiced by AERES on signature of this Agreement and
on completion of each of the research Milestones specified in Annex A.  ACORDA shall make payment in settlement of
said invoices by wire transfer in Pounds Sterling (UK£) within 30 (thirty) days
of the receipt of invoice to the account of AERES Biomedical Ltd. at “The Royal
Bank of Scotland, London Cavendish Square Branch” (Bank Sort Code 16-00-30,
Account No. 10114879), or such other account as shall be nominated by
AERES  from time to time, and the
transaction identified as “Agreement dated [as hereinabove] with ACORDA
Therapeutics.


 


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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 Commission.


 


3.2                                 In the event that ACORDA does not agree that any one of the above
Milestones has been met, ACORDA shall notify AERES within 10 (ten) working days
from the date of delivery of the materials and written report relating to said
Milestone.  On receipt of said
notification, AERES will hold invoicing in respect of said Milestone for up to
30 (thirty) days, and ACORDA and AERES will each use best efforts to reach
agreement on the clarification and redefinition of the Milestone(s) and (if
applicable) the corresponding cost schedule. 
In the event of an unresolved dispute arising under this Article 3.2,
AERES can cease all ongoing work hereunder until such dispute is resolved, and
the Parties will seek in good faith a mediation to assist in resolving the
dispute as soon as practicable.


 


3.3                                 All payments hereunder shall be made free and clear of and without
deduction or deferment in respect of any demand, set-off, counterclaim or other
dispute. ACORDA and AERES shall use their best endeavours to do all such lawful
acts and to sign all such lawful documents as will enable ACORDA to take
advantage of any applicable legal provision or any double taxation treaty with
the object of paying the sums due AERES without imposing or withholding any
tax.


 


Article IV -
Royalty Payments


 


4.1                                 ACORDA shall pay to AERES, in consideration for the use of its
proprietary gene expression vectors, materials and Know-how used in the
construction by AERES of a Stable Cell Line, an earned royalty of [*] of the Net Sales of ACORDA and its
Licensees as defined herein.  Unless
prohibited by law, ACORDA’s obligation to pay such earned royalties shall subsist
and shall continue for a period of twelve (12) years after Commercial
Introduction in any country. 
Thereafter, ACORDA shall have a fully paid-up licence to make or have
made, use and/or sell Products in said country.


 


4.2                                 Sales between ACORDA, its Affiliates and Licensees shall not be
subject to a royalty, but in such cases the royalty specified in Article 4.1
shall be calculated upon such Affiliates’ and Licensees’ Net Sales to
independent third parties.


 


4.3                                 ACORDA agrees that any Licence granted by it shall provide that the
obligations owed by ACORDA to AERES under Articles IV, V, VII and X of this
Agreement shall be reflected in the wording of the said Licence by a consistent
and equivalent obligation on the part of the Licensee to ACORDA, which ACORDA
shall use its best endeavours to enforce to the benefit of AERES, in the event
of any breach thereof.  In particular,
ACORDA shall use reasonable efforts to place AERES in a position where AERES
can adequately monitor and enforce payment of all royalties due to it in
consequence of this Agreement.


 


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4.4                                 ACORDA agrees to provide to AERES written notification of any fully
executed Licence entered into by ACORDA.  Such notification shall include
confirmation that the Licence conforms to the provisions of Article 4.3 and
shall provide all relevant information pursuant to Article 4.3 including the
scope of the Licence in terms of manufacturing and/or distribution, marketing
and/or sales and the territories covered.


 


Article V -
Reports and Records


 


5.1                                 ACORDA shall keep full, true and accurate books of account
containing all particulars that may be necessary for the purpose of showing the
amounts payable to AERES and the accuracy of the reports made to AERES hereunder.  Such records shall be retained by ACORDA for
three (3) years following the end of the calendar year to which they pertain.
If so requested by AERES, abstracts thereof shall be made by an independent,
certified public accountant appointed by AERES, all at the expense of AERES,
except in the event that the results of the audit reveal a discrepancy to be
corrected in AERES’s favour of five percent (5%) or more, then the audit fees
shall be paid by ACORDA.  Any such
discrepancies will be promptly corrected by a payment or refund as appropriate.


 


5.2                               ACORDA, within ninety (90) days after March 31, June 30, September
30 and December 31, of each year after Commercial Introduction, shall deliver
to AERES true and accurate reports, giving such particulars of the business
conducted by ACORDA, its Affiliates and Licensees during the preceding quarter
as shall be pertinent to a royalty accounting hereunder.  These shall include at least the following:


 


(a)                                  number of Products sold;


 


(b)                                 total billings for Products sold on a country-by-country basis;


 


(c)                                  deductions applicable as provided in Article 1.8;


 


(d)                                 total royalties due;


 


(e)                                  names and addresses of all Affiliates and Licensees of ACORDA under
this Agreement.


 


5.3                                 With each such report submitted, ACORDA shall pay to AERES the
royalties due and payable under this Agreement.  If no royalties shall be due, ACORDA shall so report.


 


5.4                                 The royalties due shall be paid by ACORDA to AERES in Pounds
Sterling (UK£) and shall be remitted to a bank designated in writing by AERES.


 


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5.5                                 If a sum payable under this Agreement shall be overdue for thirty
(30) days, ACORDA shall pay AERES interest on the sum outstanding at the rate
of six percent (6%) per annum above the base rate of the Royal Bank of Scotland
plc applying and calculated on a daily basis from the date that payment became
due in respect of said sum; provided however, that if such interest rate shall
be in excess of that allowed by applicable law, then the highest rate permitted
by law shall apply.  The payment of such
interest shall not foreclose AERES from exercising any other rights it may have
a consequence of the lateness of any payment.


 


Article VI -
Warranties and Representations


 


6.1                                 AERES warrants and represents that, to the best of its knowledge and
belief, there are no known outstanding claims or encumbrances which would
prevent ACORDA from making, using or selling Products. AERES warrants and
represents that the use of AERES’ gene expression vectors as currently
designed, the expression of recombinant proteins (including antibodies) in
eukaryotic cell lines (including CHO cells) and/or the selection strategies
used by AERES to identify and amplify the eukaryotic cell clones expressing
recombinant proteins and ACORDA’s use, development and commercialization of
Products will not infringe United States Patent No. 5,225,539.  ACORDA however acknowledges the existence, inter alia,
of the third party patents listed in Exhibit C whose claims may cover the use
of AERES’ gene expression vectors as currently designed, the expression of
recombinant proteins (including antibodies) in eukaryotic cell lines (including
CHO cells) and/or the selection strategies used by AERES to identify and
amplify the eukaryotic cell clones expressing recombinant proteins. For
the avoidance of doubt, ACORDA hereby accepts and agrees that it has the sole
responsibility to pursue and enter into any third party licences that may be
necessary for this purpose.


 


6.2                                 Except as otherwise expressly set forth in this Agreement, AERES
makes no representations and extends no warranties of any kind, either express
or implied, in respect of antibodies Lym22 and Lym46 or any vector or cell line
expressing the same or any information or materials provided to ACORDA
hereunder including but not limited to warranties of merchantability, fitness
for any particular purpose, or the validity of any patent rights, issued or
pending.


 


6.3                                 Each of AERES and ACORDA warrant and represent to the other that it
has the full right and authority to enter into this Agreement, and that it is
not aware of any impediment which would compromise or limit its ability to
comply fully with the terms and conditions of this Agreement.


 


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Article VII -
Secrecy


 


7.1                                 Any information of a confidential nature conveyed by one party to
the other under this Agreement and marked as “confidential” shall be the
“Confidential Information” of such party (except as otherwise provided below in
this Article VII), and may include, but not restricted to, Know-how created or
used in the development of Stable Cell Lines or the production of
antibodies.  All Confidential
Information of a party shall be treated as strictly confidential by the other
party during the term of this Agreement and for five (5) years thereafter, as
if it were its own proprietary and confidential information, and such party
shall take all reasonable steps to insure that the other’s Confidential
information will not be disclosed or communicated to third parties or used for
purposes other than for carrying out its obligations or exercising its express
rights granted under this Agreement.


 


7.2                                 A party shall be relieved of the obligations of Section 7.1 solely
with respect to particular Confidential Information of the other party to the
extent that such party can demonstrate by proper evidence that such
Confidential Information:


 


1)                                      was known by such party prior to disclosure of such Confidential
Information to it by the other party; or


 


2)                                      is or becomes publicly known through no fault or omission
attributable to such party; or


 


3)                                      is lawfully obtained by such party from a third party that has the
right to disclose such information without a duty of confidentiality and is in
lawful possession thereof.


 


For clarity,
any Confidential Information of ACORDA that was originally developed by AERES
hereunder and assigned to ACORDA as provided in Article II, shall not be
subject to the exception to confidentiality in subclause 1) above.


 


7.3                                 AERES hereby confirms that information concerning the remyelinating
antibody program, together with the vectors and cell lines expressing the same,
gene constructs containing including, without limitation, protein, DNA, RNA,
plasmids and organisms, and anything derived therefrom (the “Materials”)
together with any confidential or proprietary information obtained from ACORDA
or developed for ACORDA under the Confidential Disclosure Agreement of
             
or generated by AERES in the course of performing Services under this
Agreement, are and shall be the Confidential Information of ACORDA, and shall
be subject to all the obligations of AERES under Section 7.1.


 


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7.4                                 Notwithstanding the limitations in this Article VII, each party
shall have the right to disclose such Confidential Information solely to the
extent required under any law, ruling or regulation of a governmental agency or
a court of competent jurisdiction, and for the purpose of satisfying national,
state or local requirements in order to conduct studies with the Product or to
obtain regulatory approval for the commercial sale of a Product, provided,
however, that such disclosing party will first give reasonable
advance notice to the other party of such required disclosure and will use its
best efforts to limit such disclosure to that which is required and to secure
confidential treatment, or to assist the other party in securing a protective
order or confidential treatment, of such information prior to its disclosure
(whether through protective orders or otherwise).


 


7.5                                 The obligations imposed upon the parties under this Article VII
shall survive termination of this Agreement for any reason whatsoever and
continue for five years thereafter.


 


Article VIII -
Term and Termination


 


8.1                                 The term of this Agreement shall commence on the effective date and
shall continue on a country by country basis until no further payments in a
given country are due from ACORDA to AERES under this Agreement unless terminated
in accordance with the sections set forth below.


 


8.2                                 Either party may terminate this Agreement forthwith upon notice to
the other party in the event of such other party going into insolvent
liquidation or having a winding up order made against it unless such order is
rescinded within 30 days.


 


8.3                                 Upon any material breach or default of this Agreement by either
party, other than as set out in Article 8.2 above, which shall always take
precedence in that order over any material breach or default referred to in
this Article 8.3, the non-breaching party shall have the right to terminate
this Agreement and the rights, privileges and license granted hereunder by
ninety (90) days’ notice to the breaching party.  Such termination shall become effective unless the breaching
party shall have cured any such material breach or default prior to the
expiration of the ninety (90) day period, or has contested the existence of, or
failure to cure, a material breach and has obtained an injunction from a court
of competent jurisdiction granting a stay of termination, or the parties have
agreed to proceed with the resolution of the dispute as provided in Article
10.1.


 


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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 Commission.


 


8.4                                 ACORDA may terminate the Agreement at any time prior to completion
of the work under the Research Plan at Annex A on one (1) month’s prior written
notice to AERES, except that ACORDA shall not be permitted to terminate the
Research Plan prior to the completion of research Milestone 1 (at Annex A), and
provided that if ACORDA for any reason terminates this Agreement during any
subsequent stage of the Research Plan (as defined by the corresponding research
Milestone) then ACORDA shall pay AERES for that stage an amount invoiced by
AERES which shall be in the same proportion to the total amount payable in
respect of the corresponding research Milestone (specified in Annex A) as the
proportion of the total amount of work carried out by AERES when such notice of
termination by ACORDA pursuant to this Article 8.4 takes effect.  AERES shall use its reasonable endeavours to
mitigate and reduce its costs incurred in respect of any incomplete stage.
Unless ACORDA has terminated this Agreement as provided hereunder, ACORDA shall
be deemed to have approved the commencement of the next stage of the Research
Plan specified in Annex A, thirty-five (35) days after completion of Milestone
1.


 


8.5                                 Upon termination of this Agreement for any reason, nothing herein
shall be construed to release either party from any obligation that matured
prior to the effective date of such termination.  In particular, the termination of this Agreement for any reason
shall be without prejudice to:


 


a)                                      any party’s right to receive all payments to which such party is
entitled under this Agreement and obtain performance of any obligations
provided for in this Agreement which survive termination by their terms or by
fair interpretation of this Agreement; and


 


b)                                     any other remedies which any party may then or thereafter have
hereunder.


 


8.6                                 The right of either party to terminate this Agreement shall not be
affected in any way by its waiver of or failure to take action with respect to
any previous default.


 


Article IX -
Patents


 


9.1                                 Any and all patents and patent applications arising out of the
Research Plan specified in Annex A which include claims or statement of
inventions [**] shall be owned by ACORDA which shall have the sole right to
file such applications and will meet all costs in relation thereto.  AERES will assign any and all rights as necessary
to vest such ownership in ACORDA.


 


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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 Commission.


 


9.2                                 In the event that ACORDA wishes to include in any patent application
referred to in Article 9.1 any statement of invention (claim) to a patentable
invention [**] then ACORDA shall advise AERES of the same and shall consult
with AERES as to the programme of patent protection to be initiated and such
patent application shall be filed in the appropriate names in accordance with
the law of the country of filing.  AERES
shall have the right to file a separate programme of patent protection solely
in the name of AERES claiming priority rights from said application for
[**]  and ACORDA shall have the right to
file a programme of patent protection solely in the name of ACORDA claiming
priority rights from said application for the protection of the production of
antibodies within the Field. 
Notwithstanding the foregoing, ACORDA shall prior to filing any such
patent application disclose the same to AERES which shall have the right to
comment on the wording of the said patent application and its statements of
invention (claims) relating to processes of obtaining antibodies, such comments
shall be reasonably considered by ACORDA. Where such patent application has
been filed by ACORDA, each party shall provide to the other the necessary
documentation to allow such party to proceed with a programme of patent
protection in its own name as provided above.


 


9.3                                 The parties shall consult and co-operate fully on patent filings as
provided in Article 9.1 and 9.2 but this shall not delay timely filing of patent
applications by either party.  Each
party shall supply the other in a timely manner with copies of relevant patent
applications and drafts or amendments thereof as provided in Article 9.2.  Each party shall reasonably assist the other
in filing, prosecution and maintenance of patent applications and patents
arising from the collaboration.


 


9.4                                 When ACORDA undertakes filing, prosecution and maintenance of patent
applications using its patent attorneys and if ACORDA does so after having both
consulted and afforded AERES the opportunity to comment on said patent
applications and/or file separately pursuant to Article 9.2 then neither ACORDA
nor its patent attorneys shall be liable to AERES in respect of any act,
omission, default or neglect on the part of the patent attorneys.


 


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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 Commission.


 


9.5                                 For the avoidance of doubt it is hereby stated that ACORDA will not
exert any of its claims to intellectual property arising out of the
collaboration pursuant to this Agreement against AERES in a manner which would
inhibit AERES’s freedom to work in the general area of [**] AERES shall not,
except in the event of an uncured material breach by ACORDA of this Agreement,
exert any of its claims to intellectual property arising out of the said
collaboration, against ACORDA in a manner which would inhibit ACORDA from
commercialising any Product.


 


9.6                                 This Article 9 shall survive termination of this Agreement.


 


Article X -
Arbitration


 


10.1                           If there is any dispute between the parties relating to the
interpretation, implementation or application of this Agreement, or any other
matter in connection with it, they will attempt in good faith to negotiate a
settlement.  If the matter is not
resolved by negotiation, the parties will refer the dispute to mediation in
accordance with CEDR (Centre for Dispute Resolution, London) procedures
(“ADR”).  If the parties fail to agree
on a settlement within 28 days of the initiation of the ADR procedure, either
party may refer the matter to binding arbitration by a sole arbitrator.  Unless otherwise agreed by the parties, the
place of the arbitration shall be London, England.  The arbitrator shall be agreed by the parties, but if they fail
to agree within 14 days of one party giving the other written notice requiring
arbitration, either can apply to the President for the time being of the Law
Society of England and Wales, who shall then nominate an appropriate
independent arbitrator who shall, insofar as practicable, have experience in
disputes of the nature which has arisen. 
The decision of the arbitrator will be binding on both parties and the
issues decided by the arbitrator shall not be raised in legal proceedings by
either party.  Reference to mediation or
arbitration shall be without prejudice to the rights of the parties to seek an
injunction or other emergency interim relief before any court of competent
jurisdiction.


 


Article XI -
Miscellaneous


 


11.1                           Any notice required to be given hereunder shall be considered
properly given if in writing, delivered personally or by facsimile (and promptly
confirmed by personal delivery or courier), courier, telex or other electronic
media or by first-class mail with postage properly prepaid addressed to the
other party at the respective address as shown below.  Either party may change its address by written notice:


 


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  If to
  ACORDA:

  
	
   

  
	
  Acorda
  Therapeutics, Inc.,

  
	
  15
  Skyline Drive,

  
	
  Hawthorne,

  
	
  NY 10532

  
	
  U.S.A.

  	
   

  
	
  Attention:

  	
  President

  
	
   

  
	
  If to AERES:

  
	
   

  
	
  AERES
  Biomedical Ltd.

  
	
  1-3
  Burtonhole Lane

  
	
  Mill Hill

  
	
  London, NW7
  1AD

  
	
  U.K.

  	
   

  
	
  Attention:

  	
  Chief
  Operating Officer

  
	
   

  



 


11.2                           Each of the parties shall contribute, to the extent reasonable,
facilities, supplies, personnel and other resources without charge or expense
to the other as may be necessary for proper performance of the respective
obligations under this Agreement and that are consistent with Annex A.  To the extent reasonable and except as may
otherwise be expressly provided, each party shall bear its own out-of-pocket
costs and disbursements incurred in the performance of this Agreement.


 


11.3                           Nothing contained in this Agreement, or otherwise, shall constitute
the parties as partners with one another or render either liable for the debts
or obligations of the other. 
Furthermore, nothing in this Agreement shall be construed to constitute,
create, give affect to or otherwise imply a joint venture or formal business
organization of any kind.


 


11.4                           Except as required by law, neither party shall use any of the names
of the other party, nor of any Affiliate, shareholder, director, employee or
associate of the other party, in connection with any publicity, including but
not limited to any brochure, press release or statement to the press without
the prior approval of the other party confirmed in writing, which shall not be
unreasonably withheld.


 


14

















 


11.5                           ACORDA agrees to indemnify and hold harmless AERES and its
Affiliates, and their respective officers, employees and agents from and
against any and all claims, damages and liabilities asserted by third parties,
both government and private, arising from the manufacture, use or sale of
Products by ACORDA or by its Affiliates or Licensees, or by any other party so
authorised by ACORDA or by its Affiliates or Licensees, or the use thereof by
others, against said claims, damages and liabilities including ultimate
consumers except to the extent that such claims, damages and liabilities arise
from the gross negligence or wilful misconduct of AERES.


 


11.6                           AERES agrees to indemnify and hold harmless ACORDA from and against
any and all loss or damage suffered by ACORDA if it is unable to obtain final
issuance of all required licences and approvals by the FDA (or the equivalent
licences and approvals in countries other than the United States) allowing for
the manufacture and sale of a Product for human use and such failure results
from the negligence or willful misconduct of AERES in relation to information
or materials provided by AERES, provided always:  (a) that ACORDA shall use all due diligence to identify and bring
to the attention of AERES any potential deficiencies in the information or
materials provided by it, so as to afford AERES a reasonable opportunity of
rectifying the same; and  (b) that
ACORDA shall itself act with all due diligence in avoiding unnecessary or
premature costs or losses; and  (c) that
(for the avoidance of doubt) this indemnity shall not extend to any indirect or
consequential loss nor any claim, damage or liability arising in respect of
Affiliates, Licensees, distributors or ultimate consumers of Products.


 


11.7                           This Agreement and the rights and licence granted herein shall be
binding upon and shall inure to the benefit of successors of the parties
hereto, or to an assignee of all or substantially all of the goodwill and
entire business and assets of a party hereto, but shall not otherwise be
assignable without the prior written consent of the other party, which consent
will not be unreasonably withheld but shall be conditional, inter alia,
upon the formal acceptance by the assignee of the payment obligations and terms
and conditions of this Agreement.


 


11.8                           The parties hereto acknowledge that this Agreement sets forth the
entire Agreement and understanding of the parties hereto as to the subject
matter hereof, and shall not be subject to any change or modification except by
the execution of a written instrument subscribed to by the parties hereto.


 


11.9                           The failure of any party to exercise or enforce any right granted in
this Agreement shall not be deemed to be a waiver of such right or operate to
bar the exercise of enforcement thereof at any time or times thereafter.


 


15

















 


11.10                       Except where required by law, neither party shall use the name of
any other party or make specific reference to the terms of this Agreement in
any press release, advertisement or other public statement without the prior
written consent and approval of the other party.


 


11.11                     The provisions of this Agreement are severable, and in the event
that any provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of the law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.


 


11.12                     This Agreement shall be construed, governed, interpreted and applied
in accordance with the laws of England, except that questions affecting the
construction and effect of any patent shall be determined by the law of the
country in which the patent was granted.


 


11.13       All captions herein are for convenience
only, and shall not be interpreted as having any substantive effect.


 


IN WITNESS THEREOF, the parties hereto have caused this Agreement to be duly executed
in duplicate by their authorized officers effective as of the date first
written above.


 


 


	
  AERES BIOMEDICAL LTD.

  
	
   

  
	
   

  
	
  By:

  	
   

  	
   

  
	
   

  
	
   

  	
  Dr Tarran Jones

  
	
   

  	
  Chief Executive Officer

  
	
   

  
	
   

  
	
  Date:

  
	
   

  
	
  Acorda Therapeutics, Inc.

  
	
   

  
	
   

  
	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  Date:

  



 


16

















 


	
  AERES BIOMEDICAL

  	
  ANNEX A

  	
  COMMERCIAL IN CONFIDENCE

  



 


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.


 


ANNEX A


 


Stable Expression of a
Recombinant Antibody in CHO Cells


and Subsequent CHO Cell
Line Development


 


[*]


 


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.


 


[*]


 


2

















 


Certain
portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately
filed with the Commission.


 


[*]


 


3

















 


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.


 


Research Milestones


 


Milestone 1.


 


[*]


 


Milestone 2.


 


[*]


 


4

















 


	
  AERES BIOMEDICAL 

  	
  ANNEX B

  	
  COMMERCIAL IN CONFIDENCE

  



 


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.


 


ANNEX B


 


Payments


 


The following
payments will be invoiced to CUSTOMER and will be paid to AERES Biomedical
Limited on signature and subsequently upon completion of each of the Milestones
specified in Annex A. [*] of the total contract price will be invoiced to
Acorda Therapeutics and will become due to AERES Biomedical immediately upon
signature of the Agreement.  The advance
payment in respect of each Stable Cell Line contracted for is non-refundable.


 


 


	
  For the
  first Stable Cell Line (Lym22 or Lym46)

  
	
   

  
	
   

  	
  •

  	
  Advance Payment:

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  •

  	
  Completion of Milestone 1:

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  •

  	
  Completion of Milestone 2:

  	
   

  	
  [*]

  
	
   

  
	
  For the
  second Stable Cell Line (Lym46 or Lym22)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  •

  	
  Advance Payment:

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  •

  	
  Completion of Milestone 1:

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  •

  	
  Completion of Milestone 2:

  	
   

  	
  [*]

  



 


 


A milestone
shall be considered completed for the purpose of payment when Acorda
Therapeutics has received all documentation and materials required to be
transferred as described under the applicable milestone description in Annex A
above.


 


Payment terms are 30 days from date of invoice


 


5

















 


	
  AERES BIOMEDICAL 

  	
   

  	
   

  



 


ANNEX C


 


Third Party
Patents of which AERES is aware as of January 2002


 


HCMV PATENTS


 


US5168062 : Transfer vectors and microorganisms
containing human cytomegalovirus immediate-early promoter-regulatory DNA
sequence


 


INVENTORS: Stinski;
Mark F.


ASSIGNEES:
University of Iowa Research Foundation


ISSUED: Dec. 1
, 1992


FILED:
Sep. 10, 1990


SERIAL NUMBER:
US1990000582130


 


ABSTRACT:


 


The cloning of
a eucaryotic promoter-regulatory region that functions preferentially in human
cells is disclosed. The invention is exemplified by the cloning of a section of
the human cytomegalovirus genome comprising a DNA sequence with regulatory and
promoter signals and an initiation site for RNA synthesis. The fragment, termed
the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained
from purified HCMV DNA.


 


US5385839 : Transfer vectors and microorganisms
containing human cytomegalovirus immediate-early promoter regulatory DNA
sequence


 


INVENTORS: Stinski;
Mark F.


ASSIGNEES:
University of Iowa Research Foundation


ISSUED:
Jan. 31, 1995


FILED: June 17, 1992


SERIAL NUMBER:
US1992000900056


 


ABSTRACT:


 


The cloning of
a eucaryotic promoter-regulatory region that functions preferentially in human
cells is disclosed. The invention is exemplified by the cloning of a section of
the human cytomegalovirus genome comprising a DNA sequence with regulatory and
promoter signals and an initiation site for RNA synthesis. The fragment, termed
the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained
from purified HCMV DNA.


 


6

















 


DHFR SELECTION PATENTS


 


US4399216: Processes for inserting DNA into
eucaryotic cells and for producing proteinaceous materials


 


INVENTORS: Axel R., Wigler M.H., Silverstein S.J..


ASSIGNEES: The Trustees of Columbia University,
New York, NY


ISSUED:
Aug. 16, 1983


FILED: Feb. 25,
1980


SERIAL NUMBER: US1980000124513


 


ABSTRACT:


 


The present
invention relates to processes for inserting DNA into eucaryotic cells,
particularly DNA which includes a gene or genes coding for desired proteinaceous
materials for which no selective criteria exist. The insertion of such DNA
molecules is accomplished by cotransforming eucaryotic cells with such DNA
together with a second DNA which corresponds to a gene coding for a selectable
marker. The invention further relates to processes for inserting into
eucaryotic cells a multiplicity of DNA molecules including genes coding for
desired proteinaceous materials by cotransformation with the desired genes and
with amplifiable genes for a dominant selectable marker in the presence of
successively higher amounts of an inhibitor. Alternatively, the insertion of
multiple copies of desired genes is accomplished by transformation using DNA
molecules formed by ligating a DNA molecule including the desired gene to a DNA
molecule which includes an amplifiable gene coding for a dominant selectable
phenotype such as a gene associated with resistance to a drug in the presence
of successively higher amounts of an agent such as a drug against which the
gene confers resistance so that only those eucaryotic cells into which multiple
copies of the amplifiable gene have been inserted survive.


 


7

















 


And at least
the following patent family members:


 


US4634665: Processes for inserting DNA into
eucaryotic cells and for producing proteinaceous materials


 


INVENTORS: Axel R., Wigler M.H., Silverstein S.J..


ASSIGNEES: The Trustees of Columbia University,
New York, NY


ISSUED:
Jan. 6, 1987


FILED: Aug. 11,
1983


SERIAL NUMBER: US1983000522408


 


US4634665: Processes for inserting DNA into
eucaryotic cells and for producing proteinaceous materials


 


INVENTORS: Axel R., Wigler M.H., Silverstein S.J..


ASSIGNEES: The Trustees of Columbia University,
New York, NY


ISSUED:
Jan. 12, 1993


FILED: June 18,
1991


SERIAL NUMBER: US1991000716915


 


TOGETHER WITH
BOSS AND CABILLY II (SEE OVER)


 


8

















 


BOSS PATENT


 


 


	
  Inventors:

  	
   

  	
  Boss,
  Michael Alan; Kenten,John Henry; Emtage, John Spencer; Wood, Clive Ross 

  
	
   

  	
   

  	
   

  
	
  Patentee:

  	
   

  	
  Celltech
  Limited

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
  Multichain
  Polypeptides or Proteins and processes for their production.

  



 


	
  Priority
  Application

  	
   

  	
  Priority
  Date

  
	
   

  	
   

  	
   

  
	
  UK PA
  8308235

  	
   

  	
  25.03.83

  	
   

  



 


	
  Patent Co-operation Treaty (PCT)
  International Publication Number WO 84/03712 designating:

  
	
   

  
	
   

  	
   

  	
  Application
  Number

  	
   

  	
  Date
  of Filing

  
	
   

  	
   

  	
  (Publication
  Number)

  	
   

  	
  (Date
  of Publication)

  
	
  Territory

  	
   

  	
  Patent
  Number

  	
   

  	
  Date
  of Grant

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  United
  Kingdom

  	
   

  	
  8407571

  	
   

  	
  23.03.84

  
	
   

  	
   

  	
  (GB
  2137631A)

  	
   

  	
  (10.10.84)

  
	
   

  	
   

  	
  GB 2137631B

  	
   

  	
  12.11.86

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  International

  	
   

  	
  PCT/GB 84/00094

  	
   

  	
  23.03.84

  
	
  (USA,
  Europe, Japan)

  	
   

  	
  (WO
  84/03712)

  	
   

  	
  (27.09.84)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  USA

  	
   

  	
  672265

  	
   

  	
  23.03.84

  
	
   

  	
   

  	
  (as PCT)

  	
   

  	
  (27.09.84)

  
	
   

  	
   

  	
  4816397

  	
   

  	
  28.03.89

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  USA
  (Divisional)

  	
   

  	
  233430

  	
   

  	
  18.08.88

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Europe

  	
   

  	
   

  	
   

  	
   

  
	
  (Austria,
  West Germany

  	
   

  	
  84301996.9

  	
   

  	
  23.03.84

  
	
  France, Luxembourg,

  	
   

  	
  (EP 0120694)

  	
   

  	
  (03.10.84)

  
	
  Netherlands,
  Sweden,

  	
   

  	
   

  	
   

  	
   

  
	
  Switzerland)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Japan

  	
   

  	
  501609/84

  	
   

  	
  23.03.84

  
	
   

  	
   

  	
  (as PCT)

  	
   

  	
  (27.09.84)

  



 


9

















 


CABILLY II PATENT


 


US6331415: Methods of producing
immunoglobulins, vectors and transformed host cells for use therein


 


INVENTORS: Cabilly;
Shmuel, Heyneker;
Herbert L, Holmes; William E.,


Riggs; Arthur D., Wetzel; Ronald B.


ASSIGNEES: Genentech,
Inc.


ISSUED: Dec. 18, 2001


FILED: June 10, 1988


 


ABSTRACT


 


The invention
relates to processes for producing an immunoglobulin or an immunologically
functional immunoglobulin fragment containing at least the variable domains of
the immunoglobulin heavy and light chains. The processes can use one or more
vectors which produce both the heavy and light chains or fragments thereof in a
single cell. The invention also relates to the vectors used to produce the
immunoglobulin or fragment, and to cells transformed with the vectors.


 


CROSS-REFERENCE TO RELATED APPLICATIONS


 


This
application is a continuation of U.S. patent application Ser. No. 06/483,457,
filed Apr. 8, 1983, now U.S. Pat. No. 4,816,567, issued Mar. 28, 1989.


 


10