Document:

Exhibit
10.22

 

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

 

LICENSE AGREEMENT

 

THIS
LICENSE AGREEMENT (the “Agreement”) is made and entered into as of
November 12, 2002 (the “Effective Date”), by and between Acorda
Therapeutics, Inc., a corporation organized and existing under the laws of the
State of Delaware and having a principal place of business at 15 Skyline Drive,
Hawthorn, New York, USA 10532 (“Acorda”), and CeNeS Pharmaceuticals, PLC, a
corporation organized and existing under the laws of the United Kingdom and
having a principal place of business at Compass House, Vision Park, Chivers
Way, Histon, Cambridge CB4 9ZR, England (“CeNeS”).

 

WHEREAS,
CeNeS is the exclusive licensee of certain intellectual property rights
pursuant to that certain agreement, as amended, entered into by and between the
Ludwig Institute for Cancer Research (“Ludwig”) and Cambridge Neuroscience
Research, Inc. dated October 26, 1989 (the “Ludwig Agreement”);

 

WHEREAS,
CeNeS and Acorda are parties to that certain License Option Agreement dated as
of April 3, 2002, as amended, (the “License Option Agreement”), pursuant
to which CeNeS granted Acorda the option to take a sublicense of certain rights
licensed to CeNeS under the Ludwig Agreement; and

 

WHEREAS,
Acorda desires to exercise such option and to take a sublicense of such rights
as set forth herein,

 

NOW,
THEREFORE, intending to be legally bound and upon the terms, conditions and
mutual covenants hereinafter set forth, the parties agree as follows:

 

 

Part 1 - Definitions

 

1.1                                 “Affiliate” means any corporation, company, partnership,
joint venture and/or firm which controls, is controlled by, or is under common
control with a party to this Agreement. 
As used in this Paragraph, the term “control” means (a) in the case of
corporate entities, -direct or indirect ownership of at least fifty
percent (50%) of the stock or shares having the right to vote for the election
of directors, and (b) in the case of non-corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the equity interest with the power
to direct the management policies of such non-corporate entities.

 

1.2                                 “Licensed Know-How” means all unpatented know-how, trade
secrets, information, data, methods, materials, techniques, reagents, cell
lines, protein sequences or segments, and monoclonal antibodies, including
without limitation, materials as described generally in Schedule B hereto,
owned or controlled by CeNeS at any time during the term of the Agreement that
is necessary or useful to practice the Patent Rights or to research, develop,
make, use or sell Licensed Products.

 

1.3                                 “Licensed Products” means Protein Products and Non-Protein
Products that are covered by one or more Valid Claims under the Patent Rights.

 

1.4                                 “Materials” means the cell lines and related biological
materials that are in CeNeS’ possession or control as of the Effective Date of
this Agreement and are directly related to the production of the protein GGF-2.

 

1.5                                 “NDA” means New Drug Application or a foreign equivalent.

 

1.6                                 “Net Sales” means the amount billed, invoiced, or received
(whichever occurs first) for Sales, leases, or other transfers of Licensed
Products, less:

 

(a)                                  customary
trade, quantity and cash discounts or rebates, and non-affiliated brokers’ or
agents’ commissions actually allowed and taken;

 

2

 

(b)                                 amounts
repaid or credited by reason of rejection, recall or return;

 

(c)                                  to
the extent separately stated on purchase orders, invoices, or other documents
of sale, taxes levied on and/or other governmental charges made as to
production, sale, transportation, delivery or use and paid by Acorda or a
Sublicensee; and

 

(d)                                 reasonable
charges for freight, packaging and insurance costs incurred in the delivery or
transportation of Licensed Products provided by third parties, if separately
stated.

 

Net
Sales also includes the fair market value of any non-cash consideration
received by Acorda or Sublicensees for the Sale, lease, or transfer of Licensed
Products.  The fair market value will be
no less than the standard selling price for the applicable Licensed Products,
each unit multiplied by the quantity of such Licensed Products delivered in
exchange for such non-cash consideration.

 

1.7                                 “Non-Protein Product” means a product that is discovered,
identified or developed through the use of material that is claimed or covered
by a Valid Claim in the Patent Rights, as a target in a screening tool or
otherwise, exclusive of Protein Products.

 

1.8                                 “Patent Rights” means the patents and patent applications
listed on Schedule A attached hereto, including without limitation, the
inventions described and/or claimed therein, and any divisionals,
continuations, continuations-in-part (to the extent that a claim of such
continuation-in-part is entitled to the priority date of at least one of the
patents or patent applications identified in Schedule A), patents issuing
thereon and reissues and reexaminations thereof, and any and all foreign
patents and patent applications corresponding thereto, all to the extent that
CeNeS has an ownership or an interest in such Patent Rights.

 

1.9                                 “Phase II Clinical Trial” means one of those trials on
sufficient numbers of subjects that are designed to establish that a
pharmaceutical product is safe and efficacious for its

 

3

 

intended
use, and to define warnings, precautions and adverse reactions that are
associated with the pharmaceutical product in the dosage range to be
prescribed.  A Phase II Clinical Trial
shall be deemed to have commenced upon the date of the first dosing of the first
subject in such trial.

 

1.10                           “Phase III Clinical Trial” means one of those trials on
sufficient numbers of subjects that are designed to establish that a
pharmaceutical product is safe and efficacious for its intended use, and to
define warnings, precautions and adverse reactions that are associated with the
pharmaceutical product in the dosage range to be prescribed, and to support
Regulatory Approval of a pharmaceutical product or label expansion of such
pharmaceutical product.  A Phase III
Clinical Trial shall be deemed to have commenced  upon the date of
the first dosing of the first subject in such trial.

 

1.11                           “Proceeds” means the royalties actually received by Acorda
from its Sublicensees for Net Sales of Licensed Products that are Non-Protein
Products.

 

1.12                           “Protein Product” means a product that is, in whole or in
part, composed of one or more proteins encoded by the growth factor gene GGF-2,
or a fragment thereof, in whatever form including any mutants, analogues,
homologues or derivative forms thereof, that is covered by a Valid Claim in the
Patent Rights.

 

1.13                           “Regulatory Approval” means the approvals, registrations or
authorizations of the United States Food and Drug Administration (the “FDA”) or successor entity, or other applicable regulatory
agency necessary for the manufacture, distribution, use or sale of a
pharmaceutical or diagnostic product in the United States or a foreign
equivalent in a major market country such as the United Kingdom, Canada, Japan
or Germany.

 

1.14                           “Sold” or “Sale” means the
sale, transfer, exchange or other commercial disposition of Licensed Products
by Acorda, its Affiliates or Sublicensees. 
In case of doubt,

 

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Sales of
Licensed Products shall be deemed consummated no later than receipt of payment
from a third party for the applicable transaction involving such Licensed
Product.

 

1.15                           “Sublicense” means a grant by Acorda, either directly or
indirectly (i.e., through multiple tiers of sublicenses) to a third party of a
sublicense to practice any of the rights granted to Acorda hereunder in
accordance with this Agreement.  Such
third party shall be referred to as a “Sublicensee” under this Agreement.

 

1.16                           “Territory” means all countries and territories worldwide.

 

1.17                           “USD” means United States dollars.

 

1.18                           “Valid Claim” means (a) a pending claim of a patent
application within the Patent Rights, which (i) has been pending under
examination for less than seven (7) years, (ii) has been asserted in good
faith, and (iii) has not been abandoned or finally rejected without the
possibility of appeal or refiling; or (b) a claim of an issued, or granted and
unexpired patent within the Patent Rights, which has not been held
unenforceable, unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, which can no longer be appealed (i.e., within
the time allowed for appeal), which has not been rendered unenforceable through
disclaimer or otherwise, which has not been abandoned, or which has not been
lost through an interference proceeding. 
A Valid Claim shall be defined as of each calendar half year ending
June 30 and December 31.

 

Part 2 - License Grant

 

2.1                                 CeNeS
hereby grants to Acorda, and Acorda accepts, an exclusive license under the
Patent Rights and Licensed Know-How to practice the same and to make, have
made, use, import, offer for sale and sell Licensed Products throughout the
Territory during the term of this Agreement.

 

5

 

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

 

2.2                                 Acorda
hereby acknowledges that CeNeS is obligated to pay Ludwig certain royalties
with respect to Sales by Acorda and Acorda hereby agrees to be amenable to suit
by Ludwig in the event of non-payment of royalties due CeNeS hereunder by
Acorda.  If Ludwig is required to bring
suit against Acorda for any material breach of this Agreement that remains
uncured pursuant to Section 9.3(a), Acorda will pay all reasonable
out-of-pocket costs incurred by Ludwig in connection therewith, including
without limitation, reasonable attorneys fees and costs.

 

2.3                                 Acorda
shall have the right to grant sublicenses to third parties with respect to any
rights conferred upon Acorda under this Part 2, provided, however, that any
sublicense shall be subject in all respects to the conditions (e.g., payment),
restrictions, exceptions and termination provisions contained in this
Agreement.  Acorda shall provide written
notice to CeNeS within sixty(60) days of the grant of any sublicense in
accordance with this Section 2.3.

 

Part 3 - Royalties

 

3.1                                 Acorda
shall pay to CeNeS a non-refundable license fee in the sum of [**] within ten
(10) days after the Effective Date of this Agreement.

 

3.2                                 For
the license granted to Acorda hereunder, Acorda shall pay CeNeS the following
running royalties:

 

(a)                                  Acorda
shall pay to CeNeS the following running royalty based on annual Net Sales of
Protein Products by Acorda or its Affiliates:

 

	
  Annual
  Net Sales in USD

  	
   

  	
  Royalty Rate

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  

 

6

 

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.

 

(b)                                 If
Acorda is required to pay a running royalty to a third party for a license to
make, use, offer for sale, sell or import any Protein Product, then Acorda
shall have the right to offset up to [**] of such royalties actually paid to
such third party against royalties otherwise due under the foregoing Paragraph
3.2(a); provided, however, that such right of offset shall be limited such that-the
royalty due under Paragraph 3:2(b) shall not be less than [**] of annual Net
Sales of Protein Products and provided further that the amount of the offset
which is not available due to such [**] cap cannot be carried-forward for
application against future royalties due under Paragraph 3.2(a).

 

(c)                                  In
the event a Licensed Product is sold in the form of a combination product
containing one or more active ingredients in addition to the Licensed Product
active ingredient (hereinafter “Combination Licensed Product”), then Net Sales
for such Combination Licensed Product, for purposes of calculating royalties
due hereunder, will be adjusted by multiplying actual Net Sales of such
Combination Licensed Product by the applicable fraction, determined as follows:

 

(i)                                     Unless
Section 3.2(c)(ii), 3.2(c)(iii) or 3,2(c)(iv) applies below, the fraction
A/(A+B) where A is the invoice price of the Licensed Product, if sold
separately, and B is the sum of the invoice price(s) of any other active
component or components in the combination, if sold separately.

 

(ii)                                  If,
on a country-by-country basis, the other active component or components in the
Combination Licensed Product are not sold separately in said country, the

 

7

 

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

 

fraction shall be A/C where A is the invoice price of
the Licensed Product if sold separately, and C is the invoice price- of the
Combination Licensed Product.

 

(iii)                               If,
on country by-country basis, the Licensed Product is not sold separately in
said country, the fraction shall be [1-(B/C)] where B is the invoice price sum
of any other active components or components in the combination, if sold
separately and C is the invoice price of the Combination Licensed Product.

 

(iv)                              If,
on a country-by-country basis, neither the Licensed Product nor the other
active component or components of the Combination Licensed Product is sold
separately in said country, the fraction shall be negotiated in good faith by
the parties with the intention of agreeing upon a fair and equitable formula
that reasonably reflects the relative value contributed by the Licensed Product
to the total value of the combination in the Combination; Licensed
Product, as compared to the other active ingredients therein.

 

(d)                                 Acorda
shall pay to CeNeS a royalty of [**] of annual Net Sales of Protein Products by
Sublicensees.

 

(e)                                  Acorda
shall pay to CeNeS a royalty of [**] of annual Net Sales by Acorda of
Non-Protein Products, and [**] of the Proceeds actually received by Acorda from
its Sublicensees on their Sales of Non-Protein Products.

 

(f)                                    Minimum
Annual Royalty.  To the extent that
cumulative annual royalties paid to CeNeS with respect to each Licensed Product
during any calendar year, commencing with the third calendar year following
first commercial sale of any Licensed Product, are less than [**], a minimum
annual royalty with respect to such Licensed Product in the amount of such
shortfall shall be payable by Acorda.  If
Acorda fails to pay any such minimum royalty for a Licensed Product, CeNeS
shall have the option of converting the

 

8

 

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

 

license
or any sublicense granted hereunder with respect to such Licensed Product to a
nonexclusive license by giving Acorda written notice thereof.

 

3.3                                 Acorda
shall pay to CeNeS the following non-refundable milestone payments for every
Protein Product in respect of which Acorda, an Affiliate or Sublicensee
achieves any or all of the milestone events indicated below.  Should a Protein Product be abandoned by
Acorda, Its Affiliate or Sublicensee for any reason following completion of any
of the first five milestones but prior to the Approval of a NDA and Acorda
commences development of a subsequent Protein Product, then Acorda shall resume
the milestone payments for such subsequent Protein Product starting at the
event subsequent to the event for which a milestone payment had already been
paid.  Each such milestone payment shall
be paid within thirty (30) days of the achievement of the relevant milestone
event.  For clarity, each milestone
payment shall be paid only once for each Protein Product and Acorda shall pay
milestones on a Protein Product only if its active pharmaceutical ingredient
(the “API”), is different from the API of any other Protein Product for which
Acorda has already made milestone payments.

 

	
  Milestone
  Event

  	
   

  	
  Milestone Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Satisfactory
  completion of animal toxicology studies necessary to enter into Phase I
  clinical studies in accordance with the International Conference of
  Harmonization (ICH) guidelines provided by the US Food and Drug
  Administration*

  	
   

  	
  $

  	
  [**]

  	
   

  
	
  Issuance
  of an Investigational New Drug Application (or foreign equivalent**)

  	
   

  	
  $

  	
  [**]

  	
   

  
	
  Enrollment
  of the first subject in a Phase II clinical trial (or foreign equivalent**)

  	
   

  	
  $

  	
  [**]

  	
   

  
	
  Enrollment
  of the first subject in a Phase III clinical trial (or foreign equivalent**)

  	
   

  	
  $

  	
  [**]

  	
   

  
	
  Filing
  of a New Drug Application (or foreign equivalent**)

  	
   

  	
  $

  	
  [**]

  	
   

  
	
  Approval
  of a New Drug Application (or foreign equivalent**)

  	
   

  	
  $

  	
  [**]

  	
   

  

 

*            “Completion
of animal toxicology studies” shall mean the completion of all analysis of data
generated in such study and delivery of the final report thereon.

 

**     “Foreign
equivalent” shall mean the completion of the milestones in a foreign major
market country such as the United Kingdom, Japan, Germany, Canada, etc.

 

9

 

3.4                                 (a)                                  All
amounts due hereunder shall be payable in United States Dollars.  Royalty payments shall be made within sixty
(60) days following the end of each calendar quarter.  Each such payment shall include royalties
which shall have accrued during the calendar quarter immediately preceding and
shall be accompanied by a report setting forth separately the Net Sales of all
Licensed Products sold during said calendar quarter.  Any royalty payment required to be made to
CeNeS under Paragraph 3.2(e) shall be made in U.S. Dollars on or before
January 31st of following the calendar year to which such payment relates.

 

(b)                                 Royalties
shall be payable only once (at the highest -applicable rate) with
respect to the same unit of Licensed Product regardless of the number of claims
of Patent tights pertaining to same. 
Royalties shall apply to any Sale of Licensed Product to, a
third party from which Acorda, its Affiliate or Sublicensee derives
revenue.  On any transfer or disposal of
Licensed Product among Acorda, its Affiliates or Sublicensees, royalties shall
become payable only upon further transfer to a third party.

 

(c)                                  The
remittance of royalties payable on the Net Sales of Licensed Product outside
the U.S. shall be made to CeNeS in U.S. Dollars a the official rate of exchange
of the currency of the country from which the royalties are payable (as quoted
by Citibank N.A. for the last business day of the calendar quarter in which the
royalties are payable) less any withholding or transfer taxes which are
applicable.  Acorda or a Sublicensee
shall supply CeNeS with proof of payment of such taxes paid on CeNeS’s behalf and
shall cooperate with CeNeS in obtaining credit or refund of any such taxes.

 

10

 

(d)                                 No
royalties for Sales outside the U.S. shall be payable with respect to any Sales
as to which conversion cannot be made of the currency billed in U.S. Dollars
until such conversion can be legally made, at which time royalties shall be
paid in U.S. Dollars at the rate of exchange quoted by Citibank, N.A., for the
business day immediately preceding the date on which the restriction on
conversion was lifted.  However, CeNeS
shall have the right to have the royalties payable by Acorda, its Affiliates or
Sublicensees deposited in CeNeS’s name in the blocked currency in an interest
bearing account in a bank designed by CeNeS in the foreign country in
question.  In the event CeNeS cannot
arrange to have the blocked currency transferred out of the foreign country
within twelve (12) months after deposit, CeNeS shall notify Acorda in writing
and Acorda shall as soon as possible thereafter cause such royalties (plus
earnings thereon during the period of deposit) to be paid to CeNeS in U.S.
Dollars at the rate of exchange quoted by Citibank, N.A. on the day the blocked
currency was deposited in the bank designated by CeNeS.  Upon receipt of the payment, CeNeS shall
release to Acorda from the bank in the foreign country in question the blocked
currency in accordance with Acorda’s instructions.

 

(e)                                  Acorda,
its Sublicensees and Affiliates shall keep and maintain records of sales of
Licensed Products for a period of three (3) years after the royalty period to
which such records relate.  Such records
shall be open to inspection upon at least fifteen (15) business days’ prior
written notice at any reasonable time during normal business hours not more
often than once each calendar quarter by an independent Certified Public
Accountant selected by CeNeS, to whom Acorda or, if applicable, its Affiliates
or Sublicensees, have no reasonable objection, who shall have the right to
examine and make abstracts of the records kept pursuant to this Agreement and
report findings of said examination of records to CeNeS insofar as it is
necessary to evidence any mistake or impropriety on the part of Acorda.  Said independent Certified Public Accountant

 

11

 

shall
treat as confidential and shall not use or disclose to any third party any
information acquired during the course of such examination, except information
which shall be made available to CeNeS or Ludwig pursuant to any provision of
this Agreement.

 

(f)                                    Acorda’s
obligation to pay royalties with respect to Net Sales of Licensed Product in my
country shall continue for so long as CeNeS owns or holds exclusive rights to a
valid and enforceable issued patent within the Patent Rights covering such
Licensed Product in Such country.  If
Acorda’s obligation to pay royalties is based solely on the practice of the
Patent Rights to discover or develop a Non-Protein Product, said obligation
shall continue until fifteen (15) years from the Effective Date of this
Agreement.

 

Part 4 - Patent Matters

 

4.1                                 Upon
execution of this Agreement, Acorda shall assume responsibility and control, at
its expense, during the Term for the preparation, filing, prosecution and
maintenance of any and all patent applications and patents included in Patent
Rights.  Notwithstanding the previous
sentence, Acorda shall furnish to CeNeS copies of all material documents
pertaining to such preparation, filing, prosecution or maintenance, including
filings and correspondence with patent authorities, in a timely manner, so as
to give CeNeS an opportunity to comment thereon and Acorda shall use good faith
efforts to accommodate any such comments.

 

4.2                                 Ludwig,
CeNeS, and Acorda shall cooperate fully in the preparation, filing, prosecution
and maintenance of Patent Rights and of all patents and patent applications
licensed to Acorda hereunder, executing all papers and instruments or requiring
members of Ludwig and/or CeNeS to execute such papers and instruments so as to
enable Acorda to apply for, to prosecute and to maintain patent applications
and patents in Ludwig’s name in any country. 
Each party shall provide to the other prompt notice as to all matters
which come to its attention

 

12

 

and
which may affect the preparation, filing, prosecution or maintenance of any
such patent applications or patents.

 

4.3                                 Acorda
may elect to surrender its rights under the Patent Rights on a patent-by-patent
basis in any country upon sixty (60) days written notice to CeNeS.  CeNeS may elect thereafter to continue
prosecution and maintenance of such patents at its own expense.

 

Part 5 - Patent Infringement

 

5.1                                 Enforcement
by Acorda.  If either CeNeS or Acorda
becomes aware of a product made, used or sold in the Territory, or any other
activities, which it believes infringes a Valid Claim, the party obtaining such
knowledge shall promptly advise the other patty of all relevant facts and
circumstances pertaining to the potential infringement.  Acorda shall have the first right, but not
the obligation, to enforce any patent rights against such infringement, at its
own expense.  CeNeS and Ludwig shall cooperate
with Acorda in such effort, at Acorda’s expense, including being joined as a
party to such action, if necessary.  Any
damages or costs recovered in connection with any action filed by Acorda
hereunder which exceed Acorda’s out-of-pocket costs and expenses of litigation,
shall be deemed to be Net Sales of Protein Products in the fiscal quarter
received by Acorda, and royalties shall be payable by Acorda to CeNeS thereon
in accordance with the terms of this Agreement.

 

5.2                                 Backup
Enforcement Right by CeNeS.  If Acorda
fails within one hundred twenty (120) days after receiving notice from CeNeS of
a potential infringement, or providing CeNeS with notice of such infringement,
to either (a) terminate such infringement or (b) institute an action to prevent
continuation thereof and, thereafter to prosecute such action diligently, or if
Acorda notifies CeNeS that it does not plan to terminate the infringement or
institute such action, then CeNeS shall have the right to do so at its own
expense; provided however, that CeNeS first

 

13

 

consults
with Acorda and gives due consideration to Acorda’s reasons for not instituting
actions to terminate or otherwise prevent continuation of such
infringement.  If CeNeS decides to pursue
such infringement, Acorda shall cooperate with CeNeS in such effort including
being joined as a party to such action if necessary.  CeNeS shall be entitled to retain all damages
or costs awarded to CeNeS in such action.

 

5.3                                 In
the event that Acorda, its Affiliate or Sublicensee is sued by a third party
charging infringement of a patent resulting from the manufacture, use or sale
by Acorda, its Affiliate or Sublicensee of a Licensed Product, Acorda shall
promptly notify CeNeS.  During the period
in which any such suit is pending, Acorda shall have the right to apply up to
fifty percent (50%) of the royalties due CeNeS against Acorda’s litigation
expenses of any such suit.

 

Part 6 - Diligence

 

6.1                                 Acorda
agrees to use all reasonable efforts to effect introduction of Licensed
Products into the commercial market as soon as practicable, consistent with
sound and reasonable business practices and judgment.

 

Part 7 - Indemnification and
Insurance

 

7.1                                 Acorda
hereby indemnifies CeNeS, Ludwig and their respective directors, officers,
employees and agents (collectively, the “CeNeS Indemnitees”)
and agrees to be solely responsible and to hold CeNeS Indemnitees harmless from
any third party claim, demands, suits or causes of action, including all
judgments, damages, and costs (including reasonable attorneys’ fees) resulting
therefrom, arising out of the use, manufacture, sale, storage or advertising of
any Licensed Product except to the extent of such judgments, damages and costs
that arise from the negligence or willful misconduct of CeNeS Indemnitees.

 

14

 

7.2                                 CeNeS
hereby indemnifies Acorda, its Affiliates, directors, officers, agents,
contractors, Sublicensees and employees (collectively, the “Acorda Indemnitees”) and agrees to be solely responsible and
to hold Acorda Indemnitees harmless from any third party claim demands, suits
or causes of action, including all judgments, damages, and costs (including
reasonable attorneys’ fees) resulting therefrom, arising out of any breach of
Section 8.1 except to the extent of such judgments, damages and costs that
arise from the negligence or willful misconduct of Acorda Indemnitees.

 

7.3                                 To
be eligible to be indemnified hereunder, the indemnified party shall provide
the indemnifying party with prompt notice of the claim giving rise to the indemnification
obligation pursuant to this Part 7 and the exclusive ability to defend (with
the reasonable cooperation of the indemnified party) or settle any such claim; provided, however, that the indemnifying party shall not
enter into any-settlement for damages other than monetary damages without the
indemnified party’s written consent, such consent not to be unreasonably
withheld or delayed.  The indemnified
party shall have the right to participate, at its own expense and with counsel
of its choice, in the defense of any claim or suit that has been assumed by the
indemnifying party.

 

7.4                                 Prior
to commencing human use of any Licensed Product hereunder, Acorda shall obtain
and maintain thereafter comprehensive general liability insurance (to include
advertisers’ liability and product liability) written by a reputable insurer or
insurers approved by CeNeS and shall list CeNeS as an additional named insured
thereunder and shall require thirty (30) days written notice to be given to
CeNeS prior to any cancellation or material change thereof.  The limits for such insurance shall not be
less than ten million dollars (USD 10,000,000) per occurrence for personal
injury and property damage, adjusted for inflation every year based on

 

15

 

the U.S.
Consumer Price Index in effect on the first day of such year.  Acorda shall provide CeNeS with certificates
of insurance evidencing the same upon written request by CeNeS.

 

Part 8 - Representations and
Warranties

 

8.1                                 CeNeS
Representations and Warranties.  CeNeS
represents and warrants that:

 

(a)                                  its
obligations under this Agreement are not in conflict with any prior commitments
or obligations to any third party; that it has all requisite power and
authority to enter into this Agreement; and that all corporate action necessary
to authorize its execution and delivery of this Agreement has been duly taken;

 

(b)                                 it
has the right to grant the rights granted in this Agreement and perform the
obligations set forth herein;

 

(c)                                  it
and its Affiliates have not granted to any third party any license, option or
other rights under the Patent Rights, and to its knowledge, the Ludwig License
is in full force and effect;

 

(d)                                 to
its knowledge, there are no facts or circumstance which would render any of the
Patent Rights invalid or unenforceable;

 

(e)                                  to
its knowledge, there is no interference action, opposition, reissue or
reexamination proceeding, or any intellectual property litigation pending
before any patent office or court concerning any of the Patent Rights; and

 

(f)                                    Cambridge
Neuroscience Research, Inc. has assigned all its rights and obligations in the
Ludwig Agreement to CeNeS.

 

8.2                                 Acorda
Representations and Warranties.  Acorda
represents and warrants that its obligations under this Agreement are not in
conflict with any prior commitments or obligations to any third party; that it
has all requisite power and authority to enter into this Agreement; and

 

16

 

that all
corporate action necessary to authorize its execution and delivery of this
Agreement has been duly taken.

 

Part 9 - Term and Early
Termination

 

9.1                                 Unless
sooner terminated as herein provided, this Agreement shall continue in full
force and effect commencing on the Effective bate of this Agreement and
continuing until the later of fifteen (15) years thereafter or the expiration
of the last-to-expire Valid Claim in the Patent Rights.

 

9.2                                 Acorda
may terminate this Agreement at any time for any reason, upon thirty (30) days
prior written notice to CeNeS.

 

9.3                                 (a)                                  A
party may terminate this Agreement and the license herein granted upon the
breach of any material obligation herein by the other party upon sixty (60)
days written notice; provided that if during such sixty (60) day period the
party so notified cures such material breach, then this Agreement shall
continue in full force and effect.

 

(b)                                 If
this Agreement is terminated as provided in Paragraphs 9.2 or 9.3(a), Acorda
shall promptly make an accounting to CeNeS of the inventory of Licensed
Products which it and its Affiliates and Sublicensees have on hand as of the
effective date of such termination, if applicable.  Acorda, its Affiliates and Sublicensees shall
then have the right, for a period of six (6) months after said termination, to
sell such inventory provided that the Net Sales thereof shall be subject to the
royalty rates payable to CeNeS as set forth above.

 

9.4                                 The
license to Acorda set forth in Section 2.1 shall continue after any
termination or expiration of this Agreement as set forth in this
Section 9.4.  If this Agreement
expires pursuant to Section 9.1, then Acorda shall thereafter retain a
nonexclusive, perpetual, royalty-free, worldwide license, with the full right
to sublicense, under the Patent Rights and Licensed

 

17

 

Know-How
to practice such technology and rights for all purposes.  If this Agreement is terminated by Acorda
pursuant to Section 9.3, then Acorda, in its sole discretion, may elect to
retain the exclusive license granted in Section 2.1, subject to the
payment of the royalties otherwise due under Section 3.2.

 

Part 10 - Confidentiality

 

10.1                           Treatment
of Confidential Information.  Except as
otherwise provided hereunder, during the term of this Agreement and for a
period of five (5) years thereafter:

 

(a)                                  CeNeS,
its Affiliates and Sublicensees shall retain in confidence and use only for
purposes of this Agreement, any written information and data supplied by Acorda
to CeNeS under this Agreement and marked as proprietary or confidential; and

 

(b)                                 Acorda
shall retain in confidence and use only for purposes of this Agreement, any
written information and data supplied by CeNeS to Acorda under this Agreement
and marked as proprietary or confidential.

 

For purposes
of this Agreement, all such information and data which a party is obligated to
retain in confidence shall be called “Information.”  Any written information, materials or data
relating to GGF-2 disclosed by one party to the other party pursuant to the
License Option Agreement and the Confidentiality Agreement entered into as of
July 23, 2001 shall be deemed Information under this Agreement.

 

10.2                           Permitted
Disclosure.  To the extent that it is
reasonably necessary to fulfill its obligations or exercise its rights under
this Agreement, or any rights which survive termination or expiration hereof,
each party may disclose Information to its Affiliates, sublicensees,
consultants, outside contractors and clinical investigators on condition that
such entities or persons agree:

 

18

 

(a)                                  to
keep the Information confidential for at least the same time periods and to the
same extent as each party is required to keep the Information confidential and

 

(b)                                 to
use the Information only for such purposes as such parties are authorized to
use the Information.

 

Each
party, its Affiliates or sublicensees may disclose Information to regulatory
authorities to the extent that such disclosure is necessary for the prosecution
and enforcement of patents, authorizations to conduct clinical trials or
commercialization of Licensed Products, provided that such party is otherwise
entitled to engage in such activities under this Agreement.  Each party, its Affiliates or sublicensees
may disclose Information to the government or a court of competent
jurisdiction, provided that such disclosing party (a) provides the other party
with adequate notice of the required disclosure, (b) cooperates with the other
party’s efforts to protect its Information with respect to such disclosure and
(c) takes all reasonable measures requested by the other party to challenge or
to modify the scope of such required disclosure.  CeNeS may disclose Information to Ludwig to
the extent such disclosure is required pursuant to CeNeS’ obligations under the
Ludwig Agreement.

 

10.3                           The
obligation under Section 10.1 not to use or disclose Information shall not
apply to any part of such Information that the recipient party can establish by
competent written proof:

 

(a)                                  is
or becomes patented, published or otherwise part of the public domain, other
than by unauthorized acts of the party obligated not to disclose such
Information (for purposes of this Part 10 (the “Receiving
Party”), its Affiliates or Sublicensees in contravention of this
Agreement;

 

19

 

(b)                                 is
disclosed to the Receiving Party, its Affiliates or Sublicensees by a third
party provided that such Information was not obtained by such third party
directly or indirectly from the other party under this Agreement;

 

(c)                                  prior
to disclosure under this Agreement, was already in the possession of the
Receiving Party, its Affiliates or Sublicensees, provided that such Information
was not obtained directly or indirectly from the other patty under this
Agreement;

 

(d)                                 results
from the research and development by the Receiving Party, its Affiliates or
Sublicensees, independent of disclosures from the other party of this
Agreement, provided that the persons developing such information have not had
exposure to the Information received from the disclosing party; or

 

(e)                                  CeNeS
and Acorda agree in writing may be disclosed.

 

10.4                           Confidential
Nature of the Terms of Agreement.  Except
as expressly provided herein, CeNeS and Acorda each agrees not to disclose any
terms of this Agreement to any third party without the consent of the other
party; provided, however, that disclosures may be made as required by
securities or other applicable laws, or to actual or prospective investors or
corporate partners, or to a party’s accountants, attorneys, and other
professional advisors who agree to appropriate confidentiality provisions to
protect such terms from disclosure or improper use.

 

Part 11 - General Provisions

 

11.1                           Except
as required by law, neither CeNeS nor Acorda shall originate any publicity,
news release, or other public announcement, written or oral, whether to the
public press, to stockholders, or otherwise, relating to this Agreement to any
amendment thereto or to performance hereunder or the existence of an
arrangement between the parties without the prior written approval of the other
party, not to be unreasonably withheld; provided that, no such

 

20

 

consent
shall be required for non-public communications between Acorda and its current,
or potential stockholders, investors, acquiring parties, merger partners or
Sublicensees.  Acorda shall not use the
name Ludwig, or CeNeS (or any variant thereof) or any related organization in
any advertising, packaging (except for customary technical references) or other
promotional material in connection with the sale of Licensed Products referred
to in this Agreement.

 

11.2                           Acorda
acknowledges that it has certain duties and obligations under Part 379 of the
Export Administration Regulations of the U.S. Department of Commerce (as
presently promulgated or hereafter modified or amended) concerning the export
and reexport of technical data.  Acorda
will be solely responsible for any breach of such Regulations by Acorda, its
Affiliates or Sublicensees and will defend and hold Indemnitees harmless in the
event of a suit or action involving any such breach.

 

11.3                           Neither
party may assign or transfer this Agreement or any rights or obligations
hereunder without the prior written consent of the other, such consent not to
be unreasonably withheld, and except that a party may make such an assignment
without the other party’s consent to an Affiliate or to a successor to all, or
substantially all, of the business and assets to which this Agreement relates
of such party, whether in a merger, sale of stock, sale of assets or other
transaction of the division or divisions of Acorda involved in the development
and sale of Licensed Products.  Any
permitted successor or assignee of rights and/or obligations hereunder shall,
in a writing to the other party, expressly assume performance of such rights
and/or obligations.  Any permitted
assignment shall be binding on the successor of the assigning party.

 

11.4                           All
notices required to be given by one party to the other hereunder shall be
sufficient if signed by such party (or such party’s attorney) and either:  (a) delivered in person; (b) mailed certified
mail, postage prepaid, return receipt requested; or (b) faxed to the other
party

 

21

 

provided
that the sender receives acknowledgement that such notice has been received by
the party to be notified and promptly sends the original by ordinary mail; in
any event, to the following addresses:

 

	
  If to Acorda:

  
	
   

  
	
   

  	
  Acorda Therapeutics,
  Inc,

  
	
   

  	
  15 Skyline Drive

  
	
   

  	
  Hawthorne, NY 10532

  
	
   

  	
  Attn: President and
  Chief Executive Officer

  
	
   

  	
   

  
	
  with a copy to:

  
	
   

  	
   

  
	
   

  	
  Acorda Therapeutics,
  Inc.

  
	
   

  	
  15 Skyline Drive

  
	
   

  	
  Hawthorne, NY 10532

  
	
   

  	
  Attn: Harold Safferstein,
  Vice President, Business Development

  
	
   

  	
   

  
	
  If to CeNeS:

  
	
   

  	
   

  
	
   

  	
  CeNeS Pharmaceuticals
  plc

  
	
   

  	
  Compass House

  
	
   

  	
  Vision Park

  
	
   

  	
  Clovers Way

  
	
   

  	
  Histon, Cambridge CI4
  9ZR

  
	
   

  	
  England

  
	
   

  	
  Attn: Neil Clark, Chief
  Operating Officer and Finance Director

  

 

By
such notice either party may change their address for future notices.  Notices delivered in person shall be deemed
given on the date delivered.  Notices
sent by fax shall be deemed given on the date faxed.  Notices mailed shall be deemed given two (2)
days after the date postmarked on the envelope.

 

11.5                           This
Agreement constitutes the entire agreement between the parties and supersedes
all written or oral prior agreements or understandings with respect to the
subject matter hereof except that any confidential information disclosed
pursuant to the License Option

 

22

 

Agreement
shall be deemed Information of this Agreement. 
No variation or modification of the terms or provisions of this
Agreement shall be valid unless in writing and signed by the patties hereto.

 

11.6                           No
right or license is granted by CeNeS under this Agreement to Acorda, or by
Acorda to CeNeS, either expressly or by implication, except those specifically
set forth herein.

 

11.7                           Waiver
by Acorda or CeNeS of any single default or breach or succession of defaults or
breaches by the other shall not deprive CeNeS or Acorda of any right to
terminate this Agreement arising out of any subsequent default or breach nor
shall it be construed as a waiver of either party’s rights thereafter to
enforce each and every provision of this Agreement.

 

11.8                           All
matters affecting the interpretation, validity, and performance of this
Agreement shall be governed by the laws of the State of New York applicable to
agreements made and to be performed wholly within New York, but the scope and
validity of Patent Rights shall be governed by the applicable laws of the
country granting the patent in question.

 

11.9                           Acorda’s
relationship with CeNeS shall be that of a licensee only.  Neither party shall be considered to be an
employee or agent of the other, nor shall this Agreement constitute, create or
in any way be interpreted as a joint venture, partnership or formal business
organization of any kind.  In that
respect, neither party shall have the authority to execute any agreement on
behalf of the other party, nor shall either party have any authority to
negotiate any agreement, except as the other party may expressly direct in
writing.

 

11.10                     Parts 7, 8,
and 10 and Sections 9.3(b), 9.4 and 11.10 shall survive termination of this
Agreement for any reason.

 

11.11                     This
Agreement may be executed in one or more counterparts, each of which shall be
deemed an original, but all of which shall constitute one and the same
instrument.

 

23

 

11.12                     The captions
herein are solely for convenience of reference and shall not affect the
construction or interpretation of this Agreement.

 

IN
WITNESS WHEREOF, CeNeS and Acorda have caused this Agreement to be executed in
duplicate by their respective duty authorized officers.

 

 

	
  CeNeS
  PHARMACEUTICALS, PLC

  	
  ACORDA
  THERAPEUTICS, INC.

  
	
   

  	
   

  
	
  By:

  	
  /s/ Neil Clark

  	
   

  	
  By:

  	
  /s/ Harold T.
  Safferstein

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Print Name:

  	
  Neil Clark

  	
   

  	
  Print Name:

  	
  Harold T.
  Safferstein

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Finance Director

  	
   

  	
  Title:

  	
  VP Business
  Development

  	
   

  
												

 

24

 

SCHEDULE A

 

PATENT RIGHTS

 

Granted Patent List

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Patent

  Number

  	
   

  	
  Grant

  Date

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002AU5

  	
   

  	
  Australia

  	
   

  	
  688270

  	
   

  	
  02-Jul-1998

  	
   

  	
  29-Jun-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002AU6

  	
   

  	
  Australia

  	
   

  	
  709968

  	
   

  	
  23-Dec-1999

  	
   

  	
  25-May-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002AUX

  	
   

  	
  Australia

  	
   

  	
  703772

  	
   

  	
  15-Jul-1999

  	
   

  	
  09-Oct-1996

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002EP1

  	
   

  	
  Europe

  	
   

  	
  0579640

  	
   

  	
  24-Jul-2002

  	
   

  	
  03-Apr-1992

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002KR1

  	
   

  	
  Korea

  	
   

  	
  274305

  	
   

  	
  08-Sep-2000

  	
   

  	
  03-Apr-1992

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002KR5

  	
   

  	
  Korea

  	
   

  	
  307943

  	
   

  	
  25-Aug-2001

  	
   

  	
  29-Jun-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002KR6

  	
   

  	
  Korea

  	
   

  	
  265928

  	
   

  	
  09-Jun-2000

  	
   

  	
  25-May-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002KR7

  	
   

  	
  Korea

  	
   

  	
  297680

  	
   

  	
  24-May-2001

  	
   

  	
  25-May-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002KR8

  	
   

  	
  Korea

  	
   

  	
  344006

  	
   

  	
  28-Jun-2002

  	
   

  	
  29-Jun-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002PT1

  	
   

  	
  Portugal

  	
   

  	
  100344

  	
   

  	
  02-May-1999

  	
   

  	
  03-Apr-1992

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002PT5

  	
   

  	
  Portugal

  	
   

  	
  101297

  	
   

  	
  07-Jul-1999

  	
   

  	
  30-Jun-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002005

  	
   

  	
  United States

  	
   

  	
  5,530,109

  	
   

  	
  25-Jun-1996

  	
   

  	
  24-Mar-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002006

  	
   

  	
  United States

  	
   

  	
  5,716,930

  	
   

  	
  10-Feb-1998

  	
   

  	
  26-May-1994

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002007

  	
   

  	
  United States

  	
   

  	
  5,621,081

  	
   

  	
  15-Apr-1997

  	
   

  	
  06-Jun-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  

 

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Patent

  Number

  	
   

  	
  Grant

  Date

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002009

  	
   

  	
  United States

  	
   

  	
  5,606,032

  	
   

  	
  25-Feb-1997

  	
   

  	
  06-Jun-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J. Goodearl
  et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200A

  	
   

  	
  United States

  	
   

  	
  5,792,849

  	
   

  	
  11-Aug-1998

  	
   

  	
  06-Jun-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200G

  	
   

  	
  United States

  	
   

  	
  5,602,096

  	
   

  	
  11-Feb-1997

  	
   

  	
  06-Jun-1995

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200J

  	
   

  	
  United States

  	
   

  	
  6,204,241

  	
   

  	
  20-Mar-2001

  	
   

  	
  22-Oct-1996

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200L

  	
   

  	
  United States

  	
   

  	
  6,194,377

  	
   

  	
  27-Feb-2001

  	
   

  	
  22-Oct-1996

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200P

  	
   

  	
  United States

  	
   

  	
  5,854,220

  	
   

  	
  29-Dec-1998

  	
   

  	
  22-Oct-1996

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002ZA1

  	
   

  	
  South Africa

  	
   

  	
  92/2001

  	
   

  	
  25-Nov-1992

  	
   

  	
  01-Apr-1992

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002ZA5

  	
   

  	
  South Africa

  	
   

  	
  93/4711

  	
   

  	
  31-Aug-1994

  	
   

  	
  30-Jun-1993

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-039AU1

  	
   

  	
  Australia

  	
   

  	
  713384

  	
   

  	
  16-Mar-2000

  	
   

  	
  27-Mar-1996

  	
   

  	
  Granted

  	
   

  	
  Thomas A. Reh et
  al.

  
	
  Title:  METHODS OF TREATING DISORDERS OF THE EYE

  

 

	
  Matter

  Number

  	
   

  	
  Patent

  Country

  	
   

  	
  Grant

  Number

  	
   

  	
  Grant

  Date

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-04AU1

  	
   

  	
  Australia

  	
   

  	
  707599

  	
   

  	
  28-Oct-1999

  	
   

  	
  16-Nov-1995

  	
   

  	
  Granted

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  
	
  04585-041001

  	
   

  	
  United States

  	
   

  	
  6,087,323

  	
   

  	
  11-Jul-2000

  	
   

  	
  17-Nov-1994

  	
   

  	
  Granted

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title: USE OF
  NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION

  
	
   

  
	
  04585-043AU2

  	
   

  	
  Australia

  	
   

  	
  727037

  	
   

  	
  15-Mar-2001

  	
   

  	
  12-Nov-1996

  	
   

  	
  Granted

  	
   

  	
  Mark Marchionni
  et al.

  
	
  Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL
  SENSORY EPITHELIA

  
	
   

  
	
  04585-048AU2

  	
   

  	
  Australia

  	
   

  	
  745324

  	
   

  	
  21-Mar-2002

  	
   

  	
  08-Oct-1998

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF A
  NEUREGULIN

  
	
   

  
	
  04585-051001

  	
   

  	
  United States

  	
   

  	
  5,594,114

  	
   

  	
  14-Jan-1997

  	
   

  	
  17-Aug-1992

  	
   

  	
  Granted

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  SCHWANN CELL MITOGENIC FACTOR, ITS
  PREPARATION AND USE

  

 

2

 

Pending
Patent Application List

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Application

  Number

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002CA1

  	
   

  	
  Canada

  	
   

  	
  2,108,199

  	
   

  	
  03-Apr-1992

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002CA5

  	
   

  	
  Canada

  	
   

  	
  2,139,136

  	
   

  	
  29-Jun-1993

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002CA6

  	
   

  	
  Canada

  	
   

  	
  2,191,085

  	
   

  	
  25-May-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002CN6

  	
   

  	
  China

  	
   

  	
  95 1 9320X

  	
   

  	
  25-May-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002EP5

  	
   

  	
  Europe

  	
   

  	
  93 918139.2

  	
   

  	
  29-Jun-1993

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002EP6

  	
   

  	
  Europe

  	
   

  	
  95922145.8

  	
   

  	
  25-May-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002IE1

  	
   

  	
  Ireland

  	
   

  	
  921062

  	
   

  	
  03-Apr-1992

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002MX6

  	
   

  	
  Mexico

  	
   

  	
  965812

  	
   

  	
  25-May-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002PH5

  	
   

  	
  Philippines

  	
   

  	
  44157

  	
   

  	
  03-Apr-1992

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002008

  	
   

  	
  United States

  	
   

  	
  08/470,339

  	
   

  	
  06-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200E

  	
   

  	
  United States

  	
   

  	
  08/469,549

  	
   

  	
  06-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200F

  	
   

  	
  United States

  	
   

  	
  08/471,833

  	
   

  	
  06-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200H

  	
   

  	
  United States

  	
   

  	
  08/472,065

  	
   

  	
  06-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200I

  	
   

  	
  United States

  	
   

  	
  08/734,665

  	
   

  	
  22-Oct-1996

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200M

  	
   

  	
  United States

  	
   

  	
  08/735,010

  	
   

  	
  13-May-1999

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J. Goodearl
  et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  

 

3

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Application

  Number

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200N

  	
   

  	
  United States

  	
   

  	
  08/736,070

  	
   

  	
  22-Oct-1996

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200Q

  	
   

  	
  United States

  	
   

  	
  08/736,019

  	
   

  	
  22-Oct-1996

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-00200R

  	
   

  	
  United States

  	
   

  	
  08/734,592

  	
   

  	
  22-Oct-1996

  	
   

  	
  Pending

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002WO1

  	
   

  	
  PCT

  	
   

  	
  GB92/00595

  	
   

  	
  03-Apr-1992

  	
   

  	
  Natl Phase

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002WO5

  	
   

  	
  PCT

  	
   

  	
  US93/06228

  	
   

  	
  29-Jun-1993

  	
   

  	
  Natl Phase

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-002WO6

  	
   

  	
  PCT

  	
   

  	
  US95/06846

  	
   

  	
  25-May-1995

  	
   

  	
  Natl Phase

  	
   

  	
  Andrew D.J.
  Goodearl et al.

  
	
  Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION
  AND USE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-028001

  	
   

  	
  United States

  	
   

  	
  08/209,204

  	
   

  	
  08-Mar-1994

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-028002

  	
   

  	
  United States

  	
   

  	
  08/461,097

  	
   

  	
  05-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-028004

  	
   

  	
  United States

  	
   

  	
  08/468,731

  	
   

  	
  06-Jun-1995

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-030CA1

  	
   

  	
  Canada

  	
   

  	
  2,162,262

  	
   

  	
  06-May-1994

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-030EP1

  	
   

  	
  Europe

  	
   

  	
  94916690.4

  	
   

  	
  06-May-1994

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-030JP1

  	
   

  	
  Japan

  	
   

  	
  525593/1994

  	
   

  	
  06-May-1994

  	
   

  	
  Pending

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-030WO1

  	
   

  	
  PCT

  	
   

  	
  US94/05083

  	
   

  	
  06-May-1994

  	
   

  	
  Natl Phase

  	
   

  	
  Robert Sklar et
  al.

  
	
  Title:  METHODS FOR TREATING MUSCLE DISEASES AND
  DISORDERS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-039CA1

  	
   

  	
  Canada

  	
   

  	
  2,215,330

  	
   

  	
  27-Mar-1996

  	
   

  	
  Pending

  	
   

  	
  Thomas A. Reh et
  al.

  
	
  Title:  METHODS OF TREATING DISORDERS OF THE EYE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-039EP1

  	
   

  	
  Europe

  	
   

  	
  96910617.8

  	
   

  	
  27-Mar-1996

  	
   

  	
  Pending

  	
   

  	
  Thomas A. Reh et
  al.

  
	
  Title:  METHODS OF TREATING DISORDERS OF THE EYE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-039JP1

  	
   

  	
  Japan

  	
   

  	
  8-529635

  	
   

  	
  27-Mar-1996

  	
   

  	
  Pending

  	
   

  	
  Thomas A. Reh et
  al.

  
	
  Title:  METHODS OF TREATING DISORDERS OF THE EYE

  

 

4

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Application

  Number

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041CA1

  	
   

  	
  Canada

  	
   

  	
  2,204,850

  	
   

  	
  16-Nov-1995

  	
   

  	
  Pending

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041EP1

  	
   

  	
  Europe

  	
   

  	
  95940728.9

  	
   

  	
  16-Nov-1995

  	
   

  	
  Pending

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041JP1

  	
   

  	
  Japan

  	
   

  	
  8-516986

  	
   

  	
  16-Nov-1995

  	
   

  	
  Pending

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041004

  	
   

  	
  United States

  	
   

  	
  09/069,784

  	
   

  	
  20-Mar-2001

  	
   

  	
  Pending

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041005

  	
   

  	
  United States

  	
   

  	
  09/366,886

  	
   

  	
  04-Aug-1999

  	
   

  	
  Pending

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-041WO1

  	
   

  	
  PCT

  	
   

  	
  US95/14974

  	
   

  	
  16-Nov-1995

  	
   

  	
  Natl Phase

  	
   

  	
  David I. Gwynne
  et al.

  
	
  Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR
  COMMUNICATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-043CA2

  	
   

  	
  Canada

  	
   

  	
  2,237,400

  	
   

  	
  12-Nov-1996

  	
   

  	
  Pending

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL
  SENSORY EPITHELIA

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-043EP2

  	
   

  	
  Europe

  	
   

  	
  96940360.9

  	
   

  	
  12-Nov-1996

  	
   

  	
  Pending

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL
  SENSORY EPITHELIA

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-043JP2

  	
   

  	
  Japan

  	
   

  	
  518966/97

  	
   

  	
  12-Nov-1996

  	
   

  	
  Pending

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL
  SENSORY EPITHELIA

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-043WO2

  	
   

  	
  PCT

  	
   

  	
  US96/18031

  	
   

  	
  12-Nov-1996

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL
  SENSORY EPITHELIA

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044AU2

  	
   

  	
  Australia

  	
   

  	
  49744/00

  	
   

  	
  20-Apr-2000

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044CA2

  	
   

  	
  Canada

  	
   

  	
  2,368,357

  	
   

  	
  20-Apr-2000

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044EP2

  	
   

  	
  Europe

  	
   

  	
  00931938.5

  	
   

  	
  20-Apr-2000

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044JP2

  	
   

  	
  Japan

  	
   

  	
  2000-613391

  	
   

  	
  20-Apr-2000

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044KR2

  	
   

  	
  Korea

  	
   

  	
  2001-7013409

  	
   

  	
  20-Apr-2000

  	
   

  	
  Natl Phase

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044001

  	
   

  	
  United States

  	
   

  	
  09/298,121

  	
   

  	
  23-Apr-2000

  	
   

  	
  Pending

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  

 

5

 

	
  Matter

  Number

  	
   

  	
  Country

  	
   

  	
  Application

  Number

  	
   

  	
  Filing

  Date

  	
   

  	
  Status

  	
   

  	
  Inventors

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-044WO2

  	
   

  	
  PCT

  	
   

  	
  US00/10664

  	
   

  	
  20-Apr-2000

  	
   

  	
  Published

  	
   

  	
  Mark Marchionni
  et al..

  
	
  Title:  METHODS OF TREATING CONGESTIVE HEART
  FAILURE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048CA2

  	
   

  	
  Canada

  	
   

  	
  2,306,228

  	
   

  	
  08-Oct-1998

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048EP2

  	
   

  	
  Europe

  	
   

  	
  98949803.5

  	
   

  	
  08-Oct-1998

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048JP2

  	
   

  	
  Japan

  	
   

  	
  2000-515608

  	
   

  	
  08-Oct-1998

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048KR2

  	
   

  	
  Korea

  	
   

  	
  2000-7003972

  	
   

  	
  08-Oct-1998

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048002

  	
   

  	
  United States

  	
   

  	
  09/530,884

  	
   

  	
  29-Aug-2000

  	
   

  	
  Natl Phase

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04585-048WO2

  	
   

  	
  PCT

  	
   

  	
  US98/21349

  	
   

  	
  18-Oct-1998

  	
   

  	
  Pending

  	
   

  	
  R. McBurney et
  al.

  
	
  Title:  THERAPEUTIC METHODS COMPRISING USE OF
  NEUREGULIN

  

 

6Exhibit
10.23

 

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

 

LICENSE AGREEMENT

 

This License Agreement
(the “AGREEMENT”) is entered into this 12th day of November, 2002 (the
“EFFECTIVE DATE”), by and between CeNes Pharmaceuticals, plc, a corporation
organized and existing under the laws of the United Kingdom and having a
principal place of business at Compass House, Vision Park, Chivers Way, Histon,
Cambridge CB4 9ZR, England (hereinafter “CeNeS”) and Acorda Therapeutics, Inc.,
a corporation organized and existing under the laws of the State of Delaware
and having a principal place of business at 15 Skyline Drive, Hawthorne,
NY  10532 (hereinafter “Acorda” or
“LICENSEE”).

 

WHEREAS, CeNeS, by its
acquisition of Cambridge NeuroScience, Inc., has exclusive rights under that
certain license agreement, as amended, (the “Harvard License”) by and between
Cambridge NeuroScience, Inc. and President and Fellows of Harvard College
(“Harvard”), acting on its behalf and, pursuant to an inter-institutional
agreement (the “Inter-Institutional Agreement”), acting on behalf of the Leland
Stanford Junior College (“STANFORD”) pursuant to which Harvard licensed certain
rights to Cambridge NeuroScience, Inc.;

 

WHEREAS, CeNeS and Acorda
are parties to that certain license option agreement, as amended, pursuant to
which CeNeS granted an option to Acorda to, among other things, obtain a
sublicense of the rights granted by Harvard to Cambridge NeuroScience, Inc.
pursuant and subject to the Harvard License (the “LICENSE OPTION AGREEMENT”)

 

WHEREAS, Acorda desires
to exercise such option and to acquire a sublicense of such rights as set forth
herein; and

 

WHEREAS, CeNeS desires to
grant a sublicense of such rights as set forth herein.

 

NOW THEREFORE, in
consideration of the foregoing premises and of other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties hereby agree as follows:

 

ARTICLE I

DEFINITIONS

 

As used in this
AGREEMENT, the terms below shall have the following meanings:

 

1.1           “AFFILIATE” means any
corporation, company, partnership, joint venture and/or firm that controls, is
controlled by, or is under common control with either party.  As used in this Paragraph, the term “control”
means (a) in the case of corporate entities, direct or indirect ownership of at
least fifty percent (50%) of the stock or shares having the right to vote for
the election of directors, and (b) in the case of non-corporate entities,
direct or indirect ownership of at least fifty percent (50%) 

 

 

of the equity interest
with the power to direct the management policies of such non-corporate
entities.

 

1.2           “BIOLOGICAL MATERIALS”
means the materials identified in Appendix B, attached hereto, together with
any progeny, mutants, or derivatives thereof which are either supplied by CeNeS
or are created by LICENSEE and are covered by a VALID CLAIM.

 

1.3           “IND” means an
Investigational New Drug application as defined in the US. Food, Drug and
Cosmetics Act and the regulations promulgated thereunder.

 

1.4           “LICENSED KNOW-HOW”
means all unpatented know-how, trade secrets, information, data, methods,
materials, techniques, reagents, cell lines, protein sequences or segments, and
monoclonal antibodies, including without limitation, materials as described
generally in Appendix C hereto, owned or controlled by CeNeS at any time during
the term of the AGREEMENT that is necessary or useful to practice the PATENT
RIGHTS or to research, develop, make, use or sell LICENSED PRODUCTS.

 

1.5           “LICENSED PRODUCTS”
means: (a) PROTEIN PRODUCTS and NON-PROTEIN PRODUCTS that are covered by one or
more VALID CLAIM(S) under the PATENT RIGHTS and (b) PROTEIN PRODUCTS and
NON-PROTEIN PRODUCTS that incorporate some portion of BIOLOGICAL MATERIALS.

 

1.6           “NDA” means a New Drug
Application as defined in the U.S. Food, Drug and Cosmetics Act and the
regulations promulgated thereunder.

 

1.7           “NET SALES” means the
amount billed, invoiced, or received (whichever occurs first) for SALES, leases
or other transfers of LICENSED PRODUCTS, less:

 

(a)           customary trade,
quantity and cash discounts or rebates and non-affiliated brokers’ or agents’
commissions actually allowed and taken;

 

(b)           amounts repaid or
credited by reason of rejection, recall or return;

 

(c)           to the extent
separately stated on purchase orders, invoices, or other documents of sale, tax
levied on and/or other governmental charges made as to production, sale,
transportation, delivery or use and paid by LICENSEE or a SUBLICENSEE; and

 

(d)           reasonable charges for
freight, packaging and insurance costs incurred in the delivery of
transportation or LICENSED PRODUCTS provided by third parties, if separately
stated.

 

NET SALES also includes
the fair market value of any non-cash consideration received by LICENSEE or
SUBLICENSEES for the SALE, lease, or transfer of LICENSED PRODUCTS.

 

2

 

1.8           “NON-COMMERCIAL
RESEARCH PURPOSES” means the use of PATENT RIGHTS and/or BIOLOGICAL MATERIALS
for academic research or other not-for-profit scholarly purposes which are
undertaken at a non-profit or governmental institution that does not use the PATENT
RIGHTS and/or BIOLOGICAL MATERIALS in the production of manufacture of products
for sale or the performance of services for a fee.  Such use shall not include (i) the right to
use the subject matter of the PATENT RIGHTS in the production or manufacture of
products for sale or for the performance of services for a fee, or (ii) the
right to use the subject matter of the PATENT RIGHTS pursuant to a research
funding or other agreement or collaboration with a third party entity as a
consequence of which such third party entity is granted rights to commercialize
products or services under the PATENT RIGHTS.

 

1.9           “NON-PROTEIN PRODUCTS”
means products that are discovered, identified or developed through the use of
material that is claimed or covered by a VALID CLAIM in the PATENT RIGHTS, as a
target in a screening tool or otherwise, exclusive of PROTEIN PRODUCTS.

 

1.10         “PATENT RIGHTS” means the
patents and patent applications listed on Appendix A attached hereto, including
without limitation United States Serial No. 08/525,864, filed September 9,
1995, now United States Patent No. 5,912,326, along with the inventions
described and/or claimed therein, and any divisionals, continuations,
continuations-in-part (to the extent that a claim of such continuation-in-part
is entitled to the priority date of at least one of the patents, applications,
or disclosures identified in Appendix A), patents issuing thereon and reissues
and reexaminations thereof, and any and all foreign patents and patent
applications corresponding thereto, all to the extent that Harvard and/or
STANFORD has an ownership or an interest in such PATENT RIGHTS.

 

1.11         “PROCEEDS” means the
royalties actually received by Acorda from its SUBLICENSEES for NET SALES of
LICENSED PRODUCTS that are NON-PROTEIN PRODUCTS.

 

1.12         “PROTEIN PRODUCT” means a
product that is in whole or in part, composed of one or more proteins encoded
by the growth factor gene nrg-2, or a
fragment thereof, in whatever form including mutants, analogues, homologues or
derivative forms thereof, that is covered by a VALID CLAIM in the PATENT
RIGHTS.

 

1.13         “PUBLIC LAWS” means the
US laws referred to as “Public Law 96-517” and “Public Law 98-620” and includes
all amendments to such statutes.

 

1.14         “SOLD” and “SALE” means
the sale, transfer, exchange or other commercial disposition of LICENSED
PRODUCTS by LICENSEE, its AFFILIATES or SUBLICENSEES.  In case of doubt, SALES of LICENSED PRODUCTS
shall be deemed consummated no later than receipt of payment from a third party
for the applicable transaction involving such LICENSED PRODUCT.

 

3

 

1.15         “SUBLICENSE” means a
grant by LICENSEE, either directly or indirectly (i.e., through multiple tiers
of sublicenses) to a third party of sublicense to practice any of the rights
granted to LICENSEE hereunder in accordance with this AGREEMENT.  Such third party shall be referred to as a
“SUBLICENSEE” under this AGREEMENT.

 

1.16         “TERRITORY” means all
countries and territories worldwide.

 

1.17         ‘VALID CLAIM” means (a) a
pending claim of a patent application within the PATENT RIGHTS, which (i) has
been pending under examination for less than seven (7) years, (ii) has been
asserted in good faith, and (iii) has not been abandoned or finally rejected
without the possibility of appeal or refiling; or (b) a claim of an issued or
granted and unexpired patent within the PATENT RIGHTS, which has not been held
unenforceable unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, which can no longer be appealed (i.e., within
the time allowed or appeal), which has not been rendered, unenforceable through
disclaimer or otherwise, which has not been abandoned, or which has not been
lost through an interference proceeding. 
A VALID CLAIM shall be defined as of each calendar half year ending
June 30 and December 31.

 

ARTICLE II

Grant of Rights

 

2.1           CeNeS hereby grants to
LICENSEE and LICENSEE accepts, subject to the terms an conditions hereof, an
exclusive sublicensee under the PATENT RIGHTS and LICENSED KNOW-HOW in the
TERRITORY to make and have made, use and have used, sell, offer for sale, have
sold and import LICENSED PRODUCTS for the life of the PATENT RIGHTS.  Such sublicense shall include the right to
grant further sublicenses through multiple tiers of sublicenses.

 

2.2           The granting and
exercise of this license is subject to the following conditions:

 

(a)           Harvard’s “Statement of
Policy in Regard to Inventions, Patents and Copyrights,” dated August 10,
1998 the PUBLIC LAWS, the Harvard’s obligations under the sponsored research
agreement(s) referenced as Grant Nos. EY08397 and NS14506 from the National
Institutes of Health.  Any right granted
in this AGREEMENT greater than that permitted under the PUBLIC LAWS shall be
subject to modification as may be required to conform to the provisions of
those statutes.

 

(b)           Harvard’s reservation
of the right to make and use, and to grant to not-for-profit third parties,
non-exclusive licenses to use the subject matter described and claimed in the
PATENT RIGHTS solely where the rights conferred by such non-exclusive license
are explicitly limited to use that is for NON-COMMERCIAL RESEARCH PURPOSES, provided, that, in all such non-exclusive licenses granted
under this paragraph 2.2(b),

 

4

 

Harvard shall include
such limitation of use as provided in subparagraphs 2.9(i) and 2.9(ii) of the
Harvard License, as amended.

 

(c)           LICENSEE shall use its
best efforts to bring the subject matter of this AGREEMENT into commercial use
as quickly as is reasonably possible. 
This AGREEMENT is subject and subordinate to the terms and conditions of
the Harvard License.

 

(d)           For as long as the
sublicense rights granted in this AGREEMENT remain exclusive in the United
States, LICENSEE shall cause any LICENSED PRODUCT produced for sale in the
United States to be manufactured substantially in the United States.

 

2.3           All rights reserved to
the United States Government and others under the Public Laws shall remain and
shall in no way be affected by this AGREEMENT.

 

ARTICLE III

Diligence

 

3.1           LICENSEE shall, itself
or through its AFFILIATES or SUBLICENSEES, use diligent efforts to effect
introduction of LICENSED PRODUCTS into the commercial market as soon as
practicable, consistent with sound and reasonable business practice and
judgment; thereafter, until the expiration of this Agreement, LICENSEE shall
endeavor to keep LICENSED PRODUCTS reasonably available to the public.  LICENSEE, its AFFILIATES or SUBLICENSEES
shall make such efforts in the form of the actions (a) - (d) of this
Section 3.1 (hereinafter referred to as “Diligence Milestones”).

 

(a)           within twenty-four (24)
months of the EFFECTIVE DATE, commence exploratory studies leading to the
validation of a specific therapeutic area of use for the growth factor gene nrg-2, therapeutic study areas may include, but are not
limited to, central nervous system indications, congestive heart failure and
cardiotoxicity secondary to chemotherapy with tyrosine kinase anti-neoplastic
agents, and submit to CeNeS a due diligence report describing the exploratory
studies;

 

(b)           within fifty-four (54)
months of the EFFECTIVE DATE, file an IND for a LICENSED PRODUCT and shall
provide written notice to CeNeS of such filing;

 

(c)           within eighty-four (84)
months of the EFFECTIVE DATE, initiate human clinical trials for a LICENSED
PRODUCT and shall provide written notice to CeNeS of such initiation; and

 

(d)           within one hundred
twenty (120) months of the EFFECTIVE DATE, file a NDA for a LICENSED PRODUCT.

 

5

 

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

 

3.2           In the event of a
failure by LICENSEE, its AFFILIATES or SUBLICENSEES to meet a Diligence
Milestone set forth above, and LICENSEE can demonstrate to CeNeS that it has
made reasonable efforts to meet such milestone, CeNeS and LICENSEE shall
negotiate in good faith and agree upon a reasonable extension for such
milestone; provided that such extension shall be no less than twelve (12)
months.  Additional extensions to the
same Diligence Milestone may be granted, if needed, based upon the progress
that has been made by LICENSEE to meet the unmet Diligence Milestone.

 

ARTICLE IV

Royalties

 

4.1           LICENSEE shall pay to
CeNes a non-refundable license royalty fee in the sum of [**] within ten (10)
days after execution date of this AGREEMENT.

 

4.2           (a)           LICENSEE shall pay to CeNeS during the term
of this AGREEMENT a royalty of [**] of NET SALES of PROTEIN PRODUCTS by
LICENSEE and its AFFILIATES and a royalty of [**] of the NET SALES of PROTEIN
PRODUCTS by each SUBLICENSEE.

 

(b)           LICENSEE shall pay to
CeNeS during the term of this AGREEMENT a royalty of [**] of NET SALES of
NON-PROTEIN PRODUCTS by LICENSEE or its AFFILIATES.  In the case of SUBLICENSES, LICENSEE shall
pay to CeNeS [**] of PROCEEDS received by LICENSEE from each such SUBLICENSEE
in connection with NON-PROTEIN PRODUCTS.

 

(c)           The obligation to pay
royalties to CeNeS under this AGREEMENT shall be imposed only once with respect
to the same unit of LICENSED PRODUCT regardless of the number of pending or
issued claims of the PATENT RIGHTS covering the applicable LICENSED PRODUCT or
the amount of subject matter of the PATENT RIGHTS used in the development,
manufacture or use thereof.

 

(d)           LICENSEE shall not be
obligated to make any further royalty payments in a country for any LICENSED
PRODUCT after the end of the period commencing on the date of the first
commercial sale of the LICENSED PRODUCT in such country by LICENSEE, its
AFFILIATEs or SUBLICENSEEs and ending on the date of expiration of the last
VALID CLAIM of the PATENT RIGHTS covering the LICENSED PRODUCT actually used to
make such LICENSED PRODUCT, in such country.

 

4.3           In the event a LICENSED
PRODUCT is sold in the form of a combination product containing one or more
active ingredients in addition to the LICENSED PRODUCT active ingredient (hereinafter
“COMBINATION LICENSED PRODUCT”), then the applicable NET SALES for such
COMBINATION

 

6

 

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.

 

LICENSED PRODUCT, for
purposes of calculating royalties due thereunder, will be adjusted by
multiplying actual NET SALES of such COMBINATION LICENSED PRODUCT by the
applicable fraction, determined as follows:

 

(a)           Unless
Section 4.3(b), 4.3(c) or 4.3(d) applies below, the fraction A/(A+B) where
A is the invoice price of the LICENSED PRODUCT, if sold separately, and B is
the sum of the invoice price(s) of any other active component or components in
the combination, if sold separately.

 

(b)           If, on a
country-by-country basis, the other active component or components in the
COMBINATION LICENSED PRODUCT are not sold separately in said country, the
fraction shall be A/C where A is the invoice price of the LICENSED PRODUCTS if
sold separately, and C is the invoice price of the COMBINATION LICENSED
PRODUCT.

 

(c)           If, on
country-by-country basis, the LICENSED PRODUCT is not sold separately in said
country, the fraction shall be [1-(B/C)] where B is the invoice price sum of
any other active components or components in the combination, if sold
separately and C is the invoice price of the COMBINATION LICENSED PRODUCT.

 

(d)           If, on a
country-by-country basis, neither the LICENSED PRODUCT nor the other active
component or components of the COMBINATION LICENSED PRODUCT is sold separately
in said country, the fraction shall be negotiated in good faith by the parties
with the intention of agreeing upon a fair and equitable formula that
reasonably reflects the relative value contributed by the LICENSED PRODUCT to
the total value of the combination in the COMBINATION LICENSED PRODUCT, as
compared to the other active ingredients therein.

 

4.4           For SALES between
LICENSEE and its AFFILIATEs or SUBLICENSEEs for resale, the royalty shall be
paid once on the NET SALEs of such resale to a third party by the AFFILIATE or
SUBLICENSEE.

 

4.5           No later than
January 1 of each calendar year after the EFFECTIVE DATE of this
AGREEMENT, LICENSEE shall pay to CeNeS the following non-refundable license
maintenance royalty and/or advance on royalties.  Such payments may be credited against the
royalties due for that calendar year and Royalty Reports (as defined in
Section 5.3(a)) shall reflect such a credit.  Such payments shall not be creditable against
royalties due for any subsequent calendar year. 
The first three (3) of such payments shall not be creditable against milestone
payments but subsequent payments thereafter may be creditable against milestone
or royalty payments.

 

	
  January 1,
  2003

  	
   

  	
  $

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  January 1,
  2004

  	
   

  	
  $

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  January 1,
  2005

  	
   

  	
  $

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  January 1
  of each additional year prior to the first to occur of (i) the termination
  date of this AGREEMENT; or (ii) expiration of the PATENT RIGHTS

  	
   

  	
  $

  	
  [**]

  	
   

  

 

7

 

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

 

4.6           LICENSEE shall pay to
CeNeS the following non-refundable milestone payments upon achievement by
LICENSEE, an AFFILIATE or SUBLICENSEE of the milestone events indicate below:

 

(a)           Upon the EFFECTIVE DATE:  $[**];

 

(b)           Upon initiation of the
first human clinical trial of a LICENSED PRODUCT that is a PROTEIN
PRODUCT:  $[**];

 

(c)           Upon initiation of the
first Phase III human clinical trial of a LICENSED PRODUCT that is a PROTEIN
PRODUCT:  $[**];

 

(d)           Upon filing the first
New Drug Application (“NDA”) with the U.S. Food and Drug Administration for a
LICENSED PRODUCT that is a PROTEIN PRODUCT: 
$[**];

 

(e)           Upon being granted the
first approval to market commercially a LICENSED PRODUCT that is a PROTEIN PRODUCT
in the United States:  $[**]; and

 

(f)            Upon being granted the
first approval to market commercially a LICENSED PRODUCT that is a PROTEIN
PRODUCT in a country chosen from the group consisting of the United State,
Canada, the United Kingdom, France, Germany, Italy, Spain, and Japan:  $[**]. 
For avoidance of doubt, in the event the first approval to market
commercially a LICENSED PRODUCT that is a PROTEIN PRODUCT occurs in the United
States, then LICENSEE shall nevertheless be obligated to pay both milestones
(e) and (f) for a total payment of $[**] in connection with such approval.

 

For clarity, should a
PROTEIN PRODUCT be abandoned by LICENSEE, its AFFILIATE or SUBLICENSEE for any
reason following completion of any of milestones (b) through (e) but prior to
completion of milestone (f), and LICENSEE commences development of a subsequent
PROTEIN PRODUCT, then LICENSEE shall resume the milestone payments for such
subsequent PROTEIN PRODUCT starting at the event subsequent to the event for
which a milestone payment had already been paid.  Each milestone payment shall be paid only
once by LICENSEE.

 

8

 

ARTICLE V

REPORTING

 

5.1           Diligence Milestones
shall be reported according to the provisions of Section 3.1 of this
AGREEMENT.

 

5.2           LICENSEE shall report
to CeNeS the date of first Sale of each LICENSED PRODUCT in each country within
thirty (30) days of occurrence.

 

5.3           (a)           LICENSEE shall submit to CeNeS within sixty
(60) days after each calendar half year ending June 30 and
December 31, a royalty report (“Royalty Report”) setting forth for such
half year at least the following information:

 

(i)                  the
number of LICENSED PRODUCTS sold by Licensee, its AFFILIATES And SUBLICENSEEs
in each country;

 

(ii)                 total
billings for such LICENSED PRODUCTS;

 

(iii)                deduction
applicable to determine the NET SALES thereof;

 

(iv)                the
amount of NET SALES by SUBLICENSEEs and PROCEEDS received by LICENSEE; and

 

(v)                 the
amount of royalty due thereon, or, if no royalties are due to CeNeS for any
reporting period, the statement that no royalties are due.

 

Each such Royalty Report
shall be certified as correct by an officer of LICENSEE to the best of such
officer’s knowledge, and shall include a detailed listing of all deductions
from royalties.

 

(b)           LICENSEE shall pay to
CeNeS with each such Royalty Report the amount of royalty due with respect to
such half year.  If multiple technologies
are covered by the license granted thereunder, LICENSEE shall specify which
PATENT RIGHTS are practiced for each LICENSED PRODUCT included in the Royalty
Report.

 

(c)           All payments due
hereunder shall be deemed received when funds are credited to CeNeS’s bank
account and shall be payable by check or wire transfer in United States
dollars.  Conversion of foreign currency
to U.S. dollars shall be made at the conversion rate existing in the United
States (as reported the Wall Street Journal, Eastern Edition) on the last
working day of each royalty period.  No
transfer, exchange, collection or other charges shall be deduced from such
payments.

 

(d)           All such reports shall
be considered trade secrets of LICENSEE, and shall be maintained in confidence
by CeNeS, except solely as required by law or by the terms of the Harvard
License.

 

(e)           Late payments shall be
subject to a charge of one and one-half percent (1.5%) per month, or $250,
whichever is greater.

 

9

 

ARTICLE VI

Record Keeping

 

6.1           LICENSEE shall keep,
and shall require its AFFILIATEs and SUBLICENSEEs to keep, accurate records
(together with supporting documentation) of LICENSED PRODUCTS made, used or
sold under this AGREEMENT, appropriate to determine the amount of royalties due
to CeNeS hereunder.  Such records shall
be retained for at least three (3) years following the end of the reporting
period to which they relate.  They shall
be available upon at least fifteen (15) business days’ prior written notice at
any reasonable time during normal business hours not more often than once each
calendar quarter for examination by an independent accountant selected by
CeNeS, to whom Acorda or, if applicable, its AFFILIATEs or SUBLICENSEEs, have
no reasonable objection, for the sole purpose of verifying reports and payments
hereunder.  In conducting examinations
pursuant to this Section, CeNeS’ independent accountant shall have access to
all records that CeNeS reasonably believes to be relevant to the calculation of
royalties under Article IV.  Such
independent accountant an CeNeS shall treat as confidential and shall not use
or disclose to any third party (except Harvard and STANFORD) any information
acquired during the course of such examination.

 

6.2           Such examination by
CeNeS’s independent accountant shall be at CeNeS’ expense, except that if such
an examination shows an underreporting or underpayment in excess of five
percent (5%) for any twelve (12) month period, then LICENSEE shall pay the cost
of such examination as well as any additional sum that would have been payable
to CeNeS had the LICENSEE reported correctly, plus interest on said sum at the
rate of one and one-half percent (1.5%) per month.  If the independent account determines that
there had been an overpayment by LICENSEE, LICENSEE shall be entitled to either
a refund in the amount of such overpayment or a credit against any future
payments to be made by LICENSEE under this AGREEMENT.

 

ARTICLE VII

DOMESTIC AND FOREIGN PATENT FILING AND MAINTENANCE

 

7.1           Upon execution of this
AGREEMENT, LICENSEE shall be primarily responsible for the preparation, filing,
prosecution and maintenance of any and all patent applications and patents
included in PATENT RIGHTS, at its expense. 
Notwithstanding the previous sentence, LICENSEE shall promptly furnish
to CeNeS copies of all material documents pertaining to such preparation, filing,
prosecution or maintenance, and CeNeS shall be given and opportunity to consult
with LICENSEE as to the preparation, filing, prosecution and maintenance.

 

7.2           Harvard and LICENSEE
shall cooperate fully in the preparation, filing, prosecution and maintenance
of PATENT RIGHTS and of all patents and patent

 

10

 

applications licensed to
LICENSEE hereunder, executing all papers and instruments or requiring members
of Harvard and/or STANFORD to execute such papers and instruments so as to
enable LICENSEE to apply for, to prosecute and to maintain patent applications
and patents in Harvard’s and STANFORD’s name in each country.  Each party shall provide to the other prompt
notice as to all matters which come to its attention and which may affect the
preparation, filing, prosecution or maintenance of any such patent applications
or patents.

 

7.3           LICENSEE may elect to
surrender its rights under the PATENT RIGHTS on a patent-by-patent basis in any
country upon sixty-(60) days written notice to CeNeS.

 

ARTICLE VIII

ENFORCEMENT AND DEFENSE OF THE PATENT RIGHTS

 

8.1           With respect to any
PATENT RIGHTS that are exclusively licensed to LICENSEE pursuant to this
AGREEMENT, LICENSEE shall have the right to prosecute and defend its own name
and at its own expense any infringement of a patent within PATENT RIGHTS, or
any other type of litigation involving the subject matter of the PATENT
RIGHTS.  CeNeS agrees to notify LICENSEE
promptly of each infringement of such patents of which CeNeS is or becomes
aware, and of each challenge to such patents of which CeNeS is or becomes
aware.

 

8.2           (a)           If LICENSEE commences an action In
accordance with Section 8.1 above, Harvard may to the extent permitted by
law, and shall to the extent required by law so as to enable LICENSEE to
enforce the exclusive rights granted to it by this AGREEMENT, join as a part in
that action. Regardless of whether Harvard joins as a party, both Harvard and
CeNeS shall cooperate fully with LICENSEE in connection with any such action.

 

(b)           If Harvard elects to
join as a party pursuant to Section 8.2(a), Harvard shall jointly control
the action with LICENSEE.

 

(c)           LICENSEE shall
reimburse Harvard for any costs Harvard incurs, including reasonable attorneys’
fees, as part of an action brought by LICENSEE, whether or not Harvard becomes
a party to such action.

 

8.3           If LICENSEE elects to
commence an action as described above, LICENSEE may deduct from its royalty
payments to CeNeS with respect to the patent(s) subject to suit an amount not
exceeding fifty percent (50%) of LICENSEE’s expenses and costs of such action,
including reasonable attorney’s fees and any reimbursements provided for under
Section 8.2(c); provided, however, that such reduction shall not exceed
fifty percent (50%) of the total royalty due to CeNeS with respect to the
patent(s) subject to suit for each calendar year.  If such fifty percent (50%) of LICENSEE’s
expenses and costs exceeds the amount of royalties deducted by LICENSEE for any
calendar year, LICENSEE may to that extent reduce the

 

11

 

royalties due to CeNeS
from LICENSEE in succeeding calendar years, but never by more than fifty
percent (50%) of the total royalty due in any one year with respect to the
patent subject to suit.

 

8.4           No settlement, consent
judgment or other voluntary final disposition of the suit may be entered into
without the prior written consent of Harvard, and without the prior written
consent of LICENSEE,  which consent shall
not be unreasonably withheld by either of them.

 

8.5           Recoveries or
reimbursements, from actions commenced pursuant to this Article VIII shall
be distributed as follows: (i) each party shall first be reimbursed for any
expenses and litigation costs incurred in the action (including any
reimbursement provided by LICENSEE to Harvard pursuant to Section 8.2(c)
to the extent not deducted from royalties pursuant to Section 8.3) and
then to reimburse CeNeS for royalties deducted by LICENSEE pursuant to in Section 8.3;
(ii) as to any remaining ordinary damages, LICENSEE shall deem such remaining
damages as NET SALES in the fiscal quarter receives by LICENSEE and royalties
on such amount shall be payable by LICENSEE to CeNeS accordingly; and (iii) as
to any remaining special or punitive damages, LICENSEE shall receive an amount
equal to 50% of its external expenses incurred in the action and the remainder
of such special or punitive award shall be shared equally between the parties.

 

8.6           If LICENSEE elects not
to exercise its right to prosecute an infringement of the . PATENT RIGHTS
pursuant to this Article VIII within one hundred twenty (120) days after
notification by CeNeS pursuant to Section 8.1 of any such infringement,
CeNeS may do so at its own expense, controlling such action and retaining all
recoveries therefrom. Notwithstanding the foregoing, CeNeS shall first consult
with LICENSEE and give due consideration to LICENSEE’s reasons for not
instituting actions to prosecute an infringement of the PATENT RIGHTS. If CeNeS
decides to pursue such infringement, LICENSEE shall cooperate fully with CeNeS
in connection with any such action.

 

8.7           If a declaratory
judgment action is brought naming LICENSEE as a defendant and alleging
invalidity of any of the PATENT RIGHTS, CeNeS may elect to join such action at
its own expense; in all other respects such action shall be conducted as if it
had been brought by LICENSEE pursuant to Sections 8.1, 8.2, 8.3 and 8.4 of this
Article VIII.

 

ARTICLE IX

TERMINATION OF AGREEMENT

 

9.1           This AGREEMENT, unless
earlier terminated as provided herein, shall remain in effect until the last
patent, patent application, or claim included in PATENT RIGHTS has expired,
been abandoned or been held finally rejected or invalid (the “TERM”).

 

12

 

9.2           Except as provided in
paragraphs 9.3(a) and 9.3(b) below, either party shall have the right to
terminate this AGREEMENT if the other party defaults in the performance of a
material obligation under this AGREEMENT and the default has not been remedied
within ninety (90) days after the date of notice in writing of such default by
the party specifying such breach and seeking termination.

 

9.3           CeNeS may terminate
this AGREEMENT immediately under the following circumstances:

 

(a)           If LICENSEE defaults in
its obligations under Sections 11.6(a) and 11.6(b), provided, that CeNeS
provides written notice to LICENSEE of the default and LICENSEE fails to cure
such default within thirty (30), days; or

 

(b)           if CeNeS determines
that the AGREEMENT should be terminated due to the failure of LICENSEE to meet
a Diligence Milestone by the expiration of an extension pursuant to
Section 3.2, and if, in CeNeS’ reasonable judgment, a further extension
pursuant to Section 3.2 would be unlikely to result in LICENSEE being able
to meet such Diligence Milestone.

 

9.4           If Harvard terminates
the Harvard License because CeNeS becomes insolvent, makes an assignment for
the benefit of creditors, or has a petition in bankruptcy filed for or against
it, Harvard shall, upon LICENSEE’s written request, enter into a direct license
with LICENSEE for the PATENT RIGHTS under the same terms as those in this
AGREEMENT.

 

9.5           This AGREEMENT shall,
at LICENSEE’s written request, be assigned to Harvard upon termination of the
Harvard License. CeNeS shall provide prompt written notice to LICENSEE if
Harvard gives notice that it intends to terminate the Harvard License for
breach, and LICENSEE may engage in actions to cure such breach to avoid such
termination or else may effect an assignment of this AGREEMENT to Harvard upon
termination of the Harvard License.

 

9.6           LICENSEE shall have the
right to terminate this AGREEMENT upon ninety (90) days advance written notice
of termination to CeNeS, such termination to be effective on the last of such
ninety (90) days (the “Termination Date”). 
LICENSEE shall submit a final Royalty Report to CeNeS, and pay any and
all amounts due hereunder, including, without limitation, all royalty payments
and unreimbursed patent expenses, within thirty (30) days following the
Termination Date.

 

9.7           The license to LICENSEE
set forth in Section 2.1 shall continue after any termination or
expiration of this AGREEMENT as set forth in this Section 9.7.  If this AGREEMENT expires pursuant to
Section 9.1, then LICENSEE shall thereafter retain a nonexclusive,
perpetual, royalty-free, worldwide license, with the full right to sublicense,
under the PATENT RIGHTS and LICENSED KNOW-HOW to practice such technology and
rights for all purposes. If this

 

13

 

AGREEMENT is terminated
by LICENSEE pursuant to Section 9.2, then LICENSEE, in its sole
discretion, may elect to retain the exclusive license granted in
Section 2.1, subject to the payment of the royalties otherwise due under
Section 4.2.

 

9.8           Articles I and X, and
Sections 2.3, 5.3(e), 9.7, 9.8, 11.1, 11.2, 11.4, 11.5, 11.7 and 11.9 of this
AGREEMENT shall survive termination.

 

ARTICLE X

CONFIDENTIALITY

 

10.1         Treatment of Confidential
Information.  Except as otherwise
provided hereunder, during the term of this AGREEMENT and for a period of five
(5) years thereafter:

 

(a)           CeNeS, its AFFILIATES
and SUBLICENSEES shall retain in confidence and use only for purposes of this
AGREEMENT, any written information and data supplied by LICENSEE to CeNeS under
this AGREEMENT and marked as proprietary or confidential; and

 

(b)           LICENSEE shall retain
in confidence and use only for purposes of this AGREEMENT, any written
information and data supplied by CeNeS to LICENSEE under this AGREEMENT and
marked as proprietary or confidential.

 

For purposes of this
AGREEMENT, all such information and data which a party is obligated to retain
in confidence shall be called “Information.”  Any written information, materials or data
relating to NRG-2 disclosed by one party to the other party pursuant to the
LICENSE OPTION AGREEMENT and the Confidentiality Agreement entered into as of
July 23, 2001 shall be deemed Information under this AGREEMENT.

 

10.2         Permitted Disclosure. To
the extent that it is reasonably necessary to fulfill its obligations or
exercise its rights under this AGREEMENT, or any rights which survive
termination or expiration hereof, each party may disclose Information to its
AFFILIATES, SUBLICENSEES, consultants, outside contractors and clinical
investigators on condition that such entities or persons agree:

 

(a)           to keep the Information
confidential for at least the same time periods and to the same extent as each
party is required to keep the Information confidential and

 

(b)           to use the Information
only for such purposes as such parties are authorized to use the Information.

 

Each party, its
AFFILIATES or SUBLICENSEES may disclose Information to regulatory authorities
to the extent that such disclosure is necessary for the prosecution and
enforcement of patents, authorizations to conduct clinical trials or
commercialization of LICENSED PRODUCTS, provided that such party is

 

14

 

otherwise entitled to engage in such activities under this
AGREEMENT. Each party, its AFFILIATES or SUBLICENSEES may disclose Information
to the government or a court of competent jurisdiction, provided that such
disclosing party (a) provides the other party with adequate notice of the
required disclosure, (b) cooperates with the other party’ s efforts to protect
its Information with respect to such disclosure and (c) takes all reasonable
measures requested by the other party to challenge or to modify the scope of
such required disclosure. CeNeS may disclose Information to Harvard and
Stanford to the extent such disclosure is required pursuant to CeNeS’ s
obligations under the Harvard License.

 

10.3         The obligation under
Section 10.1 not to use or disclose Information shall not apply to any
part of such Information that the recipient party can establish by competent
written proof:

 

(a)           is or becomes patented,
published or otherwise part of the public domain, other than by unauthorized
acts of the party obligated not to disclose such Information (for purposes of this
Article 10 (the “Receiving Party”),
its AFFILIATES or SUBLICENSEES in contravention of this AGREEMENT;

 

(b)           is disclosed to the
Receiving Party, its AFFILIATES or SUBLICENSEES by a third party provided that
such Information was not obtained by such third party directly or indirectly
from the other party under this AGREEMENT;

 

(c)           prior to disclosure
under this AGREEMENT, was already in the possession of the Receiving Party, its
AFFILIATES or SUBLICENSEES, provided that such Information was not obtained directly
or indirectly from the other party under this AGREEMENT;

 

(d)           results from the
research and development by the Receiving Party, its AFFILIATES or
SUBLICENSEES, independent of disclosures from the other party of this
AGREEMENT, provided that the persons developing such information have not had
exposure to the Information received from the disclosing party; or

 

(e)           CeNeS and LICENSEE
agree in writing may be disclosed.

 

10.4         Confidential Nature of
the Terms of Agreement. Except as expressly provided herein, CeNeS and LICENSEE
each agrees not to disclose any terms of this AGREEMENT to any third party
without the consent of the other party; provided, however, that disclosures may
be made as required by securities or other applicable laws, or to actual or
prospective investors, corporate partners or acquirers, or to a party’s
accountants, attorneys, and other professional advisors who agree to
appropriate confidentiality provisions to protect such terms from disclosure or
improper use.

 

15

 

ARTICLE XI

GENERAL

 

11.1         CeNeS Representations and
Warranties. CeNeS represents and warrants that;

 

(a)           (a) its obligations
under this AGREEMENT are not in conflict with any prior commitments or
obligations to any third party; that it has all requisite power and authority
to enter into this AGREEMENT; and that all corporate action necessary to
authorize its execution and delivery of this AGREEMENT has been duly taken;

 

(b)           it has the right to
grant the rights granted in this AGREEMENT and perform the obligations set
forth herein;

 

(c)           it and its Affiliates
have not granted to any third party any license, option or other rights under
the Patent Rights and to its knowledge, the Harvard License is in full force
and effect;

 

(d)           to its knowledge, there
are no facts or circumstance which would render any, of the Patent Rights
invalid or unenforceable; and

 

(e)           to its knowledge, there
is no interference action, opposition, reissue or reexamination proceeding, or
any intellectual property litigation pending before any patent office or court
concerning any of the Patent Rights.

 

11.2         CeNeS does not warrant
the validity of the PATENT RIGHTS licensed hereunder and makes no
representations whatsoever with regard to the scope of the licensed PATENT
RIGHTS or that such PATENT RIGHTS may be exploited by LICENSEE, an AFFILIATE or
SUBLICENSEE without infringing other patents.

 

11.3         Acorda Representations
and Warranties. Acorda represents and warrants that its obligations under this
AGREEMENT are not in conflict with any prior commitments or obligations to any
third party; that it has all requisite power and authority to enter into this
AGREEMENT; and that all corporate action necessary to authorize its execution
and delivery of this AGREEMENT has been duly taken.

 

11.4         CeNeS EXPRESSLY DISCLAIMS
ANY AND ALL IMPLIED OR EXPRESS WARRANTIES AND MAKES NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE
PATENT RIGHTS, INFORMATION SUPPLIED BY CeNeS OR LICENSED PRODUCTS CONTEMPLATED
BY THIS AGREEMENT.

 

11.5         Indemnification by
LICENSEE.

 

(a)           LICENSEE shall
indemnify, defend and hold harmless CeNeS, Harvard and STANFORD and their
current or former directors, governing board members, trustees, officers,
faculty, medical and professional staff, employees, students, and agents and
their respective successors, heirs and

 

16

 

assigns (collectively,
the “CeNeS Indemnitees”), against any liability, damage, loss or expenses
(including reasonable attorneys’ fees and expenses of litigation) incurred by
or imposed upon the CeNeS Indemnitees or any of them in connection with any
third party claims, suits, actions, demands or judgments arising out of any
theory of product liability (including, but not limited to, actions in the form
of tort, warranty, or strict liability) concerning any product, process or
service made, used or sold by LICENSEE, its AFFILIATES or SUBLICENSEES pursuant
to any right or license granted under this AGREEMENT.

 

(b)           CeNeS shall indemnify,
defend and hold harmless LICENSEE, its AFFILIATES, directors, officers, agents,
contractors, SUBLICENSEES and employees (collectively, the “LICENSEE
Indemnitees”); against any -liability, damage, loss or expenses (including
reasonable attorney’s fees and expenses of litigation) incurred by or imposed
upon the LICENSEE Indemnitees or any of them in connection with (1) any third
party claims, suits, actions, demands or judgments arising out of any breach of
Section 11.1 by CeNeS or (ii) LICENSEE’S actions pursuant to
Section 9.5.

 

(c)           LICENSEE shall, at its
own expense, provide attorneys reasonably acceptable to CeNeS, Harvard and
STANFORD to defend against any actions brought or filed against any Indemnitee
hereunder with respect to the subject of indemnity contained herein, whether or
not such actions are rightfully brought.

 

11.6         (a)           Beginning at the time any such product,
process or service is being commercially distributed or sold (other than for
the purpose of obtaining regulatory approvals) by LICENSEE, its AFFILIATE,
SUBLICENSEE or agent of LICENSEE, LICENSEE shall, at its sole cost and expense,
procure and maintain commercial general liability insurance in amounts not less
than $2,000,000 per incident and $2,000,000 annual aggregate and naming the
CeNeS Indemnitees as additional insureds. During clinical trials of any such
product, process or service, LICENSEE shall, at its sole cost and expense,
procure and maintain commercial general liability insurance in such equal or
lesser amount as CeNeS, Harvard or STANFORD shall require, naming the CeNeS
Indemnitees as additional insureds. Such commercial general liability insurance
shall provide: (i) product liability coverage; and (ii) broad form contractual
liability coverage for LICENSEE’s indemnification under this AGREEMENT. If
LICENSEE elects to self-insure all or part of the limits described above
(including deductibles or retentions which are in excess of $250,000 annual
aggregate) such self-insurance program must be acceptable to CeNeS, Harvard and
the Risk Management Foundation of the Harvard Medical Institutions, Inc. in
their sole discretion. The minimum amounts of insurance coverage required shall
not be construed to create a limit of LICENSEE’s liability with respect to its
indemnification under this AGREEMENT.

 

17

 

(b)           LICENSEE shall provide
CeNeS and Harvard with written evidence of such insurance upon request of CeNeS
or Harvard. LICENSEE shall provide CeNeS with written notice at least fifteen
(15) days prior to the cancellation, non-renewal or material change in such
insurance; if LICENSEE does not obtain replacement insurance providing
comparable coverage within such fifteen (15) day period, CeNeS and/or Harvard shall
have the right to terminate this AGREEMENT on written notice.

 

(c)           LICENSEE shall maintain
such commercial general liability insurance beyond the expiration or
termination of this AGREEMENT during: (i) the period that any product, process,
or service, relating to, or developed pursuant to, this AGREEMENT is being
commercially distributed or sold by LICENSEE, SUBLICENSEE, AFFILIATE or agent
of LICENSEE; and (ii) a reasonable period after the period referred to in
Subsection (c)(i) above which in no event shall be less than ten (10)
years.

 

11.7         Use of Name. LICENSEE
shall not use CeNeS’s, Harvard’s nor STANFORD’s name or insignia, nor any
adaptation thereof, nor the name of any of Harvard’s or STANFORD’s inventors,
in any advertising, promotional or sales literature without the prior written
approval of CeNeS, Harvard or STANFORD, respectively.

 

11.8         This AGREEMENT may not be
transferred without the prior written consent of CeNeS and Harvard in each
instance, which consent shall not be unreasonably withheld or delayed. The
preceding sentence notwithstanding, Licensee shall have the right to transfer
or assign this AGREEMENT and the rights granted hereunder in whole or in part
to any person or corporation succeeding to its business as a result of sale, consolidation,
reorganization, or otherwise, provided such assignee, person, or corporation
shall, without delay, accept in writing the provisions of this AGREEMENT and
agree to become in all material respects bound thereby in the place and stead
of LICENSEE.  This AGREEMENT shall be
binding upon the respective successors, legal representatives and assignees of
CeNeS, Harvard and of LICENSEE.

 

11.9         The interpretation and
application of the provisions of this AGREEMENT shall be governed by the laws
of the state of New York and the United-States of America.

 

11.10       LICENSEE shall comply with
all applicable laws and regulations in connection with the exercise of its
rights hereunder. In particular, it is understood and acknowledged that the
transfer of certain commodities and technical data is, subject to United States
laws and regulations controlling the export of such. commodities and technical
data, including all Export Administration Regulations of the United States
Department of Commerce. These laws and regulations among other things, prohibit
or require a license for the export of certain types of technical data to
certain specified countries. LICENSEE hereby agrees and gives written assurance
that it will comply with all United States laws and regulations

 

18

 

controlling the export of
commodities and technical data, that it will be solely responsible for any
violation of such by LICENSEE or its AFFILIATES or sublicensees, and that it
will defend and hold CeNeS, Harvard and STANFORD harmless in the event of any
legal action of any nature occasioned by such violation.

 

11.11       LICENSEE agrees: (i) to use
reasonable efforts to obtain all regulatory approvals required for the
manufacture and sale of LICENSED PRODUCTS; and (ii) to utilize appropriate
patent marking on such LICENSED PRODUCTS. LICENSEE also agrees to register or
record this AGREEMENT as is required by law or regulation in any country where
the license is in effect.

 

11.12       Any notices to be given
here under shall be sufficient if signed by the party (or, party’s
attorney)giving same and either: (i) delivered in person; (ii) mailed certified
mail, postage prepaid, return receipt requested; or (iii) faxed to other party
if the sender has evidence of successful transmission and if the sender
promptly sends the original by ordinary mail, in any event to the following
addresses:

 

If to Acorda:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, NY 10532

Attn: President and Chief Executive Officer

 

with a copy to:

 

Acorda Therapeutics, Inc.

15 Skyline Drive

Hawthorne, NY 10532

Attn. Harold Safferstein, Vice President, Business Development

 

If to CeNeS:

 

CeNeS Pharmaceuticals plc

Compass House

Vision Park

Chivers Way

Histon, Cambridge CB4 9ZR

England

Attn: Neil Clark, Chief Operating Officer and Finance Director

 

By such notice either
party may change their address for future notices. Notices delivered in person
shall be deemed given on the date delivered. Notices sent by fax shall be
deemed given on the date faxed. Notices mailed shall be deemed given on the
date postmarked on the envelope.

 

19

 

11.13       Should a court of competent
jurisdiction later hold any provision of this AGREEMENT to be invalid, illegal,
or unenforceable, and such holding is not reversed on appeal, it shall be
considered severed from this AGREEMENT. All other provisions, rights and
obligations shall continue without regard to the severed provision, provided
that the remaining provisions of this AGREEMENT are in accordance with the
intention of the parties.

 

11.14       This AGREEMENT constitutes
the entire understanding between the parties and supersedes all written and
prior agreements or understandings with regards to the subject matter hereof
except that any confidential information disclosed pursuant to the LICENSE
OPTION AGREEMENT shall be deemed Information of this AGREEMENT. Neither party
shall be obligated by any condition or representation other than those
expressly stated herein or as may be subsequently agreed to by the parties
hereto in writing.

 

11.15       LICENSEE’S relationship
with CeNeS shall be that of a licensee only. Neither party shall, be considered
to be an employee or agent of the other, nor shall this Agreement constitute,
create or in any way be interpreted as a joint venture, partnership or formal
business organization of any kind. In that respect, neither party shall have
the authority to execute any agreement on behalf of the other party, nor shall,
either party have any authority to negotiate any agreement, except as the other
party may expressly direct in writing.

 

11.16       This AGREEMENT maybe
executed in one or more counterparts, each of which shall be deemed an
original, but all of which shall constitute one and the same instrument:

 

IN WITNESS WHEREOF, the
parties hereto have caused this AGREEMENT to be executed by their duly
authorized representatives.

 

 

	
  CeNeS
  Pharmaceuticals PLC

  	
  Acordia
  Therapeutics, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Neil Clark

  	
   

  	
  By:

  	
  /s/ Harold T.
  Safferstein

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Print Name:

  	
  Neil Clark

  	
   

  	
  Print Name:

  	
  Harold T.
  Safferstein

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Finance Director

  	
   

  	
  Title:

  	
  VP Business
  Development

  	
   

  
										

 

20

 

APPENDIX
A

 

LAHIVE AND, COCKFIELD
CASES

 

•      US Patent Application serial number 08/525,864
filed September 8,1995 entitled “Cerebellum-Derived Growth Factors and
Uses Related Thereto”

 

•      PCT Patent Application serial number
PCT/US96/14484 filed September 9,1996 entitled “Cerebellum-Derived Growth
Factors, and Uses Related Thereto,”. designating Australia, Canada, EPO, Japan
and South Korea

 

•      U.S. Patent Number 5,912,326

Cerebellum-Derived Growth Factors

Inventor: Han Chang

Filed September 8, 1995

Issued June 15, 1999

 

•      European Patent Application Number 96 93 2981.2

Cerebellum-Derived Growth Factors. and Uses Related Thereto

Filed September 9,1996

 

•      Canadian Patent Application Number 2,228,590

Cerebellum-Derived Growth Factors and Uses Related Thereto

Filed September 9,1996

 

•      Australian Patent Application Number 71563/96 

Cerebellum-Derived Growth Factors and Uses Related Thereto 

Filed September 9, 1996

 

•      Japanese Patent Application Serial Number
9-511448

Cerebellum-Derived Growth Factors and Uses Related Thereto

Filed September 9, 1996

 

•      South Korean Patent Application Serial Number
701775/98

Cerebellum-Derived Growth Factors and Uses. Related Thereto

Filed September 9,1996

 

CLARK
& ELBING CASES

 

•      United States. Patent Application Serial Number
60/206,495

nrg-Z nucleic acid Molecules, polypeptides, and diagnostic and therapeutic
methods 

Filed 23-May-2000

 

•      United States Patent Application Serial Number
09/864,675

nrg-2 nucleic acid molecules, polypeptides, and diagnostic and therapeutic
methods

Filed May 23.2001.

 

•      PCT Patent Application Serial Number US01/16896

nrg-2 nucleic add molecules, polypeptides, and diagnostic and therapeutic
methods 

Filed May 23 2001.

 

21

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

 

APPENDIX
B

 

The following. comprise
BIOLOGICAL MATERIALS supplied by Stanford:

 

• cerebellum-derived growth factor (CDGF) cDNA
clones

- rat DCDGP cDNA 2b, 2d, 3

- human CDCF.cDNA clone
h-nrg-2

 

• expression construct and cell lines:

- pRc/CMV-2b; for, rat
CDGF-beta

- CHO cells stably
transfected with pRc/CMV2-b

 

 

22

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