Exhibit
10.20


 


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


 


LICENSE AGREEMENT


 


BETWEEN


 


ACORDA THERAPEUTICS, INC.


 


AND


 


THE MAYO FOUNDATION FOR

EDUCATION AND RESEARCH


 


Dated: 
September 8, 2000


 

















 


TABLE OF CONTENTS


 


	
  1.

  	
  DEFINITIONS.

  
	
   

  	
  1.1

  	
  “Affiliate”

  
	
   

  	
  1.2

  	
  “FDA”

  
	
   

  	
  1.3

  	
  “Field”

  
	
   

  	
  1.4

  	
  “First Commercial Sale”

  
	
   

  	
  1.5

  	
  “Key Claims”

  
	
   

  	
  1.6

  	
  “Know-How”

  
	
   

  	
  1.7

  	
  “Invention”

  
	
   

  	
  1.8

  	
  “Licensed Patents”

  
	
   

  	
  1.9

  	
  “Licensed Product”

  
	
   

  	
  1.10

  	
  “Licensed Technology”

  
	
   

  	
  1.11

  	
  “Marketing Exclusivity
  Rights”

  
	
   

  	
  1.12

  	
  “Material Breach”

  
	
   

  	
  1.13

  	
  “Net Sales”

  
	
   

  	
  1.14

  	
  “Patent Term Extensions”

  
	
   

  	
  1.15

  	
  “Patent Term
  Extensions Information”

  
	
   

  	
  1.16

  	
  “Party”

  
	
   

  	
  1.17

  	
  “PLA”

  
	
   

  	
  1.18

  	
  “Regulatory Review Period”

  
	
   

  	
  1.19

  	
  “Royalty Term”

  
	
   

  	
  1.20

  	
  “Sublicensee”

  
	
   

  	
  1.21

  	
  “Termination”

  
	
   

  	
  1.22

  	
  “Territory”

  
	
   

  	
  1.23

  	
  “Valid Claim”

  
	
   

  	
   

  	
   

  
	
  2.

  	
  GRANT OF
  LICENSE.

  
	
   

  	
  2.1

  	
  License Grant

  
	
   

  	
  2.2

  	
  Reserved Rights

  
	
   

  	
  2.3

  	
  Representations and Warranties.

  
	
   

  	
  2.4

  	
  Right of First Offer

  
	
   

  	
  2.5

  	
  Opportunity to
  Conduct Clinical Studies

  
	
   

  	
   

  	
   

  
	
  3.

  	
  PAYMENTS;
  ROYALTIES.

  
	
   

  	
  3.1

  	
  Upfront Consideration Royalty.

  
	
   

  	
  3.2

  	
  Milestone
  Royalties for Licensed Products

  
	
   

  	
  3.3

  	
  Running
  Royalties for Sales of Licensed Products.

  
	
   

  	
  3.4

  	
  Third Party Royalties

  
	
   

  	
  3.5

  	
  Certain
  Affiliate and Sublicensee Royalties

  
	
   

  	
  3.6

  	
  Obligation to Pay Royalties

  
	
   

  	
  3.7

  	
  Royalties on Combined
  Products

  



 


i

















 


	
  4.

  	
  PAYMENTS
  AND RECORDS.

  
	
   

  	
  4.1

  	
  Payment

  
	
   

  	
  4.2

  	
  Mode of Payment

  
	
   

  	
  4.3

  	
  Taxes

  
	
   

  	
  4.4

  	
  Records Retention

  
	
   

  	
  4.5

  	
  Audit Request

  
	
   

  	
   

  	
   

  
	
  5.

  	
  DUE DILIGENCE.

  
	
   

  	
  5.1

  	
  Diligence

  
	
   

  	
  5.2

  	
  Reports

  
	
   

  	
  5.3

  	
  Short-Form Arbitration

  
	
   

  	
   

  	
   

  
	
  6.

  	
  “OWNERSHIP;
  PATENTS; MARKETING EXCLUSIVITY; PATENT TERM EXTENSIONS”

  
	
   

  	
  6.1

  	
  Ownership.

  
	
   

  	
  6.2

  	
  Patent Prosecution
  and Maintenance.

  
	
   

  	
  6.3

  	
  Patent Enforcement.

  
	
   

  	
  6.4

  	
  Infringement
  Action by Third Parties.

  
	
   

  	
  6.5

  	
  Marketing
  Exclusivity/Patent Term Extensions

  
	
   

  	
   

  	
   

  
	
  7.

  	
  PUBLICATION;
  CONFIDENTIALITY.

  
	
   

  	
  7.1

  	
  Publication

  
	
   

  	
  7.2

  	
  Confidentiality;
  Exceptions.

  
	
   

  	
  7.3

  	
  Exceptions to Obligation

  
	
   

  	
  7.4

  	
  Confidentiality
  regarding Patient Information

  
	
   

  	
   

  	
   

  
	
  8.

  	
  INDEMNIFICATION.

  
	
   

  	
  8.1

  	
  Products Liability

  
	
   

  	
  8.2

  	
  MAYO Indemnification.

  
	
   

  	
  8.4

  	
  Notice; Waiver of
  Subrogation.

  
	
   

  	
   

  	
   

  
	
  9.

  	
  TERM
  AND TERMINATION.

  
	
   

  	
  9.1

  	
  Term

  
	
   

  	
  9.2

  	
  Breach

  
	
   

  	
  9.3

  	
  Insolvency or Bankruptcy

  
	
   

  	
  9.4

  	
  Termination by ACORDA

  
	
   

  	
  9.5

  	
  Right to Sell Stock on Hand

  
	
   

  	
  9.6

  	
  Effect of Termination.

  
	
   

  	
  9.7

  	
  Accrued and
  Surviving Rights and Obligations

  
	
   

  	
   

  	
   

  
	
  10.

  	
  MISCELLANEOUS PROVISIONS.

  
	
   

  	
  10.1

  	
  Relationship of Parties

  
	
   

  	
  10.2

  	
  Assignment

  
	
   

  	
  10.3

  	
  Further Actions

  



 


ii

















 


	
   

  	
  10.4

  	
  Force Majeure

  
	
   

  	
  10.5

  	
  No Trademark Rights

  
	
   

  	
  10.6

  	
  Public Announcements

  
	
   

  	
  10.7

  	
  Notices

  
	
   

  	
  10.8

  	
  Amendment

  
	
   

  	
  10.9

  	
  Waiver

  
	
   

  	
  10.10

  	
  Severability

  
	
   

  	
  10.11

  	
  Compliance with Law

  
	
   

  	
  10.12

  	
  Governing Law and
  Jurisdiction

  
	
   

  	
  10.13

  	
  Entire Agreement of the
  Parties

  
	
   

  	
  10.14

  	
  Descriptive Headings

  
	
   

  	
  10.15

  	
  Nondisclosure

  
	
   

  	
  10.16

  	
  Counterparts

  



 


iii

















 


LIST
OF EXHIBITS


 


	
   

  	
  EXHIBIT A

  
	
   

  	
   

  
	
   

  	
  EXHIBIT B

  
	
   

  	
   

  
	
   

  	
  EXHIBIT C

  
	
   

  	
   

  
	
   

  	
  EXHIBIT D

  
	
   

  	
   

  
	
   

  	
  EXHIBIT E

  



 


iv

















 


LICENSE AGREEMENT


 


THIS LICENSE AGREEMENT (this “Agreement”) is entered
into as of September 8, 2000 (the “Effective Date”), by and between Acorda
Therapeutics, Inc., a Delaware corporation, having offices at 15 Skyline Drive,
Hawthorne, New York 10532, (“ACORDA”) and The Mayo Foundation for Medical
Education and Research, a Minnesota charitable corporation located at 200 First
Street SW, Rochester, Minnesota 55905 (“MAYO”).


 


PRELIMINARY STATEMENTS


 


A.                                   ACORDA
has sponsored two research programs under the direction of Dr.  Moses Rodriguez and Dr.  Larry Pease, entitled (1) Preclinical
Studies of a Monoclonal Antibody Designed to Promote Central Nervous Repair,
and (2) Molecular Characterization of Antibody-Induced Remyelination and
Isolation of Human Counterparts, (each a “Program” and collectively, the
“Programs”), pursuant to two Sponsored Research Agreements between MAYO and
ACORDA, dated as of October 1, 1995 and March 15, 1998, respectively,
(the “Sponsored Research Agreements”) which are attached hereto as Exhibit A.  These Programs have related to, among other
things, the therapeutic use of humanized and non-humanized antibodies for
treatment of central nervous system conditions and disorders, including
myelination or remyelination in conditions such as spinal cord injuries and
multiple sclerosis.


 


B.                                     MAYO
is the owner of certain right, title and interest to technology made or
otherwise developed in performance of the Programs including certain
inventions, discoveries and patents described in the Sponsored Research
Agreements.


 


C.                                     MAYO
has the right to grant licenses to this technology so that such technology may
be utilized in the public interest, and is willing to grant a license
thereunder to ACORDA.


 


D.                                    ACORDA
has options, pursuant to ACORDA\MAYO Option Agreements dated as of
October 1, 1995 and March 15, 1998 (the “Option Agreements”), which
are attached hereto as Exhibit B, to acquire an exclusive, worldwide
license to such technology and is desirous of obtaining certain rights and
licenses from MAYO relating to the aforementioned technology.


 


E.                                      ACORDA
wishes to exercise the options under both Option Agreements and ACORDA and MAYO
now desire to provide for the license of all technology in all fields
contemplated by the exercise of the options granted under both of the Option
Agreements under one unified set of terms conditions, and for revised
consideration, as provided under this Agreement, which shall be deemed to amend
and supercede the provisions of the Option Agreements.


 


NOW THEREFORE, in consideration of the foregoing and
of the mutual covenants contained in this Agreement, the Parties hereto agree
to the provisions of the Preliminary Statements and as follows:


 

















 


1.                                      DEFINITIONS.


 


As used in this
Agreement, the following terms will have the meanings set forth in this
Section 1 unless the context dictates otherwise.


 


1.1                                 “Affiliate” shall mean, with respect to either
person, any corporation or other business entity which controls, is controlled
by or is under common control with such person.  For this purpose, control means the possession of the power to
direct or cause the direction of the management and the policies of an entity
whether through ownership directly or indirectly of fifty percent (50%) or more
of the stock entitled to vote, and for non-stock organizations, the right to
receive over fifty percent (50%) of the profits by contract or otherwise, or if
not meeting the preceding requirement, any company owned or controlled by or
owning or controlling such person at the maximum control or ownership right
permitted in the country where such entity exists.


 


1.2                                 “FDA” shall mean the U.S. 
Food and Drug Administration, or the successor thereto.


 


1.3                                 “Field” shall mean the prevention, mitigation or
treatment of nervous system disorders, diseases or injuries including, without
limitation, pain, and any and all other diagnostic, therapeutic,
pharmaceutical, cosmetic, medical or health care related applications.


 


1.4                                 “First Commercial Sale” shall mean, with
respect to any Licensed Product, the first sale for use or consumption by the
general public of such Licensed Product in any country in the Territory after
all required marketing approvals have been granted, or, if such sale is
otherwise permitted, by the governing health regulatory authority of such
country.


 


1.5                                 “Key Claims” shall have the meaning assigned to such
term in Section 3.2(a).


 


1.6                                 “Know-How” shall mean any and all technical data,
information, inventions, biological materials, trade secrets, and other
intellectual property, whether patentable or unpatentable, conceived or
otherwise developed in the course of and in connection with the Programs, and
all subsequent modifications, enhancements and improvements hereto, excluding
the patent applications and patents within the Licensed Patents.


 


1.7                                 “Invention” shall mean any new and useful invention,
discovery„ process, improvement or other intellectual property conceived of,
first reduced to practice, made or otherwise developed by MAYO, its employees
or agents including Dr.  Moses Rodriguez
and Dr.  Larry Pease, in connection with
and during the term of either of the Programs and this Agreement, and during the
two year period thereafter.


 


1.8                                 “Licensed Patents” shall mean, collectively:


 


(a)                                  United
States Patent No.  5,591,629, (formerly
Application S.N.  08/236,520, filed
April 29, 1994), entitled “Monoclonal Antibodies Which Promote Central
Nervous System Remyelination,” the inventions described and claimed therein,
and any substitutions, extensions, renewals, divisions, patents-of-addition,
continuations, continuations-in-part to the extent the claims are directed to
subject matter specifically described in such patent


 


2

















 


(including, but not
limited to, all of those continuations-in-part specifically listed on Exhibit
C), patents issuing thereon or reissues, extensions or supplementary protection
certificates thereof, and any and all patents and patent applications
throughout the Territory corresponding thereto; and


 


(b)                                 All
patents and patent applications, and any substitutions, extensions, renewals,
divisions, patents-of-addition, continuations, continuations-in-part to the
extent the claims are directed to subject matter specifically described in such
patent or patent application, patents issuing thereon or reissues,
re-examinations, extensions or supplementary protection certificates thereof,
and any and all foreign counterparts thereto concerning any invention,
technology or other intellectual property owned in whole or in part by MAYO and
made, first reduced to practice or otherwise developed in connection with the
Programs, whether before or after the date of this Agreement, or derivatives or
analogs thereof, including any and all technology which may be subject to
either of the Option Agreements.


 


1.9                                 “Licensed Product” shall mean any product or
part thereof which is covered, in whole or in part, by a Valid Claim of a
Licensed Patent in the country in which such product is made, used or sold, or
which incorporates or utilizes Know-How.


 


1.10                           “Licensed Technology” shall mean the
Licensed Patents and the Know-How, collectively.


 


1.11                           “Marketing Exclusivity Rights”
shall mean any rights to which a Licensed Product may be eligible in addition
to or in lieu of rights under the Licensed Patents including rights to
exclusivity provided in 21 USC §505, 21 USC §360aa-ee, the Orphan Drug Act, the
marketing exclusivity provisions of Article 8(a) of Directive 65/65/EEC
Relating to Medicinal Products and any other legislation on regulations as
amended from time to time in the Territory applicable to this Agreement
providing for non-patent marketing exclusivity for any Licensed Product whether
such legislation or regulation is operative on the Effective Date of this
Agreement or becomes operative thereafter;


 


1.12                           “Material Breach” shall mean a breach of this
Agreement which is specified in this Agreement as being a material breach, and
in addition, any breach of this Agreement which is so injurious to the
relationship between the Parties that this Agreement should reasonably be
subject to immediate Termination by the non-breaching Party.


 


1.13                           “Net Sales” shall mean, with respect to any Licensed
Product, the gross amount invoiced for such Product by ACORDA, its Affiliates
and Sublicensees, to third parties, less deductions for: (i) trade, quantity
and/or cash discounts, allowances and rebates (including, without limitation,
promotional allowances or discounts or similar allowances) actually allowed or
given; (ii) freight, postage, shipping, insurance and transportation expenses
and similar charges (in each instance, if separately identified in such
invoice); (iii) credits or refunds actually allowed for rejections, defects or
recalls of such Licensed Product, outdated or returned Licensed Product, or
because of rebates or retroactive price reductions; and (iv) sales, value-added
and excise taxes, tariffs and duties, and other taxes directly related to the
sale, to the extent that such items are included in the gross invoice price
(but not including taxes assessed against the income derived from such
sale).  Such amounts shall be determined
from the books and records of


 


3

















 


ACORDA, its Affiliates or
its Sublicensees, maintained in accordance with the reasonable accounting
principles used by such entity, consistently applied.


 


1.14                           “Patent Term Extensions” shall mean the
interim or permanent extension ofthe term of any Licensed Patents or claims
covered by any Licensed Patents for any Licensed Product for which MAYO may be
eligible under 35 U.S.C.  § 156 or any
otherU.S.  or non-U.S.  statute providing for extensions of patent
terms;


 


1.15                           “Patent Term Extensions Information”
shall mean information within a non-filing Party’s possession or control which
may be requested by the Party responsible for filing and prosecuting an
application or petition for a Patent Term Extension, such information as may be
requested by the Patent and Trademark Office and execution of all necessary
documentation in connection therewith for the filing Party to make a timely and
complete filing and prosecution of an application for a Patent Term Extension;


 


1.16                           “Party” shall mean ACORDA or MAYO and, when used in the
plural, shall mean ACORDA and MAYO.


 


1.17                           “PLA” shall mean a product license application, or with
respect to any product license application already filed as of the Effective
Date a supplemental product license application thereto, filed with the United
States FDA, or the equivalent regulatory filing required to be filed with the
regulatory authorities in any other jurisdiction outside the United States.


 


1.18                           “Regulatory Review Period” shall mean
the period of time defined in 35 U.S.C. 
§ 156(g) and applicable to any Licensed Product;


 


1.19                           “Royalty Term” shall mean, with respect to each
Product in each country in the Territory, the period commencing on the date of
the First Commercial Sale of such Product and expiring on the earlier of: (a)
the later of (i) the expiration of the last Key Claim covering such Product in
such country, or (ii) the expiration of any exclusive approval period granted
with respect to such Product under the Orphan Drug Act, 21 U.S.C.  § 360aa et.  seq., as amended from time to
time, or (iii) ten years from the First Commercial Sale, or (iv) fifteen years
from the Effective Date; or (b) the Termination of this Agreement.


 


1.20                           “Sublicensee” shall mean any non-Affiliate third
party sublicensed by ACORDA to make, have made, import, use or sell any
Licensed Product.


 


1.21                           “Termination” of this Agreement shall mean the
ending, expiration, rescission, or any other discontinuation of this contract
for any reason whatsoever.


 


1.22                           “Territory” shall mean the entire world.


 


1.23                           “Valid Claim” shall mean either: (i) a claim of an
issued and unexpired patent included in the Licensed Patents, which has not
been held permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal, and which claim
has not been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise, or (ii) a pending claim of a pending patent
application that is classified under Section 1.7 as


 


4

















 


Licensed Patents, which
claim (a) was filed in good faith, (b) is reasonably likely to issue, (c) has
not been abandoned or finally disallowed without the possibility of appeal or
refining of said application, and (d) has not been pending for a period in
excess of seven (7) years from the earliest date from which the patent
application was filed or claims priority in such country.


 


2.                                      GRANT OF LICENSE.


 


2.1                                 License Grant. 
Subject to the terms and conditions of this Agreement, MAYO hereby
grants to ACORDA, subject to any rights of the U.  S.  Government under 35
U.S.C.  § 200 etseq.  and all
regulations promulgated pursuant thereto, the exclusive (even as to MAYO),
worldwide right and license under the Licensed Technology to develop, make,
have made, use, import, export, lease, offer to sell, sell, have sold and
otherwise exploit Licensed Products for use in the Field in the Territory, and
to grant, offer for sale and authorize sublicenses with respect to the right
and license granted under this Section 2.1 to other third parties.


 


2.2                                 Reserved Rights.  Notwithstanding the right and license granted in
Section 2.1, MAYO reserves the right to use the Licensed Technology solely
for purposes of education, internal research and verification of adherence to
MAYO’s policies regarding the responsible conduct of research, and for MAYO’s•patient
care, at the discretion of MAYO’s physicians, conducted within MAYO’s
facilities located in Rochester, Minnesota, Scottsdale, Arizona and
Jacksonville, Florida.  MAYO may also
share aliquots of antibody related to Licensed Technology with other academic
institutions solely for non-commercial research purposes as ACORDA may approve
in advance, provided that no antibody shall be shared which is not already
subject to an issued U.S.  Patent or
pending U.S.  patent application, and
provided further, that any such other academic institution must sign a material
transfer agreement in form acceptable to ACORDA, whereby such institution
confirms (a) that the antibody provided is the subject of an issued or pending
Patent, (b) the proprietary rights of ACORDA under this Agreement, and (c) that
all rights to all commercial applications resulting from such institution’s
research making use of such transferred material shall belong exclusively to
MAYO and be considered part of the license granted to ACORDA under this
Agreement.  The Parties agree that the
form of material transfer agreement attached to this Agreement as Exhibit E may
be used for such purpose, provided that MAYO must still obtain ACORDA’s prior
approval for any specific agreement and transfer in each instance.  Nothing in this Section 2.2 shall
permit MAYO to use the Licensed Technology to develop any product for
commercial use, or give any third party such right.


 


2.3                                 Representations and Warranties.


 


(a)                                  MAYO
hereby represents and warrants that:


 


(i)                                     It
has the right to grant the right and license granted to ACORDA under this
Section 2 and that (except as may be provided in that certain agreement
dated January 9, 1997 between MAYO and TEVA Pharmaceutical Industries,
Ltd.  (the “TEVA Agreement”) which
purports to grant certain rights to TEVA with respect to certain research
results which may or may not be considered part of the Licensed Technology
licensed hereunder and is the subject of the special indemnification provided
under Section 8.2 (b) of this Agreement) MAYO


 


5

















 


has not
entered into any agreement with any third party which is in conflict with the
rights granted to ACORDA pursuant to this Agreement; and


 


(ii)                                  It
has fully disclosed to ACORDA all information in MAYO’s possession or control
relating to the Licensed Technology, including, without limitation, any
communications with any third parties relating to any of the foregoing.


 


(b)                                 NO OTHER WARRANTIES.


 


(i)                                     Except
as expressly provided in this Agreement, nothing in this Agreement shall be
construed as a warranty or representation by MAYO as to: the validity or scope
of any patents contained in the Licensed Technology; an obligation to bring or
to prosecute actions against third parties for infringement of patent; or
conferring by implication, estoppel, or otherwise any patents of MAYO.


 


(ii)                                  MAYO
HAS NOT MADE AND PRESENTLY MAKES NO PROMISES, GUARANTEES, REPRESENTATIONS OR
WARRANTIES OF ANY NATURE, DIRECTLY OR INDIRECTLY, EXPRESS OR IMPLIED, REGARDING
THE MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SUITABILITY, DURABILITY,
CONDITION, QUALITY, OR ANY OTHER CHARACTERISTIC OF THE LICENSED
TECHNOLOGY.  THE COMPANY TAKES THE
LICENSED TECHNOLOGY “AS IS,” “WITH ALL FAULTS,” AND “WITH ALL DEFECTS,” AND
EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST MAYO FOR
MISREPRESENTATION OR FOR BREACH OF PROMISE, GUARANTEE, OR WARRANTY OF ANY KIND
RELATING TO THE LICENSED TECHNOLOGY.


 


2.4                                 Right of First Offer.  The Parties recognize that MAYO may continue
to conduct internal research using the Licensed Technology, as it determines in
its discretion.  In the event that MAYO
develops any other application related to the Licensed Technology but outside
the scope of the license granted under this Agreement (a “New Product”), MAYO
hereby grants to ACORDA a right of first offer with respect to rights for any
such New Product in the Field, as follows:


 


(a)                                  In
the event that, at any time during the term of this Agreement, MAYO intends to
offer to a third party any rights to any New Product or receives an offer from
a third party to acquire any rights to any New Product, MAYO shall first offer
such rights to ACORDA, in writing, on terms no less favorable to ACORDA than
those to be offered to, or offered by, such third party


 


(b)                                 Within
30 days after receipt of any such offer, ACORDA shall notify MAYO in writing as
to whether it wishes to obtain such rights on such terms.  If ACORDA provides timely notice that ACORDA
wishes to obtain such rights, then the Parties shall conduct exclusive
negotiations in good faith and conclude an agreement incorporating such terms
within 120 days thereafter.


 


(c)                                  In
the event that (i) ACORDA gives MAYO notice that ACORDA does not wish to obtain
such rights, or (ii) ACORDA does not respond to MAYO’s notice within 30 days
after receipt thereof, then MAYO shall have the unrestricted right to enter
into an agreement with a third party for such rights.


 


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.


 


(d)                                 In
the event that the parties enter into negotiations pursuant to
Section 2.4(b), but are unable to agree upon the terms of such rights,
despite the use of good faith efforts, during the 120-day period set forth in
Section 2.4(b), then MAYO shall have the right, for a period of six months
thereafter, to enter into an agreement with a third party for such rights on
terms no more favorable to such third party than those last offered to ACORDA
pursuant to this Section 2.4.  In
the event that MAYO wishes to enter into such an agreement on terms more
favorable to such third party, MAYO shall reoffer such terms to ACORDA in
accordance with this Section 2.4. 
MAYO’s obligation to reoffer to ACORDA any particular New Product it has
not licensed to a third party during the six month period contemplated in the
first sentence of this Section 2.4(d) shall continue for the term of this
Agreement, and if MAYO continues its internal research related to such New
Product, it will disclose to ACORDA any material new information, technology,
or data developed by MAYO related to the New Product to permit ACORDA to
evaluate MAYO’s reoffer.


 


2.5                                 Opportunity to Conduct Clinical
Studies.  In the event that
ACORDA determines that it is desirable to conduct clinical studies in
connection with development of Licensed Products using the Licensed Technology,
ACORDA shall provide MAYO with the opportunity to be included as a study site
for such clinical studies, provided that MAYO has the necessary expertise, and
can perform such clinical study in a timely and cost efficient manner when
compared to the use of a third party. 
MAYO acknowledges that MAYO may not serve as a major clinical trial
site, when MAYO has a conflict of interest, whether actual or perceived, such
as in a registrational study.


 


3.                                      PAYMENTS; ROYALTIES.


 


3.1                                 Upfront Consideration Royalty.


 


(a)                                  In
partial consideration of the right and license granted to ACORDA hereunder,
ACORDA shall pay MAYO a fee of [**], due within thirty (30) days after the
Effective Date.  Such fee shall be
non-refundable, and non-creditable against any other royalty or fee payable
under this Agreement.


 


(b)                                 In
further consideration of the right and license granted to ACORDA hereunder,
ACORDA acknowledges that this Agreement permits MAYO to exercise the warrants
previously granted to MAYO in connection with the Option Agreement to purchase
60,000 shares of ACORDA common stock at the price of founders stock.  In the event MAYO elects to exercise such
warrants, ACORDA shall reimburse to MAYO the price paid by MAYO in order to
exercise such warrants.


 


3.2                                 Milestone Royalties for Licensed
Products.  In further
consideration of the right and license granted to ACORDA hereunder, ACORDA
shall pay to MAYO the following milestone payments upon the first occurrence of
each event set forth below:


 


(a)                                  In
as much as United States Patent No. 
5,591,629, as described in Section 1.8(a) has issued and contains
one or more of the key claims as contemplated by a prior Option Agreement among
the Parties (“Key Claims”), [**], within 30 days following the Effective Date.


 


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.


 


(b)                                 [**]
within thirty days following the issuance of the first U.S.  composition of matter Licensed Patent for a
human antibody.


 


(c)                                  [**]
within 30 days after the initiation of the first U.S.  Phase II clinical trial for the first Licensed Product chosen for
development (“First Licensed Product”) by ACORDA or its Affiliates or
Sublicensees.


 


(d)                                 [**]
upon the approval to market for therapeutic use given by the FDA to ACORDA or
its Affiliates or Sublicensees (“FDA Approval”) of the First Licensed Product,
which amount shall be paid in four equal installments, the first of which shall
be paid within 30 days following the date of such FDA Approval and the balance
of which shall be paid within 30 days after the end of the three-, six- and
nine-month periods following such date.


 


(e)                                  [**]
within 30 days after the earlier of (1) initiation of the second U.S.  Phase III clinical trial for the second
Licensed Product chosen for development, if any, (“Second Licensed Product”) by
ACORDA or its Affiliates or Sublicensees or (2) submission of a New Drug
Application (“NDA”) by ACORDA or its Affiliates or Sublicensees to the FDA for
such Second Licensed Product.


 


(f)                                    [**]
upon FDA Approval of the Second Licensed Product, which amount shall be paid in
four equal installments, the first of which shall be paid within 30 days
following the date of such FDA Approval and the balance of which shall be paid
within 30 days after the end of the three-, six- and nine-month periods
following such date.


 


(g)                                 [**]
within 30 days after the earlier of (1) initiation of the second U.S.  Phase III clinical trial for the third
Licensed Product chosen for development, if any, (“Third Licensed Product”) by
ACORDA or its Affiliates or Sublicensees or (2) submission of an NDA by ACORDA
or its Affiliates or Sublicensees to the FDA for such Third Licensed Product.


 


(h)                                 [**]
upon FDA Approval of the Third Licensed Product, which amount shall be paid in
four equal installments, the first of which shall be paid within 30 days
following the date of such FDA Approval and the balance of which shall be paid
within 30 days after the end of the three-, six- and nine-month periods
following such date.


 


3.3                                 Running Royalties for Sales of
Licensed Products.


 


(a)                                  In
further consideration of the right and license granted to ACORDA hereunder,
ACORDA shall pay to MAYO, in connection with the sale of Licensed Products by
ACORDA or its Affiliates or Sublicensees, in accordance with the following
schedule and rates:


 


(i)                                     With
respect to the First Licensed Product, provided that such First Licensed Product
is covered by a Valid Claim which contains a valid composition of matter claim
in the country where it is sold the applicable royalty rates shall be


 


[**] of the first [**] of
annual Net Sales; and


 


[**] of all annual Net
Sales in excess of [**].


 


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.


 


(ii)                                  With
respect to the Second Licensed Product, the Third Licensed Product, and each
subsequent Licensed Product, provided that each such Licensed Product is
covered by a Valid Claim which contains a valid composition of matter claim in
the country where it is sold, and taking each Licensed Product into account
separately and not aggregating Net Sales of separate Licensed Products, the
applicable royalty rates shall be:


 


[**] of the first [**] of
annual Net Sales;


 


[**] of annual Net Sales
between [**] and [**];


 


[**] of annual Net Sales
between [**] and [**]; and


 


[**] of annual Net Sales
in excess of [**].


 


(iii)                               With
respect to any Licensed Product which is not covered by a Valid Claim which
contains a composition of matter claim in the country where it is sold, but is
covered by a pending patent within the Licensed Patents containing a valid
composition of matter claim in the country where such Licensed Product is sold,
the applicable royalty rate shall be, in lieu of the foregoing rates, [**] on
all annual Net Sales


 


(b)                                 In
the event that any of the issued patents contemplated in Section 3.3(a)
contain only awarded valid utility claims, the Parties shall negotiate in good
faith lesser royalty rates for the sale of Licensed Products.  Such royalty rates shall reflect customary
royalties for intellectual property of the type, degree of proprietary
protection and value mutually agreed to by MAYO and ACORDA.


 


(c)                                  Beginning
on the first anniversary of the first commercial sale of the First Licensed
Product, ACORDA shall pay MAYO the following minimum annual royalties equal to
the difference between the actual annual amounts paid to MAYO pursuant to
Section 3.3(a) and (b) and the following:


 


(i)                                     [**]
on the first anniversary;


 


(ii)                                  [**]
on the second anniversary;


 


(iii)                               [**]
on the third anniversary; and


 


(iv)                              [**]
on the fourth anniversary and on each anniversary thereafter.


 


3.4                                 Third Party Royalties.  In the event that ACORDA, its Affiliates or
Sublicensees, as the case may be, pays royalties or other amounts to any third
party to make, use or sell a Licensed Product or to avoid or settle a claim of
infringement of the intellectual property rights of such third party, ACORDA
may offset such amounts paid against up to [**] of the amount of royalties due
from ACORDA to MAYO, provided however, that
in no event shall MAYO receive less that [**] of the Net Sales of the Licensed
Product sold by ACORDA, its Affiliates or Sublicensees, as the case may be.


 


9

















 


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


 


3.5                                 Certain Affiliate and Sublicensee
Royalties.  In the event
that ACORDA receives any royalties from Affiliates or Sublicensees with respect
to the sale of Licensed Products for use in applications that ACORDA has
decided, in its business judgment, not to commercialize, ACORDA shall pay MAYO
[**] of such amounts received, provided
however, that MAYO shall not be entitled to any share of amounts
received by ACORDA from its Affiliates or Sublicensees for:


 


(a)                                  equity;


 


(b)                                 debt;


 


(c)                                  research
and development;


 


(d)                                 any
payments attributable to performance based milestones;


 


(e)                                  the
license or sublicense of,


 


(i)                                     any
intellectual property other than the Licensed Patents,


 


(ii)                                  any
products other than the Licensed Products; or


 


(f)                                    reimbursement
for patent or other expenses.


 


3.6                                 Obligation to Pay Royalties.  In no event shall more than one.  royalty be due hereunder with respect to any
unit of Licensed Product even if covered by more than one patent or Valid Claim
of any patent included in the Licensed Patents.  Except as provided in Section 3.5, there shall be no
obligation to pay royalties to MAYO under this Section 3 on sales of
Licensed Products between ACORDA and its Affiliates and Sublicensees, but in
such instances the obligation to pay royalties shall arise upon the sale by
ACORDA or its Affiliates or Sublicensees. 
Failure to make such royalty payments shall be deemed a Material Breach
of this Agreement.  Payments due under
this Section 3 shall be deemed to accrue when payment is received by
ACORDA for Licensed Products.


 


3.7                                 Royalties on Combined Products.  Where a Licensed Product is sold in
combination with one or more other products that are not Licensed Products (the
“Combined Product”), ACORDA shall pay royalties to MAYO based upon the value of
the Combined Product attributable to the Licensed Patents.  The Parties agree to negotiate in good faith
to reach a mutual agreement concerning the value of Combined Product
attributable to such Licensed Patents, provided
however, that ACORDA shall pay MAYO no less than [**] of the Net
Sales of such Combined Product.


 


4.                                      PAYMENTS AND RECORDS.


 


4.1                                 Payment. 
Except as otherwise provided herein, all royalties and other.payments
due hereunder shall be paid quarterly within 45 days after the end of each
calendar quarter in which such payments or royalties accrue.  Each such payment shall be accompanied by a
statement identifying the payments made, including a Licensed
Product-by-Licensed Product and


 


10

















 


country-by-country statement of the amount of Net
Sales during such quarter, the amount of royalties due on such Net Sales and
the amount of any credits being applied to such royalties.  Failure to make such payments on time shall
be deemed a Material Breach of this Agreement.


 


4.2                                 Mode of Payment.  ACORDA shall make all payments required under this Agreement in
U.S.  Dollars.  The payments due shall be translated at the rate of exchange at
which United States Dollars for the currency of the country in which the
payment accrued, as listed in The Wall Street
Journal on the last business day of the calendar quarter in which
such sales, if any, were made.


 


4.3                                 Taxes.  Royalties
shall be paid to MAYO free and clear of all foreign taxes, including
withholding and turnover taxes, except such taxes which ACORDA may be required
to withhold by a foreign country.  Any
tax required to be withheld by ACORDA or its Affiliates or Sublicensees under
the laws of any foreign country for the account of MAYO shall be promptly paid
by ACORDA or its Affiliate or Sublicensee for and on behalf of MAYO, with proof
of payment of such tax together with official or other appropriate evidence
issued by the appropriate governmental authority sufficient to enable MAYO to
support a claim for income tax credit in’ respect to any sum so withheld.  Any such tax required to be withheld shall
be an expense of and borne solely by MAYO.


 


4.4                                 Records Retention.  ACORDA shall keep complete and accurate records pertaining to the
manufacture, use and sale of Licensed Products and in sufficient detail to
permit MAYO to confirm the accuracy of royalty calculations under this
Agreement.


 


4.5                                 Audit Request. 
At the request and expense of MAYO, ACORDA shall permit an independent,
certified public accountant appointed by MAYO and acceptable to ACORDA, at reasonable
times and upon reasonable notice, to examine those records as may be necessary
to: (i) determine, with respect to any calendar year ending not more than three
years prior to MAYO’s request, the correctness of any report or payment made
under this Agreement; or (ii) obtain information as to the royalty payable for
any calendar year in the case of ACORDA’S failure to report or pay pursuant to
this Agreement.  Results of any such
examination shall be made available to both Parties.  MAYO shall bear the full cost of the performance of any such
audit; provided however, that in
the event such audit reveals an underpayment by ACORDA in excess of five
percent of the total amount of payment due by ACORDA to MAYO for any calendar
year subject to such audit, ACORDA shall reimburse MAYO for the cost of such
audit.


 


5.                                      DUE DILIGENCE.


 


5.1                                 Diligence. 
ACORDA, directly or through its Affiliates or Sublicensees, shall use
reasonable commercial efforts, consistent with its business judgment, to
develop and commercialize Licensed Products during the term of this Agreement
and obtain and maintain such approvals as may be necessary for the sale of
Licensed Products in the United States and in such other worldwide markets as
ACORDA selects to commercialize such Licensed Products.


 


5.2                                 Reports. 
During the term of this Agreement and until the First Commercial Sale of
the first Licensed Product, ACORDA shall deliver to MAYO semi-annual reports,
due within


 


11

















 


45 days after the end of each June and December,
summarizing the efforts of ACORDA, its Affiliates and its Sublicensees to
develop and commercialize Licensed Products.


 


(a)                                  If
MAYO reasonably believes that ACORDA is not satisfying ACORDA’s diligence
obligations set forth in Section 5.1 (or does not have sufficient
information to make such determination), it may request ACORDA to inform MAYO
of such efforts as ACORDA, its Affiliates or Sublicensees are undertaking to
comply with its obligations thereunder. 
Within 60 days from receipt of such request, ACORDA shall then report
its efforts to develop and commercialize Licensed Products and, if either Party
requests, the Parties shall meet to discuss the situation.


 


(b)                                 At
any time during such 60-day period, either Party may request the use of a
mediator to assist in the resolution of such dispute.  In such event, both Parties shall try in good faith to resolve
such dispute by mediation administered by the American Arbitration Association
under its Commercial Mediation Rules by a single mediator, who shall have
experience and be knowledgeable in the pharmaceutical industry, appointed in
accordance with such rules.  The Parties
agree to submit to one day of mediation to take place within 30 days after the
selection of such mediator, unless the Parties otherwise agree.  The costs of any such mediation, including
administrative fees and fees of the mediator, shall be shared equally by the
Parties, and each Party shall bear its own expenses in such mediation.


 


(c)                                  If,
at the end of the later of the 60 day period referred to in Section 5.3(a)
or the unsuccessful conclusion of the mediation, if any, commenced pursuant to
Section 5.3(b), MAYO still believes that ACORDA is not exercising
sufficient efforts to satisfy the diligence obligations set forth in
Section 5.1, MAYO shall initiate a Short-Form Arbitration proceeding
pursuant to Section 5.4 within 30 days thereafter.  The sole question before the arbitrator
shall be whether ACORDA is exercising sufficient efforts to satisfy the diligence
obligations set forth in Section 5.1. 
If MAYO fails to initiate such arbitration within such 30 day period,
MAYO shall have no further right to dispute ACORDA’s efforts to satisfy its
diligence obligations with respect to the period in question.


 


(d)                                 The
foregoing is intended to provide MAYO the means to reasonably exercise its
rights hereunder, and shall not be used to place unreasonable reporting burdens
on ACORDA.  MAYO may not commence a
request for the foregoing information from ACORDA for at least one year after
MAYO last commenced a request therefor.


 


5.3                                 Short-Form Arbitration.  Any dispute subject to short-form
arbitration as provided in Section 5.3 shall be finally settled by binding
arbitration in New York City, New York (at a specific location to be agreed
upon by the Parties) under the Licensing Rules of the American Arbitration
Association by a panel of one or more arbitrators, who shall have experience
and be knowledgeable in the pharmaceutical industry, appointed in accordance
with such rules.(Such arbitrators shall make their determination on the basis
of “baseball arbitration” principles. 
THE FOREGOING REMEDY SHALL BE EACH PARTY’S SOLE AND EXCLUSIVE REMEDY
WITH RESPECT TO ANY SUCH DISPUTE. 
Except as specifically otherwise set forth in Section 5.3 and this
Section 5.4 such arbitration shall be conducted in accordance with the
provisions of Exhibit D.


 


12

















 


6.                                      “OWNERSHIP; PATENTS; MARKETING
EXCLUSIVITY; PATENT TERM EXTENSIONS”


 


6.1                                 Ownership.


 


(a)                                  Except
as otherwise provided in Section 6.1(b) through (e), MAYO shall retain all
right, title and interest in and to the Licensed Technology, regardless of
which Party prepares and prosecutes the patent applications associated
therewith, or maintains the patents or other intellectual property rights
related, subject to the right and license granted to ACORDA pursuant to
Section 2.


 


(b)                                 Rights
to Inventions for which employees or agents of MAYO are the sole inventor(s) as
determined in accordance with U.S. 
patent laws shall belong to MAYO.


 


(c)                                  Rights
to Inventions for which employees or agents of ACORDA are the sole inventor(s)
as determined in accordance with U.S. 
patent laws shall belong to ACORDA.


 


(d)                                 Rights
to Inventions made jointly by employees and agents of MAYO and by employees and
agents of ACORDA as determined in accordance with U.S.  patent laws shall belong jointly to MAYO and
to ACORDA.


 


(e)                                  Rights
held by MAYO in any Inventions, including without limitation, rights in and to
patent applications and patents which may be obtained thereon, shall be within
the terms Licensed Patents and shall be subject to the license granted to
ACORDA herein.


 


(f)                                    In
the event as to any Invention either Party determines that it may be advisable
to consider special ownership or license arrangements among them in order to
maximize the commercial protection or utility afforded under any applicable
patent law, the Parties shall discuss and consider in good faith the
implementation of such special arrangements as a means of maximizing the value
of such Invention for their mutual benefit.


 


6.2                                 Patent Prosecution and Maintenance.


 


(a)                                  ACORDA,
at its sole cost and expense (including, without limitation, legal fees, filing
and maintenance fees or other governmental charges), shall (i) commencing on
the Effective Date, have full responsibility for and shall control the
preparation and prosecution of all patent applications, and the maintenance of
all patents, related to the Licensed Technology, and (ii) reimburse the
reasonable expenses in connection with such activities prior to the Effective
Date.  actually incurred by MAYO, in
connection with the filing, prosecution and maintenance of the Patent Rights,
as shown by MAYO’s books and records.


 


(b)                                 ACORDA
shall select qualified patent counsel to file and prosecute all such patent
applications.  ACORDA shall provide
copies to MAYO of any proposed filings to made to any patent office relating to
the Patent Rights in advance, shall consult with MAYO, and shall in good faith
consider and give due respect to MAYO’s position with respect thereto.  In addition, ACORDA shall provide copies to
MAYO of any written communications received from any patent office relating to
the Patent Rights.


 


13

















 


(c)                                  MAYO
shall provide ACORDA with a credit against earned royalties due MAYO in the
amount of fifty percent (50%) of all expenses, costs and fees (including
attorney’s fee’s) paid by ACORDA in pursuant to this Section 6.2.  At MAYO’s request, ACORDA shall provide MAYO
with reasonable documentation of such costs.


 


(d)                                 Each
Party agrees to cooperate with the other Party to execute all lawful papers and
instruments, to make all rightful oaths and declarations and to provide
consultation and assistance as may be necessary in the preparation,
prosecution, maintenance, and enforcement of all Patent Rights.


 


6.3                                 Patent Enforcement.


 


(a)                                  If
either Party learns of an infringement or other use, rights or ownership claim
or threatened infringement or other such claim by a third party with respect to
any Licensed Technology within the Territory, such Party shall promptly notify
the other Party and shall provide such other Party with available evidence of
such infringement, whereupon the parties shall consult to determine if they
will jointly bring action to terminate such infringement or
misappropriation.  The costs and
expenses of any such action (including fees of attorneys and other
professionals) shall be borne by the Parties in such proportions as they may
agree in writing.  Any recovery obtained
by the Parties in such action shall be used to reimburse the cost of such
action to the Parties in proportion to their respective contributions to the
costs and expenses incurred in such action, and the remainder shall be divided
equally between the Parties.


 


(b)                                 In
the event that the Parties fail to initiate an action to terminate such
infringement or misappropriation within ninety (90) days after the last party
receives notice of such infringement or misappropriation, MAYO shall have the
first right, but not the duty, to institute at its sole cost and expense,
actions against third parties based on any Licensed Technology under this
Agreement.  Any recovery obtained by MAYO
in such action shall be used to reimburse the cost of such action and the
remainder shall be retained by MAYO.


 


(c)                                  In
the event that the Parties fail to initiate an action to terminate such
infringement or misappropriation within ninety (90) days after the last party
receives notice of such infringement or misappropriation, and in the event MAYO
does not institute an infringement proceeding against an offending third party
within 180 days after the last party receives such notice, ACORDA shall have
the right, but not the duty, to institute at its sole cost and expense, such an
action with respect to any infringement or misappropriation by a third
party.  Any recovery obtained by ACORDA
shall be used to reimburse the cost of such action and the remainder shall be
retained by ACORDA, provided however, that
such amount shall be deemed to constitute Net Sales for purposes of this
Agreement.


 


(d)                                 Unless
the Parties otherwise agree in writing, each Party shall execute all necessary
and proper documents and provide reasonable, but not financial, cooperation as
shall be appropriate, to allow the other Party to institute and prosecute such
infringement actions.


 


6.4                                 Infringement Action by Third Parties.


 


(a)                                  In
the event of the institution of any suit by a third party against ACORDA for
patent infringement involving the manufacture, sale, offer for sale,
distribution or marketing


 


14

















 


of any Product in the Territory, ACORDA shall have the
right to defend such suit at its own expense, and MAYO hereby agrees to assist
and cooperate with ACORDA, at ACORDA’s expense, to the extent necessary in the
defense of such suit.  During the
pendency of any such action, ACORDA shall continue to make all payments due
under this Agreement, provided however, that
ACORDA shall be entitled to a credit against such payments of an amount equal
to one-half of the reasonable costs actually incurred in such action.


 


(b)                                 If
ACORDA finally prevails and receives an award from such third party as a result
of such action (whether by way of judgment, award, decree, settlement or
otherwise), such award shall be allocated, first, to ACORDA and MAYO to
reimburse each Party for its pro rata share of costs and expenses incurred in
such action, and the remaining amount shall be retained by ACORDA, provided however, that such amount shall
be deemed to constitute Net Sales for purposes of this Agreement.


 


(c)                                  If
ACORDA finally loses, whether by judgment, award, decree or settlement, and is
required to pay a royalty or damages to such third party, ACORDA shall continue
to pay the royalties for such Licensed Product in the country(ies) which is the
subject of such action, but shall be entitled to a credit against such payments
in an amount-equal to the royalty or damages paid to such third party, but in
no event shall such credit be more than 50% of the royalties due hereunder for
such Licensed Product in such country(ies).


 


(d)                                 If
ACORDA is required to pay a royalty or damages to a third party pursuant to
Section 6.4(c) and the amount of such royalty or damages exceeds 50% of
the royalties due hereunder for such Licensed Product in such country(ies),
ACORDA shall have the right to terminate this Agreement solely with respect to
such Licensed Product in such country(ies). 
The effect of any such termination shall be the same as any termination
by ACORDA pursuant to Section 9.4.


 


6.5                                 Marketing Exclusivity/Patent
Term Extensions


 


(a)                                  ACORDA
shall be responsible for taking all necessary steps to prosecute, perfect and
maintain such applicable Marketing Exclusivity Rights as it deems appropriate.


 


(b)                                 ACORDA
grants to MAYO the exclusive right to rely on any Regulatory Review Period for
any Licensed Product and agrees to be MAYO’s agent for such purposes.  In the event of any request from the Patent
and Trademark Office for assurances that MAYO has the right to rely on the
Regulatory Review Period, including assurances that ACORDA is MAYO’s agent for
such purposes, this Section 6.5 shall be conclusive evidence ofACORDA’s
agreement that MAYO has such right.  Except
as may otherwise be contemplated under this Agreement with respect to the
transfer of rights or obligations to Affiliates, Sublicensees and permitted
assignees, ACORDA may not transfer, assign, license, mortgage or hypothecate in
whole or in part to any person, whether voluntarily or involuntarily, its right
to a Regulatory Review Period for any Licensed Product without the prior
written consent of MAYO, which consent shall not be unreasonably withheld or
delayed.


 


(c)                                  Subject
to the provisions of Section 6.5 (e), MAYO reserves the right to determine
that ACORDA should file and prosecute any application for a Patent Term
Extension;


 


15

















 


(d)                                 ACORDA
agrees to take all reasonable actions which MAYO determines to be necessary to
ensure the complete and timely filing and prosecution of any application for a
Patent Term Extension, including but not limited to providing MAYO with
relevant Patent Term Extension Information.


 


(e)                                  In
the event that more than one Licensed Patent could be the subject of an
application for a Patent Term Extension, ACORDA shall have the right, after
consultation with MAYO, to select the Licensed Patent.


 


7.                                      PUBLICATION; CONFIDENTIALITY.


 


7.1                                 Publication. 
ACORDA acknowledges that MAYO is dedicated to free scholarly exchange
and to public dissemination of the results of its scholarly activities.  In the event MAYO, or any employee, student
or other agent of MAYO who is performing any work with respect to the Program,
wishes to make any publication or otherwise disseminate information concerning
or obtained through the Program, MAYO will deliver to ACORDA copies of such
scientific articles, papers and abstracts for review and comment at least 60
days prior to the date of submission for publication or presentation.  ACORDA’s permission to publish shall not be
unduly withheld, and ACORDA’s permission or withholding of such permission will
be submitted to MAYO in writing not later than 30 days following’ ACORDA’s
receipt of the material for review.  If
ACORDA determines that such proposed publication or presentation contains
patentable subject matter that requires protection, ACORDA may require the
delay of publication or presentation for a period not to exceed 90 days for the
purpose of allowing the filing of patent applications.  If ACORDA identifies any of ACORDA’s
Confidential Information (as defined herein) in such proposed publication or
presentation, MAYO will delete such information from same, or modify the
disclosure of such information from same in a manner reasonably acceptable to
ACORDA.


 


7.2                                 Confidentiality; Exceptions.


 


(a)                                  “Confidential
Information of a party shall mean all reports, data and information disclosed
by such party to another party, which is (i) in writing and marked “CONFIDENTIAL”
or “PROPRIETARY or marked with words of similar import, or (ii) disclosed
through oral, visual, or other non-written means, identified as confidential or
proprietary at the time of initial disclosure, and summarized and confirmed as
confidential or proprietary in writing to the receiving party within thirty
(30) days of such disclosure.  Any
markings, stamps, or legends identifying confidential information shall not
impose any obligations on either party inconsistent with this agreement.  Any copies of the information made by the
receiving party shall reproduce the confidential markings and any other legends
contained on such information.


 


(b)                                 Except
to the extent expressly authorized by this Agreement or otherwise agreed in
writing, the Parties agree that, during the term of this Agreement and for five
years thereafter, the receiving Party, its Affiliates, its licensees and its
Sublicensees shall keep, and shall ensure that their respective employees,
officers, directors and trustees shall keep, completely confidential and shall
not publish or otherwise disclose and shall not use any


 


16

















 


Confidential Information for any purpose other than
carrying out the obligations of the receiving Party under this Agreement except
to the extent that it can be established by the receiving Party by competent
proof in the form of written records maintained by the receiving Party that
such information: (i) was already known to the receiving Party, other than
under an obligation of confidentiality, at the time of disclosure by the
disclosing Party; (ii) was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the receiving Party;
(iii) became generally available to the public or otherwise part of the public
domain after its disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement; or (iv) was disclosed to the
receiving Party, other than under an obligation of confidentiality, by a third
party who had no obligation to the disclosing Party not to disclose such
information to others.


 


7.3                                 Exceptions to Obligation.  The restrictions contained in
Section 7.2 shall not apply to Confidential Information that: (i) is
submitted by the recipient to governmental authorities to facilitate the
issuance of marketing approvals for Licensed Products, provided that reasonable
measures shall be taken to assure confidential treatment of such information;
(ii) is provided by the receiving Party to third parties under appropriate
terms and conditions, including confidentiality provisions substantially
equivalent to those in this Agreement, for consulting, manufacturing
development, manufacturing, external testing and marketing trials; or (iii) is
otherwise required to be disclosed in compliance with applicable laws or
regulations or order by a court or other regulatory body having competent
jurisdiction, provided that if a Party is required to make any such disclosure
of the other Party’s Confidential Information it will, except where
impracticable for necessary disclosures, for example to physicians conducting
studies or to health authorities, give reasonable advance notice to the other
Party of such disclosure requirement and, except to the extent inappropriate in
the case of patent applications, will use its best efforts to secure
confidential treatment of the Confidential Information required to be
disclosed, and shall cooperate with efforts of the disclosing Party to limit
disclosure, as appropriate.


 


7.4                                 Confidentiality regarding
Patient Information. 
Notwithstanding anything in this Section 7 to the contrary,
identifiable patient information obtained in the performance of the Program
shall be deemed Confidential Information and shall be kept confidential by both
Parties permanently except: (i) when that information is required to be
disclosed by regulatory authorities; or (ii) with the patient’s consent.


 


8.                                      INDEMNIFICATION.


 


8.1                                 Products Liability.  ACORDA shall defend, indemnify and hold MAYO
and MAYO’s Affilitates, and their respective trustees, officers and employees,
harmless from and against any and all claims, suits or demands for liability,
damages, losses, costs and expenses (including the costs and expenses of
attorneys and other professionals) (collectively, a “Claim”) arising out of or
resulting from third party claims or suits resulting from: (i) the use by
ACORDA or its Affiliates or Sublicensees of any of the Licensed Technology,
(ii) the use by ACORDA or its Affiliates or Sublicensees of information
concerning or obtained through the Program, or (iii) the manufacture, use, sale
or offer for sale of a Licensed Product by ACORDA or its Affiliates or
Sublicensees pursuant to this Agreement; provided that such Claim does not
arise out of or result from a breach of any of MAYO’s representations or
warranties made under


 


17

















 


this Agreement, and provided further that such Claim
is not covered by MAYO’s indemnification provided in Section 8.2.


 


ACORDA shall, during the
term of this Agreement, carry occurrence-based liability insurance with policy
limits of at least THREE MILLION DOLLARS ($3,000,000).  In addition, such policy shall name MAYO as
an additional-named insured.


 


8.2                                 MAYO Indemnification.


 


(a)                                  MAYO
shall defend, indemnify and hold ACORDA and its Affiliates and Sublicensees and
their respective directors, officers and employees, harmless from and against
any and all Claims arising out of or resulting from third party claims or suits
resulting from (a) any negligence, recklessness or wrongful intentional acts or
omissions of MAYO and its trustees, officers, employees and agents, including
Dr.  Moses Rodriguez and Dr.  Larry Pease in connection with (i) the work
performed by MAYO, Dr.  Moses Rodriguez
or Dr.  Larry Pease under the Program,
and (ii) any other development and/or commercialization work relating to any
Licensed Products or Licensed Technology before the Effective Date, or
thereafter in connection with MAYO’s, Dr. 
Rodriguez’ or Dr.  Pease’s
development of Licensed Products or Licensed Technology; excepting in any case
to the extent any such Claims result from the negligence, recklessness or
wrongful intentional acts or omissions of ACORDA or its Affiliates or
Sublicensees, or their respective directors, officers, employees or agents.


 


(b)                                 Notwithstanding
any other provision of this Agreement, including those which may impose any
obligation or cost on ACORDA in ‘connection with patent prosecution,
enforcement and infringement actions from third parties under Section .6,
MAYO shall defend, indemnify and hold ACORDA and its Affiliates and
Sublicensees and their respective directors, officers and employees, harmless
from and against any and all Claims arising out of or resulting from third
party claims or suits resulting from or in any way related to the TEVA
Agreement and MAYO shall, at its sole expense, take all reasonable actions and
adopt all reasonable positions with third parties in order to permit ACORDA
full enjoyment of the exclusive license granted under this Agreement and to
avoid or mitigate any conflicts between with the license hereunder and any
rights which MAYO may have granted under the TEVA Agreement in ACORDA’s favor.


 


8.4                                 Notice; Waiver of Subrogation.


 


(a)                                  In
the event that any person entitled to indemnification (an “Indemnitee”) seeks
indemnification under this Section 8, the Indemnitee agrees to: (i)
promptly inform the indemnifying Party (the “Indemnitor”) of any claim, suit or
demand threatened or filed, (ii) permit the Indemnitor to assume direction and
control of the defense or Claims resulting therefrom (provided that Indemnitor
may not settle any Claim against an Indemnitee without the consent of the
Indemnitee, which consent shall not be unreasonably withheld), and (iii)
cooperate as requested (at the expense of the Indemnitor) in the defense of the
Claim.


 


(b)                                 Except
as otherwise expressly provide in this Agreement, each Indemnitor waives any
right of subrogation that it may have against an Indemnitee resulting from any
Claim for which an Indemnitor has agreed to indemnify an Indemnitee under
Section 8 of this


 


18

















 


Agreement. 
Such waiver shall not, however, be deemed a waiver of any subrogation
rights an Indemnitor may have against third parties.


 


9.                                      TERM AND TERMINATION.


 


9.1                                 Term.  This
Agreement shall commence as of the Effective Date and, unless sooner terminated
as provided hereunder, shall expire as follows:


 


(a)                                  As
to each Licensed Product and as to each country in the Territory, on a
country-by-country and Licensed Product-by-Licensed Product basis upon the
expiration of the last to expire Licensed Patent in such Licensed Product or in
such country, as the case may be.


 


(b)                                 This
Agreement shall terminate in its entirety upon its termination as to all
Licensed Patents in all countries.


 


9.2                                 Breach.  A
Material Breach by either Party of any of the obligations contained in this
Agreement shall entitle the other Party to give to the Party in default notice
specifying the nature of the Material Breach and requiring it to cure such
Material Breach.  If such Material
Breach is not cured within 90 days after the receipt of such notice (or, if
such Material Breach reasonably cannot be cured within such 90-day period, if
the Party in default does not commence and diligently continue actions to cure
such default during such 90-day period), the notifying Party shall be entitled,
without prejudice to any of the other rights conferred on it by this Agreement,
and in addition to any other remedies available to it at law or in equity, to
terminate this Agreement by giving written notice to take effect on the date of
such notice.  The right of either Party
to terminate this Agreement, as provided in this Section 9.2, shall not be
affected in any way by its waiver or failure to take action with respect to any
previous Material Breach.


 


9.3                                 Insolvency or Bankruptcy.  In the event that either Party shall become
insolvent, shall make an assignment to the benefit of creditors, or shall have
a petition in bankruptcy filed for or against it (which, in the case of an
involuntary petition, is not dismissed or stayed within sixty (60) days after
such petition is.filed) (a “Bankrupt Party”), the other Party shall have the
right to terminate this Agreement in its entirety immediately upon written
notice of such Termination.  All rights
and licenses granted by the Bankrupt Party under this Agreement are, and shall
otherwise be deemed to be; for purposes of Section 365(n) of Title 11, US
Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as
defined under Section 101(60) of the Bankruptcy Code.  Unless the other Party elects to terminate
this Agreement under this Section, the Parties agree that the other Party, as a
licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code, subject to
the continued fulfillment of its obligations under this Agreement.


 


9.4                                 Termination by ACORDA.  ACORDA shall have the right to terminate the
right and license granted herein, in whole or as to any Licensed Product in any
country in the Territory, at any time, and from time to time, by giving written
notice to MAYO.  Such termination shall
be effective 90 days from the date such notice is given, and all of ACORDA’s
rights associated with such Licensed Product(s) and such country(ies) shall
cease as of that date, subject to Sections 9.5 through 9.7.


 


19

















 


9.5                                 Right to Sell Stock on Hand.  Upon the termination of any right and
license granted herein, in whole or as to any Licensed Product, for any reason
other than ACORDA’s failure to cure a Material Breach of this Agreement, ACORDA
shall have the right for one year or such longer period as the Parties may
reasonably agree in writing to dispose of all Licensed Products or
substantially completed Licensed Products then on hand to which such
termination applies, and royalties shall be paid to MAYO with respect to such Licensed
Products as though this Agreement had not terminated.


 


9.6                                 Effect of Termination.


 


(a)                                  Following
the expiration of any right and license granted under this Agreement in whole
or in part as to any Licensed Product in any country in the Territory pursuant
to Section 9.1, ACORDA shall have the royalty-free, non-exclusive right to
continue to use the Licensed Technology for the manufacture, use and sale of
Licensed Products as theretofore licensed under this Agreement.


 


(b)                                 Upon
Termination of this Agreement by ACORDA pursuant to Section 9.2 or 9.3:
(i) MAYO shall promptly transfer to ACORDA copies of all data, reports, records
and materials in MAYO’s possession or control that relate to the Licensed
Products and return to ACORDA all relevant records and materials in MAYO’s
possession or control containing Confidential Information ofACORDA, including
all information concerning or obtained through the Program; (ii) ownership of
all INDs, PLAs and other regulatory filings made or filed for any Product shall
be transferred solely to ACORDA, and (iii) at ACORDA’s election, any
sublicenses granted by ACORDA under the Licensed Technology shall be deemed
terminated or automatically assigned to MAYO.


 


(c)                                  Upon
Termination of this Agreement by MAYO pursuant to Section 9.2 or 9.3: (i)
ACORDA shall promptly transfer to MAYO copies of all data, reports, records and
materials in ACORDA’s possession or control that relate to the Licensed
Products and return to MAYO all relevant records and materials in ACORDA’s possession
or control containing Confidential Information of MAYO; (ii) all licenses
granted for Licensed Technology by MAYO to ACORDA under Section 2 shall
terminate; (iii) all sublicenses granted by ACORDA under the Licensed
Technology shall be deemed automatically assigned to MAYO.  Thereafter, MAYO shall have the right to
develop, make, have made, use, sell or have sold any Licensed Product.


 


(d)                                 Upon
Termination of this Agreement by ACORDA pursuant to Section 9.4: (i) each
Party shall promptly transfer to the other Party copies of all data, reports,
records and materials of the other Party in the possession or control of such
Party that relate to the Licensed Products; (ii) each Party shall promptly
return to the other Party all relevant records and materials in such Party’s
possession or control containing Confidential Information of the other Party;
and (ii) all licenses granted by either Party to the other Party under
Section 2 shall terminate. 
Thereafter, each Party shall have the right to develop, make, have made,
use, sell or have sold any Licensed Product, to the extent legally permissible.


 


9.7                                 Accrued and Surviving Rights and
Obligations. 
Termination, relinquishment or expiration of this Agreement for any
reason shall be without prejudice to any rights, obligations or liabilities
which shall have accrued to the benefit of either Party prior to such
Termination, relinquishment or expiration (including, without limitation,
ACORDA’s obligation to pay all


 


20

















 


royalties which shall have accrued hereunder as of the
effective date of such Termination). 
The Parties’ rights and obligations under Sections 4, 6, 7, 8, 9.5, 9.6,
9.7, 10.5, and 10.12 shall survive Termination.


 


10.                               MISCELLANEOUS PROVISIONS.


 


10.1                           Relationship of Parties.  Nothing in this Agreement is intended or
shall be deemed to constitute• a partnership, agency,
employer-employee or joint venture relationship between the Parties.  No Party shall incur any debts or make any
commitments for the other, except to the extent, if at all, specifically
provided herein.


 


10.2                           Assignment. 
Except as otherwise provided herein, neither this Agreement nor any
interest hereunder shall be assignable by any Party without the prior written
consent of the other, which consent shall not be unreasonably withheld; provided, however, that either Party may
assign this Agreement to any wholly-owned subsidiary or to any successor by
merger or sale of substantially all of those of its assets to which this
Agreement relates in a manner such that the assignor shall remain liable and
responsible for the performance and observance of all its duties and
obligations hereunder.  This Agreement
shall be binding upon the successors and permitted assigns of the Parties, and
the name of a Party appearing herein shall be deemed to include the names of
such Party’s successors and permitted assigns to the extent necessary to carry
out the intent of this Agreement.  Any
assignment not in accordance with this Section 10.2 shall be void.


 


10.3                           Further Actions.  Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement..


 


10.4                           Force Majeure. 
Neither Party shall be liable to the other for loss or damages or shall
have any right to terminate this Agreement for any default or delay
attributable to any act of God, flood, fire, explosion, strike, lockout, labor
dispute, shortage of raw materials, casualty or accident, war, revolution,
civil commotion, act of public enemies, blockage or embargo, injunction, law,
order, proclamation, regulation, ordinance, demand or requirement of any
government or subdivision, authority or representative of any such government,
or any other.  cause beyond the
reasonable control of such Party, if the Party affected shall give prompt
notice of any such cause to the other Party. 
The Party giving such notice shall thereupon be excused from such of its
obligations hereunder as it is thereby disabled from performing for so long as
it is so disabled and for 30 days thereafter.


 


10.5                           No Trademark Rights.  Except as otherwise provided herein, neither
Party shall have any right, express or implied, to use in any manner, in
connection with the performance of this Agreement, the name or other
designation of the other Party or any other logo, name, tradename, service mark
or trademark of the other Party, or the name of any employee or agent of the
other Party, without that Party’s prior, written, express consent.  Either Party may withhold such consent in
either Party’s absolute discretion.  For
MAYO or its Affiliates, such names and marks include, but are not limited to,
the terms “Mayo®,” “Mayo Clinic®,” or any simulation, abbreviation, or
adaptation of the same.  Violation of
this Section 10.5 by either


 


21

















 


Party shall be deemed a Material Breach of this
Agreement, entitling the other Party to appropriate equitable or legal relief.


 


10.6                           Public Announcements.  Except as required by law, including but not
limited to, disclosures to prospective investors as required under applicable
state and federal securities laws or as. 
required for documents or other communications to be filed or distributed
pursuant to requirements of the Securities and Exchange Commission, any stock
exchange or NASDAQ, (“Permitted Public Announcement”) neither party shall make
any public announcement concerning this Agreement or the subject matter hereof
without the prior written consent of the other to the text of such public
announcement.  In the event of a
Permitted Public Announcement, the Party making such announcement shall provide
the other with a copy of the proposed text prior to such announcement.  In the event that a party has obtained
consent to the text of such other public announcement, such party shall be
entitled to use and reuse, without limitation and in any form, such text in one
or more public announcements.


 


10.7                           Notices.  All
notices and other communications required or permitted to be given under or in
connection with this Agreement shall be in writing, and shall be deemed given
if delivered personally or by facsimile transmission (receipt verified),
express courier service (signature required), or mailed by registered or
certified mail (return receipt requested), postage prepaid, to the Parties at
the following addresses (or at such other address for a Party as shall be
specified by like notice; provided, that notices of a change or address shall be
effective only upon receipt thereof):


 


	
  (a)

  	
  If to ACORDA, to:

  
	
   

  	
   

  
	
   

  	
  ACORDA THERAPEUTICS,
  INC.

  
	
   

  	
  15 Skyline Drive

  
	
   

  	
  Hawthorne, New York
  10532

  
	
   

  	
  Attention: President

  
	
   

  	
  Facsimile No.:
  (914)347-4560

  
	
   

  	
   

  
	
  (b)

  	
  If to MAYO, to:

  
	
   

  	
   

  
	
   

  	
  MAYO FOUNDATION FOR
  MEDICAL EDUCATION AND RESEARCH

  
	
   

  	
  200 First Street, SW

  
	
   

  	
  Rochester, Minnesota
  55905

  
	
   

  	
  Attention: Office of
  Technology Commercialization, Mayo Medical Ventures

  
	
   

  	
  Facsimile No.:
  507-284-5410

  



 


If delivered personally
or by facsimile transmission, the date of delivery shall be deemed to be the
date on which such notice or request was given.  If sent by overnight express courier service, the date of
delivery shall be deemed to be the next business day after such notice or
request was deposited with such service. 
If sent by registered or certified mail, the date of delivery shall be
deemed to be the third business day after such notice or request was deposited
with the U.S.  Postal Service.


 


10.8                           Amendment. 
No amendment, modification or supplement of any provision of this Agreement
shall be valid or effective unless made in writing and signed by a duly
authorized officer of each Party, and specifically referencing this Agreement.


 


22

















 


10.9                           Waiver.  No
provision of this Agreement shall be waived by any act, omission or knowledge
of a Party or its agents or employees except by an instrument in writing
expressly waiving such provision and signed by the waiving Party.


 


10.10                     Severability. 
Whenever possible, each provision of this Agreement will be interpreted
in such manner as to be effective and valid under applicable law, but if any
provision of this Agreement is held to be prohibited by or invalid under
applicable law, such provision will be ineffective only to the extent of such
prohibition or invalidity, without invalidating the remainder of this
Agreement.


 


10.11                     Compliance with Law.  Nothing in this Agreement shall be deemed to
permit a Party to export, reexport or otherwise transfer any Know-How
transferred hereunder or Licensed Products manufactured therefrom without
compliance with applicable laws.


 


10.12                     Governing Law and Jurisdiction.  This Agreement shall be governed by
Minnesota law, but specifically not including Article 2 of the Uniform
Commercial Code as enacted in Minnesota. 
This is not a contract for the sale of goods.  In addition, no Minnesota conflicts-of-law or choice-of-laws
provisions apply to this Agreement.  To
the extent the substantive and procedural law of the United States would apply
to this Agreement, it supersedes the application of Minnesota law.  The parties agree that all disputes between
them concerning this contract, other than as
provided for in Section 5.4 hereto, whether arising before or after
Termination, will be settled only according to the arbitration process
described in Exhibit D, attached to and incorporated into this Agreement, and
not through any action at law or in equity, except as otherwise permitted under
Exhibit D.


 


10.13                     Entire Agreement of the Parties.  This Agreement, including the exhibits
attached, constitutes and contains the entire understanding and agreement of
the Parties and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether oral or written, between
the Parties respecting the subject matter hereof.


 


10.14                     Descriptive Headings.  The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.


 


10.15                     Nondisclosure. 
Neither Party shall disclose any of the terms of this Agreement without
the express, prior, written consent of the other Party, or unless required by
law.


 


10.16                     Counterparts. 
This Agreement maybe executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
agreement.


 


* * *


 


23

















 


IN WITNESS WHEREOF, each
of the Parties has caused this License Agreement to be signed by its duly authorized
representative as of the date first written above.


 


 


	
   

  	
  ACORDA THERAPEUTICS

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Ron Cohen

  	
   

  
	
   

  	
   

  
	
   

  	
  Name: Ron Cohen

  
	
   

  	
   

  
	
   

  	
  Title: President and
  CEO

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  MAYO FOUNDATION FOR
  MEDICAL

  EDUCATION AND RESEARCH

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Rick F. Colvin

  	
   

  
	
   

  	
   

  
	
   

  	
  Name: Rick F.  Colvin

  
	
   

  	
   

  
	
   

  	
  Title:  Assistant
  Treasurer

  
						



 


24