Document:

Exhibit
10.17

 

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

 

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:

 

[**]

 

22Exhibit
10.18

 

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

 

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

 

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.

 

Exhibit C

 

Remvelination Monoclonal
Antibody Cases

 

	
  PCT/U.S. Serial No.

  	
   

  	
  Title of Application

  	
   

  	
  Date of Filing

  
	
  US#5,591,629

  	
   

  	
  Monoclonal
  Antibodies Which Promote Central Nervous System Remyelination

  	
   

  	
  4/29/94

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  4/27/95

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  8/8/96

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  1/7/97

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  5/28/99

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  5/30/00

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  5/10/00

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  5/30/00

  

 

 

 

EXHIBIT D

 

MANDATORY
MEDIATION AND BINDING ARBITRATION

 

1.             NOTICE OF DISPUTE. Except to the extent otherwise expressly
provided in Sections 5.3 and 5.4 of this Agreement, any dispute related to this
Agreement between the Parties, including its formation, performance, or
Termination, which cannot be resolved by the Parties themselves within thirty
(30) clays of written notice by one Party to the other of the existence of a
dispute, may be referred by either of the parties to mandatory mediation and
binding arbitration under the terms of this Exhibit. The Parties intend the
mediation/arbitration procedure described in this Exhibit to substitute in all
cases for litigation related to any such dispute, subject only to part 7,
below, and this agreement to submit all such disputes to mandatory mediation
and binding arbitration is irrevocable.

 

2.             LIMITATION PERIOD. No demand for mediation/arbitration may
be made regarding any claim more than one hundred eighty (180) days after
written notice by one Party to the other of the existence of a dispute,
regardless of any otherwise applicable statute of limitations.

 

3.             MEDIATOR/ARBITRATOR. If the Parties cannot agree upon a
single mediator/arbitrator within fourteen (14) days after written demand by
either of them for mediation/arbitration, then a single mediator/arbitrator
shall be chosen by the American Arbitration Association office in New York
City, New York, within thirty (30) additional days after the fourteen (14) day
period. The mediator/arbitrator shall be generally experienced in the legal and
technical matters related to the dispute.

 

4.             MEDIATION. Within thirty (30) days of the appointment of the
mediator/arbitrator, the Parties must attend a mediation session at which the
mediator/arbitrator personally shall attempt to guide the Parties to a
settlement. Each Party may be represented by counsel at the mediation, but each
Party must attend through an officer having authority to agree to a settlement
at the mediation. The mediation session shall occur in New York City, New York,
and shall extend no longer than a single day. Statements or offers made at the
mediation session shall not be admissible in any later arbitration hearing.

 

5.             ARBITRATION. If such mediation has not resulted in a
mutually-executed settlement agreement (or withdrawal of claim) within five (5)
business days after the date of mediation, then the Parties shall proceed to
arbitration as described below. Such arbitration, which the Parties intend to
be final and to substitute for litigation, shall occur in New York City, New
York, and the arbitration results maybe entered as a final judgment in any
court with jurisdiction. The decision of the arbitrator shall be final and
binding upon the Parties both as to law and fact.

 

(a)           Initial Disclosures. Within
twenty-one (21) days after the date of mediation, the Parties shall exchange
written disclosures listing with reasonable specificity: (i) all exhibits
expected to be used by the Party at arbitration, and complete copies of such
exhibits, (ii) all witnesses expected to be called by the Party at arbitration,
and (iii) the substance of the testimony of each witness. Copies of such
disclosures shall be sent to the arbitrator. No exhibit or witness may be
called if the same does not appear on such disclosure, and 

 

 

 

 

no witness may testify as to matters not described in
such disclosure, except for rebuttal testimony as may be permitted by the
arbitrator.

 

(b)           Discovery Period. Within fourteen
(14) days after exchange of the disclosure notices, the Parties shall make
specific discovery requests to the arbitrator, and within an additional
fourteen (14) days the arbitrator shall issue to both parties a joint discovery
order. The discovery period preceding the arbitration hearing shall not exceed
sixty (60) days from the issuance of the discovery order by the arbitrator.

 

(c)           Scope of Discovery. Discovery shall
be limited to that ordered by the arbitrator as being reasonable and necessary,
and in no case shall exceed the deposition of two (2) witnesses for each Party,
and/or the exchange of more than a total of twenty-five (25) specific and
non-compound interrogatories by each party, and/or two specific requests by
each Party for the production of documents considered by the arbitrator to be
reasonably relevant and not unduly burdensome.

 

(d)           Hearing. The arbitration hearing,
which shall be confidential to the parties and not open to the public, shall
not exceed two (2) separate days, and shall be completed within thirty (30)
days of the close of discovery. The arbitrator may admit any testimony or other
evidence which the arbitrator decides is reasonably relevant to the issues of
the arbitration, but excluding statements or offers made by either Party at the
mediation session.

 

(e)           Final Decision. The arbitrator shall
issue a final written decision no later than sixty (60) days following the end
of the arbitration hearing, stating findings as to law and fact. The decision
shall be confidential to the Parties. The arbitrator shall be limited to
determining and ordering the payment of actual and direct damages if any, and
may order the payment of indirect, special, incidental, or consequential
damages only where bad faith has been shown and/or to the extent required to
fulfill any obligations under Article 8 of the Agreement. The arbitrator shall
not order the payment of punitive or exemplary damages in any case.

 

6.             COSTS AND FEES. Both Parties shall be responsible for their
own costs and fees (including attorney’s fees), and shall divide common costs
and fees equally; however, if the arbitrator specifically finds bad faith on
the Part of either Party, then the arbitrator may order a different division of
costs and fees.

 

7.             EQUITABLE RELIEF. Nothing in this Exhibit prohibits either
Party from seeking equitable relief to protect its rights to the extent that
irreparable harm may occur and damages would not be a sufficient remedy, except
that neither Party shall seek to enjoin mediation/arbitration as described in
this Exhibit.

 

(a)           Specific Performance. Among the
equitable remedies that a Party may seek under this part 7, either Party may
petition a court for specific performance of the terms of this Exhibit,
including following the failure of either Party without good cause to adhere to
the time limits set out in this Exhibit. A Party securing an order for specific
performance 

 

 

2

 

 

under this part 7(a) is entitled to recover costs and
reasonable attorneys’ fees in connection with such petition for specific
performance and any related hearings.

8.             SURVIVAL. The rights and obligations of the Parties
described in this Exhibit survive the Termination, expiration, non-renewal, or
rescission of this Agreement.

9.             GOVERNING RULES AND LAW. To the extent not inconsistent with
the terms of this Exhibit, the mediation and arbitration are governed by the
rules of the American Arbitration Association, the Minnesota Arbitration Act,
and the Federal Arbitration Act (9 U.S.C s. 1 et seq.).

 

3

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