Exhibit 10.29


 


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.


 


 


CONFIDENTIAL


 


LICENSE AGREEMENT


 


THIS LICENSE
AGREEMENT (this “Agreement”), made the 17th day of April, 1991
by and between SANDOZ PHARMA LTD., a Swiss corporation having its principal
place of business at Lichtstrasse 35, CH-4002 Basle, Switzerland (“Sandoz Pharma”) and ATHENA NEUROSCIENCES, INC.
a Delaware corporation having its principal place of business at 800F Gateway
Boulevard, South San Francisco, California (“Licensee”),


 


WITNESSETH:


 


Whereas Sandoz Pharma has developed a substance called
Tizanidine, useful in the treatment of spasticity and/or spastic diseases and
owns and/or controls certain Know-How (as hereinafter defined) and patent
rights relating to Tizanidine;


 


Whereas Sandoz Pharma has certain processes, skills and
techniques for galenical formulations containing Tizanidine;


 


Whereas Licensee
desires to acquire from Sandoz Pharma a
license to sell Tizanidine and certain other rights on the terms and conditions
herein set forth;


 


Whereas Licensee
desires to purchase from Sandoz Pharma
finished pharmaceutical formulations containing Tizanidine for sale in the
Territory; and


 


Whereas Licensee
desires to clinically develop and market in the Territory finished
pharmaceutical formulations containing Tizanidine as the sole active
ingredient,


 


Now,
Therefore, In consideration of the premises and the mutual
covenants herein contained, it is mutually agreed as follows:


 


1.             Definitions.


 


1.1           “Affiliates” means any corporation of which a corporation
named herein owns, directly or indirectly, fifty percent (50%) or more of the
outstanding stock, or any corporation, partnership or other entity over which
such corporation named herein, directly or indirectly, exercises effective
control, or any parent corporation, partnership or other entity


 

















 


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.


 


 


which owns, directly or indirectly, fifty percent (50%) or more of the
outstanding stock of a party hereto, or, directly or indirectly, controls a
party hereto, and any corporation, partnership or other entity, other than a
corporation named herein, which, directly or indirectly, is controlled by such
parent corporation or other entity or of which such parent corporation or other
entity owns, directly or indirectly, fifty percent (50%) or more of the
outstanding stock.


 


1.2           “Compound” means S-chloro-4- (2-1 midazolin-2yl-amino) -2, 1,
3-benzo-thiadiazole-hydrochlorid, the specifications of which are defined in Schedule I
to this Agreement.


 


1.3           “FDA” means the United States Food and Drug Administration or
any successor thereof.


 


1.4           “Improvements” means inventions and discoveries related
specifically to Compound or Product, including, but not limited to:
new/additional indications other than spasticity, dosage forms, formulations,
delivery systems, process improvements, whether or not patentable, developed or
acquired by a party and/or its Affiliates during the term of this Agreement.


 


1.5           “IND” means Investigational New Drug.


 


1.6           “Know-How” means all data, instructions, processes, formulae,
expert opinions and information not generally known and relating to the
manufacture, use and/or sale of the Compound or Product currently in the
possession of, or developed during the term hereof, by either party or its
Affiliates pursuant to this Agreement. Know-How shall include, without
limitation, all biological, chemical, pharmacological, toxicological,
pharmaceutical, physical and analytical, safety, quality control, manufacturing
and clinical data and information relating to the use and/or sale of the
Compound or Product.


 


1.7           “NDA” means a New Drug Application as required pursuant to
the Code of federal regulations to be filed with the FDA.


 


1.8           “Net Sales” means the gross amount invoiced on sales of
Product by Licensee, its Affiliates and sublicensees to independent, third
party customers in bona fide, arms-length


 


2

















 


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


 


 


transactions less seven and one-half percent (7-1/2%) for (i) quantity
and/or cash discounts actually allowed or taken; (ii) amounts actually
repaid or credited by reasons of rejections or return of Product (e.g.,
recalls); (iii) freight, postage and insurance costs paid by Licensee or
its sublicensees for transporting Product from its warehouse to its customers;
and (iv) custom duties and sales taxes directly related to the sale.


 


1.9           “Product” means any finished oral pharmaceutical formulation
containing Compound as an active therapeutic ingredient.


 


1.10         “Purchase Requirements” means such quantities of Product in
form of bulk tablets as Licensee its Affiliates and its sublicensees have
committed for a particular quarter in accordance with Section 7.2.


 


1.11         “Territory” means the United States of America, its
territories and possessions (including Puerto Rico) and Canada.


 


2.             License.


 


2.1           Sandoz Pharma hereby grants to Licensee and
Licensee hereby accepts an exclusive license to develop, use and sell Product and
Improvements in the Territory in accordance with the terms and conditions set
forth in this Agreement. Licensee is entitled to grant sublicenses which right
shall only apply after an NDA has been filed.


 


Unless otherwise directed by Sandoz Pharma, the reference “under license from Sandoz Pharma Ltd.” or a similar reference
mutually agreed upon shall be included on Product labels and promotional
materials.


 


2.2           Licensee
shall bring Product to market through a thorough and diligent program for
exploitation of the right and license granted in this Agreement and to market
Product in the Territory all in accord with the efforts customarily given to
its other products.


 


3

















 


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


 


 


3.             Know-How
Transfer and Product Development.


 


3.1           Sandoz Pharma shall promptly following
execution of this Agreement furnish Licensee with (i) the Know-How except
such Know-How which is or shall be contained in the Drug Master File (DMF); (ii) a
letter to the FDA transferring to Licensee sponsorship of all Sandoz Pharma and/or its Affiliates’ IND
applications covering Product; and (iii) the complete file for Product
(currently in possession of Sandoz Canada).


 


3.2           Sandoz Pharma shall conduct all activities
related to pharmaceutical, physical and analytical studies, provide a DMF and
the chemistry, manufacturing and controls section of the to publish such
information.  To the extent that Licensee
can justify its inclusion, Licensee shall provide appropriate credits
identifying Sandoz Pharma and/or its
Affiliates in scientific or clinical publications covering Compound or Product.


 


3.7           Sandoz Pharma and Licensee shall meet at
mutually agreed appropriate times at which, the progress of the Licensee’s
development program will be discussed and reviewed. Licensee shall have sole
control over all development activities but Sandoz
Pharma shall be given the opportunity to review and comment on Licensee
development plans, any significant revisions thereof and protocols for the
conduct of clinical studies.


 


4.             Secrecy.


 


4.1           Each
party shall use all reasonable efforts to prevent the disclosure of any
Know-How, Improvements or any information disclosed to it by the other party
under this Agreement without the other party’s prior written consent. Neither
party shall use such information for its own benefit or the benefits of third
parties except for the purpose of performing its rights and obligations under
this Agreement.


 


4.2           This
restriction shall not apply to any information which the disclosing or using
party can prove:


 


(i)            at
the time of use is in the public domain without fault of the disclosing or
using party;


 


4

















 


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)           was
in its or its Affiliates possession at the time of receipt and was not
acquired, directly or indirectly, from the other party;


 


(iii)          was
obtained from a third party without restriction as to use or disclosure,
provided, however, that such information was not obtained by said third party,
directly or indirectly, from the disclosing or using party;


 


(iv)          has
been developed independently of information received from the other party.


 


4.3           Nothing
in this Section 4 shall prevent the disclosure of information (i) to
those proper governmental agencies or others to the extent required by law
and/or (ii) to those permitted sublicensees, consultants and others who have
signed an agreement to keep the information confidential.


 


4.4           The
obligation in this Section 4 shall survive the Agreement for ten (10) years
as and from the effective date of termination or expiration of the entire
Agreement.


 


5.             License
Fees and Other Payments.


 


5.1           In
consideration of the rights and services granted to Licensee by Sandoz Pharma under this Agreement Licensee
shall pay to Sandoz Pharma the following
amounts at the times indicated below:


 


5.1.1        Upon
execution of this Agreement, US $200,000.


 


5.1.2        On
the second anniversary of the date of execution of this Agreement, US $100,000.


 


5.1.3        On
the fifth anniversary of the date of execution of this Agreement, if the NDA is
not approved by the FDA at such time without fault of Sandoz Pharma US $200,000.  “Fault
of Sandoz Pharma” includes, without
limitation, failure of Sandoz Pharma to
timely provide an approvable DMF and chemistry, manufacturing and control
sections for the IND and NDA.


 


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.


 


 


5.1.4        During
the period beginning with the first commercial sale of a Product, a royalty of
[***] during the first year of commercial sale, of [***], during the second
year of commercial sale and of [***] during the period beginning in the third
year of commercial sale and ending five years following NDA-approval shall be
payable to Sandoz Pharma on Net Sales of
Product.


 


5.1.5        After
such five-year period a royalty of [***] shall be payable to Sandoz Pharma on Net Sales of Product for the
term of this Agreement.


 


5.2           All
monies paid by Licensee pursuant to this Agreement are non-refundable and
non-creditable against future royalties.


 


6.             Royalties
and Supply Price.


 


6.1           Licensee
shall furnish to Sandoz Pharma within
ninety (90) days after the end of each calendar quarter in which royalties are
payable hereunder true and accurate reports of its Affiliates and sublicensees
Net Sales and the calculation of royalties payable thereon. Licensee shall
simultaneously pay to Sandoz Pharma a sum
equal to the aggregate of all royalties due for such period. Licensee shall
furnish Sandoz Pharma with copies of all
official receipts for taxes which result in a reduction in royalty payments to Sandoz Pharma and which are directly imposed
and with reference to particular sales of Products. Licensee agrees to
reasonably assist Sandoz Pharma in claiming
refunds for such taxes at Sandoz Pharma’s
request.


 


6.2           Licensee,
its Affiliates and its sublicensees shall pay Sandoz
Pharma Supply Prices (as defined in Section 7.7. below) net sixty
(60) days from date of invoice and on such other reasonable terms and conditions
as Sandoz Pharma ordinarily requires.


 


6.3           Licensee
shall keep accurate records in sufficient detail to enable the royalties
payable hereunder to be determined.  Sandoz Pharma may, at its expense, designate a
suitably qualified independent accountant, reasonably acceptable to Licensee,
to review during ordinary business hours, such part of the records of Licensee
its Affiliates and/or sublicencees as may be necessary to determine, in respect
of any calendar quarter, the accuracy of any report and/or payment made under
this Agreement. This right of review shall terminate three (3) years


 


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.


 


 


after Sandoz Pharma’s receipt of
Licensee’s respective quarterly account.  Said accountant shall not disclose to Sandoz Pharma any information other than that
relating to the accuracy of the reports and payments hereunder.


 


6.4           All
payments, required to be made by Licensee hereunder shall be paid in Swiss Francs
to Sandoz Pharma’s account at Swiss Bank
Corporation, Basle, Switzerland, Attention: Royalty Accountant, or such other
place as Sandoz Pharma may reasonably
designate. The rate of exchange to be used for converting into Swiss Francs
shall be the exchange rate at the same major Swiss Bank on the last business
day of the calendar quarter to which the payment relates.


 


6.5           Payments
due and unpaid under this Agreement shall bear interest from the date payment
is due at an interest rate of eight percent (8%).


 


7.             Good
Faith Efforts and Ordering Procedure.


 


7.1           Should
Licensee fail to comply with its obligations set forth in Section 2.2, Sandoz Pharma’s sole remedy, after ninety (90)
days written notice to Licensee, should Licensee fail to comply with such
obligations, shall be to convert the exclusive license granted according to Section 2.1
into a non-exclusive license.  Licensee
shall entitle Sandoz Pharma, its
Affiliates or any licensee designated by Sandoz
Pharma to get access to the registration of the Product and the
respective documentation including the right to refer to such registration and shall
provide Sandoz Pharma, its Affiliates and
licensees reasonable assistance to enable Sandoz
Pharma, its Affiliates and licensees to sell Product in the Territory.  Such non-exclusive license shall also result
if Licensee engages in marketing, without the prior written consent of Sandoz,
which shall not unreasonably be withheld, a product that materially and
adversely affects the sales and market share of Product.


 


7.2           Quarterly,
Licensee, its Affiliates and its sublicensees shall provide Sandoz Pharma with a written forecast of their
respective estimated Purchase Requirements for each quarter in the ensuing
twenty-four (24) months period beginning three (3) months in advance. Each
first quarter projection in said twenty-four (24) month forecast shall be that
quarter’s Purchase Requirement, a binding commitment on both parties.


 


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.


 


 


7.3           Sandoz Pharma will supply free of charge to
Licensee all requirements of Product and placebo formulations for clinical
trials necessary for FDA registration in dosage form meeting U.S. regulatory
requirements and manufactured at a site meeting U.S. FDA Good Manufacturing
Practice.


 


7.4           Sandoz Pharma will supply and Licensee and its
sublicensees shall purchase all Purchase Requirements in final dosage form meeting
U.S. regulatory requirements and manufactured at a site meeting U.S. FDA and
Canada Good Manufacturing Practice. Notwithstanding the foregoing, Sandoz Pharma shall not be liable to supply
that portion of the Purchase Requirement that exceeds the most recent forecast
of that quarter’s estimated Purchase Requirement by more than thirty percent
(30%).


 


7.5           Sandoz Pharma warrants that it will treat
Licensee in the same manner as it treats Sandoz Affiliates in the supply of
Product and, in addition, Sandoz Pharma
warrants to maintain in reserve a supply of Product exclusively for Licensee in
the Purchase Requirement quantities and dosage form forecast by Licensee, its
Affiliates and sublicensees for the two quarters following the quarter for
which the last supply shipment has been sent. Such reserve shall be maintained
in a location other than a Product manufacturing facility.


 


7.6           Licensee
shall set a reference price (the “Reference Price”) in Swiss Francs not later
than twelve (12) months before the anticipated date of market introduction or March 31,
1994, whichever is earlier, and as Licensee desires from time to time
thereafter, provided, however, that the Reference Price may not be less than
the average of Sandoz Pharma’s ex-factory
prices to wholesalers for equivalent mg-dosages and presentations of Product in
Switzerland, Germany, Denmark and the Netherlands or such other countries as
the parties mutually agree.


 


7.7           Licensee
and its sublicensees shall pay to Sandoz Pharma
a supply price (“Supply Price”) for bulk tablets F.O.B. Basle of:


 


7.7.1        [***]
of the Adjusted Reference Price, which shall be the Reference Price [***] deductable
for the cost items (i)-(iv) listed in paragraph 1.8, of the


 


8

















 


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


 


 


package type having the highest share in turnover for
all Product in normal tablet formulation delivered;


 


7.7.2        [***]
of the Adjusted Reference Price of the package type having the highest share in
turnover for all Product in modified release formulation delivered.


 


8.             Package
and Promotion Material.


 


8.1           Licensee
shall submit to Sandoz Pharma for
approval all labels and package inserts or their equivalent (e.g., Product
descriptions in reference books), incorporating or describing Product and shall
use only such labels and package inserts or their equivalent as are first
approved in writing by Sandoz Pharma. Sandoz Pharma shall not unreasonably withhold
such approval.


 


8.2           All
advertising, promotional literature, labels, package inserts, etc.
incorporating or describing Product shall be sent to Sandoz Pharma which shall have fourteen (14) days following receipt
within which to comment in writing.  If
Licensee does not receive such a comment within fourteen (14) days of Sandoz Pharma’s receipt, Licensee shall be free
to use such written material.  Any
reasonable objection by Sandoz Pharma as
to any item of such written material shall cause the parties to determine a
mutually acceptable way to resolve Sandoz Pharma’s
objection.


 


9.             Liability
and Indemnification.


 


9.1           Licensee
shall indemnify and hold Sandoz Pharma
and its Affiliates harmless from and against any and all liabilities, claims,
damages, losses, costs or expenses (including reasonable attorneys’ fees)
incurred by or rendered against Sandoz Pharma
and its Affiliates which arise out of Licensee’s, its Affiliates’ or
sublicensee’s packaging, testing, use, labeling, storage, handling, sale,
distribution and/or promotion of Product. Such indemnification shall not apply
to the extent that they result from the negligence, gross negligence,
recklessness or willful misconduct of Sandoz
Pharma, its Affiliates, its contractors, its suppliers or its other
licensees.  To the extent such
liabilities, claims, damages, losses, costs or expenses result from the
negligence, gross negligence, recklessness or willful misconduct of Sandoz Pharma, its


 


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.


 


 


Affiliates, its contractors, its suppliers or its other licensees, Sandoz Pharma shall indemnify, protect and hold
harmless Licensee against all such liabilities, claims, damages, losses, costs
or expenses.


 


9.2           Sandoz Pharma shall indemnify and hold Licensee
harmless from and against any and all liabilities, claims, damages, losses,
costs or expenses (including reasonable attorneys’ fees) incurred by or
rendered against Licensee which arise out of Sandoz
Pharma, its affiliates, its contractors, its suppliers or its other
licensee’s design, development, handling, storage, distribution, marketing or
manufacturing Product. Such indemnification shall not apply to the extent that
they result from the negligence, gross negligence, recklessness or willful
misconduct of Licensee, its Affiliates and/or sublicensees.  To the extent such liabilities, claims,
damages, losses, costs or expenses result from the negligence, gross
negligence, recklessness or willful misconduct of Licensee its Affiliates
and/or sublicensees, Licensee shall indemnify, protect and hold harmless Sandoz Pharma against all such liabilities,
claims, damages, losses, costs or expenses.


 


9.3           Sandoz Pharma shall promptly notify Licensee of
any claim or suit brought against Sandoz Pharma
and shall permit Licensee, at Licensee’s cost and expense, to handle and
control such claim or suit. Sandoz Pharma
shall have the right to participate in any defense to the extent that in its
judgment, Sandoz Pharma may be prejudiced
thereby. In any claims or suit in which Sandoz
Pharma seeks indemnification by Licensee, Sandoz Pharma shall not settle, offer to settle or admit liability
or damages in any such claim or suit without the consent of Licensee.


 


9.4           Should
Licensee seek indemnification from Sandoz Pharma,
Section 9.3 shall apply reciprocally.


 


9.5           Licensee
shall provide evidence of insurance coverage sufficient to fulfill Licensee’s
obligations under Section 9.1 provided such insurance is customarily available
at prices which are common for such kind of products in the Territory.


 


9.6           The
obligations in this Section 9 shall survive termination of this Agreement.


 


10

















 


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.


 


 


10.           Force
Majeure.


 


Neither party shall be
responsible to the other for any failure or delay in performing any of its
obligations under this Agreement or for other non-performance hereof provided
that such delay or non-performance is occasioned by a cause beyond the
reasonable control and without fault or negligence of such party, including,
but not limited to fire, flood, explosion, discontinuity in the supply of
power, court order or governmental interference or act of God, and provided
that such party will immediately inform the other party and that it will
entirely perform its obligations immediately after the relevant cause has
ceased its effect.


 


11.           Trademark.


 


11.1         Licensee
shall employ a trademark of its choice in the Territory in connection with the
sale of Product. Licensee shall keep Sandoz
Pharma currently advised of the trademark used by it in connection with
the sale of Product in the Territory.


 


11.2         Licensee
shall not register and/or employ any trademark or trade name which is a
colorable imitation or confusingly similar to a trademark of Sandoz Pharma.


 


12.           Improvements.


 


12.1         Improvements
made by either party and/or its Affiliates or sublicensees under this Agreement
with respect to Product shall be the property of the party making same. Both
parties will cooperate as reasonably necessary to perfect title to such Improvements
in the name of the party entitled to same.  Each party shall promptly disclose to the
other party the general nature of any Improvements made by it its Affiliates
and/or sublicensees along with sufficient detail to enable the other to reach a
decision as to whether it desires to commercially develop same. To the extent Sandoz Pharma is legally free to do, Licensee
shall be automatically, nonexclusively licensed in the Territory to use
pursuant to the terms of this Agreement any Improvements made by Sandoz Pharma hereunder for use only with
products containing Compound. To the extent Licensee is legally free to do, Sandoz Pharma shall be automatically,
non-exclusively licensed free of charge to use and sublicense outside the
Territory or in the Territory pursuant to paragraph 7.1 any Improvements made
by Licensee its Affiliates and/or sublicensees hereunder for use only with
products containing Compound.


 


11

















 


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.


 


 


12.2         After
expiration of this Agreement, either party shall be entitled to continue to use
and/or develop Improvements made by the other party during the term of this
Agreement for use only with products containing Compound. The parties shall
negotiate in good faith appropriate consideration for such further use,
reflecting the investing party’s contribution and the value of such
Improvement.


 


12.3         Sandoz Pharma shall be entitled to terminate
conveyance of Improvements to Licensee should Licensee engage in marketing a
product that materially and adversely affects the sales and market share of
Product.


 


13.           Drug
Monitoring.


 


13.1         Each
party hereto agrees to report promptly to the other party, and to have their
respective Affiliates and sublicensees so report, any information concerning
any serious and/or unexpected side effect, injury, toxicity or sensitivity
reaction or any unexpected incidence or severity thereof associated with
clinical uses, studies, investigations or tests, whether or not determined to
be attributable to Product.  “Serious” as
used in this paragraph refers to experiences which are life threatening,
require hospitalization, prolong existing hospitalization, require prescription
drug therapy or are due to an overdose.  “Unexpected”
as used in this paragraph refers to conditions or developments not previously
submitted to governmental agencies or encountered during clinical studies of
Product, and conditions or developments occurring at a rate higher than shown
by information previously submitted to governmental agencies or encountered
during clinical studies. Upon receipt or any such information by either party
hereto, both parties shall promptly consult each other and use their best
efforts to arrive at a mutually acceptable procedure for taking such possible
actions as appropriate or required under the circumstances; provided, however,
that nothing contained herein shall be construed as restricting the right of
either party to make a report or submission to a governmental agency or to take
any other action that it reasonably deems to be appropriate or required by applicable
law or regulation including the right of Sandoz
Pharma to recall or withdraw Product from marketing and selling in the
Territory.


 


12

















 


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.


 


 


13.2         The
obligation in this Section 13 shall survive termination of this Agreement.


 


14.           Term
and Termination.


 


14.1         This
Agreement shall become effective upon execution. Unless otherwise agreed, this
Agreement will expire on the 10th anniversary of first commercial sale by
Licensee, its Affiliates or sublicensees of a Product licensed by Licensee hereunder.


 


14.2         No
later than one (1) year prior to termination of this Agreement, the
parties shall negotiate in good faith for the terms of a new agreement for the
continued and uninterrupted supply of Product for Licensee and/or its
sublicensees. After expiration of this Agreement, Licensee shall have a paid-up
non-exclusive license to use and sell Product in the Territory and in the event
Sandoz Pharma is unable to supply Product
to make or have made Product in the Territory.


 


14.2.1      Except
as provided in Section 7.1, either party may terminate this Agreement at
its option if the other party should breach any of the material terms of this
Agreement and such breach has not been rectified or at least has begun to be
rectified within sixty (60) days after written notice of such breach by the
other party and thereafter the party in breach has not proceeded diligently to
rectify such breach within a reasonable time, provided however that any such
termination shall not release either party from any obligations hereunder
incurred prior hereto. Licensee’s right to terminate this Agreement shall also
apply should Licensee successfully challenge the confidentiality of the
Know-How of Sandoz Pharma and/or its
Affiliates covered by this Agreement.


 


14.2.2      Should
Licensee become insolvent, make an assignment for the benefit of its creditors
or proceedings in voluntary or involuntary bankruptcy shall be instituted on
behalf of or against Licensee and Licensee fails to aggressively defend such
involuntary bankruptcy proceeding within 90 days or shall Licensee be
dissolved, wound up or be confiscated, sequestered or in any other way be
transferred into state ownership, or if a receiver or trustee of Licensee’s
property shall be appointed, this Agreement shall


 


13

















 


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.


 


 


be subject to immediate termination by Sandoz Pharma upon service of written notice to
such effect upon Licensee.


 


14.3         In
the event this Agreement is terminated, Licensee shall promptly make an
accounting to Sandoz Pharma of the
inventory of the Product it has on hand as of the date of such termination.
Licensee shall have the right to sell its stock of Product for a period of six
months after said termination, it being understood that the Net Sales thereof
shall be subject to the royalty rate as set forth in Section 5, provided,
however, that Sandoz Pharma or a third party
designated by Sandoz Pharma shall have
the right to repurchase the stock of Products at Licensee’s wholesale price.


 


14.4         Upon
termination of this Agreement, all licenses and rights granted hereunder shall
revert to the granting party and all documents containing Know-how shall be
returned to the granting party upon its request.


 


14.5         Upon
termination of this Agreement by Sandoz Pharma,
or Licensee according to Article 14.2.2. Licensee will reassign the
registration of Product to Sandoz Pharma
free of charge and shall return all confidential information and documents
containing Know-how, except that one copy of each document may be retained in
the Licensee’s legal files for record purposes. In addition, Licensee shall
grant to Sandoz Pharma under reasonable
terms to be negotiated which recognize the future value of the promotion and
marketing investment made by Licensee and its sublicensees a license regarding
the trademark used by Licensee for the sale of Product.


 


14.6         Upon
any termination of this Agreement, each provision which is specified to
continue beyond such termination shall continue in force and effect to the
extent necessary to effectuate its purpose.


 


15.           Validity.


 


Should one or
several provisions of the Agreement be or become invalid, then the parties
hereto shall substitute such invalid provisions by valid ones, which in their
economic effect come so close to the invalid provisions that it can be
reasonably assumed that the parties would have


 


14

















 


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.


 


 


contracted this Agreement
with those new provisions. In case such provisions cannot be found, the
invalidity of one or several provisions of the Agreement shall not affect the
validity of the Agreement as a whole, unless the invalid provisions are of such
essential importance for this Agreement that it is to be reasonably assumed
that the parties would not have contracted this Agreement without the invalid
provisions.


 


16.           Applicable
Law.


 


This Agreement
shall be construed in accordance with the substantive laws of New Jersey.


 


17.           Arbitration.


 


17.1         All
disputes arising in connection with the present Agreement shall be settled
under the Rules of Conciliation and Arbitration of the International
Chamber of Commerce, Paris, France (ICC) by three arbitrators appointed in
accordance with the Rules and the decisions of the arbitrators shall
finally bind both parties hereto. Such arbitration shall take place in London,
England, in the English language.


 


17.2         In
any arbitration pursuant to this Agreement, the award or decision shall be
rendered by a majority of the members of the panel provided for herein. The
chairman shall fix a time and place in London, England within thirty (30) days
of his appointment for the purpose of hearing evidence and representations of
the parties and shall preside over the arbitration and determine all questions
of procedure not provided for herein in accordance with the ICC regulations.
After hearing any evidence and representations that each party may submit, the
arbitrators shall make a substantiated award and reduce the same to writing and
deliver one (1) copy thereof to each party within thirty (30) days after
the hearing.


 


17.3         Sections
16 and 17 shall also survive termination of this Agreement.


 


18.           Assignment.


 


This Agreement and
the licenses granted herein shall not be assignable by either party hereto,
except to a successor of all or substantially all of its pharmaceutical
business, without the


 


15

















 


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.


 


 


consent in writing first
obtained from the other party.  Such
non-authorized assignment shall be null and void.  A merger, acquisition or sale of all or
substantially all of the assets of a party to this agreement shall not be
deemed to be an assignment requiring the consent of the other party hereto.


 


19.           Miscellaneous.


 


19.1         Notice.
 Any notice required or permitted to be
given under this Agreement shall be deemed sufficiently given, if sent to the
respective party, by facsimile transmission confirmed by certified or
registered mail or by an internationally recognized overnight delivery service,
to be notified at its address shown at the beginning of this Agreement or at
such other address as may be furnished in writing to the notifying party.  Time of notice or other communication shall be
deemed to be the date of receipt.


 


19.2         Entire
Agreement.  This Agreement contains the
entire understanding of the parties with respect to the subject matter hereof.  No amendment or alteration of this Agreement
shall be valid unless agreed upon by both parties in writing.  The Schedules to this Agreement shall be
considered an integral part thereof.


 


19.3         Waiver.
 The waiver by either party hereto of any
right hereunder or the failure to perform or of a breach by the other party
shall not be deemed a waiver of any other right hereunder or of any other
breach or failure by said other party whether of a similar nature or otherwise.


 


19.4         Obligations.
 Termination of this Agreement shall not
affect obligations accrued prior to termination.


 


19.5         Performance
by Affiliates.  Any party hereto may
satisfy any of its obligations hereunder through any of its Affiliates,
provided, however, that each party guarantees the performance at all times of
any of such party’s obligations so delegated pursuant to this section.


 


16

















 


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.


 


 


IN WITNESS WHEREOF, the
parties hereto have executed this Agreement as of the date first set forth
above.


 


	
  ATHENA NEUROSCIENCES

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Paulette E. Setler

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Executive Vice
  President, Research

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SANDOZ PHARMA LTD.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ R. Wäger

  	
  /s/ R.V. Tschannen

  	
   

  	
   

  
	
   

  	
  Dr. R.
  Wäger

  	
  Dr. R. Tschannen

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Head of Manager
  of Licensing

  	
   

  	
   

  
	
   

  	
  Product Policy

  	
   

  	
   

  
								



 


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.


 


Schedule I


 


to the Agreement by and
between SANDOZ PHARMA and LICENSEE of


 


 


Description of Substance


 


	
  DCI:

  	
   

  	
  Tizanidine -
  hydrochloride

  
	
  Chemical name:

  	
   

  	
  5-chloro-4(2-imidazoline-2yl-amino)-2,
  1, 3-benzo-thiazole hydrochloride

  
	
  Appearance:

  	
   

  	
  white to yellowish
  white finely cristalline powder

  
	
  Loss of drying:

  	
   

  	
  Not more than 0.5 per cent

  
	
  Assay of Tizanidine
  base:

  	
   

  	
  98 - 102 per cent by
  titration

  



 


 


 


	
  Basel,

  	
        April 12,
  1991

  	
   

  	
  South San
  Francisco,

  	
      April 17,
  1991

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  SANDOZ PHARMA LTD.

  	
  ATHENA
  NEUROSCIENCES, INC.

  
	
   

  	
   

  
	
  /s/ R. Wäger-R.V. Tschannen

  	
   

  	
  /s/ Paulette E. Setler

  	
   

  
							



 


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.


 


 


A d d e n
d u m


 


to the License Agreement,
dated April 7th, 1991


 


between


 


Sandoz Pharma
Ltd., a Swiss corporation having its principal place of business at
Lichtstrasse 35, CH-4002 Basel, Switzerland (hereinafter called “Sandoz Pharma”)


 


and


 


Athena Neurosciences, Inc.,
a Delaware corporation having its principal business at 800F Gateway Boulevard,
South San Francisco, California, U.S.A. (hereinafter called “Athena”).


 


The above mentioned
Parties agree to amend Art. 1.11 and Art. 6.2 as follows:


 


1.11.        “Territory” means the United States of America, its
territories and possessions (including Puerto Rico) and Canada, as well as the
United Kingdom and Ireland.


 


6.2.          Athena,
its Affiliates and its sublicensees shall pay Sandoz
Pharma Supply Price (as defined in Section 7.7 of the
above-mentioned Agreement) ninety (90) days from date of invoice and on such
other reasonable terms and conditions as Sandoz
Pharma ordinarily requires. However, for the initial two (2) pre-launch
orders totaling [***], a credit period of one hundred and eighty (180) days
instead of ninety (90) days from data of invoice is granted by Sandoz.


 


	
  Basel,

  	
  South San
  Francisco,

  
	
   

  	
   

  
	
  February 17, 1995

  	
   

  	
  February 24, 1995

  	
   

  
	
  (date)

  	
  (date)

  
	
   

  	
   

  
	
  SANDOZ PHARMA LTD.

  	
  ATHENA
  NEUROSCIENCES, INC.

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ P. Dufner

  	
  /s/ R.V. Tschannen

  	
   

  	
  /s/ Lisabeth F. Murphy

  	
   

  	
   

  
	
  Dr. P.
  Dufner

  	
  Dr. R. Tschanen

  	
   

  	
  Lisabeth F.
  Murphy

  Vice President, Legal Affairs

  and General Counsel

  
						



 


19

















 


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.


 


 


April 12, 1991


 


SANDOZ
PHARMA LTD.

Lichtstr 35

CH-4002 Basel SWITZERLAND


 


Gentlemen:


 


I am happy that we have
now concluded the terms and conditions for Athena to acquire U.S. and Canadian
Marketing rights to tizanidine.


 


As we discussed, there
are a few points that are not practical to fully resolve at this time, and we
agree to negotiate in good faith a final resolution of the following matters
when required for marketing of the product:


 


(1)           Sample
Supply


 


Sandoz agrees to review
Athena’s sample needs to introduce and subsequently market tizanidine.  Sandoz will use its good faith efforts to
supply Athena’s reasonable needs consistent with its own sampling policies.


 


(2)           Final
Form Packaging


 


Sandoz and Athena will
discuss Athena’s needs for final packaging forms and Sandoz agrees use its good
faith efforts to supply these as close to the desired form as possible,
providing Athena is prepared to accept final form packaging materials routinely
used by Sandoz for tizanidine or other similar presentations.


 


(3)           Patent
Review


 


Sandoz and Athena agree
to cooperate to permit Athena and its patent counsel to review any intellectual
property protection that might be available for tizanidine prior to and during
the period of Athena’s marketing of this compound.  Sandoz further agrees to use its good faith
efforts to provide Athena license rights within the terms of the marketing
agreement for any such protection which in Athena’s judgment has commercial
value.


 


Please acknowledge
receipt of this letter by signing the enclosed copy and returning it to me.


 


	
  Yours sincerely,

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/

  	
   

  	
   

  	
   

  
	
  John Groom

  President & Chief Executive Officer

  	
   

  	
  Acknowledged and
  received by:

  SANDOZ PHARMA

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
  /s/

  	
   

  	
   

  	
  /s/

  	
   

  
	
   

  	
  Printed Name:

  	
   

  	
  Dr. S.
  Strub

  	
   

  	
  Dr. R.
  Tschannen

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
  Manager
  Licensing

  	
   

  	
  Manager Licensing

  	
   

  
	
   

  	
  Date:

  	
   

  	
  May 3, 1991

  	
   

  	
  May 3, 1991

  	
   

  
												



 


20