Exhibit
10.1


 


Confidential
Treatment Requested


Under
17 C.F. R. §§ 200.80(b)(4),


200.83
and 240.24b-2


 


LICENSE AGREEMENT


 


THIS LICENSE AGREEMENT (“License Agreement”)  is entered into and
made on March 1st, 2004 (the “Effective Date”) by and between:
(a) on the one hand, SHIRE BIOCHEM INC. (“SBI”), a corporation organized and existing
under the laws of Canada and wholly-owned subsidiary of Shire, having its
principal office at 275 Armand-Frappier Boulevard, Laval, Quebec, Canada
H7V 4A7; and (b) on the other hand, MAXIM PHARMACEUTICALS, INC. (“Maxim”), a
corporation incorporated and existing under the laws of the State of Delaware,
having its principal office at 8899 University Center Lane, Suite 400, San
Diego, California 92122, U.S.A, and CYTOVIA,
INC. (“Cytovia”),
a corporation incorporated and existing under the laws of the State of Delaware
and a wholly-owned subsidiary of Maxim, having the same principal office as
Maxim (Maxim and Cytovia are hereinafter collectively referred to as “MPI”).  SBI and MPI are hereinafter collectively
referred to as “Parties”
or individually as a “Party.”


 


RECITALS


 


WHEREAS
on July 10th, 2000 SBI (formerly BioChem Pharma Inc.) and Cytovia entered into
a Research and License Agreement under which the Parties agreed to pursue research
in order to design and characterize candidates for the purpose of then enabling
SBI to develop such products (hereinafter the “Agreement”);


 


WHEREAS
pursuant to said Agreement, Cytovia granted SBI an exclusive license to
research, develop and commercially exploit Cytovia’s intellectual property
relating to the Products, as more fully defined in the Agreement;


 


WHEREAS
on June 17th, 2002, SBI formally advised MPI of its intention not to renew the
Research Term of the Agreement;


 


WHEREAS
the Parties have now further agreed to terminate all remaining rights and
obligations under the Agreement and SBI, in furtherance thereof, has also
agreed to assign and/or license to MPI rights it may own or share in the
intellectual property conceived under the Research Program (as then defined in
the Agreement) as more fully detailed herein;


 


NOW, THEREFORE, in consideration of the
mutual covenants contained herein, and for other good and valuable
consideration, the amount and sufficiency of which are hereby acknowledged, the
Parties hereby agree as follows:


 


ARTICLE 1




DEFINITIONS


 


1.1          “Affiliate” means at the
time of determination (i) any Person which is directly or indirectly
controlled by any Party hereto; (ii) any Person which directly or
indirectly controls any


 


1

















 


Party hereto; or (iii) any Person which is under
the direct or indirect control of any such Person as described in (i) or
(ii).  “Control” shall in this context mean
ownership of greater than fifty percent (50%) of the voting stock or other
voting interests in the Person in question. 
In any country of the Territory in which local law prohibits the
ownership by MPI or SBI of greater than fifty percent (50%) of the voting stock
or other voting interests of an entity, the entity shall be deemed an Affiliate
if MPI or SBI owns the maximum percentage permitted by law, as long as such
maximum percentage is at least thirty percent (30%).


 


1.2          “Agency” means any
governmental regulatory authority responsible for granting Regulatory Approvals
for the sale of Product.


 


1.3          “Control” or “Controlled” in the
context of intellectual property rights means rights to intellectual property
sufficient to grant the applicable license or sublicense under this License
Agreement, without violating the terms of any agreement or other arrangement
with any Third Party, provided that where a license or sublicense under this
License Agreement shall be exclusive, if the granting Party does not have the
right under a Third Party agreement entered into prior to the Effective Date to
grant an exclusive license or sublicense, such license or sublicense shall be
non-exclusive.


 


1.4          “Effective Date” has the
meaning set forth in the first paragraph of this License Agreement.


 


1.5          “FDA” shall mean the
United States Food and Drug Administration, or any successor thereto.


 


1.6          “Field” means the
treatment of human diseases.


 


1.7          “GCP” means “Good Clinical Practices”
as defined under applicable FDA rules and regulations and Guideline E-6 of the
International Council of Harmonization.


 


1.8          “IND” means an
“Investigational New Drug” application, as defined in the United States Food,
Drug and Cosmetic Act, as amended, and applicable FDA rules and regulations or
non-U.S. equivalent thereof in a Major Country.


 


1.9          “Initiation of Phase II Clinical Trials”
means dosing of the first patient at the first site of Phase II Clinical
Trials.


 


1.10        “Initiation of Phase III Clinical Trials”
means dosing of the first patient at the first site of Phase III Clinical
Trials.


 


1.11        “Joint Patent Rights”
shall mean those Patents claiming inventions made jointly by one (1) or more
employees or consultants of each Party or otherwise listed on Exhibit A
hereto.  Joint Patent Rights as they
exist as of the Effective Date are set forth on Exhibit A hereto.


 


1.12        “Launch” means the date
of first commercial shipment of the Product by MPI, its Affiliates,
distributors or sublicensees to Third Party customers in each respective
country of the 


 


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Territory
after the receipt of Regulatory Approval for the Product from the relevant
Agency, as may be necessary in such country.


 


1.13        “Loss” has the meaning
set forth in Section 7.1.


 


1.14        “Major Countries” means
the following countries of the Territory: 
[***].


 


1.15        “MPI Know-How” means all
proprietary Technical Information owned or Controlled by MPI as of the
Effective Date or during the term of this License Agreement and that relates
to, or is necessary or useful for the design, synthesis, identification,
research, development, manufacture, use or sale of Products.


 


1.16        “MPI Patent Rights”
means all Patents in any country within the Territory which are owned or
Controlled by MPI as of the Effective Date or during the term of this License Agreement
that relate to, or are necessary or useful for the design, synthesis,
identification, research, development, manufacture, use or sale of Products,
including those Patents which claim a Product, formulation, process of
manufacture, or method of use of such Product. 
MPI Patent Rights as they exist as of the Effective Date are set forth
on Exhibit B
hereto.


 


1.17        “NDA” means a “New Drug
Application,” as defined in the United States Food, Drug and Cosmetic Act, as
amended, and applicable FDA rules and regulations, or any non-U.S. equivalent
thereof.


 


1.18        “Net Sales” means the
total gross sales (number of units shipped times the invoiced price per unit)
to Third Parties representing sales invoiced by MPI and its Affiliates (but not
Sublicensees) of the Product in the Territory, less deductions for the
following to the extent actually paid or allowed:


 


(a)           sales and excise
taxes and duties (including import duties) paid or allowed by a selling party
and any other governmental charges imposed upon the manufacture or sale of the
Product;


 


(b)           normal and
customary trade, quantity and cash discounts (up to the amount normal and
customary in the country of the Territory for early payment of invoices) and
rebates, chargebacks and administrative fees (including rebates to social and
welfare systems);


 


(c)           allowances,
chargebacks and credits to Third Parties on account of rejected, damaged,
outdated, returned, withdrawn or recalled Product or on account of retroactive
price reductions affecting the Product;


 


(d)           amounts due to
Third Parties on account of rebate payments, including Medicaid rebates; and


 


(e)           transport, freight,
insurance, handling and distribution transportation charges and insurance
through the whole distribution pipeline (e.g., from MPI through to the Third
Party customer).


 












***Confidential
Treatment Requested


 


3

















 


In
addition, MPI shall be entitled to deduct from Net Sales any receivables which
are deemed to be uncollectible according to MPI’s internal accounting
principles and generally accepted accounting principles consistently
applied.  Such bad debt deduction shall
be applied to Net Sales in the period in which such receivables are written off
and shall be exclusive of any bad debt or uncollectible receivables of MPI or
its Affiliates unrelated to the Products.


 


Sales between MPI and its Affiliates shall be excluded
from the computation of Net Sales, but Net Sales shall include the first sales
to Third Parties by any such Affiliates. 
The supply of Product as commercial samples (in quantities customary
within the pharmaceutical industry) or for use in clinical studies shall not be
included within the computation of Net Sales. 
Where (i) the consideration for the Product shall include any
non-cash element; or (ii) the Product shall be transferred by MPI or an
Affiliate in any manner other than an invoiced sale, the Net Sales applicable
to any such transaction shall be deemed to be MPI’s average Net Sales for the
applicable quantity of Product at that time.


 


If a Product is sold or
provided as part of a system, package, or combination product or service that
contains one or more other active ingredients or other parts that could be sold
separately (each, a “Combination Product” and collectively, “Combination
Products”), Net Sales shall be calculated by multiplying the Net Sales received
by MPI or an Affiliate from the sale of Combination Products by the fraction
A/B, where “A” is the fair market value of the Product when supplied or priced
separately and “B” is the fair market value of the Combination Product.  In the event that no market price is
available for the Product when supplied or priced separately, fair market value
shall be determined in good faith by MPI and SBI.  In the event that SBI and MPI disagree regarding determination of
fair market value, the Parties agree to submit such disagreement to arbitration
in accordance with Section 14.5.


 


1.19        “Patent” (which term may
be used either in the singular or plural form) means any patent and patent
applications, and all additions, divisions, continuations, continuations
in-part, pipeline protection, substitutions, reissues, extensions,
registrations, patent term extensions, supplementary protection certificates
and renewals of any of the above.


 


1.20        “Person” shall include a
corporation, partnership or other entity.


 


1.21        “Phase I Clinical Trials”
means “Phase 1” investigational studies as defined within 21 CFR 312.21
and other applicable regulations promulgated by the U.S. Department of Health
and Human Services or FDA or non-U.S. equivalent thereof.


 


1.22        “Phase II Clinical Trials”
means “Phase 2” investigational studies as defined within 21 CFR 312.21
and other applicable regulations promulgated by the U.S. Department of Health
and Human Services or FDA or non-U.S. equivalent thereof.


 


1.23        “Phase III Clinical Trials”
means “Phase 3” investigational studies as defined within 21 CFR 312.21
and other applicable regulations promulgated by the U.S. Department of Health
and Human Services or FDA or non-U.S. equivalent thereof.


 


1.24        “Product” means any
member of the class of substituted 4-H chromenes, analogs and derivatives
thereof as described
in Exhibit C
hereto and any compound encompassed by the 


 


4

















 


generic chemical formulae included in
those Joint Patent Rights specifically set forth in Exhibit A,
including all formulations and modes of administration thereof.


 


1.25        “Regulatory Approval”
means the product license or marketing approval necessary as a prerequisite for
marketing a Product in a particular country in the Territory, including any
approval for price or reimbursement (hereinafter, “pricing approval”) as may be
necessary or appropriate in such country.


 


1.26        “SBI Know-How” means all
proprietary Technical Information owned or Controlled by SBI as of the
Effective Date and that relates
to, or is necessary or useful for the design, synthesis, identification,
research, development, manufacture, use or sale of the Products as more fully
appears from Exhibit D
attached hereto.


 


1.27        “SBI Patent Rights”
means all Patents in any country within the Territory which are owned or
Controlled by SBI as of the Effective Date or during the term of this License
Agreement that claim the manufacture, use or sale of a Product (including,
without limitation, any formulation, process of manufacture, or method of use
of such Product).  SBI Patent Rights as
they exist as of the Effective Date are set forth on Exhibit E
hereto.


 


1.28        “Sublicensee” shall mean
a Third Party to whom MPI has granted rights pursuant to Section 2.1.1 beyond the mere right to
purchase Product from MPI or its Affiliates.


 


1.29        “Sublicensing Fees”  shall mean the amount actually paid
to MPI or an Affiliate of MPI by a Sublicensee arising from the sublicense of
the right to research, develop, make, have made, use, distribute for sale,
promote, market, offer for sale, sell, have sold, import or export Products
(each, a “Sublicense”).  Sublicensing Fees shall include up-front or
license fees, milestone payments, royalties payable to MPI or its Affiliates by
a Sublicensee based on such Sublicensee’s sale of Products, premiums above
market price on sales of securities and any other payments in respect of a
Sublicense but shall not include any payments tied directly to the provision of
goods and services incurred and expensed at fair market value for such goods
and services by MPI or its Affiliate to such Sublicensee (including research
and development and manufacturing) to compensate MPI or its Affiliate for the
provision of such goods and services, or payments for securities (other than
premiums above market price).


 


1.30        “Technical Information”
means all techniques and data and other know-how and technical information
including inventions (whether or not patentable), improvements and
developments, practices, methods, concepts, know-how, trade secrets, documents,
computer data, source code, apparatus, clinical and regulatory strategies, test
data, analytical and quality control data, manufacturing, patent data or
descriptions, development information, drawings, specifications, designs,
plans, proposals and technical data and manuals and all other proprietary
information related to the Product.


 


1.31        “Territory” means all
the countries of the world.


 


1.32        “Third Party” means any
Person other than a Party to this License Agreement or an Affiliate.


 


5

















 


1.33        “Valid Patent Claim”
means a claim of an issued and unexpired
Patent or a claim of a pending patent application within the MPI Patent
Rights, SBI Patent Rights or Joint Patent Rights, which claim has not lapsed,
been canceled, become abandoned, or been revoked or declared invalid or
unenforceable by an unreversed and unappealable decision or judgment of a court
or other governmental agency of competent jurisdiction, and which has not been
admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise.  For the purposes of this
License Agreement, a claim of a pending patent application shall only be deemed
a Valid Patent Claim for a period of five (5) years from the date of first
publication of such application in those countries where applications are
published or, in those countries where applications are not published, for a
period of five (5) years from filing of such application.  If a claim of a pending patent application
does not mature into an issued patent within the aforementioned five (5) year
period of time, such a claim will no longer qualify as a Valid Patent Claim.


 


ARTICLE 2



LICENSE
GRANTS


 


2.1          SBI
License Grant.


 


2.1.1       Subject to the terms
and conditions of this License Agreement, during the term of this License
Agreement, SBI hereby grants to MPI an exclusive, worldwide, royalty-bearing
license, including the right to grant sublicenses (which themselves may include
the right to grant further sublicenses), under the SBI Patent Rights, the SBI
Know-How and SBI’s interest in the Joint Patents, to research, develop, make
and have made, use, distribute for sale, promote, market, offer for sale, sell,
have sold, import and export Products in the Field.


 


2.1.2       The term “exclusive” as
used in Section 2.1.1 shall operate to exclude all others, including SBI
and its Affiliates, from the rights conferred by SBI pursuant to
Section 2.1.1.  SBI shall not,
during the term of this License Agreement, either itself or through any
Affiliate, conduct any research, development or commercialization activities
with respect to any Product or enter into any agreement with any Third Party
with respect to research, development or commercialization of any Product.


 


2.1.3       All rights and licenses
granted by MPI to SBI under MPI Patent Rights and MPI Know-How pursuant to the
Agreement are hereby terminated and shall revert to MPI as of the Effective
Date.


 


2.2          Transfer
of SBI Know-How.


 


2.2.1       Concurrent with the
execution of the License Agreement, SBI shall use commercially reasonable
efforts to transfer to MPI the SBI Know-How related to the Product which will
include, without limitation, Structure Activity Relationship (SAR) data and
medicinal chemistry of the Product and the additional items listed on Exhibit E
hereto.


 


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ARTICLE 3



TERM


 


3.1          Term. 
The term of this License Agreement shall commence on
the Effective Date and unless sooner terminated by mutual agreement or pursuant
to any other provision of this License Agreement shall expire, on a
country-by-country basis upon the later of (i) expiration of the last to expire
of the Valid Patent Claims covering the manufacture, use or sale of each
Product in a particular country on a Product-by-Product basis or (ii) ten (10)
years from Launch of the first Product in a particular country.


 


ARTICLE 4



REGULATORY
ACTIVITIES, APPROVALS, and COMPLIANCE


 


4.1          Regulatory Activities and Approvals.


 


4.1.1       MPI shall be
responsible for, either itself or through its designee, and fund all
pre-clinical and non-clinical work, all clinical trials and all other
regulatory matters relating to the Products, including all communications with
the relevant Agencies with respect to the Products in the Territory.  MPI shall be responsible for the
preparation, filing and prosecution of all INDs, as well as all other Agency
filings for obtaining and maintaining Regulatory Approvals in the
Territory.  MPI shall own all such
filings and Regulatory Approvals during and after the term of this License
Agreement.


 


4.1.2       MPI shall use
commercially reasonable efforts to develop a Product or Products, obtain or
have obtained Regulatory Approvals of such Product or Products in one or more
of the Major Countries and, following said Regulatory Approval, market and sell
or have marketed and sold such Product or Products in any Major Countries.  In furtherance of the above, MPI shall
provide SBI on an annual basis with a reasonably detailed progress report
outlining MPI’s efforts to develop a Product or Products, progress in obtaining
Regulatory Approvals of such Products in any Major Countries.  Failure by MPI to provide SBI with the
aforesaid progress report shall constitute a breach under this License
Agreement.


 


ARTICLE 5



LICENSE
PAYMENTS, CLINICAL TRIAL

AND REGULATORY APPROVAL MILESTONES; ROYALTIES AND REPORTS


 


5.1          Clinical Trial, Regulatory Approval
and Commercialization Milestone Payments.  MPI shall make payments to SBI in U.S.
dollars as set forth within the table below within thirty (30) days after the
achievement of each of the respective clinical trial, regulatory approval, and
commercialization milestones by MPI or its Affiliate in a Major Market where
MPI has not granted development or commercialization rights with respect to
Products to any Sublicensee, provided that, (i) [***] shall [***] be payable under this Section 5.1 (i.e., the maximum amount that may be
payable pursuant to this Section 5.1 is [***]),
notwithstanding the 


 












***Confidential
Treatment Requested


 


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total number of Products developed or indications
pursued or approved or the number of Major Markets in which any Product is developed
or approved; and (ii) in the event that a Product shall be discontinued
after any milestone shall have been paid, such milestone shall be credited
against the milestone due for any Product subsequently pursued.  In the event that a subsequent milestone
shall be triggered where a prior milestone has not been triggered (for example,
Phase III trials shall be initiated without prior initiation of Phase II
trials), then both milestones shall be payable upon the happening of the
subsequent milestone.  For purposes of
clarification, if any of the milestones set forth in this Section 5.1 is
achieved by a Sublicensee, no milestone payment shall be due under this
Section 5.1 with respect thereto.


 


	
  MILESTONE

  	
   

  	
  PAYMENT

  
	
  1.   First dosing of a human subject with a Product in a Major Market

  	
   

  	
  [***]

  
	
  2.   Initiation of a Phase II Clinical Trial of a Product in a Major
  Market

  	
   

  	
  [***]

  
	
  3.   Initiation of a Phase III Clinical Trial of a Product in a Major
  Market

  	
   

  	
  [***]

  
	
  4.   Fist NDA filing for a Product in a Major Market

  	
   

  	
  [***]

  
	
  5.   First commercial sale of a Product in a Major Market

  	
   

  	
  [***]

  



 


5.2          Royalties.  In all countries of the Territory in which
there exists a Valid Patent Claim that would, but for the license granted
hereunder or under the Agreement, be infringed by the manufacture, use or sale
of the Product as commercialized by MPI or its Affiliate (so long as any claim
covering manufacture excludes others from selling the Product as commercialized
by MPI or its Affiliate in the country in question), MPI shall pay to SBI (subject
to the remaining terms and conditions of this Section 5.2) following Launch a royalty
of [***] of
Net Sales of the Product by MPI and its Affiliates (but not by Sublicensees)
for so long as such a Valid Patent Claim shall exist in such country.  In all other countries, MPI shall pay to SBI
a royalty of [***]
of Net Sales of the Product by MPI and its Affiliates (but not by
Sublicensees), for a maximum of ten (10) years following Launch.  In addition, such [***] royalty shall also apply with respect
to a Product for the remainder of such ten (10) year period in any country
where such a Valid Patent Claim covering manufacture, use or sale of such
Product as commercialized by MPI or its Affiliate has expired prior to such ten
(10) year period.


 


5.2.1       However, if the Valid
Patent Claim arises from a pending patent application, then payments at the [***] royalty
level shall only be required for a period of five (5) years from first
publication, or, in those countries where governmental agencies do not 


 












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Treatment Requested


 


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publish patent applications, for a period of five (5)
years from filing.  In the event that
the said patent application does not mature into an issued patent within this
five (5) year period of time, such a patent claim will no longer be deemed a
Valid Patent Claim and SBI shall refund (or in lieu of such refund, MPI may set
off such amount against any payments owed by MPI to SBI) one-half of any
corresponding payments made at the [***] royalty rate so as to yield the rate
of [***] of
Net Sales of Product set forth above for countries where there is no Valid
Patent Claim.  In the event that SBI
opts for a set-off rather than an immediate refund of amounts owed to MPI, the
amount owed shall accrue interest from the date due, and thus the set-off shall
also include such interest to be computed for such unpaid amount on the last
day of each calendar quarter (accruing quarterly) at the prime or other
equivalent rate of Citibank for the last day of the calendar quarter, or the
highest interest rate permissible under applicable law, whichever is
lower.  In the event that a Valid Patent
Claim covering the Product as commercialized by MPI or its Affiliate shall
issue in a country where royalty was paid at the [***] level as a result of pendency of a
patent application for more than five (5) years as provided herein, then MPI
shall pay to SBI (taking into account any refunds made by SBI) the difference
between the royalty payable at the [***] level and that paid at the [***] level for
the period of the reduced royalty payments until issue of the Patent, together
with interest on such amount at the prime or other equivalent rate of Citibank
on the last day of each calendar quarter, or the highest interest rate
permissible under applicable law, whichever is lower, until payment of such
amount by MPI.


 


5.3          Sublicenses.  In the event that MPI or any of its
Affiliates sublicenses to a Sublicensee its rights under the licenses granted
by SBI, MPI shall pay SBI [***] of all Sublicensing Fees received by MPI or
its Affiliate from such Sublicensee.


 


5.4          Payments and Royalty Report.  Payments due to SBI pursuant to Sections 5.2 and 5.3
shall be paid within forty five (45) days following the end of each calendar
quarter in which MPI or any of its Affiliate makes Net Sales or receives
Sublicensing Fees.  All such payments
shall be accompanied by a report which sets forth for the preceding calendar
quarter the following information:


 


(a)           total Net Sales of
Products sold in the Territory during such period;


 


(b)           deductions
applicable to determining the Net Sales;


 


(c)           the exchange
rate(s) used to determine amounts owing hereunder;


 


(d)           the amount of
royalties due pursuant to Section 5.2; and


 


(e)           Sublicensing Fees.


 


If no payments are due to
SBI for any reporting period following Launch, the written report shall so
state.


 


5.5          Currency of Payment.  All payments to be made under this License
Agreement shall be made in U.S. dollars. 
Net Sales outside the United States shall be first determined in the
currency in which they are earned and shall then be converted into an amount in
U.S. dollars 


 












***Confidential
Treatment Requested


 


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using the noon buying rate as published in the Wall Street
Journal for the last day of the calendar quarter for which such
payment is being determined.


 


5.6          MPI Accounting Obligations and SBI
Audit Rights.  MPI
shall keep accurate records for a period of at least five (5) years (or such
longer period as may correspond to MPI’s internal records retention policy) for
each reporting period during the term of this License Agreement and in which
sales of Products occur showing sales of Products in sufficient detail to
enable the reports provided under Section 5.4 to be verified.  SBI shall have the right, for a period of
three (3) years after receiving any report or statement with respect to Net
Sales to appoint an independent certified public accountant to inspect the relevant
records of MPI to verify such report or statement.  MPI shall make its records available for inspection by such
independent certified public accountant during regular business hours at such
place or places where such records are customarily kept, upon reasonable
notice, solely to verify the accuracy of the reports and payments.  Such inspection right shall not be exercised
more than once in any calendar year. 
Any examination by an independent accounting firm under this
Section is to be made at the expense of SBI, except that if the results of
the audit reveal that MPI has underpaid SBI by ten percent (10%) or more in any
calendar year, then the audit fees shall be paid by MPI.  Any such discrepancies shall be promptly corrected
by payment by MPI to SBI.  The accounting
firm shall execute a confidentiality agreement reasonably acceptable to MPI
prior to any such audit limiting the information to be provided to SBI to the
numerical summary of royalties due and paid and prohibiting any disclosure to
Third Parties.


 


5.7          Late Payments.  In the event that any payment, including,
without limitation, royalty and milestone payments and payments with respect to
Sublicensing Fees, due hereunder is not made when due, the payment shall accrue
interest from the date due, which interest shall be computed for such unpaid
amounts on the last day of each calendar quarter (accruing quarterly) at the
prime or other equivalent rate of Citibank for the last day of the calendar
quarter plus [***]
or the highest interest rate permissible under applicable law, whichever is
lower.  The payment of such interest
shall not limit SBI from exercising any other rights it may have as a
consequence of the lateness of any payment.


 


5.8          Exchange Control.  If at any time legal restrictions prevent
the prompt remittance of part or all of royalties owed by MPI to SBI hereunder
with respect to any country in the world where the Product is sold, payment
shall be made through any lawful means or methods that may be available as MPI
shall reasonably determine.


 


5.9          Withholding Taxes.  MPI or its Affiliates shall be entitled to
deduct from its payments to SBI the amount of any withholding taxes required to
be withheld by MPI or its Affiliates to the extent MPI or its Affiliates pay to
the appropriate governmental authority on behalf of SBI such taxes.  MPI shall deliver to SBI, upon SBI’s
request, proof of payment of all such taxes and the appropriate documentation
which is necessary to obtain a tax credit, to the extent such tax credit can be
obtained.  Each Party shall provide
assistance to the other Party in seeking any benefits available to such Party
with respect to government tax withholdings by any relevant law or double tax
treaty.


 


5.10        Discontinued
Product.  In the event
that MPI shall in its discretion, discontinue development of a Product that has
been designated a candidate drug by MPI, then upon request


 












***Confidential
Treatment Requested


 


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by SBI, and provided that such discontinued Product is not similar to
or otherwise competitive with a Product still under development by MPI, the
Parties shall negotiate in good faith terms for the return of rights in such
Product to SBI, which shall include provision to SBI of data relating to such
Product developed by MPI.


 


ARTICLE 6



REPRESENTATIONS
AND WARRANTIES


 


6.1          SBI’s Representations and Warranties.  SBI hereby represents and warrants the
following to MPI:


 


6.1.1       SBI (i) is a
corporation duly organized, validly existing, and in good standing under the
laws of Canada, with its principal place of business as indicated in the first
paragraph of this License Agreement; (ii) is duly qualified as a
corporation and in good standing under the laws of each jurisdiction where its
ownership or lease of property or the conduct of its business requires such
qualification, where the failure to be so qualified would have a material
adverse effect on the financial condition of SBI or the ability of SBI to
perform its obligations hereunder; (iii) has the requisite corporate power
and authority and the legal right to conduct its business as now conducted;
(iv) has all necessary licenses, permits, consents, or approvals from or
by, and has made all necessary notices to, all governmental authorities having
jurisdiction, to the extent required for such ownership and operation; and
(v) is in compliance with its certificate of incorporation and bylaws.


 


6.1.2       The execution, delivery
and performance of this License Agreement by SBI and all instruments and
documents to be delivered by SBI hereunder: (i) are within the corporate
power of SBI; (ii) have been duly authorized by all necessary or proper
corporate action; (iii) are not in contravention of any provision of the
certificate of incorporation or bylaws of SBI; (iv) will not violate the
terms of any indenture, mortgage, deed of trust, lease, agreement, or other
instrument to which SBI is a party or by which SBI or any of its property is
bound, which violation would have a material adverse effect on the financial
condition of SBI or on the ability of SBI to perform its obligations hereunder;
and (v) do not require any filing or registration with or the consent or
approval of, any governmental body, agency, authority or any other person.


 


6.1.3       This License Agreement
has been duly executed and delivered by SBI and constitutes a legal, valid and
binding obligation of SBI, enforceable against SBI in accordance with its
terms, except as such enforceability may be limited by applicable insolvency
and other laws affecting creditors’ rights generally or by the availability of
equitable remedies.


 


6.1.4       SBI follows reasonable
commercial practices common in the industry to protect its proprietary and
confidential information, including requiring its employees, consultants and
agents to be bound in writing by obligations of confidentiality and
non-disclosure and requiring its employees, consultants and agents to assign to
it any and all inventions and discoveries discovered by such employees,
consultants and/or agents made within the scope of, and during their
employment, and only disclosing proprietary and confidential


 


11

















 


information to the Third Parties pursuant to written
confidentiality and non-disclosure agreements.


 


6.1.5       SBI has not previously assigned, transferred, conveyed, licensed or
otherwise granted a Third Party any right, title or interest in its rights in
the MPI Patent Rights, MPI Know-How, Joint Patent Rights, SBI Patent Rights or
SBI Know-How.


 


6.1.6       SBI has not received written notice from any Third Party alleging that
the practice of the MPI Patent Rights, MPI Know-How, Joint Patent Rights, SBI
Patent Rights or SBI Know-How infringes or may infringe any intellectual
property rights owned or possessed by such Third Party.


 


6.1.7       There are no claims, judgments or settlements against or owed by SBI, or
claims or litigation against SBI pending or threatened in writing, relating to
SBI’s ownership of Joint Patent Rights, SBI Patent Rights or SBI Know-How.


 


6.1.8       SBI has provided MPI with a true and complete list of the Joint Patent
Rights and SBI Patent Rights existing as of the Effective Date.


 


6.2          MPI’s Representations and Warranties.  MPI hereby represents and warrants the
following to SBI:


 


6.2.1       MPI (i) is a
corporation duly organized, validly existing, and in good standing under the
laws of the State of Delaware, with its principal place of business as
indicated in the first paragraph of this License Agreement; (ii) is duly
qualified as a corporation and in good standing under the laws of each
jurisdiction where its ownership or lease of property or the conduct of its
business requires such qualification, where the failure to be so qualified
would have a material adverse effect on the financial condition of MPI or the
ability of MPI to perform its obligations hereunder; (iii) has the
requisite corporate power and authority and the legal right to conduct its
business as now conducted; (iv) has all necessary licenses, permits,
consents, or approvals from or by, and has made all necessary notices to, all
governmental authorities having jurisdiction, to the extent required for such
ownership and operation; and (v) is in compliance with its certificate of
incorporation and bylaws.


 


6.2.2       The execution, delivery
and performance of this License Agreement by MPI and all instruments and
documents to be delivered by MPI hereunder: (i) are within the corporate
power of MPI; (ii) have been duly authorized by all necessary or proper
corporate action; (iii) are not in contravention of any provision of the
certificate of incorporation or bylaws of MPI; (iv) will not violate the
terms of any indenture, mortgage, deed of trust, lease, agreement, or other
instrument to which MPI is a party or by which MPI or any of its property is
bound, which violation would have a material adverse effect on the financial
condition of MPI or on the ability of MPI to perform its obligations hereunder;
and (v) do not require any filing or registration with or the consent or
approval of, any governmental body, agency, authority or any other person.


 


6.2.3       This License Agreement
has been duly executed and delivered by MPI and constitutes a legal, valid and
binding obligation of MPI, enforceable against MPI in 


 


12

















 


accordance with its terms, except as such
enforceability may be limited by applicable insolvency and other laws affecting
creditors’ rights generally or by the availability of equitable remedies.


 


6.2.4       MPI follows reasonable
commercial practices common in the industry to protect its proprietary and
confidential information, including requiring its employees, consultants and
agents to be bound in writing by obligations of confidentiality and
non-disclosure and requiring its employees, consultants and agents to assign to
it any and all inventions and discoveries discovered by such employees,
consultants and/or agents made within the scope of, and during their
employment, and only disclosing proprietary and confidential information to the
Third Parties pursuant to written confidentiality and non-disclosure
agreements.


 


6.2.5       MPI has not previously assigned, transferred, conveyed, licensed or
otherwise granted a Third Party any right, title or interest in its rights in
the MPI Patent Rights, MPI Know-How, Joint Patent Rights, SBI Patent Rights or
SBI Know-How.


 


6.2.6       MPI has not received written notice from any Third Party alleging that
the practice of the MPI Patent Rights, MPI Know-How, Joint Patent Rights, SBI
Patent Rights or SBI Know-How infringes or may infringe any intellectual
property rights owned or possessed by such Third Party.


 


6.2.7       There are no claims, judgments or settlements against or owed by MPI, or
claims or litigation against MPI pending or threatened in writing, relating to
MPI’s ownership of Joint Patent Rights, MPI Patent Rights or MPI Know-How.


 


6.2.8       MPI has provided SBI with a true and complete list of the MPI Patent
Rights existing as of the Effective Date.


 


ARTICLE 7



INDEMNIFICATION


 


7.1          Indemnification.  Each Party (the “Indemnifying Party”) agrees
to indemnify and hold forever harmless the other Party and its Affiliates and
each of their agents, directors, officers and employees from and against any
loss, damage, action, proceeding, cost, expense or liability (including
reasonable attorneys’ fees) (collectively, “Loss”) arising from or in
connection with: the breach or inaccuracy of any representations or warranties
made by the Indemnifying Party in this License Agreement.


 


7.2          Third Party Product Liability Claims.  MPI agrees to indemnify and hold forever
harmless SBI and its Affiliates and each of their agents, directors, officers
and employees from and against any Loss arising from or in connection with
Third Party product liability claims related to the development, manufacture,
packaging, labeling, handling, storage, transportation, use, distribution,
promotion, marketing and sale of any product by MPI or any of its Affiliates,
distributors, sublicensees or agents.


 


13

















 


7.3          Procedure.  The indemnities set forth in this Article 7 are
subject to the condition that the Party seeking indemnity shall forthwith
notify the Indemnifying Party on being notified or otherwise made aware of a
suit, action or claim and that the Indemnifying Party defend and control any
proceedings with the other Party being permitted to participate at its own
expense (unless there shall be a conflict of interest which would prevent
representation by joint counsel, in which event the Indemnifying Party shall
pay for the other Party’s counsel); provided that the Indemnifying Party may
not settle the suit or otherwise consent to any judgment in such suit without
the written consent of the Indemnified Party (such consent not to be
unreasonably withheld).  The Parties shall
cooperate in the defense of any Third Party claim.


 


7.4          Payment.  Without in any way limiting SBI’s
indemnification obligations pursuant to this Article 7 or any other remedies MPI may
have, if SBI shall not fully compensate MPI as required pursuant to its indemnification
obligations under this Article 7,
until such time as SBI shall do so, MPI shall have the right to credit the
remaining balance owed to MPI against the royalties and other payments payable
to SBI under this License Agreement, and if this License Agreement terminates
or expires prior to SBI fully compensating MPI or SBI is no longer receiving
royalties or other payments under this License Agreement, such remaining
balances owed to MPI pursuant to this Article 7 shall continue to be due and
payable in full.  Without in any way
limiting either Party’s indemnification obligations pursuant to this Article 7 or any
other remedies a Party may have, if the other Party shall not fully compensate
the other Party as required pursuant to its indemnification obligations
pursuant to this Article 7,
the Party shall pay the other Party interest to be computed for such unpaid
amount on the last day of each calendar quarter (accruing quarterly) at the
prime or other equivalent rate of Citibank for the last day of the calendar
quarter plus [***]
or the highest interest rate permissible under applicable law, whichever is
lower.


 


7.5          Limits on Indemnification.  Notwithstanding the general indemnification
provisions at Section 7.1
or with respect to Section
7.2 of this License Agreement, the Parties have agreed to
apportion their respective liabilities as follows:


 


7.5.1       SBI shall be
responsible for any Losses of MPI resulting from an act or omission of SBI
committed prior to the Effective Date.


 


7.5.2       MPI shall be responsible
for any Losses of SBI resulting from an act or omission of MPI, whether
committed prior to or after the Effective Date (including, without limitation,
any such Losses arising out of Third Party claims that MPI’s practice of the
Joint Patent Rights infringes or misappropriates the intellectual property
rights of such Third Party).


 


7.6          Disclaimer Concerning Technology.  Except as expressly provided in Article 6 of
this License Agreement, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS
PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS,” AND EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE
PRACTICES, IN ALL CASES WITH RESPECT THERETO. 
Except as expressly provided in Article 6, each Party disclaims any
implied warranty as to the noninfringement of the intellectual property rights
of Third Parties.


 












***Confidential
Treatment Requested


 


14

















 


7.7          DISCLAIMER.  EXCEPT AS PROVIDED IN THIS ARTICLE 7, NEITHER PARTY SHALL BE LIABLE TO
THE OTHER UNDER THIS LICENSE AGREEMENT FOR ANY SPECIAL, CONSEQUENTIAL OR
INCIDENTAL DAMAGES, INCLUDING ANY LOSS OF PROFITS OR LOSS OF ANY BUSINESS
OPPORTUNITY.


 


ARTICLE 8



NON-DISCLOSURE


 


8.1          Nondisclosure.


 


8.1.1       During the term of this
Agreement and for seven (7) years thereafter without regard to the means of
termination, neither SBI nor MPI shall use, for any purpose other than the
purpose of this Agreement, reveal or disclose to any Third Party information
and materials disclosed by the other Party (whether prior to or during the term
of this Agreement), and marked as confidential or which the receiving Party
knows or has reason to know are or contain trade secrets or other proprietary
information of the other Party, including information provided by a Party to
another Party prior to the Effective Date (“Confidential Information”) without first obtaining the
written consent of the other Party, except (i) as may be required for
securing Regulatory Approval, including pricing approval in the Territory or as
may otherwise be required to be disclosed to an Agency in the Territory; or (ii) as
required by law or court order (subject to seeking confidential treatment where
available and prior notification to the disclosing Party); or (iii) as
required in connection with any filings made with, or by the disclosure
policies of a major stock exchange (subject to seeking confidential treatment
where available; or (iv) MPI shall have the right to provide Confidential
Information of SBI to MPI’s Affiliates and MPI’s and its Affiliates’
Sublicensees, distributors and partners (and to their potential Sublicensees,
distributors and partners) for use consistent with the purposes and terms of
the License Agreement.  This
confidentiality obligation shall not (a) apply to such information which
is or becomes a matter of public knowledge; (b) is already in the possession
of the receiving Party (other than as a result of prior disclosure by the
disclosing Party pursuant to the Agreement); (c) is disclosed
non-confidentially to the receiving Party by a Third Party having the right to
do so; (d) is subsequently and independently developed by employees of the
receiving Party or Affiliates thereof who had no knowledge of the Confidential
Information disclosed.  The Parties
shall take reasonable measures to assure that no unauthorized use or disclosure
is made by others to whom access to such information is granted.


 


8.1.2       MPI and SBI agree to
limit the disclosure of any Confidential Information received hereunder to such
of its employees and consultants and its Affiliates and with respect to SBI,
SBI’s and its Affiliates’ sublicensees, distributors and partners ( and to
their potential sublicensees, distributors and partners) as are necessary to
carry out the provisions of this Agreement and who are likewise bound by
written obligations of confidentiality which are comparable to, or more
stringent than, the provisions of Section 8.1.;


 


8.2          Press Releases and Public
Announcements.  It is
understood that either Party may, subject to the terms and conditions of this
Section, issue a press release announcing the execution of this Agreement as
well as subsequent press releases relating to the Agreement or activities
thereunder.  The Parties agree to
consult with each other reasonably and in good faith 


 


15

















 


with respect to the text and timing of such press
releases prior to the issuance thereof. 
Either Party may issue such press releases (after providing three weeks
advance written notice as to text and timing of such release) as it determines,
based on advice of counsel, are reasonably necessary to comply with laws or
regulations or for appropriate market disclosure.  In addition, following the initial press release announcing this
Agreement, either Party shall be free to disclose, without the other Party’s
prior written consent, the existence of this Agreement, the identity of the
other Party and those terms of the Agreement which have already been publicly
disclosed in accordance herewith.


 


8.3          Termination.  The Parties agree that if this Agreement is
terminated, neither Party shall disclose to any Third Party any reason for not
proceeding without the express written consent of the other Party, and the
Parties shall agree on statements for public disclosure, such agreement not to
be unreasonably withheld or delayed.  


 


ARTICLE 9



TRADEMARKS


 


9.1          MPI Trademarks.  MPI shall have the right to select and shall
own and pay for all trademarks, service marks, designs and trade dress used by
MPI or its Affiliates or their distributors or sublicensees in connection with
the Products in each country of the Territory.


 


ARTICLE 10



PATENT
PROSECUTION AND MAINTENANCE


 


10.1        Patent Prosecution and Maintenance.  MPI
shall be responsible for the preparation, filing, prosecution and maintenance
of all MPI Patent Rights and Joint Patent Rights at MPI’s sole expense.  SBI shall be responsible for the
preparation, filing, prosecution and maintenance of all SBI Patent Rights at
SBI’s sole expense.


 


10.1.1     MPI shall consult with
SBI as to the preparation, filing, prosecution and maintenance of Joint Patent
Rights reasonably prior to any deadline or action with the U.S. Patent &
Trademark Office or any foreign patent office, and shall furnish to SBI copies
of all relevant documents reasonably in advance of such consultation.  In the event that MPI desires to abandon any
Joint Patent Right, or if MPI later declines responsibility for any Joint
Patent Right, MPI shall provide reasonable prior written notice to SBI of such
intention to abandon or decline responsibility (which notice shall, in any
event, be given no later than 60 days prior to the next deadline for any
action that may be taken with respect to such Joint Patent with the U.S. Patent
& Trademark Office or any foreign patent office), and SBI shall have the
right, at its expense, to prepare, file, prosecute, and maintain such Joint
Patent Right.  If SBI elects to prepare,
file, prosecute, and maintain such Joint Patent Right, MPI shall cease to have
an exclusive license to such Joint Patent Right under this Agreement, but each
Party shall continue to own its one-half undivided interest in such Joint
Patent Right.


 


10.1.2     SBI shall consult with
MPI as to the preparation, filing, prosecution and maintenance of SBI Patent
Rights reasonably prior to any deadline or action with the U.S. Patent


 


16

















 


& Trademark Office or any foreign patent office,
and shall furnish to MPI copies of all relevant documents reasonably in advance
of such consultation.  In the event that
SBI desires to abandon any SBI Patent Right, or if SBI later declines
responsibility for any SBI Patent Right, SBI shall provide reasonable prior
written notice to MPI of such intention to abandon or decline responsibility
(which notice shall, in any event, be given no later than 60 days prior to
the next deadline for any action that may be taken with respect to such SBI
Patent with the U.S. Patent & Trademark Office or any foreign patent
office), and MPI shall have the right, at its expense, to prepare, file,
prosecute, and maintain such SBI Patent Right.


 


ARTICLE 11



INFRINGEMENT
OF THIRD PARTY PATENTS; ENFORCEMENT


 


11.1        Enforcement of SBI Patent Rights and
Joint Patent Rights.


 


11.1.1     Upon learning of any
infringement of an MPI Patent Right, SBI Patent Right or Joint Patent Right by
a Third Party in the Territory, SBI or MPI, as the case may be, shall promptly
provide notice to the other Party in writing of the fact and shall supply the
other Party with all evidence possessed by the notifying Party pertaining to
said infringement.


 


11.1.2     MPI
Patent Rights. 
MPI shall have the first right to bring and control any action or
proceeding with respect to infringement of any MPI Patent Right at its own
expense and by counsel of its own choice. 
With respect to infringement of any MPI Patent Right that is likely to
have a material adverse effect on any Product being developed or commercialized
by MPI, its Affiliates or its Sublicensees with respect to which SBI is
entitled to royalty or other payments hereunder, SBI shall have the right, at
its own expense, to be represented in any such action by counsel of its own
choice, and if MPI fails to bring an action or proceeding within
(a) 60 days following the notice of alleged infringement or
(b) 10 days before the time limit, if any, set forth in the
appropriate laws and regulations for the filing of such actions, whichever
comes first, SBI shall have the right to bring and control any such action at
its own expense and by counsel of its own choice, and MPI shall have the right,
at its own expense, to be represented in any such action by counsel of its own
choice.


 


11.1.3     SBI
Patent Rights. 
SBI shall have the first right to bring and control any action or
proceeding with respect to infringement of any SBI Patent Right at its own
expense and by counsel of its own choice. 
With respect to infringement of any SBI Patent Right that is likely to
have a material adverse effect on any Product being developed or commercialized
by MPI, its Affiliates or its Sublicensees, MPI shall have the right, at its
own expense, to be represented in any such action by counsel of its own choice,
and if SBI fails to bring an action or proceeding within (a) 60 days
following the notice of alleged infringement or (b) 10 days before
the time limit, if any, set forth in the appropriate laws and regulations for
the filing of such actions, whichever comes first, MPI shall have the right to
bring and control any such action at its own expense and by counsel of its own
choice, and SBI shall have the right, at its own expense, to be represented in
any such action by counsel of its own choice.


 


11.1.4     Joint
Patent Rights. 
MPI shall have the first right to bring and control any action or
proceeding with respect to infringement of any Joint Patent Right at its own 


 


17

















 


expense and by counsel of its own choice, and SBI
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice.  If MPI
fails to bring an action or proceeding within (a) 60 days following
the notice of alleged infringement or (b) 10 days before the time limit,
if any, set forth in the appropriate laws and regulations for the filing of
such actions, whichever comes first, SBI shall have the right to bring and
control any such action at its own expense and by counsel of its own choice,
and MPI shall have the right, at its own expense, to be represented in any such
action by counsel of its own choice.


 


11.1.5     In the event a Party
brings an infringement action in accordance with this Section 11.1, the other
Party shall cooperate fully, including, if required to bring such action, the
furnishing of a power of attorney or being named as a party.  The Party controlling any such action may
not settle or consent to an adverse judgment without the express written
consent of the non-controlling Party (such consent not to be unreasonably
withheld or delayed).  Except as
otherwise agreed to by the Parties as part of a cost-sharing arrangement, any
recovery realized as a result of such litigation, after reimbursement of any
litigation expenses of MPI and SBI, shall be retained by the Party that brought
and controlled such litigation for purposes of this License Agreement, except
that any recovery realized by MPI as a result of such litigation, after
reimbursement of the Parties’ litigation expenses, shall, to the extent
attributable to lost sales with respect to Products, be treated as Net Sales
for purposes of this License Agreement.


 


11.2        Infringement of Third Party Rights.  Each Party shall promptly
notify the other in writing of any allegation by a Third Party that the
activity of either of the Parties pursuant to this License Agreement infringes
or may infringe the intellectual property rights of such Third Party.  MPI shall have the sole right to control any
defense of any such claim involving alleged infringement of Third Party rights
by MPI’s activities at its own expense and by counsel of its own choice, and
SBI shall have the right, at its own expense, to be represented in any such
action by counsel of its own choice. 
SBI shall have the sole right to control any defense of any such claim
involving alleged infringement of Third Party rights by SBI’s activities at its
own expense and by counsel of its own choice, and MPI shall have the right, at
its own expense, to be represented in any such action by counsel of its own
choice.  Neither Party shall have the
right to settle any patent infringement litigation under this Section 11.2
in a manner that diminishes the rights or interests of the other Party without
the written consent of such other Party (which shall not be unreasonably
withheld or delayed).


 


ARTICLE 12



TERMINATION


 


12.1        Early Termination.


 


12.1.1     If MPI commits a material
breach of any material term or condition of this License Agreement solely as a result
of MPI’s failure to pay SBI amounts owed to SBI (provided  that
neither the amount or the obligation to pay such amount is in dispute between
the Parties), and MPI fails to cure such breach within thirty (30) days after
receiving written notice of the breach from SBI, SBI shall have the right to
terminate this License Agreement upon written notice to MPI at the end of such
thirty (30) day period for MPI’s uncured breach.  In the event of any dispute as to any amount payable to SBI, MPI
shall pay the full amount not in dispute and


 


18

















 


the dispute regarding the remaining amount shall be
submitted to arbitration pursuant to Section 14.5.


 


12.1.2     If either Party commits a
material breach of any material term or condition of this License Agreement
(except as set forth in Section 12.1.1), the non-breaching Party may give
the other Party written notice of the breach, and if the breach is not cured
within sixty (60) days after receiving written notice of the breach, the
non-breaching Party shall have the right to submit the matter to arbitration
pursuant to Section 14.5
for resolution within thirty (30) days of the end of such sixty (60) day period
by giving the other Party written notice requesting arbitration within such
thirty (30) day period.  The Parties
shall continue to perform their obligations hereunder during the pendency of
such arbitration, except to the extent mutually agreed otherwise by the Parties
or except as directed by the arbitrators. 
The arbitrators’ decision shall be binding upon the Parties except that
in no event shall the arbitrators have the power or authority to terminate this
License Agreement.


 


ARTICLE 13



EXPIRATION;
EFFECT OF TERMINATION


 


13.1        Expiration.  Upon expiration of this License Agreement
(either in its entirety or with respect to any country), MPI shall continue to
have the right, itself and/or through or with its Affiliates or any of their
designees, to develop, have developed, make, have made, use, distribute, offer
for sale, import, export and sell Products in such country or countries with
respect to which this License Agreement has expired and shall have a fully
paid-up, non-exclusive, irrevocable license in such countries under the rights
licensed to MPI pursuant to Article 2.


 


13.2        Effect of Expiration or Termination.  Except as otherwise expressly set forth in
this License Agreement, upon expiration or termination of this License
Agreement, all rights, licenses, properties and interests granted by each Party
to the other Party shall immediately revert to and become fully vested in the
granting Party, and the other Party shall return to it all documents and any
Confidential Information supplied to it or its Affiliates by the other Party.  Without limiting the generality of the
foregoing, each Party will have the right to practice the Joint Patent Rights
without the consent of, or any obligation to account to, the other Party for
such practice.


 


13.3        Survivability.  Expiration or termination of this License
Agreement shall not relieve the Parties of any obligation accruing prior to
such expiration or termination, including, without limitation, either Party’s
obligations to pay any amount accruing to the other Party under the provisions
of this License Agreement while it was in effect.  Further, the expiration or termination of this License Agreement
shall not affect any rights and obligations of the Parties under this License
Agreement which are intended by the Parties to survive such termination.  Without limiting the generality of the
foregoing, the following provisions of this License Agreement shall survive
expiration or termination hereof: 
Articles 7, 8, 10, 11, 13 and 14.


 


19

















 


13.4        No Damages on Termination.  Neither Party shall be entitled to any
compensation whatsoever as a result of termination of this License Agreement,
but without limiting either Party’s damages for any breach of this License
Agreement.


 


ARTICLE 14


 


MISCELLANEOUS


 


14.1        Force Majeure.  If either Party is prevented from complying,
either totally or in part, with any of the terms or provisions of this License
Agreement, by reason of force majeure, including, but not limited to fire,
flood, earthquake, explosion, storm, strike, lockout or other labor trouble,
riot, war, rebellion, accident, acts of God and/or any other cause or
externally induced casualty beyond its reasonable control, whether similar to
the foregoing matters or not, then, upon written notice by the Party liable to
perform to the other Party, the requirements of this License Agreement or such
of its provisions as may be affected, and to the extent so affected, shall be
suspended during the period of such disability.


 


14.2        No Assignment.  Neither Party shall, without the prior
written consent (not to be unreasonably withheld) of the other Party having
been obtained, assign or transfer this License Agreement to any Person,
provided, however, that each Party may assign or transfer this License
Agreement to any successor by merger or sale of stock of such Party or its
business unit to which this License Agreement relates, or upon a sale of all or
substantially all of such Party’s assets, without the prior written consent of
the other Party hereto (provided that, in the event of any such merger or stock
or asset sale, no intellectual property rights of a Third Party involved in
such transaction will be included in the technology licensed hereunder).  Notwithstanding the foregoing, either Party
shall be permitted to perform this License Agreement, in whole or in part,
through an Affiliate of such Party or assign this License Agreement, in whole
or in part, to an Affiliate of such Party, so long as the assigning Party shall
remain liable for performance by such Affiliate.  This License Agreement shall be binding upon and shall inure to
the benefit of the Parties and their successors and permitted assigns.


 


14.3        Notices.  Any notices required or permitted to be
given hereunder shall be in writing in the English language and shall be
delivered in person or by DHL, Federal Express (or other courier service
requiring signature upon receipt) or sent by air mail, postage prepaid, or
facsimile (confirmed by a telephone conversation with the recipient) to the
addresses set forth below.  The Parties
may change the address at which notice is to be given by giving notice to the
other Party as herein provided.  All
notices shall be deemed effective upon receipt by the Party to whom it is
addressed.


 


20

















 


If to MPI:


 


Maxim Pharmaceuticals,
Inc.


8899 University Center
Lane


Suite 400


San Diego, California
92122


U.S.A.


Attention:  Finance Department


Fax:  (858) 453-5005


Phone:  (858) 453-4040


 


If To SBI:


 


Shire BioChem Inc.


275 Armand-Frappier Boulevard


Laval, Quebec, Canada   H7V 4A7


Attention:  Legal Affairs


Fax:  (450) 978-7739


Phone:  (450) 978-7768


 


14.4        Governing Law.  This License Agreement and its execution,
validity and interpretation shall be governed in all respects in accordance
with the laws of the State of New York, the United States of America, other
than its conflict of law rules except for Section 5-1401 of the New York
General Obligations Law.  The Parties
expressly exclude any application of the United Nations Convention on Contract
for the Sale of Goods to this License Agreement.


 


14.5        Dispute Resolution.


 


14.5.1     The Parties shall
initially attempt in good faith and best efforts to resolve any significant
controversy, claim, or dispute arising out of or relating to this License
Agreement or any significant breach thereof (hereinafter collectively referred
to as a “Dispute”)
through face-to-face negotiations between the Senior Executive Officers of SBI
and MPI.  If the Dispute is not resolved
within thirty (30) days (or such other period of time mutually agreed upon by
the Parties) of commencing such face-to-face negotiations, or if the Party
against which a claim has been asserted refuses to attend such negotiations or
does not otherwise participate in such negotiations within thirty (30) days (or
such other period of time mutually agreed upon by the Parties) from the date of
notice of a Dispute, then the Parties agree to mediation with a mutually agreed
mediator.  If the mediation of such
Dispute does not commence within thirty (30) days (or such other period of time
mutually agreed upon by the Parties) of the end of such face-to-face
negotiations, or if the Dispute is not resolved within thirty (30) days (or
such other period of time mutually agreed upon by the Parties) of commencing
such mediation, or if the Party against which a claim has been asserted refuses
to attend either face-to-face negotiations or such mediation, or the Parties
are unable to agree upon a mediator, then the Parties agree to submit the
Dispute to arbitration as provided herein. 
Unless otherwise mutually agreed by the Parties, only if the Dispute is
not resolved through face-to-face negotiations or mediation as set forth above
in this Section 14.5, may a Party resort to arbitration.


 


21

















 


14.5.2     Except as provided in
this Section 14.5, all Disputes relating in any way to this License
Agreement shall be resolved exclusively through arbitration conducted under the
auspices of the Center for Public Resources (“CPR”) pursuant to CPR’s Model ADR
Procedure: Non-Administered International Arbitration Rules and
Commentary.  The arbitration shall be
conducted in the English language before three (3) arbitrators, one selected by
each Party and the third to be selected by the other two.  Unless otherwise mutually agreed by the
Parties, any arbitration brought hereunder shall be brought only and
exclusively in New York, New York.  The
arbitrators shall hear evidence by each Party and resolve each of the issues
identified by the Parties.  The
arbitrators shall render a formal, binding non-appealable resolution and award
on each issue as expeditiously as possible, but not more than fifteen (15)
business days after the hearing.  In any
arbitration, the prevailing Party shall be entitled to reimbursement of its
reasonable attorneys’ fees and the Parties shall use all reasonable efforts to
keep arbitration costs to a minimum.


 


14.5.3     In no event shall the
arbitrators have the power or authority to terminate this License Agreement in
whole or in part.


 


14.5.4     Nothing in this License
Agreement shall be deemed as preventing either Party from seeking injunctive
relief (or any other provisional remedy) from any court having jurisdiction
over the Parties and the subject matter of the dispute as necessary to protect either
Party’s intellectual property.


 


14.6        Interpretation.  This License Agreement is executed in the
English language.  This License
Agreement shall be deemed to comprise the language mutually chosen by the
Parties, has been prepared jointly and no rule of strict construction shall be
applied against either Party.  In this
License Agreement, the singular shall include the plural and vice versa
and the word “including” shall be deemed to be followed by the phrase “without
limitation”.  Les
parties reconnaissent leur volonté expresse que la présente convention ainsi
que tous les documents et conventions qui s’y rattachent directment ou
indirectment soient rédigés en langue anglaise.


 


14.7        Severability.  In the event that any provision of this
License Agreement shall be held to be unenforceable, invalid or in
contravention of applicable law, such provision shall be of no effect, and the
Parties shall negotiate in good faith to replace such provision with a
provision which effects to the extent possible the original intent of such
provision.


 


14.8        Complete Agreement.  This License Agreement together with all
Exhibits hereto, supersedes all prior understandings, agreements,
representations and warranties between the Parties, oral or written with
respect to the present subject matter, and comprises the complete agreement
between the Parties with respect to the present subject matter.  For the avoidance of any doubt, this License
Agreement supercedes and cancels the Research and License Agreement between the
Parties hereto dated July 10th, 2000.  In consequence of the termination of the Agreement, the Parties
release and discharge each other of any and all liabilities, obligation or
cause of action with regards to said Agreement.


 


14.9        Modifications.  No terms or provisions of this License
Agreement shall be varied or modified by any prior or subsequent statement,
conduct or act of either of the Parties, except


 


22

















 


that the Parties may amend this License Agreement by
written instruments specifically referring to this License Agreement and
executed by a duly authorized officer of each of the Parties.


 


14.10      No Agency.  Neither Party shall by virtue of this
License Agreement have any power to bind the other to any obligation nor shall
this License Agreement create any relationship of agency, partnership or joint
venture or any fiduciary relationship.


 


14.11      No Waiver.  No term or condition of this License
Agreement shall be considered waived unless reduced to writing and duly
executed by a duly authorized officer of the waiving Party.  Any waiver by any Party of a breach of any
term or condition of this License Agreement will not be considered as a waiver
of any subsequent breach of this License Agreement, of that term or condition
or any other term or condition hereof.


 


14.12      Rights in Bankruptcy.  All rights and licenses
granted under or pursuant to this License Agreement by a Party (the “Grantor”) are, and
will otherwise be deemed to be, for purposes of Section 365(n) of the U.S.
Bankruptcy Code, licenses of right to “intellectual property” as defined under
Section 101 of the U.S. Bankruptcy Code. 
The Parties agree that the Party to which such licenses are granted (the
“Grantee”),
as licensee of such rights under this License Agreement, will retain and may
fully exercise all of its rights and elections under the U.S. Bankruptcy
Code.  The Parties further agree that,
in the event of the commencement of a bankruptcy proceeding by or against the
Grantor under the U.S. Bankruptcy Code, the Grantee will be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property, and
same, if not already in its possession, will be promptly delivered to it
(i) upon any such commencement of a bankruptcy proceeding upon its written
request therefor, unless the Grantor elects to continue to perform all of its
obligations under this License Agreement, or (ii) if not delivered under
(i) above, following the rejection of this License Agreement by or on behalf of
the Grantor upon written request therefor by the Grantee.


 


14.13      Counterparts.  The Agreement may be executed simultaneously
in one or more counterparts, each one of which need not contain the signature
of more than one Party but such counterparts taken together shall constitute
one and the same agreement.


 


14.14      IN WITNESS WHEREOF, the
Parties have executed this License Agreement as of the date first above
written.


 


	
  MAXIM PHARMACEUTICALS, INC.

  	
   

  	
  SHIRE BIOCHEM INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Dale A.
  Sander

  	
   

  	
  By: 

  	
  /s/ Richard
  Bethell

  
	
  Name:  Dale
  A. Sander 

  	
   

  	
  Name:  Richard
  Bethell

  
	
  Title:    VP,
  Corporate Development 

  	
   

  	
  Title:    Vice
  President, Therapeutic Research  

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date

  	
  2 March 2004

  	
   

  	
   

  	
  Date:  2004-March-01

  
							



 


23

















 


	
  CYTOVIA, INC.

  
	
   

  
	
   

  
	
  By: 

  	
  /s/ Larry G.
  Stambaugh

  	
   

  
	
  Name:  Larry
  G. Stambaugh

  
	
  Title:   Chief
  Executive Officer

  
	
   

  
	
   

  
	
  Date  

  	
  2 March 2004

  	
   

  
					



 


24

















 


EXHIBIT A


 


JOINT PATENT RIGHTS


 


See attached documents (5
pages)


 


[***]


 


	
  MPI’s Intitials:  DAS

  
	
  SBI’s Initials:  RB

  
	
  
  

  

  

  
	
  ***Confidential
  Treatment Requested

  



 

















 


EXHIBIT B


 


MPI PATENT RIGHTS


 


See attached document (1
page)


 


[***]


 


	
  MPI’s Intitials:  DAS

  
	
  SBI’s Initials:  RB

  
	
  
  

  

  

  
	
  ***Confidential
  Treatment Requested

  



 

















 


EXHIBIT C


 


PRODUCT


 


The “Product”  means any member of the class of
substituted 4-H chromenes, analogs and derivatives set forth below:


 


[***]


 


	
  MPI’s Intitials:  DAS

  
	
  SBI’s Initials:  RB

  
	
  
  

  

  

  
	
  ***Confidential
  Treatment Requested

  



 

















 


EXHIBIT D


 


SBI KNOW-HOW


 


[***]


 


	
  MPI’s Intitials:  DAS

  
	
  SBI’s Initials:  RB

  
	
  
  

  

  

  
	
  ***Confidential
  Treatment Requested

  



 

















 


EXHIBIT E


 


SBI PATENT RIGHTS


 


NONE


 


[***]


 


	
  MPI’s Intitials:  DAS

  
	
  SBI’s Initials:  RB

  
	
  
  

  

  

  
	
  ***Confidential
  Treatment Requested