**Exhibit10.1**

** **

**ConfidentialTreatment Requested**

**Under17 C.F. R. §§ 200.80(b)(4),**

**200.83and 240.24b-2**

 

**LICENSE AGREEMENT**

 

**THIS LICENSE AGREEMENT** (***“License Agreement”***)******is entered into andmade on March 1st, 2004 (the “Effective Date”) by and between:(a) on the one hand, **SHIRE BIOCHEM INC.** (***“SBI”***), a corporation organized and existingunder the laws of Canada and wholly-owned subsidiary of Shire, having itsprincipal office at 275 Armand-Frappier Boulevard, Laval, Quebec, CanadaH7V 4A7; and (b) on the other hand, **MAXIM PHARMACEUTICALS, INC.** (***“Maxim”***), acorporation incorporated and existing under the laws of the State of Delaware,having its principal office at 8899 University Center Lane, Suite 400, SanDiego, California 92122, U.S.A, and **CYTOVIA,INC.** (***“Cytovia”***),a corporation incorporated and existing under the laws of the State of Delawareand a wholly-owned subsidiary of Maxim, having the same principal office asMaxim (Maxim and Cytovia are hereinafter collectively referred to as ***“MPI”***).  SBI and MPI are hereinafter collectivelyreferred to as ***“Parties***”or individually as a ***“Party.”***

 

**RECITALS**

 

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

 

**WHEREAS**pursuant to said Agreement, Cytovia granted SBI an exclusive license toresearch, develop and commercially exploit Cytovia’s intellectual propertyrelating 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 theResearch Term of the Agreement;

 

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

 

**NOW, THEREFORE,** in consideration of themutual covenants contained herein, and for other good and valuableconsideration, the amount and sufficiency of which are hereby acknowledged, theParties hereby agree as follows:

 

**ARTICLE 1**

**DEFINITIONS**

 

**1.1          *“Affiliate”*** means at thetime of determination (i) any Person which is directly or indirectlycontrolled by any Party hereto; (ii) any Person which directly orindirectly controls any

 

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

 

**1.2          *“Agency”*** means anygovernmental regulatory authority responsible for granting Regulatory Approvalsfor the sale of Product.

 

**1.3          *“Control”*** or ***“Controlled”*** in thecontext of intellectual property rights means rights to intellectual propertysufficient to grant the applicable license or sublicense under this LicenseAgreement, without violating the terms of any agreement or other arrangementwith any Third Party, provided that where a license or sublicense under thisLicense Agreement shall be exclusive, if the granting Party does not have theright under a Third Party agreement entered into prior to the Effective Date togrant an exclusive license or sublicense, such license or sublicense shall benon-exclusive.

 

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

 

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

 

**1.6          *“Field”*** means thetreatment of human diseases.

 

**1.7          *“GCP”*** means ***“Good Clinical Practices”***as defined under applicable FDA rules and regulations and Guideline E-6 of theInternational 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 ornon-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 ClinicalTrials.

 

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

 

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

 

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

 

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Territoryafter the receipt of Regulatory Approval for the Product from the relevantAgency, as may be necessary in such country.

 

**1.13        *“Loss”*** has the meaningset forth in ***Section 7.1***.

 

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

 

**1.15        *“MPI Know-How”*** means allproprietary Technical Information owned or Controlled by MPI as of theEffective Date or during the term of this License Agreement and that relatesto, 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 orControlled by MPI as of the Effective Date or during the term of this License Agreementthat 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 ofmanufacture, or method of use of such Product. MPI Patent Rights as they exist as of the Effective Date are set forthon ***Exhibit B***hereto.

 

**1.17        *“NDA”*** means a “New DrugApplication,” as defined in the United States Food, Drug and Cosmetic Act, asamended, and applicable FDA rules and regulations, or any non-U.S. equivalentthereof.

 

**1.18        *“Net Sales”*** means thetotal gross sales (number of units shipped times the invoiced price per unit)to Third Parties representing sales invoiced by MPI and its Affiliates (but notSublicensees) of the Product in the Territory, less deductions for thefollowing to the extent actually paid or allowed:

 

**(a)          **sales and excisetaxes and duties (including import duties) paid or allowed by a selling partyand any other governmental charges imposed upon the manufacture or sale of theProduct;

 

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

 

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

 

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

 

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

 

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Inaddition, MPI shall be entitled to deduct from Net Sales any receivables whichare deemed to be uncollectible according to MPI’s internal accountingprinciples and generally accepted accounting principles consistentlyapplied.  Such bad debt deduction shallbe applied to Net Sales in the period in which such receivables are written offand shall be exclusive of any bad debt or uncollectible receivables of MPI orits Affiliates unrelated to the Products.

 

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

 

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

 

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

 

**1.20        *“Person”*** shall include acorporation, partnership or other entity.

 

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

 

**1.24       *****“Product”*** means anymember of the class of substituted 4-H chromenes, analogs and derivativesthereof as describedin ***Exhibit C***hereto and any compound encompassed by the 

 

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generic chemical formulae included inthose 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 formarketing a Product in a particular country in the Territory, including anyapproval for price or reimbursement (hereinafter, “pricing approval”) as may benecessary or appropriate in such country.

 

**1.26        *“SBI Know-How”*** means allproprietary Technical Information owned or Controlled by SBI as of theEffective Date and that relatesto, or is necessary or useful for the design, synthesis, identification,research, development, manufacture, use or sale of the Products as more fullyappears from ***Exhibit D***attached hereto.

 

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

 

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

 

**1.29        *“Sublicensing Fees”***shall mean the amount actually paidto MPI or an Affiliate of MPI by a Sublicensee arising from the sublicense ofthe 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 orlicense fees, milestone payments, royalties payable to MPI or its Affiliates bya Sublicensee based on such Sublicensee’s sale of Products, premiums abovemarket price on sales of securities and any other payments in respect of aSublicense but shall not include any payments tied directly to the provision ofgoods and services incurred and expensed at fair market value for such goodsand services by MPI or its Affiliate to such Sublicensee (including researchand development and manufacturing) to compensate MPI or its Affiliate for theprovision of such goods and services, or payments for securities (other thanpremiums above market price).

 

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

 

**1.31        *“Territory”*** means allthe countries of the world.

 

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

 

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**1.33        *“Valid Patent Claim”***means a claim of an issued and unexpiredPatent or a claim of a pending patent application within the MPI PatentRights, SBI Patent Rights or Joint Patent Rights, which claim has not lapsed,been canceled, become abandoned, or been revoked or declared invalid orunenforceable by an unreversed and unappealable decision or judgment of a courtor other governmental agency of competent jurisdiction, and which has not beenadmitted to be invalid or unenforceable through reissue or disclaimer orotherwise.  For the purposes of thisLicense Agreement, a claim of a pending patent application shall only be deemeda Valid Patent Claim for a period of five (5) years from the date of firstpublication of such application in those countries where applications arepublished or, in those countries where applications are not published, for aperiod of five (5) years from filing of such application.  If a claim of a pending patent applicationdoes not mature into an issued patent within the aforementioned five (5) yearperiod of time, such a claim will no longer qualify as a Valid Patent Claim.

 

**ARTICLE 2****LICENSEGRANTS**

 

**2.1          SBILicense Grant.**

 

**2.1.1      **Subject to the termsand conditions of this License Agreement, during the term of this LicenseAgreement, SBI hereby grants to MPI an exclusive, worldwide, royalty-bearinglicense, including the right to grant sublicenses (which themselves may includethe right to grant further sublicenses), under the SBI Patent Rights, the SBIKnow-How and SBI’s interest in the Joint Patents, to research, develop, makeand 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” asused in Section 2.1.1 shall operate to exclude all others, including SBIand its Affiliates, from the rights conferred by SBI pursuant toSection 2.1.1.  SBI shall not,during the term of this License Agreement, either itself or through anyAffiliate, conduct any research, development or commercialization activitieswith respect to any Product or enter into any agreement with any Third Partywith respect to research, development or commercialization of any Product.

 

**2.1.3      **All rights and licensesgranted by MPI to SBI under MPI Patent Rights and MPI Know-How pursuant to theAgreement are hereby terminated and shall revert to MPI as of the EffectiveDate.

 

**2.2          Transferof SBI Know-How.**

 

**2.2.1      **Concurrent with theexecution of the License Agreement, SBI shall use commercially reasonableefforts to transfer to MPI the SBI Know-How related to the Product which willinclude, without limitation, Structure Activity Relationship (SAR) data andmedicinal 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 onthe Effective Date and unless sooner terminated by mutual agreement or pursuantto any other provision of this License Agreement shall expire, on acountry-by-country basis upon the later of (i) expiration of the last to expireof the Valid Patent Claims covering the manufacture, use or sale of eachProduct 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****REGULATORYACTIVITIES, APPROVALS, and COMPLIANCE**

 

**4.1          Regulatory Activities and Approvals.**

 

**4.1.1      **MPI shall beresponsible for, either itself or through its designee, and fund allpre-clinical and non-clinical work, all clinical trials and all otherregulatory matters relating to the Products, including all communications withthe relevant Agencies with respect to the Products in the Territory.  MPI shall be responsible for thepreparation, filing and prosecution of all INDs, as well as all other Agencyfilings for obtaining and maintaining Regulatory Approvals in theTerritory.  MPI shall own all suchfilings and Regulatory Approvals during and after the term of this LicenseAgreement.

 

**4.1.2      **MPI shall usecommercially reasonable efforts to develop a Product or Products, obtain orhave obtained Regulatory Approvals of such Product or Products in one or moreof the Major Countries and, following said Regulatory Approval, market and sellor have marketed and sold such Product or Products in any Major Countries.  In furtherance of the above, MPI shallprovide SBI on an annual basis with a reasonably detailed progress reportoutlining MPI’s efforts to develop a Product or Products, progress in obtainingRegulatory Approvals of such Products in any Major Countries.  Failure by MPI to provide SBI with theaforesaid progress report shall constitute a breach under this LicenseAgreement.

 

**ARTICLE 5****LICENSEPAYMENTS, CLINICAL TRIALAND REGULATORY APPROVAL MILESTONES; ROYALTIES AND REPORTS**

 

**5.1          Clinical Trial, Regulatory Approvaland 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 theachievement of each of the respective clinical trial, regulatory approval, andcommercialization milestones by MPI or its Affiliate in a Major Market whereMPI has not granted development or commercialization rights with respect toProducts to any Sublicensee, *provided that*, (i) **[***]** shall **[***]** be payable under this Section 5.1 (*i.e.*, the maximum amount that may bepayable pursuant to this Section 5.1 is **[***]**),notwithstanding the 

 

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total number of Products developed or indicationspursued or approved or the number of Major Markets in which any Product is developedor approved; and (ii) in the event that a Product shall be discontinuedafter any milestone shall have been paid, such milestone shall be creditedagainst the milestone due for any Product subsequently pursued.  In the event that a subsequent milestoneshall be triggered where a prior milestone has not been triggered (for example,Phase III trials shall be initiated without prior initiation of Phase IItrials), then both milestones shall be payable upon the happening of thesubsequent milestone.  For purposes ofclarification, if any of the milestones set forth in this Section 5.1 isachieved by a Sublicensee, no milestone payment shall be due under thisSection 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                     |   | **[***]**   |

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**5.2          Royalties.**  In all countries of the Territory in whichthere exists a Valid Patent Claim that would, but for the license grantedhereunder or under the Agreement, be infringed by the manufacture, use or saleof the Product as commercialized by MPI or its Affiliate (so long as any claimcovering manufacture excludes others from selling the Product as commercializedby MPI or its Affiliate in the country in question), MPI shall pay to SBI (subjectto the remaining terms and conditions of this ***Section 5.2***) following Launch a royaltyof **[***]**ofNet 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 SBIa royalty of **[***]**of Net Sales of the Product by MPI and its Affiliates (but not bySublicensees), for a maximum of ten (10) years following Launch.  In addition, such **[***]**royalty shall also apply with respectto a Product for the remainder of such ten (10) year period in any countrywhere such a Valid Patent Claim covering manufacture, use or sale of suchProduct as commercialized by MPI or its Affiliate has expired prior to such ten(10) year period.

 

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

 

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publish patent applications, for a period of five (5)years from filing.  In the event thatthe said patent application does not mature into an issued patent within thisfive (5) year period of time, such a patent claim will no longer be deemed aValid Patent Claim and SBI shall refund (or in lieu of such refund, MPI may setoff such amount against any payments owed by MPI to SBI) one-half of anycorresponding payments made at the **[***]**royalty rate so as to yield the rateof **[***]**ofNet Sales of Product set forth above for countries where there is no ValidPatent Claim.  In the event that SBIopts for a set-off rather than an immediate refund of amounts owed to MPI, theamount owed shall accrue interest from the date due, and thus the set-off shallalso include such interest to be computed for such unpaid amount on the lastday of each calendar quarter (accruing quarterly) at the prime or otherequivalent rate of Citibank for the last day of the calendar quarter, or thehighest interest rate permissible under applicable law, whichever islower.  In the event that a Valid PatentClaim covering the Product as commercialized by MPI or its Affiliate shallissue in a country where royalty was paid at the **[***]**level as a result of pendency of apatent application for more than five (5) years as provided herein, then MPIshall pay to SBI (taking into account any refunds made by SBI) the differencebetween the royalty payable at the **[***]**level and that paid at the **[***]**level forthe period of the reduced royalty payments until issue of the Patent, togetherwith interest on such amount at the prime or other equivalent rate of Citibankon the last day of each calendar quarter, or the highest interest ratepermissible under applicable law, whichever is lower, until payment of suchamount by MPI.

 

**5.3          Sublicenses.**  In the event that MPI or any of itsAffiliates sublicenses to a Sublicensee its rights under the licenses grantedby SBI, MPI shall pay SBI **[***]**of all Sublicensing Fees received by MPI orits 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 calendarquarter in which MPI or any of its Affiliate makes Net Sales or receivesSublicensing Fees.  All such paymentsshall be accompanied by a report which sets forth for the preceding calendarquarter the following information:

 

**(a)          **total Net Sales ofProducts sold in the Territory during such period;

 

**(b)          **deductionsapplicable to determining the Net Sales;

 

**(c)          **the exchangerate(s) used to determine amounts owing hereunder;

 

**(d)          **the amount ofroyalties due pursuant to ***Section 5.2***; and

 

**(e)          **Sublicensing Fees.

 

If no payments are due toSBI for any reporting period following Launch, the written report shall sostate.

 

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

 

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using the noon buying rate as published in the *Wall StreetJournal* for the last day of the calendar quarter for which suchpayment is being determined.

 

**5.6          MPI Accounting Obligations and SBIAudit Rights.**  MPIshall keep accurate records for a period of at least five (5) years (or suchlonger period as may correspond to MPI’s internal records retention policy) foreach reporting period during the term of this License Agreement and in whichsales of Products occur showing sales of Products in sufficient detail toenable the reports provided under ***Section 5.4*** to be verified.  SBI shall have the right, for a period ofthree (3) years after receiving any report or statement with respect to NetSales to appoint an independent certified public accountant to inspect the relevantrecords of MPI to verify such report or statement.  MPI shall make its records available for inspection by suchindependent certified public accountant during regular business hours at suchplace or places where such records are customarily kept, upon reasonablenotice, solely to verify the accuracy of the reports and payments.  Such inspection right shall not be exercisedmore than once in any calendar year. Any examination by an independent accounting firm under thisSection is to be made at the expense of SBI, except that if the results ofthe audit reveal that MPI has underpaid SBI by ten percent (10%) or more in anycalendar year, then the audit fees shall be paid by MPI.  Any such discrepancies shall be promptly correctedby payment by MPI to SBI.  The accountingfirm shall execute a confidentiality agreement reasonably acceptable to MPIprior to any such audit limiting the information to be provided to SBI to thenumerical summary of royalties due and paid and prohibiting any disclosure toThird Parties.

 

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

 

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

 

**5.9          Withholding Taxes.**  MPI or its Affiliates shall be entitled todeduct from its payments to SBI the amount of any withholding taxes required tobe withheld by MPI or its Affiliates to the extent MPI or its Affiliates pay tothe appropriate governmental authority on behalf of SBI such taxes.  MPI shall deliver to SBI, upon SBI’srequest, proof of payment of all such taxes and the appropriate documentationwhich is necessary to obtain a tax credit, to the extent such tax credit can beobtained.  Each Party shall provideassistance to the other Party in seeking any benefits available to such Partywith respect to government tax withholdings by any relevant law or double taxtreaty.

 

**5.10        DiscontinuedProduct.** In the eventthat MPI shall in its discretion, discontinue development of a Product that hasbeen designated a candidate drug by MPI, then upon request

 

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

 

**ARTICLE 6****REPRESENTATIONSAND WARRANTIES**

 

**6.1          SBI’s Representations and Warranties.**  SBI hereby represents and warrants thefollowing to MPI:

 

**6.1.1      **SBI (i) is acorporation duly organized, validly existing, and in good standing under thelaws of Canada, with its principal place of business as indicated in the firstparagraph of this License Agreement; (ii) is duly qualified as acorporation and in good standing under the laws of each jurisdiction where itsownership or lease of property or the conduct of its business requires suchqualification, where the failure to be so qualified would have a materialadverse effect on the financial condition of SBI or the ability of SBI toperform its obligations hereunder; (iii) has the requisite corporate powerand authority and the legal right to conduct its business as now conducted;(iv) has all necessary licenses, permits, consents, or approvals from orby, and has made all necessary notices to, all governmental authorities havingjurisdiction, 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, deliveryand performance of this License Agreement by SBI and all instruments anddocuments to be delivered by SBI hereunder: (i) are within the corporatepower of SBI; (ii) have been duly authorized by all necessary or propercorporate action; (iii) are not in contravention of any provision of thecertificate of incorporation or bylaws of SBI; (iv) will not violate theterms of any indenture, mortgage, deed of trust, lease, agreement, or otherinstrument to which SBI is a party or by which SBI or any of its property isbound, which violation would have a material adverse effect on the financialcondition 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 orapproval of, any governmental body, agency, authority or any other person.

 

**6.1.3      **This License Agreementhas been duly executed and delivered by SBI and constitutes a legal, valid andbinding obligation of SBI, enforceable against SBI in accordance with itsterms, except as such enforceability may be limited by applicable insolvencyand other laws affecting creditors’ rights generally or by the availability ofequitable remedies.

 

**6.1.4      **SBI follows reasonablecommercial practices common in the industry to protect its proprietary andconfidential information, including requiring its employees, consultants andagents to be bound in writing by obligations of confidentiality andnon-disclosure and requiring its employees, consultants and agents to assign toit any and all inventions and discoveries discovered by such employees,consultants and/or agents made within the scope of, and during theiremployment, and only disclosing proprietary and confidential

 

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

 

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

 

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

 

**6.1.7      **There are no claims, judgments or settlements against or owed by SBI, orclaims or litigation against SBI pending or threatened in writing, relating toSBI’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 PatentRights and SBI Patent Rights existing as of the Effective Date.

 

**6.2          MPI’s Representations and Warranties.**  MPI hereby represents and warrants thefollowing to SBI:

 

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

 

**6.2.2      **The execution, deliveryand performance of this License Agreement by MPI and all instruments anddocuments to be delivered by MPI hereunder: (i) are within the corporatepower of MPI; (ii) have been duly authorized by all necessary or propercorporate action; (iii) are not in contravention of any provision of thecertificate of incorporation or bylaws of MPI; (iv) will not violate theterms of any indenture, mortgage, deed of trust, lease, agreement, or otherinstrument to which MPI is a party or by which MPI or any of its property isbound, which violation would have a material adverse effect on the financialcondition 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 orapproval of, any governmental body, agency, authority or any other person.

 

**6.2.3      **This License Agreementhas been duly executed and delivered by MPI and constitutes a legal, valid andbinding obligation of MPI, enforceable against MPI in 

 

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

 

**6.2.4      **MPI follows reasonablecommercial practices common in the industry to protect its proprietary andconfidential information, including requiring its employees, consultants andagents to be bound in writing by obligations of confidentiality andnon-disclosure and requiring its employees, consultants and agents to assign toit any and all inventions and discoveries discovered by such employees,consultants and/or agents made within the scope of, and during theiremployment, and only disclosing proprietary and confidential information to theThird Parties pursuant to written confidentiality and non-disclosureagreements.

 

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

 

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

 

**6.2.7      **There are no claims, judgments or settlements against or owed by MPI, orclaims or litigation against MPI pending or threatened in writing, relating toMPI’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 PatentRights existing as of the Effective Date.

 

**ARTICLE 7****INDEMNIFICATION**

 

**7.1          Indemnification.**  Each Party (the “Indemnifying Party”) agreesto indemnify and hold forever harmless the other Party and its Affiliates andeach of their agents, directors, officers and employees from and against anyloss, damage, action, proceeding, cost, expense or liability (includingreasonable attorneys’ fees) (collectively, “Loss”) arising from or inconnection with: the breach or inaccuracy of any representations or warrantiesmade by the Indemnifying Party in this License Agreement.

 

**7.2          Third Party Product Liability Claims.**  MPI agrees to indemnify and hold foreverharmless SBI and its Affiliates and each of their agents, directors, officersand employees from and against any Loss arising from or in connection withThird 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.

 

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**7.3          Procedure.**  The indemnities set forth in this ***Article 7*** aresubject to the condition that the Party seeking indemnity shall forthwithnotify the Indemnifying Party on being notified or otherwise made aware of asuit, action or claim and that the Indemnifying Party defend and control anyproceedings with the other Party being permitted to participate at its ownexpense (unless there shall be a conflict of interest which would preventrepresentation by joint counsel, in which event the Indemnifying Party shallpay for the other Party’s counsel); *provided that* the Indemnifying Party maynot settle the suit or otherwise consent to any judgment in such suit withoutthe written consent of the Indemnified Party (such consent not to beunreasonably withheld).  The Parties shallcooperate in the defense of any Third Party claim.

 

**7.4          Payment.**  Without in any way limiting SBI’sindemnification obligations pursuant to this ***Article 7*** or any other remedies MPI mayhave, if SBI shall not fully compensate MPI as required pursuant to its indemnificationobligations under this ***Article 7***,until such time as SBI shall do so, MPI shall have the right to credit theremaining balance owed to MPI against the royalties and other payments payableto SBI under this License Agreement, and if this License Agreement terminatesor expires prior to SBI fully compensating MPI or SBI is no longer receivingroyalties or other payments under this License Agreement, such remainingbalances owed to MPI pursuant to this ***Article 7*** shall continue to be due andpayable in full.  Without in any waylimiting either Party’s indemnification obligations pursuant to this ***Article 7*** or anyother remedies a Party may have, if the other Party shall not fully compensatethe other Party as required pursuant to its indemnification obligationspursuant to this ***Article 7***,the Party shall pay the other Party interest to be computed for such unpaidamount on the last day of each calendar quarter (accruing quarterly) at theprime or other equivalent rate of Citibank for the last day of the calendarquarter plus **[***]**or the highest interest rate permissible under applicable law, whichever islower.

 

**7.5          Limits on Indemnification.**  Notwithstanding the general indemnificationprovisions at ***Section 7.1***or with respect to ***Section7.2*** of this License Agreement, the Parties have agreed toapportion their respective liabilities as follows:

 

**7.5.1      **SBI shall beresponsible for any Losses of MPI resulting from an act or omission of SBIcommitted prior to the Effective Date.

 

**7.5.2      **MPI shall be responsiblefor any Losses of SBI resulting from an act or omission of MPI, whethercommitted prior to or after the Effective Date (including, without limitation,any such Losses arising out of Third Party claims that MPI’s practice of theJoint Patent Rights infringes or misappropriates the intellectual propertyrights of such Third Party).

 

**7.6          Disclaimer Concerning Technology.**  Except as expressly provided in ***Article 6*** ofthis License Agreement, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTSPROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS,” AND EACH PARTY EXPRESSLYDISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDINGWITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR APARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADEPRACTICES, IN ALL CASES WITH RESPECT THERETO. Except as expressly provided in ***Article 6***, each Party disclaims anyimplied warranty as to the noninfringement of the intellectual property rightsof Third Parties.

 

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*****ConfidentialTreatment Requested**

 

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**7.7          DISCLAIMER.** EXCEPT AS PROVIDED IN THIS ***ARTICLE 7***, NEITHER PARTY SHALL BE LIABLE TOTHE OTHER UNDER THIS LICENSE AGREEMENT FOR ANY SPECIAL, CONSEQUENTIAL ORINCIDENTAL DAMAGES, INCLUDING ANY LOSS OF PROFITS OR LOSS OF ANY BUSINESSOPPORTUNITY.

 

**ARTICLE 8****NON-DISCLOSURE**

 

**8.1          Nondisclosure.**

 

**8.1.1      **During the term of thisAgreement and for seven (7) years thereafter without regard to the means oftermination, neither SBI nor MPI shall use, for any purpose other than thepurpose of this Agreement, reveal or disclose to any Third Party informationand materials disclosed by the other Party (whether prior to or during the termof this Agreement), and marked as confidential or which the receiving Partyknows or has reason to know are or contain trade secrets or other proprietaryinformation of the other Party, including information provided by a Party toanother Party prior to the Effective Date (***“Confidential Information”***) without first obtaining thewritten consent of the other Party, except (i) as may be required forsecuring Regulatory Approval, including pricing approval in the Territory or asmay otherwise be required to be disclosed to an Agency in the Territory; or (ii) asrequired by law or court order (subject to seeking confidential treatment whereavailable and prior notification to the disclosing Party); or (iii) asrequired in connection with any filings made with, or by the disclosurepolicies of a major stock exchange (subject to seeking confidential treatmentwhere available; or (iv) MPI shall have the right to provide ConfidentialInformation 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 ofthe License Agreement.  Thisconfidentiality obligation shall not (a) apply to such information whichis or becomes a matter of public knowledge; (b) is already in the possessionof the receiving Party (other than as a result of prior disclosure by thedisclosing Party pursuant to the Agreement); (c) is disclosednon-confidentially to the receiving Party by a Third Party having the right todo so; (d) is subsequently and independently developed by employees of thereceiving Party or Affiliates thereof who had no knowledge of the ConfidentialInformation disclosed.  The Partiesshall take reasonable measures to assure that no unauthorized use or disclosureis made by others to whom access to such information is granted.

 

**8.1.2      **MPI and SBI agree tolimit the disclosure of any Confidential Information received hereunder to suchof its employees and consultants and its Affiliates and with respect to SBI,SBI’s and its Affiliates’ sublicensees, distributors and partners ( and totheir potential sublicensees, distributors and partners) as are necessary tocarry out the provisions of this Agreement and who are likewise bound bywritten obligations of confidentiality which are comparable to, or morestringent than, the provisions of ***Section 8.1***.;

 

**8.2          Press Releases and PublicAnnouncements.**  It isunderstood that either Party may, subject to the terms and conditions of thisSection, issue a press release announcing the execution of this Agreement aswell as subsequent press releases relating to the Agreement or activitiesthereunder.  The Parties agree toconsult with each other reasonably and in good faith 

 

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with respect to the text and timing of such pressreleases prior to the issuance thereof. Either Party may issue such press releases (after providing three weeksadvance 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 orregulations or for appropriate market disclosure.  In addition, following the initial press release announcing thisAgreement, either Party shall be free to disclose, without the other Party’sprior written consent, the existence of this Agreement, the identity of theother Party and those terms of the Agreement which have already been publiclydisclosed in accordance herewith.

 

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

 

**ARTICLE 9****TRADEMARKS**

 

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

 

**ARTICLE 10****PATENTPROSECUTION AND MAINTENANCE**

 

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

 

**10.1.1    **MPI shall consult withSBI as to the preparation, filing, prosecution and maintenance of Joint PatentRights reasonably prior to any deadline or action with the U.S. Patent &Trademark Office or any foreign patent office, and shall furnish to SBI copiesof all relevant documents reasonably in advance of such consultation.  In the event that MPI desires to abandon anyJoint Patent Right, or if MPI later declines responsibility for any JointPatent Right, MPI shall provide reasonable prior written notice to SBI of suchintention to abandon or decline responsibility (which notice shall, in anyevent, be given no later than 60 days prior to the next deadline for anyaction 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 theright, at its expense, to prepare, file, prosecute, and maintain such JointPatent Right.  If SBI elects to prepare,file, prosecute, and maintain such Joint Patent Right, MPI shall cease to havean exclusive license to such Joint Patent Right under this Agreement, but eachParty shall continue to own its one-half undivided interest in such JointPatent Right.

 

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

 

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& Trademark Office or any foreign patent office,and shall furnish to MPI copies of all relevant documents reasonably in advanceof such consultation.  In the event thatSBI desires to abandon any SBI Patent Right, or if SBI later declinesresponsibility for any SBI Patent Right, SBI shall provide reasonable priorwritten 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 tothe next deadline for any action that may be taken with respect to such SBIPatent with the U.S. Patent & Trademark Office or any foreign patentoffice), and MPI shall have the right, at its expense, to prepare, file,prosecute, and maintain such SBI Patent Right.

 

**ARTICLE 11****INFRINGEMENTOF THIRD PARTY PATENTS; ENFORCEMENT**

 

**11.1        Enforcement of SBI Patent Rights andJoint Patent Rights.**

 

**11.1.1    **Upon learning of anyinfringement of an MPI Patent Right, SBI Patent Right or Joint Patent Right bya Third Party in the Territory, SBI or MPI, as the case may be, shall promptlyprovide notice to the other Party in writing of the fact and shall supply theother Party with all evidence possessed by the notifying Party pertaining tosaid infringement.

 

**11.1.2     MPIPatent Rights.** MPI shall have the first right to bring and control any action orproceeding with respect to infringement of any MPI Patent Right at its ownexpense and by counsel of its own choice. With respect to infringement of any MPI Patent Right that is likely tohave a material adverse effect on any Product being developed or commercializedby MPI, its Affiliates or its Sublicensees with respect to which SBI isentitled to royalty or other payments hereunder, SBI shall have the right, atits own expense, to be represented in any such action by counsel of its ownchoice, 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 theappropriate laws and regulations for the filing of such actions, whichevercomes first, SBI shall have the right to bring and control any such action atits 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 ownchoice.

 

**11.1.3     SBIPatent Rights.** SBI shall have the first right to bring and control any action orproceeding with respect to infringement of any SBI Patent Right at its ownexpense and by counsel of its own choice. With respect to infringement of any SBI Patent Right that is likely tohave a material adverse effect on any Product being developed or commercializedby MPI, its Affiliates or its Sublicensees, MPI shall have the right, at itsown 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 daysfollowing the notice of alleged infringement or (b) 10 days beforethe time limit, if any, set forth in the appropriate laws and regulations forthe filing of such actions, whichever comes first, MPI shall have the right tobring and control any such action at its own expense and by counsel of its ownchoice, and SBI shall have the right, at its own expense, to be represented inany such action by counsel of its own choice.

 

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

 

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expense and by counsel of its own choice, and SBIshall have the right, at its own expense, to be represented in any such actionby counsel of its own choice.  If MPIfails to bring an action or proceeding within (a) 60 days followingthe 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 ofsuch actions, whichever comes first, SBI shall have the right to bring andcontrol 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 suchaction by counsel of its own choice.

 

**11.1.5    **In the event a Partybrings an infringement action in accordance with this Section 11.1, the otherParty shall cooperate fully, including, if required to bring such action, thefurnishing of a power of attorney or being named as a party.  The Party controlling any such action maynot settle or consent to an adverse judgment without the express writtenconsent of the non-controlling Party (such consent not to be unreasonablywithheld or delayed).  Except asotherwise agreed to by the Parties as part of a cost-sharing arrangement, anyrecovery realized as a result of such litigation, after reimbursement of anylitigation expenses of MPI and SBI, shall be retained by the Party that broughtand controlled such litigation for purposes of this License Agreement, exceptthat any recovery realized by MPI as a result of such litigation, afterreimbursement of the Parties’ litigation expenses, shall, to the extentattributable to lost sales with respect to Products, be treated as Net Salesfor purposes of this License Agreement.

 

**11.2        Infringement of Third Party Rights. **Each Party shall promptlynotify the other in writing of any allegation by a Third Party that theactivity of either of the Parties pursuant to this License Agreement infringesor may infringe the intellectual property rights of such Third Party.  MPI shall have the sole right to control anydefense of any such claim involving alleged infringement of Third Party rightsby MPI’s activities at its own expense and by counsel of its own choice, andSBI shall have the right, at its own expense, to be represented in any suchaction by counsel of its own choice. SBI shall have the sole right to control any defense of any such claiminvolving alleged infringement of Third Party rights by SBI’s activities at itsown expense and by counsel of its own choice, and MPI shall have the right, atits own expense, to be represented in any such action by counsel of its ownchoice.  Neither Party shall have theright to settle any patent infringement litigation under this Section 11.2in a manner that diminishes the rights or interests of the other Party withoutthe written consent of such other Party (which shall not be unreasonablywithheld or delayed).

 

**ARTICLE 12****TERMINATION**

 

**12.1        Early Termination.**

 

**12.1.1    **If MPI commits a materialbreach of any material term or condition of this License Agreement solely as a resultof MPI’s failure to pay SBI amounts owed to SBI (providedthatneither the amount or the obligation to pay such amount is in dispute betweenthe Parties), and MPI fails to cure such breach within thirty (30) days afterreceiving written notice of the breach from SBI, SBI shall have the right toterminate this License Agreement upon written notice to MPI at the end of suchthirty (30) day period for MPI’s uncured breach.  In the event of any dispute as to any amount payable to SBI, MPIshall pay the full amount not in dispute and

 

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the dispute regarding the remaining amount shall besubmitted to arbitration pursuant to ***Section 14.5***.

 

**12.1.2    **If either Party commits amaterial 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 givethe other Party written notice of the breach, and if the breach is not curedwithin sixty (60) days after receiving written notice of the breach, thenon-breaching Party shall have the right to submit the matter to arbitrationpursuant to ***Section 14.5***for resolution within thirty (30) days of the end of such sixty (60) day periodby giving the other Party written notice requesting arbitration within suchthirty (30) day period.  The Partiesshall continue to perform their obligations hereunder during the pendency ofsuch arbitration, except to the extent mutually agreed otherwise by the Partiesor except as directed by the arbitrators. The arbitrators’ decision shall be binding upon the Parties except thatin no event shall the arbitrators have the power or authority to terminate thisLicense 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 tohave the right, itself and/or through or with its Affiliates or any of theirdesignees, to develop, have developed, make, have made, use, distribute, offerfor sale, import, export and sell Products in such country or countries withrespect to which this License Agreement has expired and shall have a fullypaid-up, non-exclusive, irrevocable license in such countries under the rightslicensed to MPI pursuant to ***Article 2***.

 

**13.2        Effect of Expiration or Termination.**  Except as otherwise expressly set forth inthis License Agreement, upon expiration or termination of this LicenseAgreement, all rights, licenses, properties and interests granted by each Partyto the other Party shall immediately revert to and become fully vested in thegranting Party, and the other Party shall return to it all documents and anyConfidential Information supplied to it or its Affiliates by the other Party.  Without limiting the generality of theforegoing, each Party will have the right to practice the Joint Patent Rightswithout the consent of, or any obligation to account to, the other Party forsuch practice.

 

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

 

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

 

**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 LicenseAgreement, 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 orexternally induced casualty beyond its reasonable control, whether similar tothe foregoing matters or not, then, upon written notice by the Party liable toperform to the other Party, the requirements of this License Agreement or suchof its provisions as may be affected, and to the extent so affected, shall besuspended during the period of such disability.

 

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

 

**14.3        Notices.**  Any notices required or permitted to begiven hereunder shall be in writing in the English language and shall bedelivered in person or by DHL, Federal Express (or other courier servicerequiring signature upon receipt) or sent by air mail, postage prepaid, orfacsimile (confirmed by a telephone conversation with the recipient) to theaddresses set forth below.  The Partiesmay change the address at which notice is to be given by giving notice to theother Party as herein provided.  Allnotices shall be deemed effective upon receipt by the Party to whom it isaddressed.

 

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If to MPI:

 

Maxim Pharmaceuticals,Inc.

8899 University CenterLane

Suite 400

San Diego, California92122

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 accordancewith the laws of the State of New York, the United States of America, otherthan its conflict of law rules except for Section 5-1401 of the New YorkGeneral Obligations Law.  The Partiesexpressly exclude any application of the United Nations Convention on Contractfor the Sale of Goods to this License Agreement.

 

**14.5        Dispute Resolution.**

 

**14.5.1    **The Parties shallinitially attempt in good faith and best efforts to resolve any significantcontroversy, claim, or dispute arising out of or relating to this LicenseAgreement or any significant breach thereof (hereinafter collectively referredto as a ***“Dispute”***)through face-to-face negotiations between the Senior Executive Officers of SBIand MPI.  If the Dispute is not resolvedwithin thirty (30) days (or such other period of time mutually agreed upon bythe Parties) of commencing such face-to-face negotiations, or if the Partyagainst which a claim has been asserted refuses to attend such negotiations ordoes not otherwise participate in such negotiations within thirty (30) days (orsuch other period of time mutually agreed upon by the Parties) from the date ofnotice of a Dispute, then the Parties agree to mediation with a mutually agreedmediator.  If the mediation of suchDispute does not commence within thirty (30) days (or such other period of timemutually agreed upon by the Parties) of the end of such face-to-facenegotiations, or if the Dispute is not resolved within thirty (30) days (orsuch other period of time mutually agreed upon by the Parties) of commencingsuch mediation, or if the Party against which a claim has been asserted refusesto attend either face-to-face negotiations or such mediation, or the Partiesare unable to agree upon a mediator, then the Parties agree to submit theDispute to arbitration as provided herein. Unless otherwise mutually agreed by the Parties, only if the Dispute isnot resolved through face-to-face negotiations or mediation as set forth abovein this Section 14.5, may a Party resort to arbitration.

 

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**14.5.2    **Except as provided inthis Section 14.5, all Disputes relating in any way to this LicenseAgreement shall be resolved exclusively through arbitration conducted under theauspices of the Center for Public Resources (“CPR”) pursuant to CPR’s Model ADRProcedure: Non-Administered International Arbitration Rules andCommentary.  The arbitration shall beconducted in the English language before three (3) arbitrators, one selected byeach Party and the third to be selected by the other two.  Unless otherwise mutually agreed by theParties, any arbitration brought hereunder shall be brought only andexclusively in New York, New York.  Thearbitrators shall hear evidence by each Party and resolve each of the issuesidentified by the Parties.  Thearbitrators shall render a formal, binding non-appealable resolution and awardon each issue as expeditiously as possible, but not more than fifteen (15)business days after the hearing.  In anyarbitration, the prevailing Party shall be entitled to reimbursement of itsreasonable attorneys’ fees and the Parties shall use all reasonable efforts tokeep arbitration costs to a minimum.

 

**14.5.3    **In no event shall thearbitrators have the power or authority to terminate this License Agreement inwhole or in part.

 

**14.5.4    **Nothing in this LicenseAgreement shall be deemed as preventing either Party from seeking injunctiverelief (or any other provisional remedy) from any court having jurisdictionover the Parties and the subject matter of the dispute as necessary to protect eitherParty’s intellectual property.

 

**14.6        Interpretation.**  This License Agreement is executed in theEnglish language.  This LicenseAgreement shall be deemed to comprise the language mutually chosen by theParties, has been prepared jointly and no rule of strict construction shall beapplied against either Party.  In thisLicense Agreement, the singular shall include the plural and *vice versa*and the word “including” shall be deemed to be followed by the phrase “withoutlimitation”.  *Lesparties reconnaissent leur volonté expresse que la présente convention ainsique tous les documents et conventions qui s’y rattachent directment ouindirectment soient rédigés en langue anglaise.*

 

**14.7        Severability.**  In the event that any provision of thisLicense Agreement shall be held to be unenforceable, invalid or incontravention of applicable law, such provision shall be of no effect, and theParties shall negotiate in good faith to replace such provision with aprovision which effects to the extent possible the original intent of suchprovision.

 

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

 

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

 

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

 

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

 

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

 

**14.12      Rights in Bankruptcy. **All rights and licensesgranted under or pursuant to this License Agreement by a Party (the ***“Grantor”***) are, andwill 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 underSection 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 mayfully exercise all of its rights and elections under the U.S. BankruptcyCode.  The Parties further agree that,in the event of the commencement of a bankruptcy proceeding by or against theGrantor under the U.S. Bankruptcy Code, the Grantee will be entitled to acomplete duplicate of (or complete access to, as appropriate) any suchintellectual property and all embodiments of such intellectual property, andsame, if not already in its possession, will be promptly delivered to it(i) upon any such commencement of a bankruptcy proceeding upon its writtenrequest therefor, unless the Grantor elects to continue to perform all of itsobligations under this License Agreement, or (ii) if not delivered under(i) above, following the rejection of this License Agreement by or on behalf ofthe Grantor upon written request therefor by the Grantee.

 

**14.13      Counterparts.**  The Agreement may be executed simultaneouslyin one or more counterparts, each one of which need not contain the signatureof more than one Party but such counterparts taken together shall constituteone and the same agreement.

 

**14.14      IN WITNESS WHEREOF**, theParties have executed this License Agreement as of the date first abovewritten.

 
| **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 (5pages)

 

**[***]**

 
| MPI’s Intitials:  DAS          |
|------------------------------------------|
| SBI’s Initials:  RB            |
|                                          |
| *****Confidential  Treatment Requested** |

 

----

 

**EXHIBIT B**

** **

**MPI PATENT RIGHTS**

** **

See attached document (1page)

 

**[***]**

 
| MPI’s Intitials:  DAS          |
|------------------------------------------|
| SBI’s Initials:  RB            |
|                                          |
| *****Confidential  Treatment Requested** |

 

----

 

**EXHIBIT C**

** **

**PRODUCT**

** **

The ***“Product”*****means any member of the class ofsubstituted 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** |

 

----