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Exhibit 10.1
 EXECUTION COPY
 ELAN PHARMA INTERNATIONAL
LIMITED
 AND
 ENTREMED, INC.
 
 LICENSE AGREEMENT




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INDEX
 1.
    
    Definitions and Interpretation
    
    
    12.
    
    The License
    
    
    73.
    
    Intellectual Property
    
    
    84.
    
    Non-Competition
    
    
    155.
    
    Registration, Marketing and the Promotion of the Product
    
    
    156.
    
    Financial Provisions
    
    
    157.
    
    Manufacture and Supply
    
    
    188.
    
    Payments, Reports and Audits
    
    
    199.
    
    Duration and Termination
    
    
    1910.
    
    Consequences of Termination
    
    
    2111.
    
    Warranties, Indemnification and Liability
    
    
    2212.
    
    Confidentiality
    
    
    2513.
    
    Miscellaneous Provisions
    
    
    26Schedule 1
    
    EPIL Patents
    
    
    31Schedule 2
    
    EntreMed Patents
    
    
    39Schedule 3
    
    Technological Competitors
    
    
    40Schedule 4
    
    Commercial Unit Dose Cost of Goods Pricing
    
    
    41Schedule 5
    
    Key Terms for Manufacturing and Supply Agreement
    
    
    42i




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THIS LICENSE AGREEMENT
 PARTIES:
 (1)
    
    ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated under the laws of Ireland, having
its registered office at Monksland, Athlone, Co Westmeath, Ireland (EPIL); and(2)
    
    ENTREMED, INC., a Delaware corporation, having its principal place of business at 9640
Medical Center Drive, Rockville, MD 20850 (EntreMed).
 BACKGROUND:
 (A)
    
    EPIL possesses certain proprietary technology as well as proprietary know-how and
confidential information used or useful in the manufacture and use of pharmaceutical products
containing nanoparticles.(B)
    
    EntreMed possesses certain rights to intellectual property rights covering the Compound (as
defined below).(C)
    
    EntreMed wishes to obtain the right to utilize certain EPIL Intellectual Property to
commercialize the Product in the Field in the Territory in accordance with the terms and
conditions set out below.(D)
    
    Simultaneously with or shortly after the execution of this Agreement, EntreMed intends to
enter into a Services Agreement with EDDI, an EPIL Affiliate, that will contain a Development
Plan for further research and development of the Product and that will grant EDDI the
exclusive right to supply the Product to EntreMed for preclinical, clinical and regulatory
purposes.(E)
    
    Following the execution of this Agreement and the Services Agreement, EPIL and EntreMed
intend to enter into a Manufacturing and Supply Agreement that will establish the terms by
which EPIL or an Affiliate will manufacture and supply to EntreMed its entire requirement of
the Product for commercial supply in the Territory.
 TERMS:
  1.
    
    DEFINITIONS AND INTERPRETATION1.1.
    
    Definitions. In this Agreement:Affiliate means any corporation or entity controlling, controlled or under common control
with EPIL or EntreMed, as the case may be. For the purposes of this Agreement, control
means the direct or indirect ownership of more than 50% of the issued voting shares or other
voting rights of the subject entity to elect directors, or if not meeting the preceding
criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted
in the country where such entity exists.
 
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Agreement means this license agreement (which expression shall be deemed to include its
Recitals and Schedules).API means active pharmaceutical ingredient.Business Days means Monday to Friday inclusive, excluding any days on which the clearing
banks are generally closed in Dublin and/or New York.cGMP means the then current regulations set forth in 21 C.F.R. Parts 210-211, 820 or 21
C.F.R. Subchapter C (drugs) quality system regulations and the requirements thereunder
imposed by the FDA and, as applicable, the equivalent regulations and requirements imposed
by other RHAs in the Territory.Claims means all and any claims (whether successful or otherwise), demands, settlement
amounts, losses, liabilities, damages, costs and expenses, including reasonable attorneys
fees and expenses and legal costs.Commercially Reasonable Efforts means those efforts of a party which are consistent with
those utilised by such party for its own internally developed or in-licensed pharmaceutical
products, taking into account all factors that impact the manufacturing, development,
marketing and sales of such products, as applicable.Compound means EntreMeds proprietary compound 2-methoxyestradiol (2ME2) having
the following chemical formula:(COMPOUND CHEMICAL FORMULA)For the avoidance of doubt, Compound does not include any analogs or derivatives of 2ME2
including, but not limited to, EntreMed compound ENMD-1198.Compound Data means data relating to the Compound generated by EntreMed or EDDI
pursuant to the Services Agreement and/or Development Plan.CSA means the Clinical Supply Agreement dated July 12, 2004, as amended, entered into by
EntreMed and EDDI including all of its appendices, schedules and exhibits thereto related to
the Compound.DDP (delivery duty paid) shall have the same meaning as in the ICC Incoterms 2000,
International Rules for the Interpretation of Trade Terms, ICC Publications No. 560.Development Plan shall have the meaning ascribed thereto in the Services Agreement.DMF or Drug Master File means any confidential detailed information submitted by EPIL,
EDDI or its Affiliates to any RHA in the Territory about any facilities, processes or
articles that
 
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are used by EPIL, EDDI or its Affiliates in the manufacture, processing, packaging or
storage of the Product.EDDI means EPILs Affiliate, Elan Drug Delivery, Inc., a Delaware Corporation, having its
principal place of business at 3000 Horizon Drive, King of Prussia, PA 19406.EEA means the member states of the European Economic Area, as the same may change from
time to time.Effective Date means the date of this Agreement as set forth in the header on page 1
herein.EntreMed Improvements means any and all improvements under the EntreMed Patents, the
EntreMed Know-How and/or to the Compound that have been conceived, created, developed and/or
otherwise invented by EntreMed or its Affiliates and/or EPIL or its Affiliates and such
Parties Third Party contractors under the Services Agreement, or otherwise pursuant to this
Agreement, the Manufacture and Supply Agreement, the CSA, the MEEA or the Letter Agreement.EntreMed Intellectual Property means the EntreMed Know-How, the EntreMed Patents and the
EntreMed Improvements and the Compound.EntreMed Know-How means any and all rights owned, licensed or controlled by EntreMed or
its Affiliates as of the Effective Date (otherwise than pursuant to the EPIL License) to any
scientific, pharmaceutical or technical information, data, discovery, invention (whether
patentable or not), know-how, substances, techniques, processes, systems, formulations and
designs and expertise relating to the Compound which is not generally known to the public.EntreMed Patents means any and all rights under any and all patent applications and/or
patents, now existing, currently pending or hereafter filed, or acquired or licensed by
EntreMed or its Affiliates relating to the Compound, including without limitation as set
forth in Schedule 2, and any foreign counterparts thereof and all divisionals,
continuations, continuations-in-part, any foreign counterparts thereof and all patents
issuing on any of the foregoing and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, supplemental protection certificates, or
extensions thereof, and any foreign counterparts thereof.EntreMed Trademark means EntreMeds
rights to use the trademark(s) Panzem® or such other
trademarks as EntreMed may from time to time reasonably specify.EPIL Improvements means
* any and all improvements to the EPIL Patents, the EPIL
Know-How, the EPIL Technology
* that have been conceived, created, developed and/or
otherwise invented by EPIL or its Affiliates and/or EntreMed or its Affiliates and such
Parties Third Party contractors under the Services Agreement, or otherwise pursuant to this
Agreement, the Manufacture and Supply Agreement, the CSA, the MEEA or the Letter Agreement.EPIL Intellectual Property means the EPIL Know-How, the EPIL Patents and the EPIL
Improvements.EPIL Know-How means any and all rights owned, licensed or controlled by EPIL or its
Affiliates as of the Effective Date to any scientific, pharmaceutical or technical
information, data, discovery, invention (whether patentable or not), know-how, substances,
techniques, processes,
 
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systems, formulations, designs and expertise relating to the EPIL Technology which is not
generally known to the public.EPIL Patents means any and all rights under any and all patent applications and/or
patents, now existing, currently pending or hereafter filed by EPIL relating to the EPIL
Technology, including without limitation as set forth in Schedule 1, and any foreign
counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign
counterparts thereof and all patents issuing on any of the foregoing, and any foreign
counterparts thereof, together with all registrations, reissues, re-examinations,
supplemental protection certificates, or extensions thereof, and any foreign counterparts
thereof.EPIL Technology means EPILs proprietary technology directed to:(a) nanoparticulate colloidal dispersions of compounds stabilized against agglomeration of
the nanoparticles and EPILs proprietary methods, equipment and materials used for making
such dispersions (such technology is commonly referred to by EPIL as NanoCrystal®
Technology); and(b) EPILs proprietary processes for converting said dispersions into intermediates and/or
finished tablet or capsule formulations and the intermediates, tablets and capsules created
using such proprietary processes including the NanoMill® System; andas more fully described in the EPIL Patents and applied in the EPIL Know-How.EPIL Trademark means NanoCrystal®, NanoMill® or such other
trademarks as EPIL may from time to time reasonably specify.EU means the member states of the European Union, as same may change from time to time in
terms of member states.EXW (ex works) has the same meaning as in the ICC Incoterms 2000, International Rules for
the Interpretation of Trade Terms, ICC Publication No. 560.FDA means the United States Food and Drug Administration or any other successor agency
whose approval is necessary to market the Product in the US.Field means oral prescription pharmaceutical products for use in humans. Diagnostics
are specifically excluded.Force Majeure means any cause or condition beyond the reasonable control of the Party
obliged to perform, including acts of God, acts of government (in particular with respect to
the refusal to issue necessary import or export licenses), fire, flood, earthquake, war,
riots or embargoes or strikes affecting a Party.Generic means each generic version of Product that is legally substitutable for the
Product as follows: (i) in the US, is approved under 21 U.S.C. 505(j) (or any successor
legislation) or which has an AB rating with respect to Product; (ii) in the EU, is
authorised to be placed on the market in accordance with Article 10 of Directive 2001/83/EC
as amended (when implemented by such member states) by Directive 2004/27 (or any successor
legislation); (iii) in countries of the Territory other than the US and the EU where such
pharmaceutical product: (a) contains the same active pharmaceutical ingredients as Product;
(b) is approved by an abridged procedure that
 
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relies in whole or in part on safety and efficacy data generated for any approval of
Product; and (c) has the same or substantially the same labelling as the Product.Governmental Authority means all governmental and regulatory bodies, agencies, departments
or entities, which regulate, direct or control commercial and other related activities in
the Territory.Highly Confidential Informationshall have the meaning ascribed thereto in the Services
Agreement.ICHmeans the International Conference on Harmonization.ICH Qualifying Batch means batches of Product intended for stability studies to support
registration of the first commercial Product in the Territory.In Market means the sale of the Product in the Territory by EntreMed, or where applicable,
by a permitted sub-licensee, to an unaffiliated Third Party, such as a wholesaler,
distributor, managed care organisation, hospital or pharmacy, and shall exclude the transfer
pricing of the Product by one EntreMed Affiliate to another EntreMed Affiliate or a
permitted sub-licensee.Letter Agreement means the letter agreement entered into by EntreMed and EPIL dated
May 9, 2005.Manufacturing and Supply Agreement means the agreement that will be entered into by
EntreMed and EPIL or its Affiliate, for the manufacture and supply of Product in the Field
in the Territory by EPIL or its Affiliate to EntreMed.MEEA means the Master Experimental Evaluation Agreement dated May 18, 2004 entered into by
EntreMed and EDDI including all of its appendices, schedules and exhibits thereto related to
the Compound.*                NanoMill® Systemmeans the milling system designed and developed by or on behalf of EPIL
and its Affiliates for preparing nanoparticulate dispersions for pharmaceutical
formulations, including the milling equipment and appropriate milling media and stabilizing
materials, and associated manuals, protocols and know-how.NCDmeans NanoCrystal® colloidal dispersion.Net Sales shall, subject to the provisions of Clause 6.7, mean in the case of Product sold
by EntreMed, or by a sub-licensee, the aggregate gross In Market sales proceeds billed for
the Product by EntreMed, or by a sub-licensee, as the case may be, in accordance with
generally accepted accounting principles, less the following deductions relating to such
sales, provided that all such deductions shall be commercially reasonable and consistent
with standard industry practices and are actually paid and not recouped:
 (i)
    
    trade, cash or quantity discounts, allowances, adjustments and rejections, and
any other adjustments, including those granted on account of price adjustments, billing
errors, rebates, chargeback rebates, fees, reimbursements or similar payments granted
or given to
 
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wholesalers or other distributors, buying groups, health care insurance carriers or
other institutions;(ii)
    
    rebates, recalls (other than where the Product is replaced without charge),
returns, rejected goods and damages goods not covered by insurance;(iii)
    
    price reductions or rebates imposed by Governmental Authorities and any
payment in respect of sales to any Governmental Authority in respect of any
government-subsidized program, including Medicare and Medicaid rebates or other
payments under managed care agreements;(iv)
    
    sales, excise, turnover, inventory, value-added and similar taxes assessed on
the royalty-bearing sale of such Product, but not including any taxes on income paid by
or assessed against EntreMed or a sub-licensee;(v)
    
    transportation, importation, shipping, insurance and other handling expenses
directly chargeable to the royalty-bearing sale of the Product, but only to the extent
that such expenses are separately delineated in the applicable invoices;(vi)
    
    chargebacks granted to drug wholesalers or their customers in cases where there
are not direct shipments to such customers by EntreMed or its sublicense.
 For the avoidance of doubt, costs associated with changes to packaging or labelling shall
not be deducted from Net Sales.Party or Parties means EPIL and its Affiliates or EntreMed or its Affiliates,
individually or collectively, as referred to herein.Pivotal Study means a clinical study whose primary objective is to obtain a definitive
evaluation of the therapeutic efficacy and safety of the Product in patients for the
particular indication in question.Post-Phase 1b Clinical Study in this Agreement means any clinical study initiated post
phase I.Product means liquid, tablet or capsule formulations for oral administration being
developed pursuant to the Development Plan that incorporate the EPIL Technology and contain
the Compound as the sole active ingredient. For the avoidance of doubt, injectable
formulations are specifically excluded from this Agreement.Prosecute means in relation to a class of intellectual property:
 (a)
    
    to secure the grant of any patent application within such class;(b)
    
    to file and prosecute patent applications on patentable inventions and
discoveries relating to that class;(c)
    
    to defend all such applications against Third Party oppositions; and(d)
    
    to maintain in force any issued letters patent relating to the same
 
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and Prosecution has a corresponding meaning.Regulatory Application means any regulatory application or any other application for
marketing approval for the Product, which EntreMed will file with the FDA or with any other
RHA in the Territory, including any supplements or amendments thereto which EntreMed may
file.Regulatory Approval means the final approval to market the Product in any country of the
Territory, including pricing and reimbursement approval and any other approval which is
required to launch the Product in the normal course of business.RHA means any relevant government health authority (or any successor agency thereof) in
any country of the Territory, including the FDA, whose approval is necessary to market and
sell the Product in the relevant country of the Territory.Related Agreements means the Services Agreement and the Manufacturing and Supply
Agreement.Services Agreement means the agreement, and all appendices, schedules, exhibits and
amendments thereto, between EntreMed and EDDI that is signed simultaneously with this
Agreement, or shortly thereafter, and that contains a Development Plan for EDDI to perform
certain development activities for the formulation of the Product and such other services as
may be agreed by the Parties.Technological Competitor means a person or entity listed in Schedule 3, and divisions,
subsidiaries and successors thereof *. For this definition competitors shall
mean companies that have or use technology that is directed to and/or suitable for providing
substantially similar or comparable enhancements to the solubility characteristics of active
pharmaceutical ingredients as those provided by EPIL Technology.Term means the term of this Agreement, as set out in Clause 9.3 herein.Territory means all of the countries of the world.Third Party means any individual or entity not a Party to this Agreement other than an
Affiliate of a Party.US or USA means the United States of America and its possessions and territories,
including but not limited to Puerto Rico.Valid Claimmeans any claim of an issued and unexpired patent included within the EPIL
Intellectual Property which has not been held unenforceable, unpatentable or invalid by a
decision of a court or government agency of competent jurisdiction, that is unappealable or
unappealed within the time allowed for appeal, or which has not expressly been admitted by
the holder of the patent or supplementary protection certification to any person to be
invalid or unenforceable.VAT or Value Added Tax means (i) any tax imposed in compliance with the Sixth Directive
of the Council of the European Communities (77/388/EEC) and (ii) any other tax of a similar
 
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fiscal nature, whether imposed in a member state of the European Union or anywhere else in
the Territory.$ and US$ mean US Dollars.1.2.
    
    Further Definitions. In addition, the following definitions have the meanings in the
Clauses corresponding thereto, as set forth below:
 Definition
    
    ClauseCompensation Fee
    
    6.2Confidential Information
    
    12.1Designated Manufacturer
    
    7.3Disclosing Party
    
    12.14Due Date
    
    8.8EntreMed Logo
    
    3.6.1.2EPIL License
    
    2.1Extended Term
    
    9.2Firm
    
    3.5.5Infringement Claim
    
    3.4.1Initial Term
    
    9.1License Milestone Payments
    
    6.1Manufacturing License
    
    7.3Notice
    
    13.11.1Statement
    
    8.1Quality Agreement
    
    Schedule 5, paragraph 4
 1.3.
    
    Interpretation. In this Agreement:
 1.3.1
    
    the singular includes the plural and vice versa, and unless the context or
subject otherwise requires, references to words in one gender include references to the
other genders;1.3.2
    
    unless the context otherwise requires, reference to a recital, article,
paragraph, provision, clause or schedule is to a recital, article, paragraph,
provision, clause or schedule of or to this Agreement;1.3.3
    
    the headings in this Agreement are inserted for convenience only and do not
affect its construction; and1.3.4
    
    the expressions include, includes, including, in particular and
similar expressions shall be construed without limitation.
 2.
    
    THE LICENSE2.1.
    
    EPIL License to EntreMed. Subject to the terms of this Agreement, EPIL hereby grants
to EntreMed an exclusive license (the EPIL License) to the EPIL Intellectual Property to
import, export, use, conduct clinical evaluations in support of Regulatory Applications, offer
for sale, market, distribute and sell the Product in the Field in the
Territory, subject
to*.
For the avoidance of doubt, the EPIL License shall not include the right to
perform any
 
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formulation and/or process development activities for the Product unless this has been
agreed pursuant to the Services Agreement.2.2.
    
    Sub-licensing. Subject to the prior written consent of EPIL which shall not be
unreasonably withheld, delayed or conditioned, EPIL grants to EntreMed the right to grant
sub-licenses in respect of the EPIL Intellectual Property to import, export, use, offer for
sale, market, distribute and sell the Product in one or more countries of the Territory,
subject to the following conditions:
 2.2.1
    
    Any sub-license granted shall be in the same terms as the terms of this
Agreement insofar as they are applicable, mutatis mutandis, but excluding the right to
grant a sub-license;2.2.2
    
    For the avoidance of doubt, EntreMed shall ensure that EPIL shall have the
same rights of audit and inspection vis-à-vis a sub-licensee as EPIL has vis-à-vis
EntreMed pursuant to this Agreement.2.2.3
    
    EntreMed shall be liable to EPIL and its Affiliates for all acts and omissions
of any sub-licensee as though such acts and omissions were by EntreMed.2.2.4
    
    EntreMed shall not disclose any Confidential Information of EPIL or its
Affiliates in its dealings with sublicensees without the prior written consent of EPIL,
which consent shall not be unreasonably withheld or delayed.*
 3.
    
    INTELLECTUAL PROPERTY3.1.
    
    Ownership of Intellectual Property.
 3.1.1
    
    EPIL shall remain the sole owner of the EPIL Intellectual Property.3.1.2
    
    EntreMed shall remain the sole owner of the EntreMed Intellectual Property.
 3.2.
    
    Patent Prosecution and Maintenance.
 3.2.1
    
    EPIL, at its sole discretion and expense, may Prosecute the EPIL Intellectual
Property in the Territory.3.2.2
    
    EntreMed, at its sole discretion and expense, may Prosecute the EntreMed
Intellectual Property in the Territory.3.2.3
    
    Each Party shall provide the other with reasonable support in the Prosecution
of the EPIL Intellectual Property and the EntreMed Intellectual Property in respect of
any inventions that were developed under this Agreement or Related Agreements and shall
provide all information and/or data in its possession that is reasonably necessary or
proper to support any relevant patent application in the Territory. Further, the
Parties shall execute and deliver all documents and instruments that are reasonably
necessary or proper to support the Prosecution of the EPIL Intellectual Property and
the EntreMed Intellectual Property as the other Party may request.
 
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3.3.
    
    Enforcement.
 3.3.1
    
    EPIL and EntreMed shall promptly inform each other in writing of any actual or
alleged unauthorized use of the EPIL Intellectual Property or the EntreMed Intellectual
Property by a Third Party of which it becomes aware and provide the other Party with
any available evidence of such unauthorized use.3.3.2
    
    EPIL shall have the right to enforce for EPILs own benefit (including by
agreement or by litigation) EPIL Intellectual Property at its own instigation.
EntreMed shall reasonably cooperate with EPIL to enforce such rights. In the event
such proceedings are related to the Product, EntreMed shall be kept advised at all
times of such suit or proceedings brought by EPIL.3.3.3
    
    EntreMed shall have the right to enforce for EntreMeds own benefit (including
by agreement or through litigation) EntreMed Intellectual Property at its own
instigation. EPIL shall reasonably cooperate with EntreMed to enforce such rights. In
the event such proceedings are related to the Compound, EPIL shall be kept advised at
all times of such suit or proceedings brought by EntreMed.
 3.4.
    
    Infringement Claims.
 3.4.1
    
    Each of the Parties shall promptly notify the other Party in
writing of any Claims made or brought against either of them alleging
infringement or other unauthorised use of the proprietary rights of a Third
Party arising from the manufacture, importation, use, offer for sale, sale or
other commercialization of the Product in the Territory (Infringement Claim).3.4.2.
    
    EntreMed shall indemnify and hold harmless Elan against all Infringement
Claims related to the manufacture, importation, use, offer for sale, sale or
other commercialization of the Product in the Territory resulting from:
 3.4.2.1
    
    a breach by EntreMed of its representations and warranties set forth
in Clauses 11.2.3 to 11.2.6; or3.4.2.2
    
    intellectual property which is owned by, licensed to (which for
clarity does not include the EPIL License which is governed pursuant to
other terms and conditions contained in this Agreement) or controlled
by EntreMed, any Affiliate of EntreMed or a permitted sub-licensee in
the country in question, or which is/was generated pursuant to some
agreement between EntreMed (or an Affiliate or permitted sub-licensee)
on the one hand and a Third Party on the other.
 3.4.3
    
    Subject to Clauses 3.4.4, 3.4.5 and 3.4.6, EPIL shall
indemnify and hold harmless EntreMed against all Infringement Claims resulting
from a breach by EPIL of its representations and warranties set forth in
Clauses
*               ..For the avoidance of doubt, the parties agree that EntreMed shall indemnify
and hold harmless EPIL against all claims (whether successful or otherwise),
demands, settlement amounts, damages, losses, liabilities, costs and
expenses
 
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(including reasonable attorneys fees) which may arise in connection with any
Infringement Claim related to the manufacture, importation, use, offer for
sale, sale or other commercialization of the Product in the Territory where
such Infringement Claim does not result from a breach by EPIL of any of its
representations or warranties set forth in Clauses
* ..3.4.4
    
    Subject to Clause 3.4.5 and Clause 3.4.6, EPILs aggregate
cumulative liability pursuant to Clause 3.4.3 (and/or under any other provision
of this Agreement) in respect of those Infringement Claims for which EPIL is
liable under Clause 3.4.3 shall not exceed certain limitations as follows:
 3.4.4.1
    
    *% (* per cent)of any lump sum payment due
to a Third Party as a result of a court order or settlement in respect
of the Infringement Claim (including a claim for damages); and3.4.4.2
    
    *% (* per cent) of any license fees due
to a Third Party under any license entered into in accordance with
Clause 3.5 (or as applicable, payments in the nature of a royalty on
sales ordered to be paid to such Third Party by a court of competent
jurisdiction in a final judgment under such an Infringement Claim).
 3.4.5
    
    EntreMed will be entitled to recover amounts due by EPIL to
EntreMed under Clause 3.4.4 as a credit against the sums payable by EntreMed to
EPIL under the provisions of Clause 6 during the Initial Term, provided however
that the maximum credit which may be claimed by EntreMed will be *% (* per cent) of the sums otherwise payable in that
quarter.Any deficit remaining in EntreMeds recovery of amounts due by EPIL to
EntreMed under Clauses 3.4.3 and 3.4.4 following recovery by EntreMed within
the limitations set forth in this Clause 3.4.5 may be carried over to
subsequent calendar quarters, subject always to the preceding paragraph. Any
deficit at the end of the Initial Term shall be borne by EntreMed and EPIL
shall have no liability to EntreMed in relation thereto.For the avoidance of doubt, EntreMed shall indemnify and hold harmless EPIL
against all Infringement Claims to the extent that they are in excess of the
limits set forth in Clause 3.4.4 and this Clause 3.4.5.3.4.6
    
    The Parties hereby agree that EntreMed shall consult with EPIL
prior to making references to EPIL Intellectual Property in any proceedings and
obtain EPILs permission to make such references, except to the extent required
by applicable law. Save as specifically provided otherwise in this Clause 3.4,
the provisions of Clause 11.7 shall apply as regards the conduct of any
Infringement Claim.With reference to the provisions of Clause 11.7.4, EPIL and EntreMed shall
consult as regards any actions EPIL or EntreMed proposes to take in order to
mitigate any loss or liability in respect of any Infringement Claim, such as
EntreMed ceasing to sell the Product, the Parties agreeing to modify the
Product, or either or both of the Parties entering into a licensing or
settlement negotiation with the Third Party.
 
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In the event that the Parties are unable to agree on such action, (1)
* and (2) EntreMed shall be entitled to take such action as it may
reasonably consider expedient pursuant to the terms as set forth in Clause
3.5 herein. In the event that EntreMed fails to take such action as
reasonably requested by EPIL, EntreMed shall indemnify and hold EPIL
harmless against all Infringement Claims as they related to the manufacture,
* of the Product in the Territory to the extent that they relate to
the period after the date of the direction to take such action.
 3.5.
    
    Third Party Licenses.
 3.5.1
    
    Notice. If EntreMed reasonably believes that the sale of Products
would infringe the intellectual property rights of a Third Party unless a license is
obtained from such Third Party, and that such infringement arises as a result of the
incorporation of the EPIL Technology into the Product, EntreMed shall so inform EPIL by
written notice, which shall include documents supporting EntreMeds position and shall
notify EPIL that it has thirty (30) days in which to respond.3.5.2
    
    Counter-Notice. EPIL shall have thirty (30) days to review the notice
from EntreMed and to agree or disagree with EntreMeds belief by written
counter-notice. If EPIL disagrees with EntreMeds belief, then EPIL shall provide
EntreMed with documents supporting EPILs position. EntreMed shall have thirty (30)
days from the date of receipt to review the documents from EPIL. Failure by EPIL to
respond to EntreMeds notice, or by EntreMed to respond to EPILs notice, shall be
taken for the purposes of the decision as to whether to obtain a license under this
Clause 3.5 (but for the avoidance of doubt, not for any other purpose whatsoever) as
accession to the position of the other Party. The Parties agree that the time periods
as set forth in this Clause 3.5.2 may be reasonably extended by the mutual written
agreement of the Parties.3.5.3
    
    Use of Documents. All documents exchanged by the Parties shall be
maintained in confidence and shall not be used for any other purpose than the
resolution of the scope of a Third Partys intellectual property rights as it pertains
to the sale of a Product as set forth in this Agreement.3.5.4
    
    Resolution. If EPIL disagrees with EntreMeds position pursuant to
the terms as set forth in Clause 3.5.2 herein and if EntreMed maintains its original
position after such review period, then the matter shall be referred first to the
officers of EPIL and EntreMed having responsibility for the subject matter of the
dispute, or their designees. Such officers, or their designees, as the case may be,
shall negotiate in good faith to resolve such dispute in a mutually satisfactory
manner. If such efforts do not result in a mutually satisfactory resolution of the
dispute within thirty (30) days of such referral, the matter shall be referred to the
chief executive officer of each Party, or their respective designees.3.5.5
    
    Final Resolution. If the Parties chief executive officers or their
designees do not resolve the dispute within thirty (30) days of the matter being
referred to them (or such longer time periods as may be mutually agreed in writing by
the Parties), an independent mutually acceptable Third Party law firm with suitable
expertise in the
 
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field of intellectual property in pharmaceuticals (the Firm) shall
be appointed to determine whether, in its opinion, the sale of the Products would infringe such Third
Party intellectual property. Once appointed, the Firm shall not be used by either
Party for matters pertaining to the EPIL Intellectual Property or the EntreMed
Intellectual Property, other than subsequent disputes under this Clause 3.5. The
costs of the Firm shall be borne by the Party with whom the Firm disagrees.3.5.6
    
    Disputes Not To Be Reopened. The procedure in Clauses 3.5.1 to 3.5.5
shall not be used more than once in relation to any particular Third Party intellectual
property allegedly infringed, absent new and relevant facts.3.5.7
    
    Negotiation. If the Parties or the Firm determine that a license
should be obtained, EPIL shall have the initial right to negotiate such license. In
the event that EPIL is unsuccessful in obtaining such a license within one hundred and
twenty (120 days) of its first meeting with such Third Party, then EntreMed shall have
the right to negotiate such license.3.5.8
    
    Terms. The Party attempting to negotiate the license shall:
 3.5.8.1
    
    use all Commercially Reasonable Efforts to achieve commercially reasonable
terms;3.5.8.2
    
    keep the other Party reasonably informed of such negotiations;3.5.8.3
    
    submit to the other Party any draft terms before approval (insofar as they
affect that other Party);3.5.8.4
    
    reasonably take into account any comments the other Party may have; and3.5.8.5
    
    without prejudice to the generality of the foregoing, use all Commercially
Reasonable Efforts to ensure that the license is sub-licensable to EntreMed
(in the case of EPIL) or freely transferable to EPIL (in the case of
EntreMed).
 3.5.9
    
    Unrelated Licenses. Nothing in this Clause 3.5 shall be construed as
affecting EntreMeds rights to obtain licenses wholly unrelated to the incorporation of
the EPIL Technology in the Product, at its own expense.
 3.6.
    
    Trademarks.
 3.6.1
    
    EntreMed Trademark.
 3.6.1.1
    
    EntreMed shall market the Product in the Territory under the EntreMed
Trademark.3.6.1.2
    
    EntreMed grants to EPIL and its Affiliates for the Term a royalty free,
worldwide, non-exclusive license to the EntreMed Trademark and, if different,
trademarks showing EntreMeds corporate logo (the EntreMed Logo), for the
purpose of EPILs promotion of its activities and of the EPIL Technology.
 
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3.6.1.3
    
    EPIL shall ensure that each reference to and use of the EntreMed Trademark
and EntreMed Logo by EPIL is in a manner approved by EntreMed and accompanied
by an acknowledgement, in a form approved by EntreMed, that the same is a
trademark (or registered trademark) of EntreMed.3.6.1.4
    
    EPIL shall not use the EntreMed Trademark or EntreMed Logo in any way
which might materially prejudice its distinctiveness or validity or the
goodwill of EntreMed therein.3.6.1.5
    
    EPIL shall not use any trademarks or trade names so resembling the
EntreMed Trademark or EntreMed Logo as to be likely to cause confusion or
deception.3.6.1.6
    
    EntreMed will be entitled to conduct all enforcement proceedings relating
to the EntreMed Trademark or EntreMed Logo and shall at its sole discretion
decide what action, if any, to take in respect of any infringement or alleged
infringement of the EntreMed Trademark or EntreMed Logo or passing-off or any
other claim or counter-claim brought or threatened in respect of the use or
registration of the EntreMed Trademark or EntreMed Logo. Any such
proceedings shall be conducted at EntreMeds expense and for its own benefit.
 3.6.2
    
    EPIL Trademark.
 3.6.2.1
    
    EntreMed shall prominently display the appropriate EPIL Trademark on the
packaging of the Product and on all promotional materials in relation to the
Product to acknowledge that EPIL Intellectual Property has been applied in
developing and manufacturing the Product.3.6.2.2
    
    EPIL grants to EntreMed for the Term a paid-up, worldwide, non-exclusive
license to the EPIL Trademark, solely for the purpose of fulfilling
EntreMeds obligations under this Clause 3.6.2.2 and exercising its rights
under this Agreement.3.6.2.3
    
    EntreMed shall ensure that each reference to and use of the EPIL Trademark
by EntreMed is in a manner approved by EPIL and accompanied by an
acknowledgement, in a form approved by EPIL, that the same is a trademark (or
registered trademark) of EPIL.3.6.2.4
    
    EntreMed shall not use the EPIL Trademark in any way which might
materially prejudice its distinctiveness or validity or the goodwill of EPIL
therein.3.6.2.5
    
    EntreMed shall not use any trademarks or trade names so resembling the
EPIL Trademark as to be likely to cause confusion or deception.3.6.2.6
    
    EPIL will be entitled to conduct all enforcement proceedings relating to
the EPIL Trademark and shall at its sole discretion decide what action, if
any, to take in respect of any infringement or alleged infringement of the
EPIL Trademark or passing-off or any other claim or counter-claim brought or
 
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4.
    
    NON-COMPETITION
 * * *
 5.
    
    REGISTRATION, MARKETING AND THE PROMOTION OF THE PRODUCT5.1.
    
    Regulatory Matters. Except as specified otherwise in this Agreement or in the
Related Agreements, EntreMed shall own and shall be responsible for filing for and maintaining
all necessary Regulatory Approvals, including for the manufacture of the Compound and any
necessary export or import licenses in relation to the Compound and/or the Product.5.2.
    
    Diligent Efforts. EntreMed shall use Commercially Reasonable Efforts:
 5.2.1
    
    to obtain Regulatory Approvals for the Product; and5.2.2
    
    to market and promote the Product with a view to achieving the commercial
potential of the Product throughout the Territory.
 5.3.
    
    Required Markings. All trade packaging and marketing materials shall:
 5.3.1
    
    to the extent permitted by law, include due acknowledgement that the Product
is developed and manufactured by EPIL or its Affiliate; and5.3.2
    
    have marked representative patent number(s) including that of the formulation
patent in respect of the EPIL Patents on the Product, or otherwise reasonably
communicate to the trade the existence of any EPIL Patents for the countries within the
Territory in such a manner as to ensure compliance with, and enforceability under,
applicable laws.
 5.4.
    
    Launch. EntreMed shall use Commercially Reasonable Efforts to effect the *
commercial launch of the Product:
 5.4.1
    
    in the USA * days of the Regulatory Approval in the USA, subject to
the timely receipt of launch stocks under the Manufacturing and Supply Agreement and
there not being any Infringement Claim pending; and5.4.2
    
    in the United Kingdom, Germany, France, Italy and Japan * days after
the relevant Regulatory Approval, subject to the timely receipt of launch stocks under
the Manufacturing and Supply Agreement and there not being any pending Infringement
Claim.
 5.5.
    
    Reporting. EntreMed shall promptly notify EPIL in writing of the date that the
Product is administered in the first patient in a Post-Phase 1b Clinical Study and in the
first patient in the
 
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*
 6.
    
    FINANCIAL PROVISIONS6.1.
    
    License Milestone Payments. In consideration of the grant of the EPIL License,
EntreMed shall pay to EPIL the following non-refundable amounts:
 6.1.1
    
    US$ * upon the earlier of (i) EntreMeds announcement of a
Post-Phase1b Clinical Study or (ii) the administration of Product to the first patient
in a Post-Phase1b Clinical Study;6.1.2
    
    Notwithstanding the milestone payment made under Clause 6.1.1(i) or 6.1.1(ii),
US$ * upon the administration of Product to the first patient in a post-Phase1b
clinical study;6.1.3
    
    US$ * upon the earlier of (i) EntreMeds announcement of the first
Pivotal Study or (ii) the administration of Product to the first patient in the first
Pivotal Study in support of a Regulatory Application;6.1.4
    
    US$ * upon the administration of Product to the first patient in the
first Pivotal Study in support of a Regulatory Application;6.1.5
    
    US$ * upon completion of production and packaging of the first ICH
Qualifying Batch of Product;6.1.6
    
    US$ * upon the execution of all validation protocols and the
completion of a validation report for the commercial manufacturing process;6.1.7
    
    US$ * upon the acceptance for filing of the first Regulatory
Application in the US;6.1.8
    
    US$ * upon the acceptance for filing of the first Regulatory Application in
the EEA * ;6.1.9
    
    US$ * upon the  * acceptance for filing of the first
Regulatory Application in Japan * ;6.1.10
    
    US$ * upon the (i) successful FDA pre-approval inspection (PAI) of a
commercial manufacturing facility, as indicated by FDA *
 
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* *
 6.1.11
    
    US$ * upon the first In Market Sale in the US;6.1.12
    
    US$ * the first In Market sale in the EEA * ; and6.1.13
    
    US$ upon * the first In Market sale in Japan or * .the payments described in this Clause 6.1 being License Milestone Payments.
 6.2.
    
    Compensation Fee. In the event that EntreMed executes a Third Party agreement for the supply of Compound for
* , EntreMed will pay to EPIL a compensation fee of * the Compensation
Fee). For clarification purposes, the Compensation Fee will not be required to be paid in the event that
EntreMed discontinues the development of the Product for any reason and *.6.3.
    
    Not Subject to Future Performance Obligations. The License Milestone Payments shall
not be subject to future performance obligations of EPIL to EntreMed and shall not be
applicable against future services provided by EPIL to EntreMed.The terms of Clause 6.1 relating to the License Milestone Payments are independent and
distinct from the other terms of this Agreement.6.4
    
    Royalty on Sales for the Initial Term. In further consideration of the grant of the EPIL License, EntreMed shall pay to EPIL a
non-refundable stepped royalty of
*
of aggregate Net Sales for the
first
* of annual
aggregate Net Sales in the Territory increasing to * of aggregate Net Sales for all amounts of annual aggregate Net
Sales greater than *in the Territory, for the Initial Term.6.5
    
    Royalty on Sales for the Extended Term and any additional Extended Term. In further consideration of the continuing grant by
EPIL to EntreMed of a license to use the EPIL Know-How during the Extended Term, EntreMed shall pay to EPIL a non-refundable
royalty of * of aggregate Net Sales in the Territory provided this Agreement has not been terminated
* pursuant to Clause 9.6.6
    
    Generic Competition. If during any calendar quarter of the Extended Term, one or more Generics is marketed and all such
Generics achieve in any country of the Territory an aggregate market share of not less than * percent (* %)
(calculated by reference to the total sales of the Product and all Generics, as demonstrated to the reasonable satisfaction of
EPIL), the royalty payable to EPIL shall be reduced to * percent (* %) in respect of that country in that calendar
quarter. For the avoidance of doubt, no such reduction shall apply after such circumstances are eliminated, nor in any country
where such circumstances do not apply.6.7.
    
    Bundling. During the Term, in the event that EntreMed, its Affiliates or a permitted
Third Party sub-licensee shall sell to Third Party purchasers the Product together with other
products, with pricing of the Product tied to pricing or volume of purchase of other products
(by the method
 
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*
 *
 6.8.
    
    Method of calculation of fees. The Parties acknowledge and agree that the methods
for calculating the milestones, royalties and fees under this Agreement are for the purposes
of the convenience of the Parties, are freely chosen and not coerced.7.
    
    MANUFACTURE AND SUPPLY7.1.
    
    Manufacturing and Supply Agreement. The Parties agree that they, or their respective
Affiliates, will negotiate in good faith a Manufacturing and Supply Agreement for the
commercial supply of Product which they shall aim to execute on or before the first
anniversary of entering into this Agreement. The Parties agree that the Manufacturing and
Supply Agreement shall incorporate Clauses 7.2 and 7.3 and the key terms set out in Schedule
5.7.2.
    
    Supply. The Parties agree that EPIL or an Affiliate shall have the exclusive right to
manufacture and supply to EntreMed, its Affiliates and permitted sub-licensees their entire
requirement of the Product in the Territory for commercial purposes in accordance with the
Manufacturing and Supply Agreement that will be negotiated in good faith between the Parties
or between EntreMed and an Affiliate of EPIL. The cost of goods for Product supplied pursuant
to the Manufacturing and Supply Agreement containing
a* percent
(*%) API
concentration shall be as set out in Schedule 4. The cost of goods for Product supplied under
the Manufacturing and Supply Agreement * . The Parties further agree that the
Manufacturing and Supply Agreement shall contain provisions
relating to
*.7.3.
    
    Right to Manufacturing License. Subject to the terms of this Agreement and the
Manufacturing and Supply Agreement, the Parties further agree that in the event EPIL or any
EPIL Affiliate is unable to manufacture the Product for commercial purposes for reasons of
failure to supply (as such will be set out in more detail in the Manufacturing and Supply
Agreement), EPIL shall grant to EntreMed a non-exclusive license under the EPIL Intellectual
Property to make or have made the Product in the Field in the Territory (the Manufacturing
License). Subject to the prior
 
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* Designated
Manufacturer * * *
 8.
    
    PAYMENTS, REPORTS AND AUDITS8.1.
    
    Records. Commencing with the first In Market sale in the Territory, EntreMed shall
keep true and accurate records of gross sales of the Product, the items deducted from the
gross amount in calculating the Net Sales, the Net Sales and the royalties payable to EPIL
under Clauses 6.4. and 6.5, as applicable EntreMed shall deliver to EPIL a written statement
(the Statement) thereof within forty-five (45) days following the end of each calendar
quarter, (or any part thereof in the first or last calendar quarter of this Agreement) for
such calendar quarter. The Statement shall outline on a country-by-country basis, the
calculation of the Net Sales from gross revenues during that calendar quarter, the applicable
percentage rate, and a computation of the sums due to EPIL. The Parties financial officers
shall agree upon the precise format of the Statement.8.2.
    
    Foreign Currency. Payments due on Net Sales of the Product based on sales amounts in
a currency other than US$ shall first be calculated in the foreign currency and then converted
to US$ on the basis of the exchange rate in effect for the purchase of US$ with such foreign
currency quoted in the Wall Street Journal (or comparable publication if not quoted in the
Wall Street Journal) over the five (5) business days prior to the end of the relevant calendar
quarter in which such payment is due.8.3.
    
    VAT. All payments to EPIL are exclusive of any applicable value added or any other
sales tax, for which EntreMed will be additionally liable if applicable.8.4.
    
    Taxes. If EntreMed is required by law to pay or withhold any income or other taxes
on behalf of EPIL with respect to any monies payable to EPIL under this Agreement:
 8.4.1
    
    EntreMed shall deduct them from the amount of such monies due;8.4.2
    
    any such tax required to be paid or withheld shall be an expense of and borne
solely by EPIL;8.4.3
    
    EntreMed shall promptly provide EPIL with a certificate or other documentary
evidence to enable EPIL to support a claim for a refund or a foreign tax credit.
 8.5.
    
    Double Tax Co-operation. EPIL and EntreMed agree to co-operate reasonably as may be
necessary to take advantage of any double taxation agreements or similar agreements as may,
from time to time, be available in order to enable EntreMed to make such payments to EPIL
without any deduction or withholding.
 
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8.6.
    
    Timing. Payments to EPIL shall be made as follows:
 8.6.1
    
    each of the License Milestone Payments shall be paid within fifteen (15)
calendar days of the achievement of the relevant event to which they relate; and8.6.2
    
    payment of royalties shall be made upon provision of the Statement (45 days
following the end of the calendar quarter).
 8.7.
    
    Manner of Payment. All payments due hereunder shall be made in US$ to the designated
bank account of EPIL in accordance with such timely written instructions as EPIL shall from
time to time provide.8.8.
    
    Interest. Without prejudice to EPILs other remedies hereunder, EntreMed shall pay
interest to EPIL on sums not paid to EPIL on the date on which payment should have been made
pursuant to the applicable provisions of this Agreement (Due Date) over the period from the
Due Date until the date of actual payment (both before and after judgement) at the Prime Rate
publicly announced by Morgan Guaranty Trust Company of New York at its principal office on the
Due Date (or next to occur Business Day, if such date is not a Business Day) plus *%,
such interest to payable on demand from time to time and compounded monthly. Interest shall
be payable both before and after judgment.8.9.
    
    Audit. For the one hundred and eighty (180) day period following the close of each
calendar year of the Agreement, EntreMed will, in the event that EPIL reasonably requests such
access, provide EPILs independent certified accountants (reasonably acceptable to EntreMed)
with access, during regular business hours, no more than once per calendar year unless a
discrepancy is discovered, and subject to the confidentiality provisions as contained in this
Agreement, to EntreMeds books and records relating to the Product, solely for the purpose of
verifying the accuracy and reasonable composition of the calculations under this Agreement for
the calendar year then ended.8.10.
    
    Correction of Discrepancies. In the event of a discovery of a discrepancy, a
correcting payment shall be made by EntreMed to EPIL together with interest at the rate
specified in Clause 8.8. If the discrepancy exceeds * percent *%) of
the amount due then additionally the cost of such accountants shall be borne by EntreMed.9.
    
    DURATION AND TERMINATION9.1.
    
    Initial Term. This Agreement shall be deemed to have come into force on the
Effective Date and, subject to the rights of termination outlined in this Clause 9 and the
provisions of applicable laws, will expire on a country-by-country basis:
 9.1.1
    
    on the* anniversary of the date of the first In Market sale of the
Product in the country concerned; or9.1.2
    
    in any country upon the expiration of the life of the last to expire patent
having a Valid Claim where such patent is included in the EPIL Intellectual Property in
that country;whichever date is* to occur (the Initial Term).
 9.2.
    
    Continuation. At the end of the Initial Term in such country, this Agreement shall continue automatically for * year periods
thereafter (collectively known as the Extended Term),
 
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* *
 9.3.
    
    Term. The Initial Term and the Extended Term shall collectively be referred to as
the Term in this Agreement.9.4.
    
    Breach / Insolvency. In addition to the rights of termination provided for elsewhere
in this Agreement, either Party will be entitled forthwith to terminate this Agreement by
written notice to the other Party if:
 9.4.1
    
    that other Party commits a material breach of any of the provisions of this
Agreement, and fails to cure the same within sixty (60) days after receipt of a written
notice from another Party hereto giving full particulars of the breach and requiring it
to be remedied; provided, that if the breaching Party has proposed a course of action
to cure the breach and is acting in good faith to cure same but has not cured the
breach by the sixtieth (60th) day after receipt of a written notice, such
period shall be extended by such period as is reasonably necessary to permit the breach
to be cured, provided that such period shall not be extended by more than thirty (30)
additional days, unless otherwise agreed in writing by the Parties;9.4.2
    
    that other Party goes into liquidation under the laws of any applicable
jurisdiction (except for the purposes of amalgamation or reconstruction and in such
manner that the company resulting therefrom effectively agrees to be bound by or assume
the obligations imposed on that other Party under this Agreement);9.4.3
    
    a receiver, administrator, examiner, trustee or similar officer is appointed
over all or substantially all of assets of that other Party under the laws of any
applicable jurisdiction; or9.4.4
    
    any proceedings are filed or commenced by that other Party under bankruptcy,
insolvency or debtor relief laws, or anything analogous to any of the foregoing under
the laws of any applicable jurisdiction occurs in relation to that other Party.
 9.5.
    
    Additional EntreMed Termination Rights. EntreMed shall be entitled to terminate this
Agreement for any country or countries of the Territory by written notice to EPIL where:
 9.5.1
    
    the sale of the Product is prohibited by the RHA in such country or countries;9.5.2
    
    despite having used Commercially Reasonable Efforts, EntreMed is unable to
obtain Regulatory Approval for the Product in such country or countries so as to permit
a reasonable commercial return for EntreMed.
 9.6.
    
    Additional EPIL Termination Rights. In further addition to the rights and
termination provided for elsewhere in this Agreement, EPIL shall be entitled to terminate this
Agreement for any country or countries of the Territory in the event that EntreMed fails to
file a Regulatory Application in the United States within * of the date that Pivotal
Studies are completed in relation to the first Product indication. However:
 9.6.1
    
    If, *, EntreMed has and is continuing to use Commercially
Reasonable Efforts to complete the supporting clinical studies and file such US
 
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9.6.2
    
    In the event that the EntreMed failure to file such US Regulatory
Application is due to EPILs or its Affiliates decision not to manufacture the
Product,
* ;9.6.3
    
    In the event that, during the Term, EntreMed, its sublicensee or their
respective Affiliates
*, EPIL, *, shall be entitled to terminate this
Agreement and the Related Agreements in their entirety.
 9.7.
    
    Cross-Termination. In the event this Agreement is terminated *, pursuant to
the terms as set forth in this Clause 9, other than the surviving provisions as set forth in
the Related Agreements, the MEEA and the CSA, as these agreements pertain to the Compound
and/or the Product, if applicable, the Related Agreements, the MEEA and the CSA shall
automatically terminate and be of no further legal force and effect as related to Compound
and/or the Product.10.
    
    CONSEQUENCES OF TERMINATION10.1.
    
    General Consequence. Upon exercise of those rights of termination specified in
Clause 9 herein or elsewhere in this Agreement, this Agreement shall, subject to Clauses 10.2,
automatically terminate forthwith and be of no further legal force or effect.10.2.
    
    Specific Consequences. Upon termination of the Agreement by either Party, or upon
termination by EPIL of the EPIL License for a particular country under Clauses 9.6 herein, the
following shall be the consequences relating to the Territory or the particular country, as
applicable:
 10.2.1
    
    any sums that were due from EntreMed to EPIL under the provisions of this Agreement
prior to its termination or expiry, or become due by virtue of such termination or
expiry, shall be paid in full within thirty (30) calendar days of termination of this
Agreement or termination of the EPIL Licence in a particular country, as applicable,
and EPIL shall not be liable to repay to EntreMed any amount of money paid or payable
by EntreMed to EPIL up to the date of the termination of this Agreement;10.2.2
    
    where a License Milestone Payment is due by reference to some period after an event,
and termination occurs after such event but before the due date for such License
Milestone Payment, such License Milestone Payment shall become immediately due and
payable and shall be paid in accordance with the provisions of Clause 10.2.1; and for
the avoidance of doubt, EntreMed liability for any then accrued License Milestone
Payments shall not otherwise be affected by virtue of termination of this Agreement;10.2.3
    
    all representations and warranties shall insofar are appropriate remain in full force
and effect;10.2.4
    
    the provisions of this Agreement regarding with respect to confidentiality and
non-use of materials or confidential information shall remain in effect for a further
period of 10 (ten) years from such date of termination.
 
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10.2.5
    
    the rights of inspection and audit shall continue in force for the period referred to
in the relevant provisions of this Agreement;10.2.6
    
    the license granted by EPIL to EntreMed of the EPIL Trademark under Clause 3.6.2.2
shall automatically terminate;10.2.7
    
    any other provision of this Agreement which, by its nature, is intended to continue
after termination, shall survive termination;10.2.8
    
    any sub-license granted under Clause 2.2 shall automatically terminate;.
 11.
    
    WARRANTIES, INDEMNIFICATION AND LIABILITY11.1.
    
    EPIL Warranties. EPIL represents and warrants to EntreMed as of the Effective Date,
as follows:
 11.1.1
    
    EPIL has the right to enter into this Agreement and grant the EPIL License.11.1.2
    
    Other than the Merck Agreement, there are no agreements between EPIL and any Third
Party that conflict with the EPIL License.11.1.3
    
    EPIL is the owner of the EPIL Patents.11.1.4
    
    EPIL or its Affiliates are not obligated to assign to any sublicensee or any Third
Party any EntreMed Improvements made by EPIL or its Affiliates or made on EPILs behalf
by its sublicensees or Third Party contract manufacturers.11.1.5
    
    Except for the oppositions in the European Patent Office of EP-B-499299 and
EP-1185371 EPIL has not been notified or does not otherwise have knowledge of any
infringement proceedings, actions, suits or complaints pending against nor any
outstanding injunctions, judgments, orders, decrees, rulings or other charges against
EPIL or any Affiliate of EPIL in connection with the EPIL Patents or the EPIL Know How
in the Territory that may affect the making, using, or selling of the Product.11.1.6
    
    To the best knowledge of EPIL, with no special search, the use of the EPIL
Technology in the making, using, selling or importation of the Product does not
infringe any intellectual property rights of a Third Party patents in the Territory.
 11.2.
    
    EntreMed Warranties. EntreMed represents and warrants to EPIL as of the Effective
Date, as follows:
 11.2.1
    
    EntreMed has the right to enter into this Agreement and the Related Agreements.11.2.2
    
    There are no agreements between EntreMed and any Third Party that conflict with this
Agreement.11.2.3
    
    EntreMed is the owner or exclusive licensee of the EntreMed Patents.11.2.4
    
    EntreMed or its Affiliates are not obligated to assign to any sublicensee or any
Third Party any EPIL Improvements made by EntreMed or its Affiliates or made on
EntreMeds behalf by its sublicensees or Third Party contract manufacturers.
 
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11.2.5
    
    EntreMed has not been notified of any infringement proceedings, actions, suits or
complaints pending against nor any outstanding injunctions, judgments, orders, decrees,
rulings or other charges against EntreMed or any Affiliate of EntreMed in connection
with the EntreMed Patents or the EntreMed Know-How in the Territory that may affect the
making, using, or selling of the Product.11.2.6
    
    To the best knowledge of EntreMed, with no special search, the use of the EntreMed
Intellectual Property in the making, using, selling or importation of the Product does
not infringe any intellectual property rights of a Third Party in the Territory.
 11.3.
    
    Mutual Indemnification. Each of the Parties shall indemnify and hold harmless the
other Party against all Claims insofar as they arise out of or in connection with any breach
by the first Party of any of its representations, obligations or warranties under this
Agreement or from the first Partys fraud or wilful misconduct.11.4.
    
    Infringement Claims. The Parties acknowledge that Clause 3.4 herein contains the
Parties full agreement as regards liability for Infringement Claims, save to the extent that
Clause 3.4 incorporates other provisions of this Agreement by specific cross-reference.11.5.
    
    Indemnification (Medical Claims). EntreMed shall indemnify EPIL against all Claims
made or brought against EPIL or its Affiliates seeking damages for personal injury (including
death) and/or for the cost of medical treatment, caused by or attributed to the Product.11.6.
    
    Sub-licensees. With reference to Clause 2.2.3 herein, EntreMed shall indemnify and
hold harmless EPIL or its Affiliates to the extent that any Claims arise out of any such acts
or omissions of any sub-licensee.11.7.
    
    Conduct of Claims. The Party seeking an indemnity shall:
 11.7.1
    
    fully and promptly notify the other Party of any Claim or proceedings, or threatened
Claim or proceedings;11.7.2
    
    permit the indemnifying Party to take full control of such Claim or proceedings at
its sole cost and expense, with counsel of the indemnifying Partys choice, provided
that the indemnifying Party shall reasonably and regularly consult with the indemnified
Party in relation to the progress and status of such Claim or proceedings;11.7.3
    
    co-operate in the investigation and defence of such Claim or proceedings; and11.7.4
    
    take all reasonable steps to mitigate any loss or liability in respect of any such
Claim or proceedings.
  11.8.
    
    Exclusion of Implied Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
ENTREMED ACKNOWLEDGES THAT THE EPIL LICENSE IS GRANTED ON AN AS IS BASIS, WITHOUT
REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY,
FITNESS
 
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11.9.
    
    Exclusion of Consequential Loss. WITHOUT PREJUDICE TO THE OBLIGATION OF EITHER
PARTY TO INDEMNIFY THE OTHER IN RESPECT OF CLAIMS BY A THIRD PARTY, NOTWITHSTANDING ANYTHING
TO THE CONTRARY IN THIS AGREEMENT, EPIL AND ENTREMED SHALL NOT BE LIABLE TO THE OTHER BY
REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW,
OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL,
INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF
ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE
PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.11.10.
    
    Extension of Indemnification. Where this Agreement provides for the indemnification
of a Party to this Agreement or for the limitation of a Partys liability, such
indemnification and/or limitation (as the case may be) shall also apply for the benefit of
such Partys Affiliates and the employees, officers, directors and agents of any of them,
acting in such capacity.11.11.
    
    Indemnification of Affiliates. Where this Agreement provides for the
indemnification of a Party, such indemnification shall also apply for the benefit of such
Partys Affiliates and the employees, officers, directors and agents of any of them, acting in
such capacity.12.
    
    CONFIDENTIALITY12.1.
    
    Confidential Information: The Parties agree that it will be necessary, from time to
time, to disclose to each other confidential and proprietary information, including without
limitation, inventions, trade secrets, specifications, designs, data, know-how and other
proprietary information relating to EPIL Intellectual Property, EntreMed Intellectual
Property, the Product, processes, services and business of the disclosing Party.The foregoing shall be referred to collectively as Confidential Information.12.2.
    
    Exclusion. Confidential Information shall be deemed not to include:
 12.2.1
    
    information which is in the public domain;12.2.2
    
    information which is made public through no breach of this Agreement;12.2.3
    
    information which is independently developed by a Party, as evidenced by such Partys
records; or12.2.4
    
    information that becomes available to a receiving Party on a non-confidential basis,
whether directly or indirectly, from a source other than the other Party hereto, which
source did not acquire this information on a confidential basis.
 12.3.
    
    Use of Confidential Information. Any Confidential Information disclosed by the
disclosing Party shall be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Partys
 
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12.4.
    
    Non-Disclosure. Except as otherwise specifically provided in this Agreement, each
Party shall disclose Confidential Information of the other Party only to those employees,
representatives and agents requiring knowledge thereof in connection with fulfilling the
Partys obligations under this Agreement, and not to any other Third Party.12.5.
    
    Obligation to Inform. Each Party further agrees to inform all such employees,
representatives and agents of the terms and provisions of this Agreement relating to
Confidential Information and to obtain their agreement hereto as a condition of receiving
Confidential Information.12.6.
    
    Care. Each Party shall exercise the same standard of care as it would itself
exercise in relation to its own confidential information (but in no event less than a
reasonable standard of care) to protect and preserve the proprietary and confidential nature
of the Confidential Information disclosed to it by the other Party.12.7.
    
    Return of Information. Upon termination or expiration of this Agreement, each Party
shall promptly, upon the written request of the other Party, return all documents and any
copies thereof containing Confidential Information belonging to, or disclosed by, such other
Party, save that it may retain one copy of the same solely for the purposes of ensuring
compliance with this Clause 12.12.8.
    
    Attribution. Any breach of this Clause 12 by any person informed by one of the
Parties is considered a breach by the Party itself.12.9.
    
    Acknowledgment. The Parties agree that the obligations of this Clause 12 are
necessary and reasonable in order to protect the Parties respective businesses. The Parties
further agree that monetary damages may be inadequate to compensate a Party for any breach by
the other Party of its covenants and agreements with respect to confidentiality, and that each
Party shall be entitled to seek injunctive or other equitable relief against the threatened or
continued breach of those provisions, in addition to with any other remedy which may be
available.12.10.
    
    Compound Data. For the purpose of demonstrating to Third Parties the benefits of
the EPIL Technology, EPIL shall be entitled, subject to the prior written consent of EntreMed
which shall not be unreasonably withheld, conditioned or delayed, to disclose to Third Parties
the numerical values underlying the Compound data provided that EPIL does not disclose
EntreMeds name or the name of the Compound and that the above consent requirement shall not
be deemed to apply to any numerical values that have already been publicly disclosed by
EntreMed.12.11.
    
    Announcements. No announcement or public statement concerning the existence,
subject matter or any term of this Agreement, or its performance, shall be made by or on
behalf of any Party without the prior written approval of the other, such approval not to be
unreasonably withheld, conditioned or delayed.12.12.
    
    Joint Press Release. The Parties agree to discuss the issue of a joint press
release announcing the execution of this Agreement. If the Parties decide not to issue a
joint press release regarding this event, then each Party shall be entitled to issue its own
press release, but the wording of each such release shall be agreed to by the other Party in
writing before publication. Following the publication of said initial press release(s), each
Party shall be free to disclose, without the other Parties prior written consent, the
existence of this Agreement, the identity of the other Party and
 
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12.13
    
    Other Disclosures. EntreMed shall be entitled to provide (i) a copy of this Agreement and Related Agreements in which all
financial terms have been redacted to Third Parties that have expressed a genuine and legitimate interest in partnering or
collaborating with EntreMed to commercialize the Product in the Territory or (ii) a full copy of this Agreement or Related
Agreements to Third Parties that have expressed a genuine and legitimate interest in acquiring EntreMed or substantially all of
EntreMeds business assets. EPIL shall be entitled to provide a full copy of this Agreement and Related Agreements to Third
Parties that have expressed an interest in acquiring EPIL Technology from EPIL as it relates to the manufacture or
commercialization of Product. In each case, each such Third Party shall be bound by a confidentiality agreement with terms and
conditions that are at least as restrictive as that set forth in this Article 12. The Parties further agree that EntreMeds
right to supply any such information to a Third Party that is a Technological Competitor shall require EPILs prior written
consent, * .12.14.
    
    Required Disclosures. A Party (the Disclosing Party) will be entitled to make an
announcement or public statement concerning the existence, subject matter or any term of this
Agreement, or to disclose Confidential Information that the Disclosing Party is required to
make or disclose pursuant to:12.14.1     a valid order of a court or Governmental Authority; or12.14.2     any other requirement of law or any securities or stock exchange;provided that if the Disclosing Party becomes legally required to make such announcement,
public statement or disclosure hereunder, the Disclosing Party shall give the other Party
prompt notice of such fact to enable the other Party to seek a protective order or other
appropriate remedy concerning any such announcement, public statement or disclosure,
including confidential treatment and/or appropriate redactions.The Disclosing Party shall fully co-operate with the other Party in connection with that
other Partys efforts to obtain any such order or other remedy. If any such order or other
remedy does not fully preclude announcement, public statement or disclosure, the Disclosing
Party shall make such announcement, public statement or disclosure only to the extent that
the same is legally required.13.
    
    MISCELLANEOUS PROVISIONS13.1.
    
    Force Majeure. Neither Party shall be liable for failure or delay in the
performance of any of its obligations under this Agreement if such failure or delay results
from Force Majeure, but any such failure or delay shall be remedied by such Party as soon as
practicable.13.2.
    
    Assignment.
 
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13.2.1
    
    EntreMed shall not be entitled to subcontract or delegate the whole or any part
of its duties hereunder or to assign this Agreement to its Affiliate(s) where EntreMed
becomes an Affiliate of a Technological Competitor unless the provisions of Clause 2.2
have been fully complied with. Subject to the foregoing, each Party be entitled without
the consent of the other:
 13.2.1.1
    
    to subcontract or delegate the whole or any part of its duties hereunder
to its Affiliate(s); and/or13.2.1.2
    
    to assign this Agreement to its Affiliate, provided that such assignment
has no material adverse tax implications for the other Party.
 13.2.2
    
    Except as provided for in Clause 13.2.1, this Agreement may not be assigned by a
Party without the prior written consent of the other, which shall not be unreasonably
withheld or delayed.
 13.3.
    
    Parties Bound. This Agreement shall be binding upon and run for the benefit of the
Parties, their successors and permitted assigns.13.4.
    
    Relationship of the Parties. In this Agreement, nothing shall be deemed to
constitute a partnership between the Parties or make either Party an agent for the other, for
any purpose whatsoever.13.5.
    
    Entire Agreement. Without prejudice to Clause 13.13, this Agreement, together with
the Related Agreements, constitutes the entire agreement and understanding between the Parties
with respect to its subject matter, and except as expressly provided, supersedes all prior
representations, writings, negotiations or understandings with respect to that subject matter.Nothing in this Clause 13.5 shall exclude any liability which any Party would otherwise have
to the other Party or any right which either of them may have to rescind this Agreement in
respect of any statements made fraudulently by the other prior to the execution of this
Agreement or any rights which either of them may have in respect of fraudulent concealment
by the other.13.6.
    
    Severability. If any provision in this Agreement is deemed to be, or becomes
invalid, illegal, void or unenforceable under applicable laws, such provision will be deemed
amended to conform to applicable laws so as to be valid and enforceable, or if it cannot be so
amended without materially altering the intention of the parties, it will be deleted, but the
validity, legality and enforceability of the remaining provisions of this Agreement shall not
be impaired or affected in any way.13.7.
    
    Further Assurance. Each Party shall do and execute, or arrange for the doing and
executing of, each necessary act, document and thing reasonably within its power to implement
this Agreement.13.8.
    
    Counterparts. This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of which when taken together
shall constitute this Agreement.13.9.
    
    Waivers. A failure to exercise or delay in exercising a right or remedy provided by
this Agreement or by law does not constitute a waiver of the right or remedy or a waiver of
other rights or remedies. No single or partial exercise of a right or remedy provided by this
Agreement
 
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13.10.
    
    Variations. No variation of this Agreement shall be effective unless it is made in
writing and signed by each of the Parties.13.11.
    
    Notices.
 13.11.1
    
    A notice under or in connection with this Agreement (a Notice):
 13.11.1.1
    
    shall be in writing; and13.11.1.2
    
    may be delivered personally or sent by first class post (and air mail if
overseas) or by fax to the Party due to receive the Notice at its address set
out below:
 13.11.2
    
    The address referred to in Clause 13.11.1.2 is:
 (a)
    
    in the case of EPIL:
 Address:
    
    Elan Pharma International LimitedMonkslandAthloneCo. WestmeathIrelandFax:
    
    +353 90 649 2427Marked for the attention of :
    
    Vice President and General CounselElan Drug Technologies
 
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(b)
    
    in the case of EntreMed:
 Address:
    
    EntreMed, Inc.9640 Medical Center DriveRockville, MD 20850Fax:
    
    +1 240 864 2624Marked for the attention of :
    
    Vice President of Corporate Development
 13.11.3
    
    Notice is deemed given:
 13.11.3.1
    
    if delivered personally, when the person delivering the notice obtains
the signature of a person at the address referred to in Clause 13.11.1.2;13.11.3.2
    
    if sent by post, except air mail, two Business Days after posting it;13.11.3.3
    
    if sent by air mail, six Business Days after posting it;13.11.3.4
    
    if sent by fax, when confirmation of its transmission has been recorded
by the senders fax machine.
 13.12
    
    Set-off. Each of the Parties will be entitled but not obliged to set-off against
any amount of money payable to it by the other Party under this Agreement, any amount of money
payable by it to the other Party under this Agreement.13.13
    
    To the extent there is a conflict in the terms, conditions or procedures as set forth in
this Agreement, the Related Agreements, the MEEA, and the CSA the terms, conditions or
procedures of this Agreement shall govern. The Parties further agree that the Letter
Agreement shall terminate in its entirety upon the Effective Date.13.14
    
    Governing Law and Jurisdiction: This Agreement shall be governed by and construed
in accordance with the laws of New York, without regard to its conflict of laws rules, and
shall be subject to the exclusive jurisdiction of New York.
  
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SIGNED
 /s/ Elan Pharma International Limited   ELAN PHARMA INTERNATIONAL LIMITED
 SIGNED
 /s/ EntreMed, Inc.   ENTREMED, INC.
 
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SCHEDULE 1 EPIL PATENTS
 Title of Invention
    
    Country
    
    Patent/Appln. No.Surface Modified Drug Nanoparticles
    
    U.S.
    
    5,145,684EU
    
    EP 499299Argentina
    
    AR 255241Australia
    
    654836Canada
    
    2,059,432*
    
    *Columbia
    
    24635Finland
    
    108333Hungary
    
    221,586*
    
    *Israel
    
    100754Japan
    
    92/11226S. Korea
    
    200061Malaysia
    
    MY-108134-AMexico
    
    176345New Zealand
    
    241362Norway
    
    303668Philippines
    
    29069Russia
    
    2066553Singapore
    
    55104Taiwan
    
    NI-071312Solid Dose Nanoparticulate Compositions Comprising a
Synergistic Combination of a Polymeric Surface Stabilizer
and Dioctyl Sodium Sulfosuccinate
    
    U.S.
    
    6,375,986*
    
    *
 
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Title of Invention
    
    Country
    
    Patent/Appln. No.*
    
    **
    
    **
    
    *Nanoparticulate dispersions comprising a synergistic
combination of a polymeric surface stabilizer and dioctyl
sodium sulfosuccinate
    
    U.S.
    
    6,592,903Nanoparticulate Compositions of Angiogenesis Inhibitors
    
    U.S.
    
    10/392,403*
    
    **
    
    *Japan
    
    2003-577857*
    
    *Redispersible Nanoparticulate Film Matrices With
Protective Overcoats
    
    U.S.
    
    5,573,783Canada
    
    2,212,803Europe
    
    EP 812187*
    
    *Continuous Method of Grinding Pharmaceutical Substances
    
    U.S.
    
    5,718,388Argentina
    
    Patent No. AR 253558 V1Canada
    
    Patent. No. 2,190,134Taiwan
    
    Patent No. NI-122518Europe
    
    EP 804161Israel
    
    Patent No. 113851Japan
    
    Patent No. 3607294Malaysia
    
    Patent No. MY-113,569-APhilippines
    
    Patent No. 31497Venezuela
    
    Patent No. 0854/95Method of Grinding Pharmaceutical Substances
    
    U.S.
    
    5,862,999Argentina
    
    Patent No. AR 254497 V1*
    
    *Taiwan
    
    Patent No. NI-112433Europe
    
    EP 760653
 
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Title of Invention
    
    Country
    
    Patent/Appln. No.Israel
    
    Patent No. 113852*
    
    *Malaysia
    
    Patent No. MY-112,458-APhilippines
    
    Patent No. 1-1995-50573Venezuela
    
    Patent No. 0853-95Methods for Preventing Crystal Growth and Particle
Aggregation in Nanoparticle Compositions
    
    U.S.
    
    6,267,989*
    
    *Canada
    
    Patent No. 2,367,096Europe
    
    EP 1161229Process of Preparing Therapeutic Compositions Containing
Nanoparticles
    
    U.S.
    
    5,510,118Use of Ionic Cloud Point Modifiers to Prevent Particle
Aggregation During Sterilization
    
    U.S.
    
    5,298,262Use of Non-Ionic Cloud Point Modifiers to Minimize
Nanoparticulate Aggregation During Sterilization
    
    U.S.
    
    5,346,702Use of Purified Surface Modifiers to Prevent Particle
Aggregation During Sterilization
    
    U.S.
    
    5,352,459Argentina
    
    Patent No. AR 255267 V1Mexico
    
    Patent No. 190632Method of Preparing Stable Drug Nanoparticles
    
    U.S.
    
    5,534,270Formulations of Compounds as Nanoparticulate Dispersions
in Digestible Oils or Fatty Acids
    
    U.S.
    
    5,571,536U.S.
    
    5,560,931Europe
    
    EP 808154Microprecipitation of Nanoparticulate Pharmaceutical Agents
    
    U. S.
    
    5,560,932Pharmaceutical Compositions Containing Polyalkylene Block
Copolymers Which Gel at Physiological Temperature
    
    U.S.
    
    5,565,188U.S.
    
    5,705,194*
    
    *Europe
    
    EP 810855
 
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\

Title of Invention
    
    Country
    
    Patent/Appln. No.*
    
    *Sulfated Non-Ionic Block Copolymer Surfactant as
Stabilizer Coatings for Nanoparticle Compositions
    
    U.S.
    
    5,569,448Formulations of Oral Gastrointestinal Therapeutic Agents
in Combination with Pharmaceutically Acceptable Clays
    
    U. S.
    
    5,585,108Butylene Oxide-Ethylene Oxide Block Copolymer Surfactants
as Stabilizer Coatings for Nanoparticle Compositions
    
    U.S.
    
    5,587,143*
    
    *Europe
    
    EP 804162Israel
    
    Patent No. 114354Japan
    
    Patent No. 3710811Sugar Based Surfactant for Nanocrystals
    
    U.S.
    
    5,622,938Microprecipitation of Nanoparticulate Pharmaceutical
Agents Using Surface Active Material Derived From Similar
Pharmaceutical Agents
    
    U.S.
    
    5,716,642Use of PEG-Derivatized Lipids as Surface Stabilizers for
Nanoparticle Compositions
    
    U.S.
    
    6,270,806*
    
    *Canada
    
    Patent No. 2,362,508Europe
    
    EP 1156788Controlled Release of Nanoparticle Compositions
    
    *
    
    **
    
    **
    
    **
    
    *Bioadhesive Nanoparticle Compositions Having Cationic
Surface Stabilizers
    
    US
    
    6,428,814*
    
    **
    
    **
    
    *Europe
    
    EP 1217993Small Scale Mill and Method Thereof
    
    US
    
    6,431,478
 
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Title of Invention
    
    Country
    
    Patent/Appln. No.US
    
    6,745,962*
    
    **
    
    **
    
    *Europe
    
    EP 1185371Rapidly Disintegrating Oral Dosage Form
    
    US
    
    6,316,029*
    
    **
    
    **
    
    **
    
    *Nanoparticulate Compositions Comprising Copolymers of
Vinyl Pyrrolidone and Vinyl Acetate as Surface Stabilizers
    
    *
    
    **
    
    **
    
    **
    
    **
    
    *Stabilization of Chemical Compounds Using Nanoparticulate
Technology
    
    *
    
    **
    
    **
    
    **
    
    *Compositions Having a Combination of Controlled Release
and Immediate Release Characteristics
    
    U.S.
    
    6,908,626*
    
    **
    
    **
    
    *Apparatus for Sanitary Wet Milling
    
    U.S.
    
    6,582,285*
    
    **
    
    **
    
    *
 
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Title of Invention
    
    Country
    
    Patent/Appln. No.*
    
    *Fast Dissolving Dosage Forms Having Reduced Friability
    
    *
    
    **
    
    **
    
    **
    
    **
    
    *Method of Grinding Pharmaceutical Substances
    
    U.S.
    
    5,518,187Argentina
    
    Patent No. 251001Australia
    
    Patent No. 660852*
    
    *Taiwan
    
    Patent No. NI-69476Czech Republic
    
    Patent No. 284802Europe
    
    Patent No. EP 600528Finland
    
    Patent No. 108399Hungary
    
    Patent No. 210928*
    
    *South Korea
    
    Patent No. 312798Malaysia
    
    Patent No. MY-109,419-AMexico
    
    Patent No. 189779New Zealand
    
    Patent No. 248813*
    
    *Philippines
    
    Patent No. 31118Slovak Republic
    
    Patent No. 281078*
    
    *Venezuela
    
    Patent No. 1484-93Liquid Dosage Compositions of Stable Nanoparticulate
Active Agents
    
    *
    
    **
    
    **
    
    **
    
    **
    
    *Low Viscosity Liquid Dosage Forms
    
    *
    
    **
    
    **
    
    **
    
    **
    
    *System and Method for Milling Materials
    
    U.S.
    
    U.S. Patent No. 6,742,734
 
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Title of Invention
    
    Country
    
    Patent/Appln. No.*
    
    **
    
    **
    
    **
    
    **
    
    *Surface Modified Anticancer Nanoparticles
    
    U.S.
    
    Patent No. 5,399,363Canada
    
    Patent No. 2098242Europe
    
    Patent No. EP 577215*
    
    *Mexico
    
    Patent No. 205097Norway
    
    Patent No. 308193Taiwan
    
    Patent No. NI-079294
 
  Page 37




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##### 



SCHEDULE 2 ENTREMED PATENTS
 Serial No./
    
    Issue Date/Title
    
    Country
    
    Appl Type/Status
    
    Filing Date
    
    Patent No.Estrogenic Compounds as
    
    US
    
    Parent
    
    8/6/1993
    
    4/2/1996Anti-Mitotic Agents
    
    05213-0190
    
    Issued
    
    08/102,767
    
    5,504,074Estrogenic Compounds as
    
    Canada
    
    Natl Phase-PCT
    
    2/5/1996Anti-Mitotic Agents
    
    05213-0190CA
    
    Pending
    
    2,168,850Estrogenic Compounds as
    
    EPO
    
    Natl Phase-PCT
    
    2/23/1996Anti-Mitotic Agents
    
    05213-0190EP
    
    Issue Fee Paid
    
    94924120.2Estrogonic Compounds as
    
    Hong Kong
    
    Natl Phase-PCT
    
    12/28/1998Anti-Mitotic Agents
    
    05213-0190HK
    
    Pending
    
    98115897.5Estrogenic Compounds as
    
    Japan
    
    Nat Phase PCT
    
    2/6/1996Anti-Mitotic Agents
    
    05213-0190JP
    
    Pending
    
    506502/95Estrogenic Compounds as
    
    US
    
    Continuation
    
    12/12/1995
    
    8/26/1997Anti-Mitotic Agents
    
    05213-0191
    
    Issued
    
    08/571,265
    
    5,661,143Estrogenic Compounds as
    
    EPO
    
    Division
    
    8/1/2005Anti-Mitotic Agents
    
    05213-0191EP
    
    Pending
    
    05016659.4Estrogenic Compounds as
    
    US
    
    Division
    
    4/25/1997
    
    4/6/4999Anti-Mitotic Agents
    
    05213-0192
    
    Issued
    
    08/838,699
    
    5,892,069
 
  Page 38




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SCHEDULE 3 TECHNOLOGICAL COMPETITORS
 
  Page 39




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##### 



SCHEDULE 4 COMMERCIAL UNIT DOSE COST OF GOODS PRICING
 Commercial Product Cost of Goods per 1000mg unit dose
 **                    r
    
    *
    
    *
    
    *
    
    **
    
    *
    
    *
    
    *
    
    **
    
    *
    
    *
    
    *
    
    **
    
    *
    
    *
    
    *
    
    **
    
    *
    
    *
    
    *
    
    *
     
 *
    
    The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.




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##### 



SCHEDULE 5
 KEY TERMS FOR MANUFACTURING AND SUPPLY AGREEMENT
 1.
    
    EPIL to be the sole and exclusive supplier of Product to EntreMed in the Territory for
commercial
supplies._________________*.2.
    
    EPIL to own and be responsible for (i) filing regulatory approvals in regard to EPIL
Technology, (ii) DMFs that EPIL or its Affiliates may file in respect of EPIL Technology and
the application of EPIL Technology as regards the Product and/or the manufacture of Product,
and (iii) all necessary manufacturing approvals for the commercial manufacture of the Product.
EntreMed to be responsible for filing for and maintaining all other necessary Regulatory
Approvals, including for the manufacture of the Compound and any necessary export or import
licenses in relation to the Compound and/or the Product. For the avoidance of doubt, EntreMed
shall own and be responsible for the NDA and all other applications for regulatory approval
for the Product.3.
    
    EPIL to supply Product that is manufactured in accordance with and conforms
to agreed specifications and to all applicable laws and regulations for
supply and manufacturing, including cGMP. Product to be provided * bulk
packaging. Product packaging to conform to written standards that are to be
agreed by the Parties.4.
    
    EntreMed to supply Compound on time, free of charge * EPILs facility
and in sufficient quantities to enable EPIL to meet firm purchase orders. Compound to (i) conform to
specifications, (ii) be accompanied by a certificate of analysis, and (iii) be supplied, packaged and
labeled in accordance with EPIL requirements that are to be set out in a quality agreement (Quality
Agreement) to be negotiated in good faith between the Parties in relation to the commercial manufacture and
supply of Product. The Quality Agreement will also address issues
related
*.5.
    
    Detailed forecasting, ordering and delivery provisions to be negotiated in good faith between
the Parties and to be fully set out in Manufacturing and Supply Agreement.6.
    

The Parties to
establish                                                                *7.
    
    Until the * anniversary of the date that the Product is provided for commercial
use in Territory, the price per unit of Product to be as 
per
Schedule 4,
 *.
To the extent that the characteristics of final Product vary from the Product as specified on Schedule 4,
the price 
will be as
 per Schedule 4 adjusted as is reasonably and directly commensurate to such variance *.
Price increases shall be
*, 
although.8.
    
    EntreMed to have right to review and approve proposed changes in advance of their
implementation specific to the Product manufacturing, testing, or controls documentation which
require prior Regulatory Authority approval as well as any other changes that may be specified
as requiring EntreMed approval in the Quality Agreement.9.
    
    EntreMed to have * consent for EPIL use of Third Party subcontractors. EntreMed to also
have right to audit EPIL and subcontractors relevant to the Product manufacturing and testing no more
than * per calendar year, unless for cause.10.
    
    EPIL to manufacture and supply commercial Product to EntreMed through the EPIL facility located in
Athlone, Ireland. Within * after the first commercial sale of Product, * a second
 
 *
    
    The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.




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##### 



manufacturing facility
*
that can manufacture and supply commercial Product in accordance
with specifications, cGMPs and all relevant regulatory laws. * to be responsible for the
costs of the process transfer to * manufacturing facility in anticipation of the commercial
scale-up of the Product
*
 and for the costs of process transfer, validation and maintenance
*.

Site transfers requested by * from and after the NDA filing other than those mentioned above
shall be subject to reasonable prior consent and shall be at * cost.11.
    
    EntreMed to order safety stock through agreed order and forecast procedures.
*.12.
    
    EPIL to identify Third Parties that are reasonably acceptable to EntreMed for purposes of granting a
Manufacturing License in the event of a failure to supply, an event that will be negotiated in good
faith and defined by the Parties in the Manufacturing and Supply Agreement. The cost of such technology transfer
shall be borne by *.13.
    
    Release and rejection provisions (e.g., defects and latent defects) reasonably acceptable to
the Parties, with EPIL to have a specified time (e.g.,* days) rectify the issue.
EntreMed to be refunded where Product cannot be reworked or replaced within specified time,
although Parties agree that EntreMed shall not be entitled to a refund where non-conformity is
due to the supply of defective Compound or where the noncomformity is otherwise attributable
to the negligent acts or omissions EntreMed.14.
    
    *to be responsible for coordinating any Product recall and ensuring that
recalls are conducted in a commercially reasonable manner. Costs of recall shall be borne by
EntreMed unless (i) the recall arises from EPILs failure to supply Product in accordance with
agreed specifications and cGMP or from the negligent acts or omissions of EPIL in
manufacturing the Product or from EPILs breaches of the Manufacturing and Supply Agreement
*.15.
    
    EPIL responsible for compliance to cGMP and applicable laws for supply and manufacture,
adherence to specifications and indemnifications resulting from its breach thereof. EntreMed
responsible for marketing and promotion, and for recalls and indemnification arising
otherwise. Indemnification provisions will correspond to such responsibilities.16.
    
    Term of the manufacture and supply agreement will be the Term of the License Agreement.
 
 *
    
    The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.