Document:

exv10w1

 

Exhibit 10.1

EXECUTION COPY

ELAN PHARMA INTERNATIONAL

LIMITED

AND

ENTREMED, INC.

 

LICENSE AGREEMENT

 

 

 

INDEX

	 	 	 	 	 	 	 
	1.

	 	Definitions and Interpretation
	 	 	1	 
	2.

	 	The License
	 	 	7	 
	3.

	 	Intellectual Property
	 	 	8	 
	4.

	 	Non-Competition
	 	 	15	 
	5.

	 	Registration, Marketing and the Promotion of the Product
	 	 	15	 
	6.

	 	Financial Provisions
	 	 	15	 
	7.

	 	Manufacture and Supply
	 	 	18	 
	8.

	 	Payments, Reports and Audits
	 	 	19	 
	9.

	 	Duration and Termination
	 	 	19	 
	10.

	 	Consequences of Termination
	 	 	21	 
	11.

	 	Warranties, Indemnification and Liability
	 	 	22	 
	12.

	 	Confidentiality
	 	 	25	 
	13.

	 	Miscellaneous Provisions
	 	 	26	 
	Schedule 1

	 	EPIL Patents
	 	 	31	 
	Schedule 2

	 	EntreMed Patents
	 	 	39	 
	Schedule 3

	 	Technological Competitors
	 	 	40	 
	Schedule 4

	 	Commercial Unit Dose Cost of Goods Pricing
	 	 	41	 
	Schedule 5

	 	Key Terms for Manufacturing and Supply Agreement
	 	 	42	 
	 
	 	 	 	 	 	 
	i

 

 

THIS LICENSE AGREEMENT is dated January 9, 2006

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:

The Parties agree as follows:

	1.	 	DEFINITIONS AND INTERPRETATION
	 
	1.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 1

 

	 	 	“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:
	 
	 	 	
	 
	 	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 1

 

	 	 	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,

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 2

 

	 	 	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; and
	 
	 	 	as 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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 3

 

	 	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 4

 

	 	 	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 5

 

	 	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 6

 

	 	 	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; and
	 
	 	1.3.4	 	the expressions “include”, “includes”, “including”, “in particular” and
similar expressions shall be construed without limitation.

	2.	 	THE LICENSE
	 
	2.1.	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 7

 

	 	 	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 PROPERTY
	 
	3.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 8

 

	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; or
	 
	 	3.4.2.2	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 9

 

	 	 	 	(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); and
	 
	 	3.4.4.2	 	    *    % (    *     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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 10

 

	 	 	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 11

 

	 	 	 	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; and
	 
	 	3.5.8.5	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and
filed separately with the Securities Exchange Commission.

Page 12

 

	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 13

 

threatened in respect of the use or registration of the EPIL Trademark.
Any such proceedings shall be conducted at EPIL’s expense and for its
own benefit.

	4.	 	NON-COMPETITION

In order to provide adequate protection of EPIL Know-How, EPIL Confidential Information and EPIL
Highly Confidential Information, EntreMed and its Affiliates shall not develop, market or sell in
combination with a Technological Competitor any     *     formulation containing the
Compound, other than the Product: (i) in the EEA for a period of     *     beginning on the date of
first In Market sale of the Product in the EEA, or (ii) elsewhere in the Territory     *     .

	5.	 	REGISTRATION, MARKETING AND THE PROMOTION OF THE PRODUCT
	 
	5.1.	 	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; and
	 
	 	5.2.2	 	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; and
	 
	 	5.3.2	 	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; and
	 
	 	5.4.2	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 14

 

First Pivotal Study. EntreMed also shall promptly notify EPIL in writing of (i) the
submission date of all Regulatory Applications, (ii) the date that all such submissions are
accepted for filing by the relevant RHA, where applicable, and (iii) the date of all
Regulatory Approvals.

Following the first Regulatory Approval of the Product in a country in the Territory, the
Parties shall meet as often as reasonably requested by the other (not more than once per
calendar quarter). At such meetings, EntreMed shall report on the ongoing sales performance
of the Product in each country of the Territory,                         *                
                                
                                 for the next quarterly
period. Such meetings may be held by telephone. If held in person, each Party shall be
responsible for its own costs in respect of travel and accommodation expenses in attending
such meetings.

	6.	 	FINANCIAL PROVISIONS
	 
	6.1.	 	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     *    

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 15

 

    *    , (ii) notification by the FDA that the FDA waives the
PAI,
                              *                                                    
                  
                  
                                              
       ;

	 	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               *               ; and
	 
	 	6.1.13	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 16

 

commonly known in the pharmaceutical industry as “bundling”), then for the purposes of
determining the Net Sales of the Product,             *             . The Net Sales of such permitted
bundled products (meaning the combined price at which the Product and other product(s) are
sold) will be multiplied by a fraction, the numerator of which is standard price for the
Product multiplied by the number of units of Product sold in the bundled products and the
denominator of which is the numerator plus the sum of the standard prices of the other
products in the product bundle multiplied by the number of units of these products sold as
part of the product bundle.

For the avoidance of doubt, in the event that EntreMed, its Affiliates or a permitted Third
Party sub-licensee sells the Product with other products which (i) are not prescription
products and/or (ii) which are generic products, and the price attributable to the Product
is less than the average price of “arms length” sales to similar customers for the reporting
period in which sales occur (such sales to be excluded from the calculation of the average
price of “arms length” sales), Net Sales for any such sales shall be             *             .

	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 SUPPLY 
	 
	7.1.	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 17

 

written consent of EPIL which shall not be unreasonably withheld or delayed, EntreMed shall
have the right to grant a sub-license of the Manufacturing License             *            
                        
                        
                        
                         .
Additionally, in the event that EntreMed, or as the case may be, the sub-licensee of the
Manufacturing License entrusted with the manufacture of the Product (either, the “Designated
Manufacturer”) becomes 
            *            
                        
                        
                        
                        
 the Designated Manufacturer shall not be entitled to
exercise manufacturing rights hereunder (or under the sub-license of the Manufacturing
License, as applicable) or if manufacturing rights were previously exercised prior to the
event in question such manufacturing rights shall automatically revert to EPIL. In either
event, EPIL and EntreMed (or             *             ) shall co-operate in good faith to locate an
independent Third Party manufacturer who is not             *             and is capable of manufacturing the Product.

	8.	 	PAYMENTS, REPORTS AND AUDITS 
	 
	8.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 18

 

	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; and
	 
	 	8.6.2	 	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 TERMINATION
	 
	9.1.	 	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; or
	 
	 	9.1.2	 	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”),

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 19

 

unless the Agreement has been terminated by     *     by serving one (1) year’s written notice
    *     immediately prior to the end of the Initial Term or any such additional Extended Term

	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; or
	 
	 	9.4.4	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 20

 

Regulatory Application, EPIL will consider in good faith whether or not it deems it
appropriate to exercise such right of termination;

	 	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 TERMINATION
	 
	10.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 21

 

	 	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 LIABILITY
	 
	11.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 22

 

	 	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; and
	 
	 	11.7.4	 	take all reasonable steps to mitigate any loss or liability in respect of any such
Claim or proceedings.

The indemnifying Party may settle a Claim on terms which provide only for monetary relief
and do not include any admission of liability. Save as aforesaid, neither the indemnifying
Party nor the Party to be indemnified shall acknowledge the validity of, compromise or
otherwise settle any Claim without the prior written consent of the other, which shall not
be unreasonably withheld.

	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 23

 

FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE
EXPRESSLY DISCLAIMED TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS.

	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.	 	CONFIDENTIALITY
	 
	12.1.	 	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; or
	 
	 	12.2.4	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 24

 

obligations or exercising its rights under this Agreement or Related Agreements and for no
other purpose.

	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 25

 

the terms of the Agreement that have already been publicly disclosed in the initial press release(s) but in no circumstance may
either Party disclose any other information regarding the existence, subject matter, or any term of this Agreement (such as
confidential information or commercially sensitive information on financial terms) or its performance, without the prior
written consent of the other.

	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; or
	 
	 	 	12.14.2     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 PROVISIONS
	 
	13.1.	 	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.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 26

 

	 	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/or
	 
	 	13.2.1.2	 	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

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 27

 

or by law prevents further exercise of the right or remedy or the exercise of another right
or remedy.

	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; and
	 
	 	13.11.1.2	 	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 Limited
	 

	 	 	 	Monksland	 	 	 	 	 	 
	 

	 	 	 	Athlone	 	 	 	 	 	 
	 

	 	 	 	Co. Westmeath	 	 	 	 	 	 
	 

	 	 	 	Ireland	 	 	 	 	 	 
	 
	 

	 	Fax:
	 	+353 90 649 2427	 	 	 	 	 	 
	 	 	Marked for the attention of :	 	Vice President and General Counsel	 	 	 	 
	 

	 	 	 	 	 	Elan Drug Technologies	 	 	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with
the Securities Exchange Commission.

Page 28

 

	 	(b)	 	in the case of EntreMed:

	 	 	 	 	 	 	 
	 

	 	Address:
	 	EntreMed, Inc.	 	 
	 

	 	 	 	9640 Medical Center Drive	 	 
	 

	 	 	 	Rockville, MD 20850	 	 
	 
	 

	 	Fax:
	 	+1 240 864 2624	 	 
	 	 	Marked 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.

***

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 29

 

SIGNED

/s/ Elan Pharma International Limited

Duly authorised for and on behalf of:

ELAN PHARMA INTERNATIONAL LIMITED

SIGNED

/s/ EntreMed, Inc.

Duly authorised for and on behalf of:

ENTREMED, INC.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 30

 

SCHEDULE 1               EPIL PATENTS

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	Surface Modified Drug Nanoparticles
	 	U.S.	 	5,145,684
	 
	 	 	 	 
	 
	 	EU	 	EP 499299
	 
	 	 	 	 
	 
	 	Argentina	 	AR 255241
	 
	 	 	 	 
	 
	 	Australia	 	654836
	 
	 	 	 	 
	 
	 	Canada	 	2,059,432
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Columbia	 	24635
	 
	 	 	 	 
	 
	 	Finland	 	108333
	 
	 	 	 	 
	 
	 	Hungary	 	221,586
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Israel	 	100754
	 
	 	 	 	 
	 
	 	Japan	 	92/11226
	 
	 	 	 	 
	 
	 	S. Korea	 	200061
	 
	 	 	 	 
	 
	 	Malaysia	 	MY-108134-A
	 
	 	 	 	 
	 
	 	Mexico	 	176345
	 
	 	 	 	 
	 
	 	New Zealand	 	241362
	 
	 	 	 	 
	 
	 	Norway	 	303668
	 
	 	 	 	 
	 
	 	Philippines	 	29069
	 
	 	 	 	 
	 
	 	Russia	 	2066553
	 
	 	 	 	 
	 
	 	Singapore	 	55104
	 
	 	 	 	 
	 
	 	Taiwan	 	NI-071312
	 
	 	 	 	 
	Solid Dose Nanoparticulate Compositions Comprising a
Synergistic Combination of a Polymeric Surface Stabilizer
and Dioctyl Sodium Sulfosuccinate
	 	U.S.	 	6,375,986
	 
	 	 	 	 
	 
	 	*	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 31

 

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	Nanoparticulate dispersions comprising a synergistic
combination of a polymeric surface stabilizer and dioctyl
sodium sulfosuccinate
	 	U.S.	 	6,592,903
	 
	 	 	 	 
	Nanoparticulate Compositions of Angiogenesis Inhibitors
	 	U.S.	 	10/392,403
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Japan	 	2003-577857
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	Redispersible Nanoparticulate Film Matrices With
Protective Overcoats
	 	U.S.	 	5,573,783
	 
	 	 	 	 
	 
	 	Canada	 	2,212,803
	 
	 	 	 	 
	 
	 	Europe	 	EP 812187
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	Continuous Method of Grinding Pharmaceutical Substances
	 	U.S.	 	5,718,388
	 
	 	 	 	 
	 
	 	Argentina	 	Patent No. AR 253558 V1
	 
	 	 	 	 
	 
	 	Canada	 	Patent. No. 2,190,134
	 
	 	 	 	 
	 
	 	Taiwan	 	Patent No. NI-122518
	 
	 	 	 	 
	 
	 	Europe	 	EP 804161
	 
	 	 	 	 
	 
	 	Israel	 	Patent No. 113851
	 
	 	 	 	 
	 
	 	Japan	 	Patent No. 3607294
	 
	 	 	 	 
	 
	 	Malaysia	 	Patent No. MY-113,569-A
	 
	 	 	 	 
	 
	 	Philippines	 	Patent No. 31497
	 
	 	 	 	 
	 
	 	Venezuela	 	Patent No. 0854/95
	 
	 	 	 	 
	Method of Grinding Pharmaceutical Substances
	 	U.S.	 	5,862,999
	 
	 	 	 	 
	 
	 	Argentina	 	Patent No. AR 254497 V1
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Taiwan	 	Patent No. NI-112433
	 
	 	 	 	 
	 
	 	Europe	 	EP 760653

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 32

 

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 
	 	Israel	 	Patent No. 113852
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Malaysia	 	Patent No. MY-112,458-A
	 
	 	 	 	 
	 
	 	Philippines	 	Patent No. 1-1995-50573
	 
	 	 	 	 
	 
	 	Venezuela	 	Patent No. 0853-95
	 
	 	 	 	 
	Methods for Preventing Crystal Growth and Particle
Aggregation in Nanoparticle Compositions
	 	U.S.	 	6,267,989
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Canada	 	Patent No. 2,367,096
	 
	 	 	 	 
	 
	 	Europe	 	EP 1161229
	 
	 	 	 	 
	Process of Preparing Therapeutic Compositions Containing
Nanoparticles
	 	U.S.	 	5,510,118
	 
	 	 	 	 
	Use of Ionic Cloud Point Modifiers to Prevent Particle
Aggregation During Sterilization
	 	U.S.	 	5,298,262
	 
	 	 	 	 
	Use of Non-Ionic Cloud Point Modifiers to Minimize
Nanoparticulate Aggregation During Sterilization
	 	U.S.	 	5,346,702
	 
	 	 	 	 
	Use of Purified Surface Modifiers to Prevent Particle
Aggregation During Sterilization
	 	U.S.	 	5,352,459
	 
	 	 	 	 
	 
	 	Argentina	 	Patent No. AR 255267 V1
	 
	 	 	 	 
	 
	 	Mexico	 	Patent No. 190632
	 
	 	 	 	 
	Method of Preparing Stable Drug Nanoparticles
	 	U.S.	 	5,534,270
	 
	 	 	 	 
	Formulations of Compounds as Nanoparticulate Dispersions
in Digestible Oils or Fatty Acids
	 	U.S.	 	5,571,536
	 
	 	 	 	 
	 
	 	U.S.	 	5,560,931
	 
	 	 	 	 
	 
	 	Europe	 	EP 808154
	 
	 	 	 	 
	Microprecipitation of Nanoparticulate Pharmaceutical Agents
	 	U. S.	 	5,560,932
	 
	 	 	 	 
	Pharmaceutical Compositions Containing Polyalkylene Block
Copolymers Which Gel at Physiological Temperature
	 	U.S.	 	5,565,188
	 
	 	 	 	 
	 
	 	U.S.	 	5,705,194
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Europe	 	EP 810855

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 33

 

\

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 
	 	*	 	*
	 
	 	 	 	 
	Sulfated Non-Ionic Block Copolymer Surfactant as
Stabilizer Coatings for Nanoparticle Compositions
	 	U.S.	 	5,569,448
	 
	 	 	 	 
	Formulations of Oral Gastrointestinal Therapeutic Agents
in Combination with Pharmaceutically Acceptable Clays
	 	U. S.	 	5,585,108
	 
	 	 	 	 
	Butylene Oxide-Ethylene Oxide Block Copolymer Surfactants
as Stabilizer Coatings for Nanoparticle Compositions
	 	U.S.	 	5,587,143
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Europe	 	EP 804162
	 
	 	 	 	 
	 
	 	Israel	 	Patent No. 114354
	 
	 	 	 	 
	 
	 	Japan	 	Patent No. 3710811
	 
	 	 	 	 
	Sugar Based Surfactant for Nanocrystals
	 	U.S.	 	5,622,938
	 
	 	 	 	 
	Microprecipitation of Nanoparticulate Pharmaceutical
Agents Using Surface Active Material Derived From Similar
Pharmaceutical Agents
	 	U.S.	 	5,716,642
	 
	 	 	 	 
	Use of PEG-Derivatized Lipids as Surface Stabilizers for
Nanoparticle Compositions
	 	U.S.	 	6,270,806
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Canada	 	Patent No. 2,362,508
	 
	 	 	 	 
	 
	 	Europe	 	EP 1156788
	 
	 	 	 	 
	Controlled Release of Nanoparticle Compositions
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	Bioadhesive Nanoparticle Compositions Having Cationic
Surface Stabilizers
	 	US	 	6,428,814
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Europe	 	EP 1217993
	 
	 	 	 	 
	Small Scale Mill and Method Thereof
	 	US	 	6,431,478

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 34

 

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 
	 	US	 	6,745,962
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	Europe	 	EP 1185371
	 
	 	 	 	 
	Rapidly 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
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*
	 
	 	 	 	 
	 
	 	*	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the
Securities Exchange Commission.

Page 35

 

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 	*	 	*
	 
	Fast Dissolving Dosage Forms Having Reduced Friability
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	Method of Grinding Pharmaceutical Substances
	 	U.S.	 	5,518,187
	 
	 
	 	Argentina	 	Patent No. 251001
	 
	 
	 	Australia	 	Patent No. 660852
	 
	 
	 	*	 	*
	 
	 
	 	Taiwan	 	Patent No. NI-69476
	 
	 
	 	Czech Republic	 	Patent No. 284802
	 
	 
	 	Europe	 	Patent No. EP 600528
	 
	 
	 	Finland	 	Patent No. 108399
	 
	 
	 	Hungary	 	Patent No. 210928
	 
	 
	 	*	 	*
	 
	 
	 	South Korea	 	Patent No. 312798
	 
	 
	 	Malaysia	 	Patent No. MY-109,419-A
	 
	 
	 	Mexico	 	Patent No. 189779
	 
	 
	 	New Zealand	 	Patent No. 248813
	 
	 
	 	*	 	*
	 
	 
	 	Philippines	 	Patent No. 31118
	 
	 
	 	Slovak Republic	 	Patent No. 281078
	 
	 
	 	*	 	*
	 
	 
	 	Venezuela	 	Patent No. 1484-93
	 
	Liquid 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
	 

 

* The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 36

 

	 	 	 	 	 
	Title of Invention	 	Country	 	Patent/Appln. No.
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	 
	 	*	 	*
	 
	Surface Modified Anticancer Nanoparticles
	 	U.S.	 	Patent No. 5,399,363
	 
	 
	 	Canada	 	Patent No. 2098242
	 
	 
	 	Europe	 	Patent No. EP 577215
	 
	 
	 	*	 	*
	 
	 
	 	Mexico	 	Patent No. 205097
	 
	 
	 	Norway	 	Patent No. 308193
	 
	 
	 	Taiwan	 	Patent No. NI-079294
	 

 

* The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 37

 

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	 	4/2/1996
	Anti-Mitotic Agents
	 	05213-0190	 	Issued	 	08/102,767	 	5,504,074
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	Canada	 	Nat’l Phase-PCT	 	2/5/1996	 	 
	Anti-Mitotic Agents
	 	05213-0190CA	 	Pending	 	2,168,850	 	 
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	EPO	 	Nat’l Phase-PCT	 	2/23/1996	 	 
	Anti-Mitotic Agents
	 	05213-0190EP	 	Issue Fee Paid	 	94924120.2	 	 
	 
	 	 	 	 	 	 	 	 
	Estrogonic Compounds as
	 	Hong Kong	 	Nat’l Phase-PCT	 	12/28/1998	 	 
	Anti-Mitotic Agents
	 	05213-0190HK	 	Pending	 	98115897.5	 	 
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	Japan	 	Nat Phase PCT	 	2/6/1996	 	 
	Anti-Mitotic Agents
	 	05213-0190JP	 	Pending	 	506502/95	 	 
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	US	 	Continuation	 	12/12/1995	 	8/26/1997
	Anti-Mitotic Agents
	 	05213-0191	 	Issued	 	08/571,265	 	5,661,143
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	EPO	 	Division	 	8/1/2005	 	 
	Anti-Mitotic Agents
	 	05213-0191EP	 	Pending	 	05016659.4	 	 
	 
	 	 	 	 	 	 	 	 
	Estrogenic Compounds as
	 	US	 	Division	 	4/25/1997	 	4/6/4999
	Anti-Mitotic Agents
	 	05213-0192	 	Issued	 	08/838,699	 	5,892,069

 

* The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 38

 

SCHEDULE 3 TECHNOLOGICAL COMPETITORS

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

 

* The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 39

 

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.

 

 

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.

 

 

	 	 	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.exv10w2

 

Exhibit
10.2

RESEARCH, DEVELOPMENT

AND COMMERCIALIZATION AGREEMENT

     This Research, Development and Commercialization Agreement (“Agreement”) is
entered into as of this 20th day of April, 2005, by and between:

     on the one hand,

Hoffmann-La Roche Inc., a corporation organized and existing under the laws of the State of New
Jersey, with its principal place of business at 340 Kingsland Street, Nutley New Jersey 07110
(“Roche Nutley”), and F.Hoffmann-La Roche Ltd, a Swiss corporation, with its principal
office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”; Roche Nutley
and Roche Basel are collectively referenced as “Roche”),

     and on the other hand,

     Miikana Therapeutics Inc., a corporation organized and existing under the laws of the State of
California, with its principal place of business at 6519 Dumbarton Circle, Fremont, CA 94555 USA
(“Miikana”). Miikana and Roche each may be referred to herein as a “Party,” and
collectively as “Parties.’

     WHEREAS, Roche owns or possesses certain patent rights, know-how and regulatory filings with
respect to various orally active cell cycle inhibitors (“CCI”), including the CCI compounds known
as     *    ;

     WHEREAS, Roche believes that     *     and related compounds have the potential to become a
drug with significant worldwide annual sales, and that Miikana has the ability to realize the
potential of certain of these compounds;

     WHEREAS, Miikana desires to develop     *     , and/or     *     and ensure that it is
diligently developed and commercialized worldwide so as to realize promptly its therapeutic and
commercial potential;

     WHEREAS, Miikana desires to obtain rights from Roche so that Miikana, either on its own
    *     , and/or     *     and realizes its therapeutic and commercial potential;

     WHEREAS, Miikana desires to obtain an exclusive license under Roche’s patent rights, know-how
and regulatory filings to begin development and commercialization     *     ,     *     and/or
    *     ; and

     WHEREAS, Roche is willing to grant an exclusive license to Miikana under such patent rights
and know-how.

     NOW THEREFORE, in consideration of the foregoing and of the mutual covenants hereinafter set
forth and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties mutually agree as follows:

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

 

 

ARTICLE 1

DEFINITIONS

     As used in this Agreement, the following terms shall have the following meanings, and singular
forms, plural forms and derivative forms, (i.e. other parts of speech) shall be interpreted
accordingly:

     1.1 “Affiliate” means any corporation or non-corporate business entity that directly
or indirectly controls, is controlled by, or is under common control with a Party to this
Agreement. As used in this definition, the term “control” (with correlative meanings for the
terms “controlled by” and “under common control with”) means that an entity owns greater than fifty
percent (>50%) of the voting stock of the subject entity with the ability to elect a majority of
the board (or managing members) of such entity, or otherwise has the power to govern and control
the financial and the operating policies and management of the subject entity, whether through the
ownership or control of voting securities, by contract or otherwise. With respect to Roche, the
term “Affiliate” shall not include Genentech, Inc., nor Chugai Pharmaceutical Co., Ltd, unless
Roche opts for such inclusion by giving written notice to Miikana.

     1.2 “Combination Product” means a finished product containing a Compound or Derivative
in combination with one or more other active pharmaceutical ingredients, devices, equipment or
components that are not themselves Licensed Products.

     1.3 “Commencement” means, with respect to a clinical trial, the date upon which the
first patient receives the first dose of an item that is the subject of such clinical trial.

     1.4 “Commercialize” means to make, have made, develop, use, sell, have sold, offer for
sale, and import.

     1.5 “Compound” means (a) the compound known as     *     and/or           , or (b) any compound
that is a salt, ester or polymorph of     *     and/or     *    .

     1.6 “Controlled” means, with respect to Know-How or patents, that the applicable Party
has licensed (or otherwise obtained rights to or under) such Know-How or patents from a Third Party
and such Party has the right to grant sublicenses to such Know-How or patents.

     1.7 “Derivative” means a metabolite, prodrug or regioisomer     *     and     *    
that is claimed, generically or specifically, in the Roche Patent Rights.

     1.8 “Development Plan” means the model plan for guiding the development of Licensed
Products, the first draft of which is set forth in Appendix C.

     1.9 “Dollars” or “$” means US dollars.

     1.10 “Effective Date” means the date first mentioned above.

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-2-

 

     1.11 “FDA” means the United States Food and Drug Administration and any successor
entity thereto.

     1.12 “FD&C Act” means the US Federal Food, Drug and Cosmetic Act, as amended, and the
equivalent laws and regulations in any foreign countries or jurisdictions.

     1.13 “Field” means all therapeutic, prophylactic, and other pharmaceutical uses,
applications and indications.

     1.14 “First Commercial Sale” means the first sale of a Licensed Product in a
particular country to a Third Party following its approval for marketing and sale by the applicable
Regulatory Agency in such country.

     1.15 “Global Alliance Director” means an employee of Roche who is selected by Roche to
be the point person with primary responsibility for communications and interactions with Miikana.

     1.16 “IND” means an Investigational New Drug Application filed with the FDA and
covering administration of a Compound or Derivative.

     1.17 “Inventions” means any and all useful ideas, concepts, methods, procedures,
processes, improvements, inventions, discoveries, and reductions to practice, whether or not
patentable, which arise from or are first made, conceived or first reduced to practice in the
course of the activities conducted pursuant to or in exercise of a right granted under this
Agreement.

     1.18 “Know How” means all non-patented data, information, methods, procedures,
processes, materials and other know-how. Know-How includes but is not limited to: biological,
chemical, biochemical, toxicological, pharmacological, metabolic, formulation, clinical,
regulatory, manufacturing, analytical and stability information and data (other than such
information and data which is or becomes the subject of a patent or patent application).

     1.19 “Licensed Product” means any product containing a Compound or a Derivative,
including all formulations, dosages, and dosage forms thereof.

     1.20 “Maior Market” means any of the     *     .

     1.21 Miikana Group” means Miikana, its Affiliates and sublicensees under this
Agreement.

     1.22 “Miikana Know-How” means all Know-How that is related to the Compound, a
Derivative, or a Licensed Product, and is owned or Controlled by the Miikana Group and in which the
Miikana Group has a transferable interest.

     1.23 “Miikana Patent Rights” means all Patents in the Territory that (a) claim a
Compound, Derivative or Licensed Product, or the manufacture or use thereof, and (b) are owned or
Controlled by Miikana or any of its Affiliates during the term of this Agreement.

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-3-

 

     1.24 “NDA” means a New Drug Application accepted for filing with a Regulatory Agency
for a Compound or Derivative.

     1.25 “Net Sales” means, with respect to Miikana, the amount of gross sales of all
Licensed Products in the Territory invoiced by the Miikana Group to Third Parties, as reduced by
the following deductions to the extent actually allowed or incurred with respect to such sales: (a)
transportation charges, and other shipping charges, such as insurance, (b) sales, value-added and
excise taxes, customs, duties, and any other governmental charges, to the extent imposed upon the
sale of the Licensed Product and paid by the selling party, provided that no income taxes shall be
deducted from gross sales of Licensed Product to calculate Net Sales, (c) distributors fees,
rebates or allowances actually granted or allowed, including government and managed care rebates,
(d) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred, (e)
allowances or credits to customers, not in excess of the selling price of Licensed Product, on
account of governmental requirements, rejections, recalls or returns, and (f) allowances for bad
debt actually documented to have occurred solely as a result of sale of the Licensed Product.

     If a Licensed Product is contained within a Combination Product then Net Sales for such
Combination Product, for purposes of calculating the royalties owed on sale of such Combination
Product, shall be reduced by multiplying Net Sales of such Combination Product (as determined
above) by the fraction A/(A+B) where A is the selling price of the Compound-containing unit if sold
separately and B is the selling price of the other active pharmaceutical ingredients, devices,
equipment or components in the Combination Product if sold separately. If the Compound-containing
unit or one or more of such active pharmaceutical ingredients, devices, equipment or components in
the Combination Product are not sold separately, then the parties shall negotiate in good faith a
formula for adjusting Net Sales to reflect the relative value of the contribution of the
Compound-containing unit to the total sales price of the Combination Product.

     1.26 “Patent” means (a) any patent, including re-examinations, reissues, renewals,
extensions and term restorations thereof, and any foreign counterpart of any of the foregoing, and
(b) any pending application for patent, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications, inventors’
certificates, and extensions, and any foreign counterpart of any of the foregoing.

     1.27 “Phase I” means, with respect to the United States, the first phase of human
clinical trials using a limited number of human subjects to gain evidence of the safety and
tolerability of a Licensed Product and information regarding pharmacokinetics and potentially
pharmacological activity for such Licensed Product, Compound or Derivative, which human clinical
trials are completed prior to the initiation of Phase II, as described in 21 C.F.R. § 312.21(a), as
may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a
clinical trial in such other country or jurisdiction.

     1.28 “Phase II” means, with respect to the United States, the second phase of human
clinical trials of a Licensed Product in human subjects to gain evidence of the efficacy in one or
more indications and expanded evidence of the safety of such Licensed Product, Compound or
Derivative, as well as an indication of the dosage regimen required, as described in

 

			
	*	 	The marked portions have been omitted pursuant to a request
for confidential treatment and filed separately with the Securities Exchange Commission.

-4-

 

21 C.F.R.§ 312.21(b), as may be amended, or, with respect to any other country or
jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.

     1.29 “Phase III` means, with respect to the United States, the third phase of
human clinical trials of a Licensed Product, which are large-scale trials to gain evidence of the
efficacy and safety in a number of human subjects sufficient to support Registration for such
Licensed Product, Compound or Derivative with the FDA, as described in 21 C.F.R. § 312.21(c), as
may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a
clinical trial in such other country or jurisdiction.

     1.30 “Registration” in relation to any Licensed Product means such approvals by the
applicable Regulatory Agency in a country (or community or association of countries) included in
the Territory (including, where applicable, price approvals) that are required to be obtained prior
to marketing and selling such Licensed Product in such country or jurisdiction.

     1.31 “Regulatory Agency” means, with respect to any particular country or
jurisdiction, the governmental authorities, bodies, commissions, agencies and/or other
instrumentalities of such country or jurisdiction (the EMEA with respect to the EU), with the
primary responsibility for the evaluation or approval of pharmaceutical products before such
product can be tested, marketed, promoted, distributed or sold in such country, including such
governmental bodies that have jurisdiction over the conduct of clinical trials and/or the pricing
of such pharmaceutical product. The term “Regulatory Agency” includes the FDA.

     1.32 “Regulatory, Filing means any filing with a Regulatory Agency relating to or to
permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product.
Regulatory Filings include without limitation INDs and NDAs.

     1.33 “Roche Know-How” means all Know-How which on the Effective Date is owned or
Controlled by Roche and in which Roche has a transferable interest.

     1.34 “Roche Patent Rights” means all Patents in the Territory listed on Appendix A,
and any future Patents that claim priority from or the benefit of the filing date of any of the
patents and applications listed in Appendix A, and including any and all extensions, supplementary
protection certificates and the like with respect to any of the foregoing.

     1.35 “Territory” means the entire world, subject to Section 12.7(a).

     1.36 “Third Party” means any party other than Roche, Roche’s Affiliates, Miikana, or
Miikana’ Affiliates.

     1.37 “Transfer Know-How” means the Roche Know-How identified on Appendix B.

     1.38 “US” means the United States of America, its territories and possessions.

     1.39 “Valid Claim” means a claim contained in (i) an issued and unexpired patent
included within the Roche Patent Rights or Miikana Patent Rights that has not been held
unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of

 

			
	*	 	The marked portions have been omitted pursuant to a request
for confidential treatment and filed separately with the Securities Exchange Commission.

-5-

 

competent jurisdiction, which decision is not subject to any further appeal, and that has not
been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise
or (ii) a patent application which is included within the Roche Patent Rights or Miikana Patent
Rights and has been pending for less than     *     from
the priority date. If a claim of a patent application that ceased to be a Valid
Claim under item (ii) because of the passage of time later issues as a part of a patent
within item (i), then it shall again be considered to be a Valid Claim effective as of the issuance of such patent.

ARTICLE 2

GRANT OF LICENSE

     2.1 Grant. Subject to the terms and conditions of this Agreement, Roche hereby
grants to Miikana and its Affiliates, and Miikana hereby accepts on its and their behalf, a sole
and exclusive license, with full rights to sublicense as provided in Section 2.2, under the Roche
Patent Rights and Roche Know-How, to (a) develop, use, sell, offer for sale, and import Licensed
Products in the Territory, and (b) make and have made Licensed Products in the Territory for such
development, use, sale, offering for sale, and importation. Notwithstanding anything to the
contrary in this Section 2.1, Roche shall retain all rights under the Roche Patent Rights and Roche
Know How for any other purpose. Miikana’s rights to import in the Territory shall not include
    *     . Subject to the terms and conditions of this Agreement, Roche also grants to Miikana,
its Affiliates and sublicensees immunity from suit from Roche and its Affiliates under any Patent
owned or controlled by Roche or its Affiliates on the Effective Date, and any other Patent that
claims priority from or the benefit of the filing date of any of the foregoing Patents, with
respect to making, using, selling, offering for sale or importing of Licensed Product in a
formulation in existence as of the Effective Date (which includes without limitation any additional
dosages, dosage forms, and separate packagings thereof).

     2.2 Right to Sublicense. Miikana and its Affiliates shall have the right to
sublicense the rights granted under Section 2.1 to Third Parties (which will have no right to
further sublicense, except to the Affiliates of such Third Party sublicensees). If Miikana grants
such sublicenses, then all such sublicenses shall conform to and be in accordance with the terms of
this Agreement. Miikana assumes full responsibility for the performance of all obligations under
this Agreement and will remain obligated to Roche for all royalties due under this Agreement by
reason of the operations of any such sublicense.

     2.3 Covenant Regarding License Scope. Miikana hereby covenants and agrees that it
and its Affiliates shall not, during the term of this Agreement, knowingly practice any Roche
Patent Rights or Roche Know How outside the scope of the license granted by Roche in Section 2.1.

     2.4 Diligence. If Miikana has not
completed a     *     clinical trial within
___    *    ___years after the Effective Date with respect to any Licensed Product, then Roche may
terminate all licenses granted herein. Following such termination by Roche under this Section 2.4
    *    .

 

			
	*	 	The marked portions have been omitted pursuant to a request
for confidential treatment and filed separately with the Securities Exchange Commission.

-6-

 

ARTICLE 3

RESEARCH AND DEVELOPMENT REIMBURSEMENT AND MILESTONE

PAYMENTS

     3.1 Fees. Miikana shall pay to Roche in consideration for the rights granted herein
a fee which shall be non-refundable, and non-creditable, and shall consist of (a)     *                shares
of Miikana Series A Preferred stock, issued on the Effective Date pursuant to the Stock Purchase
Agreement attached hereto as Appendix E, and (b)     *     in cash, owing as of the Effective Date and
payable on or before the dates set forth below:

	 	 	 
	Time	 	Amount
	By the earlier of either (a) June 30, 2005, or (b) the closing date
of Miikana’s Series B Financing

	 	*
	 
	 	 
	By September 30, 2005

	 	*

Of the above, the     *                shares of Miikana Series A Preferred stock and Dollars
___    *    ___shall be issued and paid to F.Hoffmann-La Roche Ltd and the
remaining     *     Dollars ( $    *     ) shall be paid to Hoffmann-La Roche Inc.

     3.2 Milestone Payments. Miikana shall pay to Roche non-refundable, non-creditable
milestone payments in the amounts specified in tabular form below (each a “Milestone Payment”) no
later than     *     days after the first occurrence of each of the following events with respect
to each Licensed Product, as they occur:

	 	 	 
	Milestones	 	Payments (Dollars)
	Commencement Phase III

	 	*
	NDA Filing in the USA

	 	*
	NDA Filing outside the USA

	 	*
	First Commercial Sale in the USA

	 	*
	First Commercial Sale outside the USA

	 	*
	First time annual sales in the Territory exceed     *    

	 	*
	First time annual sales in the Territory exceed     *    

	 	*

All milestones payments set forth under this Section 3.2 shall be paid to Roche only once for a
given Licensed Product containing a particular Compound or particular Derivative, and once

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-7-

 

paid shall be non-refundable. For clarity, once any milestone payment is paid to Roche under this
Section 3.2 for a given Licensed Product, such payment shall not be owed with respect to any other
Licensed Product containing the same Compound or Derivative even if such milestone is subsequently
achieved again by the Licensed Product having a different dosage, dosage form, package,
formulation, modes of administration or intended indication. Of course, if another Licensed
Product has a different Compound or Derivative than the previous Licensed Product, then Miikana
shall pay to Roche the milestones set forth under this Section 3.2 with respect to such other
Licensed Product. If development of a Licensed Product is terminated prior to First Commercial
Sale of such Licensed Product, then Miikana may credit such milestone payments paid to Roche with
respect to such Licensed Product against milestone payments that become due for a subsequent
Licensed Product. The term “annual sales” shall mean Net Sales in a given calendar year.

ARTICLE 4

ROYALTIES

     4.1 Royalties in General. For each Licensed Product, the obligation of Miikana to
pay Roche royalties based on sales of the Licensed Product in a given country shall commence on the
date of the First Commercial Sale of such Licensed Product by the Miikana Group in such country and
shall continue until the     *     of (a) the date upon which there no longer exists in such
country a Patent within the Roche Patent Rights having a Valid Claim that claims the manufacture,
use or sale of such Licensed Product in such country, or (b) subject to Section 4.3, the date which
is       *     years after the date of First Commercial Sale of such Licensed Product in
such country. Miikana shall pay or cause to be paid to Roche a royalty based on Net Sales made by
the Miikana Group in the Territory, on a country-by-country basis, at the applicable incremental
royalty rate as provided for in the table below in this Section 4.1, subject to reduction as
provided in Section 4.3.

	 	 	 
	Total, Territory wide Annual Net Sales in a single calendar year	 	Royalty Rate
	Amount of Net Sales up to and including     *    

	 	*
	Amount of Net Sales over     *     and up to and including     *    

	 	*
	Amount of Net Sales over     *     and up to and including     *    

	 	*
	Amount of Net Sales over     *    

	 	*

     4.2 Accrual of Royalties. No royalty shall be due or owing from the use or
distribution of a Licensed Product in transactions where no consideration is received by the
Miikana Group, such as when a Licensed Product is made or used for tests or development purposes or
is distributed as samples. No royalties shall be payable on sales among entities within the
Miikana Group, but royalties shall be payable on subsequent sales by entities within the Miikana
Group to a Third Party. No multiple royalties shall be payable under this Agreement because a
commercialized Licensed Product is covered by more than one Valid Claim or is covered by both a
claim with respect to Know-Haw and a Valid Claim.

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-8-

 

     4.3 Reduction for Third Party Licenses.

          (a) If Miikana pays royalties, upfront fees or milestone payments to Third Parties pursuant to
intellectual property license agreements covering the manufacture, use or sale of Licensed Products
and negotiated at arm’s length, then Miikana may credit     *     of such payments paid to such
Third Parties against the amounts otherwise payable pursuant to Section 4.1.

          (b) Likewise, if no Patent within the Roche Patent Rights has a Valid Claim that claims the
manufacture, use or sale of such Licensed Product in a country, then Miikana may credit     *    
of the royalties otherwise due from sales in such country against the amounts otherwise payable
pursuant to Section 4.1.

          (c) The credit provided by Section 4.3(a) shall be effective only for Licensed Products sold
after any payments required by the licenses from such Third Parties are incurred. Miikana shall
provide Roche with written notice of such a requirement within     *     after it becomes
effective, and such notice shall include the name of the Third Party, the patents under which
payments are being paid to the Third Party, and the element of the Licensed Product to which the
third-party intellectual property applies. In no event shall royalties payable pursuant to
Section 4.1 be reduced, due to application of this Section 4.3, by more than     *     of the
amount that otherwise would be owed.

ARTICLE 5

ROYALTY REPORTS AND ACCOUNTING

     5.1 Royalty Payments; Royalty Reports. After the First Commercial Sale and for the
remaining term of this Agreement, Miikana shall submit with each payment of royalties to Roche a
written royalty report (“Royalty Report”) covering sales of Licensed Product for each
Miikana fiscal quarter (currently ending on or about the last day of March, June, September, and
December) with the following information provided on a country-by-country basis for the Major
Market countries and for the rest of the world as a whole:

          (a) Net Sales showing all deductions starting with gross sales;

          (b) the royalties, payable in Dollars, which shall have accrued hereunder in respect to such
Net Sales;

          (c) withholding taxes, if any, required by law to be deducted in respect of such sates;

          (d) the exchange rates used in determining the amount of Dollars; and

          (e) the royalty rates applied to calculate royalties due hereunder.

     Royalty Reports shall be due for the entire Territory no later than     *     days after the
end of the fiscal quarter to which they pertain.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-9-

 

     5.2 Exchange Rate; Manner of Payment. All payments due under this Agreement shall be
made in Dollars via wire transfer of immediately available funds, or by such other commercially
reasonable means as may be designated by Roche. Royalty payments due on Net Sales in countries
in the Territory outside the US shall be made in Dollars, after being converted by Miikana using
the average rate of exchange for such currencies during the applicable calendar quarter, as
retrieved from     *     system for the applicable period. If by law, regulations or fiscal
policies, remittance of royalties in Dollars, or removal of currency from the country, is
prohibited or restricted, Miikana will notify Roche and payment of the royalty obligation shall be
made by deposit thereof in local currency to the credit of Roche in a recognized banking
institution in such country designated by Rode. If in any country or jurisdiction, the law,
regulations or fiscal policies prohibit both the transmittal and deposit of royalties on sales in
such country, royalty payments calculated as a percentage of Net Sales in that country shall be
suspended for as long as such prohibition is in effect and as soon as such prohibition ceases, all
royalties that Roche would have otherwise been entitled to shall be transmitted or deposited to the
extent allowable.

     5.3 Payment Due Dates. Royalties shown to have accrued by each Royalty Report
provided for under Article 5 of this Agreement shall be due and payable     *     after the end of
the fiscal quarter to which they pertain. Payment of royalties in whole or in part may be made in
advance of such due date. All royalty and other payments due to Roche hereunder, shall be made in
Dollars and delivered to the account specified below or to any other account specified by Roche:

     WIRE PAYMENT TO:

	 	 	 
	Account of.

	 	Hoffmann-La Roche Inc
	Account No.:

	 	    *    
	Bank Name:

	 	    *    
	 

	 	    *    
	ABA Routing No:

	 	    *    

     5.4 Right to Audit

          (a) Upon written request to Miikana and at least     *     prior notice from Roche, at Roche’s
expense and not more that     *     a calendar year, Roche’s independent certified public
accountants may perform, on the behalf of Roche, an audit in accordance with GAAP standards of such
of Miikana’ books and records during normal business hours as may be reasonably necessary to verify
the accuracy of the Royalty Reports furnished by Miikana and to confirm payments made hereunder
with respect to any quarterly period ending not more than     *     prior to the date of such
request. Audits may be performed no more than once for a given audit period.

          (b) Miikana shall keep, and shall cause its Affiliates, sublicensees, and Affiliates’
sublicensees to keep, complete and accurate records pertaining to the sale of Licensed Products and
the royalties and other amounts payable under this Agreement in sufficient detail to permit Roche
to confirm the accuracy of all payments due hereunder for no less than     *      

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-10-

 

after the time periods to which such records relate. Miikana shall include in each written
sublicense granted by it pursuant to this Agreement a provision requiring the sublicensee to keep
and maintain records of sales made pursuant to such sublicense and to grant access to such records
by Roche’s auditor subject to the same terms and conditions as stated in this Section 5.4. Such
records shall be sufficient for Roche to determine Net Sales on a country-by-country basis.

          (c) Upon the expiration of     *     following the end of any quarterly royalty payment
period, the calculation of royalties payable with respect to such quarter shall be binding and
conclusive upon Roche (except with respect to any audit then underway, and except for fraud or
intentional misrepresentation), and the Miikana Group shall be released from any liability or
accountability with respect to royalties for such fiscal year.

          (d) Any report prepared by the auditor, shall disclose only the conclusions of the auditor
regarding the audit and the amount of any underpayment or overpayment of royalties, if any, without
disclosure of or reference to supporting documentation. A copy of such report shall be sent or
otherwise provided to Miikana by the auditor at the same time it is sent or otherwise provided to
Roche.

          (e) If an auditor’s report shows any underpayment of royalties, Miikana shall remit, or shall
cause its Affiliates, sublicensees, or Affiliates’ sublicensees to remit, to Roche the amount of
such underpayment within     *     after Roche’s receipt of the auditor’s report. If the amount
of any underpayment of royalties is in excess of     *     of the total royalties due to Roche with
respect to the period covered by the Auditor’s report, then Miikana shall reimburse Roche for the
cost of the audit in which the underpayment was discovered, the underpayment, and interest on the
underpayment at the     *     rate plus     *     . Any overpayment of royalties shall be fully
creditable against future royalties payable in subsequent royalty periods.

     5.5 Confidentiality of Records. Roche agrees that all information subject to review
under this Article 5 or under any sublicense agreement (other than the reported results of such
review) is confidential and that Roche and the auditor shall retain all such information in
confidence, although this condition is not intended to restrict Roche from enforcing any term or
provision of this Agreement in arbitration or court.

     5.6 Recruiting of forecasted sales. Commencing after the First Commercial Sale, each
year in June, Miikana shall provide Roche with a good faith Net Sales forecast for the following
    *     . This annual forecast shall be for informational purposes only and shall not confer
any right or obligation on either Party with respect to projected sakes figures. The forecast
will consist of Miikana’s reasonable estimate of the quarterly Net Sales for the two remaining
quarters in the then current year and the four quarters in the following year.     *         *    .

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-11-

 

ARTICLE
6

RESEARCH, DEVELOPMENT AND MARKETING

     6.1 Development. Prior to the Effective Date, Roche has conducted research and
development of the Compound. Miikana has drafted a Development Plan to guide the further clinical
development of the Compound and have appended it at Appendix C. The Development Plan merely
serves as a guide and may undergo substantive changes as it is implemented.

     6.2 Liaison.

          (a) At the Effective Date of this Agreement, Roche shall assign a Global Alliance Director to
be the liaison with Miikana. The Global Alliance Director will be the Roche point person with
primary responsibility for communications and interactions with Miikana related to:

(i)     *    

(ii)     *    

(iii)     *    

(iv)     *    

(v)     *    

          (b) Similarly and for reasons including those set out in Section 6.2(a). Miikana shall
assign a liaison with Roche.

     6.3 Development Program.

          (a) Miikana shall, at its expense, conduct a clinical and commercial development program
relating to the use of a Licensed Product using commercially reasonable efforts (“Development
Program”) consistent with the Development Plan. Miikana shall provide
___    *    ___written reports to the Global Alliance Director on the progress of the
Development Program, and     *     shall provide to the Global Alliance Director a written status
report of all Development Program activities.

          (b) At a minimum, the Development Plan shall include a Phase-to-Phase progression of the
program that is results- and regulatory-based. Miikana shall conduct a Phase II clinical program
in accordance with the Development Plan. The clinical portion of the Development Plan shall be
designed to obtain sufficient data to support progressing to one or

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-12-

 

more pivotal clinical trials designed to obtain sufficient data to support Registration in at
least one indication in the Field.

          (c) Based on the Phase II clinical data and correspondence from Regulatory Agencies concerning
such Phase II data, Miikana shall,     *     after completion of all Phase II clinical trials,
either (i) commence one or more pivotal clinical trials designed to obtain sufficient data to
support Registration in at least one indication in the Field or (ii) notify Roche that it is
terminating the Agreement.

          (d) The Development Plan may be reasonably modified and updated at any time as is deemed
necessary at the discretion of Miikana.

          (e) Reversion to Roche. Notwithstanding anything in this Agreement to the contrary, if at
any time and for any reason, whether scientific, technical, medical, economic, commercial or
otherwise, Miikana shall determine that it is not reasonable to continue clinical trials or other
development of Licensed Products, it may deliver a written notice of such determination to Roche,
and its election to cease further development, in which event, Roche may terminate the Agreement
and all licenses granted herein pursuant to Section 12.3(b). Likewise, if Miikana determines not
to pursue the development or commercialization of a Licensed Product in any of the following
sub-territories: (i) the US, (ii) Japan, (iii) the European Union (in such case at least     *    
of the Major Markets in the European Union), then Miikana shall provide Roche with written notice
of its decision and shall terminate this Agreement with respect to such sub-territory, within
    *     following Roche’s receipt of such notice, in which event, Roche may terminate the
Agreement and all licenses granted herein solely for such sub-territory pursuant to Section
12.3(b).

ARTICLE
7

PATENT RIGHTS 

     7.1 Patent Prosecution and Maintenance.

          (a) Roche shall, at its sole expense, prosecute any and all patent applications within the
Roche Patent Rights to obtain patents thereon and to maintain all patents included in the Roche
Patent Rights. Interferences, nullification proceedings and oppositions shall be considered a
part of the prosecution and maintenance of the Roche Patent Rights.

          (b) Miikana shall, at its sole expense, prosecute any and all patent applications within the
Miikana Patent Rights, to obtain patents thereon and to maintain all patents included in the
Miikana Patent Rights using patent counsel of its choice. Interferences, nullification
proceedings and oppositions shall be considered a part of the prosecution and maintenance of the
Miikana Patent Rights.

          (c) Miikana and Roche shall each keep the other reasonably informed of its prosecution of the
Miikana Patent Rights or Roche Patent Rights, as the case may be. Each Party agrees to provide
the other Party with a written report no less frequently than once each year updating
the other Party with respect to the status of its prosecution of the Miikana Patent Rights or Roche
Patent Rights. If either Party fails to perform its obligations under Section

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-13-

 

7.9(a) or (b), then the other shall have the right to perform such activities on its behalf.
At the request of the other Party at anytime during the term of this Agreement each Party shall
execute such documents as the other Party may deem necessary or advisable to protect or perfect its
rights in the relevant Patent Rights, and shall assist the other party in obtaining, defending and
enforcing such Party’s rights therein. Each Party hereby appoints the other as its
attorney-in-fact to execute on its behalf any documents deemed necessary or advisable by the other
Party to protect or perfect its rights to any relevant Patent Rights.

     7.2 Discontinuance/Abandonment. Notwithstanding won 7.1, each of Roche and Miikana
shall have the right to discontinue the prosecution of any patent application, or to abandon any
patent, encompassed within the Roche Patent Rights or Miikana Patents, as the case may be. If a
party (“Abandoning Party”) decides to abandon or allow to lapse any patent application or
patent within its patent rights (Roche Patent Rights or Miikana Patent Rights, as the case may be),
then the Abandoning Party shall inform the other party (“Non-Abandoning Party”) at least     *    
prior to such abandonment or lapse and the Non-Abandoning Party shall be given the opportunity to
have such patent assigned to it from the Abandoning Party. If a Roche patent application or
patent is assigned to Miikana, then for so long as such patent application or patent remains in
effect it shall be considered Roche Patent Rights for purposes of royalty payments under Article 4;
provided, however, Miikana shall be entitled to credit     *     of its costs actually incurred in
prosecuting and maintaining such patents against any future payments under Article 4, subject to
audit by Roche under Section 5.4.

     7.3 Status of Patent Rights. Within     *     after each anniversary of the
Effective Date, each of Roche and Miikana shall advise the other Party as to the then-current
status of any patent applications or patents within the advising Party’s Patent Rights
specifically relevant to any Licensed Product.

     7.4 Ownership of Future Inventions and Know-How.

          (a) Miikana shall disclose to Roche any Inventions related to the Compound, Derivatives,
Licensed Products, or any data generated through their use with respect to which it intends to file
a patent application. Disclosure pursuant to this Section 7.4(a) shall be made not later than one
month prior to filing a patent application with respect to such items.

          (b) Patentable and unpatentable Inventions or Know-How made, developed or conceived by Miikana
personnel alone (or jointly with one another) shall be the sole property of Miikana (“Miikana
Inventions”). Miikana shall have sole discretion and responsibility to prepare file,
prosecute and maintain patent applications for Miikana Inventions, and shall be responsible for
related interference proceedings.

          (c) Patentable and unpatentable Inventions or Know-How made, developed or conceived by Roche
personnel alone (or jointly with one another) shall be the sole property of Roche (“Roche
Inventions”). Roche shall have sole discretion and responsibility to prepare file, prosecute
and maintain patent applications for Roche Inventions, and shall be responsible for related
interference proceedings.

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-14-

 

          (d) Patentable or unpatentable Inventions or Know-How jointly made, developed or conceived by
Miikana and Roche personnel shall be jointly owned, unless the Parties agree otherwise. Patent
applications for joint inventions shall be prepared and prosecuted jointly.

          (e) In no event shall any disclosure of compounds, inventions or other information in
accordance with this Section 7.4 be construed as an offer to sell those compounds, inventions or
other information. Any disclosure under this Section 7.4 shall be subject to the confidentiality
provisions of this Agreement.

ARTICLE
8

INFRINGEMENT

     8.1 Applicability. The provisions of this Article 8 shall govern the Parties’ rights
and obligations, as between themselves, with respect to actions against Third Parties for
infringement of the patents or misappropriation of the Know-How licensed under this Agreement.
Notwithstanding the foregoing, in the case of patents and Know-How licensed under this Agreement
that is owned by a Third Party, then the Parties’ rights to enforce such patents or any right in
such Know-How shall be subject to the rights of such Third Party set forth in its agreement with
the Party that Controls such patents or Know-How.

     8.2 Third Party Infringement.

          (a) If either Miikana or Roche becomes aware of any product made, used, sold or imported in
the Territory which it believes to (i) infringe a Valid Claim within the Roche Patent Rights
(“Field Infringement”) or the Miikana Patent Rights, (ii) or constitute a misappropriation
of Know-How owned or Controlled by either Party covering or relating to a Licensed Product or its
manufacture or use, then such Party (the “Notifying Party”) shall promptly (     *     in
the event of receiving a Paragraph IV Certification described in 21 C.F.R. § 314.50(i)(A)(4))
advise the other Party of all the relevant facts and circumstances known by the Notifying Party in
connection with the infringement or misappropriation.

          (b) The Parties agree that Roche shall have the right, at its own expense, but not the
obligation, to enforce Roche Patent Rights against Field Infringement and Miikana shall have the
right, at its own expense, but not the obligation, to enforce Miikana Patent Rights against
infringement. Miikana and its Affiliates shall fully cooperate with Roche with respect to the
investigation and prosecution of such alleged Field Infringement or misappropriation including
(without limitation) the joining of Miikana and its Affiliates as a party to such action, as may be
required by the law of the particular forum where enforcement is being sought. Roche and its
Affiliates shall fully cooperate with Miikana with respect to the investigation and prosecution of
such alleged infringement of the Miikana Patent Rights or misappropriation including (without
limitation) the joining of Roche and its Affiliates as a party to such action, as may be required
by the law of the particular forum where enforcement is being sought.

          (c) If Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), then
Miikana shall have the right to intervene and pursue its own damages claim

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-15-

 

against any alleged Field Infringement if such Field Infringement is caused by the
manufacture, use or sale of a product containing a Compound or Derivative. Any such intervention
by Miikana under this Section 8.2(c) shall be controlled by Miikana with respect to such damages
claim; however, Roche shall remain in control of the defense against any claim, counterclaim or
defense of patent invalidity or unenforceability related to any such Field Infringement.

          (d) Roche grants to Miikana the right to enforce the Roche Patent Rights against Field
Infringement, if:

               (i) Roche fails, within     *     (     *     in the event of the filing of a Paragraph IV
Certification) after receiving notice from Miikana of the Field Infringement to (1) notify Miikana
that Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), (2) take
reasonable action to investigate such alleged infringement, and (3) promptly thereafter, institute
an action to abate such alleged infringement and to prosecute such action diligently (i.e. within
    *     or     *     in the event of the filing of a Paragraph IV Certification), or

               (ii) Roche earlier notifies Miikana that Roche does not plan to terminate the infringement or
institute such action solely pursuant to Section 8.2(b).

Roche and its Affiliates shall fully cooperate with Miikana, at Miikana’s expense, with respect to
the investigation and prosecution of such alleged infringement including (but not limited to) the
joining of Roche and its Affiliates as a party to such action, as may be required by the law of the
particular forum where enforcement is being sought. Any such enforcement action by Miikana under
Roche Patent Rights shall be limited to enforcement against Field Infringement caused by the
manufacture, use or sale of a product containing a Compound or Derivative, and shall not without
the advance written consent of Roche extend to any other infringement.

          (e) If Roche is prosecuting an infringement action under Section 8.2(b), then Roche shall have
the right to control such litigation and shall bear all legal expenses (including court costs and
legal fees and expenses), including settlement thereof. If a claim for damages is brought by
Miikana pursuant to Section 8.2(c), then Miikana shall have such right to control such claim for
damages and shall bear all its legal expenses (except as provided otherwise in the event that Roche
should join as a party to such action). No settlement or consent judgment or other voluntary
final disposition of any infringement action brought by a Party pursuant to this Section 8.2 may be
entered into without the prior written consent of the other Party if such settlement would require
the other Party to be subject to an injunction or to make a monetary payment or would restrict the
claims in or admit any invalidity of any of the Roche Patent Rights or Miikana Patent Rights or
significantly adversely affect the rights of the other Party to this Agreement.

Roche shall be entitled to keep, out of all damages or costs recovered by Roche in connection with
any action filed by Roche under Section 8.2(b), and after first reimbursing both parties for any
out-of-pocket costs and expenses incurred in bringing the action (“Roche Net Recovery”), an amount
equal to: (i)     *     of such Roche Net Recovery for actions against a Field Infringement that do
not involve manufacture, use or sate of a product containing a Compound or Derivative, and (ii)
    *     of the Roche Net Recovery from any action to the extent

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-16-

 

involving manufacture, use or sale of a product containing a Compound or Derivative, and the rest
of such Roche Net Recovery shall be provided to Miikana. Miikana shall be entitled to keep
    *     of all damages or costs recovered by Miikana in connection with any claim for damages
brought by Miikana under Section 8.2(c) or 8.2(d), after first reimbursing both parties for any
out-of-pocket costs and expenses incurred in bringing the action (“Miikana Net Recovery”), and the
rest of such Miikana Net Recovery     *     shall be provided to Roche. If the Parties jointly
prosecute such infringement action and jointly share expenses, then the Parties will split
    *     all damages or costs recovered, after first reimbursing each Party pari passu for any
out-of-pocket expenses in such action. If the recovery of a Party prosecuting an action solely
under this Section 8.2 does not exceed the Parties’ costs in such action, then each Party shall be
reimbursed pari passu for any out-of-pocket expenses incurred in such action.

          (f) Sections 8.2(b)-(e) shall apply mutatis mutandis to trade secret misappropriation actions
relating to activities as it does to enforcement of Valid Claims against Field Infringement.

          (g) Neither Party shall be entitled to grant covenants not to sue or other similar rights
under patents owned or controlled by the other Party, provided, however, Miikana
may grant licenses and sublicenses in accordance with Section 2.2.

ARTICLE
9

REPRESENTATIONS AND WARRANTIES

     9.1 Representations and Warranties of Roche. Roche hereby represents and warrants to
Miikana as of the Effective Date that:

          (a) Roche Nutley and Roche Basel are duty incorporated, validly existing and in good standing,
with the corporate power and authority to enter into this Agreement and to perform their
obligations hereunder. The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby have been duly authorized by all requisite corporate action on the
part of Roche. This Agreement has been duly executed and delivered by Roche and constitutes the
valid, binding and enforceable obligation of Roche, subject to applicable bankruptcy,
reorganization, insolvency, moratorium and other laws affecting creditors’ fights generally from
time to time in effect and to general principles of equity.

          (b) Roche is not subject to, or bound by, any provision of

               (i) any articles or certificates of incorporation or by-laws;

               (ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction; or

               (iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator;

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-17-

 

that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by Roche of
this Agreement and the obligations contained herein, including without limitation, the grant to
Miikana of the license described in Section 2.1 hereof.

          (c) ___    *     under the Roche Patent Rights for purposes other than the manufacture,
use, offer for sale, importation or sale of a Compound or Derivative, or any product containing a
Compound or Derivative; (ii) with the exception of license rights that may have been or may be
granted under the Roche Patent Rights for purposes other than the manufacture, use, offer for sale,
importation or sale of a Compound or Derivative, or any product containing a Compound or Derivative
    *     ; and (iii) other than facts made available to Miikana during due diligence and facts
contained in patent oppositions and other publicly available records (such as prosecution histories
and the like), there     *     .

     9.2 Representations and Warranties of Miikana. Miikana hereby represents and
warrants to Roche as of the Effective Date that:

          (a) Miikana is a corporation duly incorporated, validly existing and in good standing under
the laws of the jurisdiction of its organization, with the corporate power and authority to enter
into this Agreement and to perform its obligations hereunder. The execution and delivery of this
Agreement and the consummation of the transactions contemplated hereby have been duly authorized by
all requisite corporate action on the part of Miikana. This Agreement has been duly executed and
delivered by Miikana and constitutes the valid, binding and enforceable obligation of Miikana,
subject to applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting
creditors’ rights generally from time to time in effect and to general principles of equity.

          (b) Miikana is not subject to, or bound by, any provision of:

               (i) any articles or certificates of incorporation or by-laws;

               (ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction, or

               (iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator,

that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by Miikana
of this Agreement and the obligations contained herein.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-18-

 

     9.3 Disclaimer of Warranties. EXCEPT AS SET FORTH EXPRESSLY IN THIS AGREEMENT, EACH
PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL RIGHTS OF THIRD PARTIES. WITHOUT LIMITING THE
GENERALITY OF THE FOREGOING, BOTH PARTIES ACKNOWLEDGE AND DISCLAIM ANY WARRANTY AS TO: (1) THE
SUCCESS OF ANY DEVELOPMENT OR CLINICAL TRIAL, STUDY OR TEST COMMENCED BY UNDER THIS AGREEMENT; OR
(11) REGULATORY APPROVAL, PRODUCT INTRODUCTION, SAFETY, USEFULNESS OR COMMERCIAL SUCCESS OF ANY
LICENSED PRODUCT.

ARTICLE
10

CONFIDENTIALITY

     10.1 Treatment of Confidential Information. Except as otherwise provided in this
Article 10, during the term of this Agreement and for a period of     *     thereafter, Miikana and
its Affiliates will retain in confidence and use only for purposes of this Agreement any
information, data, and materials supplied by Roche or on behalf of Roche to Miikana and its
Affiliates under this Agreement, and Roche will retain in confidence and use only for purposes of
this Agreement any information, data, and materials supplied by Miikana or on behalf of Miikana to
Roche under this Agreement. For purposes of this Agreement, all such information and data which a
Party is obligated to retain in confidence shall be called “Confidential Information” of the
disclosing Party.

     10.2 Right to Disclose. To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement or any rights which survive
termination or expiration hereof, Miikana and Roche each may disclose the Confidential Information
of the other Party to their respective Affiliates, sublicensees, consultants, outside contractors,
clinical investigators or other Third Parties provided that such entities or persons agree in
writing (a) to keep the Confidential Information confidential for the same time periods and to the
same extent as Miikana and Roche are required to keep the Confidential Information confidential and
(b) to use the Confidential Information only for such purposes as Miikana and Roche (as applicable)
are entitled to use the Confidential Information. Each Party or its Affiliates or sublicensees
may disclose such Confidential Information of the other Party to government or other regulatory
authorities to the extent that such disclosure (i) is reasonably necessary to obtain patents or
authorizations to conduct clinical trials with or to market commercially the Licensed Products,
provided such Party is otherwise entitled to engage in such activities under this Agreement; (ii)
is otherwise legally required; (iii) is in facilitation of a Party’s relationship with its existing
or prospective investors; or (iv) is permitted pursuant to Section 14.7; provided that if a Party
is legally required to make such a disclosure under (ii), it shall first have given prompt notice
to the other Party hereto to enable it to seek any available exemptions from or limitations on such
a disclosure, or to apply for confidential treatment or a protective order.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-19-

 

     10.3 Release From Restrictions. The foregoing obligations in respect of disclosure
and use of Confidential Information shall not apply to any part of such Confidential Information
that the receiving Party, or its Affiliates (all collectively referred to as the “Receiving Party”)
can demonstrate by competent evidence:

          (a) is or becomes publicly available other than by acts of the Receiving Party in breach of
this Agreement;

          (b) is disclosed to the Receiving Party or its Affiliates or-sublicensees by a Third Party who
had the right to disclose such Confidential Information to the Receiving Party;

          (c) prior to disclosure under this Agreement, was already in the possession of the Receiving
Party or its Affiliates or-sublicensees, provided such Confidential Information was not obtained,
directly or indirectly, from the other Party under this Agreement; or

          (d) was independently discovered or developed by the Receiving Party without resort to or use
of any Confidential Information of the disclosing Party.

     10.4 Confidentiality of Agreement. Except as otherwise required by law or the terms
of this Agreement or mutually agreed upon by the Parties hereto, each Party shall treat as
confidential the terms; and conditions of this Agreement, except that Roche and Miikana may each
disclose such terms and conditions and the achievement of milestone and other significant events
under this Agreement to its Affiliates and sublicensees, and to current and potential investors,
merger partners or acquirors. Furthermore, either Party in connection with its current or future
status as a public company may disclose the terms of this Agreement to the extent required by the
federal securities laws, and provided, that the disclosing Party shall seek confidential treatment
of key business terms contained in this Agreement, including but not limited to the royalty rates,
the research and development reimbursement and the milestone payments; provided, however, that the
disclosing Party shall duly consider reasonable and timely suggestions, advice and input from the
non-disclosing Party with respect to seeking confidential treatment of key business terms contained
in the Agreement. After execution of this Agreement, the Parties shall release the joint press
release, the text of such shall be mutually agreeable to each Party, announcing the execution of
the Agreement. In addition, the Parties have agreed to the publicity-related provisions that are
set forth in Section 14.7.

     10.5 Return of Confidential Information. Upon termination of this Agreement by
either Party for any reason, the rights of each Party to retain and use the Confidential
Information of the other shall be as provided in Article 12, provided, however, that each Party may
retain a single archival copy of the other Party’s Confidential Information solely for the purpose
of determining the extent of disclosure of Confidential Information hereunder and assuring
compliance with the surviving provisions of this Agreement.

ARTICLE
11

TRANSFERS AND ACCESS- REGULATORY

     11.1 Transfer of Know-How. Within     *     after the Effective Date, Roche shall
transfer to Miikana all of the Transfer Know-How to the extent available.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-20-

 

Within
    *     after the Effective Date, Roche shall transfer to Miikana the remainder of the Transfer
Know-How. Roche agrees to provide to Miikana upon Miikana’s reasonable request and at Miikana’s
sole expense the prosecution files and histories of the Roche Patent Rights that are not publicly
available.

     11.2 Support. During the period beginning     *     thereafter, Roche shall allow
Miikana to have     *     with available Roche key personnel at Roche’s facilities to answer
questions pertaining to the Roche Know-How. During this     *     , Roche shall provide Miikana
with reasonable access to key employees, if any, who are available at the time of request. All
such requests by Miikana shall be made to the Roche employee designated to coordinate such
requests. Such access shall not exceed     *    , of which no more than     *     shall be from any one of
the following groups:     *     .

     11.3 Regulatory Affairs.

          (a) During the Term, Miikana shall (i) control and be solely responsible for making all needed
Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining
Registrations of Licensed Products in the Field throughout the Territory, in such countries as it
selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings,
including preparing all applications and reports necessary as part of an IND, NDA, DMF, BLA or
other necessary filing required for Registration. Roche shall assign to Miikana all rights, title
and interest in and to all Regulatory Filings that Roche has made with respect to any Compound or
Derivative and all licenses, authorizations and permits that Roche has obtained with respect to
clinical trials of any Compound or Derivative. Roche shall permit Miikana to access, and shall
provide Miikana with sufficient rights to reference and use in association with exercising its
rights and performing its obligations under this Agreement, all records pertaining to Compounds,
Derivatives or Licensed Products as are in the possession and Control of Roche and are reasonably
necessary for obtaining Registrations for Licensed Products.

          (b) In conducting any research or development activities under this Agreement, Miikana shall
(i) ensure that its employees, agents, clinical institutions and clinical investigators comply with
all FDA statutory and regulatory requirements with respect to Licensed Products, including but not
limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health Service Act,
Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by a reviewing
IRB or the FDA; and (ii) not utilize, in conducting studies on Licensed Products, any person or
entities that at such time are debarred by the FDA, or that, at such time, are under investigation
by the FDA for debarment action pursuant to the provisions of 21 U.S.C. § 335.

     11.4 Meetings with Regulatory Authorities. Miikana shall inform Roche of any meeting
between Miikana and any Regulatory Authority to the extent that such meeting relates to the
development of the Licensed Product. Roche shall be entitled, at its own expense, to have a Roche
representative attend any such meeting.

     11.5 Supply of Active Compound. Miikana shall purchase from Roche at least
___    *    ___of
    *    
Compound (“ * ”) for     *    

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-21-

 

    *     payable within     *     days after the Effective Date. Roche shall deliver such
MBP to Miikana within     *     days after receiving Miikana’s payment. Roche shall retain in
storage     *     of MBP for a period of     *     beginning on the Effective Date. If Miikana
wants Roche to store MBP beyond the     *     of the Effective Date, then Miikana shall pay to
Roche     *     and Roche shall store such MBP until the second anniversary of the Effective Date.
If Miikana wants to purchase the entire     *     of MBP at any time during the time in which such
MBP is stored by Roche, then Miikana may do so by paying Roche     *     and Roche shall deliver
such MBP to Miikana within     *     days after receiving Miikana’s payment. MBP supplied to
Miikana under this Section 11.5 shall comply with the specifications set forth in Appendix D.
Transfer shall be     *     at a location identified by Roche. If the MBP fails to comply with
the specifications set forth in Appendix D, then Miikana shall dispose of the
non-complying-MBP at its own cost and Roche shall reimburse Miikana for the payment made
for such MBP.

     11.6 Product Recalls. Each Party shall advise the other if it determines that an
event, incident, or circumstance has occurred which may result in the need for a recall or other
removal of any Licensed Product, or a lot or lots thereof, from the market.

ARTICLE
12

TERM AND TERMINATION

     12.1 Term. This Agreement shall become binding upon the Effective Date. This
Agreement shall continue thereafter in full force and effect, unless terminated sooner pursuant to
Sections 12.2 or 12.3 below, until it expires upon the expiration of both Parties’ obligation to
pay royalties to the other hereunder (such expiration of the term of this Agreement without
termination, “Expiration”).

     12.2 Miikana Right to Terminate.

          (a) For Material Breach at any Time. Miikana may terminate this Agreement, as a
whole, at any time if (i) Roche materially breaches the Agreement and (ii) such material breach is
not cured by Roche within     *     after Miikana provides Roche with written notice of such
breach, or, if such breach cannot be cured through commercially reasonable efforts within such
    *     , and Roche has (within such time period) submitted a plan for cure as promptly as is
reasonably practicable through the application of commercially reasonable efforts with a cure date
reasonably acceptable to Miikana, after the earlier of the cure date agreed to by Miikana or the
date Roche ceases commercially reasonable efforts to cure such breach.

          (b) For Convenience. Miikana may terminate this Agreement for convenience, upon
    *     days prior written notice to Roche, provided that such notice of termination may not
occur until     *     . Miikana may commence to wind down all of its activities under this
Agreement immediately upon such notice. Mikana may terminate this Agreement pursuant to this
Section 12.2(b) either in its entirety or in any or the following areas: (1) the US as a whole; (2)
the European Union and

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

-22-

 

the territories and possessions of its member countries as a whole; (3) Japan and its
territories and possessions as a whole; and (4) for countries not encompassed within (1), (2) and
(3), in individual countries (and their territories and possessions) on a country-by-country basis.

          (c) EU Termination. As regards termination for convenience in the European Union
pursuant to this Section 12.20, such termination shall be initially effective as of the expiration
of the     *     notice period in each country that is at that time a member of the European Union
(together with their territories and possessions), and within each country (together with its
territories and possessions) that subsequently becomes a member of the European Union,     *    
after it becomes such a member.

     12.3 Roche’s Right to Terminate.

          (a) For Material Breach at any Time. Roche may terminate this Agreement, as a whole,
at any time if (i) Miikana materially breaches the Agreement and (ii) such material breach is not
cured by Miikana within     *     after Roche provides Miikana with written notice of such breach,
or, if such breach cannot be cured through commercially reasonable efforts within such     *     ,
and Miikana has (within such time period) submitted a plan for cure as promptly as is reasonably
practicable through the application of commercially reasonable efforts with a cure date reasonably
acceptable to Roche, after the earlier of the cure date agreed to by Roche or the date Miikana
ceases commercially reasonable efforts to cure such breach. If Miikana files a petition for
bankruptcy, dissolution, liquidation or winding up of affairs, then such petition shall not relieve
Miikana of its obligation for continued performance under this Agreement pending a decision on such
petition.

          (b) For Miikana’s Discontinuance of the Development Plan. Notwithstanding anything
in this Agreement to the contrary, Roche may terminate the Agreement and all licenses granted
herein following receipt of written notice from Miikana of Miikana’s decision to discontinue all of
Miikana’s activities under the Development Plan pursuant to Section 6.3(c) in either the Territory
or a sub-territory (as defined in Section 6.3(e)), as applicable. Following such termination and
at Roche’s request, Miikana shall negotiate in good faith with Roche to license on commercially
reasonable terms to Roche the Miikana Patent Rights and Miikana Know-How related solely to the
Licensed Products.

     12.4 General Effect of Expiration or Termination. Upon Expiration or termination of
this Agreement for any reason, all rights and obligations of the Parties hereunder shall cease,
except as explicitly provided for below in this Article 12 or elsewhere in this Agreement.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation to make
payments or otherwise to the extent related to events or other facts in existence prior to such
Expiration or termination.

     12.5 Rights Upon Expiration or Any Termination.

          (a) Upon Expiration of this Agreement in any country, Miikana shall continue to have a
royalty-free, perpetual right to Commercialize Licensed Products in the Territory, as the license
granted Miikana in Section 2.1 shall automatically become royalty-free, non-exclusive and perpetual
in the country of Expiration.

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-23-

 

          (b) Upon Expiration or termination of this Agreement for any reason, the following Sections
and Articles shall survive such expiration or termination, subject to any later termination dates
provided for therein: Sections 5.1 and 5.2 (with respect to payments having accrued during the term
of this Agreement); Sections 5.4; 5.5; and 9.3, and Articles 1, 8 (as relates to infringement
occurring during the term of this Agreement), 10, 12, 13 and 14.

     12.6 Rights Upon Certain Miikana Terminations.

          (a) Upon termination by Miikana for Roche’s uncured material breach of this Agreement pursuant
to Section 12.2(a), the following Sections shall survive such termination in addition to the
Sections and Articles set forth to survive in Section 12.5(b): Sections 2.1; and 3.1, 3.2 and 3.3
(with continued milestone payments); Article 4 (with continued royalty payments) and all other
Sections and Articles governing the mechanics of milestone and royalty payments hereunder. The
licenses granted by Roche to Miikana shall become     *     if Miikana terminates under Section
12.2(a).

          (b) If Miikana terminates this Agreement for any reason, other than Roche’s uncured material
breach of this Agreement pursuant to Section 12.2(a), then Miikana’s obligations pursuant to
Section 3.1 shall survive such termination.

     12.7 Rights Upon Roche Termination for Cause and Other Miikana Terminations. If
Roche terminates this Agreement pursuant to Section 12.3, or Miikana terminates this Agreement for
convenience pursuant to Sections 12.2(b), 12.2(c) or 12.2(4), then:

          (a) Reverted Territory: Reverted Products. The Territory, in the case of a
termination in whole, and the terminated country or countries (together with their territories and
possessions) in the case of a partial termination, shall be deemed to be the “Reverted Territory”
effective as of the effective date of such termination. In the case of a partial termination, the
Reverted Territory shall thereafter be excluded from the Territory for all purposes under this
Agreement, but this Agreement will remain in effect in the remaining Territory. All Licensed
Products in the Reverted Territory shall, effective upon the effective date of such termination, be
deemed “Reverted Products.”

          (b) No Further Representations. The Miikana Group shall discontinue making any
representation regarding its status as a licensee of or distributor for Roche in the Reverted
Territory, for all Reverted Products. The Miikana Group shall cease conducting any activities with
respect to the marketing, promotion, sale or distribution of the Reverted Products in the Reverted
Territory.

          (c) Technology License. Miikana hereby grants to Roche, effective upon such
termination, the right to negotiate a license on commercially reasonable terms under (i) any patent
or patent application owned by Miikana (or any Miikana Affiliate) covering the Reverted Products
having been developed or commercialized by the Miikana Group during the term of this Agreement, and
(ii) all Know-How owned or Controlled by Miikana and its Affiliates relevant to Reverted Products,
solely for Roche to Commercialize Reverted Products in the Reverted Territory, and to manufacture
Reverted Products anywhere in the world for such Commercialization, and (iii) any Regulatory
Filings of Miikana in the Reverted Territory.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-24-

 

          (d) Remaining Quantities. At Roche’s request, Miikana shall sell to Roche
___    *    ___quantities of Compound or Derivative related to Reverted Products in
the possession of the Miikana Group, in the case of a Territory-wide termination, or in their
possession and labeled for sale in any country of the Reverted Territory, in the case of a partial
termination, subject to all the disclaimers in Section 9.3. Such sale shall be     *     at a
location identified by Miikana.

          (e) No Further Sales. Miikana covenants that promptly upon such termination it and
its Affiliates and former sublicensees hereunder shall cease to sell, and thereafter shall not
sell, any Reverted Product in the Reverted Territory prior to     *     after the effective date of
termination.

          (f) Cross-Border Sales After Partial Termination. To the extent permitted by law,
Miikana shall take reasonable measures to prevent any sales of Licensed Product originally sold by
it in the Territory into the Reverted Territory. Such measures shall include without limitation,
to the extent permitted by law: (i) refraining from selling quantities of Licensed Products to any
entity Miikana has reason to believe (including as a result of written notice from Roche) may cause
such quantities to be resold in the Reverted Territory, and (ii) contractually requiring each of
its sublicensees and distributors of Licensed Produces to refrain from selling quantities of
Licensed Products to any entity that the sublicensee or distributor has reason to believe may cause
such quantities to be resold in the Reverted Territory. If Roche believes that Licensed Product
originally sold by Miikana in the Territory is being sold in the Reverted Territory, senior
executives of the Parties shall meet to discuss the situation. If such resale is occurring, then
the Parties shall mutually agree on an equitable mechanism to compensate Roche for lost sales of
Reverted Products in the Reverted Territory. In addition, this Section 12.7(f) shall apply to
Roche mutatis mutandis to require that Roche must guard against Reverted Product originally sold in
the Reverted Territory being resold into the Territory.

ARTICLE
13

INDEMNIFICATION

     13.1 Indemnification by Miikana. Subject to Sections 13.3 and 14.14 hereof, Miikana
hereby agrees to defend, indemnify and hold harmless Roche and its Affiliates and licensors, and
their directors, officers, employees and agents (“Roche Indemnitees”) from and against any
liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and
expenses and expenses incurred in connection with the enforcement of this provision), resulting
from any Third Party suits, actions, or claims brought or threatened after the Effective Date of
this Agreement and which arise out of claims against Roche brought by Third Parties after the
Effective Date of this Agreement, including but not limited to, any actions in contract (including
breach of warranty) tort (including negligence, strict liability or commercial torts) which arise,
result from, or relate to:

               (i) any breach of any of the representations or warranties of Miikana contained in
Section 9.2 hereof,

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-25-

 

               (ii) the gross negligence, recklessness or willful misconduct of the Miikana and its
Affiliates; and

               (iii) any development or Commercialization (including without limitation; any
manufacture, storage, use or possession) of Compound, Derivative or Licensed Product by
Miikana, its Affiliates, sublicensees and distributors.

Items (i) through (iv) are hereinafter collectively referred to as a “Roche Loss.” Miikana shall
have no obligation to indemnify Roche, to the extent that any Roche Loss arises out of the gross
negligence or willful misconduct of any Roche Indemnitee or Roche’s breach of this Agreement.

     13.2 Indemnification by Roche. Subject to Sections 13.3 and 14.14 hereof, Roche
hereby agrees to indemnify and hold harmless Miikana and its Affiliates and, sublicensees, and
their directors, officers, employees and agents (Miikana Indemnitees”) from and against any
liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and
expenses and expenses incurred in connection with the enforcement of this provision), resulting
from any Third Party suits, actions, or claims brought or threatened after the Effective Date of
this Agreement and which arise out of claims against Miikana brought by Third Parties after the
Effective Date of this Agreement, including but not limited to, any actions in contract (including
breach of warranty), tort (including negligence, strict liability or commercial torts) which arise,
result from, or relate to:

               (i) any breach of any of the representations or warranties of Roche contained in Section 9.1
hereof, and

               (ii) the gross negligence, recklessness or willful misconduct of Roche, its Affiliates or
agents.

Items (i) through (ii) are hereinafter collectively referred to as an “Mikkana Loss.” Roche shall
have no obligation to indemnify Miikana, to the extent that any Miikana loss arises out of the
gross negligence or willful misconduct of any Miikana Indemnitee or Miikana breach of this
Agreement.

     13.3 Indemnification Procedures With Respect to Third Party Claims.

          (a) To be eligible to seek indemnification under this Article 13 in respect to a liability,
loss, fine, penalty, damage, expense, action, or claim brought against such Indemnitee by a Third
Party (such claim hereinafter referred to as a “Third Party Claim”), a Miikana Indemnitee or Roche
Indemnitee (each, an “Indemnitee”) shall promptly give written notice thereof to the Party from
whom indemnification is sought (such Party hereinafter referred to as the “Indemnitor”) within a
reasonable period of time after the assertion of such Third Party Claim by such Third Party;
provided, however, that the failure to provide written notice of such Third Party Claim within a
reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder,
except to the extent that the Indemnitor is prejudiced by such failure. The Indemnitor shall have
the right to assume the complete control of the defense, compromise or settlement of any Third
Party Claim (provided that no settlement of any Third Party Claim shall include any admission of
wrongdoing on the part of an Indemnitee, without the prior written consent of such Indemnitee,
which consent shall not be unreasonably withheld),

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-26-

 

including, at its own expense, employment of legal counsel. At any time thereafter the
Indemnitor shall be entitled to exercise, on behalf of the Indemnitee, any rights which may
mitigate the extent or amount of such Third Party Claim; provided, however, that if the Indemnitor
shall have exercised its right to assume control of such Third Party Claim, the Indemnitee (i) may,
in its sole discretion and at its own expense (which expense shall not be subject to
indemnification hereunder), employ legal counsel to represent it (in addition to the legal counsel
employed by the Indemnitor) in any such matter, and in such event legal counsel selected by the
Indemnitee shall be required to confer and cooperate with such counsel of the Indemnitor in such
defense, compromise or settlement for the purpose of informing and sharing information with the
Indemnitor; (ii) shall, at its own expense, make available to Indemnitor those employees, officers
and directors or Indemnitee whose assistance, testimony or presence is necessary or appropriate to
assist the Indemnitor in evaluating and in defending any such Third Party Claim (provided, however,
that any such access shall be conducted in such a manner as not to interfere unreasonably with the
operations of the businesses of Indemnitee); and (iii) shall otherwise fully cooperate with the
Indemnitor and its legal counsel in the investigation and defense of such Third Party Claim.

          (b) If the Parties acting in good faith cannot agree as to the applicability of Section 13.1
and/or 13.2 to a particular Third Party Claim, then each Party (and its respective Indemnitees)
reserves the right to conduct its own defense of such Third Party Claim and seek indemnification
from the applicable Party upon its resolution.

ARTICLE
14

GENERAL PROVISIONS

     14.1 Force Maieure. Neither Party shall be held liable or responsible to the other
Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement, other than an obligation to make payments
hereunder, when such failure or delay is caused by or results from fire; flood; earthquake;
tornado; embargo; government regulation; prohibition or intervention; war; act of war (whether war
be declared or not); insurrection; act of terrorism; riot; civil commotion; strike; lockout; act of
God or any other cause beyond the reasonable control of the affected Party to anticipate, prevent,
avoid or mitigate (a “Force Majeure Event”) so long as the affected Party uses commercially
reasonable efforts to overcome the effects of the Force Majeure Event; provided, however, that any
failure or delay in fulfilling a term of this Agreement shall not be considered a result of a Force
Majeure Event if it arises from a knowing=failure of Miikana or Roche to comply with
applicable laws and regulations.

     14.2 Further Assurances. Each Party hereto agrees to perform such acts, execute such
further instruments, documents or certificates, and provide such cooperation in proceedings and
actions as may be reasonably requested by the other Party in order to carry out the intent and
purpose of this Agreement, including without limitation the registration or recordation of the
rights granted hereunder.

     14.3 Severabilitv. Both Parties hereby expressly acknowledge and agree that it is
the intention of neither Party to violate any public policy, statutory or common law, rules,

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-27-

 

regulations, treaty or decision of any government agency or executive body thereof of any
country or community or association of countries and specifically agree that if any word, sentence,
paragraph, clause or combination thereof in this Agreement is found by a court or executive body
with judicial powers having jurisdiction over this Agreement or any of the Parties hereto in a
final unappealed order, to be in violation of any such provisions in any country or community or
association of countries, then in such event such words, sentences, paragraphs, clauses or
combination shall be inoperative in such country or community or association of countries (or
reformed, for example but without limitation, to apply for a shorter period of time, such that
their effect is in compliance with law) and the remainder of this Agreement shall remain binding
upon the Parties hereto.

     14.4 Notices. Any notice required or permitted to be given hereunder shall be in
writing and shall be deemed to have been properly given if delivered in person, or if mailed by
registered or certified mail (return receipt requested) postage prepaid, or by a nationally
recognized overnight courier, or by facsimile (and promptly confirmed by registered, certified
mail, overnight courier or fax receipt), to the addresses given below or such other addresses as
may be designated in writing by the Parties from time to time during the term of this Agreement.
Any notice sent by overnight courier or facsimile shall be deemed received on the first business
day after posted with the courier or transmittal. Any notice sent by registered, certified mail
shall be deemed received on     *     business day following the date of posting.

In the case of Miikana:

Miikana Therapeutics

6519 Dumbarton Circle

Fremont, CA 94555

Attention: President

Telephone No.: (510) 818-2750

Facsimile No.: (510) 818-9955

and:

Cooley Godward LLP

Five Palo Alto Square

3000 El Camino Real

Palo Alto, CA 94306

Attention: Barclay James Kamb, Esq.

Telephone No.: (650) 843-5052

Facsimile No.: (650) 849-7400

In the case of Roche:

Hoffmann-La Roche Inc.

340 Kingsland Street

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

Nutley, NJ 07110

Attention: Corporate Secretary

-28-

 

and:

F. Hoffmann-La Roche Ltd

Grenzacherstrasse 124

CH-4070 Basel

Switzerland

Attention: Corporate Law

     14.5 Assignment. All of the terms and provisions of this Agreement shall be binding
upon and inure to the benefit of and be enforceable by the respective successors and permitted
assigns of the Parties hereto, but neither this Agreement nor any of the rights, interests or
obligations hereunder of any Party hereto shall be assigned without the prior written consent of
the other Party (which may be withheld for any reason), provided, however, that either Party may,
without such consent, assign this Agreement in whole or in part-(i) to a successor corporation in
connection with the transfer or sale of all or substantially all of its business to which this
Agreement pertains or in the event of the merger or consolidation with another corporation; and
(ii) to an Affiliate. Any purported assignment in violation of the preceding sentence shall be
void. Any permitted assignee shall assume all obligations of its assignor under this Agreement.

     14.6 Performance by Affiliates. Each of Roche and Miikana acknowledge that their
obligations and rights under this Agreement may be performed and exercised by Affiliates of Roche
and Miikana, respectively. Obligations of the Party for which one of its Affiliates is performing
hereunder shall be deemed to extend to such performing Affiliate. Each of Roche and Miikana
guarantee performance of this Agreement by its Affiliates. Wherever in this Agreement the Parties
delegate responsibility to Affiliates or local operating entities, the Parties agree that such
entities shall not make decisions inconsistent with this Agreement, amend the terms of this
Agreement or act contrary to its terms in any way. Further, if a Party’s Affiliate breaches any
aspect of this Agreement performance of which has been delegate to such Affiliate or acts in any
way inconsistently with the foregoing sentence, then the other Party shall be entitled to proceed
against the Party whose Affiliate so breached, and shall not first be required to proceed against
the Affiliate that so breached.

     14.7 Publicity. Except for the details in the press release to be agreed upon by the
Parties, and as required by law, stock exchange or regulatory authority, except to the extent
otherwise required by law or regulation, neither Party, nor any of its Affiliates, shall originate
any publicity, news release or other public announcement, written or oral, relating to the
confidential terms or conditions contained in this Agreement without the prior written approval of
the other Party.

     14.8 Amendment. The Parties hereto may amend, modify or after any of the provisions
of this Agreement, but only by a written instrument that explicitly refers to this Agreement and is
duly executed by both Parties hereto.

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-29-

 

     14.9 Entire Agreement. This Agreement contains the entire understanding of the
Parties with respect to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made with respect to such subject matter are
expressly superceded by this Agreement.

     14.10 Waiver. The failure of a Party to enforce at any time for any period any of
the provisions hereof shall not be construed as a waiver of such provisions or of the rights of
such Party thereafter to enforce each such provisions.

     14.11 No Implied Licenses. Except as expressly and specifically provided under this
Agreement, the Parties agree that neither Party is granted any implied rights to or under any of
the other Party’s current or future patents, trade secrets, copyrights, moral rights, trade or
service marks, trade dress, or any other intellectual property rights.

     14.12 No Joint Venture. The Parties agree that the relationship of Roche and Miikana
established by this Agreement is that of independent licensee and licensor. Furthermore, the
Parties agree that this Agreement does not, is not intended to, and shall not be construed to,
establish a partnership or joint venture, and nor shall this Agreement create or establish an
employment, agency or any other relationship. Except as may be specifically provided herein,
neither Party shall have any right, power or authority, nor shall they represent themselves as
having any authority to assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any
purpose.

     14.13 No Third Party Beneficiaries. All rights, benefits and remedies under this
Agreement are solely intended for the benefit of Roche and Miikana, and no Third Party shall have
any rights whatsoever to (i) enforce any obligation contained in this Agreement; (ii) seek a
benefit or remedy for any breach of this Agreement; or (iii) take any other action relating to this
Agreement under any legal theory, including but not limited to, actions in contract, tort
(including but not limited to negligence, gross negligence and strict liability), or as a defense,
setoff or counterclaim to any action or claim brought or made by the Parties.

     14.14 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR ANY OTHER
INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND, EVEN If SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES. IN NO CASE SHALL EITHER PARTY BE
LIABLE FOR ANY REPRESENTATION OF WARRANTY MADE BY THE OTHER PARTY TO ANY THIRD PARTY.

     14.15 Governing Law. This Agreement is to be construed in accordance with, and
governed by, Swiss law, except in relation to the principles governing conflict of laws. This
Agreement shall not be governed by the United Nations Convention of International Contracts on the
Sale of Goods (Vienna Convention), except that questions affecting the construction and effect of
any patent shall be determined by the laws of the country in which such patent has been

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-30-

 

granted. Litigation relating to the subject matter of this Agreement shall be brought in a
court in Basel, Switzerland.

     14.16 Headings. The article, section and paragraph headings contained in this
Agreement are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.

     14.17 Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall constitute one and the
same document.

     14.18 Dispute Resolution. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to either Party’s rights
and/or obligations hereunder. The Parties shall seek to amicably resolve disputes arising under
this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To
reach amicable resolution, the Parties agree to refer such disputes to the senior management of
each Party for them to seek joint resolution before resorting to litigation.

Remainder of this page intentionally left blank

     In Witness Hereof, the Parties have executed this Agreement effective as of the Effective
Date.

	 	 	 	 	 	 	 	 	 	 	 
	Hoffmann-La Roche Inc.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Hoffmann La-Roche Inc.	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	Name:	 	 	 	 	 	 	 	 
	 

	 	Title:	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	F. Hoffmann-La Roche Ltd F.	 	Hoffmann-La Roche Ltd	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ F. Hoffmann-La Roche Ltd.
	 	 
	 	By:
	 	/s/ F. Hoffmann-La Roche Ltd
	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 

	 	Name:
	 	 	 	 	 	Name:	 	 
	 

	 	Title:
	 	 	 	 	 	Title:	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Miikana Therapeutics Inc.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Dinesh V. Patel	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	Name: Dinesh V. Patel, Ph.D.	 	 	 	 	 	 	 	 
	 

	 	Title: President	 	 	 	 	 	 	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-31-

 

Appendix A

List of Roche Patent Rights

                                        

	 	 	 	 	 
	Count Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

 

	 	 	 	 	 
	Count Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-2-

 

Appendix A

List of Roche Patent Rights (continued)

Roche Patent Series 20077

	 	 	 	 	 
	Count Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request
for confidential treatment and filed separately with the
Securities Exchange Commission.

-3-

 

	 	 	 	 	 
	Count Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

-4-

 

	 	 	 	 	 
	Count Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a
request for confidential treatment and filed separately
with the Securities Exchange Commission.

-5-

 

Appendix A

List of Roche Patent Rights (continued)

                                        

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-6-

 

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-7-

 

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-8-

 

Appendix A

List of Roche Patent Rights (continued)

Roche Patent Series 20524

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-9-

 

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-10-

 

Appendix A

List of Roche Patent Rights (continued)

Roche Patent Series 20690

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-11-

 

Appendix A

List of Roche Patent Rights (continued)

Roche Patent Series 20798

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-12-

 

Appendix A

List of Roche Patent Rights (continued)

Roche Patent Series 20865

	 	 	 	 	 
	Country Code	 	Application No.	 	Patent No.
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*	 	 
	*
	 	*
	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

-13-

 

APPENDIX B

Transfer of Know How

                                                            

	 	 	 	 	 	 	 
	Binder No./Color	 	Description	 	Date	 	HLR No.
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*	 	 
	*

	 	*
	 	*	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*

 

 

	 	 	 	 	 	 	 
	Binder No./Color	 	Description	 	Date	 	HLR No.
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*	 	 	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*
	 	*	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*

	 	*	 	 	 	 
	*

	 	*
	 	*
	 	*
	*

	 	*
	 	*
	 	*
	*
	 	 	 	 	 	 

	 	 	 
	Green Corner Report	 	 
	No./Binder No.	 	Description
	*
	 	 
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential treatment
and filed separately with the Securities Exchange Commission.

2

 

	 	 	 
	*

	 	*
	*

	 	*
	*
	 	 
	*

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	*

	 	*
	 

	 	*
	 

	 	*
	*

	 	*
	 

	 	*
	 

	 	*
	                    

	 	*

	 	 	 
	Binder No./Color	 	Description
	*

	 	*
	*

	 	*
	*
	 	 

	 	 	 
	Binder No./Color	 	Description
	*

	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for
confidential treatment and filed separately with the Securities Exchange Commission.

3

 

	 	 	 
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*1
	*
	 	 
	*
	 	 

	 	 	 
	Binder No./Color	 	Description
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*
	 

	 	*

 

			
	1	 	 

 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

4

 

Appendix C

Development Plan

Phase 2:

	 	 	 	 	 	 	 
	Ø	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	Ø	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	Ø	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	Ø	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	Ø	 	     *
	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	*

	 	 	*
	 	 	*
	 	 	*
	 	 	*
 	 
	 	*

	 	 	*
	 	 	*
	 	 	*
	 	 	*
 	 
	 

 

 

	 	 	 	 	 	 	 	 	 
	     *
	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 
	Phase 1b/ co-administration \trials
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	     
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	     
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	     
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	     
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	Ø	 	     *
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

 

 

	 	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 

	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 
	 	 	Ø	 	     *
	 	 	 	 	 
	 

	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 
	Ø	 	     *
	 	 	 
	 

	 	 	 	Ø
	 	     *
	 

	 	 	 	 	 	 
	Ø	 	     *
	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	*

	 	 	*
	 	 	*
	 	 	*
	 	 	*
 	 
	 	*

	 	 	*
	 	 	*
	 	 	*
	 	 	*
 	 
	 

	 	 	 	 	 	 	 
	     *
	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	o
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

 

 

	 	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	     *
	 
	 
	 	 	 	 	 	 
	o	 	 	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	o	 	 	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	o	 	 	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	     *
	 
	 
	 	 	 	 	 	 
	o	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	§
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	§
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	§
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	§
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	§
	 	     *
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	o	 	     *
	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	o	 	     *
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

 

 

Glossary Of Abbreviations

	 	 	 
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*
	*

	 	*

 

			
	*	 	The marked portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange Commission.

 

 

Appendix D

Active Compound Specifications

 

 

Appendix E

Stock Purchase Agreement

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00103-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00103-of-00352.parquet"}]]