Exhibit 10.1





EXHIBIT 10.1




*** PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. SUCH OMISSIONS ARE INDICATED BY “***”WHERE MATERIAL HAS BEEN SO OMITTED. A COPY OF
THIS EXHIBIT THAT CONTAINS THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.



License and Supply Agreement




among




EpiCept Corporation,




EpiCept GmbH




and




MEDA AB




January 8, 2010



 


 









 





Table of Contents




	 	 	 	 	 
	 	 	Page	 
	 
	1. Definitions
	 	 	1	 
	1.1 Affiliate
	 	 	1	 
	1.2 AML Remission Treatment
	 	 	1	 
	1.3 Ceplene
	 	 	1	 
	1.4 Ceplene Trademarks
	 	 	1	 
	1.5 cGMP
	 	 	2	 
	1.6 Commercially Reasonable Efforts
	 	 	2	 
	1.7 Competing Product
	 	 	2	 
	1.8 Confidential Information
	 	 	2	 
	1.9 Control
	 	 	2	 
	1.10 Derivative
	 	 	2	 
	1.11 EMEA
	 	 	2	 
	1.12 EpiCept Know-How
	 	 	2	 
	1.13 EpiCept Patents
	 	 	2	 
	1.14 EpiCept Product Registration Data
	 	 	3	 
	1.15 EpiCept Technology
	 	 	3	 
	1.16 European Union
	 	 	3	 
	1.17 Field
	 	 	3	 
	1.18 First Commercial Sale
	 	 	3	 
	1.19 Fiscal Net Sales
	 	 	3	 
	1.20 Fiscal Year
	 	 	3	 
	1.21 GCP
	 	 	3	 
	1.22 Improvements
	 	 	4	 
	1.23 Information
	 	 	4	 
	1.24 License
	 	 	4	 
	1.25 Named Patient Program
	 	 	4	 
	1.26 Net Sales
	 	 	4	 






 


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Table of Contents
(continued)





	 	 	 	 	 
	 	 	Page	 
	 
	1.27 Patents
	 	 	4	 
	1.28 Post Approval Commitments
	 	 	4	 
	1.29 Pricing and Reimbursement Approvals
	 	 	5	 
	1.30 Product
	 	 	5	 
	1.31 Regulatory Approval
	 	 	5	 
	1.32 Regulatory Authority
	 	 	5	 
	1.33 Supply Agreement
	 	 	5	 
	1.34 Term
	 	 	5	 
	1.35 Territory
	 	 	5	 
	1.36 Third Party
	 	 	5	 
	1.37 Valid Claim
	 	 	5	 
	2. License Grants
	 	 	6	 
	2.1 License
	 	 	6	 
	2.2 Trademarks
	 	 	6	 
	2.4 Improvements
	 	 	7	 
	2.5 Retained Rights; Negative Covenant
	 	 	8	 
	2.6 No Implied Licenses
	 	 	8	 
	3. Development, Commercialization and Supply
	 	 	9	 
	3.1 Regulatory Matters
	 	 	9	 
	3.2 Development and Commercialization Oversight
	 	 	10	 
	3.3 Collection and Exchange of Pharmacovigilance Data
	 	 	11	 
	3.4 MEDA Commercialization Activities
	 	 	11	 
	3.5 Agreement regarding Manufacturing and Supply
	 	 	12	 
	4. Fees and Payments
	 	 	12	 
	4.1 Upfront Fee
	 	 	12	 
	4.2 Royalties
	 	 	12	 
	4.3 Sales Performance and Other Milestones
	 	 	13	 
	4.4 Supply Pricing
	 	 	13	 






 


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Table of Contents
(continued)





	 	 	 	 	 
	 	 	Page	 
	 
	5. Payment; Records; Audits
	 	 	14	 
	5.1 Payment; Reports
	 	 	14	 
	5.2 Exchange Rate; Manner and Place of Payment
	 	 	14	 
	5.3 Income Tax Withholding
	 	 	14	 
	5.4 Audits
	 	 	15	 
	5.5 Late Payments
	 	 	15	 
	6. Intellectual Property
	 	 	15	 
	6.1 Patent Prosecution and Maintenance
	 	 	15	 
	6.2 Cooperation of the Parties
	 	 	15	 
	6.3 Infringement by Third Parties
	 	 	16	 
	6.4 Infringement of Third Party Rights
	 	 	16	 
	7. Representations and Warranties
	 	 	17	 
	7.1 Mutual Representations and Warranties
	 	 	17	 
	7.2 EpiCept
	 	 	17	 
	7.3 MEDA
	 	 	19	 
	7.4 Disclaimer
	 	 	19	 
	7.5 Limitation of Liability
	 	 	19	 
	8. Confidentiality
	 	 	20	 
	8.1 Confidential Information
	 	 	20	 
	8.2 Permitted Use
	 	 	20	 
	8.3 Publications
	 	 	21	 
	8.4 Publicity
	 	 	21	 
	9. Term and Termination
	 	 	22	 
	9.1 Term
	 	 	22	 
	9.2 Termination by Mutual Agreement
	 	 	22	 
	9.3 Termination by Meda
	 	 	22	 
	9.4 Termination for Cause
	 	 	22	 
	9.5 Effects of Termination
	 	 	23	 






 


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Table of Contents
(continued)





	 	 	 	 	 
	 	 	Page	 
	 
	10. Indemnification
	 	 	24	 
	10.1 MEDA
	 	 	24	 
	10.2 EpiCept
	 	 	25	 
	10.3 Procedure
	 	 	25	 
	10.4 Insurance
	 	 	26	 
	11. Dispute Resolution
	 	 	26	 
	11.1 Dispute Resolution
	 	 	26	 
	11.2 Arbitration
	 	 	26	 
	11.3 Court Actions
	 	 	27	 
	11.4 Continued Performance
	 	 	27	 
	12. Miscellaneous
	 	 	27	 
	12.1 Governing Law
	 	 	27	 
	12.2 Entire Agreement; Amendment
	 	 	27	 
	12.3 Relationship Between the Parties
	 	 	27	 
	12.4 Non-Waiver
	 	 	28	 
	12.5 Assignment
	 	 	28	 
	12.6 No Third Party Beneficiaries
	 	 	28	 
	12.7 Severability
	 	 	28	 
	12.8 Notices
	 	 	29	 
	12.9 Force Majeure
	 	 	29	 
	12.10 Interpretation
	 	 	30	 
	12.11 Further Assurances
	 	 	30	 
	12.12 Counterparts
	 	 	30	 





 


-iv-









 





LICENSE AND SUPPLY AGREEMENT




This License and Supply Agreement (the “Agreement”) is entered into as of January 8,
2010 (the “Effective Date”) by and among MEDA AB, a company organized under the laws of Sweden
(“MEDA”), having its principal offices at Box 906, SE-170 09, Solna, Sweden, EpiCept
Corporation, a corporation organized under the laws of the State of Delaware, USA and having
its principal offices at 777 Old Saw Mill Road, Tarrytown, New York 10591, USA and its
wholly-owned subsidiary, EpiCept GmbH, a corporation organized under the laws of Germany
(collectively, “EpiCept”).



Recitals




Whereas, EpiCept owns certain proprietary technology and information related to a
proprietary compound named Ceplene® (histamine dihydrochloride);



Whereas, MEDA desires to obtain an exclusive license from EpiCept to commercialize
products containing Ceplene in the Territory; and



Whereas, EpiCept desires to grant MEDA such licenses, on the terms and subject to the
conditions of this Agreement.



Agreement




Now, Therefore, in consideration of the foregoing premises and the mutual covenants
contained herein and other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the parties agree as follows:



1. Definitions. Capitalized terms used in this Agreement, whether used in the singular
or plural, shall have the meanings set forth below, unless otherwise specifically indicated
herein.



1.1 “Affiliate” shall mean any company or entity controlled by, controlling, or under common
control with a party hereto. For the purpose of this definition, a business entity shall be deemed
to “control” another business entity, if it owns directly or indirectly, more than 50% of the
outstanding voting securities, capital stock, or other comparable equity or ownership interest of
such business entity, or exercises equivalent influence over such entity.



1.2 “AML Remission Treatment” shall mean the treatment of adult patients with acute myeloid
leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).



1.3 “Ceplene” shall mean any chemical composition comprising or containing histamine
dihydrochloride (2-(3H-imidazol-4-yl)ethylnamine dihydrochloride).




1.4 “Ceplene Trademarks” shall mean the Ceplene® trademarks that are identified on Exhibit D.


 


 









 





1.5 “cGMP” shall mean current good manufacturing practices applicable to the manufacture,
labeling, packaging, handling, storage, supply and transport into the Territory of Products,
including any applicable regulations, policies and guidelines promulgated pursuant to “The Rules
Governing Medicinal Products in the European Community”, volume IV, “Guide to good manufacturing
practice for medicinal products.”



1.6 “Commercially Reasonable Efforts” shall mean efforts that are consistent with the usual
practice followed by major specialty pharmaceutical companies of a size similar to MEDA’s in
pursuing the development and commercialization of pharmaceutical products in the Territory with
similar market potential and at a similar stage in development.



1.7 “Competing Product” shall mean any pharmaceutical product containing Ceplene or a
Derivative which is used or can be used as a substantially equivalent substitute to the Product in
its approved indications in the Territory.




1.8 “Confidential Information” shall have the meaning provided in Article 8.



1.9 “Control” shall mean, with respect to any Information, Patents or other intellectual
property rights, possession by a party of the right, power and authority (whether by ownership,
license or otherwise, other than pursuant to this Agreement) to grant access to, to grant use of,
or to grant a license or a sublicense to such Information, Patents or intellectual property rights
without violating the terms of any agreement or other arrangement with any Third Party.



1.10 “Derivative” shall mean, with respect to Ceplene, any metabolite, prodrug, hydrate,
solvate, conjugate, salt, crystal form, ester, enantiomer, isomer or polymorph of Ceplene.



1.11 “EMEA” shall mean the European Medicines Agency or any successor entity thereof
performing similar functions.



1.12 “EpiCept Know-How” shall mean all Information and Improvements owned or Controlled by
EpiCept as of the Effective Date or during the Term that is necessary or useful for the
registration, development, promotion, marketing, sale or distribution of Products in the Field in
the Territory, excluding EpiCept Patents.



1.13 “EpiCept Patents” shall mean Patents owned or Controlled by EpiCept or any of its
Affiliates as of the Effective Date or during the Term that, in the absence of a license
thereunder, would be infringed by the development, use, sale, offer for sale or import of Products
in the Field in the Territory. The EpiCept Patents as of the Effective Date are set forth on
Exhibit A.


 


2









 





1.14 “EpiCept Product Registration Data” means (i) all regulatory files relating thereto,
including any licenses (to the extent transferable), and minutes of meetings and telephone
conferences with any Regulatory Authorities, validation data, preclinical and clinical studies and
tests related to the Product including original data, case report forms, study files relating to
the aforementioned studies and tests, and all audit reports of clinical studies, plus all
applications (and amendments thereto) for Regulatory Approvals, annual reports and safety reports
associated therewith, drug master files, which are in EpiCept’s or its Affiliates’ possession or
Control, and all correspondence with Regulatory Authorities regarding the marketing status of the
Product; and (ii) all records maintained under cGMPs or other record keeping or reporting
requirements of Regulatory Authorities in the Territory, including all correspondence and
communications with Regulatory Authorities in connection with the Product (including any
advertising and promotion documents), adverse event files, complaint files, manufacturing records.




1.15 “EpiCept Technology” shall mean the EpiCept Patents and EpiCept Know-How.



1.16 “European Union” shall means Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United
Kingdom, and any such other country or territory that may officially become part of the European
Union after the Effective Date.




1.17 “Field” shall mean all uses for any human indication, disease, disorder or condition.



1.18 “First Commercial Sale” shall mean, with respect to a Product, the first sale (as
evidenced by an invoice or receivable) by MEDA or its Affiliates to a Third Party for end use or
consumption of such Product in a country in the Territory after the governing Regulatory Authority
of such country has granted all Regulatory Approvals necessary to market and sell Products in such
country. Sale of Product by MEDA to its Affiliate shall not constitute a First Commercial Sale
unless such Affiliate is the end user of the Product.




1.19 “Fiscal Net Sales” shall mean Net Sales achieved during any particular Fiscal Year.




1.20 “Fiscal Year” shall mean January 1 through December 31, representing MEDA’s fiscal year.



1.21 “GCP” means all applicable good clinical practice standards for the design, conduct,
monitoring, auditing, recording, analyses and reporting of clinical trials, including, as
applicable, (a) as set forth in European Commission Directive 2001/20/EC relating to the
implementation of good clinical practice in the conduct of clinical trials on medicinal products
for human use, and brought into law by European Commission Directive 2005/28/EC laying down the
principles and detailed guidelines for good clinical practice for investigational medicinal
products, (b) the International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good
Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials
on medicinal products in the EU, (d) U.S. C.F.R Title 21, Parts 50, 56 and 312, as may be amended
from time to time, and (v) the equivalent applicable laws in any relevant country.


 


3









 





1.22 “Improvements” shall mean any and all developments, inventions or discoveries relating to
the EpiCept Technology developed or acquired by, or under the Control of, a party at any time
during the Term and shall include such developments intended to enhance the safety, efficacy or
uses (including additional indications) of the Product.



1.23 “Information” shall mean tangible and intangible techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience,
test data and results (including pharmacological, toxicological and clinical test data and
results), analytical and quality control data, results, descriptions and compositions of matter.




1.24 “License” shall have the meaning provided in Section 2.1.



1.25 “Named Patient Program” shall mean a program that facilitates patient access to
medications that are not licensed for marketing or are commercially unavailable in the country
where a patient is receiving treatment if no suitable alternative is available or exists in such
country. Physicians request the medication on behalf of a specific “named” patient.



1.26 “Net Sales” shall mean the gross amounts invoiced by MEDA and its Affiliates for sales of
Product to Third Parties that are not Affiliates of MEDA or its Affiliates, less the following
items, as allocable to such Products (if not previously deducted from the amount invoiced):
(a) ordinary and customary trade discounts actually allowed; (b) credits, rebates and returns
(including wholesaler and retailer returns and rebates and retroactive price reductions granted to
managed health care organizations and governmental authorities) actually allowed or granted;
(c) freight, postage, insurance and duties paid for and separately identified on the invoice or
other documentation maintained in the ordinary course of business, and (d) excise taxes, other
consumption taxes, customs duties and compulsory payments to governmental authorities actually paid
and separately identified on the invoice or other documentation maintained in the ordinary course
of business. If Product is sold or transferred between or among MEDA and any of its Affiliates for
such entity’s own use, then the amount used to calculate Net Sales with respect to such sale or
transfer shall be deemed to be the amount that would be invoiced to Third Parties (other than
Affiliates of MEDA or its Affiliates) in an arm’s-length transaction. For the avoidance of doubt,
if MEDA receives compensation for the Product that is made available to patients in the Territory
through a Named Patient Program, expanded-access program, compassionate-use program, or any other
similar program, then such compensation is also considered as Net Sales for the purpose of this
Agreement.



1.27 “Patents” shall mean patents and patent applications, including provisional applications,
continuations, continuations-in-part, continued prosecution applications, divisions, substitutions,
reissues, additions, renewals, reexaminations, extensions, term restorations, confirmations,
registrations, revalidations, revisions, priority rights, requests for continued examination and
supplementary protection certificates granted in relation thereto, as well as utility models,
innovation patents, petty patents, patents of addition, inventor’s certificates, and equivalents in
any country or jurisdiction.



1.28 “Post Approval Commitments” shall mean the clinical studies agreed by EpiCept as part of
the marketing authorization under exceptional circumstances as granted by the European Commission
for Ceplene, which are detailed in Exhibit B.


 


4









 





1.29 “Pricing and Reimbursement Approvals” means any pricing and reimbursement approvals which
are required to be obtained before placing the Product on the market in a particular jurisdiction
in the Territory.



1.30 “Product” shall mean a pharmaceutical product that is or contains (i) Ceplene and/or (ii)
if relating to AML Remission Treatment only, Ceplene or a Derivative, and, in both cases, line and
label extensions thereof, including all formulations, routes of administration and other
Improvements made or acquired by EpiCept, in all cases, whether administered alone or in
combination with other pharmaceutical products or active pharmaceutical ingredients.



1.31 “Regulatory Approval” shall mean any and all approvals (including Pricing and
Reimbursement Approvals), licenses, registrations, or authorizations of any country, federal,
supranational, state or local regulatory agency, department, bureau or other government entity in
the Territory that are necessary for the development, use, importation, promotion, marketing, sale
and distribution of Products in any part of the Territory.



1.32 “Regulatory Authority” shall mean any country, federal, supranational, state or local
regulatory agency, department, bureau, court or other governmental or regulatory authority having
the authority to regulate the development or marketing of pharmaceutical products in the Territory
or any part thereof (e.g., the Swedish Ministry of Health and Social Affairs or the EMEA).



1.33 “Supply Agreement” shall have the meaning provided in Section 3.5.



1.34 “Term” shall have the meaning provided in Section 9.1.



1.35 “Territory” shall mean the counties listed in Exhibit C.



1.36 “Third Party” shall mean any entity other than MEDA or EpiCept or an Affiliate of MEDA or
EpiCept.



1.37 “Valid Claim” shall mean a claim: (i) in any issued, unexpired Patent which has not been
donated to the public, permanently revoked or held unenforceable or invalid by a governmental
agency or court of competent jurisdiction by a decision from which there is no appeal or (if there
is a right to appeal) from which the period for appeal has expired without such appeal, and that
has not been disclaimed or admitted to be invalid, or unenforceable through reexamination, reissue,
disclaimer or otherwise, or (ii) in any United States or foreign patent application among the
Patents, which shall not have been finally cancelled, withdrawn or abandoned by any administrative
agency or other body of competent jurisdiction. For purposes of this Section 1.30, a pending
patent application shall be deemed to have been abandoned as of the date four (4) years subsequent
to the earliest filing date asserted for such application (“Constructive Abandonment Date”), and
the claims of such application shall no longer constitute Valid Claims as of such Constructive
Abandonment Date.


 


5









 





2. License Grants.




2.1 License. Subject to the terms and conditions of this Agreement, EpiCept hereby grants to
MEDA, during the Term, an exclusive, royalty bearing license under the EpiCept Technology solely to
develop, use, sell, have sold, offer for sale, import, register, promote, market, and distribute
Products in the Field in the Territory (the “License”). The License shall include the right to
grant and authorize sublicenses to Affiliates of MEDA and distributors appointed by MEDA to the
extent necessary to market and distribute Products in the Field in the Territory.




2.2 Trademarks.



(a) Ceplene Trademarks. All packaging, labeling, advertising and promotional material used by
MEDA and its Affiliates in connection with any Product, shall feature the Ceplene Trademarks and,
to the extent permitted by law, EpiCept’s corporate tradename and logo. EpiCept shall maintain all
Ceplene Trademarks in good standing. Subject to the terms and conditions of this Agreement, EpiCept
hereby grants to MEDA an exclusive, royalty-free license, with the right to sublicense only to its
Affiliates and distributors, to use the Ceplene Trademarks solely in connection with the use, sale,
importation, distribution and marketing of the Product in the Field in the Territory, including the
use of the Ceplene Trademarks on Product packaging, labeling, advertising and promotional material.
EpiCept or an Affiliate of EpiCept shall retain the ownership of the entire right, title and
interest in and to the Ceplene Trademarks, and all goodwill associated with or attached to the
Ceplene Trademarks arising out of the use thereof by MEDA and its Affiliates shall inure to the
benefit of EpiCept. MEDA agrees that it will not contest, oppose or challenge EpiCept’s ownership
of the Ceplene Trademarks. MEDA agrees that it will not at any time do or suffer to be done any
act or thing that will in any way impair EpiCept’s ownership of or rights in and to the Ceplene
Trademarks or any registration thereof or that may depreciate the value of the Ceplene Trademarks
or the reputation of EpiCept. MEDA agrees that in using Ceplene Trademarks upon any Product
packaging, labeling, advertising or promotional materials, it will not represent in any way that it
has any right or title to the ownership of the Ceplene Trademarks or the registration thereof.
MEDA shall obtain the prior written approval of EpiCept (which shall not be unreasonably withheld
or delayed) of the form and manner in which the Ceplene Trademarks will be used upon, in connection
with, or in relation to, the Products, or any packaging, labels, containers, advertisements and
other materials related thereto. Wherever any Ceplene Trademark is used, e.g., on any package,
label or advertisement, the first or most prominent use shall, to the extent permitted by law,
always be accompanied by a legend acceptable to EpiCept indicating that the Product utilizes the
proprietary technology of EpiCept and that the Ceplene Trademarks are licensed to MEDA by EpiCept.
MEDA shall, at EpiCept’s request and expense, assist EpiCept in any action reasonably necessary or
desirable to protect the Ceplene Trademarks used or proposed to be used hereunder. MEDA shall as
soon as practicable notify EpiCept of any apparent infringement by a Third Party of any of the
Ceplene Trademarks. Notwithstanding the foregoing, during the Term EpiCept shall have the right to
use the Ceplene Trademarks in the Territory for corporate purposes, but will not engage in
promotional or marketing activities of the Product in the Territory without the prior written
consent of MEDA. EpiCept will also retain all rights to use the Ceplene Trademarks outside the
Territory.


 


6









 





(b) Quality Control. MEDA agrees to cooperate with EpiCept to enable EpiCept to control the
nature and quality of the use of the Ceplene Trademarks such that EpiCept may verify that the use
of the Ceplene Trademarks is consistent with the agreed quality standards and Product
specifications.



2.3 Delivery of EpiCept Know-How. Within 60 days following the Effective Date (and promptly
after the development or acquisition of any EpiCept Know-How thereafter), EpiCept shall provide to
MEDA all tangible embodiments of the EpiCept Know-How in EpiCept’s possession (or copies thereof)
as reasonably necessary for the practice of the License.




2.4 Improvements.



(a) Meda Improvements. The parties acknowledge and agree that all right, title, and interest
in and to any Improvements developed, acquired or Controlled by or on behalf of MEDA, its
Affiliates or sublicensees during the Term (the “Meda Improvements”) shall, as between the parties
hereto, be owned by and remain the sole property of MEDA; provided, that (a) MEDA shall promptly
disclose any Meda Improvements to the extent specifically relating to the Product to EpiCept and
(b) MEDA shall grant EpiCept a royalty-free, non-exclusive license to practice such Meda
Improvements to develop and commercialize Products outside the Territory. EpiCept may grant
sublicenses under the foregoing license to only such Third Party licensees that grant EpiCept
licenses to practice Improvements developed or acquired by such Third Party with the right to
grant MEDA a royalty-free sublicense to practice such Improvements to develop and commercialize
the Products in the Territory. MEDA may, in its sole discretion, file and prosecute in its own
name and at its own expense, Patents claiming any Meda Improvements.



(b) EpiCept Improvements. The parties acknowledge and agree that all right, title, and
interest in and to any Improvements developed, acquired or Controlled by or on behalf of EpiCept
or its Affiliates during the Term (the “EpiCept Improvements”) shall, as between the parties
hereto, be owned by and remain the sole property of EpiCept; provided, that (a) EpiCept shall
promptly disclose any EpiCept Improvements to the extent specifically relating to the Product to
MEDA and (b) EpiCept shall grant MEDA an exclusive license (with right to sublicense its
Affiliates and distributors) to practice such EpiCept Improvements to develop and commercialize
Products in the Territory, at no additional royalty cost than as otherwise provided under this
Agreement. MEDA may grant sublicenses under the foregoing license to only such Third Party
licensees (if permitted by this Agreement) that grant MEDA licenses to practice Improvements
developed or acquired by such Third Party with the right to grant EpiCept a royalty-free
sublicense to practice such Improvements to develop and commercialize the Products outside the
Territory. EpiCept may, in its sole discretion, file and prosecute in its own name and at its own
expense, Patents claiming any EpiCept Improvements.


 


7









 





(c) Joint Improvements. The parties acknowledge and agree that all right, title, and
interest in and to any Improvements developed, acquired or Controlled jointly by or on behalf of
the parties or their respective Affiliates or permitted sublicensees (in the case of MEDA) during
the Term (the “Joint Improvements”) shall, as between the parties hereto, be owned by and remain
the sole property jointly of EpiCept and MEDA. EpiCept shall have the exclusive right to practice
such Joint Improvements to develop and commercialize Products outside the Territory, and MEDA
shall have the exclusive right to practice such Joint Improvements to develop and commercialize
Products within the Territory. Each party shall have the right to exploit the Joint Improvements
in any manner that is not inconsistent with the rights granted the other party under this
Agreement, in each case, without the consent of, or an accounting to, the other party; provided,
that neither party shall assign its rights in any Joint Improvements without the other party’s
prior written consent, such consent not to be unreasonably withheld or delayed.The parties agree
to keep each other informed of such Joint Improvements and agree on a course for obtaining patent
protection, if warranted. The JCC will compile a quarterly report summarizing all such Joint
Improvements.



2.5 Retained Rights; Negative Covenant. EpiCept hereby expressly reserves the right to
practice, and to grant licenses under, the EpiCept Technology for any and all purposes other than
the specific purposes for which MEDA has been granted the License. Without limiting the generality
of the foregoing, EpiCept exclusively reserves to itself the right under the EpiCept Technology to
make or have made Ceplene and/or Products throughout the world, and MEDA shall have no right under
any EpiCept Technology to make or have made Ceplene or any Product. MEDA hereby agrees that it
will not, and it will not permit or cause any Affiliate or other Third Party to, practice any
EpiCept Technology for any purpose other than as expressly authorized in this Agreement.



2.6 No Implied Licenses. No right or license under any Patents or Information of either party
is granted or shall be granted by implication. All such rights or licenses are or shall be granted
only as expressly provided in this Agreement. EpiCept hereby expressly reserves the right to
practice, and to grant licenses under, the EpiCept Technology for any and all purposes other than
the specific purposes for which the MEDA has been granted the License.


 


8









 





3. Development, Commercialization and Supply.




3.1 Regulatory Matters.



(a) Regulatory Approvals in the Territory. EpiCept, at its sole expense, shall use
commercially reasonable efforts to obtain any and all applicable Regulatory Approvals, other than
the Pricing and Reimbursement Approvals, for the Product in the Field in all countries in the
European Union, Norway and Iceland. MEDA, at its sole expense, shall use commercially reasonable
efforts to obtain any and all applicable Regulatory Approvals for the Product for AML Remission
Treatment in all other countries in the Territory. Regulatory Approvals in the European Union
shall be owned by EpiCept (or one of its Affiliates), except to the extent required by law to be
held by the distributor or if EpiCept (or one of its Affiliates) is otherwise not eligible to hold
such Regulatory Approval in its name. Such Regulatory Approvals in the European Union that are not
held in the name of EpiCept (or one of its Affiliates) and all Regulatory Approvals in other
countries in the Territory shall be owned by and held in the name of MEDA (or one of its
Affiliates or distributors). The holder of the Regulatory Approval in any country is referred to
as the “MAH.” The applicable MAH in each country shall be responsible for compliance with all
obligations in respect of such Regulatory Approvals, including the filing of all annual and other
reports or filings required by applicable Regulatory Authorities with respect to Products and
shall maintain any and all such Regulatory Approvals in such country during the Term, including
obtaining any supplemental applications, variations or renewals thereof necessary to sell the
Products for all indications for which a Product is developed. MEDA shall be responsible for
obtaining all Pricing and Reimbursement Approvals for Products in the Territory during the Term.
Each party shall cooperate with the other party in good faith in connection with obtaining and
maintaining all Regulatory Approvals as described in this Section 3.1(a), including, in the case
of EpiCept, providing all EpiCept Product Registration Data and other information reasonably
requested by MEDA to prepare applications for Regulatory Approvals and assisting MEDA in
responding to any inquiries from Regulatory Authorities. As soon as reasonably practicable
following the filing of any annual report or filing, application, supplemental application,
variation, renewal or other materials with a Regulatory Authority (a “Submission”), each party
shall transfer to the other party copies of, and allow the other party to cross-refer to, such
Submission relating to Products and provide reasonable access to all associated supporting
documents and Information for use in those countries in the Territory where such other party is
the MAH, including providing appropriate notification of such other party’s access and reference
rights to the Regulatory Authorities, including an informed consent letter under Article 10c of
Directive 2001/83/EC as amended. If it is not possible for a party to cross-reference a
Submission made by the other party, the other party will provide the party with access to all
documents and Information associated with its Submission and, to the extent such documents and
Information have not already been transferred, shall transfer copies of such documents and
Information, if requested to do so by such party.


 


9









 





(b) Post-Approval Commitments and Other Activities. EpiCept shall conduct, at its expense,
the Post-Approval Commitments in accordance with GCP and other applicable laws and other
requirements of applicable Regulatory Authorities. MEDA will assist EpiCept in fulfilling the Post
Approval Commitments, including the selection of centers for clinical trials. Should any
Regulatory Authority in the Territory require the conduct of any development activities, other
than the Post-Approval Commitments, with respect to Products as a condition to granting or
maintaining Regulatory Approval of any Product in the Field in the Territory, the parties shall
coordinate the implementation of such development activities, and such activities shall be
conducted solely with EpiCept’s prior written approval of the applicable study design(s) and
protocol(s) for such activities. EpiCept shall be responsible for conducting any such other
required activities, at EpiCept’s sole expense. MEDA shall cooperate with and assist EpiCept in
good faith in connection with the foregoing. MEDA shall have the right to conduct in the
Territory, at its expense, such Phase IV and other clinical studies as it determines are desired
to commercialize the Products, including marketing studies and clinical studies to expand the
label.



(c) Label Extension Studies. EpiCept shall use commercially reasonable efforts to conduct
the clinical studies described in Exhibit E, which are intended to expand the uses of the Product.
Such studies shall be conducted in accordance GCP and other applicable laws and the protocols
approved by the JCC. EpiCept shall periodically provide updates to MEDA regarding clinical and
non-clinical data, and other results and analyses with respect to such studies, including all
reports from clinical investigators and such other information as MEDA may reasonable request. If
the JCC determines that the results of any such study would support a variation or other amendment
to expand the indications of use of the approved labeling for the Product and that such expansion
is otherwise desired, EpiCept shall prepare such variation, amendment or other submission to seek
all applicable Regulatory Approvals to so expand the labeling. The MAH shall then use its
commercially reasonable efforts to seek to obtain such Regulatory Approvals.



(d) Other Development and Regulatory Activities. EpiCept shall promptly provide MEDA with
all information regarding the development and registration of the Product in each country in the
Territory for which EpiCept is responsible for obtaining and maintaining Regulatory Approvals that
is material to MEDA’s commercialization and marketing activities in such countries. To the extent
legally permitted, EpiCept shall promptly provide MEDA with all copies of all communications with
Regulatory Authorities in advance of submission of any responses to such Regulatory Authorities
and, to the extent reasonably practicable, shall consider in good faith and incorporate MEDA’s
comments therein.



(e) Named Patient Program. EpiCept will terminate on a country by country basis when and as
requested by MEDA the IDIS Named Patient Program conducted under agreements and other arrangements
between EpiCept and IDIS Ltd. (the “IDIS Arrangement”).  




3.2 Development and Commercialization Oversight.



(a) Joint Commercialization Committee. The parties shall within 30 days after the Effective
Date establish a Joint Commercialization Committee (“JCC”), which will be responsible for
discussing all developments of major clinical and commercial relevance, including clinical
activities in connection with development and approval of Products and other related issues. The
JCC shall be responsible for reviewing the Marketing Plan pursuant to Section 3.3a, reviewing
pricing and reimbursement (subject to all applicable laws) and reviewing sales forecasts prepared
in accordance with the Supply Agreement pursuant to Section 3.4. The JCC will be composed of three
voting members appointed by each of MEDA and EpiCept. MEDA shall select one of its voting members
to act as the chairperson of the JCC. EpiCept shall select one of its voting members to act as the
secretary of the JCC.


 


10









 





The JCC will meet at minimum three times per year or with such greater frequency as the JCC agrees.
Meetings may be conducted by telephone conference. The parties will agree upon the time and place
of meetings. Within 15 days after each meeting, the JCC secretary will provide the parties with
the written minutes of such meeting describing, in reasonable detail, the status of the clinical
activities and the commercialization program, a summary of the results and progress to date, the
issues requiring resolution and the agreed resolution of previously reported issues.



(b) Decisions of the JCC. A quorum of the JCC shall be deemed to be present at any meeting if
at least two voting members of each party are present at such meeting in person or via telephone.
All decisions shall be unanimous with each party having one vote. If the JCC is unable to decide
or resolve an issue, MEDA shall have final decision-making authority with respect to all matters
specifically relating to the development and commercialization of Products in the Territory
(including all regulatory matters); provided, that MEDA may not, without EpiCept’s consent (such
consent not to be unreasonably withheld), so determine any matter in a manner that is reasonably
likely to (i) materially increase the scope of EpiCept’s obligations hereunder (including any costs
to be paid by EpiCept) or (ii) expand the scope of the License.



3.3 Collection and Exchange of Pharmacovigilance Data. The parties agree that, commencing
immediately, they will collect and exchange pharmacovigilance data regarding the Product sufficient
to permit each party to comply with its regulatory and other legal obligations. Within 90 days
following the Effective Date, the parties shall enter into a pharmacovigilance agreement governing
the allocation of responsibilities between the parties for obtaining, sharing and reporting all
safety-related data in connection with the commercialization of Products worldwide.




3.4 MEDA Commercialization Activities.



(a) Sales and Marketing Plan. MEDA and, as applicable, its Affiliates shall commercialize
Product in the Field in the Territory in accordance with a marketing and sales plan for Product, as
reviewed by the JCC (the “Marketing Plan”). MEDA shall submit an initial draft of the Marketing
Plan to the JCC within 45 days after the Effective Date. MEDA may amend the Marketing Plan from
time to time; provided, that MEDA first notify the JCC of any such amendment and consider in good
faith the comments of the JCC. Following the Regulatory Approval of the Product in each country in
the Territory, MEDA and, as applicable, its Affiliates shall use Commercially Reasonable Efforts to
commercialize, promote, sell and distribute Product in the Field in the Territory in accordance
with the Marketing Plan. EpiCept, in the course of the meetings of the JCC, shall have the right
to obtain periodic updates as to the status and results of MEDA’s marketing efforts in each country
of the Territory. MEDA agrees to use its Commercially Reasonable Efforts to market the Products in
the Territory in accordance with the Marketing Plan.


 


11









 





(b) Product Pricing. MEDA shall use Commercially Reasonable Efforts to obtain Pricing and
Reimbursement Approvals as soon as possible after Regulatory Approval of a Product in each country
in the Territory.



3.5 Agreement regarding Manufacturing and Supply. EpiCept shall be the exclusive supplier of
all requirements for Product to MEDA and its Affiliates in the Territory for commercial purposes,
in accordance with the binding terms set forth in Exhibit F attached hereto. The parties will
negotiate in good faith a long-form manufacturing and supply agreement containing, at a minimum,
the terms set forth in Exhibit F no later than 45 days from the Effective Date (the “Supply
Agreement”).



4. Fees and Payments.




4.1 Upfront Fee. To partially offset EpiCept’s cost of acquiring Ceplene and to reimburse
EpiCept for expenses incurred in obtaining EMEA marketing approval, MEDA shall pay to EpiCept a
non-refundable, non-creditable upfront fee of US$3,000,000 within five business days after the
Effective Date.




4.2 Royalties.



(a) Royalty Rates. During the Term, MEDA shall pay to EpiCept royalties on Fiscal Net Sales
of Products in the Territory at the following rates:



	 	 	 	 	 
	Territory Fiscal Net Sales of Product	 	Royalty Rate per sales interval	 
	 
	 	 	 	 
	***
	 	 	*	**
	 
	 	 	 	 
	***
	 	 	*	**
	 
	 	 	 	 
	***
	 	 	*	**
	 
	 	 	 	 
	***
	 	 	*	**






Royalties payable under this Section 4.2 shall be paid to EpiCept ***.



(b) Exception. With respect to any country in the Territory, all royalty rates set forth in
Section 4.2(a) shall be reduced to *** of Net Sales (for such country only) upon the first
commercial sale of a Competing Product in such country. Net Sales of Products for which the
reduced royalty is payable shall not be included in calculating the aggregate Territory Fiscal Net
Sales of Product and in determining the applicable royalty percentage for other Fiscal Net Sales
for purposes of Section 4.2(a), but *** of such Net Sales of Products shall be taken into account
for purposes of determining whether the initial sales milestones as provided in Section 4.3 are
satisfied.


 


12









 





(c) Reconsideration of Royalty Rates. If MEDA’s aggregate gross profit margin from Fiscal Net
Sales of Products in the Territory, taken as a whole, for any Fiscal Year falls below *** (without
taking into account the expenses related to the payment by MEDA to EpiCept of any milestone
payments pursuant to Section 4.3), the parties shall renegotiate in good faith an adjustment in the
royalty rates set forth in this Section 4.2 or, if EpiCept elects, the supply price set forth in
the Supply Agreement to restore such minimum aggregate gross profit margin.



(d) Third Party Licenses. EpiCept shall pay all royalties and other payments required to be
paid to all Third Parties in respect of the EpiCept Technology, including to all inventors of any
of the EpiCept Patents.



4.3 Sales Performance and Other Milestones. MEDA shall pay to EpiCept the following milestone
payments within 30 days after the end of the month (or, in the case of milestones (c) and (d), 60
days after the end of the fiscal quarter during which the milestone was attained) in which the
first achievement of the following milestones occur:



	 	 	 	 	 
	Milestone Event	 	Payment	 
	(a) First Commercial Sale of Product in Germany, United
Kingdom, France, Spain or Italy
	 	US$	2,000,000	 
	(b) Regulatory Approval by the EMEA of a change in labeling
in the “Summary of Product Characteristics” of Products to
reflect the removal of the statement “efficacy in patients
older than age 60 has not been fully demonstrated”
(provided that no similar age-limiting language is required
to be added or substituted)
	 	US$	5,000,000	 
	(c) First time that Net Sales of Product in any consecutive
twelve month period equals or exceeds US$50,000,000
	 	US$	10,000,000	 
	(d) First time that Net Sales of Product in any consecutive
twelve month period equals or exceeds US$100,000,000
	 	US$	20,000,000	 






Each of the milestone payments set forth in this Section 4.3 shall be payable only one time, for
the first achievement of the applicable milestone. In addition, in the event more than one
milestone is achieved during a single period, all applicable milestone payments for sales
achievements shall be due at the end of such period. For the avoidance of doubt and by way of
example, if in a twelve month period, the Net Sales equal US$101,000,000, when Net Sales had never
exceeded $50,000,000 in any prior twelve month period, MEDA shall pay to EpiCept US$30,000,000
(US$10,000,000 + US$20,000,000), and if in any succeeding twelve month period, Net Sales equal
US$51,000,000, no milestones payments shall be due for such period. No payments made to EpiCept
pursuant to this Section 4.3 shall be credited against future royalty payments payable by MEDA to
EpiCept under this Agreement.



4.4 Supply Pricing. MEDA shall exclusively purchase Product from EpiCept at a price of ***
per vial subject to adjustment as per Exhibit F, and on the terms and conditions set forth therein
and in the Supply Agreement to be negotiated in accordance with the provisions of Section 3.5.


 


13









 





5. Payment; Records; Audits.




5.1 Payment; Reports. From and after the First Commercial Sale of a Product in the Territory,
MEDA shall furnish to EpiCept a monthly written report for each calendar quarter showing, on a
Product-by-Product basis, the Net Sales of Products and the royalties payable under this Agreement
with respect to such Products in sufficient detail to permit confirmation of the accuracy of the
payment made, including, without limitation and on a country-by-country basis, the gross sales and
Net Sales of Products, any applicable royalty reductions permitted by this Agreement, the royalties
payable (in U.S. dollars), and the method used to calculate the royalties. Royalty reports and
payment of royalties shown to have been accrued by each royalty report shall be due within 60 days
after the close of each calendar quarter.



5.2 Exchange Rate; Manner and Place of Payment. All payments to be made by MEDA to EpiCept
under this Agreement shall be made in United States dollars by wire transfer in immediately
available funds to a bank and account designated in writing by EpiCept, unless otherwise specified
in writing by EpiCept. When conversion of amounts received by MEDA in any foreign currency is
required or for purposes of calculating Fiscal Net Sales in Section 4.3, such conversion shall be
calculated using the rate of exchange that is the commercial rate of exchange for the conversion of
local currency to United States dollars as published by the Financial Times, on the last business
day immediately prior to the date of payment (or if such journal shall cease to publish currency
exchange rates, then the commercial rate of exchange published by another leading financial
publication or bank as mutually agreed to in writing by MEDA and EpiCept).



5.3 Income Tax Withholding. EpiCept shall pay any and all taxes levied on account of any
payment made to it under this Agreement. If any taxes are required to be withheld by MEDA, MEDA
shall (a) deduct such taxes from the payment made to EpiCept, (b) timely pay the taxes to the
proper taxing authority, and (c) send proof of payment to EpiCept, including any receipt issued by
the taxing authority, and certify its receipt by the taxing authority within 60 days following such
payment.


 


14









 





5.4 Audits. During the Term and for a period of three years thereafter, MEDA shall keep, and
shall cause its Affiliates to keep, complete and accurate records pertaining to the sale or other
disposition of Products in sufficient detail to permit EpiCept to confirm the accuracy of all
milestone and royalty payments due hereunder. MEDA shall permit, and cause its Affiliates to
permit, EpiCept to cause an independent, certified public accountant reasonably acceptable to MEDA
to audit such records of MEDA and its Affiliates to confirm Net Sales, and royalty and milestone
payments for a period covering not more than the preceding three years. Such audits may be
exercised during normal business hours upon reasonable prior written notice to MEDA, but no more
frequently than once per year. No accounting period of MEDA or its Affiliate shall be subject to
audit more than one time by EpiCept. Prompt adjustments shall be made by the parties to reflect
the results of such audit. EpiCept shall bear the full cost of such audit unless such audit
discloses an underpayment by MEDA of more than 5% of the amount of royalty payments due under this
Agreement (or discloses the failure by MEDA to make the payment required by milestone (c) or (d)
pursuant to Section 4.3), in which case, MEDA shall bear the full cost of such audit and shall
promptly remit to EpiCept the amount of any underpayment or non-payment.



5.5 Late Payments. In the event that any payment due under this Agreement is not made when
due, the payment shall accrue interest from the date due at the rate of 5% above the U.S. Prime
Rate (as published in The Wall Street Journal, Eastern Edition); provided, however, that in no
event shall such rate exceed the maximum legal annual interest rate. The payment of such interest
shall not limit EpiCept from exercising any other rights it may have as a consequence of the
lateness of any payment.



6. Intellectual Property.




6.1 Patent Prosecution and Maintenance. EpiCept shall have the first right to file, prosecute
and maintain the EpiCept Patents in the Territory. EpiCept shall keep MEDA reasonably informed as
to the filing, prosecution and maintenance of the EpiCept Patents in the Territory. For purposes
of this Article 6, filing, prosecution and maintenance of the EpiCept Patents shall be deemed to
include, without limitation, filing of applications, the conduct of interferences or oppositions,
and/or requests for reexaminations, reissues or extensions of patent terms (including seeking all
applicable patent term extensions and market exclusivity rights in connection with the Products).
If EpiCept elects to abandon the prosecution and maintenance of any EpiCept Patent in any country
in the Territory, EpiCept shall promptly notify MEDA of such election, but in no case later than 60
days prior to any required action relating to the filing, prosecution or maintenance of such patent
application or patent. In such event, MEDA shall have the right to assume responsibility for the
filing, prosecution and/or maintenance (including seeking all applicable patent term extensions and
market exclusivity rights in connection with the Product) of such EpiCept Patents in such country,
at its own expense, and MEDA shall keep EpiCept reasonably informed on matters regarding such
filing, prosecution and maintenance.



6.2 Cooperation of the Parties. Each party agrees to cooperate fully in the preparation,
filing, prosecution and maintenance of the EpiCept Patents pursuant to Section 6.1 and in the
obtaining and maintenance of any patent extensions, supplementary protection certificates and the
like with respect to EpiCept Patents.


 


15









 





6.3 Infringement by Third Parties. EpiCept and MEDA shall promptly notify the other in
writing of any alleged or threatened infringement of any EpiCept Patent of which they become aware.
EpiCept shall have the sole right to bring and control any action or proceeding with respect to
infringement of any EpiCept Patent outside the Territory at its own expense and by counsel of its
own choice. MEDA shall have the first right to bring and control any action or proceeding with
respect to infringement of any EpiCept Patent within the Territory at its own expense and by
counsel of its own choice, and EpiCept shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice. If MEDA fails to contact the alleged infringing
party or its counsel within 60 days following the notice from EpiCept of alleged infringement or to
bring any such action or proceeding within (a) 180 days following the notice of alleged
infringement or (b) 30 days before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, then EpiCept shall have the
right to bring and control any such action at its own expense and by counsel of its own choice, and
MEDA shall have the right, at its own expense, to be represented in any such action by counsel of
its own choice. In the event a party brings an infringement action in accordance with this
Section 6.3, the other party shall cooperate fully, including, if required to bring such action,
the furnishing of a power of attorney or being named as a party. Neither party shall have the
right to settle any patent infringement litigation under this Section 6.3 relating to any EpiCept
Patent in the Territory without the prior written consent of the other party, which shall not be
unreasonably withheld or delayed. Except as otherwise agreed by the parties in connection with a
cost-sharing arrangement, any recovery realized as a result of litigation regarding alleged
infringement of any EpiCept Patent in the Territory (whether by way of settlement or otherwise),
after reimbursement of any litigation expenses of EpiCept and MEDA, shall be retained by the party
that brought and controlled such litigation for purposes of this Agreement, except that (a) any
recovery realized by MEDA as a result of such litigation, after reimbursement of the parties’
litigation expenses, shall, to the extent attributable to lost sales or lost profits with respect
to Products, be treated as Net Sales for purposes of this Agreement and (b) any recovery realized
by EpiCept as a result of such litigation, after reimbursement of the parties’ litigation expenses,
shall be shared equally with MEDA.



6.4 Infringement of Third Party Rights. Each party shall promptly notify the other in writing
of any allegation by a Third Party that the manufacture, use or sale of any Product infringes or
may infringe the intellectual property rights of such Third Party. EpiCept shall have the sole
right to control any defense of any such claim involving alleged infringement of Third Party rights
by EpiCept’s activities at its own expense and by counsel of its own choice, and MEDA shall have
the right, at its own expense, to be represented in any such action by counsel of its own choice.
MEDA shall have the sole right to control any defense of any such claim involving alleged
infringement of Third Party rights by MEDA’s activities at its own expense and by counsel of its
own choice, and EpiCept shall have the right, at its own expense, to be represented in any such
action by counsel of its own choice. Neither party shall have the right to settle any patent
infringement litigation under this Section 6.4 in a manner that diminishes the rights or interests
of the other party without the written consent of such other party (which shall not be unreasonably
withheld). To the extent MEDA incurs any costs defending any such claim or is required to pay any
damages or payments to settle any such claim, it may offset 50% of all such costs, damages and
payments against all payments payable to EpiCept hereunder up to 50% of the amounts otherwise
payable to EpiCept.


 


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7. Representations and Warranties.




7.1 Mutual Representations and Warranties. Each party represents and warrants to the other
that: (a) it is duly organized and validly existing under the laws of its jurisdiction of
incorporation or formation, and has full corporate or other power and authority to enter into this
Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder, and the person or persons executing this
Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership
action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its
terms, and does not conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction over it.



7.2 EpiCept. EpiCept represents and warrants to, and covenants with, MEDA as of the Effective
Date that:



(a) EpiCept has not granted, and will not grant, to any Third Party or Affiliate any license
or other right under the EpiCept Technology and the Ceplene Trademarks to use, sell, have sold,
offer for sale, import, register, promote, market, and distribute Ceplene or Product in the Field
in the Territory, and EpiCept has not granted, and will not grant, to any Third Party or Affiliate
any license or other right under the EpiCept Patents inconsistent with the rights and licenses
granted to MEDA herein;



(b) EpiCept is the sole owner of all of the outstanding shares of Maxim Pharmaceuticals,
Inc., a Delaware corporation, that owns one or more of the EpiCept Patents and was previously
known as Syntello, Inc.;



(c) the EpiCept Patents and Ceplene Trademarks are existing and have been properly registered
or filed, and properly maintained, under all applicable laws and, to its knowledge, the issued
EpiCept Patents are not invalid or unenforceable;



(d) EpiCept is the sole and exclusive legal, beneficial and record owner of the existing
EpiCept Technology (including the Products) and the Ceplene Trademarks, all of which are free and
clear of any liens, charges, encumbrances and rights of any Third Party, contingent or otherwise;



(e) EpiCept has the full right, power and authority to (i) grant all of the right, title and
interest in the licenses granted to MEDA under this Agreement and (ii) transfer the EpiCept
Know-How in accordance with Section 2.3;



(f) to EpiCept’s knowledge, the exploitation of the EpiCept Technology pursuant to the
License and the Ceplene Trademarks in the Territory does not infringe any Patent owned by an Third
Party;


 


17









 





(g) to EpiCept’s knowledge, there are no pending patent applications of any Third Party that,
if issued, would be infringed by the practice of the EpiCept Technology or the Ceplene Trademarks
or the development and commercialization of the Products in the Territory;



(h) there is no agreement between EpiCept and any Third Party that precludes MEDA from
exploiting the EpiCept Technology or the Ceplene Trademarks in the Territory or requires MEDA to
obtain a sublicense that is necessary to exploit the EpiCept Technology or the Ceplene Trademarks;



(i) there are no claims, judgments, orders or settlements against or owed by EpiCept or any
Affiliates or, to its knowledge, pending or threatened claims, or litigation, in either case
relating to the EpiCept Technology or the Ceplene Trademarks (including any proceedings pending
before any Regulatory Authorities);



(j) EpiCept have not have any knowledge that any Third Party is infringing or
misappropriating any of the EpiCept Technology or Ceplene Trademarks;



(k) no EpiCept Technology is subject to any funding agreement with any government or
governmental agency that would conflict with or preclude the grant to MEDA of the licenses set
forth herein;



(l) except for existing royalty obligations to Dr. Hellstrand, previously disclosed to MEDA,
there are no royalty, commission or similar obligations on EpiCept applicable to the EpiCept
Technology or the Ceplene Trademarks, or any licenses, sublicenses or agreements with Third
Parties relating to or involving the EpiCept Technology or the Ceplene Trademarks;



(m) EpiCept is the lawful holder of all existing Regulatory Approvals (other than Pricing and
Reimbursement Approvals) and regulatory documentation (including EpiCept Product Registration
Data) relating to the Product in the Territory;



(n) The marketing authorization approval (the “MAA”) for the Product in the European Union is
in full force and effect and, to the knowledge of EpiCept, the MAA has been duly and validly
issued; there is no action or proceeding by any Regulatory Authority pending or, to the knowledge
of EpiCept, threatened seeking the revocation or suspension of the MAA;



(o) EpiCept has no knowledge of any facts which furnish any reasonable basis for any
inquiries, notice of adverse findings, warning or other regulatory letters or sanctions, or other
similar communication from Regulatory Authorities; EpiCept has no knowledge of any misstatements
or material omissions relating to the Product in any regulatory submission or other document
required to be maintained by applicable laws and the accuracy of its regulatory submissions has
not been contested by any Regulatory Authority;


 


18









 





(p) there are no inquiries, investigations, actions or other proceedings pending before or,
to the best of EpiCept’s knowledge, threatened by any Regulatory Authority with respect to the
Products or any facility where the Product is manufactured; EpiCept has not received any written
notice relating thereto; and during the Term, EpiCept shall promptly notify MEDA in writing upon
learning of any such actual or threatened investigation, inquiry or proceeding;



(q) EpiCept has disclosed all information in its possession relating to its Post Approval
Commitments to MEDA (including all EpiCept Product Registration Data, material correspondence with
Regulatory Authorities relating to the Products and protocols for Post Approval Commitments and
label extension clinical trials); and



(r) EpiCept has complied with all obligations in respect of the Post-Approval Commitments
and, to EpiCept’s knowledge, there are no additional clinical trials other than the Post Approval
Commitments that EpiCept is required to perform to obtain and maintain Regulatory Approvals of the
Product in the Territory.



7.3 MEDA. During the Term, MEDA represents and warrants that it will not, without the express
prior written consent of EpiCept, directly or indirectly, including, without limitation, whether
through subsidiaries, joint venture partners, as stockholder, supplier, vendor or customer,
develop, use or commercialize any Competing Product in the Territory.



7.4 Disclaimer. Except as expressly set forth in this Agreement, THE EPICEPT TECHNOLOGY AND
INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EPICEPT HEREUNDER ARE PROVIDED “AS IS,” AND EACH PARTY
EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF
DEALING, USAGE OR TRADE PRACTICES, IN CONNECTION WITH CEPLENE OR THE PRODUCTS.



7.5 Limitation of Liability. Except in the case of breach of Article 8, NEITHER PARTY SHALL
BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided, however, that
this Section 7.5 shall not be construed to limit either party’s indemnification obligations under
Article 10.


 


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8. Confidentiality.




8.1 Confidential Information. Except as otherwise provided herein, each party shall maintain
in strict confidence, and shall not use for any purpose or disclose to any Third Party without the
disclosing party’s written consent, information disclosed by the other party in writing and marked
“Confidential” or that is disclosed orally and confirmed in writing as confidential within 30 days
following such disclosure (collectively, “Confidential Information”). Without limiting the
foregoing, Confidential Information shall include information relating to the Product and all
related developments, products, substances, customer lists, pricing policies, employment records
and policies, operational methods, marketing plans and strategies, product development techniques
or plans, methods of manufacture, technical processes, designs and design projects, inventions and
research programs and trade secrets. Confidential Information shall not include any information
that the receiving party can demonstrate by competent evidence: (i) was already known to the
receiving party at the time of disclosure hereunder as evidenced by previously-existing written
records, or (ii) is now or hereafter becomes publicly known other than through acts or omissions of
the receiving party, or (iii) is disclosed to the receiving party on a non-confidential basis by a
Third Party under no obligation of confidentiality to the disclosing party or (iv) is independently
developed by the receiving party without the use of, reliance on or reference to any Confidential
Information disclosed to the receiving party by the disclosing party.



8.2 Permitted Use. Notwithstanding the provisions of Section 8.1 above, each party may
disclose Confidential Information of the other party as expressly permitted by this Agreement, or
if and to the extent such disclosure is reasonably necessary in the following instances:




(a) enforcing such party’s rights under this Agreement;




(b) prosecuting or defending litigation as permitted by this Agreement;




(c) complying with applicable court orders or governmental regulations;



(d) register or record this Agreement or evidence of this Agreement with the applicable
patent authorities;



(e) in the case of MEDA, developing or commercializing the Products in accordance with the
License;



(f) facilitate discussions with actual or potential subcontractors and sublicensees in
connection with the development and commercialization of Products hereunder provided, in each
case, that any such actual or potential subcontractor or sublicensee agrees to be bound by
reasonable obligations of confidentiality and non-use;



(g) respond to any request by any Regulatory Authority in connection with any filings or
applications for Regulatory Approval of the Licensed Product;



(h) comply with requirements to disclose to applicable stock exchanges; provided, that prior
notice of such disclosure shall be provided to the non-disclosing party and reasonable measures,
to the extent available and after consultation with the non-disclosing party, shall be taken to
assure confidential treatment of such information, including requests for redaction of
confidential terms of this Agreement; and



(i) disclosure to Third Parties in connection with due diligence or similar investigations by
such Third Parties, and disclosure to potential Third Party investors, acquirors, merger partners,
or potential providers of equity or debt financing and their advisors in confidential financing
documents, provided, in each case, that any such Third Party agrees to be bound by reasonable
obligations of confidentiality and non-use.


 


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Notwithstanding the foregoing, in the event a party is required to make a disclosure of the other
party’s Confidential Information pursuant to Section 8.2(b) or Section 8.2(c), it will, except
where impracticable, give reasonable advance notice to the other party of such disclosure and use
efforts to secure confidential treatment of such information at least as diligent as such party
would use to protect its own confidential information, but in no event less than reasonable
efforts. In any event, the parties agree to take all reasonable action to avoid disclosure of
Confidential Information hereunder.



8.3 Publications. Each party to this Agreement recognizes that the publication of papers
regarding results of and other information regarding Products, including oral presentations and
abstracts, may be beneficial to both parties provided such publications are subject to reasonable
controls to protect Confidential Information. Accordingly, a party shall have the right to review
and comment on any material proposed for disclosure or publication by the other party, such as by
oral presentation, manuscript or abstract, regarding any Product. Before any such material is
submitted for publication, the party proposing publication shall deliver a complete copy to the
other party at least 45 days prior to submitting the material to a publisher or initiating any
other disclosure. Such other party shall review any such material and give its comments to the
party proposing publication within 30 days of the delivery of such material to such other party.
With respect to oral presentation materials and abstracts, such other party shall make reasonable
efforts to expedite review of such materials and abstracts, and shall return such items as soon as
practicable to the party proposing publication with appropriate comments, if any, but in no event
later than 30 days from the date of delivery to the non-publishing party. The publishing party
shall comply with the other party’s request to delete references to the other party’s Confidential
Information in any such material and agrees to delay any submission for publication or other public
disclosure for a period of up to an additional 60 days for the purpose of allowing the preparation
and filing of appropriate patent applications.



8.4 Publicity. Each of the parties may issue press release, substantially in the form
approved by the other party, announcing the execution of this Agreement promptly following the
Effective Date. In addition, it is understood that each party may desire or be required to issue
subsequent press releases or make disclosures (pursuant to filings with the Securities Exchange
Commission, the Stockholm Stock Exchange or otherwise, as applicable) relating to this Agreement or
activities hereunder. The parties agree to consult with each other reasonably and in good faith
with respect to the text and timing of such press releases or other disclosures prior to the
issuance thereof, provided that a party may not unreasonably withhold or delay consent to such
releases, and that either party may issue such press releases as it determines, based on advice of
counsel, are reasonably necessary to comply with laws or regulations or for appropriate market
disclosure. In addition, following the initial press release announcing this Agreement, either
party shall be free to disclose, without the other party’s prior written consent, the existence of
this Agreement, the identity of the other party and those terms of the Agreement which have already
been publicly disclosed in accordance herewith.


 


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9. Term and Termination.




9.1 Term. The initial term of this Agreement shall commence on the Effective Date and, unless
earlier terminated pursuant to this Article 9, continue until the 10th anniversary of
the Effective Date (the “Initial Term”); provided that, the term of this Agreement will
automatically be extended for successive renewal terms of two years in each country within the
Territory (each, a “Renewal Term”) unless MEDA gives written notice of non-renewal on a country by
country basis at least six months before the expiration of the Initial Term or the then-current
Renewal Term. The Initial Term and any Renewal Term(s) shall collectively constitute the “Term”.



9.2 Termination by Mutual Agreement. The parties shall have the right to terminate this
Agreement at any time upon mutual written agreement.



9.3 Termination by Meda. MEDA shall have the right to terminate this Agreement at any time
upon 6 months prior written notice.



9.4 Termination for Cause. Either EpiCept or MEDA shall have the right to terminate this
Agreement as follows:



(a) If at any time a party shall (i) file in any court or agency pursuant to any statute or
regulation, a petition in bankruptcy or insolvency or for reorganization of the party or its
assets, (ii) propose a written agreement of composition or extension of its debts, (iii) be served
with an involuntary petition against it, filed in any insolvency proceeding, and such petition
shall not be dismissed within 60 days after the filing thereof, (iv) liquidate, dissolve, or
otherwise cease business operations, or (v) make an assignment for the benefit of creditors, the
other party shall have the right to terminate this Agreement by providing written notice thereof.



(b) Either party may terminate this Agreement upon 60 days’ prior written notice if the other
party breaches any of its material duties and obligations under this Agreement, and the breaching
party has not remedied the breach within 60 days after receipt of such notice; provided, however,
that in the case of the breach of any of MEDA’s payment obligations hereunder, then the notice
period for such breach shall be 45 days. In respect of any such uncured breach by MEDA that
arises out of and affects only one or more countries (as opposed to a general, non-country
specific breach of MEDA’s obligations under this Agreement, including but not limited to its
royalty and milestone payment obligations under Article 4), EpiCept’s termination rights under
this Section 9.4(b) shall be limited to termination on a country-by-country basis of MEDA’s rights
to such countries.


 


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9.5 Effects of Termination.



(a) Upon the termination or expiration of this Agreement, (i) all licenses granted under the
terms of this Agreement in respect of the affected countries shall automatically terminate and
revert to EpiCept, (ii) to the extent MEDA then holds assignable Regulatory Approvals in the
affected countries, MEDA shall assign to EpiCept all of MEDA’s rights in respect of such
Regulatory Approvals and (iii) MEDA shall license to EpiCept on a perpetual, exclusive,
royalty-free basis the right to use the MEDA Improvements and the Joint Improvements to develop
and commercialize Products in the affected countries.



(b) In the event this Agreement is terminated in any country for any reason after the
Regulatory Approval of the Product in the Territory, MEDA and its Affiliates shall have the right
to sell or otherwise dispose in such country Products then held in inventory by MEDA and its
Affiliates, all subject to the payment to EpiCept of all amounts due pursuant to Article 4 hereof.



(c) Within 30 days following the expiration or termination of this Agreement in all countries
for any reason (except termination for cause by MEDA under Section 9.4), and except as set forth
in Section 9.5(b), EpiCept shall promptly return to MEDA all Confidential Information of MEDA
provided to EpiCept hereunder, and MEDA shall: (i) return to EpiCept all Confidential Information
of EpiCept and all EpiCept Technology provided by EpiCept to MEDA hereunder and that is in MEDA’s
or its Affiliates’ possession, including any and all documentation and other tangible embodiments
thereof, except that MEDA may retain one archival copy of the EpiCept’s Confidential Information
solely for purposes of monitoring compliance with its surviving obligations hereunder and
complying with applicable law; (ii) transfer to EpiCept all data and information generated under
this Agreement and in the possession of MEDA or its Affiliates relating to Ceplene or Products (to
the extent not previously disclosed to EpiCept); (iii) transfer and assign to EpiCept all of its
right, title and interest in and to all Pricing and Reimbursement Approvals (including
applications therefor) to the extent permitted by applicable laws; (iv) license to EpiCept on a
perpetual, exclusive, royalty-free basis the right to use the MEDA Improvements and the Joint
Improvements to develop and commercialize Products in the Territory and (v) take such other
actions and execute such other instruments, assignments and documents as may be necessary to
effect the transfer of rights to EpiCept under this the preceding clauses (iii) and (iv).



(d) Without limiting MEDA’s rights under Section 9.4, MEDA may elect, in lieu of termination
of the Agreement, to continue to exploit Products in the Territory pursuant to the License;
provided, that MEDA provides EpiCept with 60 days written notice specifying the material breach and
stating its intent to continue to exploit the Products. If EpiCept fails to cure such breach
during such notice period, (i) all amounts otherwise payable thereafter by Meda shall be reduced
by 50%; (ii) the JCC shall be dissolved; (iii) EpiCept shall transfer to MEDA all of its right,
title and interest in and to all Regulatory Approvals, drug dossiers and master files with respect
to Ceplene or any Product in the Territory, including any and all documentation relating thereto to
the extent permitted by applicable laws; and (iv) take such other actions and execute such other
instruments, assignments and documents as may be necessary to effect the transfer of rights to MEDA
under the preceding clause (iii).



(e) Neither termination nor expiration of this Agreement shall relieve the parties of any
obligation accruing prior to such expiration or termination, including any such payment obligation
under Article 4. Without limiting the foregoing and in addition to any provisions specified in
this Agreement as surviving under the applicable circumstances, the obligations and rights of the
parties under Sections 2.4(c), 6.4, 7.4, 7.5 and 9.5 and Articles  5, 8, 10, 11 and 12 (and, to
the extent required to give effect to the foregoing, Article 1) shall survive termination or
expiration of this Agreement.


 


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(f) All rights and licenses granted under or pursuant to this Agreement by EpiCept are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. MEDA, as licensee of such rights under this Agreement, shall retain and may fully exercise
all of its rights and elections under the U.S. Bankruptcy Code. In the event of the commencement
of a bankruptcy proceeding by or against EpiCept under the U.S. Bankruptcy Code, MEDA shall be
entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual
property and all embodiments of such intellectual property, which, if not already in its
possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy
proceeding upon MEDA’s written request therefor, unless EpiCept elects to continue to perform all
of its obligations under this Agreement or (b) if not delivered under (a) above, following the
rejection of this Agreement by or on behalf of EpiCept upon written request therefor by MEDA.



10. Indemnification.




10.1 MEDA. MEDA shall defend and indemnify EpiCept and its Affiliates and their respective
directors, officers, employees and agents (each, an “EpiCept Indemnitee”) against any and all
claims, suits, actions, demands, liabilities, expenses and/or loss, including reasonable legal
expense and attorneys’ fees, (collectively, “Losses”) to which any EpiCept Indemnitee becomes
subject as a result of any claim, demand, action or other proceeding by any Third Party to the
extent such Losses arise directly or indirectly out of:




(i) except to the extent provided in Section 10.2(iii), the development, use, handling,
storage, sale or other disposition of Ceplene or Product by MEDA or any of its Affiliates or
distributors,




(ii) the breach by MEDA of any warranty, representation, covenant or agreement made by
MEDA in this Agreement,




(iii) the gross negligence or willful misconduct of any MEDA Indemnitee (defined
below); except, in each case, to the extent such Losses result from the gross negligence or
willful misconduct of any EpiCept Indemnitee or the breach by EpiCept of any warranty,
representation, covenant or agreement made by EpiCept in this Agreement, or




(iv) all other claims arising out of the failure by MEDA to comply with any legal or
other requirements in respect of the Regulatory Approvals in those countries in the
Territory for which it is the MAH (including any failure to warn) or of the Pricing and
Reimbursement Approvals.


 


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10.2 EpiCept. EpiCept shall defend and indemnify MEDA and its Affiliates and distributors
and their respective directors, officers, employees and agents (each, a “MEDA Indemnitee”) against
any and all Losses to which any MEDA Indemnitee becomes subject as a result of any claim, demand,
action or other proceeding by any Third Party to the extent such Losses arise directly or
indirectly out of:




(i) the breach by EpiCept of any warranty, representation, covenant or agreement made
by EpiCept in this Agreement,




(ii) the development, use, manufacture, commercialization, handling, storage, supply or
other disposition of Products outside the Territory;




(iii) the manufacture of the Product by or for EpiCept and its Affiliates, acts or
omissions of EpiCept or its contractors in the development of the Product or the failure by
EpiCept to comply with any legal or other requirements in respect of the Regulatory
Approvals for which it is the MAH (including the failure to warn),




(iv) the IDIS Arrangement, including all payments and other obligations to IDIS Ltd.
and all claims arising out of the use of the Products distributed under the IDIS
Arrangement; or




(v) gross negligence or willful misconduct of any EpiCept Indemnitee; except, in each
case, to the extent such Losses result from the gross negligence or willful misconduct of
any MEDA Indemnitee or the breach by MEDA of any warranty, representation, covenant or
agreement made by MEDA in this Agreement.



10.3 Procedure. In the event a party (the “Indemnified Party”) seeks indemnification under
Section 10.1 or 10.2, as applicable, it shall inform the other party (the “Indemnifying Party”) of
a claim as soon as reasonably practicable after it receives notice of the claim (it being
understood and agreed, however, that the failure by an Indemnified Party to give notice of a claim
as provided in this Section 10.3 shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that such Indemnifying Party is
actually damaged as a result of such failure to give notice), shall permit the Indemnifying Party
to assume direction and control of the defense of the claim (including the right to settle the
claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnified
Party, and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense
of the claim. If the Indemnifying Party does not assume control of such defense within 15 days
after receiving notice of the claim from the Indemnified Party, the Indemnified Party shall control
such defense and, without limiting the Indemnifying Party’s indemnification obligations, the
Indemnifying Party shall reimburse the Indemnified Party for all reasonable costs, including
reasonable attorney fees, incurred by the Indemnified Party in defending itself within 30 days
after receipt of any invoice therefore from the Indemnified Party. The party not controlling such
defense may participate therein at its own expense. The party controlling such defense shall keep
the other party advised of the status of such action, suit, proceeding or claim and the defense
thereof and shall consider recommendations made by the other party with respect thereto. The
Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim
without the prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to any settlement of such
action, suit, proceeding or claim or consent to any judgment in respect thereof that does not
include a complete and unconditional release of the Indemnified Party from all liability with
respect thereto, that imposes any liability or obligation on the Indemnified Party or that
acknowledges fault by the Indemnified Party, in each case without the prior written consent of the
Indemnified Party.


 


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10.4 Insurance. During the Term and for a period of three years after the expiration or
termination of this Agreement, each party shall maintain comprehensive general liability insurance,
including, without limitation, product liability and completed operations liability insurance, in
amounts that are commercially reasonable in light of such party’s activities under this Agreement
and sufficient to cover such party’s obligations hereunder. It is understood that such insurance
shall not be construed to limit either party’s indemnification obligations under this Article 10.
Such insurance shall be placed with a reputable insurance carrier. At a party’s reasonable
request, the other party shall furnish a certificate of insurance to the requesting party
evidencing the foregoing insurance coverage.



11. Dispute Resolution.




11.1 Dispute Resolution. Any dispute arising under or relating to the parties rights and
obligations under this Agreement will be referred to the Chief Executive Officer of EpiCept and the
[Chief Operating Officer] of MEDA for resolution (the “Authorized Officers”). Each Authorized
Officer shall appoint two additional authorized representatives of such party to serve as a member
of a Dispute Resolution Committee (the “DRC”). In the event of a dispute, the DRC shall meet and
attempt, in good faith, to resolve such dispute. If the DRC is unable to resolve such dispute
within 30 days of such dispute being referred to them, then, upon the written request of either
party to the other party, the dispute shall be subject to arbitration, as provided in Section 11.2.




11.2 Arbitration.



(a) Claims. Any claim, dispute, or controversy of whatever nature arising out of or relating
to this Agreement that is not resolved pursuant to Section 11.1 within the required 30-day period,
including without limitation, any action or claim based on tort, contract, or statute, or
concerning the interpretation, effect, termination, validity, performance and/or breach of this
Agreement (“Claim”), shall be resolved by final and binding arbitration before a panel of three
neutral experts with relevant industry experience. The arbitration proceeding shall be
administered by the American Arbitration Association (the “AAA”) in accordance with its then
existing International Arbitration Rules, and the panel of arbitrators shall be selected in
accordance with such rules. The arbitration shall be conducted in English, and shall be held in
New York, New York, USA.



(b) Arbitrators’ Award. The arbitrators shall, within 15 days after the conclusion of the
arbitration hearing, issue a written award and statement of decision describing the essential
findings and conclusions on which the award is based, including the calculation of any damages
awarded. The decision or award rendered by the arbitrators shall be final and non-appealable, and
judgment may be entered upon it in any court of competent jurisdiction. The arbitrators shall be
authorized to award compensatory damages, but shall NOT be authorized (i) to award non-economic
damages, (ii) to award punitive damages, or (iii) to reform, modify or materially change this
Agreement or any other agreements contemplated hereunder; provided, however, that the damage
limitations described in parts (i) and (ii) of this sentence will not apply if such damages are
statutorily imposed.


 


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(c) Costs. Each party shall bear its own attorneys’ fees, costs, and disbursements arising
out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators;
provided, however, the arbitrators shall be authorized to determine whether a party is the
prevailing party, and at their discretion, to award to that prevailing party reimbursement for its
reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees
and expenses, photocopy charges and travel expenses), and/or the reasonable fees and costs of the
AAA and the arbitrators.



11.3 Court Actions. Nothing contained in this Agreement shall deny either party the right to
seek injunctive or other equitable relief from a court of competent jurisdiction in the context of
a bona fide emergency or prospective irreparable harm, including without limitation relating to the
violation of the confidentiality provisions of Article 8 hereof, and such an action may be filed
and maintained notwithstanding any ongoing arbitration proceeding. In addition, either party may
bring an action in any court of competent jurisdiction to resolve disputes pertaining to the
validity, construction, scope, enforceability, infringement or other violations of Patents or other
intellectual property rights, and no such matter shall be subject to arbitration pursuant to
Section 11.2.



11.4 Continued Performance. The parties agree to continue performing under the Agreement in
accordance with its provisions, pending the final resolution of any dispute, and without limiting
the foregoing, shall continue to cooperate and participate in the JCC and the DRC as provided for
in this Agreement.



12. Miscellaneous. 




12.1 Governing Law. This Agreement and any disputes, claims, or actions related thereto shall
be governed by and construed in accordance with the laws of the State of New York, USA, without
regard to the conflicts of laws provisions thereof with the exceptions. of Sections 5-1401 and
5-1402 of the New York General Obligations Law.



12.2 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, is both a
final expression of the parties’ agreement and a complete and exclusive statement with respect to
all of its terms. This Agreement and the Supply Agreement supersede all prior and contemporaneous
agreements and communications, whether oral, written or otherwise, concerning any and all matters
contained herein. This Agreement may only be modified or supplemented in a writing expressly
stated for such purpose and signed by the parties to this Agreement.



12.3 Relationship Between the Parties. The parties’ relationship, as established by this
Agreement, is solely that of independent contractors. This Agreement does not create any
partnership, joint venture or similar business relationship between the parties. Neither party is
a legal representative of the other party, and neither party can assume or create any obligation,
representation, warranty or guarantee, express or implied, on behalf of the other party for any
purpose whatsoever.


 


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12.4 Non-Waiver. The failure of a party to insist upon strict performance of any provision of
this Agreement or to exercise any right arising out of this Agreement shall neither impair that
provision or right nor constitute a waiver of that provision or right, in whole or in part, in that
instance or in any other instance. Any waiver by a party of a particular provision or right shall
be in writing, shall be as to a particular matter and, if applicable, for a particular period of
time and shall be signed by such party.



12.5 Assignment. Except as expressly provided hereunder, neither this Agreement nor any
rights or obligations hereunder may be assigned or otherwise transferred by either party without
the prior written consent of the other party (which consent shall not be unreasonably withheld; it
being agreed that it shall not be deemed unreasonable for a party to withhold consent to an
assignment if a transferee fails to demonstrate to such party’s reasonable satisfaction that it has
similar or greater financial wherewithal and experience as the transferring party in order to be
able to fulfill the obligations of the party seeking to transfer its rights under this Agreement);
provided, however, that either party may assign this Agreement and its rights and obligations
hereunder without the other party’s consent (a) to an Affiliate, provided that the assigning party
shall remain liable and responsible to the non-assigning party hereto for the performance and
observance of all such duties and obligations by such Affiliate or (b) to a Third Party purchaser
of all or substantially all of the assigning party’s assets. The rights and obligations of the
parties under this Agreement shall be binding upon and inure to the benefit of the successors and
permitted assigns of the parties, and the name of a party appearing herein will be deemed to
include the name of such party’s successors and permitted assigns to the extent necessary to carry
out the intent of this section. Any assignment not in accordance with this Agreement shall be
void.



12.6 No Third Party Beneficiaries. This Agreement is neither expressly nor impliedly made for
the benefit of any party other than those executing it and their permitted successors and assigns.



12.7 Severability. If, for any reason, any part of this Agreement is adjudicated invalid,
unenforceable or illegal by a court of competent jurisdiction, such adjudication shall not affect
or impair, in whole or in part, the validity, enforceability or legality of any remaining portions
of this Agreement. All remaining portions shall remain in full force and effect as if the original
Agreement had been executed without the invalidated, unenforceable or illegal part.


 


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12.8 Notices. Any notice to be given under this Agreement must be in writing and delivered
either in person, by any method of mail (postage prepaid) requiring return receipt, or by overnight
courier or facsimile confirmed thereafter by any of the foregoing, to the party to be notified at
its address(es) given below, or at any address such party has previously designated by prior
written notice to the other. Notice shall be deemed sufficiently given for all purposes upon the
earliest of: (a) the date of actual receipt; (b) if mailed, five days after the date of postmark;
or (c) if delivered by express courier, the next business day the courier regularly makes
deliveries in the country of the recipient.



	 	 	 
	If to MEDA:

	 	MEDA AB
	 

	 	Box 906
	 

	 	SE-170 09
	 

	 	Solna, Sweden
	 

	 	Attention: Anders Lönner, CEO
	 

	 	Telephone: +46 630 19 00
	 

	 	Facsimile: +46 8 630 19 19
	 
	 	 
	If to EpiCept:

	 	EpiCept Corporation
	 

	 	777 Old Saw Mill Road
	 

	 	Tarrytown, NY  10591
	 

	 	USA
	 

	 	Attention: Jack Talley
	 

	 	Telephone: +1-914-606-3500
	 

	 	Facsimile: +1-914-606-3501






12.9 Force Majeure. Each party shall be excused from liability for the failure or delay in
performance of any obligation under this Agreement by reason of any event beyond such party’s
reasonable control including but not limited to Acts of God, fire, flood, explosion, earthquake, or
other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other
casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw
materials, any strike or labor disturbance, or any other event similar to those enumerated above.
Such excuse from liability shall be effective only to the extent and duration of the event(s)
causing the failure or delay in performance and provided that the party has not caused such
event(s) to occur. Notice of a party’s failure or delay in performance due to force majeure must
be given to the other party within 10 days after its occurrence or as soon as reasonably practical
thereafter. All delivery and payment dates under this Agreement that have been affected by force
majeure shall be tolled for the duration of such force majeure. The party seeking relief under
this Section 12.9 shall use reasonable efforts to prevent and mitigate the effect of any such force
majeure event; provided, that in no event shall any party be required to prevent or settle any
labor disturbance or dispute.


 


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12.10 Interpretation. The headings of clauses contained in this Agreement preceding the text
of the sections, subsections and paragraphs hereof are inserted solely for convenience and ease of
reference only and shall not constitute any part of this Agreement, or have any effect on its
interpretation or construction. All references in this Agreement to the singular shall include the
plural where applicable, and all references to gender shall include both genders and the neuter.
Unless otherwise specified, references in this Agreement to any Article, Section, subsection or
subparagraph shall include all Sections, subsections and subparagraphs of any such Article or all
subsections and subparagraphs of any such Section, subsection or subparagraph, as applicable. All
references to days in this Agreement shall mean calendar days, unless otherwise specified.
Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall
be deemed to mean “including without limitation” and “including but not limited to.” The word “or”
shall be construed to have the same meaning and effect as “and/or”. Unless the context requires
otherwise, (a) any definition of or reference to any agreement, instrument or other document herein
shall be construed as referring to such agreement, instrument or other document as from time to
time amended, supplemented or otherwise modified (subject to any restrictions on such amendments,
supplements or modifications set forth herein or therein). Any reference to any laws herein shall
be construed as referring to any law, statute, rule, regulation, ordinance or other pronouncement
having the effect of law of any federal, national, multinational, state, provincial, county, city
or other political subdivision, domestic or foreign, as they from time to time may be enacted,
repealed or amended. The words “herein”, “hereof”, “hereunder” and words of similar import shall
be construed to refer to this Agreement in its entirety and not to any particular provision of this
Agreement. Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted
against either party, irrespective of which party may be deemed to have caused the ambiguity or
uncertainty to exist. This Agreement has been prepared in the English language and the English
language shall control its interpretation. In addition, all notices required or permitted to be
given hereunder, and all written, electronic, oral or other communications between the parties
regarding this Agreement shall be in the English language.



12.11 Further Assurances. Each party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.



12.12 Counterparts. This Agreement may be executed in counterparts, including by transmission
of facsimile or PDF copies of signature pages to the parties or their representative legal counsel,
each of which shall be deemed an original document, and all of which, together with this writing,
shall be deemed one instrument.



[Remainder of this page intentionally left blank.]




 


30









 







In Witness Whereof, the parties hereto have duly executed this License and
Supply Agreement as of the Effective Date.



	 	 	 	 	 	 	 	 	 
	EpiCept Corporation	 	 	 	MEDA AB
	 
	 	 	 	 	 	 	 	 
	By:

	 	 	 	 	 	By:	 	 
	 

	 	 
	 	 	 	 	 	 
	 

	 	Name: Jack Talley
	 	 	 	 	 	Name: Anders Lönner
	 

	 	Title: President and CEO
	 	 	 	 	 	Title: CEO
	 
	 	 	 	 	 	 	 	 
	EpiCept GmbH	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	By:
	 	 	 	 	 	 	 	 
	 

	 	 

Name: Jack Talley
	 	 	 	 	 	 
	 

	 	Title: CEO	 	 	 	 	 	 






 


 









 





Exhibit A

EpiCept Patents




I.  Europe




	 	 	 	 	 	 	 	 	 
	Description	 	Number	 	Country	 	Filing Date	 	Issued Date
	 
	Anti-tumor
Preparation
Comprising
Interleukin-2 and
Histamine Analogs
Thereof or
H2-Receptor
Agonists

	 	EP493,468
	 	Austria, Belgium,
Switzerland,
Germany, Denmark,
Spain, France,
Great Britain,
Italy, Luxemburg,
Netherlands,
Norway, Sweden
	 	9/19/90
	 	4/17/96
	 
	 	 	 	 	 	 	 	 
	Synthesis of
Histamine
Dihydrochloride

	 	EP1140857
	 	Austria, Belgium,
Cyprus, Denmark,
Finland, France,
Germany, Greece,
Ireland, Italy,
Luxembourg, Monaco,
Netherlands,
Portugal, Spain,
Sweden,
Switzerland, UK
	 	12/20/99
	 	7/2/08
	 
	 	 	 	 	 	 	 	 
	Use of histamine
dichloride for the
treatment of AML

	 	EP921811
	 	Austria, Belgium,
Switzerland,
Germany, Denmark,
Spain, Finland,
France, UK, Greece,
Ireland, Italy,
Lichtenstein,
Luxembourg, Monaco,
Netherlands,
Portugal, Sweden
	 	[to be provided by
EpiCept]
	 	[to be provided by

EpiCept]





 


1









 





II. Other Countries




	 	 	 	 	 	 	 	 	 	 	 
	Description	 	Number	 	Country	 	Filing Date	 	Issued Date
	 
	Anti-tumor
Preparation
Comprising
Interleukin-2 and
Histamine Analogs
Thereof or
H2-Receptor
Agonists

	 	 	640954	 	 	Australia
	 	9/19/90
	 	1/25/94
	“

	 	 	2845622	 	 	Japan
	 	9/19/90
	 	10/30/98
	“

	 	 	195392	 	 	Korea
	 	3/19/92
	 	2/11/99
	Synthesis of
Histamine
Dihydrochloride

	 	ZL9981490.3
	 	China
	 	12/20/99
	 	6/30/04
	“

	 	 	4139082	 	 	Japan
	 	12/20/99
	 	6/13/08
	“

	 	 	I243166	 	 	Taiwan
	 	12/23/99
	 	11/11/05
	“

	 	 	205849	 	 	India
	 	12/20/99
	 	6/13/07
	“

	 	 	763523	 	 	Australia
	 	12/20/99
	 	11/06/03
	“

	 	 	512935	 	 	New Zealand
	 	12/20/99
	 	6/13/98
	Use of histamine dichloride for the
treatment of AML	 	[to be provided by EpiCept]






 


2









 





Exhibit B



EpiCept’s Post Approval Commitments








EXHIBIT 2 — CONFIDENTIAL July 24, 2008




***




 


3









 









***




 


4









 







Exhibit C


Territory









	 	 	 
	Europe
	 	
	Albania
	 	Liechtenstein
	Andorra
	 	Lithuania
	Austria
	 	Luxembourg
	Belarus
	 	Malta
	Belgium
	 	Moldova
	Bosnia-Herzegovina
	 	Monaco
	Bulgaria
	 	Montenegro
	Croatia
	 	Norway
	Cyprus
	 	Poland
	Czech Republic
	 	Portugal
	Denmark
	 	Romania
	Estonia
	 	Russia
	Finland
	 	San Marino
	Former
Yugoslav Republic of Macedonia
	 	Serbia

 Slovakia
	France
	 	Slovenia
	Germany
	 	Spain
	Greece
	 	Sweden
	Hungary
	 	Switzerland
	Iceland
	 	The Netherlands
	Ireland
	 	The United Kingdom
	Italy
	 	Turkey
	Latvia
	 	Ukraine

Vatican City







	 	 	 
	Other Countries
	 	 
	Australia
	 	Japan
	Georgia
	 	Kuwait
	Hong Kong
	 	Malaysia
	India
	 	New Zealand
	Indonesia
	 	Oman
	People’s Republic of China
	 	Pakistan
	Philippines
	 	 
	Qater
	 	 
	Republic of China (Taiwan)
	 	 
	Saudi Arabia
	 	 
	Singapore
	 	 
	South Korea
	 	 
	Thailand
	 	 
	United Arab Emirates
	 	 





 


5









 





Exhibit D




CEPLENE TRADEMARKS




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Renewal	 
	Mark	 	Country	 	 	Status	 	Class	 	 	Applic No	 	 	File Date	 	Reg No	 	Reg Date	 	Date
	CEPLENE
	 	AU	 	Registered	 	 	5	 	 	 	858297	 	 	23-Nov-00	 	 	858297	 	 	17-May-01	 	23-Nov-10
	CEPLENE
	 	CH	 	Registered	 	 	5	 	 	 	13973/2000	 	 	23-Nov-00	 	 	483420	 	 	04-Apr-01	 	23-Nov-10
	CEPLENE
	 	CN	 	Registered	 	 	5	 	 	 	2001045526	 	 	28-Mar-01	 	 	1760656	 	 	07-May-02	 	06-May-12
	CEPLENE
	 	EU	 	Registered	 	 	5	 	 	 	1965656	 	 	22-Nov-00	 	 	1965656	 	 	22-May-02	 	22-Nov-10
	CEPLENE
	 	IL	 	Renewed	 	 	5	 	 	 	144206	 	 	26-Nov-00	 	 	144206	 	 	05-Feb-02	 	26-Nov-21
	CEPLENE
	 	JP	 	Registered	 	 	5	 	 	 	21001-029763	 	 	30-Mar-01	 	 	4671668	 	 	16-May-03	 	16-May-13
	CEPLENE
	 	LI	 	Registered	 	 	5	 	 	 	13015	 	 	08-Oct-03	 	 	13015	 	 	13-Jan-04	 	08-Oct-13
	CEPLENE
	 	NO	 	Registered	 	 	5	 	 	 	2003309400	 	 	07-Oct-03	 	 	224104	 	 	01-Sep-04	 	01-Sep-14
	CEPLENE
	 	NZ	 	Renewed	 	 	5	 	 	 	627694	 	 	29-Sep-00	 	 	627694	 	 	24-May-01	 	29-Sep-17





 


6









 





Exhibit E




Expanded Indication Studies




EPC2008-02— An Open-Label, Multicenter Study of the Effects of Remission Maintenance Therapy with
Ceplene® (Histamine Dihydrochloride), Given in Conjunction with Low Dose Interleukin-2 (IL-2,
ProleukinÒ), on Immune Response and Minimal Residual Disease (MRD) in Adult Patients with Acute
Myeloid Leukemia (AML) in First Complete Remission (CR1)



A Phase I/II study on combination of immunomodulatory (histamine and low-dose interleukin-2) and
tyrosine kinase inhibitor therapy for eradication of minimal residual disease in adult patients
with chronic myeloid leukemia


 


7









 





Exhibit F




SUPPLY TERMS




for




PRODUCT SUPPLY




	 	 	 
	Finished Product

	 	0.5mg/0.5ml Ceplene in a sealed 2ml vial,
labeled, packaged and released according
to the specifications approved by the
parties, rules and regulations in the
different countries in the Territory.
	 
	 	 
	Finished Product Supply

	 	EpiCept will supply such quantities of
Finished Product as may be ordered by Meda
for sale in the Territory. The Finished
Product delivered by EpiCept shall be
fully compliant, packaged, labelled and
released. MEDA shall import the Product
exclusively from EpiCept and EpiCept shall
supply all requirements for Product to
MEDA for sale in the Territory.
	 
	 	 
	Subcontractors

	 	EpiCept may use Third Party contract
manufacturers so long as such
manufacturers are otherwise competent and
reliable and such manufacturers and their
facilities comply with all cGMP
requirements and are approved by the
applicable Regulatory Authorities to
manufacture the Finished Product.
	 
	 	 
	Failure to Supply

	 	EpiCept will maintain sufficient
manufacturing capacity to meet the
worldwide forecasted demand for such the
Products. If EpiCept becomes unable to
supply the worldwide quantities of
Finished Products ordered or forecasted by
Meda and EpiCept, then available Finished
Product shall be allocated to the parties
in proportion to then outstanding orders
and forecasts.
	 
	 	 
	Purchase Price

	 	The purchase price (the “Purchase Price”)
for the Finished Product will be an amount
equal to *** per vial. Commencing ***,
the Purchase Price shall be subject to an
annual adjustment to reflect changes in
the costs of labor and raw materials.
Except to the extent attributable to
changes in the quantities forecasted by
Meda, the Purchase Price shall not be so
adjusted in any year by more than the
percentage changes in an applicable
producer price index.






 


8









 





	 	 	 
	Payments

	 	EpiCept will submit invoices upon each
shipment. Meda will pay all invoices,
plus all proper taxes, freight and other
transportation charges stated thereon,
within 45 days after its receipt.
	 
	 	 
	Forecasts

	 	Prior to the first day of each month (M1),
Meda shall provide rolling forecasts of
its requirements of the Finished Product
for the *** following the second month
after the date of each forecast (M3-M26).
The *** of each forecast (M3-M5) shall be
binding orders and shall specify the
monthly quantity of Finished Product.
Meda must later submit binding orders for
*** of the quantity forecasted for months
M6-M8. EpiCept shall not be obligated to
supply *** of the quantities forecasted
for months M6-M8. The Parties shall
mutually agree upon supply quantities and
delivery times for the initial orders
during *** after launch of the Product.
EpiCept shall maintain an adequate
inventory of Finished Product to ensure a
safety stock of ***.
	 
	 	 
	Delivery

	 	All Finished Products will be delivered Ex
Works (INCOTERMS 2000) at the place of
manufacture in Bolton, England. Finished
Product shall be delivered with a
remaining shelf life of ***. Except to the
extent attributable to causes beyond the
control of EpiCept and its subcontractors,
the Purchase Price for Finished Product
that is delivered more than a week later
than its scheduled delivery date shall be
reduced by ***.
	 
	 	 
	Quality

	 	EpiCept shall be responsible for
manufacturing the Finished Product
according to all applicable laws, cGMP
guidelines and rules, the approved
specifications and the requirements of the
marketing authorization for the Product.
The Finished Product will be released in
accordance with all applicable regulatory
requirements and mutually acceptable
release specifications. A Certificate of
Analysis will accompany each batch of
Finished Product. If Meda provides prompt
written notice that any Finished Product
does not conform to any such requirements,
EpiCept will, at Meda’s option, replace
the non-conforming Finished Product or
refund the applicable Finished Product
Purchase Price. An independent testing
laboratory will resolve all disputes
regarding the quality of the Finished
Product.






 


9









 





	 	 	 
	Recalls

	 	If the Finished Product should be
recalled, the parties will take all
appropriate corrective actions. *** will
be responsible for all recall costs to the
extent resulting from a breach of the
foregoing quality requirements and this
Agreement or the Supply Agreement. The
parties will fully cooperate and provide
all reasonable assistance in conducting
any recall.
	 
	 	 
	Inspections Rights; Records

	 	EpiCept shall grant to Meda’s quality
assurance and quality control personnel,
upon reasonable notice, access to its and
its subcontractors facilities and related
documentation for the purpose of routine
GMP audits. EpiCept shall (a) participate
and cooperate with such Meda
representatives, and (b) take corrective
action in a timely manner as may be
reasonably required to comply with cGMP
requirements. Upon reasonable prior
notice, EpiCept shall permit Meda to
review periodically EpiCept’s quality
control procedures and records to assure
satisfaction of the appropriate quality
requirements. If any of the facilities in
which the Finished Product is manufactured
are the subject of an inspection by any
Regulatory Authority, EpiCept shall notify
Meda, allow Meda to participate in such
inspection and shall provide Meda a
summary of any deficiencies identified by
such Regulatory Authority. 




EpiCept shall maintain reference samples,
all batch and other manufacturing and
analytical records, all records of
shipments of the Finished Products and all
validation data relating to the Finished
Products for the time periods required by
applicable laws and shall make such data
available to Meda upon its reasonable
request.
	 
	 	 
	Labels

	 	All Finished Products will be shipped in
final package form with all applicable
packaging labels, including all package
inserts.
	 
	 	 
	Term

	 	TBD, but not longer than the Term
	 
	 	 
	Backup Supply

	 	TBD: the parties shall discuss and include
in the Supply Agreement provisions
granting Meda the right to qualify
alternative suppliers to satisfy any
demand for the Finished Product that is
not supplied by EpiCept in a timely manner
in circumstances where EpiCept has
repeatedly failed to assure adequate or
timely supply after reasonable
opportunities to cure; such provisions
shall include appropriate transfer and
license of manufacturing and quality
control know how







 


10