Exhibit
10.2


 


Development
and


Commercialization
Agreement


 


between


 


ImmuPharma
(France) S.A.


as “ImmuPharma”


 


and


 


Anesta
AG


as “Anesta”


 


relating to


 


Lupuzor


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


1

















 


THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
(this “Agreement” is made as of the Effective Date as defined hereinafter and
is made


 


BETWEEN:


 


(1)           ImmuPharma (France) S.A.,  (“ImmuPharma”),
incorporated in France and having its registered office at 5, rue du Rhône,
F-68100 Mulhouse, France; and


 


(2)           Anesta AG  (“Anesta”),
incorporated in Switzerland and having its
registered office at Barrenstrasse 23, 6300 Zug, Switzerland and an Affiliate
(defined herein) of Cephalon, Inc., incorporated in Delaware, U.S.A.
(“Cephalon”). 


 


(each of ImmuPharma and
Anesta are hereinafter referred to as “Party” and together referred to
as “Parties)


 


WHEREAS:


 


(A)          ImmuPharma owns
or Controls certain proprietary rights, titles and interest in certain Patents
and certain valuable Technical Information relating to its Lupuzor product
pursuant to certain agreements with CNRS (all as hereinafter defined);


 


(B)           ImmuPharma
conducted various pre-clinical and clinical studies with the Lupuzor product
and it appears that the Lupuzor product may be capable of being further developed
and commercialised as a treatment for Lupus;


 


(C)           Anesta wishes to
develop and commercialise ImmuPharma’s Lupuzor product in the Territory (as
hereinafter defined) for Lupus and any other indications for which the Lupuzor
product may be developed, marketed or used on the terms and conditions hereof,
however subject to ImmuPharma’s obtaining certain positive results in the
clinical trial currently being conducted on behalf of ImmuPharma for the
Lupuzor product;


 


(D)          Anesta and
ImmuPharma AG have furthermore agreed to simultaneously herewith enter into the
Trademark License Agreement (as hereinafter defined);  


 


NOW
THEREFORE, in
consideration of the mutual promises and covenants set forth and for good and
valuable consideration, the sufficiency of which is hereby acknowledged, and
intending to be legally bound hereby, the Parties hereby agree as follows:


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


2

















 


TABLE
OF CONTENTS:


 


	
  1.

  	
  Definitions

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.2

  	
  Sections and Clauses

  	
  13

  
	
   

  	
   

  	
   

  
	
  2.

  	
  Payment of the Decision Payment and Effective Date
  of Agreement

  	
  14

  
	
   

  	
   

  	
   

  
	
  3.

  	
  Grant

  	
  14

  
	
   

  	
   

  	
   

  
	
  4.

  	
  Development Milestone Payments

  	
  16

  
	
   

  	
   

  	
   

  
	
  5.

  	
  Commercial Milestone Payments

  	
  16

  
	
   

  	
   

  	
   

  
	
  6.

  	
  Running Royalties

  	
  17

  
	
   

  	
   

  	
   

  
	
  7.

  	
  Timing and Statement of Royalty and Milestone
  Payments

  	
  17

  
	
   

  	
   

  	
   

  
	
  8.

  	
  Accounting and Other Financial Provisions Relating
  to Royalties and Other Payments

  	
  18

  
	
   

  	
   

  	
   

  
	
  9.

  	
  Remittance, Currency and Taxes

  	
  18

  
	
   

  	
   

  	
   

  
	
  10.

  	
  Audit of Financial Milestones, Royalties, Cost of
  Goods etc.

  	
  19

  
	
   

  	
   

  	
   

  
	
  11.

  	
  Development of Licensed Product

  	
  20

  
	
   

  	
   

  	
   

  
	
  12.

  	
  Production and Supply of Materials for the
  Development Program

  	
  21

  
	
   

  	
   

  	
   

  
	
  13.

  	
  Manufacturing Development

  	
  21

  
	
   

  	
   

  	
   

  
	
  14.

  	
  Manufacture of Licensed Products by Anesta;
  Manufacture by ImmuPharma

  	
  22

  
	
   

  	
   

  	
   

  
	
  15.

  	
  Obtaining and Maintaining NDAs for Licensed Product

  	
  22

  
	
   

  	
   

  	
   

  
	
  16.

  	
  Cooperation in Marketing

  	
  23

  
	
   

  	
   

  	
   

  
	
  17.

  	
  Marketing of Finished Goods

  	
  23

  
	
   

  	
   

  	
   

  
	
  18.

  	
  General Diligence of Anesta

  	
  24

  
	
   

  	
   

  	
   

  
	
  19.

  	
  Adverse Event Reporting; Suspension and Withdrawal
  of Products

  	
  24

  
	
   

  	
   

  	
   

  
	
  20.

  	
  New Technical Information and Inventions

  	
  24

  
	
   

  	
   

  	
   

  
	
  21.

  	
  Patent Protection for Inventions

  	
  26

  
	
   

  	
   

  	
   

  
	
  22.

  	
  Prosecution of the Licensed Patents and Approval
  Information

  	
  26

  
	
   

  	
   

  	
   

  
	
  23.

  	
  Infringement of the Licensed Rights

  	
  26

  
	
   

  	
   

  	
   

  
	
  24.

  	
  Infringement of Independent Third Party Rights

  	
  27

  
	
   

  	
   

  	
   

  
	
  25.

  	
  Confidentiality

  	
  28

  



 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


3

















 


	
  26.

  	
  Public Announcements

  	
  30

  
	
   

  	
   

  	
   

  
	
  27.

  	
  ImmuPharma Representations and Warranties

  	
  30

  
	
   

  	
   

  	
   

  
	
  28.

  	
  Anesta Representations and Warranties

  	
  32

  
	
   

  	
   

  	
   

  
	
  29.

  	
  Indemnification between the Parties

  	
  33

  
	
   

  	
   

  	
   

  
	
  30.

  	
  Insurance

  	
  34

  
	
   

  	
   

  	
   

  
	
  31.

  	
  Disclaimer

  	
  35

  
	
   

  	
   

  	
   

  
	
  32.

  	
  Ordinary Termination

  	
  35

  
	
   

  	
   

  	
   

  
	
  33.

  	
  Specific Performance and Extraordinary Termination

  	
  37

  
	
   

  	
   

  	
   

  
	
  34.

  	
  Effect of Extraordinary Termination

  	
  38

  
	
   

  	
   

  	
   

  
	
  35.

  	
  Further Consequences of Extraordinary Termination.

  	
  38

  
	
   

  	
   

  	
   

  
	
  36.

  	
  Assignments

  	
  41

  
	
   

  	
   

  	
   

  
	
  37.

  	
  Affiliates, Sub-Licensees and Sub-contracting

  	
  41

  
	
   

  	
   

  	
   

  
	
  38.

  	
  Oversight Committee

  	
  42

  
	
   

  	
   

  	
   

  
	
  39.

  	
  General Dispute Resolution and Arbitration

  	
  43

  
	
   

  	
   

  	
   

  
	
  40.

  	
  Waiver

  	
  44

  
	
   

  	
   

  	
   

  
	
  41.

  	
  General Assurances

  	
  44

  
	
   

  	
   

  	
   

  
	
  42.

  	
  Severability

  	
  44

  
	
   

  	
   

  	
   

  
	
  43.

  	
  Entire Agreement

  	
  44

  
	
   

  	
   

  	
   

  
	
  44.

  	
  Titles and Headings

  	
  44

  
	
   

  	
   

  	
   

  
	
  45.

  	
  Costs of Preparation

  	
  44

  
	
   

  	
   

  	
   

  
	
  46.

  	
  Notices

  	
  45

  
	
   

  	
   

  	
   

  
	
  47.

  	
  Force Majeure

  	
  46

  
	
   

  	
   

  	
   

  
	
  48.

  	
  No Agency, Partnership or Joint Venture

  	
  46

  
	
   

  	
   

  	
   

  
	
  49.

  	
  Benefit to Third Parties

  	
  46

  
	
   

  	
   

  	
   

  
	
  50.

  	
  Governing Law

  	
  46

  



 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


4

















 


1.             Definitions


 


1.1           Definitions.
For the purposes of this Agreement the following terms shall have the following
meanings:


 


(A)          “Accounting
Period” means each three month period ending on 31st March, 30th June, 30th
September or 31st December.


 


(B)           “Acquiror”
shall have the meaning given to it in Clause 33.7 hereof.


 


(C)           “Affiliate”
means, with respect to a Party, any other company, corporation or other Entity
which (directly or indirectly) owns, is owned by or is under common ownership
with such Party or any other Entity actually controlled by, controlling or
under common control with such Party. 
For purposes of this definition only, “ownership” or “control” shall
mean where one Entity owns or controls fifty percent (50%) or more of the
equity conferring voting rights and/or otherwise has the ability to direct the
business affairs of another Entity.


 


(D)          “Anesta
Technical Information” means as set forth in Clause 20.2 hereof.


 


(E)           “Anesta
Patents” means as set forth in Clause 20.4 hereof.


 


(F)           “Anesta
Sub-Licensee” means an Entity, other than an Affiliate of Anesta, that will
have been granted a license by Anesta or Anesta’s Affiliates to any of the
Licensed Patents, Licensed Technical Information or Licensed Trademarks on the
terms and conditions set forth in Clause 3.3 hereof or that has any enforceable
and unconditional agreement with or commitment from Anesta or its Affiliates
for the grant of such a sub-license.


 


(G)           “API”
(Active Pharmaceutical Ingredients) means the Lupuzor molecule (P140)
manufactured under GMP conditions with the appropriate analytical and stability
data, but without formulation.


 


(H)          “Business Day”
means any day when the banks in Zurich, Paris and New York are open for
business.


 


(I)            “Cephalon”
means Cephalon, Inc., incorporated in Delaware, U.S.A. and having its
principal place of business at 41 Moores Road, Frazer, PA 19355, U.S.A., who is
the indirect owner of 100% of the equity of Anesta.


 


(J)            “Clinical
Studies” means:


 


(1)        any study in man
involving the administration of the Licensed Product, the Licensed Molecules or
the Licensed Product to human beings, including studies in all phases of
clinical development (Phases I, II, III and IV); and


 


(2)        observational
studies concerning the effects of the Licensed Product, Licensed Molecules or the
Licensed Product in human beings, including post authorisation safety studies,
quality of life studies and pharmacoeconomic studies.


 


(K)          “CNRS” means the
Centre National de la Recherches Scientifiques, France.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


5

















 


(L)           “CNRS Agreements” means
collectively the CNRS/ImmuPharma License Agreement (as defined) as well as any
other collaboration agreements, license agreements, exploitation agreements
between CNRS and ImmuPharma (as amended from time to time) which pertain to the
Licensed Molecules, the Licensed Product or the Licensed Technical Information,
however only to the extent they so pertain to the Licensed Molecules, the
Licensed Product or the Licensed Technical Information.


 


(M)         “CNRS/ImmuPharma
License Agreement” means the license agreement L05152 executed between CNRS
and ImmuPharma on September 27th, 2005 and all subsequent
amendments, inclusing Amendment No. 1, as set forth on Schedule 4
to the Option Agreement.


 


(N)          “CNRS Lupuzor Patents” means those
Patents which are the subject under the CNRS/ImmuPharma License Agreement and
which are identified as Brevet1 and Brevet2 therein.


 


(O)          “CNRS Technical Information” means
any and all Technical Information Controlled by ImmuPharma on or after the
Effective Date, which is owned, co-owned or Controlled by CNRS, to the extent
such Technical Information relates to the Licensed Molecules or the Licensed
Product.


 


(P)           “Combination Product” shall mean any
composition which comprises the Licensed Molecules and at least another active
ingredient.


 


(Q)          “Commercial
Milestones” means as set forth in Clause 5.1 hereof.


 


(R)           “Commercial
Year” means, except with respect to the first Commercial Year, each
successive 12 calendar month period starting from the 01 January of one
year and ending on the 31 December of the same year. The first Commercial
Year shall begin on the date of the First Commercial Sale to occur in the
Territory and end on the 31 December of that year.


 


(S)           “Commercially
Reasonable Efforts” [**].


 


(T)           “Confidentiality
Agreement” means the Confidentiality Agreement made as of 15 June 2007
between ImmuPharma and Cephalon.


 


(U)          “Contract
Auditor” shall have the meaning given to it in Clause 10.1 hereof.


 


(V)           “Control”,
“Controls” or “Controlled” means the possession of the ability to
grant the licenses or sublicenses or disclose information as provided for
herein, without breaching the terms of any prior written agreement or other
arrangement with any Third Party.


 


(W)         “Decision Payment” means an amount equal to thirty million US
Dollars (US$30,000,000).


 


(X)          “Development Milestones” means as set forth in Clause 4.1 hereof.


 


(Y)           “Development
Program” means the development program for the Licensed Product,
Licensed Molecules or Licensed Product in the Territory, as contemplated in
Clause 11 and the other provisions of this Agreement, but as may be amended by
Anesta from time to time in accordance with the terms and conditions of this
Agreement and including all duties, studies, clinical trials, documents, reports
which are requested by Regulatory Authorities in order to obtain the
authorizations to apply for an IND or NDA in the countries of the Territory or
to get any applications for commercial marking authorization granted.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


6

















 


(Z)           “Dispute”
means any dispute that arises out of or in connection with this Agreement,
including any question regarding the existence, scope, validity or termination
of this Agreement.


 


(AA)       “Effective
Date” means the date on which this Agreement became effective under Clause
2.1 hereof.


 


(BB)        “EMEA”
shall mean the European Medicines Agency as may be competent for the approval
and registration of pharmaceutical products within the European Community.


 


(CC)        “EMEA Approval”
means the date of EMEA’s approval of an MAA for Licensed Product filed by or on
behalf of Anesta for marketing the Licensed Product in the [**].


 


(DD)       “EMEA Filing”
means any MAA filed with and accepted by EMEA for Licensed Product filed by or
on behalf of Anesta.


 


(EE)         “Entity”
means and includes any person, firm or company or group of persons or
unincorporated organization.


 


(FF)         “Escrow Agent” means Rinderknecht &
Burger, Grafenauweg 6, CH-6300 Zug, Switzerland, acting as escrow agent for the
Signed Agreements on behalf of ImmuPharma and Cephalon pursuant to Clause 2.1.


 


(GG)        “Finished
Goods” means any product containing Licensed Product which is fully
formulated in final form packed for ultimate consumer use and ready for use by
or administration to patients in the Territory including any packaging,
labelling and any necessary inserts.


 


(HH)       “First
Commercial Sale” means the first commercial sale of Finished Goods in the
Territory by Anesta or an Affiliate or a co-promoter (as defined in Clause 3.4) in accordance
with an NDA which has, prior to such sale, been approved in the Territory for
such Finished Goods.


 


(II)           “GAAP”
means generally-accepted accounting principles, consistently applied.


 


(JJ)          “Generic
Equivalent” [**]


 


(KK)       “Generic
Competition” [**]


 


(LL)         “Good Clinical
Practice” means the applicable principles and guidelines for good clinical
practices for drugs and medicinal products, as such principles and guidelines
are amended, implemented and supplemented from time to time, including those
set out in the ICH (as defined).


 


(MM)     “Good
Laboratory Practice” means the applicable principles and guidelines for
good laboratory practices for drugs and medicinal products, as such principles
and guidelines are amended, implemented and supplemented from time to time, including
those set out in the OECD Principles of Good Laboratory Practice published by
the Organisation for Economic Cooperation and Development from time to time.


 


(NN)       “Good
Manufacturing Practice” means applicable principles and guidelines for good
manufacturing practices for drugs and medicinal products, as such principles
and guidelines are amended, implemented and supplemented from time to time,
including the 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an application
for confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


7

















 


equivalent rules in the
USA to those set out in Title 21 Parts 210 and 211 of the US Code of Federal
Regulations (21CFR, parts 210 and 211) or found in European Directive
91/356/EEC and guidance made thereunder and published in Volume IV of “The rules governing
medicinal products in the European Union”.


 


(OO)       “ICH”
means the Harmonised Tripartite Guideline for Good Clinical Practice as
finalised by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use.


 


(PP)         “IFRS” means the International Financial
Reporting Standards adopted by the
International Accounting Standards Board.


 


(QQ)       “ImmuPharma
AG” means ImmuPharma AG, a Swiss corporation, having its present principal
place of business at Kägenstrasse 12, CH-4153 Reinach, Switzerland, which is an
Affiliate of ImmuPharma.


 


(RR)        “ImmuPharma Patents” means (i) any
and all Patents owned or co-owned by ImmuPharma on or after the Effective Date,
including any and all Patents added to the Licensed Patents either (x) pursuant
to Clause 20.6 of this Agreement or (y) under the CNRS Agreements (as
defined); (ii) any Patents owned or co-owned by ImmuPharma which claim
priority to such Patents; and (iii) any Patents which would be infringed
by the manufacture, use or sale of the Licensed Molecules or the Licensed
Products which are owned, co-owned or Controlled by ImmuPharma, other than the
CNRS Lupuzor Patents, all of (i), (ii) and (iii) however only to the extent
they relate to the Licensed Molecules, the Licensed Product or the Licensed
Technical Information.


 


(SS)         “ImmuPharma
Sub-Licensee” means an Entity, other than an Affiliate of ImmuPharma, that
will be granted a license by ImmuPharma or ImmuPharma’s Affiliates to any of
the Licensed Patents, Licensed Technical Information or Licensed Trademarks
outside the Territory upon termination in single countries on the terms and
conditions hereof.


 


(TT)        “ImmuPharma Technical
Information” means any and all Technical Information owned or co-owned by
ImmuPharma on or after the Effective Date which is related to the Licensed Molecules or the
Licensed Product and only to the extent it is so related thereto, including any
and all ImmuPharma Technical Information added to the Licensed Technical
Information pursuant to Clause 20.6 of the this Agreement.


 


(UU)       “IND”
means any approval, consent, clearance or exemption necessary to carry out,
sponsor, distribute or supply investigational drugs or medicinal products for a
Clinical Trial which is obtained through notification to or grant or
confirmation by a Regulatory Authority in any country or jurisdiction of the
Territory.


 


(VV)        “Independent
Third Party” means any person or Entity other than ImmuPharma or Anesta,
their Sub-Licensees, or their sub-contractors under Clauses 14.3 or 37 or any
Affiliates of the foregoing.


 


(WW)     “Invention(s)”
means any and all new inventions comprised in any Technical Information or
Know-How generated after the Effective Date by or on behalf of either Party or
its Affiliates, Sub-Licensees or sub-contractors to the extent relating to the
Licensed Molecules or Licensed Product.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


8

















 


(XX)       “[**] Approval”
means the date of [**]’s approval of an NDA filed by or on behalf of Anesta.


 


(YY)        “Know-How”
means (a) all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical,
physical and analytical, pre-clinical and clinical information and data,
technical information, trade secrets, specifications, instructions, processes,
formulae, expertise, information and documentation relating to the development,
registration, use, safety, quality control, manufacturing, or commercialization
of the Licensed Molecules or Licensed Product Controlled by ImmuPharma as of
the date hereof or obtained by ImmuPharma or either or both of Cephalon and
Anesta hereafter, including, without restriction, all know how related to the
Licensed Patents and the Licensed Technical Information obtained during the
term hereof, which is Controlled by ImmuPharma and which ImmuPharma has the
right to license to Cephalon or Anesta and which know-how is necessary or
useful for the development, registration, use, manufacture and
commercialization of the Licensed Molecules or Licensed Product on the terms
and conditions hereof and (b) all other technical information owned,
co-owned, Controlled or developed by or on behalf of ImmuPharma or any
Affiliate, licensee or sub-contractor thereof relating to the Licensed Patents
or the Licensed Technical Information (as the case may be).


 


(ZZ)        “Late Payment
Interest” shall mean as set forth in Clause 8.4 hereof.


 


(AAA)   “Licensed Molecules” means any molecule that
is a chemical derivative of a peptide corresponding to the sequence 131-151 of
the 70k-snRNP protein (i.e., RIHMVYSKRSGKPRGYAFIEY, which is SEQ ID NO: 1 of
U.S. patent application serial number 10/236,468), including derivatives in
which a Lysine (in position 138 or 142) is acetylated or a Serine (in position
137 or 140) is phosphorylated, any combination thereof and in particular
Lupuzor, and the esters, amides, salts, hydrates and solvates thereof.


 


(BBB)     “Licensed
Patents” means the:


 


(1)        ImmuPharma
Patents; and


 


(2)        Third Party
Patents.


 


(CCC)     “Licensed
Product” means any formulations or dosages that contain the Licensed
Molecules, including but not limited to any Combination Product, for any and
all uses.


 


(DDD)    “Licensed Technical Information” means any and
all ImmuPharma Technical Information and Third Party Technical Information.


 


(EEE)      “Licensed
Trademarks” means the marks LUPUZOR, LUPUSOL and LUPUSTAT and any other
word marks, designs or logos that ImmuPharma may apply for, register, create,
own or use in the future in respect of the Licensed Products or Licensed
Molecules, including but not limited to, those marks listed on Schedule 1
of the Trademark License Agreement and any amendments thereto.


 


(FFF)      “Lupus” means a systemic chronic
inflammatory disease also known as Systemic Lupus Erythematosus (SLE) as
defined by the American College of Rheumatology classification criteria for SLE
(1997) and as set forth in Schedule 6 of the Option Agreement.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


9

















 


(GGG)     “Lupuzor” means IPP-201101, otherwise known as P140, which is
the peptide corresponding to the sequence 131-151 of the 70k-snRNP protein with
a phosphorylated “Ser” in position 140, the chemical structure of which is
given in Schedule 3, and the esters, amides, salts, hydrates and
solvates thereof.


 


(HHH)    “Lupuzor Committee”
means the committee established pursuant to Clause 11.4 hereof.


 


(III)         “MAA”
means a Marketing Authorization Application as prescribed under the applicable
jurisdiction.


 


(JJJ)        “Main
Countries” [**]


 


(KKK)    “Manufacturing Data”
means all Know-How and Technical Information relating to the manufacture of the
Licensed Molecules or Licensed Product.


 


(LLL)      “Mediation
Notice” shall have the meaning given to it in Clause 39.4 hereof.


 


(MMM) “MHLW” means the [**]
and any successor organisation.


 


(NNN)    “NDA” means any
application or notification made to and accepted by a Regulatory Authority for
approval for Finished Goods to be placed on the market or sold for public
consumption as drugs or medicinal products, including without limitation a “shonin”
granted by the MHLW.


 


(OOO)    “NDA Approval”
hereunder means the date of the FDA’s approval of an NDA filed by or on behalf
of Anesta for marketing Licensed Molecules or Licensed Product in the U.S.A.


 


(PPP)      “NDA Filing”
hereunder means the earlier of (a) Anesta’s receipt of notice from the FDA
of the acceptance for review of an NDA submitted by or on behalf of Anesta to
market Licensed Molecules or Licensed Product in the U.S.A., or (b) the
seventy-fifth (75th)  calendar day
after submission to the FDA of an NDA by or on behalf of Anesta to market
Licensed Molecules or Licensed Product in the U.S.A.


 


(QQQ)    “Net Sales” for any
given period shall mean the gross aggregate amount invoiced on account of sales
of Finished Goods by Anesta or any of its Affiliates, Anesta Sub-Licensees or
their co-promoters (as defined in Clause 3.4) to an Independent Third
Party in the Territory (but not including sales between Anesta, its Affiliates,
Anesta Sub-Licensees or their co-promoters where the Licensed Molecules or
Licensed Product is intended for resale) less the following reductions directly
relating to such sales of Finished Goods:


 


(a) trade
and quantity discounts or rebates given in the ordinary course of business
which are not already reflected in the amount invoiced;


 


(b) any
adjustments or allowances on account of price adjustments, billing errors,
rejected goods, damaged goods and returns;


 


(c) credits,
volume rebates, charge-back and prime vendor rebates, fees, reimbursements or
similar payments granted or given to wholesalers and other distributors, buying
groups, health care insurance carriers, pharmacy benefit management companies,
health maintenance organizations or other institutions or health care
organizations, which are not already reflected in the amount invoiced;


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an application
for confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


10
















 


(d) any tax
associated with the sales of goods such as VAT, sales tax, tariff, customs
duty, excise or other duty or other governmental charge (other than a Tax on
income) levied on the sale, transportation or delivery of the Licensed
Molecules or Licensed Product and borne by the seller thereof, itemized on the
applicable invoice and remitted to the applicable taxing authority;


 


(e) payments
or rebates paid in connection with sales of the Licensed Molecules or Licensed
Product to any governmental or regulatory authority in respect of any state or
federal Medicare, Medicaid or similar programs, which are not already reflected
in the amount invoiced;


 


(f) any
invoiced charge for freight, insurance or other transportation costs charged to
the customer, in each case only when separately shown on the invoice; and


 


(g) amounts
allocated to bad debts.


 


PROVIDED THAT in any event
deductions may only be made under (a) to (g) to the extent they are
truly, fairly and equitably allocated to the Net Sales of Finished Goods of
Licensed Molecules or Licensed Product so that such do not bear a
disproportionate portion of such deductions. For purposes of this definition,
the Licensed Molecules or Licensed Product shall be considered “sold” and “reductions”
allowed when recorded as invoiced in Anesta’s, its Affiliates, Anesta
Sub-Licensees or co-promoters financial statements prepared in accordance with
US GAAP.


 


(RRR)     “Non-Exclusive”
or “Non-Exclusivity” means that ImmuPharma and its Affiliates shall have
the right pursuant to Clause 33.5 to evaluate, develop, keep, use, make, have
made, market, sell, have sold, import, have imported, export, have exported or
otherwise exploit or grant any licenses or sublicenses to any Third Parties to
the Licensed Patents or the Licensed Technical Information for the Licensed
Product or Licensed Molecules in one or more specific countries of the
Territory to the extent such right of ImmuPharma is required as a result of any
applicable antitrust act or competition law regulation.


 


(SSS)      “Option”
means the option granted by ImmuPharma to Cephalon and Anesta under a certain
option agreement, dated November 21, 2008.


 


(TTT)     “Ordinary
Termination” means as set forth in Clause 32.1 hereof.


 


(UUU)    “Oversight Committee”
means the committee established in accordance with Clause 38.


 


(VVV)     “Parent
Guarantee Agreement” [**]


 


(WWW) “Patents” means any and
all of the following to the extent they relate to the Licensed Molecules or the
Licensed Product:


 


(1)        patents and
patent applications;


 


(2)        utility models
and utility model applications;


 


(3)        substitutions,
divisions, continuations, continuations-in-part, reissues, renewals,
registrations, confirmations, re-examinations, Patent Term Extensions and the
like, and any provisional applications, of any such patents or patent
applications, utility models and utility model applications;


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


11

















 


(4)        improvements of
any of the foregoing;


 


(5)        foreign or
international equivalents of any of the foregoing; and


 


(6)        any other patents
which may issue from the foregoing.


 


(XXX)    “Patent Term Extension”
means any patent term extension, supplementary protection certificate or like
protection granted by any government, authority or agency.


 


(YYY)     “Positive
Decision Notice” shall have the meaning set forth in Clause 2.1 hereof.


 


(ZZZ)     “Pre-Clinical
Study” means any one of those studies, other than Clinical Studies and
studies intended to generate Manufacturing Data, carried out on the Licensed
Molecules or Licensed Product which are required to be carried out in order to
obtain the grant of an IND or NDA, including without limiting the generality of
the foregoing toxicology, pharmacokinetics, drug metabolism and pharmacology
studies, in each case which do not involve administration of Licensed Molecules
or Licensed Product to humans (and “Pre-Clinical Studies” shall be
construed accordingly).


 


(AAAA) “Regulatory
Authorities” means any and all governmental or supra-national agencies,
ministries, authorities or other bodies having responsibility for the
regulation or control of drugs or medicinal products.


 


(BBBB)   “Relevant Conditions”
shall have the meaning set forth in Clause 24.2(C).


 


(CCCC)   “Running Royalties”
mean as set forth in Clause 6 hereof.


 


(DDDD) “Significant Generic Competition”
means a level of Generic Competition [**]


 


(EEEE)    “Specification”, in
respect of a given compound, product or material, means:


 


(1)        in relation to
the Licensed Products or Licensed Molecules and any other compounds, products
or materials which are supplied by or on behalf of ImmuPharma under this
Agreement, the specification agreed in writing between ImmuPharma and Anesta;


 


(2)        in relation to
compounds, products and materials to be used in Pre-Clinical Studies and
Clinical Studies that are not supplied by or on behalf of ImmuPharma under this
Agreement, the final specification(s) developed for the relevant Clinical
Trial in accordance with any applicable IND and otherwise in accordance with
the applicable protocol for the Pre-Clinical Study or Clinical Trial; or


 


(3)        in relation to
all Finished Goods, the specification(s) given in any applicable NDA.


 


(FFFF)    “Sub-Licensee” and “Sub-Licensees”
means as the context requires either or both of an Anesta Sub-Licensee or an
ImmuPharma Sub-Licensee or Anesta Sub-Licensees and ImmuPharma Sub-Licensees if
referred to collectively.


 


(GGGG)   “Tax” or “Taxes”
means all of the following: (i) any net income, alternative or add-on
minimum tax, gross income, gross receipts, sales, use ad valorem, transfer,
franchise, profits, license, excise, severance, stamp, occupation, employment,
payroll, production, withholding, value added, premium, property,
environmental, or windfall profits tax or other tax, custom, duty or other tax,
governmental fee or other like assessment or charge of any kind whatsoever
together with interest or penalty additional to tax that may be 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


12

















 


imposed by any Governmental
or Regulatory Authority and (ii) any liability for the payment of amounts
described in (i) above as a result of being a member of an affiliated,
consolidated, combined or unitary group for any taxable period.


 


(HHHH) “Technical Information”
means any and all proprietary information, methods, procedures, designs, data
discoveries, techniques, formulae and intellectual property of any kind
relating to the Licensed Molecules or Licensed Product hereunder and shall
include, without limitation, Know-How, Manufacturing Data and the results of
and documentation associated with Pre-Clinical Studies and Clinical Studies.


 


(IIII)        “Territory”
means all the countries of the world, other than those countries which cease to
be a part of the Territory or become Non-Exclusive as provided for in Clause
33.5.


 


(JJJJ)       “Third Party”
or “Third Parties” means any party, person or Entity, other than a Party
hereto or an Affiliate, Sub-Licensee, permitted sub-contractor or co-promoter
of a Party hereto.


 


(KKKK) “Third Party Claim”
shall have the meaning given to it in Clause 24.1 hereof.


 


(LLLL)    “Third Party License
Agreements” shall have the meaning set forth in Section 9.1(M) of
the Development and Commercialization Option Agreement.


 


(MMMM)   “Third
Party Patents” means (i) the CNRS Lupuzor Patents and any and all
other Patents Controlled by ImmuPharma on or after the Effective Date that
relate to the Licensed Molecules or the Licensed Product and only to the extent
that they relate to the Licensed Molecules and the Licensed Product, including
any and all Patents added to the Licensed Patents pursuant to Clause 20.6 of
the Development and Commercialization Agreement, but not including the
ImmuPharma Patents, (ii) any patents Controlled by ImmuPharma which claim
priority to such patents and (iii) any patents which would be infringed by
the manufacture, use or sale of the Licensed Molecules or the Licensed Product
which are Controlled by ImmuPharma.


 


(NNNN) “Third Party Technical
Information” means the CNRS Technical Information and any and all other
Technical Information Controlled by ImmuPharma on or after the Effective Date,
but not including the ImmuPharma Technical Information.


 


(OOOO) “Trademark License Agreement” means the certain
trademark license agreement between ImmuPharma AG and Anesta set forth in Schedule
1-B to the Option Agreement.


 


(PPPP)    “Valid Claim” shall
mean any claim of an issued Licensed Patent that has not been revoked or held
invalid or unenforceable by a decision of a patent office, court or other
government agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal which covers the Licensed Product or the Licensed
Molecule.


 


1.2           Sections
and Clauses. The “Clauses” of this Agreement are
the numbered provisions of this Agreement.


 


1.3           Singular
and Plural. The singular includes the plural and vice
versa, words denoting any gender include all genders.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


13

















 


1.4           Parties’
References. Where the context so admits or requires
references to ImmuPharma or Anesta and their Affiliates, Sub-Licensees,
sub-contractors or co-promoters, such terms shall include their respective
employees, officers, directors and agents.


 


1.5             Manufacture
and Manufacture Activities. For the avoidance of
doubt, the terms “manufacture” and “manufacturing activities”
shall, in respect of Lupuzor, materials produced for use in Pre-Clinical
Studies and Clinical Studies and Finished Goods, include purchase of starting
and packaging materials, storage, production and packaging operations, release
of products, stability studies, and all related testing and quality control
procedures.


 


2.             Payment
of the Decision Payment and Effective Date of Agreement


 


2.1           Conditions
Precedent. This Development and Commercialization Agreement
shall only become effective upon the occurrence of all of the following: (i) Cephalon
acting also on behalf and for the account of Anesta has sent a written notice
to ImmuPharma, indicating a final decision to exercise the Option (“Positive
Decision Notice”), and (ii) payment by Cephalon, and receipt by
ImmuPharma, of the Decision Payment.  For
the avoidance of doubt, this Development and Commercialization Agreement shall
be executed by all Parties required to execute this Agreement at the time of
execution of the Option Agreement, in advance of the satisfaction of each of
the foregoing subsections (i) and (ii) but this Agreement shall only
be in full force and effect after the occurrence of any and all of (i) and
(ii) above. All signed copies hereof shall be deposited with the Escrow
Agent who shall hold all the Signed Agreements in escrow for the Parties
hereto. Upon the occurrence of all of (i) and (ii) above, the Escrow
Agent shall release one fully executed copy of this Agreement, signed by
ImmuPharma, Cephalon and the Escrow Agent, to each of the signatories hereof.
Should either (i) or (ii) not occur within the Option Period, the
Escrow Agent shall destroy all Signed Agreements.


 


2.2           Decision Payment.
Once both of Clause 2.1 (i) and (ii) above have occured, the Decision
Payment shall be irrevocable and non-refundable.


 


3.             Grant


 


3.1           License.
ImmuPharma hereby grants on the terms and conditions hereof to Anesta and its
Affiliates an exclusive (as set forth hereinafter and even as to ImmuPharma and
its Affiliates) license to the:


 


(A)          ImmuPharma
Patents to evaluate, develop, keep, use, make, have made, market, sell, have
sold, import, have imported, export, have exported and otherwise exploit the
Licensed Products or Licensed Molecules within the Territory; and


 


(B)           ImmuPharma
Technical Information to evaluate, develop, keep, use, make, have made, market,
sell, have sold, import, have imported, export, have exported and otherwise
exploit the Licensed Products or Licensed Molecules in the Territory.


 


Anesta and its Affiliates  shall be the sole and exclusive licensee of ImmuPharma in
respect of the ImmuPharma Patents and the ImmuPharma Technical Information for
the Licensed Product or Licensed Molecules in the Territory.  “Exclusive” shall
mean that for as long as this Agreement is in full force and effect neither
ImmuPharma nor its Affiliates shall evaluate, develop, keep, use, make, have
made, market, sell, have sold, import, have imported, export, have exported or
otherwise exploit or grant any licenses or sublicenses to any Third Parties to
the ImmuPharma Patents or the ImmuPharma Technical Information for the Licensed
Product or Licensed Molecules within the Territory other than for the
manufacturing of Licensed Products or Licensed Molecules within the Territory
by a manufacturer of its choice exclusively and solely for the delivery of 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


14

















 


Licensed Products or
Licensed Molecules to such country outside the Territory in which a partial
termination hereof under Clause 33.5 has taken place or the license granted
hereunder has become Non-Exclusive under Clause 33.5 on the terms and
conditions thereof.


 


3.2           Sub-License.
ImmuPharma hereby grants on the terms and conditions hereof to Anesta and its
Affiliates an exclusive (as set forth hereinafter and even as to ImmuPharma and
its Affiliates) sub-license to the:


 


(A)                           Third Party
Patents to evaluate, develop, keep, use, make, have made, market, sell, have
sold, import, have imported, export, have exported and otherwise exploit the
Licensed Products or Licensed Molecules within the Territory; and


 


(B)                                Third Party
Technical Information to evaluate, develop, keep, use, make, have made, market,
sell, have sold, import, have imported, export, have exported and otherwise
exploit the Licensed Products or Licensed Molecules in the Territory.


 


Anesta and its Affiliates
shall be the sole and exclusive sub-licensee of ImmuPharma in respect of the
Third Party Patents and the Third Party Technical Information for the Licensed
Product or Licensed Molecules in the Territory.  “Exclusive” shall mean that
for as long as this Agreement is in full force and effect neither ImmuPharma
nor its Affiliates shall evaluate, develop, keep, use, make, have made, market,
sell, have sold, import, have imported, export, have exported or otherwise
exploit or grant any licenses or sublicenses to any Third Parties to the Third
Party Patents or the Third Party Technical Information for the Licensed
Molecules or Licensed Product within the Territory other than for the
manufacturing of Licensed Products or Licensed Molecules by a manufacturer of
its choice exclusively and solely for the delivery of Licensed Products or
Licensed Molecules to such country outside the Territory in which the license
or sublicense granted in this Agreement has been terminated or becomes Non-Exclusive
pursuant to Clause 33.5.


 


3.3           Anesta’s Right to
Sub-License. Anesta may (i) sub-license any and all
rights granted to it hereunder to its Affiliates and Cephalon’s Affiliates and (ii) sub-license
any and all rights granted hereunder to Third Parties to produce or use the
Licensed Molecules or Licensed Product in the Territory. [**] In addition, each
sublicense to a Third Party shall be subject to the due fulfilment of all the
following prerequisites:


 


(A)                              [**];


 


(B)                                [**];


 


(C)                                [**]; and


 


(D)                               [**].


 


ImmuPharma shall use Commercially Reasonable
Efforts to facilitate the grants of sublicenses by Anesta on the terms and
conditions hereof.


 


3.4           Co-Promoting.
Clause 3.3 shall not prevent Anesta, its Affiliates or Sub-Licensees from
selling Finished Goods in the Territory in conjunction with a co-promoter. For
these purposes, a “co-promoter” shall mean an Independent Third Party
which sells Finished Goods.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


15

















 


4.             Development
Milestone Payments


 


4.1           Events. Anesta
shall make the following irrevocable and non-conditional payments to ImmuPharma
upon the occurrence of the following development milestone events (each a “Development
Milestone” and all the “Development Milestones”):


 


(A)                              [**] first
acceptance of an NDA Filing for the Lupus indication for the Licensed Product
in the USA; and


 


(B)                                [**] first NDA
Approval (as defined) for the Lupus indication for the Licensed Product in the
USA; and


 


(C)                                [**] first
acceptance of an EMEA Filing (as defined) for the Lupus indication for the
Licensed Product in Europe; and


 


(D)                               [**] first EMEA
Approval (as defined) for the Lupus indication for the Licensed Product in
Europe; and


 


(E)                                 [**].


 


4.2           Payment Terms.
For the avoidance of doubt:


 


(A)          The individual
Development Milestones shall be cumulative, but each Development Milestone
payment shall be due and payable only once in respect of the first time that
the relevant development milestone event occurs in relation to the Licensed
Product.


 


(B)           The payment of
each Development Milestone payment is not conditional or dependent in any way
upon whether or not any approvals for price or reimbursement are obtained for
the Territory.


 


5.             Commercial
Milestone Payments


 


5.1           Events.
Anesta shall make the following irrevocable and non-conditional payments to
ImmuPharma upon the occurrence of the following commercial milestone events
(each a “Commercial Milestone” and collectively, the “Commercial
Milestones”):


 


(A)                              [**] the end of any Commercial Year in
which Net Sales for such Commercial Year exceed [**]; and


 


(B)                                [**] the end of any Commercial Year in
which Net Sales for such Commercial Year exceed [**]; and


 


(C)                                [**] the end of any Commercial Year in
which Net Sales for such Commercial Year exceed [**].


 


5.2           Payment Terms.
For the avoidance of doubt:


 


(A)          the Commercial
Milestone payments under Clause 5.1(A), (B) and (C) shall be
cumulative, but each Commercial Milestone payment shall be due and payable only
once in respect of the first time that the relevant Commercial Milestone event
occurs in relation to the Licensed Product; and


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


16

















 


(B)           If more than one
Commercial Milestone is achieved for the first time in any given calendar year
following the end of any Commercial Year therein, then the Commercial Milestone
payments in respect of each such Commercial Milestone shall become due and
payable.


 


6.             Running
Royalties


 


6.1           Rates. As
further consideration for the licenses and rights hereby granted, Anesta shall
pay to ImmuPharma running royalties based on the Net Sales for each Commercial
Year as set out below (the “Running Royalties”):


 


(A)                              in respect of all
Net Sales of less than [**]in any given Commercial Year, the Running Royalties
shall be [**]; and


 


(B)                                in respect of the
portion, if any, of all Net Sales between [**] in any given Commercial Year,
the Running Royalties shall be [**]; and


 


(C)                                in respect of the
portion, if any, of all Net Sales between[**] in any given Commercial Year, the
Running Royalties shall be [**]; and


 


(D)                               in respect of the
portion, if any, of all Net Sales between [**] and in any given Commercial
Year, the Running Royalties shall be [**]; and


 


(E)                                 in respect of the
portion, if any, of all Net Sales over [**] in any given Commercial Year, the
Running Royalties shall be [**].


 


6.2           Significant
Generic Competition.  [**]


 


6.3           Combination
Products. In the event a Combination Product is sold by
Anesta, the Net Sales from the Combination Product, for the purposes of
determining Running Royalties and the Commercial Milestone payments, shall be
determined by multiplying the Net Sales of the Combination Product (as defined
in the standard Net Sales definition), during the applicable reporting period,
by the fraction, A/A+B, where A is the weighted (by sales volume) average sale
price of the Licensed Molecules or Licensed Product when sold separately in
finished form and B is the weighted (by sales volume) average sale price of the
other product(s) included in the Combination Product when sold separately
in finished form, in each case during the applicable reporting period or, if
sales of both the Licensed Molecules or Licensed Product and the other product(s) did
not occur in such period, then in the most recent reporting period in which
sales of both occurred. In the event that such average sale price cannot be
determined for both the Licensed Molecules or Licensed Product and all other
products(s) included in the Combination Product, Net Sales for the
purposes of determining Commercial Milestone payments and Running Royalties
shall be mutually agreed by the Parties based on the relative value contributed
by each component, such agreement not to be unreasonably withheld.


 


7.             Timing
and Statement of Royalty and Milestone Payments


 


7.1           Timing.
Payment of Running Royalties shall be made by Anesta to ImmuPharma on a
quarterly basis within sixty (60) calendar days after the end of each
Accounting Period in respect of all Net Sales occurring in such Accounting
Period.


 


7.2           Statement.
However, within thirty (30) calendar days after the end of each such Accounting
Period, Anesta shall provide ImmuPharma with the written statement referred to
in Clause 8.3.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


17

















 


8.             Accounting
and Other Financial Provisions Relating to Royalties and Other Payments


 


8.1           Milestone
Notification. Anesta undertakes to notify ImmuPharma in
writing of each Development Milestone event referred to in Clause 4 within
fourteen (14) calendar days of its occurrence and of each Commercial Milestone
event referred to in Clause 5 within thirty (30) calendar days after the end of
the Commercial Year in respect of which it occurs.


 


8.2           Accounting.
Anesta shall, and shall procure that each Affiliate and each
Anesta Sub-Licensee shall, keep at its usual place of business complete proper
records and books of account showing the quantity, description and Net Sales
(including gross invoiced prices and any deductions made therefrom) of Finished
Goods sold and/or used hereunder on a product presentation-by-product
presentation basis.


 


8.3           Running Royalties Reporting. Within thirty (30) calendar days after each Accounting Period, Anesta
shall deliver to ImmuPharma a detailed written statement of all Net Sales of
Licensed Product in the Territory by Anesta, its co-promoters under Clause
3.4, Affiliates and Anesta Sub-Licensees,
if any, as well as all Running Royalties due and payable to ImmuPharma for the
relevant Accounting Period showing separately the transactions for which
Running Royalties are payable and (where relevant), the rate of exchange used
or, if it be the case, a statement that no Running Royalties are due, whereby
Clause 10 remains reserved.


 


8.4           Late Payment
Interest. Where any Milestones, Running Royalties, charges
or other sums payable by Anesta to ImmuPharma hereunder remain unpaid after the
date on which they became due and payable, Anesta shall pay to ImmuPharma
interest calculated from the date upon which the sums became due until payment
thereof at the ninety-day London Interbank Offered Rate prevailing on the due date
[**], hereafter the “Late Payment Interest”.


 


9.             Remittance,
Currency and Taxes


 


9.1           Payments. The Decision Payment,
all Milestone payments under Clauses 4 and 5 and all Running Royalties payments
under Clause 6 shall be made electronically in US Dollars and to such place and
account as may be designated from time to time for that purpose by ImmuPharma
to Anesta in writing. Any necessary currency conversions in connection with
Running Royalties payments shall be made by Anesta in accordance with the financial
reports prepared, and financial reporting procedures operated, in accordance
with the United States GAAP. All payments shall be made by Anesta in accordance
with Clause 9.2.


 


9.2           Withholding Taxes. All
sums payable by either Party under this Development and Commercialization
Agreement (including without limitation the Decision Payment and all Milestones
and Running Royalties payments) shall be paid in full and without any
Taxes, duties, levies, fees, charges, deduction
or withholding, except as may be required by law.  If it shall appear that any such sum is or is
likely to be or become subject to any such Taxes, duties, levies, fees,
charges, deduction or withholding as
aforesaid the Parties shall consider together to what extent, if at all, it may
lawfully be possible to mitigate the amount of such deduction or withholding or
of the amount required to be paid as aforesaid, including making Commercially
Reasonable Efforts to make timely and procedurally correct application for
relief from withholding Tax in respect of any such payment.  For any Taxes withheld or to be withheld,
each party agrees to timely deliver all certificates and forms as may be
necessary and appropriate to establish an exemption from Tax or file Tax
returns as would be necessary with respect to such Taxes.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


18

















 


10.           Audit of
Financial Milestones, Royalties, Cost of Goods etc.


 


10.1         Audits.  Once each calendar year, Anesta shall permit
any professionally qualified representatives from an independent firm of
accountants appointed by ImmuPharma or CNRS (as to which Anesta has no
reasonable objection) (“Contract Auditor”),
upon [**] days advance written notice and subject to such representatives
undertaking not to disclose or use any of Anesta’s confidential information
(save for the purposes set out in this Clause 10.1), access during normal
business hours to the premises, accounts, records and relevant documentation
for [**] of Anesta, its Affiliates, Anesta Sub-Licensees and co-promoters under
Clause 3.4, and all thereof shall provide such information and explanations as
the Contract Auditor shall reasonably require for the purposes of verifying the
statements and reporting to ImmuPharma and CNRS whether the provisions of this
Agreement or the Trademark License Agreement are being complied with and the
extent to which Anesta has paid any sums due and payable on the terms and
conditions of this Agreement or the Trademark License Agreement. ImmuPharma
shall pay all costs of the Contract Auditor. For the avoidance of doubt,
ImmuPharma shall only be permitted to conduct one audit in each calendar year,
regardless of whether it is conducted pursuant to this Agreement or the
Trademark License Agreement. The report by the Contract Auditor to ImmuPharma
and CNRS (with a copy to Anesta) shall not include any confidential information
of Anesta except to the extent reasonably necessary to report whether or not
Anesta, its Affiliates, Anesta Sub-Licensees and co-promoters under Clause 3.4,
have correctly paid all sums due and payable under this Agreement or the
Trademark License Agreement and, if not, the specific details of any
discrepancies. Anesta shall keep and retain, and shall ensure that its
Affiliates and Anesta Sub-Licensees and co-promoters under Clause 3.4 shall
keep and retain, such accounts, records and documentation for at least three (3) calendar
years from the date of their origin, or such longer period as may be required
by applicable law. The Contract Auditor shall also be permitted to take copies
and extracts solely for the purpose of performing the verification exercise
contemplated under this Clause 10.1. Such copies and extracts shall be returned
to Anesta on completion of the verification exercise and resolution of any
issues which have arisen. If the Contract Auditor shall determine that there is
an underpayment to ImmuPharma of [**] of the particular amount due under either
this Agreement or the Trademark License Agreement for any relevant Accounting
Period, ImmuPharma shall provide written notice to Anesta and Anesta shall,
within thirty (30) calendar days of the written demand by ImmuPharma, pay to
ImmuPharma the deficient amount (the underpayment) plus Late Payment Interest
calculated pursuant to Clause 8.4. If the Contract Auditor shall determine
that there is an overpayment by Anesta of [**] of the particular amount due
under either this Agreement or the Trademark License Agreement for any relevant
Accounting Period, Anesta shall provide written notice to ImmuPharma with reasonable
detail. ImmuPharma shall, within thirty (30) calendar days of the written
demand by Anesta, pay to Anesta the excess amount (the overpayment) plus Late
Payment Interest described in Clause 8.4. 
For the avoidance of doubt, the calculation of any underpayment or
overpayment shall not be an aggregate of any underpayment or overpayment in
this Agreement and any underpayment or overpayment in the Trademark License
Agreement.


 


10.2         Amicable
Settlement. Where the Parties disagree over whether or
not any amounts are payable following any verification by the Contract Auditor
under Clause 10.1 their chief financial officers (or appropriately qualified
senior management who are designated by such chief financial officers) shall
discuss the disagreement in good faith with the Contract Auditor who performed
the verification exercise. If the matter is not resolved within one (1) calendar
month of the date any written demand is made under the last sentence of Clause
10.1, the matter shall be referred to the Oversight Committee. If not agreed
within the Oversight Committee within fifteen (15) Business Days of such
referral, either Party may elect to have the matter determined by a senior
professionally qualified representative of the firm of an independent firm of
accountants to be reasonably agreed by the Parties, which may or may not be the
Contract Auditor who performed the 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


19

















 


verification exercise,
acting as an expert.  Such expert
determination shall be final and binding upon the Parties. Notwithstanding
anything to the contrary herein, the resolution of any Dispute under this
Clause 10.2 shall be made under this Clause 10.2 instead and in lieu of Clause
39.


 


10.3         CNRS Rights. It is understood and acknowledged by the
Parties that CNRS pursuant to the CNRS Agreements has the right to inspect and
review the Net Sales figures for the purpose of calculating their Running
Royalties due by ImmuPharma and that as a consequence all rights of ImmuPharma
under this Clause 10 may also be exercised by CNRS in addition to
ImmuPharma.  To the extent ImmuPharma
desires to conduct an audit in any calendar year, ImmuPharma shall use
Commercially Reasonable Efforts to agree with CNRS that in any such calendar
year only one audit shall be conducted. ImmuPharma shall not be permitted to
conduct an audit in any calendar year in which CNRS has already conducted or
plans to conduct an audit.


 


11.           Development
of Licensed Product


 


11.1         Commercially
Reasonable Efforts. [**]


 


11.2         Costs and Expenses.
Subject to any express provisions of this Agreement to the contrary, Anesta
shall be exclusively responsible for developing Licensed Product for the
Territory and shall bear all costs and expenses associated with such
development for the Territory.


 


11.3         Approval and
Commercialization Strategy. Besides the regulatory
strategy, filing and approval planning and implementation in the Development
Program, Anesta shall also develop a commercialization strategy and program for
the Territory.


 


11.4         Lupuzor Committee.
The Development Program shall be under the exclusive responsibility of Anesta
and Anesta shall be responsible for all costs and expenses related to the
development and commercialization of Licensed Product(s) for the
Territory. ImmuPharma shall be kept informed on the progress of development and
commercialization through a Lupuzor Committee (the “Lupuzor Committee”)
which shall be established promptly following the Effective Date.  The Lupuzor Committee shall have five members
including the Chairman.  Three members
including the Chairman shall be appointed in writing by Anesta and two members
shall be appointed in writing by ImmuPharma. 
Each Party shall appoint a representative to be responsible, in case of
Anesta, for the overall day-to-day implementation and supervision of the
Development Program. The representative of Anesta shall keep the representative
of ImmuPharma and the Lupuzor Committee regularly and fully informed of the
progress of the Development Program and shall provide the members of the
Lupuzor Committee at annual intervals (or such other shorter intervals as may
be agreed within the Lupuzor Committee) with a written summary of the results
of the work in the development and commercialization of Licensed Product.
Anesta shall ensure that all Pre-Clinical Studies and Clinical Studies which
are conducted by or on behalf of Anesta its Affiliates or Anesta Sub-Licensees
are conducted with Commercially Reasonable Efforts and in a timely and diligent
manner in accordance with applicable current Good Laboratory Practice, Good
Clinical Practice and Good Manufacturing Practice (where appropriate) and
Anesta shall use all Commercially Reasonable Efforts to ensure that each phase
and category of the work in the Pre-Clinical Studies and Clinical Studies
involving Licensed Product for which Anesta, its Affiliates, Anesta
Sub-Licensees and permitted sub-contractors on the terms and conditions of
Clause 37, are responsible is completed in a timely manner.


 


11.5         IND’s.
Unless otherwise agreed in writing, Anesta shall have sole responsibility, by
itself or through its Affiliates or Anesta Sub-Licensees, for applying for,
updating and maintaining all INDs within the Territory and for ensuring that
all requirements and conditions imposed upon the holder of such INDs are fully
complied with at all times. However, upon the reasonable request of Anesta,


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


20
















 


ImmuPharma shall
provide reasonable assistance and cooperation in connection with such
activities in relation to providing Technical Information requested by Anesta
which is in ImmuPharma’s possession and Controlled by ImmuPharma and procuring
that its staff, where necessary, attend regulatory hearings and are reasonably
available to discuss matters specific to the Licensed Product. Anesta shall
reimburse to ImmuPharma all reasonable costs and expenses, including without
limitation all costs of materials, active ingredients and excipients, package,
delivery and transport and the fair and proportional allocation of overhead
costs of ImmuPharma’s personnel consistent with applicable IFRS.


 


11.6         Development
Program.  [**]


 


11.7         Publications.
ImmuPharma shall not publish anything related to the Licensed Product, Licensed
Molecules or the subject matter of the Licensed Patents without the prior
written consent of Anesta or its Affiliates, provided that nothing in this
Clause 11.7 shall prevent ImmuPharma from making disclosures where
permitted to do so under Clause 26.3, provided that ImmuPharma shall use all
reasonable efforts to strictly adhere to the provisions in this
Clause 11.7. For the avoidance of doubt, Anesta shall have the right to
publish information related to the Licensed Product, Licensed Molecules and the
subject matter of the Licensed Patents as necessary to make regulatory filings,
for publication of results of Clinical Studies or otherwise related to the
development or commercialization of the Licensed Products.


 


12.           Production and Supply of Materials for the Development Program


 


12.1         Applicable
Rules. Anesta shall be responsible for producing all
materials necessary or advisable for a successful Development Program. It will
ensure that such activities are performed in accordance with all applicable
laws, regulations, guidelines and standards, including applicable current Good
Manufacturing Practice and that, to the extent applicable, such materials are
manufactured to the applicable Specification.


 


12.2         Quality
Control. It shall be Anesta’s sole responsibility at Anesta’s
sole cost and expense to ensure that the appropriate approvals shall be
obtained for the import into the Territory of any materials necessary or
advisable to properly perform the Development Program and to ensure that all
necessary or advisable quality control procedures and other pharmaceutical
activities are performed to prove that the materials comply with Good
Manufacturing Practice and follow the Specifications before such imported
materials are released for use in any country of the Territory. Furthermore,
Anesta, at its own cost and expense, shall be responsible for supplying its
Affiliates and Sub-Licensees and their investigators and trial sites with
suited materials to perform properly the Development Program.


 


12.3         Existing
Materials. ImmuPharma agrees to sell to Anesta and Cephalon
agrees to purchase from ImmuPharma the API Controlled by ImmuPharma which were
designated to be used in the Development Program and are still existing at the
Effective Date hereof. ImmuPharma agrees to sell such materials including
technical and quality control documentation according to Good Manufacturing
Practices, provided the API meets the Specifications and all other reasonable
quality control standards.  [**]


 


13.           Manufacturing Development


 


13.1         Responsibility.
[**]


 


13.2         Sub-Contracting.
For the avoidance of doubt, Anesta shall not use any sub-contractors to perform
such activities except in accordance with Clause 37.3.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


21

















 


14.           Manufacture of Licensed Products by Anesta; Manufacture by ImmuPharma


 


14.1         Manufacturing
Supply. Subject to Clause 16, Anesta shall by itself or
through its Affiliates, Anesta Sub-Licensees or permitted sub-contractors under
Clause 14.3 manufacture Finished Goods for sale by Anesta, its Affiliates,
Anesta Sub-Licensees and co-promoters (as defined in Clause 3.4) in all
countries of the Territory.  To the
extent requested by Anesta, ImmuPharma shall use Commercially Reasonable
Efforts to facilitate Anesta’s efforts to obtain supply of the Licensed
Molecules or Licensed Product from ImmuPharma’s current supplier.


 


14.2         Manufacturing
Data. In order to enable Anesta to make Finished Goods
for use as permitted under Clause 3, ImmuPharma shall itself, and shall use all
Commercially Reasonable Efforts to cause its relevant suppliers and contract
manufacturer(s) to, cooperate and assist in the transfer to Anesta of the
relevant Manufacturing Data and techniques generated by ImmuPharma, such
suppliers and contractors, to the extent that ImmuPharma has in its possession
and/or has the right to cause its relevant suppliers and contract manufacturer(s) to
transfer such Manufacturing Data and techniques at ImmuPharma’s cost and
expense.


 


14.3         Manufacturing
Undertakings. Anesta shall be responsible to ensure that
for the Finished Goods: (i) all manufacturing activities are performed in
accordance with all applicable laws, regulations, guidelines and standards,
including applicable current Good Manufacturing Practice; (ii) all
manufacturing activities are performed in facilities approved by the applicable
Regulatory Authorities; (iii) all Finished Goods conform to the applicable
Specifications; (iv) it informs ImmuPharma of any inspection, the making
of observations or other action by any Regulatory Authority that concerns such
manufacturing activities, provide copies of any
relevant documentation and correspondence and use all Commercially Reasonable
Efforts to enable ImmuPharma to comment on any response.  In the event that (a) a material lawsuit
or legal proceeding is instituted against Anesta or ImmuPharma that alleges a
significant manufacturing defect and (b) ImmuPharma provides thirty (30)
days prior written notice to Anesta of its desire to perform an inspection and
the grounds for such inspection, ImmuPharma may, at a mutually agreeable time,
inspect such manufacturing activities during normal business hours for a
reasonable amount of time.  Unless
required by law, ImmuPharma shall not disclose in any manner its observations
or any documentation resulting from its inspection, without the prior written
consent of Anesta.


 


14.4         Manufacture
by ImmuPharma.  [**]


 


15.           Obtaining and Maintaining NDAs for Licensed Product


 


15.1         Responsibility.
Anesta shall only be required to apply for NDAs in the Main Countries and in
those countries where it determines in its reasonable discretion to develop and
commercialize the Licensed Products.  For
the avoidance of doubt, Anesta shall be entitled to determine not to apply for
NDAs in any Main Country and such determination shall not be a breach of this
Agreement by Anesta.  To the extent an
exclusive license in a country where Anesta is not developing or commercializing
the Licensed Product is a violation of a limitation of the applicable antitrust
act or competition law or regulation for such country, Clause 33.5 shall apply.
Anesta, by itself or through its Affiliates or Anesta Sub-Licensees, shall have
sole responsibility for applying for, updating and maintaining all NDAs within
any countries of the Territory, in particular in all Main Countries, and for
ensuring that all requirements and conditions imposed upon it as holder of such
NDAs are complied with therein. However, at the reasonable request and cost of
Anesta, ImmuPharma shall provide reasonable assistance and cooperation in
connection with such activities in relation to providing Technical Information
requested by Anesta which is in ImmuPharma’s possession and at its free
disposal and procuring that its staff, where necessary, attend regulatory
hearings and are 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


22

















 


reasonably
available to discuss matters specific to the Licensed Molecules or Licensed
Product. It is understood, however, that ImmuPharma shall not be obliged to
provide general advice on regulatory matters. Anesta agrees to reimburse
ImmuPharma and/or its Affiliates, and sub-contractors for all their costs and
expenses, including, without limitation, all costs of materials, active
ingredients and excipients, package, delivery and transport, including the fair
and proportional allocation of overhead costs of its own personnel, in respect
of such assistance consistent with applicable IFRS.


 


15.2         Regulatory
Action. In the event that any Regulatory Authority
suspends or withdraws an NDA or orders withdrawal or recall of any Finished
Goods, or threatens such suspension, withdrawal or recall, Anesta shall
immediately inform ImmuPharma by telephone and in writing. The respective senior
management of the Parties shall thereafter discuss with each other in good
faith with appropriate urgency what further actions should be taken.


 


16.           Cooperation in Marketing


 


ImmuPharma shall be informed
through the Lupuzor Committee of Anesta’s, its Affiliates’, Anesta
Sub-Licensees’ and Co-promoters’ activities and plans intended to support and
exploit the commercial potential and medical acceptability of the Licensed
Molecules or Licensed Product on matters such as:


 


16.1         Commercialization.
The exchange of information concerning progress in commercialization of
Licensed Products by the Parties, including the progress and status of NDAs and
launching on and progress in the market;


 


16.2         Business
Strategy. The exchange of information concerning promotional
strategy and product and advertising literature for Licensed Products or
Licensed Molecules;


 


16.3         Overall
Strategy. The exchange of information regarding
non-promotional strategies and initiatives concerning Licensed Products or
Licensed Molecules (e.g. provision of scientific information; provision of
educational grants); and


 


16.4         Development.
(Without prejudice to Clauses 11 or 12) plans for Pre-Clinical Studies and
Clinical Studies and other aspects of the Development Program which are
intended to support and maximise the commercial potential and medical
acceptability of Licensed Products or Licensed Molecules.


 


17.           Marketing of Finished Goods


 


17.1         Branding.
Anesta shall market Finished Goods pursuant to the terms and conditions of the
Trademark License Agreement.


 


17.2         [**]


 


17.3         Marking.
Anesta shall, if practicable, legibly mark or have marked the Finished Goods
any associated packaging with the relevant patent or application numbers, in
each case to the extent permitted by applicable law or the applicable
Regulatory Authorities.


 


17.4         License Disclosure.
Anesta agrees and undertakes to print or have printed on the Finished Goods
package insert the following wording: “Product under license from ImmuPharma
(France) S.A. and ImmuPharma AG, Switzerland” or any other legally accepted
similar wording having the same basic meaning.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


23

















 


18.           General Diligence of Anesta


 


18.1         Commercialization. During the term of this Agreement, Anesta or its Affiliates
shall use Commercially Reasonable Efforts to (i) develop and promote the
distribution and sale of Licensed Products or Licensed Molecules in the Main
Countries and (ii) seek to maximise the commercial return from Licensed
Products or Licensed Molecules for the treatment of Lupus within the Territory
as a whole whereby Clauses 15.1 and 33.5 remain reserved.  For the avoidance of doubt, [**]


 


18.2         [**]


 


18.3         [**]


 


19.           Adverse Event Reporting; Suspension and Withdrawal of Products


 


19.1         The Parties shall meet within thirty (30)
days from the date of this Agreement to negotiate in good faith and agree on a
process and procedure for sharing adverse event information which shall be
documented in a pharmacovigilance agreement. Also, upon execution of this
Agreement, each Party shall assign a representative to ensure such a
pharmacovigilance agreement is adopted within one hundred and eighty (180) days
from the date of this Agreement.  Pending adoption of such agreement, the
parties shall, as soon as practicable, and in any event within thirty (30) days
implement a transition plan for exchange of any and all information concerning
adverse events related to use of the Licensed Molecules or Licensed Product
regardless of source, and the Parties shall ensure compliance with legal
requirements in their respective territories.


 


20.           New Technical Information and Inventions


 


20.1         ImmuPharma
Right, Title and Interest and License. Subject to the
rights expressly granted herein, as between the Parties, ImmuPharma shall own
and retain all right, title and interest in and to the Licensed Patents, the
Licensed Technical Information and the Licensed Trademarks.


 


20.2         Anesta
Right, Title and Interest. Subject to the rights
expressly granted herein, as between the Parties as well as all other terms and
conditions hereof, Anesta shall own and retain all right, title and interest in
and to any and all new Technical Information and Manufacturing Data arising
from activities undertaken or funded by Anesta, its Affiliates, Sub-Licensees
or sub-contractors related to the Development Program, Pre-Clinical Studies and
Clinical Studies  (the “Anesta Technical
Information”).


 


20.3         ImmuPharma
Inventions. Subject to Clause 20.6 and subject to the
rights expressly granted herein, as between the Parties, all right, title and
interest in and to any Inventions, and any Patents arising therefrom, shall be
owned and retained by ImmuPharma if such Invention was made by ImmuPharma, its
Affiliates, Sub-Licensees or their contractors.


 


20.4         Anesta
Inventions. Subject to the rights expressly granted
herein, as between the Parties, all right, title and interest in and to any
Inventions, and any Patents arising therefrom, shall be owned and retained by
Anesta if such Invention was made by or on behalf of Anesta, its Affiliates,
Anesta Sub-Licensees or their contractors  (the “Anesta
Patents”).


 


20.5         Mutual
Information. To the extent that either ImmuPharma or
Anesta acquires any significant new Technical Information or makes any
Invention, including without limitation regarding the quality, efficacy or
safety of Licensed Products or Licensed Molecules, which is useful or necessary
to the 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


24

















 


development,
manufacture, importation, use or sale of the Licensed Molecules or Licensed
Product, the respective Party shall use all Commercially Reasonable Efforts to
provide the respective other Party with a single paper copy and, if available,
a single electronic copy of such Technical Information or Invention.


 


20.6         Licensed
Technical Information and Licensed Patents. Any new Patents
owned, co-owned or Controlled by ImmuPharma  shall be added to
the term Licensed Patents and any new Technical Information owned, co-owned or
Controlled by ImmuPharma shall be added to the term Licensed Technical
Information. The use by Anesta, its Affiliates, Anesta Sub-Licensees or
permitted sub-contractors of such new Technical Information and new Licensed
Patents shall be subject to the same terms and conditions as the use of
Licensed Patents under this Agreement, including but not limited to the
confidentiality obligations contained herein.


 


20.7         Assignment
of Third Party Rights. Each Party shall ensure
that it, its Affiliates and its Sub-Licensees, to the fullest extent permitted
by any applicable law, own and retain or otherwise have access to all right,
title and interest in and to any and all Technical Information and Inventions
generated by their employees, agents, directors and contractors and any and all
Inventions made by their employees, agents, directors and contractors and that
such Technical Information and Inventions are available to the respective other
Party for use, to the extent provided for, and 
in accordance with the terms and conditions of this Agreement at no
extra cost or expense for the receiving Party other than that provided for by
the terms and conditions of this Agreement.


 


20.8         License to Use.
Subject to Clauses 20.2 and 20.4, each Party shall ensure that it has
sufficient right, title and interest in and to all Patents, Inventions and
Technical Information newly acquired by it or its Affiliates to enable such
Party to make such Patents, Inventions and Technical Information available for
use by the respective other Party, its Affiliates and Sub-Licensees to the
extent they relate to the Licensed Molecules or Licensed Product in accordance
with the terms and conditions of this Agreement provided that each Party
accepts that the use by such receiving Party, its Affiliates or Sub-Licensees
of such Patents, Inventions and Technical Information relating to the Licensed
Molecules or Licensed Product may be subject to the receiving Party’s giving of
an undertaking, also on behalf of its Affiliates and Sub-Contractors to the
other Party to maintain the confidentiality of such newly acquired Patents,
Inventions and Technical Information.


 


20.9         Third
Party Agreements. ImmuPharma and its
Affiliates shall avoid entering into agreements with Independent Third Parties
except CNRS for the generation or acquisition of new Technical Information or
Inventions or Patents to the extent such new Technical Information, Inventions
or Patents relate to the Licensed Molecules or Licensed Product without the
prior written consent of Anesta, which consent shall not be unreasonably
withheld and shall be deemed to be given for all agreements of ImmuPharma with
CNRS..


 


20.10       Preservation
of Rights.  ImmuPharma
shall (i) preserve and not encumber or diminish its rights under the CNRS
Agreements and any other agreements pursuant to which it has rights to the Licensed
Patents, Licensed Technical Information or the Licensed Trademarks, (ii) provide
prompt written notice of any alleged breach of any such agreement, (iii) not
breach the CNRS Agreements, (iv) not amend the CNRS Agreements after the
Effective Date, without the prior written consent of Anesta, other than the
amendments set forth in Section 5 to the Option Agreement and (v) to
the extent ImmuPharma does not obtain the amendment to the CNRS License
Agreement prior to this Agreement becoming effective, use Commercially
Reasonable Efforts to agree with CNRS materially on the amendments to the CNRS
License Agreement set forth in Schedule 5 to the Option Agreement.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an application
for confidential treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


25

















 


21.           Patent Protection for Inventions


 


21.1         Registration
by Anesta. Anesta and its Affiliates retain the right, but
not the obligation, in their sole and absolute discretion, to prepare, file,
prosecute, maintain and extend the Patents, arising from Inventions that belong
to Anesta or its Affiliates under Clauses 20.2, 20.3 and 20.4 on the terms and
conditions hereof.  ImmuPharma shall use
all Commercially Reasonable Efforts to cooperate with Anesta in Anesta’s
filing, prosecution, maintenance and extensions of such Patents.


 


22.           Prosecution of the Licensed Patents and Approval Information


 


22.1         Filing.
Anesta shall, at its cost and expense and through patent attorneys or agents of
its choice, be primarily responsible for preparing, filing, prosecuting,
maintaining and extending, for their full term, the CNRS Lupuzor Patents in the
Territory and ImmuPharma shall at its cost and expense and through patent
attorneys or agents of its choice be primarily responsible for for preparing,
filing, prosecuting, maintaining and extending, for their full term, the
ImmuPharma Patents in the Territory.  The
Parties shall agree on a common strategy with respect to the preparation,
filing, prosecution, maintenence and extension of, for their full term, the
Licensed Patents.  At Anesta’s request,
ImmuPharma shall assist Anesta, cooperate and be joined and named in any
action, at Anesta’s cost and expense, and at Anesta’s request, ImmuPharma shall
use commercially reasonable efforts to cause CNRS to assist, cooperate and be
joined and named in any such action, at Anesta’s cost and expense.


 


22.2         ImmuPharma
Consultation and Information. Each Party shall keep the
other Party informed of all significant steps taken in prosecution in the
Territory of all the Licensed Patents. Each Party shall furnish the other Party
with copies of applications for the Licensed Patents, amendments thereto and
other related significant correspondence to and from patent offices within the
Territory to allow for review by and consultation with the other Party
reasonably in advance of any submission to a patent office which could
materially affect the scope or extent or validity of the Licensed Patents
within the Territory.  To the extent CNRS
is the party controlling the prosecution or taking significant steps in the
prosecution of the Licensed Patents in the Territory, ImmuPharma shall use
Commercially Reasonable Efforts to facilitate direct communication between
Cephalon and CNRS regarding the prosecution of the Licensed Patents.


 


22.3         Anesta
Information. Anesta shall furnish ImmuPharma a copy of
every NDA in the Territory in respect of all Licensed Products, a copy of the
notice publishing the authorisation in the appropriate official publication in
the relevant jurisdiction as well as a copy of any additional information and
documents necessary to fulfil any additional requirements imposed by relevant
national law in relation to Patent Term Extensions.


 


23.           Infringement of the Licensed Rights


 


23.1         Suing
Rights. In the event that either ImmuPharma or Anesta
become aware of actual or threatened infringement of a Licensed Patent anywhere
in the Territory, that Party shall promptly notify the other Party in writing.
In such an event, Anesta and ImmuPharma shall consult each other to develop a
common strategy as to whether or not to bring an action regarding the
infringement, and which Party shall bring such an action, taking into
consideration the interest of Anesta in maximizing its commercial return from
the Licensed Products and Licensed Molecules. In the event that Anesta and
ImmuPharma agree to bring an action, Anesta shall have the first right but not
the obligation to bring, at its own expense, such an infringement action
against any Third Party and shall have the right to join ImmuPharma to such
action and to name them as parties in such action. If, ImmuPharma, and Anesta
agree that it is desirable that ImmuPharma bring an infringement action against
any Third Party it shall have the right to join Anesta or its Affiliates as a
party to 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


26

















 


such action and
to name them in such action. Anesta shall have full control over the conduct of
such action brought by Anesta, even if ImmuPharma is joined with Anesta in such
action, and ImmuPharma shall have full control over the conduct of any action brought
by ImmuPharma.[**]  In the event that
Anesta and ImmuPharma cannot agree as to whether or not to bring an combined
action regarding the infringement, each Party shall have the right to decide
whether or not to bring an infringement action and such action shall be brought
at that Party’s sole cost and expense. In any event, (i) at Anesta’s
request, ImmuPharma shall assist Anesta, cooperate and be joined and named in
any such action at Anesta’s cost and expense, (ii) at Anesta’s request,
ImmuPharma shall use commercially reasonable efforts to cause CNRS to assist,
cooperate and be joined and named in any such action at Anesta’s cost and
expense and (iii) at ImmuPharma’s request, Anesta shall assist ImmuPharma,
cooperate and be joined and named in any such action at ImmuPharma’s cost and
expense. To the extent CNRS is the party that brings the suit or action,
ImmuPharma shall use Commercially Reasonable Efforts to provide Cephalon with
access to CNRS, including the facilitation of direct communication with CNRS
regarding such suit or action. All amounts recovered in such action shall be
used first for payment of Anesta’s and ImmuPharma’s cost and expenses in
conducting such action. All other amounts recovered in any such infringement
action will be allocated exclusively to the suing Party or, if Anesta has been
assisted by ImmuPharma, or if ImmuPharma has been assisted by Anesta, then [**]


 


23.2         Mutual
Information. Anesta and ImmuPharma shall keep each other
informed of material events of any litigation or settlement thereof concerning
Licensed Products or Licensed Molecules. Each Party shall keep the other Party
informed of any actual or threatened infringement of a Licensed Patent.


 


23.3         Applicability.
All terms and conditions of this Clause 23 shall apply mutatis mutandis
in relation to:


 


(A)          any
infringements of the Licensed Trademarks; and


 


(B)           any
non-authorised use of the Licensed Technical Information.


 


24.           Infringement of Independent Third Party Rights


 


24.1         Third
Party Claims. In the event of the institution of any suit
by an Independent Third Party against ImmuPharma, Anesta or any of their
Affiliates for infringement of patent or other proprietary rights involving the
manufacture, use, sale, distribution or marketing of Licensed Product or
Licensed Molecules anywhere in the Territory (such suit to be termed, for the
purposes of this Clause 24, a “Third Party Claim”), the Party sued shall
promptly notify the other Party in writing. The Party shall also promply
evaluate which, if any, technical alternative is possible to circumvent Third
Party Rights. ImmuPharma and Anesta shall assist one another and cooperate in
any such litigation at the other’s request without expense to the requesting
Party.


 


24.2         Cost
Sharing. If the Relevant Conditions (as specified in Clause
24.2(C)) are all satisfied, and if the Third Party Claim results in a
settlement with the Independent Third Party who is bringing the Third Party
Claim or in a final judgment with no realistic prospects for a successful
appeal that the Licensed Molecules themselves or the method of manufacturing
the Licensed Molecules infringes the relevant patent or other intellectual
property rights of such Independent Third Party, then:


 


(A)          the Parties shall share
equally in their combined reasonable legal costs and expenses incurred in the
defence against such Independent Third Party Claim and in any damages or other
amounts awarded against them or paid by way of settlement in respect of the
past infringement of such patent or other intellectual property rights of the
Independent Third Party.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


27

















 


(B)           in the event that such
settlement or final judgment allows Anesta to continue to sell the relevant
Licensed Molecules in the future subject to paying running royalties to such
Independent Third Party on such future sales of Licensed Molecules, Anesta
shall pay Running Royalties to ImmuPharma [**].


 


(C)           “Relevant Conditions”
are (a) the Third Party Claim must allege that making, using or selling
the Licensed Molecules or Licensed Product or the method of manufacturing
Licensed Product or Licensed Molecules infringes the relevant patent or other
intellectual property rights of the Independent Third Party who is bringing the
Third Party Claim; (b) the defence to the Third Party Claim will be
conducted by Anesta, but in consultation with ImmuPharma; (c) no
settlement is made relating to such Third Party Claim without ImmuPharma’s
written consent (not to be unreasonably withheld or delayed); and (d) no
license of the Licensed Patents shall be granted to such Independent Third
Party without ImmuPharma’s written consent, acting in ImmuPharma’s absolute
discretion.


 


24.3         Orders
and Injunctions. If at any stage a final or
temporary restraining order or interlocutory or interim injunction or similar
order of any competent court is granted whereby Anesta is restrained from
manufacturing, selling or otherwise dealing with Licensed Molecules in the
Territory then Anesta’s obligations to purchase, use, sell, distribute and
market such Licensed Molecules in such part of the Territory to which the said
order or injunction applies pursuant to this Agreement shall be suspended for
so long as such order or injunction applies whereby it is agreed and understood
that the terms and conditions of this Clause 24 shall mutatis mutandis also
apply in full thereto.


 


25.           Confidentiality


 


25.1         ImmuPharma
Confidential Information. Anesta undertakes to
ImmuPharma that it shall keep all Technical Information strictly confidential
and to make the Technical Information only available to such persons within
Anesta, its Affiliates, Anesta Sub-Licensees and any Third Party contractors
who have agreed to be bound by secrecy obligations no less restrictive than
those set forth herein in respect of such Technical Information as Anesta owes
to ImmuPharma hereunder, to their advisors and representatives and to such of
Anesta’s officers and employees as are bound by obligations of confidence and
on a “need to know” basis, and Anesta shall ensure that such Technical
Information is not disclosed to other persons or Entities orally or in writing,
directly or indirectly, by Anesta, any Anesta Affiliate, any Anesta
Sub-Licensee or any of said contractors or said officers and employees save
that:


 


(A)          this
obligation shall not apply to Anesta to the extent that the Technical
Information as evidenced by Anesta’s written records, was lawfully known to
Anesta prior to its communication by or through ImmuPharma and was not
communicated to Anesta subject to any restrictions on disclosure or use; and


 


(B)           this
obligation shall not apply to the extent that Technical Information is
necessarily disclosed by the sale of Licensed Products on the terms and
conditions hereof embodying any of the Technical Information; and


 


(C)           this
obligation shall not apply to the extent that the Technical Information is or
becomes in the public domain, otherwise than by any fault or breach by Anesta,
its Affiliates, Anesta Sub-Licensees or sub-contractors or other persons
acquiring the same from Anesta or any thereof; and


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


28

















 


(D)          this
obligation shall not apply to Anesta to the extent that the Technical
Information becomes known to Anesta by the action of a Third Party not in
breach of any obligation of confidence;


 


(E)           this
obligation shall not apply to the extent that such Technical Information must
be disclosed by law or by order of a court of competent jurisdiction or to
comply with the requirements of any securities exchange or to any governmental
or regulatory agency in connection with an application for an IND or NDA; and


 


(F)           this
obligation shall not apply to Anesta’s use of Technical Information made
available to it by or on behalf of ImmuPharma or its Affiliates for the
prosecution of patents, to make any regulatory filing or for publication of
results of Clinical Studies or otherwise related to the development or
commercialization of the Licensed Products or Licensed Molecules.


 


25.2         Anesta
Confidential Information. ImmuPharma undertakes to
Anesta that it shall keep all Technical Information strictly confidential and
to make the Technical Information only available to such persons within
ImmuPharma and its Affiliates, their advisors and representatives, and to any
Third Party contractors who have agreed to be bound by the same secrecy
obligations in respect of such Technical Information as ImmuPharma owes to
Anesta hereunder, and to such of ImmuPharma’s officers and employees as are
bound by obligations of confidence and on a “need to know” basis, and
ImmuPharma shall ensure that such Technical Information is not disclosed to
other persons or Entities orally or in writing, directly or indirectly, by
ImmuPharma, any ImmuPharma Affiliate, or any of said contractors or said
officers and employees save that:


 


(A)          this obligation shall not
apply to ImmuPharma to the extent that Technical Information owned by Anesta,
as evidenced by ImmuPharma’s written records, was lawfully known to ImmuPharma,
its Affiliates, or sub-contractors prior to its communication by or through
Anesta and was not communicated to ImmuPharma subject to any restrictions on
disclosure or use; and


 


(B)           this
obligation shall not apply to the extent that the Technical Information is
necessarily disclosed by the sale of Licensed Products embodying any of the
Technical Information; and


 


(C)           this
obligation shall not apply to the extent that the Technical Information is or
becomes in the public domain, otherwise than by any fault or breach by
ImmuPharma, its Affiliates, contractors, directors or agents, or persons
acquiring the same from ImmuPharma; and


 


(D)          this
obligation shall not apply to ImmuPharma to the extent that the Technical
Information owned by Anesta becomes known to ImmuPharma by the action of a
Third Party not in breach of any obligation of confidence;


 


(E)           this
obligation shall not apply to the extent that such Technical Information must
be disclosed by law or by order of a court of competent jurisdiction or to
comply with the requirements of any securities exchange or to any governmental
or regulatory agency in connection with an application for an IND or NDA.


 


25.3         Survival
and Applicability. The obligations of
confidentiality herein shall survive for as long as the confidential
information disclosed to the other Party hereunder remains confidential.  Such confidentiality obligation shall apply
to Technical Information and any other confidential information exchanged
between the Parties and their Affiliates both prior to and after entering into
this Agreement and, with respect to such Technical Information, replace any and
all previous 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


29

















 


confidentiality
obligations owed by either party or its Affiliates to the other or its
Affiliates (including without limitation under the Confidentiality Agreement).


 


26.           Public Announcements


 


26.1         This
Agreement. The Parties agree that the terms of this Agreement
shall, unless the Parties otherwise agree in writing, be treated as
confidential, subject to Clauses 26.2 and 26.3.


 


26.2         Press
Releases. With regard to press releases and other
announcements about the Licensed Molecules or Licensed Product (including with
regard to development progress), it is the Parties’ intent that they shall
co-ordinate with respect to the wording and timing of any such announcements.
Each Party shall use its best endeavours to give the other Party a draft of
each such announcement at least two (2) Business Days in advance of its
planned release and thereafter keep the other Party promptly informed of any changes
to such draft, and shall consider in good faith any reasonable comments made on
such draft(s) by such other Party.


 


26.3         Listing
and other Required Publicity. Nothing contained in this
Agreement shall prevent either Party from disclosing such information as is
required to be disclosed by law or regulatory requirement including without
limiting the generality of the foregoing the regulation of any Stock Exchange
on which the shares or other securities of such Party or its Affiliates or
Sub-Licensees are quoted or listed.  For
the avoidance of doubt, if either Party or its Affiliates or Sub-Licensees are
required by such laws or regulatory requirements or by any regulatory body to
make an immediate disclosure of any information, they shall be entitled to do
so.


 


27.           ImmuPharma Representations and Warranties


 


27.1         Representations
and Warranties. ImmuPharma represents and warrants that, as
of the Effective Date hereof:


 


(A)          ImmuPharma is validly
existing under the laws of France, with full power and authority to execute and
deliver this Agreement and perform its obligations hereunder;


 


(B)          ImmuPharma is not insolvent;


 


(C)          ImmuPharma has the corporate
power to execute, deliver and enter into and perform this Agreement and has
been duly authorized by all necessary or proper corporate action to do so;


 


(D)          this Agreement has been duly
executed by ImmuPharma and represents a legal, valid and binding obligation of
ImmuPharma, enforceable in accordance with its terms;


 


(E)           ImmuPharma’s execution and
performance of this Agreement do not conflict with, violate or breach (i) its
applicable entity formation documents, (ii) any contractual obligations
with any Third Party or (iii) any law or regulation, and no consent is
required from any Third Party (including CNRS) or governmental authority for
ImmuPharma to execute and perform its obligations in this Agreement, except for
the consent required under section 3.1 of the CNRS License Agreement, which
consent has been delivered to Anesta prior to the Effective Date and except for
(x) the expiration of the waiting period under the Hart-Scott-Rodino
Act, if applicable or (y) any other applicable antitrust regulations or
any other antitrust regulations anywhere in the Territory, to the extent such
acts or regulations are applicable hereto or to the Signed Agreements;


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


30
















 


(F)           ImmuPharma has not received
notice and does not have knowledge of any fact which alleges  or threatens any challenge to the rights of
ImmuPharma, its Affiliates or Anesta or its Affiliates, or is likely to prevent
Anesta or its Affiliates from developing, making, using, importing or selling
the Licensed Molecules in the Territory on the terms and conditions hereof;


 


(G)          ImmuPharma has not received
notice and does not have knowledge of any fact which is likely to prevent
ImmuPharma from performing any obligation of ImmuPharma under this Agreement on
the terms and conditions hereof;


 


(H)          Schedule 2 attached
hereto sets forth a true and accurate list of all Patents owned, co-owned,
licensed, or Controlled by ImmuPharma or to which it otherwise has rights, which
relate to the development, manufacture, use, sale or commercialization of the
Licensed Molecules, or Licensed Product;


 


(I)            ImmuPharma is the exclusive licensee
of the Third Party Patents, including but not limited to the CNRS Lupuzor
Patents, and the Third Party Technical Information, except for CNRS’s right to
make and use the CNRS Lupuzor Patents and the CNRS Technical Information for
non-commercial research purposes as provided for in the CNRS/ImmuPharma License
Agreement, ImmuPharma has the right to grant the rights and licenses (or
sub-licenses, where applicable) to the CNRS Lupuzor Patents, ImmuPharma
Patents, ImmuPharma Technical Information, Third Party Technical Information,
the Licensed Products and the Licensed Molecules to Anesta as set forth in this
Agreement;


 


(J)           ImmuPharma is the owner or
co-owner of the ImmuPharma Patents and the ImmuPharma Technical Information,
free and clear of any lien, encumbrance or security interest and to the
best knowledge of ImmuPharma, the Third Party Patents and Third Party Technical
Information are free and clear of any lien, encumbrance or security interest;


 


(K)          there is no pending or, to
the knowledge of ImmuPharma, threatened litigation, claim, investigation,
action or proceeding that could impair the ability of ImmuPharma to perform its
obligations under this Agreement or the License Agreements or which would
affect the validity, enforceability or ownership of the Licensed Patents or
Licensed Technical Information;


 


(L)           Schedule 4 is
a listing of all material agreements, including but not limited to agreements
with CNRS entered into by ImmuPharma related to the Licensed Patents, Licensed
Product, Licensed Molecules or Licensed Technical Information. Accurate and
complete copies of such agreements have been delivered to Anesta or its
Affiliates prior to the Effective Date. As of the date hereof, neither
ImmuPharma, nor to the knowledge of ImmuPharma, any other party to such
agreements is in material breach of any agreements;


 


(M)         to the best of ImmuPharma’s
knowledge, the inception, development and reduction to practice of the
ImmuPharma Patents and the ImmuPharma Technical Information has not and does
not constitute and has not involved the misappropriation of trade secrets of
any Third Party;


 


(N)          to the best of ImmuPharma’s
knowledge, none of the Licensed Patents is invalid or unenforceable and no
claim has been received by ImmuPharma, or to the knowledge of ImmuPharma
received by CNRS, asserting the invalidity, misuse, unregistrability,
unenforceability or non-infringement of any of the Licensed Patents or
challenging its right 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


31

















 


to use or ownership of any of the Licensed Patents or making any adverse
claim of ownership thereof;


 


(O)          ImmuPharma has delivered to Cephalon
a true and complete copy of the FDA IND file on pre-clinical and clinical data
and other information in ImmuPharma’s Control which could reasonably be
considered material for the safety or efficacy of the Licensed Molecules or
Licensed Product and to the best of ImmuPharma’s knowledge such pre-clinical
and clinical data and studies are in material compliance with all rules,
regulations and laws, except for those pre-clinical studies that did not comply
with GMP rules and regulations which ImmuPharma has disclosed to Cephalon
in writing;


 


(P)           ImmuPharma is not aware of
any patent or patents affecting the validity of the Licensed Patents or any
novelty destroying prior art relating to the Licensed Patents;


 


(Q)          ImmuPharma has received the
written agreement of CNRS required under Clause 3.1 of the CNRS Agreement
and has delivered a copy of such agreement to Cephalon;


 


(R)          ImmuPharma is not in breach
of the CNRS Agreement and no rights of ImmuPharma provided for in the CNRS
Agreement have been modified in any way to have adverse effects on this
Agreement; and


 


(S)           ImmuPharma is not aware of any
patents or patents applications other than the Licensed Patents for which a
claim of infringement could reasonably be asserted for the development, manufacture,
use, sale or commercialization of the Licensed Molecules or Licensed Product.


 


28.           Anesta Representations and Warranties


 


28.1         Representations
and Warranties. Anesta represents and warrants that, as of
the Effective Date hereof:


 


(A)          Anesta is validly existing
under the laws of Switzerland, with full power and authority to execute and
deliver this Agreement and perform its obligations hereunder;


 


(B)          Anesta has the corporate
power to execute, deliver and enter into and perform this Agreement and has
been duly authorized by all necessary or proper corporate action to do so;


 


(C)          this Agreement has been duly
executed by Anesta and represents a legal, valid and binding obligation of
Anesta, enforceable in accordance with its terms;


 


(D)          Anesta’s execution and
performance of this Agreement do not conflict with, violate or breach (i) its
applicable entity formation documents, (ii) any contractual obligations
with any Third Party or (iii) any law or regulation, and no consent is
required from any Third Party or governmental authority for Anesta to execute
and perform the obligations in this Agreement; except for (x) the
expiration of the waiting period under the Hart-Scott-Rodino Act, if applicable
or (y) any other applicable antitrust act or regulation, to the extent
such antitrust acts or regulations are applicable hereto or to any of the
Signed Agreements anywhere in the Territory;


 


(E)           there is no material fact
which is likely to prevent Anesta from developing, making, using, importing and
selling the Licensed Molecules or Licensed Product in the Territory;


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


32

















 


(F)           Anesta has not received
written notice or does not have knowledge of any fact which is likely to
prevent Anesta from performing any obligation of Anesta under this Agreement;


 


(G)          Anesta has not received any
written notice from any third party which alleges or threatens any challenge to
the right of Anesta to develop, make, have made, import, use and sell the
Licensed Molecules or Licensed Product in the Territory under the Licensed
Patents;


 


(H)          Anesta has the commercial,
technical and financial resources and expertise available, and intends to use
them, to develop, manufacture, import, use and sell Licensed Products or
Licensed Molecules in the Territory as contemplated by this Agreement.


 


(I)            Cephalon, as guarantor under
the Parent Guarantee Agreement, is validly existing under the laws of the
United States of America, with full power and authority to execute and deliver
the Partent Guarantee Agreement and perform its obligations hereunder;


 


(J)           Cephalon has the corporate
power to execute, deliver and enter into and perform the Parent Guarantee
Agreement and has been duly authorized by all necessary or proper corporate
action to do so;


 


(K)          the Parent Guarantee
Agreement has been duly executed by Cephalon and represents a legal, valid and
binding obligation of Cephalon, enforceable in accordance with its terms; and


 


(L)           Cephalon’s execution and
performance of the Parent Guarantee Agreement does not conflict with, violate
or breach (i) its applicable entity formation documents, (ii) any
contractual obligations with any Third Party or (iii) any law or
regulation, and no consent is required from any Third Party or Governmental
Authority for Cephalon to execute and perform the obligations in the Partent
Guarantee Agreement.


 


29.           Indemnification between the Parties


 


29.1         By
ImmuPharma. ImmuPharma shall indemnify, protect and
hold Anesta and its Affiliates harmless against any claims, demands, suits or
causes of action asserted or brought by Independent Third Parties, including
all judgments, damages and costs (including reasonable attorney’s fees)
resulting therefrom, at any time arising from:


 


(A)          any failure by ImmuPharma to
provide Anesta with significant information or data in its possession regarding
the safety of Licensed Molecules or Licensed Product to the extent that such
information or data were not already known by Anesta;


 


(B)           with respect to Finished
Goods manufactured by or on behalf of ImmuPharma pursuant to Clause 33.5,
manufacturing defects which are manufactured by or on behalf of ImmuPharma, its
Affiliates or any permitted sub-licensees, sub-contractors or any other Third
Parties acting on behalf of ImmuPharma;


 


(C)           ImmuPharma’s or its
Affiliates’ or ImmuPharma’s subcontractors or any other parties acting on
behalf of ImmuPharma gross negligence or breach of the terms of this Agreement;
or


 


(D)          any breach of ImmuPharma’s
representations and warranties in this Agreement;


 


whereby ImmuPharma shall
only have an obligation to so indemnify and hold harmless to the extent that
such liability, damages, loss, cost or expense do not arise from the
negligence, wilful misconduct or breach of this Agreement by Anesta, its
Affiliates, its Anesta Sub-Licensees or by 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


33

















 


any other Third Party
acting on behalf of Anesta.


 


29.2         By
Anesta. Anesta shall indemnify, protect and hold
ImmuPharma and its Affiliates harmless against any claims, demands, suits or
causes of action asserted or brought by Independent Third Parties, including
all judgments, damages and costs (including reasonable attorney’s fees)
resulting therefrom, at any time arising from:


 


(A)          manufacturing defects of
Finished Goods which are manufactured by or on behalf of Anesta, its
Affiliates, Anesta Sub-Licensees or any permitted sub-contractors or any other
Third Parties acting on behalf of Anesta;


 


(B)           Anesta’s or its Affiliates’,
Anesta’s Sub-Licensees or any permitted sub-contractors or any other Third
Parties acting on behalf of Anesta gross negligence or breach of the terms of
this Agreement; or


 


(C)           any breach of Anesta’s
representations and warranties in this Agreement;


 


whereby Anesta shall only
have an obligation to so indemnify and hold ImmuPharma harmless to the extent
that such liability, damages, loss, cost or expense do not arise from the
negligence, wilful misconduct or breach of this Agreement by ImmuPharma or
ImmuPharma’s Affiliates or ImmuPharma’s subcontractors or any other parties
acting on behalf of ImmuPharma by any other party acting on behalf of
ImmuPharma.


 


29.3         Notifications.
Each Party shall give prompt notification to the other of any claims, demands,
suits or causes of action in respect of which the first Party may assert
indemnification from the other under this Clause 29. The indemnifying Party
shall have the right, at its own cost, to defend any such claim, demand, suit
or cause of action. The indemnified Party shall have the right to be
represented by separate counsel, at its own expense, in any such claim, demand,
suit or cause of action. The indemnifying Party shall have control over any
such claim, demand, suit or cause of action and any decisions as to settlement,
method and/or terms and conditions for resolving the same shall be made by the
indemnifying Party after consultation with the other Party.


 


29.4         Assistance.
The indemnified Party agrees to perform all acts that may become reasonably
necessary or desirable, as determined by the indemnifying Party for the defence
and/or settlement of any such claim, demand, suit or cause of action.  The indemnifying Party shall reimburse the
other Party for its reasonable out-of-pocket expenses related thereto.


 


29.5         Joint
Liability. If both Clause 29.1 and Clause 29.2 apply in
respect to the same claim, demand, suit or cause of action, then ImmuPharma and
Anesta shall be liable to indemnify each other in such ratio as is fair and
reasonable, taking into account the contribution that the factors referred to
in Clauses 29.1(A) to
(C) and Clauses 29.2(A) to (B) have respectively given rise to
such claim, demand, suit or cause of action. 
Such ratio shall be agreed between the Parties and, if not agreed,
determined using the dispute resolution procedure given in Clause 39.


 


30.           Insurance


 


From the date on which this
Agreement becomes effective until 730 (seven hundred and thirty) calendar days
after all Running Royalties or other running royalties-bearing licenses granted
under this Agreement have expired or terminated on the terms and conditions
hereof and, each Party shall at its own cost effect and maintain in force with
reputable insurers appropriate insurance that are commercially customary in the
pharmaceutical industry in each country of the Territory where an activity is
undertaken by a Party (including without limitation, where appropriate, product
liability) 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


34

















 


in respect of its activities
concerning Licensed Products or Licensed Molecules in the Territory and shall
provide evidence of such insurance to the other Party on request.


 


31.           Disclaimer


 


31.1         EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT AND TO THE FULLEST EXTENT PERMITTED BY
LAW:


 


(A)          IMMUPHARMA MAKES NO WARRANTY
OR REPRESENTATION AS TO THE SCOPE OF THE LICENSED PATENTS OR THE LICENSED
TECHNICAL INFORMATION;


 


(B)           IMMUPHARMA MAKES NO WARRANTY
OR REPRESENTATION THAT USE OF THE LICENSED PATENTS OR THE LICENSED TECHNICAL
INFORMATION OR THE LICENSED TRADEMARKS WILL NOT CAUSE HARM OR DAMAGE TO ANY
INDIVIDUAL, ENTITY OR PROPERTY;


 


(C)           IMMUPHARMA IS NOT LIABLE OR
RESPONSIBLE FOR ANY AND ALL LIABILITY, INCLUDING DEATH, PERSONAL INJURY,
ILLNESS OR PROPERTY DAMAGE ARISING FROM PRE-CLINICAL STUDIES, CLINICAL TRIALS,
DISTRIBUTION OR SALE BY ANESTA, ITS AFFILIATES OR ANESTA SUB-LICENSEES OF ANY
GOODS, LICENSED PRODUCTS OR LICENSED MOLECULES;


 


(D)          ANESTA IS NOT LIABLE OR
RESPONSIBLE FOR ANY AND ALL LIABILITY, INCLUDING DEATH, PERSONAL INJURY,
ILLNESS OR PROPERTY DAMAGE ARISING FROM PRE-CLINICAL STUDIES, CLINICAL TRIALS,
DISTRIBUTION OR SALE UNDERTAKEN BY IMMUPHARMA, ITS AFFILIATES OR IMMUPHARMA
SUB-LICENSEES OF ANY GOODS, LICENSED PRODUCTS OR LICENSED MOLECULES;


 


(E)           NEITHER PARTY MAKES ANY
GOODS OR LICENSED PRODUCT WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR SATISFACTORY QUALITY OR FITNESS FOR A PARTICULAR PURPOSE;


 


(F)           NEITHER PARTY MAKES ANY
REPRESENTATIONS OR GIVES ANY WARRANTIES THAT ANY GOODS OR LICENSED PRODUCTS
WILL SUCCESSFULLY BE DEVELOPED USING THE LICENSED PATENTS OR LICENSED TECHNICAL
INFORMATION, OR THAT ANY LICENSED PRODUCTS WILL HAVE COMMERCIAL UTILITY OR
REGULATORY ACCEPTABILITY OR MERCHANTABILITY OR SATISFACTORY QUALITY OR FITNESS
FOR A PARTICULAR PURPOSE; AND


 


(G)           NEITHER PARTY MAKES ANY
OTHER REPRESENTATIONS OR GIVES ANY OTHER WARRANTIES OF ANY KIND, WHETHER
EXPRESS OR IMPLIED.


 


32.           Ordinary Termination


 


32.1         Ordinary
Termination. Subject to the terms of this Agreement, the
entire Agreement shall, on a country by country and patent by patent basis,
continue until the last to occur of:


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


35

















 


(A)          the date of expiry of the
last to expire of the Licensed Patents, which provide marketing exclusivity for
the Licensed Products, in such country of the Territory; or


 


(B)           the fifteenth anniversary of
the First Commercial Sale in such country of the Territory;


 


whichever of (A) or (B) is
longer in such country of the Territory  (the “Ordinary Termination”).


 


32.2         Consequences
of Ordinary Termination. Upon expiry of this
Agreement in any country of the Territory in accordance with Clause 32.1 (A) and
(B) (but not, for the avoidance of doubt, upon any earlier termination of
this Agreement under Clause 33 prior thereto unless otherwise expressly stated
in this Agreement):


 


(A)          Anesta
and its Affiliates shall have a perpetual, fully paid-up, royalty-free,
irrevocable right to use in such country of the Territory the Licensed
Technical Information, the Licensed Patents and any Inventions comprised
therein for the development, commercialization and exploitation of Licensed
Products; and


 


(B)           Anesta
shall be entitled to continue to use any Licensed Trademarks in the Territory
in respect of Licensed Products or Licensed Molecules in accordance with the
Trademark License Agreement, [**] which are marketed using such Licensed
Trademarks, provided however that no such Running Royalties shall be paid if
there is Significant Generic Competition (as defined) in the United States in
that Commercial Year on the terms and conditions of Clause 6.2 hereof. In respect
of the payment of such Running Royalties the payment provisions contained in
the Trademark Agreement shall continue to apply.


 


(C)           Where
the Parties disagree over the level of any Running Royalties payable pursuant
to this Clause 32.2, the matter shall be referred to the Oversight Committee.


 


32.3         Survival
Upon Ordinary Termination. Upon Ordinary Termination
and expiry of this Agreement in accordance with Clause 32.1 in any country
of the Territory (but not, for the avoidance of doubt, upon any earlier
termination of this Agreement unless otherwise expressly stated in this
Agreement), the following Clauses and Sections shall survive expiry and the
Parties shall continue to be bound by them:


 


(A)          This Agreement In General.
Clauses 1, 8.1, 8.3, 8.4 (to the extent applicable for Accounting Periods
elapsed in full or in part during the term hereof in such country), 9 and 10
(both of 9 and
10 to the extent applicable for Accounting Periods elapsed in full or in part
in such country during the term hereof), 11.6, Clauses 20.2 to 20.6, 22.2, 22.3, 25, 29 to 31, 32.2, 32.3, 32.4
as well as 37 and 39 to 50 of this Agreement; and, in addition,


 


32.4         The
expiry of this Agreement shall:


 


(A)          be without prejudice to the
obligation of Anesta to pay to ImmuPharma all Commercial and Development
Milestones, Running Royalties and other sums accrued, due and payable prior to
the expiry of this Agreement therein or thereafter, pursuant to Clause 32.2(B) on
the terms and conditions hereof; and


 


(B)           be without prejudice to any
right of, or remedy available to, either Party against the other in respect of
any breach of this Agreement prior to the effective date of such expiry in such
country, but otherwise neither Party shall be entitled to compensation on such
expiry, except as expressly stated in this Agreement.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


36

















 


33.           Specific Performance and Extraordinary Termination


 


33.1         Specific Performance. The Parties agree that this Development and Commercialization
Agreements represent unique property that cannot be readily obtained on the
open market and each Party may be irreparably injured if this Agreement is not
specifically enforced after the breach or default by the other Party.
Therefore, the other Party shall also have the right to specifically enforce
the other Party’s performance of its obligations under this Agreement, and each
Party agrees to waive the defense in any such suit that the other Party has an
adequate remedy at law and to interpose no opposition, legal or otherwise, as
to the propriety of specific performance as a remedy, and that the other Party
shall have the right to obtain specific performance of the terms of this
Agreement without being required to prove actual damages.


 


33.2         Breach
of Agreement. In the event that either Party commits a
material breach of any of the other terms of this Agreement on its part to be
performed or observed, the other Party shall have the right to terminate this
Agreement by giving one hundred twenty (120) calendar days’ written notice to
the defaulting Party; provided however that in the case of a material breach
capable of being cured, if the said defaulting Party shall cure the said
material breach within one hundred twenty (120)  calendar
days after the said notice shall have been given, then the said notice shall
not be effective.


 


33.3         Cross
Termination of Trademark License Agreement. In the event that the Trademark License Agreement
is terminated by either Party thereto on the terms and conditions thereof for
whatever reason, each of the Parties hereof shall likewise have the
right to terminate this Agreement forthwith by written notice.


 


33.4         Cross
Breach under Parent Guarantee Agreement. In the event that a material breach by Cephalon
occurs under the Parent Guarantee Agreement and that such breach by Cephalon is
not cured within the curing period set forth in that agreement or if such
breach is not curable by the nature of such breach or if Cephalon becomes
insolvent or is declared bankrupt, as defined in Clause 33.6 hereinafter, of
Cephalon, Immupharma shall have the right to terminate this Agreement
forthwith by written notice.


 


33.5         Non-Commercialization
or Development by Anesta


 


(A)          [**]


 


(B)           [**]


 


33.6         Insolvency
or Bankruptcy. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement
effective on written notice to the other Party in the event the other Party
shall have become insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or there shall have been appointed a trustee or
receiver of the other Party or for all or a substantial part of its property,
or any case or proceeding shall have been commenced or other action taken by or
against the other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any jurisdiction now or hereafter in effect, or there
shall have been issued a warrant of attachment, execution, distraint or similar
process against any substantial part of the property of the other Party, and
any such event shall have continued for ninety (90) calendar days undismissed,
unbonded and undischarged. Furthermore, all rights and licenses granted under
this Agreement are, and shall be deemed to be, for purposes of Section 365(n) of
the Bankruptcy Code, licenses of rights to “intellectual property” as defined
under Section 101(56) of the United States Bankruptcy Code. The Parties
agree that in the event of the commencement of a bankruptcy proceeding by or
against one Party hereunder 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


37

















 


under the United
States Bankruptcy Code, the other Party shall be entitled to complete access to
any such intellectual property, and all embodiments of such intellectual
property, pertaining to the rights granted in the licenses hereunder of the
Party by or against whom a bankruptcy proceeding has been commenced; subject,
to payment of the Development and Commercial Milestone amounts and Running
Royalties set forth in this Agreement.


 


33.7         Change
of Control.


 


(A)          Anesta.  ImmuPharma may terminate this Agreement in
the event that there is a change of control (defined below) of Anesta, unless
prior to such change of control Anesta (i) transfers or assigns all of its
rights and obligations under this Agreement to Cephalon or any of its
Affiliates or (ii) obtains the consent of ImmuPharma (such consent shall
not be unreasonably withheld).  For the
purposes of Clauses 33.7(A) and (B) only, a “change of control” shall
be deemed to have occurred when (i) any Entity, which is not an Affiliate
of the respective Party as at the Effective Date (the “Acquiror”),
directly or indirectly acquires ownership or control of fifty percent (50%) or
more of the equity or of the voting rights and/or otherwise acquires the
ability to direct the business affairs or the management of such Party or (ii) the
party controlling such Party shall become insolvent or shall be declared
bankrupt, as defined in Clause 33.6
hereinbefore.


 


(B)           ImmuPharma.  Anesta may terminate this Agreement in the
event that there is a change of control (defined above) of ImmuPharma, unless
prior to such change of control, ImmuPharma obtains the consent of Anesta
(suich conset shall not be unreasonably withheld).


 


33.8         General
Extraordinary Termination Right of Anesta. Until the first
NDA Approval, Anesta may terminate this Agreement at any time by giving ninety
(90) calendar days’ written notice to ImmuPharma. After the first NDA Approval,
Anesta may terminate this Agreement at any time by giving one hundred eighty
(180) calendar days prior written notice to ImmuPharma.


 


33.9         Written
Termination Agreement. The Parties may terminate
this Agreement by written agreement, signed on behalf of each Party.


 


34.           Effect of Extraordinary Termination


 


34.1         Existing
Obligations. The early termination of this Agreement
shall:


 


(A)          be without prejudice to the
obligation of Anesta to pay to ImmuPharma all Commercial and Development
Milestones, Running Royalties and other sums accrued, due and payable prior to
the termination of this Agreement; and


 


(B)           be without prejudice to any
right of, or remedy available to, either Party against the other in respect of
any breach of this Agreement prior to the termination of this Agreement, but
otherwise neither Party shall be entitled to compensation as a result of such
termination except as expressly stated in this Agreement.


 


35.           Further Consequences of Extraordinary Termination.


 


35.1         Early
Termination by ImmuPharma.  If this Agreement is terminated, either in
full by ImmuPharma pursuant to Clauses 33.2, 33.3 (solely in the event
ImmuPharma has terminated the Trademark Agreement due to Anesta’s breach),
33.4, 33.6, 33.7 or by Anesta pursuant to 33.8 or, in the event 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


38

















 


of a termination
or Non-Exclusivity pursuant to Clause 33.5 as to one or more specific countries
in the Territory (as applicable):


 


(A)          Anesta shall be fully bound
to strictly comply with all terms and conditions of this Agreement until the
effective date of termination and Anesta shall pay to ImmuPharma and shall
remain liable to ImmuPharma to pay any and all amounts which shall have fallen
due for payment or shall have become payable on or before the effective date of
termination;


 


(B)           Anesta shall either in full
or, in the event of a termination or Non-Exclusivity pursuant to Clause 33.5 as
to one or more countries, for such specific countries in the Territory (as
applicable) promptly return or furnish to ImmuPharma all Licensed Technical
Information or other information, documents provided to Anesta by ImmuPharma or
its Affiliates, in Anesta’s or its Affiliates or Anesta Sub-Licensees,
co-promoters or sub-contractors possession or control;


 


(C)           subject to Clause 35.1(D),
Anesta, its Affiliates, Sub-Licensees, co-promoters and sub-contractors shall
either in full or, in the event of a termination or Non-Exclusivity pursuant to
Clause 33.5 as to one or more countries, for such specific countries in the
Territory (as applicable) immediately cease to use and thereafter refrain from
using the Licensed Patents, the Licensed Technical Information, the Licensed
Trademarks, Licensed Molecules and the Licensed Products;


 


(D)          save as expressly provided
herein, all rights of Anesta, its Affiliates, Sub-Licensees, co-promoters and
sub-contractors hereunder and all licenses granted to Anesta and its Affiliates
hereunder shall either in full or, in the event of a termination or
Non-Exclusivity pursuant to Clause 33.5 as to one or more countries, for such
specific countries in the Territory (as applicable) forthwith cease and
terminate and, where applicable, Anesta shall assist ImmuPharma in taking all
steps necessary for the removal of the name of Anesta, its Affiliates,
Sub-Licensees, co-promoters and sub-contractors from any patent register at any
patent office where a patent license has been recorded, if any;


 


(E)           ImmuPharma shall have a
perpetual, fully paid-up, royalty-free, non-exclusive, irrevocable right, with
the right to sub-license such right, to use, either in full within the
Territory or, in the event of a termination or Non-Exclusivity pursuant to
Clause 33.5 as to one or more countries, for such specific countries in the
Territory (as applicable), any new Technical Information under Clause 20.2 and
Inventions under Clause 20.4, to the extent such Technical Information and
Inventions could not without a license from ImmuPharma be practiced without
infringing on the rights of the Licensed Patents or the Licensed Technical
Information, as well as all results of and documentation associated with
Clinical Studies for the Licensed Products or Licensed Molecules, which
proprietary information is owned by Anesta pursuant to Clauses 20.2 and 20.4
hereof for all possible applications and ImmuPharma shall have the right to use
such New Technical Information and new Inventions in the manufacturing process
of the Licensed Products or Licensed Molecules, through a manufacturer of its
choice, exclusively and solely for the delivery of Licensed Products or
Licensed Molecules to such country outside the Territory in which the license
or sublicense granted in this Agreement has been terminated or becomes Non-Exclusive
pursuant to Cluase 33.5;


 


(F)           Anesta shall either in full
or, in the event of a termination or Non-Exclusivity pursuant to Clause 33.5 as
to one or more countries, for such specific countries in the Territory (as
applicable) provide to ImmuPharma or ImmuPharma’s nominee(s) a copy of,
and shall transfer, or cause to be transferred, to ImmuPharma or ImmuPharma’s
nominee(s) all right, 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


39

















 


title and interest to all INDs and NDAs for Licensed Product held by or
on behalf of Anesta, its Affiliates or Anesta Sub-Licensees, including any
valid sub-licenses or assignments granted to Anesta for any and all data
included therein and ImmuPharma shall have a perpetual, fully paid-up,
royalty-free, non-exclusive, irrevocable right, with the right to sub-license
such right including rights to use all data therein, any new Technical
Information under Clause 20.2 and Inventions under Clause 20.4 to the extent such
proprietary information of Anesta is included in any or all INDs and NDA
Filings and Approvals for Licensed Product hereunder.  Until such transfer of INDs and NDA s for
Licensed Product is effected or if such transfer is not possible for legal or
regulatory reasons, Anesta shall ensure that ImmuPharma has the benefit of such
INDs and NDAs. Anesta shall consent and, where necessary, cause its Affiliates
of Anesta Sub-Licensees or their contractors to consent, for any relevant
Regulatory Authority to cross-reference such data and information contained in
such INDs and NDAs as may be necessary for the granting of second INDs and NDAs
to ImmuPharma or its nominee(s); this shall include Anesta’s  assignment to ImmuPharma or its designated
nominee, at no charge, of all rights in any and all trade product registrations
and all applications therefor with a Regulatory Authorities and any and all
marketing authorizations and applications therefor in the Territory obtained
directly or indirectly by Anesta, its Affiliates or Anesta Sub-Licensees with
respect to Licensed Products, and ImmuPharma shall assume responsibility for
any such product registrations and marketing authorizations and/or applications
therefor and may deal with such registrations, authorizations and/or
applications as it thinks fit;


 


(G)           Anesta shall either in full
or, in the event of a Non-Exclusivity pursuant to Clause 33.5 as to one or more
countries, for such specific countries in the Territory (as applicable) grant
to ImmuPharma AG, a nonexclusive, fully paid-up, royalty-free irrevocable license
to all rights in any and all trade names and trademarks used by Anesta
exclusively with respect to Licensed Products and Licensed Molecules and not
used by Anesta with respect to any other product, and ImmuPharma AG shall
assume responsibility for any registrations therefor and may deal with such
registrations as it thinks fit; and


 


(H)          at ImmuPharma’s request,
Anesta shall use all Commercially Reasonable Efforts to transfer
responsibilities for, and therefore enable ImmuPharma to continue, all further
clinical development and manufacturing activities being performed by or on
behalf of Anesta at the time of such termination either in full or, in the
event of a termination or Non-Exclusivity pursuant to Clause 33.5 as to one or
more countries, for such specific countries in the Territory (as applicable);
otherwise, however, Anesta shall cease such activities.


 


35.2         Early
Termination by Anesta.  If this Agreement is terminated by Anesta
pursuant to Clauses 33.2, 33.3 (solely in the event Anesta has terminated the
Trademark Agreement due to ImmuPharma’s breach), 33.6 or 33.7:


 


(A)          Anesta and its Affiliates
shall have an irrevocable right to use in each country of the Territory the
Licensed Technical Information, the Licensed Patents and any Inventions
comprised therein for the development, commercialization and exploitation of
Licensed Products or Licensed Molecules, [**] until the event or events of an
Ordinary Termination have occurred pursuant to Clause 32.1.


 


35.3         Survival.
Upon extraordinary termination of this Agreement under Clause 33 by either
Party hereto or the termination of this Agreement in respect of any specific
country under Clause 33.5 on the terms and conditions hereof, the following
Clauses and Sections hereof shall survive termination and the Parties shall
continue to be bound by them: Clauses 1, 8.1, 8.3, 8.4 (to the
extent applicable for Accounting Periods elapsed in full or in part during the
term hereof), 9 and 10 (both of 9 and 10


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


40
















 


to the extent
applicable for Accounting Periods elapsed in full or in part in such country
during the term hereof), 11.6, 20.1 to 20.6, 22.2, 22.3, 25, 29 to 31, 34, 37,
and 39 to 50 of this Agreement. 


 


(A)                              Marketing. To
the extent that Anesta, its Affiliates, Sub-Licensees, co-promoters and
sub-contractors are marketing Finished Goods in the Territory on termination of
this Agreement, other than pursuant to Clause 35.2 at ImmuPharma’s request, the
Parties will make reasonable arrangements to ensure a transition of
responsibility for marketing such Finished Goods to ImmuPharma or its nominee
whilst maintaining supply of Finished Goods to the market. The sale of such Finished Goods by Anesta or its Affiliates,
Sub-Licensees, co-promoters and sub-contractors in the interim period shall
continue to be subject to the payment of Running Royalties to ImmuPharma
hereunder. [**].


 


(B)                                Continuing
License. If this Agreement is extraordinarily terminated by
ImmuPharma pursuant to Clauses 33.3, 33.6. 33.7 or by Anesta pursuant to Clause
33.8 or, in the event of a termination or Non-Exclusivity pursuant to Clause
33.5 for any specific country in the Territory (as applicable) and ImmuPharma
wishes to sell Licensed Products or Licensed Molecules in the Territory or
appoint a replacement licensee to sell Licensed Products in the Territory, then
ImmuPharma shall pay, for a reasonable time, fair and reasonable Running
Royalties to Anesta for its rights to use any new Technical Information under
Clause 20.2 and new Inventions under Clause 20.4. In the event that this
Clause 35.3 applies, the Parties shall meet to discuss the level of such fair
and reasonable Running Royalties.  Such
fair and reasonable Running Royalties shall be intended to provide recompense
to Anesta in respect of a proportion of its direct costs (excluding any
payments made to ImmuPharma) for its development and registration activities
prior to termination in respect of the Licensed Products, to the extent that
such costs have not been recouped through any sales of Licensed Products.  Such Running Royalties shall only be payable
on net sales of Licensed Products or Licensed Molecules in the Territory by
ImmuPharma, its nominee or any replacement licensee(s).  ImmuPharma’s obligation to pay such Running
Royalties shall cease once cumulative Running Royalties paid to Anesta equal
such proportion of direct costs.  If
ImmuPharma and Cephalon cannot agree on such fair and reasonable Running
Royalties and/or the amount or proportion of such direct costs within one (1) calendar
month of the date of termination, then either Party may proceed in accordance
with Clause 39 of this Agreement.


 


36.                                 Assignments


 


36.1                          Non-Assignability.
Subject to Clause 36.2, neither this Agreement nor any of the rights and
obligations created herein is assignable by either Party without the prior
written consent of the other Party such consent not to be unreasonably withheld
or delayed, except that ImmuPharma may assign, pledge or encumber any claims or
other entitlements for payments of money under this Agreement for financing
purposes without the consent by Anesta.


 


36.2                          Exception.
Either Party shall have the right to assign the entire benefit of this
Agreement (subject to its entire burden) without the consent of the other Party
to any Entity which acquires or is a successor to its business relating to
Licensed Molecules or Licensed Product in full or in part. In addition, Anesta
shall have the right to assign all or any portion of this Agreement to Cephalon
or any Affiliate of Cephalon.


 


37.                                 Affiliates,
Sub-Licensees and Sub-contracting


 


37.1                          Affiliates,
Sub-Licensees and Third Parties. Each Party shall use
Commercially Reasonable Efforts to ensure that its Affiliates,  Sub-Licensees, co-promoters, permitted
sub-contractors or other Third 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


41

















 


Parties acting on its behalf hereunder comply with
such Party’s obligations on the terms and conditions of this Agreement.


 


37.2                          Liability.
Each Party reserves the right to fulfill its obligations under this Agreement
subject to the terms and conditions hereof through its Affiliates,
Sub-Licensees, co-promoters  and
sub-contractors permitted hereunder, and to exercise its rights under this
Agreement through its Affiliates, Sub-Licensees and permitted sub-contractors
provided however that such Party shall remain responsible to the other Party
for any and all of their actions in their fulfillment of such obligations and
exercise of such rights to the respective other Party hereunder.


 


37.3                          Anesta
Sub-Contracting. Anesta reserves the right
to conduct Clinical Studies through suitably qualified clinical research
investigators and clinical trial sites, but otherwise Anesta may not fulfill
its obligations under this Agreement through sub-contractors who are not Anesta
Affiliates, Anesta Sub-Licensees or co-promoters under Clause 3.4 or exercise its
rights under this Agreement through sub- contractors who are not Anesta
Affiliates or Anesta Sub-Licensees without obtaining prior written consent from
CNRS and ImmuPharma (whereby such consent of ImmuPharma shall not be
unreasonably withheld, but may be given subject to conditions to protect CNRS,
ImmuPharma’s interests under this Agreement and give them rights to use any
Technical Information and Inventions generated by any such Anesta
sub-contractors).


 


(A)                   [**]


 


(B)                     [**];


 


(C)                     [**];


 


(D)                    [**].


 


38.                                 Oversight
Committee


 


38.1                          Composition.
The Oversight Committee shall consist of one representative of each Party which
representative shall be a member of each Party’s executive management or board
of directors; such representatives shall use their good faith efforts to
mutually agree upon the proper course of action to resolve any Dispute referred
to the Oversight Committee.


 


38.2                          Meetings.
The Oversight Committee shall meet as necessary at mutually agreed locations
and may hold at least one physical meeting and if necessary further meetings
where appropriate by teleconference or videoconference. In the absence of any
agreement within the Oversight Committee, such meetings shall take place in
person in Switzerland or the United Kingdom or any other place, as agreed each
time between the Parties.


 


38.3                          Guests.
Either Party may invite other personnel to attend meetings of the Oversight
Committee.


 


38.4                          Other
Obligations. Where any Dispute is referred to the
Oversight Committee, the Parties shall continue to abide by their obligations
under this Agreement (including without limitation any and all of their
obligations to develop, supply, register or commercialise Licensed Products or
Licensed Molecules) to the extent that this Agreement has not been terminated
and such obligations are not part of or directly connected to part of the
subject matter of the Dispute.


 


38.5                          Costs
and Expenses. Each Party shall bear the costs and expenses
of its own representative on the Oversight Committee in connection with
Oversight Committee meetings and activities and, subject 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


42

















 


to any agreement
to the contrary between the Parties, the costs of any other personnel whom such
Party wishes to attend Oversight Committee meetings shall be borne by such
Party.


 


38.6                          English.
The Oversight Committee shall operate in the English language.


 


39.                                 General
Dispute Resolution and Arbitration


 


39.1                          Applicability.
The provisions of this Clause 39 shall apply in relation to any Dispute.


 


39.2                          Amicable
Settlement. Any Dispute arising pursuant to or in connection with the present Agreement or the validity,
interpretation, breach or enforcement hereof shall first be referred to
the Oversight Committee, to the extent that it has not already been so
referred, and the Parties shall use all Commercially Reasonable Efforts to amicably settle such disputes within 90 (ninety)
calendar days upon written notification of such dispute by either Party to the respective other Party with copy to the Oversight
Committee.


 


39.3                          Mediation. If
any Dispute is not resolved by the Oversight Committee within ninety (90)
Business Days after such dispute is referred to it, or such longer period as
the Oversight Committee may collectively and unanimously agree in writing, the
Parties agree first to attempt to settle it by mediation in accordance with the
United Centre for Effective Dispute Resolution Model Mediation Procedure
(www.cedr.co.uk). The place of mediation shall be London, England and the
language to be used in the mediation proceedings shall be English. The Parties covenant that they will
participate in the mediation in good faith, and that they will share equally in
its costs. All offers, promises, conduct and statements, whether oral or
written, made in the course of the mediation by any of the Parties, their agents, employees,
experts and attorneys, and by the mediator or any of its employees, are
confidential, privileged and inadmissible for any purpose, including
impeachment, in any arbitration or other proceeding involving the Parties, provided that evidence that
is otherwise admissible or discoverable shall not be rendered inadmissible or
non-discoverable as a result of its use in the mediation.


 


39.4                          Mediation
Notice. To initiate a mediation, a Party must give notice
in writing (such notice to be hereinafter referred to as a “Mediation Notice”)
to the other Party requesting a mediation. 
A copy of the request should be sent to the Centre for Effective Dispute
Resolution. If one of the Parties refuses
to participate in mediation then either Party may initiate arbitration in
accordance with Clause 39.5 hereof.


 


39.5                          Arbitration. If and to the extent that, any such dispute, claim or controversy has not
been settled through mediation pursuant to Clauses 39.3 and 39.4, within (i) thirty
(30) calendar days after the date the Mediation Notice is received or (ii) ten
(10) days after one of the Parties refuses to participate in mediation,
such dispute, claim or controversy shall, upon the filing of a Request for
Arbitration by either Party, be
referred to and finally resolved by arbitration
under the international commercial arbitration rules of the International
Chamber of Commerce; such rules are deemed to be incorporated by reference
into this section.  The place of
arbitration shall be London, England. The arbitration proceedings shall be
conducted in the English language and the arbitration award shall be in
English.  Notwithstanding anything else
in the rules of the International Chamber of Commerce, the arbitrator or
arbitrators for such arbitration shall have no relation to either Party, CNRS,
or any affiliate thereof, and the decision in the arbitration proceeding shall
be determined by the vote of a majority of the arbitrators.


 


39.6                          Injunctive
Relief. 
Notwithstanding anything in this Agreement, the Option Agreement or the
Trademark License Agreement, the Parties may seek injunctive relief and
specific performance in 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


43

















 


any court without
first adhering to the dispute resolution and arbitration procedures in this
Agreement.


 


40.                                 Waiver


 


40.1                          No Limitations. No relaxation, forbearance, delay or indulgence by either Party in enforcing
any of the terms and conditions of this Agreement or the granting of time by
either Party to the other shall prejudice, affect or restrict the rights and
powers of that said Party hereunder  nor shall any waiver by either
Party of any breach hereof operate as a waiver of or in relation to any
subsequent or any continuing breach hereof.


 


40.2                          Enforcement. A
waiver by one Party of a breach by the other of any term of this Agreement
shall not prevent the subsequent enforcement of that term and shall not be
deemed a waiver of any subsequent breach.


 


41.                                 General
Assurances


 


Either Party shall at any time upon the request of the other do and
execute all such acts, deeds, documents and things as may reasonably be
required by the other to perfect and complete the grant of any rights and
licenses conferred upon the other, including in particular (without prejudice
to the generality of the foregoing) entry into forms of license or other
instruments confirming such rights for registration with appropriate authorities.


 


42.                                 Severability


 


In the event that any Clause or any part of any
Clause contained in this Agreement is declared invalid or unenforceable by the
judgment or decree by consent or otherwise of a Court of competent jurisdiction
not subject to appeal, all other Clauses or parts of Clauses contained in this
Agreement shall remain (in so far as they have become effective in accordance
with this Agreement) in full force and effect and shall not be affected thereby
for the term of this Agreement.


 


43.                                 Entire Agreement


 


This Agreement and any
documents referred to herein set forth the entire agreement and understanding
of the Parties relating to the subject matter hereof, and merge all prior
discussions between them and all prior memoranda of intent or understanding.
Neither Party shall be bound by any definition, condition or representation
other than as expressly stated in this Agreement or as subsequently set forth
in writing and signed by the Party to be bound.


 


44.                                 Titles
and Headings


 


The titles of this Agreement
or any part within it and the headings to sections, Clauses and schedules in
this Agreement are included for the purpose of ease of reference only and shall
not have any effect on the construction and interpretation of the terms hereof.


 


45.                                 Costs of
Preparation


 


The Parties hereto shall pay
their own respective legal costs incurred in the preparation of this Agreement.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


44

















 


46.                                 Notices


 


Any notice or other document
to be given under this Agreement shall be given by sending the same in a
registered, prepaid airmail letter or by facsimile transmission to the address
of the relevant Party set out below or to such other address as such Party may
have notified to the other for the purposes hereof.  Any notice sent by post shall be deemed (in
the absence of evidence of earlier receipt) to have been delivered seven (7) Business
Days after despatch and in proving the fact of despatch it shall be sufficient
to show that the envelope containing such notice was properly addressed,
stamped and posted.  Any notice sent by
facsimile transmission shall be deemed to have been delivered on the next
Business Day following its despatch.


 


ImmuPharma’s Address:


 


ImmuPharma (France) S.A.


c/o
ImmuPharma plc


50 Broadway


Westminster


London SW1H 0BL


United Kingdom


Fax no: +44 20 7152 4001


For the attention of the
Chief Executive Officer


 


With copy to:


 


ImmuPharma France SA


Technopôle


40 rue Marc Seguin


 


F-68200 Mulhouse


France


For the attention of the Chairman


 


And with further copy to


 


Dr. Thomas M. Rinderknecht


Rinderknecht & Burger


Grafenauweg 6


CH-6300 Zug


Switzerland


Fax: + 41 41 726 60 66


 


Anesta’s Address:


 


Anesta AG


Barrenstrase 23


6300 Zug


Switzerland


 


With copy to:


 


Cephalon, Inc.


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


45

















 


41 Moores Road


Frazer,
PA 19355


USA


Fax
no:  +1 610 727-7652


For the attention of the
Vice President and Deputy General Counsel


 


And with further copy to


 


Ballard Spahr Andrews & Ingersoll, LLP


1735 Market Street


51st Floor


Philadelphia, Pennsylvania


U.S.A.


Fax:  +1 215 864 9043


For the attention of:  Brian D. Doerner


 


Any notice or other document
served by one Party on the other in accordance with the terms of this Agreement
shall be in the English language and shall not be validly served unless this
condition is complied with.


 


47.                                 Force
Majeure


 


47.1                          Neither
ImmuPharma nor Anesta (as the case may be) shall be held in breach of its
obligations hereunder to the extent only that due performance or observance of
such obligation is prevented or delayed by reason of act of God, war or other
hostilities, civil commotion, strikes, trade disputes, acts or restraints of
government, imposition or restrictions of imports or exports or any other
circumstances of a similar type, in each case beyond the reasonable control of
the respective Parties.


 


47.2                          The
Party affected by an event referred to in this Clause 47.2 shall forthwith
notify the other Party of the nature and effect of such event and both Parties
shall where the same is practicable use every reasonable endeavour to minimise
such effect and to comply with the respective obligations herein contained as
nearly as may be in their original form.


 


48.                                 No
Agency, Partnership or Joint Venture


 


Nothing in this Agreement
shall be construed as giving rise to the relationship of principal and agent,
partnership or joint venture or entitle either Party to make any representation
enter into any contract give a warranty or incur any liability on behalf of or
pledge the credit of the other Party and neither Party shall have authority or
power to bind the other Party or to contract in the name of and create a
liability against the other Party in anyway or for any purpose.


 


49.                                 Benefit
to Third Parties


 


No Party who is not a Party to this Agreement shall have any rights to
enforce any term of this Agreement, except where any rights or claims have been
validly assigned to any Third Party pursuant to Clause 36.


 


50.                                 Governing
Law


 


This
Agreement shall be governed by and construed and interpreted in accordance with
the laws of Switzerland with the exclusion of the Vienna Convention on the
International Sale of Goods and without reference to the principles of
conflicts of laws thereof. To the extent that any relationship 


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


46

















 


between
the Parties hereto or thereto by applicable mandatory law is subject to any
other law, such other law shall govern such relationship only, and all other
relationships shall remain governed by the laws of Switzerland.


 


[Signature
Page Follows]


 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.


 


47

















 


IN WITNESS
WHEREOF, THE PARTIES HAVE EXECUTED THIS AGREEMENT TO BE EFFECTIVE AS OF THE
EFFECTIVE DATE:


 


IMMUPHARMA
(FRANCE) S.A.


 


	
  By:

  	
   /s/ Robert Zimmer

  	
   

  
	
  Name:  Robert Zimmer

  	
   

  
	
  Title:   
  Chairman of the Board

  	
   

  
	
   

  	
   

  
	
  In the presence of:

  	
   

  	
   

  
	
  Name:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  ANESTA AG

  	
   

  
	
   

  	
   

  
	
  By:

  	
   /s/ J. Kevin Buchi

  	
   

  
	
  Name:  J. Kevin
  Buchi

  	
   

  
	
  Title:  
  Chairman

  	
   

  
	
   

  	
   

  
	
  In the presence of:

  	
   

  	
   

  
	
  Name:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  With respect to Clause 2.1:

  	
   

  
	
   

  	
   

  
	
  ESCROW AGENT

  	
   

  
					



 


**   Portions of
the Exhibit have been omitted and have been filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.