Exhibit 10.14


 


CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN
OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT.  THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.


 


Execution
Copy


 


 


LICENSING
and DISTRIBUTION AGREEMENT


 


by and between


 


ZOGENIX, Inc.


 


and


 


DESITIN ARZNEIMITTEL GmbH


 













 


	
  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 2

  



 


TABLE  OF  CONTENTS


 


 


 


	
  1.

  	
   

  	
  DEFINITIONS . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  GRANT OF LICENSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . 

  	
   

  	
  8

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
   

  	
  TRADEMARK . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  9

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
   

  	
  PRODUCT STEERING COMMITTEE (“SC”) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . 

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
   

  	
  DEVELOPMENT AND COMMERCIALISATION OF THE
  PRODUCT . . . . . . . . . . . . . . . .
  . . . . . . . 

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
   

  	
  MANUFACTURE AND SUPPLY OF THE PRODUCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . 

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
   

  	
  MARKETING . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
   

  	
  PRICING . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
   

  	
  ROYALTIES . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  15

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
   

  	
  PAYMENT TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  16

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
   

  	
  RECORDS AND REPORTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  12.

  	
   

  	
  INFRINGEMENT OF RIGHTS BY THIRD PARTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . 

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.

  	
   

  	
  INFRINGEMENT OF THIRD PARTY RIGHTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . 

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14.

  	
   

  	
  INDEMNIFICATION AND INSURANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . 

  	
   

  	
  19

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15.

  	
   

  	
  IMPROVEMENTS AND PATENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16.

  	
   

  	
  RIGHT OF FIRST REFUSAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . .  . . . 

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17.

  	
   

  	
  REGULATORY . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  18.

  	
   

  	
  PHARMACOVIGILANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  19.

  	
   

  	
  EXCHANGE OF INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . .  . .
  . . 

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  21.

  	
   

  	
  TERM AND TERMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . 
  . . . 

  	
   

  	
  24

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  22.

  	
   

  	
  CONSEQUENCES OF TERMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . .  . . . 

  	
   

  	
  26

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  23.

  	
   

  	
  CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . 

  	
   

  	
  26

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  24.

  	
   

  	
  REPRESENTATIONS AND WARRANTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . . . . . . . . 

  	
   

  	
  28

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  25.

  	
   

  	
  FORCE MAJEURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  29

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  26.

  	
   

  	
  NOTICES . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . . . . 

  	
   

  	
  29

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  27.

  	
   

  	
  ASSIGNMENT . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  28.

  	
   

  	
  GENERAL PROVISIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  



 


LIST OF APPENDICES


 


	
  Appendix 1

  	
   

  	
  Product Specification

  
	
  Appendix 2

  	
   

  	
  Licensed Patents

  
	
  Appendix 3

  	
   

  	
  Clinical Supply Terms

  



 













 


	
  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 3

  



 


LICENSING & DISTRIBUTION AGREEMENT


 


THIS LICENSING &
DISTRIBUTION AGREEMENT is entered into on this  14 day of March, 2008,

by and between


 


	
  1.

  	
   

  	
  ZOGENIX, Inc. a company incorporated and
  existing under the laws of Delaware whose registered office is at 11682 El
  Camino Real, Suite 320, San Diego, CA 92130, U.S.A. (“ZOGENIX”);

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  and

  
	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  DESITIN Arzneimittel GmbH, a company incorporated and
  existing under the laws of Germany whose registered office is at Weg
  beim Jaeger 214, 22335 Hamburg, Germany (“DESITIN”);

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Each also referred to as “Party”
  or together as “Parties”.

  
	
   

  	
   

  	
   

  
	
  RECITALS

  
	
   

  	
   

  	
   

  
	
  A.

  	
   

  	
  ZOGENIX is, amongst others, active in the research
  and development of pharmaceuticals and medical devices and has developed
  Sumatriptan DoseProTM for migraine patients for which ZOGENIX
  intends to register the product in the U.S.A.

  
	
   

  	
   

  	
   

  
	
  B.

  	
   

  	
  DESITIN specialises in the manufacture, marketing
  and sale of branded pharmaceuticals, in particular CNS related products, in
  the Territory and desires to enter into a contractual relationship with
  ZOGENIX to develop, obtain regulatory approval and commercialise the Product
  in the Territory.

  
	
   

  	
   

  	
   

  
	
  C.

  	
   

  	
  The Parties hereby enter into the Agreement on the
  terms and conditions as stipulated herein below.

  
	
   

  	
   

  	
   

  
	
  NOW THEREFORE, the Parties hereby agree as follows:

  



 













 


1.                         DEFINITIONS


 


As used in this Agreement,
unless expressly otherwise stated or evident in the context, the following
terms shall have the meanings defined below. The singular (where appropriate)
shall include the plural and vice versa and references to Appendices and
Clauses shall mean appendices and clauses of this Agreement.


 


	
  1.1

  	
   

  	
  Affiliate

  	
   

  	
  shall mean any
  firm, person or company which controls, is controlled by or is under common
  control with a Party to this Agreement and, for the purpose of this
  definition, the term “control” means the possession, directly or indirectly,
  of the power to direct or cause the direction of the management and policies
  of such firm, person or company, whether through the ownership of voting
  securities, by contract or otherwise, or the ownership either directly or
  indirectly of 50% or more of the voting securities of such firm, person or
  company;

  
	
  1.2

  	
   

  	
  Agreement

  	
   

  	
  shall mean this licensing and distribution agreement
  and the appendices hereto;

  
	
  1.3

  	
   

  	
  BfArM

  	
   

  	
  shall mean Bundesinstitut für Arzneimittel und
  Medizinprodukte (Federal Institute for Drugs and Medical Devices) in Germany,
  and any successor agency thereto;

  
	
  1.4

  	
   

  	
  Business Day

  	
   

  	
  shall mean any day other than Saturday or Sunday on
  which the banks in London are open for business;

  
	
  1.5

  	
   

  	
  Clinical Trial Materials

  	
   

  	
  shall mean the Product to be used by DESITIN in
  connection with the development and registration process in the Territory;
  for the avoidance of doubt Clinical Trial Materials shall exclude all
  packaging and blinding thereof;

  
	
  1.6

  	
   

  	
  Confidential Information

  	
   

  	
  shall mean any scientific, technical, formulation,
  process, manufacturing, clinical, non-clinical, regulatory, marketing,
  financial or commercial information or data relating to the business,
  projects or products of either Party and provided by one Party to the other
  by written, oral, electronic or other means in connection with this
  Agreement;

  
	
  1.7

  	
   

  	
  cGMP

  	
   

  	
  shall mean current good manufacturing practices as
  set out under the European Directive 2003/94/EC and promulgated by the
  International Conference on Harmonisation, as the same may be modified or
  amended from time to time;

  
	
  1.8

  	
   

  	
  “Cost of Goods
  Manufactured”

  	
   

  	
  shall mean costs to produce Clinical Trial Materials
  and/or commercial supplies of Product to the extent that such costs would
  ordinarily be included as a Cost of Goods sold in accordance with U.S.
  generally accepted accounting principles, including: (a) the amounts paid by
  ZOGENIX or its Affiliates for (i) 
  manufacturing, filling and/or finishing Product, but excluding costs,
  charges and allocations related to or occasioned by unused manufacturing
  capacity, (ii) transporting, storing and insuring Product, and (iii) testing
  Product, including with respect to the foregoing subsections (i) - (iii), all
  taxes (other than income taxes) and customs duty charges imposed by
  governmental authorities with respect thereto; (b)  to the extent not included in subsection
  (a), the direct costs and charges incurred by ZOGENIX or its Affiliates in
  connection with the manufacture, filling, finishing, testing, storing,
  insuring and transportation of the Product, including direct internal costs
  with respect thereto; (c) to the extent not included in subsection (a),
  ZOGENIX’s or its Affiliate’s intellectual property acquisition and licensing
  costs (including royalties) paid to Third Parties (i) directly allocable to
  the applicable Product to the extent that such intellectual property is
  required for the manufacture of such Product in the country of manufacture
  and (ii) actually incurred by ZOGENIX or its Affiliates and not otherwise
  reimbursed by or paid for by any Third Parties; and (d) to the extent not
  included in subsection (a), allocable depreciation, amortization and
  facilities costs (e.g., sewer, water, property taxes), with any such
  allocations made on the basis of theoretical full capacity operation of the
  relevant facility, adjusted for changeovers in production runs, and excluding
  costs and charges related to or occasioned by (i) unused manufacturing
  capacity not reserved for the production of Product; (ii) the manufacture of
  other products at the manufacturing party’s facilities, and (iii) allocation
  of general corporate overhead;

  
	
  1.9

  	
   

  	
  Change of Control

  	
   

  	
  shall have the meaning as given to it in Clause 2.3;

  
	
  1.10

  	
   

  	
  Committee Members

  	
   

  	
  shall have the meaning as given to it in Clause 4.1;

  
	
  1.11

  	
   

  	
  Data

  	
   

  	
  shall mean (a) written materials and information concerning the
  Product, including copies, or summaries, of materials prepared for submission
  to the Regulatory Authorities concerning the Product or its labeling;
  (b) such clinical data and documentation in respect of the Product
  generated by 

  



 













 


	
  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 5

  



 


	
   

  	
   

  	
   

  	
   

  	
  research and trials funded by a Party or to which a Pary may have
  access with the right to disclose; and (c) safety information in respect
  of the Product generated by a Party.

  
	
  1.12

  	
   

  	
  DESITIN

  	
   

  	
  shall have the meaning as given to it in Clause 2 of the recitals of
  this Agreement;

  
	
  1.13

  	
   

  	
  DESITIN`s Net Sales

  	
   

  	
  shall mean the gross price billed by DESITIN or its
  Affiliates to independent parties for sales of the Product less (i) customary
  cash and credit discounts (other than mandatory rebates) provided that such
  deductions under this subsection (i) shall not exceed in average during a
  calendar year [***]% of the gross amount invoice of the Product
  in the Territory; (ii) allowances given the customers for normal returns and
  recalls; (iii) sales and similar taxes, and (iv) mandatory rebates or any
  other measures with like effect imposed by operation of law, by any
  Regulatory Authority; (v) rebates granted to managed healthcare organisations
  or to federal, state or local governments, their agencies, purchasers and
  reimbursers or to trade customer; (vi) tax, tariff or custom duties or other
  duties or governmental charges (except for income tax) levied on the sale,
  transportation, import or delivery of the Product; (vii) freight, shipping
  and insurance costs relating to the Product or retroactive price reductions,
  provided that such deductions under this subsection (vii) shall not exceed [***]% of
  gross amount invoice of the Product in the Territory during any calendar year, but in each case only if paid by DESITIN or actually
  charged against DESITIN and evidenced in DESITIN’s books and records of
  account and the reports provided to ZOGENIX pursuant to Clause 10.3 hereof;

  
	
  1.14

  	
   

  	
  DESITIN Parties

  	
   

  	
  shall have the meaning as given to it in Clause
  14.1;

  
	
  1.15

  	
   

  	
  Dossier

  	
   

  	
  shall mean the dossier of information and data
  filed, or to be filed with BfArM in relation with the application for
  Marketing Authorisation in Germany and other countries in the European Union
  or with a comparable Regulatory Authority, including any amendments thereto;

  
	
  1.16

  	
   

  	
  Effective Date

  	
   

  	
  shall mean the date of this Agreement;

  
	
  1.17

  	
   

  	
  Field

  	
   

  	
  shall mean all therapeutic uses of the Product in
  humans;

  
	
  1.18

  	
   

  	
  First Commercial Sale

  	
   

  	
  shall mean the date of first invoice of Desitin for
  deliveries to wholesalers, hospital pharmacies, pharmacies or other
  independent parties;

  
	
  1.19

  	
   

  	
  Force Majeure

  	
   

  	
  shall mean in relation to either Party any
  circumstances beyond the reasonable control of that Party;

  
	
  1.20

  	
   

  	
  Improvement

  	
   

  	
  shall mean any discovery, development, invention,
  enhancement or modification, patentable or otherwise, relating to the Product
  in the Territory owned or controlled by ZOGENIX or its Affiliates during the
  Term, including any modification or enhancement in the method of formulation,
  dosage strains, analytical methodology ingredients, preparation,
  presentation, means of delivery or administration, indication, use or
  packaging of the Product. For the avoidance of doubt, “Improvement” shall not
  include Intellectual Property Rights which relate to line extensions of the
  Product or indications which are in addition to those for which ZOGENIX has
  requested Marketing Authorisation in the United States on or before the
  Effective Date;

  
	
  1.21

  	
   

  	
  Initial Term

  	
   

  	
  shall have the meaning as given to it in Clause
  21.1;

  
	
  1.22

  	
   

  	
  Intellectual Property
  Rights

  	
   

  	
  shall mean patents, trademarks, service marks,
  logos, trade names, rights and designs, copyright, utility models, rights and
  know how and other intellectual property rights, in each case whether registered
  or unregistered and including applications for registration and all rights or
  forms of protection having equivalent or similar effect anywhere in the
  world;

  
	
  1.23

  	
   

  	
  Key Facts

  	
   

  	
  shall mean basic information used by DESITIN and its
  Affiliates in marketing or promoting the Product including but not limited to
  information on indications, dosage, side effects and selling points used for
  the positioning within current and future market environment;

  
	
  1.24

  	
   

  	
  Launch

  	
   

  	
  means the commencement of
  commercial sale of the Product in the respective country of the Territory
  after receipt of Marketing Authorisation in that country of the Territory;

  



 


*** Certain information on
this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.


 













 


	
  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 6

  



 


	
  1.25

  	
   

  	
  Licensed Know-how

  	
   

  	
  shall mean all information,
  procedures, instructions, techniques, data, technical information, knowledge
  and experience (including toxicological, pharmaceutical, clinical,
  non-clinical and medical data, health registration data and marketing data),
  designs, sales and marketing materials and technology, including without
  limitation Data, owned or controlled by Zogenix during the Term and necessary
  to use, distribute, sell, or offer for sale the Product in the Territory
  whether in written electronic or other form, including the Dossier.
  Notwithstanding the foregoing, Licensed Know-How shall exclude any and all
  Manufacturing Know-How;

  
	
  1.26

  	
   

  	
  Licensed Patents

  	
   

  	
  shall mean all Patent Rights owned or controlled by
  Zogenix during the Term and reasonably necessary to use, distribute, sell or
  offer for sale the Product in the Territory. As of the Effective Date, the
  Licensed Patents consist of those Patents set forth on Appendix 2 to this
  Agreement;

  
	
  1.27

  	
   

  	
  Licensed Technology

  	
   

  	
  shall mean the Licensed Know How and the Licensed
  Patents and any Improvements thereto;

  
	
  1.28

  	
   

  	
  Manufacturing Agreement

  	
   

  	
  Shall mean the agreement to be entered into by the
  Parties as set out in Clause 6.2 and pursuant to which ZOGENIX shall be the
  exclusive supplier of all of DESITIN’s, its Affiliates’ and its permitted
  sub-licensees’ requirements of Product for commercial use and/or sale in the
  Territory;

  
	
  1.29

  	
   

  	
  Manufacturing Know-How

  	
   

  	
  shall mean any and all of the following, to the
  extent both (a) owned or controlled by Zogenix or any respective
  Affiliate of Zogenix (other than an Acquiror of Zogenix), as the case may be,
  and (b) related to Products: methods of manufacturing, production and
  test methods, procedures and batch records, manufacturing and testing summary
  data, process and assay validation information, and any other information,
  procedures, instructions, techniques, data, technical information, knowledge
  and experience (including regulatory) related to manufacturing, manufacturing
  process development and scale-up, manufacturing capacity, manufacturing
  facilities, product testing, product release, quality assurance activities,
  or stability tests;

  
	
  1.30

  	
   

  	
  Marketing Authorisation

  	
   

  	
  shall mean the grant of all necessary permits,
  authorisations, licences and approvals (or waivers) from any Regulatory
  Authority required for the research, development, manufacture, promotion, storage,
  import, export, transport or use of the Product in the Territory;

  
	
  1.31

  	
   

  	
  MOH

  	
   

  	
  shall mean the Ministry of Health or equivalent
  governmental body responsible for granting Marketing Authorisation in each
  respective country within the Territory;

  
	
  1.32

  	
   

  	
  Other Territories

  	
   

  	
  shall mean
  the world except for the Territory;

  
	
  1.33

  	
   

  	
  Party

  	
   

  	
  shall have
  the meaning as given to it in the Preamble;

  
	
  1.34

  	
   

  	
  Patent Rights

  	
   

  	
  shall mean patents or patent applications; and any
  divisionals, continuations, substitutions, continuations-in-part, extensions,
  renewals, re-examinations or reissues of such patents or applications, as
  applicable, in each case in the Territory;

  
	
  1.35

  	
   

  	
  Pharmaco-vigilance
  Agreement

  	
   

  	
  shall mean the agreement to be entered into by the
  Parties as set out in Clause 18.1 and pursuant to which the Parties shall
  fulfil the applicable pharmaceutical rules and regulations in the
  Territory and the Other Territories;

  



 













 


	
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  1.36

  	
   

  	
  Product

  	
   

  	
  shall mean the medical device DosePro with
  Sumatriptan as the sole active ingredient as specified in the Product
  Specification;

  
	
  1.37

  	
   

  	
  Product Specification

  	
   

  	
  shall mean the specifications as defined for the
  Product in Appendix 1 to this Agreement;

  
	
  1.38

  	
   

  	
  Reasonable Commercial
  Efforts

  	
   

  	
  shall mean commercial efforts consistent with normal
  business practices and effort used by a Party in connection with other
  products of similar market size or importance which such Party intends to
  launch or has launched and sold in the relevant Territory, or in the absence
  of any such similar products then such efforts shall be assessed by reference
  to good business practice in the light of all the circumstances;

  
	
  1.39

  	
   

  	
  Regulatory Authority

  	
   

  	
  shall mean any and all governmental and regulatory
  bodies, agencies, departments or entities, whether or not located in the
  Territory, which regulate, direct or control commerce in or with the
  Territory, including any competent agency, body or entity from time to time
  responsible for granting Marketing Authorisations;

  
	
  1.40

  	
   

  	
  Remedies

  	
   

  	
  shall have the meaning as given to it in Clause
  12.1;

  
	
  1.41

  	
   

  	
  ROFR

  	
   

  	
  shall have the meaning given to it in Clause 16;

  
	
  1.42

  	
   

  	
  Royalty

  	
   

  	
  shall have the meaning as given to it in Clause 9.1;

  
	
  1.43

  	
   

  	
  Samples

  	
   

  	
  shall mean certain quantities of the Product to be
  used in the Territory for advertising and marketing purposes only, any sale
  being strictly prohibited;

  
	
  1.44

  	
   

  	
  Term

  	
   

  	
  shall mean the Initial Term as the
  same may be extended pursuant to Clause 21.2.

  
	
  1.45

  	
   

  	
  Territory

  	
   

  	
  shall mean the countries of the
  European Union (defined below and thereafter as constituted from time to
  time) plus Norway, Switzerland and Turkey, to the extent not otherwise
  included in the European Union:  The countries of
  the European Union as of the Effective Date are as follows:  Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
  Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
  Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia,
  Slovenia, Spain, Sweden, United Kingdom;

  
	
  1.46

  	
   

  	
  Third Party

  	
   

  	
  shall mean any person or entity
  who or which are neither a Party nor an Affiliate of a Party;

  
	
  1.47

  	
   

  	
  Trademark

  	
   

  	
  shall mean the trademark “DosePro” or any trademark
  containing “DosePro” or such other substitute trademark as Zogenix following
  consultation with DESITIN determines to use instead of “DosePro”. For the
  avoidance of doubt, “Trademark” does not include the trademark ZogenixTM and
  any other related trademark or service mark (whether registered or
  unregistered) containing the word “Zogenix”;

  
	
  1.48

  	
   

  	
  Transfer Price

  	
   

  	
  shall have the meaning as given to
  it in Clause 8.3;

  
	
  1.49

  	
   

  	
  ZOGENIX

  	
   

  	
  shall have the meaning as given to it in Clause 1 of
  the recitals to this Agreement;

  
	
  1.50

  	
   

  	
  ZOGENIX Parties

  	
   

  	
  shall have the meaning as given to it in Clause
  14.2.

  



 













 


	
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  2.

  	
   

  	
  GRANT OF LICENSE

  
	
   

  	
   

  	
   

  
	
  2.1

  	
   

  	
  Subject to the terms of this Agreement, ZOGENIX
  hereby grants to DESITIN an exclusive license under the Licensed Technology
  to develop, use, distribute, sell, offer for sale, and import the Product in
  the Field and in the Territory.

  
	
   

  	
   

  	
   

  
	
  2.2

  	
   

  	
  The term “exclusive” for the purposes of clause
  2.1 means to the exclusion of all others, including ZOGENIX and its
  Affiliates, except to the extent necessary to enable ZOGENIX to perform its
  obligations under this Agreement.

  
	
   

  	
   

  	
   

  
	
  2.3

  	
   

  	
  DESITIN shall have the right to sub-license all or
  any of the rights licensed under this Agreement to its Affiliates and any
  Third Party, provided that DESITIN shall:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  provide ZOGENIX
  with a copy of such sub-license agreement promptly after the execution of any
  sub-license covering the Territory, which sub-license agreement is consistent
  with the terms of this Agreement insofar as they are applicable, but
  excluding the right to grant a sublicense, and contains terms that are no
  less restrictive than those contained in this Agreement on audit, inspection,
  and confidentiality;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  if the
  sub-licensee is not an Affiliate of DESITIN seek ZOGENIX’s prior written
  consent, which consent shall not be unreasonably withheld; provided that
  ZOGENIX may request adequate background and other information on the proposed
  sub-licensee and if DESITIN is unable to reasonably satisfy ZOGENIX as to
  such background and other information or that ZOGENIX will continue to
  receive the economic benefit of its bargain as if DESITIN were continuing to
  market and promote the Product under this Agreement, ZOGENIX may withhold its
  consent;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  if the
  sub-licensee is an Affiliate of DESITIN at the time of the sub-license
  hereunder and thereafter the sub-licensee ceases to be an Affiliate of
  DESITIN (a “Change of Control”), unless
  ZOGENIX grants its prior written consent (pursuant to the procedure set forth
  in Clause 2.3(b)) it is agreed that the sub-license granted to former
  Affiliates of DESITIN shall automatically terminate when the Change of
  Control becomes effective; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  DESITIN shall be
  liable to ZOGENIX for acts or omissions of any Affiliate or permitted
  sub-licensee and shall solely be responsible for any claim made by any
  Affiliate or permitted sub-licensee against ZOGENIX; provided that in each
  case, such claims do not arise from any act or omission of the ZOGENIX
  Parties.

  
	
   

  	
   

  	
   

  
	
  2.4

  	
   

  	
  The license
  granted under Clause 2.1 includes sub-licenses under any Intellectual
  Property Rights included within the Licensed Technology which have, prior to
  the Effective Date, been licensed by ZOGENIX from any Third Party. Any
  royalties or other payments due to any Third Party pursuant to such a Third
  Party license shall be paid by ZOGENIX.

  
	
   

  	
   

  	
   

  
	
  2.5

  	
   

  	
  Each Party shall
  have access to the other Party’s Data and shall have a right to use such Data
  in their respective territories. For the avoidance of doubt, DESITIN’s right 

  



 













 


	
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  Page 9

  



 


	
   

  	
   

  	
  to use the Data
  shall be limited to its use in satisfying its obligations or pursuing its
  rights under this Agreement during the Term and ZOGENIX shall have a
  perpetual right to use the Data of DESITIN during the Term and following any
  expiration or termination of this Agreement.

  
	
   

  	
   

  	
   

  
	
  2.6

  	
   

  	
  Notwithstanding anything in this Agreement to the
  contrary, ZOGENIX shall, as between the Parties, retain: (a) the
  exclusive right to manufacture and supply Product for all fields of use; and
  (b) develop, register, import, export, use, and sell the Product outside
  the Territory.

  
	
   

  	
   

  	
   

  
	
  2.7

  	
   

  	
  ZOGENIX reserves the right to modify and/or to
  discontinue developing or producing the Product at its discretion at any time
  either (1) due to legal or regulatory requirements, administrative or
  court orders, or safety risks, or (2) so long as the Product in question
  is withdrawn from the market throughout the European Union for a justified
  and reasonable motive; provided, however, that ZOGENIX shall notify DESITIN
  as soon as practicable after any such modification or discontinuance and
  DESITIN shall be entitled to market any modified versions of Product pursuant
  to the terms of this Agreement. Nothing in this Agreement shall be deemed to
  restrict ZOGENIX from selling the Product or other products to Persons
  outside the Territory. ZOGENIX shall not authorize purchasers or distributors
  in Other Territories to sell the Product in the Territory. However, if by
  operation of law, the purchasers or distributors in Other Territories are
  permitted to sell the Product in the Territory, DESITIN shall receive no
  compensation.

  
	
   

  	
   

  	
   

  
	
  3.

  	
   

  	
  TRADEMARK

  
	
   

  	
   

  	
   

  
	
  3.1

  	
   

  	
  Subject to the
  terms of this Agreement, ZOGENIX hereby grants to DESITIN, its Affiliates and
  permitted sub-licensees a license to the Trademark for no additional
  consideration.

  
	
   

  	
   

  	
   

  
	
  3.2

  	
   

  	
  DESITIN will use
  the Trademark to identify the Product and in its development and
  commercialisation of the Product in the Territory. Therefore, DESITIN shall
  use the Trademark as part of the Product name along with such other words as
  ZOGENIX and DESITIN shall mutually agree are appropriate for the
  commercialisation of the Product in the Territory. The Trademark shall be
  owned and registered by ZOGENIX or its nominee and ZOGENIX or its nominee
  shall ensure that the registration of such Trademark is kept valid within the
  Territory, unless otherwise agreed upon between the Parties in writing.

  
	
   

  	
   

  	
   

  
	
  3.3

  	
   

  	
  The Trademark
  shall only be used in connection with sale and marketing of the Product
  within the Field and other activities pursuant to this Agreement in the
  Territory.

  
	
   

  	
   

  	
   

  
	
  3.4

  	
   

  	
  DESITIN shall
  ensure that each use by it, its Affiliates and permitted sub-licensees of the
  Trademark is accompanied by an acknowledgement that the Trademark is owned by
  ZOGENIX. DESITIN, its Affiliates and permitted sub-licensees shall not
  (A) use the Trademark in a way that might materially prejudice its
  distinctiveness or validity or 

  



 













 


	
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  Page 10

  



 


	
   

  	
   

  	
  the goodwill of
  ZOGENIX therein, or (B) use any trademarks or trade names so resembling
  the Trademark as to be likely to cause confusion or deception.

  
	
   

  	
   

  	
   

  
	
  3.5

  	
   

  	
  DESITIN shall not
  have, assert or acquire any right, title or interest in or to the Trademark
  or the goodwill pertaining thereto, except as explicitly provided in Clause
  3.1 of this Agreement.

  
	
   

  	
   

  	
   

  
	
  3.6

  	
   

  	
  DESITIN shall
  give ZOGENIX prompt notice of any infringement or threatened infringement of
  the Trademark. ZOGENIX shall determine in its sole discretion what action, if
  any, to take in response to the infringement or threatened infringement of
  the Trademark.

  
	
   

  	
   

  	
   

  
	
  4.

  	
   

  	
  PRODUCT STEERING COMMITTEE (“SC”)

  
	
   

  	
   

  	
   

  
	
  4.1

  	
   

  	
  The Parties shall establish a SC consisting of
  four (4) individuals (“Committee Members”);
  two of whom shall be nominated by ZOGENIX; and two of whom shall be nominated
  by DESITIN. The Committee Members may be replaced by written notice to the
  other Party and shall be appropriately qualified and experienced in order to
  make a meaningful contribution to SC meetings.

  
	
   

  	
   

  	
   

  
	
  4.2

  	
   

  	
  The purpose of the SC is to provide a forum for
  the Parties to share information on the ongoing research, development and
  commercialisation of the Product including monitoring progress of clinical
  studies, reviewing clinical trial programmes, considering proposed marketing
  and promotional plans, reviewing competitor activity and discussing any
  regulatory, technical, quality assurance or safety issues in relation to the
  Product.

  
	
   

  	
   

  	
   

  
	
  4.3

  	
   

  	
  The SC shall ensure the mutual exchange of Data,
  whether derived by Zogenix or DESITIN or their respective Affiliates or
  permitted sub-licensees. Each Party shall provide to the
  other Party such assistance as is reasonably necessary in respect of Regulatory
  Approvals in their respective territories, and in particular shall provide
  access to such Party’s Data, to the extent the Party providing such access is
  is legally and contractually permitted to do so, and, with respect to ZOGENIX
  providing DESITIN access, limited to DESITIN’s use in obtaining Regulatory
  Approvals in respect of the Product.

  
	
   

  	
   

  	
   

  
	
  4.4

  	
   

  	
  The SC shall meet as often as the Committee
  Members may determine, but in any event not less than twice per calendar year
  until approval of the first Marketing Authorisation and at least annually in
  the subsequent commercialisation period. Either Party may request additional
  SC meetings insofar it deems necessary for the development or
  commercialisation of the Product in the Territory. The Committee Members may
  invite individuals with special skills to attend meetings where it is
  considered to be relevant and appropriate. The quorum for SC meetings shall
  be two Committee Members, comprising one Committee Member from each Party.
  Each SC meeting shall be chaired by ZOGENIX. The Parties shall act in good
  faith and cooperate with one another in the development, marketing and
  commercialisation of the Product in the Territory.

  
	
   

  	
   

  	
   

  
	
  4.5

  	
   

  	
  The SC shall take its decisions unanimously. In
  the event the SC is unable to take a decision unanimously, ZOGENIX shall have
  the final say on development and 

  



 













 


	
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  Page 11

  



 


	
   

  	
   

  	
  manufacturing matters related to the Product in
  the Territory and DESITIN shall have final say on commercialisation matters
  related to the Product in the Territory (provided that DESITIN shall consult
  with ZOGENIX and consider any input received from ZOGENIX with respect to any
  pricing discussions with Regulatory Authorities related to the Product in the
  Territory).

  
	
   

  	
   

  	
   

  
	
  5.

  	
   

  	
  DEVELOPMENT AND COMMERCIALISATION OF THE PRODUCT

  
	
   

  	
   

  	
   

  
	
  5.1

  	
   

  	
  ZOGENIX shall, within [***] days from the
  Effective Date, deliver to DESITIN (to the extent available) the Licensed
  Know-How as of the Effective Date, to the extent that ZOGENIX is legally and
  contractually permitted to do so, and as required for the development,
  regulatory approval, commercialisation or use of the Product in the
  Territory.

  
	
   

  	
   

  	
   

  
	
  5.2

  	
   

  	
  DESITIN shall, at its sole cost, use Reasonable Commercial
  and scientific Efforts (without being required to use all available
  resources) to develop, obtain Marketing Authorisation(s) and
  commercialise the Product in the Territory, including obtaining all required
  approvals to market the Product in the Territory. DESTIN shall conduct its
  activities hereunder in a lawful manner and in accordance with the
  well-established pharmaceutical product development and commercialisation
  practices and the competition law applicable in each respective country in
  the Territory, and shall cause its employees, Affiliates and permitted
  sub-licensees to do the same. In particular DESITIN shall take all necessary
  steps to obtain Marketing Authorisation and prepare the Launch of the Product
  in Germany. In exploring in which other countries of the Territory the
  obtaining of Marketing Authorisation and the subsequent marketing of the
  Product, whether by DESITIN or DESITIN’s Affiliates or by local distribution
  partners, is likely to be profitable and commercially feasible, DESITIN will
  focus on France, Italy, Spain, the United Kingdom, Denmark, Sweden and
  Finland. Launch of the Product in the remaining countries of the Territory
  will be considered at a later stage and shall be mutually agreed.

  
	
   

  	
   

  	
   

  
	
  5.3

  	
   

  	
  DESITIN shall not be required to conduct any
  clinical or non-clinical trials, except only for one (1) study regarding
  bioequivalence of the Product provided that such study is required by a
  competent Regulatory Authority.

  
	
   

  	
   

  	
   

  
	
  5.4

  	
   

  	
  The Parties shall consult on an ongoing basis as
  to the preparation, filing, pursuit and maintenance of regulatory submissions
  under this Clause 5 and no such submission shall be made by DESITIN without
  ZOGENIX’s prior written approval, not to be unreasonably withheld. DESITIN
  shall keep ZOGENIX informed, in writing, of the status of its applications
  for Marketing Authorisations on a regular basis, and in any event no less
  frequently than once every three months, and shall immediately notify ZOGENIX
  in writing of any substantial change in the status of any Marketing
  Authorisation or any substantive questions received from any Regulatory
  Authority in respect of such Marketing Authorisations. DESITIN shall provide
  copies of all Marketing Authorisations to ZOGENIX at its request.

  



 


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  5.5

  	
   

  	
  Once Marketing Authorisation is granted in Germany
  without any qualifications, DESITIN hereby undertakes to ZOGENIX that it will
  Launch the Product in Germany no later than [***] ([***]) months after the
  date of the relevant Marketing Authorisation; provided
  that such time period shall be extended by the time period during which
  ZOGENIX fails to timely supply DESITIN with Product which has been properly
  ordered pursuant to the terms of the applicable supply agreement. Should
  DESITIN fail to Launch the Product in accordance with this Clause 5.5,
  DESITIN further undertakes to ZOGENIX that it will promptly notify ZOGENIX of
  such failure which shall be deemed a material breach of this Agreement

  
	
   

  	
   

  	
   

  
	
  5.6

  	
   

  	
  Once Marketing Authorisation is granted in any
  country of the Territory other than Germany without any qualifications,
  DESITIN shall (i) verify the profitability of a possible Launch of the
  Product in the respective country and (ii) subject to the verification
  of the profitability for such country in the Territory, Launch the Product as
  soon as reasonably practicable and commercially viable.

  
	
   

  	
   

  	
   

  
	
  5.7

  	
   

  	
  ZOGENIX shall use Reasonable Commercial Efforts to
  assist DESITIN to solve material issues which may arise after discussions
  with Regulatory Authorities on the Product.

  
	
   

  	
   

  	
   

  
	
  5.8

  	
   

  	
  ZOGENIX, to the extent it is legally and
  contractually permitted to so do, shall take all steps which may be required
  by law and shall sign all necessary documents and perform all commercially
  reasonable obligations which may be required in order to assure that DESITIN
  may market, sell and distribute the Product in the Territory under its own
  company name and in the manner it regards as appropriate subject to the terms
  of this Agreement and any possible restrictions caused by Marketing
  Authorisations.

  
	
   

  	
   

  	
   

  
	
  5.9

  	
   

  	
  The licences granted under Clauses 2.1 and 3.1 of
  this Agreement will become non-exclusive in the event that DESITIN
  (i) will not start the study regarding bioequivalence of the Product as
  referred to in Clause 5.3 within [***] ([***]) months following the receipt
  of the Licensed Know-How as of the Effective Date according to Clause 5.1 or
  (ii) has not filed a Marketing Authorisation for the Product in Germany
  within [***] ([***]) months after the completion of such bioequivalence study
  or (iii) otherwise adhere to a mutually agreed timeline for the
  execution of clinical trials and submissions of Marketing Authorisations
  throughout the Territory.

  
	
   

  	
   

  	
   

  
	
  5.10

  	
   

  	
  To the extent
  permissible by law, DESITIN is prohibited from advertising, circulating price
  lists or otherwise soliciting orders for the Product, and from establishing
  or maintaining branches, sales offices or distribution depots, outside the
  Territory for the distribution of the Product.

  
	
   

  	
   

  	
   

  
	
  6.

  	
   

  	
  MANUFACTURE AND SUPPLY OF THE PRODUCT

  
	
   

  	
   

  	
   

  
	
  6.1

  	
   

  	
  Clinical
  Supply.
  ZOGENIX shall be the exclusive supplier of all of DESITIN’s requirements for
  Clinical Trial Materials in the Territory at ZOGENIX’s Cost of Goods
  Manufactured. DESITIN shall purchase all of its requirements of Clinical
  Trial 

  



 


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  Materials in the
  Territory from ZOGENIX. Additional terms under which ZOGENIX shall supply
  Clinical Trial Materials in the Territory are set forth on Appendix 3.

  
	
   

  	
   

  	
   

  
	
  6.2

  	
   

  	
  Commercial
  Supply. The
  Parties shall use Reasonable Commercial Efforts to sign the Manufacturing
  Agreement no later than [***] ([***]) months prior to the anticipated first
  Launch of the Product in the Territory.  The Manufacturing Agreement shall contain the terms set forth in this
  Clause 6.2 through Clause 6.6 and such other commercially reasonable and customary terms
  and conditions to be mutually agreed by the Parties (including the right of
  DESITIN to audit ZOGENIX’s (or its Third Party contract manufacturer’s)
  manufacturing facilities and a forecasting mechanism which will permit
  ZOGENIX to properly manage its supply chain for the Product on a worldwide
  basis) and such other terms as are reasonable and customary in the commercial
  supply of pharmaceutical compounds; provided that the Manufacturing Agreement
  shall be subject to the terms of any manufacturing agreement which ZOGENIX
  puts into place with respect to the commercial supply of Product in the Other
  Territories

  
	
   

  	
   

  	
   

  
	
  6.3

  	
   

  	
  DESITIN acknowledges and agrees that ZOGENIX will
  manufacture the Product or will enter into a contractual relationship with
  one or several manufacturers of the Product. Such Third Party manufacturers
  shall be listed in the registration documentation and manufacture the Product
  on ZOGENIX’s behalf in accordance with applicable law in the Territory.

  
	
   

  	
   

  	
   

  
	
  6.4

  	
   

  	
  Any Products supplied by ZOGENIX hereunder shall
  be manufactured:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  in accordance
  with cGMP;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  in compliance
  with the Product Specification; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  in compliance
  with all applicable and relevant national and local laws, rules and
  regulations, including those promulgated by any relevant Regulatory
  Authority.

  
	
   

  	
   

  	
   

  	
   

  
	
  6.5

  	
   

  	
  The Product shall be supplied by ZOGENIX to
  DESITIN as finished products ready for final packing and labelling as
  required in each country of the Territory (DESITIN will be responsible for
  such items as set forth in Clause 7.3 as well as quality control, in each
  case at its own expense). Each shipment of the Product shall be accompanied
  by the corresponding analytical certificate attesting to the Product’s
  compliance with the specification approved by the Regulatory Authority in the
  Territory. The Product shall  be placed at DESITIN’s disposal EXW (Incoterms 2000) ZOGENIX’s
  manufacturing facility at such address as is notified to DESITIN from time to
  time in writing.

  
	
   

  	
   

  	
   

  
	
  6.6

  	
   

  	
  ZOGENIX shall deliver commercial supply of the
  Product to DESITIN in complete batch quantities whereby each batch shall have
  a minimum remaining shelf life of [***] percent ([***]%) of the shelf life
  approved by the United States Food and Drug

  



 


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  Administration in the Marketing Authorisation
  submitted by ZOGENIX on its own behalf.

  
	
   

  	
   

  	
   

  
	
  7.

  	
   

  	
  MARKETING

  
	
   

  	
   

  	
   

  
	
  7.1

  	
   

  	
  DESITIN shall inform
  ZOGENIX [***] ([***]) months before the anticipated date of the first Launch
  of the Product in the Territory of the Key Facts of its proposed promotion
  strategy regarding the Product. DESITIN shall provide ZOGENIX with copies of
  all promotional materials to be used in connection with the marketing and/or
  promotion of the Product in the Territory prior to their use. The materials
  shall be submitted in the language(s) of the country or countries where
  they are to be used. ZOGENIX shall use Reasonable Commercial Efforts to
  provide a written response, either approving or suggesting reasonable
  changes, within [***] ([***]) weeks of receipt of such Key Facts or
  promotional materials. If DESITIN does not receive a written response from
  ZOGENIX within this [***]-week period ZOGENIX shall be deemed to have given
  its approval. In case ZOGENIX does not agree with the provided Key Facts or
  other statements contained in any promotional materials, ZOGENIX and DESITIN
  agree to discuss the Key Facts or such other statements, as applicable, in
  good faith. After written approval by ZOGENIX which shall not be unduly
  withheld or delayed, DESITIN shall carry out marketing and promotional
  activities in relation to the Product in the Territory in compliance with the
  approved Key Facts, promotional materials and all applicable laws,
  rules and regulations.

  
	
   

  	
   

  	
   

  
	
  7.2

  	
   

  	
  During the Term, DESITIN shall not, and shall
  ensure that its Affiliates and permitted sub-licensees shall not, market,
  sell, promote or distribute the Product in the Other Territories.

  
	
   

  	
   

  	
   

  
	
  7.3

  	
   

  	
  DESITIN shall be
  responsible, at its cost, for  final
  packaging and labelling of Product in accordance with the requirements for
  each country of the Territory.

  
	
   

  	
   

  	
   

  
	
  7.4

  	
   

  	
  DESITIN shall be
  free to set any price for the Product in the Territory subject to discussion
  by the SC as provided in Clause 4.4 and applicable pharmaceutical regulations.

  
	
   

  	
   

  	
   

  
	
  7.5

  	
   

  	
  Except to the
  extent permitted by law and as may be agreed in writing between the Parties,
  DESITIN shall not market, sell, promote or distribute the Product in the
  respective country in the Territory unless and until DESITIN obtains the appropriate
  Marketing Authorisations in respect of such Product in the respective country
  in the Territory.

  
	
   

  	
   

  	
   

  
	
  8.

  	
   

  	
  PRICING

  
	
   

  	
   

  	
   

  
	
  8.1

  	
   

  	
  DESITIN shall purchase the Product for commercial
  sale from ZOGENIX at the greater of (a) the agreed Transfer Price as defined
  in Clause 8.3 or (b) Cost of Goods Manufactured (collectively, the
  “Purchase Price”). In the event that Purchase Price is greater than the
  higher of [***]€ or US$[***], DESITIN shall have the right to terminate this
  Agreement as set forth in Section 21.7.

  



 


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  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 15

  



 


	
  8.2

  	
   

  	
  Transfer Price shall be subject to adjustment on
  an annual basis beginning in 2009 based on data for the prior year (e.g.,
  increases for information reported for 2008 shall apply to 2009 Transfer
  Prices) as of May 31 beginning with May 31, 2009, in accordance
  with the annual percentage change in the European pricing index of industrial
  products (“Erzeugerpreise industrieller Produkte auf dem Inlandsmarkt -
  Gesamte Industrie ohne Baugewerbe - Eurozone”; Source: EUROSTAT), except as
  otherwise mutually agreed by the Parties.

  
	
   

  	
   

  	
   

  
	
  8.3

  	
   

  	
  The Transfer Price (EXW (Incoterms 2000)) shall be
  calculated according to the following table and subject to adjustment as set
  forth in Clause 8.2:

  



 




	
  Annual Units

  	
  Transfer Price

  (EUR)

  
	
  [***]

  	
  [***]

  
	
  [***]

  	
  [***]

  
	
  [***]

  	
  [***]

  






 


	
   

  	
   

  	
  By way of example, if DESITIN or its Affiliates
  were to purchase an aggregate of [***] units in a calendar year 2008, the
  total Transfer Price for such calendar year would be calculated as follows:
  ([***] x [***]€) + ([***] x [***]€) + ([***] x [***]€) = [***]€.

  
	
   

  	
   

  	
   

  
	
  9.

  	
   

  	
  ROYALTIES

  
	
   

  	
   

  	
   

  
	
  9.1

  	
   

  	
  DESITIN shall pay ZOGENIX a royalty equal to
  [***]% of the DESITIN’s Net Sales (“Royalty”).

  
	
   

  	
   

  	
   

  
	
  9.2

  	
   

  	
  Royalties will not be payable on sales realised by
  regional distributors or Third Parties so long as such sales have been
  included in DESITIN’s Net Sales upon first sale or distribution to such
  regional distributors or Third Parties or are otherwise invoiced directly by
  DESITIN and as a result included in DESITIN’s Net Sales.

  
	
   

  	
   

  	
   

  
	
  9.3

  	
   

  	
  No Royalties
  shall accrue on the disposition of the Product as Samples (promotional or
  otherwise), donations or for clinical trials, provided that such level of
  sampling or donations are generally consistent with industry standards and in
  any event after expiry  of [***] ([***]) months upon
  Launch does not exceed [***]% of the gross revenues of the Product in the
  Territory.

  
	
   

  	
   

  	
   

  
	
  9.4

  	
   

  	
  The obligation to
  pay a Royalty under Clause 9.1 for a Product shall continue throughout the
  Term.

  



 


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  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 16

  



 


	
  10.

  	
   

  	
  PAYMENT
  TERMS

  
	
   

  	
   

  	
   

  
	
  10.1

  	
   

  	
  DESITIN shall make any
  other payments than Royalties due under this Agreement in United States
  Dollars within [***] ([***]) days of receipt of the invoice for Product
  (which date shall be no earlier than the date of delivery of the
  Product).Invoices shall be sent via fax and by internationally recognized
  overnight courier to DESITIN’s address for notices hereunder.

  
	
   

  	
   

  	
   

  
	
  10.2

  	
   

  	
  All right, title and risk
  in the Product passes to DESITIN upon delivery of Product to DESITIN in
  accordance with this Agreement.

  
	
   

  	
   

  	
   

  
	
  10.3

  	
   

  	
  DESITIN agrees to make
  payments and written reports to ZOGENIX within [***] ([***]) days after the
  end of each calendar quarter covering all sales of the Product in the Field
  in the Territory by DESITIN, its Affiliates or permitted sub-licensees for
  which invoices were sent during such calendar quarter, each such written
  report stating for the period in question: (i)  for Product disposed of
  in the Territory by sale, the quantity and description of Product, (ii) 
  for Product disposed of in the Territory other than by sale, the quantity,
  description, and nature of the disposition, (iii)  the calculation of
  DESITIN’s Net Sales for such quarter and year-to-date DESITIN’s Net Sales;
  and (iv)  the calculation of the amount due to ZOGENIX for such quarter
  pursuant to Clause 9 on account of such DESITIN’s Net Sales. The information
  contained in each report under this Clause 10.3 shall be considered
  Confidential Information of DESITIN. Concurrent with the delivery of each
  quarterly report, DESITIN shall make the payment due ZOGENIX hereunder in
  United States Dollars for the calendar quarter covered by such report.

  
	
   

  	
   

  	
   

  
	
  10.4

  	
   

  	
  All amounts not paid to
  the other Party when due shall accrue interest daily at the lesser of an
  annual rate of (a) [***] or (b) [***].

  
	
   

  	
   

  	
   

  
	
  10.5

  	
   

  	
  All sums
  payable hereunder are expressed to be exclusive of VAT or other similar tax.
  Notwithstanding the foregoing, any income or other taxes on any monies
  payable to ZOGENIX which DESITIN is required by law to pay or withhold on
  behalf of ZOGENIX, shall be deducted by ZOGENIX from such monies due. DESITIN
  shall furnish ZOGENIX with proof of such payments. Any such tax required to
  be paid or withheld shall be an expense borne solely by DESITIN, and ZOGENIX
  may request reimbursement from DESITIN for any such amounts. DESITIN shall
  promptly provide ZOGENIX with a certificate or other documentary evidence to
  enable ZOGENIX to support a claim for a refund or a foreign tax credit with
  respect to any such tax so withheld or deducted by DESITIN. At ZOGENIX’s
  request, DESITIN shall reasonably cooperate to support any claim by ZOGENIX
  for such a refund or credit. The Parties will reasonably cooperate in
  completing and filing documents under the provisions of any applicable tax
  treaty or under any other applicable law, in order to enable DESITIN to make
  such payments to ZOGENIX without any deduction for withholding.

  



 


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  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 17

  



 


	
  11.

  	
   

  	
  RECORDS
  AND REPORTS

  
	
   

  	
   

  	
   

  
	
  11.1

  	
   

  	
  During the Term, DESITIN
  shall, and shall procure that its Affiliates shall, keep at its normal place
  of business full, complete, accurate and up to date records and books of
  account recording DESITIN’s Net Sales sufficient to ascertain the Royalties
  payable under this Agreement.

  
	
   

  	
   

  	
   

  
	
  11.2

  	
   

  	
  Upon no less than [***]
  ([***]) Business Days notice from ZOGENIX, DESITIN shall make such records
  and books of account available for audit during business hours to ZOGENIX or
  its nominee (but not more than [***] in any calendar year).

  
	
   

  	
   

  	
   

  
	
  11.3

  	
   

  	
  ZOGENIX shall be solely
  responsible for its costs and expenses in making any such audit and
  inspection unless ZOGENIX properly identifies a discrepancy in the Royalties
  paid in any calendar year from those properly payable under this Agreement
  for that calendar year of greater than [***]%, in which event DESITIN shall
  pay ZOGENIX’s reasonable cost incurred in connection with the audit and
  inspection, and promptly make good the deficit in the Royalty payments. Upon
  the expiration of [***] months from the end of any calendar year the
  calculation of Royalties payable with respect to such year shall be binding
  and conclusive, and DESITIN shall be released from any liability or
  accountability with respect to Royalties for such year.

  
	
   

  	
   

  	
   

  
	
  11.4

  	
   

  	
  All information disclosed
  by DESITIN, its Affiliates or its permitted sub-licensees pursuant to Clauses
  11.1 through 11.3 shall be deemed Confidential Information of DESITIN, its
  Affiliates or its permitted sub-licenses, as the case may be.

  
	
   

  	
   

  	
   

  
	
  11.5

  	
   

  	
  DESITIN shall advise ZOGENIX
  of any legislation, rule, regulation or other law (including but not limited
  to any customs, tax, foreign exchange or foreign trade, antimonopoly,
  pharmaceutical products or intellectual property law) which is in effect or
  which may come into effect in the Territory after the date of this Agreement
  and which may affect the importation of the Products into the Territory or
  the use of the Products or the protection of the Licensed Technology as soon
  as DESITIN received notice thereof or would otherwise reasonably be expected
  to have notice thereof.

  
	
   

  	
   

  	
   

  
	
  12.

  	
   

  	
  INFRINGEMENT
  OF RIGHTS BY THIRD PARTY

  
	
   

  	
   

  	
   

  
	
  12.1

  	
   

  	
  ZOGENIX shall have the
  first right, but not the obligation, to take action in respect of any
  infringement of the Licensed Technology in the Territory, including but not
  limited to, commencing any claim or proceedings for injunctive, compensatory
  or other remedies or relief (collectively “Remedies”)
  as may be necessary or desirable to prevent such infringement and preserve
  the Licensed Technology. DESITIN shall permit any such Remedies to be brought
  in its name if permitted or required by law. ZOGENIX may compromise or settle
  any of the Remedies in its sole discretion, provided that, ZOGENIX shall not
  make any settlement or compromise that adversely affects the interests of
  DESITIN in respect of the Product in the Territory without the prior consent
  of DESITIN, such consent not to be unreasonably withheld or delayed.

  



 


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  Licensing &
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  Page 18

  



 


	
  12.2

  	
   

  	
  In the event that ZOGENIX
  elects not to pursue any Remedies with respect to the Licensed Technology in
  the Territory within [***] ([***]) days after notice in writing from DESITIN
  requesting ZOGENIX to do so, DESITIN shall have the right, but not the
  obligation, to pursue Remedies against such Third Party infringer, provided
  that:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  DESITIN does not make any settlement or compromise that affects the
  interests of ZOGENIX in the Product without the prior written consent of
  ZOGENIX, such consent not to be unreasonably withheld or delayed; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  if ZOGENIX has commenced negotiations with such Third Party for
  discontinuance of the infringement within such [***] ([***]) day period,
  ZOGENIX shall have an additional [***] ([***]) day period to conclude its
  negotiations before DESITIN may pursue any Remedies under this Clause 12.2.

  
	
   

  	
   

  	
   

  	
   

  
	
  12.3

  	
   

  	
  In the event that either Party pursues the Remedies under clauses 12.1
  or 12.2:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  the other Party shall use
  all reasonable efforts to assist and cooperate with the Party pursuing such
  Remedies, including providing access to relevant materials, personnel,
  documents and other evidence; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  each Party shall bear its
  own costs and expenses relating to its pursuit of Remedies or in providing
  assistance and cooperation; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  any damages or other
  amounts awarded to either Party shall be distributed as follows:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (i)

  	
  to the Party that pursued
  the Remedies, to cover its legal costs and expenses incurred; and then

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (ii)

  	
  to the other Party, to
  cover its legal costs and expenses, if any, relating to the pursuit of such
  Remedies; and then

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (iii)

  	
  any remaining amount,
  after the deductions set out above shall be retained by DESITIN, except that
  ZOGENIX shall receive a portion equivalent to the Royalties it would have
  received under this Agreement if such remaining amount were deemed DESITIN’s
  Net Sales.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.

  	
   

  	
  INFRINGEMENT
  OF THIRD PARTY RIGHTS

  
	
   

  	
   

  	
   

  
	
  13.1

  	
   

  	
  In the event that a Third
  Party institutes or threatens to institute a patent, trade secret or other
  infringement proceeding against either Party or its Affiliates during the
  Term, alleging that its or their manufacture, use or sale of the Product in
  the Territory infringes the Third Party’s Intellectual Property Rights (a
  “Third Party Action”), each Party shall promptly notify the other of the
  Third Party Action with such details as it 

  



 


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  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 19

  



 


	
   

  	
   

  	
  has in its possession and
  the Parties shall promptly convene a meeting of the SC to discuss the best
  way to respond.

  
	
   

  	
   

  	
   

  
	
  13.2

  	
   

  	
  Upon receipt of any such
  notice the SC shall discuss the potential infringement and to the extent
  necessary attempt to agree on a course of action. Such course of action may
  include:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  obtaining an appropriate
  license from the Third Party;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  contesting any claim or
  proceedings brought by the Third Party; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  bringing a declaratory
  judgment action against such Third Party.

  
	
   

  	
   

  	
   

  	
   

  
	
  13.3

  	
   

  	
  ZOGENIX shall have the
  first right but not the obligation, to take any action agreed upon by the
  Parties in respect of the Third Party Action. 
  If within [***] days the Parties fail to agree upon an
  appropriate course of action through discussions of the SC, ZOGENIX may
  decide upon the course of action with respect to any Third Party Action and
  may commence such action or negotiate a license with such infringed Third
  Party.

  
	
   

  	
   

  	
   

  
	
  13.4

  	
   

  	
  Neither Party shall
  settle any Third Party Action relating to the Product if such settlement
  admits the invalidity or unenforceability of any of the Licensed Technology,
  except as agreed in writing between the Parties.

  
	
   

  	
   

  	
   

  
	
  13.5

  	
   

  	
  In the event that the SC
  determines that DESITIN is best positioned to commence any action in relation
  to or defence of the Third Party Action, DESITIN shall be entitled to credit
  up to [***]% of its reasonable costs and expenses (including legal and expert
  fees) or any Third Party royalties incurred against any royalty payment
  otherwise payable to ZOGENIX under this Agreement. In the event that no such
  royalty payments are payable by DESITIN under this Agreement at the time of
  the Third Party Action, up to [***]% of any reasonable costs and expenses or
  Third Party royalties incurred by DESITIN in connection with the Third Party
  Action shall be reimbursed by ZOGENIX on a Quarterly basis. In addition, in
  any such action which DESITIN commences as permitted by this Clause 13,
  DESITIN shall seek ZOGENIX’s consent prior to concluding any settlement
  agreement, which consent can be withheld in its sole discretion.

  
	
   

  	
   

  	
   

  
	
  13.6

  	
   

  	
  In any such Third Party
  Action, the Parties shall cooperate with each other in connection with any
  such claim, suit or proceeding and shall keep each other reasonably informed
  of any material developments in connection with any such claim, suit or
  proceeding, including providing access to relevant documents, material,
  personnel or other evidence.

  
	
   

  	
   

  	
   

  
	
  14.

  	
   

  	
  INDEMNIFICATION
  AND INSURANCE

  
	
   

  	
   

  	
   

  
	
  14.1

  	
   

  	
  ZOGENIX shall defend,
  indemnify and hold harmless DESITIN, its Affiliates and its and their
  officers, directors, employees, agents and contractors (“DESITIN Parties”) from and against any and all claims, actions, demands, losses,
  damages, costs and 

  



 


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  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 20

  



 


	
   

  	
   

  	
  reasonable expenses
  (including reasonable legal and expert fees) made or brought by Third Parties
  (“Claims”) arising from or in connection with:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  the personal injury or
  death caused by the defective design and/or manufacture of the Product when
  supplied to DESITIN by ZOGENIX or its designee; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  the breach of the
  warranties given by ZOGENIX under this Agreement, or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  the negligence of ZOGENIX
  Parties (as defined below) in the research, development, marketing,
  distribution, sale or use of the Product before the Effective Date both in or
  outside the Territory, or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  the negligence of ZOGENIX
  Parties in the research, development, marketing, distribution, sale or use of
  the Product following the Effective Date outside the Territory,

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  provided that, in each case, such Claims do not arise from the
  negligence or wilful default of the DESITIN Parties.

  
	
   

  	
   

  	
   

  
	
  14.2

  	
   

  	
  DESITIN shall defend,
  indemnify and hold harmless ZOGENIX, its Affiliates and its and their
  officers, directors, employees, agents and contractors (the “ZOGENIX Parties”) from and against any and all Claims arising from or in connection
  with:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  the development,
  marketing, distribution, sale or use of the Product in the Territory after
  the Effective Date;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  the negligence by DESITIN
  Parties in relation to the development, marketing, distribution, sale or use
  of the Product in the Territory after the Effective Date; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  the breach of the
  warranties given by DESITIN under this Agreement,

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  provided that, in each
  case, such Claims do not arise from the negligence or wilful default of the
  ZOGENIX Parties. For the avoidance of doubt DESITIN shall in no event be
  liable for any claims arising from or in connection with the infringement of Third
  Party Rights, particularly patents and trademarks, caused by the manufacture
  or composition of the Product or the use of the Trademark.

  
	
   

  	
   

  	
   

  
	
  14.3

  	
   

  	
  Each Party shall promptly
  provide the other Party with copies of all papers and official documents
  received in respect of any Claims and shall cooperate as reasonably requested
  by the other Party in the defence of any Claims.  The
  Party which is indemnifying the other Party hereunder shall have control of,
  and discretion in, the handling of the defense and/or settlement of any such
  Claim, including, without limitation, the selection of defense counsel;
  provided, however, that the indemnified Party may take any appropriate action
  necessary to preserve or avoid prejudice to its interests, or the interests
  of the indemnifying Party, in the event that (1) notice to the
  indemnifying Party cannot be given in 
  sufficient time for such Party to take action, or (2) the
  indemnifying Party, after prompt notice and inquiry from the indemnified

  



 













 


	
  Licensing &
  Distribution Agreement between Zogenix & Desitin as of March 14, 2008

  	
   

  	
  Page 21

  



 


	
   

  	
   

  	
  Party, fails to
  acknowledge its  obligation to
  indemnify the indemnified Party under this Clause 14.

  
	
   

  	
   

  	
   

  
	
  14.4

  	
   

  	
  Each Party shall
  maintain, at its own cost, comprehensive product liability insurance and
  general commercial liability insurance adequate to cover their respective
  obligations under this Agreement in such amount as the Parties customarily
  maintain with respect to its other products and which is reasonable and
  customary in the pharmaceutical industry in their respective territories for
  companies of comparable size and activities. Each Party shall maintain such
  insurance policy for not less than [***] ([***]) years following the expiry
  or termination of this Agreement. A certificate of insurance and any other
  documentation necessary to prove compliance with this provision will be
  provided to the other Party upon request.

  
	
   

  	
   

  	
   

  
	
  14.5

  	
   

  	
  TO THE FULL EXTENT PERMITTED
  BY LAW, APART FROM THE FOREGOING WARRANTIES AND INDEMNITY OR SUCH
  WARRANTIES OR INDEMNITY AS MAY BE CONTAINED WITHIN THE MANUFACTURING
  AGREEMENT, NEITHER PARTY MAKES ANY ADDITIONAL REPRESENTATIONS OR WARRANTIES
  AND HEREBY DISCLAIMS ALL WARRANTIES, REPRESENTATIONS, AND LIABILITIES,
  WHETHER EXPRESS OR IMPLIED, ARISING FROM CONTRACT OR TORT (EXCEPT FRAUD),
  IMPOSED BY STATUTE OR OTHERWISE, RELATING TO THE PRODUCTS AND/OR ANY LICENSED
  TECHNOLOGY, INCLUDING ANY WARRANTIES AS TO MERCHANTABILITY, FITNESS FOR
  PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.

  
	
   

  	
   

  	
   

  
	
  14.6

  	
   

  	
  IN NO EVENT WILL EITHER
  PARTY BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES, INCLUDING
  ANY LOSS OF PROFITS, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE
  POSSIBILITY OF SUCH DAMAGES.

  
	
   

  	
   

  	
   

  
	
  15.

  	
   

  	
  IMPROVEMENTS
  AND PATENTS

  
	
   

  	
   

  	
   

  
	
  15.1

  	
   

  	
  All right, title and
  interest in any Intellectual Property Right created, generated or arising in
  connection with the Product and any Improvement thereof, whether invented
  solely by ZOGENIX, DESITIN or jointly by the Parties, shall be solely owned
  by ZOGENIX.

  
	
   

  	
   

  	
   

  
	
  15.2

  	
   

  	
  Each Party shall promptly
  disclose to the other any Improvements developed during the Term, and all
  such Improvements shall be deemed to the fullest extent possible to be works
  made for hire exclusively for ZOGENIX, with ZOGENIX having sole ownership of
  such Improvements and the sole right to obtain and to hold in its own name
  patents, copyrights, or such other protection as ZOGENIX may deem appropriate
  to the subject matter, and any extensions or renewals thereof (though ZOGENIX
  is under no obligation to file any patent application, secure or maintain any
  patent or register any copyright). To the extent DESITIN or its Affiliates
  nonetheless maintain any rights in and to any Improvements, DESITIN and its
  Affiliates hereby assign, cede and grant to ZOGENIX all rights to possession
  of, and 

  



 


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  Page 22

  



 


	
   

  	
   

  	
  all right, title, and
  interest, including all patents and copyrights and the right to prepare and
  exploit derivative works, in such Improvements. DESITIN agrees to give
  ZOGENIX or any person designated by ZOGENIX at ZOGENIX’s expense, all
  assistance reasonably required to perfect the rights hereinabove defined,
  including the execution of documents and assistance or cooperation in legal
  proceedings.

  
	
   

  	
   

  	
   

  
	
  15.3

  	
   

  	
  In the event that either
  Party identifies any Third Party Intellectual Property Rights that in such
  Parties’ reasonably opinion would provide a commercial benefit to the
  Product, it shall promptly inform the Other Party of such Intellectual
  Property Rights through the SC and the Parties shall in good faith discuss
  whether they intend to license or acquire such Third Party rights. In the
  event a license in such Third Party Intellectual Property Right shall be
  taken, ZOGENIX shall negotiate and enter into such license including the
  right to sub-license its rights to DESITIN. Any sublicense of rights shall be
  set forth in a separate sub-license agreement to be entered into between
  DESITIN and ZOGENIX and shall include terms substantially similar to those
  contained in this Agreement; provided that DESITIN and ZOGENIX shall equally
  share all Third Party license fees incurred.

  
	
   

  	
   

  	
   

  
	
  15.4

  	
   

  	
  ZOGENIX shall, at its
  sole cost and expense, using patent attorneys of its choice, use Reasonable
  Commercial Efforts to file, prosecute and maintain the patents, patent
  obligations and other Intellectual Property Rights related to the Licensed
  Technology in the Territory. Any costs relating to the filing of these
  Intellectual Property Rights in the Territory shall be borne by ZOGENIX.

  
	
   

  	
   

  	
   

  
	
  15.5

  	
   

  	
  ZOGENIX shall, at its
  sole cost and expense, using trademark attorneys of its choice, use
  Reasonable Commercial Efforts to file, prosecute, maintain and enforce the
  Trademark in the Territory.

  
	
   

  	
   

  	
   

  
	
  16.

  	
   

  	
  RIGHT OF
  FIRST REFUSAL

  
	
   

  	
   

  	
   

  
	
  16.1

  	
   

  	
  ZOGENIX hereby grants to
  DESITIN for the Term the right of first refusal to in-license any Product
  line extensions (including new or additional therapeutic uses) which DESITIN
  desires to market in the Territory as set forth in this Clause 16 (the
  “ROFR”).

  
	
   

  	
   

  	
   

  
	
  16.2

  	
   

  	
  Following ZOGENIX’s decision to offer for license any Product line extension in
  the Territory,  ZOGENIX shall promptly inform DESITIN in all relevant detail of any
  such Product line extensions, thus giving DESITIN a meaningful basis for
  taking a decision on whether or not to exercise the ROFR.

  
	
   

  	
   

  	
   

  
	
  16.3

  	
   

  	
  For a period of no more
  than [***] ([***]) months after ZOGENIX has supplied DESITIN with the
  information referred to in Clause 16.2 (the “Review Period”) DESITIN may
  exercise the ROFR by providing written notice to ZOGENIX within the Review
  Period of DESITIN’s desire to exercise the ROFR. The Parties shall thereafter
  negotiate in good faith for a period of no longer than [***] ([***])
  additional months, the terms and conditions on which such Product line
  extension would be included within this Agreement, if at all. If the Parties
  are unable to reach agreement following the expiration of such additional
  [***] ([***])-month period, ZOGENIX 

  



 


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  shall thereafter be
  permitted to license any such Product line extension to a Third Party on
  terms no more favourable to such Third Party than those most recently offered
  by DESITIN.

  
	
   

  	
   

  	
   

  
	
  17.

  	
   

  	
  REGULATORY

  
	
   

  	
   

  	
   

  
	
  17.1

  	
   

  	
  DESITIN shall, at its sole cost, use Reasonable Commercial Efforts
  (without being required to use all available resources) to prepare, file,
  prosecute and maintain the Marketing Authorisations and other permits
  required for the commercialisation of the Product in the Territory.

  
	
   

  	
   

  	
   

  
	
  17.2

  	
   

  	
  Each Marketing Authorisation will be registered in DESITIN’s name.

  
	
   

  	
   

  	
   

  
	
  17.3

  	
   

  	
  DESITIN shall act as ZOGENIX’s consultant and representative towards
  the MOH and the other relevant authorities or third parties in connection
  with obtaining and maintaining the Marketing Authorisation for the Product in
  the Territory.

  
	
   

  	
   

  	
   

  
	
  17.4

  	
   

  	
  ZOGENIX undertakes and covenants to DESITIN that it will not during
  the Term apply for an additional Marketing Authorisation relating to the Product
  in the Territory nor will ZOGENIX during the Term apply for or otherwise seek
  the benefit of any substitute of the Marketing Authorisation.

  
	
   

  	
   

  	
   

  
	
  17.5

  	
   

  	
  ZOGENIX shall keep DESITIN fully informed of any changes to the
  Product which it reasonably believes might be relevant in relation to the
  Marketing Authorisation. ZOGENIX shall not discontinue the supply of the
  Product containing the previous specifications unless all requirements set by
  a Regulatory Authority in the Territory for the maintenance or the renewal of
  the Marketing Authorisation issued by it have been complied with.

  
	
   

  	
   

  	
   

  
	
  17.6

  	
   

  	
  DESITIN shall be  responsible,
  as the case may be, for obtaining reimbursement for the Product on behalf of
  ZOGENIX in the Territory. ZOGENIX shall assist DESITIN in obtaining
  reimbursement by providing all reasonable support and all Data as may be
  required by the relevant Regulatory Authority.

  
	
   

  	
   

  	
   

  
	
  18.

  	
   

  	
  PHARMACOVIGILANCE

  
	
   

  	
   

  	
   

  
	
  18.1

  	
   

  	
  The Parties shall use Reasonable Commercial Efforts to sign the
  Pharmacovigilance Agreement no later than [***] ([***]) months prior to the
  anticipated first Launch of the Product in the Territory.

  
	
   

  	
   

  	
   

  
	
  18.2

  	
   

  	
  If there is any inconsistency between this Agreement and the
  Pharmacovigilance Agreement the terms of this Agreement will prevail between the
  Parties to the extent of such inconsistency.

  
	
   

  	
   

  	
   

  
	
  19.

  	
   

  	
  EXCHANGE
  OF INFORMATION

  
	
   

  	
   

  	
   

  
	
  19.1

  	
   

  	
  DESITIN shall use the Dossier only during the Term and in furtherance
  of its rights and obligations under this Agreement.

  



 


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  19.2

  	
   

  	
  DESITIN undertakes to neither sell nor otherwise make available to any
  Third Party the Dossier or any part thereof without a previous written
  approval from ZOGENIX.

  
	
   

  	
   

  	
   

  
	
  19.3

  	
   

  	
  ZOGENIX will inform DESITIN promptly if the competent Regulatory
  Authority or any other competent authority gives notice to ZOGENIX or its
  Affiliates of any difficulties or delays regarding the grant of the Marketing
  Authorisation in the U.S.A. or of any further studies to be conducted by
  ZOGENIX to obtain Marketing Authorisation in the U.S.A.

  
	
   

  	
   

  	
   

  
	
  20.

  	
   

  	
  [Intentionally Omitted]

  
	
   

  	
   

  	
   

  
	
  21.

  	
   

  	
  TERM AND
  TERMINATION

  
	
   

  	
   

  	
   

  
	
  21.1

  	
   

  	
  The term of this Agreement
  will continue on a country-by-country basis until the greater of ten (10)
  years after the Launch or the expiration in such country of the last to
  expire Patent Right included in the Licensed Technology or Improvements
  licensed hereunder (the “Initial Term”).

  
	
   

  	
   

  	
   

  
	
  21.2

  	
   

  	
  After the Initial Term and
  only with respect to countries of the Territory where the Product has been
  successfully Launched, this Agreement shall be automatically renewed on a
  country-by-country basis by additional successive periods of [***] ([***])
  years unless it is terminated by either Party giving [***] ([***]) month’s
  prior written notice.

  
	
   

  	
   

  	
   

  
	
  21.3

  	
   

  	
  Either Party shall be
  entitled to terminate the Agreement if:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  the other Party commits a
  material breach under this Agreement and in the case of a breach which is
  capable of remedy fails to remedy it within [***] ([***]) days of receipt of
  notice from the first Party of such breach and of its intention to exercise
  its rights under this Clause;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  the other Party enters into
  insolvency or bankruptcy or is unable to pay its debts as they fall due, or a
  trustee or receiver or the equivalent is appointed to the other Party, or
  proceedings are instituted against the other Party relating to dissolution,
  liquidation, winding up, bankruptcy, insolvency or the relief of creditors,
  if such proceedings are not terminated or discharged within [***] ([***])
  days;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  any law, decree, or
  regulation is enacted within the Territory which would substantially impair
  or restrict (1) the terminating Party’s right to terminate or elect not
  to renew this Agreement as herein provided; (2) ZOGENIX’s right, title
  or interest in the Products or the Intellectual Property Rights therein;
  (3) as to DESITIN, DESITIN’s right to market and distribute the Products
  in accordance with this Agreement; or (4) as to ZOGENIX, ZOGENIX’s right
  to collect the Purchase Price or Royalties as set forth in this Agreement; or

  



 


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  (d)

  	
  an adverse event occurs
  which has substantially impaired the other Party’s ability to continue to
  perform its obligations hereunder and the other Party is unable to provide
  the terminating Party with adequate assurance of future performance.

  
	
   

  	
   

  	
   

  	
   

  
	
  21.4

  	
   

  	
  Either Party shall be
  entitled to terminate this Agreement with [***] ([***]) days written notice
  without any damage, legal redress or compensation due it if the continued
  development or marketing of the Product is no longer possible due to advice
  from a relevant Regulatory Authority or clinical review board in the
  Territory or due to serious adverse events caused by the Product anywhere in
  the world.

  
	
   

  	
   

  	
   

  
	
  21.5

  	
   

  	
  DESITIN shall be entitled to
  immediately terminate this Agreement with written notice and without any
  damage, legal redress or compensation due to ZOGENIX in case:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)                   a competent Regulatory
  Authority imposes therapeutic indications in the Territory not acceptable to
  DESITIN or require the Product to be marketed as generic drug in the
  Territory; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)                   the Regulatory Authorities
  in the Territory require more than one study regarding bioequivalence of the
  Product to obtain Marketing Authorisation.

  
	
   

  	
   

  	
   

  	
   

  
	
  21.6

  	
   

  	
  ZOGENIX shall be entitled to
  terminate this Agreement with thirty (30) days written notice without any
  damage, legal redress or compensation due to DESITIN in case:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)                   DESITIN in each of [***]
  consecutive calendar years (other than any partial calendar year in which the
  Product is first Launched) fails to meet at least [***]% of the mutually
  agreed sales forecasts provided that such shortfall is caused by
  circumstances within DESITIN’s reasonable control;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)                   DESITIN takes any act or
  step impairing the Intellectual Property Rights of ZOGENIX or does anything
  that might otherwise adversely affect the Intellectual Property rights of
  ZOGENIX (whether DESITIN’s act or challenge of ZOGENIX’s rights is in good
  faith) and, if the act or step is capable of remedy, fails to remedy it
  within thirty (30) days of receipt of notice from ZOGENIX of such act or step
  and of its intention to exercise its rights under this Clause 21.6; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)                   DESITIN ceases to carry on
  business in the marketing of pharmaceutical products in the Territory.

  
	
   

  	
   

  	
   

  	
   

  
	
  21.7

  	
   

  	
  DESITIN shall be entitled to
  terminate this Agreement with [***] ([***]) days’ prior written notice under
  the conditions set forth in Section 8.1. Following the effective date of
  such termination, ZOGENIX shall reimburse DESITIN for [***] percent ([***]%)
  of the Third Party costs incurred by DESITIN in connection with clinical
  development and regulatory approval of the Product in the Territory under
  this Agreement, upon receipt of reasonably detailed documentation supporting
  such costs and such other supporting documentation as ZOGENIX may reasonably
  request. In no event shall the amounts reimbursed DESITIN pursuant to this Section 21.7
  exceed US$[***].

  
					



 


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  22.

  	
   

  	
  CONSEQUENCES
  OF TERMINATION

  
	
   

  	
   

  	
   

  
	
  22.1

  	
   

  	
  On expiration or termination
  of the Agreement for any reason whatsoever, the License granted under this
  Agreement shall cease and DESITIN shall, and shall procure that its
  Affiliates and permitted sub-licensees shall:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  Cease to carry out any of
  the activities permitted by this Agreement (or any relevant sub-license
  agreement) and cease to use or exploit in any way the Licensed Technology;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  Refrain from using the
  Trademark; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  Continue to treat the
  Licensed Know-how and any other information provided by ZOGENIX as secret and
  confidential according to Clause 23 hereof.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  In addition, on expiration
  of the Agreement or termination of the Agreement by ZOGENIX pursuant to
  Clauses 21.3 or 21.6, DESITIN shall grant to ZOGENIX a perpetual, royalty
  free license to use any trademark which DESITIN used in the commercialization
  of the Product in the Territory in connection with subsequent
  commercialization of the Product in the Territory by or on behalf of ZOGENIX;
  provided, however, that such license shall not include a right for ZOGENIX to
  use the word DESITIN in any subsequent commercialization of the Product in
  the Territory.

  
	
   

  	
   

  	
   

  
	
  22.2

  	
   

  	
  DESITIN, its Affiliates and
  its permitted sub-licensees shall be entitled to continue to sell existing
  stocks of the Product in the Territory for a period of no longer than
  [***]([***]) months following the date of termination, provided that DESITIN
  pays ZOGENIX any Royalty payments due in respect of such sales in accordance
  with the provisions of this Agreement.

  
	
   

  	
   

  	
   

  
	
  22.3

  	
   

  	
  The termination or expiry of
  this Agreement shall not release either of the Parties from any liability
  which at the time of termination or expiry has already accrued to the other
  Party, nor affect in any way the survival of any other right, duty or
  obligation of the Parties which is expressly stated elsewhere in this
  Agreement to survive such termination or expiry.

  
	
   

  	
   

  	
   

  
	
  23.

  	
   

  	
  CONFIDENTIALITY

  
	
   

  	
   

  	
   

  
	
  23.1

  	
   

  	
  The Parties, their
  Affiliates and their respective employees, directors, officers, consultants
  and contractors shall keep and maintain as confidential any Confidential
  Information supplied by the other Party prior to the Effective Date or during
  the Term. The confidentiality and non-disclosure obligations contained in
  this Agreement shall not apply to the extent that such Confidential
  Information is:

  



 


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  (a)

  	
  at the time of disclosure by
  one Party to the other, in the public domain or otherwise publicly known;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  after disclosure by one
  Party to the other becomes part of the public domain, other than by breach of
  any obligation of confidentiality;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  information which the
  receiving Party can establish by documentary evidence was already in its
  possession at the time of receipt or was independently developed by the
  receiving Party; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  received from a Third Party
  who was lawfully entitled to disclose such information.

  
	
   

  	
   

  	
   

  	
   

  
	
  23.2

  	
   

  	
  Notwithstanding clause 23.1,
  the Party receiving Confidential Information may disclose such Confidential
  Information:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  to governmental or other
  regulatory agencies in order to file patent applications or prosecute such
  applications to grant, provided that, the disclosure is limited to the extent
  reasonably required; provided that this sub-clause (a) shall only be
  applicable to Confidential Information of DESITIN received by ZOGENIX as it
  relates to Licensed Technology; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  to government or other
  Regulatory Authorities in order to file or prosecute any applications for
  Marketing Authorisations or other permits reasonably required to research, develop,
  manufacture, use, distribution, sale or supply the Licensed Product, provided
  that the disclosure is limited to the extent reasonably required and is
  consistent with the rights of the Party under this Agreement; or

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  to the extent that such
  disclosure has been ordered by a court of law or directed by a governmental
  body or authority in an enforceable decision, provided that, the Confidential
  Information may be disclosed only to the extent so ordered or directed and
  wherever practicable, the Party that owns the Confidential Information has
  been given sufficient written notice in advance to enable it to seek
  protection or confidential treatment of such Confidential Information.

  
	
   

  	
   

  	
   

  	
   

  
	
  23.3

  	
   

  	
  Neither Party shall disclose
  any information about this Agreement without the prior written consent of the
  other. However, the Parties intend to announce the execution and delivery of
  this Agreement promptly following such execution and delivery pursuant to the
  form of press release attached to this Agreement as Exhibit 23.3.
  Consent shall not be required, however, for (a) disclosures to tax
  authorities or to bona fide potential sub-licensees, to the extent required
  or contemplated by this Agreement, provided, that in connection with such
  disclosure, each Party agrees to use its commercially reasonable efforts to
  secure confidential treatment of such information; (b) disclosures of
  information for which written consent has previously been obtained, or
  (c) information which had previously been publicly disclosed, including
  pursuant to the press release described above. Each Party shall have the
  further right to disclose the terms of this Agreement as required by
  applicable law, including the rules and 

  



 













 


	
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  regulations promulgated by
  the Securities and Exchange Commission and/or the regulatory
  bodies/authorities governing securities issues in foreign jurisdictions and
  to disclose such information to stockholders or potential investors as is
  customary, provided the disclosing Party provides to the other Party, to the
  extent practicable, a copy of the information to be disclosed and an
  opportunity to comment thereon prior to such disclosure, and, to the extent
  practicable, consults within a reasonable time in advance of the proposed
  disclosure with the other on the necessity for the disclosure and the text of
  the proposed release. Any copy of this Agreement to be filed with the
  Securities and Exchange Commission shall be redacted to the reasonable
  satisfaction of both Parties; provided, however, in the event that the
  Securities and Exchange Commission objects to the redaction of any portion of
  the Agreement after the initial submission, the filing Party shall inform the
  other Party of the objections and shall in good faith respond to the
  objections in an effort to limit the disclosure required by the Securities
  and Exchange Agreement, but in any event the filing Party shall be free to
  include any portions of the Agreement it deems necessary to respond to the
  objections in any future filings.

  
	
   

  	
   

  	
   

  	
   

  
	
  24.

  	
   

  	
  REPRESENTATIONS
  AND WARRANTIES

  
	
   

  	
   

  	
   

  	
   

  
	
  24.1

  	
   

  	
  ZOGENIX and DESITIN each
  warrant that, as of the Effective Date:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  it is a company duly
  organised and existing and has the power and authority to enter into this
  Agreement;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  it has obtained all
  corporate authorisations required to enter into and perform its obligations
  under this Agreement;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  there are no agreements
  between it and any Third Party that conflict with this Agreement;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  no consent, approval,
  authorization or order of any court or governmental agency or body or Third
  Party is required for the execution and delivery by it of this Agreement;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (e)

  	
  it has all rights necessary
  to perform its obligations under this Agreement, including the grant of
  rights by ZOGENIX hereunder; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (f)

  	
  this Agreement is valid and
  binding obligation enforceable against it in accordance with its terms and
  conditions.

  
	
   

  	
   

  	
   

  	
   

  
	
  24.2

  	
   

  	
  ZOGENIX warrants that, as of
  the Effective Date:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  to the best of ZOGENIX’s
  knowledge, the sale and use of the Product does not infringe the Intellectual
  Property Rights of any Third Parties in the Territory and no court
  proceedings or other proceeding for infringement of Intellectual Property
  rights have been brought against ZOGENIX with respect to the Product in the
  Territory;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  to the best of ZOGENIX’s
  knowledge, no Third Party is infringing or has infringed any of ZOGENIX’s
  Intellectual Property Rights in the Licensed Technology in the Territory or
  has misappropriated any of the Licensed Know How in the Territory.

  



 













 


	
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  25.

  	
   

  	
  FORCE
  MAJEURE

  
	
   

  	
   

  	
   

  
	
  25.1

  	
   

  	
  Neither Party shall be
  entitled to terminate this Agreement or shall be liable to the other under
  this Agreement for loss or damages attributable to any Force Majeure,
  provided the Party affected shall give prompt notice thereof to the other
  Party. The Party giving such notice shall be excused from such of its
  obligations hereunder for so long as it continues to be affected by Force
  Majeure.

  
	
   

  	
   

  	
   

  
	
  25.2

  	
   

  	
  If such Force Majeure
  continues unabated for a period of at least [***] ([***]) days, the Parties
  will meet to discuss in good faith what actions to take or what modifications
  should be made to this Agreement as a consequence of such Force Majeure in
  order to alleviate its consequences on the affected Party.

  
	
   

  	
   

  	
   

  
	
  26.

  	
   

  	
  NOTICES

  
	
   

  	
   

  	
   

  
	
  26.1

  	
   

  	
  Any notice or other document
  given under this Agreement shall be in writing in the English language and
  shall be given by hand or sent by internationally recognized overnight
  courier, by fax transmission to the address of the receiving Party as set out
  in Clause 26.3 below unless a different address or fax number has been
  notified to the other in writing for this purpose.

  
	
   

  	
   

  	
   

  	
   

  
	
  26.2

  	
   

  	
  Each such notice or document
  shall:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  if given by hand, be deemed
  to have been given when delivered at the relevant address;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  if sent by internationally
  recognized overnight courier, be deemed to have been given two
  (2) Business Days following delivery to such overnight courier; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  if sent by fax transmission,
  be deemed to have been given when transmitted provided that a confirmatory
  copy of such facsimile transmission shall have been given by hand or sent by
  internationally recognized overnight courier as set forth herein.

  
	
   

  	
   

  	
   

  	
   

  
	
  26.3

  	
   

  	
  The address for services of notices
  and other documents on the Parties shall be:

  



 


	
  To DESITIN

  	
   

  	
  To ZOGENIX

  
	
  Name:

  	
  Desitin Arzneimittel GmbH

  	
   

  	
  Name:

  	
  Zogenix, Inc.

  
	
  Attn.:

  	
  Dr. Martin Zentgraf

  	
   

  	
  Attn.:

  	
  Chief Financial Officer

  
	
  Address:

  	
  Weg beim Jänger 214

  22335 Hamburg, Germany

  	
   

  	
  Address:

  	
  11682 El Camino Real

  Suite 320

  San Diego, CA 92130,

  USA

  
	
  Fax:

  	
  0049 40 59 101 366

  	
   

  	
  Fax:

  	
  001 858 259 1166

  
	
  E-Mail:

  	
  zentgraf@desitin.de

  	
   

  	
  E-Mail:

  	
  dnassif@zogenix.com

  



 


*** Certain information on
this page has been omitted and filed separately with the commission.
Confidential treatment has been requested with respect to the omitted portions.


 













 


	
  Licensing &
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  27.

  	
   

  	
  ASSIGNMENT

  
	
   

  	
   

  	
   

  
	
  27.1

  	
   

  	
  Neither Party shall assign
  any of its rights or obligations under this Agreement to a Third Party
  without the prior written consent of the other, such consent not to be
  unreasonably withheld, conditioned or delayed. ZOGENIX may assign its rights
  and obligations under this Agreement, without the prior written consent of
  DESITIN, to any Third Party purchaser of all or substantially all of the
  assets or business to which this Agreement relates.

  
	
   

  	
   

  	
   

  
	
  27.2

  	
   

  	
  Either Party may at any time
  assign any of its rights under this Agreement to an Affiliate, provided
  however, that such Party remains fully liable for the performance of such Party’s
  obligations hereunder by such Affiliate; provided further that any rights
  assigned by DESITIN to an Affiliate shall be immediately reassigned to
  DESITIN or assigned to an Affiliate of DESITIN if the assignee ceases to be
  an Affiliate.

  
	
   

  	
   

  	
   

  
	
  27.3

  	
   

  	
  Either Party may at any time
  engage a contract research organisation to manage any non-clinical or
  clinical studies required under or in connection with the Marketing
  Authorisation process.

  
	
   

  	
   

  	
   

  
	
  27.4

  	
   

  	
  Any assignment in violation
  of this Clause 27 shall be null and void. This Agreement shall be binding on
  and shall inure to the benefit of the permitted successors and assigns of the
  Parties hereto.

  
	
   

  	
   

  	
   

  
	
  28.

  	
   

  	
  GENERAL
  PROVISIONS

  
	
   

  	
   

  	
   

  
	
  28.1

  	
   

  	
  The relationship of ZOGENIX
  and DESITIN established by this Agreement is of independent contractors, and
  nothing in this Agreement shall be construed: (1) to give either Party
  the power to direct or control the daily activities of the other Party, or
  (2) to constitute the Parties as principal and agent, partners, or otherwise
  as participants in a joint undertaking. ZOGENIX shall have no obligation or
  authority, express or implied, to exercise any control whatsoever over the
  employees or the business affairs of DESITIN. Except as specifically provided
  in this Agreement, DESITIN shall have no power or authority to make or give
  any representation or warranty or to incur any liability or obligation, or to
  waive any right, on ZOGENIX’s behalf.

  
	
   

  	
   

  	
   

  
	
  28.2

  	
   

  	
  Each of the Parties shall do
  execute and perform all such further acts, deeds documents and things as the
  other Party may reasonably require from time to time to give full effect to
  the terms of this Agreement.

  
	
   

  	
   

  	
   

  
	
  28.3

  	
   

  	
  Each Party shall pay its own
  costs, charges and expenses incurred in connection with the negotiation,
  preparation and completion of this Agreement.

  
	
   

  	
   

  	
   

  
	
  28.4

  	
   

  	
  This Agreement, its
  schedules and the agreements contemplated herein (particularly the
  Pharmacovigilance Agreement and the Manufacturing Agreement) set out the
  entire agreement and understanding between the Parties in respect of the
  subject matter of this Agreement and supersede any heads of agreement which
  shall cease to have any further force or effect.

  



 













 


	
  Licensing &
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  28.5

  	
   

  	
  No variation of this
  Agreement, including this Clause 28.5, shall be valid unless it is in writing
  and signed by or on behalf of both Parties.

  
	
   

  	
   

  	
   

  
	
  28.6

  	
   

  	
  If and to the extent that
  any provision of this Agreement is held to be illegal, void or unenforceable,
  such provision shall be given no effect and shall be deemed not to be
  included in this Agreement but without invalidating any of the remaining
  provisions of this Agreement.

  



 













 


	
  Licensing &
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  28.7

  	
   

  	
  This Agreement and the
  obligations of the Parties shall be governed by and construed in accordance
  with the substantive laws of England to the exclusion of the United Nations
  Convention on the International Sale of Goods.

  



 


	
  SIGNED for and by
  behalf of

  	
   

  	
   

  	
   

  	
   

  
	
  DESITIN
  Arzneimittel GmbH

  	
   

  	
  _/s/

  	
  Dr. Martin
  Zentgraf

  	
   

  	
  3/14/08

  
	
   

  	
   

  	
  Dr. Martin Zentgraf

  	
   

  	
  Date

  
	
   

  	
   

  	
  General Manager

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  _/s/

  	
  Dr. Harald Jainta

  	
   

  	
  3/14/08

  
	
   

  	
   

  	
  Dr. Harald Jainta

  	
   

  	
  Date

  
	
   

  	
   

  	
  Director Business
  Development

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SIGNED for and by
  behalf of

  	
   

  	
   

  	
   

  	
   

  
	
  ZOGENIX, INC.

  	
   

  	
  /s/ Roger L. Hawley

  	
   

  	
  3/14/08

  
	
   

  	
   

  	
  Roger L. Hawley

  	
   

  	
  Date

  
	
   

  	
   

  	
  CEO

  	
   

  	
   

  



 










 


	
  Licensing &
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  Page 33

  



 


Appendix
1


 


PRODUCT
SPECIFICATION


 


sumatriptan DosePro is a sterile, pre-filled, single-use, disposable,
needle-free subcutaneous delivery system delivering sumatriptan injection.  sumatriptan DosePro consists of the following
components: a gray plastic handle and snap-off tip, a green lever, and a glass
medication chamber that is pre-filled with 6 mg/0.5 mL sumatriptan injection.  Utilizing pressure from a compressed nitrogen
gas source in the handle, sumatriptan DosePro delivers the medication by
pushing it through a small, precise hole in the glass medication chamber.  The resulting stream of medication is
propelled through the skin and is delivered subcutaneously without a needle,
following a unique biphasic pressure profile.










 


	
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Appendix
2


 


LICENSED PATENTS


 


[***]


 


Nine (9) pages have been omitted pursuant to a request
for confidential treatment.


 


*** Certain information on this page has been
omitted and filed separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.










 


	
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Appendix
3


 


Clinical Supply Terms


 


Pursuant to the terms of this Appendix 3, ZOGENIX shall supply DESITIN
with its requirements for Clinical Trial Materials solely for use in clinical
trial activities in the Territory in support of Marketing Authorisation for the
Product in the Territory (“Development”). 
Clinical Trial Materials supplied by ZOGENIX shall be provided at the
prices set forth in Clause 8 of the Agreement or at such other transfer prices
as the parties may mutually agree.


 


DESITIN shall place its first order for Clinical Trial Materials no
later than [***] ([***]) months following the Effective Date, to be delivered
no later than additional [***] ([***]) months thereafter.  DESITIN shall place subsequent orders for
Clinical Trial Materials at least [***] ([***]) months prior to the desired
delivery date.   ZOGENIX will use Reasonable
Commercial Efforts to meet DESITIN’s requested quantities and delivery
dates.  ZOGENIX shall notify DESITIN of
the specific delivery date and quantity for each subsequent order no later than
[***] ([***]) months following receipt of DESITIN’s order by ZOGENIX.


 


DESITIN
acknowledges and agrees that ZOGENIX will manufacture Clinical Trial Materials
or will enter into a contractual relationship with one or several manufacturers
for the Clinical Trial Materials. Such Third Party manufacturers shall
manufacture Clinical Trial Materials on ZOGENIX’s behalf in accordance with
applicable law in the Territory.


 


Any
Clinical Trial Materials supplied by ZOGENIX hereunder shall be
manufactured:  (a) in accordance
with cGMP; (b) in compliance with the Product Specification; and (c) in
compliance with all applicable and relevant national and local laws, rules and
regulations, including those promulgated by any relevant Regulatory Authority.


 


Clinical Trial Materials shall be supplied by ZOGENIX to DESITIN as
finished products ready for final packing and labelling as required in each
country of the Territory (DESITIN will be responsible for such items as set
forth in Clause 7.3 of the Agreement as well as quality control, in each case
at its own expense). Each shipment of Clinical Trial Materials shall be
accompanied by the corresponding analytical certificate attesting to compliance
with the Product Specification. Clinical Trial Materials shall be placed at
DESITIN’s disposal EXW (Incoterms 2000) ZOGENIX’s manufacturing facility.


 


*** Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been requested with
respect to the omitted portions.


 













 


	
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Exhibit 23.3


 


Form of Press Release


 





 


Zogenix
Licenses European Development and Commercial Rights for 


sumatriptan DoseProTM to Desitin Pharmaceuticals, GmbH


 


SAN DIEGO, CA (March XX,
2008): 
Zogenix, Inc. (“Zogenix”), a private, specialty pharmaceutical company,
today announced that it has entered into a license agreement to grant exclusive
rights in the European Union to Desitin Pharmaceuticals, GmbH (“Desitin”) to
develop and commercialize Zogenix’s late stage, single use, needle-free product
candidate for migraine headache, sumatriptan DosePro. The product candidate,
that incorporates the Zogenix DosePro needle-free drug delivery technology, has
previously demonstrated bioequivalence to the Imitrex STATdose System®
(sumatriptan injection, GlaxoSmithKline) in a U.S. pivotal clinical trial and
compelling ease-of-use in a usability trial with migraine sufferers.  


 


Under the terms
of the agreement, Desitin will oversee, and be responsible for the expenses
related to, all clinical development, regulatory approvals and
commercialization efforts required to market and sell sumatriptan DosePro
across Europe.  Zogenix will be
responsible for the manufacture and supply of commercial product, and will
receive a transfer price payment on manufactured product and royalty payments
based on sales of the product upon commercialization.  Zogenix retains full commercial rights to
sumatriptan DosePro in the U.S., Canada, Asia and certain other countries.


 


Sales of
triptans, the class of drugs in which sumatriptan DosePro is expected to
compete, total approximately $550 million annually in the five major countries
of Europe: Germany, France, Italy, Spain, and the UK, according to IMS Health
MIDAS.  "Triptans remain the
standard of care in migraine treatment,” commented Dr. Stephen Farr, President
and Chief Operating Officer of Zogenix. 
“However, there remains a significant unmet medical need for more
effective, easy-to-use triptans that can deliver on the promise of providing
faster onset and more complete pain relief without the use of a needle.  Sumatriptan DosePro is designed to meet these
needs.”


 


“This license
agreement expands the potential reach for sumatriptan DosePro beyond the U.S.,
where, subject to regulatory approval, Zogenix is preparing to commercialize
sumatriptan DosePro ourselves,” said Roger Hawley, Chief Executive Officer of
Zogenix.  “In Desitin, we have chosen a
European partner that has a proven track record of successfully developing,
registering and commercializing central nervous system (CNS) products.  We look forward to seeing sumatriptan DosePro
advance through these steps and launch in the European marketplace.”


 













 


“This agreement
reflects the unique and well respected position Desitin holds in the European
CNS market.  We have the ability to both
move this product candidate through the European regulatory process and to
launch it with our CNS-focused sales representatives in more than nine
countries,” commented Dr. Martin Zentgraf, Desitin’s General Manager.  “This product candidate fits with our ongoing
commitment to develop improved products that address unmet medical needs in the
CNS market.  We are delighted to be
working with Zogenix and, subject to regulatory approval, look forward to
bringing this important product candidate to the market for the benefit of
patients.”


 


About Zogenix


 


Zogenix, Inc.,
with offices in Emeryville and San Diego, CA, is a private, specialty
pharmaceutical company with two proprietary product candidates in late-stage
development for the treatment of central nervous system disorders and pain. The
company's lead product candidate, sumatriptan DosePro (previously Intraject®),
enables needle-free subcutaneous delivery of sumatriptan for the treatment of
acute migraine. In December 2007, Zogenix submitted a New Drug Application with
the U.S. Food and Drug Administration for sumatriptan DosePro. Zogenix’s second
product candidate, ZX002, is a novel controlled release formulation of
hydrocodone for the treatment of chronic pain. This product candidate has
completed Phase 2 clinical trials, and the company anticipates initiating the
Phase 3 clinical program in the second half of 2008.  The company also plans to license the
patented DosePro drug delivery system to other companies.  For additional information, visit www.zogenix.com.


 


About Desitin


 


Desitin
Arzneimittel GmbH, based in Hamburg, Germany is an independent, private, fully
integrated, German pharmaceutical company focused on the development,
manufacturing and distribution of products for the treatment of central nervous
system disorders.  Desitin, with turnover
in 2005/2006 of over $100 million, is one of the leading European companies in
the field of epilepsy with additional expertise in Parkinson’s disease and
psychiatric disorders. With their pharmaceutical and clinical development
capabilities, the company develops innovative products such as
controlled-release and high-dose antiepileptics.  Desitin’s sales infrastructure offers
comprehensive coverage in Germany, Northern and Eastern Europe. The company
also has strategic partnerships with other companies covering nearly all of the
remaining countries in Europe.  For
additional information, visit  www.desitinpharma.com    


 


Bourne Partners,
Charlotte N.C., acted as financial advisors to Desitin on this transaction.


 













 


ZogenixTM,
DoseProTM and INTRAJECT® are trademarks of Zogenix, Inc.


Imitrex STATdose
System® is a registered trademark of GlaxoSmithKline.  


 


###


CONTACTS: 


Zogenix, Inc.


J.D. Haldeman, 


VP, Commercial
Strategy & 


Corporate
Communications


858.436.8595


jdhaldeman@zogenix.com  


 


Desitin
Pharmaceuticals GmbH


Dr. Harald
Jainta,


Director Business
Development


Jainta@desitin.de