Exhibit 10.1 


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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


Execution Copy 


LICENSE AND COMMERCIALIZATION AGREEMENT

by and between


JAVELIN PHARMACEUTICALS, INC.

and

THERABEL PHARMA NV


January 15, 2009






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


TABLE OF CONTENTS


	
 

	
 

	
 

	
 

	
 

	
 


	
1.

	
 

	
DEFINITIONS

	
 

	
1


	
 

	
 

	
 

	
 

	
 


	
2.

	
 

	
GRANT OF
 LICENSES

	
 

	
12


	
 

	
 

	
 

	
 

	
 


	
 

	
2.1.

	
 

	
License to
 Therabel

	
 

	
12


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.2.

	
 

	
Sublicensing

	
 

	
12


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.3.

	
 

	
Right of
 Reference

	
 

	
12


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.4.

	
 

	
No Other
 Rights

	
 

	
13


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.5.

	
 

	
Sale of
 Javelin Pharmaceuticals (U.K.) Limited

	
 

	
13


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.6.

	
 

	
Section
 365(n)

	
 

	
13


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.7.

	
 

	
Non-Competition

	
 

	
14


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
2.8.

	
 

	
[***]

	
 

	
14


	
 

	
 

	
 

	
 

	
 

	
 


	
3.

	
 

	
DECISION
 MAKING AND DISPUTE RESOLUTION

	
 

	
14


	
 

	
 

	
 

	
 

	
 


	
 

	
3.1.

	
 

	
Overview

	
 

	
14


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
3.2.

	
 

	
Joint
 Steering Committee

	
 

	
14


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
3.3.

	
 

	
Other
 Committees

	
 

	
16


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
3.4.

	
 

	
Elevation
 and Dispute Resolution

	
 

	
16


	
 

	
 

	
 

	
 

	
 

	
 


	
4.

	
 

	
REGULATORY
 SUBMISSION ACTIVITIES, COMMERCIALIZATION AND DEVELOPMENT

	
 

	
17


	
 

	
 

	
 

	
 

	
 


	
 

	
4.1.

	
 

	
Regulatory
 Submission Activities

	
 

	
17


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.2.

	
 

	
Regulatory
 Matters

	
 

	
18


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.3.

	
 

	
Adverse
 Events

	
 

	
19


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.4.

	
 

	
Product
 Label Changes

	
 

	
19


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.5.

	
 

	
Manufacture
 and Supply of Licensed Products

	
 

	
20





i






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.6.

	
 

	
Quality
 Agreement

	
 

	
20


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.7.

	
 

	
Commercialization
 in the Territory

	
 

	
20


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.8.

	
 

	
Phase IV and
 Publication Strategy

	
 

	
22


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
4.9.

	
 

	
Development

	
 

	
23


	
 

	
 

	
 

	
 

	
 

	
 


	
5.

	
 

	
CONSIDERATION

	
 

	
23


	
 

	
 

	
 

	
 

	
 


	
 

	
5.1.

	
 

	
Upfront
 Payments

	
 

	
23


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
5.2.

	
 

	
Milestones

	
 

	
23


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
5.3.

	
 

	
Royalties

	
 

	
25


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
5.4.

	
 

	
Matters
 Concerning Payments

	
 

	
27


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
5.5.

	
 

	
Interest

	
 

	
28


	
 

	
 

	
 

	
 

	
 

	
 


	
6.

	
 

	
COVENANTS

	
 

	
28


	
 

	
 

	
 

	
 

	
 


	
 

	
6.1.

	
 

	
Third Party
 Consents

	
 

	
28


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
6.2.

	
 

	
Confidentiality

	
 

	
29


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
6.3.

	
 

	
Compliance
 with Law

	
 

	
31


	
 

	
 

	
 

	
 

	
 

	
 


	
7.

	
 

	
REPRESENTATIONS
 AND WARRANTIES

	
 

	
32


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
7.1.

	
 

	
Representations
 and Warranties of Each Party

	
 

	
32


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
7.2.

	
 

	
Additional
 Representations and Warranties of Javelin

	
 

	
33


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
7.3.

	
 

	
Additional
 Representations and Warranties of Therabel

	
 

	
34


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
7.4.

	
 

	
No
 Inconsistent Agreements

	
 

	
34


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
7.5.

	
 

	
Disclaimer

	
 

	
34


	
 

	
 

	
 

	
 

	
 

	
 


	
8.

	
 

	
INTELLECTUAL
 PROPERTY

	
 

	
34


	
 

	
 

	
 

	
 

	
 


	
 

	
8.1.

	
 

	
Ownership

	
 

	
34


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.2.

	
 

	
Prosecution
 and Maintenance of Patent Rights and other IP Rights

	
 

	
35





ii






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.3.

	
 

	
Trademarks

	
 

	
36


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.4.

	
 

	
Enforcement
 of Technology Rights and Trademarks

	
 

	
37


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.5.

	
 

	
Third Party
 Claims

	
 

	
37


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.6.

	
 

	
Patent
 Marking

	
 

	
38


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.7.

	
 

	
No Implied
 Licenses

	
 

	
38


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
8.8.

	
 

	
Privileged
 Communications

	
 

	
38


	
 

	
 

	
 

	
 

	
 

	
 


	
9.

	
 

	
TERM AND
 TERMINATION

	
 

	
39


	
 

	
 

	
 

	
 

	
 


	
 

	
9.1.

	
 

	
Term

	
 

	
39


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
9.2.

	
 

	
Termination

	
 

	
39


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
9.3.

	
 

	
Change of
 Control

	
 

	
41


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
9.4.

	
 

	
Survival of
 Certain Obligations

	
 

	
42


	
 

	
 

	
 

	
 

	
 

	
 


	
10.

	
 

	
LICENSED
 PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE

	
 

	
42


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
10.1.

	
 

	
Indemnification
 by Javelin

	
 

	
42


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
10.2.

	
 

	
Indemnification
 by Therabel

	
 

	
42


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
10.3.

	
 

	
Procedure

	
 

	
42


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
10.4.

	
 

	
Insurance

	
 

	
43


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
10.5.

	
 

	
Liability
 Limitations

	
 

	
43


	
 

	
 

	
 

	
 

	
 

	
 


	
11.

	
 

	
MISCELLANEOUS

	
 

	
44


	
 

	
 

	
 

	
 

	
 


	
 

	
11.1.

	
 

	
Governing
 Law and Arbitration

	
 

	
44


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.2.

	
 

	
Force
 Majeure

	
 

	
44


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.3.

	
 

	
Additional
 Approvals

	
 

	
45


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.4.

	
 

	
Waiver and
 Non-Exclusion of Remedies

	
 

	
45


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.5.

	
 

	
Notices

	
 

	
45





iii






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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.6.

	
 

	
Entire
 Agreement

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.7.

	
 

	
Amendment

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.8.

	
 

	
Assignment

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.9.

	
 

	
No Benefit
 to Others

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.10.

	
 

	
Counterparts

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.11.

	
 

	
Severability

	
 

	
47


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.12.

	
 

	
Further
 Assurance

	
 

	
48


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.13.

	
 

	
Publicity

	
 

	
48


	
 

	
 

	
 

	
 

	
 

	
 


	
 

	
11.14.

	
 

	
Relationship
 of the Parties

	
 

	
48





iv






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


LICENSE AND COMMERCIALIZATION AGREEMENT


	
 

	
 


	
 

	
          This
LICENSE AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is entered into on
this 15th day of January, 2009 (the “Execution Date”), by and among Javelin
Pharmaceuticals, Inc., a Delaware corporation (“Javelin”) and Therabel Pharma
N.V., a limited liability company organized and existing under the laws of
the Netherlands, with registered seat at Takkebijsters 17, 4817BL Breda, the
Netherlands, registered with the Chamber of Commerce under number
332475990000 (“Therabel”). Javelin and Therabel may each be referred to
herein individually as a “Party” and collectively as the “Parties.”  


	
 

	
 


	
 

	
BACKGROUND


	
 


	
 

	
          Javelin
 has developed (and/or has received licenses to) certain pharmaceutical
 products which have uses or potential uses in the treatment and prevention of
 disease in humans. 


	
 

	
 


	
 

	
          Therabel
 is engaged in the commercialization of human pharmaceutical products. 


	
 

	
 


	
 

	
          Javelin
 and Therabel desire to collaborate on the commercialization of Javelin’s
 pharmaceutical products on the terms and conditions set forth in this
 Agreement. 


	
 

	
 


	
 

	
AGREEMENT


	
 


	
 

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








	
 

	
 


	
1.

	
DEFINITIONS. 


	
 

	
 


	
 

	
          1.1.
 “Affiliate(s)” means, with respect to an Entity, any
 Entity that controls, is controlled by, or is under common control with such
 first Entity. For purposes of this definition only, “control” means (a) to
 possess, directly or indirectly, the power to direct the management or
 policies of a Entity, whether through ownership of voting securities or by
 contract relating to voting rights or corporate governance, or (b) to own,
 directly or indirectly, more than fifty percent (50%) of the outstanding
 voting securities or other ownership interests of such Entity. 


	
 

	
 


	
 

	
          1.2. “Applicable Laws” means all
applicable
 statutes, ordinances, regulations, rules, or orders of any kind whatsoever of
 any Regulatory Authority or other governmental authority that may be in
 effect from time to time in the Territory. 


	
 

	
 


	
 

	
          1.3. “Assumed Agreements” has the
meaning set
 forth in Section 4.5. 





1






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          1.4. “Calendar Quarter” means
each of the three
 (3) consecutive month periods ending on March 31, June 30, September 30, and
 December 31. 


	
 

	
 


	
 

	
          1.5. “Calendar Year” means each
twelve (12)
 month period ending December 31st. 


	
 

	
 


	
 

	
          1.6. “Change of Control” means
any of the
 following: (a) the sale or disposition of all or substantially all of the
 assets of a Party to a Third Party, (b) the acquisition by a Third Party,
 other than an employee benefit plan (or related trust) sponsored or maintained
 by a Party or any of its Affiliates, of more than fifty percent (50%) of such
 Party’s outstanding shares of voting capital stock, (c) the appointment or
 election to the Board of Directors of a Party of members constituting a
 majority of such Board who were not appointed, approved or recommended for
 election by the Board of Directors as constituted immediately prior to the
 appointment or election of such majority, or (d) the merger or consolidation
 of a Party with or into another corporation, other than, in the case of (b)
 or (c) of this Section, an acquisition or a merger or consolidation of a
 Party in which holders of shares of such Party’s voting capital stock
 immediately prior to the acquisition, merger or consolidation have at least a
 majority of the ownership of voting capital stock of the acquiring Third
 Party or the surviving corporation in such merger or consolidation, as the
 case may be, immediately after the merger or consolidation. Notwithstanding
 the foregoing, a Change of Control shall not be deemed to occur on account of
 an initial public offering, the acquisition of securities of a Party by an
 institutional investor, or Affiliate thereof, that acquires a Party’s
 securities in a transaction or series of related transactions as a passive
 investment which does not affect the management of such Party, or a sale of
 assets, merger or other transaction effected exclusively for the purpose of
 changing the corporate domicile of a Party. 


	
 

	
 


	
 

	
          1.7. “COGS” means the direct
Manufacturing
 costs with respect to the Licensed Products as well as all costs with respect
 to the transportation of the Licensed Product to (and the delivery of the
 Licensed Product at) Therabel’s warehouse (or the warehouse of Therabel’s
 designee), determined in accordance with GAAP, consistently applied. For the
 avoidance of doubt, “COGS” shall not include the costs or charges associated
 with the distribution of the Licensed Product. 


	
 

	
 


	
 

	
          1.8. “Commercialization” means
any and all
 activities of importing (with the exception, however, of the importation of
 the Existing Inventory), marketing, promoting, distributing, offering for
 sale and selling a Licensed Product in the Field in the Territory, including
 for example pre-commercial launch market development activities conducted in
 anticipation of Regulatory Approval, such as preparing advertising and
 promotional materials, sales force training and all activities, interactions
 and correspondence with a Regulatory Authority regarding Phase IV clinical
 trials. For the avoidance of doubt, Commercialization includes
 pharmacovigilance activities and Promotion, but does not 





2






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
include
 Development, Regulatory Submission Activities or Manufacturing. When used as
 a verb, “Commercialize” means to engage in Commercialization. 


	
 

	
 


	
 

	
          1.9. “Commercialization Plan” has
the meaning
 set forth in Section 4.7.1. 


	
 

	
 


	
 

	
          1.10. “Commercially Reasonable
Efforts” means
 for each Party, the carrying out of obligations in a diligent and sustained
 manner using such efforts and resources normally used by a company in the
 same business with similar resources as a Party for a product owned by it or
 to which it has rights of the type it has hereunder, which is of similar
 market potential at a similar stage in its development or product life,
 taking into account, without limitation, issues of safety and efficacy,
 product profile, the proprietary position of the product, the regulatory
 environment and status of the product, and other relevant scientific factors,
 market conditions then prevailing, including the competitive environment (but
 without regard to other products being developed or commercialized by such
 Party outside of this Agreement), profitability, profitability expectations,
 the extent of market exclusivity, the cost and any other burden to have the
 product approved by any relevant Regulatory Authority or any other authority
 or to obtain reimbursement approvals, health economic claims, and other
 similar factors reasonably determined by the Party to be relevant. “Commercially
 Reasonable” as used herein shall be interpreted in a corresponding manner. 


	
 

	
 


	
 

	
          1.11. “Compound” means diclofenac
sodium having
 the chemical name [***]. 


	
 

	
 


	
 

	
          1.12. “Confidential Information”
means, with
 respect to a Party, all information (and all tangible and intangible
 embodiments thereof), which is controlled by such Party or otherwise related
 to such Party, and is disclosed by such Party to the other Party pursuant to
 this Agreement in writing, orally, electronically, visually or by other
 means, and is designated as confidential by the disclosing Party whether by
 means reasonably calculated to inform the other Party of the confidential
 nature of such information, prior to or at the time any such information is
 disclosed by the disclosing Party to the other Party. In addition, any
 technical information disclosed at a meeting of the JSC or any other
 committee established pursuant to this Agreement shall constitute
 Confidential Information unless otherwise specified. 


	
 

	
 


	
 

	
          1.13. “Contraindication Label
Change” shall mean
 [***]. 


	
 

	
 


	
 

	
          1.14. “Control” or
“Controlled” means, with respect to any intellectual property
 right of a Party, that the Party or its Affiliate owns or has a license to
 such intellectual property right, other than pursuant to this Agreement, and
 has the ability to grant access, a license, or a sublicense to such
 intellectual property right to the other Party as provided in this Agreement
 without violating an agreement with or other rights of any Third Party. 





3






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          1.15. “Development” means, to the
extent
 applicable, the development of new forms of the Licensed Product (i.e. any
 forms, including low dose forms, that are different from the form of the
 Licensed Product as currently Commercialized in the United Kingdom) for
 Commercialization in the Territory. When used as a verb, “Develop” means to
 engage in Development. 


	
 

	
 


	
 

	
          1.16. “Development Plan” means,
to the extent
 applicable, the comprehensive plan for Development. 


	
 

	
 


	
 

	
          1.17. “Dispute Resolution Panel”
shall mean the
 panel of experts to be appointed on a issue by issue basis and consisting of
 either (i) the Independent Financial Expert the Independent Regulatory and
 Reimbursement Expert and a third qualified independent expert (having a
 related background and/or knowledge relevant to the dispute) selected jointly
 by the Independent Financial Expert and the Independent Regulatory Expert and
 who shall act as chair of the panel or (ii) if expressly agreed to by the
 parties in writing such other expert(s) as jointly nominated by the Parties
 on a issue by issue basis. 


	
 

	
 


	
 

	
          1.18. “Dyloject Trademark” means
Dyloject®.
 


	
 

	
 


	
 

	
          1.19. “Effective Date” means the
date on which
 Javelin shall have received (i) all consents required by Section 6.1(i)
 hereof and (ii) all consents necessary to assign to Therabel (or Therabel’s
 designated Affiliate) the Assumed Agreements under Section 4.5 hereof on the
 terms, in all material respects, that the Assumed Agreements exist on the Execution
 Date. 


	
 

	
 


	
 

	
          1.20. “EMEA” means the Regulatory
Agency known
 as either the European Medicines Agency or the European Agency for the
 Evaluation of Medicinal Products, or a successor agency with responsibilities
 comparable to those of the European Medicines Agency or the European Agency
 for the Evaluation of Medicinal Products. 


	
 

	
 


	
 

	
          1.21. “Entity” means any natural
person,
 corporation, firm, general partnership, limited partnership, limited
 liability company or partnership, proprietorship, other business organization
 or entity, trust, union, association or governmental or regulatory authority.
 


	
 

	
 


	
 

	
          1.22. “European Economic Area”
means [***]. 


	
 

	
 


	
 

	
          1.23. “Existing
      Inventory” means
Javelin’s
 remaining inventory of the Licensed Product for sale in the Territory in its
 possession or under its control which
 was produced prior to the Effective Date and has a shelf life as of the
 Effective Date of at least [***]. The estimated quantities of
 such inventory are set forth in Schedule 4.5(C). 





4






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          1.24. “FD&C Act” means the
United States
 Federal Food, Drug, and Cosmetic Act, as amended, and the regulations
 promulgated thereunder. 


	
 

	
 


	
 

	
          1.25. “FDA” means the United
States Food and
 Drug Administration or any successor agency thereto. 


	
 

	
 


	
 

	
          1.26. “Field” means the
treatment, prevention,
 modulation or diagnosis of any disease, disorder or condition in humans. 


	
 

	
 


	
 

	
          1.27. “First Commercial Sale”
means, with
 respect to the Licensed Product and any country of the Territory, the first
 sale of such Licensed Product under this Agreement for use in the Field to a
 Third Party in such country, after such Licensed Product has been granted
 Regulatory Approval for use in the Field by the competent Regulatory
 Authorities in such country. 


	
 

	
 


	
 

	
          1.28. “First Subsequent Regulatory
Submission Plan”
 means the comprehensive country-by-country plan for the Regulatory Submission
 of the Licensed Product for the purposes of obtaining Regulatory Approval in
 [***] except for those countries described in the Initial Regulatory
 Submission Plan, detailing Therabel’s specific strategies and timelines for
 seeking marketing authorization, including the identification of countries in
 which Therabel desires not to commercialize the Licensed Products. 


	
 

	
 


	
 

	
          1.29. “Force Majeure” has the
meaning set forth
 in Section 11.2. 


	
 

	
 


	
 

	
          1.30. “GAAP” means generally
accepted accounting
 principles using the International Financial Reporting Standards (IFRS), as
 in effect from time to time in the Territory. 


	
 

	
 


	
 

	
          1.31. “Improvements” means (i)
all Know-How
 necessary or useful to manufacture, develop or commercialize any injectable
 form of the Compound combined with a solubilizing excipient, including
 without limitation any method of making such combination, any composition or
 formulations of such combination, or any method of using or administering
 such combination and (ii) all Patent Rights that cover or recite any
 injectable form of the Compound combined with a solubilizing excipient, any
 method of making such combination, any composition or formulations of such
 combination, or the method of using or administering such combination. 


	
 

	
 


	
 

	
          1.32. “Indemnified Party” has the
meaning set forth
 in Section 10.3. 


	
 

	
 


	
 

	
          1.33. “Indemnifying Party” has
the meaning set
 forth in Section 10.3. 


	
 

	
 


	
 

	
          1.34. “Independent Financial
Expert” shall mean
 a senior partner of an independent international accounting firm having
 relevant expertise with respect to the 





5






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
country in
 respect of which the dispute has arisen and having a related background
 and/or knowledge relevant to the dispute, as jointly appointed by the Parties
 or if the Parties fail to agree on the identity of the expert, as appointed
 by the arbitrational tribunal in accordance with Section 11.1. 


	
 


	
 

	
          1.35. “Independent Regulatory and
Reimbursement Expert”
 shall mean a reputed expert in the field of regulatory and reimbursement
 matters, having relevant expertise with respect to the country in respect of
 which the dispute has arisen and having related background and/or knowledge
 relevant to the dispute, as jointly appointed by the Parties on a issue by
 issue basis, or if the Parties fail to agree on the identity of the expert,
 as appointed by the arbitrational tribunal in accordance with Section 11.1. 


	
 

	
 


	
 

	
          1.36. “Infringement” has them
caning set forth
 in Section 8.4.1. 


	
 

	
 


	
 

	
          1.37. “Initial Regulatory Submission
Plan” means
 the comprehensive plan for the Regulatory Submission of the Licensed Product
 for the purpose of obtaining Regulatory Approval in [***], and other
 countries of the Territory as agreed by the JSC in accordance with Section
 4.1, which will then be considered, together with [***] as the “first wave
 countries”, detailing Therabel’s specific strategies and timelines for
 seeking marketing authorization. 


	
 

	
 


	
 

	
          1.38. “IP Owners” means any and
all Third
 Parties having proprietary interest in the Javelin Technology, including but
 not limited to Janssen Pharmaceutica NV, Shimoda Biotech (Proprietary) Ltd.,
 Farmarc Netherlands N.V. and Farmarc Netherlands Antilles. 


	
 

	
 


	
 

	
          1.39. “Javelin House Marks” has
the meaning set
 forth in Section 8.3.3. 


	
 

	
 


	
 

	
          1.40. “Javelin Improvements”
means Improvements
 that Javelin Controls as of the Effective Date or that comes into the Control
 of Javelin during the Term. 


	
 

	
 


	
 

	
          1.41. “Javelin Know-How” means
Know-How that
 Javelin Controls as of the Effective Date or that comes into the Control of
 Javelin during the Term, in, each case, to the extent necessary or useful in
 the Territory to Manufacture, Commercialize a Licensed Product or conduct the
 Regulatory Submission Activities, including without limitation any method of
 making a Licensed Product, any composition or formulations of a Licensed
 Product, or any method of using or administering a Licensed Product. 


	
 

	
 


	
 

	
          1.42. “Javelin Patent Rights”
means any Patent
 Right that Javelin Controls (including without limitation the patent rights
 listed in Schedule 1.42) as of the Effective Date or that comes into the
 Control of Javelin during the Term of this Agreement, in each case, to the
 extent such rights cover or recite a Licensed Product, any method of making a
 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


          Licensed
Product, any composition or formulations of a Licensed Product, or the method
of using or administering a Licensed Product. 


	
 

	
 

	
 


	
 

	
          1.43. “Javelin Technology” means
(i) the Javelin
 Know-How, (ii) the Javelin Patent Rights and (iii) the Javelin Improvements. 


	
 

	
 

	
 


	
 

	
          1.44. “JSC” has the meaning set
forth in Section
 3.2. 


	
 

	
 

	
 


	
 

	
          1.45. “Know-How” means all
inventions,
 discoveries, data, information (including scientific, technical or regulatory
 information), processes, methods, techniques, materials, technology, results,
 analyses, laboratory, pre-clinical and clinical data, or other know-how,
 whether or not patentable, including without limitation pharmacology,
 toxicology, drug stability, manufacturing and formulation methodologies and
 techniques, clinical and non-clinical safety and efficacy studies, marketing
 studies, absorption, distribution, metabolism and excretion studies. 


	
 

	
 

	
 


	
 

	
          1.46. “Licensed Formulation”
means any
 combination of the Compound and [***] that is covered by any claim in the
 Javelin Patent Rights that exist on the Effective Date. 


	
 

	
 

	
 


	
 

	
          1.47. “Licensed Product” means
any [***] that
 contains the Licensed Formulation either alone or in combination with one or
 more other active ingredients. For the avoidance of doubt and unless
 otherwise mutually agreed by the Parties, each in its sole discretion,
 “Licensed Product” excludes [***]. 


	
 

	
 

	
 


	
 

	
          1.48. “Manufacturing” means, as
applicable, all
 activities associated with the production, manufacture, processing, filling,
 finishing, packaging, labeling, shipping, and storage of the Compound or
 Licensed Product, including process validation, stability testing,
 manufacturing scale-up, pre-clinical, clinical and commercial manufacture and
 analytical development, product characterization, quality assurance and
 quality control, whether such activities are conducted by a Party, its
 Affiliates or a Third Party contractor of such Party. When used as a verb,
 “Manufacture” means to engage in Manufacturing. 


	
 

	
 

	
 


	
 

	
          1.49. “Net Sales” shall mean the
aggregate
 amount invoiced for sales of the Licensed Product by or on behalf of
 Therabel, its Affiliates, and/or any of its Sublicensees, in each case on an
 arms-length basis to a Third Party (other than a Third Party who is a Sublicensee
 or a Third Party that sells the Licensed Product on behalf of Therabel), less
 only the sum of the following: 


	
 

	
 

	
 


	
 

	
 

	
          (a)
 Customary trade, quantity, or cash discounts and non-affiliated brokers’ or
 agents’ commission actually allowed and taken which are not already reflected
 in the amount invoiced; 


	
 

	
 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 


	
 

	
 

	
          (b)
 Rebates, including but not limited to government mandated rebates, actually
 allowed; 


	
 

	
 

	
 


	
 

	
 

	
          (c)
 Amounts actually repaid or credited by reason of rejections or return or
 recalls; 


	
 

	
 

	
 


	
 

	
 

	
          (d)
 Any freight or other transportation costs, and insurance charges to the
 extent included in the invoice price and separately identified on the invoice
 or other documentation maintained in the ordinary course of business; 


	
 

	
 

	
 


	
 

	
 

	
          (e)
 Duties, tariffs, and all sales, pharmaceutical, excise and other taxes based
 directly on sales or turnover or delivery of Licensed Products under this
 Agreement (including VAT) to the extent included in the invoice price and to
 the extent such taxes are remitted to the applicable taxing authority; 


	
 

	
 

	
 


	
 

	
 

	
          (f)
 Invoiced amounts actually written off during the period covered by the
 relevant royalty report (even if they relate to sales made during prior
 periods); and/or 


	
 

	
 

	
 


	
 

	
 

	
          (g)
 A reasonable reserve for pharmaceutical taxes or other taxes or charges on
 sales or turnover or delivery of Licensed Products under this Agreement that
 are not included in the invoice price for the Licensed Product (but excluding
 corporate income tax) consistent with past practices, having the de facto effect of reducing the
 effective price received by Therabel (or its Affiliates or sublicensees) for
 such Licensed Products; 


	
 

	
 

	
 


	
 

	
 

	
provided
 that, the deductions in clauses (a) through (d) above shall be consistent
 with corresponding deductions taken by Therabel with respect to other
 products sold by Therabel. In the event that Javelin disputes Therabel’s Net
 Sales calculations, Javelin may invoke its audit right pursuant to Section
 5.4.1


	
 

	
 

	
 


	
 

	
 

	
Net Sales
 will be determined in accordance with GAAP, but only to the extent that the
 provisions of this Section 1.50 does not expressly deviate from the GAAP
 provisions. Without limiting the generality of the foregoing, sales at cost,
 transfers or dispositions of Licensed Product for charitable, promotional
 (including samples), pre-clinical, clinical, or regulatory purposes will be
 excluded from Net Sales, as will sales or transfers of Licensed Product among
 a Party and its Affiliates or Sublicensees.


	
 

	
 

	
 


	
 

	
          1.50. “Net Sales Price” means the
net sales
 price per unit of Licensed Product, calculated in accordance with the
 provisions set forth in Section 1.50. 


	
 

	
 

	
 


	
 

	
          1.51. “New Drug Application” or
“NDA” means any application corresponding
 to a New Drug Application filed with the FDA as described in 21 CFR § 





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314 for
 Regulatory Approval (not including pricing and reimbursement approval) in any
 country or regulatory jurisdiction. 


	
 


	
 

	
          1.52. “Patent Right” means any
and all (a)
 patent applications in the Territory, including, without limitation, all
 provisional applications, substitutions, continuations,
 continuations-in-part, divisions, renewals, and all patents granted thereon,
 (b) patents in the Territory, reissues, reexaminations and extensions or
 restorations by existing or future extension or restoration mechanisms,
 including, without limitation, supplementary protection certificates or the
 equivalent thereof, and (c) any other form: of government-issued right
 substantially similar to any of the foregoing. 


	
 

	
 


	
 

	
          1.53. “Pharmacovigilence
Agreement” has the
 meaning set forth in Section 4.3. 


	
 

	
 


	
 

	
          1.54. “Phase IV” in reference to
a clinical
 trial means a trial conducted for purposes of further characterizing and
 supporting the Licensed Product for marketing but not for purposes of seeking
 Regulatory Approval or otherwise fulfilling a requirement of a Regulatory
 Authority.


	
 

	
 


	
 

	
          1.55. “Promotion” means those
activities
 normally undertaken by a pharmaceutical company’s sales force to implement
 marketing plans and strategies aimed at encouraging the appropriate use of a
 particular prescription or other pharmaceutical product. 


	
 

	
 


	
 

	
          1.56. “Recipients” has the
meaning set forth in
 Section 6.2.1. 


	
 

	
 


	
 

	
          1.57. “Regulatory Approval” means
the approval
 and authorization of a Regulatory Authority in a country necessary to
 manufacture, distribute, sell or market a Licensed Product in that country,
 including, where required and in accordance with the Commercialization Plan,
 pricing and reimbursement approval. 


	
 

	
 


	
 

	
          1.58. “Regulatory Authority”
means any
 applicable national, regional, state or local regulatory agency, department,
 bureau, commission, council, or other governmental entity involved in the
 granting of Regulatory Approval for a Licensed Product in the Territory,
 including the EMEA. 


	
 

	
 


	
 

	
          1.59. “Regulatory Submissions”
means
 applications for Regulatory Approval, notification and other submissions made
 to or with a Regulatory Authority that are necessary or reasonably desirable
 to Manufacture or Commercialize the Licensed Product in the Field in a
 particular country, whether obtained before or after a Regulatory Approval in
 the country. Regulatory Submissions include, without limitation,
 investigational new drug applications, Mutual Recognition Process
 applications, post approval submissions required to maintain Regulatory
 Approvals, and amendments and 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
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supplements
 to any of the foregoing and their foreign counterparts, applications for pricing
 and reimbursement approvals, and all proposed labels, labeling, package
 inserts, monographs and packaging for the Licensed Product in the Territory. 


	
 

	
 


	
 

	
          1.60. “Regulatory Submission
Activities” means
 all activities performed by Therabel in the performance of any Regulatory
 Submission Plan for the Licensed Product in the Field in the Territory.
 Regulatory Submission Activities shall include, without limitation, all
 activities conducted for the purpose of filing for and obtaining Regulatory
 Approval in the Field in the Territory and, to the extent such is required
 for obtaining said Regulatory Approval, preclinical testing, test method
 development and stability testing, toxicology, formulation, process
 development, manufacturing scale-up, quality assurance/quality control,
 clinical studies, seeking Regulatory Approval and otherwise handling
 regulatory affairs, statistical analysis and report writing, all of the above
 performed pursuant to (and to the extent required under) the Regulatory Submission
 Plans with respect to the Licensed Product. Regulatory Submission Activities
 shall not include Manufacturing or Commercialization. 


	
 

	
 


	
 

	
          1.61. “Regulatory Submission
Plans” means the
 Initial Regulatory Submission Plan and the First and Second Subsequent
 Regulatory Submission Plans for the Regulatory Submission of the Licensed
 Product as approved by the JSC and as amended or updated, from time to time,
 but in no event less frequently than- once a year, in accordance with this
 Agreement. 


	
 

	
 


	
 

	
          1.62. “Relevant Laws” has the
meaning set forth
 in Section 9.2.4. 


	
 

	
 


	
 

	
          1.63. “Right of Reference” has
the meaning set
 forth in Section 2.3. 


	
 

	
 


	
 

	
          1.64. “Senior Management” of a
Party includes,
 at a minimum, each of the Chief Executive Officer, Chief Financial Officer,
 Head of Research and Development, Head of Marketing, Head of Business
 Development, General Counsel and President or Chief Operating Officer of the
 pharmaceutical business or division or, if a Party does not employ any of
 such persons under such titles, such employees having similar
 responsibilities or, if none such employees exist, any other senior
 executives of the relevant Party. 


	
 

	
 


	
 

	
          1.65. “Sublicense Income” means
all payments
 that Therabel or an Affiliate receives from a Third Party Sublicensee in
 connection with any grant of rights that includes the rights granted to
 Therabel under Section 2.1, including without limitation license fees,
 milestone payments, license maintenance fees and other payments in connection
 with said grant of rights, but specifically excluding royalties, the purchase
 price for Licensed Product, reimbursement of costs for patent prosecution and
 defense, and sale of equity at fair market value. 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          1.66. “Sublicensee” means an
Affiliate or Third
 Party that is granted a license, sublicense, covenant not to sue or other
 grant of rights under this Agreement pursuant to Section 2.2 of this
 Agreement. “Sublicense means an agreement or arrangement pursuant to which a
 sublicense or distribution right has been granted. 


	
 

	
 


	
 

	
          1.67.
 “Second Subsequent Regulatory Submission
 Plan” means the comprehensive country-by-country plan for the
 Regulatory Submission of the Licensed Product for the purposes of obtaining
 Regulatory Approval in [***], detailing Therabel’s specific strategies and
 timelines for seeking marketing authorization, including the identification
 of countries in which Therabel desires not to Commercialize the Licensed
 Products. 


	
 

	
 


	
 

	
          1.68.
 “Sued Party” has the meaning set forth in Section
 8.5.2.


	
 

	
 


	
 

	
          1.69.
 “Technology” means Know-How and Patent Rights.


	
 

	
 


	
 

	
          1.70.
 “Term” is defined in Section 9.1.


	
 

	
 


	
 

	
          1.71.
 “Territory” means [***]. 


	
 

	
 


	
 

	
          1.72.
 “Therabel Improvements” means all Improvements (if
 any) that are invented, conceived or developed solely by Therabel or its
 Sublicensees or jointly be the Parties, their Affiliates, Sublicensees or
 Third Parties acting on their behalf or by Therabel and any of its Affiliates
 or Sublicensees during the Term of this Agreement or, as applicable, during
 the term of any sublicense agreement hereunder. 


	
 

	
 


	
 

	
          1.73.
 “Therabel Know-How” means all Know-How (if any) that
 is invented, conceived or developed solely by Therabel or jointly by the
 Parties, their Affiliates or Third Parties acting on their behalf in each
 case in the course of such Party’s performance under this Agreement. 


	
 

	
 


	
 

	
          1.74.
 “Therabel Patent Right” means any Patent Right (if
 any) that claims Therabel Know-How. 


	
 

	
 


	
 

	
          1.75.
 “Therabel Technology” means Therabel’s interest in
 the (i) Therabel Know-How, (ii) the Therabel Patent Rights and (iii) Therabel
 Improvements, if any. 


	
 

	
 


	
 

	
          1.76.
 “Third Part(y/ies)” means any person(s) or entit(y/ies)
 other than Javelin and its Affiliates and Therabel and its Affiliates. 


	
 

	
 


	
 

	
          1.77.
 “Trademark” means any trademark under which the
 Licensed Product is sold, other than the Parties’ trade names and trademarks
 used by the Parties to identify their companies generally, including without
 limitation, the Dyloject Trademark. 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          1.78. “United States” or
“U.S.” means the
 United States of America, its territories and possessions (including Puerto
 Rico, irrespective of political status). 


	
 

	
 


	
 

	
          1.79. “Valid Claim” means a claim of a
 Patent Right in the Territory, which claim has not been revoked or held
 unenforceable, unpatentable or invalid by a decision of a court or other
 governmental agency of competent jurisdiction, which is not appealable or has
 not been appealed within the time allowed for appeal, and which has not been
 abandoned, disclaimed, denied or admitted to be invalid or unenforceable
 through reissue, re-examination or disclaimer or otherwise. 


	
 

	
 


	
 

	
          1.80. “Violating Party” has the meaning
 set forth in Section 9.2.4. 


	
 

	
 


	
2.

	
GRANT OF LICENSES. 


	
 

	
 


	
 

	
          2.1. License to Therabel. Subject to the
 terns and conditions of the Agreement, Javelin hereby grants to Therabel,
 effective on the Effective Date of the Agreement, an exclusive license, with
 the right to sublicense to its Affiliates or as expressly provided in Section
 2.2, under the Javelin Technology to develop, have developed, import, make,
 have made, use; offer to sell, sell, commercialize and distribute the
 Licensed Product in the Field in the Territory for the purpose of
 Manufacturing, seeking Regulatory Approval for and/or Commercializing
 Licensed Products in accordance with the terms of this Agreement. The
 exclusivity granted hereunder shall be absolute, meaning that Javelin shall
 not only refrain from granting further licenses (or appoint further sales
 intermediaries) with respect to the Licensed Product in the Territory, but
 also from selling, commercializing and distributing the Licensed Product in
 the Territory itself. Notwithstanding the foregoing, Javelin reserves the
 right under the Javelin Technology to develop and manufacture the Licensed
 Product in the Territory solely for commercialization outside the Territory. 


	
 

	
 


	
 

	
          2.2. Sublicensing. Therabel will have no
 right, except upon prior written consent of Javelin, which consent may not be
 unreasonably withheld, to grant sublicenses to Third Parties under the rights
 granted to Therabel under this Agreement. Any sublicenses granted by Therabel
 hereunder shall be consistent with the terms of this Agreement. In addition
 Therabel shall require any Sublicensee to transfer or convey to Javelin all
 Improvements and all Technology necessary or useful to make, use or sell a
 Licensed Product which such Sublicensee may develop or acquire, if any, so
 that any of such Technology will be Controlled by Javelin. 


	
 

	
 


	
 

	
          2.3. Right of Reference. Therabel hereby
 grants to Javelin (and any of Javelin’s partners and licensees) a “Right of
 Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the Field in
 the Territory to the data included in the Therabel Technology (if any) to the
 extent necessary or useful to Manufacture, Commercialize or Develop a
 Licensed Product in the Field throughout the world, subject to the terms and 





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conditions
 of this Agreement. The Parties agree that Javelin may make available to its
 collaborators, partners and licensees with respect to Licensed Products
 outside the Territory any Regulatory Submissions made in the Territory and
 data and results arising from clinical trials conducted by or on behalf of
 Therabel pursuant to this Agreement. The Parties agree that Therabel may make
 available to its collaborators, partners and sublicensees with respect to
 Licensed Products in the Territory any Regulatory Submissions made outside
 the Territory and data and results arising from clinical trials related to
 the Licensed Product conducted by or on behalf of Javelin. Therabel shall, at
 its own expense, take any action reasonably requested by Javelin to affect
 the Right of Reference described in this Section. 


	
 

	
 


	
 

	
          2.4. No Other Rights. No rights, other
 than those expressly set forth in this Agreement are granted to either Party
 hereunder, and no additional rights shall be deemed granted to either Party
 by implication, estoppel or otherwise. All rights not expressly granted by
 either Party to the other hereunder are reserved. 


	
 

	
 


	
 

	
          2.5. Sale of Javelin Pharmaceuticals (U.K.)
Limited.
 In view of facilitating the start-up of Therabel’s distribution and
 commercialization activities hereunder in the territory of the United
 Kingdom, Javelin and Therabel agree that Therabel shall take over Javelin’s
 existing United Kingdom distribution business (which consists of, among other
 things, the UK Marketing Authorization, the wholesalers license, employees
 and certain contracts in relation to existing marketing, sales, and
 distribution of the Licensed Product in the United Kingdom), by means of
 acquiring, upon the Effective Date, of 100% of the shares of capital stock of
 Javelin Pharmaceuticals (U.K.) Limited (“JPUK”). The terms and conditions of
 such acquisition shall be governed by the Share Purchase Agreement
 substantially in the form attached hereto as Exhibit 2.5 with such other
 changes as the Parties may agree to in good faith (the “Agreed SPA”).
 The Parties shall execute (and Javelin shall cause its Affiliate, Innovative
 Drug Delivery Systems Inc, to execute) the Agreed SPA within 15 days
 following the Execution Date and in any event prior to the Effective Date. In
 addition, until completion of the Agreed SPA in accordance with its terms,
 Javelin undertakes to cause that (i) JPUK’s business be continued to be
 operated in the ordinary course of business and in accordance with past
 practice, (ii) [***] and (iii) [***]. 


	
 

	
 


	
 

	
          2.6. Section 365(n). All rights and
 licenses granted under or pursuant to this Agreement by Therabel or Javelin
 are, and will otherwise be deemed to be, for purposes of Section 365(n) of
 the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as
 defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that
 the Parties, as licensees of such rights under this Agreement, will retain
 and may fully exercise all of their rights and elections under the U.S.
 Bankruptcy Code. The Parties further agree that, in the event of the
 commencement of a bankruptcy proceeding by or against either Party under the
 U.S. Bankruptcy Code, the Party hereto that is not a party to such proceeding
 will be entitled free of charge to a complete duplicate of (or 





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complete
 access to, as appropriate) any such intellectual property and all embodiments
 of such intellectual property, and same, if not already in their possession,
 will be promptly delivered to them (i) upon any such commencement of a
 bankruptcy proceeding upon their written request therefor, unless the Party
 subject to such proceeding elects to continue to perform all of its
 obligations under this Agreement, or (ii) if not delivered under (i) above,
 following the rejection of this Agreement by or on behalf of the Party
 subject to such proceeding upon written request therefor by the non-subject
 party. 


	
 

	
 


	
 

	
          2.7. Non-Competition. During the Term of
 this Agreement, neither Therabel nor any of its Affiliates shall, in or in
 relation to the Territory, develop, have developed, import, make, have made,
 use, offer to sell and/or sell any injectable non-steroidal anti-inflammatory
 drug for use in the Field in the Territory, except pursuant to the Agreement.
 During the Term of this Agreement, neither Javelin nor any of its Affiliates
 shall, in or in relation to the Territory, import, make, have made, use,
 offer to sell and/or sell any injectable non-steroidal anti-inflammatory drug
 for use in the Field in the Territory, except pursuant to the Agreement;
 provided that, the restrictions set forth in this sentence shall cease to
 have any effect following any Change of Control of Javelin. 


	
 

	
 


	
 

	
          2.8. [***]. 


	
 

	
 


	
3.

	
DECISION MAKING AND DISPUTE RESOLUTION. 


	
 

	
 


	
 

	
          3.1. Overview. During the Term, oversight
 for all of the activities of the Parties related to the Regulatory Submission
 Activities, the Commercialization and Development (if any) of the Licensed
 Product in the Field in the Territory will be provided by the JSC set forth
 below and elsewhere in this Agreement. The JSC shall perform the functions
 ascribed to them hereunder; provided, however, that the
 functions and operations of the JSC may be altered from time to time during
 the Term by the mutual agreement of the Parties to appropriately address
 ongoing requirements with respect to the Regulatory Submission Activities,
 the Commercialization and Development (if any) of the Licensed Product. In
 addition to the JSC meetings, the Parties anticipate that members of Senior
 Management from Therabel and Javelin will meet periodically as necessary or
 appropriate during the Term (and in any event at least [***]) in order to
 review significant issues and developments with respect to the Regulatory
 Submission Activities, the Commercialization and Development (if any) of the
 Licensed Product in the Territory. 


	
 

	
 


	
 

	
          3.2. Joint Steering Committee. The
 Parties will establish a joint steering committee (“JSC”) that will
 oversee the Regulatory Submission Activities, the Commercialization and
 Development (if any) of the Licensed Product in the Field in the Territory.
 The JSC will oversee the Regulatory Submission Activities of the Licensed
 Product in the Field in the Territory, the selling and marketing efforts
 under the Commercialization Plan and will serve as a forum for exchanging data,
 information and 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
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strategy
 regarding the Regulatory Submission Activities, the Commercialization and
 Development (if any) of the Licensed Product in the Field in the Territory.
 The JSC will have no other tasks and responsibilities than those as ascribed
 to them hereunder. 


	
 

	
 


	
 

	
                    3.2.1.
 Composition. The JSC will consist of three (3) senior representatives
 from each Party. Javelin and Therabel will each designate a co-chair for the
 JSC. The co-chairs will be responsible for logistical issues related to such
 meetings, but will not otherwise have any greater power or authority than any
 other member of the JSC. Responsibility for facilitating and calling
 meetings, setting meeting agendas, and producing and distributing meeting
 minutes shall alternate between the co-chairs on an annual basis. JSC members
 shall have such expertise as appropriate to the activities of the JSC from
 time to time and the JSC shall invite personnel of the Parties having
 relevant functional expertise to participate in discussions of the JSC from
 time to time as appropriate to assist in the activities of the JSC. 


	
 

	
 


	
 

	
                    3.2.2.
 Responsibilities. The JSC will be responsible for (i) approving the
 Regulatory Submission Plans for the Licensed Product in accordance with the
 terms of this Agreement, and any amendments to such plans, (ii) approving (or
 establishing procedures to approve) protocols for clinical studies (if any),
 (iii) supervising the quarterly monitoring of progress of clinical studies
 (if any) and additional studies of the Licensed Product (if any), (iv)
 reviewing and commenting on Regulatory Submissions relating to the Licensed
 Product prior to submission, (v) facilitating the exchange of all data,
 information, material or results relating to the development. of the Licensed
 Product, (vi) approving the strategy for the Commercialization of the
 Licensed Product in the Field in the Territory, in accordance with the terms
 of this Agreement, (vii) approving the Commercialization Plan for the Licensed
 Product in the Field in the Territory in accordance with the terms of this
 Agreement, as well as any updates thereof (to reflect materially changed
 circumstances), (viii) overseeing the implementation of the Commercialization
 Plan, (ix) establishing usage instructions for the Trademarks in accordance
 with the terms of this Agreement, (x) reviewing Therabel’s marketing and
 promotional activities to ensure that such activities are consistent with the
 Commercialization Plan, (xi) approving the Development Plan (if any) and
 overseeing the Development activities (if any) and (xii) such other
 responsibilities as are explicitly delegated to the JSC in this Agreement.
 The JSC may appoint additional committees as desired. Under no circumstances
 shall the JSC have any tasks or responsibilities other than those provided
 herein or as expressly agreed upon between the Parties in writing. Javelin
 shall report [***] to the JSC all progress made in respect of clinical
 studies and additional studies of the Licensed Product made or prepared by or
 under the control of Javelin (or its licensees or designees) outside of the
 Territory, which reports shall be Confidential Information of Javelin. 


	
 

	
 


	
 

	
                    3.2.3.
 No new obligations. For the avoidance of any doubt, it is expressly
 stated that the JSC, in fulfilling its tasks and responsibilities hereunder,
 shall 





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have no
 authority (i) to create any obligation incumbent on either Party hereunder
 that goes beyond the scope of the obligations expressly provided for herein
 or (ii) to construe any existing obligations in such a way that it exceeds
 the scope of the obligations expressly provided for herein. 


	
 

	
 


	
 

	
                    3.2.4.
 Meetings. The JSC will meet at such frequency as shall be established
 by the Parties (but not less frequently than [***] times per [***]). The
 first meeting of the JSC shall occur within [***] days of the Execution Date
 of this Agreement. Meetings of the JSC shall alternate between the offices of
 the Parties, unless otherwise agreed upon by the members of the JSC, or may
 be held telephonically or by video conference. Meetings of the JSC shall be
 effective only if at least [***] representatives of each Party are in
 attendance or participating in the meeting. Members of the JSC shall have the
 right to participate in and vote at meetings by telephone, or in their
 absence, to deputize another member of such Party’s Senior Management to vote
 on their behalf. If there is no quorum at any duly convened JSC meeting (i.e.
 at least [***] representatives of each Party being present), all agenda items
 of such JSC meeting requiring a vote shall automatically be considered as
 deadlock matters and shall be subject to Section 3.4. Each Party shall be
 responsible for expenses incurred by its employees and its members of the JSC
 in attending or otherwise participating in JSC meetings.


	
 

	
 


	
 

	
                    3.2.5.
 Minutes and Agendas. The minutes of each JSC meeting shall provide a
 description in reasonable detail of the discussions held at the meeting and a
 list of any actions, decisions or determinations approved by the JSC. Minutes
 of each JSC meeting shall be approved or disapproved, and revised as
 necessary, at the next meeting. 


	
 

	
 


	
 

	
                    3.2.6.
 No Joint Venture. For the avoidance of any doubt, it is expressly
 stated that the sole purpose of the JSC is to provide for an efficient means
 of communication between the Parties and that nothing ‘contained in the
 Agreement shall imply the JSC to constitute a legal entity or a joint venture
 between the Parties. 


	
 

	
 


	
                    3.3.
Other Committees. The Parties may
 establish other committees or subcommittees as the Parties deem appropriate. 


	
 

	
 


	
 

	
          3.4. Elevation and Dispute Resolution.
 Each Party’s representatives on the JSC will collectively have one (1) vote
 on all matters. The members of the JSC will use reasonable efforts to reach
 consensus on all decisions. In the event of a deadlock regarding a particular
 issue on which the members of the JSC cannot reach consensus, such issue will
 be resolved as follows: 


	
 

	
 


	
 

	
          In
 the event that the members of the JSC are unable to agree on a particular
 issue, such issue shall be referred to the Parties’ respective Chief
 Executive Officers or their designees for resolution, and such individuals
 shall use good faith efforts to resolve such 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 


	
 

	
issue within
 [***] days of such matter being referred to them, which period may be
 extended by mutual agreement. If the Chief Executive Officers or their
 designees are unable to resolve any matter referred to them within such
 [***]-day period, as it may be extended, then such matter will be resolved as
 follows: 


	
 

	
 


	
 

	
          (a)
 all matters relating to [***], shall be determined by Therabel, it being
 understood however that the decision with respect to the following matters
 shall be finally decided as follows: 


	
 

	
 


	
 

	
 

	
          (i)
 Each matter regarding [***] shall be finally decided by the Dispute
 Resolution Panel, in accordance with the criteria as indicated in Sections
 4.1.2 (a) and 4.7.2 below; and 


	
 

	
 

	
 


	
 

	
 

	
          (ii)
 Each matter regarding [***], shall be finally decided by the Dispute
 Resolution Panel, in accordance with the following criteria: [***]; 


	
 

	
 

	
 


	
 

	
          (b)
 except as set forth in Sections 3.4(a)(i) or (ii) or as set forth below, all
 matters relating to [***], including, without limitation, [***], shall be
 determined by Therabel. Notwithstanding the foregoing, (i) matters relating
 to [***] shall be finally decided by the Dispute Resolution Panel and (ii)
 Javelin shall have the final approval of any [***]. 


	
 

	
 


	
 

	
          (c)
 except as set forth in Sections 3.4(a)(i) or (ii), all matters relating to
 [***] shall be determined by the Javelin in accordance with Section 4.9; provided
 that Therabel shall not be bound by any decision by Javelin in this
 respect and shall not be under an obligation to proceed with [***] if [***]. 


	
 

	
 


	
4.

	
REGULATORY SUBMISSION ACTIVITIES, COMMERCIALIZATION AND DEVELOPMENT. 


	
 

	
 


	
 

	
          4.1. Regulatory Submission Activities 


	
 

	
 


	
 

	
                    4.1.1.
 Regulatory Submission Plans. Therabel shall (i) within [***] days of
 the Effective Date of this Agreement, present the [***] to the JSC for
 approval and (ii) within [***] days of the notice of the receipt of approval
 of the marketing authorization in the [***] (as set forth in the [***]),
 present the [***] to the JSC for approval, and (iii) within [***] of the
 Effective Date of the Agreement, present the [***] to the JSC for approval.
 Neither the [***] nor the [***] shall be effective until approved by the JSC.
 The Parties agree that it is their intent that Therabel shall seek Regulatory
 Approval for the Licensed Product throughout the Territory as soon as
 Commercially Reasonable, but without prejudice to [***] as referred to in
 (i), (ii) and (iii) hereinabove and subject to the other provisions of this
 Agreement. 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
                    4.1.2.
 In the event the JSC does not approve the [***], the [***] or the [***]
 proposed by Therabel (subject to Subsection (c) below), Therabel shall
 promptly provide to the JSC for its approval a revised plan that incorporates
 the reasonable comments and feedback from the JSC. The JSC will oversee the
 [***] of the Licensed Product in the Field in the Territory, according to the
 [***]. The following provisions shall apply with respect to the [***] of the
 Licensed Product: 


	
 

	
 


	
 

	
                    (a)
 The [***] for the Licensed Product will include, among other things, [***]. 


	
 

	
 


	
 

	
                    (b)
 [***]. 


	
 

	
 


	
 

	
                    (c)
 [***]. 


	
 

	
 


	
 

	
                    (d)
 [***]. 


	
 

	
 


	
 

	
                    4.1.3.
 Reports of [***]. Therabel shall report on the [***] it has undertaken
 in accordance with [***] in connection with meetings of the JSC, including by
 providing a reasonably detailed summary of all results, data and material
 inventions, if any, obtained from such activities. In addition, Therabel
 shall, at its own expense, make appropriate scientific and regulatory
 personnel available to the JSC, either by telephone or in person as the
 Parties may mutually agree, as reasonably required to keep informed of [***],
 in all material respects. 


	
 

	
 


	
 

	
          4.2. Regulatory Matters.


	
 

	
 


	
 

	
                    4.2.1.
 Responsibility for [***]. All activities and costs required to affect
 the [***] shall be the responsibility of Therabel, which may request the
 assistance of Javelin as required and shall keep Javelin reasonably informed
 of the status and progress. 


	
 

	
 


	
 

	
                    4.2.2.
 Responsibility for other Regulatory Interactions. Regulatory strategy
 for the Licensed Product shall be determined by the Regulatory Submission
 Plans. Therabel shall use Commercially Reasonable Efforts to prepare and
 maintain all Regulatory Submissions and any other documents required to be
 submitted to the applicable Regulatory Authorities and obtain in a timely
 manner Regulatory Approvals with respect to the Licensed Product, to the
 extent contemplated by the Regulatory Submission Plans. The costs incurred by
 Therabel in carrying out their assigned responsibilities pursuant this
 Section 4.2.2 shall be the sole responsibility of [***]. 


	
 

	
 


	
 

	
                    4.2.3.
 Regulatory Cooperation. Therabel shall keep Javelin reasonably
 informed regarding the status and progress of regulatory activity in the
 Territory in all material respects, including without limitation, providing
 Javelin with a copy of all substantive written correspondence from a
 Regulatory Authority involving a Regulatory Submission, notifying Javelin of
 all oral substantive correspondence from a Regulatory 





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BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
Authority
 involving a Regulatory Submission, and providing the JSC with an advance
 draft of each proposed Regulatory Submission sufficiently in advance of
 providing the submission to the Regulatory Authority (and in any event no
 less than [***] days in advance) to enable the JSC to have a meaningful
 opportunity to provide comments on the content of such submission and no such
 Regulatory Submission shall be submitted for filing with the Regulatory
 Authority without the mutual agreement of the Parties, such consent not to be
 unreasonably withheld or delayed. In the event that Javelin does not provide
 written comments within [***] days on any draft Regulatory Submission
 submitted to it by Therabel for comment, Javelin shall be considered as
 having approved said documents. Furthermore, the Parties shall agree in
 advance on all substantive written communications with Regulatory Authorities
 in the United Kingdom to the extent related to the Licensed Product. Each
 Party shall bear its own costs and expenses incurred pursuant to this Section
 4.2. 


	
 

	
 


	
 

	
                    4.2.4.
 Assumption of Marketing Authorization. As of the Effective Date,
 Therabel shall assume and maintain Javelin’s ownership rights and obligations
 for the approved marketing authorization for the Licensed Product in the
 Territory. Javelin hereby represents and warrants that, to the best of its
 knowledge, as of the Execution Date of the Agreement, it has completed all
 necessary development activities for the Licensed Product in the Field in
 connection with obtaining Regulatory Approval in the Territory. 


	
 

	
 


	
 

	
                    4.2.5.
 Clinical Trial Data. Therabel shall, at its sole cost and expense,
 maintain a database for any clinical trial data resulting from any Phase IV
 clinical studies, the Regulatory Submission Activities and Development
 activities hereunder. 


	
 

	
 


	
 

	
          4.3. Adverse Events. By, or as soon as
 reasonably possible following, the Effective Date, the Parties will enter
 into a pharmacovigilence agreement, which upon such execution will be
 attached as an exhibit hereto and hereby incorporated into this Agreement by
 reference (the “Pharmacovigilence Agreement”). The Parties will comply
 with the provisions of such agreement, however in the event of a conflict
 between the Pharmacovigilence Agreement and this Agreement, this Agreement
 shall govern. Therabel will maintain and will be the recognized holder of a
 safety database for Adverse Event reports related to the Licensed Product
 received by either Party in the Territory. Therabel will respond to any and
 all safety inquiries regarding the Licensed Product in the Territory. Each
 Party shall bear its own costs and expenses incurred in performing their
 obligations under the Pharmacovigilence Agreement and maintaining the Adverse
 Event database. For the avoidance of doubt, Javelin will maintain the safety
 database outside the Territory. 


	
 

	
 


	
 

	
          4.4. Product Label Changes. The Parties
 will present proposed product labeling changes for the Licensed Product to
 the JSC for approval and the Parties shall use Commercially Reasonable
 Efforts to agree on such changes; provided however that 





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
product
 label changes dictated by a Regulatory Authority will not require approval by
 the JSC. 


	
 

	
 


	
 

	
          4.5. Manufacture and Supply of Licensed Products.
 Javelin shall use Commercially Reasonable Efforts to cause that all of
 Javelin’s rights and obligations under all existing manufacturing and supply
 agreements for the Licensed Product as listed on Schedule 4.5(A) (the
 “Assumed Agreements”) be transferred to Therabel (or any Affiliated
 Company) and Therabel or such Affiliate shall assume said rights and
 obligations. Javelin represents and warrants that there are no outstanding
 obligations (including payment obligations) incumbent on Javelin under the
 Assumed Agreements, except as set forth in Schedule 4.5(B), and that
 there are no outstanding disputes or claims. Javelin shall provide support to
 Therabel for a period of [***] or until the Manufacturing of the Licensed
 Product is transitioned to Baxter Healthcare Corporation (“Baxter”),
 whichever is later, to facilitate the transfer of such rights and
 obligations. As of the Effective Date, Therabel shall be responsible for the
 Manufacture and supply of the Licensed Product and all costs associated
 thereto for Regulatory Submission and Commercialization of the Licensed
 Product in the Field in the Territory. Within [***] days of the Effective
 Date or as agreed by the Parties, Therabel shall pay Javelin for all the
 Existing Inventory that is currently located at [***], as set forth in Schedule
 4.5(C). The Existing Inventory that is not yet at [***] on the Effective
 Date shall be delivered by Javelin to Therabel, which delivery shall be made
 DDP at [***] and, subject to the last sentence of this Section 4.5, payment
 shall be made by Therabel promptly upon delivery. Notwithstanding the
 foregoing, (i) Javelin shall ensure that the Existing Inventory purchased by
 Therabel pursuant to this Section 4.5 shall be supplied as fully packaged
 finished goods which are ready for sale in the Territory and shall have been
 released by [***], and (ii) Therabel shall have no obligation to pay for the
 Existing Inventory manufactured by [***] until [***] has been approved as a
 manufacturer of the Licensed Product in the United Kingdom and such Existing
 Inventory has been delivered to [***] in a ready for sale form with not less
 than [***] shelf life from the time of delivery. 


	
 

	
 


	
 

	
          4.6. Quality Agreement. By, or as soon as
 reasonably possible following, the Effective Date, the Parties will enter
 into a quality agreement, which upon such execution will be attached as an
 exhibit hereto and hereby incorporated into this Agreement by reference (the
 “Quality Agreement”). The Quality Agreement will govern the procedure
 for dealing with product complaints related to the Existing Inventory and
 will be in force until such time as Therabel is supplied Licensed Product
 directly from their manufacturer. The Parties will comply with the provisions
 of such agreement, however in the event of a conflict between the Quality
 Agreement and this Agreement, this Agreement shall govern. 


	
 

	
 


	
 

	
          4.7. Commercialization in the Territory.
 Therabel shall Commercialize the Licensed Product in accordance with the
 Commercialization Plan as follows: 





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BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 


	
 

	
                    4.7.1.
 Commercialization Plan. Therabel shall submit to the JSC for its
 approval a strategic commercialization plan for the Licensed Product in the
 Territory (the “Commercialization Plan”) which sets forth,
 without limitation, (a) [***] marketing strategy that includes plans for market
 research, health economics, pricing and reimbursement, medical affairs and
 value added initiatives, (b) [***] communications strategy that includes
 plans for public relations, conferences and exhibitions and other external
 meetings, internal meetings and communications, publications and symposia,
 internet activities and core brand package (if relevant), (c) [***] strategy
 for Phase IV studies and lifecycle management activities, (d) a high level
 operating plan for the implementation of such strategies on an annual basis,
 including without limitation, information related to product positioning,
 core messages to be communicated, share of voice requirements and pricing
 strategies, (e) [***], (f) [***] and (g) [***]. The Commercialization Plan will
 be updated at least [***]. The Commercialization Plan shall reflect that the
 Commercialization of Licensed Product in [***] is a priority for Therabel and
 Therabel shall devote at least a similar degree of sales force incentives in
 support of said Commercialization as is the case for other traditional key products
 of Therabel’s current product portfolio that are comparable to the Licensed
 Product. 


	
 

	
 

	
 


	
 

	
                    4.7.2.
 Commercialization Activities. Within [***] of receipt of Regulatory
 Approval for the Licensed Product in any country in the Territory, Therabel
 shall use Commercially Reasonable Efforts to launch the Licensed Product in
 such country. Notwithstanding the foregoing, Therabel shall be excused from
 its obligation to launch the Licensed Product in a country in the Territory
 if. 


	
 

	
 

	
 


	
 

	
 

	
          (a)
 the combined royalties payable to Javelin and COGS (as set forth in Section
 5.3) are expected to exceed [***] percent ([***]%) of Net Sales, with such
 amount to be certified by the JSC; 


	
 

	
 

	
 


	
 

	
 

	
          (b)
 the requirement to carry out additional clinical studies in order to obtain
 reimbursement or a commercially reasonable price is judged by the JSC to be
 commercially unreasonable; or 


	
 

	
 

	
 


	
 

	
 

	
          (c)
 the JSC determines that the expected Net Sales Price or the expected
 reimbursed pricing for a Licensed Product in a country in the Territory will
 be greater than [***]% below the average Net Sales Price or the average
 reimbursed pricing (as applicable) achieved in countries where the Licensed
 Product is already launched. 


	
 

	
 

	
 


	
 

	
provided,
 however, if the JSC is unable to agree on such
 criteria listed above for excusing Therabel’s obligation to launch the
 Licensed Product in a country in the Territory, the





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
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matter shall
 be referred to the Dispute Resolution Panel, the costs of which shall be
 borne equally by the Parties. 


	
 

	
 


	
 

	
          Following
 the launch of the Licensed Product in a country in the Territory, Therabel
 will use Commercially Reasonable Efforts to Commercialize the Licensed
 Product in such country, in accordance with the Commercialization Plan. In
 conducting the Commercialization activities, Therabel will comply with all
 Applicable Laws and applicable industry professional standards. Therabel
 shall not make any claims or statements with respect to the Licensed Product
 that are not strictly consistent with the Licensed Product labeling and the
 sales and marketing materials approved for use pursuant to the
 Commercialization Plan. Therabel will book all sales of the Licensed Product
 and will have the sole responsibility for the sale, invoicing and
 distribution of the Licensed Product in the Territory, but without prejudice
 to Therabel’s right to have such activities subcontracted to Third Parties. 


	
 

	
 


	
 

	
          4.8. Phase IV and Publication Strategy.
 Subject to the approval of the JSC and Javelin, Therabel may undertake, or
 permit its Affiliates, licensees or Sublicensees to undertake within the
 Territory, any pre-clinical or clinical marketing studies of the Licensed
 Product in the Territory, including, without limitation, Phase IV studies and
 any post-approval studies required for registration or imposed by a
 Regulatory Authority in a country within the Territory. The cost of any
 pre-clinical or clinical marketing studies of the Licensed Product,
 including, without limitation, Phase IV studies and any post-approval studies
 required for registration or imposed by a Regulatory Authority in a country
 within the Territory, incurred after the Effective Date of the Agreement
 shall be the responsibility of Therabel. 


	
 

	
 


	
 

	
          The
 Parties will also coordinate worldwide publication strategy involving the
 Licensed Product and activities involving the Licensed Product related to
 scientific conferences inside and outside the Territory, including through
 delegation to appropriate working groups of the Parties. Each Party shall be
 afforded the opportunity to review and approve any scientific paper or presentation
 with respect to the Licensed Product proposed for publication, presentation
 or distribution by the other Party or its Affiliates and licensees or
 Sublicensees and shall have no more than [***] days to complete such review
 and approval or such shorter period as may reasonably be required by
 applicable publication deadlines promptly communicated to such Party. The
 Party proposing publication or presentation shall not unreasonably reject
 comments furnished by the other Party, will comply with the other Party’s
 request to delete references to its Confidential Information in any such
 publication or presentation and will delay publication for such reasonable
 period requested by the other Party to permit the filing of patent
 applications concerning any Therabel Technology or Javelin Technology
 disclosed in material proposed for such publication or presentation. In no
 event will Confidential Information of a Party be published without the
 consent of such Party. 





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The Parties
 will coordinate the disclosure of the initiation and results of clinical
 studies performed pursuant to the Regulatory Submission Plans or Development
 Plans or clinical studies performed by either Party’s licensees or
 Sublicensees with respect to the Licensed Product, whether within or outside
 of the Territory, to the extent required by law or best industry practices;
 provided that all proposed disclosures and publications will be submitted for
 expeditious review by the JSC and due regard will be given to the comments of
 each Party, the maintenance of confidentiality of Confidential Information of
 each Party and allowing time for intellectual property registrations. Nothing
 set forth herein shall be deemed to limit or restrict either Party from
 disclosing the results of clinical trials (whether performed by the Parties
 or by Third Parties) to the extent required by law or best industry
 practices. The Parties intend that the provisions of this Section 4.8 shall
 apply to the Parties and their respective Affiliates, licensees and
 Sublicensees. 


	
 

	
 


	
 

	
          4.9.
 Development. Subject to the JSC first agreeing on a
 Regulatory Submission Plan and a Commercialization Plan with respect to the
 relevant new forms of Licensed Product in accordance with Sections 4.1 and
 4.7 above, Therabel shall use Commercially Reasonable Efforts to Develop,
 seek Regulatory Approval for, and pursue the Commercialization of any new
 forms of Licensed Product, including without limitation a low-dose
 formulation, deemed by the JSC as having the opportunity to enhance the value
 of the Licensed Product. In the event the JSC is unable to agree on whether
 any such new form has the opportunity to enhance the value of the Licensed
 Product or whether such pursuit is Commercially Reasonable, the matter shall
 be referred to the Dispute Resolution Panel, the costs of which shall be
 borne equally by the Parties. To facilitate the Development, Therabel, with
 assistance from Javelin, shall prepare and submit to the JSC for its approval
 a Development Plan for such new forms of Licensed Product. As from its
 approval by the JSC, Therabel shall use Commercially Reasonable Efforts to
 implement the approved Development Plan. 


	
 

	
 


	
5.

	
CONSIDERATION. 


	
 

	
 


	
 

	
          5.1.
 Upfront Payments. Therabel shall mare a payment of
 Seven Million Dollars ($7,000,000) to Javelin within [***] days of the
 Effective Date, as an upfront, non-creditable, non-refundable fee. 


	
 

	
 


	
 

	
          5.2.
 Milestones. 


	
 

	
 


	
 

	
                    5.2.1.
 [***] Milestones. As additional consideration for the rights granted to
 Therabel pursuant to Section 2.1 and subject to Section 4.5.2, Therabel will
 pay Javelin the following one-time, non-refundable amounts after the
 occurrence of each of the following events: 





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EVENT
 (each a “[***] Milestone”)

	
 

	
MILESTONE
 PAYMENT


	
 

	


	
 

	



	
 

	
[***]

	
 

	
[***]


	
 


	
 

	
[***]

	
 

	
[***](1)


	
 


	
 

	
[***]

	
 

	
[***](2)


	
 


	
 

	
[***]

	
 

	
[***](3)








	
 

	
 

	
 


	
 

	
(1)

	
[***].


	
 

	
 

	
 


	
 

	
(2)

	
[***].


	
 

	
 

	
 


	
 

	
(3)

	
[***]. 


	
 

	
 

	
 


	
 

	
Each [***]
 Milestone shall be payable within [***] days of achievement of the event and
 shall be fully creditable within the country for which the [***] Milestone is
 associated against royalties on Net Sales of the Licensed Product payable to
 Javelin pursuant to Section 5.3 for (i) [***] from the date of removal of the
 Contraindication in the UK in the case of the [***] Milestone first listed
 above, (ii) [***] from [***] in the case of [***], and (iii) [***] from [***]
 in the other countries for which a [***] Milestone is due. For the avoidance
 of doubt, during the [***] or [***] term referred to in this Section above,
 no royalties on Net Sales of the Licensed Product pursuant to Section 5.3
 shall be due to Javelin, unless the royalties that would otherwise be due
 during said [***] or [***] term would be in excess of the corresponding
 milestone payment, in which case only the amount in excess of the milestone
 will be payable to Javelin. 


	
 

	
 


	
 

	
Notwithstanding
 the foregoing, in the event Therabel’s obligation to launch the Licensed
 Product in a country is excused pursuant to Section 4.5.2 and Therabel elects
 not to launch the Licensed Product, Therabel’s obligation to pay a [***]
 Milestone associated with such country shall also be excused. 


	
 

	
 


	
 

	
                    5.2.2.
 Sales Milestones. Therabel shall make the following one-time
 non-creditable and non-refundable payments to Javelin within [***] days after
 the first occurrence of each of the following events: 








	
 

	
 

	
 

	
 


	
 

	
EVENT

	
 

	
MILESTONE
 PAYMENT


	
 

	


	
 

	



	
 

	
[***]

	
 

	
[***]


	
 


	
 

	
[***]

	
 

	
[***]





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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
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EVENT

	
 

	
MILESTONE PAYMENT


	
 

	


	
 

	



	
 

	
[***]

	
 

	
[***]


	
 


	
 

	
[***]

	
 

	
[***]


	
 


	
 

	
[***]

	
 

	
[***]








	
 

	
 


	
 

	
For the
 avoidance of any doubt, the above-mentioned table cannot be construed as
 implying any warranty or commitment by Therabel that the annual Net Sales
 figures indicated therein will be achieved at any time. 


	
 

	
 


	
 

	
For the
 avoidance of doubt, if more than one of the milestones described above are
 achieved for any Calendar Year, all applicable milestone payments described
 above shall be made in such case. 


	
 

	
 


	
 

	
          5.3.
 Royalties. 


	
 

	
 


	
 

	
                    5.3.1.
 Payment of Royalties. Without prejudice to Section 5.3.2, Therabel
 shall pay to Javelin royalties based on the aggregate Net Sales of the
 Licensed Product sold by Therabel, its Affiliates or its Sublicensees in all
 countries in the Territory at a rate of [***] ([***]%) of such Net Sales. Notwithstanding
 the foregoing, if COGS for Licensed Products related to Net Sales in a
 particular country is greater than or equal to [***] (***]%) of Net Sales as
 determined on a country-by-country basis, then the royalty payable to Javelin
 under this Section in each such country shall be reduced by [***] ([***]%)
 for each percent that such COGS exceeds [***] ([***]%); provided, however,
 that in no case shall the royalties payable to Javelin pursuant to Section
 5.3 be less than [***] ([***]%) of Net Sales in any country- Therabel shall
 use Commercially Reasonable Efforts to reduce COGS related to Licensed
 Products. In connection therewith, Therabel shall verify to what extent it is
 feasible and more cost-efficient for it to complete the final European Union
 quality release for the Licensed Product within its internal Quality group
 (instead of such service being provided by Almac Pharma Services Limited as
 such is currently the case). In the event that Therabel’s cost to perform the
 final European Union quality release of the Licensed Product is lower than
 Almac Pharma Services Limited’s cost for such services but Therabel elects to
 continue to have such services performed by Almac, or other external
 provider, the difference in the cost shall be removed from the COGS
 definition and shall not be included in the royalty calculation under this
 Section 5.3.1. If the Parties are unable to agree on such difference in cost,
 the matter shall be referred to the Independent Financial Expert, the costs
 of which shall be borne equally by the Parties. 





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                    5.3.2.
 No Royalties – Reduced Royalties. Therabel shall have no obligation to
 pay the royalties due under this Section 5.3 on the Net Sales of the Licensed
 Product generated from sales of any Existing Inventory produced by Precision
 and delivered by Javelin pursuant to Section 4.4 hereof. In the event that a
 Third Party launches an intravenous and intramuscular bolus injection of
 diclofenac, the marketing authorization of which references the Licensed
 Product, and the Net Sales of the Licensed Product for any [***] decrease by
 more than [***] ([***]%) as compared to Net Sales of the Licensed Product for
 the [***] immediately preceding the launch of such Third Party product, then
 the royalties applicable in those countries of the Territory where such
 Product receives a marketing authorization shall be reduced to [***] ([***]%)
 of the Net Sales of the Licensed Product realized as from the date of said
 marketing authorization. 


	
 

	
 


	
 

	
                    5.3.3.
 Royalty Reports. Within [***] days after the beginning of each [***]
 beginning with the [***] in which the First Commercial Sale is made in the
 Territory, Therabel shall deliver to Javelin a report setting forth for the
 previous [***] the following information on a country-by-country basis: (a)
 the gross sales and Net Sales of the Licensed Product in the Territory, (b)
 the number of units sold by Therabel, its Affiliates or Sublicensees (if
 any), (c) the applicable COGS if the royalty rate has been reduced pursuant to
 Section 5.3.1, (d) the deductions taken in calculating Net Sales, including
 without limitation, discounts, allowances, rebates, and fees, (e) the royalty
 due hereunder for the sales of the Licensed Product, and (f) the applicable
 exchange rate as determined in accordance with this Agreement, all in
 sufficient detail to enable Javelin to determine the amounts due under this
 Agreement. Each such report shall also indicate the amount of Sublicense
 Income received by Therabel and the portion owed to Javelin for the preceding
 [***] pursuant to Section 5.3.5 (if any). The total royalty due for the sale
 of Licensed Products during such [***] and payments with respect to
 Sublicense Income shall be remitted within [***] days of receipt of an
 invoice from Javelin for the reported amounts. 


	
 

	
 


	
 

	
                    5.3.4.
 Royalty Terms. Subject to Sections 5.2.1 and 5.3.2, Therabel’s
 obligation to pay royalties to Javelin pursuant to this Section 5.3 shall
 commence on [***] and shall expire, on a country-by-country basis, on the
 later to occur of (a) expiration of data exclusivity related to the Licensed
 Product in such country, (b) the expiration date in such country of the last
 to expire of any such issued Javelin Patent Rights that includes at least one
 Valid Claim covering the sale of such Licensed Product in such country, or
 (c) the launch by a Third Party of an intravenous or intramuscular bolus
 injection of diclofenac in such country, the marketing authorization of which
 references the Licensed Product. In any non-European Union country of the
 Territory, which recognizes a marketing authorization of another country
 within the Territory and for which there is no Valid Claim covering the sale
 of the Licensed Product, the term for which Therabel owes royalties to Javelin
 in such country shall be the same as the country whose marketing
 authorization such country has recognized, provided no other intravenous or
 intramuscular bolus injection of diclofenac, the marketing authorization of 





26






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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
which
 references the Licensed Product, is on the market in that non-European Union
 country. Section 5.3.2 shall apply if such other intravenous or intramuscular
 bolus injection of diclofenac is on the market in that non-European Union
 country. For the avoidance of any doubt, this Agreement shall remain in force
 after the expiration of the Royalty Term, subject to Section 9 below. 


	
 

	
 


	
 

	
                    5.3.5.
 Sublicense Income. Therabel shall pay to Javelin [***] percent
 ([***]%) of all Sublicense Income. 


	
 

	
 


	
 

	
                    5.3.6.
 Third Party Obligations. Javelin shall be responsible for any and all
 royalty obligations to Third Parties (including to the IP Owners) existing as
 of the Effective Date related to the Licensed Product in the Territory. 


	
 

	
 


	
 

	
          5.4.
 Matters Concerning Payments. 


	
 

	
 


	
 

	
                    5.4.1.
 Records and Audits. During the Term of this Agreement, Therabel shall
 keep and maintain accurate and complete records showing all information set
 forth in royalty reports required hereunder and all Sublicense Income during
 the [***] preceding [***], which books and records shall be in sufficient
 detail such that Net Sales and royalties can accurately be determined. Upon
 [***] prior written notice from Javelin, Therabel shall permit an independent
 certified public accounting firm, selected by Javelin and reasonably
 acceptable to Therabel, to examine the relevant books and records of Therabel
 and its Affiliates as may be reasonably necessary to verify the reports
 submitted by Therabel in accordance with Section 5.3.3. An examination by
 Javelin under this Section 5.4.1 shall occur not more than once in any [***]
 and shall be limited to the pertinent books and records for any Calendar Year
 ending not more than [***] months before the date of the request. The accounting
 firm shall be provided access to such books and records at Therabel’s
 facility(ies) where such books and records are normally kept and such
 examination shall be conducted during Therabel’s normal business hours.
 Therabel may require the accounting firm to sign a standard non-disclosure
 agreement before providing the accounting firm access to Therabel’s
 facilities or records. Upon completion of the audit, the accounting firm
 shall provide both Javelin and Therabel a written report disclosing whether
 the reports submitted by Therabel are correct or incorrect and the specific
 details concerning any discrepancies. No other information shall be provided
 to Javelin. Additionally, Javelin shall be responsible for all costs and
 expenses incurred in conducting the audit; provided, however, that if
 the accounting firm determines that the reports submitted by Therabel are
 misstated by more than [***] ([***}%) to Javelin’s detriment, Therabel shall
 be responsible for all such costs and expenses. 


	
 

	
 


	
 

	
                    5.4.2.
 Taxes and Withholding. All payments under this Agreement shall be made
 without any deduction or withholding for or on account of any tax unless such
 deduction or withholding is required by Applicable Laws or regulations. If
 Therabel is so 





27






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
required to
 deduct or withhold, Therabel shall (i) promptly notify Javelin of such
 requirement, (ii) pay to the relevant authorities the full amount required to
 be deducted or withheld promptly upon the earlier of determining that such
 deduction or withholding is required or receiving notice that such amount has
 been assessed against Javelin, and (iii) promptly forward to Javelin an
 official receipt (or certified copy) or other documentation reasonably
 acceptable to Javelin evidencing such payment to such authorities and
 cooperate in any other manner as reasonably necessary to assist Javelin in
 obtaining any refund it is entitled to in connection therewith (if any). 


	
 

	
 


	
 

	
                    5.4.3.
 Currency. All amounts payable shall be in United States dollars. As
 applicable, Net Sales and all expenses incurred by Therabel shall be
 translated into United States dollars using the rate of exchange printed in
 the Eastern Edition of The Wall Street Journal on the last day of the
 applicable period. If, due to restrictions or prohibitions imposed by
 national or international authority, payments cannot be made as provided in
 this Section 5, the Parties shall consult with a view to finding a prompt and
 acceptable solution. 


	
 

	
 


	
 

	
                    5.4.4.
 Confidentiality. All financial information of a Party which is subject
 to review under this Section 5.4 shall be deemed to be Confidential
 Information subject to the provisions of Section 6.1, and such Confidential
 Information shall not be disclosed to any Third Party or used for any purpose
 other than verifying payments to be made by one Party to the other hereunder,
 provided, however, that such Confidential Information may be disclosed to
 Third Parties only to the extent necessary to enforce a Party’s rights under
 this Agreement. 


	
 

	
 


	
 

	
          5.5.
 Interest. Any payment under this Section 5 that is
 more than [***] days past due shall be subject to interest at an annual
 percentage rate of [***] if Therabel does not make payment within [***] days
 of its receipt of notice that such amount is past due. Likewise, any
 overpayment that is not refunded within [***] days after the date such
 overpayment was made shall thereafter be subject to interest at an annual
 percentage rate of [***]. Notwithstanding the preceding, if a Party contests
 any amounts due hereunder in good faith and promptly notifies the other Party
 of such dispute, interest shall not accrue as to amounts being so contested
 until [***] days following the presentation of such notice to the other
 Party. 


	
 

	
 


	
6.

	
COVENANTS. 


	
 

	
 


	
 

	
          6.1.
 Third Party Consents. Javelin undertakes to obtain
 and submit to Therabel within [***] days following the execution hereof the
 written confirmation from each of the IP Owners, confirming that each (i) to
 the extent necessary, approves the license grant to Therabel hereunder and
 (ii) to the extent Therabel would not already have such right under the
 existing contractual documentation by which the IP Owners are bound, agrees
 to grant, with respect to the Territory, a direct license to Therabel to the 





28






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
relevant
 technology owned or licensed by each of them in relation to the Licensed
 Product, should the license granted by each such IP Owner (directly or
 indirectly) to Javelin in relation to the Licensed Product be terminated for
 reasons other than due to the actions of Therabel or any party acting on
 Therabel’s behalf hereunder, included but not limited actions that constitute
 a breach of this Agreement by Therabel. 


	
 

	
 


	
 

	
          6.2.
 Confidentiality. 


	
 

	
 


	
 

	
                    6.2.1.
 Confidential Information. Except to the extent expressly permitted by
 this Agreement and subject to the provisions of Sections 6.2.2 and 6.2.3, at
 all times during the Term and for [***] years following the expiration or
 termination hereof, the receiving party (a) shall keep confidential and shall
 not publish or otherwise disclose any Confidential Information furnished to
 it by the disclosing party, except to those of the receiving party’s
 employees, Affiliates, consultants, advisors or representatives who have a
 need to know such information (collectively, “Recipients”) to perform
 such Party’s obligations hereunder and (b) shall not use the Confidential
 Information of the disclosing party directly or indirectly for any purpose
 other than performing its obligations hereunder. The receiving party shall be
 liable for any breach by any of its Recipients of the restrictions set forth
 in this Agreement. 


	
 

	
 


	
 

	
                    6.2.2.
 Exceptions to Confidentiality. The receiving party’s obligations set
 forth in this Agreement shall not extend to any information of the disclosing
 party:








	
 

	
 


	
 

	
          (a)
 that is or hereafter becomes part of the public domain through no wrongful
 act, fault or negligence on the part of a receiving party or its Recipients; 


	
 

	
 


	
 

	
          (b)
 that is received from a Third Party without restriction and without breach of
 any agreement or fiduciary duty between such Third Party and the disclosing
 party; 


	
 

	
 


	
 

	
          (c)
 that the receiving party can demonstrate by competent evidence was already in
 its possession without any limitation or restriction on use or disclosure
 prior to its receipt from the disclosing party; 


	
 

	
 


	
 

	
          (d)
 that is generally made available to Third Parties by the disclosing party
 without any restriction imposed by the disclosing party on disclosure,
 whether such restriction is by contract, fiduciary duty or by operation of
 law; or 


	
 

	
 


	
 

	
          (e)
 that the receiving party can demonstrate by competent evidence was
 independently developed by the receiving party without any reference to
 Confidential Information. 








	
 

	
 


	
 

	
                    6.2.3.
 Authorized Disclosure. Each Party and its Recipients may disclose
 Confidential Information to the extent that such disclosure is made in
 response to a valid





29






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
order,
 governmental inquiry or request (each an “order”) of a court of competent
 jurisdiction or other agency, as applicable; provided, however, that
 the receiving party shall first have given notice to the disclosing party and
 given the disclosing party a reasonable opportunity to quash such order or to
 obtain a protective order requiring that the Confidential Information and/or
 documents that are the subject of such order be held in confidence by such
 court or agency or, if disclosed, be used only for the purposes for which the
 order was issued; and provided further that if a disclosure order is not
 quashed or a protective order is not obtained, the Confidential Information
 disclosed in response to such court or governmental order shall be limited to
 that information that is legally required to be disclosed in such response to
 such court or governmental order. 


	
 

	
 


	
 

	
                    6.2.4.
 Notification. The receiving party shall notify the disclosing party
 immediately, and cooperate with the disclosing party as the disclosing party
 may reasonably request, upon the receiving party’s discovery of any loss or
 compromise of the disclosing party’s Confidential Information. 


	
 

	
 


	
 

	
                    6.2.5.
 Destruction of Confidential Information. Upon the entire expiration or
 the entire earlier termination of this Agreement (i.e. as opposed to an
 expiration or termination on a country by country basis or with respect to a
 specific number of countries only), the receiving party shall (a) destroy all
 tangible embodiments of Confidential Information of the disclosing party,
 including any and all copies thereof, and those portions of any documents,
 memoranda, notes, studies and analyses prepared by the receiving party or its
 Recipients that contain, incorporate or are derived from such Confidential
 Information and provide written certification of such destruction to the
 disclosing party in a form reasonably acceptable to the disclosing party,
 provided that the receiving party shall have the right to retain one copy of
 any such tangible embodiments for archival purposes, provided such copy shall
 continue to be maintained on a confidential basis subject to the terms of
 this Agreement, and (b) immediately cease, and shall cause its Recipients to
 cease, use of such Confidential Information as well as any information or
 materials that contain, incorporate or are derived from such Confidential
 Information. 


	
 

	
 


	
 

	
                    6.2.6.
 Use of Name and Disclosure of Terms. Each Party shall keep the
 existence of, the terms of and the transactions covered by this Agreement
 confidential and shall not disclose such information to any other Entity
 through a press release or otherwise, or mention or otherwise use the name,
 insignia, symbol, trademark, trade name or logotype (with the exception,
 however, of the Trademarks and the Dyloject Trademark, which may be used in
 accordance with the terms of this Agreement) of the other Party or its
 Affiliates in any manner without the prior written consent of the other Party
 in each instance (which shall not be unreasonably withheld). The restrictions
 imposed by this Section shall not prohibit either Party from snaking any
 disclosure that is required by Applicable Law, rule or regulation or the
 requirements of a national securities exchange or another similar regulatory
 body including disclosing such information in any 





30






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
clinical
 trial database maintained by or on behalf of a Party. Further, the
 restrictions imposed on each Party under this Section 6.2.6 are not intended,
 and shall not be construed, to prohibit a Party from identifying the other
 Party in its internal business communications, provided that any Confidential
 Information in such communications remains subject to this Section 6.2.6. 


	
 

	
 


	
 

	
                    6.2.7.
 Remedies. The Parties acknowledge and agree that the restrictions set
 forth in Section 6.2 are reasonable and necessary to protect the legitimate
 interests of the Parties and that neither Party would have entered into this
 Agreement in the absence of such restrictions, and that any breach or
 threatened breach of any provision of Section 6.2 will result in irreparable
 injury to the other Party for which there will be no adequate remedy at law.
 In the event of a breach or threatened breach of any provision of Section 6.2
 by a Party, the other Party shall be authorized and entitled to obtain from
 any court of competent jurisdiction injunctive relief, whether preliminary or
 permanent, specific performance and an equitable accounting of all earnings,
 profits and other benefits arising from such breach, which rights shall be
 cumulative and in addition to any other rights or remedies to which such
 Party may be entitled in law or equity. The breaching-Party agrees to waive
 any requirement that the non-breaching Party (i) post a bond or other security
 as a condition for obtaining any such relief and (ii) show irreparable harm,
 balancing of harms, consideration of the public interest or inadequacy of
 monetary damages as a remedy. Nothing in this Section 6.2.7 is intended, or
 shall be construed, to limit the Parties’ rights to equitable relief or any
 other remedy for a breach of any provision of this Agreement. 


	
 

	
 


	
 

	
          6.3.
 Compliance with Law. Each Party hereby covenants and
 agrees to comply with all Applicable Laws applicable to its activities connected
 directly or indirectly with the Licensed Products. Without limiting the
 generality of the foregoing: 


	
 

	
 


	
 

	
                    6.3.1.
 Patient Information. Each Party agrees to abide by all laws, rules,
 regulations, and orders of all applicable supranational, national, federal,
 state, provincial, and local governmental entities concerning the
 confidentiality or protection of patient identifiable information and/or
 patients’ protected health information or any other applicable legislation
 (including data protection legislation), in the course of their performance
 under this Agreement. 


	
 

	
 


	
 

	
                    6.3.2.
 Export Controls. This Agreement is made subject to any restrictions
 concerning the export of products or technical information from the United
 States or other countries which may be imposed upon or related to Javelin or
 Therabel from time to time. Each Party agrees that it shall not export,
 directly or indirectly, any technical information acquired from the other
 Party pursuant to this Agreement or any Licensed Products using such
 technical information to a location or in a manner that at the time of export
 requires an export license or other governmental approval, without first 





31






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]


	
 

	
 


	
 

	
obtaining the written
 consent to do so from the appropriate agency or other governmental entity. 


	
 

	
 


	
 

	

                    6.3.3.
Debarment. Each Party agrees that it shall not use, in any capacity, in
connection with any of its obligations to be performed under this Agreement
any individual who has been debarred under the FD&C Act or the Generic
Drug Enforcement Act or any foreign counterpart.  


	
 

	
 


	
7.

	
REPRESENTATIONS
 AND WARRANTIES.


	
 

	
 


	
 

	
          7.1.
 Representations and Warranties of Each Party. As of the Execution Date, each of Therabel
 and Javelin hereby represents and warrants to the other Party hereto as
 follows:








	
 

	
 

	
 


	
 

	
 

	
          (a)
 it is a corporation or entity duly organized and validly existing under the
 laws of the jurisdiction of its incorporation or formation; 


	
 

	
 

	
 


	
 

	
 

	
          (b)
 the execution, delivery and performance of this Agreement by such Party has
 been duly authorized by all requisite corporate action and does not require
 any shareholder action or approval; 


	
 

	
 

	
 


	
 

	
 

	
          (c)
 it has the power and authority to execute and deliver this Agreement and to
 perform its obligations hereunder; 


	
 

	
 

	
 


	
 

	
 

	
          (d)
 the execution, delivery and performance by such Party of this Agreement and
 its compliance with the terms and provisions does not and shall not conflict
 with or result in a breach of any of the terms and provisions of or
 constitute a default under (i) a loan agreement, guaranty, financing
 agreement, agreement affecting a product or other agreement or instrument
 binding or affecting it or its property; (ii) the provisions of its charter
 or operative documents or bylaws; or (iii) any order, writ, injunction or
 decree of any court or governmental authority entered against it or by which
 any of its property is bound; 


	
 

	
 

	
 


	
 

	
 

	
          (e)
 it has the full right, power and authority to grant all of the right, title
 and interest in the licenses granted to the other Party under this Agreement;
 and 


	
 

	
 

	
 


	
 

	
 

	
          (f)
 it is in good standing in accordance with the laws of its home jurisdiction
 and it has not filed (or it is not subject to) any petition for bankruptcy or
 other insolvency proceedings. 





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]


	
 

	
 

	
 


	
 

	
          7.2.
 Additional Representations and Warranties of Javelin. Javelin hereby represents and warrants to
 Therabel that as of the Execution Date and, to the extent provided for
 hereunder, during the entire duration of this Agreement: 


	
 

	
 

	
 


	
 

	
 

	
          (a)
 Javelin has all rights in and to the Javelin Technology necessary to perform
 its obligations under this Agreement; 


	
 

	
 

	
 


	
 

	
 

	
          (b)
 The Javelin Technology includes all Patent Rights, Know-How, Improvements and
 other intellectual property rights that are necessary in order to import,
 manufacture, have manufactured, use, Commercialize and, to the extent
 applicable, Develop the Licensed Product, as such Licensed Product are
 currently being Commercialized in the United Kingdom; 


	
 

	
 

	
 


	
 

	
 

	
          (c)
 Javelin holds the exclusive rights to the Javelin Technology in respect of
 the Development, the importation, the Manufacturing, the use, the
 Commercialization and the distribution of the Licensed Product in the Field
 in the Territory, and Javelin shall use Commercially Reasonable Efforts to
 maintain during the Term such rights and shall refrain from taking any action
 that is reasonably likely to result in a termination of any license to
 Javelin of such rights; 


	
 

	
 

	
 


	
 

	
 

	
          (d)
 The licenses obtained by Javelin from the applicable IP Owners in respect of
 the Licensed Product are, and during the Royalty Term shall continue to be,
 valid and enforceable against Javelin and, to Javelin’s knowledge, against
 the applicable IP Owners, and no circumstance has occurred, and to the best
 of Javelin’s knowledge, no circumstance is likely to occur, that may result
 in said licenses being terminated, revoked or otherwise losing its effects; 


	
 

	
 

	
 


	
 

	
 

	
          (e)
Except as set forth in Schedule 7.2(e) to this Agreement, Javelin is not
subject to any agreement with a Third Party that includes a royalty or
similar payment obligation to, or other restriction or limitation in favor
of, such Third Party with respect to its rights to practice the Javelin
Technology;  


	
 

	
 

	
 


	
 

	
 

	
          (f)
 No Javelin Patent Rights are subject to, or were developed pursuant to any
 funding agreement with any government or government agency; 


	
 

	
 

	
 


	
 

	
 

	
          (g)
 Javelin is not in breach of any material provisions of any agreements with
 Third Party relating to the Javelin Technology; 


	
 

	
 

	
 


	
 

	
 

	
          (h)
 The manufacture, use, sale, offer for sale and import of the Licensed Product
 in the Field in the Territory does not infringe any Valid Claim of a Third
 Party or, to Javelin’s knowledge, any other Third Party right; 


	
 

	
 

	
 


	
 

	
 

	
          (i)
 Javelin has not received any written or oral claim of ownership, inventorship
 or patent or trademark infringement from any Third Party with





33






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]


	
 

	
 

	
 


	
 

	
 

	
respect to the Javelin
 Technology, and Javelin is not aware of any reasonable basis for any such
 claim; and


	
 

	
 

	
 


	
 

	
 

	
          (j)
 Javelin has made available to Therabel true and complete copies of all
 Assumed Agreements, including all amendments thereto. 








	
 

	
 


	
 

	
          7.3.
 Additional Representations and Warranties of Therabel. Therabel hereby represents and warrants to
 Javelin that, Therabel has no products currently under development or
 Commercialization that will compete with the Licensed Product and Therabel
 shall not develop, have developed, import, make, have made, use, offer to
 sell and/or sell any injectable non-steroidal anti-inflammatory drug for use
 in the Field for the treatment of any indication for which the Licensed Product
 is approved in the Territory, except pursuant to the Agreement. 


	
 

	
 


	
 

	
          7.4.
 No Inconsistent Agreements. Neither Party has in effect, and after the Execution Date neither
 Party shall enter into, any oral or written agreement or arrangement that would
 be inconsistent with its obligations under this Agreement or limit the
 ability of either Party, as the case may be, to grant or accept the license
 set forth in Section 2 of this Agreement. 


	
 

	
 


	
 

	
          7.5.
 Disclaimer. THE
 FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER WARRANTIES,
 EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
 NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED
 WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE ALL OF WHICH ARE HEREBY
 SPECIFICALLY EXCLUDED AND DISCLAIMED. EACH PARTY HEREBY DISCLAIMS ANY
 REPRESENTATION OR WARRANTY THAT THE MANUFACTURE OR COMMERCIALIZATION OF ANY
 LICENSED PRODUCT UNDER THIS AGREEMENT WILL BE SUCCESSFUL. 








	
 

	
 

	
 

	
 


	
8.

	
INTELLECTUAL
 PROPERTY.


	
 

	
 

	
 


	
 

	
 

	
8.1.
 Ownership.


	
 

	
 

	
 

	
 


	
 

	
                 8.1.1.
 Ownership of Technology. Determinations as to which Party has invented
 any Patent Right or Know-How shall be made in accordance with the standards
 of inventorship under U.S. patent law. Subject to the license grant under
 Section 2 of this Agreement, Javelin shall own all Javelin Technology and
 Therabel Technology. In the case of Therabel Technology, Therabel shall
 assign and cause its employees, consultants and agents to assign its rights,
 title and interest in and to all Therabel Technology to Javelin and, in
 connection therewith, shall, at its own expense, execute any documents and
 take any actions reasonably requested by Javelin to effect such assignment.





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]


	
 

	
 

	
 

	
 


	
 

	
                 8.1.2.
 Employee Assignment. To the extent permissible under Applicable Laws,
 each Party will cause each employee and contractor conducting work on such
 Party’s behalf under this Agreement that is of such a nature that such work
 may result in creation of any intellectual property rights to sign a contract
 that (i) compels prompt disclosure to the Party of all Javelin Technology or
 Therabel Technology, as applicable, conceived or reduced to practice by such
 employee or contractor during any performance under this Agreement, (ii)
 automatically assigns to the Party all right, title and interest in and to
 all such Technology and all Patent Rights disclosing or claiming such
 Technology, and (iii) obligates such persons to similar obligations of
 confidentiality as set forth in this Agreement. Each Party will require each
 employee and contractor conducting work on such Party’s behalf under this
 Agreement that is of such a nature that such work may result in creation of
 any intellectual property rights to maintain, records in sufficient detail
 and in a good scientific manner appropriate for patent purposes to properly
 reflect all work done. 


	
 

	
 

	
 

	
 


	
 

	
 

	
8.2.
 Prosecution and Maintenance of Patent Rights and other IP Rights. 


	
 

	
 


	
 

	
                 8.2.1.
 Patent Prosecution and Maintenance. [***] will be primarily
 responsible for the preparation, filing, prosecution and maintenance of the
 Javelin Patent Rights, the Javelin Technology, the Therabel Patent Rights (if
 any) and the Therabel Technology (if any) in the Territory. 


	
 

	
 


	
 

	
                 8.2.2.
 Reversion Rights. If [***] decides not to file, prosecute or maintain
 a Patent Right covering, as applicable, Javelin Technology or Therabel
 Technology, to the extent such Technology is necessary or useful to
 Manufacture, or Commercialize a Licensed Product or conduct Regulatory
 Submission Activities, with respect to Javelin Technology or Therabel
 Technology within the Territory, it shall give [***] reasonable notice to
 that effect sufficiently in advance of any deadline for any filing with
 respect to such Patent Right or such Javelin Technology or Therabel
 Technology to permit [***] to carry out such activity. After such notice,
 [***] may file, prosecute and maintain the Patent Right or the Javelin
 Technology or Therabel Technology, and perform such acts as may be reasonably
 necessary for Therabel to file, prosecute or maintain such Patent Right or
 such Javelin Technology or Therabel Technology, at its sole cost and expense.
 If [***] does so elect, then [***] shall provide such cooperation to [***],
 including the execution and filing of appropriate instruments, as may
 reasonably be requested to facilitate the transition of such patent
 activities, and shall assign all of its right, title and interest to such
 patent, other than its rights thereto provided by this-Agreement, to [***]. 


	
 

	
 


	
 

	
                 8.2.3.
 Costs and Expenses. Costs and expenses of filing, prosecuting,
 maintaining, and extending the Javelin Patent Rights and the Javelin
 Technology, in the Territory will be [***]. Costs and expenses of filing,
 prosecuting, maintaining, and 





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extending the Therabel
 Patent Rights (if any) and the Therabel Technology (if any) shall be at [***]
 expense.








	
 

	
 

	
 

	
 


	
 

	
 

	
8.3.
 Trademarks. 


	
 

	
 

	
 

	
 


	
 

	
                 8.3.1.
 Licensed Product Trademark. Javelin herewith grants to Therabel, for
 the entire Term, an irrevocable and royalty-free license to use the
 Trademarks for the purpose of Manufacturing, seeking Regulatory Approval for
 and/or Commercializing Licensed Products in accordance with the terms of this
 Agreement. All Licensed Products shall be sold in the Territory using the
 Dyloject Trademark. To the extent that the Dyloject Trademark is not a
 registered Trademark in a country in the Territory, and is not capable of
 being registered or used in such country under Applicable Law, Therabel may
 select a Trademark for the Licensed Product in such country. No such
 Trademark shall be used outside the Territory, unless otherwise agreed by the
 Parties in writing. Without prejudice to the last sentence below, Javelin
 shall own such Trademarks subject to the license granted to Therabel herein,
 and shall be responsible for the filing, prosecution and maintenance of such
 Trademarks in the applicable country or countries within the Territory. If
 Javelin decides not to file, prosecute or maintain a Trademark in a country
 of the Territory, it shall give Therabel reasonable notice to that effect
 sufficiently in advance of any deadline for any filing with respect to such
 Trademark in such country to permit Therabel to carry out such activity.
 After such notice, Therabel may file, prosecute and maintain such Trademark
 in such country. In the event Therabel elects to pursue such activities, (i)
 Therabel shall become the owner of the Trademarks with respect to the
 Territory and (ii) the expenses of the selection, filing, prosecution and
 maintenance of the Trademark shall be borne by Therabel. 


	
 

	
 

	
 

	
 


	
 

	
                 8.3.2.
 Trademark Use. The manner of use of the Trademarks shall be subject to
 periodic review by the JSC. Neither Party shall use the Trademarks in a way
 that is inconsistent with the usage instructions approved by the JSC or,
 except as otherwise provided herein, use the Trademarks in combination with
 its other trademarks in a manner which would create combination marks. The
 Parties shall utilize the Trademarks within the Territory only in accordance
 with this Agreement. 


	
 

	
 

	
 

	
 


	
 

	
                 8.3.3.
 Party Name on Licensed Product Promotional Material. Subject to
 Applicable Laws, all Licensed Product promotional material will include
 Javelin’s trade name, Trademark, and other logos requested by Javelin (the
 “Javelin House Marks”) in a manner approved by the JSC. To effectuate the
 purposes of this Agreement, Javelin hereby grants to Therabel a royalty free
 license (with right of sublicense to its Affiliates or as expressly provided
 in Section 2.2), to use and display the Trademarks and the Javelin House
 Marks in connection with the Commercialization of the Licensed Product in the
 Territory, and all in accordance with this Agreement. All goodwill arising
 from the use of such Trademarks and Javelin House Marks shall inure to the
 benefit of Javelin. 





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8.4.
 Enforcement of Technology Rights and Trademarks. 


	
 

	
 

	
 

	
 


	
 

	
                 8.4.1.
 Notice. If Javelin or Therabel becomes aware that any Javelin Technology
 or Therabel Technology or any of the Trademarks is infringed or
 misappropriated by a Third Party in the Territory in the Field or is subject
 to a declaratory judgment action arising from such infringement
 (collectively, an “Infringement”), Javelin or Therabel, as the case may be,
 shall promptly notify the other Party. 


	
 

	
 

	
 

	
 


	
 

	
                 8.4.2.
 Enforcement. Javelin shall have the first right (but not the
 obligation), to enforce such Technology or Trademark against such
 Infringement; provided, that (i) Therabel shall have the right to join such
 proceeding at any time at its own expense and shall do so at any time
 (subject to Section 8.4.3) if it is deemed to be a necessary Party by the
 tribunal in which the Infringement is being prosecuted and (ii) neither Party
 shall admit the invalidity or unenforceability of any Technology owned solely
 by or jointly with the other Party without the other Party’s prior written
 consent. In the event Javelin declines to prosecute the infringing technology
 or to defend such claim within [***] days (or such shorter period as may be
 required to comply with legal or regulatory deadlines which relate to such
 infringement) of becoming aware thereof, Therabel shall have the right to so
 enforce or defend. The Parties will collaborate in the choice of counsel with
 respect to such action and the comments of Therabel shall not be unreasonably
 rejected with respect to strategic decisions and their implementation with
 respect to such action. In furtherance of the foregoing, Javelin shall keep
 Therabel reasonably informed, in person or by telephone, regarding the status
 and costs of such action or proceeding prior to and during any such
 enforcement. Neither Party shall settle any such action without the written
 consent of the other Party, such consent not to be unreasonably withheld.
 Neither Party shall incur any liability to the other as a consequence of such
 litigation or any unfavorable decision resulting therefrom, including any
 decision holding any of the Javelin Technology or Therabel Technology
 invalid, not infringed, not misappropriated or unenforceable. 


	
 

	
 

	
 

	
 


	
 

	
                 8.4.3.
 Costs and Recoveries. The Parties agree that the costs of such
 prosecution or defense of validity, shall be at [***]. The Parties agree that
 if Therabel joins the enforcement proceedings pursuant to Section 8.4.2, the
 proceeds of any awards, judgments or settlements obtained in connection with
 an Infringement in the Territory shall first be used to reimburse each party
 for all out-of-pocket costs incurred by the Parties in such prosecution or
 defense and validity, and the remainder shall [***]. 


	
 

	
 

	
 

	
 


	
 

	
 

	
8.5.
 Third Party Claims. 


	
 

	
 

	
 

	
 


	
 

	
                 8.5.1.
 Third Party Claims - Course of Action. If the Commercialization,
 Manufacture or Development of a Licensed Product under this Agreement is
 alleged by a Third Party to infringe a Third Party’s patent right(s) or
 misappropriate a Third Party’s





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trade secret, the Party
 becoming aware of such allegation shall promptly notify the other Party
 thereof, in writing, reasonably detailing the claim. 


	
 

	
 

	
 

	
 


	
 

	

                    8.5.2.
Third Party Suit. Without prejudice to Section 7.2(h) above, if a Third Party
sues a Party (the “Sued Party”) alleging that the Sued Party’s or the Sued
Party’s Sublicensees’ Manufacture, Commercialization or Development of a
Licensed Product infringes or shall infringe said Third Party’s patent
right(s) or misappropriates said Third Party’s trade secret or infringes said
Third Party’s trademarks, then upon the Sued Party’s request and in
connection with the Sued Party’s defense of any such Third Party suit, the
other Party shall provide reasonable assistance to the Sued Party for such
defense and shall join such suit if deemed a necessary party. The Sued Party
shall keep the other Party, if such other Party has not joined in such suit,
reasonably informed on a [***] basis, in person or by telephone, prior to and
during the pendency of any such suit. The Sued Party shall not admit the
invalidity of any patent within the Javelin Patent Rights or the Therabel
Patent Rights, nor settle any such suit, without written consent of the other
Party, such consent not to be unreasonably withheld. Subject to the Parties’
respective indemnity obligations pursuant to Section 10.1 and 10.2, all litigation
expenses, including settlement costs, royalties paid in settlement of any
such suit, and the payment of any damages to the Third Party, will be (i)
paid by Javelin if it relates to a Third Party Suit that already existed at
the Execution Date and (ii) shared equally by the Parties if it relates to a
Third Party Suit that is introduced after the Execution Date.  


	
 

	
 

	
 

	
 


	
 

	
          8.6.
 Patent Marking.
 Each Party agrees to mark and have its Affiliates and all Sublicensees mark
 all Licensed Products (or their containers or labels) sold pursuant to this
 Agreement in accordance with the applicable statutes or regulations in the
 country or countries of manufacture and sale thereof. 


	
 

	
 

	
 

	
 


	
 

	
          8.7.
 No Implied Licenses.
 Except as expressly set forth in this Agreement, no right or license under
 any Javelin Technology or Therabel Technology is granted or shall be granted
 by implication as a result of the respective rights of the Parties under this
 Agreement. All such rights or licenses are or shall be granted only as
 expressly provided in this Agreement. 


	
 

	
 

	
 

	
 


	
 

	
          8.8.
 Privileged Communications. In furtherance of this
 Agreement, it is expected that Therabel and Javelin will, from time to time,
 disclose to one another privileged communications with counsel, including
 opinions, memoranda, letters and other written, electronic and verbal
 communications. Such disclosures are made with the understanding that they
 shall remain confidential, they will not be deemed to waive any applicable
 attorney-client privilege and that they are made in connection with the
 shared community of legal interests existing between Javelin and Therabel,
 including the community of legal interests in avoiding infringement of any
 valid, enforceable patents of Third Parties and maintaining the validity of
 Javelin Patent Rights and Therabel Patent Rights. 





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9.

	
TERM AND TERMINATION. 


	
 

	
 


	
 

	
          9.1. Term. The term of this Agreement
 shall commence on the Effective Date and, unless earlier terminated as
 provided in this Section 9 shall continue in full force and effect on a
 country-by-country basis as long as any Licensed Product is being Developed
 or Commercialized for use in the Field (the “Term”). The Agreement cannot be
 terminated unilaterally by either Party, unless in accordance with the
 provisions of this Agreement.


	
 

	
 


	
 

	
          9.2. Termination.


	
 

	
 


	
 

	
                    9.2.1.
 Termination for Material Breach. This Agreement may be terminated
 effective immediately on a country-by-country basis, or in its entirety, by
 written notice by either Party at any time during the Term if the other Party
 materially breaches this Agreement, which breach remains uncured for [***]
 days measured from the date written notice of such breach is received by the
 breaching Party, which notice shall specify the nature of the breach and
 demand its cure, provided, however, that if such breach is not capable
 of being cured within the stated period and the breaching Party uses
 Commercially Reasonable Efforts to cure such breach during such period and
 presents a mutually agreeable remediation plan for such breach, this
 Agreement shall not terminate and the cure period shall be extended for such
 period provided in the remediation plan as long as the breaching party
 continues to use Commercially Reasonable Efforts to pursue the cure as
 provided in such remediation plan. In the event a material breach affects
 only certain but not all countries in the Territory, the remedy of
 termination shall only be effective, on a country-by-country basis with
 respect to the countries as to which such material breach occurred.
 Notwithstanding anything to the contrary set forth herein but subject to the
 limitations set forth in Section 10.1, termination shall not be deemed to
 relieve a defaulting party from any liability arising from such default.


	
 

	
 


	
 

	
                    9.2.2.
 Termination for Failure of Effective Date. If the Effective Date of
 this Agreement has not occurred on or before the [***] day following the
 Execution Date, either Party may, at any time thereafter until the Effective
 Date, terminate this Agreement immediately upon notice to the other Party.
 Notwithstanding the foregoing, Javelin undertakes to formally request for the
 approvals as referred to in Section. 6.1 above at the latest within [***]
 days following the Execution Date.


	
 

	
 


	
 

	
                    9.2.3.
 Therabel Right of Termination. Prior to its expiration, this Agreement
 may be terminated in its entirety (or with respect to the European Union
 countries collectively or with respect to the non-European Union countries
 collectively) at any time by Therabel for [***] effective upon [***] prior
 written notice to Javelin. If Therabel terminates for a material safety
 issue, Therabel will provide all assistance reasonably requested by Javelin
 for at least [***] days after such termination to identify, further
 characterize and fully document such safety issue and, subject to the last
 sentence





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of this
 Section 9.2.3, provide such other assistance as might be reasonably useful or
 necessary for Javelin to continue with the development or commercialization
 of the Licensed Product, but shall not be required to undertake any studies
 or other Development not then provided by the Development Plans. In addition,
 Therabel shall not be required to undertake any Development, Manufacturing or
 Commercialization activities or any other activities, in each case which
 implicate a material safety issue during such [***] day period.


	
 

	
 


	
 

	
                    9.2.4.
 Violation of Law. This Agreement may be terminated by either Party on
 giving [***] days’ written notice to the other, which shall be effective on
 the expiration date of such [***] day period in the event that the other
 Party (the “Violating Party’) is convicted of a felony for violating, or a
 final, non-appealable order is issued by a court of competent jurisdiction
 finding that the Violating Party violated, any Applicable Laws, the Federal
 Foreign Corrupt Practices Act or any securities laws or regulations
 (collectively, the “Relevant Laws”), which are of such a nature that the
 Violating Party’s violation of such Relevant Laws would prevent or
 substantially diminish a Party from performing or having the ability to
 perform its obligation pursuant to this Agreement. Such notice of termination
 must be given within [***] days of the terminating Party becoming aware of
 the circumstances described in this Section 9.2.4.


	
 

	
 


	
 

	
                    9.2.5.
 Effects of Termination b Therabel without Cause orb Javelin with Cause.
 If this Agreement is terminated by Therabel pursuant to 9.2.3, or by Javelin
 pursuant to Sections 9.2.1, 9.2.4, 9.2.7 or 9.3:








	
 

	
 


	
 

	
          (a)
 All licenses granted by Javelin to Therabel hereunder shall automatically
 terminate; 


	
 

	
 


	
 

	
          (b)
 Therabel shall assign to Javelin all right, title and interest in and to: (i)
 all Regulatory Submissions and Regulatory Approvals pertaining to any Licensed
 Product Controlled by Therabel, (ii) all of Therabel’s interest in any
 Trademark (including, without limitation, the goodwill symbolized by such
 Trademark) used to brand the Licensed Product (iii) all of Therabel’s
 interest in any copyrights to the extent necessary or useful for
 Commercializing the Licensed Product and (iv) all agreements related to the
 Manufacture of Licensed Products; 


	
 

	
 


	
 

	
          (c)
 Therabel shall furnish Javelin with reasonable cooperation to assure a smooth
 transition of any clinical or other studies in progress related to a Licensed
 Product which Javelin determines to continue in compliance with Applicable
 Laws and ethical guidelines applicable to the transfer or termination of any
 such studies. In addition, Therabel will return to Javelin or destroy, at
 Javelin’s sole discretion, all Javelin Confidential Information. Except as
 provided by this Section as of the Effective Date of such termination,
 Therabel shall have no further obligation to Javelin; 





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BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          (d)
 For a period of up to [***]  following such termination, Therabel
 shall, at Javelin’s request, supply Licensed Product to Javelin for sale in
 the Territory at a transfer price equal to Therabel’s cost;


	
 

	
 


	
 

	
          (e)
 Until termination is effective, Therabel shall continue to perform its
 obligations under the Regulatory Submission Plans and Commercialization Plan
 then in effect and pay all costs allocated for it to pay in accordance with
 any budgets then in effect, except with respect to activities that Javelin elects
 to discontinue; and


	
 

	
 


	
 

	
          (f)
 Therabel shall be responsible for all costs incurred by Javelin related to
 the transfer of marketing authorizations for the Licensed Product to a Third
 Party.








	
 

	
 


	
 

	
Subsection
 (a) above will be effective upon any such termination, and subsections (b),
 (c) and (d) and above shall be effective upon termination, or if such
 termination is by Therabel pursuant to Section 9.2.3, upon the earlier of
 such termination or Javelin’s earlier election.


	
 

	
 


	
 

	
                    9.2.6.
 Effects of Termination by Therabel. Upon any termination of this
 Agreement by Therabel pursuant to Sections 9.2.1, 9.2.2, 9.2.4, 9.2.7 or 9.3,
 all licenses granted by either Party to the other shall terminate and neither
 Party shall have any further liability to the other except to the extent of
 provisions which survive the termination of this Agreement by their
 respective terms and obligations accrued but remaining outstanding as of the
 effectiveness of termination.


	
 

	
 


	
 

	
                    9.2.7.
 Bankruptcy. This Agreement may be terminated by written notice by
 either Party at any time during the Term of this Agreement if the other Party
 shall file in any court or Agency, pursuant to any statute or regulation of
 any state or country, a petition in bankruptcy or insolvency or for
 reorganization or for an arrangement or for the appointment of a receiver or
 trustee of that Party or of its assets, or if the other Party proposes a
 written agreement of composition or extension of its debts, or if the other
 Party shall be served with an involuntary petition against it, filed in any
 insolvency proceeding, and such petition shall not be dismissed within [***]
 days after the filing thereof, or if the other Party shall propose or be a
 Party to any dissolution or liquidation, or if the other Party shall make an
 assignment for the benefit of its creditors.


	
 

	
 


	
 

	
          9.3.
 Change of Control. Each Party shall notify the other
 Party in writing, referencing this Section of the Agreement, immediately upon
 any Change of Control, and shall provide such notice where possible at least
 [***] days prior to the Change of Control.





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          9.4. Survival of Certain Obligations.
 Expiration or termination of this Agreement shall not relieve the Parties of
 any obligation accruing before such expiration or termination. The provisions
 of this Agreement that must, by their nature, survive expiration or
 termination of this Agreement to give effect to their intent, shall so
 survive, including without limitation Section 2.3; Section 5.4.1; Section 6;
 Section 9 and Section 10. Any expiration or early termination of this
 Agreement shall be without prejudice to the rights of either Party against
 the other accrued or accruing under this Agreement before termination.


	
 

	
 


	
10.

	
LICENSED PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE.


	
 

	
 


	
 

	
          10.1.
 Indemnification by Javelin. Javelin and its
 Affiliates shall indemnify and hold Therabel harmless from and against all
 damages, losses, expenses, claims (including wrongful death), demands, suits,
 penalties, judgments or administrative and judicial orders and liabilities
 (including, but not limited to, reasonable counsel fees and expenses)
 incurred, assessed or sustained by Therabel, its Affiliates, or any of their
 officers, directors, or employees with respect to, involving, or arising out
 of (i) Javelin’s negligence or willful misconduct, (ii) Javelin’s breach of
 any representation, warranty, obligation or covenant of this Agreement, and
 (iii) Javelin’s defense of any claim of Third Party infringement as set forth
 in Section 8.4.2.


	
 

	
 


	
 

	
          10.2.
 Indemnification by Therabel. Therabel and its
 Affiliates shall indemnify and hold Javelin and its Affiliates harmless from
 and against all damages, losses, expenses, claims (including wrongful death
 and product liability), demands, suits, penalties, judgments or
 administrative and judicial orders and liabilities (including, but not
 limited to, reasonable counsel fees and expenses) incurred, assessed or
 sustained by Javelin, its Affiliates, or any of their officers, directors, or
 employees with respect to, involving, or arising out of (i) Therabel’s
 negligence or willful misconduct, (ii) Therabel’s breach of any
 representation, warranty, obligation or covenant of this Agreement, (iii)
 Therabel’s defense of any claim of Third Party infringement as set forth in
 Section 8.4.2, or (iv) the sale, packaging, labeling, handling, advertising,
 distribution, consumption or use of the Licensed Product; except to the
 extent such claim arises from an event for which Javelin has an obligation to
 indemnify Therabel under Section 10.1.


	
 

	
 


	
 

	
          10.3.
 Procedure. Each Party shall notify the other in the
 event it becomes aware of a claim for which indemnification may be sought
 hereunder. In case any proceeding (including any governmental investigation)
 shall be instituted involving any Party in respect of which indemnity may be
 sought pursuant to this Section 10, such Party (the “Indemnified Party”)
 shall promptly notify the other Party (the “Indemnifying Party”) in
 writing and the Indemnifying Party and Indemnified Party shall meet to
 discuss how to respond to any claims that are the subject matter of such
 proceeding. The Indemnifying Party, upon request of the Indemnified Party,
 shall retain counsel reasonably satisfactory to the Indemnified Party to
 represent the Indemnified Party and shall pay the fees and





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expenses of
 such counsel related to such proceeding. In any such proceeding, the
 Indemnified Party shall have the right to retain its own counsel, but the
 fees and expenses of such counsel shall be at the expense of the Indemnified
 Party unless (i) the Indemnifying Party and the Indemnified Party shall have
 mutually agreed to the retention of such counsel or (ii) the named parties to
 any such proceeding (including any impleaded parties) include both the
 Indemnifying Party and the Indemnified Party and representation of both
 Parties by the same counsel would be inappropriate due to actual or potential
 differing interests between them. All such fees and expenses incurred
 pursuant to Section 10.1 or 10.2 shall be reimbursed as they are incurred.
 The Indemnifying Party shall not be liable for any settlement of any
 proceeding unless effected with its written consent. The Indemnifying Party
 shall not, without the written consent of the Indemnified Party, effect any
 settlement of any pending or threatened proceeding in respect of which the
 Indemnified Party is, or arising out of the same set of facts could have
 been, a party and indemnity could have been sought hereunder by the
 Indemnified Party, unless such settlement includes an unconditional release
 of the Indemnified Party from all liability on claims to which the indemnity
 relates that are the subject matter of such proceeding.


	
 

	
 


	
 

	
          10.4. Insurance. Javelin further agrees
 to use its reasonable efforts to obtain and maintain Product Liability
 Insurance, with reputable and financially secure insurance carriers to cover
 its indemnification obligations under Sections 10.1 with limits of not less
 than [***] per occurrence and [***] in the aggregate until the Existing
 Inventory produced by Precision and supplied by Javelin to Therabel is fully
 depleted. Limits may be covered by a combination of primary and umbrella
 insurance policies.


	
 

	
 


	
 

	
Therabel
 further agrees to use its reasonable efforts to obtain and maintain, during
 the Term of this Agreement, Product Liability Insurance, with reputable and
 financially secure insurance carriers to cover its indemnification
 obligations under Sections 10.2 with limits of not less than [***] per
 occurrence and [***] in the aggregate from and after commercial launch.
 Limits may be covered by a combination of primary and umbrella insurance
 policies.


	
 

	
 


	
 

	
          10.5. Liability Limitations. WITHOUT
 PREJUDICE TO THE FOREGOING, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE
 OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR
 EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES
 RESULT FROM A PARTY’S WILLFUL MISCONDUCT OR ARISE FROM A PARTY’S INDEMNIFICATION
 OBLIGATIONS UNDER THIS SECTION 10.





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11.

	
MISCELLANEOUS.


	
 

	
 


	
 

	
          11.1.
 Governing Law and Arbitration. The interpretation
 and construction of this Agreement shall be governed by the laws of The State
 of New York, excluding any conflicts or choice of law rule or principle that
 might otherwise refer construction or interpretation of this Agreement to the
 substantive law of another jurisdiction. Any and all disputes arising out of
 or in connection with this Agreement, including but not limited to disputes
 regarding its validity, interpretation or termination, shall be resolved and
 settled through negotiation between the Parties. To that effect, either Party
 shall serve a written notice upon the other (a “Dispute Notice”)
 proposing that the Parties seek to resolve the dispute by negotiation. If a
 dispute is not resolved within [***] days of the receipt of the Dispute
 Notice, such dispute shall, at the request of either Party, be settled in
 accordance with the ICC rules of arbitration by three arbitrators appointed
 in accordance with those rules. The site of arbitration shall be Geneva,
 Switzerland. The arbitration shall be conducted in English.


	
 

	
 


	
 

	
          11.2.
 Force Majeure. No liability shall result from, and
 no right to terminate shall arise, in whole or in part, based upon any delay
 in performance or non-performance, in whole or in part, by either of the
 Parties to this Agreement to the extent that such delay or non-performance is
 caused by an event of Force Majeure. “Force Majeure” means an event
 that is beyond a non-performing Party’s reasonable control, including an act
 of God, act of the other Party, strike, lock-out or other industrial/labor
 dispute, war, not, civil commotion, terrorist act, malicious damage,
 epidemic, quarantine, fire, flood, storm, natural disaster or compliance with
 any law or governmental order, rule, regulation or direction, whether or not
 it is later held to be invalid or inapplicable. The Force Majeure Party shall
 within [***] days of the occurrence of the Force Majeure event, give written
 notice to the other Party stating the nature of the Force Majeure event, its
 anticipated duration and any action being taken to avoid or minimize its
 effect. Any suspension of performance shall be of no greater scope and of no
 longer duration than is reasonably required and the Force Majeure Party shall
 use reasonable effort to remedy its inability to perform; provided,
 however, if the suspension of performance continues or is anticipated to
 continue for [***] days after the date of the occurrence, the unaffected
 Party shall have the right but not the obligation to perform on behalf of the
 Force Majeure Party for a period of such Force Majeure and such additional
 period as may be reasonably required to assure a smooth and uninterrupted
 transition of such activities. If such failure to perform would constitute a
 material breach of this Agreement in the absence of such event of Force
 Majeure, and continues for [***] from the date of the occurrence and the
 Parties are not able to agree on appropriate amendments within such period,
 such other Party shall have the right, notwithstanding the first sentence of
 this Section 11.2, to terminate this Agreement immediately by written notice
 to the Force Majeure Party, in which case neither Party shall have any
 liability to the other except for those rights and liabilities that accrued
 prior to the date of termination and the consequences of termination pursuant
 to Sections 9.2.5 or 9.2.6, as applicable, as if such termination was a
 termination as to which such consequences applied.





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TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          11.3.
 Additional Approvals. Therabel and Javelin shall
 cooperate and use respectively all reasonable efforts to make all other
 registrations, filings and applications, to give all notices and to obtain as
 soon as practicable all governmental or other consents, transfers, approvals,
 orders, qualifications authorizations, permits and waivers, if any, and to do
 all other things necessary or desirable for the consummation of the
 transactions as contemplated hereby. Neither Party shall be required,
 however, to divest or out-license products or assets or materially change its
 business if doing so is a condition of obtaining any governmental approvals
 of the transactions contemplated by this Agreement.


	
 

	
 


	
 

	
          11.4. Waiver
 and Non-Exclusion of Remedies. A Party’s failure to
 enforce, at any time or for any period of time, any provision of this
 Agreement, or to exercise any right or remedy shall not constitute a waiver
 of that provision, right or remedy or prevent such Party from enforcing any
 or all provisions of this Agreement and exercising any rights or remedies. To
 be effective any waiver must be in writing. The rights and remedies provided
 herein are cumulative and do not exclude any other right or remedy provided by
 law or otherwise available except as expressly set forth herein.


	
 

	
 


	
 

	
          11.5.
 Notices.


	
 

	
 


	
 

	
                    11.5.1.
 Notice Requirements. Any notice, request, demand, waiver, consent,
 approval or other communication permitted or required under this Agreement
 shall be in writing, shall refer specifically to this Agreement and shall be
 deemed given only if delivered by hand or sent by facsimile transmission
 (with transmission confirmed) or by internationally recognized overnight
 delivery service that maintains records of delivery, addressed to the Parties
 at their respective addresses specified in Section 11.5.2 or to such other
 address as the Party to whom notice is to be given may have provided to the
 other Party in accordance with this Section 11.5.1. Such Notice shall be
 deemed to have been given as of the date delivered by hand or transmitted by
 facsimile (with transmission confirmed) or on the second Business Day (at the
 place of delivery) after deposit with an internationally recognized overnight
 delivery service. This Section is not intended to govern the day-to-day
 business communications necessary between the Parties in performing their
 obligations under the terms of this Agreement.





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 

	
 


	
11.5.2. 

	
 Address for
 Notice.


	
 

	
 

	
 


	
 

	
For:

	
Javelin
 Pharmaceuticals, Inc.


	
 

	
 

	
125
 Cambridge Park Drive


	
 

	
 

	
Cambridge,
 MA 02140


	
 

	
 

	
Fax:
 617-349-4505


	
 

	
 

	
Attn:
 General Counsel


	
 

	
 

	
 


	
 

	
With a copy
 to:


	
 

	
 

	
 


	
 

	
 

	
Javelin
 Pharmaceuticals, Inc.


	
 

	
 

	
125
 Cambridge Park Drive


	
 

	
 

	
Cambridge,
 MA 02140


	
 

	
 

	
Fax:
 617-349-4505


	
 

	
 

	
Attn: Office
 of Business Development


	
 

	
 

	
 


	
 

	
And a copy
 to:


	
 

	
 

	
 


	
 

	
 

	
Ropes &
 Gray LLP


	
 

	
 

	
One
 International Place


	
 

	
 

	
Boston, MA
 02110


	
 

	
 

	
Fax:
 617-951-7050


	
 

	
 

	
Attn: Marc
 Rubenstein


	
 

	
 

	
 


	
 

	
For:

	
Therabel
 Pharma NV.


	
 

	
 

	
Takkebijsters
 17


	
 

	
 

	
4817BL Breda


	
 

	
 

	
the
 Netherlands


	
 

	
 

	
Fax:


	
 

	
 

	
Attn:


	
 

	
 

	
 


	
 

	
With a copy
 to:


	
 

	
 

	
 


	
 

	
 

	
Dechert LLP


	
 

	
 

	
480 Avenue
 Louise, box 13


	
 

	
 

	
B-1050
 Brussels, Belgium


	
 

	
 

	
Fax : +32 2
 535 54 00


	
 

	
 

	
Attn:
 Fabrice Mourlon Beernaert





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          11.6. Entire Agreement. This Agreement
 constitutes the entire agreement between the Parties with respect to the
 subject matter of the Agreement. This Agreement supersedes all prior
 agreements, whether written or oral, with respect to the subject matter
 hereof Each Party confirms that it is not relying on any representations,
 warranties or covenants of the other Party except as specifically set out in
 this Agreement. Nothing in this Agreement is intended to limit or exclude any
 liability for fraud. All Schedules or Exhibits referred to in this Agreement
 are intended to be and are hereby specifically incorporated into and made a
 part of this Agreement. In the event of any inconsistency between any such
 Schedules or Exhibits and this Agreement, the terms of this Agreement shall
 govern. 


	
 

	
 


	
 

	
          11.7. Amendment. Any amendment or
 modification of this Agreement must be in writing and signed by authorized
 representatives of both Parties. 


	
 

	
 


	
 

	
          11.8. Assignment. Neither Party may
 assign its rights or delegate its obligations under this Agreement, in whole
 or in part without the prior written consent of the other Party, except that
 each Party shall always have the right, without such consent, (a) to perform
 any or all of its obligations and exercise any or all of its rights under this
 Agreement through any of its Affiliates, and (b) on written notice to the
 other Party, to assign any or all of its rights and delegate or subcontract
 any or all of its obligations hereunder (i) to any of its Affiliates, (ii) in
 connection with a Change of Control or (iii) to a successor to substantially
 all of the assets of the business related to the Licensed Product.
 Notwithstanding the foregoing, each Party shall remain responsible for any
 failure to perform on the part of any such Affiliates. Any attempted
 assignment or delegation in violation of this Section shall be void. 


	
 

	
 


	
 

	
          11.9.
No Benefit to Others. The
 provisions of this Agreement are for the sole benefit of the Parties and
 their successors and permitted assigns, and they shall not be construed as
 conferring any rights in any other persons except as otherwise expressly
 provided in this Agreement. 


	
 

	
 


	
 

	
          11.10. Counterparts. This Agreement may
 be executed in any number of counterparts, each of which shall be deemed an
 original and all of which taken together shall be deemed to constitute one
 and the same instrument. An executed signature page of this Agreement
 delivered by facsimile transmission shall be as effective as an original
 executed signature page. 


	
 

	
 


	
 

	
          11.11. Severability. To the fullest
 extent permitted by applicable law, the Parties waive any provision of law
 that would render any provision in this Agreement invalid, illegal or
 unenforceable in any respect. If any provision of this Agreement is held to
 be invalid, illegal or unenforceable, in any respect, then such provision
 will be given no effect by the Parties and shall not form part of this
 Agreement. To the fullest extent permitted by applicable law and if the
 rights or obligations of any Party will not be 





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
materially
 and adversely affected, all other provisions of this Agreement shall remain
 in full force and effect and the Parties will use their best efforts to
 negotiate a provision in replacement of the provision held invalid, illegal
 or unenforceable that is consistent with applicable law and achieves, as
 nearly as possible, the original intention of the Parties. 


	
 

	
 


	
 

	
          11.12. Further Assurance. Each Party
 shall perform all further acts and things and execute and deliver such
 further documents as may be necessary or as the other Party may reasonably
 require to implement or give effect to this Agreement. 


	
 

	
 


	
 

	
          11.13. Publicity. Notwithstanding Section
 6.2.6, it is understood that the Parties will issue a press release announcing
 the execution of this Agreement in such form as the Parties shall mutually
 agree. The Parties agree to consult with each other reasonably and in good
 faith with respect to the text and timing of any subsequent press releases
 relating to the Agreement or the activity hereunder prior to the issuance
 thereof, provided that a Party may not unreasonably withhold consent to such
 releases, and that either Party may issue such press releases as it
 determines, based on advice of counsel, are reasonably necessary to comply
 with laws or regulations or for appropriate market disclosure or which are
 consistent with information disclosed in prior releases properly made
 hereunder. 


	
 

	
 


	
 

	
          11.14. Relationship of the Parties. The
 status of a Party under this Agreement shall be that of an independent
 contractor. Nothing contained in this Agreement shall be construed as
 creating a partnership, joint venture, or agency relationship between the
 Parties or, except as otherwise expressly provided in this Agreement, as granting
 either Party the authority to bind or contract any obligation in the name of
 or on the account of the other Party or to make any statements,
 representations, warranties, or commitments on behalf of the other Party. All
 persons employed by a Party or any of its Affiliates shall be employees of
 such Party or its Affiliates and not of the other Party or such other Party’s
 Affiliates and all costs and obligations incurred by reason of any such
 employment shall be for the account and expense of such Party or its
 Affiliates, as applicable. 





[Remainder of Page Intentionally Left Blank]


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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


	
 

	
 


	
 

	
          IN
 WITNESS WHEREOF, duly authorized representatives of the Parties have duly
 executed this Agreement to be effective as of the Execution Date. 








	
 

	
 

	
 

	
 

	
 


	
THERABEL
 PHARMA NV

	
 

	
JAVELIN
 PHARMACEUTICALS, INC.


	
 

	
 

	
 

	
 

	
 


	
By:

	
/s/
 Jean-Michel Robert

	
 

	
By:

	
/s/ Martin
 J. Driscoll


	
 

	


	
 

	
 

	



	
 

	
 

	
 


	
Name:
 Jean-Michel Robert

	
 

	
Name: Martin
 J. Driscoll


	
 

	
 

	
 


	
Title:
 Director

	
 

	
Title: Chief
 Executive Officer





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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


SCHEDULE 1.42


Javelin Patent Rights


The following
are those patent applications and patents Controlled by Javelin, which Javelin,
as of the Effective Date, has identified as potentially being useful in
connection with the Licensed Product in the Field and Territory. 


	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 


	
Title

	
 

	
Status

	
 

	
Country

	
 

	
Application

 Number

	
 

	
Filing Date

	
 

	
Patent

 Number

	
 

	
Issue

 Date


	


	
 

	


	
 

	


	
 

	


	
 

	


	
 

	


	
 

	



	
[***]

	
 

	
[***]

	
 

	
[***]

	
 

	
[***]

	
 

	
[***]

	
 

	
[***]

	
 

	
[***]





1






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


SCHEDULE 1.71


Territory


[***]


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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


SCHEDULE 4.5(A)


Assumed Agreements


Development
and Toll Manufacturing Agreement between Javelin Pharmaceuticals, Inc. and
Baxter Healthcare Corporation dated as of July 30, 2008. 


Master
Services Agreement between Javelin Pharmaceuticals, Inc. and Innovex Europe
Limited dated as of July 30, 2007 and all project orders thereunder 


Services
Agreement between Javelin Pharmaceuticals, Inc. and Almac Pharma Services
Limited dated 2007 


Three-Way
Technical Agreement among Javelin Pharmaceuticals, Inc., Baxter Healthcare
Corporation and Almac Pharma Services, UK dated September 18, 2008 


SCHEDULE 4.5(B)


Pursuant to
the agreements with Baxter Healthcare Corporation and Almac Pharma Services
Limited, the Company has minimum purchase obligations and minimum service
obligations, respectively 


3






[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


SCHEDULE 4.4(C)


Quantities and Pricing for Existing Inventory


[***]


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[*CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 


SCHEDULE 7.2(e)


Javelin Agreements with Third Parties


License
Agreement among Farmarc N.A.N.V., Farmac Netherlands, B.V., Shimoda Biotech
(Proprietary) Ltd. and Innovated Drug Delivery Systems, Inc. dated as of
December 14, 2001 


5