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.

Right of First Offer to [***]

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

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

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

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

          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.

          1.4. “ 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

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.

          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 [***] months. The estimated quantities of such inventory are set forth in Schedule 4.5(C).

          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

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

          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;

          (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 §

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

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.

          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.

           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