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LICENSE AND COLLABORATION AGREEMENT dated as of December 4, 2007

Collaboration Agreement

LICENSE AND COLLABORATION AGREEMENT dated as of December 4, 2007 | Document Parties: ADOLOR CORP | ADOLOR CORPORATION | Pfizer Inc You are currently viewing:
This Collaboration Agreement involves

ADOLOR CORP | ADOLOR CORPORATION | Pfizer Inc

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Title: LICENSE AND COLLABORATION AGREEMENT dated as of December 4, 2007
Governing Law: Delaware     Date: 2/29/2008
Industry: Biotechnology and Drugs     Law Firm: Morgan Lewis     Sector: Healthcare

LICENSE AND COLLABORATION AGREEMENT dated as of December 4, 2007, Parties: adolor corp , adolor corporation , pfizer inc
50 of the Top 250 law firms use our Products every day

Exhibit 10.14

LICENSE AND COLLABORATION AGREEMENT

dated as of December 4, 2007

by and between

ADOLOR CORPORATION

and

PFIZER INC.

 


TABLE OF CONTENTS

 

          Page
ARTICLE 1   

DEFINITIONS

   2
ARTICLE 2   

LICENSE GRANTS; EXCLUSIVITY

   21

2.1

  

LICENSE GRANT TO PFIZER

   21

2.2

  

LICENSE GRANT TO ADOLOR

   21

2.3

  

RESEARCH LICENSE

   21

2.4

  

SUBLICENSING AND SUBCONTRACTING

   22

2.4.1

  

RIGHT TO SUBLICENSE

   22

2.4.2

  

RIGHT TO SUBCONTRACT

   23

2.4.3

  

LIABILITY FOR AFFILIATES, SUBLICENSEES AND SUBCONTRACTORS

   23

2.5

  

PATENT CHALLENGE

   23
ARTICLE 3   

EXCLUSIVITY; ACQUISITION OF UNNAMED COMPOUNDS; ADDITION AND REMOVAL OF NAMED COMPOUNDS AND NAMED INDICATIONS

   24

3.1

  

EXCLUSIVITY

   24

3.1.1

  

NON-COMPETE

   24

3.1.2

  

ACQUISITION OF A COMPETING PRODUCT

   24

3.2

  

ADDITIONAL NAMED COMPOUNDS

   26

3.2.1

  

**

   27

3.2.2

  

**

   27

3.2.3

  

**

   28

3.2.4

  

**

   29

3.2.5

  

COMMERCIALIZED ACQUIRED UNNAMED COMPOUND INCLUSION OPTION

   30

3.2.6

  

IN-LICENSE TRANSACTIONS

   32

3.2.7

  

ADDITIONAL OPTION PERIODS

   32

3.2.8

  

THIRD PARTY AGREEMENT FOR UNNAMED COMPOUNDS FOR OTHER THAN NAMED INDICATIONS

   32

3.2.9

  

FAILURE TO EXERCISE OPTION

   32

3.2.10

  

CONSEQUENCES OF EXERCISE OF NEW COLLABORATION COMPOUND OPTIONS

   33

3.3

  

ADDITIONAL INDICATIONS FOR NAMED COMPOUNDS; UNNAMED COMPOUNDS FOR NAMED INDICATIONS

   33

3.3.1

  

ADDITIONAL PROPOSAL

   33

3.3.2

  

ACCEPTANCE OF UNNAMED COMPOUND OR PROPOSED INDICATION

   33

3.3.3

  

REJECTION OF PROPOSED UNNAMED COMPOUND OR INDICATION

   33

 

i

 


TABLE OF CONTENTS

(continued)

 

          Page

3.4

  

REMOVAL OF NAMED COMPOUNDS AND NAMED INDICATIONS FROM THE COLLABORATION

   34

3.5

  

SCREENING OPTION

   34
ARTICLE 4   

GOVERNANCE OF DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS

   34

4.1

  

JOINT STEERING COMMITTEE

   34

4.1.1

  

MEMBERS; OFFICERS

   34

4.1.2

  

RESPONSIBILITIES

   34

4.1.3

  

MEETINGS

   35

4.1.4

  

DECISION-MAKING

   35

4.2

  

JOINT DEVELOPMENT COMMITTEE

   36

4.2.1

  

MEMBERS; OFFICERS

   36

4.2.2

  

RESPONSIBILITIES

   36

4.2.3

  

MEETINGS

   37

4.2.4

  

DECISION-MAKING

   38

4.3

  

U.S. COMMERCIALIZATION COMMITTEE

   38

4.3.1

  

USCC FORMATION

   38

4.3.2

  

MEMBERS; OFFICERS

   38

4.3.3

  

RESPONSIBILITIES OF USCC UNDER NET PROFIT/NET LOSS SHARING ARRANGEMENT

   38

4.3.4

  

FUNCTION OF THE USCC IN THE ABSENCE OF NET PROFIT/NET LOSS SHARING ARRANGEMENT

   39

4.3.5

  

MEETINGS

   39

4.3.6

  

DECISION-MAKING

   39

4.3.7

  

ROW COMMERCIALIZATION

   39

4.4

  

JOINT SUPPLY CHAIN COMMITTEE

   40

4.4.1

  

MEMBERS; OFFICERS

   40

4.4.2

  

RESPONSIBILITIES

   40

4.4.3

  

MEETINGS

   40

4.5

  

WITHDRAWAL FROM COMMITTEES

   40

4.6

  

ALLIANCE MANAGERS

   41

4.7

  

COLLABORATION PRINCIPLES

   41

4.8

  

EXCHANGE OF INFORMATION

   41

4.9

  

MINUTES OF COMMITTEE MEETINGS

   42

4.9.1

  

DISTRIBUTION OF MINUTES

   42

 

ii

 


TABLE OF CONTENTS

(continued)

 

          Page

4.9.2

  

REVIEW OF MINUTES

   42

4.9.3

  

DISCUSSION OF COMMENTS

   42

4.10

  

EXPENSES

   42
ARTICLE 5   

DEVELOPMENT OF PRODUCTS

   42

5.1

  

DEVELOPMENT

   42

5.2

  

DEVELOPMENT AND DISCONTINUATION OF DEVELOPMENT

   42

5.2.1

  

DEVELOPMENT OF LICENSED PRODUCTS

   42

5.2.2

  

DISCONTINUATION OF DEVELOPMENT

   43

5.3

  

DEVELOPMENT PLANS

   43

5.3.1

  

DEVELOPMENT PLAN FOR INITIAL NAMED COMPOUNDS

   43

5.3.2

  

DEVELOPMENT PLANS FOR NEW COLLABORATION COMPOUNDS OR ADDITIONAL INDICATIONS

   44

5.3.3

  

SCOPE OF DEVELOPMENT PLAN

   44

5.3.4

  

UPDATES TO THE DEVELOPMENT PLAN

   44

5.4

  

IMPLEMENTATION OF DEVELOPMENT PLAN

   44

5.5

  

DEVELOPMENT BUDGET AND FUNDING

   44

5.5.1

  

DEVELOPMENT BUDGETS

   44

5.5.2

  

COST SHARING OPT OUTS

   45

5.6

  

ACCESS TO RECORDS AND FACILITIES

   46
ARTICLE 6   

COMMERCIALIZATION AND CO-PROMOTE OPTION

   46

6.1

  

COMMERCIALIZATION

   46

6.2

  

COMMERCIALIZATION PLAN

   47

6.2.1

  

PREPARATION AND UPDATING OF COMMERCIALIZATION PLANS

   47

6.2.2

  

CONTENTS OF COMMERCIALIZATION PLAN

   47

6.2.3

  

BUDGET FOR COMMERCIALIZATION EXPENSES

   48

6.3

  

TRADEMARKS

   48

6.4

  

CO-PROMOTE OPTION

   48

6.5

  

COMMERCIALIZATION PLAN

   49

6.6

  

COOPERATION AND COORDINATION

   49

6.7

  

SALES REPRESENTATIVES; TRAINING

   49

6.8

  

USE OF PROMOTIONAL MATERIALS IN CO-PROMOTION

   51

6.9

  

SAMPLES

   51

6.10

  

CONTRACT SALES FORCES

   51

 

iii

 


TABLE OF CONTENTS

(continued)

 

          Page

6.11

  

COMPENSATION FOR ADOLOR’S CO-PROMOTION ACTIVITIES; DETAIL REPORTS

   51

6.11.1

  

COMPENSATION FOR DETAILING ACTIVITIES

   51

6.11.2

  

REPORTS

   51

6.11.3

  

RECORDS AND AUDITS PERTAINING TO DETAILS

   52

6.11.4

  

DETAIL SHORTFALLS

   52

6.12

  

CONDUCT OF COMMERCIALIZATION ACTIVITIES

   53

6.12.1

  

STATEMENTS ABOUT THE LICENSED PRODUCTS

   53

6.12.2

  

MAINTENANCE OF RECORDS

   53

6.12.3

  

COMPLIANCE WITH LAW

   53

6.12.4

  

MEDICAL AND SCIENTIFIC AFFAIRS

   54

6.13

  

TERMINATION OF CO-PROMOTE

   54

6.14

  

DISCONTINUATION OF COMMERCIALIZATION

   54
ARTICLE 7   

FINANCIAL PROVISIONS

   54

7.1

  

UPFRONT PAYMENT

   54

7.2

  

REIMBURSEMENT OF PRIOR DEVELOPMENT COSTS FOR PHASE 2A STUDIES

   54

7.3

  

MILESTONE PAYMENTS

   55

7.4

  

SALE OF LICENSED PRODUCTS IN THE UNITED STATES

   56

7.4.1

  

NET PROFIT/NET LOSS SHARING OF LICENSED PRODUCTS

   56

7.4.2

  

CONVERSION TO ROYALTY

   56

7.5

  

PAYMENT OF ROYALTIES ON NET SALES IN THE ROW

   57

7.6

  

ROYALTY TERM

   57

7.7

  

GENERIC COMPETITION; THIRD PARTY ROYALTY PAYMENTS

   58

7.7.1

  

GENERIC COMPETITION

   58

7.7.2

  

**

   58

7.7.3

  

THIRD PARTY ROYALTY

   58

7.7.4

  

MAXIMUM ROYALTY REDUCTION

   59

7.8

  

NOTICES OF TERMINATION

   59

7.9

  

REPORTS AND PAYMENTS

   59

7.9.1

  

INTERCOMPANY SALES

   59

7.9.2

  

ADOLOR REPORT

   59

7.9.3

  

PFIZER REPORT FOR NET PROFIT/NET LOSS SHARING

   60

7.9.4

  

FINAL PFIZER REPORT

   60

7.9.5

  

PFIZER PAYMENT/INVOICE FOR NET PROFIT/NET LOSS SHARING

   60

 

iv

 


TABLE OF CONTENTS

(continued)

 

          Page

7.9.6

  

PFIZER REPORT UNDER ROYALTY PAYMENT ARRANGEMENT

   60

7.9.7

  

ROYALTY PAYMENT

   61

7.9.8

  

DELIVERY OF REPORTS AND PAYMENTS

   61

7.10

  

GAAP

   61

7.11

  

CURRENCIES

   61

7.12

  

MANNER OF PAYMENTS

   61

7.13

  

INTEREST ON LATE PAYMENTS

   61

7.14

  

TAX WITHHOLDING; VALUE ADDED TAX

   62

7.14.1

  

WITHHOLDING

   62

7.14.2

  

VALUE-ADDED TAX

   62

7.15

  

FINANCIAL RECORDS; AUDITS

   63

7.16

  

RIGHT OF OFFSET

   63
ARTICLE 8   

REGULATORY MATTERS

   64

8.1

  

GENERAL

   64

8.2

  

TRANSFER OF INDS FOR THE INITIAL NAMED COMPOUNDS

   64

8.3

  

COMMUNICATIONS WITH REGULATORY AUTHORITIES

   64

8.4

  

DRUG SAFETY

   65

8.5

  

REGULATORY INFORMATION

   65

8.6

  

RECALLS OR OTHER CORRECTIVE ACTION

   65
ARTICLE 9   

MANUFACTURING AND DISTRIBUTION

   65

9.1

  

DISTRIBUTION

   65

9.2

  

MANUFACTURING TRANSFER

   65

9.3

  

SUPPLY OF NAMED COMPOUNDS AND LICENSED PRODUCTS

   66

9.4

  

MANUFACTURING COST IMPROVEMENT

   66

9.5

  

MANUFACTURING PARTICIPATION

   66
ARTICLE 10   

CONFIDENTIAL INFORMATION; PUBLICATIONS AND PUBLICITY

   67

10.1

  

CONFIDENTIAL INFORMATION

   67

10.2

  

PUBLICATIONS

   68

10.3

  

REGISTRATION AND FILING OF THIS AGREEMENT

   68

10.4

  

PUBLICITY

   69
ARTICLE 11   

REPRESENTATIONS AND WARRANTIES; COVENANTS

   69

11.1

  

MUTUAL REPRESENTATIONS AND WARRANTIES

   69

11.2

  

ADDITIONAL PFIZER REPRESENTATIONS AND WARRANTIES

   70

11.3

  

ADDITIONAL ADOLOR REPRESENTATIONS AND WARRANTIES

   71

11.4

  

COVENANTS

   72

 

v

 


TABLE OF CONTENTS

(continued)

 

          Page

11.5

  

ADDITIONAL COVENANTS OF ADOLOR

   73

11.6

  

DISCLAIMER OF WARRANTY

   73

ARTICLE 12

  

INDEMNIFICATION

   73

12.1

  

INDEMNIFICATION BY PFIZER

   73

12.2

  

INDEMNIFICATION BY ADOLOR

   74

12.3

  

LIABILITY CONTRIBUTION

   74

12.3.1

  

INDEMNIFICATION PROCEDURES

   74

12.3.2

  

U.S. PRODUCT LIABILITY

   74

12.4

  

PROCEDURE FOR INDEMNIFICATION

   75

12.4.1

  

NOTICE

   75

12.4.2

  

DEFENSE OF CLAIM

   75

12.5

  

ASSUMPTION OF DEFENSE

   76

12.6

  

INSURANCE

   76

12.7

  

LIMITATION OF LIABILITY

   76

ARTICLE 13

  

INTELLECTUAL PROPERTY

   77

13.1

  

INTELLECTUAL PROPERTY

   77

13.1.1

  

PFIZER TECHNOLOGY

   77

13.1.2

  

ADOLOR TECHNOLOGY

   77

13.1.3

  

JOINT OWNERSHIP

   77

13.1.4

  

INVENTORSHIP

   77

13.2

  

PROSECUTION AND MAINTENANCE OF PATENTS

   77

13.2.1

  

PROSECUTION AND MAINTENANCE OF ADOLOR PATENT RIGHTS

   77

13.2.2

  

RIGHT TO COMMENT

   77

13.2.3

  

PFIZER STEP-IN RIGHTS

   78

13.2.4

  

EXECUTION OF DOCUMENTS BY AGENTS

   78

13.3

  

PATENT INFRINGEMENT

   78

13.3.1

  

THIRD PARTY PATENT INVALIDITY CLAIMS

   78

13.3.2

  

INFRINGEMENT OF ADOLOR PATENT RIGHTS

   79

13.4

  

PARAGRAPH IV NOTICES

   79

13.5

  

PATENT TERM EXTENSION

   79

13.6

  

REGISTRATION OF LICENSE

   80

 

vi

 


TABLE OF CONTENTS

(continued)

 

          Page

ARTICLE 14

  

TERM AND TERMINATION

   80

14.1

  

TERM

   80

14.1.1

  

EXPIRATION

   80

14.1.2

  

PARTIAL TERMINATIONS

   80

14.2

  

TERMINATION FOR CAUSE

   80

14.2.1

  

TERMINATION FOR MATERIAL DEFAULT

   80

14.2.2

  

TERMINATION AS A RESULT OF INSOLVENCY

   81

14.2.3

  

TERMINATION BASED ON CLINICAL STUDY RESULTS

   81

14.3

  

PFIZER’S RIGHT TO TERMINATE FOR CONVENIENCE

   82

14.4

  

CHANGE OF CONTROL

   82

ARTICLE 15

  

EFFECTS OF TERMINATION

   82

15.1

  

EFFECT OF TERMINATION BY ADOLOR FOR CAUSE OR BY PFIZER VOLUNTARILY

   82

15.2

  

EFFECT OF TERMINATION BY PFIZER FOR CAUSE

   83

15.3

  

TERMINATION ASSISTANCE AND TECHNOLOGY TRANSFER

   83

15.3.1

  

TECHNOLOGY TRANSFER

   83

15.3.2

  

DELIVERY OF COLLATERAL MATERIALS

   84

15.3.3

  

ASSIGNMENT OF RIGHTS AND GRANT OF LICENSES

   85

15.3.4

  

INVENTORY

   86

15.3.5

  

TERMINATION DUE TO SERIOUS SAFETY ISSUE

   86

15.4

  

SURVIVAL

   86

ARTICLE 16

  

LIMITATIONS ON PURCHASES OF EQUITY SECURITIES

   86

16.1

  

PURCHASES OF EQUITY SECURITIES

   86

16.2

  

EXCEPTIONS FOR PURCHASING SECURITIES OF ADOLOR

   87

ARTICLE 17

  

MISCELLANEOUS

   89

17.1

  

RELATIONSHIP OF THE PARTIES

   89

17.2

  

FURTHER ASSURANCES

   89

17.3

  

FORCE MAJEURE

   89

17.4

  

GOVERNING LAW

   89

17.5

  

EXPERT DETERMINATION OF CERTAIN DISPUTES

   90

17.6

  

JURISDICTION

   90

17.7

  

ASSIGNMENT

   91

17.8

  

NOTICES

   91

 

vii

 


TABLE OF CONTENTS

(continued)

 

          Page

17.9

  

SEVERABILITY

   92

17.10

  

HEADINGS

   92

17.11

  

WAIVER

   92

17.12

  

ENTIRE AGREEMENT

   92

17.13

  

NO LICENSE

   93

17.14

  

THIRD PARTY BENEFICIARY

   93

17.15

  

COUNTERPARTS

   93

 

viii

 


CONFIDENTIAL

EXECUTION COPY

LICENSE AND COLLABORATION AGREEMENT

THIS LICENSE AND COLLABORATION AGREEMENT (the “ Agreement ”), dated as of December 4, 2007 (the “ Effective Date ”), is made by and between Adolor Corporation, a corporation organized and existing under the laws of the State of Delaware and having its principal office at 700 Pennsylvania Drive, Exton, Pennsylvania 19341 (“ Adolor ”), and Pfizer Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal office at 235 East 42nd Street, New York, New York 10017-5755 (“ Pfizer ”). Adolor and Pfizer are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

INTRODUCTION

WHEREAS, Pfizer has extensive experience and expertise in the development and commercialization of pharmaceutical products;

WHEREAS, Adolor has an ongoing research program in the field of Delta Compounds and has developed certain intellectual property in this field;

WHEREAS, Adolor desires to collaborate with Pfizer on the development and commercialization of the Licensed Products; and

WHEREAS, Pfizer desires to collaborate with Adolor on the development and commercialization of the Licensed Products, and to obtain licenses in the Territory to the Adolor Technology.

NOW, THEREFORE, in consideration of the foregoing premises and the representations, covenants and agreements contained herein, Adolor and Pfizer, intending to be legally bound, agree as follows:

ARTICLE 1 DEFINITIONS

For purposes of this Agreement, the following initially capitalized terms, whether used in the singular or plural, shall have the following meanings:

1.1ADL 5747 ” means ** .

1.2ADL 5859 ” means ** .

1.3Adolor Confidential Information ” means Confidential Information for which Adolor is the Disclosing Party.

1.4Adolor Delta Compound ” means a Delta Compound contributed by Adolor to the Collaboration, including ADL 5859 and ADL 5747.

 

2

 


1.5Adolor Improvements ” means any Improvements that are invented during the Term solely by Adolor, or its Affiliates, agents, or sublicensees or by Third Parties acting on its behalf.

1.6Adolor Know-How ” means Know-How that is either Controlled by Adolor on the Effective Date or comes within Adolor’s Control during the Term (other than Pfizer Know-How pursuant to the licenses granted hereunder) and is necessary or useful for the Development, manufacture, use or Commercialization of any Licensed Product or Named Compound, including unpatented Adolor Improvements.

1.7Adolor Patent Costs ” means all Patent Costs incurred in filing, prosecuting and maintaining Adolor Patent Rights.

1.8Adolor Patent Rights ” means any Patent Rights containing one or more claims that cover the composition of matter of a Named Compound or Licensed Product, or the manufacture or formulation of the foregoing, or use of a Named Compound or Licensed Product for a Named Indication, or any Patent Rights otherwise necessary or useful for the Development, manufacture, use or Commercialization of any Licensed Product for a Named Indication, which are Controlled by Adolor as of the Effective Date or come within Adolor’s Control during the Term (other than Pfizer Patent Rights pursuant to the licenses granted hereunder), including any Patent Rights claiming Adolor Improvements or Joint Improvements. For purposes of this Agreement, Adolor Patent Rights shall not include the ** unless Adolor grants Pfizer a sublicense to the ** pursuant to a separate agreement or an amendment to this Agreement. A list of Adolor Patent Rights as of the Effective Date, which list may be updated from time-to-time, is set forth on Schedule 1.8 .

1.9Adolor Technology ” means Adolor Patent Rights and Adolor Know-How.

1.10Affiliate ” of a Party means any Person, whether de jure or de facto, which directly or indirectly controls, is controlled by, or is under common control with such Party for so long as such control exists. For purposes of this definition, “control” of a Person means (including, with correlative meanings, “controlled by,” “controlling” and “under common control with”) the possession of (a) the power to direct or cause the direction of the management and policies of such Person, or (b) ownership of at least fifty percent (50%) of the securities or comparable equity interest (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to vote on or direct the affairs of the Person.

1.11Business Combination Transaction ” means, with respect to a Party, the acquisition by such Party or any of its Affiliates of, or merger or consolidation of such Party with, or the acquisition of a Party by, a Third Party or any business unit of a Third Party.

1.12Business Day ” means any day that is not a Saturday, Sunday or day on which banking institutions in New York, New York or Philadelphia, Pennsylvania, are authorized by Law to remain closed.

 

3

 


1.13Calendar Quarter ” means for each Calendar Year, each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided, however, that the first Calendar Quarter for the first Calendar Year shall extend from the Effective Date to the end of the first complete calendar quarter thereafter.

1.14Calendar Year ” means, for the first calendar year, the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31.

1.15Call ” means a personal, face-to-face visit by a Sales Representative to a member of the Target Audience who is legally permitted to prescribe prescription drugs in the United States during which such Sales Representative Details a Licensed Product. The Parties may, by mutual agreement, designate additional types of Calls.

1.16Change of Control ” means with respect to a Party:

1.16.1 the acquisition by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) (a “ Specified Person ”) of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934, as amended; it being understood that “beneficial ownership” shall also include any securities which any Person or any of such Person’s Affiliates has the right to acquire (whether such right is exercisable immediately or only after the passage of time, pursuant to any agreement, arrangement, understanding, or upon the exercise of conversion right, exchange rights, warrants or options, or otherwise) of fifty percent (50%) or more of either (a) the then outstanding common stock of such Party or (b) the combined voting power of the then outstanding voting securities of such Party;

1.16.2 the consummation by a Party of any Business Combination Transaction, unless immediately following such Business Combination Transaction, the individuals and entities who were the beneficial owners, respectively, of the outstanding common stock and outstanding voting securities of such Party immediately prior to such Business Combination Transaction beneficially own, directly or indirectly (including, without limitation, through one or more holding companies or subsidiaries), fifty percent (50%) or more of, respectively, the outstanding common stock and the combined voting power of the outstanding voting securities, as the case may be, of the corporation or other entity resulting from such Business Combination Transaction (including a corporation or other entity which as a result of such transaction owns the then outstanding securities of such Party or all or substantially all of such Party’s assets either directly or through one or more subsidiaries);

1.16.3 a Party or any of its Affiliates sells or transfers to any Specified Person(s) (other than the other Party or its Affiliates) in one or more related transactions properties or assets representing all or substantially all of such Party’s business to which this Agreement relates at the time of such sale or transfer; or

 

4

 


1.16.4 the individuals who, as of the Effective Date, constitute the board of directors of such Party (the “ Incumbent Board ”) ceasing for any reason to constitute fifty percent (50%) or more of the board of directors of such Party; provided, that any individual becoming a director subsequent to the Effective Date whose election, or nomination for election by such Party’s stockholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Specified Person other than the board of directors of such Party.

1.17Claims ” means all charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands.

1.18Clinical Studies ” means Phase 1 Studies, Phase 2 Studies or Phase 3 Studies.

1.19Collaboration ” means the joint efforts of Adolor and Pfizer to Develop and Commercialize Named Compounds for Named Indications pursuant to this Agreement.

1.20Collaboration Inclusion Date ” means, with respect to a given Unnamed Compound, (a) in the case of the exercise of the ** , the date on which ** with respect to such Unnamed Compound, (b) in the case of the exercise of the ** , the date on which the first ** commences with respect to such Unnamed Compound, (c) in the case of the exercise of the ** , the date on which the first ** commences with respect to such Unnamed Compound, or (d) in the case of the exercise of the ** , the date of completion of the ** that triggered the exercise of such ** . A Clinical Study is deemed to “commence” upon enrolment of the first patient in such Clinical Study.

1.21Collateral Materials ” means, with respect to a Named Compound or Licensed Product, information, data, or images reduced to a tangible form (which, for the avoidance of doubt, shall include electronic form) to the extent relating exclusively to such Named Compound or Licensed Product. By way of example and not limitation, Development Plans, NDAs, Regulatory Materials, Commercialization Plans, Licensed Product Training Materials and Promotional Materials are all considered “Collateral Materials.”

1.22Combination Product ” means a Licensed Product containing a Named Compound and one or more other therapeutically active ingredients.

1.23Commercialization ” means any and all activities directed to marketing, promoting, distributing, offering for sale and selling a Licensed Product, importing a Licensed Product (to the extent applicable) and conducting Phase 4 Studies, including, without limitation, Co-Promoting. When used as a verb, “ Commercialize ” means to engage in Commercialization.

1.24Commercially Reasonable Efforts ” means, with respect to a Party, the efforts and resources which would be used (including without limitation the promptness with which such efforts and resources would be applied) by that Party in Developing, manufacturing,

 

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promoting or Commercializing its own pharmaceutical products that are of comparable market potential to the Licensed Product, taking into account all relevant factors including product labeling or anticipated labeling, present and future market potential, past performance of the Licensed Product and such Party’s own pharmaceutical products that are of similar market potential, financial return, medical and clinical considerations, present and future regulatory environment and competitive market conditions, and the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), all as measured by the facts and circumstances at the time such efforts are due. Commercially Reasonable Efforts require that a Party, at a minimum, assign responsibility for such obligations to qualified employees, set annual goals and objectives for carrying out such obligations, and allocate appropriate resources designed to meet such goals and objectives. ** .

1.25Committee ” means the JSC, JDC, USCC or JSCC as the case may be.

1.26Confidential Information ” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, electronic or other form, provided by one Party (the “ Disclosing Party ”) to the other Party (the “ Receiving Party ”) pursuant to the letter agreements between Adolor and Pfizer dated June 19, 2007 and September 18, 2007, this Agreement or generated pursuant to this Agreement, including, but not limited to, information relating to the Disclosing Party’s existing or proposed research, development efforts, patent applications, business or products, the terms of this Agreement and any other materials, all of which are non-public. Notwithstanding the foregoing sentence, Confidential Information shall not include any information or materials that:

1.26.1 were already known to the Receiving Party or its Affiliate (other than under an obligation of confidentiality to the Disclosing Party) at the time of disclosure by the Disclosing Party to the extent such Receiving Party has documentary evidence to that effect;

1.26.2 were generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

1.26.3 became generally available to the public or otherwise part of the public domain after its disclosure or development, as the case may be, and other than through any act or omission of the Receiving Party in breach of the Receiving Party’s confidentiality obligations under this Agreement;

1.26.4 were disclosed to the Receiving Party or its Affiliate, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or

1.26.5 were independently discovered or developed by or on behalf of the Receiving Party or its Affiliate without the use of the Confidential Information belonging to the Disclosing Party, as demonstrated by the Receiving Party through documentary evidence.

1.27Control ” or “ Controlled ” means, with respect to any: (a) material, item of information, method, data or other Know-How, or (b) intellectual property right, the possession

 

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(whether by ownership or license, other than a license pursuant to this Agreement) by a Party or its Affiliates of the ability to grant to the other Party access and/or a license as provided herein under such item or right without violating the terms of any agreement or other arrangement with any Third Party existing at the applicable time.

1.28Co-Promotion ” means those Detailing and other activities undertaken by a pharmaceutical company’s sales force in concert with at least one other pharmaceutical company’s sales force to implement the Commercialization Plans and strategies with respect to a particular prescription pharmaceutical product under a single trademark. When used as a verb, “Co-Promote” shall mean to engage in such activities.

1.29Cost of Goods ” means Manufacturing Costs, calculated annually as a “standard cost,” plus, as applicable, (a) Manufacturing Cost variances between the standard cost components of Manufacturing Costs and the actual costs incurred, (b) Out-of-Pocket Costs and Expenses directly related to shipping of finished Licensed Product to the final warehouse prior to sale of such Licensed Product to an unaffiliated Third Party in the United States; and (c) other non-standard direct and identifiable costs such as process improvements, obsolete inventory, inventory revaluation, and expense portions of capital projects. Cost of Goods shall be calculated in accordance with GAAP and Pfizer’s policies and procedures that it uses for its other products, in each case as consistently applied.

1.30Country ” means any generally recognized sovereign entity.

1.31Delta Compound ” means any compound or molecule that binds with at least nanomolar affinity and which has greater than ** selectivity for the delta opioid receptor versus the kappa opioid receptor, mu opioid receptor or any other pharmacologically relevant receptor. For clarity, “Delta Compound” refers to agonists, not antagonists or inverse agonists and should have no significant pharmacological efficacy in functional assays for mu or kappa receptor agonist activity at concentrations ** in a delta functional assay.

1.32Detail ” or “ Detailing ” means, with respect to a Licensed Product, the activity undertaken by a Sales Representative during a Call to a member of the Target Audience at such member’s professional offices or in hospitals (including at hospital displays), describing the FDA-approved uses, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of such Licensed Product. With respect to certain group or institution Licensed Product presentations, Exhibit A sets forth how such presentations will be counted for determination of the number of Details. A Detail does not include (a) a reminder presentation or (b) a sample drop. Details shall be measured by each Party’s internal recording of such activity; provided, that such measurement shall be on the same basis as the recording Party’s measurement for its Sales Representatives’ detailing of such recording Party’s other products, if any, consistently applied throughout the Term. If a Party has no other marketed products, it will establish a basis of internal recording of Details that is reasonable as a basis of recording Details.

1.33Detail Cost ” means ** per Detail in the U.S. commencing with the Effective Date. Throughout the Term, the Detail Cost for the previous Calendar Year shall be amended on the first Business Day of each Calendar Year with effect for the then-current Calendar Year, by a

 

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factor equal to the rate of change for the previous Calendar Year in the Producer Price Index as published by the Bureau of Labor Statistics of the U.S. Department of Labor.

1.34Development ” or “ Develop ” means preclinical and clinical drug development activities, including, among other things, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, manufacturing for Clinical Studies, preclinical studies, Clinical Studies, regulatory filing submission and approval, and regulatory affairs related to the foregoing. When used as a verb, “Develop” means to engage in Development. For clarity, Development does not include Phase 4 Studies.

1.35Development Costs ” of a Licensed Product means all Out-of-Pocket Costs and Expenses for work required for Development of such Licensed Product, other than amounts related solely to Development of such Licensed Product in the ROW (including preclinical, clinical, regulatory and manufacturing activities), in each case only to the extent provided for in an approved Development Plan or otherwise approved in advance by the Joint Development Committee or Joint Steering Committee. Development Costs shall consist of:

1.35.1 Out-of-Pocket Costs and Expenses incurred (a) to a Third Party, in connection with all Development activities performed in accordance with the Development Plan; (b) in connection with regulatory submissions; or (c) for process development of the manufacturing process for the Licensed Product;

1.35.2 the Out-of-Pocket Costs and Expenses of clinical supplies for such Clinical Studies or activities as agreed in the Development Plan, which costs shall consist of: (a) the Out-of-Pocket Costs and Expenses incurred in purchasing clinical and pre-clinical supplies, including the Named Compound, utilized in Development, (b) Out-of-Pocket Costs and Expenses incurred in purchasing comparator drug(s) and in packaging comparator drug(s) and/or the Named Products, and (c) shipping clinical supplies to centers or disposal of clinical supplies; and

1.35.3 such other Out-of-Pocket Costs and Expenses as the Parties may agree upon in writing from time to time.

1.36Development Plan ” for a Licensed Product means: (a) the written comprehensive plan for the Development of such Licensed Product through filing for Marketing Authorization, including activities designed to generate the preclinical, process development/manufacturing scale-up, clinical and regulatory information required for filing Marketing Authorization Applications and managing any contracted Third Party resources engaged to carry out any of the foregoing activities, and (b) a budget for Development Costs through filing for Marketing Authorization. The initial Development Plans for Licensed Products containing ADL 5859 and ADL 5747 are attached hereto as Schedule 1.36 , as they may be amended and updated in accordance with Section 5.3 of this Agreement.

1.37Distribution Expenses ” means ** of Net Sales of a Licensed Product in the U.S. for warehousing and distribution of commercial supplies of the Licensed Product to Third Party customers, including: (a) distributor customer services, (b) order entry, (c) billing, (d) insurance,

 

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freight and transportation for delivery of the Licensed Product to the end user, and (e) credit and collection services.

1.38EMEA ” means the European Medicines Agency and any successor agency having substantially the same functions.

1.39Expert ” means a mutually acceptable, disinterested, conflict-of-interest-free individual not affiliated with either Party or its Affiliates who, with respect to a dispute referred to such Expert in accordance with this Agreement, possesses the appropriate expertise in the pharmaceutical industry to resolve such dispute. The Expert shall not be or have been at any time an Affiliate, employee, consultant (during the previous five (5) years), officer or director of either Party or any of its Affiliates.

1.40Expert Matter ” means any dispute referred to an Expert pursuant to Section 4.1.4(b) or otherwise referred to an Expert by mutual agreement of the Parties.

1.41FDA ” means the U.S. Food and Drug Administration and any successor agency thereto.

1.42FD&C Act ” means the U.S. Federal Food, Drug, and Cosmetic Act, as amended from time to time (21 U.S.C. §§ 301 et seq.), together with any rules and regulations promulgated thereunder.

1.43Field ” means all therapeutic, prognostic and diagnostic applications for all Named Indications for human and non-human purposes for Named Indications.

1.44First Commercial Sale ” of a Licensed Product means the first shipment of such Licensed Product in quantities customarily required for a pharmaceutical product launch sold to a Third Party by Pfizer, Pfizer’s Affiliates, or Pfizer’s sublicensees in any Country after receipt of Marketing Authorization (and, where applicable, Price Approval) for such Licensed Product in such Country.

1.45Generic Competition ” means, with respect to a Licensed Product and on a Country-by-Country basis, a decrease of Net Sales in a Pfizer Quarter resulting from sales of a Generic Product from the level of Net Sales of the Pfizer Quarter prior to the first entry of such Generic Product for such Licensed Product in such Country by more than ** . For clarity, there shall be deemed no Generic Competition in any Pfizer Quarter if the decrease of quarterly Net Sales, if any, compared to the Pfizer Quarter prior to the first entry of such Generic Product is less than ** .

1.46Generic Product ” means, on a Country-by-Country basis and Licensed Product-by-Licensed Product basis, a drug product independently developed by a Third Party that: (a) contains the same active pharmaceutical ingredient(s) as the Licensed Product, (b) can reasonably be or is reasonably used for the same indication or indications for which such Licensed Product is approved, and (c) (i) for purposes of the United States, is approved in reliance on the prior approval of a Licensed Product as determined by the FDA, or (ii) for

 

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purposes of a country outside the United States, is approved in reliance on the prior approval of a Licensed Product as determined by the applicable Regulatory Authority.

1.47GCPs ” means the then-current standards, practices and procedures promulgated or endorsed by the FDA for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials as set forth in the guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures in jurisdictions outside the U.S., as they may be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

1.48GLPs ” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the U.S., as they may be updated from time to time.

1.49GMPs ” means the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., as they may be updated from time to time. GMPs shall include applicable quality guidelines promulgated under the International Conference on Harmonization.

1.50Governmental Authority ” means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision.

1.51Improvement ” means any invention, discovery, or improvement (whether patentable or not) invented by or on behalf of a Party during the Term to the extent covering a Named Compound or Licensed Product.

1.52IND ” means an Investigational New Drug Application, as defined in the FD&C Act, that is required to be filed with the FDA, or similar application or submission that is required to be filed with any foreign Regulatory Authority before beginning clinical testing of a Licensed Product in human subjects.

1.53Joint Improvement ” means an Improvement that is invented jointly by employees and/or agents of both Adolor and Pfizer or their Affiliates.

1.54Know-How ” means any unpatented technology, technical information, know-how and materials, including without limitation all biological, chemical, pharmacological, toxicological, clinical, assay and other information, data, discoveries, inventions, improvements, processes, formulae and trade secrets, patentable or otherwise.

1.55Laws ” means laws, rules and regulations (including any rules, regulations, guidelines or other requirements of the Regulatory Authorities applicable to the Development,

 

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manufacturing or Commercialization of Named Compounds or Licensed Products) that may be in effect from time to time.

1.56Licensed Product ” means any pharmaceutical product containing a Named Compound, alone or in combination with one or more therapeutically active ingredients. Two (2) pharmaceutical products that contain the identical active ingredient(s) shall be deemed to be the same Licensed Product where the change to the initial Licensed Product does not require the filing and approval of a new MAA, but rather requires the filing and approval of a supplement to a then-existing MAA for the Licensed Product.

1.57Losses ” means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses, lost profits and expenses (including without limitation court costs, interest and reasonable fees of attorneys, accountants and other experts) incurred by or awarded to Third Parties and required to be paid to Third Parties with respect to a Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, together with all documented Out-of-Pocket Costs and Expenses incurred in complying with any judgments, orders, decrees, stipulations and injunctions that arise from or relate to a Claim of a Third Party.

1.58Major EU Countries ” means France, Germany, Italy, Spain and the United Kingdom.

1.59Major Market Countries ” means the United States, Japan, and Major EU Countries.

1.60Manufacturing Costs ” means costs to supply Licensed Product (a) supplied by an unaffiliated Third Party or (b) manufactured directly by a Party or an Affiliate of a Party. In the case of (a), Manufacturing Costs shall be a “standard cost” per unit (calculated for each calendar year of the Term), which standard cost shall include (i) the amount paid to such Third Party, plus (ii) direct and identifiable personnel compensation and benefits and direct and identifiable Out-of-Pocket Costs incurred by the manufacturing Party (i.e., the Party responsible for overseeing the manufacturing of the Third Party) in connection with quality assurance, supply chain management and similar activities comprising the manufacturing Party’s oversight of the manufacturing process of the Third Party. In the case of (bi), Manufacturing Costs shall be a “standard cost” per unit (calculated annually and at a time to align with the Parties’ internal budget processes), which standard cost shall include the cost of raw materials, direct and identifiable labor, and other direct and identifiable variable costs and appropriate direct and identifiable costs (or appropriate allocation thereof) for equipment pools, plant operations and plant support services. The costs for plant operations and support services would include utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities. Standard costs shall be calculated in accordance with GAAP and Pfizer’s policies and procedures for its other products, in each case consistently applied. The plant operations and support services costs shall be allocated consistent with GAAP and the other Pfizer products in that facility. Costs which cannot be linked to a specific activity supporting

 

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Product manufacturing, such as charges for corporate overhead which are not controllable by the manufacturing plant, shall not be included in standard cost.

1.61Marketing Authorization Application ” or “ MAA ” means, with respect to a Country, the regulatory authorization required to market and sell a Licensed Product in such Country as granted by the relevant Regulatory Authority, including any NDA filed with the FDA or any marketing authorization application filed with the EMEA.

1.62Marketing Authorization ” means approval by a Regulatory Authority for sale of a Licensed Product.

1.63Marketing Expenses ” of a Licensed Product means all Out-of-Pocket Costs and Expenses, whether incurred by Adolor or its Affiliates, or Pfizer or its Affiliates, to the extent provided for in an approved Commercialization Plan or otherwise approved in advance by the Joint Steering Committee, and solely to the extent related to marketing such Licensed Product in the United States, consisting of:

1.63.1 Marketing, promotion and advertising (including agency fees) through any means (including consumer-directed advertising, physician-directed advertising, journal, newspaper, radio, internet or place-based advertisements, promotional literature, patient education, field and headquarters’ grants, exhibits, direct mail, advisory boards, symposia, congress activities and dinner programs);

1.63.2 Sampling and promoting such Licensed Product, speakers’ programs and symposia, but excluding all costs and expenses incurred in retaining contract sales forces for such Licensed Product unless otherwise mutually agreed by the Parties;

1.63.3 Conducting Phase 4 Studies;

1.63.4 Conducting primary and secondary market research;

1.63.5 Preparing and producing Promotional Materials for distribution and materials and programs used for ongoing training of Sales Representatives and of sales trainers;

1.63.6 Conducting recalls of Licensed Product to the extent provided in Section 8.6;

1.63.7 Manufacturing Costs of Samples, and costs relating to the destruction of unused Samples; and

1.63.8 Such other Out-of-Pocket Costs and Expenses as the Parties may agree upon in writing from time to time.

1.64Material Default ” means:

 

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1.64.1 any default by any Party hereto of its representations, warranties, covenants, agreements or other performance obligations under this Agreement (other than a payment obligation) that is (a) material to this Agreement, taken as a whole, and (b) shall have continued for ** after notice thereof was provided to the alleged defaulting Party by the non-defaulting Party (or, if such default cannot be cured within such ** period, if the alleged defaulting Party does not promptly commence and diligently continue all reasonable actions to cure such defaults during such ** period, or does not materially cure such default within ** after notice thereof was provided to the alleged defaulting Party); or

1.64.2 any default by any Party hereto of its payment obligations hereunder that shall have continued for ** after notice thereof was provided to the alleged defaulting Party by the non-defaulting Party; provided that, in the event of a good faith payment dispute, such ** cure period shall be extended for an additional ** to resolve such dispute if the alleged defaulting Party has paid all undisputed amounts when due and provided the non-defaulting Party with a reasonably detailed written explanation of the alleged defaulting Party’s basis for disputing the payment obligation within the ** period following the notice of the default by the non-defaulting Party. The alleged defaulting Party shall pay interest on the final adjudicated amount due pursuant to Section 7.13 from the date that such payment was originally due.

1.64.3 Notwithstanding anything to the contrary contained herein, for purposes of determining the existence of any “Material Default,” no Party shall be deemed to be in material breach or material default if its actions or omissions resulted from (a) mutual agreement in writing by the Parties or (b) required compliance with any applicable Law.

1.65Named Compounds ” means any Delta Compounds set forth on Schedule 1.65 , as amended from time to time pursuant to the terms of this Agreement. As of the Effective Date the Named Compounds shall be ADL 5859 and ADL 5747.

1.66Named Indications ” means indications set forth on Schedule 1.66 , as amended from time to time pursuant to the terms of this Agreement. As of the Effective Date the Named Indications shall be pain.

1.67NDA ” means a new drug application or supplemental new drug application or any amendments thereto submitted to the FDA in the United States.

1.68NDA Acceptance ” means the written notification by the FDA that the NDA has met all the criteria for filing acceptance pursuant to 21 C.F.R. § 314.101.

1.69Net Profit/Net Loss ” means, as determined in accordance with GAAP, with respect to a Licensed Product in the United States, Net Sales of such Licensed Product less the following: (a) Cost of Goods, (b) Royalties, if any, paid by Adolor or Pfizer to Third Parties in accordance with Section 7.7.2 or 7.7.3, (c) Sales Expenses, (d) Distribution Expenses, (e) Marketing Expenses, (f) Patent Costs relating to each of Adolor Patent Rights in the U.S. and Pfizer Patent Rights in the U.S., and (g) Development Costs. For the avoidance of doubt, no individual cost or expense shall be counted more than once in calculating Net Profit/Net Loss.

 

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1.70Net Sales ” of a Licensed Product means, as determined in accordance with GAAP, the aggregate gross amount invoiced on account of sales of such Licensed Product by Pfizer or any of its Affiliates or their sublicensees to a Third Party less the following relating to such sale to the extent actually paid, granted or accrued:

1.70.1 credits or allowances as a result of billing errors, rejected goods, damaged or defective goods, recalls, retroactive price adjustments, or returns;

1.70.2 trade, quantity and cash discounts or rebates;

1.70.3 credits, volume rebates, charge-back and prime vendor rebates;

1.70.4 actual bad debts;

1.70.5 discounts, rebates, reimbursements or similar payments to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, Governmental Authorities, or other institutions or health care organizations or arising in connection with any Pfizer Discount or Savings Program (as defined below); and

1.70.6 any tax, tariff, customs duty, excise or other duty or other governmental charge (other than a tax on income) levied on the sale, transportation or delivery of a Licensed Product and borne by the seller thereof.

Net Sales shall be determined from books and records maintained by Pfizer in accordance with GAAP, as consistently applied with respect to sales of all its prescription pharmaceutical products.

For purposes of this definition of “Net Sales” only, “ Pfizer Discount or Savings Program ” means any discount, rebate or reimbursement program applicable to a Licensed Product under which Pfizer or its Affiliates provides to low income, uninsured or other patients the opportunity to purchase Pfizer pharmaceutical products at discounted prices.

In the case of any sale for value, such as barter or counter-trade, of a Licensed Product, or part thereof, other than in an arm’s-length transaction exclusively for cash, Net Sales shall be deemed to be the Net Sales at which substantially similar quantities of such Licensed Product are sold for cash in an arm’s-length transaction.

Notwithstanding the foregoing, Net Sales shall not be reduced by customs or excise taxes, import duties, sales taxes and other taxes or duties related to the active ingredient in a Licensed Product or sales of a Licensed Product other than in finished form, all of which shall be deemed expenses incurred in connection with the manufacture of a Licensed Product.

Pfizer shall have the sole right to price, including discounting, the Licensed Products and Pfizer shall not be prohibited from offering the Licensed Products in a discounting program that includes a portfolio of other Pfizer products (“ Portfolio Discounting ”); provided that: ** .

 

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In the event a Licensed Product is sold as a Combination Product, Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A/(A+B), where A is the weighted (by sales volume) average sale price in a particular Country of the Named Compound in such Combination Product when sold separately in finished form and B is the weighted (by sales volume) average sale price in that Country of the other product(s) sold separately in finished form. In the event no such separate sales are made by Pfizer or its Affiliates or sublicensees, Net Sales of the Combination Product shall be calculated in a manner to be negotiated and agreed upon by the Parties, reasonably and in good faith, prior to any sale of such Combination Product, which shall be based upon the relative value contributed to the Combination Product of each of the active components of such Combination Product.

1.71Opt Out ” means the ** .

1.72Out-of-Pocket Costs and Expenses ” means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with GAAP), other than Affiliates or employees, by either Party.

1.73Patent Costs ” means all Out-of-Pocket Costs and Expenses incurred in filing, prosecuting and maintaining Patent Rights.

1.74Patent Rights ” means all patents and patent applications, including any continuations, continuations-in-part, divisions, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent, registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing, or, as applicable, portions thereof or individual claims therein.

1.75Patent Term Extension ” means any term extensions, supplementary protection certificates, and equivalents thereof, offering patent protection beyond the initial term with respect to any issued Patent Rights. For clarity, pediatric exclusivity under Section 505(A) of the FDA Modernization Act of 1997 shall not be deemed Patent Term Extension.

1.76Person ” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization.

1.77Pfizer Confidential Information ” means Confidential Information for which Pfizer is the Disclosing Party.

1.78Pfizer Delta Compound ” means a Delta Compound contributed by Pfizer to the Collaboration.

1.79Pfizer Improvements ” means any Improvements that are invented during the Term solely by Pfizer, or its Affiliates, agents, or sublicensees or by Third Parties acting on its behalf.

 

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1.80Pfizer Know-How ” means Know-How that is either Controlled by Pfizer on the Effective Date or comes within Pfizer’s Control during the Term (other than Adolor Know-How pursuant to the licenses granted hereunder) and is necessary or useful for the Development, manufacture, use or Commercialization of any Licensed Product or Named Compound, including unpatented Pfizer Improvements.

1.81Pfizer Patent Costs ” means Patent Costs incurred in connection with filing, prosecuting and maintaining Pfizer Patent Rights.

1.82Pfizer Patent Rights ” means any Patent Rights containing one or more claims that cover the composition of matter of a Named Compound or Licensed Product or the manufacture or formulation of the foregoing, or use of a Named Compound or Licensed Product for a Named Indication, or any Patent Rights otherwise necessary or useful for the Development, manufacture, use or Commercialization of any Licensed Product for a Named Indication, which are Controlled by Pfizer as of the Effective Date or come within Pfizer’s Control during the Term (other than Adolor Patent Rights pursuant to the licenses granted hereunder), including any Patent Rights claiming Pfizer Improvements or Joint Improvements.

1.83Pfizer Quarter ” means each of the four (4) thirteen (13) week periods (i) with respect to the United States, commencing on January 1 of any calendar year, and (ii) with respect to any Country in the Territory other than the United States, commencing on December 1 of any calendar year.

1.84Pfizer Year ” means the twelve (12) month period (i) with respect to the United States, commencing on January 1 of any calendar year, and (ii) with respect to any Country in the Territory other than the United States, commencing on December 1 of any calendar year.

1.85Pfizer Technology ” means Pfizer Patent Rights and Pfizer Know-How.

1.86Phase 1 Study ” means, with respect to a Licensed Product, a clinical study identified as a Phase 1 Study in the Development Plan and conducted in humans on a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokinetic properties, and clinical pharmacology of such pharmaceutical product, and that is consistent with 21 C.F.R. § 312.21(a).

1.87Phase 2 Study ” means, with respect to a Licensed Product, a clinical study identified as a Phase 2 Study in the Development Plan and conducted in human patients designed to evaluate clinical efficacy and safety for such product for one or more indications, as well as to obtain an understanding of the dosage regimen before embarking on Phase 3 Studies, and that is consistent with 21 C.F.R. § 312.21(b).

1.87.1Phase 2a Study ” means a Phase 2 Study identified as a Phase 2a Study in the applicable Development Plan.

1.87.2Phase 2b Study ” means a Phase 2 Study identified as a Phase 2b Study in the applicable Development Plan.

 

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1.88Phase 3 Study ” means, with respect to a Licensed Product, a clinical study identified as a Phase 3 Study in the Development Plan and conducted as a pivotal trial for purposes of filing a Marketing Approval Application for a Licensed Product that provides for the clinical study of such Licensed Product on sufficient numbers of patients to confirm with statistical significance the efficacy, and confirm the safety of such Licensed Product sufficient to support such Marketing Approval Application for such Licensed Product, and is consistent with 21 C.F.R. § 312.21(c).

1.89Phase 4 Study ” means a study for a Licensed Product that is initiated in a Country after receipt of a Marketing Authorization for such Licensed Product in such Country and is principally intended to support the marketing and Commercialization of such Licensed Product, including without limitation investigator initiated trials, clinical experience trials and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization. For clarity, no Phase 3 Studies are included in this definition of Phase 4 Studies.

1.90Price Approval ” means, in any Country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

1.91Promotional Materials ” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than the Licensed Product package insert), including all written, graphic, electronic, audio and video pieces and including journal advertisements, direct mail, direct-to-consumer advertising, internet postings, broadcast advertisements and sales aids, relating to the Licensed Products in the United States.

1.92Regulatory Approvals ” means all approvals (including, without limitation, INDs, Marketing Authorizations and supplements and amendments thereto), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity necessary for the Development or Commercialization of the Licensed Product, including clinical testing, importation, manufacture, distribution, use or sale of the Licensed Product in a given regulatory jurisdiction.

1.93Regulatory Authority ” means any applicable Governmental Authority responsible for the granting of Marketing Authorizations for a Licensed Product in a regulatory jurisdiction within the Territory, including, without limitation, the FDA and the EMEA.

1.94Regulatory Exclusivity ” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product other than a Patent Right, including, without limitation, rights conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto outside the U.S.

 

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1.95Regulatory Materials ” means any regulatory submissions, notifications, registrations, approvals and/or other filings and correspondence made to or with a Regulatory Authority, and any other records required to be maintained for possible audit by a Regulatory Authority, that are necessary or reasonably desirable to Develop, manufacture, promote, market, sell or otherwise Commercialize Licensed Products in the Territory.

1.96ROW ” means all the Countries of the world other than the United States.

1.97Royalty Term ” means on a Country-by-Country and Licensed Product-by-Licensed Product basis, the period beginning on the date of the First Commercial Sale of a Licensed Product and ending on the last day on which royalty payments are payable by Pfizer to Adolor pursuant to Section 7.6.

1.98Sales Expenses ” of a Party means the Detail Cost multiplied by the number of Details conducted by such Party in Detailing the applicable Licensed Product during the applicable period of time.

1.99Sales Representative ” means an employee of Adolor or Pfizer who engages in Detailing and other promotional efforts with respect to the Licensed Product and who has been trained by Adolor or Pfizer in accordance with this Agreement.

1.100Samples ” means Licensed Product packaged as samples and distributed to members of the Target Audience on a complimentary basis for use with patients in the United States and in accordance with all Laws.

1.101Target Audience ” means the target prescribers established by the USCC for the Sales Representatives to Detail, as included in the Commercialization Plan.

1.102Territory ” means ROW and the United States.

1.103Third Party ” means a Person who is not a Party or an Affiliate of a Party.

1.104 “**” means **.

1.105 “**” means **.

1.106Unnamed Compound ” means any Delta Compound that is not a Named Compound.

1.107United States ” or “ U.S. ” means the United States of America, and its territories and possessions.

1.108Valid Claim ” means any claim of (a) an issued and unexpired patent included within the Adolor Patent Rights that has not been revoked or held unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, and which has not been disclaimed, denied or admitted by Adolor to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b) a pending patent application within the Adolor Patent Rights that

 

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has not been cancelled, withdrawn, abandoned, or pending for more than ** after the earliest filing date to which such pending application claims priority; provided, however, when such patent issues based on such patent application, any claim contained therein shall be deemed a Valid Claim. If, in any Country, there should be two (2) or more such decisions conflicting with respect to the validity of the same claim, the decision of the higher or highest tribunal shall thereafter control; however, should the tribunals be of equal rank, then the decision or decisions upholding the claim shall prevail when the conflicting decisions are equal in number, and the majority of decisions shall prevail when the conflicting decisions are unequal in number.

1.109 Construction . Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “include,” “includes” and “including” are not limiting and mean include, includes and including, without limitation; (b) definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms; (c) references to an agreement, statute, Law or instrument defined or referred to herein mean such agreement, statute, Law or instrument as from time to time amended, modified or supplemented, including (in the case of agreements and instruments) by waiver or consent and (in the case of statutes and Laws) by succession of comparable successor statutes or Laws and all attachments thereto and instruments incorporated therein; (d) references to a person are also to its permitted successors and assigns; (e) references to an “Article,” “Section,” “Exhibit” or “Schedule” refer to an Article or Section of, or any Exhibit or Schedule to, this Agreement unless otherwise indicated; (f) the word “will” shall be construed to have the same meaning and effect as the word “shall”; and (g) the word “any” shall mean “any and all” unless otherwise indicated by context.

Other Defined Terms

 

Abandoned Adolor Patent Rights    13.2.3
Acquired Competing Product    3.1.2(a)
Acquiring Party    3.1.2(a)
Acquisition    16.2.2
Additional Proposal    3.3.1
Adolor    Preamble
Adolor Expenses    7.9.2
Adolor Indemnitees    12.1
Adolor Report    7.9.2
Adolor Sales Force    6.7.1
Adolor Sales Force Trainers    6.7.1
Adolor Sales Representatives    6.7.1
Adolor Targets    6.4
Agreement    Preamble
Alliance Manager    4.6
Annual Cost Sharing Opt Out    5.5.2(c)
Auditing Party    7.15
Collaboration Principles    4.7
Commercialization Plan    6.2.1
Commercialized Acquired Unnamed Compound    3.2.5
Commercialized Acquired Unnamed Compound Inclusion Option    3.2.5
Competing Product    3.1.1
Competing Products    3.1.1
Co-Promote Option    6.4
Courts    17.6
Detail Reporting Party    6.11.3
Detail Requirements    6.2.2(h)
Detail Shortfall Period    6.11.4(b)
Developing Party    3.2
Development Milestone    7.3.1
Disclosing Party    1.26
Due Date    7.13
Effective Date    Preamble
Estimated Pfizer Report    7.9.3
Exchange Act    16.1.1
Executives    4.1.4(a)

 

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Force Majeure Event    17.3
GAAP    7.10
HSR Act    11.2.3
Incumbent Board    1.16.4

**

   3.2.1
Indemnified Party    12.4.1
Indemnifying Party    12.4.1
Indication of Interest    3.2.5(b)
Initial Commercialization Plan    6.2.1
Initial Cost Sharing Opt Out    5.5.2(a)
Internal Detailing Report    6.11.2
JDC    4.2.1
Joint Development Committee    4.2.1
Joint Steering Committee    4.1.1
Joint Supply Chain Committee    4.4.1
JSC    4.1.1
JSCC    4.4.1
Manufacturing Transfer    9.2
Marketed Unnamed Compound    3.2.9
Medical Information Requests    6.12.4
New Collaboration Compound    3.2
New Collaboration Compound Options    3.2
Notification of Non Interest    3.1.2(b)
Offered Compound    3.2
Offeree Party    3.2
Opt Out Notice    5.5.2(c)
Option Costs    3.2.1(a)
Paragraph IV Notice    13.4
Parties    Preamble
Party    Preamble
Patent Challenge    2.5
PDMA    6.12.3
Pfizer    Preamble
Pfizer Discount or Savings Program    1.70.6
Pfizer Expenses    7.9.3
Pfizer Indemnitees    12.2
Pfizer Report    7.9.4
**    3.2.2
**    3.2.3
Portfolio Discounting    1.70.6
**    3.2.4
Product Marks    6.3
Receiving Party    1.26
Recording Party    7.15
Redacted Agreement    10.3
Responsible Party    7.14.2
Safe Harbor Regulations    6.12.3
Screening Option    3.5
SEC    16.1.2
Second Cost Sharing Opt Out    5.5.2(b)
Shortfall Party    6.11.4(a)
Specified Person    1.16.1
Standstill Provisions    16.2.1
Term    14.1.1
Third Party Agreement    3.2.8
Third Party Claim    12.4.1
Thirty Day LIBOR Rate    7.13
Training Program    6.7.2
Trigger Event    16.2.2
U.S. Commercialization Committee    4.3.1
U.S. IP Liability    12.3.3
U.S. Product Liability    12.3.2
**    7.7.2
USCC    4.3.1
**    3.1.2(b)(i)
**    3.1.2(b)(i)
VAT    7.14.2
Voting Securities    16.1.1
Withdrawal Notice    4.5
Withholding Party    7.14.1

 

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ARTICLE 2 LICENSE GRANTS; EXCLUSIVITY

2.1 License Grant to Pfizer .

2.1.1 Subject to the terms and conditions of this Agreement, Adolor hereby grants Pfizer an exclusive license (even as to Adolor), with the right to sublicense as provided in Section 2.4 under Adolor Technology, to make, have made, sell, offer to sell, import and use the Named Compounds and Licensed Products in the Field in the Territory.

2.1.2 Except for the rights granted to Pfizer under this Agreement, all right, title and interest in and to the Adolor Technology shall at all times remain with and be vested in Adolor. All rights with respect to any Adolor Technology that are not specifically granted herein shall remain with Adolor and subject to Sections 3.1 and 3.2, Adolor shall have the right to grant licenses to any Third Party under the Adolor Technology to make, have made, sell, offer to sell, import and use Unnamed Compounds and any product containing any Unnamed Compound outside of the Field in the Territory and Adolor shall have the right to grant such licenses to any Third Party as referred to in the last sentences of Sections 3.2.8 and 3.2.9. For clarity, the licenses and rights granted in this Agreement shall not be construed to convey any licenses or rights under the Adolor Patent Rights with respect to any active pharmaceutical ingredients other than Named Compounds.

2.2 License Grant to Adolor . Subject to the terms and conditions of this Agreement, Pfizer hereby grants Adolor a non-exclusive royalty-free license, with the right to sublicense as provided in Section 2.4 (a) under Pfizer’s rights in Adolor Technology, and (b) under the Pfizer Technology, in each case solely to the extent necessary to exercise its rights and perform its obligations pursuant to this Agreement.

2.3 Research License .

2.3.1 Without limiting any of the licenses granted in Section 2.1, Adolor hereby grants to Pfizer a nonexclusive, irrevocable, worldwide, royalty-free, perpetual license, including the right to sublicense to Affiliates, to use for all research purposes those portions of the Adolor Know-How (excluding any Patent Rights relating thereto) disclosed to Pfizer during the Term to the extent retained in the unaided memories of Pfizer’s employees and individual consultants who have had access to such Adolor Know-How; provided that Pfizer shall not have any right to use the Adolor Know-How for the sale or manufacture for sale of products or processes.

2.3.2 Without limiting any of the licenses granted in Section 2.2, Pfizer hereby grants to Adolor a nonexclusive, irrevocable, worldwide, royalty-free, perpetual license, including the right to sublicense to Affiliates, to use for all research purposes those portions of the Pfizer Know-How (excluding any Patent Rights relating thereto) disclosed to Adolor during the Term to the extent retained in the unaided memories of Adolor’s employees and individual consultants who have had access to such Pfizer Know-How; provided that Adolor shall not have any right to use the Pfizer Know-How for the sale or manufacture for sale of products or processes.

 

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2.3.3 The licenses granted in Section 2.3.1 and Section 2.3.2 shall not be construed as permitting either Party to use, disclose, publish or disseminate: (a) the identity of the other Party as the source of such Know-How, (b) any financial or statistical information, or business plans of the other Party, or (c) any drawings, designs or chemical formulae.

2.4 Sublicensing and Subcontracting .

2.4.1 Right to Sublicense .

(a) Adolor may not sublicense any of the rights granted under this Agreement without the prior written consent of Pfizer, such consent not to be unreasonably delayed, withheld, refused or conditioned, except to its Affiliates, which right shall automatically terminate when such Affiliate ceases to be an Affiliate of Adolor.

(b) Pfizer may not sublicense any of the rights granted under this Agreement without the prior written consent of Adolor, such consent not to be unreasonably delayed, withheld, refused or conditioned, except that Pfizer may, without prior written consent of Adolor, grant sublicenses to (i) its Affiliates, which right shall automatically terminate when such Affiliate ceases to be an Affiliate of Pfizer; and (ii) Third Parties, with respect to rights to Develop, import, market or sell in any Country other than a Major Market Country; subject to Adolor receiving the applicable royalties pursuant to this Agreement for Net Sales of such sublicensee.

(c) Each sublicense granted by Pfizer to a permitted sublicensee pursuant to Section 2.4.1(b) shall be subject and subordinate to the terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement and shall not in any way diminish, reduce or eliminate any of Pfizer’s obligations under this Agreement. Each sublicense agreement with permitted sublicensees shall contain the following provisions: (i) a requirement that such sublicensee submit applicable sales or other reports consistent with the requirements set forth in Section 7.9.6(c), (ii) a requirement to keep books and records, and permit Adolor to audit (either directly or through an independent auditor) such books and records, consistent with the requirement set forth in Section 7.15, (iii) a requirement that such sublicensee comply with the confidentiality and non-use provisions of ARTICLE 10 with respect to both Parties’ Confidential Information, (iv) a requirement to comply with all other applicable terms of this Agreement, (v) a provision prohibiting such sublicensee from further sublicensing except on terms consistent with this Section 2.4.1 and (vi) if such sublicensee will be performing Development activities for any Named Compound or Licensed Product, a requirement that each sublicensee allow Pfizer to inspect its facilities upon reasonable notice consistent with the requirements set forth in Section 5.6. Pfizer shall provide Adolor with a copy of each such sublicense agreement within thirty (30) days after the execution thereof, provided that Pfizer may redact confidential financial information from such sublicense agreement. For clarity, Pfizer does not have the right hereunder to grant any sublicensee a manufacturing license to manufacture the Named Compounds or Licensed Products.

 

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2.4.2 Right to Subcontract . Each Party may, subject to Section 6.10, subcontract its obligations under this Agreement to a Third Party as it would in the normal course of its business without the prior written consent of the other Party, except, in the Major Market Countries:

(a) neither Party may subcontract its obligations to create, oversee and manage the execution of the Development Plan without the prior written consent of the other Party;

(b) Pfizer may not subcontract, without prior written consent of Adolor:

(i) its obligations to create, oversee and manage the execution of the Commercialization Plan;

(ii) its obligations to prepare and submit regulatory filings and its dealings with Regulatory Authorities; and

(iii) its Detail Requirements, on a Country-by-Country basis, for a Licensed Product for a period beginning with the ** and ending on the **. **.

2.4.3 Liability for Affiliates, Sublicensees and Subcontractors . Each Party shall ensure that each of its Affiliates and permitted sublicensees or subcontractors accepts and complies with all of the applicable terms and conditions of this Agreement as if such Affiliates or permitted sublicensees or subcontractors were a party to this Agreement and each Party shall remain fully responsible for its Affiliates’ and permitted sublicensees’ or subcontractors’ performance under this Agreement.

2.5 Patent Challenge . Pfizer and its Affiliates hereby covenant and agree not to, directly or indirectly, commence or maintain any opposition proceeding, challenge the validity or enforceability of, or, without limiting Pfizer’s rights under Section 13.5, oppose any extension of or the grant of a supplementary protection certificate, with respect to any Adolor Patent Rights, or with respect to Adolor Patent Rights contained on Schedule 1.8 as of the Effective Date, actively participate in any interference proceeding (each such action, a “ Patent Challenge ”). Except to the extent the following is unenforceable under the Law of a particular Country where a patent application within the Adolor Patent Rights is pending or a patent within the Adolor Patent Rights is issued, Adolor shall be permitted to terminate this Agreement by written notice effective upon receipt if Pfizer or its Affiliates directly, or indirectly through a Third Party, commence or maintain any Patent Challenge. Pfizer shall include provisions in all agreements granting sublicenses of Pfizer’s rights hereunder providing that if the sublicensee or its Affiliates undertake a Patent Challenge with respect to any Adolor Patent under which the sublicensee is sublicensed, Pfizer shall be permitted to terminate such sublicense agreement in its entirety. If a sublicensee of Pfizer (or an Affiliate of such sublicensee) undertakes a Patent Challenge of any such Adolor Patent Right under which such sublicensee is sublicensed, then Pfizer upon receipt of notice from Adolor of such Patent Challenge may terminate the applicable sublicense agreement in its entirety. If Pfizer fails to so terminate such sublicense agreement, Adolor shall

 

23

 


terminate all licensed rights granted to Pfizer covered by such sublicense agreement and any sublicenses previously granted in such Country(ies) shall automatically terminate. Pfizer shall cooperate with Adolor’s reasonable requests to cause such terminated sublicensee to discontinue all activities under such sublicense agreement.

ARTICLE 3 EXCLUSIVITY; ACQUISITION OF UNNAMED COMPOUNDS;

ADDITION AND REMOVAL OF NAMED COMPOUNDS AND NAMED INDICATIONS

3.1 Exclusivity .

3.1.1 Non-Compete . During **, neither Party nor any of its Affiliates shall, directly or indirectly, by itself or through any Third Party, Develop or Commercialize any: (a) pharmaceutical product containing any Unnamed Compound for a Named Indication, or (b) pharmaceutical product (other than the Licensed Products pursuant to this Agreement) containing any Named Compound for any indication (pharmaceutical products described in (a) and (b), are each a “ Competing Product ” and collectively, the “ Competing Products ”). Notwithstanding the foregoing, each Party shall have the right to conduct research on Named Compounds for the purpose of developing Additional Indication Proposals, provided that such research does not include Clinical Studies or animal studies in primates.

3.1.2 Acquisition of a Competing Product .

(a) Notwithstanding the restrictions set forth in Section 3.1.1, in the event that a Party (the “ Acquiring Party ”) effects a Business Combination Transaction with a Third Party that as of the date of the closing of such transaction would be Developing or Commercializing a Competing Product in any Country in the Territory (such product, an “ Acquired Competing Product ”) or enters into any agreement with respect to any such Business Combination Transaction, and the Acquiring Party is informed by a Governmental Authority that it or, if applicable, its acquiror, will be required as a condition to such Business Combination Transaction either to (i) divest such Acquired Competing Product or (ii) divest its interest in the Collaboration, then not later than ** after receipt of notice of such requirement from such Governmental Authority, the Acquiring Party shall notify the other Party in writing of such requirement and whether the Acquiring Party intends to (1) divest such Acquired Competing Product or to (2) divest its interest in the Collaboration (x) if the Licensed Product under the Collaboration is Commercialized, by terminating this Agreement pursuant to Section 14.3 or selling its interest in the Collaboration pursuant to Section 3.1.2(b) below and (y) if the Licensed Product under the Collaboration is in the Development stage, solely with respect to Pfizer, by terminating this Agreement pursuant to Section 14.3, which divestiture, sale or termination may be conditioned upon the consummation of such Business Combination Transaction. If the Acquiring Party notifies that other Party that it intends to divest such Acquired Competing Product, the Acquiring Party shall have ** following the consummation of the Business Combination Transaction to divest such Acquired Competing Product; provided, that Pfizer shall continue its Development and/or Commercialization activities hereunder for such ** period.

 

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(b) If instead the Acquiring Party notifies the other Party that it intends to sell its interest in the Collaboration to the other Party, such notice shall constitute an irrevocable offer to sell such interest to the other Party as provided below. Unless the other Party notifies the Acquiring Party in writing that it does not desire to purchase such interest (a “ Notification of Non Interest ”) not more than ** after receipt of such notice from Acquiring Party, or the applicable Governmental Authority rejects the other Party as a buyer, then the Parties shall negotiate in good faith to reach an agreement within the ** period following the date of such notice with respect to the price to be paid by the other Party for such interest, and the sale of such interest shall be conditioned upon the consummation of such Business Combination Transaction. If (a) the other Party delivers a Notification of Non Interest during such ** period or (b) the Parties are unable to agree in writing on the price to be paid for such interest within such ** period and the other Party provides a Notification of Non Interest to the Acquiring Party within ** following the expiration of such ** period, then the Acquiring Party may sell its interest in the Collaboration to a Third Party without the consent or approval of the other Party; provided that (i) such Third Party shall expressly assume in a writing delivered to the other Party all of the rights and obligations of the Acquiring Party hereunder and (ii) the terms of sale shall be more favorable than those offered by the other Party to the Acquiring Party (unless no such offer has been made by the other Party); and the Acquiring Party shall have ** (or, if shorter, such period of time as may be required by the applicable Governmental Authority(ies) for such divestiture) to sell such interest; provided, that Adolor shall have the option to undertake Pfizer’s Development and/or Commercialization activities under the Collaboration during such ** period at Pfizer’s expense. If the other Party does not provide a Notification of Non Interest to the Acquiring Party within such ** period after such ** negotiation period or within ** after determination of the value of the Acquiring Party’s interest in the Collaboration, the other Party shall purchase the Acquiring Party’s interest in the Collaboration; and the price to be paid shall, **, and, subject to the consummation of the Business Combination Transaction, and except as set forth in Section 3.12(b)(iv) below, the Acquiring Party shall sell and convey to the other Party, and the other Party shall purchase, the Acquiring Party’s entire interest in the Collaboration at the price so determined:

(i) **.

(ii) **.

(iii) **.

(iv) Such determination shall be final and binding on both Parties.

(v) Except as provided in this Section 3.1.2(b), such determination shall be conducted in accordance with the procedures set forth in Section 17.5.

(vi) The closing of such purchase and sale of the Acquiring Party’s interest in the Collaboration pursuant to this Section 3.1.2(b) shall take place at a reasonable place and time designated by the Acquiring Party in writing on not less than ten (10) days’ prior written notice after the determination of the value of such interest and the price to be

 

25

 


paid, but not earlier than the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the receipt of all requisite approvals from Governmental Authorities, and, if the sale has been conditioned on the consummation of such Business Combination Transaction, such consummation having occurred. The Parties shall cooperate and shall promptly make such filings with and applications to such Governmental Authorities as may be required in connection with such purchase and sale.

(c) If the applicable Governmental Authority does not require the Acquiring Party, as a condition to such Business Combination Transaction, to divest either (i) such Acquired Competing Product or (ii) its interest in the Collaboration, then, if the Royalty Term is still in effect in the United States, Japan or a Major EU Country, the Acquiring Party shall notify the other Party in writing within ** after the consummation of such Business Combination Transaction of the acquisition of such Acquired Competing Product and whether it intends to (1) divest such Acquired Competing Product in the Countries where the Royalty Term is then in effect, (2) include the Acquired Competing Product as a Licensed Product under this Agreement in the Countries where the Royalty Term is then in effect; or (3) solely with respect to Pfizer, exercise its right of termination pursuant to Section 14.3. If the Acquiring Party notifies the other Party that it intends to divest such Acquired Competing Product, the Acquiring Party shall have ** following the consummation of the Business Combination Transaction to divest such Acquired Competing Product.

(d) If the Acquiring Party has notified the other Party in accordance with this Section 3.1.2 that an Acquired Competing Product will be divested, or the Acquiring Party will sell its interest in the Collaboration pursuant to subsection (b) hereof, the Development or commercialization of an Acquired Competing Product by the Acquiring Party during the period from the consummation of the applicable merger, consolidation or acquisition to the consummation of such divestiture or sale shall not be considered a breach by the Acquiring Party of its obligations under this Agreement; provided, however, that the Acquiring Party shall conduct any such Development or commercialization using personnel (i) distinct from personnel engaged in activities under this Agreement and (ii) who are not provided, directly or indirectly, or permitted to, access any Confidential Information relating to Named Compounds or Licensed Products.

3.2 Additional Named Compounds . In the event that, at any time during the Term, either Party or any of such Party’s Affiliates (as the case may be, the “ Developing Party ”) proposes to Develop an Unnamed Compound Controlled by such Party or Affiliate for indications other than a Named Indication, the other Party (the “ Offeree Party ”) shall have the options described below (collectively, the “ New Collaboration Compound Options ”) and the options described in Section 3.2.7 to include such compound (each, an “ Offered Compound ”) in the Collaboration, as set forth below. Any Unnamed Compound that is included in the Collaboration as the result of the exercise of any such option is referred to herein as a “ New Collaboration Compound .” Within thirty (30) days after the Offeree Party’s exercise of any New Collaboration Compound Option, such Party shall have the right to audit the Developing Party’s prior Development Costs relating to the Offered Compound, in a manner consistent with Section 7.15, provided, however, that any such audit shall not constitute the one (1) audit per Calendar

 

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Year permitted under Section 7.15. Neither Party shall have any obligation to Develop any Offered Compound unless a New Collaboration Compound Option is exercised with respect to such Offered Compound. Each New Collaboration Compound shall be Developed in accordance with this Agreement, including such New Collaboration Compound’s Development Plan. If the Offered Compound that a Party proposes to Develop for other than a Named Indication was obtained by the Developing Party by virtue of a Business Combination Transaction, such Offered Compound shall, upon the closing of such Business Combination Transaction, become subject to this Section 3.2.

3.2.1 **. If the Developing Party proposes to ** with respect to an Offered Compound, the Offeree Party shall have the option (the “**”), exercisable by written notice delivered to the Developing Party, to include such Offered Compound in the Collaboration, effective **, as provided below:

(a) Not less than ** with respect to such Offered Compound, the Developing Party shall prepare and provide to the Offeree Party (i) **, (ii) a statement of all of the Developing Party’s Out-of-Pocket Costs and Expenses attributable to the development of such Offered Compound (“ Option Costs ”), (iii) a representation letter making to the Offeree Party substantially the same representations and warranties concerning the Developing Party’s intellectual property relating to the Offered Compound as are set forth in Section 11.3 with respect to ADL 5859 and ADL 5747 (except that any reference to (x) the Effective Date shall refer to the date such representations and warranties are given and (y) to Adolor shall be deemed to refer to the Developing Party), along with any exceptions to such representations and warranties that such Party may disclose and provide in writing at such time, (iv) a proposed Development Plan for the Offered Compound (**), including a proposed budget therefore and (v) such other reasonably available information as the Offeree Party may reasonably request in connection with its evaluation of the option with respect to the Offered Compound provided for in this Section 3.2.1.

(b) At any time on or before the date which is ** after receipt of all the information specified in Section 3.2.1(a) the Offeree Party may exercise the ** with respect to such Offered Compound, and for such ** period the Developing Party shall be prohibited from entering into a Third Party Agreement pursuant to Section 3.2.8, by (i) delivering to the Developing Party written notice of such exercise and (ii) paying to the Developing Party ** the Developing Party’s Option Costs relating to the Offered Compound.

(c) If the Offeree Party exercises the **, then (i) the Offered Compound shall be a New Collaboration Compound thenceforth and shall be included in the Collaboration, and (ii) the Parties shall bear Development Costs, and shall share the Net Profit/Net Loss, with respect to the Licensed Products containing such New Collaboration Compound, in each case incurred on or after the Collaboration Inclusion Date, in the manner otherwise provided for in this Agreement.

3.2.2 **. If the Offeree Party does not exercise the ** with respect to an Offered Compound and provided that no Third Party Agreement has been entered into with respect to such Offered Compound pursuant to Section 3.2.8, the Offeree Party shall have an

 

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additional option (the “**”) to include any such Offered Compound in the Collaboration, commencing with the **, as provided below:

(a) Not less than ** prior to the commencement of ** with respect to the Offered Compound, the Developing Party shall provide to the Offeree Party (to the extent not previously provided) (i) the results of all ** with respect to such Offered Compound, (ii) a statement of the Developing Party’s Option Costs with respect to such Offered Compound, (iii) a representation letter making to the Offeree Party substantially the same representations and warranties concerning the Developing Party’s intellectual property relating to the Offered Compound as are set forth in Section 11.3 with respect to ADL 5859 and ADL 5747 (except that any reference to (x) the Effective Date shall refer to the date such representations and warranties are given; and (y) Adolor shall be deemed to refer to the Developing Party), along with any exceptions to such representations and warranties that such Party may disclose and provide in writing at such time, (iv) a Development Plan for the Offered Compound (including the details of the proposed **), including a proposed budget therefor, and (v) such other reasonably available information as the Offeree Party may reasonably request in connection with its evaluation of the option with respect to the Offered Compound provided for in this Section 3.2.2.

(b) At any time on or before the date which is ** after receipt of all the information specified in Section 3.2.2(a), the Offeree Party may exercise the ** with respect to such Offered Compound, and for such ** period the Developing Party shall be prohibited from entering into a Third Party Agreement pursuant to Section 3.2.8, by (i) delivering to the Developing Party written notice of such exercise and (ii) paying to the Developing Party ** times the Developing Party’s Option Costs up to the commencement of ** relating to the Offered Compound.

(c) If the Offeree Party exercises the **, then (i) the Offered Compound shall be a New Collaboration Compound thenceforth and shall be included in the Collaboration, and (ii) the Parties shall bear Development Costs, and shall share the Net Profit/Net Loss, with respect to the Licensed Products containing such New Collaboration Compound, in each case incurred on or after the Collaboration Inclusion Date, in the manner otherwise provided for in this Agreement.

3.2.3 **. If the Offeree Party does not exercise the ** with respect to an Offered Compound and provided that no Third Party Agreement has been entered into with respect to such Offered Compound pursuant to Section 3.2.8, the Offeree Party shall have an additional option (the “**”) to include any such Offered Compound in the Collaboration, commencing with **, as provided below:

(a) Not less than ** prior to the commencement of ** with respect to the Offered Compound, the Developing Party shall provide to the Offeree Party (to the extent not previously provided) (i) the results of all ** with respect to such Offered Compound, (ii) a statement of the Developing Party’s Option Costs with respect to such Offered Compound, (iii) a representation letter making to the Offeree Party substantially the same representations and warranties concerning the Developing Party’s intellectual property relating to the Offered

 

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Compound as are set forth in Section 11.3 with respect to ADL 5859 and ADL 5747 (except that any reference to (x) the Effective Date shall refer to the date such representations and warranties are given and (y) Adolor shall be deemed to refer to the Developing Party), along with any exceptions to such representations and warranties that such Party may disclose and provide in writing at such time, (iv) a Development Plan for the Offered Compound (including the details of the proposed **), including a proposed budget therefor, and (v) such other reasonably available information as the Offeree Party may reasonably request in connection with its evaluation of the option with respect to the Offered Compound provided for in this Section 3.2.3.

(b) At any time on or before the date which is ** after receipt of all the information specified in Section 3.2.3(a), the Offeree Party may exercise the ** with respect to such Offered Compound, and for such ** period the Developing Party shall be prohibited from entering into a Third Party Agreement pursuant to Section 3.2.8, by (i) delivering to the Developing Party written notice of such exercise and (ii) paying to the Developing Party ** times the Developing Party’s Option Costs up to the commencement of ** relating to the Offered Compound.

(c) If the Offeree Party exercises the **, (i) the Offered Compound shall be a New Collaboration Compound thenceforth and shall be included in the Collaboration, and (ii) the Parties shall bear Development Costs, and shall share the Net Profit/Net Loss, with respect to the Licensed Products containing such New Collaboration Compound, in each case incurred on or after the Collaboration Inclusion Date, in the manner otherwise provided for in this Agreement.

3.2.4 **. If the Offeree Party does not exercise the ** with respect to an Offered Compound and provided that no Third Party Agreement has been entered into with respect to such Offered Compound pursuant to Section 3.2.8, the Offeree Party shall have an additional option (the “**”) to include any such Offered Compound in the Collaboration effective upon ** with respect to such Offered Compound as provided below:

(a) Promptly following the completion of ** with respect to the Offered Compound and not less than ** prior to the filing of the ** with respect to the Offered Compound, the Developing Party shall provide to the Offeree Party (to the extent not previously provided) (i) the results of all ** with respect to such Offered Compound, (ii) a statement of the Developing Party’s Option Costs with respect to such Offered Compound, (iii) a representation letter making to the Offeree Party substantially the same representations and warranties concerning the Developing Party’s intellectual property relating to the Offered Compound as are set forth in Section 11.3 with respect to ADL 5859 and ADL 5747 (except that any reference to (x) the Effective Date shall refer to the date such representations and warranties are given and (y) Adolor shall be deemed to refer to the Developing Party), along with any exceptions to such representations and warranties that such Party may disclose and provide in writing at such time, (iv) a Development Plan for the Offered Compound (**), including a proposed budget therefor and a proposed ** for the Offered Compound, and (v) such other reasonably available information as the Offeree Party may reasonably request in

 

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connection with its evaluation of the option with respect to the Offered Compound provided for in this Section 3.2.4.

(b) At any time on or before the date which is ** after receipt of all the information specified by Section 3.2.4(a), the Offeree Party may exercise the ** with respect to such Offered Compound, and for such ** period the Developing Party shall be prohibited from entering into a Third Party Agreement pursuant to Section 3.2.8, by (i) delivering to the Developing Party written notice of such exercise and (ii) paying to the Developing Party (x) ** of the Developing Party’s Option Costs up to ** with respect to the Offered Compound; and (y) **.

(c) If the Offeree Party exercises the **, then (i) the Offered Compound shall be a New Collaboration Compound thenceforth and shall be included in the Collaboration, and (ii) the Parties shall bear Development Costs, and shall share the Net Profit/Net Loss, with respect to the Licensed Products containing such New Collaboration Compound, in each case incurred on or after the Collaboration Inclusion Date, in the manner otherwise provided for in this Agreement.

3.2.5 Commercialized Acquired Unnamed Compound Inclusion Option . In the event that an Acquiring Party effects a Business Combination Transaction with a Third Party that as of the date of the closing of such transaction would (a) have a Marketing Authorization Application filed and pending for, or have achieved Regulatory Approval for, a product containing an Unnamed Compound for other than a Named Indication in any Country in the Territory, or (b) be promoting, distributing, marketing or selling a product containing an Unnamed Compound for other than a Named Indication in any Country in the Territory (each such product referred to in clauses (a) and (b) above being referred to herein as a “ Commercialized Acquired Unnamed Compound ”), then the Acquiring Party shall offer the Commercialized Acquired Unnamed Compound into the Collaboration on written notice within ** after the consummation of such Business Combination Transaction of the acquisition of such Commercialized Acquired Unnamed Compound, and such Acquiring Party shall be considered the Developing Party and the Commercialized Acquired Unnamed Compound shall be an Offered Compound for purposes of this Section 3.2.5 and the Offeree Party shall have an option (the “ Commercialized Acquired Unnamed Compound Inclusion Option ”) to include such Commercialized Acquired Unnamed Compound in the Collaboration as provided below:

(a) Not later than ** after the delivery of the notice pursuant to this Section 3.2.5, the Developing Party shall provide to the Offeree Party (i) the results of all Clinical Studies relating to such Commercialized Acquired Unnamed Compound, (ii) a statement of the Developing Party’s Development costs with respect to any Phase 2 Clinical Studies or later Clinical Studies for the indications then being Commercialized or for which a Marketing Authorization Application has been filed, (iii) a representation letter making to the Offeree Party substantially the same representations and warranties concerning the Developing Party’s intellectual property relating to the Offered Compound as are set forth in Section 11.3 with respect to ADL 5859 and ADL 5747 (except that any reference to the Effective Date shall refer to the date such representations and warranties are given), along with any exceptions to such representations and warranties that such Party may disclose and provide in writing at such

 

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time, (iv) a Commercialization Plan for the Offered Compound, (v) a Calendar Quarter-by-Calendar Quarter statement of Net Sales, Development Costs, Marketing Expenses, Sales Expenses, and Net Profit/Net Loss (in each case calculated as if the Commercialized Acquired Unnamed Compound were a Licensed Product) of the Commercialized Acquired Unnamed Compound, (vi) a statement showing the aggregate cost of goods sold for such compound for each of the past four (4) Calendar Quarters, and (vii) such other information as the Offeree Party may reasonably request in connection with its evaluation of the option with respect to the Offered Compound provided for in this Section 3.2.5 above.

(b) At any time on or before the date which is ** after receipt of all the information specified in Section 3.2.5(a), the Offeree Party may deliver to the Developing Party a notice indicating that the Offeree Party is interested in including such Offered Compound in the Collaboration (an “ Indication of Interest ”), it being understood that such Indication of Interest does not constitute an exercise of the Commercialized Acquired Unnamed Compound Inclusion Option. If the Offeree Party delivers such Indication of Interest within such **, the Parties shall promptly commence negotiations in good faith for a period of not less than ** (or such longer period as the Parties may agree by mutual consent) concerning the terms on which such Offered Compound would be included in the Collaboration, which terms may include the amount of any upfront payments, terms relating to any indications then being Commercialized and terms relating to any indications that may still be in Development and any other matters the Parties deem relevant. If within such negotiation period the Parties agree by mutual consent to the terms on which the Offered Compound will be included in the Collaboration, such agreement shall constitute the exercise of the Commercialized Acquired Unnamed Compound Inclusion Option with respect to such Offered Compound. If the Offeree Party fails to deliver an Indication of Interest within the time period specified above or if the Parties fail to reach agreement on the terms on which the Offered Compound will be included in the Collaboration within the negotiation period provided for above, then such failure shall constitute the failure to exercise the Commercialized Acquired Unnamed Compound Inclusion Option and such Offered Compound shall be considered an Unnamed Compound.

(c) If the Offeree Party exercises the Commercialized Acquired Unnamed Compound Inclusion Option, then (i) the Offered Compound shall be a New Collaboration Compound thenceforth, (ii) products containing such Offered Compound shall be Licensed Products, (iii) unless the Parties have otherwise agreed by mutual consent on the terms on which the Offered Compound will be included in the Collaboration as provided in Section 3.2.5(b), the Parties shall each bear future Development Costs, if any, with respect to the Development, and the Net Profit/Net Loss, with respect to Licensed Products containing such New Collaboration Compound, in each case incurred after the Collaboration Inclusion Date, in the manner otherwise provided for, with respect to Named Compounds and Licensed Products pursuant to this Agreement, (iv) unless the Parties have otherwise agreed by mutual consent as provided in Section 3.2.5(b) above, the Offeree Party shall not be obligated to pay to the Developing Party any milestone payments with respect to such Named Compounds and Licensed Products, and (v) the Offeree Party shall pay to the Developing Party any agreed upfront or other payment agreed by the Parties.

 

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3.2.6 In-License Transactions . Other than pursuant to a Business Combination Transaction, neither Party shall, and each Party shall cause its Affiliates not to, in-license or acquire from a Third Party any Unnamed Compound being Developed for other than a Named Indication that is in Phase 1 Studies or later Clinical Studies if the terms of such in-license or acquisition would prevent such Unnamed Compound from being included in the Collaboration pursuant to this Section 3.2 on the terms provided for in this Agreement; provided that Section 3.1.1 shall apply to any Unnamed Compound under Development or being Commercialized for a Named Indication, whether or not such Unnamed Compound is acquired in a Business Combination Transaction.

3.2.7 Additional Option Periods . During the periods between (a) the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period; (b) the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period and (c) the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period, the Offeree Party shall have the right with respect to an Offered Compound to include such Offered Compound in the Collaboration; provided, that the Developing Party has not entered into a Third Party Agreement as provided for in Section 3.2.8, by (i) delivering to the Developing Party written notice to include such Offered Compound and (ii) paying to the Developing Party the greater of (x) the option price for the immediately preceding New Collaboration Compound Option and (y) the option price for the next succeeding New Collaboration Compound Option, as applicable; provided, that the option price shall be calculated with respect to the Option Costs incurred through the date of receipt of such notice, which amount the Developing Party shall provide to the Offeree Party within ten (10) days after receipt of the written notice from the Offeree Party described in this Section 3.2.7.

3.2.8 Third Party Agreement for Unnamed Compounds for Other Than Named Indications . During the periods (a) between the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period, (b) between the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period, (c) between the end of the exclusive ** exercise period and the beginning of the exclusive ** exercise period and (d) from the end of the exclusive ** exercise period and thereafter, in each case, as long as none of the New Collaboration Compound Options has been exercised with respect to such Offered Compound, the Developing Party shall have the right to enter into a license, collaboration or similar agreement with a Third Party with respect to such Offered Compound for any indication other than a Named Indication (at the time of execution of such agreement) (a “ Third Party Agreement ”; provided, however, that once the Developing Party enters into a Third Party Agreement and the Parties later add the indication that is the subject of such Third Party Agreement to Schedule 1.66 as a Named Indication, Section 3.1.1(a) shall not apply to activities under such Third Party Agreement for such Unnamed Compound for such indication provided that such indication was not a Named Indication at the time that such Third Party Agreement was entered into.

3.2.9 Failure to Exercise Option . If the Offeree Party fails to exercise all of the New Collaboration Compound Options with respect to an Offered Compound, the Developing Party shall have the right to Commercialize such Offered Compound solely for

 

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indications other than a Named Indication, outside the Collaboration and shall bear one hundred percent (100%) of the cost of such Development; provided that Section 3.1.1 shall continue to apply to the Offered Compound. For clarity, if any Unnamed Compound that was an Offered Compound for which the Offeree Party failed to exercise all of the New Collaboration Compound Options and such Offered Compound is Commercialized for an indication that is not a Named Indication at the time the first MAA is obtained with respect to such Unnamed Compound (a “ Marketed Unnamed Compound ”), Commercialization of such Unnamed Compound for such indication shall not constitute a breach of Section 3.1.1 as a result of the Parties’ subsequent agreement to add such indication to Schedule 1.66 as a Named Indication.

3.2.10 Consequences of Exercise of New Collaboration Compound Options . In the event the Offeree Party exercises a New Collaboration Compound Option with respect to a given Offered Compound, the Development Plan proposed by the Developing Party (or such other Development Plan as is agreed upon by the Parties on or prior to the date of the exercise of such option) with respect thereto pursuant to this Section 3.2 shall be the initial Development Plan with respect to such New Collaboration Compound and the New Collaboration Compound shall be added to Schedule 1.65 and if the Licensed Product is for an indication other than a Named Indication, such indication shall be added to Schedule 1.66 .

3.3 Additional Indications for Named Compounds; Unnamed Compounds for Named Indications .

3.3.1 Additional Proposal . Each Party may propose to Develop jointly as part of the Collaboration a Named Compound for an indication other than a Named Indication, or an Unnamed Compound for a Named Indication, by submitting a written proposal describing the proposed indication or Unnamed Compound, as applicable, which shall include a proposed Development Plan for Developing a product containing such Delta Compound for such proposed indication (an “ Additional Proposal ”) to the Joint Development Committee at any time during the Term. The non-proposing Party shall have sole discretion as to whether to accept such proposed indication as a Named Indication or such proposed Unnamed Compound as a Named Compound.

3.3.2 Acceptance of Unnamed Compound or Proposed Indication . If the non-proposing Party elects to accept the proposed indication as a Named Indication or proposed Unnamed Compound as a Named Compound, it shall give the proposing Party a notice of acceptance in writing within thirty (30) days after the Additional Proposal is submitted by the proposing Party, which acceptance shall become effective upon receipt. On and after such acceptance, such proposed indication shall be deemed a Named Indication and Schedule 1.66 shall be revised accordingly, or, as applicable, such proposed Unnamed Compound shall be deemed a Named Compound and Schedule 1.65 shall be revised accordingly. The proposed development plan shall be adopted by the Parties as the initial Development Plan for developing a Licensed Product for the proposed indication.

3.3.3 Rejection of Proposed Unnamed Compound or Indication . If the non-proposing Party fails to accept the proposed indication for a Named Compound as a Named Indication, or the proposed Unnamed Compound for a Named Indication as a Named

 

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Compound, in either case within thirty (30) days after the proposing Party’s submission of the Additional Proposal, then the provisions of Section 3.1.1 shall apply and, neither Party may, directly or indirectly, itself or through any Affiliate or Third Party, Develop or Commercialize either of the foregoing unless changes to Schedules 1.65 and/or 1.66 allow otherwise.

3.4 Removal of Named Compounds and Named Indications from the Collaboration . A Named Compound shall cease to be a Named Compound and shall be removed from the Named Compound list on Schedule 1.65 and a Named Indication shall cease to be a Named Indication and shall be removed from the Named Indication list on Schedule 1.66 pursuant to Section 5.2.2 or Section 6.14.

3.5 Screening Option . Subject to the rights, if any, granted to a Third Party to an Unnamed Compound pursuant to a Third Party Agreement entered into pursuant to Section 3.2.8, Pfizer shall have an option to screen additional Adolor Delta Compounds from Adolor’s Delta Compound library (the “ Screening Option ”). In the event that Pfizer exercises the Screening Option, the Parties shall negotiate in good faith the terms and conditions related to such screening. Such discovery and research collaboration may include Adolor granting to Pfizer or a Pfizer Affiliate a sublicense to the **.

ARTICLE 4 GOVERNANCE OF DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS

4.1 Joint Steering Committee .

4.1.1 Members; Officers . Within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “ Joint Steering Committee ” or “ JSC ”), which shall consist of six (6) members, three (3) of whom shall be designated by each of Pfizer and Adolor, who shall have appropriate expertise and seniority. Each of Pfizer and Adolor may replace any or all of its representatives on the Joint Steering Committee at any time upon written notice to the other Party. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designee at any meeting of the Joint Steering Committee. Pfizer and Adolor each may, on advance notice to the other Party, invite non-member employees of such Party to attend meetings of the Joint Steering Committee. The Joint Steering Committee shall be co-chaired by a representative of each of Pfizer and Adolor. One member of the JSC shall serve as secretary of the Joint Steering Committee at each Committee meeting, and the secretary shall alternate from meeting to meeting between a Pfizer Committee member and an Adolor Committee member.

4.1.2 Responsibilities . The Joint Steering Committee shall perform the following functions:

(a) Oversee all aspects of Collaboration pursuant to the terms of this Agreement;

(b) Review and approve the Development Plans for Licensed Products and any material amendments thereto;

 

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(c) To the extent the USCC has decision-making authority pursuant to Section 4.3.3, review and approve the Commercialization Plans for Licensed Products in the U.S. and any material amendments thereto;

(d) Oversee the integration of New Collaboration Compounds and new Named Indications into the Collaboration;

(e) Review and update Schedule 1.65 and Schedule 1.66 ;

(f) If, and only if, the Parties are sharing the Net Profit/Net Loss, at each meeting of the Joint Steering Committee, review Net Profit/Net Loss;

(g) Review the progress of the other Committees;

(h) Resolve disputes and other matters referred to the Joint Steering Committee by any other Committee; and

(i) Have such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

4.1.3 Meetings . The Joint Steering Committee shall meet in person at least once every six (6) months during every Calendar Year, and more or less frequently as Pfizer and Adolor mutually agree upon as appropriate or as required to resolve disputes, disagreements or deadlocks in the other Committees, or as reasonably requested by either such Party, on such dates, and at such places and times as the Parties shall agree; provided that the Parties shall endeavor to have the first meeting of the Joint Steering Committee within sixty (60) days after the Effective Date. Meetings of the Joint Steering Committee that are held in person shall alternate between offices of Pfizer and Adolor, or such other place as the Parties may agree. The members of the Joint Steering Committee also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence.

4.1.4 Decision-Making . The Joint Steering Committee may make decisions with respect to any subject matter that is subject to the Joint Steering Committee’s decision-making authority and functions as set forth in Section 4.1.2. All decisions of the Joint Steering Committee shall be made by unanimous vote or written consent, with Pfizer and Adolor each having, collectively, among its respective members, one (1) vote in all decisions. The Joint Steering Committee shall use commercially reasonable best efforts to resolve the matters within its roles and functions or otherwise referred to it. If the Joint Steering Committee cannot reach consensus on a matter within ten (10) Business Days after such matter has been brought to the Joint Steering Committee’s attention, then such matter shall be handled in the manner set forth below:

(a) Dispute Resolution . Any dispute that cannot be resolved by the JSC shall be first referred to the Alliance Managers. The Alliance Managers shall use their

 

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commercially reasonable best efforts to reach mutually acceptable resolutions on all such disputed matters. If the Alliance Managers are unable to resolve such dispute within ten (10) Business Days after the dispute is first referred to the Alliance Managers, the matter shall be referred on the eleventh (11 th ) Business Day to the Chief Executive Officer of Adolor and to Pfizer’s (i) Head of Worldwide Development for the applicable therapeutic area for issues originally referred to the JSC by the JDC and/or issues related to Development, or (ii) Head of the applicable U.S. Business Unit for issues originally referred to the JSC by the USCC and/or issues related to Commercialization for resolution (the “ Executives ”). In the event that


 
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