Exhibit 10.12

 

COLLABORATION AGREEMENT

 

by and between

 

IRONWOOD PHARMACEUTICALS, INC.

 

and

 

ASTRAZENECA AB

 

October 23, 2012

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

TABLE OF CONTENTS

 

1.

DEFINITIONS

2

 

 

 

2.

LICENSE GRANT

18

 

 

 

 

2.1.

License to AstraZeneca

18

 

2.2.

License to Ironwood

18

 

2.3.

Joint Technology and Development Data

19

 

2.4.

Rights of Reference

19

 

2.5.

Use of Third Party Contractors

20

 

2.6.

Sublicensing

20

 

2.7.

Section 365(n)

20

 

2.8.

No Other Rights

20

 

 

 

 

3.

DEVELOPMENT, REGULATORY, AND COMMERCIALIZATION

21

 

 

 

 

3.1.

Development

21

 

3.2.

Regulatory Matters

24

 

3.3.

Supply of Products

26

 

3.4.

Operations

27

 

3.5.

Commercialization in the Territory

29

 

3.6.

Other Committee Matters

33

 

3.7.

Executive Meetings

33

 

3.8.

Publication

34

 

3.9.

Compliance

34

 

 

 

 

4.

CONSIDERATION

35

 

 

 

 

 

4.1.

Upfront Payment

35

 

4.2.

Other Consideration

35

 

4.3.

Records and Audits

38

 

4.4.

Taxes and Withholding

39

 

4.5.

Currency

40

 

4.6.

Country of Payments

40

 

4.7.

Confidentiality

40

 

4.8.

Interest

40

 

 

 

 

5.

COVENANTS

41

 

 

 

 

 

5.1.

Confidentiality

41

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

5.2.

Restrictions

45

 

5.3.

[**]

45

 

5.4.

Compliance with Law

45

 

5.5.

Business Ethics

46

 

5.6.

Standstill Agreement

47

 

5.7.

Enforcement of Infringing or Counterfeit Goods

49

 

5.8.

Development Data

49

 

5.9.

Export Restrictions

50

 

5.10.

Existing Agreements

50

 

5.11.

Other Linaclotide Partners

50

 

5.12.

[**]

50

 

 

 

 

6.

REPRESENTATIONS AND WARRANTIES

50

 

 

 

 

 

6.1.

Representations and Warranties of Each Party

50

 

6.2.

Additional Representations, Warranties and Covenants of Ironwood

51

 

6.3.

Additional Representations and Warranties of AstraZeneca

54

 

6.4.

Representation by Legal Counsel

54

 

6.5.

No Inconsistent Agreements

55

 

6.6.

Disclaimer

55

 

 

 

 

7.

INTELLECTUAL PROPERTY

55

 

 

 

 

 

7.1.

Disclosure

55

 

7.2.

Ownership

55

 

7.3.

Intellectual Property Working Group

56

 

7.4.

Prosecution and Maintenance of Patent Rights

57

 

7.5.

Trademarks and Domain Names

58

 

7.6.

Enforcement and Defense of Technology Rights

60

 

7.7.

Third Party Claims

62

 

7.8.

Third Party Licenses

63

 

7.9.

Patent Marking

64

 

7.10.

Patent Certifications

64

 

7.11.

No Implied Licenses

64

 

7.12.

Privileged Communications

64

 

7.13.

Registration and Submission of the Agreement

65

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

8.

TERM AND TERMINATION

65

 

 

 

 

 

8.1.

Term

65

 

8.2.

Termination for Cause

65

 

8.3.

Termination for Convenience

66

 

8.4.

Change of Control

66

 

8.5.

Effects of Termination and Expiration

67

 

8.6.

Survival of Certain Obligations

70

 

 

 

 

9.

PRODUCT LIABILITY, INDEMNIFICATION, AND INSURANCE

71

 

 

 

 

 

9.1.

Sharing of Liability Expenses

71

 

9.2.

Indemnification by Ironwood

71

 

9.3.

Indemnification by AstraZeneca

72

 

9.4.

Procedure

73

 

9.5.

Insurance

73

 

9.6.

Liability Limitations

73

 

 

 

 

10.

MISCELLANEOUS

74

 

 

 

 

 

10.1.

Governing Law; Jurisdiction; Dispute Resolution

74

 

10.2.

Force Majeure

76

 

10.3.

Additional Approvals

77

 

10.4.

Waiver and Non-Exclusion of Remedies

77

 

10.5.

Notices

77

 

10.6.

Entire Agreement

78

 

10.7.

Language

79

 

10.8.

Amendment

79

 

10.9.

Assignment

79

 

10.10.

No Benefit to Others

80

 

10.11.

Counterparts

81

 

10.12.

Severability

81

 

10.13.

Further Assurance

81

 

10.14.

Publicity

81

 

10.15.

Certain Conventions

81

 

10.16.

Relationship of the Parties

82

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBITS

 

 

 

 

 

Exhibit A

 

Initial Development Plan

Exhibit B

 

Supply Agreement Terms and Related Matters

Exhibit C

 

Reconciliation Report Model

Exhibit D

 

Regulatory Cooperation

Exhibit E

 

Press Release

 

 

 

schedules

 

 

 

 

 

Schedule 1.104 [**]

 

Licensed Compound

Schedule 6.2(a)

 

Ironwood Patent Rights

Schedule 6.3

 

Certain Existing AZ In-Licensed Products

 

iv

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

COLLABORATION AGREEMENT

 

THIS COLLABORATION AGREEMENT (the “Agreement”) is entered into on this 23rd day
of October, 2012 (the “Effective Date”), by and among Ironwood
Pharmaceuticals, Inc., a corporation organized under the laws of Delaware
(“Ironwood”) and AstraZeneca AB, a corporation organized under the laws of
Sweden (“AstraZeneca”). Ironwood and AstraZeneca may be referred to in this
Agreement individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

A.                                    Ironwood is developing the Licensed
Compound (defined below) which has uses or potential uses in the treatment and
prevention of disease in humans.

 

B.                                    Ironwood (formerly Microbia, Inc.) has
entered into a Collaboration Agreement with Forest Laboratories, Inc.
(“Forest”), effective as of September 12, 2007, as amended from time to time
prior to the Effective Date or in accordance with this Agreement (the “Forest
Agreement”), under which Ironwood exclusively licensed to Forest certain rights
to the Licensed Compound in the Forest Territory (defined below) and Ironwood
and Forest agreed to collaborate on the development and commercialization of
such compound in the Forest Territory.

 

C.                                    Ironwood has entered into a License
Agreement with Almirall S.A. (formerly Laboratorios Almirall, S.A.) (“Almirall”)
effective as of April 30, 2009, as amended from time to time prior to the
Effective Date or in accordance with this Agreement (the “Almirall Agreement”),
under which Ironwood exclusively licensed to Almirall certain rights to the
Licensed Compound in the Almirall Territory (defined below) and Ironwood and
Almirall agreed to collaborate on the development and commercialization of such
compound in the Almirall Territory.

 

D.                                    Ironwood has entered into a License
Agreement with Astellas Pharma Inc. (“Astellas”) effective as of November 10,
2009, as amended from time to time prior to the Effective Date or in accordance
with this Agreement (the “Astellas Agreement”), under which Ironwood exclusively
licensed to Astellas certain rights to the Licensed Compound in the Astellas
Territory (defined below) and Ironwood and Astellas agreed to collaborate on the
development and commercialization of such compound in the Astellas Territory.

 

E.                                     AstraZeneca is engaged in the research,
development, manufacture and commercialization of human pharmaceutical products.

 

F.                                      Ironwood desires to grant to AstraZeneca
and AstraZeneca desires to receive an exclusive license to develop, market, and
distribute the Licensed Compound in China on the terms and conditions set forth
in this Agreement.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

AGREEMENT

 

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

 

1.                                      DEFINITIONS

 

For purposes of this Agreement, the following terms, when used in this
Agreement, have the meanings assigned to them in this Article 1.

 

1.1                               “Accounting Standards” means GAAP or IFRS, as
applicable.

 

1.2                               [**]

 

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

 

1.4                               “Agreement” is defined in the Introduction.

 

1.5                               “Almirall” is defined in Section C of the
Recitals.

 

1.6                               “Almirall Agreement” is defined in Section C
of the Recitals.

 

1.7                               “Almirall Territory” means the current and any
future member states of the European Union (consisting of the following
countries as of the Effective Date: Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United
Kingdom), Albania, Andorra, Georgia, Lichtenstein, Iceland, San Marino,
Switzerland, Turkey, Norway and Russia, as well as other countries of the former
Yugoslavia and those other countries forming the Commonwealth of Independent
States.

 

1.8                               [**]

 

1.9                               “Ancillary Agreements” means the Supply
Agreement, the Pharmacovigilance Agreement, and the Quality Assurance Agreement.

 

1.10                        “Anti-Corruption Laws” is defined in Section 5.5.1.

 

1.11                        “Applicable Law” means all applicable statutes,
ordinances, regulations, rules, or orders of any kind whatsoever of any
governmental authority or Regulatory Authority in

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

the Territory or otherwise having jurisdiction over any portion of the Parties’
activities under this Agreement, as amended from time to time.

 

1.12                        “Arbitrator” is defined in Section 10.1.3(a).

 

1.13                        “Astellas” is defined in Section D of the Recitals.

 

1.14                        “Astellas Agreement” is defined in Section D of the
Recitals.

 

1.15                        “Astellas Territory” means Japan, South Korea,
Taiwan, Thailand, Philippines, and Indonesia.

 

1.16                        “AstraZeneca” is defined in the Introduction.

 

1.17                        “AstraZeneca Collaboration Patent Rights” is defined
in Section 7.4.1.

 

1.18                        “AstraZeneca House Marks” means AstraZeneca’s and
its Affiliates’ trade names, corporate names and corporate logos.

 

1.19                        “AstraZeneca Indemnified Party” is defined in
Section 9.2.

 

1.20                        “AstraZeneca Know-How” means (a) Know-How that
AstraZeneca or its Affiliates Controls as of the Effective Date or that comes
into the Control of AstraZeneca or any of its Affiliates during the Term (other
than Collaboration Know-How, Joint Know-How and Development Data) that is
materially used in connection with or incorporated into the Licensed Compound or
Product by or on behalf of AstraZeneca or its Affiliates or Sublicensees, except
to the extent that any such Know-How relates to any active ingredient other than
a Licensed Compound, and (b) Collaboration Know-How (other than Joint Know-How
and Development Data) that is invented, conceived, or developed solely by
employees of AstraZeneca or its Affiliates, or Third Parties acting on behalf of
AstraZeneca or its Affiliates. Notwithstanding the foregoing, in no event shall
AstraZeneca Know-How include any Know-How relating to or arising out of
packaging or labeling activities of AstraZeneca.

 

1.21                        “AstraZeneca Patent Right” means any Patent Right
that is Controlled by AstraZeneca or any of its Affiliates as of the Effective
Date or comes into the Control of AstraZeneca or any of its Affiliates during
the Term and, in each case, claims AstraZeneca Know-How.

 

1.22                        “AstraZeneca Related Party” is defined in
Section 5.6.

 

1.23                        “AstraZeneca Technology” means AstraZeneca’s
interest in (a) the AstraZeneca Know-How, (b) the AstraZeneca Patent Rights and
(c) all other intellectual property rights in any of the foregoing.

 

1.24                        “Audited Party” is defined in Section 4.3.

 

1.25                        “Auditing Party” is defined in Section 4.3.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.26                        “Authorized Recipient” is defined in Section 5.1.1.

 

1.27                        “Authorized Representative” is defined in
Section 5.5.2.

 

1.28                        “Bankruptcy” is defined in Section 8.2.3.

 

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

 

1.30                        “CC” means chronic constipation.

 

1.31                        “Change of Control” means, with respect to a Person,
any of the following: (i) the sale or disposition of all or substantially all of
the assets of such Person to a Third Party, (ii) the acquisition by a Third
Party, other than an employee benefit plan (or related trust) sponsored or
maintained by such Person or any of its Affiliates, of more than 50% of such
Person’s outstanding shares of voting capital stock (e.g., capital stock
entitled to vote generally for the election of directors), (iii) the appointment
or election to the board of directors of such Person of members constituting a
majority of such board who were not appointed, approved or recommended for
election by the board of directors as constituted immediately prior to the
appointment or election of such majority, or (iv) the merger or consolidation of
such Person with or into another corporation, other than, in the case of (ii) or
(iv) above, an acquisition or a merger or consolidation of a Person in which
holders of shares of such Person’s voting capital stock immediately prior to the
acquisition, merger or consolidation have at least 50% of the ownership of
voting capital stock of the acquiring Third Party or the surviving corporation
in such merger or consolidation, as the case may be, immediately after the
merger or consolidation. Notwithstanding the foregoing, a Change of Control will
not be deemed to occur on account of a sale of assets, merger or other
transaction effected exclusively for the purpose of changing the corporate
domicile or legal form of such Person.

 

1.32                        “Claim” is defined in Section 10.1.3(a).

 

1.33                        “Clinical Trial Material” means the Licensed
Compound in finished dosage form that is used in clinical trials, but not for
Commercial sale.

 

1.34                        “Collaboration Know-How” means Know-How that is
invented, conceived, or developed by or on behalf of either Party’s or both
Parties’ (or their Affiliates’) employees or Third Parties acting on such
Party’s or Parties’ (or their Affiliates’) behalf, in each case in the course of
such Party’s or Parties’ (or their Affiliates’) performance under this Agreement
or any Ancillary Agreement.

 

1.35                        “Collaboration Patent Rights” means Patent Rights
claiming Collaboration Know-How.

 

1.36                        “Collaboration Technology” means Collaboration
Know-How and Collaboration Patent Rights, and all other intellectual property
rights in any of the foregoing.

 

1.37                        “Combination” is defined in Section 5.6.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.38                        “Combination Product” means a Product that contains
the Licensed Compound in combination with one or more other products or active
ingredients, the manufacture, use or sale of which are not covered by a Patent
Right Controlled by Ironwood.

 

1.39                        “Commercialization” means any and all activities of
importing, marketing, promoting, distributing, offering for sale, or selling a
Product in the Territory, including for example pre-First Commercial Sale market
development activities conducted in anticipation of Regulatory Approval of
Product, seeking pricing reimbursement approvals for Product, if applicable,
preparing advertising and promotional materials and sales force training.
Commercialization does not include Development or Manufacturing. When used as a
verb, “Commercialize” means to engage in Commercialization.

 

1.40                        “Commercialization Budget” means the budget adopted
in accordance with Section 3.5.1 for conducting Commercialization activities
pursuant to the Commercialization Plan.

 

1.41                        “Commercialization Expenses” means all
fully-burdened internal and external costs and expenses (except as otherwise
expressly provided in the Commercialization Budget, which provision explicitly
acknowledges a deviation from this Section 1.41) (a) associated with
Commercialization activities relating to the Commercialization of the Product
pursuant to the Commercialization Plan, in each case as set forth in the
Commercialization Plan and Commercialization Budget (or constituting a permitted
overage thereto under Section 4.2.6), including Selling Expenses, Marketing
Expenses, Managed Care Expenses, and all irrevocable, Indirect Taxes and duties,
or (b) approved by the JCC as Commercialization Expenses prior to the date on
which the Initial Commercialization Plan and the initial Commercialization
Budget are approved by the JCC. For clarity, any import duties or
non-recoverable VAT incurred due to shipping the Product into the Territory for
Commercialization purposes shall be considered a Commercialization Expense.
Notwithstanding the foregoing, Commercialization Expenses will not include [**].

 

1.42                        “Commercialization Plan” means the strategic
commercialization plan for the Product in the Field in the Territory, as such
plan may be amended or updated from time to time in accordance with this
Agreement. The Commercialization Plan will include, but is not limited to, (a) a
multi-year marketing strategy, (b) a multi-year communications strategy that
includes plans for public relations, conferences and exhibitions and other
external meetings, internal meetings and communications, publications and
symposia, internet activities and core brand package, (c) a high level operating
plan for the implementation of such strategies on an annual basis, including
information related to product positioning, core messages to be communicated,
share of voice requirements and pricing strategies, (d) a multi-year Detailing
strategy, including a call plan consisting of a high-level geographic
distribution of Details, a targeted range of the aggregate number of Details to
be performed and the position of such Details (e.g., primary or secondary), and
(e) all other material activities to be conducted in connection with the
Commercialization of the Product in the Field in the Territory.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.43                        “Commercially Reasonable Efforts” means those
efforts and resources normally used by [**], taking into account, without
limitation, issues of safety and efficacy, product profile, the proprietary
position of the product or compound, the regulatory environment and status of
the compound, and other relevant scientific factors, market conditions then
prevailing, as well as profitability, the extent of market exclusivity, the cost
to develop the compound or product, health economic claims, and other similar
factors reasonably determined by [**] to be relevant. “Commercially Reasonable”
as used in this Agreement will be interpreted in a corresponding manner.

 

1.44                        “Confidential Information” means, subject to
Sections 5.1.2 and 5.1.3, any and all data, results, Know-How (including the
Ironwood Know-How and AstraZeneca Know-How) and business information, whether
oral or in writing or in any other form, disclosed before, on or after the date
of this Agreement by one Party to the other Party under this Agreement or any
Ancillary Agreement or prior to the Effective Date. Any information disclosed at
a meeting of the JDC, JOC or JCC will constitute Confidential Information unless
otherwise specified.

 

1.45                        “Control” or “Controlled” means, with respect to any
intellectual property right or Know-How of a Party or any of its Affiliates or,
as applicable, Future Acquirer, that the Party or its Affiliates or, as
applicable, a Future Acquirer (a) owns, has an interest in, or, other than
pursuant to this Agreement, has a license to such intellectual property right or
Know-How and (b) has the ability to grant access, a license or a sublicense to
such intellectual property right or Know-How to the other Party as provided in
this Agreement without violating an agreement with or other rights of any Third
Party, provided, however, that (i) any intellectual property right or Know-How
of a Party or any of its Affiliates, which intellectual property right or
Know-How is acquired after the Effective Date, may be excluded from the scope of
the intellectual property rights and Know-How Controlled by such Party by
written notice to the other Party if (A) the exercise of such intellectual
property or use of such Know-How by the other Party would trigger a royalty or
other payment to a Third Party, (B) such intellectual property right or Know-How
is not the subject of a license entered into pursuant to Section 7.8 and
(C) following notification of the other Party by such Party, the other Party
[**] and (ii) any intellectual property right or Know-How Controlled by a Future
Acquirer of Ironwood will be excluded from intellectual property Controlled by
Ironwood for purposes of this Agreement except to the extent that such
intellectual property right or Know-How is (A) developed, acquired or otherwise
Controlled pursuant to or in connection with a license or other agreement with
Ironwood, whether owned by Ironwood or such Future Acquirer (for purposes of
this definition, such intellectual property rights and Know-How, the “Related
IP”) as of the effective date of the applicable Change of Control of Ironwood,
(B) developed or acquired by such Future Acquirer following such Change of
Control with the use of the Ironwood Know-How or any Related IP or (C) used in
the development, manufacture or commercialization of the Licensed Compound or
Product by the Future Acquirer.

 

1.46                        “Counterfeiting” is defined in Section 5.7.

 

1.47                        “CRO” means a qualified clinical research
organization.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.48                        [**]

 

1.49                        “Detail” means a face-to-face meeting, in an
individual or group practice setting, between one or more physician prescribers
and one or more AstraZeneca or Ironwood (if Ironwood exercises its rights under
Section 3.5.4) sales representatives during which product information is
communicated in a manner consistent with the Commercialization Plan and this
Agreement. When used as a verb, “Detail” or “Detailing” will mean to engage in a
Detail.

 

1.50                        “Detail Rate” as applicable to both Parties, means
the Detail rate set forth in the Commercialization Plan, as amended from time to
time. For purposes of applying the Detail Rate, each Detail will be weighted as
set forth in the Commercialization Plan. The Commercialization Plan shall
specify what costs are intended to be covered by the Detail Rate.

 

1.51                        “Development” means all activities performed by or
on behalf of either Party in the performance of the Development Plan.
Development will include all activities related to research (including
Post-Approval Research), non-clinical testing, test method development and
stability testing, toxicology, formulation, process development, manufacturing
scale-up, quality assurance/quality control, clinical studies including Phase
II, Phase III and pricing studies, medical-scientific affairs, scientific
publications, obtaining, maintaining or expanding Regulatory Approval and
otherwise handling regulatory affairs, statistical analysis and report writing
performed pursuant to the Development Plan with respect to the Product.
Development will not include Manufacturing or Commercialization. When used as a
verb, “Develop” means to engage in Development.

 

1.52                        “Development Budget” means the budget adopted in
accordance with Section 3.1.1 for conducting Development activities pursuant to
the Development Plan.

 

1.53                        “Development Data” means any (a) pharmacology,
toxicology and other biological data included in the Collaboration Technology
that was created to support a Regulatory Submission in the Territory and
(b) clinical data included in the Collaboration Technology.

 

1.54                        “Development Expense” means the fully-burdened
internal and external costs (except as otherwise expressly provided in the
Development Budget, which provision explicitly acknowledges a deviation from
this Section 1.54) incurred by a Party in connection with studies or activities
performed pursuant to the Development Plan in order to obtain, maintain or
expand the relevant Regulatory Approval to Manufacture, use or sell Product in
the Field in the Territory to the extent included in the Development Budget.
Development Expense will include, in each case to the extent relating to the
Development of the Product and set forth in the Development Plan and Development
Budget (or constituting a permitted overage thereto under Section 4.2.6),
(a) all out-of-pocket costs and expenses actually incurred by AstraZeneca or
Ironwood in conducting such studies or activities including without limitation
costs of studies on the toxicological, pharmacological, metabolic or clinical
aspects of the Licensed Compound or Product

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

conducted internally or by individual investigators or consultants and necessary
for the purpose of obtaining, maintaining or expanding Regulatory Approval of
the Product, including Post-Approval Research, process development, process
improvement and scale-up costs (including validation, qualification lots,
technology transfer and analytical transfer for supply of Licensed Compound or
Product to AstraZeneca), [**], (b) the costs of internal personnel engaged in
the performance of such studies or activities, including the activities
described below in this Section 1.54 (such costs will be included in the
Development Budget [**]), (c) all costs of developing data for Regulatory
Submissions and all costs associated with making such submissions, (d) all costs
related to pharmacovigilance activities (unless included in Commercialization
Expenses), (e) all costs of Clinical Trial Materials, (f) all
irrevocable, Indirect Taxes and duties, and (g) any other costs that are
designated as Development Expenses herein. For clarity, any import duties or
non-recoverable VAT incurred due to shipping the Product into the Territory for
Development purposes shall be considered a Development Expense. Notwithstanding
any other provision of this Agreement to the contrary, [**].

 

1.55                        “Development Plan” means the plan for the
development of the Licensed Compound for Regulatory Approval and Post-Approval
Research in the Territory, including (a) a multi-year strategy for Phase IV
studies and lifecycle management activities, if any, (b) success criteria for
any clinical trials included in such Development Plan, (c) a strategy for
obtaining, maintaining and, if applicable, expanding Regulatory Approvals for
the Product, including an allocation of responsibilities for implementing such
strategy and (d) an expected timetable for the completion of such clinical
trials, as such plan may be amended or updated from time to time in accordance
with this Agreement.

 

1.56                        “Disclosing Party” is defined in Section 5.1.1.

 

1.57                        “Dyspepsia” means functional dyspepsia, postprandial
distress syndrome, epigastric pain syndrome, ulcer-like dyspepsia,
dysmotility-like dyspepsia and unspecified dyspepsia.

 

1.58                        “Effective Date” is defined in the Introduction.

 

1.59                        [**]

 

1.60                        “Existing Agreements” means the Forest Agreement,
the Almirall Agreement and the Astellas Agreement.

 

1.61                        “Fair Market Value” means with respect to a
valuation required by any provision of this Agreement, (a) [**], if such
valuation must be determined [**], or (b) if clause (a) does not apply, [**].
Fair Market Value will be determined by [**].

 

1.62                        “Field” means all human prophylactic and therapeutic
uses of a Product in all Oral Forms for any and all indications, including but
not limited to IBS-C, CC, OIC, IBS-A, Dyspepsia and other lower gastrointestinal
disorders.

 

8

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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

 

1.64                        “Force Majeure” is defined in Section 10.2.

 

1.65                        “Forest” is defined in Section B of the Recitals.

 

1.66                        “Forest Agreement” is defined in Section B of the
Recitals.

 

1.67                        “Forest Territory” means the countries of North
America, consisting of the United States, Canada, and Mexico, and their
respective territories and possessions (including Puerto Rico, irrespective of
political status).

 

1.68                        “FTE Rate” means the [**] per employee [**]. The FTE
Rates will initially be [**] provided however that such rates may be adjusted
from time to time by the JDC, JOC, or JCC, as applicable, and such updated rate
will be set forth in the Development Plan or Commercialization Plan, as
applicable. The FTE Rate for a full-time equivalent for a Calendar Quarter shall
equal 25% of the foregoing annual rate.  For purposes of determining the FTE
Rate, [**].

 

1.69                        “Future Acquirer” means the Third Party to any
Change of Control transaction and such Third Party’s Affiliates immediately
prior to the Change of Control.

 

1.70                        “GAAP” means United States generally accepted
accounting principles, as in effect from time to time.

 

1.71                        “GC-C Agonist” means a guanylate cyclase C agonist.

 

1.72                        “GI Effect” means all human prophylactic and
therapeutic uses for gastrointestinal indications.

 

1.73                        “Good Clinical Practice” or “GCP” means the
standards of good clinical practice as are required by governmental agencies in
countries in which the Products are intended to be sold under this Agreement.

 

1.74                        “Group” is defined in Section 5.6.

 

1.75                        “IBS-A” means irritable bowel syndrome with
alternating bowel habits.

 

1.76                        “IBS-C” means irritable bowel syndrome with the
primary manifestation of constipation.

 

1.77                        “ICC” is defined in Section 10.1.3(a).

 

1.78                        “IFRS” means the International Financial Reporting
Standards, as in effect from time to time.

 

9

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.79                        “Impairment” means that (a) it is reasonably
anticipated that the entity resulting from a Change of Control of AstraZeneca,
Parent or any Local Affiliate will be unable to perform its obligations in
accordance with the terms of this Agreement, as reasonably determined based on
objective criteria available to both Parties, including the new entity’s
financial position and product pipeline, (b) the acquiring entity in such Change
of Control or any of its Affiliates (prior to the Change of Control) is actively
developing or commercializing a GC-C Agonist indicated for the treatment of
IBS-C, CC, or OIC (unless as to any such indication, the JDC has determined not
to pursue Development for such indication) or any other indication for which the
Product is then being Developed or Commercialized in the Territory pursuant to
this Agreement, unless such entity or such Affiliate ceases such activity or
[**].

 

1.80                        “Indemnified Party” is defined in Section 9.4.

 

1.81                        “Indemnifying Party” is defined in Section 9.4.

 

1.82                        “Indirect Taxes” means VAT, sales taxes, consumption
taxes and other similar taxes required by law to be disclosed on a Tax Invoice.

 

1.83                        “Infringement” is defined in Section 7.6.2.

 

1.84                        “Initial Commercialization Plan” is defined in
Section 3.5.1(g).

 

1.85                        “Initial Development Plan” is defined in
Section 3.1.2.

 

1.86                        “IPWG” is defined in Section 7.3.

 

1.87                        “Ironwood” is defined in the Introduction.

 

1.88                        “Ironwood House Marks” means Ironwood’s and its
Affiliates’ trade names, corporate names and corporate logos.

 

1.89                        “Ironwood Indemnified Party” is defined in
Section 9.3.

 

1.90                        “Ironwood Know-How” means (a) Know-How that Ironwood
or any of its Affiliates Control as of the Effective Date, including Know-How
that has arisen or arises under the Existing Agreements to the extent Controlled
by Ironwood or its Affiliates, or that comes into the Control of Ironwood or its
Affiliates during the Term (other than Joint Know-How and Development Data) to
the extent necessary or useful in the Territory to Develop or Commercialize the
Licensed Compound or Product, including without limitation any method of making
the Licensed Compound or Product, any composition or formulation of the Licensed
Compound or Product, or any method of using or administering the Licensed
Compound or Product, except to the extent that any such Know-How relates solely
to any active ingredient in a Product other than the Licensed Compound, and
(b) Collaboration Know-How (other than Joint Know-How and Development Data) that
is invented, conceived or developed by one or more of the following: employees
of Ironwood or its Affiliates, or Third Parties acting on behalf of Ironwood or
its Affiliates.

 

10

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.91                        “Ironwood Patent Rights” means (a) any Patent Rights
claiming Ironwood Know-How, and (b) any other Patent Rights that Ironwood or any
of its Affiliates Control as of the Effective Date, including Patent Rights
under the Existing Agreements, or that come into the Control of Ironwood or its
Affiliates during the Term (other than Joint Patent Rights) to the extent such
rights cover or recite the Licensed Compound or Product, any method of making
the Licensed Compound or Product, any composition or formulation of the Licensed
Compound or Product in the Territory or any method of using or administering any
Licensed Compound or Product, except to the extent that any such Patent Rights
relate solely to any active ingredient in a Product other than the Licensed
Compound.

 

1.92                        “Ironwood Technology” means Ironwood’s and its
Affiliate’s interest in (a) the Ironwood Know-How, (b) the Ironwood Patent
Rights, and (c) all other intellectual property rights in any of the foregoing.

 

1.93                        “JCC” is defined in Section 3.5.1(a).

 

1.94                        “JCC Deadlock” is defined in Section 3.5.1(f).

 

1.95                        “JDC” is defined in Section 3.1.1(a).

 

1.96                        “JDC Deadlock” is defined in Section 3.1.1(f).

 

1.97                        “JOC” is defined in Section 3.4.1(a).

 

1.98                        “JOC Deadlock” is defined in Section 3.4.1(f).

 

1.99                        “Joint Know-How” means any Collaboration Know-How,
other than Development Data, that is invented, conceived or developed jointly by
one or more employees of Ironwood or its Affiliates (or any Third Party or Third
Parties acting on any of their behalf) and one or more employees of AstraZeneca
or its Affiliates (or any Third Party or Third Parties acting on any of their
behalf).

 

1.100                 “Joint Patent Right” means any Patent Right that claims
Joint Know-How and names as the inventors one or more employees or agents of
Ironwood or its Affiliates together with one or more employees or agents of
AstraZeneca or its Affiliates, as determined by U.S. law.

 

1.101                 “Joint Technology” means Joint Know-How, Joint Patent
Rights, and all other intellectual property rights therein.

 

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

 

11

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.103                 “Liabilities” is defined in Section 9.1.

 

1.104                 “Licensed Compound” means Ironwood’s proprietary GC-C
Agonist generally referred to as “linaclotide” and having the chemical structure
set forth on Schedule 1.104 and any salts, metabolites, polymorphs and pro-drugs
thereof.

 

1.105                 “Local Affiliate” means any of AstraZeneca’s Affiliates
that are responsible for Developing or Commercializing the Product in the
Territory.

 

1.106                 “Managed Care Expenses” means the costs and expenses of
activities related to obtaining reimbursement from payers, work on managed care
accounts and other similar activities directly related to the Commercialization
of Products in the Territory.

 

1.107                 “Manufacture,” “Manufactured” or “Manufacturing” means all
activities involved in the production, storing, handling, packaging, and
labeling of any Licensed Compound or Product to be Developed or Commercialized
under this Agreement.

 

1.108                 “Marketing Expenses” means the costs and expenses
associated with marketing the Product in the Territory, including costs for
preparing and reproducing Detailing aids, Product promotional materials and
other promotional materials, costs of professional education, Product-related
public relations, relationships with opinion leaders and professional societies,
market research, costs of sales and marketing data and other similar activities
directly related to the Commercialization of Products in the Territory.

 

1.109                 [**]

 

1.110                 “Milestone Event” is defined in Section 4.2.1.

 

1.111                 “Monetization Transaction” is defined in Section 10.9.

 

1.112                 “Net Loss” means, for a given period, Net Sales in the
Territory less Program Expenses incurred in connection with the Development and
Commercialization of the Product in the Territory, where the result is a
negative number.

 

1.113                 “Net Profit” means, for a given period, Net Sales in the
Territory less Program Expenses incurred in connection with the Development and
Commercialization of the Product in the Territory, where the result is a
positive number.

 

1.114                 “Net Sales” means, with respect to any period, the gross
amounts invoiced by AstraZeneca, its Affiliates or Sublicensees, as applicable,
to Third Parties for sales of the Product in the Field in the Territory, less
the following deductions to the extent included in the gross invoiced sales
price for the Product or otherwise directly paid or incurred by AstraZeneca, its
Affiliates or Sublicensees, with respect to the sale of the Product in the
Territory: (i) trade, quantity or cash discounts credits, adjustments or
allowances, including those granted on account of price adjustments, billing
errors, rejected goods, or damaged goods; (ii) rebates and chargebacks allowed,
given or accrued (including, but not limited to, cash, governmental and managed
care rebates, hospital or other buying group chargebacks, and governmental taxes
in the nature of a rebate based on usage

 

12

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

levels or sales of the Product); (iii) sales, excise, turnover, inventory, and
similar taxes (not offset or refunded, except in the case of value added taxes)
assessed on the sale of the Product; (iv) bad debts reserved for on the basis
utilized by AstraZeneca in its branded pharmaceutical business generally or, if
greater, bad debts actually written off, in each case which are attributable to
sales of Product; (v) administrative fees paid to group purchasing organization,
managed care entities or other similar types of organizations or networks
participating in the distribution and/or sales of the Product; (vi) amounts paid
or credited to customers for inventory management services; (vii) any other
similar and customary deductions that are consistent with GAAP or IFRS, if
applicable; and (viii) an allowance for transportation costs, distribution
expenses, special packaging and related insurance charges, freight and insurance
charges, taken in accordance with AstraZeneca’s standard practices applicable to
other of AstraZeneca’s products, which allowance will in no event exceed [**] of
the amount arrived at after application of items (i) to (vii) above. Net Sales
will be determined in accordance with applicable Accounting Standards. Without
limiting the generality of the foregoing, sales, transfers, or dispositions of
Product for charitable, promotional (including samples), non-clinical, clinical,
or regulatory purposes will be excluded from Net Sales, as will sales or
transfers of Product among a Party and its Affiliates or Sublicensees.

 

Net Sales of Combination Products will be calculated by first determining Net
Sales of such Combination Product (in its entirety) pursuant to the foregoing
and then multiplying the Net Sales of the Combination Product by the fraction
A/(A+B), where A is the gross invoice price of the Licensed Compound if sold
separately as a single agent Product in the Territory and B is the gross invoice
price of the other active ingredient(s) sold as single agent product(s) included
in the Combination Product if sold separately in the Territory. In the event no
such separate sales are made by AstraZeneca, its Affiliates or Sublicensees, in
the Territory, Net Sales of the Combination Product will be calculated by
multiplying such Net Sales by a fraction fairly and reasonably reflecting the
relative value contributed by the Licensed Compound or Product to the total
value of the Combination Product as determined by the Parties in good faith.

 

1.115                 “New Drug Application” or “NDA” means a new drug
application filed with a Regulatory Authority (not including pricing and
reimbursement approval), that is analogous to the new drug application with the
United States Food and Drug Administration described in 21 C.F.R. § 314.

 

1.116                 “Official” is defined in Section 5.5.2.

 

1.117                 “OIC” means opioid induced constipation.

 

1.118                 “Oral Form” means a finished dosage form that is delivered
to the gastrointestinal tract after delivery through the mouth, in any dosage
strength or form. Specifically, an Oral Form includes forms that dissolve in the
mouth but not forms that are delivered by injection or inhalation.

 

1.119                 “Order” is defined in Section 5.1.3.

 

13

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.120                 [**]

 

1.121                 “Other Out-of-Pocket Costs” means the (a) costs incurred
in connection with [**], (b) costs incurred in [**], (c) costs incurred in [**],
and (d) such other costs as are designated as Other Out-of-Pocket Costs herein
or otherwise mutually agreed upon by the Parties. All costs included in the
foregoing will be fully burdened internal and external costs except as otherwise
agreed by the Parties in writing.

 

1.122                 “Parent” is defined in Section 8.4.2.

 

1.123                 “Party” and “Parties” is defined in the Introduction.

 

1.124                 “Patent Rights” means any and all (a) U.S. or foreign
patent applications, including all provisional applications, substitutions,
continuations, continuations-in-part, divisions, renewals, and all patents
granted thereon, (b) all U.S. or foreign patents, reissues, reexaminations and
extensions or restorations by existing or future extension or restoration
mechanisms, including supplementary protection certificates or the equivalent
thereof, and (c) any other form of government-issued right substantially similar
to any of the foregoing.

 

1.125                 “Payments” is defined in Section 4.4.1.

 

1.126                 “Person” means any individual, corporation, company,
limited liability company, partnership, limited liability partnership, trust,
estate, proprietorship, joint venture, association, organization, or entity.

 

1.127                 “Pharmacovigilance Agreement” is defined in Section 3.2.4.

 

1.128                 “Phase II” in reference to a clinical trial means a trial
defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any
foreign equivalent thereto.

 

1.129                 “Phase III” in reference to a clinical trial means a trial
defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any
foreign equivalent thereto.

 

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

 

1.131                 “Post-Approval Research” means ongoing research and
development of a Product after such Product has received Regulatory Approval in
the Territory, including Phase IV clinical studies and clinical studies in
support of indications within the Field or labeling changes for such Product
within the Field in the Territory during the Term.

 

1.132                 “Procurement Costs” means any costs or expenses of
AstraZeneca or its Affiliates incurred in its capacity as purchaser of Product
for sale in the Territory under the Supply Agreement that are not reimbursed
under the Supply Agreement, including any [**], but excluding (a) [**] and
(b) [**].

 

14

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.133                 “Product” means any pharmaceutical product in finished
form that contains the Licensed Compound either as the sole active ingredient or
in a Combination Product, in any present or future Oral Forms. For the avoidance
of doubt, “Product” excludes non-Oral Forms, including intravenous and inhalable
forms.

 

1.134                 “Product Domain Name” is defined in Section 7.5.1.

 

1.135                 “Product Liability Claims” is defined in Section 9.1.

 

1.136                 “Product Trademarks” is defined in Section 7.5.1.

 

1.137                 “Program Expenses” means the Development Expenses,
Commercialization Expenses, Supply Costs, Procurement Costs, and Other
Out-of-Pocket Costs.  Any category of Program Expenses is intended to include
those costs and expenses incurred by either a Party or its Affiliates in
accordance with this Agreement.

 

1.138                 “Prohibited Payment” is defined in Section 5.5.2.

 

1.139                 “Quality Assurance Agreement” is defined in Section 3.4.2.

 

1.140                 “Receiving Party” is defined in Section 5.1.1.

 

1.141                 “Reconciliation Report” is defined in Section 4.2.5.

 

1.142                 “Referenced Regulatory Filings” means all Regulatory
Submissions Controlled by Ironwood or any of its Affiliates on the Effective
Date and during the Term, including Regulatory Submissions to which Ironwood
receives a transferable Right of Reference from other licensees of the Licensed
Compound or Product, that are necessary or useful to Manufacture the Licensed
Compound or Product anywhere in the world or Develop or Commercialize the
Licensed Compound or Product in the Field in the Territory.

 

1.143                 “Regulatory Approval” means the approval and authorization
of a Regulatory Authority in a country necessary to develop, manufacture,
distribute, sell, or market a Product in that country, including pricing and
reimbursement approval.

 

1.144                 “Regulatory Authority” means any government regulatory
authority involved in granting approvals for the development, manufacturing,
distribution, marketing, reimbursement or pricing of a Product.

 

1.145                 “Regulatory Submission” means any application for
Regulatory Approval, notification, and other submission made to or with a
Regulatory Authority that is necessary or reasonably desirable to develop,
manufacture, distribute or commercialize the Product in the Field in a
particular country, whether obtained before or after a Regulatory Approval in
the country. Regulatory Submissions include, without limitation, investigational
new drug applications, clinical trial applications and NDAs or imported drug
license (IDL) applications, and amendments, renewals and supplements to any of
the foregoing and their foreign counterparts, applications for pricing and
reimbursement

 

15

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

approvals, and all proposed labels, labeling, package inserts, monographs, and
packaging for the Product.

 

1.146                 “Reimbursement Drug List” means the Medicine Catalog for
the National Basic Medical Insurance, Industrial Injury Insurance and Maternity
Insurance issued by the Ministry of Human Resource and Social Security, and any
revisions or reissuances thereof from time to time, in China.

 

1.147                 “Responsible Party” means, with respect to any activity to
be performed by a Party in connection with the obtaining, maintaining or
expanding of a Regulatory Approval in the Territory, the Party identified in the
Development Plan or designated by the JDC as the Party responsible for
conducting such activity. In the absence of such a designation, [**] is
considered the Responsible Party.

 

1.148                 “Revenue Buyer” is defined in Section 10.9.

 

1.149                 “Right of Reference” is defined in Section 2.4.

 

1.150                 “Safety Panel” means a panel of [**]. In the event the
Parties are required to select a Safety Panel, each Party will [**]. Each Party
will [**]. The decision of [**] will be deemed the decision of the Safety Panel.
The Parties will instruct the Safety Panel to reach its decision as promptly as
practicable, but within [**]. The costs of any Safety Panel will be [**].

 

1.151                 “Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002,
and the rules and regulations promulgated thereunder.

 

1.152                 “Selling Expenses” means for Detailing, the applicable
Detail Rate multiplied by the number of Details weighted in accordance with the
Commercialization Plan and other selling costs and expenses not included in the
Detail Rate, including [**].

 

1.153                 “Shared Liability Claims” is defined in Section 9.1.

 

1.154                 “Subject Technology” is defined in Section 7.6.5.

 

1.155                 “Sublicense” means an agreement or arrangement pursuant to
which a sublicense or distribution right has been granted.

 

1.156                 “Sublicensee” means a Third Party that is granted a
license, sublicense, covenant not to sue, or other grant of rights under this
Agreement pursuant to the terms of this Agreement.

 

1.157                 “Sued Party” is defined in Section 7.7.2.

 

1.158                 “Summary Statement” is defined in Section 4.2.3.

 

1.159                 “Supply Agreement” means the Manufacturing and Supply
Agreement to be entered into pursuant to Section 3.3.1.

 

16

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.160                 “Supply Costs” means, for a given period, (a) the sum of
(i) the quantity of Product sold by AstraZeneca or its Affiliates in the
Territory in such period and (ii) the quantity of Product written off by
AstraZeneca or its Affiliates in accordance with Accounting Standards (e.g.,
expired Product or Product otherwise rendered unusable), in each case ((i) and
(ii)), multiplied by [**].

 

1.161                 “Supply Price” will have the meaning set forth in the
Supply Agreement (see Exhibit B).

 

1.162                 “Tax” or “Taxation” means any form of tax or taxation,
levy, duty, charge, social security charge, contribution, or withholding of
whatever nature (including any related fine, penalty, surcharge or interest)
imposed by, or payable to, a Tax Authority.

 

1.163                 “Tax Authority” or “Tax Authorities” means any government,
state or municipality, or any local, state, federal or other fiscal, revenue,
customs, or excise authority, body or official anywhere in the world, authorized
to levy tax.

 

1.164                 “Tax Invoice” means an invoice including such particulars
as are required by any law imposing Tax and such other information as required
to claim any credit allowed under a law imposing Tax.

 

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

 

1.166                 “Term” is defined in Section 8.1.

 

1.167                 “Territory” the People’s Republic of China, including Hong
Kong and Macau, but excluding Taiwan.

 

1.168                 “Third Party” means any Person other than Ironwood,
AstraZeneca and their respective Affiliates.

 

1.169                 “Third Party Claims” is defined in Section 9.1.

 

1.170                 “Trademark” means all trademarks, service marks, trade
names, brand names, sub-brand names, trade dress rights, product configuration
rights, certification marks, collective marks, logos, taglines, slogans, designs
or business symbols and all words, names, symbols, colors, shapes, designations
or any combination thereof that function as an identifier of source or origin or
quality, whether or not registered, and all statutory and common law rights
therein, and all registrations and applications therefor, together with all
goodwill associated with, or symbolized by, any of the foregoing.

 

1.171                 “Trigger Year” means the first Year in which [**].

 

1.172                 “U.S. Bankruptcy Code” means Title 11, United States Code,
as amended, or analogous provisions of Applicable Law outside the United States.

 

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

 

17

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.174                 “Valuation Panel” means a panel of [**]. In the event the
Parties are required to select a Valuation Panel, each Party will [**]. Each
Party will [**]. The decision of [**] will be deemed the decision of the
Valuation Panel. The Parties will instruct the Valuation Panel to reach its
decision as promptly as practicable, but within [**]. The costs of this
Valuation Panel will be [**].

 

1.175                 “Year” means each 12 month period ending December 31st.

 

2.                                      LICENSE GRANT

 

2.1.                                              License to AstraZeneca. 
Subject to the terms and conditions of this Agreement, Ironwood hereby grants to
AstraZeneca, a perpetual (except as otherwise provided in Section 8), exclusive,
nontransferable (except as set forth in Section 10.9) license, with the right to
grant sublicenses as described in Section 2.6 and, subject only to the rights
reserved to Ironwood to the extent necessary to perform its obligations or
exercise its rights hereunder under the Ironwood Technology and Ironwood’s
interest in the Joint Technology and Development Data to Develop the Licensed
Compound and Products pursuant to the Development Plans and to Commercialize
Products pursuant to the Commercialization Plans in each case, in the Field in
the Territory and, subject to Section 3.3, to make or have made the Licensed
Compound or Products anywhere in the world for Development or Commercialization
in the Field in the Territory. Notwithstanding the foregoing, Ironwood reserves
the right under the Ironwood Technology and Ironwood’s interest in the Joint
Technology and the Development Data to (a) subject to Section 3.2.5(c), develop
and manufacture the Licensed Compound and Products inside or outside of the
Territory in support of development or commercialization of the Licensed
Compound and Products outside of the Territory, (b) Develop and Manufacture the
Licensed Compound and Products in the Territory and Commercialize the Products
in the Territory in the Field pursuant to Section 3.5.4 upon exercise of
Ironwood’s rights thereunder, (c) develop and commercialize the Licensed
Compound and Products in the Territory outside of the Field, and
(d) commercialize the Licensed Compound and Products outside of the Territory,
in each case ((a) through (d)) in accordance with any applicable terms of this
Agreement. Unless and until specified in Section 5.3, [**]. The Parties
acknowledge that the Development Plan currently contemplates and may in the
future contemplate certain Development activities for the Territory that may
occur outside the Territory and agree that such Development activities for such
purpose shall be considered in the Territory for purposes of this Agreement.

 

2.2.                                              License to Ironwood. Subject
to the terms and conditions of this Agreement, AstraZeneca hereby grants to
Ironwood (a) a perpetual, royalty-free, exclusive, nontransferable (except as
set forth in Section 10.9) license, with the right to sublicense to any Third
Party to the extent that corresponding rights are granted to Ironwood by its
Sublicensee and sublicensed to AstraZeneca hereunder, under the AstraZeneca
Technology to develop, manufacture and commercialize the Licensed Compound or
Products outside of the Territory and to develop and manufacture the Licensed
Compound or Products in the Territory for purposes of commercialization

 

18

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

outside of the Territory or commercialization in the Territory outside of the
Field, (b) a perpetual, royalty-free, exclusive, nontransferable (except as set
forth in Section 10.9) license, with the right to sublicense to any Third Party
to the extent that corresponding rights are granted to Ironwood by its
Sublicensee and sublicensed to AstraZeneca hereunder, under AstraZeneca’s
interest in the Joint Technology and Development Data to develop, manufacture
and commercialize the Licensed Compound or Products or any other GC-C Agonist
outside of the Territory and to develop and manufacture the Licensed Compound or
Products or any other GC-C Agonist in the Territory for purposes of
commercialization outside of the Territory or commercialization in the Territory
outside of the Field and (c) a perpetual, royalty-free, non-exclusive,
nontransferable (except as set forth in Section 2.6 and Section 10.9) license
under the AstraZeneca Technology and AstraZeneca’s interest in the Joint
Technology and Development Data to Develop and Manufacture the Licensed Compound
or Products in the Territory, to Commercialize the Products in the Territory in
the Field pursuant to Section 3.5.4 upon exercise of Ironwood’s rights
thereunder and to perform its obligations under this Agreement, all in
accordance with any applicable terms of this Agreement.

 

2.3.                                              Joint Technology and
Development Data. Subject to the terms and conditions of this Agreement, each
Party hereby grants the other Party a world-wide, non-exclusive, perpetual,
royalty-free, fully paid up, freely sublicensable right and license under its
interest in the Joint Technology and the Development Data (a) to exploit
compounds that are not GC-C Agonists and products containing compounds that are
not GC-C Agonists anywhere in the world, and (b) without compensating or
accounting to the other Party.

 

2.4.                                              Rights of Reference. Ironwood
hereby grants to AstraZeneca a “Right of Reference,” as that term is defined in
21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, to the
Referenced Regulatory Filings and the Development Data to the extent necessary
or useful to Develop, Manufacture or Commercialize the Licensed Compound or
Product in the Field in the Territory, in each case, pursuant to the Development
Plan or Commercialization Plan and otherwise subject to the terms and conditions
of this Agreement. AstraZeneca hereby grants to Ironwood (and any current or
future licensee by Ironwood of the Licensed Compound) such a Right of Reference
to the Development Data to the extent necessary or useful to (a) subject to
Section 3.2.5(c), develop and manufacture the Licensed Compound and Products
inside or outside of the Territory in support of development or
commercialization of the Licensed Compound and Products outside of the
Territory, (b) Develop and Manufacture the Licensed Compound and Products in the
Territory and Commercialize Products in the Territory in the Field pursuant to
Section 3.5.4 upon exercise of Ironwood’s rights thereunder, (c) develop and
commercialize the Licensed Compound and Products in the Territory outside of the
Field or manufacture the Licensed Compound and Products in the Territory for use
outside of the Field and (d) commercialize the Licensed Compound and Products
outside of the Territory, in each case ((a) through (d)) in accordance with any
applicable terms and conditions of this Agreement. Each Party will provide a
signed statement to this effect, if requested by the other Party, in accordance
with 21 C.F.R.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

§ 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a
request by either Party, for the limited purpose described in this Section 2.4.
For the avoidance of doubt, neither Party may publish or otherwise publicly
disclose any data of the other Party to which a Right of Reference is granted
under this Section 2.4 except in accordance with this Agreement.

 

2.5.                                              Use of Third Party
Contractors. Subject to Section 3.2.5(a) and Section 3.5.5, the Supply Agreement
and the Quality Assurance Agreement, (a) AstraZeneca may grant a Sublicense of
its rights under this Agreement to [**], provided that [**], provided further,
that if [**], then [**], and (b) Ironwood may grant a Sublicense of its rights
under this Agreement to [**], provided, that, [**].

 

2.6.                                              Sublicensing.  Each Party may
only sublicense the rights granted to such Party under this Agreement as
provided in Section 2.2, Section 2.3, Section 2.5 and Section 8.5 and in
accordance with the provisions of Section 3.2.5(a) and Section 3.5.5. Any
Sublicenses granted by either Party pursuant to such Sections will be consistent
with the terms of this Agreement. In addition, each Party will require any
licensee with respect to the Licensed Compound or Product or Sublicensee,
whether within or outside the Territory, to cross-license or otherwise transfer
or convey back to the granting Party all Technology which such licensee or
Sublicensee may develop or acquire in connection with its activities with
respect to the Licensed Compound and Products that would constitute Ironwood
Technology or AstraZeneca Technology if arising under Ironwood’s or
AstraZeneca’s (or their respective Affiliates’) activities, respectively, so
that any such Technology will be Controlled by the granting Party for purposes
and to the extent of the licenses to the other Party provided by Sections 2.1,
2.2 and 2.3 above. Notwithstanding the foregoing, [**].

 

2.7.                                              Section 365(n). All rights and
licenses granted under or pursuant to this Agreement by AstraZeneca or Ironwood
are, and will otherwise be deemed to be, for purposes of Section 365(n) of the
U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined
under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the
Parties, as licensees of such rights under this Agreement, will retain and may
fully exercise all of their rights and elections under the U.S. Bankruptcy Code.
The Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against either Party under the U.S. Bankruptcy Code, the Party
hereto that is not a party to such proceeding will be entitled to a complete
duplicate of (or complete access to, as appropriate) any such intellectual
property and all embodiments of such intellectual property, and same, if not
already in their possession, will be promptly delivered to them (a) upon any
such commencement of a bankruptcy proceeding upon their written request
therefor, unless the Party subject to such proceeding elects to continue to
perform all of its obligations under this Agreement, or (b) if not delivered
under (a) above, following the rejection of this Agreement by or on behalf of
the Party subject to such proceeding upon written request therefor by the
non-subject party.

 

2.8.                                              No Other Rights. No rights,
other than those expressly set forth in this Agreement are granted to either
Party hereunder, and no additional rights will be

 

20

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

deemed granted to either Party by implication, estoppel, or otherwise. All
rights not expressly granted by either Party to the other hereunder are
reserved.

 

3.                                      DEVELOPMENT, REGULATORY, AND
COMMERCIALIZATION

 

3.1.                                              Development.

 

3.1.1.                                                  Joint Development
Committee.

 

(a)                                 Overview. Within 45 days after the Effective
Date, the Parties will establish a joint development committee (“JDC”). The JDC
will be responsible for overseeing the Development of Products in the Field in
the Territory, and will serve as a forum for exchanging data, information, and
Development strategy regarding the Products in the Territory. The Parties
anticipate that the JDC will perform the functions ascribed to it in this
Section 3.1.1; provided, however, that the functions and operations of the JDC
may be altered from time to time during the Term by the mutual written agreement
of the Parties to appropriately address ongoing requirements with respect to the
Development of the Product in the Territory.

 

(b)                                 Membership. The JDC will consist of three
senior representatives from each Party of appropriate seniority and geographical
responsibility. Ironwood and AstraZeneca will each designate a co-chair for the
JDC. The co-chairs of the JDC will be responsible for calling meetings of the
JDC and setting the agenda for such meetings (which will include a list of all
participants expected at such meeting) and circulating such agenda at least ten
days, or such other period as agreed by the co-chairs, prior to each such
meeting and distributing minutes of each meeting within 30 days following such
meeting (which minutes will be in the English language), but will not otherwise
have any greater power or authority than any other member of the JDC. JDC
members must have such expertise as appropriate to the activities of the JDC.
From time to time, the JDC may invite personnel of the Parties having
formulation, manufacturing, commercial and other expertise to participate in
discussions of the JDC as appropriate to assist in the activities of the JDC.

 

(c)                                  Responsibilities. Subject to
Section 3.1.1(a), the JDC’s responsibilities will be: (i) reviewing and
approving the Development Plan no less than once per Year and any amendments
thereto; (ii) reviewing and approving the Development Budget no less than once
per Year and any amendments thereto; (iii) approving (or establishing procedures
to approve) protocols for non-clinical or clinical studies (including
Post-Approval Research) conducted for purposes of seeking Regulatory Approval
for the Product in the Territory; (iv) making modifications to and performing
quarterly monitoring of progress of such non-clinical and clinical studies and
proposing additional studies for the Product in the

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Territory; (v) reviewing and commenting on Regulatory Submissions relating to
the Product in the Territory and approving such Regulatory Submissions as
specified in Exhibit D; (vi) subject to Section 3.8, developing and coordinating
a strategy for publications relating to the Product in the Territory to be made
by the Parties and their respective Affiliates, licensees and Sublicensees;
(vii) subject to Sections 3.2.2, 3.2.3 and 3.2.4 and any other applicable terms
of this Agreement, facilitating the exchange of all data, information, material
or results relating to the Development of the Product in the Territory;
(viii) facilitating the exchange of Ironwood Know-How that is necessary or
useful for AstraZeneca to conduct Development activities; and (ix) developing
procedures for monitoring Third Party submissions to Regulatory Authorities in
the Territory with respect to the Products. The JDC may appoint additional
committees as desired. Without limiting the foregoing, AstraZeneca acknowledges
and agrees that any Development Plan approved by the JDC will be subject to
review by the Joint Development Committee constituted under the Forest
Agreement, and that no clinical Development of the Product may be conducted in
the Forest Territory which Forest reasonably believes may adversely affect the
timely development of any Product in the Forest Territory; provided that the
foregoing provisions of this sentence apply solely to the extent and for so long
as Forest has such rights under the Forest Agreement.

 

(d)                                 Meetings. The first meeting of the JDC will
take place within 45 days after the Effective Date in a location outside of the
United States. Thereafter, during Development in the Territory, the JDC will
meet at such frequency as will be established by the Parties (but not less
frequently than once per Calendar Quarter). Meetings of the JDC will be [**] and
will alternate between a location selected by AstraZeneca and a location
selected by Ironwood, unless otherwise agreed upon by the members of the JDC, or
may be held telephonically or by video conference. Meetings of the JDC will be
effective only if at least one representative of each Party is in attendance or
participating in the meeting. JDC members may participate in and vote at
meetings by telephone. Each Party will be responsible for expenses incurred by
its employees and its members of the JDC in attending or otherwise participating
in JDC meetings. Such expenses shall not constitute Program Expenses. Each Party
will use reasonable efforts to cause its representatives to attend the meetings
of the JDC. If a representative of a Party is unable to attend a meeting, such
Party may designate an alternate with equivalent experience and authority as
such representative to attend such meeting in place of the absent
representative.

 

(e)                                  Minutes. The minutes of each JDC meeting
will provide a description in reasonable detail of the discussions held at the
meeting and a list of any actions, decisions or determinations approved by the
JDC.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Minutes of each JDC meeting will be approved or disapproved, and revised as
necessary, at the next meeting.

 

(f)                                   Elevation and Dispute Resolution. Each
Party’s representatives on the JDC will collectively have one vote on all
matters that are within the responsibility of the JDC. The members of the JDC
will use reasonable efforts to reach consensus on all decisions. In the event
that the members of a JDC are unable to agree on a particular issue after
endeavoring to reach consensus for a period of 30 days (a “JDC Deadlock”), at
the request of either Party, such JDC Deadlock will be submitted to
AstraZeneca’s VP CVGI gMED and Ironwood’s Chief Scientific Officer or, in each
case, his or her designees. Such executives or their designees will meet (in
person or by teleconference) to attempt in good faith to resolve such JDC
Deadlock through discussions promptly following submission thereof, and in any
event within 15 days thereafter, unless otherwise mutually agreed upon by the
executives or their designees. In the event such individuals are unable to
resolve such issue within 15 days, such issue will be referred to the Chief
Executive Officer of Ironwood and the EVP of Global Medicines Development of
AstraZeneca or, in each case, his or her designee for resolution. Such
executives or their designees will meet (in person or by teleconference) to
attempt in good faith to resolve such JDC Deadlock through discussions promptly
following submission thereof, and in any event within 15 days thereafter, unless
otherwise mutually agreed upon by the executives or their designees. If a matter
for which consensus cannot be reached following escalation in accordance with
this Section 3.1.1(f) is addressed by the Development Plan, then [**].

 

3.1.2.                                                  Development Plan. The
initial Development Plan is set forth in Exhibit A (the “Initial Development
Plan”). The JDC will direct, coordinate, and manage the Development of the
Product in the Field, according to the Development Plan. The Development Plan
will include, among other things, the indications in the Field for which the
Product is to be Developed and other exploratory indications in the Field for
which the Product may be developed, critical activities to be undertaken,
certain timelines, go/no go decision points and relevant decision criteria and
certain allocations of responsibilities between the Parties for the various
activities to be undertaken under the Development Plan. During the Term, the JDC
will review the Development Plan and Development Budget at least once per Year
and will amend such Development Plan and Development Budget on an ongoing basis
as necessary. The then-current Development Plan will at all times contain at
least that level of detail and cover at least the same matters (to the extent
applicable) as the Initial Development Plan.

 

3.1.3.                                                  Development
Responsibility.

 

(a)                                 Except as specifically set forth in the
Development Plan, using the efforts set forth in Section 3.1.4, AstraZeneca will
implement and conduct

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

all clinical Development activities set forth in the Development Plan in
accordance with the Development Plan, Applicable Law and GCP.

 

(b)                                 Except as otherwise provided in the
Development Plan,  Ironwood will implement and conduct any non-clinical
Development activities set forth in the Development Plan using the efforts set
forth in Section 3.1.4 in accordance with such Development Plan and Applicable
Law and AstraZeneca will not conduct any such non-clinical Development
activities. If Ironwood is assigned any Development activities under this
Agreement, Ironwood will conduct such activities in accordance with the
Development Plan, Applicable Law and GCP.

 

3.1.4.                                                  Diligence. Each Party
will use Commercially Reasonable Efforts to conduct the Development activities
assigned to it in the Development Plan and all activities reasonably necessary
to achieve the goals of such assigned activities.

 

3.1.5.                                                  Future Development
Activities. The JDC will make recommendations regarding whether to Develop a
Product for new indications or new formulations. Any such recommendations that
are approved by the JDC will become part of the Development Plan.

 

3.1.6.                                                  Reports of Development
Activities. Each Party will report on Development activities undertaken by it in
accordance with the Development Plan in connection with meetings of the JDC,
including by providing a reasonably detailed summary of all results, data, and
material Collaboration Know-How generated from such activities. In addition,
each Party will, at its own expense, make appropriate scientific and regulatory
personnel available to the other Party, either by telephone or in person as the
Parties may mutually agree, as reasonably required to keep such other Party
informed of Development activities. Ironwood will keep AstraZeneca reasonably
informed on activities undertaken by Ironwood or Third Party licensees of the
Product, including Forest, Almirall and Astellas, relating to the development of
the Product outside of the Territory. Without limitation of any specific
disclosure obligations of Ironwood hereunder, Ironwood shall disclose [**] any
Ironwood Know-How that is necessary for AstraZeneca to conduct its activities
hereunder and the applicable committees shall establish, in good faith, the
manner and procedures for disclosing any other Ironwood Know-How relevant to the
applicable activities.

 

3.2.                                              Regulatory Matters.

 

3.2.1.                                                  Responsibility For
Regulatory Interactions. Regulatory strategy for the Products in the Territory
and all decision-making with respect thereto will be determined by the JDC.
Subject to the other Party’s conduct of activities allocated to such other Party
under the Development Plan, the Responsible Party will use Commercially
Reasonable Efforts to obtain in a timely manner

 

24

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

all Regulatory Approvals in the Territory with respect to the Product to the
extent contemplated by the Development Plan and in accordance with such
Development Plan. Each Party will use Commercially Reasonable Efforts to obtain
and maintain Regulatory Approvals outside of the Territory that are necessary to
obtain Regulatory Approval for the Product in the Territory in accordance with
the Development Plan to the extent such activities are assigned to each Party in
the Development Plan and the costs and expenses of such efforts [**]; provided,
however that neither Party will be required to take any action to obtain such
approvals unless [**]. The Responsible Party will conduct all activities
relating to obtaining Regulatory Approvals with respect to the Product in the
Territory, including preparing and submitting Regulatory Submissions and
attending meetings with Regulatory Authorities in the Territory. [**] will own
all right, title, and interest in all Regulatory Submissions and Regulatory
Approvals for Products in the Territory.

 

3.2.2.                                                  Regulatory Cooperation.
Each Party will keep the other Party reasonably informed regarding the status
and progress of its Development activities relating to the obtaining,
maintaining or expanding of any Regulatory Approval in accordance with the
provisions set forth on Exhibit D. Subject to the Development Budget and
Section 4.2.6, all costs and expenses incurred by a Party in carrying out its
allocated regulatory activities pursuant to this Agreement [**].

 

3.2.3.                                                  Clinical Trial Data.
[**] will be responsible, at its own expense, for maintaining a database of
clinical trial data being developed under this Agreement [**]. Also at its
expense, [**] will provide [**] with copies of any such clinical trial data that
is necessary or useful in connection with any Regulatory Submission made by [**]
in the Territory.

 

3.2.4.                                                  Adverse Events. The
Parties will use good faith efforts to enter into a pharmacovigilance agreement
within 30 days after the Effective Date, or earlier if required by Applicable
Law and will be incorporated into this Agreement by reference (the
“Pharmacovigilance Agreement”). The Parties will comply and cause their
respective Affiliates to comply with the provisions of such agreement. All costs
and expenses incurred by the Parties or their respective Affiliates in
performing their respective obligations under the Pharmacovigilance Agreement
[**].

 

3.2.5.                                                  Clinical Trials.

 

(a)                                 Any clinical trials conducted in accordance
with the Development Plan by [**] will be conducted [**]. In the event that [**]
engages [**] to undertake any such clinical trial (or any portion of any
clinical trial or other clinical trial task), [**] will be qualified in such
country and capable of producing data acceptable to the Regulatory Authorities
in such country. [**] will [**]. Except as set forth in the Development Plan,
any studies conducted in the Territory will be conducted only at hospitals that
are, to

 

25

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

the extent applicable, accredited by the Regulatory Authorities for the country
in which such studies are conducted. Any studies will be conducted in accordance
with GCP and involve investigators of recognized competence. If so requested by
Ironwood, to enable Ironwood to use study data from the Territory in support of
its Regulatory Submissions outside of the Territory, AstraZeneca will permit,
and will use reasonable efforts to require any clinical trial sites to permit,
Regulatory Authorities from outside of the Territory to validate any such
clinical trial data through on-site inspections to the extent any such on-site
inspections do not materially interfere with AstraZeneca’s or such clinical
trial sites’, as applicable, day-to-day operations; provided that Ironwood
provides reasonable advance notice of such inspection, and such inspections do
not occur more than once in any given year for a given site, unless required by
applicable law.

 

(b)                                 The Parties acknowledge that [**] is
required to [**] and (i) with respect to any clinical studies that are
reasonably necessary to obtain, maintain or expand Regulatory Approval for the
Product in the Territory, [**] and (ii) with respect to any pre-clinical or
clinical studies of the Product, including Phase IV studies, that are not
required for registration or imposed by a Regulatory Authority in the Territory,
[**]. For the avoidance of doubt, any such studies that are not required for
registration or imposed by a Regulatory Authority in the Territory will
constitute Post-Approval Research under the Development Plan. The foregoing
rights of Forest apply to the extent and for so long as Forest has such rights
under the [**].

 

(c)                                  Ironwood will not conduct any clinical
trials of any Product in the Field in the Territory without the prior written
consent of AstraZeneca, such consent not to be unreasonably withheld,
conditioned or delayed.

 

3.3.                                              Supply of Products.

 

3.3.1.                                                  General. The Parties
shall negotiate and enter into the Supply Agreement no later than [**], on the
terms set forth in Exhibit B. Subject to the Supply Agreement, (a) Ironwood will
be the exclusive supplier of Clinical Trial Material and Product, in each case,
for use in the Field in the Territory (which shall be supplied in fully packaged
and labeled form and, if applicable, in such other forms as determined in
accordance with the Supply Agreement), and (b) AstraZeneca will order its
requirements for Clinical Trial Material and such Product from Ironwood, which
exclusivity and requirement commitments will be subject to the failure to supply
and other provisions under the Supply Agreement. For the avoidance of doubt, the
supply by Ironwood of Product is outside the scope of this collaboration and
governed separately by the Supply Agreement. Ironwood represents and warrants
that [**] and in particular that [**] and that [**].

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

3.3.2.                                                  Recall. To the extent
not constituting Third Party Claims covered by Section 9.1, 9.2 or 9.3, the
costs and expenses of any recall or product withdrawal of a Product in the
Territory for Product sold during the Term (even if incurred after the Term)
[**].

 

3.4.                                              Operations.

 

3.4.1.                                                  Joint Operations
Committee.

 

(a)                                 General. Within [**] days after the
Effective Date, the Parties will establish a joint operations committee (“JOC”).
The JOC will oversee the supply to AstraZeneca of Clinical Trial Material and
Products for Development and Commercialization in the Field in the Territory.
The JOC will coordinate supply efforts under the Supply Agreement for the
Territory and will serve as a forum regarding the foregoing in the Field in the
Territory. The Parties anticipate that the JOC will perform the functions
ascribed to it in this Section 3.4.1; provided, however, that the functions and
operations of the JOC may be altered from time to time during the Term by the
mutual written agreement of the Parties to appropriately address ongoing
requirements with respect to the supply of Clinical Trial Material and Products
for Development and Commercialization in the Territory.

 

(b)                                 Membership. The JOC will consist of three
senior representatives of appropriate seniority and geographical responsibility
from each Party. Ironwood and AstraZeneca will each designate a co-chair for the
JOC. The co-chairs of the JOC will be responsible for calling meetings of the
JOC and setting the agenda for such meetings (which will include a list of all
participants expected at such meeting) and circulating such agenda at least ten
days, or such other period as agreed by the co-chairs, prior to each meeting and
distributing minutes of each meeting within 30 days following such meeting
(which minutes will be in the English language), but will not otherwise have any
greater power or authority than any other member of the applicable JOC. JOC
members must have such expertise as appropriate to the activities of the
applicable JOC. From time to time, the JOC may invite personnel of the Parties
having development, manufacturing, financial and other expertise to participate
in discussions of the JOC as appropriate to assist in its activities.

 

(c)                                  Responsibilities. Subject to
Section 3.4.1(a) and the terms of the Supply Agreement, the JOC will be
responsible for overseeing supply matters, including future capacity plans,
sourcing strategies, technology transfers, and other related issues, in each
case, relating to the Territory, and for those matters specified in the Supply
Agreement. Notwithstanding anything to the contrary herein, the JOC, rather than
the JDC, shall be responsible for oversight of scale-up of the Product, provided
that any budget therefor shall be by consensus and subject to clause
(i)(C) below.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

The JOC may, by consensus, approve (i) [**], provided that, unless otherwise
agreed by the JOC, the Supply Price will include [**], and (ii) reimbursement of
[**], to the extent not included in Supply Costs.  Except for [**], each Party
shall be [**].

 

(d)                                 Meetings. The first meeting of the JOC will
take place within 120 days after the Effective Date at a location outside the
United States. Thereafter, the JOC will meet at such frequency as will be
established by the Parties (but not less frequently than once per Calendar
Quarter). Meetings of the JOC will be held [**] and alternate between a location
selected by AstraZeneca and a location selected by Ironwood, unless otherwise
agreed upon by the members of the JOC, or may be held telephonically or by video
conference. Meetings of the JOC will be effective only if at least one
representative of each Party is in attendance or participating in the meeting.
JOC members will have the right to participate in and vote at meetings by
telephone. Each Party will be responsible for expenses incurred by its employees
and its members of the JOC in attending or otherwise participating in JOC
meetings. Such expenses shall not constitute Program Expenses. If a
representative of a Party is unable to attend a meeting, such Party may
designate an alternate with equivalent experience and authority as such
representative to attend such meeting in place of the absent representative.

 

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

 

(f)                                   Elevation and Dispute Resolution. Each
Party’s representatives on the JOC will collectively have one vote on all
matters that are within the responsibility of such committee. The members of the
JOC will use reasonable efforts to reach consensus on all decisions. In the
event that the members of the JOC are unable to agree on a particular issue
after endeavoring to reach consensus for a period of 30 days (a “JOC Deadlock”),
at the request of either Party, such JOC Deadlock will be submitted to the Head
of Global Operations of Ironwood and the VP of Global External Sourcing of
AstraZeneca, or, in each case, his or her designee for resolution. Such
executives or their designees will meet (in person or by teleconference) to
attempt in good faith to resolve such JOC Deadlock through discussions promptly
following submission thereof, and in any event within 15 days thereafter, unless
otherwise mutually agreed upon by the executives or their designees. In the
event such individuals are unable to resolve such JOC Deadlock within 15 days,
at the request of either Party, such JOC Deadlock will be submitted to the Chief
Executive Officer of Ironwood and the EVP of Operations of AstraZeneca, or, in
each case, his or her designee for resolution. Such executives or their

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

designees will meet (in person or by teleconference) to attempt in good faith to
resolve such JOC Deadlock through discussions promptly following submission
thereof, and in any event within 15 days thereafter, unless otherwise mutually
agreed upon by the executives or their designees. If such individuals are unable
to resolve such JOC Deadlock within 15 days following submission thereof, then
[**].

 

3.4.2.                                                  Quality Assurance
Agreement. The Parties will use good faith efforts to enter into one or more
agreement(s) governing the quality standards required under this Agreement or by
any Third Party vendors or subcontractors of either Party (the “Quality
Assurance Agreement”) within 45 days after execution of the Supply Agreement, or
earlier if required by Applicable Law.

 

3.5.                                              Commercialization in the
Territory.

 

3.5.1.                                                  Joint Commercialization
Committee.

 

(a)                                 General. Within [**] days after the
Effective Date, the Parties will establish a joint commercialization committee
(“JCC”). The JCC will oversee the Commercialization of the Product in the Field
in the Territory. The JCC will coordinate selling and marketing efforts under
the Commercialization Plan and will serve as a forum regarding Product
Commercialization in the Field in the Territory. The Parties anticipate that the
JCC will perform the functions ascribed to it in this Section 3.5.1; provided,
however, that the functions and operations of the JCC may be altered from time
to time during the Term by the mutual written agreement of the Parties to
appropriately address ongoing requirements with respect to the Commercialization
of the Product in the Territory.

 

(b)                                 Membership. The JCC will consist of three
senior representatives of appropriate seniority and geographical responsibility
from each Party. Ironwood and AstraZeneca will each designate a co-chair for the
JCC. The co-chairs of the JCC will be responsible for calling meetings of the
JCC and setting the agenda for such meetings (which will include a list of all
participants expected at such meeting) and circulating such agenda at least ten
days, or such other period as agreed by the co-chairs, prior to each meeting and
distributing minutes of each meeting within 30 days following such meeting
(which minutes will be in the English language), but will not otherwise have any
greater power or authority than any other member of the applicable JCC. JCC
members must have such expertise as appropriate to the activities of the
applicable JCC. From time to time, the JCC may invite personnel of the Parties
having development, manufacturing, financial and other expertise to participate
in discussions of the JCC as appropriate to assist in its activities.

 

(c)                                  Responsibilities. Subject to
Section 3.5.1(a), the JCC will be responsible for: (i) reviewing and approving
the Commercialization Plan

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

no less than once per Year and any amendments thereto (after the Initial
Commercialization Plan is established pursuant to Section 3.5.1(g));
(ii) reviewing and approving the Commercialization Budget no less than once per
Year and any amendments thereto (after the initial Commercialization Budget is
established pursuant to Section 3.5.1(g)); (iii) establishing the
Commercialization strategy for the Territory, which strategy will be embodied in
the Commercialization Plan, and otherwise generally monitoring the
implementation of the strategy for Commercializing Product(s) in the Field in
the Territory (including strategies related to Regulatory Approvals,
reimbursement, advertising and promotion, brand integrity, sales, and launch
sequence); (iv) establishing [**]; (v) reviewing the annual marketing plans for
Product(s) in the Field in the Territory; (vi) reviewing marketing and
promotional activities for Product(s) in the Field in the Territory;
(vii) reviewing usage instructions for and selecting the Product Trademarks and
Product Domain Names in the Territory; (viii) preparing and providing the JOC
with a forecast of anticipated demand for Product(s) in the Territory for use by
the JOC in managing the supply chain for the Licensed Compound and Product(s),
which forecast will be based upon the projections in the Commercialization Plan;
(ix) facilitating [**]; and (x) other matters assigned to the JCC hereunder.
Notwithstanding anything in this Agreement to the contrary, pricing and the
commercial aspects of obtaining price approvals shall be considered within the
jurisdiction of the JCC rather than the JDC.

 

(d)                                 Meetings. The first meeting of the JCC will
take place within 120 days after the Effective Date at a location outside the
United States. Thereafter, the JCC will meet at such frequency as will be
established by the Parties (but not less frequently than once per Calendar
Quarter). Meetings of the JCC will be held [**] and alternate between a location
selected by AstraZeneca and a location selected by Ironwood, unless otherwise
agreed upon by the members of the JCC, or may be held telephonically or by video
conference. Meetings of the JCC will be effective only if at least one
representative of each Party is in attendance or participating in the meeting.
JCC members will have the right to participate in and vote at meetings by
telephone. Each Party will be responsible for expenses incurred by its employees
and its members of the JCC in attending or otherwise participating in JCC
meetings. Such expenses shall not constitute Program Expenses. If a
representative of a Party is unable to attend a meeting, such Party may
designate an alternate with equivalent experience and authority as such
representative to attend such meeting in place of the absent representative.

 

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

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(f)                                   Elevation and Dispute Resolution. Each
Party’s representatives on the JCC will collectively have one vote on all
matters that are within the responsibility of such committee. The members of the
JCC will use reasonable efforts to reach consensus on all decisions. In the
event that the members of the JCC are unable to agree on a particular issue
within its authority, after endeavoring to reach consensus for a period of 30
days (a “JCC Deadlock”), at the request of either Party, such JCC Deadlock will
be submitted to the Chief Commercial Officer of Ironwood and the Senior Vice
President of GRA & KA of AstraZeneca’s Chinese Affiliate responsible for
Commercializing the Product in the Territory or, in each case, his or her
designee for resolution. Such executives or their designees will meet (in person
or by teleconference) to attempt in good faith to resolve such JCC Deadlock
through discussions promptly following submission thereof, and in any event
within 15 days thereafter, unless otherwise mutually agreed upon by the
executives or their designees. In the event such individuals are unable to
resolve such JCC Deadlock within 15 days, at the request of either Party, such
JCC Deadlock will be submitted to the Chief Executive Officer of Ironwood and
the Chief Operating Officer of AstraZeneca’s Chinese Affiliate responsible for
Commercializing the Product in the Territory, as applicable, or, in each case,
his or her designee for resolution. Such executives or their designees will meet
(in person or by teleconference) to attempt in good faith to resolve such JCC
Deadlock through discussions promptly following submission thereof, and in any
event within 15 days thereafter, unless otherwise mutually agreed upon by the
executives or their designees. If such individuals are unable to resolve such
JCC Deadlock within 15 days following submission thereof, if such JCC Deadlock
is addressed by the then-current Commercialization Plan, then [**]. 
Notwithstanding the foregoing, [**].

 

(g)                                  Commercialization Plan. The JCC will use
good faith efforts to approve an initial Commercialization Plan (the “Initial
Commercialization Plan”) and a corresponding Commercialization Budget in
accordance with this Section 3.5.1(g) no later than the date that is [**] months
prior to the date on which the JCC anticipates that the First Commercial Sale
will occur in the Territory. After the adoption of the initial Commercialization
Plan, for the remainder of the Term, the JCC will review the Commercialization
Plan and Commercialization Budget at least once per Year and will amend such
Commercialization Plan on an ongoing basis as necessary. The then-current
Commercialization Plan will at all times contain at least that level of detail
and cover at least the same matters (to the extent applicable) as the Initial
Commercialization Plan. The Commercialization Plan will be binding for the first
Year that is the subject thereof and will cover an additional period that is
consistent with the period covered by commercialization plans of AstraZeneca (or
its applicable Affiliate) for other similar products in the Territory.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

3.5.2.                                                  Responsibility. Subject
to Ironwood’s co-promotion rights under Section 3.5.4, AstraZeneca will be
responsible for, and will control, the implementation of the Commercialization
Plan, and will book (directly itself or indirectly through any of its Affiliates
and Sublicensees) all sales of Products and will have the sole responsibility
for the sale, invoicing, promotion, and distribution of the Product in the
Territory. AstraZeneca will be responsible for operating the Product Domain
Names, including the content thereof, subject to the Commercialization Plan and
Commercialization Budget. Ironwood will use Commercially Reasonable Efforts to
assist AstraZeneca in enabling AstraZeneca to have its corporate name and logo
on the Product packaging in the Territory.

 

3.5.3.                                                  Diligence. Each Party
will use Commercially Reasonable Efforts to conduct the Commercialization
activities assigned to it in the Commercialization Plan, including the
performance of Detailing in accordance therewith, and all activities reasonably
necessary to achieve the goals of such assigned activities. AstraZeneca will use
Commercially Reasonable Efforts to achieve the First Commercial Sale of the
Product in the Territory within [**] months of receiving Regulatory Approval
(including, for the avoidance of doubt, where required, all final pricing,
reimbursement, and other approvals required for the First Commercial Sale) for
such Product. AstraZeneca will use Commercially Reasonable Efforts to
Commercialize the Product in the Territory after such Regulatory Approval has
been received with the intent to maximize profitability consistent with
Applicable Law.

 

3.5.4.                                                  Co-Promotion. At any
time after the latest of (a) [**] days following [**], (b) [**] days following
[**], and (c) the [**], Ironwood may elect to exercise its co-promotion rights
under this Section 3.5.4, provided that at the time of the commencement of such
co-promotion, [**]. Within [**] after receipt of notice of an election by
Ironwood, the Parties will negotiate in good faith for a period of [**] (or less
if an agreement is reached earlier) a co-promotion agreement under which
Ironwood may provide no more than [**] of the Detailing for the Product in the
Territory, unless otherwise agreed by the Parties at the time. In the event that
the Parties are unable to reach an agreement on the terms of any such
co-promotion despite good faith efforts within such [**] period, then Ironwood
will have no further rights to co-promote the Product in the Territory under
this Agreement. In the event Ironwood exercises its co-promotion rights under
this Section 3.5.4, AstraZeneca will assist Ironwood in training sales
representatives in all standards applicable to AstraZeneca’s promotion efforts
pursuant to Section 5.5 (and notwithstanding anything to the contrary herein,
the costs of such assistance [**]). Any co-promotion by the Parties will be
structured so that [**]. Neither Party will make any claims or statements with
respect to the Product that are not in compliance with Applicable Law and the
sales and marketing materials approved for use pursuant to the Commercialization
Plan.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

3.5.5.                                                  Commercial Sales
Organization. If AstraZeneca or Ironwood (if Ironwood exercises its co-promotion
rights pursuant to Section 3.5.4) desires to utilize a Third Party sales force
to Detail the Product in the Territory, then [**]. Any such sales force will be
required to agree in writing to meet the quality, ethical and compliance
standards undertaken by AstraZeneca or Ironwood (as the case may be, including,
but not limited to, all of AstraZeneca’s policies regarding engagement of health
care professionals and all standards applicable to AstraZeneca’s promotion
efforts pursuant to Section 5.5) or applicable to such Party’s Detailing
activities hereunder, and will not have been found to have committed a material
violation of any rule or regulation of any Regulatory Authority in any country
where such Detailing will take place.

 

3.6.                                              Other Committee Matters.

 

3.6.1.                                                  Joint Responsibilities
of the JDC, JOC and JCC. In addition to the independent JDC, JOC and JCC
meetings, the JDC, JOC and JCC will coordinate to hold joint meetings as
appropriate to discuss issues which are relevant to Development, supply and
Commercialization, including, in order to: (a) discuss [**] for the Product
(including [**] given the competitive environment, and any other [**] for the
Product), (b) discuss development of the Product for [**], (c) discuss
development of [**] of the Products throughout the Territory and (d) discuss
matters relating to the Development, supply and Commercialization of the Product
in the entire Territory. Such joint meetings may be held by videoconference,
teleconference, or in person and any decisions required to be taken will be
submitted to the JDC, JOC or JCC, whichever is responsible for resolution in
accordance with the terms hereof; provided that any in person meetings will be
held [**]. Each Party will be responsible for expenses incurred by its employees
and its committee members in attending or otherwise participating in joint
meetings of the JDC, JOC and JCC and such expenses shall not constitute Program
Expenses.

 

3.6.2.                                                  Other Committees. The
Parties may establish other committees or sub-committees as the Parties deem
appropriate.

 

3.6.3.                                                  Safe Harbor. If Ironwood
approves a Development Plan or Commercialization Plan (or, as applicable, an
update or amendment thereto) in the JDC, JOC or JCC, either at a meeting of any
such committee or through any of its officers to which a deadlock arising out of
any such committee has been referred, or otherwise in writing (or, as
applicable, an update or amendment thereto), [**].

 

3.7.                                              Executive Meetings. The
Parties anticipate that the Chief Executive Officer of Ironwood and
AstraZeneca’s Regional Vice President of Asia Pacific will meet periodically as
necessary or appropriate during the Term (and in any event such executives will
meet at least once per Year in person) in order to review significant issues and
developments in the Development, Manufacture and Commercialization of Products
in the Territory.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

3.8.                                              Publication.

 

3.8.1.                                                  Prior Review. Ironwood
and Forest will be afforded the opportunity to review and approve any scientific
paper or presentation with respect to any Product proposed for publication,
presentation, or distribution by AstraZeneca or its Affiliates and will have no
more than 30 days to complete such review and approval or such shorter period as
may reasonably be required by applicable publication deadlines promptly
communicated to such Party. Neither Party will unreasonably reject comments
furnished by the other Party, will comply with the other Party’s request to
delete references to its Confidential Information in any such publication or
presentation and will delay publication for such reasonable period requested by
the reviewing Party in order to permit the filing of patent applications
concerning any Ironwood Technology or AstraZeneca Technology that would be
disclosed in such publication or presentation.

 

3.8.2.                                                  Clinical Study Results.
Subject to the [**], the Parties, [**], will coordinate the disclosure of the
initiation and results of clinical studies performed pursuant to the Development
Plan or clinical studies performed by either Party’s approved licensees or
Sublicensees with respect to any Licensed Compound or Product, whether within or
outside of the Territory, to the extent required by applicable law or
AstraZeneca’s internal policies applicable to other of AstraZeneca’s products;
provided that all proposed disclosures and publications will be submitted for
expeditious review by the JDC and [**] and due regard will be given to the
comments of each Party, the maintenance of confidentiality of Confidential
Information of each Party and allowing time for intellectual property
registrations as described in Section 3.8.1. Nothing set forth in this Agreement
will be deemed to limit or restrict either Party from disclosing the results of
clinical trials (whether performed by the Parties or by Third Parties) to the
extent required by applicable law; provided, however, that AstraZeneca will not
disclose any results of clinical trials prior to the time such disclosure is
required by applicable law.

 

3.8.3.                                                  Publication by
AstraZeneca Sublicensees. No Sublicensee of AstraZeneca will be permitted to
publish or present materials regarding any Product, and any Sublicense hereunder
will contain a provision prohibiting such activities.

 

3.8.4.                          [**]

 

3.9.                                              Compliance.  AstraZeneca and
Ironwood will at all times during the Term, including during the
Commercialization of the Product in the Territory, implement and adhere to
quality and compliance standards consistent with Applicable Law, industry best
practices and reasonably acceptable to the other Party in connection with the
performance of its obligations or exercise of its rights under this Agreement.
If either Party fails to comply with its obligations under this Section 3.9 in
the Territory in a manner that has a material adverse effect on the other
Party’s rights

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

hereunder or ability to Develop or Commercialize the Product, as contemplated by
this Agreement, in the Territory, such breach will be deemed a “material breach”
hereunder and the non-breaching Party may terminate this Agreement pursuant to
Section 8.2.1 (including the provisions relating to notice and opportunity to
cure therein). Notwithstanding the foregoing, with respect to a breach of this
Section 3.9 by Ironwood, in lieu of such termination, AstraZeneca may elect
(a) to terminate Ironwood’s right to co-promote the Product(s) under
Section 3.5.4, and (b) to make all final decisions with respect to all JCC
Deadlocks for which consensus cannot be reached by the JCC, except for those JCC
Deadlocks relating to the review and approval of the Commercialization Budget,
which will continue to be subject to Section 3.5.1(f).

 

4.                                      CONSIDERATION

 

4.1.                                              Upfront Payment.  Within 10
business days after the Effective Date, AstraZeneca will pay to Ironwood
$25,000,000 as an upfront, non-creditable, non-refundable fee.

 

4.2.                                              Other Consideration.

 

4.2.1.                                                  Milestones. As
additional consideration for the rights granted to AstraZeneca pursuant to
Section 2.1, AstraZeneca will pay to Ironwood the following one-time milestone
payments within [**] after the first occurrence of each of the following events
(each, a “Milestone Event”):

 

Milestone Event

 

Milestone Payment

(a) First Year in which the aggregate annual Net Sales of all Products in the
Territory exceed [**]

 

[**]

(b) First Year in which the aggregate annual Net Sales of all Products in the
Territory exceed [**]

 

[**]

 

Once AstraZeneca has made any particular milestone payment under this
Section 4.2.1, AstraZeneca will not be obligated to make any payment with
respect to the re-occurrence of the same Milestone Event. If the Milestone
Events in both (a) and (b) above occur in the same Year, both applicable
milestone payments will be due to Ironwood.

 

4.2.2.                                                  Allocation of Net Profit
and Net Loss. Net Profits and Net Loss during the Term will be shared by the
Parties as follows:

 

(a)                                 Until and during the Trigger Year, for each
Calendar Quarter during such period:

 

(i)                                     AstraZeneca will be allocated 55% of the
Net Profit or 55% of the Net Loss, as applicable; and

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(ii)                                  Ironwood will be allocated 45% of the Net
Profit or 45% of the Net Loss, as applicable; and

 

(b)                                 After the Trigger Year, for each Calendar
Quarter remaining in the Term, each Party will be allocated 50% of the Net
Profit and 50% of the Net Loss, as applicable.

 

4.2.3.                                                  Payment of Expenses;
Summary Statements. Subject to reconciliation as provided in Section 4.2.5, the
Party initially incurring Program Expenses will be responsible for and pay for
all such Program Expenses so incurred. Subject to the limitations set forth in
Section 4.2.4, each Party will maintain the books and records referred to in
Section 4.3 and will accrue all Program Expenses (and, in the case of
AstraZeneca, Net Sales) in accordance with the terms and conditions hereof and
in accordance with applicable Accounting Standards. Within three business days
after the end of each calendar month, each Party will submit to the other a
non-binding, good faith estimate of the Program Expenses accrued, and with
respect to AstraZeneca, Net Sales during the just-ended calendar month.  Within
three business days after the end of each Calendar Quarter, each Party will
submit to the other a written report reflecting the accrual of Program Expenses
and, with respect to AstraZeneca, Net Sales during the just-ended Calendar
Quarter, except that each Party’s submission for the last month of such Calendar
Quarter shall be a good faith estimate and not actual amounts (each a “Summary
Statement”). Each Summary Statement (after the initial Summary Statement) shall
reflect an adjustment for the actual amount of the previous Calendar Quarter as
needed. Any reporting and reconciliation of variances between estimated and
actual costs and expenses may be delayed by a Calendar Quarter as reasonably
necessary in light of a Party’s internal reporting procedures. The Parties’
respective Summary Statements will serve as the basis of the Reconciliation
Reports prepared by AstraZeneca pursuant to Section 4.2.5. Upon the request of
either Party from time to time, the Parties’ respective finance departments,
coordinated by the JDC, the JOC or JCC as appropriate, will discuss any
questions or issues arising from the Summary Statements, including the basis for
the accrual of specific Program Expenses.

 

4.2.4.                                                  Expense Limitations.
Additionally, the Parties hereby agree that efforts of the employees of a Party
or its Affiliates in performing its activities hereunder related to Development,
supply or Commercialization of the Product in the Territory will be accrued and
reported at the applicable FTE Rate then in effect; provided, however, that only
those efforts that relate to the Development or Commercialization of the Product
and are contemplated by the Development Plan or Commercialization Plan, or are
activities approved hereunder by the JOC or by mutual agreement of the Parties
for purposes of Developing or Commercializing the Product in the Territory or
under the Supply Agreement for such purposes, will be so accrued and reported.
All payments made by a Party (or its Affiliates) to a Third Party in connection
with the Development and Commercialization of the Product in the Territory
consistent with the

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Development Plan, the Commercialization Plan or activities approved hereunder or
under the Supply Agreement for purposes of Developing or Commercializing the
Product in the Territory will be accrued and reported [**]. Expenses incurred by
each Party for [**] in performing its activities under the Development Plan or
Commercialization Plan [**] (with the prior written consent of the JDC or JCC,
as applicable, or as expressly provided for in the Development Plan or
Commercialization Plan) [**] and to the extent to be used [**] the
Commercialization Plan or in procuring Clinical Trial Material or Product for
purposes of Development or Commercialization of the Product, as applicable, in
the Territory, which expenses will be [**]. In the event of a conflict between
this Section 4.2.4 and the definition of Supply Price, the definition of Supply
Price shall control and in no event is this Section 4.2.4 intended to expand or
modify the manner in which Supply Price is calculated. For clarity, a Party may
be reimbursed for a cost hereunder and under the Supply Agreement only once for
such cost and in no event can an amount be taken as both a deduction under Net
Sales and as a reimbursable expense under this Agreement (i.e., no double
counting). In no event may a Party include in its Program Expenses any amounts
that constitute an inter-company mark-up or profit to an Affiliate of such
Party, nor may a Party include any costs incurred prior to the Effective Date.
All Third Party contracts executed by a Party for purposes of Development,
supply or Commercialization hereunder shall be negotiated on an arm’s length
basis. In no event may Ironwood structure its contractual arrangements with
Third Parties in a manner designed to benefit countries outside the Territory
over those within the Territory.

 

4.2.5.                                                  Reconciliation. As soon
as practicable after the receipt by AstraZeneca of Ironwood’s Summary Statement,
but in any event within [**] days after the end of each Calendar Quarter,
AstraZeneca will prepare a reconciliation report in accordance with Exhibit C,
accompanied by reasonable supporting documents and calculations sufficient to
support each Party’s financial reporting obligations, independent auditor
requirements and obligations under the Sarbanes-Oxley Act, which reconciles the
amounts accrued and reported in each Party’s Summary Statement during such
Calendar Quarter pursuant to Section 4.2.3 and the share of the Parties’
aggregate Program Expenses and their Net Profits and Net Losses (determined
based on such Program Expenses), to be allocated to each of the Parties for such
Calendar Quarter in accordance with Section 4.2.2 (the report setting forth the
foregoing reconciliation being the “Reconciliation Report”). Based on the
Reconciliation Report, the applicable Party will invoice the other Party the
amount due under the Reconciliation Report within [**] days after such
Reconciliation Report is complete and the receiving Party will pay such invoice
within [**] days of receipt of such invoice. In the event any payment is made
after the date specified in the preceding sentence, the paying Party will
increase the amount otherwise due and payable by adding interest as provided in
Section 4.8 compounded monthly from the date such additional amount should have
first been paid; provided, however, no Party will be charged interest hereunder
to the extent it is late in making payment as a result of the other Party’s
delay in

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

reporting its Program Expenses or other information required to prepare such
reconciliation. In the event a Party fails to make payment as required pursuant
to this Section 4.2.5, amounts due may be offset against any which are payable
to such Party hereunder; provided, however, amounts being contested in good
faith pursuant to appropriate proceedings hereunder will not be subject to
offset.

 

4.2.6.                                                  Cost Overruns. If a
Party’s aggregate Development Expenses and Commercialization Expenses in any
Year are likely to exceed or exceed those set forth in the Development Budget or
Commercialization Budget for all of its activities under the Development Plan or
Commercialization Plan in such Year by up to [**], such Party shall provide to
the other Party an explanation for such excess costs and expenses, and such
excess costs and expenses shall be included in Program Expenses. Such Party will
be solely responsible for any amounts spent in excess of the Development Budget
or Commercialization Budget that are not included in Program Expenses pursuant
to this Section 4.2.6.  For the avoidance of doubt, to the extent a Party’s
aggregate Development Expenses or Commercialization Expenses exceed those set
forth in the Development Budget or Commercialization Budget by more than [**],
such Development Expenses or Commercialization Expenses will not be included in
Program Expenses.

 

4.3.                                              Records and Audits. During the
Term, each Party and its Affiliates will keep and maintain accurate and complete
records showing Net Sales made and expenses incurred by it in performing its
activities under the Development Plan and the Commercialization Plan during the
three preceding Years, which books and records will be sufficiently detailed
such that Program Expenses, Net Profits and Net Losses can accurately be
determined and each Party’s financial reporting obligations, independent auditor
requirements and obligations under the Sarbanes-Oxley Act can be satisfied. Upon
15 days’ prior written notice from a Party (the “Auditing Party”), the other
Party (the “Audited Party”) will permit an independent certified public
accounting firm of internationally recognized standing, selected by the Auditing
Party and reasonably acceptable to the Audited Party, to examine the relevant
books and records of the Audited Party and its Affiliates as may be reasonably
necessary to verify any Summary Statement submitted by the Audited Party in
accordance with Section 4.2.3 and the accuracy of the Reconciliation Report
prepared in accordance with Section 4.2.5. An examination by a Party under this
Section 4.3 will occur not more than once in any Year and will be limited to the
pertinent books and records for any Year ending not more than 36 months before
the date of the request. The accounting firm will be provided access to such
books and records at the Audited Party’s facility where such books and records
are normally kept and such examination will be conducted during the Audited
Party’s normal business hours. The Audited Party may require the accounting firm
to sign a standard non-disclosure agreement before providing the accounting firm
access to the Audited Party’s facilities or records. Upon completion of the
audit, the accounting firm will provide both Ironwood and AstraZeneca a written
report disclosing whether the reports submitted by the Audited Party are correct
or incorrect and the specific details concerning any discrepancies. No other
information will be provided to the Auditing

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Party. If the accountant determines that, based on errors in the reports so
submitted, the Reconciliation Report is incorrect, the Parties will promptly
revise the Reconciliation Report and any additional amount owed by one Party to
the other will be paid within 30 days after receipt of the accountant’s report,
along with interest at the annual interest rate as provided in Section 4.8,
compounded monthly from the date of the audit report; provided, however, that no
such interest will be payable if the errors leading to the Reconciliation Report
being incorrect were in the Summary Statement provided by the Party entitled to
receive such additional amount. If the accountant determines that a Summary
Statement submitted by the Audited Party overstates or understates the Audited
Party’s expenses by more than ten percent, the Party responsible for such
understatement or overstatement, as applicable, will reimburse the other Party
for the expenses incurred by the other Party in conducting the audit.

 

4.4.                                              Taxes and Withholding.

 

4.4.1.                                                  Taxes. The royalties,
milestones and other amounts payable by AstraZeneca to Ironwood pursuant to this
Agreement (“Payments”) shall not be reduced on account of any Taxes unless
required by Applicable Law. Ironwood alone shall be responsible for paying any
and all Taxes (other than withholding taxes required by Applicable Law to be
paid by AstraZeneca) levied on account of, or measured in whole or in part by
reference to, any Payments it receives.

 

4.4.2.                                                  Withholding. AstraZeneca
shall deduct or withhold from the Payments any Taxes that it is required by
Applicable Law to deduct or withhold. Notwithstanding the foregoing, if Ironwood
is entitled under any applicable treaty to a reduction of rate of, or the
elimination of, applicable withholding tax, it may deliver to AstraZeneca or the
appropriate governmental authority (with the assistance of AstraZeneca to the
extent that this is reasonably required and is expressly requested in writing)
the prescribed forms necessary to reduce the applicable rate of withholding or
to relieve AstraZeneca of its obligation to withhold Tax, and AstraZeneca shall
apply the reduced rate of withholding, or dispense with withholding, as the case
may be, provided that AstraZeneca has received evidence, in a form satisfactory
to AstraZeneca, of Ironwood’s delivery of all applicable forms (and, if
necessary, its receipt of appropriate governmental authorization) at least 15
days prior to the time that the Payments are due. If, in accordance with the
foregoing, AstraZeneca withholds any amount, it shall pay to Ironwood the
balance when due, make timely payment to the proper Tax Authority of the
withheld amount, and send to Ironwood proof of such payment within 60 days
following that payment. For purposes of this Agreement, the stated amount of the
Payments payable by AstraZeneca shall include any Indirect Tax that Ironwood may
be required to collect.

 

4.4.3.                                                  Indirect Taxes. All
Payments are exclusive of Indirect Taxes. If any Indirect Taxes are chargeable
in respect of any Payments, the paying Party shall pay such Indirect Taxes at
the applicable rate in respect of such Payments

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

following receipt, where applicable, of an Indirect Taxes invoice in the
appropriate form issued by the receiving Party in respect of those Payments. The
Parties shall issue invoices for all amounts payable under this Agreement
consistent with Indirect Tax requirements and irrespective of whether the sums
may be netted for settlement purposes. If such amounts of Indirect Taxes are
refunded by the applicable Governmental Authority or other fiscal authority
subsequent to payment, the Party receiving such refund will transfer such amount
to the paying Party within 45 days of receipt.

 

4.4.4.                                                  Imports. For the
avoidance of doubt, the Parties acknowledge and agree that none of the Payments
under this Agreement are related to the license (or right) to import or any
import of Products. The Parties shall cooperate to ensure that the Party
responsible for shipping values clinical Product in accordance with Applicable
Law and maximizes the full benefits of available duty free or savings programs
such as free trade agreements or other special programs and minimizes where
permissible any such duties and any related import taxes that are not
reclaimable from the relevant authorities. The receiving Party shall be
responsible for any import clearance, including payment of any import duties and
similar charges, in connection with any Products transferred to such Party under
this Agreement.

 

4.5.                                              Currency.  All amounts payable
and calculations hereunder will be in United States dollars. Net Sales recorded
in any foreign currency shall be converted into United States dollars in a
manner consistent with AstraZeneca’s customary and usual conversion procedures
used to prepare its audited financial statements for external reporting
purposes, provided that such practices use a widely accepted source of published
exchange rates. 

 

4.6.                                              Country of Payments.  All
amounts owed to a Party under this Agreement will be paid by the owing Party by
wire transfer of immediately available funds to an account designated by the
owed Party (which account may be updated by such owed Party from time to time in
writing). All such payments made by AstraZeneca to Ironwood will be made [**].

 

4.7.                                              Confidentiality. All financial
information of a Party which is subject to review under this Article 4 will be
deemed to be Confidential Information subject to the provisions of Section 5.1,
and such Confidential Information will not be disclosed to any Third Party or
used for any purpose other than verifying payments to be made by one Party to
the other hereunder; provided, however, that such Confidential Information may
be disclosed to Third Parties only to the extent necessary to enforce a Party’s
rights under this Agreement.

 

4.8.                                              Interest. Any payment under
this Article 4 that is more than [**] past due will be subject to interest at an
annual percentage rate of [**] (as published in the “Money Rates” table of the
Eastern Edition of The Wall Street Journal during the period such amount is
overdue) [**] if a Party does not make payment within [**] of its receipt of
notice that such amount is past due. Likewise, any overpayment that is

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

not refunded within [**] after the date such overpayment was made will
thereafter be subject to interest at an annual percentage rate of [**] (as
published in the “Money Rates” table of the Eastern Edition of The Wall Street
Journal during period such amount is overdue) [**]; provided, however, that if
the overpayment is due to errors in reports provided by the overpaid Party, such
interest will accrue from the date the overpayment was made. Notwithstanding the
preceding, if a Party contests any amounts due hereunder in good faith and
promptly notifies the other Party of such dispute, interest will not accrue as
to amounts being so contested until [**] following the presentation of such
notice to the other Party.

 

5.                                      COVENANTS

 

5.1.                                              Confidentiality.

 

5.1.1.                                                  Confidential
Information. Except to the extent expressly permitted by this Agreement and
subject to the provisions of Sections 5.1.2 and 5.1.3, at all times during the
Term and for [**] years following the expiration or termination of this
Agreement, each Party (a “Receiving Party”) (a) will keep completely
confidential and will not publish or otherwise disclose any Confidential
Information furnished to it by the other Party (a “Disclosing Party”), except to
those of the Receiving Party’s employees, Affiliates, consultants or
representatives who have a need to know such information (collectively,
“Authorized Recipients”) to perform such Party’s obligations hereunder or to
potential Sublicensees under an obligation of confidentiality no less protective
than the terms hereof, and (b) will not use Confidential Information of the
Disclosing Party directly or indirectly for any purpose other than exercising
its rights and performing its obligations hereunder. The Receiving Party will be
liable for any breach by any of its Authorized Recipients of the restrictions
set forth in this Agreement. Each Party will be deemed the Receiving Party with
respect to any Development Plan, Commercialization Plan, Joint Know-How or
Development Data, regardless of which Party has disclosed such Confidential
Information.

 

5.1.2.                                                  Exceptions to
Confidentiality. The Receiving Party’s obligations set forth in this Agreement
will not extend to any Confidential Information of the Disclosing Party:

 

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

 

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

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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

 

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

 

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

 

5.1.3.                                                  Authorized Disclosure.

 

(a)                                 Each Party and its Authorized Recipients may
disclose Confidential Information received from the other Party to the extent
that such disclosure is:

 

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

 

(ii)                                  made by a Party or its Affiliates, or
Sublicensees to a Regulatory  Authority as may be necessary or useful in
connection with any filing, application or request for a Regulatory Approval;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information, to the extent such protection is
available;

 

(iii)                               made by a Party to a patent authority as may
be necessary or useful for purposes of obtaining or enforcing a Patent Right
(consistent with the terms and conditions of Article 7); provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information, to the extent such protection is available;

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(iv)                              otherwise required by law; provided, however,
that if either Party is required to disclose Confidential Information of the
other Party, the Party required to make the disclosure shall (A) provide to the
other Party reasonable advance notice of and an opportunity to comment on any
such required disclosure, (B) if requested by the other Party, seek confidential
treatment with respect to any such disclosure to the extent available, and
(C) use good faith efforts to incorporate the comments of the other Party in any
such disclosure or request for confidential treatment; or

 

(v)                                 made by either Party to Third Parties under
confidentiality obligations no less protective than the obligations set forth
herein as may be necessary or useful in connection with the Development,
Commercialization, or Manufacture of the Licensed Compound or Products as
contemplated by this Agreement, including subcontracting or sublicensing
transactions in connection therewith.

 

(b)                                 Notwithstanding the provisions of this
Section 5.1, Ironwood may disclose AstraZeneca’s Confidential Information to
(i) Forest, Almirall, Astellas and any future licensees of the Licensed Compound
or Product in connection with the development, manufacture and commercialization
of the Licensed Compound or Product outside of the Territory or outside of the
Field in the Territory to the extent required under agreements with such parties
and provide such Third Parties with copies of all Regulatory Submissions in the
Territory, and (ii) a Revenue Buyer or bona fide potential Revenue Buyer as
reasonably necessary in connection with a Monetization Transaction or proposed
Monetization Transaction, provided that in the case of clause (ii) such
receiving Person is not engaged in the business of developing or commercializing
pharmaceutical products, in which case such disclosure shall be limited to
(A) financial reports indicating the amounts that are the subject of the
Monetization Transaction, (B) audit reports related to such amounts, if any, and
(C) notices and other correspondence provided under or relating to the subject
matter of this Agreement, in each case in clause (C) that are relevant to the
Monetization Transaction, provided further that, in each case ((i) and (ii)),
each recipient of such Confidential Information shall be under an obligation of
confidentiality no less protective than the terms of this Agreement. For
clarity, the disclosure of the terms of this Agreement are covered by
Section 5.1.6 and not this Section 5.1.3(b).

 

5.1.4.                                                  Notification. The
Receiving Party will notify the Disclosing Party immediately, and cooperate with
the Disclosing Party as the Disclosing Party may reasonably request, upon the
Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s
Confidential Information.

 

5.1.5.                                                  Destruction of
Confidential Information. Upon the expiration or earlier termination of this
Agreement, except to the extent necessary or useful

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

to exercise rights or perform obligations that continue after such expiration or
termination, and except as otherwise provided in Section 8.5, the Receiving
Party will (a) destroy all tangible embodiments of Confidential Information of
the Disclosing Party, including any and all copies thereof, and those portions
of any documents, memoranda, notes, studies, and analyses prepared by the
Receiving Party or its Authorized Recipients that contain, incorporate, or are
derived from such Confidential Information and provide written certification of
such destruction to the Disclosing Party in a form reasonably acceptable to the
Disclosing Party, provided that the legal department of the Receiving Party will
have the right to retain one copy of any such tangible embodiments for archival
purposes, provided such copy will continue to be maintained on a confidential
basis subject to the terms of this Agreement, and (b) immediately cease, and
will cause its Authorized Recipients to cease, use of such Confidential
Information as well as any information or materials that contain, incorporate,
or are derived from such Confidential Information.

 

5.1.6.                                                  Use of Name and
Disclosure of Terms. Except as permitted under Section 10.14, each Party will
and will cause its Affiliates to (a) keep the existence of, the terms of, and
the transactions covered by this Agreement confidential and (b) not disclose
such information to any other Third Party through a press release or otherwise,
and, except as otherwise permitted hereunder, will not mention or otherwise use
the name, insignia, symbol, trademark, trade name, or logotype of the other
Party or its Affiliates in any manner without the prior written consent of the
other Party in each instance (which will not be unreasonably withheld,
conditioned or delayed). The restrictions imposed by this Section 5.1.6 will not
prohibit either Party or its Affiliates from making any disclosure that is
required by Applicable Law, rule, or regulation or the requirements of a
national securities exchange or another similar regulatory body including
disclosing such information in any clinical trial database maintained by or on
behalf of a Party. In addition, in connection with a specific transaction or
proposed transaction, including, with respect to Ironwood, a Monetization
Transaction, either Party may disclose the terms of this Agreement to the
counter party to such transaction if such counter party is a bona fide potential
investor, underwriter, lender or Revenue Buyer; provided that (i) such
disclosure shall be under provisions of confidentiality no less protective than
the terms of this Agreement, (ii) the disclosure is reasonably necessary in
light of the contemplated transaction and (iii) the receiving Person is not
engaged in the business of developing or commercializing pharmaceutical
products. Further, the restrictions imposed on each Party under this
Section 5.1.6 are not intended, and will not be construed, to prohibit a Party
or is Affiliates from identifying the other Party or its Affiliates in its
internal business communications, provided that any Confidential Information in
such communications remains subject to this Section 5.1.6.  In the event that
either Party is required by Applicable Law or the requirements of a national
securities exchange or another similar regulatory body to disclose this
Agreement, in whole or in part, the Parties will cooperate in preparing a
redacted version of this Agreement and consider any comments received from the
other Party with

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

respect thereto in good faith, provided that the Party subject to such
requirement shall have final decision-making authority with respect to the
contents of such redacted version of this Agreement.

 

5.1.7.                                                  Remedies. The Parties
acknowledge and agree that the restrictions set forth in this Section 5.1 are
reasonable and necessary to protect the legitimate interests of the Parties and
that neither Party would have entered into this Agreement in the absence of such
restrictions, and that any breach or threatened breach of any provision of this
Section 5.1 will result in irreparable injury to the other Party for which there
will be no adequate remedy at law. Notwithstanding the dispute resolution
mechanism agreed to by the Parties in Section 10.1, in the event of a breach or
threatened breach of any provision of Section 5.1 by a Party, the other Party
will be authorized and entitled to obtain from any court of competent
jurisdiction, applying the laws of that court, injunctive relief, whether
preliminary or permanent, specific performance and an equitable accounting of
all earnings, profits and other benefits arising from such breach, which rights
will be cumulative and in addition to any other rights or remedies to which such
Party may be entitled in law or equity. The breaching Party agrees to waive any
requirement that the non-breaching Party (a) post a bond or other security as a
condition for obtaining any such relief and (b) show irreparable harm, balancing
of harms, consideration of the public interest or inadequacy of monetary damages
as a remedy. Nothing in this Section 5.1.7 is intended, or will be construed, to
limit the Parties’ rights to equitable relief or any other remedy for a breach
of any provision of this Agreement.

 

5.2.                                              Restrictions.

 

5.2.1.                                                  On AstraZeneca. During
the period commencing [**], neither AstraZeneca nor any of its Affiliates [**].

 

5.2.2.                                                  Reciprocal Non-Compete
Provisions.

 

(a)                                 [**], neither Party, nor any of their
respective Affiliates will [**].

 

(b)                                 Without limitation of Section 5.2.2(a),
during the period [**], neither Party nor any of their respective Affiliates
will [**].

 

(c)                                  Notwithstanding the provisions of Sections
5.2.2(a) and 5.2.2(b), if a Party or any of its Affiliates [**].

 

5.3.                                              [**].

 

5.4.                                              Compliance with Law. Each
Party hereby covenants to comply with all Applicable Law and industry
professional standards applicable to its activities connected with the
Development, Manufacture, and Commercialization (as applicable) of Products.
Without limiting the generality of the foregoing:

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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

 

5.4.2.                                                  Debarment. Each Party
will not use in any capacity, in connection with the activities to be performed
under this Agreement, any person who has been debarred pursuant to Section 306
of the United States Federal Food, Drug, and Cosmetic Act or analogous law, or
who is the subject of a conviction described in such section or a corresponding
section of any analogous law. Each Party will inform the other Party in writing
immediately if it or any person who is performing or has performed activities
hereunder or is conducting or has conducted any development of the Licensed
Compound or Product is debarred or is the subject of a conviction described in
Section 306 or a corresponding section of any analogous law, or if any action,
suit, claim, investigation or legal or administrative proceeding is pending
relating to the debarment or conviction of such Party or any person performing
services hereunder.

 

5.5.                                              Business Ethics.

 

5.5.1.                                                  Each Party will conduct
its business in accordance with Applicable Law. By signing this Agreement, each
Party agrees to conduct its activities under this Agreement in a manner that is
consistent with Applicable Law, including the U.S. Foreign Corrupt Practices
Act, the UK Bribery Act 2010, and the relevant provisions of the People’s
Republic of China Criminal Law and People’s Republic of China Anti-Unfair
Competition Law, each as amended, and any other applicable anti-corruption laws
and laws for the prevention of fraud, racketeering, or money laundering
(collectively, “Anti-Corruption Laws”).

 

5.5.2.                                                  Each Party will not,
directly or indirectly, pay, offer or promise to pay, or authorize the payment
of any money, or give, offer or promise to give, or authorize the giving of
anything of value (collectively, a “Prohibited Payment”) to any government or
political party officials, officials of international public organizations,
candidates for public office or representatives of other businesses or persons
acting on behalf of any of the foregoing (collectively, “Officials”) where such
Prohibited Payment would constitute a violation of any Anti-Corruption Law. In
addition, regardless of legality, each Party will make no Prohibited Payment,
directly or indirectly, to any Official if such Prohibited Payment is for the
purpose of influencing decisions or actions with respect to the subject matter
of this Agreement or any other aspect of the other Party’s business. Each Party
acknowledges and agrees that none of it, or any of its Affiliates or its or
their respective officers, directors, employees, agents and representatives
(collectively, “Authorized

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Representatives”) is authorized to waive compliance with the provisions of this
Section 5.5 and that each Party will be solely responsible for its compliance
with the provisions of this Section 5.5 and the Anti-Corruption Laws
irrespective of any act or omission of the other Party or any of its Affiliates,
Sublicensees or its or their respective Authorized Representatives. Each Party’s
failure to abide by the provisions of this Section 5.5 shall be deemed a
material breach of this Agreement and without prejudice to any other rights or
remedies that may be available to the non-breaching Party under this Agreement
or in law or equity, then the consequences in Section 3.9 will apply.

 

5.6.                                              Standstill Agreement.  [**]
neither AstraZeneca nor any of its controlled Affiliates or its Affiliates under
common control (collectively the “AstraZeneca Related Parties”) will, in any
manner, directly or indirectly, do the following unless requested by Ironwood,
except in connection with the transactions contemplated by this Agreement:

 

(a)                                 make, effect, initiate, directly participate
in or cause

 

(i)                                     any acquisition of beneficial ownership
of any voting securities of Ironwood, if, after such acquisition, the
AstraZeneca Related Parties would beneficially own more than ten percent of the
outstanding common stock of Ironwood provided that the AstraZeneca Related
Parties may own an amount in excess of such percentage to the extent resulting
exclusively from actions taken by Ironwood or its Affiliates;

 

(ii)                                  any acquisition of all or substantially
all of the assets of Ironwood; provided this subsection (ii) will not apply to
the acquisition by the AstraZeneca Related Parties of a license or other rights
to Ironwood assets or technology under terms negotiated by the Parties;

 

(iii)                               any tender offer, exchange offer, merger,
business combination, recapitalization, restructuring, liquidation, dissolution
or extraordinary transaction involving Ironwood, or involving any voting
securities or material portion of the assets of Ironwood (except as otherwise
permitted hereunder); provided that this subsection (iii) will not apply to such
a transaction by the AstraZeneca Related Parties involving a license or other
rights to Ironwood assets or technology under terms negotiated by the Parties;
or

 

(iv)                              any “solicitation” of “proxies” (as those
terms are used in the proxy rules of the Securities and Exchange Commission) or
consents with respect to any voting securities of Ironwood;

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(b)                                 form, join or participate in a Group with
respect to the beneficial ownership of any voting securities of Ironwood;

 

(c)                                  act, alone or in concert with others, to
seek to control the management, board of directors or policies  (except as they
related to the activities under this Agreement) of Ironwood;

 

(d)                                 take any action that might require Ironwood
to make a public announcement regarding any of the types of matters set forth in
Section 5.6(a)(i);

 

(e)                                  enter into any agreement with any other
person relating to any of the foregoing; or

 

(f)                                   publicly request or propose that Ironwood
amend, waive or consider the amendment or waiver of any provision set forth in
this Section 5.6.

 

Notwithstanding the foregoing, the provisions of this Section 5.6 will not apply
to (i) the exercise by any of the AstraZeneca Related Parties of any rights
available to shareholders generally pursuant to any transaction described in
Section 5.6(a) above, provided that such AstraZeneca Related Party has not then
either directly or as a member of a Group made, effected, initiated or caused
such transaction to occur,  (ii) the acquisition of, or offering to acquire,
directly or indirectly, any, company or business unit (other than Ironwood) that
beneficially owns Ironwood voting securities so long as such company or business
unit’s acquisition of Ironwood’s securities was not made on AstraZeneca’s
behalf, provided that although the AstraZeneca Related Parties shall not be
required to divest the holdings of Ironwood’s securities by such company or
business unit upon acquisition thereof, such holdings when aggregated with the
then-existing holdings of Ironwood securities of the AstraZeneca Related Parties
may prevent the AstraZeneca Related Parties, pursuant to the terms of
Section 5.6(a)(i), from acquiring additional Ironwood securities, (iii) the
making of any non-public proposal, or entering into any commercial transaction
with respect to, or otherwise consummating, any commercial transaction in the
ordinary course of the business or the Parties’ ongoing business relationships
or (iv) any activity by any of the AstraZeneca Related Parties after
(1) Ironwood has made any public announcement of its intent to solicit or engage
in any transaction of the type  which if consummated would constitute a
Combination, (2) Ironwood enters into an agreement or an agreement in principle
providing for a Combination or Ironwood redeems any rights under or modifies or
agrees to modify a shareholder rights plan to facilitate any specific
Combination, or (3) a tender or exchange offer which if consummated would
constitute a Combination is made and the Board of Directors of Ironwood either
accepts such offer or fails to recommend that its stockholders reject such offer
within ten business days from the date of commencement of such offer, provided,
however, that, the provisions of this Section 5.6 will again be applicable, in
each case, (y) if Ironwood terminates such

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

transaction (if entered into previously) or announces its intent to terminate
such transaction (if only an announcement has then been made), withdraws such
recommendation or rejects such offer, each as applicable, and (z) (A) such
AstraZeneca Related Party has not previously made any public announcement of its
intent to solicit or engaged in any transaction of the type referred to in
Section 5.6(a) above, or (B) in the event that such public announcement has been
made by any of the AstraZeneca Related Parties, such AstraZeneca Related Party
has terminated or announced its intent to terminate such transaction.

 

“Group” means two or more Persons acting as a partnership, limited partnership,
syndicate or other group for the purpose of acquiring, holding or disposing of
securities of Ironwood. A “Combination” means a transaction in which (1) a
Person or Group acquires, directly or indirectly, securities representing 50% or
more of the voting power of the outstanding securities of Ironwood or properties
or assets constituting 50% or more of the consolidated assets of Ironwood and
its subsidiaries or (2) in any case not covered by (1), (x) Ironwood issues
securities representing 50% or more of its total voting power, including the
case of (1) and (2) by way of a merger or other business combination with
Ironwood or any of its subsidiaries or (y) Ironwood engages in a merger or other
business combination such that the holders of voting securities of Ironwood
immediately prior to the transaction do not own more than 50% of the voting
power of securities of the resulting entity.

 

Ironwood [**].

 

Nothing in this Section 5.6 shall preclude discussions or communications of any
kind between AstraZeneca and its Affiliates.

 

5.7.                                              Enforcement of Infringing or
Counterfeit Goods. AstraZeneca will use Commercially Reasonable Efforts to
(a) monitor commercial markets in the Territory for incidences of sales of
counterfeit goods or uses of Trademarks, including trade dress, that infringe
the Product Trademarks or Product Domain Names, including Product trade dress
that may cover, compete with, or damage sales of the Product and other similar
offenses (collectively, “Counterfeiting”) in accordance with the procedures
established by the IPWG and (b) stop all such Counterfeiting using all
Commercially Reasonable measures available under Applicable Law. AstraZeneca
will promptly notify Ironwood of any incidence of Counterfeiting in the
Territory of which it becomes aware and will coordinate with and keep Ironwood
apprised of any efforts to stop such Counterfeiting. Ironwood will cooperate
with AstraZeneca as reasonably requested by AstraZeneca with respect to the
foregoing matters and will use Commercially Reasonable Efforts to enforce any
analogous provisions in the Existing Agreements to the extent likely to impact
the Territory. Costs incurred under this Section 5.7 [**].

 

5.8.                                              Development Data. AstraZeneca
will not use any Development Data in connection with the development,
manufacture or commercialization of any GC-C Agonist anywhere in the world other
than the Licensed Compound and Products in

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

accordance with this Agreement, unless (a) AstraZeneca is exercising
(sub)licensed rights to the Development Data under an Existing License Agreement
(or other separate license agreement under which Ironwood grants rights to use
the Development Data in the applicable jurisdiction), or (b) such Development
Data becomes part of the public domain though no wrongful act, fault or
negligence on the part of AstraZeneca, its Affiliates or Sublicensees.

 

5.9.                                              Export Restrictions.
AstraZeneca will not knowingly sell, export, or distribute, directly or
indirectly, any Product to any location outside of the Territory or take any
action that AstraZeneca reasonably believes will result in such export. Ironwood
will not knowingly sell, export, or distribute, or permit any Third Party to do
any of the foregoing, directly or indirectly (including through Forest), any
Product or the Licensed Compound to any location within the Territory that is
intended to be the final location for sale, export or distribution of such
Product or Licensed Compound or take any action that Ironwood reasonably
believes would result in any of the foregoing (except for the supply of Licensed
Compound and Product to AstraZeneca pursuant to the terms and conditions of this
Agreement and the Supply Agreement).

 

5.10.                                       Existing Agreements. Ironwood
covenants the following relating to the Existing Agreements, except as would not
materially adversely affect any of AstraZeneca’s rights or obligations under
this Agreement: (a) Ironwood will not and will cause its Affiliates to not make
any amendments or modifications with respect to, or provide any consents or
waivers or enter into any side letter relating to any of the Existing Agreements
without AstraZeneca’s prior written consent; (b) Ironwood will use Commercially
Reasonable Efforts to ensure (i) the performance of any acts contemplated in
this Agreement to be undertaken by Forest, Astellas, or Almirall and
(ii) compliance by Forest, Astellas, and Almirall with any corresponding
obligations of Forest, Astellas, or Almirall under the Forest Agreement,
Astellas Agreement, and Almirall Agreement, as applicable; and (c) Ironwood will
not breach (i) any material provisions of any agreements with Third Parties
relating to the Ironwood Patent Rights or Ironwood Know-How or (ii) any of the
Existing Agreements.

 

5.11.                                       Other Linaclotide Partners. [**]

 

5.12.                                       [**]

 

6.                                      REPRESENTATIONS AND WARRANTIES

 

6.1.                                              Representations and Warranties
of Each Party. As of the Effective Date, each of AstraZeneca and Ironwood hereby
represents and warrants to the other Party hereto as follows:

 

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

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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

 

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

 

(d)                                 the execution, delivery and performance by
such Party of this Agreement and its compliance with the terms and provisions do
not and will not conflict with or result in a breach of any of the terms and
provisions of or constitute a default under (i) any agreement to which it or its
Affiliates is a party, (ii) the provisions of its charter or operative documents
or bylaws or (iii) any order, writ, injunction or decree of any court or
governmental authority entered against it or by which any of its property is
bound;

 

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

 

(f)                                   it and its Affiliates have not violated in
any manner that is reasonably likely to affect the rights of the other Party
hereunder or adversely affect the Development, or Commercialization of any
Product hereunder, any laws, rules, regulations, or any order of any applicable
supranational, national, federal, state, provincial, and local governmental
entities, in each case, concerning the confidentiality or protection of patient
identifiable information or patients’ protected health information, as defined
by any applicable legislation.

 

6.2.                                              Additional Representations,
Warranties and Covenants of Ironwood. Ironwood hereby represents, warrants and
covenants to AstraZeneca that as of the Effective Date:

 

(a)                                 Ironwood has with respect to any Patent
Right that has reached the nationalization stage as of the Effective Date and
will have at the time of nationalization of any other Patent Right, in each
case, in the Territory, the sole and exclusive right in the Territory in and to
the Ironwood Patent Rights listed in Schedule 6.2(a) attached hereto and the
ownership of such Ironwood Patent Rights is as set forth on such Schedule
6.2(a). Ironwood has the sole and exclusive rights in the Territory with respect
to all Ironwood Know-How that it purports to grant to AstraZeneca hereunder, in
each case free of any encumbrance, lien, or claim of ownership by any Third
Party.

 

(b)                                 Ironwood is not subject to any agreement
with a Third Party that includes a royalty or similar payment obligation to, or
other restriction or limitation in favor of, such Third Party (including, for
this purpose, to

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

current or former officers, directors, employees, consultants or personnel of
Ironwood or any predecessor) with respect to (i) its rights to practice the
Ironwood Technology in the Territory or (ii) the Development or
Commercialization of the Licensed Compound or any Product in the Territory.

 

(c)                                  To Ironwood’s and its Affiliates’ knowledge
[**], no Person is infringing or threatening to infringe or misappropriating or
threatening to misappropriate the Ironwood Patent Rights or the Ironwood
Know-How.

 

(d)                                 To Ironwood’s and its Affiliates’ knowledge,
the conception, development, and reduction to practice of the Ironwood Patent
Rights and Ironwood Know-How existing as of the Effective Date have not
constituted or involved the misappropriation of trade secrets or other rights or
property of any Person.

 

(e)                                  No Ironwood Patent Rights are subject to,
or were developed pursuant to any funding agreement with any government or
government agency.

 

(f)                                   Ironwood is not in material breach of any
provisions of any agreements with Third Parties relating to the Ironwood Patent
Rights or Ironwood Know-How and is not in material breach of any of the Existing
Agreements, in each case, in a manner that is reasonably likely to affect the
rights of the other Party hereunder or adversely affect the Development, or
Commercialization of any Product hereunder.

 

(g)                                  Ironwood has not received any written or
oral claim of ownership, inventorship or patent infringement from any Third
Party (including by current or former officers, directors, employees,
consultants, or personnel of Ironwood or any predecessor) with respect to the
Ironwood Technology, and Ironwood is not aware of any reasonable basis for any
such claim.

 

(h)                                 Except [**], no claim or litigation has been
brought or threatened by any Person alleging, and Ironwood is not aware, that
any of the Ironwood Patent Rights or the Ironwood Know-How are invalid or
unenforceable.

 

(i)                                     To Ironwood’s and its Affiliates’
knowledge, the manufacture, use or sale of the Product in the Territory for the
indications set forth in the Initial Development Plans will not infringe any
issued claim of an issued patent right of any Third Party, other than Patent
Rights that Ironwood Controls.

 

(j)                                    Ironwood has made available to
AstraZeneca all material Regulatory Approvals and Regulatory Submissions,
including the Referenced Regulatory Filings and Ironwood Know-How, in each case,
in its Control regarding or related to any Licensed Compound or Product,

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

including to its and its Affiliates’ knowledge, all of the foregoing, in each
case, that are necessary to allow Ironwood and AstraZeneca to file for initial
Regulatory Approvals in the Field in the Territory as contemplated hereunder,
other than those activities contemplated by the Development Plans and
Commercialization Plans. Ironwood has made available to AstraZeneca all
Regulatory Approvals and Regulatory Submissions, including the Referenced
Regulatory Filings and Ironwood Know-How in its Control regarding or related to
any Licensed Compound or Product and all such Regulatory Approvals, Regulatory
Submissions, Referenced Regulatory Filings and Ironwood Know-How are true and
complete.  As of the Effective Date, Ironwood has prepared, maintained and
retained all Regulatory Approvals and Regulatory Submissions pursuant to and in
accordance with GCP and good laboratory practices, as applicable, and Applicable
Law and all such information is and will be true and complete.

 

(k)                                 Material trade secrets comprising the
Ironwood Know-How have been kept confidential or have been disclosed to Third
Parties only under terms of confidentiality.  To Ironwood’s and its Affiliates’
knowledge, no breach of such confidentiality with respect to such Know-How has
been committed by any Third Party.

 

(l)                                     Ironwood Controls, as of the Effective
Date, and will maintain Control of, such Know-How, and Patent Rights that have
arisen or may arise under the Existing Agreements as are required to the extent
necessary for AstraZeneca to perform its obligations and exercise its rights
under this Agreement, including to conduct the Development activities with
respect to the Licensed Compound and Product(s) in the Field in the Territory
contemplated in the Initial Development Plan.

 

(m)                             To Ironwood’s and its Affiliates’ knowledge, it
has conducted any Development and Commercialization activities in accordance
with good laboratory and clinical practice and Applicable Law.

 

(n)                                 To Ironwood’s and its Affiliates’ knowledge,
neither Ironwood nor any of its Affiliates, nor any of its or their respective
officers, employees, or agents has made an untrue statement of material fact or
fraudulent statement to any Regulatory Authority with respect to the Development
of the Licensed Compound or the Products, failed to disclose a material fact
required to be disclosed to any Regulatory Authority with respect to the
Development of the Licensed Compound or the Products, or committed an act, made
a statement, or failed to make a statement with respect to the Development of
the Licensed Compound or the Products that could reasonably be expected to
provide a basis for the United States Food and Drug Administration to invoke its
policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and
any amendments thereto or any analogous laws or policies in the Territory.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(o)                                 Neither Ironwood nor any of its Affiliates
has been debarred or is subject to debarment and neither Ironwood nor any of its
Affiliates has used in any capacity, in connection with the Ironwood Technology,
the Licensed Compound or the Products, any Person who has been debarred pursuant
to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, or who
is the subject of a conviction described in such section.

 

(p)                                 The countries comprising Astellas’ territory
under the Astellas Agreement are the same as those existing as of the effective
date of the Astellas Agreement[**].

 

(q)                                 To Ironwood’s and its Affiliates’ knowledge,
it and its Affiliates have not violated any material Anti-Corruption Laws with
respect to the Territory except for such matters as has been disclosed to
AstraZeneca prior to the Effective Date.

 

(r)                                    Ironwood has made available to
AstraZeneca for review in due diligence all material (i) clinical and
pre-clinical data relating to the Product(s) existing as of the Effective Date
that is contained in Regulatory Submissions for such Product(s) in the Field in
the Territory in its or any of its Affiliates’ possession, and (ii) Ironwood
Know-How that has been requested of Ironwood by AstraZeneca or, to Ironwood’s or
its Affiliates’ knowledge, is material to the Development or Commercialization
of the Product(s) hereunder. To Ironwood’s or its Affiliates’ knowledge, all
Ironwood Know-How that has been disclosed by Ironwood or its Affiliates to
AstraZeneca under this Agreement or in connection with such due diligence or the
negotiation of this Agreement is or will be true and correct in all material
aspects. All adverse information with respect to the safety and efficacy of the
Products known to Ironwood or its Affiliates as of the Effective Date has been
disclosed by Ironwood to AstraZeneca through such due diligence review.

 

6.3.                                              Additional Representations and
Warranties of AstraZeneca. AstraZeneca hereby represents, warrants and covenants
to Ironwood that as of the Effective Date:

 

(a)                                 AstraZeneca has no products [**].

 

(b)                                 To AstraZeneca’s knowledge, AstraZeneca and
its Affiliates have not materially violated any Anti-Corruption Laws with
respect to the Territory except for such matters as has been disclosed to
Ironwood prior to the Effective Date.

 

6.4.                                              Representation by Legal
Counsel. Each Party hereto represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has
participated in the drafting. In interpreting and applying the

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

terms and provisions of this Agreement, the Parties agree that no presumption
will exist or be implied against the Party which drafted such terms and
provisions.

 

6.5.                                              No Inconsistent Agreements.
Neither Party has in effect and after the Effective Date neither Party may enter
into any oral or written agreement or arrangement that would be inconsistent
with its obligations under this Agreement or limit the ability of either Party
to grant the licenses set forth in Article 2 of this Agreement.

 

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

 

7.                                      INTELLECTUAL PROPERTY

 

7.1.                                              Disclosure. During the Term,
the Parties will promptly disclose to one another all Collaboration Know-How
(whether patentable or not).

 

7.2.                                              Ownership.

 

7.2.1.                                                  Ownership of Technology.
Except as set forth in Section 7.2.2, determinations as to which Party has
invented any Patent Right or Know-How will be made in accordance with the
standards of inventorship under U.S. patent law. Subject to the license grants
under Article 2, as between the Parties, Ironwood will own all Ironwood
Technology (including any Collaboration Know-How (other than Joint Know-How and
Development Data) that is invented, conceived or developed solely by employees
of Ironwood or its Affiliates, or Third Parties acting on behalf of Ironwood or
its Affiliates, and any Patent Rights claiming such Collaboration Know-How) and
AstraZeneca will own all AstraZeneca Technology (including Collaboration
Know-How (other than Joint Know-How and Development Data) that is invented,
conceived, or developed solely by employees of AstraZeneca or its Affiliates, or
Third Parties acting on behalf of AstraZeneca or its Affiliates, and any Patent
Rights claiming such Collaboration Know-How).  Each Party will own an undivided
one-half interest in and to the Joint Technology. In the event inventorship and
ownership of any Collaboration Technology cannot be resolved by the Parties with
advice of their respective intellectual property counsel, such dispute will be
resolved through arbitration pursuant to Section 10.1.3, provided such
arbitration panel will include at least a single arbitrator who is a specialist
in U.S. chemical and pharmaceutical patent law

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

and in chemical and pharmaceutical patents. Each Party shall make such
assignments as are required to effect the ownership allocations set forth in
this Section 7.2.1. Subject to the licenses granted to the other Party under
this Agreement and the other terms of this Agreement, each Party has a right to
exploit its interest in the Joint Technology without the consent of and without
accounting to the other Party except, neither Party may assign its right, title,
or interest in the Joint Technology to any Person, except (a) in connection with
a permitted transaction under Section 10.9, or (b) to an Affiliate.

 

7.2.2.         Development Data. Each Party will own an undivided one-half
interest in and to all Development Data. Subject to the licenses granted to the
other Party under this Agreement, Section 5.8 and the other terms of this
Agreement, each Party has the right to exploit its interest in the Development
Data without consent of and without accounting to the other Party, except
neither Party may assign its right, title, or interest in the Development Data
to any Person, except (a) in connection with a permitted transaction under
Section 10.9, or (b) to an Affiliate.

 

7.2.3.         Employee Assignment. Each Party shall procure from each of its
employees and permitted assignees and subcontractors who are conducting work
under this Agreement, rights to any and all Ironwood Technology, AstraZeneca
Technology, Development Data or Joint Technology, as applicable, such that each
Party shall receive from the other Party, without payments beyond those
contemplated by this Agreement, the rights granted to such Party to use such
Ironwood Technology (in the case of Ironwood), AstraZeneca Technology (in the
case of AstraZeneca), Development Data or Joint Technology, as applicable,
pursuant to this Agreement. In the event such rights have not been secured or
any original holder challenges such procurement, the Party responsible for
procuring such rights [**].

 

7.3.               Intellectual Property Working Group.  The Parties will
promptly establish an intellectual property working group (“IPWG”) comprised of
at least one senior patent attorney and, as needed, one trademark attorney, from
each Party, together with research and development personnel and such other
representatives of the Parties as the Parties may determine to be appropriate
from time to time, to manage and review the patent strategy for Collaboration
Know-How to the extent such Collaboration Patent Rights are necessary or useful
in the Territory to Develop, Manufacture or Commercialize the Licensed Compound
or Product and perform such other activities as may be delegated to the IPWG
pursuant to this Agreement or by the Parties from time to time during the Term
by mutual written agreement. All decisions of the IPWG will be made by
consensus, with each Party’s representatives on the IPWG having collectively one
vote on all matters that are within the responsibility of the IPWG. In the event
that the IPWG adopts a patent strategy, the Parties shall comply with such
strategy in connection with the exercise of their rights under this Article 7.
If there is no such strategy, then the Party with the primary responsibility for
an activity under this Article 7 will be responsible for developing and
implementing the applicable strategy.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

7.4.               Prosecution and Maintenance of Patent Rights.

 

7.4.1.         Patent Prosecution and Maintenance. Ironwood will be responsible
for the preparation, filing, prosecution and maintenance of the Ironwood Patent
Rights, and AstraZeneca will have the first right, but not the obligation, to
prepare, file, prosecute and maintain the Collaboration Patent Rights included
in the AstraZeneca Patent Rights (the “AstraZeneca Collaboration Patent Rights”)
worldwide, each at their own expense except [**], and in each case, provided
that: in the case of the Ironwood Patent Rights and the AstraZeneca
Collaboration Patent Rights, each Party will provide the other with (a) advance
copies of, and a reasonable opportunity to comment upon, proposed patent filings
in the Territory (in the case of the Ironwood Patent Rights) and worldwide (in
the case of the AstraZeneca Collaboration Patent Rights) and prosecution
strategies and proposed correspondence with patent offices in the applicable
jurisdiction undertaken pursuant to any such filings, and will consider comments
received in good faith and will not unreasonably reject such comments, except
that Ironwood will not be obligated to provide AstraZeneca with advance copies
of proposed patent filings, related prosecution strategies or proposed
correspondence for any Patent Rights that are included in the rights granted by
Forest, Astellas or Almirall, as applicable, to Ironwood pursuant to any of the
Existing Agreements, unless it is permitted to do so thereunder; and
(b) correspondence or other communications or actions which relate to the
validity of Collaboration Patent Rights, to the extent such Collaboration Patent
Rights are necessary or useful in the Territory to Develop, Manufacture or
Commercialize a Licensed Compound or Product in the Territory, which
correspondence or other communications or actions that are to be made during the
course of an action before a national or regional patent office in the Territory
or national court in the Territory will require the mutual approval of both
Parties. A Party providing comments in accordance with this Section 7.4.1 will
provide such comments, if any, expeditiously and in any event in reasonably
sufficient time to meet any filing deadline communicated to it by the other
Party. The Party receiving any such patent application and correspondence will
maintain such information in confidence, except for patent applications that
have been published and official correspondence that is publicly available.

 

7.4.2.         Joint Patent Rights. Ironwood will have the first right, but not
the obligation for the preparation, filing, prosecution and maintenance of the
Joint Patent Rights. Except as otherwise agreed by the Parties in writing, costs
incurred under this Section 7.4.2 for Joint Patent Rights [**].

 

7.4.3.         Second Rights. If a Party decides not to file, prosecute or
maintain a Patent Right covering, as applicable, Ironwood Technology,
Collaboration Technology included in the AstraZeneca Technology or Joint
Technology, to the extent such Technology covers the Development, Manufacture or
Commercialization of the Licensed Compound or Product, with respect to Ironwood
Technology within the Territory and with respect to such

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

AstraZeneca Technology whether within or outside of the Territory, it will give
the other Party reasonable notice to that effect sufficiently in advance of any
deadline for any filing with respect to such Patent Right to permit the other
Party to carry out such activity. After such notice, the other Party may,
subject to the terms of any applicable license as a result of which a Party
Controls such Patent Rights (i.e., the Existing Agreements or other Third Party
agreements), file, prosecute and maintain the Patent Right, and perform such
acts as may be reasonably necessary for such other Party to file, prosecute or
maintain such Patent Right, at its sole cost and expense, except [**]. If such
other Party does so elect, then the Party which has elected not to pursue such
filing, prosecution or maintenance will provide such cooperation to the other
Party, including the execution and filing of appropriate instruments, as may
reasonably be requested to facilitate the transition of such patent activities,
and will assign all of its right, title and interest to such patent, other than
its license rights thereto provided by this Agreement, to the Party electing to
pursue such patent activities.

 

7.4.4.         Patent Term Extensions. Regardless of which Party is filing,
prosecuting and maintaining any Patent Right pursuant to this Article 7, the
Parties shall attempt to make all decisions by mutual consent regarding all
patent term extensions for (a) the Ironwood Patent Rights in the Territory,
(b) the AstraZeneca Collaboration Patent Rights in the Territory and (c) the
Joint Patent Rights worldwide, including, if applicable, in the United States
with respect to extensions pursuant to 35 U.S.C. § 156 et. seq. and in other
jurisdictions pursuant to supplementary protection certificates, and in all
jurisdictions with respect to any other extensions that are now or become
available in the future, wherever applicable, for such Patent Rights. If, with
respect to a Product and a country, the Parties cannot agree on which of such
Patent Rights(s) as to which the term is to be extended in such country, then
(i) with respect to such Patent Rights in the Territory, the Parties shall
mutually agree on a Third Party patent lawyer (whose costs [**]) and shall give
such lawyer instructions to resolve such disagreement in a manner designed to
maximize the period of exclusivity for the applicable Product, and the decision
of such lawyer shall be binding on the Parties and (ii) Ironwood will have the
right to make such decision outside the Territory for the Joint Patent Rights.
Upon request by a Party controlling a decision under this Section 7.4.4, the
other Party shall reasonably cooperate in the implementation of such decision.

 

7.5.               Trademarks and Domain Names.

 

7.5.1.         Product Trademark. Until such time as the Parties determine that
the launch by a Third Party of a generic equivalent of the Product is imminent
in the Territory (provided that discussion shall not be required if the JCC no
longer has jurisdiction with respect to the Territory, for example in the case
of Section 3.9) (based upon objective evidence shared and discussed by both
Parties), all Products are to be Commercialized in the Territory under those
Trademarks and using those domain names selected by the JCC, after good faith
consultation with the Parties’ intellectual property counsel (each such

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Trademark, other than AstraZeneca House Marks or Ironwood House Marks, a
“Product Trademark” and each such domain name, other than those containing a
AstraZeneca House Mark or Ironwood House Mark, a “Product Domain Name”). After
such time, AstraZeneca may select any Trademark or domain name of its choosing
for the Commercialization of the Products in the Territory. The Parties
acknowledge and agree that any Trademarks or domain names developed or used in
connection with the Existing Agreements may not be used by the Parties in the
Territory unless agreed to by Ironwood and Forest, Ironwood and Almirall, or
Ironwood and Astellas, as applicable, in writing. Ironwood shall notify
AstraZeneca of such restricted Trademarks and domain names so that AstraZeneca
is able to comply with this requirement.

 

7.5.2.         Ownership. Ironwood will own all Product Trademarks and Product
Domain Names, subject to the license granted to AstraZeneca herein, and is
responsible for the filing, prosecution, registration and maintenance of such
Product Trademarks and the registration and maintenance of such Product Domain
Names. If Ironwood decides not to file or continue to prosecute, register or
maintain a Product Trademark or obtain or maintain a Product Domain Name in the
Territory, it will give AstraZeneca reasonable notice to that effect
sufficiently in advance of any deadline for any filing with respect to such
Product Trademark or Product Domain Name in the Territory to permit AstraZeneca
to carry out such activity. After such notice, AstraZeneca may undertake such
activity on behalf of and in the name of Ironwood. The expenses of the
selection, filing, prosecution and maintenance of the Product Trademarks and
obtaining and maintaining the Product Domain Name [**]. Each Party will keep the
other Party regularly apprised of the status of its activities under this
Section 7.5.2 and will consult with such other Party (through the IPWG) in good
faith prior to taking any material action with respect to any such Product
Trademark or Product Domain Name.

 

7.5.3.         Trademark and Domain Name Use. The manner of use of the Product
Trademarks and the Product Domain Names will be subject to periodic review by
the JCC. Neither Party will use the Product Trademarks in a way that is
inconsistent with the trademark usage guidelines and the usage instructions
approved by the JCC, and neither Party will use a Trademark confusingly similar
to any of the Product Trademarks with any of its other products in the Territory
or, except as otherwise provided herein, use the Product Trademarks in
combination with its other Trademarks in the Territory in a manner which would
create a composite or combination marks. The Parties will utilize the Product
Trademarks and the Product Domain Names within the Territory only in accordance
with this Agreement and for no other product in the Territory.  Either Party may
utilize the Product Trademarks and the Product Domain Names outside of the
Territory, provided that such use is not reasonably likely to cause confusion or
devalue the Product Trademark or Product Domain Name, as applicable, in the
Territory.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

7.5.4.         Party Name on Product Promotional Material. Subject to Applicable
Law, all Product promotional material in the Territory will include those
Ironwood House Marks as may be requested by Ironwood in a manner that has equal
prominence with AstraZeneca House Marks.

 

7.5.5.         Trademark and Domain Name License. To effectuate the purposes of
this Agreement, Ironwood hereby grants to AstraZeneca a royalty free license, to
use and display the Product Trademarks and to use the Product Domain Names in
connection with the Commercialization of the Products in accordance with this
Section 7.5 and to use the Ironwood House Marks in connection with the
Commercialization of a Product in the Field in the Territory, all in accordance
with this Agreement. All goodwill arising from the use of such Product
Trademarks, Product Domain Names and Ironwood House Marks will inure to the
benefit of Ironwood.

 

7.6.               Enforcement and Defense of Technology Rights.

 

7.6.1.      Monitoring. The IPWG will develop procedures for monitoring Third
Party patent submissions in the Territory. AstraZeneca will be responsible for
executing such procedures and promptly reporting any relevant discovered
activities or information to Ironwood. The costs of such execution [**].

 

7.6.2.      Notice. If Ironwood or AstraZeneca becomes aware that any Ironwood
Technology, AstraZeneca Technology, Collaboration Technology (including Joint
Technology), Development Data, Product Trademark, or Product Domain Name is
infringed or misappropriated by a Third Party in the Territory in the Field, or
Collaboration Technology that is included in AstraZeneca Technology is infringed
or misappropriated by a Third Party outside the Territory, or is subject to an
invalidation action (including any administrative or judicial action, whether
initiated at the State Intellectual Property Office of China or otherwise), or a
declaratory judgment action arising from such infringement (any of the
foregoing, being an “Infringement”), Ironwood or AstraZeneca, as the case may
be, will promptly notify the other Party of such Infringement.

 

7.6.3.      Enforcement and Defense of Product Trademarks and Domain Names.
Subject to Section 5.7, AstraZeneca has the first right (but not the obligation)
to enforce or defend any Product Trademark or Product Domain Name, against an
Infringement in the Territory. If AstraZeneca exercises its right to enforce
(and so defend) any Product Trademark or Product Domain Name pursuant to this
Section 7.6.3, Ironwood will reasonably cooperate with AstraZeneca with respect
to such enforcement or defense, including by joining any lawsuit or proceeding
as a party where such joinder is required under Applicable Law to enforce or so
defend the Product Trademark or Product Domain Name. In the event that
AstraZeneca declines to enforce or so defend the Product Trademark or Product
Domain Name against an Infringement within 90 days (or such shorter period as
may be required to comply with legal or regulatory deadlines which relate to
such Infringement) of becoming aware thereof, Ironwood will have the right to so
enforce or so defend

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

such Product Trademark or Product Domain Name. Irrespective of which Party
controls an action pursuant to this Section 7.6.3, the Parties will collaborate
with respect to such action and the comments of the other Party will not be
unreasonably rejected with respect to strategic decisions and their
implementation with respect to such action. In furtherance of the foregoing, the
Party responsible for any such action will keep the other Party reasonably
informed, in person or by telephone, regarding the status and costs of such
action or proceeding prior to and during any such enforcement or defense.
Neither Party will settle any such action without the written consent of the
other Party, such consent not to be unreasonably withheld, conditioned or
delayed. Neither Party will incur any liability to the other as a consequence of
such litigation or any unfavorable decision resulting therefrom, but for
clarity, this sentence is without limitation of a Party’s other obligations
hereunder, including Sections 9.2 and 9.3.

 

7.6.4.      Costs and Recoveries for Product Trademarks and Domain Names.
Irrespective of which Party prosecutes the action, the costs of any prosecution
or defense of any Infringement of Product Trademarks or Product Domain Names in
the Territory [**] and the proceeds of any awards, judgments or settlements
obtained in connection with an Infringement in the Territory [**].

 

7.6.5.      Enforcement and Defense of Patent Rights. Subject to the terms of
any applicable license as a result of which Ironwood Controls any Patent Rights
included in the Ironwood Technology (i.e., the Existing Agreements or other
Third Party agreements), AstraZeneca has the first right (but not the
obligation) to enforce or defend in connection with any such enforcement
activity any Ironwood Technology in the Territory, AstraZeneca Technology
worldwide (provided that it has the sole right, but not the obligation, with
respect to AstraZeneca Technology that is not Collaboration Technology), and
Collaboration Technology that is not included in AstraZeneca Technology
(including Joint Technology and Development Data) in the Territory, to the
extent either Party has the legal power to enforce or defend such Technology
(“Subject Technology”), against an Infringement in the Territory, provided that
AstraZeneca may not admit the invalidity or unenforceability of any Ironwood
Technology or Joint Technology without first consulting with Ironwood and
obtaining Ironwood’s prior written consent to such admission. If AstraZeneca
exercises its right to enforce (and so defend) any Subject Technology pursuant
to this Section 7.6.5, Ironwood will reasonably cooperate with AstraZeneca with
respect to such enforcement or defense, including by joining any lawsuit or
proceeding as a party where such joinder is required under Applicable Law to
enforce or so defend the Subject Technology. In the event that AstraZeneca
declines to enforce or so defend the Subject Technology (other than AstraZeneca
Technology that is not Collaboration Technology) against an Infringement within
90 days (or such shorter period as may be required to comply with legal or
regulatory deadlines which relate to such Infringement) of becoming aware
thereof, Ironwood will have the right to so enforce or so defend such Subject
Technology against such Infringement. Ironwood has the first right (but not the
obligation) to enforce and defend any Joint Technology against an Infringement
outside the Territory, provided that

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Ironwood may not admit the invalidity or unenforceability of such Technology
without first consulting with AstraZeneca and obtaining AstraZeneca’s prior
written consent to such admission. In the event that Ironwood declines to
enforce or so defend such Technology against an Infringement within 90 days (or
such shorter period as may be required to comply with legal or regulatory
deadlines which relate to such Infringement) of becoming aware thereof,
AstraZeneca will have the right to so enforce or defend such Technology.
Irrespective of which Party controls an action pursuant to this Section 7.6.5,
the Parties will collaborate with respect to such action and the comments of the
other Party will not be unreasonably rejected with respect to strategic
decisions and their implementation with respect to such action. In furtherance
of the foregoing, the Party responsible for any such action will keep the other
Party reasonably informed, in person or by telephone, regarding the status and
costs of such action or proceeding prior to and during any such enforcement or
defense. Neither Party will settle any such action without the written consent
of the other Party, such consent not to be unreasonably withheld, conditioned or
delayed. Neither Party will incur any liability to the other as a consequence of
such litigation or any unfavorable decision resulting therefrom, including any
decision holding any such Subject Technology invalid, not infringed, not
misappropriated or unenforceable, but for clarity, this sentence is without
limitation of a Party’s other obligations hereunder, including Sections 9.2 and
9.3.

 

7.6.6.      Costs and Recoveries for Defense of Patent Rights.

 

(a)           In the Territory. The Parties agree that, irrespective of which
Party prosecutes the action, the costs of any prosecution or defense of any
Infringement in the Territory [**] and the proceeds of any awards, judgments or
settlements obtained in connection with an Infringement in the Territory [**].

 

(b)           Outside the Territory. Costs of any prosecution or defense of any
Infringement relating to Subject Technology outside the Territory [**] and the
proceeds of any awards, judgments, or settlements obtained in connection with
any prosecution or defense against any such Infringement [**].

 

7.7.               Third Party Claims.

 

7.7.1.                 Third Party Claims - Course of Action. If the
Development, Commercialization or Manufacture of a Product or the use of any
Product Trademark or Product Domain Name, in each case, under this Agreement is
alleged by a Third Party to infringe a Third Party’s Patent Right(s) or
Trademark rights or misappropriate a Third Party’s trade secret, the Party
becoming aware of such allegation will promptly notify the other Party thereof,
in writing, reasonably detailing the claim.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

7.7.2.                 Third Party Suit. If a Third Party sues a Party (the
“Sued Party”) alleging that the Sued Party’s or the Sued Party’s Affiliates’ or
Sublicensees’, Development, Manufacture or Commercialization of the Product or
use of the Product Trademark or Product Domain Name infringes or will infringe
said Third Party’s Patent Right(s) or Trademark rights or misappropriates said
Third Party’s trade secret, then upon the Sued Party’s request and in connection
with the Sued Party’s defense of any such Third Party suit, the other Party will
provide reasonable assistance to the Sued Party for such defense and will join
such suit if deemed a necessary party; provided that for suits relating to any
Product Trademark or Product Domain Name, subject to Section 5.7, AstraZeneca
will have the first right (but not the obligation) and Ironwood will have the
second right (but not the obligation) to assume the defense of any such suit;
provided further that, with respect to any suit AstraZeneca elects to
defend, Ironwood may select separate counsel of its own choosing at Ironwood’s
expense. The Sued Party (or the controlling Party in the case of suits relating
to any Product Trademark or Product Domain Name) will keep the other Party, if
such other Party has not joined in such suit, reasonably informed with respect
to the status of such suit on a quarterly basis, in person or by telephone,
prior to and during the pendency of any such suit. The Sued Party or the
controlling Party, as applicable, will not admit the invalidity of any Patent
Right within the Ironwood Patent Rights, the AstraZeneca Patent Rights, or Joint
Patent Rights, nor settle any such suit, without written consent of the other
Party, such consent not to be unreasonably withheld (and Ironwood’s consent will
not be required with respect to AstraZeneca Collaboration Patent Rights), and in
the case of the Product Trademarks and Product Domain Names, neither Party will
submit any argument or take any position in such Third Party suit which may in
any way lessen, impair or undermine the Product Trademarks, or settle any such
suit, without written consent of the other Party, such consent not to be
unreasonably withheld. Subject to the Parties’ respective indemnity obligations
pursuant to Sections 9.2 and 9.3, all litigation costs and expenses incurred
with respect to a Third Party suit, including settlement costs, royalties paid
in settlement of any such suit, and the payment of any damages to the Third
Party, under this Section 7.7.2 [**] and the proceeds of any awards, judgments
or settlements obtained in connection with any such suit [**].

 

7.8.               Third Party Licenses.  If, either Party in good faith
believes that, in order to avoid infringing or misappropriating any Third
Party’s Patent Right, Know-How, Trademark or domain name, that is necessary to
Develop, Manufacture or Commercialize the Licensed Compound or Products in the
Territory, it is necessary to obtain a license to such Patent Right, Know-How,
Trademark or domain name, from such Third Party, then such Party will deliver
notice thereof to the other Party setting forth the basis for such belief. With
respect to (a) licenses relating to any such Trademark or domain name,
AstraZeneca will have the first right (but not the obligation) and (b) licenses
relating to any such Patent Rights or Know-How, Ironwood will have the first
right (but not the obligation), in each case, through counsel of its choosing,
to negotiate and obtain a license from such Third Party. The costs of any such
license under clause (a) or (b) [**]. If the Party with the first right

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

to negotiate and obtain any such license elects not to obtain such license, the
other Party may, at its cost and expense, through counsel of its choosing,
negotiate and obtain a license from such Third Party.

 

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

 

7.10.             Patent Certifications. Each Party will immediately give
written notice to the other of any certification of which it becomes aware has
been filed pursuant to any foreign equivalent to 21 U.S.C. § 355(b)(2)(A) or §
355(j)(2)(A)(vii) (or any amendment or successor statute thereto) claiming that
the Ironwood Patent Rights, AstraZeneca Patent Rights, or Collaboration Patent
Rights, in each case, in the Territory covering the Product are invalid or that
infringement will not arise from the manufacture, use or sale in the Territory
of such Third Party product by a Third Party. Any response to such certification
shall be governed by Section 7.6.5, provided that if AstraZeneca decides not to
respond to such certification, including by bringing infringement proceedings
against such Third Party, AstraZeneca will give notice to Ironwood of its
decision not to bring suit within ten business days after receipt of notice of
such certification (or, if the time period permitted by law is less than 20
business days, within half of the time period permitted by law for AstraZeneca
to commence such action) and Ironwood may then, but will not be obligated to,
bring suit against the Third Party that filed the certification in accordance
with its second rights as described in Section 7.6.5. Each Party shall cooperate
with the other Party, including joining any action, as described in
Section 7.6.5. The costs and recoveries of the Parties under this Section 7.10
[**]. In the event of a conflict between this Section 7.10 and Section 7.6.5,
this Section 7.10 will control.

 

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

 

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

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

7.13.             Registration and Submission of the Agreement. In the event
that AstraZeneca or its Affiliate or Sublicensee is required, upon advice of
counsel, to disclose or register this Agreement (or any portion of this
Agreement), or one or more confirmatory patent or trademark license agreements
to a government authority in the Territory, including in China, the Ministry of
Commerce or the State Intellectual Property Office (or any agency or bureau
thereof), AstraZeneca will, and will cause its Affiliates and Sublicensees to,
provide prior written notice to Ironwood of such disclosure requirement and
cooperate in good faith to prepare and execute an abbreviated license agreement,
in form and substance reasonably acceptable to Ironwood, solely for purposes of
such disclosure, with the understanding that the terms and conditions of this
Agreement will control in the event of any dispute regarding the interpretation,
applicability or enforcement of the abbreviated license agreement, and disclose
or register such abbreviated license agreement.

 

8.                                      TERM AND TERMINATION

 

8.1.               Term. The term of this Agreement will commence on the
Effective Date and will continue in full force and effect until there is no
longer a Development Plan or Commercialization Plan contemplating Development or
Commercialization of a Product in the Territory, unless earlier terminated as
provided in this Article 8 (the “Term”).

 

8.2.               Termination for Cause.

 

8.2.1.         Termination for Material Breach. This Agreement may be terminated
effective immediately by written notice by either Party at any time during the
Term if the other Party materially breaches this Agreement, which breach remains
uncured for [**] days measured from the date written notice of such breach is
given to the breaching Party by the non-breaching Party, which notice will
specify the nature of the breach and demand its cure; provided, however, that if
such breach is not capable of being cured within the stated period and the
breaching Party uses Commercially Reasonable Efforts to cure such breach during
such period and presents a mutually agreeable remediation plan for such breach,
this Agreement will not terminate and the cure period will be extended for such
period provided in the remediation plan as long as the breaching party continues
to use Commercially Reasonable Efforts to pursue the cure as provided in such
remediation plan.  Further, in the case of a dispute during the cure period with
respect to whether a material breach has occurred, the non-breaching Party shall
not have the right to terminate this Agreement until it complies with the
applicable dispute resolution procedures hereunder, including those set forth in
Section 10.1.2, and the dispute has been resolved pursuant to such procedures
and breach remains uncured [**] days after the final resolution of the dispute
through such dispute resolution procedures. Notwithstanding anything to the
contrary set forth in this Agreement but subject to the limitations set forth in
Section 9.6, termination will not be deemed to relieve a defaulting party from
any liability arising from such default.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

8.2.2.         Termination for Safety Reasons. in the event that AstraZeneca
determines in good faith in accordance with its internal procedures that there
is a material safety issue associated with the Product, which safety issue was
not disclosed to AstraZeneca prior to the Effective Date, then AstraZeneca shall
discuss the matter with Ironwood as promptly as practicable.  Provided that
AstraZeneca does not modify its decision following such discussion, AstraZeneca
may terminate this Agreement effective upon written notice thereof to Ironwood.

 

8.2.3.         Bankruptcy. If the other Party or a Local Affiliate files in any
court or agency, pursuant to any statute or regulation of any state or country,
a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of that Party or of
its assets, or if the other Party proposes a written agreement of composition or
extension of its debts, or if the other Party is served with an involuntary
petition against it, filed in any insolvency proceeding, and such petition is
not dismissed within [**] days after the filing thereof, or if the other Party
proposes or is a Party to any dissolution or liquidation, or if the other Party
makes an assignment for the benefit of its creditors (each, a “Bankruptcy”),
this agreement may be terminated, provided that in the case of a Local
Affiliate’s Bankruptcy, if AstraZeneca notifies Ironwood within [**] days
following such Bankruptcy that it will make reasonable arrangements to perform
the Development or Commercialization activities assigned to such Local Affiliate
in light of such Bankruptcy and then does so within [**] days following such
Bankruptcy, Ironwood may not terminate this Agreement due to such Bankruptcy.

 

8.3.               Termination for Convenience. Prior to its expiration, this
Agreement may be terminated at any time by AstraZeneca effective upon at least
[**] days’ prior written notice to Ironwood for any reason.

 

8.4.               Change of Control.

 

8.4.1.         Change of Control Notice. Each Party will notify the other in
writing, referencing this Section 8.4.1, immediately upon any Change of Control,
and will provide such notice where permitted at least [**] days prior to the
Change of Control.

 

8.4.2.         Consequences of a Change of Control of AstraZeneca. In the event
that AstraZeneca, AstraZeneca PLC (“Parent”) or [**] is subject to a Change of
Control which could reasonably be expected to lead to an Impairment, Ironwood
may elect, in its sole discretion, to (a) continue this Agreement in accordance
with its terms or (b) terminate this Agreement effective upon [**] days’ written
notice of termination (or any sooner date specified in such written notice),
such notice to be delivered within [**] days after the Fair Market Value is
determined pursuant to this Section 8.4.2. Within [**] days following the Change
of Control, Ironwood may provide notice to AstraZeneca requesting a
determination of the Fair Market Value of the Product rights subject to

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

acquisition by Ironwood upon a termination pursuant to this Section 8.4.2 and
the failure to so request such valuation will be deemed the election to continue
this Agreement in accordance with its terms. Each Party will provide the
Valuation Panel with all information reasonably requested by the Valuation Panel
in connection with the determination of Fair Market Value. In connection with a
termination under this Section 8.4.2, Ironwood will be required to pay
AstraZeneca an amount equal to the Fair Market Value of the Product rights
reacquired by Ironwood in a lump sum payment as of the effective date of the
termination.

 

8.4.3.                 Consequences of a Change of Control of Ironwood. In the
event Ironwood is subject to a Change of Control, AstraZeneca may elect, in its
sole discretion to (a) continue this Agreement in accordance with its terms or
(b) limit the role of the JCC such that the JCC’s sole role will be to review
and approve the Commercialization Budget. Furthermore, in the event Ironwood is
subject to a Change of Control, Ironwood’s right to elect to co-promote the
Product under Section 3.5.4 will terminate.

 

8.5.               Effects of Termination and Expiration.

 

8.5.1.                 Effects of Termination by Ironwood or by AstraZeneca for
Convenience. If this Agreement is terminated by Ironwood under Section 8.2.1,
8.2.3, or 8.4.2, or by AstraZeneca under Section 8.3, then the following
provisions will be effective upon such termination:

 

(a)           All licenses granted by Ironwood to AstraZeneca hereunder will
automatically terminate, except to the extent required for AstraZeneca to
perform its surviving obligations hereunder and correspondingly the sublicense
rights granted to AstraZeneca will remain in effect solely to allow AstraZeneca
to sublicense under such rights and licenses solely for the aforesaid purpose;

 

(b)           All licenses granted by AstraZeneca to Ironwood herein will become
fully paid up, fully sublicensable, irrevocable, perpetual, royalty-free
licenses and will be expanded to grant Ironwood corresponding rights in the
Territory to the extent such rights are not already granted hereunder;

 

(c)           AstraZeneca will assign to Ironwood all right, title, and interest
in and to (i) all Regulatory Submissions and Regulatory Approvals pertaining to
the Licensed Compound or Product Controlled by AstraZeneca (excluding Regulatory
Submissions and Regulatory Approvals to the extent pertaining to AstraZeneca’s
proprietary compounds or products that are not or do not contain the Licensed
Compound as the sole active ingredient), (ii) all of AstraZeneca’s rights, title
and interest in and to any Product Trademark (including, without limitation, the
goodwill symbolized by such Product Trademark) used to brand the Product
(excluding, for clarity, any AstraZeneca House Marks)

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

and any Product Domain Names, and (iii) all of AstraZeneca’s interest in any
copyrights to the extent necessary or useful to enable Ironwood to continue to
conduct Development as contemplated in the then current Development Plan and to
use the current versions of promotional materials and sales training materials
for the Products in the Territory (excluding, for clarity, any AstraZeneca House
Marks) for a period of [**] months or shorter if required after the date of
termination of this Agreement to comply with Applicable Law;

 

(d)           AstraZeneca will furnish Ironwood with reasonable cooperation
(i) to assure a smooth transition of any clinical or other studies in progress
related to the Licensed Compound or Product(s) which Ironwood determines to
continue in compliance with Applicable Law and ethical guidelines applicable to
the transfer or termination of any such studies, and (ii) as reasonably
necessary for Ironwood to assume the Commercialization activities of the
Product(s) in the Territory. In addition, AstraZeneca will return all Ironwood
Confidential Information to Ironwood as set forth in Section 5.1.5. Ironwood
will return all AstraZeneca Confidential Information to AstraZeneca as set forth
in Section 5.1.5; provided however, that Ironwood may retain any such
Confidential Information that is reasonably necessary or useful for Ironwood to
develop, manufacture and commercialize the Licensed Compound or Products or
exercise its rights hereunder after the effective date of such termination (but
such right of retention shall not be construed to expand the scope of the rights
granted to Ironwood hereunder);

 

(e)           Until termination is effective, AstraZeneca will continue to use
Commercially Reasonable Efforts to perform its obligations under the Development
Plan and the Commercialization Plan then in effect, except with respect to
activities that Ironwood elects to discontinue; and

 

(f)            Sections 8.5.1(a) will be effective upon any such termination,
and Sections 8.5.1(b), 8.5.1(c), 8.5.1(d), and 8.5.1(e) will be effective upon
such termination or, in the case of termination by AstraZeneca pursuant to
Section 8.3 or by Ironwood pursuant to Section 8.4, upon Ironwood’s earlier
election following a notice of termination. All activities performed by
AstraZeneca on behalf of Ironwood in this Section 8.5.1 will be at AstraZeneca’s
cost and expense. At the election of AstraZeneca at the time of termination, the
Parties will negotiate in good faith a transition agreement in order to effect
the provisions of this Section 8.5.1, provided, however, that the inability of
the Parties to agree on the terms of such agreement shall not relive AstraZeneca
of its obligations under this Section 8.5.1.

 

8.5.2.                 Effects of Termination by AstraZeneca for Ironwood
Material Breach or Insolvency. If AstraZeneca terminates this Agreement pursuant
to Section 8.2.1 or 8.2.3, all licenses granted by (a) Ironwood to AstraZeneca

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

hereunder, will terminate, and (b) AstraZeneca to Ironwood hereunder will become
fully paid up, fully sublicensable, irrevocable, perpetual, royalty-free
licenses and will be expanded to grant Ironwood corresponding rights in the
Territory to the extent such rights are not already granted hereunder, and
neither Party will have any further contractual obligations to the other
hereunder, except with respect to any provisions which survive the termination
of this Agreement by their respective terms or as set forth in Section 8.6, and
obligations accrued but remaining outstanding as of the effectiveness of
termination. Ironwood will return all of AstraZeneca’s Confidential Information
to AstraZeneca as set forth in Section 5.1.5; provided however, that Ironwood
may retain any such Confidential Information that is reasonably necessary for
Ironwood to develop, manufacture and commercialize the Licensed Compound or
Products or exercise its rights hereunder after the effective date of such
termination or perform its obligations under this Agreement in the Territory
(but such right of retention shall not be construed to expand the scope of the
rights granted to Ironwood hereunder). Notwithstanding the foregoing, in lieu of
such termination, AstraZeneca may elect (i) [**] and (ii) to [**]. Furthermore,
if AstraZeneca is entitled to terminate this Agreement due to Ironwood’s
material breach of its regulatory obligations as provided in Section 3.2, in
lieu of terminating this Agreement, AstraZeneca may elect to perform such
activities on behalf of and in the name of Ironwood in accordance with the
Development Plan, in which case Ironwood will provide any assistance reasonably
requested by AstraZeneca in transitioning and performing such activities,
including the execution of any power of attorney or similar document necessary
for AstraZeneca to perform such activity.

 

8.5.3.                 Effects of Termination for Safety Reasons. If AstraZeneca
terminates this Agreement for safety reasons pursuant to Section 8.2.2, then the
following provisions will be effective upon such termination:

 

(a)           All licenses granted by Ironwood to AstraZeneca hereunder will
automatically terminate, except to the extent required for AstraZeneca to
perform its surviving obligations hereunder, and correspondingly the sublicense
rights granted to AstraZeneca will remain in effect solely to allow AstraZeneca
to sublicense under such rights and licenses solely for the aforesaid purpose;

 

(b)           Notwithstanding the survival provisions of Section 8.6, all
licenses granted by AstraZeneca to Ironwood hereunder will automatically
terminate with respect to any Technology that is the cause of the safety issue
underlying such termination, and all other licenses granted by AstraZeneca to
Ironwood hereunder will survive such termination;

 

(c)           AstraZeneca will return all Ironwood Confidential Information to
Ironwood and Ironwood will return all AstraZeneca Confidential Information to
AstraZeneca, each as set forth in Section 5.1.5; provided however, that Ironwood
may retain any such Confidential Information that

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

is reasonably necessary or useful for Ironwood to exercise its rights hereunder
after the effective date of such termination (but such right of retention shall
not be construed to expand the scope of the rights granted to Ironwood
hereunder);

 

(d)           AstraZeneca will provide such documentation in its possession and
control relating thereto and discuss such safety issue with Ironwood in good
faith as reasonably requested by Ironwood for at least [**] days after the
effective date of such termination to assist Ironwood and to identify, further
characterize, and fully document such safety issue. AstraZeneca’s out-of-pocket
costs for such assistance, if any, shall be paid by Ironwood. For clarity,
AstraZeneca will not be required to generate any new information regarding such
material safety issue or undertake any Development or Commercialization
activities in the portion of the Territory to which any termination relates
after providing notice of termination for a material safety issue under
Section 8.2.2; and

 

(e)           If, within [**] years after the effective date of a termination of
this Agreement pursuant to Section 8.2.2, either (i) Ironwood receives express
authorization from a Regulatory Authority to recommence or continue the
development and commercialization of the Product or (ii) a Safety Panel
determines that it is reasonable for Ironwood to continue the development and
commercialization of the Product, taking into account all safety issues with the
Product, then Ironwood shall be afforded the more expanded reversion rights with
respect to the Product as to which it would have been entitled had AstraZeneca
terminated this Agreement pursuant to Section 8.3; provided, however, that
Ironwood’s indemnification obligations with respect to the Product shall remain
in effect and AstraZeneca shall no longer have any indemnification obligation to
Ironwood or any Ironwood Indemnified Party with respect to any Product sold by
or on behalf of Ironwood or its Affiliates or licensees after the date of such
termination.  Ironwood will have the right to convene a Safety Panel during such
[**] year period upon written notice to AstraZeneca. Each Party will reasonably
cooperate with and provide any reasonably requested information to such Safety
Panel.

 

8.6.               Survival of Certain Obligations. Expiration or termination of
this Agreement will not relieve the Parties of any obligation accruing before
such expiration or termination. The provisions of this Agreement that survive
expiration or termination of this Agreement are: Articles 1, 4 (with respect to
any costs or expenses incurred, or Net Sales made, prior to the effective date
of such expiration or termination, or costs and expenses incurred after such
date if expressly contemplated as costs and expenses that may be incurred
hereunder following the expiration or termination hereof and included as Program
Expenses notwithstanding such expiration or termination (e.g., Section 3.3.2)),
Sections 2.2, 2.3 (solely with respect to the rights granted to Ironwood
thereunder), 2.4 (solely with respect to the rights granted to Ironwood
thereunder), 3.3.2 (for Product sold in the Territory

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

during the Term), 4.7, 5.1, 6.6, Article 7 (solely with respect to those
provisions relating to Joint Technology or Development Data), Sections 7.2,
7.12, and Articles 8, 9 and 10. Any expiration or early termination of this
Agreement will be without prejudice to the rights of either Party against the
other accrued or accruing under this Agreement before termination. In no event
will any milestone payment be due hereunder after the date on which a notice of
termination is provided hereunder. In addition, Sections 4.4, 4.5, 4.6 and 4.8
shall apply with respect to payments due hereunder after expiration or
termination of this Agreement.

 

9.                                      PRODUCT LIABILITY, INDEMNIFICATION, AND
INSURANCE

 

9.1.               Sharing of Liability Expenses. The Parties will share all
losses, damages, liabilities, settlements, penalties, fines and expenses
(including reasonable attorneys’ fees and expenses) arising from claims against
the Parties or their respective Affiliates or any of their respective employees,
officers, directors, agents or permitted Sublicensees by Third Parties
(collectively, “Liabilities” and such claims, “Third Party Claims”) to the
extent such Liabilities relate to the Development or Manufacturing of the
Licensed Compound or Product for the Territory under this Agreement or the
Commercialization of the Product in the Territory, including any (a) the death
or bodily injury of any person (or similar claims) (“Product Liability Claims”)
in the Territory on account of the use of any Product sold in the Territory
during the Term, (b) any recall or withdrawal of Product sold in the Territory
during the Term, or (c) any infringement claims brought by any Third Parties in
the Territory, which are the subject of Section 7.7 (collectively, “Shared
Liability Claims”), as if such Liabilities were Program Expenses at the time
such Liabilities were incurred by the applicable Party, except to the extent
that one of the Parties would be responsible for such Liabilities (assuming they
were incurred by the other Party) under Section 9.2 or 9.3.

 

9.2.               Indemnification by Ironwood. Ironwood shall indemnify, defend
and hold harmless AstraZeneca, its Affiliates, and each of its and their
respective employees, officers, directors agents and permitted Sublicensees
(each, a “AstraZeneca Indemnified Party”) from and against any and all
Liabilities arising out of Third Party Claims to the extent resulting from or
arising out of:

 

(a)           any intentional misconduct or negligence on the part of Ironwood
or any of its Affiliates or Sublicensees in performing any activity contemplated
by this Agreement or any Ancillary Agreement;

 

(b)           any Ironwood representation or warranty set forth in this
Agreement or any Ancillary Agreement being untrue;

 

(c)           the Development, Manufacture or Commercialization in the Field in
the Territory of the Licensed Compound or Product by or on behalf of Ironwood or
any of its Affiliates, which claims are based on acts or omissions occurring or
failing to occur, in whole or in part, prior to the Effective Date or are
conducted during the Term in support of

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Development or Commercialization outside the Territory, including in each case
(i) any violation of Applicable Law in connection with such Development or
Commercialization and (ii) personal injury or similar claims arising from the
use of any Products prior to the Effective Date;

 

(d)           the Development, Manufacture or Commercialization of the Licensed
Compound or Product by or on behalf of Ironwood or any of its Affiliates,
licensees (including Forest, Almirall and Astellas) or Sublicensees (i) after
the end of the Term (including the use of any intellectual property or materials
that revert to Ironwood following expiration or termination of this Agreement),
(ii) outside the Territory or (iii) outside the Field in the Territory;

 

(e)           any breach by Ironwood of any of its covenants or obligations
hereunder or under any Ancillary Agreement or (except to the extent due to a
breach of this Agreement by AstraZeneca) under the Existing Agreements; or

 

(f)            the exercise by Ironwood, its Affiliates, licensees or
Sublicensees (excluding such exercise by AstraZeneca, its Affiliates, and
Sublicensees as licensees of Ironwood and Sublicensees of AstraZeneca hereunder)
of rights under Section 2.2, including any exploitation of the Joint Technology
or the Development Data for purposes other than exploitation of the Licensed
Compound and Products by Ironwood, its Affiliates, licensees or Sublicensees
under this Agreement or any Ancillary Agreement;

 

except, in each case, to the extent AstraZeneca is obligated to indemnify
Ironwood for such Liabilities pursuant to Section 9.3.

 

9.3.               Indemnification by AstraZeneca. AstraZeneca shall indemnify,
defend and hold harmless Ironwood, its Affiliates, Sublicensees, distributors
and each of its and their respective employees, officers, directors and agents
(each, an “Ironwood Indemnified Party”) from and against any and all Liabilities
arising out of Third Party Claims to the extent resulting from or arising out
of:

 

(a)           any intentional misconduct or negligence on the part of
AstraZeneca or any of its Affiliates or Sublicensees in performing any activity
contemplated by this Agreement or any Ancillary Agreement;

 

(b)           any AstraZeneca representation or warranty set forth in this
Agreement or any Ancillary Agreement being untrue;

 

(c)           any breach by AstraZeneca of any of its covenants or obligations
hereunder or under any Ancillary Agreement; or

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(d)           any exploitation of the Joint Technology or the Development Data
by AstraZeneca or its Affiliates, licensees or Sublicensees for purposes other
than exploitation of the Licensed Compound and Products;

 

except, in each case, to the extent Ironwood is obligated to indemnify
AstraZeneca for such Liabilities pursuant to Section 9.2.

 

9.4.               Procedure. Each Party will notify the other in the event it
becomes aware of a claim for which indemnification may be sought hereunder or
for which Liability is shared pursuant to this Article 9. In case any proceeding
(including any governmental investigation) is instituted involving any Party in
respect of which indemnity may be sought pursuant to this Article 9, such Party
(the “Indemnified Party”) will promptly notify the other Party (the
“Indemnifying Party”) in writing and the Indemnifying Party and Indemnified
Party will meet to discuss how to respond to any claims that are the subject
matter of such proceeding. The Indemnifying Party, upon request of the
Indemnified Party, will retain counsel reasonably satisfactory to the
Indemnified Party to represent the Indemnified Party and will pay the fees and
expenses of such counsel related to such proceeding. In any such proceeding, the
Indemnified Party will have the right to retain its own counsel, but the fees
and expenses of such counsel will be at the expense of the Indemnified Party
unless (i) the Indemnifying Party and the Indemnified Party will have mutually
agreed to the retention of such counsel or (ii) the named parties to any such
proceeding (including any impleaded parties) include both the Indemnifying Party
and the Indemnified Party and representation of both Parties by the same counsel
would be inappropriate due to actual or potential differing interests between
them. All such fees and expenses incurred pursuant to Section 9.2 or 9.3 will be
reimbursed as they are incurred. The Indemnifying Party will not be liable for
any settlement of any proceeding unless effected with its written consent. The
Indemnifying Party will not, without the written consent of the Indemnified
Party, effect any settlement of any pending or threatened proceeding in respect
of which the Indemnified Party is, or arising out of the same set of facts could
have been, a party and indemnity could have been sought hereunder by the
Indemnified Party, unless such settlement includes an unconditional release of
the Indemnified Party from all liability on claims to which the indemnity
relates that are the subject matter of such proceeding. Notwithstanding the
foregoing, if there is a conflict between this Section 9.4 and Section 7.7, the
procedures in Article 7 will control.

 

9.5.               Insurance.  Each Party further agrees to use Commercially
Reasonable Efforts to obtain and maintain, during the Term, commercial general
liability insurance, including products liability insurance, with reputable and
financially secure insurance carriers to cover its indemnification obligations
under Sections 9.1, 9.2 or 9.3; provided that [**].

 

9.6.               Liability Limitations. NOTWITHSTANDING ANYTHING IN THIS
AGREEMENT OR ANY ANCILLARY AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER
PARTY BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT,
SPECIAL, PUNITIVE, OR

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXEMPLARY DAMAGES, OR FOR LOST PROFITS, LOST MILESTONES, OR LOST ROYALTIES UNDER
THIS AGREEMENT OR ANY ANCILLARY AGREEMENT, WHETHER IN CONTRACT, WARRANTY,
NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a) THE
DEVELOPMENT, COMMERCIALIZATION, USE OR SALE OF ANY LICENSED COMPOUND OR PRODUCT
DEVELOPED, OR COMMERCIALIZED HEREUNDER OR UNDER ANY ANCILLARY AGREEMENT, OR
(b) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT
OR ANY ANCILLARY AGREEMENT. THE FOREGOING LIMITATIONS IN THIS SECTION 9.6 SHALL
NOT APPLY TO (I) ANY LIABILITY OF EITHER PARTY ARISING FROM ITS OR ITS
AFFILIATE’S OR SUBCONTRACTOR’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, (II) ANY
CLAIMS UNDER SECTION 9.1, 9.2 OR 9.3 OR (III) ANY LIABILITY OF EITHER PARTY FOR
BREACH OF SECTION 5.1 OR SECTIONS 5.2.1 or 5.2.2.

 

10.                               MISCELLANEOUS.

 

10.1.             Governing Law; Jurisdiction; Dispute Resolution.

 

10.1.1.      Governing Law. The interpretation and construction of this
Agreement will be governed by the laws of the State of New York, excluding any
conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive law of
another jurisdiction.

 

10.1.2.      Dispute Resolution. In the event of a dispute arising out of or
relating to this Agreement other than a matter governed by Sections 3.1.1(f),
3.4.1(f), and 3.5.1(f), either Party will provide written notice of the dispute
to the other, in which event the dispute will be referred to the executive
officers designated below or their successors, for attempted resolution by good
faith negotiations within [**] days after such notice is received. The
designated officers are initially as follows:

 

For Ironwood: Its Chief Executive Officer or his designate

For AstraZeneca: Its Regional VP for Asia Pacific or his designate

 

In the event the designated executive officers do not resolve such dispute
within the allotted [**] days, either Party may, after the expiration of the 30
day period, seek to resolve the dispute through arbitration in accordance with
Section 10.1.3. The Parties acknowledge that (a) the failure of the JDC, JOC or
JCC to resolve a JDC Deadlock, JOC Deadlock or JCC Deadlock, as applicable,
which failure does not involve a breach by a Party of its obligations hereunder
will not be deemed a dispute subject to this Section 10.1.2 or Section 10.1.3
and (b) a matter that is subject to the final decision-making of a Party or its
committee representatives hereunder is not subject to this Section 10.1.2 or
Section 10.1.3 (except to extent a dispute arises as to whether such Party has

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

exercised such decision-making authority in accordance with its obligation to
use Commercially Reasonable Efforts hereunder).

 

10.1.3.              Arbitration.

 

(a)           Claims. Any claim, dispute, or controversy of whatever nature
arising between the Parties out of or relating to this Agreement that is subject
to but not resolved under Section 10.1.2 within the required [**] day time
period, including any action or claim based on tort, contract, or statute
(including any claims of breach or violation of statutory or common law
protections from discrimination, harassment and hostile working environment), or
concerning the interpretation, effect, termination, validity, performance or
breach of this Agreement (“Claim”), will be resolved by final and binding
arbitration before a panel of three experts with relevant industry experience
(the “Arbitrators”). One Arbitrator will be chosen by Ironwood and one
Arbitrator will be chosen by AstraZeneca within 15 days from the notice of
initiation of arbitration. The third Arbitrator will be chosen by mutual
agreement of the Arbitrator chosen by Ironwood and the Arbitrator chosen by
AstraZeneca within 15 days of the date that the last of such Arbitrators were
appointed. If the decisions of the Arbitrators will be enforced in China, the
Arbitrators will be administered by the Hong Kong International Arbitration
Center in Hong Kong in accordance with the then-effective International Chamber
of Commerce (“ICC”) arbitration rules or procedures regarding commercial or
business disputes. For all other Claims, the Arbitrators will be administered by
the ICC in accordance with its then existing arbitration rules or procedures
regarding commercial or business disputes and such arbitration will take place
in New York, New York. In each case, the Arbitrators will be instructed by the
Parties to complete the arbitration within 90 days after selection of the final
Arbitrator.

 

(b)           Arbitrators’ Award. The Arbitrators will, within 15 calendar days
after the conclusion of the arbitration hearing, issue a written award and
statement of decision describing the essential findings and conclusions on which
the award is based, including the calculation of any damages awarded. The
decision or award rendered by the Arbitrators will be final and non-appealable,
and judgment may be entered upon it in accordance with Applicable Law in China,
the State of New York or any other court of competent jurisdiction. Any awards
authorized by the Arbitrators will be subject to the limitations set forth in
Section 9.6. The Arbitrators will not be authorized to reform, modify or
materially change this Agreement or any Ancillary Agreement.

 

(c)           Costs. Each Party will bear its own attorney’s fees, costs, and
disbursements arising out of the arbitration and the costs of the arbitrator
selected by it, and will pay an equal share of the fees and costs of the third
arbitrator; provided, however, the Arbitrators will be authorized to

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

determine whether a party is the prevailing party, and if so, to award to that
prevailing party reimbursement for its reasonable attorneys’ fees, costs and
disbursements (including, for example, expert witness fees and expenses,
photocopy charges, travel expenses, etc.), or the fees and costs of the
administrator of the arbitration and the Arbitrators.

 

(d)           Compliance with this Agreement. Unless the Parties otherwise agree
in writing, during the period of time that any arbitration proceeding is pending
under this Agreement, the Parties will continue to comply with all those terms
and provisions of this Agreement that are not the subject of the pending
arbitration proceeding.

 

(e)           Injunctive or Other Equity Relief. Nothing contained in this
Agreement will deny any Party the right to seek injunctive or other equitable
relief from a court of competent jurisdiction applying the laws of that court in
the context of a bona fide emergency or prospective irreparable harm, and such
an action may be filed and maintained notwithstanding any ongoing arbitration
proceeding.

 

10.2.             Force Majeure. No liability will result from, and no right to
terminate will arise, in whole or in part, based upon any delay in performance
or non-performance, in whole or in part, by either of the Parties to this
Agreement to the extent that such delay or non-performance is caused by an event
of Force Majeure. “Force Majeure” means an event that is beyond a non-performing
Party’s reasonable control, including an act of God, act of the other Party,
war, riot, civil commotion, strike, terrorist act, malicious damage, epidemic,
quarantine, fire, flood, storm, natural disaster, whether or not it is later
held to be invalid or inapplicable. The Force Majeure Party will within ten days
of the occurrence of the Force Majeure event, give written notice to the other
Party stating the nature of the Force Majeure event, its anticipated duration
and any action being taken to avoid or minimize its effect. Any suspension of
performance will be of no greater scope and of no longer duration than is
reasonably required and the Force Majeure Party will use reasonable effort to
remedy its inability to perform; provided, however, if the suspension of
performance continues or is anticipated to continue for 30 days after the date
of the occurrence, the unaffected Party will have the right but not the
obligation to perform on behalf of the Force Majeure Party for a period of such
Force Majeure and such additional period as may be reasonably required to assure
a smooth and uninterrupted transition of such activities. If such failure to
perform would constitute a material breach of this Agreement in the absence of
such event of Force Majeure, and continues for one year from the date of the
occurrence and the Parties are not able to agree on appropriate amendments
within such period, such other Party will have the right, notwithstanding the
first sentence of this Section 10.2, to terminate this Agreement immediately by
written notice to the Force Majeure Party.  In the case of such a termination,
neither Party will have any liability to the other except for those rights and
liabilities that accrued prior to the date of termination or that survive
termination of this Agreement and the consequences of termination pursuant to
Sections 8.5.1 or 8.5.2, as applicable, shall apply as if such termination was a
termination as to which

 

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treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

such consequences applied. Notwithstanding the foregoing, nothing in this
Section 10.2 will excuse or suspend the obligation to make any payment due
hereunder in the manner and at the time provided.

 

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

 

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

 

10.5.             Notices.

 

10.5.1.              Notice Requirements. Any notice, request, demand, waiver,
consent, approval or other communication permitted or required under this
Agreement must be in writing, must refer specifically to this Agreement and will
be deemed given only if delivered by hand, sent by facsimile transmission (with
transmission confirmed), by PDF e-mail attachment with digital return receipt,
or by internationally recognized overnight delivery service that maintains
records of delivery, addressed to the Parties at their respective addresses
specified in Section 10.5.2 or to such other address as the Party to whom notice
is to be given may have provided to the other Party in accordance with this
Section 10.5.1. Such Notice will be deemed to have been given as of the date
delivered by hand, transmitted by facsimile (with transmission confirmed) or by
PDF e-mail attached with digital return receipt, or on the second business day
(at the place of delivery) after deposit with an internationally recognized
overnight delivery service. This Section 10.5.1 is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their obligations under the terms of this Agreement.

 

10.5.2.              Address for Notice.

 

For Ironwood:

 

Ironwood Pharmaceuticals, Inc.

 

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301 Binney Street

Cambridge, MA 02142

United States of America

Attention:  General Counsel

Fax: +1 (617) 494-0480

E-mail: [**]

 

With a copy to:

 

Ropes & Gray LLP

Prudential Tower

800 Boylston Street

Boston, MA 02199-3600

United States of America

Attention:  Marc A. Rubenstein, Esq.

Fax:  +1 (617) 235-0706

E-mail: marc.rubenstein@ropesgray.com

 

For AstraZeneca:

 

AstraZeneca Shanghai Zhangjiang Park

No. 199 Liangjing Road

201203

China

Attention:  Regional Vice President, Asia Pacific (currently Mark Mallon)

 

and

 

1S92, Mereside

Alderley Park, Macclesfield, Cheshire

England

SK10 4TF

Attention:  Deputy General Counsel (currently Liam McIlvenn)

 

With a copy to:

 

Covington & Burling LLP

One Front Street

San Francisco, CA 94111-5356

Attention: Amy L. Toro, Esq.

(415) 591-7086

 

10.6.             Entire Agreement. This Agreement, constitutes the entire
agreement between the Parties with respect to the subject matter of this
Agreement. This

 

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separately with the Commission.

 

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

 

10.7.             Language. Meetings of the JDC, JOC and JCC and all other
meetings between the Parties will be conducted in English. All documents
prepared by one Party hereunder for the purpose of distribution to the other
Party shall be written in English except as otherwise agreed by the Parties in
writing or in any Ancillary Agreement. Any other documents generated by
AstraZeneca or its Affiliates or received by AstraZeneca or its Affiliates and
required to be provided to Ironwood hereunder shall first be translated into
English by or on behalf of AstraZeneca. The Parties shall coordinate regarding
any other translations required in order to conduct activities with respect to
the Licensed Compound and Products hereunder in order to avoid duplicative
effort and expense. The costs and expenses relating to any translation for which
AstraZeneca is responsible under this Section 10.7 or that is required in order
to make Regulatory Submissions in the Territory as contemplated hereunder or
other filings required by Applicable Law [**]. Notwithstanding the foregoing, in
case of non-English language documents that were prepared by way of a certified
translation of an English language document, provision of the original English
language document (and upon request, the applicable certification) shall
constitute a substitute for translation. With regard to particular classes of
documents, the applicable committee hereunder may modify the foregoing
provisions regarding translation as needed by consensus of the Parties’
representatives.

 

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

 

10.9.             Assignment.  Neither Party may assign its rights or delegate
its obligations under this Agreement, in whole or in part without the prior
written consent of the other Party, except that, subject to the other terms of
this Agreement, (a) each Party will always have the right, without such consent,
(i) to perform any or all of its obligations and exercise any or all of its
rights under this Agreement through any of its Affiliates, (ii) on written
notice to the other Party, assign any or all of its rights and delegate or
subcontract any or all of its obligations hereunder to any of its Affiliates,
and (iii) to assign this Agreement in its entirety to a Future Acquirer in
connection with a Change of Control of such Party and (b) Ironwood may, without
such consent, monetize all or a portion of the value of the milestone payments
to which it may be entitled under Section 4.2 and payments it is entitled to
receive under Section 4.2 by assigning to one Third Party (a “Revenue Buyer”)
the right to receive such milestone payments and other payments (a “Monetization
Transaction”), subject to compliance with the following:

 

79

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(A)          Ironwood shall provide to AstraZeneca a copy of the
agreement(s) effecting the Monetization Transaction (or any amendments thereto)
reasonably in advance of execution thereof in order to allow AstraZeneca an
opportunity to confirm that the agreement complies with the provisions of this
Agreement. Ironwood shall also provide AstraZeneca with an executed copy of the
Monetization Transaction and an amendments thereto.  Copies provided pursuant to
this clause (A) may be redacted with respect to information not pertinent to
compliance with this Agreement.

 

(B)          AstraZeneca shall make such payments to the Revenue Buyer as
directed by Ironwood, provided that AstraZeneca is not required under this
Agreement to make payments to more than one account.

 

(C)          Ironwood has put in place adequate and customary confidentiality
provisions at least as stringent as those applicable to Ironwood hereunder
(including a term of confidentiality at least as long as the Term) with the
Revenue Buyer and no Confidential Information disclosed by AstraZeneca to
Ironwood will be disclosed to any of AstraZeneca’s competitors that are engaged
in the business of developing and commercializing pharmaceutical products.

 

(D)          AstraZeneca shall not incur any incremental tax liability as a
result of the Monetization Transaction (other than tax liability Ironwood
reimburses in advance of any payment by AstraZeneca and if not AstraZeneca may
deduct such incremental tax liability from the payments made to the Revenue
Buyer).

 

(E)           Ironwood has not assigned any rights to enforce any provision of
this Agreement to the Revenue Buyer (including the right to audit), provided
that Ironwood’s agreement to exercise its rights hereunder at the direction of a
Revenue Buyer will not be deemed such an assignment.

 

(F)           AstraZeneca is not required to deliver notices or provide reports
directly to the Revenue Buyer and Ironwood shall not disclose any documents that
would cause AstraZeneca to waive attorney-client privilege.

 

(G)          All other provisions set forth in the Monetization Transaction that
would affect AstraZeneca are reasonable and customary.

 

(H)          For clarity, AstraZeneca shall not be required to generate any
additional reports or new information to be provided to the Revenue Buyer and
shall not be required to deliver any reports or information directly to the
Revenue Buyer.

 

(I)            Notwithstanding anything in this Section 10.9, each Party will
remain responsible for any failure to perform on the part of any of its
Affiliates. Any attempted assignment or delegation in violation of this
Section 10.9 will be void.

 

10.10.           No Benefit to Others. The provisions of this Agreement are for
the sole benefit of the Parties and their successors and permitted assigns, and
they will not be

 

80

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

construed as conferring any rights in any other persons except as otherwise
expressly provided in this Agreement.

 

10.11.           Counterparts. This Agreement may be executed in any number of
counterparts, each of which will be deemed an original and all of which taken
together will be deemed to constitute one and the same instrument. An executed
signature page of this Agreement delivered by facsimile transmission, including
signatures in a fixed electronic format such as a PDF, will be as effective as
an original executed signature page.

 

10.12.           Severability. To the fullest extent permitted by Applicable
Law, the Parties waive any provision of law that would render any provision in
this Agreement invalid, illegal or unenforceable in any respect. If any
provision of this Agreement is held to be invalid, illegal or unenforceable, in
any respect, then such provision will be given no effect by the Parties and will
not form part of this Agreement. To the fullest extent permitted by Applicable
Law and if the rights or obligations of any Party will not be materially and
adversely affected, all other provisions of this Agreement will remain in full
force and effect and the Parties will use their best efforts to negotiate a
provision in replacement of the provision held invalid, illegal or unenforceable
that is consistent with Applicable Law and achieves, as nearly as possible, the
original intention of the Parties.

 

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

 

10.14.           Publicity. Notwithstanding Section 5.1.6, the Parties will
issue press release(s) in the form of Exhibit E. The Parties will consult with
each other reasonably and in good faith with respect to the text and timing of
any subsequent press releases relating to this Agreement or the activity
hereunder prior to the issuance thereof, provided that a Party may not
unreasonably withhold consent to such releases, and that either Party may issue
such press releases as it determines, based on advice of counsel, are reasonably
necessary to comply with laws or regulations or for appropriate market
disclosure or which are consistent with information disclosed in prior releases
properly made hereunder.

 

10.15.           Certain Conventions. Any reference in this Agreement to an
Article, Section, subsection, paragraph, clause, Schedule or Exhibit will be
deemed to be a reference to an Article, Section, subsection, paragraph, clause,
Schedule or Exhibit, of or to, as the case may be, this Agreement, unless
otherwise indicated. Unless the context of this Agreement otherwise requires,
(a) all definitions set forth herein will be deemed applicable whether the words
defined are used herein with initial capital letters in the singular or the
plural, (b) the word “will” will be construed to have the same meaning and
effect as the word “shall,” (c) any definition of or reference to any agreement,
instrument or other document herein will be construed as referring to such
agreement, instrument or other document as from time to time amended,
supplemented or otherwise modified (subject to any restrictions on such
amendments,

 

81

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

supplements or modifications set forth herein), (d) any reference herein to any
Person will be construed to include the Person’s successors and assigns, (e) the
word “notice” will mean notice in writing (whether or not specifically stated)
and will include notices, consents, approvals and other written communications
contemplated under this Agreement, (f) provisions that require that a Party, the
Parties or any committee hereunder “agree,” “consent” or “approve” or the like
will require that such agreement, consent or approval be specific and in
writing, whether by written agreement, letter, approved minutes or otherwise
(but excluding e-mail and instant messaging), (g) references to any specific
law, rule or regulation, or article, section or other division thereof, will be
deemed to include the then-current amendments thereto or any replacement or
successor law, rule or regulation thereof and (h) the term “or” will be
interpreted in the inclusive sense commonly associated with the term “and/or”,
(i) words of any gender include each other gender, (j) words such as “herein”,
“hereof” and “hereunder” refer to this Agreement as a whole and not merely to
the particular provision in which such words appear, (k) words using the
singular will include the plural, and vice versa, (l) the words “include,”
“includes” and “including” will be deemed to be followed by the phrase “but not
limited to”, “without limitation”, “inter alia” or words of similar import and
(m) unless “business days” is specified, “days” will mean “calendar days.”

 

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

 

82

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

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

 

 

IRONWOOD PHARMACEUTICALS, INC.

 

ASTRAZENECA AB

 

 

 

By:

/s/ Michael J. Higgins

 

By:

/s/ Jan-Olof Jacke

 

 

 

 

 

Name:

Michael J. Higgins

 

Name:

Jan-Olof Jacke

 

 

 

 

 

Title:

Senior Vice President, Finance

 

Title:

CFO AstraZeneca AB

 

SIGNATURE PAGE TO COLLABORATION AGREEMENT

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT A

 

Initial Development Plan

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT B

 

Supply Agreement Terms and Related Matters

 

I.  Supply Agreement Terms

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

II.  Supply Price Definition

 

“Supply Price” means

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

III.  Supply Price Breakdown

 

(a)           Standard costs

 

The JOC will discuss appropriate standard cost reporting forms and any changes
necessary to the forms below to report substantially the same information.

 

 

 

Dose / market variant
$/pack

 

Dose / market variant
$/pack

API

 

 

 

 

a)   [**]

 

 

 

 

b)   [**]

 

 

 

 

c)   [**]

 

 

 

 

d)   [**]

 

 

 

 

 

 

 

 

 

Formulation

 

 

 

 

e)   [**]

 

 

 

 

f)    [**]

 

 

 

 

g)   [**]

 

 

 

 

h)   [**]

 

 

 

 

i)    [**]

 

 

 

 

 

 

 

 

 

Packaging

 

 

 

 

j)    [**]

 

 

 

 

k)   [**]

 

 

 

 

l)    [**]

 

 

 

 

m)  [**]

 

 

 

 

n)   [**]

 

 

 

 

 

 

 

 

 

Royalty costs included in standard costs (o)

 

 

 

 

 

 

 

 

 

Total cost per pack [**]

 

 

 

 

 

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

 

(b)          Budget for one-off periodic costs for Territory to include:

 

 

 

Q1

 

Q2

 

Q3

 

Q4

 

 

$

 

$

 

$

 

$

[**]

 

 

 

 

 

 

 

 

[**]

 

 

 

 

 

 

 

 

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

(c) Cost of goods trending

 

For each pack:

 

 

 

Current
Year -2
Actual
$/pack

 

Current
Year -1
Actual
$/pack

 

Current
Year
Budget
$/pack

 

Current
Year +1
Forecast
$/pack

 

Current
Year +2
Forecast
$/pack

China market trade

 

 

 

 

 

 

 

 

 

 

China market sample

 

 

 

 

 

 

 

 

 

 

Market A trade

 

 

 

 

 

 

 

 

 

 

Market A sample

 

 

 

 

 

 

 

 

 

 

Market B trade

 

 

 

 

 

 

 

 

 

 

Market B sample

 

 

 

 

 

 

 

 

 

 

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

IV.  Supply Price Estimate

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT C

 

This exhibit provides an illustrative example of the quarterly reconciliation
for the purpose of cash settlement between the Parties, in consideration of the
Collaboration in China.

 

To determine the Reconciliation Report in accordance with Section 4.2.5, each
Party will exchange the information below on a monthly basis (WD+3). Net Sales
must be determined pursuant to Section 1.114, Supply Costs pursuant to
Section 1.160, Procurement Costs pursuant to Section 1.132, Development Expenses
pursuant to Section 1.54, Commercialization Expenses pursuant to Section 1.41
and [**]

 

Within [**] days after the end of each Calendar Quarter, AstraZeneca will then
prepare the Reconciliation Report to reflect the information from both Parties
and determine the cash settlement due to/from each Party.

 

The Parties will issue invoices consistent with Indirect Tax requirements for
any amounts payable, even though the sums may be netted for settlement purposes.

 

In this illustrative example, Ironwood would be entitled to a true-up payment of
[**] from AstraZeneca, representing Ironwood’s share of the Net Sales less share
of Program Expenses as determined by the Collaboration Agreement.

 

[**]

 

[**]

 

*2 — Reconciliation Report to be prepared by AstraZeneca within [**] days after
the end of each Calendar Quarter.

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT D

 

Regulatory Cooperation

 

The following shall apply with respect to filings and communications with
Regulatory Authorities relating to the Products in the Territory:

 

Document/Interaction

 

Rights/Obligations

Artwork and package insert for Products

 

·    Ironwood to provide mock-up artwork and package insert for the Products
(for both clinical and commercial supply), including all amendments and
supplements thereto, to AstraZeneca at least [**] business days prior to
anticipated submission to the applicable Regulatory Authority

·    AstraZeneca to review and provide comments within [**] business days.

·    Ironwood may not unreasonably reject comments provided by AstraZeneca

Clinical trial data

 

·    Subject to JDC review and approval

Clinical trial protocol documents

 

·    Subject to JDC review and approval

Major clinical trial application submissions

 

·    Ironwood to provide AstraZeneca English-language versions of the final
drafts of all clinical trial application documents other than the clinical trial
data and clinical trial protocol documents that are subject to JDC review and
approval, including all amendments and supplements thereto, at least [**]
business days prior to anticipated submission to the applicable Regulatory
Authority

·    AstraZeneca to review and approve English-language versions of the
documents within [**] business days (the remaining [**]business days are for
Chinese translation, proofreading and finalization of the submission materials)

Labeling filings and labeling supplements (including Trade name filings)

 

·    Subject to JDC review and approval

Clinical Study Report

 

·    Subject to JDC review and approval

Clinical summary documents

 

·    Subject to JDC review and approval

Major Import Drug License (IDL) submissions

 

·    Ironwood to provide AstraZeneca English-language versions of the final
drafts of all other IDL documents not otherwise addressed above, including all
amendments and supplements thereto, at least [**] business days prior to
anticipated submission to the

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

 

applicable Regulatory Authority

·    AstraZeneca to review and approve English-language versions of the
documents within [**] business days (the remaining [**] business days are for
Chinese translation, proofreading and finalization of the submission materials)

Communications (written or electronic) from Regulatory Authorities

 

·    Ironwood to provide AstraZeneca a copy of all written or electronic
communications received by Ironwood from any Regulatory Authorities

Responses to Regulatory Authority Questions (written)

 

·    Subject to JDC review and approval unless agreed otherwise by both parties

Post-approval regulatory commitments from Regulatory Authority

 

·    Subject to JDC review and approval

Product risk management plans

 

·    Per Pharmacovigilance Agreement

Safety reports (annual or periodic)

 

·    Per Pharmacovigilance Agreement

Meeting Materials (e.g., briefing documents) for Meetings with Regulatory
Authorities regarding Clinical Trial Applications, IDL applications and other
major Regulatory Meetings

 

·    Meeting Materials are subject to JDC review and approval or JDC delegation
to appropriate personnel

Meetings with Regulatory Authorities

 

·    Party receiving the meeting request to notify other Party within [**]
business days of the initial request

·    AstraZeneca has the right lead the preparation and coordination of the
meetings and participate in the meetings

Inspections by Regulatory Authorities

 

·    If either Party receives notification of an Inspection request from a
Regulatory Authority, that Party must notify the other Party within [**]
business days of the initial request

·    AstraZeneca has the right to be present at any Inspection

Inspection Findings

 

·    Ironwood to provide copies of Inspection Findings to AstraZeneca within
[**] business days of receipt

·    Significant Inspection Findings should be escalated to the JDC

Safety-Related Communications

 

·    Ironwood to provide AstraZeneca copies of safety letters communicated to
Healthcare Professionals (or any other communications relating to safety issues)
outside the Territory within [**] business days

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

The Parties acknowledge and agree that in certain circumstances a shorter review
and comment/approval period by AstraZeneca may be necessary or sufficient to
maintain the regulatory timelines in the Development Plan, in which case the
Parties shall agree to such shorter period as may be reasonably necessary to
maintain the regulatory timelines in the Development Plan; provided, that in any
event AstraZeneca must have a reasonable period of time to provide any
comments/approvals. For all cases not addressed above, the Parties shall agree
on an appropriate review timeline on a case-by-case basis.

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT E

 

Press Release

 

(See Attached)

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Form of AstraZeneca Press Release

 

ASTRAZENECA AND IRONWOOD ANNOUNCE LINACLOTIDE
COLLABORATION FOR CHINA

 

23 October 2012

 

AstraZeneca and Ironwood Pharmaceuticals, Inc. announced today an agreement to
co-develop and co-commercialise Ironwood’s linaclotide in China. Linaclotide is
the first and only guanylate cyclase-C (GC-C) agonist approved by the US Food
and Drug Administration, in August, for irritable bowel syndrome with
constipation (IBS-C) and chronic idiopathic constipation (CIC).

 

In May, Ironwood filed a clinical trial application with the State Food and Drug
Administration in China for a Phase III clinical trial to assess the efficacy
and safety of linaclotide in adult patients suffering from irritable bowel
syndrome with constipation (IBS-C). IBS-C, which is characterised by symptoms of
abdominal pain and constipation, is a chronic and prevalent functional
gastrointestinal disorder in China and there are currently few treatment options
for this condition.

 

“China is one of the fastest growing prescription medicines markets in the world
and linaclotide represents a valuable opportunity to meet the needs of local
patients by providing an innovative new treatment option,” said Mark Mallon,
Regional Vice-President for Asia Pacific and President, AstraZeneca China. “We
are pleased to be collaborating with Ironwood for linaclotide in China, which
capitalises on our leadership in the gastrointestinal sector in the emerging
markets.”

 

Peter Hecht, Ironwood’s Chief Executive Officer, said: “As we continue to
advance our efforts to make linaclotide available to patients around the world,
we are excited about this opportunity to collaborate in China with AstraZeneca,
one of the world’s most successful companies in gastrointestinal medicine.”

 

AstraZeneca and Ironwood are jointly responsible for strategic oversight of the
development and commercialisation of linaclotide in China. AstraZeneca will have
primary responsibility for the local operational execution.

 

Under the terms of the collaboration, AstraZeneca will make an upfront payment
of $25 million to Ironwood and will share the net profits and losses associated
with linaclotide in China, with AstraZeneca carrying 55 percent of each until a
certain specified milestone is achieved, moving to a 50/50 split thereafter.
Ironwood will also be eligible for $125 million in additional commercial
milestone payments contingent on the achievement of certain sales targets.

 

In addition, the companies also announced  today their agreement  that
Ironwood’s sales force of approximately 160 experienced clinical sales
specialists will promote AstraZeneca’s NEXIUM® (esomeprazole magnesium) in the
US. NEXIUM is a leading prescription drug currently approved to treat the
symptoms of gastroesophageal reflux disease (GERD). This agreement will augment
AstraZeneca’s existing interactions with gastroenterologists and primary care
physicians on behalf of NEXIUM and the patients who need it. It will also
provide Ironwood with an opportunity to increase its presence with the key
gastrointestinal physicians in the US.

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

“A large percentage of adult patients who have IBS-C or who have CIC, may also
suffer from GERD,” said Thomas McCourt, Chief Commercial Officer, Senior
Vice-President, Marketing and Sales, Ironwood Pharmaceuticals. “This agreement
provides our experienced clinical sales specialists with the opportunity to
bring two different and effective therapies to physicians for managing
their patients who have these prevalent and troublesome gastrointestinal
disorders.”

 

— ENDS —

 

NOTES TO EDITORS

 

About Linaclotide

 

Linaclotide is a guanylate cyclase-C agonist (GCCA) that is provided as an oral
capsule intended for once-daily administration.

It binds to guanylate cyclase C locally in the intestine, with no measurable
blood plasma concentrations, resulting in an increase in both intracellular and
extracellular concentrations of cyclic guanosine monophosphate (cGMP).
Elevations in intracellular cGMP are believed to stimulate secretion of
intestinal fluid and accelerate gastrointestinal transit resulting in increased
frequency of bowel movements. Elevations in extracellular cGMP are believed to
decrease activity of pain-sensing nerves, which is thought to be responsible for
a reduction in intestinal pain, according to non-clinical models.

 

About Ironwood Pharmaceuticals

 

Ironwood Pharmaceuticals is an entrepreneurial pharmaceutical company dedicated
to the art and science of great drug-making. Ironwood is located in Cambridge,
Mass. To learn more, visit www.ironwoodpharma.com.

 

About AstraZeneca

 

AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by millions
of patients worldwide. For more information please visit: www.astrazeneca.com.

 

ASTRAZENECA CONTACTS

 

Media Enquiries UK

 

 

Esra Erkal-Paler

+44 20 7604 8030

 

Vanessa Rhodes

+44 20 7604 8037

 

 

 

 

Media Enquiries Sweden

 

 

Ann-Leena Mikiver

+46 8 553 260 20

 

 

 

 

Investor Enquiries

 

 

James Ward-Lilley

+44 20 7604 8122  

mob: +44 7785 432613

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Karl Hård

+44 20 7604 8123

mob: +44 7789 654364

Nicklas Westerholm

+44 20 7604 8124

mob: +44 7585 404950

Ed Seage

+1 302 886 4065

mob: +1 302 373 1361

 

 

 

IRONWOOD CONTACTS

 

 

 

 

 

Media Enquiries

 

 

Lisa Buffington

+1 617 374 5103

 

lbuffington@ironwoodpharma.com

 

 

 

 

 

Investor Enquiries

 

 

Meredith Kaya

+1 617374 5082

 

mkaya@ironwoodpharma.com

 

 

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Form of Ironwood Press Release

 

IRONWOOD AND ASTRAZENECA ANNOUNCE LINACLOTIDE
COLLABORATION FOR CHINA

 

CAMBRIDGE, Mass., and LONDON, October 23, 2012 — AstraZeneca and Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today an agreement to co-develop
and co-commercialize Ironwood’s linaclotide in China. Linaclotide is the first
and only guanylate cyclase-C (GC-C) agonist approved by the US Food and Drug
Administration, in August.

 

In May, Ironwood filed a clinical trial application with the State Food and Drug
Administration in China for a Phase III clinical trial to assess the efficacy
and safety of linaclotide in adult patients suffering from irritable bowel
syndrome with constipation (IBS-C). IBS-C, which is characterized by symptoms of
abdominal pain and constipation, is a chronic and prevalent functional
gastrointestinal disorder in China and there are currently few treatment options
for this condition.

 

“China is one of the fastest growing prescription medicines markets in the world
and linaclotide represents a valuable opportunity to meet the needs of local
patients by providing an innovative new treatment option,” said Mark Mallon,
Regional Vice-President for Asia Pacific and President, AstraZeneca China. “We
are pleased to be partnering with Ironwood for linaclotide in China, which
capitalizes on our leadership in the gastrointestinal sector in the emerging
markets.”

 

Peter Hecht, Ironwood’s Chief Executive Officer, said: “As we continue to
advance our efforts to make linaclotide available to patients around the world,
we are excited about this opportunity to collaborate in China with AstraZeneca,
one of the world’s most successful gastrointestinal companies”

 

AstraZeneca and Ironwood are jointly responsible for strategic oversight of the
development and commercialization of linaclotide in China. AstraZeneca will have
primary responsibility for the local operational execution.

 

Under the terms of the collaboration, AstraZeneca will make an upfront payment
of $25 million to Ironwood and will share the net profits and losses associated
with linaclotide in China, with AstraZeneca carrying 55 percent of each until a
certain specified milestone is achieved, moving to a 50/50 split thereafter. 
Ironwood will also be eligible for $125 million in additional commercial
milestone payments contingent on the achievement of certain sales targets.

 

In addition, the companies also announced today their agreement that Ironwood’s
sales force of approximately 160 experienced clinical sales specialists will
promote AstraZeneca’s NEXIUM® (esomeprazole magnesium) in the US. This agreement
will augment AstraZeneca’s existing

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

interactions with gastroenterologists and primary care physicians on behalf of
NEXIUM and the patients who need it. It will also provide Ironwood with an
opportunity to increase its presence with the key gastrointestinal physicians in
the US.

 

“A large percentage of adult patients who have IBS-C or who have CIC, may also
suffer from GERD,” said Thomas McCourt, Chief Commercial Officer, Senior Vice
President, Marketing and Sales, Ironwood Pharmaceuticals. “This agreement
provides our experienced clinical sales specialists with the opportunity to
bring two different and effective therapies to physicians for managing their
patients who have these prevalent and troublesome gastrointestinal disorders.”

 

About Linaclotide

 

Linaclotide is a guanylate cyclase-C agonist (GCCA) that is provided as an oral
capsule intended for once-daily administration.

It binds to guanylate cyclase C locally in the intestine, with no measurable
blood plasma concentrations, resulting in an increase in both intracellular and
extracellular concentrations of cyclic guanosine monophosphate (cGMP).
Elevations in intracellular cGMP are believed to stimulate secretion of
intestinal fluid and accelerate gastrointestinal transit resulting in increased
frequency of bowel movements. Elevations in extracellular cGMP are believed to
decrease activity of pain-sensing nerves, which is thought to be responsible for
a reduction in intestinal pain, according to non-clinical models.

 

About Ironwood Pharmaceuticals

 

Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial pharmaceutical
company dedicated to the art and science of great drugmaking. Ironwood is
located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.

 

This press release contains forward looking statements. Investors are cautioned
not to place undue reliance on these forward-looking statements, including, but
not limited to, the development plans for linaclotide in China, the potential
for linaclotide to be approved for marketing by the State Food and Drug
Administration in China, the commercialization opportunity for linaclotide in
China, the potential for Ironwood to receive sales-related milestones, and the
opportunity for Ironwood to promote NEXIUM in the United States. Each
forward-looking statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied in such
statement. Applicable risks and uncertainties include the risks that
advancements in the linaclotide development program in China do not proceed as
expected, the State Food and Drug Administration in China does not agree with
the Phase III clinical trial design, Ironwood and AstraZeneca are unable to
successfully complete the Phase III clinical trial or to demonstrate the
efficacy of linaclotide in patients in China in order to obtain marketing
authorization, serious adverse events arise in patients that are deemed to be
definitely or probably related to linaclotide treatment, Ironwood and
AstraZeneca are unable to effectively commercialize linaclotide in
China, Ironwood is unable to successfully co-promote NEXIUM in the
U.S., Ironwood or AstraZeneca terminates all or part of the collaboration or
co-promotion arrangement, as well as risks related to the difficulty of
predicting regulatory approvals and the acceptance of and demand for new
pharmaceutical products. Applicable risks also include those that are listed in
Ironwood’s Quarterly Report on Form 10-Q

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

for the quarter ended June 30, 2012, in addition to the risk factors that are
listed from time to time in its Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q and any subsequent SEC filings. Ironwood undertakes no obligation
to update these forward-looking statements to reflect events or circumstances
occurring after this press release. These forward-looking statements speak only
as of the date of this press release. All forward-looking statements are
qualified in their entirety by this cautionary statement.

 

About AstraZeneca

 

AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by millions
of patients worldwide. For more information please visit: www.astrazeneca.com.

 

Ironwood Pharmaceuticals, Inc. Contacts:

 

Media Relations: Lisa Buffington, 617.374.5103, lbuffington@ironwoodpharma.com

Investor Relations: Meredith Kaya, 617.374.5082, mkaya@ironwoodpharma.com

 

AstraZeneca Contacts

 

Media Enquiries UK

 

 

Esra Erkal-Paler

+44 20 7604 8030

 

Vanessa Rhodes

+44 20 7604 8037

 

 

 

 

Media Enquiries Sweden

 

 

Ann-Leena Mikiver

+46 8 553 260 20

 

 

 

 

Investor Enquiries

 

 

James Ward-Lilley

+44 20 7604 8122

mob: +44 7785 432613

Karl Hård

+44 20 7604 8123

mob: +44 7789 654364

Nicklas Westerholm

+44 20 7604 8124

mob: +44 7585 404950

Ed Seage

+1 302 886 4065

mob: +1 302 373 1361

 

SOURCES: Ironwood Pharmaceuticals, Inc. and AstraZeneca

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Schedule 1.104

 

LICENSED COMPOUND

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Schedule 6.2(a)

 

IRONWOOD PATENT RIGHTS

 

Ironwood Ref. No.

 

Title

 

Country

 

Status

 

Application Date

 

Application No.

 

Registration No.

 

Ownership

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IW003PCT1CN1

 

Methods and Compositions for the Treatment of Gastrointestinal Disorders

 

China

 

Registered

 

January 28, 2004

 

200480008533.9

 

200480008533.9

 

Ironwood

IW003PCT1CN2

 

Treatment of Gastrointestinal Disorders

 

China

 

Pending

 

December 30, 2009

 

200910266225.0

 

 

 

Ironwood

IW003PCT1HK1

 

Methods and Compositions for the Treatment of Gastrointestinal Disorders

 

Hong Kong

 

Registered

 

November 23, 2005

 

05110618.6

 

HK1078768

 

Ironwood

IW003PCT2CN1

 

Methods and Compositions for the Treatment of Gastrointestinal Disorders

 

China

 

Pending

 

March 8, 2005

 

200580014557.X

 

 

 

Ironwood

IW003PCT2CN2

 

Methods and Compositions for the Treatment of Gastrointestinal Disorders

 

China

 

Pending

 

March 8, 2005

 

201010527728.1

 

 

 

Ironwood

IW003PCT2HK1

 

Methods and Compositions for the Treatment of Gastrointestinal Disorders

 

Hong Kong

 

Pending

 

March 29, 2007

 

07105714.7

 

 

 

Ironwood

IW057PCT1CN1

 

Stable Solid Formulation of A GC-C Receptor Agonist Polypeptide Suitable for
Oral Administration

 

China

 

Pending

 

August 14, 2009

 

200980140931.9

 

 

 

Ironwood

IW057PCT1CN1HK1

 

Stable Solid Formulation of A GC-C Receptor Agonist Polypeptide Suitable for
Oral Administration

 

Hong Kong

 

Pending

 

August 14, 2009

 

200980140931.9

 

 

 

Ironwood

IW087PCT1CN1

 

Treatments for Gastrointestinal Disorders

 

China

 

Pending

 

February 17, 2011

 

TBD

 

 

 

Ironwood

IW082PCT1

 

Treatment of Constipation-Predominant Irritable Bowel Syndrome

 

PCT

 

Pending

 

September 9, 2011

 

PCT/US2011/051080

 

 

 

[**]

IW099PCT1

 

Linaclotide Formulations

 

PCT

 

Pending

 

August 8, 2011

 

PCT/US2011/047434

 

 

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

--------------------------------------------------------------------------------

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Schedule 6.3

 

CERTAIN EXISTING AZ IN-LICENSED PRODUCTS

 

[**]

 

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