Exhibit 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [**], HAS
BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM
TO IRONWOOD PHARMACEUTICALS, INC. IF PUBLICLY DISCLOSED.

 

Execution Version

 

AMENDED AND RESTATED

 

COLLABORATION AGREEMENT

 

by and between

 

IRONWOOD PHARMACEUTICALS, INC.

 

and

 

AstraZeneca AB

 

Effective Date: October 23, 2012

 

Amendment Date: September 16, 2019

 

 

 

 

table of contents

 

1. DEFINITIONS 2 2. LICENSE GRANT 18   2.1. License to AstraZeneca 18   2.2.
License to Ironwood 19   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 21 3. ASSET
TRANSFER 21   3.1. Asset Transfer 21   3.2. Reserved 21   3.3. Further
Assurances 21   3.4. Maintenance of Purchased Assets Prior to Transfer 21   3.5.
Wrong Pockets 22 4. Governance 22   4.1. Joint Steering Committee 22 5.
DEVELOPMENT, REGULATORY, AND COMMERCIALIZATION 24   5.1. Development 24   5.2.
Regulatory Matters 27   5.3. Supply of Products 29   5.4. Commercialization in
the Territory 31   5.5. Executive Meetings 32   5.6. Publication 32   5.7.
Compliance 33

 

i

 

 

6. CONSIDERATION 33   6.1. Payments under Prior Agreement 33   6.2.
Manufacturing Payments 33   6.3. Non-Contingent Payments 34   6.4. Milestones 34
  6.5. Royalties 34   6.6. Royalty Term 34   6.7. Generic Competition 34   6.8.
[**] 35   6.9. Royalty Reports and Payments 35   6.10. Records and Audits 35  
6.11. Taxes and Withholding 36   6.12. Currency 37   6.13. Country of Payments
37   6.14. Confidentiality 37   6.15. Interest 37 7. COVENANTS 38   7.1.
Confidentiality 38   7.2. Restrictions 41   7.3. [**] 41   7.4. Compliance with
Law 41   7.5. Business Ethics 42   7.6. Standstill Agreement 42   7.7.
Enforcement of Infringing or Counterfeit Goods 44   7.8. Development Data 44  
7.9. Export Restrictions 44   7.10. Existing Agreements 44   7.11. [**] 45 8.
REPRESENTATIONS AND WARRANTIES 46   8.1. Representations and Warranties of Each
Party 46   8.2. Additional Representations, Warranties and Covenants of Ironwood
46   8.3. Additional Representations and Warranties of AstraZeneca 49   8.4.
Representation by Legal Counsel 49   8.5. No Inconsistent Agreements 49   8.6.
Disclaimer 50

 

ii

 

 

9. INTELLECTUAL PROPERTY 50   9.1. Disclosure 50   9.2. Ownership 50   9.3.
Intellectual Property Working Group 51   9.4. Prosecution and Maintenance of
Patent Rights 51   9.5. Trademarks and Domain Names 52   9.6. Enforcement and
Defense of Technology Rights 54   9.7. Third Party Claims 57   9.8. Third Party
Licenses 58   9.9. Patent Marking 58   9.10. Patent Certifications 58   9.11. No
Implied Licenses 59   9.12. Privileged Communications 59   9.13. Registration
and Submission of the Agreement 59 10. TERM AND TERMINATION 60   10.1. Term 60  
10.2. Termination for Cause 60   10.3. Termination for Convenience 61   10.4.
Change of Control 61   10.5. Effects of Termination and Expiration 62   10.6.
Survival of Certain Obligations 66 11. PRODUCT LIABILITY, INDEMNIFICATION, AND
INSURANCE 67   11.1. Indemnification under Prior Agreement 67   11.2.
Indemnification under this Agreement 69   11.3. [**] 72   11.4. Procedure 72  
11.5. Insurance 72   11.6. Liability Limitations 72 12. MISCELLANEOUS 73   12.1.
Governing Law; Jurisdiction; Dispute Resolution 73   12.2. Force Majeure 75  
12.3. Additional Approvals 76   12.4. Waiver and Non-Exclusion of Remedies 76

 

iii

 

 

  12.5. Notices 76   12.6. Entire Agreement 78   12.7. Language 78   12.8.
Amendment 78   12.9. Assignment 78   12.10. [**] 80   12.11. [**] 80   12.12. No
Benefit to Others 80   12.13. Counterparts 80   12.14. Severability 80   12.15.
Further Assurance 80   12.16. Publicity 80   12.17. Certain Conventions 81  
12.18. Relationship of the Parties 81

 

EXHIBITS

 

Exhibit A Manufacturing Invoices Exhibit B 2019 Initial Development Plan

 

SCHEDULES

 

Schedule 1.1.38 Elements of Clinical Design Summary Schedule 1.1.47 Composition
of Matter Patent Rights Schedule 1.1.93 Ironwood Equipment Schedule 1.106
Licensed Compound Schedule 1.1.110 MD-7246 Patent Rights Schedule 1.1.141
Purchased Inventory Schedule 1.1.144 Purchased Regulatory Approvals and
Submissions Schedule 1.1.159 Patents for Existing Product Schedule 5.2.2(a)
Exceptions to Ironwood’s Obligation Regarding Disclosure of Regulatory
Submissions Schedule 5.2.2(b) Exceptions to Ironwood’s Obligation Regarding
Development Activity Updates Schedule 5.3.1(a) Purchase Orders List Schedule
5.3.1(c) Ancillary Supply Services Schedule 5.3.3 [**] Schedule 5.6.1 Exceptions
to AstraZeneca’s Publication Obligation Schedule 8.2 Ironwood Disclosure
Schedule Schedule 8.3 Certain Existing AZ In-Licensed Products Schedule 9.5.2 AZ
Product Trademarks

 

iv 

 

 

AMENDED AND RESTATED COLLABORATION agreement

 

THIS AMENDED AND RESTATED COLLABORATION AGREEMENT, entered into this 16th day of
September, 2019 (the “Amendment Date”) by and between Ironwood Pharmaceuticals,
Inc., a corporation organized under the laws of Delaware (“Ironwood”) and
AstraZeneca AB, a corporation organized under the laws of Sweden
(“AstraZeneca”), hereby amends and restates that certain Collaboration Agreement
(the “Prior Agreement”, and as amended by this amendment, the “Agreement”)
entered into by and between Ironwood and AstraZeneca on the 23rd day of October,
2012 (the “Effective Date”). 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.) effective as of April 30, 2009, as
amended from time to time prior to the Effective Date or in accordance with this
Agreement (the “Allergan Agreement”), under which Ironwood exclusively licensed
to Almirall S.A. certain rights to the Licensed Compound in certain countries
outside of the Forest Territory and the Territory and Ironwood and Almirall S.A.
agreed to collaborate on the development and commercialization of such compound
in such countries, which Allergan Agreement was subsequently novated to Allergan
Pharmaceuticals International Ltd. (“Allergan”) pursuant to a Novation Agreement
dated October 26, 2015.

 

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 certain countries outside of the Forest
Territory and the Territory and Ironwood and Astellas agreed to collaborate on
the development and commercialization of such compound in such countries.

 

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

 

F.       Ironwood and AstraZeneca have entered into the Prior Agreement,
pursuant to which Prior Agreement the Parties have been jointly developing and
commercializing the Products in the Field in the Territory, and the Parties
desire to amend and restate the Prior Agreement as set forth below, in order to,
among other things, permit AstraZeneca to exclusively develop and commercialize
the Products in the Field in the Territory on its own, subject to the terms set
forth below.

 

G.       In connection with the amendment and restatement of the Prior
Agreement, Ironwood and AstraZeneca are entering into a Transition Services
Agreement (the “Transition Services Agreement”) and an agreement among Ironwood,
AstraZeneca and Allergan (the “Tripartite Agreement”), in each case as of the
Amendment Date.

 

1

 

 

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              “2019 Initial Development Plan” is defined in Section 5.1.2(a).

 

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

 

1.3              [**]

 

1.4              “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.

 

1.5              “Agreement” is defined in the Introduction.

 

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

 

1.7              “Allergan Agreement” is defined in Section C of the Recitals.

 

1.8              “Almac” means Almac Pharma Services Limited.

 

1.9              [**]

 

1.10            [**]

 

1.11            “Amendment Date” is defined in the Introduction.

 

2

 

 

1.12            “Ancillary Agreements” means (a) the Existing Supply Agreement,
(b) the Transition Services Agreement, (c) the Tripartite Agreement, (d) the
Bill of Sale, (e) the Quality Assurance Agreement, and (f) the Pharmacovigilance
Agreement.

 

1.13            “Ancillary Supply Services” is defined in Section 5.3.1(c).

 

1.14            “Anti-Corruption Laws” is defined in Section 7.5.1.

 

1.15            “Applicable Law” means all applicable statutes, ordinances,
regulations, rules, or orders of any kind whatsoever of any governmental
authority or Regulatory Authority in the Territory or otherwise having
jurisdiction over any portion of the Parties’ activities under this Agreement,
as amended from time to time.

 

1.16            “Arbitrator” is defined in Section 12.1.3(a).

 

1.17            “Assignment Transaction” is defined in Section 12.11.

 

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

 

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

 

1.20            “AstraZeneca” is defined in the Introduction.

 

1.21            “AstraZeneca Collaboration Patent Rights” is defined in Section
9.4.1.

 

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

 

1.23            “AstraZeneca Indemnified Party” is defined in Section 11.

 

1.24            “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.

 

1.25          “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.

 

3

 

 

1.26            “AstraZeneca Related Party” is defined in Section 7.6.

 

1.27            “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.

 

1.28            “Audited Party” is defined in Section 6.10.

 

1.29            “Auditing Party” is defined in Section 6.10.

 

1.30            “Authorized Recipient” is defined in Section 7.1.1.

 

1.31             “Authorized Representative” is defined in Section 7.5.2.

 

1.32            “Bankruptcy” is defined in Section 10.2.3.

 

1.33            “Bill of Sale” means that certain Bill of Sale and Assignment
and Assumption Agreement entered into as of the Amendment Date.

 

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

 

1.35            “CC” means chronic constipation.

 

1.36            “Change of Control” means, with respect to a Person, any of the
following: (a) the sale or disposition of all or substantially all of the assets
of such Person to a Third Party, (b) 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), (c) 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 (d) the merger or consolidation of such Person with or into
another corporation, other than, in the case of (b) or (d) 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.

 

1.37            “Claim” is defined in Section 12.1.3(a).

 

1.38            “Clinical Design Summary” means, with respect to a clinical
trial, a summary of the design of such clinical trial that will include the
elements set forth in Schedule 1.38.

 

4

 

 

1.39            “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.

 

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

 

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

 

1.42            “Combination” is defined in Section 7.6.

 

1.43            “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.

 

1.44            “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.

 

1.45            “Commercialization Plan” means the high-level strategic
commercialization plan for Products in the Field in the Territory, as such plan
may be updated from time to time. The Commercialization Plan will include a
multi-year marketing strategy and an overview of all other material activities
to be conducted in connection with the Commercialization of Products in the
Field in the Territory, including brand strategy, marketing campaigns and
high-level communications strategy.

 

1.46            “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.

 

1.47            “Composition of Matter Patent” means the Patent Rights in the
Territory set forth on Schedule 1.47, including, with respect to such Patent
Rights, (a) all provisional applications, substitutions, continuations,
continuations-in-part, divisions, renewals, and all patents granted thereon,
(b) 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.

 

5

 

 

1.48            “Confidential Information” means, subject to Sections 7.1.2 and
7.1.3, 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 JSC
(or at a meeting of the JDC, JOC or JCC under the Prior Agreement) will
constitute Confidential Information unless otherwise specified.

 

1.49            “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 9.8 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.

 

1.50            “Corden” means Corden Pharma Colorado, Inc.

 

1.51            “Counterfeiting” is defined in Section 7.7.

 

1.52            “CRO” means a qualified clinical research organization.

 

1.53            “Development” means all activities performed by or on behalf of
AstraZeneca in the performance of the Development Plan or otherwise related to
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, Post-Approval Research, medical-scientific affairs, scientific
publications, obtaining, maintaining or expanding Regulatory Approval and
otherwise handling regulatory affairs, statistical analysis and report writing,
in each case with respect to the Licensed Compound or a Product. Development
will not include Manufacturing or Commercialization. When used as a verb,
“Develop” means to engage in Development.

 

6

 

 

1.54            “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.

 

1.55            “Development Dispute” is defined in Section 5.1.3.

 

1.56            “Development Plan” means the 2019 Initial Development Plan and
any other 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) a
high-level description of non-clinical studies and clinical trials and strategy
for obtaining, maintaining and, if applicable, expanding Regulatory Approvals
for the Products, (c) an expected timetable for the completion of such
non-clinical studies and clinical trials and (d) Clinical Design Summaries to
the extent the Development Plan relates to a clinical trial, as such plan may be
amended or updated from time to time in accordance with this Agreement. Each
Development Plan shall include sufficient detail to permit Ironwood to assess
whether the Development activities described in such plan would have an adverse
impact on the development or commercialization of a Product outside of the
Territory.

 

1.57            “Disclosing Party” is defined in Section 7.1.1.

 

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

 

1.59            “Effective Date” is defined in the Introduction.

 

1.60            [**]

 

1.61            “Existing Agreements” means the Forest Agreement, the Allergan
Agreement and the Astellas Agreement.

 

1.62            “Existing Product” means the immediate release formulation of
the Licensed Compound approved by the National Medical Products Administration
in the People’s Republic of China under the name LINZESS.

 

1.63            “Existing Supply Agreement” means the Supply Agreement by and
between AstraZeneca AB and Ironwood Pharmaceuticals, Inc., dated February 15,
2013, as amended as of the Amendment Date, including all Product Schedules
thereto.

 

7

 

 

1.64            “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 [**].

 

1.65            “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.

 

1.66            “First Commercial Sale” means, (a) with respect to the People’s
Republic of China and Macau, on a country-by-country and Product-by-Product
basis, the first sale of such Product under this Agreement for use in the Field
to a Third Party in such country, after such Product has been granted Regulatory
Approval for use in the Field by the competent Regulatory Authorities and (b)
with respect to Hong Kong, the Amendment Date.

 

1.67            “Force Majeure” is defined in Section 12.2.

 

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

 

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

 

1.70            “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).

 

1.71            “FTE Rate” means the [**] per employee [**]. The FTE Rate will
initially be [**], provided however that such rate may be adjusted from time to
time by mutual agreement of the Parties.

 

1.72            “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.

 

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

 

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

 

1.75            “Generic Competition” means, with respect to a Product and a
country that [**] with respect to such Product are being commercially sold in
such country.

 

1.76            “Generic Product” means, with respect to a Product in a country
in the Territory, a product that [**].

 

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

 

1.78            “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.

 

8

 

 

1.79            “Group” is defined in Section 7.6.

 

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

 

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

 

1.82            “ICC” is defined in Section 12.1.3(a).

 

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

 

1.84            “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 JSC has determined not to pursue
Development for such indication) or any other indication for which a Product is
then being Developed or Commercialized in the Territory pursuant to this
Agreement, unless such entity or such Affiliate ceases such activity or [**].

 

1.85            “Incremental Taxes” is defined in Section 6.11.5.

 

1.86            “Indemnified Party” is defined in Section 11.3.

 

1.87            “Indemnifying Party” is defined in Section 11.3.

 

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

 

1.89            “Infringement” is defined in Section 9.6.2.

 

1.90            “Initial Development Plan” is defined in the Prior Agreement.

 

1.91            “IPWG” is defined in Section 9.3.

 

1.92            “Ironwood” is defined in the Introduction.

 

1.93            “Ironwood Equipment” means the equipment identified in Schedule
1.93.

 

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

 

1.95            “Ironwood Indemnified Party” is defined in Section 11.2(b).

 

9

 

 

1.96            “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 to Develop, Manufacture or Commercialize the
Licensed Compound or Product in the Territory, 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, (b) all clinical, pharmacology, toxicology and other
biological data with respect to the Licensed Compound or a Product to the extent
Controlled by Ironwood or any of its Affiliates during the Term and necessary or
useful to Develop, Manufacture or Commercialize the Licensed Compound or Product
in the Territory, in each case other than Development Data and (c) 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.
Ironwood Know-How includes Reference Standards Know-How.

 

1.97            “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.

 

1.98            “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.

 

1.99            [**]

 

1.100      “JSC” is defined in Section 4.1.1.

 

1.101      “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).

 

1.102      “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.

 

10

 

 

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

 

1.104      “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.

 

1.105      “Liabilities” is defined in Section 11.1(a).

 

1.106      “Licensed Compound” means Ironwood’s proprietary GC-C Agonist
generally referred to as “linaclotide” and having the chemical structure set
forth on Schedule 1.105 and any salts, metabolites, polymorphs and pro-drugs
thereof.

 

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

 

1.108      “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.

 

1.109      “Manufacturing Cutover Date” is defined in Section 5.3.1(a).

 

1.110      “MD-7246” means a delayed release formulation of linaclotide, covered
by the Patent Rights set forth on Schedule 1.109 (including, with respect to
such Patent Rights, (a) all provisional applications, substitutions,
continuations, continuations-in-part, divisions, renewals, and all patents
granted thereon, (b) 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) being
developed by Ironwood outside of the Territory in the Field.

 

1.111      “Milestone Event” is defined in Section 6.4.

 

1.112      “Monetization Transaction” is defined in Section 12.9.

 

11

 

 

1.113      “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 a 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 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.

 

1.114      “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.

 

1.115      “NMPA” is defined in the definition of “Generic Product.”

 

1.116      “Non-Contingent Payments” is defined in Section 6.2.

 

1.117      “Official” is defined in Section 7.5.2.

 

1.118      “OIC” means opioid induced constipation.

 

12

 

 

1.119      “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.

 

1.120      “Order” is defined in Section 7.1.3.

 

1.121       [**]

 

1.122      “Parent” is defined in Section 10.4.2.

 

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 6.11.1.

 

1.126      “Permitted Purpose” is defined in the definition of “Territory.”

 

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

 

1.128      “Pharmacovigilance Agreement” is defined in Section 5.2.4.

 

1.129      “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.

 

1.130      “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.

 

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

 

1.132      “Post-Amendment Period” is defined in Section 11.2(a)(iii).

 

1.133      “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.

 

1.134      “Pre-Amendment Period” is defined in Section 11.1(a).

 

1.135      “Prior Agreement” is defined in the Introduction.

 

13

 

 

1.136      “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, including the Existing
Product and MD-7246. For the avoidance of doubt, (a) “Product” excludes non-Oral
Forms, including intravenous and inhalable forms and (b) different dosage
strengths of a Product shall not be considered separate Products for purposes of
this Agreement.

 

1.137      “Product Domain Name” is defined in Section 9.5.

 

1.138      “Product Trademarks” is defined in Section 9.5.

 

1.139      “Prohibited Payment” is defined in Section 7.5.2.

 

1.140      “Purchased Assets” means all rights and assets that are owned by
Ironwood or any of its Affiliates, including those described in clauses (a)-(f),
in each case (i) to the extent related solely to the Product and the Territory
and (ii) excluding the Ironwood Equipment and any Ironwood Technology, Joint
Technology, Development Data or any other intellectual property rights: (a) the
Purchased Inventory, (b) the Purchased Product Records, (c) the Purchased
Promotional Materials, (d) the Purchased Regulatory Approvals and Submissions,
(e) the Purchased Regulatory Documentation and (f) all claims, actions, demands,
judgments and causes of action of Ironwood and its Affiliates against other
Persons (regardless of whether or not such claims and causes of action have been
asserted by Ironwood or any of its Affiliates) that arise out of or relate to
any of the foregoing, and all rights of indemnity, warranty rights, rights of
contribution, rights to refunds, rights of reimbursement and other rights of
recovery possessed by Ironwood or its Affiliates (regardless of whether such
rights are currently exercisable) that relate to any of the foregoing (a)-(e).

 

1.141      “Purchased Inventory” means the inventory of the Products set forth
on Schedule 1.140.

 

1.142      “Purchased Product Records” means all books and records (other than
the Purchased Regulatory Documentation) to the extent related to the
Development, Manufacture or Commercialization of the Products in the Territory.

 

1.143      “Purchased Promotional Materials” means the final versions of all
sales, marketing, advertising, promotional, disease state and media materials,
sales training materials (including related quizzes and answers), existing
customer lists (including all target lists), other marketing data and materials
(including market research), trade show materials (including displays) and
videos, including materials containing clinical data, in each case if any and to
the extent used for the Commercialization of the Product in the Territory.

 

1.144      “Purchased Regulatory Approvals and Submissions” means the Regulatory
Approvals and the Regulatory Submissions set forth on Schedule 1.143.

 

1.145      “Purchased Regulatory Documentation” means, with respect to the
Products in the Territory, all (a) documentation comprising the Regulatory
Approvals, and all reports, regulatory applications, submissions and filings in
connection therewith and (b) correspondence and reports to the extent related to
the Products in the Territory and necessary to, useful for, or otherwise
limiting the ability to, commercially distribute, sell or market the Products in
the Territory submitted to or received from governmental authorities and, to the
extent related to the Territory, relevant supporting documents with respect
thereto, in each case ((a) and (b)), to the extent owned by Ironwood or any of
its Affiliates; provided that the Purchased Regulatory Documentation shall not
be deemed to include any correspondence, reports, documents or data (i) to the
extent they contain any attorney work product, attorney-client communications
and other items protected by established legal privilege or (ii) to the extent
Applicable Law prohibits their transfer or where transfer thereof would subject
Ironwood or any of its Affiliates to Liability of any material kind or nature.

 

14

 

 

1.146      “Quality Assurance Agreement” means the following quality assurance
agreements for the Product entered into by the Parties under the Prior
Agreement, collectively: (a) Quality Assurance Agreement for the Manufacturing,
Packaging, Storage, Distribution, Complaint Monitoring, and Regulatory Reporting
of China Linzess (Almac Packaging), dated as of July 24, 2019, (b) Quality
Assurance Agreement for the Manufacturing, Packaging, Storage, Distribution,
Complaint Monitoring, and Regulatory Reporting of China Linzess (Wuxi
Packaging), dated as of February 27, 2019, and (c) Quality Assurance Agreement
for Contract Manufacturing/Packaging of Bulk Linaclotide Drug Product, dated as
of May 24, 2016.

 

1.147      “Receiving Party” is defined in Section 7.1.1.

 

1.148      “Reconciliation Report” is defined in the Prior Agreement.

 

1.149      “Reference Standards Activities” is defined in Section 5.3.1(b).

 

1.150      “Reference Standards Know-How” is defined in Section 5.3.1(b).

 

1.151      “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, including, for clarity, the Regulatory Approval for the Product in
Switzerland, 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.

 

1.152      “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.

 

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

 

1.154      “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 a Product in the Field in a particular country,
whether obtained before or after a Regulatory Approval in such 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 approvals, and all proposed labels, labeling, package inserts,
monographs, and packaging for the Product.

 

15

 

 

1.155      “Required Post-Marketing Study” means the post-marketing study
required by the China National Medical Products Administration, the protocol of
which has been provided to the China National Medical Products Administration
prior to the Amendment Date and is identified as [**].

 

1.156      “Responsible Tax Party” is defined in Section 6.11.5.

 

1.157      “Revenue Buyer” is defined in Section 12.9.

 

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

 

1.159      “Royalty Term” means, on a country-by-country and Product-by-Product
basis, the period beginning on the First Commercial Sale of such Product in such
country and continuing until (a) with respect to the Existing Product, the
expiration of the last-to-expire Valid Claim of the Patent Rights set forth on
Schedule 1.158 that claims the Existing Product, (b) with respect to MD-7246,
the expiration of the last-to-expire Valid Claim of the Patent Rights set forth
on Schedule 1.109 that claims MD-7246 and any Ironwood Patent Right or Joint
Patent Right that claims the formulation of MD-7246 or its use and (c) with
respect to any Product other than the Existing Product or MD-7246, the
Composition of Matter Patent and any Ironwood Patent Right or Joint Patent Right
that claims the formulation of such Product or its use (including, in each case
((a)-(c)), with respect to such Patent Rights, (i) all provisional applications,
substitutions, continuations, continuations-in-part, divisions, renewals, and
all patents granted thereon, (ii) reissues, reexaminations and extensions or
restorations by existing or future extension or restoration mechanisms,
including supplementary protection certificates or the equivalent thereof, and
(iii) any other form of government-issued right substantially similar to any of
the foregoing).

 

1.160      “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 [**].

 

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

 

1.162      “Shared Liability Claims” is defined in Section 11.1(a).

 

1.163      “Subject Technology” is defined in Section 9.6.5.

 

16

 

 

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

 

1.165      “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.

 

1.166      “Sued Party” is defined in Section 9.7.2.

 

1.167      “Summary Statement” is defined in the Prior Agreement.

 

1.168      “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.

 

1.169      “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.

 

1.170      “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.

 

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

 

1.172      “Term” is defined in Section 10.1.

 

1.173      “Territory” means (a) the People’s Republic of China, including Hong
Kong and Macau, but excluding Taiwan, and (b) Switzerland, but only to the
extent that [**] (the “Permitted Purpose”) and solely for the Permitted Purpose.
For clarity, (i) the phrase “outside the Territory” includes Switzerland and
(ii) each of the People’s Republic of China, Hong Kong and Macau shall be
considered a separate country.

 

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

 

1.175      “Third Party Claims” is defined in Section 11.1(a).

 

1.176      “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.

 

1.177      “Transition Services Agreement” is defined in Section G of the
Recitals.

 

17

 

 

1.178      “Tripartite Agreement” is defined in Section G of the Recitals.

 

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

 

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

 

1.181      [**]

 

1.182      “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 [**].

 

1.183      “Work-in-Process” is defined in Section 5.3.1(a).

 

1.184      “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 10), exclusive,
nontransferable (except as set forth in Section 12.9 or Section 12.10) 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 (a) to (A)
Develop the Licensed Compound and Products in the Field anywhere in the world
for Commercialization in the Field in the Territory and (B) Commercialize the
Licensed Compound and Products in the Field in the Territory, and (b) to
Manufacture, make or have made the Licensed Compound or Products anywhere in the
world for (x) Development of the Licensed Compound and Products in the Field
anywhere in the world for Commercialization in the Field in the Territory or (y)
Commercialization of the Licensed Compound and Products in the Field in the
Territory; provided that, for clarity, the foregoing license grant with respect
to Switzerland shall be limited to the Permitted Purpose. Notwithstanding the
foregoing, Ironwood reserves the right under the Ironwood Technology and
Ironwood’s interest in the Joint Technology and the Development Data to (i)
subject to Section 5.2.5(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, (ii) develop and commercialize the Licensed Compound and Products in
the Territory outside of the Field, and (iii) commercialize the Licensed
Compound and Products outside of the Territory, in each case ((i) through (iii))
in accordance with any applicable terms of this Agreement. Subject to Section
7.3, [**].

 

18

 

 

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 12.9) 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 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 12.9) 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 12.9) license under the AstraZeneca Technology and
AstraZeneca’s interest in the Joint Technology and Development Data solely 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 and applicable Ironwood
Know-How (including without limitation such data or know-how included in any
Regulatory Submission in or outside the Territory), in each case to the extent
necessary or useful to Develop, Manufacture or Commercialize the Licensed
Compound or Product in the Field in the Territory 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 5.2.5(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 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 in the Territory outside of the Field, and (c)
commercialize the Licensed Compound and Products outside of the Territory, in
each case ((a) through (c)) 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. §
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.

 

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2.5.                                   Use of Third Party Contractors. Subject
to Section 5.2.5(a) and Section 5.4.4, the Existing Supply Agreement and the
Quality Assurance Agreement, (a) AstraZeneca may grant a Sublicense of its
rights under this Agreement to [**] and (b) Ironwood may grant a Sublicense of
its rights under this Agreement to [**].

 

2.6.                                   Sublicensing. Each Party may only
sublicense the rights granted to such Party under this Agreement as provided in
Section 2.1, Section 2.2, Section 2.3, Section 2.4, Section 2.5 and Section 10.5
and in accordance with the provisions of Section 5.2.5(a) and Section 5.4.3. 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.

 

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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 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.ASSET TRANSFER

 

3.1.                                   Asset Transfer. Ironwood shall, and shall
cause its Affiliates to, and does hereby, assign to AstraZeneca all of its
right, title and interest in and to the Purchased Assets and shall transfer, or
shall cause its Affiliates and applicable Third Parties to transfer, to
AstraZeneca (or its designee), free and clear of any encumbrance, lien, or claim
of ownership of any Third Party, the Purchased Assets as of the Amendment Date
or as otherwise set forth in the Transition Services Agreement. AstraZeneca will
use Commercially Reasonable Efforts to commence transfer of the Purchased
Regulatory Approvals and Submissions, no later than [**] with the goal of
completion on or before [**].

 

3.2.                                   [Reserved.]

 

3.3.                                   Further Assurances. From time to time
after the transfer of the Purchased Assets to AstraZeneca in accordance with the
terms of the Transition Services Agreement, and for no further consideration,
Ironwood shall, and shall cause its Affiliates and applicable Third Parties to,
execute, acknowledge and deliver such assignments, transfers, consents,
assumptions and other documents and instruments and take such other commercially
reasonable actions as may reasonably be requested by AstraZeneca to more
effectively assign, convey or transfer to or vest in AstraZeneca and its
designated Affiliates, all right, title and interest in and to the Purchased
Assets.

 

3.4.                                   Maintenance of Purchased Assets Prior to
Transfer. Prior to the transfer of the applicable Purchased Asset to
AstraZeneca, Ironwood shall, and shall cause its Affiliates and applicable Third
Parties to:

 

3.4.1.                                    preserve the Purchased Assets until
such time as such Purchased Assets are transferred to AstraZeneca pursuant to
the Transition Services Agreement, including maintaining the Purchased
Regulatory Approvals and Submissions in the same manner as maintained by or on
behalf of Ironwood in the [**] period prior to the Amendment Date;

 

3.4.2.                                    not take or omit to take any action
that would reasonably be expected to have a material adverse impact on the
Purchased Regulatory Approvals and Submissions;

 

3.4.3.                                    provide AstraZeneca with all benefit
of such Purchased Regulatory Approvals and Submissions and such assistance and
cooperation as is necessary or reasonably requested by AstraZeneca to provide
AstraZeneca or its designee with such benefit;

 

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3.4.4.                                    use all Commercially Reasonable
Efforts to preserve the business relating to the Product in the Territory and
its goodwill and maintain its relations and goodwill with material suppliers,
customers, licensors and licensees and other Persons having material business
relationships with respect thereto, in each case only in the same manner and to
the same extent as is preserved or maintained by Ironwood prior to the Amendment
Date;

 

3.4.5.                                    not commence, compromise or settle any
action, claim, action, suit, audit, assessment, arbitration or proceeding
related to the Purchased Assets; and

 

3.4.6.                                    not agree, commit or offer (in writing
or otherwise) to take any of the actions described in this Section 3.4.

 

AstraZeneca shall reimburse Ironwood’s out-of-pocket expenses associated with
the activities set forth in this Section 3.4 to the extent and on the terms set
forth in the Transition Services Agreement.

 

3.5.                                   Wrong Pockets. If either AstraZeneca or
Ironwood becomes aware that any of the Purchased Assets has not been transferred
to AstraZeneca, it shall promptly notify the other Party in writing and the
Parties shall, as soon as reasonably practicable, take all actions reasonably
necessary to ensure that such property is transferred, with any reasonably
necessary prior Third Party consent or approval, to AstraZeneca. Notwithstanding
anything to the contrary in this Agreement or in the Transition Services
Agreement, this Section 3.4 sets forth AstraZeneca’s sole and exclusive remedy
for Ironwood’s failure to identify or transfer any Purchased Asset to
AstraZeneca under Section 3.1.

 

4.Governance

 

4.1.                                   Joint Steering Committee.

 

4.1.1.                                    Overview. Within 30 days after the
Amendment Date, the Parties will establish a joint steering committee (the
“JSC”). The JSC will oversee and serve as a forum for exchanging data and
information regarding the Development and Commercialization of the Products in
the Territory. The Parties anticipate that the JSC will perform the functions
ascribed to it in Section 4.1.3; provided, however, that the functions and
operations of the JSC 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 or Commercialization of the
Products in the Territory.

 

4.1.2.                                    Membership. The JSC will consist of
two senior representatives from each Party of appropriate seniority and
geographical responsibility, one of each with appropriate expertise in
Development and Commercialization activities. Ironwood and AstraZeneca will each
designate a co-chair for the JSC. The co-chairs of the JSC will be responsible
for calling meetings of the JSC 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 JSC. JSC members must have such expertise as appropriate to
the activities of the JSC. From time to time, the JSC may invite personnel of
the Parties having formulation, development, regulatory, manufacturing,
commercial and other expertise to participate in discussions of the JSC as
appropriate to assist in the activities of the JSC.

 

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4.1.3.                                    Responsibilities. Subject to Section
4.1.1, the JSC’s responsibilities will be:

 

(a)                       subject to Ironwood’s rights under Section 5.1.3,
reviewing any Development Plan (or any updates thereto) for non-clinical and
clinical studies (including Post-Approval Research) of Products in the Territory
conducted by or on behalf of AstraZeneca;

 

(b)                       reviewing AstraZeneca’s regulatory activities and
strategy for the Products in the Territory and the global regulatory strategy
for the Products outside the Territory;

 

(c)                       subject to Sections 5.2.3 and 5.2.4 and any other
applicable terms of this Agreement, facilitating the exchange of data,
information, material or results relating to the Development of Products in the
Territory required to be provided to the JSC pursuant to this Agreement;

 

(d)                       [**], including providing updates on the Development
of Products outside the Territory;

 

(e)                       reviewing and discussing the Commercialization Plan
and high-level summaries of Commercialization activities undertaken by
AstraZeneca in the prior six months, in each case as provided by AstraZeneca
under this Agreement; and

 

(f)                        reviewing and discussing updates on the global brand
strategy for Products provided by Ironwood under this Agreement.

 

4.1.4.                                    Meetings. The JSC will meet at such
frequency as will be established by the Parties (but not less frequently than
twice per Year). The JSC will meet in-person at least once per Year and either
telephonically or by video conference at least once per Year unless the Parties
otherwise agree. In-person meetings of the JSC will alternate between a location
selected by AstraZeneca and a location selected by Ironwood, unless otherwise
agreed upon by the members of the JSC. Meetings of the JSC will be effective
only if at least one representative of each Party is in attendance or
participating in the meeting. JSC members may participate in meetings by
telephone if mutually agreed by the Parties. Each Party will be responsible for
expenses incurred by its employees and its members of the JSC in attending or
otherwise participating in JSC meetings. Each Party will use reasonable efforts
to cause its representatives to attend the meetings of the JSC. 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.

 

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

 

4.1.6.                                    JSC Decision-Making. The JSC shall be
a consultative body and shall not have any independent decision-making authority
unless otherwise agreed to by the Parties.

 

5.DEVELOPMENT, REGULATORY, AND COMMERCIALIZATION

 

5.1.                                   Development.

 

5.1.1.                                    Responsibility. As between the
Parties, AstraZeneca shall have the sole and exclusive right to Develop Products
for Commercialization in the Territory within the Field, in each case at its own
expense and subject to the terms of this Agreement and the then current
Development Plan (including the material and non-material changes thereto made
pursuant to this Agreement) (including the applicable Clinical Design Summary).

 

5.1.2.                                    Development Plan.

 

(a)                       The initial Development Plan is attached hereto as
Exhibit B (the “2019 Initial Development Plan”). In the event that AstraZeneca
adopts a Development Plan other than the 2019 Initial Development Plan with
respect to the Development of any Product in the Territory hereunder,
AstraZeneca shall provide such Development Plan to Ironwood prior to the conduct
of any Development activity under such Development Plan, and, if AstraZeneca
contemplates the conduct of a clinical trial for a Product under such
Development Plan, the Development Plan shall be updated to include a Clinical
Design Summary for such clinical trial prior to the conduct of any clinical
trial under such Development Plan. AstraZeneca shall provide to Ironwood any
material updates to a Development Plan (including each Clinical Design Summary),
in each case setting forth in reasonable detail the completion, commencement,
modification or cessation of any Development activities included in the prior
Development Plan to permit Ironwood to assess whether Development activities
with respect to the Product in the Territory would have an adverse impact on the
development or commercialization of a Product outside of the Territory. Without
limiting the foregoing, for purposes of this Section 5.1.2(a), a “material
update” shall include [**]. No protocol with respect to a clinical trial shall
reflect any material change to the applicable then-current Clinical Design
Summary.

 

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(b)                       Neither AstraZeneca nor its Affiliates nor their
respective sublicensees will Develop the Licensed Compound or any Product in any
manner that is inconsistent with the then-current Development Plan (as described
in clause (a)), and neither AstraZeneca nor its Affiliates nor their respective
sublicensees will conduct any clinical trial under this Agreement in any manner
that is inconsistent with Applicable Law or the terms of the applicable protocol
(provided such protocol is consistent with the then-current Clinical Design
Summary), or if no protocol has been provided with respect to a clinical trial,
with the then-current Clinical Design Summary. Without limiting the foregoing,
neither AstraZeneca nor its Affiliates nor their respective sublicensees will
undertake any Development activities for the Licensed Compound or any Product
set forth in a proposed Development Plan or a proposed update to any Development
Plan (including in a proposed Clinical Design Summary or a proposed update to
any Clinical Design Summary) that is not a then-current Development Plan prior
to the later of (i) [**] following Ironwood’s receipt of such Development Plan
or update under Section 5.1.2(a) and (ii) if there is a Development Dispute with
respect to such Development Plan or update, the date of resolution of such
dispute or exercise of Ironwood’s final decision-making authority in accordance
with Section 5.1.3.

 

(c)                       Upon the reasonable request of Ironwood, AstraZeneca
shall promptly provide Ironwood (i) a copy of each clinical trial protocol with
respect to the Licensed Compound, and each material update thereto; and (ii) a
summary of the correspondence or documentation evidencing any compliance
requirements under any Applicable Laws or other requirements imposed by a
Regulatory Authority regarding a study with respect to a Product.

 

25

 

 

5.1.3.                                    Development Dispute. If Ironwood
determines, in its reasonable discretion, that any Development activity proposed
to be conducted by or on behalf of AstraZeneca under this Agreement, as set
forth in a Development Plan (other than the 2019 Initial Development Plan)
(including any clinical trial set forth in a Clinical Design Summary included in
a Development Plan) or any update thereto, would have an adverse impact on the
development or commercialization of a Product outside of the Territory (a
“Development Dispute”), Ironwood shall notify AstraZeneca and the JSC of such
Development Dispute within [**] of Ironwood’s receipt of such Development Plan
or update, as applicable, and at the request of either Party, such Development
Dispute will be submitted to AstraZeneca’s SVP R&D China of AstraZeneca and
Ironwood’s President or, in each case, his or her designee for resolution. If
Ironwood does not provide notice of a Development Dispute in accordance with the
preceding sentence it will be deemed to have waived its right to object to any
Development activity solely to the extent such activity is set forth in the
applicable Development Plan (including in the applicable Clinical Design
Summary) or update, as applicable. Such executives or their designees will meet
(in person or by teleconference) to attempt in good faith to resolve such matter
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 International and CP China 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 matter 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
consensus cannot be reached following escalation in accordance with this
Section 5.1.3 for such matter, then [**] will have final decision-making
authority with respect to such matter, but shall only exercise such right in
good faith after full consideration of the positions of both Parties and shall
communicate its decision with respect to such Development Dispute to [**] in
writing within 30 days after referral of such Development Dispute to the Chief
Executive Officer of Ironwood and the EVP International and CP China of
AstraZeneca pursuant to the preceding sentence. If Ironwood exercises such final
decision-making authority to prohibit AstraZeneca from conducting the
Development activity that is the subject of the Development Dispute, AstraZeneca
and its Affiliates shall not conduct such Development activity or amend the
applicable Development Plan (including any applicable Clinical Design Summary)
to include such activity unless such activity is required for AstraZeneca to
comply with Applicable Laws or requirements imposed by Regulatory Authorities
and AstraZeneca has provided to Ironwood and the JSC a written explanation of
such requirement and documentation evidencing such requirement. [**]. Ironwood
represents and warrants to AstraZeneca that Ironwood has fulfilled its
obligations to [**] and that any approval required for [**] has been obtained.

 

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5.1.4.                                    Reports of Development Activities.
Subject to Section 5.2.2, each Party will report on any and all Development
activities undertaken by it and its Affiliates in the Territory or outside the
Territory, as applicable, in connection with meetings of the JSC, including by
providing a reasonably detailed summary of all results of clinical studies,
regulatory activities and material Collaboration Know-How generated from such
activities. In addition, each Party will, at the other Party’s expense, make
appropriate scientific and regulatory personnel available to such 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.
Without limiting the generality of the foregoing, in connection with meetings of
the JSC, Ironwood will also keep AstraZeneca reasonably informed on activities
undertaken by Ironwood’s Third Party licensees of Products, including Forest,
Allergan and Astellas, relating to the development of any Product outside of the
Territory, and, if reasonably requested by AstraZeneca at any time, then,
subject to Section 5.2.2, will provide AstraZeneca any and all information
Controlled by Ironwood that would reasonably be expected to have an impact on,
or be necessary or useful for the Development, Manufacture, Commercialization or
other exploitation of, the Product in the Territory, including by providing a
reasonably detailed summary of all results of clinical studies and material
Collaboration Know-How generated from such activities. 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 JSC shall establish, in good faith, the manner and
procedures for disclosing any other Ironwood Know-How relevant to the applicable
activities.

 

5.2.                                   Regulatory Matters.

 

5.2.1.                                    Responsibility For Regulatory
Interactions. Subject to the Transition Services Agreement, as between the
Parties, regulatory strategy for the Products in the Territory and all
decision-making with respect thereto will be determined solely and exclusively
by AstraZeneca. AstraZeneca will conduct all activities relating to obtaining
and maintaining Regulatory Approvals with respect to the Products in the
Territory, including preparing and submitting Regulatory Submissions and
attending meetings with Regulatory Authorities in the Territory, in each case at
its own expense. While Ironwood holds any Regulatory Approvals relating to a
Product in the Territory (or any foreign reference product with respect
thereto), Ironwood will not be required to take any action with respect to any
such Regulatory Submission or Regulatory Approval that Ironwood reasonably
believes violates Applicable Law. Following the completion of the transfer of
such Regulatory Submissions and Regulatory Approvals in accordance with Section
3.1, AstraZeneca will own all right, title, and interest in all Regulatory
Submissions and Regulatory Approvals for Products in the Territory.

 

5.2.2.                                    Regulatory Submissions.

 

(a)                       AstraZeneca will provide Ironwood with copies of all
Regulatory Submissions in the form actually submitted to the applicable
Regulatory Authority, promptly following receipt or submission of such
correspondence. Except as set forth on Schedule 5.2.2(a), Ironwood shall provide
to AstraZeneca copies of all Regulatory Submissions of Ironwood or its Third
Party licensees that are in Ironwood’s possession and Control in the form
actually submitted to Regulatory Authorities for any Product outside the
Territory; [**]

 

27

 

 

(b)                       As part of AstraZeneca’s updates to the JSC pursuant
to Section 4.1.3(b), AstraZeneca will provide Ironwood with a high-level summary
of all substantive regulatory activities undertaken by or on behalf of
AstraZeneca with respect to the Licensed Compound or any Product in the
Territory in the preceding two Calendar Quarters, and plans for regulatory
matters with respect to each Product in the Territory in the then-current
Calendar Quarter and the next three Calendar Quarters, including a high-level
summary of all substantive interactions with Regulatory Authorities relating to
Regulatory Approvals, the Regulatory Submissions, the Licensed Compound and such
Product. In addition to the foregoing, AstraZeneca will provide prompt written
notice to Ironwood of Product regulatory submissions, regulatory correspondence,
regulatory interactions, regulatory approvals, withdrawals, safety-related label
changes, and other matters, in each case that are reasonably likely to have a
significant effect on any Product outside of the Territory. Except as set forth
on Schedule 5.2.2(b), Ironwood will keep AstraZeneca reasonably informed
regarding the status and progress of development activity related to the
Licensed Compound outside the Territory as part of its updates to the JSC
pursuant to Section 4.1.3(b).

 

(c)                       AstraZeneca will provide Ironwood with advance copies
of the first application for Regulatory Approval made in the Territory with
respect to any Product (including, without limitation, MD-7246) that (x) is also
being Developed or Commercialized outside of the Territory and (y) is not the
Existing Product, in each case (i) solely to the extent of any information
regarding the safety of, or the proposed label for, such Product included in
such application and (ii) reasonably in advance of submission to a Regulatory
Authority (and, to the extent such copies are not in English, English-language
versions thereof). AstraZeneca will provide Ironwood with at least [**] to
review and comment on such advance copies; provided, however, that Ironwood will
use Commercially Reasonable Efforts to review any such advance copy in a shorter
period of time if AstraZeneca has kept Ironwood reasonably updated on the
content of the applicable advance copy (including by providing copies of prior
drafts thereof to Ironwood) prior to submitting such advance copy to Ironwood
for review pursuant to this Section 5.2.2(c).

 

5.2.3.                                    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.

 

5.2.4.                                    Adverse Events. The Parties will use
good faith efforts to enter into an amended and restated pharmacovigilance
agreement within 120 days after the Amendment Date, or earlier if required by
Applicable Law, which amended and restated agreement 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. Each Party shall conduct activities designated to
such Party under the Pharmacovigilance Agreement [**].

 

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5.2.5.                                    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 [**]. 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 Products in the
Territory, [**] and (ii) with respect to any non-clinical or clinical studies of
a Product, including Phase IV studies, that are not required for registration or
imposed by a Regulatory Authority in the Territory, [**.] The foregoing rights
of [**].

 

(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.

 

5.3.                                   Supply of Products.

 

5.3.1.                                    General. Beginning on the Amendment
Date, as between the Parties, subject to the remainder of this Section 5.3.1,
AstraZeneca will be solely responsible for the Manufacture and clinical and
commercial supply of Licensed Compounds and Products for the Territory.

 

(a)                       Manufacture of Licensed Compound and Product. Ironwood
shall continue to supply Licensed Compounds and Products for the Territory under
the Existing Supply Agreement until [**] or such earlier date as agreed to by
the Parties (the “Manufacturing Cutover Date”). On or prior to the Manufacturing
Cutover Date, [**]. The Joint Operations Committee (as constituted under the
Existing Supply Agreement) shall coordinate as necessary, and the Parties shall
use Commercially Reasonable Efforts, to transfer Manufacturing responsibility
for the Product from Ironwood to AstraZeneca, which transfer shall occur
effective as of the Manufacturing Cutover Date, and to coordinate the Parties’
responsibilities with respect to purchase orders as described in the immediately
prior sentence. In addition, Ironwood shall transfer title of any Licensed
Compound, Product or work-in-process for the Territory in Ironwood’s possession
on the Manufacturing Cutover Date (“Work-in-Process”) to AstraZeneca, and
AstraZeneca shall reimburse Ironwood’s costs associated with such
Work-in-Process to the extent not covered in the supply of Product under the
Existing Supply Agreement. Without limiting AstraZeneca’s obligations to
reimburse Ironwood’s costs associated with the Work-in-Process in the foregoing
sentence, Schedule 5.3.1(a) sets forth a list of all open purchase orders with
Ironwood’s third party manufacturers as of the Amendment Date.

 

29

 

 

(b)                       Manufacture of Reference Standards. Subject to
Ironwood’s obligation to transfer the Reference Standards Know-How to
AstraZeneca, AstraZeneca shall use Commercially Reasonable Efforts to assume
sole responsibility for the preparation and quality management (including the
appropriate qualification and documentation) of all applicable reference
materials needed for analytical purposes in accordance with applicable quality
standards and the specifications for the applicable Product for the Territory
(the “Reference Standards Activities”) within [**] following the Amendment Date.
In connection with AstraZeneca’s assumption of the sole responsibility for the
Reference Standards Activities, Ironwood agrees to provide AstraZeneca with
Ironwood Know-How that is necessary to conduct the Reference Standards
Activities (the “Reference Standards Know-How”). Ironwood shall remain
responsible for the Reference Standards Activities until such time as
AstraZeneca assumes responsibility for the Reference Standards Activities in
accordance with this Section 5.3.1(b) and AstraZeneca shall reimburse Ironwood
for its reasonable out-of-pocket expenses associated with the Reference
Standards Activities.

 

(c)                       Other Manufacturing Activities. In addition, following
the Amendment Date, as between the Parties, AstraZeneca shall assume
responsibility for all other activities conducted by Ironwood relating to the
supply of Licensed Compound and Product for the Territory, as set forth on
Schedule 5.3.1(c) (the “Ancillary Supply Services”). Ironwood shall continue to
conduct the Ancillary Supply Services until the Manufacturing Cutover Date and
AstraZeneca shall reimburse Ironwood for its out-of-pocket costs associated with
the Ancillary Supply Services to the extent not covered in the supply price for
Product under the Existing Supply Agreement. On the Manufacturing Cutover Date,
AstraZeneca shall assume all of Ironwood’s remaining obligations relating to the
Ancillary Supply Services with Ironwood’s Third Party suppliers.

 

(d)                       [**].

 

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5.3.2.                      Recall. AstraZeneca will inform Ironwood of (a) any
recall or withdrawal of a Product in the Territory that would in each case
reasonably be expected to have a material impact on the Product outside the
Territory and (b) any material recall or material withdrawal of a Product in the
Territory prior to the initiation of such recall or withdrawal [**]. To the
extent not constituting Third Party Claims covered by Section 11.2(a), and
subject to the Existing Supply Agreement, the costs and expenses of any recall
or withdrawal of a Product in the Territory for Product sold during the Term
(even if incurred after the Term) will be [**].

 

5.3.3.                      [**]

 

5.4.                     Commercialization in the Territory.

 

5.4.1.                      Responsibility. As between the Parties, AstraZeneca
will be solely responsible for, and will control, the Commercialization of
Products in the Territory, 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
Products in the Territory. AstraZeneca will be responsible for operating the
Product Domain Names, including the content thereof, subject to the IPWG’s
recommendation and the Parties’ approval of the use of each Product Domain Name
that is not exclusive to the Territory as set forth in Section 9.5.

 

5.4.2.                      Commercialization Updates.

 

(a)               AstraZeneca Updates. Commencing in December 2019 and
thereafter within 30 days following each of June 30 and January 1 of each Year
to the extent of any updates, AstraZeneca will provide the JSC with a high-level
summary regarding its Commercialization activities (including those activities
set forth in the Commercialization Plan) with respect to the Products in the
prior half-Year. Without limiting the foregoing, each such high-level summary
will also [**]. In addition, no less frequently than once each Year, AstraZeneca
will provide the JSC with its then-current Commercialization Plan with respect
to the Products in the Territory. Ironwood may provide comments with respect to
AstraZeneca’s Commercialization strategy through its representatives on the JSC,
which AstraZeneca will consider in good faith.

 

(b)               Ironwood Updates. Within 30 days following each of June 30 and
January 1 of each Year, Ironwood will provide the JSC and AstraZeneca with a
written update regarding its global brand strategy with respect to the Products.
Without limiting the foregoing, Ironwood shall provide the JSC and AstraZeneca
additional written updates of any change to its global brand strategy with
respect to the Products that impacts Commercialization of the Products in the
Territory.

 

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5.4.3.                      Diligence. AstraZeneca will use Commercially
Reasonable Efforts to (a) achieve the First Commercial Sale of each Product in
the Territory (other than in Switzerland) before the later of (i) [**] and (ii)
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 and (b)
Commercialize each Product in the Territory (other than in Switzerland) after
such Regulatory Approval has been received.

 

5.4.4.                      Commercial Sales Organization. If AstraZeneca
desires to utilize a Third Party sales force to detail a 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
(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 7.5) or applicable to
AstraZeneca’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.

 

5.5.                     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 or
Commercialization of Products in the Territory.

 

5.6.                     Publication.

 

5.6.1.                      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 [**] to complete
such review and approval or such shorter period as may reasonably be required by
applicable publication deadlines promptly communicated to such Party. For the
avoidance of doubt, [**]. Except as set forth on Schedule 5.6.1, AstraZeneca
will be afforded the opportunity to review any scientific paper or presentation
with respect to any Product proposed for publication, presentation, or
distribution by Ironwood or its Affiliates or its or their (sub)licensees and
will have no more than [**] to complete such review or such shorter period as
may reasonably be required by applicable publication deadlines promptly
communicated to Ironwood. 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.

 

5.6.2.                      Clinical Study Results. Subject to the [**], the
Parties, [**], will coordinate the disclosure of the initiation and results of
clinical studies performed under this Agreement 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 JSC 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 5.6.1. Ironwood and
the JSC will each have at least 30 days, or such shorter period as may
reasonably be required by applicable regulatory deadlines that are promptly
communicated to Ironwood and the JSC to complete any such review. 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.

 

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5.6.3.                      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.

 

5.6.4.                      [**]

 

5.7.                     Compliance. AstraZeneca will at all times during the
Term, including during the Commercialization of any Product in the Territory,
implement and adhere to quality and compliance standards consistent with
Applicable Law and industry best practices and reasonably acceptable to Ironwood
in connection with the performance of its obligations or exercise of its rights
under this Agreement.

 

6.CONSIDERATION

 

6.1.                     Payments under Prior Agreement.

 

6.1.1.                      General. Notwithstanding anything to the contrary in
this Agreement, each Party will be responsible for all payments that are due and
payable by such Party under the Prior Agreement as of the Amendment Date.
AstraZeneca shall have the right to offset any payment that is due and payable
by Ironwood to AstraZeneca under the Prior Agreement against any Non-Contingent
Payment that is due and payable to Ironwood hereunder except to the extent such
payment is the subject of a good faith dispute under the Prior Agreement.

 

6.1.2.                      Final Summary Statements and Reconciliation Report.
Within the applicable timeframes set forth in the Prior Agreement, each Party
shall submit to the other Party a final Summary Statement, each of which Summary
Statements shall cover any time period prior to the Amendment Date that is not
covered by a prior Summary Statement provided by the applicable Party. As soon
as practicable after the receipt by AstraZeneca of Ironwood’s final Summary
Statement, but in any event within the applicable timeframe set forth in the
Prior Agreement, AstraZeneca will prepare a final Reconciliation Report, which
final Reconciliation Report shall cover any time period prior to the Amendment
Date that is not covered by a prior Reconciliation Report and shall be prepared
in accordance with the terms of the Prior Agreement. The Parties acknowledge and
agree that such final Reconciliation Report will include no more than $[**] in
Commercialization Expenses (as defined in the Prior Agreement) payable by
Ironwood, which amount is comprised of actual Commercialization Expenses payable
by Ironwood for [**]. Based on such final 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 6.15 compounded monthly from
the date such additional amount should have first been paid; provided, however,
that 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 reporting any
information required to prepare the applicable Reconciliation Report. In the
event that a Party fails to make any payment as required pursuant to this
Section 6.1.2, 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 such
offset. For clarity, no Summary Statement or Reconciliation Report shall cover
any time period on or after the Amendment Date, and any expense incurred by a
Party on or after the Amendment Date that would be included in a Summary
Statement or Reconciliation Report had it been incurred by such Party prior to
the Amendment Date will instead be subject to the other terms of this Agreement.

 

6.2.                     Manufacturing Payments. AstraZeneca will pay to
Ironwood the amounts set forth in the invoices attached as Exhibit A hereto
pursuant to the terms of the Existing Supply Agreement.

 

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6.3.                     Non-Contingent Payments. Subject to Section 6.1.1,
AstraZeneca will pay to Ironwood the following one-time, non-contingent,
non-refundable payments (collectively, the “Non-Contingent Payments”) in
accordance with the timeline set forth below:

 

Timeline  Payment (a)   No later than January 31, 2021  $10,000,000 (b)   No
later than January 31, 2023  $10,000,000 (c)   No later than January 31, 2024 
$15,000,000

 

Notwithstanding anything to the contrary in this Agreement, in the event that
the Agreement is terminated or expires prior to the payment of any
Non-Contingent Payment(s), such Non-Contingent Payment(s) shall remain payable
to Ironwood, regardless of the termination or expiration of the Agreement or the
reason for termination.

 

6.4.                     Milestones. 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)   Aggregate Net Sales of all Products in
the Territory during any 12 consecutive months exceeds $[**]  $[**] (b)  
Aggregate Net Sales of all Products in the Territory during any 12 consecutive
months exceeds $ [**]  $[**] (c)   Aggregate Net Sales of all Products in the
Territory during any 12 consecutive months exceeds $[**]  $[**] (d)   Aggregate
Net Sales of all Products in the Territory during any 12 consecutive months
exceeds  $[**]  $[**]

 

Once AstraZeneca has made any particular milestone payment under this Section
6.4, AstraZeneca will not be obligated to make any payment with respect to the
re-occurrence of the same Milestone Event.

 

6.5.                     Royalties. Subject to Sections 6.6 and 6.7, AstraZeneca
will pay Ironwood royalties based on the aggregate Net Sales of all Products
sold by AstraZeneca, its Affiliates or Sublicensees in the Territory during a
Year at the marginal rates set forth in the table below. The obligation to pay
royalties will be imposed only once with respect to the same unit of a Product.

 

Aggregate Annual Net Sales of all Products in the Territory  Royalty Rate
Portion of aggregate annual Net Sales up to $[**]  [**]% Portion of aggregate
annual Net Sales that equals or exceeds $[**] up to $[**]  [**]% Portion of
aggregate annual Net Sales that equals or exceeds $[**] up to $[**]  [**]%
Portion of aggregate annual Net Sales that equals or exceeds $[**]  20%

 

6.6.                     Royalty Term. AstraZeneca will pay royalties to
Ironwood under Section 6.5 with respect to each Product and each country during
the applicable Royalty Term. Upon the expiration of the Royalty Term for each
Product in each country, the license granted to AstraZeneca under Section 2.1
and Section 9.5.4 with respect to such Product in such country will become
fully-paid, perpetual and irrevocable.

 

6.7.                     Generic Competition. In the event that there is Generic
Competition with respect to a Product in a country at any time [**], the Net
Sales with respect to the applicable Product in the applicable country shall be
reduced by [**]% for the purpose of determining royalties payable by AstraZeneca
under Section 6.5 for the remainder of the applicable Royalty Term; provided,
however, that [**].

 

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6.8.                     [**]

 

6.9.                     Royalty Reports and Payments. Beginning on the
Amendment Date and continuing for the remainder of the Royalty Term:

 

6.9.1.                      Within [**] days after the end of each Calendar
Quarter, AstraZeneca will deliver a flash report estimating in good faith on a
Product-by-Product basis: (i) Net Sales in the relevant Calendar Quarter in the
Territory (broken down on a monthly basis), (ii) royalties payable on such Net
Sales, and (iii) a summary of the exchange rate methodology then in use by
AstraZeneca with respect to the Territory.

 

6.9.2.                      Within [**] days after the end of each Calendar
Quarter, AstraZeneca will deliver a final report specifying on a
Product-by-Product basis: (i) Net Sales in the relevant Calendar Quarter in the
Territory (broken down on a monthly basis), (ii) royalties payable on such Net
Sales, and (iii) a summary of the exchange rate methodology then in use by
AstraZeneca with respect to the Territory.

 

All royalty payments due under Section 6.5 for each Calendar Quarter will be due
and payable within [**] days after the end of each Calendar Quarter. For the
avoidance of doubt, the report delivered pursuant to Section 6.9.2 shall be the
report from which Net Sales are determined.

 

6.10.                 Records and Audits. Each Party’s recordkeeping and audit
obligations and rights under the Prior Agreement shall continue until the [**]
anniversary of the Amendment Date. In addition, during the Term of this
Agreement, AstraZeneca will keep and maintain accurate and complete records
regarding Net Sales during the three preceding Years, and each Party will keep
and maintain accurate and complete records with respect to the Summary
Statements and Reconciliation Reports (each as defined in the Prior Agreement)
submitted under Section 6.1.2. Upon 15 days prior written notice from the other
Party (the “Auditing Party”), each 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 the accuracy of, as
applicable, any royalty report submitted by AstraZeneca in accordance with
Section 6.9 (if AstraZeneca is the Audited Party) or any Summary Statement or
Reconciliation Report submitted by the Audited Party under Section 6.1.2. An
examination by a Party under this Section 6.10 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
applicable reports or statements 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 Party with respect to such audit.
If the accounting firm determines that, based on errors in the reports so
submitted, a Reconciliation Report is incorrect, the Parties will promptly
revise the Reconciliation Report. If an audit reveals any underpayment or
overpayment under this Agreement, including pursuant to an incorrect
Reconciliation Report, then any additional amount owed by one Party to the other
will be paid within 30 days after the paying Party’s receipt of the accountant’s
report, along with interest at the annual interest rate as provided in Section
6.15, compounded monthly from the date of the audit report; provided, however,
that no such interest will be payable with respect to any payment owed under
Section 6.1.2 if the errors leading to the final Reconciliation Report provided
under Section 6.1.2 being incorrect were in the Summary Statement provided by
the Party entitled to receive such additional amount. Each audit under this
Section 6.10 shall be conducted at the expense of the Auditing Party, provided
that if an audit reveals any underpayment by the Audited Party of [**] or more
with respect to any Year, then the Audited Party will reimburse the Auditing
Party for the expenses incurred by the Auditing Party in conducting the audit.

 

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6.11.                 Taxes and Withholding.

 

6.11.1.                  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.

 

6.11.2.                  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.

 

6.11.3.                  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 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.

 

6.11.4.                  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. AstraZeneca shall
ensure that AstraZeneca 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. AstraZeneca shall be responsible for
any import clearance, including payment of any import duties and similar
charges, in connection with any Products transferred to AstraZeneca.

 

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6.11.5.                  Gross-Up. To the extent that, due to (a) an assignment
by a Party, (b) any change in a Party’s tax residency, (c) any change by a Party
in the entity that originates or receives the payment, (d) any failure on the
part of a Party to comply with Applicable Law or (e) any change in Applicable
Law that would not have affected the Parties but for a prior assignment or
change described in clauses (a)-(c) above, any Taxes are imposed on a payment
made under this Agreement by one Party to the other Party that were not
otherwise applicable (“Incremental Taxes”), the Party that took such action
resulting in such Incremental Taxes (together with any subsequent successor or
assign, “Responsible Tax Party”) shall be solely responsible for and shall
solely bear the amount of such Incremental Taxes, such that the Party receiving
payments will receive the same net amount it would have received (including, for
the avoidance of doubt, any preexisting entitlements to additional amounts
pursuant to this Section 6.11.5) if no Incremental Taxes were payable.  If the
other Party receives a refund or tax credit in connection with the Incremental
Taxes, then such other Party shall promptly pay the Responsible Tax Party an
amount equal to the amount of such refund or tax credit.

 

6.12.                 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. ‎

 

6.13.                 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 [**].

 

6.14.                 Confidentiality. All financial information of a Party
which is subject to review under this Article 6 will be deemed to be
Confidential Information subject to the provisions of Section 7.1, 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.

 

6.15.                 Interest. Any payment under this Article 6 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 U.S. 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 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 U.S.
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.

 

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7.COVENANTS

 

7.1.                     Confidentiality.

 

7.1.1.                      Confidential Information. Except to the extent
expressly permitted by this Agreement and subject to the provisions of
Sections 7.1.2 and 7.1.3, 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 Joint Know-How or
Development Data, regardless of which Party has disclosed such Confidential
Information.

 

7.1.2.                      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;

 

(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.

 

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7.1.3.                      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 9); provided, however, that reasonable
measures shall be taken to assure confidential treatment of such information, to
the extent such protection is available;

 

(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 7.1, Ironwood
may disclose AstraZeneca’s Confidential Information to (i) Forest, Allergan,
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 is covered by Section
7.1.6 and not this Section 7.1.3(b).

 

(c)               Notwithstanding the provisions of this Section 7.1, [**].

 

39

 

 

7.1.4.                      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.

 

7.1.5.                      Destruction of Confidential Information. Upon the
expiration or earlier termination of this Agreement, except to the extent
necessary or useful to exercise rights or perform obligations that continue
after such expiration or termination, and except as otherwise provided in
Section 10.5, 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.

 

7.1.6.                      Use of Name and Disclosure of Terms. Except as
permitted under Section 12.16, 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 7.1.6 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 7.1.6 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 7.1.6. 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 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.

 

40

 

 

7.1.7.                      Remedies. The Parties acknowledge and agree that the
restrictions set forth in this Section 7.1 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 7.1 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 12.1, in the event of a breach or threatened breach of any
provision of Section 7.1 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 7.1.7 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.

 

7.2.                     Restrictions.

 

7.2.1.                      [Reserved.]

 

7.2.2.                      Reciprocal Non-Compete Provisions.

 

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

 

(b)               Without limitation of Section 7.2.2(a), [**], neither Party
nor any of their respective Affiliates will [**].

 

(c)               Notwithstanding the provisions of Sections 7.2.2(a) and
7.2.2(b), if a Party or any of its Affiliates [**]

 

(d)               For purposes of this Section 7.2.2, references to the
“Territory” shall be deemed to exclude Switzerland.

 

7.3.                     [**].

 

7.4.                     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:

 

7.4.1.                      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.

 

7.4.2.                      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.

 

41

 

 

7.5.                     Business Ethics.

 

7.5.1.                      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”).

 

7.5.2.                      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
Representatives”) is authorized to waive compliance with the provisions of this
Section 7.5 and that each Party will be solely responsible for its compliance
with the provisions of this Section 7.5 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 7.5 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 5.7 will apply.

 

7.6.                     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;

 

42

 

 

(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
7.6(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 7.6.

 

Notwithstanding the foregoing, the provisions of this Section 7.6 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 7.6(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
7.6(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 7.6 will again be applicable, in each case, (y) if
Ironwood terminates such 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 7.6(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.

 

43

 

 

Ironwood [**].

 

Nothing in this Section 7.6 shall preclude discussions or communications of any
kind between AstraZeneca and its Affiliates.

 

7.7.                     Enforcement of Infringing or Counterfeit Goods.
AstraZeneca will, at its own expense, use Commercially Reasonable Efforts to (a)
monitor commercial markets in the Territory (other than Switzerland) 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 a 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 (other than Switzerland) 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.

 

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

 

7.9.                     Export Restrictions. AstraZeneca will not knowingly
sell, export, or distribute, directly or indirectly, any Product or Licensed
Compound 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 Existing Supply Agreement).

 

7.10.                 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 Allergan and (ii) compliance by Forest,
Astellas and Allergan with any corresponding obligations of Forest, Astellas or
Allergan under the Forest Agreement, Astellas Agreement and Allergan 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.

 

44

 

 

7.11.                 Other Linaclotide Partners. [**]

 

7.12.                 Prevention of Facilitation of Tax Evasion.

 

7.12.1.                  In this Section 7.12:

 

(a)               references to ‘committing tax evasion’ shall include:

 

(i)               fraudulently or dishonestly failing to pay any amount of tax
to the relevant tax authority within any applicable time limit for the payment
of such tax without incurring interest or penalties; and

 

(ii)              fraudulently or dishonestly claiming any relief, allowance,
credit, deduction, exemption or set off in respect of any tax (or relevant to
the computation of any income, profits or gains for the purposes of any tax), or
any right to or actual repayment of or saving of tax; and

 

(b)               ‘tax’ or ‘taxation’ means

 

(i)               taxes on gross or net income, profits and gains, and

 

(ii)              all other taxes, levies, duties, imposts, charges and
withholdings of any nature, including any excise, property, wealth, capital,
value added, sales, use, occupation, transfer, franchise and payroll taxes and
any national insurance or social security contributions, together with all
penalties, charges, fees and interest relating to any of the foregoing or to any
late or incorrect return in respect of any of them.

 

7.12.2.                  Each Party represents, warrants and undertakes to the
other that in connection with the performance of its obligations under this
Agreement or with respect to payments from one Party to the other Party under
this Agreement, as applicable:

 

(a)               neither it nor its Affiliates shall commit tax evasion;

 

(b)               neither it nor its Affiliates shall undertake any activities
which would facilitate or otherwise result in another person committing tax
evasion and which would amount to a UK tax facilitation evasion offence or a
foreign tax facilitation evasion offence for the purposes of Part 3 of the UK
Criminal Finances Act of 2017; and

 

(c)               it and its Affiliates shall supervise its employees, agents or
other persons who perform services for them or on their behalf that are in each
case engaged on matters related to this Agreement, in a manner consistent with
its foregoing undertakings.

 

7.12.3.                  Each Party shall promptly report any apparent breach by
it of Section 7.12.2 to the other Party.

 

45

 

 

8.REPRESENTATIONS AND WARRANTIES

 

8.1.                     Representations and Warranties of Each Party. As of
each of the Effective Date and the Amendment 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;

 

(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.

 

8.2.                     Additional Representations, Warranties and Covenants of
Ironwood. Ironwood hereby represents, warrants and covenants to AstraZeneca that
(i) as of the Effective Date, in the case of Sections 8.2(i), (p), (q), and (r),
(ii) as of the Effective Date and the Amendment Date, in the case of Sections
8.2(a), (b), (c), (d), (e), (f), (g), (h), (j), (m), (n), (o), and (s), and
(iii) as of the Amendment Date, in the case of Sections 8.2(k), (l) and (t), and
in each case ((i)-(iii)) except as set forth in Schedule 8.2:

 

(a)               Ironwood has with respect to any Patent Right that has reached
the nationalization stage as of the Effective Date or the Amendment Date, as
applicable, 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 applicable Ironwood Patent Rights listed in Schedule
8.2(a) attached hereto and the ownership of such Ironwood Patent Rights is as
set forth on such Schedule 8.2(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.

 

46

 

 

(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
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, Manufacture or
Commercialization of the Licensed Compound or any Product in the Territory,
except, with respect to clause (ii), as set forth in Schedule 8.2(b)(ii).

 

(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 or the Amendment Date, as
applicable, 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
AstraZeneca 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 any 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, including to its and its
Affiliates’ knowledge, all of the foregoing, in each case, that are necessary to
allow (i) as of the Effective Date, Ironwood and AstraZeneca to file for initial
Regulatory Approvals in the Field in the Territory as contemplated under the
Prior Agreement and (ii) as of the Amendment Date, AstraZeneca to file for
initial Regulatory Approvals in the Field in the Territory as contemplated
hereunder or to maintain the Purchased Regulatory Approvals and Submissions in
the Field in the Territory, other than (in the case of clause (ii)) any
Regulatory Approval, Regulatory Submission or other materials in AstraZeneca’s
possession prior to the Amendment Date. 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, other than all Regulatory
Submissions that have been made by AstraZeneca and all Regulatory Approvals
relating thereto, and all such Regulatory Approvals, Regulatory Submissions,
Referenced Regulatory Filings and Ironwood Know-How made available to
AstraZeneca are true and complete. As of the Effective Date and the Amendment
Date, Ironwood has prepared, maintained and retained all Regulatory Approvals
and Regulatory Submissions, other than those Regulatory Approvals and Regulatory
Submissions prepared, maintained or retained by or on behalf of AstraZeneca,
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.

 

47

 

 

(k)               The Purchased Regulatory Approvals are in full force and
effect and have been duly and validly issued. To Ironwood’s knowledge, no event
has occurred in the three years prior to the Amendment Date that would
reasonably be expected to result in the revocation or termination of any
Purchased Regulatory Approval and Submission. No proceeding is pending or, to
Ironwood’s knowledge, threatened in writing regarding the revocation or
termination of any Purchased Regulatory Approval and Submission. As of the
Amendment Date, neither Ironwood nor its Affiliates has received any written
communication from any Regulatory Authority or other governmental authority
threatening to withdraw or suspend any Purchased Regulatory Approval and
Submission. Neither Ironwood nor any of its Affiliates is in material violation
of the terms of any Purchased Regulatory Approval and Submission.

 

(l)                 As of the Amendment Date (i) Ironwood, or its Affiliates,
owns and has good and valid title to, or valid contract rights in, as
applicable, the Purchased Assets, free and clear of all encumbrances, liens and
claims or ownership of a Third Party, and (ii) the Purchased Inventory is usable
or saleable in the ordinary course of business consistent with past practices of
Ironwood .

 

(m)             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.

 

(n)               Ironwood Controls, as of the Effective Date and the Amendment
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 and the 2019 Initial Development
Plan, as applicable.

 

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

 

(p)               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 (provided that for purposes of this Section 8.2(p)
AstraZeneca or any Affiliate thereof shall not be deemed an agent of Ironwood or
its Affiliate) 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.

 

(q)               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.

 

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(r)                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.

 

(s)                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 and the Amendment Date, as
applicable, 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 and the Amendment Date, as applicable, has been disclosed by Ironwood to
AstraZeneca through such due diligence review. To Ironwood’s knowledge, there
are no material facts or circumstances existing that would reasonably be
expected to serve as a basis for such recall, withdrawal, replacement or safety
notice.

 

(t)                 As of the Amendment Date, Ironwood has not granted any
rights to any Third Party that conflict with AstraZeneca’s ability to seek,
obtain or maintain Regulatory Approval for the Products in the Territory as
contemplated by this Agreement.

 

Notwithstanding the foregoing or anything to the contrary in this Agreement,
neither Ironwood nor its Affiliates shall be liable under this Agreement for any
inaccuracy in or breach of any representation or warranty made as of the
Amendment Date and set forth in Section 8.2 if AstraZeneca or its Affiliate is
aware of such inaccuracy or breach prior to the Amendment Date.

 

8.3.                     Additional Representations and Warranties of
AstraZeneca. AstraZeneca hereby represents, warrants and covenants to Ironwood
that as of the Effective Date and the Amendment 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 (or in this representation and warranty made as of the Amendment
Date, as of the Amendment Date).

 

8.4.                     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 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.

 

8.5.                     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 of this Agreement.

 

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8.6.                     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.

 

9.INTELLECTUAL PROPERTY

 

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

 

9.2.                     Ownership.

 

9.2.1.                      Ownership of Technology. Except as set forth in
Section 9.2.2, 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 12.1.3, provided such arbitration panel will
include at least a single arbitrator who is a specialist in U.S. chemical and
pharmaceutical patent law 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 9.2.1. 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 12.9, or (b) to an
Affiliate.

 

9.2.2.                      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 7.8 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 12.9, or (b) to an Affiliate.

 

9.2.3.                      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 [**].

 

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9.3.                     Intellectual Property Working Group. The Parties have
established 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 (a) 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, (b) review usage instructions for and
recommend for approval by the Parties in accordance with Section 9.5.5 the
Product Trademarks and Domain Names in the Territory and (c) 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. If the members of the IPWG are unable to
agree on any such matter after endeavoring to reach consensus for a period of 30
days, then the provisions of Section 9.5.5 shall apply. 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 9. If there is
no such strategy, then the Party with the primary responsibility for an activity
under this Article 9 will be responsible for developing and implementing the
applicable strategy.

 

9.4.                     Prosecution and Maintenance of Patent Rights.

 

9.4.1.                      Patent Prosecution and Maintenance. Ironwood will be
responsible for the preparation, filing, prosecution and maintenance of the
Ironwood Patent Rights at [**], 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, at [**] expense, 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 Allergan, 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 9.4.1 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.
AstraZeneca acknowledges that Ironwood may share advance copies of proposed
patent filings with respect to the AstraZeneca Collaboration Patent Rights with
Forest to the extent required under the Forest Agreement, provided that Forest
is under an obligation to keep such proposed patent filings in confidence.

 

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9.4.2.                      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 9.4.2 for Joint Patent
Rights [**].

 

9.4.3.                      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
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. 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.

 

9.4.4.                      Patent Term Extensions. Regardless of which Party is
filing, prosecuting and maintaining any Patent Right pursuant to this Article 9,
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 [**], with
reimbursement made to the paying Party within [**] of the other Party’s receipt
from the paying Party of an invoice relating to such payment) 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 9.4.4, the
other Party shall reasonably cooperate in the implementation of such decision.

 

9.5.                     Trademarks and Domain Names.

 

9.5.1.                      Product Trademark. On a Product-by-Product basis,
each Product is to be Commercialized in the Territory under those Trademarks and
using those domain names that have been approved under the Prior Agreement as of
the Amendment Date or, from and after the Amendment Date, are recommended by the
IPWG and approved by the Parties in accordance with Section 9.5.5 with respect
to such Product, after good faith consultation with the Parties’ intellectual
property counsel (each such Trademark, other than AstraZeneca House Marks or
Ironwood House Marks, a “Product Trademark” and each such domain name, other
than those containing an AstraZeneca House Mark or Ironwood House Mark, a
“Product Domain Name”). Notwithstanding the foregoing, 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 Allergan, 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.

 

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9.5.2.                      Ownership. The Parties acknowledge that as of the
Amendment Date, AstraZeneca owns the Product Trademarks set forth on Schedule
9.5.2. The Parties shall cooperate to assign and transfer ownership of the
Product Trademarks set forth on Schedule 9.5.2 to Ironwood or its Affiliate as
promptly as practicable following the Amendment Date, with the costs and
expenses of such assignment and transfer to be [**]. 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 the Party that owns a Product Trademark or
Product Domain Name decides not to file or continue to prosecute, register or
maintain such Product Trademark or obtain or maintain such Product Domain Name
in 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
Product Trademark or Product Domain Name in the Territory to permit the other
Party to carry out such activity. After such notice, the other Party may
undertake such activity on behalf of and in the name of the first Party. The
expenses of the selection, filing, prosecution and maintenance of the Product
Trademarks (including the Product Trademarks set forth on Schedule 9.5.2) 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 9.5.2 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.

 

9.5.3.                      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 IPWG. AstraZeneca will not use the Product Trademarks in a way
that is inconsistent with the trademark usage guidelines and the usage
instructions recommended by the IPWG and approved by the Parties pursuant to
Section 9.5.5 (or previously approved by the JCC (as defined in the Prior
Agreement) under the Prior Agreement). 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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9.5.4.                      Trademark and Domain Name License. To effectuate the
purposes of this Agreement, Ironwood hereby grants to AstraZeneca a royalty
free, exclusive license, to use and display the Product Trademarks and to use
the Product Domain Names in connection with the Commercialization of the
Products in the Territory in accordance with this Section 9.5 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 (other than the Product
Trademarks set forth on Schedule 9.5.2), Product Domain Names and Ironwood House
Marks will inure to the benefit of Ironwood.

 

9.5.5.                      IPWG Decision-Making; Elevation and Dispute
Resolution. Any matter within the jurisdiction of the IPWG requiring approval by
the Parties or with respect to which the IPWG cannot reach consensus in
accordance with Section 9.3 will be submitted to the President of Ironwood and
the SVP Intellectual Property of AstraZeneca or, in each case, his or her
designee for approval. Such executives or their designees will meet (in person
or by teleconference) to attempt in good faith to approve such matter 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 so not approve any such matter
within 15 days, such matter will be referred to the Chief Executive Officer of
Ironwood and the EVP International and CP China of AstraZeneca, 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 matter 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 consensus cannot be reached
following escalation in accordance with this Section 9.5.5 for such matter, then
the matter will not be approved and may be resolved by the Parties pursuant to
the dispute resolution provisions in this Agreement.

 

9.6.                     Enforcement and Defense of Technology Rights.

 

9.6.1.      Monitoring. AstraZeneca will develop procedures for monitoring Third
Party patent submissions in the Territory (other than Switzerland), provided
that the IPWG will have the right to review and comment on such procedures.
AstraZeneca will be responsible for executing such procedures and promptly
reporting any relevant discovered activities or information to Ironwood. The
costs of such execution [**].

 

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9.6.2.      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.

 

9.6.3.      Enforcement and Defense of Product Trademarks and Domain Names.
Subject to Section 7.7, 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 9.6.3, 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 such Product Trademark or Product Domain Name. Irrespective
of which Party controls an action pursuant to this Section 9.6.3, 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 Section 11.1 and Section 11.2.

 

9.6.4.      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 will be borne as follows: If the IPWG, acting reasonably,
recommends that the applicable prosecution or defense action be taken, such
costs [**], and the proceeds of any awards, judgments or settlements obtained in
connection with an Infringement in the Territory will be [**]. If the IPWG does
not recommend that the applicable prosecution or defense action be taken (or did
not act reasonably in recommending the applicable prosecution or defense action
be taken), such costs [**], and the proceeds of any awards, judgments or
settlements obtained in connection with an Infringement in the Territory [**].

 

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9.6.5.      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 9.6.5, 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, but not the obligation, 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 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 9.6.5, 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 and, with respect to any such action, the non-enforcing
Party may select separate counsel of its own choosing at its own expense. 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 Section 11.1 and Section 11.2.

 

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9.6.6.      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 [**].

 

(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 [**].

 

9.7.                     Third Party Claims.

 

9.7.1.                      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.

 

9.7.2.                      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 a Product or use
of a 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 7.7, 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 Section 11.1 or Section 11.2, 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 9.7.2 [**] and the proceeds of any awards,
judgments or settlements obtained in connection with any such suit will [**].

 

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9.8.                     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, (i) [**], in each case, through
counsel of its choosing, to negotiate and obtain a license from such Third Party
if such license is applicable to one or more countries outside the Territory and
(ii) AstraZeneca will have the first right (but not the obligation), in each
case, through counsel of its own choosing, to negotiate and obtain a license
from such Third Party if such license is applicable solely to the Territory;
[**]. If the Party with the first right to negotiate and obtain any such license
elects not to obtain such license, the other Party may through counsel of its
choosing, negotiate and obtain a license from such Third Party. [**].

 

9.9.                     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.

 

9.10.                 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 any 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 9.6.5, 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 9.6.5. Each Party shall cooperate
with the other Party, including joining any action, as described in Section
9.6.5. The costs and recoveries of the Parties under this Section 9.10 [**]. In
the event of a conflict between this Section 9.10 and Section 9.6.5, this
Section 9.10 will control.

 

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9.11.                 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.

 

9.12.                 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.

 

9.13.                 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.

 

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10.TERM AND TERMINATION

 

10.1.                 Term. The term of this Agreement will commence on the
Effective Date and, unless and until terminated as provided in this Article 10,
will continue until the expiration of the last-to-expire Royalty Term (the
“Term”). Upon expiration of this Agreement, all Non-Contingent Payments, to the
extent not paid prior to the effective date of expiration, will become due and
payable to Ironwood as of the effective date of expiration.

 

10.2.                 Termination for Cause.

 

10.2.1.                  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 12.1.2, 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 11.6, termination will not be deemed to
relieve a defaulting party from any liability arising from such default.

 

10.2.2.                  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 a 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 determination following such
discussion, AstraZeneca may terminate this Agreement effective upon written
notice thereof to Ironwood.

 

10.2.3.                  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.

 

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10.3.                 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.

 

10.4.                 Change of Control.

 

10.4.1.                  Change of Control Notice. Each Party will notify the
other in writing, referencing this Section 10.4.1, immediately upon any Change
of Control, and will provide such notice where permitted at least [**] days
prior to the Change of Control.

 

10.4.2.                  Consequences of a Change of Control of AstraZeneca. In
the event that AstraZeneca, AstraZeneca PLC (“Parent”) [**] 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 10.4.2. 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 acquisition by Ironwood upon a termination pursuant to this
Section 10.4.2 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 10.4.2, 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.

 

10.4.3.                  Acceleration of Non-Contingent Payments upon Change of
Control of AstraZeneca. Notwithstanding anything to the contrary in this
Agreement, all Non-Contingent Payments, to the extent not paid prior to the
effective date of any Change of Control of AstraZeneca, will become due and
payable to Ironwood immediately prior to the effectiveness of such Change of
Control, regardless of whether Ironwood terminates this Agreement under Section
10.4.2.

 

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10.5.                 Effects of Termination and Expiration.

 

10.5.1.                  Effects of Termination by Ironwood or by AstraZeneca
for Convenience. If this Agreement is terminated by Ironwood under
Section 10.2.1, 10.2.2, 10.2.3, or 10.4.2, or by AstraZeneca under Section 10.3,
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 any Product (excluding, for clarity, any AstraZeneca
House Marks) and any Product-related 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 of Products in the Territory
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. Further, until the completion of such transition,
AstraZeneca will use Commercially Reasonable Efforts to continue the
Commercialization of the Product(s) in the Territory. In addition, AstraZeneca
will return all Ironwood Confidential Information to Ironwood as set forth in
Section 7.1.5. Ironwood will return all AstraZeneca Confidential Information to
AstraZeneca as set forth in Section 7.1.5; 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);

 

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(e)               Without limiting the foregoing, AstraZeneca will furnish
Ironwood with reasonable cooperation to ensure a smooth transition of clinical
and commercial supply of the Licensed Compound or Products to Ironwood with
respect to the Territory [**];

 

(f)                AstraZeneca will assign to Ironwood all right, title and
interest in and to the Purchased Assets that are owned or Controlled by
AstraZeneca as of the effective date of termination and will transfer to
Ironwood such Purchased Assets promptly following the effective date of
termination;

 

(g)               Sections 10.5.1(a) will be effective upon any such
termination, and Sections 10.5.1(b), 10.5.1(c), 10.5.1(d), 10.5.1(e) and
10.5.1(f) will be effective upon such termination or, in the case of termination
by AstraZeneca pursuant to Section 10.3 or by Ironwood pursuant to Section 10.4,
upon Ironwood’s earlier election following a notice of termination. All
activities performed by AstraZeneca on behalf of Ironwood in this Section 10.5.1
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 10.5.1, 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
10.5.1; and

 

(h)               All Non-Contingent Payments, to the extent not paid prior to
the effective date of any such termination, will become due and payable to
Ironwood as of the effective date of such termination.

 

10.5.2.                  Effects of Termination by AstraZeneca for Ironwood
Material Breach or Insolvency. If AstraZeneca terminates this Agreement pursuant
to Section 10.2.1 or 10.2.3:

 

(a)               All licenses granted by (i) Ironwood to AstraZeneca hereunder,
will terminate, and (ii) 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;

 

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(b)               AstraZeneca will assign to Ironwood, at Ironwood’s cost and
expense, 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 any Product (excluding, for clarity, any
AstraZeneca House Marks) and any Product-related 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 of Products in the Territory
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 six months or shorter if required after
the date of termination of this Agreement to comply with Applicable Law;

 

(c)               Without limiting the foregoing, AstraZeneca will furnish
Ironwood with reasonable cooperation to ensure a smooth transition of clinical
and commercial supply of the Licensed Compound or Products to Ironwood with
respect to the Territory, including by entering into an interim supply agreement
with Ironwood (or its designee), if applicable, containing commercially
reasonable terms and conditions pursuant to which AstraZeneca will supply
Licensed Compound or Products to Ironwood (or its designee) for a reasonable
transition period; provided that, Ironwood (or its designee) is using
Commercially Reasonable Efforts to enter into applicable supply agreements with
Third Party manufacturers of the Licensed Compound or Products;

 

(d)               AstraZeneca will assign to Ironwood, at Ironwood’s cost and
expense, all right, title and interest in and to the Purchased Assets that are
owned or Controlled by AstraZeneca as of the effective date of termination and
will transfer to Ironwood such Purchased Assets promptly following the effective
date of termination;

 

(e)               Ironwood will return all of AstraZeneca’s Confidential
Information to AstraZeneca as set forth in Section 7.1.5; 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);

 

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(f)                All Non-Contingent Payments, to the extent not paid prior to
the effective date of any such termination, will become due and payable to
Ironwood as of the effective date of such termination; and

 

(g)               Neither Party will have any further contractual obligations to
the other hereunder, except (i) as set forth in this Section 10.5.2 or in
Section 10.6 or (ii) with respect to any provisions which survive the
termination of this Agreement by their respective terms or obligations accrued
but remaining outstanding as of the effectiveness of termination.

 

10.5.3.                  Effects of Termination for Safety Reasons. If
AstraZeneca terminates this Agreement for safety reasons pursuant to Section
10.2.2, 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 10.6, 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 7.1.5; provided however, that Ironwood
may retain any such Confidential Information that 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
10.2.2;

 

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(e)               All Non-Contingent Payments, to the extent not paid prior to
the effective date of any such termination, will become due and payable to
Ironwood as of the effective date of such termination; and

 

(f)                If, within [**] years after the effective date of a
termination of this Agreement pursuant to Section 10.2.2, 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 10.3; 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.

 

10.5.4.                  [**]

 

10.6.                 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, 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), 5.3.2 (for Product
sold in the Territory during the Term), 6.2, 6.3 (for clarity, regardless of the
reason for termination), 6.14, 7.1, 8.6, Article 9 (solely with respect to those
provisions relating to Joint Technology or Development Data), Sections 9.2,
9.12, and Articles 10, 11 and 12. In addition to the foregoing, the following
provisions survive expiration of this Agreement for so long as AstraZeneca is
Commercializing any Product following such expiration: Section 9.5.4. 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 (a) any milestone payment be due
hereunder after the date on which a notice of termination is provided hereunder
or (b) expiration or termination of this Agreement relieve AstraZeneca of its
payment obligations under either of Section 6.2 or Section 6.3. In addition,
Sections 6.1, 6.11, 6.12, 6.13 and 6.15 shall apply with respect to payments due
hereunder after expiration or termination of this Agreement.

 

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11.PRODUCT LIABILITY, INDEMNIFICATION, AND INSURANCE

 

11.1.                 Indemnification under Prior Agreement. With respect to any
Third Party Claims arising out of actions or omissions occurring prior to the
Amendment Date, the Parties’ indemnification obligations shall be as follows:

 

(a)                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 Manufacture of the Licensed
Compound or Product for the Territory under the Prior Agreement or the
Commercialization of the Product in the Territory after the Effective Date but
before the Amendment Date (such period, the “Pre-Amendment Period”), including
any (i) 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 Pre-Amendment Period, (ii) any recall or withdrawal of
Product sold in the Territory during the Pre-Amendment Period, or (iii) any
infringement claims brought by any Third Parties in the Territory arising out of
actions or omissions occurring during the Pre-Amendment Period (collectively,
“Shared Liability Claims”), which Shared Liability Claims shall, 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 11.1(b) or
11.1(c), be allocated between the Parties as follows: [**]% to AstraZeneca and
[**]% to Ironwood and the Parties shall make reconciling payments to each other
to give effect to such sharing.

 

(b)               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, an “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:

 

(i)                 any intentional misconduct or negligence on the part of
Ironwood or any of its Affiliates or Sublicensees in performing any activity
contemplated by the Prior Agreement or any Ancillary Agreement (as defined in
the Prior Agreement) (subject to any limitations on indemnification set forth in
such Ancillary Agreement);

 

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(ii)              any Ironwood representation or warranty set forth in the Prior
Agreement or any Ancillary Agreement (as defined in the Prior Agreement)
(subject to any limitations on indemnification set forth in such Ancillary
Agreement) being untrue;

 

(iii)            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 Pre-Amendment Period in support of Development or
Commercialization outside the Territory, including in each case (A) any
violation of Applicable Law in connection with such Development or
Commercialization and (B) personal injury or similar claims arising from the use
of any Products;

 

(iv)             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
prior to the Amendment Date (A) outside the Territory or (B) outside the Field
in the Territory;

 

(v)               any breach by Ironwood of any of its covenants or obligations
under the Prior Agreement or under any Ancillary Agreement (as defined in the
Prior Agreement) (subject to any limitations on indemnification set forth in
such Ancillary Agreement) or (except to the extent due to a breach of this
Agreement by AstraZeneca) under the Existing Agreements during the Pre-Amendment
Period; or

 

(vi)             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 of the Prior Agreement, 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 the Prior Agreement or any Ancillary Agreement
(as defined in the Prior Agreement);

 

except, in each case, to the extent AstraZeneca is obligated to indemnify
Ironwood for such Liabilities pursuant to Section 11.1(c).

 

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(c)               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:

 

(i)                 any intentional misconduct or negligence on the part of
AstraZeneca or any of its Affiliates or Sublicensees in performing any activity
contemplated by the Prior Agreement or any Ancillary Agreement (as defined in
the Prior Agreement) (subject to any limitations on indemnification set forth in
such Ancillary Agreement);

 

(ii)              any AstraZeneca representation or warranty set forth in the
Prior Agreement or any Ancillary Agreement (as defined in the Prior Agreement)
(subject to any limitations on indemnification set forth in such Ancillary
Agreement) being untrue;

 

(iii)            any breach by AstraZeneca of any of its covenants or
obligations under the Prior Agreement or under any Ancillary Agreement (as
defined in the Prior Agreement) (subject to any limitations on indemnification
set forth in such Ancillary Agreement); or

 

(iv)             any exploitation of the Joint Technology or the Development
Data by AstraZeneca or its Affiliates, licensees or Sublicensees during the
Pre-Amendment Period 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 11.1(b).

 

11.2.                 Indemnification under this Agreement after the Amendment
Date. With respect to any Third Party Claims arising out of actions or omissions
occurring on or after the Amendment Date, the Parties’ indemnification
obligations shall be as follows:

 

(a)               Indemnification by Ironwood. Ironwood shall indemnify, defend
and hold harmless the AstraZeneca Indemnified Parties from and against any and
all Third Party Claims to the extent resulting from or arising out of:

 

(i)                 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 (subject to any
limitations on indemnification set forth in such Ancillary Agreement);

 

(ii)              any Ironwood representation or warranty set forth in this
Agreement or any Ancillary Agreement (subject to any limitations on
indemnification set forth in such Ancillary Agreement) being untrue;

 

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(iii)            the Development 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, during the Term after the Amendment Date
(such period, the “Post-Amendment Period”) in support of Development or
Commercialization outside the Territory, including in each case any violation of
Applicable Law in connection with such Development or Commercialization;

 

(iv)             the Manufacture 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, during the Post-Amendment Period in support of Development or
Commercialization outside the Territory, including in each case (A) any
violation of Applicable Law in connection with such Manufacture and (B) personal
injury or similar claims arising from the use of any Products;

 

(v)               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, Allergan and Astellas) or Sublicensees
(A) 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) or (B) after the Amendment Date, (1) outside the Territory or (2)
outside the Field in the Territory;

 

(vi)             any breach by Ironwood of any of its covenants or obligations
hereunder or under any Ancillary Agreement (subject to any limitations on
indemnification set forth in such Ancillary Agreement) or (except to the extent
due to a breach of this Agreement by AstraZeneca) under the Existing Agreements
during the Post-Amendment Period; or

 

(vii)          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 11.2(b).

 

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(b)               Indemnification by AstraZeneca. AstraZeneca shall indemnify,
defend and hold harmless the Ironwood Indemnified Parties from and against any
and all Liabilities arising out of Third Party Claims to the extent resulting
from or arising out of:

 

(i)                 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 (subject to any
limitations on indemnification set forth in such Ancillary Agreement);

 

(ii)              any AstraZeneca representation or warranty set forth in this
Agreement or any Ancillary Agreement (subject to any limitations on
indemnification set forth in such Ancillary Agreement) being untrue;

 

(iii)            any breach by AstraZeneca of any of its covenants or
obligations hereunder or under any Ancillary Agreement (subject to any
limitations on indemnification set forth in such Ancillary Agreement);

 

(iv)             (A) the Development or Manufacturing of the Licensed Compound
or Product for the Territory by AstraZeneca, its Affiliates or Sublicensees
under this Agreement or (B) the Commercialization of any Product in the
Territory by AstraZeneca, its Affiliates or Sublicensees during the
Post-Amendment Period, including any death or bodily injury of any person (or
similar claims);

 

(v)               (A) any recall or withdrawal of Product sold in the Territory
during the Post-Amendment Period or (B) any infringement claims brought by any
Third Parties in the Territory that are based upon underlying facts and
circumstances occurring on or after the Amendment Date, which are the subject of
Section 9.7;

 

(vi)             any exploitation of any Purchased Asset by or on behalf of
AstraZeneca or any of its Affiliates or Sublicensees from and after the transfer
of such Purchased Asset to AstraZeneca, or any and all Liabilities arising out
of Third Party Claims with respect to any Purchased Asset that are based upon
underlying facts and circumstances occurring after the transfer of such
Purchased Asset to AstraZeneca; or

 

(vii)          any exploitation of the Joint Technology or the Development Data
by AstraZeneca or its Affiliates, licensees or Sublicensees during the
Post-Amendment Period for purposes other than exploitation of the Licensed
Compound and Products;

 

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except, in each case, to the extent Ironwood is obligated to indemnify
AstraZeneca for such Liabilities pursuant to Section 11.2(a).

 

11.3.                 [**]

 

11.4.                 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 11. 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 11, 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 11.1 or Section
11.2 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 11.4 and Section 9.7, the
procedures in Article 9 will control.

 

11.5.                 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 11.1 or Section 11.2; provided that [**].

 

11.6.                 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 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 11.6 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 11.1 OR SECTION 11.2 OR (III) ANY
LIABILITY OF EITHER PARTY FOR BREACH OF SECTION 7.1 OR SECTIONS 7.2.1 or 7.2.2.

 

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12.MISCELLANEOUS.

 

12.1.                 Governing Law; Jurisdiction; Dispute Resolution.

 

12.1.1.                  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.

 

12.1.2.                  Dispute Resolution. In the event of a dispute arising
out of or relating to this Agreement other than a matter governed by Section
4.1.6, 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 12.1.3. The Parties acknowledge that (a) the failure of the JSC to reach
consensus on a matter under Section 4.1.6, which failure does not involve a
breach by a Party of its obligations hereunder, will not be deemed a dispute
subject to this Section 12.1.2 or Section 12.1.3 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 12.1.2 or Section 12.1.3 (except to
extent a dispute arises as to whether such Party has exercised such
decision-making authority in accordance with its obligation to use Commercially
Reasonable Efforts hereunder).

 

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12.1.3.                  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 12.1.2 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 the People’s
Republic of 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 the
People’s Republic of 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 11.6. 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 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.

 

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(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.

 

12.2.                 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 12.2, 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 10.5.1 or 10.5.2, as applicable, shall apply as
if such termination was a termination as to which such consequences applied.
Notwithstanding the foregoing, nothing in this Section 12.2 will excuse or
suspend the obligation to make any payment due hereunder in the manner and at
the time provided.

 

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12.3.                 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.

 

12.4.                 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.

 

12.5.                 Notices.

 

12.5.1.                  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 12.5.2 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 12.5.1. 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 12.5.1 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.

 

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12.5.2.                  Address for Notice.

 

For Ironwood:

 

Ironwood Pharmaceuticals, Inc.

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: VP of Alliances & Business Development, AstraZeneca China

E-mail: [**]

 

With a copy to:

 

Covington & Burling LLP

Salesforce Tower, 415 Mission Street, Suite 5400

San Francisco, CA 94105-2533

Attention: Amy L. Toro, Esq.

(415) 591-7086

E-mail: atoro@cov.com

 

and to:

 

AstraZeneca UK Limited

Corporate Legal

1 Francis Crick Ave.

Cambridge

CB2 0AA

England

Attention: Deputy General Counsel

E-mail: legalnotices@astrazeneca.com

 

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12.6.                 Entire Agreement. This Agreement, together with the
Transition Services Agreement and the Tripartite Agreement, constitutes the
entire agreement between the Parties with respect to the subject matter of this
Agreement. This Agreement supersedes all prior agreements, whether written or
oral, with respect to the subject matter of this Agreement. This Agreement
specifically amends and restates the Prior Agreement, and the terms and
provisions of the Prior Agreement in respect of all matters, whether arising
before, on, or after the Amendment Date, except as amended and restated herein,
shall be terminated and of no further force or effect. 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.

 

12.7.                 Language. Meetings of the JSC 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 for JSC
meetings shall be written in English except as otherwise agreed by the Parties
in writing or in any Ancillary Agreement. [**]. Any other documents not covered
above shall be provided in the language in which such document was generated or
received by AstraZeneca without any obligation of AstraZeneca to have such
document translated into English [**]. [**] will be solely responsible for the
costs and expenses relating to any translation that is required in order to make
Regulatory Submissions in the Territory as contemplated hereunder or other
filings required by Applicable Law.

 

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

 

12.9.                 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, (b) AstraZeneca may [**], and
(c) 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 6.4 and
payments it is entitled to receive under Section 6.5 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:

 

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(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 12.9, 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
12.9 will be void.

 

79

 

 

12.10.             [**]

 

12.11.             [**]

 

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

 

12.13.             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.

 

12.14.             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.

 

12.15.             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.

 

12.16.             Publicity. The Parties will consult with each other
reasonably and in good faith with respect to the text and timing of any 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.

 

80

 

 

12.17.             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, 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.”

 

12.18.             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.

 

(Remainder of page left blank; signature page follows)

 

81

 

 

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

 

 

IRONWOOD PHARMACEUTICALS, INC.   ASTRAZENECA AB       By: /s/ Halley Gilbert  
By: /s/ Derek Seaborn           Name: Halley Gilbert   Name: Derek Seaborn      
    Title: Senior Vice President, Corporate Development and Chief Administrative
Officer   Title: VP Head of Sweden Operations

 

[Signature Page to Amended and Restated Collaboration Agreement]

 

 

 

 

EXHIBIT A

 

Manufacturing Invoices

 

[**]

 

 

 

  

EXHIBIT B

 

2019 Initial Development Plan

  

[**]

 

 

 

 

Schedule 1.38

 

ELEMENTS OF CLINICAL DESIGN SUMMARY

 

[**]

 

 

 

Schedule 1.47

 

Composition of Matter Patent RIGHTs

 

[**]

 

 

 

 

Schedule 1.93

 

IRONWOOD EQUIPMENT

  

[**]

 

 

 

 

Schedule 1.106

 

licensed compound

 

[**]

 

 

 

 

 

Schedule 1.110

 

MD-7246 PATENT RIGHTS

 

[**]

 

 

 

 

Schedule 1.141

 

Purchased INVENTORY

 

[**]

  

 

 

 

Schedule 1.144

 

PURCHASED REGULATORY APPROVALS AND SUBMISSIONS

 

[**]

 

 

 

 

Schedule 1.159

 

PATENTS FOR EXISTING PRODUCT

 

[**]

 

 

 

 

Schedule 5.2.2(a)

 

EXCEPTIONS TO IRONWOOD’S OBLIGATION REGARDING DISCLOSURE OF REGULATORY
SUBMISSIONS

 

[**]

   

 

 

 

Schedule 5.2.2(b)

 

EXCEPTIONS TO IRONWOOD’S OBLIGATION REGARDING DEVELOPMENT ACTIVITY UPDATES

 

[**]

  

 

 

 

Schedule 5.3.1(a)

 

PURCHASE ORDERS LIST

  

[**]

 

 

 

 

Schedule 5.3.1(c)

 

ANCILLARY SUPPLY SERVICES

 

[**]

 

 

 

 

Schedule 5.3.3

 

 

[**]

  

 

 

 

Schedule 5.6.1

 

EXCEPTIONS TO ASTRAZENECA’S PUBLICATION OBLIGATION

 

[**]

 

 

 

 

 

Schedule 8.2

 

DISCLOSURE SCHEDULE

 

[**]

 

 

Schedule 8.2(a)

 

Ironwood Patent Rights

 

As of Effective Date:

 

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   [**] [**] [**] [**] [**] [**] [**] [**] [**]

 

 

 

 

As of Amendment Date:

  

Ironwood Ref. No. Title Country Status Application Date Application No.
Registration No. Ownership [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]

  

Schedule 8.2(b)(ii)

 

[**]

 

Schedule 8.2(c)

[**]

 

 

 

 

Schedule 8.3

 

certain existing az in-licensed Products

 

[**]

 

 

 

 

Schedule 9.5.2

 

AZ PRODUCT TRADEMARKS

[**]