EXHIBIT 10.52

 

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

BY AND BETWEEN

 

AMYLIN PHARMACEUTICALS, INC.

 

AND

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED

 

DATED:   OCTOBER 30, 2009

 

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TABLE OF CONTENTS

 

1.

DEFINITIONS

1

 

 

 

 

 

 

2.

GOVERNANCE

17

 

 

 

 

 

3.

DEVELOPMENT

23

 

 

 

 

 

4.

REGULATORY

31

 

 

 

 

 

5.

COMMERCIALIZATION

33

 

 

 

 

 

6.

MANUFACTURING

35

 

 

 

 

 

7.

GRANT OF RIGHTS

36

 

 

 

 

 

8.

PAYMENTS

41

 

 

 

 

 

9.

PAYMENT; RECORDS; AUDITS

46

 

 

 

 

 

10.

CONFIDENTIALITY AND PUBLICATIONS

48

 

 

 

 

 

11.

REPRESENTATIONS, WARRANTIES AND COVENANTS; DISCLAIMER

51

 

 

 

 

 

12.

INTELLECTUAL PROPERTY

56

 

 

 

 

 

13.

TERM; TERMINATION

61

 

 

 

 

 

14.

INDEMNIFICATION

68

 

 

 

 

 

15.

DISPUTE RESOLUTION

70

 

 

 

 

 

16.

MISCELLANEOUS

72

 

 

 

 

 

EXHIBIT A

AMYLIN PATENTS AS OF THE EFFECTIVE DATE

A-1

 

 

 

 

 

EXHIBIT B

DEVELOPMENT PLAN THROUGH [***]

B-1

 

 

 

 

 

EXHIBIT C

ANALOGS OF METRELEPTIN

C-1

 

 

 

 

 

EXHIBIT D

CO-COMMERCIALIZATION AGREEMENT TERMS

D-1

 

 

 

 

 

EXHIBIT E

TAKEDA Y-FAMILY AGONISTS

E-1

 

 

 

 

 

EXHIBIT F

IN-LICENSE AGREEMENTS

F-1

 

 

 

 

 

EXHIBIT G

ROYALTY CALCULATION EXAMPLE

G-1

 

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

THIS LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is
entered into as of October 30, 2009 (the “Effective Date”) by and between TAKEDA
PHARMACEUTICAL COMPANY LIMITED, a company organized under the laws of Japan
(“Takeda”), having a place of business at 1-1, Doshomachi 4-chome, Chuo-ku,
Osaka 540-8645 Japan, and AMYLIN PHARMACEUTICALS, INC., a Delaware corporation
(“Amylin”), having a place of business at 9360 Towne Centre Drive, San Diego, CA
92121 U.S.A. Takeda and Amylin may be referred to herein individually as a
“Party” or collectively as the “Parties.”

 

RECITALS

 

WHEREAS, Amylin is engaged in research, development, manufacture and
commercialization of pharmaceutical products, and is currently engaged in the
development of compounds for treatment of obesity and diabetes in humans;

 

WHEREAS, Takeda is engaged in the research, development and commercialization of
pharmaceutical products; and

 

WHEREAS, Takeda and Amylin desire to enter into a collaborative relationship to
further develop and commercialize Products in the Field (as such terms are
defined below), subject to the terms and conditions set forth herein.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:

 

1.                                      DEFINITIONS

 

Unless specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective meanings set
forth below.

 

1.1          “Affiliate” shall mean any Person controlled by, controlling, or
under common control with a Party.  For the purposes of this definition, the
term “control” (including, with correlative meanings, the terms “controlled by”
and “under common control with”) as used with respect to a Party shall mean the
possession, directly or indirectly, of more than fifty percent (50%) of the
outstanding voting securities of a corporation, or comparable equity interest in
any other type of entity, or otherwise having the power to govern the financial
and the operating policies or to appoint the management of such entity. 
Notwithstanding the foregoing, Takeda Thailand, Ltd. shall be considered an
Affiliate of Takeda.

 

1.2          “Alliance Manager” shall have the meaning set forth in Section 2.4.

 

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1.3          “Alternative Delivery System” shall mean a method for
administration of Product to humans other than injectable administration (e.g.,
pump, nasal, transdermal, sublingual, or oral administration).

 

1.4          “Amgen Agreement” shall mean that certain License Agreement between
Amgen Inc. (“Amgen”) and Amylin, dated February 7, 2006, as amended.

 

1.5          “Amylin Compound Related Inventions” shall have the meaning set
forth in Section 12.1.1.

 

1.6          “Amylin Indemnitee” shall have the meaning set forth in
Section 14.1.

 

1.7          “Amylin Know-How” shall mean Information not included in the Amylin
Patents that Amylin Controls on the Effective Date or during the Term, which
Information is necessary or useful to develop, make, have made, distribute, use,
offer for sale, sell, import, export or otherwise Commercialize the Amylin
Licensed Compounds and Products in the Field in the Territory, including any
replication or any part of such Information and including information and
know-how that Amylin Controls on the Effective Date or during the Term which is
necessary or useful to conduct research on the Licensed Compounds and Products
in the Field in the Territory in support of Development and Commercialization
activities as contemplated by this Agreement (but excluding assays, computer
programs, materials or other research tools).

 

1.8          “Amylin Licensed Compound” shall mean any of the following
compounds: (i) Pramlintide (AC137); (ii) Metreleptin (AC164594) and the analogs
thereof listed on Exhibit C; (iii) Davalintide (AC2307); (iv) OPT (AC163954);
and (v) any Option Compound.

 

1.9          “Amylin Patents” shall mean all Patents that Amylin Controls as of
the Effective Date or during the Term, which Patents are necessary or useful to
research, develop, make, have made, distribute, use, offer for sale, sell,
import, export or otherwise Commercialize the Amylin Licensed Compounds and
Products in the Field in the Territory, but excluding Joint Patents.  The Amylin
Patents as of the Effective Date are set forth on Exhibit A.

 

1.10        “Amylin Technology” shall mean the Amylin Know-How and Amylin
Patents.

 

1.11        “Analog” shall mean, with respect to any Amylin Licensed Compound
identified in Section 1.8(i), (ii), (iii) or (iv) or any Takeda Y-family
Agonist, as applicable, any peptide that meets each of the following conditions:
(i) the sequence of such peptide was derived from such Amylin Licensed Compound
or Takeda Y-family Agonist by insertions of, or substitutions by, one or more
naturally-occurring amino acids and/or by deletions from the amino acid sequence
of such Amylin Licensed Compound or Takeda Y-family Agonist, and such peptide
maintains [***] sequence identity with the amino acid sequence of such Amylin
Licensed Compound or Takeda Y-family Agonist, as applicable; and (ii) (a) with
regard to any such Amylin Licensed Compounds that are Y-family analogs or any
Takeda Y-family Agonist, such peptide binds to any of the [***], (b) with regard
to any such Amylin Licensed Compounds that are amylin family analogs, such
peptide binds to any of the [***], and (c) with regard to any such Amylin
Licensed Compounds that are metreleptin analogs, such peptide binds to the
[***]. Notwithstanding the foregoing, Analogs shall not include (1) any peptide
hybrid molecule that

 

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combines two (2) or more peptide modalities, which peptide modalities elicit
their pharmacological effects through distinctly different receptors or receptor
families, into a single molecular entity, or (2) [***]  as of the Effective
Date; provided, however, both Parties agree that to the extent additional
Analogs may be selected for development under the [***], such Analogs shall be
included in this Section 1.11 and subject to the terms and conditions of this
Agreement.

 

1.12        “Applicable Laws” shall mean all applicable statutes, ordinances,
regulations, rules, or orders of any kind whatsoever of any governmental
authority, including the U.S. Food, Drug and Cosmetic Act, (21 U.S.C. §301 et
seq.), Prescription Drug Marketing Act, the Generic Drug Enforcement Act of 1992
(21 U.S.C. §335a et seq.), U.S. Patent Act (35 U.S.C. §1 et seq.), Federal Civil
False Claims Act (31 U.S.C. §3729 et seq.), and the Anti-Kickback Statute
(42 U.S.C. §1320a-7b et seq.), all as amended from time to time, together with
any rules, regulations, and compliance guidance promulgated thereunder.

 

1.13        “Auditor” shall have the meaning set forth in Section 3.12.

 

1.14        “Bankruptcy Laws” shall have the meaning set forth in Section 13.6.

 

1.15        “BID Product” shall mean any Product formulated for twice daily
(BID) injectable administration in a single injection delivery mechanism.

 

1.16        “Binding Budget” shall mean a Development Budget that is intended to
be binding upon the Parties.

 

1.17        “Cardiovascular Indication” shall mean any indication included in
Section 1.51(iii).

 

1.18        “cGCP” shall mean the then current good clinical practices as
defined in U.S. Regulations 21 CFR §§ 50, 54, 56, 312 and 314, (or in the case
of jurisdictions outside the United States, comparable regulatory standards),
and in any successor regulation.

 

1.19        “cGLP” shall mean the then current good laboratory practice
standards promulgated or endorsed by the FDA (or in the case of jurisdictions
outside the United States, comparable regulatory standards).

 

1.20        “cGMP” or “GMP” shall mean current good manufacturing practices for
pharmaceuticals as described in regulations promulgated by Regulatory
Authorities applicable to the manufacture of a Licensed Compound or Product, as
such regulations are in effect at the time of manufacturing such Licensed
Compound or Product, including current Good Manufacturing Practices as defined
under 21 CFR part 210 and 211, and Volume 4 Rules Governing Medicinal Products
in the EU Part I and II (or in the case of jurisdictions outside the United
States and European Union, comparable regulatory standards), as amended from
time to time.

 

1.21        “Change of Control” shall have the meaning set forth in
Section 16.3(b).

 

1.22        “Claim” shall have the meaning set forth in Section 14.1.

 

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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

1.23        “Clinical Trial” shall mean a clinical research trial in humans in
any country that is a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3
Clinical Trial, Phase 4 Clinical Trial, Post-Approval Clinical Trial or
Regulatory Approval Clinical Trial.

 

1.24        “Combination Product” shall have the meaning set forth in
Section 1.80.

 

1.25        “Co-Commercialization Agreement” shall have the meaning set forth in
Section 5.3.

 

1.26        “Co-Commercialization Option” shall have the meaning set forth in
Section 5.3.

 

1.27        “Commercialization” or “Commercialize” shall mean the conduct of all
activities undertaken before and after Regulatory Approval relating to the
promotion, marketing, sale and distribution (including importing, exporting,
transporting, customs clearance, warehousing, invoicing, handling and delivering
Products to customers) of Products in the Field in the Territory, including:
(i) sales force efforts, detailing, advertising, medical education, planning,
marketing, sales force training, and sales and distribution; (ii) scientific and
medical affairs; (iii) Post-Approval Clinical Trials; (iv) all activities
relating to manufacturing Licensed Compounds or Products for commercial sale,
including formulation, delivery technologies and devices, bulk production,
fill/finish, manufacturing process development, and manufacturing and quality
assurance technical support; and (v) all activities relating to maintaining
Regulatory Approval of a Product.

 

1.28        “Commercialization Costs” shall mean those costs and expenses
incurred by a Party, or for its account, after the Effective Date related to the
Commercialization of Products.  Commercialization Costs include Product-specific
Third Party costs and any costs associated with Third Party product liability
claims that arise after Regulatory Approval, but do not include: (i) internal
personnel costs, other than Amylin’s internal personnel costs as contemplated
under Section 5.1 if Amylin performs Commercialization activities at Takeda’s
request; (ii) certain costs set forth in Exhibit D (Co-Commercialization
Agreement), or in the Co-Commercialization Agreement, if any; (iii) Product
Liabilities (as defined in Section 1.100); and (iv) any losses, damages, fees,
costs and other liabilities incurred by a Party as a result of such Party’s
negligence, gross negligence, willful misconduct or breach of such Party’s
representations and warranties made hereunder, and any such losses, damages,
fees, costs and other liabilities will be treated as the sole and exclusive
responsibility of the Party whose actions or omissions gave rise to such losses,
damages, fees, costs and other liabilities.

 

1.29        “Commercialization Plan” shall have the meaning set forth in
Section 5.2.

 

1.30        “Commercially Reasonable Efforts” shall mean, with respect to the
efforts to be expended, or considerations to be undertaken, by a Party or its
Affiliate with respect to any objective, activity or decision to be undertaken
hereunder, reasonable, good faith efforts to accomplish such objective, activity
or decision as such Party would normally use to accomplish a similar objective,
activity or decision under similar circumstances, it being understood and agreed
that with respect to the Development or Commercialization of a Licensed Compound
or Product, such efforts and resources shall be consistent with those efforts
and resources commonly used by a Party for a similar pharmaceutical product
owned by it or to which it has

 

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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

similar rights, which product is at a similar stage in its development or
product life and is of similar market potential taking into account efficacy,
safety, approved labeling, the competitiveness of alternative products sold by
Third Parties in the marketplace, the patent and other proprietary position of
the product, the likelihood of regulatory approval given the regulatory
structure involved, the profitability of the product taking into consideration,
among other factors, Third Party costs and expenses including the royalties,
milestone and other payments payable to licensors of patent or other
intellectual property rights, and the pricing and reimbursement relating to the
product. Commercially Reasonable Efforts shall be determined on a
market-by-market and indication-by-indication basis for a particular Licensed
Compound or Product, and it is anticipated that the level of effort will change
over time, reflecting changes in the status of the Licensed Compound or Product
and the market(s) involved. Notwithstanding the foregoing, neither Party shall
be obligated to Develop, seek Regulatory Approval or Commercialize a Licensed
Compound or Product: (i) which, in its reasonable opinion after discussion with
the other Party, caused or is likely to  cause a fatal, life-threatening or
other serious adverse safety event that is reasonably expected, based upon then
available data, to preclude obtaining Regulatory Approval for such Product or
Licensed Compound, or, if Regulatory Approval of such Product has already been
obtained, to preclude continued marketing of such Product; or (ii) in a manner
inconsistent with Applicable Laws.

 

1.31        “Committee” shall have the meaning set forth in Section 2.5.

 

1.32        “Common Stock” shall have the meaning set forth in Section 16.1(a).

 

1.33        “Confidential Information” shall have the meaning set forth in
Section 10.1.

 

1.34        “Control,” “Controls”, or “Controlled by” shall mean, with respect
to any Information, Patent or other intellectual property right, possession by a
Party, including its Affiliates, of the ability (whether by ownership, license
or otherwise, but without taking into account any rights granted by one Party to
the other Party under the terms of this Agreement) to grant access, a license or
a sublicense to such Information or intellectual property right without
violating the terms of any agreement or other arrangement with any Third Party
as of the time such Party would be first required under this Agreement to grant
the other Party such access, license or sublicense.

 

1.35        “Cost of Goods” shall mean the cost to manufacture a given Licensed
Compound or Product in bulk form or final therapeutic form, which shall mean:
(i) in the case of products and services acquired from Third Parties, payments
made to such Third Parties; and (ii) in the case of manufacturing services
performed by a Party or its Affiliates, including manufacturing services to
support products and services acquired from Third Parties as contemplated in
subsection (i) above,  the actual unit costs of manufacture in bulk form or
final therapeutic form, as the case may be, plus the variances and other costs
specifically provided for herein.  Actual unit costs shall consist of direct
material costs, direct labor costs and manufacturing overhead directly
attributable to the Licensed Compound or Product, all calculated in accordance
with GAAP.  Direct material costs shall include the costs incurred in purchasing
materials, including sales and excise taxes imposed thereon, customs duties and
charges levied by government authorities, and all costs of packaging components.
Direct labor costs shall include the cost of: (a) employees working in Licensed
Compound or Product manufacturing and packaging and

 

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engaged in direct manufacturing activities; (b) the acquisition of Third Party
manufacturing products and services; and (c) direct or indirect quality control
and quality assurance activities.  Manufacturing overhead attributable to a
Licensed Compound or Product shall include a reasonable allocation of indirect
labor costs (not previously included in direct labor costs), a reasonable
allocation of administrative costs and a reasonable allocation of facilities and
other overhead costs.

 

1.36        “Curis Agreement” shall mean that certain License Agreement between
Curis Inc. (“Curis”) and Amylin, dated December 4, 2002, as amended.

 

1.37        “CV Safety Study” shall have the meaning set forth in
Section 3.11.1.

 

1.38        “Database Lock Date” shall have the meaning set forth in
Section 3.11.1.

 

1.39        “Detail” or “Detailing” shall mean, except as otherwise provided in
this Section 1.39, a face-to-face meeting, between a Medical Sales
Representative of the applicable Party, and a health care professional with
prescribing authority, during which a presentation of the Product’s attributes
is orally presented in a manner consistent with industry standards and with the
quality of similar presentations made by a Party’s Medical Sales Representatives
for such Party’s other products, if applicable.  A Detail does not include a
sample drop made by a Medical Sales Representative, and the Parties may agree in
the Commercialization Plan to include electronic Detailing by means of
information technology.

 

1.40        “Development” shall mean the conduct of all activities that are
reasonably required to obtain Regulatory Approval of a Product in the Field in
the Territory, or to obtain Regulatory Approval for an additional indication for
a Product that has previously obtained Regulatory Approval for an indication,
including: (i) toxicology, regulatory activities, pre-clinical studies and
Clinical Trials conducted in accordance with the cGLPs, cGCPs and cGMPs, or
other designated quality standards, and Applicable Laws; and (ii) all activities
relating to manufacturing Licensed Compounds or Products for pre-clinical and
feasibility studies and Clinical Trials, other than Post-Approval Clinical
Trials, including formulation, delivery technologies and devices, bulk
production, fill/finish, manufacturing process development, and manufacturing
and quality assurance technical support.

 

1.41        “Development Budget” shall mean the detailed budget for Development
activities that includes estimated headcount and other costs and resource
allocations by the Parties for all Development activities proposed for the
following [***], or for such longer period as the ODC may determine, and that is
included within each Development Plan, as such budget may be amended or updated
from time to time in accordance with Article 2.

 

1.42        “Development Costs” shall mean those costs and expenses incurred by
a Party or for its account after the Effective Date in the Development of
Products as reasonably required to obtain Regulatory Approval of Products in the
Field in the Territory consistent with the Development Plan.  Development Costs
include Third Party Development Costs and those costs and expenses incurred for:
(i) FTEs; (ii) CMC (chemistry, manufacturing and controls) activities including
those relating to Regulatory Approval Clinical Trials, but excluding
Post-Approval Clinical Trials; (iii) pre-clinical Development activities;
(iv) Clinical Trials including Regulatory

 

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Approval Clinical Trials, but excluding Post-Approval Clinical Trials and any
Phase 2 Clinical Trial for Davalintide that is on-going as of the Effective
Date; (v) Cost of Goods allocable to the manufacture of a Licensed Compound or
Product for Clinical Trials including Regulatory Approval Clinical Trials, but
excluding Post-Approval Clinical Trials, provided that any capital expenses
included in the Cost of Goods are directly allocable to the manufacture of
Licensed Compounds or Products used in Clinical Trials, and are approved in
accordance with Sections 2.2.5 and 2.1.4 and calculated in accordance with GAAP;
(vi) distribution costs; (vii) Product Liabilities; (viii) obtaining Regulatory
Approval, including NDA filing fees, but excluding costs relating to maintaining
Regulatory Approval; and (ix) other costs approved as part of the Development
Plan.  Development Costs shall be considered a cost or expense incurred by a
Party after the Effective Date, even though the actual payment for such cost or
expense is made prior to the Effective Date, if the corresponding work is
performed after the Effective Date, and shall be considered a cost or expense
that is not incurred by a Party after the Effective Date if the actual payment
for such cost or expense is made after the Effective Date, but the corresponding
work was performed prior to the Effective Date.  Notwithstanding anything to the
contrary contained in this Section 1.42, Development Costs shall not include any
internal personnel costs related to Commercialization, or any losses, damages,
fees, costs and other liabilities incurred by a Party as a result of such
Party’s negligence, gross negligence, willful misconduct or breach of such
Party’s representations and warranties made hereunder, and any such losses,
damages, fees, costs and other liabilities will be treated as the sole and
exclusive responsibility of the Party whose actions or omissions gave rise to
such losses, damages, fees, costs and other liabilities.

 

1.43        “Development Plan” shall mean a written [***] plan for the
Development of Products in the Field in the Territory, which plan includes a
Development Budget for all Development activities, as such plan may be amended
or updated from time to time in accordance with Article 2.  The Development
Plan, excluding certain Development activities (e,g., CMC and toxicology) and
the Development Budget, is attached hereto as Exhibit B, and [***].

 

1.44        “Development Program” shall mean the Development activities
undertaken by Amylin and Takeda pursuant to the Development Plan.

 

1.45        “Diabetes Indication” shall mean any indication included in
Section 1.51(ii).

 

1.46        “Dropped Product” shall have the meaning set forth in Section 8.2.1.

 

1.47        “Effective Date” shall mean October 30, 2009.

 

1.48        “EMEA” shall mean the European Medicines Agency and any successor
thereto.

 

1.49        “Excluded Products” shall mean: (i) any pharmaceutical product
containing or comprising Metreleptin (AC164594), or an Analog of Metreleptin, as
its sole active ingredient, including all formulations, line extensions and
modes of administration thereof, indicated for [***]

 

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; and (ii) any pharmaceutical product containing or comprising pramlintide,
currently marketed by Amylin as Symlin®, alone or in combination with other
compounds that are not Amylin Licensed Compounds, indicated for glycemic control
(including Type 1 and Type 2 diabetes) in humans, including treatment,
management and prevention of glycemic control (including Type 1 and Type 2
diabetes).

 

1.50        “FDA” shall mean the U.S. Food and Drug Administration and any
successor thereto.

 

1.51        “Field” shall mean all human indications including, but not limited
to: (i) weight management (obesity, including weight loss and weight loss
maintenance) and/or treatment or prevention of obesity in humans; (ii) glycemic
control (including Type 1 and Type 2 diabetes) in humans, including treatment,
management and prevention of any disease or disorder relating to glycemic
control (including Type 1 and Type 2 diabetes); and (iii) the treatment,
management or prevention of any cardiovascular disease or disorder in humans;
provided, however, central nervous system indications, with respect to which
Amylin has no right to license or sublicense the Amylin Licensed Compounds or
Products to Takeda as of the Effective Date due to restrictions contained in the
Psylin Agreement, are excluded from this definition.

 

1.52        “Filing Party” shall have the meaning set forth in Section 12.3.2.

 

1.53        “First Commercial Sale” shall mean, with respect to any Product, on
a country-by-country basis, the first sale by a Party or a Party’s Affiliate or
sublicensee to a Third Party in a country after the Regulatory Authority in such
country has granted Regulatory Approval.  For clarification, the first sale by a
Party or a Party’s Affiliate or sublicensee to a Third Party for use or
consumption of a Product by a patient in a country after Regulatory Approval has
been granted, even if such Regulatory Approval contemplates further testing of
such Product (e.g., long-term safety testing), will constitute a First
Commercial Sale for purposes of this Agreement.

 

1.54        “First Position Detail” shall mean a Detail where the presentation
of a Product during the Detail is the first presentation made and more than
[***] percent ([***] %) of the time is spent during such Detail.

 

1.55        “FTE” shall mean the equivalent of a full-time employee’s work time
actually spent on the performance of Development activities over a twelve
(12)-month period (including normal vacations, sick days and holidays) based on
[***] ([***]) hours worked per twelve (12)-month period. Each employee utilized
by a Party in connection with its performance under a Development Plan may be
less than or greater than one FTE based on the hours actually worked by such
employee. For the avoidance of doubt, FTE only applies to employees of a Party,
and does not apply to contractors of a Party.

 

1.56        “GAAP” shall mean the generally accepted accounting principles of
the applicable country or jurisdiction, consistently applied, and shall mean the
international financial reporting standards (“IFRS”) at such time as IFRS
becomes the generally accepted accounting standard and Applicable Laws require
that a Party use IFRS.

 

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1.57        “Generic Product” shall mean, with respect to any Product, any
pharmaceutical product that is introduced in a country by a Person other than
Takeda or its Affiliates or sublicensees, which contains the same or equivalent
(by the FDA or other Regulatory Authority standards, on a country-by-country
basis) active pharmaceutical ingredient(s) as contained in such Product, and for
which Regulatory Approval is obtained by an abbreviated NDA or other abbreviated
process not requiring the filing of a complete NDA under laws or regulations of
the FDA or any other applicable Regulatory Authority, on a country-by-country
basis.

 

1.58        “Group” shall mean a group of related Persons deemed a “person” for
purposes of Section 13(d) of the U.S. Securities and Exchange Act of 1934, as
amended

 

1.59        “ICC Rules” shall have the meaning set forth in Section 15.3.

 

1.60        “IFRS” shall have the meaning set forth in Section 1.56.

 

1.61        “IND” shall mean an investigational new drug application, clinical
trial application, clinical trial exemption, or similar application or
submission for approval to conduct human clinical investigations filed with or
submitted to a Regulatory Authority in conformance with the requirements of such
Regulatory Authority, together with all additions, deletions, and supplements
thereto.

 

1.62        “Indemnifying Party” shall have the meaning set forth in
Section 14.3.1.

 

1.63        “Indemnitee” shall have the meaning set forth in Section 14.3.1.

 

1.64        “Information” shall mean information, ideas, inventions,
discoveries, concepts, compounds, compositions, formulations, formulas,
practices, procedures, processes, methods, knowledge, know-how, trade secrets,
technology, inventories, machines, techniques, development, designs, drawings,
computer programs, skill, experience, documents, apparatus, results, clinical
and regulatory strategies, regulatory documentation, information and submissions
pertaining to, or made in association with, filings with any Regulatory
Authority, data, including pharmacological, toxicological and clinical data,
analytical and quality control data, manufacturing data and descriptions, patent
and legal data, market data, financial data or descriptions, devices, assays,
chemical formulations, specifications, material, product samples and other
samples, physical, chemical and biological materials and compounds, and the
like, in written, electronic or other form, now known or hereafter developed,
whether or not patentable.

 

1.65        “Initial Royalty Term” shall mean, on a Product-by-Product and
country-by-country basis, the period of time commencing on the First Commercial
Sale of a Product in a country and ending upon the later of: (i) the earliest
date upon which both of the following have occurred: (a) the expiration of the
last to expire of all Amylin Patents and Joint Patents, and solely in the case
of any Product containing any Takeda Licensed Compound, Takeda Patents,
containing a Valid Claim regarding the composition of matter or method of
manufacture or use of such Product (or any Licensed Compound therein); provided,
however, such Valid Claim shall be considered for purposes of determining the
Initial Royalty Term for such Product in such country only if it provides, or
the Parties agree (and if the parties are unable to agree, then based upon the
opinion of a mutually agreeable independent patent counsel) that it is
reasonably likely to provide, sufficient market exclusivity to exclude Generic
Products in such country, and (b) the

 

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expiration of regulatory exclusivity for such Product in such country; or
(ii) the first commercial sale of a Generic Product in such country by any Third
Party other than a Takeda sublicensee. For the avoidance of doubt, the Parties
agree that: (a) if the First Commercial Sale of a Product in a country occurs
after the date in Section 1.65(ii) has taken place, there will be no Initial
Royalty Term for purposes of calculating royalties pursuant to Section 8.3, and,
instead, only the Secondary Royalty Term shall be applicable; and (b) for
purposes of Section 1.65(i) above, the Initial Royalty Term will end upon sale
of a Generic Product in any country of the Territory, provided that if sales of
such Generic Product are terminated thereafter, the Initial Royalty Term will
resume and the [***] percent ([***] %) royalty rate will be applied
retroactively for the period the Initial Royalty Term was suspended.

 

1.66        “In-License Agreement” means any of the Amgen Agreement, Curis
Agreement, Pacira Agreement or UM Agreement, each of which are listed on
Exhibit F.

 

1.67        “Invention” shall mean any and all inventions, discoveries and
developments, whether or not patentable, made, conceived or reduced to practice
in the course of performance of development or commercialization of Licensed
Compounds or Products, whether made, conceived or reduced to practice solely by
one or more employees or contractors of Amylin or its Affiliate, solely by one
or more employees or contractors of Takeda or its Affiliate, or jointly by one
or more employees or contractors of Amylin or its Affiliate and one or more
employees or contractors of Takeda or its Affiliate.

 

1.68        “Joint Inventions” shall have the meaning set forth in
Section 12.1.4.

 

1.69        “Joint Patents” shall have the meaning set forth in Section 12.1.4.

 

1.70        “JOPC” shall have the meaning set forth in Section 12.2.

 

1.71        “Knowledge” as used in Article 11 shall mean that Amylin or Takeda,
as the case may be, is deemed to be aware of a particular fact or other matter
to the extent a reasonably prudent manager (i.e. a person at the director level
or higher) of Amylin or Takeda, as the case may be, with experience in the
pharmaceutical industry would or should know of such fact or other matter after
reasonable inquiry thereof.

 

1.72        “Licensed Compound” shall mean any Amylin Licensed Compound or
Takeda Licensed Compound.

 

1.73        “Loan” shall have the meaning set forth in Section 3.11.1.

 

1.74        “Losses” shall have the meaning set forth in Section 14.1.

 

1.75        “Manufacturing Information” shall mean all Information Controlled by
Amylin as of the Effective Date or during the Term that is included in the
Amylin Technology and is necessary for the manufacture of any Amylin Licensed
Compound or Product, including but not limited to such Information contained in
the chemistry, manufacture and controls section of any applicable Regulatory
Materials and trade secrets.

 

1.76        “Material Activity” shall have the meaning set forth in
Section 12.4.2.

 

*** Confidential Treatment Requested

 

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1.77        “Materials” shall have the meaning set forth in Section 3.7.

 

1.78        “Medical Sales Representative” shall mean personnel hired by either
Takeda or Amylin or their Affiliates for the sales promotion of pharmaceutical
products who shall be responsible for Detailing the Products.  The term Medical
Sales Representatives does not include sales management and/or support staff,
and may include personnel employed by a contract sales organization if the
Parties mutually agree to use a contract sales organization to perform Details.

 

1.79        “NDA” shall mean a new drug application (as more fully defined in 21
C.F.R. 314.5 et seq.) filed with the FDA, or the equivalent application filed
with any Regulatory Authority outside the United States (including any
supra-national agency such as in the European Union), and all amendments and
supplements thereto, including all documents, data, and other information
concerning a pharmaceutical product, which are necessary for gaining Regulatory
Approval to market and sell such pharmaceutical product.

 

1.80        “Net Sales” shall mean the gross amounts invoiced by Takeda and its
Affiliates and sublicensees for sales or other dispositions of Products to Third
Parties that are not Affiliates or sublicensees, less the following items, as
allocable to such Products (if not previously deducted from the amount
invoiced): (i) trade, cash or quantity discounts, credits or allowances actually
allowed (provided that such discounts are applied in a normal and customary
manner with respect to other similarly situated products of the selling party,
and not in a manner which is unreasonably disproportionate to one or more
Products when compared to other products of the selling party); (ii) charge back
payments, administrative fees, price reductions and rebates allowed or granted
to managed care organizations, government agencies or trade customers, including
wholesalers and chain and pharmacy buying groups (provided that such discounts
are applied in a normal and customary manner with respect to other similarly
situated products of the selling party, and not in a manner which is
unreasonably disproportionate to one or more Products when compared to other
products of the selling party); (ii) credits actually allowed for claims,
allowances for damaged goods, retroactive price reductions or returned goods;
(iv) prepaid freight, postage, shipping, customs duties and insurance charges;
and (v) sales taxes, value added taxes, duties and other governmental charges
(including with respect to sales of Products in Japan, sales-based contributions
actually made by Takeda or its Affiliates or sublicensees for Contribution for
Drug Induced Suffering and Contribution for Measures for Drug Safety in the
amount determined by and payable to the Pharmaceuticals and Medical Devices
Agency (known as “Kiko”) in Japan, as consistently applied by Takeda to its
products), actually paid in connection with the sale, to the extent not
reimbursed (but excluding what are commonly known as income taxes).  Such
amounts shall be determined in accordance with GAAP, consistently applied, and
may include using accrual accounting where applicable.

 

In the case of any Product that contains any Licensed Compound(s) in combination
with any other clinically active ingredient(s) that is not a Licensed Compound,
whether packaged together or in the same therapeutic formulation (a “Combination
Product”) in any country, Net Sales for such Combination Product in such country
shall be calculated by multiplying actual Net Sales of such Combination Product
by the fraction A/(A+B) where A is the average invoice price of the Product
containing the Licensed Compound(s) as the only active ingredient(s), if sold
separately by Takeda, its Affiliates or sublicensees in such country, and B is
the average invoice price of the other active ingredient(s) in the Combination
Product, if sold separately by Takeda,

 

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its Affiliates or sublicensees in such country.  If, on a country-by-country
basis, the other active ingredient(s) in the Combination Product is not sold
separately by Takeda, its Affiliates or sublicensees in such country, Net Sales
for the purpose of determining royalties of the Combination Product shall be
calculated by multiplying actual Net Sales of such Combination Product by the
fraction A/D, where A is the average invoice price of the Product containing the
Licensed Compound(s) as the only active ingredient(s), if sold separately by
Takeda, its Affiliates or sublicensees in such country, and D is the average
invoice price of the Combination Product in such country.  If neither the
Product containing the Licensed Compound(s) as the only active ingredient(s) nor
the other active ingredient(s) in the Combination Product is sold separately in
a given country by Takeda, its Affiliates or sublicensees, the Parties shall
determine Net Sales for such Combination Product by mutual agreement based on
the relative contribution of the Product and the other active ingredient(s) in
the Combination Product.  For clarification, the provisions of this paragraph
shall not apply to any Combination Product that contains both an Amylin Licensed
Compound and a Takeda Licensed Compound as clinically active ingredients.

 

For purposes of the preceding paragraph, the invoice price of a Product
containing the Licensed Compound(s) as the only active ingredient(s) sold
separately for an indication designated as an “Orphan Product” under the U.S.
Orphan Drug Act, as amended, shall not be used to calculate Net Sales for any
Combination Product, except any such Combination Product that is used for an
indication designated as an “Orphan Product” under the U.S. Orphan Drug Act, as
amended.

 

1.81        “New Project” shall have the meaning set forth in Section 3.5.2.

 

1.82        “Obesity Indication” shall mean any indication included in
Section 1.51(i).

 

1.83        “OCC” shall mean the Obesity Commercialization Committee established
under Section 2.3.

 

1.84        “ODC” shall mean the Obesity Development Committee established under
Section 2.2.

 

1.85        “Option Compound” shall have the meaning set forth in Section 3.3.

 

1.86        “OSC” shall mean the Obesity Steering Committee established under
Section 2.1.

 

1.87        “Pacira Agreement” shall mean that certain Development and License
Agreement between Pacira Pharmaceuticals, Inc. (“Pacira”) and Amylin, dated as
of March 31, 2008, as amended.

 

1.88        “Partial Termination” shall have the meaning set forth in
Section 13.2.

 

1.89        “Patent Challenge” shall have the meaning set forth in
Section 13.2.2.

 

1.90        “Patents” shall mean: (i) all patents, certificates of invention,
applications for certificates of invention, priority patent filings and patent
applications, including patent applications under the Patent Cooperation Treaty
and the European Patent Convention; together with (ii) any renewal, division,
continuation (in whole or in part), or request for continued

 

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examination of any of such patents, certificates of invention and patent
applications, and any and all patents or certificates of invention issuing
thereon, and any and all reissues, reexaminations, extensions, divisions,
renewals, substitutions, confirmations, registrations, revalidations, revisions,
and additions of or to any of the foregoing, and any foreign counterparts of any
of the foregoing and any other patents and patent applications claiming priority
back to any of the foregoing.

 

1.91        “Payment Report” shall have the meaning set forth in Section 3.11.4.

 

1.92        “Person” shall mean a natural person, a corporation, a partnership,
a trust, a joint venture, a limited liability company, any Regulatory Authority
or any other entity or organization.

 

1.93        “Phase 1 Clinical Trial” shall mean a clinical trial of a Product
conducted in a small number of human volunteers in any country designed or
intended to establish an initial safety profile, pharmacodynamics, or
pharmacokinetics of a Product.

 

1.94        “Phase 2 Clinical Trial” shall mean a clinical trial of a Product
conducted in human patients in any country to determine initial efficacy and
dose range finding before embarking on a Phase 3 Clinical Trial.

 

1.95        “Phase 3 Clinical Trial” shall mean a pivotal clinical trial of a
Product conducted in human patients in any country with a defined dose or a set
of defined doses of a Product designed to ascertain efficacy and safety of such
Product for the purpose of submitting applications for Regulatory Approval to
the competent Regulatory Authorities.

 

1.96        “Phase 4 Clinical Trial” shall mean a clinical trial of a Product
conducted in human patients in any country after Regulatory Approval of such
Product in such country.

 

1.97        “Post-Approval Clinical Trials” shall mean Phase 3 Clinical Trials
or Phase 4 Clinical Trials in any country of the Territory, the results of which
are intended, as of the date each such clinical trial commences, to be used to
support an expanded label claim for a Product (and not to obtain Regulatory
Approval for an additional indication) in the Territory (even if such expanded
label claims are marketed in the Territory under a different marketing
authorization or trademark), or otherwise support marketing of a Product in the
Territory, regardless of whether such clinical trial is commenced prior to
filing of the Regulatory Approval for such Product in the Territory. For the
avoidance of doubt, a Post-Approval Clinical Trial shall not include a Phase 3
Clinical Trial or Phase 4 Clinical Trial, the results of which are required by a
Regulatory Authority or otherwise intended to be used to support the continued
Regulatory Approval of a Product in a given indication in the Field in a country
in the Territory, even if such Phase 3 Clinical Trial or Phase 4 Clinical Trial
is commenced after Regulatory Approval of such Product in such indication in
such country.

 

1.98        “Primary Detail Equivalent” or “PDE” shall mean a numerical amount
that scores the value of Details performed by Medical Sales Representatives as
follows: [***] for each First Position Detail, and [***] for each Second
Position Detail.

 

*** Confidential Treatment Requested

 

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1.99        “Product” shall mean any formulated, or formulated and packaged (as
the context requires), pharmaceutical product containing or comprising: (i) any
Licensed Compound as the sole active ingredient; or (ii) any Licensed Compound
in combination with one or more other Licensed Compound(s), or clinically active
ingredient(s) other than Licensed Compound(s); provided, however, Product shall
not include any Excluded Product.  In addition, each separate formulation of a
Licensed Compound that: (a) utilizes an Alternative Delivery System; or (b) is
administered on a meaningfully different frequency (e.g., BID Product, QD
Product and QW Product) shall be considered a separate Product.  As an example,
(1) a Product containing Davalintide as the sole active ingredient and a Product
containing Davalintide in combination with another clinically active ingredient,
such as OPT, would be considered two (2) separate Products; and (2) a Product
containing Davalintide in a BID injectable presentation, and a Product
containing Davalintide administered via an Alternate Delivery System (e.g.,
sublingual or transdermal), would also be considered two (2) separate Products.
Additionally, for clarification purposes, Davalintide in two (2) different
dosage strengths, but not in different frequencies of administration or
administered via an Alternate Delivery System, would not be considered separate
Products.

 

1.100      “Product Liabilities” shall mean all losses, damages, fees, costs and
other liabilities incurred by a Party or its Affiliates and resulting from human
use of  a Licensed Compound or Product in Clinical Trials (including Regulatory
Approval Clinical Trials, but excluding Post-Approval Clinical Studies), but
excluding all losses, damages, fees, costs and other liabilities that are a
result of a Party’s or its Affiliates’ negligence, gross negligence, willful
misconduct or breach of such Party’s representations and warranties made
hereunder.  For the avoidance of doubt, Product Liabilities include reasonable
attorneys’ and experts’ fees and costs relating to any claim or potential claim
by any Third Party against a Party or its Affiliates, and all losses, damages,
fees, costs and other liabilities associated with the voluntary or involuntary
withdrawal of a Product, or seizure of a Product by a Regulatory Authority.

 

1.101      “Proposing Party” shall have the meaning set forth in Section 3.5.2.

 

1.102      “Psylin Agreement” shall mean that certain Technology License and
Option Agreement between Psylin Neurosciences, Inc. (“Psylin”) and Amylin, dated
as of January 25, 2007, as amended.

 

1.103      “QD Product” shall mean any Product formulated for once daily (QD)
injectable administration.

 

1.104      “Quarterly Report” shall have the meaning set forth in
Section 3.11.4.

 

1.105      “QW Product” shall mean any Product formulated for once weekly (QW)
or less frequent injectable administration.

 

1.106      “Regulatory Approval” shall mean any approval or authorization of any
Regulatory Authority in a particular jurisdiction that is necessary for the
manufacture, use, storage, import, transport and/or sale of a Product in such
jurisdiction in accordance with Applicable Laws.

 

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1.107      “Regulatory Approval Clinical Trials” shall mean Phase 3 Clinical
Trials or Phase 4 Clinical Trials of a specific Product in any country of the
Territory, which are: (i) not Post-Approval Clinical Trials; (ii) designed to
generate specific safety data; and (iii) required by a Regulatory Authority,
(a) as a condition to granting Regulatory Approval for such Product, or (b) to
support the continued Regulatory Approval of such Product, even if such Phase 3
Clinical Trials or Phase 4 Clinical Trials are commenced prior to Regulatory
Approval of a specific Product in any country of the Territory.

 

1.108      “Regulatory Authority” shall mean any national or supranational
governmental authority, including the FDA and the EMEA, that has responsibility
in any country or other regulatory jurisdiction over the Development and/or
Commercialization of a Product in the Field in the Territory.

 

1.109      “Regulatory Materials” shall mean any regulatory submissions,
notifications, registrations, approvals and/or other filings, including Clinical
Trial master files and drug master files Controlled by a Party, made to or with
a Regulatory Authority that may be necessary or reasonably desirable to Develop,
manufacture, market, sell or otherwise Commercialize a Product in the Field in
the Territory.

 

1.110      “Secondary Royalty Term” shall mean, on a Product-by-Product and
country-by-country basis, the period of time commencing immediately upon the
expiration of the Initial Royalty Term for a Product in a country and ending
upon the earlier of: (i) the last day of the first calendar quarter in which the
total units of a Generic Product sold in such country by one or more parties
other than Takeda or its Affiliate or sublicensee equal or exceed the total
units of the applicable Product sold in such country by Takeda or its Affiliate
or sublicensee during such calendar quarter; or (ii) [***] ([***]) years after
expiration of the Initial Royalty Term.

 

1.111      “Second Position Detail” shall mean a Detail where the presentation
of a Product during the Detail is the presentation on which the second most
amount of time is spent during such Detail.

 

1.112      “Shionogi Agreement” shall mean the license agreement between Amylin
and Shionogi & Co., Ltd. dated July 8, 2009, as amended.

 

1.113      “Standstill Period” shall have the meaning set forth in Section 16.1.

 

1.114      “Takeda Compound Related Inventions” shall have the meaning set forth
in Section 12.1.1.

 

1.115      “Takeda Indemnitee” shall have the meaning set forth in Section 14.2.

 

1.116      “Takeda Know-How” shall mean Information not included in the Takeda
Patents that Takeda or its Affiliates Control on the Effective Date or during
the Term, which Information is necessary to develop, make, have made,
distribute, use, offer for sale, sell, import, export and otherwise
Commercialize the Takeda Licensed Compounds and Products in the Field, including
any replication or any part of such Information and including information and
know-how that Takeda or any of its Affiliates Controls on the Effective Date or
during the Term which is necessary or useful to conduct research on the Licensed
Compounds and Products in the Field in

 

*** Confidential Treatment Requested

 

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the Territory in support of Development and Commercialization activities as
contemplated by this Agreement (but excluding assays, computer programs,
materials or other research tools).

 

1.117      “Takeda Licensed Compound” shall mean any Takeda Nominated Compound
that is nominated by Takeda, and that Amylin agrees to add to this Agreement,
pursuant to Section 3.4.

 

1.118      “Takeda Nominated Compound” shall have the meaning set forth in
Section 3.4.

 

1.119      “Takeda Patents” shall mean all Patents that Takeda Controls as of
the Effective Date or during the Term, which Patents are necessary to research,
develop, make, have made, distribute, use, offer for sale, sell, import, export
and otherwise Commercialize the Takeda Licensed Compound and Products in the
Field, but excluding Joint Patents.

 

1.120      “Takeda Technology” shall mean the Takeda Know-How and Takeda
Patents.

 

1.121      Takeda Y-family Agonists” shall mean: (i) the Analogs of Y-family
agonists Controlled by Takeda as of the Effective Date and listed on Exhibit E;
and (ii) the Analogs of any of the compounds identified in Section 1.121(i) that
may come under the Control of Takeda or its Affiliates during the Term.

 

1.122      “Term” shall have the meaning set forth in Section 13.1.

 

1.123      “Terminated Country” shall have the meaning set forth in
Section 13.3.1.

 

1.124      “Terminated Product” shall have the meaning set forth in
Section 13.3.1.

 

1.125      “Territory” shall mean all the countries of the world.

 

1.126      “Third Party” shall mean a Person other than Takeda and its
Affiliates and Amylin and its Affiliates.

 

1.127      “Third Party Agreement” shall have the meaning set forth in
Section 16.1.

 

1.128      “Third Party Development Costs” shall mean costs and expenses for the
Development of Licensed Compounds or Products paid or payable by a Party, or for
its account, to a Third Party relating to: (i) professional services;
(ii) contract research services; (iii) research grants; (iv) clinical grants;
(v) consultants; (vi) clinical investigation start-up meetings; (vii) Clinical
Trials, including Regulatory Approval Clinical Trials, but excluding
Post-Approval Clinical Trials and any Phase 2 Clinical Trial for Davalintide
that is on-going as of the Effective Date; (viii) contract labor; (ix) obtaining
Regulatory Approval, but excluding costs relating to maintaining Regulatory
Approval; and (x) other activities approved by the Parties in the Development
Plan.

 

1.129      “Third Party Standstill Provisions” shall have the meaning set forth
in Section 16.1.

 

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1.130      “Tier 1 Product” shall have the meaning set forth in Section 8.3.1.

 

1.131      “Tier 2 Product” shall have the meaning set forth in Section 8.3.2.

 

1.132      “Tier 3 Product” shall have the meaning set forth in Section 8.3.3.

 

1.133      “UM Agreement” means that certain Confidential Agreement and Release
of All Claims among the University of Minnesota and Per Westermark
(collectively, “UM”) and Amylin, dated October 21, 1998, as amended.

 

1.134      “United States” or “U.S.” shall mean the United States of America,
its territories and possessions including Puerto Rico and the District of
Columbia.

 

1.135      “U.S. Development Costs” shall mean those Development Costs incurred
by a Party, or for its account, in connection with Development activities
necessary for or intended to support obtaining Regulatory Approval of Products
in the Field in the United States, which Development activities are consistent
with the Development Plan and calculated in accordance with Section 3.11, even
if such Development activities also support obtaining Regulatory Approvals in
countries in the Territory other than the United States.  For the avoidance of
doubt, Development Costs relating to Development activities that take place
outside the United States, but are necessary for or intended to support
obtaining Regulatory Approval of Products in the Field in the United States,
shall be considered U.S. Development Costs.

 

1.136      “Valid Claim” shall mean a claim of an issued patent within the
Amylin Patents, Takeda Patents, or Joint Patents which has not expired, been
disclaimed, been cancelled or superseded (or if cancelled or superseded, has
been reinstated) or been revoked, held invalid, or otherwise declared
unenforceable or not allowable by a tribunal or patent authority of competent
jurisdiction over such claim in such country from which no further appeal has or
may be taken.

 

1.137      “Withdrawal Notice” shall have the meaning set forth in Section 2.5.

 

2.             GOVERNANCE

 

2.1          Obesity Steering Committee.  The Parties will establish the OSC to
oversee the activities of the Parties pursuant to this Agreement.

 

2.1.1       Composition.  The OSC will be comprised of an equal number of
members appointed by each of Takeda and Amylin, each of whom shall be senior
enough within the applicable Party’s organization to have decision-making
authority with respect to Development or Commercialization of the Licensed
Compounds and Products as if such Licensed Compounds and Products were
proprietary to such Party.  Each Party shall designate [***] ([***]) OSC
representatives promptly after the Effective Date.  The Parties, through the
OSC, may later change the number of OSC members as long as an equal number of
members from each of Takeda and Amylin is maintained.  Each Party may change its
OSC members at any time by written notice to the other Party, which may be
delivered at a scheduled meeting of the OSC.  Each Party shall designate one of
its representatives on the OSC as a co-chair of the OSC. The chairmanship of the
OSC shall alternate between the Parties for each consecutive [***] period
following the Effective Date, and the first chairman of the OSC shall be a

 

*** Confidential Treatment Requested

 

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representative of Takeda.  The role of the chairman shall be to convene and
preside at meetings of the OSC, but the chairman shall not be entitled to
prevent items from being discussed or to cast any tie breaking vote.

 

2.1.2       Responsibilities.  The OSC shall be responsible for setting the
overall strategic direction relating to the global Development and
Commercialization of Licensed Compounds and Products in the Field in the
Territory.  The specific responsibilities of the OSC shall be:

 

(a)           Reviewing and approving the Development Plan and Development
Budget for the United States, and any amendments thereto, submitted by the ODC;
provided, further, the OSC shall approve the designation of, or designate, as
applicable, those Development Costs which are U.S. Development Costs;

 

(b)           Reviewing, but not approving, the Development Plan and Development
Budget for countries in the Territory other than the United States;

 

(c)           If Amylin exercises the Co-Commercialization Option, reviewing and
approving the Commercialization Plan for the United States and any amendments
thereto submitted by the OCC;

 

(d)           If Amylin does not exercise, or has not yet exercised, the
Co-Commercialization Option, reviewing, but not approving, the Commercialization
Plan for the United States and any amendments thereto submitted by the OCC.

 

(e)           Reviewing, but not approving, the Commercialization Plan for
countries in the Territory other than the United States, and any amendments
thereto submitted by the OCC.

 

(f)            Establishing such joint teams and subcommittees as it deems
necessary to fulfill this Agreement;

 

(g)           Resolving any disputes among such joint teams or subcommittees,
including the ODC, subject to the terms of this Agreement;

 

(h)           Developing and implementing  reporting mechanisms for the ODC and
OCC; and

 

(i)            Approving and/or deciding such other matters as may be provided
elsewhere in this Agreement.

 

The OSC shall periodically, but no less than [***], review the results of the
Development Plan and Commercialization Plan with respect to Products in the
Field in the Territory to ensure, to the extent reasonably practical, that the
Parties are meeting their commitments for both human and financial support and
are each fulfilling all of their respective contractual obligations.  The OSC
shall resolve any disputes referred to it in accordance with Section 2.1.4
below.

 

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2.1.3       Meetings.  The OSC will hold an in-person organizational meeting at
Amylin’s offices in San Diego, California to establish the OSC’s operating
procedures.  After such initial meeting, the OSC will meet at such other times
as are agreeable to a majority of the OSC members, but no less than once each
calendar quarter.  Such meetings may be in-person, via videoconference, or via
teleconference.  Meetings may only be held if at least [***] ([***]) OSC members
from each Party are present and participating. After the initial meeting above,
the location of in-person OSC meetings will alternate between San Diego,
California and Chicago, Illinois, unless the Parties otherwise agree.  Each
Party will bear the expense of its respective OSC members’ participation in OSC
meetings. With the prior consent of the other Party’s members, (such consent not
to be unreasonably withheld or delayed), each Party may invite non-members to
participate in the discussions and meetings provided that such participants
shall have no voting rights or powers and shall be subject to the
confidentiality provisions in Article 10. Additional meetings of the OSC may
also be held to resolve any dispute referred to the OSC. Meetings to resolve
disputes shall be held within [***] following referral to the OSC or as soon as
reasonably practical.  All agenda items proposed by a Party for discussion or
decision at a meeting must be provided to the Alliance Manager responsible for
the agenda for the next meeting, together with appropriate information related
thereto, at least [***] in advance of the meeting.  Material decisions reached
at a meeting will be documented by both Parties before the meeting ends. 
Reasonably detailed written minutes will be kept of all OSC meetings and will
reflect material decisions made at such meetings.  The Alliance Manager of the
same Party as the acting chairman of the OSC shall be responsible for
(i) preparing and circulating an agenda for each upcoming OSC meeting, and
(ii) preparing and issuing the meeting minutes to each member of the OSC for
review and approval within [***] after such meeting.  Minutes will be deemed
approved unless a member of the OSC objects to the accuracy of such minutes
within [***] of receipt.

 

2.1.4       Decisions.  All OSC decisions will be made by unanimous vote, with
the representatives of Amylin on the OSC collectively having one vote and the
representatives of Takeda on the OSC collectively having one vote; provided,
however, that in no event shall the OSC have the right or power to resolve any
such matter in a manner that conflicts with the provisions of this Agreement or
to unilaterally amend or modify this Agreement.  [***].  If the OSC is unable to
decide or resolve unanimously any other matter within [***] following the
presentation of such matter to the OSC (or such longer period as agreed by the
OSC), including any matter that may result in U.S. Development Costs, the matter
shall be submitted for resolution in accordance with the dispute resolution
provisions set forth in Article 15; provided, however, notwithstanding the
foregoing, failure of the OSC to unanimously approve the following activities
will not be subject to the provisions of Sections 15.2 and 15.3: [***]. For
clarification, the determination by

 

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either Party that a safety issue exists permitting termination of this Agreement
under Section 13.2.3(a) shall not be subject to the dispute resolution
provisions contained in Sections 15.2 and 15.3; provided, however, if a Party
believes in good faith that the election by the other Party to terminate this
Agreement under Section 13.2.3(a) was a breach of this Agreement because the
electing Party had not in fact determined that a safety issue permitting such
termination existed, then such dispute shall be subject to the dispute
resolution provisions contained in Sections 15.2 and 15.3.

 

2.2          Obesity Development Committee.  The Parties will establish the ODC
to create and implement the Development Plan and oversee the Development
activities performed pursuant to this Agreement.

 

2.2.1       Composition.  The ODC will be comprised of an equal number of
members appointed by each of Takeda and Amylin.  Each Party shall designate
[***] ([***]) ODC representatives within [***] after the Effective Date. The ODC
may later change the number of ODC members as long as an equal number of members
from each of Takeda and Amylin is maintained.  Each Party may change its ODC
members at any time by written notice to the other Party, which may be delivered
at a scheduled meeting of the ODC.  Each ODC representative shall have
appropriate expertise regarding the clinical development of pharmaceutical
products, and each Party shall designate one of its representatives on the ODC
as a co-chair of the ODC. The chairmanship of the ODC shall alternate between
the Parties for each consecutive [***]  following the Effective Date, and the
first chairman of the ODC shall be a representative of Amylin.  The role of the
chairman shall be to convene and preside at meetings of the ODC, but the
chairman shall not be entitled to prevent items from being discussed or to cast
any tie breaking vote.

 

2.2.2       Responsibilities.  The ODC will be responsible for the creation and
implementation of the Development Plan and corresponding Development Budget,
including designating in the Development Budget those Development Costs which
constitute U.S. Development Costs, and for overseeing the Parties’ performance
of the activities pursuant to the Development Plan in accordance with
Section 3.1, and recommending such Development Plan and Development Budget to
the OSC for approval.  The ODC shall at all times coordinate the efforts of the
Parties with respect to the conduct of the Development Plan; provided that the
Party responsible for carrying out activities assigned to it under the
Development Plan will have decision-making rights with regard to day-to-day
conduct of such activities.  The ODC will also be responsible for determining
whether to recommend to the OSC for approval any amendments to the Development
Plan or Development Budget proposed by either Party.  The ODC will provide to
the Parties copies of any recommended Development Plan or Development Budget
before submission to the OSC.

 

2.2.3       Operation.  At least quarterly, a member of the ODC for each Party
shall provide to the other Party a reasonably detailed summary of the
Development activities conducted by such Party, including reconciliation of the
expenses against the Development Budget, and the co-chairs of the ODC shall
discuss the results of such activities, either in person or by telephone or
videoconference.  The co-chairs of the ODC will jointly prepare and provide to
the OSC, on at least a quarterly basis a report, via e-mail, regarding the
status of Development activities hereunder.  The ODC will review the progress of
the activities carried out pursuant to

 

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the Development Plan, including whether such activities are in compliance with
the Development Budget.

 

2.2.4       Meetings.  So long as the Parties continue to conduct Development
activities, the ODC will meet on a regular basis, but at least once per [***],
unless otherwise agreed by the Parties.  Such meetings may be in-person, via
videoconference, or via teleconference.  Meetings may be held only if at least
[***] ([***]) members from each Party are present and participating.  The
location of in-person ODC meetings will alternate between San Diego, California
and Chicago, Illinois, unless the Parties otherwise agree.  With the prior
consent of the other Party’s members (such consent not to be unreasonably
withheld or delayed), each Party may invite non-members to participate in the
discussions and meetings provided that such participants shall have no voting
rights or powers and shall be subject to the confidentiality provisions in
Article 10.  At least [***] prior to each ODC meeting, each Party shall provide
written notice to the Alliance Manager of the Party chairing the meeting of
agenda items proposed by such Party for discussion or decision at such meeting,
together with appropriate information related thereto.  Material decisions
reached at a meeting will be documented before the meeting ends.  Reasonably
detailed written minutes will be kept of all ODC meetings and will reflect
material decisions made at such meeting.  The Alliance Manager of the same Party
as the acting chairman of the ODC shall be responsible for: (i) preparing and
circulating an agenda for each upcoming OSC meeting; and (ii) preparing and
issuing the meeting minutes which will be sent to each member of the ODC for
review and approval within [***] after such meeting.  Minutes will be deemed
approved unless a member of the ODC objects to the accuracy of such minutes
within [***] of receipt.

 

2.2.5       Decisions.  All ODC decisions that may result in U.S. Development
Costs will be made by unanimous vote, with the representatives of Amylin on the
ODC collectively having one (1) vote and the representatives of Takeda on the
ODC collectively having one (1) vote. Takeda will have sole decision making
authority regarding Development activities for the Territory outside of the
United States, provided Takeda consider in good faith input from Amylin with
respect to such activities.  In the event of a dispute on any matter within the
responsibilities of the ODC regarding Development activities that may result in
U.S. Development Costs, such matter shall be referred to the OSC for resolution
in accordance with the procedures set forth in Section 2.1.4.  In no event shall
the ODC have the right or power to resolve any such matter in a manner that
conflicts with the provisions of this Agreement or to unilaterally amend or
modify this Agreement.

 

2.2.6       Subcommittees.  The ODC may establish such subcommittees as it may
deem desirable.  All such subcommittees shall have equal representation from
each Party unless the Parties expressly agree otherwise.  A subcommittee
chairman shall be appointed by each Party, which subcommittee chairman shall
report to the ODC as needed or required by the ODC.

 

2.3          Obesity Commercialization Committee.  The Parties will establish
the OCC to review the conduct and progress of Commercialization of Products in
the Field in the Territory.

 

 

2.3.1       Composition.  The OCC will be comprised of an equal number of
members appointed by each of Takeda and Amylin. Each Party shall designate [***]
([***]) OCC representatives within [***] after the Effective Date.  The Parties,
through the OCC,

 

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may later change the number of OCC members as long as an equal number of members
from each of Takeda and Amylin is maintained.  Each Party may change its OCC
members at any time by written notice to the other Party, which may be delivered
at a scheduled meeting of the OCC.  Takeda shall designate one of its
representatives on the OCC as the chairman of the OCC. The chairman will be
responsible to convene and preside at meetings of the OCC, and the Takeda
Alliance Manager shall be responsible for preparing and issuing the minutes of
each such meeting and preparing and circulating an agenda for each upcoming
meeting, but neither the Alliance Manager nor the chairman shall have any
special authority over the other members of the OCC and shall not be entitled to
prevent items from being discussed.

 

2.3.2       Responsibilities.  The OCC will provide a forum for the Parties to
review the conduct and progress of the Commercialization of the Products in the
Field in the Territory and for Amylin to provide input to Takeda regarding the
Commercialization Plan prepared by Takeda and such Commercialization activities.
Takeda will take Amylin’s input into consideration in good faith.  In addition,
an OCC representative(s) shall be responsible for providing input at ODC
meetings, as necessary.

 

2.3.3       Meetings.  The OCC will meet on a regular basis as determined by the
Parties, but at least once per [***]. Such meetings may be in-person, via
videoconference, or via teleconference.  The location of in-person OCC meetings
will alternate between San Diego, California and Chicago, Illinois, unless the
Parties otherwise agree.  Each Party will bear the expense of its respective OCC
members’ participation in OCC meetings.  At least [***]  prior to each OCC
meeting, each Party shall provide written notice to Takeda’s Alliance Manager of
agenda items proposed by such Party for discussion or decision at such meeting,
together with appropriate information related thereto.  Material decisions
reached at a meeting will be documented before the meeting ends.  Reasonably
detailed written minutes will be kept of all OCC meetings and will reflect
material decisions made at such meeting.  Meeting minutes will be sent to each
member of the OCC for review and approval within [***] after a meeting.  Minutes
will be deemed approved unless a member of the OCC objects to the accuracy of
such minutes within [***] of receipt.

 

2.3.4       Decisions.  All OCC decisions will be made by Takeda after
considering in good faith input from Amylin, including OCC decisions made after
Amylin exercises the Co-Commercialization Option with respect to a Product.  In
no event shall the OCC have the right or power to resolve any matter in a manner
that conflicts with the provisions of this Agreement, or to unilaterally amend
or modify this Agreement. For purposes of clarification only, and without
limiting the foregoing, the OCC shall not have the right or power to make any
decision that would result in U.S. Development Costs, unless such U.S.
Development Costs are approved by the ODC in accordance with Section 2.2.5, and
the OSC in accordance with Section 2.1.4.

 

2.3.5       Subcommittees.  The OCC may establish such committees as it deems
desirable.  All such subcommittees shall have equal representation from each
Party, unless the Parties specifically agree otherwise.

 

2.4          Alliance Managers.  Within [***] after the Effective Date, Amylin
and Takeda each shall appoint a person from within their respective
organizations (an “Alliance

 

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Manager”) to coordinate and facilitate the interaction and cooperation of the
Parties pursuant to this Agreement.  The Alliance Managers shall be the primary
contact between the Parties with respect to the activities conducted pursuant to
this Agreement.  Each Party shall notify the other Party promptly of any change
in the identity of the Alliance Manager.

 

2.5          Withdrawal.  At any time during the Term and for any reason, Amylin
shall have the right to withdraw from participation in the OSC, ODC and/or OCC
(each, a “Committee”) upon written notice to Takeda, which notice shall be
effective immediately upon receipt (the “Withdrawal Notice”). Following the
issuance of a Withdrawal Notice and subject to this Section 2.5, Amylin’s
representatives to the applicable Committee shall not participate in any
meetings of the applicable Committee, nor shall Amylin have any right to vote on
decisions within the authority of the applicable Committee.  If, at any time,
following the issuance of a Withdrawal Notice, Amylin wishes to resume
participation in the applicable Committee, Amylin shall notify Takeda in writing
and, thereafter, Amylin’s representatives to the applicable Committee shall be
entitled to attend any subsequent meeting of such Committee and to participate
in the activities of, and decision-making by, such Committees as provided in
this Article 2 as if a Withdrawal Notice had not been issued by Amylin;
provided, further, if Amylin returns to a particular Committee and again
withdraws from such Committee in accordance with this Section 2.5, it may return
to such Committee only upon receipt of prior written consent from Takeda. 
Following Amylin’s issuance of a Withdrawal Notice, unless and until Amylin
resumes participation in the applicable Committee in accordance with this
Section 2.5: (i) all meetings of the applicable Committee shall be held at
Takeda’s facilities; (ii) Takeda shall have the right to make the final decision
on all matters within the scope of authority of such Committee; and (iii) Amylin
shall have the right to continue to receive the minutes of such Committee
meetings, but shall not have the right to approve the minutes for any such
Committee meeting held after Amylin’s issuance of a Withdrawal Notice.

 

3.             DEVELOPMENT

 

3.1          Development Plan.  The Development of Products in the Field in the
Territory shall be governed by a comprehensive Development Plan, including a
Development Budget.  The ODC shall coordinate with the OCC to ensure that the
Development Plan appropriately supports Commercialization efforts with regard to
Products in the Field in the Territory.  The Parties through the ODC shall
update and amend the [***] Development Plan within [***]  after the Effective
Date, which such updated Development Plan shall include: (i) all clinical and
non-clinical Development activities (e.g., CMC and toxicology); and (ii) the
Development Budget.  Thereafter, for each calendar year during the Term, the
Parties through the ODC shall update and amend the [***] Development Budget no
later than [***] ([***]) of [***], which updates shall cover the ensuing [***]
and include a [***] plan for the [***] of the [***] period.  The [***]  of each
approved [***] Development Budget shall be a Binding Budget, unless otherwise
mutually agreed upon by the Parties in the Development Plan.  The [***] of such
approved [***] Development Budget will be a Binding Budget at [***] percent
([***] %) of the levels indicated, unless otherwise mutually agreed upon by the
Parties in the Development Plan.  The [***]  of such approved Development Budget
will be a good faith forecast and not a Binding Budget.  At least [***] ([***])
times per [***], the ODC will review the existing [***] Development Budget in

 

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order to update at least the first [***] of the forecast to reflect significant
changes to the operating assumptions based on, among other factors, the most
current data from Clinical Trials and Regulatory Authority guidance.  This [***]
forecast will serve as the basis for the construction of the Binding Budget in
the following year.  If the ODC cannot agree on a Binding Budget for the
succeeding calendar year (and the OSC cannot resolve any such disagreement), the
Parties agree to fund only [***] until such time as the Parties have resolved
any such disagreement pursuant to Article 15.

 

3.2          Development Activities. Each of Amylin and Takeda shall use
Commercially Reasonable Efforts to execute and perform its responsibilities, and
cooperate with the other Party in its efforts to execute and perform its
responsibilities, under the Development Plan including the Development Plan
attached hereto as Exhibit B.  Subject to the terms and conditions of this
Agreement, and except as otherwise agreed by the Parties in the Development
Plan: (i) Amylin shall be responsible for the execution of all Development
activities for each Product through the completion of all Phase 2 Clinical
Trials of such Product for the purpose of obtaining Regulatory Approval in the
United States; and (ii) Takeda shall be responsible for the execution of all
other Development activities for the purpose of obtaining Regulatory Approval in
the United States and in other countries of the Territory, in each case as set
forth in the Development Plan and Development Budget for each Product; provided,
further, for the avoidance of doubt, Takeda shall be responsible for the
execution of all Phase 3 Clinical Trials, Post-Approval Clinical Trials and
Regulatory Approval Clinical Trials of Products.  The ODC shall determine and
set forth in the Development Plan the respective responsibilities of each of the
Parties with respect to all Development activities other than the Development
activities otherwise described in this Section 3.2, and in Section 6.1 regarding
the manufacture and provision of clinical supplies for use in Development
activities.

 

3.3          Option Compounds.  Amylin shall have: (i) other than for Analogs of
Amylin Licensed Compounds subject to the terms and conditions of
Section 3.3(ii), the right, but not the obligation, to nominate any analog of
any of the Amylin Licensed Compounds listed in Section 1.8(i)—(iv), provided
such analog is not already an Amylin Licensed Compound and/or listed on
Exhibit C, to be added as an Amylin Licensed Compound under this Agreement; and
(ii) the obligation to nominate as an additional Amylin Licensed Compound under
this Agreement, within a timeframe commencing [***] prior to and ending [***]
after the commencement of IND-enabling activities (e.g., GLP toxicity studies)
by Amylin, any Analog of any of the Amylin Licensed Compounds listed in
Section 1.8(i)—(iv), which Analog demonstrates as a monotherapy, or as a
combination therapy with a Licensed Compound or another Analog of any Licensed
Compound (provided such combination therapy demonstrates a greater weight loss
effect than either the Licensed Compound or Analog thereof as a monotherapy),
weight loss that is equal to or exceeds [***] percent ([***] %) in a composite
of pre-clinical studies and/or animal models, or any clinical trial.  If Amylin
nominates any analog or Analog to be added as an Amylin Licensed Compound
pursuant to Section 3.3(i) or (ii) above, it will provide a written notice to
Takeda identifying such analog or Analog, and provide such other information,
including applicable pre-clinical study results and clinical trial results, as
may be reasonably necessary for Takeda to determine whether to add such analog
or Analog as an Amylin Licensed Compound.  Takeda shall have [***] from the date
of receipt of such written notice to inform Amylin it desires to add such analog
or Analog as an Amylin

 

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Licensed Compound.  If Takeda informs Amylin in writing within such [***]
([***]) day time period that it does desire to add such analog or Analog as an
Amylin Licensed Compound, then: (a) such analog or Analog shall immediately
become an “Option Compound” and be considered an Amylin Licensed Compound
hereunder; and (b) the ODC shall modify the Development Plan to provide for
Development of the Option Compound.  If Takeda informs Amylin in writing that it
does not desire to add such analog or Analog as an Amylin Licensed Compound, or
otherwise fails to respond to such written notice from Amylin within such [***]
([***]) day time period, then such analog or Analog shall not be an Option
Compound and shall not be added as an Amylin Licensed Compound, and Amylin shall
be free to develop such analog or Analog independently at its own expense;
provided, however, if Amylin subsequently develops in the Field any analog or
Analog that was subject to the procedures set forth in this Section 3.3 but was
not added as an Amylin Licensed Compound, such analog or Analog shall be subject
to the provisions of Section 3.5.2 regarding the right of Takeda to opt-in to
the Development of such analog or Analog (as if references to “Licensed Compound
or Product” in Section 3.5.2 referred instead to “analog or Analog of Amylin
Licensed Compound”).

 

3.4          Takeda Y-family Agonists and Takeda Nominated Compounds.  Takeda
shall have: (i) other than for any Takeda Y-family Agonist subject to the terms
and conditions of Section 3.4(ii), the right, but not the obligation, to
nominate any analog of a Takeda Y-family Agonist to be added as a Takeda
Licensed Compound under this Agreement; and (ii) the obligation to nominate as
an additional Takeda Licensed Compound under this Agreement, within a timeframe
commencing [***] prior to and ending [***] after commencement of IND-enabling
activities (e.g., GLP toxicity studies) by Takeda, a Takeda Y-family Agonist if
such Takeda Y-family Agonist demonstrates as a monotherapy, or as a combination
therapy with a Licensed Compound or an Analog of a Licensed Compound (provided
such combination therapy demonstrates a greater weight loss effect than either
the Licensed Compound or Analog thereof as a monotherapy), weight loss that is
equal to or exceeds [***] ([***] %) in a composite of pre-clinical studies
and/or animal models, or any clinical trial. If Takeda nominates any analog of a
Takeda Y-family Agonist under Section 3.4(i) or a Takeda Y-family Agonist under
Section 3.4(ii) (any of the foregoing, a “Takeda Nominated Compound”) to be
added as a Takeda Licensed Compound under this Agreement, it will provide a
written notice to Amylin, identifying such Takeda Nominated Compound, and
provide such other information, including applicable pre-clinical study results
and clinical trial results, as may be reasonably necessary for Amylin to
determine whether to add such Takeda Nominated Compound as a Takeda Licensed
Compound under this Agreement.  Amylin shall have [***] from the date of receipt
of such written notice to inform Takeda it desires to add such Takeda Nominated
Compound as a Takeda Licensed Compound under this Agreement.  If Amylin informs
Takeda in writing within such [***] time period that it does desire to add such
Takeda Nominated Compound as a Takeda Licensed Compound under this Agreement,
then: (a) such Takeda Nominated Compound shall immediately become a Takeda
Licensed Compound hereunder; (b) the ODC shall modify the Development Plan to
provide for Development of such Takeda Licensed Compound; and (c) the economic
terms applicable to a Product containing such Takeda Licensed Compound shall be
determined as set forth in Article 8.   If Amylin informs Takeda in writing that
it does not desire to add such Takeda Nominated Compound as a Takeda Licensed
Compound under this Agreement, or otherwise fails to respond to such written
notice from Takeda within such [***] time period, then such Takeda Nominated
Compound shall not be added as a Takeda Licensed Compound under this

 

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Agreement, and Takeda shall be free to develop such Takeda Nominated Compound
independently at its own expense; provided, however, if Takeda subsequently
develops in the Field any Takeda Nominated Compound that is a Takeda Y-family
Agonist and was subject to the procedures set forth in this Section 3.4 but was
not added as a Takeda Licensed Compound, such Takeda Y-family Agonist shall be
subject to the provisions of Section 3.5.2 regarding the right of Amylin to
opt-in to the Development of such Takeda Y-family Agonist (as if references to
“Licensed Compound or Product” in Section 3.5.2 referred instead to “Takeda
Y-family Agonist”).

 

3.5          Additional Development Activities

 

3.5.1       Collaborative Activities.  Before any Party engages in Development
activities that may result in U.S. Development Costs with respect to any
Licensed Compound or Product in the Field, and which activities are not included
in the then-current Development Plan, such Party shall submit a proposal to the
ODC for the Parties to engage jointly in such Development activities with
respect to such Licensed Compound or Product.  If the ODC elects to proceed, the
activities shall be incorporated into a draft Development Plan to be submitted
to the OSC for approval.

 

3.5.2       Independent Activities.       If either Party (the “Proposing
Party”) presents a proposal to the ODC to engage in Development activities that
may result in U.S. Development Costs with respect to any Licensed Compound or
Product in the Field, which such activities are not included in the then-current
Development Plan (each, a “New Project”), and the OSC ultimately fails to
approve the proposal due to the objection of the other Party, then the Proposing
Party may conduct the New Project independently at its expense, subject to the
following provisions:

 

(a)           If: (i) the New Project is a Phase 3 Clinical Trial for either an
Amylin Licensed Compound or Product that contains Davalintide (AC2307), or an
Amylin Licensed Compound or Product that contains both Pramlintide (AC137) and
Metreleptin (AC164594); (ii) the New Project is not selected for a Phase 3
Clinical Trial pursuant to the Development Plan; and (iii) the other Amylin
Licensed Compound or Product referenced in Section 3.5.2(a)(i) is selected for
Phase 3 Clinical Trials pursuant to the Development Plan, each Party agrees that
Takeda shall have the option, in its sole discretion, to delay the commencement
of such New Project (for clarification, the Phase 3 Clinical Trial for the
non-selected Amylin Licensed Compound or Product) for a period of up to [***]
following the date of the initiation of the first Phase 3 Clinical Trial for
such selected Amylin Licensed Compound or Product;

 

(b)           the Proposing Party shall conduct such activities solely at its
expense and substantially in accordance with the plans presented to the OSC, and
shall, at least annually, provide a report to the OSC of the results of such
efforts, and provide to the other Party such additional information as it may
reasonably request;

 

(c)           Within [***] after the date of database lock for the first Phase 2
Clinical Trial resulting from development activities regarding the New Project,
the Proposing Party shall furnish to the OSC and the other Party a written
report of the results of

 

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such trial, together with such other information available to the Proposing
Party as the other Party may reasonably request.  The other Party shall then
have a period of [***] in which to advise the Proposing Party whether it desires
to include the New Project within the Development Plan contemplated by this
Agreement.  If the other Party elects to include the New Project within the
Development Plan: (i) if such other Party is Takeda, it shall pay to the
Proposing Party an amount equal to [***] percent ([***] %) (which represents
[***] percent ([***] %) of Takeda’s share of U.S. Development Costs) of the
total Development Costs incurred to that date by the Proposing Party on the New
Project; (ii) if such other Party is Amylin, it shall pay to the Proposing Party
an amount equal to [***] percent ([***] %) (which represents [***] percent
([***] %) of Amylin’s share of U.S. Development Costs) of the total Development
Costs incurred to that date by the Proposing Party on the New Project; and
(iii) the New Project shall become part of the Development Plan contemplated by
this Agreement, with each Party having the same rights and obligations with
respect to the New Project as for any Licensed Compound or Product under this
Agreement; and

 

(d)           If the other Party has not elected to include the New Project in
the Development Plan pursuant to Section 3.5.2(c), then within [***] after the
date of the database lock for the first Phase 3 Clinical Trial resulting from
activities on the New Project, the Proposing Party shall furnish to the OSC and
the other Party a written report of the results of such trial, together with
such other information available to the Proposing Party as the other Party may
reasonably request.  The other Party shall then have a period of [***] ([***])
days in which to advise the Proposing Party whether it desires to include the
New Project within the Development Plan contemplated by this Agreement.  If the
other Party  elects to include the New Project within the Development Plan:
(i) if such other Party is Takeda, it shall pay to the Proposing Party an amount
equal to [***] percent ([***] %) (which represents [***] percent ([***] %) of
Takeda’s share of U.S. Development Costs) of the total Development Costs
incurred to that date by the Proposing Party on the New Project, plus any
milestones that would have otherwise been due under this Agreement; (ii) if such
other Party is Amylin, it shall pay to the Proposing Party an amount equal to
[***] percent ([***] %) (which represents [***] percent ([***] %) of Amylin’s
share of U.S. Development Costs) of the total Development Costs incurred to that
date by the Proposing Party on the New Project; (iii) the New Project shall
become part of the Development Plan contemplated by this Agreement, with each
Party having the same rights and obligations with respect to the New Project as
for any Product under this Agreement.  If the other Party does not select to
include the New Project in the Development Plan, the Proposing Party shall be
free to develop and commercialize such Licensed Compound or Product
independently or together with a Third Party without being subject to the terms
of this Agreement.

 

3.6          Exchange of Information.  Promptly following the Effective Date,
and promptly during the Term upon such Amylin Know-How being obtained or
generated by Amylin, Amylin shall provide to Takeda, at no additional cost or
expense to Takeda, all Amylin Know-How as is necessary to enable Takeda to
conduct Development and Commercialization activities assigned to it under the
Development Plan and Commercialization Plan or otherwise to practice the
licenses granted to it hereunder, to the extent such Amylin Know-How has not
previously been provided hereunder.  Promptly during the Term upon such Takeda
Know-How being obtained or generated by Takeda, Takeda shall provide to Amylin,
at no additional cost or expense to Amylin, all Takeda Know-How as is necessary
to enable Amylin to conduct Development

 

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activities assigned to it under the Development Plan and, if Amylin has
exercised its Co-Commercialization Option with respect to a Product, to
co-Commercialize such Product in the Field in the United States.

 

3.7          Materials Transfer.  In order to facilitate the Development
activities contemplated by this Agreement through the evaluation of compounds,
either Party may provide to the other Party certain biological materials or
chemical compounds Controlled by the supplying Party (collectively, “Materials”)
for use by the other Party in furtherance of such Development activities. 
Except as otherwise provided for under this Agreement, all such Materials
delivered to the other Party will remain the sole property of the supplying
Party, will be used only in furtherance of the Development activities conducted
in accordance with this Agreement, will not be used or delivered to or for the
benefit of any Third Party, except for subcontractors pursuant to Section 7.2.2,
without the prior written consent of the supplying Party, and will be used in
compliance with all Applicable Laws.  The Materials supplied under this
Agreement must be used with prudence and appropriate caution in any experimental
work because not all of their characteristics may be known. The supplying Party
will provide the other Party the most current material safety data sheet for the
Materials upon transfer of any Materials. Except as expressly set forth in this
Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT
THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER
PROPRIETARY RIGHTS OF ANY THIRD PARTY.

 

3.8          Records; Disclosure of Data and Results.  In conformity with
standard pharmaceutical industry practices and the terms and conditions of this
Agreement, each Party shall prepare and maintain, or shall cause to be prepared
and maintained, complete and accurate written records, accounts, notes, reports
and data with respect to activities conducted pursuant to the Development
Program for a minimum of [***] following the end of the calendar year to which
they pertain and, upon the other Party’s written request, shall send legible
copies of the aforesaid to the other Party throughout the Term and for a minimum
of [***] following the Term.  Upon reasonable advance notice, at the request of
the ODC, each Party agrees to make its employees and consultants reasonably
available at their respective places of employment to consult with the other
Party on issues arising in connection with the Development Program.  In
accordance with the reporting format and schedule approved by the ODC, each
Party shall promptly and fully disclose to the other Party in writing all data,
including preclinical data, Clinical Trial data, formulation data and
manufacturing data, generated by or on behalf of such Party with respect to
Products in the Field in the Territory.  Without limiting the foregoing, Takeda
shall keep Amylin regularly and fully informed regarding the Development of
Products in the Field in the Territory by Takeda and its Affiliates and
sublicensees, including information regarding the status of Clinical Trials,
filing of regulatory filings and receipt of Regulatory Approval with respect to
Products in the Field in the Territory.

 

3.9          Compliance with Laws.  Each Party will conduct its portion of the
Development Program using Commercially Reasonable Efforts, in a good scientific
manner and in compliance in all material respects with all requirements of
Applicable Laws, including cGCPs, cGLPs and cGMPs, to achieve the objectives of
the Development Program efficiently and expeditiously.

 

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3.10        Cooperation.  Each Party will use Commercially Reasonable Efforts to
provide the other Party with all reasonable assistance and take all actions
reasonably requested by such other Party, without changing the allocation of
responsibilities assigned in the Development Plan, that are necessary or
desirable to enable the other Party to comply with the terms and intent of this
Agreement.  Each Party further agrees to cooperate with any inspection by any
Regulatory Authority, including, but not limited to, any inspection prior to
Regulatory Approval for any Product in the Field in any country in the
Territory.  The Parties will use Commercially Reasonable Efforts to conduct
Development of and obtain Regulatory Approval for Products in the Field in the
Territory, as provided in the Development Plan, for the purpose of maximizing
the commercial value of the Products in the Field in the Territory.

 

3.11        Development Costs.

 

3.11.1     Responsibility for Development Costs.  Throughout the Term of this
Agreement, Takeda shall bear eighty percent (80%) and Amylin shall bear twenty
percent (20%) of all U.S. Development Costs, except in the case of U.S.
Development Costs of any Regulatory Approval Clinical Trial that is a
cardiovascular safety study that becomes required by the FDA and is not already
included in the then-current Development Plan at the time it becomes required by
the FDA (a “CV Safety Study”).  With respect to any CV Safety Study, Takeda
shall bear [***] percent ([***] %) and Amylin shall bear [***] percent ([***] %)
of all such U.S. Development Costs; provided, however, if the U.S. Development
Costs of such CV Safety Study exceed, or are anticipated to exceed, [***]
Dollars (US $[***]): (i) Takeda shall, upon Amylin’s written request, be
obligated to pay all U.S. Development Costs that exceed [***] Dollars (US
$[***]); and (ii) Amylin shall, within [***] following the database lock or
earlier termination of the CV Safety Study (the “Database Lock Date”), reimburse
Takeda an amount equal to [***] percent ([***] %) of such U.S. Development Costs
that exceeded [***] Dollars (US $[***]), plus simple interest calculated at
three-month LIBOR (the “Loan”). Amylin shall be required to pay at least [***] 
([***] %) of the Loan upon each of the [***] anniversary of the Database Lock
Date and the [***] anniversary of the Database Lock Date; provided, however,
Takeda shall have the right to set-off, in any calendar year, against any
payments due from Takeda to Amylin under this Agreement by the amount that
Amylin is obligated to pay Takeda for reimbursement of the Loan during such
calendar year.  For the avoidance of doubt, Amylin may reimburse Takeda the full
amount of the Loan prior to the due date with no prepayment penalty. Takeda
shall bear one hundred percent (100%) of all Development Costs that are not U.S.
Development Costs. The ODC shall identify in the Development Plan: (i) U.S.
Development Costs; and (ii) Development Costs that are not U.S. Development
Costs; provided, however, all Development Costs that are deemed to be necessary
for the approval of an NDA filed with the FDA shall be considered U.S.
Development Costs.

 

3.11.2     Calculation of Development Costs.  For purposes of calculating
Development Costs, the FTE rate shall be [***] Dollars (US$[***]) per annum. The
FTE rate shall be valid through and including [***].  The FTE rate shall be
adjusted [***] as of [***]  effective as of [***]  in accordance with the annual
percentage change in the [***], except as otherwise agreed by the Parties. 
Development Costs shall only include the FTE rates of employees actually
performing work under the Development Plan. General management and

 

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supervisory overhead costs incurred by each Party in connection with the
performance of this Agreement shall not be included in the Development Costs
(and shall be borne solely by the Party incurring such costs).  The Parties
shall establish a mutually agreed upon format for reporting FTEs that are
included within Development Costs.

 

3.11.3     Development Costs Exceeding Binding Budget.  Each Party agrees to use
its Commercially Reasonable Efforts to complete the activities contemplated by a
Binding Budget and to do so within the amounts budgeted.  The Parties
acknowledge that actual expenditures may differ from budgeted amounts, and
accordingly agree that the aggregate amount actually spent by a Party may be up
to [***] percent ([***] %) higher than the amount specified in the Binding
Budget.  In the event a Party’s Development Costs in the aggregate exceed the
amount budgeted in any Binding Budget by more than [***] percent ([***] %), the
ODC shall determine if such excess amount is reasonable under the
circumstances.  If the ODC determines such excess amounts are reasonable, such
amounts shall be deemed Development Costs; otherwise, the excess shall be the
responsibility of that Party.

 

3.11.4     Payment.  Within [***] after the end of each calendar quarter, each
Party will provide a written report to the other Party setting forth in
reasonable detail the recorded Development Costs relating to such quarter (each,
a “Quarterly Report”).  Within [***]  after the end of such calendar quarter,
the Party responsible for reimbursement of Development Costs to the other Party
will provide to the other Party a written report based upon such Quarterly
Reports (each, a “Payment Report”) reconciling the Development Costs of each
Party and setting forth the amount payable in accordance with this
Section 3.11.  The amount due, as set forth in the applicable Payment Report,
shall be paid concurrently with providing such Payment Report.

 

3.11.5     Corrections.  In the event either Amylin or Takeda discover a need
for correction in calculating the amount of Development Costs incurred by such
Party during any previous calendar quarter, it will promptly notify the other
Party of such discovery.  The Parties will then discuss the validity and
appropriateness of the correction.  If the Parties agree that such correction
should be made and collectively verify the amount to be corrected, then such
amounts shall be included in the following quarterly reconciliation between the
Parties as set forth in Section 3.11.4 hereof; provided, however, that only
corrections for expenses that have occurred in the previous [***] prior to the
date of the notice described in the first sentence of this paragraph shall be
eligible for correction.  If the Parties do not agree on the validity or
appropriateness of the requested correction, then the OSC will be responsible
for deciding the issue.

 

3.12        Audit.  During the period of the Development Program, each Party
shall have the right to cause an independent, certified public accounting firm
(the “Auditor”) reasonably acceptable to the other Party to audit the other
Party’s records relating to Development Costs to confirm the amount of the
Development Costs reflected in the Quarterly Reports and Payment Reports
contemplated by Section 3.11.4. The audited Party may require such Auditor to
sign a confidentiality agreement in form and substance reasonably satisfactory
to the Party being audited.  Such audit right may be exercised during normal
business hours upon reasonable prior written notice to the audited Party;
provided that such audit right may be exercised no more than once in any [***]
period and no more than once with regard to any given [***].

 

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The Auditor will prepare a report of the results of the audit and promptly
deliver a copy to each Party. The Parties may make inquiries of the Auditor to
clarify the contents of the report and the Auditor’s response will be made to
both Parties.  As appropriate, prompt adjustments to payments made pursuant to
Section 3.11.4 shall be made by the Parties to reflect the results of such
audit. The Party to whom payment is owed will issue an invoice to the other
Party. Such invoice will be paid within [***] of receipt. The auditing Party
shall bear the full cost of such audit unless such audit discloses an
over-reporting by the audited Party of more than [***] percent ([***] %) of the
amount of Development Costs for a given calendar quarter, in which case, the
audited Party shall bear the full cost of such audit.

 

4.             REGULATORY

 

4.1          Conduct of Regulatory Activities.  All regulatory activities for
obtaining Regulatory Approval of Products in the Field in the Territory shall be
conducted by and on behalf of the Parties in compliance with the provisions of
this Agreement.  Takeda shall: (i) be responsible for all activities relating to
preparing, making submissions for, owning and maintaining Regulatory Approvals,
including supplements and amendments thereto, with respect to Products in the
Field in the Territory; (ii) use Commercially Reasonable Efforts to obtain
Regulatory Approval of the Products in the Field in the Territory; and
(iii) lead discussions and meetings with all Regulatory Authorities regarding
Licensed Compounds or Products in the Field in the Territory, subject to the
terms of this Section 4.1; provided, however, a representative of Amylin shall
be entitled to participate in any such discussions and meetings with Regulatory
Authorities, and, if an appropriate Amylin representative is requested by Takeda
to attend a discussion or meeting with the FDA regarding Licensed Compounds or
Products in the Field in the Territory, Amylin will use Commercially Reasonable
Efforts to arrange for such individual to participate in such discussions or
meetings.  The ODC shall determine and set forth in the Development Plan the
respective responsibilities of each of the Parties for all regulatory activities
with respect to Products in the Field in the Territory other than the regulatory
activities described in the immediately preceding sentence.  Each Party shall
conduct all regulatory activities for which it is the responsible Party in
accordance with the Development Plan, using Commercially Reasonable Efforts, and
in compliance in all material respects with all Applicable Laws.  Upon request
by the Party responsible for the applicable regulatory activities, the other
Party shall provide reasonable assistance to such responsible Party with regard
to such regulatory activities under this Agreement.  The Party responsible for
the applicable regulatory activities agrees to consult with the other Party
regarding, and keep the other Party regularly and fully informed of, the
preparation, and Regulatory Authority review and approval, of submissions and
communications with Regulatory Authorities with respect to Products in the Field
in the Territory for which such Party is responsible.  Each Party agrees to
consider in good faith any comments or suggestions made by the other Party with
respect to such matters.  In addition to the information required to be provided
to the other Party in other provisions of this Agreement, each Party shall
timely provide the other Party with summaries of its communications and
correspondence with the Regulatory Authorities in the Territory, including with
respect to Product safety and manufacturing issues.  Amylin shall transfer to
Takeda responsibility for regulatory activities with respect to each Product at
the next specified phase of development (for example, upon advancement of a
Product from Phase 2 Clinical Trials to Phase 3 Clinical Trials). In addition,
Amylin shall either: (a) transfer to Takeda its current INDs related to Amylin
Licensed Compounds that are not contained in an Excluded Product; or (b) permit
Takeda to

 

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reference Amylin’s INDs related to Amylin Licensed Compounds that are contained
in an Excluded Product, in each case pursuant to a mutually agreed upon timeline
set forth in the Development Plan, which shall be not later than [***] in
advance of the first to occur of (1) the start of the next Clinical Trial for
such Amylin Licensed Compound; and (2) a significant meeting with the FDA
regarding such Amylin Licensed Compound.

 

4.2          Right of Cross-Reference.  Takeda hereby grants Amylin the right to
access and cross-reference all filings with and submissions to the Regulatory
Authorities with respect to Products in the Field in the Territory as may be
necessary or useful for Amylin to obtain Regulatory Approval with respect to
Excluded Products.  Amylin hereby grants Takeda the right to access and
cross-reference all filings with and submissions to the Regulatory Authorities
with respect to Excluded Products as may be necessary or useful for Takeda to
obtain Regulatory Approval with respect to Products in the Field in the
Territory.

 

4.3          Regulatory Inspection or Audit.

 

4.3.1       Cooperation.  If a Regulatory Authority desires to conduct an
inspection or audit of or sends a communication  to Takeda or Amylin or any
Third Party engaged by either Party to perform activities under the Development
Plan or Commercialization Plan with regard to any Product or this Agreement,
Takeda and Amylin each agrees to cooperate with the Regulatory Authority and the
other Party during such inspection or audit, including by allowing, to the
extent practicable, a representative of the other Party to be present during the
applicable portions of such inspection or audit.  Following receipt of the
inspection or audit observations of the Regulatory Authority (a copy of which
the Party will immediately provide to the other Party), the responsible Party
will prepare the response to any observation that concerned this Agreement.  The
other Party agrees to fully cooperate when it prepares such a response,
including by providing to the responsible Party, within [***]  after its
request, such information and documentation in the Party’s possession as may be
necessary for the responsible Party to prepare such response.  Before submitting
the response to the Regulatory Authority, the responsible Party agrees to give
the other Party an opportunity to comment on it.

 

4.3.2       Notice.  Each Party (and its Third Party subcontractors) shall
notify the other Party within [***] of receipt of notification from a Regulatory
Authority of the intention of such Regulatory Authority to audit or inspect a
Party’s facilities with respect to any Product, including facilities being used
for manufacture of any Product.  Each Party (and its Third Party subcontractors)
shall also provide the other Party with copies of any written communications
received from Regulatory Authorities with respect to such facilities within
[***] of receipt.  Such Party shall provide the other Party with an opportunity
to review and provide input on any proposed response by such Party (or Third
Party subcontractor) to such communications.

 

4.4          Pharmacovigilance.  Takeda shall be responsible, at its own
expense, for the establishment and maintenance of the global safety database for
Products in the Field in the Territory throughout the Development and
Commercialization of such Products.  The method and timing of the transfer of
legacy safety information for Products in the Field in the Territory Controlled
by Amylin shall be agreed upon by the Parties.  Each Party shall cooperate (at
its own cost and expense), and shall cause its Affiliates and sublicensees to
cooperate, in implementing a

 

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pharmacovigilance mutual alert process with respect to Products to comply with
all Applicable Laws and applicable obligations of Regulatory Authorities.  The
Parties shall enter into a pharmacovigilance agreement as soon as reasonably
practical after the Effective Date, but no later than [***] prior to the filing
of Takeda’s first IND for any Product, on terms no less stringent than those
required by ICH guidelines, Applicable Laws and applicable local regulatory
requirements, including: (i) providing detailed procedures regarding the
maintenance of core safety information and the exchange of safety data relating
to Products worldwide within appropriate timeframes and in an appropriate format
to enable each Party to meet both expedited and periodic regulatory reporting
requirements; and (ii) ensuring compliance with the reporting requirements of
all applicable Regulatory Authorities on a worldwide basis for the reporting of
safety data in accordance with standards stipulated in the ICH guidelines, and
all Applicable Laws and applicable regulatory requirements regarding the
management of safety data.

 

4.5          Recalls and Product Quality and Safety.  The Parties shall mutually
agree, on an expedited basis, upon issues that relate to Product quality and
safety and any response by the Parties to such issues, including the decision to
recall or withdraw a Product from the market, discontinue a Clinical Trial, or
make any public statement about a product defect, quality issue or the safety of
a Product; provided, however, Takeda will have final decision-making authority
if: (i) mutual agreement cannot be reached on a Product quality or safety issue,
including (a) a decision to recall or withdraw a Product from the market, or
(b) a decision regarding safety issues to be reported to any applicable
Regulatory Authority, including individual adverse events or other matters
affecting the health, safety or welfare of a patient, or (ii) an immediate
response to a Regulatory Authority is required and there is no reasonable
opportunity to discuss the response with Amylin.  Any decision made in good
faith by a Party pursuant to Section 4.5(i) or (ii) shall not be subject to the
dispute resolution provisions set forth in Sections 15.2 and 15.3. For the
avoidance of doubt, nothing contained in this Section 4.5 is intended to prevent
Amylin from having final decision making authority for: (1) a decision to recall
or withdraw an Amylin Licensed Compound contained in an Excluded Product from
the market; or (2) a decision regarding a safety issue relating to an Amylin
Licensed Compound contained in an Excluded Product to be reported to any
applicable Regulatory Authority, including individual adverse events or other
matters affecting the health, safety or welfare of a patient.

 

5.             COMMERCIALIZATION

 

5.1          Commercialization Activities. Takeda shall be responsible for
Commercializing Products in the Field in the Territory, including conducting any
Post-Approval Clinical Studies, at its own expense, subject to the terms and
conditions of this Agreement and in compliance in all material respects with
Applicable Laws. Takeda shall be responsible for all Commercialization Costs.
Takeda shall use Commercially Reasonable Efforts to Commercialize Products in
the Field in the Territory in accordance with the Commercialization Plan and the
terms of this Agreement, subject to Amylin’s co-Commercialization of Products
pursuant to Section 5.3, and the terms of any Co-Commercialization Agreement. 
Except as otherwise provided for in Section 5.3 and any Co-Commercialization
Agreement, Takeda shall have the sole right and responsibility for all
activities relating to Commercialization of all Products in the Field in the
Territory including, without limitation: (i) booking all sales of Products;
(ii) determining the price of all Products; (iii) sale and distribution of all
Products, as described in Section 5.4 below; and (iv) conducting all Product
marketing activities, including the creation

 

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and approval of marketing programs and promotional materials; provided, however,
that Amylin shall not be required to use any marketing programs or promotional
materials that it reasonably believes are not in compliance with Applicable
Laws, including any guidelines issued by the Office of Inspector General of the
Department of Health and Human Services.  Takeda may request that Amylin perform
Commercialization activities. If Amylin agrees to perform such Commercialization
activities, Takeda shall reimburse Amylin at the then-current FTE rate (as
defined in Section 3.11.2, or at another FTE rate mutually agreed upon by the
Parties) for Amylin’s internal personnel costs relating to the performance of
such activities (excluding activities necessary to support its Detailing
requirements under Section 5.3, if any), plus any costs paid by Amylin to a
Third Party in conducting such activities. Takeda shall keep Amylin regularly
informed regarding the Commercialization Plan for each Product and all material
activities with respect to Products in the Field in the Territory.

 

5.2          Commercialization Plan.  The Commercialization of Products in the
Field in the Territory shall be governed by a comprehensive plan for all
proposed Commercialization activities for such Products, which plan shall
describe the pre-launch, launch and subsequent Commercialization activities,
budget and sales forecasts for each Product (including, if available,
advertising, education, planning, marketing, sales force training and
allocation, distribution, and pricing and reimbursement to the extent permitted
by Applicable Laws) (the “Commercialization Plan”). Takeda shall be responsible
for the creation and implementation of the Commercialization Plan, subject to
review of the conduct and progress of Commercialization of Products in the Field
in the Territory by the OCC pursuant to Section 2.3.  The outline of the first
Commercialization Plan shall be completed within [***] after the Effective
Date.  Takeda shall submit the Commercialization Plan for each Product and any
amendments thereto, to the OCC for review pursuant to Section 2.3. The
Commercialization Plan shall be reviewed and, if necessary, amended, no less
than annually by Takeda for OCC review.

 

5.3          Amylin Co-Commercialization Option.  Subject to the terms and
conditions contained in this Section 5.3, Takeda hereby grants to Amylin an
option to co-Commercialize with Takeda the first two (2) Products containing
different clinically active ingredients that have received Regulatory Approval
by the FDA in the United States, and any additional Products that receive
Regulatory Approval by the FDA, which contain the identical clinically active
ingredient(s) as either of the first two (2) Products (the “Co-Commercialization
Option”). Amylin may exercise its Co-Commercialization Option with respect to a
Product by providing written notice to Takeda no later than [***] following the
unblinding of the first Phase 3 Clinical Trial of such Product in the United
States. Takeda shall provide Amylin with Takeda’s then current fully-burdened
PDE rate upon the unblinding of the first Phase 3 Clinical Trial of such Product
in the United States. Upon the timely exercise by Amylin of its
Co-Commercialization Option, and within [***] thereafter, the Parties shall
negotiate in good faith and enter into a co-Commercialization agreement (the
“Co-Commercialization Agreement”) on mutually agreeable terms, including the
terms set forth in this Section 5.3 and Exhibit D; provided, however, that if
the Parties fail to enter into a Co-Commercialization Agreement within such
timeframe, the terms set forth in this Section 5.3 and Exhibit D shall govern
the co-Commercialization of such Product as if the Parties had entered into a
Co-Commercialization Agreement. The Parties agree that pursuant to the
Co-Commercialization Option, and subject to Takeda’s Commercialization rights
set forth in Section 5.1: (i) Amylin will be responsible for participating in
activities of the OCC, including providing input into the

 

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development of the Commercialization Plan, performing Details and conducting
such other activities necessary to support its PDE requirements; (ii) Amylin
will provide no more than [***] percent ([***] %) of the Commercialization
effort as measured by PDEs for either Product; (iii) Takeda shall reimburse
Amylin for PDEs performed by Amylin at [***] percent ([***] %) of Takeda’s then
current fully-burdened cost for a PDE (which fully-burdened PDE cost, as of the
Effective Date, is [***] Dollars (US $[***])); and (iv) the term of the
Co-Commercialization Agreement shall be [***], with a [***] extension, (a) upon
mutual agreement of the Parties, or (b) at Amylin’s option if, during
discussions regarding the [***] extension, Takeda expresses its intent to use a
contract sales organization during such [***] extension.  Upon exercise of the
Co-Commercialization Agreement, or upon agreement by Amylin to perform any
Commercialization activities at Takeda’s request and in accordance with
Section 5.1, Amylin shall use Commercially Reasonable Efforts to Commercialize
the Products in the Field in the United States in accordance with the terms and
conditions of this Agreement, the Co-Commercialization Agreement (as
applicable), in compliance in all material respects with Applicable Laws, and in
accordance with any Amylin manufacturing responsibilities pursuant to Article 6
(including any supply agreements relating thereto).  For purposes of
clarification, notwithstanding the exercise of the Co-Commercialization Option
or the execution of the Co-Commercialization Agreement, Takeda shall at all
times during the Term remain obligated to pay the applicable amounts specified
under Article 8 with respect to each Product (whether or not such Product is
co-Commercialized by Amylin in the United States).

 

5.4          Sales and Distribution. Notwithstanding the exercise by Amylin of
its Co-Commercialization Option with respect to a Product pursuant to
Section 5.3, Takeda shall have the sole right and responsibility for handling
all returns, order processing, invoicing and collection, distribution (including
importing, exporting, transporting, customs clearance, warehousing, invoicing,
handling and delivering Products to customers), and inventory and receivables
for the Products in the Field in the Territory. Amylin shall not accept orders
for the purchase of a Product from Third Parties, or make sales of Product to
Third Parties in the Field in the Territory for its own account or for Takeda’s
account.  If Amylin receives any order for a Product in the Field in the
Territory, it shall refer such orders to Takeda for acceptance or rejection.
Takeda shall have the sole right and responsibility for: (i) negotiating,
establishing and/or modifying the terms and conditions regarding the sale of the
Product in the Field in the Territory, including any terms and conditions
relating to or affecting (a) the price at which the Product shall be sold,
(b) discounts available to any Third Party payers (including, without
limitation, managed care providers, indemnity plans, unions, self insured
entities, and government payer, insurance or contracting programs such as
Medicare, Medicaid, or the U.S. Dept. of Veterans Affairs, or similar programs
located in other countries of the Territory), (c) discounts attributable to
payments on receivables, (d) distribution of the Product, and (e) credits, price
adjustments, or other discounts and allowances to be granted or refused; and
(ii) all activities relating to government price reporting with respect any
Product in the Field in the Territory.

 

6.             MANUFACTURING

 

6.1          Manufacture and Supply of Licensed Compounds and Products.  The
Development Plan shall include mutually agreed upon plans for manufacture of
Products (and

 

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Licensed Compounds therein) for use in Development activities.  Amylin shall be
responsible for the manufacture and provision of clinical supplies for [***] 
for each Product; provided, however, Takeda shall have: (i) the option, at any
time, to manufacture clinical supplies; and (ii) the right to select (a) the
Product formulation and packaging configuration for Phase 3 Clinical Trials,
(b) raw material suppliers, and (c) manufacturing and release sites.  The
Parties shall negotiate in good faith and enter into a mutually agreed upon
manufacturing and supply agreement for the provision of clinical supplies at
[***], and a separate quality agreement relating to the provision of clinical
supplies, each within [***] after the Effective Date.  The manufacturing and
supply agreement for the provision of clinical supplies shall contain terms and
conditions relating to capital investments, recalls, product liabilities, and
any such other terms and conditions mutually agreeable to the Parties. 
Following the Effective Date, Amylin and Takeda shall discuss and determine
responsibility for manufacture of Products (and Licensed Compounds therein) for
commercial use in the Field in the Territory taking into account capabilities
and existing manufacturing relationships.  Within [***] after the Effective
Date, or within a timeframe otherwise mutually agreed to by the Parties, the
Parties shall negotiate in good faith and enter into a mutually agreed upon
manufacture and supply agreement for the provision of commercial Product at
[***]  and a separate quality agreement relating to the provision of commercial
Product.  Such manufacturing and supply agreement shall contain terms and
conditions relating to obsolescence, safety stock, capital investments, recalls,
product liabilities, and any such other terms and conditions mutually agreeable
to the Parties; provided, further, the price charged for Products (or active
pharmaceutical ingredient) supplied by either Party to the other Party shall be
equal to the Cost of Goods of such Products (or active pharmaceutical
ingredient), without mark-up.   For the avoidance of doubt, the Parties
acknowledge that Amylin is not a contract manufacturing organization, and will
be entering into contractual agreements with various Third Party contract
manufacturing organizations to perform Amylin’s manufacturing and supply
responsibilities under this Section 6.1.  Accordingly, the manufacturing and
supply agreements to be entered into between Amylin and Takeda pursuant to this
Section 6.1 shall be “pass-through” agreements whereby Amylin will pass through
the terms and conditions of its manufacturing and supply agreements with Third
Party contract manufacturing organizations.  Amylin shall use Commercially
Reasonable Efforts to ensure inclusion of the terms and conditions identified in
this Section 6.1 in its manufacturing and supply agreements with Third Party
contract manufacturing organizations.

 

7.             GRANT OF RIGHTS

 

7.1          License Grants.

 

7.1.1       License to Takeda.  Subject to the terms and conditions of this
Agreement, Amylin hereby grants to Takeda an exclusive (even as to Amylin,
except as provided in this Section 7.1.1), worldwide, royalty-bearing license,
with the right to sublicense in accordance with Section 7.2, under the Amylin
Technology to research, develop, make, have made, distribute, use, sell, have
sold, offer for sale, import, export and otherwise Commercialize the Licensed
Compounds and Products, including the Licensed Compounds and Products relating
to any New Project for which Takeda is the Proposing Party under Section 3.5.2,
in the Field in the Territory during the Term; provided, however, subject to the
terms and conditions of

 

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this Agreement, Amylin shall retain such rights under the Amylin Technology as
are necessary to: (i) research, develop, make, have made, distribute, use, sell,
have sold, offer for sale, import and export Excluded Products (and the Licensed
Compounds contained therein, solely as they relate to the Excluded Products);
(ii) perform its obligations under this Agreement, including the Development
(Article 3) and manufacturing (Section 6.1) activities to be performed by Amylin
under the Development Plan; (iii) research, develop, make, have made,
distribute, use, sell, have sold, offer for sale, import and export Licensed
Compounds and Products under any New Project pursuant to Section 3.5.2; and
(iv) perform the Commercialization activities of Amylin, if any, under
Section 5.1, Section 5.3 and the Co-Commercialization Agreement (Exhibit D).

 

7.1.2       License to Amylin.  Subject to the terms and conditions of this
Agreement including Articles 3 and 4, and Sections 5.1, 5.3, 6.1, 7.4.2, 7.4.3
and 7.4.4(b), Takeda hereby grants to Amylin an exclusive (except as to Takeda),
worldwide, royalty-free license, with the right to sublicense to its Affiliates
in accordance with Section 7.2, under the Takeda Technology in each case solely
to: (i) perform its obligations under this Agreement, including the Development
(Article 3) and manufacturing (Section 6.1) activities to be performed by Amylin
under the Development Plan; (ii) research, develop, make, have made, distribute,
use, sell, have sold, offer for sale, import and export Licensed Compounds and
Products under any New Project pursuant to Section 3.5.2; and (iii) perform the
Commercialization activities of Amylin, if any, under Sections 5.1 and 5.3, and
the Co-Commercialization Agreement (Exhibit D).

 

7.1.3       Joint Licenses.  Subject to the terms and conditions of this
Agreement including Articles 3 and 4, and Sections 5.1, 5.3, 6.1, 7.2.1, 7.4.1,
7.4.2, 7.4.3, Amylin hereby grants to Takeda an exclusive (except as to Amylin),
worldwide, royalty-bearing, license, with the right to sublicense to its
Affiliates and Third Parties in accordance with Section 7.2, under the Joint
Inventions and Joint Patents, and Takeda hereby grants to Amylin an exclusive
(except as to Takeda), worldwide, royalty-free, license, with the right to
sublicense to its Affiliates in accordance with Section 7.2, under the Joint
Inventions and Joint Patents, in each case solely to research, Develop, make,
have made, distribute, use, sell, offer for sale, import, export and
Commercialize the Licensed Compounds or Products in the Field in the Territory
during the Term in accordance with this Agreement. During the Term, either Party
may use the Joint Inventions and Joint Patents outside the scope of this
Section 7.1.3 upon obtaining the prior written consent of the other Party, which
consent shall not be unreasonably withheld or delayed.  Upon expiration of the
Term, either party may use the Joint Inventions and Joint Patents outside the
scope of this Section 7.1.3 without taking any further action.

 

7.2          Sublicensing; Subcontracting.

 

7.2.1       Sublicensing.  Each Party shall have the right to grant to its
Affiliates sublicenses of the rights granted to such Party under Sections 7.1.1,
7.1.2 and 7.1.3.  Takeda shall have the right to grant to Third Parties
sublicenses through multiple tiers of sublicense of the rights granted to Takeda
under Section 7.1.1 or 7.1.3; provided, however, that Takeda shall not grant to
Third Parties any sublicense of the rights granted to Takeda under Section 7.1.1
or 7.1.3 with respect to any Licensed Compound or Product in the Field in the
United States without Amylin’s prior written consent, which consent shall not be
unreasonably withheld or delayed.  Except to the extent the Parties otherwise
agree in writing, any sublicense agreement

 

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must be consistent in all material respects with the terms and conditions of
this Agreement.  The Party granting a sublicense of the rights granted to it by
the other Party under this Agreement shall use Commercially Reasonable Efforts
to enforce the terms of such sublicense.  Within [***]  after execution or
receipt thereof, as applicable, Takeda shall provide Amylin with a full and
complete copy of each sublicense agreement with a Third Party regarding the
sublicense of rights granted under Section 7.1.1 or 7.1.3 (provided that Takeda
may redact any information contained therein that is not necessary to disclose
to ensure compliance with this Agreement), and shall deliver copies of all
reports (including reports relating to royalties and other payments) relating to
Products received by Takeda from such sublicensees.

 

7.2.2       Subcontracting.  Except as set forth in Sections 1.78 and 5.3
regarding the use of contract sales organizations, each Party shall also have
the right to contract with one or more of its Affiliates or Third Parties to
perform certain of its Development obligations or Commercialization obligations;
provided such Party shall remain responsible and liable for the performance and
payment of such Affiliates and Third Parties.  However, each Party’s right to
contract with any Affiliate or Third Party as permitted by this Section 7.2.2 is
subject to the following requirements: (i) none of the other Party’s rights
hereunder shall be diminished or otherwise adversely affected as a result of
such contracting; and (ii) each such Affiliate and Third Party shall undertake
in writing obligations of confidentiality, publication and non-use regarding
Confidential Information (to the extent Confidential Information will be
disclosed to such Affiliate or Third Party), and obligations regarding ownership
of Inventions, which are substantially the same as those undertaken by the
Parties under this Agreement.

 

7.3          In-License Agreements.

 

7.3.1       Generally.  Takeda acknowledges that the rights granted by Amylin to
Takeda under this Article 7 with respect to any Amylin Technology licensed or
otherwise conveyed to Amylin under an In-License Agreement are subject to the
applicable terms and conditions of such In-License Agreement.  Takeda agrees to
comply directly with the obligations of Amylin set forth in the In-License
Agreements (including the obligations of the following agreements under which
sublicenses of intellectual property rights have been granted pursuant to the
In-License Agreements: (i) License Agreement between The Rockefeller University
and Amgen, Inc., dated April 13, 1995, as amended; and (ii) Non-Exclusive
License Agreement between The Regents of the University of California and
Amgen, Inc., dated July 13, 2005) that arise as a result of the activities of
Takeda and its Affiliates and sublicensees under this Agreement.  In the event
that any other party to an In-License Agreement notifies Amylin of a default or
breach under the applicable In-License Agreement related to any failure by
Takeda or its Affiliates or sublicensees to perform any obligation or covenant
under such In-License Agreement, Amylin shall have the right, but not the
obligation, to take such actions as reasonably necessary or appropriate to cure
such default or breach, and Takeda shall promptly reimburse Amylin for all costs
and expenses actually incurred by Amylin solely as a result of such default or
breach by Takeda or its Affiliates or sublicensees.  Amylin shall have no
liability to Takeda for any termination or modification of any In-License
Agreement arising out of or resulting from the failure of Takeda or its
Affiliates or Sublicensees to abide by, comply with or perform under the terms,
conditions or obligations of such In-License Agreement.

 

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7.3.2       Covenant Not to Sue Under Amgen Agreement.  Takeda hereby covenants
that it and its Affiliates, sublicensees and assignees shall not sue Amgen or
its affiliates and assignees for infringement of any Amylin Patents, which are
licensed to Amylin by Amgen under the Amgen Agreement, with respect to the
non-commercial activities permitted under the Amgen Agreement of Amgen, its
Affiliates and its permitted assignees using Amylin Licensed Compounds and
Products in the Territory for any human uses, including therapeutic,
prophylactic, palliative and diagnostic uses, for impairment of cognition,
including Alzheimer’s disease, Down’s syndrome and age-related cognitive
decline, on and after the Effective Date.

 

7.3.3       Agreement Under UM Agreement.  Takeda hereby agrees to enter into an
agreement in the form of Exhibit C to the UM Agreement.

 

7.4          Other Agreements.

 

7.4.1       Reservation of Rights by Amylin.  Subject to the limitations
contained in Section 7.4.3, Amylin hereby expressly reserves the right to
practice, and to grant licenses under, the Amylin Technology except to the
extent Takeda has been granted an exclusive license (except as to Amylin) under
Section 7.1.1.  Without limiting the foregoing, Amylin retains: (i) the
exclusive right to research, develop, make, have made, distribute, use, sell,
offer for sale, import or export the Excluded Products (and the Amylin Licensed
Compounds contained therein, solely as they relate to the Excluded Products);
and (ii) [***].

 

7.4.2       Reservation of Rights by Takeda.  Except with respect to the
exclusive license (except as to Takeda) granted to Amylin pursuant to
Section 7.1.2, Takeda hereby expressly reserves the right to practice, and to
grant licenses under, the Takeda Technology for any and all purposes including
use of such rights outside the Field.

 

7.4.3       Other Amylin Agreements.

 

(a)           Amylin agrees not to practice any Takeda Technology except
pursuant to the exclusive license (except as to Takeda) granted to Amylin
pursuant to Section 7.1.2.

 

 

(b)           Amylin will not, itself or through its Affiliates, or through the
grant of any license under the Amylin Technology to Third Parties by Amylin or
its Affiliates: (i) develop, make, have made, distribute, use, sell, offer for
sale, import or export any of the Amylin Licensed Compounds or Products in any
indication outside the Field (except with respect to central nervous system
indications, for which Amylin has no right to license or sublicense the Amylin
Licensed Compounds or Products to Takeda as of the Effective Date [***], or as
otherwise expressly permitted in this Agreement); (ii) research, develop, make,
have made, distribute, use, sell, offer for sale, import or export any Analogs
of Licensed Compounds that are not already Licensed Compounds set forth in
Exhibit E (except with respect to central nervous system indications, for which
Amylin has no right to license or sublicense the Amylin Licensed Compounds,
Analogs of Amylin Licensed Compounds, or Products to Takeda as of the Effective
Date [***], or except as otherwise permitted under this Section 7.4.3(c) and
Sections 3.3

 

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and Section 3.5.2); or (iii) research, develop, make, have made, distribute,
use, sell, offer for sale, import or export any Takeda Y-family Agonist unless
and until any of the following have occurred, (A) such Takeda Y-family Agonist
has been added as a Takeda Licensed Compound pursuant to Section 3.4, (B) such
Takeda Y-family Agonist has become part of the Development Plan pursuant to
3.5.2, or (C) Amylin is free to develop or commercialize the Takeda Y-family
Agonist pursuant to the last sentence of Section 3.5.2(d).

 

(c)           Subject to Amylin’s obligations under Section 3.3 and 3.5.2,
Amylin and its Affiliates and sublicensees may research, develop, make, have
made, distribute, use, sell, offer for sale, import or export any analogs of
Amylin Licensed Compounds and any Analogs of Amylin Licensed Compounds; provided
that, for the avoidance of doubt, Amylin has the sole discretion to determine
all research and development regarding analogs of Amylin Licensed Compounds or
Analogs of Amylin Licensed Compounds unless and until any of the following have
occurred, (i) such analogs of Amylin Licensed Compounds or Analogs of Amylin
Licensed Compounds have been added as Amylin Licensed Compounds pursuant to
Section 3.3, or (ii) such analogs of Amylin Licensed Compounds or Analogs of
Amylin Licensed Compounds have become part of the Development Plan pursuant to
Section 3.5.2(d).

 

7.4.4       Other Takeda Agreement.

 

(a)           Takeda agrees not to practice any Amylin Technology except
pursuant to the license expressly granted to Takeda pursuant to Section 7.1.1.

 

(b)           Takeda will not, itself or through its Affiliates, or through the
grant of any license to Third Parties by Takeda or its Affiliates research,
develop, make, have made, distribute, use, sell, offer for sale, import or
export any analogs of Amylin Licensed Compounds or Analogs of Amylin Licensed
Compounds: (i) unless and until any of the following have occurred, (A) such
analogs of Amylin Licensed Compounds or Analogs of Amylin Licensed Compounds
have been added as Amylin Licensed Compounds pursuant to Section 3.3, (B) such
analogs of Amylin Licensed Compounds or Analogs of Amylin Licensed Compounds
have become part of the Development Plan pursuant to 3.5.2, or (C) Takeda is
free to develop or commercialize the analogs of Amylin Licensed Compounds or
Analogs of Amylin Licensed Compounds pursuant to the last sentence of
Section 3.5.2(d); or (ii) unless such Analogs of Amylin Licensed Compounds are
Takeda Y-family Agonists set forth in Exhibit E.

 

(c)           Subject to Takeda’s obligations under Section 3.4 and 3.5.2,
Takeda, its Affiliates or sublicensees may research, develop, make, have made,
distribute, use, sell, offer for sale, import and export Takeda Y-family
Agonists; provided that, for the avoidance of doubt, Takeda has sole discretion
to determine all research and development regarding Takeda Y-family Agonists,
including whether to research and develop Takeda Y-family Agonists in obesity or
other therapeutic areas, unless and until such Takeda Y-family Agonists have
been added as Takeda Licensed Compounds pursuant to Section 3.4 or have become
part of the Development Plan pursuant to Section 3.5.2.

 

7.5          No Implied Licenses.  No right or license under any Patents or
Information of either Party is granted or shall be granted by implication.  All
such rights or licenses are or shall be granted only as expressly provided in
the terms of this Agreement.

 

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8.             PAYMENTS

 

8.1          Upfront Fee.  Takeda shall make a one-time, non-refundable,
non-creditable payment to Amylin of Seventy-Five Million Dollars (US$75,000,000)
within [***], not including bank holidays in Japan or the United States, after
the later of: (i) the Effective Date; or (ii) the date of Takeda’s receipt of
Amylin’s invoice and completed tax related documents (Japanese Form 3
(Application Form for Income Tax Convention), Japanese Form 17 (Attachment
Form for Limitation on Benefits (US)), and U.S. IRS Form 6166).

 

8.2          Milestone Payments.

 

8.2.1       Except as provided in Section 8.2.2 below, within [***] following
the first occurrence of each of the events set forth below for each Product
(except as expressly noted in the chart below), Takeda shall pay to Amylin each
of the non-refundable, non-creditable milestone payments set forth below
(whether such milestone is achieved by Takeda, its Affiliate or a sublicensee):

 

Milestone Event

 

Milestone Payment

 

Development Milestones

 

 

 

[***]

 

US$[***]*

 

[***]

 

US$[***]*

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

 

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[***]

 

US$[***]

 

 

[***] .Commercial Milestones for BID Products and QD Products:  These milestones
are payable only one time for each Product containing identical Licensed
Compound(s).

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

 

Commercial Milestones for QW Products: These milestones are payable only one
time for each Product containing identical Licensed Compound(s).

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

 

Sales-Based Milestones

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

[***]

 

US$[***]

 

 

Except as otherwise provided in the chart set forth above, each of the milestone
payments described in this Section 8.2.1 shall be payable one time for each
separate Product, regardless of the number of indications for which such Product
is Developed or Commercialized; provided, however, if: (i) a Product is
abandoned during Development after one (1) or more of the milestone payments
under this Section 8.2.1 has been made for such Product (a “Dropped Product”);
and (ii) another Product containing a different Licensed Compound, or
combination of different Licensed Compounds, with or without another active
ingredient, is Developed for substantially the same indications as a replacement
for such Dropped Product, then only those

 

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milestone payments under this Section 8.2.1 that were not previously made with
respect to such Dropped Product shall be payable with respect to the replacement
Product.  In the event: (a) a Product is Developed in an Alternative Delivery
System; or (b) a BID Product, QD Product or a QW Product is Developed that does
not utilize a single-injection delivery system or an Alternative Delivery
System, then the Parties shall negotiate in good faith any development,
commercial, and sales-based milestone payments and royalty rates for such
Product taking into consideration, among other things, the commercial valuation
and product profile of the Product; provided, however, if such Product has a
similar product profile and commercial valuation as a BID Product, QD Product or
QW Product, then the development, commercial, and sales-based milestone payments
and royalty rates for such Product shall be similar to those for either a BID
Product, QD Product or QW Product. For purposes of clarification, subsection
(b) of the preceding sentence is intended to apply to Products with a
presentation that requires multiple injections for each dose administration.

 

8.2.2.      Notwithstanding anything to the contrary contained in Section 8.2.1,
the following milestone payments shall apply to Products that contain a Takeda
Y-family Agonist, which milestone payments shall be paid by Takeda in accordance
with Section 8.2.1:

 

(a)               With respect to a Product that is a Takeda Y-family Agonist
Developed or Commercialized as a single agent, Takeda shall not be obligated to
make Development, Commercial or sales-based milestone payments to Amylin.

 

(b)               With respect to a Product that contains a Takeda Y-family
Agonist, and a Licensed Compound for which Development and/or Commercial
milestone payments have been made to Amylin pursuant to Section 8.2.1 (with
respect to such Licensed Compound only), Takeda shall pay in accordance with
Section 8.2.1: (i) [***] ([***] %) of new indication milestones not already paid
for by Takeda in connection with such Licensed Compound; and (ii) [***] percent
([***] %) of Commercial and sales-based milestones.

 

(c)               With respect to a Product that contains a Takeda Y-family
Agonist, in combination with OPT or an Analog of another Licensed Compound for
which Development and/or Commercial milestone payments have not been made to
Amylin pursuant to Section 8.2.1, Takeda shall pay in accordance with
Section 8.2.1: (i) [***] percent ([***] %) of all Development, Commercial and
sales-based milestones.

 

(d)               With respect to a Product that contains a Takeda Y-family
Agonist, and a Licensed Compound for which Development and/or Commercial
milestone payments have not been made to Amylin pursuant to Section 8.2.1,
Takeda shall pay in accordance with Section 8.2.1: (i) [***] percent ([***] %)
of Development, Commercial and sales-based milestones.

 

 

8.2.3.      Each Party agrees that it will not consider the milestone payment
obligations set forth in Section 8.2.2 for purposes of making Development
decisions when considering and comparing both: (i) a Product referenced in
Section 8.2.2 (containing a Takeda Y-family Agonist); and (ii) any other Product
that does not contain a Takeda Y-family Agonist.

 

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8.3                               Royalties.

 

8.3.1                     Royalty on Tier 1 Products.  Takeda shall pay to
Amylin royalties based on total annual Net Sales of each Product in the
Territory that contains only one or more Amylin Licensed Compounds (other than
OPT) as clinically active ingredients (each, a “Tier 1 Product”), at the
following rates:

 

Total Annual Net Sales

 

Royalty Rate

 

 

 

 

 

For that portion of total annual Net Sales that is less than or equal to
US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For the portion of aggregate annual Net Sales greater than US$[***]

 

[***]

%

 

8.3.2                     Royalty on Tier 2 Products.  Takeda shall pay to
Amylin royalties based on total annual Net Sales of each Product in the
Territory that contains: (i) both an Amylin Licensed Compound and either OPT or
a Takeda Licensed Compound that is a Takeda Y-family Agonist as clinically
active ingredients; provided that, for clarification, in no event shall the
calculation with respect to Combination Products set forth in the definition of
Net Sales apply to any Product under this Section 8.3.2(i); or (ii) both an
Amylin Licensed Compound that is not an Option Compound and an Amylin Licensed
Compound that is an Option Compound as clinically active ingredients, provided
the Option Compound was nominated by Amylin prior to the completion of a Phase 1
Clinical Trial (each, a “Tier 2 Product”), at the following rates:

 

Total Annual Net Sales

 

Royalty Rate

 

 

 

 

 

For that portion of total annual Net Sales that is less than or equal to
US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For the portion of aggregate annual Net Sales greater than US$[***]

 

[***]

%

 

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8.3.3                     Royalty on Tier 3 Products.  Takeda shall pay to
Amylin royalties based on total annual Net Sales of each Product in the
Territory that is not a Tier 1 Product or a Tier 2 Product (each, a “Tier 3
Product”) (which Products may include OPT or a Takeda Y-family Agonist as the
sole active ingredient) at the following rates:

 

Total Annual Net Sales

 

Royalty Rate

 

 

 

 

 

For that portion of total annual Net Sales that is less than or equal to
US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For that portion of aggregate annual Net Sales that is greater than US$[***] and
less than or equal to US$[***]

 

[***]

%

 

 

 

 

For the portion of aggregate annual Net Sales greater than US$[***]

 

[***]

%

 

8.3.4                     Royalty Term.  Royalties under this Section 8.3 shall
be payable based on total annual Net Sales of each Product on a
Product-by-Product and country-by-country basis: (i) at [***] percent ([***] %)
of the rates set forth above for a period equal to the Initial Royalty Term for
such Product in such country; and (ii) upon expiration of the Initial Royalty
Term for such Product in such country, at [***] percent ([***] %) of the royalty
rates set forth above until expiration of the Secondary Royalty Term for such
Product in such country.  Upon expiration of the Secondary Royalty Term with
respect to a Product in any country and payment in full of all amounts owed to
Amylin under this Agreement with respect to such Product in such country, the
licenses granted in Sections 7.1.1 and 7.1.3 for such Product in such country
shall become exclusive (even as to Amylin), perpetual, royalty-free, fully-paid
up and irrevocable and shall survive any expiration of this Agreement.  Set
forth on Exhibit G is an example of the royalty calculation.

 

8.4                               Payments Under In-License Agreements.  Except
as set forth in this Section 8.4, Amylin shall be responsible for making all
payments due under the In-License Agreements before and after the Effective Date
as a result of the Parties’ performance of obligations and exercise of rights
under this Agreement; provided, however, with respect to the Pacira Agreement:
(i) Amylin shall only be responsible for making payments that relate to
Davalintide; and (ii) any additional payments to be made under the Pacira
Agreement shall be paid in accordance with Section 8.5.

 

8.5                               Payments under Other Third Party License
Agreements.  In the event that the Parties elect to take a license, or otherwise
acquire rights, to Third Party intellectual property rights for Development
and/or Commercialization of Product(s) in the Field in the Territory, other than
a license or acquisition of such Third Party intellectual property rights
necessary to

 

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exercise the rights to the Amylin Technology licensed to Takeda hereunder, or
exercise the rights to the Takeda Technology licensed to Amylin hereunder, the
following shall apply: (i) each Party will pay [***] percent ([***] %) of any
up-front license fees and development milestone payments;  (ii) Takeda will pay
[***] percent ([***] %) and Amylin will pay [***] percent ([***] %) of any
(a) commercial and sales-based milestone payments, (b) royalties on Net Sales of
Products, up to a [***] percent ([***] %) royalty rate, and (c) any other costs
associated with acquiring such Third Party intellectual property rights; and
(iii) the Parties will negotiate in good faith how to share the costs of any
royalties on Net Sales of Products that exceed [***] percent ([***] %);
provided, further, for the avoidance of doubt, nothing contained in subsections
(i), (ii) or (iii) above is intended to apply to Development Costs, including
U.S. Development Costs, which shall be allocated in accordance with
Section 3.11. If a license or acquisition of rights to Third Party intellectual
property is necessary to exercise the rights to the Amylin Technology licensed
to Takeda hereunder, each Party shall be responsible for paying [***] percent
([***] %) of the up-front payments, development, commercial and sales-based
milestone payments, royalties and any other costs associated with acquiring such
Third Party intellectual property rights. If a license or acquisition of rights
to Third Party intellectual property is necessary to exercise the rights to the
Takeda Technology licensed to Amylin hereunder, Takeda shall be responsible for
paying [***] percent ([***] %) of the up-front payments, development, commercial
and sales-based milestone payments, royalties and any other costs associated
with acquiring such Third Party intellectual property rights.

 

8.6                               Bundling. Takeda hereby agrees that it will
not, nor, to the extent permitted under Applicable Law, shall it allow its
Affiliates or sublicensees to, provide a discount on Products as part of a
multiple product offering with any other products or services that: (i) are not
a normal and customary discount that Takeda would provide on other products in
its portfolio; or (ii) are unreasonably disproportionate to discounts Takeda has
provided on other products in its portfolio.  In addition, Takeda will not, nor,
to the extent permitted under Applicable Law, shall it allow its Affiliates or
sublicencees to, take into consideration any royalty payments it is obligated to
pay Amylin when determining the amount of any discounts to be provided on
Products.

 

9.                                      PAYMENT; RECORDS; AUDITS

 

9.1                               Payment; Reports.  Royalties shall be
calculated and reported for each calendar quarter.  All payments due to Amylin
under this Agreement shall be paid within [***]  after the end of each calendar
quarter, unless otherwise specifically provided herein.  Each payment shall be
accompanied by a report of Net Sales of Products by Takeda and its Affiliates
and sublicensees in sufficient detail to permit confirmation of the accuracy of
the payment made, including, on a country-by-country basis, the number of
Products sold, the gross sales and Net Sales of such Products, the royalties
payable, the method used to calculate the royalties, and the exchange rates
used.

 

9.2                               Manner and Place of Payment; Exchange Rate. 
All payments hereunder shall be payable in U.S. dollars.  All payments owed
under this Agreement shall be made by wire transfer in immediately available
funds to a bank and account designated in writing by the Party receiving the
payment, unless otherwise specified in writing by such Party.  If any currency
conversion shall be required in connection with calculating any payments
hereunder, such

 

*** Confidential Treatment Requested

 

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conversion shall be made by using the exchange rates used by the paying Party in
calculating its own revenues for financial reporting purposes, unless otherwise
agreed in writing by the Parties.

 

9.3                               Income Tax Withholding.

 

9.3.1                     Cooperation and Coordination.  The Parties acknowledge
and agree that it is their mutual objective and intent that taxes payable with
respect to their collaborative efforts under this Agreement are paid or omitted,
as appropriate, at the most favorable rate(s) proposed by the Party that would
be subject to payment of such taxes, and that they shall use their reasonable
efforts to cooperate and coordinate with each other in completing and filing
documents required under the provisions of any Applicable Laws in connection
with the making of any required tax payment or withholding payment, in
connection with a claim of exemption from, or entitlement to, a reduced rate of
withholding or in connection with any claim to a refund of or credit for any
such payment.

 

9.3.2                     Payment of Tax.  All payments made by Takeda to Amylin
pursuant to this Agreement shall be made without reduction for any taxes,
charges or remittance fees, provided that Amylin shall be responsible for any
income taxes payable by Amylin on payments made to it under this Agreement.  If
Applicable Laws require that taxes be deducted and withheld from a payment due
from Takeda to Amylin under this Agreement, Takeda shall (a) deduct those taxes
from the payment; (b) pay the taxes to the proper taxing authority; and (c) send
evidence of the obligation together with proof of payment to Amylin promptly
following that payment.  Amylin shall provide Takeda with documentation
necessary for Takeda to file an application with the applicable tax authorities
to avoid or reduce withholding or other applicable taxes under any applicable
tax treaty.

 

9.4                               Audits.  During the Term and for a period of
[***] thereafter, Takeda shall keep (and shall cause its Affiliates and
sublicensees to keep) complete and accurate records pertaining to the sale or
other disposition of Products and calculations of Net Sales and payments
required under this Agreement in sufficient detail to permit Amylin to confirm
the accuracy of all payments due to it hereunder.  Amylin shall have the right
to cause an independent, certified public accountant reasonably acceptable to
Takeda to audit such records to confirm Net Sales, royalty, milestone and other
payments for a period covering not more than the preceding [***]; provided that
any such accountant shall have previously entered into a confidentiality
agreement in terms reasonably satisfactory to Takeda limiting its disclosure of
such information to authorized representatives of the Parties or as required
under Applicable Laws. Any such inspection shall be for the sole purpose of
verifying the calculation of payments on Net Sales of the Products by Takeda,
its Affiliates or sublicensees and milestone and other payments to Amylin under
this Agreement, and to determine the reasonableness of any discounts applied to
Products.  The accountant shall disclose to Amylin the findings of the audit and
the specific details concerning any discrepancies.  No other information shall
be provided to Amylin.  Such audit rights may be exercised during normal
business hours upon reasonable prior written notice to Takeda; provided that
such audit right may be exercised no more than once in any [***] period and no
more than once with regard to any given [***].  Prompt adjustments shall be made
by the Parties to reflect the results of such audit.  Amylin shall bear the full
cost of such audit unless such audit discloses an underpayment by Takeda of more
than [***] percent ([***] %) of the amount of royalties or other payments due
under this Agreement, in which case,

 

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Takeda shall bear the full cost of such audit and shall promptly remit to Amylin
the amount of any underpayment.

 

9.5                               Late Payments.  In the event that any payment
due under this Agreement is not made when due, the payment shall accrue interest
from the date due until such payment is made in full at an interest rate equal
to the [***]; provided, however, that in no event shall such rate exceed the
maximum interest rate permitted under Applicable Laws.  The payment of such
interest shall not limit a Party from exercising any other rights it may have as
a consequence of the lateness of any payment.

 

10.                               CONFIDENTIALITY AND PUBLICATION

 

10.1                        Confidential Information.  Except to the extent
expressly authorized by this Agreement or otherwise agreed in writing by the
Parties, the Parties agree that, during the Term and for [***] ([***]) years
thereafter, the receiving Party shall keep confidential and shall not publish or
otherwise disclose and shall not use for any purpose other than as expressly
provided for in this Agreement any Information furnished to it by the other
Party or any of its Affiliates pursuant to this Agreement or owned by such other
Party or any of its Affiliates as provided herein (collectively, “Confidential
Information”).  For clarification, Amylin Technology is Confidential Information
of Amylin, Takeda Technology is Confidential Information of Takeda and Joint
Inventions and Joint Patents shall be deemed Confidential Information of both
Parties.  Each Party may use such Confidential Information only as permitted by
this Agreement.  Each Party will use at least the same standard of care as it
uses to protect proprietary or confidential information of its own (but no less
than reasonable care) to ensure that its employees, agents, consultants and
other representatives do not disclose or make any unauthorized use of the
Confidential Information.  Each Party will promptly notify the other upon
discovery of any unauthorized use or disclosure of the Confidential Information.

 

10.2                        Treatment of Manufacturing Information.  In addition
to the other provisions herein, Takeda recognizes that maintaining the
confidentiality and trade secret nature of the Manufacturing Information
requires a higher level of vigilance than other Confidential Information, and
agrees to: (i) maintain in confidence Manufacturing Information with the same
degree of care that Takeda uses to protect its own like information (but no less
than reasonable care); (ii) strictly limit access to and use of Manufacturing
Information to employees, representatives, consultants and contractors of Takeda
and its Affiliates with a need to know such information; and (iii) use
Manufacturing Information only for producing Products in the Field.  Takeda
shall ensure that any Person having access to the Manufacturing Information will
be made aware of its highly confidential nature and will agree to be bound by
confidentiality terms no less stringent than those in this Agreement.  The
obligations under this Section 10.2 shall survive and continue in effect for a
period of [***] following any expiration or termination of this Agreement,
except any obligations under this Section 10.2 that relate to Manufacturing
Information received by Amylin or Takeda under the [***] shall survive and
continue in effect for a period of [***] after expiration or termination of this
Agreement.   Each of Amylin and Takeda acknowledge and agree that Sections 10.3
and 10.4 shall apply to each Party’s Manufacturing Information, and that:
(a) Confidential Information disclosed to any contract manufacturer used by
either Party pursuant to this

 

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Agreement; and (b) any Confidential Information of the other Party received from
such contract manufacturer, shall not cause such Confidential Information to
fall within any exceptions to the definition of Confidential Information set
forth in Section 10.3 or otherwise cease to be Confidential Information of the
applicable Party for any reason.

 

10.3                        Exceptions.  Confidential Information shall not
include any information which the receiving Party can prove by written evidence:
(i) is now, or hereafter becomes, through no act or failure to act on the part
of the receiving Party, or any of its Affiliates, generally known or available;
(ii) is known by the receiving Party or any of its Affiliates at the time of
receiving such information, as evidenced by records of the receiving Party or
any of its Affiliates; (ii) is hereafter furnished to the receiving Party or any
of its Affiliates by a Third Party, as a matter of right and without restriction
on disclosure; (iv) is independently discovered or developed by or on behalf of
the receiving Party or any of its Affiliates without the use of Confidential
Information belonging to the disclosing Party; or (v) is the subject of a
written permission to disclose provided by the disclosing Party.

 

10.4                        Authorized Disclosure.  Each Party may disclose
Confidential Information belonging to the other Party as expressly permitted by
this Agreement or if and to the extent such disclosure is reasonably necessary
in the following instances:

 

10.4.1              filing or prosecuting Patents as permitted by this Agreement
with the written permission of such other Party;

 

10.4.2              regulatory filings for Products such Party has a license or
right to develop hereunder;

 

10.4.3              prosecuting or defending litigation as permitted by this
Agreement;

 

10.4.4              complying with applicable court orders or governmental
regulations;

 

10.4.5              disclosure to Affiliates, licensees, sublicensees or
potential sublicensees, employees, consultants, subcontractors or potential
subcontractors or agents of the receiving Party who have a need to know such
information in order for the receiving Party to exercise its rights or fulfill
its obligations under this Agreement; provided, however, in each case, any such
Affiliate, licensee, sublicensee or potential sublicensee, employee, consultant,
subcontractor or potential subcontractor or agent agrees to be bound by terms of
confidentiality and non-use no less restrictive than those set forth in this
Article 10;

 

10.4.6              disclosure by Amylin to the other Parties to the In-License
Agreements (and any licensor of intellectual property rights thereunder) in
order for Amylin to exercise its rights or fulfill its obligations under the
In-License Agreements, provided, in each case, that any such other Parties (and
their licensors) are bound by terms of confidentiality and non-use comparable in
scope to those set forth in this Article 10; and

 

10.4.7              disclosure to Third Parties in connection with due diligence
or similar investigations by such Third Parties, and disclosure to potential
Third Party investors in confidential financing documents, provided, in each
case, that any such Third Party agrees to be

 

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bound by similar terms of confidentiality and non-use comparable in scope to
those set forth in this Article 10.

 

Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to Sections
10.4.3 and 10.4.4, it will, except where impracticable, give reasonable advance
notice to the other Party of such disclosure and use efforts to secure
confidential treatment of such information at least as diligent as such Party
would use to protect its own confidential information, but in no event less than
reasonable efforts.  In any event, the Parties agree to take all reasonable
action to avoid disclosure of Confidential Information hereunder.

 

10.5                        Publication.  Each Party to this Agreement
recognizes that the publication of papers regarding results of and other
information regarding the activities under this Agreement, including oral
presentations and abstracts, may be beneficial to both Parties provided such
publications are subject to reasonable controls to protect Confidential
Information.  Accordingly, the ODC shall develop procedures for review and
approval of publications with respect to data generated from the Development of
Products in the Field and/or including Confidential Information, and neither
Party shall permit any publication in violation of such procedures.

 

10.6                        Publicity.  Amylin and/or Takeda may, by mutual
written agreement, issue a press release announcing the execution of this
Agreement, which shall be substantially in a form approved by the Parties prior
to execution of this Agreement.  Except with respect to such initial release or
as otherwise required by Applicable Laws (including disclosure requirements of
the U.S. Securities and Exchange Commission, the NASDAQ stock exchange or any
other stock exchange on which securities issued by a Party are traded), neither
Party shall issue an additional press release or public announcement relating to
this Agreement without the prior written approval of the other Party, which
shall not be unreasonably withheld or delayed.  In the event that a Party wishes
to refer to the other Party or the transactions under this Agreement in
promotional or other communications with prospective customers and investors,
such Party shall first provide the other Party with advance notice of such
proposed disclosure and the form, substance and intended use of such proposed
disclosure and obtain the prior written approval of the other Party to the form,
substance and intended use of such proposed disclosure.  For purposes of
clarification, after a Party has obtained the other Party’s written approval of
the form, substance and intended use of a particular reference, no further
approval of the other Party will be required for inclusion of the same reference
in future communications that are intended for the same use.  The Parties will
consult with each other on the provisions of this Agreement to be redacted in
any filings made by the Parties with the Securities and Exchange Commission or
as otherwise required by Applicable Laws.

 

10.7                        Equitable Relief.  Given the nature of the
Confidential Information and the competitive damage that would result to a Party
upon unauthorized disclosure, use or transfer of its Confidential Information to
any Third Party, the Parties agree that monetary damages would not be a
sufficient remedy for any breach of this Article 10.  In addition to all other
remedies, a Party shall be entitled to specific performance and injunctive and
other equitable relief as a remedy for any breach or threatened breach of this
Article 10.

 

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11.                               REPRESENTATIONS, WARRANTIES AND COVENANTS;
DISCLAIMER

 

11.1                        Mutual Representations and Warranties.  Each Party
represents and warrants to the other as of the Effective Date that:

 

11.1.1              It is duly organized and validly existing under the laws of
its jurisdiction of incorporation or formation;

 

11.1.2              It has full corporate or other power and is duly authorized
to execute and deliver this Agreement and to perform its obligations hereunder,
and the person(s) executing this Agreement on its behalf has been duly
authorized to do so by all requisite corporate or partnership action;

 

11.1.3              This Agreement is legally binding upon it and enforceable in
accordance with its terms;

 

11.1.4              Neither this Agreement nor such Party’s performance of its
obligations hereunder conflicts with any material agreement, instrument or
understanding, oral or written, to which it is a Party or by which it may be
bound, or violates any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it;

 

11.1.5              All of such Party’s employees or contractors acting on its
behalf pursuant to this Agreement are obligated under a binding written
agreement to assign to such Party or its designee all Inventions; and

 

11.1.6              Neither Party nor their respective Affiliates have been
debarred by the FDA under the Generic Drug Enforcement Act of 1992 (or by any
analogous agency or under any analogous law or regulation), and neither Party,
or to its Knowledge, any of its current officers or directors, have ever been
convicted of a felony under the laws of the United States for conduct relating
to the development or approval of a drug product or relating to the marketing or
sale of a drug product; provided, further, to each Party’s Knowledge, no
individual, company, partnership or other legal entity debarred by FDA or any
other governmental authority will participate in the Development or
Commercialization activities under this Agreement.

 

11.2                        Amylin Representations and Warranties.  Amylin
represents and warrants to Takeda as of the Effective Date that:

 

11.2.1              There are no pending legal actions, nor has Amylin received
any written notice regarding any pending legal actions, with respect to the
Amylin Technology;

 

11.2.2              Amylin has not received written notice of any pending or
threatened claims or litigation seeking to invalidate any Amylin Patents or
claiming that the practice of the Amylin Technology infringes the intellectual
property rights of any Third Party;

 

11.2.3              Except as set forth in the Psylin Agreement, the Shionogi
Agreement, or the In-License Agreements, Amylin has not assigned, transferred,
conveyed or otherwise encumbered its right, title and interest in the Amylin
Patents or Amylin Know-How in the Territory;

 

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11.2.4              Amylin has the full right, power, and authority to grant the
license rights granted under Article 7 hereof;

 

11.2.5              Amylin has provided to Takeda true and complete copies of
the In-License Agreements, the Psylin Agreement and the Shionogi Agreement, and
the In-License Agreements are in full force and effect and represent: (i) all
Patent in-license agreements between Amylin and Third Parties relating to the
Amylin Licensed Compounds in existence as of the Effective Date; and (ii) all
the rights and obligations of Amylin contained in or in any way relating to the
In-License Agreements;

 

11.2.6              Amylin has maintained, and has not breached in any material
respect, any currently existing agreements with Third Parties relating to any
Amylin Licensed Compounds or Products, including the In-License Agreements and
any currently existing agreements relating to the manufacture of any Amylin
Licensed Compounds to which Amylin is a Party;

 

11.2.7              (i) Amylin is the sole and exclusive owner (or, unless
otherwise set forth in an In-License Agreement, Amylin is the exclusive
licensee, with right to sublicense) of the Amylin Technology all of which are
free and clear of any liens, charges and encumbrances (other than any terms of
any In-License Agreement), and to Amylin’s Knowledge, no other Person or
governmental entity or subdivision thereof has any claim of ownership whatsoever
with respect to Amylin Technology (other than Third Parties who have ownership
rights to the Amylin Technology licensed to Amylin under the In-License
Agreements);

 

(ii) as the licensee or sublicensee of certain Amylin Technology under the
In-License Agreements, Amylin has the right, with respect to such licenses or
sublicenses, to enter into the covenants and agreements provided in this
Agreement to enable Takeda to exercise the rights granted under Article 7 in
accordance with the terms and conditions of this Agreement;

 

11.2.8              To Amylin’s Knowledge, it has made available to Takeda the
Amylin Patents and all written information in Amylin’s possession or Control,
which is reasonably necessary to Develop or Commercialize the Amylin Licensed
Compounds or Products in the Field in the Territory as contemplated by this
Agreement.

 

11.2.9              Amylin has not withheld any information in Amylin’s
possession or Control, which failure to disclose to Takeda would have a material
adverse effect on Takeda’s ability to Develop, Commercialize, or manufacture the
Amylin Licensed Compounds or Products in the Field in the Territory as
contemplated by this Agreement;

 

11.2.10       Amylin has specifically provided Takeda with the opportunity to
review the following:

 

(a)                                  all non-clinical safety data regarding the
Amylin Licensed Compounds that is in Amylin’s possession or Control;

 

(b)                                 any and all human subject safety data
(Life-threatening adverse drug experience, Serious adverse drug experience,
Unexpected adverse drug experience, Adverse Event, Serious Adverse Event,
Adverse Drug Reaction, Serious Adverse Drug Reaction,

 

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Unexpected Adverse Drug Reaction, as defined in 21 CFR 312 and/or ICH Guidance
(ICH-E6)) that is in Amylin’s possession or Control regarding the Amylin
Licensed Compounds set forth in Section 1.8(iii) and (iv);

 

(c)                                  with respect to the Amylin Licensed
Compound set forth in Section 1.8(i), any and all human subject safety data
(Life-threatening adverse drug experience, Serious adverse drug experience,
Unexpected adverse drug experience, Adverse Event, Serious Adverse Event,
Adverse Drug Reaction, Serious Adverse Drug Reaction, Unexpected Adverse Drug
Reaction, as defined in 21 CFR 312 and/or ICH Guidance (ICH-E6)) that is in
Amylin’s possession or Control and: (i) was submitted to the FDA in connection
with the regulatory approval, and maintenance of the regulatory approval, of
Symlin (pramlintide acetate) injection (including periodic safety update
reports); or (ii) derived from clinical trials studying pramlintide in obese
human subjects; and

 

(d)                                 with respect to the Amylin Licensed Compound
set forth in Section 1.8(ii), any and all human subject safety data
(Life-threatening adverse drug experience, Serious adverse drug experience,
Unexpected adverse drug experience, Adverse Event, Serious Adverse Event,
Adverse Drug Reaction, Serious Adverse Drug Reaction, Unexpected Adverse Drug
Reaction, as defined in 21 CFR 312 and/or ICH Guidance (ICH-E6)) that is in
Amylin’s possession or Control and: (i) was derived pursuant to clinical trials
conducted by Amgen or Amylin in obese and/or diabetic human subjects; and
(ii) was provided to the FDA pursuant to an IND;

 

11.2.11       Neither Amylin nor its Affiliates are aware of any safety,
efficacy, or regulatory issues, other than the information that has previously
been made available to Takeda in writing (including through electronic access),
that would preclude Takeda or Amylin from researching, Developing,
manufacturing, marketing, using, selling, offering for sale, importing,
exporting or otherwise Commercializing the Amylin Licensed Compounds or Products
in the Field in the Territory in compliance with Applicable Laws;

 

11.2.12       Amylin, its contractors and its consultants have conducted all
research and development, including non-clinical studies and Clinical Trials of
Amylin Licensed Compounds and/or Products and all manufacturing of Amylin
Licensed Compounds and/or Products in accordance with: (i) all material
provisions of Applicable Laws; (ii) the known or published standards of the FDA
or other applicable regulatory agencies in the Territory; (iii) the prevailing
scientific standards applicable to the conduct of such studies and activities in
Territory; and (iv) applicable Regulatory Materials, except in each of
subsections (i), (ii), (iii) and (iv) where the failure to do so would not have
a material adverse effect on the Development, manufacturing and/or
Commercialization of the Amylin Licensed Compounds or Products in the Field in
the Territory as contemplated by this Agreement;

 

11.2.13       Amylin has conducted audits and/or assessments of its contract
manufacturer organizations and contract research organizations , which
organizations are or have been involved in activities with respect to Amylin
Licensed Compounds or Products in accordance with the prevailing pharmaceutical
industry standards, and, to Amylin’s Knowledge there are no circumstances that
would have a material adverse effect on the Development, manufacturing and/or
Commercialization of the Amylin Licensed Compounds or Products in the Field in
the Territory as contemplated by this Agreement;

 

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11.2.14       Neither Amylin nor any officer, employee or agent of Amylin has
knowingly made an untrue statement of a material fact to any Regulatory
Authority in the Territory with respect to the Amylin Licensed Compounds and/or
Products or knowingly failed to disclose a material fact required to be
disclosed to any Regulatory Authority in the Territory with respect to the
Amylin Licensed Compounds and/or Products; and

 

11.2.15       None of the United States Government, any agency of the United
States Government, any foreign government, or any agency of a foreign government
has provided funding or support for any work performed in the conception or
reduction to practice of any Amylin Licensed Compound listed in Sections 1.8(i),
(iii) and (iv), or since February 7, 2006 with respect to the Amylin Licensed
Compound listed in Section 1.8(ii).  Other than possible funding provided to
Rockefeller by the United States government or an agency of the United States
government, to Amylin’s Knowledge, there has been no funding or support provided
by any other agency of the United States Government, any foreign government, or
any agency of a foreign government for any work performed in the conception or
reduction to practice of any Amylin Licensed Compound listed in Section 1.8(ii).

 

11.3                        Amylin Covenants.  Amylin covenants that throughout
the Term of the Agreement:

 

11.3.1              Amylin shall maintain in good standing in all material
respects the In-License Agreements, and it shall use Commercially Reasonable
Efforts to maintain in good standing in all material respects its other
agreements with Third Parties referenced in Section 11.2.6 that are necessary
for either Party to exercise its rights or perform its obligations under this
Agreement (provided that Amylin shall have no responsibility with respect to any
action or omission by Takeda or its Affiliates or sublicensees that may cause
any In-License Agreement or other agreement referenced in Section 11.2.6 not to
be maintained in good standing in any material respect);

 

11.3.2              Except as provided in Section 11.3.3, Amylin shall not amend
any term or condition of any In-License Agreement without the prior written
consent of Takeda, such consent not to be unreasonably withheld, delayed or
conditioned;

 

11.3.3              Amylin shall not amend any term or condition of the Psylin
Agreement or the Pacira Agreement in any manner that would adversely affect the
rights granted to Takeda under this Agreement without the prior written consent
of Takeda, such consent not to be unreasonably withheld or delayed; provided,
further, in the event that an analog of an Amylin Licensed Compound or an Analog
of an Amylin Licensed Compound is added as an Amylin Licensed Compound pursuant
to Section 3.3 or has become part of the Development Plan pursuant to
Section 3.5.2, and to the extent that such Amylin Licensed Compound has not
previously been [***], Amylin agrees to promptly designate such analog of an
Amylin Licensed Compound or Analog of an Amylin Licensed Compound as [***]; and

 

11.3.4              Amylin shall assist Takeda in obtaining waiver letters from
the National Institute of Health, and any other Person, as necessary to
manufacture Licensed Compounds or Products outside the United States.

 

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11.3.5              As will be provided in the pharmacovigilence agreement to be
entered into between the Parties pursuant to Section 4.4, upon Takeda’s request,
Amylin shall provide Takeda with access to any human subject safety data
(Life-threatening adverse drug experience, Serious adverse drug experience,
Unexpected adverse drug experience, Adverse Event, Serious Adverse Event,
Adverse Drug Reaction, Serious Adverse Drug Reaction, Unexpected Adverse Drug
Reaction, as defined in 21 CFR 312 and/or ICH Guidance (ICH-E6)) that is in
Amylin’s possession or Control as of the Effective Date, or that comes into
Amylin’s possession or Control during the Term of the Agreement, regarding the
Amylin Licensed Compounds set forth in Section 1.8(i), (ii), (iii) and (iv).

 

11.3.6              Upon Takeda’s request, Amylin shall make available to Takeda
Amylin Patents and any written information in Amylin’s possession or Control,
which is reasonably necessary to Develop or Commercialize the Amylin Licensed
Compounds or Products in the Field in the Territory as contemplated by this
Agreement.

 

11.4                        Mutual Covenants.  Each Party covenants that
throughout the Term of the Agreement:

 

11.4.1              Each Party shall, at all times, comply in all material
respects with all Applicable Laws including, but not limited to, the United
States Foreign Corrupt Practices Act;

 

11.4.2              If during the Term, a Party: (i) becomes debarred or
disqualified; or (ii) receives notice of an action or threat of an action with
respect to debarment or disqualification, such Party shall immediately notify
the other Party thereof in writing; and

 

11.4.3              All of such Party’s employees or contractors acting on its
behalf pursuant to this Agreement will be obligated under a binding written
agreement to assign to such Party or its designee all Inventions.

 

11.5        Takeda Acknowledgment. TAKEDA HEREBY ACKNOWLEDGES THAT IT HAS
EXPERIENCE IN THE OPERATION OF PHARMACEUTICAL DEVELOPMENT, MANUFACTURING,
DISTRIBUTION AND SALES, HAS INDEPENDENTLY EVALUATED AND CONDUCTED DUE DILIGENCE
WITH RESPECT TO THE AMYLIN LICENSED COMPOUNDS, INTELLECTUAL PROPERTY RIGHTS AND
THE INFORMATION PROVIDED OR MADE AVAILABLE BY AMYLIN AS DESCRIBED IN
SECTIONS 11.2.8 AND 11.2.10, AND HAS BEEN REPRESENTED BY, AND HAD THE ASSISTANCE
OF, COUNSEL, INCLUDING INTELLECTUAL PROPERTY COUNSEL, IN THE CONDUCT OF SUCH DUE
DILIGENCE, THE PREPARATION AND NEGOTIATION OF THIS AGREEMENT AND THE
CONSUMMATION OF THE TRANSACTIONS CONTEMPLATED HEREBY.  THE FOREGOING
ACKNOWLEDGEMENTS SHALL NOT AFFECT OR DIMINISH IN ANY WAY ANY OF THE
REPRESENTATIONS, WARRANTIES, COVENANTS, INDEMNIFICATIONS OR AGREEMENTS OF AMYLIN
CONTAINED IN THIS AGREEMENT.

 

11.6                        Disclaimer.  Except as expressly set forth in this
Agreement, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH
PARTY HEREUNDER ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY

 

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DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR
ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICE, IN ALL CASES WITH
RESPECT THERETO.  Without limiting the generality of the foregoing, each Party
expressly does not warrant: (i) the success of any study, test or Clinical Trial
conducted hereunder; or (ii) the safety or usefulness for any purpose of the
technology it provides hereunder.

 

12.                               INTELLECTUAL PROPERTY

 

12.1                        Ownership of Inventions. Inventorship of all
Inventions shall be determined in accordance with the rules of inventorship
under United States patent laws.  As between the Parties, ownership of
Inventions shall be as set forth in this Section 12.1.

 

12.1.1              Compound Related Inventions.  To the extent an Invention may
be practiced on: (i) Amylin Licensed Compounds and/or Option Compounds and/or
any analogs or derivatives thereof; or (ii) Excluded Products, Amylin shall own
such Invention (the “Amylin Compound Related Inventions”), and all Patents to
the extent such Patents claim such Amylin Compound Related Inventions.  To the
extent an Invention may be practiced on Takeda Y-family Agonists or other Takeda
Nominated Compounds, Takeda shall own such Invention (the “Takeda Compound
Related Inventions”) and all Patents to the extents such Patents claim such
Takeda Compound Related Inventions.  As an example, if Takeda invents a new
pharmaceutical formulation which may contain as a clinically active ingredient
Pramlintide, Compound X, Compound Y or Compound Z (and Compounds X, Y and Z are
not Amylin Licensed Compounds, Option Compounds or Excluded Products) Amylin
shall own the Invention of the formulation containing Pramlintide as well as any
corresponding patent rights, and Takeda shall own the Invention of the
formulation containing Compound X, Y or Z, as well as any corresponding patent
rights.

 

12.1.2              Takeda Inventions.  Takeda shall solely own all Inventions
other than Amylin Compound Related Inventions that are made, conceived or
reduced to practice solely by one or more employees or contractors of Takeda or
its Affiliate and all Patents that claim such Inventions.

 

12.1.3              Amylin Inventions.  Amylin shall solely own all Inventions
other than Takeda Compound Related Inventions that are made, conceived or
reduced to practice solely by one or more employees or contractors of Amylin or
its Affiliate and all Patents that claim such Inventions.

 

12.1.4              Joint Inventions.  Amylin and Takeda shall jointly own all
Inventions other than Amylin Compound Related Inventions and Takeda Compound
Related Inventions made, conceived or reduced to practice jointly by one or more
employees or contractors of Amylin or its Affiliate and one or more employees or
contractors of Takeda or its Affiliate (the “Joint Inventions”) and all Patents
that claim Joint Inventions (the “Joint Patents”), and each Party shall have an
undivided ownership interest in such Joint Inventions and Joint Patents.

 

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12.2                        Joint Obesity Patent Committee.  Amylin and Takeda
will establish a committee (the “JOPC”) to resolve any issues regarding
Inventorship or ownership of Inventions pursuant to the provisions of
Section 12.1.  The JOPC shall be composed of one patent counsel appointed by
Amylin and one patent counsel appointed by Takeda.  Amylin and Takeda may each
replace its JOPC representative at any time, upon written notice to the other
Party.  Each member of the JOPC shall have one vote in connection with any
matter to be determined by the JOPC.  All decisions of the JOPC shall be
unanimous and shall be made in accordance with the provisions of this
Section 12.1.  In the event that the members of the JOPC cannot reach a
unanimous decision the dispute shall be resolved in accordance with Article 15.

 

12.3                        Patent Prosecution and Maintenance. Takeda Patents. 
Takeda shall have the sole right to control and manage the preparation, filing,
prosecution and maintenance of all Takeda Patents (including the right to
conduct any interferences, oppositions, or reexaminations thereon and to request
any reissues or patent term extensions thereof), at Takeda’s sole expense. 
Takeda shall keep Amylin informed of progress with regard to the preparation,
filing, prosecution and maintenance of Takeda Patents in the Territory in a
timely manner through the JOPC. In the event that Takeda desires to abandon or
cease prosecution or maintenance of any Takeda Patent, Takeda shall provide
reasonable prior written notice to Amylin of such intention not to file or to
abandon or decline responsibility (which notice shall, in any event, be given no
later than [***] prior to the next deadline for any action that may be taken
with respect to such Takeda Patent with the applicable patent office), and
Takeda shall permit Amylin, at Amylin’s sole discretion, to continue prosecution
and/or maintenance of such Takeda Patent on Takeda’s behalf and at Amylin’s own
expense.

 

12.3.1              Amylin Patents.  Amylin (or its licensor with respect to
Amylin Patents licensed under the In-License Agreements) shall have the sole
right to control and manage the preparation, filing, prosecution and maintenance
of all Amylin Patents (including the right to conduct any interferences,
oppositions, or reexaminations thereon and to request any reissues or patent
term extensions thereof), at Amylin’s sole expense, except as expressly provided
in this Section 12.3.1 and subject to its right to do so with respect to Amylin
Patents licensed under the In-License Agreements.  Amylin shall keep Takeda
informed of progress with regard to the preparation, filing, prosecution and
maintenance of Amylin Patents in the Territory in a timely manner through the
JOPC.  Amylin will consider in good faith the requests and suggestions of Takeda
with respect to strategies for filing, prosecuting and maintaining Amylin
Patents in the Territory subject to its right to do so with respect to Amylin
Patents licensed under the In-License Agreements.  In the event that Amylin
desires to abandon or cease prosecution or maintenance of any Amylin Patent,
Amylin shall provide reasonable prior written notice to Takeda of such intention
not to file or to abandon or decline responsibility (which notice shall, in any
event, be given no later than [***] prior to the next deadline for any action
that may be taken with respect to such Amylin Patent with the applicable patent
office), and Amylin shall permit Takeda, at Takeda’s sole discretion, to
continue prosecution and/or maintenance of such Amylin Patent on Amylin’s behalf
and at Takeda’s own expense, subject to Amylin’s right to do so with respect to
Amylin Patents licensed under the In-License Agreements.

 

12.3.2              Joint Patents.  Takeda and Amylin shall discuss and evaluate
Joint Inventions and confer with each other regarding the advisability of filing
patent applications covering Joint Inventions and, if either Party requests that
a patent application be filed covering a

 

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Joint Invention, the other Party shall not unreasonably withhold its consent to
such filing.  The JOPC shall determine whether Amylin or Takeda shall have the
first right to control and manage (the “Filing Party”) the preparation, filing,
prosecution and maintenance of all Joint Patents (including the right to conduct
any interferences, oppositions, or reexaminations thereon and to request any
reissues or patent term extensions thereof), and an appropriate allocation of
expenses related thereto, using a mutually acceptable and independent patent
counsel.  The Filing Party shall keep the other Party informed of progress with
regard to the preparation, filing, prosecution and maintenance of Joint Patents
in the Territory in a timely manner through the JOPC, shall give the other Party
an opportunity to review the text of any patent application within the Joint
Patents before filing, and shall consider in good faith the requests and
suggestions of the other Party with respect to strategies for filing,
prosecuting and maintaining Joint Patents in the Territory.  In the event that
the Filing Party desires not to file or to abandon or cease prosecution or
maintenance of any Joint Patent, the Filing Party shall provide reasonable prior
written notice to the other Party of such intention not to file or to abandon or
decline responsibility (which notice shall, in any event, be given no later than
[***] prior to the next deadline for any action that may be taken with respect
to such Joint Patent with the applicable patent office), and the Filing Party
shall permit the other Party, at the other Party’s sole discretion, to file for
or continue prosecution and/or maintenance of such Joint Patent at the other
Party’s own expense, in which event the Filing Party shall assign all of its
right, title and interest in such Joint Patent to the other Party and such Joint
Patent shall thereafter be considered a Takeda Patent, or Amylin Patent, as the
case may be.

 

12.3.3              Cooperation of the Parties.  Each Party agrees to cooperate
fully in the preparation, filing, prosecution and maintenance of Takeda Patents,
Amylin Patents and Joint Patents under this Agreement.  Such cooperation
includes, but is not limited to:  (i) executing all papers and instruments, or
requiring its employees or contractors, to execute such papers and instruments,
so as to effectuate the ownership of Inventions set forth in Section 12.1, and
Patents claiming or disclosing such Inventions, and to enable the other Party to
apply for and to prosecute patent applications in any country as permitted by
this Agreement; and (ii) promptly informing the other Party of any matters
coming to such Party’s attention that may affect the preparation, filing,
prosecution or maintenance of any such patent applications.

 

12.3.4              Patent Term Extensions.  The JOPC will discuss and recommend
for which, if any, of the Amylin Patents, Joint Patents and Takeda Patents the
Parties should seek Patent term extensions in the Territory.  Amylin, in the
case of the Amylin Patents and Joint Patents, and Takeda in the case of the
Takeda Patents, shall have the final decision-making authority with respect to
applying for any such Patent term extensions, and will act with reasonable
promptness in light of the Development stage of Products to apply for any such
Patent term extensions, where it so elects; provided, however, if in a
particular country or jurisdiction in the Territory, only one such Patent can
obtain a patent term extension, then the Parties will consult in good faith to
determine which such Patent should be the subject of efforts to obtain a Patent
term extension, and in any event, Amylin’s decision, in the case of the Amylin
Patents, and Takeda’s decision, in the case of the Takeda Patents and the Joint
Patents, will control in the case of any disagreement.  The Party that does not
apply for an extension hereunder will cooperate fully with the other Party in
making such filings or taking such actions, including, but not limited to,
making available all required regulatory data and information and executing any
required authorizations to apply for such Patent term extension.  The Party
seeking

 

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a Patent term extension shall be obligated to pay the costs and expenses
incurred by each Party in connection with such activity.

 

12.3.5              Orange Book Listing; Compendial Listing.   Upon request of
Takeda, Amylin shall cooperate with Takeda to: (i) file appropriate information
with the FDA in the United States listing any Amylin Patents in the Orange Book;
and (ii) with respect to other countries in the Territory, file appropriate
information with the applicable Regulatory Authority listing any Amylin Patents
in the Patent listing source in such country in the Territory that is equivalent
to the Orange Book, if any.

 

12.4                        Infringement by Third Parties.  Amylin and Takeda
shall promptly notify the other in writing of any alleged or threatened
infringement of any Takeda Patent, Amylin Patent or Joint Patent of which they
become aware.

 

12.4.1              Takeda Patents.  Takeda shall have the sole right to bring
and control any action or proceeding with respect to alleged or threatened
infringement of any Takeda Patent, at its own expense and by counsel of its own
choice.

 

12.4.2              Amylin Patents.  Except to the extent that an alleged or
threatened infringement of an Amylin Patent relates to an Excluded Product,
Takeda shall have the first right to bring and control any action or proceeding
with respect to alleged or threatened infringement of any Amylin Patent (to the
extent Amylin may grant to Takeda such rights with respect to Amylin Patents
licensed under the In-License Agreements), at its own expense, to the extent
that any such infringement could reasonably be expected to have a material
adverse effect on any Product being developed or commercialized for use in the
Field in the Territory (a “Material Activity”), and Amylin shall have the right,
at its own expense, to be represented in any such action by counsel of its own
choice.  Takeda and its counsel will reasonably cooperate with Amylin and its
counsel in strategizing with respect to, and preparing and presenting, any such
action.  If Takeda fails to bring any such action within: (i) [***] following
the notice of alleged infringement; or (ii) [***] before the time limit, if any,
set forth in the appropriate laws and regulations for the filing of such action,
whichever comes first, then Amylin shall have the right to bring and control any
such action, at its own expense and by counsel of its own choice, and Takeda
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice.  Amylin (or its licensor with respect to Amylin
Patents licensed under the In-License Agreements) shall have the sole right to
bring and control any action or proceeding with respect to alleged or threatened
infringement of any Amylin Patent that is not a Material Activity.

 

12.4.3              Joint Patents.  Takeda shall have the first right to bring
and control any action or proceeding with respect to alleged or threatened
infringement of any Joint Patent, at its own expense and by counsel of its own
choice, and Amylin shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice.  If Takeda fails to bring any
such action or proceeding within (a) [***] following the notice of alleged
infringement, or (b) [***] before the time limit, if any, set forth in the
appropriate laws and regulations for the filing of such actions, whichever comes
first, then Amylin shall have the right to bring and control any such action, at
its own expense and by counsel of its own choice,

 

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and Takeda shall have the right, at its own expense, to be represented in any
such action by counsel of its own choice.

 

12.4.4              Cooperation; Award.  In the event a Party brings an
infringement action in accordance with this Section 12.4, the other Party shall
cooperate fully, including, if required to bring such action, the furnishing of
a power of attorney or being named as a Party.  Neither Party shall enter into
any settlement or compromise of any action under this Section 12.4 which would
in any manner alter, diminish, or be in derogation of the other Party’s rights
under this Agreement without the prior written consent of such other Party,
which shall not be unreasonably withheld.  Except as otherwise agreed to in
writing by the Parties, any recovery realized as a result of such action shall
be used first to reimburse the documented out-of-pocket legal expenses of the
Parties relating to such action, and any remainder shall be retained by the
Party that brought and controlled such action for purposes of this Agreement,
except that any such remainder retained by Takeda shall be treated as Net Sales
for purposes of this Agreement.

 

12.5                        Infringement of Third Party Rights.  Each Party
shall promptly notify the other Party in writing of any allegation by a Third
Party that the activity of either Party pursuant to this Agreement infringes or
may infringe the intellectual property rights of such Third Party.  Amylin shall
have the sole right to control any defense of any such claim involving alleged
infringement of Third Party rights by Amylin’s activities, at its own expense
and by counsel of its own choice, and Takeda shall have the right, at its own
expense, to be represented in any such action by counsel of its own choice. 
Takeda shall have the sole right to control any defense of any such claim
involving alleged infringement of Third Party rights by Takeda’s activities, at
its own expense and by counsel of its own choice, and Amylin shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice.  Neither Party shall enter into any settlement or compromise of
any action under this Section 12.5 which would in any manner alter, diminish, or
be in derogation of the other Party’s rights under this Agreement without the
prior written consent of such other Party, which shall not be unreasonably
withheld. In the event that it is determined by any court of competent
jurisdiction that the research, Development, manufacture, distribution, use,
sale, import, export or other Commercialization of a Licensed Compound or
Product, conducted in accordance with the terms and conditions of this
Agreement, infringes, or the OSC determines that such activities are likely to
infringe, any patent, copyright, trademark, data exclusivity right or trade
secret right arising under Applicable Laws of any Third Party, the Parties shall
use Commercially Reasonable Efforts to: (i) procure a license from such Third
Party authorizing Amylin and Takeda to continue to conduct such activities; or
(ii) modify such activities with Takeda’s prior written consent, so as to render
it non-infringing. If a license is obtained from such Third Party the cost of
such license shall be allocated between the Parties in accordance with
Section 8.5, provided the Parties have agreed to undertake such a cost. In the
event that the OSC decides that neither of the foregoing alternatives is
reasonably available or commercially feasible, the Parties may mutually agree to
terminate this Agreement for the Licensed Compound or Product affected in
accordance with Section 13.2.5.

 

12.6                        Patent Term Restoration.  At the request of the
Party owning any Patents subject to this Agreement, the Parties hereto will
cooperate with each other in obtaining patent term restoration, extensions
and/or any other extensions of such Patents as available under Applicable Laws.

 

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12.7                        Patent Marking.  Takeda shall mark all Products
made, used or sold under the terms of this Agreement, or their containers, in
accordance with all Applicable Laws relating to patent marking.

 

12.8                        Certification.  Takeda and Amylin each will
immediately give notice to the other of any certification of which they become
aware filed under the U.S. Drug Price Competition and Patent Term Restoration
Act of 1984, as amended, arising from the filing of an application for the
regulatory approval of a Generic Product claiming that Patents covering any
Product are invalid or that infringement will not arise from the manufacture,
use or sale of any Product in the Field in the Territory by a Third Party.  Any
action based on such a certification shall be brought and controlled as provided
in Section 12.4.

 

12.9                        Product Trademarks.  Takeda shall have sole control
over all matters relating to the use of, and shall own, all trademarks used in
the sale of Products in the Field in the Territory, including the selection,
filing and enforcement thereof, but excluding Symlin® and other trademarks which
are proprietary to Amylin.

 

13.                               TERM; TERMINATION

 

13.1                        Term.  The term of this Agreement (the “Term”) shall
commence on the Effective Date and continue in effect until the expiration of
all payment obligations under Article 8, unless earlier terminated as provided
in Section 13.2.

 

13.2                        Termination.  Each Party may terminate this
Agreement: (i) in its entirety; or (ii) on a Licensed Compound-by-Licensed
Compound, Product-by-Product and country-by-country basis (a “Partial
Termination”), in accordance with the terms and conditions set forth in this
Section 13.2.

 

13.2.1              Termination for Cause.

 

(a)                                  Bankruptcy.  A Party may terminate this
Agreement in its entirety upon written notice to the other Party upon or after
the time that such other Party makes a general assignment for the benefit of
creditors, files an insolvency petition in bankruptcy, petitions for or
acquiesces in the appointment of any receiver, trustee or similar officer to
liquidate or conserve its business or any substantial part of its assets,
commences under the laws of any jurisdiction any proceeding involving its
insolvency, bankruptcy, reorganization, adjustment of debt, dissolution,
liquidation or any other similar proceeding for the release of financially
distressed debtors or becomes a party to any proceeding or action of the type
described above and such proceeding or action remains un-dismissed or un-stayed
for a period of more than [***].

 

(b)                                 Payment Default.  A Party may terminate this
Agreement in its entirety upon written notice to the other Party upon or after
the breach of any payment obligation under this Agreement if the breaching Party
has not cured such breach within the [***] period following receipt of written
notice of termination by the non-breaching Party.

 

(c)                                  Material Breach.  A Party may terminate
this Agreement with respect to the affected Licensed Compound and/or Product,
and the affected country, upon

 

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written notice to the other Party upon or after the breach of any material
provision of this Agreement by such other Party (except for any payment breach
or any breach of Commercially Reasonable Efforts, for which the right to
terminate shall be exclusively governed by Section 13.2.1(b) and 13.2.1(d),
respectively) if the breaching Party has not cured such breach within the [***]
period following receipt by the breaching Party of written notice of termination
from the notifying Party.  Notwithstanding the foregoing, in the event such
breach is not reasonably capable of being cured within the [***] cure period by
the breaching Party and such breaching Party is making a good faith effort to
cure such breach, the notifying Party may not terminate this Agreement with
respect to the affected Licensed Compound and/or Product, and the affected
country; provided, however, that the notifying Party may terminate this
Agreement with respect to the affected Licensed Compound and/or Product, and the
affected country, if such breach is not cured within [***] of receipt by the
breaching Party of such original notice of termination. For the avoidance of
doubt, the Parties recognize that certain material breaches, other than a breach
of Commercially Reasonable Efforts for which the right to terminate shall be
exclusively governed by Section 13.2.1(d), may be of such a significant nature
as to warrant termination of this Agreement in its entirety including, by way of
example, certain material breaches relating to: (i) the use of Confidential
Information; (ii) intellectual property rights; (iii) violations of Applicable
Laws; or (iv) fraudulent activities related to the exercise of rights or
performance of obligations under the Agreement.

 

(d)                                 Breach of Commercially Reasonable Efforts.
In the event that a Party provides written notice of termination for the breach
by the other Party of any obligation to use Commercially Reasonable Efforts with
regard to Development, manufacturing or Commercialization of Products in the
Field in the Territory, such matter shall be submitted to the OSC for resolution
pursuant to Section 2.1.4.  If the OSC is not able to resolve such matter by
unanimous vote, the dispute shall be resolved in accordance with Article 15;
provided, however, if it is determined that a Party is in breach of Commercially
Reasonable Efforts pursuant to Section 15.2 or 15.3, the notifying Party may
terminate this Agreement with respect to the affected Licensed Compound and/or
Product, and the affected country, upon providing written notice to the other
Party if the breaching Party has not cured such breach within [***] following
resolution of the dispute pursuant to Article 15.  Notwithstanding the
foregoing, in the event such a breach is not reasonably capable of being cured
within the [***] cure period by the breaching Party, and such breaching Party is
making a good faith effort to cure such breach, the notifying Party may not
terminate this Agreement; provided, however, that the notifying Party may
terminate this Agreement with respect to the affected Licensed Compound and/or
Product, and the affected country, pursuant to this Section 13.2.1(d), if such
breach is not cured within [***] following resolution of the dispute pursuant to
Article 15.  For the avoidance of doubt, nothing contained in this
Section 13.2.1(d) shall permit at any time a non-breaching Party to terminate
this Agreement in its entirety, or to terminate this Agreement with respect to a
non-affected Licensed Compound and/or Product, or a non-affected country.

 

The right of either Party to terminate this Agreement as provided in this
Section 13.2.1 shall not be affected in any way by its waiver of, or failure to
take action with respect to, any previous breach.

 

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13.2.2     Termination for Patent Challenge.  Either Party may terminate this
Agreement by written notice effective upon receipt if the other Party, or any of
the other Party’s Affiliates or sublicensees, directly or indirectly through
assistance granted to a Third Party, commences any interference or opposition
proceeding, challenges the validity or enforceability of, or opposes any
extension of or the grant of a supplementary protection certificate with respect
to, in the case of Takeda or any of its Affiliates or sublicensees, any Amylin
Patent, and in the case of Amylin or any of its Affiliates or sublicensees, any
Takeda Patent (each such action, a “Patent Challenge”).  Takeda will include
provisions in all agreements granting sublicenses of Amylin Patents providing
that, if the sublicensee undertakes a Patent Challenge with respect to any
Amylin Patent under which the sublicensee is sublicensed, Takeda will terminate
such sublicense agreement.

 

13.2.3     Termination for Safety Reasons.

 

(a)           Either Party shall have the right to terminate this Agreement with
respect to any Licensed Compound or Product in the Territory, without liability
for any compensation or other payment obligation to the other Party due to such
termination except as expressly specified in this Agreement, by providing the
other Party with at least [***] prior written notice of termination, if, at any
time, the OSC determines that such Licensed Compound or Product, caused or is
likely to cause a fatal, life-threatening or other serious adverse safety event
that is reasonably expected, based upon then available data, to preclude
obtaining Regulatory Approval for such Licensed Compound or Product, or, if
Regulatory Approval of such Product has already been obtained, to preclude
continued marketing of such Product; provided, further, if the OSC does not
agree on the issue, either Party may terminate this Agreement with respect to
such Licensed Compound or Product if: (i) each Party’s Chief Executive Officer
(or such delegate of either Chief Executive Officer who shall have appropriate
decision making authority regarding such dispute) meets in person or by
telephone, within [***]  after receiving written notice of the other Party’s
intent to terminate hereunder, to resolve the dispute in good faith; and
(ii) they are unable to resolve the dispute.  For the avoidance of doubt, in the
event of a termination for safety reasons hereunder, the terminating Party may
immediately suspend Development and/or Commercialization activities relating to
the terminated Licensed Compound or Product.

 

(b)           Notwithstanding anything to the contrary in this Agreement, with
respect to termination pursuant to Section 13.2.3(a) above, Takeda shall: (i) be
relieved from making any development milestone payments to Amylin under
Section 8.2.1 regarding such Licensed Compound or Product to the extent a
development milestone trigger event occurs after either Party sends the other
Party a notice of termination hereunder; and (ii) pay only those commercial and
sales-based milestone payments to Amylin under Section 8.2.1 regarding such
Licensed Compound or Product to the extent a commercial or sales-based milestone
trigger event occurs within [***] after notice of termination.

 

13.2.4     Commercial Viability.

 

(a)           At any time, Takeda may terminate this Agreement with respect to
any Licensed Compound or Product and any country in the Territory, if it
determines that it cannot continue the Agreement on a profitable and
commercially viable basis, and upon: (i)

 

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[***] consultation with the other Party and after providing [***] prior written
notice at any time prior to launch of the Product, or (ii) [***] consultation
with the other Party and after providing [***]  prior written notice at any time
after launch of the Product. For the avoidance of doubt, such [***] consultation
periods are intended to fall within such [***] and [***] notice periods.

 

(b)           For the avoidance of doubt, the determination of profitability and
commercial viability under this Section 13.2.4 shall be made on the basis of
Commercially Reasonable Efforts and taking into account financial projections
suitable to support Commercialization of the Licensed Compound or Product.

 

(c)           Notwithstanding anything to the contrary in this Agreement, with
respect to termination pursuant to (a) and (b) above, Takeda shall be relieved
from making any development milestone payments to Amylin as to such Licensed
Compound or Product under Section 8.2.1 to the extent a development milestone
trigger event occurs after either Party sends such notice of termination
hereunder.

 

13.2.5     No Third Party License.  The Parties may terminate this Agreement
with respect to any Licensed Compound or Product and any country in the
Territory immediately upon mutual written agreement if a necessary Third Party
license is not obtained, all in accordance with Section 12.5.

 

13.3        Consequences of Termination

 

13.3.1     Termination of Rights and Obligations.  Upon expiration of this
Agreement or early termination of this Agreement under Section 13.2, all rights
and obligations of the Parties under this Agreement shall terminate, except as
provided in this Section 13.3. In case of Partial Termination of this Agreement
where termination is only with respect to one or more of the Licensed Compounds
or Products (the “Terminated Product”) in a particular country (the “Terminated
Country”), then, notwithstanding anything to the contrary contained in
Section 13.3, the consequences of termination described under this Section 13.3
shall only apply to the Terminated Product in the Terminated Country, and this
Agreement shall remain in full force and effect in accordance with its terms
with respect to all Licensed Compounds or Products other than the Terminated
Products, in all countries of the Territory other than the Terminated Countries.

 

13.3.2     Winding Down of Activities.  In the event there are any on-going
research, Development or Commercialization activities, the Parties shall
negotiate in good faith and adopt a plan to wind-down such activities in an
orderly fashion or, at the continuing Party’s election, promptly transition such
activities from the terminating Party to the continuing Party or its designee,
with due regard for patient safety and the rights of any subjects that are
participants in any Clinical Trials of Licensed Compounds or Products, and take
any actions it deems reasonably necessary or appropriate to avoid any human
health or safety problems and in compliance with all Applicable Laws.

 

13.3.3     Reversion of Rights to Amylin.  Except as otherwise set forth in
Section 13.3.3(e), upon termination of this Agreement by: (i) mutual agreement
of the Parties, including

 

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under Section 13.2.3(a) or 13.2.5; (ii) Takeda under Section 13.2.3(a) or
13.2.4; or (iii) Amylin under Section 13.2.1 or 13.2.2:

 

(a)           Takeda shall, and it hereby does, grant to Amylin an exclusive
(even as to Takeda) license, with the right to sublicense through multiple tiers
of sublicense, under the Takeda Technology and Takeda’s interest in the Joint
Inventions and Joint Patents (to the extent used at the time of termination), to
research, develop, make, have made, distribute, use, sell, have sold, offer for
sale, import and export Licensed Compounds and Products in the Territory,
subject in each case to compliance by Amylin with the surviving provisions of
this Agreement;

 

(b)           Takeda shall: (i) transfer to Amylin as soon as reasonably
practicable all Takeda Know-How as may be necessary to enable Amylin to practice
the license granted under Section 13.3.3(a); (ii) transfer and assign to Amylin
all of its right, title and interest in and to all INDs, Regulatory Approvals
and other Regulatory Materials with respect to such Licensed Compounds and
Products; (iii) if Takeda is responsible for manufacturing the Licensed
Compounds and Products pursuant to Article 6, Takeda shall transition to Amylin
upon Amylin’s request any arrangement with any contractor from which Takeda had
arranged to obtain supplies of Licensed Compounds or Products, to the extent
permitted under Takeda’s agreement with such contractor, or in the event that
such materials are manufactured by Takeda or its Affiliates then, upon request
by Amylin, Takeda shall continue to supply Amylin with such materials at a
commercially reasonable price and for a time period to be agreed by the Parties,
and, if requested, provide technical assistance (at Takeda’s reasonable cost)
reasonably necessary to assist Amylin in the start up of manufacturing of the
Licensed Compound and Product and obtaining Regulatory Approval thereof; and
(iv) take such other actions and execute such other instruments, assignments and
documents as may be necessary to effect the transfer of rights to such Licensed
Compounds or Products hereunder to Amylin;

 

(c)           Takeda shall, and hereby does, grant to Amylin a license, with the
right to further sublicense, to use the trademark registered by Takeda pursuant
to Section 12.9 with respect to any Licensed Compound or Product in the
Territory in exchange for paying to Takeda a royalty of [***] percent ([***] %)
of Net Sales of such Licensed Compound or Product in the Territory by Amylin and
its Affiliates and sublicensees (with the definition Net Sales and the
provisions of Article 9 applying to Amylin as if relevant references to Takeda
were instead references to Amylin in the case that Amylin owes such royalty to
Takeda), from the effective date of such termination until the expiration of the
last-to-expire of the Takeda Patents and Joint Patents claiming such Licensed
Compound or Product in the Territory, at which time such license shall become
fully paid, royalty-free, perpetual and irrevocable;

 

(d)           If, after termination of the Agreement pursuant to 13.2.5, Amylin
is able to obtain the necessary Third Party license to intellectual property
rights and thereafter commercializes the Licensed Compound or Product in the
Territory, Amylin shall pay Takeda a royalty of [***] percent ([***] %) on Net
Sales of such Product sold by Amylin, its Affiliate or a licensee;

 

(e)           If the Parties mutually agree to terminate the Agreement pursuant
to Section 13.2.3(a) or 13.2.5, then: (i) any and all rights in Amylin
Technology Controlled by

 

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Takeda shall be transferred, licensed to, or assigned, as applicable, from
Takeda to Amylin; and (ii) any and all rights in Takeda Technology Controlled by
Amylin shall be transferred, licensed to, or assigned, as applicable, from
Amylin to Takeda; and

 

(f)            In consideration for the license granted by Takeda to Amylin
under this Section 13.3.3, Amylin shall pay to Takeda royalties on Net Sales
derived from the sale of the following Products and equal to: (i) in the case of
termination by Takeda under Section 13.2.3(a) of a Product that contains only a
Takeda Y-family Agonist, [***] percent ([***] %) during the Initial Royalty
Term, [***] percent ([***] %) during the Secondary Royalty Term, and,
thereafter, such license shall be fully-paid, royalty-free, perpetual and
irrevocable; and (ii) in the case of termination by Takeda under
Section 13.2.3(a) of a Product that contains a Takeda Y-family Agonist and an
Amylin Licensed Compound, [***] percent ([***] %) during the Initial Royalty
Term, [***] percent ([***] %) during the Secondary Royalty Term, and,
thereafter, such license shall be fully-paid, royalty-free, perpetual and
irrevocable.  All royalties payable by Amylin to Takeda under this
Section 13.3.3(f) shall be paid on a [***] basis in accordance with the
provisions of Article 9 hereof.  Amylin shall be entitled to take a credit
against such royalties in an amount not to exceed any amounts payable under this
Agreement by Takeda to Amylin, which have accrued but remain outstanding as of
the date of termination, minus any amounts payable hereunder by Amylin to
Takeda, which have accrued but remain outstanding as of the date of termination.

 

13.3.4     Product Rights to Takeda.  Upon termination of this Agreement by:
(i) Amylin under Section 13.2.3(a); or (ii) Takeda under Section 13.2.1 or
13.2.2:

 

(a)           Amylin shall, and it hereby does, grant to Takeda an exclusive
(even as to Amylin) license, with the right to sublicense through multiple tiers
of sublicense, under the Amylin Technology and Amylin’s interest in the Joint
Inventions and Joint Patents, to research, develop, make, have made, distribute,
use, sell, have sold, offer for sale, import and export the Licensed Compounds
or Products in the Field in the Territory.

 

(b)           In consideration for the license granted by Amylin to Takeda under
this Section 13.3.4, Takeda shall pay to Amylin royalties on Net Sales derived
from the sale of the Products, equal to: (i) in the case of termination by
Amylin under Section 13.2.3(a), [***] percent ([***] %) during the Initial
Royalty Term, [***] percent ([***] %) during the Secondary Royalty Term, and,
thereafter, such license shall be fully-paid, royalty-free, perpetual and
irrevocable; and (ii) in the case of termination by Takeda under Section 13.2.1
or 13.2.2, [***] percent ([***] %) during the Initial Royalty Term, [***]
percent ([***] %) during the Secondary Royalty Term, and, thereafter, such
license shall be fully-paid, royalty-free, perpetual and irrevocable.  All
royalties payable by Takeda to Amylin under this Section 13.3.4(b) shall be paid
on a [***] basis in accordance with the provisions of Article 9 hereof.  Takeda
shall be entitled to take a credit against such royalties in an amount not to
exceed any amounts payable hereunder by Amylin to Takeda, which have accrued but
remain outstanding as of the date of termination, minus any amounts payable
hereunder by Takeda to Amylin, which have accrued but remain outstanding as of
the date of termination.

 

(c)           Amylin shall: (i) transfer to Takeda as soon as reasonably
practicable all Amylin Know How as may be necessary to enable Takeda to practice
the license

 

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granted under Section 13.3.4(a); (ii) transfer and assign to Amylin all of its
right, title and interest in and to the all INDs, Regulatory Approvals and other
Regulatory Materials with respect to such Licensed Compounds or Products;
(iii) if Amylin is responsible for manufacturing the Licensed Compounds or
Products pursuant to Article 6, Amylin shall transition to Takeda upon Takeda’s
request any arrangement with any contractor from which Amylin had arranged to
obtain supplies of Products, to the extent permitted under Amylin’s agreement
with such contractor, or in the event that such materials are manufactured by
Amylin or its Affiliate, then, upon request by Takeda, Amylin shall continue to
supply Takeda with such materials at a commercially reasonable price and for a
time period to be mutually agreed upon by the Parties, and, if necessary,
provide technical assistance (at Amylin’s reasonable cost) reasonably necessary
to assist Takeda in the start-up of manufacturing of the Licensed Compound or
Product and obtaining Regulatory Approval thereof, and (iv) take such other
actions and execute such other instruments, assignments and documents as may be
necessary to effect the transfer of rights to such Licensed Compounds or 
Products hereunder to Takeda.

 

13.3.5     Return of Confidential Information.  Upon expiration or termination
of this Agreement, except to the extent that the continuing Party retains a
license from the terminating Party under Sections 13.3.3 or 13.3.4, each Party
will promptly return all records and materials in its possession or control
containing or comprising the other Party’s Confidential Information.  Each Party
shall have the right to maintain one copy of such records in its legal
department files for archive purposes, provided that such copy is maintained in
accordance with the surviving confidentiality obligations of this Agreement.

 

13.3.6     Surviving Terms.  Expiration or termination of this Agreement for any
reason shall not relieve the Parties of any liability or obligation accruing
prior to such expiration or termination nor affect the survival of any provision
hereto to the extent it is expressly stated to survive such termination. In
addition, the rights and obligations of the Parties under the following
provisions of this Agreement shall survive expiration or termination of this
Agreement:  Sections 3.5.2(d) (last sentence), 3.7, 3.8, 7.5, 7.1.3, 9.4, 11.5,
11.6, 12.1, 13.3, 13.4, 13.5, and Articles 1, 10, 14, 15 and 16.

 

13.4        Damages; Relief.  Termination of this Agreement shall not preclude
either Party from claiming any other damages, compensation or relief that it may
be entitled to under this Agreement.

 

13.5        Exercise of Right to Terminate.  The use by either Party of a
termination right provided for under this Agreement shall not give rise to the
payment of damages or any other form of compensation or relief to the other
Party with respect thereto.

 

13.6        Bankruptcy Laws.  All rights and licenses granted under or pursuant
to this Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of Title 11 of the United States Code and other similar laws in
any jurisdiction outside the United States (collectively, the “Bankruptcy
Laws”), licenses of rights to be “intellectual property” as defined under the
Bankruptcy Laws.  If a case is commenced during the Term by or against a Party
under Bankruptcy Laws then, unless and until this Agreement is rejected as
provided in such Bankruptcy Laws, such Party (in any capacity, including
debtor-in-possession) and its successors and assigns (including a Title 11
trustee) shall perform all of the obligations provided in this

 

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Agreement to be performed by such Party.  If a case is commenced during the Term
by or against a Party under the Bankruptcy Laws, this Agreement is rejected as
provided in the Bankruptcy Laws, and the other Party elects to retain its rights
hereunder as provided in the Bankruptcy Laws, then the Party subject to such
case under the Bankruptcy Laws (in any capacity, including debtor-in-possession)
and its successors and assigns (including a Title 11 trustee), shall provide to
the other Party copies of all Information necessary for such other Party to
prosecute, maintain and enjoy its rights under the terms of this Agreement
promptly upon such other Party’s written request therefor.  All rights, powers
and remedies of the non-bankrupt Party as provided herein are in addition to and
not in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including the Bankruptcy Laws) in the
event of the commencement of a case by or against a Party under the Bankruptcy
Laws.  Additionally, in the event of any insolvency of Takeda or the entry by it
into any formal insolvency administration under Japanese law, it is the
intention of the Parties that this Agreement shall not terminate and shall
continue pursuant to the principles governing insolvency proceedings under
Japanese law.  In particular, it is the intention and understanding of the
Parties to this Agreement that the rights granted to the Parties under this
Section 13.6 are essential to the Parties’ respective businesses and the Parties
acknowledge that damages are not an adequate remedy.

 

14.          INDEMNIFICATION

 

14.1        Indemnification by Takeda.  Takeda hereby agrees to save, defend and
hold Amylin and its Affiliates, and each of their respective directors,
officers, employees, agents and representatives (each, an “Amylin Indemnitee”)
harmless from and against any and all claims, suits, actions, demands,
liabilities, expenses and/or loss, including reasonable legal expense and
attorneys’ fees (collectively, the “Losses”), to which any Amylin Indemnitee may
become subject as a result of any claim, demand, action or other proceeding by
any Third Party (each, a “Claim”) to the extent such Losses arise directly or
indirectly out of: (i) the practice by Takeda or its Affiliate or sublicensee of
any license granted to it under Article 7; (ii) the manufacture, use, handling,
storage, sale or other disposition of any Licensed Compound or Product by Takeda
or its Affiliate or sublicensee; (iii) failure by Takeda to obtain or maintain
rights under the Takeda Technology sufficient to grant Amylin the licenses set
forth in Article 7; (iv) the breach by Takeda of any warranty, representation,
covenant or agreement made by Takeda in this Agreement, or, if Amylin exercises
the Co-Commercialization Option, the Co-Commercialization Agreement; (v) the
negligence, gross negligence or willful misconduct (including to the extent such
negligence, gross negligence or willful misconduct gives rise to product
liability Claims under any legal theory) of Takeda or its Affiliate or
sublicensee, or any officer, director, employee, agent or representative
thereof; or (vi) any development or commercialization by Takeda or its Affiliate
or sublicensee of any Licensed Compound or Product following the termination of
this Agreement by Amylin pursuant to Section 13.2.3(a) with respect to such
Licensed Compound or Product; except, with respect to each of subsections
(i) through (vi) above, to the extent such Losses arise directly or indirectly
from the negligence, gross negligence or willful misconduct of any Amylin
Indemnitee or the breach by Amylin of any warranty, representation, covenant or
agreement made by Amylin in this Agreement.

 

14.2        Indemnification by Amylin.  Amylin hereby agrees to save, defend and
hold Takeda and its Affiliates and each of their respective directors, officers,
employees, agents and

 

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representatives (each, a “Takeda Indemnitee”) harmless from and against any and
all Losses to which any Takeda Indemnitee may become subject as a result of any
Claim to the extent such Losses arise directly or indirectly out of: (i) the
manufacture, use, handling, storage, sale or other disposition of any Licensed
Compound, Product or Excluded Product by Amylin or its Affiliate or licensee
(other than Takeda or its Affiliate or sublicensee); (ii) the practice by Amylin
or its Affiliate or licensee of any retained license right under Article 7 to
Develop or Commercialize any Licensed Compound or Product pursuant to the terms
of this Agreement, or, if Amylin exercises its Co-Commercialization Option, any
Co-Commercialization Agreement; (iii) failure by Amylin to obtain or maintain
rights under the Amylin Technology sufficient to grant Takeda the licenses set
forth in Article 7, including any breach or material amendment of an In-License
Agreement by Amylin or the other party to such agreement; (iv) the breach by
Amylin of any warranty, representation, covenant or agreement made by Amylin in
this Agreement, or, if Amylin exercises the Co-Commercialization Option, the
Co-Commercialization Agreement; (v) the negligence, gross negligence or willful
misconduct (including to the extent such negligence, gross negligence or willful
misconduct gives rise to product liability Claims under any legal theory) of
Amylin or its Affiliate or licensee (other than Takeda or its Affiliate or
sublicensee), or any officer, director, employee, agent or representative
thereof; or (vi) any development or commercialization by Amylin or its Affiliate
or licensee of any Licensed Compound or Product following the termination of
this Agreement by Takeda pursuant to Section 13.2.3(a) with respect to such
Licensed Compound or Product; except, with respect to each of subsections
(i) through (vi) above, to the extent such Losses arise directly or indirectly
from the negligence, gross negligence or willful misconduct of any Takeda
Indemnitee or the breach by Takeda of any warranty, representation, covenant or
agreement made by Takeda in this Agreement.

 

14.3        Indemnification Procedures.

 

14.3.1     Notice.  Promptly after an Amylin Indemnitee or a Takeda Indemnitee
(each, an “Indemnitee”) receives notice of a pending or threatened Claim, such
Indemnitee shall give written notice of the Claim to the Party from whom the
Indemnitee is entitled to receive indemnification pursuant to Sections 14.1 or
14.2, as applicable (the “Indemnifying Party”).  However, an Indemnitee’s delay
in providing or failure to provide such notice will not relieve the Indemnifying
Party of its indemnification obligations, except to the extent it can
demonstrate prejudice due to the delay or lack of notice.

 

14.3.2     Defense.  Upon receipt of notice under Section 14.3.1 from the
Indemnitee, the Indemnifying Party will have the duty to either compromise or
defend, at its own expense and by counsel (reasonably satisfactory to
Indemnitee), such Claim.  The Indemnifying Party will promptly (and in any event
not more than twenty (20) days after receipt of the Indemnitee’s original
notice) notify the Indemnitee in writing that it acknowledges its obligation to
indemnify the Indemnitee with respect to the Claim pursuant to this Article 14
and of its intention either to compromise or defend such Claim.  Once the
Indemnifying Party gives such notice to the Indemnitee, the Indemnifying Party
is not liable to the Indemnitee for the fees of other counsel or any other
expenses subsequently incurred by the Indemnitee in connection with such
defense, other than the Indemnitee’s reasonable costs of investigation and
cooperation.  However, the Indemnitee will have the right to employ separate
counsel and to control the defense of a Claim at its own expense.

 

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14.3.3     Cooperation.  The Indemnitee will cooperate fully with the
Indemnifying Party and its legal representatives in the investigation and
defense of any Claim.  The Indemnifying Party will keep the Indemnitee informed
on a reasonable and timely basis as to the status of such Claim (to the extent
the Indemnitee is not participating in the defense of such Claim) and conduct
the defense of such Claim in a prudent manner.

 

14.3.4     Settlement.  If an Indemnifying Party assumes the defense of a Claim,
no compromise or settlement of such Claim may be effected by the Indemnifying
Party without the Indemnitee’s written consent (which consent will not be
unreasonably withheld or delayed), unless: (i) there is no finding or admission
of any violation of law or any violation of the rights of any person and no
effect on any other claims that may be made against the Indemnitee; (ii) the
sole relief provided is monetary damages that are paid in full by the
Indemnifying Party; and (iii) the Indemnitee’s rights under this Agreement are
not adversely affected.  If the Indemnifying Party fails to assume defense of a
Claim within a reasonable time, the Indemnitee may settle such Claim on such
terms as it deems appropriate with the consent of the Indemnifying Party (which
consent shall not be unreasonably withheld), and the Indemnifying Party will be
obligated to indemnify the Indemnitee for such settlement as provided in this
Article 14.

 

14.4        Insurance.  Each Party shall, at its own expense, procure and
maintain during the Term and for a period of five (5) years thereafter,
insurance policy/policies, including product liability insurance, adequate to
cover its obligations hereunder and which are consistent with normal business
practices of prudent companies similarly situated.  Such insurance shall not be
construed to create a limit of a Party’s liability with respect to its
indemnification obligations under this Article 14.  Each Party shall provide the
other Party with written evidence of such insurance or self-insurance upon
request.  Each Party shall provide the other Party with prompt written notice of
cancellation, non-renewal or material change in such insurance self-insurance,
which could materially adversely affect the rights of such other Party
hereunder, and shall provide such notice within thirty (30) days after any such
cancellation, non-renewal or material change.

 

15.          DISPUTE RESOLUTION

 

15.1        Objective.  The Parties recognize that disputes as to matters
arising under or relating to this Agreement or either Party’s rights and/or
obligations hereunder may arise from time to time.  It is the objective of the
Parties to establish procedures to facilitate the resolution of such disputes in
an expedient manner by mutual cooperation and without resort to litigation.  To
accomplish this objective, the Parties agree to follow the procedures set forth
in this Article 15 to resolve any such dispute if and when it arises.  For the
avoidance of doubt, both Parties acknowledge and agree that notwithstanding
anything to the contrary contained in this Agreement, the following shall not be
subject to the dispute resolution provisions contained in Sections 15.2 and
15.3: (i) final decisions made by [***] pursuant to its rights under [***];
(ii) failure of the OSC to unanimously decide (a) [***], or (b) whether to
[***]; and (iii) termination by either Party for safety reasons under
Section 13.2.3(a).  For clarification, the determination by either Party that a
safety issue exists that would permit termination of this

 

*** Confidential Treatment Requested

 

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Agreement under Section 13.2.3(a) shall not be subject to the dispute resolution
provisions contained in Sections 15.2 and 15.3; provided, however, that, if a
Party believes in good faith that the election by the other Party to terminate
this Agreement under Section 13.2.3(a) was a breach of this Agreement because
the electing Party had not in fact determined that a safety issue permitting
such termination existed, then such dispute shall be subject to the dispute
resolution provisions contained in Sections 15.2 and 15.3.

 

15.2        Resolution by Senior Executives.  Except as otherwise provided in
this Agreement including Section 15.1, if an unresolved dispute as to matters
arising under or relating to this Agreement or either Party’s rights and/or
obligations hereunder arises, either Party may refer such dispute to the Chief
Executive Officers of each of Takeda and Amylin (or such delegate of either
Chief Executive Officer who shall have appropriate decision making authority
regarding such dispute), who shall meet in person or by telephone within [***]
after such referral to attempt in good faith to resolve such dispute.  If such
matter cannot be resolved by discussion of Chief Executive Officers, or their
respective delegates, within such [***] period (as may be extended by mutual
written agreement), such dispute shall be resolved in accordance with
Section 15.3.

 

15.3        Arbitration.  Any dispute that is not resolved as provided in
Section 15.2 may be referred to arbitration by either Party.  Such arbitration
shall be conducted in accordance with the Rules of Arbitration of the
International Chamber of Commerce (the “ICC Rules”) as then in effect.  The
arbitration shall be held solely in New York, New York, U.S.A, and shall be
conducted in English before an arbitration panel comprised of three
(3) arbitrators, who shall be selected as follows: (i) each Party shall select
one (1) arbitrator within twenty (20) days after the date on which one of the
Parties makes a written demand for arbitration in accordance with the ICC Rules;
and (ii) the third arbitrator, who shall act as chairman of the arbitration
panel, shall be selected by the other two (2) arbitrators within twenty (20)
days after the selection of the other two (2) arbitrators; provided, however, in
the event that a Party fails to select an arbitrator, or the two (2) arbitrators
selected by the Parties fail to select the third arbitrator in accordance with
this Section 15.3, such arbitrator(s) shall be selected by the Chairman of the
International Chamber of Commerce upon the written request of either Party. The
decision and award of the arbitrators in any arbitration proceeding between the
Parties under this Section 15.3 shall be: (a) in writing, stating the reasons
for such decision; (b) based solely on the terms and conditions of this
Agreement, as interpreted in accordance with the laws of the State of New York,
U.S.A.; (c) final and binding upon the Parties hereto; and (d) enforceable in
any court of competent jurisdiction.  The fees and expenses of the arbitration
shall be shared equally by the Parties.

 

15.4        Court Actions. The dispute resolution process described in
Section 15.3 shall be employed in lieu of litigation in a court of law, except
in the following circumstances:  (i) either Party shall be permitted to seek a
preliminary injunction or other equitable remedy in the courts to preserve
rights, which may otherwise be lost or encumbered in the absence of injunctive
relief, or to preserve the status quo including, but not limited to, preserving
the confidentiality of Confidential Information; and (ii) any dispute,
controversy or claim relating to the scope, validity, enforceability or
infringement of any Patents or any trademark relating to any Licensed Compound
or Product that is the subject of this Agreement shall be submitted to a court
of competent jurisdiction in which such Patent or trademark rights were granted
or arose.

 

*** Confidential Treatment Requested

 

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16.          MISCELLANEOUS

 

16.1        Standstill Agreement.  Until the date that is three (3) years after
the Effective Date (the “Standstill Period”), none of Takeda, Takeda’s
Affiliates, nor any of their respective directors, officers, employees, agents
or representatives (provided such person is acting on behalf of Takeda) will, in
any manner, directly or indirectly, without the prior express written consent of
Amylin (provided that the foregoing shall not limit Takeda’s obligations under
this Section 16.1):

 

(a)           acquire, offer to acquire or agree to acquire, alone or in concert
with any other Person, by purchase, tender offer, exchange offer, agreement or
business combination or any other manner: (i) beneficial ownership of any
securities of Amylin or any securities of any Affiliate of Amylin, if, after
completion of such acquisition or proposed acquisition, Takeda would
beneficially own more than nine and 99/100 percent (9.99%) of the outstanding
shares of common stock of Amylin (the “Common Stock”); (ii) any assets of Amylin
or any assets of any Affiliate of Amylin, other than non-material acquisitions
in the ordinary course of business;

 

(b)           initiate, participate in or enter into any merger, business
combination, recapitalization, restructuring, liquidation, dissolution or
similar extraordinary transaction involving Amylin or any Affiliate of Amylin,
or involving any securities or assets of Amylin or any securities or assets of
any Affiliate of Amylin;

 

(c)           “solicit” “proxies” (as those terms are used in the proxy rules of
the Securities and Exchange Commission) or consents with respect to any
securities of Amylin;

 

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

 

(e)           act, alone or in concert with others, to seek to control the
management, board of directors or policies of Amylin;

 

(f)            take any action that would reasonably be expected to require
Amylin to make a public announcement regarding any of the types of matters set
forth in clause “(a)”, “(b)”, “(c)” or “(d)” of this sentence;

 

(g)           agree, offer to take, propose, assist, induce or encourage any
other Person to take, publicly or otherwise, any action of the type referred to
in clause “(a)”, “(b)”, “(c)”, “(d)”, “(e)” or “(f)” of this sentence;

 

(h)           enter into any discussions, negotiations, arrangements or
agreements with any other Person relating to any of the foregoing; or

 

(i)            request or propose that Amylin or any of Amylin’s representatives
amend, waive or consider the amendment or waiver of any of the provisions set
forth in this Section 16.1.

 

Notwithstanding the restrictions contained in the foregoing clauses “(a)”
through “(i)”: (1) Takeda shall not be prohibited from entering into an
agreement and having discussions

 

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with legal, accounting, or financial advisors for the limited purposes of
evaluating any of the transactions contemplated in clause “(a)”, “(b)”, “(c)”,
“(d)”, “(e)” or “(f)” of this sentence; and (2) so long as Takeda has not
violated the provisions of clauses “(a)” through “(i)” inclusive, Takeda may
inform Amylin or Amylin’s Representatives privately that Takeda alone, and not
in concert with others, would be interested in engaging in discussions with
Amylin that could result in a negotiated transaction described in clause “(a)”
or “(b)” so long as, (x) Takeda does not propose any such transaction unless
Amylin requests Takeda to make such a proposal, (y) Takeda does not seek any
amendment or waiver of any provision of this Section 16.1, and (z) Takeda does
not take any action that would reasonably be expected to require Amylin to make
any public announcement.

 

Notwithstanding the restrictions contained in the foregoing “(a)” through “(i)”,
the provisions of this Section 16.1 shall not apply to:

 

(i)            the exercise by Takeda of any of its rights under this Agreement;

 

(ii)           the exercise by Takeda as an Amylin stockholder, if applicable,
of any voting rights available to Amylin stockholders generally pursuant to any
transaction described in subparagraph “(a)(ii)” or “(b)” above, provided that
Takeda has not then either directly, indirectly, or as a member of a Group made,
effected, initiated or caused such transaction to occur;

 

(iii)          any activity by Takeda after Amylin, or any Third Party unrelated
to Takeda, has made any public announcement of its intent to solicit or engage
in any transaction which would result in a Change in Control of Amylin, or after
any such Change in Control of Amylin shall have occurred; or

 

(iv)          any investment by Takeda or an Affiliate of Takeda in third-party
mutual funds or other similar passive investment vehicles that hold interests in
securities of Amylin or any of its Affiliates (and any such interests in
securities shall not be taken into account for the purpose of subparagraph
(a) including the nine and 99/100 percent (9.99%) exception contained therein),
provided that the provisions of this clause (iv) shall apply with respect to any
such fund or vehicle only for so long as such fund or vehicle satisfies the
requirements of paragraphs (i) and (ii) of Rule 13d-1(b)(1) promulgated under
the Securities Exchange Act of 1934, as amended, with respect to any Amylin
securities held by such fund or vehicle.

 

Except as provided for below, the restrictions of this Section 16.1 shall no
longer be applicable in the event of any of the following:

 

(A)          the acquisition by any Third Party of beneficial ownership of more
than fifteen percent (15%) of the outstanding Common Stock;

 

(B)           the announcement or commencement by any Person or Group of a
tender offer or exchange offer to acquire securities of Amylin which, if
successful, would result in such Person or Group owning, when combined with any
other securities owned by such Person or Group, fifty percent (50%) or more of
the then outstanding Common Stock;

 

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(C)           Amylin enters into a definitive written merger, sale or other
business combination agreement pursuant to which fifty percent (50%) or more of
the outstanding Common Stock of Amylin would be converted into cash or
securities of another Person or Group or, immediately after the consummation of
such transaction, fifty percent (50%) or more of the then outstanding Common
Stock would be owned by Persons other than the holders of Common Stock
immediately prior to the consummation of such transaction, or which would result
in all or substantially all of Amylin’s assets being sold to any Person or
Group;

 

(D)          Amylin or any of its Affiliates becomes the subject of any
bankruptcy, insolvency or similar proceeding (except for any involuntary
proceeding that is dismissed within 60 days); or

 

(E)           Amylin engages in the solicitation of one (1) or more Third Party
bids for any transaction which would result in a Change of Control of Amylin.

 

The provisions of this Section 16.1 shall again be applicable if: (1) Amylin or
such Third Party, Person or Group, as applicable, terminates or announces its
intent not to proceed with any transaction referred to in clauses (iii), (B),
(C) or (E) above, as applicable, or, in the case of clause (D) above, Amylin and
its Affiliates shall cease to be the subject of any such bankruptcy, insolvency
or similar proceeding, as applicable; and (2) either (x) Takeda has not
previously made any public announcement of its intent to solicit or engage in
any transaction of the type referred to in clauses (iii), (B), (C) or (E) above,
or (y) in the event such a public announcement has been made by Takeda, Takeda
has terminated or announced its intent to terminate such transaction.

 

If, during the Standstill Period, Amylin enters into any development and
commercialization agreement with a Third Party that is similar in size and scope
to this Agreement (the “Third Party Agreement”), which does not contain
provisions restricting the activities of such Third Party that, taken as a whole
(the “Third Party Standstill Provisions”), are at least as onerous to the Third
Party as the provisions of this Section 16.1, then, upon the effective date of
the Third Party Agreement, the provisions of this Section 16.1 shall
automatically be deemed modified without further action so as to conform to the
Third Party Standstill Provisions.  For the avoidance of doubt, the Parties
agree that if the Third Party Agreement contains no standstill provision, this
Section 16.1 shall terminate in its entirety upon the effective date of the
Third Party Agreement.

 

The expiration of the Standstill Period will not terminate or otherwise affect
any of the provisions of this Agreement other than this Section 16.1.

 

16.2        Force Majeure.  Neither Party shall be held liable to the other
Party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in performing any obligation under this Agreement when such
failure or delay is caused by or results from an event of force majeure;
provided, however, with respect to a failure to make payment due to an event of
force majeure, the non-performing Party shall be required to make such payment
as quickly as possible, but in any event, even if the force majeure continues,
within two (2) months from the date that the force majeure began; provided,
further, that in the event that an event of force majeure prevents either Party
from making any payment to the other Party in a timely

 

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manner, as provided in Article 9 hereof, interest on such unpaid amount shall
nonetheless accrue in accordance with the provisions of Section 9.5.  For
purposes of this Section 16.2, an event of force majeure shall mean and include
any causes beyond the reasonable control of the affected Party including, but
not limited to, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, fire, floods, or other acts of God, or acts, omissions or delays
in acting by any governmental authority (including, but not limited to, the
refusal of the competent government agencies to issue required Regulatory
Approvals due to reasons other than the affected Party’s negligence or willful
misconduct or any other cause within the reasonable control of the affected
Party).  The affected Party shall notify the other Party of such force majeure
event as soon as reasonably practical, and shall promptly undertake all
Commercially Reasonable Efforts necessary to cure such force majeure event.
 Such excuse from liability shall be effective only to the extent and duration
of the force majeure event(s) causing the failure or delay in performance and
provided that the Party has not caused such event(s) to occur.

 

16.3        Assignment.  Except as expressly provided hereunder, neither this
Agreement nor any rights or obligations hereunder may be assigned or otherwise
transferred by either Party without the prior written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
it shall not be unreasonable for a Party to refuse to authorize any assignment
(other than to an Affiliate, as provided in Section 16.3(b) below) proposed by
the other Party in the event that: (i) such Party reasonably determines that the
proposed assignee does not have the financial, technical and/or marketing
resources to perform the other Party’s obligations hereunder; (ii) the proposed
assignee is engaged in any litigation, arbitration or an other legal proceeding
of a material nature as an adverse party to such Party; or (iii) the proposed
assignee has infringed any of the intellectual property rights hereunder,
misappropriated or misused any of Confidential Information, or engaged in any
other unfair or unethical business practices. Notwithstanding the foregoing,
Amylin may assign its right to receive payments under this Agreement without
Takeda’s prior written consent and either Party may assign this Agreement and
its rights and obligations hereunder without the other Party’s consent:

 

(a)           in connection with the transfer or sale of all or substantially
all of the business of such Party to a Third Party, whether by merger, sale of
stock, sale of assets or otherwise, provided that in the event of a transaction
(whether this Agreement is actually assigned or is assumed by the acquiring
Third Party by operation of law (e.g., in the context of a reverse triangular
merger)), intellectual property rights of the acquiring Third Party in such
transaction (if other than one of the Parties to this Agreement) shall not be
included in the intellectual property rights licensed under this Agreement; or

 

(b)           to an Affiliate, provided that the assigning Party shall remain
liable and responsible to the non-assigning Party hereto for the performance and
observance of all such duties and obligations by such Affiliate.

 

Notwithstanding anything to the contrary contained in this Agreement, upon a
Change of Control of either Party, the other Party will have final decision
making authority for all decisions made by the OSC and ODC with respect to
Development and Commercialization matters.  A “Change of Control” of a Party
shall occur if: (i) any Third Party acquires directly or indirectly the
beneficial ownership of any voting security of such Party, or if the percentage
ownership of

 

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such person or entity in the voting securities of such Party is increased
through stock redemption, cancellation or other recapitalization, and
immediately after such acquisition or increase such Third Party is, directly or
indirectly, the beneficial owner of voting securities representing more than
fifty percent (50%) of the total voting power of all of the then-outstanding
voting securities of such Party; (ii) the consummation of a merger,
consolidation, recapitalization, or reorganization of such Party, other than any
such transaction, which would result in stockholders or equity holders of such
Party, or an Affiliate of such Party, immediately prior to such transaction
owning at least fifty percent (50%) of the outstanding securities of the
surviving entity (or its parent entity) immediately following such transaction;
or (iii) the stockholders or equity holders of such Party approve a plan of
complete liquidation of such Party, or an agreement for the sale or disposition
by such Party of all or a substantial portion of such Party’s assets, other than
pursuant to the transaction as described above or to an Affiliate.

 

This Agreement shall be binding upon successors and permitted assigns of the
Parties.  Any assignment not in accordance with this Section 16.3 will be null
and void.

 

16.4        Limitation of Liability.  EXCEPT FOR EACH PARTY’S OBLIGATIONS WITH
RESPECT TO THE INTELLECTUAL PROPERTY RIGHTS AS PROVIDED IN ARTICLE 12, AND EACH
PARTY’S OBLIGATIONS WITH RESPECT TO THE OTHER PARTY’S CONFIDENTIAL INFORMATION
AS PROVIDED IN ARTICLE 10, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE
OTHER PARTY ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES
IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER INCLUDING,
BUT NOT LIMITED TO, LOST PROFITS, LOST SALES OR LOSS OF GOODWILL, EVEN IF THAT
PARTY HAS BEEN PLACED ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED,
HOWEVER, THAT THIS SECTION 16.4 SHALL NOT BE CONSTRUED TO LIMIT EITHER PARTY’S
INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 14, AND IN NO EVENT SHALL PAYMENTS DUE
AND OWING UNDER ARTICLE 8 BE CONSIDERED SPECIAL, INDIRECT, INCIDENTAL,
CONSEQUENTIAL, OR PUNITIVE DAMAGES.

 

16.5        Severability.  If any one or more of the provisions contained in
this Agreement is held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless the absence
of the invalidated provision(s) adversely affects the substantive rights of the
Parties.  The Parties shall in such an instance negotiate in good faith and use
Commercially Reasonable Efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s) which, insofar as
practical, implement the purposes of this Agreement.

 

16.6        Notices.  All notices which are required or permitted hereunder
shall be in writing and sufficient if delivered personally, sent by facsimile
(and promptly confirmed by personal delivery, registered or certified mail or
overnight courier), sent by nationally-recognized overnight courier or sent by
registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:

 

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If to Amylin, addressed to:

 

Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, CA 92121, U.S.A.

Attention: Chief Executive Officer

Fax: (858) 552-2212

 

With a required copy to:

 

Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, CA 92121, U.S.A.

Attention: General Counsel

Fax: (858) 552-1936

 

If to Takeda, addressed to:

 

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku

Osaka 540-8645, Japan

Attention: General Counsel, Legal Department

Fax: +81 6 6204-2880

 

With a required copy to:

 

Takeda Pharmaceuticals North America, Inc.

One Takeda Parkway

Deerfield, Illinois 60015

Attention: General Counsel, Legal Department

Fax: (224) 554-7831

 

or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith.  Any such notice
shall be deemed to have been given: (i) when delivered if personally delivered
or sent by facsimile on a business day; (ii) on the business day after dispatch
if sent by nationally recognized overnight courier; and/or (iii) on the third
(3rd) business day following the date of mailing if sent by mail.

 

16.7        Applicable Law.  Except as otherwise provided for in this Agreement,
including in Section 15.4, this Agreement and all questions regarding its
existence, validity, interpretation, breach or performance, shall be governed
by, and construed and enforced in accordance with, the laws of the State of New
York, United States, without reference to its conflicts of law principles with
the exception of Sections 5-1401 and 5-1402 of New York General Obligations Law;
provided, however, that: (i) the validity or enforcement of all Amylin
Technology or Takeda Technology hereunder shall be determined under the laws of
that jurisdiction in which the Amylin Technology or Takeda Technology is
registered or for which an application for registration has been filed; and
(ii) the use in the Territory of the Product trademarks and other unregistered
Amylin Technology or Takeda Technology shall be governed by Applicable Law.

 

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The United Nations Conventions on Contracts for the International Sale of Goods
shall not be applicable to this Agreement.

 

16.8        Entire Agreement; Amendments.  This Agreement, together with the
Exhibit hereto, contains the entire understanding of the Parties with respect to
the subject matter hereof and supersedes and cancels all previous express or
implied agreements and understandings, negotiations, writings and commitments,
either oral or written, in respect to the subject matter hereof.  In the event
of any conflict between the terms of this Agreement and any provisions contained
in the Exhibits to this Agreement, the terms of this Agreement shall prevail. 
This Agreement may be amended, or any term hereof modified, only by a written
instrument duly executed by authorized representatives of both Parties hereto.

 

16.9        Headings.  The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are merely for convenience to assist in
locating and reading the several Articles and Sections hereof.

 

16.10      Independent Contractors.  It is expressly agreed that Amylin and
Takeda shall be independent contractors and that the relationship between the
two Parties shall not constitute a partnership, joint venture or agency. 
Neither Amylin nor Takeda shall make, nor have the authority to make, any
statements, representations or commitments of any kind, or to take any action,
which shall be binding on the other Party, without the prior written consent of
the other Party.

 

16.11      Waiver.  The failure by either Party hereto to assert any of its
rights hereunder, including, but not limited to, the right to terminate this
Agreement due to a breach or default by the other Party hereto, shall not be
deemed to constitute a waiver by that Party of its right thereafter to enforce
each and every provision of this Agreement in accordance with its terms.  No
waiver by either Party of any provision of this Agreement shall be effective
unless made in writing and signed by the Party granting such waiver.

 

16.12      Cumulative Remedies.  No remedy referred to in this Agreement is
intended to be exclusive, but each shall be cumulative and in addition to any
other remedy referred to in this Agreement or otherwise available under law.

 

16.13      Waiver of Rule of Construction.  Each Party has had the opportunity
to consult with counsel in connection with the review, drafting and negotiation
of this Agreement.  Accordingly, the rule of construction that any ambiguity in
this Agreement shall be construed against the drafting Party shall not apply.

 

16.14      Interpretation.  All references in this Agreement to an Article,
Section or Exhibit shall refer to an Article, Section or Exhibit in or to this
Agreement, unless otherwise stated.  Any reference to any federal, national,
state, local, or foreign statute or law shall be deemed also to refer to all
rules and regulations promulgated thereunder, unless the context requires
otherwise.  The word “including” and similar words means including without
limitation.  The words “herein,” “hereof” and “hereunder” and other words of
similar import refer to this Agreement as a whole and not to any particular
Article or Section or other subdivision.  All references to days,

 

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months, quarters or years are references to calendar days, calendar months,
calendar quarters, or calendar years, unless stated otherwise.  References to
the singular include the plural.

 

16.15      No Third Party Beneficiaries.  This Agreement is neither expressly
nor impliedly made for the benefit of any party other than Amylin and Takeda.

 

16.16      English Language.  This Agreement is in the English language, and the
English language shall control their interpretation.  In addition, all notices
required or permitted to be given under this Agreement, and all written,
electronic, oral or other communications between the Parties regarding this
Agreement, shall be in the English language.

 

16.17      Counterparts.  This Agreement may be executed in multiple
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

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IN WITNESS WHEREOF, the Parties hereto have duly executed this LICENSE,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT as of the Effective Date.

 

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED

 

AMYLIN PHARMACEUTICALS, INC.

 

 

 

 

 

 

By:

/s/ Yasuchika Hasegawa

 

By:

/s/ Daniel M. Bradbury

 

 

 

Name: Yasuchika Hasegawa

 

Name: Daniel M. Bradbury

 

 

 

Title: President & CEO

 

Title: President & CEO

 

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Exhibit A

 

Amylin Patents as of the Effective Date

 

[***]

 

*** Confidential Treatment Requested

 

A-1

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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit B

 

Development Plan Through [***]

 

The following timelines represent the most current version of the clinical
development portion of the overall Development Plan.  Within [***] after the
Effective Date, the Parties shall update and amend, and confirm through the ODC
and OSC, the Development Plan to include a comprehensive Development Budget and
CMC, toxicology and additional or revised clinical or non-clinical activities,
all in accordance with Section 3.1 of the Agreement.

 

Name: [***]

 

Indication: Obesity

 

[***]

 

*** Confidential Treatment Requested

 

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Name: [***]

 

Indication: Obesity

 

[***]

 

Name: [***]

 

Indication: Obesity

 

[***]

 

*** Confidential Treatment Requested

 

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Name: [***]

 

Indication: Obesity

 

[***]

 

*** Confidential Treatment Requested

 

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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit C

 

Analogs of MetreLeptin

 

1.             [***]

2              [***]

 

*** Confidential Treatment Requested

 

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit D

 

Co-Commercialization Agreement Terms

 

The Co-Commercialization Agreement shall include the following terms and
conditions, unless otherwise mutually agreed by the Parties, in addition to such
terms and conditions as are customarily contained in similar agreements in the
pharmaceutical industry and such other terms and conditions as the Parties may
agree upon:

 

1.             Commercialization right.  Amylin shall be entitled to participate
in the Commercialization of the Products as follows:  (i) through membership in
the OCC; (ii) performing a portion of the Detailing efforts for Products,
subject to the limits described in Section 5.3 of the Agreement; and
(iii) conducting such other activities necessary to support its PDE obligations.
The Co-Commercialization Agreement shall be structured to reflect the following:

 

·                  The number of PDEs to be performed annually by Amylin for
Products will be mutually agreed by the Parties; provided that Amylin shall
perform not more than [***] percent ([***] %) of the aggregate number of PDEs
specified in the Commercialization Plan for each Product;

 

·                  The allocation of Details to be performed by Amylin will be
determined by Takeda, with input from Amylin, taking into consideration
prescribing levels, geographic territory, centers of excellence, target groups,
Detail position and other relevant considerations as Takeda may determine.

 

·                  Amylin will maintain [***] percent ([***] %) adherence to its
PDE requirement under the call plan for the Takeda Detail allocation.

 

·                  Amylin shall implement and maintain an appropriate incentive
plan for the sale of the Product for its sales force that provides an incentive
on an interval to be specified in the Co-Commercialization Agreement, and shall
be weighted at a level commensurate with the Product Detail position for the
Product as compared with the total number of products handled by such Medical
Sales Representative, but not less than [***] percent ([***] %).

 

·                  Amylin will provide PDEs in accordance with the applicable
Commercialization Plan.

 

2.             Co-Commercialization expenses.  Except as otherwise specifically
provided in this Exhibit D, Amylin will be responsible for all costs and
expenses of its Commercialization activities under the Co-Commercialization
Agreement, including, without limitation, costs and expenses of its Medical
Sales Representatives.

 

3.             PDE Reimbursement.  Following the end of each calendar quarter,
Takeda will pay Amylin an amount equal to [***] percent ([***] %) of Takeda’s
then-current fully burdened internal PDE costs for each PDE performed by Amylin
during such calendar quarter.

 

*** Confidential Treatment Requested

 

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4.             Detail and Sample Reporting.

 

·                  Amylin will maintain complete and accurate records of each
PDE performed by its Medical Sales Representatives using a call document which
records the name and address of each target prescriber, the date and position of
the PDE, the number of samples delivered and any other information reasonably
requested by Takeda.

 

·                  Amylin will provide Takeda with a monthly written report of
the number of total PDEs delivered, and any other information reasonably
requested by Takeda, in a form agreed upon by the Parties.  The monthly report
shall be provided to Takeda no later than the 10th calendar day of the following
month, or within such timeframe as is consistent with Amylin’s then-current
systems and processes for creating such written reports.

 

·                  Takeda shall determine sampling procedures to be followed by
Amylin, if applicable, with input with Amylin.

 

·                  Takeda shall have the right to perform audits of Amylin’s
files, records, databases, etc. to confirm the accuracy of any PDE or sample
reports provided under the Co-Commercialization Agreement.

 

5.             Performance Standards.

 

·                  Amylin will use Commercially Reasonable Efforts to
Commercialize the Products and will perform its Commercialization obligations in
accordance with the Agreement, the Co-Commercialization Agreement and the
applicable Commercialization Plan.

 

·                  Amylin shall comply with all laws, rules and regulations
applicable to the marketing, sale and promotion of pharmaceutical products,
including, without limitation, the statutes, regulations and written directives
of the FDA, including the FD&C Act, the Prescription Drug Marketing Act, the
Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the
statutes, regulations and written directives of Medicare, Medicaid and all other
health care programs, as defined in 42 U.S.C. §1320a-7b(f) the Health Insurance
Portability and Accountability Act of 1996, the Pharmaceutical Research and
Manufacturers of America Code on Interactions with Healthcare Professionals, and
the American Medical Association Guidelines on Gifts to Physicians from
Industry, each as may be amended from time to time.  Consistent with the
“Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the
Office of Inspector General, U.S. Department of Health and Human Services (the
“OIG Guidance”), Amylin agrees to maintain a compliance program with respect to
its promotional and sales activities relating to the Products containing all of
the elements described in such guidance document.  Upon Takeda’s request, Amylin
will provide Takeda with copies of its policies for such compliance programs.

 

6.             Promotional Materials and Samples.  Takeda will provide to Amylin
reasonable quantities of promotional materials and samples and/or sample
vouchers for Products to support Amylin’ Co-Commercialization activities.

 

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·                  Takeda will provide such materials to Amylin at Takeda’s sole
expense;

 

·                  Amylin shall not, and shall ensure that its Medical Sales
Representatives do not, make any changes to the promotional materials.

 

7.             Training and Related Amylin Sales Force Issues.  Takeda shall
provide initial training to Amylin’ sales managers and trainers (i.e.,
“train-the-trainer”) at Takeda’s expense. Thereafter, Amylin will be responsible
for conducting training for its own sales forces.  Takeda will be responsible
for designing training materials, approving participation and representation at
meetings, and will ship training materials to Amylin as reasonably required for
Amylin’ ongoing training needs at Takeda’s expense.

 

·                  At the request of a Party, such Party’s trainers may
participate in the other Party’s training programs specific to Products.

 

·                  Amylin shall be responsible, at Takeda’s expense, for the
training of its sales force specifically related to the launch of a Product.

 

·                  Amylin shall be responsible, at its expense, for establishing
ongoing training (other than the training provided by Takeda), supervising and
maintaining its Medical Sales Representatives.

 

·                  Amylin will be permitted to participate in any speaker
meetings, advisory board meetings and/or promotional events (including, but not
limited to, displays and exhibit booths) related to the Product in a manner
consistent with the participation of Takeda’s personnel and polices.

 

8.             Term and Termination.

 

·                  The term of the Co-Commercialization Agreement shall commence
on the effective date of the Co-Commercialization Agreement and shall continue
in effect for a period of [***]; provided that the term may be extended for an
additional [***]: (i) by mutual agreement of the Parties; or (ii) at Amylin’s
sole option, if, during discussions by the Parties relating to such extension,
Takeda expresses its intention to use a contract sales organization during the
period of the [***] extension.  Amylin must exercise its option to extend not
later than [***] prior to the expiration of the first [***] term.

 

·                  The Co-Commercialization Agreement shall contain reasonable
and appropriate termination rights, including without limitation, Takeda’s right
to terminate in the event of: (i) a Change of Control of Amylin (as defined in
the Agreement); and (ii) Amylin’s failure to meet its PDE obligation after a
reasonable opportunity to cure, which shall not exceed a period of [***].

 

9.             Medical Inquires.  Takeda will establish procedures for handling
any medical inquires from health care professionals or others and any requests
for medical information about the Product.

 

*** Confidential Treatment Requested

 

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

10.          Adverse Events.  The Parties will establish a process for
communicating and reporting any adverse events and complaints relating to the
Products in accordance with the pharmacovigilance agreement described in
Section 4.4 of the Agreement.

 

11.          Non-Solicitation.  During the term of the Co-Commercialization
Agreement and for twelve (12) months thereafter, neither Party will recruit or
solicit, directly or through a Third Party, for employment or otherwise, any
Medical Sales Representative and associated field support of the other Party
without the written consent of the other Party.

 

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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit E

 

Takeda Y-family Agonists

 

1.                                       [***]

 

*** Confidential Treatment Requested

 

E-1

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit F

 

In-License Agreements

 

License Agreement between Amgen Inc. and Amylin, dated February 7, 2006, as
amended.

 

License Agreement between Curis Inc. and Amylin, dated December 4, 2002, as
amended.

 

Development and License Agreement between Pacira Pharmaceuticals, Inc. and
Amylin, dated as of March 31, 2008, as amended.

 

Confidential Agreement and Release of All Claims among the University of
Minnesota and Per Westermark and Amylin, dated October 21, 1998, as amended.

 

 

F-1

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Commission.  Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit G

 

[***]

 

*** Confidential Treatment Requested

 

G-1

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