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


 


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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***Text
Omitted and Filed Separately with the Securities and Exchange


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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Commission.  Confidential Treatment Requested Under


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


 


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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Commission.  Confidential Treatment Requested Under


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


 


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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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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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Commission.  Confidential Treatment Requested Under


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 


 


5

















 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


; 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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Commission.  Confidential Treatment Requested Under


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


 


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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Commission.  Confidential Treatment Requested Under


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


 


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.


 


***
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Commission.  Confidential Treatment Requested Under


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


 


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


 


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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and 240.24b-2


 


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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Commission.  Confidential Treatment Requested Under


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


 


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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and 240.24b-2


 


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 


 


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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


 


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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and 240.24b-2


 


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


 


***
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with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Confidential Treatment Requested


 


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Omitted and Filed Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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 


 


***
Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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


 


***
Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Omitted and Filed Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Omitted and Filed Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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240.24b-2


 


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


 


*** Confidential Treatment Requested


 


34






 










 


***Text Omitted and Filed
Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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 


 


***
Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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


 


***
Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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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Commission.  Confidential Treatment Requested Under


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


 


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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Commission.  Confidential Treatment Requested Under


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


 


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


 


***
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


 


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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Commission.  Confidential Treatment Requested Under


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


 


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$[***]

  	
   

  



 


***
Confidential Treatment Requested


 


41

















 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


	
  [***]

  	
   

  	
  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


 


***
Confidential Treatment Requested


 


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Separately with the Securities and Exchange


Commission.  Confidential Treatment Requested Under


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


 


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.


 


***
Confidential Treatment Requested


 


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


 


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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Commission.  Confidential Treatment Requested Under 


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


 


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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Commission.  Confidential Treatment Requested Under 


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


 


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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Commission.  Confidential Treatment Requested Under 


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


 


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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Commission.  Confidential Treatment Requested Under 


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


 


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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200.80(b)(4) and 240.24b-2


 


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


 


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


 


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


 


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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and 240.24b-2


 


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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and 240.24b-2


 


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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and 240.24b-2


 


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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and 240.24b-2


 


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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and 240.24b-2


 


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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and 240.24b-2


 


[***] 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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and 240.24b-2


 


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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and 240.24b-2


 


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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and 240.24b-2


 


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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Commission.  Confidential Treatment Requested Under


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


 


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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and 240.24b-2


 


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


 


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Commission.  Confidential Treatment Requested Under


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


 


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.


 


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Commission.  Confidential Treatment Requested Under


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


 


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


 


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Confidential Treatment Requested Under


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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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Exhibit C


 


Analogs of MetreLeptin


 


1.             [***]


2              [***]


 


*** Confidential Treatment Requested


 


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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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Commission.  Confidential Treatment Requested Under


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


 


Exhibit E


 


Takeda Y-family Agonists


 


1.                                       [***]


 


*** 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 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