Exhibit
10.43


 


***Text Omitted and Filed Separately


Confidential Treatment Requested


Under 17 C.F.R. §§ 200.80(b)(4)


And 240.24b-2


 


COMMERCIAL SUPPLY AGREEMENT


 


This Commercial Supply Agreement (this “Agreement”) is entered into and
effective this 14th day of February, 2005 (the “Effective Date”) by and between
Baxter Pharmaceutical Solutions LLC (“BAXTER”),
a Delaware limited liability company having a place of business at 927 South
Curry Pike, Bloomington, Indiana 47403, and Amylin Pharmaceuticals, Inc. (“AMYLIN”), a Delaware corporation having a
principal place of business at 9360 Towne Centre Drive, Suite 110, San Diego,
California 92121.


 


RECITALS


 


1.             AMYLIN
is engaged in the development of pharmaceutical products;


 


2.             BAXTER
is engaged in the filling, labeling and packaging of pharmaceutical products;


 


3.             AMYLIN and BAXTER are
parties to a Drug Product Development Agreement dated February 27, 2004 (the “Development
Agreement”), related to the Product (as defined below); and


 


4.             AMYLIN and BAXTER
desire to have BAXTER fill, package, inspect, label, and test Product for
distribution and sale by AMYLIN.


 


NOW, THEREFORE, in
consideration of the mutual covenants and agreements contained herein, the
parties agree as follows:


 


Article 1.  DEFINITIONS


 


As used in this Agreement, the following words and phrases shall have
the following meanings:


 


1.1           “Affiliate”
of a party hereto shall mean any entity that controls or is controlled by such
party, or is under common control with such party.  For purposes of this definition, an entity
shall be deemed to control another entity if it owns or controls, directly or
indirectly, at least fifty percent (50%) of the voting equity of another entity
(or other comparable ownership interest for an entity other than a corporation).


 





















 


1.2           “AMYLIN
Trademarks” shall mean the proprietary mark(s) for Product owned by
AMYLIN.


 


1.3           “Annual Forecast” shall be defined in Section 4.1.


 


1.4           “Annual Obligation” shall be defined in Section 4.3.


 


1.5           “Batch” shall mean a specific quantity of a Product or
placebo comprising a number of Units mutually agreed upon between AMYLIN and
BAXTER, and that (a) is intended to have uniform character and quality within
specified limits, and (b) is Produced according to a
single manufacturing order during the same cycle of Production.


 


1.6           “Collaboration Partner” shall mean Eli
Lilly and Company, or its successor, with whom AMYLIN has entered into a
collaboration arrangement regarding Product.


 


1.7           “Components” shall mean all Components used
by BAXTER in the Production of Product under this Agreement.  Components are listed in Exhibit D, such
Components identified as Components supplied by AMYLIN (“AMYLIN Supplied
Components”) and Components supplied by BAXTER (“BAXTER Supplied Components”).


 


1.8           “Component Specifications” shall mean the
specifications and testing to be performed for the Components, as set forth in
Exhibit D.


 


1.9           “Confidential
Information” shall mean all information and data provided by one
party to the other party except any portion of such information and data which:


 


(i)            is known to the recipient as evidenced by
its written records before receipt thereof from the disclosing party;


 


(ii)           is disclosed to the recipient, as demonstrated by competent
evidence, by a third person who has the right to make such disclosure;


 


(iii)          is or becomes part of the public domain through no fault of
the recipient; or


 


(iv)          the recipient can reasonably establish is independently
developed by recipient without use of the information disclosed by the
disclosing party.


 


1.10         “Contaminant”
shall mean any substance contained in Product that (a) causes Product to fail
to meet Product Requirements, (b) causes Product to be adulterated


 





















 


within the
meaning of the FD&C Act, or (c) is present in Product at a level that exceeds
the level allowed under cGMP.


 


1.11         “Current Good Manufacturing Practices” or “cGMP” shall mean (a) the good
manufacturing practices required by the FDA and set forth in the FD&C Act
or FDA Regulations (including without limitation 21 CFR 210 and 211), the
principles and guidelines specified in Chapter II of European Commission
Directive 91/356/Eed, including the rules governing medicinal products (in the
European Union Volume 4), policies or guidelines, in effect at any time during
the term of this Agreement, for the Production and testing of pharmaceutical
materials as applied solely to Products, and (b) the corresponding requirements
of each applicable Regulatory Authority.


 


1.12         “Delivery
Date” shall mean the date that Product is delivered to a common
carrier designated by AMYLIN.


 


1.13         “Effective
Date” shall mean the date of this Agreement as set forth above.


 


1.14         “Exenatide
Drug Substance” shall mean a
dry powder preparation containing exenatide peptide as provided by AMYLIN for
further manufacture or Production into Product by BAXTER


 


1.15         “FDA”
shall mean (a) the United States Food and Drug Administration or any successor
entity thereto and (b) the corresponding agency of each applicable Regulatory
Authority.


 


1.16         “FD&C
Act” shall mean the United States Federal Food, Drug and Cosmetic
Act, as may be amended from time to time, or such
similar statute in jurisdictions other than the United States.


 


1.17         “Long Range Forecast” shall be defined in
Section 4.1.


 


1.18         “Master
Batch Record” shall mean, with respect to each Presentation of
Product to be Produced hereunder, a formal set of
instructions and criteria for the Production of each Presentation of such
Product.


 


1.19         “NDA” shall
mean the FDA-required New Drug Application, and any amendments or supplements
thereto, or other applicable similar submissions to a Regulatory Authority.


 


1.20         “Presentation”
shall have the meaning set forth on Exhibit A.


 


1.21         “Produce”
or “Production” shall mean the
formulation, filling, packaging, inspecting, labeling,
and testing of Product by BAXTER.


 


1.22         “Product”
shall mean Exenatide BID or placebo in cartridges packaged in bulk as specified
in Exhibit A and the Project Plan and either Produced after the first


 





















 


Regulatory
Approval therefore or Produced as part of the Process Validation Batches,
provided regulatory approval is obtained which allow commercial sale of such
Process Validation Batches.


 


1.23         “Process
Validation Batches” shall
mean Exenatide BID in cartridges produced for the purposes of validating the
processing parameters for Production of Product produced pursuant to the terms
of the Development Agreement.  The
parties agree that the Product Produced in the Process Validation Batches may
be sold commercially provided regulatory approval is obtained which allows
commercial sale of such Process Validation Batches and that all the terms of
this Agreement, except Article 7, shall apply to the Product Produced in the
Process Validation Batches.


 


1.24         “Product
Specifications” shall mean with respect to each Product, the
analytical specifications and testing to be performed for the Exenatide Drug
Substance and the Product, in connection with release and/or stability testing
that are set forth in Product-specific standard
operating procedures and the Master Batch Records.  The Product Specifications include only those
tests that BAXTER is required to conduct or cause to be conducted as specified
in Exhibit C.  The Product Specifications
may be modified from time to time only by written agreement of AMYLIN and BAXTER.


 


1.25         “Product Requirements” shall mean the
Product Specifications, Master Batch Record, and the Project Plan.


 


1.26         “Project Plan” shall mean the manual
containing the parameters for the Production of each Presentation of
Product.  The Project Plan will be
prepared by BAXTER and agreed to in writing by AMYLIN.  In no event shall BAXTER be required to
schedule or commence the Production of the applicable Product unless and until
a Project Plan for such Presentation of Product has been approved in writing by
both parties.


 


1.27         “Purchase
Order” shall mean written orders from AMYLIN to BAXTER which shall
specify (a) the quantity of Product ordered, (b) shipping instructions, (c)
delivery dates, and (d) delivery destinations.


 


1.28         “Purchase
Price” shall mean the amount
to be paid by AMYLIN for Product as set forth in Exhibit B and as may be
amended from time to time by the parties pursuant to Section 5.3.


 


1.29         “Regulatory
Approval” shall mean all authorizations by the appropriate
Regulatory Authority necessary for commercial sale of Product in a
jurisdiction, including without limitation, approval of labeling, price,
reimbursement and production.


 


1.30         “Regulatory
Authority” shall mean the FDA in the United States, or the
applicable regulatory agency or entity having the responsibility, jurisdiction,
and


 





















 


authority to
approve the manufacture, use, importation, packaging, labeling, marketing, and
sale of Product in any jurisdiction other than the United States, as specified
in Exhibit E, as may be amended from time to time by mutual agreement of the
parties.


 


1.31         “Regulatory Plan” shall mean the manual containing the
regulatory services and support for the development and maintenance of
regulatory submissions and/or other filings, updates, or documentation required
by a Regulatory Authority to be performed by BAXTER, if requested by
AMYLIN.  The Regulatory Plan will be
prepared by BAXTER and agreed to in writing by AMYLIN.  BAXTER shall have no obligation to conduct
regulatory services for Product until the Regulatory Plan, if requested by
AMYLIN, for such Product has been approved in writing by both parties.


 


1.32         “Release” shall mean the delivery of the Released
Executed Batch Record to Amylin by Baxter.


 


1.33         “Released
Executed Batch Record” shall mean the completed batch record and
associated documentation as described in the Quality Agreement.


 


1.34         “Rolling Forecast” shall be defined in
Section 4.1.


 


1.35         “Unit”
shall mean an individually packaged dose of Product or placebo, as specified in
Exhibit A.


 


Article 2,  Reserved


 


Article 3, PURCHASE AND SUPPLY OF PRODUCT


 


3.1           Agreement to
Purchase and Supply.  Pursuant
to the terms and conditions of this Agreement, AMYLIN shall purchase from
BAXTER the Product, and BAXTER shall Produce and deliver to AMYLIN the Product
in accordance with Article 4 of this Agreement.


 


3.2           Reproduction, Rework or Reprocessing.  If during the Production of any Batch of
Product, any reprocessing, rework, or reproduction is required in order to meet
the Product Specifications, BAXTER shall conduct such reprocessing, rework, or
reproduction in compliance with the terms of the Quality Agreement, cGMPs, and
the NDA.  Any reprocessing, rework or
reproduction, and the related costs and expenses, must be approved in writing
by AMYLIN prior to implementation, such approval not to be unreasonably
withheld and/or delayed.  Re-packaging
and re-inspection are not considered reproduction, rework or reprocessing.  Unless such reprocessing, rework, or
reproduction is required as a result of the negligence or willful misconduct of
BAXTER, AMYLIN shall be responsible for, and promptly


 





















 


reimburse
BAXTER for, all costs and expenses incurred in connection with such
reprocessing, rework, or reproduction.


 


3.3           Exenatide
Drug Substance and AMYLIN Supplied Components.  AMYLIN, at its expense, shall deliver or
cause to be delivered, (a) a reasonably sufficient amount of Exenatide Drug
Substance and applicable certificate of analysis therefore and (b) all other
AMYLIN Supplied Components, if any, all to be delivered to BAXTER at least two
weeks (2) weeks in advance of the filling date set forth in Section 4.2.  Upon receipt of the AMYLIN Supplied
Components, if any, and Exenatide Drug Substance as set forth above, BAXTER’s
sole obligation with respect to evaluation of the AMYLIN Supplied Components
and Exenatide Drug Substance shall be to confirm, in accordance with the terms
of the Quality Agreement, that the Exenatide Drug Substance and AMYLIN Supplied
Components, if any, conform with the Product Specifications and Component
Specifications, respectively.  BAXTER
shall have no responsibility for delays in Release or delivery of Product
caused by delays in receipt of Exenatide Drug Substance or AMYLIN Supplied
Components. AMYLIN shall maintain at BAXTER the Exenatide Drug Substance and
AMYLIN Supplied Components in quantities sufficient to meet AMYLIN’s Purchase
Orders for Product and Rolling Forecast submitted by AMYLIN to BAXTER pursuant
to Article 4.  When AMYLIN is aware of an
expected delay in delivery of Exenatide Drug Substance or AMYLIN Supplied
Components, AMYLIN shall promptly notify BAXTER of such delay.


 


3.4           BAXTER
Supplied Components and Component Delivery Delays:  BAXTER will purchase the BAXTER Supplied
Components in quantities sufficient to meet AMYLIN’s Purchase Orders for
Product and Rolling Forecasts submitted by AMYLIN to BAXTER pursuant to Article
4.  BAXTER shall control such materials
and shall assist AMYLIN with evaluation and purchase of modified materials in
the event that AMYLIN requests a change in Presentation.  BAXTER shall not initiate any changes to
materials without written approval from AMYLIN. 
When BAXTER is aware of an expected delay in meeting AMYLIN’s Purchase
Order, BAXTER shall promptly notify AMYLIN of such delay.


 


3.5           Material
Safety Data Sheet.  AMYLIN shall
provide BAXTER a Material Safety Data Sheet for Exenatide Drug Substance and
for Product.  BAXTER shall immediately
notify AMYLIN of any unusual health or environmental occurrence relating to the
Product, including, but not limited to any claim or complaint by any employee
of BAXTER or any of its Affiliates or third party that the operations of BAXTER
pursuant to this Agreement have resulted in any adverse health or safety effect
on an employee or third party.  BAXTER
agrees to advise AMYLIN immediately of any safety or toxicity problems of which
it becomes aware regarding the Product.


 





















 


3.6           Importer
of Record.  In the event any material
or equipment to be supplied by AMYLIN, including without limitation AMYLIN Supplied
Components and Exenatide Drug Substance, is imported into the United States for
delivery to BAXTER (“Imported Goods”), such Imported Goods shall be imported
DDP Bloomington, IN (Incoterms 2000). 
AMYLIN shall be the “Importer of Record” of such Imported Goods.  As the Importer of Record, AMYLIN shall be
responsible for all aspects of the Imported Goods including, without limitation
(a) customs and other regulatory clearance of Imported Goods, (b) payment of
all tariffs, duties, customs, fees, expenses and charges payable in connection
with the importation and delivery of the Imported Goods, and (c) keeping all
records, documents, correspondence and tracking information required by
applicable laws, rules and regulations arising out of or in connection with the
importation or delivery of the Imported Goods.


 


3.7           Storage.


 


3.7.1           Product Storage.  BAXTER shall store Product free of charge for
[***] ([***]) calendar days after AMYLIN’s acceptance of Product pursuant to
Article 7 (the “Storage Period”).  Following
the Storage Period, BAXTER may continue to store Product at BAXTER for an
additional period of not more than [***] ([***]) months (the “Additional
Storage Period”) or at a third party facility in accordance with the terms of
Section 3.7.4. AMYLIN shall reimburse BAXTER for all costs incurred in
connection with such storage beyond the Storage Period pursuant to Exhibit
B.  If AMYLIN fails to provide approval
of a third party storage facility, pursuant to Section 3.7.4, within the
Additional Storage Period, AMYLIN shall take possession of the Product at such
time by providing BAXTER with shipping instructions.


 


3.7.2           Component Storage.  BAXTER shall be required to store such
supply of Components necessary to fulfill [***] ([***]) months of the Rolling
Forecast.


 


3.7.3           Exenatide Drug Substance Storage.  BAXTER shall not be required to store
quantities of Exenatide Drug Substance in excess of the capacity of AMYLIN’s
freezer(s) located at BAXTER.


 


3.7.4           Third Party Storage.  BAXTER shall be permitted to store Product
and Components in third party storage facilities, which are subject to audit
and prior written approval by AMYLIN pursuant to a mutually agreed upon Project
Plan.  BAXTER shall have no liability
for, and AMYLIN releases all claims against BAXTER arising out of any damage or
loss to Product or Components arising out of, or in connection with, the
storage in such third party facility, unless such claims are a result of the
negligence or willful misconduct of BAXTER. If AMLYN does not take possession
of Product prior to the expiration of the Additional Storage Period, Baxter may
store Product in a third party storage facility.  BAXTER will notify AMYLIN at least [***]
([***]) calendar days before moving Product to said third party storage
facility and AMYLIN will notify BAXTER within [***] ([***]) calendar days after
receipt


 










* Confidential Treatment Request(ed)


 





















 


of said notice
if AMYLIN does not want Product to be moved to the third party storage facility
and provide BAXTER alternate shipping instructions.  If BAXTER fails to hear from AMYLIN within
the [***] ([***]) day notice period, BAXTER may move Product to a third party
storage facility in accordance with the terms herein.


 


Article 4,  FORECASTS, ORDERS,
and CAPACITY


 


4.1           Forecasts
and Order Limits.


 


4.1.1        Commencing on the date of
this Agreement, and prior to October 1 of each year thereafter, AMYLIN will
provide to BAXTER in writing an annual forecast for each calendar year during
the remainder of the Term of AMYLIN’s estimated contract requirements for
Product (the “Long Range Forecast”).  The
annual forecast for the first full year of the Long Range Forecast shall be the
“Annual Forecast”.  Commencing on the
date of this Agreement and prior to each January 1, April 1, July 1 and October
1, of each year thereafter, AMYLIN will provide BAXTER in writing an [***]
rolling forecast of AMYLIN’s estimated contract requirements for Product by
Presentation (the “Rolling Forecast”). 
BAXTER specifically agrees that such Long Range Forecasts and Rolling
Forecasts submitted by AMYLIN will be for general planning purposes only, and
shall not be binding on AMYLIN or BAXTER, except as specified in Section 4.1.2.


 


4.1.2        During
each calendar quarter, BAXTER shall supply AMYLIN with the quantity of Product
ordered by AMYLIN, unless the quantity ordered in any calendar [***] exceeds
[***] percent ([***]%) of the quantity purchased in
the previous calendar [***], in which event BAXTER shall use good faith efforts
to supply quantities in excess of such amount. 
For each Rolling Forecast submitted by AMYLIN, in no event shall AMYLIN
purchase less than (a) [***] percent ([***]%) of the quantity forecasted by
Presentation for the [***] quarter of such Rolling Forecast, (b) [***] percent
([***]%) of the quantity of Product forecasted by Presentation for the [***]
quarter of such Rolling Forecast, and (c) [***] percent ([***]%) of the
quantity of Product forecasted by Presentation for the [***] quarter of such
Rolling Forecast (collectively, the “Minimum Quantity”).  Notwithstanding the foregoing, there shall be
no Minimum Quantity for the first calendar year after Regulatory Approval of
the Product in the United States.  In
each succeeding calendar [***], in the event AMYLIN purchases in any given
[***] less than the corresponding portion of the Minimum Quantity for said
[***] within [***] ([***]) days after the end of such [***] AMYLIN shall pay to
BAXTER the difference between the Purchase Price of Product actually purchased
and the Purchase Price of the


 










* Confidential Treatment Request(ed)


 





















 


 


corresponding
portion of the Minimum Quantity in said quarter, provided, however, AMYLIN
shall not be required to make any such payments to the extent AMYLIN has
submitted Purchase Orders for the Minimum Quantity and BAXTER confirmed such
Purchase Orders to be Firm Purchase Orders, but BAXTER was unable to deliver
such quantities of Product due to the negligence of BAXTER.  In
any given Rolling Forecast, (a) the quantity forecasted for the [***] of such Rolling Forecast shall not be less
than (a) [***] percent ([***]%) of the [***] forecast in the immediately preceding Rolling Forecast and (b) [***] percent ([***]%) of the [***]
forecast in the immediately preceding Rolling Forecast.


 


4.2           Purchase
Orders.  AMYLIN shall submit Purchase
Orders to BAXTER covering AMYLIN’s purchases of Product pursuant to this
Agreement.  AMYLIN shall not, without the
written consent of BAXTER, designate a delivery date in a Purchase Order
earlier than [***] ([***]) calendar days from the date AMYLIN submits the
Purchase Order.  Within ten (10) calendar
days of BAXTER’s receipt of the Purchase Order, BAXTER shall provide a
confirmation of receipt of each Purchase Order setting forth a Batch (or lot)
number (if available), the delivery date that BAXTER will meet and setting
forth BAXTER’s filling date for such order. 
Upon AMYLIN’s receipt of such confirmation, such Purchase Order shall
become a non-cancelable “Firm Purchase Order”, and AMYLIN shall be obligated to
purchase from BAXTER all Product ordered in a Firm Purchase Order.  If BAXTER is unable to meet the specified
delivery date BAXTER shall so notify AMYLIN and provide to AMYLIN an
alternative delivery date which shall not be more than [***] ([***]) calendar
days later than the initial delivery date designated by AMYLIN in its Purchase
Order; provided that the alternative delivery date is no longer than [***] and
[***] ([***]) calendar days from the issue of the AMYLIN Purchase Order.  To the extent of any conflict between
Purchase Orders submitted by AMYLIN and this Agreement, this Agreement shall
control.


 


4.3           Annual Obligation.  AMYLIN shall be obligated to purchase from
BAXTER a minimum number of Units of such Product in each calendar year during
the Term of this Agreement as specified in Exhibit F (the “Annual Obligation”),
which Annual Obligation shall be pro rated for any partial calendar year.  Within [***] ([***]) days after the end of
each calendar year, AMLYIN shall pay to BAXTER the difference between the
Purchase Price of the Product actually purchased pursuant to Sections 4.1 and
4.2 by AMYLIN and the Purchase Price of the Annual Obligation of the
Product.  BAXTER specifically agrees
there shall be no Annual Obligation for the first calendar year after
Regulatory Approval in the United States.


 


4.4           Annual Order
Increases.  In any calendar year after the first calendar
year and during the Term of this Agreement, in no event shall BAXTER be
obligated to Produce more than the lesser of (a) the greater of (i) [***] percent ([***]%) of the


 










* Confidential Treatment Request(ed)


 





















 


quantity of Product Produced by BAXTER in the preceding calendar year
or (ii) [***] ([***]) Units in excess of the quantity of Product Produced by
BAXTER in the preceding calendar year, and (b) [***] ([***]) Units of Product;
provided, however, BAXTER will use good faith efforts to meet such increased
demand.


 


Article 5,  PRICE


 


5.1           Regulatory Services Price.  The price to be
paid by AMYLIN for regulatory services shall be set forth in Exhibit B.


 


5.2           Product Purchase
Price.  The Purchase Price
will be fixed for the Initial Term (as hereinafter defined) of this Agreement
as specified in Exhibit B.  The Purchase
Price for Product for each calendar year will be the price specified in Exhibit
B corresponding to the annual volume which is the greater of (a) [***] percent ([***]%) of the Annual Forecast or (b) the Annual Obligation for
such calendar year. AMYLIN shall pay the Purchase Price as determined above for
all Product, including Units accepted by AMYLIN pursuant to Article 7 samples
consumed by BAXTER for release testing, samples shipped for AMYLIN release and
stability testing, and any retention samples; except as provided for in Article
7.  In the event AMYLIN requests a change
in scope for Production of Product or Regulatory Authority associated with the
Production, BAXTER may adjust the Purchase Price for Product or for a
particular Presentation of Product as set forth in a revision to Exhibit B as
mutually agreed to by the parties.


 


5.3           Purchase
Price Adjustment.  Upon
expiration of the Initial Term or any extension thereof, BAXTER may adjust the
Purchase Price of Product to reflect changes in the cost of materials provided
by BAXTER, labor costs paid by BAXTER in connection with the Production of such
Product, improvements in the manufacturing process, and any other
improvements.  Following the first year
of Regulatory Approval, AMYLIN and BAXTER agree to meet no less than [***] per calendar year to formally
review continuous improvement activities and other improvements resulting from
experience in operating the new process. AMYLIN and BAXTER shall work together
to obtain process improvements and any net cost savings achieved by the parties
shall be [***], after taking
into account any necessary [***]
or [***] costs related to the
process improvements and any current [***]
and [***] cost increases.  [***]
calendar quarters prior to expiration of the Initial Term or any extension
thereof, BAXTER shall provide to AMYLIN notification of such Purchase Price
adjustment.  If the parties cannot in
good faith agree on the proposed Purchase Price adjustment, the dispute will be
discussed between the senior management of both AMYLIN and BAXTER.  In no event may BAXTER increase the Purchase
Price following the Initial Term by a percent which exceeds the lesser of (i)
the percentage change in the [***]
([***]) for the


 










* Confidential Treatment Request(ed)


 





















 


previous [***] ([***]) months or (ii) [***]
percent ([***]%) of the original
Purchase Price.


 


5.4           Inventory Levels.  At the end of each calendar year, the parties
will review the inventory levels of Components purchased by BAXTER pursuant to
AMYLIN’s Rolling Forecast.  In the event
AMYLIN fails to consume pursuant to AMYLIN’s Firm Purchase Orders [***] percent ([***]%) of the Components purchased by BAXTER, AMYLIN shall pay to
BAXTER the costs of such Components purchased by BAXTER and not consumed by
AMYLIN.  The amount of such payments will
be deducted from the Purchase Price of Product purchased by AMYLIN after BAXTER’s
receipt of such payments until such time as all such paid-up Components have
been consumed.


 


5.5           Yield Requirement. 
Following the Production of (a) the [***] ([***])
process validation Batches of each Presentation of Product and (b) the initial
[***] ([***]) post-process validation Batches of each Presentation of
Product (the “Yield Batches”) the parties will determine the expected yield (“EY”)
for each Presentation of Product, which EY shall be equal to the [***] by Presentation resulting from
the Yield Batches less [***].  If there is a manufacturing anomaly in one or
more of the Yield Batches, the parties may agree to eliminate such Batch from
the EY calculation or may require an additional Batch be included.  In the event Baxter fails to meet such EY on average
for Batches Produced in the first quarter after which EY was determined,
provided such Presentation of Product was Produced in such quarter, BAXTER will
deliver on average during any calendar quarter thereafter not less than such
mutually agreed upon EY for each Presentation of Product for all Batches
Released during such quarter, provided a minimum of [***] ([***]) such
Batches have been Released for each Presentation, including all Units Released
by BAXTER, samples consumed by BAXTER for release testing, samples shipped for
AMYLIN release and stability testing, and any retention samples.  If [***]
([***]) Batches of each
Presentation of Product were not Released in such calendar quarter, the
reconciliation process described herein will be performed when the [***] ([***]) such Batch, following the most recent reconciliation, is
Released and invoiced by BAXTER.  In the
event that BAXTER delivers, on average, an actual yield (“AY”) for Batches
Released in any calendar quarter which is lower than EY set out above, at the
end of such calendar quarter, Baxter will reimburse AMYLIN according to the
following formula:


[***];


provided, however, such amount shall not exceed [***] percent ([***]%) of the Purchase Price of such Presentation of Product purchased
by AMYLIN in such calendar quarter, or applicable time period.  If the actual yield is low due to additional
sampling, testing, technical transfer, stability, or AMYLIN requested samples
for a given Batch, such Batch will not be included in the quarterly calculation
and BAXTER will not reimburse AMYLIN for such deficit.  The


 










* Confidential Treatment Request(ed)


 





















 


foregoing represents the sole liability of BAXTER and the sole and
exclusive remedy of AMYLIN for yield shortfall.


 


5.6           Loss of Exenatide Drug
Substance.  If any lot of Exenatide Drug Substance is
destroyed, damaged or lost while in BAXTER’s custody, control or storage unless
such destruction, damage or loss was outside of the reasonable control of
BAXTER, BAXTER shall reimburse AMYLIN for its actual out-of-pocket costs for
the Exenatide Drug Substance, provided such reimbursement shall not exceed [***] percent ([***]%) of the Purchase Price of a Batch of
Product that would have been Produced from such Batch or lot of Exenatide Drug
Substance, and AMYLIN shall not be responsible for payment of the Purchase
Price to BAXTER for any Batch that would have been produced for such Exenatide
Drug Substance.  The foregoing
represents the sole liability of BAXTER and the sole and exclusive remedy of AMYLIN
for the loss of a Batch or Exenatide Drug Substance except as set forth in
Article 7.


 


5.7           Effects of Certain Events.  In addition to the costs and expenses payable
in Section 8.7, in the event of termination of this Agreement, except by AMYLIN
as a result of a breach by BAXTER under Section 8.2 or by AMYLIN pursuant to
Sections 8.3 or 8.5, AMYLIN shall pay BAXTER as liquidated damages and not as a
penalty an amount equal to[***]
percent ([***]%) of the greater
of the Annual Obligation or the Rolling Forecast prorated for the next [***] ([***]) months.


 


Article
6,  SHIPMENT AND INVOICING


 


6.1           Delivery Terms. 
Product shall be delivered to AMYLIN, or to a location designated by
AMYLIN in the Purchase Order, EXW (Incoterms, 2000) BAXTER’s facility in Bloomington,
Indiana freight collect, by a common carrier designated by AMYLIN in the
Purchase Order, at AMYLIN’s expense; provided, however, BAXTER shall be
responsible for the loading of the Product on departure and shall bear all
costs of such loading. AMYLIN shall procure, at its cost, insurance covering
damage or loss to the Product during shipping.


 


6.2           Exporter of Record.  AMYLIN or its Collaboration Partner shall be
the exporter of record for any Product shipped out of the United States, as
AMYLIN or its Collaboration Partner remains the owner of the Product.  AMYLIN or Collaboration Partner warrants that
all shipments of Product exported from the United States will be made in
compliance with all applicable United States export laws and regulations and all
applicable import laws and regulations into the country of importation.


 


AMYLIN or its
Collaboration Partner shall be responsible for obtaining and paying for any
licenses or other governmental authorization(s) necessary for the exportation
from the United States.  AMYLIN or its
Collaboration Partner shall


 










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select and pay
the freight forwarder who shall solely be AMYLIN’s or its Collaboration Partner’s
agent.  AMYLIN or its Collaboration
Partner’s and its freight forwarder shall be solely responsible for preparing
and filing the Shipper’s Export Declaration and any other documentation
required for the export.


 


6.3           Foreign Corrupt Practices Act.  AMYLIN acknowledges it is not the agent of
BAXTER and represents and warrants that it has not, and covenants that it will
not, pay anything of value to any government employee in connection with the
resale of the Product.


 


6.4           Payment
Terms.  The following
invoicing and payment terms apply:


 


	
  Status

  	
   

  	
  Invoice Date

  	
   

  	
  Payment Due

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Commercial Production

  	
   

  	
  BAXTER’s Release

  of Batch Record

  	
   

  	
  Invoice Date + [***]
  days

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Regulatory Services

  	
   

  	
  Monthly

  	
   

  	
  Invoice Date + [***]
  days

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Article 8 Payments

  	
   

  	
  Upon notice

  	
   

  	
  Invoice Date + [***]
  days

  



 


For the avoidance of doubt, the process validation Batches will be manufactured
under the Drug Product Development Agreement dated February 27, 2004 and will
be billed according to the terms contained therein.


 


Payments shall be made in U.S. dollars by check delivered to BAXTER by
overnight delivery with a reputable overnight delivery service.  Each invoice shall be payable by AMYLIN in
accordance with the terms noted above. 
Any payment due under this Agreement not received within the times noted
above shall bear interest at the lesser of (a) the maximum rate permitted by
law, or (b) [***]% per month on
the outstanding balance compounded [***].


 


6.5           Default in Payment Obligations.  In addition to all other remedies available
to BAXTER in the event of a AMYLIN default, if AMYLIN fails to make payments as
required hereunder within thirty calendar days of notice of such failure to
make payments, BAXTER may refuse all further Purchase Orders or refuse to
Produce any Product until AMYLIN’s account is paid in full, place the account
on a letter of credit basis, require full or partial payment in advance and/or
suspend deliveries of Product until AMYLIN provides assurance of performance
reasonably satisfactory to BAXTER.


 










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Article
7,  ACCEPTANCE OF PRODUCT


 


7.1           Product
Conformity.  Within [***] ([***]) days from the date of receipt by AMYLIN of samples of
Product or [***] ([***]) calendar days from the date of
receipt by AMYLIN of the Released Executed Batch Record to AMYLIN, whichever is
later, AMYLIN shall determine whether such Batch conforms to the Product
Requirements.


 


7.1.1        If AMYLIN fails to notify
BAXTER within the applicable time period as specified in Section 7.1, that any
Batch does not conform to the Product Requirements, then AMYLIN shall be deemed
to have accepted the Batch and waived its right to revoke acceptance.


 


7.1.2        If AMYLIN believes any
Batch does not conform to the Product Requirements, it shall notify BAXTER by
telephone including a detailed explanation of the non-conformity and shall
confirm such notice in writing via overnight delivery to BAXTER.  Upon receipt of such notice, BAXTER, in
accordance with the terms of the Quality Agreement, will investigate such
alleged non-conformity, and (i) if BAXTER agrees such Batch is non-conforming,
deliver to AMYLIN a corrective action plan within [***] ([***])
calendar days after receipt of AMYLIN’s written notice of non-conformity, or
such additional time as is reasonably required if such investigation or plan
requires data from sources other than AMYLIN or BAXTER, or (ii) if BAXTER
disagrees with AMYLIN’s determination that the Batch is non-conforming, BAXTER
shall so notify AMYLIN by telephone within the [***] ([***])
calendar day period and confirm such notice in writing by overnight delivery.


 


7.1.3        If the parties dispute
whether a Batch is conforming or non-conforming, the shipment of Product will
be submitted to a mutually acceptable laboratory or consultant for resolution,
whose determination of conformity or non-conformity, and the cause thereof if
non-conforming, shall be binding upon the parties.


 


7.2           Remedies for Non Conforming Product.


 


7.2.1        In the event BAXTER agrees
that a Batch is non-conforming or the laboratory determines that a Batch is
non-conforming, BAXTER shall provide replacement Product for such
non-conforming Batch which shall be Released by BAXTER within the latter of (a)
[***] ([***]) calendar days from receipt of replacement Exenatide Drug
Substance from AMYLIN or (b) [***]
([***]) calendar days from the
date of determination by the third party of non-conformity or agreement by
BAXTER of such non-conformity.


 










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7.2.2        AMYLIN shall pay for all Product, including replacement Product and the cost of
Exenatide Drug Substance therefore, except as specifically set forth in Section
7.2.3.


 


7.2.3        In the event BAXTER
agrees, or the laboratory or consultant determines, that a Batch is
non-conforming, solely as a result of the negligence or willful misconduct of
BAXTER, AMYLIN shall not be required to pay for such Batch, BAXTER shall
provide replacement Product as specified in Section 7.2.1., shall reimburse
AMYLIN for its actual cost of the Exenatide Drug Substance for the
non-conforming Batch, which cost shall not exceed [***] percent ([***]%)
of the Purchase Price for Units comprising the non-conforming Batch of Product,
and shall bear the costs of such laboratory or consultant and any storage fees
incurred by AMYLIN for the non-conforming Batch.  The foregoing shall be AMYLIN’s sole and exclusive
remedy and BAXTER’s sole liability for replacement of conforming Product.


 


7.3      Latent
Defect:  If, within [***] ([***]) days after AMYLIN’s
acceptance of a Batch, AMYLIN discovers a latent defect such as a Contaminant
in such Batch that existed in the Batch on or before AMYLIN’s acceptance of the
Batch, AMYLIN shall notify BAXTER immediately of such discovery, and AMYLIN
shall have the right to reject such Batch under the procedures regarding
rejection set forth in Section 7.1 and 7.2 above, provided however, if BAXTER
disagrees with AMYLIN’s determination that a latent defect exists or that the
latent defect existed in the Batch on or before AMYLIN’s acceptance of the
Batch, then BAXTER shall so notify AMYLIN within [***] ([***]) days after
receiving AMYLIN’s notification about the latent defect, and in such cases,
samples of the Batch of Product will be submitted to a mutually acceptable
laboratory or consultant for resolution, whose determination of conformity or
non-conformity, and the cause thereof if non-conforming, shall be binding upon
the parties.  AMYLIN shall bear the costs
of such laboratory or consultant, unless the laboratory or consultant
determines that the non-conformance is due to the negligence or willful
misconduct of BAXTER in which event BAXTER shall bear the costs of such
laboratory or consultant.


 


7.4      Non-conforming
Exenatide Drug Substance.  If
Product is rejected by AMYLIN, and such Product’s failure to meet the Product
Requirements is the result of non-conforming Exenatide Drug Substance, then
BAXTER shall not bear any liability under this Article 7.


 


Article 8,  TERM AND TERMINATION


 


8.1           Initial Term.  This
Agreement shall be effective on the Effective Date and shall continue for sixty
(60) months thereafter  (the “Initial Term”),
unless earlier


 










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terminated in accordance with the terms of this Agreement.  This Agreement will be renewed automatically
for one (1) additional twenty-four (24) month period commencing at the
expiration of the Initial Term and any extensions thereof unless either AMYLIN
or BAXTER terminates the Agreement by giving the other party written notice of
intent to terminate at least twenty-four (24) months prior to the expiration of
the Initial Term or any extension thereof. 
The Initial Term as may be extended is referred to herein as the “Term.”


 


8.2           Termination for Breach. 
Either party may terminate this Agreement upon the breach of any
provision of this Agreement by the other party if such breach is not cured by the
breaching party within fifteen (15) calendar days for monetary defaults, and
thirty (30) calendar days for non-monetary defaults (or such additional time
reasonably necessary to cure such non-monetary default provided the breaching
party has commenced a cure within the thirty (30) day period and is diligently
pursuing completion of such cure) after receipt by the breaching party of
written notice of such default.  At the
option of the non-breaching party, such termination may be with respect to the
entire Agreement, or only with respect to the Product which is the subject of
the breach.


 


8.3           Termination
for Financial Matters.  This
Agreement may be terminated immediately by either party by giving the other
party written notice thereof in the event such other party makes a general
assignment for the benefit of its creditors, or proceedings of a case are
commenced in any court of competent jurisdiction by or against such party
seeking (a) such party’s reorganization, liquidation, dissolution, arrangement
or winding up, or the composition or readjustment of its debts, (b) the
appointment of a receiver or trustee for or over such party’s property, or (c)
similar relief in respect of such party under any law relating to bankruptcy,
insolvency, reorganization, winding up or composition or adjustment of debt,
and such proceedings shall continue undismissed, or an order with respect to
the foregoing shall be entered and continue unstated, for a period of more than
sixty (60) days.


 


8.4           Termination
Related to AMYLIN Regulatory Status. 
AMYLIN may immediately terminate this Agreement by giving written notice
to BAXTER, including a certification as to the grounds for termination signed
by the chief regulatory officer of AMYLIN and/or a copy of the relevant
Regulatory Authority notice(s), if any Regulatory Authority (a) denies approval
of Exenatide, (b) withdraws approval of Exenatide, or (c) does not approve
BAXTER as a manufacturer of Product within eighteen (18) months after
Regulatory Approval.


 


8.5           Termination Related to Regulatory Compliance.  AMYLIN may
terminate this Agreement by giving ninety (90) days written notice to BAXTER if
BAXTER (i) has its manufacturing authorizations for Product suspended or
withheld; (ii) in the case of a PAI for Product, fails to pass an inspection by
a Regulatory Authority due to an act or omission of BAXTER; or (iii) in the
case of a regulatory


 





















 


inspection
(which directly relates to or directly impacts Product) by a Regulatory
Authority fails to pass an inspection and has not completed the corrective
action(s) agreed upon with the Regulatory Authority within the time period
agreed upon with such Regulatory Authority, unless otherwise agreed by BAXTER
and either AMYLIN (for a United States Regulatory Authority) or Collaboration
Partner (for all Regulatory Authorities outside the United States).  BAXTER may terminate this Agreement by giving
ninety (90) days written notice to AMYLIN if AMYLIN, with respect to Exenatide
Drug Substance (a) has its manufacturing authorizations suspended or withheld;
(b) in the case of a PAI, fails to pass an inspection by a Regulatory Authority
due to an act or omission of Amylin; or (c) in the case of a regulatory
inspection (which directly relates to or directly impacts Exenatide Drug
Substance) by a Regulatory Authority fails to pass an inspection and has not
completed the corrective action(s) agreed upon with the Regulatory Authority
within the time period agreed upon with such Regulatory Authority, unless
otherwise agreed by BAXTER and AMYLIN.


 


8.6           Additional
Rights and Remedies.  Subject
to Section 13.1, termination under this Article 8 shall be in addition to the
other rights and remedies of the terminating party.  Unless otherwise provided herein, termination
of this Agreement for any reason shall not relieve any party of any obligations
accruing prior to such termination.


 


8.7           Non-cancelable
Costs and Expenses.  In the
event of the termination or cancellation of this Agreement, except by AMYLIN as
a result of a breach by BAXTER under Section 8.2 or by AMLYIN pursuant to
Section 8.3 or 8.5, AMYLIN shall (a) reimburse BAXTER for all actual
out-of-pocket expenses incurred or accrued for all Components ordered prior to
termination and not reasonably usable by BAXTER within six (6) months of
termination not cancelable at no or reduced costs to BAXTER and (b) pay BAXTER
for any work in process or finished goods pursuant to any outstanding Firm
Purchase Orders.  In addition, in the
event of termination or cancellation for any reason other than termination by
AMYLIN pursuant to Sections 8.3 or 8.5, AMYLIN shall pay prices described in
Article 5 for (i) all work-in-process commenced by BAXTER and (ii) all finished
goods of BAXTER.  BAXTER shall ship such
materials to AMYLIN pursuant to Section 6.1. 
AMYLIN shall make payment for all expenses described in this Section 8.6
forty-five (45) calendar days from the invoice date.


 


8.8           Survival.  Termination, expiration, cancellation or
abandonment of this Agreement through any means or for any reason, except as
set forth in Section 13.1, shall be without prejudice to the rights and
remedies of either party with respect to any of the provisions of this
Agreement.  The provisions of Sections
12, 13, 14, 15, 16, 17 and 18 hereof shall survive expiration or termination of
this Agreement.


 





















 


Article 9,  PRODUCTION OF PRODUCT


 


9.1           Production.  BAXTER
shall Produce Product in accordance with cGMP and Product Specifications.
Subject to compliance with reasonable rules and regulations of BAXTER, AMYLIN
and its Collaboration Partner shall have the right to be present during
Production for observational purposes only and according to BAXTER’s
policies.  Production deviations and
investigations which occur during Production of Product and which do not cause
the Production to be non-compliant with either cGMP or Product Specifications
shall not be deemed to cause such Product to be non-conforming.  BAXTER will provide AMYLIN notice, in the
event BAXTER is unable to supply Product.


 


9.2           Audits.  AMYLIN and
its Collaboration Partner shall have the right to audit BAXTER’s facilities to
determine compliance with (a) cGMP and (b) applicable federal, state, and local
laws, regulations and rules.  Such audits
shall be scheduled at mutually agreeable times upon reasonable advance written
notice to BAXTER, and (a) shall be at AMYLIN’s expense, and (b) shall not occur
more than one (1) time per calendar year, in either case unless related to
BAXTER’s compliance status or AMYLIN’s or its Collaboration Partner’s
obligations as a license holder.  If
AMYLIN requests additional audits which are not due the reasons stated above
and BAXTER agrees to such audits, AMYLIN will incur fees as set forth on
Exhibit B.  Such fees shall be paid
promptly upon completion of such audits. 
AMYLIN may request an additional follow-up audit, at no charge to
AMYLIN, if any audit determines that BAXTER is not in compliance with the above
requirements for the primary purpose of confirming that appropriate corrective
actions have been implemented. In connection with performing such audits,
AMYLIN or its Collaboration Partner shall comply with all reasonable rules and
regulations promulgated by BAXTER.  All
information disclosed or reviewed in such inspections shall be deemed to be the
property of BAXTER and BAXTER Confidential Information.  For purposes of clarity, a site visit, the
primary purpose of which is for business or technical discussions, shall not be
considered an audit under this Section 9.2. 
AMYLIN shall have the right to conduct a physical inventory audit of its
inventory at BAXTER’s facilities, at AMYLIN’s expense, once per year.  Such physical inventory audit does not count
as AMYLIN’s annual audit as described in this Section.


 


9.3           Testing.  BAXTER shall
test, or cause to be tested by third party testing facilities as directed by
AMYLIN or its Collaboration Partner, in accordance with the Product
Specifications, samples of each Batch of Product Produced pursuant to this
Agreement before delivery to AMYLIN. 
Samples of each Batch are to be delivered to AMYLIN or AMYLIN’s designee
within [***] ([***]) calendar days of completion of
filling of such Batch. A certificate of analysis for each Batch of Product
delivered to AMYLIN shall set forth the items tested by BAXTER, specifications,
and test results.  BAXTER shall send, or
cause to be sent, such certificates along with one (1) copy of the Released
Executed Batch Record and


 










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associated documentation described in the Quality Agreement to AMYLIN
prior to or at the same time of shipment of Product to AMYLIN and within thirty
days from the completion date of capping if such Batch requires no
investigations and/or additional testing. 
As required by the FDA and Regulatory Authorities, AMYLIN shall assume
full responsibility for final release of each lot of the Product.


 


9.4           Stability Testing.  At
AMYLIN’s cost and expense, AMYLIN or a party selected by AMYLIN shall perform
all stability testing required to be performed on Batches of Product.  If performed by BAXTER, such testing shall be
performed in accordance with the procedures set out in the Product-specific
protocols agreed to between AMYLIN and BAXTER.


 


9.5           Permits and Licenses. 
AMYLIN or its Collaboration Partner shall have sole responsibility, at
its expense, for obtaining all permits and licenses necessary or required for
the sale, marketing and commercialization of each Product Produced by BAXTER
hereunder.  BAXTER shall be responsible,
at its expense, to obtain and maintain all permits and licenses required for it
to carry out its development, regulatory and Production obligations hereunder.


 


9.6           Regulatory Requirements. 
Each party shall promptly notify the other of new regulatory
requirements of which it becomes aware which are relevant to the Production of
a Product under this Agreement and which are required by the FDA, any other
applicable Regulatory Authority or other applicable laws or governmental
regulations, and shall confer with each other with respect to the best means to
comply with such requirements.


 


9.7           Drug Master
File.  BAXTER shall file and
maintain the appropriate Drug Master File (“DMF”) and related reference
applications (e.g. Site Master File) for its Production of each Product
hereunder in accordance with 21 CFR 314.420, as may be amended from time to
time, and other regulatory requirements or required by Regulatory Authorities
at BAXTER’s expense.


 


9.8           Customer
Complaints and Adverse Events: AMYLIN or its Collaboration Partner,
as required by the applicable Regulatory Authority which granted Regulatory
Approval, shall maintain all customer complaint and adverse event files.  Any such complaints received by BAXTER shall
be forwarded to AMYLIN, which shall forward appropriate complaints or adverse
event files to its Collaboration Partner. 
AMYLIN or its Collaboration Partner shall be responsible for the review
of the complaint or adverse event to determine the need for an investigation or
the need to report to the applicable Regulatory Authority as required.  AMYLIN and its Collaboration Partner shall send
to BAXTER all Product performance or manufacturing-related complaints which
require investigation and shall provide to BAXTER Product which is the subject
of such complaints in accordance with the


 





















 


Quality Agreement.  If BAXTER
receives such returned samples, BAXTER shall conduct an investigation for each
Product performance or manufacturing-related complaint and shall report
findings and follow-up of each investigation to AMYLIN at no cost to AMYLIN,
which shall forward appropriate findings to its Collaboration Partner.  AMYLIN or its Collaboration Partner shall
make these complaint files available to BAXTER in the event they are required
during an inspection by a Regulatory Authority. 
Typical timelines are five (5) calendar days for notification and
twenty-eight (28) calendar days for completion of investigations.


 


9.9           Changes in
Manufacturing:


 


9.9.1        Changes to Master Batch Records and Product Specifications.  BAXTER shall notify AMYLIN of and require
written approval from AMYLIN for changes to Master Batch Records and Product
Specifications prior to the Production of subsequent Batches of Product.


 


9.9.2        Product-Specific Changes. 
If facility, equipment, process or system changes are required of BAXTER
as a result of requirements set forth by the FDA or any other Regulatory
Authority, and such regulatory changes apply solely to the Production and
supply of Product, then AMYLIN and BAXTER will review such requirements and
agree in writing to such regulatory changes, and AMYLIN shall bear [***]% of the
reasonable costs thereof.


 


9.9.3        General Changes.  If
such regulatory changes apply generally Product as well as to other products
produced by BAXTER for itself or for third parties, then BAXTER shall pay [***] percent ([***]%) of the reasonable cost of such regulatory changes.


 


9.10         Equipment
Expenses.  If BAXTER is
required to obtain specialized equipment in response to a request by AMYLIN in
order to Produce Product for AMYLIN, the costs of such equipment shall be paid
by AMYLIN provided however, BAXTER must obtain prior written approval from
AMYLIN before making such purchases. 
BAXTER shall advise AMYLIN of the specialized equipment required and the
estimated costs associated with the purchase and installation of such
equipment.  If AMYLIN, in its sole
discretion, determines that it does not desire to pay the costs for such
equipment, then AMYLIN shall have the right to terminate this Agreement with
respect to such Product for which such equipment is required only, on ninety
(90) days prior written notice to BAXTER. 
AMYLIN shall be invoiced for all approved costs after installation and
acceptance of such equipment by BAXTER, and AMYLIN shall make payments within
thirty (30) days of the date of invoice from BAXTER.


 










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9.11         Ownership of
Equipment.  Upon termination
or expiration of this Agreement, BAXTER, at AMYLIN’s option shall either (i)
transfer possession of the specialized equipment paid for by AMYLIN to AMYLIN,
or (ii) with the consent of BAXTER, which such consent shall not be
unreasonably withheld or delayed, purchase such equipment by paying AMYLIN the
then current book value of such equipment. 
Depreciation of such equipment shall be calculated in accordance with general
accepted accounting principals.


 


Article 10,  REGULATORY


 


10.1         Regulatory Approvals. 
AMYLIN or its Collaboration Partner will use commercially reasonable
efforts to obtain Regulatory Approval of marketing licenses for Product
Produced by BAXTER hereunder.  AMYLIN or
its Collaboration Partner will advise BAXTER of document requirements in
support of NDA and similar applications required of foreign governments and
agencies including amendments, license applications, supplements and
maintenance of such.  BAXTER will provide
documents and assist AMYLIN or its Collaboration Partner in preparation of
submissions to Regulatory Authorities (both U.S and foreign) designated by
AMYLIN or its Collaboration Partner in support of AMYLIN’s NDAs and its
Collaboration Partner’s similar applications required of foreign governments
and licenses.  All regulatory submission
preparation and maintenance performed by BAXTER for AMYLIN or its Collaboration
Partner shall be specified in the Regulatory Plan.  Prior to submission to a Regulatory Authority
mutually agreed to, AMYLIN or Collaboration Partner will provide BAXTER with a
copy of the appropriate parts of the CMC section for review and comment as
mutually agreed between the parties.  A
final copy of the appropriate parts of the CMC section will be provided by
AMYLIN or Collaboration Partner to BAXTER upon submission to the Regulatory
Authority.  AMYLIN shall notify BPS
within three (3) business days of receipt of an approvable letter.  Upon Regulatory Approval, AMYLIN or
Collaboration Partner will notify BAXTER within three (3) business days of such
approval.


 


10.2         Regulatory
Authority Inspections.  At
AMYLIN’s or its Collaboration Partner’s request, BAXTER will authorize
Regulatory Authorities to review related applications on AMYLIN’s or its
Collaboration Partner’s behalf.  BAXTER
will notify AMYLIN and its Collaboration Partner within two (2) business days
of all contacts with Regulatory Authorities (both written and verbal) related
to Product.  BAXTER shall inform AMYLIN
and its Collaboration Partner of the result of any regulatory inspection which
affects the Production of Product, including any notice of inspection, notice
of violation or other similar notice received by BAXTER affecting Production,
testing, storage or handling of Product. 
In the event of an FDA or other Regulatory Authority inspection which
directly involves a Product, AMYLIN and its Collaboration Partner shall be
immediately informed of the issuance of the notice of inspection within (1)
business day by telephone


 





















 


and within two
(2) business days in writing or electronically. 
In the event that there are inspectional observations, AMYLIN or its
Collaboration Partner shall be informed immediately, within (1) calendar day by
telephone and within two (2) calendar days in writing or electronically and
shall have the opportunity to review and provide BAXTER with comments to BAXTER’s
response.  AMYLIN and its Collaboration
Partner shall provide its comments to the response of these observations within
five (5) calendar days.  The contents of
BAXTER’s response shall be determined by BAXTER in its sole discretion.


 


Article 11,  TRADEMARKS


 


11.1         AMYLIN
grants to BAXTER a non-exclusive, royalty free license to use the AMYLIN
Trademarks for the sole purpose of allowing BAXTER to fulfill its responsibilities
under this Agreement.  Such license shall
not be transferable in whole or in part.


 


11.2         AMYLIN
shall be solely responsible for selecting, registering and enforcing the AMYLIN
Trademarks used to identify the Product and except as set forth in Section 11.1
and shall have sole and exclusive rights in such AMYLIN Trademarks.


 


Article 12,  REPRESENTATIONS AND
WARRANTIES


 


12.1         Mutual Representations. 
Each party hereby represents and warrants to the other party that (a)
the person executing this Agreement is authorized to execute this Agreement;
(b) this Agreement is legal and valid and the obligations binding upon such
party are enforceable by their terms; and (c) the execution, delivery and
performance of this Agreement does not conflict with any agreement, instrument
or understanding, oral or written, to which such party may be bound, nor
violate any law or regulation of any court, governmental body or administrative
or other agency having jurisdiction over it.


 


12.2         BAXTER Warranty. 
BAXTER represents and warrants that Product shall be Produced in
accordance with Product Requirements. 
BAXTER warrants that at the time of Release the Product shall not be
adulterated within the meaning of the FD&C Act.  BAXTER represents and warrants that it has
obtained (or will obtain prior to Producing Product), and will remain in
compliance with during the term of this Agreement, (i) all permits, licenses
and other authorizations (the “Permits”) which are required under federal,
state and local laws, rules and regulations applicable to the production of
products generally and (ii) all Permits applicable to the Production of
Product; provided, however, BAXTER shall have no obligation to obtain Permits
relating to the sale, marketing, distribution or use of Exenatide Drug
Substance or Product or with respect to the labeling of


 





















 


Product.  BAXTER makes no
representation or warranty with respect to the sale, marketing, distribution or
use of the Exenatide Drug Substance or as to printed materials specified by
AMYLIN or its consignee.


 


12.3         Disclaimer of Warranties. 
Except for those warranties set forth in Sections 12.1 and 12.2 of this
Agreement, BAXTER makes no warranties, written, oral, express or implied, with
respect to Product or the Production of Product.  ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY
BAXTER.  NO WARRANTIES OF BAXTER MAY BE
CHANGED BY ANY REPRESENTATIVES OF BAXTER. 
AMYLIN accepts Product subject to the terms hereof.


 


12.4         AMYLIN Warranties. 
AMYLIN warrants that (a) it has the right to give BAXTER any information
provided by AMYLIN hereunder, and that BAXTER has the right to use such
information for the Production of Product, and (b) AMYLIN has no knowledge of
any (i) patents or other intellectual rights that would be infringed by BAXTER’s
Production of Product under this Agreement, or (ii) proprietary rights of third
parties which would be violated by BAXTER’s performance hereunder.  AMYLIN further warrants that the Exenatide
Drug Substance provided to BAXTER hereunder will (1) conform to the Exenatide
Drug Substance specifications as listed in Exhibit D and (2) not be adulterated
or misbranded within the meaning of the FD&C Act.


 


Article 13,  LIMITATION OF
LIABILITY AND WAIVER OF SUBROGATION


 


13.1         Limitation of Liability. 
AMYLIN’s sole and exclusive remedies for non-conforming Product are
limited to those remedies set forth in Article 7.  Under no circumstances shall BAXTER or AMYLIN
be liable for loss of use or profits or other collateral, special,
consequential or other damages, losses, or expenses, including but not limited
to the cost of cover or the cost of a recall, except as specifically set forth
in Article 16, in connection with or by reason of the Production and delivery
of Product under this Agreement whether such claims are founded in tort or
contract.


 


13.2         Waiver of Subrogation. 
All BAXTER Supplied Components, equipment used by BAXTER in the
Production of Product, and Product stored by BAXTER (collectively, “BAXTER
Property”) shall at all times remain the property of BAXTER and BAXTER assumes
risk of loss for Baxter Property up to and including the Storage Period and the
Additional Storage Period or delivery to a third party storage facility.  BAXTER hereby waives any and all rights of
recovery against AMYLIN and its Affiliates, and against any of their respective
directors, officers, employees, agents or representatives, for any loss or damage
to


 





















 


BAXTER Property to the extent the loss of damage is covered or could be
covered by insurance (whether or not such insurance is described in this
Agreement). AMYLIN assumes all risk of loss for all AMYLIN Supplied Components,
all Exenatide Drug Substance supplied by AMYLIN, and all Product after the
Storage Period or Additional Storage Period or delivery of the Batch pursuant
to Section 6.1 if such Exenatide Drug Substance and Product is not stored at a
third party storage facility (collectively, “AMYLIN Property”).  AMYLIN hereby waives any and all rights of
recovery against BAXTER and its Affiliates, and against any of their respective
directors, officers, employees, agents or representatives, for any loss or
damage to the AMYLIN Property to the extent the loss or damage is covered or
could be covered by insurance (whether or not such insurance is described in
this Agreement).


 


Article 14, INDEMNIFICATION


 


14.1         By Company
or Collaboration Partner. 
AMYLIN and Collaboration Partner, each with respect to its respective
actions, inactions or involvement with the Exenatide Drug Substance or Product,
agree to indemnify, defend and hold harmless BAXTER and its Affiliates and
their respective officers, employees and agents (“BAXTER Indemnitees”) from any
loss, expense (including reasonable legal counsel fees and expenses), cost,
liability or damages (“Losses”) incurred by any BAXTER Indemnitee as a result
of any claim, demand, action or other proceeding by any third party (“Claim”)
arising out of or related to (a) AMYLIN’s or Collaboration Partners’ breach of
any representation or warranty made by it in this Agreement, (b) the handling,
possession, storage or use of Product by or on behalf of AMYLIN following
delivery by BAXTER to AMYLIN, (c) AMYLIN’s or Collaboration Partner’s
promotion, labeling, marketing, supply or sale of Product, or (d) the inherent
clinical and pharmacological properties of the Exenatide Drug Substance and
Product, except in each case to the extent BAXTER is obligated to indemnify AMYLIN
or Collaboration Partner with respect to such Losses under Section 14.2.


 


14.2         By
Manufacturer. 
BAXTER shall indemnify and hold harmless AMYLIN and Collaboration
Partner and their respective Affiliates and their respective officers,
employees and agents (“AMYLIN Indemnitees”) from and against any and all Losses
to which any AMYLIN Indemnitee may become subject as a result of any Claim
arising out of or related to (a) BAXTER’s breach of any representation or
warranty made by BAXTER in this Agreement or (b) the negligence or willful
misconduct of BAXTER in the Production of Product, except in each case to the
extent AMYLIN is obligated to indemnify BAXTER with respect to such Losses
under Section 14.1 or the Losses are based on the negligence or willful misconduct
of any AMYLIN Indemnitee.


 





















 


14.3         Indemnitee Obligations. 
A party (the “Indemnitee”) which intends to claim indemnification under
this Article 14 shall promptly and in any event within thirty (30 days notify
the other party (the “Indemnitor”) in writing of any action, claim or other
matter in respect of which the Indemnitee or any of its Affiliates, or any of
their respective directors, officers, employees, subcontractors, or agents,
intend to claim such indemnification; provided, however, that failure to
provide such notice within a reasonable period of time shall not relieve the
Indemnitor of any of its obligations hereunder except to the extent the
Indemnitor is prejudiced by such failure. 
The Indemnitee shall permit, and shall cause its Affiliates, and their
respective directors, officers, employees, subcontractors and agents to permit,
the Indemnitor, at its discretion, to settle any such action, claim or other
matter, and the Indemnitee agrees to the complete control of such defense or settlement
by the Indemnitor.  Notwithstanding the
foregoing, the Indemnitor shall not enter into any settlement that would
adversely affect the Indemnitee’s rights, or impose any obligations on the
Indemnitee in order for it to exercise its rights, without Indemnitee’s prior
written consent, which shall not be unreasonably withheld or delayed.  No such action, claim or other matter shall
be settled without the prior written consent of the Indemnitor, which shall not
be unreasonably withheld or delayed.  The
Indemnitee, its Affiliates, and their respective directors, officers,
employees, subcontractors and agents shall fully cooperate with the Indemnitor
and its legal representatives in the investigation, defense or settlement of
any action, claim or other matter covered by the indemnification obligations of
this Article 14; provided, however,
that no Indemnitee shall be required to admit fault or responsibility in
connection with any settlement. 
The Indemnitee shall have the right, but not the obligation, to be
represented in such defense by counsel of its own selection and at its own
expense.


 


14.4         Injunction.  In the event that
the Production or sale of a Product is enjoined due to alleged infringement by
either party of the party of the proprietary rights of a third party, BAXTER
shall not be required to Produce Product and such non-Production shall not be
deemed a breach of this Agreement.


 


Article 15,  INSURANCE


 


15.1         AMYLIN Insurance. 
AMYLIN shall procure and maintain, upon receipt of Regulatory Approval, during
the Term of this Agreement and for a period one (1) year beyond the expiration
date of Product, Commercial General Liability Insurance, including without
limitation, Product Liability and Contractual Liability coverage (the “AMYLIN
Insurance”).  The AMYLIN Insurance shall
cover amounts not less than [***]
dollars ($[***]) combined single
limit and shall be with an insurance carrier reasonably acceptable to
BAXTER.  BAXTER shall be named as an
additional insured on the AMYLIN Insurance and AMYLIN promptly shall deliver a
certificate of AMYLIN Insurance and endorsement of


 










* Confidential Treatment Request(ed)


 





















 


additional
insured to BAXTER evidencing such coverage. 
If AMYLIN fails to furnish such certificates or endorsements, or if at
any time during the Term of this Agreement BAXTER is notified of the
cancellation or lapse of the AMYLIN Insurance, and AMYLIN fails to rectify the
same within ten (10) calendar days after notice from BAXTER, in addition to all
other remedies available to BAXTER hereunder, BAXTER, at its option, may obtain
the AMYLIN Insurance and AMYLIN promptly shall reimburse BAXTER for the cost of
the same. Any deductible and/or self-insurance retention shall be the sole
responsibility of AMYLIN.


 


15.2         BAXTER
Insurance.  BAXTER is, and
shall during the Term of this Agreement remain, self-insured under the global
self-insurance plan of Baxter Healthcare Corporation and its Affiliates for the
type of liability that could arise under Section 14.2 of this Agreement.


 


Article 16,  RECALL OF PRODUCT


 


16.1         In
the event AMYLIN or Collaboration Partner shall be required to recall any
Product because such Product may violate local, state or federal laws or
regulations, the laws or regulations of any applicable foreign government or
agency or the Product Specifications, or in the event that AMYLIN or
Collaboration Partner elects to institute a voluntary recall, AMYLIN or
Collaboration Partner shall be responsible for coordinating such recall.  AMYLIN or Collaboration Partner promptly
shall notify BAXTER if any Product is the subject of a recall and provide
BAXTER with a copy of all documents relating to such recall.  BAXTER shall cooperate with AMYLIN and/or
Collaboration Partner in connection with any recall.  Unless such recall is caused (a) solely by
the negligence of BAXTER, (b) or to the extent such recall is due to the
willful misconduct of BAXTER, or (c) such recall is caused solely by BAXTER’s
breach of this Agreement, AMYLIN and/or Collaboration Partner shall be
responsible for all of the costs and expenses of such recall and shall
reimburse BAXTER for its reasonable expenses (including labor) in connection
with such cooperation.  In the event a
recall is necessary because both (i) BAXTER has delivered a non-conforming
Product to AMYLIN, and (ii) such non-conformity is solely due to the negligence
or to the extent such recall is due to the willful misconduct of BAXTER, BAXTER
will bear all reasonable costs associated with such recall (including but not
limited to costs associated with receiving and administering the recalled
Product and notification of the recall to those persons whom AMYLIN and/or
Collaboration Partner deems appropriate) in accordance with and up to a
cumulative total maximum amount set forth in the chart below; notwithstanding
the chart below, provided, however, in no event shall BAXTER’s liability for
costs associated with such recall exceed [***] percent ([***]%)
of the Purchase Price paid to BAXTER by AMYLIN for the Product which is the
subject of such recall.


 










* Confidential Treatment Request(ed)


 





















 


Price paid to
BAXTER by AMYLIN for the Product which is the subject of such recall.


 




	
  Number of

  	
   

  	
  Recall Class

  (as classified

  by

  Regulatory

  Authority)

  	
   

  
	
  Consignees

  	
   

  	
  I

  	
   

  	
  II

  	
   

  	
  III

  	
   

  
	
  <[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  
	
  [***]-[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  
	
  [***]-[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  N/A

  	
   

  
	
  [***]-[***]

  	
   

  	
  $[***]

  	
   

  	
  $[***]

  	
   

  	
  N/A

  	
   

  
	
  >[***]

  	
   

  	
  $[***] per

  consignee

  	
   

  	
  $[***] per

  consignee

  	
   

  	
  N/A

  	
   

  






 


Article 17,  INTELLECTUAL
PROPERTY


 


17.1         Existing Intellectual Property.  Subject to Section 17.6, each party shall
continue to own its existing patents, trademarks, copyrights, trade secrets and
other intellectual property, without conferring any interests therein on the
other party. Without limiting the generality of the preceding sentence, AMYLIN
shall retain all right, title and interest arising under the United States
Patent Act, the United States Trademark Act, the United States Copyright Act
and all other applicable foreign and domestic laws, rules and regulations in
and to all Drug Products, Exenatide Drug Substance, Labeling and trademarks
associated therewith (collectively, “AMYLIN’s Intellectual Property”).  Neither BAXTER nor any third party shall
acquire any right, title or interest in AMYLIN’s Intellectual Property by
virtue of this Agreement or otherwise, except to the extent expressly provided
herein.


 


17.2         Individually
Owned Inventions. Except as the parties may otherwise agree in writing, all
Inventions (as defined herein) which are conceived, reduced to practice, or
created by a party in the course of performing its obligations under this
Agreement shall be solely owned and subject to use and exploitation by the
inventing party without a duty to account to the other party. For purposes of
this Agreement, “Invention” shall mean information relating to any innovation,
improvement, development, discovery, computer program, device, trade secret,
method, know-how, process, technique or the like, whether or not written or
otherwise fixed in any form or medium, regardless of the media on which contained
and whether or not patentable or copyrightable.


 










* Confidential Treatment Request(ed)


 





















 


17.3         Jointly
Owned Inventions.  All Inventions
which are conceived, reduced to practice, or created jointly by the parties
and/or their respective agents (i.e., employees or agents who would be or are
properly named as co-inventors under the laws of the United States on any
patent application claiming such inventions) in the course of the performance
of this Agreement shall be owned jointly by the parties.  Each party shall have full rights to exploit
such Inventions for its own commercial purposes without any obligation to the
other. The parties shall share equally in the cost of mutually agreed patent
filings with respect to all such jointly owned Inventions. The decision to file
for patent coverage on jointly owned Inventions shall be mutually agreed upon,
and the Parties shall select a mutually acceptable patent counsel to file and
prosecute patent applications based on such joint Inventions.


 


17.4         Disclaimer.  Except as otherwise expressly provided
herein, nothing contained in this Agreement shall be construed or interpreted,
either expressly or by implication, estoppel or otherwise, as: (i) a grant,
transfer or other conveyance by either party to the other of any right, title,
license or other interest of any kind in any of its Inventions or other intellectual
property, (ii) creating an obligation on the part of either party to make any
such grant, transfer or other conveyance or (iii) requiring either party to
participate with the other party in any cooperative development program or
project of any kind or to continue with any such program or project.


 


17.5         Rights in IP.  The party owning any IP shall have the world
wide right to control the drafting, filing, prosecution and maintenance of
patents covering the Inventions relating to such IP, including decisions about
the countries in which to file patent applications.  Patent costs associated with the patent
activities described in this Section shall be borne by the sole owner.  Each party will cooperate with the other
party in the filing and prosecution of patent applications. Such cooperation
will include, but not be limited to, furnishing supporting data and affidavits
for the prosecution of patent applications and completing and signing forms
needed for the prosecution, assignment and maintenance of patent applications.


 


17.6         Manufacturing Process License.  BAXTER hereby
grants AMYLIN a perpetual, irrevocable, exclusive, worldwide, royalty-free,
fully paid-up license, with the right to sublicense, to all of BPS’ rights in
and to the means, methods, techniques, know-how, processes and procedures
developed under this Agreement or the Development Agreement with respect to the
manufacturing process (the “Manufacturing Process”) of Product.   BAXTER shall retain all rights in and to the
means, the methods, techniques, know-how, processes and procedures developed
under this Agreement or the Development Agreement with respect to the
manufacturing process of any product other than Product.  BAXTER shall not enforce any intellectual
property rights belonging to BAXTER against AMYLIN or its sublicensees, to use,
make, have made, import, offer to sell, have sold and sell Product.


 





















 


17.6         Confidentiality
of IP.  IP shall be deemed to
be the Confidential Information of the party owning such IP.  The protection of each party’s Confidential
Information is described in Article 18. 
Any disclosure of information by one party to the other under the
provisions of this Article 18 shall be treated as the disclosing party’s
Confidential Information under this Agreement. 
It shall be the responsibility of the party preparing a patent
application to obtain the written permission of the other party to use or
disclose the other party’s Confidential Information in the patent application
before the application is filed and for other disclosures made during the
prosecution of the patent application.


 


Article 18,  CONFIDENTIAL
INFORMATION, NONDISCLOSURE AND PUBLICITY


 


18.1         Confidentiality.  This Agreement, by reference, incorporates
the provisions of the Confidentiality Agreement signed by AMYLIN, Collaboration
Partner, and BAXTER on December 8, 2003, and is made a part hereof as though
fully set forth herein.  To the extent
there is any discrepancy between the provisions of the Confidentiality Agreement
and this Agreement, the provisions of the Confidentiality Agreement shall
prevail. It is contemplated that in the course of the performance of this
Agreement each party may, from time to time, disclose Confidential Information
to the other.  Each party agrees to take
all reasonable steps to prevent disclosure of Confidential Information to third
parties.  No provision of this Agreement
shall be construed so as to preclude disclosure of Confidential Information as
may be reasonably necessary to secure from any governmental agency necessary approvals
or licenses or to obtain patents with respect to the Product.


 


18.2         Third Party
Disclosure.  BAXTER shall be
permitted to disclose Product information to third party developmental and
analytical services providers in connection with performance of its obligations
hereunder provided such providers shall be subject to confidentiality
agreements.  Either party may disclose
Confidential Information of the disclosing party to those Affiliates, agents
and consultants who need to know such information to accomplish the purposes of
this Agreement (collectively, “Permitted Recipients”); provided that such
Permitted Recipients are bound to maintain such Confidential Information in
confidence.


 


18.3         Litigation
and Governmental Disclosure. 
Each party may disclose Confidential Information hereunder to the extent
such disclosure is reasonably necessary for prosecuting or defending
litigation, complying with applicable governmental regulations or conducting
pre-clinical or clinical trials, provided that if a party is required by law or
regulation to make any such disclosure of the other party’s Confidential
Information it will, except where impractical for necessary disclosures, for
example in the event of a medical emergency, give reasonable


 





















 


advance notice to the other party of such
disclosure requirement and will use good faith efforts to assist such other
party to secure a protective order or confidential treatment of such
Confidential Information required to be disclosed.


 


18.4         Limitation
of Disclosure.  The parties
agree that, except as otherwise may be required by applicable laws,
regulations, rules or orders, including without limitation the rules and
regulations promulgated by the United States Securities and Exchange
Commission, and except as may be authorized in Section 18.4, no information
concerning this Agreement and the transactions contemplated herein shall be
made public by either party without the prior written consent of the other.


 


18.5         Publicity
and SEC Filings.  Unless the
prior written consent of the other party is obtained, no party shall, except as
may be required by law or regulations (including without limitation any United
States Securities and Exchange Commission filings required), in any manner
disclose or advertise or publish or release for publication any statement
mentioning the other party or information contained in or acquired pursuant to
this Agreement, or the fact that any party has furnished or contracted to
furnish to the other party the items required by this Agreement, or quote the
opinion of any employee of the other party. 
BAXTER acknowledges that AMYLIN is required to file a Form 8-K,
disclosing the existence of and the material, non-confidential terms of this
Agreement.  BAXTER further acknowledges
that AMYLIN is required to disclose to its investors the existence of this
Agreement.  Each party agrees that it
shall cooperate fully and in a timely manner with the other with respect to all
disclosures to the Securities and Exchange Commission and any other
governmental or regulatory agencies, including providing sufficient time to
review requests for confidential treatment of Confidential Information of
either party included in any such disclosure.


 


18.6         Duration of
Confidentiality.  All
obligations of confidentiality and non-use imposed upon the parties under this
Agreement shall expire ten (10) years after the expiration or earlier
termination of this Agreement; provided, however, that Confidential Information
which constitutes the trade secrets of a party shall be kept confidential
indefinitely, subject to the limitations set forth in Sections 18.3 through
18.5.


 


Article 19,  FORCE MAJEURE


 


19.1         Any delay in the
performance of any of the duties or obligations of either party hereto (except
the payment of money) caused by an event outside the affected party’s
reasonable control shall not be considered a breach of this Agreement, and
unless provided to the contrary herein, the time required for performance shall
be extended for a period equal to the period of such delay.  Such events which are outside a party’s
reasonable control shall include without limitation, acts of God;


 





















 


acts of public
enemies; insurrections; riots; injunctions; embargoes; fires; explosions;
floods; shortages of material or energy which are beyond the reasonable control
of either party; delays in the delivery of raw materials which are beyond the
reasonable control of either party; acts or orders of any government or agency
thereof or other unforeseeable causes beyond the reasonable control and without
the fault or negligence of the party so affected.  The party so affected shall give prompt
notice to the other party of such cause and a good faith estimate of the
continuing effect of the force majeure condition and duration of the affected
party’s nonperformance, and shall take whatever reasonable steps are
appropriate to relieve the effect of such causes as rapidly as possible.  If the period of nonperformance by BAXTER
because of BAXTER force majeure conditions exceeds ninety (90) calendar days,
AMYLIN may terminate this Agreement by written notice to BAXTER.  If the period of nonperformance by AMYLIN
because of AMYLIN force majeure conditions exceeds ninety (90) calendar days,
BAXTER may terminate this Agreement by written notice to AMYLIN.


 


Article 20,  NOTICES


 


20.1         All notices hereunder
shall be delivered by facsimile (confirmed by overnight delivery), or by
overnight delivery with a reputable overnight delivery service, to the
following address of the respective parties:


 


	
  If to
  BAXTER:

  	
   

  	
  Baxter
  Pharmaceutical Solutions LLC

  
	
   

  	
   

  	
  927 South
  Curry Pike

  
	
   

  	
   

  	
  Bloomington,
  Indiana 47403

  
	
   

  	
   

  	
  Attn:
  Contract Management

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax No.

  	
  812-332-3079

  
	
   

  	
   

  	
  Telephone
  No.

  	
  812-333-0887

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  With a copy
  to:          Baxter
  Healthcare Corporation

  
	
   

  	
   

  	
  One Baxter
  Parkway

  
	
   

  	
   

  	
  Deerfield,
  Illinois 60015-4633

  
	
   

  	
   

  	
  Attn:
  General Counsel

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax No.

  	
  (847)
  948-2450

  
	
   

  	
   

  	
  Telephone
  No.

  	
  (847)
  948-2600

  
	
   

  	
   

  	
   

  
	
  If to
  AMYLIN:

  	
   

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9360 Towne
  Centre Drive,

  
	
   

  	
   

  	
  Suite 110

  
	
   

  	
   

  	
  San Diego,
  CA 92121

  



 





















 


	
   

  	
   

  	
  Attn: John
  Grove, Senior Director of Manufacturing

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax No.

  	
  (858)
  334-1082

  
	
   

  	
   

  	
  Telephone
  No.

  	
  (858)
  642-7082

  
	
   

  	
   

  	
   

  	
   

  
	
  With a copy
  to:

  	
   

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9360 Towne
  Centre Drive,

  
	
   

  	
   

  	
  Suite 110

  
	
   

  	
   

  	
  San Diego,
  CA 92121

  
	
   

  	
   

  	
  Attn: Vice
  President and General Counsel

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax No.
  (858) 552-1936

  
	
   

  	
   

  	
  Telephone
  No. (858) 642-7066

  



 


Notices shall
be effective on the day following the date of transmission if sent by facsimile
or email, and on the second business day following the date of delivery to the
overnight delivery service if sent by overnight delivery.  A party may change its address listed above
by notice to the other party given in accordance with this section.


 


Article 21,  APPLICABLE LAW


 


21.1         Governing Law.  In
any action brought regarding the validity, construction and enforcement of this
Agreement, it shall be governed in all respects by the laws of the State of
Delaware, without regard to the principles of conflicts of laws.


 


21.2         Dispute Resolution.  In the event a dispute arises and the parties
cannot in good faith agree on a mutually acceptable resolution, each party
shall submit the dispute to their senior management, who shall in good faith
endeavor to resolve such dispute.  In the
event the senior management of each party cannot resolve said dispute, the
parties may pursue remedies available at law or in equity.


 


Article 22,  ASSIGNMENT


 


22.1         Neither party shall
assign this Agreement or any part hereof or any interest herein to any third
party (or use any subcontractor) without the written approval of the other
party.  BAXTER may, without such consent,
assign this Agreement to an Affiliate of BAXTER.  In addition, no consent shall be required in
the case of a transfer to a wholly-owned subsidiary or transaction involving
the merger, consolidation, or sale of all or substantially all of the assets of
the party seeking such assignment or transfer and such transaction relates to
the business covered by this Agreement and the resulting entity assumes all of
the obligations under


 





















 


this Agreement.  No assignment shall be valid unless the
permitted assignee(s) assumes all obligations of its assignor under this
Agreement.  No assignment shall relieve
any party of responsibility for the performance of its obligations hereunder.


 


Article 23,  ALLIANCES


 


23.1         Notwithstanding anything
to the contrary herein, BAXTER agrees that AMYLIN shall have the right to enter
into alliances with third parties who may engage in joint (with AMYLIN) or
unilateral marketing and promoting of the Product or any combination of products
that includes the Product.


 


Article 24,  TAXES


 


24.1         AMYLIN shall pay all
national, state, municipal or other sales, use, excise, import, property, value
added, or other similar taxes, assessments or tariffs assessed upon or levied
against the sale of Product to AMYLIN pursuant to this Agreement or the sale or
distribution of Product by AMYLIN (or at AMYLIN’s sole expense, defend against
the imposition of such taxes and expenses). 
BAXTER shall notify AMYLIN of any such taxes that any governmental authority
is seeking to collect from BAXTER, and AMYLIN may assume the defense thereof in
BAXTER’s name, if necessary, and BAXTER agrees to fully cooperate in such
defense to the extent of the capacity of BAXTER, at AMYLIN’s expense.  BAXTER shall pay all national, state,
municipal or other taxes on the income resulting from the sale by BAXTER of the
Product to AMYLIN under this Agreement, including but not limited to, gross
income, adjusted gross income, supplemental net income, gross receipts, excess
profit taxes, or other similar taxes.


 


Article 25,  SUCCESSORS AND
ASSIGNS


 


25.1         This Agreement shall be
binding upon and shall inure to the benefit of the parties hereto, their
successors and permitted assigns.


 


Article 26,  ENTIRE AGREEMENT


 


26.1         This Agreement
constitutes the entire agreement between the parties concerning the subject
matter hereof and supersedes all written or oral prior agreements or
understandings with respect thereto.  The
parties agree and acknowledge that the Drug Product Development Agreement dated
February 27, 2004 and corresponding Development Plans and/or Project Plans
thereunder between AMYLIN and BAXTER shall not be superceded by this Agreement
and shall remain in full force and effect.


 





















 


Article
27,  SEVERABILITY


 


27.1         If any term or provision
of this Agreement shall for any reason be held invalid, illegal or
unenforceable in any respect, such invalidity, illegality or unenforceability
shall not affect any other term or provision hereof, and this Agreement shall
be interpreted and construed as if such term or provision, to the extent the
same shall have been held to be invalid, illegal or unenforceable, had never
been contained herein.


 


Article 28,  WAIVER AND
MODIFICATION OF AGREEMENT


 


28.1         No Waiver of Agreement.  No waiver or modification of any
of the terms of this Agreement shall be valid unless in writing and signed by
authorized representatives of both parties hereto.  Failure by either party to enforce any rights
under this Agreement shall not be construed as a waiver of such rights nor
shall a waiver by either party in one or more instances be construed as
constituting a continuing waiver or as a waiver in other instances.


 


28.2         Amendment of Plans.  Each Project Plan, Regulatory Plan, and
Exhibit may be amended from time to time only upon the mutual written agreement
of AMYLIN and BAXTER.


 


28.3         No Amendment of Agreement.  In the event that
the terms of any Project Plan, Regulatory Plan, or Exhibit are inconsistent
with the terms of this Agreement, this Agreement shall control, unless
otherwise explicitly agreed to in writing by the parties.  Not Project Plan, Regulatory Plan, or Exhibit
shall be deemed to amend this Agreement. 
Upon execution of any Project Plan, Regulatory Plan, or Exhibit, such
Plan or Exhibit shall be deemed to be incorporated herein and by reference and
made a part of this Agreement.


 


Article 29,  INDEPENDENT
CONTRACTOR


 


29.1        BAXTER shall act as an
independent contractor for AMYLIN in providing the services required hereunder
and shall not be considered an agent of, or joint venturer with, AMYLIN.


 


Article 30, 
ATTORNEY’S FEES


 


30.1         The successful
party in any litigation or other dispute resolution proceeding to enforce the
terms and conditions of this Agreement shall be entitled to recover from the
other party reasonable attorney’s fees and related costs involved in connection
with such litigation or dispute resolution proceeding.


 





















 


Article 31,  COOPERATION WITH
COLLABORATION PARTNER


 


31.1         BAXTER
acknowledges that AMYLIN’s Collaboration Partner will serve as the regulatory
lead in all jurisdictions outside the United States.  BAXTER agrees to cooperate with Collaboration
Partner in all matters relating to supply for and regulatory compliance in
jurisdictions outside the U.S and to permit Collaboration Partner access to all
facilities, records and information that Collaboration Partner may reasonably
request in connection therewith to the same extent as such cooperation and
access is to be provided to AMYLIN pursuant to the terms and conditions of this
Agreement with regard to the U.S. regulatory matters. Collaboration Partner
shall be deemed a beneficiary of this Agreement, shall have the right to cure
any breach of this Agreement by AMYLIN, and with the consent of AMYLIN, which
such consent shall not be unreasonably withheld, may assume AMYLIN’s
obligations under this Agreement and/or institute legal action to enforce the
terms of this Agreement; provided that Collaboration Partner provide BAXTER
with prompt written notice and evidence of such assumption.


 


IN WITNESS
WHEREOF, the parties have caused this Commercial
Supply Agreement to be signed by their duly authorized representatives as of
the Effective Date written above.


 


	
  “BAXTER”

  	
   

  	
  “AMYLIN”

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  BAXTER
  PHARMACEUTICAL
SOLUTIONS LLC

  	
   

  	
  AMYLIN
  PHARMACEUTICALS, INC.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Joel Tune

  	
   

  	
  By:

  	
  /s/ Gregg Stetsko

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Joel Tune

  	
  Name:

  	
  Greg Stetsko

  
	
  Title:

  	
  Vice
  President

  	
  Title:

  	
  Vice
  President, Operations

  
								



 





















 


“ACKNOWLEDGEMENT AND AGREEMENT”


 


In consideration of, and as an
inducement to Baxter Pharmaceuticals Solutions LLC to enter into the Commercial
Supply Agreement with Amylin Pharmaceuticals, Inc. with an Effective Date of 14
February, 2005 (the “Agreement”), Collaboration Partner acknowledges and agrees
that Collaboration Partner will comply with all obligations of Collaboration
Partner provided in the Agreement and any obligations assumed by Collaboration
Partner (including those assumed in accordance with Section 31.1 of the
Agreement).  BAXTER may institute legal
actions against Collaboration Partner to enforce such obligations.


 


IN WITNESS WHEREOF,
Collaboration Partner has caused this acknowledgement and agreement to be
signed by is duly authorized representative as of the Effective Date of the
Agreement.


 


	
  “COLLABORATION
  PARTNER”

  
	
   

  
	
   

  
	
  ELI
  LILLY AND COMPANY

  
	
   

  
	
   

  
	
  By:

  	
  /s/ D.M.
  Green

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  D.M. Green

  
	
  Title:

  	
  Vice
  President & CPO

  



 





















 


Exhibit A - Presentations


 


	
  Product Name

  	
   

  	
  BAXTER Item

  Code

  	
   

  	
  LILLY Item

  Number

  	
   

  	
  AMYLIN

  Product

  Reference

  Number

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Exenatide
  1.5 mL Injection Cartridge (0.25 mg/ml; 1.2mL in 1.5ml cartridge)

  	
   

  	
  250-103-103

  	
   

  	
  VL7627

  	
   

  	
  210-03

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Exenatide
  2.7 mL Injection Cartridge (0.25 mg/ml; 2.4 mL in 2.7mL cartridge)

  	
   

  	
  250-103-104

  	
   

  	
  VL7628

  	
   

  	
  210-04

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Placebo for
  Exenatide Injection in cartridges (1.2 mL in 1.5ml cartridge)

  	
   

  	
  [TBD]

  	
   

  	
  N/A

  	
   

  	
  SPEC-105

  	
   

  



 





















 


Exhibit B – Pricing


 


Purchase Price


 


BAXTER shall charge AMYLIN the
following Purchase Price for Product pursuant to Article 5.


 


	
  Annual Volume (all
  Presentations)

  	
   

  	
  250-103-103, 250-103-104, and Placebo

  	
   

  
	
  Units: [***] to [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Units: [***] to [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Units: [***] to [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Units: [***] and above

  	
   

  	
  $

  	
  [***]

  	
   

  



 


Annual
Product Quality Review


 


BAXTER
will produce an annual batch review/comparison summary per year for use by
AMYLIN regulatory at a charge not to exceed $[***] per hour.  Such Annual
Product Quality Review will be performed pursuant to the Quality Agreement.


 


Quality
Assurance Audits


 


A
charge not to exceed $[***] per
hour will be paid to BAXTER for quality assurance audits in excess of one per
year, unless related to BAXTER’s compliance status.  The hours charged will include preparation
time, audit time by all BAXTER participants, and follow-up time in preparing
responses.  A charge not to exceed $[***] per hour will be paid to BAXTER
for physical inventory audits.  The hours
charged will include preparation time, audit time by all BAXTER participants,
and follow-up time in preparing responses.


 


Regulatory
Support


 


A
charge not to exceed $[***] per
hour will be paid to BAXTER for regulatory support performed pursuant to a
Regulatory Plan.


 


Batch Records


 


A charge not to exceed $[***] per hour will be paid to BAXTER
for AMYLIN requested revisions to Master Batch Records in excess of one per
year.  There shall be no charge for any
revisions to Master Batch Records which are necessary for BAXTER to meet
Regulatory Authority Requirements.  A
charge of $[***] per batch
record will be paid to BAXTER for distribution of additional executed batch
records in excess of one per year.


 


Storage
of Product


 


A
charge not to exceed $[***] per
pallet per month will be paid to BAXTER for the storage of Product in excess of
the Storage Period as defined in Section 3.7.1.


 










* Confidential Treatment Request(ed)


 





















 


Storage
of Components


 


A
charge not to exceed $[***] per
pallet per month will be paid to BAXTER for the storage of Components in excess
of [***] months of the Rolling
Forecast if requested by AMYLIN.


 










* Confidential Treatment Request(ed)


 





















 


Exhibit C - Product Specifications


 


Purchase Specification for
Exenatide Injection in Cartridges


 


Description:    [***] containing [***] mg/mL peptide, [***]% (w/v) [***], [***]% (w/v) [***]
in [***] mM pH [***] [***] in 1.2, 2.4, or 3.0 mL cartridges with [***] and [***].


 


Note these Specifications
may be changed according to the process described in Section 7 of the Quality
Agreement.


 


	
  ATTRIBUTE

  	
   

  	
  SPECIFICATION(3)

  	
   

  	
  METHOD(1)

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***]

  	
   

  
	
  [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  NMT [***]
  counts/container NLT [***] mm

  NMT [***] counts/container NLT
  [***] mm

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***] to [***] [***]/kg

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***] ±
  [***] Da

  	
   

  	
  [***]

  	
   

  
	
  [***]

  [***]

  [***]

  	
   

  	
  [***]

  [***]% to [***]%

  [***]% to [***]% of [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  Total [***]

  Individual [***]

  [***]AC2993

  [***]AC2993

  	
   

  	
  NLT [***]%

  NMT [***]%

  

  NMT [***]%

  NMT [***]%

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]% to [***]% of reference standard

  	
   

  	
  [***] or [***]

  	
   

  
	
  [***]

  	
   

  	
  LT [***] EU/mL

  	
   

  	
  [***] or [***]

  	
   

  
	
  [***]

  	
   

  	
  [***] ([***])

  	
   

  	
  [***] or [***]

  	
   

  
	
  [***]

  	
   

  	
  NMT [***]

  	
   

  	
  [***] or [***]

  	
   

  
	
  [***]

  	
   

  	
  NMT [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NLT [***]

  	
   

  	
  [***],

  [***] or

  [***]

  	
   

  



 










(1).  [***]
([***]) are used for [***] and [***], except [***]
A, B, C and D are used for [***]
or [***], and may be used in [***].


(2).  [***]
are, for [***], [***]; for [***], [***]; for [***], [***]; and for [***],
[***].


 


* Confidential Treatment Request(ed)


 





















 


(3).  As it relates to Baxter’s obligations under the Supply
Agreement, the defined term Specifications includes only those test that Baxter
is conducting; namely, [***], [***], [***], [***] and [***]. 
All other tests and specifications reported herein are for information
purposes only.


 


NMT – Not more
than


NLT – Not less
than


LT – Less than


 


* Confidential Treatment Request(ed)


 





















 


Exhibit D – Raw Material and Component
Specifications


 


Exenatide Drug Substance is supplied by AMYLIN.  All other Components are supplied by BAXTER.


 


Formulation and Raw Material Details


 


	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier

  Location

  	
   

  	
  Specification

  	
   

  	
  Vendor

  Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  NA

  	
   

  	
  [***]

  	
   

  	
  N/A

  	
   

  



 










* Confidential Treatment Request(ed)


 





















 


Manufacturing Consumables


 


	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier

  Location

  	
   

  	
  Specification

  	
   

  	
  Vendor

  Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]% [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


1.5 mL Cartridges-Component specifications


 


	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier Location

  	
   

  	
  Specification

  	
   

  	
  Vendor

  Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  



 










* Confidential Treatment Request(ed)


 





















 


2.7 mL Cartridges-Component specifications


 


	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier

  Location

  	
   

  	
  Specification

  	
   

  	
  Vendor

  Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  



 










* Confidential Treatment Request(ed)


 





















 


Exhibit E – Regulatory Authorities


 


United States


 


European Union


Australia


Canada


Brazil


Mexico


Switzerland


Russia


 





















 


Exhibit F -  Annual Obligation


 


	
  YEAR

  	
   

  	
  ANNUAL OBLIGATION

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First calendar year following Regulatory Approval

  	
   

  	
  0

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Second calendar year following Regulatory Approval

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Third calendar year following Regulatory Approval

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Fourth calendar year following Regulatory Approval

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Fifth calendar year following Regulatory Approval

  	
   

  	
  [***]

  	
   

  



 










* Confidential Treatment Request(ed)