Exhibit 10.40

***Text Omitted and Filed Separately
with the Securities and Exchange Commission
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2.

C O N F I D E N T I A L

COMMERCIAL SUPPLY AGREEMENT

THIS SUPPLY AGREEMENT (the “Agreement”) is entered into as of October 12, 2006
(the “Effective Date”), by and between AMYLIN PHARMACEUTICALS, INC. (“Company”),
having its principal place of business located at 9360 Towne Centre Drive,
Suite 110, San Diego, CA 92121, U.S.A., and Wockhardt UK (Holdings) Ltd.
(“Manufacturer”), having its registered office at Ash Road North, Wrexham
Industrial Estate, Wrexham LL13 9UF, United Kingdom.

RECITALS

WHEREAS, Manufacturer is in the business of manufacturing pharmaceutical
products;

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

WHEREAS, Company and Manufacturer (then CP Pharmaceuticals Ltd) having
previously entered into a Manufacturing Agreement, effective from 28th April
1999 and now mutually wish to supercede such agreement with the terms and
conditions set forth herein; and

WHEREAS, Company wishes to purchase from Manufacturer, and Manufacturer is
willing to manufacture and supply to Company, the Product (as defined below) in
commercial quantities for commercial sale on the terms and conditions set forth
herein.

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and
premises contained in this Agreement, the parties hereto agree as follows:

1.             Definitions.

1.1          “Affiliate” shall mean an entity that, directly or indirectly,
controls, is controlled by or is under common control with a party, where
“control” means the possession, direct or indirect, or the power to direct or
cause the direction of the management or policies of an entity, whether by
ownership of at least 50% of the common stock or voting ownership interest of an
entity, by contract or otherwise.

  

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1.2          “Applicable Laws” shall mean all United States and European
jurisdiction’s federal, state, local and other laws, statutes, rules,
regulations, ordinances, (including any amendments thereto), applicable to the
manufacture and shipment of Product, including, without limitation, the
applicable regulations and guidance of the FDA, all applicable EU cGMPs.
Extensions to the aforementioned defined territories shall be the subject of
side letters to this Agreement which may be jointly agreed in good faith from
time to time between the parties.

1.3          “Batch” shall mean that quantity of units of Product produced from
a single homogeneous mix in a single cycle of manufacture.

1.4          “Batch Record” shall mean Manufacturer’s documented procedures for
compounding, filling, testing, labeling, and packaging Pramlintide Acetate Drug
Substance and/or inactive excipients into Product as agreed upon by the parties
in writing in advance of manufacture of the applicable Batch.

1.5          “Business Day” shall mean any Monday, Tuesday, Wednesday, Thursday
or Friday which is not a bank holiday in San Diego, California or the United
Kingdom.

1.6          “Certificate of Analysis” shall mean a signed certificate, issued
by the party providing a pharmaceutical compound or product, attesting to the
nature and/or content, as applicable, of such compound or product.

1.7          “cGMP” shall mean current good manufacturing practices as defined
from time to time (a) in regulations promulgated under the FDCA; (b) the
principles and guidelines specified in Chapter II of European Commission
Directive 91/356/EEC, including “the rules governing medicinal products” in the
European Union Volume 4; and (c) laws, rules, or regulations of an applicable
Regulatory Authority at the time of manufacture equivalent to those in (a) and
(b) above.

1.8          “Confidential Information” of a party shall mean all data and
information, tangible or intangible, whether in written, graphic, verbal or
electronic form, disclosed by such party to the other party, its employees or
representatives, or developed for or on behalf of such party by the other party
under this Agreement.

1.9          “Contaminant” means a substance contained in Product that (i)
causes Product to fail to meet any Product Requirements or (ii) causes Product
to be adulterated within the meaning of the FDCA.

1.10        “Control” shall mean, with respect to certain rights, possessing
ownership of or possessing the right to grant a license to such rights.

1.11        “Drug Approval Application” shall mean an application and/or
supplemental application for Regulatory Approval required before commercial sale
or use of Product as a drug in a regulatory jurisdiction.

1.12        “Facilities” shall mean the manufacturing plant and offices owned by
Manufacturer and located at Ash Road North, Wrexham Industrial Estate, Wrexham
LL13 9UF,

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United Kingdom and a storage and distribution facility owned by Manufacturer and
located at Unit B, Spectrum Business Park, Bridge Road South, Wrexham Industrial
Estate, Wrexham LL13 9QA, United Kingdom.

1.13        “FDA” shall mean United States Food and Drug Administration or any
successor agency.

1.14        “FDCA” shall mean the United States Federal Food Drug and Cosmetics
Act, as amended, and all regulations promulgated thereunder, or any successor
laws and regulations thereto

1.15        “Fill Date” shall mean that date on which the manufacture of a Batch
is actually completed, notwithstanding the date on which the Batch manufacture
begins.

1.16        “Hidden Defect” shall mean a defect that causes Product to fail to
conform to the Specifications or to the warranties provided by Manufacturer
hereunder, which defect is not discoverable upon reasonable physical inspection
and testing performed pursuant to Section 5.3 but is discovered at a later time
(e.g., in the course or as a result of long-term stability studies).

1.17        “Launch Date” shall mean the date of the first commercial sale of
Product manufactured using Manufacturer Technology under this Agreement, in a
country after approval by appropriate regulatory authorities for market and sale
in such country.

1.18        “Manufacturing Process” shall mean any and all specifications,
compositions, identities and quantities of materials, formulas, methods,
techniques, processes, procedures and quality control necessary or relevant for
manufacture of Product.

1.19        “Manufacturer’s Technology” shall mean the specific and confidential
technology which has been developed by Manufacturer for the siliconisation of
glass cartridges used in the production of the Product as defined herein and is
described further in related standard operating procedures (“SOPs”) .

1.20        “Materials” shall mean raw materials, components, excipients and
other ingredients and packaging materials used in the manufacture and packaging
of Product.

1.21        “OUS Country” shall mean any country outside of the United States
and its territories.

1.22        “Pramlintide Acetate or Pramlintide Acetate Drug Substance” shall
mean a dry bulk powder preparation containing pramlintide acetate peptide as
provided by Company for further manufacture into Product by Manufacturer.

1.23        “Product” shall mean the finished dosage form of Pramlintide
Acetate, for injection in cartridge presentation as described in Exhibit B to
this Agreement.

1.24        “Product Price” shall mean the price for Product set forth in
Exhibit A.

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1.25        “Product Requirements” shall mean all of the requirements referenced
in Section 8.3 of this Agreement.

1.26        “Quality Agreement” shall mean the (Technical) Quality Agreement
between Company and Manufacturer dated as of October 16, 2002, or that agreed in
writing on any subsequent date between the parties, which is incorporated into
this Agreement by reference and made a part hereof.

1.27        “Recall Action” shall have the meaning ascribed to it in Section
5.4 hereof.

1.28        “Regulatory Approval” shall mean any approvals (including
supplements, amendments, pre-marketing and post-marketing approvals, labeling
approval, and pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national (e.g., the European Commission or
the Council of the European Union), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, necessary
for the manufacture, distribution, use or sale of Product in a regulatory
jurisdiction.

1.29        “Regulatory Authority” shall mean the FDA in the United States or
the MHRA, EMEA or any other 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
additional country, or any successor body to any of them.

1.30        “Specifications” shall mean the regulatory, manufacturing, quality
control and quality assurance procedures, processes, practices, standards,
instructions and any other attributes that the parties agree upon, or that are
otherwise required, in connection with the manufacture of Product, as set forth
on Exhibit B, as amended from time to time by written agreement of the parties
pursuant to Section 4.3.

1.31        “Term” shall have the meaning provided in Section 9.1.

2.             Purchase and Supply.

2.1          Purchase and Supply Agreement.  During the Term, Company agrees to
buy from Manufacturer, and Manufacturer agrees to sell to Company, such
quantities of the Product as may be set forth on purchase orders placed by
Company in accordance with the provisions hereof.

2.2          Minimum Orders.  For the time frame beginning on the Effective Date
and ending on the first day of the calendar month after the date of the one year
anniversary of the date of the first Regulatory Approval of the Product (the
“Initial Period”), Company shall only be obligated to purchase, and Manufacturer
shall only be obligated to supply, that quantity of Product ordered by Company,
which is submitted to Manufacturer via purchase order and Manufacturer accepts
via a confirmation.   For the time frame beginning on the date the Initial
Period ends and ending on the one year anniversary thereof (the “Second
Period”), Company agrees to purchase Product from Manufacturer in an amount
equal to or greater than [***]

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cartridges. For the time frame beginning on the date the Second Period ends and
ending on the one year anniversary thereof (the “Third Period”), Company agrees
to purchase Product from Manufacturer in an amount equal to or greater than
[***] cartridges. For the time frame beginning on the date the Third Period ends
and ending on the one year anniversary thereof (the “Fourth Period”), Company
agrees to purchase Product from Manufacturer in an amount equal to or greater
than [***] cartridges. For the time frame beginning on the date the Fourth
Period ends and ending on the one year anniversary thereof (the “Fifth Period,”
and together with the Initial Period, the Second Period, the Third Period, and
the Fourth Period, the “Purchase Periods”), Company agrees to purchase Product
from Manufacturer in an amount equal to or greater than [***] cartridges.  Not
withstanding the foregoing, however, the Parties agree that upon completion of
the Initial Period, the Parties shall meet for the purpose of reconsidering each
of the foregoing quantities specified for the Third, Fourth and Fifth Periods
and shall, prior to the commencement of the Third Period, adjust such
quantities, if necessary, upon mutual written agreement.  In the event that
during any Purchase Period the Company’s actual purchases of the Product from
Manufacturer are less than the minimum amount specified above for said Purchase
Period, Company will pay to Manufacturer the difference between the amount
invoiced to Company for its actual purchases during the Purchase Period and the
amount that would have been invoiced had Company purchased the minimum amount
agreed to for such Purchase Period; provided, however, (i) Company shall not be
obligated to make any such payments if the Agreement has been terminated, and
(ii) the Company shall only be obligated to pay for Product supplied to the
Company pursuant to this Agreement.  In any given calendar quarter, Company
shall order [***]% of the minimum quantity, plus or minus [***]%, for the
Purchase Period in which the calendar quarter occurs.  Following the Fifth
Period, Manufacturer may bid, in competition with Company’s other manufacturers
of the Product, to provide a greater percentage of Company’s requirements of the
Product.  For purposes of this Section 2.2, a “purchase” shall mean the
submission by Company of a firm purchase order.

2.3          Forecasts.  Beginning within seven (7) days after the Effective
Date and at the commencement of every calendar month thereafter, Company shall
furnish Manufacturer with non-binding forecasts of [***] Product requirements
under this Agreement for the ensuing [***] calendar [***].

2.4          Purchase Orders.  Company shall order the Product by submitting
written purchase orders, in Company’s standard form in effect from time to time,
to Manufacturer.  Each purchase order shall specify the quantities of the
Product ordered which shall be in Batch quantities or multiples thereof, the
cartridge size thereof, the desired shipment date for such Product, the pricing,
and any special shipping instructions.  Company shall submit each purchase order
to Manufacturer at least [***] Business Days in advance of the desired shipment
date specified in such purchase order. No more than ten (10) Business Days
following receipt of each purchase order Manufacturer shall confirm in writing
its acceptance of same and shall advise Company of its planned shipment date and
its designated lot numbers for the Product.  Manufacturer shall make each
shipment of the Product in the quantity, cartridge size and on the shipment date
specified for it on Company’s purchase order, via the mode(s) of transportation
and to the party and destination specified on such purchase order.  Release
samples representing the Manufacturing Process and meeting the requirements set
forth in the Batch Record will be shipped within [***] Business Days after the
actual Fill Date.

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Manufacturer shall ship the Product which is the subject of the purchase order,
subject to Section 5.1, and shall supply copies of the associated documentation
as described in the Quality (Technical) Agreement, including the signed
Certificate of Analysis and signed certificate of compliance for the Product.
Any purchase orders for the Product submitted by Company to Manufacturer shall
reference this Agreement and shall be governed exclusively by the terms
contained herein except to the extent set forth in the following sentence. The
terms and conditions of this Agreement shall supersede any term or condition in
any order, confirmation or other document furnished by Company or Manufacturer
that is inconsistent with these terms and conditions, except to the extent that
any term, provision or condition set forth in a purchase order expressly states
that it supersedes any term, provision or condition of this Agreement, unless it
is mutually agreed between the parties hereto.  If purchase orders are issued
less than [***] Business Days in advance of the desired shipment date,
Manufacturer shall make commercially reasonable efforts to meet Company’s
requirements, however Manufacturer’s failure to meet such requirements shall not
be deemed to be a breach of this Agreement.  In the event a purchase order is
issued less than [***] Business Days in advance of the desired shipment date,
Manufacturer shall advise Company within [***] Business Days whether such
purchase order can be fulfilled by the date requested in the purchase order and
the parties shall agree upon a delivery date of the requested Product.

3.             Prices and Payment.

3.1          Product Price.  The Product Price shall be fixed for the Initial
Period of this Agreement as specified in Exhibit A.

3.2          Purchase Price Adjustment.  Upon expiration of the Initial Period,
Manufacturer may adjust the Purchase Price of Product to reflect changes in
[***], subject to Section 4.1(b). Any such adjustment by Manufacturer shall be
notified to Company no less than [***] prior to expiration of the Initial
Period.  Upon commencement of the Second Period Company and Manufacturer agree
to meet [***] to formally review continuous improvement activities and other
improvements resulting from experience in operating the Manufacturing Process
including [***]. Company and Manufacturer shall work together to obtain process
improvements.  Net savings or increases in the [***] shall result in reductions
or increases respectively in the Purchase Price. [***] resulting from
Manufacturer’s efficient management of the Manufacturing Process shall not
result in reductions in the Purchase Price. Net increases in the cost of the
Manufacturing Process due to [***] shall result in increases in the Purchase
Price. Net savings in the product cost per unit achieved due to increases in the
[***] shall result in corresponding reductions in the Purchase Price.  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 Company and
Manufacturer.  In no event may Manufacturer increase the Purchase Price
following the Initial Period by [***].  The increase will be applicable on [***]
of every calendar year.

3.3          Invoices.  Upon acceptance by Manufacturer of a purchase order,
Manufacturer shall invoice Company for [***]%) of the estimated aggregate
Product Price for the purchase order (the “Reservation Fee”).  Not withstanding
the foregoing, however, the Parties agree that prior to completion of the
Initial Period, the Parties shall meet for the purpose of reconsidering the
percentage used to determine the Reservation Fee and shall, prior to the

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commencement of the Second Period, adjust such percentage, if necessary, upon
mutual written agreement. Upon completion of the manufacture of each purchase
order  and the submission of a Certificate of Analysis and Certificate of
Compliance duly approved by Manufacturer to Company for the batches of Product
manufactured for such purchase order Manufacturer shall refund Company the
Reservation Fee and invoice Company the Product Price for the quantity of
Product manufactured.

3.4          Cancellation Fee. If, after issuing a Purchase Order to the
Manufacturer for quantities which are in excess of  the minimum order quantities
defined in Section 2.2 for that Purchase Period and acceptance by the
Manufacturer of such Purchase Order, but before Manufacturer starts work to
manufacture for that Purchase Order, the Company subsequently cancels or
postpones its order, then Manufacturer shall have the right but not the
obligation to charge to Company [***]%) of the product price (“Cancellation
Fee”). If, after issuing a Purchase Order to the Manufacturer, the Company
subsequently cancels or postpones its order after the Manufacturer has started
work to manufacture for that Purchase Order, the Manufacturer shall be entitled
to charge to Company [***]%) of the Product Price for that Purchase Order.

3.5          Time for payments shall be of the essence. The Manufacturer
reserves the right to charge the lesser of either [***]% or the highest
percentage allowed under applicable law, per month on any overdue amount until
the date of payment in full save where part or whole payment is withheld by the
Company on a specific invoice as a result of a genuine dispute over that invoice
or part thereof.

3.6          Method of Payment; Currency. All payments due hereunder to
Manufacturer shall be paid to Manufacturer in [***] not later than [***] days
following the receipt of the applicable invoice, unless such shipment of Product
is rejected in accordance with the provisions of Section 5.3.  Company shall
make payment by telegraphic transfer to the account number 02140934 at HSBC.,
17-19 Regent Street, Wrexham, LL11 1RY, UK, Sort Code 40-47-26 or to such other
account of Manufacturer designated in writing to Company.  All currency amounts
referenced in this Agreement are to [***].

3.8          Effect of Certain Events.  In the event of termination or
expiration of this Agreement, Manufacturer shall provide reasonable assistance
to Company to implement the transfer of manufacturing responsibility for the
Product to Company or its designee.  Such reasonable assistance shall include
transfer of the Manufacturing Process as described in Section 7.7 but always
with the exception of Manufacturer Inventions subject to Section 7.2. In the
event of termination of this Agreement by Company pursuant to Section 9.2(a) or
(b) or 9.3(c), such reasonable assistance will be provided at Manufacturer’s
expense. In the event of any other termination or expiration of this Agreement,
Company shall pay Manufacturer’s reasonable and documented costs of providing
such assistance.  In the event of termination or expiration of this Agreement,
Manufacturer will promptly return to Company all unused Pramlintide Acetate Drug
Substance provided to Manufacturer pursuant to Section 4.1 hereof and Materials
paid for by Company as directed by and at the expense of Company.

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4.             Manufacturing.

4.1          Materials.

(a)           Except as stated in Section 4.1(b), Manufacturer will obtain any
Materials with the exception of Pramlintide Acetate Drug Substance required for
the manufacture of the Product, in reasonable quantities consistent with
Company’s most recent forecast for the Product. All Materials obtained by
Manufacturer pursuant to this Section 4.1(a) shall meet the specifications
stated in the Quality Agreement and Manufacturer shall order all Materials only
from vendors approved in advance by Company.  Manufacturer shall ensure all
Materials required to manufacture the Batch are released for use, in accordance
with Manufacturer’s quality system and requirements stated in the then current
Quality Agreement, prior to the manufacturing of the Batch. Company shall
reimburse the Manufacturer all the costs of all the Materials in stock or on
order on behalf of the Company by the Manufacturer, including QC testing costs
and disposal costs, if such Materials become redundant at any time if: (i)
Company makes a good faith determination not to continue with the
commercialization of Product, (ii) Company terminates this Agreement according
to Section 9.3(a), (iii) such materials expire due to insufficient demand for
Product, or (iv) such materials become obsolete due to a change of specification
advised by the Company; provided, however, Manufacturer shall use commercially
reasonable efforts to either utilize such materials in other areas of its
business or to return the materials, and Company shall not reimburse
Manufacturer for any such utilized or returned materials.  The orders of
Materials will be placed keeping in view the future forecasts and delivery lead
times. Manufacturer will maintain a safety stock level of at least [***]
calendar [***], but no more than [***] calendar [***] of approved Materials
unless the minimum procurement quantity for any Material provides sufficient
stocks for greater than [***] calendar [***].  For clarification purposes,
safety stock includes Materials needed to fulfill forecasts issued by Company
pursuant to Section 2.3.  Manufacturer and Company will review safety stock
levels on a quarterly basis and will mutually agree to make appropriate changes.

(b)           Company shall supply to Manufacturer, free of charge, freight and
duties prepaid and with transportation insurance paid by Company, quantities of
Pramlintide Acetate and Pramlintide Acetate reference standard sufficient to
enable Manufacturer to manufacture and perform agreed analytical testing of the
quantities of the Product ordered by Company.  Pramlintide Acetate will be
sampled according to the Quality Agreement and held by Manufacturer under
appropriate storage conditions until such time as it is required for manufacture
of Product. Manufacturer and Company agree that in the case of Product
manufactured prior to satisfactory completion of the first [***] commercial full
scale batches (including the process validation batches) of each of the
presentations of Product, Manufacturer shall make commercially reasonable
efforts to maximize yields but shall not be held liable for losses of
Pramlintide Acetate occurring as part of the Manufacturing Process. After
satisfactory completion of the first [***] commercial full scale batches of each
Product the parties shall meet to agree to a target yield for future production
(Target Yield). The Target Yield shall be defined as at least [***]%)] of the
average yield of the first [***] batches of each presentations of Product. For
clarity, “satisfactory completion” of a Batch will not include a Batch with
aberrant results.  All shipments of Pramlintide Acetate will be accompanied by a
Certificate of Analysis indicating the peptide content of such Pramlintide
Acetate and such other information as Company may specify and is to arrive
approximately thirty (30) days in advance of planned

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Product manufacture to allow for testing. Within fifteen (15) business days of
receipt of any Pramlintide Acetate hereunder, Manufacturer will verify the
quantity and identity of such shipment of Pramlintide Acetate according to test
methods approved and provided by Company and shall inspect the Pramlintide
Acetate in accordance with Manufacturer’s incoming material inspection
procedures.  If Manufacturer detects any discrepancies in the Pramlintide
Acetate in quantity or in the identity based on the identity testing performed,
Manufacturer shall inform Company immediately upon, but no later than five (5)
Business Days after, having detected such discrepancies.  Manufacturer shall
also inform Company of any obvious damage to the Pramlintide Acetate or
container received within five (5) Business Days of Manufacturer’s receipt
thereof.  Any rejected Pramlintide Acetate shall be returned at Company’s
expense and direction. Company shall make all final determinations if Materials
are suitable for use in Product manufacturing.

4.2          Manufacture of Product.  Manufacturer will manufacture and store
Product at the Facilities in accordance with the Quality Agreement, the
Specifications, applicable Regulatory Approvals, cGMPs and other Applicable
Laws, as then in effect.  Manufacturer shall not rework any Batch of the Product
without Company’ prior written consent, which consent shall not be unreasonably
withheld.  Manufacturer shall allow an employee of Company (and, with
Manufacturer’s prior consent, other persons) to be present during all
manufacturing of the Product. The Manufacturer shall perform quality control and
quality assurance testing to protocols and procedures agreed in writing between
the parties prior to shipment of Product to the Company. The Manufacturer shall
test a portion of each Batch manufactured for the Company prior to delivering
such Batch to the Company, and shall provide a Certificate of Analysis (i)
confirming that the Manufacturer followed the agreed methods for the testing of
such Product, (ii) containing the quality control and quality assurance test
results for such Batch and (iii) confirming that such Batch has been
manufactured in accordance with the Batch Records and cGMP. The Manufacturer
shall notify the Company immediately of any test failures noted in the
manufacture of Product.

4.3          Change in Specifications or Manufacturing Process.

(a)           Each party shall notify the other in advance of any proposed
changes in Specifications, release testing, stability testing, packaging,
Materials, equipment, facilities, processes or procedures used to manufacture
Product under this Agreement.  No changes in Specifications, release testing,
stability testing, packaging or the Materials, equipment, facilities, processes
or procedures used to manufacture Product under this Agreement, except changes
required by any applicable Regulatory Authority, will be made unless the parties
have agreed to such changes in writing prior to adoption of such changes. Any
such changes to the Product Specifications, release testing, stability testing,
packaging, Materials, equipment, facilities, processes or procedures used to
manufacture Product shall be handled in accordance with the procedures
established in the Quality Agreement, with costs paid as provided in
Section 4.3(b), (c) or (d), as applicable.

(b)           In the event Company requests any such changes be made, other than
changes described in Section 4.3(d), Manufacturer shall accommodate Company’s
requested changes to the extent technologically feasible.  If such changes would
result in material change in the cost of manufacture, then in that event the
Product Price may be suitably

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modified. If such changes require the purchase of capital equipment, such costs
and any related installation and qualification costs will be to the account of
the Company and such capital equipment shall be owned by the Company.

(c)           In the event Manufacturer requests any such changes be made, other
than changes described in Section 4.3(d), and such changes would result in a
material increase in Manufacturer’s cost of manufacture, all costs reasonably
required in connection with such changes shall be paid as mutually agreed by the
parties.

(d)           In the event changes are requested by a Regulatory Authority or
required to bring either of the Facilities into compliance with Applicable Laws,
or additional changes, activities, or manufacturing is required to bring the
Manufacturing Process into compliance with Applicable Laws, Specifications or
other Product Requirements, Manufacturer shall accommodate such changes to the
extent technologically feasible, and all costs reasonably required in connection
with such changes, activities, or manufacturing shall be borne by the
Manufacturer.  In such an event the Product Price may be suitably revised to
accommodate such changes.

4.4          Regulatory Matters.

(a)           Manufacturer shall provide to Company such documentation, data and
other information relating to the Facilities, Product, or Manufacturer’s
Manufacturing Processes and procedures for Product as Company may request for
submission to Regulatory Authorities.

(b)           Company shall be responsible for all filings necessary for
Regulatory Approvals.  The parties agree that Company shall be the sole and
exclusive owner of all right, title and interest in and to all Drug Approval
Applications and Regulatory Approvals related to the Product in the United
States and any OUS Country. Manufacturer shall assist Company in the preparation
of all documents necessary to effectuate Company’s rights in all Drug Approval
Applications and Regulatory Approvals related to the Product and agrees to
transfer, effect, confirm, perfect, record, preserve, protect and enforce all
rights, title and interests transferred hereunder, at the reasonable request and
expense of Company. Manufacturer will use commercially reasonable efforts to
assist Company in obtaining such Regulatory Approvals. For the avoidance of
doubt, Company has sole responsibility for the content of all Drug Approval
Applications.  This Agreement automatically terminates if Amylin terminates
development of the Product following final rejection of the Product by the FDA.

4.5          Compliance with Quality Agreement and Applicable Laws.  The parties
shall comply with the terms and conditions of the Quality Agreement.
Manufacturer shall comply with all Applicable Laws with respect to activities
under this Agreement.   Manufacturer represents and warrants to Company that it
has and will maintain during the Term all establishment licenses and permits,
including without limitation health, safety and environmental permits, necessary
for the conduct of Manufacturer’s activities under this Agreement.

4.6          Manufacturer Facilities.  Manufacturer warrants and represents that
it has, and will maintain, all licenses, permits and approvals necessary to
fulfill its obligations

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under this Agreement.  Manufacturer covenants to design and operate the
facilities it uses to manufacture, package, test, or store Product to
successfully pass inspections conducted by regulatory authorities. Manufacturer
agrees to maintain appropriate security measures at its facilities no less
stringent than measures that are customary in the pharmaceutical industry.

4.7          QA Audits. Upon written notice of no less than [***] Business Days
for routine audits to Manufacturer, Company shall have the right to have
representatives visit the Facilities during normal business hours to review
Manufacturer’s manufacturing operations, assess its compliance with cGMPs and
quality assurance standards, and discuss any related issues with Manufacturer’s
manufacturing and management personnel.  Manufacturer shall maintain the
Facilities in accordance with cGMPs.  Manufacturer’s failure to correct any cGMP
deficiency regarding any aspect of Manufacturer’s manufacture within a
reasonable time period after notice of such deficiency shall be a material
breach of this Agreement. Upon reasonable notice, the Manufacturer will allow
employees of the Company access to the Facility, documentation, and personnel to
audit and for observation of the production process and quality control testing
of the Product, disposal of waste and adherence to cGMP requirements and this
Agreement. During such inspections, employees of the Company (number of persons
should be restricted to not more than [***]) shall have the right to audit any
aspect of the Manufacturers manufacture of Product, and such audit may include,
without limitation, verification of Manufacturers maintenance of drug
establishment registrations with the FDA and other applicable Regulatory
Authorities, and review of conditions and documentation of any aspect of
manufacture of Product.

4.8          Regulatory Inspections. Manufacturer agrees to permit the FDA and
other Regulatory Authorities to inspect any aspect of Manufacturer’s manufacture
and testing of the Product including, without limitations, any pre-approval
inspection (“PAI”). Manufacturer shall cooperate with Company, and with any
Regulatory Authority, as necessary to facilitate prompt approvals by such
Regulatory Authority of the Manufacturing Process or testing process for the
Product, including preparation and submission of necessary data relating to the
manufacturing or testing processes, including without limitation any PAI or
subsequent inspection. Manufacturer shall notify Company if either or both of
the Facilities are the subject of an inspection by any Regulatory Authority or
any compliance inspection relating to, or that could reasonably be expected to,
affect the manufacture or storage of the Product or its production at the
Facilities. Manufacturer shall provide such notification, by telephone and fax,
as soon as Manufacturer becomes aware of the inspection, but not later than two
(2) Business Days from the time Manufacturer becomes aware of the inspection. In
connection with any such inspection, including without limitation a PAI,
Manufacturer shall allow employees or representatives of Company to be present
during the inspection. Manufacturer shall allow Company to participate in the
formulation of any response to regulatory inspections or any other issues raised
by any Regulatory Authority related to Product. Manufacturer will also
simultaneously provide Company with photocopies of any responses provided to any
Regulatory Authority, including, without limitation, responses to any FDA 483 or
similar reports. Manufacturer shall keep Company fully informed as to any
Manufacturer communication with any Regulatory Authority related to Product.

4.9          Investigation of Failed Batch.  Manufacturer shall investigate, and
cooperate fully with Company in investigating any Batch that fails to meet the
Product

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Requirements or that incurs a significant deviation from expected Manufacturing
Process.  Manufacturer shall keep Company informed of the status of any
investigation and, upon completion of the investigation, shall provide Company
with a final written report describing the cause of the failure or deviation and
summarizing the results of the investigation.

4.10        Documentation. Manufacturer shall keep complete, accurate and
authentic accounts, notes, data and records of the work performed under this
Agreement, including, without limitation, master production and control records
and Product complaint files, in accordance with Applicable Laws.  In addition,
Manufacturer shall retain and store samples of each Batch only as required by
Applicable Laws.  The sample size shall be twice the size necessary to conduct
quality control testing. Manufacturer shall retain such records and samples for
the periods required by Applicable Laws. Upon Company’s request, Manufacturer
shall make available copies of such records and portions of the samples to
Company.  After such time period, Manufacturer shall notify Company prior to
destroying such records and samples and, at Company’s request and expense, shall
provide copies of such records and any remaining samples to Company.  The
Manufacturer shall not be obliged to retain any samples thereafter and after due
intimation to the Company, the Manufacturer shall destroy the remaining samples.

4.11        Complaints and Adverse Reaction.  Each party shall promptly advise
the other of any complaints, adverse reaction reports, safety issues or toxicity
issues relating to Product of which it becomes aware, which may be the result
of, or have an effect on, the manufacturing or packaging operations performed by
Manufacturer. Company shall be responsible for all reporting of such information
to Regulatory Authorities.

4.12        Labeling; Trademark.  Manufacturer shall affix labeling to the
Product as directed by Company.  Nothing in this Agreement gives Manufacturer
the right to use any trademark or trade name of Company except as specified in
writing by Company.  Manufacturer shall not affix any label, stamp or other mark
identifying Manufacturer as the source of the Product except as instructed in
writing by Company or as may be required by Applicable Laws.

5.             Delivery and Acceptance.

5.1          Delivery.  Unless otherwise agreed by the parties in writing, all
shipments shall be shipped FCA (Incoterms 2000) the Facilities by air freight to
the destination specified by Company in the applicable purchase order.
Manufacturer shall make each shipment of the Product in the quantity, cartridge
size and on the shipment date specified for it on Company’s purchase order, via
the mode(s) of transportation and to the party and destination specified on such
purchase order. Manufacturer will package and ship the Product in accordance
with Manufacturer’s customary practices for pharmaceutical products, unless
otherwise specified by Company.  Manufacturer shall deliver Product ordered by
Company on the scheduled delivery dates set forth in the relevant purchase
orders, subject to the provisions of Section 2.4.  If Company is not ready to
accept shipment of Product on the date Manufacturer is prepared to ship Product,
then Manufacturer shall store Product in a manner consistent with customary
practices for pharmaceutical products and Company shall pay Manufacturer a
commercially reasonable storage fee.  Company and Manufacturer agree to
negotiate the amount of such storage fee in good faith.

 

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5.2          Title. Title to all Pramlintide Acetate shall at all times remain
in Company.  Title to all Materials other than Pramlintide Acetate, work in
progress to produce Product, and all completed Product (except Pramlintide
Acetate contained therein) shall remain with Manufacturer until delivery of such
Product to carrier designated by the Company.  Notwithstanding the foregoing,
and regardless of whether delivery of Product to Company has occurred under
Section 5.1, Manufacturer shall bear all risk of loss with respect to, and shall
insure, all Product until transfer by Manufacturer to a carrier for shipment as
directed by Company in the applicable purchase order.

5.3          Acceptance and Rejection.

(a)           Concurrent with the delivery of any Batch, Manufacturer shall
provide Company with all documentation required to be provided to Company under
the Quality Agreement, including, without limitation, a Certificate of Analysis
and Certificate of Compliance for such Batch.  Company may reject delivery of
any Batch that does not conform with the Product Requirements.  Any such notice
of rejection shall be in writing and shall indicate the reasons for such
rejection.

(b)           In order to reject delivery of a Batch, Company must give written
notice to Manufacturer of Company’ rejection of any delivery within [***] days
after receipt of such delivery.  If no such notice of rejection is received,
Company shall be deemed to have accepted such delivery of the Batch [***] days
after delivery of the Batch, except in the case of Hidden Defects.  If Company
discovers in a Batch a Hidden Defect, such as a Contaminant, at any time after
acceptance of such Batch, Company shall notify Manufacturer within [***] days of
discovering such Hidden Defect and shall have the right to reject the Batch
under the procedures regarding rejection set forth in Section 5.3(c), (d) and
(e), as applicable.

(c)           After notice of rejection is given, Company shall cooperate with
Manufacturer in determining whether rejection is justified.  Manufacturer shall
notify Company as promptly as reasonably possible (and in any event within [***]
days after notice of rejection from Company) if Manufacturer does not agree that
such rejection is justified.  If no such notice from Manufacturer is received,
Manufacturer shall be deemed to agree that such rejection is justified. Should
Company reject any Batch and Manufacturer agree that such rejection is justified
or if applicable, a third party determines such rejection is justified pursuant
to the provisions of Section 5.3(d), Manufacturer shall (i) reimburse amounts
paid to Manufacturer by Company pursuant to Section 3.1. and (ii) shall
manufacture and supply the next Batch of Product ordered by Company at no cost
to Company.  Compliance with the provisions of this Section 5.3(c) and 5.3(d)
and 5.3(e) shall be Manufacturer’s sole liability to Company where Company
rejects a Batch of and either Manufacturer agrees, or a third party determines
under Section 5.3(d), that such rejection is justified, subject only to
Section 10.4.

(d)           If Manufacturer in good faith disagrees with Company’s
determination that rejection of a Batch is justified, certain of the Product in
such Batch shall be submitted to a mutually acceptable third party laboratory or
expert. Such third party shall determine whether such Product meets the
Specifications, and the parties agree that such third party’s determination
shall be final and determinative. The party against whom the third party
tester/expert rules shall bear all costs of the third party testing.  Whether or
not Manufacturer

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accepts Company’s basis for rejection, promptly on receipt of a notice of
rejection of a Batch, Manufacturer shall replace such rejected Batch within
[***] days.  If the third party tester/expert rules that the Batch meets
Specifications and those warranties pursuant to Sections 8.3 (a), (b), (c), (d)
and (e), Company shall purchase that Batch at the agreed-upon price,
irrespective of whether Manufacturer has already replaced it. All replacement
Product shall be invoiced as well and Company shall pay for such Product as
otherwise provided under the terms of this Agreement. If third party
tester/expert agrees that rejection was justified then Manufacturer shall (i)
reimburse Company amounts paid by Company pursuant to Section 3.1 and (ii) shall
manufacture and supply the next Batch of Product ordered by Company at no cost
to Company. Compliance with the provisions of this Section 5.3(d) and payment of
the costs in Section 5.3(e) shall be Manufacturer’s sole only liability to
Company where Company rejects a Batch of and either Manufacturer agrees, or a
third party determines under Section 5.3(d), that such rejection is justified,
subject only to Section 10.4. Manufacturer shall have no further liability to
the Company in respect of such Batch except to what is stated herein.

(e)           Company may not destroy any Batch until [***] days after rejection
unless, prior to that date, Company receives written notification from
Manufacturer that Manufacturer does not agree that such rejection is justified
or that Manufacturer requests return of such rejected Batch.  Company shall
destroy such rejected Batch promptly at Manufacturer’s cost and provide
Manufacturer with certification of such destruction.  Company shall, upon
receipt of Manufacturer’s request for return, promptly return such Batch to
Manufacturer, at Manufacturer’s cost.

5.4          Recalls and Similar Actions.

(a)           If there is a recall, withdrawal or field correction with respect
to, or any governmental seizure of, Product (“Recall Action”), which Recall
Action is considered by the Company to be due in part to a failure of the
Manufacturer to comply with its warranties stated in Section 8.3 of this
Agreement then Company will notify Manufacturer promptly of the details
regarding such Recall Action, including providing copies of all relevant
documentation concerning such Recall Action. Manufacturer will assist Company in
investigating any such Recall Action, if Company so requests, and all regulatory
contacts that are made and all activities concerning such Recall Action will be
initiated and coordinated by Company with Manufacturer’s involvement and
assistance, as reasonably requested by Company.

(b)           If any Recall Action occurs which is considered by the Company to
be due in part to a failure of the Manufacturer to comply with its warranties
stated in Section 8.3 of this Agreement and Manufacturer agrees with said
consideration then Manufacturer shall, to the extent and only to the extent of
its relative responsibility, bear the cost and expense of any such Recall
Action. Therefore, if both Manufacturer and Company contribute to the cause of
such a Recall Action, the cost and expense thereof will be shared in proportion
to each party’s contribution to the problem.

(c)           If any Recall Action occurs which is considered by the Company to
be due in part to a failure of the Manufacturer to comply with its warranties
stated in Section 8.3 of this Agreement and Manufacturer disagrees with said
consideration then the parties shall refer to a mutually acceptable third party
expert. Such third party shall determine if Manufacturer

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has complied with its warranties stated in Section 8.3. If such a determination
is made Manufacturer shall have no liability towards the cost and expense of the
Recall Action. If the third party determines Manufacturer has not complied with
its warranties stated in Section 8.3 Manufacturer shall, to the extent and only
to the extent of its relative responsibility, bear the cost and expense of any
such Recall Action.

6.             Protection of Confidential Information.

6.1          Confidentiality.  During the Term and for a period of ten (10)
years thereafter, each party (the “Receiving Party”) agrees with respect to any
Confidential Information of the other party (the “Disclosing Party”):

(a)           To use such Confidential Information only for the purposes set
forth in this Agreement;

(b)           To receive, maintain and hold the Confidential Information in
confidence;

(c)           Not to disclose, or authorize or permit the disclosure of, any
Confidential Information to any third party without the prior written consent of
the Disclosing Party; and

(d)           Except as needed to fulfill its obligations hereunder, to return
any Confidential Information to the Disclosing Party at the request of the
Disclosing Party and to retain no copies or reproductions thereof.

6.2          Limitations.  The Receiving Party shall not be obligated to treat
as Confidential Information, information that the Receiving Party can show by
competent written evidence:

(a)           was already known to the Receiving Party without any obligations
of confidentiality prior to receipt from the Disclosing Party;

(b)           was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving Party;

(c)           became generally available to the public or otherwise part of the
public domain after its disclosure, other than through any act or omission of
the Receiving Party in breach of any obligation of confidentiality;

(d)           was disclosed to the Receiving Party, other than under an
obligation of confidentiality, by a third party who had no obligation not to
disclose such information to others; or

(e)           was independently discovered or developed by the Receiving Party
without the use of the Disclosing Party’s Confidential Information.

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6.3          Authorized Disclosure.  Notwithstanding Section 6.1, the Receiving
Party may disclose Confidential Information, without violating the obligations
of this Agreement, to the extent the disclosure is required by Applicable Laws
or a valid order of a court or other governmental body having jurisdiction;
provided that the Receiving Party gives reasonable prior written notice to the
Disclosing Party of such required disclosure and makes a reasonable effort to
obtain, or to assist the Disclosing Party in obtaining, a protective order
preventing or limiting the disclosure and/or requiring that the Confidential
Information so disclosed be used only for the purposes for which the law or
regulation requires, or for which the order was issued.  Further, the Receiving
Party may disclose Confidential Information of the Disclosing Party solely to
the extent (a) such disclosure is reasonably necessary in advising investors and
the investment community of the results of the research, development or
commercialization activities hereunder (subject to the prior written consent of
the Disclosing Party, which consent will not be unreasonably withheld), or
(b) such disclosure is made to Affiliates, employees, consultants or agents to
other third parties in connection with due diligence by such Third Parties, or
to potential third party investors in confidential financing documents,
provided, in each case, that any such Affiliate, employee, consultant, agent or
third party is subject to confidentiality and non-use obligations with respect
to such information.

6.4          Use of Name/Publicity.  Neither party shall use the other party’s
name in connection with any publication or promotion without the other party’s
written consent, except as required by federal, state or local laws, rules and
regulations.  Manufacturer shall not disclose the specific content or terms of
this Agreement without the prior written consent of Company.

7.             Intellectual Property Rights.

7.1          Company Inventions.  All right, title and interest in and to any
intellectual property rights in Pramlintide Acetate and Product shall at all
times be and remain the sole and exclusive property of Company.  Company shall
solely own, and shall alone have the right to apply for patents, patent rights
and inventor’s certificates, on any invention, method, process, discovery or
know-how (whether or not patentable) which is conceived solely by Company, its
consultants or agents (other than Manufacturer) in the performance of this
Agreement (“Company Inventions”).

7.2          Manufacturer Inventions.  Manufacturer shall solely own, and shall
alone have the right to apply for patents, patent rights and inventor’s
certificates, on any invention, method, process, discovery or know-how (whether
or not patentable) which is conceived solely by Manufacturer, its consultants or
agents in the performance of this Agreement (“Manufacturer Inventions”).

7.3          Joint Inventions.  Any invention, method, process, discovery or
know-how (whether or not patentable) not conceived solely by either Company and
Manufacturer or their respective consultants or agents during the performance of
this Agreement (“Joint Inventions”) shall be jointly owned by Company and
Manufacturer.  The law of joint ownership of patents of the United States shall
apply to joint ownership of any Joint Inventions inside and outside of the
United States. Where appropriate, the parties may engage outside counsel
agreeable to both parties (the costs of which shall be borne equally by the
parties) to represent

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them jointly in the prosecution of patent applications and the maintenance of
patents with respect to Joint Inventions.

7.4          Prosecution.  Should either party not wish to file, prosecute,
maintain or issue a patent application or maintain a patent covering such
party’s interest in a Joint Invention, then such party  (the “Granting Party”)
shall, at the other party’s election, grant to the other party (i) a perpetual,
irrevocable, exclusive (even as to the Granting Party and its Affiliates),
worldwide, fully paid-up royalty-free license under the Granting Party’s
interest in the Joint Invention, with the right to grant sublicenses, to
develop, make, have made, use, import, offer to sell, have sold and sell
products, and (ii) any necessary authority to file, prosecute, maintain and
issue such a patent application or maintain such a patent, all at the expense of
the party requesting that such filing be made or action be taken.

7.5          Assistance.  Upon request, Company and Manufacturer shall each
provide the other with reasonable assistance in obtaining patents and, if
necessary, enforcing patent rights in Manufacturer Inventions, Company
Inventions or Joint Inventions, as applicable.  To that end, each party agrees
to assist the other in executing, verifying and delivering such documents and
performing such acts as may be reasonably requested by the other party in
applying for, obtaining, perfecting, evidencing, sustaining or enforcing the
other party’s rights in Manufacturer Inventions, Company Inventions or Joint
Inventions, as applicable.  The party requesting such assistance shall reimburse
the assisting party for all reasonable out-of-pocket expenses incurred and
provide reasonable compensation for time spent in providing such assistance,
except in the case of any patent covered by a Joint Invention, in which case no
compensation shall be provided and all expenses shall be [***] by the parties
(i.e., [***]% paid by Company and [***]% paid by Manufacturer).

7.6          Infringement.  Each party shall promptly notify the other of any
potential alleged or threatened infringement of patents claiming any Company
Invention, Manufacturer Invention or Joint Invention, or of any allegation by a
third party of which it becomes aware that the activity of Company or
Manufacturer pursuant to this Agreement infringes a third party’s patent rights.

7.7          Manufacturing Process License; Technology Transfer.  Manufacturer
hereby grants Company a perpetual, irrevocable, exclusive, worldwide,
royalty-free, fully paid-up license, with the right to sublicense, to all of
Manufacturer’s rights in and to the Manufacturing Process, including any
Manufacturer Inventions, to use,  import, make, have made, offer to sell, have
sold and sell Product or any other product containing Pramlintide Acetate;
provided, however, if Company or any sublicensee of Company or any successor
business or assignee wishes Manufacturer to assist in the transfer of the
Manufacturing Process to another manufacturer, Manufacturer shall have the right
to charge a commercially reasonable fee based on FTE rates for providing
training and other assistance requested by such party in connection with such
technology transfer.  Notwithstanding the foregoing, if any such transfer of the
Manufacturing Process to a third party results in a transfer of the
Manufacturer’s Technology, the parties agree to meet for the purpose of
determining the appropriate royalty amount to be paid to the Manufacturer.

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8.             Representations and Warranties.

8.1          No Inconsistent Obligations.  Each party represents and warrants
that the terms of the Agreement are not inconsistent with its other contractual
arrangements or obligations.

8.2          Due Authorization.  Each party represents and warrants that (a) it
has full power and authority to enter into this Agreement, (b) this Agreement
has been duly authorized by it, and (c) this Agreement is binding upon it.

8.3          Product Warranties.  Manufacturer represents and warrants that
Product delivered hereunder will:

(a)           be manufactured by Manufacturer in accordance with cGMPs and
relevant Regulatory Approvals;

(b)           conform to the Specifications at the time of delivery;

(c)           not contain any Contaminant or be adulterated within the meaning
of the FDCA or any other Applicable Law in which the definitions of adulteration
are substantially the same as those contained in the FDCA, as such laws are
constituted and effective at the time of delivery;

(d)           not be an article which may not, under the provisions of
Sections 404, 505 of 512 of the FDCA, be introduced into interstate commerce;
and

(e)           be free and clear of any lien or encumbrance.

Company’s remedies and Manufacturer’s liability with respect to the warranties
set forth in this Section 8.3 are set forth in Section 5.3(d) above.

8.4          The Company represents, warrants and agrees that:

a)             The manufacture of Product as contemplated herein, will not, to
the Company’s knowledge, infringe any existing patents or any other proprietary
rights of third parties, and as of the date hereof Company has not received any
notice of any claimed infringement (including without limitation patent
infringement) in connection with Pramlintide Acetate.

b)            The Company, to the Company’s knowledge, and its employees have
never been debarred or convicted of a crime for which a person can be debarred,
under subsection (a) or (b) of 21 U.S.C. § 335a, as amended, and Company agrees
that it does not now and does not intend in the future to use in any capacity
the services of any person debarred under subsection (a) or (b) of 21 U.S.C.
§335a, as amended.  If, during the term of this Agreement, Company or any other
person performing under this Agreement becomes debarred or disqualified, or
receives notice of an action or threat of an action with respect to debarment or
disqualification, Company shall promptly notify Manufacturer.

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8.5          No Debarred or Disqualified Persons. Manufacturer represents and
warrants that it is not currently and it shall not employ, contract with, or
retain any person directly or indirectly to perform any services under this
Agreement if such a person (a) is under investigation by the FDA for debarment
or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its
successor provisions or any regulations promulgated thereunder, (b) has a
disqualification hearing pending or has been disqualified by the FDA pursuant to
21 CFR § 312.70 or its successor provisions or (c) is subject to similar
investigation or disqualification pursuant to any other relevant regulatory
authority.  In addition, Manufacturer represents and warrants that it has not
engaged in any conduct or activity which could lead to any of the
above-mentioned disqualification or debarment actions.  If, during the Term,
Manufacturer or any person employed or retained by it to perform any services
under this Agreement (i) comes under investigation by the FDA for a debarment
action or disqualification, (ii) is debarred or disqualified, or (iii) engages
in any conduct or activity that could lead to any of the above-mentioned
disqualification or debarment actions, Manufacturer shall immediately notify
Company of same.

8.6          Disclaimer.  Except as set forth above, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND
EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGMENT,
MERCHANTIBILITY, AND FITNESS FOR A PARTICULAR PURPOSE.

8.7          Limitation of Liability.  NEITHER PARTY SHALL BE ENTITLED TO
RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER. 
This Section 8.7 shall not be construed to limit either party’s indemnification
obligations under Section 10 or to limit remedies available for breach of
confidentiality and non-use obligations or for infringement or misappropriation
of intellectual property rights.

9.             Term and Termination.

9.1          Term.  The term of this Agreement shall commence on the Effective
Date and, unless terminated earlier as provided herein, shall continue until the
expiration of the Fifth Period, subject to renewal by mutual written agreement
of the parties (the “Term”).

9.2          Termination by Either Party.  A party may terminate this Agreement:

(a)           for material breach of this Agreement by the other party upon
sixty (60) days’ written notice specifying the nature of the breach, if such
breach has not been cured within such sixty (60) day period; provided, this
Agreement may be terminated immediately if the breach is incapable of remedy or
has not been corrected by the breaching party within sixty (60) days after
written notice; or

(b)           immediately upon written notice to the other party, if the other
party makes a general assignment for the benefit of creditors, files an
insolvency petition in bankruptcy, petitions for or acquiesces in the
appointment of any receiver, trustee or similar

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officer to liquidate or conserve its business or any substantial part of its
assets, commences under the laws of any jurisdiction any proceeding involving
its insolvency, bankruptcy, reorganization (other than a reorganization without
insolvency), dissolution, liquidation or any other similar proceeding for the
release of financially distressed debtors or becomes a party to any proceeding
or action of the type described above and such proceeding or action remains
undismissed or unstayed for a period of more than sixty (60) days.

9.3          Termination by Company.  Company may terminate this Agreement:

(a)           at any time after the expiration of the Fifth Period upon one (1)
year’s prior written notice to Manufacturer;

(b)           at any time prior to the Launch Date in the event that Company
makes a good faith determination that it will not continue with the
commercialization of Product, upon at least sixty (60) days prior written notice
to Manufacturer, and such termination shall be effective at the end of such
sixty (60) day period; provided that Company shall remain obligated to pay for
Product ordered under any purchase orders issued by Company to Manufacturer
prior to such effective termination date.

(c) immediately upon written notice to Manufacturer if Manufacturer (i)  has its
manufacturing authorizations for the Product suspended or withheld (ii) in the
case of a PAI, fails to pass an inspection by a Regulatory Authority (iii) in
the case of a regulatory inspection by a Regulatory Authority fails to pass an
inspection and has not taken, within one hundred (100) Business Days, such
action as is necessary to correct the items cited by the Regulatory Authority.

9.4          Automatic Termination. In the event Company notifies Manufacturer
that it has terminated development of Pramlintide Acetate following the receipt
by Company of notice of final rejection by the FDA for marketing authorization
for commercial sale and distribution of Product in the United States, then this
Agreement shall automatically terminate.

9.5          Survival Upon Termination. Expiration or termination of this
Agreement will not relieve the parties of any obligation accruing prior to such
expiration or termination. Sections 1, 3.8, 4.7, 4.10, 6, 7, 8.3, 8.5, 8.7, 9.5,
9.6, 10, 11 and 12 will survive termination of this Agreement.

9.6          Remedies.  In the event of any breach of any provision of this
Agreement, in addition to the termination rights set forth herein, each party
shall have all other rights and remedies at law or equity to enforce this
Agreement.

10.          Indemnification.

10.1        By Company.  Company agrees to indemnify, defend and hold harmless
Manufacturer and its Affiliates and their respective officers, employees and
agents (“Manufacturer Indemnitees”) from any loss, expense (including reasonable
legal counsel fees and expenses), cost, liability or damages (“Losses”) incurred
by any Manufacturer Indemnitee as

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a result of any claim, demand, action or other proceeding by any third party
(“Claim”) arising out of or related to (a) Company’s breach of any
representation or warranty made by Company in this Agreement or (b) the
handling, possession, storage or use of Product by or on behalf of Company
following delivery by Manufacturer to Company, except to the extent Manufacturer
is obligated to indemnify Company with respect to such Losses under Section 10.2
or the Losses are based on the negligence or willful misconduct of any
Manufacturer Indemnitee.  Manufacturer Indemnitees shall promptly and in any
event within thirty (30) days notify Company of any known Claim which is the
subject of Losses.  Manufacturer Indemnitees shall fully cooperate with Company
in the defense or settlement of any claim of Losses under this Section 10.1;
provided, however, that no Manufacturer Indemnitee shall be required to admit
fault or responsibility in connection with any settlement.  Manufacturer
Indemnitees shall have the right to select and to obtain representation by
separate legal counsel at its own expense.

10.2        By Manufacturer.  Manufacturer shall indemnify, defend and hold
harmless Company and its Affiliates and their respective officers, employees and
agents (“Company Indemnitees”) from and against any and all Losses to which any
Company Indemnitee may become subject as a result of any Claim arising out of or
related to (a) Manufacturer’s breach of any representation or warranty made by
Manufacturer in this Agreement or (b) the handling, possession, storage or use
of Pramlintide Acetate or Product by or on behalf of Manufacturer prior to
delivery of Product by Manufacturer to Company, except to the extent Company is
obligated to indemnify Manufacturer with respect to such Losses under
Section 10.1 or the Losses are based on the negligence or willful misconduct of
any Company Indemnitee.  Company Indemnitee shall promptly and in any event
within thirty (30) days notify Manufacturer of any known Claim which is the
subject of Losses.  Company Indemnitees shall fully cooperate with Manufacturer
in the defense or settlement of any claim of Losses under this Section 10.2;
provided, however, that no Company Indemnitee shall be required to admit fault
or responsibility in connection with any settlement.  Company Indemnitees shall
have the right to select and to obtain representation by separate legal counsel
at Company’s own expense.

10.3        Loss of Pramlintide Acetate Drug Substance.  If any Pramlintide
Acetate Drug Substance is destroyed, damaged or lost while in Manufacturer’s
custody, control or storage prior to its use in the manufacture of the Product,
Manufacturer’s liabilities shall be determined at a rate of [***] US dollars
($[***]) per gram] of Pramlintide Acetate Drug Substance and limited to a
maximum of [***] US dollars ($[***]) for each individual incidence of loss.  For
the avoidance of doubt Manufacturer shall not be liable for loss of Pramlintide
Acetate Drug Substance if peptide content has deteriorated and Manufacturer has
complied fully with the storage requirements for Pramlintide Acetate Drug
Substance as specified by Company.

10.4        Restriction on Limitation of Liability.  Nothing in this Agreement
shall limit a party’s liability in respect of death or personal injury caused by
the negligence of that party or its liability in respect of fraudulent
misrepresentation.

11.          Dispute Resolution

11.1        Discussions Between the Parties.  If any claim, dispute, or
controversy of whatever nature arising out of or relating to this Agreement,
including, without limitation, any action or claim based on tort, contract, or
statute (including any claims of breach or violation of

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statutory or common law protections from discrimination, harassment and hostile
working environment), or concerning the interpretation, effect, termination,
validity, performance and/or breach of this Agreement (“Disputed Claim”), arises
between the parties and the parties cannot resolve the dispute within thirty
(30) days of a written request by either party to the other party, the parties
agree to hold a meeting, attended by the an executive officer or their
equivalent of Company and Manufacturer, to attempt in good faith to negotiate a
resolution of the dispute prior to pursuing other available remedies.  If,
within sixty (60) days after such written request, the parties have not
succeeded in negotiating a resolution of the dispute, such dispute shall be
resolved by final and binding arbitration in accordance with Section 11.2.

11.2        Arbitration.

(a)           Arbitration of Disputed Claims between the parties under this
Section 11.2 shall be conducted in accordance the Rules of the International
Chamber of Commerce, Court of Arbitration, Paris (the “ICC”), except to the
extent the provisions of this Section 11.2 conflict with such Rules, in which
case the provisions of this Section 11.2 shall prevail.

(b)           The arbitration shall be conducted by three (3) arbitrators who
shall be knowledgeable in the subject matter which is at issue in the dispute
and have no current or past affiliation with either party or their respective
Affiliates.  Each party shall select one of the arbitrators within thirty (30)
days after notice of arbitration under this Section 11.2, and the third
arbitrator, who shall act as the Chair of the arbitration, shall be appointed by
the ICC.

(c)           The arbitrators shall determine what discovery will be permitted,
consistent with the goal of limiting the cost and time that the parties must
expend for discovery; provided that the arbitrators shall permit such discovery
as the arbitrators deem necessary to permit an equitable resolution of the
dispute.  The arbitrators shall have sole discretion with regard to the
admissibility of any evidence.

(d)           No later than ninety (90) days after the arbitrators are selected
(or such other period of time as agreed to by the parties in writing), the
arbitrators will hold the arbitration hearing to resolve each of the issues
identified by the parties.  The arbitrators may conduct additional arbitration
hearings if the arbitrators deem appropriate; provided that all arbitration
hearings will be completed by no later than one hundred twenty (120) days after
the arbitrators are selected (or such other period of time as agreed to by the
parties in writing).  Each party will have the right to be represented by
counsel at any such arbitration hearing.  The arbitration hearings shall be held
in London, England.

(e)           The arbitration will be confidential and the arbitrators will
issue appropriate protective orders to safeguard each party’s Confidential
Information.  Except as required by law, no party will make (or instruct the
arbitrators to make) any public announcement with respect to the proceedings or
decision of the arbitrators without the prior written consent of the other
party.  The existence of any Disputed Claim, and the award of the arbitrators,
will be kept in confidence by the parties and the arbitrators, except as
required in connection with the enforcement of such award or as otherwise
required by applicable law.

 

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(f)            The arbitrators shall, within thirty (30) days after the
conclusion of the arbitration hearings, issue a written award and statement of
decision describing the essential findings and conclusions on which the award is
based, including the calculation of any damages awarded.  The arbitrators shall
be authorized to award compensatory damages, but shall NOT be authorized to (i)
award non-economic damages, such as for emotional distress, pain and suffering
or loss of consortium, (ii) award punitive damages, or (iii) reform, modify or
materially change this Agreement or any other agreements contemplated hereunder;
provided, however, that the damage limitations described in subsections (i) and
(ii) of this sentence will not apply if such damages are statutorily imposed. 
The arbitrators also shall be authorized to grant any temporary, preliminary or
permanent equitable remedy or relief they deem just and equitable and within the
scope of this Agreement, including, without limitation, an injunction or order
for specific performance. The decision of the arbitrators shall be final and
binding upon the parties.  Judgment on the award rendered by the arbitrators may
be entered in any court having competent jurisdiction thereof.  Nothing herein
shall limit or restrict a party’s ability to seek injunctive or other equitable
relief in the event of a breach or anticipated breach of Section 6.

(g)           Each party has the right before or during the arbitration to seek
and obtain from the appropriate court provisional remedies, such as attachment,
preliminary injunction or replevin, to avoid irreparable harm, maintain the
status quo, or preserve the subject matter of the arbitration.  This Section
11.2 shall not apply to any dispute, controversy or claim that concerns (i) the
validity or infringement of a patent, trademark or copyright; or (ii) any
antitrust, anti-monopoly or competition law or regulation, whether or not
statutory.

11.3        Costs and Awards.  Each party shall bear its own attorneys’ fees,
costs, and disbursements arising out of the arbitration, and shall pay an equal
share of the fees and costs of the arbitrators; provided, however, that the
arbitrators shall be authorized to determine whether a party is the prevailing
party, and if so, to award to that prevailing party reimbursement for its
reasonable attorneys’ fees, costs and disbursements (including, for example,
expert witness fees and expenses, photocopy charges, travel expenses, etc.),
and/or the fees and costs of the arbitrator.  Absent the filing of an
application to correct or vacate the arbitration award under California Code of
Civil Procedure Sections 1285 through 1288.8, each party shall fully perform and
satisfy the arbitration award within fifteen (15) days of the service of the
award.

11.4        Waiver and Acknowledgment.  By agreeing to this binding arbitration
provision, the parties understand that they are waiving certain rights and
protections which may otherwise be available if a Disputed Claim between the
parties were determined by litigation in court, including, without limitation,
the right to seek or obtain certain types of damages precluded by this
provision, the right to a jury trial, certain rights of appeal, and a right to
invoke formal rules of procedure and evidence.

12.          Miscellaneous.

12.1        Exclusive Facility Utilization Fee.     Company agrees to pay
Manufacturer an exclusive utilization fee upon receipt of invoice from
Manufacturer  of [***] in lieu of its investments made during the construction
of the manufacturing facility for the exclusive manufacture of the Product
pursuant to that certain Manufacturing Agreement dated April 28, 1999 and the
Commercial Supply Agreement dated 7th October 2004 for the supply of

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Exenatide Cartridges entered into between the parties. If Manufacturer uses said
manufacturing facility for itself or for a third party, then Manufacturer will
provide a credit to Company of [***] per unit of such product. Such credit will
be applied to the first [***] units of product manufactured for the Manufacturer
or a third party.  Further, Manufacturer shall notify the Company prior to using
said manufacturing facility for purposes of manufacturing cartridges for
transfer into Manufacturer’s inventory or for sale to a third party. On or about
each anniversary date of Manufacturer’s commencing use of the manufacturing
facility for producing units for inventory or third party sales, Manufacturer
shall provide Company written notification of the total number of such units of
cartridges transferred into inventory or sold during the preceding year. 
Company shall have the right to conduct an annual audit of all such cartridges
transferred into inventory or sold to third parties.  Promptly following each
such audit, Company shall invoice Manufacturer for all such cartridges
transferred into inventory or sold to a third party during the preceding year. 
Payment shall be due on such invoices not later than thirty (30) days following
receipt thereof.

12.2        No Implied Licenses.  No right or license is granted under this
Agreement by either party to the other, either expressly or by implication,
except those specifically set forth herein.

12.3        Non-Solicitation.

(a)           Manufacturer shall not, during the Term, employ or engage or offer
to employ or engage any person who during the [***] months prior to the
commencement of such employment or engagement was employed by Company.

(b)           Company shall not, during the Term, employ or engage or offer to
employ or engage any person who during the [***] months prior to the
commencement of such employment or engagement was employed by Manufacturer as a
[***] (Grade [***] or higher) [***] employee or a [***] employee

(c)           Notwithstanding the foregoing, nothing in this Agreement shall
prohibit (i) the general advertisement of employment positions by a party in any
trade publication or other publication of general circulation, (ii) the
employment of any current employee of Company by Manufacturer if such person
initiates contact with Manufacturer without any prior solicitation by
Manufacturer or on Manufacturer’s behalf, other than as permitted in clause (i)
hereof, or (iii) the employment of any current employee of Manufacturer by
Company if such person initiates contact with Company without any prior
solicitation by Company or on Company’s behalf, other than as permitted in
clause (i) hereof.

12.4        Independent Contractor Relationship.  Manufacturer’s relationship
with Company will be that of an independent contractor and nothing in this
Agreement should be construed to create a partnership, joint venture, or
employer-employee relationship.  Manufacturer is not an agent of Company and is
not authorized to make any representation, contract, or commitment on behalf of
the Company.  Manufacturer will be solely responsible for all tax returns and
payments required to be filed with or made to any federal, state or local tax
authority with respect to Manufacturer’s performance of services and receipt of
fees under this Agreement.  Manufacturer agrees to accept exclusive liability
for complying with all applicable

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state and federal laws governing self-employed individuals, including
obligations such as payment of taxes, social security, disability and other
contributions based on fees paid to Manufacturer, its agents or employees under
this Agreement.  Manufacturer hereby agrees to indemnify and defend Company
against any and all such taxes or contributions, including penalties and
interest.

12.5        Entire Agreement; Amendment.  This Agreement, together with all
exhibits attached hereto and hereby incorporated herein, constitutes the final,
complete and exclusive agreement of the parties with respect to the subject
matter hereof and supersedes and terminates all prior understandings and
agreements relating to its subject matter, including, without limitation, that
certain Manufacturing Agreement dated April 28, 1999 entered into between the
parties.  This Agreement may not be changed, modified, amended or supplemented
except by a written instrument signed by both parties.

12.6        Severability.  If any provision of this Agreement should be held
invalid or unenforceable, the remaining provisions shall be unaffected and shall
remain in full force and effect, to the extent consistent with the intent of the
parties as evidenced by this Agreement as a whole.

12.7        Assignment; Delegation.  This Agreement shall inure to the benefit
of and be binding upon the successors and assigns of the parties hereto;
provided, however, that neither Company nor Manufacturer shall transfer or
assign this Agreement without the prior written consent of the other party. 
However, Company may assign this Agreement and its rights and obligations
hereunder without such consent to a Collaboration Partner (as defined below) or
in connection with the transfer or sale of all or substantially all of its
assets relating to Pramlintide Acetate or in the event of Company’s merger or
consolidation or change in control of similar transaction.  Manufacturer may not
subcontract or otherwise delegate its obligations under this Agreement without
Company’ prior written consent.

12.8        Governing Law.  This Agreement shall be governed by the laws of the
State of Delaware, excluding its conflict of laws principles.

12.9        Headings.  Section headings are for convenience of reference only
and shall not be considered in the interpretation of this Agreement.

12.10      Days.  Unless otherwise specified herein, references to a number of
days shall reference calendar days.

12.11      Force Majeure.  Neither party to this Agreement shall be deemed to be
in breach of this Agreement or otherwise liable to the other party in any manner
whatsoever for any failure or delay in performing its obligations under this
Agreement due to Force Majeure (as defined herein).  If a party’s performance of
its obligations under this Agreement is affected by Force Majeure, then it shall
give written notice to the other party, specifying the nature and extent of the
Force Majeure, within seven (7) days of becoming aware of the Force Majeure and
will at all times use all reasonable endeavors to mitigate the severity of the
Force Majeure.  If the Force Majeure in question prevails for a continuous
period in excess of ninety (90) days after the date on which the Force Majeure
begins, the party not in default is then entitled to give notice in

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writing to the defaulting party to terminate this Agreement.  The notice to
terminate must specify the termination date, which must not be less than ten
(10) days after the date on which the notice to terminate is given.  Once a
notice to terminate has been validly given, this Agreement will terminate on the
termination date set out in the notice and neither party shall be liable for any
claims, damages or penalties for such failure or delay.  For the purposes
herein, “Force Majeure” means, in relation to either party, acts of God, acts of
war or national emergency, riots, civil commotion, terrorism, fire, explosion,
public utilities failure, or flood.

12.12      Notices.  Any notices required or permitted hereunder shall be given
to the appropriate party at the address specified below or at such other address
as the party shall specify in writing.

If to Company:                                                                
Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, CA 92121

Attn:  Director Supply Agreements & Purchasing

Fax:  (858) 824-7645

With a copy sent to the attention of General Counsel at the same address as
above, Fax:  (858) 552-1936

If to Manufacturer:                                         Wockhardt UK
(Holdings) Ltd.

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

Attn:  Company Secretary

Fax:  0044 1978 661676

All notices shall be deemed made upon receipt by the addressee as evidenced by
the applicable written receipt or, in the case of a facsimile, as evidenced by
the confirmation of transmission, or, in the case of an email, as evidenced by a
reply email.

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

12.14      Non-Waiver.  No failure or delay of one of the parties to insist upon
strict performance of any of its rights or powers under this Agreement shall
operate as a waiver thereof, nor shall any other single or partial exercise of
such right or power preclude any other further exercise of any rights or
remedies provided by law.

12.15      Export.  Manufacturer agrees not to export, directly or indirectly,
any U.S. source technical data acquired from Company or any products utilizing
such data to countries outside the United States, which export may be in
violation of the United States’ export laws or regulations.

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12.16      Product Liability Insurance. Manufacturer will obtain product
liability insurance to the extent Company so advises in writing.  Company will
in turn reimburse Manufacturer for such insurance premiums within thirty (30)
days of the receipt of the invoice for same.  Any product liability claim beyond
such amount will be solely on account of Company.

12.17      Cooperation with Collaboration Partner. Manufacturer acknowledges
that Company may enter into a collaborative arrangement with one or more
companies (each such company, a “Collaboration Partner”) for the sale and
marketing of product(s) containing Pramlintide Acetate, including Product.
Manufacturer agrees to cooperate with any Collaboration Partner in all matters
relating to supply for and regulatory compliance of Product, and to permit
Collaboration Partner access to all facilities, records and information that
Collaboration Partner may reasonably request in connection therewith. Any such
Collaboration Partner shall be deemed a beneficiary of this Agreement, shall
have the right to cure any breach of this Agreement by Company, and with the
consent of Company, which such consent shall not be unreasonably withheld, may
institute legal action to enforce the terms of this Agreement.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the
Effective Date.

Amylin Pharmaceuticals, Inc.

 

WOCKHARDT UK (HOLDINGS) ltd.

 

 

By:

/s/ Daniel M. Bradbury

 

By:

/s/ Sirjiwan Singh

 

 

 

Printed Name:

Daniel M. Bradbury

 

Printed Name:

Sirjiwan Singh

 

 

 

Title:

President and Chief Operating Officer

 

Title:

Managing Director

 

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EXHIBIT A

Pricing

Pramlintide Acetate low-dose 1.5 ml cartridge

[***] per naked cartridge bulk packed in Correx trays

 

 

Pramlintide Acetate demonstration (Placebo) 1.5 ml cartridge

[***] per naked cartridge bulk packed in Correx trays

 

 

Pramlintide Acetate high-dose 2.7 ml cartridge

[***] per naked cartridge bulk packed in Correx trays

 

Above prices are applicable to the following nominal batch yields which, subject
to Section 4.1(b) herein, shall be re-determined in accordance with an agreed
Target Yield:

Product

Batch Quantity (litres)

Batch Yield (cartridges)

 

 

 

1.5ml cartridge

[***]

[***]

 

 

 

2.7ml cartridge

[***]

[***]

 

[***] are inclusive in the prices set forth above.

Any additional services, such as assistance with regulatory submissions,
provision of documentation copies, non-routine quality control testing and
component approval, will be charged at a rate of [***] per man-hour.  These
services and document copies are in addition to those required to be supplied by
the Manufacturer under this Agreement.  All services and copies, and the charges
for them, must be agreed in advance by Company.

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EXHIBIT B

Purchase Specifications for Pramlintide Acetate Injection in Cartridges

(See attached specifications for SYMLIN Injection 1.5mL and 2.7mL Cartridges and

SYMLIN Placebo in Cartridges (PBO-F8))

 

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