Exhibit 10.2


 


***Text
Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. Section 200.80(b)(4)

And 240.24b-2


 


AMENDED AND RESTATED COMMERCIAL
SUPPLY AGREEMENT


 


THIS AMENDED AND RESTATED COMMERCIAL SUPPLY
AGREEMENT (the “Agreement”)
is entered into as of April 1, 2008 (the “Effective
Date”), by and between AMYLIN PHARMACEUTICALS,
INC. (“Company”), having its
principal place of business located at 9360 Towne Centre Drive, San Diego, CA
92121, U.S.A. and Wockhardt UK (Holdings) Ltd., formerly CP
Pharmaceuticals Ltd., (“Manufacturer”),
having its registered office at Ash Road North, Wrexham Industrial Estate,
Wrexham LL13 9UF, United Kingdom and as of the Effective Date hereof shall
amend and replace in its entirety the Commercial Supply Agreement entered into
between Company and Manufacturer as of October 7, 2004 (the “Commercial Supply Agreement”), as
amended.


 


RECITALS


 


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


 


WHEREAS, Company is engaged in research
and development of, and intends to commercialize, pharmaceutical products;


 


WHEREAS, pursuant to the
Development Letter Agreement between the parties dated April 13, 2004 (the
“Letter Agreement”), Manufacturer
has assisted Company in the development of a Manufacturing Process for the
Product (each as defined herein) and has supplied the Product to Company for
use in clinical investigations and registration batches to support regulatory
filings; and


 


WHEREAS, Company wishes to
purchase from Manufacturer, and Manufacturer is willing to supply to Company,
the Product 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; provided, however that the Collaboration
Partner shall not be an Affiliate of Amylin.


 

















 


1.2                               “Applicable Laws” shall mean all United States, European
and any other 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 and 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                               “Approval Date” shall mean the date the FDA grants final
Regulatory Approval of a Drug Approval Application submitted by the Company for
the Product.


 


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


 


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


 


1.6                               “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.


 


1.7                               “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.


 


1.8                               “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.


 


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


 


1.10                        “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.


 


1.11                        “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.


 


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


 

















 


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


 


1.14                        “Exenatide or Exenatide Drug Substance”
shall mean a dry powder preparation containing Exenatide peptide as provided by
Company for further manufacture into Product by Manufacturer.


 


1.15                        “Facilities” shall mean the manufacturing plant and
offices owned by Manufacturer and located at Ash Road North, Wrexham Industrial
Estate, Wrexham LL 13 9UF, 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.


 


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


 


1.17                        “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


 


1.18                        “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.


 


1.19                        “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).


 


1.20                        “Manufacturing Process” shall mean the methods,
techniques, processes and procedures developed under the Development Agreement
or otherwise provided to Manufacturer by the Company or its Collaboration
Partner with respect to Product.


 


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


 


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


 


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


 


1.24                        “Product” shall mean the finished dosage form of
Exenatide, for injection in cartridge presentation as described in Exhibit B
of this Agreement.


 

















 


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


 


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


 


1.27                        “Quality Agreement” shall mean the (Technical) Quality
Agreement among Amylin, Collaboration Partner and Manufacturer dated as of the October 7,
2004, which is incorporated into this Agreement by reference and made a part
hereof.


 


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


 


1.29                        “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.


 


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


 


1.31                        “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.


 


1.32                        “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 frames set
forth on the attached Exhibit C, Company agrees to purchase Product from
Manufacturer in an amount equal to or greater than the minimum quantities set
forth on Exhibit C.  For
clarification, purposes, cartridges purchased as process validation batches,
including those for which purchase orders have been submitted prior to October 7,
2004 by Company to Manufacturer, will count as part of the minimum quantity
required in the Initial Period.  In the
event that during any Purchase Period (as defined in Exhibit C) 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, (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 [***]%, plus or minus [***]%, of the minimum quantity for the Purchase
Period in which the calendar quarter occurs. 
Following the Fifth Period, Manufacturer may bid, in competition with
Company’s other manufactures 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.


 


 


For Product orders not timely shipped by Manufacturer,
Company agrees to add the balance of the delayed Product to the next Purchase
Period with the shipment schedule to be agreed upon by both parties in writing.


 


2.3                               Forecasts.  Beginning within seven days of the Approval
Date and at the commencement of every calendar [***] 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. No later than [***] ([***]) Business days following Company’s
submission of a purchase order 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, unless it is mutually agreed between the parties hereto
in writing.  If purchase orders are
issued less than


 






* Confidential Treatment Request(ed)


 

















 


[***] 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 ten (10) 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                               Price.  Company shall pay to Manufacturer the
applicable Product Price for all Product supplied to Company pursuant to this
Agreement. All shipment and delivery costs directly related to Product shipment
shall be invoiced directly to Company. For any additional services requested by
Company via a purchase order and provided by Manufacturer, such as testing or
packaging, Company shall pay the applicable price set forth on Exhibit A
hereto provided; however, Manufacturer shall provide Company a prior written
estimate of the costs for such services. 
Company shall pay to Manufacturer the actual, out-of-pocket costs for
any materials for which it has agreed herein to be responsible to pay.


 


3.2                               Purchase
Price Adjustment.  Company and Manufacturer
agree to meet no less than twice per year (12 month period) to formally review
continuous improvement activities and other improvements resulting from
experience in operating the Manufacturing Process including potential
adjustments in Materials or Materials pricing. Company and Manufacturer shall
work together to obtain process improvements. 
Net savings or increases in the purchase costs of Materials obtained by
Manufacturer according to Section 4.1(a) shall result in reductions
or increases respectively in the Purchase Price. Net savings in labour costs
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 increased labour costs or changes demanded
by the Company shall result in increases in the Purchase Price. Net savings in
the product cost per unit achieved due to increases in the Target Yield or
manufacturing batch size 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 by a percent which exceeds the lesser of (i) the percentage change
in the [***] or (ii) [***] percent ([***]%) of the original Purchase
Price.  The increase or decrease will be
applicable on 1st May of every calendar year.


 


3.3                               Invoices.  Upon acceptance by Manufacturer of a purchase
order, Manufacturer shall invoice Company for [***] percent ([***]%) of the
estimated aggregate Product Price for the purchase order (the “Reservation Fee”).  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 invoice Company the
Product Price for the quantity of Product manufactured with a credit to Company
in the amount of the Reservation Fee.


 






* Confidential Treatment
Request(ed)


 

















 


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 [***] percent
([***]%) 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
[***] percent ([***]%) 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 [***] at HSBC, 17-19 Regent Street, Wrexham North
Wales, UK. LL11 1RY or to such other account of Manufacturer designated in
writing to Company.  All currency amounts
referenced in this Agreement are to [***].


 


3.7                               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.  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 of this Agreement pursuant to Section 9.3(b) or  Section 9.4, within [***] days Company shall pay to
Manufacturer a sum of [***] ([***]) and payment of such amount shall be a full
and final settlement of all obligations of Company pursuant to this
Agreement.  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
Exenatide provided to Manufacturer pursuant to Section 4.1 hereof and
Materials paid for by Company as directed by and at the expense of Company.


 






* Confidential Treatment
Request(ed)


 

















 


4.                                      Manufacturing.


 


4.1                               Materials.


 


(a)                                  Except
as stated in Section 4.1(b), Manufacturer will obtain any Materials
required for the manufacture of the Product, and shall use commercially
reasonable efforts to obtain the best price for such materials, in reasonable
quantities consistent with Company’s most recent forecast for the Product.
Company shall pay the actual, out-of-pocket cost of the Materials plus the cost
of related quality control testing subject to Sections 3.3 and 3.6.  Manufacturer shall store the Materials at no
cost to the Company.  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 components,
excipients and other 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
components 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 or its Collaboration Partner makes a
good faith determination not to continue with the commercialization of Product,
(ii) Company terminates this Agreement according to Section 9.4, (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 will be placed keeping in view the
future forecasts and delivery lead times. Manufacturer will maintain a safety
stock level of at least [***] ([***]) calendar [***] and ([***]) calendar
[***], but no more than [***] ([***]) calendar [***] of approved
materials.  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 Exenatide sufficient
to enable Manufacturer to manufacture the quantities of the Product ordered by
Company.  Exenatide 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 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 Exenatide occurring as part of the manufacturing process unless
otherwise agreed to by the parties. 
Company and Manufacturer agree to meet no less than twice per year (12
month period) to review losses of Exenatide occurring as part of the
manufacturing process and to negotiate financial responsibility.  For clarity, “satisfactory completion” of a
batch will not include a batch with aberrant results.  The Target Yield shall be defined as [***]
percent ([***]%) of the Batch 


 






* Confidential Treatment
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Yield as set forth on Exhibit A.  All shipments of Exenatide will be
accompanied by a Certificate of Analysis indicating the peptide content of such
Exenatide and such other information as Amylin may specify and is to arrive
approximately [***] days in advance of planned Product manufacture to allow for
testing.  Within [***] ([***]) business
days of receipt of any Exenatide hereunder, Manufacturer will verify the
quantity and identity of such shipment of Exenatide according to test methods
approved and provided by Company and shall inspect the Exenatide in accordance
with Manufacturer’s incoming material inspection procedures.  If Manufacturer detects any discrepancies in
the Exenatide in quantity or in the identity based on the identity testing
performed, Manufacturer shall inform Company immediately upon, but no later
than [***] ([***]) business days after, having detected such
discrepancies.  Manufacturer shall also
inform Company of any obvious damage to the Exenatide or container received
within [***] ([***]) business days of Manufacturer’s receipt thereof.  Any rejected Exenatide shall be returned at
Company’s expense and direction.  Company
shall make all final determinations if material is 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 each
of Company and Collaboration Partner (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 agreed in writing between the Parties prior to shipment of Exenatide
Injection 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 Exenatide
Injection, (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 Exenatide Injection.


 


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.


 






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(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 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 and Collaboration Partner such documentation, data and
other information relating to the Facilities,
Products, or Manufacturer’s manufacturing processes and procedures for Product
as Company or Collaboration Partner may request for submission to Regulatory
Authorities.


 


(b)                                  Company
and Collaboration Partner 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 the Collaboration Partner 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
any OUS Country. Manufacturer shall assist Company and Collaboration Partner in
the preparation of all documents necessary to effectuate Company’s and
Collaboration Partners 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 and Collaboration Partner in obtaining such
Regulatory Approvals.  For the avoidance
of doubt, Company and Collaboration Partner have sole responsibility for the
content of all Drug Approval Applications.


 


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 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 and Collaboration Partner 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 and its
Collaboration Partner access to the Facility, documentation, and personnel to
audit and for observation of the production process and quality control testing
of the Exenatide Injection, disposal of waste and adherence to cGMP
requirements and this Agreement. During such inspections, employees of the
Company and its Collaboration Partner (number of persons should be restricted
to not more than [***] ([***]))
shall have the right to audit any aspect of the Manufacturers manufacture of
Exenatide Injection, 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 Exenatide
Injection.


 


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 Collaboration Partner, 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 each of Company and
Collaboration Partner to be present during the 


 






* Confidential Treatment
Request(ed)


 

















 


inspection.  Manufacturer shall allow Company and
Collaboration Partner to participate in the formulation of any response to
regulatory inspections or any other issues raised by any Regulatory Authority
related to the 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 and
Collaboration Partner 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 and Collaboration Partner in
investigating any Batch that fails to meet the Product 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 and Collaboration Partner 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 and, if directed by Company, to Collaboration Partner.  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 or Collaboration Partner shall be responsible for all reporting
of such information to Regulatory Authorities.


 


4.12                        Labeling;
Trademark.  Manufacturer shall affix labeling
to the Product as and if directed by Company. 
Nothing in this Agreement gives Manufacturer the right to use any
trademark or trade name of Company or Collaboration Partner except as specified
in writing by Company or Collaboration Partner. 
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 2.3. 
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.


 


5.2                               Title.  Title to all Exenatide shall at all times
remain in Company.  Title to all
Materials other than Exenatide, work in progress to produce Product, and all
completed Product (except Exenatide contained therein) shall remain with
Manufacturer until delivery of such Product to the carrier designated by
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 necessary or 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 


 






* Confidential Treatment
Request(ed)


 

















 


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 reimburse Company for Company’s cost for (i) any
Exenatide used in such rejected Batch, at the rates set forth in and subject to
the maximum liability stated in Section 10.3; and (ii) amounts paid
to Manufacturer by Company pursuant to Section 3.3.  Compliance with the provisions of this Section 5.3(c) and
payment of the costs in Section 5.3(d) and (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 and/or determination.  Whether or not Manufacturer 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 the other warranties in Section 8,
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 reimburse Company for (i) Company’s cost for any Exenatide used in
such rejected Batch, at the rates set forth in and subject to the maximum
liability stated in Section 10.3 and (ii) amounts paid by Company
pursuant to Section 3.3. Compliance with 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 or its Collaboration Partner to be due in part to a
failure of the Manufacturer to 


 






* Confidential Treatment Request(ed)


 

















 


comply with its warranties stated in Section 8.3
of this Agreement then Company or, in the case of a Recall Action in an OUS
County, Collaboration Partner,  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 and its Collaboration Partner in
investigating any such Recall Action, if Company or its Collaboration Partner
so requests, and all regulatory contacts that are made and all activities
concerning such Recall Action will be initiated and coordinated by Company or,
in the case of a Recall Action in an OUS Country, Collaboration Partner with
Manufacturer’s involvement and assistance, as reasonably requested by Company
or its Collaboration Partner.


 


(b)                                 If
any Recall Action occurs which is considered by the Company or its
Collaboration Partner 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 or its Collaboration Partner 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 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.


 


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 (or, with
respect to Company, to Collaboration Partner), 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, nor shall Manufacturer use Collaboration Partner’s
name, in connection with any publication or promotion without the other party’s
written consent, or, as applicable to Manufacturer, Collaboration Partner’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.


 

















 


6.5                               Collaboration
Partner.  For purposes of this Agreement,
Confidential Information shall include all information confidential and/or
proprietary to Collaboration Partner that is provided to Manufacturer under
this Agreement and Manufacturer agrees to comply with the confidentiality
obligations under this Section 6 with respect to all of such information
of Collaboration Partner supplied hereunder.


 


7.                                      Intellectual
Property Rights.


 


7.1                               Company
Inventions.  All right, title and
interest in and to any intellectual property rights in Exenatide 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 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.  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, make, have made, import, offer to sell, have sold and sell
Product or any other product containing Exenatide; 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 compensation to be paid to the Manufacturer.


 


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;


 






* Confidential Treatment
Request(ed)


 

















 


(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 the Product.


 


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.


 


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 October 7, 2004 and, unless terminated earlier as provided herein,
shall continue until the expiration of the Fifth Period (as defined in Exhibit C),
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 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 Approval 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 Exenatide 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, 4.8, 4.9, 4.10, 4.11, 6, 7,
8.3, 8.5, 8.6, 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 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
Indemnitee 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 and hold
harmless Company and Collaboration Partner and their respective 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 Exenatide 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 Indemnitee shall have the right to
select and to obtain representation by separate legal counsel at Company’s own
expense.


 


10.3                        Loss of
Exenatide.  If any Exenatide 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 ($[***]) per gram of
Exenatide limited to a maximum of [***] US dollars ($[***]) for each individual
incidence of loss prior to validation of the increase in batch size (the “Batch
Size Increase”) and at a rate of [***] US dollars ($[***]) per gram of
Exenatide limited to a maximum of [***] US dollars ($[***]) for each individual
incidence of loss after the Batch Size Increase.  For the avoidance of doubt Manufacturer shall
not be liable for loss of Exenatide if peptide content has deteriorated and
Manufacturer has complied fully with the storage requirements for Exenatide 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 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.


 






* Confidential Treatment
Request(ed)


 
















 


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 has 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. 
Collaboration Partner and its counsel shall have the right to be present
at all arbitration hearings and review all documents related to or produced as
part of the arbitration.


 


(e)                                  The
arbitration will be confidential and the arbitrators will issue appropriate
protective orders to safeguard each party’s Confidential Information and, to
the extent necessary, Collaboration Partner’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.


 


(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                        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.


 


12.2                        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 or Collaboration Partner.


 






* Confidential Treatment
Request(ed)


 

















 


(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) [***] 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.


 


12.3                        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 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.


 


12.4                        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 all prior
understandings and agreements relating to its subject matter.  This Agreement may not be changed, modified,
amended or supplemented except by a written instrument signed by both parties.


 


12.5                        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.


 


12.6                        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
Collaboration Partner or in connection with the transfer or sale of all or
substantially all of its assets relating to Exenatide 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.


 






* Confidential Treatment
Request(ed)


 

















 


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


 


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


 


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


 


12.10                 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 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.


 


12.11                 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

  
	
   

  	
   

  	
  Fax: (858) 552-2212

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  With a copy sent to the attention of General Counsel
  at the same address and fax as above

  



 

















 


	
  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.


 


12.12                 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.


 


12.13                 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.


 


12.14                 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.


 


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


 


12.16                 Cooperation with
Collaboration Partner. Manufacturer acknowledges that Amylin’s
Collaboration Partner will make all sales of Product outside the U.S. and will
serve as the regulatory lead in all jurisdictions outside the United States.
Manufacturer 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.  Lilly 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 institute legal action to enforce the terms
of this Agreement.


 

















 


IN WITNESS WHEREOF, the parties
hereto have executed this AMENDED AND RESTATED
COMMERCIAL SUPPLY AGREEMENT as of the Effective Date.


 


	
  AMYLIN PHARMACEUTICALS, INC.

  	
  WOCKHARDT UK (HOLDINGS) LTD.

  
	
   

  	
   

  
	
  By:

  	
    /s/ Paul
  Marshall

  	
   

  	
  By:

  	
    /s/
  Sirjiwan Singh

  
	
   

  	
   

  	
   

  	
   

  
	
  Printed Name:

  	
    Paul
  Marshall

  	
   

  	
  Printed Name:

  	
    /s/
  Sirjiwan Singh

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
    Vice
  President, Operations

  	
   

  	
  Title:

  	
    Managing
  Director

  
									



 


[SIGNATURE PAGE TO
AMENDED AND RESTATED SUPPLY AGREEMENT]


 

















 


EXHIBIT A


 


Pricing


 


	
  Exenatide low-dose 1.2
  ml cartridge

  	
   

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

  
	
   

  	
   

  	
   

  
	
  Exenatide (Demo) 1.2 ml
  cartridge

  	
   

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

  
	
   

  	
   

  	
   

  
	
  Exenatide high-dose 2.4
  ml cartridge

  	
   

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

  
	
   

  	
   

  	
   

  
	
  Exenatide 3 ml
  cartridge

  	
   

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

  



 


	
  Cartridge Size

  	
   

  	
  Batch Yield

  
	
  1.2mL

  	
   

  	
  [***]

  
	
  2.4mL

  	
   

  	
  [***]

  



 


Materials, in-process
analytical and microbiological testing, finished product sterility/endotoxin
testing and packaging 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 Amylin.


 






* Confidential Treatment
Request(ed)


 

















 


EXHIBIT B


 


Title:                  Specification for Exenatide
Injection in Cartridges


 


Corporate
Specification for Exenatide Injection in Cartridges (AC2993-F8)


 


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


 


	
  ATTRIBUTE

  	
   

  	
  ALERT LIMIT(1)

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD(2)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](3) or [***]

  
	
  [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  NMT [***] counts/container

  NLT [***]μm

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] ± [***] Da

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

  	
   

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

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NLT [***]% [***]

  	
   

  	
  NLT [***]%

  	
   

  	
   

  
	
  Total [***]

  	
   

  	
  NMT[***]% [***]

  	
   

  	
  NMT [***]%

  	
   

  	
   

  
	
  Individual [***]

  [***]AC2993
 [***]AC2993

  	
   

  	
  [***]

  NMT[***]%
 NMT [***]%

  	
   

  	
  NMT [***]%

  NMT [***]%

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  LT [***] EU/mL

  	
   

  	
  [***](3) or [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](3) or [***]

  
	
  [***]

  	
   

  	
  NMT [***]

  	
   

  	
  [***]

  	
   

  	
  [***](3) or [***]

  
	
  [***]

  	
   

  	
  NMT [***]

  	
   

  	
  [***]

  	
   

  	
  [***](3) or [***]

  
	
  [***]

  	
   

  	
  NLT [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***]

  



 


LT = less than

NLT = not less than

NMT = not more than


 






(1) [***] represent [***], [***] or [***].  [***] or [***].


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


(3) [***] are, for [***],[***] or [***]; for [***],[***] or [***]; for
[***],[***] or [***]; and for [***], [***] or [***].


 


* Confidential Treatment Request(ed)


 

















 


EXHIBIT B, CONT.


 


Title:                  Specification for Exenatide
Injection in Cartridges


 


U.S.
Regulatory Specification Exenatide Injection in Cartridges (AC2993-F8)




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


 


	
  ATTRIBUTE

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD(1)

  
	
  [***]

  	
   

  	
  [***],
  [***], and [***]

  	
   

  	
  [***](2)
  or [***]

  
	
  [***]

  	
   

  	
  [***]
  to [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]
  to [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NLT
  [***]%

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NMT
  [***]%

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NMT
  [***]%

  	
   

  	
   

  
	
  [***]

  	
   

  	
  NMT
  [***]%

  	
   

  	
   

  
	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](2)
  or [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](2)
  or [***]

  



 


LT=
less than

NLT = not less than

NMT = not more than


 






(1)
[***] are used for [***], except [***] are used for [***], and may be used in
[***].


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


 


*
Confidentiality treatment request(ed).


 

















 


EXHIBIT B, CONT.


 


Title:                  Specification for Placebo
Exenatide Injection in Cartridges


 


Corporate
Specification for PBO-F12


 


Description:                               [***] containing [***]% (w/v) [***], [***]% (w/v) [***] in [***] mM
[***], in 1.2, 2.4, or 3.0 mL cartridges


 


	
  ATTRIBUTE

  	
   

  	
  ALERT LIMIT

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***](a)

  
	
  [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] counts/container [***]μm

  [***] counts/container [***]μm

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 






(a) [***] used at [***];
[***] may be used during [***].


 


* Confidential treatment
request(ed).


 

















 


EXHIBIT B, CONT.


 


Title:                  Specification for Placebo
Exenatide Injection in Cartridges


 


Regulatory
Specification for PBO-F12


 


Description:                               [***] containing [***]% (w/v) [***], [***]%
(w/v) [***] in [***] mM [***], in 1.2, 2.4, or 3.0 mL cartridges


 


	
  ATTRIBUTE

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]
  or [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]
  or [***](a)

  
	
  [***]

  	
   

  	
  [***]
  to [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

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

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]
  counts/container [***]μm

  [***] counts/container [***]μm

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]
  to [***]

  	
   

  	
  [***](a)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 










(a) [***] used at [***];
[***] may be used during [***].




* Confidential treatment
request(ed).


 





















 


EXHIBIT C


 


MINIMUM ORDERS


 




	
  Purchase

  Period

  	
   

  	
  Date Range

  	
   

  	
  Minimum

  Quantity

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Initial Period

  	
   

  	
  4-28-05 to 4-27-06

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2nd Period

  	
   

  	
  4-28-06 to 4-27-07

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3rd Period

  	
   

  	
  4-28-07 to 4-27-08

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4th Period

  	
   

  	
  4-28-08 to 4-27-09

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5th Period

  	
   

  	
  4-28-09 to 4-27-10

  	
   

  	
  [***]

  






 






* Confidential treatment
request(ed).