Document:

Exhibit
10.44

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

And 240.24b-2

 

COMMERCIAL
SUPPLY AGREEMENT

 

THIS SUPPLY AGREEMENT (the “Agreement”)
is entered into as of October 7, 2004 (the “Effective
Date”), by and between AMYLIN PHARMACEUTICALS,
INC. (“Company”), having its
principal place of business located at 9360 Towne Centre Drive, Suite 110,
San Diego, CA 92121, U.S.A. and CP Pharmaceuticals Ltd. (“Manufacturer”),
having its registered office at Ash Road North, Wrexham Industrial Estate,
Wrexham LL13 9UF, United Kingdom.

 

RECITALS

 

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

 

WHEREAS, Company is engaged in research 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 and
European jurisdiction’s federal, state, local and other laws, statutes, rules,
regulations, ordinances, (including any amendments thereto), applicable to the
manufacture and shipment of Product,

 

 

including,
without limitation, the applicable regulations and guidance of the FDA, all
applicable EU cGMPs. Extensions to the aforementioned defined territories shall
be the subject of side letters to this Agreement which may be jointly agreed in
good faith from time to time between the Parties.

 

1.3          “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 LL13 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        “Materials” shall mean raw materials, components,
excipients and other ingredients and packaging materials used in the
manufacture and packaging of Product.

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

1.29        “Regulatory Authority” shall mean the FDA in the United States
or the MHRA, EMEA or any other 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.

 

1.30        “Specifications” shall mean the regulatory,
manufacturing, quality control and quality assurance procedures, processes,
practices, standards, instructions and any other attributes that the parties
agree upon, or that are otherwise required, in connection with the manufacture of
Product, as set forth on Exhibit B, as
amended from time to time by written agreement of the parties pursuant to Section 2.6.

 

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

 

2.             Purchase and Supply.

 

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

 

2.2          Minimum Orders. 
For the time frame beginning on the Effective Date and ending on the
first day of the calendar month after the date of the one year anniversary of
the Approval Date (the “Initial Period”),
Company agrees to purchase Product from Manufacturer in an amount equal to or
greater than [***] ([***]) cartridges. 
For clarification purposes, cartridges purchased as process validation
batches,  including
those for which purchase orders have been submitted prior to the Effective Date
by Company to Manufacturer, will count as part of the minimum quantity required
in the Initial Period.  For the time
frame beginning on the date the Initial Period ends and ending on the one year
anniversary thereof (the “Second Period”),
Company agrees to purchase Product from Manufacturer in an amount equal to or
greater than [***] ([***]) cartridges. 
For the time frame beginning on the date the Second Period ends and
ending on the one year anniversary thereof (the “Third
Period”), Company agrees to purchase Product from Manufacturer
in an amount equal to or greater than [***] ([***]) cartridges. For the time
frame beginning on the date the Third Period ends and ending on the one year
anniversary thereof (the “Fourth Period”),
Company agrees to purchase Product from Manufacturer in an amount equal to or
greater than [***] ([***]) cartridges. For the time frame beginning on the date
the Fourth Period ends and ending on the one year anniversary thereof (the 

 

* Confidential Treatment Request(ed)

 

 

“Fifth Period” and together with the Initial Period, the Second Period,
the Third Period, and the Fourth Period, the “Purchase Periods”), Company agrees to purchase Product from
Manufacturer in an amount equal to or greater than [***] ([***])
cartridges.  In the event that during any
Purchase Period the Company’s actual purchases of the Product from Manufacturer
are less than the minimum amount specified above for said Purchase Period,
Company will pay to Manufacturer the difference between the amount invoiced to
Company for its actual purchases during the Purchase Period and the amount that
would have been invoiced had Company purchased the minimum amount agreed to for
such Purchase Period; provided, however, (i) Company shall not be obligated to
make any such payments if the Agreement has been terminated, and (ii) the
Company shall only be obligated to pay for Product supplied to the Company
pursuant to this Agreement.  In any given
calendar quarter, Company shall order [***]% of the
minimum quantity, plus or minus [***]%, for the Purchase Period in which the
calendar quarter occurs.  Following the
Fifth Period, Manufacturer may bid, in competition with Company’s other
manufacturers of the Product, to provide a greater percentage of Company’s
requirements of the Product.  For
purposes of this Section 2.2, a “purchase” shall mean the submission by
Company of a firm purchase order.

 

2.3          Forecasts. 
Beginning within seven days of the Approval Date and at the commencement
of every calendar quarter 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 five (5) 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,
except to the extent that any term, provision or condition set forth in a
purchase order expressly states that it supersedes any term, provision or
condition of this Agreement, unless it
is mutually agreed 

 

* Confidential Treatment Request(ed)

 

 

between the parties
hereto.  If purchase orders are issued less than [***]
Business days in advance of the desired shipment date, Manufacturer shall make
commercially reasonable efforts to meet Company’s requirements, however
Manufacturer’s failure to meet such requirements shall not be deemed to be a
breach of this Agreement.  In the event a
purchase order is issued less than [***] ([***]) Business days in advance of
the desired shipment date, Manufacturer shall advise Company within (5) five
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          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 plus [***] percent ([***]%) of the cost, including
quality control testing costs, of the raw materials, components and sundry
production items to be used in the manufacture of Product which is the subject
of the purchase order.  The balance of each
purchase order shall be invoiced to Company upon the submission Batch Records
duly approved by Manufacturer to Company for the batches of Product
manufactured for such purchase order.

 

3.3          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.

 

3.4          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.

 

3.5          Method of Payment; Currency. 
All payments due hereunder to Manufacturer shall be paid to Manufacturer
in [***] not later than [***] ([***]) days following 

 

* Confidential Treatment Request(ed)

 

 

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 Lloyds Bank, 53 King Street, Manchester
M60 2ES, UK, Sort Code 30-95-42 or to such other account of Manufacturer
designated in writing to Company.  All
currency amounts referenced in this Agreement are to [***].

 

3.6          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 7.6.
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 termination of this Agreement pursuant to Section 9.3(b) or Section 9.4, within [***] days
Company shall pay to Manufacturer a sum of [***] British pounds sterling
(£UK[***]) 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.

 

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 3.2 and 3.5. 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 or is Collaboration Partner; 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 

 

* Confidential Treatment Request(ed)

 

 

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 the
process validation batches) of each of the presentations of Product,
Manufacturer shall make commercially reasonable efforts to maximize yields but
shall not be held liable for losses of Exenatide occurring as part of the
manufacturing process. After satisfactory completion of the first [***]
commercial full scale batches of each Product the Parties shall meet to agree a
target yield for future production (Target Yield). The Target Yield shall be
defined as [***] percent ([***]%) of the average yield
of the [***] batches of each presentations of Product. For clarity, “satisfactory
completion” of a batch will not include a batch with aberrant results.  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 and procedures 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 

 

* Confidential Treatment Request(ed)

 

 

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.

 

(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 (no. 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.

 

* Confidential Treatment Request(ed)

 

 

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 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 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 carrier designated by the
Company.  Notwithstanding the foregoing,
and regardless of whether delivery of Product to Company has occurred under Section 5.1,
Manufacturer shall bear all risk of loss with respect to, and shall insure, all
Product until transfer by Manufacturer to a carrier
for shipment as directed by Company in the applicable purchase order.

 

5.3          Acceptance and Rejection.

 

(a)           Concurrent with the delivery of any
Batch, Manufacturer shall provide Company with all documentation required to be
provided to Company under the Quality Agreement, including, without limitation,
a Certificate of Analysis 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 

 

* Confidential Treatment Request(ed)

 

 

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 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 3.2.  Compliance with the provisions of this Section 5.3(c)
and payment of the costs in Sections 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 rules shall bear all costs of the third
party testing.  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,
at its cost, within [***] ([***]) days. 
If the third party tester 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 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 3.2. Compliance with the
provisions of this Section 5.3(d) and payment of the costs in Section 5.3(e)
shall be Manufacturer’s sole only liability to Company where Company rejects a
Batch of and either Manufacturer agrees, or a third party determines under Section 5.3(d),
that such rejection is justified, subject only to Section 10.4. Manufacturer shall
have no further liability to the Company in respect of such Batch except to
what is stated herein.

 

* Confidential Treatment Request(ed)

 

 

(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 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 Country, 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.

 

* Confidential Treatment Request(ed)

 

 

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”). 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.

 

7.3          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.

 

7.4          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).

 

7.5          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.

 

7.6          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 sublicense 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.

 

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.

 

* Confidential Treatment Request(ed)

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

8.4          The Company represents,
warrants and agrees that:

 

a)             The manufacture of Product as
contemplated herein, will not, to the Company’s knowledge, infringe any
existing patents or any other proprietary rights of third parties, and as of
the date hereof Company has not received any notice of any claimed infringement
(including without limitation patent infringement) in connection with 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 8.6 shall not be construed
to limit either party’s indemnification obligations under Section 10 or to
limit remedies available for breach of confidentiality and non-use obligations
or for infringement or misappropriation of intellectual property rights.

 

9.             Term and Termination.

 

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

 

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

 

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

 

(b)           effective by giving 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, 4.7, 4.9, 6, 7, 8.3, 8.5, 8.6, 9.5, 9.6, 9.7, 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, Manufacturer’s liabilities shall be determined at
a rate of [***] US dollars ($[***]) per gramme of Exenatide and limited to a
maximum of [***] US dollars ($[***]) for each individual incidence of
loss.  For the avoidance of doubt
Manufacturer shall not be liable for loss of 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 

 

* Confidential Treatment Request(ed)

 

 

to pursuing other available remedies.  If, within sixty (60) days after such written
request, the parties have not succeeded in negotiating a resolution of the
dispute, such dispute shall be resolved by final and binding arbitration in
accordance with Section 11.2.

 

11.2        Arbitration.

 

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

 

(b)           The arbitration shall be conducted by
three (3) arbitrators who shall be knowledgeable in the subject matter which is
at issue in the dispute 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 

 

* Confidential Treatment Request(ed)

 

 

commencement of such employment or engagement was employed by
Company or Collaboration Partner.

 

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

 

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

 

12.3        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

 

* Confidential Treatment Request(ed)

 

 

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.

 

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, Suite 110

  
	
   

  	
   

  	
  San Diego, CA
  92121

  
	
   

  	
   

  	
  Attn: Senior Director,
  Manufacturing

  
	
   

  	
   

  	
  Fax: (858)
  558-0257

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  With a copy sent
  to the attention of General Counsel at the

  
	
   

  	
   

  	
  same address as
  above, Fax: (858) 552-1936

  

 

 

	
  If to Manufacturer:

  	
   

  	
  CP
  Pharmaceuticals, 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 SUPPLY AGREEMENT
on the Effective Date.

 

	
  AMYLIN
  PHARMACEUTICALS, INC.

  	
  CP
  PHARMACEUTICALS, LTD.

  
	
   

  	
   

  
	
  By: 

  	
  /s/
  Gregg Stetsko

  	
   

  	
  By: 

  	
  /s/
  Lalit Kumar

  	
   

  
	
   

  	
   

  
	
  Printed Name: 

  	
  Gregg Stetsko

  	
   

  	
  Printed Name: 

  	
  Lalit Kumar

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Vice President,
  Operations

  	
   

  	
  Title: 

  	
  Director

  	
   

  
														

 

 

[SIGNATURE PAGE TO
SUPPLY AGREEMENT]

 

 

EXHIBIT A

 

Pricing

 

	
  Exenatide
  low-dose1.2 ml cartridge

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

  
	
   

  	
   

  
	
  Exenatide
  demonstration (Placebo) 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

  

 

Analytical and
microbiological 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.

 

All prices shall
increase on [***] of each [***] following the Approval Date by the lesser of
(a) the most recently reported [***] or (b) [***] percent ([***]%).

 

* Confidential Treatment Request(ed)

 

 

Exhibit “B”

 

 Purchase Specification for
Exenatide Injection in Cartridges

 

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)

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***] or [***]

  
	
  [***]

  	
   

  	
  [***] to [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] ±
  [***] Da

  	
   

  	
  [***]

  
	
  [***]

  [***]

  [***]

  	
   

  	
  [***]

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

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

  	
   

  	
  [***]

  
	
  [***]

  Total [***]

  Individual [***]

  [***]AC2993 

  [***]AC2993

  	
   

  	
  NLT [***]%

  NMT [***]%

  

  NMT [***]%

  NMT [***]%

  	
   

  	
  [***]

  
	
  [***]

  	
   

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

  	
   

  	
  [***] or [***]

  
	
  [***]

  	
   

  	
  LT [***] EU/mL

  	
   

  	
  [***] or [***]

  
	
  [***]

  	
   

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

  	
   

  	
  [***] or [***]

  
	
  [***]

  [***]

  	
   

  	
  NMT [***]

  NMT [***]

  	
   

  	
  [***] or [***]

  
	
  [***]

  	
   

  	
  NLT [***]

  	
   

  	
  [***], 

  [***] or 

  [***]

  

 

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

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

 

* Confidential Treatment Request(ed)***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

And 240.24b-2

 

Exhibit 10.45

 

COMMERCIAL SUPPLY
AGREEMENT

 

This
Commercial Supply Agreement (this “Agreement”) is entered into and effective
this 2nd day  of March, 2005 (the
“Effective Date”) by and between Baxter Pharmaceutical Solutions LLC (“BAXTER”), a Delaware limited liability
company having a place of business at 927 South Curry Pike, Bloomington,
Indiana 47403, and Amylin Pharmaceuticals (“AMYLIN”),
a Delaware corporation having a principal place of business at 9360 Towne
Centre Drive, Suite 110, San Diego, California 92121.

 

 

RECITALS

 

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

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

3.                                       AMYLIN and
BAXTER are parties to a Drug Product Development and Supply Agreement dated
November 7, 2003, related to the Product (as defined below); and

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

 

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

 

Article
1.  DEFINITIONS

 

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

 

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

 

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

 

1

 

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

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

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

1.6                                 “BAXTER
Approval” shall mean authorizations by the appropriate
Regulatory Authority necessary for BAXTER to Produce Product for commercial
sale in a jurisdiction.

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

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

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

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

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

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

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

1.10                           “Contaminant” shall mean any substance contained in Product that
(a) causes Product to fail to meet Product Requirements, (b) causes Product to
be adulterated within the meaning of the FD&C Act, or (c) is present in
Product at a level that exceeds the level allowed under cGMP.

1.11                           
“Current Good Manufacturing Practices” or “cGMP”
shall mean (a) the good manufacturing practices required by the FDA and set
forth in the FD&C Act or FDA Regulations (including without limitation 21
CFR 210 and 211), the principles and 

 

2

guidelines
specified in Chapter II of European Commission Directive 91/356/Eed, including
the rules governing medicinal products (in the European Union Volume 4),
policies or guidelines, in effect at any time during the term of this
Agreement, for the Production and testing of pharmaceutical materials as
applied solely to Products, and (b) the corresponding requirements of each
applicable Regulatory Authority.

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

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

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

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

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

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

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

1.19                           “OMJ
Vials” shall mean the vials of Pramlintide Drug
Substance in finished dosage form in a vial container closure system produced
by OMJ Pharmaceuticals, Inc. and delivered to BAXTER for packaging.

1.20                           “Pramlintide
Drug Substance” shall mean a dry powder
preparation containing pramlintide peptide as provided by AMYLIN for further
manufacture or Production into Product by BAXTER.

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

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

1.23                           “Product” shall mean
placebo or Pramlintide Drug Substance in finished dosage form filled into a
vial container closure system as specified in Exhibit A and packaged as
specified in the applicable Project Plan and either Produced after the first
Regulatory Approval therefore or Produced as part of the Process Validation
Batches, provided regulatory approval is obtained which allow commercial sale
of such 

 

3

Process
Validation Batches.  In addition, the OMJ
Vials shall be deemed Product for purposes of this Agreement, except Article 4
and Exhibit F.

1.24                           “Process
Validation Batches” shall mean vials produced
for the purposes of validating the processing parameters for Production of
Product produced pursuant to the Drug Product Development Agreement dated
November 7, 2003.  The parties agree that
the Product Produced in the Process Validation Batches may be sold commercially
provided regulatory approval is obtained which allows commercial sale of such
Process Validation Batches and that all the terms of this Agreement, except
Article 7, shall apply to the Product Produced in the Process Validation
Batches.

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

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

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

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

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

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

1.31                           “Regulatory
Authority” shall mean the FDA in the United States, or the
applicable regulatory agency or entity having the responsibility, jurisdiction,
and authority to approve the manufacture, use, importation, packaging,
labeling, marketing, and sale 

 

4

 

of
Product in any jurisdiction other than the United States, as specified in
Exhibit E, as may be amended from time to time by mutual agreement of the
parties.

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

1.33                           “Release”
shall mean the delivery of the Released
Executed Batch Record to AMYLIN by BAXTER.

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

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

1.36                           “Unit” shall mean an
individually packaged dose of Product or placebo, as specified in Exhibit B for
vials.

 

Article
2,  Reserved

Article 3, PURCHASE AND SUPPLY OF PRODUCT

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

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

 

5

 

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

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

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

 

3.6                               Importer
of Record.  In the event
any material or equipment to be supplied by AMYLIN, including without
limitation AMYLIN Supplied Components and Pramlintide Drug Substance, is
imported into the United States for delivery to BAXTER (“Imported Goods”), such
Imported Goods shall be imported DDP Bloomington, IN (Incoterms 2000).  AMYLIN shall be the “Importer of Record” of
such Imported Goods.  As the Importer of
Record, AMYLIN shall be responsible for all aspects of the Imported Goods 

 

6

 

including, without limitation (a) customs and other regulatory
clearance of Imported Goods, (b) payment of all tariffs, duties, customs, fees,
expenses and charges payable in connection with the importation and delivery of
the Imported Goods, and (c) keeping all records, documents, correspondence and
tracking information required by applicable laws, rules and regulations arising
out of or in connection with the importation or delivery of the Imported Goods.

 

3.7          Storage.

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

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

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

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

* Confidential Treatment Request(ed)

7

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

3.8                                           Purchase of Materials.  BAXTER shall
purchase, at BAXTER’s expense, all packaging materials listed in the Project Plan, primary container Components and secondary
packaging materials required to Produce the Product; provided, however, AMYLIN
shall approve in writing and in advance all specifications for AMYLIN-specific
materials (i.e. non-stock items).  BAXTER
shall control packaging materials listed in the Project
Plan and shall assist AMYLIN with evaluation and purchase of modified materials
in the event that AMYLIN requests a change in Presentation.  BAXTER shall not initiate any changes to materials
without written approval from AMYLIN.

Article 4,  FORECASTS, ORDERS,
and CAPACITY

4.1                                 Forecasts
and Order Limits.

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

4.1.2                         Except as set
forth in Section 4.1.3, during each calendar quarter, BAXTER shall supply
AMYLIN with the quantity of Product ordered by AMYLIN, unless the quantity
ordered in any calendar [***] exceeds [***] percent ([***]%) of the quantity
purchased in the previous calendar [***], in which event BAXTER shall use good
faith efforts to supply quantities in excess of such amount.  Notwithstanding the foregoing, in any given
calendar quarter in no event will BAXTER be obligated to Produce, more than
[***] ([***]) units more than it Produced in the previous calendar
quarter.  For each Rolling Forecast
submitted by AMYLIN, in no event shall AMYLIN purchase less than (a) [***]
percent ([***]%) of the quantity forecasted for the [***] of such Rolling
Forecast, (b) [***] percent ([***]%) of the quantity of Product forecasted by
Presentation for the [***] of such Rolling Forecast, and (c) [***] percent
([***]%) of the quantity of Product forecasted by 

* Confidential Treatment Request(ed)

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Presentation for the [***] quarter of such Rolling Forecast
(collectively, the “Minimum Quantity”). 
In each succeeding calendar [***], in the event AMYLIN purchases in any
given [***] less than the corresponding portion of the Minimum Quantity for
said [***] within [***] ([***]) days after the end of such [***] AMYLIN shall
pay to BAXTER the difference between the Purchase Price of Product actually
purchased and the Purchase Price of the corresponding portion of the Minimum
Quantity in said quarter, provided, however, AMYLIN shall not be required to
make any such payments to the extent AMYLIN has submitted Purchase Orders for
the  Minimum Quantity and BAXTER
confirmed such Purchase Orders to be Firm Purchase Orders, but BAXTER was
unable to deliver such quantities of Product due to the negligence of
BAXTER.  In any given Rolling Forecast, (a) the quantity
forecasted for the [***] of such Rolling Forecast shall not be less than (a)
[***] percent
([***]%) of the
[***] forecast
in the immediately preceding Rolling Forecast and (b) [***] percent ([***]%) of the [***] forecast in the immediately preceding
Rolling Forecast.

4.1.3                         Pursuant to Section 4.2, beginning on the Effective Date of
this Agreement and continuing through the end of the first calendar year (the
year of the Effective Date of this Agreement) BAXTER shall only be obligated to
supply that quantity of Product ordered by AMYLIN, which is submitted to BAXTER
via a Firm Purchase Order and BAXTER accepts via a confirmation.   For the avoidance of doubt, BAXTER’s
obligations under Section 4.1.2 shall not apply during 2005.

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

4.3                               Annual Obligation. 
AMYLIN shall be obligated to purchase from BAXTER a minimum number of
Units of such Product in each calendar year following BAXTER 

* Confidential Treatment Request(ed)

9

Approval during the Term of this Agreement as specified in Exhibit F
(the “Annual Obligation”), which Annual Obligation shall be pro rated for any
partial calendar year.  Within [***]
([***]) days after the end of each calendar year, AMLYIN shall pay to BAXTER the
difference between the Purchase Price of the Product actually purchased
pursuant to Sections 4.1 and 4.2 by AMYLIN and the Purchase Price of the Annual
Obligation of the Product.  AMYLIN and BAXTER agree that if AMYLIN
determines to market Product in a cartridge and disposable pen system in addition
to a vial container closure system, then AMYLIN and BAXTER shall negotiate in
good faith to modify this Agreement to include the Production of SYMLIN in the
cartridge/pen system and to amend the Annual Obligations set forth on Exhibit F
and include pricing for such cartridges/pens. 
These good faith negotiations shall include as their objective the
reduction of the number of vial Units and the addition of a number of cartridge
Units in the Annual Obligations specified on Exhibit F with no overall reduction
in the collective number of Units.

4.4                               Order
Increases.  In any two (2) consecutive calendar quarters after the first calendar
year and during the Term of this Agreement, in no event shall BAXTER be
obligated to Produce more than the lesser of (a) [***] ([***]) Units more than
it Produced in the preceding two (2) consecutive calendar quarters and (b) one
[***] ([***]) Units of Product; provided, however,
BAXTER will use good faith efforts to meet such increased demand.

Article 5,  PRICE

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

 

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

 

5.3                                 Purchase
Price Adjustment.  Upon
expiration of the Initial Term or any extension thereof, BAXTER may adjust the
Purchase Price of Product to reflect changes in the cost of materials provided
by BAXTER, labor costs paid by BAXTER in connection with the Production of such
Product, improvements in the manufacturing process, and any other
improvements.  Following the first year
of Regulatory Approval, 

* Confidential Treatment Request(ed)

 

10

 

AMYLIN and BAXTER agree to meet no less than [***] per calendar year to
formally review continuous improvement activities and other improvements
resulting from experience in operating the new process including potential
adjustments in Component or packaging material pricing. AMYLIN and BAXTER shall
work together to obtain process improvements and any net cost savings or
increases achieved by the parties shall be [***], after taking into account any
necessary [***] or [***] costs related to the process improvements and any
current Component, packaging [***] and [***] cost adjustments.  [***] calendar quarters prior to expiration
of the Initial Term or any extension thereof, BAXTER shall provide to AMYLIN
notification of such Purchase Price adjustment. 
If the parties cannot in good faith agree on the proposed Purchase Price
adjustment, the dispute will be discussed between the senior management of both
AMYLIN and BAXTER.  In no event may
BAXTER increase the Purchase Price following the Initial Term by a percent
which exceeds the lesser of (i) the percentage change in the [***] ([***]) for
the previous [***] ([***]) months or (ii) [***] percent ([***]%) of the
original Purchase Price.

 

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

 

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

 

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11

 

                                                actual yield
(“AY”) for Batches Released in any calendar quarter which is lower than EY set
out above, at the end of such calendar quarter, Baxter will reimburse AMYLIN
according to the following formula:

[***];

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

 

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

 

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

 

Article 6,  SHIPMENT AND
INVOICING

 

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

 

6.2                                 Exporter of Record. 
AMYLIN shall be the exporter of record for any Product shipped out of
the United States, as AMYLIN remains the owner of the Product.  AMYLIN warrants that all shipments of Product
exported from the United States will 

 

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                                                be made in
compliance with all applicable United States export laws and regulations and
all applicable import laws and regulations into the country of importation.

 

                                          AMYLIN shall be
responsible for obtaining and paying for any licenses or other governmental
authorization(s) necessary for the exportation from the United States.  AMYLIN shall select and pay the freight
forwarder who shall solely be AMYLIN’s or its agent.  AMYLIN and its freight forwarder shall be
solely responsible for preparing and filing the Shipper’s Export Declaration
and any other documentation required for the export.

 

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

 

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

 

	
  Status

  	
   

  	
  Invoice
  Date

  	
   

  	
  Payment
  Due

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Commercial
  Production

  	
   

  	
  BAXTER’s
  Release 

  	
   

  	
  Invoice
  Date + [***] days

  
	
   

  	
   

  	
  of
  Batch Record

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Regulatory Services

  	
   

  	
  Monthly

  	
   

  	
  Invoice Date + [***] days

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Article 8

  	
   

  	
  Upon notice

  	
   

  	
  Invoice Date + [***] days

  
	
  and Section 5.7 Payments

  	
   

  	
   

  	
   

  	
   

  

 

For
the avoidance of doubt, the process validation Batches will be manufactured
under the Drug Product Development Agreement dated November 7, 2003 and will be
billed according to the terms contained therein.

 

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

 

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

 

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13

 

                                                until AMYLIN
provides assurance of performance reasonably satisfactory to BAXTER.

 

Article 7, 
ACCEPTANCE OF PRODUCT

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

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

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

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

                                                7.2           Remedies
for Non Conforming Product.

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

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

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

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

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

 

Article 8,  TERM AND TERMINATION

8.1                                 Initial
Term.  This Agreement shall be
effective on the Effective Date and shall continue for sixty (60) months
thereafter (the “Initial Term”), unless earlier terminated in accordance with
the terms of this Agreement.  This
Agreement will be renewed automatically for one (1) additional twenty-four (24)
month period commencing at the expiration of the Initial Term and any
extensions thereof unless 

* Confidential Treatment Request(ed)

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                                                either AMYLIN
or BAXTER terminates the Agreement by giving the other party written notice of
intent to terminate at least twenty-four (24) months prior to the expiration of
the Initial Term or any extension thereof. 
The Initial Term as may be extended is referred to herein as the
“Term.”  Except as specifically set forth
in this Article 8, neither party shall have a right to terminate this
Agreement.

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

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

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

8.5                                 Termination Related to Regulatory Compliance.  AMYLIN may terminate this Agreement by giving
ninety (90) days written notice to BAXTER if BAXTER (i) has its manufacturing
authorizations for Product suspended or withheld; (ii) in the case of a PAI for
Product, fails to pass an inspection by a Regulatory Authority due to an act or
omission of BAXTER; or (iii) in the case of a regulatory inspection (which
directly relates to or directly impacts Product) by a Regulatory Authority
fails to pass an inspection and has not completed the corrective action(s)
agreed upon with the Regulatory Authority within the time period agreed upon
with such Regulatory Authority, unless otherwise agreed by BAXTER and AMYLIN.  BAXTER may 

 

16

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

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

8.7                                 Non-cancelable
Costs and Expenses.  In the
event of the termination or cancellation of this Agreement, except by AMYLIN as
a result of a breach by BAXTER under Section 8.2 or by AMLYIN pursuant to
Section 8.3 or 8.5, AMYLIN shall (a) reimburse BAXTER for all actual
out-of-pocket expenses incurred or accrued for all Components ordered prior to
termination and not reasonably usable by BAXTER within six (6) months of
termination not cancelable at no or reduced costs to BAXTER and (b) pay BAXTER
for any work in process or finished goods pursuant to any outstanding Firm
Purchase Orders.  In addition, in the
event of termination or cancellation for any reason other than termination by
AMYLIN pursuant to Sections 8.3 or 8.5, AMYLIN shall pay prices described in
Article 5 for (i) all work-in-process commenced by BAXTER and (ii) all finished
goods of BAXTER.  BAXTER shall ship such
materials to AMYLIN pursuant to Section 6.1. 
AMYLIN shall make payment for all expenses described in this Section 8.6
thirty (30) calendar days from the invoice date.

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

 

Article 9,  PRODUCTION OF PRODUCT

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

 

17

                                                BAXTER will
provide AMYLIN notice, in the event BAXTER is unable to supply Product.

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

9.3                                 Testing.  BAXTER shall test, or cause to be tested by
third party testing facilities as directed by AMYLIN, in accordance with the
Product Specifications, samples of each Batch of Product Produced pursuant to
this Agreement before delivery to AMYLIN. 
A certificate of analysis for each Batch of Product delivered to AMYLIN
shall set forth the items tested by BAXTER, specifications, and test
results.  BAXTER shall send, or cause to
be sent, such certificates along with one (1) copy of the Released Executed
Batch Record and associated documentation described in the Quality Agreement to
AMYLIN prior to or at the same time of shipment of Product to AMYLIN and within
thirty days from the completion date of capping if such Batch requires no
investigations and/or additional testing. 
As required by the FDA and Regulatory Authorities, AMYLIN shall assume
full responsibility for final release of each lot of the Product.

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

 

9.5                                 Permits
and Licenses.  AMYLIN
shall have sole responsibility, at its expense, for obtaining all permits and
licenses necessary or required for the sale, marketing and 

 

18

 

                                                commercialization
of each Product Produced by BAXTER hereunder. 
BAXTER shall be responsible, at its expense, to obtain and maintain all
permits and licenses required for it to carry out its development, regulatory
and Production obligations hereunder.

 

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

 

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

 

9.8                                 Customer
Complaints and Adverse Events: AMYLIN shall maintain all
customer complaint and adverse event files. 
Any such complaints received by BAXTER shall be forwarded to
AMYLIN.  AMYLIN shall be responsible for
the review of the complaint or adverse event to determine the need for an
investigation or the need to report to the applicable Regulatory Authority as
required.  AMYLIN shall send to BAXTER all
Product performance or manufacturing-related complaints which require
investigation and shall provide to BAXTER Product which is the subject of such
complaints in accordance with the Quality Agreement.  If BAXTER receives such returned samples,
BAXTER shall conduct an investigation for each Product performance or
manufacturing-related complaint and shall report findings and follow-up of each
investigation to AMYLIN at no cost to AMYLIN. 
AMYLIN shall make these complaint files available to BAXTER in the event
they are required during an inspection by a Regulatory Authority.  Typical timelines are five (5) calendar days
for notification and twenty-eight (28) calendar days for completion of
investigations.

 

9.9           Changes in
Manufacturing:

 

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

9.9.2                        Product-Specific
Changes.  If facility, equipment,
process or system changes are required of BAXTER as a result of requirements
set forth by the FDA or any other Regulatory Authority, and such regulatory
changes apply solely to the Production and supply of Product, then AMYLIN and
BAXTER 

 

19

 

                                                will review
such requirements and agree in writing to such regulatory changes, and AMYLIN
shall bear [***]% of the reasonable costs thereof.

 

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

 

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

 

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

 

Article 10,  REGULATORY

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

* Confidential Treatment Request(ed)

20

                                                parts of the
CMC section will be provided by AMYLIN to BAXTER upon submission to the
Regulatory Authority.  AMYLIN shall
notify BPS within three (3)  business
days of receipt of an approvable letter. 
Upon Regulatory Approval, AMYLIN will notify BAXTER within three (3)
business days of such approval.

10.2                           Regulatory
Authority Inspections.  At
AMYLIN’s request, BAXTER will authorize Regulatory Authorities to review
related applications on AMYLIN’s behalf. 
BAXTER will notify AMYLIN within two (2) business days of all contacts
with Regulatory Authorities (both written and verbal) related to Product.  BAXTER shall inform AMYLIN of the result of
any regulatory inspection which affects the Production of Product, including any
notice of inspection, notice of violation or other similar notice received by
BAXTER affecting Production, testing, storage or handling of Product.  In the event of an FDA or other Regulatory
Authority inspection which directly involves a Product, AMYLIN shall be
immediately informed of the issuance of the notice of inspection within (1)
business day by telephone and within two (2) business days in writing or
electronically.  In the event that there
are inspectional observations, AMYLIN shall be informed immediately, within (1)
calendar day by telephone and within two (2) calendar days in writing or
electronically and shall have the opportunity to review and provide BAXTER with
comments to BAXTER’s response.  AMYLIN
shall provide its comments to the response of these observations within five (5)
calendar days.  The contents of BAXTER’s
response shall be determined by BAXTER in its sole discretion.

 

 

Article 11,  TRADEMARKS

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

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

 

 

Article 12,  REPRESENTATIONS AND
WARRANTIES

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

 

21

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

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

 

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

 

 

Article 13,  LIMITATION OF
LIABILITY AND WAIVER OF SUBROGATION

 

13.1                           Limitation
of Liability.  AMYLIN’s
sole and exclusive remedies for replacement of non-conforming Product are
limited to those remedies set forth in Article 7.  Under no circumstances shall BAXTER or AMYLIN
be liable for loss of use or profits or other collateral, special,
consequential or other damages, losses, or expenses, 

 

22

                                                including but
not limited to the cost of cover or the cost of a recall, except as
specifically set forth in Article 16, in connection with or by reason of the
Production and delivery of Product under this Agreement whether such claims are
founded in tort or contract.

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

 

Article 14, INDEMNIFICATION

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

 

14.2                           By BAXTER.  BAXTER shall indemnify and hold
harmless AMYLIN and its Affiliates and their respective officers, employees and
agents (“AMYLIN 

 

23

 

                                                Indemnitees”) from and against any and all Losses to which any AMYLIN
Indemnitee may become subject as a result of any Claim arising out of or
related to (a) BAXTER’s breach of any representation or warranty made by BAXTER
in this Agreement or (b) the negligence or willful misconduct of BAXTER in the
Production of Product, except in each case to the extent AMYLIN is obligated to
indemnify BAXTER with respect to such Losses under Section 14.1 or the Losses
are based on the negligence or willful misconduct of any AMYLIN Indemnitee. 

 

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

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

 

 

Article 15,  INSURANCE

15.1                           AMYLIN
Insurance.  AMYLIN
shall procure and maintain, upon receipt of Regulatory Approval, during the
Term of this Agreement and for a period one (1) year beyond the expiration date
of Product, Commercial General Liability Insurance, including without
limitation, Product Liability and Contractual Liability coverage 

 

24

                                                (the “AMYLIN
Insurance”).  The AMYLIN Insurance shall
cover amounts not less than [***] dollars ($[***]) combined single limit and
shall be with an insurance carrier reasonably acceptable to BAXTER.  BAXTER shall be named as an additional
insured on the AMYLIN Insurance and AMYLIN promptly shall deliver a certificate
of AMYLIN Insurance and endorsement of additional insured to BAXTER evidencing
such coverage.  If AMYLIN fails to
furnish such certificates or endorsements, or if at any time during the Term of
this Agreement BAXTER is notified of the cancellation or lapse of the AMYLIN
Insurance, and AMYLIN fails to rectify the same within ten (10) calendar days
after notice from BAXTER, in addition to all other remedies available to BAXTER
hereunder, BAXTER, at its option, may obtain the AMYLIN Insurance and AMYLIN
promptly shall reimburse BAXTER for the cost of the same. Any deductible and/or
self-insurance retention shall be the sole responsibility of AMYLIN.

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

 

Article 16,  RECALL OF PRODUCT

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

 

* Confidential Treatment Request(ed)

 

25

 

	
  Number of Consignees

  	
   

  	
  Recall Class (as classified by Regulatory Authority)

  	
   

  
	
   

  	
   

  	
  I

  	
   

  	
  II

  	
   

  	
  III

  	
   

  
	
  <[***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  N/A

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  N/A

  	
   

  
	
  >[***]

  	
   

  	
  $

  	
  [***]
  per consignee

  	
   

  	
  $

  	
  [***]
  per consignee

  	
   

  	
  N/A

  	
   

  

 

Article 17,  INTELLECTUAL
PROPERTY

 

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

 

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

 

* Confidential Treatment Request(ed)

 

26

 

                                                or medium,
regardless of the media on which contained and whether or not patentable or
copyrightable.

 

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

 

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

 

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

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

 

27

                                                Product
Development and Supply Agreement against AMYLIN or its sublicensees, to use,
make, have made, import, offer to sell, have sold and sell Product.

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

 

Article 18,  CONFIDENTIAL
INFORMATION, NONDISCLOSURE AND PUBLICITY

18.1                           Confidentiality.  This Agreement, by reference, incorporates
the provisions of the Confidentiality Agreement signed by AMYLIN and BAXTER on
October 24, 2003, and is made a part hereof as though fully set forth
herein.  To the extent there is any
discrepancy between the provisions of the Confidentiality Agreement and this
Agreement, the provisions of the Confidentiality Agreement shall prevail. It is
contemplated that in the course of the performance of this Agreement each party
may, from time to time, disclose Confidential Information to the other.  Each party agrees to take all reasonable
steps to prevent disclosure of Confidential Information to third parties.  No provision of this Agreement shall be
construed so as to preclude disclosure of Confidential Information as may be
reasonably necessary to secure from any governmental agency necessary approvals
or licenses or to obtain patents with respect to the Product.

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

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

28

                                                such other
party to secure a protective order or confidential treatment of such
Confidential Information required to be disclosed.

18.4                           Limitation
of Disclosure.  The parties
agree that, except as otherwise may be required by applicable laws,
regulations, rules or orders, including without limitation the rules and
regulations promulgated by the United States Securities and Exchange
Commission, and except as may be authorized in Section 18.5, no information
concerning this Agreement and the transactions contemplated herein shall be
made public by either party without the prior written consent of the other.

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

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

 

Article 19,  FORCE MAJEURE

19.1                           Any delay in
the performance of any of the duties or obligations of either party hereto
(except the payment of money) caused by an event outside the affected party’s
reasonable control shall not be considered a breach of this Agreement, and
unless provided to the contrary herein, the time required for performance shall
be extended for a period equal to the period of such delay.  Such events which are outside a party’s reasonable
control shall include without limitation, acts of God; acts of public enemies;
insurrections; riots; injunctions; embargoes; fires; explosions; floods;
shortages of material or energy which are beyond the reasonable control of
either party; delays in the delivery of raw materials which are beyond the
reasonable control 

 

29

 

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

 

Article 20,  NOTICES

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

	
  If
  to BAXTER:

  	
   

  	
  Baxter
  Pharmaceutical Solutions LLC

  
	
   

  	
   

  	
  927
  South Curry Pike

  
	
   

  	
   

  	
  Bloomington,
  Indiana 47403

  
	
   

  	
   

  	
  Attn:
  Contract Management

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax
  No. 

  	
  812-332-3079

  
	
   

  	
   

  	
  Telephone
  No. 

  	
  812-333-0887

  
	
   

  	
   

  	
   

  
	
  With
  a copy to:

  	
   

  	
  Baxter
  Healthcare Corporation

  
	
   

  	
   

  	
  One
  Baxter Parkway

  
	
   

  	
   

  	
  Deerfield,
  Illinois 60015-4633

  
	
   

  	
   

  	
  Attn:
  General Counsel

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax
  No. 

  	
  (847)
  948-2450

  
	
   

  	
   

  	
  Telephone
  No.

  	
  (847)
  948-2600

  
	
   

  	
   

  	
   

  
	
  If
  to AMYLIN:

  	
   

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9360
  Towne Centre Drive,

  
	
   

  	
   

  	
  Suite
  110

  
	
   

  	
   

  	
  San
  Diego, CA 92121

  
	
   

  	
   

  	
  John
  Grove

  
	
   

  	
   

  	
  Attn:
  Senior Director of Manufacturing

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax
  No.

  	
  (858)
  334-1082

  
	
   

  	
   

  	
  Telephone
  No.

  	
  (858)
  642-7082

  

 

30

 

	
   

  	
   

  	
   

  
	
  With
  a copy to:

  	
   

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9360
  Towne Centre Drive,

  
	
   

  	
   

  	
  Suite
  110

  
	
   

  	
   

  	
  San
  Diego, CA 92121

  
	
   

  	
   

  	
  Attn:
  Vice President and General Counsel

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Telefax
  No. 

  	
  (858)
  552-1936

  
	
   

  	
   

  	
  Telephone
  No. 

  	
  (858)
  642-7066

  

 

 

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

 

Article 21,  APPLICABLE LAW

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

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

 

Article 22,  ASSIGNMENT

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

 

Article 23,  ALLIANCES

23.1                           Notwithstanding
anything to the contrary herein, BAXTER agrees that AMYLIN shall have the right
to enter into alliances with third parties who may engage in joint 

 

31

 

                                                (with AMYLIN)
or unilateral marketing and promoting of the Product or any combination of
products that includes the Product.

 

Article 24,  TAXES

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

 

Article 25,  SUCCESSORS AND
ASSIGNS

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

 

Article 26,  ENTIRE AGREEMENT

26.1                           This Agreement
constitutes the entire agreement between the parties concerning the subject
matter hereof and supersedes all written or oral prior agreements or
understandings with respect thereto.  The
parties agree and acknowledge that the Drug Product Development Agreement dated
November 7, 2003 and corresponding Development Plans and/or Project Plans
thereunder between AMYLIN and BAXTER shall not be superceded by this Agreement
and shall remain in full force and effect.

 

Article
27,  SEVERABILITY

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

 

Article 28,  WAIVER AND
MODIFICATION OF AGREEMENT

32

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

 

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

 

28.3                           No Amendment of Agreement.  In the event that the terms of any Project
Plan, Regulatory Plan, or Exhibit are inconsistent with the terms of this
Agreement, this Agreement shall control, unless otherwise explicitly agreed to
in writing by the parties.  No Project
Plan, Regulatory Plan, or Exhibit shall be deemed to amend this Agreement.  Upon execution of any Project Plan,
Regulatory Plan, or Exhibit, such Plan or Exhibit shall be deemed to be
incorporated herein and by reference and made a part of this Agreement.

 

Article 29,  INDEPENDENT
CONTRACTOR

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

 

Article 30,  ATTORNEY’S FEES

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

 

33

 

 

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

 

	
  “BAXTER”

  	
   

  	
  “AMYLIN”

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  BAXTER
  PHARMACEUTICAL

  	
   

  	
  AMYLIN
  PHARMACEUTICALS, INC.

  
	
  SOLUTIONS LLC

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
  /s/ Joel Tune

  	
   

  	
  By:

  	
   

  	
  /s/ Gregg Stetsko

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
  Joel Tune

  	
   

  	
  Name:

  	
   

  	
  Gregg Stetsko, Ph.D.

  
	
  Title:

  	
   

  	
  Vice President

  	
   

  	
  Title:

  	
   

  	
  Vice President, Operations

  

 

 

34

 

Exhibit
A - Presentations

 

	
  Product Name

  	
   

  	
  BAXTER Item Code

  	
   

  	
  AMYLIN Product

  Reference Number

  
	
  Symlin 5ml Injection Vial (0.6mg/mL) — OMJ

  	
   

  	
  250-102-050-500

  	
   

  	
  110-01

  
	
  Symlin 5ml Injection Vial (0.6mg/mL) —OMJ Professional Samples

  	
   

  	
  250-102-050-501

  	
   

  	
  110-04

  
	
  Symlin 5ml Injection Vial (0.6mg/mL)

  	
   

  	
  250-102-100-500

  	
   

  	
  110-01

  
	
  Symlin 5ml Injection Vial (0.6mg/mL) Professional Samples

  	
   

  	
  250-102-100-502

  	
   

  	
  110-04

  

 

35

 

Exhibit B — Pricing

 

Purchase Price

 

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

 

	
  Annual Volume

  	
   

  	
  250-102-100

  	
   

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

  	
   

  	
  $

  	
  [***]

  	
   

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

  	
   

  	
  $

  	
  [***]

  	
   

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

  	
   

  	
  $

  	
  [***]

  	
   

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

  	
   

  	
  $

  	
  [***]

  	
   

  

*Over [***] units requires scale-up to a higher speed filling line at a
unit cost to be determined.Pricing specified above assumes Production for vials
on Chase-Logeman line (“Line 3”) and includes finishing activities, finished
Product release testing, and assumes manual inspection.  Prices for manufacturing on any other line
will be determined at a later time.  The
initial per Unit price for a higher speed filling line than Line 3 will be no
higher than the corresponding price for the annual volume specified above.

 

Annual Product Quality Review

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

 

Quality Assurance Audits

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

 

Regulatory Support

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

Batch Records

 

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

 

* Confidential Treatment Request(ed)

 

36

distribution of additional executed batch
records in excess of one per year.

 

Storage of Product

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

 

Storage of Components

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

Raw Data

A charge not to exceed $[***] per hour will be paid to BAXTER for raw
data compilation for any data compiled and requested by AMYLIN or as a result
of stability studies performed by BAXTER. 
There will be no charge for initial finished Product raw data which will
be included in the Released Executed Batch Record for the first [***] ([***])
commercial Batches.  Notwithstanding the
foregoing, raw data for rework and reprocessing or stability studies will be
charged at $[***] per hour.

 

* Confidential Treatment Request(ed)

37

Exhibit C - Product Specifications

 

Corporate / Purchasing Specifications for
Pramlintide Acetate Injection in 5 mL Vials

Specification for:                              Pramlintide Acetate Injection in 5 mL Vials, 0.6 mg/mL  LS (AC-0137-F22)

Description:                                                   [***] containing [***]% [***], [***]% [***] in [***] mM [***] (pH [***])

 

SPEC-090, Rev. 07                Effective: 02 May 2003                        

	
  Assay

  	
   

  	
  DESCRIPTION

  	
   

  	
  SPECIFICATION

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  £ [***]%
  ([***]) [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  £ [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  3 [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  Total
  [***]

  	
   

  	
  £ [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  Individual
  [***]

  	
   

  	
  £ [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  £ [***] 3 [***] mm £ [***] 3 [***] mm [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  3 [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  Total
  [***]

  	
   

  	
  £ [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  Individual
  [***]

  	
   

  	
  £ [***]% [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

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

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  £ [***]
  Daltons

  	
   

  
	
  [***] or [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***] or [***]

  	
   

  	
  [***]

  	
   

  	
  <
  [***] EU/mL

  	
   

  

 

* Confidential Treatment Request(ed)

* Client methods are
equivalent to BAXTER SOP’s.

38

Exhibit D — Raw Material and Component Specifications

 

                Formulation and Raw Material
Details

 

	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier Location

  	
   

  	
  Specification

  	
   

  	
  Vendor Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

 

Manufacturing Consumables

 

	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier Location

  	
   

  	
  Specification

  	
   

  	
  Vendor Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

* Confidential Treatment Request(ed)

 

39

 

Primary Component Specifications

 

	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier Location

  	
   

  	
  Specification

  	
   

  	
  Vendor Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

* Confidential Treatment Request(ed)

 

40

 

Packaging Material
Specifications

	
  BAXTER

  Item No.

  	
   

  	
  Material

  	
   

  	
  Supplier

  	
   

  	
  Supplier Location

  	
   

  	
  Amylin Specification

  	
   

  	
  Vendor Assurance

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

* Confidential Treatment Request(ed)

 

41

 

Exhibit E - Regulatory Authorities

 

 

United
States

European
Union

 

42

Exhibit F -  Annual
Obligation

 

	
  YEAR

  	
   

  	
  ANNUAL OBLIGATION

  	
   

  
	
  Year One

  	
   

  	
  0
  Units

  	
   

  
	
  Year Two

  	
   

  	
  [***]
  Units

  	
   

  
	
  Year Three

  	
   

  	
  [***]
  Units

  	
   

  
	
  Year Four

  	
   

  	
  [***]
  Units

  	
   

  
	
  Year Five

  	
   

  	
  [***]
  Units

  	
   

  

 

For
purposes of the Annual Obligation, “Year One” shall mean the calendar year in
which the Agreement is executed, “Year Two” shall mean the year following the
calendar year in which this Agreement is executed, etc. . .

 

* Confidential Treatment Request(ed)

 

43

 

Exhibit G — OMJ Vial Finishing

 

BAXTER
has received and performed a gross inspection of [***] ([***]) lots equaling
[***] OMJ Vials.  BAXTER has also
performed ID testing, using test method [***], on each of the lots
received.  Upon receiving a purchase
order from AMYLIN, pursuant to Section 4.2 of the Commercial Supply Agreement,
BAXTER will schedule, label, package and ship each finished lot of OMJ Vials as
specified in the Project Plans.  The
pricing for the finishing of such vials shall be at a charge of $[***] per
Unit.

 

* Confidential Treatment Request(ed)

 

44

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00079-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00079-of-00352.parquet"}]]