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 


 










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“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 


 










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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 


 










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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 


 










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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 


 










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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.


 










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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)