EXHIBIT 10.62


 


***Text Omitted and Filed Separately

Confidential Treatment Requested

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

And 240.24b-2


 


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


 


AGREEMENT


 


This Agreement
(“Agreement”) is made effective May 12, 2003, by and between Amylin
Pharmaceuticals, Inc., a Delaware corporation having a place of business at
9373 Towne Centre Drive, Suite 250, San Diego, California 92121, USA
(“AMYLIN”) and UCB S.A. a Belgium corporation having a place of business at
[***] (“UCB”). All references to “AMYLIN” and “UCB” shall include their
respective Affiliates.


 


WHEREAS, AMYLIN is
developing and plans to commercialize a peptide referred to as pramlintide
(also referred to as AC137);


 


WHEREAS, UCB and
AMYLIN  previously entered into a
Revised Manufacturing Process Development Agreement effective
September 15, 1993 (“Process Development Agreement”), pursuant to which
UCB developed a solution phase process for the CGMP manufacture of pramlintide;
and UCB, AMYLIN and Johnson & Johnson, a New Jersey corporation having a
place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey
08933 (“J&J”) previously entered into a Scale-Up and Materials Purchase
Contract effective August 30, 1996 (“Scale-Up Agreement”), pursuant to
which UCB scaled up the process for the manufacture of pramlintide developed
pursuant to the Process Development Agreement;


 












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WHEREAS, UCB
previously performed optimization and further scale-up of the solution phase
process for manufacture of pramlintide which was developed under the Process
Development Agreement and the Scale-Up Agreement, and was paid for such
optimization work by J&J under the Release Agreement among UCB, AMYLIN and
various J&J Affiliates (“Release Agreement”);and


 


WHEREAS,
Parties acknowledge that UCB has manufactured CGMP pramlintide pursuant to a
purchase order from Ortho Biotech, Inc. and a purchase order from AMYLIN, both
of which sets of materials were used to validate the manufacturing process used
to manufacture Product (defined below) under this Agreement;


 


WHEREAS, AMYLIN
wishes to purchase from UCB, and UCB is willing to produce for AMYLIN,
quantities of CGMP pramlintide for commercial supply on the terms and
conditions of this Agreement.


 


NOW THEREFORE, in
consideration both of the following premises and terms and conditions set forth
below, the parties agree as follows:


 


ARTICLE I - DEFINITIONS


1.1           “Affiliate” shall mean any entity
that directly or indirectly Owns, is Owned by, or is under common Ownership
with, a party, where “Owns” or “Ownership” means direct or indirect possession
and/or control of at least fifty percent (50%) of the outstanding voting
securities of a corporation or a comparable equity interest in any other type
of entity.


 


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1.2           “Agreement” shall mean this
Agreement, together with all Exhibits and referenced documents.


 


1.3           “Contaminant”
shall mean a substance contained in the Product that (a) causes the
Product to fail to meet Product Specifications, (b) causes the Product to be
adulterated within the meaning of the United States Food, Drug and Cosmetic
Act, as amended, or (c) is present in the Product at a level that exceeds the
level allowed under applicable laws, rules and regulations.


 


1.4           “CGMP”
shall mean current Good Manufacturing Practice requirements that are the part
of quality assurance which ensures that medicinal products are consistently
produced and controlled to the quality standards appropriate for their intended
use (in this case, commercial sale), the principles and guidelines of which are
specified in Chapter II of European Commission Directive 91/356/EEC and Title
21 of the United States Code of Federal Regulations parts 11, 210 and 211 and
ICH Guideline Q7A.


 


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


 


1.6           “Effective Date” shall mean the date
first written above.


 


1.7           “FDA” shall mean the United States
Food and Drug Administration.


 


1.8           “Firm Purchase Order” shall have the
meaning recited in Paragraph 3.4.


 


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1.9           “Joint Inventions” shall mean those
inventions described in Paragraph 7.1.2.


 


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


 


1.11         “Lot” shall mean the pramlintide
lyophilized from a single homogeneous pool of combined fractions of purified
pramlintide.


 


1.12         “Major Change” shall mean (i) a change
that likely will or does significantly affect the quality attributes of Product
or a process, or (ii) a change that results in an amendment to the drug master
file for the Product in the United States, Europe or other countries in the
Region.


 


1.13         Manufacturing Process” shall mean any
and all specifications, compositions, product, formulas, methods, techniques,
processes, procedures and quality control necessary or useful for the scale-up,
manufacture, production, and purification of Product pursuant to CGMP in
commercial volumes with commercially acceptable yields.


 


1.14         “Product” shall mean pramlintide
manufactured in accordance with CGMP which has been completely synthesized and
purified and which meets the specifications recited in the Product
Specifications, attached hereto as Exhibit A.


 


1.15         “Product Specifications” shall mean
those specifications recited in Exhibit A attached hereto.


 


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1.16         “Region” shall mean the United States,
Canada, Mexico and the countries which are members of the European Union and
other countries as may be designated by AMYLIN from time to time during the
term.


 


1.17         “Regulatory Approval” shall mean any
approval, license, registration or authorization of the FDA or other government
entity, necessary for the manufacture, use, storage, import, transport or sale
of Product in a country in the Region.


 


1.18         “Regulatory Authority” shall mean the
FDA or other governmental entity responsible for Regulatory Approval in the
Region.


 


1.19         “Technical Quality Agreement” shall
mean the Technical Quality Agreement dated as of the Effective Date between
AMYLIN and UCB containing, identifying and outlining the specifications, and
certain of the technical and regulatory terms and conditions, for the
manufacture of Product under this Agreement. 
The Technical Quality Agreement is incorporated into this Agreement and
made a part hereof.


 


1.20         “Third Party” shall mean any person or
entity other than UCB or AMYLIN or any of their Affiliates.


 


1.21         “UCB Patents” shall mean pending
applications for patents and issued patents, worldwide, which cover any aspect
of the manufacture of peptide amylin agonists, including pramlintide, which are
owned by UCB or which UCB has the ability to license or sublicense, including
UCB’s interest in patents covering any Joint Inventions.


 


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1.22 “UCB Technology”
shall mean all technical information, whether tangible or intangible and
whether or not patentable, including UCB Patents, and any method, procedure,
process, assay, composition of matter, device, trade secret, invention,
technology, information or other subject matter, including license application
materials and all supporting documents, specifications for materials (including
purification techniques), data, information (including information contained in
registration dossiers, drug master files and other documents filed with
Regulatory Authorities), quality control, validation and equipment necessary or
useful for the manufacture, production, scale-up, processing or formulation of
peptide amylin agonists, including pramlintide, which (a) UCB conceived,
reduced to practice, developed or obtained (or which UCB has the ability to
license or sublicense) in the performance of the Process Development Agreement,
the Scale-Up Agreement, the optimization work paid for under the Release
Agreement, the manufacture of pramlintide under purchase orders from Ortho
Biotech, Inc. and AMYLIN, respectively, or in the manufacture of Product under
this Agreement, or (b) is otherwise necessary or useful in the manufacture of
Product.


 


ARTICLE II - SUPERSEDING EFFECT


 


This Agreement supersedes
all prior oral or written agreements, if any, between or among the parties
regarding the subject matter of this Agreement and constitutes the entire
agreement between or among the parties with respect to the work to be performed
under this Agreement.  In the event of a
conflict between the provisions herein and the Technical Quality Agreement, the
provisions herein will control.


 


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ARTICLE III - COMMERCIAL SUPPLY

OF PRODUCT


 


3.1       Purchase and Supply.  AMYLIN agrees to purchase and UCB agrees to
supply to AMYLIN Product ordered hereunder for commercial sale and use in
clinical trial studies or other use, upon the terms and conditions of this
Agreement.


 


3.2       Pricing.  The price for the Product shall be as stated in Exhibit B,
attached hereto, and incorporated herein by this reference.


 


3.3       Forecast. AMYLIN agrees to provide UCB
with a written rolling [***] forecast of the estimated quantities of Product to
be ordered for delivery by UCB during such [***] period, itemized by [***],
commencing in the [***] during the term. 
All forecasts are not orders, not binding and are only estimates to be
used for planning and scheduling purposes by UCB.  Within thirty (30) days of receiving the [***] estimated
forecast each [***], UCB must notify AMYLIN whether or not manufacturing
capacity issues prevent UCB from supplying the forecasted quantities within the
delivery times forecasted.  UCB will
provide the delivery time corresponding to the forecasted quantities, including
the lead time for the supply of the corresponding raw materials as well as the
possible impact of capacity adjustments or manufacturing flexibility along with
the associated lead times. If UCB notifies AMYLIN that it can not supply the
forecasted quantities within the delivery times forecasted due to manufacturing
capacity issues, then the parties will discuss in good faith possible means to
enable UCB to manufacture such forecasted quantities.  In such case, if requested by UCB, AMYLIN may, in its discretion,
consider pre-purchasing certain long lead time raw


 












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materials.  However, if the parties are unable to agree
on means to enable such


 


manufacture within thirty
(30) days of UCB so informing AMYLIN, AMYLIN may obtain supply of Product from
a Third Party supplier to the extent that UCB cannot supply the forecasted
quantities, in accordance with Paragraph 8.1, Article IX and Article XVII.


 


3.4       Purchase Orders.  AMYLIN will issue a firm purchase order to
UCB for Products ordered under this Agreement (“Firm Purchase Order”).  Firm Purchase Orders issued by AMYLIN under
this Agreement shall be in accordance with the manufacturing and delivery lead
times agreed upon as defined in Paragraph 3.3, and specify the quantities
(including minimum Lot quantity as defined in Paragraph 3.5(a)) and the
delivery dates for the Product ordered. 
The format of the Firm Purchase Order shall be the standard AMYLIN
purchase order form then in effect.


 


3.5       UCB’s Obligations.  Except as set forth in Paragraph 3.3,
UCB shall, at its cost and expense, obtain all raw materials necessary for the
manufacture of the Products ordered by AMYLIN under this Agreement. UCB agrees
to use its best efforts to deliver 100% of all quantities specified in the Firm
Purchase Order at the times and dates set on the Firm Purchase Order, provided,
however, that if UCB uses its best efforts but fails to deliver the quantity of
Product ordered in a Firm Purchase Order, it shall not constitute a breach of
this Agreement if all of (a), (b) and (c) are satisfied –


 


(a)           each Lot of Product delivered by UCB
under the applicable Firm Purchase Order contains at least [***]


 












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of Product or such other
lower minimum Lot quantity as specified in the Firm Purchase Order; and


 


(b)           the total amount of Product actually
delivered under the applicable Firm Purchase Order is at least [***] of the
total amount specified in the applicable Firm Purchase Order; and


 


(c)           over a [***] the total underage of
Product delivered is no greater than [***] of the total amount of Product
specified in the Firm Purchase Orders for delivery in such [***] and provided
that such underage, to the extent that it is greater than [***] of the total
amount of Product specified in the Firm Purchase Orders for delivery in such
[***], is delivered within [***] following such [***].


 


UCB
shall also comply with all of the terms and conditions of the Technical Quality
Agreement.


 


ARTICLE IV - GENERAL SUPPLY
TERMS AND CONDITIONS

FOR SUPPLY OF PRODUCT


 


4.1       General.  The terms and conditions associated with the commercial supply of
Product are as recited in this Article IV.


 


4.2       Manufacture of Product.  UCB represents, warrants and agrees that (a)
UCB shall manufacture Product in accordance with all CGMP requirements and all
other applicable United States and foreign laws, rules and regulations, (b) all
Product shall meet all Product Specifications and shall not contain any
Contaminant; and (c) without prejudice to Article XI.1(d) and XIV.1, UCB
shall only manufacture Product at UCB’s


 












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facility in [***].  Any Lot of Product that does not meet all
Product Specifications, contains any Contaminant or is not manufactured in
accordance with all CGMP requirements or any other applicable United States or
foreign laws, rules and regulations, will not be accepted by AMYLIN.  In an attempt to meet Product Specifications
for each Lot of Product rejected by AMYLIN pursuant to Paragraph 4.5, UCB may
reprocess such material if there is a validated process to reprocess the Lot
and AMYLIN agrees in advance to the reprocessing of the Lot. Product
Specifications shall not be modified without AMYLIN’s prior written
agreement.  UCB shall promptly advise
AMYLIN of any Major Changes, including Major Changes to any processes or
in-process testing proposed by UCB for the manufacture of Product.  No such Major Changes will be implemented by
UCB unless AMYLIN has agreed to such changes in writing in advance.  UCB will not change the vendors of, or the
acceptance criteria for, any raw materials used in the manufacture of Product
without prior approval from AMYLIN.


 


4.3       Testing. On or before the date
specified in each Firm Purchase Order for delivery of each Lot, UCB shall
deliver samples (in sample sizes specified by AMYLIN) of such Lot of Product to
AMYLIN for testing (“Testing Samples”). The Testing Samples will be prepared
and packed by UCB in accordance with AMYLIN’s applicable standard operating
procedures then in effect.  If such Lot
is accepted by AMYLIN in accordance with Paragraph 4.5, UCB shall promptly
deliver the remainder of such Lot of Product (“Commercial Material”) to a
carrier specified by AMYLIN for shipment to the location(s) specified by
AMYLIN.  Each Lot of Commercial Material
will be packed by UCB in accordance with AMYLIN’s applicable standard operating
procedures then in effect.  For any
amendment to such standard operating procedures applicable to shipping Testing
Samples, the associated costs shall be


 












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reviewed in good faith by
the parties and if the parties determine that such amendment results in
significant increased shipping costs, then AMYLIN shall be responsible for
payment of the amount of the increase. 
UCB shall prepare Product for shipment and arrange for shipment of
Testing Samples and Commercial Material. 
AMYLIN shall pay all reasonable delivery charges for Testing Samples and
Commercial Material, provided that such delivery charges are supported with
receipts documenting such delivery charges and that such deliveries were made
in accordance with AMYLIN’s instructions. 
Each shipment must be accompanied by a packing slip which describes the
articles, states the purchase order number and shows the shipment’s
destination.  UCB agrees promptly to
forward the original bill of lading or other shipping receipt for each shipment
in accordance with AMYLIN’s written instructions.


 


4.4       Shipment and Delivery.  The Product to be furnished pursuant to this
Agreement (including both the Testing Samples and Commercial Material
referenced in Paragraph 4.3 above), shall be shipped FCA (Incoterms 2000) UCB’s
facilities, [***]. Each delivery of Product shall be governed by the terms of
this Agreement, and none of the conflicting terms or conditions of AMYLIN’s
Firm Purchase Order form or UCB’s purchase order form, acknowledgment or
invoice form shall be applicable, except those specifying special shipping
instructions and invoice information.


 


4.5       Acceptance of Product.  Not later than ninety (90) days after
receipt of Testing Samples for each Lot of Product, AMYLIN shall examine such
Testing Samples for compliance with the Product Specifications, and any damage,
defects or shortage.  If AMYLIN believes
that any such Testing Samples do not comply with the Product Specifications or
are otherwise deficient, AMYLIN shall promptly, but not later than ninety


 












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(90) days from receipt of
such Testing Samples (which period may be extendible should AMYLIN be able to
justify to UCB that an unusual situation arose which made it not possible for
AMYLIN to determine whether or not the Testing Samples are in compliance with
Product Specifications after receipt of the shipment), notify UCB.  The 90-day period referred to in the
preceding two sentences shall be reevaluated after 2004 to determine whether or
not 90 days is a reasonable period of time. In any case, on or before the end
of 2004, AMYLIN agrees to make its reasonable efforts to reduce this 90-day
testing period.


 


If UCB is satisfied that the relevant Testing Samples
do not comply with the representations and warranties in Paragraph 4.2
(including Product Specifications) or are otherwise deficient, AMYLIN shall dispose
of the non-complying Testing Samples as UCB shall lawfully direct and at UCB’s
sole cost and expense, and UCB shall upon request from AMYLIN, and at AMYLIN’s
option, replace the shipment or remedy the deficiency promptly, at UCB’s sole
cost and expense.  UCB shall not be
liable, however, for any incidental or consequential damages associated with a
non-complying Lot of Product.


 


If UCB should deny that the relevant Lot of Product
does not comply with any of the representations and warranties in Paragraph 4.2
(including Product Specifications) or is otherwise deficient or should admit
such non-compliance or deficiency but deny that it is at fault, UCB and AMYLIN
may submit documentation regarding the relevant Lot of Product to an
independent expert agreed upon by the parties, and the decision of this
independent expert shall be final and binding upon the parties.  The fees of such expert shall be borne by
the losing party.  Failure of AMYLIN to
notify UCB of a claim,


 


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non-compliance or deficiency as set forth under this
Agreement shall constitute acceptance of such Lot of Product subject to
Paragraph 4.6.


 


Title and risk of the
Product will be transferred to AMYLIN upon delivery of the Testing Samples and
the Commercial Material to a carrier specified by AMYLIN as referred to in
Paragraph 4.4 above.


 


4.6           Hidden Defect.  If there is subsequently found to be a
defect in any Lot of Product, which could not reasonably be expected to have
been found by diligent and adequate inspection by AMYLIN pursuant to its
obligations under this Article, such as stability or the presence of any
Contaminant (a “Hidden Defect”), the party discovering the Hidden Defect shall
notify the other party (“Hidden Defect Notice”), and AMYLIN and UCB shall enter
into discussions in good faith about what action should be taken, if any
(including actions as to the handling and disposal of the defective Lot).  If the Hidden Defect is caused by UCB’s
negligence, acts or omissions, then, in addition to any other remedies
available to AMYLIN, AMYLIN shall have the right to require UCB, at AMYLIN’s
election, to either (A) replace the defective Product (any such replacement
shall be at the sole cost and expense of UCB and occur promptly but in no event
later than ninety (90) days after the date of the Hidden Defect Notice), or (B)
refund AMYLIN an amount equal to the price paid by AMYLIN for the defective
Product.


 


4.7           Invoice. 
UCB shall invoice AMYLIN with a single invoice upon delivery of Testing
Samples for each Lot of Product at the address to be specified by AMYLIN in
writing on its Firm Purchase Order. 
AMYLIN shall pay UCB on the earlier of (A) [***] (or if extended based
on an unusual situation


 












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pursuant to Paragraph
4.5, such longer extended time period) of its receipt of the invoice, and (B)
AMYLIN’s acceptance of the Lot; provided that the Lot of Product is not
definitively rejected as described in Paragraph 4.5.


 


4.8           Facilities
Inspection.  In order to
maintain good communication, UCB agrees that AMYLIN shall, upon reasonable
notice, be permitted to have a reasonable number of representatives of its
technical staff present at UCB’s plant at all reasonable times during working
hours, to monitor and participate in the manufacture of Product pursuant to
this Agreement. UCB shall, at all times as may be reasonable, allow AMYLIN
representatives to visit and inspect its manufacturing facilities where Product
is being manufactured and to consult with UCB personnel to discuss and review
the status of the work being done by UCB under this Agreement, and to perform,
at AMYLIN’s expense, quality assurance audits. 
Management of such AMYLIN representatives, including their compensation,
will be the responsibility of AMYLIN. 
AMYLIN shall ensure that its representatives comply with the UCB safety
and access regulations applicable in UCB’s manufacturing facilities, that have
been provided in writing to AMYLIN prior to each visit.


 


ARTICLE V - REIMBURSEMENT FOR [***]


 


5.1  [***]. Within ten (10) days of [***].


 


5.2  Capital Investments. Within ten (10)
days of [***].


 


ARTICLE VI - REGULATORY
COMPLIANCE


 


6.1           Regulatory Approvals. UCB shall make
any and all filings and take any and all other actions with respect to the
Regulatory Authorities, including but not limited to obtaining


 












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and filing all
establishment license applications, necessary master files, registrations, and
validations of manufacturing facility, import and export permits, custom
clearances, currency authorization and other filings (and any permits necessary
therefor), that are necessary for the development of manufacturing processes
for Product, the production of Product for clinical use, commercial sale or
other use in the Region or the transfer of Product to AMYLIN or its designees
as contemplated on this Agreement or as otherwise requested by AMYLIN.  All Regulatory Authority filing, inspection
and other fees, expenses and charges incurred with respect to the validation of
its facilities shall be paid by UCB, unless the validation relates solely to
Product or to the manufacturing process solely applicable to Product, in which
case such fees shall be paid by AMYLIN. 
Timing of the preparation and submission of validation shall be as
determined by AMYLIN in liaison with UCB. 
To the extent permitted by applicable United States and foreign laws,
all regulatory applications shall be filed as instructed by AMYLIN.


 


6.2           Facilities Inspection. UCB shall permit
Regulatory Authorities access to those areas of the manufacturing facilities
where Product is manufactured, stored or handled, and to manufacturing records
of Product manufactured by UCB so that such Regulatory Authorities may perform
an inspection and audit of its facilities and activities (during reasonable
business hours and after reasonable notice).


 


6.3           Compliance with Laws.  AMYLIN and UCB shall observe and comply with
all applicable United States and foreign laws, ordinances, codes and
regulations of government agencies including federal, state, municipal and
local governing bodies having jurisdiction with respect to the manufacture of
Product. UCB shall maintain during the term of this Agreement


 


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all government permits,
including without limitation, health, safety and environmental permits,
necessary for the conduct of the activities and procedures that UCB undertakes
pursuant to this Agreement.


 


ARTICLE VII - OWNERSHIP OF
TECHNOLOGY


 


7.1           Ownership of Inventions.


 


7.1.1 Sole
Inventions.  Each party
shall solely own, and shall have the right to apply for patents, patent rights
and inventor’s certificates within and outside the United States on any
discoveries (whether or not patentable) conceived solely by such party’s
employees, consultants or agents in the performance of this Agreement.  Any employees, consultants and agents
engaged by UCB or AMYLIN (“Engaging Party”) under and in accordance with the
terms of this Agreement, shall be obligated under a written agreement to assign
to the Engaging Party all of such employee’s, consultant’s or agent’s right and
title to discoveries and inventions that such employee, consultant or agent
conceives.


 


7.1.2 Joint Inventions. Joint Invention shall
mean any discoveries (whether or not patentable) conceived jointly by employees
of, or consultants or agents engaged by, AMYLIN and UCB, respectively, in the
performance of this Agreement.  Joint
Inventions shall be jointly owned by AMYLIN and UCB.  The law of joint ownership of patents in the United States shall
apply to ownership of any Joint Invention 
whether in or outside of the United States.  Where appropriate, the parties may engage outside counsel
mutually agreeable to the parties (the costs of which shall be borne equally by
the parties) to represent them jointly in the prosecution of patent


 


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applications and the
maintenance of patents with respect to Joint Inventions.


 


7.1.3 Mutual Grant of Authority.


 


(a)           Should any joint owner of a Joint
Invention (“Grant Party”) not wish to file an application for a patent claiming
such Joint Invention because such filing would result in the disclosure of such
Grant Party’s trade secret as part of the patent application, then the parties
shall discuss in good faith what steps should be taken with respect to such
patent application. In the event the parties do not reach an agreement
regarding the steps that should be taken with respect to such patent
application, then the Grant Party shall decide, at its sole discretion, whether
its trade secret shall be included in such patent application.  Nothing in this Paragraph 7.1.3 (a) however,
shall affect the parties’ respective rights, as joint owners as defined in
Paragraph 7.1.2, to use the Joint Invention.


 


(b)           Subject to Paragraph 7.1.3 (a) above,
should any joint owner of a Joint Invention not wish to file, prosecute,
maintain or issue a patent application or maintain a patent covering such Joint
Invention, then at the other party’s election (the “Receiving Party”), such
joint owner (“Granting Party”) shall grant to the Receiving Party (a) 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 (b) any necessary authority to file, prosecute, maintain, and
issue such a patent application or maintain such a patent, all at the expense
of the Receiving Party.


 


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7.2           Assistance With Patent Protection.  Upon request, AMYLIN and UCB shall each
provide the other with reasonable assistance in obtaining patents and, if
necessary, enforcing patent rights.  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
requesting party in applying for, obtaining, perfecting, evidencing, sustaining
or enforcing the other party’s patent rights. 
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 reasonable compensation
shall be provided and all expenses shall be shared equally by the parties (i.e.,
50% paid by AMYLIN and 50% paid by UCB).


 


7.3           Infringements.  Each party shall promptly notify the other
of and confirm in writing any potential alleged or threatened infringement of
patents covering the manufacture, sale or use of the Products, or of any
allegation by a Third Party that the activity of AMYLIN or UCB pursuant to this
Agreement infringes Third Party patent rights, of which it becomes aware.


 


ARTICLE VIII - LICENSES


 


8.1           UCB License Grant.  UCB hereby grants to AMYLIN a perpetual,
irrevocable, worldwide, fully paid-up royalty-free license under UCB
Technology, with the right to grant sublicenses within the limits defined in
Article 8.2 hereunder, to make, have made, use, import, offer to sell,
have sold and sell peptide amylin agonists including


 


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pramlintide.  This license shall be exclusive (even as to
UCB and its Affiliates) from the Effective Date through the later of (i) [***],
and (ii) the [***], except that during such exclusive period, UCB shall retain
rights to make Product for AMYLIN pursuant to the terms of this Agreement.  The license granted above in this Paragraph
8.1 shall become a non-exclusive license following the period of exclusivity
stated above.


 


8.2           Right to Sublicense.  The right to sublicense to Third Parties is
limited to those situations where (i) there is a  Force Majeure  (Article XVII); (ii) UCB is unable to
supply Product or fails to supply Product ordered under issued Firm Purchase
Orders, and as a result, AMYLIN decides to obtain supply from a Third Party;
(iii) UCB decides that it is unable to supply certain quantities of Product in
a [***] estimated forecast provided by AMYLIN pursuant to Paragraph 3.3; or
(iv) this Agreement is terminated as a result of UCB’s material breach (e.g., UCB is unwilling to supply
quantities of Product).


 


ARTICLE IX - TRANSFER OF UCB
TECHNOLOGY


 


It is understood and
agreed by AMYLIN and UCB that AMYLIN itself or through Affiliates and/or a
Third Party (Third Party manufacture is limited to those specific instances
recited in Paragraph 8.2 wherein AMYLIN has the right to sublicense) may decide
at some point in time to manufacture pramlintide or other peptide amylin
agonists for commercial supply using UCB Technology.  Upon request by AMYLIN, UCB agrees to disclose and transfer to
AMYLIN, its Affiliates and/or a Third Party such UCB Technology as necessary to
enable AMYLIN, its Affiliates and/or a Third Party to manufacture peptide
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pramlintide, according to
the then current manufacturing process being used by UCB.  To facilitate the transfer of such UCB
Technology, UCB agrees to provide to AMYLIN, its Affiliates and/or the
designated Third Party training on-site for the manufacture of peptide amylin
agonists, including pramlintide, using UCB Technology, including on-site instruction
by UCB knowledgeable personnel.  The
party receiving training shall reimburse UCB for travel and living expenses of
UCB employees during the time that they are engaged in the training.  It is anticipated that such training will
take place over a period of six (6) months. 
UCB shall provide the training at no cost for 6 months and thereafter at
a reasonable fee on an FTE basis if additional training is necessary.  The provisions of this Article shall
survive termination or expiration of this Agreement, except in the case of
termination of this Agreement by UCB as a result of material breach by AMYLIN.


 


ARTICLE X - CONFIDENTIALITY


 


10.1         Non-Disclosure.  Subject to the provisions of Articles VIII
and IX, any and all knowledge, know-how, practices, processes or other
information (hereinafter referred to as “Confidential Information”) disclosed
or submitted in writing or in other tangible form which is designated as
Confidential by any party to another party shall be received and maintained in
strict confidence and shall not be disclosed to any Third Party.  Furthermore, the recipient shall not use
said Confidential Information for any purpose other than those purposes
specified in this Agreement.  The
recipient may disclose Confidential Information to employees and/or consultants
requiring access thereto for the purposes of this Agreement; provided, however,
that prior to making any such disclosures, each such employee and consultant
(a) shall


 


20

















 


be apprised of the duty
and obligation to maintain Confidential Information in confidence and not to
use such information for any purpose other than in accordance with the terms
and conditions of this Agreement, and (b) has signed a written agreement with
the recipient not to disclose Confidential Information containing terms
consistent with the terms herein.  Each
party shall take all steps necessary to assure that the Confidential
Information received will be maintained in confidence by such party, including
taking such steps as it takes to prevent the disclosure of its own proprietary
and confidential information of like character.


 


10.2         Exceptions.  The nondisclosure and non-use obligations of this Article X
shall not apply to Confidential Information which, to the extent that the
recipient can establish by competent written proof:


 


(a)           at the time of disclosure is in the
public domain;


 


(b)           after disclosure, becomes part of the
public domain by publication or otherwise, except by breach of this Agreement
by the recipient;


 


(c)           was (i) in the recipient’s possession
in documentary form at the time of disclosure or (ii) subsequently and
independently developed by the recipient’s employees who had no knowledge of or
access to Confidential Information;


 


(d)           was received without restriction on
disclosure by the recipient from a Third Party who has the lawful right to
disclose the Confidential Information; or


 


21

















 


(e)           is required to be disclosed by law or
regulation.  In the event that
Confidential Information is required to be disclosed pursuant to this Paragraph
10.2(e), the recipient shall notify the other party to allow such other party
to assert whatever exclusions or exemptions must be available to it under such
law or regulation.


 


The Article X
obligations for Confidential Information shall be in effect during the term of
this Agreement and for a period of ten (10) years from the expiration or any
earlier termination of this Agreement.


 


10.3         Public Release of Information.  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.


 


ARTICLE XI - REPRESENTATIONS AND
WARRANTIES


 


11.1         Representations and Warranties.  Each party hereby represents and warrants to
the other as follows:


 


(a)           Binding Agreement.  This Agreement is a legal and valid
obligation binding upon it and enforceable in accordance with its terms.  The execution, delivery and


 


22

















 


performance of this
Agreement by it does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.


 


(b)           Validity.  No party is aware of any action, suit or inquiry or investigation
instituted by any federal, state local or foreign governmental agency or
instrumentality which questions or threatens the validity of the Agreement.


 


(c)           Debarments.  Each party represents and warrants that it
and its employees, Affiliates and agents have never been, and does not now and
will not in the future use in any capacity the services of any person, debarred
under subsection (a) or (b) of 21 U.S.C. § 335a.  If during the term of this Agreement, either
party (i) becomes debarred or disqualified, or (ii) receives notice of an
action or threat of an action with respect to debarment or disqualification,
such party shall immediately notify the other party hereunder.


 


(d)           Performance
by Affiliates.  The
parties recognize that each may perform some or all of its obligations under
this Agreement through Affiliates; provided, however, that each party shall
remain responsible and be guarantor of the performance by its Affiliates and
shall cause its Affiliates to comply with such performance and the terms of
this Agreement.


 


(e)           UCB Technology.  UCB represents, warrants and covenants that
it owns or otherwise has rights to all UCB Technology and all other patents,
know-how and other


 


23

















 


proprietary information
and materials which are required to perform its obligations contemplated under
this Agreement.


 


ARTICLE XII - INDEMNIFICATION;
LIABILITY


 


12.1         UCB Indemnification.  UCB hereby agrees to indemnify and hold
AMYLIN (including its Affiliates) and its agents, employees, officers,
directors and insurers harmless from and against any and all suits, claims,
actions, demands, liabilities, expenses and/or losses, including reasonable
legal expense and attorneys’ fees (“Losses”) resulting from any claim by a
Third Party of bodily injury, personal injury or property or other damage,
arising out of (a) UCB’s material breach of, or negligence or intentional
misconduct in performing any of UCB’s activities as contemplated under, this
Agreement, or (b) UCB’s material breach of any representation or warranty under
this Agreement, or (c) any alleged or actual infringement of any patent of any
Third Party arising from use of the UCB Technology as contemplated by this
Agreement, or (d) UCB’s
transportation, storage, use, handling and disposal of hazardous materials
related to its manufacture of Product; but only to the extent that such Losses
in (a), (b),  (c) or (d) above do not
arise from AMYLIN’s negligence, intentional misconduct or material breach of
any representation or warranty under or terms of this Agreement.


 


12.2         AMYLIN Indemnification. AMYLIN hereby
agrees to indemnify and hold UCB (including its Affiliates) and its agents,
employees, officers, directors and insurers harmless from and against any and
all “Losses” resulting from any claim by a Third Party of bodily injury,
personal injury or property or other damage arising out of (a) AMYLIN’s
material breach of or negligence or intentional misconduct in performing any of


 


24

















 


AMYLIN’s activities, as
contemplated under, this Agreement, or (b) AMYLIN’s material breach of any
representation or warranty under this Agreement, or (c) the handling,
possession, or use of the Product or Commercial Product following delivery to a
common carrier pursuant to Paragraph 4.4 (including but not limited to use of
Product in AMYLIN’s clinical trials and AMYLIN’s commercial sale of the
Product; but, only to the extent that such Losses in (a), (b) or (c) above do
not arise from UCB’s negligence, intentional misconduct or material breach of
any representation or warranty under or terms of this Agreement.


 


12.3         Notice.  To the extent an indemnified party makes a claim for indemnification
hereunder, the indemnified party shall give written notice to the indemnifying
party reasonably setting forth the facts and circumstances in connection with
the claim for indemnification.  The
indemnities of this Article XII shall not apply if the indemnified party
fails to give the indemnifying party notice of any claim it receives within 30
days after receipt and such failure materially prejudices the indemnifying
party.  The indemnifying party shall
have the right at its election to take over the defense or settlement of the
Third Party claim at its own expense by giving prompt notice to the indemnified
party.  If the indemnifying party gives
such notice and proceeds so to defend the Third Party claim within 30 days
after receipt of the notice of the Third Party claim, the indemnified party
shall not settle or otherwise compromise the proceedings and shall be bound by
any defense or settlement that the indemnified party may make as to those
claims.  In addition, if the
indemnifying party assumes such control, it shall only be responsible for the
legal fees and litigation expenses of the attorneys it designates to assume
control of the litigation.


 


25

















 


12.4         Special Damages. Notwithstanding
anything to the contrary elsewhere in this Agreement and except for the
indemnification obligations under Paragraphs 12.1 and 12.2, neither AMYLIN nor
UCB shall have any liability whatsoever under this Agreement for any indirect,
incidental, special or consequential damages, including but not limited to loss
of revenue or profit.


 


ARTICLE XIII – NOTICES


 


Any notice required or
permitted hereunder shall be in writing and shall deemed given as of the date
it is (a) delivered by hand, or (b) received by certified mail, postage
prepaid, return receipt requested, or (c) received by an express courier,
postage prepaid, or (d) sent by facsimile with a written confirmation receipt
evidencing the date and time sent, and addressed to the party to receive such
notice at the following addresses:


 


	
  (a)To UCB:

  	
   

  	
  UCB S.A.

  
	
   

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Telephone:

  	
  011-32-2-386-2900

  
	
   

  	
   

  	
  Telefax:

  	
  011-32-2-386-2990

  
	
   

  	
   

  	
   

  
	
  (b)To AMYLIN:

  	
   

  	
  Amylin Pharmaceuticals,
  Inc.

  
	
   

  	
   

  	
  9373 Towne Centre
  Drive, Suite 250

  
	
   

  	
   

  	
  San Diego,
  California  92121

  
	
   

  	
   

  	
  USA

  
	
   

  	
   

  	
  Attention:    John Grove

  
	
   

  	
   

  	
  Senior Director
  Manufacturing

  
	
   

  	
   

  	
  Telephone:

  	
  (858) 642-7082

  
	
   

  	
   

  	
  Telefax:

  	
  (858) 558-0257

  
					



 












*  Confidential Treatment
Request(ed)


 


26

















 


	
  with a copy to:

  
	
   

  	
   

  	
  Amylin Pharmaceuticals,
  Inc.

  
	
   

  	
   

  	
  9373 Towne Centre Drive,
  Suite 250

  
	
   

  	
   

  	
  San Diego,
  California  92121

  
	
   

  	
   

  	
  USA

  
	
   

  	
   

  	
  Attention:     Lloyd A. Rowland

  
	
   

  	
   

  	
  VP and General Counsel

  
	
   

  	
   

  	
  Telephone:

  	
  (858)
  552-2200

  
	
   

  	
   

  	
  Telefax:

  	
  (858) 552-1936

  



 


The address to which
notices should be delivered may be changed from time to time by notice to the
other party as provided in this Article XIII.


 


ARTICLE XIV - ASSIGNMENT AND
SUBCONTRACTING


 


14.1 Assignment by UCB.  This Agreement or any interest hereunder
shall not be assigned or transferred by UCB, without the prior express written
consent of AMYLIN and subject to such terms and conditions that AMYLIN may
impose; provided however, UCB may assign this Agreement without AMYLIN’s prior
express written consent to an Affiliate of UCB, and UCB shall deliver prompt
written notice to AMYLIN of such assignment to its Affiliate. In the event of
UCB’s assignment to a UCB Affiliate, UCB shall remain liable for such
Affiliate’s performance of this Agreement. 
Any consent that AMYLIN elects to provide under this Paragraph 14.1
shall not be provided unless and until UCB furnishes AMYLIN with a copy of the
proposed assignment.


 


14.2 Assignment by AMYLIN.  AMYLIN may assign this Agreement without the
prior express written consent of UCB to (a) a Third Party with whom it enters
into a collaboration, license or similar arrangement relating to the
development and/or commercialization of pramlintide, or (b) a purchaser of
substantially all of the assets of AMYLIN directed to its


 


27

















 


business relating to
pramlintide, or (c) an Affiliate of AMYLIN and AMYLIN shall deliver prompt
written notice to UCB of any such assignment to its Affiliate.  In the event of AMYLIN’s assignment to an
AMYLIN Affiliate, AMYLIN shall remain liable for such Affiliate’s performance
of this Agreement.  Except as provided
in subparts (a) and (b) of this Paragraph 14.2, AMYLIN may not assign this
Agreement to any Third Party without the prior express written consent of UCB.


 


14.3         Subcontracting. UCB shall not
subcontract any of its obligations under this Agreement (including any part or
all of the manufacture of any Product), without the prior express written
approval of AMYLIN.


 


ARTICLE XV - TERM &
TERMINATION


 


15.1         Term. 
This Agreement shall remain in effect, unless earlier terminated pursuant
to the provisions of this Article or Article XVII, for an initial
period of [***] starting from the Effective Date.  Thereafter, it shall be automatically renewed for consecutive
[***] periods unless either party gives written notice at least [***] prior to
the expiration of the initial term or any consecutive renewal period.


 


15.2         Breach.  Either party, at its option, may terminate this Agreement for
default if any of the following acts of default occur: (1) the other party is
in material breach of this Agreement, which breach is not cured within sixty
(60) days of notice of such breach by the terminating party; or (2) the other
party becomes insolvent or a petition under bankruptcy act or similar statute
is filed by or against the


 












*  Confidential Treatment
Request(ed)


 


28

















 


other party and is not
vacated within thirty (30) days after such filing.


 


15.3         AMYLIN Termination.  Upon thirty (30) days prior written notice
to UCB, AMYLIN may terminate this Agreement at any time after the Effective
Date should it determine that the development and/or commercialization of
pramlintide will not continue. 
Termination under this Paragraph 15.3 shall not relieve AMYLIN of its
obligation to purchase Product pursuant to an issued Firm Purchase Order.


 


15.4         Remedies.  The rights and remedies of the parties provided in this
Article XV are in addition to any other rights and remedies provided by
law or under this Agreement.


 


ARTICLE XVI - CALENDAR DATES


 


All periods of days
referred to in this Agreement shall be measured in calendar days.


 


ARTICLE XVII - FORCE MAJEURE


 


If the performance by a
party of any obligation under this Agreement, other than the payment of money,
is prevented or impaired by Force Majeure for any cause beyond the reasonable
control of the defaulting party, such party shall be excused from performance
so long as such situation continues to prevent or impair performance, provided
the party claiming such excuse shall have promptly notified the other party of
the existence, nature, duration and other details of such cause and shall at
all times use its reasonable efforts consistent with its normal business
practices to resume a complete performance. 
If either party anticipates that a


 


29

















 


Force Majeure may occur,
that party shall notify the other party immediately and explain the nature,
details and expected duration thereof.


 


The affected party will
advise the other party from time to time as to the progress in remedying the
situation and as to the time when the affected party expects to resume its
obligations and shall notify the other as to the expiration of any Force
Majeure as soon as the affected party knows the date thereof.


 


“Force Majeure” shall mean
an event beyond the reasonable control of a party including, but not limited
to, fire, flood, sabotage, shipwreck, embargo, explosion, accident, riot, act
of governmental authority, acts of God and acts of war.


 


In the event of a Force
Majeure affecting UCB, UCB may prorate and allocate its supply of manufacturing
resources among its Affiliates and its then current contract customers, and in
such manner as may be deemed fair and reasonable based upon purchases over the
past year.


 


If, as a result of a Force
Majeure event, UCB is unable to supply Product in such quantities as AMYLIN
shall request and in compliance with the delivery periods set forth in this
Agreement, UCB and AMYLIN will consult with each other to determine what
measures to take to solve the supply problem with the understanding that it may
be necessary for AMYLIN to obtain supply from a Third Party source using UCB
Technology in accordance with Article IX, and in such event, AMYLIN shall
be permitted (with no obligation to UCB) to obtain Product from such Third
Party source and require UCB to transfer UCB Technology and provide the
training required and described in


 


30

















 


Article IX.  As soon as the Force Majeure event affecting
UCB’s ability to supply Product terminates, (i) UCB shall provide written
notice thereof to AMYLIN so that AMYLIN may resume issuing Firm Purchase Orders
to UCB in accordance with Paragraph 3.4, and (ii) [***]. If the Force Majeure
event affecting UCB’s ability to supply Product under this Agreement persists
for a period of [***], then AMYLIN shall have the right to terminate this
Agreement by providing written notice to UCB, and the terms of Paragraph 8.2
and Article IX shall apply.


 


ARTICLE XVIII - CHANGES


 


AMYLIN ‘s personnel may,
from time to time, render assistance or give technical advice to, or effect an
exchange of information with UCB’s personnel in a liaison effort concerning the
work hereunder.  However, such exchange
of information or advice shall not vest UCB with authority to change the work
hereunder or the provisions of this Agreement, nor shall any change in the work
or provisions of this Agreement be binding on AMYLIN unless effected as a
modification in accordance with the terms of this Agreement.


 


ARTICLE XIX - HEADINGS; SURVIVAL


 


The headings and
subheadings contained herein are used for convenience and ease of reference and
shall not limit the scope or intent of the clause.  The provisions of Articles VII, VIII, IX, X, XIII, and XX shall
survive any expiration or earlier termination of this Agreement.


 












*  Confidential Treatment
Request(ed)


 


31

















 


ARTICLE XX - INSURANCE


 


Each party will maintain,
at its own expense, insurance coverage for its activities under this Agreement,
consistent with coverage generally held by companies in the pharmaceutical
industry for activities similar to those contemplated under this Agreement.
Each party shall provide the other party with a certificate of insurance if
requested by such other party.  If any
party is required to enter premises owned, leased, occupied by or under the
control of another party during the performance of this Agreement, the visiting
party shall indemnify and hold harmless the visited party, its officers and
employees, from any loss, cost, damage, expense or liability by reason of
property damage or personal injury, including death, of whatsoever nature or
kind arising out of or as a result of such actions of the visiting party or of
its employees during such visit. 
However, the visited party will remain liable for its negligence, if
any.  UCB and AMYLIN shall each maintain
public liability and property damage insurance in reasonable amounts covering
the obligations set forth above and shall maintain the required worker’s
compensation insurance covering its employees.


 


ARTICLE XXI - INDUSTRIAL LAWS
AND BENEFITS


 


In all matters relating
to this Agreement, all parties shall be acting as independent contractors.  Neither UCB nor any of the persons
furnishing Product or performing work or services which are required by this
Agreement are employees of AMYLIN within the meaning of or the application of
any federal, or state unemployment insurance law, or other social


 


32

















 


security, or any worker’s
compensation, industrial accident law, or other industrial or labor law.  At its own expense, UCB shall comply with
such laws, and assume all obligations imposed by any one or more of such laws
with respect to this Agreement.


 


ARTICLE XXII - NOTICE TO AMYLIN
OF POSSIBLE DELAYS


 


Whenever UCB has
knowledge or a reasonable belief that any actual or potential condition is
delaying or threatens to delay the timely performance of this Agreement, it
shall immediately give notice thereof, including all relevant information with
respect thereto, to AMYLIN, and shall identify in detail the steps being taken
to remedy the condition and when such remedy is anticipated to be completed and
delivery accomplished. This Article XXII shall not be deemed a waiver of
any of AMYLIN’s rights under any other Agreement provisions.


 


ARTICLE XXIII - TAXES


 


Unless prohibited by law or otherwise stated to the
contrary in this Agreement, UCB shall pay and has included in the price of this
Agreement, any federal, state or local sales tax, transportation tax, or other
similar levy which is required to be imposed upon the work or items to be
delivered, or by reason of their sale, or delivery.


 


ARTICLE XXIV- MODIFICATION OF
AGREEMENT


 


This Agreement contains all the agreements and
conditions under which the work is to be performed and no


 


33

















 


course of dealing or
usage of the trade shall be applicable unless expressly incorporated in this
Agreement.  The terms and conditions
contained in this Agreement shall not be added to, modified, superseded or
otherwise altered, except by an express written modification signed by
authorized representatives of AMYLIN and UCB.


 


ARTICLE XXV - NO WAIVER OF
CONDITIONS


 


Failure by UCB or AMYLIN
to insist on strict performance with respect to any particular provision of
this Agreement shall not operate or be construed as a continuing waiver of same
or as a waiver of any other provisions of the Agreement


 


ARTICLE XXVI – SEVERABILITY


 


If any provision of this Agreement is declared
invalid, illegal or unenforceable, such provision shall be severed and all
remaining provisions shall continue in full force and effect.


 


ARTICLE XXVII - GOVERNING LAW


 


This
Agreement shall be construed and enforced in accordance with the law of the
State of New York, regardless of its conflict of laws principles.


 


IN
WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed effective as of the date first written above.


 


34

















 


	
   

  	
  AMYLIN PHARMACEUTICALS,
  INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Lloyd A. Rowland,

  
	
   

  	
   

  	
  Vice President and General Counsel

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  UCB S.A.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  UCB, S.A.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  
								



 


35

















 


EXHIBIT
A


Product
Specifications


 


[***]


 












*  Confidential Treatment
Request(ed)


 


A-1

















 


[***]


 












*  Confidential Treatment
Request(ed)


 


A-2

















 


Exhibit
B


 


Pricing
for Product


 


[***]


 












*  Confidential Treatment
Request(ed)


 


B-1