***Text Omitted and Filed Separately


Confidential Treatment Requested


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


And 240.24b-2


 


Exhibit
10.62


 


CONFIDENTIAL


 


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;


 


WHEREAS,  UCB previously performed optimization and
further scale-up of the solution phase process for manufacture


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 

















 


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.


 


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


 


2

















 


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.


 


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


 


3

















 


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.


 


1.16         “Region” shall mean the United States,
Canada, Mexico and the countries which are members of the European


 


4

















 


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.


 


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,


 


5

















 


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.


 


6

















 


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


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


7

















 


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


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


8

















 


(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
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


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


9

















 


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 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


 


10

















 


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 (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


 


* CONFIDENTIAL TREATMENT
REQUEST(ED)


 


11

















 


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


 


12

















 


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 pursuant to Paragraph 4.5,
such longer extended time period) of its receipt of the invoice, and (B) AMYLIN’s
acceptance of


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


13

















 


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 and filing all
establishment license applications, necessary master files, registrations, and
validations of manufacturing


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


14

















 


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 all government permits, including without limitation, health,
safety and environmental permits, necessary for the conduct of


 


15

















 


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


 


16

















 


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.


 


7.2           Assistance
With Patent Protection. 
Upon request, AMYLIN and UCB shall each provide the other with
reasonable


 


17

















 


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 pramlintide.  This license shall be exclusive (even as to
UCB and its Affiliates) from the Effective Date through the later of (i) ten
(10) years from the Launch Date, and (ii) the date


 


18

















 


when the last patent
covering UCB Technology expires, 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 amylin agonists, including
pramlintide, according to the then current manufacturing process being used by
UCB.  To facilitate the transfer of such


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


19

















 


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 be apprised of the duty and obligation to maintain Confidential
Information in confidence and not to use such


 


20

















 


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


 


(e)           is required to be disclosed by law or
regulation.  In the event that
Confidential Information is


 


21

















 


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 performance of
this Agreement by it does not conflict with any agreement, instrument or
understanding, oral or written, to


 


22

















 


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


 


23

















 


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 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


 


24

















 


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.


 


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,


 


25

















 


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.

  
	
   

  	
  [***]

  
	
   

  	
  Director

  
	
   

  	
  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

  
	
   

  	
   

  
	
  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

  
				



 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


26

















 


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 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.


 


27

















 


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 eight (8) years starting from the Effective Date.  Thereafter, it shall be automatically
renewed for consecutive one (1) year periods unless either party gives written
notice at least thirty-six (36) months 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 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


 


28

















 


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 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


 


29

















 


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 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) within sixty (60) days of AMYLIN’s receipt from UCB of
Product ordered under the first Firm Purchase Order issued after the
termination of the Force Majeure event, such Third Party source’s right to use
UCB


 


30

















 


Technology to supply
Product to AMYLIN shall terminate. If the Force Majeure event affecting UCB’s
ability to supply Product under this Agreement persists for a period of 540
consecutive days, 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.


 


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


 


31

















 


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 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.


 


32

















 


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 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.


 


33

















 


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.


 


	
   

  	
  AMYLIN PHARMACEUTICALS,
  INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Lloyd A. Rowland,

  
	
   

  	
   

  	
  Vice President and
  General Counsel

  
	
   

  	
   

  
	
   

  	
  UCB S.A.

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  
						



 


34

















 


	
   

  	
  UCB, S.A.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  	
   

  
						



 


35

















 


EXHIBIT
A


Product
Specifications


 


[***]


 


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


A-1

















 


Product
Specifications


 


[***]


 


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


A-2

















 


Exhibit
B


 


Pricing
for Product


 


[***]


 


 


* CONFIDENTIAL
TREATMENT REQUEST(ED)


 


B-1