Document:

***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.

 

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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

 

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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)

 

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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***Text Omitted and Filed Separately

  
	
  Confidential Treatment Requested

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

  
	
  And 240.24b-2

  

 

Exhibit 10.63

 

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

 

LIMITED
MANUFACTURING AND SUPPLY AGREEMENT

 

This Limited Manufacturing and Supply Agreement (“Agreement”) is
effective as of the 16th day of June, 2003 (the “Effective Date”) by and
between OMJ Pharmaceuticals, Inc., a New Jersey corporation (“OMJ”), with
offices at [***], and Amylin Pharmaceuticals, Inc., a Delaware corporation
(“AMYLIN”), with offices at 9373 Towne Centre Drive, Suite 250, San Diego,
California 92121.

 

WHEREAS, AMYLIN and LifeScan, Inc., an affiliate of OMJ, had been
parties to a Collaboration Agreement dated on or about June 21,1995, which was
terminated;

 

WHEREAS, pursuant to the terms of Section 9.5 of the said Collaboration
Agreement, in the event that LifeScan terminated the said Collaboration
Agreement, LifeScan was to be obligated to “provide for such manufacture of
such Collaboration Products and Royalty Bearing Products to the extent provided
prior to notice of such termination, from the time notice of such termination
is provided until such time as AMYLIN is able to secure an equivalent
alternative commercial manufacturing source, in the event that AMYLIN is unable
to secure such an alternative source during the notice period”;

 

WHEREAS, AMYLIN is currently attempting to secure an equivalent
alternative commercial manufacturing source;

 

WHEREAS, notwithstanding the continuing obligations of the
Collaboration Agreement and the provisions of Section 9.5 of the same, OMJ and
AMYLIN desire that OMJ manufacture and supply to AMYLIN Pramlintide Finished
Product (as hereinafter defined) for only a limited period of time following
the Effective Date, at its facility in [***] in accordance with the terms and
conditions this Agreement;

 

NOW THEREFORE, in consideration of the premises and the mutual
covenants and obligations hereinafter set forth, the parties agree as follows:

 

1.             DEFINITIONS.

 

The following terms, as used in this Agreement, shall have the meanings
set forth in this Section:

 

1.1           “Active Ingredient”
shall mean AMYLIN’ s proprietary peptide, pramlintide (also known as AC137).

 

1.2           “Affiliate” shall
mean any person or entity that, directly or indirectly, controls, or is controlled
by, or is under common control with a party. For purposes of this Agreement,
control means the possession, direct or indirect, or the power to direct or
cause the direction of the management or policies of a party, whether by
ownership of voting securities, by contract or otherwise. Control shall be
presumed where, directly or indirectly, a person or entity owns at least 50% of
the common stock or voting ownership interest of a party.

 

1.3           “Batch” shall mean a
quantity of SKUs (defined below) of Pramlintide Finished Product produced from
a single homogeneous mix.

 

1.4           “CGMPs” shall mean
Current Good Manufacturing Practices as defined from time to time in
regulations promulgated under the Rules Governing Medicinal Products by the
FDCA, or any successor regulations, guidelines or points to consider governing
the manufacture and testing of Pramlintide Finished Product.

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

1

 

1.5           “Completed Batch
Record” shall mean the post-manufacturing documentation of manufacture of
Pramlintide Finished Product, including documentation of equipment and
component preparation, compounding, filling, and packaging of inactive
excipients and Active Ingredient, completed records of formulation,
manufacturing, equipment and component preparation, compounding, dispensing,
in-process testing, filling, microbiological monitoring, inspection, testing
(including sterility and endotoxin 

testing), and labeling, all deviation reports, out-of-specification
investigations, certificates of analysis, and bills of materials.

 

1.6           “Confidential
Information” shall mean all business, technical, and other information of each
party hereunder disclosed by one party (the “Disclosing Party”) to the other
party hereunder (the “Receiving Party”) at any time prior to or during the term
of this Agreement and identified as confidential, together with all records
generated or maintained at the Facility relating to Pramlintide Finished
Product. Confidential Information shall not include information which, as
demonstrated by competent evidence, (i) was known to the Receiving Party prior
to the disclosure; (ii) was generally available to the public at the time of
disclosure or becomes available to the public after disclosure, other than
through any act or omission of the Receiving Party in breach of this Agreement;
(iii) became known to the Receiving Party, without restriction on disclosure,
as the result of disclosure from a third party under no obligation of secrecy
to the Disclosing Party; (iv) is required to be disclosed by law; or (v) where
OMJ is the Disclosing Party, is, in AMYLIN’s reasonable judgment, necessary or
useful for the marketing, promotion, or protection of Pramlintide Finished
Product.

 

1.7           “Disposal” shall mean
any discharge, deposit, injection, dumping, spilling, leaking or placing of any
Waste (as hereinafter defined) into or on any land or water, and the
arrangement of any of the foregoing, and shall include any storage,
pretreatment, treatment (including incineration), use, sale, sampling or other
transfer or application of Waste of any kind or nature whatsoever.

 

1.8           “Facility” shall
mean OMJ’s manufacturing, testing, and storage facility located at [***].

 

1.9           “FDA” shall mean the
United States Food and Drug Administration, and any successor entity thereto.

 

1.10         “FDCA” shall mean the
U.S. Federal Food Drug and Cosmetics Act, as amended, and all regulations
promulgated thereunder.

 

1.11         “Governmental Agency”
shall mean any federal, state, commonwealth or local government agency or
governmental authority that has jurisdiction over the manufacture, testing,
distribution, sale and/or use of Pramlintide Finished Product in the states,
possessions and territories of the U.S.A.

 

1.12         “Laws and
Regulations” shall mean all applicable federal, state, commonwealth, and local
laws, regulations, ordinances, and rules of the states, possessions and
territories of the U.S.A.

 

1.13         “Lot” shall mean a
Batch or a specific, identified portion of a Batch.

 

1.14         “Master Batch Record”
shall mean the pre-manufacturing pre-approved documented instructions for
manufacture of Pramlintide Finished Product, including procedures for equipment
and component preparation, compounding, filling, dispensing formulation,
testing, in-process testing, inspection, end-Pramlintide Finished Product
sampling, labeling, and packaging of inactive excipients and Active Ingredient.

 

1.15         “NDA” shall mean a
New Drug Application, as defined in the FDCA.

 

1.16         “Pramlintide Finished
Product” shall mean the finished dosage form of inactive excipients and Active
Ingredient formulated and filled into a vial container closure system.

 

1.17         “Production Schedule”
shall mean the written schedule for Pramlintide Finished Product mutually
agreed upon by the parties as of the Effective Date, that specifies the
manufacturing dates, quantities to be manufactured, delivery dates and other
information associated with the manufacture of Pramlintide Finished Product
during the term of this Agreement.

 

1.18         “Quality Agreement”
shall mean the Quality Agreement dated August 9, 2001, as amended on the
Effective Date, between AMYLIN and OMJ containing, identifying and outlining
the Specifications, and the technical and regulatory terms

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

2

 

and conditions for the production of Pramlintide Finished Product under
this Agreement. The Quality Agreement is hereby made a part hereof. The Quality
Agreement may be further amended in writing by the parties from time to time
during the term of this Agreement. Unless otherwise defined in a Quality
Agreement, the defined terms therein shall have the same meanings as ascribed
to such terms herein. Any conflict between the provisions of this Agreement and
the provisions of the Quality Agreement will be resolved in favor of this
Agreement.

 

1.19         “Raw Materials” shall
mean any and all raw materials, other than Active Ingredient, needed to produce
package, and label the Pramlintide Finished Product meeting the Specifications
therefore.

 

1.20         “SKU” shall mean a
stock-keeping unit, i.e., a single packaged container closure system containing
Pramlintide Finished Product.

 

1.21         “Specifications”
shall mean the specifications for all Raw Materials, Active Ingredient, and Pramlintide
Finished Product, and the procedures for its manufacture packaging and labeling
mutually agreed upon in writing by the parties, which specifications and
procedures are attached hereto as Exhibit ‘A’ and included as a part of each
Quality Agreement and may be amended from time to time by mutual written
agreement of the parties.

 

1.22         “Waste” shall mean
all materials (except Pramlintide Finished Product that has not been rejected)
that are produced or generated in connection with the manufacture of any
Pramlintide Finished Product, including but not limited to materials that are
hazardous waste, waste waters, residues, bottoms and other remainders, and
obsolete packaging components or materials.

 

2.             MANUFACTURE AND SUPPLY.

 

2.1           OMJ shall manufacture
and supply to AMYLIN the quantities of Pramlintide Finished Product stated in
the Production Schedule from the Effective Date through [***] (the “Expiration
Date”). AMYLIN shall order quantities of Pramlintide Finished Product in full
lot sizes in accordance with the previously agreed upon quantities and delivery
dates stated in the Production Schedule during the term of this Agreement. Any
changes to the said quantities and delivery dates must be mutually agreed upon
by the parties and will be based on plant available capacity. Pramlintide
Finished Product shall comply with the Specifications in effect at the time of
manufacture and shall be manufactured, packaged, labeled, tested, and stored in
accordance with this Agreement at the Facility.

 

2.2           OMJ shall provide
AMYLIN with copies of all documentation and records for all Lots of Pramlintide
Finished Product manufactured for AMYLIN in accordance with Section 3 of the
Quality Agreement and the other terms and conditions of this Agreement.

 

2.3           OMJ shall validate
all equipment, utilities, sterility, processes, and cleaning according to CGMP
and OMJ procedures, all in accordance the Quality Agreement. Upon request by
AMYLIN, OMJ shall perform additional or modified validation procedures, and the
costs therefore shall be allocated between AMYLIN and OMJ as mutually agreed
upon by the parties at such time.

 

2.4           OMJ shall store
Pramlintide Finished Product prior to release at the Facility, [***], and
release and ship each Lot to the location(s) specified by AMYLIN after receipt
of shipment authorization verifying Lot release. OMJ shall also maintain and
store (i) the retained samples of each Lot in accordance with Section 14 of the
Quality Agreement, and (ii) the retained samples of Active Ingredient,
excipients, preservatives, and components, during the term of this Agreement.
Such samples will be turned over to AMYLIN at the end of the Agreement to be
retained and tested by AMYLIN for the remainder-required period based on the
expiration date of the product and AMYLIN’s standard operating procedures.

 

2.5           The parties agree
that OMJ shall manufacture, package, label and store all testing quantities and
all forecasted commercial quantities of Pramlintide Finished Product during
[***] and continue said manufacture until no later than [***]but continue such
packaging, labeling and storage until the earlier of [***]or until such time as
AMYLIN has the ability to package, label and store.

 

3.             RAW MATERIALS; PACKAGING & LABELING.

 

3.1           At least [***] of
Pramlintide Finished Product specified in the Production Schedule, AMYLIN shall
supply OMJ, free of charge at the Facility, with the Active Ingredient required
to produce Pramlintide Finished Product in such quantities as are

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

3

 

necessary to enable OMJ to manufacture the desired quantities of
Pramlintide Finished Product. AMYLIN shall perform the release testing of such
Active Ingredient. A Certificate of Analysis and Release must accompany the
Active Ingredient when received by OMJ from AMYLIN. OMJ shall verify and
document the quantity, condition upon receipt, and identity of Active
Ingredient according to AMYLIN-approved methods and shall inspect Active
Ingredient in accordance with OMJ incoming materials inspection procedures (the
“Inspection Procedures”), a copy of which shall be provided by OMJ to AMYLIN.
OMJ shall notify AMYLIN, and provide AMYLIN with a copy, of any and all changes
to the Inspection Procedures, and if such changes are material, OMJ shall
consult with AMYLIN before any such changes to the Inspection Procedures are
effected. OMJ shall inform AMYLIN, within [***] after receipt of the Active
Ingredient, of any discrepancies noted upon inspection, or in quantity or upon
identity testing of the Active Ingredient discovered by OMJ. OMJ shall also,
within [***] after OMJ’s receipt of the Active Ingredient, inform AMYLIN of any
damage to the Active Ingredient received (e.g., damaged or punctured
containers). Any rejected Active Ingredient shall be returned at AMYLIN’s
expense and direction. OMJ shall store Active Ingredient delivered hereunder in
accordance with the Quality Agreement and Laws and Regulations.

 

3.2           OMJ shall purchase,
receive, and test all Raw Materials from suppliers approved by OMJ and AMYLIN
as described in Appendix II of the Quality Agreement. OMJ shall also provide
microbiological and analytical testing as necessary, storage prior to release,
and maintenance of retained samples of all Raw Materials and Active Ingredient,
as specified in the Specifications and OMJ’s standard operating procedures
(“OMJ SOPs”), a copy of which shall be provided by OMJ to AMYLIN. OMJ shall
notify AMYLIN, and provide AMYLIN with a copy of any and all changes to the OMJ
SOPs. Before any such changes to the OMJ SOPs are effected, OMJ shall consult
with AMYLIN and if such OMJ SOP changes are material to the testing, storage or
maintenance of Pramlinide Finished Product, OMJ shall obtain AMYLIN’s prior
approval prior to effecting such changes.

 

3.3           AMYLIN shall provide
OMJ with the Specifications for Raw Materials, which specifications shall
include, without limitation, the storage, test, and release criteria in
accordance with Appendix II of the Quality Agreement.

 

3.4           AMYLIN shall provide
OMJ with the specifications for all labeling for Pramlintide Finished Product,
which Specifications shall be contained as a part of the Specifications as
defined in Appendix II of the Quality Agreement.

 

3.5           Either OMJ or AMYLIN
may qualify new suppliers for Raw Materials, however neither party shall obtain
Raw Materials from any such supplier unless such supplier has been approved by
both AMYLIN and OMJ in accordance with Section 3.2 above. OMJ and AMYLIN shall
perform periodic audits of existing suppliers as assigned in Appendix II of the
Quality Agreement. At AMYLIN’s request, from time to time during the term, OMJ
shall provide reports to AMYLIN regarding the periodic Raw Material supplier
audits conducted by OMJ. At AMYLIN’s option, AMYLIN may participate jointly
with OMJ in the inspection and qualification of such suppliers.

 

3.6           AMYLIN shall approve
and periodically audit Active Ingredient suppliers.

 

3.7           At AMYLIN’s request,
from time to time during the term, OMJ shall provide AMYLIN with release test
data summary reports for the Raw Materials used to manufacture Pramlintide
Finished Product.

 

3.8           Within ten (10) days
after the end of each calendar month during the term of this Agreement, OMJ
shall provide AMYLIN with a report showing the quantities of Active Ingredient
received during such month, the quantities of Active Ingredient held in
inventory as of the end of such month, quantities of Pramlintide Finished
Product in inventory as of the end of such month, and the quantities of
Pramlintide Finished Product shipped during such month. Such report shall also
indicate the actual conversion ratios of Active Ingredient for Pramlintide
Finished Product manufactured during such calendar month.

 

3.9           OMJ shall be
responsible for packaging and affixing labeling to Pramlintide Finished Product
for the time period specified in Section 2.5.  
Nothing contained herein shall give OMJ any right to use any AMYLIN
trademark except on Pramlintide Finished Product for AMYLIN hereunder, and OMJ
shall not obtain any right, title, or interest in any AMYLIN trademark by
virtue of this Agreement or its performance of services hereunder. OMJ shall
not affix to Pramlintide Finished Product any label, stamp, or other mark
identifying OMJ as the source of Pramlintide Finished Product except as may be
required by applicable Laws and Regulations.

 

4.             PURCHASE ORDERS, INVOICES, DELIVERY.

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

4

 

4.1           Throughout the Term
of this Agreement, AMYLIN shall send firm purchase orders to OMJ, which specify
the quantities and the delivery dates for the Pramlintide Finished Product
ordered (“Purchase Order”). No terms contained in any Purchase Order or
acknowledgment shall be construed to amend or modify the terms of this
Agreement and, in the event of any conflict, this Agreement shall govern and
control.

 

4.2           So long as AMYLIN
sends a Purchase Order to OMJ at least [***] in advance of the delivery date
specified in such Purchase Order, OMJ shall deliver Pramlintide Finished
Product ordered on or before the delivery date specified in such Purchase
Order.  If OMJ cannot deliver on the
delivery date specified in a Purchase Order because of delays occurring with
AMYLIN’s third-party analytical testing lab, then said delivery date will be
delayed for a period of time equal to the said analytical testing labs’ delay.

 

4.3           OMJ shall invoice
AMYLIN for Pramlintide Finished Product simultaneously with shipment
thereof.  Each invoice shall show the
quantity of Pramlintide Finished Product delivered, the invoice date, and the
amount due. Unless otherwise designated in writing by AMYLIN, OMJ shall send
all invoices to the Accounts Payable department of AMYLIN at the address listed
in Section 17.7. AMYLIN shall make payment on invoices in US Dollars not later
than [***] after AMYLIN receives the invoice therefore from OMJ. No terms
contained in any invoice shall be construed to amend or modify the terms of
this Agreement and, in the event of any conflict, this Agreement shall govern
and control.

 

4.4           Title to all Active
Ingredient remains with AMYLIN. Title to all Pramlintide Finished Product
(excluding the Active Ingredient contained therein) shall remain with OMJ until
delivery to the common carrier designated by AMYLIN, at which time title will
transfer to AMYLIN.

 

5.             PRICE.

 

The purchase price for Pramlintide Finished Product is set forth in
Exhibit ‘B’, which is attached hereto and made a part hereof, and shall remain
in effect for the term of this Agreement. The purchase price includes, without
limitation, procurement, storage, product production, quality control, quality
assurance, manufacturing support operations, and all other functions necessary
to assure that Pramlintide Finished Product is produced in a timely fashion and
in accordance with the Master Batch Records, associated testing results, shelf
cartons, shippers and shipper labels, and the terms and conditions of this
Agreement. In addition to the purchase price set forth in Exhibit ‘B’, AMYLIN
will reimburse OMJ for all the expenses incurred to complete the validation
activities required to comply with the Laws and Regulations, trials and any
other experimental activity that AMYLIN may request OMJ to perform. OMJ will
provide estimates and will seek AMYLIN’s approval before incurring on such
expenses on behalf of AMYLIN.

 

6.             REGULATORY AND QUALITY ASSURANCE MATTERS.

 

6.1           OMJ and AMYLIN agree
to comply with the terms and conditions of the Quality Agreement.

 

6.2           OMJ shall
manufacture, fill, provide 100% visual inspection, package, label and test
Pramlintide Finished Product purchased hereunder in accordance with the
Specifications, the Master Batch Record, CGMPs, the terms and conditions of the
Quality Agreement, and all applicable Laws and Regulations. OMJ shall conduct
the in-process testing of Pramlintide Finished Product (which in-process
testing is described in the Specifications) and environmental monitoring of the
Facility before, during, and after manufacture of each Lot of Pramlintide
Finished Product. All test results, manufacturing records, and reports shall
promptly be reduced to writing. OMJ shall notify AMYLIN immediately of any test
failures noted during the manufacture of Pramlintide Finished Product; and,
AMYLIN shall have access to all such test results, investigation reports, and
records, and any Lot samples within [***] of any request for the same to OMJ.

 

6.3           AMYLIN shall
identify those Lots of Pramlintide Finished Product that shall be entered into
the stability program. OMJ shall, in accordance with AMYLIN’s instructions and
the Quality Agreement, remove the appropriate number of labeled SKU’s from each
Lot identified by AMYLIN as a stability Lot, and ship such SKU’s to AMYLIN at
AMYLIN’s expense, as directed by AMYLIN.

 

6.4           OMJ shall promptly
notify AMYLIN of any problems or unusual production, supply, or other
situations that are likely to adversely affect the production of any
Pramlintide Finished Product, or its timely delivery to AMYLIN in accordance
with the Purchase Order for the same, including, without limitation, any
process deviations as described in the Quality Agreement. AMYLIN may, at its
discretion, participate in the resolution of any such problem or production
situation.

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

5

 

6.5           Either of the
parties may initiate change requests to the Specifications or changes to the
Pramlintide Finished Product manufacturing processes in accordance with Section
5 of the Quality Agreement, with costs paid as follows.

 

6.5.1        In
the event AMYLIN requests any such changes be made, other than changes
requested by any Governmental Agency or required to bring the Facility into
compliance with applicable Laws and Regulations, AMYLIN and OMJ shall, to the
extent technologically feasible, accommodate AMYLIN’s requested changes,
provided that AMYLIN shall reimburse OMJ for any reasonable incremental
one-time costs associated with such changes.

 

6.5.2        In
the event OMJ requests any such changes be made, other than changes requested
by any Governmental Agency or required to bring the Facility into compliance
with applicable Laws and Regulations, all costs associated with such changes
shall be the sole responsibility of OMJ.

 

6.5.3        The
one-time and on-going incremental costs associated with any change to the
Specifications which are required or requested by any Governmental Agency shall
be paid by AMYLIN, unless such change is required to be made to bring the
Facility into compliance with applicable Laws or Regulations, in which case the
costs associated with such change shall be the sole responsibility of OMJ.

 

6.6           No aspect under
which Pramlintide Finished Product is manufactured under this Agreement may be
changed without the mutual express written consent of AMYLIN and OMJ.

 

6.7           CGMP compliance
responsibilities are set forth in the Quality Agreement.

 

6.8           The conditions under
which Pramlintide Finished Product is manufactured shall be provided to AMYLIN
for inclusion in AMYLIN’s regulatory filings in the U.S. OMJ further agrees to
provide to AMYLIN all information regarding any aspect of manufacture of
Pramlintide Finished Product that is necessary and related to AMYLIN’s
regulatory filings. OMJ also agrees to authorize appropriate U.S. & P.R.
Governmental Agencies, to inspect any aspect of OMJ’s manufacture of
Pramlintide Finished Product. In the event that OMJ is notified of any
potential plant inspection from any Ex- U.S. Regulatory Agency as a result of
any Regulatory filing, AMYLIN agrees to withdraw such filing immediately.

 

7.             RELEASE AND REJECTION OF PRAMLINTIDE FINISHED
PRODUCT.

 

7.1           Prior to delivery of
Pramlintide Finished Product to AMYLIN hereunder, OMJ shall provide AMYLIN with
the following:

 

(i)            Within
[***] of the date of manufacture of such Pramlintide Finished Product, OMJ
shall ship sample vials of the Batch for such Pramlintide Finished Product, to
AMYLIN in the amounts requested by AMYLIN as described in the Quality
Agreement;

 

(ii)           Within
[***] of the manufacture date, OMJ shall provide AMYLIN with (A) the Completed
Batch Record, (B) in-process and microbiological test results, and C) a
Certificate of Compliance.

 

After OMJ ships sample vials, the Completed Batch Record, and the
Certificate of Compliance to AMYLIN, AMYLIN shall have [***] from receipt of
such sample vials and documentation to accept or reject such Batch of
Pramlintide Finished Product. In the case of a latent defect in Pramlintide
Finished Product delivered by OMJ to AMYLIN hereunder, AMYLIN shall have [***]
from AMYLIN’s discovery of such latent defect to reject such Batch of
Pramlintide Finished Product. AMYLIN may reject a Batch of Pramlintide Finished
Product if (i) such Batch of Pramlintide Finished Product fails to meet the
Specifications or is otherwise deficient (including having characteristics not
specifically authorized by the Specifications), or (ii) the process used to
manufacture such Batch of Pramlintide Finished Product deviates from the Master
Batch Record. Failure of AMYLIN to reject a Batch of Pramlintide Finished
Product as set forth above shall constitute acceptance thereof.

 

7.2           Any claim submitted
by AMYLIN pursuant to Section 7.1 hereof must be accompanied by an
investigation report (including an adequate Pramlintide Finished Product sample
from the Batch of Pramlintide Finished Product analyzed), and shall be handled
as hereafter set forth in this Section 7.

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

6

 

7.3           Should AMYLIN reject
any Batch pursuant to Section 7.1 and OMJ agree that such rejection is
justified, OMJ shall promptly, at AMYLIN’s option, either reimburse AMYLIN for,
or provide AMYLIN with a credit totaling, any purchase price paid for such
Batch of Pramlintide Finished Product.

 

7.4           Should AMYLIN reject
any Batch pursuant to Section 7.1 and OMJ, after good faith negotiation, fails
to agree that such rejection is justified, the parties shall mutually agree on
an independent third party to evaluate all documentation of testing and
manufacturing relating to such Batch of Pramlintide Finished Product and other
relevant information developed by both parties relating thereto to ascertain
whether the rejection is justified. If the third party determines that AMYLIN’s
rejection is justified, OMJ shall undertake the same actions detailed in
Section 7.3 above. The party against which such third party rules shall bear
the costs of such testing.

 

7.5           If a Batch of
Pramlintide Finished Product is rejected, the parties shall immediately discuss
what appropriate steps must be taken to secure disposition of the rejected
Pramlintide Finished Product. If a

rejected Batch of Pramlintide Finished Product is at OMJ’s facility,
then, unless otherwise directed by AMYLIN, such rejected Batch of Pramlintide
Finished Product shall be delivered to AMYLIN or destroyed by OMJ in accordance
with all applicable Laws and Regulations, at OMJ’s expense.

 

7.6           If the number of
units of Pramlintide Finished Product delivered by OMJ to AMYLIN pursuant to a
Purchase Order is less than the number of units ordered under such Purchase
Order, then the parties shall immediately discuss what appropriate steps must
be taken to secure manufacture and delivery of the remaining units of
Pramlintide Finished Product that have not been delivered.

 

8.             SHIPMENTS AND RISK OF LOSS.

 

8.1           Within [***] of
signing this Agreement, AMYLIN shall provide OMJ with written instructions to
follow in shipping Pramlintide Finished Product. OMJ shall hold the Pramlintide
Finished Product in refrigerated storage as required in the Specifications, until
the Pramlintide Finished Product is released by Quality Assurance, and shall
prepare and arrange the shipment of Pramlintide Finished Product as designated
by AMYLIN in AMYLIN’s Purchase Order. OMJ shall coordinate shipments of
Pramlintide Finished Product to those locations designated by AMYLIN. Where
shipping validation is required, AMYLIN shall be primarily responsible for
developing such shipping method. Notwithstanding the above, at no point will
OMJ commit to have more than [***] stored at its Facility due to existing
refrigeration capacity limitations. Accordingly, AMYLIN will secure sufficient
refrigerator capacity to hold this Pramlintide Finished Product at AMYLIN’s
premises or contracted warehouse until the Pramlintide Finished Product is distributed.
OMJ will not hold any excess inventory for AMYLIN beyond the agreed delivery
date unless the parties agree to and OMJ is compensated by AMYLIN accordingly.
The risk of loss during the extended storage period belongs to AMYLIN. All
shipments of Pramlintide Finished Product are FCA (Incoterms 2000) the
Facility.

 

8.2           OMJ shall prepare
all shipping documents, which shall reference the Purchase Order number, Lot
number, expiration date, shipping conditions, and any other document necessary
to comply with Laws and Regulations. Each pallet shall have a release or
quarantine sticker affixed thereto. Upon delivery to a carrier approved by
AMYLIN, title to Pramlintide Finished Product shall pass to AMYLIN and AMYLIN
shall assume and bear all risk and liability with respect to the loss or damage
of Pramlintide Finished Product(s).

 

8.3           OMJ shall notify
AMYLIN that a shipment is in transit by Purchase Order number, Lot number,
manufacture date, Pramlintide Finished Product, and quantity within twenty-four
(24) hours after the shipment was accepted by an AMYLIN-authorized carrier.

 

8.4           Title to all unused
Active Ingredient shall at all times remain in AMYLIN, and OMJ shall not
subject any Active Ingredient to any liens, claims, and encumbrances while it
is in its custody. Title to all work in process to produce Pramlintide Finished
Product and all completed Pramlintide Finished Product (excluding the Active
Ingredient contained therein) shall remain with OMJ until delivery to the
common carrier designated by AMYLIN, at which time title will transfer to
AMYLIN.

 

8.5           OMJ shall have no
liability to AMYLIN in respect of any loss, damage or destruction relating to
the Active Ingredient prior to the same being delivered to the Facility.

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

7

 

9.             IMPROVEMENTS; CONFIDENTIALITY.

 

9.1           Any inventions and
improvements to the manufacturing processes or know-how related to Pramlintide
Finished Product, whether made or conceived by OMJ or AMYLIN or both, shall be
owned by, and the exclusive property of, AMYLIN.

 

9.2           During the term of
this Agreement and for a period of five (5) years after the expiration or
earlier termination of this Agreement, neither party shall:

 

(i)            Disclose,
publish, or make available any Confidential Information of the Disclosing Party
disclosed to it by the Disclosing Party, to any third party or to any employee
of the Receiving Party who has no need to know or to have access to such
Proprietary Information; or

 

(ii)           Sell,
transfer, or otherwise use or exploit any such Confidential Information of the
Disclosing Party.

 

The Receiving Party shall use the Disclosing Party’s Confidential
Information solely for purposes of performing its obligations under this
Agreement. Upon the expiration or earlier termination of this Agreement, the
Receiving Party shall return to the Disclosing Party the originals and all
copies of the Disclosing Party’s Confidential Information then in its
possession, provided however, the Receiving Party shall have the right to
retain one copy of such Confidential Information in a secure location for the
sole purpose of determining the scope of the obligations incurred under this
Agreement.

 

10.           COMPLIANCE WITH LAW.

 

OMJ and AMYLIN shall at all times comply with all applicable laws,
regulations, government permits and approvals relating to the manufacture,
storage, handling, transportation and use of Active Ingredient and Pramlintide
Finished Product. In the event a Governmental Agency forces the cessation of
the Facility’s operations due to any actual or alleged violation or act(s) of
noncompliance with Laws or Regulations by OMJ, OMJ shall use diligent efforts
to cure such violation or non-compliance and to resume operation as soon as
possible.

 

11.           TRANSFER OF MANUFACTURING PROCESS.

 

11.1         It is understood and
agreed by AMYLIN and OMJ that AMYLIN itself and/or a third party may at some
point in time manufacture Pramlintide Finished Product using the Master Batch
Record and that AMYLIN (or its designee) shall be entitled to a complete copy
of the Master Batch Record upon request.

 

11.2         To facilitate the
transfer of the manufacturing process in accordance with Section 11.1, OMJ
agrees to provide to AMYLIN, or the relevant third party, training on-site (at
AMYLIN’s or such third party’s premises) for the manufacture of Pramlintide
Finished Product for an appropriate period, such training including but not
limited to on-site instruction by a reasonable number of OMJ knowledgeable
personnel provided such individuals are still employed by OMJ. The party
receiving training shall reimburse OMJ at OMJ’s full daily charge out rate for
the personnel providing such training and for reasonable travel and living
expenses of OMJ employees during the time that they are engaged in the
training. Provisions of this Section 11 are applicable during the term of this
Agreement and shall survive termination or expiration until such time as OMJ
has transferred to AMYLIN or its designee such information and training as is
reasonably necessary for the manufacture of Pramlintide Finished Product in
accordance with the Master Batch Record.

 

12.           WASTE.

 

OMJ shall assume responsibility for disposing of any and all Waste
generated during the process of manufacturing and packaging Pramlintide Finished
Product in accordance with all Laws and Regulations. Copies of all
documentation, evidencing all Disposals by OMJ, shall be made available in the
Facility to AMYLIN upon reasonable request.

 

8

 

13.           WARRANTIES.

 

13.1         OMJ hereby warrants
that all Pramlintide Finished Product supplied to AMYLIN hereunder, (i) shall
have been manufactured at the Facility in accordance with the Specifications
and the Master Batch Record; (ii) upon delivery to AMYLIN, shall be in
compliance with the Specifications therefore and with all applicable
requirements of the FDCA (including but not limited to CGMPs) and all other
applicable Laws and Regulations, and be free from any deleterious materials;
(iii) upon delivery to AMYLIN, shall not be adulterated or misbranded within
the meaning of the FDCA or any applicable state, Puerto Rican, or other
applicable Laws and Regulations in which the definitions of adulteration or
misbranding are substantially the same as in the FDCA, as such Laws and
Regulations are constituted and effective at the time of delivery), and will
not be an article which may not, under the FDCA or any other applicable Laws
and Regulations, be introduced into interstate commerce; and (iv) shall be in
undamaged containers.

 

13.2         OMJ further warrants
that: (i) it has the right to enter into this Agreement; (ii) it has all
government permits and approvals necessary to conduct operations at the
Facility and is in compliance therewith; (iii) it has adequate facilities to
undertake the obligations set forth herein; (iv) it shall comply with all
applicable Laws and Regulations relating to the manufacture, assembly and
supply of the Pramlintide Finished Product, including, without limitation,
those enforced by the FDA (including, without limitation, compliance with
CGMPs); (v) the Facility and its operation comply in all material respects with
all applicable building codes and ordinances; and (vi) it owns all right, title
and interest in all manufacturing processes used in the manufacture of the
Pramlintide Finished Product, and the use of such manufacturing processes for
the manufacture of the Pramlintide Finished Product as contemplated by this
Agreement shall not infringe any patent or other intellectual property right of
any third party.

 

13.3         OMJ warrants that it
and its employees, affiliates and agents have never been (i) debarred, or (ii)
convicted of a crime for which a person can be debarred, under subsection (a)
or (b) of 21 U.S.C. § 335a, as amended, and OMJ agrees that it 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, OMJ or any other person performing hereunder (y) becomes debarred or
disqualified, or (z) receives notice of an action or threat of an action with
respect to debarment or disqualification, OMJ shall immediately notify AMYLIN.

 

14.           TERM AND TERMINATION.

 

14.1         The term of this
Agreement shall commence as of the Effective Date and, unless earlier
terminated as provided hereunder, shall expire on the Expiration Date.

 

14.2         This Agreement may be
terminated

 

(i)                                     by
either party (the “Terminating Party”) upon written notice if:

 

(A)       the other party fails to
perform a material obligation or violates any provision of this Agreement in a
material respect, and such party does not cure such failure to perform or
violation within thirty (30) days after receiving written notice from the
Terminating Party or, if the nature of the default is such that it cannot be
cured within such thirty (30) day period, such party has not diligently
proceeded to effect the cure of said breach within said thirty (30) day period;

 

(ii)                                  by
AMYLIN upon providing written notice to OMJ if:

 

(A)       a Force Majeure Event
(as defined below) prevents OMJ from performing its obligations hereunder for
three (3) consecutive months in accordance with Section 15 below; or

 

(B)        a Governmental Agency
forces the cessation of the Facility’s operations pursuant to Section 10 above;

 

(C)        OMJ receives notice
from the PDA or other regulatory authority that OMJ has failed to successfully
complete its pre-approval inspection or equivalent non-United States
inspection, and therefore is not an approved commercial supplier of Pramlintide   ‘ Finished Product in such country; or

 

(D)       AMYLIN withdraws the NDA
or equivalent non-United States applications directed to the Pramlintide
Finished Product.

 

9

 

14.3         The expiration or
earlier termination of this Agreement shall not relieve either party from
liabilities and obligations accrued prior to the effective date of termination,
including OMJ’s obligation to produce Pramlintide Finished Product ordered and
AMYLIN’s obligation to pay for Pramlintide Finished Product delivered, up to
the effective date of termination.

 

14.4         Upon cessation of
AMYLIN’s purchases of any Pramlintide Finished Product hereunder (including,
without limitation, pursuant to Section 15), or the expiration or any earlier termination
of this Agreement, OMJ shall (i) transfer to AMYLIN, at AMYLIN’s expense, all
documents, records, and retained samples relating to such Pramlintide Finished
Product, except one copy of such records which may be retained by OMJ, at OMJ’s
expense, for archival purposes; and (ii) provide all required assistance to
transfer manufacturing processes for such Pramlintide Finished Product to
AMYLIN, or at AMYLIN’s request, a designee of AMYLIN, pursuant to Section 11.

 

15.           FORCE MAJEURE.

 

Neither party shall be liable to the other for loss or damages for any
default or delay attributable to any cause beyond the reasonable control of
that party, including but not limited to, an act of God, flood, fire,
explosion, earthquake, war, revolution, civil commotion, act of a public enemy,
blockade, or embargo (“Force Majeure Event”). The affected party shall exercise
diligent efforts to resume performance of its obligations as soon as possible
and shall provide the other party with prompt written notice when it is able to
resume performance.

 

16.           INDEMNIFICATION.

 

16.1         AMYLIN shall defend,
indemnify, and hold harmless OMJ, its Affiliates, and their respective
officers, agents, and employees, from any loss, damage, expense, or liability
(including without limitation defense costs and reasonable attorneys’ fees) in
connection with any claim, lawsuit or other action by a third party (the “OMJ
Claim”) resulting from the breach of any representation, warranty, covenant, or
agreement made by AMYLIN in this Agreement or the handling, possession, or use
of Pramlintide Finished Product following delivery to a common carrier pursuant
to Section 8, unless and to the extent that such OMJ Claim is based on, arises
out of, or is due to the breach of this Agreement by, or the negligent or
wrongful acts or omissions of, OMJ, its Affiliates or any of their respective
officers, agents, or employees.

 

16.2         OMJ shall defend,
indemnify, and hold harmless AMYLIN, its Affiliates, and their respective
officers, agents, and employees, from any loss, damage, expense, or liability
(including without limitation defense costs and reasonable attorneys’ fees) in
connection with any claim, lawsuit or other action by a third party (“Amylin
Claim”) resulting from the breach of any representation, warranty, covenant, or
agreement made by OMJ in this Agreement or the manufacture, storage, handling,
possession, or use of Active Ingredient or Pramlintide Finished Product prior
to delivery to a common carrier pursuant to Section 8, unless and to the extent
that such Amylin Claim is based on, arises out of, or is due to the breach of
this Agreement by, or the negligent or wrongful acts or omissions of, AMYLIN,
its Affiliates, or any of their respective officers, agents, or employees.

 

17.           MISCELLANEOUS.

 

17.1         No Publicity.
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.

 

17.2         Further Action.
The parties agree to execute, acknowledge, and deliver such further instruments
and to do all such incidental acts as may be reasonably necessary or
appropriate to carry out the purpose and intent of this Agreement.

 

17.3         Independent
Contractors. Nothing in this Agreement is intended or shall be deemed to
constitute a partnership, agency, employer-employee or joint venture
relationship between the parties. All activities by the parties hereunder shall
be performed by them as independent contractors. Neither party shall incur any
debts or make any commitments for the other party.

 

10

 

17.4         Headings. The
parties agree that the headings in this Agreement are used for the convenience
of the parties only and are not intended to be used in the interpretation of
this Agreement.

 

17.5         Survival. The
expiration or earlier termination of this Agreement shall not relieve either
party from full performance of any obligations incurred prior thereto. The
terms and conditions of Sections 7, 8, 9, 11, 12, 13, 14.3, 14.4, 16 and 17
hereof shall survive the early termination or expiration of this Agreement.
This provision will not be construed to limit the survival of any other
provisions that also survive the termination or expiration of this Agreement by
the express or implied terms of such provisions.

 

17.6         Entire Agreement;
Modification. The terms of this Agreement, together with the Exhibits
attached hereto and the Quality Agreement, represent the entire agreement of
the parties with respect to the subject matter herein superseding any and all
prior and contemporaneous agreements, whether written or oral, with respect
thereto, and the same shall not be modified or supplemented except in a written
document duly executed by the parties, which document shall state that it is a
modification to this Agreement. In the event of any inconsistencies between the
terms and conditions of this Agreement, and the terms and conditions of any
purchase order, acknowledgement, invoice, or other form utilized by the
parties, the terms and conditions of this Agreement shall govern and control.

 

17.7         Notices. All
notices and other communications provided for by this Agreement shall be given
in writing, and shall be deemed to have been given if: (a) personally delivered
by hand; (b) sent by overnight courier; (c) sent by certified or registered
mail, return receipt requested; or (d) sent by facsimile (and confirmed in
writing by any of the foregoing methods), to the intended recipient as follows
(or such other address and facsimile number as each party may designate in
writing to the other party):

 

	
  If to AMYLIN:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Amylin Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9373 Towne Centre Drive, Suite 250

  
	
   

  	
   

  	
  San Diego, California 92121

  
	
   

  	
   

  	
  Attention: John D. Grove

  
	
   

  	
   

  	
  Facsimile: 858-334-1082

  
	
   

  	
   

  	
   

  
	
   

  	
  with a copy to:

  	
   

  	
  Lloyd A. Rowland

  
	
   

  	
   

  	
  Vice President and General Counsel

  
	
   

  	
   

  	
  Amylin Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  9373 Towne Centre Drive, Suite 250

  
	
   

  	
   

  	
  San Diego, California 92121

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: 858-552-1936

  
	
   

  	
   

  	
   

  
	
  If to OMJ:

  	
   

  	
  OMJ Pharmaceuticals, Inc.

  
	
   

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: 787-892-2095

  
				

 

Notice shall be deemed given on the date of delivery if by personal
delivery by hand, or on the date deposited with the overnight courier if
delivered by overnight courier, or on the fifth day following the date
deposited with the US mail if sent by certified or registered mail.

 

17.8         Binding Effect.
This Agreement shall be binding upon, and shall inure to the benefit of, OMJ
and AMYLIN, and their respective successors and assigns, subject to the
provisions of Section 17.9 below.

 

17.9         No-Assignment.
Neither OMJ nor AMYLIN shall assign this Agreement, in whole or in part,
without the prior written consent of the other party; provided, however, that
AMYLIN may, without OMJ’s consent, assign the Agreement and its rights and
obligations hereunder to an Affiliate or in connection with the transfer or
sale of all or substantially all of its assets or business to which this
Agreement relates, or in the event of its merger or consolidation or change in
control or similar transaction. OMJ shall perform all of its obligations and
duties pursuant to this Agreement, and shall not subcontract any or all

 

* CONFIDENTIAL TREATMENT
REQUEST(ED)

 

11

 

of such obligations, or delegate any or all of such duties hereunder,
without the prior written consent of AMYLIN. The rights and obligations of the
parties under this Agreement shall be binding upon and inure to the benefit of
the successors and permitted assigns of the parties.

 

17.10       Severability.
If any provision of this Agreement shall be invalid or unenforceable to any
extent, the remainder of this Agreement shall not be affected thereby, and
shall remain valid and enforceable to the greatest extent permitted by law.

 

17.11       Governing Law.
The terms and conditions of this Agreement shall be governed by the laws of the
State of California, without regard to its conflicts of laws principles.

 

17.12       Waiver. The
terms of this Agreement may be waived only by a written instrument signed by
the party waiving compliance. The failure of any party at any time to require
performance of any provision hereof shall, in no manner, affect the right at a
later date to enforce the same. No waiver by any party of any condition, or
breach of any provision, term, covenant, representation, or warranty contained
in this Agreement, whether by conduct or otherwise, in any one or more instances,
shall be deemed to be or construed as a further or continuing waiver of any
such condition or the breach of any other provision, term, covenant,
representation or warranty of this Agreement.

 

IN WITNESS
WHEREOF, the parties have caused this Agreement to be signed by their duly
authorized representatives as of the date following their respective name.

 

	
  AMYLIN
  PHARMACEUTICALS, INC.

  	
  OMJ
  PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  
	
  Print Name:

  	
   

  	
   

  	
  Print Name:

  	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
											

 

12

 

EXHIBIT A

 

CONFIDENTIAL

 

 

[***]

 

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

 

Exhibit ‘B’

[***]

 

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

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