EXHIBIT 10.63


 


***Text Omitted and Filed Separately


Confidential Treatment Requested


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


And 240.24b-2


 


CONFIDENTIAL


 


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.


 












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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


 












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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


 












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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.


 












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4.             PURCHASE ORDERS,
INVOICES, DELIVERY.


 


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.


 












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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.


 












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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.


 












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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
[***] 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.


 












*  Confidential Treatment Request(ed)


 


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 of such
obligations, or delegate any or all of such duties hereunder, without the prior
written consent of AMYLIN. The rights


 












*  Confidential Treatment Request(ed)


 


11

















 


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’


 


Pricing


 


[***]


 












*  Confidential Treatment Request(ed)