Exhibit
10.48


 


***Text Omitted and Filed
Separately


Confidential Treatment
Requested


Under 17 C.F.R. §§
200.80(b)(4)


And 240.24b-2


 


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


 


EXENATIDE
MANUFACTURING AGREEMENT


 


THIS
AGREEMENT effective
October 1, 2003, the (“Effective Date”) is made by and between Amylin Pharmaceuticals, Inc., a Delaware
corporation having a principal place of business at 9360 Towne Centre Drive,
Suite 110, San Diego, California 92121 (“AMYLIN”) and Mallinckrodt Inc., a Delaware corporation,
having a principal place of business at 675 McDonnell Blvd., St. Louis,
Missouri 63134 (“MALLINCKRODT”).


 


WHEREAS, AMYLIN requires the manufacture of commercial
supplies of Product (as defined below) on a non-exclusive basis;


 


WHEREAS, MALLINCKRODT desires to manufacture for
AMYLIN commercial supplies of Product on a non-exclusive basis; and


 


NOW, THEREFORE, in consideration of the premises and the
mutual covenants and agreements contained herein, MALLINCKRODT and AMYLIN agree
as follows:


 


1.            Definitions


 


As used in this Agreement, the following
words and phrases shall have the following meanings:


 


1.1           [***]


 


1.2           “Affiliate” means any party that directly (or indirectly through one or
more intermediaries) controls, is controlled by, or is under common control
with a party. For purposes of this definition only, the terms “controls,”
“controlled,” and “control” means (i) the direct or


 


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indirect ability or power to direct or cause the direction of the
management and policies of an entity or otherwise direct the affairs of such
entity, whether through ownership of equity, voting securities, or beneficial
interest, by contract, or otherwise, or (ii) the ownership, directly or
indirectly, of at least 50% of the voting securities (or other comparable
ownership interest for an entity other than a corporation) of a party.


 


1.3           “Agreement”
means this Agreement, together with all exhibits.


 


1.4           “AMYLIN
Indemnitees” shall have the meaning ascribed to it in Paragraph 9.2 hereof.


 


1.5           [***]


 


1.6           “Applicable
Laws” means all United States, European, and any other jurisdiction’s federal,
state, local and other laws, statutes, rules, regulations, ordinances,
(including any amendments thereto), applicable to the import, export,
manufacture and distribution of Product, including, without limitation, the
applicable regulations and guidance of the FDA and all applicable cGMPs, but
only where MALLINCKRODT has authorized reference of its Drug Master File for
Product (it being understood that MALLINCKRODT will authorize reference of its
Drug Master File in the United States and the European Union).


 


1.7           “cGMP”
means “current Good Manufacturing Practices” as defined and in effect from time
to time in regulations and guidelines promulgated by the FDA under the FDCA governing
the manufacture and testing of Product, including without limitation, those
specified in The Rules Governing Medicinal Products in the European Union, the
principles of which are specified in Chapter II of European Commission
Directive 91/356/EEC, and any other laws, regulations, and guidelines
applicable to the manufacture and testing of Product but only where
MALLINCKRODT has authorized reference of its Drug Master File for Product.


 


* Confidential Treatment Request(ed)


 


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1.8           “COA”
means the certificate of analysis furnished by MALLINCKRODT to AMYLIN in
connection with any Lot hereunder indicating the Lot number, specifications,
and all results of analytical and other Product testing required under this
Agreement.


 


1.9           “Collaboration
Partner” means Eli Lilly and Company, with whom AMYLIN has entered into a
collaboration arrangement regarding Product.


 


1.10         “Confidential
Information” shall have the meaning ascribed to it in Paragraph 10.1 hereof.


 


1.11         “Contaminant”
means a substance contained in Product that (i) causes Product to fail to meet
any Product Requirements or (ii) causes Product to be adulterated within the
meaning of the FDCA.


 


1.12         “Contract
Year” means each consecutive calendar year during the term of this Agreement
commencing on October 1 and ending on September 30.


 


1.13         “Contract
Year Forecast” shall have the meaning ascribed to it in Paragraph 2.6 hereof.


 


1.14         “Damage
Claim” shall have the meaning ascribed to it in Paragraph 9.3.


 


1.15         “Damages”
shall have the meaning ascribed to it in Paragraph 9.1.


 


1.16         “Defective
Product” shall have the meaning ascribed to it in Paragraph 6.1 hereof.


 


1.17         “Drug
Master File” means the drug master file (as such term is defined in 21 C.F.R.
Part 314.420) relating to Product manufactured hereunder.


 


1.18         “Effective
Date” means the date first written above.


 


3

















 


1.19         “Exenatide
Injection Drug” means finished formulated injectable drug product containing
Product, for use and administration twice daily (BID).


 


1.20         “Facility”  means 
MALLINCKRODT’s manufacturing, 
testing,  and  storage facility located in St. Louis,
Missouri.


 


1.21         “FDA”
means the United States Food and Drug Administration and any successor entity.


 


1.22         “FDCA”
means the Federal Food Drug and Cosmetics Act, as amended from time to time,
and all regulations promulgated thereunder (or any successor law and all
regulations promulgated thereunder).


 


1.23         “Force
Majeure” shall have the meaning ascribed to it in Article 11 hereof.


 


1.24         “Governmental
Agency” means any federal, state, foreign or local government agency or
authority that has jurisdiction over the manufacture, testing, distribution,
sale or use of Product where MALLINCKRODT has authorized reference to its Drug
Master File for Product.


 


1.25         “Hidden
Defect” means any defect in any Lot that could not reasonably be expected to
have been found by diligent and adequate inspection and testing by AMYLIN, such
as failure to follow CGMPs.


 


1.26         “Indemnified
Party” shall have the meaning ascribed to it in Paragraph 9.3.


 


1.27         “Indemnifying
Party” shall have the meaning ascribed to it in Paragraph 9.3.


 


4

















 


1.28         “Lot”
means that quantity of Product produced from a single homogeneous solution in a
single cycle of lyophilization.


 


1.29         “MALLINCKRODT
Indemnitees” shall have the meaning ascribed to it in Section 9.1 hereof.


 


1.30         “MALLINCKRODT
Technology” means all technical information, whether tangible or intangible and
whether or not patentable, including patents, patent applications and any
method, procedure, process, assay, composition of matter, 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 and
processing of Product, which is conceived, reduced to practice, developed,
owned or licensed by MALLINCKRODT and necessary or useful in the manufacture of
Product.


 


1.31         “NDA”
means AMYLIN’s New Drug Application for Exenatide Injection Drug filed with the
FDA and any other functionally equivalent applications for approval to market
Exenatide Injection Drug outside of the United States.


 


1.32         “Nominal
Lot” means a Lot containing [***] as specified in any applicable Purchase
Order.


 


1.33         “OUS
Sales” means Exenatide Injection Drug commercially sold outside of the United
States.


 


1.34         “Product”
means AMYLIN’s exenatide compound with the structure described in Exhibit A
manufactured in accordance with this Agreement.


 


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1.35         [***]


 


1.36         “Product
Price” shall have the meaning ascribed to it in Paragraph 2.4 hereof.


 


1.37         “Product
Requirements” means all of the requirements set forth, contained, and
referenced in Paragraph 8.1(i)(a - d) of this Agreement.


 


1.38         “Product
Specifications” means the written specifications for Product set forth in Exhibit
B, as amended from time to time pursuant to Paragraph 3.1.


 


1.39         “Product
Validation Lots” means those Lots manufactured under this Agreement for the
purpose of validating the manufacturing and testing activities under this
Agreement to ensure that Product is manufactured in accordance with all Product
Requirements and Applicable Laws for use in commercial production of Exenatide
Injection Drug.


 


1.40         “Quality
Agreement” means the Quality Agreement dated as of the Effective Date between
AMYLIN and MALLINCKRODT 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 Quality
Agreement is incorporated into this Agreement and made a part hereof.  However, it is understood that in the event
of any conflict of inconsistency between the terms of the Quality Agreement and
any other terms or conditions of this Agreement, the latter shall prevail.


 


1.41         “Purchase
Order” shall have the meaning ascribed to it in Paragraph 2.2 hereof.


 


1.42         “Recall
Action” shall have the meaning ascribed to it in Paragraph 4.1 hereof.


 


1.43         “Third
Party” means any person or entity other than MALLINCKRODT or AMYLIN, or their
respective Affiliates.


 


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1.44         “Validation
Batch Production Records” means the documented procedures used to produce
Product Validation Lots that fully comply with Product Specifications and
Validation Requirements.


 


1.45         “Validation
Requirements” means all processes, procedures, yield requirements, in-process
sampling and analysis, and other actions required to be completed or performed
for the manufacture of all Product Validation Lots in accordance with
Applicable Laws, including, without limitation, any re-manufacturing and other
actions required to bring Product into conformance with Governmental Agency
requirements.


 


2.            Purchase and Sale of Product


 


2.1           MALLINCKRODT
understands and agrees that AMYLIN shall have the right to manufacture Product
itself or have Product manufactured by other manufacturers.


 


2.2           MALLINCKRODT
agrees to manufacture and supply to AMYLIN the amounts of Product as ordered by
AMYLIN pursuant to written purchase orders issued hereunder by AMYLIN using a
form of purchase order mutually acceptable to both parties (“Purchase Order”),
specifying the quantity, Nominal Lot quantity, and delivery date. AMYLIN shall
submit each Purchase Order to MALLINCKRODT at least [***] in advance of the
shipment date specified in the Purchase Order and otherwise in accordance with
the requirements hereof. In the event that AMYLIN requests a change to a
Purchase Order, MALLINCKRODT shall use commercially reasonable efforts to
accommodate such request. All Purchase Orders shall be subject to written
acceptance by MALLINCKRODT, which acceptance shall not unreasonably be withheld
or delayed. Notwithstanding any other provision hereof, except with respect to
Product volumes, delivery dates and shipping instructions, no term or condition
of any Purchase Order issued by AMYLIN, any acknowledgement by MALLINCKRODT or
any other document of either party that is in any manner additional to,
different from or varies the terms and conditions hereof shall be deemed to be
of any force or effect.


 


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2.3           Notwithstanding
the provisions of Paragraph 2.2 above, AMYLIN agrees to purchase from
MALLINCKRODT (except to the extent MALLINCKRODT does not accept a Purchase
Order pursuant to Paragraph 2.2 above):


 


[***]


 


Notwithstanding the above, AMYLIN shall not
be required to purchase Product under this Agreement unless MALLINCKRODT
manufactures and delivers all Product Validation Lots meeting all Product
Requirements and Validation Requirements in accordance with this Agreement.


 


2.4           For
each gram of Product supplied hereunder by MALLINCKRODT, AMYLIN will pay to
MALLINCKRODT a price per gram based on the cumulative volume of Product ordered
for supply during any given Contract Year. The per gram price to be billed to
AMYLIN for any Lot or other discrete volume of Product shipped to AMYLIN during
any Contract Year will be at the
applicable price for Product based on the most recent Contract Year Forecast
submitted by AMYLIN prior to the shipment by MALLINCKRODT of any such amount of
Product. Based on the foregoing, AMYLIN will pay to MALLINCKRODT a per gram
price for Product (“Product Price”) in accordance with the following:


 


[***]


 


The Product Prices set forth in the immediately preceding sentence
shall be firm through [***].


 


2.5           If,
with respect to any given Contract Year, it is clear that the annual volume
assumptions on which the Product Prices reflected in any one or more invoices
for Product shipped to AMYLIN during such Contract Year are based are
incorrect, then within thirty (30) days after the end of such Contract Year,
MALLINCKRODT will send corrected invoices to AMYLIN indicating the actual per
gram price for Product shipped during such Contract Year with respect to such
invoices based on the actual volume of Product ordered for delivery during such
Contract Year.  If, on the basis of all
such corrected invoices with respect to a particular Contract Year, when
considered in the aggregate, the amount paid or payable by AMYLIN for Product
shipped during such Contract Year against invoices previously issued by
MALLINCKRODT is in excess of the amount payable by AMYLIN pursuant to all such


 


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corrected invoices then MALLINCKRODT shall, contemporaneous with the
delivery of such corrected invoices and at AMYLIN’s option, give AMYLIN a full
refund of the excess amount or, with respect to any previously issued but as
yet unpaid invoice, issue an appropriate credit equal to the excess amount of
any such invoice. If, on the basis of all such corrected invoices with respect
to a particular Contract Year, when considered in the aggregate, the amount
paid or payable by AMYLIN for Product shipped during such Contract Year against
invoices previously issued by MALLINCKRODT is less than the amount payable by
AMYLIN pursuant to all such corrected invoices, then AMYLIN shall, within
thirty (30) days after the receipt of such  corrected invoices, pay to MALLINCKRODT the
full additional amount due as reflected on such corrected invoices.


 


2.6           Notwithstanding
Paragraph 2.5 set forth immediately above, AMYLIN shall have the right (through
any independent agents or representatives that are reasonably acceptable to
MALLINCKRODT and upon advance written notice to MALLINCKRODT), with respect to
any Contract Year ending not more than [***] prior to the date of notice
requesting an audit, to audit the books and records of MALLINCKRODT to
determine whether or not the amounts reflected on any original invoices
relevant to any such Contract Year or any corrected invoices issued by
MALLINCKRODT to AMYLIN in accordance with Paragraph 2.5 set forth immediately
above are accurate, and in particular (without limitation) whether or not the
Product Costs as reflected in any Annual Adjustment Notice have been reported
and invoiced correctly by MALLINCKRODT, as applicable in any given case.  In the event that, as a consequence of any
such audit or examination, AMYLIN reasonably disagrees with any amounts set
forth on original or corrected invoices issued by MALLINCKRODT, AMYLIN shall
inform MALLINCKRODT in writing and in reasonable detail of the amounts to be
refunded and, unless and to the extent MALLINCKRODT disputes the amounts set
forth by AMYLIN in any such notice, MALLINCKRODT will refund to AMYLIN any such
undisputed amounts within fifteen (15) days of the receipt of any such notice
from AMYLIN. In the event MALLINCKRODT does dispute all or any portion of any
refund claimed by AMYLIN, MALLINCKRODT will so notify AMYLIN within such
fifteen (15) day period and the parties will attempt thereafter to resolve such
dispute amicably and, if they cannot do so, may agree to submit the dispute to
binding arbitration or independently pursue any other remedies available to
them to resolve such dispute. AMYLIN shall bear the expense of such audit;
provided, however, that, if such audit reflects overpayments by AMYLIN, which
are undisputed or confirmed as overpayments pursuant to the dispute resolution
procedure referred to in the preceding sentence, in excess of


 


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[***] of the payments actually due by AMYLIN hereunder for the
applicable period, then MALLINCKRODT shall reimburse AMYLIN for the reasonable
expenses of such audit.


 


2.7           At
the time of shipment by MALLINCKRODT to AMYLIN of any Lot hereunder,
MALLINCKRODT shall submit to AMYLIN an invoice setting forth the total amount of Product being shipped to AMYLIN and
the amount due to MALLINCKRODT pursuant to the volume assumptions made in
accordance with Paragraph 2.4 hereof. Each such invoice shall also contain a
certification that the Product for which AMYLIN is being billed has been
produced fully in conformance with Product Requirements. Any such invoice shall
be payable by AMYLIN within sixty (60) days after AMYLIN’s receipt of such
invoice.


 


2.8           Within
thirty (30) days after the Effective Date, AMYLIN shall submit to MALLINCKRODT
a rolling forecast of Product that AMYLIN in good faith estimates it will order
from MALLINCKRODT for the first Contract Year (as updated on a rolling basis,
the “Contract Year Forecast”). Thereafter, on and as of the first day of [***],
AMYLIN will furnish MALLINCKRODT with an updated Contract Year Forecast
indicating AMYLIN’s good faith estimate of the amounts of Product it expects to
order during the next [***] period. The Contract Year Forecast will be
non-binding and will be used by MALLINCKRODT for production planning, but in
all circumstances AMYLIN shall act in good faith and with reasonable care to
submit forecasts for Product which are as accurate as possible under the
circumstances.


 


3.           Manufacture of Product; Recordkeeping; Regulatory


 


3.1           Each
party shall notify the other in advance of any proposed changes in Product
Specifications, release testing, stability testing, packaging or processes in
manufacturing of Product under this Agreement. No changes in Product
Specifications, release testing, stability testing, packaging or the processes
used to manufacture Product under this Agreement, except changes required by
government or compendial standards, will be made unless AMYLIN and MALLINCKRODT
have agreed to such changes in writing prior to adoption of modified release
testing, stability testing, packaging, Product Specifications or process
changes. Any such changes to the Product Specifications, release testing,
stability testing, packaging or processes of manufacturing Product shall be
handled in accordance with the procedures established in the Quality Agreement,
with costs paid as described below:


 


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(i) 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,
MALLINCKRODT shall, to the extent technologically feasible, accommodate
AMYLIN’s requested changes, provided that AMYLIN shall promptly reimburse
MALLINCKRODT (i.e., upon presentation of an invoice from MALLINCKRODT with
appropriate supporting documentation) for any incremental capital and other
costs reasonably required in connection with such changes (provided
Mallinckrodt has given AMYLIN advance written notice of the nature of such
capital and other costs and provided further that AMYLIN shall have the right
to withdraw any request for a change before implementation has begun if AMYLIN
disagrees with or is unwilling to pay all of such capital and other costs); and
provided further that, any ongoing costs incurred by MALLINCKRODT and
reasonably required in connection with such changes shall be deemed to be [***]
for all purposes hereof;


 


(ii)
in the event MALLINCKRODT 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 or to meet Validation Requirements, all costs
reasonably required in connection with such changes shall be paid as mutually
agreed by both parties; and


 


(iii)
in the event changes are requested by a Governmental Agency or required to
bring the Facility into compliance with Applicable Laws, or additional changes,
activities, or manufacturing is required to bring the process into compliance
with Applicable Laws, cGMP, Product Specifications, or other Product
Requirements, MALLINCKRODT shall, to the extent technologically feasible,
accommodate such changes, and all costs reasonably required in connection with
such changes, activities, or manufacturing shall be deemed to be [***] for all
purposes hereof.


 


3.2           MALLINCKRODT
shall maintain true and accurate books, records, test and laboratory data,
reports and all other information relating to manufacturing under this
Agreement, including without limitation all Validation Production Batch Records
and all information required to be maintained by Applicable Laws.  Such information shall be


 


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maintained in accordance with MALLINCKRODT’s standard operating
procedures for a period of at least five (5) years after the term of this
Agreement, or longer if required under Applicable Laws.


 


3.3           MALLINCKRODT
shall be responsible for obtaining and maintaining any establishment licenses
or permits required by the FDA, Applicable Laws or Governmental Agencies that
pertain to the manufacturing, handling and storage of the Product at the
Facility. MALLINCKRODT hereby grants to AMYLIN and its Collaboration Partner the
right to

reference such establishment files for the purpose of obtaining and maintaining
any regulatory approvals.


 


3.4           MALLINCKRODT
shall advise AMYLIN within three (3) business days after an agent of any
Governmental Agency visits a facility where manufacturing activity with respect
to Product takes place. In such circumstance, MALLINCKRODT shall furnish to
AMYLIN a copy of sections of any report issued by such Governmental Agency that
relate to the Product or MALLINCKRODT’s performance hereunder, if any, within
ten (10) days of receipt of such report. MALLINCKRODT shall provide to AMYLIN
such notice as is reasonably practical under the circumstances of any action by
a Governmental Agency resulting from an inspection of the Facility if such
action may reasonably be anticipated to affect adversely either MALLINCKRODT’s
ability to perform its obligations under this Agreement or AMYLIN’s rights
hereunder.


 


3.5           MALLINCKRODT
shall permit personnel and representatives of AMYLIN and its Collaboration
Partner, upon reasonable advance notice, at reasonable intervals, and for
reasonable duration during regular business hours, to visit the Facility or any
other relevant MALLINCKRODT locations to audit compliance with this Agreement,
including but not limited to the Product Specifications, cGMPs and Applicable
Laws; provided, however, that such audits shall be conducted not more than once
in any twelve (12) month period, except that AMYLIN and its Collaboration
Partner shall be entitled to conduct “for cause” audits at any reasonable time
and upon advance notice (i) following the implementation of measures in
response to Form 483’s or similar reports delivered by Governmental Agencies to
MALLINCKRODT pertaining to the manufacture of Product or (ii) if circumstances
exist that are reasonably likely to adversely


 


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affect the manufacture of Product or AMYLIN’s rights hereunder, and
AMYLIN first discusses the reasons with MALLINCKRODT. All such audits by AMYLIN
and its Collaboration Partner shall be conducted in a manner reasonably
calculated not to interfere with MALLINCKRODT’s business activities and in
compliance with MALLINCKRODT’s security and safety policies and procedures. All
information obtained by AMYLIN or its Collaboration Partner in any such review
(including, without limitation, the findings and results related thereto but
excluding all Confidential Information of AMYLIN and its Collaboration
Partner), shall be deemed MALLINCKRODT’s Confidential Information, provided,
however. AMYLIN and its Collaboration Partner shall not be precluded from
disclosing such MALLINCKRODT Confidential Information to Governmental Agencies
to the extent and only to the extent required by law or for their regulatory
filings. MALLINCKRODT will have the responsibility to audit its permitted
subcontractors and suppliers at reasonable intervals for compliance with the
Product Requirements, CGMPs and Applicable Laws. AMYLIN shall have the right to
confirm audits of subcontractors and suppliers of MALLINCKRODT for any Products
manufactured under this Agreement during its audits of MALLINCKRODT’s
facilities.


 


3.6           MALLINCKRODT
agrees to use its commercially reasonable efforts to assist AMYLIN and its
Collaboration Partner in obtaining regulatory approvals from all Governmental
Agencies with respect to the Product, including FDA approval of the NDA,
subject to reimbursement by AMYLIN of all reasonable costs incurred in
connection therewith. MALLINCKRODT specifically agrees to cooperate with any inspection
by the FDA or other Governmental Agency, including but not limited to any
pre-approval inspection in connection with the NDA. MALLINCKRODT shall, on a
timely basis, provide AMYLIN and its Collaboration Partner with documentation,
data, and such other information relating to Product that is reasonably
necessary for and relevant to AMYLIN’s or its Collaboration Partner’s efforts
to obtain, maintain, and support regulatory approvals relating to Product.
MALLINCKRODT shall also provide, upon request by AMYLIN or its Collaboration
Partner, non-proprietary and nonconfidential information concerning its
production processes and quality control procedures with respect to Product.
Without limiting the generality of the foregoing, MALLINCKRODT agrees to establish
and maintain a Drug Master File (including, upon six (6) months advance notice
from AMYLIN a foreign equivalent of a Drug Master File in those countries
reasonably requested by AMYLIN) for the Product in accordance with the
requirements of the FDA and any


 


13

















 


other applicable Governmental Agency, and to provide AMYLIN and its
Collaboration Partner with letters of authorization to, and rights to
reference, the Drug Master File and any foreign equivalents thereof. Further,
AMYLIN and its Collaboration Partner shall have the right to review the open
Drug Master File, and all stability data, release testing results, impurity
profiles, facility and equipment data, validation data and all information
related to the validation of analytical method with respect to the Product.
MALLINCKRODT shall update the Drug Master File and any foreign equivalents
thereof in a timely manner to support any NDA filing. All information regarding
all aspects of manufacture of Product necessary for and/or related to AMYLIN’s
and/or its Collaboration Partner’s regulatory filings shall, at MALLINCKRODT’s
option, either be (i) maintained by MALLINCKRODT in a Drug Master File or (ii)
provided to AMYLIN or its Collaboration Partner for inclusion in their
respective regulatory filings. During the course of a Governmental Agency’s
review of the NDA, MALLINCKRODT shall inform AMYLIN and its Collaboration
Partner of any comments (including indication of deficiencies) to the Drug
Master File or any foreign equivalents thereof from any such Governmental
Agencies, and MALLINCKRODT shall consult with AMYLIN and, in the case of
Governmental Agencies outside of the United States, its Collaboration Partner,
in drafting responses to any such comments.


 


3.7           AMYLIN
and MALLINCKRODT shall promptly (and in any event within two (2) business days)
advise the other of any safety or toxicity problem of which such party becomes
aware regarding Product.


 


3.8           The
obligations of MALLINCKRODT and AMYLIN set forth in this Section 3 are intended
to comply with the Applicable Laws of each country where the Product is
distributed, but only where MALLINCKRODT has authorized reference of its Drug
Master File for Product. The requirements of this Section 3 shall therefore be
construed and interpreted to comply with all such Applicable Laws, but only
where MALLINCKRODT has authorized reference of its Drug Master File for
Product.


 


3.9           Any
and all release testing methods, Product Specifications, and stability data
provided by AMYLIN or generated from information or data provided by AMYLIN
shall be the Confidential Information of AMYLIN.


 


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4.             Recalls and Similar Actions


 


4.1           If
there is a recall, withdrawal or field correction with respect to, or any
governmental seizure of, Exenatide Injection Drug (“Recall Action”), which
Recall Action is due in part to (i) the failure of Product manufactured by
MALLINCKRODT to meet any of the Product Requirements, or (ii) the alleged negligent
or intentional wrongful act or omission of MALLINCKRODT in connection with the
manufacture of Product, then AMYLIN or, in the case of  OUS Sales subject to a Recall Action,
Collaboration Partner, will notify MALLINCKRODT promptly of the details regarding
such Recall Action, including providing copies of all relevant documentation
concerning such Recall Action. 
MALLINCKRODT will assist AMYLIN and its Collaboration Partner in
investigating any such Recall Action, if AMYLIN or its Collaboration Partner so
requests, and all regulatory contacts that are made and all activities
concerning such Recall Action will be initiated and coordinated by AMYLIN or,
in the case of OUS Sales subject to a Recall Action, Collaboration Partner with
MALLINCKRODT’s involvement and assistance, as reasonably requested by AMYLIN or
its Collaboration Partner.


 


4.2           If
any Recall Action occurs which is due in part to (i) the failure of Product
manufactured by MALLINCKRODT to meet any of the Product Specifications or
Product Requirements, (ii) the failure of MALLINCKRODT to comply with cGMP
requirements and the requirements of any other Applicable Laws, rules or
regulations or (iii) the negligent or intentional wrongful act or omission of
MALLINCKRODT in connection with the manufacture of Product, then MALLINCKRODT
shall, to the extent and only to the extent of its relative responsibility,
bear the cost and expense of any such Recall Action. Therefore, if both
MALLINCKRODT and AMYLIN contribute to the cause of such a Recall Action, the cost
and expense thereof will be shared in proportion to each party’s contribution
to the problem. 


 


5.            Shipment and Delivery


 


On or before the delivery date of each
shipment of Product MALLINCKRODT shall deliver to AMYLIN the COA for each Lot
of Product being shipped.  Delivery of
the COA by


 


15

















 


MALLINCKRODT to AMYLIN shall mean MALLINCKRODT has tested and analyzed
such Lot of Product to ensure compliance with Product Specifications as defined
in Exhibit B and other Product Requirements and, if applicable,
Validation Requirements. MALLINCKRODT shall be primarily responsible for all
such initial testing of Product; provided, however, AMYLIN shall have the right
to subsequent inspection and final acceptance or rejection of such Product
pursuant to the terms of this Agreement. MALLINCKRODT shall deliver each Lot of
Product to the location specified by AMYLIN in its Purchase Order for such Lot.
Each Lot of Product will be packed by MALLINCKRODT in accordance with AMYLIN’s
specific instructions and standard operating procedure (currently AMYLIN
SOP-QUM-146), a copy of which shall be provided to MALLINCKRODT. Product shall
be delivered F.C.A. (Incoterms 2000) MALLINCKRODT’s Facility. Freight shall be
pre-paid to the destination specified by AMYLIN in its Purchase Order.
MALLINCKRODT will be responsible for arrangements regarding the shipping of
Product to designated destinations but AMYLIN shall reimburse MALLINCKRODT for
all applicable shipping charges.


 


6.            Acceptance/Rejection of Product


 


6.1           Not
later than [***] after receipt of each Lot of Product (other than Product
Validation Lots), if AMYLIN believes that any such Lot does not comply with all
of the Product Requirements (any Product failing to comply with the foregoing a
“Defective Product”), AMYLIN shall notify MALLINCKRODT in writing of AMYLIN’s
rejection of such Lot and the specific reasons therefor.  If MALLINCKRODT does not agree that any such
rejected Lot is Defective Product, both MALLINCKRODT and AMYLIN shall submit a
sample of such Lot and other relevant information for analysis by an
independent expert mutually satisfactory to the parties, and the decision of
this independent expert as to whether such Lot of Product is Defective Product
shall be final and binding upon the parties. The fees of such expert shall be
borne by AMYLIN if such Lot is determined by such expert not to be Defective
Product, or by MALLINCKRODT if such Lot is determined to be Defective Product.


 


6.2           If a
Lot of Product (other than a Product Validation Lot) is rejected by AMYLIN as
Defective Product and either MALLINCKRODT agrees to the rejection or the
independent


 


*
Confidential Treatment Request(ed)


 


16

















 


expert determines that such Lot constitutes Defective Product,
MALLINCKRODT shall, upon request from AMYLIN and at AMYLIN’s option, (i)
promptly replace such Lot of Product at no additional expense to AMYLIN, (ii)
promptly remedy the deficiency at MALLINCKRODT’s expense or (iii) immediately
refund any amounts paid by AMYLIN for such rejected Lot. It is agreed that the
remedies set forth in this Paragraph 6.2 are AMYLIN’s sole remedies in the
event of any rejection by AMYLIN of Defective Product (but are subject to
AMYLIN’s rights set forth in Paragraph 6.3). If AMYLIN has properly rejected
Product and the deficiency causing it to be Defective Product cannot be
remedied, AMYLIN will, at MALLINCKRODT’s option, either return such Defective
Product to MALLINCKRODT or destroy or dispose of it in the least expensive and
most environmentally sound manner and, in any event, MALLINCKRODT shall be
responsible for the expense of any such return, destruction or disposal.
Failure of AMYLIN to notify MALLINCKRODT in writing of rejection of a Lot as set
forth herein within [***] of receipt of such Lot shall constitute acceptance of
such Product Lot and such Lot cannot subsequently be rejected except for a
Hidden Defect in accordance with Paragraph 6.3 set forth immediately below.


 


6.3           If,
after AMYLIN’s acceptance of a Lot (including without limitation any Product
Validation Lot), AMYLIN discovers in such Lot a Hidden Defect such as a
Contaminant at any time after acceptance, AMYLIN shall notify MALLINCKRODT
within [***] of such discovery of the Hidden Defect, and AMYLIN has the right
to reject the Lot under the procedures regarding rejection set forth
immediately above in Paragraph 6.2 and, in the case of a Product Validation
Lot, in Paragraph 6.4.


 


6.4           With respect to all Product Validation Lots
manufactured under this Agreement, AMYLIN shall have the right to reject any
such Product Validation Lot, if such Lot, upon delivery to AMYLIN, does not
comply with all Validation Requirements or Product Requirements.  AMYLIN will have the right to reject any such
Product Validation Lot by providing written notice to MALLINCKRODT not later
than the later of either (i) [***] after receipt of such Lot, or (ii) [***]
after the date when AMYLIN discovers or receives notice that the Lot does not
meet all Product Requirements or all Validation Requirements (e.g.,
Governmental Agency deems that Lot does not satisfy all Validation Requirements
and requires the re-manufacture of the Lot). If, after AMYLIN’s acceptance of
any Product Validation Lot, AMYLIN rejects any of the other Product Validation
Lots, then AMYLIN will have the right to reject any or all Product Validation
Lots that were previously


 


*
Confidential Treatment Request(ed)


 


17

















 


accepted as not being in compliance with the requirement in Paragraph
8.1(vi) that all Product Validation Lots meet all Validation Requirements upon
delivery to AMYLIN. For all Product Validation Lots rejected by AMYLIN,
MALLINCKRODT shall, upon request from AMYLIN and at AMYLIN’s option, (x)
promptly replace such Lot at no additional expense to AMYLIN, (y) promptly
remedy the deficiency at MALLINCKRODT’s expense, or (z) immediately refund any
amounts paid by AMYLIN for such rejected Lot. It is agreed that the remedies
set forth in the immediately preceding sentence are AMYLIN’s sole remedies in
the event of any rejection by AMYLIN of Product Validation Lot(s). Disposal of
rejected Product Validation Lots and all work associated with completing all
Validation Requirements to ensure that Product Validation Lots meet all
Validation Requirements (including without limitation re-manufacture of Product
Validation Lots to bring such Lots into conformance with Governmental Agency
requirements) shall be at the sole cost and expense of MALLINCKRODT.


 


7.           Term and Termination


 


7.1           This
Agreement shall commence on the Effective Date, and unless earlier terminated
as stated below, will continue for a period of five (5) Contract Years
(“Initial Term), automatically renewing on an annual basis thereafter for
additional single Contract Year terms.


 


7.2           This
Agreement may be terminated as follows:


 


(i)         either party may terminate this Agreement by
written notice to the other party effective immediately (a) upon the
institution by such other party of voluntary proceedings in bankruptcy or
insolvency, or (b) sixty (60) days after the filing of an involuntary petition
under any bankruptcy or insolvency law (unless such petition is dismissed or
set aside within such 60-day period) against the other party, or (c) sixty (60)
days after the appointment of a receiver or trustee for the assets of business
of the other


 


18

















 


party
(unless such appointment is dismissed or set aside within such 60-day period);


 


(ii)        if either party shall have committed a
material breach and such material breach remains uncured and continues for a
period of thirty (30) days following receipt of notice thereof by the
non-breaching party, the non-breaching party may terminate this Agreement upon
additional written notice given on or after the expiration of such thirty
(30)-day period; or


 


(iii)       AMYLIN may terminate this Agreement at any
time by giving MALLINCKRODT at least thirty (30) days written notice in each of
the following situations:


(a)   upon notice
by the FDA or other applicable Government Agency that MALLINCKRODT has failed
successfully to complete its Pre-Approval Inspection or equivalent non-United
States inspection by failing adequately to respond to any FDA or other
applicable Government Agency findings within thirty (30) days of inspection,
and therefore is not an approved commercial supplier of Product,


(b)   upon
notification by the FDA or other applicable Government Agency that it will not
approve any NDA filed in the United States relative to Product,


(c)   upon
withdrawal by AMYLIN of any Investigational New Drug Application containing
Product,


(d)   if AMYLIN
reasonably determines that discontinuation of all development and
commercialization of Product is in the best interests of AMYLIN, and AMYLIN
takes reasonable steps in order to discontinue all development and
commercialization efforts by AMYLIN, its agents and licensees, or


(e)   in the event
of a Force Majeure event preventing or impairing MALLINCKRODT’s performance
hereunder which event has existed for at least ninety (90) continuous days;


 


19

















 


(iv)       AMYLIN may terminate this Agreement, in its
sole discretion, at any time following the Initial Term, without cause, by
providing at least ninety (90) days prior written notice to MALLINCKRODT; or


 


(v)        either party may terminate this Agreement,
effective as of the end of the Initial Term or any Contract Year renewal term
following the Initial Term, by providing written notice to the other party hereunder
at least one (1) year prior to the effective date of such termination, which
notice may be sent at any time on or after the fourth (4th) Contract
Year of this Agreement.


 


The parties acknowledge that the
Collaboration Partner shall have the right, but not the obligation, to cure a
breach of any material provision of this Agreement by Amylin if Amylin does not
do so.


 


7.3          In the event of a termination by AMYLIN pursuant to subclauses (b), (c)
and (d) of subparagraph (iii), subparagraph (iv) or subparagraph (v) of
Paragraph 7.2 above, AMYLIN shall compensate MALLINCKRODT for (i) all inventory
of finished Product then held by MALLINCKRODT at [***], (ii) Mallinckrodt’s
[***] for all then existing work-in-process with respect to Product and (iii)
all [***] of MALLINCKRODT for existing raw materials inventory to be used in
any manner in connection with manufacture hereunder, in each case as the
foregoing exist on and as of the effective date of such termination, and in
each case to the extent related to purchase orders received by MALLINCKRODT
through the effective date of termination.


 


7.4          Termination or expiration of this Agreement through any means or for
any reason shall not relieve the parties of any obligation accruing prior
thereto and shall be without prejudice to the rights and remedies of any party
with respect to any antecedent breach of any of the provisions of this
Agreement. The representations and warranties of the parties, which by their
terms have effect after termination or expiration hereof, and the parties’
confidentiality and indemnification obligations, as well as this Paragraph 7.4,
shall survive termination or expiration of this Agreement.


 


*
Confidential Treatment Request(ed)


 


20

















 


8.             Warranties


 


8.1           MALLINCKRODT
represents, warrants, and covenants that


 


(i)            upon
delivery to AMYLIN, all Product shall:


 


a)            meet all Product Specifications at the time
of delivery and shall have been manufactured and packaged at the Facility in
accordance with the Product Specifications,


b)           be manufactured in accordance with all applicable requirements of the
FDCA (including but not limited to cGMPs) and all other Applicable Laws, and be
free from any Contaminants,


c)            not be adulterated within the meaning of the
FDCA or any Applicable Laws in which the definition of adulteration is
substantially the same as in the FDCA (as such Applicable Laws 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, be introduced into interstate
commerce,


d)            be manufactured using starting materials that
are certified to be free of any TSE/BSE (transmittable spongiform
encephalitis/bovine spongiform encephalitis) and originate from sources that
are not of human, bovine, or ruminant animal tissue, and


e)            be in undamaged containers;


 


(ii)           each
COA shall accurately and completely reflect the results of the tests conducted
on the Lot of Product to which it relates;


 


(iii)          the
records maintained by MALLINCKRODT will reflect in all material respects the
processes and procedures followed by it in manufacturing Product;


 


(iv)          the
use of the MALLINCKRODT Technology in connection herewith will not infringe any
third party patent, copyright, trademark or other known intellectual property
rights of any Third Party as such rights currently exist;


 


21

















 


(v)           all
Product delivered shall be received by AMYLIN no later than either (a) [***]
after the date of its actual manufacture if the applicable use period of such
Product is [***], or (b) [***] after the date of its actual manufacture if the
applicable use period of such Product is [***]; and (vi) in addition to
complying with the terms of 8.1 (i)(a) through (e) above, all Product
Validation Lots shall meet all Validation Requirements upon delivery to AMYLIN.


 


8.2           EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, MALLINCKRODT MAKES NO
OTHER WARRANTIES, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCT OR ITS
PERFORMANCE HEREUNDER, AND ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY MALLINCKRODT.


 


8.3           EXCEPT FOR ANY DAMAGES AWARDED OR PAID TO A THIRD PARTY FOR WHICH A
MALLINCKRODT INDEMNITEE (AS DEFINED BELOW) IS SEEKING INDEMNIFICATION  PURSUANT TO THE  PROVISIONS  OF  CLAUSE 
(iv) of PARAGRAPH 9.1, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO ANY
PARTY OR PERSON FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR
PUNITIVE DAMAGES OF ANY NATURE WHATSOEVER, 
INCLUDING WITHOUT LIMITATION LOSS OF PROFITS OR BUSINESS INTERRUPTION,
EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN IF, UNDER ANY
PARTICULAR SET OF CIRCUMSTANCES, SUCH DAMAGES ARE REASONABLY FORESEEABLE. THIS
PARAGRAPH SHALL NOT BE CONSTRUED TO LIMIT A PARTY’S RIGHT TO SEEK ANY AVAILABLE
REMEDIES FOR BREACH OF CONFIDENTIALITY AND NON-USE OBLIGATIONS.


 


9.           Indemnification


 


9.1           AMYLIN
shall defend, indemnify, and hold MALLINCKRODT and its Affiliates and its and
their directors, officers, shareholders, insurers, employees, and agents


 


*
Confidential Treatment Request(ed)


 


22

















 


(“MALLINCKRODT Indemnitees”) harmless against any liability, judgment,
demand, action, suit, loss, damage, cost or other expense, including reasonable
attorney’s fees (“Damages”), resulting from any Third Party claims made or
proceedings brought against a MALLINCKRODT Indemnitee to the extent that such
liability arises from (i) AMYLIN’s negligence or willful act or omission
regarding Product supplied under this Agreement, (ii) AMYLIN’s breach of any
warranty or provision of this Agreement, (iii) AMYLIN’s violation of any
Applicable Laws, rules or regulations and (iv) the manufacture (other than the
manufacture of Product by MALLINCKRODT under this Agreement), sale, promotion,
distribution or use of any product containing Product supplied under this
Agreement by or on behalf of AMYLIN, including all product liability claims or
proceedings; provided, however, that AMYLIN shall have no liability under this
Paragraph 9.1 with respect to any Damages to the extent arising from matters as
to which MALLINCKRODT has the obligation to indemnify pursuant to Paragraph 9.2
set forth immediately below.


 


9.2           MALLINCKRODT
shall defend, indemnify, and hold AMYLIN and its Collaboration Partner and
their respective Affiliates and its and their directors, officers,
shareholders, insurers, employees, and agents (“AMYLIN Indemnitees”) harmless
against any Damages resulting from any Third Party claims made or proceedings
brought against an AMYLIN Indemnitee to the extent that such liability arises
from (i) MALLINCKRODT’s negligence or willful act or omission in the
manufacture, storage or delivery of Product, (ii) MALLINCKRODT’s breach  of any warranty or provision of this  Agreement, 
or  (iii) MALLINCKRODT’s
violation of any Applicable Laws, rules or regulation.


 


9.3           Procedures.


 


9.3.1      A
party (the “Indemnified Party”) that intends to claim indemnification under
this Section shall promptly notify the other party (the “Indemnifying Party”)
in writing of any claim of a Third Party which may reasonably be expected to
result in a claim for Damages (“Damage Claim”) by the Indemnified Party. Notice
by the Indemnified Party to the Indemnifying Party shall include a copy of the
Third Party claim. An Indemnifying Party shall have the right to direct the
defense, compromise or settlement of


 


23

















 


such claim with counsel selected by it,
provided the Indemnifying Party gives written notice to the Indemnified Party
of its election to do so within twenty (20) days after receipt of notice in
accordance with the preceding sentence. If the Indemnifying Party fails to so
notify the Indemnified Party of its election to defend any such Third Party
claim, the Indemnified Party will (upon further notice to the Indemnifying
Party) have the right to undertake the defense, compromise or settlement of
such claim on behalf of and for the account and expense of the Indemnifying
Party, subject to the right of the Indemnifying Party to assume the defense of
such claim at any time prior to settlement, compromise or final determination
thereof if and only if such assumption would not prejudice the defense of such
claim or the rights of the Indemnified Party.


 


9.3.2      In the
event an Indemnifying Party has assumed the defense of any such claim, the
Indemnified Party shall nonetheless have the right to select its own counsel
and participate in the defense of such claim at and for its own expense and
account. Where the Indemnifying Party has assumed defense of any Damage Claim,
the Indemnified Party and its counsel, if retained, shall consult and cooperate
with counsel for the Indemnifying Party in defending against any such Third
Party claim.  Such cooperation shall
include, without limitation, providing documents, making employees available
for interviews, depositions and testimony and consultation on technical
matters.


 


9.3.3      An
Indemnifying Party shall not under any circumstances, without the written
consent of the Indemnified Party, settle or compromise any claim or consent to
the entry of any judgment which might in any material way prejudice or
adversely affect the Indemnified Party or its continued business activities and
which does not include as an unconditional term thereof the giving by the
claimant or the plaintiff to the Indemnified Party a release from all liability
in respect of such claim, in form and substance reasonably satisfactory to the
Indemnified Party.


 


9.3.4      Notwithstanding
anything to the contrary contained herein, with respect to a Third Party claim
that can be settled by the payment of money, if a Third Party claim is made
which the Third Party is unequivocally willing to settle but an Indemnified
Party


 


24

















 


elects
not to settle, then the Indemnifying Party shall not be liable hereunder, with
respect to any Damage Claim arising from such Third Party claim, for more than
the amount which such Third Party at any time unequivocally agrees in writing
to accept in payment or compromise of the claim plus any related costs and
expenses incurred by the Indemnified Party as of the date of such offer of
settlement.


 


9.3.5      All Damage
Claims for indemnification hereunder shall be made in a written notice setting
forth, with particularity, the nature of the claim for which indemnification is
sought. The parties agree that no Damage Claim for indemnification shall be
made hereunder unless the party requesting indemnification shall have a good
faith belief that it is entitled to indemnification hereunder.


 


10.          Confidential Information


 


10.1         Any
and all knowledge, know-how, practices, specifications, methods, release
testing methods, stability data, processes or other confidential or proprietary
information of MALLINCKRODT, or AMYLIN and its Collaboration Partner
(hereinafter referred to as “Confidential Information”) disclosed orally, by
means of inspection or submitted in writing or in other tangible form by the
disclosing party to the receiving party shall be deemed to be confidential and
shall be received and maintained in strict confidence and shall not be
disclosed to any Third Party without the prior written consent of the disclosing
party, which consent shall not unreasonably be withheld or delayed. The
recipient shall not use said Confidential Information for any purpose other
than to facilitate the recipient’s performance under this Agreement, and the
disclosing party’s Confidential Information shall at all times be and remain
the sole and exclusive property of the disclosing party. The recipient may
disclose Confidential Information to employees and/or consultants requiring
access thereto for the purposes of this Agreement, and in the case of AMYLIN,
to its Collaboration Partner; provided, however, that prior to making any such
disclosures, Collaboration Partner and each such employee and consultant shall
be apprised of the duty and obligation to maintain Confidential Information in
confidence and not to use such information for any purpose other than in
accordance with the terms and conditions of this Agreement.  In any event, the recipient of any
Confidential


 


25

















 


Information shall be fully responsible for the improper disclosure or
use of the Confidential Information by anyone to whom such Confidential
Information is disclosed by the recipient. Each party shall take all steps
reasonably necessary to assure that the Confidential Information received will
be maintained in confidence by such party, including taking such steps as it
normally takes to prevent the disclosure of its own proprietary and
confidential information of like character.


 


10.2        The nondisclosure and non-use obligations of
Paragraph 10.1 above shall not apply to Confidential Information which:


 


(i)            is publicly known prior to disclosure or,
subsequent to disclosure hereunder, has become publicly known and the recipient
can demonstrate became publicly known without fault on the part of the
receiving party,


 


(ii)           the recipient can demonstrate was otherwise
known by the receiving party prior to disclosure hereunder or was generated for
the receiving party by persons who have not had access to or knowledge of the
Confidential Information, or


 


(iii)          the recipient party can demonstrate was
received by the receiving party at any time from a source other than the
disclosing party or its agents, lawfully having possession of such information
and under no obligation of confidentiality with respect to such information.


 


Notwithstanding Paragraph 10.1, the recipient party may disclose
Confidential Information of the disclosing party, without violating the
obligations of this Agreement, to the extent the disclosure is required by a valid
order of a court or other governmental body having jurisdiction, by any
Governmental Agency or by Applicable Laws; provided that, the recipient party
gives reasonable prior written notice to the disclosing party of such required
disclosure and makes a reasonable effort to obtain, or to assist the disclosing
party in obtaining, a protective order preventing or limiting the disclosure
and/or requiring that the Confidential Information so disclosed be used only
for the purposes for which the law or regulation requires, or for which the
order was issued.


 


26

















 


10.3         The
obligations of this Article 10 shall be in effect during the term of this
Agreement and for a period of five (5) years from the expiration or any earlier
termination of this Agreement.


 


10.4        The parties hereto acknowledge and agree that any breach by either of
them of the obligations set forth in this Article 10 may cause the other party
irreparable damage of a type that cannot be adequately compensated by monetary
damages and, therefore, in the event of such breach, the non-defaulting party
shall have the right to seek an injunction or other appropriate equitable
relief (without the requirement of posting a bond or any other financial
assurance), in addition to any other remedies at law the non-defaulting party
may have.


 


11.         Force Majeure


 


If the performance by either party of any
obligation under this Agreement is prevented or impaired by an event of “Force
Majeure”, such party shall be excused from performance so long as such event
continues to prevent or impair performance, provided the party claiming such
excuse shall have promptly notified the other party of the existence, nature,
expected duration and other significant details of such event and shall at all
times use diligent and commercially reasonable efforts to resume performance.
If either party anticipates that a Force Majeure event may occur, that party
shall notify the other immediately and explain the nature, significant details
and expected duration thereof. The party affected by an event of Force Majeure
will advise the other from time to time as to its progress in remedying the
situation and as to the time when the affected party expects to resume its
performance of its obligations. Additionally, the party affected by an event of
Force Majeure shall notify the other party of the expiration of any event of
Force Majeure as soon as the affected party knows the date thereof. For
purposes hereof, an event of “Force Majeure” shall mean an event beyond the
reasonable control of a party including, but not limited to, fire, flood,
sabotage, shipwreck, embargo, acts of terrorism, explosion, accident, riot, act
of governmental authority, acts of God, acts of war, and unusually severe
weather; provided that, MALLINCKRODT’s capacity constraints shall not be
considered an event of Force Majeure hereunder. Notwithstanding the occurrence
of a Force Majeure event,


 


27

















 


if MALLINCKRODT shall be unable to supply during any Contract Year any
Product ordered by AMYLIN that is not in excess of those estimated amounts
stated in the applicable Contract Year Forecasts, AMYLIN and MALLINCKRODT will
consult with each other to determine what measures may reasonably be taken to
solve the supply problem. Notwithstanding the foregoing, if MALLINCKRODT
undergoes a Force Majeure event that results in MALLINCKRODT failing to
manufacture Product pursuant to any Purchase Order under this Agreement, the
volume of any Product purchased by AMYLIN from alternate Third-Party suppliers
during the duration of the Force Majeure event shall be applied towards the
minimum purchase amounts in Paragraph 2.3 above for the applicable Contract
Year. Further notwithstanding the foregoing, a party’s failure to pay to the
other party any amounts payable hereunder as and when due shall in no event be
excused by the occurrence of an event of Force Majeure.


 


12.          Insurance. Upon AMYLIN’s request, MALLINCKRODT shall
provide to AMYLIN written evidence reasonably satisfactory to AMYLIN of the
sufficiency of MALLINCKRODT’s insurance program.


 


13.           Notices


 


All notices, consents, approvals or other
notifications required to be sent by one party to the other party hereunder
shall be in writing and shall be deemed served upon the other party if
delivered by hand or sent by United States registered or certified mail,
postage prepaid, with return receipt requested, or by facsimile, air courier or
telex, addressed to such other party at the address set out below, or the last
address of such party as shall have been communicated to the other party. If a
party changes its address, written notice shall be given promptly to the other
party of the new address. Notice shall be deemed given on the day it is sent
(in the case of delivery by method other than hand delivery) or the date of
delivery (in the case of delivery by hand) in accordance with the provisions of
this paragraph. The addresses for notices are as follows:


 


28

















 


	
  If
  to AMYLIN:

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
  9360 Towne Centre Drive,
  Suite 110

  
	
   

  	
  San Diego, California
  92121

  
	
   

  	
  Attn: John Grove, Senior
  Director of Manufacturing

  
	
   

  	
  Fax No.: (858) 558-0290

  
	
   

  	
   

  
	
  With a copy to:

  	
  Amylin Pharmaceuticals,
  Inc. 9360

  
	
   

  	
  Towne Centre Drive, Suite
  110

  
	
   

  	
  San Diego, California
  92121 Attn:

  
	
   

  	
  Lloyd A. Rowland, Esq.,

  
	
   

  	
  Vice President and General
  Counsel

  
	
   

  	
  Fax No.: (858) 552-1936

  
	
   

  	
   

  
	
  If to MALLINCKRODT:

  	
  Mallinckrodt Inc.

  
	
   

  	
  P.O. Box 5840 675

  
	
   

  	
  McDonnell Blvd. St. Louis,

  
	
   

  	
  Missouri 63134 Attn:

  
	
   

  	
  Michael J. Collins Fax
  No.:

  
	
   

  	
  314-654-6020

  
	
   

  	
   

  
	
  With a copy to:

  	
  Mallinckrodt Inc.

  
	
   

  	
  P.O. Box 5840 675

  
	
   

  	
  McDonnell Blvd. St. Louis,

  
	
   

  	
  MO 63134

  
	
   

  	
  Attn: C. Stephen Kriegh

  
	
   

  	
  Fax No.: 314-654-7181

  



 


29

















 


14.          Binding Effect


 


This Agreement shall be binding upon and
shall inure to the benefit of the parties hereto and their respective permitted
assigns and successors in interest. Collaboration Partner is an intended Third
Party beneficiary of the provisions and only those provisions of this Agreement
specifically referring to Collaboration Partner.


 


15.          Independent Contractor


 


In all matters relating to this Agreement,
MALLINCKRODT shall be acting as an independent contractor and not as an
employee of AMYLIN.


 


16.          Assignment


 


Neither party shall assign this Agreement or
any part thereof without the prior written consent of the other party;
provided, however, that either party, without such consent, may assign or
transfer the same: (i) in connection with the transfer or sale of substantially
its entire business to which this Agreement pertains or in the event of its
merger or consolidation with another company, or (ii) to an Affiliate, provided
that such party guarantees the performance of the Affiliate to which the
Agreement is assigned. Any permitted assignee shall assume all obligations of
its assignor under this Agreement. No assignment shall relieve any party of
responsibility for the performance of any accrued obligation which such party
then has hereunder. MALLINCKRODT shall not subcontract the manufacture of
Product or any other activity under this Agreement without the prior express
written consent of AMYLIN, which consent shall not unreasonably be withheld or
delayed.


 


30

















 


17.          Entire Agreement


 


This Agreement sets forth the entire
agreement between AMYLIN and MALLINCKRODT with respect to its subject matter,
and fully supersedes any and all prior and contemporaneous agreements or
understandings pertaining to the subject matter hereof.


 


18.          Severability


 


A determination that any portion of this
Agreement is unenforceable or invalid shall not affect the enforceability or
validity of any of the remaining portions hereof or of this Agreement as a
whole, unless such unenforceability or invalidity goes to the essence of the
agreement between the parties, in which case this Agreement shall be and become
null and void as and from the date of such unenforceability or invalidity. In
the event that any part of any of the covenants, sections or provisions herein
may be determined by a court of law or equity to be overly broad or against
applicable precedent or public policy, thereby making such covenants, sections
or provisions invalid or unenforceable, and such determination does not go to
the essence of this Agreement for either one of the parties hereto, then the
parties shall attempt to reach agreement with respect to a valid and
enforceable substitute for the deleted provisions, which shall be as close in
its intent and effect as possible to the deleted portions.


 


19.          Waiver - Modification of
Agreement


 


No waiver or modification of any of the terms
of this Agreement shall be valid unless in writing and signed by authorized
representatives of both parties hereto. No course of dealing or usage of trade
shall be applicable unless expressly incorporated in this Agreement. Failure by
either party on any occasion to enforce any rights under this Agreement shall
not be construed as a waiver of such rights nor shall a waiver by either party
in one or more instances be construed as constituting a continuing waiver or as
a waiver in other instances.


 


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20.          Publicity


 


In the absence of specific agreement between
the parties, neither party shall originate any publicity, news release or other
public announcement, written or oral, whether to the public press, to
stockholders or otherwise relating to this Agreement or to performance
hereunder.


 


21.          Exhibits


 


All Exhibits referenced herein are hereby
made a part of this Agreement.


 


22.          Governing Law


 


This Agreement shall be construed and
enforced in accordance with the laws of the State of New York, without
reference to its conflict of laws principles that might apply the law of
another jurisdiction.


 


23.          Counterparts


 


This Agreement may be executed in any number
of separate counterparts, each of which shall be deemed to be an original, but
which together shall constitute one and the same instrument.


 


24.          Headings


 


The parties agree that the section and
article headings are inserted only for ease of reference, shall not be
construed as part of this Agreement, and shall have no effect upon the
construction or interpretation of any part hereof.


 


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IN WITNESS
WHEREOF, the parties
have caused this Agreement to be executed by their duly authorized
representatives. 


 


	
  MALLINCKRODT INC.

  	
  AMYLIN PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  	 

										



 


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EXHIBIT A


 


STRUCTURE
OF EXENATIDE COMPOUND


 


[***]


 


* Confidential Treatment Request(ed)


 


34

















 


EXHIBIT B


 


PRODUCT
SPECIFICATIONS


 


[***]


 


*
Confidential Treatment Request(ed)


 


35

















 


[***]


 


* Confidential Treatment Request(ed)


 


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