Exhibit 10.49


 


***Text Omitted and Filed Separately


Confidential Treatment Requested


Under 17 C.F.R. §§ 200.80(b)(4)


And 240.24b-2


 


Commercial Supply Agreement for
Exenatide


 


This Agreement, effective as of December 23,
2003, is made by and among Amylin Pharmaceuticals, Inc. (“Amylin”) having a
principal place of business at 9360 Towne Centre Drive, San Diego, CA 92121, and Bachem, Inc., a California corporation
(“Bachem”), having a principal place
of business at 3132 Kashiwa Street, Torrance, CA 90505. References to any of Amylin or Bachem includes reference to their
respective Affiliates.


 


Whereas,
Bachem previously manufactured for Amylin a compound referred to as Exenatide
(as defined below).


 


Whereas,
Amylin wishes to engage Bachem to manufacture clinical trial, regulatory registration and
commercial supplies of Exenatide on behalf of Amylin.


 


Whereas,
Bachem desires to manufacture for Amylin clinical trial, regulatory
registration and commercial supplies of Exenatide; and


 


Now,
Therefore, in consideration of the premises and the mutual covenants and
agreements contained herein, Bachem and Amylin agree as follows:


 


1.             Definitions


 


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


 


1.1       “Affiliate” of a party hereto means any entity which
directly or indirectly, through one or more intermediaries, controls, is controlled by or
is under common control with such party where “controlling,” “controlled” and “under common
control” means the direct or indirect beneficial ownership of at least fifty
percent (50%) of the stock, or a fifty percent (50%) or greater interest in the income, of such
party or entity, as applicable.


 


1.2       “Applicable Laws” shall mean all applicable statutes,
ordinances, regulations, rules, or orders of any kind whatsoever of any governmental
authority (including any amendments thereto), applicable to the import, export,
manufacture and distribution of Product, including, without limitation, the
applicable regulations and guidelines of the FDA and all applicable current
good manufacturing
practices, including, without limitation, the cGMPs.


 


1.3       “Bachem Technology” means all technical information,
whether tangible or intangible and whether or not patentable, including
patents, 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, processing or formulation of
Product, which (a) Bachem conceived, reduced to practice, developed or obtained (or which Bachem
has the ability to license or sublicense), or (b)


 


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is otherwise
necessary or useful in the manufacture of the Product.


 


1.4       “Batch Production Records” means the lot production records for the
Batches manufactured by Bachem pursuant to this Agreement.


 


1.5       “cGMPs” shall mean then-current Good Manufacturing Practices as
specified in ICH Guideline Q7A, the
United States Code of Federal
Regulations, or equivalent laws, rules, or regulations of an applicable
Regulatory Authority at the time of manufacture.


 


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


 


1.7       “Contaminant” means any substance contained in the Product that (A)
causes the Product to fail to meet
any Product Specifications, (B) causes the Product to be adulterated within the
meaning the Act, (C) is present in the Product at a level that exceeds the
level allowed under Applicable Laws.


 


1.8       “DMF” shall mean a drug master file for Product in the United States
(as such term is defined in 21 C.F.R. Part 314.420) or Europe.


 


1.9     “Effective
Date” means the later date of execution written on the execution page of this Agreement.


 


1.10         “Facility” means the facility in Torrance,
California where Product is manufactured by Bachem under this Agreement.


 


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


 


1.12         “Hidden Defect” means a defect in any shipment of
Product that could not reasonably be expected
to have been found by diligent and adequate inspection by Amylin pursuant to Section 4.1, such as the presence of any
Contaminant or failure to follow cGMPs.


 


1.13         “Materials” shall mean, collectively, all raw
materials, ingredients and packaging components
required to produce Product in accordance with the Product Specifications.


 


1.14         “NDA” means a New Drug Application to make and/or
sell commercially Product, filed with the FDA (as more fully defined in 21
C.F.R. Part 314.5 et seq.) or
with a Regulatory Authority in any
jurisdiction outside of the United States, and all amendments and supplements
thereto filed therewith.


 


1.15         “Product” means the bulk drug substance,
Exenatide, manufactured under this Agreement.


 


1.16         “Product Specifications” means the written
specifications for Product set forth in Exhibit 1, as amended from time to time
in accordance with the Quality Agreement.


 


1.17         “Purchase Order” means Amylin firm orders for
Product under this Agreement issued on Amylin’s
form of purchase order.


 


1.18         “Quality Agreement” means that certain Quality
Agreement dated as of the Effective Date between Amylin and Bachem containing, identifying and outlining the
specifications, and certain


 


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of the technical and compliance terms and conditions, for the
manufacture of Product under this Agreement. The Quality Agreement is incorporated
into and made a part of this Agreement.


 


1.19         “Regulatory Approval” means (a) in the United
States, approval by the FDA of an NDA for the Product, and satisfaction of any related applicable FDA registration
and notification requirements, if any,
and (b) in any country other than the United States, approval by Regulatory Authorities having jurisdiction over such country
of a single application or set of applications with respect to a Product
comparable to an NDA, and satisfaction of any related applicable regulatory and
notification requirements, if any, including pricing approvals where
applicable, together with any other
approval necessary to make, use, import, package, label, market, and sell
Product commercially in such country.


 


1.20         “Regulatory Authority” means the FDA in the United
States, or the applicable regulatory agency
or entity having the responsibility, jurisdiction, and authority to approve the
manufacture, use, importation,
packaging, labeling, marketing, and sale of Product in any country other than the United States.


 


2.     Purchase and Sale of Product


 


2.1                  Bachem
agrees to manufacture Product using the process described in the Batch
Production Records, subject to the terms and conditions of this Agreement.


 


2.2                  Bachem
agrees to manufacture and supply Exenatide in quantities set forth in Purchase
Orders submitted by Amylin in accordance with this Agreement. The following
table sets forth the quantities of
Product that Amylin estimates, as of the Effective Date, that it will purchase during the period commencing [***] and ending [***].


 


[***]


 


 


[***]


 


Commencing on the Effective
Date Amylin will supply to Bachem rolling [***]
forecasts containing its
estimated requirements of Product, [***]. This may
be a fixed amount or a range of quantities.
Amylin shall update such forecasts every [***].
Amylin shall submit Purchase Orders
specifying the quantity of Product ordered, the required delivery date, and any special instructions. Purchase Orders for
delivery of Product in [***], will
be issued (A) no later than [***],
and (B) at least [***] in advance
of the requested delivery date,
provided that such [***] lead time may be
reduced by [***], if Amylin pre-purchases Materials. The
Purchase Orders issued in accordance with this Section 2.2 will be binding on
both Seller and Buyer.


 


2.3           The price for the Product shall be based on [***] as set forth below and includes the costs of Materials and analytical release
testing. If Materials’ costs or waste disposal costs change by more than [***], the price for the Product may be adjusted, subject to the parties’ mutual written agreement, to reflect
the change in such costs.


 


Prices will be the
following:  [***]


 


 


* Based on
current specifications. The parties agree that changes to the Product Specifications that are set forth in Exhibit 1 as
of the Effective Date to reflect requirements for commercial supply will not
result in any change to the prices set forth


 


* Confidential
Treatment Request(ed)


 


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above; provided,
however that, if such changes to the Product Specifications reflect process
capabilities that are outside the process capabilities demonstrated by Bachem
in manufacturing validation
batches, then the parties will discuss whether such prices would require
adjustment as a consequence.


 


If certain process improvements
can be identified post approval, Bachem and Amylin will jointly decide on a course of action, provided that no
change to the manufacturing process for Products may be implemented without
Amylin’s prior written approval. Bachem will quote for the work this
implementation of changes involves. Amylin can then elect to pursue this
option. Any cost savings that ensue
from the implementation of these changes would be [***] between the parties.


 


2.4           Any federal, state, county of municipal sales or use tax,
excise or similar charge, or other tax assessment (other than that assessed against income), license fee or
other charge lawfully assessed or charged on the manufacture, sale or transportation
of Product sold pursuant to this Agreement
shall be paid by Amylin, provided evidence of such charge is provided to Amylin
in writing.


 


3.     Manufacture of Product


 


3.1   Changes in the manufacturing
site or the materials, equipment, process, or procedures used to manufacture the Products shall be handled by the
parties as stated in the Quality Agreement. Bachem shall obtain Amylin’s prior
written approval before it implements any such change. Amylin shall have the
right to raise with Bachem any perceived deficiencies regarding any aspect of Bachem’s manufacture of Product. In the
event that Amylin raises with Bachem any such deficiency both parties will engage in negotiations regarding
remedial action. Upon mutual agreement,
(A) Bachem shall, at its sole cost, promptly submit to Amylin a written plan to
correct any such deficiency and promptly correct any such deficiency to
Amylin’s satisfaction, (B) Amylin shall reimburse Bachem for any reasonable
incremental one-time costs associated with such changes while any ongoing costs
associated with such changes shall be reviewed by the parties and
allocated between Amylin and Bachem as mutually agreed upon by the parties at
such time. If such corrections are required to bring the Facility into
compliance with Applicable Laws, then Bachem shall bear all associated costs.


 


3.2   Product Specifications may be modified from time to
time by written agreement of the parties without the necessity of amending this
Agreement. However, no changes in the Product Specifications will be made
unless made in accordance with the terms and conditions of the Quality Agreement. If
Amylin requests a change in the Product Specifications that would result in a
material increase in Bachem’s cost of manufacture, the parties shall discuss what
impact, if any,
such change should have on the price of Product. If either Bachem agrees to
implement such
change without additional charge, or Amylin agrees in writing to a proposed
price increase to implement such change, the price change shall become effective only
with respect to those orders of Product that are manufactured in accordance with the modified
Product Specifications.  If a Regulatory Authority
requires a change in  the Product Specifications that would result in a material increase in Bachem’s cost of manufacture,
the parties shall discuss what impact, if any, such change should have on the price of Product and Amylin shall bear the
increased cost.


 


3.3   Bachem and Amylin shall comply with the terms and
conditions of the Quality Agreement.  Bachem shall
manufacture, package, label, and supply Product in


 


* Confidential
Treatment Request(ed)


 


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accordance
with the Product Specifications, cGMPs, the NDA, DMF or other applicable
Regulatory Approvals, and all applicable rules and regulations of Regulatory
Authorities with jurisdiction over the manufacture, packaging, labeling,
use or sale of Product, as they may be amended from time to time. Bachem’s
responsibilities and obligations with respect to the manufacture of Products as
set forth in this Section 3.3 are hereinafter referred to as the “Manufacturing
Requirements.”  Bachem shall perform
such quality control testing prior to shipment of Product to Amylin as is
required to ensure that the Products delivered to Amylin under this Agreement
comply with the Manufacturing Requirements and warranties described in Section
8, which testing shall include, without limitation, the performance of all
required release testing and stability testing using the Amylin Test Methods
and other tests designated by Amylin as found in Appendix A of this Agreement. Bachem shall
perform such tests itself or, with Amylin’s prior written consent, cause to be tested by a
third party, each lot of Product before delivery, and shall provide to Amylin (A) a certificate
of analysis containing the quality control test results for each such lot, and confirming that each
such lot of Product conforms to the Product Specifications (the “Certificate of
Analysis”), (B) a Certificate of Conformance confirming that such lot of
Product was made in accordance with cGMPs and the process defined in the
approved master batch record for such Product, and (C) copies of documents
detailing any deviations from any manufacturing processes then in effect (the documents and
information described in (A), (B) and (C), the “Bachem Release Documents”). Upon
completion of the manufacture and testing of each lot of Product ordered by Amylin under this
Agreement, Bachem shall send all the Bachem Release Documents to Amylin. Amylin
is entitled to rely on the Bachem Release Documents for all purposes of this
Agreement.


 


3.4   Bachem shall be responsible for obtaining any
Materials required for the manufacture of Product, in reasonable quantities
consistent with Amylin’s orders for Product and in accordance with the
requirements of Section 8.1(H). Bachem shall use and rotate all stock of
Materials on a first-in, first-out basis as required by cGMPs. Amylin shall assign lot
numbers and retest dates to each lot of Product, and Bachem shall imprint such lot
numbers and retest dates on each unit of Product shipped as required by cGMPs.


 


3.5   Bachem shall keep complete, accurate, and authentic
accounts, notes, data, and records pertaining to its manufacture, processing, testing,
packaging, storage and distribution of Product, including, without limitation,
master production and control records and Product complaint files, in accordance with
Applicable Laws. In addition, Bachem shall retain samples of Products and
isolated intermediates of each lot manufactured pursuant to this Agreement for
a period of five (5) years after Amylin’s acceptance of such lot. The sample size shall
be twice the size necessary to conduct quality control testing. Bachem shall retain such
records and samples for a period of five (5) years following the date of
manufacture, or longer if required by Applicable Laws, and, upon request,
shall make available to Amylin and its Collaboration Partner copies of such records and portions
of the samples. After such time period, Bachem shall notify Amylin prior to destroying such
records and samples and, at Amylin’s request and expense, shall provide such
records and samples to Amylin. Bachem shall permit Amylin and its Collaboration
Partner and
their respective representatives with access during reasonable business hours
and after reasonable notice to those areas of Bachem’s manufacturing facilities
where Product is manufactured, stored and handled and to manufacturing records,
and testing and control records (including without limitation release and stability
records), of Product manufactured by Bachem, so that Amylin and


 


5

















 


its
Collaboration Partner and their respective representatives may perform a
quality assurance audit of such facilities and activities. Use of all
information gained in the course of audits is restricted to the purpose of
Quality Assurance. Likewise, Bachem shall grant similar access to
governmental regulatory agencies upon reasonable notice so that such agencies
can perform inspections of its facilities.


 


3.6   Bachem shall
promptly advise Amylin of any notice or request it receives from a Regulatory Authority or other governmental agency regarding
inspection of its facilities relating to its manufacture of Product, and shall
permit Amylin and its Collaboration
Partner and their respective representatives to attend such inspection. Bachem shall provide to Amylin and its Collaboration
Partner all correspondence and reports that it receives from a Regulatory
Authority or other governmental agency in
connection with the manufacture of Product or with respect to the facility(ies)
at which Bachem manufactures Product. Bachem shall retain the right to delete information
from these reports that would breach a confidentiality provision with any third
party.


 


3.7   Bachem shall, at its own expense, obtain and maintain the
necessary permits required for its manufacture and supply of the Products in accordance with
this Agreement, including all required facility licenses.


 


3.8   Bachem further agrees to use its commercially
reasonable efforts to assist Amylin and its Collaboration Partner in obtaining
FDA approval of its NDA with respect to Product, as well as approvals from any
other government or agency which may be required for the marketing of Product in any country. Bachem
specifically agrees to cooperate with any inspection by the FDA or other Regulatory
Authority, including but not limited to any inspection prior to approval of Amylin’s or its
Collaboration Partner’s NDA. Bachem shall, on a timely basis, provide Amylin and its
Collaboration Partner with information in Bachem’s possession relevant to its
role as the manufacturer of Products that is reasonably necessary for and
relevant to Amylin’s and its Collaboration Partner’s efforts to obtain and
maintain Regulatory Approvals for Product. Without limiting the generality of
the foregoing, Bachem agrees to establish and maintain a DMF for the Product in
accordance with the requirements of the FDA and any other applicable Regulatory
Authorities, and to provide Amylin and its Collaboration Partner with letters
of access to, and rights to reference, the DMF and any other comparable files.
Bachem shall file and establish the DMF in a timely manner to support Amylin’s
or its Collaboration Partner’s NDA filing, and shall provide to Amylin and its
Collaboration Partner such documentation, data and other information relating
to Products as Amylin or its Collaboration Partner may require for submission to Regulatory
Authorities. Bachem shall also provide, upon request by Amylin, information
concerning its production processes and quality control procedures with respect
to Products.


 


3.9   Each party shall promptly advise the others of any
safety or toxicity problem of which such party becomes aware regarding the
Product.


 


3.10 Bachem shall promptly notify Amylin of any
problems, supply, or other situations that are likely to adversely affect the production of any Product, or its timely
delivery to Amylin in accordance with the Purchase Order therefor. Amylin may
participate in the resolution of any such
problem or production situation unless Amylin agrees with Bachem that such
participation is unnecessary.


 


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3.11    The conditions under which Product is manufactured
shall be provided to Amylin and its Collaboration Partner for inclusion in Amylin’s or
its Collaboration Partner’s regulatory filings. Bachem further agrees to provide to Amylin and its
Collaboration Partner all information regarding any aspect of manufacture of Product
that is necessary and related to Amylin’s or its  Collaboration Partner’s regulatory filings. Bachem also
agrees to authorize the FDA, or other Regulatory Authorities, to inspect any aspect of
Bachem’s manufacture of Product.


 


3.12 The parties agree that Amylin or its Collaboration
Partner shall be the sole and exclusive owner of all right, title and interest
in and to the NDA filed with the FDA and the other Regulatory Authorities outside of
the United States, and that Amylin or its Collaboration Partner shall be the sole and
exclusive owner of any Regulatory Approvals related to Product. Bachem shall assist Amylin and
its Collaboration Partner in the preparation of all documents necessary to effectuate Amylin’s and
its Collaboration Partner’s rights in each NDA and Amylin’s and its Collaboration Partner’s
rights to such Regulatory Approvals, and agrees to transfer, effect, confirm,
perfect, record, preserve, protect and enforce all rights, title and interests
transferred hereunder,
at the reasonable request and expense of Amylin.


 


3.13 Amylin shall disclose to Bachem, or provide Bachem
with access to, the test methods specified in the Product Specifications
(“Amylin Test Methods”) for Bachem’s use solely to perform its obligations
under this Agreement. Bachem understands and agrees that the Amylin Test Methods shall be
the sole and exclusive property and Confidential Information (as defined in Section 10) of Amylin.
Any and all inventions or discoveries, including without limitation, information,
processes, improvements, innovations, suggestions and ideas, whether or not patentable, conceived or
reduced to practice by Bachem, alone or with others, that are related to any or all Amylin Test
Methods, shall be owned solely and exclusively by Amylin. The terms “conceived”
and “reduced to practice” shall be given the meaning of those terms as used and
interpreted
for 35 U.S.C. § 102 (g). Bachem will promptly notify Amylin of any such
invention or
discovery.


 


3.14 During the term of this Agreement, Bachem shall
not manufacture any products containing exendin-4 and/or its analogues or
derivatives covered by an Amylin patent for any party other than Amylin with
the exception of research-grade materials.


 


4.     Acceptance of
Product


 


Not
later than [***] after Amylin’s receipt
of all Bachem Release Documents, Amylin shall examine the Bachem Release
Documents for the Product’s compliance with the Product Specifications and other
warranties in Section 8. Amylin may reject any shipment of Product (or part
thereof) that does not conform with the Product Specifications or other
warranties in Section 8. If Amylin believes that any such shipment does not
comply with the Product Specifications or other warranties, or is otherwise deficient,
Amylin shall promptly, but not later than [***] after receipt of all Bachem Release Documents, notify Bachem.
Any such notice of rejection shall be in writing and shall indicate the reasons
for such rejection. The invoice for any rejected Product shall be cancelled. If
no such notice of rejection is received, Amylin shall be deemed to have
accepted such shipment upon the expiration of the such [***] period. Notwithstanding
the foregoing, if there is subsequently found to be a Hidden Defect in any
shipment of Product, Amylin and Bachem shall enter into discussions in good
faith as to the handling and disposal of the


 


* Confidential
Treatment Request(ed)


 


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defective
shipment, having due regard to where responsibility for such defect lies, with
the understanding
that Bachem shall be responsible with respect to matters existing prior to
delivery of
Product to Amylin.


 


After
any notice of rejection is given, Amylin shall cooperate with Bachem in determining
whether rejection is necessary or justified. Bachem will evaluate process
issues and other reasons for such non-compliance. Bachem shall notify
Amylin as promptly as reasonably possible whether it accepts Amylin’s basis for
any rejection. If Bachem in good faith disagrees with Amylin’s determination that certain Product
does not meet the Product Specifications, such Product shall be submitted to a mutually
acceptable third party laboratory. Such third party shall determine whether
such Product meets the Product Specifications, and the Parties agree that such third party’s
determination shall be final and determinative. The party against whom the
third party
tester rules shall bear all costs of the third party testing. Whether or not
Bachem accepts Amylin’s basis for rejection, promptly on receipt of a notice of
rejection of Product, Bachem shall replace such rejected Product, at its cost,
within [***]. If the third party
tester rules
that the lot meets Product Specifications and the other warranties in Section
8, Amylin shall purchase that lot at the agreed-upon price, irrespective of whether
Bachem has already replaced it. All replacement product shall be invoiced as
well and Amylin is to pay for such product as otherwise provided under the terms of this
Agreement. Amylin may not destroy any lot of Product until it receives written notification from
Bachem that Bachem does not dispute that the lot fails to meet Product Specifications and that
Bachem does not request return of the Product. 
Upon
authorization from Bachem to do so, Amylin shall destroy the Product received
in the rejected delivery promptly at Bachem’s cost and provide Bachem with
certification of such destruction. Amylin shall, upon receipt of Bachem’s request for return,
promptly return said Product or
quality control sample to Bachem, at Bachem’s cost.


 


4.3   In the event Amylin or its
Collaboration Partner shall be required or requested by any Regulatory Authority (or shall voluntarily decide
in good faith) to recall any Product, Amylin or its Collaboration Partner shall coordinate such recall. If a recall
arises due to Bachem’s negligence,
willful misconduct or breach of this Agreement, and does not result from
Amylin’s or its Collaboration Partner’s negligence, willful misconduct or
breach of this Agreement, then Bachem
shall reimburse Amylin and its Collaboration Partner for (i) the purchase price
paid by Amylin to Bachem for such
recalled Product, and (ii) all of Amylin’s and its Collaboration Partner’s
other direct reasonable costs and expenses actually incurred by Amylin or its
Collaboration Partner in connection with the recall including, but not limited
to, costs of retrieving Product already delivered to customers, costs of
replacement Product, costs and expenses Amylin or its Collaboration Partner is
required to pay for notification, shipping and handling charges, and all other costs reasonably related to the recall.
If a recall is due to any reason
other than one that is attributable to Bachem’s negligence, willful misconduct
or breach of this Agreement, Amylin or its Collaboration Partner, as
applicable, shall pay all of the costs and
expenses of the recall.


 


5.      Shipment and Delivery


 


5.1.      Bachem agrees to use its commercially reasonable
efforts to ensure that Product ordered by Amylin hereunder shall be delivered
on the scheduled delivery dates set forth in the relevant purchase orders. Bachem shall prepare Product for
shipment and arrange for shipment of Product
to a location designated in writing by Amylin. Shipment terms are FCA Bachem’s Facility (Incoterms 2000). All shipments must be
accompanied by a packing slip which describes


 


* Confidential
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the articles, states the purchase order number and shows the shipment’s
destination. Bachem agrees to
promptly forward the original bill of lading or other shipping receipt for each
shipment in accordance with Amylin’s
instructions. In accordance with Amylin’s written instructions and at Amylin’s
expense, Bachem will arrange for the shipment of Product by the carrier
designated by Amylin and for
appropriate shipping insurance, and Bachem shall ship Product to Amylin in containers reasonably sufficient for delivery of
Product in accordance with the Product Specifications.


 


5.2.      Each delivery of Product shall be governed by the
terms of this Agreement, and none of the conflicting terms or conditions of Amylin’s purchase order or Bachem’s
purchase order form, acknowledgment
or invoice form shall be applicable, except those specifying special shipping instructions and invoice information consistent
with this Agreement.


 


6.      Invoice


 


6.1   Bachem shall invoice Amylin
with a single invoice concurrently with shipment of all Bachem Release
Documents to Amylin. Product accepted by Amylin shall be shipped by Bachem to Amylin’s designated ship to address immediately upon Amylin’s
acceptance of such Product. Amylin
shall pay Bachem net sixty (60) days from the date of their receipt of invoice.


 


7.         Term and Termination


 


7.1       This Agreement shall commence on the Effective Date
and, unless earlier terminated in accordance with this Article 7, shall continue in effect
for a period of six (6) years thereafter, and shall automatically renew thereafter from year to
year unless terminated by either party upon at least two (2) years prior written notice given to
the other party at any time after the expiry of four (4) years from the
Effective Date.


 


7.2   This Agreement may be terminated as follows:


 


a)     Any party may terminate this Agreement immediately
upon the bankruptcy or insolvency of another party, Any party may terminate this Agreement by giving
the other party one- hundred-twenty (120) days’ prior written notice upon or
after the breach of any material provision of this Agreement by the other party if the
breach is not cured within the one-hundred-twenty (120) day period following
written notice of termination by the non-breaching party. Failure to supply all
quantities of Product ordered on the dates specified in an issued Purchase
Order shall be considered a material breach. 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.


 


b)     Amylin may terminate this Agreement (A) by giving
Bachem sixty (60) days’ prior written notice upon notice by the FDA or other
Regulatory Authority that Bachem is not an approved commercial supplier of
Product or failure of Bachem to successfully complete its Pre-Approval Inspection (PAI) or the
foreign equivalent in applicable jurisdictions outside of the United States where Product may be
distributed, marketed or sold, or (B) by giving Bachem thirty (30) days’ prior
written notice in each of the following situations: (i) the FDA notifies Amylin
that it will not approve the NDA directed to the Product, (ii) Amylin withdraws
the NDA directed to the Product or (iii) Amylin withdraws the Product from the
market. If Amylin terminates this Agreement under any of 7.2 (c)(B)(i), (ii) or
(iii), then Amylin agrees to reimburse Bachem for its reasonable and documented
out-of-pocket costs for Materials


 


9

















 


and for
the direct costs associated with all work in progress related to open Purchase
Orders issued by Amylin on or before the effective termination date.


 


7.3   Termination, expiration, cancellation or
abandonment 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 either party with respect to any antecedent breach of
any of the provisions of this agreement. The provisions of Sections 3.5, 3.6,
3.12, 7.3, 7.4 and 7.5 and Articles 1, 8, 9, 10, 12, 13, 14 and 15 shall survive termination
or expiration of this Agreement.


 


7.4   In the event that this
Agreement is terminated by Amylin pursuant to Section 7.2(a), 7.2(b) or
7.2(c)(i) following the applicable cure period provided in such sections, or in
the event of a Force Majeure
occurrence that causes Bachem to be unable to supply Products in such
quantities as Amylin shall request and in compliance with the delivery periods
set forth in issued Purchase Orders
and Amylin provides written notice to Bachem of its intent to terminate this
Agreement if this situation is
not remedied within the one hundred twenty (120) day period following such
written notice by Amylin, then Bachem shall provide reasonable assistance to
Amylin, at Bachem’s expense, to implement the transfer of manufacturing and
testing responsibility for Product to Amylin or its designee. Such reasonable
assistance shall include all processes, procedures, know-how and data required to perform all aspects of the
site transfer as defined by the FDA under the Changes to an Approved NDA or
ANDA guidelines, including assistance of Bachem personnel in compiling and
transferring this information, but shall not include the direct efforts of a team of Bachem on-site at the new
manufacturing facility. If such on-site personnel commitments are required by
Amylin to effectuate the transfer of manufacturing responsibility, then Amylin
shall reimburse Bachem for the reasonable and direct expenses of providing such
personnel. For purposes of this
Section 7.4, Bachem grants to Amylin an irrevocable, exclusive, worldwide fully paid-up royalty-free license to
use the Bachem Technology, with the right to grant sublicenses, to make and have made Product, effective upon
termination of this Agreement under
the circumstances described in the first sentence of this Section 7.4.


 


7.5 In the event that this Agreement is terminated by Bachem pursuant
to Section 7.2(a) or 7.2(b), then Bachem shall provide reasonable assistance to
Amylin, at Amylin’s expense, to implement
the transfer of manufacturing responsibility for the Products to Amylin or its
designee as described in the preceding paragraph.


 


8.         Representations and Warranties


 


8.1   Bachem represents and
warrants to Amylin, and agrees that, at the time of delivery to Amylin, all Product delivered hereunder: (A)
shall be manufactured in compliance with cGMPs, relevant Regulatory Approvals
filed by Amylin; (B) shall conform to the Product Specifications in effect at the time of delivery; (C) will not be
adulterated within the meaning of the Federal Food, Drug and Cosmetic Act, as
amended, or within the meaning of any applicable state or municipal law or
other Applicable Law in which the definitions of adulteration are substantially
the same as those contained in the
Federal Food, Drug and Cosmetic Act, as such Act and such laws are constituted and effective at the time of
delivery or contain any Contaminant; (D) will not be an article which may not, under the provisions of Sections 404,
505 of 512 of such Act, be introduced into interstate commerce; (E) shall
conform to all Bachem Release Documents associated with the shipment of the Product; (F) shall be packaged,
labeled and shipped in accordance with the Product Specifications in effect at
the time of delivery and the terms of this Agreement; (G) shall be free and clear of any lien or encumbrance.
Bachem represents and warrants that
it shall comply with all Applicable Laws; and (H) shall be manufactured using
amino acid derivative starting materials that are synthetic or of plant origin,
as confirmed in certification
provided to Amylin by Bachem; provided that Product may be manufactured using
amino acid derivative starting materials that are not synthetic or if plant


 


10

















 


origin if Bachem obtains the written approval of Amylin to use such starting materials prior to
their use, and provides Amylin
certification regarding use of such starting materials that contains additional
information regarding extraction,
hydrolysis procedures, organs, type of tissue and country of origin of any animal origin amino acids. In addition, Bachem
represents and warrants that (A) Bachem and its employees, affiliates and agents have never been debarred, or convicted
of a crime for which a person can be
debarred, under subsection (a) or (b) of 21 U.S.C. § 335a, and Bachem 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, Bachem or any other person performing services hereunder
becomes debarred or disqualified, or receives notice of an action or threat of
an action with respect to debarment or disqualification, Bachem shall
immediately notify Amylin, and (B) to the best of Bachem knowledge as of the
Effective Date, the use of the Bachem Technology as contemplated herein does
not infringe any intellectual property rights owned by any third party. Except
as set forth in this Agreement, Bachem makes no warranties, expressed or
implied, with respect to Product, and all other warranties, expressed or
implied, including, without limitation, the implied warranties or
merchantability and fitness for a particular purpose, are hereby disclaimed by
Bachem.


 


8.2   Each party hereby represents and warrants to the
other party that: (a) such party is duly organized, validly existing and in
good standing under the laws of the state or other jurisdiction in which it is
organized; (b) such party has the power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder; (c) this
Agreement has been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable against such party
in accordance with its terms; (d) all necessary consents, approvals and authorizations of all
governmental authorities and other persons required to be obtained by such party in connection
with this Agreement have been obtained, except for those which cannot be obtained prior to the
filing and approval of the NDA; and (e) the execution and delivery of this
Agreement and the performance of such party’s obligations hereunder (i) do not
conflict with or violate any law, regulation, order or other requirement of any
governmental body, court or administrative or other agency having jurisdiction
over such party and (ii) do not conflict with, or constitute a material default or require any
consent under, any agreement, instrument or understanding, oral or written, to which it is a
party or by which it may be bound.


 


8.3   IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY
INDIRECT, INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES INCURRED BY THE OTHER PARTY, WHETHER IN
CONTRACT OR TORT OR BASED ON A WARRANTY, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES. This paragraph shall not be construed to limit a party’s
obligations under Article 9 of this Agreement.


 


9.     Indemnification


 


9.1   Amylin shall defend, indemnify and hold
Bachem and its Affiliates and their respective employees, directors,
officers, shareholders and agents (each, an “Amylin Indemnitee”) harmless against any liability,
judgment, demand, action, suit, loss, damage, cost and other expense (including reasonable
attorney’s fees) (“Liability”) resulting from any third party claims made or proceedings brought
against Bachem to the extent such Liability arises from (i) Amylin’s negligence
or willful act or omission in the possession, use, importation, marketing or
sale of Product,
(ii) Amylin’s material breach of this Agreement, (iii) Amylin’s breach of any representation or
warranty set forth in Article 8, or (iv) any repackaging or use by or on behalf
of


 


11

















 


Amylin
of Product after delivery to Amylin by Bachem hereunder, in each case, except
to the extent Bachem is obligated to indemnify any Amylin Indemnitee for such
claim or proceeding under Section 9.2 below.


 


9.2       Bachem shall defend, indemnify and hold Amylin and
its Collaboration Partner and their Affiliates and their respective employees,
directors, officers, shareholders and agents harmless against any Liability
resulting from any third party claims made or proceeding brought against Amylin
to the extent that such liability arises from (i) Bachem’s negligence or
willful act or omission in the manufacture, storage or delivery of Product;
(ii) Bachem’s material breach of this
Agreement; or (iii) Bachem’s breach of any representation or warranty set forth
in Article 8.


 


Each indemnified party agrees to give the indemnifying party prompt
written notice of any matter upon which such indemnified party intends to base
a claim for indemnification (an “Indemnity Claim”) under Article 9. The
indemnifying party shall have the right to participate jointly with the indemnified party in the
indemnified party’s defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money
damages and which could not result in the indemnified party’s becoming subject
to injunctive or other equitable relief or otherwise adversely affect the
business of the indemnified party in any manner, and as to which the
indemnifying party shall have acknowledged in writing the obligation to
indemnify the indemnified party hereunder, the indemnifying party shall have
the sole right to defend, settle or otherwise dispose of such Indemnity Claim,
on such terms as the indemnifying party, in its sole discretion, shall deem appropriate, provided that the indemnifying party
shall provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement shall
have obtained the written release of
the indemnified party from the Indemnity Claim. The indemnifying party shall obtain the written consent of the indemnified
party, which shall not be unreasonably withheld, prior to ceasing to defend,
settling or otherwise disposing of any Indemnity Claim if as a result thereof the indemnified party would become
subject to injunctive or other equitable relief or the business of the
indemnified party would be adversely affected in any manner.


 


9.3    Each party shall at all times comply, through
insurance, with all statutory workers’ compensation
and employers’ liability requirements covering any and all employees with
respect to activities performed under
this Agreement. In addition to the foregoing, each party shall obtain and maintain, occurrence-based or claims
made Broad Form Comprehensive General Liability
(“BFCGL”) Insurance with a reputable and financially secure insurance
carrier(s) having at least an
Excellent rating (A- rating or above by A.M. Best). Upon a party’s request, the other party shall provide to such requesting
party written evidence reasonably satisfactory to such requesting party of the sufficiency of such
other party’s insurance program.


 


10.      Confidential Information


 


Confidential Information will be as defined by and treated in
accordance with the Confidential Disclosure
Agreement dated February 15, 2002 between Amylin and Bachem, a copy of which is
attached hereto as Exhibit 2, which
shall remain in full force and effect in accordance with its terms. The
parties, however, agree that the following shall apply to confidential
information disclosed under this
Agreement: (A) each party shall use the other party’s confidential information solely for the purposes contemplated
under this Agreement, (B) the non-disclosure and confidentiality obligations shall remain in effect during the term
of this Agreement and for a period of
five (5) years thereafter, and (C) Amylin shall have the right to disclose
Bachem’s confidential information, without Bachem prior consent, to Regulatory
Authorities in accordance with Article 3 and to Collaboration Partner.


 


12

















 


 


11.   Force
Majeure


 


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


 


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


 


“Force
Majeure” shall mean an event beyond the reasonable control of a party
including, but not limited to, fire, flood, sabotage, shipwreck, embargo,
explosion, accident, riot, act of governmental authority (including, without
limitation, acts relating to raw material or product allocation), acts of
God, acts of war, and acts of terrorism.


 


In the
event of a Force Majeure affecting Bachem, Bachem may prorate and allocate manufacturing
capacity among its Affiliates, Amylin and Bachem’s other customers, in proportion to purchases
of products by such Affiliates, Amylin and other customers during the 12-month
period preceding such Force Majeure event Notwithstanding the occurrence of a Force Majeure
event, if Bachem shall be unable to supply Products in such quantities as
Amylin shall request and in compliance with the delivery periods set forth in
this Agreement, Amylin shall be permitted (with no obligation to Bachem) to exercise
its rights under Section 7.4 and have another source manufacture Product on
Amylin’s behalf using the process described in the master batch records for the
Product, and Amylin shall thereafter have no obligation to purchase Products from
Bachem until any contractual obligations that Amylin has assumed in connection
with obtaining a substitute supply of Products shall have terminated. Amylin shall
have no obligation to affirmatively terminate any such contractual arrangements.


 


12.   Notices


 


All notices hereunder shall be in writing and
shall be delivered personally, mailed by overnight delivery, registered or
certified mail, postage prepaid, or given by facsimile and confirmed by any of the foregoing, as
follows:


 


	
  If to Amylin

  	
  Amylin Pharmaceuticals

  
	
   

  	
  9360 Towne Centre Drive

  
	
   

  	
  San Diego, CA 92121

  
	
   

  	
  Telefax No: (858) 552-2212

  
	
   

  	
  Attn. John Grove

  
	
   

  	
  Senior Director

  
	
   

  	
   

  
	
   

  	
  with a copy to the attention of Lloyd A.
  Rowland, Vice President and General Counsel, at the same address as stated above, Telefax No: 858-552-1936.

  



 


13

















 


	
  If to Bachem

  	
  Bachem California

  
	
   

  	
  3132 Kashiwa Street

  
	
   

  	
  Torrance, CA 90505

  
	
   

  	
  Attn. Phillip Ottiger

  
	
   

  	
  Telefax No: 310 530 1571

  
	
   

  	
   

  
	
   

  	
  Bachem Americas

  
	
   

  	
  3132 Kashiwa Street

  
	
   

  	
  Torrance, CA 90505

  
	
   

  	
  Attn. Jose de Chastonay

  
	
   

  	
  TelefaxNo: 310 530 1571

  



 


13.      Binding Effect


 


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


 


14.      Applicable Law


 


This Agreement shall
be construed, interpreted and governed by the laws of California, excluding
its conflicts of laws principles.


 


15.      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 sell the same in connection with the transfer or sale of
substantially its entire business to which this Agreement pertains, whether by merger, sale of stock, sale of assets,
consolidation with another company or otherwise. 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.


 


16.    Entire Agreement


 


This Agreement
constitutes the entire agreement between the parties concerning the subject matter hereof and supersedes all written or oral
prior agreements or understandings with respect thereto. No subsequent
amendment, modification or addition to this Agreement shall be binding upon the
parties hereto unless reduced to writing and signed by the respective
authorized officers of the parties.


 


17.    Severability


 


This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable governmental
regulations, approvals and clearances. If
any term or provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other term or provision hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall
have been held to be invalid, illegal or unenforceable, had never been
contained herein.


 


14

















 


18.      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. Failure by either party 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.


 


19.      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, save only such announcement as in the opinion of legal
counsel to the party making such announcement
is required by law to be made.


 


20.      Exhibits


 


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


 


21.      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.


 


In Witness
whereof, the parties have caused this Agreement to be executed by their duly
authorized representatives on the later date written below.


 


	
  - BACHEM Americas -

  	
  - Bachem, Inc. -

  
	
   

  	
   

  
	
  Jose de Chastonay

  	
   

  	
  Philip Ottiger

  	
   

  
	
   

  	
   

  
	
  Name

  	
  Name

  
	
   

  	
   

  
	
  Signature

  	
  Signature

  
	
   

  	
   

  
	
  President

  	
   

  	
  President &CEO, Bachem, Inc.

  	
   

  
	
   

  	
   

  
	
  Title

  	
  Title

  
	
   

  	
   

  
	
  - Amylin
  Pharmaceuticals, Inc. -

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signature

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title

  	
   

  	
   

  
					



 


15

















 


[***]


 


 


* Confidential
Treatment Request(ed)


 


16

















 


[***]


 


 


* Confidential
Treatment Request(ed)


 


17

















 


[***]


 


 


* Confidential
Treatment Request(ed)


 


18