Exhibit 10.48


 


*** 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 Pramlintide


 


This Agreement, effective as of June 21,
2005, 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 pramlintide acetate (also known as AC137).


 


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


 


Whereas, Bachem desires to manufacture for
Amylin clinical trial, regulatory registration and commercial supplies of
pramlintide acetate; 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, packaging, labeling, 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,


 


1





















 


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) 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 “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.


 


1.7 “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.


 


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


 


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


 


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


 


1.11  “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.


 


1.12 
“Materials” shall mean, collectively, all raw materials, ingredients and
packaging components required to produce Product in accordance with the Product
Specifications.


 


1.13  “NDA” means one or more New
Drug Application(s) 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.


 


1.14  “Product” means the bulk
drug substance, pramlintide acetate, manufactured under this Agreement.


 


2





















 


1.15  “Product Specifications”
means the written specifications for Product set forth in Appendix A, as
amended from time to time in accordance with the Quality Agreement.


 


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


 


1.17  “Quality Agreement” means
that certain Quality Agreement dated as of June 14, 2005, between Amylin and
Bachem containing, identifying and outlining the specifications, and certain 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.


 


1.18  “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.


 


1.19 
“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 Product 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 for delivery during the period commencing January 2006 and ending December 31,
2011.  






	
  2006

  	
   

  	
  2007

  	
   

  	
  2008

  	
   

  	
  2009

  	
   

  	
  2010

  	
   

  	
  2011

  	
   

  
	
  [***]kg-

  	
   

  	
  [***]kg –

  	
   

  	
  [***] to

  	
   

  	
  [***] to

  	
   

  	
  [***] to

  	
   

  	
  [***] to

  	
   

  
	
  [***]kg

  	
   

  	
  [***]kg

  	
   

  	
  [***]kg

  	
   

  	
  [***]kg

  	
   

  	
  [***]kg

  	
   

  	
  [***]kg

  	
   

  






 


The quantities listed are indicative in
nature, are not intended to be binding on the parties and can be revised
periodically to reflect better knowledge of Product demand. However, Bachem
guarantees that it will be able to manufacture said quantities of Product,
provided such Product is ordered in accordance with the terms of this
Agreement.


 










* Confidential Treatment Request(ed)


 


3





















 


Commencing on the Effective Date Amylin will
supply to Bachem rolling [***] non-binding forecasts containing its estimated
requirements of Product, by [***]. This may be a fixed amount or a range of
quantities.  Amylin shall update such
forecasts every [***] ([***]) months. 
Amylin shall submit Purchase Orders specifying the quantity of Product
ordered, the required delivery date, and any special instructions.  Any Purchase Order(s) for delivery of up to
the first [***]kg quantity of Product by [***] in a given [***] will be issued
to Bachem by no later than [***]of the [***]. 
Following the issuance of any Purchase Order(s) for delivery of up to
the first [***]kg quantity of Product in a given [***], any Purchase Order(s)
covering any subsequent quantity of Product for delivery by [***] that [***]
must be issued to Bachem no later than [***] of the [***]. Exact delivery
schedules of individual batches will then be determined between Seller and Buyer,
but in no event shall any batch of Product be delivered to Amylin after the
delivery date specified in the applicable Purchase Order.  The Purchase Orders issued in accordance with
this Section 2.2 will be binding on both Bachem and Amylin.


 


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 [***] % over [***], the price for the Product may be
adjusted, subject to the parties’ mutual written agreement, to reflect the
change in such costs.


2.4                                 Prices
will be the following:  The first [***]kg
of Product ordered in any [***] will cost $[***]/g.  The next [***]kg of Product ordered in [***]
will cost $[***]/g. Any additional orders for Product in [***] will cost
$[***]/g.


2.5                                 Potential
Product overages will be tabulated after the delivery of the last batches made
to satisfy total [***] Product orders. 
Bachem will determine the quantity of batches needed to fulfill the
total Product Purchase Order(s). Any Product produced in excess of the total
quantity of Product ordered by Amylin pursuant to Product Purchase Order(s)
will be considered as Product overages. 
Amylin may elect, in its sole discretion, to purchase said overages of
Product for the following prices: The first [***]g of  Product overage at a price of $[***]/g, the
next [***]g of Product overages at $[***]/g and any overages of Product in
excess of [***]g will cost $[***]/g.


 


•                  Prices
are based on current Product 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 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.  Any change in pricing would require the
written consent of both parties.


•                  Pricing
also includes stability testing of one single lot per calendar year, according
to the protocol given in Appendix A.


 


2.6           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


 










* Confidential Treatment
Request(ed)


 


4





















 


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 accordance with the Product
Specifications, cGMPs, the NDA, DMF or other applicable Regulatory Approvals,
and all Applicable Laws.  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 (as defined below) 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


 


5





















 


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 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 provide
Amylin and its 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 its
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 representatives to
attend such inspection.  Bachem shall
provide to Amylin 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


 


6





















 


required facility licenses.


 


3.8 Bachem further agrees to use its
commercially reasonable efforts to assist Amylin in obtaining FDA approval of
its NDA with respect to Product, as well as Regulatory Approvals from any other
Regulatory Authority.  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 NDA.  Bachem shall,
on a timely basis, provide Amylin 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 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 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 NDA filing,
and shall provide to Amylin such documentation, data and other information
relating to Products as Amylin 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 therefore.  Amylin
may participate in the resolution of any
such problem or production situation unless Amylin agrees with Bachem that such
participation is unnecessary.


 


3.11 
The conditions under which Product is manufactured shall be provided to
Amylin for inclusion in Amylin’s regulatory filings.  Bachem further agrees to provide to Amylin
all information regarding any aspect of manufacture of Product that is
necessary and related to Amylin’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 shall be the sole and exclusive owner of
all right, title and interest in and to any NDA filed with the FDA and the
other Regulatory Authorities outside of the United States, and that Amylin
shall be the sole and exclusive owner of any Regulatory Approvals related to
Product.  Bachem shall assist Amylin in
the preparation of all documents necessary to effectuate Amylin’s rights in
each NDA and Amylin’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


 


7





















 


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 and shall transfer, effect, confirm,
perfect, record, preserve, protect and enforce all rights, title, and interests
therein to Amylin.


 


3.14    During
the term of this Agreement, Bachem shall not manufacture any products
containing pramlintide acetate or derivatives covered by an Amylin patent for
any party other than Amylin.


 


4.  Acceptance
of Product


 


4.1 Not later than [***] days 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 to 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 [***] days
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 such [***]-day 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 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. Bachem shall promptly notify Amylin in writing if it becomes aware that
any Products manufactured by Bachem are defective or do not conform to the
Product Specifications or other warranties in Section 8, which notice shall
identify in reasonable detail the nature of the defect or non-conformity and
the lot or batch of Products affected.


 


4.2 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 [***]
([***]) days.  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


 










* Confidential Treatment
Request(ed)


 


 


8





















 


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 shall be required or
requested by any Regulatory Authority (or shall voluntarily decide in good
faith) to recall any Product, Amylin 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 negligence, willful misconduct or breach of this Agreement, then
Bachem shall reimburse Amylin for (i) the purchase price paid by Amylin to
Bachem for such recalled Product, and (ii) all of Amylin’s other direct
reasonable costs and expenses actually incurred by Amylin 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
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
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 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


 


9





















 


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 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) Either party may terminate this Agreement
by written notice to the other party immediately (i) upon the institution by
such other party of voluntary proceedings in bankruptcy or insolvency, or (ii)
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 (iii) sixty (60) days
after the appointment of a receiver or trustee for the assets of business of
the other party (unless such appointment is dismissed or set aside within such
60-day period);


 


b) Either party may terminate this Agreement
by giving the other party ninety (90) 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 ninety (90) 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.


 


c) 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 any NDA directed to
the Product, or must withdraw the Product from the market, (ii) Amylin
withdraws any NDA directed to the Product or (iii) Amylin withdraws the Product
from the market. If Amylin terminates this Agreement under any of Section
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 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, 3.13, 4.3, 7.3, 7.4 and 7.5 and Articles 1, 8, 9, 10, 11, 12, 13, 14
and 15 shall survive termination or


 


10





















 


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 ninety (90) 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; 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 origin if Bachem obtains the written approval of Amylin
to use such starting materials prior to


 


11





















 


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. 
Bachem represents and warrants that it shall comply with all Applicable
Laws.  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, and, 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’s 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 of 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 or damages available for breach of the
obligations under Article 10.


 


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”) incurred by such Amylin
Indemnitee resulting from any third party claims made or proceedings brought
against Bachem or other


 


12





















 


Amylin Indemnitee 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 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 Affiliates and their respective employees, directors, officers,
shareholders and agents harmless against any Liability incurred by any of them
resulting from any third party claims made or proceeding brought against Amylin
or any such indemnitee 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.


 


13





















 


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.


 


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 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 and
similar events beyond the reasonable control of the applicable party.


 


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


 


14





















 


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, VRM and Strategic Sourcing

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  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.

  
	
   

  	
   

  	
   

  
	
  If to Bachem

  	
   

  	
  Bachem California

  3132 Kashiwa Street

  Torrance, CA 90505

  Attn. Phillip Ottiger

  Telefax No: 310 530 15 71

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Bachem Americas

  3132 Kashiwa Street

  Torrance, CA 90505

  Attn. José de
  Chastonay

  Telefax No: 310 530 15 71

  



 


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.  


 


14.          Applicable
Law


 


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


 


15





















 


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.


 


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.


 


16





















 


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. -

  
	
   

    José de Chastonay

  	
   

  	
   

    Philip Ottiger

  
	
    Name

  	
   

  	
    Name

  
	
  

    /s/ José de Chastonay 6/22/05

  	
   

  	
  

    /s/ Philip Ottiger  6/21/05

  
	
    Signature

  	
   

  	
    Signature

  
	
   

    President

  	
   

  	
   

    President & COO, BACHEM, Inc.

  
	
    Title

  	
   

  	
    Title

  
	
   

  	
   

  	
   

  



 


	
     -  Amylin Pharmaceuticals, Inc. -

  
	
   

    Gregg
  Stetsko, Ph.D.

  
	
    Name

  
	
  

    /s/ Gregg Stetsko   6/28/05

  
	
    Signature

  
	
  

    Vice
  President Operations

  
	
    Title

  



 


17





















 


Exhibit 1/Appendix A


 


Contractual Specification for Pramlintide Acetate (AC137) Drug Substance


 


SEQUENCE:             [***]


 


	
  TEST

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.   [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.   [***]

  	
   

  	
  [***]    [***]
  to [***] mole

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]    [***] to [***]
  mole

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.   [***]

    ([***])

  	
   

  	
  [***]% to
  [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.   [***]

    ([***])

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.   [***] 

  	
   

  	
  3 [***]% 

  	
   

  	
  [***] 

  	
    

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.   [***]

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  



 










* Confidential Treatment
Request(ed)


 


18





















 


	
  8.   [***]  ([***])†

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.   [***]  ([***])
  †

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10. [***]  ([***])†

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TEST

  	
   

  	
  SPECIFICATION

  	
   

  	
  METHOD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11. [***] ([***])

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  12. [***]

  	
   

  	
  3 [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13. [***]

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14. [***] ([***]) †

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15. [***] ([***]) †

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. [***] ([***]) †

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17. [***] ([***])

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  18. [***]

  	
   

  	
  [***]o to
  [***]o

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  19. [***]

    ([***])

  	
   

  	
  [***]

  	
   

  	
  [***]

  ([***])

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  20. [***]

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  21. [***]

  	
   

  	
  [***]% to
  [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  22. [***]

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  23. [***]

  	
   

  	
  [***]                                   £
  [***] ppm

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]                                   £
  [***] ppm

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]     £
  [***] ppm

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]     £
  [***] ppm

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  24. [***]

  	
   

  	
  £ [***] CFU/g

  	
   

  	
  [***]

  	
   

  



 










* Confidential Treatment
Request(ed)


 


19





















 


	
  25. [***] ([***])

  	
   

  	
  £ [***] Daltons

  	
   

  	
  [***]

  ([***])

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  26. [***]

    ([***])

  	
   

  	
  < [***]
  AU

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  27. [***]

    ([***])

  	
   

  	
  [***]% -
  [***]%

  	
   

  	
  [***]

  	
   

  



 










* Confidential Treatment
Request(ed)


 


20





















 


Exhibit 2


 


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


 


CONFIDENTIAL
DISCLOSURE AGREEMENT


 


THIS AGREEMENT is entered
into as of February 15, 2002 by and between AMYLIN
PHARMACEUTICALS, INC., a Delaware corporation (“AMYLIN”), having a
place of business at 9373 Towne Centre Drive, Suite 250, San Diego, California
92121, and BACHEM, INC., a California corporation (“RECIPIENT”),
with offices at 3132 Kashiwa Street, Torrance, California.


 


RECITALS


 


WHEREAS AMYLIN owns or is
in possession of certain proprietary information relating to its products and
research efforts, including therapy for and diagnosis of Type I and Type II
diabetes mellitus, obesity and dyslipidemia and other metabolic and
cardiovascular disorders, and compounds, procedures and processes related
thereto (collectively, the “Products and Research”); and


 


WHEREAS RECIPIENT
desires to be made aware of, and AMYLIN is willing to disclose on a
confidential basis, certain information relating to the Products and Research
solely to allow RECIPIENT to evaluate one or more mutual business relationships
(each an “Evaluation”) which the parties have agreed to discuss; and


 


NOW, THEREFORE, in consideration of the
foregoing, and of the mutual covenants, terms and conditions hereinafter
expressed, RECIPIENT and AMYLIN agree as follows:


 


AGREEMENT


 


1.             “Confidential
Information” shall mean information whether written or oral, relating to the
Products and Research, financial, business and other information of AMYLIN,
including patent disclosures, patent applications, structures, models,
techniques, trade secrets, know-how, processes, compositions, compounds,
apparatuses, projections, customer information, and business and marketing
plans disclosed by AMYLIN or its agents, to RECIPIENT or obtained by RECIPIENT
through observation or examination, but only to the extent that such foregoing
information is identified or marked as “confidential”.


 


2.             RECIPIENT agrees the Confidential
Information is proprietary information of AMYLIN and that for a period of five
(5) years from the date of disclosure, RECIPIENT will not disclose any of the
Confidential Information to any third parties, without the written consent of
AMYLIN (except in accordance with the terms of Section 4 or Section 6
below).  RECIPIENT agrees not to use any
of the Confidential Information at any time except for the purposes of an
Evaluation and not to make any chemical analysis of any material without the
written consent of AMYLIN.


 


3.             The
obligations of confidentiality and non-use shall not apply to information
which, as established by written records:


 


a.             is publicly known prior to
disclosure or has become publicly known, without fault on the part of
RECIPIENT, subsequent to disclosure hereunder; or


 


b.             is otherwise known by RECIPIENT
prior to disclosure hereunder or is generated for RECIPIENT by persons who have
not had access to or knowledge of the Confidential Information;  or


 


21





















 


c.              is hereafter received by RECIPIENT
at any time from a source other than AMYLIN or its agents, lawfully having
possession of such information and under no obligation of confidentiality with
respect to such information.


 


4.             RECIPIENT agrees that any
disclosure of the Confidential Information will only be to employees or agents
of RECIPIENT on a need to know basis; provided that (i) such employees and
agents are bound by written agreements to maintain in confidence and not use
the Confidential Information under terms at least as restrictive as the terms
of this Agreement, and (ii) RECIPIENT will remain liable for any breach by its
employees or agents of any obligations hereunder.  RECIPIENT further agrees, upon request, to
identify to AMYLIN those persons to whom the Confidential Information was
disclosed.  Confidential Information
disclosed prior to the date of this Agreement for purposes of an Evaluation
shall be deemed to fall within the scope of this Agreement.


 


5.             RECIPIENT agrees to promptly return
to AMYLIN all tangible items relating to the Confidential Information,
including all written materials, photographs, models, or samples and the like
and all copies thereof, upon completion of an Evaluation (except for a single
archive copy which may be retained for the sole purpose of determining the
scope of the obligations under this Agreement).


 


6.             In the event that RECIPIENT is
required by law, regulation, or court order to disclose any Confidential
Information, RECIPIENT agrees to 
promptly notify AMYLIN of such demand prior to such disclosure and to
give AMYLIN a reasonable opportunity to contest such disclosure.  Such disclosed information shall remain
Confidential Information.


 


7.             This
Agreement may not be assigned by RECIPIENT and shall not be construed to grant
any license or other rights to the Confidential Information to RECIPIENT.


 


8.             RECIPIENT’s
evaluation of the Confidential Information shall be at its own risk and
RECIPIENT agrees to hold harmless and to indemnify AMYLIN against any and all
claims, judgments, costs, awards, expenses (including reasonable attorneys’
fees), and liabilities of every kind arising from any use of the Confidential
Information by RECIPIENT.


 


9.             RECIPIENT shall not disclose the name of AMYLIN, the
existence of this Agreement, or the subject matter hereof in any publicity,
advertising, or public announcement without AMYLIN’s written consent.


 


10.           This Agreement sets forth the entire
agreement between AMYLIN and RECIPIENT, and fully supersedes any and all prior
and contemporaneous agreements or understandings pertaining to the subject
matter hereof.  No modification to this
Agreement shall be effective unless in writing and signed by both parties.


 


11.           The failure of AMYLIN to insist upon
strict performance of any provision of this Agreement or to exercise any right
hereunder shall not constitute a waiver of that provision or right under this
Agreement or of any other provision or right under this Agreement.  If any provision of this Agreement is
declared invalid, illegal or unenforceable, such provision shall be severed and
all remaining provisions shall continue in full force and effect.


 


12.           This Agreement shall be construed and
enforced in accordance with the laws of the State of California (except its
choice of law rules), and RECIPIENT hereby submits to the jurisdiction and
venue of the California courts, both state and federal.  RECIPIENT acknowledges that improper
disclosure could cause irreparable harm to AMYLIN and agrees that AMYLIN may
seek injunctive relief to enforce this Agreement.


 


13.           This Agreement shall be effective as
of the date first written above, and shall remain in full force and effect
until terminated by either party on thirty (30) days written notice; provided
that the terms of this Agreement shall remain in effect with respect to any
Confidential Information disclosed prior to such termination date.


 


22





















 


IN WITNESS WHEREOF, the
parties have caused this Agreement to be executed by their duly authorized
representatives as of the day and year above written.


 


	
  AGREED AND ACCEPTED:

  	
  AGREED AND ACCEPTED:

  
	
   

  	
   

  
	
  Bachem, Inc.

  	
  Amylin Pharmaceuticals, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
     /s/ Jose de Chastonay

  	
   

  	
  By:

  	
   

  	
  /s/  Lloyd A. Rowland

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
    Jose de Chastonay

  	
   

  	
  Name:

  	
  Lloyd A. Rowland

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   President

  	
   

  	
  Title:

  	
   

  	
  Vice President and General Counsel

  	
   

  
										



 


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