Document:

Exhibit 10.48

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

And 240.24b-2

 

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

 

EXENATIDE
MANUFACTURING AGREEMENT

 

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

 

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

 

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

 

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

 

1.                                      Definitions

 

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

 

1.1                                 “Adjustment Date”
shall have the meaning ascribed to it in Paragraph 2.4 hereof.

 

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

 

 

CONFIDENTIAL

 

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

 

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

 

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

 

1.5                                 “Annual Adjustment
Notice” shall have the meaning ascribed to it in Paragraph 2.4 hereof.

 

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

 

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

 

2

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

3

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

4

 

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

 

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

 

1.30                           “MALLINCKRODT Technology”
means all technical information, whether tangible or intangible and whether or
not patentable, including patents, patent applications and any method,
procedure, process, assay, composition of matter, trade secret, invention,
technology, information or other subject matter, including license application
materials and all supporting documents, specifications for materials (including
purification techniques), data, information (including information contained in
registration dossiers, drug master files and other documents filed with
regulatory authorities), quality control, validation and equipment necessary or
useful for the manufacture, production, scale-up and processing of Product,
which is conceived, reduced to practice, developed, owned or licensed by
MALLINCKRODT and necessary or useful in the manufacture of Product.

 

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

 

1.32                           “Nominal Lot” means a Lot
containing at least [***] grams ([***]g) of Product or such other minimum
quantity of Product as specified in any applicable Purchase Order.

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

5

 

1.35                           “Product Costs” shall have
the meaning ascribed to it in Paragraph 2.4 hereof.

 

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

 

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

 

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

 

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

 

1.40                           “Quality Agreement” means
the Quality Agreement dated as of the Effective Date between AMYLIN and
MALLINCKRODT containing, identifying, and outlining the specifications, and
certain of the technical and regulatory terms and conditions, for the
manufacture of Product under this Agreement. The Quality Agreement is
incorporated into this Agreement and made a part hereof.  However, it is understood that in the event
of any conflict of inconsistency between the terms of the Quality Agreement and
any other terms or conditions of this Agreement, the latter shall prevail.

 

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

 

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

 

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

 

6

 

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

 

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

 

2.                                      Purchase
and Sale of Product

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

7

 

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

 

(i)                                                        during
the period from the Effective Date through the end of the first Contract Year
hereof (i.e., during the period from October 1, 2003 through September 30,
2004) a minimum of [***] ([***]) [***] (or [***]) of Product which will consist
of the Product Validation Lots,

 

(ii)                                                     during
the second Contract Year, a minimum of [***] ([***]) [***] (or [***]) of
Product,

 

(iii)                                                  during
the third Contract Year hereof, a minimum of [***] ([***]) [***] (or [***]) of
Product, and

 

(iv)                                                 during
the fourth Contract Year and every subsequent Contract Year thereafter, at
least [***] percent ([***]%) of the total quantity of Product purchased by
AMYLIN during each Contract Year for the manufacture of Exenatide Injection
Drug for commercial sale anywhere in the world that MALLINCKRODT has authorized
reference of its Drug Master File for Product or [***] ([***]) [***] of Product
whichever is greater.

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

8

 

Product. Based on the foregoing, AMYLIN will
pay to MALLINCKRODT a per gram price for Product (“Product Price”) in
accordance with the following:

 

(i)                                                        if
in any given Contract Year the amount of Product ordered for delivery is less
than or equal to [***] ([***]) [***], the price per gram will be $[***],

 

(ii)                                                     if
in any given Contract Year the amount of Product ordered for delivery is
greater than [***] ([***]) [***] but less than or equal to [***] ([***]) [***],
the price per gram will be $[***],

 

(iii)                                                  if
in any given Contract Year the amount of Product ordered for delivery is
greater than or equal to [***] ([***]) [***] but less than or equal to [***]
([***]) [***], the price per gram will be $[***],

 

(iv)                                                 if
in any given Contract Year the amount of Product ordered for delivery is
greater than [***] ([***]) [***] but less than or equal to [***] ([***]) [***],
the price per gram will be $[***],

 

(v)                                                    if
in any given Contract Year the amount of Product ordered for delivery is
greater than [***] ([***]) [***] but less than or equal to [***] ([***]) [***],
the price per gram will be $[***], and

 

(vi)                                                 if
in any given Contract Year the amount of Product ordered for delivery is
greater than [***] ([***]) [***], the price per gram will be $[***].

 

The Product Prices set forth in the
immediately preceding sentence shall be firm through the first Contract Year
ending on September 30, 2004, the date of October 1, 2004 being hereinafter
referred to as the “Adjustment Date”. From and after the Adjustment Date, the
Product Prices shall be adjusted to reflect increases or decreases in the cost
to MALLINCKRODT of all raw materials, directly associated regulatory compliance
costs and all

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

9

 

directly allocated labor (all of which costs
are hereinafter referred to as “Product Costs”) [***] compared to the
immediately preceding Contract Year, in accordance with the following
procedures. Within fifteen (15) days after the end of each Contract Year hereunder
during the term hereof, MALLINCKRODT will notify AMYLIN in writing of the
amount by which its Product Costs hereunder have changed during the immediately
preceding Contract Year period and, if applicable, the adjusted Product Price
to be charged for the next Contract Year just commenced as a consequence of
such changes (“Annual Adjustment Notice”). The amount of any change in the
Product Prices as set forth in any Annual Adjustment Notice shall be effective
for all Product invoices by MALLINCKRODT to AMYLIN in accordance herewith
during the Contract Year for which such Annual Adjustment Notice is issued.

 

2.5                                 If, with respect to
any given Contract Year, it is clear that the annual volume assumptions on
which the Product Prices reflected in any one or more invoices for Product
shipped to AMYLIN during such Contract Year are based are incorrect, then
within thirty (30) days after the end of such Contract Year, MALLINCKRODT will
send corrected invoices to AMYLIN indicating the actual per gram price for Product
shipped during such Contract Year with respect to such invoices based on the
actual volume of Product ordered for delivery during such Contract Year. If, on
the basis of all such corrected invoices with respect to a particular Contract
Year, when considered in the aggregate, the amount paid or payable by AMYLIN
for Product shipped during such Contract Year against invoices previously
issued by MALLINCKRODT is in excess of the amount payable by AMYLIN pursuant to
all such corrected invoices then MALLINCKRODT shall, contemporaneous with the
delivery of such corrected invoices and at AMYLIN’s option, give AMYLIN a full
refund of the excess amount or, with respect to any previously issued but as
yet unpaid invoice, issue an appropriate credit equal to the excess amount of
any such invoice. If, on the basis of all such corrected invoices with respect
to a particular Contract Year, when considered in the aggregate, the amount
paid or payable by AMYLIN for Product shipped during such Contract Year against
invoices previously issued by MALLINCKRODT is less than the amount payable by
AMYLIN pursuant to all such corrected invoices, then AMYLIN shall, within
thirty (30) days after the receipt of such

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

10

 

corrected invoices, pay to MALLINCKRODT the
full additional amount due as reflected on such corrected invoices.

 

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

 

2.7                                 At the time of
shipment by MALLINCKRODT to AMYLIN of any Lot hereunder, MALLINCKRODT shall
submit to AMYLIN an invoice setting forth the total

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

11

 

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

 

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

 

3.                                       Manufacture
of Product; Recordkeeping; Regulatory

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

12

 

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

 

(ii) in the event MALLINCKRODT requests any
such changes be made, other than changes requested by any Governmental Agency
or required to bring the Facility into compliance with Applicable Laws or to meet
Validation Requirements, all costs reasonably required in connection with such
changes shall be paid as mutually agreed by both parties; and

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

13

 

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

 

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

 

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

 

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

 

14

 

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

 

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

 

15

 

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

 

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

 

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

 

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

 

16

 

4.                                       Recalls
and Similar Actions

 

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

 

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

 

5.                                       Shipment
and Delivery

 

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

 

17

 

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

 

6.                                      Acceptance/Rejection
of Product

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

18

 

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

 

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

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

19

 

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

 

7.                                       Term and Termination

 

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

 

7.2                                 This
Agreement may be terminated as follows:

 

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

 

20

 

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

 

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

 

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

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

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

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

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

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

 

21

 

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

 

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

 

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

 

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

 

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

 

22

8.                                Warranties

 

8.1                                 MALLINCKRODT
represents, warrants, and covenants that

 

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

 

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

 

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

 

c)                                    not be adulterated
within the meaning of the FDCA or any Applicable Laws in which the definition
of adulteration is substantially the same as in the FDCA (as such Applicable
Laws are constituted and effective at the time of delivery), and will not be an
article which may not, under the FDCA or any other Applicable Laws, be
introduced into interstate commerce,

 

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

 

e)                                    be in undamaged
containers;

 

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

 

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

 

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

 

23

 

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

 

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

 

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

 

9.                                    Indemnification

 

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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

24

 

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

 

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

 

9.3                                Procedures.

 

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

 

25

 

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

 

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

 

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

 

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

 

26

 

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

 

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

 

10.                               Confidential
Information

 

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

 

27

 

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

 

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

 

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

 

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

 

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

 

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

 

28

 

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

 

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

 

11.                               Force
Majeure

 

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

 

29

 

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

 

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

 

13.                            Notices

 

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

 

30

 

	
  If to AMYLIN:

  	
  Amylin
  Pharmaceuticals, Inc.

  
	
   

  	
  9360 Towne
  Centre Drive, Suite 110

  
	
   

  	
  San Diego,
  California 92121

  
	
   

  	
  Attn: John
  Grove, Senior Director of Manufacturing

  
	
   

  	
  Fax No.:
  (858) 558-0290

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Amylin
  Pharmaceuticals, Inc. 9360

  
	
   

  	
  Towne Centre
  Drive, Suite 110

  
	
   

  	
  San Diego,
  California 92121 Attn:

  
	
   

  	
  Lloyd A.
  Rowland, Esq., Vice

  
	
   

  	
  President
  and General Counsel

  
	
   

  	
  Fax No.:
  (858) 552-1936

  
	
   

  	
   

  
	
  If to
  MALLINCKRODT:

  	
  Mallinckrodt
  Inc.

  
	
   

  	
  P.O. Box
  5840 675

  
	
   

  	
  McDonnell
  Blvd. St. Louis,

  
	
   

  	
  Missouri
  63134 Attn:

  
	
   

  	
  Michael J.
  Collins Fax No.:

  
	
   

  	
  314-654-6020

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Mallinckrodt
  Inc.

  
	
   

  	
  P.O. Box
  5840 675

  
	
   

  	
  McDonnell
  Blvd. St. Louis,

  
	
   

  	
  MO 63134

  
	
   

  	
  Attn: C.
  Stephen Kriegh

  
	
   

  	
  Fax No.: 314-654-7181

  

 

31

 

14.                               Binding
Effect

 

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

 

15.                               Independent
Contractor

 

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

 

16.                               Assignment

 

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

 

32

 

17.                               Entire
Agreement

 

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

 

18.                               Severability

 

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

 

19.                           Waiver
- Modification of Agreement

 

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

 

33

 

20.                               Publicity

 

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

 

21.                               Exhibits

 

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

 

22.                               Governing
Law

 

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

 

23.                               Counterparts

 

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

 

24.                               Headings

 

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

 

34

 

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

 

	
  MALLINCKRODT INC.

  	
  AMYLIN PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  BY:

  	
   

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										

 

35

 

EXHIBIT A

 

STRUCTURE OF EXENATIDE COMPOUND

 

EXENATIDE Sequence: The sequence of said EXENATIDE shall be:

[***]

 

[***]: Said
EXENATIDE shall be [***] from a [***].

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

36

 

EXHIBIT B

 

PRODUCT SPECIFICATIONS

 

Purchase Specification AC2993 (Mallinckrodt)

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] to
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] mole
  ratio

  	
   

  	
   

  
	
  [***] avg.
  [***] by [***]

  	
   

  	
  [***]
  Daltons

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  Consistent
  with [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  [***] by
  [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  Total [***]
  by [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  Individual
  [***]

  	
   

  	
  [***]%  [***]% or greater

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

37

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  
	
  Total [***]
  by [***]

  	
   

  	
  [***]%

  	
   

  	
  [***]

  
	
  Individual
  [***] by [***]

  	
   

  	
  [***]%[***]%
  or greater

  	
   

  	
  [***]

  
	
  [***] by
  [***]

  	
   

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

  	
   

  	
  [***]

  
	
   

  	
   

  	
  ([***]%):

  	
   

  	
   

  
	
   

  	
   

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

  	
   

  	
   

  

 

Purchase Specification AC2993 (Mallinckrodt) - Continued

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
   

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
   

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
   

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
   

  
	
  [***]

  	
   

  	
  £
  [***]% ([***])

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***] ppm

  	
   

  	
   

  
	
   

  	
   

  	
  Report
  individual values

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***] EU/mg

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]/g

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  Report
  Result

  	
   

  	
  [***]

  
	
  [***]
  analysis

  	
   

  	
  Report
  Result

  	
   

  	
  [***]

  
	
  [***] of
  [***]

  	
   

  	
  [***] at
  [***] mg/mL in [***]

  	
   

  	
  [***]

  

 

[***] Method

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

38Exhibit
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)

 

1

 

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

 

2

 

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 January 1, 2004 and ending December
31, 2009.

 

	
  2004

  	
   

  	
  2005

  	
   

  	
  2006

  	
   

  	
  2007

  	
   

  	
  2008

  	
   

  	
  2009

  	
   

  
	
  [***] 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.

 

Commencing on the Effective Date Amylin will
supply to Bachem rolling [***] 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. Purchase Orders for delivery of
Product in any [***], will be issued (A) no later than [***] of the [***], and
(B) at least [***] months in advance of the requested delivery date, provided
that such [***] month lead time may be reduced by [***] months, 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 [***]% over [***], 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:

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

3

 

	
  [***]kg

  	
   

  	
  $

  	
  [***]/g*

  	
   

  
	
  [***]kg

  	
   

  	
  $

  	
  [***]/g*

  	
   

  
	
  [***]kg

  	
   

  	
  $

  	
  [***]/g*

  	
   

  
	
  [***]kg

  	
   

  	
  $

  	
  [***]/g*

  	
   

  

 

* 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 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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

4

 

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 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

 

(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 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.

 

6

 

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.

 

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 [***] 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 with the
Product

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

7

 

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 the 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.

 

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 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

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

8

 

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 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.

 

9

 

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 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

 

10

 

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 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.

 

11

 

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
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,

 

12

 

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.

 

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

  

 

13

 

	
   

  	
   

  	
  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.

  
	
   

  	
   

  	
   

  
	
  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

 

14

 

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.

 

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

 

	
   

  	
   

  	
  Product Number: [***]

  	
   

  	
   

  	
  SPECIFICATION

  
	
  BACHEM

  	
   

  	
   

  	
   

  	
   

  
	
   

  
	
  Effective Date:

  [***]

  	
  Specification No.:
[***]

  	
   

  	
  Supersedes:
[***]

  	
   

  	
  Page
  1 of 3

  
	
   

  
	
  Product Name:

  	
   

  	
   

  	
   

  	
  Manufacturing Approval

  	
   

  	
  Date*

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Exenatide
  (Exendin-4, AC2993)

  	
   

  	
   

  	
   

  	
  Quality Control Approval:

  	
   

  	
  Date:

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Quality Assurance Approval

  	
   

  	
  Date:

  
									

 

	
  Lot
  Number:

  	
   

  	
  Date:

  	
   

  	
  Source:

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Batch
  Size:

  	
   

  	
  No.
  of Containers Sampled:

  	
   

  	
  No.
  of Containers:

  

 

MOLECULAR WEIGHT: [***] g/mol

STRUCTURE:    [***]

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  1.  [***]:

  	
   

  	
  None

  	
   

  	
  [***]
  to [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  2.  [***]:

  	
   

  	
  [***]
  at [***] mg/mL in [***]

  	
   

  	
  None

  	
   

  	
  [***]

  	
   

  	
   

  
	
  3.  [***]

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

16

 

	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]
  mole

  	
   

  	
  [***]

  	
   

  	
   

  
	
  4.  [***]:

  	
   

  	
  None

  	
   

  	
  [***] +[***]

  	
   

  	
  Protocol
  no.

  [***]([***])

  	
   

  	
   

  

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

17

 

	
   

  	
   

  	
  Product Number: [***]

  	
   

  	
   

  	
  SPECIFICATION

  
	
  BACHEM

  	
   

  	
   

  	
   

  	
   

  
	
   

  
	
  Effective Date:

  [***]

  	
  Specification No.:
[***]

  	
   

  	
  Supersedes:

  [***]

  	
  Page
  2 of 3

  
	
   

  
	
  Product Name:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Date:

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   Exenatide
  (Exendin-4, AC2993)

  	
   

  	
   

  	
   

  	
  Quality
  Control Approval:

  	
   

  	
  Date:

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Quality
  Assurance Approval:

  	
   

  	
  Date:

  
										

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5. [***]:

  	
   

  	
  None

  	
   

  	
  Consistent
  with [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6. [***]:

  	
   

  	
  None

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7. [***]: (By [***])

  	
   

  	
  None

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  ([***])

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8. [***]: (By [***])

  	
   

  	
  £ [***]%

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  ([***])

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9. [***] BY [***]:

  	
   

  	
  £ [***]%

  	
   

  	
  >
  [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10. TOTAL [***] BY [***]

  	
   

  	
  £ [***]%

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11. INDIVIDUAL [***] BY [***]

  	
   

  	
  [***] <, [***]%

  [***] < [***]%

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  12.  [***] BY [***]

  	
   

  	
  >
  [***]%

  	
   

  	
  > [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.  TOTAL
  [***] BY [***]

  	
   

  	
  £ [***]%

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14.  INDIVIDUAL
  [***] BY [***]

  	
   

  	
  £ [***]%

  	
   

  	
  £ [***]%

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15. [***] BY [***]

  	
   

  	
  None

  	
   

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

  [***] ([***]%):

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

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £[***]

  	
  %

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  None

  	
   

  	
  [***]

  	
  £ [***]

  	
  %

  	
   

  	
   

  	
   

  	
   

  

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

18

 

	
   

  	
   

  	
  Product Number: [***]

  	
   

  	
   

  	
  SPECIFICATION

  
	
  BACHEM

  	
   

  	
   

  	
   

  	
   

  
	
   

  
	
  Effective Date:

  	
  Specification No.:
[***]

  	
   

  	
  Supersedes:
[***]

  	
  Page
  3 of 3

  
	
   

  
	
  Product
  Name:

  	
   

  	
   

  	
   

  	
  Manufacturing Approval:

  	
   

  	
  Date:

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   Exenatide
  (Exendin-4, AC2993)

  	
   

  	
   

  	
   

  	
  Quality Control Approval

  	
   

  	
  Date:

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Quality Assurance Approval

  	
   

  	
  Date:

  
										

 

	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17. [***]

  	
   

  	
  <
  [***] ppm

  	
   

  	
  None

  	
   

  	
  [***]
([***]

  [***])

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  18. [***]

  	
   

  	
  <
  [***]/mg

  	
   

  	
  None

  	
   

  	
  [***]

  ([***])

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  19. [***]

  	
   

  	
  Report
  results

  	
   

  	
  None

  	
   

  	
  ([***])

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  20. [***]

  	
   

  	
  Report
  results

  	
   

  	
  None

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  21. [***]

  	
   

  	
  Report
  results

  	
   

  	
  None

  	
   

  	
  ([***])

  	
   

  	
   

  	
   

  

 

Comments:

 

 

	
  Analyst:

  	
  [***]
  Date:

  
	
   

  	
   

  
	
  Verdict:

  	
   

  	
  By:

  	
   

  	
  Date:

  	
   

  	
   

  
	
   

  
	
  [***]
  Retest Interval: 

  	
   

  	
   

  	
  [***]
  Date: 

  	
   

  	
   

  
													

 

* CONFIDENTIAL TREATMENT REQUEST(ED)

 

19

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00069-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00069-of-00352.parquet"}]]