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EXHIBIT 10.44
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4),
200.83 AND 240.24b-2
AGREEMENT
THIS AGREEMENT is made by and among Ortho Biotech, a New Jersey
corporation, having a principal place of business at Xxxxx 000 Xxxxx, Xxxxxxx,
Xxx Xxxxxx 00000-0000 ("Ortho Biotech"), Amylin Pharmaceuticals, Inc., a
Delaware Corporation having a principal place of business at 0000 Xxxxx Xxxxxx
Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 ("Amylin") and Bachem California, a
California corporation, having a principal place of business at 0000 Xxxxxxx
Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000 ("Bachem"). References to any of Amylin or
Ortho Biotech, or Bachem includes reference to their respective Affiliates.
WHEREAS, Bachem previously manufactured for Amylin a compound referred
to as pramlintide (also known as AC-137).
WHEREAS, Amylin and LifeScan, Inc., an Affiliate of Ortho Biotech, have
entered in to a Collaboration Agreement dated June 20, 1995, under which they
are jointly developing and commercializing pramlintide.
WHEREAS, Ortho Biotech, on behalf of Xxxxxxx and Xxxxxxx, wishes to
engage Bachem to manufacture validation lots and commercial supplies of
pramlintide in connection with the joint development and commercialization of
pramlintide by Amylin and LifeScan, Inc., pursuant to the Collaboration
Agreement.
WHEREAS, Bachem now desires to manufacture for Ortho Biotech pramlintide
for use by Amylin and Ortho Biotech as validation batches for regulatory
registration in connection with pramlintide and to also produce for Ortho
Biotech commercial supplies of pramlintide; and
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NOW, THEREFORE, in consideration of the premises and the mutual
covenants and agreements contained herein, Bachem, Ortho Biotech 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.
1.2 "Commercial Lots" shall mean those lots described in Paragraph
2.2.
1.3 "Effective Date" means the later date of execution written on the
execution page of this Agreement.
1.4 "FDA" means the United States Food and Drug Administration and
any successor entity.
1.5 "Product" means the bulk form of pramlintide (also known as
AC--137) which meets the Product Specifications.
1.6 "Product Specifications" means the written specifications for
Product set forth in Exhibit 1 as amended from time to time pursuant to
Paragraph 3.1.
1.7 "Validation Lots" shall man those lots described in Paragraph
2.2.
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2. Purchase and Sale of Product
2.1 Bachem agrees to manufacture and supply to Ortho Biotech and Ortho
Biotech agrees to purchase a total of at least [...***...] of bulk Product
using the optimized process described in the Batch Production Records that
resulted from the production of the qualification batches under the Materials
Purchase Contract No. 151 dated September 24, 1996 between Amylin and Bachem.
Manufacture is to start in [...***...] and continue through the year
[...***...].
2.2 Bachem agrees to manufacture and supply the following quantities of
Product at the following times:
A total of [...***...] over the period [...***...] in
accordance with the schedule below:
VALIDATION LOTS
[...***...] [...***...] lots no later than [...***...]
COMMERCIAL LOTS
[...***...] [...***...] lots by [...***...] pursuant
to an issued Purchase Order.
[...***...] [...***...] lots at a rate of approximately
every [...***...] pursuant to an issued
Purchase Order.
3 * CONFIDENTIAL TREATMENT REQUESTED
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[...***...] [...***...] lots at a rate of approximately
every [...***...] in the year [...***...]
pursuant to AN issued Purchase Order.
Purchase Orders will be issued at least six months in advance of the delivery
date for the individual Purchase Orders.
2.3 The price for the Product shall be [...***...](gross weight)
F.O.B. Bachem's manufacturing facility in Torrance, California.
2.4 Ortho Biotech agrees to participate with Bachem in the investment
of [...***...] for plant and equipment needed to assure timely manufacture and
delivery of Product pursuant to this Agreement, with title to all improvements
and equipment to remain with Bachem. Total investment costs for Ortho Biotech is
[...***...] of which [...***...] has already been paid prior to the Effective
Date, of which [...***...] shall become due and payable within thirty (30) days
of the Effective Date of the Agreement and the remaining [...***...] shall be
due and payable in the second quarter of 1997 and no later than the end of the
second quarter. Bachem agrees to invest the remaining [...***...]. Such monies
will be used to make the specific plant investments and to purchase the
equipment listed in Exhibit 2 attached hereto. Bachem represents and warrants
that all investments listed in Exhibit 2 in the plant and equipment are
necessary to produce Product, will be used on a priority basis for manufacture
of the Product and will be used to manufacture the [...***...] quantities of
Product described in Paragraph 2.1. Bachem further represents and warrants that
no additional capital investment will be necessary on the part of Ortho Biotech
to enable Bachem to produce the specified quantities at the times specified in
Paragraph 2.2 and that Bachem shall make all other necessary capital investments
to timely produce and deliver the quantities of Product
4 * CONFIDENTIAL TREATMENT REQUESTED
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specified in Paragraph 2.2. Finally, Bachem represents and warrants that, after
the supply of the Validation Batches, a dedicated lab and production section
will be established and used for the supply of all Commercial Batches.
2.5 Any federal, state, county or 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 Ortho Biotech, provided evidence of such charge is provided to
Ortho Biotech in writing.
3. Manufacture of Product
3.1 Bachem shall promptly advise Ortho Biotech and Amylin of any
process changes proposed by Bachem for the manufacture of Product. 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 Ortho Biotech, Amylin and Bachem
have agreed to such changes in writing prior to adoption of modified Product
Specifications.
3.2 Bachem shall test or cause to be tested each lot of Product
before delivery as directed by Ortho Biotech. Each test shall set forth the
items tested, specifications and test results in a certificate of analysis for
each lot delivered to Ortho Biotech and Amylin under this Agreement. Bachem
shall send such certificate of analysis together with a certificate of
compliance to Ortho Biotech along with the delivery of Product. Ortho Biotech is
entitled to rely on such certificates for all purposes of this Agreement.
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3.3 Bachem shall permit Ortho Biotech and Amylin 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 of Product manufactured by Bachem so that Ortho Biotech
and/or Amylin 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.
3.4 Each party shall promptly advise the others of any safety or
toxicity problem of which such party becomes aware regarding the Product.
4. Acceptance of Product
4.1 Not later than 90 days after receipt of each shipment of Product
sold hereunder, Ortho Biotech shall test and examine such material for
compliance with the Product Specifications, any damage, defects or shortage. If
Ortho Biotech believes that any such shipment does not comply with the Product
Specifications or is otherwise deficient, Ortho Biotech shall promptly, but not
later than ninety (90) days after receipt of the shipment, notify Bachem and,
(if appropriate) send a sample of the shipment to Bachem. If Bachem is satisfied
that the relevant shipment does not comply with such specifications or is
deficient, Ortho Biotech shall dispose of the noncomplying shipment as Bachem
shall lawfully direct and at Bachem's sole cost and expense and Bachem shall
upon request from Ortho Biotech replace at Ortho Biotech's and Amylin's option
the shipment or remedy the deficiency promptly. If Bachem should deny that the
relevant shipment does not comply with such specifications or is deficient or
should admit such
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noncompliance or deficiency but deny that it is at fault, either Bachem or Ortho
Biotech may submit a sample of the relevant shipment and other relevant
information to an independent expert agreed upon by the parties, and the
decision of this independent expert shall be final and binding upon the parties.
The fees of such expert shall be borne by the losing party. Failure of Ortho
Biotech to notify Bachem of a claim, noncompliance or deficiency as set forth
herein shall constitute acceptance of such shipment.
4.2 If there is subsequently found to be a defect in any shipment of
Product, which could not reasonably be expected to have been found by diligent
and adequate inspection by Ortho Biotech pursuant to its obligation under this
article, (a "Hidden Defect"), Ortho Biotech and Bachem shall enter into
discussions in good faith as to the handling and disposal of the defective
consignment, having due regard to where responsibility for such defect lies.
5. Shipment and Delivery
5.1 Bachem shall prepare Product for shipment and arrange for
shipment of Product at a location designated in writing by Ortho Biotech.
Shipment terms are F.O.B. Bachem's manufacturing facility. All charges for
packing, hauling, storage, bar coding, and transportation to point of delivery
are included in the purchase price unless otherwise agreed to by the parties.
Bachem shall pay all delivery charges in excess of any delivery charges that
Ortho Biotech have agreed to pay herein. 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
xxxx of lading or other shipping receipt for each shipment in accordance with
Ortho Biotech' s instructions.
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5.2 Each delivery of Product shall be governed by the terms of this
Agreement, and none of the conflicting terms or conditions of Ortho Biotech's
purchase order form or Bachem's purchase order form, acknowledgment or invoice
form shall be applicable, except those specifying special shipping instructions
and invoice information.
6. Invoice
Bachem shall invoice Ortho Biotech with a single invoice upon
delivery of each lot of Product at an address to be specified by Ortho Biotech
in writing. Ortho Biotech shall pay Bachem net the earlier of ninety (90) days
from the date of their receipt of invoice or Ortho Biotech's acceptance of the
lot, provided the Product is not rejected as described in Paragraph 4.1.
7. Term and Termination
7.1 This Agreement shall commence on the Effective Date and shall
terminate on the date on which the last shipment of Product has been delivered,
accepted and paid for by Ortho Biotech, provided, however, that Paragraph 4.2
shall survive any such expiration of the Agreement.
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;
(b) Any party may terminate this Agreement by giving the other
parties thirty (30) days' prior written notice upon the breach of any material
provision of this Agreement by another party if the breach is not cured within
such ninety (90)day notice period. Failure to supply all quantities of Product
ordered on the
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dates specified in an issued Purchase Order shall be considered a material
breach.
(c) Ortho Biotech may terminate this Agreement by giving
Bachem thirty (30) days' prior written notice in each of the following
situations: (i) upon notice by the FDA that Bachem is not an approved commercial
supplier of Product or failure of Bachem to successfully complete its
Pre-Approval Inspection (PAI), (ii) the FDA notifies Amylin that it will not
approve the NDA directed to the Product or it is not approved by [...***...],
(iii) Amylin withdraws the NDA directed to the Product or (iv) Ortho Biotech
withdraws the Product from the market. If Ortho Biotech terminates this
Agreement under any of 7.2(c) (ii), (iii) or (iv), then Ortho Biotech agrees to
reimburse Bachem for a portion of its investment costs for plant and equipment,
as follows:
If Ortho Biotech has purchased less then [...***...] of Product
(including the Validation Batches), then Ortho Biotech will
reimburse Bachem for [...***...] of the investment costs,
If Ortho Biotech has purchased at least [...***...] but less then
[...***...] of Product (including the Validation Batches), then
Ortho Biotech will reimburse Bachem for [...***...] of the
investment costs.
If Ortho Biotech terminates this Agreement under any of
Paragraphs 7.2(c) (ii), (iii) or (iv), Ortho shall compensate Bachem for its
out-of-pocket costs associated with any work in progress.
9 * CONFIDENTIAL TREATMENT REQUESTED
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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.
8. Warranties
8.1 Bachem warrants that all Product delivered to Ortho Biotech and
pursuant to this Agreement will at the time of such delivery not be adulterated
or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as
amended, or within the meaning of any applicable state or municipal law in which
the definitions of adulteration or misbranding 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 and 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. Bachem further warrants that
Product delivered to Ortho Biotech pursuant to this Agreement shall conform when
delivered to the Product Specifications and shall be in compliance with
applicable laws and regulations. Bachem represents and warrants that it shall
comply with all present and future statutes, laws, ordinances and regulations
relating to the manufacture, assembly and supply of the Products being provided
hereunder, including, without limitation, those enforced by the United States
Food and Drug Administration (including compliance with current good
manufacturing practices). BACHEM MAKES NO OTHER WARRANTIES, EXPRESSED OR
IMPLIED, WITH RESPECT TO PRODUCT. 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.
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9. Indemnification
9.1 Ortho Biotech shall defend, indemnify and hold Bachem and its
Affiliates and their respective employees, servants and agents 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) Ortho Biotech's negligence or willful act or omission
in the testing, use, manufacture, promotion, marketing, sale, distribution,
packaging, labeling, handling, or storage of Product, or (ii) Ortho Biotech's
material breach of this Agreement.
9.2 Bachem shall defend, indemnify and hold Ortho Biotech and Amylin
and their Affiliates and their respective employees, servants and agents
harmless against any liability resulting from any third party claims made or
proceedings brought against Ortho Biotech and/or 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; (iii) Bachem's breach of any warranty set forth in Article 8 or
(iv) any infringement set forth in Paragraph 8.1.
9.3 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
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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.
10. Insurance
Bachem agrees to procure and maintain in full force and effect
during the term of this Agreement valid and collectible insurance policies in
connection with its activities as contemplated hereby. Upon Ortho Biotech's
request, Bachem shall provide to Ortho Biotech a certificate of coverage or
other written evidence reasonably satisfactory to Bachem of such insurance
coverage.
11. Confidential Information
Confidential Information will be as defined by and treated in
accordance with the Confidential Disclosure Agreement among Amylin, Xxxxxxx &
Xxxxxxx and Bachem dated September 1, 1995, a copy of which is attached hereto
as Exhibit 3, which shall remain in full force and effect during the term of
this Agreement.
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12. 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, a breakdown of machinery or equipment,
fire, flood, sabotage, shipwreck, embargo, strike, explosion, labor trouble,
accident, riot, act of governmental authority (including, without limitation,
acts relating to raw material or product allocation), acts of God, acts of war
and delays or failures in obtaining materials, supplies, equipment or
transportation. Quantities affected by a Force Majeure shall be eliminated from
this Agreement without liability.
In the event of a Force Majeure affecting Bachem, Bachem may prorate
and allocate manufacturing capacity (always with the understanding that Bachem
shall have a dedicated lab for the
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manufacture of Product for Ortho Biotech) among its Affiliates, its then current
contract customers and in such manner as may be deemed fair and reasonable based
upon purchases of products over the past year.
Notwithstanding the occurrence of a Force Majeure Event, if Bachem
shall be unable to supply Products in such quantities as Ortho Biotech shall
request and in compliance with the delivery periods set forth in this Agreement,
Ortho Biotech shall be permitted (with no obligation to Bachem) to obtain
Products from another source, and Ortho Biotech shall thereafter have no
obligation to purchase Products from Bachem until any contractual obligations
that Ortho Biotech has assumed in connection with obtaining a substitute supply
of Products shall have terminated. Ortho Biotech shall have no obligation to
affirmatively terminate any such contractual arrangements.
13. 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 to the following addresses of the respective
parties:
If to Ortho Biotech: Attn: Xxxxx X. Xxxxxxxx
Ortho Biotech
Xxxxx 000 Xxxxx
Xxxxxxx, XX 00000--0000
Telefax Number: (908) 526--4503
If to Amylin: Attn: Xxxxxxxx Xxxx
Amylin Pharmaceuticals, Inc.
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Telefax No.: (619) 552--2212
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If to Bachem: Bachem California
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Attn: Xxxx xx Xxxxxxxxx
Telefax No: 310/530--1571
14. 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.
15. Applicable Law
This Agreement shall be construed, interpreted and governed by the
laws of New York.
16. Alternative Dispute Resolution
Any controversy or claim arising out or relating to this Agreement,
or the breach thereof, shall be settled by the alternative dispute resolution
procedure described in Exhibit 4.
17. 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 or in the event of its merger or consolidation with another
company. 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
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such party then has hereunder. Notwithstanding the foregoing, Ortho Biotech may
assign this Agreement to Amylin and Amylin may assign this Agreement to Ortho
Biotech.
18. 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.
19. Severability
This Agreement is subject to the restrictions, limitations, terms
and conditions of all applicable governmental regulations, approvals and
clearances. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other term or provision
hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.
20. 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.
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21. 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.
22. Exhibits
All Exhibits referenced herein are hereby made a part of this
Agreement.
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.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives on the later date written
below.
ORTHO BIOTECH BACHEM CALIFORNIA
By: By Xxxxx Xxxxx
------------------------------- -------------------------------
Signature: /s/ XXXXX X. XXXXXXXX Signature: /s/ XXXXX XXXXX
------------------------ ------------------------
Title: V.P. Operations Title: Chairman of the Board
---------------------------- ---------------------------
Date: 7/1/97 Date: 7/2/97
----------------------------- -----------------------------
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Only as to the Provisions in which Amylin is specifically mentioned or that
relate to the supply of Validation lots.
AMYLIN PHARMACEUTICALS, INC.
By: X.X. Xxxxxx
-------------------------------
Signature: /s/ X.X. XXXXXX
------------------------
Title: VP of Product Dev.
----------------------------
Date: 2 Jul 97
-----------------------------
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EXHIBIT "1"
SPECIFICATIONS FOR CGMP PRAMLINTIDE
[...***...]
* CONFIDENTIAL TREATMENT REQUESTED
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APPENDIX I to EXHIBIT 1
Specifications for CGMP Pramlintide
[...***...]
* CONFIDENTIAL TREATMENT REQUESTED
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Exhibit 2
Capital Investments
[...***...]
* CONFIDENTIAL TREATMENT REQUESTED
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EXHIBIT 3
C O N F I D E N T I A L
CONFIDENTIAL DISCLOSURE AGREEMENT
THIS AGREEMENT is entered into as of September 1, 1995, by and
between AMYLIN PHARMACEUTICALS, INC., a Delaware corporation, having a place of
business at 0000 Xxxxx Xxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000
("AMYLIN"); BACHEM CALIFORNIA, a California corporation having a place of
business at 0000 Xxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000 ("BACHEM"); and
XXXXXXX & XXXXXXX, a New Jersey corporation having a place of business at Xxx
Xxxxxxx & Xxxxxxx Xxxxx, Xxx Xxxxxxxxx, Xxx Xxxxxx 00000 ("J&J"). The term "J&J"
also includes wholly owned subsidiaries of Xxxxxxx & Xxxxxxx.
RECITALS
WHEREAS, AMYLIN has made and continues to make developments
relating to: therapy and diagnosis of Type I and Type II diabetes mellitus and
other metabolic disorders, and compounds, procedures and processes related
thereto, including developments relating to pramlintide (AC-137);
WHEREAS, BACHEM has made and continues to make developments
relating to the manufacture and/or processing of pramlintide;
WHEREAS, J&J has made and continues to make developments relating
to the manufacture and processing of peptides;
WHEREAS, AMYLIN, BACHEM and J&J each desire to exchange certain
information relating to the developments made by each other in order to evaluate
their mutual interest therein;
WHEREAS each party appreciates that the other parties have
expended money and effort to establish a proprietary position with respect to
the developments they have made and that each party considers its developments
and information pertaining thereto to be its confidential property; and
WHEREAS AMYLIN, BACHEM and J&J are willing to reveal to one other
certain information relating to these developments on a confidential basis:
NOW, THEREFORE, in consideration of the foregoing, and of the
mutual covenants, terms and conditions hereinafter expressed, AMYLIN, BACHEM and
J&J agree as follows:
1. "Confidential Information" shall mean information relating to
the above-captioned developments including, where appropriate and without
limitation, any information, patent disclosures, patent applications,
structures, models, techniques, processes, compositions, compounds and
apparatuses relating to
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Confidential Disclosure Agreement CONFIDENTIAL
AMYLIN PHARMACEUTICALS, INC.,
BACHEM CALIFORNIA and
XXXXXXX & XXXXXXX
September 1, 1995
the same disclosed by AMYLIN, BACHEM or J&J to another party to this Agreement
("Recipient") or obtained by Recipient through observation or examination of
information or developments, but only to the extent that such information is
maintained as confidential by AMYLIN, BACHEM or J&J, respectively, and is
identified or marked as "confidential." To be considered "Confidential
Information" under this Agreement, information disclosed in writing must be
marked confidential and information disclosed in other forms (for example orally
or visually) must be summarized in writing and marked "confidential" and
provided by the disclosing party to the Recipient within a reasonable time after
initial disclosure.
2. The parties each agree to disclose Confidential Information to
the other(s), which, in each of their sole discretion, is reasonably necessary
to permit the other(s) to evaluate their interest as described above.
3. The parties each agree that the other parties are the owners
of their respective Confidential Information and that they will not disclose any
other party's Confidential Information to third parties, and agree not to use
any other party's Confidential Information at any time except for the purposes
of evaluation noted above; provided, however, AMYLIN, BACHEM and J&J shall have
no liability to one other with respect to use or disclosure to others not
parties to this Agreement of such information as Recipient can establish by
written documentation to:
a. have been publicly known prior to disclosure of such
information by AMYLIN, BACHEM or J&J to Recipient; or
b. have become publicly known, without fault on the part of
Recipient, subsequent to disclosure of such information to
Recipient; or
c. have been otherwise known by Recipient prior to
communication by AMYLIN, BACHEM or J&J to Recipient of such
information; or
d. have been received by Recipient at any time from a source
other than AMYLIN, BACHEM or J&J, lawfully having possession
of such information who is under no obligation to any other
party with respect to such information at the time of
disclosure.
4. AMYLIN, BACHEM and J&J each agree that any disclosure of the
Confidential Information within their
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Confidential Disclosure Agreement CONFIDENTIAL
AMYLIN PHARMACEUTICALS, INC.,
BACHEM CALIFORNIA and
XXXXXXX & XXXXXXX
September 1, 1995
organizations will only be such as is reasonably necessary to their evaluation
and will only be to such employees who are bound by written agreements with
AMYLIN, BACHEM, or J&J, respectively, to maintain the Confidential Information
in confidence.
5. Recipient agrees to promptly return all tangible items
relating to the Confidential Information of AMYLIN, BACHEM and/or J&J, including
all written materials, photographs, models, compounds, compositions and the like
made available or supplied to Recipient, and all copies thereof, upon the
request of the party who supplied the Confidential Information (except for a
single copy thereof which may be retained in the legal files of Recipient for
the sole purpose of determining the scope of the obligations incurred under this
Agreement). Upon request of the party who supplied the Confidential Information,
Recipient further agrees to identify those persons to whom the Confidential
Information that is the subject of this Agreement was disclosed.
6. In the event that Recipient is requested or is required by
deposition, interrogatories, requests for information, documents or admissions,
subpoenas, civil investigative demands or similar process, to disclose any
Confidential Information provided by AMYLIN, BACHEM or J&J, it is agreed that
Recipient will provide AMYLIN, BACHEM or J&J, respectively, with a notice of
such request(s) immediately, but in no event later than two (2) business days
after receipt of such request, so that AMYLIN, BACHEM or J&J, respectively, may
seek an appropriate protective order and/or waive Recipient's obligation to
comply with the requirements of Section 3 hereof. It is further agreed that if,
in the absence of either a protective order or the receipt of a waiver
hereunder, within two (2) business days prior to the time Recipient is required
to disclose Confidential Information or else stand liable for contempt or suffer
other censure or penalty, Recipient may disclose such Confidential Information
without liability under Section 3. AMYLIN, BACHEM or J&J, respectively, and
Recipient will fully cooperate with each other in connection with efforts to
obtain any such order or other remedy.
7. This Agreement shall not be construed to grant any license or
other rights except as specified herein.
8. The obligations of each party under this Agreement shall
continue for a period of five (5) years from the date of disclosure.
9. This Agreement may not be assigned by any party.
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Confidential Disclosure Agreement CONFIDENTIAL
AMYLIN PHARMACEUTICALS, INC.,
BACHEM CALIFORNIA and
XXXXXXX & XXXXXXX
September 1, 1995
10. AMYLIN, BACHEM and J&J each warrant that they believe
themselves to be the owners of the Confidential Information supplied by them,
but make no other warranty relating to the Confidential Information or the use
to be made thereof by Recipient, and disclaim all implied warranties.
11. Each party's evaluation of Confidential Information shall be
at its own risk and each party agrees to hold harmless and to indemnify the
other parties against any and all claims, judgments, costs, awards, expenses
(including reasonable attorneys' fees), and liabilities of every kind arising
from any use made of Confidential Information received from another party.
12. No party shall be permitted to use the name of another party
in any publicity, advertising or public announcement concerning this Agreement
or the subject matter hereof without the prior express written consent of the
other party.
13. This Agreement sets forth the entire agreement between the
parties relating to the subject matter of this Agreement, and fully supersedes
any and all prior and contemporaneous agreements or understandings between the
parties pertaining to the subject matter hereof.
14. This Agreement may not be amended, supplemented or otherwise
modified except by an instrument in writing signed by all parties.
15. The failure of any party to insist upon strict performance of
any provision of this Agreement or to exercise any right hereunder shall not
constitute a waiver of that provision of or right under this Agreement or of any
other provision of or right under this Agreement.
16. If any provision of this Agreement is declared invalid,
illegal or unenforceable, such provision shall be severed and all remaining
provisions shall continue in full force and effect.
17. This Agreement shall be construed and enforced in accordance
with the laws of the State of California (except its choice of law rules), and
the parties hereby submit to the jurisdiction and venue of the California
courts, both state and federal.
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Confidential Disclosure Agreement CONFIDENTIAL
AMYLIN PHARMACEUTICALS, INC.,
BACHEM CALIFORNIA and
XXXXXXX & XXXXXXX
September 1, 1995
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed in triplicate counterpart original by their duly authorized
representatives as of the day and year above written. Any and all Confidential
Information disclosed prior to the effective date of this Agreement shall be
deemed to fall within the scope of this Agreement.
AGREED AND ACCEPTED: AGREED AND ACCEPTED:
AMYLIN BACHEM
AMYLIN PHARMACEUTICALS, INC. BACHEM CALIFORNIA
By:____________________________ By:___________________________________
Xxxxxxxx X. Xxxx, Esq. (signature)
Vice President and
General Counsel Name:_________________________________
(type or print)
Title:________________________________
AGREED AND ACCEPTED:
J&J
Xxxxxxx & Xxxxxxx
By:____________________________
(Signature)
Name:__________________________
(type or print)
Title:_________________________
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Exhibit 4
Alternative Dispute Resolution
The parties recognize that a bona fide dispute as to certain matters may
arise from time to time during the term of this Agreement which relates to
either party's rights and/or obligations. To have such a dispute resolved by
this Alternative Dispute Resolution ("ADR") provision, a party first must send
written notice of the dispute to the other party for attempted resolution by
good faith negotiations between their respective presidents (or their
equivalents) of the affected subsidiaries, divisions, or business units within
twenty-eight (28) days after such notice is received (all references to "days"
in this ADR provision are to calendar days).
If the matter has not been resolved within twenty-eight (28) days of the
notice of dispute, or if the parties fail to meet within such twenty-eight (28)
days, either party may initiate an ADR proceeding s provided herein. The parties
shall have the right to be represented by counsel in such a proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to
the other party of the issues to be resolved by ADR. Within fourteen (14) days
after its receipt of such notice, the other party may, by written notice to the
party initiating the ADR, add additional issues to be resolved within the same
ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to preside in the
resolution of any disputes in this ADR proceeding. If the parties are unable to
agree on a mutually acceptable neutral within such period, either party may
request the President of the CPR Institute for Dispute Resolution ("CPR"), 000
Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, or its
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successor organization or, if neither exists a similar type organization to
select a neutral pursuant to the following procedures--
(a) The CPR shall submit to the parties a list of not less than
five (5) candidates within fourteen (14) days after receipt of the request,
along with a Curriculum Vitae for each candidate. No candidate shall be an
employee, director, or shareholder of either party or any of their subsidiaries
or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her impartiality.
(c) Each party shall number the candidates in order of
preference (with the number one (1) signifying the greatest preference) and
shall deliver the list to the CPR within seven (7) days following receipt of the
list of candidates. If a party believes a conflict of interest exists regarding
any of the candidates, that party shall provide a written explanation of the
conflict to the CPR along with its list showinq its order of preference for the
candidates. Any party failing to return a list of preferences on time shall be
deemed to have no order of preference.
(d) If the parties collectively have identified fewer than three
(3) candidates deemed to have conflicts, the CPR immediately shall designate as
the neutral the candidate for whom the parties collectively have indicated the
greatest preference. If a tie should result between two candidates, the CPR may
designate either candidate. If the parties collectively have identified three
(3) or more candidates deemed to have conflicts, the CPR shall review the
explanations regarding conflicts and, in its sole discretion, may either (1)
immediately designate as
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the neutral the candidate for whom the parties collectively have indicated the
greatest preference, or (ii) issue a new list of not less than five (5)
candidates, in which case the procedures set forth in Sections 2(a) - 2(d) shall
be repeated.
3. No earlier than twenty-eight (28) days or later than fifty--six (56)
days after selection, the neutral shall hold a hearing to resolve each of the
issues identified by the parties. The ADR proceeding shall take place at a
location agreed upon by the parties. If the parties cannot agree, the neutral
shall designate a location other than the principal place of business of either
party or any of their subsidiaries or affiliates.
4. At least seven (7) days prior to the hearing, each party shall submit
the following to the other party and the neutral:
a) a copy of all exhibits on which such party intends to rely in
any oral or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together
with a request for a specific damage award or other remedy for each issue. The
proposed rulings and remedies shall not contain any recitation of the facts or
any legal arguments and shall not exceed one (1) page per issue.
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20) pages with at
least 12 point type, courier font and margins not less than 1 inch top, bottom
and sides. This page limitation shall apply regardless of the number of issues
raised in the ADR proceeding.
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Depositions shall be limited to 3 depositions per party with each
deposition not to exceed 10 hours. Interrogatories shall be limited to 10
questions (including all subparts to questions) for each party. Production of
documents shall be limited to the extent the neutral in his/her sole discretion
feels is reasonable and necessary. No other discovery shall be permitted unless
authorized by the neutral.
5. The hearing shall be conducted on four (4) consecutive days or less
and shall be governed by the following rules:
(a) Each party shall be entitled to twelve (12) hours of hearing
time to present its case. The neutral shall determine whether each party has had
the twelve (12) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony, documents or other
evidence, to cross-examine witnesses, and to make a closing argument.
Cross--examination of witnesses shall occur immediately after their direct
testimony, and cross-examination time shall be charged against the party
conducting the cross--examination;
(c) The party initiating the ADR shall begin the hearing and, if
it chooses to make an opening statement, shall address not only issues it raised
but also any issues raised by the responding party. The responding party, if it
chooses to make an opening statement, also shall address all issues raised in
the ADR. Thereafter, the presentation of regular and rebuttal testimony and
documents, other evidence, and closing arguments shall proceed in the same
sequence;
(d) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances.
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Affidavits prepared for purposes of the ADR hearing also shall, however, be
admissible. As to the admission of evidence, the neutral shall apply the Federal
Rules of Evidence to evidentiary issues and shall have the sole discretion
regarding the admissibility of evidence according to the Federal Rules of
Evidence.
6. Within seven (7) days following completion of the hearing, each party
may submit to the other party and the neutral a post-hearing brief in support of
its proposed rulings and remedies, provided that such brief shall not contain or
discuss any new evidence and shall not exceed ten (10) pages with the same
requirements as specified in 4(d) herein. This page limitation shall apply
regardless of the number of issues raised in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14)
days following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each disputed
issue but may adopt one party's proposed rulings and remedies on some issues and
the other party's proposed rulings and remedies on other issues. The neutral
shall not issue any written opinion or otherwise explain the basis of the
ruling.
8. The neutral is empowered to award any remedy allowed by law,
including money damages, prejudqement interest and attorneys fees, and to grant
final, complete, interim, or interlocutory relief, including injunctive relief.
Notwithstanding the foregoing, punitive or treble damages may not be awarded.
9. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees
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and expenses of the prevailing party (including all expert witness fees and
expenses), the fees and expenses of a court reporter, and any expenses for a
hearing room, shall be paid as follows:
(a) If the neutral rules in favor of one party on all disputed
issues in the ADR, the losing party shall pay one hundred percent (100%) of such
fees and expenses.
(b) If the neutral rules in favor of one party on some issues
and the other party on other issues, the neutral shall issue with the rulings a
written determination as to how such fees and expenses shall be allocated
between the parties. The neutral shall allocate fees and expenses in-a way that
bears a reasonable relationship to the outcome of the ADR, with the party
prevailing on more issues, or on issues of greater value or gravity, recovering
a relatively larger share of its legal fees and expenses.
10. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non--appealable, and may be entered as a
final judgment in any court having jurisdiction,
11. Except as required by law, the existence of the dispute, any
settlement negotiations, the ADR hearing, any submissions (including exhibits,
testimony, proposed rulings, and briefs), and the ruling shall be deemed
Confidential Information. The neutral shall have the authority to impose
sanctions for unauthorized disclosure of Confidential Information.
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