Exhibit 10.2
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 406 of the Securities Act of 1933, as amended. The omitted
portions of this exhibit have been filed separately with the Securities and
Exchange Commission.
COLLABORATION AND GLOBAL SUPPLY AGREEMENT
By and Between
IMMUNEX CORPORATION
and
AMERICAN HOME PRODUCTS CORPORATION acting through its
WYETH-AYERST PHARMACEUTICALS division
COLLABORATION AND GLOBAL SUPPLY AGREEMENT
This COLLABORATION AND GLOBAL SUPPLY AGREEMENT (the "Agreement") is entered into
this 6th day of November, 2001 (the "Effective Date"), by and between IMMUNEX
CORPORATION, a Washington corporation having its principal place of business at
00 Xxxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000, together with its Affiliates
(collectively, "Immunex") and AMERICAN HOME PRODUCTS CORPORATION, a Delaware
corporation having its corporate headquarters at Five Xxxxxxx Xxxxx, Xxxxxxx,
Xxx Xxxxxx 00000, together with its Affiliates (collectively, "AHPC"), acting
through its WYETH-AYERST PHARMACEUTICALS division, having offices at 000 Xxxx
Xxxxxxxxx Xxxxxx, Xx. Xxxxxx, Xxxxxxxxxxxx 00000, together with its Affiliates
(collectively, "Wyeth").
Background
WHEREAS, Immunex and AHPC entered into a TNFR License and Development Agreement
dated July 1, 1996 (the "TNFR Agreement"), in which they agreed to collaborate
as set forth in the TNFR Agreement with regard to Enbrel(R) (etanercept)
("Enbrel"), a biopharmaceutical product for the treatment of rheumatoid
arthritis and other diseases;
WHEREAS, in the TNFR Agreement, the Parties agreed that Immunex would have
certain rights to market and sell Enbrel in the United States, its territories
and possessions (including Puerto Rico), and Canada, and that Wyeth would have
certain rights to market and sell Enbrel in all other countries;
WHEREAS, Immunex and AHPC entered into a Promotion Agreement dated September 25,
1997, regarding the marketing and promotion of Enbrel in the Immunex Territory
(the "Promotion Agreement");
WHEREAS, Immunex and AHPC entered into an Enbrel Supply Agreement with
Boehringer Ingelheim Pharma KG (including any successor thereto, "BIP") dated
November 5, 1998, which agreement was amended by Amendment No. 1 to the Enbrel
Supply Agreement dated June 27, 2000, in which BIP agreed to manufacture certain
quantities of Enbrel and supply those quantities to Immunex and Wyeth;
WHEREAS, Greenwich Holdings, Inc. ("Greenwich"), a wholly-owned subsidiary of
AHP Subsidiary Holding Corporation ("AHPS"), a wholly-owned subsidiary of AHPC,
owns a manufacturing facility located in West Greenwich, Rhode Island at which
Enbrel is expected to be manufactured;
WHEREAS, Immunex, AHPC, and AHPS have entered into a Purchase Agreement
simultaneously with this Agreement, pursuant to which AHPS is obligated to sell,
and Immunex is obligated to purchase, the shares of Greenwich;
WHEREAS, AHP Manufacturing B.V., a wholly-owned indirect subsidiary of AHPC,
through its Wyeth Medica Ireland branch, is in the process of constructing a
manufacturing facility in Ireland, at which it plans to manufacture Enbrel,
among other products;
WHEREAS, the Parties entered into a letter agreement regarding the short-term
allocation of Enbrel supplies dated August 9, 2000 (the "Short-Term Allocation
Agreement"), which agreement is attached hereto as Exhibit C;
WHEREAS, the Parties agreed, in a Memorandum of Understanding Regarding
Long-Term Allocation of ENBREL Supplies dated August 9, 2000, as amended on
April 18, 2001 (the "MOU"), to enter into a Collaboration Agreement regarding
the manufacture, inventory, and allocation of supplies of Enbrel throughout the
world, which MOU is superceded by this Agreement and is of no further force and
effect; and
WHEREAS, the Parties now wish to set forth their mutual agreements concerning
the manufacture, supply, inventory, and allocation of supplies of Enbrel
throughout the world.
NOW THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties do hereby agree as follows:
Article 1. Definitions
The following terms, whether used in the singular or the plural, shall have the
meaning assigned to them below for purposes of this Agreement.
1.1 "Affiliate" shall mean: (a) any corporation or business entity of which a
Party owns, directly or indirectly, fifty percent (50%) or more of the
assets or outstanding stock; (b) any corporation, or business entity which
a Party directly or indirectly controls; (c) any corporation or business
entity that is under common control with a Party; (d) any corporation or
business entity that owns, directly or indirectly, fifty percent (50%) or
more of the assets or outstanding stock of a Party; or (e) any corporation
or business entity that directly or indirectly controls a Party. For the
purposes of this Agreement, neither Party shall be considered to be an
Affiliate of the other Party, even if a Party owns, directly or
indirectly, fifty (50%) or more of the assets or outstanding stock of the
other Party, directly or indirectly controls the other Party, or is under
common control with the other Party.
1.2 "Allocable Overhead" shall mean costs allocated to the manufacture of Bulk
Drug Substance based on methodology consistently applied in the project
accounting system and determined in accordance with GAAP. Allocable
Overhead shall include:
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(i) indirect labor, benefits and taxes, indirect supplies, outside
laboratory services, laboratory and plant consumables, and other
indirect department expenses;
(ii) facility costs such as rent, depreciation (excluding depreciation of
capitalized interest), utilities, facility repair and maintenance
and monitoring;
(iii) other overhead costs, including infrastructure services, purchasing,
information systems, accounting, period costs, and other related
expenses; and
(iv) such other costs as the Parties may agree upon in writing from time
to time.
An example of the methodology to be used in calculating Allocable Overhead
is included in Exhibit A attached hereto. Allocable Overhead shall not
include any costs attributable to general corporate activities, including
but not limited to executive management, investor relations, business
development, legal affairs, and finance.
1.3 "BIOS Capacity" shall mean the volume of Bulk Drug Substance that the
Parties reasonably expect to be manufactured within bioreactors having a
working volume equivalent to the RI Capacity during a Calendar Year.
1.4 "BIOS Site" shall mean the portion of the biopharmaceutical manufacturing
facility to be built at the Wyeth BioPharma campus at Grange Castle
International Business Park, Clondalkin, Xxxxxx 00, Xxxxxxx, within which
the BIOS Capacity will be manufactured. The BIOS Site shall not include
such manufacturing facility with respect to its manufacture of Excluded
Supply or products other than the Product.
1.5 "BIP Capacity" shall mean the volume of Bulk Drug Substance that Immunex
and Wyeth reasonably expect to purchase collectively from BIP pursuant to
the Enbrel Supply Agreement during a Calendar Year, excluding any Bulk
Drug Substance from Bulk Drug Substance Runs that have been separately
negotiated pursuant to an agreement between only one of the Parties hereto
and a Third Party customer of BIP on or before March 26, 2001.
1.6 "BIP Site" shall mean that portion of BIP's facility at Birkendorfer
Stra(beta)e 65, 88397 Biberach an der Riss, Federal Republic of Germany,
within which the BIP Capacity is or will be manufactured, including but
not limited to the [*], during a Calendar Year. In the event that the
manufacture of the Product is transferred to another facility of BIP, a
BIP Affiliate, or a successor of BIP in accordance with the terms of the
Enbrel Supply Agreement, then the BIP Site shall refer to that portion of
such successor facility in which the BIP Capacity is manufactured.
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1.7 "Blended Price" shall mean the price for Bulk Drug Substance that is
calculated as [*] for each of the Sites for a Calendar Year, as further
described in Section 9.3 below. An example of the calculation of the
Blended Price is set forth on Exhibit A attached hereto.
1.8 "Bulk Drug Substance" shall mean etanercept that has been processed to
result in bulk drug substance and purified to a concentrated form, and
that can be stored in liquid or frozen form under appropriate conditions.
1.9 "Bulk Drug Substance Lot" shall mean a single lot of Bulk Drug Substance,
produced at a fermentation scale of [*], or any other scale mutually
agreed by the Parties.
1.10 "Bulk Drug Substance Run" shall mean a single run of the process for
manufacturing a Bulk Drug Substance Lot.
1.11 "Calendar Quarter" shall mean a three (3)-month period commencing on the
first day of January, April, July, and October of each Calendar Year
during the Term.
1.12 "Calendar Year" shall mean a twelve (12)-month period beginning on January
1 of each year during the Term.
1.13 "Catalytica Supply Agreement" shall mean the Supply Agreement, dated
October 16, 2000, among Immunex, Wyeth, and Catalytica Pharmaceuticals,
Inc. (including any successor thereto, "Catalytica").
1.14 "cGMP" shall mean the regulatory requirements for current good
manufacturing practices promulgated by the FDA under the FD&C Act, 21
C.F.R.ss.210 et seq., and under the PHS Act, Biological Products, 21
C.F.R.ss.ss.600-610, or the applicable regulatory guidance documents
promulgated by the EMEA or Koseisho, as the same may be amended from time
to time.
1.15 "Collaboration" shall mean the collaborative efforts of the Parties as
further described herein.
1.16 "Confidential Information" shall mean all proprietary and confidential
information of a Party, including, without limitation, trade secrets,
technical information, business information, sales information, customer
and potential customer lists and identities, product sales plans, license
and sublicense agreements, inventions, developments, discoveries,
know-how, methods, techniques, formulae, data, processes, and other
proprietary ideas, whether or not protectable under patent, trademark,
copyright, or other legal principles, that the other Party has access to
or receives, but does not include information that (a) is or becomes
publicly available through no fault of the receiving Party; (b) was
already known to the receiving Party at the time it was disclosed to the
receiving Party, as shown in the records of the receiving Party maintained
during the ordinary course of business; (c) is independently developed by
employees of the
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receiving Party who had no knowledge of or access to such information, as
shown in the records of the receiving Party maintained in the ordinary
course of business; or (d) is received from a Third Party who is under no
obligation of confidentiality to the disclosing Party. As used herein,
"Confidential Information" shall include, without limitation, any and all
technical information regarding the Product, Five-Year Requirement
Schedules, Five-Year Capacity Projections, and Five-Year Plans.
1.17 "Direct Costs" shall include: (a) direct labor costs, which shall include
all wages directly attributable and allocable to labor for the production
of Bulk Drug Substance at the RI Site and the BIOS Site, as applicable;
and (b) material costs, including the costs of acquiring all materials
directly attributable and allocable to the production of Bulk Drug
Substance at the RI Site and the BIOS Site, as applicable.
1.18 "Drug Product" shall mean Bulk Drug Substance that has been appropriately
formulated, compounded, filled into containers and lyophilized (if
applicable), but is not labeled (i.e., unlabeled vial or syringe packed in
a labeled secondary shipper).
1.19 "EMEA" shall mean the European Medicines Evaluation Agency, or any
successor agency.
1.20 "Enbrel Supply Agreement" shall mean the November 5, 1998 agreement among
Immunex, BIP, and AHPC for the manufacture of Product at the BIP Facility,
as amended on June 27, 2000 and as may be amended from time to time by the
parties thereto.
1.21 "European Union" shall mean those countries within the jurisdiction of the
EMEA.
1.22 "Excluded Supply" shall mean (a) any quantities of Product manufactured or
acquired by Immunex outside of the RI Capacity or BIP Capacity, and (b)
any quantities of Product manufactured or acquired by Wyeth outside of the
BIOS Capacity or the BIP Capacity.
1.23 "FDA" shall mean the United States ("U.S.") Food and Drug Administration,
or any successor agency.
1.24 "Finished Product" shall mean Drug Product in a vial or syringe that has
been appropriately labeled and that is suitable for shipment in bulk
packaging to Immunex, Wyeth and/or their respective designee(s) for final
commercial packaging and conversion to Product Supply.
1.25 "Fully Absorbed Manufacturing Cost" shall have the meanings set forth
below:
(a) For Bulk Drug Substance manufactured at the RI Site or the BIOS
Site, Fully Absorbed Manufacturing Cost shall mean [*] of all costs,
expenses, and period costs incurred at the Site for the
manufacturing of Bulk Drug Substance
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incurred by the Party controlling such Site, determined according to
GAAP and as mutually agreed upon by the Parties. Such costs shall
include Direct Costs and Allocable Overhead at each stage of the
process for manufacturing Bulk Drug Substance at such Site. Fully
Absorbed Manufacturing Cost shall also include any other costs borne
by the Party controlling such Site for transport, customs clearance
and storage of Bulk Drug Substance (if necessary) at the request of
another Party or a Third Party (i.e., freight, customs duty, and
transportation related insurance). Fully Absorbed Manufacturing Cost
shall exclude any losses at the RI Site or BIOS Site resulting from
a significant or catastrophic event that would otherwise be covered
by property insurance, regardless of whether such insurance is in
place. To the extent that the manufacturing capacity at the RI Site
or BIOS Site is utilized to manufacture a product other than the
Product, the Direct Costs and Allocable Overhead incurred for the
manufacture of such other product shall be excluded from the
calculation of Fully Absorbed Manufacturing Cost.
(b) For Bulk Drug Substance manufactured at the BIP Site, Fully Absorbed
Manufacturing Cost shall mean the amount paid or payable by a Party
to BIP for Bulk Drug Substance purchased by a Party under the Enbrel
Supply Agreement, whether purchased in the form of Bulk Drug
Substance itself or as incorporated into Drug Product or Finished
Product, as the case may be.
An example of the calculation of Fully Absorbed Manufacturing Cost is
included in Exhibit A attached hereto.
1.26 "GAAP" shall mean U.S. Generally Accepted Accounting Principles
consistently applied.
1.27 [*]
1.28 [*]
1.29 "Immunex Territory" shall mean the U.S., its territories and possessions
(including Puerto Rico) and Canada.
1.30 "Inventory Carrying Costs" shall mean [*] per annum of the Fully Absorbed
Manufacturing Cost of Bulk Drug Substance manufactured at either the RI
Site or the BIOS Site, as applicable, and held in storage by or on behalf
of a Party for a period greater than [*] days after release by both
Parties, commencing after such [*]-day period has elapsed.
1.31 [*] shall mean the Immunex proprietary process for manufacturing Bulk Drug
Substance, which, if used at the RI Site, shall include the [*], and which
process is the subject of a letter agreement among Immunex, Wyeth, and BIP
dated May 29, 2001.
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1.32 "Major Markets" shall mean the U.S., the European Union, and Japan.
1.33 "Manufacturing Process" shall mean a process for manufacturing Bulk Drug
Substance and/or Drug Product, including but not limited to the T1
Process, the [*], and the T2 Process.
1.34 "Party" or "Parties" shall refer to Immunex, AHPC, and/or Wyeth, as
applicable.
1.35 "Phase A Capacity" shall mean the volume of Bulk Drug Substance that the
Parties reasonably expect to be manufactured within the [*] liter nominal
volume bioreactors contained in the Phase A Facility during a Calendar
Year, or, if Immunex transfers such manufacturing to the Phase B Facility,
the volume of Bulk Drug Substance that the Parties reasonably expect to be
manufactured within bioreactors of equivalent working volume in the Phase
B Facility during a Calendar Year.
1.36 "Phase A Facility" shall mean the manufacturing plant at the RI Site that
Wyeth is currently in the process of retrofitting to manufacture Bulk Drug
Substance.
1.37 "Phase B Additional Capacity" shall mean the volume of Bulk Drug Substance
that the Parties reasonably expect to be manufactured within [*] liter
nominal volume bioreactors in the Phase B Facility per Calendar Year.
1.38 "Phase B Facility" shall mean the new manufacturing facility that Immunex
plans to construct located on the portion of the RI Site that Immunex
Manufacturing Corporation has leased from Greenwich pursuant to the Ground
Lease between those parties dated March 9, 2001.
1.39 "Product" shall mean the pharmaceutical product etanercept, in any form.
1.40 "Product Supply" shall mean Finished Product that has been fully packaged
and is in final form for distribution for commercial sale or clinical
testing in any country in the Immunex Territory or the Wyeth Territory.
1.41 "Product Supply Units" shall refer to individual units of Product Supply.
1.42 "Production Surplus" shall mean the situation, as may be determined by the
JSC from time to time, in which the Parties' forecasted needs for Product
Supply in any Calendar Year fall more than [*] below the total quantity of
Bulk Drug Substance that can be manufactured in the Subject Capacity
during such Calendar Year.
1.43 "Quality Agreement" shall mean the Quality Agreement attached hereto as
Exhibit D, as the same may be amended from time to time, setting forth the
terms and conditions relating to (a) the quality, safety, efficacy, and
purity of the Bulk Drug Substance supplied by each Party to the other
hereunder, (b) the respective roles and
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responsibilities of Immunex and Wyeth relating to quality control, quality
assurance, validation, ongoing manufacturing, materials, standards, and
the functions of person(s)-in-the-plant, and (c) procedures for resolving
disputes regarding any of the foregoing.
1.44 "Regulatory Authority" shall mean (a) the applicable government agency or
agencies in a country whose permission, approval, or clearance must be
obtained for, or which has jurisdiction over, the manufacturing,
production, clinical testing, and/or marketing of the Product, including,
but not limited to, the FDA, the EMEA, and Koseisho; and (b) any state,
provincial, or local government agency or entity with jurisdiction, to any
extent, over the Party supplying the Product, a Site, or the Product.
1.45 "Regulatory Filings" shall mean all documents and other information filed
with and/or submitted to one or more Regulatory Authorities and which are
related to the Product.
1.46 "Regulatory Requirements" shall mean (a) all Specifications, methods of
manufacture, and other information in one or more Regulatory Filings in a
Major Market related in any way to the Product, and (b) all laws, rules,
regulations, applicable regulatory guidance documents, and other
requirements of any Regulatory Authority in a Major Market that govern the
Product, the manufacture of the Product, and use of the Product in or with
Finished Products, including, but not limited to, the requirements set
forth in the United States Federal Food, Drug, and Cosmetic Act (the "FD&C
Act"), 21 U.S.C. Section 301 et seq., the Public Health Service Act (the
"PHS Act"), 42 U.S.C. Section 262 et seq., cGMPs, any applicable
regulations promulgated by the EMEA, and any applicable regulations
promulgated by Koseisho, as the same may be amended from time to time.
1.47 "Released Bulk Drug Substance" shall mean, with respect to a particular
Site and a particular Calendar Year, Bulk Drug Substance that is, or is
expected to be, released at such Site during such Calendar Year, including
(a) any such Bulk Drug Substance for which manufacturing was commenced and
completed and which was released during such Calendar Year, and (b) any
such Bulk Drug Substance released during such Calendar Year that was Work
In Process at the end of the prior Calendar Year.
1.48 "RI Capacity" shall mean the volume of Bulk Drug Substance that the
Parties reasonably expect to be manufactured from the combined capacity of
the Phase A Capacity and the Phase B Additional Capacity in a Calendar
Year.
1.49 "RI Site" shall mean the portion of the biopharmaceutical manufacturing
facility in West Greenwich, Rhode Island, currently owned by Greenwich,
within which the RI Capacity is or will be manufactured. The RI Site shall
not include such manufacturing facility with respect to its manufacture of
Excluded Supply or products other than the Product.
1.50 "Safety Agreement" means the Memorandum of Understanding between Immunex
Drug Safety Surveillance and Wyeth-Ayerst for the Identification,
Collection, Evaluation and Regulatory Reporting of Adverse Events and
Product Quality and for
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the Provision of Medical Information for Enbrel(R) (etanercept), effective
as of December 13, 2000, as the same may be amended from time to time.
1.51 "Site" shall mean the BIOS Site, the BIP Site, and/or the RI Site, as
applicable.
1.52 "Specifications" shall mean a set of specifications for Bulk Drug
Substance agreed upon by the Parties pursuant to the Quality Agreement.
1.53 "Subject Capacity" shall mean that manufacturing capacity subject to the
Collaboration as further set forth in Section 2.2 below.
1.54 "Supply Shortage" shall mean the situation, as may be determined by the
JSC from time to time, that in [*] of a Five-Year Plan approved by the
JSC, the total quantity of Bulk Drug Substance that can be manufactured in
the Subject Capacity is less than [*]. When a Supply Shortage is in
effect, it shall be deemed to be in effect for the [*].
1.55 "T1 Process" shall mean the Immunex proprietary Manufacturing Process used
by BIP as of the Effective Date to manufacture Bulk Drug Substance.
1.56 "T2 Process" shall mean the Immunex proprietary process for manufacturing
Bulk Drug Substance, which process is currently the subject of the T2
Development Agreement: TNFR:FC Process (Phase I), dated January 1, 1999,
among Immunex, AHPC, and BIP, as the same may be amended from time to
time.
1.57 "Territory" shall mean the Immunex Territory or the Wyeth Territory, as
applicable, and "Territories" shall mean both the Immunex Territory and
the Wyeth Territory, collectively.
1.58 "Third Party" shall mean any party other than Immunex, Wyeth, BIP, and
their respective Affiliates.
1.59 "Total BIOS Facility Capacity" shall mean the BIOS Capacity plus the
volume of Excluded Supply that can be produced in the biopharmaceutical
manufacturing facility to be built at the Wyeth BioPharma campus at Grange
Castle International Business Park, Clondalkin, Xxxxxx 00, Xxxxxxx.
1.60 "Type" shall mean Bulk Drug Substance produced by a specified
Manufacturing Process meeting a defined Specification approved by Immunex
and Wyeth pursuant to the provisions of the Quality Agreement.
1.61 "Work in Process" shall mean Bulk Drug Substance for which manufacturing
has commenced in a Calendar Year but which has not yet been released by
the end of such Calendar Year.
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1.62 "Wyeth Territory" shall mean all the countries in the world other than
those within the Immunex Territory.
Each of the following definitions are found in the body of this Agreement as
indicated:
Section
-------
"Additional Term" 14.1
"Adjusted Standard Product Price" 9.1(b)(iv)
"Base Allocation" 5.2(a)
"Clinical Development Requirements" 5.2(b)
"Cost of Goods" 2.2(d)
"Delivery Dates" 8.2
"Detailed Forecast Schedule" 8.2
"Firm Order" 8.2
"Five-Year Capacity Projection" 4.2(b)
"Five-Year Plan" 4.2(c)
"Five-Year Requirement Schedule" 4.2(a)
"Force Majeure Event" 16.1
"Greater Volume Party" 2.2(d)(i)
"Immunex License Agreements" 10.3
"Indemnitor" 13.3
"Indemnitee" 13.3
"Initial Term" 14.1
"JSC" 3.1
"Kg" 5.2(a)
"Liabilities" 13.1
"Lower Volume Party" 2.2(d)(i)
"Net Sales" 2.2(d)
"Product Development Steering Committee" 5.2(b)
"Product Gross Profits" 2.2(d)
"Production Plan" 4.2(c)(i)
"Publication" 15.4
"Reasonable Steps" 15.1
"RI Approval" 4.1
"Royalities" 2.2(d)
"Standard Product Price" 9.1(a)
"Sublicense Agreements" 10.3
"Supply Plan" 4.2(c)(ii)
"Technology Transfer and License Agreement" 7.3
"Term" 14.1
"Territory Shortage" 2.2(d)
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Article 2. Scope of Agreement; Subject Capacity
2.1 Scope of Agreement.
The purpose of the Collaboration is for the Parties to allocate and manage
in a collaborative manner the manufacture and supply of Product deriving
from the Subject Capacity.
2.2 Subject Capacity.
(a) Included Capacities. The Subject Capacity subject to the
Collaboration shall be composed of the following:
(i) the BIP Capacity;
(ii) the RI Capacity; and
(iii) the BIOS Capacity.
(b) Excluded Supply. Each Party shall be free to manufacture quantities
of Product in addition to those included in the Subject Capacity, or
to contract with a Third Party to manufacture at such Third Party's
facilities such additional Product, for use by such Party within its
Territory. All such additional quantities of Product Supply in
excess of those included in the Subject Capacity, whether
manufactured by or for a Party, shall be considered Excluded Supply
that is not included within the Subject Capacity and, except as
expressly set forth herein, shall not be subject to this Agreement.
Without limiting the generality of the foregoing, (i) Immunex may,
in its discretion, manufacture additional Product in the Phase B
Facility or elsewhere at the RI Site, which additional Product shall
be considered Excluded Supply, and (ii) Wyeth may, in its
discretion, manufacture additional Product at the BIOS Site in
excess of that included in the BIOS Capacity, which additional
Product shall be considered Excluded Supply.
(c) [*]
(d) Equivalency of Capacities. Until [*], all supply within the Subject
Capacity shall be allocated as set forth in this Agreement and
purchased by the Parties for the prices set forth in Article 9
(except as set forth in Section 2.2(c)), without regard for whether
the bioreactor working volume available from the RI Site is
equivalent to the bioreactor working volume available from the BIOS
Site. If, at any time after [*], the RI Site and the BIOS Site have
and continue to have substantially equivalent bioreactor working
volumes within the Subject Capacity, all supply within the Subject
Capacity shall be allocated as set forth in this Agreement and
purchased by the Parties for the prices set forth in Article 9
(except as set forth in Section 2.2(c)). Notwithstanding anything to
the contrary in this Agreement, if, at any time after [*], the RI
Site
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and the BIOS Site do not have and continue not to have substantially
equivalent bioreactor working volumes within the Subject Capacity,
all supply within the Subject Capacity shall be allocated as set
forth in this Agreement and purchased by the Parties at the
following prices:
(i) Supply from Equivalent Bioreactor Working Volumes. All supply
from an equivalent bioreactor working volume within the
Subject Capacity from the RI Site or the BIOS Site, as
applicable, shall be purchased by the Parties for the prices
set forth in Article 9 (except as set forth in Section
2.2(c)). If a Party (the "Lower Volume Party") has a lower
total bioreactor working volume in the Subject Capacity than
the total bioreactor working volume of the other Party (the
"Greater Volume Party") in the Subject Capacity with respect
to all or a portion of a particular Calendar Year after [*],
the supply from the Greater Volume Party to the Lower Volume
Party priced in accordance with Article 9 (except as set forth
in Section 2.2(c)) for such portion of such Calendar Year
shall equal [*].
(ii) Supply from Additional Bioreactor Working Volumes. Quantities
of Bulk Drug Substance allocated to the Lesser Volume Party in
the applicable Five-Year Plan in excess of the quantities
supplied to the Lower Volume Party from its own Site and the
BIP Site and quantities purchased pursuant to subsection (i)
above shall be purchased by the Lesser Volume Party from the
Greater Volume Party, and shall be priced as follows:
(A) Supply Shortage and Territory Shortage. If both a Supply
Shortage and a Territory Shortage are in effect with
respect to all or a portion of a particular Calendar
Year after [*], then such Bulk Drug Substance purchased
by the Lesser Volume Party shall be priced as follows
for that portion of such Calendar Year in which such
Supply Shortage and Territory Shortage are in effect:
(1) If Wyeth is the Lesser Volume Party, then Wyeth
shall pay Immunex for such Bulk Drug Substance the
sum of: (a) the Standard Product Price determined
as set forth in Section 9.1; and (b) the [*].
(2) If Immunex is the Lesser Volume Party, then
Immunex shall pay Wyeth for such Bulk Drug
Substance the sum of: (a) the Standard Product
Price determined as set forth in Section 9.1; and
(b) the [*].
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(B) Absence of Supply Shortage and/or Territory Shortage. If
either a Supply Shortage or a Territory Shortage is not
in effect, or if neither a Supply Shortage nor a
Territory Shortage is in effect, then such Bulk Drug
Substance purchased by the Lesser Volume Party shall be
priced as follows:
(1) the Fully Absorbed Manufacturing Cost allocated to
the manufacture of such Bulk Drug Substance; plus
(2) [*].
As used in this Section 2.2(d), "Territory Shortage" shall mean the
situation in which the [*]. As used in this Section 2.2(d), "Product
Gross Profits" shall mean Net Sales of Product Supply Units, less
the sum of Cost of Goods and Royalties. As used in this Section
2.2(d), "Cost of Goods" shall mean, with respect to Product Supply
Units, the total cost of finished goods, including, but not limited
to, the Bulk Drug Substance at the Standard Product Price, other
bulk materials, fill and finish, quality control, labeling,
packaging, and shipping to a Party or its agent, and storage. As
used in this Section 2.2(d), "Net Sales" shall mean the gross
invoice price of Product Supply Units sold in a Party's Territory by
a Party, its Affiliates, sublicensees, distributors, or other
designees to a Third Party after deducting, if not already deducted
in the amount invoiced or not otherwise accounted for in Cost of
Goods: (a) the standard inventory cost (actual acquisition cost) of
devices used for dispensing or administering such Product Supply
Units and that accompany such Product Supply Units as they are sold;
(b) then normal or customary trade, cash, and/or quantity discounts;
(c) returns, allowances, free goods, rebates, and chargebacks; (d)
retroactive price reductions applicable to sales of such Product
Supply Units; (e) fees paid to distributors, selling agents
(excluding any sales representatives of a Party or any of its
Affiliates), group purchasing organizations, or managed care
entities; (f) sales taxes, excise taxes, tariffs, and duties; and
(g) [*] of the amount invoiced to cover bad debt, freight, or other
transportation charges, insurance charges, additional special
packaging, and other governmental charges. As used in this Section
2.2(d), "Royalties" shall mean all running royalties paid to Third
Parties or to the other Party pursuant to Sublicense Agreements
under patent or technology licenses that are necessary or desirable
in order to manufacture, import, use, sell, or distribute Product,
provided that such royalties for purposes of the calculation of
Product Gross Profits shall be capped at [*] of Net Sales, and any
royalties above such amount shall be for the account of the Party
that sold such Product.
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Article 3. Governance
3.1 Joint Steering Committee.
The Parties hereby establish a Joint Steering Committee (the "JSC") to
manage the Collaboration. Each Party shall designate two (2) senior
executives to serve on the JSC on the basis of their expertise in
pharmaceutical manufacturing and supply management. The initial members of
the JSC are listed on Exhibit B attached hereto. A Party shall be free to
change either or both of its designated representatives upon reasonable
written notice to the other Party. The Parties shall be free to increase
the number of their respective representatives upon mutual agreement of
the Parties in writing. The JSC shall appoint a chairperson from among its
members, provided that the chairperson shall alternate between the Immunex
members and the Wyeth members on an annual basis.
3.2 Role of JSC.
The JSC shall be responsible for general management of the Collaboration.
Its responsibilities shall include, without limitation, the following:
(a) Reviewing and approving the Five-Year Requirement Schedules, as
further described in Section 4.2(a) below;
(b) Reviewing and approving the Five-Year Capacity Projections, as
further described in Section 4.2(b) below;
(c) Establishing, maintaining, and updating the Five-Year Plan, as
further described in Section 4.2(c) below;
(d) Overseeing the management of the Parties' joint relationship with
BIP, with other contractors performing services related to the
Product with regard to the Subject Capacity, and with suppliers of
raw materials and other supplies for the Product with regard to the
Subject Capacity;
(e) Serving as the initial forum for resolution of disputes between the
Parties related to matters within the scope of the Collaboration, as
set forth in Section 3.4 below;
(f) Establishing the quantities of safety inventories of Product to be
maintained by the Parties, except as set forth in Section 5.5 below;
(g) Establishing the operating guidelines pursuant to which the Parties
will allocate tasks to accomplish the effective functioning of the
Collaboration;
(h) Creating a quality review board and such other subcommittees as the
JSC deems necessary or appropriate for the effective functioning of
the Collaboration;
14
(i) Enforcing the responsibilities of and resolving disputes between the
finance representatives designated by the Parties as set forth in
Section 9.5(b);
(j) Making decisions regarding process improvements as set forth in
Section 7.4(a)(i); and
(k) Performing the other tasks specifically set forth herein, as well as
any other tasks that the JSC deems necessary or appropriate for the
effective functioning of the Collaboration.
Except as expressly set forth herein, or as determined by the JSC, the
Parties shall be bound by the decisions made by the JSC hereunder. Each
Party shall cause its members of the JSC to act in accordance with, and
perform the functions of the JSC required by, this Agreement.
3.3 Meetings.
The JSC shall meet as frequently as necessary to manage the Collaboration
effectively, but at least semi-annually. The Chairperson shall send
notices and agendas for all regular meetings to all JSC members. The
location of regularly scheduled meetings shall alternate between the
offices of the Parties. Meetings may be held telephonically, by video
conference, or by any other media agreed to by the JSC. Members of the JSC
shall have the right to participate in and vote at meetings by telephone
or proxy. Each Party shall have one (1) vote on all matters within the
jurisdiction of the JSC. The Party hosting any meeting shall appoint a
person to record the minutes of the meeting; such minutes shall be
circulated to the Parties promptly following the meeting for review,
comment, ratification, and distribution. Each Party shall bear its own
travel and related costs incurred in participation in the JSC. The JSC may
invite additional participants from relevant functions to attend JSC
meetings when appropriate for the issues being addressed at the meeting.
3.4 Dispute Resolution.
The JSC shall endeavor to reach a consensus on all matters within its
purview. In the event that the JSC cannot reach consensus on a matter, or
in the event that a disputed matter between the Parties is referred to the
JSC, the JSC shall strive to resolve such matter within a period of ten
(10) calendar days after the disputed matter is identified or referred to
the JSC in writing for resolution. If the JSC cannot reach a resolution
within the applicable time period (or earlier at the election of either
Party), the matter shall be referred to resolution in accordance with
Article 18 below.
Article 4. Allocation; Five-Year Plans
4.1 Short-Term Allocation.
Until either the FDA or EMEA has approved manufacture of Bulk Drug
Substance at the RI Site ("RI Approval"), the supply of Bulk Drug
Substance shall be allocated as follows:
15
(a) Product Manufactured at the BIP Site. Until RI Approval, Wyeth shall
have the right to receive such quantities of Bulk Drug Substance as
set forth in the Short-Term Allocation Agreement, pursuant to the
terms of the Short-Term Allocation Agreement, and any written
agreements involving both of the Parties relating to importation of
Product Supply Units from Immunex's customers into the Wyeth
Territory.
(b) Clinical Trial Material Manufactured at RI Site. In the event that
Bulk Drug Substance manufactured at the RI Site, prior to RI
Approval, is used in Product Supply for the Parties' clinical
trials, and such use permits additional Product manufactured at the
BIP Site to be allocated for use and used for the commercial market,
the amount of additional Product obtained for the commercial market
because of such substitution shall be [*]. The JSC shall determine
the amount of such Product, if any, subject to such allocation.
4.2 Five-Year Planning.
(a) Five-Year Requirement Schedules. On [*] each Party shall provide the
JSC with a written five-year requirement schedule (a "Five-Year
Requirement Schedule") for the period beginning [*] of its projected
requirements for Bulk Drug Substance from the Subject Capacity for
its Territory, net of Bulk Drug Substance reasonably expected to be
satisfied from Excluded Supply, according to Type, divided into
monthly increments for the first Calendar Year and divided into
yearly increments for the remaining four (4) Calendar Years. By each
[*] thereafter, each Party shall submit to the JSC an updated
Five-Year Requirement Schedule for the period beginning [*] of the
following Calendar Year. Within thirty (30) days after each such
submission, the JSC shall review the Five-Year Requirement
Schedules, and either, at its discretion, approve the Five-Year
Requirement Schedules, or request additional information from the
Parties as needed to use the Five-Year Requirement Schedules to
establish the Five-Year Plan. At the JSC's discretion and request,
the Parties shall update their Five-Year Requirement Schedules by
each [*] thereafter. Each Five-Year Requirement Schedule provided
hereunder shall include, for each Calendar Year included therein:
(i) total Bulk Drug Substance requirements from the Subject
Capacity, separated according to Type, on a region-by-region
basis;
(ii) Bulk Drug Substance requirements by indication on a
Territory-wide basis, separated according to Type;
(iii) a schedule of expected dates of submission and approval by
Regulatory Authorities, on a country-by-country basis within
such Party's Territory, of initial marketing applications for
the Product, and
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supplemental submissions for additional indications to be
added to the Product labeling;
(iv) information concerning sales of Product during the preceding
six (6) months on a Territory-wide basis; and
(v) any other information reasonably requested by the JSC.
(b) Five-Year Capacity Projections. On [*], each Party shall provide the
JSC with a written five-year capacity projection (a "Five-Year
Capacity Projection") beginning [*] for the Subject Capacity from
each of its Sites according to Type, divided into monthly increments
for the first Calendar Year of a Capacity Projection and divided
into yearly increments for the remaining four Calendar Years of a
Capacity Projection. Immunex shall submit the Five-Year Capacity
Projection for the BIP Site and the RI Site, and Wyeth shall submit
the Five-Year Capacity Projection for the BIOS Site. By each [*]
thereafter, each Party shall submit to the JSC an updated Five-Year
Capacity Projection for the period beginning [*] of the following
Calendar Year. Within thirty (30) days after each such submission,
the JSC shall review the Five-Year Capacity Projections, and either,
at its discretion, approve the Five-Year Capacity Projections, or
request additional information from the Parties as needed to use the
Five-Year Capacity Projections to establish the Five-Year Plan. At
the JSC's discretion and request, the Parties shall update their
Five-Year Capacity Projections by each [*] thereafter. Each
Five-Year Capacity Projection provided hereunder shall include, for
each year included therein:
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(i) the total quantity of Bulk Drug Substance that can reasonably
be expected to be produced and released at the Site within
bioreactors included in the Subject Capacity, separated
according to Type;
(ii) the projected Standard Product Price for Released Bulk Drug
Substance at the Site within bioreactors included in the
Subject Capacity, according to Type, which price shall be
non-binding on the Parties;
(iii) a schedule of expected dates of submissions to and approval by
Regulatory Authorities, of Regulatory Filings regarding
additional Sites to manufacture the Product and process and
other changes, on a regional or country-by-country basis;
(iv) inventory of Product on hand from the Subject Capacity,
separated according to Type, on a region-by-region basis, as
of one month before the date of submission of the such
Five-Year Capacity Projection; and
(v) any other information reasonably requested by the JSC.
(c) Five-Year Plan. By [*], and by each [*] thereafter during the Term,
the JSC shall establish the "Five-Year Plan" for the upcoming five
(5) Calendar Years. The JSC shall determine, in its discretion,
whether it is necessary to adjust each such Five-Year Plan after
receiving submissions from the Parties by each [*] and, shall make
any such necessary adjustments. The Five-Year Plan shall include,
for each Calendar Year included therein, a Production Plan and a
Supply Plan, as further described below.
(i) Production Plan. Each Five-Year Plan shall indicate the
quantity of Bulk Drug Substance separated according to Type
reasonably expected to be manufactured and released at each
specific Site within the Subject Capacity (the "Production
Plan"). The Production Plan shall be established on a Calendar
Year basis within the applicable Five-Year Plan.
(ii) Supply Plan. Each Five-Year Plan shall indicate: (A) the
quantity of Bulk Drug Substance reasonably expected to be
supplied to each of the Territories separated according to
Type; and (B) the quantity of Bulk Drug Substance reasonably
expected to be manufactured at each specific Site separated
according to Type to be supplied to each of the Parties for
their respective Territories (the "Supply Plan"). The Supply
Plan shall be established on a monthly basis for the first
Calendar Year included in the Five-Year Plan, and on a
Calendar Year basis for the remaining four (4) Calendar Years
within the Five-Year Plan, on a Territory-wide basis.
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(iii) Reconciliation. In establishing a Five-Year Plan, the JSC
shall review the Bulk Drug Substance that was actually
distributed to the Parties from the Subject Capacity during
the preceding Calendar Year to determine whether the capacity
actually received by each Party during the preceding Calendar
Year equaled the capacity to which each Party was entitled
pursuant to this Agreement. If one Party did not receive the
capacity from the Subject Capacity to which such Party was
entitled under the Five-Year Plan for such preceding Calendar
Year, the JSC shall make any appropriate adjustments to the
Five-Year Plan that it is establishing to account for such
discrepancy.
4.3 General Principles of Allocation.
In the absence of a Supply Shortage or a Production Surplus, the JSC shall
be guided by the following principles in establishing the Five-Year Plans.
(a) The JSC shall use its best efforts to prevent any out-of-stock
situation in any Major Market, including but not limited to
resolving any short supply issues for each Type. The JSC shall use
its commercially reasonable efforts to prevent any out-of-stock
situation in any non-Major Market, including but not limited to
resolving any short supply issues for each Type.
(b) [*]
(c) The JSC shall use its best efforts to prevent out-dating of Bulk
Drug Substance.
(d) The JSC shall use its best efforts to minimize costs to the extent
they impact the Blended Price.
(e) The JSC shall use its best efforts to allocate supply such that each
Party receives the Type of Bulk Drug Substance that such Party
requires.
4.4 Binding Portion of Five-Year Plan.
The [*] of each Five-Year Plan shall be binding on the Parties.
Notwithstanding anything herein to the contrary, the initial Five-Year
Plan shall not become effective nor bind the Parties until RI Approval,
and prior to that time, the supply of Bulk Drug Substance shall be
allocated according to Section 4.1 above. The JSC shall not change a
binding portion of a Five-Year Plan. The Parties shall be obligated to
utilize the capacity and to purchase the quantities of Bulk Drug Substance
set forth in the binding portion of the Five-Year Plan. The remaining
portions of a Five-Year Plan shall not be binding on the Parties, but the
Parties shall use such Five-Year Plan for joint planning purposes.
4.5 Specific Product Purchases.
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The Parties shall purchase Product from each other in the quantities
specified in the Five-Year Plan, according to the terms set forth in this
Agreement.
(a) BIP Site. Under the Enbrel Supply Agreement, the Parties have the
option to receive Bulk Drug Substance Lots manufactured by BIP; the
remainder of the Bulk Drug Substance manufactured by BIP is
converted by BIP to Drug Product and/or Finished Product that is
sold to the Parties thereunder.
(i) In the event that a Party desires to receive Bulk Drug
Substance from BIP, such Party shall so specify in its
Five-Year Requirement Schedule submitted to the JSC. The JSC
shall approve any such request that complies with the Enbrel
Supply Agreement or, if necessary, shall limit the quantities
of Bulk Drug Substance requested by one or both Parties to
ensure such compliance. Any Party who requests Bulk Drug
Substance from BIP shall pay BIP the cost therefor under the
Enbrel Supply Agreement and shall bear the cost of and the
risk of loss during the fill-finish, labeling, packaging, and
other services necessary to convert such Bulk Drug Substance
to Product Supply.
(ii) In the event that a Party requests Drug Product or Finished
Product from BIP, such Party shall pay BIP the cost therefor
under the Enbrel Supply Agreement and shall bear the cost of
the labeling, packaging, and other services necessary to
convert such Product to Product Supply.
(b) RI Site.
(i) For the quantities of Bulk Drug Substance that Wyeth receives
from the RI Site, Wyeth shall purchase the Bulk Drug Substance
form of the Product and shall pay Immunex therefor in
accordance with Article 9 below. Wyeth may enter into an
agreement with Immunex or a Third Party pursuant to which
Immunex or a Third Party would perform certain fill-finishing,
labeling, packaging, and other services necessary to convert
such Bulk Drug Substance to Product Supply on terms and
conditions mutually agreed upon in writing by Wyeth and
Immunex, or a Third Party, as applicable.
(ii) When (A) more than [*] liter nominal volume bioreactors are
used to produce Bulk Drug Substance in the Phase B Facility in
a given Calendar Year, or, (B) if the Phase A Capacity is
moved to the Phase B Facility, more than [*] liter nominal
volume bioreactors are used to produce Bulk Drug Substance in
the Phase B Facility in a given Calendar Year, the quantity of
Bulk Drug Substance subject to allocation and purchase in
accordance with the applicable Five-Year Plan shall equal the
[*].
(c) BIOS Site.
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(i) For the quantities of Bulk Drug Substance that Immunex
receives from the BIOS Site, Immunex shall purchase the Bulk
Drug Substance form of the Product and shall pay Wyeth
therefor in accordance with Article 9 below. Immunex may enter
into an agreement with Wyeth or a Third Party pursuant to
which Wyeth or a Third Party would perform certain
fill-finishing, labeling, packaging, and other services
necessary to convert such Bulk Drug Substance to Product
Supply on terms and conditions mutually agreed upon in writing
by Immunex and Wyeth, or a Third Party, as applicable.
(ii) If a greater number of bioreactors than those included in the
BIOS Capacity are used to produce Bulk Drug Substance in the
Total BIOS Facility Capacity in a given Calendar Year, the
quantity of Bulk Drug Substance subject to allocation and
purchase in accordance with the applicable Five-Year Plan
shall equal the [*].
Article 5. Product Allocation During Supply Shortage
5.1 Scope.
Except as set forth in Section 5.6 below, in the event that there is a
Supply Shortage, the JSC shall allocate the total quantity of Bulk Drug
Substance manufactured in the Subject Capacity as set forth in this
Article 5, for each of the Calendar Years for which the Supply Shortage is
in effect pursuant to Section 1.54 above.
5.2 Allocation of Combined BIP Capacity and Phase A Capacity.
The total volume of Bulk Drug Substance available from the combined BIP
Capacity and Phase A Capacity shall be allocated as follows, in the
following priority:
(a) Base Allocation. The first [*] Kilograms ("Kg ") of Bulk Drug
Substance available from the combined BIP Capacity and Phase A
Capacity (the "Base Allocation") shall be allocated as follows:
(i) Immunex shall receive [*] Kg; and
(ii) Wyeth shall receive [*] Kg.
In the event that fewer than [*] Kg of Bulk Drug Substance are
available from the combined BIP Capacity and Phase A Capacity, then
Immunex shall receive [*] and Wyeth shall receive [*] of the
available quantities.
(b) Clinical Development Requirements. Additional volumes of Bulk Drug
Substance above the Base Allocation that are available from the
combined
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BIP Capacity and Phase A Capacity, if any, shall be used to satisfy
any ongoing clinical trials being conducted by the Parties, as well
as any new clinical trials agreed upon by the "Product Development
Steering Committee" under the TNFR Agreement (as that term is
defined therein) (collectively, the "Clinical Development
Requirements"). [*] To the extent that the Parties agree that excess
quantities of Bulk Drug Substance from the quantities allocated to
the Clinical Development Requirements are available from time to
time, such quantities shall be allocated as follows:
(i) If the Base Allocation has not been satisfied as set forth in
Section 5.2(a) in the Calendar Years in which the Parties
agree that excess quantities are available, the excess
quantities shall be allocated as set forth in Section 5.2(a).
(ii) If the Base Allocation has already been satisfied as set forth
in Section 5.2(a) in the Calendar Years in which the Parties
agree that excess quantities are available, the excess
quantities shall be allocated as set forth in Section 5.2(c).
(c) Additional Quantities. Additional quantities of Bulk Drug Substance
that are available from the combined BIP Capacity and Phase A
Capacity, if any, above that necessary to satisfy the Base
Allocation and the Clinical Development Requirements, shall be
allocated as follows:
Immunex Wyeth
--------------------------------------------------------------------
First [*] Kg or portion thereof [*] [*]
--------------------------------------------------------------------
Next [*] Kg or portion thereof [*] [*]
--------------------------------------------------------------------
Next [*] Kg or portion thereof [*] [*]
--------------------------------------------------------------------
Next [*] Kg or portion thereof [*] [*]
--------------------------------------------------------------------
All additional supplies from the combined
BIP Capacity and Phase A Capacity [*] [*]
--------------------------------------------------------------------
(d) Example. By way of example only, the following table demonstrates
how the quantities of total Bulk Drug Substance available from the
BIP and Phase A Capacity, as shown below, would be allocated during
a Supply Shortage. (The numbers shown below have been rounded to the
nearest 0.5 Kg.)
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----------------------------------------------------------------------
Clinical
Total Supply from BIP Development
Capacity and from Phase A Immunex Wyeth Requirements
Capacity Kg Kg Kg
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------
5.3 Allocation of Phase B Additional Capacity.
In the event of a Supply Shortage, the volume of Bulk Drug Substance
available from the Phase B Additional Capacity shall be allocated [*] to
Immunex and [*] to Wyeth.
5.4 Allocation of BIOS Capacity.
In the event of a Supply Shortage, the volume of Bulk Drug Substance
available from the BIOS Capacity shall be allocated [*] to Wyeth and [*]
to Immunex.
5.5 Safety Stock.
During any period of Supply Shortage, each Party shall be responsible for
maintaining its own inventory of safety stock from among the quantities it
is allocated pursuant to this Article 5.
5.6 Sale of Product between Parties.
If there is a Supply Shortage and the allocation of Bulk Drug Substance
according to this Article 5 provides a Party with excess supply above that
required to meet such Party's supply needs, as determined in such Party's
sole discretion, such Party shall have the right, but not the obligation,
to sell additional Bulk Drug Substance to the other Party beyond that
allocated to such other Party according to this Article 5; provided,
however, that any such quantities of Bulk Drug Substance that derive from
the Subject Capacity and are sold by one Party to the other Party shall be
sold at a price that does not exceed the applicable Blended Price
established for such Bulk Drug Substance during the Calendar Year in which
the sale occurs.
5.7 Allocation According to Type.
In establishing a Five-Year Plan, the JSC shall use its best efforts to
allocate to a Party the Type of Bulk Drug Substance required by such
Party. If the JSC is bound, according to this Article 5, to allocate a
certain percentage of Bulk Drug Substance from one Site or a portion
thereof to a Party, and such Site manufactures a particular Type of Bulk
Drug Substance that is not required by such Party, the JSC shall
substitute an equivalent quantity of Bulk Drug Substance from a different
Site that produces a Type required by such Party, and shall make any
necessary corresponding adjustments to maintain compliance with Article 5.
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Article 6. Product Allocation During Production Surplus
6.1 Allocation.
In the event that there is a Production Surplus, the total quantity of
Bulk Drug Substance that can be manufactured in the Subject Capacity shall
be allocated as set forth below.
(a) BIP Obligations. [*].
(b) Additional Supply Needs. If there is additional demand for Product
Supply beyond the quantities produced as a result of the allocation
to the BIP Capacity under Section 6.1(a) above, then production
shall be allocated among the RI Capacity and the BIOS Capacity
according to the following formula.
[*]
(c) Example. By way of example only, assume that the respective
capacities of the Subject Capacities as follows:
BIP Capacity: [*]
RI Capacity: [*]
BIOS Capacity: [*]
Total: [*]
Assume further that (i) the worldwide demand for Product Supply is
[*] per year, and (ii) the Parties must purchase [*] from BIP to
meet their minimum contractual obligation under the Enbrel Supply
Agreement. Production shall be allocated as follows:
BIP Capacity: [*]
RI Capacity: [*]
BIOS Capacity: [*]
Article 7. Manufacturing Strategy
7.1 Regulatory Approvals.
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The Parties shall cooperate in good faith and use all commercially
reasonable efforts to obtain approval from the applicable Regulatory
Authorities for each Site to manufacture Bulk Drug Substance for each of
the Major Markets. Immunex shall be responsible for all Regulatory Filings
for each Site to enable each Site to manufacture Bulk Drug Substance for
countries within the Immunex Territory as deemed necessary by Immunex, and
Wyeth shall be responsible for all Regulatory Filings for each Site to
enable each Site to manufacture Bulk Drug Substance for countries within
the Wyeth Territory as deemed necessary by Wyeth. Each Party shall offer
its reasonable assistance to the other Party in preparing any such
Regulatory Filings. Each Party shall reimburse the other for [*] incurred
by such other Party in connection with the performance of such other
Party's obligations under the preceding sentence. The Parties shall
attempt to obtain such approvals as quickly as practicable. The Parties
shall attempt to qualify the Subject Capacity in those Major Markets where
the qualification is reasonably likely to be obtained the earliest, as
agreed upon by Immunex and Wyeth; provided, however, that the Parties
shall simultaneously use all commercially reasonable efforts to qualify
the Subject Capacity for manufacturing Bulk Drug Substance for use in the
United States, the European Union, and Japan.
7.2 Raw Materials and Supplies.
(a) General. Each Site shall be responsible for purchasing the raw
materials and other supplies necessary to manufacture Bulk Drug
Substance, Drug Product, and/or Finished Product, as applicable, at
its location. The Parties shall, however, cooperate with regard to
purchasing from specific suppliers, particularly sole source
suppliers, and shall, when reasonably practicable, enter into joint
contracts or other purchasing arrangements with suppliers, with the
objective of obtaining more favorable pricing and other terms than
if such Party was purchasing alone. In addition, the Parties shall
cooperate in working with BIP in purchasing from such suppliers. The
JSC shall direct the Parties' management of the relationship with
common suppliers, and in the event that entering into a joint
purchasing arrangement with a sole source supplier is not reasonably
practicable, then the JSC shall oversee and direct each Party's
individual contractual relationship with such supplier. Section 5.3
of the Quality Agreement addresses quality issues related to raw
materials.
(b) Shortage. [*]
7.3 Technology Transfer and License.
Immunex and Wyeth shall enter into a technology transfer and license
agreement simultaneously herewith setting forth the terms and conditions
simultaneously herewith pursuant to which transfer of the technology for
the Manufacturing Process to Wyeth will occur (the "Technology Transfer
and License Agreement").
7.4 Changes to the Product.
(a) Process Changes.
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(i) The Parties shall collaborate with regard to any process
improvement efforts for the Manufacturing Process. The JSC
shall make all decisions regarding joint investments for
development work for process improvements, allocating costs of
such development work if such costs are to be allocated other
than as set forth in Section 3.05 of the TNFR Agreement,
whether to implement any such jointly funded process
improvements into the Manufacturing Process, the timing of
such implementation at the various Sites, [*]. The JSC shall
consider the requirements of all countries within the
Territories in determining whether to jointly fund development
work for process improvements.
(ii) The Parties, through the JSC, shall cooperate in good faith to
help ensure that, as improvements to the Manufacturing Process
are implemented, [*].
(iii) Implementation of process changes is also addressed in Article
10 of the Quality Agreement.
(b) Other Changes. The Parties' technical, production scheduling,
regulatory and other appropriate personnel shall work together to
coordinate other changes to the Product, including but not limited
to formulation changes, presentation changes [*], and assay changes.
The JSC shall provide general direction to the Parties with respect
to the implementation and timing of such changes, with the objective
of ensuring that (i) Product incorporating a particular change is
available from one or more of the Sites to support the Major Markets
where such change is approved, (ii) to the extent commercially
practicable, Product not incorporating a particular change is
available from one or more of the Sites to support the Major Markets
where such change is not approved, and (iii) Product inventory is
managed appropriately to accomplish (i) and (ii) above and to
implement changes as efficiently as possible. Implementation of such
changes is also addressed in Article 10 of the Quality Agreement.
7.5 Manufacturing Strategy.
The Parties shall use commercially reasonable efforts to manufacture Bulk
Drug Substance to meet [*] Regulatory Requirements in the Major Markets.
[*] Any disputes regarding the foregoing shall be resolved as set forth in
the Quality Agreement.
7.6 Quality Agreement.
Immunex and Wyeth shall comply with the provisions of the Quality
Agreement. To the extent possible, the provisions of the Quality Agreement
shall be interpreted consistently with the provisions of this Agreement.
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Article 8. Supply of Bulk Drug Substance Between Immunex and Wyeth
8.1 Supply of Bulk Drug Substance.
Immunex shall supply Bulk Drug Substance to Wyeth from the RI Site, and
Wyeth shall supply Bulk Drug Substance to Immunex from the BIOS Site,
subject to the terms and conditions of this Agreement and the Quality
Agreement. All Bulk Drug Substance supplied by Immunex or Wyeth hereunder
shall conform to the provisions of the Quality Agreement, including,
without limitation, the Specifications for such Bulk Drug Substance set
forth in the Quality Agreement.
8.2 Forecasts.
On the [*] after each Five-Year Plan is established pursuant to Section
4.2(c), each of Immunex and Wyeth shall provide to the other a One Year
"Detailed Forecast Schedule" for the amount of [*] of Bulk Drug Substance,
separated according to Type, to be delivered on delivery dates (the
"Delivery Dates"), by [*], for the following Calendar Year. The Detailed
Forecast Schedule shall be considered a "Firm Order" in accordance with
the binding portion of the Five Year Plan.
8.3 Delivery.
(a) Delivery Terms. Wyeth and Immunex shall each arrange for shipment of
the Bulk Drug Substance to the other Party and/or its respective
designee at the purchasing Party's expense, F.O.B. the purchasing
Party's designated carrier, and in accordance with the purchasing
Party's instructions, including instructions as to designated
carrier(s) to utilize. Title to, and risk of loss of, the Bulk Drug
Substance shall remain with the supplying Party until delivery to
the designated carrier specified by the purchasing Party, at which
time the purchasing Party shall assume risk of loss of the Bulk Drug
Substance.
(b) Filling Firm Orders. The supplying Party shall fulfill each Firm
Order submitted pursuant to Section 8.2 above, for such quantities
of Bulk Drug Substance specified in such Firm Order for each
purchasing Party, on or before the specified Delivery Date
applicable thereto and in accordance with any instructions of the
purchasing Party; provided, however, that the Parties shall deliver
Bulk Drug Substance in whole Bulk Drug Substance Lots.
Notwithstanding anything herein to the contrary, if supply from a
Bulk Drug Substance Lot is lower than expected, the deficiency shall
not constitute a breach of an obligation to fulfill a Firm Order. If
a Supply Shortage is in effect when such deficiency occurs, Immunex
and Wyeth shall receive a reduced quantity of Bulk Drug Substance to
accommodate such deficiency proportionately based on the allocation
set forth in the applicable Five-Year Plan on a monthly basis. If a
Supply Shortage is not in effect when such deficiency occurs, the
deficient quantity shall be placed on backorder.
(c) Delivery Schedule. The Parties will cooperate to maintain a
non-binding rolling [*] delivery schedule. Such schedule shall be
updated at least monthly
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and will specify the quantity of and delivery dates for Bulk Drug
Substance to be delivered in the next [*].
(d) Compliance. Each Party shall comply with all applicable laws and
regulations regarding the transportation and shipment of the Bulk
Drug Substance for all deliveries made by such Party pursuant to
this Agreement.
8.4 Division of Orders for and Delivery of Allocated Supply.
The Parties will use commercially reasonable efforts to deliver Product in
accordance with the binding forecast (as described in Section 4.4) in each
month of the Detailed Forecast Schedule, unless otherwise agreed by the
Parties in writing.
8.5 Product Warranties.
(a) Warranties by Wyeth. Wyeth hereby warrants to Immunex that the Bulk
Drug Substance that Immunex purchases from Wyeth under this
Agreement, at the time of sale and shipment by Wyeth: (i) shall
conform to the provisions of the Quality Agreement, including,
without limitation, the applicable Specifications for such Bulk Drug
Substance; (ii) shall have been manufactured in compliance with all
Regulatory Requirements in the United States; and (iii) shall be
transferred free and clear of any liens or encumbrances of any kind
related to Wyeth's activities hereunder.
(b) Warranties by Immunex. Immunex hereby warrants to Wyeth that the
Bulk Drug Substance that Wyeth purchases from Immunex under this
Agreement, at the time of sale and shipment by Immunex: (i) shall
conform to the provisions of the Quality Agreement, including,
without limitation, the applicable Specifications for such Bulk Drug
Substance; (ii) shall have been manufactured in compliance with all
Regulatory Requirements in the Major Markets; and (iii) shall be
transferred free and clear of any liens or encumbrances of any kind
related to Immunex's activities hereunder.
(c) Continuing Warranties. The warranties set forth in this Section
8.5(a) and (b) shall be continuing warranties and shall be
applicable to all of the Bulk Drug Substance delivered by Wyeth or
Immunex to the other Party pursuant to this Agreement.
(d) Disclaimer. THE WARRANTIES SET FORTH IN SECTIONS 8.5(a) AND 8.5(b)
ABOVE ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTIES
EXPRESSED IN SECTIONS 8.5(a) AND 8.5(b) ABOVE, NEITHER PARTY MAKES
ANY OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE
PRODUCT.
8.6 Validation.
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Product and process validation shall be governed by Article 11 of the
Quality Agreement.
8.7 Claims.
(a) Notice of Claims. In the event that any of the Bulk Drug Substance
supplied hereunder shall fail to conform with any warranty set forth
in Section 8.5(a) or Section 8.5(b) hereof, the purchasing Party may
reject the same by giving written notice thereof to the supplying
Party within [*] days after shipment (or in the case of a latent
defect, within [*] days after discovery of such latent defect, but
in no case later than [*] after delivery to the designated carrier
specified by the purchasing Party), which notice shall specify the
manner in which such Bulk Drug Substance fails to conform to any
warranty. In the alternative, rather than initially issuing a notice
of rejection, the purchasing Party may give written notice to the
supplying Party within the time period specified in this Section
8.7(a) of a decision by the purchasing Party to investigate whether
a potentially nonconforming shipment should be rejected, which
investigation shall, unless otherwise agreed upon by the Parties, be
completed within the time period set forth in this Section 8.7(a).
(b) No Supplier Liability. If it is determined by agreement of Immunex
and Wyeth (or in the absence of such agreement, by a mutually
acceptable qualified Third Party whose determination shall be
binding on Immunex and Wyeth and whose fees shall be paid by the
non-prevailing Party) that the nonconformity is due to damage to the
Bulk Drug Substance caused by the purchasing Party or its agents
subsequent to delivery of such Bulk Drug Substance by the supplying
Party, the supplying Party shall have no liability to Purchaser with
respect thereto.
(c) Supplier Liability; Replacement Product. If it is determined by
agreement of Immunex and Wyeth (or in the absence of such agreement,
by a mutually acceptable qualified Third Party whose determination
shall be binding on Immunex and Wyeth and whose fees shall be paid
by the non-prevailing Party) that the nonconformity is caused by the
supplying Party, the supplying Party shall as soon as reasonably
possible replace such nonconforming Bulk Drug Substance with
conforming Bulk Drug Substance, at no additional cost to the
purchasing Party, and the supplying Party shall pay the full cost of
disposal or return of such Bulk Drug Substance to the supplying
Party.
(d) Disposition of Nonconforming Product. In any case where a purchasing
Party expects to make a claim against a supplying Party with respect
to damaged or otherwise nonconforming Bulk Drug Substance, the
purchasing Party shall not dispose of or allow to be disposed such
Product without written authorization and instructions of the
supplying Party either to dispose of or return to the supplying
Party such Bulk Drug Substance. Upon written request by the
purchasing Party, the supplying Party agrees promptly to give the
purchasing Party such authorization and instructions within a
reasonable period of time.
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8.8 Manufacturing Audits, Regulatory Matters.
(a) Manufacturing Audits. The Parties shall have the right to perform
manufacturing audits as set forth in Sections 8.4 and 8.5 of the
Quality Agreement.
(b) Records. Each Party shall maintain records relating to the
production of the Product hereunder in accordance with Section 7.6
of the Quality Agreement. Each Party agrees that, in response to any
complaint or in the defense by the other Party of any litigation,
hearing, regulatory proceeding or investigation relating to the
Product, it shall use reasonable efforts to make available to the
other Party during normal business hours and upon reasonable prior
written notice, such Party's employees and records reasonably
necessary to permit the effective response to, defense of, or
investigation of such matters, subject to appropriate
confidentiality protections. Each Party shall reimburse the other
for [*] by such other Party in connection with the performance of
such other Party's obligations under the preceding sentence.
(c) Notification to Other Party of Regulatory Correspondence. Within [*]
business days after receiving or finalizing such document, each of
Immunex and Wyeth shall promptly notify the other Party in writing
of, and shall provide each other with copies of, any correspondence
and other documentation received or prepared by such Party in
connection with receipt of a regulatory letter, warning, or similar
item, from any Regulatory Authority related to an inspection of the
RI Site or the BIOS Site, as applicable, that could affect
production of the Product; (ii) any recall, market withdrawal or
correction of any lot of any Product provided by such Party to the
other Party hereunder; and (iii) any comments by a Regulatory
Authority concerning the Product requiring a response or action by
Immunex or Wyeth.
8.9 Recalls.
(a) Immunex Territory. Each Party shall notify the other Party promptly
(and, in any event, within [*] business days of receipt of written
notice) if any Bulk Drug Substance, Finished Product, Drug Product,
or Product Supply is alleged or proven to be the subject of a
recall, market withdrawal or correction in any country in the
Immunex Territory. Immunex and Wyeth shall cooperate in the handling
and disposition of such recall, market withdrawal or correction in
the Immunex Territory; provided, however, that in the event of
disagreement as to any matters related to such recall, market
withdrawal or correction, other than the determination of who shall
bear the costs as set forth in the immediately following sentence,
Immunex, after consultation with Wyeth, shall have final authority
with respect to such matters in the Immunex Territory, which
authority shall be exercised reasonably in and in good faith.
Immunex shall bear the cost of all recalls, market withdrawals, or
corrections of Bulk Drug Substance, Finished Product, Drug Product,
or Product Supply in the Immunex Territory unless such recall,
market withdrawal or correction shall have
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been the result of any breach of Wyeth's covenants, representations,
or warranties set forth in this Agreement or shall have been the
result of Wyeth's grossly negligent breach of any of its obligations
hereunder, in which case Wyeth shall, upon substantiation, bear the
cost of such recall, market withdrawal, or correction. Immunex or
its agent shall in all events be responsible for conducting any
recalls, market withdrawals or corrections with respect to Bulk
Substance, Finished Product, Drug Product, or Product Supply in the
Immunex Territory.
(b) Wyeth Territory. Each Party shall notify the other Party promptly
(and, in any event, within [*] business days of receipt of written
notice) if any Bulk Drug Substance, Finished Product, Drug Product,
or Product Supply is alleged or proven to be the subject of a
recall, market withdrawal or correction in any country in the Wyeth
Territory. Immunex and Wyeth shall cooperate in the handling and
disposition of such recall, market withdrawal or correction in the
Wyeth Territory; provided, however, that in the event of
disagreement as to any matters related to such recall, market
withdrawal or correction, other than the determination of who shall
bear the costs as set forth in the immediately following sentence,
Wyeth, after consultation with Immunex, shall have final authority
with respect to such matters in the Wyeth Territory, which authority
shall be exercised reasonably in and in good faith. Wyeth shall bear
the cost of all recalls, market withdrawals, or corrections of Bulk
Drug Substance, Finished Product, Drug Product, or Product Supply in
the Wyeth Territory unless such recall, market withdrawal or
correction shall have been the result of any breach of Immunex's
covenants, representations, or warranties set forth in this
Agreement or shall have been the result of Immunex's grossly
negligent breach of any of its obligations hereunder, in which case
Immunex shall, upon substantiation, bear the cost of such recall,
market withdrawal, or correction. Wyeth or its agent shall in all
events be responsible for conducting any recalls, market withdrawals
or corrections with respect to Bulk Substance, Finished Product,
Drug Product, or Product Supply in the Wyeth Territory.
8.10 Safety Agreement.
Immunex and Wyeth shall comply with the provisions of the Safety
Agreement. To the extent possible, the provisions of the Safety Agreement
shall be interpreted consistently with the provisions of this Agreement.
In the event of a conflict between the provisions of the Safety Agreement
and the provisions of this Agreement, the provisions of this Agreement
shall control.
Article 9. Pricing of Product Between the Parties
9.1 Standard Product Prices.
(a) Calculation. For each Calendar Year (or portion thereof remaining in
the Term) for which a Five-Year Plan is in effect, a "Standard
Product Price" for
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Bulk Drug Substance manufactured at each of the Sites will be
established, [*], as further described below. A separate Standard
Product Price shall be calculated for Bulk Drug Substance
manufactured using [*], Bulk Substance manufactured using the T1
Process, and Bulk Drug Substance manufactured using the T2 Process,
if each such Manufacturing Process is being used at one or more
Sites, and all references to calculation or adjustment of the
Standard Product Price shall include all such Standard Product
Prices, if applicable.
(i) RI Site and BIOS Site. For the RI Site and the BIOS Site, the
Standard Product Price shall be calculated, for a particular
Calendar Year, by [*]
In such calculation, the Fully Absorbed Manufacturing Cost
shall first be allocated between all Released Bulk Drug
Substance for which the release is completed during such
Calendar Year and Bulk Drug Substance that is Work In Process
at the end of such Calendar Year. The Fully Absorbed
Manufacturing Cost for all Released Bulk Drug Substance for
which the release is completed during such Calendar Year shall
be included, and the Fully Absorbed Manufacturing Cost for
Bulk Drug Substance that is Work In Process at the end of such
Calendar Year shall be carried over and used in calculating
the Standard Product Price in the Calendar Year that such Bulk
Drug Substance is released. The Standard Product Price for the
RI Site and the BIOS Site shall not include any Excluded
Supply, unless the Excluded Supply is manufactured in the same
manufacturing facility at the Site as the Subject Capacity, in
which case Excluded Supply shall be included in both
subsections (A) and (B) of the calculation above.
(ii) BIP Site. For Product manufactured at the BIP Site, the
Standard Product Price for Bulk Drug Substance will be
calculated, for a particular Calendar Year, by [*]
The Standard Product Price shall be calculated for Bulk Drug
Substance to be purchased by the Parties, whether purchased in
the form of Bulk Drug Substance itself or as incorporated into
Drug Product or Finished Product. If incorporated into Drug
Product or Finished Product, the Standard Product Price will
be calculated based on the portion of the price attributable
to Bulk Drug Substance.
(b) Schedule for Establishing Standard Product Prices.
(i) BIP Site. Within [*] after the Effective Date, and thereafter
on or before [*] of each Calendar Year, the Parties shall
submit to each other in writing the total quantity of Product
that each plans to purchase from BIP during the following
Calendar Year in accordance with the binding Supply Allocation
for such Calendar Year in the Five-Year Plan, along
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with the cost of the Bulk Drug Substance used in such Product
in U.S. dollars. The Parties shall cooperate in good faith in
using such information to determine the Standard Product Price
for Bulk Drug Substance for the BIP Site.
(ii) RI and BIOS Sites. Immunex shall be responsible for
establishing the Standard Product Price for the RI Site. Wyeth
shall be responsible for establishing the Standard Product
Price for the BIOS Site. Within [*] after the Effective Date,
and thereafter on or before [*] of each Calendar Year, each
Party shall submit to the other in writing (A) the Standard
Product Price for the following Calendar Year for the Site(s)
for which it bears responsibility according to the previous
sentence, and (B) its planned purchases from the Site owned by
the other Party (pursuant to the applicable Five-Year Plan
issued by the JSC) during the following Calendar Year, and (c)
the quantity of Bulk Drug Substance deriving from the Subject
Capacity at its own Site that such Party plans to manufacture
for its own use.
(iii) Finalizing Standard Product Prices and Projected Blended
Price. Within thirty (30) days after receiving the initial
submissions pursuant to Section 9.1(b)(i) and (ii) above, and
thereafter by no later than [*] of each subsequent Calendar
Year, the Parties shall agree upon in writing (A) the Standard
Product Prices for all of the Sites for the upcoming Calendar
Year, and (B) the projected Blended Price for the upcoming
Calendar Year. The JSC shall resolve any disputes between the
Parties with regard to the Standard Product Prices and the
projected Blended Price, and the Parties shall agree upon in
writing no later than December 1 of each Calendar Year the
Standard Product Prices for all Sites and the projected
Blended Price for the upcoming Calendar Year. The Standard
Product Prices and Blended Price shall be established in U.S.
dollars, and the Parties' finance representatives shall
negotiate in good faith to determine the exchange rate to be
used in calculating the Standard Product Prices for the BIP
Site and the BIOS Site. Each Party may enter into hedging
contracts related to currency exchange, but such contracts
will not be considered in calculation of the quarterly
settlement pursuant to Section 9.3 below.
(iv) Updating Standard Product Prices and Blended Price. Each Party
shall [*] submit to the other Party any necessary adjustments
to (a) the Standard Product Price for its Site, (b) the
quantity and timing of its purchases from the BIP Site or the
other Party's Site for the then-current Calendar Year, or (c)
the quantity of Bulk Drug Substance deriving from the Subject
Capacity at its own Site that such Party plans to manufacture
for its own use. Each Party shall make such submissions
updating such information for past, then-current, and future
Calendar Quarters in the
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then-current Calendar Year by no later than [*]. Based upon
any such updated information, the Parties shall agree upon any
updated Standard Product Prices (the "Adjusted Standard
Product Price") and projected Blended Price for the
then-ongoing Calendar Year.
(c) Example. An example of the calculation of Standard Product Prices is
set forth on Exhibit A1 attached hereto.
9.2 Purchase Price.
A Party purchasing Bulk Drug Substance from one of the Sites hereunder
during a Calendar Year shall pay the Standard Product Price applicable to
such Site and to the form of the Manufacturing Process used to manufacture
such Bulk Drug Substance (e.g., [*], the T1 Process, or the T2 Process)
for such Calendar Year, as established pursuant to Section 9.1(b)(iii)
above. Notwithstanding the foregoing, if the Standard Product Price for
Bulk Drug Substance for the BIP Site differs from the applicable price due
to BIP under the Enbrel Supply Agreement, the Party purchasing from BIP
shall pay the amount therefor set forth in the Enbrel Supply Agreement.
If, during such Calendar Year, the Standard Product Price for a Site is
adjusted pursuant to Section 9.1(b)(iv) above, the original Standard
Product Price established pursuant to Section 9.1(b)(iii) above shall
continue to apply to purchases of Bulk Drug Substance from such Site, and
settlement to the Adjusted Standard Product Price shall occur during the
quarterly settlements described in Section 9.3(b) below.
9.3 Blended Price; Quarterly Settlement.
(a) Adjustments to Projections. Within [*] following the end of each
Calendar Quarter, each Party shall submit to the other Party the
following information, if applicable and if not already submitted
pursuant to Section 9.1(b)(iv) above:
(i) Any adjustments to the quantity or price of Bulk Drug
Substance for Product that such Party purchased from BIP,
compared to the projections of such purchases that were used
in calculating the Standard Product Price for the BIP Site for
the applicable Calendar Year;
(ii) Any adjustments to the quantity of Bulk Drug Substance that
such Party purchased from the Site owned by the other Party,
or to the quantity of Bulk Drug Substance manufactured at such
Party's own Site for its own use, compared to the previous
projections of such purchases that were used in calculating
the Blended Price for the current Calendar Year; and
(iii) Any adjustments to the Fully Absorbed Manufacturing Cost for
Bulk Drug Substance manufactured at the Site owned by such
Party, or the applicable Inventory Carrying Costs, compared to
the projections made in calculating the Standard Product Price
for such Site for such Calendar Year.
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In addition, if a Party at any other time becomes aware of a
material variance in actual performance, compared to projections
used in calculating the Standard Product Price, for any of the items
set forth in Sections 9.3(a)(i)-(iii) above, then such Party shall
provide written notice to the other Party of such variance as soon
as reasonably practicable, and the JSC shall make any necessary
adjustments to the Standard Product Price and the Blended Price.
(b) Settlement to Adjusted Standard Product Price. Each Calendar
Quarter, according to the schedule set forth in Section 9.4 below,
the finance representatives designed by the Parties as set forth in
Section 9.5(b) shall settle Calendar Year-to-date purchases of Bulk
Drug Substance, made at the initial Standard Product Prices, to the
Adjusted Standard Product Prices. The settlement due from one Party
to the other Party shall be calculated by:
(i) determining the difference between (A) Calendar Year-to-date
purchases, multiplied by the Adjusted Standard Product Price,
and (B) Calendar Year-to-date purchases, multiplied by the
Standard Product Price, and
(ii) subtracting therefrom the previous Calendar Year-to-date
settlements made to the Adjusted Standard Product Price under
this Section 9.3(b).
(c) Calculation of Blended Price and Settlement. Each Calendar Quarter,
according to the schedule set forth in Section 9.4 below, the
finance representatives designated by the Parties as set forth in
Section 9.5(b) shall jointly make the following calculations.
(i) The finance representatives shall calculate the Blended Price
applicable to such Calendar Quarter, based on [*]. A separate
Blended Price shall be calculated for Bulk Drug Substance
manufactured using [*], Bulk Substance manufactured using the
T1 Process, and Bulk Drug Substance manufactured using the T2
Process, if each such Manufacturing Process is being used at
one or more Sites.
(ii) The finance representatives shall determine the settlement due
from one Party to another by calculating:
(A) the difference between (I) the cumulative Calendar
Year-to-date purchases of Bulk Drug Substance purchased
by each Party from all Sites, multiplied by the Blended
Price as calculated in Section 9.3(c)(i) above, and (II)
the cumulative Calendar Year-to-date purchases of Bulk
Drug Substance purchased by each Party from all Sites
multiplied by the applicable Adjusted Product Prices,
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(B) and subtracting therefrom the previous Calendar
Year-to-date settlements made to the Blended Price under
this Section 8.3(c).
An example of the calculation of the Blended Price Settlement is set
forth on Exhibits A2 and A3 attached hereto.
9.4 Consolidated Reporting and Forecasting.
The finance representatives designated by the Parties as set forth in
Section 9.5(b) shall jointly perform consolidated reporting for the
Collaboration. The finance representatives will provide each other with
financial information prepared in accordance with the terms contained in
this Agreement for preparation of the consolidated reports according to
the schedule set forth herein. The finance representatives shall negotiate
in good faith to resolve any issues arising during the preparation of
consolidated reports, if the issue cannot be resolved, shall refer such
dispute to the JSC. Subject to resolution of any issues by the JSC, the
consolidated reporting shall be binding on the Parties, subject to Section
11.2 below, and the Party who owes the other Party a cash settlement shall
pay the other Party the amount owed no later than [*] days following the
close of the Calendar Quarter at issue, as further set forth in Section
11.1 below.
9.5 Accounting and Financial Reporting.
(a) Reporting. Each Party shall report costs in a manner consistent with
GAAP, the terms hereof and such Party's project cost system. Each
Party's financial representative will disclose the project cost
system methodologies used, as well as any material changes thereto,
to the other Party's financial representative.
(b) Finance Representatives. Each Party shall appoint a representative
from its finance department with expertise in the areas of
accounting, cost allocation, budgeting, and financial reporting to
assist in the matters addressed by this Article 9. Each such
representative shall act as its Party's finance manager hereunder
reporting to the JSC, with authority and responsibility for
determining financial accounting and reporting methods, reports,
budgets and forecasts. Such representatives shall also provide
services to and consult with the JSC in order to address any
financial, budgetary and accounting issues that arise in connection
with each Five-Year Plan. Each Party may designate a substitute
financial representative to perform such functions temporarily or
may replace its designated financial representative at any time by
providing notice thereof to the other Party.
Article 10. Relationship with BIP, Catalytica, and Third Party Licensors
10.1 Relationship with BIP.
[*]
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10.2 Relationship with Catalytica.
The Catalytica Supply Agreement sets forth the [*]. During the term of the
Catalytica Supply Agreement, the Parties shall abide by the terms thereof
[*]. Neither Party shall take any action with Catalytica that such Party
knows would interfere with fulfillment of a Five-Year Plan established
hereunder.
10.3 Third Party Royalties.
Immunex has entered into certain license agreements that require royalties
to be paid upon sales of Product Supply Units (collectively, the "Immunex
License Agreements"). Immunex shall enter into sublicense agreements with
Wyeth, pursuant to which Wyeth will receive certain rights and licenses to
use the technology of the licensors' in the Immunex License Agreement (the
"Sublicense Agreements"). Each Sublicense Agreement will state any fees or
other obligations owed by Wyeth to Immunex in consideration for such
rights and licenses.
Article 11. Payment of Amounts Due; Audit
11.1 Payment of Amounts Due.
(a) Invoices; Payment. Each Party shall invoice the other Party for any
amounts owed pursuant to Article 9 hereunder. Subject to Section
11.1(c) below, such invoices shall be paid within [*] days after
receipt thereof. Section 9.4 shall govern the procedure for payments
between the Parties related to settlement to Blended Price; no
invoices shall be required. All payments made by the Parties
hereunder shall be made in U.S. dollars by bank wire transfer in
immediately available funds to an account designated by the Party
receiving payment.
(b) Disputes. Any disputes concerning amounts due shall be referred to
the finance representatives designated by the Parties as set forth
in Section 9.5(b). The finance representatives shall negotiate in
good faith to resolve any such disputes. If the finance
representatives are unable to resolve any disputes concerning
amounts due, they will refer such disputes to the JSC for
resolution.
(c) Late Payments. For any amounts that one Party owes to the other
Party according to Section 9.4 or 11.1(a) above, and which the
paying Party has not paid within the time period set forth in such
section, the paying Party shall increase the amount otherwise due
and payable by adding interest thereon, computed at the rate of [*]
per annum, as of the date on which payment was due.
11.2 Audits and Interim Review.
Each Party shall maintain accurate books and records in accordance with
GAAP and the terms hereof, supporting the calculation of Standard Product
Prices, Adjusted Standard Product Prices, quantities of Product purchased
and sold by such Party, Blended Prices, and amounts invoiced and paid by
such
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Party pursuant to Section 11.1 above, for [*] years following the end of
the Calendar Year to which such records pertain, or for such longer period
required by an Immunex License Agreement, provided that Immunex notifies
Wyeth of such longer period in writing. The period subject to audit will
extend for a maximum period of [*] years preceding the then current
Calendar Year. A Party, or its independent public accountants reasonably
acceptable to the other Party, may have access to the books and records
subject to audit of the other Party during normal business hours to
conduct a review or audit of such books and records, solely and to the
extent necessary to confirm the accuracy of the amounts reported and
calculated in accordance with the terms hereof; provided, however, that a
Party conducting such an audit must provide the other Party at least [*]
days' prior written notice and may not conduct such an audit more than
once in any [*] during the Term or more than once following the Term. Any
payment made by the Party being audited to the other Party as a result of
such an audit shall include interest from the date due, calculated as set
forth in Section 11.1(b) above. Any such inspection or audit shall be at
the expense of the Party conducting it; provided, however, that if such
accountants reasonably determine that the Party conducting the audit has
overpaid or underpaid the other Party by an amount equal to or greater
than [*] percent [*] in the period of time within the scope of the audit,
the other Party shall pay all reasonable fees and expenses incurred by
such accountants in making such determination. Any accounting firm
conducting such an audit shall enter into a confidentiality agreement
reasonably acceptable to both Parties limiting the disclosure and use of
information contained in such books and records. In the event that an
audit performed in accordance with this Section 11.2 does not resolve the
dispute between the Parties, then such dispute shall be referred to the
JSC pursuant to Section 3.4 above.
Article 12. Representations and Warranties; Limitation of Liabilities
12.1 Wyeth.
Wyeth hereby represents and warrants to Immunex that:
(a) Wyeth has the corporate power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder;
and
(b) Wyeth has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has been
duly executed and delivered on behalf of Wyeth, and constitutes a
legal, valid, binding obligation, enforceable against Wyeth in
accordance with its terms.
12.2 Immunex.
Immunex hereby represents and warrants to Wyeth that:
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(a) Immunex has the corporate power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder;
and
(b) Immunex has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has been
duly executed and delivered on behalf of Immunex, and constitutes a
legal, valid, binding obligation, enforceable against Immunex in
accordance with its terms.
Article 13. Indemnification
13.1 Indemnification by Immunex.
Immunex shall indemnify, defend, and hold Wyeth, its Affiliates, and its
and their respective directors, officers, employees and agents, harmless
from and against all losses, damages, liabilities, settlements, penalties,
fines, costs, and expenses (including, without limitation, reasonable
attorneys' fees and expenses) (collectively, the "Liabilities") to the
extent such Liabilities arise out of or result from (i) any claim, lawsuit
or other action by a Third Party caused by the manufacture, use, handling,
distribution, marketing, or sale of the Bulk Drug Substance, Drug Product,
Finished Product, or Product Supply in the Immunex Territory, (ii) any
material breach by Immunex of its representations, warranties, and
covenants made hereunder, and/or (iii) Immunex's grossly negligent acts or
omissions or willful misconduct. Notwithstanding the foregoing, Immunex's
indemnification obligation hereunder shall not apply to the extent that
any particular Liability arises out of or results from (y) any material
breach by Wyeth of its representations, warranties, or covenants made
hereunder, and/or (z) Wyeth's grossly negligent acts or omissions or
willful misconduct.
13.2 Indemnification by Wyeth.
Wyeth shall indemnify, defend, and hold Immunex, its Affiliates, and their
respective directors, officers, employees, and agents harmless from and
against all Liabilities arise out of or result from (i) any claim,
lawsuit, or other action by a Third Party caused by the manufacture, use,
handling, distribution, marketing, or sale of the Bulk Drug Substance,
Drug Product, Finished Product, or Product Supply in the Wyeth Territory,
(ii) any material breach by Wyeth of its representations, warranties, and
covenants made hereunder, and/or (iii) Wyeth's grossly negligent acts or
omissions or willful misconduct. Notwithstanding the foregoing, Wyeth's
indemnification obligation hereunder shall not apply to the extent that
any particular Liability arises out of or results from (y) any material
breach by Immunex of its representations, warranties, or covenants made
hereunder, and/or (z) Immunex's grossly negligent acts or omissions or
willful misconduct.
13.3 Indemnification Procedures.
A person (the "Indemnitee") which intends to claim indemnification under
Section 13.1 or 13.2 hereof shall promptly notify the Party indemnifying
hereunder (the "Indemnitor") in writing of any claim, lawsuit or other
action in
39
respect of which the Indemnitee or any of its directors, officers,
employees, agents or Affiliates intend to claim such indemnification. The
Indemnitee shall permit, and shall cause its directors, officers,
employees, agents, and Affiliates to permit, the Indemnitor, at its
discretion, to settle any such claim, lawsuit or other action and agrees
to the complete control of such defense or settlement by the Indemnitor;
provided, however, that such settlement does not adversely affect the
Indemnitee's rights hereunder or impose any obligations on the Indemnitee
in addition to those set forth herein in order for it to exercise such
rights. No such claim, lawsuit or other action shall be settled without
the prior written consent of the Indemnitor and the Indemnitor shall not
be responsible for any legal fees or other costs incurred other than as
provided herein. The Indemnitee, its directors, officers, employees,
agents and Affiliates shall cooperate fully with the Indemnitor and its
legal representatives in the investigation and defense of any claim,
lawsuit or other action covered by this indemnification. The Indemnitee
shall have the right, but not the obligation, to be represented by counsel
of its own selection and expense.
Article 14. Term and Termination
14.1 Term.
The initial term (the "Initial Term") of this Agreement shall begin as of
the Effective Date and shall continue, unless earlier terminated as set
forth in Section 14.2 below, until the later of (a) [*] years after the
Effective Date, or (b) the expiration or termination of the Enbrel Supply
Agreement. The Parties may extend this Agreement beyond the Initial Term
for periods of [*] or more (any such period, an "Additional Term"), by
mutual written agreement entered into by the Parties at least [*] years
prior to the expiration of the Initial Term or Additional Term, as
applicable. If an Additional Term is for a period of less than [*] years,
the Parties may extend the Agreement beyond such Additional Term for
periods of [*] or more by mutual written agreement entered into by the
Parties at least [*] prior to the expiration of the Additional Term. The
Initial Term plus any Additional Terms shall constitute the "Term" of this
Agreement.
14.2 Termination.
This Agreement may be terminated prior to the period set forth in Section
14.1 above as follows:
(a) Mutual Agreement. This Agreement may be terminated in its entirety
at any time upon mutual written agreement between Immunex and Wyeth
signed by a duly authorized executive officer of each Party.
(b) Material Breach.
(i) This Agreement may be terminated in its entirety by either
Immunex or Wyeth upon written notice to the other Party in the
event of a material breach by the other Party which is not
cured within [*] days from written
----------
*Confidential Treatment Requested.
40
notice to the breaching Party specifying in reasonable detail
the nature of such breach or longer if the breaching Party
delivers a certificate that such material breach is not
reasonably capable of being cured within [*] days and that the
breaching Party is working diligently to cure such breach, but
in no event shall the time for curing such breach exceed an
additional [*] days.
(ii) Except as expressly stated otherwise herein, remedies
hereunder are cumulative, and nothing in this Agreement shall
prevent either Party, in the case of a breach, from not
terminating this Agreement and seeking to enforce its rights
hereunder.
14.3 Consequences of Termination.
(a) Amounts Outstanding. Expiration or termination of this Agreement for
any reason shall not exempt either Immunex or Wyeth from paying to
the other Party any amounts due to such Party under this Agreement
and outstanding at the time of such expiration or termination.
(b) Transitional Supply Obligation. In the event of termination of this
Agreement by either Party pursuant to Section 14.2(b) above, the
breaching Party shall, at the request of the non-breaching Party,
continue to supply the Product to the non-breaching Party until such
time as a new supplier for the Product has been approved by the
applicable regulatory authorities in the non-breaching Party's
Territory; provided, however, that unless otherwise agreed upon, the
breaching Party shall not be required to supply the Product longer
than [*]. The breaching Party shall supply the non-breaching Party
with the quantities of Product that the breaching Party is obligated
to supply according to the Supply Allocation included [*].
(c) Willful Breach. In the event that either Party willfully breaches
its obligation to supply Product to the other Party in accordance
with the terms set forth in Articles 4, 5, or 6 hereof, the
non-breaching Party shall be entitled to recover its incidental,
special, and consequential damages incurred as result of such
willful breach, in addition to any other remedies that the
non-breaching Party may have at law or in equity. EXCEPT AS SET
FORTH IN THE PRECEDING SENTENCE, NEITHER PARTY SHALL HAVE THE RIGHT
TO RECOVER INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES ARISING
FROM OR RELATED TO BREACH BY THE OTHER PARTY OF THIS AGREEMENT.
14.4 Specific Performance.
The Parties agree that irreparable damage would occur in the event any
provision of this Agreement was not performed in accordance with the terms
hereof and that the Parties shall be entitled to specific performance of
the terms of this Agreement, in addition to any other remedy at law or
equity.
----------
*Confidential Treatment Requested.
41
14.5 Rights Not Exclusive.
All rights to terminate, all rights upon termination, and all rights to
seek specific performance are in addition to other remedies in law or
equity that may be available to either Party.
Article 15. Confidentiality
15.1 Confidentiality Obligations.
Except as permitted elsewhere under this Agreement, each Party agrees to
take Reasonable Steps (as defined in this Section 15.1) (a) to receive and
maintain the Confidential Information of the other Party in confidence,
(b) not to disclose such Confidential Information to any Third Party
without the written consent of the disclosing Party, and (c) to promptly
notify the disclosing Party upon learning of any law, rule, regulation, or
court order that purports to compel disclosure of any Confidential
Information of the disclosing Party and to reasonably cooperate with the
disclosing Party, at the disclosing Party's expense, in the exercise of
the disclosing Party's right to protect the confidentiality of such
Confidential Information. Neither Party hereto shall use all or any part
of the Confidential Information of the other Party for any purpose other
than to perform its obligations under this Agreement. The Parties will
take Reasonable Steps (as defined in this Section 15.1) to ensure that
their employees, representatives, and agents comply with this provision,
and will be responsible for any breach by such employees, representatives,
and agents. As used herein, "Reasonable Steps" means at least the same
degree of care that the receiving Party uses to protect its own
Confidential Information, and in, any event, no less than reasonable care.
15.2 Exclusions.
Nothing contained herein shall prevent a Party from disclosing
Confidential Information pursuant to any applicable law, rule, regulation,
or court order; provided, however, that such Party complies with the
notice provisions of Section 15.1(c) to the extent permissible under
applicable laws, rules, regulations, or court orders. Such disclosure
shall not alter the status of such information hereunder for all other
purposes as Confidential Information.
15.3 Remedies.
Each Party acknowledges and agrees that the provisions of this Article 15
are reasonable and necessary to protect the other Party's interests in its
Confidential Information, that any breach of the provisions of this
Article 15 may result in irreparable harm to such other Party, and that
the remedy at law for such breach may be inadequate. Accordingly, in the
event of any breach or threatened breach of the provisions of this Article
15 by a party hereto, the other Party, in addition to any other relief
available to it at law in equity or otherwise, shall be entitled to seek
temporary and permanent injunctive relief restraining the breaching Party
from engaging in and/or continuing any conduct that would constitute a
breach of this Article 15, without the necessity of proving actual damages
or posting a bond or other security.
42
15.4 Publications.
No announcement, news release, public statement, publication, or
presentation relating to the existence of this Agreement, the subject
matter herein, or either Party's performance hereunder (collectively, a
"Publication") shall be made without the other Party's prior approval;
provided, however, that either Party may make such Publication or
disclosure as is deemed necessary, in the reasonable judgment of the
responsible Party, to comply with federal or state laws or regulations.
Each Party agrees to submit such Publication it proposes to make to the
other Party for purposes of such other Party's review and comment or,
if required pursuant to this Section 15.4, approval. Any such
disclosure will not contain confidential business or technical
information of the other Party, unless if disclosure of such
confidential business or technical information is required by law or
regulation, in which case the disclosing Party will redact if
permissible by such law or regulation, or otherwise make reasonable
efforts to minimize such disclosure and obtain confidential treatment
for any such information which is disclosed by requirement of such law
or regulation. Except as otherwise required by such law or regulation,
the Party whose Publication has been reviewed shall consider in good
faith the removal of any information the reviewing Party reasonably
deems to be inappropriate for disclosure. Each Party further agrees to
respond as promptly as reasonably practicable to a proposed Publication
in accordance with timelines agreed upon by the Parties, and likewise
agrees that it shall not unreasonably withhold approval of such
Publication.
Article 16. Force Majeure
16.1 Effects of Force Majeure.
Neither Immunex nor Wyeth shall be in breach of this Agreement if there is
any failure of performance under this Agreement (except for payment of any
amounts due hereunder) occasioned by any act of God, fire, act of
government or state, war, civil commotion, insurrection, embargo,
prevention from or hindrance in obtaining energy or other utilities, labor
disputes of whatever nature or any other reason beyond the control and
without the fault or negligence of the Party affected thereby (a "Force
Majeure Event"). Such excuse shall continue as long as the Force Majeure
Event continues. Upon cessation of such Force Majeure Event, the affected
Party shall promptly resume performance hereunder.
16.2 Notice of Force Majeure.
Each Party agrees to give the other Party prompt written notice of the
occurrence of any Force Majeure Event, the nature thereof, and the extent
to which the affected Party will be unable fully to perform its
obligations hereunder. Each Party further agrees to use reasonable efforts
to correct the Force Majeure Event as quickly as possible and to give the
other Party prompt written notice when it is again fully able to perform
such obligations.
43
16.3 Supply Shortage Caused by Force Majeure.
If a Force Majeure Event occurs, the JSC shall determine whether it has
caused a Supply Shortage, and if so, the JSC shall make any corresponding
adjustments to the then-current Five-Year Plan.
Article 17. Assignment
17.1 Assignment.
This Agreement shall be binding upon the successors and assigns of each
Party and the name of a Party appearing herein shall be deemed to include
the names of its successors and assigns. Neither Party may assign its
interest under this Agreement without the prior written consent of the
other Party, which consent shall not be unreasonably withheld; provided,
however, that either Party may assign its interest under this Agreement,
without the prior written consent of the other Party, (a) to an Affiliate,
so long as the assigning Party unconditionally guarantees the obligations
of such Affiliate or (b) to a successor to the assigning Party's business
by reason of merger, sale of all or substantially all of its assets or
other form of acquisition, provided that such successor agrees in writing
to assume all of the obligations of the assigning Party under this
Agreement. Any purported assignment without a required consent shall be
void. No assignment shall relieve either Party of responsibility for the
performance of any obligation that accrued prior to the effective date of
such assignment.
44
Article 18. Dispute Resolution
18.1 Dispute Resolution.
The Parties recognize that a bona fide dispute as to certain matters may
from time to time arise during the term of this Agreement that relates to
a Party's rights and/or obligations hereunder. In the event of the
occurrence of such a dispute, either Party may, by written notice to the
other Party, have such dispute referred to their respective officers
designated below, or their designees, for attempted resolution by good
faith negotiations within thirty (30) days after such written notice is
received. Such designated officers are as follows:
For Immunex - Chief Operating Officer
For Wyeth - President
In the event the designated officers are not able to resolve such dispute
within such thirty (30)-day period, or such other period of time as the
Parties may mutually agree in writing, each Party shall have the right to
pursue any and all remedies available at law or in equity.
18.2 Certain Disputes. Notwithstanding the foregoing, this Article 18 shall not
apply to any disputes arising under Article 13 (Indemnification) or
Article 15 (Confidentiality) hereunder. Disputes arising under the Quality
Agreement shall be governed by the process set forth in Article 9 therein.
Article 19. Miscellaneous
19.1 Notices.
Any notice required or permitted to be given hereunder by either Party
shall be in writing and shall be (a) delivered personally, (b) sent by
registered mail, return receipt requested, postage prepaid, (c) sent by a
nationally-recognized courier service guaranteeing next-day or second day
delivery, charges prepaid, or (d) delivered by facsimile (with the
original promptly sent by any of the foregoing manners), to the addresses
or facsimile numbers of the other Party set forth below, or at such other
addresses as may from time to time be furnished by similar notice by
either Party. The effective date of any notice hereunder shall be the date
of receipt by the receiving Party.
If to Immunex: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Operating Officer
Fax: (000) 000-0000
Phone: (000) 000-0000
45
with a copy to: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
Fax: (000) 000-0000
Phone: (000) 000-0000
If to Wyeth: Wyeth-Ayerst Laboratories
000 X. Xxxxxxxxx
Xx. Xxxxxx, Xxxxxxxxxxxx 00000
Attention: Senior Vice President, Global Business
Development
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: American Home Products Corporation
Five Giralda Farms
Madison, New Jersey 07940
Attention: General Counsel
Fax: (000) 000-0000
Phone: (000) 000-0000
19.2 Applicable Law.
This Agreement shall be construed and the respective rights of the Parties
determined in accordance with the laws of the State of New Jersey, without
regard to conflicts of law. The Parties expressly exclude the application
to this Agreement of the United Nations Convention on Contracts for the
International Sale of Goods.
19.3 Headings.
The table of contents and all headings in this Agreement are for
convenience of reference only and shall not affect the interpretation of
this Agreement.
19.4 Exhibits.
All exhibits referred to herein form an integral part of this Agreement
and are incorporated into this Agreement by such reference.
19.5 Severability.
Both Parties hereby expressly agrees that they have no intention to
violate any public policy, statutory or common laws, rules, regulations,
treaty or decision of any government agency or executive body thereof of
any country or community or association of countries; that if any word,
sentence, paragraph, clause or combination thereof in this Agreement is
found by a court or executive body with judicial powers having
jurisdiction over this Agreement or either Party hereto, in a final
unappealed order, to be in violation of any such provisions in any country
or community or association of countries, such words, sentences,
paragraphs, clauses or combination shall be inoperative in such country or
community or association of countries and the remainder of this Agreement
shall remain binding upon the Parties, so long as
46
enforcement of the remainder does not violate the Parties' overall
intentions in this transaction.
19.6 Waiver.
No waiver of any term, provision or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition or of any other term, provision or condition of this Agreement.
19.7 Construction.
The Parties agree that each Party and its counsel has reviewed this
Agreement and that any rule of construction to the effect that ambiguities
are to be resolved against the drafting party shall not apply to the
interpretation of this Agreement.
19.8 Counterparts.
This Agreement and any amendment hereto may be executed in any number of
counterparts, each of which shall for all purposes be deemed to be an
original and all of which shall constitute the same instrument.
19.9 Entirety; Amendments.
This Agreement, including any exhibits attached hereto and referenced
herein, constitutes the full understanding of the Parties and a complete
and exclusive statement of the terms of their agreement with respect to
the specific subject matter hereof, and no terms, conditions,
understandings or agreements purporting to modify or vary the terms
thereof shall be binding unless it is hereafter made in writing and signed
by both Parties. The MOU is superceded by this Agreement and is of no
further force and effect. After RI Approval, the Short-Term Allocation
Agreement shall be superceded by this Agreement and shall be of no further
force and effect. No modification to this Agreement shall be effected by
the acknowledgment or acceptance of any purchase order or shipping
instruction forms or similar documents containing terms or conditions at
variance with or in addition to those set forth herein. In the event of a
conflict between this Agreement and the exhibits hereto, the terms of this
Agreement shall control. In the event of a conflict between this Agreement
and the terms of the TNFR Agreement, the terms of this Agreement shall
control. In the event of a conflict between this Agreement and the terms
of the Enbrel Supply Agreement, the terms of the Enbrel Supply Agreement
shall control. This Agreement may be amended and supplemented only by a
written instrument signed by both Parties.
[This space is intentionally left blank.]
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IN WITNESS WHEREOF, Immunex and Wyeth have caused this Agreement to be executed
as of the Effective Date.
IMMUNEX CORPORATION AMERICAN HOME PRODUCTS
CORPORATION, acting through its
Wyeth-Ayerst Laboratories division
By: /s/ Xxxxx X. Xxxx By: /s/ Xxxxxxx X. Xxxxxx
---------------------------------- ---------------------------------
Name: Xxxxx X. Xxxx Name: Xxxxxxx X. Xxxxxx
-------------------------------- -------------------------------
Executive Vice President and
Title: Chief Financial Officer Title: Senior Vice President Finance
------------------------------- ------------------------------
Date: November 6, 2001 Date: November 6, 2001
-------------------------------- -------------------------------
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