Preview of our top selling Collaboration Agreement
American Home Products / Immunex - Collaboration And Global Supply Agreement
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 51 University Street, Seattle, Washington 98101, together with its Affiliates (collectively, "Immunex") and AMERICAN HOME PRODUCTS CORPORATION, a Delaware corporation having its corporate headquarters at Five Giralda Farms, Madison, New Jersey 07940, together with its Affiliates (collectively, "AHPC"), acting through its WYETH-AYERST PHARMACEUTICALS division, having offices at 555 East Lancaster Avenue, St. Davids, Pennsylvania 19087, 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, Dublin 22, Ireland, 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, Dublin 22, Ireland.
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, subli...
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