Exhibit 10.18
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
ENBREL SUPPLY AGREEMENT
AMONG
IMMUNEX CORPORATION,
AMERICAN HOME PRODUCTS CORPORATION
AND
BOEHRINGER INGELHEIM PHARMA KG
DATED AS OF NOVEMBER 5, 1998
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
67
TABLE OF CONTENTS
PAGE
ARTICLE 1. DEFINITIONS.................................................1
ARTICLE 2. COORDINATORS................................................9
ARTICLE 3. SUPPLY OF BULK DRUG SUBSTANCE, DRUG
PRODUCT AND FINISHED PRODUCT...............................10
ARTICLE 4. PRE-FIRST COMMERCIAL SALE FIRM ORDERS;
FORECASTS; FIRM ORDERS; DELIVERIES.........................13
ARTICLE 5. PRODUCTION CAPACITY; PRODUCT PRICE; PAYMENT................21
ARTICLE 6. BIP PRODUCT WARRANTIES; SPECIFICATIONS.....................26
ARTICLE 7. PACKAGING..................................................29
ARTICLE 8. CLAIMS.....................................................29
ARTICLE 9. MANUFACTURING AUDITS; CERTIFICATE OF
COMPLIANCE; REGULATORY MATTERS.............................30
ARTICLE 10. RECALLS....................................................34
ARTICLE 11. QUALITY ASSURANCE; QUALITY CONTROL;
VALIDATION; STABILITY......................................35
ARTICLE 12. BIP'S OBLIGATIONS AS MANUFACTURER..........................37
ARTICLE 13. LICENSE GRANTS.............................................40
ARTICLE 14. USE OF DATA; OWNERSHIP OF INTELLECTUAL
PROPERTY; [*]; FUTURE ACTIVITIES...........................41
ARTICLE 15. REPRESENTATIONS AND WARRANTIES.............................41
ARTICLE 16. INDEMNIFICATION............................................42
ARTICLE 17. CONFIDENTIALITY............................................44
ARTICLE 18. PRESS RELEASES; USE OF NAMES...............................47
68
PAGE
ARTICLE 19. TERM; TERMINATION..........................................47
ARTICLE 20. FORCE MAJEURE..............................................52
ARTICLE 21. ASSIGNMENT.................................................54
ARTICLE 22. DISPUTE RESOLUTION.........................................54
ARTICLE 23. MISCELLANEOUS..............................................55
EXHIBITS:
EXHIBIT A BULK DRUG SUBSTANCE SPECIFICATIONS
EXHIBIT B DRUG PRODUCT SPECIFICATIONS
EXHIBIT C FINISHED PRODUCT SPECIFICATIONS
EXHIBIT D VOLUME DISCOUNT PRICING MATRIX FOR BULK DRUG SUBSTANCE [*]
EXHIBIT E VOLUME DISCOUNT PRICING MATRIX FOR FILLING AND LYOPHILIZATION
OPERATIONS FOR [*]
EXHIBIT F VOLUME DISCOUNT PRICING MATRIX FOR LABELING OPERATIONS FOR [*]
EXHIBIT G FIRM ORDER PLANNING SYSTEM OF [*] COMMERCIAL SUPPLY, PRE-FDA
APPROVAL
EXHIBIT H COORDINATORS AND WYETH REPRESENTATIVE
69
ENBREL SUPPLY AGREEMENT
THIS ENBREL SUPPLY AGREEMENT ("AGREEMENT") is made effective as of November 5,
1998, by and among IMMUNEX CORPORATION, a corporation of the State of
Washington, having its principal place of business at 00 Xxxxxxxxxx Xxxxxx,
Xxxxxxx, Xxxxxxxxxx 00000, U.S.A., together with its Affiliates (as defined
herein) ("IMMUNEX"), AMERICAN HOME PRODUCTS CORPORATION, a corporation of the
State of Delaware having its corporate headquarters at Five Xxxxxxx Xxxxx,
Xxxxxxx, Xxx Xxxxxx 00000, X.X.X. ("AHPC"), acting through its Wyeth-Ayerst
Laboratories division, having offices at 000 Xxxx Xxxxxxxxx Xxxxxx, Xx. Xxxxxx,
Xxxxxxxxxxxx 00000, X.X.X. ("WYETH"), and BOEHRINGER INGELHEIM PHARMA KG (the
successor of Xx. Xxxx Xxxxxx GmbH ("XXXXXX")), a German corporation having a
place of business at Birkendorfer Stra(beta)e 65, 88397 Biberach an der Riss,
Federal Republic of Germany ("BIP").
BACKGROUND
Immunex and Wyeth wish to distribute commercially in their respective
territories a certain Immunex proprietary biological product known as TNFR:Fc
in finished dosage form for human use.
BIP has the experience and expertise necessary to perform manufacturing,
analytical testing and quality assurance services for the manufacturing and
labeling of such product for sale hereunder, and BIP owns specialized cell
culture, processing, protein purification, filling and lyophilization
facilities that are suitable for commercial production of such product.
Immunex and Wyeth desire BIP to perform such services and sell commercial
quantities of such product hereunder, and BIP desires to perform such services
and sell commercial quantities of such product to Immunex on its behalf and on
behalf of Wyeth hereunder, all on the terms and conditions set forth in this
Agreement.
AGREEMENT
IN CONSIDERATION OF the mutual covenants set forth in this Agreement, the
Parties (as defined herein) hereby agree as follows:
ARTICLE 1. DEFINITIONS
The following terms, whether used in the singular or plural, shall have the
meanings assigned to them below for purposes of this Agreement.
1.1 "ACQUISITION COST" shall mean the actual invoiced price paid by a Party to
any Third Party (as defined herein) for acquiring any materials used in the
manufacture of the Product (as defined herein) hereunder, including, but
not limited to, shipping and handling costs and customs duties incurred and
paid by such Party in connection with the acquisition of such materials,
and also including [*] percent ([*]%) of the above amounts to cover such
Party's storage and overhead costs. This definition, including the [*]
percent ([*]%) markup, shall only apply in the circumstances set forth in
Section 6.3(a)(5) and Section 19.3(c)(1) hereof.
1.2 "AFFILIATE" shall mean any corporation or business entity of which a Party
owns directly or indirectly, fifty percent (50%) or more of the assets or
outstanding stock, or any corporation which a Party directly or indirectly
controls, or any parent corporation that owns, directly or indirectly,
fifty percent (50%) or more of the assets or outstanding stock of a Party
or directly or indirectly controls a Party. For purposes of this Agreement,
any Party and the other Affiliates it controls shall not be deemed to be
Affiliates of any other Party.
1.3 "ANNUAL QUANTITY" shall mean the number of kg of Bulk Drug Substance (as
defined herein) for which Buyer (as defined herein) has submitted Firm
Orders (as defined herein) with respect to a particular Calendar Year (as
defined herein).
1.4 "ANNUAL SURCHARGE" shall have the meaning set forth in Section 5.2(b)
hereof.
70
1.5 "BIP CONFIDENTIAL INFORMATION" shall mean all technical and other
information relating to the Biberach Facility (as defined herein) and
associated BIP technologies that are disclosed or supplied to, or used on
behalf of (as recorded in relevant BIP documentation), Immunex and/or Wyeth
by BIP pursuant to this Agreement, whether patented or unpatented,
including, without limitation, trade secrets, know-how, processes,
concepts, ideas, experimental methods and results and business and
scientific plans.
1.6 "BLA" shall mean a biologics license application, or any successor filing
thereto with the FDA (as defined herein) that generally replaces a
biologics license application.
1.7 "BATCH" shall mean (a) with respect to Bulk Drug Substance, a Bulk Drug
Substance Lot (as defined herein), (b) with respect to Drug Product (as
defined herein), a Large Lyophilization Chamber Lot (as defined herein),
(c) with respect to Finished Product (as defined herein), a Large
Lyophilization Chamber Lot, or (d) any other size batch as agreed to by the
Parties in writing from time to time.
1.8 "BIBERACH FACILITY" shall mean (a) BIP's facility at Birkendorfer
Stra(beta)e 65, 88397 Biberach an der Riss, Federal Republic of Germany, at
which the Product is manufactured (the "ORIGINAL BIBERACH FACILITY") or (b)
such other facility of BIP or a BIP Affiliate at which the Product is
manufactured, provided, however, BIP's manufacturing of the Product may not
be transferred from the Original Biberach Facility without the prior
written approval of Immunex and Wyeth, and provided further, that any
transfer of production of the Product from the Original Biberach Facility
to any other Biberach Facility shall be permitted only to the extent that
such transfer is approved by all applicable regulatory authorities and the
possible interference and any resulting delay in BIP's performance of its
obligations hereunder, as well as any impact on the Product Price (as
defined herein), are agreed upon by the Parties.
1.9 "BULK DRUG SUBSTANCE" shall mean [*] Product (as defined herein) [*] which
has been purified to a concentrated form from one or more Bulk Drug
Substance Lots and can be stored in a liquid or frozen form under
appropriate conditions. [*]
1.10 "BULK DRUG SUBSTANCE LOT" shall mean a single [*] ([*]) L fermentation
scale lot of purified Product, processed to result in Bulk Drug Substance,
which lot shall be manufactured in compliance with cGMP (as defined herein)
and in conformance with the Bulk Drug Substance Specifications (as defined
herein).
1.11 "BULK DRUG SUBSTANCE RUN" shall mean a single run of the Process (as
defined herein) at the [*] ([*]) L fermentation scale, which run is
calculated to result in a Bulk Drug Substance Lot.
1.12 "BULK DRUG SUBSTANCE SPECIFICATIONS" shall mean specifications developed by
Immunex and Wyeth as set forth in the Product BLA for Bulk Drug Substance
which describe testing methods and acceptance criteria for each Bulk Drug
Substance Lot generated, and which are attached hereto as EXHIBIT A, as
such specifications may be amended from time to time by mutual agreement of
the Parties, including without limitation such amendments as may be
required to obtain approval of the Drug Product from the FDA, EMEA (as
defined herein) and other applicable regulatory authorities in the
Territory (as defined herein). BIP shall not unreasonably withhold its
agreement to such specification amendments after agreement of the Parties
on the commercial impact of any such amendments.
1.13 "BUYER" shall mean Immunex; provided, however, that Buyer shall mean Wyeth
if (a) this Agreement is terminated solely with respect to the Immunex
Territory (as defined herein) for any reason, or (b) Immunex or its
permitted successor(s) is no longer a party to this Agreement for any
reason.
1.14 "CGMP" shall mean the regulatory requirements for current good
manufacturing practices promulgated by the FDA under the FD&C Act (as
defined herein), 21 C.F.R. ss. 210 ET SEQ. and under the PHS Act (as
defined herein), 21 C.F.R. xx.xx. 600-610, or the applicable regulatory
guidance documents promulgated by the EMEA, as the case may be, as the same
may be amended from time to time.
1.15 "CALENDAR QUARTER" shall mean each three (3)-month period commencing the
first day of January, April, July and October of each Calendar Year.
71
1.16 "CALENDAR YEAR" shall mean each twelve (12)-month period commencing January
1st of each year during the Supply Term (as defined herein) through the end
of the Supply Term. The obligations of the Parties with respect to the
Maximum Request (as defined herein), Annual Quantity, Product Price, Annual
Surcharge and other applicable terms hereunder shall be prorated during
1998 and during the last year of the Supply Term to reflect that such years
during the Supply Term may be shorter than a full twelve (12)-month year.
1.17 "CELL LINE" shall mean a proprietary Immunex Chinese Hamster Ovary ("CHO")
cell line that expresses the Product. [*].
1.18 "CERTIFICATE OF ANALYSIS" shall mean a document listing the date of
manufacturing, tests performed, specifications, test date(s), and test
results, including photographs and chromatograms as applicable, as required
by the Bulk Drug Substance Specifications, the Drug Product Specifications
(as defined herein) and the Finished Product Specifications (as defined
herein), as the case may be, the accuracy of which has been certified by a
Party. The Parties shall from time to time agree upon a format or formats
for the Certificate of Analysis to be used hereunder.
1.19 "CERTIFICATE OF COMPLIANCE" shall mean a document (a) listing the
expiration date and quantity of a particular Batch of Bulk Drug Substance,
Drug Product and/or Finished Product, (b) certifying that such Batch was
manufactured in accordance with all Specifications (as defined herein),
cGMP, the BLA/EMEA-dossier for the Product (as applicable), and all
applicable FDA and EMEA regulations, and (c) certifying that such Batch is
acceptable for release. The Parties shall from time to time agree upon a
format or formats for the Certificate of Compliance to be used hereunder.
1.20 "CONFIDENTIAL INFORMATION" shall mean Immunex/Wyeth Confidential
Information (as defined herein) or BIP Confidential Information, as the
context requires.
1.21 "CONTRACT YEAR" shall mean the period of twelve (12) consecutive calendar
months commencing on the first day of the month following First Commercial
Sale (as defined herein).
1.22 "DELIVERY DATE" shall mean a date for which delivery of Bulk Drug
Substance, Drug Product and/or Finished Product, as the case may be, is
stated in a Firm Order.
1.23 "DELIVERY DATE CONFIRMATION" shall mean a written confirmation sent by BIP
to Buyer confirming the Delivery Dates specified in Firm Orders issued
hereunder.
1.24 "DETAILED FORECAST SCHEDULE" shall have the meaning set forth in Section
4.3(a) hereof.
1.25 "DRUG PRODUCT" shall mean Bulk Drug Substance which has been appropriately
formulated, compounded, filled into containers and lyophilized ([*]) by BIP
without labeling ([*]).
1.26 "DRUG PRODUCT SPECIFICATIONS" shall mean specifications developed by
Immunex and Wyeth as set forth in the Product BLA that describe testing
methods and acceptance criteria for Drug Product, as well as in-process
specifications, and which are attached hereto as EXHIBIT B, as such
specifications may be amended from time to time by mutual agreement of the
Parties, including without limitation such amendments as may be required to
obtain approval of the Drug Product from the FDA, EMEA and other regulatory
authorities in the Territory. BIP shall not unreasonably withhold its
agreement to such specification amendments after agreement of the Parties
on the commercial impact of any such amendments.
1.27 "EMEA" shall mean the European Medicines Evaluation Agency, or any
successor agency.
1.28 "EMEA-DOSSIER" shall mean an application-filing for registration with the
EMEA, or any successor filing thereto with the EMEA that generally replaces
such dossier.
72
1.29 "EFFECTIVE DATE" shall mean the date first above written, which shall be
the effective date of this Agreement.
1.30 "FD&C ACT" shall mean the United States Federal Food, Drug and Cosmetic
Act, as the same may be amended from time to time.
1.31 "FDA" shall mean the United States Food and Drug Administration, or any
successor agency.
1.32 "FINISHED PRODUCT" shall mean Bulk Drug Substance which has been
appropriately formulated, compounded, filled into containers, lyophilized
([*]) and labeled by BIP, suitable for shipment in bulk packaging to
Immunex, Wyeth and/or their respective designee(s) for final commercial
packaging.
1.33 "FINISHED PRODUCT SPECIFICATIONS" shall mean specifications developed by
Immunex and Wyeth as set forth in the Product BLA that describe testing
methods and acceptance criteria for Finished Product, and which are
attached hereto as EXHIBIT C, as such specifications may be amended from
time to time by mutual agreement of the Parties, including without
limitation such amendments as may be required to obtain approval of the
Finished Product from the FDA, EMEA and other regulatory authorities in the
Territory. BIP shall not unreasonably withhold its agreement to such
specification amendments after agreement of the Parties on the commercial
impact of any such amendments.
1.34 "FIRM ORDER" shall mean (a) the binding and partly binding portions of each
Rolling Forecast Planning Schedule (as defined herein) for Bulk Drug
Substance submitted by Buyer hereunder in accordance with Section 4.2(b)
hereof, (b) the binding portion of each Detailed Forecast Schedule for Bulk
Drug Substance, Drug Product and/or Finished Product submitted by Buyer
hereunder in accordance with Section 4.3(c) hereof, and (c) any separate
order agreed upon in writing by Buyer and BIP that is specified as a firm
order, which on receipt thereof by BIP shall constitute a binding order in
accordance with the terms set forth in Article 4 hereof for Bulk Drug
Substance, Drug Product and/or Finished Product, as set forth in such
Rolling Forecast Planning Schedule, Detailed Forecast Schedule, or written
separate order, as the case may be.
1.35 "FIRST COMMERCIAL SALE" shall mean November 4, 1998, the date of the first
commercial sale of Finished Product following regulatory approval of the
Product by the FDA.
1.36 [*]
1.37 [*]
1.38 "IMMUNEX/WYETH CONFIDENTIAL INFORMATION" shall mean the Cell Line, Master
Cell Bank (as defined herein), Working Cell Bank (as defined herein),
Process, [*] Product, [*], and all technical and other information relating
thereto that is disclosed or supplied to BIP by Immunex and/or Wyeth
pursuant to this Agreement, whether patented or unpatented, including,
without limitation, trade secrets, know-how, processes, concepts, ideas,
experimental methods and results and business and scientific plans.
1.39 "IMMUNEX TERRITORY" shall mean the U.S. (as defined herein) and Canada.
1.40 "LARGE LYOPHILIZATION CHAMBER LOT" shall mean, with respect to the
lyophilization cycles of Bulk Drug Substance to be completed by BIP
hereunder in converting Bulk Drug Substance to Drug Product or Finished
Product, a large scale lyophilization chamber lot with a maximum capacity
of [*] ([*]) 2R (4 ml) vials, and with an average yield of [*] ([*]) 2R (4
ml) vials. The Parties agree that, consistent with standard operating
procedures agreed upon by Buyer and BIP from time to time, pooling and
splitting of Bulk Drug Substance by BIP will be allowed if feasible to
support maximizing any Large Lyophilization Chamber Lot cycles.
1.41 "MASTER CELL BANK" shall mean Immunex's reference deposit or collection of
vials of the Cell Line, from which the Working Cell Bank is derived.
73
1.42 "MAXIMUM REQUEST" shall mean that quantity of Bulk Drug Substance [*] in
accordance with Section 5.1(a) - (c) hereof.
1.43 "MINIMUM QUANTITY" shall mean [*] percent ([*]%) of the Maximum Request.
1.44 "PHS ACT" shall mean the Public Health Service Act, Biological Products,
as amended, as the same may be amended from time to time.
1.45 "PARTY" or "PARTIES" shall mean BIP, Immunex and/or Wyeth, as the context
requires.
1.46 "PHASE I AGREEMENT" shall mean the Contract Research Agreement Feasibility
Study for Evaluation of TNFR:Fc Process (Phase I) among Immunex, AHPC and
Xxxxxx effective as of August 1, 1996.
1.47 "PHASE I PROJECT" shall mean the Phase I contract research program
described in the Phase I Agreement, in which Immunex transferred the
Process to Xxxxxx to be implemented, scaled-up and evaluated at the [*]
([*]) L fermentation scale in the Biberach Facility.
1.48 "PHASE II AGREEMENT" shall mean the Production Scale-Up Agreement: TNFR:Fc
Process (Phase II) among Immunex, AHPC and Xxxxxx effective as of April 1,
1997.
1.49 "PHASE II PROJECT" shall mean the Phase II scale-up program described in
the Phase II Agreement. The primary objectives of the Phase II Project were
for Xxxxxx to scale-up the Process from the [*] ([*]) L fermentation scale
to the [*] ([*]) L fermentation scale at the Original Biberach Facility,
including down stream processing, to complete [*] ([*]) Bulk Drug Substance
Lots, and to convert the Bulk Drug Substance from such [*] ([*]) Bulk Drug
Substance Lots to Drug Product and/or Finished Product.
1.50 [*]
1.51 "PRODUCT" shall mean the pharmaceutical product TNFR:Fc, [*].
1.52 "PRODUCT PRICE" shall mean the prices for [*] Product as determined in
accordance with the terms of this Agreement.
1.53 "PRODUCTION ASSUMPTIONS" shall mean the fermentation crude Product titer
(mg/L) and purification yield assumptions with respect to a Bulk Drug
Substance Lot, as set forth in Section 5.3(a) hereof, as such Production
Assumptions may be adjusted in accordance with Section 5.3(b) and (c)
hereof.
1.54 "ROLLING FORECAST PLANNING SCHEDULE" shall have the meaning set forth in
Section 4.2 hereof.
1.55 [*]
1.56 [*]
1.57 "SPECIFICATIONS" shall mean the Bulk Drug Substance Specifications, the
Drug Product Specifications and the Finished Product Specifications, as the
context requires.
1.58 "SUPPLY TERM" shall have the meaning set forth in Section 19.1 hereof.
1.59 [*]
1.60 "TERRITORY" shall mean all countries of the world.
1.61 "THIRD PARTY" shall mean any party other than Immunex, Wyeth, BIP and their
respective Affiliates.
1.62 "U.S." shall mean the United States of America, its territories and
possessions, and the Commonwealth of Puerto Rico.
74
1.63 "UNIT" shall mean a 2R (4 ml) vial containing either (a) [*] ([*]) mg or
(b) twenty-five (25) mg of Drug Product or Finished Product, as the case
may be. Other presentations as requested hereunder in writing from time to
time by Immunex after consultation with Wyeth shall be agreed upon in
writing with BIP.
1.64 "WORKING CELL BANK" shall mean a vialed collection of serially
subcultivated cells generated by Immunex and/or BIP that is derived from
the Master Cell Bank. The Working Cell Bank is used to establish seed
cultures of the Cell Line to initiate the Process.
1.65 "WYETH TERRITORY" shall mean all of the countries of the world outside of
the Immunex Territory.
1.66 Each of the following definitions are found in the body of this Agreement
as indicated:
SECTION
"ACCEPTED UNUSED CAPACITY" 5.1(a)(3)
"ADDITIONAL MANUFACTURING CAPACITY" 3.3(a)
"ADDITIONAL MANUFACTURING CAPACITY PLAN" 3.3(d)
"ANNUAL AUDIT" 9.1(a)
"BUSINESS COORDINATORS" 2.1(a)
"CMC" 12.6(a)(2)
"DATE OF SHIPMENT" 4.5(a)(4)
"EURO" 5.9
"EVENT AUDIT" 9.1(b)(2)
"FORCE MAJEURE EVENT" 20.1
"INDEMNITEE" 16.3(a)
"INDEMNITOR" 16.3(a)
"LIABILITIES" 16.1(a)
"REGULATORY FILING GROUP" 12.6(c)
"TECHNICAL COORDINATORS" 2.1(a)
"THIRD PARTY VENDORS" 6.3(c)
"WARNING LETTER" 9.1(b)(2)(i)
"WYETH REPRESENTATIVE" 2.1(b)
ARTICLE 2. COORDINATORS
2.1 APPOINTMENT OF COORDINATORS AND WYETH REPRESENTATIVE.
(a) COORDINATORS. Buyer and BIP shall each appoint an authorized business
representative and a backup business representative ("BUSINESS
COORDINATORS"). In addition, Buyer and BIP shall each appoint an
authorized technical representative and a backup technical
representative ("TECHNICAL COORDINATORS"). The initial Business
Coordinators and Technical Coordinators are listed on EXHIBIT H
attached hereto and made a part hereof. Buyer and BIP may each replace
their respective Business Coordinators and Technical Coordinators at
any time for any reason by providing written notice thereof to the
other Parties.
(b) WYETH REPRESENTATIVE. Wyeth shall appoint a Wyeth representative and a
backup Wyeth representative (collectively, the "WYETH
REPRESENTATIVE"), which representative shall receive all notices other
than legal notices which are required or permitted to be given to
Wyeth under this Agreement. The initial Wyeth Representative is listed
on EXHIBIT H hereto. Wyeth may replace its Wyeth Representative at any
time for any reason by providing written notice thereof to the other
Parties.
2.2 RESPONSIBILITY OF COORDINATORS.
(a) BUSINESS COORDINATORS. The Business Coordinators shall be responsible
for communications, other than legal notices, between the Parties
related to forecasts, Firm Orders and deliveries of Bulk Drug
Substance, Drug Product and Finished Product hereunder, and other
matters related thereto.
75
(b) TECHNICAL COORDINATORS. The Technical Coordinators shall be
responsible for communications, other than legal notices, between the
Parties in matters of quality, manufacturing, project management and
compliance with respect to Bulk Drug Substance, Drug Product and
Finished Product, and other matters related thereto. [*]
(c) COMMUNICATIONS. Both the Business Coordinators and the Technical
Coordinators will be available on a regular basis for consultation at
pre-arranged times during the course of the Supply Term. Additional
modes or methods of communication and decision making may be
implemented as set forth herein and as agreed upon by the Parties from
time to time. As agreed upon by the applicable Coordinators and/or by
the applicable BIP Coordinator(s) and the Wyeth Representative from
time to time, BIP shall allow the Buyer Technical Coordinator and a
reasonable number of other appropriate Immunex and Wyeth personnel to
be present in BIP's facilities at agreed upon times during the Supply
Term. While at any BIP facility, the Buyer Business Coordinator, Buyer
Technical Coordinator and any other Immunex and Wyeth personnel shall
comply with all applicable BIP security and safety policies and
procedures.
ARTICLE 3. SUPPLY OF BULK DRUG SUBSTANCE, DRUG PRODUCT AND FINISHED PRODUCT
3.1 MANUFACTURE AND SUPPLY OF BULK DRUG SUBSTANCE, DRUG PRODUCT AND FINISHED
PRODUCT.
(a) BULK DRUG SUBSTANCE; DRUG PRODUCT.
(1) During the Supply Term, BIP shall [*] manufacture and sell, and
Buyer shall [*] on its behalf purchase, in each case within the
Maximum Request, Bulk Drug Substance and Drug Product, and Buyer
shall on behalf of Wyeth issue Firm Orders to BIP for Bulk Drug
Substance and Drug Product for payment by Wyeth to BIP, subject
to the terms and conditions of this Agreement, for sale or other
distribution in the Territory.
(2) From time to time during the Supply Term, and within the
provisions of the Rolling Forecast Planning Schedule and the
Detailed Forecast Schedule set forth in Section 4.2 and 4.3
hereof, respectively, Buyer reserves the option to purchase, and
in such event BIP shall manufacture and sell, Bulk Drug Substance
for delivery to Immunex, Wyeth, or/or their respective designee,
for final fill and finish by a party other than BIP. Unless
otherwise agreed by BIP, Buyer shall not purchase more than [*]
percent ([*]%) of its requirements of Product in the form of such
separate purchases of Bulk Drug Substance. The foregoing
provision shall not apply to purchases of Bulk Drug Substance
hereunder to be stored by BIP and that BIP will subsequently
convert to Drug Product and/or Finished Product.
(b) FINISHED PRODUCT. Buyer shall have the option from time to time (and
within the provisions of the Detailed Forecast Schedule) during the
Supply Term to purchase Finished Product from BIP, and BIP shall in
such event manufacture and sell, and Buyer shall on its behalf
purchase, Finished Product, and Buyer shall on behalf of Wyeth issue
Firm Orders to BIP for Finished Product for payment by Wyeth to BIP,
subject to the terms and conditions of this Agreement, for sale or
other distribution in the Territory.
(c) SPECIFICATIONS; CGMP. All Bulk Drug Substance, Drug Product and
Finished Product manufactured by BIP hereunder shall conform to the
Specifications applicable thereto and be manufactured in compliance
with cGMP.
3.2 BACK-UP SUPPLIER(S) OF BULK DRUG SUBSTANCE AND/OR DRUG PRODUCT. Immunex and
Wyeth shall together have the right to solicit estimates from and qualify
for FDA, EMEA or other regulatory authority approval one or more back-up
suppliers to manufacture and supply Bulk Drug Substance and/or Drug Product
to Buyer for sale in the Territory, and to perform any other services
assigned to BIP hereunder in the event that at any time during the Supply
Term [*]. In such event, Buyer may purchase such additional quantities of
Bulk Drug Substance and/or Drug Product in excess of the quantities BIP is
able to supply Buyer pursuant to this Agreement from such alternative
back-up supplier(s), or Buyer may manufacture such quantities itself. If
and when Buyer purchases or intends to
76
purchase from any such alternative back-up supplier(s), the Maximum Request
may not be adjusted downward by Buyer in connection therewith. [*]
3.3 RIGHT OF FIRST REFUSAL FOR ADDITIONAL MANUFACTURING CAPACITY.
(a) CONDITION PRECEDENT TO RIGHT OF FIRST REFUSAL. In the event that at
any time during the Supply Term, BIP is unable to supply all of
Immunex's and Wyeth's requirements of Bulk Drug Substance and/or Drug
Product in excess of the Maximum Request for sale in the Territory,
and Immunex and Wyeth make a determination that they will need
additional manufacturing capacity in excess of the Maximum Request (as
of the Effective Date) for Bulk Drug Substance and/or Drug Product for
an extended period (the "ADDITIONAL MANUFACTURING CAPACITY"), Immunex
and Wyeth shall, subject to Section 3.2 above, offer BIP all rights to
provide such Additional Manufacturing Capacity in accordance with the
terms set forth in this Section 3.3.
(b) NOTICE REQUIREMENTS. Immunex and Wyeth shall provide written notice to
the BIP Business Coordinator of any such determination with respect to
Additional Manufacturing Capacity as set forth in Section 3.3(a)
above. Such notice shall include sufficient information to enable BIP
to reasonably evaluate its ability to provide Immunex and Wyeth such
Additional Manufacturing Capacity, including, but not limited to, the
number of additional kilos of Bulk Drug Substance and/or the number of
additional Units of Drug Product required per Calendar Year, a
proposed timeline for providing such Additional Manufacturing Capacity
that is reasonable under the circumstances, the length of time that
Immunex and Wyeth would be prepared to commit to use an acceptable
percentage of such Additional Manufacturing Capacity, and any other
pertinent terms.
(c) COMMENCEMENT OF TIME PERIOD. Upon BIP's receipt of such notice from
Immunex and Wyeth pursuant to Section 3.3(b) above, the Parties shall
have a period of [*] ([*]) days in which to establish mutually
acceptable terms and conditions under which BIP shall build or
otherwise acquire the Additional Manufacturing Capacity, including,
but not limited to, acceptable timelines for engineering and
construction of new or expanded manufacturing facilities, the actual
production capacity to be committed by BIP to Immunex and Wyeth, the
Product Price for such additional quantities of Bulk Drug Substance
and/or Drug Product, the level of commitment to BIP required by
Immunex and Wyeth after such Additional Manufacturing Capacity is
built and qualified, and any other pertinent terms. If the Parties are
able to establish mutually acceptable terms and conditions governing
such Additional Manufacturing Capacity under this Section 3.3(c), then
the Parties shall as soon thereafter as practicable negotiate in good
faith an addendum to this Agreement to cover any changes in this
Agreement as a result of such Additional Manufacturing Capacity,
including, but not limited to, the items described in the immediately
preceding sentence.
At the end of the [*] ([*])-day period referred to in this Section
3.3(c), as such period may be extended by mutual written agreement of
the Parties, if the Parties are unable to establish mutually
acceptable terms and conditions governing such Additional
Manufacturing Capacity, Immunex and Wyeth shall have the right to
offer manufacturing rights for such Additional Manufacturing Capacity
to a Third Party or to Immunex, AHP or any of their Affiliates, on
terms that, taken as a whole, are no less favorable to Immunex and
Wyeth than the terms last offered to BIP. If Immunex and Wyeth desire
to enter into an agreement with a Third Party or between themselves
and/or their Affiliates on terms that, taken as a whole, are more
favorable to such Third Party, Immunex, AHP or any of their Affiliates
than the terms last offered to BIP, then Immunex and Wyeth shall not
enter into an agreement with such Third Party or between themselves
and/or their Affiliates unless Immunex and Wyeth first offer such new
terms to BIP. BIP shall then have [*] ([*]) days from receipt of such
additional offer to accept or reject such new terms.
77
(d) ADDITIONAL MANUFACTURING CAPACITY PLAN. BIP shall prepare and deliver
a capital investment plan for such Additional Manufacturing Capacity
(the "ADDITIONAL MANUFACTURING CAPACITY PLAN") to Immunex and Wyeth
within [*] ([*]) days after the Parties have reached any agreement
under Section 3.3(c) above. The Additional Manufacturing Capacity Plan
shall describe in reasonable detail the activities BIP proposes to
undertake and/or has already undertaken in increasing BIP's production
capacity as agreed upon by the Parties, and shall include information
regarding the expected timing of construction of the increased
capacity, and the expected timing of purchases of capital equipment
that must be specially ordered. BIP shall thereafter use all
commercially reasonable efforts to build and qualify the increased
manufacturing capacity in accordance with the timelines agreed by the
Parties. If Immunex and Wyeth can reasonably demonstrate that BIP is
failing to use all commercially reasonable efforts to build and
qualify the increased manufacturing capacity within such timelines,
Immunex and Wyeth may refer this matter to dispute resolution under
Section 22.2 hereof. If the Parties are unable to resolve such dispute
in accordance with the terms of Section 22.2 hereof, Immunex and Wyeth
shall be free to enter into an agreement with a Third Party or between
themselves and/or their Affiliates to provide such Additional
Manufacturing Capacity.
ARTICLE 4. PRE-FIRST COMMERCIAL SALE FIRM ORDERS; FORECASTS; FIRM ORDERS;
DELIVERIES
4.1 PRE-FIRST COMMERCIAL SALE -- FIRST FIVE (5) FIRM ORDERS.
(a) PRE-FIRST COMMERCIAL SALE FIRM ORDERS FOR BULK DRUG SUBSTANCE.
(1) On [*], Buyer sent a letter to BIP with respect to the first Firm
Order for Bulk Drug Substance, which letter authorized BIP to
manufacture sufficient Bulk Drug Substance required to yield [*]
([*]) twenty-five (25) mg Units of Drug Product and/or Finished
Product to be scheduled for delivery during the fourth Calendar
Quarter of 1998.
(2) On [*], Buyer sent a letter to BIP with respect to the second and
third Firm Orders for Bulk Drug Substance, which letter
authorized BIP to manufacture Bulk Drug Substance required to
yield (i) [*] ([*]) twenty-five (25) mg Units of Drug Product
and/or Finished Product to be scheduled for delivery during the
first Calendar Quarter of 1999 (second Firm Order) and [*] ([*])
twenty-five (25) mg Units of Drug Product and/or Finished Product
to be scheduled for delivery during the second Calendar Quarter
of 1999 (third Firm Order).
(3) On [*], Buyer sent a letter to BIP with respect to the fourth
Firm Order for Bulk Drug Substance, which letter authorized BIP
to manufacture Bulk Drug Substance required to yield [*] ([*])
twenty-five (25) mg Units of Drug Product and/or Finished Product
to be scheduled for delivery during the third Calendar Quarter of
1999. [*]
(4) On [*], Buyer sent a letter to BIP with respect to the fifth Firm
Order for Bulk Drug Substance, which letter authorized BIP to
manufacture Bulk Drug Substance required to yield [*] ([*])
twenty-five (25) mg Units of Drug Product and/or Finished Product
to be scheduled for delivery during the fourth Calendar Quarter
of 1999.
(5) Buyer's first five (5) Firm Orders for Bulk Drug Substance are
detailed in EXHIBIT G attached hereto. EXHIBIT G sets forth
details concerning timelines for Buyer's first five (5) Firm
Orders for Bulk Drug Substance during the period prior to First
Commercial Sale in the Immunex Territory, and timelines for
converting such Bulk Drug Substance into [*] ([*]) mg and/or
twenty-five (25) mg vials of Drug Product and/or Finished
Product. In accordance with EXHIBIT G, Buyer shall have the
flexibility in deciding when to have BIP convert Bulk Drug
Substance from such first five (5) Firm Orders into [*] ([*]) mg
and/or twenty-five (25) mg vials of Drug Product and/or Finished
Product for sale in the first five (5) Calendar Quarters after
First Commercial Sale and thereafter in the Immunex Territory,
recognizing that there is inherent uncertainty in predicting the
timing of FDA approval of the Product BLA.
78
(6) In accordance with Section 4.3 hereof, Buyer shall on a monthly
basis provide BIP with a Detailed Forecast Schedule for
converting Bulk Drug Substance from such first five (5) Firm
Orders into Drug Product and/or Finished Product. As part of each
such Detailed Forecast Schedule, Buyer shall specify the number
of [*] ([*]) mg vials and the number of twenty-five (25) mg vials
that BIP shall produce from such Bulk Drug Substance from the
first five (5) Firm Orders. Buyer's forecasted quarterly
requirements for supply of Drug Product and/or Finished Product
during the five (5) Calendar Quarters referenced in Section
4.1(a)(1) - (4) above are set forth in Table 1 below:
TABLE 1
QUARTERLY FORECASTED REQUIREMENTS OF DRUG PRODUCT AND/OR FINISHED PRODUCT FOR
FIRST FIVE CALENDAR QUARTERS AFTER FIRST COMMERCIAL SALE IN THE IMMUNEX
TERRITORY
CALENDAR QUARTER BULK DRUG SUBSTANCE REQUIRED TO
YIELD THE FOLLOWING NUMBER OF
UNITS (25 MG VIAL EQUIVALENTS)
4th Calendar Quarter 1998 [*]
1st Calendar Quarter 1999 [*]
2nd Calendar Quarter 1999 [*]
3rd Calendar Quarter 1999 [*]
4th Calendar Quarter 1999 [*]
TOTALS [*]
(b) APPLICABLE DATES. The dates applicable to (1) ordering raw materials,
(2) issuing a Firm Order for Bulk Drug Substance, (3) invoicing for
Bulk Drug Substance, (4) issuing a Firm Order date for filling
operations for converting Bulk Drug Substance into [*] ([*]) mg and/or
twenty-five (25) mg vials of Drug Product and/or Finished Product,
consistent with BIP's finite lyophilization capacity, (5) invoicing
for such filling operations, and (6) other related BIP activities with
respect to the quantities of Drug Product and/or Finished Product set
forth in Table 1 above are set forth in EXHIBIT G hereto.
(c) FIRST FIVE FIRM ORDERS GOVERNED BY THIS AGREEMENT. Upon the Effective
Date, the letters referenced in Section 4.1(a) above dated [*],
representing the first through the fifth Firm Orders, shall be deemed
to have been made hereunder and shall be superseded by this Agreement,
and the terms and conditions of this Agreement shall govern such first
through fifth Firm Orders.
4.2 POST-FIRST COMMERCIAL SALE -- THREE (3)-YEAR ROLLING FORECAST PLANNING
SCHEDULE FOR BULK DRUG SUBSTANCE.
(a) MONTHLY ROLLING FORECAST PLANNING SCHEDULE UNTIL [*]. Beginning on or
before the tenth day of each month after First Commercial Sale until
[*], or as otherwise agreed upon by BIP and Buyer, Buyer shall submit
to BIP, a three (3)-year "ROLLING FORECAST PLANNING SCHEDULE" for Bulk
Drug Substance to be manufactured by BIP. The three (3)-year period
shall be that period which commences on the first day of the [*] month
after Buyer submits each Rolling Forecast Planning Schedule. By way of
example only, when the Rolling Forecast Planning Schedule for [*] is
submitted, the three (3)-year planning horizon covered by such
schedule shall commence on [*] and shall end on [*]. Beginning in [*],
or as otherwise agreed upon by BIP and Buyer, the applicable Rolling
Forecast Planning Schedule shall be submitted on a quarterly basis as
set forth in Section 4.2(c) below.
(b) DETERMINATION OF BINDING PORTION OF EACH ROLLING FORECAST PLANNING
SCHEDULE. Each three (3)-year Rolling Forecast Planning Schedule
issued after First Commercial Sale shall be [*], as follows:
79
(1) The forecasts for Bulk Drug Substance within the [*].
(2) The forecasts for Bulk Drug Substance within the [*]. Such
forecasts within the [*] of the three (3)-year Rolling Forecast
Planning Schedule can be increased by Buyer by up to [*] percent
([*]%) by providing written notice thereof to BIP, provided that
any such increase, when added together with the forecasted
amount, shall be subject to an upper limit of either the Maximum
Request or the Maximum Request plus BIP's then-currently
available production capacity for the Product as represented by
any Accepted Unused Capacity (see Section 5.1(a)(3) hereof),
whichever upper limit is greater. Any increases above such amount
are subject to Section 4.2(d) below. The following restrictions
shall apply if such forecasts within the [*]:
(i) Within months [*] ([*]) to [*] ([*]), the forecast can be
[*] by up to [*] percent ([*]%);
(ii) Within months [*] ([*]) to [*] ([*]), the forecast can be
[*] by up to [*] percent ([*]%);
(iii) Within months [*] ([*]) to [*] ([*]), the forecast can be
[*] by up to [*] percent ([*]%); and
(iv) Within months [*] ([*]) to [*] ([*]), the forecast can be
[*] by up to [*] percent ([*]%).
[*]
(3) The forecasts for Bulk Drug Substance within the [*].
(c) QUARTERLY ROLLING FORECAST PLANNING SCHEDULE BEGINNING IN [*].
Beginning in [*], or as otherwise agreed by BIP and Buyer, Buyer shall
submit updates to the Rolling Forecast Planning Schedule on a
quarterly basis, by the tenth day of the last month of each Calendar
Quarter during the Supply Term, I.E., at June ---- 10th, September
10th, December 10th and March 10th. The three (3)-year period shall be
that period which commences on the first day of the [*] month after
Buyer submits each quarterly update to the Rolling Forecast Planning
Schedule. By way of example only, when the Rolling Forecast Planning
Schedule for [*] is submitted, the three (3)-year planning horizon
covered by such schedule shall commence on [*] and shall end on [*].
No Rolling Forecast Planning Schedule needs to be given for any period
after the expiration of the Supply Term.
(d) ADDITIONAL REQUIREMENTS OF BULK DRUG SUBSTANCE. BIP shall use all
commercially reasonable efforts to supply to Buyer any requirements of
Bulk Drug Substance which are in excess of those quantities specified
(and any increases to such quantities as permitted by Section
4.2(b)(2) above) in the then-current Rolling Forecast Planning
Schedule as set forth in Section 4.2(b)(1) and Section 4.2(b)(2)
above. BIP shall notify Buyer within thirty (30) days of receipt of
each Rolling Forecast Planning Schedule regarding BIP's ability or
inability, as the case may be, to supply Buyer's requirements of Bulk
Drug Substance in excess of those quantities specified in the
immediately preceding sentence. In addition, to the extent the Maximum
Request has been increased as set forth in Section 5.1(a)(2) hereof
for the respective period, Buyer shall be permitted to increase its
Firm Orders hereunder up to the revised Maximum Request.
80
(e) SAFETY STOCK. As soon as practicable after the Effective Date, BIP
shall endeavor at its expense to build a safety stock of [*]. The
applicable safety stock quantities will be calculated based on Buyer's
then current binding monthly Firm Orders for Bulk Drug Substance, Drug
Product and Finished Product, as applicable. BIP shall use all
commercially reasonable efforts to build any additional safety stock
of Bulk Drug Substance requested by Buyer from time to time in excess
of the [*] supply set forth in this Section 4.3(e), provided, however,
that BIP may invoice Buyer for such additional safety stock of Bulk
Drug Substance in accordance with Section 4.4(b)(1) hereof.
4.3 DETAILED FORECAST SCHEDULE FOR BULK DRUG SUBSTANCE, DRUG PRODUCT AND/OR
FINISHED PRODUCT.
(a) MONTHLY DETAILED FORECAST SCHEDULE. Beginning on the tenth day of each
month after the Effective Date, Buyer shall submit to BIP, a "DETAILED
FORECAST SCHEDULE" for (1) the number of kg of Bulk Drug Substance
(within the limitations of Section 3.1(a)(2) above), if any, and (2)
the number of Units of Drug Product and/or Finished Product, to be
delivered to Immunex, Wyeth and/or their respective designee on
Delivery Dates (by week) specified therein during the [*] period
commencing on the first day of the [*] month following, including the
allocation between [*] ([*]) mg and twenty-five (25) mg vials of Drug
Product and/or Finished Product being ordered, and also including an
allocation between the Immunex Territory and the Wyeth Territory,
respectively. By way of example only, when the Detailed Forecast
Schedule for December 10, 1998 is submitted, the [*] period covered by
such Detailed Forecast Schedule shall commence on [*] and shall end on
[*]. Except as set forth in Section 4.3(b) and (c) below, such
Detailed Forecast Schedule shall be non-binding and shall not
constitute an obligation of Buyer to purchase the quantities of Drug
Product and/or Finished Product set forth therein. With respect to
Bulk Drug Substance, such Detailed Forecast Schedule shall only serve
to provide the Delivery Dates applicable thereto, and shall not
supersede the binding portion of the then current Rolling Forecast
Planning Schedule.
(b) PRE-FIRST COMMERCIAL SALE FIRST FIVE (5) ORDERS. With respect to the
first five (5) Firm Orders issued during the pre-First Commercial Sale
period in accordance with Section 4.1 hereof, the Detailed Forecast
Schedule provided under Section 4.3(a) above shall be considered Firm
Orders in accordance with the timelines set forth in EXHIBIT G hereto.
(c) BINDING PORTION OF EACH DETAILED FORECAST SCHEDULE. Except as set
forth in Section 4.3(b) above, the first [*] ([*]) months of each [*]
([*])-month period covered by a Detailed Forecast Schedule delivered
by Buyer to BIP pursuant to Section 4.3(a) above shall be considered
Firm Orders for the quantities of Bulk Drug Substance, Drug Product
and/or Finished Product to be delivered on Delivery Dates that are
specified in such Detailed Forecast Schedule, subject to any
adjustments to such Delivery Dates as set forth in Section 4.3(d)
below. [*]
(d) DELIVERY DATE CONFIRMATIONS; SHIPPING SCHEDULE. Within [*] ([*]) days
after Buyer submits each Firm Order to BIP hereunder, BIP shall issue
a Delivery Date Confirmation confirming to Buyer in writing the
Delivery Dates specified in such Firm Order. In addition, Buyer and
BIP have agreed upon a shipping schedule with a [*] shipping horizon
for deliveries of Drug Product and/or Finished Product hereunder, as
such shipping schedule may generally be modified from time to time
upon agreement of Buyer and BIP.
(e) SUPPLY OF DRUG PRODUCT AND/OR FINISHED PRODUCT PURSUANT TO FIRM
ORDERS; ADDITIONAL REQUIREMENTS OF DRUG PRODUCT AND/OR FINISHED
PRODUCT. BIP shall convert Bulk Drug Substance to Drug Product and
deliver such Drug Product and/or Finished Product in accordance with
Firm Orders and the Delivery Dates set forth therein. Any revisions to
such Firm Orders requested by Buyer shall be negotiated between Buyer
and BIP in good faith, and BIP shall use all commercially reasonable
efforts to (1) deliver any quantities of Drug Product and/or Finished
Product in excess of those quantities specified in such Firm Orders as
directed by Buyer and (2) reallocate the mix as between the number of
Batches of Drug Product and the number of Batches of Finished Product
specified in the applicable Detailed Forecast Schedule. In addition,
and notwithstanding Section 4.3(c) above, if there is a production
shortfall under Section 4.5(b) hereof,
81
Buyer shall be permitted to reallocate its then current Detailed
Forecast Schedule between [*] ([*]) mg and twenty-five (25) mg vials
of Drug Product and/or Finished Product, as reasonably needed in order
to respond to then current market needs for the Product, and BIP shall
use all commercially reasonable efforts to accommodate such
reallocation.
(f) SHELF LIFE MANAGEMENT. When converting Bulk Drug Substance to Drug
Product hereunder, and except as otherwise agreed, BIP shall first
utilize the Bulk Drug Substance Lots with the earliest date of
manufacture in order to maximize the shelf life of Bulk Drug
Substance.
4.4 PURCHASE QUANTITIES.
(a) BATCH ORDERS; FIRM ORDERS TO SPECIFY UNITS. Except as otherwise set
forth herein or agreed upon between Buyer and BIP, all Bulk Drug
Substance, Drug Product and Finished Product ordered hereunder must be
ordered in Batch sizes or whole multiples thereof. Except as otherwise
provided in Section 4.1(a) hereof or agreed upon between Buyer and
BIP, each Firm Order for Drug Product and/or Finished Product issued
pursuant to Section 4.3 hereof shall specify the quantity of Units of
Drug Product and/or Finished Product being ordered, as well as the
allocation between [*] ([*]) mg and twenty-five (25) mg vials of Drug
Product and/or Finished Product being ordered.
(b) VARIANCES IN QUANTITIES SHIPPED; INVOICING PREREQUISITES. Quantities
actually shipped pursuant to a given Firm Order may vary from the
quantities reflected in such Firm Order by up to [*] percent ([*]%)
and still be deemed to be in compliance with such Firm Order. In
addition, with respect to each Batch that is part of a particular Firm
Order being shipped hereunder, BIP may ship and Immunex and/or Wyeth,
as the case may be depending on the destination of the applicable
shipment (I.E., Immunex for the Immunex Territory and Wyeth for
the Wyeth Territory), shall be required to pay for (in accordance with
the terms hereof) shipments of additional quantities of Drug Product
and/or Finished Product that vary by greater than [*] percent ([*]%)
from the quantities reflected in the applicable Firm Order, it being
understood that quantities of Drug Product and/or Finished Product
actually produced from each Batch will vary based on such factors as
actual success rate, fermentation crude Product titer, and
purification yield, and provided further, that BIP shall notify
Immunex in a timely manner prior to such shipment of the amount of any
such excess quantities of Drug Product and/or Finished Product being
shipped hereunder. However, Immunex and Wyeth, as applicable, shall
only be invoiced and required to pay for the quantities of Bulk Drug
Substance and Drug Product/Finished Product which (1) in the case of
Bulk Drug Substance, are accompanied by a Certificate of Analysis and
a Certificate of Compliance with respect to such Bulk Drug Substance
and (2) in the case of Drug Product/Finished Product, BIP actually
ships to Immunex, Wyeth and/or their respective designee, and are
accompanied by a Certificate of Analysis and a Certificate of
Compliance with respect to such Drug Product/Finished Product.
4.5 DELIVERIES.
(a) FILLING FIRM ORDERS; SHELF LIFE.
(1) Subject to Section 4.4(b) above, BIP shall fulfill each Firm
Order submitted pursuant to Sections 4.1, 4.2, and 4.3 hereof for
such quantities of Bulk Drug Substance, Drug Product and Finished
Product specified in such Firm Order. Drug Product and Finished
Product ordered pursuant to Sections 4.1 and 4.3 hereof shall be
delivered by each applicable Delivery Date specified in the Firm
Orders applicable thereto.
(2) Upon delivery to Immunex, Wyeth and/or their respective designee,
all Drug Product and Finished Product shall have at least the
percentage set forth in Table 2 below of its then-approved (by
the FDA or EMEA, as applicable) shelf life remaining at the "Date
of Shipment" (as defined below), provided that if the
then-approved shelf life of the Drug Product and Finished Product
is not listed in Table 2 below, then such Drug Product and
Finished Product shall have at least [*] ([*]) of its
then-approved (by the FDA or EMEA, as applicable) shelf life
remaining at the Date of Shipment. [*]
82
TABLE 2
SHELF LIFE OF DRUG PRODUCT AND FINISHED PRODUCT
SHELF LIFE MINIMUM REMAINING SHELF LIFE AT DATE OF
SHIPMENT
[*] months [*] months
[*] months [*] months
[*] months [*] months
[*] months [*] months
[*] months [*] months
(3) With respect to the "[*] months" row under the "Shelf Life"
column in Table 2 above, from and after the Effective Date and
through [*], BIP shall use all commercially reasonable efforts to
achieve a minimum remaining shelf life of Drug Product and
Finished Product at the date of shipment of [*] ([*]) months.
During such period, BIP shall use special efforts to closely
coordinate with Buyer so that the schedule for producing Batches
of Drug Product and Finished Product within the Biberach Facility
is calculated to result in a [*] ([*])-month shelf life for Drug
Product and Finished Product.
(4) For purposes of determining the date from which the shelf life of
Drug Product and Finished Product shall be calculated under this
Section 4.5(a), the term "DATE OF SHIPMENT" shall mean the
earlier of (i) the scheduled Delivery Date (subject to the terms
of Section 4.3(d) above) for a shipment of Drug Product or
Finished Product, as applicable, provided that BIP is completely
ready to ship such Drug Product or Finished Product according to
the terms hereunder on such Delivery Date and that Buyer has not
delayed taking such shipment by such Delivery Date through any
fault of BIP, or (ii) the date such shipment of Drug Product or
Finished Product, as applicable, is actually delivered to Buyer's
designated carrier(s) in Biberach/Germany.
(b) PRODUCTION SHORTFALLS; DELIVERY DELAYS. If at any time during the
Supply Term there is a shortfall or anticipated shortage of Bulk Drug
Substance, Drug Product, Finished Product, and/or any other essential
raw materials or other components used in the production of Bulk Drug
Substance, Drug Product and/or Finished Product, and/or any delay in
shipment or delivery occasioned by BIP, which shortfall or delay is
reasonably likely to result in BIP's inability to meet any Delivery
Date(s) hereunder, then BIP shall (1) immediately notify Buyer in
writing as to the reason for the shortage of supply and/or delay, and
provide an indication of the duration of the shortfall and/or delay
and (2) use all commercially reasonable efforts to allocate to Buyer
as much Bulk Drug Substance, Drug Product, Finished Product and such
essential raw materials and components as are available as a matter of
priority to meet Firm Orders issued hereunder. BIP shall not grant
higher priority to any Third Party than to Buyer with respect to such
raw materials and components. Nothing in this Section 4.5(b) releases
BIP from its obligations to supply Bulk Drug Substance, Drug Product
and Finished Product under Section 4.5(a) above. In addition, BIP
shall also promptly notify Buyer in writing when any such shortfall
and/or delay is over.
(c) DELIVERY SHORTFALLS. Unless otherwise directed in writing by Buyer
within [*] after Buyer's receipt of notice from BIP under Section
4.5(b) above that a manufacturing shortfall and/or delay as described
above is over, BIP shall use all commercially reasonable efforts to
make up all shortfalls in delivery in accordance with a Firm Order as
promptly as possible and shall promptly supply Bulk Drug Substance,
Drug Product and Finished Product (as applicable) to Immunex, Wyeth
and/or their respective designee, as appropriate, to meet such Firm
Order.
83
4.6 DELIVERY TERMS.
BIP shall arrange for shipment of Bulk Drug Substance, Drug Product or
Finished Product, as the case may be, to Immunex, Wyeth and/or their
respective designee, at the expense of the Party receiving such shipment,
and in accordance with Buyer's instructions, including instructions as to
designated carrier(s) to utilize. BIP shall not transport or ship Bulk Drug
Substance, Drug Product or Finished Product until the Party receiving such
shipment informs BIP that it has obtained all appropriate approvals and
consents of any governmental authority necessary for the transportation or
shipment of such Bulk Drug Substance, Drug Product or Finished Product, as
the case may be. BIP shall comply with all applicable German laws and
regulations regarding the transportation or shipment of Bulk Drug
Substance, Drug Product and/or Finished Product, as the case may be. Title
to, and risk of loss of, Bulk Drug Substance, Drug Product and/or Finished
Product, as the case may be, shall remain with BIP until delivery to the
designated carrier specified by Buyer in Biberach/Germany, at which time
the Party to receive such delivery shall assume title to and risk of loss
of the Bulk Drug Substance, Drug Product or the Finished Product, as the
case may be.
ARTICLE 5. PRODUCTION CAPACITY; PRODUCT PRICE; PAYMENT
5.1 PRODUCTION CAPACITY.
(a) MAXIMUM REQUEST; [*]; MILESTONE PAYMENTS.
(1) MAXIMUM REQUEST. BIP shall provide Immunex and Wyeth with
reserved production capacity, including lyophilization and
filling capacity, for Bulk Drug Substance, Drug Product and
Finished Product for the Supply Term based on the initial Maximum
Request of [*] ([*]) kg per Calendar Year, provided that Buyer
may issue Firm Orders for Bulk Drug Substance, Drug Product
and/or Finished Product greater than such amount to the extent
BIP's free available production capacity for Bulk Drug Substance,
Drug Product and/or Finished Product exceeds [*] ([*]) kg per
Calendar Year. The Parties acknowledge and agree that the initial
Maximum Request of [*] ([*]) kg of Bulk Drug Substance per
Calendar Year is based on the initial Production Assumptions set
forth in Section 5.3(a) hereof, and the assumption as of the
Effective Date that a total of [*] ([*]) Bulk Drug Substance Runs
initially reserved for Immunex and Wyeth [*]. The Parties also
understand, however, that BIP's actual production of Bulk Drug
Substance could be either more or less than [*] ([*]) kg per
Calendar Year, depending on such factors as the actual success
rate, fermentation crude Product titer, and purification yield.
(2) UPWARD ADJUSTMENTS TO MAXIMUM REQUEST.
(i) REALLOCATION OF EXISTING PRODUCTION CAPACITY. Prior to
the beginning of each Calendar Year, BIP shall inform
Buyer of any increases to the Maximum Request [*]. Any
such increases to the Maximum Request based on
allocating additional existing production capacity to
Buyer shall require mutual written agreement of the
Parties, including agreement with respect to the number
of Calendar Years for which such increase to the
Maximum Request shall be applicable, and any such
increase to the Maximum Request shall be effective as
of January 1 of the applicable new Calendar Year. After
the end of the last Calendar Year in which the Maximum
Request was increased as provided under this paragraph,
and unless otherwise agreed upon in writing by the
Parties, the Maximum Request shall automatically revert
to the level that applied immediately prior to the
effective date of such increase (I.E., the level that
was in effect prior to the first year of the applicable
---- increase under this paragraph), subject to any
downward adjustments to the Maximum Request that may
have occurred under Section 5.1(b) hereof during the
period of any such increase to the Maximum Request.
(ii) INCREASED PRODUCTION CAPACITY. In addition to potential
increases in the Maximum Request described in Section
5.1(a)(2)(i) above, the Maximum Request shall also be
subject to upward adjustment upon mutually agreed
terms, including an acceptable lead-time (E.G.,
construction of additional production capacity) (see
Section 3.3 hereof regarding Additional Manufacturing
Capacity).
84
(3) [*]
(4) [*]
(b) DOWNWARD ADJUSTMENTS TO MAXIMUM REQUEST. The Maximum Request shall be
subject to downward adjustment(s) by Immunex and Wyeth by no more than
[*] percent ([*]%) per step (except as provided below), and shall,
unless otherwise agreed by BIP, in no case result in less than [*]
([*]) kg of Bulk Drug Substance as the Maximum Request as follows: (1)
by [*] year after First Commercial Sale; (2) by [*] year after First
Commercial Sale; and (3) [*].
Notwithstanding the foregoing, to the extent that the BIP production
capacity idled as a result of any Immunex and Wyeth downward
adjustment in the Maximum Request under this Section 5.1(b) will be
utilized by BIP generally and for a sufficiently long period to
manufacture one or more biological products of Immunex, Wyeth, BIP,
any of their Affiliates or any Third Parties within the general time
period corresponding to the effective date of such downward adjustment
to the Maximum Request under Section 5.1(c) below, then the [*]
percent ([*]%) per step limitation provided above may be increased. In
such event, BIP shall provide Immunex and Wyeth with notice of the
amount of any potential percentage increase to the [*] percent ([*]%)
limit on downward adjustments in the Maximum Request that are
available to Immunex and Wyeth with respect to their most recently
exercised downward adjustment in the Maximum Request, such percentage
increase to generally be proportional to the amount of such idle BIP
production capacity that will be utilized as set forth above. Upon
request by Immunex and Wyeth, BIP shall provide Immunex and Wyeth with
accurate and complete information such as is necessary for the
calculation of any potential increase in such downward adjustment in
the Maximum Request, provided that BIP shall have no obligation to
identify the Third Parties whose products are being manufactured by
BIP, or to identify the products themselves. The Parties shall
negotiate in good faith on a case-by-case basis any potential
percentage increase to the downward adjustment in the Maximum Request
hereunder. After the completion of such negotiations, Immunex and
Wyeth shall promptly and in any event within [*] ([*]) days provide
BIP written notice regarding whether and the extent to which Immunex
and Wyeth have elected to take advantage of any such percentage
increase by making a further downward adjustment to the Maximum
Request.
(c) EFFECTIVE DATE OF DOWNWARD ADJUSTMENTS TO MAXIMUM REQUEST. Due to
BIP's lead-time necessary to make capacity adjustments, the downward
adjusted Maximum Request and the corresponding price column for Bulk
Drug Substance and Drug Product in EXHIBIT D and EXHIBIT E hereto
shall be valid from (1) [*] year after First Commercial Sale with
respect to adjustments according to Section 5.1(b)(1) above, (2) [*]
year after First Commercial Sale with respect to adjustments according
to Section 5.1(b)(2) above and (3) upon the expiration of the [*]
([*])-month notice period with respect to adjustments according to
Section 5.1(b)(3) above. By way of example only, if First Commercial
Sale of the Product occurred on December 1, 1998, and if Buyer
provides notice of a downward adjustment of the Maximum Request by [*]
year following First Commercial Sale, I.E., [*], as permitted in
Section 5.1(b)(2) above, then the ---- downward adjusted Maximum
Request and the corresponding price column for Bulk Drug Substance and
Drug Product in EXHIBIT D and EXHIBIT E hereto would be valid from
[*], which would be [*] year after First --------- ---------
Commercial Sale.
5.2 BULK DRUG SUBSTANCE PRICING; ANNUAL SURCHARGE; INVOICING.
(a) BULK DRUG SUBSTANCE PRICING. The price for the Annual Quantity of Bulk
Drug Substance is set forth in the Volume Discount Pricing Matrix for
Bulk Drug Substance [*] set forth in EXHIBIT D hereto. [*]
(b) [*]
85
(c) INVOICING IMMUNEX AND WYETH FOR BULK DRUG SUBSTANCE, DRUG PRODUCT AND
FINISHED PRODUCT. BIP may either (1) invoice Immunex ([*], as set
forth in Section 5.7(c) hereof) and Wyeth ([*]) separately for Bulk
Drug Substance in accordance with Section 4.4(b)(1) hereof, or (2)
invoice Immunex ([*], as set forth in Section 5.7(c) hereof) and Wyeth
([*]) for Drug Product or Finished Product (including the Bulk Drug
Substance component) delivered in accordance with Section 4.4(b)(2)
hereof by utilizing the pricing formulas set forth in Sections 5.4 and
5.5 hereof, respectively. If BIP chooses to invoice Immunex and Wyeth
separately for Bulk Drug Substance as set forth in (1) above, then
when BIP invoices Immunex and Wyeth for the incremental cost to
produce Drug Product or Finished Product by utilizing the pricing
formulas set forth in Sections 5.4 and 5.5 hereof, respectively, BIP
shall at the time of such invoice for Drug Product or Finished Product
issue a credit to Immunex and Wyeth, as appropriate, for an amount
which represents that portion of the cost of Bulk Drug Substance
previously paid by Immunex and Wyeth that is attributable to any
filling losses associated with filling the Drug Product or Finished
Product applicable to such invoice. By way of example only, if in
manufacturing Drug Product or Finished Product, BIP experienced a
filling loss of [*] percent ([*]%) of the Bulk Drug Substance used for
such filling, then when BIP invoices Immunex and Wyeth for the
incremental costs for such filling activities, BIP would issue a
credit to Immunex and Wyeth, as applicable, for [*] percent ([*]%) of
the cost previously paid by Immunex and Wyeth for such Bulk Drug
Substance.
5.3 ADJUSTMENT OF BULK DRUG SUBSTANCE PRICING BASED ON PRODUCTION ASSUMPTIONS.
(a) INITIAL PRODUCTION ASSUMPTIONS. The Production Assumptions shall
initially be established at a fermentation crude Product titer of [*]
([*]) mg/L and a purification yield of [*] percent ([*]%), with an
agreed upon total amount of Bulk Drug Substance yielded per Bulk Drug
Substance Lot of [*] ([*]) g. The Production Assumptions shall be
subject to an annual review and potential adjustment as set forth in
Section 5.3(b) below.
(b) [*]
(c) [*]
5.4 DRUG PRODUCT PRICING.
(a) DRUG PRODUCT PRICING. The Drug Product price per Unit (I.E., 2R (4 ml)
vial) will be calculated as follows:
[*]
(b) INITIAL DRUG PRODUCT PRICING. [*]
(c) INVOICING FOR DRUG PRODUCT. BIP may either invoice Immunex ([*], as
set forth in Section 5.7(c) hereof) and Wyeth ([*]) (1) separately for
Drug Product, including the Bulk Drug Substance component, in
accordance with the formula set forth in Section 5.4(a) above or (2)
for the incremental filling and lyophilization costs of Drug Product
as set forth in EXHIBIT E hereto, in each case in accordance with
Section 4.4(b)(2) hereof.
5.5 FINISHED PRODUCT PRICING.
(a) FINISHED PRODUCT PRICING. The Finished Product price per Unit will be
calculated by adding to the applicable Drug Product price per Unit the
applicable labeling cost per Unit in accordance with the Volume
Discount Pricing Matrix for Labeling Operations for [*] set forth in
EXHIBIT F hereto.
[*]
(b) INVOICING FOR FINISHED PRODUCT. BIP may either invoice Immunex ([*],
as set forth in Section 5.7(c) hereof) and Wyeth [*] (1) separately
for Finished Product, including the Bulk Drug Substance component, in
accordance with the formula set forth in Section 5.5(a) above or (2)
for the incremental labeling material and labeling operations costs of
Finished Product set forth in EXHIBIT F hereto, in each case in
accordance with Section 4.4(b)(2) hereof.
86
5.6 PRICE ADJUSTMENTS.
(a) ANNUAL PRODUCT PRICE ADJUSTMENT. The initial Product Price for Bulk
Drug Substance (EXHIBIT D), the incremental additional filling and
lyophilization costs for Drug Product (EXHIBIT E) and the incremental
additional labeling material and labeling operations costs for
Finished Product (EXHIBIT F) [*] may each be increased by BIP by [*]
percent ([*]%) annually beginning [*] for increasing cost of labor and
raw materials.
(b) COST INCREASES.
(1) In case any cost (in terms of cost of raw material, labor and/or
regulatory authority requirements) of producing Bulk Drug
Substance, Drug Product and/or Finished Product increases by more
than [*] percent ([*]%) in any Calendar Year, [*], the Parties
shall agree upon the direct amount of such increase based on good
faith negotiations, provided that any price increase taken by BIP
under Section 5.3(b) and/or Section 5.6(a) hereof shall be
credited toward any corresponding increase under this Section
5.6(b). The direct amount of any such increase as agreed upon
under this Section 5.6(b)(1) shall be payable by Immunex and
Wyeth pursuant to a separate BIP invoice within [*] ([*]) days
after receipt thereof.
(2) If Buyer can reasonably demonstrate to BIP that any equivalent
materials or components used for producing Bulk Drug Substance,
Drug Product and/or Finished Product can be purchased at a lower
price than BIP's cost of such materials, and that such materials
or components can be supplied on a reasonably consistent and
reliable basis, then BIP shall accept such lower price for
purposes of Section 5.6(b) and Section 5.6(c) below.
(c) [*]
5.7 PAYMENT DUE DATES; PAYMENT CURRENCY.
(a) PAYMENT DUE DATES. Subject to Section 4.4(b) hereof, the Product Price
for Bulk Drug Substance, Drug Product and/or Finished Product
delivered to Immunex, Wyeth and/or their respective designees under
this Agreement shall be payable to BIP by the Party taking delivery
within [*] ([*]) days from the date of the invoice therefor and
receipt of the related delivery.
(b) PAYMENT CURRENCY. All payments due to BIP under this Agreement shall
be made in (1) [*], as set forth in Section 5.7(c) below and (2) [*],
in each case by wire transfer to an account to be designated in
writing by BIP from time to time.
(c) [*]
5.8 RELIEF FROM ANNUAL SURCHARGE.
An Annual Surcharge shall not be payable hereunder for any Calendar Year(s)
(a) in which BIP fails to deliver Bulk Drug Substance hereunder in
sufficient quantities to fill actual Firm Orders for Bulk Drug
Substance for such Calendar Year(s),
(b) under the circumstances set forth in Section 3.2 hereof; and
(c) under the circumstances set forth in Section 20.5(b) hereof.
5.9 SHIFT FROM DEUTSCHE XXXX TO EURODOLLAR; EUROPEAN UNION EURODOLLAR
CONVERSION.
As of January 1, 1999, the "EURO" will replace the Deutsche Xxxx at the
fixed official exchange rate announced by the European Central Bank and
shall be the valid currency in Europe from that date forward. Consequently,
all amounts in this Agreement shown in Deutsche Xxxx shall be converted to
the Euro at this fixed official exchange rate and the word "Deutsche Xxxx"
or "DM" shall automatically be replaced by "Euro" throughout this
Agreement. [*].
87
ARTICLE 6. BIP PRODUCT WARRANTIES; SPECIFICATIONS
6.1 WARRANTIES BY BIP.
(a) PRODUCT WARRANTIES. BIP hereby warrants to Immunex and Wyeth that the
Bulk Drug Substance, Drug Product and Finished Product, at the time of
sale and shipment to Immunex, Wyeth and/or their respective designees
by BIP hereunder shall:
(1) with respect to Bulk Drug Substance, conform to the Bulk Drug
Substance Specifications;
(2) with respect to Drug Product, conform to the Drug Product
Specifications;
(3) with respect to Finished Product, conform to the Finished Product
Specifications;
(4) be manufactured in compliance with the requirements of cGMP;
(5) be manufactured in compliance with the requirements of all
applicable national, state and local laws, ordinances and
governmental rules and regulations of Germany and the EMEA; and
(6) be transferred free and clear of any liens or encumbrances of any
kind.
The warranties set forth in this Section 6.1 shall be continuing
warranties and shall be applicable to all Bulk Drug Substance, Drug
Product and Finished Product shipped or delivered by BIP to Immunex,
Wyeth and/or their respective designees hereunder.
(b) BIBERACH FACILITY WARRANTIES. BIP hereby warrants that it owns or
lawfully controls the Biberach Facility, [*].
6.2 DISCLAIMER BY BIP.
BIP makes no warranty that the Bulk Drug Substance, Drug Product or the
Finished Product will be merchantable or fit for any particular purpose,
nor does BIP make any other warranties with respect to the Bulk Drug
Substance, Drug Product or the Finished Product, except as expressly stated
in this Agreement.
6.3 SPECIFICATION CHANGES.
(a) SPECIFICATION CHANGES. In the event that Immunex and Wyeth wish to
change the Specifications, or in the event Immunex and Wyeth are
required to change the Specifications pursuant to applicable law, rule
or regulation or in response to the order or request of a governmental
authority or regulatory body, the following provisions will apply.
(1) Buyer shall promptly advise BIP in writing of any such change(s)
to the Specifications, and BIP shall promptly advise Buyer as to
any scheduling and/or Product Price adjustments which may result
from any such change(s), if any. The notification and approval
procedure shall be in accordance with standard operating
procedures (I.E., change control procedures) agreed upon by Buyer
and BIP from time to time.
(2) Prior to implementation of such change(s) to the Specifications,
the Parties agree to negotiate in good faith in an attempt to
reach agreement on (i) the new Product Price, if any, for any
Bulk Drug Substance, Drug Product and/or Finished Product
manufactured hereunder by BIP which embodies such change(s) to
the Specifications, giving due consideration to the effect of
such change(s) on BIP's direct manufacturing costs for Bulk Drug
Substance, Drug Product and/or Finished Product and (ii) any
other amendments to this Agreement which may be necessitated by
such changes (E.G., an adjustment to the lead time for Firm
Orders).
88
(3) Buyer will reimburse BIP for the reasonable and necessary
expenses incurred by BIP as a result of any such change(s) to the
Specifications, including, but not limited to, reimbursing BIP
for its validation and analytical development costs and capital
expenditure costs.
(4) BIP shall cooperate with Immunex and Wyeth in good faith to
implement all changes to the Specifications as soon as
practicable after notice thereof, but in any event within [*]
([*]) days' "lead time," unless otherwise agreed upon by the
Parties or required by an applicable regulatory authority. Buyer
shall not unreasonably require BIP to implement changes to the
Specifications within such [*] ([*])-day period if such changes
would typically require BIP a longer period of time to implement.
(5) If any such change(s) to the Specifications renders obsolete or
unusable any raw materials for Bulk Drug Substance or packaging
components for Drug Product or Finished Product, and to the
extent such raw materials or packaging components may not be
either returned to the appropriate vendor for a credit or
utilized by BIP for its other manufacturing operations, Buyer
shall purchase from BIP, at BIP's Acquisition Cost, that amount
of inventory of such raw materials and/or packaging components,
as the case may be, so rendered obsolete or unusable, not to
exceed the amount of such raw materials and/or packaging
components which would have been required for BIP to manufacture
and supply the total quantity of Bulk Drug Substance, Drug
Product and/or Finished Product specified in Firm Orders issued
hereunder.
(b) PROCEDURE FOR SPECIFICATION CHANGES BY BIP. BIP shall not change the
Specifications, the Process, or any test method or procedures for
manufacturing Bulk Drug Substance, Drug Product or Finished Product
without the prior written approval of the Buyer. The procedure for
deviation and change control approval shall be set forth in standard
operating procedures agreed upon by the Parties from time to time.
(c) [*]
(d) BIP RESPONSIBILITY. Notwithstanding anything herein to the contrary,
neither Immunex or Wyeth shall have any obligation to reimburse BIP
for any expenses (other than payment of the Product Price) incurred by
BIP which are related to enabling BIP to manufacturer Bulk Drug
Substance, Drug Product and Finished Product in conformance with then
current Specifications and in compliance with cGMP.
(e) POST-FDA PRODUCT APPROVAL PROCESS MODIFICATIONS.
(1) Any post-FDA Product approval modifications to the Process shall
be subject to mutual agreement of the Parties, such approval not
to be unreasonably withheld.
(2) [*]
(3) If the Parties, after good faith discussions, are unable to
reasonably determine that particular post-FDA Product approval
modifications to the Process agreed upon hereunder will benefit
both Buyer and BIP, Buyer will (unless otherwise agreed upon by
BIP) reimburse BIP for the reasonable and necessary expenses
incurred by BIP which are directly related to enabling BIP to
manufacture Bulk Drug Substance, Drug Product and Finished
Product in accordance with any such particular post-FDA Product
approval modifications to the Process.
89
ARTICLE 7. PACKAGING
7.1 IN GENERAL.
BIP shall package and label the Drug Product according to the Drug Product
Specifications and according to packaging procedures mutually agreed upon
by Buyer and BIP. To the extent Finished Product is the subject of Firm
Orders hereunder, BIP shall package and label the Finished Product
according to the Finished Product Specifications and according to packaging
procedures mutually agreed upon by Buyer and BIP.
7.2 ARTWORK FOR FINISHED PRODUCT.
Within a reasonable time prior to the first Delivery Date of Finished
Product hereunder, and at least [*] ([*]) days prior to any subsequent
modification to the artwork for Finished Product, Buyer shall in a timely
manner provide at no cost to BIP, the digital artwork for all packaging
components to be used in the manufacture of Finished Product for the
Immunex Territory and the Wyeth Territory, which artwork shall meet the
Finished Product Specifications. Notwithstanding the foregoing, BIP shall
use its reasonable efforts to accommodate modifications to such artwork in
a shorter time period.
ARTICLE 8. CLAIMS
8.1 CLAIMS.
(a) NOTICE OF CLAIMS. In the event that any Bulk Drug Substance, Drug
Product or Finished Product delivered hereunder shall fail to conform
with any warranty or any of the Specifications applicable thereto,
Buyer may reject the same after production or after shipment by giving
written notice thereof to BIP 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 carried specified by Buyer in Biberach, Germany), which
notice shall specify the manner in which such Bulk Drug Substance,
Drug Product or Finished Product, as the case may be, fails to conform
to any warranty or Specification applicable thereto. Alternatively,
rather than initially issuing a notice of rejection, Buyer may give
written notice to BIP within the time period set forth in this Section
8.1(a) of a Buyer decision to investigate whether a potentially
nonconforming shipment should be rejected, which investigation shall,
unless otherwise agreed upon by Buyer and BIP, be completed within the
time period set forth in this Section 8.1(a).
(b) NO BIP LIABILITY. If it is determined by agreement of the Parties (or
in the absence of such agreement, by a mutually acceptable qualified
Third Party whose fees shall be paid by the non-prevailing Party) that
the nonconformity is due to damage to such Bulk Drug Substance, Drug
Product or Finished Product caused by the Party receiving such
shipment or its agents subsequent to delivery of such Bulk Drug
Substance, Drug Product or Finished Product by BIP to the designated
carried specified by Buyer in Biberach, Germany, BIP shall have no
liability to such Party with respect thereto.
(c) BIP LIABILITY; REPLACEMENT OF PRODUCT. If it is determined by
agreement of the Parties (or in the absence of such agreement, by a
mutually acceptable qualified Third Party whose fees shall be paid by
the non-prevailing Party) that the nonconformity is caused by BIP, BIP
shall as soon as reasonably possible if available from either safety
stock (see Section 4.2(e) hereof) or from an existing production
campaign, but if not so available, then in no event later than [*]
([*]) days with respect to Bulk Drug Substance and [*] ([*]) days with
respect to Drug Product or Finished Product (and within the maximum
available capacity of the Biberach Facility), replace such
nonconforming Bulk Drug Substance, Drug Product or Finished Product,
as the case may be, with conforming Bulk Drug Substance, Drug Product
or Finished Product, as the case may be, at no additional cost to
Immunex and Wyeth.
90
(d) DISPOSITION OF NONCONFORMING PRODUCT. In any case where Immunex or
Wyeth expects to make a claim against BIP with respect to damaged or
otherwise nonconforming Bulk Drug Substance, Drug Product or Finished
Product, Immunex and Wyeth shall not dispose of or allow to be
disposed such Bulk Drug Substance, Drug Product or Finished Product,
as the case may be, without written authorization and instructions of
BIP either to dispose of or return to BIP such Bulk Drug Substance,
Drug Product or Finished Product. Upon written request by Buyer, BIP
agrees promptly to give the requesting Party such authorization and
instructions within a reasonable period of time.
ARTICLE 9. MANUFACTURING AUDITS, CERTIFICATE OF COMPLIANCE; REGULATORY MATTERS
9.1 MANUFACTURING AUDITS.
(a) ANNUAL AUDIT. BIP shall permit Immunex and Wyeth to conduct an "ANNUAL
AUDIT" once each Calendar Year during the Supply Term upon at least
[*] ([*]) days' prior notice to BIP and during BIP's normal business
hours, (1) to review the originals of all batch records and other
primary documents at BIP's facilities relating to the Product and in
connection with BIP's manufacturing activities hereunder and (2) to
conduct manufacturing audits at the Biberach Facility. To the extent
practicable, any such Annual Audit shall be conducted jointly by
Immunex and Wyeth personnel.
(b) EVENT AUDIT.
(1) In addition to the Annual Audit referred to in Section 9.1(a)
above, BIP shall permit Immunex and Wyeth to conduct an Event
Audit (as defined below) from time to time during the Supply Term
upon such reasonable prior notice to BIP as is appropriate under
the circumstances and during BIP's normal business hours, (i) to
review the originals of all batch records and other primary
documents at BIP's facilities relating to the Product and in
connection with BIP's manufacturing activities hereunder and (ii)
to conduct manufacturing audits at the Biberach Facility.
(2) An "EVENT AUDIT" shall be permitted in any of the following
circumstances:
(i) BIP shall have received a "WARNING LETTER" from the FDA or
EMEA relating to the manufacture, packaging or labeling of
the Product by BIP;
(ii) Buyer has rejected a shipment of Bulk Drug Substance, Drug
Product or Finished Product for a failure to meet any
warranty or Specifications relating thereto;
(iii) Immunex or Wyeth shall have received a series of complaints
(I.E., [*]) from Third Parties within any Calendar Year
relating to the manufacturing, packaging or labeling process
of such Drug Product or Finished Product; or
(iv) in the event of unusual data trends with respect to the
manufacturing, testing, packaging or labeling of Bulk Drug
Substance, Drug Product or Finished Product by BIP,
including, but not limited to, a series of lot failures or
stability failures.
(c) TERMS GENERALLY APPLICABLE TO AUDITS. To the extent practicable,
any Annual Audit or Event Audit shall be conducted jointly by
Immunex and Wyeth personnel and by a reasonable number of such
personnel. During any Annual Audit or Event Audit, as the case
may be, and upon Immunex's or Wyeth's request, BIP shall make
available for Immunex's and Wyeth's review BIP's batch records
for Bulk Drug Substance, Drug Product and/or Finished Product,
other raw materials and packaging components used in the
manufacture or packaging of Bulk Drug Substance, Drug Product
and/or Finished Product hereunder, and quality assurance and
quality control documents, procedures and test results for Bulk
Drug Substance, Drug Product and/or Finished Product, and any
documents required under cGMPs or applicable regulatory
guidelines. BIP shall use its reasonable efforts to facilitate
any such Annual Audits and Event Audits. BIP
91
shall provide written responses to the auditing Party within [*]
([*]) days after BIP's receipt of any audit observations
delivered by the auditing Party. While at any BIP facility,
Immunex and Wyeth personnel shall comply with all applicable BIP
security and safety policies and procedures.
9.2 CERTIFICATE OF ANALYSIS AND CERTIFICATE OF COMPLIANCE; MANUFACTURING
ISSUES; RELEASE ACTIVITIES; RECORDS.
(a) CERTIFICATE OF ANALYSIS AND CERTIFICATE OF COMPLIANCE; MANUFACTURING
ISSUES; RELEASE ACTIVITIES. BIP shall furnish the following to
Immunex, Wyeth and/or their respective designee on or before the date
of each shipment or invoice with respect to Bulk Drug Substance, Drug
Product and/or Finished Product hereunder: (1) a Certificate of
Analysis; (2) a Certificate of Compliance; and (3) [*]. In addition,
for each Batch of Bulk Drug Substance, Drug Product and/or Finished
Product manufactured hereunder, Buyer and BIP shall each perform their
respective release activities as are set forth in standard operating
procedures agreed upon by Buyer and BIP from time to time. BIP shall
also furnish to Buyer any testing samples of Bulk Drug Substance, Drug
Product and/or Finished Product that may be reasonably requested by
Buyer for assay and testing purposes.
(b) RECORDS. BIP shall maintain all of its manufacturing and analytical
records, all records of shipments of Bulk Drug Substance, Drug Product
and/or Finished Product hereunder, and all validation data relating to
Bulk Drug Substance, Drug Product and/or Finished Product for the time
periods required by applicable laws and regulations of the FDA and
EMEA. BIP agrees that, in response to any complaint or in the defense
by Immunex and/or Wyeth (as applicable) of any litigation, hearing,
regulatory proceeding or investigation relating to Bulk Drug
Substance, Drug Product and/or Finished Product, BIP shall use
reasonable efforts to make available to Immunex and/or Wyeth (as
applicable) during normal business hours and upon reasonable prior
written notice, such BIP employees and records reasonably necessary to
permit the effective response to, defense of, or investigation of such
matters, subject to appropriate confidentiality protections. Immunex
and/or Wyeth (as applicable) shall reimburse BIP for all reasonable
out-of-pocket costs and expenses incurred by BIP in connection with
the performance of BIP's obligations under the preceding sentence.
9.3 COMPLAINTS.
(a) IMMUNEX TERRITORY. Immunex shall maintain complaint files in accordance
with cGMP for the Immunex Territory. BIP shall provide Immunex and Wyeth
with a copy of any complaints received by BIP from the Immunex Territory
with respect to the Product within [*] ([*]) hours of receipt of notice
thereof. Immunex shall promptly provide BIP and Wyeth with a copy of any
complaints received by Immunex from the Immunex Territory relating to the
manufacture of the Product. Immunex or its designee shall have
responsibility for responding to all complaints from the Immunex Territory,
and for promptly providing BIP and Wyeth with a copy of any responses to
complaints, relating to the manufacture of the Product. Immunex or its
designee shall have responsibility for reporting any complaints relating to
the Product from the Immunex Territory to the FDA and any other regulatory
authority in the Immunex Territory, including, but not limited to,
complaints relating to the manufacture of the Product, as well as adverse
drug experience reports. BIP shall provide a response to Immunex, with a
copy to Wyeth, within [*] ([*]) days of a written request therefor with
respect to any complaint by a Third Party in the Immunex Territory
regarding the manufacturing, packaging or storage of the Product by BIP.
(b) WYETH TERRITORY. Wyeth shall maintain complaint files in accordance with
cGMP for the Wyeth Territory. BIP shall provide Wyeth and Immunex with a
copy of any complaints received by BIP from the Wyeth Territory with
respect to the Product within [*] ([*]) hours of receipt of notice thereof.
Wyeth shall promptly provide BIP and Immunex with a copy of any complaints
received by Wyeth from the Wyeth Territory relating to the manufacture of
the Product. Wyeth or its designee shall have responsibility for responding
to all complaints from the Wyeth Territory, and for promptly providing BIP
and Immunex with a copy of any responses to complaints, relating to the
manufacture of the Product. Wyeth or its designee shall have responsibility
for reporting any complaints relating to the Product from the Wyeth
Territory to the EMEA and any other regulatory authority in the Wyeth
Territory, including, but not limited to, complaints relating to the
manufacture of the Product, as well
92
as adverse drug experience reports. BIP shall provide a response to Wyeth,
with a copy to Immunex, within [*] ([*]) days of a written request therefor
with respect to any complaint by a Third Party in the Wyeth Territory
regarding the manufacturing, packaging or storage of the Product by BIP.
9.4 REGULATORY CORRESPONDENCE.
(a) NOTIFICATION TO OTHER PARTIES OF REGULATORY CORRESPONDENCE. Each Party
shall promptly (and in any event, within [*] days of the date of
receipt of notice) notify the other Parties in writing of, and shall
provide the other Parties with copies of, any correspondence and other
documentation received or prepared by such Party in connection with
any of the following events: (1) receipt of a regulatory letter,
Warning Letter, or similar item, from the FDA, EMEA or any other
regulatory authority directed to the manufacture, packaging, and
storage of Bulk Drug Substance, Drug Product and/or Finished Product,
or in connection with any general cGMP inspections applicable to any
BIP facility associated with BIP's activities hereunder; (2) any
recall, market withdrawal or correction of any Batch of Bulk Drug
Substance, Drug Product and/or Finished Product from any market in the
Immunex Territory or Wyeth Territory; and (3) any regulatory comments
relating to the manufacture of Bulk Drug Substance, Drug Product
and/or Finished Product requiring a response or action by a Party.
(b) REGULATORY CORRESPONDENCE REQUIRING A BIP RESPONSE. In the event BIP
receives any regulatory letter or comments from any federal, state or
local regulatory authority directed to its manufacture of Bulk Drug
Substance, Drug Product and/or Finished Product requiring a response
or action by BIP, including, but not limited to, receipt of a Form 483
(Inspectional Observations) or a Warning Letter, Immunex and/or Wyeth
(as applicable) promptly will provide BIP with any data or information
required by BIP in preparing any response relating to BIP's
manufacture of Bulk Drug Substance, Drug Product and/or Finished
Product, and will cooperate fully with BIP in preparing such response.
BIP shall provide Immunex and Wyeth with a copy of each such response
for Immunex's and Wyeth's review and comment prior to BIP's submission
of the response. BIP shall give all due consideration to any Immunex
and Wyeth comments to each such proposed BIP response.
9.5 INSPECTIONS; NON-COMPLIANCE; FAILURE TO MANUFACTURE.
(a) INSPECTIONS. In the event the Biberach Facility will be inspected by
representatives of any federal, state or local regulatory agency
directed to BIP's manufacture of Bulk Drug Substance, Drug Product
and/or Finished Product, BIP shall notify Immunex and Wyeth within [*]
([*]) hours upon learning of such inspection, and shall supply Immunex
and Wyeth with copies of any correspondence or portions of
correspondence which relate to Bulk Drug Substance, Drug Product
and/or Finished Product. [*]
(b) NON-COMPLIANCE; FAILURE TO MANUFACTURE. In the event that any
regulatory agency shall determine, as a result of an inspection
described in Section 9.5(a) above, that BIP is not in compliance with
applicable laws or regulations, BIP shall at its expense (but subject
to Section 6.3(b) hereof) use all reasonable efforts to cure such
non-compliance as soon as practicable if such determination was made
by the FDA or the EMEA. Any potential BIP curative efforts referred to
in the immediately preceding sentence related to any such
determinations by regulatory agencies other than the FDA or the EMEA
shall be mutually agreed upon by the Parties. In the event BIP
receives a Warning Letter from the FDA or EMEA and as a result BIP is
unable to manufacture Bulk Drug Substance, Drug Product and/or
Finished Product for a particular period, then the provisions of
Section 20.4 and Section 20.5 hereof shall apply, MUTATIS MUTANDIS,
it being understood that BIP's inability to manufacture Bulk Drug
Substance, Drug Product and/or Finished Product for the reasons set
forth in this Section 9.5 shall not automatically be deemed a Force
Majeure Event if BIP's inability to manufacture was caused by BIP's
gross negligence or willful misconduct.
9.6 REGULATORY CONTACTS.
Each Party shall notify the other Parties in a timely manner of any
meetings or substantive discussions with the FDA, EMEA or any other
regulatory authority that directly relate to the manufacture, supply and/or
quality control of the Product manufactured by BIP hereunder, and the other
Parties shall have the right but not the obligation to have at least one
representative participate in such meetings or discussions referred to
above.
93
ARTICLE 10. RECALLS
10.1 RECALLS.
(a) IMMUNEX TERRITORY. Each Party shall notify the other Parties promptly
(and in any event within [*] days of receipt of written notice) if any
Batch of Bulk Drug Substance, Drug Product or Finished Product is
alleged or proven to be the subject of a recall, market withdrawal or
correction in any country in the Immunex Territory. Immunex and BIP
shall cooperate in the handling and disposition of such recall, market
withdrawal or correction in the Immunex Territory; provided, however,
in the event of a 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 and in good faith. Immunex
shall bear the cost of all recalls, market withdrawals or corrections
of Bulk Drug Substance, Drug Product or Finished Product in the
Immunex Territory unless such recall, market withdrawal or correction
shall have been the result of BIP's breach of any of its warranties
set forth in Section 6.1 hereof or shall have been the result of BIP's
grossly negligent breach of any of its obligations hereunder, in which
case BIP 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 the Product in the Immunex Territory.
(b) WYETH TERRITORY. Each Party shall notify the other Parties promptly
(and in any event within [*] days of receipt of written notice) if any
Batch of Bulk Drug Substance, Drug Product or Finished Product is
alleged or proven to be the subject of a recall, market withdrawal or
correction in any country in the Wyeth Territory. Wyeth and BIP shall
cooperate in the handling and disposition of such recall, market
withdrawal or correction in the Wyeth Territory; provided, however, in
the event of a 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 and in good faith. Wyeth shall
bear the cost of all recalls, market withdrawals or corrections of
Bulk Drug Substance, Drug Product or Finished Product in the Wyeth
Territory unless such recall, market withdrawal or correction shall
have been the result of BIP's breach of any of its warranties set
forth in Section 6.1 hereof or shall have been the result of BIP's
grossly negligent breach of any of its obligations hereunder, in which
case BIP 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 the Product in the Wyeth Territory.
(c) [*]
ARTICLE 11. QUALITY ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY
11.1 RESPONSIBILITY FOR QUALITY ASSURANCE AND QUALITY CONTROL.
Responsibility for quality assurance and quality control of Bulk Drug
Substance, Drug Product and Finished Product shall be allocated between
Buyer and BIP as set forth in standard operating procedures agreed upon by
Buyer and BIP from time to time. In general, (a) BIP shall be responsible
for performing a manufacturer's lot release on all Bulk Drug Substance,
Drug Product and Finished Product and (b) Buyer shall be responsible for
performing final release of all Bulk Drug Substance, Drug Product and
Finished Product.
94
11.2 VALIDATION OF BIBERACH FACILITY, UTILITIES AND EQUIPMENT. BIP
shall maintain cGMP validation status on the Biberach Facility, as well as
the utilities and equipment used in the manufacture of Bulk Drug Substance,
Drug Product and Finished Product, and shall make validation reports
applicable thereto available to Buyer for onsite review.
11.3 VALIDATION OF PRODUCT MANUFACTURING PROCESS.
BIP shall maintain cGMP validation status of process procedures with
respect to the manufacturing, filling, packaging, shipping and cleaning
procedures that are used in the manufacture of Bulk Drug Substance, Drug
Product and Finished Product, and shall provide copies of validation
reports applicable thereto to Buyer on a frequency and in a format to be
agreed upon by BIP and Buyer.
11.4 CHANGE CONTROL.
Any changes to the Biberach Facility, utilities, equipment or processes
used in the manufacturing, filling, packaging, shipping and cleaning with
respect to the manufacture of Bulk Drug Substance, Drug Product and
Finished Product shall occur pursuant to change control procedures agreed
upon by BIP and Buyer. Such change control procedures shall require BIP to
obtain approval of the Buyer prior to the implementation of any change on
Product specific documents having an impact on the respective
Specifications for Bulk Drug Substance, Drug Product and Finished Product.
BIP shall have responsibility for validating any such changes to cGMP
standards.
11.5 STABILITY.
(a) STABILITY TESTING. BIP shall conduct all necessary stability testing
with Bulk Drug Substance Lots to comply with cGMP. Buyer shall inform
BIP from time to time of any additional stability testing to be done
by BIP in order to comply with any other applicable regulatory
guidelines. All such stability testing shall be conducted in
accordance with stability protocols agreed upon by Buyer. Such
stability testing shall include annual stability lots, supportive data
for process changes and deviations or reprocessing of Bulk Drug
Substance, Drug Product and Finished Product. Such stability testing
shall also include testing as agreed upon by the Parties to validate
the lead times for shipment, the shelf life of Bulk Drug Substance,
Drug Product and Finished Product, and the Specifications applicable
to shipment, storage and handling of Bulk Drug Substance, Drug Product
and Finished Product.
(b) TRENDING OF STABILITY DATA. BIP shall also perform routine trending of
stability data and shall provide such data to Buyer at intervals to be
agreed upon by the Parties. Buyer shall approve all stability
dispositions and changes to stability protocols or stability
specifications as defined in the appropriate standard operating
procedure.
ARTICLE 12. BIP'S OBLIGATIONS AS MANUFACTURER
12.1 CONTROL OF MASTER CELL BANK AND WORKING CELL BANK.
BIP shall maintain a portion of the Master Cell Bank and Working Cell Bank
in safe and secure storage under its control in its facilities and shall
not permit the transfer of the Master Cell Bank or Working Cell Bank to any
Third Party that is not specifically authorized by Immunex and Wyeth. BIP
shall comply with all applicable FDA and EMEA regulatory requirements
relating to general safety and biosafety in handling the Master Cell Bank
and Working Cell Bank and any raw materials used in manufacturing Bulk Drug
Substance, Drug Product and Finished Product hereunder.
12.2 MANUFACTURING CAPABILITIES.
BIP shall at all relevant times throughout the Supply Term (a) own or
lawfully control all the necessary plant, equipment and facilities and (b)
have sufficient numbers of appropriately qualified personnel, in each case
to enable BIP to manufacture Bulk Drug Substance, Drug Product and Finished
Product in accordance with the Specifications and in quantities sufficient
to fulfill the Firm Orders made within the Maximum Request under this
Agreement.
95
12.3 COMPLIANCE WITH LAW.
BIP shall perform all work hereunder, including, but not limited to,
manufacturing, labeling, packaging and shipping all Bulk Drug Substance,
Drug Product and Finished Product, in conformance with cGMP and in
conformance with all applicable national, state and local laws, ordinances
and governmental rules or regulations of Germany and the EMEA.
12.4 BIBERACH FACILITY.
BIP undertakes that the Biberach Facility where BIP will manufacture Bulk
Drug Substance, Drug Product and Finished Product, and all the procedures
used in manufacturing and processing, shall be in accordance with cGMP and
shall enable BIP to maintain manufacturing of Bulk Drug Substance, Drug
Product and Finished Product according to the applicable Specifications.
12.5 STORAGE FACILITIES.
BIP shall provide sufficient and suitable storage facilities that meet the
Specifications for Bulk Drug Substance, Drug Product and Finished Product
for all quantities of Bulk Drug Substance, Drug Product and Finished
Product ordered according to the provisions of this Agreement.
12.6 REGULATORY DOCUMENTATION.
(a) IMMUNEX TERRITORY.
(1) BIP shall provide Immunex in a timely manner with a copy of any
BIP manufacturing and control records for Bulk Drug Substance,
Drug Product and Finished Product which are required for any
Immunex regulatory filings with respect to the Product in the
Immunex Territory, which records shall be in BIP's standard
formats unless otherwise agreed upon by Immunex and BIP.
(2) BIP shall provide Immunex with all documents reasonably requested
by Immunex relating to the FDA's and EMEA's pre-approval
inspection of the Biberach Facility, including, but not limited
to, development reports, chemistry, manufacturing and controls
("CMC") sections of Immunex's BLA for the Product, as well as
available stability data. In addition, BIP and Wyeth shall each
provide Immunex within [*] ([*]) days after the end of each
annual reporting period for the Product (as calculated consistent
with appropriate regulations and guidelines) with such
information as is reasonably requested in writing by Immunex for
the preparation of the annual report with respect to the
manufacturing and control of the Product for such annual
reporting period. Thereafter, Immunex shall provide to BIP and
Wyeth at least [*] ([*]) days prior to Immunex's filing with the
respective regulatory authorities a copy of such Immunex annual
report, and Immunex shall take into consideration any BIP and
Wyeth comments to such annual report with respect to the Product.
(b) WYETH TERRITORY.
(1) BIP shall provide Wyeth in a timely manner with a copy of any BIP
manufacturing and control records for Bulk Drug Substance, Drug
Product and Finished Product which are required for any Wyeth
regulatory filings with respect to the Product in the Wyeth
Territory, which records shall be in BIP's standard formats
unless otherwise agreed upon by Wyeth and BIP.
(2) BIP shall provide Wyeth with all documents reasonably requested
by Wyeth relating to the FDA's and EMEA's pre-approval inspection
of the Biberach Facility, including, but not limited to,
development reports, CMC sections of Wyeth's EMEA-dossier for the
Product, as well as available stability data. In addition, BIP
and Immunex shall each provide Wyeth within [*] ([*]) days after
the end of each annual reporting period for the Product (as
calculated consistent with appropriate regulations and
guidelines) with such information as is reasonably requested in
writing by Wyeth for the preparation of the annual report with
respect to the manufacturing and control of the Product for such
annual reporting period. Thereafter, Wyeth shall provide to BIP
and Immunex at least [*] ([*]) days prior to Wyeth's filing with
the respective regulatory authorities a copy of such Wyeth annual
report, and
96
Wyeth shall take into consideration any BIP and Immunex comments
to such annual report with respect to the Product.
(c) REGULATORY FILING GROUP.
The Parties shall establish a working group consisting of one or more
representatives of each Party (the "REGULATORY FILING GROUP") to
coordinate the activities of and the flow of information among the
Parties in support of regulatory filings with respect to the Product
in the Territory. The Regulatory Filing Group shall not have decision
making authority, but shall promote cooperation and assistance
necessary to support regulatory filings with respect to the Product.
Meeting schedules and methods of communication shall be informally
established by the Regulatory Filing Group. Each Party may change its
representative(s) in the Regulatory Filing Group at any time for any
reason.
12.7 MATERIALS AND INFORMATION TO BE DELIVERED BY BIP.
(a) [*]
(b) [*]
(c) MANUFACTURING DATA. To assist Buyer in its forecasting and ordering of
Bulk Drug Substance, Drug Product and Finished Product hereunder, BIP
shall collect data on the yield from each Bulk Drug Substance Lot, as
well as the date of manufacture of each such Bulk Drug Substance Lot
and each Batch of Drug Product and Finished Product. BIP shall furnish
such data to Buyer on a regular basis throughout the Supply Term in
the form of a monthly manufacturing status report in BIP's standard
format unless otherwise agreed upon by Buyer and BIP.
(d) [*]
(e) OTHER INFORMATION. BIP shall provide such other information and
materials as are agreed upon by the Parties from time to time.
12.8 RETENTION AND RESERVE SAMPLES. BIP shall isolate, identify and, subject to
Section 19.3(e)(3) hereof, retain retention and reserve samples of all raw
materials and in-process production steps used in the production of Bulk
Drug Substance, Drug Product and Finished Product for such period as agreed
upon by the Parties. BIP shall retain quantities of such retention and
reserve samples at least equal to [*] ([*]) times the amounts required to
perform full testing of such retention and reserve samples. All retention
and reserve samples shall be promptly provided by BIP to Buyer at Buyer's
request, provided that BIP may retain one set of such samples for
documentation purposes. Shipment of such samples shall be at Buyer's cost
and risk.
12.9 ANALYTICAL TESTING. BIP shall not perform any analytical testing on Bulk
Drug Substance, Drug Product or Finished Product unless agreed to by Buyer.
In addition, any decision hereunder to implement any new analytical methods
or testing with respect to Bulk Drug Substance, Drug Product or Finished
Product shall in each case be a joint decision of Buyer and BIP.
12.10 THIRD PARTY VENDORS. The Parties acknowledge that effectively managing and
coordinating the Third Party Vendors (as defined in Section 6.3(c) hereof)
is extremely important and in each of the Parties' best interests. [*]
12.11 DOCUMENTATION. Any records and documentation provided to Immunex and/or
Wyeth hereunder in connection with BIP's manufacture of Bulk Drug
Substance, Drug Product or the Finished Product shall be accurate in all
material respects.
12.12 YEAR 2000. BIP is currently working to ensure that the functionality and
performance of the Biberach Facility and the computer systems and computer
programs which affect or may affect the manufacturing or testing of Bulk
Drug Substance, Drug Product and/or Finished Product hereunder will not be
affected
97
by dates prior to, during and after the year 2000. BIP shall use all
commercially reasonable efforts to ensure that it will be able to fulfill
the Firm Orders made within the Maximum Request under this Agreement prior
to, during and after the year 2000.
ARTICLE 13. LICENSE GRANTS
13.1 LICENSE TO USE OF CELL LINE AND INTELLECTUAL PROPERTY. Immunex and Wyeth
hereby grant to BIP a limited right and license to use the Cell Line,
Process and Immunex/Wyeth Confidential Information solely for the purpose
of manufacturing and delivering Bulk Drug Substance, Drug Product and
Finished Product hereunder.
13.2 LICENSE TO BIP CONFIDENTIAL INFORMATION. In consideration of the
development fees previously paid to BIP by Immunex and Wyeth under the
Phase I Agreement and Phase II Agreement, and in consideration of amounts
paid hereunder, BIP hereby grants to Immunex and Wyeth a worldwide,
royalty-free, perpetual, license to use BIP Confidential Information that
is or may during the Supply Term be used in carrying out the Process to
test, develop, register, make, have made, use, market, distribute, import,
offer for sale and sell the Product. Such license to Immunex and Wyeth
shall be (1) exclusive as to BIP and all Third Parties for any Product
specific BIP Confidential Information, subject only to BIP's retained
rights under this Agreement to develop and manufacture Product solely on
behalf of Immunex and Wyeth, and (2) non-exclusive for any non-Product
specific BIP Confidential Information. With respect to the Product, Immunex
and Wyeth's license rights to make and have made as set forth in this
Section 13.2 shall be applicable in the circumstances set forth in Sections
3.2 and 3.3 hereof, and shall also be applicable after the Supply Term.
ARTICLE 14. USE OF DATA; OWNERSHIP OF INTELLECTUAL PROPERTY; [*]; FUTURE
ACTIVITIES
14.1 USE OF MANUFACTURING DATA. In consideration of the amounts paid hereunder,
BIP shall carry out its obligations hereunder and BIP shall transfer and/or
otherwise make available to Immunex and Wyeth in accordance with the terms
hereof all relevant information obtained and reasonably requested by Buyer
in the course of manufacturing the Bulk Drug Substance, Drug Product and
Finished Product. However, this shall not apply to information regarding
BIP's facility and technical equipment. Immunex and Wyeth shall have the
right to use all such transferred information, with the exception of BIP
Confidential Information, for any purpose without further obligation to
BIP.
14.2 OWNERSHIP OF INTELLECTUAL PROPERTY. Immunex and Wyeth shall jointly own the
Cell Line, Master Cell Bank, Working Cell Bank, and the Product, as well as
any and all improvements or enhancements made to the Cell Line, Master Cell
Bank, Working Cell Bank and/or the Product while in BIP's possession or
control. Immunex and Wyeth shall also jointly own all Immunex/Wyeth
Confidential Information. BIP shall own all BIP Confidential Information,
provided, however, that notwithstanding anything herein to the contrary,
and irrespective of whether any BIP Confidential Information is utilized
with respect to any improvements or enhancements made to the Cell Line,
Master Cell Bank, Working Cell Bank and/or the Product, Immunex and Wyeth
shall be the sole and exclusive owners of the Cell Line, Master Cell Bank,
Working Cell Bank and the Product.
14.3 [*]
14.4 FUTURE ACTIVITIES.
(a) [*]
(b) NON-ASSERTION. Immunex and Wyeth shall not assert any right to use the
Biberach Facility at any future date as a result of its use of the
Biberach Facility pursuant to this Agreement, except as expressly
provided for herein.
98
ARTICLE 15. REPRESENTATIONS AND WARRANTIES
15.1 IMMUNEX AND WYETH.
Immunex and Wyeth hereby represent and warrant to BIP that:
(a) Immunex and Wyeth are free to supply the Cell Line and Immunex/Wyeth
Confidential Information to BIP;
(b) Immunex and Wyeth are not aware of any special or unusual hazards
involved in handling the Cell Line or the Product;
(c) Immunex and Wyeth have the corporate power and authority and the legal
right to enter into this Agreement and to perform their respective
obligations hereunder; and
(d) Immunex and Wyeth have taken all necessary corporate action on their
part to authorize the execution and delivery of this Agreement and the
performance of their respective obligations hereunder. This Agreement
has been duly executed and delivered on behalf of Immunex and Wyeth,
and constitutes a legal, valid, binding obligation, enforceable
against Immunex and Wyeth in accordance with its terms.
15.2 BIP.
BIP hereby represents and warrants to Immunex and Wyeth that:
(a) BIP is the owner of the BIP Confidential Information;
(b) BIP owns or lawfully controls the Biberach Facility, and has a
sufficient number of employees with such expertise and experience as
is necessary or appropriate to produce Bulk Drug Substance, Drug
Product and Finished Product in accordance with the terms hereof and
in quantities sufficient to fulfill the Firm Orders made within the
Maximum Request under this Agreement;
(c) BIP is not aware of any special or unusual hazards that would arise as
a result of its carrying out of its obligations hereunder;
(d) BIP has the corporate power and authority and the legal right to enter
into this Agreement and to perform its obligations hereunder; and
(e) BIP 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 BIP, and constitutes a legal, valid, binding
obligation, enforceable against BIP in accordance with its terms.
ARTICLE 16. INDEMNIFICATION
16.1 INDEMNIFICATION BY IMMUNEX AND WYETH.
(a) INDEMNIFICATION BY IMMUNEX. Subject to the extent of any
indemnification from BIP pursuant to Section 16.2 below, Immunex shall
indemnify, defend and hold BIP, its Affiliates, 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 (1) 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 or Finished Product in the Immunex
Territory, (2) any material breach of the representations, warranties
and covenants made by Immunex hereunder, or (3) Immunex's grossly
negligent acts or omissions or willful misconduct.
99
(b) INDEMNIFICATION BY WYETH. Subject to the extent of any indemnification
from BIP pursuant to Section 16.2 below, Wyeth shall indemnify, defend
and hold BIP, its Affiliates, and their respective directors,
officers, employees and agents harmless from and against all
Liabilities to the extent such Liabilities arise out of or result from
(1) 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 or Finished Product in the Wyeth
Territory, (2) any material breach of the representations, warranties
and covenants made by Wyeth hereunder, or (3) Wyeth's grossly
negligent acts or omissions or willful misconduct.
(c) ADDITIONAL INDEMNIFICATION BY IMMUNEX AND WYETH. Immunex and Wyeth
shall indemnify, defend and hold BIP, its Affiliates, and their
respective directors, officers, employees and agents harmless from and
against all Liabilities to the extent such Liabilities arise out of or
result from [*].
16.2 INDEMNIFICATION BY BIP.
Subject to the extent of any indemnification from Immunex and/or Wyeth
pursuant to Section 16.1(a), (b), and (c) above, BIP shall indemnify,
defend and hold Immunex, Wyeth and their respective Affiliates, directors,
officers, employees and agents harmless from and against all Liabilities to
the extent such Liabilities arise out of or result from (a) any material
breach of the representations, warranties and covenants made by BIP under
Sections [*] hereof or (b) BIP's grossly negligent acts or omissions or
willful misconduct in the manufacture or labeling of the Bulk Drug
Substance, Drug Product or Finished Product.
16.3 INDEMNIFICATION PROCEDURES.
(a) IDENTIFICATION OF INDEMNITOR AND INDEMNITEE. An "INDEMNITOR" means
Immunex with respect to Section 16.1(a) hereof, Wyeth with respect to
Section 16.1(b) hereof, Immunex and Wyeth with respect to Section
16.1(c) hereof, and BIP with respect to Section 16.2 hereof. An
"INDEMNITEE" means any of BIP, its Affiliates, and their respective
directors, officers, employees and agents with respect to Section
16.1(a), (b), and (c) hereof, and any of Immunex, Wyeth, and their
respective Affiliates, directors, officers, employees and agents with
respect to Section 16.2 hereof.
(b) INDEMNIFICATION PROCEDURES. An Indemnitee which intends to claim
indemnification under Section 16.1 or 16.2 hereof shall promptly
notify the Indemnitor in writing of any claim, lawsuit or other action
in respect of which the Indemnitee, its Affiliates, or any of their
respective directors, officers, employees and agents intend to claim
such indemnification. The Indemnitee shall permit, and shall cause its
Affiliates and their respective directors, officers, employees and
agents 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,
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 Affiliates and their respective
directors, officers, employees and agents 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.
16.4 SURVIVAL OF INDEMNIFICATION OBLIGATIONS.
The provisions of this Article 16 shall survive the termination or
expiration of this Agreement for a period of [*] ([*]) years.
16.5 DISCLAIMER OF CONSEQUENTIAL DAMAGES.
In no event shall any Party be liable to the other Parties for incidental,
special, or consequential damages, including, but not limited to, any
claims for damages based upon lost profits. The foregoing limitation on
damages shall not be applicable to damages which arise out of the willful
misconduct of a Party.
100
16.6 LIMITATION OF LIABILITY OF BIP.
BIP's total liability under this Agreement with respect to any Calendar
Year shall not exceed [*] percent ([*]%) of the aggregate Product Price for
any and all Firm Orders for Bulk Drug Substance, Drug Product and Finished
Product with respect to such Calendar Year. For each year within the period
set forth in Section 16.4 above, the relevant year for calculating BIP's
limitation of liability shall be the last full Calendar Year during the
Supply Term.
ARTICLE 17. CONFIDENTIALITY
17.1 CONFIDENTIALITY OBLIGATIONS.
(a) BIP CONFIDENTIALITY OBLIGATIONS. BIP shall not disclose Immunex/Wyeth
Confidential Information to any Third Party other than
(1) its employees or employees of affiliated companies of the
Boehringer Ingelheim group who have a need to know such
information in order to perform their duties in carrying out
BIP's obligations hereunder,
(2) contractors who are bound by similar obligations of
confidentiality and who have a need to know such information in
order to provide direction to BIP or Immunex and/or Wyeth, or
(3) regulatory authorities, for example, the FDA, that require such
information in order to review a BLA or other regulatory filing.
(b) IMMUNEX AND WYETH CONFIDENTIALITY OBLIGATIONS.
Immunex and Wyeth shall not disclose any BIP Confidential Information
to any Third Party other than
(1) their employees, consultants, Affiliates, agents or contractors
who are bound by similar obligations of confidentiality and who
have a need to know such information in order to provide
direction to Immunex and/or Wyeth or to BIP, or
(2) regulatory authorities, for example, the FDA, that require such
information in order to review a BLA or other regulatory filing.
17.2 TERMS OF AGREEMENT. Subject to Section 17.4 hereof, and except for any
disclosure as is deemed necessary, in the reasonable judgment of the
responsible Party, to comply with national, federal or state laws or
regulations with respect to regulatory reporting or disclosure obligations,
neither Party shall, without the prior written consent of the other Party,
disclose in any manner to any Third Party the terms and conditions of this
Agreement. For purposes of this Section 17.2, Immunex and Wyeth shall be
deemed the same Party.
17.3 EXCLUSIONS.
The obligations of confidentiality and nonuse applicable to Immunex/Wyeth
Confidential Information and BIP Confidential Information shall not apply
to any information which:
(a) at the time of disclosure, is known publicly or thereafter becomes
known publicly through no fault of the recipient, its Affiliates or
agents;
(b) becomes available to the recipient from a Third Party which is not
legally prohibited from disclosing such information, provided such
information was not acquired directly or indirectly from the
disclosing Party;
(c) was developed by the recipient independently of information obtained
from the disclosing Party;
(d) was already known to the recipient before receipt from the disclosing
Party, as shown by its prior written records; or
101
(e) is released with the prior written consent of the disclosing Party.
17.4 NOTIFICATION OF MANDATORY DISCLOSURE.
(a) NOTIFICATION AND CONSULTATION. In the event that any Party is required
by applicable statute or regulation or by judicial or administrative
process to disclose any part of another Party's Confidential
Information which is disclosed to it hereunder, the recipient shall
(1) promptly notify the disclosing Party of each such requirement and
identify the documents so required thereby, so that the disclosing
Party may seek an appropriate protective order or other remedy and/or
waive compliance by the recipient with the provisions of this
Agreement and (2) consult with the disclosing Party on the
advisability of taking legally available steps to resist or narrow the
scope of such requirement.
(b) LIMITED DISCLOSURE. If, in the absence of such a protective order or
such a waiver by the disclosing Party of the provisions of this
Agreement, the recipient is nonetheless required by mandatory
applicable law to disclose any part of the other Party's Confidential
Information which is disclosed to it hereunder, the recipient may
disclose such Confidential Information without liability under this
Agreement, except that the recipient shall furnish only that portion
of the Confidential Information which is legally required.
17.5 NO LICENSES; MAINTENANCE OF CONFIDENTIALITY; NONUSE OBLIGATIONS.
(a) NO LICENSES. Except as expressly provided in Article 13 hereof, no
right or license, either express or implied, under any patent or
proprietary right is granted hereunder by virtue of the disclosure to
BIP of Immunex/Wyeth Confidential Information, or the disclosure to
Immunex and/or Wyeth of BIP Confidential Information hereunder.
(b) MAINTENANCE OF CONFIDENTIALITY. Each Party shall use reasonable and
customary precautions to safeguard the other Parties' Confidential
Information, including ensuring that all employees, consultants,
agents or contractors who are provided access to such Confidential
Information are informed of the confidential and proprietary nature of
such Confidential Information and agree that all such Confidential
Information is required to be maintained confidential.
(c) NONUSE OBLIGATIONS. Immunex/Wyeth Confidential Information shall not
be utilized by BIP except for purposes of this Agreement, without
first obtaining Immunex's and Wyeth's prior written consent to such
utilization. BIP Confidential Information shall not be utilized by
Immunex or Wyeth except as set forth in this Agreement, without first
obtaining BIP's prior written consent to such utilization.
17.6 SURVIVAL OF CONFIDENTIALITY OBLIGATIONS.
The provisions of this Article 17 shall survive the termination or
expiration of this Agreement for a period of [*] ([*]) years.
ARTICLE 18. PRESS RELEASES; USE OF NAMES
18.1 PRESS RELEASES.
No press release, publicity or other form of public written disclosure
related to this Agreement shall be permitted by either Party to be
published or otherwise disclosed unless the other Party has indicated its
consent to the form of the release in writing, except for any disclosure as
is deemed necessary, in the reasonable judgment of the responsible Party,
to comply with national, federal or state laws or regulations with respect
to regulatory reporting or disclosure obligations. For purposes of this
Section 18.1, Immunex and Wyeth shall be deemed the same Party.
18.2 USE OF NAMES.
BIP shall not make use of the name of the other Parties in any advertising
or promotional material, or otherwise, without the prior written consent of
the other Parties.
102
ARTICLE 19. TERM; TERMINATION
19.1 TERM; RENEWAL.
Unless sooner terminated pursuant to the terms of this Agreement, the term
of this Agreement shall commence upon the Effective Date and shall continue
thereafter for not less than [*] ([*]) Contract Years from the Effective
Date (the "SUPPLY TERM"). This Agreement and the Supply Term shall
automatically continue from Contract Year-to-Contract Year thereafter
unless terminated by either Party by providing at least [*] prior written
notice to the other Party, provided that neither Party may provide such
notice prior to the end of the [*] Contract Year, and provided further that
BIP may not provide such notice prior to the end of the [*] Contract Year.
For purposes of this Section 19.1, Immunex and Wyeth shall be deemed the
same Party.
19.2 TERMINATION.
This Agreement may be terminated prior to the period set forth in Section
19.1 above as follows:
(a) MATERIAL BREACH.
(1) BIP MATERIAL BREACH. This Agreement may be terminated in its
entirety by Immunex and Wyeth upon written notice thereof to BIP
in the event of a material breach by BIP which is not cured
within [*] ([*]) days from written notice to BIP specifying in
reasonable detail the nature of such breach or longer if BIP
delivers a certificate that such material breach is not
reasonably capable of being cured within [*] ([*]) days and that
BIP is working diligently to cure such breach, but in no event
shall the time for curing such breach exceed an additional [*]
([*]) days.
(2) IMMUNEX MATERIAL BREACH. This Agreement may be terminated in its
entirety solely with respect to the Immunex Territory by BIP upon
written notice thereof to Immunex in the event of a material
breach by Immunex which is not cured within [*] ([*]) days from
written notice to Immunex specifying in reasonable detail the
nature of such breach or longer if Immunex delivers a certificate
that such material breach is not reasonably capable of being
cured within [*] ([*]) days and that Immunex is working
diligently to cure such breach, but in no event shall the time
for curing such breach exceed an additional [*] ([*]) days. In
such event, Wyeth and BIP shall thereafter enter into good faith
negotiations to amend this Agreement by making any necessary and
appropriate revisions as may be mutually agreed upon.
(3) WYETH MATERIAL BREACH. This Agreement may be terminated in its
entirety solely with respect to the Wyeth Territory by BIP upon
written notice thereof to Wyeth in the event of a material breach
by Wyeth which is not cured within [*] ([*]) days from written
notice to Wyeth specifying in reasonable detail the nature of
such breach or longer if Wyeth delivers a certificate that such
material breach is not reasonably capable of being cured within
[*] ([*]) days and that Wyeth is working diligently to cure such
breach, but in no event shall the time for curing such breach
exceed an additional [*] ([*]) days. In such event, Immunex and
BIP shall thereafter enter into good faith negotiations to amend
this Agreement by making any necessary and appropriate revisions
as may be mutually agreed upon.
(b) MUTUAL AGREEMENT. This Agreement may be terminated in its entirety at
any time upon mutual written agreement between all the Parties signed
by an executive officer of each Party.
(c) PRODUCT NOT COMMERCIALIZED.
(1) IMMUNEX TERRITORY. This Agreement may be terminated by Immunex
(after consultation with Wyeth) solely with respect to the
Immunex Territory upon at least [*] prior written notice to BIP
if (i) the BLA for the Product is not approved by the FDA by [*]
or (ii) the Product is not commercialized in the Immunex
Territory for any reason. In such event, Wyeth and BIP shall
thereafter enter into good faith negotiations to amend this
Agreement by making any necessary and appropriate revisions as
may be mutually agreed upon.
103
(2) WYETH TERRITORY. This Agreement may be terminated by Wyeth (after
consultation with Immunex) solely with respect to the Wyeth
Territory upon at least [*] prior written notice to BIP if (i)
the EMEA-dossier for the Product is not approved by the EMEA by
[*] or (ii) the Product is not commercialized in the Wyeth
Territory for any reason. In such event, Immunex and BIP shall
thereafter enter into good faith negotiations to amend this
Agreement by making any necessary and appropriate revisions as
may be mutually agreed upon.
(d) WITHDRAWAL OF PRODUCT.
(1) IMMUNEX TERRITORY. This Agreement may be terminated by Immunex
(after consultation with Wyeth) solely with respect to the
Immunex Territory upon at least [*] prior written notice to BIP
if the BLA for the Product is withdrawn by Immunex. In such
event, unless Wyeth has terminated the Agreement with respect to
the Wyeth Territory pursuant to Section 19.2(d)(2) below, Wyeth
and BIP shall thereafter enter into good faith negotiations to
amend this Agreement by making any necessary and appropriate
revisions as may be mutually agreed upon.
(2) WYETH TERRITORY. This Agreement may be terminated by Wyeth (after
consultation with Immunex) solely with respect to the Wyeth
Territory upon at least [*] prior written notice to BIP if the
EMEA-dossier for the Product is withdrawn by Wyeth or any of its
Affiliates. In such event, unless Immunex has terminated the
Agreement with respect to the Immunex Territory pursuant to
Section 19.2(d)(1) above, Immunex and BIP shall thereafter enter
into good faith negotiations to amend this Agreement by making
any necessary and appropriate revisions as may be mutually agreed
upon.
(e) FAILURE TO SUPPLY. This Agreement may be terminated in its entirety by
Immunex and Wyeth upon at least [*] prior written notice to BIP if in
any [*] consecutive months during the Supply Term, BIP shall have
delivered in at least [*] of those months less than [*] percent ([*]%)
of Drug Product and Finished Product it is required to deliver in
those months pursuant to Firm Orders delivered hereunder, unless such
failure to supply shall have been the result of a Force Majeure Event.
(f) BIBERACH FACILITY. This Agreement may be terminated in its entirety by
Immunex and Wyeth upon written notice thereof to BIP in the event that
BIP or its Affiliates cease to own or otherwise lawfully control the
Biberach Facility to the extent necessary to manufacture the Product
in accordance with the terms hereof in quantities sufficient to
fulfill the Firm Orders made within the Maximum Request under this
Agreement, provided that this Agreement may not be terminated under
this Section 19.2(f) if the conditions specified above are cured
within [*] from written notice to BIP specifying in reasonable detail
the nature of the breach giving rise to notice under this Section
19.2(f).
(g) FORCE MAJEURE. This Agreement may be terminated in its entirety by
Immunex and Wyeth upon at least [*] prior written notice under the
circumstances set forth in Section 20.4 hereof.
(h) [*]
19.3 CONSEQUENCES OF TERMINATION.
(a) PAYMENT OF AMOUNTS DUE; CUMULATIVE REMEDIES. Expiration or termination
of this Agreement for any reason shall not exempt any Party from
paying to any other Party any amounts due to such Party and
outstanding at the time of such expiration or termination. Except as
expressly stated otherwise herein, remedies hereunder are cumulative,
and nothing in this Agreement shall prevent any Party, in the case of
a breach, from not terminating this Agreement and seeking to enforce
its rights hereunder.
104
(b) PURCHASE OF BULK DRUG SUBSTANCE, DRUG PRODUCT AND FINISHED PRODUCT.
Upon expiration or termination of this Agreement, whichever is sooner
(but in the case of termination, only if directed by the terminating
Party in the notice of termination), BIP shall manufacture and ship,
and Immunex and/or Wyeth, as applicable, shall purchase in accordance
with the provisions hereof, any and all amounts of Bulk Drug
Substance, Drug Product and Finished Product ordered pursuant to Firm
Orders issued hereunder prior to the date on which notice of such
termination is given, or prior to the expiration date, as applicable.
(c) OTHER FINANCIAL OBLIGATIONS. Upon termination of this Agreement in its
entirety pursuant to Section 19.2(b) hereof, or upon termination of
this Agreement in whole or in part by Immunex and/or Wyeth pursuant to
Section 19.2(c), (d), or (h) hereof, and unless otherwise agreed upon
by the Parties in the event this Agreement is terminated with respect
to the Immunex Territory or the Wyeth Territory, but not both
territories, the following provisions shall apply:
(1) Immunex and/or Wyeth, as the case may be, shall purchase from BIP
at BIP's Acquisition Cost all raw materials, intermediates and
packaging components acquired by BIP specifically for the
manufacture and packaging of Product hereunder; provided,
however, the amount of raw materials, intermediates and packaging
components which Immunex and Wyeth are obligated to purchase
under this Section 19.3(c)(1) at any time shall not exceed the
amount of raw materials and packaging components reasonably
necessary to fulfill outstanding Firm Orders for Bulk Drug
Substance, Drug Product and Finished Product at such time, [*];
and
(2) Immunex and/or Wyeth, as the case may be, may purchase from BIP
all finished Bulk Drug Substance, Drug Product and Finished
Product then in BIP's possession or which BIP can manufacture in
a timely manner with then existing finished Bulk Drug Substance
(which had not been ordered pursuant to Firm Orders) at the then
current Product Price and in accordance with the provisions
hereof.
(d) PAYMENTS FOR PREMATURE TERMINATION. BIP shall be entitled to
reimbursement by Immunex and Wyeth for the following wind-down costs
in the event that this Agreement is terminated in its entirety
pursuant to Section 19.2(b) hereof or by Immunex and Wyeth pursuant to
Section 19.2(c), (d), or (h) hereof, it being understood that Immunex
and Wyeth's total liability under this Section 19.3(d) shall in no
event exceed the following amounts, calculated as follows:
(1) [*] after any termination of this Agreement referred to in this
Section 19.3(d), Immunex and Wyeth shall pay BIP the applicable
Product Price upon delivery according to the terms hereof of any
Firm Orders of Bulk Drug Substance, Drug Product and Finished
Product that are outstanding as of the effective date of such
termination, subject to an offset for any amounts paid to BIP
pursuant to Section 19.3(b) hereof, provided that for purposes of
this section, the Firm Order period for Bulk Drug Substance shall
be limited to [*];
(2) [*]
(3) [*]
(4) [*]
105
(5) For any of the [*] ([*]) years referred to in this Section
19.3(d), Immunex and Wyeth shall have the right to reduce or
eliminate the applicable termination payment for such year on a
proportional basis to the extent that Immunex, Wyeth and/or any
of their Affiliates are able to utilize BIP's production capacity
(such capacity being measured by the Annual Quantity as of the
effective date of termination, which is the base upon which
Immunex and Wyeth's termination payments are measured) with one
or more of their biological products of comparable volume per
product and technology, including but not limited to, in-licensed
biological products. The applicable technology transfer and
development costs, if any, and the supply price for such products
shall be negotiated in good faith on a case-by-case basis between
the Parties.
By way of example only, if BIP's manufacturing of such biological
products utilizes fifty percent (50%) of BIP's production
capacity (such capacity being measured by such Annual Quantity)
during a particular year, then the termination payment otherwise
owed by Immunex and Wyeth for such year would also be reduced by
fifty percent (50%).
(6) For any of the [*] ([*]) years referred to in this Section
19.3(d), BIP shall also provide a proportional reduction in the
applicable termination payment for such year owed by Immunex and
Wyeth to the extent that [*].
(d) FIRM ORDERS. Upon termination of this Agreement in its entirety by
Immunex and Wyeth pursuant to Section 19.2(a)(1), (e), (f) or (g)
hereof, Buyer may, in its discretion, cancel, in whole or in part, any
Firm Orders previously submitted.
(e) MASTER CELL BANK AND WORKING CELL BANK; RETURN OF IMMUNEX/WYETH
CONFIDENTIAL INFORMATION; RETURN OF RETENTION AND RESERVE SAMPLES.
Upon expiration or termination of this Agreement in its entirety,
unless otherwise directed by Buyer, BIP shall promptly (1) return or
at Buyer's election destroy the Master Cell Bank and Working Cell Bank
as well as the material derived from its culture, any such destruction
to be certified in writing to Immunex by an authorized BIP officer,
(2) return all Immunex/Wyeth Confidential Information to Buyer, except
for a single copy and/or sample for documentation purposes only, and
(3) return to Buyer all retention and reserve samples being held by
BIP pursuant to Section 12.8 hereof, provided that BIP may retain one
set of such samples for documentation purposes only.
(f) RETURN OF BIP CONFIDENTIAL INFORMATION. Upon expiration or termination
of this Agreement in its entirety, and at BIP's written request,
Immunex and Wyeth shall promptly return all BIP Confidential
Information to BIP that is unrelated to the Process, except for a
single copy and/or sample to be retained by Immunex and Wyeth for
documentation purposes only.
(g) ACCRUED RIGHTS, SURVIVING OBLIGATIONS. Except as set forth herein, any
termination or expiration of this Agreement shall be without prejudice
to any right which shall have accrued to the benefit of any Party and
shall not relieve any Party of any obligation which has accrued prior
to the effective date of such termination or expiration, which
obligations shall remain in full force and effect for the period
provided therein or, if no period is provided therein, then such
obligations shall remain in full force and effect indefinitely.
ARTICLE 20. FORCE MAJEURE
20.1 EFFECTS OF FORCE MAJEURE.
No Party 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.
106
20.2 NOTICE OF FORCE MAJEURE.
Each Party agrees to give the other Parties 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
Parties prompt written notice when it is again fully able to perform such
obligations.
20.3 ALLOCATION OF CAPACITY.
If, as a result of a Force Majeure Event, BIP at any time is unable fully
to supply outstanding Firm Orders for Bulk Drug Substance, Drug Product and
Finished Product, as the case may be, BIP shall use reasonable efforts to
equitably allocate its available resources and production capacity among
BIP, Buyer and BIP's other customers, as the case may be, taking into
consideration the respective requirements of each during a reasonable time
period prior to the allocation, as well as such requirements during the
allocation period. BIP shall not grant a higher priority to any Third Party
than to Buyer with respect to shipment of products from the Biberach
Facility.
20.4 TERMINATION.
If, as a result of a Force Majeure Event, BIP is unable fully to perform
its obligations hereunder for any consecutive period of [*] ([*]) days,
unless the Parties mutually agree in writing upon a shorter time period,
Immunex and Wyeth shall have the right to terminate this Agreement in its
entirety, upon providing written notice thereof to BIP, such termination to
be effective [*] ([*]) days from the effective date of such notice. If this
Agreement is terminated pursuant to this Section 20.4, then upon Immunex's
and Wyeth's written request, BIP will provide reasonable assistance to
Immunex and Wyeth in locating an alternative manufacturer for the Product.
Immunex and Wyeth shall reimburse BIP for its reasonable costs incurred in
rendering such assistance.
20.5 REDUCTION IN MAXIMUM REQUEST AND MINIMUM QUANTITY; PRODUCT PRICES; ANNUAL
SURCHARGE.
(a) MAXIMUM REQUEST AND MINIMUM QUANTITY REDUCTION. The Maximum Request
and Minimum Quantity in the applicable Calendar Year(s) shall be
reduced proportionately for the duration of any Force Majeure Event
which prevents BIP from manufacturing Bulk Drug Substance hereunder.
[*]
(b) PRODUCT PRICE ADJUSTMENT. The Product Price set forth in EXHIBIT D,
EXHIBIT E, and EXHIBIT F hereto shall be adjusted proportionately so
that Buyer is not forced to pay a higher Product Price on account of
BIP's inability to manufacture or deliver Bulk Drug Substance, Drug
Product and/or Finished Product hereunder for the duration of any
Force Majeure Event. [*] A comparable adjustment would also be made to
the Product Price for Drug Product and Finished Product under EXHIBIT
E and EXHIBIT F hereto, respectively. [*]
ARTICLE 21. ASSIGNMENT
21.1 ASSIGNMENT.
This Agreement shall be binding upon the successors and assigns of the
Parties and the name of a Party appearing herein shall be deemed to include
the names of its successors and assigns. No Party may assign its interest
under this Agreement without the prior written consent of the other
Parties, such consent not to be unreasonably withheld; provided, however,
any Party may assign its interest under this Agreement, without the prior
written consent of the other Parties, (a) to an Affiliate, so long as the
assigning Party unconditionally guarantees the obligations of such
Affiliate or (b) to a successor of 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 any Party of responsibility for the performance
of any obligation which accrued prior to the effective date of such
assignment.
107
ARTICLE 22. DISPUTE RESOLUTION
22.1 EXCLUSIONS.
Section 22.2 below shall not apply to any disputes arising under Article 16
(Indemnification) or Article 17 (Confidentiality) hereof.
22.2 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 which relates to
a Party's rights and/or obligations hereunder. In the event of the
occurrence of such a dispute, any Party may, by written notice to the other
Parties, have such dispute referred to their respective officers designated
below, or their successors, for attempted resolution by good faith
negotiations within [*] ([*]) days after such notice is received. Such
designated officers are as follows:
For Immunex - Xxxxxxx X. Xxxxxx, Ph.D., Senior Vice President, Drug
Development
For Wyeth - Xxx Xxxxxxxx, Ph.D., Senior Vice President, Quality Assurance
For BIP - Xx. Xxxxxx Xxxxx, member of the BIP board
In the event the designated officers are not able to resolve such dispute
within such [*] ([*])-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.
ARTICLE 23. MISCELLANEOUS
23.1 NOTICES.
Other than notices within the jurisdiction of the respective Business
Coordinators, Technical Coordinators and the Wyeth Representative, which
shall be given to those individuals, any notice required or permitted to be
given hereunder by any 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 Parties set
forth below, or at such other addresses as may from time to time be
furnished by similar notice by any Party. The effective date of any notice
hereunder shall be the date of receipt by the receiving Party.
If to BIP: Boehringer Ingelheim Pharma KG
Birkendorfer Stra(beta)e 65
D-88397 Biberach an der Riss
Federal Republic of Germany
Attention: Xx. Xxxxxxx Xxxxxx
Head of Biopharmaceutical Manufacture
Fax: 0 73 51/54-51 31
Phone: 0 73 51/54-48 00
with a copy to: Boehringer Ingelheim GmbH
Xxxxxx Stra(beta)e 173
X-00000 Xxxxxxxxx
Xxxxxxx Xxxxxxxx of Germany
Attention: Prof. Xx. Xxxx X. Xxxxxx
Head of Industrial Biopharmaceuticals Worldwide
108
If to Immunex: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Southern
Senior Vice President and
Chief Financial Officer
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
If to Wyeth: Wyeth-Ayerst Laboratories
000 X. Xxxxxxxxx
Xx. Xxxxxx, Xxxxxxxxxxxx 00000
Attention: Xxxxxxx XxXxxxxx
Vice President
Global Materials Management
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: American Home Products Corporation
Five Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attention: General Counsel
23.2 APPLICABLE LAW.
This Agreement shall be governed by and construed in accordance with the
laws of the place of domicile of the Party sued (without reference to the
respective choice of law rules) and the courts of the place of domicile of
the Party sued shall have exclusive jurisdiction over all legal matters and
proceedings hereunder. The Parties expressly exclude the application to
this Agreement of the United Nations Convention on Contracts for the
International Sale of Goods.
23.3 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.
23.4 EXHIBITS.
All exhibits referred to herein form an integral part of this Agreement and
are incorporated into this Agreement by such reference.
23.5 SEVERABILITY.
Each Party hereby expressly agrees that it has 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 any 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 enforcement of the remainder does not violate the
Parties' overall intentions in this transaction.
109
23.6 INDEPENDENT CONTRACTORS.
Each of the Parties is an independent contractor and nothing herein
contained shall be deemed to constitute the relationship of partners, joint
venturers, nor of principal and agent between the Parties. No Party shall
hold itself out to Third Parties as purporting to act on behalf of, or
serving as the agent of, any other Party. For purposes of this Section
23.6, Immunex and Wyeth shall be deemed the same Party.
23.7 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.
23.8 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.
23.9 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 (I.E., supply of Product), 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 each of the Parties. 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. This Agreement may be amended and
supplemented only by a written instrument signed by each of the Parties.
23.10 [*]
[This space is intentionally left blank.]
110
IN WITNESS WHEREOF, the Parties 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: By:
-------------------------------- --------------------------------
Xxxxxxx X. Southern Xxxxxx Xxxxxx
Senior Vice President and Executive Vice President
Chief Financial Officer
Date: 12th November 1998 Date: 12th November 1998
BOEHRINGER INGELHEIM PHARMA KG
ppa. ppa.
-------------------------------- --------------------------------
Xx. Xxxxxx Xxxxx Prof. Xx. Xxxx X. Xxxxxx
Member of Board Head of Industrial Biopharmaceuticals
Date: 11th November 1998 Date: 11th November 1998
111
EXHIBIT A
BULK DRUG SUBSTANCE SPECIFICATIONS
The TNFR:Fc Bulk Drug Substance (BDS) is tested according to the test methods
and specifications listed below to provide assurance of quality, potency,
strength, purity, identity and safety, and have been established as required for
material release. The release testing specifications are defined in SOP [*],
Specifications for [*] Bulk Solution (25 mg/mL).
PROCEDURE ACCEPTANCE CRITERIA
--------- -------------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
112
EXHIBIT B
DRUG PRODUCT SPECIFICATIONS
The TNFR:Fc Drug Product is tested according to the test methods and
specifications listed below to provide assurance of quality, potency, strength,
purity, identity, and safety and have been established as required for material
release. The release testing specifications are defined in SOP [*] ([*] mg
dosage form) and [*] (25 mg dosage form).
PROCEDURE ACCEPTANCE CRITERIA
--------- --------------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
113
EXHIBIT C
FINISHED PRODUCT SPECIFICATIONS
Each unique lot of labeled ENBREL(TM) Drug Product is tested according to the
test methods and specifications listed below to provide assurance of product
identity, dosage form and correct vial labeling.
PROCEDURE ACCEPTANCE CRITERIA
[*] [*]
[*] [*]
[*] [*]
114
EXHIBIT D
VOLUME DISCOUNT PRICING MATRIX FOR BULK DRUG SUBSTANCE [*]
See attached.
115
EXHIBIT D
VOLUME DISCOUNT PRICING MATRIX FOR BULK DRUG SUBSTANCE
PRODUCTION ASSUMPTIONS: [*]
IMMUNEX MAXIMUM REQUEST OF CAPACITY PER YEAR FOR [*] BULK
PRODUCTION/SUPPLY PRICE PER GRAM
[*]
116
EXHIBIT E
VOLUME DISCOUNT PRICING MATRIX FOR FILLING AND LYOPHILIZATION
OPERATIONS FOR [*]
See attached.
117
EXHIBIT E
VOLUME DISCOUNT PRICING MATRIX FOR FILLING AND LYOPHILIZATION OPERATIONS FOR
[*]
PRODUCTION ASSUMPTIONS: [*]
[*]
[*]
IMMUNEX REQUEST OF CAPACITY PER YEAR FOR [*]
FILLING/LYOPHILIZATION/SUPPLY PRICE PER VIAL
[*]
* = see Section 5.4 of the agreement
118
EXHIBIT F
VOLUME DISCOUNT PRICING MATRIX FOR LABELING OPERATIONS FOR [*]
See attached.
119
EXHIBIT F
VOLUME DISCOUNT PRICING MATRIX FOR LABELING OPERATIONS FOR [*]
PRODUCTION ASSUMPTIONS: [*]
[*]
[*]
* = see Section 5.4(b) of the agreement
120
EXHIBIT G
FIRM ORDER PLANNING SYSTEM OF [*] COMMERCIAL SUPPLY,
PRE-FDA APPROVAL
See attached.
121
EXHIBIT G
FIRM ORDER PLANNING SYSTEM OF [*] COMMERCIAL SUPPLY
PRE FDA APPROVAL
YEAR [*] [*]
MONTH OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
--------------------- ------ ------- ----- ------ ----- ------- ------- ------- ----- ------ ------ ------ ------ ------ ------
[*]
122
EXHIBIT G
ROLLING FORECAST PLANNING SYSTEM OF [*] COMMERCIAL SUPPLY
PRE FDA APPROVAL
YEAR [*] [*]
MONTH OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
-------------------- ------ ------- ----- ------ ----- ------- ------- ------- ------ ------ ------ ------ ------ ------ ------
[*]
123
EXHIBIT G
ROLLING FORECAST PLANNING SYSTEM OF [*] COMMERCIAL SUPPLY
PRE FDA APPROVAL
YEAR [*] [*]
MONTH OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
-------------------- ------ ------- ----- ------ ----- ------- ------- ------- ------ ------ ------ ------ ------ ------ ------
[*]
124
EXHIBIT H
COORDINATORS AND WYETH REPRESENTATIVE
COORDINATORS
IMMUNEX:
Business Coordinator: Xxxx Xxxxx
Senior Pharmaceutical Planner
Backup Business Coordinator: Xxxx Xxxxx
Enbrel Project Director, Pharmaceutical Development
Technical Coordinator: Xxx Xxxxxxxx
Director of International Quality Operations
Backup Technical Coordinator: Xxxxxxx Xxxxxxxxx
Director of Commercial Quality Operations
BIP:
Business Coordinator: Xxxxxx Xxxxx
Business Economist
Backup Business Coordinator: Xxxxx Xxxxxx
Head of Project Management, Logistic Planning
Technical Coordinator: Xx. Xxxxx Xxxxxxx
Customer Coordinator Technical Affairs
Backup Technical Coordinator: Dr. Xxxxxxxx Xxxx
Head of Protein Chemistry
WYETH REPRESENTATIVE
Wyeth Representative: Xxxxxxx XxXxxxxx
Vice President
Global Materials Management
Backup Wyeth Representative: Xxxxx Xxxx
Senior Director
Strategic Planning
125