Exhibit 10.12
REDACTED VERSION
 
Supply Agreement
Between
SeraCare Life Sciences, Inc.
as SUPPLIER,
INSTITUTO GRIFOLS, S.A. as
MANUFACTURER
and
Wyeth Pharmaceuticals, Inc.
for
Human Serum Albumin *** for cell
culture (Not for Injection) WyethBioPharma
formulation/specifications
 
*** Confidential treatment has been requested as to certain portions of this
agreement. Such omitted confidential information has been designated by an
asterisk and has been filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended, and the Commission’s rules and regulations promulgated under the
Freedom of Information Act, pursuant to a request for confidential
treatment.  ***

-1-

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WYETH BIOPHARMA.
 

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SUPPLY AGREEMENT
 
***Table of Contents***
 

        
Page

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ARTICLE 1.
 
DEFINITIONS
  
1
ARTICLE 2.
 
TERM
  
5
ARTICLE 3.
 
SUPPLY
  
5
ARTICLE 4.
 
PURCHASE ORDERS, FORECASTS AND ***
  
10
ARTICLE 5.
 
PRICE FOR SUPPLY OF PRODUCT
  
12
ARTICLE 6.
 
REGULATORY REQUIREMENTS
  
15
ARTICLE 7.
 
PAYMENT
  
18
ARTICLE 8.
 
SAMPLES, TESTING AND REJECTION
  
18
ARTICLE 9.
 
REPRESENTATIONS, WARRANTIES AND COVENANTS
  
21
ARTICLE 10.
 
PROPRIETARY OWNERSHIP OF INTELLECTUAL PROPERTY
  
23
ARTICLE 11.
 
CONFIDENTIAL INFORMATION
  
24
ARTICLE 12.
 
INDEMNIFICATION
  
27
ARTICLE 13.
 
PATENT INFRINGEMENT INDEMNIFICATION
  
31
ARTICLE 14.
 
GOVERNMENT INSPECTION
  
32
ARTICLE 15.
 
RIGHT TO INSPECT
  
33
ARTICLE 16.
 
RECALL OR SEIZURE
  
34
ARTICLE 17.
 
TERMINATION
  
36
ARTICLE 18.
 
ASSIGNMENT
  
39
ARTICLE 19.
 
COURT PROCEEDING AND GOVERNING LAW
  
40
ARTICLE 20.
 
TAXES AND WITHHOLDING
  
41
ARTICLE 21.
 
FORCE MAJEURE
  
41
ARTICLE 22.
 
SEVERABILITY
  
42
ARTICLE 23.
 
HEADINGS
  
42

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ARTICLE 24.
 
USE OF NAMES
  
42
ARTICLE 25.
 
INDEPENDENT CONTRACTOR
  
43
ARTICLE 26.
 
WAIVER
  
43
ARTICLE 27.
 
PUBLIC DISCLOSURE
  
43
ARTICLE 28.
 
NOTICES
  
44
ARTICLE 29.
 
ACKNOWLEDGEMENT
  
45
ARTICLE 30
 
ENTIRE AGREEMENT
  
46

 
SCHEDULE 1:    INITIAL TWELVE MONTH FORECAST
 
APPENDICES
   

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A.
 
CONFIDENTIALITY AGREEMENT
B.
 
RELEASE CRITERIA, INCLUDING SPECIFICATIONS
C.
 
TECHNICAL AGREEMENT
D.
 
PRICING
E.
 
FORM OF PURCHASE ORDER

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SUPPLY AGREEMENT
 
This Agreement (the “Supply Agreement” or the “Agreement”) entered into this
27th day of September 2002, the “Execution Date,” by and among SeraCare Life
Sciences, Inc., a California Corporation with offices at 1935 Avenida Del Oro,
Suite F, Oceanside, CA 92056, (“SUPPLIER”), Instituto Grifols, S.A., a Spanish
Corporation with offices located at pol. Levante C/Can Guash 2, 08150, Parets
Del Valles (Barcelona) (“MANUFACTURER”), and Wyeth Pharmaceuticals, Inc., acting
through the Wyeth BioPharma unit of its Wyeth Research division (hereinafter
“Wyeth”), with offices at One Burtt Road, Andover, Massachusetts 01810.
 
WHEREAS, MANUFACTURER is a well-known manufacturer of human plasma derived
products with expertise in process optimization and industrialization as well as
cGMP manufacturing.
 
WHEREAS, MANUFACTURER has developed a process to manufacture the PRODUCT (as
defined herein) in commercial scale.
 
WHEREAS, SUPPLIER is the exclusive distributor of the PRODUCT for MANUFACTURER
to Wyeth.
 
WHEREAS, Wyeth is prepared to purchase commercial quantities of PRODUCT from
SUPPLIER on the terms set forth herein.
 
NOW, THEREFORE, in consideration of SUPPLIER’S supply of PRODUCT to Wyeth for
the monetary amounts set forth in this Agreement; and the promises, covenants
and other valuable consideration hereinafter set forth, the parties hereby agree
as follows:
 
Article 1. Definitions
 
As used in this Agreement, the following words and phrases shall have the
following meanings:

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1.01.
 
“Act” shall mean the United States Food, Drug and Cosmetic Act, as amended, and
rules and regulations promulgated thereunder.

 
1.02
 
“Affiliate” of a party hereto shall mean any entity, which controls, is
controlled by, or is under common control with such party. For purposes of this
definition, a party shall be deemed to control another entity, if it owns or
controls, directly or indirectly, more than fifty percent (50%) of the voting
equity of the other entity (or other comparable ownership interest for an entity
other than a corporation), or if it possesses, directly or indirectly, the power
to direct or cause the direction of the management and policies of such other
entity and said power is not restricted by contract.

 
1.03
 
“Certificate of Analysis” or “COA” shall mean the certificate for each batch of
PRODUCT delivered hereunder in substantially the form set forth in the
Specifications.

 
1.04
 
“Confidential Information” shall mean Wyeth Confidential Information, SUPPLIER
Confidential Information or MANUFACTURER Confidential Information.

 
1.05
 
“Confidentiality Agreement” shall mean the Confidentiality Agreement between
MANUFACTURER and Wyeth, as successor to GENETICS INSTITUTE (an original party
thereto), dated July 8, 1999, a copy of which is attached to this Agreement as
Appendix A.

 
1.06
 
“cGMP” or “GMP” shall mean current Good Manufacturing Practice as promulgated by
the United States Food and Drug Administration or applicable international
counterparts.

 
1.07
 
“FINISHED DOSAGE” shall mean all biopharmaceutical formulation as manufactured
by Wyeth utilizing PRODUCT.

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1.08
 
“FDA” shall mean the United States Food and Drug Administration, or any
successor entity thereto.

 
1.09
 
“MANUFACTURER” shall have the meaning set forth in the introductory paragraph of
this Agreement.

 
1.10
 
“MANUFACTURER Confidential Information” shall mean all technical or commercial
information and data provided by MANUFACTURER to Wyeth or SUPPLIER hereunder or,
prior to the date of this Agreement, under the Confidentiality Agreement
including, without limitation, all of the same provided by MANUFACTURER to Wyeth
or provided by MANUFACTURER to SUPPLIER and in turn provided by SUPPLIER to
Wyeth, as contemplated by and subject to and in accordance with Section 11.01
hereof. Upon request from Wyeth, MANUFACTURER shall promptly provide to Wyeth
the technical or commercial information of MANUFACTURER as Wyeth shall require
in order for Wyeth to utilize the PRODUCT as intended by Wyeth, all upon and
subject to the terms hereof as though such information of the MANUFACTURER
constituted MANUFACTURER Confidential Information provided hereunder.

 
1.11
 
“PRODUCT” shall mean MANUFACTURER’s “HUMAN SERUM ALBUMIN *** for cell culture
(Not for Injection) Wyeth formulation/specifications” which is more particularly
described in Appendix B hereof. The current draft of Appendix B, describing the
PRODUCT and setting forth the Specifications (hereinafter defined) and other
matters, is annexed hereto on the Execution Date. MANUFACTURER, SUPPLIER and
Wyeth agree to continue to negotiate in good faith to complete and finalize
Appendix B. When so completed and finalized, such Appendix B shall replace such
current draft thereof as Appendix B to this Agreement and shall be an
inseparable component of and is hereby incorporated into and made an integral
part of this Agreement. References in this Agreement to Appendix B shall mean
and refer to such current draft or such complete and finalized version thereof,
as the case may be.

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***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

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WYETH BIOPHARMA.
 

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1.12
 
“Technical Agreement” shall have the meaning provided in Section 3.02(g) hereof.

 
1.13
 
“Release Criteria” shall mean those criteria that PRODUCT must meet in order to
be acceptable for use by Wyeth. These criteria are: MANUFACTURER shall
manufacture PRODUCT in accordance (i) with applicable FDA and other
international regulatory requirements for PRODUCT meeting the Specifications,
(ii) applicable compulsory regulatory and compliance documentation including
cGMP, (iii) Wyeth’s quality standards set forth in the Technical Agreement which
is Appendix C to this Agreement, (iv) applicable governmental and pharmacopeia
health and safety requirements and standards and (v) the Specifications.

 
1.14
 
“Relevant Statute of Limitations” shall have the meaning provided in Section
9.10 hereof.

 
1.15
 
“Sourcing Date” shall mean the date upon which Wyeth shall commence receiving
commercial quantities of PRODUCT purchased by it hereunder.

 
1.16
 
“Specifications” shall mean the specifications for PRODUCT set forth in Appendix
B, hereof, including sampling, test criteria and procedures contemplated by
Article 8 of this Agreement or otherwise provided therein to be met and
satisfied for purposes of determining that PRODUCT supplied hereunder conforms
to such specifications.

 
1.17
 
“SUPPLIER” shall mean SeraCare Life Sciences, Inc., a California corporation
with corporate offices located at 1935 Avenida Del Oro, Suite F, Oceanside, CA.
92056.

 
1.18
 
“SUPPLIER Confidential Information” shall mean all technical or commercial
information and data provided by SUPPLIER to MANUFACTURER or Wyeth hereunder
including, without limitation, all of the same provided by SUPPLIER to Wyeth or
provided by SUPPLIER to MANUFACTURER and in turn provided by

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MANUFACTURER to Wyeth, as contemplated by and subject to and in accordance with
Section 11.01 hereof.

 
1.19
 
“Wyeth Confidential Information” shall mean all technical or commercial
information and data provided by Wyeth to MANUFACTURER or SUPPLIER hereunder or,
prior to the date of this Agreement, under the Confidentiality Agreement
including, without limitation, all of the same provided by Wyeth to MANUFACTURER
or provided by Wyeth to SUPPLIER and in turn provided by SUPPLIER to
MANUFACTURER, as contemplated by and subject to and in accordance with Section
11.01 hereof.

 
1.20
 
“Wyeth” shall have the meaning provided in the introductory paragraph of this
Agreement.

 
Article 2. Term
 
2.01
 
This Agreement enters into effect on the Execution Date and shall remain in full
force and effect until May 31, 2007, unless sooner terminated in accordance with
Article 17 of this Agreement. Thereafter, it shall be extended from
year-to-year, unless terminated by any party by giving no less than twelve (12)
months prior written notice to the other parties or terminated as provided for
under the terms of Article 17.

 
Article 3. Supply

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3.01
 
SUPPLIER’s Role. The parties acknowledge and agree that SUPPLIER is the sole and
exclusive distributor of human serum albumin produced by MANUFACTURER (including
any Affiliates of MANUFACTURER) for sale to Wyeth (including any Affiliates of
Wyeth) and that Wyeth (including any Affiliates of Wyeth) shall not purchase
from MANUFACTURER (including any Affiliates of MANUFACTURER), and, except
pursuant to this Agreement, MANUFACTURER shall not manufacture for, or supply
to, Wyeth (including any Affiliates of Wyeth), human serum albumin products
(including but not limited to the PRODUCT). It is understood and agreed by the
parties that the purchase and sale of PRODUCT under this Agreement will occur as
follows:

 

 
(i)
 
Wyeth orders PRODUCT from SUPPLIER pursuant to binding purchase orders pursuant
to Section 4.1 of this Agreement;

 

 
(ii)
 
SUPPLIER will, within a maximum period of two days from its receipt of each such
purchase order from Wyeth, submit to MANUFACTURER a corresponding purchase order
for SUPPLIER’S purchase from MANUFACTURER of PRODUCT in quantities and upon
other terms (other than price to SUPPLIER and payment terms pertaining to such
price) identical to those included in the corresponding purchase order from
Wyeth to SUPPLIER;

 

 
(iii)
 
MANUFACTURER will send the corresponding acceptance to SUPPLIER’s purchase order
within a period of four days and will manufacture the PRODUCT as requested
pursuant to SUPPLIER’s purchase order and in accordance with the Release
Criteria and other requirements as set forth in this Agreement;

 

 
(iv)
 
SUPPLIER will arrange with MANUFACTURER for delivery of the underlying PRODUCT
to Wyeth according to the delivery dates and other delivery terms provided in
Wyeth purchase orders to SUPPLIER, and will be responsible for invoicing Wyeth
and collecting payment for the PRODUCT from Wyeth; and

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(v)
 
MANUFACTURER will be responsible for invoicing SUPPLIER and collecting payment
from SUPPLIER for PRODUCT ordered by SUPPLIER.

 
3.02 GENERAL
 
(a)
 
Manufacture and Supply. Wyeth shall purchase PRODUCT in accordance with orders
for PRODUCT submitted to SUPPLIER by Wyeth from time to time during the term of
this Agreement, for use in commercial scale biopharmaceutical production.
MANUFACTURER agrees to manufacture PRODUCT (i) in accordance with the Release
Criteria defined herein, (ii) in accordance with orders for PRODUCT submitted to
MANUFACTURER by SUPPLIER from time to time during the term hereof, and (iii)
otherwise in accordance with the terms, conditions and provisions in this Supply
Agreement, for use in commercial scale biopharmaceutical production.

 
(b)
 
Requirements and Supply Contract. During the term of this Agreement, Wyeth shall
purchase at least *** of its requirements of human serum albumin (including, but
not limited to its requirements for PRODUCT) from SUPPLIER in accordance with
the terms provided herein. MANUFACTURER shall supply to SUPPLIER, for purposes
of such supply by it to Wyeth and to the extent ordered by Wyeth hereunder, up
to *** bottles of PRODUCT per year. To the extent Wyeth’s orders for PRODUCT
hereunder shall exceed such *** bottles per year MANUFACTURER shall use all
commercially reasonable efforts to make and supply such additional PRODUCT to
SUPPLIER for purposes of such supply by SUPPLIER to Wyeth hereunder.

 
(c)
 
Notwithstanding any other provision of this Supply Agreement, if for any reason
whatsoever MANUFACTURER and SUPPLIER shall be unable (or shall be aware of an
anticipated inability) to manufacture or deliver all of Wyeth’s Forecasted
Requirements (defined below) for PRODUCT to Wyeth, SUPPLIER or MANUFACTURER
shall promptly notify Wyeth in writing of such event and of the period for which
such inability (or anticipated inability) to manufacture and

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deliver is expected to exist. If, during any purchase year, MANUFACTURER and
SUPPLIER are unable to supply Wyeth’s requirements for PRODUCT, Wyeth shall be
relieved of its obligation to purchase the PRODUCT impacted on an exclusive
basis from SUPPLIER solely to the extent of and during the period of such
inability to supply said PRODUCT by MANUFACTURER and SUPPLIER. Accordingly
(except where due to force majeure, recall or breach by Wyeth, which are
governed by other provisions of this Agreement), in the event of and during the
period of MANUFACTURER’s and SUPPLIER’s inability to supply at least *** of
Wyeth’s Forecasted Requirements for PRODUCT, Wyeth agrees that MANUFACTURER and
SUPPLIER shall be obligated and be entitled to remedy said inability to supply
by, at the election of Wyeth communicated to SUPPLIER in writing, either:

 

 
(i)
 
if Wyeth advises in writing that it has a qualified third party supplier, by
allowing Wyeth to purchase that portion of its requirements of the affected
PRODUCTS that MANUFACTURER and SUPPLIER are unable to supply, from said third
party supplier during the period of MANUFACTURER’s and SUPPLIER’s inability to
supply the affected PRODUCT hereunder; or

 

 
(ii)
 
if Wyeth advises in writing in good faith that it has no qualified third party
supplier for the affected PRODUCT, by: (A) identifying and cooperating with the
reasonable efforts of Wyeth to qualify a third party supplier of the affected
PRODUCT during the period of MANUFACTURER’s and SUPPLIER’s inability to supply
the affected PRODUCT, ***

 
(d)
 
However, subject to MANUFACTURER’s and SUPPLIER’s duty and right to provide the
foregoing remedies, nothing in this Section 3.02(c) shall be construed

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to limit damages otherwise available, if such inability to supply is due to
material breach by MANUFACTURER and/or SUPPLIER.

 
(e)
 
[Intentionally Omitted]

 
(f)
 
Location of Manufacture. MANUFACTURER agrees to manufacture PRODUCT for Wyeth
only from facilities owned and operated by MANUFACTURER and located at pol.
Levante C/CAN Guash 2 08150 Parets del Valles Barcelona, Spain (the “Facility”).
MANUFACTURER does not have the right, during the term of this Agreement, to
change the location of the Facility without the prior written consent of Wyeth.

 
(g)
 
Technical Agreement The current draft of a separate agreement defining quality
procedures, roles and responsibilities (the “Technical Agreement”) is included
as Appendix C. MANUFACTURER and Wyeth agree to continue to negotiate in good
faith to complete, finalize, execute and deliver the Technical Agreement. When
so completed, finalized, executed and delivered, such Technical Agreement shall
replace such current draft thereof as Appendix C to this Agreement and shall be
an inseparable component of and is hereby incorporated into and made an integral
part of this Agreement.

 
3.03
 
Subject to (i) the restrictions on confidential information set forth in this
Agreement and in the Confidentiality Agreement, (ii) the obligations contained
in Section 3.02(b), and (iii) the restrictions contained in the last sentence of
this Section 3.03, nothing in this Agreement shall preclude Wyeth from
purchasing like or similar PRODUCT from other suppliers or from taking whatever
steps may be necessary or appropriate to qualify alternative suppliers,
including, but not limited to, selling any batches reasonably required to be
manufactured for purposes of the qualification of such alternative suppliers and
maintaining such qualifications. In no event shall Wyeth or any of its
Affiliates (A) sell or convey PRODUCT to any non-Affiliate of Wyeth, except for
the sale in the ordinary course of Wyeth’s business of Finished Dosage, or (B)
share any viral validation

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studies, stability studies or other MANUFACTURER’s Confidential Information or
SUPPLIER Confidential Information with any non-Affiliate of Wyeth.

 
3.04
 
MANUFACTURER agrees to manufacture PRODUCT in accordance with the assurances,
representations, warranties and covenants set forth in the Technical Agreement.
Except as provided in Section 3.02(b) and Article 17, Wyeth shall not be
obligated to purchase PRODUCT for which it has not submitted a Purchase Order.
Notwithstanding anything herein to the contrary, the remedy for Wyeth’s failure
to observe such obligations provided in Section 3.02(b) and Article 17 shall be
such monetary damages to which SUPPLIER or MANUFACTURER may be determined to be
entitled to recover as provided herein.

 
3.05
 
Each delivery of PRODUCT, hereunder, will be delivered, as hereinafter provided,
ex works. MANUFACTURER agrees to include the current Material Safety Data Sheet
(MSDS) and Certificate of Analysis, as required with each delivery, for PRODUCT,
and to comply with the packing and other instructions contained in the Technical
Agreement or otherwise provided by Wyeth. MANUFACTURER agrees to cooperate with
and assist Wyeth, as and to the extent reasonably requested by Wyeth, to prepare
such MSDS.

 
3.06
 
MANUFACTURER will deliver the PRODUCT at the Facility to Wyeth or to such
carrier(s) or agent(s) as shall be designated by Wyeth for the purpose, ex
works, as in accordance with Incoterms 2000 as published by the International
Chamber of Commerce.

 
Article 4. Purchase Orders, Forecasts and ***
 
4.01      Forecast and Purchase Orders.
 

 
(a)
 
Within 90 days prior to the Sourcing Date, Wyeth will provide MANUFACTURER and
SUPPLIER with a twelve (12) month rolling forecast, beginning with the Sourcing
Date, and showing Wyeth’s

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estimated requirements for PRODUCT. Attached hereto as Schedule 1 is the first
such forecast. Beginning with the Sourcing Date, Wyeth will issue on the first
day of the sixth (6th) month of every six-month period, a forecast update for
the subsequent rolling twelve-month period commencing on the first day of the
immediately following calendar month.

 

 
(b)
 
Purchase orders for PRODUCT shall be placed with SUPPLIER by Wyeth, in writing,
in conjunction with forecast updates. All requirements within the first six (6)
months of each forecast shall be firm (the “Forecasted Requirements”) and
represented by the appropriate purchase orders submitted from time to time
during such firm period to SUPPLIER in accordance with the current practices of
the parties. Firm orders (i.e. orders accepted by MANUFACTURER) are legally
binding for all parties in accordance with Section 4.03 of this Agreement.

 

 
(c)
 
Each purchase order submitted by Wyeth to SUPPLIER shall specify the required
quantity and delivery date.

 
***
 

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***

 
4.03
 
Purchase Orders: Form and Binding Effect. Wyeth’s Purchase Orders concerning the
production of PRODUCT made under this Agreement shall be placed with SUPPLIER on
the then standard Wyeth Purchase Order form, a copy of the current form of which
is attached hereto as Appendix E, and shall specify reasonable delivery dates
and instructions for shipping and packaging. If any of the terms of the Purchase
Orders shall conflict with the terms of this Agreement, this Agreement shall
govern. Notwithstanding anything in this Agreement to the contrary, any terms in
a Wyeth Purchase Order that vary from or are in addition to the terms set forth
in Wyeth’s then standard form of purchase order shall not be binding on SUPPLIER
or MANUFACTURER without SUPPLIER’s and MANUFACTURER’s prior written consent.

 
Article 5. PRICE FOR SUPPLY OF PRODUCT
 
5.01
 
Pricing. Wyeth shall purchase PRODUCT on a per *** bottle basis. The pricing for
the PRODUCT is set forth on Appendix D, attached hereto.

 

 
(a)
 
Pricing according Appendix D shall be firm and fixed for the term of the
Agreement, except as hereinafter provided.

 

 
(b)
 
In the event that, at any point during the term of this Agreement:

 

 
(i)
 
SUPPLIER shall sell PRODUCT or like human serum albumin substantially similar to
Wyeth’s existing Specifications (“HSA”) to another customer in annual quantities
smaller than or as large as the annual quantities purchased by Wyeth hereunder
at prices lower than the corresponding prices for such quantities set forth in
Appendix D, the foregoing prices for such quantities of PRODUCT set forth in
Appendix D shall be prospectively, upon thirty (30) days prior written notice to

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SUPPLIER, reduced (x) to the lowest price at which such quantities of PRODUCT,
or (y) by the same percentage reduction in such price of HSA from that set forth
in Appendix D at which such quantities of HSA are sold by SUPPLIER to such other
customer(s); or

 

 
(ii)
 
MANUFACTURER’s variable direct costs of labor or materials incurred in its
manufacture of PRODUCT hereunder shall increase or decrease over that of the
prior year, the price for PRODUCT according to Appendix E shall be
correspondingly increased or decreased during such year but, in the case of any
such increase or decrease, by not more than the percentage increase or decrease
in the U.S. producer price index in such year over the prior year.

 
(c)
 
Notwithstanding any proviso in this Agreement to the contrary, including without
limitation Section 3.02(b):

 

 
***
 

 

 
(ii)
 
If, within thirty (30) days after the notice from Wyeth described in the
foregoing subsection (i), Wyeth, MANUFACTURER and SUPPLIER, notwithstanding good
faith discussions, do not mutually agree on a reduction in such prices to meet
the third party offer, then Wyeth may give MANUFACTURER and SUPPLIER a
suspension notice (a “Suspension Notice”) pursuant to which Wyeth may, beginning
no earlier than six

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months after the date of the Suspension Notice, suspend its obligations to order
its requirements of PRODUCT from SUPPLIER as otherwise provided in this
Agreement, but solely to the extent that Wyeth is able to purchase identical
PRODUCT from such third party at a price below the then applicable price under
this Agreement. Wyeth shall also include in such Suspension Notice a revision to
the forecast provided pursuant to Section 4.01, specifying the quantity of
PRODUCT it expects to order hereunder during the next twelve months and the
quantity of identical PRODUCT that it expects to order from such third party
during the next twelve months. The Forecasted Requirements (and SUPPLIER’s,
MANUFACTURER’s obligations to supply such Forecasted Requirements) shall be
reduced to reflect such revisions.

 

 
(iii)
 
Following provision of any such Suspension Notice, Wyeth may purchase the
applicable PRODUCT from the lower priced source in accordance with its revised
forecast, without breaching the terms of this Supply Agreement. The parties
hereto agree that any Purchase Order submitted by Wyeth to SUPPLIER, and any
PRODUCT made by MANUFACTURER as an obligation under this Agreement (including
but not limited to ***) prior to the date that such Suspension Notice is given
shall not be affected by such Suspension Notice and that the invoice price for
any such PRODUCT shall be equal to the price in effect under this Supply
Agreement at the time when such Purchase Order was issued.

 

 
(iv)
 
If at any time after a Suspension Notice is issued pursuant to the foregoing
subsection (ii), MANUFACTURER, SUPPLIER and Wyeth mutually agree on a reduction
in the price for the applicable PRODUCT, then Wyeth shall withdraw such
Suspension Notice and, subject to fulfillment of Wyeth’s written commitments
with the lower priced source referenced in the foregoing subsection (iii),
Wyeth’s obligation to order all of its requirements of PRODUCT from SUPPLIER and
the obligations of

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MANUFACTURER and SUPPLIER to supply PRODUCT as provided in this Supply Agreement
shall resume.

 

 
(v)
 
If Wyeth does source any PRODUCT from any alternative source as provided in the
foregoing subsections (i), (ii) and (iii) and then subsequently agrees to resume
purchases of such PRODUCT from SUPPLIER in accordance with the foregoing
subsection (iv), then Wyeth shall then have the right to (A) adjust its
forecasts provided under Section 4.01 of this Agreement to reflect commitments
for future purchases made by Wyeth from the alternative source under the
foregoing subsection (iii), and (B) thereafter source such PRODUCT from an
alternative source in accordance with the immediately preceding subsections (i),
(ii) and (iii) subject, again, to subsection (iv) and this subsection (v), and
so on.

 
5.02
 
Process Changes. If either Wyeth or MANUFACTURER identifies process change(s),
which could result in reductions in the cost and, therefore, the price, of the
PRODUCT, MANUFACTURER and Wyeth shall discuss such changes and determine the
feasibility and implications of implementing such change(s).

 
5.03
 
No Liens. At delivery, PRODUCT will be free and clear of any liens or
encumbrances placed thereon, except for liens and encumbrances incurred by
Wyeth.

 
Article 6. Regulatory Requirements
 
6.01      (a)    Although these Registrations do not refer to PRODUCT,
MANUFACTURER maintains product registrations for the therapeutic use of Albumin
(Human) *** in the United States, the European Union and other international
markets. MANUFACTURER agrees to maintain a US and European Drug Master File (DMF
and EDMF respectively) and any corresponding requirement of other applicable
international markets necessary to support these registrations. MANUFACTURER
agrees to

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insure that the manufacturing process used to produce Albumin (Human) *** will
be fully validated. MANUFACTURER agrees to make available for inspection by
Wyeth and the relevant regulatory authorities at the Facility all related
non-proprietary documents or non-proprietary portions of the DMF or EDMF. The
inspection should be notified to MANUFACTURER 30 days in advance of the
projected date or within such shorter period as may be required by the relevant
regulatory authority. This inspection and visit to the facilities is covered by
the Confidentiality Agreement and the provisions of Article 11 hereof.

 

 
(b)
 
MANUFACTURER agrees to prepare batch records and other manufacturing reports
necessary for: (1) the approval of MANUFACTURER as a manufacturer of the PRODUCT
under any and all applicable regulatory requirements, (2) Wyeth to obtain and
maintain in its own name and/or in the name of MANUFACTURER in the US, EU and
other international markets product registrations which refer to or cover
PRODUCT, and (3) the release of PRODUCT by Wyeth. MANUFACTURER agrees to make
all of such reports available to Wyeth as required by law. MANUFACTURER agrees
to make the complete reports, including the raw data, available at the Facility
for review by Wyeth upon request.

 
6.02
 
MANUFACTURER agrees to be responsible for all costs associated with maintaining
proper cGMP, manufacturing standards and documentation requirements, as they may
change from time to time, and as required by the FDA and all applicable
government regulatory agencies for the manufacture of PRODUCT meeting the
Specifications in accordance with section 9.02 of this Agreement.

 
6.03
 
MANUFACTURER agrees to manufacture PRODUCT in compliance with applicable FDA and
other applicable governmental requirements in the US or elsewhere and the
Release Criteria for PRODUCT, or such revised Release

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Criteria as Wyeth provides to MANUFACTURER and SUPPLIER, in writing, and agreed
to by MANUFACTURER and SUPPLIER in writing. The Specifications are attached as
Appendix B and are among the components of the Release Criteria to be complied
with in the manufacture of the PRODUCT.
 

 
6.04
 
MANUFACTURER agrees to manufacture Product using only source plasma collected at
FDA licensed plasma collection centers. MANUFACTURER will confirm that said
plasma collection centers have a current FDA licence at such time when Product
is released for shipment to Wyeth.

 
6.05
 
Source plasma may only be accepted from donors who meet the current FDA
guidelines on donor suitability. All plasma used in the manufacture of Product
must comply with 21 CFR 640 Subpart G, Source Plasma. Furthermore, the source
plasma must comply with the European Pharmacopoeia requirements for “Human
Plasma for Fractionation”.

 
6.06
 
For those procedures to be completed as provided above, MANUFACTURER agrees to
be responsible for all process, analytical method and equipment validation and
to take all commercially reasonable steps necessary to pass government
inspection by the FDA and analogous international authorities for such
procedures where appropriate. MANUFACTURER also agrees to use commercially
reasonable efforts to assist Wyeth in preparing and updating any required
regulatory submissions and all other documents required by the FDA or other
United States or international regulatory agencies from Wyeth in order to obtain
approval of MANUFACTURER as a manufacturer of PRODUCT.

 
6.07
 
MANUFACTURER agrees to test PRODUCT in accordance with, and at the time of
delivery cause PRODUCT to conform to, the Release Criteria and testing methods
as set forth and indicated in Appendix B.

 
6.08
 
For the production of the PRODUCT, MANUFACTURER will rely on the stability
studies performed and provided by Wyeth and, if requested by Wyeth, by

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SUPPLIER. MANUFACTURER agrees to store and ship PRODUCT in an environment
consistent with the storage recommendations as determined by Wyeth’s and, if
requested by Wyeth, by SUPPLIER’s stability program.

 
Article 7. Payment
 
7.01
 
Payment by Wyeth shall be made to SUPPLIER net thirty (30) days from the date of
delivery of the PRODUCTS to the common carrier specified by Wyeth. Shipment
shall be arranged and invoices shall be issued upon MANUFACTURER’s release of
PRODUCT. Payment by SUPPLIER to MANUFACTURER for corresponding PRODUCT ordered
by SUPPLIER from MANUFACTURER shall be made by SUPPLIER to MANUFACTURER net
thirty (30) days from the date of delivery of the PRODUCTS to the common carrier
specified by Wyeth.

 
Article 8. Samples, Testing and Rejection
 
8.01
 
MANUFACTURER agrees to obtain a representative sample from each batch of PRODUCT
produced for Wyeth at the Facility specified in Section 3.02(f). MANUFACTURER
also agrees to supply Wyeth with relevant samples from each batch. MANUFACTURER
agrees to perform the assays and analysis set forth on Appendix B hereto in
strict accordance with the procedures previously agreed upon by the parties and
to promptly supply a Certificate of Analysis in the format required by Wyeth
(attached hereto as Appendix B). Such Certificate of Analysis shall identify the
batch of PRODUCT to which it relates. Wyeth shall perform the assays and
analysis set forth on Appendix B hereto in strict accordance with the procedures
previously agreed upon by the parties.

 
8.02
 
In testing PRODUCT in accordance with this Agreement, MANUFACTURER agrees to use
the analytical testing methods agreed upon by Wyeth and MANUFACTURER. Wyeth
shall also use the analytical testing methods approved by Wyeth. Wyeth shall
analyze a sample of PRODUCT (for purposes of determining whether the same meets
Specifications) within forty-five (45) days

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from the date of receipt of the sample and shall report any adverse findings to
MANUFACTURER and SUPPLIER within forty-five (45) days from such date of receipt
of the sample.

 
8.03
 
All PRODUCT that the parties agree does not meet Release Criteria and is not
capable of being reworked into PRODUCT that meets Release Criteria shall be
disposed of by MANUFACTURER. MANUFACTURER agrees not to ship any PRODUCT for use
by Wyeth pursuant to purchases by it from SUPPLIER pursuant to this Agreement,
which, as indicated by a sample assay or analysis as set forth above, does not
conform to Release Criteria, unless otherwise directed by Wyeth and SUPPLIER.

 
8.04
 
If it is mutually determined by all parties that a particular lot of PRODUCT
does not meet the Release Criteria due to the fault of MANUFACTURER and can not
be reprocessed by an approved route, MANUFACTURER agrees to use commercially
reasonable efforts to replace such lot as quickly as possible at MANUFACTURER’s
expense.

 
8.05
 
If, after shipment to Wyeth, a product failure of the PRODUCT is discovered,
which can not be reprocessed by an approved route, and determined to be the
result of a latent defect that (i) was not or could not have been detected by
MANUFACTURER or by Wyeth using the sampling and testing procedures contemplated
herein or (ii) was due to the failure of MANUFACTURER to adhere to cGMP and/or
Wyeth required procedures, or (iii) was due to the negligence of MANUFACTURER,
then the parties will apply the rules stated in Article 16 hereinbelow.

 
8.06
 
If the analysis or assay of a sample of the PRODUCT performed by or for Wyeth
indicates that the batch of PRODUCT does not meet the Release Criteria and
MANUFACTURER’s analysis or assay of its sample from the same batch indicates
that the batch does meet Release Criteria, or vice versa, Wyeth will so advise
MANUFACTURER and a joint investigation will be conducted to

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determine the cause of the failure. If the investigation proves that the PRODUCT
meets the Release Criteria, then Wyeth shall purchase it as stated in the
present Agreement. If the investigation proves that the PRODUCT does not meet
the Release Criteria, then MANUFACTURER will replace PRODUCT as soon as possible
at the expense of the MANUFACTURER. If the results are not clear, the parties
shall discuss in good faith an equitable solution to the dispute. The cost of
this investigation will be borne by MANUFACTURER and Wyeth 50%-50%.

 
8.07
 
MANUFACTURER agrees that it shall keep plasma pool samples, batch records and
Quality Control documentation related to the lots of PRODUCT manufactured
hereunder according to current regulations for at least one year after the
expiration date of the PRODUCT, for the purposes of responding to requests for
information by Regulatory Authorities and/or assisting Wyeth in any recall of
Finished Dosage, or removal of the PRODUCT from the market. Wyeth shall keep
records relating to Finished Dosage for at least one year after the expiration
date of Finished Dosage for purposes of responding to requests for information
by Regulatory Authorities and/or assisting MANUFACTURER in any recall of
PRODUCT, or removal of PRODUCT from the market.

 
8.08
 
MANUFACTURER further agrees that it shall continue to monitor and maintain post
collection information on donors and post-marketing data on the PRODUCT and its
starting materials (including plasma pools) from the time of collection for a
period of at least seven (7) years from the manufacturing date of the PRODUCT.
Further, MANUFACTURER shall inform Wyeth in the event that any post-donation
information should arise in the monitoring period, which would lead to measures
that under normal circumstances could possibly include the recall of the lot (or
part of the lot). MANUFACTURER shall inform Wyeth of any and all post-donation
information within 3 days of receiving such information from its plasma
suppliers.

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8.09
 
Wyeth agrees to report in writing to MANUFACTURER and SUPPLIER all events
concerning Finished Dosage, which may relate to quality of the PRODUCT.
MANUFACTURER agrees to use commercially reasonable steps necessary to aid Wyeth
to investigate said reports.

 
Article 9. Representations, Warranties and Covenants
 

 
    
 
MANUFACTURER warrants and represents to Wyeth that:

 
9.01
 
MANUFACTURER is cognizant of cGMP as defined in the Act, the Guide to good
manufacturing practice, The Rules Governing Medicinal Products in the European
Union, Volume 4—Good manufacturing practices, 1998 Edition and accepted
internationally. MANUFACTURER agrees to the best of its abilities to manufacture
PRODUCT in a manner which complies with such cGMP guidelines and practices.

 
9.02
 
Change in Process

 

 
(a)
 
Except as otherwise agreed to in writing by the parties, MANUFACTURER agrees not
to materially change the Process, the Specifications, the raw materials used,
the source of the raw materials, the equipment, the site of manufacture, or the
sampling or analytical testing methods or quality standards which are used in
the production of the PRODUCT. A “material” change is defined for this purpose
as any change that, if made to or with respect to Albumin (Human) *** would
require the modification or amendment of an existing Albumin (Human) *** license
or would require notification to the health or other regulatory authorities.
MANUFACTURER further agrees that it will not modify or change any part of the
Release Criteria or Technical Agreement.

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(b)
 
MANUFACTURER agrees to provide Wyeth with a detailed written report of all
material changes as identified in Section 9.02(a) that require Health
Authorities or International Regulatory Approval prior to implementation.

 
9.03
 
If Wyeth is required by the FDA or some other United States or international
regulatory agency to change, with respect to PRODUCT, the Specifications, the
raw materials, sources of raw material, or the sampling or analytical testing
methods or quality standards which are a part of the Release Criteria or
Technical Agreement, MANUFACTURER agrees to use commercially reasonable efforts
to accommodate all such requirements, but at Wyeth’s cost and expense insofar as
and to the extent that Wyeth’s unique requirements need to be so accommodated.

 
9.04
 
If Wyeth requests, in writing, a change, with respect to the PRODUCT, in the
Process, the Specifications, the raw materials, source of raw material, or the
sampling or analytical testing methods or quality standards which are a part of
the Release Criteria or the Technical Agreement, that is not the result of a
requirement of FDA or some other United States or international regulatory
agency, MANUFACTURER agrees to use reasonable efforts to accommodate such
request, at Wyeth’s cost and expense.

 
9.05
 
If MANUFACTURER requests, in writing, a change, with respect to the PRODUCT, in
the Process, the Specifications, the raw materials, source of raw material, or
the sampling or analytical testing methods or quality standards which are a part
of the Release Criteria or the Technical Agreement, that is not the result of a
requirement of FDA or some other United States or international regulatory
agency, Wyeth shall use reasonable efforts to accommodate such request, at
MANUFACTURER’s cost and expense.

 
9.06
 
Each party agrees to promptly forward to the other parties copies of any written
communication received by such party from the FDA or other United States or
international regulatory agency, which will affect the manufacture of PRODUCT

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and/or Finished Dosage, as contemplated herein, and shall promptly advise the
other parties of any such information.

 
9.07
 
MANUFACTURER agrees to conduct its PRODUCT manufacturing operations hereunder in
compliance with all applicable laws and regulations including, but not limited
to, those dealing with occupational safety and health, those dealing with public
safety and health, those dealing with protecting the environment, and those
dealing with disposal of wastes.

 
9.08
 
MANUFACTURER agrees to report to Wyeth and SUPPLIER, as soon as possible, all
incidents that result in regulatory, safety, health or environmental audits.

 
9.09
 
MANUFACTURER warrants that to its knowledge, it has not used nor will it use in
any capacity the services of any person debarred under the Generic Drug
Enforcement Act, 21 USC §335a(k)(1), and further to its knowledge, MANUFACTURER
has not used any person who has been convicted of a crime as defined under the
Generic Drug Enforcement Act in connection with the services rendered to Wyeth.
Before so using any services or person, MANUFACTURER agrees to use all
commercially reasonable efforts to determine and satisfy itself that such person
has not been so debarred or convicted.

 
9.10
 
The provisions of this Article 9 shall survive termination of this Agreement
until the expiration of the statute of limitations relevant to claims which may
be asserted against Wyeth or which according to the laws of the United States,
may be asserted by Wyeth hereunder, whichever is longer, (the “Relevant Statute
of Limitations”) all as determined by a court of competent jurisdiction in the
United States to which the same may be submitted.

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Article 10.        Proprietary Ownership of Intellectual Property
 
10.01
 
None of the parties shall be deemed by this Agreement to have been granted or
received any license or other rights to presently existing patent rights,
know-how, trademarks, tradenames or copyrights relating to PRODUCT or
formulations containing PRODUCT, or existing processes which are owned by Wyeth,
SUPPLIER or MANUFACTURER (the “Product IP”). To the extent that Wyeth, SUPPLIER
or MANUFACTURER possess such rights in the Product IP, they each hereby grant to
the other parties hereto such licenses and rights to the Product IP only to such
limited extent as may be necessary or appropriate for such other parties to
manufacture and supply PRODUCT hereunder and for Wyeth to use, apply and sell
PRODUCT and/or develop, make, have made, use and sell other formulations or
products of which the PRODUCT may be a component or in or with respect to which
the PRODUCT may be incorporated, integrated or used (“Finished Dosage”) or to
use in and for any and all other lawful uses and purposes as Wyeth may determine
in its sole discretion.

 
Article 11.        Confidential Information
 
11.01
 
It is contemplated that in the course of performance of this Agreement each
party may, from time to time, disclose Confidential Information to the other(s).

 

 
(a)
 
MANUFACTURER agrees, on behalf of itself, its employees and agents, that during
the term of this Agreement and for a period of five (5) years thereafter, it
will not disclose to others or use for its own benefit or for the benefit of a
third party, except as provided herein, Wyeth Confidential Information or
SUPPLIER Confidential Information. MANUFACTURER further agrees to limit access
to Wyeth Confidential Information and SUPPLIER Confidential Information to its
employees or agents who need to know such Confidential Information for the
purpose of producing PRODUCT under this Agreement and who, prior to affording
them such access, are bound, by written agreement or otherwise for the benefit
of MANUFACTURER, SUPPLIER and Wyeth, to perform and observe the obligations of
MANUFACTURER under this Section 11.01(a).

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(b)
 
Wyeth agrees, on behalf of its employees and agents, that during the term of
this Agreement and for a period of five (5) years thereafter, it will not
disclose to others or use for its own benefit or for the benefit of a third
party, except as provided herein, MANUFACTURER Confidential Information or
SUPPLIER Confidential Information. Wyeth further agrees to limit access to
MANUFACTURER Confidential Information and SUPPLIER Confidential Information to
its employees or agents who need to know such Confidential Information with
respect to the production or registration of PRODUCT and who, prior to affording
them such access, are bound, by written agreement or otherwise for the benefit
of Wyeth, MANUFACTURER and SUPPLIER, to perform and observe the obligations of
Wyeth under this Section 11.01(b).

 
(c)
 
SUPPLIER agrees, on behalf of itself, its employees and agents, that during the
term of this Agreement and for a period of five (5) years thereafter, it will
not disclose to others or use for its own benefit or for the benefit of a third
party, except as provided herein, Wyeth Confidential Information or MANUFACTURER
Confidential Information. SUPPLIER further agrees to limit access to Wyeth
Confidential Information and MANUFACTURER Confidential Information to its
employees or agents who need to know such Confidential Information for the
purpose of supplying PRODUCT under this Agreement and who, prior to affording
them such access, are bound, by written agreement or otherwise for the benefit
of SUPPLIER, MANUFACTURER and Wyeth, to perform and observe the obligations of
SUPPLIER under this Section 11.01(c).

 
(d)
 
However, the provisions of (a), (b), and (c) herein shall not apply to:

 

 
(i)
 
information or data, which were already known by the receiving party at the time
of its disclosure as evidenced by its written records;

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(ii)
 
information or data disclosed to the receiving party by a third party lawfully
in possession of such information and not known by the receiving party, after
reasonable inquiry with respect thereto, to be under an obligation of
nondisclosure to the disclosing party in respect thereof;

 

 
(iii)
 
information or data, which at the time of disclosure are or which subsequently
become patented, published or otherwise part of the public domain except by
breach of this Agreement by the receiving party;

 

 
(iv)
 
information or data, which are required to be submitted to the FDA or other
regulatory authorities in order to carry out the purposes of this Agreement,
provided that any disclosure is made in accordance with Section 11.02 herein; or

 

 
(v)
 
information or data that is developed by the receiving party, independently or
jointly with others, without use of or access to the disclosing party’s
Confidential Information as evidenced by the receiving party’s written records.

 
11.02
 
In the event that a party is required by government rule or regulation to
disclose Confidential Information of one or both of the other parties, the party
required to make such disclosure shall promptly notify the other parties of such
required disclosure and shall, to the extent reasonably possible, give the other
parties an opportunity to review and comment on such disclosure prior to making
such required disclosure and to object to some or all of such disclosure and/or
obtain a protective order with respect thereto.

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11.03    (a)
 
Any and all Confidential Information in tangible form passed to any of the
parties hereunder or for purposes hereof shall, on request, be immediately
returnable to the disclosing party.

 

 
(b)
 
The Confidential Information passed to the other party hereunder or for purposes
hereof shall not be used by the receiving party except as permitted under the
terms of this Agreement.

 
11.04
 
The confidentiality obligations contained in this Article 11 shall survive the
termination of this Agreement for a period of five years.

 
Article 12.    Indemnification
 
12.01
 
Wyeth shall indemnify, defend and hold harmless SUPPLIER and MANUFACTURER, and
SUPPLIER’s and MANUFACTURER’s officers, directors, agents, servants, and
employees from and against any and all claims, losses, damages, liabilities,
costs and expenses, including reasonable legal expenses, arising out of or in
connection with (a) a material breach by Wyeth of its duties under this
Agreement, (b) the matters set forth in Section 12.06, (c) any misrepresentation
or breach of warranty by Wyeth contained herein, and (d) except to the extent
primarily attributable to the PRODUCT as sold to Wyeth hereunder, any claim,
lawsuit or other action by a third party caused by the manufacture, use or sale
of Finished Dosage to the extent primarily attributable to actions taken by
Wyeth hereunder in violation of its obligations under this Agreement.

 
12.02    (a)
 
Wyeth shall be under no obligation to indemnify, defend, and hold harmless
SUPPLIER regarding claims, losses, damages, liabilities, cost and expenses which
are directly and primarily attributable to:

 

 
(i)
 
the wilful misconduct of SUPPLIER or its agents or employees;

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(ii)
 
SUPPLIER’s material breach of this Agreement; or

 

 
(iii)
 
the material failure of SUPPLIER or its employees to comply with applicable law
or regulations.

 
(b)
 
Wyeth shall be under no obligation to indemnify, defend, and hold harmless
MANUFACTURER regarding claims, losses, damages, liabilities, cost and expenses
which are directly and primarily attributable to:

 

 
(i)
 
the wilful misconduct of MANUFACTURER or its agents or employees;

 

 
(ii)
 
MANUFACTURER’s material breach of this Agreement; or

 

 
(iii)
 
the material failure of MANUFACTURER or its employees to comply with applicable
law or regulations.

 
12.03
 
SUPPLIER and MANUFACTURER agree to notify Wyeth of any claim which SUPPLIER or
MANUFACTURER has or might assert under Section 12.01 promptly upon learning of
the event or circumstance giving rise or which might give rise to such claim and
determining that such event or circumstance might so give rise to such claim,
provided that the failure so to provide such notice promptly shall not prejudice
or adversely affect any such claim of SUPPLIER or MANUFACTURER hereunder.
SUPPLIER and MANUFACTURER agree, at Wyeth’s cost, to permit Wyeth’s attorneys to
handle, control and settle such third-party claims or suits as are described or
included in Section 12.01; provided, however that Wyeth will not enter into any
settlement that would adversely effect SUPPLIER or MANUFACTURER without
SUPPLIER’s or MANUFACTURER’s consent, which shall not be unreasonably withheld.
SUPPLIER and MANUFACTURER agree to provide Wyeth with reasonable assistance in
defending such claim at Wyeth’s cost and expense. In the event that Wyeth has

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elected to handle and control the defence of such claim, SUPPLIER and
MANUFACTURER may each participate in such action at its own expense.

 
12.04
 
SUPPLIER shall indemnify, defend and hold harmless Wyeth, and Wyeth’s officers,
directors, agents, servants, and employees from and against any and all claims,
losses, damages, liabilities, costs and expenses, including reasonable legal
expenses, arising out of or in connection with (a) a material breach by SUPPLIER
of its duties under this Agreement, (b) the matters set forth in Section
12.02(a), (c) any misrepresentation or breach of warranty by SUPPLIER contained
herein, and (d) except to the extent primarily attributable to actions taken by
Wyeth with respect to the PRODUCT, any claim, lawsuit or other action by a third
party caused by the use or sale of PRODUCT by Wyeth in accordance with the terms
of this Agreement to the extent primarily attributable to actions taken by
SUPPLIER hereunder in violation of its obligations under this Agreement.

 
12.05
 
MANUFACTURER shall indemnify, defend and hold harmless Wyeth, and Wyeth’s
officers, directors, agents, servants, and employees from and against any and
all claims, losses, damages, liabilities, costs and expenses, including
reasonable legal expenses, arising out of or in connection with (a) a material
breach by MANUFACTURER of its duties under this Agreement, (b) the matters set
forth in Section 12.02(b), (c) any misrepresentation or breach of warranty by
MANUFACTURER contained herein, and (d) except to the extent primarily
attributable to actions taken by Wyeth with respect to the PRODUCT, any claim,
lawsuit or other action by a third party caused by the use or sale of PRODUCT by
Wyeth in accordance with the terms of this Agreement to the extent primarily
attributable to actions taken by MANUFACTURER hereunder in violation of its
obligations under this Agreement.

 
12.06
 
SUPPLIER and MANUFACTURER shall be under no obligation to indemnify, defend, and
hold harmless Wyeth regarding claims, losses, damages, liabilities, cost and
expenses which are directly and primarily attributable to:

 

 
(i)
 
the wilful misconduct of Wyeth, or its agents or employees;

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(ii)
 
Wyeth’s material breach of this Agreement; or

 

 
(iii)
 
the material failure of Wyeth or its employees to comply with applicable law or
regulations.

 
12.07
 
Wyeth agrees to notify SUPPLIER of any claim which Wyeth has or might assert
under Section 12.04 promptly upon learning of the event or circumstance giving
rise or which might give rise to such claim and determining that such event or
circumstance might so give rise to such claim, provided that the failure so to
provide such notice promptly shall not prejudice or adversely affect any such
claim of Wyeth hereunder. Wyeth agrees, at SUPPLIER’s cost, to permit SUPPLIER’s
attorneys to handle, control and settle such third-party claims or suits as are
described or included in Section 12.04; provided, however that SUPPLIER will not
enter into any settlement that would adversely effect Wyeth without Wyeth’s
consent, which shall not be unreasonably withheld. Wyeth agrees to provide
SUPPLIER with reasonable assistance in defending such claim at SUPPLIER’s cost
and expense. In the event that SUPPLIER has elected to handle and control the
defence of such claim, Wyeth may participate in such action at its own expense.

 
12.08
 
Wyeth agrees to notify MANUFACTURER of any claim which Wyeth has or might assert
under Section 12.05 promptly upon learning of the event or circumstance giving
rise or which might give rise to such claim and determining that such event or
circumstance might so give rise to such claim, provided that the failure so to
provide such notice promptly shall not prejudice or adversely affect any such
claim of Wyeth hereunder. Wyeth agrees, at MANUFACTURER’s cost, to permit
MANUFACTURER’s attorneys to handle, control and settle such third-party claims
or suits as are described or included in Section 12.05; provided, however that
MANUFACTURER will not enter into any settlement that would adversely effect
Wyeth without Wyeth’s consent, which shall not be unreasonably withheld. Wyeth
agrees to provide MANUFACTURER with reasonable assistance in defending such
claim at MANUFACTURER’s cost and expense. In the event

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that MANUFACTURER has elected to handle and control the defence of such claim,
Wyeth may participate in such action at its own expense.

 
12.09
 
Each of MANUFACTURER, SUPPLIER and Wyeth agree to obtain and maintain, at all
times during the term of this Agreement, commercial general liability insurance,
including product liability insurance, with reputable and financially secure
insurance carriers, with limits of not less than seven million dollars
($7,000,000) per occurrence and seven million dollars ($7,000,000) in the
aggregate, in either case to cover their respective indemnification obligations
under this Agreement. Each party shall furnish to the other party upon request,
certificates of such insurance in force from time to time during the term
hereof, including renewals and replacements of such coverage.

 
12.10
 
The indemnification obligations set forth in this Article 12 shall survive the
termination of this Agreement until the expiration of the Relevant Statute Of
Limitations. [See Section 9.10]

 
12.11
 
None of the parties to this Agreement shall be entitled to recover from any
other party any special, incidental, consequential or punitive damages nor shall
any party be liable for indemnification to any of the other parties on account
of any claim asserted for special, incidental, consequential or punitive
damages, including without limitation, lost profits, except in the case of a
wilful and bad faith repudiation of this Agreement.

 
12.12
 
Notwithstanding anything in this Agreement to the contrary, the sole remedy to
Wyeth for any recall or seizure based on or arising out of defects in the
PRODUCT shall be as set forth in Article 16.

 
Article 13.        Patent Infringement Indemnification
 
13.01
 
SUPPLIER and MANUFACTURER, jointly and severally, shall indemnify, defend and
hold Wyeth harmless and accept all legal and financial responsibility for any
liability, damage, loss, cost or expense arising out of any patent infringement
claims against Wyeth in respect of the manufacture,

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sale or use of the PRODUCT. Wyeth shall promptly notify SUPPLIER and
MANUFACTURER, in writing, of said claims and at MANUFACTURER’s and SUPPLIER’s
cost, permit MANUFACTURER’s and SUPPLIER’s attorneys to handle and control such
claims or suits. Wyeth may participate in any such action at its own expense.

 
13.02
 
The Patent Infringement Indemnification terms set forth in Article 13 shall
survive the termination of this Agreement until the expiration of the Relevant
Statute Of Limitations

 
13.03
 
Article 13 will be interpreted and applied in accordance with Article 29. The
declarations and acknowledgments stated in said Article will also be applicable
in any case of patent infringement.

 
Article 14.        Government Inspection
 
14.01
 
MANUFACTURER agrees to notify Wyeth and SUPPLIER via facsimile within five (5)
business days of notification of any pending or ongoing FDA or government
inspection related to the manufacture of PRODUCT or the facilities used to
produce, test or warehouse PRODUCT. MANUFACTURER agrees to inform Wyeth and
SUPPLIER of any FDA Form 483 Observations, Warning Letters or associated
material correspondence to and received from the FDA within seven (7) days of
receipt. Further, MANUFACTURER agrees to make such correspondence available for
inspection by Wyeth during their audits.

 
14.02
 
Wyeth agrees to notify MANUFACTURER and SUPPLIER via facsimile within five (5)
business days of notification of any pending or ongoing FDA or government
inspection related to the facilities used to test or warehouse PRODUCT. Wyeth
agrees to inform SUPPLIER and MANUFACTURER of any FDA Form 483 Observations,
Warning Letters or associated material correspondence to and received from the
regulatory agency within seven (7)

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days of receipt. Further Wyeth agrees to make such correspondence available for
inspection by MANUFACTURER during their audits.
 
Article 15.    Right to Inspect
 
15.01
 
In performing manufacturing hereunder, MANUFACTURER agrees to:

 

 
(i)
 
permit Wyeth or its designated representative to inspect on an annual basis (and
more frequently upon reasonable request by Wyeth) that portion of the Facility
where PRODUCT is manufactured, tested or stored to evaluate MANUFACTURER’s work
practices, supporting systems, documents and records associated with PRODUCT,
and make such copies of such documents and records as may be reasonably
necessary and appropriate, for the purpose of assessing the MANUFACTURER’s
compliance with applicable regulations and cGMP as described and provided in the
Act. Such review shall be conducted upon reasonable prior notice by Wyeth, but
not less than sixty (60) days prior to the inspection and shall be during normal
business hours;

 

 
(ii)
 
to the extent Wyeth has reasonable, objective cause to believe that MANUFACTURER
is in material breach of its obligations hereunder and such breach threatens
Wyeth’s regulatory license to use PRODUCT manufactured by MANUFACTURER, permit
Wyeth or its designated representative to inspect, on an as needed basis, that
portion of the Facility where PRODUCT is manufactured, tested or stored to
evaluate MANUFACTURER’s work practices, supporting systems, documents and
records associated with PRODUCT and make copies of such documents and records as
may be reasonably necessary and appropriate for the purpose of assessing
MANUFACTURER’s compliance with applicable regulations and cGMP as described and
provided in the Act. Such

 

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review shall be conducted upon reasonable prior notice by Wyeth, and shall be
during normal business hours; and

 

 
(iii)
 
identify to Wyeth, upon request, in list form all haulers, brokers and disposal
sites utilized for disposal of waste material generated in connection with the
manufacture of PRODUCT. MANUFACTURER agrees to permit Wyeth or its designated
representative to visit all disposal sites for hazardous waste generated in
connection with the producing, packaging, and testing of PRODUCT. Such visits
shall be on dates agreeable to Wyeth, MANUFACTURER, as applicable, and their
respective environmental health and safety groups.

 
15.02
 
The parties shall keep each other reasonably informed of the steps taken by a
party to resolve any outstanding issues with the FDA or international regulatory
authorities and the anticipated timetable of resolution of such issues as it
applies to PRODUCT or the manufacture of PRODUCT.

 
15.03
 
To the extent required, Wyeth shall allow SUPPLIER and MANUFACTURER to inspect
Wyeth’s facilities where products incorporating or using the PRODUCT are
manufactured, tested or stored to ensure compliance by Wyeth with the terms of
this Agreement. Such review shall be conducted upon reasonable prior notice by
SUPPLIER and MANUFACTURER, and shall be during normal business hours.

 
15.04
 
Any failure by the parties to comply with the requirements of this Article 15
shall be subject to the remedy rights set forth in Article 17 of this Agreement.

 
15.05
 
Any visit or information stated in this Article will also be covered by the
Confidentiality Agreement and by Article 11 as specified in the present
Agreement.

 

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Article 16.    Recall or Seizure
 
16.01
 
Each party shall keep the other parties fully informed of any notification or
other information relating to the manufacture, use or sale of PRODUCT or
Finished Dosage that it receives or learns of, whether received directly or
indirectly, which such party believes will probably result in the “recall” or
“seizure” of PRODUCT or of Finished Dosage.

 
16.02
 
In the event of any “recall” or “seizure” arising out of or resulting from a
latent defect in PRODUCT that (i) could not have been detected by Wyeth using
the testing contemplated by the Release Criteria, and (ii) was due to the
failure of MANUFACTURER to adhere to cGMP and/or Wyeth required procedures, or
(iii) was due to the negligence of MANUFACTURER (PRODUCT that is recalled or
seized and meets the requirements of clause (i) and either clause (ii) or clause
(iii) of this paragraph is referred to herein as the “Recalled Product”, and
Finished Dosage that is recalled or seized because it contains PRODUCT that
meets the requirements of clause (i) and either clause (ii) or clause (iii) of
this paragraph is referred to herein as the “Recalled Finished Dosage”),
MANUFACTURER agrees (1) to use commercially reasonable efforts to supply
PRODUCT, without charge to Wyeth, in an amount sufficient to replace (a) the
amount of Recalled Product and (b) the amount of defective PRODUCT contained in
Recalled Finished Dosage (i.e., MANUFACTURER shall only be obligated to replace
that portion of the PRODUCT contained in the Recalled Finished Dosage that meets
the requirements of clause (i) and either clause (ii) or clause (iii) of this
paragraph, but not that portion of PRODUCT contained in the Recalled Finished
Dosage that is otherwise compliant), and (2) in MANUFACTURER’s sole discretion,
either:

 
(x)  reimburse Wyeth for all transportation costs, export or duties and other
out-of-pocket expenses incurred by Wyeth in obtaining or replacing Recalled
Product pursuant to clause 1(a) or (b) of this Section 16.02, all to the extent
not recovered by Wyeth in respect of such Recalled Product or Recalled Finished
Dosage; or

 

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(y)  refund to Wyeth, or give credit to Wyeth against outstanding receivables
due from Wyeth or against the price of PRODUCT to be delivered to Wyeth in the
future, in amounts equal to the price paid by Wyeth for Recalled Product and the
PRODUCT contained in the Recalled Finished Dosage plus transportation costs,
export or import duties and other out-of-pocket expenses incurred by Wyeth in
obtaining or replacing PRODUCT hereunder and in connection with such recall or
seizure.
 
16.03
 
Wyeth shall notify SUPPLIER and MANUFACTURER and SUPPLIER and MANUFACTURER shall
notify Wyeth of any recall or seizure that is likely to involve the PRODUCT,
promptly following the time Wyeth or SUPPLIER and MANUFACTURER, as applicable,
becomes aware of the reasonable likelihood of such recall or seizure.

 
16.04
 
For purposes of this Article 16, “recall” shall mean any action by Wyeth or any
Affiliate or subsidiary of Wyeth to recover title to or possession of PRODUCT or
Finished Dosage containing PRODUCT sold or shipped to third parties as a direct
and primary result of the discovery of a material defect in the PRODUCT not
known to Wyeth at the time of the sale of the PRODUCT or Finished Dosage to such
third parties. The term “recall” also includes the failure by Wyeth to sell or
ship PRODUCT or Finished Dosage containing PRODUCT to third parties, which would
have been subject to recall if it had been sold or shipped. For purposes of this
Article 16, “seizure” shall mean any action by any government agency to detain
or destroy PRODUCT or Finished Dosage containing PRODUCT or prevent release of
PRODUCT or Finished Dosage containing PRODUCT.

 

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Article 17.    Termination
 
17.01
 
Upon the occurrence of the following events, a party (other than the party to
whom the respective clause below relates) may terminate this Agreement by giving
the other parties ninety- (90) day’s prior written notice:

 

 
(a)
 
in the case that a party is unable to pay its debts, becomes bankrupt or
insolvent or enters into liquidation, whether compulsory or voluntary, or has a
receiver appointed over all or part of its assets, or takes or suffers any
similar action in consequence of a debt, or ceases for any reason to carry on
business; or

 

 
(b)
 
upon the breach of any material provision of this Agreement by a party, if the
breach is not cured within ninety (90) days after written notice thereof, and
the material breach continues to exist at the effective time of termination.

 
  
 
If it is the SUPPLIER who incurs any of the above-mentioned circumstances, the
Agreement shall be automatically assigned to MANUFACTURER or any new supplier
MANUFACTURER may appoint and which fully assumes all of the roles,
responsibilities and obligations of SUPPLIER hereunder.

 
17.02  (a)
 
Wyeth may terminate this Agreement at any time by giving one year written notice
to SUPPLIER and MANUFACTURER in the following circumstances:

 

 
(i)
 
if Wyeth, in its sole discretion, determines that it will no longer develop or
market Finished Dosage;

 

 
(ii)
 
or if the FDA and/or any analogous international regulatory authority puts a
clinical hold on the Finished Dosage containing PRODUCT or withdraws approval of
the manufacture, testing, or marketing of the Finished Dosage containing
PRODUCT; or

 

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(iii)
 
if the FDA and/or any analogous international regulatory agency that regulates
PRODUCT takes any action, the result of which is to prohibit the manufacture,
sale or use or any similar action of PRODUCT or the FDA or any other
international regulatory agency imposes significant restriction on the marketing
of PRODUCT.

 

 
(b)
 
Should Wyeth terminate this Agreement due to any of the reasons contained in
Section 17.02(a), MANUFACTURER agrees to take commercially reasonable measures
to cease any ongoing production and limit further expenses associated with such
ongoing production.

 

 
(c)
 
In recognition of the costs that will be incurred by MANUFACTURER to manufacture
and maintain PRODUCT *** pursuant to SUPPLIER purchase orders based on Wyeth’s
Purchase Orders in the event of termination of this Agreement for any reason,
Wyeth shall be responsible for the payment of *** all commitments made by Wyeth
by way of Purchase Orders; provided and only to the extent that MANUFACTURER
shall have failed, after the use of commercially reasonable efforts, to use or
dispose of the same to others.

 
17.03
 
If Wyeth has not ordered PRODUCT hereunder for at least three (3) consecutive
years, then (a) SUPPLIER may terminate this Agreement by giving thirty (30) days
prior written notice to Wyeth, and (b) Wyeth may terminate this Agreement by
giving thirty (30) days prior written notice to SUPPLIER.

 
17.04
 
Termination, expiration, cancellation or abandonment of this Agreement through
any means and for any reason, except as expressly provided above, shall not
relieve the parties of any obligation accruing prior thereto or subsequent
thereto with respect to PRODUCT received by Wyeth prior thereto, including but
not

 

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***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

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limited to, the confidentiality and proprietary ownership provisions herein and
the obligation to pay money, and shall be without prejudice to the rights and
remedies of each party with respect to the antecedent breach of any of the
provisions of this Agreement. In addition, and without limiting the generality
of the foregoing, the following provisions shall survive termination,
expiration, cancellation or abandonment of this Agreement until the expiration
of the Relevant Statute Of Limitations: Articles 3, 6, 7, 8 and 9 with respect
to PRODUCT received by Wyeth prior to such termination and with respect to
PRODUCT which Wyeth elects, in its sole discretion, to receive, after such
termination, Articles 10, 11, 12, 13, 14, 16 and, insofar as applicable Articles
19 through 30.

 
17.05
 
Upon termination or cancellation of this Agreement for any reason, each party
who received Confidential Information from another party pursuant to this
Agreement shall promptly transfer to the disclosing party any and all
Confidential Information provided by the disclosing party. One copy of such
Confidential Information may be retained by the legal department of the
receiving party for archival purposes.

 
Article 18.    Assignment
 
18.01
 
This Agreement may not be assigned or transferred by SUPPLIER without the prior
written consent of Wyeth and MANUFACTURER; provided, however, that SUPPLIER may
assign its rights and duties hereunder without such consent to any Affiliate of
SUPPLIER, or to any party or entity which acquires all or substantially all of
the business or assets of SUPPLIER related to this Agreement, if (1) the
acquiring party expressly assumes, in writing, SUPPLIER’s obligations hereunder,
and (2) the acquiring party assumes, to the reasonable satisfaction of
MANUFACTURER, all of SUPPLIER’s roles, responsibilities and obligations under
SUPPLIER’s contractual arrangements with MANUFACTURER.

 

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18.02
 
This Agreement may not be assigned or transferred by MANUFACTURER without the
prior written consent of Wyeth and SUPPLIER; provided, however, that
MANUFACTURER may assign its rights and duties hereunder without such consent to
any Affiliate of MANUFACTURER, or to any party or entity which acquires all or
substantially all of the business or assets of MANUFACTURER related to this
Agreement if (1) the acquiring party expressly assumes, in writing,
MANUFACTURER’s obligations hereunder, (2) Wyeth determines, in its judgment
reasonably exercised, that the acquiring party is fully licensed or approved as
a manufacturer of PRODUCT under any and all applicable regulatory requirements
and is otherwise capable, without more, to perform and observe all of
MANUFACTURER’s roles, responsibilities and obligations under this Agreement to
at least the same level and extent as MANUFACTURER, and (3) the acquiring party
assumes, to the reasonable satisfaction of SUPPLIER and Wyeth, all of
MANUFACTURER’s roles, responsibilities and obligations under MANUFACTURER’s
contractual arrangements with SUPPLIER.

 
18.03
 
This Agreement may not be assigned or transferred by Wyeth without the prior
written consent of SUPPLIER and MANUFACTURER; provided, however, that Wyeth may
assign its rights and obligations hereunder without such consent (a) to an
Affiliate of Wyeth, provided that in the event that such Affiliate does not
thereafter purchase PRODUCT hereunder in annual quantities at least as great as
that which would have been required, pursuant to Section 3.02(b), to have been
purchased by Wyeth hereunder but for such assignment, then Wyeth shall purchase
sufficient PRODUCT to make up such shortfall during the remainder of the term of
this Agreement; or (b) to a successor of Wyeth’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 be bound by the obligations
of this Agreement.

 

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Article 19.    Court Proceeding and Governing Law
 
19.01
 
If any dispute, controversy or difference arises out of or in connection with
this Agreement, the parties hereto shall use their best efforts to settle such
dispute, controversy or difference amicably.

 
  
 
The governing law of the present Agreement will be the Law of the State of New
York without regard to conflict of law principles, and any court proceeding
initiated by one party against the other with respect to any dispute under this
Agreement shall be commenced in the United States District Court for the
Southern District of New York, and such court shall have exclusive jurisdiction
over all legal matters and proceedings thereunder.

 
Article 20.    Taxes and Withholding
 
20.01
 
All taxes, assessments, fees and charges, if any, levied on SUPPLIER under
income tax laws or regulations, which are required to be withheld on payments
due to SUPPLIER from Wyeth, hereunder, shall be for the account of SUPPLIER and
will be deducted by Wyeth from such payments due to SUPPLIER. Receipts for all
such taxes, assessments, fees and charges advanced by Wyeth to the taxing
authorities and received by Wyeth shall be sent to SUPPLIER.

 
Article 21.    Force Majeure
 
21.01
 
Any delay in the performance of any of the duties or obligations of any party
(except the payment of money due hereunder) shall not be considered a breach of
this Agreement, and the time required for performance shall be extended for a
period equal to the period of such delay; provided that such delay has been
caused by or is the result of any acts of God, acts of the public enemy,
insurrections, riots, embargoes, labor disputes, including strikes, lockouts,
job actions, or boycotts, fires explosions, floods, shortages of material or
energy or other unforeseeable causes beyond the reasonable control and without
the fault or negligence of the party so affected. The party so affected shall
give prompt notice to the other party of such cause, and shall take commercially
reasonable

 

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steps to relieve the effect of such cause as rapidly as reasonably possible.
Notwithstanding the forgoing, (i) if SUPPLIER or MANUFACTURER is unable to
perform due to the above-enumerated reasons for a period longer than twelve (12)
months, Wyeth shall have a right to terminate this Agreement by providing
written notice to SUPPLIER and MANUFACTURER; and (ii) if Wyeth is unable to
perform due to the above-enumerated reasons for a period longer than twelve (12)
months, SUPPLIER and MANUFACTURER shall each have the right to terminate this
Agreement by providing written notice to Wyeth and each other.

 
Article 22.    Severability
 
22.01
 
In the event that any provision of this Agreement is judicially determined to be
void or unenforceable, in whole or in part, such provision shall be construed to
be separable from the other provisions of this Agreement, which shall retain
full force and effect, and such provision shall be deemed to be amended in the
manner and to the extent necessary so that, as so revised, such provision shall
be valid and enforceable.

 
Article 23.    Headings
 
23.01
 
All titles and captions in this Agreement are for convenience purposes only and
shall not be of any force or substance.

 
Article 24.    Use of Names
 
24.01
 
Except as expressly required pursuant to the Act or other governmental rule or
regulation, and except as reasonably determined by Wyeth to be necessary or
appropriate with respect to Finished Dosage containing PRODUCT offered for sale
or sold by Wyeth, no party will without the prior written consent of the other
applicable party: (a) use in advertising, publicity, promotional premiums or
otherwise, any trade name, trademark, trade device, service mark, symbol, or any
abbreviation, contraction or simulation, thereof, owned by such other party; or
(b) represent, either directly or indirectly, that any product or service of any
party is a product or service of any other party.

 

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Article 25.    Independent Contractor
 
25.01
 
Each party is acting under this Agreement as an independent contractor and not
as the agent or employee of any other party. Each party understands and agrees
that it has no authority to assume any obligation on behalf of any other party
and that it shall not hold out to third parties that it has any authority to act
on any other party’s behalf except as expressly permitted herein. Unless
otherwise expressly stated herein, each party shall be responsible for its own
expenses relating to its performance under this Agreement and shall not incur
expenses for any other party’s account, unless expressly authorized herein or by
subsequent written agreements.

 
Article 26.    Waiver
 
26.01
 
No waiver or modification, amendment or release of any of the terms of this
Agreement shall be valid, unless in writing and signed by an authorized
representative of each of the parties hereto. Failure by any party to enforce
any rights under this Agreement shall not be construed as a waiver of such
rights nor shall a waiver by any party in one or more instances be construed as
constituting a continuing waiver or as a waiver in other instances.

 
Article 27.    Public Disclosure
 
27.01
 
No party shall disclose to any third party or originate any publicity, news
release or public announcement, written or oral, whether to the public or the
press, or otherwise, referring to the terms of this Agreement, including its
existence, the subject matter to which it relates, the performance under it or
any of its specific terms and conditions, except (i) for disclosures required by
applicable law, rule, regulation (including but not limited to the rules and
regulations of (1) the Securities and Exchange Commission and (2) the Comision
Nacional del Mercado de Valores, Spanish Stock Exchange Authority) or judicial
or administrative process, or (ii) by such announcements as are mutually agreed
upon by the parties in writing, or (iii) by such disclosures to a third party
made

 

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pursuant to a bona fide, duly executed and delivered confidentiality agreement
entered into with such third party (1) for the benefit of all parties hereto,
(2) pertaining to a possible assignment of this Agreement or of rights and
benefits hereunder to such third party by one or more of the parties hereto, and
(3) pursuant to which such third party agrees to perform and observe all of the
provisions of this Agreement pertaining to confidentiality and disclosure
including, without limitation, those contained in Article 11 and this Article
27, as though such third party were a party hereto.

 
Article 28.    Notices
 
28.01
 
Unless otherwise specified herein, all notices required or permitted to be given
under this Agreement shall be in writing and shall be delivered either
personally or by facsimile. A copy of each notice so given shall also be sent by
registered or certified mail, return receipt requested, or by courier service
which confirms in writing to the sender delivery thereof to the addressee. All
notices shall be so delivered or sent to the receiving party at such party’s
address set forth below, or at such other address as may from time-to-time be
furnished by similar notice by either party. Any notice, a copy of which shall
be sent by registered or certified mail or courier service as aforesaid, shall
be deemed to have been given when such copy shall have been so mailed or sent.

 

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If to SUPPLIER:
 
SeraCare Life Sciences, Inc.
1935 Avenida del Oro, Suite F
Oceanside, California 92056
U.S.A.
Facsimile No. (760) 806-8933
Attention: President
 
If to MANUFACTURER:
 
General Manager
Instituto Grifols, S.A.
Pol. De Levante
C/Can Guash,
Parets del Valles (Barcelona) Spain
Facsimile No. 34-93-571 0381
       
 
If to Wyeth:
 
Vice President
 
And
 
Vice President
Global BioPharmaceutical
     
Global Materials Management
Manufacturing Wyeth
     
Wyeth-Ayerst Laboratories
One Burtt Road
     
2100 Renaissance Boulevard
Andover, MA 01810
     
King of Prussia, PA 19406
U.S.A.
     
U.S.A.
Facsimile No. (978) 247-2600
     
Facsimile No. (610) 313-4687

 
  
 
or to such other address as the addressee shall have last furnished, in writing,
to the addresser.

 
Article 29.    ACKNOWLEDGEMENT
 
29.01
 
The parties to this agreement acknowledge by their signature below that they are
aware that the MANUFACTURER’s product Albumin (Human) *** which is registered by
the FDA, health authorities in the European Union and other health authorities
in the International market is not the same as the PRODUCT produced under this
Agreement. The PRODUCT supplied under this Agreement is MANUFACTURER’s Albumin
(Human) *** modified for and behalf of Wyeth following specifications provided
by Wyeth and as such differs from MANUFACTURER’s registered Albumin. Further,
the parties acknowledge that

 

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the PRODUCT will not be mixed by Wyeth with any other product formulation that
contains any other product or ingredient of human origin, including but not
limited to any albumin manufactured by any person or entity other than
MANUFACTURER. The foregoing sentence shall not limit Wyeth’s ability to purchase
(subject to Section 3.02(b)) and use albumin from other sources so long as such
albumin is not mixed with the PRODUCT.

 
  
 
Wyeth acknowledges that, except as the context otherwise requires, all
references to FDA authorizations, or any other Governmental bodies’ permits
refer to MANUFACTURER’s Albumin (Human) ***, and in no case to the PRODUCT as
defined in the present Agreement, except as the context otherwise requires.
Wyeth will hold MANUFACTURER and SUPPLIER harmless of any claim whatsoever that
may arise in connection with any kind of authorization referred to the PRODUCT.

 
  
 
The parties further acknowledge and agree that (a) PRODUCT may be manufactured
and sold by MANUFACTURER and SUPPLIER solely and exclusively to Wyeth and to no
other person or entity whatsoever, and (b) neither MANUFACTURER or SUPPLIER, by
this Agreement or otherwise, shall have or acquire, except as expressly provided
herein for purposes hereof, any right, title or interest in or to PRODUCT or the
Specifications, Release Criteria, Product IP or other intellectual property or
rights of or pertaining to PRODUCT.

 
Article 30.    Entire Agreement
 
30.01
 
This Agreement, including the Confidentiality Agreement incorporated herein by
reference, constitutes the entire agreement between the parties concerning the
supply of PRODUCT to Wyeth, and supersedes all written or oral agreements or
understandings with respect thereto.

 
  
 
[The remainder of this page has purposely been left blank. The signature page
follows.]

 

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HSA Supply Agreement
 
Page 46

 
***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

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WYETH BIOPHARMA.
 

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives.
 
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
 
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
                    Wyeth Pharmaceuticals, Inc.
 
                    SeraCare Life Sciences Inc.
By:
  
/s/    H. Michael Koplove        

--------------------------------------------------------------------------------

(Signature)
 
By:
  
/s/    Michael Crowley Jr        

--------------------------------------------------------------------------------

(Signature)
Name:
  
H. Michael Koplove Ph.D.

--------------------------------------------------------------------------------

(Print/type)
 
Name:
  
Michael Crowley Jr

--------------------------------------------------------------------------------

(Print/type)
Title:
  
Vice President - Manufacturing

--------------------------------------------------------------------------------

 
Title:
  
CEO / President

--------------------------------------------------------------------------------

Date:
  
26 September 2002

--------------------------------------------------------------------------------

 
Date:
  
October 4th 2002

--------------------------------------------------------------------------------

 
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
        
                          Instituto Grifols, S.A.
        
By:
  
/s/    Javier Jorba        

--------------------------------------------------------------------------------

(Signature)
        
Name:
  
Javier Jorba

--------------------------------------------------------------------------------

(Print/type)
        
Title:
  
CEO

--------------------------------------------------------------------------------

        
Date:
  
14 October 2002

--------------------------------------------------------------------------------

        

 

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HSA Supply Agreement
 
Page 47

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WYETH BIOPHARMA.
 

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APPENDIX A
 
Confidentiality Agreement
 
(Attached hard copy)

 

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HSA Supply Agreement
 
Page 1

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GENETICS INSTITUTE, INC.
CONFIDENTIAL DISCLOSURE AGREEMENT
 
THIS CONFIDENTIAL DISCLOSURE AGREEMENT (the “Agreement”) is made as of this 19
day of November, 1998 (the “Effective Date”) by and between Genetics Institute,
Inc., a Delaware corporation with a business address at 87 CambridgePark Drive,
Cambridge, Massachusetts 02140 (“GI”) and the company named on the signature
page (“Company”).
 
1.
 
Background.    GI and Company intend to engage in communications/activities for
the purpose summarized in Exhibit A. In the course of these communications and
activities, GI and Company may disclose or deliver to each other certain
Confidential Information (defined below). GI and Company have entered into this
Agreement in order to ensure the confidentiality of the Confidential
Information.

 
2.
 
Definitions.

 

 
2.1.
 
“Confidential Information” means any scientific, technical, trade or business
information possessed, obtained by, developed for or given to the disclosing
party which is treated by the disclosing party as confidential or proprietary
including, without limitation, Research Materials (defined below), formulations,
techniques, methodology, assay systems, formulae, procedures, tests, equipment,
data, reports, know-how, sources of supply, patent positioning, relationships
with consultants and employees, business plans and business developments,
information concerning the existence, scope or activities of any research,
development, manufacturing, marketing or other projects of the disclosing party,
and any other confidential information about or belonging to the disclosing
party’s suppliers, licensors, licensees, partners, affiliates, customers,
potential customers or others.

 

 
  
 
“Confidential Information” does not include information which (a) was known to
the receiving party at the time it was disclosed, other than by previous
disclosure by the disclosing party, as evidenced by the receiving party’s
written records at the time of disclosure; (b) is at the time of disclosure or
later becomes publicly known under circumstances involving no breach of this
Agreement; (c) is lawfully and in good faith made available to the receiving
party by a third party who did not derive it, directly or indirectly, from the
disclosing party; or (d) is independently developed by a receiving party without
the use of the disclosing party’s Confidential Information.

 

 
2.2.
 
Examples of Confidential Information.    For purposes of illustration, the
Confidential Information may be contained in various media, including, without
limitation, records of research data and observations, records and results of
preclinical and clinical trials, patent applications, regulatory filings,
computer programs, manuals, plans, drawings, designs, specifications, supply and
customer lists, internal financial data and other documents and records of the
disclosing party, whether or not labeled or identified as “Confidential.”

 

 
2.3.
 
“Research Materials” include, without limitation, genes, DNA sequences,
plasmids, vectors, expression systems, cells, cell lines, organisms, antibodies,
biological substances, and any constituents, progeny, mutants, derivatives or
replications thereof or therefrom, together with all reagents, chemical
compounds or other materials.

 
3.
 
Confidentiality.

 

 
3.1.
 
Acknowledgment Regarding Ownership.    GI and Company each acknowledge that the
other is and shall at all times remain the sole owner of its Confidential
Information.

 

 
3.2.
 
Nondisclosure of Confidential Information.    GI and Company shall not directly
or indirectly publish, disseminate or otherwise disclose, deliver or make
available to any person outside its organization any of the other party’s
Confidential Information. GI and Company may disclose the other party’s
Confidential Information to persons within their respective organizations and to
their respective affiliates and partners who/which have a need to receive such
Confidential Information in order to further the purposes of this Agreement and
who/which are bound to protect the confidentiality of such Confidential
Information, as set forth in Section 3.5 below. GI and Company may disclose the
other party’s Confidential Information to a governmental authority or by order
of a court of competent jurisdiction, provided that such disclosure is subject
to all applicable governmental or

 
- CONFIDENTIAL -

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Page 2 of 3
 

 
  
 
judicial protection available for like material and reasonable advance notice is
given to the other party.

 

 
3.3.
 
Use of Confidential Information.    GI and Company shall use the other party’s
Confidential Information solely for the purpose(s) set forth in Exhibit A or for
such other purposes as may be agreed upon by the parties in writing.

 

 
3.4.
 
Physical Protection of Confidential Information.    GI and Company shall
exercise all commercially reasonable precautions to physically protect the
integrity and confidentiality of the other party’s Confidential Information.

 

 
3.5.
 
Agreements with Personnel, Affiliates and Partners.    GI and Company have or
shall obtain agreements with all parties who are permitted access to the other
party’s Confidential Information under this Agreement which impose comparable
confidentiality obligations on such parties.

 
4.
 
Expiration; Termination.

 

 
4.1.
 
Expiration; Return of Research Materials.    This Agreement will expire five (5)
years from the last date of disclosure of any Confidential Information. Upon
expiration, or sooner upon the disclosing party’s request, the receiving party
shall promptly return to the disclosing party all Research Materials. Upon
expiration, the receiving party shall be free to use any other Confidential
Information received under this Agreement without restriction or obligation,
except as governed by patent law and/or other agreements between the parties.

 

 
4.2.
 
Termination for Breach.    Prior to expiration, however, either party may
terminate this Agreement immediately upon written notice to the other party if
it determines that the other party has breached its confidentiality obligations.
In this event, the party in breach shall promptly return to the other all
Confidential Information and it’s confidentiality obligations will continue
indefinitely.

 
5.
 
Miscellaneous.

 

 
5.1.
 
Entire Agreement.    This Agreement constitutes the entire agreement of the
parties with regard to its subject matter, and supersedes all previous written
or oral representations, agreements and understandings between GI and Company.

 

 
5.2.
 
No Modification.    This Agreement may be changed only by a writing signed by
both parties.

 

 
5.3.
 
Severability.    In the event that any one or more of the provisions contained
in this Agreement shall, for any reason, be held to be invalid, illegal or
unenforceable in any respect, such invalidity, illegality or unenforceability
shall not affect any other provisions of this Agreement, and all other
provisions shall remain in full force and effect. If any provision of this
Agreement is held to be excessively broad, it shall be reformed and construed by
limiting and reducing it so as to be enforceable to the maximum extent permitted
by law.

 

 
5.4.
 
Applicable Law.    This Agreement shall in all events and for all purposes be
governed by, and construed in accordance with, the law of The Commonwealth of
Massachusetts.

 
IN WITNESS WHEREOF, duly-authorized representatives of GI and Company have
signed this Agreement as a document under seal as of the Effective Date.
 
GENETICS INSTITUTE, INC.
 
By
 
/s/    Stephen Meyler        

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Print Name
 
Stephen Meyler

--------------------------------------------------------------------------------

Title
 
Purchasing Manager of Systems & Operations

--------------------------------------------------------------------------------

   
duly authorized
COMPANY
       
SeraCare, Inc.

--------------------------------------------------------------------------------

By
 
/s/    Mike Crowley, Jr.        

--------------------------------------------------------------------------------

Print Name
 
Mike Crowley, Jr.

--------------------------------------------------------------------------------

Title
 
Vice President Operations

--------------------------------------------------------------------------------

   
duly authorized
Address
 
1935 Avenida del Oro, Suite F

--------------------------------------------------------------------------------

   
Oceanside, CA 92056

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- CONFIDENTIAL -

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Page 3 of 3
 
Exhibit A
 
Summary of Subject and Purposes of Communications
 
GI will disclose to Company information including manufacturing processes and
product information. Company will discuss manufacturing processes, and
alternative sources of HSA.
 
- CONFIDENTIAL -

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WYETH BIOPHARMA.
 

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APPENDIX B
 
Release Criteria
(including Specifications)
 
(draft attached)

 

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HSA Supply Agreement
 
Page 1

 
***
 
***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

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WYETH BIOPHARMA.
 

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APPENDIX C
 
Technical Agreement
 
(draft attached)

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HSA Supply Agreement
 
Page 1

 
***
 
***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

--------------------------------------------------------------------------------

WYETH BIOPHARMA.
 

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APPENDIX D
 
Product Pricing
 
The pricing for the PRODUCT is set at *** per *** bottle.

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HSA Supply Agreement
 
Page 1

 
***  Confidential Information omitted and filed separately with the Securities
and Exchange Commission.

--------------------------------------------------------------------------------

WYETH BIOPHARMA.
 

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APPENDIX E
 
Form of Purchase Order
 
[Attached Hereto]

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HSA Supply Agreement
 
Page 1

 
This Appendix E has been omitted and shall be furnished supplementally to the
Commission upon request.