Exhibit 10.35


 


*** TEXT OMITTED
AND SUBMITTED SEPARATELY

PURSUANT TO CONFIDENTIAL TREATMENT REQUEST

UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406


 


TOLL
MANUFACTURING AGREEMENT FOR TESTING AND PACKAGING


 


This Agreement is made as of this 4th day of April, 2008
(“Effective Date”), by and between
Talecris Biotherapeutics GmbH, a German company with a place of business at
Lyoner Strasse 15, D-60528 Frankfurt am Main, Niederrad, Deutschland (“Client”) and Catalent France Limoges SAS (“Catalent” collectively, with Client, the “Parties,” and each individually, a “Party”).


 


RECITALS


 


A.                                   Catalent provides packaging and related services to the
pharmaceutical industry; and


 


B.                                     Client is a wholly owned subsidiary of Talecris
Biotherapeutics, Inc. and is the marketing authorization holder for the
products Gamunex®, Prolastin® and Plasbumin® and holds the Import Authorization
according to § 72 AMG (Arzneimittelgesetz = German Drug Law) and holds the
Manufacturing Authorization for Release to the Market according to § 13 AMG; and


 


C.                                     Client desires to engage Catalent to provide certain services
to Client in connection with the packaging and testing of Client’s Final
Container Product (as defined below) and Catalent desires to provide such
services pursuant to the terms and conditions set forth in this Agreement.


 


THEREFORE, in consideration of the mutual covenants, terms and
conditions set forth below, the Parties agree as follows:


 


ARTICLE I


DEFINITIONS


 


The following terms have the following meanings in this
Agreement:


 


1.1                                 “Affiliate(s)”
means, with respect to Client or any third party, any corporation, firm, partnership
or other entity that controls, is controlled by or is under common control with
such entity; and with respect to Catalent, any corporation, firm, partnership
or other entity controlled by PTS Holdings Corp. For purposes of this
definition, “control” shall mean the ownership of at least 50% of the voting
share capital of entity or any other comparable equity or ownership interest.


 


1,2                                 “Applicable Laws”
means all laws, ordinances, rules and regulations within the Territory
applicable to the Testing and Packaging Services of the Final Container Product
or any aspect thereof and the obligations of Catalent or Client, as the context
requires under this Agreement, including, without limitation, (A) all
applicable federal, state and local laws and regulations of each Tenitory; and (B) the
current EU Good Manufacturing Practices for Medicinal Products for Human Use (“eGMPs”) promulgated by the Regulatory Authorities, as
amended from time to time, as applicable to the Testing and Packaging Services.


 


1.3                                 “Certificate of Analysis”
means a certificate in form and substance satisfactory to Client, signed by
Catalent, and authenticating the pharmaceutical analysis in accordance with the
cGMP requirements of each batch of Finished Product delivered to Client. The
relevant Certificate shall contain the sentence: “This batch complies with
specifications and is manufactured in accordance with EEC-GMP and the
requirements laid down in the product license.”


 


1.4                                 “Certificate of Packaging
Compliance” means a certificate in form and substance satisfactory
to Client, signed by Catalent, and authenticating the proper packaging of each
batch of the Finished Product delivered to Client. The relevant Certificate
shall contain the following sentence: “This batch complies


 

















 


with specifications and is manufactured in accordance with
EEC-GMP and the requirements laid down in the product license.”


 


1.5                                 “Commencement Date”
means the date upon which Catalent has fulfilled both (i) regulatory
approval of Catalent’s Manufacturing License of Blood and Biological Products
and (ii) completion of validations needed to perform Packaging Services
and Testing. The Commencement Date signifies the ending of the Transfer Period
and the beginning of the Operation Period of this Agreement between Catalent
and Client.


 


1.6                                 “Confidential Information”
has the meaning set forth in Section 9.2.


 


1.7                                 “Contract Year”
means the period commencing on January 1st of each year during the Term
and ending on December 31st of each year; provided, however, that the “Initial Contract Year” shall begin upon the Commencement
Date and end on December 3lst of the same calendar year.


 


1.8                                 “Delivery Date(s)”
means the date(s) set forth in the relevant Purchase Order on which
Catalent must supply Client with Finished Product, as determined pursuant to Section 4.3.


 


1.9                                 “Distributor”
means Arvato, Client’s single point distributor located at Gottlieb-Daimler-Str.
1, 33428 Harsewinkel, Germany.


 


1.10                           “Facility” means
Catalent’s facility at Rue de Dion Bouton, Z.I.Nord, BP 1547, 87021 Limoges
cedex 9, France, or such other facilities as agreed upon by the Parties.


 


1.11                           “Final Release”
means provision by Qualified Person of a document stating that the Finished
Product fulfills the requirement of Article 51 of EC Directive 2001/83/EC.


 


1.12                           “Final Container Product”
means Product which has completed all processing stages including the filling
in primary containers (unlabelled vials) but not including the secondary and
tertiary packaging which shall be performed by Catalent.


 


1.13                           “Finished Product”
means Product which has undergone all stages of production including secondary
and tertiary packaging in its final container but prior to the Client or
designated Qualified Person has performed the Final Release.


 


1.14                           “Operation Period”
means the phase of this Agreement when Catalent is capable of providing Testing
and Packaging Services of the Final Container Products.


 


1.15                           “Package(d) Services
or Packaging Services” means secondary and tertiary packaging (including
diluent and labeling) of the Final Container Products pursuant to the
Specifications and in compliance with Applicable Laws, it being specified that
Client shall be responsible for primary packaging (i.e., bottle and closure
with Product).


 


1.16                           “Product(s)”
means the products of Client which are listed and described in more detail in
the Exhibit A.


 


1.17                           “Product Released to the
Market” means Final Container Product as labeled and contained in
the Packaging and after the Client or designated Qualified Person has performed
the Final Release.


 


2

















 


1.18                           “Purchase Order”
means a written document issued by Client to Catalent in accordance with Article 4
hereof, authorizing Catalent’s performance of Testing and Packaging Services
and other related services pursuant to the terms of this Agreement.


 


1.19                           “Qualified Person”
means the person referred to in Article 48 of Directive 2001/83/EC.


 


1.20                           “Quality Agreement”
means the quality agreement between the Parties for ongoing
operations/manufacturing, to be executed prior to the initiation of Testing and
Packaging Services and incorporated herein by reference.


 


1.21                           “Reasonable Efforts”
means the efforts, consistent with the practice of comparable contract
manufacturing companies with respect to pharmaceutical products of comparable
market potential, that a reasonable person in the position of Catalent would
use so as to achieve a given goal as expeditiously as possible.


 


1.22                           “Regulatory Authority”
means any governmental regulatory authority within a Territory involved in
regulating any aspect of the development, manufacture, market approval, sale, distribution,
packaging or use of the Finished Product.


 


1.23                           “Specifications”
means the specifications for the Testing and Packaging Services set forth in Exhibit B attached to and incorporated in this
Agreement, which shall become a part of this Agreement. The Specifications may
be amended or modified only upon the written agreement of both Parties. These Specifications
are the description in detail of the requirements with which the Finished
Product has to conform — as related to Testing and Packaging Services provided
by Catalent.


 


1.24                           “Technical Agreement”
means the technical agreement between the Parties for ongoing
operations/manufacturing, to be executed prior to the initiation of Testing and
Packaging Services and incorporated herein by reference.


 


1.25                           “Territory”
means those countries listed in Exhibit C.


 


1.26                           “Testing” means
the carrying out of the tests relevant for the adherence to the Specifications
and defined in the marketing authorizations for the Finished Product.


 


1.27                           “Transfer Agreement”
means the combined technical and quality agreement between the Parties for
activities that must occur during the transfer process, to be executed
contemporaneously with this Agreement and incorporated herein by reference.


 


1.28                           “Transfer Period”
means the phase of this Agreement devoted to the transfer of the
product-related necessary know-how from Client to Catalent. This Transfer
Period shall be governed by the terms and conditions of the Transfer Agreement.


 


ARTICLE 2


SCOPE


 


Catalent agrees to perform Testing and Packaging Services on
Final Container Product at the Facility pursuant to the Transfer Agreement, Quality
Agreement and Technical Agreement.


 


The Parties acknowledge that Catalent shall act as Client’s
exclusive EU manufacturer for all of Client’s European Testing and Packaging
Services.


 


3

















 


ARTICLE 3


PRICING AND
PAYMENT TERMS


 


3.1                                 Price. The fees
to be paid to Catalent for the Testing and Packaging Services of the Final Container
Product shall be as set forth in Exhibit D
attached to and incorporated herein by reference (“Price”).


 


Catalent shall issue separate invoices to Client for
Milestone Payments, Packaging Services, Testing, monthly fixed costs and
extraordinary items as specified. Extraordinary items shall be explicitly
ordered by the Client.


 


The Price shall not include the costs of raw materials and
packaging components purchased by Catalent pursuant to Section 5.3, which
cost shall be passed through to Client with agreed upon mark-up as defined in Exhibit D.


 


Any other services performed by Catalent shall be charged on
an hourly basis as defined in Exhibit D.


 


3.2                                 Price Adjustment.


 


(i)                                     Annual Adjustment


 


The Price shall be subject to adjustment once per Contract
Year (“Price Adjustment”). Any Price
Adjustment [***] may be notified to Client by Catalent. Any Price Adjustment [***]
shall require good faith negotiations between the Parties. The Parties shall
agree to the Price Adjustment by December 1 of the year preceding the
Contract Year in issue, and the Price Adjustment shall become effective on January 1
of the Contract Year in issue.


 


(ii)                                  Adjustment due to Changes


 


In the event that Client changes vial sizes or lot sizes, the
Parties shall negotiate in good faith new pricing to the extent Catalent’s
direct costs have changed.


 


In the event that either changes to the Specifications
requested by Client or changes in the applicable regulations result in an
increase of more than [***] in the direct processing costs to Catalent, as
calculated in accordance with French Generally Accepted Accounting Principles (GAAP)
and evidenced by reasonable supporting documentation, the Parties agree to
negotiate in good faith new pricing which reflects the change in Catalent’s
direct costs. Notwithstanding the foregoing, in the event that changes in the
applicable regulations are not specific to Client’s Product but apply to
Catalent in its capacity of pharmaceutical manufacturer, the additional costs
associated with complying with such regulations changes shall be borne
exclusively by Catalent.


 


3.3                                 Invoice.


 


(i)                                     Catalent shall invoice Client upon completion of Packaging
Services and shipment of Final Product sublots to Distributor including
submission of Certificate of Compliance to Client for labeling of Products, barcoding
of Products and procurement of secondary packaging material accordant to Exhibit D.


 


(ii)                                  Catalent shall invoice Client upon completion of Testing and
submission of Certificate of Analysis to Client for management of test samples
(Final Container Product), shipment of


 






*** CONFIDENTIAL TREATMENT
REQUESTED


 


4

















 


samples to laboratory for outsourced tests, management
of test samples (Finished Product) for German batches, testing at internal
laboratories and testing at external laboratories accordant to Exhibit D.


 


(iii)                               Catalent shall invoice monthly fixed costs for facility usage,
storage and destruction of reference samples accordant to Exhibit D.
The invoice shall be issued not later than at the 25th of the respective
month.


 


(iv)                              Catalent shall invoice extraordinary items as management of
recalls (including keeping Finished Product on hold at Catalent and destruction
of products) in separate invoices on monthly basis accordant to Exhibit D.


 


3.4                                 Payment Terms. Client
shall make full payment in Euro to Catalent, at the address specified on the
invoice, no later than forty-five (45) calendar days from the date of each
invoice. If Client has not made payment in full by the expiration of such
forty-five (45) calendar day period, Catalent may charge a late payment fee on
such unpaid and undisputed amount equal to one percent (1%) per month of such
unpaid amount. However, in no event will the rate charged to Client be higher
than the maximum rate allowable under applicable law. The Parties agree to
cooperate to timely resolve all payment disputes.


 


3.5                                 Milestone Payments.


 


Client shall make five milestone payments (the “Milestone
Payments”) to Catalent to acknowledge certain achievements made prior to the
Initial Contract Year on following basis:


 


	
  (i)

  	
  An
  amount of [***] for analytical transfer (I) shall be invoiced in
  January 2008

  
	
  (ii)

  	
  An
  amount of [***] for analytical transfer (II) shall be invoiced in
  April 2008

  
	
  (iii)

  	
  An
  amount of [***] for packaging transfer shall be invoiced in April 2008

  
	
  (iv)

  	
  An
  amount to be agreed for IT interface set up shall be invoiced in
  May 2008

  
	
  (v)

  	
  An
  amount of [***] for project management shall be invoiced in
  September 2008

  
	
  (vi)

  	
  Travel
  expenses shall be reimbursed to Catalent based on actuals

  



 


Client shall make full payment in Euro to Catalent, at the
address specified on the invoice, no later than thirty (30) calendar days from
the date of each invoice.


 


3.6                                 Shipping and Risk of Loss.
Client shall be responsible for costs of shipping Final Container Product from
a facility designated by Client in the United States to Catalent’s facility via
Frankfurt Airport or Client’s warehouse. Client shall be responsible for
routing of shipments as well as preparation of all necessary import
documentation.


 


Final Container Product shall be deemed at all times to be
the property of Client. Responsibility and risk of loss for the Final Container
Product will transfer from Client to Catalent when the Final Container Product
is removed from the truck onto the Catalent dock in Limoges, France. The Final
Container Product shall be stored, while in Catalent’s custody, in accordance
with the Specifications and Applicable Laws.


 


Shipments of Finished Product will be EXW Catalent’s facility
in Limoges, France (Incoterms 2000). Delivery of Finished Product shall be
deemed to have occurred when the Finished Product is delivered into the custody
of the carrier selected by Client and approved by Client at Catalent’s facility.
Client shall handle all shipping logistics to Distributor. Catalent shall
number each lot with a vendor lot number such that each product lot is
traceable to raw materials and/or components used, as well as product
temperature storage history.


 






*** CONFIDENTIAL TREATMENT
REQUESTED


 


5

















 


Risk of loss as to all Finished Product shipped by Catalent
shall pass to Client upon delivery to the common carrier at Catalent’s facility
in Limoges, France. Catalent shall reasonably assist Client in arranging any
desired insurance (in amounts that Client shall determine) and transportation. All
associated customs, duties, costs, taxes, insurance premiums and other expenses
shall be at Client’s expense.


 


3.7                                 Failure to Take Delivery.
If Client fails to take delivery within five (5) business days of any
scheduled Delivery Date, Client shall be billed at that time for all unshipped
Finished Product, and on the first of each month thereafter for reasonable
administration and storage costs. For each such batch of undelivered Finished
Product, Client agrees that: (A) Client has made a fixed commitment to
purchase such Packaging Services and packaging components, (B) risk of
ownership for such Finished Product shall be borne by Client, (C) such
Finished Product shall be on a bill and hold basis for legitimate business
purposes, and (D) Client shall be responsible for any decrease in market
value of such Finished Product that relates to factors and circumstances
outside of Catalent’s control. Within five (5) business days following a
written request from Catalent, Client shall provide Catalent with a letter
confirming items (A) through (D) of this section for each batch of
undelivered Finished Product. The Finished Product shall be stored, while in
Catalent’s custody, in accordance with the Specifications and Applicable Laws.


 


ARTICLE 4


FORECAST, PURCHASE
AND SUPPLY


 


4.1                                 Purchase and Supply.
During the Term of this Agreement and subject to Section 4.4 of this Article 4,
Client shall purchase and Catalent shall supply such quantities of Finished
Product as shall be set forth on Purchase Orders issued by Client to Catalent
under this Agreement.


 


Each Contract Year during the term of this Agreement, Catalent
shall receive from Client a target range of [***] Final Container Product lots
representing approximately [***] to be packaged (as prorated for partial years
including the Initial Contract Year). Each lot received by Catalent may be
subdivided into one (1) to five (5) sub-lots of Finished Product for
release in the Territory. Catalent shall issue a Certificate of Packaging
Compliance for each sublot of Finished Product.


 


The Final Container Product, the material in process at
Catalent’s facility and the Finished Product shall be solely owned by Client at
all times.


 


4.2                                 Forecasts. Within
sixty (60) business days after the beginning of the Initial Contract Year, and
thereafter on the first business day of each month during the Term of this
Agreement, Client shall provide Catalent with a written, non-binding, twelve (12)
month rolling forecast (commencing with the immediately following month) of the
quantity of Finished Product which Client expects to require from Catalent
during each of the subsequent twelve (12) months (“Forecast”).
The first three (3) months of the Forecast shall be firm and binding upon Client
(“Firm Commitment”), and the following
nine (9) months shall constitute non-binding good faith estimates. This
Forecast shall include (i) the requested Delivery Date for the Firm
Commitment, (ii) the quantity of Finished Products to be delivered and (iii) the
lot number to be applied to such Finished Product.


 


4.3                                 Purchase Order. Client
shall provide Catalent a firm order (“Firm Order”) for
Finished Product at least fifteen (15) business days in advance of the first
day of the month in which Client wishes the Packaging Services to be performed.
Within ten (10) business days of receipt of a Purchase Order, Catalent
shall acknowledge in writing its receipt of a Firm Order and shall ship
Finished Products on the


 






*** CONFIDENTIAL TREATMENT REQUESTED


 


6

















 


date specified in the applicable Firm Orders. Such
acknowledgement shall, as applicable, also confirm the Delivery Date or specify
alternate Delivery Dates. Time is of the essence in the performance of the Testing
and Packaging Services by Catalent and Catalent shall meet all Delivery Dates.


 


4.4                                 Cycle Times. Catalent
shall use Reasonable Efforts to perform Testing and Packaging Services in an
expeditious manner. Testing of Final Container Product at Catalent shall be
initiated no later than 5 business days and completed within 30 business days
after receipt of Final Container Product. Packaging Services shall be initiated
within 20 business days and completed within 25 business days of receipt of
Final Container Product, or as mutually agreed to in the Forecast as set out in
Section 4.2. Samples of Final Container Product should be submitted to the
Authorities for OMCL batch release upon receipt of the application from Client.
Samples of Finished Product shall be submitted to the Authorities for OMCL
batch release for Germany upon receipt of application from Client. Shipment of
samples for OMCL batch release shall be fully described in the Quality
Agreement and Catalent’s Standard Operating Procedures.


 


4.5                                 Orders Greater than Forecast.
Catalent shall use Reasonable Efforts within its existing capacity to supply
the quantity of Finished Product ordered as set forth on the relevant Purchase
Order, regardless of the quantity forecast by Client, subject to the capacity
limitations of Catalent’s packaging equipment and the Facility.


 


4.6                                 Amendment of Purchase Orders.
Catalent shall use Reasonable Efforts to accommodate a request by Client to
amend a Purchase Order to increase or decrease the quantity of Finished Product
to be delivered, provided that Catalent shall accommodate increases or
decreases of quantities up to ten percent (10%) of that stated on the original
Purchase Order. In the event such amendment causes an increase in Catalent’s
cost to perform the Packaging Services, the Price shall be increased to reflect
such increased cost. Catalent shall notify Client in writing of such cost
increase promptly after Catalent’s receipt from Client of the amended Purchase
Order, and the increase in such Prices shall be effective for the first lot of
Finished Product after the implementation date of such amendment.


 


Client may cancel any or all outstanding Firm Orders no later
than 15 business days before the date scheduled for the beginning of the
Packaging Services. Any outstanding order may be postponed by Client on ten (10) business
days notice, and may be postponed on shorter notice in the event of a Force Majeure
Event.


 


4.7                                 Terms of Agreement Govern.
No modification or amendment to this Agreement shall be effected by or result
from the receipt, acceptance, signing or acknowledgement of any Party’s
Purchase Orders, Catalent quotations, invoices, shipping documents or other
business forms containing terms or conditions in addition to or different from
the terms and conditions set forth in this Agreement, and the terms of this
Agreement shall supersede any provision in any Purchase Order, the
Specifications or other document that is in addition to or inconsistent with
the terms of this Agreement.


 


4.8                                 Secondary Source. In the
event that Catalent, for any reason, is unable to fulfill Client’s Purchase
Orders, Client reserves the right to secure the services of a qualified third
party to perform the Testing and Packaging Services that were to be performed
by Catalent under this Agreement (the “Secondary Source”).
Such purchase from the Secondary Source shall be considered as purchase from
Catalent for purposes of any annual volume commitment. Procurement of Testing
and Packaging Services by Client from a Secondary Source shall not relieve
Catalent of any liability arising from a breach of this Agreement.


 


4.9                                 Inventory Management Inspections. Client shall have the right during normal business hours, and
upon at least ten (10) business days written notice to Catalent, to inspect
and audit in a reasonable manner the inventory of Final Container Product, packaging
components, and/or Finished Product.


 


7

















 


4.10                           Repackaging Services.
In the event that Finished Product requires repackaging through no fault of
Catalent but upon Client’s request for reasons including, but not limited to, repackaging
Product for another Territory, Client shall assume the costs of depackaging (carton
and label) at the rate established for other services as defined in Exhibit D, and the standard costs of repackaging the
Final Container Product.


 


ARTICLE 5


MATERIALS


 


5.1                                 Supply of Product. Client
shall supply to Catalent the Final Container Product in quantities sufficient
to meet the requirements set forth in accepted Purchase Orders no later than 3
weeks before the scheduled date for Testing and Packaging Services. In the
event that Client provides Product less than two (2) weeks prior to the
scheduled processing date, Catalent shall use Reasonable Efforts to qualify the
Finished Product to meet the scheduled dates set forth in the applicable
Purchase Orders. Catalent shall use the Final Container Product solely and
exclusively for Testing and Packaging Services under this Agreement.


 


5.2                                 Loss of Final Container Product. Catalent shall minimize the loss of Final Container Product
subject to normal manufacturing losses of up to [***] of all Final Container
Product to be delivered to Catalent calculated on an average annual basis (“Shrinkage
Factor”) for the Initial Contract Year. The Shrinkage Factor shall be reduced
to [***] at the beginning of the second Contract Year. In the event that losses
exceed this percentage, Catalent shall indemnify Client for loss of Final
Container Product as defined in Exhibit E,
to be updated annually.


 


5.3                                 Packaging and Labeling Components. Catalent shall be responsible for procuring, inspecting, processing,
storing and releasing adequate packaging (including diluent and labeling) components
based on Client approved specifications and as necessary to meet the Firm
Commitment. Client may, in its sole discretion, decide to provide any such
packaging components to Catalent. Catalent may only purchase packaging (including
diluent and labeling) materials from a third party vendor which is identified
on a vendor list approved by Client. Once a vendor is selected, any changes in
vendors shall be approved in writing by Client. Any such arrangements with
third party vendors shall be required to be subject to audit and inspection by
Client. Catalent will inspect each delivery of components for quality and
identify problems promptly following receipt and prior to their use in
providing Packaging Services. Client shall have the right to review and approve
all test methods used by Catalent to assess the quality of such components.


 


5.4                                 Reimbursement for Materials.
In the event of (A) a Specification change requested by Client for any
reason, (B) termination or expiration of this Agreement, or (C) obsolescence
of any packaging component, Client shall bear the cost of any unused packaging
components, provided that Catalent purchased such packaging components in
quantities consistent with Client’s most recent Finn Commitment plus three (3) months
of inventory (as defined in Section 5.5).


 


5.5                                 Inventory. Catalent
shall maintain a dedicated inventory of packaging components sufficient to meet
at least three (3) months of Client’s forecasted requirements at no
additional charge to Client. Should Client change the Specifications (as
defined herein) and/or any associated packaging component, and should Catalent
have any related items in stock that were intended to, but cannot as a result
of such change, be used for production of the Finished Product and which have
no other use by Client, or for the benefit of Catalent or another client, then
Client shall reimburse Catalent for its costs associated with the acquisition
and disposition of such items.


 






*** CONFIDENTIAL TREATMENT REQUESTED


 


8

















 


5.6                                 Dedicated Equipment.
The Parties agree and acknowledge that Catalent may purchase certain equipment
and tooling necessary for the processing and testing of Client’s Final
Container Product hereunder (the “Dedicated Equipment”). During the Term of
this Agreement, the Dedicated Equipment shall be used solely and exclusively
for Testing and Packaging Services under this Agreement unless Catalent has
obtained Talecris’ prior written approval.


 


Notwithstanding the foregoing, should Catalent desire to use
Dedicated Equipment in order to provide services to clients other than Client, then
Catalent shall submit a request to Client and the Parties shall negotiate in
good faith as to the terms of such use so as to minimize impact to the Testing
and Packaging Services under this Agreement. The terms may include some form of
compensation to Client.


 


ARTICLE 6


REGULATORY


 


6.1                                 Regulatory Authority Inspection. Catalent hereby agrees to advise Client promptly of any
proposed or unannounced inspection of the Final Container Product(s), Finished
Products or Testing and Packaging Services by any Regulatory Authority as
further described in the Quality Agreement.


 


6.2                                 Client Technical Representative. During the Term of this Agreement, Client and/or Client’s
Affiliate shall have the right to have one or more technical representatives
present in the area of the Facility where the Testing and Packaging Services
are being conducted during performance of the Testing and Packaging Services to
(i) review the testing and packaging process; (ii) review any
relevant records in connection with such testing and packaging process and
assess its compliance with cGMPs, the Specifications and Applicable Law; and (iii) discuss
any related issues with Catalent’s management personnel. Client’s technical
representatives, when on-site (including during any inspection conducted
pursuant to Section 6.1), shall comply with Catalent’s rules and
regulations. Client shall indemnify and hold Catalent and its Affiliates
harmless from all liability resulting from the presence of Client’s technical
representatives at the Facility.


 


6.3                                 Audit. Client
and/or Client’s Affiliate shall have the right during normal business hours and
upon at least ten (10) business days written notice to Catalent, to
inspect and audit in a reasonable manner those portions of the Facility in
which Testing and Packaging Services are conducted in order to ensure Catalent’s
compliance with its obligations under this Agreement as outlined in the
Transfer, Technical and Quality Agreements.


 


6.4                                 Product Information.
Client, at its expense, shall furnish Catalent with all available health, safety
and environmental information concerning the Final Container Product to be
tested and packaged by Catalent hereunder, including without limitation, material
safety data sheets.


 


6.6                                 Regulatory Compliance.
Client shall be responsible for securing all licenses or permits required by
law or by any Regulatory Authority and comply with all ordinances, laws orders,
rules, and regulations pertaining to the Finished Product. Without limiting the
foregoing, Catalent, at its sole cost, shall be solely responsible for securing
all licenses or permits required by law or by any Regulatory Authority and
comply with all ordinances, laws orders, rules, and regulations which pertain
to the use of the Facility and performance of the Testing and Packaging
Services under this Agreement (provided such regulations apply to Catalent in
its capacity of pharmaceutical product manufacturer and do not pertain to any
specific Product).


 


Catalent shall be responsible to maintain (a) all
permits and licenses required by any Regulatory Authority with respect to the
Facility, (b) all records necessary to comply with Applicable Laws and


 


9

















 


regulations applicable to the packaging of the Final
Container Product, as well as (c) a quality control program consistent
with cGMPs and applicable regulations.


 


Without prior written consent of Client, Catalent shall not
make any changes to the testing and packaging facilities, equipment, processes,
testing procedures, validation procedures, suppliers of packaging components or
documentation systems used to perform the Testing and Packaging Services if
such change would affect any regulatory submission, license, permit, certification
or approval required for the Product or the performance of the Testing and
Packaging Services.


 


Catalent and Client shall enter into the Quality Agreement
containing the policies, procedures and standard by which the Parties shall
coordinate and implement the operational and quality assurance activities as
well as regulatory and compliance objectives contemplated in this Agreement.


 


During the Term of this Agreement, Catalent shall assist
Client with all regulatory matters relating to the Finished Product under this
Agreement, at Client’s request and at Client’s expense. In particular, Catalent
shall use Reasonable Efforts to assist Client in obtaining and maintaining all
approvals and authorizations of any govermnental agencies necessary for the
Final Release to the market, the use or distribution of the Finished Product. Each
Patty intends and commits to cooperate to satisfy all Applicable Laws relating
to Testing and Packaging Services under this Agreement.


 


6.7                                 Recalls and Adverse Events


 


Catalent shall inform Client promptly of any information
relating to the activity, side effects, toxicity and/or safety of the Finished
Product that becomes known to Catalent during the Term of this Agreement. Furthermore,
Catalent shall inform Client promptly of any defects in the packaging processes
for any Product that become known to Catalent during the Term of this
Agreement.


 


Client shall have the right to control any recall, and the
Parties will cooperate in implementing such recall. In the event that any
governmental agency issues a recall or takes a similar action in connection
with the Finished Product, or in the event that either Party determines that an
event, incident or circumstance has occurred which may result in the need for a
recall or market withdrawal, the Party with such information shall, within
twenty-four (24) hours, advise the other Patty of the circumstances. Catalent
shall have adequate systems to quarantine product upon receipt and in the event
of a recall, as further described in the Quality Agreement.


 


ARTICLE 7


TESTING; SAMPLES


 


7.1                                 Sampling and Testing of Final Container Product. Pursuant to the Technical Agreement, Catalent shall be
responsible for all quality control and testing of the Final Container Product,
Finished Products and providing test samples to an Official Medicines Control
Laboratory (OMCL) in order to assure that the Finished Product is in conformity
in all material respects with the Specifications and Applicable Laws, including
without limitation cGMP standards and EU Directives, and any other procedures
and documents subsequently issued and agreed to by the Parties. Catalent shall
issue a Certificate of Analysis for each batch of Finished Product.


 


Client, upon receipt of Finished Product from Catalent, shall
have fifteen (15) business days to inspect such Finished Product. Any Finished
Product that is not rejected by Client within fifteen (15) business days of
receipt from Catalent shall be deemed to have been accepted by Client. Notwithstanding
the foregoing, in the event of latent defects, Client shall notify Catalent of
such defects within five (5) business days of discovery thereof. In the
event Client believes that the Finished Product does not conform in all
material respects to the Specifications, Client shall send to Catalent, via
overnight delivery


 


10














 


service or certified mail, return receipt requested, within
three (3) business days of discovery of the defect, a notice of rejection
along with samples of the rejected Finished Product. Finished Product that
Catalent agrees are defective or non-conforming shall be handled by Catalent in
accordance with Section 7.2.  If Catalent
does not agree with Client’s determination that the Finished Product fail to
meet the Specifications, the rejected Finished Product shall be handled
pursuant to procedures described in the Quality Agreement.


 


Catalent shall keep an adequate quantity of reserve samples
for the time required by Applicable Laws.


 


7.2                                 Nonconforming Finished Product.
In the event that Catalent provides Finished Product that does not conform to
the Specifications, or that has not been packaged, stored or tested in
accordance with the Specifications (“Nonconforming Finished
Product”), Client shall notify Catalent in writing of Client’s
election to either (i) reprocess Nonconforming Finished Product, at Catalent’s
sole expense, so that it meets all required Specifications using Reasonable
Efforts or (ii) require Catalent to refund to Client the cost of goods
contained in the Nonconforming Finished Product as defined in Exhibit E, to be updated annually. Such election shall
be in addition to any other rights and remedies available to Client in law or
in equity.


 


ARTICLE 8


REPRESENTATIONS
AND WARRANTIES


 


8.1                                 Catalent. Catalent
represents and warrants to Client that:


 


A.                                   the Testing and Packaging Services provided hereunder and the
Finished Product delivered to Client shall comply with the Specifications, the
Quality Agreement, Client’s instructions, cGMPs as well as Applicable Laws.


 


B.                                     Catalent shall store and handle the Final Container Product
and Finished Product in accordance with Applicable Laws and the Specifications.


 


C.                                     Catalent shall comply with the terms and conditions of this
Agreement in performing the Packaging Services and delivering the Finished
Product.


 


D.                                    Catalent represents and warrants that it is not subject to
and will not enter into any arrangements which may preclude compliance with the
provisions of this Agreement.


 


E.                                      Catalent represents and warrants that neither Catalent nor
any of its officers, directors, agents, Affiliates or employees rendering
Testing and Packaging Services has been convicted of a crime for which a person
or entity can be debarred. Catalent shall immediately notify Client upon any
inquiry or the commencement of any such investigation or proceeding.


 


F.                                      To Catalent’s knowledge, the work to be performed by Catalent
under this Agreement shall not violate or infringe upon any trademark, tradename,
copyright, patent or other rights held by any person or entity.


 


G.                                     It has obtained all permits, licenses or authorizations from any
applicable Regulatory Authority necessary or required for the use of the
Facility and the performance of its Testing and Packaging Services hereunder.


 


8.2                                 Client. Client
represents and warrants to Catalent that:


 


11

















 


A.                                   The Product and any other materials supplied by Client shall
comply with all applicable Specifications and shall have been produced in
compliance with Applicable Laws and the artwork supplied by Client shall comply
with Applicable Laws;


 


B.                                     It has (or shall have, prior to Catalent’s delivery of
Finished Product to Client) obtained all permits, licenses or authorizations
from any applicable Regulatory Authority necessary or required for the sale, marketing
or entering into commerce of any Finished Product;


 


C.                                     To Client’s knowledge, it has all necessary authority and
right, title and interest in and to any patents, inventions and developments
related to the Finished Product and the manufacturing and packaging of the
Final Container Product, and Client hereby grants to Catalent a non-exclusive, royalty-free,
worldwide license to use any and all of such right, title and interest as may
be necessary for Catalent to perform its obligations under this Agreement;


 


D.                                    Subject to Section 8.1(F), to Client’s knowledge, the
work to be performed by Catalent under this Agreement shall not violate or
infringe upon any trademark, tradename, copyright, patent or other rights held
by any person or entity.


 


E.                                      It has provided all safe handling instructions, health and
environmental information and material safety data sheets applicable to the
Final Container Product or to any other materials supplied by Client, except as
disclosed to Catalent in writing by Client in sufficient time for review and
training by Catalent prior to delivery;


 


F.                                      All Finished Product delivered to Client by Catalent shall be
held, used and/or disposed of by Client in accordance with all Applicable Laws;


 


G.                                     Client shall comply with all Applicable Laws applicable to
Client’s performance under this Agreement and its use of any materials or
Finished Product provided by Catalent under this Agreement; and


 


H.                                    Unless otherwise agreed by the Parties in writing, Client has
(1) provided data known to Client regarding the packaging and Client’s
requirements for the packaging, (2) provided Catalent with information
known to Client and which Client believes is necessary to develop the scope of
work, and estimated or fixed costs for the packaging, (3) reviewed and
approved all Specifications, and (4) if applicable, prepared all
submissions to Regulatory Authorities.


 


8.3                                 Mutual. Each
Party hereby represents and warrants to the other Party that:


 


A.                                   Existence and Power.
Such Party (1) is duly organized, validly existing and in good standing
under the laws of the state in which it is organized, (2) has the power
and authority and the legal right to own and operate its property and assets, and
to carry on its business as it is now being conducted, and (3) is in
compliance with all requirements of Applicable Laws, except to the extent that
any noncompliance would not materially adversely affect such Party’s ability to
perform its obligations under the Agreement;


 


B.                                     Authorization and Enforcement of Obligations. Such Paity (1) has the power and authority and the legal
right to enter into this Agreement and to perform its obligations hereunder and
(2) has taken all necessary action on its part to authorize the execution
and delivery of this Agreement and the performance of its obligations
hereunder.


 


12

















 


C.                                     Execution and Delivery.
This Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms;


 


D.                                    No Consents. All
necessary consents, approvals and authorizations of all Regulatory Authorities
and other persons required to be obtained by such Party in connection with the
Agreement will be obtained prior to initiation of Testing and Packaging
Services; and


 


E.                                      No Conflict. The
execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (1) do not conflict with or violate any requirement
of Applicable Laws; and (2) do not materially conflict with, or constitute
a material default or require any consent under, any contractual obligation of
such Party.


 


8.4                                 Limitations. THE
REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE AND
EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND
NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY
KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.


 


ARTICLE 9


CONFIDENTIALITY
AND NON-USE


 


9.1                                 Mutual Obligation. Catalent
and Client agree that they shall not use the other Party’s Confidential
Information (defined below) except as necessary for the receiving Party to
perform its obligations under this Agreement or disclose the other Party’s
Confidential Information to any third Party without the prior written consent
of the other Party except as required by law, regulation or court or
administrative order; provided, however, that prior to making any such legally
required disclosure, the Party making such disclosure shall give the other
Party as much prior notice of the requirement for and contents of such
disclosure as is practicable under the circumstances. Notwithstanding the
foregoing, each Party may disclose the other Party’s Confidential Information
to any of its Affiliates that (A) need to know such Confidential
Information for the purpose of performing under this Agreement, (B) are
advised of the contents of this Article, and (C) agree to be bound by the
terms of this Article.


 


9.2                                 Definition. As used
in this Agreement, the term “Confidential Information”
includes all such information furnished by Catalent or Client, or any of their
respective representatives or Affiliates, to the other or its representatives
or Affiliates, whether furnished before, on or after the date of this Agreement
and furnished in any form, including but not limited to written, verbal, visual,
electronic or in any other media or manner. Confidential Information includes
all proprietary technologies, know-how, trade secrets, discoveries, inventions
and any other intellectual property (whether or not patented), analyses, compilations,
business or technical information and other materials prepared by either Party,
or any of their respective representatives, containing or based in whole or in
part on any such information furnished by the other Party or its
representatives. Confidential Information also includes the terms of this
Agreement.


 


9.3                                 Exclusions. Notwithstanding
Section 9.2, Confidential Information does not include information that (A) is
or becomes generally available to the public or within the industry to which
such information relates other than as a result of a breach of this Agreement, or
(B) is already known by the receiving Party at the time of disclosure as
evidenced by the receiving Party’s written records, or (C) becomes
available to the receiving Party on a non-confidential basis from a source that
is entitled to disclose it on a non-


 


13

















 


confidential basis, or (D) was or is independently
developed by or for the receiving Party without reference to the Confidential
Information, as evidenced by the receiving Party’s written records.


 


9.4                                 No Implied License. The
receiving Party shall obtain no right of any kind or license under any patent
application or patent by reason of this Agreement. All Confidential Information
shall remain the sole property of the Party disclosing such information or
data.


 


9.5                                 Return of Confidential Information. Upon termination of this Agreement, the receiving Party
shall, upon request, promptly return within thirty (30) business days all such
information, including any copies thereof, and cease its use or, at the request
of the disclosing Party, shall promptly destroy the same and certify such
destruction to the disclosing Party; except for a single copy thereof, which
may be retained for the sole purpose of determining the scope of the
obligations incurred under this Agreement.


 


9.6                                 Survival. The
obligations of this Article 9 shall terminate five (5) years from the
expiration or termination of this Agreement.


 


9.7                                 Injunctive Relief. Each
Party recognizes that the willingness of the other Party to provide access to
its Confidential Information is in reliance on the assurance by such Party that
it will fully comply with the terms of this Agreement. If, at any time, either
Party shall breach or threaten to breach or violate in any manner any of its
obligations set forth herein, the non-breaching Party shall be entitled to seek
equitable relief by way of injunction in addition to, but not in substitution
for, any and all other relief to which such Party may be entitled at law or in
equity.


 


ARTICLE 10


TERM AND
TERMINATION


 


10.1                           Term. The term
of this Agreement, unless sooner terminated as provided below, shall begin on
the Effective Date and shall continue until the fifth anniversary of the
Commencement Date (“Term”). The
Agreement may be renewed, at Talecris’ sole option two (2) times for two
year extension periods, and thereafter, upon mutual written agreement of the
Parties, for indefinite numbers of two year periods.


 


10.2                           Termination with Prior Notice.
Client may terminate this Agreement upon twelve (12) months advance prior
notice to Catalent and Catalent may terminate said agreement only after
thirty-six (36) months have passed since the Commencement Date and upon
twenty-four (24) months advance notice to Client.


 


10.3                           Immediate Termination.
Either Party shall have the right to immediately terminate this Agreement if (A) the
other Party files a petition in bankruptcy, takes the benefit of any insolvency
act, or enters into an agreement with its creditors, or applies for or consents
to the appointment of a receiver or trustee, or makes an assignment for the
benefit of creditors, or suffers or permits the entry of any order adjudicating
it to be bankrupt or insolvent and such order is not discharged within thirty (30)
business days; or (B) if the other Party materially breaches any of the
provisions of this Agreement, and such breach is not cured within thirty (30) business
days after the giving of written notice.


 


10.4                           Transition; Wind-down.
In the event of early termination, the Parties will cooperate (to the extent
commercially reasonable) in the orderly transition of Testing and Packaging
Services so as not to cause inconvenience to either Party. In the event of
notice of such early termination by Catalent, Catalent shall perform such
functions reasonably necessary or required in connection with the orderly
wind-down of the Testing and Packaging Services as required by the terms of
this Agreement and/or any Applicable Law, and Client shall pay Catalent for the
Testing and Packaging Services performed, under the terms and conditions of
this Agreement.


 


14

















 


10.5                           Effect of Termination.
Expiration or termination of this Agreement shall be without prejudice to any
rights or obligations that accrued to the benefit of either Party prior to such
expiration or termination. In the event of any termination, Catalent shall
promptly return (A) any remaining inventory of materials received from
Client or Client’s suppliers, (B) all packaging components paid for by
Client, (C) all remaining inventories of the Final Container Product; and (D) any
other Product or material being stored for Client, to Client at Client’s
expense. Catalent shall have no obligation to return the foregoing until all
outstanding invoices sent by Catalent to Client have been paid in full. Client
shall also be required to pay, at the applicable Price set forth in the
relevant Purchase Order for completed but not yet shipped Finished Product, Finished
Product in process and Finished Product shipped but not yet invoiced, subject
to Sections 4.6 (Amendment of Purchase Orders) and 15.15 (Force Majeure). In
the event Client breaches or terminates this Agreement or any Purchase Order, (other
than as a result of a breach by Catalent), Client shall also be required to pay
Catalent for its direct cost of all materials purchased by Catalent for
Packaging plus an administrative fee of nine percent (9%) of such amount. Client
shall specify the location in the European Union to which delivery, at Client’s
expense, of the foregoing is to be made. Confidential Information exchanged between
Client and Catalent shall be promptly returned upon termination of the
Agreement.


 


ARTICLE 11


INDEMNIFICATION


 


11.1                           Indemnification by Catalent.
Catalent shall indemnify and hold harmless Client, its Affiliates, and their
respective directors, officers, employees and agents (“Client Indemnitees”)
from and against any and all suits, claims, losses, demands, liabilities, damages,
costs and expenses (including reasonable attorneys’ fees) in connection with
any suit, demand or action by any third party (“Losses”)
arising out of or resulting from (A) any breach of its representations, warranties
or obligations set forth in this Agreement or (B) any negligence or
intentional misconduct by Catalent, except to the extent that any of the
foregoing arises out of or results from any Client Indemnitee’s negligence, intentional
misconduct or breach of this Agreement.


 


11.2                           Indemnification by Client.
Client shall indemnify and hold harmless Catalent, its Affiliates, and their
respective directors, officers, employees and agents (“Catalent
Indemnitees”) from and against all Losses arising out of or
resulting from (A) any breach of its representations, warranties or
obligations set forth in this Agreement; (B) any manufacture, shipping, sale,
promotion, distribution, use of or exposure to the Final Container Product, Finished
Product or any materials supplied by Client, including, without limitation, product
liability or strict liability; (C) Client’s exercise of control over the
Testing and Packaging Services to the extent that Client’s instructions or
directions violate Applicable Law; (D) any actual or alleged infringement
or violation of any patent, trade secret, copyright, trademark or other
proprietary rights related to the Finished Product and the manufacturing and
packaging of the Final Container Product provided by Client or any work to be
performed by Catalent under this Agreement; or (E) any negligence or
intentional misconduct by Client, except to the extent that any of the
foregoing arises out of or results from any Catalent Indemnitee’s negligence, intentional
misconduct or breach of this Agreement.


 


11.3                           Indemnification Procedures.
All indemnification obligations in this Agreement are conditioned upon the
Party seeking indemnification: (A) promptly notifying the indemnifying
Party of any claim or liability of which the Party seeking indemnification
becomes aware (including a copy of any related complaint, summons, notice or
other instrument); provided, however, that failure to provide such notice
within a reasonable period of time shall not relieve the indemnifying Party of
any of its obligations hereunder except to the extent the indemnifying Party is
prejudiced by such failure; (B) cooperating with the indemnifying Party in
the defense of any such claim or liability (at the indemnifying Party’s
expense);


 


15

















 


and (C) not compromising or settling any claim or
liability without prior written consent of the indemnifying Party.


 


ARTICLE 12


LIMITATION OF
LIABILITY


 


12.1                           EXCEPT FOR DAMAGES ARISING FROM CATALENT’S WILLFUL MISCONDUCT,
IN NO EVENT SHALL CATALENT’S TOTAL LIABILITY UNDER THIS AGREEMENT, INCLUDING, WITHOUT
LIMITATION, ANY OF CATALENT’S INDEMNITY OR OTHER FINANCIAL OBLIGATIONS UNDER
THIS AGREEMENT, EXCEED (A) DURING THE FIRST CONTRACT YEAR, EURO FOUR
MILLION AND (B) THEREAFTER, TWO (2) TIMES FEES PAID DURING THE PREVIOUS
CONTRACT YEAR IN WHICH THE CLAIM AROSE, BUT IN NO EVENT MORE THAN EURO SIX
MILLION. NOTWITHSTANDING THE FOREGOING, IN NO EVENT SHALL CTALENT’S LIABILITY
FOR LOSSES TO ACTIVE PHARMACEUTICAL INGREDIENT, BULK DRUG PRODUCT, OR OTHER
CLIENT SUPPLIED MATERIALS, WHETHER OR NOT INCORPORATED INTO FINISHED PRODUCT, EXCEED,
ON A PER LOSS INCIDENT BASIS, EITHER (I) WHERE CLIENT SEEKS REIMBURSEMENT
FOR SUCH LOSSES FROM ITS INSURERS, THE AMOUNT OF ACTUAL CASH DEDUCTIBLE PAID BY
CLIENT TO ITS INSURERS UNDER THE APPLICABLE INSURANCE POLICIES OR (II) WHERE
CLIENT DOES NOT SEEK REIMBURSEMENT FOR SUCH LOSSES FROM ITS INSURERS, CLIENT’S
ACTUAL REPLACEMENT COST FOR SUCH MATERIALS; BUT IN EITHER CASE DESCRIBED IN CLAUSES
(I) AND (II) ABOVE, NOT TO EXCEED EURO EQUIVALENT OF $500,000.


 


NOTHING IN THIS SECTION 12.1 SHALL, TO THE EXTENT
APPLICABLE, LIMIT THE LIABILITY OF CATALENT FOR (A) DEATH OR PERSONAL
INJURY ARISING FROM CATALENT’S OR ANY OF ITS AFFILIATE’S, OR ANY OF THEIR
RESPECTIVE EMPLOYEES’, REPRESENTATIVES’ OR AGENTS’ NEGLIGENCE OR INTENTIONAL
MISCONDUCT; (B) FOR THE FRAUD OF CATALENT, ANY OF ITS AFFILIATES OR ANY OF
THEIR RESPECTIVE EMPLOYEES, REPRESENTATIVES OR AGENTS; OR (C) FOR ANY MATTER
FOR WHICH IT WOULD BE ILLEGAL FOR CATALENT OR ANY OF ITS AFFILIATES TO EXCLUDE
OR TO ATTEMPT TO EXCLUDE LIABILITY.


 


12.2                           EXCEPT FOR DAMAGES ARISING FROM A PARTY’S WILLFUL MISCONDUCT,
IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL
OR CONSEQUENTIAL LOSSES, DAMAGES, COSTS OR EXPENSES OF ANY NATURE WHATSOEVER, INCLUDING
WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS, DATA OR USE, WHETHER IN CONTRACT
OR TORT OR BASED ON A WARRANTY, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.


 


ARTICLE 13


INSURANCE


 


13.1                           Catalent Insurance. During
the Term of this Agreement and for a period of at least three (3) years
following the expiration or earlier termination of this Agreement, Catalent
shall provide and maintain in full force and effect, at no cost to Client, usual
and customary insurance coverage for all obligations relating to or arising
under this Agreement, including, without limitation, products liability, general
liability, and related insurance coverage with policy limits in the minimums
set forth below.


 


(A)                              Commercial General Liability insurance with a per-occurrence
limit of not less than the Euro equivalent of [***];


 






*** CONFIDENTIAL TREATMENT
REQUESTED


 


16

















 


(B)                                Products and Completed Operations Liability insurance with a
per-occurrence limit of not less than the Euro equivalent of [***];


 


(C)                                Local equivalent of Workers’ Compensation and Employer’s
Liability insurance, with statutory limits for Workers’ Compensation and
Employer’s Liability limits at least equal to the Euro equivalent of [***] per
accident;


 


(D)                               Professional Services Errors & Omissions Liability
insurance with per-claim and aggregate limits at least equal to the Euro
equivalent of [***];


 


(E)                                 Umbrella/Excess Liability limits of Euro equivalent of [***]
per incident; and


 


(F)                                 Insurance coverage for Others Property: Euro equivalent of [***]
per incident. Such all-risk property insurance coverage shall cover property
which is owned by Client and is located at Catalent’s facilities.


 


The Parties hereby acknowledge and agree that Catalent may
self-insure all or any portion of the required insurance.


 


Each insurance policy which is required under this Agreement,
other than self-insurance, shall be obtained from an insurance carrier with an
A.M. Best rating of at least A-VII.


 


Prior to execution of this Agreement, and at anytime at the
request of Client, Catalent shall supply Client with a certificate of insurance
as evidence of the insurance coverage required herein, and said certificate
shall provide not less than thirty (30) days written notice of cancellation, termination,
non-renewal or material change which reduces the terms and conditions of the
coverage below that required in this Agreement. Client shall be listed as an
additional insured on the insurance policy obtained by Catalent pursuant to
Sections 13.1(A) and (B). Such additional insured status shall end upon
termination or expiration of this Agreement unless the policies are written on
claims made basis, in which case such additional insured status will continue
for the period of time Catalent is required to maintain such insurance under
the terms of this Agreement. Catalent shall obtain a waiver from any insurance
carrier with whom Catalent carries Workers’ Compensation insurance releasing
its subrogation rights against Client. If Catalent fails to obtain replacement
insurance (without any gap in coverage) meeting the requirements of this
Agreement and such failure is not cured, or a plan for curing such breach has
not been developed which is reasonably accepted by the Client within thirty (30)
days of written notice of such failure, then Client shall have the right to
immediately terminate this Agreement in accordance with Section 10.3.


 


13.2                           Client Insurance. During
the Term of this Agreement and for a period of at least three (3) years
following the expiration or earlier termination of this Agreement, Client shall
provide and maintain in full force and effect, at no cost to Catalent, usual
and customary insurance coverage for all obligations relating to or arising
under this Agreement, including, without limitation, products liability, general
liability, and related insurance coverage with policy limits in the minimums
set forth below:


 


(A)                              Commercial General Liability Insurance with a per occurrence
limit of not less than the Euro equivalent of [***];


 


(B)                                Products and Completed Operations Liability Insurance (including
coverage for Products used in clinical trials) with a per occurrence limit of
not less than the Euro equivalent of [***];


 






*** CONFIDENTIAL TREATMENT
REQUESTED


 


17

















 


(C)                                Local equivalent of Workers’ Compensation and Employer’s
Liability insurance, with statutory limits for Workers’ Compensation and
Employer’s Liability limits at least equal to the Euro equivalent of [***] per
accident; and


 


(D)                               Cargo/Transit Insurance to cover shipments up to the Euro
equivalent of [***] in value, per shipment.


 


The Parties hereby acknowledge and agree that Client may
self-insure all or any portion of the required insurance. Client shall maintain
levels of insurance sufficient to meet its obligations under this Agreement. In
the event that any of the required policies of insurance are written on a
claims-made basis, then such policies shall be maintained during the entire
Term and for a period of not less than three (3) years following the
expiration or termination of this Agreement. Catalent shall be named as additional
insured under the Products and Completed Operations Liability insurance
policies with respect to the products and completed operations outlined in this
Agreement.


 


Client shall furnish certificates of insurance evidencing the
required insurance policies and additional insured status to Catalent as soon
as practicable after the Effective Date and within thirty (30) business days
after renewal of such policies. Each insurance policy that is required under
this Agreement shall be obtained from an insurance carrier with an A.M. Best
rating of at least A-VII.


 


ARTICLE 14


NOTICE


 


All notices and other communications hereunder shall be in
writing and shall be deemed given: (A) when delivered personally; (B) when
delivered by facsimile transmission (receipt verified); (C) when received or
refused, if mailed by registered or certified mail (return receipt requested), postage
prepaid; or (D) when delivered if sent by express courier service, to the
Parties at the following addresses (or at such other address for a Party as
shall be specified by like notice; provided, that notices of a change of
address shall be effective only upon receipt thereof):


 


	
  To
  Client:

  	
  Talecris
  Biotherapeutics GmbH

  
	
   

  	
  Lyoner
  Strasse 15

  
	
   

  	
  D-60528
  Frankfurt am Main, Niederrad

  
	
   

  	
  Deutsehland

  
	
   

  	
  Attn:
  General Manager

  
	
   

  	
  Facsimile:
  +49 69 660593-110 or 660593-598

  
	
   

  	
   

  
	
  To
  Catalent:

  	
  Catalent
  France Limoges SAS

  
	
   

  	
  Rue
  de Dion Bouton

  
	
   

  	
  ZI
  Nord

  
	
   

  	
  BP
  1547

  
	
   

  	
  87021
  LIMOGES Cedex 9

  
	
   

  	
  France

  
	
   

  	
  Attn:
  General Manager

  
	
   

  	
  Facsimile:
  +33 5 55 37 74 54

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 


18














 


	
  With
  a copy to:

  	
  Catalent
  Pharma Solutions, LLC

  
	
   

  	
  14
  Schoolhouse Road

  
	
   

  	
  Somerset,
  NJ 08873

  
	
   

  	
  Attn:
  Associate General Counsel

  
	
   

  	
  Facsimile:
  +1 (732) 537-6491

  



 


ARTICLE 15


MISCELLANEOUS


 


15.1         Entire
Agreement; Amendments. This Agreement, the Exhibits and any amendments
thereto constitute the entire understanding between the Parties and supersede
any contracts, agreements or understanding (oral or written) of the Parties
with respect to the subject matter hereof. No term of this Agreement or any Exhibit hereto
may be amended except upon written agreement of both Parties, unless otherwise
provided in this Agreement. All Exhibits to this Agreement are incorporated
herein by reference. Notwithstanding the foregoing, in the event of a conflict
between this Agreement and any such Exhibit, the terms of this Agreement shall
control.


 


15.2         Captions.
The captions in this Agreement are for convenience only and are not to be
interpreted or construed as a substantive part of this Agreement


 


15.3         Further
Assurances. The Parties agree to execute, acknowledge and deliver such
further instruments and to take all such other incidental acts as may be
reasonably necessary or appropriate to carry out the purpose and intent of this
Agreement.


 


15.4         No
Waiver. Failure by either Party to insist upon strict compliance with any
term of this Agreement in any one or more instances shall not be deemed to be a
waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure.


 


15.5         Severability.
If any term of this Agreement is declared invalid or unenforceable by a court
or other body of competent jurisdiction, the remaining terms of this Agreement
shall continue in full force and effect and the Parties shall cooperate to
agree upon a substitute term for the invalid or unenforceable term which most
closely reflects their current intent and meets legal requirements.


 


15.6         Independent
Contractors/Subcontracting. The relationship of the Parties is that of
independent contractors, and neither Party shall incur any debts or make any
commitments for the other Party except to the extent expressly provided in this
Agreement. Nothing in this Agreement is intended to create or shall be
construed as creating between the Parties the relationship of joint ventures, co-partners,
employer/employee or principal and agent.


 


Catalent may subcontract all or part of the Testing and
Packaging Services, subject to Client’s prior written approval and possible
audit of such subcontractor, with the terms of such audit to be set forth in the
Quality Agreement. Such arrangement(s) shall create a
contractor-subcontractor relationship between Catalent and the third party and,
as such, Client shall not enter into any contractual relationship with third
party subcontractor(s). The subcontracting by Catalent of any activities
hereunder shall not relieve Catalent of any of its duties or obligations
arising under this Agreement.


 


15.7         Successors
and Assigns. This Agreement shall be binding upon and inure to the benefit
of the Parties, their successors and permitted assigns. Neither Party may
assign this Agreement, in whole or in part, without the prior written consent
of the other Party, except that either Party may, without the other Party’s
consent, assign this Agreement to an Affiliate or to a successor to
substantially all of the business


 


19

















 


or assets of the assigning company. For the avoidance of
doubt, this Agreement may be transferred in the event of a change in control.


 


15.8         Governing
Law. This Agreement shall be governed by and construed under the laws of
the State of New York excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale
of Goods shall not apply to tills Agreement.


 


15.9         Arbitration.
The parties intend to enter a separate dispute resolution agreement, to be
attached hereto and incorporated herein. In the interim, if any dispute, controversy
or disagreement (“Dispute”) arises
between the Parties, such Dispute shall be presented to the respective
presidents or senior executives of Catalent and Client for their consideration
and resolution. If such Parties cannot reach a resolution of the Dispute within
thirty (30) business days, then all disputes arising out of or in connection
with the present contract shall be finally settled under the Rules of
Arbitration of the International Chamber of Commerce by one or more arbitrators
appointed in accordance with the said Rules. The arbitration shall be conducted
in New York.


 


15.10       Prevailing
Party. In any dispute resolution proceeding between the Parties in
connection with this Agreement, the prevailing Party shall be entitled to its
reasonable attorney’s fees and costs in such proceeding.


 


15.11       Counterparts.
This Agreement may be executed in one or more counterparts, each of which shall
be deemed an original but all of which together shall constitute one and the
same instrument. Any photocopy, facsimile or electronic reproduction of the
executed Agreement shall constitute an original.


 


15.12       Publicity.
Neither Party shall make any press release or other public disclosure regarding
this Agreement or the transactions contemplated hereby without the other’Party’s
express prior written consent, except as required under applicable law or by any
governmental agency, in which case the Party required to make the press release
or public disclosure shall use reasonable efforts to obtain the approval of the
other Party as to the form, nature and extent of the press release or public
disclosure prior to issuing the press release or making the public disclosure. Notwithstanding
the foregoing, Catalent agrees that Client may make such disclosures as are
required to meet legal requirements under applicable regulatory and securities
laws. It is anticipated that a joint press release shall be submitted to both
Parties for approval shortly after execution of this Agreement.


 


15.13       Setoff.
Without limiting Catalent’s rights under law or in equity, Catalent and its
Affiliates, parent or related entities, collectively or individually, may
exercise a right of set-off against any and all amounts due to Catalent from
Client. For purposes of this Article, Catalent, its Affiliates, parent or
related entities shall be deemed to be a single creditor.


 


15.14       Survival.
The rights and obligations of the Parties shall continue under Articles 9 (Confidentiality),
11 (Indemnification), 12 (Limitation of Liability), 13 (Insurance), to the
extent expressly stated therein, 14 (Notice), 15 (Miscellaneous) and Sections
3.6 (Shipping and Risk of Loss), 3.7 (Failure to take Delivery), 4.7 (Terms of
Agreement Govern), 4.8 (Secondary Source), 10.4 (Transition; Wind-down) and
10.5 (Effect of Termination), notwithstanding expiration or termination of this
Agreement.


 


15.15       Force
Majeure. Except as to payments required under this Agreement, neither Party
shall be liable in damages for, nor shall this Agreement be terminable or
cancelable by reason of, any delay or default in such Party’s performance
hereunder if such default or delay is caused by unpreventable events beyond
such Party’s reasonable control including, but not limited to, acts of God, regulation
or law or other action or failure to act of any government or agency thereof, war
or insurrection, civil commotion,


 


20

















 


destruction of production facilities or materials by
earthquake, fire, flood or storm, epidemic, or failure of public utilities or
common carriers; provided however, that the Party seeking relief hereunder
shall immediately notify the other Party of such cause(s) beyond such
Party’s reasonable control. The Party affected by such Force Majeure event
shall use Reasonable Efforts to (i) overcome the Force Majeure event and (ii) mitigate
or limit damages to the non-affected Party. If any Force Majeure event shall
continue in effect for ninety (90) business days, or if the non-affected Party
shall reasonably determine that any Force Majeure Event will by its nature
continue in effect for ninety (90) business days or longer, then the Party not
the subject of such Force Majeure event may by notice to the other terminate
this Agreement.


 


{Signature Page Follows.}


 


21

















 


IN WITNESS
WHEREOF, Client and Catalent have executed
this Agreement as of the date first set forth above.


 


 


	
  TALECRIS
  BIOTHERAPEUTICS GMBH

  	
   

  	
  CATALENT
  FRANCE LIMOGES SAS

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/
  Joel Abelson

  	
   

  	
   

  	
  By:

  	
  /s/
  Jean TRONCHET

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Joel
  Abelson

  	
   

  	
   

  	
  Name:

  	
  Jean
  TRONCHET

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  SVP
  & GM

  	
   

  	
   

  	
  Title:

  	
  General
  Manager

  



 


	
  APPROVED AS TO

  	
   

  
	
  LEGAL FORM

  	
   

  
	
  AL 4-14-08

  	
   

  
	
  TALECRIS BIOTHERAPEUTICS

  	
   

  
	
  LAW DEPT.

  	
   

  



 


22

















 


Exhibit A


 


Products


 


1. Immunoglobulin Intravenous (Human)


Chromatography Purified (10% IGIV-C)


 


	
  10%

  	
  10
  m1

  
	
  10%

  	
  50
  m1

  
	
  10%

  	
  100
  ml

  
	
  10%

  	
  200 ml

  



 


2. Human - Albumin


 


	
  20

  	
  50
  m1

  
	
  20

  	
  100
  ml

  
	
  25

  	
  50
  ml

  
	
  25

  	
  l00 ml

  



 


3. Alpha-1 Proteinase Inhibitor + diluent


 


1000 mg


 

















 


Exhibit B


 


Specifications


 

















 


	
  

  	
  FINISHED
  PRODUCT

  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  



 


	
  Title

  	
  Number

  
	
  Human albumin 20%-50 ml

  	
  L07/065-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This specification is made according to Talecris
Release Specification T.02.28-01 EU, Human albumin 20% -50  ml


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Ta1ecris Reference

  
	
  Appearance

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   Precipitin test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-113

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.   (1)Grabar Williams
  (immunoelectrophoresis)

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-041

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volumetric fill check, mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-007

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH of 1% protein composition

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-012

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sodium (Atomic Absorption Spectrometry), mmol/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-048

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Potassium (Atomic Absorption Spectrometry), mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-050

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein Concentration (Biuret), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-052

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Protein Composition (Capillary Electrophoresis),
  %  albumin

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Polymer and Aggregates (HPLC), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  N-acetyl-DL-Tryptophan (HPLC):

  	
   

  	
   

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  



 






(1) Tests outsourced


(2) Methods used by Catalent will be internal methods
equivalent to the Talecris ones.


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  18/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 20%-50 ml

  	
  L07/065-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Ta1ecris Reference

  
	
  Sodium Caprylate (Ion Chromatography)

  	
   

  	
   

  	
   

  	
  CS-000-BC-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Prekallikrein Activator, IU/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Aluminium (Atomic Absorption Spectrometry), μg/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-049

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Heme ( at 403 nm), A

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-026

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Acetone, % W/V

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-017

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced


(2) Methods used by Catalent will be internal methods
equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  19/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 20%-100 ml

  	
  L07/066-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This specification is made according to Talecris Release Specification
T.02.28-01 EU, Human albumin 20% - 100 ml 


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Appearance

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   Precipitin test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-113

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.   (1) Grabar Williams
  (immunoelectrophoresis)

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-04l

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volumetric fill check, mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-007

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH of 1% protein composition

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-012

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sodium (Atomic Absorption Spectrometry), mmol/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-048

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Potassium (Atomic Absorption Spectrometry), mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-050

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein Concentration (Biuret), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-052

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Protein Composition (Capillary Electrophoresis),
  % albumin

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Polymer and Aggregates (HPLC), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  N-acetyl-DL-Tryptophan (HPLC):

  	
   

  	
   

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  



 






(1) Tests outsourced


(2) Methods used by Catalent will be internal
methods equivalent to the Talecris ones 


 


Technical Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  20/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 














 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 20%-100 ml

  	
  L07/066-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Sodium Caprylate (Ion
  Chromatography):

  	
   

  	
   

  	
   

  	
  CS-000-BC-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Prekallikrein Activator,IU/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Aluminium (Atomic
  Absorption Spectrometry), μg/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-049

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Heme ( at 403 nm), A

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-026

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Acetone, % W/V

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-017

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced



(2) Methods used by
Catalent will be internal methods equivalent to the Talecris ones


 


Technical Quality
Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  21/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 25%-50 ml

  	
  L07/067-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This
specification is made according to Talecris Release Specification T.02.28-01
EU, Human albumin 25% -50  ml


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Appearance

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   Precipitin
  test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-113

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.   (1)Grabar
  Williams (immunoelectrophoresis)

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-041

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volumetric
  fill check, mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-007

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH
  of 1% protein composition

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-012

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sodium
  (Atomic Absorption Spectrometry), mmol/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-048

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Potassium
  (Atomic Absorption Spectrometry), mmol/g protein

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-050

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein
  Concentration (Biuret), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-052

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Protein
  Composition (Capillary Electrophoresis), % albumin

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Polymer
  and Aggregates (HPLC), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  N-acetyl-DL-Tryptophan
  (HPLC):

  	
   

  	
   

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  22/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 25%-50 ml

  	
  L07/067-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Sodium
  Caprylate (Ion Chromatography):

  	
   

  	
   

  	
   

  	
  CS-000-BC-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Prekallikrein
  Activator, IU/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Aluminium
  (Atomic Absorption Spectrometry), μg/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-049

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Heme
  ( at 403 nm), A

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-026

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Acetone,
  % W/V

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-017

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)
  Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced 

(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  23/34

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 25%-100 ml

  	
  L07/068-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This
specification is made according to Talecris Release Specification T.02.28-01
EU, Human albumin 25% -100  ml


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Appearance

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   Precipitin
  test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-113

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2. (1)Grabar
  Williams (immunoelectrophoresis)

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-041

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volumetric
  fill check, mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-007

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH
  of 1% protein composition

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-012

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sodium
  (Atomic Absorption Spectrometry), mmol/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-048

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Potassium
  (Atomic Absorption Spectrometry), mmol/g protein

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-050

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein
  Concentration (Biuret), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-052

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)Protein Composition
  (Capillary Electrophoresis), % albumin

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Polymer
  and Aggregates (SE-HPLC), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  N-acetyl-DL-Tryptophan
  (SE-HPLC):

  	
   

  	
   

  	
   

  	
  CS-000-BC-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  24/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Human albumin 25%-100 ml

  	
  L07/068-01

  
	
   

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Sodium
  Caprylate (Ion Chromatography):

  	
   

  	
   

  	
   

  	
  CS-000-BC-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/g
  protein

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    mmol/L

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Prekallikrein
  Activator, IU/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Aluminium
  (Graphite Fumace Atomic Absorption Spectrometry), μg/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-049

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Heme
  ( at 403 nm), A

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-026

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Acetone
  (colorimetric), % W/V

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-017

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced 

(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  25/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Prolastin 1000mg, Lyophilisat

  	
  L07/069-01

  
	
  (Alpha-1 Proteinase Inhibitor (Human))

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This
specification is made according to Talecris Release Specification T.02.28-0l
EU, Alpha-1 Proteinase Inhibitor, 1000 mg


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Appearance:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.   Before
  reconstitution

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.   After
  reconstitution

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-004

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:
  Precipitin test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-l13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Solubility
  Time, min.

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-004

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vacuum

  	
   

  	
  [***]

  	
   

  	
  In process Test

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-011

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Moisture
  (Abderhalden), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-022

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sodium
  (Atomic Absorption Spectrometry), mmol/L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-048

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Chloride,
  mmol/ L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-006

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phosphate
  (Ion Chromatography), mmol/ L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-058

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Citrate
  (Ion Chromatography), mmol/ L

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-058

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein (Kjeldahl),
  mg/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-053

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical Quality
Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  26/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 














 


	
  

  	
  FINISHED
  PRODUCT

  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Prolastin 1000mg, Lyophilisat 

  	
  L07/069-01

  
	
  (Alpha-1 Proteiuase Inhibitor (Human))

  	
  Replaces number

  
	
   

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  (1)Protein Composition
  (Capillary Electrophoresis):

  	
   

  	
   

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Albumin,
  %

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Alpha-1
  globulin, %

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Sum
  of alpha-2, Beta and Gamma globulins, %

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sucrose
  (Ion Chromatography), %

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-060

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Polyethylene
  Glycol (TLC), ppm

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-039

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Tris
  (hydroxymethyl) amino methane (TLC), ppm

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-040

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Alpha-l
  Proteinase Inhibitor:

  	
   

  	
   

  	
   

  	
  CS-000-BF-040

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Concentration,
  mg/mL

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Vial content,
  mg

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Specific
  Activity, mg/mg Protein

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-021

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Isoagglutinin
  Titer:

  	
   

  	
   

  	
   

  	
  CS-000-BF-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Al

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-B

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  27/34

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Gamunex 10%

  	
  L07/070-01

  
	
  Immune Globulin Intravenous
  (Human), 10% Chromatography

  	
  Replaces number

  
	
  (IGIV-C)

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


This
specification is made according to Talecris Release Specification T.02.28-08
EU, Gamunex 10% (IGIV-C).


 


DESCRIPTION


 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Appearance:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.   Clarity

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.   Colour

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identity:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.   Precipitin
  test:

  	
   

  	
   

  	
   

  	
  CS-000-BB-113

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Human

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Bovine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Equine

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.   (1)Grabar
  Williams (immunoelectrophoresis)

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-041

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volumetric
  fill check, mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-007

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  pH
  of 1% protein solution

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-012

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Osmolality,
  mOsmol/kg solvent

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-032

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protein
  Concentration (Biuret), mg/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-052

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Protein
  Composition (Capillary Electrophoresis), % gamma globulin

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-045

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Glycine
  (HPLC), M

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-036

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  28/34

  



 






***
CONFIDENTIAL TREATMENT REQUESTED


 

















 


	
  

  	
  FINISHED
  PRODUCT
  SPECIFICATION

  	
   

  	
  Réf: F01LQG144 / 5

  
	
   

  	
   

  



 


	
  Title

  	
  Number

  
	
  Gamunex 10%

  	
  L07/070-01

  
	
  Immune Globulin Intravenous
  (Human), 10% Chromatography

  	
  Replaces number

  
	
  (IGIV-C)

  	
  /

  
	
  Compiled
  by Regulatory Affairs Manager,

  date and name 

  	
   

  	
  Approved
  by QC Manager,

  date and name

  	
   

  	
  Approved
  by Talecris Biotherapeutics

  GmbH, Head of Quality Assurance 

  
	
  04/04/2008

  	
   

  	
  07/04/2008

  	
   

  	
  28.03.08

  
	
  /s/ Rosa Mari PORTO

  	
   

  	
  /s/
  Maria FILALI

  	
   

  	
  /s/ Cordula SCHNEIDER 

  
	
  Rosa Mari PORTO

  	
   

  	
  Maria
  FILALI

  	
   

  	
  Cordula SCHNEIDER

  
						



 


	
  TESTS

  	
   

  	
  SPECIFICATIONS

  	
   

  	
  METHODS / SOP

  (2)Talecris Reference

  
	
  Sodium
  Caprylate (Ion Chromatography),μg / mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-057

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Molecular
  Weight (HPLC):  

  	
   

  	
   

  	
   

  	
  CS-000-BC-034

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Monomer and
  Dimer, %

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Aggregate, %

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Prekallikrein
  Activator, IU/mL

  	
   

  	
  [***]

  	
   

  	
  CS-000-BC-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Anticomplement
  Assay, C’H50/mg IgG

  	
   

  	
  [***]

  	
   

  	
  CS-000-BF-035

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hepatitis
  B Antibody, IU/g IgG

  	
   

  	
  [***]

  	
   

  	
  ELISA (ES-180-LC-072-00)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Isoagglutinin
  Titer:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-Al

  	
   

  	
  [***]

  	
   

  	
  CS-000-BF-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-B

  	
   

  	
  [***]

  	
   

  	
  CS-000-BF-047

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    -    Anti-D

  	
   

  	
  [***]

  	
   

  	
  CS-000-BF-049

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sterility

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-066

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)Pyrogen

  	
   

  	
  [***]

  	
   

  	
  CS-000-BB-126

  



 






(1) Tests outsourced


(2) Methods
used by Catalent will be internal methods equivalent to the Talecris ones


 


Technical
Quality Agreement


	
  Talecris
  Biotherapeutics GmbH /Catalent France Limoges sas

  	
  29/34

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


Exhibit C


 


Territory


 


The
Manufacturer shall perform the Services for the distribution of the FP in the
following countries:


 


Austria,
Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary,
Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain,
Sweden, Switzerland, United Kingdom, and such other countries as are added (or
removed) by Talecris from time to time (collectively, the “Territory”).


 

















 


Exhibit D


 


Price


 


	
  Planned Compensation 2008 - DRAFT

  	
   

  	
  Exhibit D

  
	
  Position

  	
   

  	
  Activity

  	
   

  	
  Price unit

  	
   

  	
  Price in €

  
	
   

  	
   

  	
  Labeling &
  packaging

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Labeling of products

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Lot
  change

  	
   

  	
  € per sublot

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Lot size 100 - 499

  	
   

  	
  € per vial

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Lot size 500 - 4999

  	
   

  	
  € per vial

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Lot size > 5000

  	
   

  	
  € per vial

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Water for Injection

  	
   

  	
  € per vial

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Barcoding of products

  	
   

  	
  € per unit

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Procurement of secondary packaging material

  	
   

  	
  € / unit

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Testing

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Management of test samples (FCP)

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Shipment of samples to laboratory of outsourced
  tests

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Management of test samples (FP) for German batches

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost at internal laboratories

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Testing cost Plasbumin

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost Gamunex

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost Prolastin

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost at external laboratories

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Testing cost Plasbumin

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost Gamunex

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Testing cost Prolastin

  	
   

  	
  € per batch

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Monthly fix costs

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facility costs

  	
   

  	
  € per pallet per month

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Storage of reference samples

  	
   

  	
  € per year

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Destruction of reference samples*

  	
   

  	
  € per year

  	
   

  	
  [***]

  



 






*** CONFIDENTIAL TREATMENT
REQUESTED


 

















 


	
   

  	
   

  	
  Extraordinary work

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Management of recalls

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Keep FP on hold at Catalent

  	
   

  	
  € per pallet per month

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Destruction of products

  	
   

  	
  € per ton

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Extraordinary charges

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Quality Control

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Lab technician

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Administration

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Packaging

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Labeling personnel

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Warehousing personnel

  	
   

  	
  € / H

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Regulatory

  	
   

  	
  € / H

  	
   

  	
  [***]

  



 






	
   

  	
   

  	
  *  Charges only
  valid after 4th year

  	
   

  	
   

  	
   

  	
   

  



 






*** CONFIDENTIAL TREATMENT REQUESTED


 

















 


Exhibit E


 


Cost of
Goods 

as of January 2008 effective until December 2008


 


	
  Product

  	
   

  	
  Size

  	
   

  	
  Cost (in Euro)

  
	
  Immunoglobulin
  Intravenous (Human) Chromatography Purified (10% IGIV-C)

  	
   

  	
   

  	
   

  	
   

  
	
  10%

  	
   

  	
  10
  ml

  	
   

  	
  [***]

  
	
  10%

  	
   

  	
  50
  m1

  	
   

  	
  [***]

  
	
  10%

  	
   

  	
  100
  ml

  	
   

  	
  [***]

  
	
  10%

  	
   

  	
  200
  ml

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Human-Albumin

  	
   

  	
   

  	
   

  	
   

  
	
  20%

  	
   

  	
  50
  ml

  	
   

  	
  [***]

  
	
  20%

  	
   

  	
  100
  ml

  	
   

  	
  [***]

  
	
  25%

  	
   

  	
  50
  ml

  	
   

  	
  [***]

  
	
  25%

  	
   

  	
  100
  ml

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Alpha-1 Proteinase
  Inhibitor + diluent

  	
   

  	
   

  	
   

  	
   

  
	
  1000 mg

  	
   

  	
  50 ml product bottle + 40 ml diluent in 50 ml bottle

  	
   

  	
  [***]

  



 






***
CONFIDENTIAL TREATMENT REQUESTED