Document:

Exhibit
10.35

 EXECUTION COPY

 

***TEXT
OMITTED AND SUBMITTED SEPARATELY

PURSUANT
TO CONFIDENTIAL TREATMENT REQUEST

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

 

 

 

EUROPEAN PRODUCT SALES AGREEMENT (PHASE I)

 

BY AND BETWEEN

 

BAYER BIOLOGICALS S.R.L.

 

MILAN, ITALY

 

AND

 

TALECRIS BIOTHERAPEUTICS, GMBH

 

FRANKFURT, GERMANY

 

TABLE OF CONTENTS

 

	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  
	
  ARTICLE 1

  PURCHASE AND SALE

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.1

  	
  General

  	
  5

  
	
  1.2

  	
  Clayton Facility

  	
  36

  
	
  1.3

  	
  Contact Persons

  	
  6

  
	
   

  	
   

  	
   

  
	
  ARTICLE 2

  PRICING

  	
  7

  
	
   

  	
   

  	
   

  
	
  2.1

  	
  CONFIDENTIAL TREATMENT REQUESTED

  	
  7

  
	
  2.2

  	
  Invoices

  	
  7

  
	
  2.3

  	
  CONFIDENTIAL TREATMENT
  REQUESTED

  	
  7

  
	
  2.4

  	
  Legacy Products

  	
  7

  
	
  2.5

  	
  Other Costs

  	
  7

  
	
  2.6

  	
  Payment

  	
  8

  
	
  2.7

  	
  Payment Disputes

  	
  8

  
	
  2.8

  	
  CONFIDENTIAL TREATMENT
  REQUESTED

  	
  8

  
	
   

  	
   

  	
   

  
	
  ARTICLE 3

  SUPPLY CHAIN COORDINATION

  	
  8

  
	
   

  	
   

  	
   

  
	
  3.1

  	
  Forecasts

  	
  8

  
	
  3.2

  	
  Delivery of Finished Products

  	
  9

  
	
   

  	
   

  	
   

  
	
  ARTICLE 4

  PRODUCTS

  	
  9

  
	
   

  	
   

  	
   

  
	
  4.1

  	
  Purchase Orders

  	
  9

  
	
  4.2

  	
  Shipments

  	
  9

  
	
  4.3

  	
  Specification

  	
  9

  
	
  4.4

  	
  Acceptance and Rejection

  	
  10

  
	
  4.5

  	
  Title

  	
  11

  
	
   

  	
   

  	
   

  
	
  ARTICLE 5

  MANUFACTURING REQUIREMENTS

  	
  11

  
	
   

  	
   

  	
   

  
	
  5.1

  	
  Manufacturing Procedures

  	
  11

  
	
  5.2

  	
  Revisions to Manufacturing
  Procedures

  	
  12

  
	
  5.3

  	
  Revisions to Manufacturing
  Processes

  	
  12

  
	
  5.4

  	
  Batch Records

  	
  12

  
	
  5.5

  	
  Batch Sizes

  	
  12

  
	
  5.6

  	
  Deviation Report

  	
  13

  
	
  5.7

  	
  Records

  	
  13

  
	
   

  	
   

  	
   

  
	
  ARTICLE 6

  QUALITY ASSURANCE

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.1

  	
  Quality Assurance

  	
  13

  
	
  6.2

  	
  Testing

  	
  14

  
	
  6.3

  	
  Labeling and Documentation

  	
  14

  
	
   

  	
   

  	
   

  
	
  ARTICLE 7

  REGULATORY REQUIREMENTS

  	
  15

  
	
   

  	
   

  	
   

  
	
  7.1

  	
  Compliance with Regulations

  	
  15

  
	
  7.2

  	
  Inspection of Facilities

  	
  15

  
				

 

i

 

	
  7.3

  	
  Regulatory Filings

  	
  16

  
	
  7.4

  	
  Regulatory Approvals

  	
  16

  
	
   

  	
   

  	
   

  
	
  ARTICLE 8

  DOCUMENTATION AND RESERVE SAMPLES

  	
  16

  
	
   

  	
   

  	
   

  
	
  ARTICLE 9

  RISK OF LOSS

  	
  17

  
	
   

  	
   

  	
   

  
	
  9.1

  	
  Storage

  	
  17

  
	
  9.2

  	
  Risk of Loss

  	
  17

  
	
   

  	
   

  	
   

  
	
  ARTICLE 10

  CONFIDENTIALITY

  	
  17

  
	
   

  	
   

  	
   

  
	
  10.1

  	
  General

  	
  17

  
	
  10.2

  	
  Exceptions

  	
  17

  
	
   

  	
   

  	
   

  
	
  ARTICLE 11

  INDEMNITY AND INSURANCE

  	
  18

  
	
   

  	
   

  	
   

  
	
  11.1

  	
  Indemnity

  	
  18

  
	
  11.2

  	
  Indemnification Process

  	
  18

  
	
  11.3

  	
  Insurance

  	
  19

  
	
  11.4

  	
  Insurance Recoveries

  	
  19

  
	
  11.5

  	
  Latent Defects

  	
  19

  
	
  11.6

  	
  Incentive Bonus

  	
  19

  
	
  11.7

  	
  Limitation on Damages

  	
  20

  
	
   

  	
   

  	
   

  
	
  ARTICLE 12

  NONCONFORMING PRODUCT AND RECALLS

  	
  20

  
	
   

  	
   

  	
   

  
	
  12.1

  	
  Nonconforming Product

  	
  20

  
	
  12.2

  	
  General Requirements

  	
  20

  
	
  12.3

  	
  Distribution and Use Records

  	
  20

  
	
  12.4

  	
  Adverse Events

  	
  21

  
	
  12.5

  	
  Customer Notification of
  Adverse Reactions

  	
  21

  
	
  12.6

  	
  Withdrawals and Recalls

  	
  21

  
	
  12.7

  	
  Complaints

  	
  22

  
	
   

  	
   

  	
   

  
	
  ARTICLE 13

  TERM AND TERMINATION

  	
  22

  
	
   

  	
   

  	
   

  
	
  13.1

  	
  Term

  	
  22

  
	
  13.2

  	
  Termination for Cause

  	
  22

  
	
  13.3

  	
  Termination for Force Majeure

  	
  22

  
	
  13.4

  	
  Termination for Insolvency

  	
  23

  
	
  13.5

  	
  Effect of Termination

  	
  23

  
	
  13.6

  	
  Remedies

  	
  24

  
	
  13.7

  	
  Special Assistance

  	
  24

  
	
   

  	
   

  	
   

  
	
  ARTICLE 14

  INTELLECTUAL PROPERTY

  	
  24

  
	
   

  	
   

  	
   

  
	
  14.1

  	
  Intellectual Property Rights

  	
  25

  
	
   

  	
   

  	
   

  
	
  ARTICLE 15

  REPRESENTATIONS AND WARRANTIES AND DISCLAIMER

  	
  25

  
	
   

  	
   

  	
   

  
	
  15.1

  	
  Debarmemt

  	
  25

  
	
  15.2

  	
  Compliance

  	
  25

  
	
  15.3

  	
  Representations and
  Warranties

  	
  25

  

 

ii

 

	
  15.4

  	
  Disclaimer

  	
  27

  
	
   

  	
   

  	
   

  
	
  ARTICLE 16

  MISCELLANEOUS

  	
  27

  
	
   

  	
   

  	
   

  
	
  16.1

  	
  Governing Law

  	
  27

  
	
  16.2

  	
  Assignment

  	
  28

  
	
  16.3

  	
  Severability

  	
  28

  
	
  16.4

  	
  Waiver

  	
  28

  
	
  16.5

  	
  Entire Agreement

  	
  28

  
	
  16.6

  	
  Survival

  	
  28

  
	
  16.7

  	
  Force Majeure

  	
  29

  
	
  16.8

  	
  Notices

  	
  29

  
	
  16.9

  	
  Captions

  	
  30

  
	
  16.10

  	
  Dispute Resolution

  	
  30

  
	
  16.11

  	
  Independent Contractor

  	
  32

  
	
  16.12

  	
  English Language

  	
  32

  
	
  16.13

  	
  Set-Off

  	
  32

  
	
  16.14

  	
  Defined Terms

  	
  32

  
	
   

  	
   

  	
   

  
	
  EXHIBITS TO THE EUROPEAN PRODUCT SALES
  AGREEMENT (PHASE I)

  	
  34

  

 

iii

 

AMENDED AND RESTATED

EUROPEAN PRODUCT SALES AGREEMENT (PHASE 1)

 

This AMENDED
AND RESTATED EUROPEAN PRODUCT SALES AGREEMENT (PHASE 1) (this “Agreement”) is
entered into as of April 1, 2007 (“Effective Date”), by and between Talecris
Biotherapeutics, GmbH, (“Talecris GmbH”) of Frankfurt, Germany and Bayer
Biologicals S.r.l., Viale Certosa 130, Milan, Italy, Companies Register
C.C.I.A.A. Milano n 1717/97 (“Rosia,” along with Talecris GmbH, the “Parties”).
This Agreement, unless terminated earlier pursuant to Article 13 of this
Agreement, will expire on December 31, 2008.

 

WHEREAS, as
part of Talecris Biotherapeutics Inc.’s (“Talecris Inc.”) purchase of the
designated assets of Bayer HealthCare LLC, Rosia agreed to continue to
purchase, import, test, package and distribution in Europe certain final
container Products that were originally manufactured, processed and tested by
Talecris Inc. at the Clayton, North Carolina facility (“Clayton Facility”) (the
“Rosia I Agreement”).

 

WHEREAS, after
April 2007 it was anticipated that Talecris Inc. would have an affiliate in
Europe who would become the authorized importer and manufacturer of the
Finished Products and Rosia would then enter a new agreement wherein its role
was to be limited to certain packaging, labeling and distribution services only
(the “Rosia II Agreement”);

 

WHEREAS, on
January 2006, Talecris GmbH was established but the conditions necessary for
implementation of the Rosia II Agreement were nevertheless not met and as a
consequence the Parties wish to extend the terms of the Rosia I Agreement with
some modifications including the replacement of Talecris Inc. with Talecris
GmbH to account for Talecris GmbH’s new responsibility for the importation and
distribution of Finished Products in Europe; and

 

WHEREAS, Rosia
has agreed to extend the terms of the Rosia I Agreement with some modifications
including the replacement of Talecris Inc. with Talecris GmbH to account for
Talecris GmbH’s new responsibility for the importation and distribution of
Finished Products in Europe; and

 

WHEREAS, it is
understood by the Parties that Talecris GmbH shall be responsible for the
performance obligations of Talecris Inc. hereunder.

 

NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties do hereby agree as follows:

 

ARTICLE 1

PURCHASE AND SALE

 

1.1           General. In
accordance with the terms and conditions of this Agreement, Talecris GmbH shall
deliver in a form ready for testing and packaging biological Products set forth
in Exhibit 1 attached hereto and incorporated herein by reference (“Contractual
Products”) 

 

5

 

to Rosia who shall purcahse such Contractual
Products and perform such testing and packaging and release as necessary to
permit the resale back to Talecris GmbH as released Finished Products for final
distribution in Europe as set forth in Exhibit 2 (“Finished Products,”
collectively with Contractual Products, “Products”). Exhibit 1 and Exhibit 2
may be amended from time to time by mutual written agreement of the Parties to
reflect additional Products developed by Talecris Inc. during the Term that the
Parties desire to become Contractual Products or Finished Products as
applicable.

 

1.2           Clayton Facility.
Talecris GmbH shall not ship any Contractual Products manufactured from any
location other than the Clayton Facility, including without limitation, any
other facility under the same manufacturing license as the Clayton Facility,
without the prior written consent of Rosia based on the registration documents,
such consent not to be unreasonably withheld. Talecris GmbH shall ensure that
Talecris Inc. maintains the manufacturing authorizations contemplated by
Section 7.1 to manufacture the Contractual Products at the Clayton Facility. Talecris
GmbH shall notify Rosia immediately of any limitation imposed on its
manufacturing authorizations for the Contractual Products.

 

1.3           Contact Person.
Talecris GmbH and Rosia shall appoint those persons listed in Exhibit 4, as may
be amended from time to time, as contact persons for all technical questions. Exhibit
4 also lists the Qualified Person as the responsible person of Rosia, in
accordance with ED directive 91/356, article 52 and Italian Law 219/06, and the
Qualified Person of Talecris GmbH responsible person for the importation in
accordance with the applicable German law, as each may be amended from time to
time, and any successor thereto. All changes and amendments to Exhibit 4 shall
be made in writing, giving sufficient advance notice to the other Party under
the circumstances.

 

1.4           Cooperation of
the Parties. In order to ensure supply and timely delivery, Talecris GmbH
shall inform Rosia immediately of any problems that may prevent Talecris GmbH
from providing timely deliveries of the Contractual Products and the Parties
shall cooperate in resolving such problems relating to the manufacture and
supply of the Contractual Products under this Agreement. In recognition of the
fact that Rosia’s business is dynamic and evolving based on market demand,
regulatory approvals and other factors, Talecris GmbH shall in good faith, but
subject to the terms of this Agreement, use commercially reasonable efforts to
seek to accommodate any reasonable request by Rosia to manufacture quantities
of the Contractual Products in excess of Talecris GmbH’s obligations hereunder;
provided, however, Talecris GmbH shall have no liability for any failure to
accommodate such request despite such efforts. The Parties shall use commercially
reasonably efforts to make temporary changes to the amount of Contractual
Products purchased and sold hereunder in order to accommodate maintenance
turnarounds at the Clayton Facility and unanticipated manufacturing constraints
and market commitments. For purposes of clarification, this Section 1.4 does
not expand or diminish the Parties’ obligations to supply and purchase, as
applicable, the Contractual Products in accordance with the Binding Forecast
set forth in Section 3.1.

 

6

ARTICLE 2

PRICING

 

2.1           [***]

 

2.2           Invoices. Following
delivery of Contractual Products to Rosia, Talecris GmbH shall issue a written
invoice to Rosia showing the type and amount of Contractual Products delivered,
and the prices thereof, as computed in accordance with this Article 2. Rosia
shall do the same with regards to Finished Product. The vials that are required
for testing and reference samples will be delivered free of charge. In Exhibit
1 are indicated the number of such vials.

 

2.3           [***]

 

2.4           Legacy Products.
Finished Products manufactured from Contractual Products purchased by Rosia
prior to the Commencement Date shall be referred to as “Legacy Products”. Talecris
GmbH shall ensure that Legacy Products are purchased by Talecris Inc. as and
when these Legacy Products are shipped to Talecris GmbH pursuant to a Binding
Forecast at the rate Rosia would have invoiced Bayer’s affiliated distributors
pursuant to the Rosia I Agreement before it was amended by this Agreement. For
example, a Legacy Product labeled for the Belgium market would be shipped to
Talecris GmbH, by  Talecris Inc. would be
invoiced the amount such product would have been invoiced to Bayer Belgium on
the same terms as were in effect during the unamended Rosia I Agreement.

 

2.5           Other Costs. Talecris
shall reimburse Rosia for the reasonably documented costs of the following
items; (i) the costs of any Contractual Product or Finished Product damaged
while stored by Rosia during the Term of this Agreement, provided that such
damage is not the result of Rosia’s negligence or willful misconduct; (ii) the
costs associated with packaging changes requested by Talecris or otherwise
required by law, including without limitation, the costs of residual packing
components; (iii) the costs associated with repackaging of Finished Product
which packaging has become damaged for reasons other than Rosia’s negligence or
willful misconduct; (iv) costs associated with packaging 

 

 

***CONFIDENTIAL
TREATMENT REQUESTED

 

7

 

and/or testing of product for the excipient
business, or samples; (v) the costs associated with change management and the
packaging technology service, as follows:

 

(a)           Refer to Exhibit 5 for the amount to
be charged for each launch (launch of a new article specification), the costs
are charged in the quarter of the submission for review by the Marketing
Authorization Holder of the article specification; and

 

(b)           Refer to Exhibit 5 for the amount to
be charged every quarter for all the article specifications that are in the
approved status at the end of the previous quarters (Maintenance of an approved
article specification).

 

(c)           The cancellation of an approved
article is free of charges, in order to minimize the number of the active
article specifications.

 

The Parties agree that (i) the Pool Samples will be shipped from
Talecris Inc. to Talecris GmbH and then to PEI; (ii) The PEI fees will not be
charged to Rosia.

 

2.6           Payment. The
Parties shall pay the amount specified in invoices issued in accordance with
Section 2.2 above within forty-five (45) days of receipt thereof.

 

2.7           Payment Disputes.
All billing and payment disputes between the Parties shall be resolved in
accordance with Section 16.10 below.

 

2.8          [***]

 

ARTICLE 3

SUPPLY CHAIN COORDINATION

 

3.1           Forecasts. Starting
on the Commencement Date and then by the seventh day of each month during the
Term, Talecris GmbH shall deliver to Rosia a twelve (12) month rolling forecast
of required Finished Products for supply to Talecris GmbH. The required 

 

***CONFIDENTIAL TREATMENT REQUESTED

 

8

Finished Products identified for the first
three (3) months shall be considered to be firm orders (“Binding Forecast”)
and, upon acceptance of such Binding Forecast, Rosia shall be obligated to
purchase from Talecris GmbH the quantity of Contractual Products required to
meet those orders, and Talecris GmbH shall be obligated to purchase from Rosia
the quantity of Finished Products, identified in the Binding Forecast. Rosia
shall have no obligation to purchase any Contractual Products in amounts
greater than required in the forecast; provided, however, Rosia will
agree to work with Talecris GmbH in a commercially reasonably manner to permit
Talecris GmbH to meet orders in excess of the Binding Forecast.

 

3.2           Delivery of
Finished Products. Rosia shall use commercially reasonable efforts to
deliver Finished Products in a timely manner consistent with Talecris GmbH’s
purchase orders that are sent to Rosia two months before delivery month.

 

ARTICLE 4

PRODUCTS

 

4.1           Purchase Orders.
Upon acceptance of Talecris GmbH’s first forecast set forth in Article 3 above,
Rosia shall deliver to Talecris GmbH a purchase order for Contractual Products
in the total aggregate quantities set forth in the Binding Forecast approved by
both Parties as set forth in Article 3 above. Thereafter, Rosia shall deliver
purchase orders for Contractual Products reflecting the aggregate quantities
order for the third month in the Binding Forecast (in each case, a “Purchase
Order”). Talecris GmbH shall issue Purchase Orders in a similar manner for
Finished Products upon delivery of each Binding Forecast. Each Purchase Order
shall specify the quantity of the Contractual Products ordered and delivery
date consistent with normal lot sizes and consistent with past practice.

 

4.2           Shipments. Each
Party shall be responsible for making the necessary shipping arrangements for
their respective Products in conformance with the delivery dates set forth in
the Purchase Orders provided by the other Party. All shipments of Products
shall contain the applicable certificate of batch release and the risk of loss
shall be determined in accordance with the provisions of Section 9.2 below.

 

4.3           Specification.
Talecris GmbH shall, and to the extent appropriate, ensure that Talecris Inc.
shall, manufacture, process, store, distribute, transport, dispose, package,
inspect, test and otherwise handle, and Rosia shall store, package, inspect,
test, transport, dispose and otherwise handle, Contractual Products and
Finished Products, as applicable to their activities under this Agreement
respectively, at all times in compliance with current Good Manufacturing
Practices (“cGMPs”) and other applicable Regulations (as defined in Section 7.1
below), the specifications listed in Exhibit 6, and incorporated herein by
reference (the “Specifications”), the ED Dossier/registration formulae, the
European registrations listed on Exhibit 7 (“European Registrations”), applicable
SOPs (as defined in Section 7.2), and the Agreement on the Manufacture under
Contract between Talecris Biotherapeutics GmbH and Bayer Biologicals S.r.1.
effective as of the date of signing attached as Exhibit 8(A) and following
Talecris GmbH’s qualification as 

 

9

releaser, the Agreement on the Manufacture
Under Contract attached as Exhibit 8(B). Both such Agreements are referred to
in this Agreement as the “Manufacture Under Contract Agreement”. The initial
Specifications shall be the same as in effect as of the Commencement Date. Talecris
GmbH and Rosia shall not make any changes to the Specifications or the SOPs
without the prior written approval of the other Party, such approval not to be
unreasonably withheld. All Parties shall maintain all records as are necessary
and appropriate to demonstrate compliance with cGMPs, the Specifications, the
SOPs and Regulations. Any change by one Party to the Specifications or SOP’s
that could required a European regulatory submission or affect the available
supply of Contractual Products or Finished Products should be communicated in
writing to the other Party with copies sent to the following:

 

For Rosia:

 

	
  Head of QA/QC

  	
   

  	
  Dr. Joachim Leube

  	
   

  	
  +39 0577 571 205 

  +39 02 3978 4278 (Fax) 

  joachim.leube.jl@bayer-ag.de

  
	
  Regulatory Affairs

  	
   

  	
  Dr. Pasqualina Zammarrelli

  	
   

  	
  +39 0577 571 204 

  +39 02 3978 5906 (Fax) 

  pasqualina.zammarrelli.pz@bayer-ag.de

  

 

For Talecris
GmbH:

 

	
  Head of Quality Assurance

  	
   

  	
  Dr. Cordula Schneider

  	
   

  	
  +49 69-660 593-391 

  +49 69-660 593-110 (Fax) 

  cordula.schneider@talecris.com

  
	
  Head of Regulatory Affairs

  	
   

  	
  Dr. Wolfgang Schulten

  	
   

  	
  +49 69-660 593-401 

  +49 69-660 593-110 (Fax) 

  wolfgang.schulten@talecris.com

  

 

For Talecris,
Inc.

 

Talecris
Biotherapeutics, Inc.

Attn:  Anne Davis

8368 US 70
West

Clayton NC
27520

Phone:  1-919-359-7268

Email:
anne.davis@talecris.com

 

4.4           Acceptance and
Rejection. Subject to the rest of this Section 4.4, Rosia and Talecris GmbH
shall each have a period of sixty (60) days from the date of its receipt of a
shipment of Contractual Products or, as appropriate, Finished Product (the “Inspection
Period”) to inspect the delivered Contractual Products or Finished Products and
reject the corresponding shipment of Contractual Products or Finished Products
for nonconformity 

 

10

with the Specifications. If Rosia or, as
appropriate, Talecris GmbH, rejects such shipment or a portion thereof, it
shall promptly so notify the other Party, such rejected Contractually Products
or Finished Products shall be considered Nonconforming Products and the
provisions of Section 12.1 below shall apply. If after accepting a shipment of
the Contractual Products or Finished Products, Rosia or, in the case of
Finished Products, Talecris GmbH, subsequently discovers latent material
defects (including without limitation, nonconformance to the Specifications)
not reasonably discoverable during the Inspection Period, Rosia or Talecris
GmbH may revoke its acceptance of such shipment of the Contractual Products or
a portion thereof, or Finished Products or a portion thereof, by giving written
notice and disclosing the nature of any defects to Talecris GmbH or Rosia as
soon as practicable after discovering such defects. In such event, such
rejected Contractual Products or Finished Products shall be considered
Nonconforming Products to the extent such latent material defects in fact are
present and the provisions of Section 12.1 below shall apply.

 

4.5           Title. Title
to the Contractual Products will be deemed to pass to Rosia upon delivery to
Rosia by the common carrier at the Rosia facility in Rosia, Italy. In the event
that Rosia revokes its acceptance of any Contractual Products, title will
revert to Talecris GmbH. Title to Finished Products will be deemed to pass to
Talecris GmbH upon delivery to Talecris GmbH’s carrier at Rosia’s facility. In
the event that Talecris GmbH revokes its acceptance of any Finished Products,
title will revert to Rosia.

 

ARTICLE 5

MANUFACTURING REQUIREMENTS

 

5.1           Manufacturing
Procedures. If Rosia’s approval of Talecris Inc.’s manufacturing procedures
is required under applicable Regulations, Talecris GmbH shall provide Rosia
with a copy of the ED Dossier/registration that provides a detailed overview of
the manufacturing processes that have been implemented by Talecris Inc. Talecris
GmbH shall ensure that Talecris Inc. cooperates and provides reasonable
assistance to Rosia to facilitate Rosia’s compliance with all applicable
Regulations, including without limitation, those specified in E.D. directive
91/356, article 12, as may be amended from time to time, and any successor
directive thereto. Any change by one Party to the manufacturing procedures that
could require a European regulatory submission or affect the available supply
of Contractual Products or Finished Products should be communicated in writing
to the other Party with copies sent to the following:

 

For Rosia:

 

	
  Head of QA/QC

  	
   

  	
  Dr. Joachim Leube

  	
   

  	
  +39 0577 571 205 

  +39 02 3978 4278 (Fax) 

  joachim.leube.jl@bayer-ag.de

  
	
  Regulatory Affairs

  	
   

  	
  Dr. Pasqualina Zammarrelli

  	
   

  	
  +39 0577 571 204 

  +39 02 3978 5906 (Fax) 

  pasqualina.zammarrelli.pz@bayer-ag.de

  

 

For Talecris
Gmbh:

 

11

 

	
  Head of Quality Assurance

  	
   

  	
  Dr. Cordula Schneider

  	
   

  	
  +49 69-660 593-391 

  +49 69-660 593-110 (Fax) 

  cordula.schneider@talecris.com

  
	
  Head of Regulatory Affairs

  	
   

  	
  Dr. Wolfgang Schulten

  	
   

  	
  +49 69-660 593-401 

  +49 69-660 593-110 (Fax) 

  wolfgang.schulten@talecris.com

  

 

For Talecris,
Inc.

 

Talecris
Biotherapeutics, Inc.

Attn: Anne
Davis

8368 US 70
West

Clayton NC
27520

Phone:
1-919-359-7268

Email:
anne.davis@talecris.com

 

5.2           Revisions to
Manufacturing Procedures. If the Manufacturing procedures require changes
for any reason, they shall be revised in accordance with the Clayton Critical
Change procedures in effect on the Commencement Date or from time to time
thereafter, which shall be made available to Rosia for inspection at the
Clayton Facility upon request by Rosia. Talecris GmbH shall obtain Rosia’s approval,
which approval shall not be unreasonably withheld, prior to making any change
to Manufacturing procedures (including the Clayton Critical Change procedures)
that may affect any European Registrations. If such changes require that Rosia
incur expense or cost in order to comply with the requirement of this
Agreement, Talecris GmbH will reimburse Rosia such expense and cost.

 

5.3           Revisions to
Manufacturing Processes. If a Manufacturing process is changed, then the
new process shall be revalidated as required by the Clayton Critical Change
procedures in effect on the Commencement Date or from time to time thereafter,
with due regard to any critical parameters and documented according to the
Clayton Critical Change procedures then in effect, which shall contain details
of the place, extent and cost of the validation. If such changes require that
Rosia incur expense or cost to comply with the requirements of this Agreement
Talecris GmbH will reimburse Rosia such expense and cost.

 

5.4           Batch Records.
Talecris GmbH shall provide to Rosia a written report for each production batch
(each a “Manufacturing Record”) for
the purpose of complying with the registration and the documentation
requirements of applicable Regulations, including without limitation, ED GMP Guidelines
and of ED directive 91/356 article 9, as each may be amended from time to time,
and any successors thereto.

 

5.5           Batch Sizes. Batch
sizes shall be determined by Talecris GmbH based on process validation. Talecris
Inc. shall ensure that it manufacturers only validated batch sizes.

 

12

5.6           Deviation Report.

 

(i)            If
during the Manufacture of the Contractual Products by Talecris Inc. these
arises a result that is classified as either a Type I Incident or a Type II
Incident, then Talecris GmbH shall ensure that Talecris Inc. prepares within
seven (7) days following the discovery of such deviation a written report
detailing such deviation (a “Deviation Report”)
and promptly send to Rosia such Deviation Report prior to Talecris GmbH’s
delivery of the Contractual Products which are the subject of such report. If
Rosia rejects shipment of the Contractual Products based on a Deviation Report,
it shall promptly notify Talecris GmbH, such Contractual Products shall be
considered Nonconforming Products and the provisions of Section 12.1 shall
apply. For purposes of this Agreement, a “Type I Incident”
shall be defined as an unexpected result that has potential serious impact on
product safety, identity, strength, quality, purity, efficacy or
manufacturing/testing process. Examples of Type I Incidents include final
product sterility and stability failure, media fill failure, pyrogen
specification exceeded for bulk or final container and inadequate viral
inactivation process. For purposes of this Agreement, a “Type II
Incident” shall be defined as an unexpected result that has the
potential to affect product safety, identity, strength, quality, purity,
efficacy, or manufacturing/testing process performance. Examples of Type II
Incidents include clean steam exceeding action level for LAL and Pre sterile
in-process bioburden exceeding action level.

 

(ii)           If
during the processing, storage, distribution, testing, transport, disposal or
other handling, as applicable, of the Contractual Products by Rosia there
arises a result that is classified as either a Type I Incident or a Type II
Incident, then Rosia shall prepare within seven (7) days following the
discovery of such deviation a Deviation Report and promptly send to Talecris
GmbH such Deviation Report. As necessary to the extent the deviations and
incidents are due to the acts or omissions of Rosia, or its Affiliates acting
in furtherance of Rosia’s performance under this Agreement, Rosia will be
responsible, at no cost to Talecris GmbH, to implement the necessary corrective
action for such Type I or Type II Incidents, including the destruction of
Product if required.

 

5.7           Records. Both
Parties shall maintain production records and other records required by the ED
Dossier/registration formulae, European Registrations, Specification, SOPs,
cGMPs or Regulations. Each Party shall make such records available to the other
Party for inspection following a written request by the other Party; such
request shall not be unreasonably denied.

 

ARTICLE 6

QUALITY ASSURANCE

 

6.1           Quality Assurance.
The Parties shall perform their obligations in accordance with the Manufacture
Under Contract Agreement attached hereto as Exhibit
8A, or, as applicable, Exhibit 8B.
Exhibit 8A shall become effective on the Commencement Date and be valid through
December 31, 2007. Provide Talecris has obtained qualification as releaser
of the Finished Products under European applicable law from the competent
Regulatory Authorities by January 1, 2008, then on or before
January 1, 2008 Rosia shall sign a new Manufacturer Under Contract
Agreement attached Exhibit 8B
setting forth its reduced 

 

13

obligations with regards to final release of
Finished Product to the various marketing authorities. The Pharmaceutical
Duties and Responsibilities are defined in Appendix 3 of the Manufacture Under
Contract Agreement(s).

 

6.2           Testing. The
Parties shall conduct all testing of Contractual and Finished Products as
applicable in accordance with test procedures in effect as of the Commencement
Date (as may be amended from time to time) and all applicable Regulations and
Registrations. To the extent required by applicable Regulations, Rosia and
Talecris GmbH shall approve such test procedures. Talecris GmbH shall provide
Rosia with the test results for lots of Contractual Product tendered to Rosia
for acceptance or rejection pursuant to Section 4.4 and Rosia shall do the same
for Talecris GmbH with respect to Finished Products tendered. The Parties shall
act in a commercially reasonable manner in considering and adopting new test
procedures consistent with the prevailing state of scientific knowledge and
suitable for quality assessment.

 

6.3           Labeling and
Documentation.

 

(i)            Rosia
acknowledges and agrees that all right, title and interest in and to the
Talecris GmbH’s registered trademarks and related goodwill included in Talecris
GmbH’s trademarks, and all registrations of such Talecris GmbH trademarks, are
reserved to and belong exclusively to Talecris GmbH. All goodwill deriving from
the use of Talecris GmbH’s trademarks by Rosia pursuant to the terms of this
Agreement or arising out of this Agreement shall accrue solely and exclusively
to Talecris GmbH.

 

(ii)           Rosia
shall not challenge the validity of Talecris Inc.’s registered trademarks or
Talecris Inc.’s ownership thereof in any form or manner. Rosia shall not at any
time during or after the term of this Agreement, (a) knowingly use any of
Talecris Inc.’s trademarks in any way that would impair the validity of such
Talecris Inc. trademark as a proprietary trademark, service mark, trade name
and/or trade dress in any jurisdiction, (b) knowingly take any action which
would impair Talecris Inc.’s ownership of any of Talecris Inc.’s trademarks or
their legality or enforceability, (c) register, or cause to be registered, in
Rosia’s name or the name of another, any of Talecris Inc.’s trademarks or any
other trademarks, names, logos, color schemes, symbols, trade dress or designs
it knows to be confusingly similar to Talecris Inc.’s registered trademarks,(d) use,
display, advertise or promote any trademarks, names, logos, color schemes,
symbols trade dress or designs it knows to be confusingly similar to any of
Talecris Inc.’s registered trademarks in any jurisdiction, or (e) use any of
Talecris Inc.’s registered trademarks as part of a corporate or trade name of
any business organization.

 

(iii)          Rosia
shall submit to Talecris GmbH for its written approval before any use is made
thereof a reasonable number of samples of any packaging or labeling or other
materials produced, printed or manufactured by Rosia or its affiliates and on
which Talecris GmbH’s trademarks appear. Rosia shall label and package the
Finished Products in accordance with Talecris GmbH’s labeling, packaging and
quality standards set forth on Exhibit 9
attached hereto and incorporated hereto and incorporated herein by reference. All
packaging and labeling used by Rosia for the Finished Products shall bear such
packaging and labeling approved by Talecris GmbH, provided however that Rosia
will not be obligated to use such packaging and labeling approved by Talecris
GmbH where Rosia has a good faith belief that such use would violate Applicable
Law.

 

14

ARTICLE 7

REGULATORY REQUIREMENTS

 

7.1           Compliance with
Regulations. Talecris GmbH shall comply, and shall ensure that Talecris
Inc. complies, in all material respects with all laws, requirements,
regulations, registrations, guidelines, licenses and directives, including
those in any Regulatory Approval of any Regulatory Authority (including without
limitation, applicable cGMPs as defined in national and international accepted
GMP compendia including PIC/C and WHO GMP Guide) including all specifications
and procedures for plasma sourcing, plasma testing, and in process testing and
all regulations, specifications, and procedures contained therein, including,
without limitation, the regulations, the regulations set forth in Exhibit 10 (collectively, “Regulations”). Likewise, Rosia shall
comply in all material respects with Regulations applicable to the performance
of its obligations hereunder. Each Party shall comply with all Regulations that
become applicable to such Party effective after the Effective Date within the
timeframe required by such Regulation or applicable Regulatory Authority,
provided that the Parties will allocate the costs and expenses of any such
compliance on an equitable basis, taking into account the respective economic
benefit of this arrangement, and the remaining duration of this Agreement. Each
Party shall maintain all government approvals, permits and licenses necessary
or desirable in the performance of their respective obligations under this
Agreement. “Regulatory Approvals” shall
mean all licenses, approvals, permissions, or consents required for the
manufacture, processing, inspection, testing, packaging, storage, transport,
distribution or sale of the Contractual Products or Finished Products. “Regulatory Authority and Regulatory Authorities” shall mean
the U.S. Food and Drug Administration, the German Health Authority and any
successor agencies and all other local, state, federal, or foreign governmental
authorities with authority to grant or deny the necessary Regulatory Approvals
or to regulate the manner or means by which the Contractual Products or
Finished Products are manufactured, processed, tested, inspected, packaged,
stored, transported, distributed, or sold.

 

7.2           Inspection of
Facilities. Each Party shall have the right, on reasonable written advance
notice (to the extent practicable, not less than one (1) week advance notice),
and during normal business hours, to inspect and audit the other Party’s
facilities (including the Clayton Facility), standard operating procedures (as
in effect as of the Effective Date and amended from time to time upon mutual
agreement of the Parties, and any replacement or successor thereof, “SOPs”), operations, testing, storage and books and records
to confirm compliance with Section 7.1 and the other Party’s compliance with
the terms and conditions of this Agreement, provided that what is being
inspected is relevant to the Contractual Products or Finished Products, as
applicable, and that such inspection does not unreasonably interfere with the
conduct of business of such other Party. Each Party shall use its commercially
reasonable efforts to accommodate any reasonable request made by the other
Party to inspect such facility. Each Party shall respond in writing to the
other Party regarding any items of noncompliance identified by the other Party
during such inspections or audits within fifteen (15) days of the other Party’s
notice thereof, and each Party shall develop a plan, reasonably satisfactory to
such other Party, to remedy 

 

15

any such items of noncompliance as soon as
practicable but in no event later than sixty (60) days of notice thereof, and
shall remedy such items of noncompliance as set forth in such plan, the failure
of which shall entitle the other Party to terminate this Agreement in
accordance with Section 13.2 hereof.

 

7.3           Regulatory
Filings. Each Party shall promptly accommodate all requests made by any
Regulatory Authority to audit such Party’s facilities that relate to the
Contractual Products or Finished Products, as the case may be. Both Parties
shall have the right to review, during the Term and for five (5) years
thereafter, all audit findings or notices of Regulatory Authorities as such
may, directly or indirectly, bear upon each Party’s obligations under this
Agreement. Each Party shall develop and provide to the other Party a plan,
reasonably satisfactory to the other Party, to remedy, and shall remedy, any
deficiencies identified as a result of such regulatory inspection in the time
frames mandated in the applicable inspection report or the applicable
Regulations. Each Party shall promptly notify the other Party (i) at the time
such Party becomes aware of any Regulatory Authority inspection of its facility
(including the Clayton Facility) and (ii) at the time such Party receives
notice from the Regulatory Authority of any observation or regulatory action,
such as a warning letter. Each Party shall promptly provide a copy of any audit
finding with such Party’s corrective action response to the other Party for
items that relate to the Contractual Products or Finished Products, as the case
may be.

 

7.4           Regulatory
Approvals. Talecris GmbH is solely responsible for obtaining all necessary
Regulatory Approvals, including Approvals by the European Regulatory
Authorities, to sell Contractual Products to Rosia and Finished Products in
Europe. Rosia shall upon request, at Talecris GmbH’s sole cost and expense, and
as reasonably necessary, provide Talecris GmbH with all information, including
but not limited to dossier, technical information and other information and
other information for obtaining Regulatory Approval in Europe. Rosia is solely
responsible for obtaining all necessary Regulatory Approvals, including by the
European Regulatory Authorities, to, test, package and release any Finished
Product to Talecris GmbH in Europe. Talecris GmbH shall upon request, at Rosia’s
sole cost and expense, and as reasonably necessary, provide Rosia with all
information, including but not limited to dossier, technical information and
other information for obtaining such Regulatory Approvals in Europe.

 

ARTICLE 8

DOCUMENTATION AND RESERVE SAMPLES

 

Each Party
shall maintain such reserve samples of product and packaging materials as
required by the Quality Assurance Standards attached as Exhibit 8.
Talecris GmbH shall provide to Rosia (at no cost to Rosia) sufficient
quantities of Contractual Products to permit Rosia to meet the Regulations for
reserve samples and packaging.

 

16

 

ARTICLE 9

RISK OF LOSS

 

9.1           Storage. Until
a Finished Product has been released by Rosia in accordance with applicable
Regulations, including but not limited to EU directive 91/356, article 21 (as
may be amended from time to time, and any successor thereto), storage shall be
subject to quarantine.

 

9.2           Risk of Loss.
Risk of loss for Contractual Product in transit to Rosia shall lie with
Talecris GmbH. The risk of loss for the Contractual Product due to casualty,
spoliage, loss, theft, fire, damage or destruction after the shipment of the
Contractual Product is delivered to Rosia by the common carrier at the Rosia
facility in Rosia, Italy shall be borne by Rosia. The risk of loss for Finished
Products shall pass to Talecris GmbH on delivery from Rosia to Talecris GmbH’s
carrier at Rosia’s facility.

 

ARTICLE 10

CONFIDENTIALITY

 

10.1         General. All
information provided by one Party to the other Party in connection with this
Agreement (including, without limitation, the Specifications and forecasts)
shall be maintained in strict confidence by the receiving Party being shared
only with affiliated companies, consultants, attorneys, and employees with a
need to know and who are bound by similar obligations of confidentiality. Such
information shall remain the property of the providing Party, and the receiving
Party shall not make use of any such information except for the purposes for
which it was provided. Provided, however, that such information may also be
shared with creditors, potential investors, or collaborators who have a need to
know and who are bound to maintain the confidentiality of such information. At
the termination of this Agreement, the receiving Party shall promptly return to
the providing Party any physical embodiments (including copies) of any such
information. Each Party agrees to keep confidential the existence of this
Agreement, as well as all of its terms and conditions; provided that if a
public announcement or disclosure is required by law, rule, regulation, court
order, subpoena, interrogatory or other discovery request (including without
limitation applicable securities laws or stock exchange regulations), and
subject to Section 10.2(v), the Party required to make the public announcement
or disclosure shall be permitted to make such disclosure and shall provide
prompt prior written notice of such requirement to the other Party, and the
Parties shall thereafter negotiate in good faith, to the extent appropriate and
feasible, the contents of the public announcement or disclosure.

 

10.2         Exceptions. The
covenants of the receiving Party contained in Section 10.1 shall not apply to
information which:  (i) is already in the
public domain at the time of disclosure; (ii) becomes part of the public domain
at the time of disclosure; (ii) becomes part of the public domain through no
action or omission of the receiving Party after disclosure to the receiving
Party; (iii) is already known to the receiving Party on a non-confidential
basis at the time of disclosure, as evidenced by the receiving Party’s written
records; (iv) has been or is disclosed to the receiving Party in good faith by
a third party who was or is not, at the time of disclosure, under any
obligation of confidence to 

 

17

the other Party hereto at the time the third
party disclosed such information; or (v) is required to be disclosed by law,
provided that the receiving Party shall cooperate with the disclosing Party (at
the disclosing Party’s expense) in obtaining any available protection for such
information to be disclosed.

 

ARTICLE 11

INDEMNITY AND INSURANCE

 

11.1         Indemnity. Talecris
GmbH hereby agrees to save, defend and hold Rosia and its affiliates and its
and their directors, officers, manages, employees, representatives,
consultants, stockholders, controlling persons and agents and each of the
heirs, executors, successors and assigns of any of the foregoing (together, the
“Rosia Group”) harmless from and
against any and all claims, suits, actions, liabilities, expenses and/or
losses, including punitive or exemplary damages and reasonable attorney’s fees
and expenses (“Claims”) asserted by a person
or entity other than a member of the Rosia Group arising from any material
breach of obligations under this Agreement by the Talecris GmbH Group (as
defined below), and/or the manufacture, use, development, marketing, sale,
commercialization, import, export, or offer the sale of Contractual Products
and/or Finished Products by Talecris GmbH, Talecris, Inc. or any third party,
except to the extent that Rosia is obligated to indemnify Talecris GmbH as
expressly stated in this Section 11.1. Rosia hereby agrees to save, defend and
hold Talecris GmbH and its affiliates and its and their directors, officers,
managers, employees, representatives, consultants, stockholders, controlling
persons and agents and each of the heirs, executors, successors and assigns of
any of the foregoing (together, the “Talecris GmbH Group”)
harmless from and against any and all Claims asserted by a person or entity
other than a member of the Talecris GmbH Group arising from any material breach
by Rosia of Section 7.1 of this Agreement.

 

11.2         Indemnification
Process. Each party indemnified under the provisions of this Agreement,
upon receipt of written notice of any Claim or the service of a summons or
other initial legal process upon it in any action instituted against it for
which it may be entitled to indemnification pursuant to this Agreement, shall
promptly give written notice of such Claim, or the commencement of such action,
or threat thereof, to the Party from whom indemnity shall be sought hereunder,
provided, however, that the 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 if prejudiced
by such failure. Each indemnifying party shall be entitled as its own expense
to participate in the defense of such Claim or action, or, if it shall elect,
so long as it has acknowledged in writing to the indemnified party its
indemnification obligations hereunder, by written notice to the indemnified
party within twenty (20) days of receipt of notice of the Claim or action from
the indemnified party to assume such defense, in which event such defense shall
be conducted by counsel chosen by such indemnifying party (without prejudice to
the right of the indemnified party to fully participate at its own expense
through counsel of its own choosing) which counsel may be any counsel
reasonably satisfactory to the indemnified party against whom such Claim is
asserted or who shall be the defendant in such action, and such indemnified
party shall bear all fees and expenses of any additional counsel retained by it
or them, provided that the indemnifying party shall obtain the 

 

18

consent of the indemnified party (which
consent may be withheld in its sole discretion) before entering into any
settlement, adjustment or compromise of such Claims, provided further that the
indemnifying party may, without the consent of the indemnified party, settle or
compromise or consent to the entry of any judgment in any Claim or action
involving only the payment of money which includes as an unconditional term
thereof the delivery by the claimant or plaintiff to the indemnified party of a
duly executed written release of the indemnified party from all liability in
respect of such Claim or action which written release shall be reasonably
satisfactory in form and substance to the indemnified party. Notwithstanding
the immediately preceding sentence, if the named parties in such action
(including impleaded parties) include the indemnified and the indemnifying
parties, and the indemnified party shall have been advised by counsel that
there may be a conflict between the positions of the indemnifying party and the
indemnified party in conducting the defense of such action or that there are
legal defenses available to such indemnified party materially different from or
in addition to those available to the indemnifying party, then counsel for the
indemnified party, shall be entitled, if the indemnified party so elects, to
conduct the defense and, in such event, the reasonable fees and expenses of
such counsel shall be borne by the indemnifying party. If the indemnifying
party shall elect not to assume the defense of such Claim or action, such
indemnifying party shall reimburse such indemnified party for the reasonable
fees and expenses of any counsel retained by it, and shall be bound by the
results obtained by the indemnified party in respect of such Claim or action;
provided, however, that no such Claim or action shall be settled without the
written consent of the indemnifying party (which consent shall not be unreasonably
withheld or delayed).

 

11.3         Insurance. During
the Term (as defined below) of this Agreement and for a period of five (5)
years following the expiration or earlier termination of this Agreement, each
Party shall maintain, at its sole cost and expense, general liability insurance
including product liability coverage, with bodily injury, death and property
damage limits, in such amounts and with such scope of coverage as is consistent
with plasma industry standards and all applicable laws reulgations.

 

In addition to the
requirements set forth above, the following insurance coverage shall be
maintained by Rosia for the protection of Products:

 

(i)            All-risk
Property Policy, including flood and earthquake, to be maintained continuously
while Products are located in Rosia’s facility. Property insurance limits of no
less than ten million Euros (€10,000,000) each occurrence; and

 

(ii)           All-Risk
Cargo insurance with limits of no less than five million Euros (€5,000,000)
each occurrence.

 

11.4         Insurance
Recoveries. If and to the extent the indemnifying party has acquired
insurance in compliance with Section 11.3, and to the extent such coverage is
inadequate to cover all Claims asserted against Talecris GmbH and Rosia and if
and to the extent Talecris GmbH or Rosia, as the case may be, has its own
policy of insurance purporting to provide coverage for Claims against Talecris
GmbH or Rosia, as the case may be, Talecris GmbH or Rosia, as 

 

19

the case may be, shall not be entitled to
indemnification from the indemnifying party for such Claims under Section 11.1
until Talecris GmbH or Rosia, as the case may be, has utilized all commercially
reasonable means to recover such loss under its policy of insurance.

 

11.5         Limitation of
Damages. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED HEREIN, AND WITHOUT
LIMITING EITHER PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 11.1, NO
PARTY SHALL BE LIABLE TO THE OTHER PARTY UNDER THIS AGREEMENT FOR ANY SPECIAL,
CONSEQUENTIAL, INCIDENTAL OR INDIRECT LOSSES (INCLUDING LOSS OF PROFITS OR
LIQUIDATED DAMAGES) ATTRIBUTABLE TO ITS PERFORMANCE UNDER THIS AGREEMENT OR TO
ANY OTHER MATTER ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT.

 

ARTICLE 12

NONCONFORMING PRODUCT AND RECALLS

 

12.1         Nonconforming
Product. In the event that Taleris GmbH provides Contractual Products or
Rosia provides Finished Product that do not meet the ED Dossier/registration
formulae, European Registrations or Regulations, do not conform to the
Specifications, contain latent defects, or have not been manufactured in
accordance with the EU Dossier/registration formulae, European Registrations,
Specifications, SOPs, cGMPs or Regulations (“Nonconforming
Product”), then the breaching Party will at no cost to the
other, and as soon as reasonably feasible, replace such Nonconforming Product
with an equivalent amount of conforming Contractual or Finished Product as
applicable. Either Party at the option of the other, shall destroy all
Nonconforming Product and promptly provide a certificate of destruction, or
return such Nonconforming Product. The breaching Party shall reimburse the
other for the reasonable direct costs incurred by the other related to the
destruction or return of such Nonconforming Product. Talecris GmbH shall
provide Rosia with the lot number and plasma unit identification number of any
Nonconforming Product delivered to Rosia.

 

12.2         General
Requirements. Rosia shall maintain accurate records of the quantities of
the Contractual Products received and Talecris GmbH shall do the same for Finished
Product received.

 

12.3         Distribution and
Use Records. Talecris GmbH maintain and give Rosia access, upon advance
notice and at reasonable times, to, for a period of not less than thirty (30)
years from production, donor records and test results with respect to each unit
of plasma included in the Contractual Products delivered to Rosia. Such records
and results shall be maintained in a manner that assures that they can rapidly
and unequivocally be accounted for and made available to Rosia no later than
fourteen (14) days from the date of request. Rosia shall maintain and give
Talecris GmbH access, upon advance notice and at reasonable times, to, for a
period of not less than thirty (30) years from the date of delivery, records
identifying the use of Contractual Products and sale to Talecris GmbH of the
Finished Products. Such records and results shall be maintained in a manner
that assures that they can rapidly and unequivocally be accounted for and made
available to Talecris GmbH no later than fourteen (14) days from the date of
request. Rosia shall assist Talecris GmbH in identifying, tracking and
controlling the use of any Contractual 

 

20

Products identified in post donation
information as contaminated or otherwise unsuitable for use. Notwithstanding
the foregoing, neither Party will destroy any such records and results without
first notifying the other Party.

 

12.4         Adverse Events.
Each Party shall record and investigate all reports of adverse events in which
the Contractual Products or the Finished Products have been implicated. If
either Party determines that the Contractual Products or the Finished Products
have caused adverse reactions, such Party shall immediately notify the
applicable Regulatory Authority as required by the Regulations, and shall
promptly notify the other Party. Each Party shall promptly notify the other of
any adverse event resulting in a market withdrawal or recall. The Parties shall
comply with Exhibit 11, as may be amended from
time to time, to assure the effective and efficient exchange of information
relating to safety matters.

 

12.5         Customer
Notification of Adverse Reactions. In the event that during the course of a
preliminary investigation related to a report of any adverse reaction
associated with any Contractual Product or Finished Product Talecris GmbH or
Rosia obtains preliminary evidence indicating that any Contractual Product or
Finished Product may have caused such specific adverse reaction, each Talecris
GmbH customer that received any such Contractual Product or Finished Product
shall be notified by Talecris GmbH and cautioned that any unused containers of
the suspect lots should be withheld from use, pending the outcome of more
definitive investigations and evaluations, with a copy of such notice to the
applicable Regulatory Authority if required. Talecris GmbH shall promptly
provide Rosia with a copy of such notice. Any and all of the foregoing actions
will be executed with the concurrence of the appropriate Regulatory
Authorities, to the extent required by Applicable Law (as defined below).

 

12.6         Withdrawals and
Recalls. Talecris GmbH shall make all contacts with the relevant Regulatory
Authorities and shall be responsible, at its sole cost and expense (except
where the recall is due to the negligence or willful default of Rosia), for
coordinating all activities in connection with any recall or withdrawal of any
Contractual or Finished Product. In the event that Rosia believes a recall or
withdrawal of a Contractual or Finished Product may be necessary or
appropriate, Rosia shall immediately notify Talecris GmbH in writing. In the
event that Talecris GmbH initiates a recall or withdrawal of a Contracutal or
Finished Product, Talecris GmbH shall so notify Rosia. Notwithstanding the
above, while Rosia remains the releaser of Finished Product:

 

(a)           if Rosia makes a determination that a
recall of a Contractual or Finished Product is necessary but Talecris GmbH
disagrees with such determination, Rosia may initiate a joint discussion by the
Parties of such issue with a mutually agreeable independent consultant and if
such consultant advises the Parties that it believes there should be a recall,
the Parties shall voluntarily implement a recall of the Contractual or Finished
Product;

 

(b)           if Rosia makes a determination that a
withdrawal of a Contractual or Finished Product is necessary for reasons of
safety and efficacy but Talecris GmbH disagrees with such determination, Rosia
shall have the right to discontinue its performance hereunder with respect to
such Contractual or Finished Product and all rights with respect to such
product, including, without limitation, under the licenses 

 

21

granted to Rosia under this Agreement with respect to
such product shall terminate and permanently revert to Talecris GmbH.

 

12.7         Complaints. Rosia
and Talecris GmbH will cooperate in the reporting, investigation and evaluation
of customer complaints, according to policies mutually determined by the Parties
in writing.

 

ARTICLE 13

TERM AND TERMINATION

 

13.1         Term. The term
of this Agreement (the “Term”)
shall commence as of the Effective Date and shall expire on December 31st,
2008 unless terminated early pursuant to this Article 13. Talecris GmbH may terminate
this Agreement without cause on serving notice of termination at least six (6)
months prior to the due date of termination. The modifications to the Rosia
Phase 1 Agreement become effective on the Commencement Date, and the wording of
this agreement will replace entirely the previous wording of the Rosia Phase I
Agreement.

 

13.2         Termination for
Cause. If either Party commits a substantial violation of the Agreement and
the other Party may, without prejudice to any other right or remedy, and after
giving the breaching Party sixty (60) days’ written notice of the breach,
terminate the Agreement. This Agreement shall not be so terminated if the
breaching Party  has cured the breach, or
submitted a plan for curing the breach reasonably acceptable to the non-breaching  Party within sixty (60) days after the
non-breaching Party’s notice. If the breaching Party fails to cure the breach
as set forth in the aforementioned plan and in accordance with the deadlines
set forth therein, the non-breaching Party may terminate this Agreement without
further notice. The non-breaching Party shall have the right to recover all
direct damages and losses arising as a result of any such material breach,
subject to the limitations contained in Section 11.5.

 

13.2.1      Rosia’s Right to Termination. If
Talecris fails to receive manufacturing authorization or otherwise is unable to
assume responsibility of release of Finished Product to the various Regulatory
Authorities, by January 1, 2008, then Rosia may treat such failure as a material
breach and terminate in accordance with Section 13.2.

 

13.3         Termination for
Force Majeure.

 

(i)            Talecris GmbH may terminate this
Agreement in its sole discretion upon thirty (30) days’ prior written notice in
the event of any failure or inability of Rosia to deliver Finished Products
hereunder due to Force Majeure extending beyond ninety (90) days. In the event
of termination under this Section 13.3(i), Rosia shall have no liability for
damages arising solely from such termination or otherwise excused by a Force
Majeure.

 

(ii)           Rosia may terminate this Agreement in
its sole discretion upon thirty (30) days’ prior written notice in the event of
any failure or inability of Talecris GmbH to provide Contractual Products
hereunder due to Force Majeure extending beyond ninety 

 

22

(90) days. In the event of termination under this
Section 13.3(ii), Talecris GmbH shall have no liability for damages arising
solely from such termination or otherwise excused by a Force Majeure.

 

13.4         Termination for
Insolvency. The Agreement may be terminated by Rosia, if Talecris GmbH, or
by Talecris GmbH, if Rosia:

 

(i)            admits
in writing that it is unable to pay its debts as they become due;

 

(ii)           starts
a proceeding, or indicates its acquiescence to a proceeding started by another,
relating to it under any bankruptcy, reorganization, rearrangement, insolvency,
readjustment of debt, dissolution, liquidation or similar law;

 

(iii)          makes
an assignment for the benefit of creditors;

 

(iv)          consents
to the appointment of a receiver, trustee or liquidator for a substantial part
of its property;

 

(v)           files,
or has filed against it, a petition in bankruptcy, reorganization,
rearrangement or insolvency which, if filed against it, is not dissolved or
dismissed within ninety (90) days after filing; or

 

(vi)          has
entered against it an order by a court of competent jurisdiction appointing a
receiver, trustee or liquidator for it or a substantial part of its property,
or approving its dissolution or termination, and if not consented to or
acquiesced in by such Party, such order is not vacated or set aside or stayed
within ninety (90) days.

 

Notwithstanding
anything to the contrary herein, no Party shall take or cause to be taken any
action relating to the voluntary liquidation or dissolution of such Party.

 

13.5         Effect of
Termination.

 

In the event
of termination of this Agreement the Parties shall cease all deliveries of
Products and performance of services. The Parties will prepare and submit final
invoices and the other Party shall pay such invoices in accordance with the
following:

 

(i)            Rosia
to pay any unpaid Transfer Price for Contractual Products in its care of
custody or in transit to Rosia;

 

(ii)           Talecris
to pay the Transfer Price for Finished Products which are subject to a Binding
Forecast in effect as of the date of termination, even if termination becomes
effective prior to the end of the period to which the Binding forecast relates
and Rosia to provide such Finished Product except to the extent not possible as
a result of Talecris’ early termination;

 

23

(iii)          Subject
to Section 2.5 above, Talecris to reimburse Rosia for the costs of any
packaging materials, water for injection (WFI) devices and medical devices
remaining unused at the termination of the Agreement, which were purchased by
Rosia for the processing of Contractual Products into Finished Products and
which reasonably reflect the forecasts provided by Talecris GmbH pursuant to
Section 3.1; and

 

(iv)          Each
Party shall promptly deliver to the other Party all books, records, and
confidential information owned by each Party and in the other Party’s
possession as of the termination date.

 

13.6         Remedies. The
rights of a Party to this Agreement to recover monetary damages from the other
Party to this Agreement with respect to termination of this Agreement are
exclusively set forth in this Article 13. Each Party shall have such
non-monetary rights and remedies provided under this Agreement or under law or
in equity for breaches of this Agreement, but only limited ot the remedy of
specific performance.

 

13.7         Special Assistance.
Prior to the termination of this Agreement and no later than the end of 2008,
Rosia agrees to use commercially reasonable efforts to provide Talecris GmbH or
any of its affiliates with information on regulatory requirements and license
information, regulatory trends, qualification status of Products, drug safety
studies on clinical trials, shipping and logistical information, packaging
requirements and practices used in the sale and distribution in Europe of the
Contractual Products and Finished Products. In addition, Rosia agrees to allow
Site visits by Talecris GmbH or any of its affiliates in order to gather “As-Is”
information and technical information on equipment.

 

Information
provided by Rosia shall include detailed process flows for the following:

 

(i)            Label
Development

 

(ii)           SAP
Master Data management

 

(iii)          Submission
of samples to PEI

 

(iv)          Stage
I/II Release of products

 

If Rosia’s
performance deteriorates, or material deficiencies or adverse trends are
discovered during (during site visit or otherwise) (“Performance
Deviaiton”). Rosia agrees to provide Talecris with assistance
and access reasonably necessary to correct the Performance Deviation. For
purposes of clarification, any delay in shipping product of more than fifteen
(15) days, or failing to ship at least eighty five percent (85%) of any
purchase order in saleable condition, shall be deemed a Performance Deviation.

 

ARTICLE 14

INTELLECTUAL PROPERTY

 

24

14.1         Intellectual
Property Rights. Talecris GmbH will obtain and maintain at its sole cost
and expense all third party intellectual property rights for the manufacture
and transport of Contractual Products and sale of Finished Products in Europe. Except
as set forth in Article 6 hereof, nothing in this Agreement shall act to grant
Rosia any rights or license to use any intellectual property of, or license by,
Talecris GmbH or Talecris Inc. Rosia agrees to maintain at its sole cost and
expense all licenses to third party intellectual property necessary or
appropriate for the testing, transport, storage, disposal and other handling of
the Contractual Products and Finished Products in Europe; provided, however,
such sole cost and expense shall be exclusively for those licenses which have
been granted to Rosia. Except as set forth in Article 6 hereof, nothing in this
Agreement shall act to grant Talecris GmbH or Talecris Inc. any rights or
license to use any intellectual property of, or licensed by, Rosia.

 

ARTICLE 15

REPRESENTATIONS AND WARRANTIES AND DISCLAIMER

 

15.1         Debarmemt. Each
Party certifies it will not, in connection with its obligations under this
Agreement, use in any capacity the services of any person, including any firm
or individual, that has been debarred or is subject to debarment under the
Generic Drug Enforcement Act of 1992, amending the Food Drug and Cosmetic Act
of 21 U.S.C. 335a (a) or (b), or any comparable requirement of any other
Regulation. Each Party agrees to notify the other Party promptly in the event
any person providing services to such Party under the scope of this Agreement
is debarred or becomes subject to debarment.

 

15.2         Compliance.

 

(i)            Rosia
represents and warrants that the distribution, inspection, transport, storage,
disposal and other handling of the Contractual Products and Finished Products
by Rosia shall (i) conform to applicable SOPs, the Specification, eGMPs and the
Regulations and (ii) be free from defects in material and workmanship and shall
not be adulterated or misbranded within the meaning of the applicable
Regulations.

 

(ii)           Talecris
GmbH represents and warrants on its own behalf and on behalf of Talecris, Inc.,
that the manufacture, processing, distribution, inspection, testing, transport,
storage, disposal and other handling of the Contractual Products by Talecris
GmbH and Talecris, Inc. shall (i) conform to applicable SOPs, the
Specifications, cGMPs and the Regulations and (ii) be free from defects in
materials and workmanship and shall not be adulterated or misbranded within the
meaning of the applicable Regulations.

 

15.3         Representations
and Warranties.

 

(a)           Rosia hereby represents and warrants
to Talecris GmbH that:

 

(i)            Due
Organization, Good Standing and Power. Rosia is a company duly organized,
validly existing and in good standing under the laws of Italy. Rosia has all
requisite corporate or other power and authority to own or lease and to operate
its assets and to conduct the business now being conducted by it. Rosia is duly
authorized, 

 

25

qualified or licensed to do business as a foreign
corporation or other organization in good standing in each of the jurisdictions
in which its ownership of property or the conduct of its business requires such
authorization, qualification or licensing, except where the failure to have
such authorization, qualification or licensing could not reasonably be expected
to have a material adverse effect on Rosia or on the consummation of the
transactions contemplated hereunder. Rosia has all requisite corporate power
and authority under Applicable Law and its Charter Documents to enter into this
Agreement and to perform its obligations hereunder and to consummate the
transactions contemplated hereby.

 

(ii)           Authorization
and Validity of Agreement. The execution and delivery of this Agreement by
Rosia and the consummation by it of the transactions contemplated hereby have
been duly authorized and approved by all necessary corporate action under
Applicable Law and the relevant Charter Documents on the part of Rosia and do
not require the approval of the stockholders of Rosia. This Agreement has been
duly executed and delivered by Rosia and constitutes the legal, valid and
binding obligation of Rosia enforceable against it in accordance with its
terms, except as that enforceability may be (i) limited by any applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the
enforcement of creditors’ rights generally, (ii) subject to general principles
of equity (regardless of whether that enforceability is considered in a
proceeding in equity or at law) and (iii) limited by general principles of
Applicable Law regarding the enforceability of arbitral awards and judicial
decisions.

 

(iii)          Lack
of Conflicts. Neither the execution and delivery of this Agreement by Rosia
or the consummation by it of the transactions contemplated hereby, does or will
(i) conflict with, or result in the breach of any provision of, the Charter
Documents of Rosia or (ii) violate any Applicable Law or any permit, order,
award, injunction, decree or judgment of any Governmental Authority applicable
to or binding upon Rosia or to which any of its properties or assets is
subject.

 

(iv)          No
Consents. The execution, delivery and performance of this Agreement by
Rosia and the consummation of the transactions contemplated by this Agreement
do not require any Governmental Approval. No consent (other than Governmental
Approvals) will be required to be obtained by Rosia for the consummation of the
transactions contemplated by this Agreement.

 

(b)           Talecris GmbH hereby represents and
warrants to Rosia that:

 

(i)            Due
Organization, Good Standing and Power. Talecirs GmbH is a corporation duly
organized, validly existing and in good standing under the laws of the state of
Delaware. Talecris GmbH has all requisite corporate or other power and
authority to own or lease and to operate its assets and to conduct the business
now being conducted by it. Talecris GmbH is duly authorized, qualified or
licensed to do business as a foreign corporation or other organization in good
standing in each of the jurisdictions in which its ownership of property or the
conduct of its business requires such authorization, qualification or
licensing, except where the failure to have such authorization, qualification
or licensing could not reasonably be expected to have a material adverse effect
on Talecris GmbH or on the consummation of the transactions contemplated 

 

26

hereunder. Talecris GmbH has all requisite corporate
power and authority under Applicable Law and its Charter Documents to enter
into this Agreement and to perform its obligations hereunder and to consummate
the transactions contemplated hereby.

 

(ii)           Authorization
and Validity of Agreement. The execution and delivery of this Agreement by
Talecris GmbH and the consummation by it of the transactions contemplated
hereby have been duly authorized and approved by all necessary corporate action
under Applicable Law and the relevant Charter Documents on the part of Talecris
GmbH and do not require the approval of the stockholders of Talecris GmbH. This
Agreement has been duly executed and delivered by Telecris GmbH and constitutes
the legal, valid and binding obligation of Talecris GmbH enforceable against it
in accordance with its terms, except as that enforceability may be (i) limited
by any applicable bankruptcy, insolvency, reorganization, moratorium or similar
laws affecting  the enforcement of
creditors’ rights generally, (ii) subject to general principles of equity
(regardless of whether that enforceability is considered in a proceeding in
equity or at law) and (iii) limited by general principles of Applicable Law
regarding the enforceability of arbitral awards and judicial decisions.

 

(iii)          Lack
of Conflicts. Neither the executions and delivery of this Agreement by
Talecris GmbH nor the consummation by it of the transactions contemplated
hereby, does or will (i) conflict with, or result in the breach of any
provision of, the Charter Documents of Talecris GmbH or (ii) violate any
Applicable Law or any permit, order, award, injunction, decree or judgment of
any Governmental Authority applicable to or binding upon Talecris GmbH or to
which any of its properties or assets is subject.

 

(iv)          No
Consents. The execution, delivery and performance of this Agreement by
Talecris GmbH and the consummation of the transactions contemplated by this Agreement
do not require any Governmental Approval. No consent (other than Governmental
Approvals) will be required to be obtained by Talecris GmbH for the
consummation of the transactions contemplated by this Agreement.

 

15.4         Disclaimer. NEITHER
PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OTHER THAN
THOSE EXPRESSLY MADE IN THIS AGREEMENT. ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED.

 

ARTICLE 16

MISCELLANEOUS

 

16.1         Governing Law.
Validity, construction and performance of this Agreement will be governed by
the laws of Italy regardless of the choice of law principles applicable in
Italy or in other jurisdictions. Application of the Aja Conventions on the
Uniform Law on the International Sale of Goods and on the Uniform Law in the
Formation of Contracts for the International Sale of Goods (both dated July 1st,
1964) and application of the UNICITRAL U.N. Agreement on the Sale of Goods
dated April 11th, 1980 are explicitly excluded.

 

27

16.2         Assignment. This
Agreement and all the provisions  hereof
shall be binding upon and inure to the benefit of the Parties hereto and their
respective successor and assigns, and it is not intended to confer upon any
other person any rights or remedies hereunder. Neither this Agreement nor any
of the rights, interests or obligations hereunder may be assigned by any of the
Parties without the prior written consent of the other Party hereto. Notwithstanding
the foregoing, Talecris GmbH may assign this Agreement and any or all rights or
obligations hereunder to (i) any affiliate of Talecris GmbH, (ii) any lender of
Talecris GmbH as collateral security or (iii) any successor in interest to
Talecris GmbH’s entire line of business to which the Agreement pertains
provided that any such successor becomes a party to this Agreement; provided
that no assignment under (i), (ii) or (iii) above shall relieve Talecris GmbH
from any obligation hereunder. Rosia may assign this Agreement and any or all
rights or obligations hereunder to (i) any affiliate of Rosia; or (ii) any
successor in interest to the entire business conducted by Rosia under this
Agreement provided that any such successor becomes a party to this Agreement;
provided that no assignment under (i) or (ii) above shall relieve Rosia from
any obligation hereunder. Any purported assignment in contravention of this
Section 16.2 shall be void. For the avoidance of doubt, and provided that it
complies with all of the relevant provisions of this Agreement, Rosia may
perform its obligations hereunder at any Rosia facility approved for such
activities by the applicable regulatory authorities.

 

16.3         Severability. Any
provision of this Agreement which is or may become prohibited or unenforceable,
as a matter of law or regulation, will be ineffective only to the extent of
such prohibition or unenforceability and shall not invalidate the remaining
provisions. The Parties agree to replace an invalid provision with a provision
that is as close as possible to the intended economic effect of the Agreement
and which meets legal requirements hereof if the essential purposes of this
Agreement may be given effect despite the prohibition or unenforceability of
the affected provision.

 

16.4         Waiver  Each of the Parties shall have the right at
all times to enforce the provisions of this Agreement in strict accordance with
the terms hereof notwithstanding any conduct or custom on its part in
refraining from doing so at any time. The failure of either Party at any time
to enforce its rights hereunder strictly in accordance with the same shall not
be construed as having created a custom contrary to the specific provisions
hereof or as having in any way modified or waived the same.

 

16.5         Entire Agreement.
This Agreement, together with the Exhibits, constitutes the whole and entire
agreement between the Parties with respect to this subject matter and
supersedes all prior understandings, written or oral. Notwithstanding the
foregoing, Talecris GmbH and Rosia have entered into that certain Manufacture
Under Contract Agreement. In the event that this Agreement conflicts with any
Exhibit hereto, the Manufacture Under Contract Agreement, Purchase Order,
invoice, or other written documents, the terms and conditions of this Agreement
shall apply. No amendment or modifications hereof shall be binding unless in
writing and duly executed by authorized representatives of both Parties.

 

16.6         Survival. In
the event of any termination of this Agreement, the provisions of Articles 8,
9, 10, 11, 12, 14 and 15, and Sections 2.5, 2.6, 2.7, 2.8, 4.3, 4.4, 4.5, 5.1,
5.4, 5.6, 5.7, 6.3(i), 6.3(ii), 7.1, 7.3, 7.4, 13.5, 13.6, 13.7, 16.1, 16.3,
16.4, 16.5, 16.6, 16.8, 16.9, 16.10, 

 

28

16.12, 16.13 and 16.14 shall survive any
termination or expiration of this Agreement in full force and effect
indefinitely, unless a shorter period of survival is provided therein.

 

16.7         Force Majeure.
For the purpose of this Agreement, “Force Majeure”
shall mean only (i) acts of God, acts of the public enemy, insurrections,
riots, sabotage, strike, work-stoppage or other labor dispute and natural
disasters; (ii) explosions, fires, flood, damage, or loss of electric power not
resulting from the negligence of the Party invoking Force Majeure; (iii)
regulatory actions not attributable to any violation of law after the date
hereof on the part of Talecris GmbH or Rosia, as the case may be, unless, in
the case of Talecris GmbH, Talecris GmbH is required as a result of any
statute, law, regulation, ordinance, rule, judgment, code, order, decree or
other requirement of a Regulatory Authority (“Applicable Law”), not initiated by Talecris GmbH,
to cease or materially curtail production primarily based upon (x) violation of
any Applicable Law which violation was in existence on the Effective Date or
(y) any condition in existence on the Effective Date or any condition alleged
in writing to have been in existence on or prior to the Effective Date by a
Regulatory Authority which condition remained outstanding on the Effective Date
and which condition constituted a violation or alleged violation of Applicable
Law or impacts the safety or efficacy of the Contractual Products; and (iv)
events, circumstances, conditions and actions outside of the control of
Talecris GmbH or Rosia that materially and adversely affect the plasma-derived
Products industry generally, including interruptions of supply of raw plasma
due to viral outbreaks, eruption of new viruses and similar events, that are
reasonably likely to be subject to action by any Regulatory Authority; any of
(i), (ii), (iii) or (iv) of which, in the case of the Talecris GmbH, prevents
Talecris GmbH from performing its obligations under this Agreement, or any of
(i), (ii), (iii) or (iv) of which, in the case of Rosia, prevents Talecris GmbH
from performing its obligations under this Agreement, provided that nothing in
clause (iii) or (iv) shall excuse Talecris GmbH from complying with cGMP or
excuse Talecris GmbH from remedying those matters which were capable of remedy
by Talecris GmbH through the application of commercially reasonable efforts
prior to the occurrence of the events identified in (iii) or (iv) preventing
Talecris GmbH from performing under the Agreement. Notwithstanding anything in
this Agreement to the contrary, except Article 10 and Article 16, the Party
experiencing the Force Majeure shall be excused from the performance of each of
its obligations under this Agreement upon a Force Majeure, but only to the
extent performance of any such obligation is necessarily prevented, hindered or
delayed thereby and only during the continuance of any such Force Majeure, and
shall have no liability for damages arising from non-performance of any
obligation excused by a Force Majeure. The Party suffering such Force Majeure
shall invoke this provision by promptly notifying the other Party in writing of
the nature and estimated duration of the suspension period, as well as the
extent to which it will be unable to fulfill its obligations under this
Agreement. Each Party shall be relieved of performance of its obligations under
this Agreement during the time when it is prevented from performing by the failure
of the other Party to perform its obligations or because of any event of Force
Majeure.

 

16.8         Notices. All
notices, requests, demands and other communications required or permitted
hereunder shall be in writing and if mailed by prepaid first class mail or
certified mail, return receipt requested, at any time other than during a
general discontinuance of postal service due to strike, lockout or otherwise,
shall be deemed to have been received on the earlier of the date shown on the
receipt or three (3) business days after the postmarked 

 

29

date thereof and, if telexed or telecopied,
the original notice shall be mailed by prepaid first class mail within
twenty-four (24) hours after sending such notice by telex or telecopy, and
shall be deemed to have been received on the next business day following
dispatch and acknowledgment of receipt by the recipient’s telex or telecopy
machine. In addition, notices hereunder may be delivered by hand, in which
event the notice shall be deemed effective when delivered, or by overnight
courier, in which event the notice shall be deemed to have been received on the
next business day following delivery to such courier. All notices and other
communications under this Agreement shall be given to the Parties hereto at the
following addresses:

 

If to Rosia:

 

Bayer
Biologicals S.r.l.

Viale Certosa
130, 20154 Milan, Italy

Attention:  General Director

 

With a copy to:

 

Vice
President, General Counsel and Secretary

Bayer
HealthCare, LLC

400 Morgan
Lane

West Haven,
CT  06516-4175

Fax:  (203) 812-2795

 

If to Talecris
GmbH:

 

Talecris
Biotherapeutiecs, GmbH

ATRICOM,
Lyoner Strasse 15

Frankfurt,
60528

 

With copies to:

 

Talecris
Biotherapeutics, Inc.

Attention:  Legal Department

79 TW Alexander
Drive

4101 Research
Commons

Research
Triangle Park

Raleigh,
NC  27709

Fax;  (919) 316-6677

 

Any Party
hereto may change its address specified for notices herein by designating a new
address by notice in accordance with this Section 16.8.

 

16.9         Captions. All
captions are inserted for convenience and will not affect any construction or
interpretation of this Agreement.

 

16.10       Dispute Resolution.

 

(i)            Resolution
by the Parties. The Parties shall attempt to resolve any dispute,
controversy, claim or difference arising out of, or in connection with, this
Agreement amicably and promptly by negotiations between executives who have
authority to settle the controversy. Either Party may give the other Party
written notice of any dispute not 

 

30

resolved in the normal course of business (“Notice of Dispute”). Within seven
(7) days after delivery of such Notice of Dispute, executives of the Party
shall agree to meet at a mutually acceptable time and place, and thereafter as
often as they reasonably deem necessary, to attempt to resolve the dispute. If
the matter has not been resolved within ten (10) days of the first meeting of
such executives (or if the Parties are unable to mutually agree upon an
acceptable time and place to meet, within ten (10) days of the disputing Party’s
Notice of Dispute), either Party may, by notice to the other Party (“Dispute Escalation Notice”), refer
the matter to the respective officers of the Parties designated below.

 

For Rosia:              General Director, Bayer
Biologicals S.r.l.

 

With a copy to:

 

Vice
President, General Counsel and Secretary

Bayer
HealthCare, LLC

400 Morgan
Lane

West Haven,
CT  06516-4175

Fax:  (203) 812-2795

 

For Talecris
GmbH:

 

Talecris
Biotherapeutiecs, GmbH

ATRICOM,
Lyoner Strasse 15

Frankfurt,
60528

 

Such officers
shall negotiate in good faith to resolve the matter in an amicable manner
within ten (10) days of the Dispute Escalation Notice. In the event the matter
is not resolved within such ten (10) days, either party may initiate
arbitration of the dispute as provided for in this Section 16.10.

 

(ii)           In
any event, if the dispute, other than with respect to Article 10, is not
resolved in accordance with this Section 16.10, within thirty (30) days of the
date in which such dispute arose, either party may submit the dispute to
binding arbitration by giving the other Party notice (the “Arbitration
Notice”). Such arbitration shall be conducted in accordance with
the Rules of Arbitration of the International Chamber of Commerce in effect as
of the Effective Date (the “Rules”). The arbitration shall take place in a
location which is mutually agreeable to the Parties and shall be held in the
English language. The arbitration will be conducted by one (1) arbitrator
knowledgeable in the subject matter that is at issue in the dispute and who is
selected by mutual agreement of the Parties or, failing such agreement by
thirty (30) days after the Arbitration Notice was given, will be selected
according to the Rules. Either Party reserves the right to object to any
individual arbitrator who shall be employed by or affiliated with a competing
organization. The arbitrator shall render a decision no later than ninety (90)
days from the date of such arbitrator’s selection. The award of the arbitrator
shall be final and binding on both Parties. Each Party hereby submits itself to
the jurisdiction of the courts of the place where arbitration is held, but only
for the entry of judgment with respect to the decision of the arbitrator
hereunder. Notwithstanding the foregoing, judgment upon the award may be
entered in any court in the state where the arbitration takes place, or any
court having jurisdiction over the Parties. In the event of any actual or
threatened breach or default which could give rise to irreparable harm, nothing
in this Agreement shall prevent either Party from seeking injunctive relief (or
any other provisional remedy or equitable relief) from any court having
jurisdiction over the Parties and the subject matter 

 

31

of this dispute to protect their respective rights
pending the outcome of the arbitration. The Parties bind themselves to carry
out the awards of the arbitrator. The fees and expenses of the arbitrator, the
fees and expenses of the court report and any expense for a hearing room, and
reasonable attorney’s fees may be awarded to the prevailing party by the
arbitrator, or if such award is not made, will be shared equally by the Parties.
The Parties will otherwise bear their respective expenses of arbitration.

 

16.11       Independent
Contractor. This Agreement does not create an employer-employee
relationship between the Parties, and is not an agency, joint venture or
partnership. Neither Party shall have the authority to act for the other or to
bind the other in any way, nor to sign the name or to represent that the other
is in any way responsible for the acts of omissions of the other. Rosia shall
maintain its status as an independent contractor engaged in the selling of the
Finished Products to Talecris GmbH.

 

16.12       English Language.
In the event that this Agreement is translated to any language other than
English, this English version of this Agreement shall prevail.

 

16.13       Set-Off. No
party to this Agreement shall have any right of set-off with respect to amounts
it has an obligation to pay hereunder.

 

16.14       Defined Terms. Defined
terms used but not otherwise defined in this Agreement shall have the meaning
ascribed to those terms in the Contribution Agreement.

 

(Remainder
of this page has been intentionally left blank)

 

32

 

IN WITNESS
WHEREOF, the Parties have caused this Agreement to be executed by their duly
authorized representatives as of the Effective Date.

 

	
  BAYER BIOLOGIALS S.R.L.

  	
  TALECRIS BIOTHERAPEUTICS, GMBH

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Authorized Signatory

  	
   

  	
  By:

  	
  /s/ Authorized Signatory

  	
   

  
	
  Name:

  	
  Authorized Signatory

  	
   

  	
  Name:

  	
  Authorized Signatory

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  

 

 

EXHIBITS TO THE EUROPEAN PRODUCT SALES
AGREEMENT (PHASE I)

 

BY AND BETWEEN TALECRIS BIOTHERAPEUTICS, GMBH

 

AND BAYER BIOLOGICALS S.R.L.

 

	
  Exhibit 1

  	
   

  	
  List of Contractual Products and Prices

  
	
   

  	
   

  	
   

  
	
  Exhibit 2

  	
   

  	
  Finished Products and Prices

  
	
   

  	
   

  	
   

  
	
  Exhibit 3

  	
   

  	
  [Deliberately Left Blank]

  
	
   

  	
   

  	
   

  
	
  Exhibit 4

  	
   

  	
  Contacts and Responsible Persons

  
	
   

  	
   

  	
   

  
	
  Exhibit 5A

  	
   

  	
  Rosia Economic results

  
	
   

  	
   

  	
   

  
	
  Exhibit 5B

  	
   

  	
  Rosia Economic results

  
	
   

  	
   

  	
   

  
	
  Exhibit 6

  	
   

  	
  Specifications

  
	
   

  	
   

  	
   

  
	
  Exhibit 7

  	
   

  	
  European

  
	
   

  	
   

  	
   

  
	
  Exhibit 8A

  	
   

  	
  Agreement on Manufacture under Contract until Talecris becomes
  releaser

  
	
   

  	
   

  	
   

  
	
  Exhibit 8B

  	
   

  	
  Agreement on Manufacture under Contract after Talecris becomes
  releaser

  
	
   

  	
   

  	
   

  
	
  Exhibit 9

  	
   

  	
  Labeling and Packaging Specifications

  
	
   

  	
   

  	
   

  
	
  Exhibit 10

  	
   

  	
  Regulations

  
	
   

  	
   

  	
   

  
	
  Exhibit 11

  	
   

  	
  Exchange of Information Related to Safety Matters

  

 

 

Exhibit 1

 

 

[***]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 2

 

 

[*** 2 pages redacted]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 3 [deliberately left blank]

 

 

 

 

Exhibit 4

 

 

[*** 2 pages redacted]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 5A

 

 

[*** 4 pages redacted]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 5B

 

 

[*** 3 pages redacted]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 6

 

 

[***]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 7

 

 

[*** 3 pages redacted]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 9

 

 

[***]

***CONFIDENTIAL TREATMENT REQUESTED

 

 

Exhibit 10

 

 

[***]

***CONFIDENTIAL TREATMENT REQUESTED

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00130-of-00352.parquet"}]