Document:

Exhibit 10.34.2

 

***TEXT OMITTED AND SUBMITTED SEPARATELY

PURSUANT TO CONFIDENTIAL TREATMENT REQUEST

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

 

AMENDMENT
TO

DISTRIBUTION
AGREEMENT

FOR EUROPE

This Amendment to the Distribution Agreement for Europe (this
“Amendment”) is entered into as of April 1, 2006 by and between Talecris
Biotherapeutics, Inc. (“Talecris”), Bayer Healthcare LLC (“Bayer”), Bayer
Biologicals S.r.l. (“B.Biologicals”) and the Distributors listed in Section 2
below (collectively, the “Distributors”). 
Capitalized terms used and not otherwise defined herein shall have the
meanings ascribed to such terms in the Original Agreement (as defined
below).  Talecris, Bayer, B.Biologicals
and the Distributors are sometimes referred to herein collectively as the “Parties,”
and individually as a “Party.”

WHEREAS, Bayer, Talecris, Talecris Holdings
LLC (f/k/a NPS Bio Holdings, LLC), a limited liability company organized under
the laws of the state of Delaware, and Talecris Biotherapeutics Holdings Corp.,
a corporation organized under the laws of the state of Delaware, entered into
that certain Amended and Restated Joint Contribution Agreement, dated as of
March 30, 2005 (the “Joint Contribution Agreement”), to provide for,
among other things, the contribution by Bayer to Talecris of assets of the
Plasma Business as described therein;

WHEREAS, The parties entered into that certain
Distribution Agreement, dated as of March 31, 2005 (the “Original Agreement”);

WHEREAS, The Parties desire to amend the Original
Agreement to extend its term with respect to the Distributors.

NOW, THEREFORE, for and 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 hereby
agree as follows:

1.             Effective Date.  This Amendment shall be effective as of April
1, 2006 and the changes made to the Original Agreement agreed to below shall
apply beginning on such date.  Prior to
that date, the terms of the Original Agreement shall continue to govern.

2.             Distributors
Being Extended.  Only the following
Distributors in the following countries are being extended and for the period
of the Extended Term (defined below) any reference to a “Distributor” under the
Original Agreement shall mean only the following:

	
  Bayer Entity

  	
   

  	
  Country

  
	
  Bayer S.A. -
  NY.

  	
   

  	
  Belgium

  
	
  Bayer Hellas
  AG

  	
   

  	
  Greece

  
	
  Bayer S.p.A.

  	
   

  	
  Italy

  
	
  Bayer Norge
  AS

  	
   

  	
  Norway

  
	
  Bayer
  Portugal AS

  	
   

  	
  Portugal

  
	
  Bayer
  (Schweiz)

  	
   

  	
  Switzerland

  
	
  Bayer AB

  	
   

  	
  Sweden

  

 

 

	
  Bayer Public
  Limited Company

  	
   

  	
  United
  Kingdom

  
	
  Bayer
  Gesellschaft m.b.H.

  	
   

  	
  Austria

  
	
  Quimicas
  Farmaceutica Bayer, S.A.

  	
   

  	
  Spain

  
	
  Bayer Oy

  	
   

  	
  Finland

  
	
  Bayer
  Denmark A/S

  	
   

  	
  Denmark

  
	
  Bayer Vital
  GmbH

  	
   

  	
  Germany

  

 

All of the other entities, if any, that served as Distributors under
the Original Agreement shall cease to be Distributors as of the end of the term
of the Original Agreement (March 31, 2006).

3.             Term.

(a)           The term under the
Original Agreement shall be extended until March 31, 2007 (the “Term”);
provided, however, that Talecris may terminate any Distributor prior to that
date upon six (6) months’ prior written notice given in accordance with Section
20.3 of the Original Agreement (the “Distributor Extended Term”); provided
further that the termination date given in any such notice may only be the last
day of a calendar month.  For the
avoidance of doubt, each notice of termination will necessarily be contingent
on final action of the responsible regulatory authorities.  In the event that required transfer of market
authorization or other necessary regulatory approvals cannot be secured prior
to the end of any Distributor Extended Term, upon the written request of
Talecris, Talecris (or its designee) shall become an authorized sub-distributor
of Distributor upon Distributor’s approval and consent, which shall not be
unreasonably withheld.

4.             Volume
Requirements.  Exhibit B of
the Original Agreement is hereby amended and replaced in its entirety with Exhibit
A attached hereto, with the amounts reflected thereon to be the “Required
Amount” for each Distributor for the Extended Term; provided however, that in
the event that Talecris terminates a Distributor prior to March 31, 2007 that
Distributor shall have no obligation to purchase its Required Amount of Product
for the period from the end of the Distributor Extended Term to March 31, 2007,
calculated by multiplying such Required Amount by a fraction, the numerator of
which is the number of months remaining in the Term after termination and the
denominator of which is twelve (12).

5.             Forecasts.  The forecasts provided for in Section 2.3(i)
of the Original Agreement shall be for rolling forecasts consisting of the
number of months remaining in the Distributor Extended Term.

6.             Support for
Commercial Activities.  If Talecris
terminates a Distributor prior to March 31, 2007, that Distributor shall
provide the level of support required under Section 3(iii) of the Original
Agreement for the duration of the Distributor Extended Term.

7.             [***]

***CONFIDENTIAL
TREATMENT REQUESTED

 

2

 

8.             [***]

9.             Promotion and
Information Expenditures.  If
Talecris terminates a Distributor prior to March 31, 2007, that Distributor
shall spend the amounts on P&I required under Sections 6.1(ii) and 6.1(iii)
of the Original Agreement for the duration of the Distributor Extended Term
provided that P&I shall be prorated by multiplying P&I by a fraction,
the numerator of which is the number of months in the Distributor Extended Term
hereunder divided by twelve (12).

10.           Adjustment to
Fixed SG&A Costs and Committed, Actual P&I Costs.  If Talecris terminates a Distributor prior to
March 31, 2007, such Distributor’s reimbursement for fixed SG&A costs and
committed, actual P&I costs shall be adjusted pursuant to Section 6.1(iv)
of the Original Agreement on a pro rata 12 month basis for the number of months
constituting the Extended Distributor Term.

11.           [***]

12.           Regulatory and
Other Support.  Bayer and its
Affiliates hereby designate Claudia Geis as the single point of contact that
Talecris may utilize to coordinate transitional issues for Europe.  This point of contact shall provide
reasonable assistance to Talecris in support of its efforts to secure from
Bayer, B.Biologicals or Distributors data or other information reasonably
needed to allow Talecris to complete the transition of Distribution activities
from Distributors to Talecris.

13.           Rosia.  For the avoidance of doubt, the Rosia Phase I
Agreement shall remain in full force and effect.

14.           Bayer Guaranty.  Bayer hereby agrees to (i) cause each
Distributor to duly execute and deliver an original copy of Exhibit K to
this Amendment to Talecris.  (ii) prior
to the time any Distributor becomes a party to this Amendment by executing and
delivering Exhibit K to Talecris, cause each Distributor to take any and
all actions required by such Distributor under

***CONFIDENTIAL
TREATMENT REQUESTED

 

3

 

 this
Amendment, as if such Distributor was a party hereto, and (iii) prior to the
time any Distributor becomes a party to this Amendment by executing and
delivering Exhibit K to Talecris, assume the indemnification obligations
of such Distributor pursuant to Article 16 of the Original Agreement as such
provision applies to this Amendment, as if such Distributor was a party hereto.

15.           Insurance.  Talecris maintains the product liability
insurance coverage set forth at Exhibit L hereto.  Talecris represents and warrants that such
insurance is in full force and effect and covenants that such insurance will
remain in full force and effect.  Upon
execution of this Agreement, Talecris shall cause Bayer and its Affiliates
acting as Distributors hereunder to become additional insureds thereto and
shall provide Bayer evidence thereof. 
The covenants contained herein shall survive indefinitely.

16.           Parties In
Interest.  The Original Agreement and
this Amendment and all of the provisions thereof shall be binding upon and
inure to the benefit of the parties hereto and their respective successors and
assigns, and it is not intended to confer upon any other person any rights or
remedies other than persons eligible for indemnification in accordance with
Section 11.

17.           Miscellaneous.  All other provisions of the Original
Agreement shall continue in accordance with the provisions of the Original
Agreement.  Each Party shall be
responsible for all fees, costs, and expenses incurred by it in connection with
the negotiation and execution of this Amendment.

*  *  *

[Signature
Page Follows]

 

4

 

IN WITNESS WHEREOF, the Parties have caused
this Amendment to be signed by their respective officers thereunto duly
authorized, all as of the date first written above.

	
   

  	
  TALECRIS
  BIOTHERAPEUTICS, INC.

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   /s/ Authorized Signatory

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Name:
  Authorized Signatory

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
  BAYER
  BIOLOGICALS S.R.L.

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Authorized Signatory

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Name:
  Authorized Signatory

  
	
   

  	
  Title:

  

 

Bayer Healthcare LLC is signing this Amendment solely to evidence its
agreement that it will meet the obligations in Section 14 of this Amendment or
any other provision of this Amendment or the Original Agreement where
performance of this Amendment or the Agreement would require Bayer to take some
action.

	
   

  	
  BAYER
  HEALTHCARE LLC

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ J. A.
  Akers

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Name: J. A.
  Akers

  
	
   

  	
  Title: EVP,
  Bayer Healthcare LLC

  
																												

 

 

5

 

Exhibit A

 

[***]

 

***CONFIDENTIAL
TREATMENT REQUESTED

 

6

 

 

Annex I

 

[***]

 

***CONFIDENTIAL
TREATMENT REQUESTED

 

 

7

 

 

Exhibit L

 

[***]

 

***CONFIDENTIAL
TREATMENT REQUESTED

 

 

8

 

 

Exhibit K

 

[***]

 

***CONFIDENTIAL
TREATMENT REQUESTED

 

 

9Exhibit 10.34.3

***TEXT OMITTED AND SUBMITTED SEPARATELY

PURSUANT TO CONFIDENTIAL TREATMENT REQUEST

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

 

THIS
AMENDMENT No. 2 (“Agreement”) is made and entered into as of July 18, 2007
by and between Talecris BioTherapeutics, Inc. (“Talecris), Bayer Biologicals,
Inc. and Bayer Healthcare LLC (“Bayer”), and certain European Marketing
Authorization Holders (collectively the “Parties”).

WHEREAS,
on March 30, 2005 Talecris, Bayer and Bayer Biologicals S.r.l. executed a
Distribution Agreement and subsequently amended on April 1, 2006
(collectively the “Original Distribution Agreement”) under which Talecris
products would be distributed in Europe;

WHEREAS,
the term under the Original Distribution Agreement has concluded;

WHEREAS,
Talecris continues to rely on certain Distributors to assist it in the
distribution of products, B.Biologicals and the Distributors are willing to
continue to assist Talecris beyond the term of the Original Distribution
Agreement;

WHEREAS,
Talecris has provided assurance it will replace all Distributors during the
period from April 1, 2007 to December 31, 2007 (“Additional Term”),
except as stated herein;

NOW,
THEREFORE, in consideration of the mutual covenants and agreements contained
herein, the Parties agree to amend the Original Distribution Agreement as
follows:

1.             Article I (Term) is replaced
with “This Agreement shall terminate on December 31, 2007” (“Termination
Date”).

2.             This Agreement will be deemed to
have been in full force and effect as of April 1, 2007 (“Commencement
Date”).

3.             The Distributors obligated by the
terms of this Agreement are those operating in the countries set forth in
Exhibit A (“Remaining Distributors”). No other Distributors will have
obligations under the tenns of this Agreement.

4.

(i)            Upon thirty (30) days written notice
by Talecris to any Distributor on Exhibit A (or such lesser period as Talecris
and the applicable Distributor may agree) Talecris may terminate this Agreement
effective the last day of the month in which the thirtieth day falls as
pertains to any specific Remaining Distributor receiving such notice, provided,
however, if Talecris has not provided such notice to all Distributors listed on
Exhibit A by November 30, 2007, such Distributors will be deemed to have
been served with such thirty (30) days notice of termination. For avoidance of
doubt the term Remaining Distributors as used in this Agreement shall include
only those Distributors listed on Exhibit A whose obligations have not been
terminated under the terms of this Section 4.

(ii)           The Termination of this Agreement
with respect to any individual Remaining Distributor prior to December 31,
2007 will be treated under Section 17.4 as a termination only with respect
to that individual Distributor. On December 31, 

2007
Section 17.4 will become applicable to all Remaining Distributors who have
not previously terminated the Agreement.

5.             For purposes of the Additional
Term, there shall be no Required Amount, Initial Forecast, other Forecast, or
Target Net Sales that shall pertain to or obligate any of the Parties
hereunder. Neither Bayer nor any of the Remaining Distributors shall be
obligated to deliver any Forecast during the Additional Term.

6.             [***]

7.             For purposes of the Additional Term
the amount of reimbursement of fixed SG&A costs and actual P&I under
Section 6.1(iv) shall not be adjusted based on the volume of sales,
provided, however, no Distributor shall materially increase its P&I
expenditures over the levels of expenditures in the prior twelve (12) months.

8.             For purposes of the Additional
Term, (i) Section 6.1(ii)(a) shall be deemed stricken;
(ii) Section 17.4(iii) shall only apply on and after the
Termination Date to any Remaining Distributor in Norway, provided the
Distributor’s obligation to assist and cooperate with Talecris under
Section 17.4(iii) shall terminate on March 31, 2007 and in no
event will Bayer, B. Biologicals or any Distributor be obligated to assist
Talecris after that date, (iii) the reference in Section 19 to
Exhibit J is stricken and replaced with Exhibit B, as attached hereto and Bayer
and the Remaining Distributors shall have the same obligations with respect to
the execution of Exhibit B under this Agreement as they had with respect to the
execution of Exhibit J under the Original Distribution Agreement.

9.             Except as expressly stated in this
Agreement, the Original Distribution Agreement remains in full force and
effect.

	
   

  	
  TALECRIS BIOTHERAPEUTICS, INC.

  
	
   

  	
   

  
	
   

  	
  BY:

  	
  /s/ Authorized Signatory

  
	
   

  	
  NAME:

  	
  Authorized Signatory

  
	
   

  	
  TITLE:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BAYER HEALTHCARE, LLC

  
	
   

  	
   

  
	
   

  	
  BY:

  	
  /s/ Authorized Signatory

  
	
   

  	
  NAME:

  	
  Authorized Signatory

  
	
   

  	
  TITLE:

  	
   

  
				

 

__________________

***CONFIDENTIAL TREATMENT
REQUESTED

 

2

 

EXHIBIT A

[***]

 

 

__________________

***CONFIDENTIAL TREATMENT
REQUESTED

 

EXHIBIT B

[***]

 

__________________

***CONFIDENTIAL TREATMENT
REQUESTED

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