ex10_22.htm


  


    Exhibit
10.22

    
      	
               CONFIDENTIAL MATERIALS OMITTED
      AND FILED SEPERATLY WITH THE SECURITIES AND EXCHANGE COMMISSION. 
      

              ASTERISK DENOTE
      OMISSIONS. 

            


    

     

    Talecris

    BIOTHERAPEUTICS

    


    First
Addendum to

    Product
Supply Agreement

    


     

    This
First Addendum (this "Addendum") to that certain
Product Supply Agreement dated June 12, 2006, as previously amended on December
19, 2006, June 25, 2007, and August 29, 2007, and as hereinafter amended from
time to time (the "Agreement"), is entered into
as of August 15, 2009, and effective as of        September
1,
2009                   
(the "Addendum Effective
Date"), by and between Talecris Biotherapeutics, Inc., ("Talecris") headquartered at 79
T.W. Alexander Drive, 4101 Research Commons, P.O. Box 110526, Research Triangle
Park, North Carolina 27709 and Emergent Product Development Gaithersburg Inc.
("Emergent"), a Delaware
corporation having offices at 300 Professional Drive, Gaithersburg, MD 20879.
For the purposes of this Addendum, Emergent and Talecris shall each be deemed a
"Party" and together the
"Parties." All terms not
defined herein shall have the meaning set forth in the Agreement.

     

     

    WHEREAS,
the Parties entered into the Agreement in order to, among other things, allow
for Talecris to receive, process, and manufacture human plasma, plasma
intermediates, final container products (such as Finished Product) and other
materials (collectively, the "Materials") on behalf of
Emergent or its agents; and

     

     

    WHEREAS,
the Parties have determined that, in addition to the rights and obligations set
forth in the Agreement, Talecris has in the past and will continue to store,
warehouse, and hold Materials on behalf of Emergent or its agents as more fully
described herein.

     

     

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

     

    
      	
              1)  

            	
              Business
      Terms.

            


    

     

    
      	
              a.  

            	
              Services. Upon
      the terms and conditions set forth below or as otherwise required by the
      Agreement or the applicable Material Storage Schedule, Emergent hereby
      engages Talecris to store Materials as specified in a Material Storage
      Schedule executed hereunder (the "Services"). Talecris
      reserves the right, upon reasonable advance notice to Emergent, to refuse
      to accept or accumulate Materials on behalf of Emergent that are in
      addition to those Materials specified in any executed Material Storage
      Schedule; provided, however, that the foregoing right of refusal shall not
      apply to any Materials set forth in any mutually-agreed rolling forecast
      of Materials to be manufactured by
Talecris.

            


    

     

    
      	
              b.  

            	
              Standards and
      Conditions.

            


    

     

    
      	
              i.  

            	
              General.  Unless
      otherwise specified in the applicable Material Storage Schedule or
      required by applicable law, cGMP (if applicable) or good practices for the
      industry, Talecris shall use Commercially Reasonable Efforts in the
      performance of Services.

            


    

     

    
      	
              ii.  

            	
              Storage
      Conditions. Unless otherwise agreed in writing, Talecris will
      store, otherwise handle and maintain the Materials using the same degree
      of care, under the same conditions, and in the same facilities as Talecris
      does for its own products and materials of a similar nature. Talecris
      shall perform the Services in accordance with its then-current standard
      operating procedures, plans, protocols, and business judgment. Talecris
      reserves the right to transfer Materials to other Talecris-owned or
      controlled locations or facilities as reasonably necessary to ensure the
      continued proper storage and handling of such Materials; provided,
      however, that Talecris shall not make any transfer to any location or
      facility not owned or controlled by Talecris without providing Emergent
      with at least thirty (30) days' written notice and allowing Emergent a
      reasonable opportunity to inspect or otherwise obtain relevant information
      regarding the suitability of such alternate facility. Talecris shall be
      solely responsible for any breaches of this Addendum or the Agreement by a
      third party storage agent or transporter, except in the event that such
      third party is engaged under emergency circumstances in an attempt to
      prevent or limit loss of, or damage to, the Materials pursuant to section
      1(b)(iv) below.

            


    

     

    
      	
              iii.  

            	
              Location.
      Talecris will store Materials at any of its facilities in Clayton, NC
      and/or Benson, NC (the "Facilities"), unless
      otherwise agreed between the Parties. Regardless of location, Talecris
      shall monitor and record temperature as required by applicable laws and
      regulations, and in any event, shall do so in the same manner it addresses
      such data concerning its own products and materials in the same
      Facilities.

            


    

     


    
      
         


      

      
         


         


      

      
         


      

    


    


     

    
      	
              iv.  

            	
               Emergency
      Situations. In the event of an emergency or other urgent situation
      that Talecris, in its best judgment, believes may lead to damage or risk
      to the Materials, Talecris reserves the right to transfer some or all
      Materials to an alternative location or storage facility. To the extent
      reasonably possible and prudent, Talecris will transfer the Materials in
      the same manner and with the same frequency that Talecris transfers its
      own products and materials of a similar nature that are being stored at
      the same Facility and in proximity to the Materials. In the event that
      Talecris utilizes the facilities of any third party in connection with
      such transfer or eventual storage, Talecris shall use commercially
      reasonable efforts to require such third party to be bound to Talecris by
      obligations with respect to the storage and handling of Materials that are
      substantially similar to those contained in this Addendum. Talecris shall
      notify Emergent promptly of any transfer made pursuant to this subsection,
      and use its best commercial efforts to notify Emergent in advance. In the
      event that Emergent requires or prohibits moving, modifying or storing the
      Materials in a manner against the recommendations or instructions of
      Talecris, Emergent shall, except for the gross negligence or intentional
      misconduct of Talecris or its agents, be solely responsible for any harm
      or damage to the Materials incurred thereafter with respect to the
      Materials stored or moved against the recommendations or instructions or
      Talecris. In the event that Emergent determines, in its sole discretion,
      to re-transfer or otherwise assume control of or responsibility for such
      transferred Materials, Talecris shall reasonably cooperate with and assist
      Emergent in completing such
activities.

            


    

     

    
      	
              v.  

            	
              Performance.
      With respect to certain Materials which may be specified above, the
      Parties agree as follows:

            


    

     

    
      	
              1.  

            	
              Final
      Product: Storage of Final Product by Talecris will not be deemed
      "Services" under this Addendum until such Final Product is released by
      Talecris to Emergent pursuant to the terms of the Agreement and Talecris
      issues the corresponding invoice to Emergent for the product Processing
      Fee.

            


    

     

    
      	
              2.  

            	
              Plasma
      and Paste: Storage of plasma and paste by Talecris will not be deemed
      "Services" until after Talecris has held such Materials for three (3)
      months.

            


    

     

    
      	
              vi.  

            	
              Removal of
      Materials. Talecris may, upon six (6) months' prior written notice
      to Emergent, require removal of Materials from the Facility; provided,
      however, that Talecris shall not require such removal as a result of any
      agreement to store a third party's products or materials of a similar
      nature at the Facility. Notwithstanding the foregoing, in the event that
      Emergent reasonably determines that it cannot locate a suitable storage
      facility for the Materials or otherwise arrange for alternate storage
      within such six-month period, Talecris shall use commercially reasonable
      efforts to cooperate with Emergent and will extend the storage period at
      the Facility until such time as Emergent secures alternate storage for the
      Materials. In no event shall the foregoing storage period extend beyond
      twelve (12) months from the original removal notice date. Emergent may,
      upon ten (10) business days' prior written notice, require delivery (in
      accordance with the terms of the Agreement) of all or any part of the
      Materials from the Facility; provided, however, that the Parties
      acknowledge and agree that Talecris shall be allowed additional time to
      prepare Materials for delivery if reasonably necessary and upon notice to
      Emergent of the reasons for any such delay. Upon request by either Party
      to deliver Materials to Emergent, Talecris shall cooperate with Emergent
      with respect to removal of Materials and, at Emergent's expense, follow
      Emergent's reasonable written instructions for such removal. Talecris
      reserves the right to withhold such cooperation until all amounts due and
      payable by Emergent to Talecris (except to the extent disputed in good
      faith) in connection with this Addendum are paid to
    Talecris.

            


    

     

    
      	
              c.  

            	
              Delivery
      Conditions. Delivery of Materials will be made to Emergent or such
      other Persons approved by Emergent in writing at such time(s) as
      reasonably determined by Emergent.

            


    

     

    
      	
              d.  

            	
              Compensation / Payment
      Terms

            


    

     

    
      	
              i.  

            	
              Subject
      to the terms of any Material Storage Schedule, Emergent agrees to pay, and
      Talecris agrees to accept payment, for all Services properly rendered
      during the term of this Addendum. Payment and prices shall be as set forth
      on the applicable Material Storage Schedule. Talecris shall be solely
      responsible for its expenses related to this Addendum unless otherwise
      expressly agreed by Emergent in writing. Such expenses are not to exceed
      $175 per pallet per month without the express written preapproval of
      Emergent, which will not be unreasonably withheld. Notwithstanding the
      foregoing, Emergent shall be responsible for any reasonable expenses
      necessarily incurred by Talecris in connection with preservation,
      relocation or transfer of Materials as described in Paragraph 1) b) iv)
      above.

            


    

     

    
      	
              ii.  

            	
              Emergent
      shall pay all undisputed amounts to Talecris net-thirty (30) days from the
      date of an invoice showing in reasonable detail the basis for such
      invoice, and the amount currently due, as set forth herein. All invoices
      shall be submitted in writing to Emergent as
  follows:

            


    

     

    Manner and Location for
Payments: U.S. first-class mail to primary business address

     

    Accounting
Codes  (Must be noted on all invoices
for. payment to be
processed):

     


    
      
         


      

      
         


         


      

      
         


      

    


    G/L
No.:                                                           Cost
Center:

     

    Project Code (if
applicable):

     

    Address for Invoices to
Emergent:           Emergent
BioSolutions Inc.

    2273
Research Blvd., Suite 400

    Rockville,
MD 20850

    Attn:
Accounts Payable

    


    
      	
              e.  

            	
              Risk of Loss /
      Insurance.
      Risk of loss for Materials stored by Talecris pursuant to this
      Addendum shall be governed by the terms of the Agreement. Notwithstanding
      the foregoing, the parties acknowledge and agree that except to the extent
      caused by Talecris' gross negligence, intentional misconduct or material
      breach of this Addendum, upon the release of Finished Product to Emergent,
      all risk of loss for such Finished Product shall be borne by Emergent,
      even if such Finished Product is stored by Talecris pursuant to this
      Addendum.

            


    

     

    
      	
              f.  

            	
              Warranty &
      Disclaimer. TALECRIS IS NOT A COMMERCIAL STORAGE FACILITY OR
      STORAGE SERVICES PROVIDER. ACCORDINGLY, WITH RESPECT TO THE SERVICES
      COVERED BY THIS ADDENDUM, TALECRIS MAKES NO WARRANTY OF MERCHANTABILITY,
      SATISFACTORY QUALITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR
      OTHERWISE.

            


    

     

    
      	
              g.  

            	
              Limitation of
      Liability; Damages. Talecris shall have no liability hereunder to
      the extent arising from negligent acts or omissions. Except to the extent
      caused by Talecris' gross negligence,
      intentional misconduct or material breach of this Addendum, Talecris'
      aggregate liability for any losses, injury or damages to persons,
      Materials, or properties arising out of or in connection with this
      Addendum or for any other claims, losses, costs or damages whatsoever
      arising out of or resulting from or in any way related to the Services or
      this Addendum from any causes or causes, arising under any theory of law,
      shall be limited to the total amount of compensation actually received by
      Talecris from Emergent under this Addendum during the preceding eighteen
      (18) months. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY IN CONTRACT
      OR IN TORT FOR INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OR FOR LOST
      PROFITS ARISING HEREUNDER, EXCEPT TO THE EXTENT OF GROSS NEGLIGENCE OR
      WILLFUL MISCONDUCT ON THE PART OF SUCH PARTY, ITS EMPLOYEES, AGENTS,
      REPRESENTATIVES, OR SUBCONTRACTORS. The liability of each of Talecris and
      Purchaser to the other for any damages arising under this Agreement shall
      not exceed five million U.S. Dollars
  ($5,000,000).

            


    

     

    
      	
              h.  

            	
              Insurance.
      Emergent, at its own expense, shall submit to Talecris prior to
      commencement of the Services under this Addendum, certificates of
      insurance evidencing that such insurance was obtained. Deductible amounts
      under the foregoing policies shall be paid by Emergent. Without limiting
      the insurance requirements under the Agreement, Emergent shall maintain at
      least $2,000,000 in transit insurance and $15,000,000 in property
      insurance, covering Materials (including finished products) stored at
      Talecris' facility, pursuant to this Addendum. For the duration of this
      contract and for three years thereafter, Emergent and Talecris shall
      maintain General Liability and Products Liability insurance or
      self-insurance with minimum limits of $5,000,000 per occurrence.
      Certificates of insurance providing evidence of such coverage shall be
      provided to each respective Party when the contract is signed. Talecris
      shall reasonably cooperate with Emergent for the scheduling and completion
      of any reasonable or necessary insurance-related loss-control inspections
      of the Facility, which inspections shall not occur more frequently than
      once per year during the Term of this Addendum. The findings of any such
      inspections shall be used solely to establish Emergent's insurance rates
      and terms, and shall not be understood or used to obligate Talecris to
      modify its conduct or policies, or otherwise to take or refrain from
      taking any specific action.

            


    

     

    
      	
              i.  

            	
              Nonexclusive.
      Notwithstanding the terms of the Agreement (including Section 2.04
      (Exclusivity)), and notwithstanding the terms of the Exclusivity Agreement
      referenced in such Section, the parties agree that except with respect to
      removal of Materials as specified in Paragraph 1) b) vi) above and storage
      commitments described in Paragraph 1) a), the Services governed by this
      Addendum shall be nonexclusive with respect to each Party. Nothing shall
      prohibit Talecris from providing similar or identical services to other
      entities, and nothing shall prohibit Emergent from obtaining similar or
      identical services from other
entities.

            


    

     

    
      	
              2)  

            	
              Confidentiality.
      This Addendum, and the rights and obligations arising hereunder, shall be
      deemed confidential information subject to Article 13 (Confidentiality) of
      the Agreement.

            


    

     


    
      
         


      

      
         


         


      

      
         


      

    


    


     

    
      	
              3)  

            	
              Applicable Law.
      This Addendum and any matters arising directly or indirectly herefrom
      shall be governed by and construed and enforced in accordance with the
      laws of the United States and the internal laws of the State of New York,
      without regard to conflicts of law
principles.

            


    

     

    
      	
              4)  

            	
              Effect. Except
      as expressly set forth herein, this Addendum shall not limit or otherwise
      affect any term or provision of the Agreement, and all other terms and
      conditions of the Agreement shall survive and shall remain in full force
      and effect. This Addendum is hereby incorporated into and made a part of
      the Agreement. Specifically, but without limitation, the following
      sections of the Agreement shall, except as modified herein, apply to this
      Addendum: 15.11 (Force Majeure), 15.13 (Limitation of
      Damages).

            


    

     

    
      	
              5)  

            	
              Term and
      Termination.

            


    

     

    
      	
              a.  

            	
              Term. Unless
      earlier terminated as set forth below, this Addendum shall be in effect
      from the Addendum Effective Date until the termination or expiration of
      the Agreement, or until terminated in accordance with the terms of this
      Section.

            


    

     

    
      	
              b.  

            	
              Termination.

            


    

     

    
      	
              i.  

            	
              This
      Addendum may be terminated by mutual written agreement by the
      Parties.

            


    

     

    
      	
              ii.  

            	
              Either
      Party may terminate this Addendum for a material breach hereof by the
      other Party by providing thirty (30) days written notice to the other
      Party, unless such breach is cured within such thirty (30) day
      period.

            


    

     

    
      	
              iii.  

            	
              Except
      for removal of Materials as provided in Paragraph 1) b) vi), either Party
      may terminate this Addendum without cause by providing ninety (90) days
      written notice to the other Party.

            


    

     

    
      	
              iv.  

            	
              Termination
      of this Addendum shall not affect the binding nature or effectiveness of
      the Agreement. Breach of this Addendum by either Party shall not be deemed
      a breach of the Agreement.

            


    

     

    
      	
              6)  

            	
              Counterparts.
      This Addendum may be executed via facsimile signature and in any number of
      counterparts with the same effect as if all of the Parties had signed the
      same document. All fully executed counterparts shall be construed together
      and shall constitute one and the same
Agreement.

            


    

     

    


     

     

    IN
WITNESS WHEREOF, the Parties have executed this Addendum as of the Addendum
Effective Date,

     

    


    
      	
              TALECRIS
      BIOTHERAPEUTICS, INC.

            	
              EMERGENT
      PRODUCT DEVELOPMENT

            
	 
      	
              GAITHERSBURG
      INC.

            
	
              By:             /s/
      Craig Farquharson

            	
              By:               /s/
      Kyle Keese

            
	
              Name:        Craig
      Farquharson

            	
              Name:          Kyle
      Keese

            
	
              Title:          Senior
      Director Global Supply Chain

            	
              Title:         
        SVP Manufacturing OPS

            


    

    


     


    
      
         


      

      
         


         


      

      
         


      

    


     

    SCHEDULE
A-1

     

     

    MATERIAL
STORAGE SCHEDULE #1

     

     

    This
Schedule 1-A is made as part of the "FIRST ADDENDUM TO PRODUCT SUPPLY AGREEMENT"
(the "Addendum"), by and
between Talecris Biotherapeutics, Inc., ("Talecris") and Emergent
Product Development Gaithersburg Inc. ("Emergent"), and made subject
to the terms and conditions of the Product Supply Agreement referenced therein
(the "Agreement").

     

     

    Pricing:
Talecris shall perform the Services at the prices set forth herein, with respect
to the Materials specified in this Material Storage Schedule. Talecris reserves
the right to increase such prices after the first anniversary of this Material
Storage Schedule by a percent not to exceed the greater of (a) five percent (5%)
or (b) CP-M. "CPI-M" shall mean a percentage equal to the unadjusted percentage
change for the previous twelve-month period (ending four months prior to the
date of Talecris' price increase) published in the Consumer Price Index for
Medical Care, by the U.S. Department of Labor, Bureau of Labor
Statistics.

     

    Terms
for Material Storage Services Already Provided through August 2009:

     

    
      	
              Material

            	 	
              AIG
      Lot #

            	 	 	
              Cost
      per Pallet

              per
      Month

            	 	 	
              Number
      of

              Pallets

            	 	
              Storage

              Start-Date

            	 	
              Total
      Charges

            	 
	
              Final
      Container

            	 	 	[**]	 	 	$	[**]	 	 	 	2	 	
              March
      2007

            	 	$	[**]	 
	
              Final
      Container

            	 	
              [**]

            	 	 	$	[**]	 	 	 	2	 	
              June
      2008

            	 	$	[**]	 
	
              Final
      Container

            	 	
              [**]

            	 	 	$	[**]	 	 	 	2	 	
              June
      2009

            	 	$	[**]	 


    

    


     

     

    IN
WITNESS WHEREOF, the Parties have executed this Schedule as of the date of the
last signature below:

    
      	
              TALECRIS
      BIOTHERAPEUTICS, INC.

            	
              EMERGENT
      PRODUCT DEVELOPMENT

            
	 
      	
              GAITHERSBURG
      INC.

            
	
              By:               
       /s/ Craig Farquharson

            	
              By:               /s/
      Kyle Keese

            
	
              Name:           Craig
      Farquharson

            	
              Name:          Kyle
      Keese

            
	
              Title:             Senior
      Director Global Supply Chain

            	
              Title:            SVP
      Manufacturing OPS

            
	
              Date:             August
      27, 2009

            	
              Date:            1
      Sep 09