EX-4.53 6 u49003exv4w53.htm EXHIBIT 4.53 exv4w53
 

Exhibit 4.53

 

Confidential treatment has been requested for certain portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as “ ***** ”. A complete version of this exhibit has been filed separately with the Commission pursuant to an application for confidential treatment under Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

 

Modification 0001

ACAMBIS SUBCONTRACT MODIFICATION 0001

Subcontract No : MVA 2004-00001BXTR

Modification No.: 0001

Effective Date: Upon Subcontract Award

         
Subcontractor:   Baxter Healthcare SA
    Hertistrasse 2
 
      H-8304 Wallisellen, Switzerland

Description of Modification:

            Option Exercise of Specified Contract Line Items (CLIN’s)
            (See Page 2.)

Authority for modification: Unilateral modification under paragraph H.25

Total Value of this Modification: $ *****

For: ACAMBIS, INC.           Execution Date: September 30, 2004

/s/ Roger J. McAvoy

Roger J. McAvoy
Vice President,
Contracts and Legal Affairs

 


 

Modification 0001

SECTION B

     1. Under paragraph H.25, the following Option Contract Line Items (CLIN’s) are hereby exercised:

             
CLIN   Description   Unit   Amount
CLIN 0001
  Process Development, Validation, and Manufacturing   N/A   N/A
 
           
CLIN 0001AA
(Milestone 1)
  Product Development Plan (PDP)   Lot   $ *****
 
           
CLIN0001AB
(Milestone 17)
  PDP and Quality Systems Plan (QSP) Updates   PDP Update
QSP Update
  *****
*****
 
           
CLIN0001AC
(Milestone 2)
  QSP   Lot   *****
 
           
CLIN0001AD
(Milestone 5)
  Regulatory Support Plan
(Manufacturing)
  Lot   *****
 
           
CLIN0001AE
(Milestone 16)
  Updated Regulatory Support Plan   Lot   *****
 
           
CLIN 0001AF
(Milestone 6)
  Summary Report   Lot   *****
 
           
CLIN 0001AG
(Milestone 7)
  Process Validation and Manufacture and Delivery of MVA Vaccine Vials   500,000 doses
(a) (Full Testing)
*****
  (a) (Full Testing)
*****
 
           
 
      (b) *****   (b) *****
 
           
 
      (c) *****   (c) *****
 
           
 
      (d) *****   (d) *****
 
           
CLIN 0001AH
(Milestone 1)
  Small-Scale Lyo Study   Lot   *****
 
           
CLIN 0002
  Vaccine Stockpile Maintenance Plan   N/A   N/A
   
 
       
 
           
CLIN 0002AA
(Milestone 8)
  Maintenance, Testing, and Replenishment Plan   Lot   *****
 
           
CLIN 0003
  Large-Scale Manufacturing   N/A   N/A
   
 
       

2


 

Modification 0001

             
CLIN   Description   Unit   Amount
CLIN 0003AA
(Milestone 9)
  Large-Scale Production Plan   Lot   *****
 
           
CLIN 0004
  Stockpile Maintenance/Stability Studies   N/A   N/A
 
           
CLIN 0004AA
(Milestone 18)
  Stability Program   Lot   *****
 
           
CLIN 0005
  Replenishment Vaccine   N/A   N/A
 
           
CLIN 0005AA
(Milestone 18)
  Vials MVA Vaccine   Number of Lots - As ordered (300,000 doses/Lot)    
 
           
 
      (a) Full Testing
*****
  (a) (Full Testing)
*****
 
           
 
      (b) *****   (b) *****
 
           
 
      (c) Limited Testing *****   (c)(Limited Testing) *****
 
           

 
      (d) Limited Testing with
*****
  (d) *****
 
           
CLIN 0006
  Other Direct Cost (Travel)   Lot   *****

3