Exhibit 10.1


 


	
  AWARD/CONTRACT

  	
   

  	
  1. THIS CONTRACT IS A
  RATED ORDER

  	
  

  	
   

  	
  RATING 

  	
   

  	
   

  
	
   

  	
   

  	
  UNDER
  DPAS (15 CFR 350)

  	
   

  	
  D0-C9

  	
   

  	
   

  	
   

  
	
  2. CONTRACT (Proc. Inst. Indent.) NO.

  	
   

  	
  3. EFFECTIVE DATE

  	
   

  	
  4. REQUISITION/PURCHASE
  REQUEST/PROJECT NO.

  
	
  W9113M-08-C-0028

  	
   

  	
  2 Jan
  2008

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5. ISSUED BY

  	
  CODE     W9113M

  	
   

  	
  6. ADMINISTERED BY (If other than Item 5)

  	
   CODE

  
	
  US ARMY SPACE &
  MISSILE DEFENSE COMMAND

  SMDC-RDCM 

  PO BOX 1500 

  HUNTSVILLE AL 35807-3801

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  7. NAME AND ADDRESS OF
  CONTRACTOR (No, street, city, county, State and Zip
  Code)

  	
   

  	
  8. DELIVERY

  
	
   

  	
   

  	
   

  
	
   

  	
  OSIRIS THERAPEUTICS, INC
  

  7015 ALBERT EINSTEIN DRIVE 

  COLUMBIA MD 21046-1707

  	
   

  	
  o FOB ORIGIN

  	
  x OTHER (See below

  
	
   

  	
   

  	
   

  	
  9. DISCOUNT FOR PROMPT
  PAYMENT 

  Net 30 

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CODE   06JU9

  	
   

  	
  FACILITY CODE

  	
   

  	
  10. SUBMIT INVOICES

  (4 copies unless other-

  wise specified) TO THE

  ADDRESS SHOWN IN:

  	
  

  	
  ITEM

  

           G

  
	
   

  	
   

  	
   

  	
   

  
	
  11. SHIP TO/MARK
  FOR    

  	
  CODE

  	
   

  	
  12. PAYMENT WILL BE MADE
  BY 

  	
  CODE

  	
  HQ0302

  
	
  See Schedule

  	
   

  	
   

  	
  DFAS-ROME 

  DFAS-RO-A, 325 BROOKS ROAD PHONE 800-553-0527 

  ROME NY 13441-4527

  
	
   

  	
   

  	
   

  	
   

  
	
  13. AUTHORITY FOR USING
  OTHER THAN FULL AND OPEN COMPETION:

  	
   

  	
  14. ACCOUNTING AND
  APPROPRIATION DATA



  
	
  o 10 U.S.C. 2304(c)
  (     )

  	
  o 41 U.S.C. 253(c)
  (     )

  	
   

  	
  See Schedule

  
	
   

  	
   

  	
   

  
	
  15A. ITEM NO.

  	
   

  	
  15B.
  SUPPLIES/SERVICES

  	
   

  	
  15C. QUANTITY

  	
   

  	
  15D. UNIT

  	
   

  	
  15E. UNIT PRICE

  	
   

  	
  15F. AMOUNT

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SEE SCHEDULE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  15G. TOTAL AMOUNT OF CONTRACT 

  	
  

  	
   

  	
  $4,253,390.80

  
																																								



 


	
  16. TABLE OF
  CONTENTS

  



 


	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  x

  	
  SEC.

  	
   

  	
  DESCRIPTION

  	
   

  	
  PAGE(S)

  	
   

  	
  x

  	
  SEC.

  	
   

  	
  DESCRIPTION

  	
   

  	
  PAGE(S)

  
	
   

  	
   

  	
   

  	
  PART I - THE
  SCHEDULE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PART II - CONTRACT
  CLAUSES

  
	
  x

  	
  A

  	
   

  	
  SOLICITATION/CONTRACT
  FORM

  	
   

  	
  1-3

  	
   

  	
  x

  	
  I

  	
   

  	
  CONTRACT CLAUSES

  	
   

  	
  19-25

  
	
  x

  	
  B

  	
   

  	
  SUPPLIES OR SERVICES AND
  PRICES/COSTS

  	
   

  	
  4-10

  	
   

  	
  PART III - LIST OF
  DOCUMENTS, EXHIBITS AND OTHER ATTACH.

  
	
  x

  	
  C

  	
   

  	
  DESCRIPTION/SPECS./WORK
  STATEMENT

  	
   

  	
  11

  	
   

  	
  x

  	
  J

  	
   

  	
  LIST OF ATTACHMENTS

  	
   

  	
  26

  
	
  x

  	
  D

  	
   

  	
  PACKAGING AND MARKING

  	
   

  	
  12

  	
   

  	
   

  	
  PART IV REPRESENTATIONS
  AND INSTRUCTIONS

  
	
  x

  	
  E

  	
   

  	
  INSPECTION AND
  ACCEPTANCE

  	
   

  	
  13

  	
   

  	
   

  	
  K

  	
   

  	
  REPRESENTATIONS,
  CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS 

  	
   

  	
   

  
	
  x

  	
  F

  	
   

  	
  DELIVERIES OR
  PERFORMANCE

  	
   

  	
  14-15

  	
   

  	
   

  	
   

  	
   

  
	
  x

  	
  G

  	
   

  	
  CONTRACT ADMINISTRATION
  DATA

  	
   

  	
  16

  	
   

  	
   

  	
  L

  	
   

  	
  INSTRS., CONDS., AND
  NOTICES TO OFFERORS

  
	
  x

  	
  H

  	
   

  	
  SPECIAL CONTRACT
  REQUIREMENTS

  	
   

  	
  17-18

  	
   

  	
   

  	
  M

  	
   

  	
  EVALUATION FACTORS
  FORAWARD

  	
   

  	
   

  
																				



 


CONTRACTING OFFICER WILL COMPLETE
ITEM 17 OR 18 AS APPLICABLE


 


	
  17. x  CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required in sign this document and return                 copies
  to issuing office.) Contractor agrees to furnish and deliver all
  items or perform all the services set forth of otherwise identified above and
  on any continustion sheets for the consideration stated herain. The rights
  and obligations of the parties to this contract shall be subject to and
  governed by the following documents: (a) this award/contract, (b) the solicitation,
  if any, and (c) such provisions, representations, certifications, and
  specifications, as are attached or incorporated by reference herein. (Attachments are listed herein)

  	
   

  	
  18. o AWARD (Contractor
  is not required to sign this document) Your offer on solicitation
  Number                        including
  the additions or changes made by you which additions or changes are set forth
  in full above, is hereby accepted as to the items listed above and on any
  continuation sheets. This award the consummates which consists of the
  following documents: (a) the Government’s solicitation and your offer, and
  (b) this award/contract. No further contractual document is necessary.

  



 


	
  19A. NAME AND TITLE OF SIGNER (Typs or
  print)

  	
  20A. NAME OF CONTRACTING OFFICER

  
	
  C. Randal Mills, President

  	
  LYNN M. SELFRIDGE

  
	
   

  	
   

  
	
  19B. NAME OF CONTRACTOR

  	
  19C. DATE SIGNED

  	
  20B. UNITED STATES OF AMERICA

  	
  20C. DATE SIGNED

  
	
  BY

  	
  /s/ C. Randal Mills

  	
  12/31/07

  	
  BY

  	
  /s/ Lynn M. Selfridge

  	
  1/3/08

  
	
   

  	
  (Signature of person authorized to sign)

  	
   

  	
   

  	
  (Signature of Contracting Officer

  
	
  NSN 7540-01-152-8069

  PREVIOUS EDITION UNUSABLE

  	
  26-107

  	
  STANDARD FORM 26 (REV. 4-85 Presented by GSA

  FAR (46 CFR 53.214(a)

  	
  USAPPCV 1.00

  



 


1
















 


W9113M-08-C-0028


 


Page 2 of 26


 


Section A - Solicitation/Contract Form


 


CONTINUATION OF FORM 26


Award is hereby made for the Development and Delivery of an FDA
Approved Medical Radiation Countermeasure (MRC) product.


 


The Osiris Therapeutics Inc. proposal dated August 10, 2007 as revised
on September 6, 2007, is incorporated into contract No. W9113M-08-C-0028 with
the following revisions.


 


1.                    Contract Data Requirements List (CDRL)
A001, A003, A004 and A008 are requirements associated with SLINs 0001A and 0001AB,
not 0001AD. Costs associated with these CDRLs are removed from option SLIN
0001AD and added into SLINs 0001AA and option 0001AB as shown in Section B.


 


2.                    SubCLINs (SLINs) 0004AA-0004AB are hereby
decreased to a quantity of 5,000 each, and SubCLINs 0004AC, and 0004AD are
hereby added with a quantity of 5,000 each. Prior to the first exercise of
these optional line items, the Government reserves the right to renegotiate
with Osiris the $10,000 unit price for these optional line items at a price not
to exceed (i) $10,000 or (ii) the lowest “most favored end user customer”
commercial price (including consideration of any discount or rebate
arrangement) at the time of negotiation; whichever is lower. If at any time any
of these options are exercised the product is commercially available to the
public (as defined by FAR part 2.101), the price shall not exceed the (i) the
lowest “most favored end user customer” commercial price paid or offered within
6 months of the option exercise or (ii) $10,000; whichever is lower.


 


3.                    All costs identified through the revised
proposal of September 6, 2007, include any costs that are a result of the
Osiris and Genzyme collaborative agreement.


 


4.                    Osiris Therapeutics Inc.’s shall
implement all recommendations as identified in DCAA Audit Report No.
6311-2007D17740064, within 3 months of contract award to have a fully compliant
accounting system audited by the DCAA and approved by the assigned ACO. If at
the end of the 3 months, Osiris has failed to fulfill this requirement, the
Government shall suspend acceptance of additional vouchers until the
requirements are completed.


 


5.                    CLIN 0002 is removed.


 


6.                    Section E. Inspection/Acceptance terms
have been added.


 


7.                    Section F. Manpower Reporting requirement
is removed.


 


8.                    Section H. Unamed clause after 52.234-4
is removed.


 


9.                    Section I.


 


                                                The following clauses are added by
reference:


                                                52.211-5, Material Requirements (Aug
2000)


                                                52.232-1, Payments - Fixed Price (Apr
1984)


                                                52.242-15, Stop Work Order (Aug 1989)


 


                                                The following clauses are incorporated by
full text:


                                                52.217-6, Option for Increased Quantity
(Mar 1989)


                                                252.211-7003, Item Identification and
Valuation (Jun 2005)


 


                                                The following clauses are revised to
include the most current version:


                                                52.203-6 (Sep 2006)


                                                52.204-7 (Jul 2006)


 

















 


W9113M-08-C-0028


 


Page 3 of 26


 


                                                52.209-6 (Sep 2006)


                                                52.222-26 (Mar 2007)


                                                52.222-35 (Sep 2006)


                                                52.244-6 (Mar 2007)


                                                252.209-7004 (Dec 2006)


                                                252.244-7000 (Jan 2007)


 


                                                The following clauses are deleted:


                                                52.230-2


                                                52.225-5 DEV


 


                                                10. Section J:


                                                CDRLs A001-A008 are corrected to include
the correct Contract Line Item Number.


 

















 


W9113M-08-C-0028


 


Page 4 of 26


 


                Section B -
Supplies or Services and Prices


 


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0001

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MRC Development and Delivery

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (Information CLIN only)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TARGET
  COST

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TARGET
  FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TOTAL
  TGT COST+ FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  MINIMUM
  FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  MAXIMUM
  FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  SHARE
  RATIO ABOVE TARGET

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  SHARE
  RATIO BELOW TARGET

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 
















W9113M-08-C-0028


 


Page 5 of 26


 


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  	 

	
  0001AA

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  Technology Development
  phase of the Advanced Development, Demonstration, and Delivery of a
  FDA-Approved therapeutic Medical Radiation Countermeasure (MRC) product in
  accordance with the contractor’s Statement of Work (SOW) dated August 10,
  2007. (As provided in response to the Government’s Statement of Objectives
  (SOO) located as an attachment to Section J generally, and the activities
  described in paragraph C.3.1 of the SOO specifically) to include delivery to
  the Government of, at a minimum, one dose of an Investigational New Drug (IND)
  that has 1) successfully undergone Phase 1 safety testing acceptable for a therapeutic
  MRC indication and 2) has received FDA authorization to proceed and is not
  subject to a clinical hold, and 3) has successfully completed two years of International
  Conference on Harmonisation-compliant stability testing, and 4) has undergone
  all other work specified in the Contractor’s SOW.

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TARGET COST

  	
   

  	
  $3,866,719.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET FEE

  	
   

  	
  $386,671.80

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TOTAL TGT COST+ FEE

  	
   

  	
  $4,253,390.80

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MINIMUM FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MAXIMUM FEE

  	
   

  	
  $773,343.78

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO ABOVE
  TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO BELOW
  TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ACRN AA

  	
   

  	
   

  	
   

  	
  $4,253,390.80

  	
   

  
	
  CIN: 000000000000000000000000000000

  	
   

  	
   

  	
   

  
																		



 


                                


 

















 


W9113M-08-C-0028


 


Page 6 of 26


	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  	 

	
  0001AA

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  System Development and
  Demonstration phase of the Advanced Development, Demonstration, and Delivery
  of a FDA-Approved therapeutic MRC product in accordance with the Contractor’s
  Statement of Work (SOW) dated August 10, 2007. (As provided in response to
  the Governments Statement of Objectives (SOO) located as an attacment to
  Section J generally, and the activities described in paragraph C.3.2 of the
  SOO specifically), to include delivery to the Government of, at a minimum,
  one dose of the FDA-approved MRC.

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TARGET COST

  	
   

  	
  $16,815,380.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TARGET FEE

  	
   

  	
  $1,681,538.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TOTAL TGT COST+ FEE

  	
   

  	
  $18,496,918.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  MINIMUM FEE

  	
   

  	
  $0.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  MAXIMUM FEE

  	
   

  	
  $3,363,076.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  SHARE RATIO ABOVE
  TARGET

  	
   

  	
  70/30

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  SHARE RATIO BELOW
  TARGET

  	
   

  	
  70/30

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0001AC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Implementation of an Earned Value Management (EVM)
  System in accordance

  	
   

  	
   

  	
   

  
	
  with DFARS 252.242-7002.

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET COST

  	
   

  	
  $241,229.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TARGET FEE

  	
   

  	
  $24,123.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  TOTAL TGT COST+ FEE

  	
   

  	
  $265,352.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  MINIMUM FEE

  	
   

  	
  $0.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  MAXIMUM FEE

  	
   

  	
  $48,246.00

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  SHARE RATIO ABOVE
  TARGET

  	
   

  	
  70/30

  	
   

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
   

  	
   

  	
  SHARE RATIO BELOW
  TARGET

  	
   

  	
  70/30

  	
   

  	 

																																		



 


 

















 


W9113M-08-C-0028


 


Page 7 of 26


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0001AD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Monthly Contract
  Performance Report in accordance with the relevant DD Form 1423, Contract
  Data Requirement List (CDRL). See Exhibit A005, attached in Section J. 

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET COST

  	
   

  	
  $801,485.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET FEE

  	
   

  	
  $80,149.20

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TOTAL TGT COST+ FEE

  	
   

  	
  $881,634.20

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MINIMUM FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MAXIMUM FEE

  	
   

  	
  $160,297.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO ABOVE
  TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO BELOW
  TARGET

  	
   

  	
  70/30

  	
   

  
																										



 


 


 


 


	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0001AE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Quarterly Contract Funding
  Status Report in accordance with the relevant DD Form 1423, Exhibit A002
  attached in Section J. 

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET COST

  	
   

  	
  $407,345.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TARGET FEE

  	
   

  	
  $40,734.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TOTAL TGT COST+ FEE

  	
   

  	
  $448,079.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MINIMUM FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  MAXIMUM FEE

  	
   

  	
  $81,469.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO ABOVE
  TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  SHARE RATIO BELOW
  TARGET

  	
   

  	
  70/30

  	
   

  
																	



 






 












 


W9113M-08-C-0028


 


Page 8 of 26


 


 


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0001AF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPIF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Technical Data Package to
  be delivered after FDA approval of MRC

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TARGET
  COST

  	
   

  	
  $190,582.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TARGET
  FEE

  	
   

  	
  $19,058.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TOTAL
  TGT COST+ FEE

  	
   

  	
  $209,640.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  MINIMUM
  FEE

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  MAXIMUM
  FEE

  	
   

  	
  $38,116.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  SHARE
  RATIO ABOVE TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  SHARE
  RATIO BELOW TARGET

  	
   

  	
  70/30

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0003

  	
   

  	
   

  	
   

  	
  1

  	
   

  	
  Lot

  	
   

  	
  $116,610.00

  	
   

  	
  $116,610.00

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Drug Master File.
  Exercised at Milestone B and shall be completed no later than

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  90 days once the option is
  exercised.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $116,610.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


 

















 


W9113M-08-C-0028


 


Page 9 of 26


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
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  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0004

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPTION

  	
   

  	
  Production End Items

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  HOSPITAL-BASED Medical
  Radiation Countermeasure (MRC): An MRC

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  suitable for delayed
  administration after diagnosis of the GI syndrome of ARS is

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  made and used at medical
  treatment facilities in the battle space and the sustaining

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  base, and under the
  supervision of a Physician. (SubCLINS 0004AA through

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  0004AD below).

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (Information CLIN Only)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0004AA

  	
   

  	
   

  	
   

  	
  5,000

  	
   

  	
  Each

  	
   

  	
  $10,000.00

  	
   

  	
  $50,000,000.00

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  HOSPITAL-BASED MRC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5,000 TED

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $50,000,000.00

  	
   

  



 

















 


W9113M-08-C-0028


 


Page 10 of 26


 


	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0004AB

  	
   

  	
   

  	
   

  	
  5,000

  	
   

  	
  Each

  	
   

  	
  $10,000.00

  	
   

  	
  $50,000,000.00

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  HOSPITAL-BASED MRC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5,000 TED

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $50,000,000.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0004AC

  	
   

  	
   

  	
   

  	
  5,000

  	
   

  	
  Each

  	
   

  	
  $10,000.00

  	
   

  	
  $50,000,000.00

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  HOSPITAL-BASED MRC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5,000 TED

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $50,000,000.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0004AD

  	
   

  	
   

  	
   

  	
  5,000

  	
   

  	
  Each

  	
   

  	
  $10,000.00

  	
   

  	
  $50,000,000.00

  	
   

  
	
  OPTION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  HOSPITAL-BASED MRC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FFP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5,000 TED

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  NET
  AMT

  	
   

  	
  $50,000,000.00

  	
   

  



 
















W9113M-08-C-0028


 


Page 11 of 26


 


Section C - Descriptions and Specifications


 


SECTION C


 


Contractor’s Statement of Work (SOW). See Section J,
List of Attachments, in response to Government’s Statement of Objectives (SOO).


 

















 


W9113M-08-C-0028


 


Page 12 of 26


 


Section D - Packaging and Marking


 


SECTION D


 


Packaging and Marking shall be in accordance with the
Contractor’s Statement of Work, as provided in response to the Government’s
Statement of Objectives (SOO).


 

















 


W9113M-08-C-0028


 


Page 13 of 26


 


Section E - Inspection and Acceptance


 


 


 


INSPECTION AND ACCEPTANCE TERMS


 


All Supplies/services will be inspected/accepted by
the government at Destination.


 


 


CLAUSES INCORPORATED BY REFERENCE


 


	
  52.246-2

  	
   

  	
  Inspection Of Supplies-Fixed Price

  	
   

  	
  AUG 1996

  
	
  52.246-3

  	
   

  	
  Inspection Of Supplies Cost-Reimbursement

  	
   

  	
  MAY 2001

  
	
  52.246-8

  	
   

  	
  Inspection Of Research And Development Cost
  Reimbursement

  	
   

  	
  MAY 2001

  
	
  52.246-16

  	
   

  	
  Responsibility For Supplies

  	
   

  	
  APR 1984

  
	
  252.246-7000

  	
   

  	
  Material Inspection And Receiving Report

  	
   

  	
  MAR 2003

  



 






 












W9113M-08-C-0028


 


Page 14 of 26


 


Section F
- Deliveries or Performance


 


DELIVERY
INFORMATION


 


	
  CLIN

  	
   

  	
  DELIVERY
  DATE

  	
   

  	
  QUANTITY

  	
   

  	
  SHIP
  TO ADDRESS

  	
   

  	
  UIC

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001

  	
   

  	
  N/A

  	
   

  	
  N/A

  	
   

  	
  N/A

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AA

  	
   

  	
  5
  yrs after Award

  	
   

  	
  N/A

  	
   

  	
  JPM-MITS

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  64
  Thomas Johnson Drive

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Frederick,
  MD 21702

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AB

  	
   

  	
  5
  yrs after option is exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AC

  	
   

  	
  Implemented
  6 mos of option exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AD

  	
   

  	
  Monthly
  after option exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AE

  	
   

  	
  Quarterly
  after option exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0001AF

  	
   

  	
  One
  yr after option is exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0003

  	
   

  	
  90
  days after option is exercised

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0004

  	
   

  	
  N/A

  	
   

  	
  N/A

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0004AA

  	
   

  	
  Within
  6 mos of exercise of option

  	
   

  	
  5,000

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0004AB

  	
   

  	
  Within
  6 mos of exercise of option

  	
   

  	
  5,000

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0004AC

  	
   

  	
  Within
  6 mos of exercise of option

  	
   

  	
  5,000

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  0004AD

  	
   

  	
  Within
  6 mos of exercise of option

  	
   

  	
  5,000

  	
   

  	
  Same
  as above

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


 


 


CLASSES
INCORPORATED BY REFERENCE


 


	
  52.242-15

  	
   

  	
  Stop-Work
  Order

  	
   

  	
  AUG
  1989

  
	
  52.242-15
  Alt I

  	
   

  	
  Stop-Work
  Order (Aug 1989) - Alternate I

  	
   

  	
  APR
  1984

  



 

















 


W9113M-08-C-0028


 


Page 15 of 26


 


 


	
  52.247-34

  	
   

  	
  F.O.B.
  Destination

  	
   

  	
  NOV
  1991

  



 
















W9113M-08-C-0028


 


Page 16 of 26


 


Section G - Contract Administration Data


 


PAYMENT/INVOICING


 


In accordance with DFARS Clause 252.232-7003, Electronic Submission of
Payment Requests, the contractor shall submit invoices electronically. A copy
of the invoice shall be submitted to the Contracting Officer’s Representative
(COR) listed below to facilitate the process for payment. Payment shall be made
by the Defense Finance and Accounting Office, upon acceptance by the COR.


 


Government Point of Contact:


 


US Army Space & Missile Defense Command


Attn: SMDC-RDCM-SB/Sandra O’Connell


64 Thomas Johnson Drive


Frederick, MD 21702


(301)619-2895


sandra.oconnell@us.army.mil


 


Contracting Officer’s Representative


 


MAJ Eric Wagar


64 Thomas Johnson Drive


Frederick, MD 21702


(301)619-8424


eric.wagar@us.army.mil


 


 


 


 


 


 


 


 


ACCOUNTING AND APPROPRIATION DATA


 


AA: 977040026017Y5YCM406038BP000255Y12YMMRW90GXK72270154YMMR12044008


AMOUNT: $4,253,390.80


CIN 000000000000000000000000000000: $4,253,390.80


 

















 


W9113M-08-C-0028


 


Page 17 of 26


 


Section H - Special Contract Requirements


 


SPECIAL REQUIREMENT


 


“The Sponsor shall seek permission from the FDA to re-label and use
consistency lot product as FDA-approved product and if allowed by the FDA, the
Government reserves the option to apply these doses in the fulfillment of the
production quantities to be obtained under the optional production SUBCLIN(s)
with the right to obtain a pro rata reduction in price under the exercised
production SUBCLIN(s) (taking into account the number of individual doses per
TED) using the effective unit price bid under the exercised production SUBCLIN(s)
as designated by the Government for the purposes of this special provision.”


 


 


CLAUSES INCORPORATED BY FULL TEXT


 


 


52.234-4   EARNED VALUE
MANAGEMENT SYSTEM (JUL 2006)


 


(a) The Contractor shall use an earned value management system (EVMS)
that has been determined by the Cognizant Federal Agency (CFA) to be compliant
with the guidelines in ANSI/EIA Standard - 748 (current version at the time of
award) to manage this contract. If the Contractor’s current EVMS has not been
determined compliant at the time of award, see paragraph (b) of this clause.
The Contractor shall submit reports in accordance with the requirements of this
contract.


 


(b) If, at the time of award, the Contractor’s EVM System has not been
determined by the CFA as complying with EVMS guidelines or the Contractor does
not have an existing cost/schedule control system that is compliant with the
guidelines in ANSI/EIA Standard - 748 (current version at time of award), the
Contractor shall—


 


(1) Apply the current system to the contract; and


 


(2) Take necessary actions to meet the milestones in the Contractor’s
EVMS plan approved by the Contracting Officer.


 


(c) The Government will conduct an Integrated Baseline Review (IBR). If
a pre-award IBR has not been conducted, a post award IBR shall be conducted as
early as practicable after contract award.


 


(d) The Contracting Officer may require an IBR at-


 


(1) Exercise of significant options; or


 


(2) Incorporation of major modifications.


 


(e) Unless a waiver is granted by the CFA, Contractor proposed EVMS
changes require approval of the CFA prior to implementation. The CFA will
advise the Contractor of the acceptability of such changes within 30 calendar
days after receipt of the notice of proposed changes from the Contractor. If
the advance approval requirements are waived by the CFA, the Contractor shall
disclose EVMS changes to the CFA at least 14 calendar days prior to the
effective date of implementation.


 


(f) The Contractor shall provide access to all pertinent records and
data requested by the Contracting Officer or a duly authorized representative
as necessary to permit Government surveillance to ensure that the EVMS
conforms, and continues to conform, with the performance criteria referenced in
paragraph (a) of this clause.


 


(g) The Contractor shall require the subcontractors specified below to
comply with the requirements of this clause: (Insert list of applicable
subcontractors.)


 

















 


W9113M-08-C-0028


 


Page 18 of 26


 


---------------------------


---------------------------


---------------------------


(End of clause)






 












 


W9113M-08-C-0028


 


Page 19 of 26


 


Section 1 - Contract Clauses


 


CLAUSES INCORPORATED BY REFERENCE


 


	
  52.202-1

  	
   

  	
  Definitions

  	
   

  	
  JUL 2004

  
	
  52.203-3

  	
   

  	
  Gratuities

  	
   

  	
  APR 1984

  
	
  52.203-5

  	
   

  	
  Covenant Against Contingent Fees

  	
   

  	
  APR 1984

  
	
  52.203-6

  	
   

  	
  Restrictions On Subcontractor Sales To The
  Government

  	
   

  	
  SEP 2006

  
	
  52.203-7

  	
   

  	
  Anti-Kickback Procedures

  	
   

  	
  JUL 1995

  
	
  52.203-8

  	
   

  	
  Cancellation, Rescission, and Recovery of Funds for
  Illegal or Improper Activity

  	
   

  	
  JAN 1997

  
	
  52.203-10

  	
   

  	
  Price Or Fee Adjustment For Illegal Or Improper
  Activity

  	
   

  	
  JAN 1997

  
	
  52.203-12

  	
   

  	
  Limitation On Payments To Influence Certain Federal
  Transactions

  	
   

  	
  SEP 2005

  
	
  52.204-4

  	
   

  	
  Printed or Copied Double-Sided on Recycled Paper

  	
   

  	
  AUG 2000

  
	
  52.204-7

  	
   

  	
  Central Contractor Registration

  	
   

  	
  JUL 2006

  
	
  52.209-6

  	
   

  	
  Protecting the Government’s Interest When
  Subcontracting With Contractors Debarred, Suspended, or Proposed for
  Debarment

  	
   

  	
  SEP 2006

  
	
  52.211-5

  	
   

  	
  Material Requirements

  	
   

  	
  AUG 2000

  
	
  52.215-2

  	
   

  	
  Audit and Records—Negotiation

  	
   

  	
  JUN 1999

  
	
  52.215-8

  	
   

  	
  Order of Precedence—Uniform Contract Format

  	
   

  	
  OCT 1997

  
	
  52.215-11

  	
   

  	
  Price Reduction for Defective Cost or Pricing Data—Modifications

  	
   

  	
  OCT 1997

  
	
  52.215-15

  	
   

  	
  Pension Adjustments and Asset Reversions

  	
   

  	
  OCT 2004

  
	
  52.215-19

  	
   

  	
  Notification of Ownership Changes

  	
   

  	
  OCT 1997

  
	
  52.219-6

  	
   

  	
  Notice Of Total Small Business Set-Aside

  	
   

  	
  JUN 2003

  
	
  52.219-8

  	
   

  	
  Utilization of Small Business Concerns

  	
   

  	
  MAY 2004

  
	
  52.219-14

  	
   

  	
  Limitations On Subcontracting

  	
   

  	
  DEC 1996

  
	
  52.222-3

  	
   

  	
  Convict Labor

  	
   

  	
  JUN 2003

  
	
  52.222-21

  	
   

  	
  Prohibition Of Segregated Facilities

  	
   

  	
  FEB 1999

  
	
  52.222-26

  	
   

  	
  Equal Opportunity

  	
   

  	
  MAR 2007

  
	
  52.222-35

  	
   

  	
  Equal Opportunity For Special Disabled Veterans,
  Veterans of the Vietnam Era, and Other Eligible Veterans

  	
   

  	
  SEP 2006

  
	
  52.222-36

  	
   

  	
  Affirmative Action For Workers With Disabilities

  	
   

  	
  JUN 1998

  
	
  52.223-6

  	
   

  	
  Drug-Free Workplace

  	
   

  	
  MAY 2001

  
	
  52.223-14

  	
   

  	
  Toxic Chemical Release Reporting

  	
   

  	
  AUG 2003

  
	
  52.225-13

  	
   

  	
  Restrictions on Certain Foreign Purchases

  	
   

  	
  FEB 2006

  
	
  52.227-11

  	
   

  	
  Patent Rights—Retention By The Contractor (Short
  Form)

  	
   

  	
  JUN 1997

  
	
  52.227-14

  	
   

  	
  Rights in Data—General

  	
   

  	
  JUN 1987

  
	
  52.227-23

  	
   

  	
  Rights to Proposal Data (Technical)

  	
   

  	
  JUN 1987

  
	
  52.228-7

  	
   

  	
  Insurance—Liability To Third Persons

  	
   

  	
  MAR 1996

  
	
  52.232-1

  	
   

  	
  Payments

  	
   

  	
  APR 1984

  
	
  52.232-17

  	
   

  	
  Interest

  	
   

  	
  JUN 1996

  
	
  52.232-20

  	
   

  	
  Limitation of Cost

  	
   

  	
  APR 1984

  
	
  52.232-23 Alt I

  	
   

  	
  Assignment of Claims (Jan 1986) - Alternate I

  	
   

  	
  APR 1984

  
	
  52.232-25

  	
   

  	
  Prompt Payment

  	
   

  	
  OCT 2003

  
	
  52.232-33

  	
   

  	
  Payment by Electronic Funds Transfer—Central
  Contractor Registration

  	
   

  	
  OCT 2003

  
	
  52.233-1

  	
   

  	
  Disputes

  	
   

  	
  JUL 2002

  
	
  52.233-3 Alt I

  	
   

  	
  Protest After Award (Aug 1996) - Alternate I

  	
   

  	
  JUN 1985

  
	
  52.242-1

  	
   

  	
  Notice of Intent to Disallow Costs

  	
   

  	
  APR 1984

  
	
  52.242-3

  	
   

  	
  Penalties for Unallowable Costs

  	
   

  	
  MAY 2001

  



 

















 


W9113M-08-C-0028


 


Page 20 of 26


 


	
  52.242-4

  	
   

  	
  Certification of Final Indirect Costs

  	
   

  	
  JAN 1997

  
	
  52.242-13

  	
   

  	
  Bankruptcy

  	
   

  	
  JUL 1995

  
	
  52.243-1 Alt V

  	
   

  	
  Changes--Fixed Price (Aug 1987) - Alternate V

  	
   

  	
  APR 1984

  
	
  52.243-2

  	
   

  	
  Changes--Cost Reimbursement

  	
   

  	
  AUG 1987

  
	
  52.244-5

  	
   

  	
  Competition In Subcontracting

  	
   

  	
  DEC 1996

  
	
  52.244-6

  	
   

  	
  Subcontracts for Commercial Items

  	
   

  	
  MAR 2007

  
	
  52.249-2

  	
   

  	
  Termination For Convenience Of The Government (Fixed-Price)

  	
   

  	
  MAY 2004

  
	
  52.249-6

  	
   

  	
  Termination (Cost Reimbursement)

  	
   

  	
  MAY 2004

  
	
  52.249-14

  	
   

  	
  Excusable Delays

  	
   

  	
  APR 1984

  
	
  52.253-1

  	
   

  	
  Computer Generated Forms

  	
   

  	
  JAN 1991

  
	
  252.203-7001

  	
   

  	
  Prohibition On Persons Convicted of Fraud or Other
  Defense-Contract-Related Felonies

  	
   

  	
  DEC 2004

  
	
  252.204-7004 Alt A

  	
   

  	
  Central Contractor Registration (52.204-7) Alternate
  A

  	
   

  	
  NOV 2003

  
	
  252209-7004

  	
   

  	
  Subcontracting With Firms That Are Owned or
  Controlled By The Government of a Terrorist Country

  	
   

  	
  DEC 2006

  
	
  252.211-7003

  	
   

  	
  Item Identification and Valuation

  	
   

  	
  JUN 2005

  
	
  252.215-7000

  	
   

  	
  Pricing Adjustments

  	
   

  	
  DEC 1991

  
	
  252.232-7003

  	
   

  	
  Electronic Submission of Payment Requests

  	
   

  	
  MAR 2007

  
	
  252.235-7010

  	
   

  	
  Acknowledgment of Support and Disclaimer

  	
   

  	
  MAY 1995

  
	
  252.235-7011

  	
   

  	
  Final Scientific or Technical Report

  	
   

  	
  NOV 2004

  
	
  252.243-7002

  	
   

  	
  Requests for Equitable Adjustment

  	
   

  	
  MAR 1998

  
	
  252.244-7000

  	
   

  	
  Subcontracts for Commercial Items and Commercial
  Components (DoD Contracts)

  	
   

  	
  JAN 2007

  
	
  252.247-7023

  	
   

  	
  Transportation of Supplies by Sea

  	
   

  	
  MAY 2002

  
	
  252.247-7024

  	
   

  	
  Notification Of Transportation Of Supplies By Sea

  	
   

  	
  MAR 2000

  



 


 


CLAUSES
INCORPORATED BY FULL TEXT


 


52.216-7   ALLOWABlE COST AND PAYMENT (DEC 2002)


 


(a)
Invoicing.


 


(I)
The Government will make payments to the Contractor when requested as work
progresses, but (except for small business concerns) not more often than once
every 2 weeks, in amounts determined to be allowable by the Contracting Officer
in accordance with Federal Acquisition Regulation (FAR) subpart 31.2 in effect
on the date of this contract and the terms of this contract. The Contractor may
submit to an authorized representative of the Contracting Officer, in such form
and reasonable detail as the representative may require, an invoice or voucher
supported by a statement of the claimed allowable cost for performing this
contract.


 


(2)
Contract financing payments are not subject to the interest penalty provisions
of the Prompt Payment Act. Interim payments made prior to the final payment
under the contract are contract financing payments, except interim payments if
this contract contains Alternate I to the clause at 52.232-25.


 


(3)
The designated payment office will make interim payments for contract financing
on the 30th (Contracting Officer insert day as prescribed by agency head; if
not prescribed, insert “30th”) day after the designated billing office receives
a proper payment request.


 


In
the event that the Government requires an audit or other review of a specific
payment request to ensure compliance with the terms and conditions of the
contract, the designated payment office is not compelled to make payment by the
specified due date.


 






 












W9113M-08-C-0028


 


Page 21 of 26


 


(b) Reimbursing costs. (1) For the purpose of reimbursing allowable
costs (except as provided in subparagraph (b)(2) of the clause, with respect to
pension, deferred profit sharing, and employee stock ownership plan contributions),
the term “costs” includes only—


 


(i) Those recorded costs that, at the time of the request for
reimbursement, the Contractor has paid by cash, check, or other form of actual
payment for items or services purchased directly for the contract;


 


(ii) When the Contractor is not delinquent in paying costs of contract
performance in the ordinary course of business, costs incurred, but not
necessarily paid, for—


 


(A) Supplies and services purchased directly for the contract and
associated financing payments to subcontractors, provided payments determined
due will be made—


 


(1) In accordance with the terms and conditions of a subcontract or
invoice; and


 


(2) Ordinarily within 30 days of the submission of the Contractor’s
payment request to the Government;


 


(B) Materials issued from the Contractor’s inventory and placed in the
production process for use on the contract;


 


(C) Direct labor;


 


(D) Direct travel;


 


(E) Other direct in-house costs; and


 


(F) Properly allocable and allowable indirect costs, as shown in the
records maintained by the Contractor for purposes of obtaining reimbursement
under Government contracts; and


 


(iii) The amount of financing payments that have been paid by cash,
check, or other forms of payment to subcontractors.


 


(2) Accrued costs of Contractor contributions under employee pension
plans shall be excluded until actually paid unless—


 


(i) The Contractor’s practice is to make contributions to the
retirement fund quarterly or more frequently; and


 


(ii) The contribution does not remain unpaid 30 days after the end of
the applicable quarter or shorter payment period (any contribution remaining
unpaid shall be excluded from the Contractor’s indirect costs for payment
purposes).


 


(3) Notwithstanding the audit and adjustment of invoices or vouchers
under paragraph (g) of this clause, allowable indirect costs under this
contract shall be obtained by applying indirect cost rates established in
accordance with paragraph (d) of this clause.


 


(4) Any statements in specifications or other documents incorporated in
this contract by reference designating performance of services or furnishing of
materials at the Contractor’s expense or at no cost to the Government shall be
disregarded for purposes of cost-reimbursement under this clause.


 


(c) Small business concerns. A small business concern may receive more
frequent payments than every 2 weeks.


 


(d) Final indirect cost rates. (1) Final annual indirect cost rates and
the appropriate bases shall be established in accordance with Subpart 42.7 of
the Federal Acquisition Regulation (FAR) in effect for the period covered by
the indirect cost rate proposal.


 

















 


W9113M-08-C-0028


 


Page 22 of 26


 


(2)(i) The Contractor shall submit an adequate final indirect cost rate
proposal to the Contracting Officer (or cognizant Federal agency official) and
auditor within the 6-month period following the expiration of each of its
fiscal years. Reasonable extensions, for exceptional circumstances only, may be
requested in writing by the Contractor and granted in writing by the Contracting
Officer. The Contractor shall support its proposal with adequate supporting
data.


 


(ii) The proposed rates shall be based on the Contractor’s actual cost
experience for that period. The appropriate Government representative and the
Contractor shall establish the final indirect cost rates as promptly as
practical after receipt of the Contractor’s proposal.


 


(3) The Contractor and the appropriate Government representative shall
execute a written understanding setting forth the final indirect cost rates.
The understanding shall specify (i) the agreed-upon final annual indirect cost
rates, (ii) the bases to which the rates apply, (iii) the periods for which the
rates apply, (iv) any specific indirect cost items treated as direct costs in
the settlement, and (v) the affected contract and/or subcontract, identifying
any with advance agreements or special terms and the applicable rates. The
understanding shall not change any monetary ceiling, contract obligation, or
specific cost allowance or disallowance provided for in this contract. The
understanding is incorporated into this contract upon execution.


 


(4) Failure by the parties to agree on a final annual indirect cost
rate shall be a dispute within the meaning of the Disputes clause.


 


(5) Within 120 days (or longer period if approved in writing by the
Contracting Officer) after settlement of the final annual indirect cost rates
for all years of a physically complete contract, the Contractor shall submit a
completion invoice or voucher to reflect the settled amounts and rates.


 


(6)(i) If the Contractor fails to submit a completion invoice or
voucher within the time specified in paragraph (d)(5) of this clause, the
Contracting Officer may—


 


(A) Determine the amounts due to the Contractor under the contract; and


 


(B) Record this determination in a unilateral modification to the
contract.


 


(ii) This determination constitutes the final decision of the
Contracting Officer in accordance with the Disputes clause.


 


(e) Billing rates. Until final annual indirect cost rates are
established for any period, the Government shall reimburse the Contractor at
billing rates established by the Contracting Officer or by an authorized
representative (the cognizant auditor), subject to adjustment when the final
rates are established. These billing rates—


 


(1) Shall be the anticipated final rates; and


 


(2) May be prospectively or retroactively revised by mutual agreement,
at either party’s request, to prevent substantial overpayment or underpayment.


 


(f) Quick-closeout procedures. Quick-closeout procedures are applicable
when the conditions in FAR 42.708(a) are satisfied.


 


(g) Audit. At any time or times before final payment, the Contracting
Officer may have the Contractor’s invoices or vouchers and statements of cost
audited. Any payment may be (1) Reduced by amounts found by the Contracting
Officer not to constitute allowable costs or (2) Adjusted for prior
overpayments or underpayments.


 


(h) Final payment. (1) Upon approval of a completion invoice or voucher
submitted by the Contractor in accordance with paragraph (d)(4) of this clause,
and upon the Contractor’s compliance with all terms of this contract, the
Government shall promptly pay any balance of allowable costs and that part of
the fee (if any) not previously paid.


 
















 


W9113M-08-C-0028


 


Page 23 of 26


 


(2) The Contractor shall pay to the Government any refunds, rebates,
credits, or other amounts (including interest, if any) accruing to or received
by the Contractor or any assignee under this contract, to the extent that those
amounts are properly allocable to costs for which the Contractor has been
reimbursed by the Government. Reasonable expenses incurred by the Contractor
for securing refunds, rebates, credits, or other amounts shall be allowable
costs if approved by the Contracting Officer. Before final payment under this
contract, the Contractor and each assignee whose assignment is in effect at the
time of final payment shall execute and deliver—


 


(i) An assignment to the Government, in form and substance satisfactory
to the Contracting Officer, of refunds, rebates, credits, or other amounts
(including interest, if any) properly allocable to costs for which the
Contractor has been reimbursed by the Government under this contract; and


 


(ii) A release discharging the Government, its officers, agents, and
employees from all liabilities, obligations, and claims arising out of or under
this contract, except—


 


(A) Specified claims stated in exact amounts, or in estimated amounts
when the exact amounts are not known;


 


(B) Claims (including reasonable incidental expenses) based upon
liabilities of the Contractor to third parties arising out of the performance
of this contract; provided, that the claims are not known to the Contractor on
the date of the execution of the release, and that the Contractor gives notice
of the claims in writing to the Contracting Officer within 6 years following
the release date or notice of final payment date, whichever is earlier; and


 


(C) Claims for reimbursement of costs, including reasonable incidental
expenses, incurred by the Contractor under the patent clauses of this contract,
excluding, however, any expenses arising from the Contractor’s indemnification
of the Government against patent liability.


 


(End of clause)


 


 


 


52.216-10 INCENTIVE FEE (MAR 1997)


 


(a) General. The Government shall pay the Contractor for performing
this contract a fee determined as provided in this contract.


 


(b) Target cost and target fee. The target cost and target fee
specified in the Schedule are subject to adjustment if the contract is modified
in accordance with paragraph (d) below.


 


(1) “Target cost,” as used in this contract, means the estimated cost
of this contract as initially negotiated, adjusted in accordance with paragraph
(d) below.


 


(2) “Target fee,” as used in this contract, means the fee initially
negotiated on the assumption that this contract would be performed for a cost
equal to the estimated cost initially negotiated, adjusted in accordance with
paragraph (d) below.


 


(c) Withholding of payment. Normally, the Government shall pay the fee
to the Contractor as specified in the Schedule. However, when the Contracting
Officer considers that performance or cost indicates that the Contractor will
not achieve target, the Government shall pay on the basis of an appropriate
lesser fee. When the Contractor demonstrates that performance or cost clearly
indicates that the Contractor will earn a fee significantly above the target
fee, the Government may, at the sole discretion of the Contracting Officer, pay
on the basis of an appropriate higher fee. After payment of 85 percent of the
applicable fee, the Contracting Officer may withhold further payment of fee
until a reserve is set aside in an amount that the Contracting Officer
considers necessary to protect the Government’s interest. This reserve shall
not exceed 15 percent of the applicable fee or $100,000, whichever is less. The
Contracting Officer shall release 75 percent of all fee withholds under this
contract after receipt of the certified


 

















 


W9113M-08-C-0028


 


Page 24 of 26


 


final indirect cost rate proposal covering the year of physical
completion of this contract, provided the Contractor has satisfied all other
contract terms and conditions, including the submission of the final patent and
royalty reports, and is not delinquent in submitting final vouchers on prior
years’ settlements. The Contracting Officer may release up to 90 percent of the
fee withholds under this contract based on the Contractor’s past performance
related to the submission and settlement of final indirect cost rate proposals.


 


(d) Equitable adjustments. When the work under this contract is
increased or decreased by a modification to this contract or when any equitable
adjustment in the target cost is authorized under any other clause, equitable
adjustments in the target cost, target fee, minimum fee, and maximum fee, as
appropriate, shall be stated in a supplemental agreement to this contract.


 


(e) Fee payable. (1) The fee payable under this contract shall be the
target fee increased by 30           .
[Contracting Officer insert Contractor’s participation] cents for every dollar
that the total allowable cost is less than the target cost or decreased by 30
[Contracting Officer insert Contractor’s participation] cents for every dollar
that the total allowable cost exceeds the target cost. In no event shall the
fee be greater than 20 [Contracting Officer insert percentage] percent or less
than . . . . . 0 . . . . .[Contracting Officer insert percentage] percent of
the target cost.


 


(2) The fee shall be subject to adjustment, to the extent provided in
paragraph (d) above, and within the minimum and maximum fee limitations in
subparagraph (1) above, when the total allowable cost is increased or decreased
as a consequence of (i) payments made under assignments or (ii) claims excepted
from the release as required by paragraph (h)(2) of the Allowable Cost and
Payment clause.


 


(3) If this contract is terminated in its entirety, the portion of the
target fee payable shall not be subject to an increase or decrease as provided
in this paragraph. The termination shall be accomplished in accordance with
other applicable clauses of this contract.


 


(4) For the purpose of fee adjustment, “total allowable cost” shall not
include allowable costs arising out of—


 


(i) Any of the causes covered by the Excusable Delays clause to the
extent that they are beyond the control and without the fault or negligence of
the Contractor or any subcontractor;


 


(ii) The taking effect, after negotiating the target cost, of a
statute, court decision, written ruling, or regulation that results in the
Contractor’s being required to pay or bear the burden of any tax or duty or
rate increase in a tax or duty;


 


(iii) Any direct cost attributed to the Contractor’s involvement in
litigation as required by the Contracting Officer pursuant to a clause of this
contract, including furnishing evidence and information requested pursuant to
the Notice and Assistance Regarding Patent and Copyright Infringement clause;


 


(iv) The purchase and maintenance of additional insurance not in the
target cost and required by the Contracting Officer, or claims for
reimbursement for liabilities to third persons pursuant to the Insurance
Liability to Third Persons clause;


 


(v) Any claim, loss, or damage resulting from a risk for which the
Contractor has been relieved of liability by the Government Property clause; or


 


(vi) Any claim, loss, or damage resulting from a risk defined in the
contract as unusually hazardous or as a nuclear risk and against which the
Government has expressly agreed to indemnify the Contractor.


 


(5) All other allowable costs are included in “total allowable cost”
for fee adjustment in accordance with this paragraph (e), unless otherwise
specifically provided in this contract.


 


(f) Contract modification. The total allowable cost and the adjusted
fee determined as provided in this clause shall be evidenced by a modification
to this contract signed by the Contractor and Contracting Officer.


 
















 


W9113M-08-C-0028


 


Page 25 of 26


 


(g) Inconsistencies. In the event of any language inconsistencies
between this clause and provisioning documents or Government options under this
contract, compensation for spare parts or other supplies and services ordered
under such documents shall be determined in accordance with this clause.


 


(End of clause)


 


 


 


52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)


 


The Government may increase the quantity of supplies called for in the
Schedule at the unit price specified. The Contracting Officer may exercise the
option by written notice to the Contractor within 60 days. Delivery of
the added items shall continue at the same rate as the like items called for
under the contract, unless the parties otherwise agree.


 


(End of clause)


 


 


 


52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM (OCT 2004)


 


United States law will apply to resolve any claim of breach of this
contract.


 


(End of clause)


 

















 


W9113M-08-C-0028


 


Page 26 of 26


 


Section J - List of Documents, Exhibits and Other Attachments


 


LIST OF ATTACHMENTS


	
  No.

  	
   

  	
  Description

  	
   

  	
  Date

  	
   

  	
  No Pages

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  I

  	
   

  	
  Contractor’s Statement of Work

  	
   

  	
  Apr 23, 2007

  	
   

  	
  15

  
	
   

  	
   

  	
   

  	
   

  	
  (with revisions dated August 10, 2007)

  



 


 


 


Exhibits — Contract Data Requirements List (CDRL) DD 1423


 


	
  A001

  	
   

  	
  Contractor’s Progress, Status, and Management Report

  
	
  A002

  	
   

  	
  Contracts Funds Status Report (CFSR)

  
	
  A003

  	
   

  	
  Contract Work Breakdown Structure (CWBS)

  
	
  A004

  	
   

  	
  Integrated Master Schedule (IMS)

  
	
  A005

  	
   

  	
  Contract Performance Report (CPR)

  
	
  A006

  	
   

  	
  Regulatory Submission File

  
	
  A007

  	
   

  	
  Technical Data Package (TDP)

  
	
  A008

  	
   

  	
  Interim Program Review MS Powerpoint Presentation

  



 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AA, 0001AB

  	
  B. EXHIBIT

  A001

  	
  C. CATEGORY:

       TDP          
  TM            OTHER
   X                                         

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A001

  	
  2. TITLE OF DATA ITEM

  Contractor’s Progress,
  Status and Management Report

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)

  DI-MGMT-80227

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.4.4

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  Yes

  	
     REQUIRED

  	
  Monthly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT 

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  This report shall be submitted monthly. The Contractor’s Progress, Status,
  and Management Report indicates the progress of the work, status of the
  program and of the assigned tasks. The report shall include cost updates, and
  information relating to existing or potential problem areas and proposed
  action to resolve the problems. (A draft report is due on the first Tuesday
  of the month. Issues and questions from the draft report will be discussed at
  a teleconference to be conducted on the second Tuesday of the month. A final
  report, with incorporated changes, corrections, and minutes of the
  teleconference, are due within a week following the teleconference.)

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems 

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE

  

  27 NOV 2007

  	
  I. APPROVED BY

  

  	
  J. DATE

  

  NOV 27 2007

  	
   

  	
   

  
																			



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                        Page
         of          
Pages


                                                                                                                                                                                                                                 Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AD

  	
  B. EXHIBIT

  A002

  	
  C. CATEGORY:

       
  TDP           TM           
  OTHER   X                                               

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A002

  	
  2. TITLE OF DATA ITEM

  Contract Funds Status
  Report (CFSR)

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)

  DI-MGMT-81468

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.4.5

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL
  PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  Yes

  	
      REQUIRED

  	
  Quarterly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  A draft CFSR (DD
  Form 1568) is due on the first Tuesday of the first month of a fiscal year
  quarter (federal fiscal year begins Oct 1). Issues and questions from the
  draft report shall be discussed at a teleconference on the second Tuesday of
  the month. This teleconference may be the same as for the Contractor’s
  Progress, Status and Management Report, A001. A final report, with
  incorporated changes, corrections, and minutes of the teleconference, are due
  five working days following the teleconference.

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE

  

  27 NOV 2007

  	
  I. APPROVED BY

  

  	
  J. DATE

  

  NOV 27 2007

  	
   

  	
   

  
																			



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                        Page
          of          
Pages


                                                                                                                                                                                                                                 Adobe
Professional 7.0


 






 












 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
   

  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searcing existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AA, 0001AB

  	
  B. EXHIBIT

  A003

  	
  C. CATEGORY:

       TDP          
  TM           
  OTHER X                                                       

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A003

  	
  2. TITLE OF DATA ITEM

  Contract Work Breakdown
  Structure (CWBS)

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)

  DI-MGMT-81334B

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.3.3

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  Yes

  	
      REQUIRED

  	
  Monthly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  The CWBS and the CWBS dictionary shall be updated quarterly. The revised CWBS
  and CWBS dictionary are due on the first Tuesday of the first month. Issues
  and questions from the CWBS will be discussed at a teleconference to be
  conducted on the second Tuesday of the month. This teleconference may be the
  same as for the Contractor’s Progress, Status and Management Report, A001. A
  final report, with incorporated changes, corrections, and minutes of the teleconference,
  are due within a week following the teleconference. The Offeror shall extend
  the selected CWBS elements to define the complete contract scope. The CWBS
  will be to a depth and breadth necessary to accurately describe the Offeror’s
  proposed effort, to a minimum of Level 4. The CWBS shall be structured to
  correlate with the Government’s Statement of Objectives.

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702.

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE



  27 NOV 2007

  	
  I. APPROVED BY


  	
  J. DATE

   

  NOV 27 2007

  	
   

  	
   

  
																				



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                         Page
         of          
Pages


                                                                                                                                                                                                                                 Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
   

  	
  Form Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection at information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AA, 0001AB

  	
  B. EXHIBIT

  A004

  	
  C. CATEGORY:

       TDP          
  TM           
  OTHER X                                                         

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A004

  	
  2. TITLE OF DATA ITEM

  Integrated Master
  Schedule (IMS)

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)

  DI-MGMT-81650

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.3.3

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  YES

  	
     REQUIRED

  	
  Monthly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  NO

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  The IMS shall be updated monthly. The revised IMS is due on the first Tuesday
  of the month. Issues and questions from the IMS draft report shall be
  discussed at a teleconference on the second Tuesday of the month. This
  teleconference may be the same as for the Contractor’s progress, Status and
  Management Report, A001. The IMS shall be structured to correlate with the
  Statement of Objectives (SOO). A final report, with incorporated changes,
  corrections, and minutes of the teleconference, are due within a week
  following the teleconference.

   

  Address to: Joint
  Product Manager-Medical Identification Treatment Systems

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE

  

  27 NOV 2007

  	
  I. APPROVED BY


  	
  J. DATE

   

  NOV 27 2007

  	
   

  	
   

  
																				



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                         Page
         of          
Pages


                                                                                                                                                                                                                                 Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  date sources, gathering and maintaining the date needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate {0704-0188}. Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it do not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AD

  	
  B. EXHIBIT

  A005

  	
  C. CATEGORY:

       TDP            
  TM            
  OTHER  X                                                

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A005

  	
  2. TITLE OF DATA ITEM

  Contract Performance
  Report (CPR)

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)

  DI-MGMT-81466A

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.4.4

  	
  6. REQUIRING OFFICE

  MITS  JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL
  PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  YES

  	
      REQUIRED

  	
  Monthly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  NO

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  The CPR shall be
  submitted monthly. The CPR shall contain Formats 1-5 containing data for
  measuring Contractors’ cost and schedule performance. These reports shall be
  integrated with the CWBS (A003) and IMS (A004). A draft report is due on the
  first Tuesday of the month. Issues and questions from the draft report will
  be discussed at a teleconference to be conducted on the second Tuesday of the
  month. This teleconference may be the same as for the Contractor’s Progress,
  Status and management Report (A001). A final report, with incorporated
  changes, corrections, and minutes of the teleconference, are due within a
  week following the teleconference.

   

  Address to: Joint
  Product Manager-Medical Identification Treatment Systems 

                      (JPM-MITS) 

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE

  

  27 NOV 2007

  	
  I. APPROVED BY

  

  	
  J. DATE

  

  NOV 27 2007

  	
   

  	
   

  
																			



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                         Page
          of          
Pages


                                                                                                                                                                                                                                 Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  date sources, gathering and maintaining the date needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection at information if it down not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AA, 0001AB

  	
  B. EXHIBIT

  A006

  	
  C. CATEGORY:

       TDP
             TM            
  OTHER  X                                              

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A006

  	
  2. TITLE OF DATA ITEM

  Regulatory Submission
  File

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquinition Document No.)

  DI-MGMT-81466A

  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.3.1

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL
  PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  YES

  	
      REQUIRED

  	
  As Required

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  This data package shall contain copies of Investigational New Drug (IND)
  submissions, annual reports, New Drug Application (NDA) submissions, and
  other communications with the U.S. Food and drug Administration (FDA). The
  data package shall also contain all FDA-initiated correspondence, to include
  meeting minutes, requests for additional information, etc. The preferred
  format for these regulatory documents is electronic. The Contractor shall
  send copies of regulatory documents to the Government at the same time they
  are sent to the FDA. Copies of regulatory communications received from the
  FDA shall be sent within three to five working days of receipt.

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems 

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE

  

  27 NOV 2007

  	
  I. APPROVED BY

  

  	
  J. DATE

  

  NOV 27 2007

  	
   

  	
   

  
																			



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                              Page
          of          
Pages


                                                                                                                                                                                                                                    Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
   

  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense. Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AF

  	
  B. EXHIBIT

  A007

  	
  C. CATEGORY:

  TDP          
  TM           
  OTHER X                                                       

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A007

  	
  2. TITLE OF DATA ITEM

  Technical Data Package
  (TDP)

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)



  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.3.4

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  Yes

  	
      REQUIRED

  	
  One Time

  	
  TBD

  	
   

  	
  b. COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  The Government shall direct preparation of a Technical Data Package that
  includes all necessary documentation and data for the Government, or its
  designee, to continue the development or production of the product. At any
  time the product ceases to be marketed and is retired or in the event the
  Contractor defaults and fails to remedy said default before or after
  approval, the Contractor shall transfer the TDP to the Government or its
  designee. The Contractor shall also assist in the technical transfer as
  determined by the Government. The draft TDP shall be grammatically and
  typographically correct. The corrected TDP with recommended changes made, is
  due within ten working days after receipt of the Government’s comments.

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems 

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE



  27 NOV 2007

  	
  I. APPROVED BY


  	
  J. DATE

   

  NOV 27 2007

  	
   

  	
   

  
																				



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                             Page
         of          
Pages


                                                                                                                                                                                                                                    Adobe
Professional 7.0


 
















 


	
  CONTRACT
  DATA REQUIREMENTS LIST

  (1 Data
  Item)



  	
  Form
  Approved

  OMB No. 0704-0188



  	 

	
  The public reporting
  burden for this collection of information is estimated to average 110 hours
  per response, including the time for reviewing instructions, searching existing
  data sources, gathering and maintaining the data needed, and completing and
  reviewing the collection of information. Send comments regarding this burden
  estimate or any other aspect of this collection of information, including
  suggestions for reducing the burden, to the Department of Defense, Executive
  Services Directorate (0704-0188). Respondents should be aware that
  notwithstanding any other provision of law, no person shall be subject to any
  penalty for failing to comply with a collection of information if it does not
  display a currently valid OMB control number. Please do not return your form
  to the above organization. Send completed form to the Government Issuing
  Contracting Officer for the Contract/PR No. listed in Block E.

  	 

	
  A. CONTRACT LINE ITEM NO.

  0001AA, 0001AB

  	
  B. EXHIBIT

  A008

  	
  C. CATEGORY:

  TDP          
  TM           
  OTHER X                                                             

  	 

	
  D. SYSTEM/ITEM

  Reports

  	
  E. CONTRACT/PR NO.

  W9113M-08-C-0028

  	
  F. CONTRACTOR

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1. DATA ITEM NO.

  A008

  	
  2. TITLE OF DATA ITEM

  Interim Program Review MS PowerPoint Presentation

  	
  3. SUBTITLE

  	
   

  	
  17. PRICE GROUP

  
	
  4. AUTHORITY (Data Acquisition Document No.)



  	
  5. CONTRACT REFERENCE

  C SOW paragraph
  C.4.5

  	
  6. REQUIRING OFFICE

  MITS JPMO

  	
   

  	
  18. ESTIMATED

        TOTAL PRICE

  
	
  7. DD 250 REQ

  	
  9. DIST STATEMENT

  	
  10. FREQUENCY

  	
  12. DATE OF FIRST SUBMISSION

  	
  14.                        DISTRIBUTION

  	
   

  	
   

  
	
  Yes

  	
      REQUIRED

  	
  Quarterly

  	
  TBD

  	
   

  	
  b.   COPIES

  	
   

  	
   

  
	
  8. APP CODE

  	
   

  	
  11. AS OF DATE

  	
  13. DATE OF SUBSEQUENT

  	
        a.
  ADDRESSEE

  	
  Draft

  	
  Final

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
        SUBMISSION

  	
   

  	
  Reg

  	
  Repro

  	
   

  	
   

  
	
   

  	
  No

  	
  Award Date

  	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16. REMARKS

  A draft
  Microsoft PowerPoint presentation shall be submitted to the Government by the
  Contractor or Subcontractor ten days prior to the quarterly Interim Program
  Review. This gives the Government the opportunity to review the slides and
  present any changes to be made prior to the review with JPM-MITS.

  

  Address to: Joint Product Manager-Medical Identification Treatment Systems 

                      (JPM-MITS)
  

                      64
  Thomas Johnson Dr.

                      Frederick,
  MD 21702

   

  	
  MITS/COR

  	
  2

  	
  3

  	
   

  	
   

  	
   

  
	
  See address in

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    block 16

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15. TOTAL 

  	
  2

  	
  3

  	
  0

  	
   

  	
   

  
	
  G. PREPARED BY

  E. J. Wagar

  MAJ, U.S. Army

  	
  H. DATE



  27 NOV 2007

  	
  I. APPROVED BY


  	
  J. DATE



  NOV 27 2007

  	
   

  	
   

  
																			



DD FORM 1423-1, FEB 2001                                                    PREVIOUS
EDITION MAY BE USED.                                                             Page
         of          
Pages


                                                                                                                                                                                                                                    Adobe
Professional 7.0


 
















 


	
  

  	
   

  	
  Attachment 1

  W9113M-08-C-0028

  Page 1 of 15

  



 


 


Solicitation Number: W9113M-07-R-0002










2.1                               Statement of Work (SOW)


 


Osiris Therapeutics, Inc. is a stem cell company manufacturing
adult-derived human mesenchymal stem cells (hMSCs) intended for “off-the-shelf”
therapeutic use to repair tissue damage and reduce tissue inflammation. The
lead stem cell product, ProchymalTM, is currently being tested in
two Phase III clinical trials to treat Gastrointestinal (GI) Diseases (Graft
versus Host Disease (GvHD) and Crohn’s Disease). Both preclinical and clinical
evidence suggest that ProchymalTM could be used to repair GI damage
from Acute Radiation Syndrome (ARS) to restore the anatomic integrity and
normal physiological functioning of the GI tract. Data suggest that ProchymalTM
may impact overall survival because it is a cellular product that can repair
tissue damage resulting from cell death, which is the hallmark of radiation
exposure.


 


Osiris plans to develop a post-exposure
Medical Radiation Countermeasure (MRC) that will increase survival and decrease
incapacity of military forces so that these forces can maintain operational
effectiveness within a contaminated area following radiation exposure,
irrespective of radiation source. Osiris plans to develop the hMSCs product for
treatment of GI-ARS through product approval/licensure with FDA and sell
quantities of the MRC to the government sufficient to achieve the Initial
Operating Capability (IOC).


 


Osiris has already met several of the work items
listed in the Statement of Objectives. The work that has been completed has
been included in this SOW for completeness; this completed work is indicated by
italicized text.


 


INSERTED TEXT


 


A summary of Osiris’ progress in completing sections
C.3.1 (CLIN 0001AA) and C.3.2 (CLIN 0001AB) of the Statement of Work is
provided in the table below.










August 10, 2007


Use or disclosure
of data contained on this sheet is subject to the restriction on the title page
of this proposal.


 


2.1-1

















 


	
  

  	
   

  	
  Attachment 1

  W9113M-08-C-0028

  Page 2 of 15

  



 


 


Solicitation Number: W9113M-07-R-0002






 


INSERTED TABLE


 


 


	
   Solicitation Number W9113M-07-R-0002

   CLIN 0001AA

   	
   SOO
  Paragraph

   	
   SOO
   Element

   	
   Completion
  Date

   
	
  C.3.1

  	
  IND
  Submission

  	
  4Q
  2007

  
	
  C.3.1.1

  	
  Development &
  Qualification of Small Scale GMP Manufacturing Process

  	
  COMPLETE

  
	
  C.3.1.2

  	
  Manufacture
  GMP MRC for Toxicology Studies & Clinical Trial

  	
  COMPLETE

  
	
  C.3.1.3

  	
  Develop
  Product Formulations Suitable for Humans

  	
  COMPLETE

  
	
  C.3.1.4

  	
  Develop &
  Validate Product Characterization & Lot Release Assays for Large-Scale
  Manufacturing Process

  	
  COMPLETE

  
	
  C.3.1.5

  	
  Conduct
  GLP Acute Toxicology Studies

  	
  COMPLETE

  
	
  C.3.1.6

  	
  Carry
  Out Efforts to Ensure Successful Submission of IND Application

  	
  4Q
  2007

  
	
  C.3.1.7

  	
  Support
  Submission of EUA

  	
  2Q
  2008

  
	
  C.3.1.8

  	
  Conduct
  Phase I Clinical Trial

  	
  COMPLETE

  
	
  C.3.1.9

  	
  Store
  Phase I Product for Two Years

  	
  COMPLETE

  
	
  C.3.1.10

  	
  Carry
  Out Stability Testing for Phase I Product

  	
  COMPLETE

  
	
  CLIN 0001AB

  	
  SOO
  Paragraph

  	
  SOO
  Element

  	
  Completion
  Date

  
	
  C.3.2

  	
  Conduct
  Activities Leading to FDA Approval

  	
  3Q
  2010

  
	
  C.3.2.1

  	
  Qualification
  and Validation of Large-Scale GMP Manufacturing Process

  	
  COMPLETE

  
	
  C.3.2.2

  	
  Demonstrate
  Lot Consistency for Large-Scale  GMP
  Manufacturing Process

  	
  COMPLETE

  
	
  C.3.2.3

  	
  Refine
  Product Formulation and Develop Delivery System Suitable for Human Use

  	
  COMPLETE

  
	
  C.3.2.4

  	
  Develop &
  Validate Product Characterization & Lot Release Assays for
  Large-Scale Manufacturing Process

  	
  COMPLETE

  
	
  C.3.2.5

  	
  Active
  Pharmaceutical Ingredient Stability Testing

  (2yr
  Interim Report)

  	
  3Q
  2009

  
	
  C.3.2.6

  	
  GMP
  Formulated Product Stability Testing for Shelf Life

  (2yr
  Interim Report)

  	
  3Q
  2009

  
	
  C.3.2.7

  	
  Operational
  Storage / Military Scenario Stability Studies

  	
  4Q
  2009

  
	
  C.3.2.8

  	
  Nonclinical
  Studies to Support BLA Submission

  	
  COMPLETE

  
	
  C.3.2.9

  	
  GLP
  Animal Efficacy Studies

  	
  2Q
  2009

  
	
  C.3.2.10

  	
  GCP
  Phase II Safety Clinical Study

  	
  COMPLETE

  
	
  C.3.2.11

  	
  BLA
  Submission

  	
  1Q
  2010

  
	
  C.3.2.12

  	
  Delivery
  of 1 TED of FDA-Approved MRC

  	
  4Q
  2010

  



 










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Osiris shall be the sponsor and remain the
sponsor for so long as the product is marketed for the gastrointestinal
component of ARS (GI-ARS). If the product ceases to be marketed for GI-ARS and
in the event that Osiris defaults and fails to remedy said default, the
sponsorship shall be transferred to the government to include all data related
to GI-ARS product development and manufacture, as follows: upon written request
from the Contracting Officer, Osiris agrees to immediately request approval, in
writing, from FDA to effectuate transfer of the Investigational New Drug (IND)
application and/or New Drug Application (NDA) Biological License Application
(BLA) to the Government or its designee, and Osiris agrees to use its best
efforts in obtaining such approval, including but not limited to, the execution
of any and all documents which are reasonably necessary to effectuate such a transfer.
In the case of where Osiris would be required to transfer sponsorship to the
government, the government shall only use the technology for GI-ARS and shall
not use the technology for other indications. All such transfers of technical
data that may be required under this paragraph will be in accordance with
relevant Federal Acquisition Regulations and terms of the final contract.


 


Human Mesenchymal Stem Cell Manufacturing
Process Description


 


Osiris is providing a description of the manufacturing process flow to
provide a reference point for statements made about manufacturing, stability
testing, and product release testing in this SOW.


 


Figure 2.1-1 is an overview of the ex vivo
cultured hMSC manufacturing process. The flow starts with the BMA, continues
with the production of the Drug Substance (Donor cell bank, DCB, in-process
intermediate), and ends with the generation of the Medicinal Product (Product
dose, PD) shipped for use in clinical trials. The DCB is an in-process
intermediate and a major in-process control for the overall manufacturing 


 










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Figure 2.1-1. Overall
Schematic of the Ex Vivo Cultured hMSC Manufacturing Process


 


process for making the PD. One single BMA can
generate numerous PD lots. Please note that this is a representative diagram
that does not reflect the actual number of DCBs and PDs generated during the
manufacturing process.


 


1.              Donor Cell Bank, DCB - The DCB is a
process intermediate of cryopreserved, partially expanded hMSCs, representing
the first two cell passages (P0→P1, P1→P2). The DCB is used as the
starting material for Product Dose.


 


2.              Product Dose, PD — The PD is
the final packaged product, representing the three cell passages (P2→P3,
P3→P4, P4→P5). The PD is ultimately released for distribution and
use in clinical trials.


 


C.3.         Contract Objectives


 


C.3.1.     Investigational New Drug (IND)


 


Osiris shall
provide all labor and materials to prepare and submit an IND for ARS. Osiris
shall submit copies of regulatory documents to the government in accordance
with CDRL A006.


 


Osiris
has completed several INDs demonstrating a strong safety profile. These INDs
will be used to support the IND for ARS. The IND designation and current
clinical status for each investigational agent that supports the IND for ARS is
given in Figure 2.1-2.


 


ProchymalTM
is the product that is intended for use in treating ARS. The ProchymalTM
formulation is identical to that of the development-stage Osiris product
ProvacelTM. Both are intended for IV delivery. The current cryopreserved
ChondrogenTM formulation is also identical to ProchymalTM. However, further
processing steps are required prior to ChondrogenTM use, and the agent is
injected directly into the knee joint.


 










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  Product Name

  	
  IND Number

  	
  Disease Category

  	
  Indication

  	
  Clinical Status

  
	
  ProchymalTM

  	
  BB-IND-7939

  	
  Immune

  	
  grade II-IV acute 
  GvHD

  	
  Phase
  II completed

  
	
  ProchymalTM

  	
  BB-IND-7939

  	
  Immune

  	
  treatment
  refractory acute  GvHD

  	
  Phase
  II completed

  
	
  ProchymalTM

  	
  BB-IND-7939

  	
  Immune

  	
  steroid
  refractory acute  GvHD

  	
  Phase
  III initiated

  
	
  ProchymalTM

  	
  BB-IND-12770

  	
  Immune

  	
  Crohn’s
  Disease

  	
  Phase
  II completed

  
	
  ProvacelTM

  	
  BB-IND-10419

  	
  Cardiovascular

  	
  myocardial
  infarction

  	
  Phase
  I completed

  
	
  ChondrogenTM

  	
  BB-IND-10441

  	
  Orthopedics

  	
  meniscal
  repair (knee)

  	
  Phase
  I/II completed

  
	
   

  	
   

  	
   

  	
   

  	
  OMR-025

  



 


Figure 2.1-2. ProchymalTM’s
advanced regulatory approval status reduce the risk fo approval for its us in
ARS


 


Osiris is far
along in the clinical development of ProchymalTM with the completion of three Phase II human
trials. Pivotal ARS animal trials following the animal rule are all that
remain before product approval, as shown in Figure 2.1-3.


 


C.3.1.1.                              Conduct Small Scale Manufacturing for
cGMP MRC


 


Osiris
has completed small-scale process development and qualification for ProchymalTM
and currently manufactures ProchymalTM for clinical trials in three cGMP
compliant manufacturing facilities. This is the same product that would be used
for treating radiation exposure.


 


The
manufacturing process for ex vivo cultured hMSCs has been designed and
implemented in a manner consistent with International Conference on
Harmonization (ICH) and Food and Drug Administration (FDA)’s regulatory
guidelines. Specific considerations are given to cGMP regulations (21 CFR Part 210
and 211) and practicing aseptic techniques as defined in Guidance for Industry:
Sterile Drug Products Produced by Aseptic Processing - cGMPs. For the
manipulation of human-derived tissue material, consideration is given to FDA
policies on human-derived products: 21 CFR 1271 Human Cells, Tissues, and
Cellular and Tissue Based Products and Guidance for the Submission of
Chemistry, Manufacturing and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products (US Federal Register Docket No. 95N-0200).


 


CHANGE


“Rats”
to “Small Animal”


 





 


 


Figure
2.1-3. Osiris has completed the clinical development objectives for this
contract through Phase II human trials. Pivotal minimal efficacy studies are
all that remain for FDA approval


 










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C.3.1.2.                              Manufacture cGMP for Nonclinical
Toxicology and Phase I


 


Osiris
has completed the Phase I clinical trial that shall be used to support the ARS
IND (see section C.3.1.8) Osiris has completed non-clinical toxicology studies
that shall be used to support the ARS IND (see section C.3.1.5).


 


C.3.1.3.                              Develop
Product Formulations Suitable for Administration in Humans


 


Osiris
has completed development of a product formulation that is suitable for
administration in humans and a delivery system that is suitable for military
use. The final product formulation contains 100 x 10(6) viable hMSCs plus
the following excipients: HSA, DMSO and PlasmaLyte-A®. These
excipients are required to maintain stable, viable cells through the freezing
and thawing process. DMSO is a cryopreservative to assist in freezing. HSA is
protein that acts a cellular stabilizer and provides protection from shearing
forces in agitated cell culture systems. PlasmaLyte-A® is an
electrolyte solution that acts as the diluent. All of the excipients are
compatible with the hMSCs. There are no novel excipients in the formulation.


 


At
the final stage of production, the product is filled into bags and cryopreserved
at the manufacturing facility. The product is then shipped to the clinical site
where it is stored, thawed, diluted and administered intravenously.


 


Osiris shall
continue product development efforts towards achieving ease of administration
in an operational military environment (see section C.3.2.3).


 


C.3.1.4.                              Develop and Validate Analytical Assays
For Small-Scale Lot Release


 


Osiris
has completed development and validation of analytical assays for cGMP
compliant product characterization and lot release. The lot release
specifications were established in cooperation with FDA. The lot release specs
are currently being used to release product for a Phase III clinical trial to
treat  GvHD. Lot release is performed on
the in-process intermediate (Donor Cell Bank, DCB) and on the final product
(Product Dose, PD). The lot release specs for DCB include tests for cell
phenotype, potency, appearance, viruses, cell line species identity,
karotyping, sterility, endotoxin and mycoplasma. The lot release specs for PD
include tests for viability, cell phenotype, potency, appearance, sterility,
endotoxin, and mycoplasma.


 


INSERTED TEXT


 


Osiris believes that the current potency assay used for product release
of ProchymalTM for the treatment of GvHD is also relevant for use as a release
assay for ProchymalTM for the treatment of ARS. Osiris will discuss the the
utility of the TNFR release assay for product release for the ARS indication
with FDA. In the event that FDA requires an alternate assay, Osiris will
proceed with development of an ARS-specific
release assay accordingly. For product release of animal MSCs for use in
preclinical studies, Osiris will develop a corresponding assay targeting the
analog molecular marker.


 






August 10, 2007


 


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of data contained on this sheet is subject to the restriction on the title page
of this proposal.


 


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C.3.1.5.                              Conduct Appropriate Nonclinical GLP Acute
Toxicology Studies


 


Osiris
has completed a GLP acute toxicology study to support ProchymalTM.
This study was reviewed and verbally approved by FDA and shall support the BLA
filing for ProchymalTM for ARS.


 


C.3.1.6.                              Perform Efforts to Ensure the Successful
Submission of an IND


 


Osiris shall
perform the necessary and appropriate efforts to assure the successful
submission of an IND for ARS.


 


C.3.1.7.                              Support the Submission of an EUA with of
Letters of Cross-Reference


 


Osiris shall
support the submission of an EUA by preparation of letters that cross-reference
the IND file and/or other regulatory documentation.


 






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of this proposal.


 


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C.3.1.8.                              Conduct Phase I Clinical Study in
Accordance with FDA GCP


 


Osiris
has completed a Phase I dose escalation clinical safety study in a relevant
human subject population in accordance with FDA Good Clinical Practices (GCP).
This was Osiris Protocol 401. Osiris Protocol 401 was a safety study testing hMSC
treatment for people who had suffered an acute myocardial infarction (AMI).
This Phase I study shall be used to support pivotal animal trials for ProchymalTM-ARS.
To date, Osiris has completed several clinical trials for IV administration of
hMSCs and is currently conducting a Phase III clinical trial for treating  GvHD (see Figure 2.1-2). IRB approval was
necessary at all institutions that participated in the clinical trials.


 


INSERTED TEXT


 


Osiris believes the current safety profile for ProchymalTM will support
a BLA filing for the use of ProchymalTM as an ARS therapy. However, Osiris will arrange a Type B
meeting with FDA to confirm the sufficiency of current human safety data for an
ARS BLA.


 


C.3.1.9.                              Store Phase 1 Product for Two Years
Following Clinical Trial


 


INSERTED TEXT


 


Osiris shall store Phase I product under
cGMP-controlled conditions for two years following the clinical trial. Osiris
has stored Phase I product under cGMP-controlled conditions from a Phase I
safety study completed in October 2001(Protocol 201).


 


Osiris’ most recent Phase I safety study (Protocol 401) was completed in May 2006.
Osiris shall store this product until May 2008.


 


C.3.1.10.                       Perform an ICH-Compliant Stability
Testing Program


 


Osiris shall perform an ICH-compliant stability program on ProchymalTM.
The stability program is currently being reviewed by FDA and is planned to
capture stability data for 30 months.


 


C.3.2.                                        Conduct Activities Leading to FDA
Approval of the Product


 


INSERTED TEXT


 


Osiris shall conduct activities to lead to FDA approval of ProchymalTM
for ARS. Osiris plans to file for approval under the animal rule. However, data
collected in GLP animal studies will be supplemented with human data obtained
in a Phase II clinical trial to evaluate the safety and efficacy of ProchymalTM
therapy for the treatment of radiation-induced enteropathy.


 






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C.3.2.1.                              Scale-up Manufacturing Processes


 


Osiris shall
scale-up the manufacturing process to achieve a cGMP compliant large-scale
manufacturing process. Osiris is currently
scaling-up ProchymalTM production to meet clinical trial demands. In
order to meet clinical trial demands, and in preparation for eventual product
marketing, Osiris has contracted outside manufacturing facilities to
manufacture ProchymalTM. More manufacturing facilities shall be
contracted if necessary to produce product for this contract. Osiris shall
conduct product comparability studies to demonstrate cGMP-compliant product
comparability between contract manufacturers.


 


Presently,
MSC manufacturing takes place at the following three GMP compliant
manufacturing facilities.


 


1.              Osiris Therapeutics, Inc.

2001 Aliceanna Street,

Baltimore, MD 21231


 


2.              Lonza Bioscience

8830 Biggs Ford Road

Walkersville, MD 21793


 


3.              AppTec

4751 League Island Blvd.

Philadelphia, PA 19112


 






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of this proposal.


 


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FDA
granted Osiris comparability approval for product manufactured at Osiris and at
Lonza Bioscience.


 


Osiris shall
conduct qualification and validation studies of the manufacturing process.
These studies are currently underway to support licensure of ProchymalTM-
GvHD. The same manufacturing process shall be used for ProchymalTM-ARS.


 


C.3.2.2.                              Manufacture cGMP Product Suitable for
Expanded Nonclinical Safety Studies, Definitive Animal Efficacy Studies, and
Phase II Clinical Trials


 


Osiris
has completed non-clinical safety and toxicology studies. FDA has reviewed
these studies and has deemed them acceptable for supporting a BLA filing for
ProchymalTM-GvHD.


 


Osiris shall
contract out cell production for definitive animal efficacy studies.


 


Osiris
has completed Phase II clinical trials that support the safety profile for
ProchymalTM.


 


Osiris
has completed an FDA approved comparability study on consistency lots, which
demonstrated comparability between Osiris and Lonza Bioscience cGMP manufactured
product.


 


Osiris shall cooperate with the FDA
Pre-Approval Inspection as required for product approval.


 


C.3.2.3.                              Refine and Select a Final Product
Formulation Suitable for Military Use


 


Osiris
has completed development of a product formulation that is suitable for
administration in humans and a delivery system that is suitable for military
use (see section C.3.1.3).


 


For the
military setting, we foresee a scenario where the product would be stored in
liquid nitrogen freezers at a secure location anywhere in the world. If a
radiological situation were to occur, the product could be shipped to the
treatment location. At the treatment location, the product could be thawed,
diluted with an electrolyte solution using a syringe, and administered
intravenously. There is no need for working in a sterile environment and there
is no necessity for hospital beds. The bags of cells would just have to be
thawed, spiked, diluted, and hung for intravenous delivery.


 


INSERTED TEXT


 


Osiris shall
continue development efforts for improving product storage and delivery
techniques. These activities will include studies to support alternate
packaging and storage conditions appropriate for the military setting.


 


Study Cell Delivery Technique


 


Osiris shall
test new techniques for transferring the product from the thawed product bag
into the IV bag with minimal manipulation.


 


C.3.2.4.                              Develop and Validate Analytical Assays
for Large-Scale Lot Release


 


Osiris
has completed development and validation of analytical assays for cGMP
compliant product characterization and lot release. The lot release
specifications were established in cooperation with FDA. The lot release specs
are currently being used to release product for a Phase III clinical trial to
treat  GvHD (see section C.3.1.4).


 


Lot release specifications shall be updated if required by FDA for the
scale-up manufacturing process. 


 


 






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C.3.2.5.                              Perform an ICH-Compliant Stability
Testing Program on Bulk API


 


Osiris shall
perform an ICH-compliant stability testing program on bulk API. The active
pharmaceutical ingredient (API) for ProchymalTM manufacturing is
termed the Donor Cell Bank (DCB). An ICH-compliant stability protocol for DCB
is currently under review with FDA.


 


Preliminary
data from a development study suggest that DCB is stable for a minimum of 35
months under the storage conditions of < -135°C.


 


C.3.2.6.                              Perform an ICH-Compliant Testing Program
on Formulated Product


 


Osiris shall
perform an ICH-compliant stability testing program on the cGMP formulated
product from consistency lots produced from initial large-scale manufacturing
to establish a shelf life for the product. The formulated medicinal product is
termed Product Dose (PD). An ICH-compliant stability protocol for PD
consistency lots is currently under review with FDA


 


Preliminary
data from a development study suggest that the PD is stable for at least 18
months under the storage conditions of < -135°C.


 


C.3.2.7.                               Stability
Testing to Establish Operational Storage and Distribution Temperature Ranges
and Extremes


 


Osiris shall
conduct stability testing to establish operational storage and distribution
ranges as well as temperature extremes. One major benefit of ProchymalTM
is that it can be administered several days after radiation exposure, and
therefore does not need to be carried on the warfighter. The product can be
shipped anywhere in the world within this dosing window. The product cannot be
carried on the warfighter because it needs to be stored at ultra-low
temperatures. Osiris suggests storing the product in remote liquid nitrogen
freezers until a radiological incident occurs. When a radiation exposure
occurs, the product would just need to be removed from remote liquid nitrogen
freezers and shipped to arrive on site as soon as possible. Osiris requests
assistance from the military in determining the optimal logistical plan for
shipping the product following a radiological incident.


 


With the
current envisioned logistical scenario in mind, Osiris shall perform studies to
establish operational storage and distribution temperature ranges, as well as
temperature extremes expected for use in the field.


 


Study 1. Shipping Stability


 


Osiris shall
test product stability in shipping containers at temperature extremes.


 


Study 2. Product Stability After Thaw


 


Osiris shall
test post thaw product stability at temperature extremes that are possible in a
military setting.


 


C.3.2.8.                              Conduct Appropriate Nonclinical Studies
in Accordance with GLP Regulations and Guidelines to Support Submission of a
BLA/NDA


 


Osiris
has completed appropriate nonclinical studies in accordance with GLP
regulations and guidelines to support submission of a BLA for ProchymalTM- GvHD. This nonclinical package shall be used for ProchymalTM-ARS.










August 10, 2007                                                                                                                                                                                   


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of this proposal.


 


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On
February 21st 2007, FDA agreed that the package of preclinical
studies submitted and underway was appropriate to support BLA for ProchymalTM-GvHD. The package of studies included acute infusional
toxicity, cardiovascular safety, pulmonary safety, immunological study, ectopic
foci formation, and biodistribution.


 


A
technical hurdle exists for PK and absorption, distribution, metabolism, and
excretion (ADME) studies for cell therapies. There is currently no good cell
tracking technique. This topic has been addressed with FDA. Osiris’ clinical
and non-clinical studies shall support the submission of a BLA.


 


C.3.2.9.                              Conduct Necessary Definitive Efficacy
Studies in Relevant Animal Models in Accordance with GLP Regulations and
Guidelines


 


Osiris shall
perform efficacy studies in relevant animal models in accordance with GLP
regulations and guidelines. Osiris shall discuss these studies with FDA for
product approval under the animal rule.


 


REPLACED TEXT


“Rats”
to “small animal”, studies include tissue repair.


 


Osiris shall
perform the following studies:


 


1.              Small animal studies using total body
irradiation to evaluate survival and tissue repair in ProchymalTM-treated and
control subjects. GI data shall be analyzed.


 


2.              Non-human primate survival study using
total body irradiation. GI data shall be analyzed.


 


3.              Non-human primate GI-efficacy study using
targeted abdominal irradiation. This study shall only be conducted if targeted
abdominal irradiation is needed for FDA approval.


 


C.3.2.10.                       Conduct a Phase II Expanded Safety
Clinical Study in a Relevant Human Subject Population in Accordance with GCP


 


Osiris
has completed two Phase II studies in relevant human subject populations in
accordance with cGCP. The human subjects in these trials were people with GI
damage resulting from  GvHD. The damage
to the intestinal mucosa from  GvHD and
irradiation is the same. IRB approval was obtained at all clinical sites
involved in these clinical trials.


 


INSERTED TEXT


 


To further supplement data
collected under the Animal Rule, Osiris will conduct a Phase II clinical study
to explore the safety and efficacy of ProchymalTM therapy for treating normal
tissue damage in the GI tract in patients that have received radiotherapy.  This development strategy will mitigate risks
associated with product approval under the Animal Rule. FDA representatives
have recently commented publicly that, for products evaluated under the Animal
Rule, supplementation of animal data with human data collected in clinical
trials would be considered “highly valued”.


 


C.3.2.11.                       Submit a NDA/BLA for FDA Review


 


Osiris shall
prepare and submit a BLA for FDA review for treating ARS. Osiris has completed
a Pre-IND meeting with FDA on February 26th to discuss an ARS
IND.


 


Osiris shall
prepare and submit responses to requests for additional information from FDA
during the review process.










August 10, 2007                                                                                                                                                                                   


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of data contained on this sheet is subject to the restriction on the title page
of this proposal.


 


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C.3.2.12.                       Deliver One Dose of the FDA-Approved MRC
to the Government


 


Osiris shall
deliver a minimum of one dose of the FDA approved countermeasure as part of
CLIN 00001.


 


C.3.3.                                        Prepare a SOW, IMS, CWBS, CWBS Dictionary,
and Integrated Risk Management Plan


 


Osiris shall
submit a SOW, IMS (CDRL A004), CWBS (CDRL A003), CWBS dictionary and Integrated
Risk Management Plan for the proposal that encompasses the entire scope of the
project. The IMS and CWBS shall be updated monthly. The CWBS elements shall
define the complete scope of the contract to a breadth and depth necessary to
describe the proposed effort to a minimum of Level 4.










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of this proposal.


 


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C.3.4.                                        Prepare a Technical Data Package (TDP)


 


Osiris shall
prepare a TDP (CDRL A007) solely for the use of ProchymalTM to treat Acute Radiation Syndrome. This
TDP shall include technical information pertaining to the manufacture, safety,
and known efficacy of ProchymalTM for the sole purpose of treating
complications from Acute Radiation Syndrome.


 


C.3.5.                                        Option: Prepare and Deliver a DMF


 


Osiris
has completed a Master File with FDA for the ex vivo manufacture of human
mesenchymal stem cells (MF-13146).


 


C.3.6.                                        Option: Produce 50,000 — 500,000 Troop
Equivalent Doses (TED) of the MRC


 


If the option
is exercised by the government, Osiris shall produce no fewer that 50,000 and
not to exceed 500,000 Troop Equivalent Doses (TED) of the MRC and shall deliver
product to the government as directed.


 


C.4.                                                  General


 


C.4.1.                                        Provide the Necessary Qualified
Personnel, Facilities, Equipment, Supplies, Services, Subcontractors and
Related Administrative and Information Technology Support


 


Osiris shall
provide the necessary qualified personnel, facilities, equipment, supplies, services,
subcontractors, and related administrative information technology support to
accomplish the objectives.


 


C.4.2.                                        Allow Access to Records Files and Other
Data for FDA and/or MITS JPMO Audit


 


Osiris shall
allow access to records, files, and other data derived from this work for the
purposes of audit by the FDA and/or by MITS JPMO or its designees.


 


C.4.3.                                        Allow the Government or its Designee to
Audit the Contractor and/or its Subcontractor for Regulatory Compliance and
Quality Assurance Purposes


 


Osiris shall
allow the Government or its designee to audit Osiris and/or its subcontractors
for regulatory compliance and quality assurance purposes.


 


C.4.4.                                        Provide Monthly Contractor’s Progress,
Status and Management Reports


 


Osiris shall
provide monthly Progress, Status, and Management Reports (CDRL A001) that
describe progress made within the period, summarize projected vs. actual
progress, report costs, and inform the government of existing or potential
problem areas. Invoices shall be submitted during the report month. Osiris
shall submit a monthly Contract Performance Report (CPR) in accordance with
CDRL A005.


 


C.4.5.                                        Provide Quarterly Contract Funds Status
Reports Using DD Form 1568


 


Osiris shall
provide quarterly Contract Funds Status Reports using DD form 1568. Osiris
shall participate in a periodic teleconference in accordance with CDRL A002.
Osiris shall submit a MS PowerPoint presentation for quarterly Interim Program
Reviews in accordance with CDRL A008.






August 10, 2007                                                                                                                                                                                   


Use or disclosure
of data contained on this sheet is subject to the restriction on the title page
of this proposal.


 


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  Attachment 1

  W9113M-08-C-0028

  Page 15 of 15

  



 


 


Solicitation Number: W9113M-07-R-0002










 


C.4.6.                                        Utilize an Earned Value Management (EVM)
System Complying With The Criteria Provided in the American National Standards
Institute/Electronic Industries Alliance (ANSI/EIA) Standard 748


 


Osiris shall
use an Earned Value Management System (EVMS) recognized by the Administrative
Contracting Officer (ACO) as complying with the criteria provided in American
National Standards Institute (ANSI)/Electronic Industries Alliance (EIA) EVMS
standard (ANSI/EIA-748), DoD 5000.2-R, Mandatory Procedures for Major Defense
Acquisition Program (MDAPs) and Major Automated Information System (MAIS)
Acquisition programs (DFARS 252.242-7001 and DFARS 252.242-7002) as well as the
policy letter, “Revision to DoD Earned Value Management Policy” dated March 7,
2005.


 


Osiris shall
hold an Integrated Baseline Review (IBR) to assess the realism and accuracy of
the integrated performance measurement baseline. The IBR shall be initiated no
later than 6 months from the contract award, the exercise of significant
contract options, and the incorporation of major modifications or as otherwise
agreed upon. Osiris shall provide monthly EVM reports.


 


C.4.7.                                        Provide a Summary Report of Events That
Will Cause More Than a Two Week Delay in Schedule or an Increase in Cost
Estimate At Completion


 


Osiris shall
provide a Summary Report within three working days of events that will cause
more than a two-week delay in schedule, or an increase in cost Estimate at
Completion.


 


C.4.8.                                        Participate in Teleconference as Needed


 


Osiris shall
participate in teleconference with the government when needed. Osiris shall
provide minutes of the teleconferences within one week.


 


C.4.9.                                        Employ an Automate Information System
(AIS)


 


Osiris shall
employ an automated information system (AIS) in accordance with electronic
common technical document (eCTD) and ICH guidance for electronic data
submissions to FDA.


 


Osiris
currently submits all documents to FDA electronically through the secure
electronic submission gateway.


 


Osiris shall
allow MITS JPMO read only remote access via Osiris’ AIS to clinical and
non-clinical data pertaining to ARS following quality assurance review and
acceptance.


 


C.4.10.                                 Report All Contractor Manpower (Including
Subcontractor Manpower) Required for Performance of this Contract


 


Osiris shall
report all contract manpower (including subcontractor manpower) required for
performance of this contract. Osiris shall completely fill in information using
the Army data collection site at (URL: https://contractormanpower.army.pentagon.mil).


 


Osiris shall
provide estimated total cost (if any) incurred to comply within this reporting
requirement. The reporting period will be the period of performance not to
exceed twelve months ending September 30 of the Government’s Fiscal Year
and must be reported by October 31 of each subsequent Fiscal Year.






August 10, 2007                                                                                                                                                                                   


Use or disclosure
of data contained on this sheet is subject to the restriction on the title page
of this proposal.


 


2.1-10