Exhibit 10.33
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AWARD/CONTRACT 1. This contract is rated order Rating Page of Pages
under DPAS (15 CFR 350) DO C9 1 of 34
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2. Contract No. 3. Effective Date 4. Requisition/Purchase Request/
Project No.
SP0200-99D-0007 7-30-99 DD#80004______________________
5. Issued by Code SP0200 6. Administered by (if other than Item 5) Code S2101A
DEFENSE SUPPLY CENTER PHILADELPHIA DCMC BALTIMORE
ATTN: DSCP-MGAA (BLDG #6) 000 XXXX XXXXXXX XXXXXX
000 XXXXXXX XXXXXX XXXXX 0000
XXXXX., XX 00000-0000 XXXXXXXXX, XX 00000-5299
ATTN: X. XXXXXX (DSCP-MGAA-PGC)
000-000-0000
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7. Name and Address if Contractor 8. Delivery
(No.,Street,city,county,state,zipcode)
MERIDIAN MEDICAL TECHNOLOGIES, INC.
00000 XXX XXXXXXXX XXXX / / FOB ORIGIN / / OTHER
COLUMBIA, MD 21046
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ATTN: XX. XXXXXXXX X'XXXXXX 9. Discount for Prompt Payment
-------------------------------------------- .5% 10 DAYS
CODE 54452 FACILITY CODE ------------------------------------
10. SUBMIT INVOICES ITEM
11. SHIP TO/MARK FOR CODE _______________ (4 copies unless otherwise
ADDRESS SHOWN IN:
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CODE HQ0338
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12. PAYMENT WILL BE MADE BY
DFAS-COLUMBUS CENTER
DFAS-CO/SOUTH ENTITLEMENT OPERATIONS
P.O. BOX 182264
SEE INDIVIDUAL DELIVERY ORDER COLUMBUS, OH 43218-2264
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13. AUTHORITY FOR USING OTHER THAN FULL 14. ACCOUNTING AND APPROPRIATION
AND OPEN COMPETITION: DATA
/ / 10USC2304(C) ( 3 ) / / 41USC253(C)( ) MG97X4930 5CMO 01 26.0 S33150
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15.A. 15B. 15C. 15D. 15E. 15F.
ITEM No. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
SEE ATTACHED PAGES
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15G. TOTAL AMOUNT OF CONTRACT $
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16. TABLE OF CONTENTS
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(X) SEC DESCRIPTION PAGE(S)
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PART I - THE SCHEDULE
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A SOLICIATION/CONTRACT FORM
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X B SUPPLIES OR SERVICES AND PRICES/COST
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X C DESCRIPTION/SPECS/WORK STATEMENT
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D PACKAGING AND MARKING
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E INSPECTION AND ACCEPTANCE
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F DELIVERIES OR PERFORMANCE
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G CONTRACT ADMINISTRATION DATA
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H SPECIAL CONTRACT REQUIREMENTS
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PART II - CONTRACT CLAUSES
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X I CONTRACT CLAUSES
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PART III - LIST OF DOC. EXHIBITS & OTHER ATTACH.
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J LIST OF ATTACHMENTS
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PART IV - REPRESENTATIONS AND INSTRUCTIONS
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K REPRESENTATION,CERTIFICATION AND OTHER STATEMENTS OF OFFERORS
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L INSTRS.,CONDS., & NOTICES TO OFFERORS
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M EVALUATION FACTORS FOR AWARD
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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17. / / CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return _______copies to issuing office.) Contractor agrees to
furnish and deliver all items or perform all the services set forth or otherwise
identified above and on any continuation sheets for the consideration stated
herein. 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. / / AWARD (Contractor is not required to sign this document) Your offer on
Soliciation Number SP0200-98R-1002 (see page 13), 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 consummate the contract 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.
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19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
XXXXXX X. X'XXXXX - VP-FINANCE/CFO XXXX XXXXXX
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19B. NAME OF CONTRACTOR 19C. DATED SIGNED
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20B. UNITED STATES OF AMERICA 20C. DATED SIGNED
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BY BY
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(Signature of person auth. to sign) (Signature of Contracting Officer
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nsn 7540-01-152-8069 26-107 STANDARD FORM 28 (REV.4-85) (EG)/
PRESCRIBED BY GSA
PREVIOUS EDITION UNUSABLE PERFORM (DLA) FAR (48 CFR) 43.214 (a)
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CONTINUATION SHEET: SP0200-99D-0007 Page 2 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SECTION B
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0001 BASE MAINTENANCE/SERVICE
To provide labor, services and incremental production as directed by
the Government in accordance with statement of work.
0002 LOGISTICS MAINTENANCE
To provide segregation of goods, disassembly into components, shelf
life extension program, and storage in accordance with statement of work.
0003 DIVISION-READY BRIGADE SET PROGRAM
To provide on-site support for the storage, assembly, and shipment of
Division-Ready Brigade Sets in accordance with statement of work.
0004 BASE MAINTENANCE/MATERIAL
To provide completely assembled Mark I Kits, Atropine, Pralidoxime,
Diazepam, and Morphine Auto Injectors using refurbished and/or new components in
accordance with statement of work.
0005 MOBILIZATION SURGE OPTION
To provide material in the event of a mobilization surge contingency or
other Government need. The contractor will ship to those locations identified by
the Contracting Officer up the maximum quantities indicated.
0006 VENDOR VALIDATION
Validation testing and direct plant support costs for new Pralidoxime
supplier.
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CONTINUATION SHEET: SP0200-99D-0007 Page 3 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0001 BASE MAINTENANCE/SERVICE
0001AA BASE YEAR 1 LT $7,657,018 $7,657,018
0001AB OPTION YEAR ONE 1 LT $8,005,263 $8,005,263
0001AC OPTION YEAR TWO 1 LT $8,309,044 $8,309,044
0002 LOGISTICS MAINTENANCE
0002AA BASE YEAR 1 LT $2,052,506 $2,052,506
0002AB BASE YEAR ONE 1 LT $2,128,455 $2,128,455
0002AC BASE YEAR TWO 1 LT $2,206,383 $2,206,383
0003 DIVISION-READY BRIGADE SET PROGRAM
0003AA BASE YEAR 1 LT $0 $0
0003AB OPTION YEAR ONE 1 LT $0 $0
0003AC OPTION YEAR TWO 1 LT $0 $0
0004 BASE MAINTENANCE/MATERIAL ANNUAL ESTIMATE
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0004AA BASE YEAR
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XXXX X (6505-01-174-9919) 462,000 EA $8.44 $3,899,280
1 thru 499,999 $8.44
500,000 thru 749,999 $8.05
750,000 thru 999,999 $7.84
1,000,000 thru 1,200,000* $7.72
ATROPINE (6505-00-926-9083) 400,000 EA $2.69 $1,076,000
1 thru 499,999 $2.69
500,000 thru 749,999 $2.60
750,000 thru 999,999 $2.52
1,000,000 thru 1,200,000* $2.49
PRALIDOXIME (6505-01-125-3248) 250,000 EA $5.39 $1,347,500
1 thru 499,999 $5.39
500,000 thru 749,999 $5.09
750,000 thru 999,999 $4.96
1,000,000 thru 1,200,000* $4.88
DIAZEPAM (6505-01-274-0951) 400,000 EA $4.71 $1,884,000
1 thru 499,999 $4.71
500,000 thru 749,999 $4.43
750,000 thru 999,999 $4.30
1,000,000 thru 1,200,000* $4.21
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CONTINUATION SHEET: SP0200-99D-0007 Page 4 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
MORPHINE (6505-01-302-5530) 300,000 EA $2.94 $882,000
1 thru 499,999 $2.94
500,000 thru 749,999 $2.84
750,000 thru 999,999 $2.76
1,000,000 thru 1,200,000* $2.72
0004AB OPTION YEAR ONE
---------------
MARK I (6505-01-174-9919) 462,000 EA $8.71 $4,024,020
1 thru 499,999 $8.71
500,000 thru 749,999 $8.30
750,000 thru 999,999 $8.09
1,000,000 thru 1,200,000* $7.97
ATROPINE (6505-00-926-9083) 400,000 EA $2.78 $1,112,000
1 thru 499,999 $2.78
500,000 thru 749,999 $2.69
750,000 thru 999,999 $2.61
1,000,000 thru 1,200,000* $2.57
PRALIDOXIME (6505-01-125-3248) 250,000 EA $5.55 $1,387,500
1 thru 499,999 $5.55
500,000 thru 749,999 $5.24
750,000 thru 999,999 $5.11
1,000,000 thru 1,200,000* $5.03
DIAZEPAM (6505-01-274-0951) 400,000 EA $4.87 $1,948,000
1 thru 499,999 $4.87
500,000 thru 749,999 $4.58
750,000 thru 999,999 $4.45
1,000,000 thru 1,200,000* $4.36
MORPHINE (6505-01-302-5530) 300,000 EA $3.04 $912,000
1 thru 499,999 $3.04
500,000 thru 749,999 $2.93
750,000 thru 999,999 $2.85
1,000,000 thru 1,200,000* $2.81
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CONTINUATION SHEET: SP0200-99D-0007 Page 5 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0004AC OPTION YEAR TWO
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MARK I (6505-01-174-9919) 462,000 EA $8.98 $4,148,760
1 thru 499,999 $8.98
500,000 thru 749,999 $8.56
750,000 thru 999,999 $8.35
1,000,000 thru 1,200,000* $8.22
ATROPINE (6505-00-926-9083) 400,000 EA $2.88 $1,152,000
1 thru 499,999 $2.88
500,000 thru 749,999 $2.78
750,000 thru 999,999 $2.70
1,000,000 thru 1,200,000* $2.66
PRALIDOXIME (6505-01-125-3248) 250,000 EA $5.71 $1,427,500
1 thru 499,999 $5.71
500,000 thru 749,999 $5.39
750,000 thru 999,999 $5.26
1,000,000 thru 1,200,000* $5.17
DIAZEPAM (6505-01-274-0951) 400,000 EA $5.05 $2,020,000
1 thru 499,999 $5.05
500,000 thru 749,999 $4.74
750,000 thru 999,999 $4.60
1,000,000 thru 1,200,000* $4.51
MORPHINE (6505-01-302-5530) 300,000 EA $3.15 $945,000
1 thru 499,999 $3.15
500,000 thru 749,999 $3.04
750,000 thru 999,999 $2.95
1,000,000 thru 1,200,000* $2.91
*Pricing limited to quantities, excluding Pre-stock units, of 1.2 million each
of Mark I Injectors or 1.2 million injectors Atropine and/or Morphine Injectors
and 1.2 million Pralidoxime and/or Diazepam Injectors.
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CONTINUATION SHEET: SP0200-99D-0007 Page 6 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ADDITIONAL AVAILABLE QUANTITIES UNDER LINE ITEM 0004
During any contract year, if the Government has reached the 2.4 million unit
autoinjector limit under item 0004 (1.2 million each of Mark 1 injectors or 1.2
million Atropine and/or Morphine injectors and 1.2 million Pralidoxime and/or
Diazepam injectors), the Government is entitled to purchase up to an additional
499,999 units during that year, without exercising Line Item 0005, Mobilization
Surge Option. The pricing is as follows, for these non mobilization surge
quantities exceeding the 2.4 million annual threshold:
Base Period Option Year One Option Year Two
----------- ----------- -------------------
MARK 1 $10.85 $11.13 $11.47
ATROPINE $3.51 $3.61 $3.73
PRALIDOXIME $6.88 $7.04 $7.25
DIAZEPAM $6.38 $6.55 $6.76
MORPHINE $3.85 $3.96 $4.08
These extra quantities above the 2.4 million will be delivered 150 days after
date of delivery order, but Contractor will not be required to deliver these
additional quantities during the months of June, July, and August. If delivery
of the 499,999 falls after the end of the contract year in which the delivery
order was issued, the price will not be increased to the next years pricing, nor
will the quantities be subtracted from the next years 2.4 million available
quantity.
This in no way limits the Government's rights to purchase quantities against
Line Item 0004, or to exercise Line Item 0005, or any other rights under this
contract
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CONTINUATION SHEET: SP0200-99D-0007 Page 7 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
PRESTOCK COMPONENT PRICING
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0004AD BASE YEAR
---------
MARK I (6505-01-174-9919)
1 thru 499,999 EA $6.44
500,000 thru 749,999 EA $6.17
750,000 thru 999,999 EA $6.00
1,000,000 thru 1,200,000 EA $5.91
ATROPINE (6505-00-926-9083)
1 thru 499,999 EA $2.01
500,000 thru 749,999 EA $1.95
750,000 thru 999,999 EA $1.89
1,000,000 thru 1,200,000 EA $1.86
PRALIDOXIME (6505-01-125-3248)
1 thru 499,999 EA $4.13
500,000 thru 749,999 EA $3.92
750,000 thru 999,999 EA $3.82
1,000,000 thru 1,200,000 EA $3.76
DIAZEPAM (6505-01-274-0951)
1 thru 499,999 EA $3.53
500,000 thru 749,999 EA $3.33
750,000 thru 999,999 EA $3.22
1,000,000 thru 1,200,000 EA $3.16
MORPHINE (6505-01-302-5530)
1 thru 499,999 EA $2.18
500,000 thru 749,999 EA $2.11
750,000 thru 999,999 EA $2.05
1,000,000 thru 1,200,000 EA $2.02
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CONTINUATION SHEET: SP0200-99D-0007 Page 8 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
PRESTOCK COMPONENT PRICING
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0004AE OPTION YEAR ONE
---------------
MARK I (6505-01-174-9919)
1 thru 499,999 EA $6.64
500,000 thru 749,999 EA $6.36
750,000 thru 999,999 EA $6.19
1,000,000 thru 1,200,000 EA $6.09
ATROPINE (6505-00-926-9083)
1 thru 499,999 EA $2.08
500,000 thru 749,999 EA $2.02
750,000 thru 999,999 EA $1.96
1,000,000 thru 1,200,000 EA $1.93
PRALIDOXIME (6505-01-125-3248)
1 thru 499,999 EA $4.25
500,000 thru 749,999 EA $4.03
750,000 thru 999,999 EA $3.93
1,000,000 thru 1,200,000 EA $3.86
DIAZEPAM (6505-01-274-0951)
1 thru 499,999 EA $3.65
500,000 thru 749,999 EA $3.45
750,000 thru 999,999 EA $3.34
1,000,000 thru 1,200,000 EA $3.27
MORPHINE (6505-01-302-5530)
1 thru 499,999 EA $2.26
500,000 thru 749,999 EA $2.19
750,000 thru 999,999 EA $2.12
1,000,000 thru 1,200,000 EA $2.09
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CONTINUATION SHEET: SP0200-99D-0007 Page 9 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
PRESTOCK COMPONENT PRICING
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0004AF OPTION YEAR TWO
---------------
MARK I (6505-01-174-9919)
1 thru 499,999 EA $6.85
500,000 thru 749,999 EA $6.56
750,000 thru 999,999 EA $6.39
1,000,000 thru 1,200,000 EA $6.28
ATROPINE (6505-00-926-9083)
1 thru 499,999 EA $2.16
500,000 thru 749,999 EA $2.09
750,000 thru 999,999 EA $2.03
1,000,000 thru 1,200,000 EA $2.00
PRALIDOXIME (6505-01-125-3248)
1 thru 499,999 EA $4.38
500,000 thru 749,999 EA $4.15
750,000 thru 999,999 EA $4.05
1,000,000 thru 1,200,000 EA $3.98
DIAZEPAM (6505-01-274-0951)
1 thru 499,999 EA $3.78
500,000 thru 749,999 EA $3.57
750,000 thru 999,999 EA $3.45
1,000,000 thru 1,200,000 EA $3.38
MORPHINE (6505-01-302-5530)
1 thru 499,999 EA $2.34
500,000 thru 749,999 EA $2.26
750,000 thru 999,999 EA $2.19
1,000,000 thru 1,200,000 EA $2.16
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CONTINUATION SHEET: SP0200-99D-0007 Page 10 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0005 MOBILIZATION SURGE OPTION
0005AA BASE YEAR (FULL QTY)
MARK I (6505-01-174-9919) 2,244,762 EA $11.59 $26,016,792
ATROPINE (6505-00-926-9083) 1,079,426 EA $3.74 $4,037,053
PRALIDOXIME (6505-01-125-3248) 583,507 EA $7.51 $4,382,138
DIAZEPAM (6505-01-274-0951) 689,788 EA $7.05 $4,863,005
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.23 $6,417,862
0005AB OPTION YEAR ONE (FULL QTY)
MARK I (6505-01-174-9919) 2,244,762 EA $11.88 $26,667,773
ATROPINE (6505-00-926-9083) 1,079,426 EA $3.87 $4,177,379
PRALIDOXIME (6505-01-125-3248) 583,507 EA $7.68 $4,481,334
DIAZEPAM (6505-01-274-0951) 689,788 EA $7.27 $5,014,759
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.37 $6,630,273
0005AC OPTION YEAR TWO (FULL QTY)
MARK I (6505-01-174-9919) 2,244,762 EA $12.28 $27,565,677
ATROPINE (6505-00-926-9083) 1,079,426 EA $4.00 $4,317,704
PRALIDOXIME (6505-01-125-3248) 583,507 EA $7.94 $4,633,046
DIAZEPAM (6505-01-274-0951) 689,788 EA $7.52 $5,187,206
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.52 $6,857,857
0005AA BASE YEAR TIER PRICING VOLUMES
(UP TO 3,000,000 UNITS)
MARK I (6505-01-174-9919) 1,101,326 EA $11.79 $12,984,634
ATROPINE (6505-00-926-9083) 529,589 EA $3.81 $2,017,734
PRALIDOXIME (6505-01-125-3248) 286,280 EA $7.64 $2,187,179
DIAZEPAM (6505-01-274-0951) 338,424 EA $7.17 $2,426,500
MORPHINE (6505-01-302-5530) 744,381 EA $4.31 $3,208,282
0005AB OPTION YEAR ONE TIER PRICING VOLUMES
(UP TO 3,000,000 UNITS)
MARK I (6505-01-174-9919) 1,101,326 EA $12.04 $13,259,965
ATROPINE (6505-00-926-9083) 529,589 EA $3.93 $2,081,285
PRALIDOXIME (6505-01-125-3248) 286,280 EA $7.81 $2,235,847
DIAZEPAM (6505-01-274-0951) 338,424 EA $7.40 $2,504,338
MORPHINE (6505-01-302-5530) 744,381 EA $4.45 $3,312,495
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CONTINUATION SHEET: SP0200-99D-0007 Page 11 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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SCHEDULE
ITEM NO. SUPPLIES QTY U/I U/P TOTAL
-------- -------- --- --- --- -----
0005AC OPTION YEAR TWO TIER PRICING VOLUMES
(UP TO 3,000,000 UNITS)
MARK I (6505-01-174-9919) 1,101,326 EA $12.50 $13,766,575
ATROPINE (6505-00-926-9083) 529,589 EA $4.07 $2,155,427
PRALIDOXIME (6505-01-125-3248) 286,280 EA $8.07 $2,310,280
DIAZEPAM (6505-01-274-0951) 338,424 EA $7.65 $2,588,944
MORPHINE (6505-01-302-5530) 744,381 EA $4.60 $3,424,153
0005AA BASE YEAR TIER PRICING VOLUMES
(3,000,001 TO 6,114,708)
MARK I (6505-01-174-9919) 2,244,762 EA $11.39 $25,567,839
ATROPINE (6505-00-926-9083) 1,079,426 EA $7.26 $7,836,633
PRALIDOXIME (6505-01-125-3248) 583,507 EA $3.60 $2,100,625
DIAZEPAM (6505-01-274-0951) 689,788 EA $6.80 $4,690,558
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.11 $6,235,795
0005AB OPTION YEAR ONE TIER PRICING VOLUMES
(3,000,001 TO 6,114,708)
MARK I (6505-01-174-9919) 2,244,762 EA $11.69 $26,241,268
ATROPINE (6505-00-926-9083) 1,079,426 EA $3.80 $4,101,819
PRALIDOXIME (6505-01-125-3248) 583,507 EA $7.55 $4,405,478
DIAZEPAM (6505-01-274-0951) 689,788 EA $7.15 $4,931,984
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.30 $6,524,068
0005AC OPTION YEAR TWO TIER PRICING VOLUMES
(3,000,001 TO 6,114,708)
MARK I (6505-01-174-9919) 2,244,762 EA $12.08 $27,116,725
ATROPINE (6505-00-926-9083) 1,079,426 EA $3.93 $4,242,144
PRALIDOXIME (6505-01-125-3248) 583,507 EA $7.80 $4,551,355
DIAZEPAM (6505-01-274-0951) 689,788 EA $7.39 $5,097,533
MORPHINE (6505-01-302-5530) 1,517,225 EA $4.44 $6,736,479
0006 NEW VENDOR VALIDATION
0006AA 1 LT $270,528 270,528
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CONTINUATION SHEET: SP0200-99D-0007 Page 12 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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Variation in Quantity:
Plus or Minus 2%
Inspection and Acceptance:
Origin
FOB:
Origin
Manufacturing and Packaging/Packing Location:
Meridian Medical Technologies, Inc.
0000 Xxxxxxxx Xx.
Xx. Xxxxx, XX 00000
Source of Raw Materials:
Atropine: Boeringer-Ingelheim, Germany
Pralidoxime: Xxxxxxx Xxxxxxxx, Rensselear, NY
Diazepam: SST Corp., Clifton, NJ
Morphine: Mallincroft, St. Louis, MO
Payment Address:
Meridian Medical Technologies, Inc.
00000 Xxx Xxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Guaranteed Minimum:
Delivery Order SP0200-99D-0007-8001 covering the base year annual
services under lines 0001, 0002, and 0006 of the contract will be issued as a
separate document concurrently with the issuance of this basic contract. The
guaranteed minimum for line 0004 (2% of the estimated dollar value of line 0004:
$181,776) will be issued during the base year.
Annual Maximum Order Quantities under line item 0004:
2,899,999 equivalent injectors. Quantities up to 2,400,000 will be priced under
Line 0004AA (AB and AC for option year one and two, respectively). The
additional 499,999 will be priced at the unit prices stated in the contract
schedule.
Delivery:
For items with available pre-stocked components: 30 days after award of delivery order.
For items without available pre-stocked components: 135 days after award of delivery order.
Option Provision:
Option Clause 52.217-9P12 is a part of this contract with two one-year
option periods available at the unit prices stated on the contract schedule
pages. The contracting officer shall give the contractor a preliminary written
notice of intent to extend at least 15 days before expiration of the contract.
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CONTINUATION SHEET: SP0200-99D-0007 Page 13 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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Pre-Stocking of Component Parts:
The Government may purchase component parts for each injector
throughout the life of this contract as excess War Stopper funds become
available. This material shall be purchased against line item 0004 (at the
stated prices shown for Pre-stock). This material shall be stored and rotated by
the contractor to fill given delivery orders. No additional costs for storage
and rotation shall apply.
Government Furnished Material:
The following will be considered Government Furnished Material under
this contract:
1) Expired or extended material shipped to MMT for shelf life
extension in accordance with line item 0002 and Logistics Maintenance/DRB
Program Statement of Work.
2) Material purchased under line item 0004 specifically for
the Army's DRB Program to be stored at MMT in accordance with line item 0003 and
Logistics Maintenance/DRB Program Statement of Work.
3) Material purchased under line item 0004 specifically to
support the Army's Unit Deployment Package (UDP) Potency and Dated (P&D) Program
to be stored at MMT in accordance with Logistics Maintenance/DRB Program
Statement of Work.
4) Components purchased under line item 0004 identified as
pre-stocking components.
Effective Date of Award:
Effective date of Base Year shall be from 1 Aug 1999 through 31 Jul 2000.
The payment schedule will be as follows for Line Items 0001 and 0002:
Value per Month: $809,127.00
24 Payments of: $404,563.50
Invoices for payment of Lines 0001 and 0002 shall be submitted on the 15 and 30
of each month commencing Aug 15, 1999 and ending July 31, 2000.
Line 0006 may be invoiced upon award of this delivery order.
Invoices for Line Item 0004 will be submitted after issuance of each Delivery
Order. The same shall apply for Line Items 0005, if exercised.
Continuation from Block 18 Page 1:
Amendments 0001 through 0004
Contractor Correspondence dated:
29 Jun 1998 Initial offer
15 Jan 1999 Second offer
16 Jul 1999 Revised offer (faxed 7/19/99) 39 Pages
23 Jul 1999 Revised offer (faxed 7/26/99) 33 Pages
29 Jul 1999 Revised offer (faxed 7/29/99) 18 Pages
30 Jul 1999 Correction to Line 0001 (Option 1 and 2)
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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Mobilization Surge Cost Reconciliation Procedure
A full cost accounting and reconciliation against xxxxxxxx is required upon
completion of a declared Mobilization Surge (MS).
The procedure is as follows:
1. Declaration and Termination:
a. Mobilization Surge (MS) will be officially declared via a
Delivery Order from DSCP requesting products under CLIN 0005 for
immediate delivery under Mobilization Surge provisions. MMT will
immediately become obligated to terminate in a reasonable fashion
production for non-DoD customers and proceed as rapidly as
possible to devote all production resources to manufacture and
deliver the requested MS products. CLIN 0001 payments shall
continue IAW the original contract payment schedule after MS has
been declared. If the MS continues after eight (8) CLIN 0001
biweekly payments have been made, CLIN 0001 payments shall then
be suspended for the duration of the MS. CLIN 0001 payments shall
resume IAW the original contract payment schedule upon the
termination of the MS.
b. Termination of Mobilization Surge requires written confirmation from
DSCP. Termination notification is expected to be noted on the last MS Delivery
Order. However, DSCP may terminate MS by separate written notification to the
Contractor. Since MMT will likely be in a full production, 3 shift operation,
notification of Mobilization Surge termination will be received prior to
completion and delivery of the last quantities requested on a Mobilization Surge
Delivery Order. This prompt notification will allow for orderly phase down and
return to commercial production. If CLIN 0001 payments were suspended in
accordance with paragraph 1.a. immediately above, CLIN 0001 payments shall
resume IAW the original contract payment schedule upon the termination of the
MS. NOTE: Failure to provide timely MS termination notice may result in
additional charges billable to DoD for idle time and idle facilities.
2. Accounting for Mobilization Surge (MS):
a. To determine the full cost of Mobilization Surge, costs incurred for
MS from the initial MS Delivery Order through the later of delivery of the final
MS Delivery Order or notice of the termination of MS, shall be treated as a
single "job-order" under a job-order costing system. The "job-order" will
accumulate the full MS cost for all MS production made during the surge; i.e.,
the full accounting during MS adjusted for any non-MS production. Cost to
complete production lots in progress at the time Mobilization Surge is started
will be deducted from the total costs during MS. Likewise, cost continuations
beyond termination of MS which are the result of MS will be charged to the MS.
b. Cost will be accumulated and summarized in a format consistent with
the CLIN 0005 cost proposal. Product cost will include manufacturing variances
against standards. Variances attributable to non-DoD production will be excluded
from the MS costing.
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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3. Reconciliation of cost against xxxxxxxx and settlement of charges:
a. MS total costs will consist of the full costs incurred, (and
accounted for in accordance with Section 2.a. above), for MS from implementation
to the later of delivery of the final MS Xxxxxxxx Order or notice of the
termination of MS, plus any costs incurred (idle time and idle facilities) due
to failure of timely termination of MS.
b. Progress payments for Direct Materials will be liquidated against
invoiced product.
c. Amounts due will result when total actual incurred costs, including
costs incurred (idle time and idle facilities) from untimely MS termination,
exceed the total payments. The Government's maximum liability for Mobilization
Surge may not exceed the combined value of product ordered during the MS at the
CLIN 0005 prices and the total amount available under CLIN 0001 Base Maintenance
for the entire duration of the MS. A refund will result if total payments exceed
actual costs incurred. Refund will be limited to CLIN 0001 payments less any
costs (idle time and idle facilities) of untimely termination.
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ADJUSTMENT OF COST OF PRALIDOXIME CHLORIDE IN MARK I KITS AND
PRALIDOXIME
(a) This clause applies only to the CLIN 0004 (both up to and beyond 2.4
million equivalent Autoinjectors), CLIN 0005, and Prestock contract
prices for Mark I Kits and Pralidoxime (a/k/a Combopen or 2-Xxx) for
each contract year as listed in Section B, Schedule of Supplies and
Services. These unit prices may be adjusted upward or downward as
appropriate.
(b) The contract award prices for these items were based on the most
current, accurate and complete information available at the time of
award. These contract award prices are firm-fixed priced for the Base
Year and Option Years One and Two except for the costs outlined in
paragraph (c) below.
(c) At the time of contract award, the Direct Material cost of Pralidoxime
Chloride in Mark I Kits and Pralidoxime anticipated in the performance
of this contract could not be established with any reasonable certainty
due to ongoing negotiations between Meridian Medical Technologies, Inc.
(MMT) and their new Pralidoxime Chloride supplier, Nycomed Amersham
Imaging Americas (Nycomed). It is hereby agreed that the Direct Material
cost of Pralidoxime Chloride per Mark I Kit and per Pralidoxime shall be
subject to one adjustment under this clause. It is further agreed that
the adjustment will be limited to the change in the Direct Material cost
of Pralidoxime Chloride per Mark I Kit and per Pralidoxime with no
adjustment for Material Handling, Variable Overhead, Plant Overhead,
Corporate Overhead/General and Administrative (G & A), and Profit. The
contract award prices for these items were based on the most recent
written quote provided to the Government by MMT, i.e., Xxxxxxx's quote
of April 6, 1998 of $516.56 per kilogram of Pralidoxime Chloride. The
Direct Material cost of Pralidoxime Chloride at each quantity/price tier
in the negotiated contract prices for Mark I Kits and Pralidoxime was
determined by entering that quote on a per gram basis into the
negotiated Component Quotations furnished by MMT in support of Component
Cost and Detail Schedules H and J. The calculation and the value of the
Direct Material cost of Pralidoxime Chloride at each quantity/price tier
for Mark I Kits and Pralidoxime for each contract year currently
included in the contract prices are shown on the attached schedules
entitled "Effect of Pralidoxime Chloride Costs" and "Material Cost".
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CONTINUATION SHEET: SP0200-99D-0007 Page 17 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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(d) When MMT and their supplier reach an agreement on the price(s) for
Pralidoxime Chloride, MMT shall furnish a copy of said agreement to the
Contracting Officer. To determine the adjusted Direct Material cost of
Pralidoxime Chloride at each quantity/price tier for Mark I Kits and
Pralidoxime for each contract year, the newly negotiated price for
Pralidoxime Chloride applicable to each contract year shall be entered
on a per gram basis into the schedule entitled "Effect of Pralidoxime
Chloride Costs." For each quantity/price tier for Mark I Kits and
Pralidoxime for each contract year, the increase or decrease (carried or
rounded to five decimal places) in Direct Material cost of Pralidoxime
Chloride from that included in the contract prices (as shown on the
attached schedule entitled "Material Cost") will be calculated. That
increase or decrease will then be added to or subtracted from (as
appropriate) the contract award total unit price (carried or rounded to
five decimal places) for each quantity/price tier for Mark I Kits and
Pralidoxime for each contract year. The resulting unit prices will then
be rounded to the nearest cent to establish the adjusted contract unit
prices
(e) Once the adjusted contract prices are determined, the Contracting
Officer shall issue a modification adjusting the unit prices for all
three contract years for Mark I Kits and Pralidoxime for CLIN 0004 (both
up to and beyond 2.4 million equivalent Autoinjectors), CLIN 0005, and
Prestock. The modification shall include the adjusted unit prices and
all calculations used to determine the adjusted unit prices. All
delivery orders issued on or after the date of this adjustment
modification shall be priced at the adjusted contract unit prices.
Payment on this contract shall be at the contract award prices pending
issuance of the adjustment modification. The modification establishing
the adjusted contract unit prices or a subsequent modification shall (as
appropriate) increase or reduce payment under this contract for all
delivery orders of Mark I Kits and Pralidoxime issued prior to the
effective date of the adjustment modification. Price adjustment will not
apply to any quantities under this contract that have already been
shipped.
End of clause
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CONTINUATION SHEET: SP0200-99D-0007 Page 18 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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Combopen
-----------------------------------------------------------
1 thru 500,000 750,000 1,000,000 over
Quantity 499,999 749,999 999,999 1,200,000 1,200,000
-----------------------------------------------------------
Base Year Costs
---------------
Other Material 2.48052 2.34552 2.28053 2.23845 2.23845
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 2.96063 2.81086 2.73848 2.69271 2.69271
======= ======= ======= ======= =======
Option 1 Costs
--------------
Other Material 2.56734 2.42761 2.36035 2.31679 2.31679
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 3.04745 2.89295 2.81830 2.77105 2.77105
======= ======= ======= ======= =======
Option 2 Costs
--------------
Other Material 2.65720 2.51258 2.44296 2.39788 2.39788
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 3.13731 2.97792 2.90091 2.85214 2.85214
======= ======= ======= ======= =======
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CONTINUATION SHEET: SP0200-99D-0007 Page 19 of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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Xxxx X
-----------------------------------------------------------
1 thru 500,000 750,000 1,000,000 Over
Quantity 499,999 749,999 999,999 1,200,000 1,200,000
-----------------------------------------------------------
Base Year Costs
---------------
Other Material 4.13684 3.95693 3.84692 3.78005 3.78005
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 4.61695 4.42227 4.30487 4.23431 4.23431
======= ======= ======= ======= =======
Option 1 Costs
--------------
Other Material 4.28163 4.09542 3.98156 3.91235 3.91235
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 4.76174 4.56076 4.43951 4.36661 4.36661
======= ======= ======= ======= =======
Option 2 Costs
--------------
Other Material 4.43149 4.23876 4.12092 4.04928 4.04928
Pral. Chlor Cost 0.48011 0.46534 0.45795 0.45426 0.45426
------- ------- ------- ------- -------
Total DM 4.91160 4.70410 4.57887 4.50354 4.50354
======= ======= ======= ======= =======
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CONTINUATION SHEET: SP0200-99D-0007 Page 19 A of 34
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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1 to 500000 to 750000 to 1000000 to OVER
499999 units 749999 units 999999 units 1200000 units 1200000 units
------------ ------------ ------------ ------------- -------------
Pral. Chlor Requirements 278,832 450,421 664,907 879,394 1,055,273
Pral. Chlor Unit Price [0.51656] 0.51656 0.51656 0.51656 0.51656
---------- ---------- ---------- ------------ ------------
Total Pral Chlor per Production Batch 144,033.46 232,669.47 343,464.36 454,259.76 545,111.82
Divided by number of units produced 300,000.00 500,000.00 750,000.00 1,000,000.00 1,200,000.00
---------- ---------- ---------- ------------ ------------
Pral. Chlor price per product unit 0.48011 0.46534 0.45795 0.45426 0.45426
========== ========== ========== ============ ============
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CONTRACTOR: MERIDIAN MEDICAL TECHNOLOGIES INC.
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PROGRESS PAYMENTS
If Mobilization Surge is officially declared via a Delivery Order from DSCP for
products under CLIN 0005 for immediate delivery pursuant to the Mobilization
Surge provisions of this contract, Progress Payments are authorized for only
Direct Material costs incurred in the performance of the Mobilization Surge, by
Meridian Medical Technology, and supported by vendor invoices. Progress Payments
will cease upon written notification to Meridian Medical Technology that the
Mobilization Surge is ended.
The following additional clauses are hereby incorporated by reference and apply
only to Direct Material costs incurred for CLIN 0005 end items ordered pursuant
to the Mobilization Surge provisions of this contract:
52.232-16 Progress Payments (Jul 1991) ALTERNATE 1 (Aug 1987)
252.232-7004 DOD Progress Payment Rates (Feb 1996) DFARS
The following clauses are also included by reference:
52.233-1 Disputes (Oct 1995) ALTERNATE 1 (Dec 1991)
52.215-17 Waiver of Facilities Capital Cost of Money (Oct 1997)
Funds from this contract pay the salary expenses of most of Meridian's NAA labor
force and a significant portion of NAA plant overhead. Therefore, for the
duration of this contract and unless otherwise authorized in writing by the DSCP
Contracting Officer, the contractor shall not accept orders for autoinjectors
for the US military unless those orders are placed by DSCP under this contract.
If contractor has any non-DoD federal agency sales for the items covered under
this contract, then the price charged to that agency (s) shall not be less than
two (2) times the price established in Line Item 0004.
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STATEMENT OF WORK
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Base Maintenance (Line Item 0001)
Page 1 of 5
I. This is a supply/service contract to provide labor and services as necessary
and directed by the Government and in accordance with the enclosed Statement of
Work and the DoD Industrial Preparedness Program Production Planning Schedule.
II. The Contractor agrees from the effective date of contract to perform the
following:
a. Maintain existing facilities and equipment and technical expertise
in a state of readiness for immediate production start up to achieve the
Government's current mobilization requirements, as set forth in the Contractor's
Industrial Preparedness Planning Agreement (DD Form 1519) for the
following products:
NSN: 6505-01-174-9919 Antidote Kit, Nerve Agent, Mark I
NSN: 6505-01-125-3248 Pralidoxime Chloride Injection, Automatic,
300 mg per ml, 2 ml
NSN: 6505-00-926-9083 Atropine Injection, Automatic, 2 mg
NSN: 6505-01-274-0951 Diazepam Automatic Injector, USP, 10 mg
NSN: 6505-01-302-5530 Morphine Sulfate Injector, 10 Mg per 0.7 Xx
x. Maintain in readiness the following tasks, functions and activities
to produce the above cited products:
1) An aseptic sterile production facility in accordance with
the Federal Food, Drug and Cosmetic Act and regulations promulgated thereunder
including FDA's current good manufacturing practices.
2) A cleaning and preparation of piece parts function required
for assembly as relates to aseptic sterilization production.
3) A product formulation department consistent with the
products processing requirements and to exercise the formulation process for the
Atropine, Pralidoxime, Diazepam, and Morphine Injection solutions on a periodic
basis that validates the capability to produce the products in compliance with
all regulatory, technical and quality assurance specifications; the current
technical packages for the above cited products, as of the effective date of
this contract, are incorporated into the solicitation.
4) A clean room and product filling operation.
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STATEMENT OF WORK
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Base Maintenance (Line Item 0001)
Page 2 of 5
5) An inspection, assembly, labeling and packaging capability
to effectively meet the Government's mobilization requirements.
6) A warehouse facility to insure adequate control and
accountability of new supplies and materials during the receipt, storage and
issue phases and of components and fully assembled injectors being
stored/rotated for the Government.
7) A quality assurance and FDA regulatory compliance function
to insure compliance with all quality and performance requirements of the
applicable specifications and the Government's "shelf life enhancement" program
for all products.
8) A cost accounting system in accordance with generally
accepted accounting principles that will be acceptable to the Government to
insure trackability of contractor costs.
9) A qualified management team, supervisory staff and
administrative personnel to insure effective and efficient operation of the
Contractor's facilities.
10) An acceptable training program to insure that qualified
skill levels are retained in order to meet the Government's mobilization
requirements.
11) Sub-contractor business relationships to insure that the
necessary sub-contractor's production capability, capacity, technical expertise
and management commitment will meet the Contractor's Industrial Preparedness
Planning Agreement
provisions.
c. Dedicate those best efforts to maintain a qualified sub-contractor
component base for the manufacture of components and sub-components needed to
produce the end items.
d. In the event that prime contractor-owned component molds, tooling
and assembly molds, pre-positioned at various subcontractor plants, require
replacement, the Contractor will replace or issue a contract to replace these
items at no additional cost to the Government. Furthermore, the Contractor
agrees that in the event of a third party or other said agreements, the
Contractor, or the liable third party, agrees to replace, repair, or refurbish
all Contractor owned molds, tooling and assembly molds prepositioned at various
sub-contractor's plants at no additional cost to the Government.
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STATEMENT OF WORK
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Base Maintenance (Line Item 0001)
Page 3 of 5
e. In the course of performing said labor and services in accordance
with Statement of Work, the Contractor will produce an end item product listed
as line item 0004 of the schedule to the services performed. The Government
recognizes these incidental products to be, but not limited to, the following:
NSN: 6505-01-174-9919 Antidote Kit, Nerve Agent, Mark I
NSN: 6505-01-125-3248 Pralidoxime Chloride Injection, Automatic,
300 mg per ml, 2 ml
NSN: 6505-00-926-9083 Atropine Injection, Automatic, 2 mg
NSN: 6505-01-274-0951 Diazepam Automatic Injector, USP, 10 mg
NSN: 6505-01-302-5530 Morphine Sulfate Injector, 10 Mg per 0.7 Xx
x. The Contractor agrees to advise the Government through the
Contracting Officer of changes which may or will adversely impact production
capability to meet the production rate and schedule requirements of the current
mobilization planning agreement. The Contractor shall advise the Contracting
Officer of changes required to the agreement and/or proposals which may
favorably impact the Government and/or the contractor from achieving
mobilization production delivery requirements.
g. The Contractor also agrees to enter into future yearly Industrial
Preparedness Agreements with the Government covering the above cited products
for the duration of this
contract.
III. Required standards of workmanship:
a. Unless otherwise specifically provided in this contract, the quality
of all services rendered hereunder shall conform to the highest standards in the
relevant profession, trade or field of endeavor. All services shall be rendered
or supervised directly by individuals fully qualified in the relevant
profession, trade or field, and holding any licenses required by law.
b. The Defense Supply Center Philadelphia (DSCP) reserves the option to
conduct in-process reviews (IPRs) at the Contractor's facility. These must be
scheduled by DSCP personnel at least seven (7) days in advance of the IPR.
Requests for IPRs by any other personnel will be referred to DSCP.
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STATEMENT OF WORK
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Base Maintenance (Line Item 0001)
Page 4 of 5
Packaging and Marking
---------------------
1. Marking of Reports
All reports shall prominently show on the cover of the report:
a. Name and business address of the contractor.
b. Contract number.
2. Preparation for Delivery (Incidental Product - End Item)
Preparation for delivery shall be in accordance with Section 5 of the end item
specification, the latest edition at time of manufacture, required by Section C
of the contract.
Inspection and Acceptance
-------------------------
1. Inspection of Services
Definition "Services", as used in this clause, includes services performed,
workmanship, and material furnished or used in performing services.
2. Inspection and Acceptance
a. Inspection and acceptance of services to be furnished hereunder
shall be made, upon completion of the services, by DCMC Saint Louis. Inspection
and acceptance of material shall be made by FDA Kansas City.
b. The Contractor shall provide and maintain an inspection system
acceptable to the Government covering services under this contract in accordance
with all Federal Food Drug and Cosmetic Act and regulations. Complete records of
all inspection work performed by the Contractor shall be maintained and made
available to the Government during contract performance and for as long
afterwards as the contract requires.
c. The Government has the right to inspect and test all services called
for by the contract, to the extent practicable at all places and times during
the term of the contract.
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STATEMENT OF WORK
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Base Maintenance (Line Item 0001)
Page 5 of 5
The Government shall perform inspections and tests in a manner that will not
unduly delay the work.
d. If any of the services performed do not conform with contract
requirements, the Government may require the Contractor to perform the services
again in conformity with the contract requirements, for no additional fee. When
the defects in services cannot be corrected by re-performance, the Government
may (1) require the Contractor to take necessary action to ensure that future
performance conforms to contract requirements, and (2) reduce any fee payable
under the contract to reflect the reduced value of the services performed.
e. If the Contractor fails to promptly perform the services again or
take the necessary actions to ensure future performance in conformity with the
contract requirements, the Government may (1) by contract or otherwise, perform
the services and reduce any fee payable by an amount that is equitable under the
circumstances or, (2) terminate the contract for default.
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STATEMENT OF WORK
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LOGISTICS MAINTENANCE AND DRB PROGRAM (LINE ITEMS 0002 AND 0003)
Page 1 of 9
1. Background
The Army has established several programs to centrally manage Medical Chemical
Defense Materiel (MCDM). USAMMA has been designated as the Program Manager for
these programs.
2. Description of Work Required
Manufacturing of new MCDM and the storage of materiel (both new and extended
materiel). The storage requirement encompasses receipt processing, storage (i.e.
vault, refrigeration, controlled room temp), record keeping, Care of Supplies in
Storage (COSIS), remarking, assembly, packing, and shipment.
A. The Army intends to store:
(1) A maximum of 3 DRBs of new materiel (not extended materiel).
Each DRB consists of 15,000 Mark I Kits, 5,000 CANA and
1,000 packages of PBT.
(2) 1 DRB of extended materiel that has been remarked.
(3) MCDM to support the Unit Deployment Package (UDP) Potency
and Dated (P&D) Program. The items under this program are
the Atropine, Diazepam, and Pralidoxime Auto-injectors. This
material will be remarked as it is extended.
(4) MCDM in the Shelf Life Extension Program (SLEP). This
materiel will only be remarked as required.
B. The following NSNs apply to the MCDM covered by this SOW:
(1) Antidote Kit Nerve Agent, (Mark I Kits, NAAK) NSN
6505-01-174-9919 (consists of one Atropine and one
Pralidoxime Chloride Injector)
(2) Diazepam Injector (CANA) NSN 6505-01-274-0951
(3) Pyridostigmine Bromide Tablets (PBT or NAPP) NSN
6505-01-178-7903 (consisting of 210 tablets per Package)
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STATEMENT OF WORK
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LOGISTICS MAINTENANCE AND DRB PROGRAM (LINE ITEMS 0002 AND 0003)
Page 2 of 9
(4) Atropine Autoinjector NSN 6505-00-926-9083
(5) Pralidoxime Chloride Injection (2-Xxx) NSN 6505-01-125-3248
(6) Morphine Sulfate Injector, 10 Mg per 0.7 Ml NSN
6505-01-302-5530
3. Manufacturing
Based on receipt of funded Army requisitions passed through the Defense Supply
Center Philadelphia (DSCP), the contractor shall produce the required materiel
(Delivery Orders for this material will be issued under Line Item 0004).
Material required to fill regular requisitions shall be shipped to a DLA depot
specified in the order. Xxxxxxxx manufactured for the UDP P&D Program will
remain at the contractor's facility. DRB materiel will either be shipped to the
activity, DLA depot or retained at the contractor's facility as part of the
three DRBs of new materiel. A maximum of three different lot numbers can be
provided for each 15,000 Mark I Kits and two different lot numbers can be
provided for each 5,000 CANA (1 DRB's worth). Ideally only one lot number would
be shipped for each DRB. If the contractor must produce additional lots of Mark
I Kits and CANA to satisfy this requirement, the Government has no
responsibility or liability to procure these additional quantities. Any
deviation from this requirement for minimum lots must be approved in writing by
USAMMA, MCMR-MMS-M.
Work must be consistent with good business practices and government regulations.
After 90 days of contract award, or implementation of an option to the contract,
the quantity of Army/OTSG MCMD reflected in USAMMA's accountable records (as
reflected in the MCDM database) must match the quantity of MCDM physically on
hand (in inventory) at the contractor's site.
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STATEMENT OF WORK
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LOGISTICS MAINTENANCE AND DRB PROGRAM (LINE ITEMS 0002 AND 0003)
Page 3 of 9
4. Storage of Army Owned MCDM
A. Receipt Processing
(1) In addition to the MCDM currently on-hand at the
contractor's facility, the contractor will accept annually
the below quantities. Quarterly shipments will be on average
1/4 of the yearly amount stated.
(a) 600,000 Mark I Kits (NSN 6505-01-174-9919) and/or stand
alone autoinjectors of Atropine and 2-Xxx (NSNs
6505-00-926-9083 and 6505-01-125-3248).
(b) 200,000 CANA (NSN 6505-01-274-0951). However, due to
limited secure storage the maximum number of CANA that
can be stored is approximately 576,000 EA.
(c) 40,000 Packages of PBT (NSN 6505-01-178-7903). However,
due to limited refrigerated storage the maximum number
of PBT that can be stored is approximately 109,560
Packages.
(2) Materiel will be shipped to the contractor in quarterly
shipments to be placed in the Industrial Base Maintenance
Contract (IBMC) for the life of the contract. USAMMA,
MCMR-MMO, will provide 30 days advance notification to the
contractor of expected shipments of materiel. Contractor has
30 working days to inventory incoming shipments. Contractor
will request extension from USAMMA (MCMR-MMO) if additional
time is required.
(3) If necessary, substitution may be made for the shipment and
quantity of one item for another item. For example, in lieu
of shipping 10,000 of PBT during a quarterly shipment, the
Army can substitute 10,000 CANA, Xxxx Xx, Atropine or 2-Xxx.
(4) Army will request that activities not send loose materiel
mixed together to the contractor. In the event the
contractor receives loose shipments, the contractor will
place the materiel on a shelf, and notify USAMMA, MCMR-MMO.
During the quarterly site visit, USAMMA, MCMR-MMO, will
provide appropriate guidance for the loose materiel.
(5) Contractor will forward USAMMA, MCMR-MMO, copies of any DD
Forms 1348-1 received with shipments.
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B. Storage
(1) Mark I Kits, Atropine and 2-Xxx requires room temperature
storage with approximately 59-86 degrees Fahrenheit or 15-30
degrees Celsius and should not be allowed to freeze. Mark I
Kits received (above the requirements for the 3 new and 1
extended DRB) will be broken down by separate components.
Usable pouches and clips will be stored in case the Mark I
Kits would need to be assembled from extended materiel to
support a contingency. Quantity of pouches and clips should
not exceed the number of individual extended Atropine/2-XXX
on hand.
(2) CANA requires special storage due to its note Q rating
(safekeeping in a safe or vault) and temperature control of
59-86 degrees Fahrenheit or 15-30 degrees Celsius.
(3) PBT requires refrigeration between 35-46 degrees Fahrenheit
or 2-8 degrees Celsius. Moreover, PBT cannot be outside of
refrigerated conditions for more than a cumulative period of
six months. Therefore, the contractor shall assure this item
is continuously stored in refrigeration except when USAMMA
directs the assembly/shipment of materiel. Note: The
contractor will not be responsible for the referenced
cumulative period, since the material has been in the
possession of others prior to arriving at the contractor's
location.
(4) All MCMD will be segregated by lot number and activity until
inventory is verified by MCMR-MMO. Lots will be stored in a
manner that will ensure materiel from one lot can not be
confused with any other lot in the container. Lot integrity
will be maintained at all times following MCMR-MMO
inspection.
(5) The new DRB materiel will be kept separate from the extended
DRB materiel, other material being stored at the
contractor's location and the UDP P&D materiel.
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(6) Contractor has elected not to store the DRB material in the
TRI-Walls. TRI-Walls currently on hand shall be shipped to:
SR USAMMA
Bldg 000
000 Xxxxxxxx Xxxx
Xxxxx Xxxxx, XX 00000-0000
DODAAC: W90KEW
C. Record Keeping
Accurate data from receipt processing will be loaded into the
contractor's ACCESS/EXCEL database within 15 days after completion of
the inspection and inventory.
(1) Contractor will maintain a database of all Army owned
materiel stored. The database will reflect the NSN,
nomenclature, manufacturer, quantity, lot number, activity
who shipped the materiel, expiration date, an indicator if
materiel has been extended, ship date, and receipt date.
(2) Contractor shall provide a copy of the ACCESS/EXCEL database
on a quarterly basis to USAMMA (both MCMR-MMO and
MCMR-MMS-M) via electronic mail using existing software.
Updates should be provided after the data has been modified
based on the quarterly shipments.
(3) USAMMA will provide the contractor copies of the FDA reports
for materiel in the SLEP. Codes on the report will indicate
if the materiel has been extended or failed testing.
(4) USAMMA will furnish the contractor a copy of the EXCEL
database on a quarterly basis.
(5) USAMMA will provide lot numbers and quantity of materiel to
be sent for destruction. Product will be scheduled and
shipped for destruction within 90 days after materiel failed
FDA testing. If only a small quantity has failed (i.e., less
than 1,000 units total), this materiel may be held and
accumulated until an economical quantity is available for
destruction. Shipment should occur within 30 days of
verification by the contractor that the materiel has been
staged and quantities and lot numbers verified.
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(a) USAMMA will be fully responsible for all costs
associated with the destruction of Army owned MCDM.
Unless, the contractor reclaims the components of an
injector (with the exception of the Mark I pouches and
clips), the contractor shall be responsible for the
disposal of the remaining components and active
ingredient. Contractor will provide USAMMA, MCMR-MMO
documentation citing that the active ingredient was
destroyed IAW the local, state and federal regulations.
(b) USAMMA, MCMR-MMO will be responsible for funding and
coordinating the shipments for destruction and for
obtaining a Certificate of Destruction. MCMR-MMO will
provide the contractor with a copy of the Certificate
of Destruction for Controlled Substances upon
destruction of these items.
D. Government Visits
The contractor shall agree to allow USAMMA's Strategic Capabilities and
Materiel Directorate (MCMR-MMS-M) and/or the Operations and Support
(MCMR-MMO) COTRs to inspect, inventory, and audit all Government owned
property at any time (at least quarterly) throughout the period of the
contract. These inspections will be directed by the Contracting
Officer, but may be requested by the COTR. If during such inspection
(audit) the on-hand quantity is less than indicated in the MCDM
database, USAMMA will select one of two replacement alternatives:
(a) The contractor replaces in kind all shortages within 20
weeks.
(b) The contractor reimburses the Government in full within
20 days.
USAMMA retains the right to choose the replacement alternative based
upon the needs of the Government at the time.
E. Over-label
(1) The DRB of extended materiel shall be remarked with the
latest expiration date, i.e. month/year as instructed by the
COTR. Lot numbers within the DRB will be limited to a
maximum of 3 for the Mark I Kits and 2 for the CANA.
Ideally, only one lot number will be allocated for the
extended DRB.
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(2) The MCDM for the UDP P&D program will require over-labeling
with the latest expiration date, i.e. month/year.
(3) Other MCDM will be over-labeled on an as required basis. 30
days advance notice will be provided.
(4) Due to the potential recall requirements, when
over-labeling, the contractor will at no time combine
separate lots to make larger lots.
(5) The over-label will always contain the original NSN,
Manufacturer, and lot number. The only change to the
over-label will be the new expiration date. Whenever any
MCDM is over-labeled, USAMMA will be immediately notified
with the actual number of assets of extended/issuable
material. This shall take into account the units which are
held for QC, not to exceed 5 per lot, and the numbers of
units lost as rejects.
(6) Only lot sizes of 1,000 (+) units will be considered
candidates for over-labeling. Contractor will first
over-label lots which are 5,000 (+) units. Once lot sizes of
5,000 (+) have been over-labeled, contractor will over-label
smaller lots.
(7) Contractor will only over-label MCDM which contractor has
manufactured.
F. Assembly/Packing/Shipping
(1) The DRB and UDP P&D MCDM will need to be assembled, packed
and received at a consolidation point within 72 hours after
notification during an contingency situation. This includes
weekends. USAMMA (either MCMR-MMO or MCMR-MMS-M) will
provide the quantity, type, ship to destination, and other
applicable details. Transportation funding for the DRB
shipment would be provided by USAMMA, MCMR-MMS-M.
Transportation funding for the UDP P&D materiel will be
provided by DSCP. Packing, packaging, and storage will be to
a degree of protection that precludes loss, damage, or
destruction to containers and contents under normal
transportation.
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(2) Assembly steps will ensure that only those lots and
quantities required are packed and prepared for shipment.
Lot integrity will be maintained at all times. Under no
circumstances will MCDM materiel from different lot be
placed loosely in containers and shipped. If more than one
lot is placed in a container, lots will be packaged so as to
ensure materiel from one lot could not be confused with any
other lot in the container.
(3) Assembly/packing and shipment of MCDM (including UDP P&D
material) in support of non-emergency situations will be
accomplished within 10 calendar days after receipt of
request.
(4) Shipment will occur by Government Bill of Lading (GBL) and
will conform to applicable Defense Transportation System
(DTS) and commercial carrier rules and regulations. Materiel
shall be packaged in accordance with (IAW) commercial
practices, and intermediate package(s) and shipping
container(s) shall be marked IAW MIL-STD-129. Contractor
shall be a Procedure A Contractor.
(5) The contractor shall coordinate and make arrangements with
commercial firms specializing in overnight or rapid
delivery, as well as the Defense Transportation System
(DTS), for the timely shipment of DRB and MCDM within the
United States.
(6) Shipment of materiel to the FDA for shelf life testing will
be processed for shipment within 10 days from receipt of
request from USAMMA, MCMR-MMO.
(7) The MCDM that requires over-labeling before shipment will be
processed and shipped within 60 days after receipt of
request.
G. Testing
USAMMA, MCMR-MMS-M, will test the contractor's ability to provide MCDM
to a designated consolidation point within 72 hours. Such tests could
range from simply a paper exercise to the packing and shipment of
actual MCMD to selected locations anywhere in the world. USAMMA plans
to perform these drills twice a year. Further, at the direction of
USAMMA, MCMR-MMS-M, DTS will also be used to ship MCDM.
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H. Contractor's Documentation Requirements.
Within 30 days of execution of the agreement to which this Statement of
Work is applicable, the Program Manager for these programs as defined
in section 1 of this Statement of Work, must provide to Contractor
coordination documentation reflecting FDA's approval process for the
Shelf-Life Extension Program, to include, but not limited to,
o a Memorandum of Understanding or any other formal agreement among
the parties
o product testing procedures and guidelines
Contractor will be provided with copies of any updates or changes to
the referenced documentation.
USAMMA shall continue to provide copies of the documentation received
from FDA regarding extended product as stated in paragraph 4.C.(3) of
this Statement of Work.
