Exhibit 10.1

 

AWARD/CONTRACT

 

1. THIS CONTRACT IS A RATED ORDER

[g12291kk01i001.jpg]

 

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:

[g12291kk01i001.jpg]

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

[g12291kk01i001.jpg]

 

$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

 

QUANTITY

 

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).

 

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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).

 

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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

 

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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

 

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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

 

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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.

 

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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.

 

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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 [g12291kk23i001.jpg]

2

3

0

 

 

G. PREPARED BY

E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY

[g12291kk23i002.jpg]

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 [g12291kk25i001.jpg]

2

3

0

 

 

G. PREPARED BY

E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk25i002.jpg]

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 [g12291kk27i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk27i002.jpg]

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 [g12291kk29i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk29i002.jpg]

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[g12291kk31i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk31i002.jpg]

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[g12291kk33i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk33i002.jpg]

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 [g12291kk35i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk35i002.jpg]

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 [g12291kk37i001.jpg]

2

3

0

 

 

G. PREPARED BY
E. J. Wagar
MAJ, U.S. Army

H. DATE

27 NOV 2007

I. APPROVED BY
[g12291kk37i002.jpg]

J. DATE

NOV 27 2007

 

 

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

                                                                                                                                                                                                                                    Adobe
Professional 7.0

 

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

 

[g12291kk39i001.jpg]

 

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

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

 

[g12291kk39i001.jpg]

 

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

 

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

August 10, 2007

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

 

2.1-1a

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

 

[g12291kk39i002.jpg]

 

Attachment 1
W9113M-08-C-0028
Page 3 of 15

 

 

Solicitation Number: W9113M-07-R-0002

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

 

 

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

 

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

August 10, 2007

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

 

2.1-1b

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

 

[g12291kk39i001.jpg]

 

Attachment 1
W9113M-08-C-0028
Page 4 of 15

 

 

Solicitation Number: W9113M-07-R-0002

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

 

 

[g12291kk39i003.gif]

 

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.

 

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

 

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

 

2.1-2

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Product Name

IND Number

Disease Category

Indication

Clinical Status

Prochymal™

BB-IND-7939

Immune

grade II-IV acute  GvHD

Phase II completed

Prochymal™

BB-IND-7939

Immune

treatment refractory acute  GvHD

Phase II completed

Prochymal™

BB-IND-7939

Immune

steroid refractory acute  GvHD

Phase III initiated

Prochymal™

BB-IND-12770

Immune

Crohn’s Disease

Phase II completed

Provacel™

BB-IND-10419

Cardiovascular

myocardial infarction

Phase I completed

Chondrogen™

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
Prochymal™ and currently manufactures Prochymal™ 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”

 

[g12291kk39i004.jpg]

 

 

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
Prochymal™ for the treatment of GvHD is also relevant for use as a release assay
for Prochymal™ 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.

 

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on the title page of this proposal.

 

2.1-4

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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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on the title page of this proposal.

 

2.1-4a

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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 Prochymal™ will support a BLA
filing for the use of Prochymal™ 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 Prochymal™ therapy for
the treatment of radiation-induced enteropathy.

 

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2.1-5

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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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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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2.1-6

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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.

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August 10,
2007                                                                                                                                                                                  

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on the title page of this proposal.

 

2.1-7

 

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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 Prochymal™-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 Prochymal™
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.

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2.1-8

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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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on the title page of this proposal.

 

2.1-8a

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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.

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2007                                                                                                                                                                                  

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on the title page of this proposal.

 

2.1-9

 

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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.

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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

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