15B, SUPPLIES/SERVICES

1 THIS CONTRACT IS A RATED ORDER UNDER

 DPAS (15 CFR 700)

PAGE OF PAGES      

1      |      12      

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

W911QY-12-C-0117

3. EFFECTIVE DATE

 23 Aug 2010

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

W56QTY2199N009

  ACC-APG NATICK DIVISION

  1564 FREEDMAN DRIVE

  FORT DETRICK MD 21702

   DMCA

   DCMA SEATTLE

   188 106TH AVE, NE SUITE 660

   BELLEVUE WA 98004-8019

(4 copies unless otherwise specified) TO

THE ADDRESS SHOWN IN:

JPM-TMT

10109 Gridley Road, bldg 314, 2ND FLOOR

FT. BELVOIR VA 22060-5865

      DFAS-COLUMBUS CETER WESTERN ENTITLEMENT

      PO BOX 182381

      COLUMBUS OH ###-###-####

[      ] 10 U.S.C. 2304(c) (      )     [      ] 41 U.S.C. 253(c) (      )

15B, SUPPLIES/SERVICES

    15C. QUANTITY    

  15D. UNIT  

  15E. UNIT PRICE  

(X)

SEC.

DESCRIPTION

    (X)    

DESCRIPTION

/s/ Chris Garabedian

/s/ Sandra J. O’Connell

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is usable

STANDARD FORM 26 (REV. 4/2008)

Prescribed by GSA — FAR (48 CFR) 53.214(a)

0001

IM Formulation Feasiblity Study

CPFF

FOB: Destination

  PURCHASE REQUEST NUMBER: W56QTY2199N009

ACRN AA

CIN: W56QTY2199N0090001

INSPECT AT

INSPECT BY

ACCEPT AT

ACCEPT BY

0001

52.246-9

DELIVERY DATE

SHIP TO ADDRESS

JPM-TMT

.

10109 GRIDLEY ROAD, BLDG 314, 2ND FLOOR

FT. BELVOIR VA 22060-5865

703 ###-###-####

FOB: Destination

DCAA Auditor

DoDAAC

Email

Phone

Job Title

Statement of Work

Conduct internal management and functional group meetings to ensure timely program schedule execution, compliance with budgetary constraints, and FAR and DFAR compliance in support of program objectives.

Statement of Work

Conduct and/or ensure Sarepta participation in external management meetings with contract service providers to ensure timely program schedule execution, compliance with budgetary constraints, and relevant and FAR and DFAR compliance in support of program objectives.

Conduct and/or ensure Sarepta participation in external meetings with the customer in support of program objectives.

2.1.2.1.2

2.1.2.1.2.1

Technical progress and Milestone achievements.

Schedule progress

Future program plans (e.g. site visits).

Program Risks and Mitigations Plans when identified.

Copies of Draft Study Reports and Final Study Reports when available.

Copies of IACUC and ACURO submission and responses/protocol approvals.

Copies of FDA communications.

Decision: Sarepta shall provide a final summation of all appropriate program study results to USG
[†††].

2.1.2.1.3

2.1.2.1.3.1

Reviews of study/task performance.

Review of study/task records.

Observation of representative study/task related procedures and processes as appropriate.

2.1.2.2

2.1.2.2.1

2.1.2.2.1.1

Oversee resource and personnel deployment so as to ensure timely execution of program tasks in support of program objectives.

Statement of Work

Conduct internal management and functional group meetings to ensure timely program schedule execution, compliance with budgetary constraints, and FAR and DFAR compliance in support of program objectives.

Conduct and/or ensure Sarepta Therapeutics participation in external management meetings with contract service providers to ensure timely program schedule execution, compliance with budgetary constraints, and relevant and FAR and DFAR compliance in support of program objectives.

Conduct and/or ensure Sarepta participation in external meetings with the customer in support of program objectives.

Review progress against the program goals and schedule.

Discuss issues and risks with the potential impact scope, schedule and/or budget.

Reach agreement with the subcontractor on the design of future studies/work.

Contracting with a suitable CRO for manufacture.

Providing necessary [†††].

Manufacture of the [†††].

Release testing.

Statement of Work

Quality Assurance review of the batch record.

Batch record review of the API manufacture.

Review of analytical testing data for both API and the formulation.

Review of the draft batch record.

Review of the completed batch record post production.

Participate in internal management and functional group meetings to ensure timely program schedule execution, compliance with budgetary constraints, and FAR and DFAR compliance in support of program objectives.

Participate in external management meetings with contract service providers to ensure timely program schedule execution, compliance with budgetary constraints, and relevant and FAR and DFAR compliance as appropriate in support of program objectives.

Participate in external meetings with the customer for the purpose of ensuring proper work performance and progress of activities performed in support of program objectives.

Statement of Work

Sarepta shall conduct periodic on-site monitoring of study performance at subcontractor work sites for the purpose of ensuring proper work performance and progress of activities performed in support of program objectives.

      Decision: Final Report accepted

      Decision: [†††]

      Decision: Final Report accepted. [†††]

Statement of Work

CONTRACT DATA REQUIREMENTS LIST

(2 Data Items)

Form Approved

OMB No. 0704-0188

1. DATA ITEM NO.

A001

2. TITLE OF DATA ITEM

Contract Work Break Down Structure

3. SUBTITLE

N/A

17. PRICE

GROUP

16. REMARKS

A 4-Level WBS with costs and schedule per each level. For the lowest task level show the breakdown for labor, material and other indirect costs. BLK 10-13 submit [†††] days after contract award. Government will review and approve at kick off meeting.

Submission of the CWBS to the Defense Cost and Resource Center (DCARC) as mentioned in Paragraph 2 of the DID is not required.

1. DATA ITEM NO.

A002

2. TITLE OF DATA ITEM

Contractor’s Progress, Status and Management Report

3. SUBTITLE

N/A

17. PRICE

GROUP

16. REMARKS

Monthly Technical Presentation via Teleconference to be conducted on a schedule to be set at contract kick off.

Quarterly Status Report due within [†††] calendar days of the end of each Government Fiscal Quarter.

Draft and Final reports of the Tolerability study and the Feasibility study. Draft reports are due within 15 calendar days of the completion of the in-life portion of the studies.

In- Process Review at the midpoint of contract performance.

All reports are subject to review/approval within [†††] calendar days after receipt of the first submittal. Provide changes to draft within 10 calendar days

/s/ [Illegible]

/s/ [Illegible]

  8/20/12

CONTRACT DATA REQUIREMENTS LIST

(2 Data Items)

Form Approved

OMB No. 0704-0188

1. DATA ITEM NO.

A003

2. TITLE OF DATA ITEM

Integrated Master Schedule

3. SUBTITLE

N/A

17. PRICE

GROUP

16. REMARKS

BLK 10-13 submit [†††] days after contract award. Government will review and approve at kick off meeting,. IMS will be statused monthly as of the end of the calendar month and reviewed as part of the monthly technical presentation/teleconference.

1. DATA ITEM NO.

A004

2. TITLE OF DATA ITEM

Contract Funds Status Report

3. SUBTITLE

Project Spend Plan

17. PRICE

GROUP

16. REMARKS

BLKs 10-13: Contractor will provide an updated expenditure forecast reflecting actual negotiated costs over entire period of performance within [†††] calendar days. The spend plan should detail the planned expenditure by month. The Government review/approval will occur at the contract kick off.

The Contract Funds Status Report will be statused [†††] within [†††] calendar days of the end of the contractor’s accounting period.

/s/ [Illegible]

/s/ [Illegible]

  8/20/12

CONTRACT DATA REQUIREMENTS LIST

(2 Data Items)

Form Approved

OMB No. 0704-0188

1. DATA ITEM NO.

A005

2. TITLE OF DATA ITEM

Final Report

3. SUBTITLE

N/A

17. PRICE

GROUP

16. REMARKS

The Final report, if an alternate route of administration is determined to be feasible, will include [†††] that assesses the requirements at a level 3 work breakdown structure (rough order of magnitude schedule and cost) [†††]

Contractor Format Acceptable - Submission is due within [†††] Calendar days of the completion of the IM Feasibility study will be reviewed for completeness by the Government for [†††] Calendar days after the submission and the contractor will have [†††] Calendar days to resubmit the Final Report after resolution of the Government’s comments.

1. DATA ITEM NO.

17. PRICE

GROUP

/s/ [ILLEGIBLE]

/s/ [ILLEGIBLE]

  8/20/12

INSTRUCTIONS FOR COMPLETING DD FORM 1423

(See DoD 5010. 12-M for detailed instructions.)

FOR GOVERNMENT PERSONNEL

Item A. Self-explanatory.

Item B. Self-explanatory.

Item C. Mark (X) appropriate category: TDP - Technical Data Package; TM - Technical Manual; Other - other category of data, such as “Provisioning,” “Configuration Management,” etc.

Item D. Enter name of system/item being acquired that data will support.

Item E. Self-explanatory (to be filled in after contract award).

Item F. Self-explanatory (to be filled in after contract award).

Item G. Signature of preparer of CDRL.

Item H. Date CDRL was prepared.

Item I. Signature of CDRL approval authority.

Item J. Date CDRL was approved.

Item 1. See DoD FAR Supplement Subpart 4.71 for proper numbering.

Item 2. Enter title as it appears on data acquisition document cited in Item 4.

Item 3. Enter subtitle of data item for further definition of data item (optional entry).

Item 4. Enter Data Item Description (DID) number, military specification number, or military standard number listed in DoD 5010.12-L (AMSDL), or one-time DID number, that defines data content and format requirements.

Item 5. Enter reference to tasking in contract that generates requirement for the data item (e.g., Statement of Work paragraph number).

Item 6. Enter technical office responsible for ensuring adequacy of the data item.

Item 7. Specify requirement for inspection/acceptance of the data item by the Government.

Item 8. Specify requirement for approval of a draft before preparation of the final data item.

Item 9. For technical data, specify requirement for contractor to mark the appropriate distribution statement on the data (ref. DoDD 5230.24).

Item 10. Specify number of times data items are to be delivered.

Item 11. Specify as-of date of data item, when applicable.

Item 12. Specify when first submittal is required.

Item 13. Specify when subsequent submittals are required, when applicable.

Item 14. Enter addressees and number of draft/final copies to be delivered to each addressee. Explain reproducible copies in Item 16.

Item 15. Enter total number of draft/final copies to be delivered.

Item 16. Use for additional/clarifying information for Items 1 through 15. Examples are: Tailoring of documents cited in Item 4; Clarification of submittal dates in Items 12 and 13; Explanation of reproducible copies in item 14.; Desired medium for delivery of the data item.

FOR THE CONTRACTOR

Item 17. Specify appropriate price group from one of the following groups of effort in developing estimated prices for each data item listed on the DD Form 1423.

a. Group I. Definition - Data which is not otherwise essential to the contractor’s performance of the primary contracted effort (production, development, testing, and administration) but which is required by DD Form 1423.

Estimated Price - Costs to be included under Group I are those applicable to preparing and assembling the data item in conformance with Government requirements, and the administration and other expenses related to reproducing and delivering such data items to the Government.

b. Group II. Definition - Data which is essential to the performance of the primary contracted effort but the contractor is required to perform additional work to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, or quality of the data item.

Estimated Price - Costs to be included under Group II are those incurred over and above the cost of the essential data item without conforming to Government requirements, and the administrative and other expenses related to reproducing and delivering such data item to the Government.

c. Group III. Definition - Data which the contractor must develop for his internal use in performance of the primary contracted effort and does not require any substantial change to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, and quality of the data item.

Estimated Price - Costs to be included under Group III are the administrative and other expenses related to reproducing and delivering such data item to the Government.

d. Group IV. Definition - Data which is developed by the contractor as part of his normal operating procedures and his effort in supplying these data to the Government is minimal.

Estimated Price – Group IV items should normally be shown on the DD Form 1423 at no cost.

Item 18. For each data item, enter an amount equal to that portion of the total price which is estimated to be attributable to the production or development for the Government of that item of data. These estimated data prices shall be developed only from those costs which will be incurred as a direct result of the requirement to supply the data, over and above those costs which would otherwise be incurred in performance of the contract if no data were required. The estimated data prices shall not include any amount for rights in data. The Government’s right to use the data shall be governed by the pertinent provisions of the contract.