W81XWH-17-R-0040_Solicitation_SF33.pdf

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99 - 106 X H 107 - 112 toloria.s.duvall.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 112

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

TOLORIA S DUVALL 301-619-2836

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 2 3 - 4

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

5 - 14

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

17 - 18

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 19 - 20 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 21 - 26 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

27 - 78

PART II - CONTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

07 Jul 2017

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH-17-R-0040

Section A - Solicitation/Contract Form

GENERAL INFORMATION

Project Title: Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate- Severe Traumatic Brain Injury (POI TBI)

This is a Research & Development (R&D) requirement.

The Government anticipates that any resulting award from this Request for Proposal (RFP) will be a Firm-Fixed- Price (FFP) contract.

The base period of performance(POP) will be eighteen (18) months.

North American Industry Classification System (NAICS) Code: 541712—Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Product Service Code: AJ93—R&D-General Science/Technology: Other (Advanced Development)

Points of Contact (POCs): The primary point of contact (POC) for this solicitation is Toloria DuVall, Contract Specialist, toloria.s.duvall.civ@mail.mil. The alternate POC for this solicitation is Monica Ven Douern, Procurement Technician, monica.c.vendouern.civ@mail.mil. All inquiries regarding this requirement must be submitted via electronic mail (e-mail) to the Contract Specialist. Please carbon copy (cc) the Procurement Technician on all correspondence.

Solicitation Questions: Questions concerning this solicitation shall be submitted in writing to the primary POC (cc the alternate POC) via e-mail no later than 14 July 2017 at 4:00 PM Eastern Time. The e-mail must have a subject title of “W81XWH-17-R-0040 Solicitation Questions”. Any questions submitted after this date and time will not be accepted or answered. Answers to Contractor submitted questions will be provided to all Offerors through a solicitation amendment. Telephone inquiries will NOT be accepted at any time.

Proposal Submission: Due to the difficulties in receipt of mail through normal postal services, proposals shall only be electronically submitted to the primary POC (cc the alternate POC) via e-mail. The e-mail must have a subject title of “W81XWH-17-R-0040 Proposal Submission”. The Offeror is responsible for verifying receipt by the POC. One electronic copy shall be submitted for each proposal volume. Each proposal volume should be a separate attachment.

Proposal Due Date: No later than 07 August 2017 at 4:00 PM Eastern Time. Any proposals received after this date and time may not be considered for evaluation. Offerors’ proposals shall remain open for a minimum of 120 days from the date of submission.

Alternate Proposals: Only one proposal from each Offeror will be evaluated by the Government.

The Government anticipates that this solicitation will result in up to (but not greater than) five (5) contract awards.

This invitation to submit a proposal does not assure that a contract will be awarded.

The Offeror’s proposal will be incorporated by reference into a resulting contract. The Offeror’s Statement of Work (SOW) will be incorporated in full text into any resulting contract.

(End of General Information)

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job POI-TBI - Labor

FFP

Labor for POI-TBI device development. The Contractor shall develop a prototype Point of Injury (POI) Device to Measure and Monitor Physiological Parameters Relevant to Moderate-Severe Traumatic Brain Injury (TBI) in accordance with the Statement of Objectives (SOO).

FOB: Destination

NET AMT

0002 1 Job POI-TBI - ODCs

COST

Other Direct Costs for POI-TBI device development. The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's, to include Travel, in accordance with the Government's SOO and the Contractor's SOW.

The Government shall not pay costs in excess of the amounts identified in the Offeror's proposal.

ESTIMATED COST NTE

0003 1 Job Exhibit A, Data Item No. A001

FFP

Contract Data Requirements List (CDRL), Exhibit A, Data Item No. A001, Scientific and Technical Reports.

0004 1 Job Contractor Manpower Reporting (CMR)

FFP

Contractor shall input information in accordance with USAMRAA Instruction "Contractor Manpower Reporting (CMR)" in Section C. If the Offeror proposes CMR as "Not Separately Priced (NSP)" this CLIN will be removed (the contract writing system does not allow NSP or $0.00 CLINs); however the Contractor will still be required to complete and verify CMR.

Section C - Descriptions and Specifications

USAMRAA INSTRUCTIONS

Contractor Manpower Reporting (CMR) (June 2015)(USAMRAA Instruction)

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the POI TBI Device Development via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: https://cmra.army.mil/Login.aspx. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the applicable help desk at:

https://cmra.army.mil/Login.aspx.

(End of Instruction)

Contractor Identification (June 2015)(USAMRAA Instruction)

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company.

The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

STATEMENT OF OBJECTIVES (SOO)

Statement of Objectives

Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate-Severe Traumatic Brain Injury (POI TBI)

1.0 Background and Overview

Over 350,000 Service Members (SMs) have sustained Traumatic Brain Injuries (TBIs) over the last 16 years. The US Army Medical Research and Materiel Command (USAMRMC) Joint Program Committee 6 (JPC-6) and US Army Medical Materiel Agency (USAMMA) develop novel strategies to measure and monitor brain physiological parameters in moderate and severe TBI casualties in the far forward environment and in Prolonged Field Care scenarios. The accurate and rapid triage and treatment of life-threatening neurotrauma is an essential first step for the appropriate care of injured SMs by first responders.

Combat Related Traumatic Brain Injury (CRTBI) is a significant and common injury of military conflict. CRTBI is often concomitant with a multiple casualty scenario, further complicating triage and treatment decisions. Rapid measurement of TBI-related physiological parameters in multiple casualties, particularly moderate and severe closed head injuries, is essential to reducing morbidity and mortality in this critically injured population.

The ability to measure, monitor, record, and transmit critical physiological parameters in the minutes to hours following injury is vital to improve neurotrauma casualty care and to create a system of seamless care from point of injury (POI) to higher echelons of care, including during transportation. Some possible parameters to measure that are relevant to TBI include, but are not limited to: intracranial pressure, cerebral blood flow, cerebral oxygenation, heart rate variability, electrocortical activity, extra-vascular blood volume, and blood pressure.

The Government intends to award an initial contract to deliver prototype devices that are capable of meeting the Government objectives stated below. The Government anticipates the initial solicitation will result in multiple awards for the technology refinement (if needed) and delivery of these prototypes for assessment. After device assessment of the delivered prototypes, the Government intends to down select, potentially to a single product, and award a second contract for pilot and pivotal studies to finalize and prepare for US Food and Drug Administration (FDA) submission and production.

2.0 Scope of Work

2.1. This contract is for development of prototype devices for the Government, with a goal to ultimately fill a USAMRMC requirement for a FDA-market authorization to be used at the POI to aid first responders in making triage and initial treatment decisions for non-penetrating moderate and severe TBI.

2.2. This is a non-personal Research and Development contract to modify existing products/technology and deliver prototype articles for assessment. The contractor shall deliver two sets of prototypes and related documentation to the Government as set forth below.

2.3. The Contractor shall deliver its initial prototype to the USAMMA Contracting Officer’s Representative (COR) within 45 calendar days after contract award. After delivery, the Contractor will be contacted by the USAMMA COR within 2 weeks to set up an in-person meeting for prototype demonstration that will take place no later than 45 calendar days after prototype delivery.

2.4. The Contractor(s) shall subsequently refine its prototype device, and within 17 months of contract award, deliver the refined prototype that satisfies program requirements to the USAMMA COR.

2.5. The Contractor(s) shall develop the device in accordance with (IAW) all applicable State laws, Federal laws, DoD regulations, and US Army regulations.

2.6. The Contractor shall be the FDA regulatory sponsor in accordance with Code of Federal Regulations Title 21 Food and Drugs.

2.7. The Contractor shall include the USAMMA COR or his/her designee in all meetings both formal and informal with the FDA. The Contractor shall provide copies of meeting packages for both formal and informal meetings with the FDA to the USAMMA COR at least 10 business days prior to the FDA meetings. The Government will review and provide recommendations on these documents within 5 business days of receiving them. The contractor shall provide copies of all communications, to include meeting minutes, emails, and letters, to and from the FDA within 5 business days after receipt from the FDA. If submissions have occurred prior to contract award, the contractor shall provide copies of any submissions, to date, with the initial prototype.

2.8. The Contractor shall provide a representative to participate as a member of the working group (WG) within 10 business days of award. The representative shall participate in meetings via teleconference up to twice a month as requested by the Government and provide status updates on cost, schedule, and performance of the contract. The Contractor WG member will be excused when government-only or other contractor proprietary materiel is discussed. The Contractor shall support Government program reviews, which occur annually and at key program decision points

2.9. The Government does not intend to provide equipment or facilities. The Government will not provide the Contractor with Government network access, building access badges, or common access cards during the duration of the contract.

2.10. The Government will provide subject matter expertise, assisting in the development of clinical protocol;

auditing the clinical and manufacturing sites, IAW all applicable State laws, Federal laws, DoD regulations, and US Army regulations.

3.0 Statement of Objectives (Essential Characteristics)

The Government’s objective is to rapidly field an FDA-market authorized medical device that provides physiological data to aid first responders (i.e., field medics) in making triage and treatment decisions for TBI patients. To meet this objective, the device must function on both conscious and unconscious casualties and shall be small, lightweight, rugged, have the ability to be used multiple times, and therefore be able to function in battlefield environments. It is expected to be able to withstand high temperatures, low temperatures, and function at high altitudes during both operation and storage, operate in rainy, humid, and dusty environments, and operate after drop and transportation situations. The device shall provide an output of visual readings that are easy for first responders to understand and use, require minimal training or maintenance, and operate for extended periods with minimal power consumption. The device will provide medics with data that will help them to determine casualty evacuation priority or care required to prevent secondary injury. The successful device shall minimize number and cost of required consumables. A prototype device and consumables that do not require special handling are highly preferable. Special handling includes, but is not limited to, the need for temperature or humidity controlled storage areas, the need for special temperature controls, the need for maintaining unit under various forms of continuous operation, the need for segregated storage facilities dictated by the nature of the contents, or any other factors requiring more than straight forward receipt, storage, simple cyclic inspection, and issue of a standard commodity, and the need for special handling equipment or floor space for any item. The Contractor shall include any publications, scientific data, and white papers that demonstrate proof of concept, device sensitivity, and device specificity of the proposed technology. The device shall be at technology readiness level 6 or greater for the purpose of reducing risk and shortening the time between program start and product fielding. (See Appendix E:

Biomedical Technology Readiness Levels (TRLs) http://www.acqnotes.com/Attachments/Technology%20Readiness%20Assessment%20Deskbook.pdf.) The final prototype(s) will be required to be demonstrated to the USAMMA COR and Government representatives by the end of the period of performance (POP).

The Government anticipates that future combat operations may require medical personnel to provide prolonged medical care in the pre-hospital environment for up to 72 hours prior to evacuation. To reduce the morbidity and mortality associated with moderate and severe brain injuries incurred on the battlefield, the objective device shall support medical personnel in the pre-hospital management of patients for extended periods when casualty evacuation is delayed or unavailable.

The Government realizes that the ideal goals stated below may not be obtainable within the period of performance of the contract; however, preference for potential future work will be given to Contractors who are closest to achieving these goals.

Upon completion of the contract, the ideal device:

will be a standalone device (no wireless capabilities needed for use);

<0.5 pounds;

have a volume of less than 11in3;

operate in temperatures from -24oF to 120oF;

be operational after being stored in temperatures from -27oF to 160oF;

operate in “Constant High Humidity” environments as described in MIL-STD-810G;

operate in “Rain and Blowing Rain” environments as described in MIL-STD-810G;

operate in “Blowing Dust” environments as described in MIL-STD-810G;

operates after a “Functional Shock” of 48in. as described in MIL-STD-810G;

operates after “General Vibration” and “Loose Cargo Transportation” as described in MIL-STD-810G;

display is readable in low light conditions, bright sunlight conditions, and is compatible with night vision goggles;

does not emit a radio frequency signature;

can conduct a minimum of 150 assessments on one battery life;

operate at altitudes ranging from 0ft to10,000ft;

acquire measurements in ≤1 minute;

function on both conscious and unconscious SMs;

meets Joint Enroute Care Equipment Test Standard (JECETS) for flight;

require calibration at most once a year;

calibration does not require any specialized equipment;

have the ability to be calibrated by a DoD Biomedical Equipment Specialist in the field;

be maintainable in the field by a DoD Biomedical Equipment Specialist without internet connection;

have a sensitivity and specificity of at least 95%; and require less than 3 hours of clinical training to master the use of the device.

Priority of Government objectives for a successful program outcome (which may be beyond the scope of this immediate contract) is for a device that:

1. Is FDA market authorized for use at the POI to measure and monitor physiological parameters for at least 72 hours related to non-penetrating moderate and severe TBI. Medical personnel will use this device as an aid in triage and treatment decisions of non-penetrating brain injuries.

2. Provides physiologic data on both conscious and unconscious casualties.

3. Minimizes the time to deliver the FDA market authorized device. The Government will consider a phased approach that initially provides some lesser FDA-market authorized capability that can be expanded with future development.

4. Minimizes the size and weight of the device, including all required consumables.

5. Maximizes the battery life of the device and the speed at which measurements are acquired.

6. Minimizes required operator/user training.

7. Minimizes life-cycle storage, operating, and maintenance costs, to include the cost of health provider and maintainer manpower.

4.0 Delivery Date

The period of performance shall be up to 18 months from contract award.

5.0 Contract Deliverables

5.1 The Contractor shall deliver the following:

5.1.1. Within 45 calendar days after award, deliver one (1) initial prototype (Deliverable 1) to the USAMMA COR including consumables, patient simulation devices, if needed (Contractor furnished for the duration of the demonstration only such as specialized mannequins), manuals (operator and maintenance in both paper and electronic versions), any prior submissions to the FDA, and training materials as applicable. Consumables, if applicable, shall be sufficient for at least 15 patient uses of the device.

5.1.2. After delivery, the Contractor will be contacted by the USAMMA COR within 2 weeks to set up an in person meeting for a prototype demonstration (Deliverable 2) with the USAMMA COR and other Government Representatives at Fort Detrick, Maryland to take place no later than 45 calendar days after prototype delivery. The demonstration will include a hands on demonstration explaining the concept of the TBI parameter(s) measured, the use of, and maintenance of the prototype. This hands on demonstration is anticipated to be less than 3 hours.

5.1.3. Within 17 calendar months of contract award, each Contractor shall deliver three (3) units of their refined prototype (Deliverable 3) including consumables, patient simulation devices, if needed (Contractor furnished for the duration of the demonstration only such as specialized mannequins), manuals (operator and maintenance in both paper and electronic versions), and training materials as applicable. Consumables, if applicable, shall be sufficient for at least 15 patient uses of the device.

5.1.4. By the end of the contract, the Contractor shall provide a hands on demonstration (Deliverable 4) on the use of and maintenance of the final prototype in an in-person meeting with the USAMMA COR and other Government Representatives that will view the prototype at Fort Detrick, Maryland. This hands on demonstration is anticipated to be less than 3 hours. The Contractor will be contacted by the USAMMA COR after final prototype delivery to schedule the meeting. The date of the demonstration should be finalized NLT fifteen (15) calendar days after delivery of the final prototype and the demonstration shall be held NLT than the last day of the contract’s period of performance.

5.1.5. No Later Than 10 calendar days prior to the expiration of the contract, the Contractor shall submit a gap analysis with cost report (Deliverable 5) to the USAMMA COR that includes, but is not limited to the timeline of regulatory strategies for FDA communication leading to the submission for market authorization of a device with the indication to be used at the POI to measure and monitor physiological parameters related to moderate/severe TBI, a manufacturing capability plan, remaining estimated costs to achieve FDA market authorization and an estimated 5 year life cycle cost for the device and consumables. The report will also include the commercial viability of the device. If the device has already achieved FDA market authorization for the previously stated indication, please provide the manufacturing capability plan, and a 5 year life cycle cost for the device and consumables.

5.1.6. Prepare a Project Management Plan (including organization chart) (Deliverable 6)that includes, but is not limited to, an Integrated Master Schedule (IMS) and a Work Breakdown Structure (WBS) that encompasses the entire scope of the contract based on this Government provided SOO. The IMS documents the critical path, major milestones, tasks/activities, duration, lead/lag/slack time and schedule relationships, and is directly traceable to the SOO. The PMP shall be updated at least quarterly to track progress or at the Government’s request.

5.1.7. Prepare and implement a written Quality Assurance Plan (Deliverable 7) to ensure that all activities of the project are managed in a sound, reasonable way in conformance to the Government's requirements; and that all deliverables produced are acceptable prior to delivery to the Government. Under this Quality Assurance Plan, provide for the Government or its designee to audit the Contractor and/or its Subcontractors for quality assurance purposes. Provide evidence of the quality agreement. The Quality Assurance Plan shall be updated at least quarterly or at the Government’s request.

5.1.8. Develop a FDA communication plan (Deliverable 8) including but not limited to meetings, communications, submission packets, inspections and enforcements. The plan shall describe how the Contactor will inform, document, and include the Government for all FDA interactions (formal and informal) and audits when possible.

The Contractor shall act as the FDA sponsor for this product, in accordance with 21 CFR 50.3 (Code of Federal Regulations). The FDA communication plan shall be updated annually or at the Government’s request.

5.1.9. Describe the regulatory strategy (pathway) (Deliverable 9) for FDA regulatory market authorization and any possible post-marketing commitments that include, but are not limited to, the product nomenclature and classification; device description; intended use/indication for use; regulatory pathway; current development/regulatory status of the product; previous FDA interactions or submissions; potential predicate devices (if applicable); data collection plan; and life cycle considerations. Update as needed based on FDA feedback or Government request.

5.1.10. Provide a representative (Deliverable 10) to participate as a member of the Government Working Group (WG) within 10 calendar days of contract award. Representative shall participate in WG meetings via teleconference up to twice a month as requested by the Government and provide status updates on cost, schedule, and performance of the contract. The Contractor WG member will be excused when government-only materiel is discussed.

5.1.11. Provide monthly Contractor's Progress, Status, and Management Reports (Deliverable 11) and an updated schedule that describes progress made within the period and inform the Government of existing or potential issues and problem areas and risk mitigation plans. These reports shall include an updated IMS that shows the percent complete of each scheduled task item. Percent complete is defined as the cumulative amount of work actually performed through the end of the reporting month expressed as a percentage of the total amount of work to be performed. As part of the IMS update, the Contractor shall also reforecast all outstanding task activities.

5.1.12. Provide quarterly Contractor's Progress, Status, and Management Reports (Deliverable 12) and an updated schedule that describes progress made within the period and inform the Government of existing or potential issues and problem areas and risk mitigation plans. These reports shall include an updated IMS that shows the percent complete of each scheduled task item. Percent complete is defined as the cumulative amount of work actually performed through the end of the reporting month expressed as a percentage of the total amount of work to be performed. As part of the IMS update, the Contractor shall also reforecast all outstanding task activities.

5.1.13. The Contactor shall report any significant positive or negative deviation to the schedule or scope of a task (Deliverable 13) immediately to the Government, and the deviation shall be explained within 5 business days of issue being identified and documented by the Contractor in its monthly and quarterly reports.

5.1.14. The Contractor shall submit a manufacturing plan (Deliverable 14) that should include, but is not limited to the personnel planning, facility planning, master phasing schedule, master production schedules, and lead time evaluation in accordance with Good Manufacturing Practices (GMP).

5.1.15. The Contractor shall provide a Spend Plan (Deliverable 15) which details how they expect to incur and invoice for costs against the contract. The Spend Plan shall detail costs to be incurred monthly by fiscal year (1 October – 30 September) and by contract year, starting with the first month of the contract period of performance.

The Spend Plan total shall match with the total price proposed for the entire contract effort. The Spend Plan shall be provided after contract award. The Contractor shall report actual progress and Spend Plan updates in the Monthly Progress Report.

5.1.16. The Contractor shall provide verification of Contractor Manpower Reporting (CMR) submission (Deliverable 16) to the COR and the Contract Specialist via e-mail.

5.1.17. The Contractor shall provide the COR with System Engineering documents (Deliverable 17, Exhibit A, CDRL A001) including, but not limited to a complete technical data packet (TDP) upon request by the Government within seven (7) business days. The Contractor shall prepare and maintain currency of a TDP that includes all necessary documentation and technical data and reports collected and prepared during the development effort funded by the Government. The TDP shall include all necessary documentation and data for the Government, or its designee, to continue the development or production of the product, including but not limited to the design history file, device master record, and device history record. The Contractor shall assist in the technical transfer as directed by the Government. The Contractor shall provide copies of TDP content as requested by Government and at contract expiration.

Table 1. List of Deliverables

Item Ref Title Distribute To

Initial Subsequent Comments

Deliverable 1 SOO 5.1.1

Initial Prototype Delivery

COR NLT 45

calendar days after contract award.

N/A To include consumables, simulation devices, manuals, training materials, & previous FDA submissions as applicable.

To

Initial Subsequent Comments

Deliverable 2 SOO 5.1.2

Initial Prototype Demonstration

COR NLT 45

calendar days after prototype delivery.

N/A At Fort Detrick, MD

Deliverable 3 SOO 5.1.3

Refined Prototype Delivery

COR NLT 17

calendar months after contract award.

N/A To include consumables, simulation devices, manuals, & training materials as applicable.

Deliverable 4 SOO 5.1.4

Refined Hands on Prototype Demonstration

COR NLT contract expiration.

N/A At Fort Detrick, MD

Deliverable 5 SOO 5.1.5

Gap Analysis & Cost Report

COR NLT 10

calendar days prior to contract expiration.

N/A To include future FDA regulatory strategy, manufacturing plan, regulatory costs, 5 year life cycle cost.

Deliverable 6 SOO 5.1.6

Project Management Plan (includes IMS and

WBS)

COR

(Subsequent only, initial is submitted with proposal).

With proposal submission.

Quarterly, as needed, and within 15 calendar days of Government request.

To include project scope, activities, schedule, & risks.

Deliverable 7 SOO 5.1.7

Quality Assurance Plan

COR NLT 30

calendar days after contract award.

Quarterly, as needed, and within 15 calendar days of Government request.

None.

Deliverable 8 SOO 5.1.8

FDA

Communication Plan

COR

(Subsequent only, initial is submitted with proposal).

With proposal submission.

Annually and within 15 calendar days of Government request.

Must include Government in all

FDA

communication, both formal and informal.

Deliverable 9 SOO 5.1.9

Regulatory Strategy

COR

(Subsequent only, initial is submitted with proposal).

With proposal submission.

Updated within 15 calendar days of Government request and when needed based on FDA communication.

Regulatory pathway.

Initial Subsequent Comments

Deliverable 10 SOO 5.1.10

WG

Representative

COR WG

Representative identified and assigned NLT 10 calendar days after contract award.

Updated if representative changes.

Representative will participate in WG meetings via teleconference up to twice a month.

Deliverable 11 SOO 5.1.11

Monthly Progress Reports

COR NLT the 10th calendar day of the month following contract award.

On the 10th day of every month during the period of performance.

To include updated Integrated Master Schedule that describes progress made within the reporting period and informs the Government of existing or potential issues and problem areas.

Deliverable 12 SOO 5.1.12

Quarterly Progress Reports

COR NLT the 15th calendar day of the 3rd month following contract award.

On the 15th day of every third month during the period of performance.

To include updated Integrated Master Schedule that describes progress made within the reporting period and informs the Government of existing or potential issues and problem areas.

Deliverable 13 SOO 5.1.13

Issue Summary Report

COR, Contract Specialist

As required, within 5 business days of issue identification.

As required, within 5 business days of issue identification.

Details the event that will cause more than a one (1) month delay in schedule or an increase in costs/price.

Deliverable 14 SOO 5.1.14

Manufacturing Plan

COR NLT 6 calendar months after contract award.

N/A None.

Deliverable 15 SOO 5.1.15

Spend Plan COR, Contract Specialist

NLT 10

calendar days after contract award.

Monthly updates with the Monthly Progress Report.

None.

Initial Subsequent Comments

Deliverable 16 SOO 5.1.16

Verification of Contractor Manpower Reporting (CMR) Submission

COR, Contract Specialist

NLT 31

October.

Annually, NLT 31 October.

None.

Deliverable 17 (Exhibit A, CDRL A001)

SOO

5.1.17

Technical Data Package (TDP)

COR Within seven (7) business days of Government’s request.

Within seven (7) business days of Government’s request and at contract expiration.

To include, but not limited to the design history file, device master record, and device history record.

5.2 Contract Data Requirements List

Table 2. Contract Data Requirements List (CDRL) Contract Line Item Number (CLIN)

Contract Data Requirements List

(CDRL)

SOO Reference Data Item Description (DID)

DID Number

0003 A001 5.1.17 Formatting directive for the submission of publications, Scientific reports, white papers, and data.

DI-MISC-80711

5.3 Deliverables Schedules Abbreviations

The following abbreviations are used in the deliverable schedules.

Table 3. Contracting Term Abbreviations Abbreviation Definition COR Contracting Officer’s Representative DA Days after DACA Days after contract award DAEOM Days after end of month DAOP Days after option award MACA Months after contract award MAOA Months after option award NLT No Later Than SOO Ref Statement of Objectives Reference (paragraph number)

5.4 Delivery Address

All deliverables shall be delivered to the USAMMA COR designated in the COR appointment letter.

5.5 Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint, MS Project, or MS Access format), unless otherwise specified by the USAMMA COR. Electronic submission shall be made via email, unless otherwise agreed to by the USAMMA COR. The contractor shall make sure of commercial best practices in the packing and shipment of packages.

6.0 Travel & Other Direct Costs (ODCs)

ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), fee will not be paid on ODCs or travel.

Contractor will be authorized travel expenses consistent with the substantive provision of the Joint Travel Regulation (JTR) and the limitation of funds specified in the contract. All travel requires Government prior approval/authorization by the USAMMA COR.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit travel requests with estimated costs to the COR NLT fifteen (15) calendar days prior to travel. Travel costs shall be incurred and billed in accordance with FAR Part 31 for up to 3 Contractor employees for each prototype demonstration event held at Fort Detrick, Maryland. Costs for these expenses will be reviewed, certified and approved by the USAMMA COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR Part 31.

Table 4. Example of Travel Information From To Round Trip

(Y/N) # of Trips # of People # of Days

XXX Ft. Detrick, MD Y 2 Up to 3 1

(End of SOO)

STATEMENT OF WORK (SOW)

TO BE PROVIDED BY THE OFFEROR.

The SOW will be incorporated into the contract in full text.

(End of SOW)

Section D - Packaging and Marking

DELIVERABLES

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with the instructions contained herein. At a minimum, all deliverables shall be marked with the contract number and Contractor name.

(End of Deliverables)

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-7 Inspection Of Research And Development Fixed Price AUG 1996 52.246-16 Responsibility For Supplies APR 1984 252.204-0001 Line Item Specific: Single Funding SEP 2009

CLAUSES INCORPORATED BY FULL TEXT

252.204-0003 LINE ITEM SPECIFIC: CONTRACTING OFFICER SPECIFIED ACRN ORDER. (SEP 2009)

The payment office shall make payment within the line item in the sequence ACRN order specified below, exhausting all funds in the previous ACRN before paying from the next ACRN.

Line Item ACRN Order

0001 AA, AB, & AC.

(End of clause)

Section F - Deliveries or Performance

REPORTS, MANUSCRIPTS AND PUBLIC RELEASES (June 2015) (USAMRAA)

a. Contractors are encouraged to publish results of research supported by the US Army Medical Research and Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel.

b. Manuscripts intended for publication in any media shall be submitted to the Contracting Officer and Contracting Officer's Representative (COR), simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the Contracting Officer and COR, even though publication may be subsequent to the expiration of the contract.

c. The Contractor shall notify the Contracting Officer of planned news releases, planned publicity, advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice in order to adequately respond to inquiries.

d. Manuscripts, reports, public releases and abstracts, which appear in professional journals, media and programs, shall include the following statements:

(1) "This work is supported by the US Army Medical Research and Materiel Command under Contract No. To Be Determined"

(2) "The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation."

(3) As applicable, if the research involves the use of animals, the Contractor must include the following statement:

"In conducting research using animals, the investigator(s) adhered to the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and the principles set forth in the current version of the Guide for Care and Use of Laboratory Animals, National Research Council."

(4) As applicable, if the research involves human use, the Contractor must include the following statement: "In the conduct of research where humans are the subjects, the investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects)."

(5) As applicable, if the research involves the use of recombinant DNA, the Contractor must include the following statement: "In conducting work involving the use of recombinant DNA the investigator(s) adhered to the current version of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules."

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 POP 25-SEP-2017 TO

24-MAR-2019

N/A BRIAN DACANAY

BRIAN DACANAY

693 NEIMAN STREET, 3W-221

FREDERICK MD 21702

W25MWY

0002 POP 25-SEP-2017 TO

24-MAR-2019

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 25-SEP-2017 TO

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 25-SEP-2017 TO

N/A (SAME AS PREVIOUS LOCATION)

52.242-15 Stop-Work Order AUG 1989 52.242-17 Government Delay Of Work APR 1984 52.247-34 F.O.B. Destination NOV 1991

Section G - Contract Administration Data

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

Invoice 2-in-1 (Services only)

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

Inspection location: Destination Acceptance location: Destination

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF Pay Official DoDAAC HQ0490 Issue By DoDAAC W81XWH Admin DoDAAC W81XWH Inspect By DoDAAC W25MWY Ship To Code W25MWY Ship From Code N/A Mark For Code N/A Service Approver (DoDAAC) W25MWY Service Acceptor (DoDAAC) W25MWY Accept at Other DoDAAC N/A LPO DoDAAC N/A DCAA Auditor DoDAAC N/A Other DoDAAC(s) N/A

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

brian.i.dacanay.civ@mail.mil (AlternateCOR@mail.mil) toloria.s.duvall.civ@mail.mil

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

Not applicable.

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

Section H - Special Contract Requirements

INVESTIGATING AND REPORTING POSSIBLE SCIENTIFIC MISCONDUCT (June 2015) (USAMRAA)

a. "Misconduct" or "Misconduct in Science" is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

b. Contractors shall foster a research environment that prevents misconduct in all research and that deals forthrightly with possible misconduct associated with research for which U.S. Army Medical Research and Materiel Command funds have been provided or requested.

c. The contractor agrees to:

(1) Establish and keep current an administrative process to review, investigate, and report allegations of misconduct in science in connection with research conducted by the contractor;

(2) Comply with its own administrative process;

(3) Inform its scientific and administrative staff of the policies and procedures and the importance of compliance with those policies and procedures;

(4) Take immediate and appropriate action as soon as misconduct on the part of employees or persons within the organization's control is suspected or alleged; and

(5) Report to the Administrative Contracting Officer (ACO) a decision to initiate an investigation into possible scientific misconduct.

d. The contractor is responsible for notifying the ACO of appropriate action taken if at any stage of an inquiry or investigation any of the following conditions exist:

(1) An immediate health hazard is involved;

(2) There is an immediate need to protect Federal funds or equipment;

(3) A probability exists that the alleged incident will be reported publicly; or

(4) There is a reasonable indication of possible criminal violation.

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (OCOI) (June 2015)

(USAMRAA)

a. It is recognized by the Government that the effort performed by the contractor under this contract is of a nature that it creates a potential organizational conflict of interest as is contemplated under the Federal Acquisition Regulation Subpart 9.5.

b. An organizational conflict of interest may result when factors create an actual or potential conflict of interest on a contract, or when the nature of work of the work to be performed on the contract creates an actual or potential conflict of interest on a future acquisition. Some restrictions on future activities of the contractor may be required.

c. In the performance of this contract, the contractor may have access to data which is procurement sensitive or is proprietary to other companies, Government consultants or advisors, or the Government. The contractor agrees that he will not utilize such procurement sensitive or proprietary data in performance of future competitive contracts, for studies in the same field, procured either through sealed bids or competitive negotiations unless authorized by the contracting officer.. The contractor further agrees not to act as a subcontractor or consultant to any other prime contractor or subcontractor seeking to utilize such data.

d. The contractor will include the provisions of paragraphs a and b in every first tier subcontract for performance of any portion of this requirement.

PROHIBITION OF HUMAN RESEARCH (June 2015) (USAMRAA)

PROHIBITION – READ FURTHER FOR DETAILS

Research under this award involving the use of human subjects, to include the use of human anatomical substances or identifiable private information (human data), shall not begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research may proceed. Written approval to begin research will be issued from the USAMRMC ORP, under separate notification to the contractor. Written approval from the USAMRMC ORP is also required for any subcontractor that will use funds from this award to conduct research involving human subjects.

Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the USAMRMC ORP. Complete study records shall be maintained for each human research study and shall be made available for review by representatives of the USAMRMC.