W81XWH-17-R-0040-0001_Solicitation-Amendment_SF30.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The subject solicitation is amended for the follow ing purpose:

1) Provide Vendor questions and the Government's responses (Solicitation Attachment 5 – Questions & Answ ers).

2) Revise the Statement of Objectives (SOO) in accordance w ith the Government's answ ers to Vendor questions.

3) Delete clauses 52.209-1 and 52.209-4 in accordance w ith the Government’s answ ers to Vendor questions.

4) Revise Attachment 3 'Cost/Pricing Template (.xls)' in accordance w ith the Government's answ ers to Vendor questions.

The due date/time for proposals has not been extended. All other terms and conditions remain unchanged. See 'Summary of Changes' for details.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 24

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 21-Jul-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH-17-R-0040

X 9B. DATED (SEE ITEM 11)

07-Jul-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

21-Jul-2017

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH-17-R-0040

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

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 the POP start date. 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 the POP start date, 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 the POP start date, 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 currently 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 device is required to function on both conscious and unconscious SMs. The device shall be compliant with the FDA Quality System Regulation (QSR) and International Organization for Standardization (ISO) 13485.

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 (approximately the size of a smartphone) stored or expanded for use;

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 (i.e. samples read) on one battery life;

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

acquire measurements in ≤1 minute;

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 (POP) shall be up to 18 months from the POP start date.

5.0 Contract Deliverables

NOTE: For this requirement “deliver” means that the USAMMA COR is in possession of the deliverable.

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 the POP start date, 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 each device (total of 45 consumables for this deliverable).

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 and implement a FDA communication plan (Deliverable 8) that includes but is 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. 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 the POP start date, the contractor shall provide copies of any submissions, to date, with the initial prototype.

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 the POP start date. 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 the POP start date. 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 the POP start date.

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

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 the POP start date.

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

To

Initial Subsequent Comments

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 the POP start date.

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

None.

Initial Subsequent Comments

Deliverable 8 SOO 5.1.8

FDA

Communication (Plan & Exchanges)

FDA

Communicatio n Plan:

COR

(Subsequent only, initial plan is submitted with proposal).

FDA

Exchanges:

COR

(Initial and subsequent).

FDA

Communication Plan:

With proposal submission.

FDA

Exchanges:

Copies of meeting packages at least 10 business days prior to the FDA meetings.

Copies of all

FDA

communications within 5 business days after receipt from the FDA.

FDA

Communication Plan:

Annually and within 15 calendar days of Government request.

FDA

Exchanges:

Copies of meeting packages at least 10 business days prior to the FDA meetings.

Copies of all

FDA

communications within 5 business days after receipt from the FDA.

Must include Government in all

FDA

communication, both formal and informal.

The Government will review meeting packages and provide recommendations on these documents within 5 business days of receiving them.

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.

Deliverable 10 SOO 5.1.10

WG

Representative

COR WG

Representative identified and assigned NLT 10 calendar days after the POP start date.

Updated if representative changes.

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

Initial Subsequent Comments

Deliverable 11 SOO 5.1.11

Monthly Progress Reports

COR NLT the 10th calendar day of the month following the POP start date.

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 the POP start date.

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 the POP start date.

N/A None.

Deliverable 15 SOO 5.1.15

Spend Plan COR, Contract Specialist

NLT 10

calendar days after the POP start date.

Monthly updates with the Monthly Progress Report.

None.

Deliverable 16 SOO 5.1.16

Verification of Contractor Manpower Reporting (CMR) Submission

COR, Contract Specialist

NLT 31

October.

Annually, NLT 31 October.

None.

Initial Subsequent Comments

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)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

USAMRAA INSTRUCTIONS

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.

(End of Instruction)

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. Research records shall be stored in a confidential manner so as to protect the confidentiality of subject information.

The contractor is required to adhere to the following reporting requirements:

Submission of major modifications to the protocol, continuing review documentation, and the final report are required as outlined in the USAMRMC ORP approval memorandum.

Unanticipated problems involving risks to subjects or others, clinical holds (voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, shall be promptly reported to the USAMRMC ORP and the USAMRAA Contracting Office.

The knowledge of any pending compliance inspection/visits by the FDA, ORP, or other government agency concerning this clinical investigation or research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies including legal or medical actions, and any instances of serious or continuing non-compliance with regulatory requirements that relate to this clinical investigation or research, shall be reported immediately to the USAMRMC ORP and the USAMRAA Contracting Office. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award.

Prohibition of Use of Human Subjects (NOVEMBER 2015)

PROHIBITION - READ FURTHER FOR DETAILS

Research under this award involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research may proceed. The USAMRMC ORP will issue written approval to begin research under separate notification to you. Written approval to proceed from the USAMRMC ORP is also required for any subrecipient that will use funds from this award to conduct research involving human subjects.

The USAMRMC ORP conducts site visits as part of its responsibility for compliance oversight. Accurate and complete study records must be maintained and made available to representatives of the USAMRMC as a part of their responsibility to protect human subjects in research. Research records must be stored in a confidential manner so as to protect the confidentiality of subject information.

The recipient is required to adhere to the following reporting requirements:

Submission of substantive modifications to the protocol, continuing review documentation, and the final report as outlined in the USAMRMC ORP approval memorandum.

Unanticipated problems involving risks to subjects or others, subject deaths related to participation in the research, clinical holds (voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, must be promptly reported to the USAMRMC ORP.

Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRMC ORP HRPO.

The knowledge of any pending compliance inspection/visits by the FDA, ORP, or other government agency concerning this clinical investigation or research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies, and any instances of serious or continuing noncompliance with regulatory requirements that relate to this clinical investigation or research, must be reported immediately to the

USAMRMC ORP.

Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award.

DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRMC ORP Human Research Protection Office submission instructions can be accessed at https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo.

Prohibition of Use of Human Cadavers (NOVEMBER 2015)

Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens under this award shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, 20 April 2012 (https://mrmc.amedd.army.mil/index.cfm?pageid=research_ protections.overview).

The USAMRMC Office of Research Protections (ORP) is the Action Office (usarmy.detrick.medcom-usamrmc.other.hrpo@mail.mil ) for this policy. Approval must be obtained from the USAMRMC ORP. Award contractors must coordinate with the supporting/funding Army organization to ensure that proper approvals are obtained. ORP will issue written approvals to begin under separate notification to the contractor. Written approval to proceed from the USAMRMC ORP is also required for any subrecipient that will use funds from this award to conduct RDT&E, education or training involving human cadaveric specimens.

Recipients must promptly report problems related to the conduct of the activity involving cadavers or the procurement, inventory, use, storage, transfer, transportation, and disposition of cadavers to the USAMRMC ORP

Recipients must maintain complete records of the activity.

The USAMRMC or designees must be permitted to observe the activity upon request and/or audit activity records to ensure compliance with the approved protocol or applicable regulatory requirements.

Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award.

Prohibition of Use of Laboratory Animals (NOVEMBER 2015)

Notwithstanding any other terms and conditions contained in this award or incorporated by reference herein, you are expressly forbidden to use or subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the USAMRMC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for this award will be issued to you in the form of an approval letter from the USAMRMC ACURO. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, you must maintain, and upon request from ACURO, submit animal usage information.

Non-compliance with any of these terms and conditions may result in withholding of funds and/or the termination of the award.

The Animal Care and Use Office requirements can be accessed at https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.acuro.

REGULATORY RIGHTS IN EVENT OF PRODUCT DEVELOPMENT FAILURES (June 2015)

(USAMRAA)

This contract includes research with an investigational drug, biologic or medical device that is regulated by the U.S.

Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is a possibility that this contract will result in the FDA clearance and commercialization of the Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate-Severe Traumatic Brain Injury (POI TBI or the “Technology”). The Contractor is the sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to FDA) that controls the research under this contract. As the sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.

This provision protects the return on research and development investment made by the U.S. Army Medical Research and Materiel Command (USAMRMC) in the event of certain regulatory product development failures related to the Technology.

The Contractor agrees to the following:

a. Contractor will, within three (3) business days of receipt, provide USAMRMC with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that USAMRMC representatives are given advance notice of and are invited to participate with at least two (2) representatives in any formal or informal sponsor meetings with FDA;

b. If contract is to be terminated or is about to expire prior to the time the Contractor obtains FDA approval or clearance ; or the Contractor fails to commercially market the regulated technology within ____ [insert “three (3)” or an appropriate timeframe] years after the FDA issues approval or clearance, the Contractor, upon the request of the Government:

(1) shall transfer possession, ownership and sponsorship or holder ship of any Regulatory Application (including any associated expedited review designation, priority review voucher, or marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory information related to the Technology to USAMRMC or its designee;

(2) shall inform FDA of the transfer of sponsorship or holder ship of the Regulatory Application transferred under section (c) (i) above.

c. The terms of this provision and its derivative obligations:

(i) will be included in any license, sale or transfer by the Contractor to a third party of any intellectual property covered by section (b) above.

(ii) will survive the acquisition or merger of the Contractor by or with any third party.

(iii) will be included in any subcontracts relating to the development of the Technology.

(iv) will survive the expiration of this contract.

SAFEGUARDING PROPRIETARY INFORMATION (June 2015) (USAMRAA)

a. "Proprietary information" shall mean all information, whether disclosed orally, in writings, by drawings, or otherwise relating to the work to be performed under this contract, whether proprietary to the Government or one of its collaborating partners. Proprietary information includes, but is not limited to, information regarding properties, formulae, structures, manufacturing processes, and test results. Information ceases to be proprietary when it is generally available to the public or is available from sources other than the Department of the Army. All information submitted to the contractor under this contract shall be presumed to be proprietary to the Department of the Army or one of its collaborating partners until the Department of the Army announces to the contrary.

b. The contractor shall safeguard proprietary information both during and after the term of this contract, and shall neither appropriate, nor disclose, nor make unauthorized use of the proprietary information received under this contract. The requirements of this paragraph include, but are not limited to, the following:

(1) Maintain a high degree of physical security over proprietary information at all times;

(2) Discussion of proprietary information only among contractor's employees whose duties and responsibilities require knowledge of that information; and,

(3) Elimination of proprietary information in open publications by the contractor and its personnel.

c. The contractor shall require all personnel who receive proprietary information to execute the statement in paragraph d below when this contract becomes effective or when first employed (if employed after the contract becomes effective). All statements executed pursuant to this paragraph shall be forwarded to the U.S. Army Medical Research Acquisition Activity Contracting Officer when this contract terminates, and/or when the employment ends, or and/or upon request of the Contracting Officer.

d. The following statements shall be executed pursuant to paragraph c above and when completed, placed in the official contract file:

I hereby acknowledge that I (insert contractor’s name here) have been informed that our duties may require that I have access to proprietary information.