RFP W81XWH-21-R-0054 SM Wearable TBI Device.pdf

CODE

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PAGE(S)

until local time

A X B X C

D

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X G F 55

56 - 64 H 65 - 73

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 73

(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)

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 4

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

5 - 22 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

24 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 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

25 - 53

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 Oct 2021

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH21R0054

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 Job

Labor for SM Wearable TBI Prevention Dev

CPFF

Labor for Service Member (SM) Weareable Traumatic Brain Injury (TBI) Prevention Devices.

FOB: Destination

PSC CD: AN13

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

ODCs for SM Wearable TBI Prevention Dev

COST

Other Direct Costs (ODCs) for Service Member Wearable Traumatic Brain Injury (TBI) Prevention Devices.

FOB: Destination

PSC CD: AN13

ESTIMATED COST

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0003 Job

CDRL A001

CPFF

Contract Data Requirements Lists (CDRL) A001 - Non-clinical Animal Study Protocol FOB: Destination

PSC CD: AN13

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0004 Job

CDRL A002

CPFF

Contract Data Requirements Lists (CDRL) A002 - Systems Engineering Documents FOB: Destination

PSC CD: AN13

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0005 Job

CDRL A003

CPFF

Contract Data Requirements Lists (CDRL) A003 - Pivotal Study Clinical Protocol FOB: Destination

PSC CD: AN13

ESTIMATED COST

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0006 Job

CDRL A004

CPFF

Contract Data Requirements Lists (CDRL) A004 - FDA Submission Packet FOB: Destination

PSC CD: AN13

ESTIMATED COST

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES (SOO)

Original Date: 28 May 2021

Revised Date: 06 October 2021

Title: Service Member Wearable Traumatic Brain Injury Prevention Devices

Requiring Activity Name: The U.S. Army Medical Material Development Activity (USAMMDA)

Program Name: Traumatic Brain Injury Prevention

1. PURPOSE/OBJECTIVE

The purpose of this SOO is to develop an U.S. Food and Drug Administration (FDA) cleared wearable device to prevent or reduce the risk/severity of traumatic brain injury (TBI) that meets or exceeds the specifications/requirements listed in the table below.

Attribute: Threshold: Objective:

U.S. FDA Approval for intended use that encompasses government needs

U.S. FDA Clearance (Approval) U.S. FDA Clearance (Approval)

Efficacy - Reduced risk or severity of TBI (blast pressure wave exposure: from missiles, artillery, improvised explosive device, occupational use of shoulder-launched weapons, out-going mortar, breaching charges)

Statistically significant reduction of >50% in TBI severity, when compared with control group, and as confirmed by clinically relevant end points (ex: computed tomography (CT) scan, magnetic resonance imaging (MRI), clinical diagnosis).

Statistically significant reduction of >95% in TBI severity, when compared with control group, and as confirmed by clinically relevant end points (ex: CT, MRI, clinical diagnosis).

Efficacy - Reduced risk or severity of TBI (blunt force trauma [low velocity impact];

accelerative/decelerative force exposure incurred during parachute landing and normal garrison Warrior task trainings and mounted/unmounted field exercises

Statistically significant reduction of >60% in TBI severity, when compared with control group, and as confirmed by clinically relevant endpoints. (ex. CT, MRI, clinical diagnosis).

Statistically significant reduction of >99% in TBI severity, when compared with control group, and as confirmed by clinically relevant endpoints. (ex. CT, MRI, clinical diagnosis).

Weight: <5 pounds <3 pounds Size: Must be a Soldier-worn device (see operational environment, context of use, and field suitability below)

Must be a Soldier-worn device (see operational environment, context of use, and field suitability below)

Useable lifetime Performs as intended and within pre-determined specifications for > 2 years after manufacture

Performs as intended and within pre-determined specifications for > 5 years after manufacture 100% efficacy after 5 years of continuous wear

Operational Environment Performs as intended and within pre-determined specifications when

Performs as intended and within pre-determined specifications when used in the following temperature range: from -27oF to 120oF used in the following temperature range: from -55oF to 140oF

Will perform as intended and within pre-determined specifications when stored in the following conditions for up to 18 months: -27oF to 140oF, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when stored in the following conditions for up to 4 years: -55oF to 140oF, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to transit drop, unpackaged, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to transit drop, unpackaged, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to loose cargo transportation, packaged, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to loose cargo transportation, packaged, as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to insect repellant contamination as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to insect repellant contamination as described in MIL-STD-810G

Will perform as intended and within pre-determined specifications when subject to salt fog exposure as described in MIL-

STD-810G

Will perform as intended and within pre-determined specifications when subject to salt fog exposure as described in MIL-

STD-810G

Applicable context of use Military garrison training and field exercises

Military operational scenarios and garrison training and field exercises

Safety in Military use Demonstrates no medical complications/adverse medical events and does not complicate treatment for the following conditions/injuries: Severe TBI, Penetrating TBI, Brain Hemorrhage, Head, Neck, and Airway injuries

Demonstrates no medical complications/adverse medical events and does not complicate treatment for the following conditions/injuries: Severe TBI, Penetrating TBI, Brain Hemorrhage, Head, Neck, and Airway injuries

Demonstrates no injurious/adverse medical effect or irritation when used over the following prolonged periods:

>24 consecutive hours of use or >8 hours/day for 10 or more consecutive weeks)

Demonstrates no injurious/adverse medical effect or irritation when used over the following prolonged periods:

>24 consecutive hours of use or >8 hours/day for 24 or more consecutive weeks)

Field Suitability Retains full efficacy, fits, and does not interfere with the function of military uniforms, personal protective equipment, communications gear, and weapons.

Retains full efficacy, fits, and does not interfere with the function of military uniforms, personal protective equipment, communications gear, and weapons.

Emits no electromagnetic radiation and does not interfere with

Emits no electromagnetic radiation and does not interfere with electromagnetic radiation emitted by devices electromagnetic radiation emitted by devices

Infrared signature is capable of being disguised by >99% using external applications

Has no native infrared signature

Fit Does not restrict movement or interfere with common Warrior tasks greater than 10% as assessed by user feedback

Does not restrict any movement or interfere with any common Warrior tasks as assessed by user feedback improper use, fit, or accidental misplacement elicits a corrective response by the user in order to maintain 100% efficacy any improper use, fit, or misplacement is automatically corrected in order to maintain 100% efficacy

Maintenance / Mean time between failures

Once per year (or less) maintenance using tools or practices common to military personal protective equipment (PPE) maintenance in mobile military units.

No failures when used as intended and as per useable life.

No maintenance required.

No failures when used as intended and as per useable life.

Training Requires no training beyond multi-page instruction manual or 10 minute verbal/visual instruction

Requires no training

Technology Readiness Level (Appendix A) 6 8

The long term goal of the Traumatic Brain Injury Prevention Program is to develop a FDA approved, Soldier wearable device that will meet the U.S. Military needs to prevent brain injuries and maintain the safety and performance by those exposed to potentially concussive events including, but not limited to, impact with an object, overpressures from occupational exposures to certain weapon systems (ex. breaching charges, outgoing mortars and shoulder-launched weapons), exposure to blast from artillery, missiles, and improvised explosive devices. To meet this objective, the vendor will be expected to perform all necessary research and development activities to achieve a device with the listed attributes and ensure FDA clearance is achieved and maintained.

2. BACKGROUND

Traumatic Brain Injury (TBI) is a significant health issue for our Service Members with over 380,000 active duty Service Members who have received a TBI diagnosis from 2001 to 2018 (Defense and Veterans Brain Injury Center, 2018). TBI can result in mild to severe complications for the Service Member (SM). SMs engaged in combat and training operations are at risk for TBI. Brain injury from blast exposure has been considered a cardinal injury of the Global War on Terrorism and will likely remain an issue in future combat operations. The U.S. Army recognizes a requirement to protect Soldiers from TBI but current methods remain inadequate. Therefore, the Army must develop innovative technologies that improve protection against TBI. To address this issue, USAMMDA identified the need for a solution to prevent or reduce the risk/severity of traumatic brain injury.

Currently, PPE including the Advanced Combat Helmet (ACH), reduces the risk for TBI, but is not fully adequate for the range of concussive events that Warfighters may encounter, such as pressure waves from missiles, artillery, improvised explosive devices, shoulder-fired weapons or blunt and penetrating impact from ballistic/environmental fragments.

In a multi-domain operation (MDO), large scale combat operation (LSCO) with a near peer adversary, changes to current medical concepts of operations (CONOPS) and the introduction of novel medical assets are required to prevent significant increases in TBI casualties, morbidity and mortality. Based on the limitations on evacuation and

Class VIII resupply imposed by these future operational conditions there will be a need to lower the casualty burden at far forward roles of care by preventing TBI in Warfighters

3. SCOPE OF EFFORT

The goal of the Government is to develop an FDA approved, Soldier-wearable device that will meet the U.S.

Military needs to prevent brain injuries and maintain the safety and performance by those exposed to potentially concussive events including, but not limited to, blast pressure waves generated by missiles, improvised explosive devices; occupational exposure to overpressures from relevant weapon systems (ex. breaching charges, outgoing mortars/artillery, and shoulder-launched weapons); and impact by an object. To meet the Military need, the prototype and eventually the final marketed production device will possess, at a minimum, the threshold attributes and eventually meet the objective attributes stipulated in Section 1. The vendor will perform and be responsible for any and all research and development activities, manufacture, compliance with applicable FDA regulations including 21 Code of Federal Regulations (CFR) Part 312 sub-part D (as it pertains to FDA-Sponsorship of clinical trials), and will be expected to serve as the sponsor for device submission to the FDA for pre-market approval of the device for the intended use/indication for use. The vendor will produce prototype devices and test and production representative devices for limited user testing, operational assessment (OA) and initial operational test and evaluation (IOTE), and clinical evaluation to support a pre-market submission to the FDA for an intended use/indication for use that encompasses Government needs. The vendor will also produce a final FDA-approved device in the quantity required by the Government. The vendor shall develop the device in accordance with all applicable State laws, Federal laws, Department of Defense (DoD) regulations, and U.S. Army regulations.

Aim 1 will accomplish the research and development of a device with the stipulated attributes, and production of prototype devices to be assessed in limited user testing and environmental resilience testing.

Aim 2 will accomplish production of representative test and production articles to facilitate the conduct of operational assessment and initial operational test and evaluation, respectively.

Aim 3 will accomplish clinical evaluation of the device and FDA pre-market approval of the device for the intended use/indication for use.

The Contractor shall conduct a pivotal clinical study that supports the proposed intended use and indication for use of the device. This study shall encompass creating a clinical study protocol and documentation supporting the clinical study and conducting the clinical trials in a manner that successfully supports the Contractor’s regulatory plan.

The Contractor shall provide sufficient production representative articles for the clinical trials including a contingency plan for replacement of defective and/or production articles that may be lost or damaged during a pivotal clinical trial

The Contractor shall write, edit, and submit the FDA submission packet, and respond promptly to questions from the FDA and the Government including requests for information and data.

Aim 4 will accomplish scaling of production to fulfill the potential device quantity need of the Government.

4. PLACE AND PERIOD OF PERFORMANCE

The place of performance is expected to be within the Offeror’s research and commercial area of operations and within any industrial and academic partners’ area of operations. The Offeror is to determine the place of performance in its Technical Proposal.

The period of performance (PoP) is thirty-six (36) months.

FDA approval must be achieved before performance on Aim 2 can start.

Deliverable 20 for Aim 2 must be completed before performance on Aim 3 can start.

Deliverable 22, 23, and 24 for Aim 3 must be completed before performance on Aim 4 can start.

5. CONSTRAINTS

ANTITERRORISM / OPERATIONS SECURITY

5.1. Access and general protection policy and procedures.

Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

5.2. For contractors not eligible for CAC, but requires access to DoD facility or installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations. Contractor personnel must be escorted by a U.S. DoD Service Member or civilian employee at all times they are inside a U.S.

government facility.

5.3. iWATCH training.

The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 60 calendar days after contract award.

KEY PERSONNEL

a. Solicitation Requirement:

(1) The Government has identified the following positions to be filled by Key Personnel. The Offeror may propose alternate and/or additional positions as Key personnel.

Position Title: Program Manager

(2) For all Key Personnel positions, provide an attachment naming the individuals proposed to fill Key Personnel positions along with a description of the portion of the solicitation’s Performance Work Statement that each individual is being proposed to perform.

(3) A resume is required for all individuals proposed to fill Key Personnel positions. Do not submit resumes for all labor proposed, only for those Key Personnel identified above. A signed a letter of intent is required for those individuals proposed as Key Personnel who are not current employees of the prime contractor responding to this requirement. This includes letters of intent for key personnel proposed by subcontractors, teaming partners and consultants. A letter of intent is not required for individuals proposed as key personnel who are current employees of the prime contractor.

(4) The resumes must provide thorough and detailed documentation of the experience, abilities, and background for proposed Key Personnel or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

b. Contract Requirement:

(1) The following positions have been identified to be filled by Key Personnel proposed for this award.

Position Title: Program Manager

(2) The approved Personnel identified to fill the Key Personnel positions shall be utilized as necessary to fulfill the requirements of this contract.

(3) The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or change in employment conditions (e.g.

termination, change in position, etc.). In any of these events, the contractor shall promptly notify the KO in writing and provide the information required by paragraph 4 below.

(4) All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the KO needed to approve or disapprove the proposed substitution(s). Any proposed substitute or replacement key personnel shall have qualifications comparable to the individual being replaced, taking into account the requirements of the PWS. The KO or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

(5) If any of the listed Key Personnel are subcontractor personnel, the contractor shall flow down the substance of this instruction in any subcontract which is awarded in support of this contract.

(End of Requirement)

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (OCI)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage.

An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the

Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement (Attachment 6) at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract.

Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

(End of Requirement)

REGULATORY RIGHTS IN EVENT OF PRODUCT DEVELOPMENT FAILURES

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 expected that this contract will result in the FDA clearance and commercialization of the _____________________ [describe technology] (___________ [describe short-title for the technology or acronym] 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 Army Medical Research and Development Command (USAMRDC) 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 USAMRDC with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that USAMRDC 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 the FDA;

b. If the contract is to be terminated for default 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 time frame] 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 USAMRDC or its designee;

(2) shall inform FDA of the transfer of sponsorship or holder ship of the Regulatory Application transferred under section (b)(1) above.

(3) shall, upon the request of the Government, negotiate in good faith and upon fair and reasonable terms to provide the U.S. Government with a non-exclusive license to any intellectual property, including but not limited to technical data, held by contractor that relates to the Technology that would permit the U.S. Government to pursue commercialization of the Technology with a third party.

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

(1) 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;

(2) will survive the acquisition or merger of the Contractor by or with any third party;

(3) will be included in any subcontracts relating to the development of the Technology;

(4) will survive the expiration of this contract.

(End of Requirement)

PROHIBITION OF USE OF HUMAN SUBJECTS

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, shall not begin until the USAMRDC’s Office of Research Protections (ORP) provides authorization that the research may proceed. Written approval to begin research will be issued from the USAMRDC ORP, under separate notification to the contractor. Written approval from the USAMRDC ORP is also required for any subcontractor that will use funds from this contract to conduct research involving human subjects.

*This prohibition does not apply to research under this contract that solely uses only one or both of the following types of human anatomical substances to accomplish its aims: (1) established/existing commercially available human cell lines; (2) established/existing patient-derived xenograft (PDX) models.

Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the USAMRDC ORP. Complete study records shall be maintained for each human research study and shall be made available for review by representatives of the USAMRDC. Research records shall be stored in a confidential manner in accordance with FAR 52.224-2.

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

Submission of substantive modifications to the protocol, continuing review documentation (if applicable), and the final report as outlined in the USAMRDC 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 contractor, the Sponsor, or regulatory agencies, shall be promptly reported to the USAMRDC ORP.

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 noncompliance with regulatory requirements that relate to this clinical investigation or research, shall be reported immediately to the USAMRDC ORP.

Non-compliance with these terms and conditions may result in withholding of payments and/or the termination of the contract. The USAMRDC ORP Human Research Protection Office submission instructions can be accessed at https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/hrpo.

(End of Requirement)

PROHIBITION OF USE OF HUMAN CADAVERS

PROHIBITION - READ FURTHER FOR DETAILS

Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens (with the exception of activities solely using established/existing human cadaveric cell lines under this contract shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, 5 November 2019 (https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/hrpo).

The USAMRDC 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 USAMRDC ORP. Contractors must coordinate with the Contracting Officer Representative (COR) 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 USAMRDC ORP is also required for any subcontractor that will use funds from this award to conduct RDT&E, education or training involving human cadaveric specimens.

Contractors 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 USAMRDC ORP.

Contractors must maintain complete records of the activity.

The USAMRDC 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 payments and/or the termination of the contract.

(End of Requirement)

PROHIBITION OF USE OF LABORATORY ANIMALS

PROHIBITION - READ FURTHER FOR DETAILS

Notwithstanding any other terms and conditions contained in this contract or incorporated by reference herein, the contractor is expressly forbidden to use or subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the USAMRDC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for this contract will be issued in the form of an approval letter from the USAMRDC ACURO to the contractor. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the contractor 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 payment and/or the termination of the contract.

The Animal Care and Use Office requirements can be accessed at https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/acuro.

(End of Requirement)

6. Deliverables

NOTE: For this requirement “deliver” means that the Contracting Officer’s Representative (COR) is in possession of the deliverable.

6.1 The Contractor shall deliver the following:

6.1.1. A kick off meeting shall be conducted no later than (NLT) fourteen (14) days after contract award. The contractor will be contacted by the COR to setup an in person or TCON contract Kick off meeting (Deliverable 1) with the COR, Product Manager and Government representatives to review and document project requirements.

6.1.2. Provide monthly Contractor's Progress, Status, and Management Reports (Deliverable 2) 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 Integrated Master Schedule (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.

6.1.3. The Contractor shall provide twenty (20) representative test articles (Deliverable 3) including consumables, manuals (operator and maintenance in both paper and electronic versions), training materials and other similar items as applicable, within eighteen (18) calendar months of the contract start date. The Contractor shall provide a hands on demonstration on the use of and maintenance of the test articles in a meeting with the COR and other Government Representatives that will view the test articles at Fort Detrick, Maryland. The Contractor will be contacted by the COR after test article delivery to schedule the meeting. The date of the demonstration should be finalized no later than (NLT) fifteen (15) calendar days after delivery of the test articles.

6.1.4. No Later Than ten (10) calendar days prior to the expiration of the base task, the Contractor shall submit a gap analysis with cost report (Deliverable 4) to the 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 for the wearable TBI prevention device, a manufacturing capability plan, remaining estimated costs to achieve FDA market authorization, and an estimated five (5) year life cycle cost for the device and consumables.

The report will also include the commercial viability of the device.

6.1.5. The Contractor shall provide a Product Development Plan (Deliverable 5) describing all proposed activities that will be managed in a sound, reasonable way to achieve the Government’s objectives and how the Offeror will ensure that all deliverables produced will be acceptable prior to delivery to the Government. The plan should be in sufficient detail, so the Government may assess associated project risks and should include, but is not limited to: a) Product characterization of the wearable TBI prevention device to reach threshold values for the Performance Attributes listed in the SOO, b) Analysis of technical and schedule risks associated with the proposed approach, and

c) Regulatory timeline that includes sequence and timing of key regulatory activities, tasks, and decision points (meetings/communications with FDA, submissions including authoring and publishing, and marketing application submission)

6.1.6. The Contractor shall provide a Project Management Plan (PMP) (including organization chart) (Deliverable

6) that includes, but is not limited to, an 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.

6.1.7. The Contractor shall provide and implement a written Quality Management Plan (Deliverable 7) to ensure that all activities of the project are managed in a sound, reasonable way in conformance to the Government’s and FDA regulatory requirements, including but not limited to, those found in 21 CFR 820, Quality System Regulation;

and that all deliverables produced are acceptable prior to delivery to the Government. Under this Quality Management 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 Management Plan shall be updated at least quarterly or at the Government’s request.

6.1.8. Develop and implement a FDA communication plan (Deliverable 8) that includes but is not limited to, meetings, communications, submission packets, inspections and enforcements that occurs before or after FDA approval. 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. The FDA communication plan shall be updated annually or at the Government’s request. The Contractor shall include the COR or a Government designee identified by the COR in all meetings both formal and informal with the FDA.

6.1.9. The Contractor shall provide copies of meeting packages for both formal and informal meetings with the FDA to the COR at least 10 business days prior to the FDA meetings (Deliverable 9).

6.1.10. 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 (Deliverable 10). If submissions have occurred prior to the POP start date, the contractor shall provide copies of any submissions, to date.

6.1.11. The Contractor shall submit a Regulatory Development Plan (Deliverable 11) detailing project objectives for compliance with FDA requirements for eventual product approval to market and licensure to an indication that will meet U.S. Military needs. Indications for use, and implementation plan for the required clinical trials shall be included. The plan shall be described in sufficient detail to allow the Government to assess fulfillment of requirements, technical and schedule risks, and adherence to FDA regulations and guidance and shall include, but is not limited to, approaches for the following activities: (a) Regulatory Strategy (pathway) for initial FDA regulatory market authorization, any device changes or modifications after FDA approval 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; current development/regulatory status of the product; previous FDA interactions or submissions; and data collection plan; (b) Regulatory timeline that includes sequence and timing of key regulatory activities, tasks, and decision points (meetings/communications with FDA, submissions including authoring and publishing, and marketing application submission), (c) Matrix of product claims, intended use/indications for use, and plan for studies to support claims, (d) Clinical Trial sites, Clinical Research Organization, clinical data management, data validation and quality control, (e) Potential predicate devices (if applicable), (f) Life Cycle Considerations – describe future device generations, modifications, indications, or claims that will build on prior/initial/subsequent approvals or clearances, (g) Analysis of technical and schedule risks associated with the proposed approach. Update as needed based on FDA feedback or Government request.

6.1.12. Provide the name of a Contractor representative (Deliverable 12) to participate as a member of the Government Working Group (WG) within 10 calendar days of the POP start date. The Contractor WG 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 Representative will be excused when government-only materiel is discussed. The contractor shall notify the COR within 48 hour if there is a change in the WG member.

6.1.13. The Contactor shall report any significant positive or negative deviation to the schedule or scope of a task (Deliverable 13) within 24 hours 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 reports.

6.1.14. The Contractor shall submit a Manufacturing Development 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).

6.1.15. 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 10 calendars after the POP start date. The Contractor shall report actual progress and Spend Plan updates in the Monthly Progress Report.

6.1.16. If non-clinical animal studies are proposed, the Contractor shall provide copies of the non-clinical animal study protocol, any associated documentation, approvals, copies of the in-progress study results, and completed study results within 15 calendar days of Government request, as revised, and prior to contract expiration (Deliverable 16, Exhibit A, Contract Data Requirements List (CDRL) A001). The Contractor shall conduct the animal study in accordance with 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies.

6.1.17. The Contractor shall provide the COR with System Engineering documents (Deliverable 17,…