b - SSJ redacted (Artinis Brite).docx

MEMORANDUM

Subj: SOLE SOURCE JUSTIFICATION TO ACQUIRE ARTINIS BRITE23 NIRS (NEARINFRARED SPECTROSCOPY) SYSTEM. (PR 1300878442)

1. Identification of the agency and the contracting activity, and specific identification of

This is a sole source justification. Contracting activity is the Naval Sea Systems Command, Naval Surface Warfare Center, Panama City Division (NSWC PCD), 110 Vernon Avenue, Panama City, FL 32407-7001 (Contracts Division Code 02).

2. Nature and/or description of the action being approved.

This action will award a Purchase Order, on a sole source basis, to Artinis Medical Systems, Einsteinweg 17, 6662 PW Elst, The Netherlands to acquire the Brite23 NIRS (Near-Infrared Spectroscopy) system with its associated hardware and software. Artinis Brite23 is a proprietary hardware and software package in the form of a skull-cap, receiver, laptop, and dataacquisition/analysis program. It provides in real time the calculation of oxy-, deoxy-, total hemoglobin and tissue saturation index (TSI) of the brain.

3. A description of the supplies or services required to meet the age (including the estimated value).

This procurement is for the Atinis Brite23 NIRS (Near- and associated hardware and software consisting of:

Qty Brite23 NIRS caps, with 7 receivers and 11 transmitters 1

Analyzing unit laptop (13inch, i5 processor) 1

Internal battery 2

Battery charger cord 2

Washable neoprene head caps (4 sizes) 2

Optode holders (2 sets) 2

USB Bluetooth dongle 2

Manual (pdf format) 1

Pelican case 1 personnel. This memo does not authorize acquisition for other requirements. This acquisition will be conducted using simplified acquisition procedures with a total dollar value above micropurchase levels, but not exceeding the simplified acquisition threshold of $250,000.00. The items will be delivered within 30 days after award of the order. This procurement will be funded with FY 2020 Operation and Maintenance, Navy (OMN) funds.

4. Identification of the justification rationale and, if applicable, a demonstration of the

This acquisition is conducted under the authority 10 U.S.C. 2304(c)(1) FAR 6.302-1(a)(2)(i) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

NAVAIR and PMA-265 have tasked XXXX to investigate the possible connection between decompression sickness and the physiological episodes experienced by aviators of the F/A-18 and T-45 community. Cognitive testing and ability to focus on a task will be one of the outcomes measured during testing. The equipment is being used to provide quantifiable and objective measures of decompression stress related to physiological episodes reported in the aviation community. In addition, it will be utilized in multiple research projects XXXX.

The Artinis Brite23 NIRS (Near-Infrared Spectroscopy) system will support the upcoming research NEDU will conduct investigating the possible connection between the physiological episodes experienced by aviators of the F/A-18 and T-45 community. NEDU has been tasked by NAVAIR and PMA-265 to perform this research. Artinis software and hardware will be used to measure and record brain oxygenation in the test subjects pre-, post-, and 24 hours post-protocol. Adequate oxygen delivery to the aviator is critical in a tactical aircraft such as the F/A-18 and has been shown to be a potential culprit for pressure-related Physiological events. Hypoxia can produce symptomology similar to those manifested in PEs.

The Artinis Brite23 NIRS (Near-Infrared Spectroscopy) system is critical to the completion of this study and will provide a vital results as well as more substantial conclusions for NAVAIR and PMA-265. Artinis is the premier provider of Near-Infrared Spectroscopy measurement devices designed to be worn on the skull. The Navy Experimental Diving Unit has used and operated Artinis NIRS systems before and its researchers possess significant amount of expertise and experience. Other systems do not have similar capabilities and options necessary to complete the required testing.

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 13.106(b).

The Contracting Officer has determined that the order represents the best value and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

This requirement will be synopsized on the Commercial Opportunities on the beta.SAM.gov website per FAR Part 5.2. No additional market research was conducted for the reasons specified in paragraph 4 above.

7. Any other facts supporting the justification.

None

8. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

As stated previously Artinis is the premier provider of Near-Infrared Spectroscopy measurement devices designed to be worn on the skull. Other systems do not have similar capabilities and options necessary to complete the required testing.

Section C – Specifications

Minimum Requirements for Access to Controlled Unclassified Information (CUI): Prior to access contractor personnel requiring access to DON controlled unclassified information (CUI) or "user level access to DON or DoD networks and information systems system security and network defense systems or to system resources providing visual access and/or ability to input delete or otherwise manipulate sensitive information without controls to identify and deny sensitive information" contractors must have clearance eligibility or submit an Electronic Questionnaire for Investigation Processing (SF 86) to NSWC PCD Security for processing and subsequent adjudication by the DOD Consolidated Adjudications Facility.

Minimum Protection Requirements for Controlled Unclassified Information: Security classification guides (OPNAVINST 5513 series) and unclassified limited documents (e.g. FOUO Distribution Statement Controlled) are not authorized for public release and therefore cannot be posted on a publicly accessible webserver or transmitted over the Internet unless appropriately encrypted.

Controlled Unclassified Information (CUI): Controlled unclassified information (CUI) is official information that requires the application of controls and protective measures for a variety of reasons and has not been approved for public release to include technical information proprietary data information requiring protection under the Privacy Act of 1974 and Government-developed privileged information involving the award of contracts. CUI is a categorical designation that refers to unclassified information that does not meet the standards for National Security Classification under Executive Order 13526 but is (a) pertinent to the national interest of the United States or to the important interests of entities outside the Federal Government and (b) under law or policy requires protection from unauthorized disclosure special handling safeguards or prescribed limits on exchange or dissemination.

For Official use Only (FOUO) is a document designation not a classification. This designation is used by Department of Defense (DoD) and a number of other federal agencies to identify information or material which although unclassified disclosure to the public of the information would reasonably be expected to cause a foreseeable harm to an interest protected by one or more provisions of the FOIA. This includes information that qualifies for protection pursuant to the provisions of the Privacy Act of 1974 as amended. FOUO must be marked controlled and safeguarded in accordance with DoD 5200.01 Vol. 4 DoD Information Security Program: Controlled Unclassified Information (CUI) February 24 2012

Security of Unclassified DoD Information on Non-DoD Information Systems (DoD 8582.01)

DoD policy: adequate security be provided for all unclassified DoD information on non-DoD information systems. Appropriate requirements shall be incorporated into all contracts grants and other legal agreements with non-DoD entities.

Information Safeguards are applicable to unclassified DoD information in the possession or control of non-DoD entities on non-DoD information systems to the extent provided by the applicable contract grant or other legal agreement with the DoD.

Information Safeguards

Unclassified DoD information that has not been cleared for public release may be disseminated by the contractor grantee or awardee to the extent required to further the contract grant or agreement objectives provided that the information is disseminated within the scope of assigned duties and with a clear expectation that confidentiality will be preserved. Examples include:

a. Non-public information provided to a contractor (e.g. with a request for proposal)

b. Information developed during the course of a contract grant or other legal agreement (e.g. draft documents reports or briefings and deliverables)

c. Privileged information contained in transactions (e.g. privileged contract information program schedules contract-related event tracking)

It is recognized that adequate security will vary depending on the nature and sensitivity of the information on any given non-DoD information system. However all unclassified DoD information in the possession or control of non-DoD entities on non-DoD information systems shall minimally be safeguarded as follows:

a. Do not process unclassified DoD information on publically available computers (e.g. those available for use by the general public in kiosks or hotel business centers)

b. Protect unclassified DoD information by at least one physical or electronic barrier (e.g. locked container or room logical authentication or logon procedure) when not under direct individual control of an authorized user.

c. At a minimum overwrite media that have been used to process unclassified DoD information before external release or disposal.

d. Encrypt all information that has been identified as CUI when it is stored on mobile computing devices such as laptops and personal digital assistants compact disks or authorized removable storage media such as thumb drives and compact disks using the best encryption technology available to the contractor or teaming partner.

e. Limit transfer of unclassified DoD information to subcontractors or teaming partners with a need to know and obtain a commitment from them to protect the information they receive to at least the same level of protection as that specified in the contract or other written agreement.

f. Transmit e-mail text messages and similar communications containing unclassified DoD information using technology and processes that provide the best level of privacy available given facilities conditions and environment. Examples of recommended technologies or processes include closed networks virtual private networks public key-enabled encryption and transport layer security (TLS)

g. Encrypt organizational wireless connections and use encrypted wireless connections where available when traveling. If encrypted wireless is not available encrypt document files (e.g. spreadsheet and word processing files) using at least application-provided password protected level encryption.

h. Transmit voice and fax transmissions only when there is a reasonable assurance that access is limited to authorized recipients.

i. Do not post unclassified DoD information to website pages that are publicly available or have access limited only by domain or Internet protocol restriction. Such information may be posted to website pages that control access by user identification and password user certificates or other technical means and provide protection via use of TLS or other equivalent technologies during transmission. Access control may be provided by the intranet (vice the website itself or the application it hosts)

j. Provide protection against computer network intrusions and data exfiltration minimally including:

(1) Current and regularly updated malware protection services e.g. anti-virus anti-spyware.

(2) Monitoring and control of both inbound and outbound network traffic (e.g. at the external boundary sub-networks individual hosts) including blocking unauthorized ingress egress and exfiltration through technologies such as firewalls and router policies intrusion prevention or detection services and host-based security services.

(3) Prompt application of security-relevant software patches service packs and hot fixes.

k. Comply with other current Federal and DoD information protection and reporting requirements for specified categories of information (e.g. medical proprietary critical program information (CPI) personally identifiable information export controlled) as specified in contracts grants and other legal agreements.

l. Report loss or unauthorized disclosure of unclassified DoD information in accordance with contract grant or other legal agreement requirements and mechanisms.

m. Do not use external IT services (e.g. e-mail content hosting database document processing) unless they provide at least the same level of protection as that specified in the contract or other written agreement.

Operations Security

Operations Security (OPSEC) is concerned with the protection of critical information: facts about intentions capabilities operations or activities that are needed by adversaries or competitors to bring about failure or unacceptable consequences of mission accomplishment.

Critical information includes information regarding:

- Operations missions and exercises test schedules or locations;

- Location/movement of sensitive information equipment or facilities;

- Force structure and readiness (e.g. recall rosters);

- Capabilities vulnerabilities limitations security weaknesses;

- Intrusions/attacks of DoD networks or information systems;

- Network (and system) user IDs and passwords;

- Movements of key personnel or visitors (itineraries agendas etc.); and

- Security classification of equipment systems operations etc.

The contractor subcontractors and their personnel shall employ the following countermeasures to mitigate the susceptibility of critical information to exploitation when applicable:

- Practice OPSEC and facilitate OPSEC awareness;

- Immediately retrieve documents from printers assessable by the public;

- Shred sensitive and Controlled Unclassified Information (CUI) documents when no longer needed;

- Protect information from personnel without a need-to-know;

- When promulgating information limit details to that essential for legitimacy;

- During testing and evaluation practice OPSEC methodologies of staging out of sight desensitization or speed of execution whenever possible.

Section F - Deliveries or performance F.O.B.

52.247-29 FOB Origin 52.247-34 FOB Destination

Section G - BOTH CLAUSES IN FULL TEXT 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports (Dec 2018) 252.232-7006 Wide Area Workflow Payment Instructions

Section I – Contract Clauses 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) – OVER $150K 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018)

– OVER $30K

52.204-13 System for Award Management Maintenance JUL 2013 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) – OVER $30K 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) – avoids PDS error 52.211-15 Defense Priority and Allocation Requirement (Apr 2008) – DO or DX RATED 52.212-4 Contract Terms and Conditions -- Commercial Items (May 2015) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Mar 2020) Preselected:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statement (Jan 2017) 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) – avoids PDS error 52.233-3 Protest After Award (Aug 1996) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

Select as Applicable for Set Aside Type:

52.219-6 Notice of Total Small Business Set-Aside NOV 2011 – ONLY FOR SBSA

Required:

52.222-50 Combatting Trafficking in Persons (Mar 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.232-33 Payment by Electronic Funds Transfer--System for Award Management JUL 2013

52.213-4 Terms and Conditions—Simplified Acquisitions (Other Than Commercial Items) (Oct 2019) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.243-1 Changes Fixed-Price 52.246-4 Inspection of Services (SHIPPING IS A SERVICE) 52.252-2-Clauses Incorporated by Reference (Feb 1998) – FULL TEXT 252.203-7000 Requirements Relating to Compensation of Former DoD Officials (SEP 2011) 252.203-7002 Requirement to Inform Employees of Whistleblower Rights (Sep 2013) 252.204-7003 Control of Government Work Product (Apr 1992) 252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting (Oct 2016) 252.204-7015 Notice of Authorized Disclosure of Information by Litigation Support (May 2016) 252.211-7003 Item Unique Identification and Valuation (Mar 2016) 252.225-7048 Export Controlled Items (Jun 2013) 252.232-7010 Levies on Contract Payments (Dec 2006) 252.246-7007 Contractor Counterfeit Electronic Part Detection and Avoidance System (not for use on non-commercial contracts) 252.246-7008 Sources of Electronic Parts (not for use on non-commercial contracts) 252.247-7023 Transportation of Supplies by Sea (Apr 2014)

SECTIONS K & L & M IN SOLICITATIONS ONLY

Section K - Representations, certifications, and other statements of offerors or respondents 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements--Representation (Jan 2017) 52.204-8 Annual Representations and Certifications (Mar 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction (Feb 2016) 52.252-1-Solicitation Provisions Incorporated by Reference (Feb 1998) 252.204-7008 Compliance with Safeguarding Covered Defense Information Controls (Oct 2016) 252.213-7000 Notice to Prospective Suppliers on Use of SPRS (Sep 2019)

Section L - Instructions Conditions and Notices to Bidders 52.204-7 System for Award Management (Jul 2013 52.204-22 Alternative Line Item Proposal (Jan 2017) (not for use on non-commercial contracts) 52.211-14 Notice of Priority Rating 52.212-1 Instructions to Offerors—Commercial Items (Mar 2020) 52.212-3 Alt 1 Offeror Representations and Certifications-Commercial Items (Mar 2020) 252.213-7000 Notice to Prospective Suppliers on Use of Supplier Performance Risk System in Past Performance Evaluations (Mar 2018) 252.215-7013 Supplies and Services Provided by Nontraditional Defense Contractors. (Jan 2018)