RFQ No. 75N95025Q00007.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Consulting Services in relation to Medical Device Development under Blueprint MedTech

Initiative – Subject Matter Expert in Neurosurgery

RFQ: 75N95025Q00007

(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95025Q00007 and the solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the Simplified Acquisition Threshold (SAT). A Time and Materials/Labor Hour type of purchase order is contemplated for this requirement.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, dated April 22, 2024.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 541990 - All Other Professional, Scientific, and Technical Services, and the small business size standard is $16.5M. This requirement shall be solicited using competitive procedures as a total small business set-aside.

(v) DESCRIPTION

The Government requires the following services:

The NIH seeks to procure a highly experienced subject matter expert with expertise in neurological medical device research and development. The consultant must be a scientist or engineer with specific experience in neurological medical device research and development through academic research, including research in animal models and testing through clinical research in human patients. The consultant shall provide feedback to the NIH program leadership and technical guidance on medical device development projects within the Blueprint MedTech initiative portfolio. The Contractor will serve as a Blueprint MedTech External Oversight Committee member, providing strategic guidance on Blueprint MedTech projects and grants funded through the Blueprint MedTech initiative.

(vi) Please refer to Attachment 1 – Statement of Work for details and information describing the characteristics and requirements for the required services.

(vii) The Government anticipates award of a time and materials purchase order for this acquisition, and the anticipated period of performance to be twelve (12) months for the

Base Period, with two (2) Option Period of twelve (12) months :

Base Period: December 5, 2024 – December 4, 2025

Option Period 1: December 5, 2025 – December 4, 2026

Option Period 2: December 5, 2026 – December 4, 2027

It is anticipated that the majority of performance shall be remote at the Contractor’s own facility. Conference calls and email shall be the primary mode of communication;

however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as-needed basis. The Contractor must attend one on-site meeting at a Blueprint MedTech hub location (Boston, MA, or greater Washington, DC) per year.

(viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023) is applicable and incorporated by reference into this solicitation.

(ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Each quote will be evaluated in strict conformity with the evaluation factors, utilizing quantitative scores and written critiques. The evaluation will be based upon the demonstrated capabilities of the prospective Contractor in relation to the needs of the project as set forth in the solicitation.

The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered.

All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer.

The Government may request clarifying information from the Contractor, as it relates to its quote.

If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable.

The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements.

A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price.

The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes.

1. Technical Capability and Functionality

We will evaluate a vendor’s technical approach for soundness, practicality, and feasibility to accomplish the tasks and requirements in all Performance Areas of the Statement of Work. We will evaluate the vendor’s technical approach for their ability to meet performance/delivery schedules under the required tasks. Also, we will evaluate their technical proposal on how well it shows a comprehensive understanding of the project’s goals, objectives, and tasks as called for in the Statement of Work (SOW). We will evaluate their understanding of the tasks to be performed, their interrelation and complexity. We will evaluate the vendor’s discussion of anticipated problems and constraints likely to be encountered in performing the work, and their plans, solutions, and approaches to resolving them.

2. PAST PERFORMANCE

The Offeror should provide past performance information. Past performance information shall cover a minimum of 1 year in relevant services and deliveries of comparable services. The Offeror should provide at least one reference for any project identified under the experience factor that has a performance period within the past three years.

For each reference, the offeror should provide: (1) Organization/contracting partner's name; (2) Point of contact's (POC) name and contact information: Current phone numbers. Valid email addresses; (3) Description that precisely explains: General scope of the contract. Specific requirements of the contract. Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

Furthermore, the Government will assess the relative risks associated with each offeror.

Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information.

3. PRICE EVALUATION

Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

4. EVALUATION OF OPTIONS

It is anticipated that any contract awarded from this solicitation will contain option periods. In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of option periods will not obligate the Government to exercise the options. An evaluation of this factor will only be conducted on offerors and quotes who have been determined to be technically acceptable.

(x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (MAY 2024), is applicable and incorporated by reference into this solicitation.

(xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023), applies to this acquisition. See Attachment 2.

(xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to

Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAY 2024), applies to this acquisition. See Attachment 3.

(xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation.

Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; and prompt payment discount terms.

The Contractor shall submit its quote electronically.

Offerors MUST verify the valid certifications, registrations, and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

In addition the vendor Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received no later than November 21, 2024, 2:00 PM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95025Q0007. Responses must be submitted electronically to tracy.cain@nih.gov.

For information regarding this solicitation, please contact Tracy Cain by email at tracy.cain@nih.gov or by phone at (301) 443-6677.

(xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contracting Officer, Tracy Cain, at tracy.cain@nih.gov on or before 2:00 PM EST, November 18, 2024. Fax responses will NOT be accepted.

ATTACHMENTS

- Attachment 1 - Statement of Work (SOW)

- Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (NOV 2023)

- Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders - Commercial Products and Commercial Services (MAY 2024)

- Attachment 4 – Invoice and Payment Instructions

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW)

Consulting Services in relation to Medical Device Development under Blueprint

MedTech Initiative

GENERAL INFORMATION

Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Neurosurgery

The purpose of this requirement is to procure medical device consulting services with appropriate expertise in support of the Blueprint MedTech Initiative, a multi-IC effort to support development of translational neurological medical device technologies. The NIH seeks to procure a highly experienced subject matter expert with expertise in the areas of neurosurgery and medical device regulation. The consultant must be a neurosurgeon board-certified to practice in the United States; the consultant must possess experience in both clinical treatment of patients with various neurological conditions and clinical use of neurological devices. Additionally, the consultant must have previous experience in medical device regulation, specifically in reviewing clinical trial applications and marketing applications for neurological medical devices. The consultant shall provide feedback to the NIH program leadership and technical guidance on medical device development projects within the Blueprint MedTech initiative portfolio. The Contractor will serve as Blueprint MedTech External Oversight Committee member, providing strategic guidance on Blueprint MedTech projects and grants funded through the Blueprint MedTech initiative.

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

• Planning resources to support concept development, team building, needs

Title of Project:

Statement of Need, Purpose, and/or Objective:

Background Information:

Attachment 1 assessment, and other early translational activities.

• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).

• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).

• Advice from industry experts (e.g., meetings with an external oversight committee).

The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and Government.

Each project is directed by the principal investigator with input from industry consultants hired by NIH and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation. Resources and support services are provided without cost to the PI through NIH contracts and NIH-funded specialized centers.

The NIH Blueprint for Neuroscience Research, a consortium of 12 NIH Institutes and Centers that support neuroscience research, established Blueprint MedTech in 2019 and has dedicated $32 million for the initial Blueprint MedTech infrastructure from 2019 to 2027. The funding strategy is designed to translate promising technologies into at least ten successful first-in-human clinical studies within seven years, with at least three projects receiving industry licensing, partnership, or other external investment. To date, as part of a Blueprint MedTech pilot program, seven seedling projects were selected for funding by a program-funded specialized center. At steady-state, the program expects to maintain a portfolio size of 30 projects.

The Blueprint MedTech External Oversight Committee (EOC) is a group of industry, clinical, regulatory, and academic experts in device development and translation whose role is to provide individual and not consensus feedback and suggestions to the Blueprint MedTech Core Team regarding:

• Scientific and strategic input for Blueprint MedTech projects and their proposed research plans

• Suitability of proposed milestones for each project, at each stage

• Project progress relative to milestones and options for going forward

• Strategies for overall portfolio management by Blueprint MedTech

• Strategies for developing and improving the program and addressing problems as they arise

The Institute and Center (IC) Directors who provide the funding for the Blueprint MedTech program make the final decisions regarding project continuation/discontinuation, based on summary input provided by the Blueprint MedTech Core Team based on feedback from the EOC and NIH consultants, broader NIH portfolio considerations, and available funding.

Therefore, EOC guidance is vital to provide objective feedback to Blueprint leadership in managing the Blueprint MedTech project portfolio and the overall program.

The required period of performance is twelve months from the date of award with two twelve-month option periods.

The primary place of performance shall be the Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as-needed basis. The Contractor must attend one on-site meeting at a Blueprint MedTech hub location (Boston, MA, or greater Washington, DC) per year.

A Time and Materials (Labor Hour) Purchase Order with a base period of twelve-months from the date of award and two twelve-month option periods, plus option quantities.

SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

The Contractor shall provide this support while serving on NIH Blueprint MedTech Executive Oversight Committee (EOC). Executive Oversight Committee (EOC) meet both monthly for approximately one hour and on an ad-hoc basis for milestone/introductory calls of Blueprint MedTech projects via teleconference. EOC members are also requested to attend one on site visit to the NIH campus yearly for EOC meetings, and one BP MedTech hub meeting at a Blueprint MedTech hub location (Boston, MA or greater Washington, DC) per year.

The Contractor shall provide consulting support services to the Blueprint MedTech EOC and Blueprint MedTech Program Leadership in relation to the neurological medical device

Period of Performance:

Place of Performance:

Type of Contract Contemplated:

General Requirements:

Specific Requirements:

development programs as follows:

Review operations and processes of Blueprint MedTech grantees/program participants and provide recommendations regarding advancing medical device development studies, validation activities, clinical trials, and directing collaborative research among multiple institutions or teams (if applicable).

Advise regarding suitability and relevance of proposed Blueprint MedTech program milestones, recommend revised milestones for Blueprint MedTech programs as needed, and evaluate project progress relative to established milestones.

Analyze potential opportunities and concerns for future Blueprint MedTech program projects under consideration.

Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to medical device development as they arise.

Mentor Blueprint MedTech program participants executive team and project leaders in scientific entrepreneurship, including but not limited to managing medical device development projects, directing collaborative research among multiple institutions or teams, and regulatory regulations and guidelines, for continued development and improvement of the Blueprint MedTech program.

Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects

Participate in web-enabled virtual meetings and teleconference calls with Blueprint MedTech staff on both a monthly and an ad-hoc-as-required basis.

LEVEL OF EFFORT

It is anticipated that a minimum of 30 hours of support is required in the base period and each option period with additional option quantities at 5 hours per quantity.

OPTIONS

This contract shall contain two 12-month option periods to extend the period of performance, as well as an option quantity for an additional 5 hours which shall be available up to six times in each contract year.

GOVERNMENT RESPONSIBILITIES

No Government furnished property shall be provided. Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party.

Project data will be collected and stored by Blueprint MedTech. Blueprint MedTech will provide data as needed to the Contractor each time it requests service.

OTHER CONSIDERATIONS

The contractor employee working under this contract will be required to attend at least one in-person meeting at the NIH to discuss Blueprint MedTech project issues. Under this and other circumstances as needed, the consultant will be required to travel within the continuous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer’s Representative prior to being finalized or invoiced. Contracting Officer’s Representative-authorized travel shall not exceed $1,200.00 annually. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation.

The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follows:

A PhD, MD, ScD, similar advanced degree in the field of neurosurgery, with associated expertise in medical devices.

Neurosurgeon must be board certified to practice in the United States and have minimum 15 years of experience in both clinical treatment of patients with a variety of neurological conditions, as well as a background in clinical trial review and medical device regulation

Minimum 10 years of experience in the process of reviewing clinical trials and marketing applications for medical device applications seeking FDA approval

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Travel:

Key Personnel:

The following definitions and clauses are required for Information Systems Security:

1. FAR clause 52.239-1, Privacy or Security Safeguards (Section 2.A.2.b.)

2. HHSAR Clause 352.224-71 (Section 2.A.2.e.)

3. FAR 7.105(b)(5) (Section 2.A.7.)

4. FAR 11.002(g) (Section 2.A.7.)

5. FAR 52.239-1(c) (Section 2.D.3.b.)

6. FAR Subpart 4.13 (Section 2.F)

7. FAR Subpart 52.204-9 (Section 2.F)

The Contractor must ensure that any computer system used in the course of this contract shall include the following features:

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

Information Systems Security:

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

The National Institute of Health (NIH) shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” shall be incorporated into any resulting award by reference.

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. Unless it is an “undue burden” or compliant products or services do not exist, the products must conform to Section 508. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Contract employee performing services will be controlled, directed and supervised at all

Data Rights:

Section 508—Electronic and Information Technology Standards:

Confidentiality of Information:

Collaboration Requirements:

Non-Personal Service Statement times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S.

Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and

37.1 of the Federal Acquisition Regulations (FAR).

Statement of Work – Addenda

Article 1. Non-Personal Service Statement:

Contractor employees performing services under this order will be controlled, directed and supervised at all times by management personnel of the contractor.

Contractor employees will perform independent of and without the supervision of any Government official. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

Specifically:

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way to change the contract and that if the other Contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Article 2. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

Stacie Gutowski

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements

The Government may unilaterally change its COR designation.

Article 3. FAR 52.217-9 - Option to Extend the Term of the Contract.

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 calendar days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 calendar days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

(End of clause)

Attachment 2

FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights-

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act ( 31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice. (1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include-

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act ( 31 U.S.C.3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.- (1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act ( 31 U.S.C.3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall-

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the-

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest. (i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if–

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations. (1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would…