RFQ_No._NIHDA-2018-00515.pdf

Solicitation No. NIHDA-2018- 00515

Title: Custom Radiosynthesis of PET Ligands and Use of PET Facility

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

ii. The solicitation number is NIHDA-2018-00515 and the solicitation is issued as a Request for Quotation (RFQ) on an unrestricted basis, as a full and open requirement.

iii. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12— Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. A time and materials type of purchase order is contemplated for this requirement.

iv. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-98 / 05/31/18

v. The North American Industry Classification System (NAICS) code for this procurement is 541690 - Other Scientific and Technical Consulting Services with associated small business size standard of $15 million.

vi. Background:

The Intramural Research Program (IRP) of the National Institute on Drug Abuse (NIDA) Neuroimaging Research Branch (NRB) neuroscientists’ research requires in vivo imaging of the brain and its molecular processes in a way that parallels human imaging research. The purpose of this acquisition is to acquire a service contract to support the NIDA-IRP Biobehavioral Imaging and Molecular Neuropsychopharmacology Unit.

Positron Emission Tomography (PET) is a non-invasive imaging technique that enables picomolar detection (i.e. the highest sensitivity among all non-invasive imaging modalities available) of molecular processes in a living animal. PET compound radiosynthesis requires dedicated instrumentation and skillset which the NIDA-IRP does not have.

Purpose and Objective:

The objective of this contract is to: 1) prepare custom radiosynthesis of specific derivatives either with F18 or C11 on a weekly basis, 2) obtain an estimated 300 rats and/or mice (per contract year), 3) house said animals for the duration of the studies and 4) allow NIDA researchers to have access (approximately 10-50 hrs total per year) to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.

The custom radiotracers will be utilized in ongoing experiments of NRB’s Molecular Neuropsychopharmacology Unit. The objective is to synthesize several radiotracer derivatives, labeled with either F18 or C11 that will bind various targets. There is a specific need to have these PET tracers synthesized in close vicinity to NIDA-IRP so that we can have them available for immediate use in PET imaging experiments.

Other important considerations: Due to their half-life (110 minutes for F18- and 20 min for C11-labeled PET tracers) NIDA needs a facility to be within 2 miles of the NIDA- IRP so that the PET tracers can be quickly transported for immediate use.

vii. Scope of Work:

General Requirements:

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:

Task 1: The Contractor shall prepare radiosynthesis, including custom radiosynthesis, of specific derivatives using either C11 or F18 or other radioisotopes, as requested by the Government.

Task 2: The Contractor shall supply animals (e.g. mice or rats) to NIDA Researchers to use in the experiments.

Task 3: The Contractor shall provide food and housing of the small animals for the duration of each experiment. It is estimated that animals will need housing for up to approximately 3 weeks.

Task 4: The Contractor shall provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.

Specific Requirements:

Specifically, the contractor shall:

For Task 1:

• Prepare routine and custom radiosynthesis compounds in accordance with the type, amount and required date of delivery of radiochemical specified in the Government’s request. The Government will give a lead time of at least 2-3 weeks estimated per request.

• Notify the Government when the synthesized ligands are available for use within five minutes of completing synthesis.

For Task 2:

• Provide the Government with rats or mice as specified by the Government (an estimated 300 animals per contract year) for use in experiments.

For Task 3:

• Provide housing to each animal for approximately up to 3 weeks. Animals will be requested by the Government by the amount, which will vary by experiment, and will be specified at the time of the request.

For Task 4:

• Provide NIDA researchers with access to a small animal PET scanner during the period of performance (an estimated 50 hours required per contract year).

• Provide all electronic data files produced from the PET scans to the Government within twenty-four hours after scanning is complete.

ESTIMATED EFFORT:

It is estimated that the effort required for full performance of this contract would be one (1) part time radiochemist (between 520-1250 hours is estimated), not including effort incidental to animal procurement and care.

OPTION QUANTITIES:

Option Quantity 1: (12 units available per contract year)

As required for the work described under Tasks 1-4, the Contractor shall provide additional labor and materials up to a ceiling of $5,000 per unit.

GOVERNMENT RESPONSIBILITIES

The Government will send specific requests detailing the type and amount of radiochemical required (e.g. in mCi) and will include the requested delivery date.

The Government will also request the number of rats or mice needed at separate timepoints throughout the period of performance. The number and type of animal will vary by experiment and will be specified at the time of each request but it is estimated that approximately 300 total rodents will be required per contract year.

Period of Performance:

The required period of performance is one year with two one year option periods.

• Base Year: 09/25/2018 through 09/24/2019

• Option Year 1: 09/25/2019 through 09/24/2020

• Option Year 2: 09/25/2020 through 09/24/2021

viii. Deliverables and Reporting requirements:

Deliverables will include rats or mice, as specified by the Government, and housing for up to approximately 3 weeks per animal. Animals should arrive at the facility within one to two weeks of placing the order.

The radiotracers themselves are deliverables as are all electronic data files which correspond to the PET scanned animals (scan files such as list, sonogram and img files).

These should be provided to the Government within twenty-four hours of scanning.

Additionally, all other information regarding dose administration and animal information should also be provided within the same time frame.

No formal reports will be required, but all electronic data files which correspond to the PET scanned animals (scan files such as list, sinogram and img files) will be required for each scan.

Publications and Publicity: Contractor shall not, nor is required to, publish any articles of data as a result of fulfilling this requirement.

Confidentiality of Information: All electronic data files and storage for these files which correspond to the PET scanned animals (scan files such as list, sonogram and img files) are to be considered confidential and property of the Government and the Contractor may not release, disclose, disseminate, or publish this information to anyone other than the Government.

Contracting Officer’s Representative:

The Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract and will be specified at time of award.

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 Government may unilaterally change the COR designation at any time throughout the performance period of this contract.

ix. The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (Oct 2015) is applicable to this solicitation.

x. The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. The following is provided as an addendum to clause 52.212-2:

(a) 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, i.e. this RFQ will be evaluated and award made on the basis of best value to the Government. Offeror’s submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty and training considerations.

Technical evaluation shall be based on the following:

1. Technical Approach (70 points)

NIDA shall evaluate:

a. How the Offeror’s proposal addresses each area of the Statement of Work requirements in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them.

b. How the Offeror addresses its ability to prepare custom radiosynthesis of specific derivatives using either C11 or F18 within 2-3 weeks of submitted requests.

c. How the Offeror describes its ability to supply animals to NIDA Researchers to use in the experiments and house them for the duration of each experiment (length of time to be determined by NIDA researchers).

d. How the Offeror’s proposal demonstrates its ability to provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.

2. Past Performance (30 points)

a. NIDA will evaluate the Offeror’s demonstrated capabilities and past performance on a contract with similar requirements in the areas covered by the Statement of Work.

3. Mandatory Criteria:

• The Offeror’s facility shall be within a 2-mile radius of the NIDA IRP Facility located at:

251 Bayview Blvd., Suite 200, Baltimore, MD 21224

• Animal Welfare: The offeror must demonstrate its understanding and compliance with the

NIH Guide for Care and Use of Laboratory Animals. The Offeror shall submit evidence that its proposal was reviewed and approved by the Institution’s Animal Care and Use Committee (IACUC).

The award will be made on a competitive best value basis, using “tradeoff” among cost/price and non-cost/price factors. The Government may elect to award to other than the lowest priced offeror, or other than the offeror with the highest rated non-cost/price proposal. In either case, a tradeoff will be conducted. The government reserves such right of flexibility in conducting the evaluation as necessary to assure an award with the Contractor providing the best value to the government.

The major evaluation factors for this solicitation include technical and cost/price factors.

Interrelationships of these elements will be assessed consistent with the regulations concerning the considerations of cost and other factors in determining contract award.

Technical factors are of paramount consideration in the award of the contract, however cost/price is also important to the overall contract award decision. Therefore, offerors are reminded that award will be made to the offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government.

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

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

xi. The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition.

xii. The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

xiii. The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. See attachment.

xiv. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices:

1. Confidentiality and Nondisclosure of Information- Any information provided to the contractor

(and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

2. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

3. Care of Life Vertebrate Animals, HHSAR 352.270-5(b) (December 2015)

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C.

2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c)above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Note : The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email: ace@aphis.usda.gov ; Web site: ( http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare ).

(End of clause)

4. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated _____, which is incorporated by reference.

xv. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

xvi. 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. The Offeror's technical approach shall indicate compliance with the Scope of Work, and describe an essential understanding of the requirements involved in accomplishing the work. Please also include with your technical proposal sufficient information (including contract numbers, if applicable) to demonstrate performance of a contract with similar requirements to those outlined in the Scope of Work.

The total number of pages, (combination of technical approach and price quote) must not exceed 25 pages in length, excluding resumes. The Contractor shall submit its quote electronically.

A detailed work plan may be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical plan should reflect a clear understanding of the nature of the work being undertaken. The technical approach should include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks.

The technical plan shall include:

Technical Approach of how the work will be performed.

A milestones and time lines for the project, indicating the estimated period of performance for each task.

Facilities and /or resources used.

The price quote must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the ceiling price, as a Time and Materials type of purchase order is contemplated for this requirement. The proposal should include unit pricing for access to the small animal PET scanner, animals and their housing, and fully loaded labor hours for the production of radiotracers, along with any other required materials costs.

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 services (see section x. above).

Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of 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 Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), 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 September 6, 2018, 2:00 PM EST. Late responses will not be accepted. All responses must reference solicitation number NIHDA- 2018-00112. Responses must be submitted electronically to tracy.cain@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, please contact Tracy Cain by email at tracy.cain@nih.gov or by phone at 301-443-6677.

http://www.sam.gov/ mailto:tracy.cain@nih.gov

RFQ No. NIHDA-2018-00515 Attachment 1

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Custom Radiosynthesis of PET Ligands and Small Animal Imaging Experimentation

Statement of Need and Purpose:

The Intramural Research Program (IRP) of the National Institute on Drug Abuse (NIDA) Neuroimaging Research Branch (NRB) neuroscientists’ research requires in vivo imaging of the brain and its molecular processes in a way that parallels human imaging research. The purpose of this acquisition is to acquire a service contract to support the NIDA-IRP Biobehavioral Imaging and Molecular Neuropsychopharmacology Unit.

Background Information and Objective:

Positron Emission Tomography (PET) is a non-invasive imaging technique that enables picomolar detection (i.e. the highest sensitivity among all non-invasive imaging modalities available) of molecular processes in a living animal. PET compound radiosynthesis requires dedicated instrumentation and skillset which the NIDA-IRP does not have.

The objective of this contract is to: 1) prepare custom radiosynthesis of specific derivatives either with F18 or C11 on a weekly basis, 2) obtain an estimated 300 rats and/or mice (per contract year), 3) house said animals for the duration of the studies and 4) allow NIDA researchers to have access (approximately 10-50 hrs total per year) to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain. The custom radiotracers will be utilized in ongoing experiments of NRB’s Molecular Neuropsychopharmacology Unit. The objective is to synthesize several radiotracer derivatives, labeled with either F18 or C11 that will bind various targets. There is a specific need to have these PET tracers synthesized in close vicinity to NIDA-IRP so that we can have them available for immediate use in PET imaging experiments. Due to their half-life (110 minutes for F18- and 20 min for C11-labeled PET tracers) NIDA needs a facility to be within 2 miles of the NIDA-IRP so that the PET tracers can be quickly transported for immediate use.

Period of Performance:

The required period of performance is one year with two optional years.

• Base Year: 09/25/2018 through 09/24/2019

• Option Year 1: 09/25/2019 through 09/24/2020

• Option Year 2: 09/25/2020 through 09/24/2021

SCOPE OF WORK

General Requirements:

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:

Task 1: The Contractor shall prepare radiosynthesis, including custom radiosynthesis, of specific derivatives using either C11 or F18 or other radioisotopes, as requested by the Government.

Task 2: The Contractor shall supply animals (e.g. mice or rats) to NIDA Researchers to use in the experiments.

Task 3: The Contractor shall provide food and housing of the small animals for the duration of each experiment. It is estimated that animals will need housing for up to approximately 3 weeks.

Task 4: The Contractor shall provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.

Specific Requirements:

Specifically, the contractor shall:

For Task 1:

• Prepare routine and custom radiosynthesis compounds in accordance with the type, amount and required date of delivery of radiochemical specified in the Government’s request. The Government will give a lead time of at least 2-3 weeks estimated per request.

• Notify the Government when the synthesized ligands are available for use within five minutes of completing synthesis.

For Task 2:

• Provide the Government with rats or mice as specified by the Government (an estimated

300 animals per contract year) for use in experiments.

For Task 3:

• Provide housing to each animal for approximately up to 3 weeks. Animals will be requested by the Government by the amount, which will vary by experiment, and will be specified at the time of the request.

For Task 4:

• Provide NIDA researchers with access to a small animal PET scanner during the period of performance (an estimated 50 hours required per contract year).

• Provide all electronic data files produced from the PET scans to the Government within twenty-four hours after scanning is complete.

ESTIMATED EFFORT:

It is estimated that the effort required for full performance of this contract would be one (1) part time radiochemist (between 520-1250 hours is estimated), not including effort incidental to animal procurement and care.

OPTION QUANTITIES:

Option Quantity 1: (12 units available per contract year)

As required for the work described under Tasks 1-4, the Contractor shall provide additional labor and materials up to a ceiling of $5,000 per unit.

GOVERNMENT RESPONSIBILITIES

The Government will send specific requests detailing the type and amount of radiochemical required (e.g. in mCi) and will include the requested delivery date.

The Government will also request the number of rats or mice needed at separate timepoints throughout the period of performance. The number and type of animal will vary by experiment and will be specified at the time of each request but it is estimated that approximately 300 total rodents will be required per contract year.

DELIVERY OR DELIVERABLES

Deliverables will include rats or mice, as specified by the Government, and housing for up to approximately 3 weeks per animal. Animals should arrive at the facility within one to two weeks of placing the order.

The radiotracers themselves are deliverables as are all electronic data files which correspond to the PET scanned animals (scan files such as list, sonogram and img files). These should be provided to the Government within twenty-four hours of scanning. Additionally, all other information regarding dose administration and animal information should also be provided within the same time frame.

REPORTING REQUIREMENTS

No formal reports will be required, but all electronic data files which correspond to the PET scanned animals (scan files such as list, sinogram and img files) will be required for each scan.

Key Personnel:

A radiochemist is required for the synthesis of radiotracers.

KEY PERSONNEL, HHSAR 352.237-75 (December 2015) 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 (including, when applicable, Human Subjects Testing requirements). 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.

Data Rights:

NIDA IRP shall have unlimited rights to and ownership of all deliverables provided under this purchase order. 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,” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The Contractor is required to develop and provide to the Government all electronic data files and storage for these files which correspond to the PET scanned animals (scan files such as listmode, sinogram and img files) will be required for each scan. No public facing data or reports will be provided by the Contractor.

Publications and Publicity:

Not Applicable

Confidentiality of Information:

All electronic data files and storage for these files which correspond to the PET scanned animals (scan files such as list, sonogram and img files) are to be considered confidential and property of the Government and the Contractor may not release, disclose, disseminate, or publish this information to anyone other than the Government.

FAR CLAUSE 52.212-4

CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (JANUARY 2017)

(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 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.

RFQ No. NIHDA-2018-00515 Attachment 2 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113304 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137572

(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.

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(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

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(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 32.608-2 of the Federal Acquisition Regulation 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.

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(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.

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(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; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 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) System for Award Management (SAM).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)(i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to (A) change the name in the SAM database; (B) comply with the requirements of subpart 42.12; and (C) agree in writing to the timeline and procedures

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(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the SAM information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the SAM database.