Revised_Solicitation_17-223-SOL-00112.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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 written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13.5. The solicitation number is 17-223-SOL-00112.

This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2005-94 and 2005-95, dated January 19, 2017. This requirement is Full and Open Competition.

The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. This requirement full and open competition.

Schedule of Supplies or Services and Prices/Costs (inclusive of delivery, installation, and on-site training) CLIN Description Qty Unit Unit Price Extended Price

1 Confocal Imaging System and Components

1 Ea

2 Option Year 1: Post Warranty Service/Maintenance Agreement for Confocal Imaging System

12 Mo

3 Option Year 2: Post Warranty Service/Maintenance Agreement for Confocal Imaging System

12 Mo

Total Amount

Statement of Work (SOW)

Background

The Microscopy and Imaging Core Facility of Center for Biologics Evaluation and Research (CBER) supports all the Food and Drug Administration (FDA) scientists and laboratories for their morphological studies and microscopic imaging. The Microscopy and Imaging Core Facility works are analyzing the host – pathogen (e.g. virus, bacteria, parasites) interaction using cultured cell and tissue in immunological responses and vaccine related studies.

Due to the demands of handling many fluorescence samples at the same time to obtain the details of morphological changes are the most challenging for microscopy but critical. Recent advances of robotics and automation technologies combined with dual spinning disk confocal microscopic technology enable us to handle and visualize vast amount of lively stained multi-color samples on multiwall plate such as 96, 384 and 1536 multi-well plates with high speed and high resolution. The technique called High Content Analysis (HCA) is becoming more standard for many imaging core facilities. HCA is an emerging technology that is being used as a scientific tool in our research program. Conventional manual confocal microscopy for HCA is slow process and is time & man-power dependent. High Content Analysis became standard for examining vast number of biological samples to compare/determine the efficacy of vaccine, biologics or drug candidates and strong advantage for core facility.

Scope

Our objective is to obtain a Confocal Imaging system in order to continue acquire high content microscopic image data from live or fixed cell, tissue that are important to the research and CBER review program. The system will also help core user’s many samples and benefit to reduce the equipment waiting time.

General Requirement

1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

2. The instrument shall be warranted for parts and labor from date of installation acceptance.

All warranty work shall be performed on-site at CBER, i.e., returning the equipment to the manufacturer is unacceptable.

3. The system shall be delivered with all components, accessories, start-up supplies required for installation and start-up., i.e., a turn-key solution.

4. The Contractor shall provide on-site (Government-site) operator familiarization training of the system upon completion of installation. Such familiarization shall include system operations, optimization, and basic preventive maintenance procedures.

5. The Contractor shall include all parts, travel, and labor to complete installation.

Installation shall be performed and completed during normal duty hours (Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time).

Technical Requirement

At a minimum, the system shall meet the following requirement:

1. The system shall have the abilities of the fully automated confocal and wide field fluorescence imaging as well as phase contrast and bright field image acquisition with high resolution, high sensitivity and high speed imaging system with efficient multicolor image acquisition for cultured live or fixed cell, tissue on 6, 12, 24, 48, 96, 384 and 1536 multi-well plates.

2. The system shall have wide-view micro-lens enhanced dual spinning disk based confocal scan head for high resolution, high speed scanning and less photo toxicity/photo- bleaching of live cell image acquisition.

3. The system shall be equipped with 405, 488, 561 and 640 nm lasers with Halogen lamp for confocal, phase contrast and bright field imaging.

4. The system shall have two large format 16 bit sCMOS cameras which have - 40C cooled,

5.5 mega pixels (2560x2160 pixel), 6.5 um pixel size for simultaneous high speed, high sensitive simultaneous fluorescence and light image acquisition.

5. The system shall have 4x, 10x, long working distance 20x, 40x dry objective lenses and 60x (NA1.2) water objective lens. Shall have 20x phase lens objective lens for phase image acquisition.

6. The system shall have stage incubator to provide temperature CO2 and humidity control for long time-lapse (maximum for 3 day) experiment.

7. The system shall have both laser-based and image based autofocus for high speed reliable image acquisition.

8. The plate holder shall be able to be control for temperature between 27- 40C and CO2 control between 5-10 % using gas mixer from compressed air and CO2 lines as well as humidity control (75-85% Humidity) for maximum of 3 day culture. The objective heater shall be provided for system drift suppression.

9. The system shall have automated x-y stage with 1um precision and high speed 6, 12, 24, 48, 96, 384 and 1536 multi-wells for virus titration, doze dependency and time course assay and application.

10. The system shall have Z axis control to acquire 3D(xyz) imaging data from up to 100 um thick, multiple tissue samples and stitching capability.

11. The imaging speed shall be 1 min for 3 color image acquisition for 96 well plate and 5 min for 3 color 384 wells for 1 field of view.

12. The system shall have incubated heated stage control between 35-40 C with CO2 and humidity controls for live cell and tissue sample handling up to 3 days.

13. 60x Water objective lens shall have auto water supply and aspiration module, which have safe guard function for any water spills.

14. The system shall have cell search functions to detect minimum number of cells and cell counting.

15. The system shall provide a live view of current view area, to give flexibility to check our experimental condition.

16. The system shall include 10-100ul solution dispensing pipettor for 96 and 384 well plate setup. This system shall be built-in during the image acquisition for kinetic assay for biologics, vaccine and drug evaluation.

17. The system shall maximum speed of 35 frame per second to capture high speed event in live cells.

18. The system shall have cell and particle tracking function for time lapse experiment.

19. The system shall have emission filters for fluorescence acquisition for Hoechst/DAPI, GFP, Cy3, Texas Red, mcherry, alexa 555, alexa 568, alexa 594, alexa 647.

20. The system shall have software controlled searching function using low magnification objective lens (such as 4x) for finding research of interest (ROI). After define ROIs, the system shall be able to re-image the ROI with high magnification objective lens such as 40x dry lens or 60x water lens to obtain high resolution images. This process shall apply for all wells from multi-well plates.

21. The system shall have the flexibility of imaging setup control for objective lens, channels, exposure time and laser power control, field selection and z-stack available for individual well.

22. The system shall have bright field imaging detector to visualize morphological image from various biological specimen.

23. The system shall have the ability to track/visualize both very fast and slow movement of particles, such as fluorescently labeled peptide or viral particles and ability for flexible /variable scan speed (max 40fps).

24. The system shall be able to handle multiple, simultaneous imaging protocols for fully control of exposure, color, binning, time lapse setting , z-axis, lens, field of view for every wells on the plate.

25. The system shall have image analysis software package.

26. The system shall include built in anti-vibration module, which can minimize any vibration from environment.

27. The system shall be robot friendly and shall be flexible for wide range of plate loading robotics system.

28. The system shall be field upgradable for future camera upgrades and light path.

29. The system shall include data analysis workstation and software to handle vast amount of image data handling, visualization and analysis.

30. The system shall include updates and upgrades for 12 months from date of installation.

31. Access to technical support via email or telephone for 12 months from date of installation.

Two (2) Year Post Warranty Option Periods Minimum Service Agreement Requirements for Option Items 2 and 3:

•Shall include one (1) planned preventative maintenance visit per contract year.

•Shall include unlimited corrective/remedial maintenance, service and repairs shall include all labor, travel, and parts (except consumables). Provide service response time with quote.

•Unlimited technical support during the Contractor’s normal operating hours. Initial response within 24 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.).

•Shall include unlimited software and firmware updates.

•All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

•Access by the FDA personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide high level of expertise for troubleshooting the instrument.

•All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Deliverables: Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

Period of Performance:

FOB Point Destination: Delivery/Installation is within ninety (90) calendar days after receipt of contract award. Up to a maximum of two (2) 1-year periods of optional maintenance follow the end of the warranty period tentatively as follows (based on an award not later than date of 29 Sep 2017, delivery/installation/training not later than 28 Dec 2017, and 1-year warranty period of 29 Dec 2017–28 Dec 2018; all dates subject to change based on actual date of award and system acceptance):

Option Year 1: 29 Dec 2018–28 Dec 2019 Option Year 2: 29 Dec 2019–28 Dec 2020

Delivery Address:

White Oak Campus Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Bldg 52/72, Room 1233 Silver Spring, MD 20993 POC (To be provided at time of award)

Repairs and Preventative Maintenance visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal holidays are as follows:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Contract Type: Commercial Item-Firm Fixed Price

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (JAN 2017) applies to this solicitation. The following addenda apply:

It is the offeror's responsibility to monitor FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc.

Paragraph (b). The government is not responsible for locating or securing any information, which is not identified in the quote.

Technical acceptability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the supplies and service/maintenance agreement offered conforms to the solicitation. Offerors shall specifically address each technical requirement stated above to demonstrate that the proposal meets the technical requirements. Offerors may provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.

The price proposed shall represent the offeror’s response to the schedule of supplies/services above. The post warranty service/maintenance agreement option periods will not be funded at time of award. If exercised, funding will be obligated individually each option period year via contract modification.

Subcontracting Plan - Large Business: Pursuant to FAR Clause 52.219-9, and as otherwise set forth herein, the Offeror shall submit with its proposal, a small business subcontracting plan containing at a minimum the content required by FAR Clause 52.219-9(d) and using the Attachment 1, Small Business Subcontracting Plan template attached to this solicitation. If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Failure to submit and then negotiate an acceptable subcontracting plan within 5 calendar days of the date the Contracting Officer notifies the offeror of issues and concerns with the subcontracting plan will render the offeror ineligible for award. The resulting subcontracting plan will be a made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(l). Small business firms are exempt from this requirement.

Include the firm’s DUNS number with quote.

Addendum to Paragraph (b)(8). Representations and Certifications - In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's proposal shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222- 48.

Note: This solicitation is being issued under the premise that the Contractor will certify that the service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 and FAR 222.1003-4(c). If this is the case and the Contractor certifies that it is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41 and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 15-4269 (Rev.-3) (first posted on 08/01/2017) https://www.wdol.gov/wdol/scafiles/std/15-4269.txt?v=3

52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification. (MAY 2014)

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror ______does _____ does not certify that-

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An “established market price” is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Labor Standards statute-

(1) Will not apply to this offeror, then the Service Contract Labor Standards clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision—

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements, will not be included in any resultant contract awarded to this offeror; and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

(End of provision)

The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation.

The Government will award a contract resulting from the RFQ to the responsible party whose quote conforming to the RFQ offers the best value to the Government, price and other factors considered. For the purposes of this RFQ best value is defined as lowest price technically acceptable.

Proposals will first be ranked from lowest to highest total price. The lowest price proposal shall then be evaluated regarding technical acceptability. If determined technically acceptable and the price is reasonable an award will be made to that offeror. If however the lowest priced offer is determined technically unacceptable the next lowest price proposal shall be evaluated regarding technical acceptability. This process will continue until a technically acceptable proposal is found.

(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.

(End of provision)

52.212-3 Offeror Representations and Certifications-Commercial Items (Jan 2017) applies to this acquisition.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

(a) Definitions. As used in this provision— “Administrative merits determination” means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B.

in the DOL Guidance.

“Arbitral award or decision” means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Civil judgment” means–

(1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction.

(2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“DOL Guidance” means the Department of Labor (DOL) Guidance entitled: “Guidance for Executive Order 13673, ‘Fair Pay and Safe Workplaces’”. The DOL Guidance was initially published in the Federal Register on August 25, 2016, and significant revisions will be published for public comment in the Federal Register. The DOL Guidance and subsequent versions can be obtained from www.dol.gov/fairpayandsafeworkplaces.

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Enforcement agency” means any agency granted authority to enforce the Federal labor laws.

It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13673 are–

(1) Department of Labor Wage and Hour Division (WHD) for–

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for–

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for–

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans’ Readjustment Assistance Act of 1972 and the Vietnam Era Veterans’ Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for–

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service—

(6) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(7) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following:

ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Labor compliance agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor laws” means the following labor laws and E.O.s:

(1) The Fair Labor Standards Act.

(2) The Occupational Safety and Health Act (OSHA) of 1970.

(3) The Migrant and Seasonal Agricultural Worker Protection Act.

(4) The National Labor Relations Act.

(5) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6) 41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8) Section 503 of the Rehabilitation Act of 1973.

(9) The Vietnam Era Veterans’ Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974.

(10) The Family and Medical Leave Act.

(11) Title VII of the Civil Rights Act of 1964.

(12) The Americans with Disabilities Act of 1990.

(13) The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education;

or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women;

and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program” (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

Note to paragraph (a): By a court order issued on October 24, 2016, the following definitions in this paragraph (a) are enjoined indefinitely as of the date of the order: “Administrative merits determination”, “Arbitral award or decision”, paragraph (2) of “Civil judgment”, “DOL Guidance”, “Enforcement agency”, “Labor compliance agreement”, “Labor laws”, and “Labor law decision”. The enjoined definitions will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs [Offeror to identify the applicable paragraphs at (c) through (t) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it is, is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it is, is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it is, is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it is, is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it is, is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It is, is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It is, is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It is, is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It is, is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture:

__________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that—

(i) It is, is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business

Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It is, is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order 11246—

(1) Previous contracts and compliance. The offeror represents that—

(i) It has, has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It has, has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that—

(i) It has developed and has on file, has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 cfr parts 60-1 and 60-2), or

(ii) It has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352).

(Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American—Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Supplies.”

(2) Foreign End Products:

Line Item No. Country of Origin [List as necessary]

(3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(g)(1) Buy American—Free Trade Agreements—Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” “Free Trade

Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements–Israeli Trade Act.”

(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

Line Item No. Country of Origin [List as necessary]

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act.” The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.”

Other Foreign End Products:

Line Item No. Country of Origin [List as necessary]

(iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(2) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Canadian End Products:

Line Item No.

[List as necessary]

(3) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Canadian or Israeli End Products:

Line Item No. Country of Origin [List as necessary]

(4) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

Line Item No. Country of Origin [List as necessary]

(5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.-made…