36C25719Q0395-000.docx

36C25719Q0395 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

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POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 North Texas VA Health Care System PET Radiopharmaceuticals 79720 36C25719Q0395 03-21-2019 N 325412 Department of Veterans Affairs Contracting Section (90C) 707 East 3rd Street Big Spring TX 79720 Department of Veterans Affairs North Texas VA Health Care System Nuclear Medicine Service 4500 S. Lancaster Rd.

Dallas, TX 79720

USA

SECTION A - CONTRACT REQUIREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format specified in the Federal Acquisition Regulation Subpart 12.6, as supplemented with additional information included with this notice. This announcement constitutes the only publication; quotations are being requested and a written solicitation will not be issued. The Department of Veterans Affairs, Veterans Health Administration, North Texas VA Health Care System requires PET Radiopharmaceuticals.

This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular 2019-01, effective 01/22/2019. The solicitation number is 36C25719Q0395, and is issued as a Request for Quote (RFQ). This acquisition is set-aside 100% for Small Business in accordance with FAR 19. The North American Industry Classification Code (NAICS) is 325412 – Pharmaceuticals Preparation Manufacturing, with a small business size standard of 1,250 Employees. The delivery period will become effective 04/01/2019 or upon award.

The government intends to award a Blanket Purchase Agreement (BPA), in accordance with FAR Parts 12 & 13, and subject to the provisions and clauses listed in the VA solicitation format as follows. Please refer to those pages for specifications and points of contact.

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

549-19-3-068-0016 36C25719Q0395 03-14-2019 Jessica Roman 432-268-5055 03-21-2019 4:00 pm 00519 Department of Veterans Affairs Contracting Section (90C) 707 East 3rd Street Big Spring TX 79720 X X 325412 1250 Employees N/A X 00519 Department of Veterans Affairs North Texas VA Health Care System Nuclear Medicine Service 4500 S, Lancaster Rd.

Dallas TX 75216-7167 00519 Department of Veterans Affairs Contracting Section (90C) 707 East 3rd Street Big Spring TX 79720

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices

(877) 353-9791

(512) 460-5540 See CONTINUATION Page See Price/Cost Schedule See CONTINUATION Page 549-3690160-068-822900-2631-010022900 X X Michael J. Tusinger Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 Department of Veterans Affairs Contracting Section (90C)

707 East 3rd Street Big Spring TX 79720

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Instructions to Offerors Evaluation Factors for Award

Solicitation issued as a small business set-aside under NAICS code 325412. Please note that the Small Business Administration (SBA) Non-Manufacturer Rule applies to this acquisition. All items shall be manufactured by a small business, within the United States.

Quotations due 03/21/2019 at 4:00 p.m. EST (3:00 p.m. CST).

Submit quotations via e-mail to jessica.roman@va.gov. Confirmation of receipt is recommended.

Point of Contact:

Jessica Roman Contract Specialist SAO West Network Contracting Office (NCO) 17 707 East 3rd Street Big Spring, TX 79720 Phone: 432-268-5055 Fax: 432-517-4586 jessica.roman@va.gov

Late quotes and/or documentation will not be accepted. All questions, comments, or inquiries are to be submitted in writing to the Point of Contact, referenced above, prior to the closing of the solicitation.

CONTRACTORS READ FIRST

I. Basis of Award The Government will award a delivery order resulting from this solicitation to the responsible offeror whose quote, meeting all salient characteristics/requirements outlined in the solicitation, represents the lowest price.

Past performance will be assessed with a “pass/fail” evaluation based upon information supplied by the contractor or other sources available to the government. Contractor will receive a “pass” rating if their past performance is determined to be satisfactory or better. Contractors with no relevant performance history or for whom information on past performance is not available will receive a neutral rating. A neutral rating will be evaluated as a “pass” for the purposes of determining responsibility.

The following areas will be evaluated:

Factor 1: Price – Contractors shall complete the Price/Cost Schedule. The schedule may be altered, or an alternate schedule used where appropriate in order to express quote detail. The contractor shall provide information clearly demonstrating the quote meets all requirements outlined in the solicitation.

Factor 2: Past Performance – The Contracting Officer (CO) will refer to the Past Performance Information Retrieval System (PPIRS) when evaluating past performance. The contractor may choose to submit addition past performance references with company/firm name, telephone number, and e-mail address.

Deliverables:

· The contractor shall submit with quote copies of all relevant licenses and certifications related to the manufacture/distribution/transportation of radiopharmaceuticals.

· The contractor shall complete all fill-ins required in the Statement of Need below:

Statement of Work

1. SCOPE

The North Texas VA Health Care System (NTVHCS), Nuclear Medicine Service (NMS), requires the purchase of PET Radiopharmaceuticals. The acquisition will be conducted pursuant to FAR Parts 12 – Acquisition of Commercial Items, and 13 – Simplified Acquisition Procedures. Quotes will be evaluated based upon price and past performance methodology. The solicitation is anticipated to result in a single-award Blanket Purchase Agreement (BPA), with a delivery period of a Base Year, and up to four (4) Option Periods of one-year each. The VA may award a multiple-award BPA per drug, if determined to be in the VA’s best interest by the Contracting Officer (CO).

This solicitation is issued as a small business set-aside under NAICS code 325412. Please note that the Small Business Administration (SBA) Non-Manufacturer Rule applies to this acquisition. All items shall be manufactured by a small business, within the United States.

2. GENERAL REQUIREMENTS

a. The contractor shall be licensed by the US Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee), and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals shall be shipped from the Licensee directly to NTVHCS.

b. The contractor shall provide copies of all relevant licenses, certifications, and/or partnering agreement(s), along with their quote.

c. The contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals.

d. The contractor/licensee shall be able to provide PET radiopharmaceuticals to the NTVHCS NMS PET Imaging Facility at the Dallas VA Medical Center; additional delivery locations include: Sam Rayburn Memorial Veterans Center, VA Fort Worth Outpatient Clinic, Tyler VA Community Based Out-patient Clinic (CBOC), and Plano CBOC, as needed for mobile PET Services, and any future additional leased or owned NTVHCS location. Exact addresses subject to change. The additional delivery locations will not be active upon award, but may become active during the course of the BPA via modification.

e. The contractor/licensee shall have available an adequate supply of required products to meet the requirements of the NTVHCS with proof of contingency supply chain to prevent disruption of clinical care.

f. The contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. The contractor shall supply each NTVHCS facility with a bar code reader or comparable VA approved device that is compatible with the NTVHCS Nuclear Medicine Information System (NMIS), or provide approved infrastructure/Nuclear Medicine Information System with inter-facility connectivity to meet this requirement. The contractor shall support any necessary steps to ensure approval for use of new infrastructure (Example: Information Security) upon award, and prior to start of the contract. For infrastructure change that may delay BPA start, the contractor must specify in detail alternative procedures and necessary contingency, which must be in compliance with listed requirements and be mutually acceptable.

g. If the contractor's/licensee’s system varies from the NVTHCS facility NMIS, the contractor shall provide a means for compatibility or an alternative system with any needed data migration, technical support, and training for staff on its use at no additional charge to the VA. Any additional tracking system(s) provided shall comply with all VA and associated Information Technology (IT), as well as information security, requirements [see above]. Any provided system shall adequately, and securely, link the different listed VA sites of NMS operations.

h. All packages containing radioactive material shall be labeled and shipped in accordance with Title 49, Code of Federal Regulations Parts 172 and 173.

i. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

j. The contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results shall be furnished to NTVHCS Chief of Nuclear Medicine and CO upon request.

k. The contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only:

a. By-product material or cyclotron produced materials manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State.

b. Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use

l. The contractor shall utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care or IRB approved research.

m. The contractor/licensee shall deliver radioisotope in an amount greater than or equal to the activity ordered with calibration for the specified appointment time so that patient administered quantity is within regulatory limits of the prescribed dose. Failure to meet this requirement will result in the VA to receive dose compensation that is separate from any returned dose quantities. Greater than 10 such instances within a year duration of the BPA may result in penalties and/or BPA termination.

n. All routine radiopharmaceutical dose deliveries shall occur >60 minutes prior to the calibration time. F18-NaF doses shall be made available a minimum of three (3) days per week; however, contractors able to provide this tracer five (5) days per week are preferred. The latest first F18-NaF dose calibration time shall be no later than 9:00 a.m., Monday through Friday.

o. The contractor/licensee shall provide at least two (2) scheduled deliveries of radiopharmaceutical per day. Note that the NTVHCS PET Facility in Dallas provides both inpatient and outpatient care, and is the tertiary VA Medical Center for the North Texas area. Additional radiopharmaceutical delivery may be required based upon clinical schedule, including emergency/STAT deliveries, at no additional charge. STAT delivery times during normal working hours should not exceed sixty (60) minutes from time the order is placed during normal working hours, and ninety (90) minutes afterhours and holidays.

3. DELIVERABLES

All annual quantities are estimates, the contractor will be paid for items delivered; no minimum order is guaranteed. The below listed items are required:

REQUIRED DRUGS

Contractors are encouraged to list any additional optional items they are able to provide, including new to the market products, specialty radiotracers, and radiotracers that may provide a contingency source for other NMS modalities. Contractors will NOT receive evaluation credit for additional items listed, nor with additional item pricing be evaluated. It shall remain within the scope of this BPA to add optional items at a later date during delivery period. Table of optional tests below:

4. NORMAL/ROUTINE ORDERING

a. Routine orders shall be placed by authorized VA personnel during normal working hours throughout the workday. Each day, first delivery shall be received between 6:30 a.m. local time and 7:00 a.m. local time, but no later than 7:00 a.m. via direct delivery to the NTVHCS NMS PET Radiopharmacy. The contractor/licensee will be furnished the name(s) of VA personnel that are authorized to place orders, and will provide appropriate personnel and contact information for staff receiving orders, able to offer technical or administrative support, as well as staff involved in radiopharmaceutical delivery in accordance with VA Radiation Safety Office requirements.

b. Completed background clearance checks shall be submitted for review to NTVHCS NMS/Radiation Safety Office for all delivery personnel following award and prior to start of performance. Notification is required for any changes to these records, which should be made available for audit when requested by the Chief of NMS.

c. Orders shall only be placed by authorized VA personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication process such as confirmation e-mails is preferred.

5. NORMAL/ROUTINE DELIVERY

a. Depending upon changing Medical Center/Facility patient care requirements, the contractor/licensee may be required to provide routine delivery and pick-up, multiple times (>2 times) throughout the day. Delivery orders, or the electronic ordering system, shall include the following information:

i. Delivered item(s) and quantities,

ii. Date & time of delivery,

iii. Applicable VA obligation numbers.

b. Contractors with secure online ordering portal, or that utilizes a VA approved Information Security system that allows ordering which includes Protected Health Information (PHI) to better protect patient safety is preferred. Upon award, contractor will take necessary steps to ensure any needed infrastructure is in place prior to start of the contract.

c. The contractor is responsible for on-time delivery of radiopharmaceutical and shall maintain back-up facilities/production options available to maintain greater than 99% on-time delivery (per invoice cycle) or risk penalty that includes no charge doses that, at a minimum, equal to the number of missed doses and 10% discount for that invoice. All cancelled PET or PET/CT scans due to contractor delayed delivery will be the responsibility of the contractor and the returned dose will not count towards the allotted 10% of available returns due to patient no show or cancellation.

d. It is incumbent upon the contractor to ensure delivery personnel are adequately familiar with each specific delivery location. Delivery personnel will park at the nearest secure location and proceed directly to the NMS site where they will be escorted to the radiopharmacy by VA staff.

6. SAME-DAY DELIVERY/STAT ORDERS

The contractor/licensee shall provide STAT radiopharmaceuticals in accordance with the schedule of supplies, and with no associated delivery or STAT fees when needed. STAT deliveries during normal working hours will occur within sixty (60) minutes from time the order is placed during normal working hours, and ninety (90) minutes afterhours and holidays. For weekend and holiday deliveries direct contact with NTVHCS Nuclear Medicine staff is required to ensure safe, secure, appropriately escorted radiopharmaceutical delivery.

Same-Day Add-on Delivery of routine non-Emergent radiopharmaceutical can be received at NTVHCS facilities up to ninety (90) minutes after the order is placed during normal working hours if approved by NTVHCS Chief of Nuclear Medicine. NMS normal working hours are listed below.

7. NORMAL WORKING HOURS AND ACCESS TO SITE

a. Normal working hours between Monday and Friday, 7:00 a.m. and 4:30 p.m., local time, and Saturday, 7:00 a.m. – 11:00 a.m. local time, excluding Federal Holidays.

Legal Holidays Observed: New Year’s Day – 01 January Martin Luther King’s Birthday – Third Monday in January President’s Day – Third Monday in February Memorial Day – Last Monday in May Independence Day – 04 July Labor Day – First Monday in September Columbus Day – Second Monday in October Veterans Day – 11 November Thanksgiving Day – Fourth Thursday in November Christmas – 25 December *Please note that holidays falling on Saturday will be observed on the preceding Friday; holidays falling on Sunday will be observed on the following Monday.

b. Access to a NTVHCS PET radiopharmacy, during non-working hours, shall be obtained by contacting designated on-call Nuclear Medicine personnel. VA Police Service may be called to assist with escort in certain circumstances; however, the primary point of contact will be Nuclear Medicine staff. Delivery personnel must be escorted at all times within facility ‘Controlled Areas’/NMS, as per TJC and NRC/regulatory requirements.

c. The contractor/licensee will provide updated lists of delivery personnel who will sign in/sign out with NVTHCS NMS staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at NTVHCS facilities/NMS. Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is required.

d. Upon request by NTVHCS/Radiation Safety Officer, the contractor shall provide a copy/reports of contractor’s/licensee’s RSO Safety Audits of Federal Compliance.

8. ORDERING CONTACT INFORMATION

The contractor/licensee shall provide contact information for the placement of orders, see required information below:

POC Name:

Address:

City/State/Zip Code:

Ordering Phone Number:

Ordering Fax Number:

Ordering E-Mail Address:

9. DELIVERY COMMITMENT

The time of delivery specified, or mutually agreed upon, at the time of receipt of telephone/electronic order(s) shall become mandatory upon the contractor's/licensee’s acceptance to the commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by the Ordering Personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of BPA in accordance with the provisions for default. The Government may terminate this BPA in whole or in part if the contractor fails to meet the required delivery schedule.

10. DELIVERY LOCATION/PERIOD

Delivery shall be made to:

North Texas VA Health Care System (NTVHCS) (Dallas VAMC) Nuclear Medicine Service (115) PET Imaging Center 3rd Floor, Room 3B-672E 4500 S. Lancaster Road Dallas, TX 75216

FOB Destination

Additional delivery location maybe be defined by VA authorized personnel.

a. Additional delivery locations may become active during the delivery period through modification, these location addresses are listed below:

i. Sam Rayburn Memorial Veterans Center 1201 E. 9th St.

Bonham, TX 75418

ii. Fort Worth Outpatient Clinic 2201 Southeast Loop 820 Fort Worth, TX 76119

iii. Tyler CBOC 7916 South Broadway Ave., Suite 100 Tyler, TX 75703

iv. Plano CBOC 3804 15th Street, Suite 175 Plano, TX 75075

11. DELIVERY PERIOD

The VA anticipates the following delivery period, to begin 04/01/2019, or upon award:

Contractors may quote on one, multiple, or all delivery periods. All quoted delivery periods will be evaluated. Contractors must quote all three (3) Required Drugs as listed above.

12. CONTINUED EDUCATION

The contractor shall provide NTVHCS NMS personnel access to relevant online and/or live Initial, as well as Continuing, Education at no cost to NTVHCS to ensure staff are trained and remain current in safe receipt and handling of radioactive materials/radiopharmaceuticals, correct use of infrastructure applications such as an online ordering portal/NMIS, as well as any related regulatory requirements (Example: DOT).

13. RADIOPHARMACEUTICAL RETURN CREDIT

a. Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or surcharges. A tiered pricing structure with lower cost per increased quantity used is preferred. The VA shall be allowed a minimum 10% radioisotope return for all contracted radiopharmaceuticals due to patient cancellation, no show, and/or rescheduling, at no charge. In addition, the contractor shall accept returns for full credit toward future orders under the following conditions:

i. Product(s) ordered or shipped in error,

ii. Product(s) damaged in shipment,

iii. Concealed shipping damages,

iv. Recalled product(s), or

v. Outdated products in unopened, original container.

14. GOVERNMENT FRURNISHED PROPERTY

There will be no Government Furnished Property provided to the contractor in the performance of this contract.

15. INVOICE INFORMATION

a. The contractor shall submit all invoices in arrears.

b. Invoices shall be submitted electronically online at: http://www.fsc.va.gov/einvoice.asp.

c. Payment will be made by VA FSC, Austin, Texas 30 days after receipt of a proper invoice.

d. General information to include on invoices:

i. Submission of a proper invoice including facility name, address, and phone number.

ii. Type of service performed.

iii. Date(s) of service.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

F18 FDG Unit Dose up to 10 mCi per dose Contract Period: Base POP Begin:

POP End:

F18 NaF Unit Dose up to 10 mCi per dose

F18 FDG additional mCi >10 mCi

F18 FDG Unit Dose up to 10 mCi per dose Contract Period: Option 1

F18 NaF Unit Dose up to 10 mCi per dose

F18 FDG additional mCi >10 mCi

F18 FDG Unit Dose up to 10 mCi per dose Contract Period: Option 2

F18 NaF Unit Dose up to 10 mCi per dose

F18 FDG additional mCi >10 mCi

F18 FDG Unit Dose up to 10 mCi per dose Contract Period: Option 3

F18 NaF Unit Dose up to 10 mCi per dose

F18 FDG additional mCi >10 mCi

F18 FDG Unit Dose up to 10 mCi per dose Contract Period: Option 4

F18 NaF Unit Dose up to 10 mCi per dose

F18 FDG additional mCi >10 mCi

B.3 DELIVERY SCHEDULE

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Nuclear Medicine Service (115) 4500 S Lancaster Rd.

Dallas, TX 75216

USA

Page 1 of Page 1 of Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[X] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

[] (ii) Alternate I (NOV 2011) of 52.219-3.

[] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (JAN 2011) of 52.219-4.

[] (13) [Reserved] [x] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[] (ii) Alternate I (NOV 2011).

[] (iii) Alternate II (NOV 2011).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

[] (ii) Alternate I (Oct 1995) of 52.219-7.

[] (iii) Alternate II (Mar 2004) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JAN 2017) of 52.219-9.

[] (v) Alternate IV (AUG 2018) of 52.219-9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).

[X] (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)).

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15 U.S.C. 637(m)).

[X] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[x] (26) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2018) (E.O. 13126).

[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (28)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

[X] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b).

[] (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [] (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[x] (46) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83).

[] (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I (MAY 2014) of 52.225-3.

[] (iii) Alternate II (MAY 2014) of 52.225-3.

[] (iv) Alternate III (MAY 2014) of 52.225-3.

[] (48) 52.225–5, Trade Agreements (AUG 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[x] (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (50) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[] (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[] (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (54) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

[] (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (57) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (58) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).

[] (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[] (ii) Alternate I (Apr 2003) of 52.247-64.

[] (iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).

[] (2) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

[] (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

[] (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(iv) 52.219–8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

(v) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiii)(A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (OCT 2015) (E. O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

(xviii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)