36C24722Q0014_1.docx

36C24722Q0014

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

534-21-4-062-0023 36C24722Q0014 09-22-2021 Darius Crane

(843) 789-6528 10-04-2021 16:00

EDT

Darius Crane Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston

SC

29403-5799 X 325412 1250 Employees N/A X See Delivery Schedule

Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston

SC

29403-5799

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page Provide Radiopharmaceutical Isotopes for delivery as needed to the Ralph H. Johnson VA Medical Center, Charleston, SC 29401.

See Price/Cost Schedule for item descriptions and estimated quantities.

POP: Base Year and 4 Option Years to begin 10/19/2021.

Offerors are to complete Schedule/Price in Excel format to include Base Year and all Option Years.

Offeror must complete boxes 30 a-c as acknowledgement of offer.

See CONTINUATION Page X 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 36C247 Darius Crane Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

STATEMENT OF WORK

RADIOPHARMACEUTICAL AND NON-RADIO PHARMACEUTICAL ITEMS

The Ralph H. Johnson VA Medical Center requires delivery of Radiopharmaceutical and Non-Radio Pharmaceutical Items unit doses in order to perform a variety of Nuclear Medicine diagnostic procedures. The twenty-four (24) hours shelf life of Radiopharmaceutical prevents stocking and storing. Radiopharmaceutical unit doses cannot be ordered prior to twenty-four (24) hours of a patient treatment; therefore, on-time daily delivery is vital to patient care. Requests will be placed daily, if required, for next day delivery during normal working hours of 7:00 am – 5:00 pm Monday through Friday excluding Federal Holidays, consisting of:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contractor shall provide all labor, supervision, and transportation necessary to meet the twenty-four (24) hours delivery for normal daily unit does and three (3) hours for emergency deliveries.

Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of Radiopharmaceuticals may vary based on patient demand.

It is understood that the contractor must perform the services based, in part, on information furnished by the Ralph H. Johnson VA Medical Center; however, the contractor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor’s services in utilizing the results of such services. Contractor shall perform these services with a standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services.

CAPABILITY OR PERFORMANCE: Manufacturing of radiopharmaceutical isotopes requires pharmaceutical industry expertise within the safety constraints of a nuclear facility.

· All Radiopharmaceutical Items and Non-Radio Pharmaceutical Items are to be furnished by contractor in strict accordance applicable local, state and federal laws governing the receipt, handling, preparation and delivery of these isotopes for human use.

· Contractor shall provide the protocol followed (such as Food and Drug Administration (FDA) and or professional standards or guidelines) in determining expiration time or date on Radiopharmaceutical doses.

FINANCIAL RESPONSIBILITY: The required Radiopharmaceuticals shall be furnished from an established business that is financially responsible and able to show evidence of reliability, ability, experience, equipment, and personnel directly employed by the business and supervised by them to render prompt and satisfactory service.

AUTHORIZED STAFF TO PLACE ORDERS: The Radiopharmaceutical orders are to be placed by authorized Nuclear Medicine Professional staff. Upon award, the contractor will be furnished with the names of the Ralph H. Johnson VAMC personnel that are authorized to place orders against the contract. The following personnel are authorized to telephone and/or fax Radiopharmaceutical orders:

· Supervisory Nuclear Medicine Technologist

· Nuclear Medicine Technologists

· Other VA Medical Center Staff as designated DELIVERY: All Radiopharmaceutical Items and Non-Radio Pharmaceutical Items shall be ordered as needed by the Nuclear Medicine staff, for next day delivery. Requests will be placed daily during normal working hours of 7:00 am – 5:00 pm Monday through Friday excluding Federal Holidays.

· All Radiopharmaceuticals shall be delivered in properly shielded containers with disposable impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations. Copies of the Quality Control Information on the shipping certificate are to be sent DAILY to the Nuclear Medicine Section, Ralph H. Johnson VA Medical Center Charleston, South Carolina.

· All deliveries shall be delivered to the Nuclear Medicine technologist on duty at the Ralph H. Johnson VAMC, Nuclear Medicine (secured receiving area), 109 Bee street, Room B206C; Charleston, SC 29401-5799.

· If deliveries are to be received before 0700 Monday through Friday, Contractor must be escorted to the hot lab by VA Police.

· Delivery personnel will be required to sign in and out of visitors logbook located in Nuclear Medicine hot lab before leaving.

· The first daily delivery shall be made to Nuclear Medicine (secured receiving area) by 7:00 a.m. unless prior authorization arrangements have been made. Delivery shall be made directly to Nuclear Medicine Technologist, Nuclear Medicine (secured receiving area), Room B206C.

· Requests for emergency delivery during regular work hours (Monday through Friday 7:00 am-5:00 pm) shall be delivered within three (3) hours of placing the order.

· If the ordered Radiopharmaceutical is not available and cannot be delivered to the Ralph H. Johnson VAMC when needed; Contractor shall notify the VA Nuclear Medicine Department within one (1) hour of emergency request and four (4) hours of non- emergency request.

· Contractor shall obtain the needed doses from another source, including another Radiopharmacy, to be delivered as near the requested time in order to provide timely care to the Veteran patients.

· Contractor may only substitute another Radiopharmaceutical for the requested one with VA Nuclear Medicine and contracting office’s approval. When this is done, the VA will pay for the lower priced Radiopharmaceutical.

· All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges.

· No delivery charge shall be made for additional deliveries during normal working hours of Monday – Friday between the hours of 7:00 am-5:00 pm.

· Delivery personnel will be bonded by the contractor. Contractor shall provide supporting documentation of DOT certification for transport of Radiopharmaceuticals.

· Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

· Vendor will provide accurate emergency phone contact information for orders that are placed after normal working hours.

LICENSURE: Contractor shall provide verification of a valid radioactive material license issued by the SC State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. Proof of such licensure will be considered as verification that the Contractor has approved distribution procedures in place to ensure security of radioisotopes during receipt, preparation and delivery, as well as required training for delivery personnel and any others that may come in contact with Radiopharmaceuticals. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, and all other Federal and State agency rules and regulations.

· Contractor shall provide the protocol followed (such as FDA and or professional standards or guidelines) in determining expiration time or date on radiopharmaceutical doses.

· Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment.

· Contractor shall provide steps followed to ensure purity and sterility during preparation of Radiopharmaceuticals.

· Contractor shall declare the steps taken daily to ensure such efficacy.

· Contractor shall guarantee of the quality and efficacy of labeled compounds (Radiopharmaceuticals).

· Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products for the medical center.

· Contractor shall be Occupational Safety and Health Administration (OSHA) compliant. OSHA needle stick legislation requires that healthcare facilities must:

· Annually update their Exposure Control Plan (ECP)

· Use appropriate sharps devices or needleless systems

· Solicit frontline employee input to assist in the identification, evaluation and selection of new technology

· Establish sharps injury log to better track needle sticks

· To further ensure safety, Contractor shall:

· meet applicable regulatory requirements for USP <795>, USP <797>, USP <823> and cGMP Part 212

· ensure the integrity of each prescription by complying with stringent internal quality processes and standard operating procedures

· offer quality and safety-related continuing education courses on USP<797>, cGMP and radiation safety principles

· utilize safety products, to protect against needle sticks and contamination from blood borne pathogens

· use adequate syringe shields, to reduce radiation exposure.

· The Contractor must provide evidence that they have the ability to provide TC-99m from facilities that produce non-HEU (High Enriched Uranium) radioisotopes.

· NOTE-ALL Technectium-99m (Tc-99m) SHALL BE PROCURED FROM NON-HEU companies.

QUALITY CONTROL MANUAL: Contractor shall provide a copy of their pharmacy’s current Quality Control Manual. Contractor shall discuss any discrepancies’ in results. Copies of the Quality Control Information on the shipping certificate are to be sent DAILY to the Nuclear Medicine Section, Ralph H. Johnson VA Medical Center Charleston, South Carolina.

RECORD KEEPING / DOCUMENTATION: Accurate records must be kept for quality control, all inventories of shipments, all radiation safety requirements, all radiopharmaceutical characteristics and patient identification. Contractor shall meet all Nuclear Regulatory Commission, department of Transportation, National Health Physics Program, Food and Drug Administration, Occupational Safety and Health Administration, and all other agency rules and regulations (Federal and State). This information must be provided with every shipment.

QUALITY MANAGEMENT PROGRAM (QMP): Contractor shall provide its Quality Management Program (QMP). This program shall include, but not limited to:

· The Contractors procedure for the preparation of Radiopharmaceuticals

· Where preparation of Radiopharmaceuticals is carried out.

· Quality Control guidelines the Contractor follows for the dispensing, packaging and delivery of Radiopharmaceuticals for human use

· Verification of the steps followed to test labeling efficiency of Radiopharmaceutical kits and the frequency of this testing.

· The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to Ralph H. Johnson VAMC.

· The testing and the detailed report shall be furnished to Ralph H. Johnson VAMC at no additional cost.

· All quality control testing/procedures shall be performed as required by Federal and State regulatory agencies.

RADIOACTIVE LABEL & LABEL DOSE: Contractor shall label all unit doses of delivered Radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc. and provide a bar labeled insert to allow scanning data in the nuclear medicine information management system (NMIS). If the contractor's system varies from the current (BioDose) NMIS information system, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government.

· All Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date.

· All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated.

· Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

· All packaging of radioactive materials must be clearly labeled "radioactive" with the proper class and exposure levels, preparation time, expiration time and date and VA order number on the outside of the shipping container in order to comply with specific requirements.

· All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling and storage.

· Contractor must supply with each shipment /order/delivery a system for spent (used) syringes, which meets OSHA's Bio-Hazard Policy/ Regulations and is needless.

· Contractor shall provide steps followed to ensure purity and sterility during preparation of Radiopharmaceuticals.

· Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment.

· Contractor shall guarantee of the quality and efficacy of labeled compounds (Radiopharmaceuticals).

· Contractor shall declare steps taken daily to ensure such efficacy.

CREDIT: Contractor shall offer credit for unit doses that are not to be used or cancelled. The Ralph H. Johnson VAMC shall require credit statements (itemized returned doses) and monthly invoices. An electronic daily dose tracking system should be available for the Medical Center’s use in certifying and tracking per patient doses delivered. There will be no additional fees added to the invoices outside of the schedule/ price list that is provided by the vendor. This includes delivery fees, daily fees, service fees, dose prep fees and dose disposal fees.

· Contractor shall accept returns for credit under the following conditions:

a. Product(s) ordered or shipped in error

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer)

f. Unused doses of patients who fail to keep their appointments.

· Incorrectly delivered dose for any reason shall be credited for the full amount. Incorrectly delivered doses shall not exceed one per month.

· Recalled dose(s) for any reason shall be credited for the full amount. It is the offeror’s responsibility to provide the Ralph H. Johnson VAMC with recall notices on any product that has been delivered to the Nuclear Medicine Department may be defective. Notification shall be made to the Contracting Officer Representative (COR) via the most expedient method.

· Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one (1) per quarter; four (4) per year, from date of award.

· Emergency call back fees shall not be charged for regular work hours (Monday – Friday 7:00 am-5:00 pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc.

· The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the contractor’s expense. Replacements shall be received within forty-eight (48) hours of notification from the Ralph H. Johnson VAMC.

· Cold kits shall be returned to vendor for credit or replacement if expiration date is exceeded.

PERFORMANCE/QUALITY:

· Contractor shall have available an adequate supply of the contract products to meet the requirements of the facilities listed above at its distribution points.

· Incorrectly delivered doses shall not exceed one (1) per month.

· Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. four (4) per year.

· It is the offeror’s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method.

· All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated.

· Contractor shall provide complete documentation of quality control results upon request. Product information including supplier’s source of Radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier’s license and procedures shall be provided at no additional charge.

· Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service.

· All products are purchased subject to acceptance by the VA, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine’s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials.

· Product information including supplier's source of Radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided upon request at no additional charge.

INVOICING: Invoices shall be paid monthly in arrears. Invoices shall show period covered, billing date, name of preparation, quantity and amount. Contractor shall submit certified invoices monthly within 15 days after the end of billing month to the Contracting Officer’s Representative (COR) via e-mail to be reviewed for accuracy prior to submission to the Department of Veteran Affairs Financial Services Center for processing. Should the COR find discrepancies; contractor shall correct any discrepancies identified within two (2) business days and provide the Contracting Officer’s Representative (COR) with the revised invoice.

QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall provide verification of a valid radioactive material license issued by the SC State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director.

PERSONNEL POLICY: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel: worker's compensation professional liability insurance health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

MODIFICATION: In accordance with FAR 52.212-4(c), changes may only be made by a written modification which is formally executed by the contractor and the Contracting Officer.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. RHJ VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and RHJ VAMC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with RHJ VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public RHJ VAMC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The RHJ VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which RHJ VAMC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11.Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take RHJVAMC-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

~END SOW~

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PROVIDE RADIOPHARMACEUTICAL AND NON PHARMACEUTICAL NUCLEAR MEDICAN NEW BASE CONTRACT FOR PALMETTO ISOTOPES, PERIOD OF SERVICE 101921 TO 101822.

Contract Period: Base POP Begin: 10-19-2021 POP End: 10-18-2022

PROVIDE RADIOPHARMACEUTICAL AND NON PHARMACEUTICAL ISOTOPES FOR DELIVERY IN ACCORDANCE WITH THE STATEMENT OF WORK Contract Period: Option 1 POP Begin: 10-19-2022 POP End: 10-18-2023

PROVIDE RADIOPHARMACEUTICAL AND NON PHARMACEUTICAL ISOTOPES FOR DELIVERY IN ACCORDANCE WITH THE STATEMENT OF WORK Contract Period: Option 2 POP Begin: 10-19-2023 POP End: 10-18-2024

PROVIDE RADIOPHARMACEUTICAL AND NON PHARMACEUTICAL ISOTOPES FOR DELIVERY IN ACCORDANCE WITH THE STATEMENT OF WORK Contract Period: Option 3 POP Begin: 10-19-2024 POP End: 10-18-2025

PROVIDE RADIOPHARMACEUTICAL AND NON PHARMACEUTICAL ISOTOPES FOR DELIVERY IN ACCORDANCE WITH THE STATEMENT OF WORK Contract Period: Option 4 POP Begin: 10-19-2025 POP End: 10-18-2026

B.3 DELIVERY SCHEDULE

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

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

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

(End of Clause)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and…