Combined_Syn-Sol_NIH-P16-0018F.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

Specified prior to award

PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

NIH-P16-0018F

6. SOLICITATION ISSUE

DATE

03/16/2016

a. NAME

7. FOR SOLICITATION

INFORMATION CALL:

Lisa Schaupp - lisa.schaupp@nih.gov

b. TELEPHONE NUMBER (No collect calls)

301-402-0735

8. OFFER DUE DATE/

LOCAL TIME

05/31/2016 10:00 a.m. E.T.

10. ACQUISITION IS [X] UNRESTRICTED OR [ SET ASIDE

SMALL BUSINESS

|—| HUBZONE SMALL

CODE 9. ISSUED BY

National Institutes of Health Clinical Center Two Democracy Plaza, Suite 6707 Democracy MSC 5480 Bethesda, MD 20892-5480

% FOR:

WOMEN-OWNED SMALL BUSINESS

| | (WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

325412

SIZE STANDARD:

Employees

11. DELIVERY FOR FOB DESTINA

TION UNLESS BLOCK IS

MARKED

• SEE SCHEDULE

THIS CONTRACT IS A

RATED ORDER UNDER

700)

RATING

14. METHOD OF SOLICITATION

15. DELIVER TO

Department of Radiology and Imaging Sciences Nuclear Imaging Section and PET Department 10 Center Drive, Building 10, Bethesda, MD

16. ADMINISTERED BY

See Block 9

CODE

17a. CONTRACTOR/ CODE

OFFEROR

FACILITY

CODE

18a. PAYMENT WILL BE MADE BY CODE

Office of Financial Management Commercial Accounts

East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK UNLESS BLOCK

BELOW IS CHECKED | | SEE ADDENDUM

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

See Attachment 5 - Pricing Table

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

25. ACCOUNTING AND APPROPRIATION DATA TOTAL AWARD AMOUNT (For Govt. Use Only)

[X| 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

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

ARE ARE NOT ATTACHED

| | ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 2

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

| | 29. AWARD OF CONTRACT: REF. OFFER

DATED . . YOUR OFFER ON SOLICITATION

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. 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)

Julius Y. Tidwell

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM (REV.

Prescribed by GSA- FAR (48 CFR) 53.212

Combined Synopsis/Solicitation No. NIH-P16-0018F

COMBINED

SYNOPSIS/SOLICITATION

TABLE OF CONTENTS

PART - THE S C H E D U L E 3

SECTION B - SUPPLIES OR S E R V I C E S AND P R I C E S / C O S T S 3

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 4

SECTION D - PACKAGING, MARKING AND SHIPPING 4

SECTION E - INSPECTION AND ACCEPTANCE 5

SECTION F - DELIVERIES OR PERFORMANCE 5

SECTION G - CONTRACT ADMINISTRATION DATA 6

SECTION H - SPECIAL CONTRACT REQUIREMENTS 8

PART II - CONTRACT C L A U S E S 10

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS 16

SECTION J - L IST OF ATTACHMENTS 16

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS 16

BUSINESS PROPOSAL ATTACHMENTS 16

INFORMATIONAL ATTACHMENTS 16

PART IV - REPRESENTATIONS AND INSTRUCTIONS 17

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF O F F E R O R S

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO O F F E R O R S 18

SECTION M - EVALUATION OF PROPOSALS 22

NIH-P16-0018F

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) MAY BE DISCUSSED IN THE NEGOTIATION

PROCESS AND MAY BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT

SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO

UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of the solicitation is to create a single-award contract whereby, on order, shall procure unit doses of Fludeoxyglucose Each dose shall be contained in a shielded single-dose administration container (referred to as a "pig"), and at least two pigs further contained in a shielded shipping container. The complete system must meet DOT regulations, USNRC ALARA, and Government weight guidelines.

The shielding must protect NIH employees and members of the public from exposure, minimizing exposure to the extent as low as is reasonably achievable ("ALARA") as provided in the Statement of Work. The must come from a production facility which is approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce for human use. Additionally, the offeror must possess a license which is in good standing for the production and/or distribution of by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval). More details are provided in the Statement of Work. The deliveries shall allow the NIH Nuclear Medicine Department of Radiology and Imaging Sciences to perform clinical imaging studies as required by necessary patient care protocols at the NIH Clinical Center.

ARTICLE B.2. PRICES/COSTS

a. This solicitation contemplates the creation of a FAR single-award contract. The guaranteed minimum for the contract is $200. The awarded value ceiling for the contract shall be $2.8 million.

b. The offeror's proposed unit pricing will cover a five-year contract period (one base year and four option years), which will likely start in July 2016 and end in June 2021.

c. The Government issue orders for dose deliveries based upon the unit prices which the awardee proposes when it completes and returns the pricing table at Attachment 5. See SECTION J - List of Attachments. To be clear, the unit prices which an offeror proposes shall be the unit prices which apply to orders during contract performance. However, the estimated quantities provided in the pricing table are not quantities which the Government is committing to order during contract performance. Rather, the quantities are provided so that an offeror will have a basis upon which to construct a total evaluated price which will facilitate an comparison of offeror prices during source selection. Indeed, the exact quantity of doses which will be ordered is unknown, which is why the solicitation contemplates an contract.

ARTICLE B.3. ADVANCE UNDERSTANDINGS

All costs of production, containment, and delivery of doses should be included in the offeror's unit prices.

Any other travel, such as foreign travel, is not expected to be required under the contract, and in any event, may not be charged to the contemplated contract without being directed and approved by the Contracting Officer. If the rare event should occur where the Contracting Officer orders extraordinary travel, all travel costs shall be in accordance with FAR 31.205-46, relevant portions of the Federal Travel Regulation, and applicable law.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, vehicles, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work provided at Attachment 3. See SECTION J - List of Attachments.

ARTICLE C.2. REPORTING REQUIREMENTS

The preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

For proposal preparation purposes only, it is anticipated that Technical Progress Reports will be required as follows.

[ ] Monthly [ ] Quarterly [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of each Task Order

[X ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

All reports required shall be submitted in electronic format.

The purpose of the anticipated contract does not involve the procurement of electronic and information technology as defined at FAR and contemplated by FAR Subpart 39.2. Consequently, Section 508 of the Rehabilitation Act of generally speaking, does not apply to this procurement. Nonetheless, in order to promote workforce inclusivity, NIH requires that all of a contractor's electronically submitted annual and final reports be compliant with Section 508 of the Rehabilitation Act of Specifically, word processor documents or PDFs can be made accessible simply through the careful selection of the formatting and options provided in the word processor program. In turn, the will be able to use an accessibility program such as Word Eyes to read the document. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: under "Making Files Accessible." Because making a document Section 508 accessible is relatively simple and should not require any special software purchases on the part of the contractor, the contractor should expect that the accessible reports requirement shall be enforced throughout contract performance.

SECTION D - PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. PACKAGING

The packaging and transport of all deliveries shall meet relevant U.S. Department of Transportation transportation requirements for radioactive materials. Please refer to the Statement of Work for more information.

ARTICLE D.2. MARKING

The markings of all deliveries shall meet relevant U.S. Department of Transportation transportation requirements for

- 4 -radioactive materials.

ARTICLE D.3. SHIPPING

Containers shall be shielded and shipped according to the delivery specifications in the attached Statement of Work.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer's duly authorized representative(s) will perform inspection and acceptance of materials and services to be provided. As provided in the Statement of Work, an dose will not be considered delivered unless the contractor/contractor's agent has placed the radiopharmaceutical in the custody of an NIH RSO certified Nuclear Medicine person.

b. For the purpose of this SECTION, (To be announced at time of award) is the authorized representative(s) of the Contracting Officer.

c. Inspection and acceptance will be performed at:

The National Institutes of Health Bethesda, MD 20892 (The specific address at NIH shall be provided to the awarded contractor.)

The Government reserves the right to an inspection period of three calendar days, unless a longer time period is stated elsewhere in the Contract or in the delivery order. The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-1, Contractor Inspection Requirements (April 1984).

FAR Clause 52.246-2, Inspection of Supplies - Fixed Price (August

FAR Clause 52.246-16, Responsibility for Supplies (April

Transportation is f.o.b. destination.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The performance period shall be for one base year and four option years, which will likely start in July and end in June 2021

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of the contemplated contract, the period of performance will be increased as listed below:

Option Period Estimated Period of Performance

Option Period One (1) July 1, 2017 through June 30, 2018

Option Period Two (2) July 1, 2018 through June 30, 2019

Option Period Three (3) July 1, through June 30, 2020

Option Period Four (4) July 1, 2020 through June 30, 2021

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer's duly authorized representative(s), of the following items in accordance with the stated delivery schedule:

- 5 -

a. The items specified below will be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL and in accordance with and by the date(s) specified in the Statement of Work and the relevant Purchase Order [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this solicitation]:

Item Description Quantity Delivery Schedule

FDG unit doses in Shielded Delivery and Administration System

According to issued Task Order and as requested by authorized technician

To arrive at least 30 minutes before the calibration time, as called in by Nuclear or PET Imaging Staff

(2) STAT or (Latin for Immediate) order of FDG unit doses in Shielded Delivery and Administration System

According to issued Task Order and as requested by called in order

Same day within three (3) hours of called in order, for delivery 30 minutes prior to calibration time of requested dose

b. The above items shall be addressed and delivered to the National Institutes of Health campus in Bethesda, MD. A precise delivery addresses shall be provided to the awardee.

c. Unless otherwise specified, deliveries shall be made to the specified delivery point Mondays through Fridays (excluding Federal Holidays) between the hours of 5:30 a.m. and 5:30 p.m. ET only. Delivery hours are different from the calibration times required in the Statement of Work and take into consideration arrival of the dose(s) 30 minutes prior to calibration time. However, as provided in the Statement of Work, the occasional STAT delivery may be required on a weekend.

ARTICLE F.3. TIME OF DELIVERY

The Government requires delivery of FDG unit doses within 1 business day after an order is placed, and as required to be timely for appointed calibration.

ARTICLE F.4. C L A U S E S INCORPORATED BY R E F E R E N C E , FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

FAR Clause 52.242-15, Stop Work Order (August 1989) Alternate (April 1984) is applicable to this contract.

FAR Clause Government Delay of Work (April

FAR Clause 52.247-35, F.o.b. Destination Within Consignees Premises (April

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

To be announced at time of award.

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

- 6 -assisting in the resolution of technical problems encountered during performance.

[The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

The Contracting Officer is the only person with authority to act as agent of the Government for altering the contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its designated COR.

ARTICLE G.2. METHOD OF ORDERING

a. Orders issued under this contract may be placed as follows:

[X] in writing [X] via telephone for ordering specific doses under each Task Order [X] via facsimile (fax) [X] via electronic mail (e-mail) to issue Task Orders from which telephone orders will be made.

[X] Oral (Oral Orders will be confirmed in writing within 1 days of issuance).

[X] Other Specify: Issuance of Task Order authorizes all ordering methods not to exceed Task Order funded amount.

b. The Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract. E-mail: Lisa.Schaupp@nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MS Word, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail. Further, the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

Contracting Officer's Representative (TBD)

The Contractor shall submit an electronic copy of the payment request to the Contracting Officer's Representative.

The payment request shall be transmitted as an attachment to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

ARTICLE G.3. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

a. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

b. The original invoice shall be submitted to the following designated billing office.

National Institutes of Health Office of Financial Management Commercial Accounts

East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

- 7 -

d. One copy of the invoice shall be submitted to the following approving official: Lisa Schaupp, Contract Specialist

Central Point of Distribution: The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox.

e. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

ARTICLE G.4. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the pre-award negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the Publication, entitled, Contracting Guide for Contract of Government Property," which can be found at: http://oamp.od.nih.gov/sites/default/ files/appendix q hhs contracting quide.pdf.

Of note, NIH does not anticipate that any Government-furnished property will be required for the contractor to perform.

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually within 30 days after to the expiration date of each Period of Performance.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN S U B J E C T S

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.3. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION

OF CONTROLLED SUBSTANCES

- 8 -

The Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule of the schedules of controlled substances established under section 202 of the Controlled Substances Act, except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

ARTICLE H.4. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.

Pursuant to FAR Clause Option to Extend the Term of the Contract set forth in SECTION of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and funding obligated under the contract will be increased in accordance with Article B and the placement of orders.

ARTICLE H.5. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is (1-800-447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is and the mailing address is as follows.

US Department of Health and Human Services Office of Inspector General

ATTN: HOTLINE OPERATIONS P.O.

Box 23489 Washington, D.C. 20026

PART II - CONTRACT CLAUSES

SECTION - CONTRACT C L A U S E S

ARTICLE GENERAL CONTRACT C L A U S E S

THE FOLLOWING ARTICLE GENERAL CLAUSES WILL LIKELY BE APPLICABLE TO THE CONTRACT

RESULTING FROM THIS RFP. HOWEVER, THE STRUCTURE OF THE SUCCESSFUL

OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSE LISTING TO BE CONTAINED IN THE

CONTRACT(S) AWARDED FROM THIS RFP.

52.202- 1 Nov 2013 Definitions (Over the Simplified Acquisition Threshold)

52.203- 3 Apr Gratuities (Over the Simplified Acquisition Threshold)

52.203-5 May 2014 Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)

52.203-6 Sep 2006 Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)

52.203-7 May Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)

52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)

Apr Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)

52.203-99 Feb 2015 Prohibition on Contracting with Entities That Certain Internal Confidentiality Agreements (DEVIATION)

52.204-4 May Printed or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified Acquisition Threshold)

Oct Reporting Executive Compensation and First-Tier Subcontract Awards ($30,000 or more)

- 1 0 -

52.204-13 Jul System for Award Management Maintenance

52.209-6 Oct Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $35,000)

52.211-5 2000 Material Requirements

Oct 2010 Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, A N D contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]

52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format

Aug Price Reduction for Defective Certified Cost or Pricing Data (Over $750,000)

52.215-12 Oct 2010 Subcontractor Cost or Pricing Data (Over $750,000)

52.215-14 Oct 2010 Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over $750,000)

52.215-18 Jul 2005 Reversion or Adjustment of Plans for Benefits other than Pensions

52.215-19 Oct 1997 Notification of Ownership Changes

52.215-21 Oct 2010 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications

Oct 2014 Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)

52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $700,000, $1.5 million for Construction)

52.222-19 Feb 2016 Child with Authorities and Remedies

52.222-20 May 2014 Contracts for Materials, Supphes, Articles, and Equipment Exceeding

-11 -

52.222-21 Apr of Segregated Facilities 52.222-26 Apr 2015 Equal Opportunity

52.222-35 Oct 2015 Equal Opportunity for Veterans or more)

52.222-36 Jul 2014 Equal Opportunity for Workers with Disabilities

52.222-37 Feb Employment Reports on Veterans or more)

52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)

52.222-50 2015 Combating Trafficking in Persons

52.222- 54 Oct Employment Eligibility Verification (Over the Simplified Acquisition Threshold)

52.223- 6 May 2001 Drug-Free Workplace

Aug Encouraging Contractor Pohcies to Ban Text Messaging While Driving

52.225-1 May 2014 Buy American - Supplies

52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases

52.227-1 Dec 2007 Authorization and Consent

52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement

52.229-3 Feb 2013 Federal, State and Local Taxes (Over the Simplified Acquisition Threshold)

52.232-1 Apr 1984 Payments

52.232-8 Feb 2002 Discounts for Prompt Payment

- 1 2 -

52.232-9 Apr Limitation on Withholding of Payments

52.232-11 1984 Extras

May 2014 Interest (Over the Simplified Acquisition Threshold)

52.232-23 May 2014 Assignment of Claims

52.232-25 2013 Prompt Payment

52.232-33 Jul 2013 Payment by Electronic Funds for Award Management

52.232- 39 2013 Unenforceabihty of Unauthorized Obhgations

52.233- 1 2014 Disputes

52.233-3 1996 Protest After Award

52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim

52.242- 13 Jul Bankruptcy (Over the Acquisition Threshold)

52.243- 1 1987 Changes - Fixed-Price

52.244- 6 Feb Subcontracts for Commercial Items

52.249-2 Apr 2012 Termination for the Convenience of the Government (Fixed-Price)

52.249-8 Apr 1984 Default (Fixed-Price Supply and the Simphfied Acquisition Threshold)

52.253-1 Jan 1991 Computer Generated Forms

1 3 -

352.203-70 Dec 2015 Anti-Lobbying

352.222-70 Dec Contractor Cooperation in Equal Employment Opportunity Investigations

352.227-70 Dec 2015 Publications and Publicity

352.237-75 Dec 2015 Key Personnel

ARTICLE ADDITIONAL CONTRACT C L A U S E S

This contract incorporates the following clauses by reference, (unless otherwise noted), 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.

1. FAR Clause Contractor Code of Business Ethics and Conduct (October

2. FAR Clause Commercial and Government Entity Code Maintenance (July 2015).

3. FAR Clause Prohibition on Contracting With Inverted Domestic Corporations (November 2015).

4. FAR Clause Option for Increased Quantity (March

Contracting Officer may exercise the option by written notice to the Contractor within 5 days of the expiration date of the Contract "

5. FAR Clause 52.223-3, Hazardous Material Identification and Material Safety Data (January with Alternate (July 1995).

6. FAR Clause 52.246-23, Limitation of Liability (February 1997).

7. HHSAR Clause 352.223-70, Safety and Health (December

ARTICLE I.3. ADDITIONAL FAR CONTRACT C L A U S E S INCLUDED IN FULL TEXT

This contract incorporates the following clause(s) in full text.

FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July 2013).

As prescribed in insert the following clause:

a. The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life the contract, by posting the required information in the System for Award Management (SAM) database at http://www.

b. As required by section of the Supplemental Appropriations Act, 2010(Pub. L. 111-212), all information posted in FAPIIS on or after April 15, except past performance reviews, will be publicly available. FAPIIS consists of

1. The non-public segment, into which Government officials and the Contractor post information, which can only be viewed

Government personnel and authorized users performing business on behalf of the Government; or

/'/'. The Contractor, when viewing data on itself; and

2. The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for-

i. Past performance reviews required by subpart

//'. Information that was entered prior to April or

Information that is withdrawn during the waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

c. The Contractor will receive notification when the Government posts new information to the Contractor's record.

1. the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

2. The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

3. As required by section 3010 of Pub. L. all information posted in FAPIIS on or after April except past performance reviews, will be publicly available.

d. Public requests for system information posted prior to April will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated E.O.

(End of clause)

FAR Clause 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 any time prior to the expiration of the contract; 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 60 months.

(End of Clause)

- 1 5 -

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

SOLICITATION ATTACHMENTS

Attachment No.

Attachment Attachment 2:

Attachment 3:

Attachment 4:

Attachment 5:

Attachment 6:

Title Location Packaging and Delivery of Proposal (Non R & D ) Proposal Intent Response Sheet Statement Work Section K - Representations, Certifications, and Other Statements of Offerors Pricing Table Past Performance Questionnaire

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Attachment 7: Summary of Related Activities

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Attachment 8: Proposal Summary and Data Record, Attachment 9: Offeror's Points of Contact

Attachment Disclosure of Lobbying Activities, OMB Form SF-LLL

Location activities.pdf

Location http://oamp.od.nih.gov/sites/default/files/

IH2043.pdf http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/point-of-contact.pdf http://www.gsa.gov/portal/forms/

INFORMATIONAL ATTACHMENTS

Attachment No. Title Location Attachment Invoice Instructions for NIH Fixed Price http://oamp.od.nih.gov/sites/default/files/

Contracts NIH(RC)-2 DGS/contracting-forms/rc2 508.pdf

Combined Synopsis/Solicitation F18-FDG Unit Doses in Shielded Delivery and Administration Containers

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF O F F E R O R S

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST:

Go to the System for Award Management (SAM) and complete the Representations and Certifications. The SAM website may be accessed at

2. Complete and include as part of your proposal SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS, which is included as an Attachment in the Section J- LIST OF

ATTACHMENTS.

If you are unable to access this SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS electronically, you may request a copy from the Contracting Officer identified in the solicitation.

3. The fol lowing clause is incorporated.

FAR Clause 52.204-19, Incorporation by Reference of Representations and Certifications (December 2014).

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)

SECTION L - INSTRUCTIONS. CONDITIONS, AND NOTICES TO OFFERORS

NAICS CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in preparing its Representations and Certifications (See Section K of this RFP).

The North American Industry Classification System (NAICS) code for this acquisition is 325412.

2. The small business size standard is 1,250 employees.

THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in every solicitation, (except for foreign acquisitions) the inclusion of the North American Industry Classification System (NAICS) Code and corresponding size standard which best describes the nature of the solicitation requirement.

T Y P E OF CONTRACT AND NUMBER OF AWARDS

It is anticipated that one award will be made from this solicitation and that the award(s) will likely be made in July Nonetheless, the Government still reserves the right to make more than one award.

2. It is anticipated that the award(s) from this solicitation will be a Single Award Indefinite Delivery/ Indefinite Quantity Type contract with Fixed-Price Orders and a Term of One (1) Base Period and Four (4) month Option Periods.

Accordingly, the following clauses are incorporated by reference.

FAR Clause Indefinite Quantity (OCT 1995).

FAR Clause Single or Multiple Awards (OCT

- 1 7 -

COMMITMENT OF PUBLIC FUNDS

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.

COMMUNICATIONS PRIOR TO CONTRACT AWARD

Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this SOLICITATION. Communications with other officials may compromise the competitiveness of this acquisition and possibly result in the exclusion of the communicating offeror.

R E L E A S E OF INFORMATION

Contract selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, or to offerors following award. Written notice may be in the form of a Fedbizopps posting.

PROPOSAL PREPARATION C O S T S

This RFP does not commit the Government to pay for the preparation and submission of any proposal.

The following clause is incorporated. FAR Clause 52.233-2, Service of Protest (SEP 2006).

(a) Protests, as defined in section of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Julius Y. Tidwell Contracting Officer Office of Purchasing and Contracts 6707 Democracy Room Bethesda MD 20892

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

INSTRUCTIONS TO O F F E R O R S

The following instructions discuss the format and contents of proposals. Please pay close attention to the instructions.

The following clause is incorporated. FAR Clause 52.215-1, Instructions to Acquisition (JAN 2004).

(a) Definitions. As used in this provision—

"Discussions" are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal.

"In writing," "writing," or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information.

"Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award.

"Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations.

- 1 8 -

"Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day.

(b) Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the

(c) Submission, modification, revision, and withdrawal of proposals.

(1) Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision.

(2) The first page of the proposal must

(i) The solicitation number;

(ii) The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available);

(iii) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item;

(iv) Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and

(v) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office.

(3) Submission, modification, revision, and withdrawal of proposals.

(i) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due.

(ii) (A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition;

(1) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of or

(2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(3) It is the only proposal received. .

(B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(iii) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at

Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award.

(4) Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items.

(5) Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR Evaluation of Foreign Currency Offers, is included in the solicitation. '

(6) Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award.

(7) Offerors may submit revised proposals only if requested or allowed by the Contracting Officer.

(8) Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer.

(d) Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror).

(e) Restriction on disclosure and use of data. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes,

(1) Mark the title page with the following legend:

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or whole or in any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result in connection submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]; and

(2) Mark each sheet of data it wishes to restrict with the following legend:

or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.

(f) Contract award.

(1) The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation.

(2) The Government may reject any or all proposals if such action is in the Government's interest.

(3) The Government may waive informalities and minor irregularities in proposals received.

(4) The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR Therefore, the offeror's initial proposal should contain the…