BEST_Sol_Develop_New_Innovative_Adverse_Event_Reporting_Capabilities.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NUMBER

1181185B

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

1181185B

6. SOLICITATION ISSUE DATE

8/1/2017

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Nick Sartain

b. TELEPHONE NUMBER (No collect calls)

(870) 543-7370

8. OFFER DUE DATE / LOCAL

TIME

8/22/2017 13:00 hours Central Time

9. ISSUED BY CODE HFT-323 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: FOR:

FDA/OO/OFBA/OAGS/DAP

SMALL BUSINESS WOMEN-OWNED SMALL BUSINESS

Field Operations Branch Nick Sartain

HUBZONE SMALL

BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM NAICS:

518210 3900 NCTR Road, Building 50, Room 422 Jefferson AR 72079-9502

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

EDWOSB

8 (A) SIZE STANDARD:

$32.5

11. DELIVERY FOR FOB DESTINAT-

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

FDA

White Oak Campus, Silver Spring MD 20993

SAME AS BLOCK 9

17a. CONTRACTOR/

OFFERER

TELEPHONE NO.

CODE FACILITY

CODE

18a. PAYMENT WILL BE MADE BY Food and Drug Administration Vendor Payments 10903 New Hampshire Ave, WO32-Second Floor Silver Spring, MD 20993 FDAVendorPaymentsTeam@fda.hhs.gov

CODE

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.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

Biologics Effectiveness and Safety (BEST) Initiative, Develop New, Innovative Methods for Automation of Blood Product Adverse Event Reporting, as outlined herein and in the provided Attachments.

(Use Reverse and/or Attach Additional Sheets as

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 __1__

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 HEREIN.

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. 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 STANDARD FORM 1449 (REV. 02/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212 mailto:FDAVendorPaymentsTeam@fda.hhs.gov

FDA-SOL-1181185B Page 2 of 36

TABLE OF CONTENTS

SECTION B - CONTINUATION OF STANDARD FORM (SF) 1449

B.1 3-WAY INVOICE SUBMISSION INSTRUCTIONS – Addendum to SF1449 Block 18b B.2 SERVICES AND PRICES/COSTS – Addendum to SF 1449, blocks 19/20

B.2.1 Description of Services B.2.2 Pricing Schedule B.2.3 Pricing Terms B.2.4 Contract Type B.2.5 Travel B.2.6 Packing, Marking and Shipping B.2.7 Inspection and Acceptance B.2.8 Deliveries or Performance B.2.9 Contract Period of Performance

B. CONTRACT ADMINISTRATION DATA

B.3.1 Government Personnel B.3.1.1 Contracting Officer (CO) B.3.1.2 Contract Specialist (CS) B3.1.4 Contractor’s Point of Contact B.3.2 Contractor Personnel B.3.3 Contractor Performance Evaluations B.4 Tobacco Free Facilities B.5 Observance of Legal Holidays B.6 Government Rights to Data B.7 Reporting Matters Involving Fraud, Waste and Abuse B.8 Organizational Conflicts of Interest B.9 Data Disclosure Procedures

SECTION C – CONTRACT CLAUSES

C.1 FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (MAY 2015)

ALTERNATE I (JAN 2017)

C.2 ADDENDUM TO FAR CLAUSE 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL

ITEMS (JAN 2017 Alt I JAN 2017)

C.2.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2.2 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS (DEVIATION 2015-02) (FEB 2015)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS – COMMERCIAL ITEMS (JAN 2017)

SECTION D – LIST OF CONTRACT DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION E – SOLICITATION PROVISIONS

E.1 FAR 52.212-1, INSTRUCTIONS TO OFFERORS -- COMMERCIAL ITEMS (JAN 2017)

E.2.1.1 ADDENDUM TO FAR CLAUSE 52.212-1 INSTRUCTIONS TO OFFERORS -- COMMERCIAL

ITEMS (JAN 2017)

FAR 52.212-1 is tailored to include the following instructions for submission of Offerors

a. General Instructions for the Preparation and Submission of Offeror Proposals

E.2.1.2 VOLUME I – TECHNICAL PROPOSAL INSTRUCTIONS

E.3.1 Proposal Disqualification

E.3.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.3.4 52.203-98 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS—REPRESENTATION (DEVIATION 2015-02)

E.3.5 52.212-2 EVALUATION–COMMERCIAL ITEMS (OCT 2014)

FDA-SOL-1181185B Page 3 of 36

E.3.6 52.212-3 OFFERORS REPRESENTATIONS AND CERTIFICATIONS–COMMERCIAL ITEMS (JAN

2017)

FDA-SOL-1181185B Page 4 of 36

SECTION B - CONTINUATION OF STANDARD FORM (SF) 1449

B.1 3-WAY INVOICE SUBMISSION INSTRUCTIONS – Addendum to SF1449 Block 18b A. The contractor shall submit all invoices to:

U.S. Food and Drug Administration Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements) ;

(iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; (c) any other supporting information necessary to clarify questionable expenditures (d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

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

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

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

mailto:FDAVendorPaymentsTeam@fda.hhs.gov

FDA-SOL-1181185B Page 5 of 36

(ix) Taxpayer identification number (TIN);

(x) banking routing transit number of the financial institution receiving payment for electronic funds transfer

(EFT);

(xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

B.2 SERVICES AND PRICES/COSTS – Addendum to SF 1449, blocks 19/20 B.2.1 Description of Services U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Biologics Effectiveness and Safety (BEST) Initiative, New, Innovative Methods for Automation of Blood Product Adverse Event Reporting. The Contractor shall perform work in accordance with the terms, conditions and Statement of Work (SOW) contained herein. (See Part 1, Section C, Scope of Work and Part III, Section J, Attachment 1 – Statement of Work (SOW), and attachments thereto, as identified in Section D- List of Attachments, to this contract.

B.2.2 Pricing Schedule Contract Line Item No. (CLIN)

Description Total Price

Develop New, Innovative Methods such as machine learning, artificial intelligence, natural language processing and others for Automation of Blood Product Adverse Event Reporting.

B.2.3 Pricing Terms The Contractor shall comply with FAR 52.232-7, Payments Under Time and Material and Labor-Hour Contracts, with regard to the ceiling price. Upon presentation of a proper invoice, payment will be made monthly, in arrears, for services/supplies rendered to and accepted by the Government.

FDA-SOL-1181185B Page 6 of 36

B.2.4 Contract Type

Time and Materials Contract with an estimated ceiling of $2.5 Million.

B.2.5 Travel

a. There is no routine travel anticipated other than meetings at the FDA campus under this requirement. If at a future date the Government does require one or more Contractor employees to travel (training, conferences, etc.), the task order travel line item will be funded and the Contractor will be responsible for making all required travel arrangements for Contractor’s personnel. Upon completion of travel, in accordance with FAR 31.205-46, Travel Costs, Contractor will be reimbursed only for actual travel costs incurred. No additional profit, G&A or fee of any kind will be allowed on the direct travel reimbursement.

b. Travel claims/invoices shall be submitted separately from monthly service invoices. Listed below is a description of receipts required as attachments to the invoice to support travel claims:

1. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

2. Lodging receipt;

3. Parking/tolls receipts;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

B.2.6 Packing, Marking and Shipping B.2.6.1 Preparation of Delivery. All material to be delivered hereunder shall be afforded the degree of packing (preservation and packing) required to prevent deterioration and damages due to hazards of shipment, handling and storage. Best commercial practice will be accepted. All postage and fees related to distribution of deliverable including forms, reports, etc., shall be paid by the Contractor.

B.2.7 Inspection and Acceptance Pursuant to the appropriate inspection clause as provided below, the Contracting Officer’s Representative (COR), a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR specified herein.

B.2.8 Deliveries or Performance B.2.8.1 Reporting Requirements and Deliverables. Deliverables required by this contract are outlined in the SOW.

B.2.8.2 Contractor Notice Regarding Late Delivery. In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the CO giving pertinent details. The data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the contractor or any other rights or remedies provided to the Government by law or under this contract.

B.2.9 Contract Period of Performance The anticipated performance period is 13 months from date of award

B. CONTRACT ADMINISTRATION DATA

B.3.1 Government Personnel Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, administration of this contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government’s points of contact during performance of the contract:

B.3.1.1 Contracting Officer (CO). The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (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; or (5) otherwise change any terms and conditions of this contract.

The Contracting Officer for this contract is Nick Sartain.

B.3.1.2 Contract Specialist (CS). All communications pertaining to contractual and/or administrative matters under the contract shall be addressed to the CS at the following address:

FDA-SOL-1181185B Page 7 of 36

Attn: Nick Sartain

FDA/OO/OFBA/OAGS/DAP/FOB

3900 NCTR Road, Building 50, Room 422 Jefferson, AR 72079 Phone: (870) 543-7370 or electronically at nick.sartain@fda.hhs.gov

B.3.1.3 Contracting Officer’s Representative (COR). The following CORs will represent the Government for the purpose of this contract: (To be provided at contract award)

(a) Performance of the work under this contract shall be subject to the technical direction of the COR identified above, or a representative designated in writing. The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise services to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have the authority to issue any technical direction that:

(1) Constitutes a change of assignment of additional work outside the specification(s) / PWS;

(2) Constitutes a change as defined in the contract clause entitled "Changes”;

(3) In any manner causes an increase or decrease in the total contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract.

(5) Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor’s employees.

(c) Technical directions may be oral or in writing. The COR shall confirm oral direction in writing within five work days, with a copy to the CO.

(d) The Contractor shall proceed promptly with the performance resulting from the technical directions issued by the COR. If, in the opinion of the contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the CO no later than the beginning of the next Government work day.

(e) Failure of the contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor setting forth, in full, the responsibilities and limitations of the COR.

B3.1.4 Contractor’s Point of Contact To be completed at time of award.

Name:

Phone:

Email:

B.3.2 Contractor Personnel Pursuant to HHSAR Clause 352.237-75, Key Personnel, the contractor shall provide a complete list of all key personnel.

Key Personnel list will be included upon contract award.

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or mailto:suzanne.martella@fda.hhs.gov

FDA-SOL-1181185B Page 8 of 36 separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

B.3.3 Contractor Performance Evaluations In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract.

Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at https://www.ppirs.gov/.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm . There is no fee for registration or use of the CPARS.

B.4 Tobacco Free Facilities In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees and any subcontractor staff is made aware of, understand, and comply with this policy.

B.5 Observance of Legal Holidays The Government hereby provides “NOTICE” and the Contractor hereby acknowledges “RECEIPT” that government personnel observe the listed days as holidays:

Washington’s Birthday Memorial Day Independence Day Labor Day Veteran’s Day Thanksgiving Day Christmas Day New Year’s Day Columbus Day Martin Luther King’s Birthday Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President’s Proclamation

When any day falls on a Saturday, the preceding Friday is observed; when any day falls on a Sunday, the following Monday is observed. It is understood and agreed between the Government and the Contractor that observance of such days by government personnel shall not “on its face” be cause for an additional period of performance, or http://www.cpars.csd.disa.mil/cparsmain.htm https://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

FDA-SOL-1181185B Page 9 of 36 entitlement of compensation except as set forth within the contract. Contractor employees performing duties at a non-governmental facility are not automatically relieved from duty by virtue of the fact that government employees are dismissed early or given the day off.

B.6 Government Rights to Data The Government will acquire the right to use, duplicate, or disclose in any manner and for any purpose, and have or permit others to do so, all data required to be delivered under any contract resulting from this solicitation.

B.7 Reporting Matters Involving Fraud, Waste and Abuse Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA 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-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially.

The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

B.8 Organizational Conflicts of Interest

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict.

The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities.–1, and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in

FDA-SOL-1181185B Page 10 of 36

FAR Part 9.507

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) All contractor personnel involved in this requirement shall abide by the FDA Commitment to Protect Non-Public Information Agreement.

B.9 Data Disclosure Procedures Dissemination, Publication and Distribution of Information Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

Any questions about use or release of the data or information or handling of material under this contract shall be referred to the COR who must render a written determination to the Contracting Officer (CO). The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the CO will make a final decision concerning the release of information.

FDA-SOL-1181185B Page 11 of 36

SECTION C – CONTRACT CLAUSES

C.1 FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (MAY 2015)

ALTERNATE I (JAN 2017)

This clause is incorporated by reference (Refer to SF1449 Block 27a).

C.2 ADDENDUM TO FAR CLAUSE 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (JAN 2017 Alt I JAN 2017) (Refer to SF1449 Block 27a)

C.2.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

FAR Clauses: http://www.acquisition.gov/far/index.html HHSAR Clauses: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR

Clause Title and Date

52.203-6 Restrictions on Sub-contractor Sales to the Government. (SEP 2006) 52.203-7 Anti-Kickback Procedures. (MAY 2014) 52.203-13 Contractor Code of Business Ethics and Conduct (OCT 2015) 52.203-14 Display of Hotline Poster(s). (OCT 2015) 52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of

Whistleblower Rights. (APR 2014) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality

Agreements or Statements-Representation (JAN 2017) 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011) 52.204-9 Personal Identity Verification of Contractor Personnel. (JAN 2011) 52.204-13 System for Award Management Maintenance (JUL 2013) 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2015) 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015) 52.222-49 Service Contract Labor Standards—Place of Performance Unknown (May 2014) “none”. “August 1, 2017”.

52.227-11 Patent Rights—Ownership by the Contractor (May 2014) 52.227-14 Rights in Data—General (May 2014) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(DEC 2013)

52.242-5 Payments to Small Business Subcontractors (JAN 2017)

HHSAR NUMBER TITLE DATE

352.203-70 Anti-Lobbying Dec 2015 352.208-70 Printing and Duplication Dec 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations Dec 2015 352.223-70 Safety and Health Dec 2015 352.231-70 Salary Rate Limitation Dec 2015 352.233-71 Litigation and Claims Dec 2015 352.237-75 Key Personnel Dec 2015

C.2.2 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS (DEVIATION 2015-02) (FEB 2015)

(a) The Contractor shall not require employees or contractors seeking to report fraud, waste, or abuse to sign or http://www.acquisition.gov/far/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FDA-SOL-1181185B Page 12 of 36 comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.

(c) The prohibition in paragraph (a) of this clause does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(2) The Government may seek any available remedies in the event the contractor fails to comply with the provisions of this clause.

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS – COMMERCIAL ITEMS (JAN 2017)

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

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

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

3805 note)).

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

[Contracting Officer check as appropriate.] X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995)

(41 U.S.C. 4704 and 10 U.S.C. 2402).

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

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June

2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-

282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

X (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

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

X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C.

2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

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

__ (ii) Alternate I (Jan 2011) of 52.219-4.

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FDA-SOL-1181185B Page 13 of 36

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

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

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

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

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

X (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

X (17)(i) 52.219-9, Small Business Subcontracting Plan (JAN 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

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

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

X (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C.

657 f).

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

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned

Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns

Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

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

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

X (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

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

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

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

13496).

X (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

X (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction.

At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

__ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).

__ (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008)

(42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun

2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners

(Jun 2016) (E.O. 13693).

__ (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

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FDA-SOL-1181185B Page 14 of 36

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

X (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and

13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__ (47) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

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

__ (48) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108- 78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

X (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (51) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016)

(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

__ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

__ (56) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (57) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31…