75N91019D00024_Mod P00004_Redacted.pdf

75N91019D00024 through Mod P00004

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. SPONSORING AGREEMENT

ARTICLE B.3. PRICES/COSTS

ARTICLE B.4. ADVANCE UNDERSTANDINGS

ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. ORDERING PERIOD

ARTICLE F.2. DELIVERIES

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVES (CORs) ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

ARTICLE G.3. TASK ORDER PROCEDURE

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT (APPLICABLE TO COST-REIMBURSEMENT TASK ORDERS ONLY)

ARTICLE G.5. INVOICE SUBMISSION (APPLICABLE TO FIXED PRICE TASK ORDERS ONLY)

ARTICLE G.6. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013)

ARTICLE G.7. INDIRECT COST RATES

ARTICLE G.8. GOVERNMENT PROPERTY

ARTICLE G.9. ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTY

ARTICLE G.10. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

ARTICLE H.2. HUMAN SUBJECTS

ARTICLE H.3. HUMAN SUBJECTS

ARTICLE H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

ARTICLE H.5. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

ARTICLE H.6. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN NIH-FUNDED

CLINICAL TRIALS

ARTICLE H.7. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION

ARTICLE H.8. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

ARTICLE H.9. CERTIFICATE OF CONFIDENTIALITY

ARTICLE H.10. SINGLE INSTITUTIONAL REVIEW BOARD (sIRB) ARTICLE H.11. PLAN FOR SINGLE INSTITUTIONAL REVIEW BOARD (sIRB) ARTICLE H.12. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS ARTICLE H.13. INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN AS PARTICIPANTS IN RESEARCH

INVOLVING HUMAN SUBJECTS

ARTICLE H.14. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV ARTICLE H.15. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

ARTICLE H.16. HIV ANTIRETROVIRAL TREATMENT TRIALS

ARTICLE H.17. HUMAN MATERIALS

ARTICLE H.18. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

ARTICLE H.19. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES

(Including Human Gene Transfer Research)

ARTICLE H.20. REMITTANCE PROCEDURES FOR SALE OF RESEARCH SUBSTANCES AND LIVING

ORGANISMS

ARTICLE H.21. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

ARTICLE H.22. DATA SHARING IN GENOME-WIDE ASSOCIATION STUDIES (GWAS)

ARTICLE H.23. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING

FROM NIH-FUNDED RESEARCH

ARTICLE H.24. DUAL USE RESEARCH OF CONCERN

ARTICLE H.25. NEEDLE EXCHANGE, HHSAR 352.270-12 (December 2015)

ARTICLE H.26. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.27. CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON FUNDING OF

HUMAN EMBRYO RESEARCH, HHSAR 352.270-13 (December 2015)

ARTICLE H.28. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

ARTICLE H.29. PRIVACY ACT, HHSAR 352.224-70 (December 2015) ARTICLE H.30. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)

ARTICLE H.31. ANIMAL WELFARE

ARTICLE H.32. INTRODUCTION OF RODENTS AND RODENT PRODUCTS (Applicable to related activities at the NCI-Bethesda Campus only)

ARTICLE H.33. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

ARTICLE H.34. OMB CLEARANCE

ARTICLE H.35. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.36. GUN CONTROL

ARTICLE H.37. OPTION PROVISION – ORDERING PERIOD

ARTICLE H.38. SUBCONTRACTING PROVISIONS

ARTICLE H.39. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS ARTICLE H.40. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-74 (December 2015)

ARTICLE H.41. COMMUNICATIONS MATERIALS AND SERVICES

ARTICLE H.42. STORAGE FACILITY REQUIREMENTS AND CERTIFICATION

ARTICLE H.43. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL

ARTICLE H.44. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

ARTICLE H.45. CONFIDENTIALITY OF INFORMATION

ARTICLE H.46. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

ARTICLE H.47. PUBLICATION AND PUBLICITY

ARTICLE H.48. REVIEW OF MANUSCRIPTS

ARTICLE H.49. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.50. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

ARTICLE H.51. SHARING RESEARCH DATA

ARTICLE H.52. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

ARTICLE H.53. HIGHLY PATHOGENIC AGENTS

ARTICLE H.54. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.55. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

ARTICLE H.56. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

ARTICLE H.57. REGISTRATION FEES FOR CONFERENCES, WORKSHOPS AND MEETINGS

ARTICLE H.58. REGISTRATION FEES FOR NIH SPONSORED SCIENTIFIC, EDUCATIONAL, AND

RESEARCH-RELATED CONFERENCES

ARTICLE H.59. GUIDELINES FOR INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH

DISABILITIES IN NIH-SUPPORTED CONFERENCES

ARTICLE H.60. USE OF FUNDS FOR PROMOTIONAL ITEMS

ARTICLE H.61. CONTINUITY OF SERVICES

ARTICLE H.62. OBSERVANCE OF FORT DETRICK REGULATIONS

ARTICLE H.63. ORGANIZATIONAL CONFLICTS OF INTERESTS

ARTICLE H.64. EXCHANGE OF CONFIDENTIAL INFORMATION AND RESEARCH MATERIALS

ARTICLE H.65. TELEWORK

ARTICLE H.66. NOVATION

ARTICLE H.67. HAZARDOUS MATERIALS

ARTICLE H.68. PERFORMANCE GUARANTEE AGREEMENT

ARTICLE H.69. RESPONSIBLE CORPORATE OFFICIAL

ARTICLE H.70. SEPARATE CORPORATE ENTITY

ARTICLE H.71. PRODUCT LIABILITY INSURANCE AND LICENSING (Applicable to cGMP projects)

ARTICLE H.72. TECHNOLOGY TRANSFER

ARTICLE H.73. SPECIAL CONTRACT REQUIREMENTS FME/EHS

ARTICLE H.74. NIH RETURN TO PHYSICAL WORKSPACES – CORONAVIRUS DISEASE 2019 (COVID-19)

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1.A GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT

CONTRACT

ARTICLE I.1.B GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT

ARTICLE I.1.C GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE RESEARCH AND DEVELOPMENT

CONTRACT

ARTICLE I.1.D GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE SERVICE CONTRACT

ARTICLE I.2 AUTHORIZED SUBSTITUTIONS OF CLAUSES

ARTICLE I.3 ADDITIONAL CONTRACT CLAUSES

ARTICLE I.4 ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

ARTICLE I.5 SERVICE CONTRACT LABOR STANDARDS AND LABOR LAWS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall, in accordance with the provisions of this contract, support the missions and programs assigned under contract with the National Cancer Institute and manage and operate the National Cancer Institute’s Federally Funded Research and Development Center (FFRDC)/Frederick National Laboratory for Cancer Research (FNLCR). The purpose of the FFRDC is to provide a unique biomedical research and development resource for the development of new technologies and the translation of basic science discoveries into novel agents for the prevention, diagnosis, and treatment of cancer, Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), and other diseases in support of the NCI, NIAID, other NIH ICs and other government agencies. The FFRDC serves as a flexible, quick-response mechanism to accomplish the most urgent national/global health initiatives for the NCI/NIH and other government agencies.

ARTICLE B.2. SPONSORING AGREEMENT

The Frederick National Laboratory for Cancer Research (FNLCR) is Government-Owned Contractor- Operated (GOCO), Federally Funded Research and Development Center (FFRDC), sponsored by NIH under contract by NCI and established in accordance with Federal Acquisition Regulation (FAR) 35.017.

This sponsoring agreement between NCI/NIH and the FNLCR facilitates the long-term relationship, establishes the FNLCR's mission, and ensures periodic reevaluation of the FFRDC to ensure special research and development needs continue to be met.

In accordance with FAR 35.017-1(a), a sponsoring agreement may take various forms and may be included in a contract between the Government and the FFRDC. This Article B.2, which references and incorporates other terms and conditions set forth in the contract, constitutes the sponsoring agreement for this FFRDC.

In accordance with FAR 35.017-1(e), the term of this sponsoring agreement will not exceed 5 years, but can be renewed, as a result of periodic review, in increments not to exceed 5 years. This sponsoring agreement is scheduled for periodic reevaluation prior to May 2021 to ensure special research and development needs continue to be met.

A. Statement of Purpose and Mission of the FFRDC

The purpose of the FNLCR is to provide a unique biomedical resource for the development of new technologies and the translation of basic science discoveries into novel agents for the prevention, diagnosis, and treatment of cancer, Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), and other diseases. The FFRDC’s contract Statement of Work (SOW) encompasses various research support programs, projects, and activities including, but not limited to: basic, translational, clinical and animal research and research support.

B. Provisions for Orderly Termination or Nonrenewal of the Agreement, Disposal of Assets, and Settlement of Liabilities

This contract and the Contractor’s operation of the FNLCR are based on expectations of a long-term and continuing relationship between the parties. NIH/NCI will use its best efforts to inform the Contractor as far as possible in advance if it concludes that such a long-term relationship is no longer in the best interest of the Government however, the notification requirements at FAR 52.217-9(a) remain unchanged.

This Contract contains the general provisions and other special provisions/clauses which describe the process for orderly termination or nonrenewal of this Agreement including disposal of any assets and settlement of liabilities. Responsibility for capitalization of the FFRDC and ownership of the assets rests with the Government.

In the event of termination of the sponsoring agreement and resultant termination of the contract, the Government shall ensure the minimum quantity stated in Article B.3. has been paid to the Contractor. Additionally, task orders issued hereunder are subject to termination provisions.

In the event of such termination or of the expiration or non-renewal of this Agreement and contract, all items that were furnished by the Government or purchased by the Contractor and charged to the contract are the property of the Government and will be managed/disposed of in accordance with FAR 52.245-1.

In the event of termination or nonrenewal of the sponsoring agreement the Government shall deduct from the amount due to the Contractor all unliquidated advance payments as required by FAR clause 52.232-12. In the event of termination or nonrenewal, ownership and management of all work in process, intellectual property, CRADA funds, royalty funds, rights to uncollected royalties and related records shall be transferred to a successor Contractor or the Government. In the event of termination, all source code and object code developed, modified, or enhanced under this Contract shall remain in place at the FNLCR unless different disposition is directed by the Contracting Officer.

In addition to the provisions identified herein, the Government may recognize a third party as the successor in interest to the Contract when the third parties' interest in the Contract arises out of the transfer either of all the assets of the Contractor or all of that part of the Contractor's assets involved in the performance of the Contract. In the event of a successor in interest it is the Government's intent that all assets and liabilities would novate to the successor including all subcontracts having anticipated completion dates beyond the expiration date of the Contract.

The Contractor shall transfer funds to the successor Contractor(s) in an amount equal to the dollar value of the accrued vacation liability. The successor Contractor shall assume the Employee Savings

Plan and the Defined Benefit Retirement Plan and the incumbent 401(k) Plan. The successor Contractor shall assume the Plans' respective trusts and assets and become responsible for any and all obligations to participants in the Plans as a result of the transfer in total to the successor Contractor of assets and liabilities of the plans. The amount of pension liability shall be based on the most recent actuarial calculation completed by the plan actuary. The amount of the assets that shall be transferred by the Contractor to the successor Contractor shall equal the assets in the Plans' respective Trusts. For purposes of thisContract, the term “successor contractor” shall be understood and agreed to include the incumbent contractor awarded a follow-on contract to perform substantially the same work required under this contract.

The Government shall approve assets and liabilities as being properly calculated in compliance with applicable Cost Accounting Standards.

C. Retained Earnings Identification, and Plan for Use and Disposition

The Contractor shall identify all retained earnings on a periodic basis, but not less than once per year, including a plan for the use and disposition in the events of termination or nonrenewal of the Agreement. In the context of this clause, “retained earnings” shall be defined as those items identified in section (b) of this Article including ownership and management of all work in process, intellectual property, Government CRADA funds, royalty funds and uncollected royalties. It is understood and agreed that “Retained Earnings” expressly excludes any and all fixed fee earned by the Contractor under this contract.

D. Prohibition Against Competition

The Contractor shall not compete with any non-FFRDC concern in response to a Federal agency request for proposal for other than the operation of this FFRDC. This prohibition is not applicable to the Contractor's parent organization, if any, or other subsidiary of the parent organization in its non-FFRDC operations. This prohibition does not apply to requests for information, qualifications or capabilities as those can be answered unless otherwise restricted by the Contracting Officer.

E. Accepting Work from Other than the Sponsor

The Government, not the contractor, has complete discretion about whether to accept work from other than NIH. Therefore, the Contractor shall not accept work from a nonsponsoring Federal agency, i.e., an agency other than the NIH, unless accepted by the Contracting Officer’s Representative (COR) and approved by the Contracting Officer. Work from nonsponsoring Federal agencies may be accepted by the COR and approved by the Contracting Officer only if such work falls within the purpose, mission, general scope of effort, or special competency of the FFRDC. Furthermore, any such use of the FFRDC by a nonsponsoring Federal agency must be in accordance with 48 CFR 17.502-2, The Economy Act. Prior to acceptance by the COR and approval by the Contracting Officer, the nonsponsoring Federal agency shall provide all information and documentation requested by the COR and Contracting Officer, including but not limited to confirmation that the requested work would not place the FFRDC in direct competition with domestic private industry.

F. Advance Understandings

Cost elements which require advance agreement are addressed herein under Article B.4. Advance Understandings.

ARTICLE B.3. PRICES/COSTS

This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ 350,000 (minimum) nor more than a total of $ 6,600,000,000 (maximum) for successful performance of this contract.

A. The minimum and maximum set forth in this ARTICLE will cover the ordering period June 26, 2019 through June 25, 2024, should all options be exercised.

B. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

A. Indirect Rates and Labor Rate Ranges

1. Establishment of Indirect Rates

Indirect costs are funded in accordance with Section J, Attachment 1; however, the Contractor shall not bill or be reimbursed for indirect costs until such time as an indirect cost proposal has been submitted to the cognizant office responsible for negotiating the indirect cost rates, unless a temporary billing rate(s) has been included herein. Unless otherwise specified below, the indirect cost rate proposal shall be submitted no later than thirty (30) days after the date of contract award.

The Contractor may bill indirect costs and direct labor rates at the temporary billing rates specified in Section J, Attachment 1, until such time as indirect costs have been established, provided, that the Contractor's indirect cost proposal is submitted to the cognizant office responsible for negotiating indirect costs no later than thirty (30) days after the date of contract award. If, the indirect cost proposal is not submitted in a timely manner, any temporary indirect costs billed after this due date will be suspended until such time as the indirect cost proposal is submitted.

2. Management of Indirect Rates

The Contractor is responsible for managing all indirect rates as set forth under Article B.4.A.1.

This responsibility includes operating and managing all indirect functions and resources required in support of the contract and Task Orders awarded thereunder. Such resources include, but are not limited to, both fixed and variable indirect employees, budgets and other costs required in support of indirect operations.

The following functions are considered indirect; prime contract administration, project management oversight, finance and project control, accounting, human resources, support of contractor business enterprise systems, technology transfer, partnership development, executive leadership, procurement, subcontract administration, export control, public affairs and communications, compliance and risk management, clinical regulatory oversight, occupational health, safety officers, conference planning and travel administration. Staff in these functional areas ensure operation of the FFRDC in a manner compliant with federal or state legal and regulatory statutes. Liability insurance and all employee benefits are considered indirect costs.

All indirect fixed and variable costs shall be included in submission of any interim indirect billing rates provided to the responsible Contracting Officer for review and approval.

The Contractor shall provide the Government with an annual Operations Plan in the mutually agreed upon format and frequency as a notification. Such plans are provided for informational purposes only and should not include budget information.

B. Insurance

The Contractor is authorized to acquire the following types of insurance coverage subject to Contracting Officer Authorization (COA) except that any insurance required by law shall not require COA. The Contractor is authorized to utilize existing, or to acquire additional insurance coverage required under fixed price task orders in accordance with FAR 52.228-5 as an allowable cost subject to COA except that any insurance required by law shall not require COA.

1. General Liability (both Domestic and International); 2. Automobile Liability; 3. Umbrella/Excess Liability; 4. Fiduciary Bond; 5. Fidelity Bond; 6. Group Travel; 7. Medical Malpractice; 8. Medical Products Liability for Therapeutics, Diagnostics, and Vaccines; 9. Professional Liability-OHS Clinic;

10. Physicians Malpractice; and 11. Leased Facilities.

The allowable costs associated with the insurance coverage authorized above shall not include "mark-up" of any costs, e.g., General and Administrative costs (G&A), allocated from Leidos (Corporate) to the Contractor with respect to acquisition of approved insurance policies covering activities under this contract.

Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way to change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

3. The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

G. Steam Production Plants

It is understood and agreed that Steam Generation (North and South) plants constructed and operated by APS Cognenix on behalf of its parent Potomac Edison, through the Energy Basic Ordering Agreement #97CXS0272A (Delivery Order NCI-2005-07), shall be operated by APS Cognenix pursuant to its subcontract with the Contractor. The Government acknowledges that this project will be viewed as any other “maintained facility” on the NCI- FNLCR campus in accordance with the terms of this contract, and the Contractor assumes no additional liability beyond that provided for by the provisions of this contract, and for the willful misconduct or gross negligence of the Contractor. Remedies for plant failures are outlined in the Delivery Order modification to the Energy BOA identified above and the Feasibility Study proposal included therein. The Contractor has not acquired any additional insurance to cover losses of the steam facility or related losses due to the loss of steam to operating labs at the NCI Campus at Frederick.

H. HPV Serology Standardization Project

The Human Papillomavirus (HPV) Serology Project requirement was funded in part by a gift from the Gates Foundation (the “Foundation”) to NCI. The Contractor and NCI agree that the Project activities shall not involve clinical trials, trials involving human subjects, post-approval studies, field trials involving genetically modified organisms, experimental medicine, or the provision of medical/health services (individually or collectively, “Indemnified Activities”). The Contractor represents and warrants that it shall not engage in and will ensure that no funds are used for any Indemnified Activities in fulfillment of its obligations under the Project.

I. Retirement Programs

The Contractor shall maintain retirement programs defined below and consistent with respective plan documents for plan participants working at the Frederick National Laboratory for Cancer Research (FNLCR), a Government Owned – Contractor Operated (GOCO), Federally Funded

Research and Development Center (FFRDC). Retirement Programs A and B, as defined below, exist for the exclusive benefit of Contractor employees of the FNLCR and have been and will continue to be sponsored by the Contractor on behalf of NCI, pursuant to relevant requirements and during the term of the Contract.

Retirement Program A—Defined Benefit Plan & Employee Savings Plan [Legacy 401(k)]

Program A is a Qualified Off-Set Arrangement authorized by the Tax Reform Act of 1986, Pub. L. No. 99-514, Special Rule for Qualified Off-Set Arrangements, Section 1116(f)(5). Program A was adopted effective September 26, 1982 and closed to new entrants effective July 1, 2006 and was amended effective June 27, 2014 to freeze benefit accruals for all participants, other than those who, as of the effective date, either had attained age 55 and 10-years of service or had attained age 65 and 5 years of service (“Grandfathered Participants”). The 2014 plan amendment was not deemed to be a “curtailment of benefits” as that term is defined in CAS 413-30(a)(7), as ongoing plan participants continued to accrue material benefits under Plan A.

Retirement Program B—401(k) Plan

This is a 401(k) Defined Contribution Plan (New 401(k)). It is the sole retirement program available to Contractor employees who accepted an offer of employment on or after July 1, 2006; in addition, active staff who previously participated in Plan A, but failed to qualify with the Grandfathering provisions adopted at the time of the 2014 plan amendment, became eligible to participate in Plan B on June 28, 2014 via the amendment executed on June 9, 2014.

Since program inception, the Government and each Contractor Operator, have agreed and acted accordingly, that the Contractor Operator would sponsor and administer the Defined Benefit Plan on behalf of the Government. With respect to the Defined Benefit Plan, the June 24, 1986 Senate Colloquy to Public Law 99-514 states that, in the case of individuals working at the FNLCR, the employer is the facility itself, without regard to the particular contractor in charge of facility operations.

It is the mutual intent of the parties that the FNLCR Retirement Programs A and B continue as ongoing retirement programs over the term of this contract. The parties agree that this contract, because it relates to operating a FFRDC, is the only cost objective to which the costs of Retirement Programs A and B will be allocated for purposes of government contract cost accounting requirements, including CAS 412 and 413. Further, the parties agree that all allowable costs related to Program A and B, including all post-curtailment and plan termination costs, are allocable 100% to the applicable task order(s) issued pursuant to this contract. Consistent with this intent, the Contractor will continue to sponsor and administer Retirement Programs A and B during the term of this contract. The parties’ responsibilities regarding Retirement Programs A and B under this contract, including Government reimbursement to Contractor for all allowable program costs, i.e., costs of the on-going plan (e.g., costs of actuarial gains and losses and plan maintenance costs); costs of plan funding (e.g., prepayment credits); costs of administering (e.g., all costs, such as litigation costs, relating to plan participant rights under a program); or costs of terminating

Retirement Programs A and/or B, will be specifically addressed in the first NCI Operational Task Order issued under the contract. Based on mutual agreement of the parties to enact a termination of either Plan A and/or Plan, such termination will be executed through award a stand alone task order.

J. Fixed Fee The following represents the negotiated fixed fee to be applied to all Cost Plus Fixed Fee Task Orders issued hereunder: . The parties agree that a fixed fee of shall be applied to the estimated cost of each task order at the time of obligation. The fixed fee will not vary based on actual costs incurred unless the Contracting Officer modifies the task order to add new work.

K. The Contractor shall obtain Contracting Officer approval prior to taking the following actions. The following is a non-exclusive list of applicable actions:

1. All name changes to Leidos Biomedical Research, Inc. labs, programs, centers, etc.

2. All space assignments

L. It is agreed and understood that all number of days stated within this contract are assumed to be business days unless otherwise specified.

M. Determination of Exceptional Circumstances In accordance with FAR 52.27.304-1(b) and 27.303(e)(1)(ii), the National Cancer Institute requested and received approval for the use of deviated FAR clauses in this contract. The following deviated FAR clauses are incorporated by reference and are included in full text as Section J, Attachment 3.

FAR 52.227-13 (Deviation) Patent Rights--Ownership by the Government (April 2017) [Patent Rights-Prime Contractor];

FAR 52.227-11 (Deviation) Patent Rights--Ownership by the Contractor (April 2017) [Conditional Ownership by the Contractor--Contractor CRADAs]; and, FAR 52.227-11 (Deviation) Patent Rights--Ownership by the Contractor (April 2017) [Patent Rights-Use of Third-party Technology and Information or Intramural/repurposed Drug Development by Subcontractors].

ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS

A. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

1. Conferences and meetings;

Defined as: All Symposia, Seminars, Conferences and Meetings as per the latest guidance in the HHS Efficient Conference Spending Policy and incorporated guidance on HHS Policy on Use of

Appropriated Funds for Conferences and Meeting Space.

2. Food for Meals, Light Refreshments & Beverages;

3. Promotional Items including, but not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees;

4. Acquisition, by purchase or lease, of any interest in real property;

5. Special rearrangement or alteration of facilities; See Article H.73.B, Work Orders.

6. Foreign travel All foreign travel requires Contracting Officer Authorization (COA). All travel costs exceeding those authorized under the Federal Travel Regulations (FTR) must be justified in writing to the Contracting Officer for Contracting Officer Authorization:

No funds provided under this contract shall be used for reimbursement of travel expenses incurred by Government employees. Neither shall contract funds provided under this contract be used for travel of other non-contractor employees without the prior approval of the Contracting Officer. The only exceptions are travel associated with subcontracts based on approved purchase requests that include costs for travel.

In the event a Contractor employee requesting travel is also employed on another contract, the Contractor must identify the other contracts by Agency and contract number in a letter to the Contracting Officer. Such letter shall include a written statement from the cognizant Contracting Officer of the other Agency that the employee's travel is for the benefit of this contract and therefore no charges for time or travel will be made to another contract;

7. Consultant Costs;

8. Subcontract Costs;

9. Accountable Government Property 1) “capital equipment” (defined as non-expendable personal property with an acquisition cost of $5,000 or more) and 2) "sensitive items" (defined as items of personal property supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value;

10. Dispensation of Government furnished, or Contractor acquired property under this contract to include:

a. Sale of Scrap

b. Sale and Barter

c. Transfer of Property

d. Educational Institution Screening Request

e. Educational Institution Donation Request

f. Relief of Accountability/Abandonment (including notification of proper disposal per federal, state, and local laws when property has been exposed to radiation)

g. Relief of Accountability – Government Fleet Vehicles;

11. Severance pay, early retirement, or voluntary termination incentives not otherwise provided for in the Contractor’s Human Resource policy;

12. Acquisition, by purchase or lease, of any motor vehicle;

13. For any proposed legal instrument between the Contractor and its parent organization including all businesses in which the parent organization is known to have a controlling interest, including but not limited to affiliates and subsidiaries;

14. Changes/renewals or additions to insurance coverage;

15. Request for guest researcher;

16. Technology transfer agreements:

a. cCRADA

b. mCRADA

c. Additions to Technical Services Agreement (TSA) list

d. Collaboration agreement

e. Beta-test agreement.

17. Travel Costs

The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) § 31.205-46, Travel Costs.

18. Independent Research No independent research, with the exception of the LDER program, will be performed under this contract without prior authorization from the Contracting Officer.

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, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated June 26, 2019, attached hereto and made a part of this Contract (See SECTION J, Attachment 4).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

Task Orders issued hereunder will identify task order specific reporting requirements.

A. Technical Progress Reports (Applicability specified at task order level)

In addition to the required reports set forth elsewhere in this contract, the preparation and submission of regularly recurring Technical Progress Reports will be specified at the task order level. 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 the reports will be determined within each task orders.

[Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

1. Reporting on Dual Use Research of Concern (Applicability specified at task order level)

a. Progress Report

For work involving an agent or toxin identified in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern or "DURC policy" (see http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf), the contractor shall report the following information in the Annual/Semi-Annual/Quarterly/Monthly Progress report:

i. Identification of agents or toxins that are listed in the DURC policy and used in research funded in this contract, and;

ii. Proposed modifications, if any, to the risk mitigation plan.

b. Special Notifications

The contractor shall report to the Contracting Officer's Representative, within 30 calendar days of:

i. Any change in the status of the DURC project funded under this contract (including whether the research is determined by the contractor's institutional review entity to no longer meet the definition of DURC);

ii. Details of any changes to risk mitigation plans (such changes need to be pre-approved by the Contracting Officer's Representative), or;

iii. Instances of noncompliance with the DURC policy, as well as mitigation measures undertaken by the contractor to prevent recurrences of similar noncompliance.

2. Annual Technical Progress Report for Clinical Research Study Populations (Applicability specified at task order level)

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this task order. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J, Attachment 5 of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website:

http://grants.nih.gov/grants/funding/women min/women min.htm .

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender, race and/or ethnicity.

3. Final Report (Applicability specified at task order level)

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. A/An [Annual/Semi- Annual/Quarterly/Monthly] report will not be required for the period when the Final Report is due.

4. Summary of Salient Results (Applicability specified at task order level)

As identified in each task order, as applicable, the Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the task order.

5. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents (Applicability specified at task order level)

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each [Annual/Semi-Annual/Quarterly/Monthly] Progress Report:

a. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

b. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

i. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

ii. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html ) or listed on the U.S. National Select Agents Registry restricted experiments website ( http://www.selectagents.gov/index.html );

iii. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

iv. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each [Annual/Semi-Annual/Quarterly/Monthly] Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each [Annual/Semi- Annual/Quarterly/Monthly] Progress Report.

6. Cost, Schedule, Performance Reports (Applicability specified at task order level) The Contractor shall submit recurring cost, schedule, performance reports. The frequency and specific content of these reports will be determined per task order for specific task order requirements. The reports shall comprehensively describe cost, schedule, and performance metrics and issues. The reports shall include the following information:

a. An estimate at completion (EAC) shall be calculated through the reporting period. Current spending (and staff level-of-effort, as applicable) through the reporting period shall be compared to estimated spending rate (and staff level-of-effort set at the beginning of the project/task order. Issues related to spending rate (ahead of spending rate/staff level-of-effort or behind) shall be discussed at a summary level.

b. Current schedule/milestones through the reporting period shall be compared to the estimated schedule/milestones set at the beginning of the project/task order. Issues related to schedule (ahead of schedule or behind) shall be discussed at a summary level.

c. Performance issues shall be discussed and linked to cost/schedule issues. Potential risks identified during the performance of the project/task order are discussed as they are encountered or mitigated. Proactive solutions to performance issues should also be discussed.

B. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&no de=45:1.0.1.1.51&idno=45 . See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Report of USDA-Designated Biobased Products

In accordance with FAR clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, the contractor shall report to https://www.sam.gov any USDA-designated biobased products purchased during the period of October 1-September 30 of each contract year. This report shall be submitted no later than October 31 of each year during contract performance and at the end of contract performance.

3. Source Code and Object Code

All source code and object code developed, modified, and/or enhanced under this contract is the property of the Government. Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

4. Information and/or Physical Security

The Contractor shall submit the following reports as required by the HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS Article in SECTION H of this contract and in accordance with HHS Enterprise Performance Life Cycle Policy, https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf. The Contractor shall comply with the below requirements for all new systems and report on the base IDIQ Contract for contract-wide systems/requirements and per task order for specific task order systems/requirements. For any legacy systems, applications, and computers, the Contractor shall document their plan for bringing them into compliance and submit this plan to the Government within 30 calendar days of contract award. For both existing legacy systems and new systems, the Contractor shall document non-compliance issues in accordance with NIST guidance.

a. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s). The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

b. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package in accordance with NIH Enterprise Life Cycle (EPLC) requirements prior to the ATO. The following SA&A deliverables are required to complete the SA&A package.

i. System Security Plan (SSP) - due in accordance with NIH Enterprise Life Cycle (EPLC) requirements prior to the ATO. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP no less than annually thereafter.

ii. Security Assessment Plan/Report (SAP/SAR) - due in accordance with NIH Enterprise Life Cycle (EPLC) requirements prior to the ATO. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

iii. Independent Assessment - due in accordance with NIH Enterprise Life Cycle (EPLC) requirements prior to the ATO. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s).