75N91021R00043 - Final RFP with Attachments.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92.218 as amended

2. Request for Proposal (RFP) Number:

75N91021R00043

3. Issue Date:

10/15/2021

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Drug Development Support for Cancer Therapy Evaluation Program (CTEP)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Rockville, MD 20850

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 1:00PM EST on 11/16/2021. Offers will be valid for 180 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043."

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: DeChanta Vaughan

PHONE: 240-276-5536

e-MAIL: dechanta.vaughan@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The deadline for receipt of questions concerning this RFP is 2PM EST on October 26, 2021.

Please Note: Mandatory Criteria (See Section M of the RFP)

Secondary Point of Contact:

Pooja Rathore Contracting Officer, Office of Acquisitions, NCI pooja.rathore@nih.gov

RFP Number : 75N91021R00043

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

k. USE OF NON-GOVERNMENT REVIEWERS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

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10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

13. Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements-- Representation (DEVIATION)

14. Past Performance Information

15. HHS Security and Privacy Language for Information and Information Technology Procurements. . . 74

16. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Section 508 accessibility standards for HHS Web Site Content and Communications Materials

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

8. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Drug Development Support for the Cancer Therapy Evaluation Program (CTEP) contract is responsible for: 1) Providing support for the preparation, tracking, submission and distribution of FDA submissions and CTEP drug development related activities, 2) Monitoring and Supporting Adverse Event Reporting, 3) Tracking information regarding investigational anti-cancer agents, 4) Providing technical and general administrative support for investigational agent development and regulatory activities, and 5) Providing a Quality Control Program.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period: 7/1/2022 –6/30/2023 TBD TBD TBD

Option Period(s):

Option Period 1: 7/1/2023 –6/30/2024 TBD TBD TBD

Option Period 2: 7/1/2024 –6/30/2025 TBD TBD TBD

Option Period 3: 7/1/2025 –6/30/2026 TBD TBD TBD

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 4: 7/1/2026 –6/30/2027 TBD TBD TBD

Option Period 5: 7/1/2027 –6/30/2028 TBD TBD TBD

Option Period 6: 7/1/2028 –6/30/2029 TBD TBD TBD

Option Period 7: 7/1/2029 –6/30/2030 TBD TBD TBD

Option Period 8: 7/1/2030 –6/30/2031 TBD TBD TBD

Option Period 9: 7/1/2031 –6/30/2032 TBD TBD TBD

Option A: Phase-in Transition

Option A: Phase-in Transition (3 months) TBD TBD TBD

Option B: Increased Capacity

Option B1: Increased Capacity (12 months) TBD TBD TBD

Option B2: Increased Capacity (12 months) TBD TBD TBD

Option B3: Increased Capacity (12 months) TBD TBD TBD

Option B4: Increased Capacity (12 months) TBD TBD TBD

Option B5: Increased Capacity (12 months) TBD TBD TBD

Option B6: Increased Capacity (12 months) TBD TBD TBD

Option B7: Increased Capacity (12 months) TBD TBD TBD

Option B8: Increased Capacity (12 months) TBD TBD TBD

Option B9: Increased Capacity (12 months) TBD TBD TBD

Option B10: Increased Capacity (12 months) TBD TBD TBD

Option C: Phase-out Transition

Option C: Phase-out Transition (3 months) TBD TBD TBD

Total

[Base Period and Option(s)]

TBD TBD TBD

ARTICLE B.3. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $TBD.

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN, Task, Number, or Description

Start Date of Period or Increment of

Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

[Total] [Total] [Total]

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*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $TBD .

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

f. Payment of fee shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

Indirect Rate Ceiling - The Government reserves the right to negotiate a ceiling rate for all Indirect Rates proposed.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. 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 10/15/2021, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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."

Checklists to ensure appropriate formatting can be found at HHS Section 508 Accessibility Checklists. Document or document-type specific testing shall serve in lieu of the Section 508 Annual Report for Vendors, which is located at:

https://www.itic.org/policy/accessibility/vpat . In addition, we refer the offerors to the following two GSA Section 508 pages for guidance on developing electronic documents for accessibility and Section 508-conformance:

• GSA Section508.gov. Best Practices: https://www.section508.gov/best-practices

• GSA Section508.gov. Create Accessible Electronic Documents: https://www.section508.gov/content/build/ createaccessible-documents

The offeror shall use the relevant or respective checklist as a Section 508 report for each document it submits per file type (e.g., Microsoft Word, Microsoft Excel, PDF, etc.) at the end of the year, in lieu of the Section 508Annual Report for Vendors.

a. Technical Progress Reports In addition to those reports required by the General Provisions and other terms of this contract, the Contractor shall prepare and submit the following reports to the NCI Project Officer and/or NCI Contracting Officer in the manner stated below. The specific format of each report shall be approved by the COR. The reports shall be accurate, complete and free of grammatical and typographical errors with correct formatting.

1. Monthly IND Status Report

The Contractor shall prepare and submit a report every month on the status of Anticipated INDs and a Potential IND Withdrawal list. The Anticipated INDs list shall record all IND related information received by the Contractor and the receipt date. This list shall also note the remaining information necessary to prepare the IND draft. The Potential IND Withdrawal list shall record INDs nearing the end of their lifecycle based on the remaining active protocols. This list shall note the remaining protocol(s), their status and comments regarding any conditions to be met prior to moving forward. The report shall be due by noon the business day prior to the monthly IND status meeting.

2. Monthly Contract Status Report

The Contractor shall prepare and submit an accurate monthly contract status reports highlighting the activities of the previous month. The monthly status report shall be submitted in a bookmarked and navigable PDF format. A message to approved CTEP recipients of the report will be sent an E-mail notice with a link to the report when a new report is available on SharePoint.

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a. The report shall Include a written summary and in tabular form, information on the status and quantity of:

● Active INDs, protocol phase and protocol status

● IND status reported cumulative by year (active, filed, withdrawn, etc.)

● FDA Annual Reports and DSURs

● INDs submitted and withdrawn

● CDRH Submissions by type

● Number of protocol amendments and FDA submissions processed

● Investigator's Brochures

● FDA correspondence tracking

● Project Team Application Announcements

● LOIs received reported cumulative by month and year

● Agreements related activity

● Ad-hoc and Non-Routine Tasks and the level of effort required to complete them

● New and updated CAEPRs

● Biomarker Review Committee support activities

● Meeting minutes support

● Safety Action Letters

b. The report shall include in tabular and graphical form information on the status and quantity of:

● Totals and types of Adverse Event Reports received and processed

● Distribution of AEs amongst IDB staff

● HelpDesk activities for clinical sites and pharmaceutical collaborators

● Pharmaceutical collaborator report activity

● Definition of terms for Adverse Event processing

c. The report shall include changes in contract staffing.

d. The monthly report shall be due on or before the 15th day following each monthly reporting period, except for months in which an annual report is due.

3. Ad hoc Intermediate Status Report

The Contractor shall prepare ad hoc intermediate technical reports as per the COR’s request. The report shall include, but not be limited to, contract fund status, Active IND analysis and the status of pending tasks.

4. Annual Contract Report

The Contractor shall prepare and submit an accurate annual contract status report highlighting the activities of the previous contract year. The annual contract report shall be submitted in a bookmarked and navigable

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PDF format. A message to approved CTEP recipients of the report will be sent an E-mail notice with a link to the report when a new report is available on SharePoint.

The report shall Include a written summary and in tabular form, information on the status and quantity of:

● Active INDs, protocol phase and protocol status

● IND status reported cumulative by year (active, filed, withdrawn, etc.)

● FDA Annual Reports and DSURs

● INDs submitted and withdrawn

● CDRH Submissions by type

● Number of protocol amendments and FDA submissions processed

● Investigator's Brochures

● FDA correspondence tracking

● Project Team Application Announcements

● LOIs received reported cumulative by month and year

● Agreements related activity

● Ad-hoc and Non-Routine Tasks and the level of effort required to complete them

● New and updated CAEPRs

● Biomarker Review Committee support activities

● Meeting minutes support

● Safety Action Letters

● The report shall include in tabular and graphical form information on the status and quantity of:

o Totals and types of Adverse Event Reports received and processed o Distribution of AEs amongst IDB staff o HelpDesk activities for clinical sites and pharmaceutical collaborators o Pharmaceutical collaborator report activity o Definition of terms for Adverse Event processing

● The report shall include changes in contract staffing

● The annual report shall be due on or before the 30th calendar day following the end of each contract year.This report shall not be due when the final report is due.

5. Final Report

The Contractor shall prepare and submit a final report. The final report shall document and summarize the outcome for the entire contract on a task by task basis, as well as overall results for the total contract period.

This report shall be in sufficient detail to explain comprehensively the work achieved and trends in workload. A draft final report shall be submitted 15 calendar days before the expiration date of the contract. The final report shall address comments made on the draft final report and be submitted on or before the expiration date of the contract. The final report shall be submitted in a bookmarked and navigable PDF format. A message to approved CTEP recipients of the report will be sent an E-mail notice with a link to the report when a new report is available on SharePoint.

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6. Phase-In and Phase-Out Plans

The Contractor awardee shall submit the Final Phase-in plan to the COR and the Contracting Officer within 7 calendar days of the award of the contract. Upon review and approval by the Contracting Officer and COR of the Contractor’s Phase-in plan, the Contractor shall meet with the predecessor Contractor for briefings on execution of the Phase-In plan. The successor Contractor shall work with the predecessor Contractor to ensure that work operations are fully understood and continuity of operations are maintained through the transition.

The Contractor shall prepare and submit a draft Phase-Out Transition Plan to the COR and the Contracting Officer 150 calendar days prior to the expiration date of the contract and upon notice from the CO. The plan shall describe the Contractor's strategy for transferring work from this contract to a successor contract, in the event a final transition is required. The Phase-Out plan must include plans for transfer of policies and procedures;

transfer of relevant files, records, materials, and data; transition of all activities, and transition of all applications, as appropriate. The Draft Phase-Out Transition Plan shall include provision by the Contractor of accurate and complete data files and pertinent documentation. The draft Phase-Out Transition Plan shall be revised upon receipt of the review and comments of the COR and the final Phase-Out Transition Plan shall be submitted 120 calendar days prior to the contract expiration.

7. Summary of Salient Results

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 contract.

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&node=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. Source Code and Object Code

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.

3. Information and Physical Security Deliverables

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A. Authority to Operate (ATO)- 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 assist the NCI in preparation of deliverables required to complete the ATO within the specified timeline(s) by NCI. The Contractor is not responsible for the ATO since the system is hosted internally by NCI.

B. Position Sensitivity Designations – All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[X] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

C. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster of Employees Requiring Suitability Investigations -

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

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g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

D. Notice of Departing Employees

The Contractor (and/or any subcontractor) shall notify the CO, COR and system ISSO within 24 hours of receiving the notification from the departing employee.

E. Employee Separation Checklist

The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/ Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. Non-Disclosure Agreement (NDA)

Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) upon request.

G. Training Records The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR upon request.

4. Annual VPAT

The Contractor shall submit an annual VPAT in accordance with the schedule set forth by the Contracting Officer (CO)/ Contracting Officer's Representative (COR). The Applicable VPAT is the VPAT 2.4 508 or most recent version. The VPAT and Instructions for completing the report are available at: https://www.itic.org/ policy/accessibility/vpat.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980

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(Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

All reports shall be sent to the following: To be determined at the time of award.

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer's Representative, COR is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute 9609 Medical Center Drive Rockville, MD 20850

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is not applicable to this contract.

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 7/1/2022 through 6/30/2023.

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

Option Option Period of Performance

Option Period 1 7/1/2023 – 6/30/2024

Option Period 2 7/1/2024 – 6/30/2025

Option Period 3 7/1/2025 – 6/30/2026

Option Period 4 7/1/2026 – 6/30/2027

Option Period 5 7/1/2027 – 6/30/2028

Option Period 6 7/1/2028 – 6/30/2029

Option Period 7 7/1/2029 – 6/30/2030

Option Period 8 7/1/2030 – 6/30/2031

Option Period 9 7/1/2031 – 6/30/2032

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below.

Technical Reports:

Item Description Delivered to Due Date

1. Monthly IND Status Report COR By noon the business day prior to the monthly IND status meeting.

2.

Monthly Contract Status Report

CO, COR, and posted to COR specified CTEP SharePoint site and authorized distribution list

15 calendar days following each reporting period.

3. Ad hoc Intermediate Status Reports

COR As requested by the COR.

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Item Description Delivered to Due Date

4.

Annual Contract Report CO, COR, designated distribution list and posted to specified CTEP SharePoint site

On or before the 30th calendar day following the end of each contract year.

5.1. Draft Final Report CO and COR 15 calendar days before

the expiration date of the contract.

5.2. Final Report COR and posted to COR

specified CTEP SharePoint site

On or before the expiration date of the contract.

6.1 Phase-In Plan CO and COR Final Plan – within 7 days of

the award of the contract.

6.2 Phase-Out Plan CO and COR Draft Plan – 150 calendar

days prior to the expiration date of the contract. Final Plan – 120 calendar days prior to the contract expiration.

7.

Summary of Salient Results CO and COR On the expiration date of the contract.

8. Source Code and Object Code

CO and COR On the expiration date of the contract.

9. Annual VPAT CO and COR Initial Report – 90 calendar days after contract award.

Annually – 30 calendar days prior to the end of a contract period.

IT Security Deliverables

1. Roster of Employees Requiring Suitability Investigations

COR and CO Due within 14 days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 calendar days of the change.

2. Notification of Departing Employee

COR and CO

The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 24 hours of Contract staff notice.

3. Employee Separation Checklist

The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist within 2 days

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Item Description Delivered to Due Date of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

4. Contractor – Employee Non-Disclosure Agreements (NDA)

Prior to an employee performing any work under contract. All documentation shall be made available to the CO and/or COR upon request.

5. Training Records COR and CO All documentation shall be made available to the CO and/or COR upon request.

b. The above items shall be addressed and delivered as follows:

Addressee Deliverable Item No.

Contracting Officer’s Representative (COR)

(To be named)

Technical Reports (1 & 3)

Contracting Officer (CO) and Contracting Officer’s Representative (COR)

(To be named) ncibrancheinvoices@mail.nih.gov

Technical Reports (2, 4-9)

IT Security Deliverables (1-5)

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide TBD direct labor hours . The labor hours Exclude vacation, holiday, and sick leave. These labor hours Exclude subcontractor labor hours . It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Labor Category

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10

Professional Other Professional

Support Totals

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

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c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of hours by which the number of direct labor hours furnished is less than the number of direct labor hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

To be specified at the time of award.

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

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

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

The Government may unilaterally change its COR or Alternate COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

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 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.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD TBD

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

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a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors , which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer's Representative:

Approving Official: Contracting Officer

Name- TBD Email Address- TBD

Contracting Officer's Representative

Name- TBD Email Address- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https:// ofm.od.nih.gov/Pages/Customer-Service.aspx .

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

One courtesy copy of the original invoice shall be submitted electronically as follows:

The Central Point of Distribution:

NCI OA Branch E - ncibrancheinvoices@mail.nih.gov

Invoices shall be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/ Vendors , which is included as an attachment in Section J of this contract.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute .

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact

- 22 -the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is:

Drug Development Support for the Cancer Therapy Evaluation Program (CTEP)

g. Contract Line Items as follows:

Line Item # Line Item Description

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

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(End of Clause)

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on the anniversary date of the contract .

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

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

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of…