N01CN77019-18.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:

N01CN77019-18

3. Issue Date:

May 7, 2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : PREVENT Cancer Preclinical Drug Development Program

6. ISSUED BY:

National Institutes of Health National Cancer Institute Office of Acquistions Treatment and Support Branch 8490 Progress Drive, Suite 400 Frederick, MD 21701

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, "eCPS Proposal Delivery Instructions," until 3:00 PM Eastern Daylight Time (EDT) on June 21, 2018. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043. The deadline for receipt of questions is June 14, 2018 at 2:00 PM EDT per the instructions in Section L.1 General Instructions.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "eCPS Proposal Delivery Instructions." 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 subparagraph (c) (3) of FAR Clause 52.215-1, "Instructions to Offerors--Competitive Acquisitions" and 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 http://www.sam.gov

11. FOR INFORMATION CALL: Nicole Belanger

PHONE: (301) 624-8754

e-MAIL: belangern@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Submit all questions in writing to belangern@mail.nih.gov.

Responses to questions will be provided in Amendments to the Solicitation. Questions received after the deadline (stated above in Box 8 above) may not be addressed.

Nicole Belanger Contracting Officer, TSB, OA National Cancer Institute http://www.sam.gov

RFP Number : N01CN77019-18

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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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

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. Standards for Privacy of Individually Identifiable Health Information

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

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

18. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

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. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

8. PAST PERFORMANCE FACTOR

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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 overall objective of the current acquisition, designated as the PREVENT Cancer Preclinical Drug Development Program, is to provide a structured approach to drug and vaccine development, from discovery to the clinic. To achieve these goals, this acquisition is broken out into three separate multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) pools:

PREVENT Efficacy Pool:

The Preclinical Efficacy and Intermediate Endpoint Biomarkers IDIQ contracts will encompass the continued evaluation of the efficacy of potential chemopreventive and immunopreventive regimens, and the identifcation of pharmacodynamic and/or efficacy biomarkers which will enhance the development of these regimens for clinical trials.

Resources from these contracts will be used to support development of several candidate cancer preventive agents.

PREVENT CGMP Pool:

The PREVENT Preclinical Services for Biopharmaceutical Product Development and Manufacturing encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacturing, related activities and documentation, as described in detail in the Statement of Work. The key objective of the PREVENT CGMP pool is to provide preclinical product and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing.

PREVENT Toxicology and Pharmacology Pool:

The PREVENT Preclinical Cancer Program: Toxicology and Pharmacology Testing IDIQ contracts will continue evaluation of the pharmacological and toxicological effects of potential cancer preventative agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

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ARTICLE B.3. PRICES/COSTS

a. This is a Multiple Award Indefinite Delivery 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 $3,500 (minimum) for successful performance of this contract. The maximum IDIQ ceiling amount across all PREVENT IDIQ contracts issued under the current RFP, cumulatively, shall not exceed $49,995,000 for successful performance of the contracts.

b. The costs/prices set forth in this ARTICLE will cover the contract period 11/21/2018 through 11/20/2023.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract.

d. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

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.

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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 separate PREVENT Pool IDIQ Base Statements of Work, dated 1/25/2018 for Efficacy and Pharmacology/Toxicology, and 2/07/2018 for CGMP, 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."

a. Technical Task Order Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required for any task order issued under the base contracts resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to task order award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that only electronic version(s) of reports will be required, unless otherwise specified in the base contract and/or task order, and will be required as follows:

[X] Monthly - CGMP pool [X] Quarterly - Efficacy and Toxicology pools [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [X] Final - Upon final completion of the task order (with a requirement for a Draft Final Task Order Report)

A basic description of each task order report is provided below; however, any changes or additional requirements may be specified at the individual task order level.

PREVENT Efficacy Pool

1. Quarterly Task Order Progress Reports

The Contractor shall provide Quarterly Task Order Progress Reports during performance of each task order. These reports shall include: 1) Introduction to the study; 2) Overall research strategy section; 3) A brief description of specific milestone task(s) undertaken during the reporting period; 4) http://www.hhs.gov/web/508/index.html

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Materials and methods section pertinent to the specific task(s) undertaken during the reporting period, clearly describing how studies have been performed, including a description of any statistical tests utilized to analyze data if applicable; 5) Summary of results and findings obtained over the reporting period; 6) Summary of deliverables that have been completed on the task order as applicable and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule; whether any problems have been encountered in the collection, handling, and/or processing of data; and whether resolution of the problems has been achieved or still pending; and 8) Information regarding Investigational New Drug (INDs), Drug Master File (DMF), and New Drug Applications (NDA) if applicable. The reporting period is every three (3) months, which shall commence upon award of the task order. This report is due 15 calendar days after the end of each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

The Quarterly Task Order Progress Report is not required when the Annual Task Order Progress Report is due.

2. Annual Task Order Progress Reports

The Contractor shall provide an Annual Task Order Progress Report for each task order. These reports shall include: 1) Introduction to the study; 2) Overall research strategy section; 3) A brief description of specific milestone task(s) undertaken during the one-year period; 4) Materials and methods section pertinent to the specific task(s) undertaken during the one-year period, clearly describing how studies have been performed, including a description of any statistical tests utilized to analyze data as applicable; 5) Summary of results and findings obtained over the one-year period; 6) Summary of all deliverables that have been completed on the task order and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule; whether any problems have been encountered in the collection, handling, and/or processing of data; and whether resolution of the problems has been achieved or still pending; and

8) Information regarding Investigational INDs, DMF, and NDA and other documents required by the Food and Drug Administration (FDA) as applicable. The reporting period is a 12-month period. This report shall be due 15 calendar days after each reporting period.

The Annual Task Order Progress Report is not required when the Final Task Order Report is due.

3. Draft Final Task Order Reports

These reports shall contain all collected/processed, analyzed, and summarized data, and shall be submitted 45 calendar days prior to the end of each task order. Accompanying the report, all raw data shall be submitted as specified in the base contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable.

a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary of Salient Results

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

7. Materials and Methods (including a detailed description of statistical methods used in the study)

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Appendices: Tables, Figures, Figure Legends, and High-resolution Photographs or Digital Images of Pertinent Data (e.g. Tumor Lesions, Histopathology, Immunohistochemistry Data, etc.)

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13. Supporting document and statement indicating that the study was conducted under GLP when appropriate

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the COR within 30 calendar days of receipt of the Draft Final Task Order Report.

4. Final Task Order Reports

These reports shall contain all collected/processed, analyzed, and summarized data, and shall be submitted on or before the end of the performance period of each task order. Accompanying the report, all raw data shall be submitted as specified in the base contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable. The Final Task Order Reports shall be due on or before the task order expiration date.

a. Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary of Salient Results

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

7. Materials and Methods (including a detailed description of statistical methods used in the study)

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Appendices: Tables, Figures, Figure Legends, and High-resolution Photographs or Digital Images of Pertinent Data (e.g. Tumor Lesions, Histopathology, Immunohistochemistry Data, etc.)

13. Supporting document and statement indicating that the study was conducted under GLP when appropriate

b. The Final Task Order Report shall contain a summary (not to exceed 500 words) of salient results achieved during the performance of the task order.

c. The PDF file shall contain a bookmarked Table of Contents.

PREVENT CGMP Pool

1. Monthly Task Order Progress Reports

The Contractor shall provide Monthly Task Order Progress Reports during performance of each task order. These reports shall include: 1) Introduction to the study; 2) Overall technical strategy section; 3) A brief description of specific milestone task(s) undertaken during the reporting period;

4) Materials and methods section pertinent to the specific task(s) undertaken during the reporting period, describing how studies have been carried out, including a description of analytical assays and methods utilized to analyze produced materials and data as applicable; 5) Summary of results and findings obtained over the reporting period; 6) Summary of deliverables that have been completed on the task order as applicable and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule, whether any problems have been encountered, and whether resolution of the problems has been achieved or still pending;

and 8) A Manufacturing Report, Chemistry, Manufacturing and Controls (CMC) Information, a Master File, and other regulatory documents appropriate for submission to the FDA, if applicable. The reporting period is every month, which shall commence upon award of the task order. This report is

- 9 -due 15 calendar days after the end of each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

The Monthly Task Order Progress Report is not required when the Annual Task Order Progress Report is due.

2. Annual Task Order Progress Reports

The Contractor shall provide an Annual Task Order Progress Report for each task order. These reports shall include: 1) Introduction to the study; 2) Overall technical strategy section; 3) A brief description of specific milestone task(s) undertaken during the one-year reporting period; 4) Materials and methods section pertinent to the specific task(s) undertaken during the one-year reporting period, describing how studies have been performed, including a description of analytical assays and methods utilized to analyze produced materials and data, as applicable; 5) Summary of results and findings obtained over the one-year reporting period; 6) Summary of all deliverables that have been completed on the task order and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule, whether any problems have been encountered, and whether resolution of the problems has been achieved or still pending;

and 8) A Manufacturing Report, CMC Information, a Master File, and other regulatory documents appropriate for submission to the FDA, if applicable. The reporting period is a 12-month period. This report shall be due 15 calendar days after each reporting period.

The Annual Task Order Progress Report is not required when the Final Task Order Report is due.

3. Draft Final Task Order Reports

The Draft Final Task Order Report shall describe a summation of the work performed and results obtained over the entire task order period of performance, and shall be submitted 45 calendar days prior to the end of each task order. Accompanying the report, all analytical data pertinent to the work performed shall be submitted as specified in the base contract. Reports shall be formatted and contain information necessary for regulatory FDA submission, as applicable.

a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Draft Summary Statement

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Technical Strategies

7. Materials and Methods

8. Regulatory Compliance

9. Results: Master production records, assay profiles, in-process and final product testing reports, batch reports, certificate of analysis, released drug substance, released drug product

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Supporting document and statement indicating that all studies were conducted under CGMP when appropriate

13. Appendices: Tables, figures, figure legends, high resolution, illustrative photographs or digital images of analytical and other pertinent data as appropriate

14. A Manufacturing Report, CMC Information, a Master File, and other regulatory documents appropriate for submission to the FDA

b. The PDF file shall contain a bookmarked Table of Contents.

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c. Comments or needed corrections/clarifications will be returned by the COR within 30 calendar days of receipt of the Draft Final Task Order Report.

4. Final Task Order Reports

This report shall describe a summation of the work performed and results obtained over the entire task order period of performance. Accompanying the report, all analytical data pertinent to the work performed shall be submitted as specified in the Base Contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable. The Final Task Order Reports shall be due on or before the task order expiration date.

a. Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Final Summary Statement

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Technical Strategies

7. Materials and Methods

8. Regulatory Compliance

9. Results: Master production records, assay profiles, in-process and final product testing reports, batch reports, certificate of analysis, released drug substance, released drug product

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Supporting document and statement indicating that all studies were conducted under CGMP when appropriate

13. Appendices: Tables, figures, figure legends, high resolution, illustrative photographs or digital images of analytical and other pertinent data as appropriate

14. A Manufacturing Report, CMC Information, a Master File, and other regulatory documents appropriate for submission to the FDA

b. The PDF file shall contain a bookmarked Table of Contents.

PREVENT Toxicology and Pharmacology Pool

1. Quarterly Task Order Progress Reports

The Contractor shall provide Quarterly Task Order Progress Reports during performance of each task order. These reports shall include: 1) summary of progress on the task order during the past three months, 2) summary of deliverables that have been completed on the task order, and the completion date, 3) summary of deliverables in progress on the task order and whether or not these projects are on schedule, and whether any problems were encountered in the collection, handling or processing of data, including resolution of the problems, and 4) information regarding INDs, DMF, and NDA. The reporting period is every three (3) months which shall commence upon award of the task order. This report is due 15 calendar days after each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

The Quarterly Task Order Progress Report is not required when the Annual Task Order Progress Report is due.

2. Annual Task Order Progress Reports

The Contractor shall provide an Annual Task Order Progress Report for each task order. These reports shall include: 1) summary of progress on the task order during the past year, 2) summary of deliverables that have been completed, and the completion date, 3) summary of deliverables

- 11 -in progress and whether or not these projects are on schedule, and whether any problems were encountered in the collection, handling or processing of data, including resolution of the problems, and 4) information regarding regulatory submissions such as INDs, DMF, NDA, and other documents required by the FDA. The reporting period is a 12 month period. This report is due 15 calendar days after each reporting period.

The Annual Task Order Progress Report is not required at the end of the contract performance period when the Final Task Order Report is due.

3. Study Reports

The Contractor shall prepare a Quality Assurance (QA)-audited Study Report for each nonclinical study performed under these contracts, whether Good Laboratory Practices (GLP)-compliant or not, in accordance with 21 CFR PART 58, Subpart J.

a. Draft Study Reports

A QA-audited Draft Study Report, prepared in accordance with 21 CFR PART 58, Subpart J, shall be submitted to the COR for review and comment within 60 business days after the end of in-life phase of the study. The report shall be in PDF format and shall contain a bookmarked Table of Contents.

b. Final Study Reports

A QA-audited Final Study Report, prepared in accordance with 21 CFR PART 58, Subpart J, shall be submitted to the COR within 15 business days upon receipt of the COR's comments. The Contractor shall implement and/or address all COR comments in the Final Study Report. The report shall be in PDF format and shall contain a bookmarked Table of Contents.

4. Draft Final Task Order Reports

These reports shall contain all summarized and raw data, and shall be submitted 45 calendar days prior to the end of each task order. Reports shall be formatted and contain information necessary for regulatory FDA submission.

a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

7. Materials and Methods

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Tables

13. Figures

14. Appendices

15. High Resolution, illustrative photographs or digital images of drug lesions

16. Description of Statistical Analysis used

17. Document and state that the study was conducted under GLP

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the COR within 30 calendar days of receipt of the Draft Final Task Order Report.

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5. Final Task Order Reports

This report shall contain all summarized and raw data, shall be submitted on or before the end of the performance period of each task order. Reports shall be formatted and contain information necessary for regulatory FDA submission. The Final Task Order Reports shall due on or before the Task Order expiration date.

a. Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

7. Materials and Methods

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Tables

13. Figures

14. Appendices

15. High Resolution, illustrative photographs or digital images of drug lesions

16. Description of Statistical Analysis used

17. Document and state that the study was conducted under GLP

b. The PDF file shall contain a bookmarked Table of Contents.

2. For ALL PREVENT IDIQ Pools

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 task order. This report will be required on or before the expiration date of the task order.

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. Report of USDA-Designated Biobased Products 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 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

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In accordance with FAR clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, the contractor shall report to http://www.sam.gov, with a copy to the Contracting Officer 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 on the expiration date of the contract.

3. Service Contract Report (SCR)

In accordance with FAR clause 52.204-15, Service Contract Reporting Requirements for Indefinite Delivery Contracts (Oct 2016), the Contractor shall enter and submit the following Service Contract Report data elements into System for Award Management (SAM), with a copy to the Contracting Officer annually, by October 31st for services performed under this contract during the preceding Government fiscal year (October 1 - September 30). SCR data elements:

a. Contract Number and Order Number;

b. The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract;

c. Total number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year; and

d. Data reported by first-tier subcontractors that have provided services under this contract, as applicable.

1) First-tier subcontract number (including subcontractor name and unique entity identifier)

2) The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous Government fiscal year.

4. Multiple Principal Investigators Leadership Plan

The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

**Additional deliverables may be specified at the individual task order level**

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION AND/OR PHYSICAL SECURITY

A. 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).

http://www.sam.gov

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[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).

B. Contractor 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) prior to performing any work under this acquisition.

C. Other IT Deliverables- The Contractor shall submit other IT deliverables specified in this solicitation/contract including the following: 1) encryption validation documentation, 2) encryption keys, and 3) signed Rules of Behavior (reference Section H for additional information).

D. IT Deliverables for Cloud Services (if applicable)- Offerors who propose to use cloud services in performance of the contract shall be required to provide additional IT deliverables specified in Section H, Cloud Services.

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 (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.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Cancer Institute, Office of Acquisitions, TSB 8490 Progress Drive, Suite 400 Frederick, Maryland 21701

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.

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

For the Efficacy and Toxicology pools: 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.

ARTICLE D.1. PACKAGING

CGMP Pool only: All deliverables required under this contract shall be packaged in accordance with Government specifications, industry standards, and if applicable, CGMP regulations.

ARTICLE D.2. MARKING

CGMP Pool only: All deliverables shall be marked in accordance with Government specifications, industry standards, and if applicable, CGMP regulations.

ARTICLE D.3. SHIPPING

CGMP Pool only: All deliverables shall be shipped in accordance with Government specifications, industry standards, and if applicable, CGMP regulations. As some of the biopharmaceutical products may be of a hazardous nature, the Contractor shall have the necessary licenses required by the Local, State and Federal Governments to handle, store and ship such products.

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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, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

NIH NCI Division of Cancer Prevention Chemopreventive Agent Development Research Group 9609 Medical Center Drive, Room TBD, MSC 9781 Bethesda, MD 20892

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 52.246-2, Inspection of Supplies - Fixed Price (August 1996).

FAR Clause 52.246-3, Inspection of Supplies - Cost-Reimbursement (May 2001).

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

FAR Clause 52.246-16, Responsibility for Supplies (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 11/21/2018 through 11/20/2023.

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 and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

* Items are required for all three pools unless otherwise specified.

Item Description Quantity Delivery Schedule (1a) Monthly Task Order

Progress Report (CGMP Pool ONLY)

One (1) PDF format to the COR, CO & NCI Branch C.

Due 15 calendar days after the end of each reporting period, unless an annual task order report is due during the reporting period.

(1b) Quarterly Task Order Progress Report (Efficacy & Tox/Pharm Pools ONLY)

One (1) PDF format to the COR, CO & NCI Branch C.

Due 15 calendar days after the end of each reporting period, unless an annual task order report is due during the reporting period.

(2) Annual Task Order Progress Report

One (1) PDF format to the COR, CO & NCI Branch C.

Due 12 months after the task order award and annually thereafter, unless a final task order report is due during the reporting period.

(3) Draft Final Task Order Report

One (1) PDF format to the COR, CO & NCI Branch C.

Due 45 calendar days prior to the task order completion date.

(4) Final Task Order Report One (1) PDF format to the COR, CO & NCI Branch C.

Due on or before the task order completion date.

(5) Summary of Salient Results

One (1) PDF format to the COR, CO & NCI Branch C.

Due on or before the task order completion date.

(6) Annual Utilization Report One (1) PDF format to the CO & NCI Branch C.

Due 12 months after base contract award and annually thereafter.

(7) Final Invention Statement One (1) PDF format to the CO & NCI Branch C.

Due on or before the base contract completion date.

(8) Invention Disclosure Report

One (1) PDF format to the CO, DEITR & NCI Branch C.

Due on or before the base contract completion date.

(9) Financial Conflict of Interest Documents

One (1) PDF format to the COR, CO & NCI Branch C.

Due as the conflict arises.

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Item Description Quantity Delivery Schedule

(10) Report of USDA-

Designated Biobased Products

One (1) PDF format to the COR, CO & NCI Branch C.

Due October 31st of each base contract year and on the expiration date of the contract.

(11) Contractor- Employee Non- Disclosure Agreement(s)

One (1) PDF format to the COR, CO & NCI Branch C.

Due prior to performing any work on behalf of HHS at the base level.

(12) Encryption Validation documentation (FIPS 140-2)

One (1) PDF format to the COR, CO & NCI Branch C.

Due within 15 days of the validation, at the base contract level.

(13) Encryption Keys One (1) PDF format to the COR, CO & NCI Branch C.

Due upon request of the COR and at the conclusion of the contract, at the base contract level.

(14) Rules of Behavior One (1) PDF format to the COR, CO & NCI Branch C.

Due at the beginning of the base contract and at least annually thereafter.

(15) Individual Subcontracting Report

Submit to the eSRS System. (see Article H.18)

Due on April 30th & October 30th each year during the period of performance, and upon expiration of the base contract.

(16) Summary Subcontracting Report

Submit to the eSRS System. (see Article H.18)

Due on October 30th each year during the period of performance of the base contract.

(17) Multiple Principal Investigators Leadership Plan (if applicable)

One (1) PDF format to the CO, COR & NCI Branch C.

Due as needed at the task order level.

(18) Service Contract Report One (1) PDF format to the CO, COR & NCI Branch C

Due annually on the base contract, by October 31.

(19) Assays, Standard Operating Procedures, Raw Processed Data

One (1) PDF format to the

COR

Due as needed at the task order level

For Toxicology & Pharmacology Pool

ONLY:

(20) Draft Study Report One (1) PDF format to the COR, CO & NCI Branch C.

Due within 60 business days after the end of in-life phase of the study at the task order level.

(21) Final Study Report One (1) PDF format to the COR, CO & NCI Branch C.

Due within 15 business days after reciept of COR comments from the Draft Study Report at the task order level.

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity Contracting Officer's Representative

(COR)

1-5, 9-14, 17-21 1 electronic copy

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Addressee Deliverable Item No Quantity Chemopreventive Agent Development Research Group

Division of Cancer Prevention

National Cancer Institute Contracting Officer (CO)

Office of Acquistions (OA)

National Cancer Institute

1-14, 17, 18, 20-21 1 electronic copy

Division of Extramural Inventions and Technology Resources (DEITR)

OPERA, OER, NIH,

6705 Rockledge Drive, Suite 310, MSC 7980

Bethesda, MD 20892-7980 http://www.iedison.gov

8 1 electronic copy

Electronic Subcontract Reporting System (eSRS)

Entered in www.eSRS.gov

15 & 16 1 electronic copy

NCI Branch C Invoice Inbox ncibranchcinvoices@mail.nih.gov

1-14, 17, 18, 20, 21 1 electronic copy

Service Contract Report

Entered in www.SAM.gov

18 1 electronic copy

ARTICLE F.3. 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 cost reimbursement task orders.

Alternate I (April 1984) is not applicable to fixed price task orders.

52.242-17, Government Delay of Work (April 1984) is applicable to fixed price task orders.

http://www.iedison.gov mailto:ncibranchcinvoices@mail.nih.gov https://www.acquisition.gov/?q=browsefar

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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 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 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

To be specified at time of award

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of task orders on a negotiated basis as follows:

a. General

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Only the Contracting Officer may issue task orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed task order has been awarded.