RFP_N02CM41007_27.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:

N02CM41007-27

3. Issue Date:

December 5, 2014

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Drug Development Support for the CTEP

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E620 MSC 9704 Bethesda, MD 20892-9704

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 3:00 PM local time on January 5, 2014. 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.

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 Central Contractor Registry (CCR) 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: Charlotte L. McCormack

PHONE: (240) 276-5409

e-MAIL: charlotte.mccormack@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is December 19, 2014.

Page limit is 150 pages. Please see "Additional Technical Proposal Instructions (Attachment 6)".

Please Note: Mandatory Criteria (See Section M of the RFP) http://www.sam.gov

RFP Number : N02CM41007-27

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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. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

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

10. Selection of Offerors

11. Past Performance Information

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12. Information and Physical Access Security

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Salary Rate Limitation

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Extent of Small Disadvantaged Business Participation

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. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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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.

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a wide range of services related to these responsibilities. These services include assistance with Investigational New Drug Applications (INDs), information management, assessment of adverse events, and logistical and clerical support.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is To Be Negotiated .

b. The fixed fee for the Base Period of this contract is To Be Negotiated . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. 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 To Be Negotiated .

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 (12 months) TBD TBD TBD Option Period(s):

Option 1 (12 months) TBD TBD TBD Option 2 (12 months) TBD TBD TBD Option 3 (12 months) TBD TBD TBD Option 4 (12 months) TBD TBD TBD Option 5 (12 months) TBD TBD TBD Option 6 (12 months) TBD TBD TBD

Phase-Out Option (3 months) TBD TBD TBD Total [Base Period and Option(s)] TBD TBD TBD

ARTICLE B.3. 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.4. 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

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 July 1, 2015, 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 via email as attachements to the following designated NCI Branch Distribution Mailbox: ncibrancheinvoices@mail.nih.gov.

NOTE: Hard copies of reports are no longer required and shall no longer be mailed in to NCI OA. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the contractor shall divide the deliverable into files 50 MB each. All deliverables should be limited to five file attachments or less. We understand that in some cases more than five attachments will be necessary.

The subject line of the email should read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

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."

Data transfer of PII or sensitive information to the NCI is to be encrypted.

a. Technical Progress Reports

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 in any contract resulting from this solicitation.

These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [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.]

1. Monthly IND Status Report

The Contractor shall prepare and submit a report every month on the status of all INDs in preparation. The report shall list all IND related information received by the Contractor and the date received for each section of the IND. The report shall also note outstanding information necessary to complete the IND. The monthly IND status 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.

mailto:ncibrancheinvoices@mail.nih.gov http://www.hhs.gov/web/508/index.html

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i. The report shall contain 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 -INDs submitted and withdrawn -CDRH Pre-Subs and IDEs -Number of protocol amendments and FDA submissions processed -Investigator's Brochures -FDA correspondence -Project Team Application Announcements -LOIs received reported cumulative by year -Agreements related activity- CRADAs, CTAs and CSAs -Special Tasks and the time required to complete them -New and updated CAEPRs

ii. The report shall contain 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 and the timeliness of their submission to FDA

iii. The report shall include changes in contract staffing

iv. The monthly report shall be due on or before the 21st calendar day following each monthly reporting period

3. Ad hoc Intermediate Status Reports

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 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.

i. The report shall contain in tabular form information on the status and quantity of: i. The report shall contain in tabular form information on the status and quantity of:

-INDs, protocol phase and protocol status -IND status reported cumulative by year -FDA Annual Reports -INDs submitted and withdrawn -CDRH Pre-Subs and IDEs -Number of protocol amendments and FDA submissions processed -Investigator's Brochures -FDA correspondence -Project Team Application Announcements -LOIs received reported cumulative by year -Agreements related activity- CRADAs, CTAs and CSAs -Special Tasks and the time required to complete them -New and updated CAEPRs

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ii. The report shall contain 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 and the timeliness of their submission to FDA

iii. The annual report shall be due on or before the 30th calendar day following the end of each contract year.

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. The report shall 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.

6. Phase-In and Phase-Out Plans

A 3 month Phase-In transition shall apply only wherein the current Contractor is not the recipient of this award. The Phase-In coincides with the start of the contract period and is not a separate Option. The awardee of this contract shall assist in the transition from a predecessor Contractor. The Contractor awardee shall prepare and submit a Phase-in plan to the Contracting Officer's Representative (COR) and the Contracting Officer within 15 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.

If the Contractor is not awarded the subsequent contract, the Contractor shall prepare and submit a Phase- Out plan to the COR and the Contracting Officer 90 calendar days prior to the completion date of the contract. The plan shall include but not be limited to details on the transfer of electronic documents. Upon review and approval by the Contracting Officer and the COR of the Contractor's Phase-Out Plan, the Contractor shall meet and with and provide the successor Contractor with detailed briefings regarding the policies and procedure for managing all aspects of the project.

b. Drug Development Related Reports

1. FDA Annual Reports/Development Safety Update Report

The Contractor shall prepare FDA Annual Reports for each IND sponsored by the DCTD, NCI. Reports shall be prepared in a format required by CTEP and contain all information required by federal regulations (21 CFR 312.33). FDA annual reports (reviewed by RAB and IDB) must be completed and ready for submission to FDA within 60 days subsequent of the anniversary date of the IND filing. If CTEP transitions to Development Safety Update Reports (DSUR), the Contractor shall prepare a DSUR for an investigational agent according to the ICH E2F guidance. The DSUR must be completed and ready for submission to FDA within 60 days or the Development International Birth Date. The DSUR would be in lieu of an Annual Report.

Annual Reports and DSURs shall be routed via a SharePoint site for review to designated CTEP staff and submitted as an IND amendment.

2. Ad hoc Drug Development Reports

i. Agent Development Plan Reports

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The Contractor shall prepare agent specific meeting reports using data in the CTEP enterprise system from templates prepared by CTEP. These will be requested on an ad hoc basis to coincide with company meetings

ii. Aggregate Safety Report

Safety profile reports and spreadsheets across protocols and/or investigational agents

iii. Comprehensive Reports

Comprehensive review and summary of data within an IND or across INDs

iv. Clinical Study Reports

The outline of the CSR as specified by the COR with content and format based on the International Conference on Harmonization (ICH) E3:

Guideline for Industry Structure and Content of Clinical Study Reports and to meet the needs of IDB staff.

c. Business Reports

1. Status of Funds

By August 31th of the years 2015, 2016, 2017, 2018, 2019, 2020 and 2021 the Contractor shall submit a status of funds report to the NCI Office of Acquisitions Invoice and Deliverables Tracking Modules: http:// ncifrederick.nci.nih.gov/NCIOAIT/SitePages/Home.aspx.

Based on the format included in this paragraph, provide a breakdown, by the line elements of cost as shown in the form NIH-2706 attached to this contract, of actual and projected costs expended and/or expected to be expended for the current contract year and cumulative expenditures prior to the current contract year by project code and by staff hours.

2. Ad hoc Financial Projections

Ad hoc financial projection reports may be requested for Program Review meetings, incremental funding assessment and contract year funding projections. Projections shall itemize general task areas and their associated costs for the period requested.

d. Other Reports/Deliverables

1. Section 508 Annual Report The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.hhs.gov/web/508/contracting/technology/vendors.html

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

c. Inspection and acceptance will be performed at:

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Room TBD 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 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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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 July 1, 2015 through June 30, 2016.

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 Option 1 12 Months Option 2 12 Months Option 3 12 Months Option 4 12 Months Option 5 12 Months Option 6 12 Months Phase Out 3 Months

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 dates specified below:

Item Description Delivered to Due Date A. Monthly Contract

Status Report ncibrancheinvoices@mail.nih.gov and posted to COR specified CTEP SharePoint site

21 calendar days following each reporting period

B. Annual Contract Report ncibrancheinvoices@mail.nih.gov and posted to COR specified CTEP SharePoint site

21 calendar days following each reporting period

C. Status of Funds ncibrancheinvoices@mail.nih.gov June 30 th of each contracting period

D. Final Transition out plan ncibrancheinvoices@mail.nih.gov

Due within 90 days prior to the completion date of the contract E. Draft Final Report ncibrancheinvoices@mail.nih.gov and posted to COR specified CTEP SharePoint site 15 calendar days before the completion date of the contract

F. Final Report ncibrancheinvoices@mail.nih.gov and posted to COR specified CTEP SharePoint site

On the completion date of the contract

G. Section 508 Annual Report ncibrancheinvoices@mail.nih.gov and posted to COR specified CTEP SharePoint site

21 calendar days following each reporting period

H.

Monthly IND Status Report

Contracting Officer's Representative and authorized distribution list or designated NCI Staff

Submit no later than noon the business day prior to the monthly IND status meeting mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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Item Description Delivered to Due Date I. Ad hoc Intermediate

Status Reports Contracting Officer's Representative or designated NCI Staff As needed

J.

FDA Annual reports or DSURs

Posted and routed for review via SharePoint to COR specified reviewers, then filed to the IND

Submitted to meet FDA regulations based on the IND or DSUR filing date

K.

Ad hoc Drug Development Reports

Contracting Officer's Representative

L.

Ad hoc Financial Projections Contracting Officer's Representative

M.

Quality Assurance Plan for Assessment and Accuracy of Data

(Refer to SOW 5.C)

Contracting Officer's Representative

N.

INDs and IDEs (paper and electronic)

NCI Staff as designated by the COR As needed

O.

Requested Memoranda

P.

CAEPRs, SPEERs and Condensed Risk Lists

(Refer to SOW 1.A.vi-vii)

Q.

Pre-IND/End of Phase 2 (EOPh2) briefing packets

NCI Staff as designated by the COR

R.

Draft and Final Cross Reference

Authorization Letters

S.

Draft and Final letters to investigators

T.

Written protocol reviews

U.

List of Anticipated INDs and Potential IND Withdrawals

V.

Meeting minutes

W.

Letters, Mailing Lists and Data queries related to collaborators

(Refer to SOW 1.E.iii)

X.

Pharmaceutical Collaborator Contacts List

NCI Staff as designated by the COR Quarterly or As needed

Y.

Summary Tables and Reports for IDB

(Refer to SOW

1.F.i-iv)

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Item Description Delivered to Due Date

Z.

Investigator Brochures NCI Staff as designated by the COR As needed

AA.

Drug Development Plans, Project Team

Application Announcements, Summary Tables and Written Responses

(Refer to SOW 1.J and M)

BB.

Protocol Templates

CC.

Adverse Event Reports NCI Staff as designated by the COR As needed

DD.

Drug-Disease Matrix Tables NCI Staff as designated by the COR As needed

EE.

Manuscripts/Abstracts and Slide Presentations

FF.

Phase-In Plan (when applicable)

Contracting Officer's Representative and Contracting Officer

Within 15 calendar days of the award of the contract

GG.

Phase-Out Plan (when applicable)

Contracting Officer's Representative and Contracting Officer

Within 90 days prior to contract expiration date

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

Addresses Deliverable Item No.

Contracting Officer's Representative (COR) [To be named]

A - GG

Contracting Officer (CO) [To be named] Office of Acquisitions (OA)

National Cancer Institute

A - G, FF, GG

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: http://www.acquisition.gov/far .

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.

http://www.acquisition.gov/far

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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 determined 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 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(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

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for 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.

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

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

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

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

1. The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one single attachment.

2. Save the single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number (e.g., if you are submitting Invoice 123456, save the single attachment as "Ash Stevens_Invoice 123456") [Note: Please do not use special characters such as (#, $, %,*, &, !) when saving your attachment. Only the underscore symbol (_) is permitted.]

3. Transmit the saved single attachment via e-mail to the appropriate branch's Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch E - ncibrancheinvoices@mail.nih.gov . Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contract Number_ Contract Title_ Contractor's Name_ unique Invoice number

(e.g, HHSN2612XXXXXC_Clinical Genetics Support_Ash Stevens_Invoice 12345) [Note:

The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a "proper invoice." Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the original invoice mailed to NIH's Office of Financial Management.]

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. Central Point of Distribution. For the purposes of this contract, the Central Point of Distribution is NCI OA Branch E - ncibrancheinvoices@mail.nih.gov.

c. 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 the Contracting Officer.

d. 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

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(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.

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

f. 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.

g. The Contract Title is:

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

h. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

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.

(End of Clause)

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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. 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 Government Property," which can be found at:

http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix Q_HHS Contracting Guide.pdf.

ARTICLE G.7. 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 http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.3. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes;

or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.6. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

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(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http:// oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm.

ARTICLE H.7. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 30 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST PLUS FIXED FEE Article in SECTION B of this contract.

ARTICLE H.8. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated (to be determined) is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes at the following e-mail address:

To be determined Contracting Officer http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm http://www.esrs.gov/

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ARTICLE H.9. INFORMATION AND PHYSICAL ACCESS SECURITY

A. HHS-Controlled Facilities and Information Systems Security

a. To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

b. To gain routine physical access to an HHS-controlled information system, and/or access to sensitive data or information, the Contractor and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; Office of Management and Budget Memorandum (M-05-24); and Federal Information Processing Standards Publication (FIPS PUB) Number 201; and with the personal identity verification and investigations procedures contained in the following documents:

1. HHS-OCIO Information Systems Security and Privacy Policy ( http://www.hhs.gov/ocio/policy/ #Security)

2. HHS HSPD-12 Policy Document, v. 2.0 ( http://www.whitehouse.gov/sites/default/files/omb/assets/ omb/memoranda/fy2005/m05-24.pdf)

3. Information regarding background checks/badges ( http://idbadge.nih.gov/background/index.asp)

c. Position Sensitivity Levels:

This contract will entail the following position sensitivity levels:

[ ] 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).

d. The personnel investigation procedures for Contractor personnel require that the Contractor prepare and submit background check/investigation forms based on the type of investigation required. The minimum Government investigation for a non-sensitive position is a National Agency Check and Inquiries (NACI) with fingerprinting. More restricted positions - i.e., those above non-sensitive, require more extensive documentation and investigation.

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access and/or maintain a Federal Information System(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days after the effective date of the contract. The Contracting Officer shall notify the Contractor of the appropriate level of suitability investigations to be performed. 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.

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.

http://www.hhs.gov/ocio/policy/#Security http://www.hhs.gov/ocio/policy/#Security http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf http://idbadge.nih.gov/background/index.asp https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

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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.

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.

e. Investigations are expensive and may delay performance, regardless of the outcome of the investigation.

Delays associated with rejections and consequent re-investigations may not…