N02CM71017-38_Solicitation_with_Attachments.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

N02CM71017-38

3. Issue Date:

July 17, 2017

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Storage and Distribution of Clinical Agents

6. ISSUED BY:

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

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 PM local time on August 15, 2017. Offers will be valid for 240 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." The OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: Pooja Rathore

PHONE: (240) 276-7325

e-MAIL: pooja.rathore@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Last day for questions:

July 27, 2017

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

Secondary Point of Contact:

Margo Katzper Contracting Officer,OA, NCI margo.katzper@nih.gov http://www.sam.gov

RFP Number : N02CM71017-38

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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. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. 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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Certification of Filing and Payment of Taxes

11. Past Performance Information

12. Information and Physical Access Security

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

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Mandatory Qualification Criteria

2. Technical Discussions

3. Other Considerations

4. Technical Evaluation

5. Obtaining and Disseminating Biomedical Research Resources

6. Instructions to Offerors-Sustainable Acquisition, HHSAR Provision 352.223-71 (December 2015). . . 67

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. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

13. Option to Extend Services

14. SCA Wage Rate Determination

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. EVALUATION OF SUSTAINABLE ACQUISITION PLAN

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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 Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for providing pharmaceutical support for clinical trials sponsored and/or funded by CTEP, DCTD, NCI. The PMB manages the Contractor who maintains and operates the NCI Clinical Repository for the CTEP, DCTD, NCI. This contract is responsible for the receipt, storage, distribution and final disposition of hundreds of clinical investigational agents. The Contractor must maintain special expertise in the management, labeling and distribution of clinical supplies for double-blind placebo-controlled trials. The Contractor receives and inspects agents according to applicable regulations as they are received from manufacturers and suppliers throughout the world. Agents are inventoried and stored in a secured, monitored, fire-protected warehouse under specified environmental and controlled temperature conditions. Computerized record keeping accompanies each step of the process through receipt, storage, distribution, and final disposition of each unit of agent using the PMB computerized inventory system.

ARTICLE B.2. PRICES/COSTS

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

ARTICLE B.3. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is To Be Determined (TBD)* .

b. The fixed fee for the Base Period of this contract is TBD . 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 TBD .

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:

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (Feb 1, 2018 - Jan 31, 2019) TBD TBD TBD

Option C-1 (increased capacity) TBD TBD TBD

Option Year 1 (Feb 1, 2019 - Jan 31, 2020) TBD TBD TBD

Option C-2 (increased capacity) TBD TBD TBD

Option Year 2 (Feb 1, 2020 - Jan 31, 2021) TBD TBD TBD

Option C-3 (increased capacity) TBD TBD TBD

Option Year 3 (Feb 1, 2021 - Jan 31, 2022) TBD TBD TBD

Option C-4 (increased capacity) TBD TBD TBD

Option Year 4 (Feb 1, 2022- Jan 31, 2023) TBD TBD TBD

Option C-5 (increased capacity) TBD TBD TBD

Option A: Phase-In Facility Change (2 Months) TBD TBD TBD

Option B: Phase-Out Transition (3 Months) TBD TBD TBD

Total: Base Period and Option(s) TBD TBD TBD

ARTICLE B.4. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

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

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

CLIN, Task, Number, or Description

Start Date of Period or Increment of Performance

End Date of Period or

Increment of Performance

Estimated Cost ($)

Fee ($)

Estimated Cost Plus Fee ($)

[Total] [Total] [Total]

*To be inserted after negotiation

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

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

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

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

The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer.

ARTICLE B.5. 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.6. 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.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated July 17, 2017, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibrancheinvoices@mail.nih.gov and ncictepanalyst@mail.nih.gov.

Note: Hard copies of reports are no longer required and shall no longer be mailed to NCI, OA. Each email submission shall contain only one deliverable. If the attached files for the deliverables exceed 50 MB, the contractor shall divide the deliverables into files of 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.

http://www.hhs.gov/web/508/index.html

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a. Technical 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 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.

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. Receipt of Clinical Agents Notification

Within 3 hours of arrival of an agent shipment, the Contractor will notify the COR and the Pharmaceutical Management Branch (PMB) responsible pharmacist for the agent, a summary of the shipment receipt details via e-mail. Information to be conveyed will include:

· Agent Name

· Strength

· Formulation

· Number of different lot numbers of agent included in the shipment

· Unconfirmed number of unit packages received based on shipping/packing list(s)

· Any immediately apparent problems or discrepancies

By the end of the business day of the shipment receipt, the Contractor will enter the receipt details into the PMB inventory management system: Drug Authorization and Review Tracking System (DARTS). Occasional expedited entry into DARTS may be required to support urgent needs for distribution of the supply received. In addition, a complete summary of the shipment receipt will be provided to the COR and the PMB responsible pharmacist for the agent via e-mail. Information to be conveyed will include:

· Agent Name

· Strength

· Formulation

· Confirmed total number of unit packages received and number of unit packages of different lot numbers, if applicable

· Identified problems or discrepancies

· Condition of shipment

· A copy of the agent label (container label and package label)

· A copy of all documentation accompanying shipment (e.g., Certificate of Analysis, MSDS, Confirmation of receipt, temperature data logs, packing slips, customs documents)

The Contractor shall convert all shipment receipt documentation into electronic pdf format by the end of the business day of the shipment receipt for record storage and retention by the Government. Contractor shall provide quality control review for each electronic file created to ensure completeness, accuracy and readability. A standardized file naming convention and electronic file storage process is in place which the Contractor shall follow.

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2. Return Drug List Forms

The repository executed and processed Return Drug List Forms will be provided to the COR for review on an ongoing basis. The executed and processed Return Drug List Forms shall be scanned, quality checked for clarity (minimum 400 dpi resolution), readability and completeness, named per a standardized and established file name convention and saved to a PMB shared network drive as directed by the COR. Forms shall be available for review by the COR within 7 calendar days following receipt and execution and processing of the Return Drug List Form(s) and agents returned by the clinical trial site.

3. Pricing Structure Table The Contractor shall establish a pricing structure table consistent with the Government pricing structure for receipt, storage, shipping and final disposition of agents. The pricing structure table will be used by the Government for the purposes of creating cost estimates for individual studies.

The pricing structure table shall be updated annually in January of each calendar year. The initial pricing structure table shall be submitted within 3-months of contract award.

4. Physical Inventory Report Coinciding with the option period durations of the contract, the Contractor shall perform a complete physical inventory of all agents stored in the repository, at a single point in time, at the mid-point and end of the option period (i.e., at the end of every 6-month period if option period duration is 12-months). For option period durations of less than 12-months, the frequency of the complete physical inventory shall be agreed upon with the COR, but shall at a minimum, occur at the end of the option period. Reports shall be submitted electronically within 15 calendar days following the end of the reporting period.

5. Ad Hoc Inventory Report The Contractor shall perform and report limited, special inventory checks as requested by the COR to resolve inventory discrepancies on an as needed basis.

6. Monthly Progress Report This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. This report shall include a summary of all aspects of agent receipt, distribution and return agent processes. The report shall include a description of all aspects of the repository operation that were not performed satisfactorily (e.g., error/incident reports). The report shall include analysis of problems and corrective action plans implemented.

The report shall include printouts from temperature and humidity monitors from all storage areas and storage units. A physical inventory of each agent shall also be conducted on a rolling basis and reported monthly to the COR in the Monthly Progress Report. All individual agent inventories performed shall be submitted with the monthly report for the month in which the agent inventory is conducted. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. Reports shall be submitted electronically within 10 calendar days following the end of the reporting period.

7. End of Option Period Progress Report This report shall include a summation of previously submitted monthly reports. The initial report will be submitted for the first full 12-months of the contract performance including any fractional part of the initial month. This report shall include a report of the complete physical inventory of all agents held in the repository and summation of any inventory discrepancies noted, if present.

Thereafter, the reporting period shall consist of the entire full calendar months defined by the

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8. Final Report This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to comprehensively describe the results achieved. The Final Report shall include a final physical inventory of all agents and summation of any inventory discrepancies noted, if present. The Final Report shall be submitted in accordance with the deliverables of this contract. A draft Final Report shall be submitted within 15 calendar days prior to the end of the contract for review and approval by the COR and Contracting Officer. Once approved, the Final Report shall be submitted on the completion date of the contract. An End of Option Period Progress Report will not be required for the period when the Final Report is due.

9. Phase-in Option Plan/Execution The Contractor shall prepare and submit a Phase-in plan to the COR and the Contracting Officer for review prior to the contract award. The final plan shall be approved by the COR and CO within 10 calendar days of the award of the contract. The plan shall include, but not be limited to, details on the transfer of filed material and documents and the transfer of agent inventory and Government-furnished equipment. Upon review and approval by the Contracting Officer (CO) 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 Contractor shall move all agent inventories, files, and Government provided equipment from the predecessor Contractor's facility to its facility within 60 calendar days of contract award. The Contractor shall transfer agent inventory under proper and documented controlled temperatures. The Contractor's facilities and storage units shall be qualified and validated by the Contractor prior to receiving the transferred agent inventory.

This transfer of agent inventory, files and equipment shall be performed in coordination with the predecessor Contractor, the Contracting Officer, and the COR. The Contractor shall meet, and work with, the predecessor Contractor, COR and CO to ensure that work operations are fully understood and continuity of operations are maintained through the transition.

10. Phase-out Option Plan/Execution 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 filed material and documents and the transfer of agent inventory and Government-furnished equipment. Upon review and approval by the Contracting Officer and COR of the Contractor's Phase-Out Plan, the Contractor shall meet with and provide the successor Contractor, COR and CO with detailed briefings regarding the policies and procedure for managing all aspects of the project. The Contractor shall make the facility available to the successor Contractor at least 60 calendar days prior to the beginning of the new contract to affect the transfer of all contract related items to be transferred to the successor Contractor. This includes any inspections to determine the personnel and equipment required for the transfer as well as the physical transfer. The Contractor shall meet, and work with, the successor Contractor to ensure that work operations are fully understood and continuity of operations are maintained through the transition.

11. Policies, Standard Operating Procedures and Work Instructions The Contractor shall prepare written policies and SOPs and work instructions that govern operations of the facility and activities described in this Statement of Work. The policies, SOPs and work instructions shall cover areas including, but not limited to, operational, validation, quality and safety aspects of the work. All policies, procedures and work instructions shall be submitted in electronic pdf format and initially submitted within 60 days of contract award. Any new or updates to existing policies, procedures or work instructions shall be submitted within 30 days of implementation.

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12. Shipping Container Validation or Qualification Reports Qualification or validation reports for each shipping container used on the Contract shall be provided to the COR. Qualification or validation reports shall be submitted within 14 days of contract award.

b. Other Reports/Deliverables

1. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

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, or host 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 of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

The contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

The contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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d. FIPS 199 Assessment

The Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

h. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this

- 12 -report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

2. 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."

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.

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 9609 Medical Center Drive Rockville, MD-20850

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

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

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 02/01/2018 through 1/31/2019.

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 Year 1 February 1, 2019 - January 31, 2020 http://www.hhs.gov/web/508/contracting/technology/vendors.html

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Option Option Period Option Year 2 February 1, 2020 - January 31, 2021 Option Year 3 February 1, 2021 - January 31, 2022 Option Year 4 February 1, 2022 - January 31, 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:

Item Description Quantity Delivery Schedule

(1) Receipt of Clinical Agents

Notification 1 By the end of the business day upon which the agent shipment was received.

(2) Returned Drug List Forms 1 Within 7 calendar days following receipt and execution and processing of the Return Drug List Forms and agents returned by the clinical trial site.

(3) Pricing Structure Table 1 By the end of January every calendar year.

(4) Physical Inventory Report 1 Within 15 calendar days following each reporting period.

(5) Ad Hoc Inventory Report 1 At the request of the COR to resolve inventory discrepancies.

(6) Monthly Progress Report 1 10 calendar days following each reporting period.

(7) End of Option Period

Progress Report 1 15 calendar days following each reporting period.

(8) Draft/Final Report 1 Draft due 15 calendar days before the completion date of the contract. Final due on the completion date of the contract.

(9) Phase-In Option Plan/ Execution

1 Prior to contract award at time of proposal submission and approved within 10 days of contract award. Phase-In Execution within 60 days following award of the contract.

(10) Phase-out Option Plan/ Execution

1 90 calendar days prior to completion date of contract.

Phase-out execution prior to the completion date of the contract.

(11) Policies, Standard Operating Procedures and Work Instructions

1 Within 60 days of contract award and within 30 days of implementation of new or updates to existing policies, procedures or work instructions.

(12) Shipping Container Validation or Qualification Reports

1 Within 14 days of contract award

(13) Section 508 Annual Report 1 Draft 30 days prior to the end of each contract year. Final report due prior to the expiration of each Base or Option (Phase)

(14) Roster of Employees Requiring Suitability Investigations

1 The roster is due within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change

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Item Description Quantity Delivery Schedule (15a) IT Security Plan

(IT-SP)

1 The IT Security Plan shall be due within 30 days after contract award in accordance with NIST SP 800-53A, Guide for Information Technology Systems.

(15b)

IT Security Plan (IT-SP) Annual

1 The IT Security Plan shall be shall be reviewed and updated by the contractor in accordance with NIST SP 800-53A, Guide for Information Technology Systems, on an annual basis.

(16a) IT Risk Assessment

(IT-RA)

1 The IT Risk Assessment shall be due within 30 days after contract award.

(16b) IT Risk Assessment (IT-RA) Annual

1 The IT-RA shall be updated on an annual basis.

(17a) IT Security Certification and Accreditation

(IT-SC&A)

1 The IT Security Certification and Accreditation (IT-SC&A) shall be due within 3 months after contract award.

(17b) IT Security Certification and Accreditation

(IT-SC&A)

1 The Contractor shall perform an annual security control assessment and provide verification that the IT-SC&A remains valid.

(18) FIPS 199 Assessment 1 The FIPS 199 Assessment shall be due within 30 days after contract award.

(19) Reporting of New and Departing Employees

1 The notification shall occur within 5 working days of staffing changes.

(20) Contractor/Employee Non- Disclosure Agreements

1 Non-Disclosure Agreements for all Contractor employees who may have access to non-public information shall be submitted prior to performing any work under the contract.

b. The above items shall be e-mailed and delivered to:

Addressee Deliverable Item No. Electronically COR Pharmaceutical Management Branch

CTEP, DCTD, NCI

9609 Medical Center Drive

Room 5W228

Rockville, MD 20850

Items (1) - (20) TBD

Contracting Officer

Office of Acquisitions

National Cancer Institute

9609 Medical Center Drive

Room___

Rockville, MD 20850

Items (3) - (20) TBD

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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 this contract.

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 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 TBD - To Be Determined

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 "ABC Company_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_ABC Company_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. 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.

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the System for Award Managem .

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

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Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

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

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

f. The Contract Title is:

Storage and Distribution of Clinical Agents

g. 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) 496-6088.

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)

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

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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://oamp.od.nih.gov/sites/default/ files/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 on an annual basis coinciding with the anniversary.

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://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.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. 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.3. LIMITATION ON USE OF FUNDS FOR PROMOTION OF…