BARDA RFP No 75A50121R00012 with Attachments.pdf

SOLICITATION

SECTION A – SOLICITATION/CONTRACT FORM

Requisition or Purchase Authority: 42 U.S.C. 247d Request for Proposal (RFP) number:

75A50121R00012

Issue date: June 2, 2021

Set aside:

[X] No [ ] Yes, see SECTION L

Title: Non-Clinical Development Chemical Network

Issued by:

Biomedical Advanced Research and Development Authority 200 C Street SW Washington, DC 20024

Submit offers to:

See SECTION L

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received as specified in SECTION L until 11:00 am local time on July 19, 2021. Offers will be valid for 270 days unless a different period is specified by the offeror. Please email all questions about this solicitation to the CO, Jeffrey Brown at Jeffrey.Brown@hhs.gov or the CS, de Ionne Jones at Deionne.Jones@hhs.gov by June 23, 2021 no later than 5:00PM EST. No response will be provided to questions submitted after this date.

This solicitation requires delivery of proposals as stated in SECTION L.

If your proposal is not received by the Contracting Officer by the time specified, then it will be considered late and be ineligible for award.

Offeror must be registered in the System for Award Management (SAM) when submitting an offer or quotation and shall continue to be registered until time of award. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov.

For information contact:

de Ionne Jones, Contract Specialist

(202) 969-3872 deionne.jones@hhs.gov Jeffrey Brown

Contracting Officer

CNCR, CMA, BARDA

http://www.sam.gov/ mailto:deionne.jones@hhs.gov

Solicitation Number: 75A50121R00012

PART I – THE SCHEDULE

SECTION B – SERVICES AND COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES

The purpose of this Multiple Award Indefinite Quantity/Indefinite Delivery contract is to maintain a network of contractors to provide nonclinical laboratories to support chemical medical countermeasure development. This contract supports nonclinical model development and evaluating the efficacy of potential chemical MCMs to (1) pulmonary agents, cyanide, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation ingestion and topical routes; and/or (2) nerve agents and vesicants, including sulfur mustard by inhalation, ingestion, and topical routes.

ARTICLE B.2. COSTS

a. This is a Multiple Award Indefinite Quantity/Indefinite Delivery contract as contemplated by FAR

16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $75,000 (minimum) nor more than a total of $45,000,000 (maximum for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract ordering period described in SECTION F of this contract.

c. The Government will compete and award task orders based on the objectives described in SECTION C of this contract.

d. Task orders procedures are described in SECTION G of this contract.

ARTICLE B.3. ADVANCE UNDERSTANDINGS

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

a. Non-Personal Services and Inherently Government Functions

1. Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

2. Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

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

b. Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of this contract and as follows:

Contract No. _____________

c. Priorities and Allocations Authority

The Government and Contractor agree that the Government reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

d. Notice of Earned Value Management System for Task Orders

The Government and Contractor agree that all Requests for Task Orders (RTORs) and task orders with a total value in excess of $20,000,000 will include Earned Value Management System requirements.

ARTCILE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

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

a. Conferences and Meetings.

b. Food for Meals, Light Refreshments, and Beverages.

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

d. Special rearrangement or alteration of facilities.

e. Purchase or lease of any item of general-purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.).

f. Travel to attend general scientific meetings.

g. Foreign travel.

h. Consultant costs.

i. Subcontracts.

j. Patient care costs.

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

l. Printing Costs (as defined in the Government Printing and Binding Regulations).

m. Travel Costs.

n. Overtime.

SECTION C – DESCRIPTION/SPECIFICATION/WORKSTATEMENT

ARTICLE C.1. STATEMENT OF OBJECTIVES

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Objectives set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.

ARTICLE C.2. REPORTING AND MEETING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Kick-Off Meeting

The Contractor shall complete a Kickoff meeting after contract award and/or within a month of task/delivery order award to be held at a location determined by the COR. The purpose of the Task/Delivery Order initiation meeting will be to orient the contractor to HHS/BARDA task/delivery order procedures, review contract requirements, and to plan implementation of initial task/delivery order activities.

b. Status Update Meetings

Plan and conduct meetings of the contractor’s Program Director, Program Team, Contracting Officer’s Representative and Contracting Officer. This will include other BARDA personnel deemed appropriate by the Contracting Officer’s Representative, at a minimum of monthly intervals, either in person or via teleconference, to review protocols, the status of approved work assignments, discuss any matters relevant to the scientific and financial administration of the contract and future activities. The contractor shall prepare and distribute the agenda as well as meeting/teleconference materials to all participants, provide a summary of all meetings, and teleconferences.

c. Once Every Two Weeks Teleconference

A conference call between the Contracting Officer’s Representative and designees and the Contractor’s Project Leader/delegate and designees shall occur bi-weekly or as otherwise determined by the Contracting Officer. The contractor shall participate in biweekly teleconferences with BARDA to discuss the performance of the contract. The contractor shall record, maintain and provide draft meeting minutes to the Contracting Officer’s Representative for approval within three days after teleconference. The Contracting Officer’s Representative will approve the draft version. The contractor shall distribute the final approved version duly marked as final within 3 business days after receipt of BARDA approval.

d. Annual Meetings

The Contractor shall arrange and may conduct annual site visits for BARDA staff to review and discuss the following items: project progress; problems, obstacles, and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the Principal Investigator, the contractor’s business representative, and all key personnel. The contractor shall be responsible for the following activities:

1. Planning and submitting the agenda to the Contracting Officer’s Representative for approval.

2. Developing written and oral presentation materials of all task/delivery orders.

3. Presenting summaries of all active task/delivery orders.

4. Discussing timelines related to active and future task/delivery orders.

5. Discuss methodologies and approaches.

e. Periodic Site Visits

Contractor shall accommodate periodic or ad hoc site visits by BARDA. If BARDA, the Contractor, or other parties identify any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to BARDA.

If issues are identified during the audit, Contractor shall submit a report to BARDA detailing the finding and corrective action(s) within ten business days of the audit. The COR and CO will review the report and provide a response to the Contractor with ten business days. Once corrective action is completed, the Contractor will provide a final report to BARDA.

f. Security and Quality Systems Audits/QA Audits.

BARDA reserves the right to participate in QA audits performed by the contractor. Upon completion of the audit/site visit, the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA.

The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action.

Contractor shall notify CO and COR a minimum of ten business days in advance of upcoming, audits/site visits of subcontractors.

Contractor shall notify the COR and CO within five business days of report completion.

COR and CO will review the report and provide a response to the Contractor within ten business days.

g. Task Order Monthly/Quarterly/Annual/Final Technical Progress Report

While performing under a task order, the Contractor shall submit Technical Progress Reports on a monthly, quarterly, and annual basis. These reports must include or address each of the below items and be cross-referenced to the WBS in the Gantt chart.

1. An Executive Summary in MS PowerPoint format, highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory. The Executive Summary should be limited to a few slides and highlight only critical issues for that reporting period and resolution approach.

2. Progress in meeting contract milestones - broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned progress and actual progress during the period covered, explaining occurrences of any differences between the two, and the corrective steps and actions are planned, if behind schedule.

3. The reports shall also include a three-month rolling forecast of key planned activities, referencing the WBS.

4. A tracking log of progress on regulatory submissions with the FDA submission number, description of submission, date of submission, status of submission, and next steps.

5. Estimated and Actual Expenses

This report shall also contain a narrative statement as to whether there is any discrepancy at this time between the % of work completed and the cumulative costs incurred to date. This section of the report shall also contain estimates for the subcontractors' expenses from the previous month if the subcontractor did not submit a bill in the previous month. These expenses shall be listed for each subcontractor.

If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

Milestones will be identified for each Task/Delivery Order and progress toward each Milestone will be reported as part of the Technical Progress Report. Separate Milestone reporting is not required.

h. Standard Operating Procedures

At the request of the COR, the contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically.

i. Technical Documents

At the request of the COR, the Contractor shall provide complete technical documents for COR review and approval. All documents shall be duly marked as either 'Draft' or 'Final'. These technical documents shall include, but shall not be limited to, the following:

1. Non-clinical study overview with flowchart (demonstration of relationship between studies should include clinical study).

2. Draft SOWs to be sent to subcontractors for concept approval, including number of animals.

3. Draft protocols and critical reagents.

4. Draft and Final Reports.

j. FDA Reporting and Meeting Requirements

1. FDA Correspondence and Meeting Summaries

The Contractor shall forward initial CBER/CDER-issued draft minutes and final minutes of any meeting with the FDA to COR. All documents shall be duly marked as either 'Draft' or 'Final'.

2. FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to COR and make arrangements for appropriate BARDA staff to attend the FDA meetings.

BARDA staff shall include up to a maximum of four people (Contracting Officer’s Representative, Contracting Officer, and up to 2 subject matter experts).

3. FDA Submissions

The Contractor shall provide COR the opportunity to review and comment; upon all draft regulatory documents before submission to the FDA. The Contractor shall provide COR with an electronic copy of the final FDA submission. All documents shall be duly marked as either 'Draft' or 'Final'.

4. FDA Audits

The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all FDA's arrival to conduct site visits/audits by any regulatory agency. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract. The contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483, and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

k. Contractor Audit/Site Visits

The Contractor shall inform the Contracting Officer’s Representative and Contracting Officer in advance of upcoming audits/site visits of subcontractors as part of the bi-weekly communications, including goals and agenda. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, details and concerns for addressing areas of non-conformance to FDA regulations for GLP guidelines, as identified in the audit report, must be provided to COR. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

l. Risk Mitigation

With every response to a Request for Task Order Response, the Contractor shall provide a Risk Mitigation Plan Matrix and shall describe a comprehensive plan outlining program and risk management.

m. Final Closeout Report

The Contractor shall submit a comprehensive Final Report that details, documents, and summarizes the results of the entire (base and all option periods) contract work. The report shall explain comprehensively the results achieved. It shall also contain a summary of all Task Orders issued under the contract and a determination that everything under the contract has been completed and accepted. A draft Final Report shall be submitted to the CO and COR for review and comment at least 45 days prior to contract expiration date.

n. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in electronic format.

Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

o. Information Security Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION SECURITY Article in SECTION H of this contract.

1. 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, can 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 days of the effective date of the contract.

2. Reporting of New and Departing Employees

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

i. 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.

ii. 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.

3. 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. The "Commitment to Protect Non-Public Information – Contractor Agreement" shall be submitted to the Contracting Officer within 14 days of the effective date of the contract.

4. Contract Deliverables Due at Expiration

The Contractor shall provide the following deliverables on or before contract expiration:

i. Sanitization of Government Files and Information – As part of contract closeout and at expiration of the contract, the Contractor shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and COR to certify that, at the Government's discretion, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

ii. Contractor Responsibilities Upon Physical Completion of the Contract – The Contractor shall return all Government information and IT resources (i.e., Government information in non-Government owned systems, media, and backup systems) acquired during the term of this contract to the CO and COR.

Additionally, the Contractor shall provide a certification that all Government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS policies.

p. Government Information Processed on GOCO or COCO Systems

The Contractor shall submit the following reports as required by the GOVERNMENT INFORMATION PROCESSED ON GOCO OR COCO Article in SECTION H of this contract.

1. SA&A Package Deliverables:

i. System Security Plan.

ii. Security Assessment Plan/Report.

iii. Independent Assessment.

iv. Plan of Actions and Milestones.

v. Contingency Plan and Contingency Plan Test.

vi. E-Authentication Questionnaire.

2. Information Security Continuous Monitoring Deliverables:

i. Annual Assessment/Pen Test.

ii. Asset Management.

iii. Configuration Management.

iv. Vulnerability Management.

q. Service Contract Reporting Requirements for Indefinite-Delivery Contracts

The Contractor shall report on services performed as required by FAR Clause 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (January 2014) incorporated by reference in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract and the DELIVERIES Article in SECTION F of this contract.

r. Invention Reporting Requirements

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract.

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

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

s. Task Order Reports and Deliverables

In addition to those reports required by other terms of this contract, the Contractor shall submit reports and deliverables as identified in task orders. These reports shall be subject to the INSPECTION AND ACCEPTANCE Article in SECTION E of this contract.

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

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

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

3. Inspection and acceptance will be performed at:

Biomedical Research and Development Authority (BARDA) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services (DHHS) 200 C Street SW Washington, DC 20515

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

4. 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 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

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

SECTION F – DELIVERIES OR PERFORAMNCE

ARTCILE F.1. ORDERING PERIOD

The ordering period for this contract shall include a one-year base and four one-year option periods.

ARTCILE F.2. DELIVERIES

The items specified below as descried 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 the date(s) specified below:

Item

Description

Delivery Method & Addressee

Delivery Schedule

(1) Task Order Monthly Progress Report Electronically to CO

& COR

15th day of every month during performance of a task order

(2) Task Order Quarterly Progress Report Electronically to CO

& COR

Quarterly as defined in the task order during

(3) Task Order Annual Progress Report Electronically to CO

& COR

Annually as defined in the task order

(4) Task Order Final Technical Progress Report

Electronically to CO

& COR

On or before task order expiration

(5) Standard Operating Procedures Electronically to CO

& COR

7 days following request from the COR

(6) Technical Documents Electronically to CO

& COR

7 days following request from the COR

(7) FDA Reporting and Meeting Requirements

Electronically to CO

& COR

As specified in ARTICLE C.2.

(8) Risk Mitigation Plan Electronically to CO

& COR

With responses to Request for Task Order Responses

(9) Final Closeout Report Electronically to CO

& COR

On or before contract expiration

(10) Reporting of Financial Conflict of Interest Electronically to CO

& COR

In accordance with 45 CFR Part 94

(11) Roster of Employees Requiring Suitability Investigations

Electronically to CO

& COR

Within 14 days after the effective date of the contract

(12) Reporting of New and Departing Employees

Electronically to CO

& COR

Within 7 days following staffing changes for positions that require suitability investigations

(13) Contractor – Employee Non-Disclosure Agreement(s)

Electronically to CO

& COR

Within 14 days after the effective date of the contract

(14) Sanitization of Government Files and Information

Electronically to CO

& COR

On or before contract expiration

(15) Contractor Responsibilities Upon Physical Completion of the Contract

Electronically to CO

& COR

On or before contract expiration

(16) System Security Plan Electronically to CO

& COR

Within 30 days after contract award

(17) Security Assessment Plan/Report

(SAP/SAR)

Electronically to CO

& COR

Within 30 days after contract award

(18) Independent Assessment Electronically to CO

& COR

Within 90 days after contract award

(19) POA&M Electronically to CO

& COR

Within 30 days after contract award

(20) Contingency Plan and Contingency Plan Test

Electronically to CO

& COR

Within 60 days after contract award

(21) Annual Assessment/Pen Test Electronically to CO

& COR

Annually on contract anniversary

(22) Assess Management Inventory Report Electronically to CO

& COR

Within 60 days after contract award

(23) Configuration Management Compliance Electronically to CO

& COR

Within 60 days after contract award

(24) Vulnerability Management Capability Notice

Electronically to CO

& COR

Within 30 days after contract award

(25) Service Contract Reporting Requirements for Indefinite-Delivery Contracts

Electronically to sam.gov

Annually on October 31

(26) Invention Reporting Requirement – Annual Utilization Report

Electronically to CO Annually on contract anniversary date

(27) Invention Reporting Requirement – Final invention Statement

Electronically to CO On or before contract expiration

(28) Incident Reporting Electronically to CO

& COR

See ARTICLE H.31

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

The 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

SECTION G – CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER

a. The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

b. The CO is the only person with authority to act as agent of the Government under this contract.

Only the CO 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) obligate or de-obligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

c. No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

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

To be determined prior to contract 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.3. 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

ARTICLE G.4. CONTRACTOR’S POINT OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

ARTICLE G.5. TASK ORDER PROCEDURE

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

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Request for Task Orders (RTOR) will be prepared and issued for each task order requirement.

Generally, the RTOR will include but is not limited to the following:

1. Statement of Work or Statement of Objectives.

2. Reporting Requirements and Deliverables.

3. Proposal Due Date and Location to Deliver Proposals.

4. Period of Performance of Task Order.

5. Anticipated type of Task Order.

6. Technical Proposal Instructions.

7. Business proposal Instructions.

8. Evaluation Factors for Award.

All contract clauses contained this contract shall be incorporated in the RTOR and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the task order language takes precedence over the information in the contract.

Contractors are not required to propose on all RTORs. Contracts are required to respond with intent to propose for each RTOR. If the Contractor is not capable of performing the services described in the RTOR, the Contractor must notify the Contracting Officer in writing within the notification time established by the RTOR for notification of intent to propose or, if a notification date is not provided, prior to the close of the RTOR.

Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the RTOR. An election not to propose on a given RTOR will not negatively affect or prohibit a Contractor from competing on future RTORs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

i. Understanding of the requirements;

ii. Experience and capability on similar tasks;

iii. Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies.

iv. Procedures for assuring quality of work, products, and deliverables;

v. Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

vi. Staffing plan with skill levels and level of effort for each individual proposed.

Generally, resumes will be required for proposed personnel (if not previously submitted);

vii. References to evaluate past performance; and

viii. Cost/Price to perform the task order.

3. If necessary, the Contracting Officer will arrange a teleconference between the Contractor and the Contracting Officer to discuss the proposed Task Order prior to submitting Task Order proposals (technical and business).

d. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the RTOR.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the RTOR will be used for evaluation of each proposal. In addition, the RTOR will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each RTOR will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order.

e. Fair Opportunity

1. In accordance with FAR 16.3505(b)(1)(i), each awardee will be given a f air opportunity to be considered for each order issued over $3,500 unless the following exception(s) apply:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

i. For orders exceeding $3,500 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

ii. For orders exceeding the simplified acquisition threshold up to $5.5 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $5.5 Million, in accordance with FAR 16.505(b)(1)(iv).

ARTICLE G.6. INVOICE SUBMISSION

Invoice submission instructions for Cost-Reimbursement Type and Firm-Fixed Price contracts are attached and made part of this contract. The Contractor shall follow the attached invoice submission instructions.

ARTICLE G.7. 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.8. 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.

The Contractor will submit the final indirect cost rates proposal to DFAS with a copy to the Contracting Officer.

ARTICLE G.9. GOVERNMENT PROPERTY

a. In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "HHS Contracting Guide for Contract of Government Property," which is incorporated into this contract by reference. This document can be accessed at:

http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf.

Among other issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

Requests for information regarding property under this contract should be directed to the following office:

Division of Logistics Services, NIH Property Management Branch 6011 Building, Suite 639

6011 EXECUTIVE BLVD MSC 7670

BETHESDA MD 20892-7670

nihcontractproperty@nih.gov

b. Notwithstanding the provisions outlined in the HHS Publication, "HHS Contracting Guide for Contract of Government Property," which is incorporated in this contract in paragraph a. above, the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

ARTICLE G.10. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on task orders in accordance with FAR Subpart 42.15. Performance evaluations will not be prepared on the parent IDIQ 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 fourteen 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.

http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf mailto:nihcontractproperty@nih.gov

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.cpars.gov/

SECTION H – SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract.

ARTICLE H.2. INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

Registration with the U. S. Department of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. The USDA office contact information is available at http://www.aphis.usda.gov. The USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), http://www.nal.usda.gov/awic/legislat/awa.htm.

The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH), http://grants2.nih.gov/grants/olaw/olaw.htm. An essential requirement of the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U.S. PHS.

The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the USDA under the Animal Welfare Act.

The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the accredited status.

As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC.

While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable.

AAALAC uses the Guide as its primary evaluation tool. It also uses the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federated of Animal Science Societies http://www.fass.org.

ARTICLE H.3. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL

SUBJECTS

The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the OLAW, establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS.