BARDA RFP 75A50122R00008_FINAL_(Amendment 2) signed.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

ASPR-BARDA

Jeffrey Brown

Amendment 2 to RFP 75A50122R00008 as follows:

1. Attachment to the Amendment include Questions and Answers

2. Incorporate updated RFP in accordance with the response to Question 1 of Q&A

ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G Washington D.C. 20201

75A50122R00008

1 108

05/5/2022

04/06/2022

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5/5/2022

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SOLICITATION

SECTION A – SOLICITATION/CONTRACT FORM

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

75A50122R00008

Issue Date:

April 6, 2022

Set Aside:

[X] No [ ] Yes, see SECTION L

Title: BARDA Nonclinical Development Biological 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 2:00 pm local time on May 20, 2022. Offers will be valid for 270 days unless a different period is specified by the offeror.

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:

Andrew Sargeant, Contract Specialist

(202) 868-0048 andrew.sargeant@hhs.gov Jeffrey Brown

Contracting Officer

CNCR, CMA, BARDA

(212) 730-8662 Jeffrey.brown@hhs.gov

Solicitation Number: 75A50122R00008

PART I – THE SCHEDULE

SECTION B – SERVICES AND COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES

The purpose of this Multiple Award Indefinite Delivery /Indefinite Quantity (IDIQ) contract is to maintain a Nonclinical Studies Network (NSN) of laboratories providing expertise, capacity, and program management across three capability areas:

Capability Area 1: Animal Model Development and MCM Testing (Biological Agents)

Capability Area 2: Analytical Method Development, Qualification, Validation, and Testing

Capability Area 3: Safety and Toxicity Testing

The NSN will be a key element in the successful development of medical countermeasures for biological threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. The United States Government (USG) therefore seeks appropriate facilities that are adequate and available to support establishing new or existing nonclinical models, and/or supportive reagents and assays for the development of medical countermeasures (MCMs) against biological threats, influenza and emerging infectious diseases, and for regulatory acceptance in the U.S. It is anticipated that fixed-price and cost reimbursement type task orders under the IDIQ contract will be issued to carry out nonclinical services.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Delivery /Indefinite Quantity contract as contemplated by FAR 16.504. Each 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 $100,000,000 (maximum) for successful performance of this contract. This contract ceiling is the Government’s most optimistic scenario with respect to the Government’s needs and level of funding.

b. The prices/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 order procedures are described in SECTION G of this contract.

ARTICLE B.2.1. MINIMUM ORDER GUARANTEE

The total minimum guarantee under this IDIQ contract is $75,000. This one-time amount will be issued upon award on the base contract. This amount or any remaining portion of this amount can only be claimed at the end of the 60-month period of performance if no task orders are received or task order received are less than $75,000, and if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one task order.

ARTICLE B.2.2. PRICING OF TASK ORDERS

The Government will issue Requests for Task Order Responses (RTORs) and contractors will compete for task orders for nonclinical services based on the work described in SECTION C of this contract. Upon delivery and acceptance of the services described in each task order, the Government shall pay to the Contractor the price, costs or fee set forth in the task order.

Individual task orders will be issued as requirements occur and will specify work to be performed. The Contractor shall perform all services in accordance with each task order’s work statement/specifications.

The terms and conditions under the base IDIQ contract are incorporated into all task orders issued pursuant to this contract.

Task Orders will consist of the following contract types: Cost-Plus-Fixed-Fee (CPFF) and Firm Fixed Price

(FFP).

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 (CO) 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 CO for that contract and not carry out the direction until a clarification has been issued by the CO.

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 CO 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/WORK STATEMENT

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 "Compliance Checklists."

a. IDIQ Contract Requirements (Note: Reporting requirements below can be found in table format in section F.2 Deliveries)

1. Meetings and Site Visits

i. Kick-Off Meeting

The Contractor shall complete a Kickoff meeting after contract award and/or within 30 calendar days of IDIQ contract award to be held at a location determined by the Contracting Officer’s Representative (COR). The purpose of the IDIQ contract kick-off meeting will be to review contract requirements and orient the contractor to HHS/BARDA IDIQ contract management as well as task/delivery order procedures.

ii. Annual Meetings

Annually within 30 calendar days of the anniversary of the contract award date, the Contractor shall arrange and may conduct 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.

Meeting materials submitted as part of the annual meeting (i.e. slide decks and summaries of contract activities) will constitute the annual report. In the case where formal annual meetings are unable to be held, similar documents must be submitted as an annual reporting requirement.

iii. Periodic Site Visits and Audits

Contractor shall accommodate periodic or ad hoc site visits by BARDA to include but not be limited to ASPR/BARDA security audits, quality assurance and compliance audits, study monitoring, and meetings to address performance under this contract.

If issues are identified during the audits or ad hoc meetings, Contractor shall submit a report to BARDA detailing the finding and corrective action(s) within 10 business days of the audit or site visit. The COR and Contracting Officer (CO) will review the report and provide a response to the Contractor with 10 business days of finding(s) notification. Once corrective action(s) is completed, the Contractor will provide a final report to BARDA.

iv. Subcontractor Site Visits and Audits

BARDA reserves the right to participate in audits/site visits performed by the contractor at proposed subcontractor sites providing capabilities and services under this IDIQ contract. This may include but not limited to site qualification, ASPR/BARDA security audits, and quality assurance and compliance audits and study monitoring. 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 with FDA guidance and/or regulations for Animal Rule Studies, 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 10 business days in advance of upcoming, audits/site visits of subcontractors.

Contractor shall deliver relevant site visit/audit report to COR and CO within 5 business days of report.

COR and CO will review the report and provide a response to the Contractor within 5 business days.

2. Annual Licensure/Registration Documentation

Mandatory qualification criteria for award under this solicitation include licensure/registration or regional equivalents for AAALAC accreditation, applicable USDA licenses/registration, OLAW assurances, and CDC Select Agent Registration as applicable to capability area proposed.

Contractor shall provide current documentation to support each relevant accreditation, licensure, or registration annually within 30 calendar days of contract anniversary date.

3. Press Releases

The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The contractor shall ensure that the Contracting Officer and Contracting Officer Representative has received and approved an advanced copy of any press release to this contract; not less than 5 business days prior to the issuance of the press release.

4. Publications

Any manuscript or scientific meeting abstract containing reference to efforts under this contract including but not limited to study designs, development efforts, or data generated must be submitted to the COR for review prior to submission. The contractor shall ensure that the CO has received and approved an advanced copy of any relevant manuscript/abstract to this contract not less than 30 calendar days in advance of submission date for manuscripts and 15 calendar days in advance of submission date for abstracts.

5. FDA Reporting and Meeting Requirements

The following applies to US Food and Drug Administration interactions with contractors or subcontractors relevant to or inclusive of work conducted or data produced within task order(s) under this contract.

i. FDA Meetings

Within 5 business days of meeting confirmation, the Contractor shall forward dates and times of any meeting with the FDA to the COR and make arrangements for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people (COR, CO, and up to 2 subject matter experts) within FDA’s discretion.

ii. FDA Correspondence and Meeting Summaries

Within 5 business days of receipt, the Contractor shall forward all correspondence from the FDA, such as initial Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER) issued draft minutes and final minutes of any meeting, to the COR. All documents shall be duly marked as either ‘Draft’ or ‘Final’.

iii. FDA Submissions

The Contractor shall provide the COR the opportunity to review and comment upon all draft regulatory documents prior to submission to the FDA. The Contractor shall provide BARDA 5 business days review period. The Contractor shall provide the COR with an electronic copy of the final FDA submission within 5 business days of submission. All documents shall be duly marked as either 'Draft' or 'Final'.

iv. FDA Inspections & Audits

The Contractor shall notify the COR and CO within 24 hours of FDA's arrival to conduct site visits/audits.

In the event of an FDA inspection which occurs as a result of this contract, 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). These reports and forms are due to the CO and COR within 5 business days of receipt. The Contractor shall provide the CO and COR copies of the plan for addressing areas of non-conformance identified in the audit report, status updates during the plan’s 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.

6. Other Regulatory Agency Audits/Inspections

The contractor shall provide BARDA with an electronic copy of all state, local and federal agency (e.g. CDC, OLAW, USDA) inspection reports related to the contractor’s ability to perform under this contract (i.e. select agent or animal welfare inspections). Upon BARDA request, the Contractor shall provide subsequent contractor responses and corrective action plans submitted in response to these inspection reports.

The contractor shall provide inspection reports within 10 business days of receipt.

Responses and corrective action plans shall be provided within 5 business days of submission to federal agencies.

7. 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 CO 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)

8. Information Security Reporting Requirements

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

i. 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 COR, with a copy to the CO, within 14 days of the effective date of the contract.

ii. Reporting of New and Departing Employees

The Contractor shall notify the COR and CO within 7 days before staffing changes for positions that require suitability determinations as follows:

1. 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.

2. 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 CO upon request.

iii. 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, attached in Section J, ATTACHMENTS of this contract, 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 CO within 14 days of the effective date of the contract.

iv. Contract Deliverables Due at Expiration

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

1. 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 HHS 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.

2. 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.

9. Government Information Processes 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.

i. Security Assessment and Authorization (SA&A) Package Deliverables:

1. System Security Plan.

2. Security Assessment Plan/Report.

3. Independent Assessment.

4. Plan of Actions and Milestones.

5. Contingency Plan and Contingency Plan Test.

6. E-Authentication Questionnaire.

ii. Information Security Continuous Monitoring Deliverables:

1. Annual Assessment/Pen Test.

2. Asset Management.

3. Configuration Management.

4. Vulnerability Management.

10. Service Contract Reporting Requirements for Indefinite-Delivery Contracts

The Contractor shall report annually (October 31) 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.4. ADDITIONAL CONTRACT CLAUSES of this contract and the DELIVERIES Article in SECTION F of this contract.

11. 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 include, but are not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the CO.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F annually on contract anniversary date.

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 CO at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, HHS 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 at http://www.iedison.gov.

12. 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.

b. Task/Delivery Order Requirements

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

1. Meetings and Site Visits

i. Kickoff and Technical Meetings

The contractor shall plan and conduct a kickoff meeting and periodic technical meetings to include the contractor’s project team, COR and CO as well as other BARDA personnel deemed appropriate by the COR. At a minimum, a technical meeting will occur monthly 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 and provide a summary of all meetings and teleconferences in a timely manner.

ii. Periodic Site Visits and Audits

Contractor shall accommodate periodic or ad hoc site visits by BARDA to include but not limited to quality assurance and compliance audits, study monitoring, and meetings to address performance of task orders awarded under this contract.

iii. Subcontractor Site Visits and Audits

BARDA reserves the right to participate in audits/site visits performed by the contractor at subcontractor sites providing capabilities and services performed under task orders.

2. Technical Progress Reports

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

i. An Executive Summary highlighting the progress, relevant activities, and critical issues for that reporting period and resolution approach.

ii. 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 discrepancies between the two, and the corrective steps and actions planned, if behind schedule.

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

iv. 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.

v. Estimated and Actual Expenses

1. 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.

2. 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.

vi. Milestones will be identified for each Task/Delivery Order and progress toward each Milestone will be reported as part of the Technical Progress Report.

3. 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:

i. Nonclinical program and study design overviews with Gantt chart demonstrating temporal relationship between studies

ii. Draft and final SOWs to be sent to subcontractors

iii. Draft and final protocols

iv. Draft and Final Reports

4. Standard Operating Procedures

At the request of the COR, the contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically for procedures relevant to work conducted under task order.

5. Data

At the request of the COR, the Contractor shall provide data (either interim or final) in formats compatible with USG systems for independent analysis. Quality Control status of data shall be indicated within electronic file name.

SECTION D – PACKAGING, MARKING, AND SHIPPING

Unless otherwise specified by the Contracting Officer (CO), all deliverable items to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email, as described in Section F.

All deliverables shall be preserved, packaged, and marked in accordance with normal commercial practices to meet the packaging requirements of the carrier, including that which is necessary to prevent deterioration and damages due to the hazard of shipping, handling, and storing. 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 (CO) 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 (COR) is the authorized representative of the CO.

3. Technical Inspection and acceptance will be performed at:

Biomedical Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services (DHHS) Tipp O’Neill House Office Building Room 24F15 Washington, DC 20201

Acceptance may be presumed unless otherwise indicated in writing by the CO 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 CO 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 PERFORMANCE

ARTICLE F.1. ORDERING PERIOD

The ordering period for this contract shall include a five-year base period from the effective date of award.

ARTICLE 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

IDIQ Contract Requirements

1.0 Meetings and Site Visits

1.i. Kickoff Meeting Location determined in consultation with the COR

Within 30 calendar days of contract award

1.ii. Annual Meetings Location determined in consultation with the COR

Annually within 30 days of the anniversary of the contract award date

1.iii. Periodic Site Visits and Audits Site visit or audit conducted at contractor facilities

Occur on an ad hoc basis.

Summary of findings and corrective actions provided within 10 business days of audit or site visit.

1.iv. Subcontractor Site Visits and Audits Site visit or audit conducted at subcontractor facilities

Occur on an ad hoc basis.

Site visit or audit notification to CO 10 business days in advance.

Audit report to CO and COR within 5 business days.

BARDA shall provide comments within 5 business days after receipt.

2.0 Annual Licensure/Registration

Documentation to include:

AAALAC accreditation or equivalent

Applicable USDA licensure/registration or equivalent

Electronically to CO

& COR

Annually within 30 days of the anniversary of the contract award date

OLAW assurance CDC Select Agent Registration or equivalent

3.0 Press Releases Electronically to CO

& COR

Not less than 5 business days prior to the issuance

4.0 Publications Electronically to CO

& COR

30 calendar days in advance of submission date for manuscripts and 15 calendar days in advance of submission date for abstracts.

5.0 FDA Reporting and Meeting Requirements

5.i. FDA Meetings Email to CO & COR Confirmed meeting dates forwarded within 5 business days of receipt.

5.ii. FDA Correspondence and Meeting Summaries

Electronically to CO

& COR

Within 5 business days of receipt

5.iii. FDA Submissions Electronically to CO

& COR

Prior to submission to FDA.

BARDA provided 5 business days to review and comment

5.iv. FDA Inspections & Audits Electronically to CO

& COR

Notify CO & COR within 24 hours of FDA arrival for inspection.

Inspection reports and forms due to CO & COR within 5 business days of receipt.

6.0 Other Regulatory Agency

Audits/Inspections

Electronically to CO

& COR

Within 10 business days of receipt. Responses and corrective action plans shall be provided within 5 business days of submission to federal agencies.

7.0 Reporting of Financial Conflict of

Interest

Electronically to CO

& COR

In accordance with 45 CFR Part 94

8.0 Information Security Reporting Requirements

8.i. Roster of Employees Requiring

Suitability Investigations Electronically to CO

& COR

Within 14 days after the effective date of the contract

8.ii. Reporting of New and Departing Employees

Electronically to CO

& COR

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

8.iii. Contractor – Employee Non-Disclosure Agreement(s)

Electronically to CO

& COR

Within 14 days after the effective date of the contract

8.iv.1 Sanitization of Government Files and Information

Electronically to CO

& COR

On or before contract expiration

8.iv.2 Contractor Responsibilities Upon Physical Completion of the Contract

Electronically to CO

& COR

On or before contract expiration

9.0 Government Information Processes on GOCO or COCO Systems

9.i.1. System Security Plan Electronically to CO

& COR

Within 30 days after contract award

9.i.2. Security Assessment Plan/Report

(SAP/SAR)

Electronically to CO

& COR

Within 30 days after contract award

9.i.3. Independent Assessment Electronically to CO

& COR

Within 90 days after contract award

9.i.4. POA&M Electronically to CO

& COR

Within 30 days after contract award

9.i.5. Contingency Plan and Contingency Plan Test

Electronically to CO

& COR

Within 60 days after contract award

9.i.6. E-Authentication Questionnaire Electronically to CO

& COR

Within 60 days after contract award

9.ii.1. Annual Assessment/Pen Test Electronically to CO

& COR

Annually on contract anniversary

9.ii.2. Assess Management Inventory Report Electronically to CO

& COR

Within 60 days after contract award

9.ii.3. Configuration Management Compliance Electronically to CO

& COR

Within 60 days after contract award

9.ii.4. Vulnerability Management Capability Notice

Electronically to CO

& COR

Within 30 days after contract award

10.0 Service Contract Reporting

Requirements for Indefinite-Delivery Contracts

Electronically to sam.gov

Annually on October 31

11.0 Invention Reporting Requirement –

Annual Utilization Report

Electronically to CO Annually on contract anniversary date

12.0 Final Closeout Report Electronically to CO

& COR

45 days prior to contract expiration date

Task/Delivery Order Requirements

1.0 Meetings and Site Visits

1.i. Kickoff and Technical Meetings Location determined in consultation with the COR

Defined in Task/Delivery Order

1.ii. Periodic Site Visits and Audits Site visit or audit conducted at contractor facilities

Defined in Task/Delivery Order

1.iii. Subcontractor Site Visits and Audits Site visit or audit conducted at

Defined in Task/Delivery Order subcontractor facilities

2.0 Technical Progress Reports Electronically to CO

& COR

Monthly as defined in Task Delivery Order

3.0 Technical Documents Electronically to CO

& COR

Defined in Task/Delivery Order

4.0 Standard Operating Procedures Electronically to CO

& COR

Defined in Task/Delivery Order

5.0 Data Electronically to CO

& COR

Defined in Task/Delivery Order

ARTICLE F.3. INVOICING

The Contractor shall submit an electronic copy addressed in the format indicated in G.6, shall follow the detailed invoicing instructions listed in Section J, and include an SF-1034. The contractor shall submit the payment request in accordance with the following HHSAR Clause 352.232-71.

The Government may request additional information (timecards, receipts, etc.) to support costs claimed in the Contractor’s invoices. Incomplete invoices may be suspended by the CO if the Contractor’s claimed costs cannot be substantiated.

ARTICLE F.4. 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 CO 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.

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.

Jeffrey Brown – (202) 868-9869 – Jeffrey.brown@hhs.gov Lead Contracting Officer Division of Contracts Management & Acquisition (CMA) Biomedical Advanced Research & Development Authority (BARDA)

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; (6) otherwise change any terms and conditions of this contract; or (7) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the 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 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 CO 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 CO. 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 CO, 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

CO.

b. Requesting Task Order Proposals

The CO 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 within the IDIQ contracts will flow down to the RTORs 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. Contractors 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 CO 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 CO, in…