RFP_75A50119R00026_CTPE_(9.6.2019).pdf

75A50119R00026

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 102

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) depository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

09/06/2019 X

ASPR-BARDA

ASPR-BARDA

O'Neill House Office Building Room 24F15 Washington DC 20515 until 1200 ET local time 10/21/2019

JEFFREY E BROWN

Jeffrey.Brown@hhs.gov

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PAGE(S)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

6-10 11-18 21-28 29-33 34-58

59-73

75-79

80-94 95-102

3 hardcopies and 1 electronic

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____120________ calendar days (60 calendar days unless a different period is inserted see Section L.3. of RFP

202 730-8662

TABLE OF CONTENTS

B. SUPPLIES / SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES / SERVICES

B.2. SPECIFIC REQUIREMENTS

B.3. CONTRACT TYPE

B.4. BASE PERIOD CONTRACT LINE ITEM NUMBER (CLIN)

B.5. OPTION PERIOD CONTRACT LINE ITEM NUMBERS (CLINs)

B.6. ADVANCED UNDERSTANDINGS

B.7. INVOICING INSTRUCTIONS

C. STATEMENT OF OBJECTIVES

C.1. INTRODUCTION / BACKGROUND

C.2. STATEMENT OF OBJECTIVES

C.3. TECHNICAL REQUIREMENTS

C.4. MEETINGS

C.5. REPORTING REQUIREMENTS

C.6. CONTINUITY PLANNING REQUIREMENTS

C.7. SECURITY PLAN

D. PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

E. INSPECTION AND ACCEPTANCE

E.1. FEDERAL ACQUISITION REGULATIONS INCORPORATED BY REFERENCE

E.2. GOVERNMENT RESPONSIBILITIES FOR INSPECTION AND ACCEPTANCE

E.3. PERSON-IN-PLANT

E.4. AUDITS

F. DELIVERIES / PERFORMANCE

F.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

F.2. PERIOD OF PERFORMANCE

F.3. DELIVERIES

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.5. DELIVERABLE SCHEDULE

G. CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER

G.2. CONTRACTING OFFICER’S REPRESENTATIVE

G.3. DELIVERIES

RFP 75A50119R00026

G.4. CONTRACTOR’S POINT OF CONTACT

G.5. ORDERING PROCEDURES

G.6. INVOICE SUBMISSION

G.7. CONTRACT COMMUNICATIONS / CORRESPONDENCE

G.8. POST-AWARD EVALUATION OF CONTRACT PERFORMANCE

G.9. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

G.10. NEGOTIATED INDIRECT RATES AND CEILING

G.11. Government Property

H. SPECIAL CONTRACT REQUIREMENTS

H.1. ACCESS AND DISPOSITION OF DATA

H.2. KEY PERSONNEL

H.3. SUBSTITUTION OF KEY PERSONNEL

H.4. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

H.5. CERTIFICATE OF CONFIDENTIALITY

H.6. CLINICAL RESEARCH

H.7. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

H.8. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

H.9. NEEDLE DISTRIBUTION

H.10. ACKNOWLEDGEMENT OF FEDERAL FUNDING – PUBLICATION AND PUBLICITY

H.11. RESTRICTION ON ABORTIONS

H.12. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

H.13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

H.14. OPTION PROVISION

H.15. DESIGNATION OF OMBUDSMAN

H.16. SUBCONTRACTING PROVISIONS

H.17. CONFIDENTIALITY OF INFORMATION

H.18. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

H.19. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

H.20. POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

H.21. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

H.22. ACCESS TO DOCUMENTATION / DATA

H.23. IN-PROCESS REVIEW

H.24. IDENTIFICATION AND DISPOSITION OF DATA

H.25. DISSEMINATION OF INFORMATION

H.26. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR 352.239-73 (December 2015)

H.27. INFORMATION SECURITY

I. CONTRACT CLAUSES

I.1. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

I.2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) CLAUSES 62

I.3. ADDITIONAL CONTRACT CLAUSES

J. LIST OF ATTACHMENTS

K. REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

K.1. FAR 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (OCT 2018)

L. INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

L.1. SOLICITATION PROVISIONS INCORPORATED BY REFERENCE INCORPORATED BY REFERENCE

L.2. FAR 52.216-1 TYPE OF CONTRACT (Apr 1984)

L.3. DELIVERY AND PACKAGING OF PROPOSALS

L.4. TECHNICAL PROPOSAL

L.5. BUSINESS PROPOSAL

L.6. OTHER ADMINISTRATIVE DATA

L.7. INQUIRIES

L.8. INCURRING COSTS

L.9. NAICS CODE AND SIZE STANDARD

L.10. THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS

L.11. USE OF THE METRIC SYSTEM OF MEASUREMENT

L.12. POTENTIAL AWARD WITHOUT DISCUSSIONS

L.13. COMMITMENT OF PERSONNEL

M. EVALUATION FACTORS FOR AWARD

M.1. BASIS OF AWARD

M.2. COST / PRICE EVALUATION

M.3. PRE-AWARD SITE VISIT / SITE AUDIT

M.4. TECHNICAL CRITERIA

M.5. TECHNICAL PLAN/APPROACH, ORGANIZATIONAL EXPERIENCE & COMPETENCY, AND KEY

PERSONNEL QUALIFICATIONS RATINGS

TECHNICAL APPROACH, ORGANIZATIONAL EXPERIENCE & COMPETENCY, AND KEY PERSONNEL MERIT

RATINGS

M.6. PAST PERFORMANCE

M.7. SMALL BUSINESS (SB) SUBCONTRACTING PLAN

M.8. EVALUATION OF OPTIONS

M.9. BUSINESS PROPOSAL EVALUATION

B. SUPPLIES / SERVICE AND PRICE / COST

Medical Countermeasures Clinical Studies Network

B.1. BRIEF DESCRIPTION OF SUPPLIES / SERVICES

This Request for Proposals (RFP) solicits proposals for multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts for a Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE) Contract Research Organization (CRO) to execute routine and/or response clinical services for advanced development of medical countermeasures (MCMs) in support of the Biomedical Advanced Research and Development Authority (BARDA) mission. With this solicitation, BARDA seeks to modify the current CSN infrastructure and extend services available for advanced clinical development of MCMs. The revised infrastructure will address additional requirements recognized during operation of the CSN since it was established. It will enhance the capabilities of the existing CSN and add services to be utilized across studies by adding a Biological Specimen and Investigational Product storage facility (BSIP) and a Statistical and Data Coordinating Center (SDCC). In order to enhance BARDA’s preparedness and response to chemical, biological, radiological and nuclear (CBRN); pandemic influenza (PI) and emerging infectious diseases (EID) threats BARDA seeks a diverse pool of CROs or similar entities to provide CTPE services as primary contactors. Service capabilities include project management, study start up, site training and support, site feasibility and selection, site monitoring and management, specimen and Investigational Product (IP) management, laboratory services, regulatory services including but not limited to Investigational New Drug Application (IND) and Amendment publishing and Food and Drug Administration (FDA) submission, Institutional Review Board services, quality assurance, as well as other services. During emergencies, services need to be rapid, adaptable, scientifically robust, and minimally disruptive to the course of patient care. Considerations for executing such services need to include:

1. Phase of the study in relation to the development stage of the MCM investigational product (Phase 1, Phase 2, Phase 3, or Phase 4)

2. The type of study (e.g., interventional or observational studies)

3. The requirement for near real-time data availability

4. The scale of the emergency (e.g., national versus local versus international)

5. The class of MCM (e.g., drug, biologic, device, or combination product)

BARDA acknowledges that some Respondents may have strengths in providing these services in the conduct of routine studies, while others may have strengths preparing for and operating in response (i.e., emergency) scenarios. Therefore, BARDA intends to evaluate Respondents separately for these two capabilities. Offerors may respond to one or to both capabilities.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) to support development and acquisition of MCMs to prevent or treat the medical consequences of CBRN threats, PI, and EID. These MCMs include vaccines, therapeutics, diagnostics, and medical devices. BARDA established the Clinical Studies Network (CSN) as a core service in 2012 and awarded IDIQ contracts to five (5) full service clinical contract research organizations (CROs) in 2014 to form the CSN infrastructure. During the five (5) years of the CSN’s existence, several important gaps in capabilities were identified. In addition to this RFP for clinical trial preparation and execution (CTPE) services, two (2) other separate and distinct solicitations will seek to address these gaps as follows:

1. RFP No. 75A50119R00027 – Seeks offers to address the requirements for a centralized Statistical and Data Coordination Center (SDCC); and

2. RFP No. 75A50119R00028 – Seeks offers to address the requirements for a Biological Specimen and Investigational Product storage facility (BSIP)

The objectives of those two solicitations are to establish a Biological Specimen and Investigational Product (BSIP) storage facility and a Statistical and Data Coordinating Center (SDCC). This solicitation addresses additional requirements for CTPE services on a routine basis without expedited timelines, as well as services to prepare for and execute clinical studies during emergencies when expedited timelines are crucial. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA Clinical Studies Network (CSN).

B.2. SPECIFIC REQUIREMENTS

Clinical Studies Network Clinical Trial Planning & Execution (Routine and Response)

With this solicitation, BARDA seeks to modify the current CSN infrastructure and extend services available for advanced clinical development of MCMs. With this solicitation, BARDA CSN seeks to:

• Provide a clinical study core service for use on a routine (Routine Services) or response (Response Services) basis by BARDA and by BARDA’s product development partners.

• Enhance BARDA’s preparedness and response to CBRN, PI and EID threats.

• Promptly complete clinical activities supporting regulatory applications including but not limited to Emergency Use Authorization (EUA).

• Improve financial management of clinical trials and potentially reduce the MCM clinical development costs to BARDA.

• Reduce the risk associated with clinical development of investigational or repurposed products by expanding the available clinical data.

PLEASE NOTE:

• Potential Offerors are not expected to be proficient in all areas mentioned in the Statement of Objectives (SOO).

• Partnering and teaming arrangements are encouraged.

• Multiple awards are anticipated with selection of large, full service, small, and specialty

CROs.

• After IDIQ award Contractor is required to submit a proposal for at least:

o 80% of the Requests for Task Order Response (RTORs) if submitting a proposal for Routine Services o 100% of the RTORs if submitting a proposal for Response Services

• Contractor must acknowledge receipt of all RTORs issued under the relevant IDIQ CTPE service area.

• Contractor must provide an substantive justification for not submitting a proposal in response to RTORs issued under relevant IDIQ CTPE service area.

B.3. CONTRACT TYPE

The United States Government (USG) intends to award multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts for both Routine Services and/or Response services identified in the Specific Requirements above. During the period of performance of the contract, the Government may order, and the Contractor shall provide, services as identified in future Task Orders. At the discretion of the Government, Task Orders issued under this contract may be Firm-Fixed Price (FFP) and/or Cost Reimbursement.

Each Request for Task Order Response (RTOR) under the IDIQ will specify its own period of performance, task order type, and scope of work.

B.4. BASE PERIOD CONTRACT LINE ITEM NUMBER (CLIN)

The Base Period of Performance (PoP) shall be two (2) years from date of award, and shall be composed of a “Not to Exceed” CLIN to be used for potential task order awards.

BASE PERIOD (2 Years)

CLIN # Description Task Order Budget*

0001 Clinical Studies Network Task Orders TBD

*TBD: Task Order business proposals shall include labor rate costs, facility costs, and all other cost components necessary to complete clinical study services. Each RTOR will clearly delineate proposal requirements, to include contract type.

B.5. OPTION PERIOD CONTRACT LINE ITEM NUMBERS (CLINs)

The final contract will contain Option Period CLINs agreed upon by the Government and Offeror. If exercised, each Option Period shall be one (1) year.

OPTION PERIODS

CLIN # Description Task Order Budget*

0002 Option Year 1: Clinical Studies Network Task Orders TBD

0003 Option Year 2: Clinical Studies Network Task Orders TBD

0004 Option Year 3: Clinical Studies Network Task Orders TBD

*TBD: Task Order business proposals shall include labor rate costs, facility costs, and all other cost components necessary to complete clinical study services. Each RTOR will clearly delineate proposal requirements, to include contract type.

B.6. ADVANCED UNDERSTANDINGS

B.6.1. Minimum Order Amount - $1,000 The minimum order amount for any single task order issued, shall not be under $1,000.

B.6.2. Maximum Ordering Amount - $250,000,000 The maximum ordering limitation for a single task order or combination of task orders, within the entire period of performance, inclusive of any exercised option periods, is $250,000,000.

The Contractor shall not receive payment from the Government in any amount greater than said maximum, for successful performance under this contract.

B.6.3. Minimum Guarantee - $200,000 The minimum guarantee under the IDIQ is $200,000. In the event that a Contractor does not receive a task order award, or is awarded a task order(s) below the $200,000 guarantee, said minimum, minus the amount of any task order(s) performed by the Contractor within the overall period of performance, becomes payable to the Contractor when the base period or last exercised option period expires. This amount can only be claimed at the end of the period of performance, if the Contractor takes advantage of fair opportunity, as described in FAR 16.505, by proposing on at least 80% of task orders for Routine Services and/or 100% of task orders for Response Services, and providing a clear explanation for not submitting a proposal in response to RTORs.

In the case where the Government decides to not exercise one or more option periods, the minimum guarantee shall be prorated by the number of years that the Contractor remained under contract.

B.6.4. Task Order Funding Funds for Government requirements will be obligated at the task order level, as task order awards are issued. Excess funds will be de-obligated at the task order level, by the Government, via unilateral modification. The Contractor shall only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed.

B.6.5. Provisions Applicable to Costs This section prohibits or restricts the use of contract funds for the following, unless otherwise approved in advance by the Contracting Officer:

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

2. Rearrangement or alteration of facilities;

3. Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value;

4. Accountable Government Property;

5. Overtime;

6. General scientific meetings/conferences;

7. Travel costs, including foreign travel;

8. Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

9. Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000;

10. Refreshments and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative

(COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meetings, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a Government facility.

B.7. INVOICING INSTRUCTIONS

Invoices for payment shall be submitted to the Contracting Officer and Contracting Officer’s Representative, as one (1) hard copy and one (1) electronic copy addressed in the format indicated in G.3, shall follow the detailed invoicing instructions attached as part of Section J, and include a form SF- 1034.

The electronic version of the invoice can be submitted via e-mail or uploaded through HHS’ eRoom (shared access may be provided to the Contractor after award).

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 Contracting Officer if the Contractor’s claimed costs cannot be substantiated.

[The Remainder of the Page Intentionally Left Blank]

C. STATEMENT OF OBJECTIVES

Clinical Studies Network – Clinical Trial Planning & Execution (CTPE)

C.1. INTRODUCTION / BACKGROUND

The purpose of this Request for Proposals is to solicit applications for Clinical Trial Planning and Execution (CTPE) services for the Biomedical Advanced Research and Development Authority (BARDA) Clinical Studies Network (CSN). The purpose of the CSN is to advance the development of life saving MCMs by efficiently enabling rigorous clinical trials to assess safety and efficacy of drugs, devices, and biological products. BARDA established the CSN as a core service in 2012 and awarded Indefinite Delivery/ Indefinite Quantity (IDIQ) Contracts to five (5) full service CROs in 2014 to form the CSN infrastructure. The CSN will provide a robust and readily accessible infrastructure for rapid implementation and high quality performance of clinical trials as well as provide other services in a breadth of indications related to development of MCMs. The infrastructure should be sufficient for performing approximately four simultaneous clinical trials. The CSN will consist of several clinical contract research organizations (CROs) for routine and response clinical studies. Two companion solicitations will address the need for a Statistical and Data Coordinating Center (SDCC) and for a Biological Specimen and Investigational Product storage facility (BSIP). Offerors are encouraged to respond to one, two or all three solicitations if they are able to provide the required services directly or indirectly through subcontractors.

FOR PROPOSAL PURPOSES ONLY: CTPE Offerors should provide capabilities for all items listed in the SOO even if it is duplicated in the SDCC RFP SOO. Post award, specific requirements per RTOR will be assigned to the CTPE contractor or SDCC contractor in the individual RTOR SOO.

BARDA will award base contracts to support the CSN infrastructure. Task Orders will be issued for specific clinical study-related services when needed to support MCM development.

C.2. STATEMENT OF OBJECTIVES

Objective 1

The Offeror shall provide clinical trial planning and execution services to BARDA. These studies will clinically evaluate CBRN, PI and/or EID MCMs. These studies may be Phase 1, 2, 3, or 4 (as defined by the FDA) or combinations of these phases.

Objective 2

There will be two types of RTORs:

1. For routine (i.e., preparedness) clinical trial planning and execution with non-expedited timelines

2. For response (i.e., emergency) clinical trial planning and execution in urgent situations with expedited timelines such as during an emergency.

BARDA acknowledges that some Offerors may have strengths providing services in the conduct of routine studies, while others may have strengths operating in response scenarios. Therefore, BARDA intends to make independent evaluations and separate awards for these two capabilities; in responding to this RFP, Offerors may respond to one or to both.

C.3. TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Objectives. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

This contract is for the establishment of CTPE services on a routine basis without expedited timelines, as well as services to prepare for and execute clinical studies during emergencies when expedited timelines are crucial. All work performed under this contract must be done in compliance with federal and/or local regulations.

Task Orders may be issued for work substantially as follows:

C.3.1. Routine Clinical Trial Planning and Execution Task Orders for routine clinical trial planning and execution will be for services to support activities related to the conduct of clinical trials without critically short timelines. Those services include but are not limited to those listed below.

BARDA will specify in the task order (1) whether an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application or equivalent should be submitted to an appropriate regulatory agency; (2) the entity that will hold the IND/IDE; and (3) whether a Data and Safety Monitoring Board1 (DSMB) is required.

The Contractor shall provide the following services (for each of the following, specify whether these are in-house or outsourced capabilities):

1. Project Management and Administration

1.1. Develop a Project Management Plan that describes the relationships, accountabilities, communications, and oversight of coordination of the collaborative activities of the CTPE CRO as well as the SDCC and the BSIP contractors, BARDA, other partners and collaborators, vendors, and sub-contractors during study planning, start-up, execution, and close-out.

1.2. Development and maintenance of Responsible, Accountable, Copied, Informed (RACI)/Study Responsibility Matrix outlining responsibilities for key activities and deliverables (specific roles for BARDA, the CSN contractors and subcontractors will be established at the time of each Task Order).

1.3. Comprehensive study timelines in MS Project for each study.

1 Within this document, DSMB is inclusive of any Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC), DSMB, or additional monitoring committee terminology.

1.4. Secure (21 CFR Part 11 compliant validated), study-specific internet based portal that is password protected with managed user access roles.

1.5. Written project status reports according to pre-specified schedules.

1.6. Schedule, develop agenda, and lead team meetings. Author and distribute meeting minutes documenting key discussions, decisions, action items and persons responsible.

2. Planning and Pre-study Activities

2.1. Establish an identified project team that may include a project manager, clinical trial manager, clinical research associate, medical monitor, pharmacovigilance specialist, regulatory specialist, medical writer, supplies and laboratory/specimens specialist, statistical/data management specialist, and quality specialist.

2.2. Protocol development and writing support services, including the development of protocol-related documents such as sample informed consents.

2.3. Negotiate and execute all clinical trial agreements and site budgets.

2.4. Secure clinical trial insurance appropriate for the study and population

2.5. Author, as needed, internal Standard Operating Procedures (SOPs) associated with processes necessary to comply with the FDA and Sponsor established requirements. Provide BARDA access to CRO SOPs for review.

2.6. Purchase all necessary equipment and clinical/laboratory supplies.

2.7. Provide sites with study supplies and materials.

2.8. Develop study procedures manual and other manuals as necessary.

2.9. Perform site feasibility and site selection including evaluation of investigator and research staff qualifications, facilities, and laboratory capabilities, site logistics, and infrastructure.

2.10. Determine what type of Institutional Review Board (IRB)/ Ethics Committee (EC) can be utilized and coordinate all aspects of selecting IRB.

2.11. Have current access to a network of sites/investigators available to perform clinical studies including sites with access to special populations such as the elderly, immuno-compromised, neurologically impaired, children and infants.

2.12. Identify and establish contractual agreements with clinical research vendors to support studies as needed, including but not limited to:

2.12.1. Clinical laboratories for biological sample management and chain of custody.

2.12.1.1. Pre-qualify central laboratories for validated assays.

2.12.1.2. Establish a validated specimen tracking and report system.

2.12.1.3. Establish processes in a study-specific manual for handling of specimens: collection, processing, shipping and receipt, final specimen disposition and reconciliation.

2.12.1.4. Coordiante sample management and shipping to BSIP contractor.

2.12.1.5. Obtain local laboratory ranges, qualifications, and certifications, including CLIA.

2.12.1.6. Conducted under current Good Clinical Laboratory Practice (GCLP) as necessary.

2.12.1.7. Obtain necessary approvals for export of biological specimens as allowed by regulatory authorities.

2.12.2. Investigational product (IP) or device management.

2.12.2.1. Develop and implement a study supplies procurement and management plan as well as Investigational Product or Device Accountability Plan

2.12.2.2. Obtain necessary approvals for import of IP and clinical trial materials or devices including storage and shipment.

2.12.2.3. Ensure IP or device is labeled as investigational, according to IND/IDE requirements.

3. Medical and Safety Monitoring

3.1. Develop and implement plans for providing 24 hour medical monitoring support with qualified medical monitors trained in the appropriate therapeutic area.

3.2. Identify independent DSMB members and provide qualifications for sponsor approval.

3.3. Develop and implement plans for safety assessment and safety monitoring/pharmacovigilance activities including identification, reporting and tracking systems for AEs, SAEs, study pausing/stopping rules, etc.

3.3.1. Include an unblinding plan consistent with International Conference on Harmonization E6 (R2) (e.g., to accommodate safety regulatory requirements).

4. Regulatory Services

4.1. Per BARDA’s request, author the following documents utilizing BARDA’s

StartingPoint Common Technical Document (CTD) templates for BARDA’s review and provide submission ready, including but not limited to the following:

4.1.1. Pre-IND

4.1.2. Original IND submission including, but not limited to general investigational plan; study rationale; chemical, manufacturing and controls (CMC); preclinical and clinical documents and summaries

4.1.3. Protocol amendments

4.1.4. Safety reports

4.1.5. IND annual reports

4.2. Update CTD build list in real time for needed submission documents, delivery dates, and Offeror’s dates as submission build progresses.

4.3. As directed by BARDA, perform quality control, publish, and transmit FDA submissions, which are compliant with electronic CTD (eCTD) specifications and all applicable regulatory requirements. Submission documents shall include, but are not limited to the following:

4.3.1. Briefing documents

4.3.2. Meeting requests

4.3.3. Meeting packages

4.3.4. Pre-IND submissions

4.3.5. IND submissions

4.3.6. BLA Applications

4.3.7. 510K Applications

4.3.8. Protocol amendments

4.3.9. Safety reports

4.3.10. Responses to FDA requests for information

4.3.11. IND annual reports.

4.4. Provide BARDA access to an eCTD viewing tool to view BARDA’s published submissions before submitting via the FDA gateway.

4.5. Provide BARDA direct access to any sub-contractor preforming publishing and FDA submission activities.

4.6. Allow BARDA cumulative review of submissions in the eCTD viewing tool when safety reports have been submitted and reviewers are blinded. (Note: BARDA will work with the Offeror to develop a process that ensures no inadvertent unblinding, and the viewing tool should be flexible to enable this.)

4.7. Validate eCTD submissions and provide to BARDA the complete validation report before final authorization to submit to FDA.

4.8. Provide BARDA FDA Electronic Submission Gateway Receipt and Acknowledgement.

4.9. Provide a concatenated submission document to BARDA to be used for BARDA printing and archiving.

4.10. Provide key information to investigators required for conduct of the study including, but not limited to, Investigator brochure (IB), revised IB, and adverse events.

4.11. As directed by the Sponsor, provide information to manufacturer about investigational product.

4.12. Collect and review Regulatory Essential Document Packet for site activation.

4.13. Manage electronic Trial Master File (eTMF), which includes the following:

4.13.1. Create eTMF index

4.13.2. Set up and maintain eTMF

4.13.3. Conduct periodic eTMF audits

4.13.4. Final eTMF Quality Control, archiving, and document return

4.14. Register and provide information for clinical studies to ClinicalTrials.gov Protocol Registration and Results System (PRS) as well as country-specific applicable registries.

4.15. Identify and contract with regulatory support personnel in US and possibly other countries to assist with obtaining necessary regulatory approvals.

4.16. For countries outside the US, serve as primary in-country agent representing sponsor to the competent authorities, ethics committees and other regulatory bodies; manage and track all regulatory communications; serve as regulatory point of contact, interact with competent authority and negotiate on behalf of Sponsor;

track, manage, and implement plan for all regulatory deliverables.

4.17. Submit study documents and obtain approval and annual renewals from a central Institutional Review Board (IRB) and as required from national and local agencies/committees in other countries as appropriate.

5. Quality Assurance and Audits

5.1. Development and implementation of an effective internal Quality Assurance and

Quality Control and Audit plan for all of the Offeror’s coordinating and document preparation activities ensuring compliance with federal and local regulations, and the ethics committee approved protocol.

5.2. An established internal system to measure, monitor and improve the level of performance of the personnel responsible for direct management of the sites (e.g.

on site and central monitoring activities, CTA essential records management) and the contractor/subcontractor staff.

5.3. Provide capabilities for on-site auditing of clinical trial sites and vendors (subcontractors) including drafting and submission of audit plans and reports.

5.4. Maintain inspection readiness state.

6. Clinical Site Management and Monitoring

6.1. Ensure the conduct of the trial is in compliance with approved protocol, cGCP, cGCLP, and all applicable regulatory and local requirements.

6.2. Organize and provide all site training (e.g. Investigator Meetings and Site Initiation

Visits as well as ongoing training throughout the study).

6.3. Perform protocol-specific clinical site monitoring, identification, assessments and develop selection plans.

6.4. Clinical Site Visits:

6.4.1. Site qualification visits to evaluate and perform gap analysis for clinical sites to ensure clinical trial is conducted in accordance with Good Clinical Practice (GCP) and all local regulations

6.4.2. Site Initiation Visit, Routine Monitoring Visits, and Site Close out Visits

6.5. Develop and implement a robust risk based monitoring plan with quality metric deliverables on an ongoing basis to evaluate site status

6.6. Ensure clinical sites have documentation of proficiency in: GCP, Investigator

Responsibilities, Protection of Human Subjects

6.7. Ensure site and IRB/EC is in compliance with Federal Wide Assurance (FWA)

6.8. Assist sites with the development of recruitment and retention plans, monitor site recruitment and retention as well as subject visit compliance.

6.9. Initiate enrollment of eligible subjects in accordance with institutional and regulatory guidelines to complete studies.

6.10. Monitor participant enrollment and quality metrics. Establish and maintain centralized monitoring reporting systems to track individual site activities such as numbers of subjects screened, enrolled, withdrawn and completed.

6.11. Develop and implement risk management contingency plans for slow enrollment such as frequent meetings with the clinical sites and identification and pre-qualification of back-up clinical sites.

6.12. Manage investigator site payments, vendor payments, and other indirect/direct costs per contract and budget.

6.13. Utilize a clinical trial management system that includes a robust risk-based monitoring system integrated with central monitoring system tools using real-time data shared by the SDCC.

6.14. Provide ongoing and active vendor management of all subcontractors.

6.15. Review site performance on an ongoing basis and work directly with site staff to improve processes and achieve best practices.

6.16. Develop and implement clinical site quality management programs including data quality assessments, source data validation, and quality audits.

6.17. Develop and implement clinical site quality checks on study personnel performance and on study specific regulatory and SOP documents.

6.18. Develop and maintain a system to monitor all clinical site items that require expiration dates such as site personnel professional licensures, IRB initial approval and periodic IRB status reports, Federal Wide Assurance certification, equipment inspections, temperature monitoring or calibration, and laboratory license(s).

6.19. Coordinate biological specimen management with the central laboratory or other designated facilities, and coordinate shipment and storage at the Biological Sample and Investigational Product storage facility (BSIP).

6.20. Coordinate and manage investigational product/device shipment, delivery, proper storage, and inventory at clinical sites. Conduct accountability procedures and coordinate and manage end of study disposition.

6.21. Procure study supplies, manage kitting, shipment, delivery, proper storage, and inventory at clinical sites.

C.3.2. Response Clinical Trial Planning and Execution Task Orders for response clinical trial planning and execution will be for services to prepare for and support activities related to the conduct of clinical trials with unusual but critical expedited timelines. Offerors shall commit to the following in addition to meeting all of the Technical Requirements outlined in Section C.3.1. above:

1. Respond to RTORs by submitting a proposal to BARDA under expedited timelines (for example, within 72 hours during an emergency).

2. Initiate a clinical study under expedited timelines upon Task Order award. The protocols for these studies may be established prior to an emergency, or created at the time of an emergency.

3. Collaborate with BARDA to develop emergency response clinical trial design templates (for example, generic master protocols), provide expertise, compare and contrast potential trial designs and make recommendations, provide a global footprint, and enable rapid independent ethics reviews.

4. Have internal systems and processes in place to protect worker safety and security in austere settings.

C.4. MEETINGS

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

C.5. REPORTING REQUIREMENTS

See SECTION F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Contractor. The first “kick-off” site visit will be convened within 30 calendar days of contract award to review HHS procedures, processes and expectations, as well as Contractor’s data and plans. Qualified subject matter experts will perform program assessment.

C.6. CONTINUITY PLANNING REQUIREMENTS

Provide Continuity of Services Plan to manage activities during a business disruption. Within 30 days of contract, provide emergency contact list to identify time-sensitive or critical business functions and processes and the resources that support them. Offeror may use the Continuity of Services Plan template, Attachment 13, or use the Offeror’s template.

C.7. SECURITY PLAN

The contractor will prepare IT Security Deliverables in accordance with Sections F and H.

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D. PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, 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 supplies/services/documentation shall be delivered in immediate usable and acceptable condition.

E. INSPECTION AND ACCEPTANCE

E.1. FEDERAL ACQUISITION REGULATIONS INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://acquisition.gov/far/

The following FAR clause, pertinent to Section E, is hereby incorporated by reference:

FAR Clause Title Date

52.246-4 Inspection of Services – Fixed Price Aug 1996 52.246-5 Inspection of Services – Cost Reimbursement Apr 1984 52.246-9 Inspection of Research and Development (Short Form) Apr 1984 52.246-16 Responsibility for Supplies Apr 1984

E.2. GOVERNMENT RESPONSIBILITIES FOR INSPECTION AND ACCEPTANCE

All work under this contract may be subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government. The Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for the inspection and acceptance of all items/activities to be delivered and or completed under this contract. Inspection and acceptance will be performed at the destination of the supplies, services or documentation delivered for performance under this contract.

E.3. PERSON-IN-PLANT

The Government reserves the right to be present during the execution of task orders as a person-in-plant.

E.4. AUDITS

The Contractor shall allow for and provide requested information to support security, quality, regulatory, and cGCP and/or cGLP audits conducted by USG on an ad hoc basis. The estimated frequency of audits under this paragraph is annually, unless an audit for cause is determined necessary at the discretion of the Contracting Officer. If the USG finds non-compliances or deficiencies during its audit(s) on firm fixed price line items, the Contractor, at its sole expense, shall take all necessary corrective action within a timely manner. In addition, the Contractor shall provide all information requested by the USG, including the FDA, to facilitate a cGCP and/or cGLP inspection during the conduct of a clinical trial.

http://acquisition.gov/far/

F. DELIVERIES / PERFORMANCE

F.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://acquisition.gov/far/

The following FAR clause, pertinent to Section F, is hereby incorporated by reference:

FAR Clause Title Date

52.242-15 Stop Work Order Aug 1989 52.242-15 Stop Work Order – Alternate I (Apr 1984) Aug 1989

F.2. PERIOD OF PERFORMANCE

The base period of performance (PoP) is anticipated to be two (2) years from date of award, with up to three (3) options periods, as listed in the table of CLINs in Section B. If exercised, the length of each option period shall be one (1) year.

In no event shall the contract’s period of performance exceed five (5) years from original date of award.

The Government is not obligated to exercise option periods under this contract.

F.3. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this contract and upon delivery and acceptance of the items described in SECTION F by the Contracting Officer or their duly authorized representative.

Deliverables will be further defined upon the issuance of specific Task Orders.

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.4.1. Submission of Contract Deliverables Documents shall be delivered electronically via email to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR), listed in Section G.1 and G.2. When electronic deliverables are not preferred by the Contracting Officer, deliverables and reports furnished to the Government under the potential resultant contract (including invoices) shall be addressed as indicated in Section G.3.

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the CO and the COR, technical progress reports as identified in resultant TO. These reports shall be subject to the technical inspection and requests for clarification by the COR and CO, shall be brief and factual, and prepared in accordance with the formats described in the following section.

http://acquisition.gov/far/

F.5. DELIVERABLE SCHEDULE

Deliverable Description Delivery Date

Kickoff Meeting The contractor shall complete a Kickoff meeting after contract award and/or within 30 calendar days 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.

Within 30 calendar days of contract award a Kickoff meeting will be held.

Status Update Meetings

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 quarterly intervals, either in person or via teleconference, to review 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.

Status Update Meetings schedule will be established by the Contracting Officer’s Representative and Contracting Officer after contract award.

Annual Meeting Annual Meetings: The contractor shall arrange and may conduct an annual site visit for BARDA contracting and BARDA program staffs 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 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

Annual Meetings should occur once a year within 30 calendar days of the anniversary of the contract award date.

Program Review Meetings shall occur at least annually during contract period of performance.

Periodic Site Visits Periodic Site Visits will include, if applicable, subcontractor facilities.

Periodic Site Visits will occur on an ad hoc basis.

Security and Quality Systems Audits

Security and Quality Systems Audits/QA audits: The contractor shall take the necessary corrective action in response to audit findings in a timely manner.

Security and Quality Systems Audits/QA audits may be conducted pre-award and on an ad hoc basis. A summary of these audits will be provided within 25 business days to the contractor.

Monthly/Quarterly / Annual, Task Order / Milestone / Final Technical Progress Reports

Monthly/Quarterly/Annual /Task Order/ Milestone Technical Progress Reports shall address each of the below items and be cross-referenced to the WBS. These reports are subject to the technical inspection and requests for clarification by the Contracting Officer’s Representative.

Monthly Technical Progress Reports will include project timelines, milestones and summaries.

Quarterly Technical Progress Reports will include project summaries as well as performance metrics for the prime contractor.

The Technical Reports shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats. Technical Progress reports shall include the following information:

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