RFP_75A50119R00028_BSIP_(9.6.2019).pdf

75A50119R00028

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

1 107

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) local timeuntildepository 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

1200 ET 10/07/2019

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)

6-9 10-19 22-30 31-36 37-60

61-76

78-82

83-98 99-107

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 the 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

INTRODUCTION / BACKGROUND

C.1

C.2. STATEMENT OF OBJECTIVES

C.3. TECHNICAL REQUIREMENTS

C.4. MEETINGS

C.5. REPORTING REQUIREMENTS

C.6. SECURITY PLAN

C.7. CONTINUITY PLANNING REQUIREMENTS

D. PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

E. INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

E.2. AUDITS

E.3. GOVERNMENT FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY

REFERENCE

F. DELIVERIES / PERFORMANCE

F.1. PERIOD OF PERFORMANCE

F.2. DELIVERIES

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.5. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

G. CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER

G.2. CONTRACTING OFFICER’S REPRESENTATIVE

RFP 75A50119R00028

G.3. DELIVERIES

G.4. CONTRACTOR’S POINT OF CONTACT

G.5. ORDERING PROCEDURES

G.6. PAYMENT BY ELECTRONIC FUNDS TRANSFER (Oct 2003)

G.7. INVOICE SUBMISSION

G.8. CONTRACT COMMUNICATIONS / CORRESPONDENCE

G.9. POST-AWARD EVALUATION OF CONTRACT PERFORMANCE

G.10. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

(End of Clause)

G.11. NEGOTIATED INDIRECT RATES AND CEILING

G.12. GOVERNMENT PROPERTY

G.13. HHSAR 352.242-70 KEY PERSONNEL (Jan 2006)

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. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

H.7. NEEDLE DISTRIBUTION

H.8. ACKNOWLEDGEMENT OF FEDERAL FUNDING – PUBLICATION AND PUBLICITY

H.9. RESTRICTION ON ABORTIONS

H.10. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

H.11. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

H.12. OPTION PROVISION

H.13. DESIGNATION OF OMBUDSMAN

H.14. SUBCONTRACTING PROVISIONS

H.15. CONFIDENTIALITY OF INFORMATION

H.16. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

H.17. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

H.18. POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

H.19. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

H.20. ACCESS TO DOCUMENTATION / DATA

H.21. IN-PROCESS REVIEW

H.22. IDENTIFICATION AND DISPOSITION OF DATA

H.23. DISSEMINATION OF INFORMATION

H.24. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR 352.239-73 (December 2015)

H.25. 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 64

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. FAR 52.216-1 CONTRACT TYPE (Apr 1984)

L.2. DELIVERY AND PACKAGING OF PROPOSALS

L.3. MANDATORY CRITERIA

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. MANDATORY QUALIFICATION CRITERIA

M.5. TECHNICAL EVALUATION

RAITINGS FOR TECHNICAL PLAN/APPROACH, ORGANIZATIONAL EXPERIENCE AND COMPETENCY, KEY

PERSONNEL QUALIFICATIONS, AND FACILITIES, EQUIPMENT, AND OTHER RESOURCES

M.6

M.7. PAST PERFORMANCE

M.8. BUSINESS PROPOSAL EVALUATION

M.9. SMALL BUSINESS (SB) SUBCONTRACTING PLAN

M.10. EVALUATION OF OPTIONS

B. SUPPLIES / SERVICE AND PRICE / COST

Medical Countermeasures Clinical Studies Network

B.1. BRIEF DESCRIPTION OF SUPPLIES / SERVICES

This Request for Proposal (RFP) solicits proposals for a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) contract for a Clinical Studies Network (CSN) Biological Specimen and Investigational Product (CSN BSIP) Storage Facility. With this solicitation, the BARDA CSN seeks to acquire centralized storage services with state-of-the-science biological specimen (BP) and investigational product (IP) resource practices that promote specimen and data quality, adhere to legal requirements, and follow published best practices guidelines for the collection, receipt, storage, protection, processing, tracking, retrieval, packaging and shipping of biological specimens and investigational product retained samples, with set-up of a database and maintenance of associated data regarding these specimens. Biological specimens include samples obtained from human subjects (and possibly non-human subjects) or potentially other protocol-mandated specimens, and may include viruses, bacteria or other microorganisms. In addition, legacy samples and associated data currently in temporary storage at contract research organizations (CROs) will also be transferred to the CSN BSIP storage facility as part of the initial activities for this contract.

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 Chemical, Biological, Radiological, and Nuclear (CBRN) threats, Pandemic Influenza (PI), and Emerging Infectious Diseases (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 to secure a space to store specimens in the Biological Specimen and Investigational Product (BSIP) storage facility, 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 Statistical and Data Coordinating Center (SDCC); and

2. RFP No. 75A50119R00026– Seeks offers for the Clinical Trial Planning and Execution (CTPE) services on a routine basis without urgent timelines, as well as services during an emergency when rapid timelines are crucial.

This current solicitation addresses requirements for the BSIP only. Any resultant contract awarded from this requirement will require close coordination with those contract(s) awarded for the SDCC and CTPE services. 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 Biological Specimen and Investigational Product (BSIP) Storage Facility

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 engage a single Offeror to:

1. Provide centralized sample storage with standardized processes including inventory management.

2. Provide long-term storage of biological specimens (possibly non-clinical specimens) and investigational product retained samples across BARDA-supported studies.

3. Manage transport of biological specimens and investigational product retained samples for end-of-study archiving and future use (retrieving, labeling, shipping, tracking, etc.).

4. Transfer legacy biological specimens and investigational product retained samples currently in temporary storage at contract research organizations (CROs), and associated inventory data, to the BSIP as part of the initial activities for this contract.

B.3. CONTRACT TYPE

The Government intends to award a single Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract for the 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 Cost Reimbursement including Cost Plus Fixed Fee (CPFF)

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

The Base Period of Performance (PoP) shall be five 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

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 Request for Task Order Response (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- 0006 Option Years 6-10: Clinical Studies Network Task Orders TBD

* TBD – To Be Determined.

Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete clinical study services

Unless the Government exercises its option pursuant to the option clause referenced in SECTION I, Contract Clauses, this contract consists only of the base period.

B.6. ADVANCED UNDERSTANDINGS

B.6.1. Minimum Order Amount - $1,000 The Contractor shall be reimbursed by the Government a one-time amount not less than a total of $1,000 (regardless of option years exercised).The Government is not obligated to order more than the stated minimum for the entire contract period including option periods.

B.6.2. Maximum Ordering Amount - $250,000,000 The Contractor shall not receive payment from the Government in an amount greater than $250,000,000.00 for successful performance under this contract. This contract ceiling is the Government’s most optimistic scenario with respect to the Government’s needs and level of funding.

B.6.3. Minimum Guarantee - $200,000 The total minimum guarantee under this IDIQ contract is $200,000.00. This one-time amount will be issued at the end of the contract. If no TOs are received during the base contract, this amount can only be claimed at the end of the period of performance of the base contract if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one TO and providing a clear explanation for not submitting a proposal in response to TOs.

Funds for requested services provided will be obligated, at the task order level, as task orders are placed. Excess funds will be de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The Contractor will 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.6.4. 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. Cost Unallowable Unless Authorized by the Contracting Officer

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

4. Accountable Government Property;

5. Overtime

6. Travel to attend general scientific meetings/conferences;

7. Foreign Travel Costs;

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

$250,000.00;

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 listed in Section J, and include an 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 Biological Specimen and Investigational Product (BSIP) Storage Facility

C.1. INTRODUCTION / BACKGROUND

The purpose of this Request for Proposals is to solicit applications for long-term storage of biological specimens (BS) and investigational products (IP) for the Biomedical Advanced Research and Development Authority (BARDA) Clinical Studies Network (CSN). The CSN will provide a robust and readily accessible infrastructure for rapid implementation and high quality performance of clinical trials in a breadth of indications related to development of medical countermeasures (MCMs). In addition to the BS and IP storage facility (BSIP), the CSN will consist of one statistical and data coordinating center (SDCC), and several CROs for clinical trial planning and execution (CTPE) of routine and/or response clinical trials relating to emergencies. 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 initial CSN infrastructure.

C.2. STATEMENT OF OBJECTIVES

BARDA seeks to engage a single facility for long-term storage and inventory management of biological specimens (possibly non-clinical specimens) and investigational product retained samples across BARDA-supported clinical trials. The Offeror will manage transport of biological specimens and investigational product retained samples for end-of-study archiving and future use (retrieving, labeling, shipping, tracking, etc.) and will transfer legacy biological specimens and investigational product retained samples currently in temporary storage at contract research organizations (CROs), and associated inventory data, to the BSIP as part of the initial activities for this contract.

C.3. TECHNICAL REQUIREMENTS

This contract is for the establishment, management, and operation of a well-regulated Biological Specimen and Investigational Product (BSIP) storage facility based on standard operating procedures (SOPs) centered on standards and published best practices. The BSIP must be capable of the receipt, storage, protection, potential aliquoting, retrieval, labeling, packaging, repackaging, shipping, acquiring, testing, and disposition of biological specimens and investigational product retained samples. The aliquoting requirement would mandate facilities consistent with CDC/NIH biosafety guidelines. The contract also includes establishing, validating, maintaining and tracking detailed information on all specimen collection, processing, storage, and distribution in the storage facility’s information and database systems. The database systems must be commercial off-the-shelf systems (COTS), validated– i.e. CFR, ISO 9001, and able to exchange information electronically with other database systems of the CSN Infrastructure. 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. Biological Specimens

C.3.1.1 Receipt and Long-Term Storage of Biological Specimens. Depending on the protocol, specimens may include serum, PBMCs, whole blood, plasma, or blood-spotted on filter paper. Possibilities may include a more extensive list depending on the protocol. A task order may specify granulocytes, serum, DNA\RNA, urine in tube aliquots, saliva in tube aliquots, tissue slides, biopsy specimens, or other surgical specimens.

The Contractor shall receive biological specimens and provide long-term storage of biological specimens in support of clinical (or other) research consistent with the period of performance specified in this contract. The following tasks apply:

1. Develop electronic specimen shipping request forms for external use and sample tracking at BARDA- designated facilities, including clinical sites, central laboratory, or other designated facilities that would ship biological specimens to the BSIP.

2. Obtain all required import and export permits and authorizations for receiving, storing and distributing biological specimens.

3. Upon receipt of a biological specimen shipping request to provide long-term storage of biological specimens, provide instructions for shipping and handling of biological specimens to preserve specimen integrity and utility including labeling, storage and shipping requirements that confirm chain of custody and comply with all applicable domestic and international laws and regulations.

4. Receive shipments of biological specimens from domestic and international BARDA designated sites.

5. Perform and document quality assurance inspection and verification of all incoming and outgoing shipments at the specimen level per best practice guidelines and relevant standards. Identify and reconcile any discrepancies or problems that arise.

6. Develop and implement communication plans consistent with BARDA SOPs.

7. Store biological specimens at temperatures and conditions in validated temperature units indicated by the documentation provided with the specimens from the facility of origin.

8. Monitor and document conditions to ensure that biological specimens are maintained consistently for the duration of storage.

9. Maintain a contingency plan for movement of specimens due to equipment unit failure outside of validated ranges.

C.3.1.2 Capability for Aliquoting and Labeling of Biological Specimens Aliquoting must take place in facilities and with equipment consistent with CDC/NIH biosafety guidelines. The Contractor shall aliquot and label biological specimens received as follows:

1. Provide and maintain the necessary clean room(s) and equipment for the aliquoting and labeling of clinical or other biological specimens.

a. The threshold required would depend on the processing requirements of the task order.

b. Detailed requirements for aliquoting, labeling, etc. will be provided with the Statement of Objectives of each individual task order.

c. Offerors should submit their capabilities for both routine as well as more specialized types of work.

2. Aliquot and label clinical or other biological specimens for distribution in appropriate containers upon request.

C.3.1.3 Shipping, Distribution, and Testing of Biological Specimens The Contractor shall ship biological specimens to test laboratories, or other BARDA-designated facilities, in accordance with good distribution practices as they apply to each type of biological specimen. In general, the best practices for the chain of custody should be applied when shipping biological specimens. The Contractor shall follow comprehensive standard operating procedures (SOPs) that meet industry best practices for each type of biological specimen so that specimen integrity concerns are minimized. The Contractor shall ship biological specimens in compliance with all domestic and non-domestic biological transportation laws and regulations as follows:

1. Provide arrangements for testing of biological specimens upon request of the COR.

This involves establishing appropriate communications with BARDA, the SDCC, and the testing facility, as well as providing reliable service.

2. Package and ship components for safe, intact arrival of biological specimens at the temperature and condition specified.

3. Create forms for verification of shipment receipt. This form shall be enclosed in all biological specimen shipments and shall be returned to the Contractor to confirm receipt and arrival condition of biological specimens at the laboratory.

4. Ship biological specimens to laboratories or sites per protocol according to the timelines specified—generally within 24 hours for domestic and 3-5 calendar days for non-domestic shipments.

5. For international shipments, within 2 days of the request, inform the COR of: a) information that is required from BARDA; and b) the expected timeline for shipment.

C.3.1.4. Tracking and Electronic Inventory Management of Biological Specimens

The Contractor shall track and inventory biological specimens by maintaining a validated commercial-off-the-shelf (COTS) electronic inventory management system to track, code, and archive information on all biological specimens received, stored, and shipped to and from the BSIP. The minimum requirements are as follows:

1. Protocol number

2. Specimen identification number

3. Origination site

4. BARDA program

5. Date of receipt

6. Number of units received/unit of measure

7. Number of aliquoted units provided

8. Total number of units or aliquots remaining

9. Storage location and storage condition within the BSIP

10. Identity and destination of shipping requests

11. Number of units shipped to each destination

12. Perform routine physical inventories of biological specimens.

13. Identify and document any discrepancies. Reconcile with the current computerized inventory

14. The Offeror should have the ability/resources to modify the electronic inventory as necessary and export data to the SDCC and other entities as needed.

15. The Offeror should have the ability/resources to receive data from the SDCC and other entities.

C.3.1.5. Final Disposition of Biological Specimens

Upon request from the COR, remove identified biological specimens from active stock at the BSIP and dispose of them in accordance with domestic and international regulations, as applicable. Provide certificate of destruction to BARDA per SOP.

C.3.2. Investigational Product (IP)

C.3.2.1 Receipt and Storage of Investigational Product (IP) The Contractor shall receive and store IP from CROs and product suppliers as follows:

1. Develop and maintain an electronic IP agent shipping request form to track and inventory IP retained samples shipped to the BSIP storage facility.

2. Upon receipt of an IP shipping request, confirm the regulatory status of the IP.

Provide suppliers with written instructions for appropriate shipping and handling to arrange for regulatory compliant shipments.

3. Obtain all required import/export permits and authorizations for receiving and storing IP.

4. Perform and document inspection of shipments received and resolve any discrepancies or problems that arise. Follow BARDA guidelines in reporting deviations to the COR.

5. Perform product inspection, temperature verification, accountability, and storage. Notify the COR of any deviations or discrepancies per communication plan and contractual agreement, generally within 24 hours.

6. Track and record contents and condition of each shipment. Electronically document chain of custody, shipment receipt date, condition and results of inspection of IP and shipments.

7. Verify the inclusion of product information document (e.g. Certificate of Analysis (CoA)) with each shipment of IP, as applicable. Perform and document a review of each CoA and resolve any discrepancies or problems that arise.

8. Store IP at temperatures and conditions indicated by BARDA. Provide continuous, twenty-four (24) hour temperature condition monitoring surveillance and electronically document storage conditions.

9. Provide a plan for continuity of operations/disaster management in the event of equipment failure or other catastrophic event.

C.3.2.2. Labeling, Packaging, and Repackaging IP

1. The Contractor shall label, package and/or repackage IP for distribution to laboratories or other facilities if needed.

2. Develop an electronic request form for use in review and approval of requests for labeling, packaging and repackaging of IP.

3. Generate appropriate labels for product in compliance with protocol labeling requirements. Affix approved labels to IP.

C.3.2.3. Documents and Regulations for Shipping IP

The Contractor shall obtain and maintain all required permits and authorizations to comply with relevant domestic and non-domestic laws and regulations for shipping stored IP retains to a designated facility as deemed necessary.

C.3.2.4. Shipping Preparation Procedures and Equipment for IP The Contractor shall use appropriate shipping and packaging procedures and equipment as follows:

1. Validate all equipment and SOPs

2. Provide all associated SOPs within ten days for validation and testing of the procedures for the packaging and shipping of IP.

C.3.2.5. Shipping of IP The Contractor shall ship IP to testing laboratories as follows:

1. Prior to processing and shipping a request, verify and document the availability of IP to ship for testing.

2. Request approval by COR

3. Document receipt of necessary regulatory documents as applicable

4. For international shipments, within 2 days of the request, inform the COR of: a) information that is required from BARDA; and b) the expected timeline for shipment.

C.3.2.6. Tracking of Inventory Management of IP

The Contractor shall maintain a validated electronic inventory management system to track, code, and archive information on all IP received, acquired, stored and shipped to and from the BSIP including the following information:

1. Identity of IP

2. Lot number

3. Manufacturer/source of product

4. Source point of contact

5. Shipping Date

6. Quantity shipped

7. Quantity received

8. Storage location

9. Shipping request

10. Site or laboratory

11. Protocol number

12. Expiration and retest dates

Perform routine physical inventories of all IP held at the BSIP. Identify and document any discrepancies that cannot be reconciled with the current computerized inventory.

Monitor all shipment data to capture protocol, lot number, recipient, shipment date and site or laboratory.

C.3.2.7 Final Disposition of IP

Upon request from the COR, remove identified IP samples from active stock at the BSIP and dispose of them in accordance with domestic and international regulations, as applicable. Provide certificate of destruction to BARDA.

C.3.3. Overall Contract Requirements

C.3.3.1. Security, Safety, Monitoring and Maintenance of Facilities and Equipment The Contractor shall provide safe, secure facilities, monitored 24 hours per day, 7 days per week; and equipment for the receipt, storage, quarantine, processing and distribution of biological specimens that are compliant with best practice guidelines and relevant standards. The Contractor shall maintain standard operating hours, except for official U.S. Federal holidays. The Contractor shall establish procedures for emergency closings due to weather conditions or other unexpected closings mandated by local, state and Federal government authorities. The Contractor shall remain open during emergencies upon request to support critical time-sensitive clinical research and government activities. The Contractor will provide BARDA with a plan for continuity of operation procedures.

C.3.3.2. Electronic Information Systems, Data Management, and System Security

Electronic Information System (Inventory Database/Tracking System Management) The Contractor shall maintain and operate an off-the-shelf inventory database management system that captures the following features:

1. Archiving, tracking, and coding all agents and biological specimens and IP retained samples received and stored at the BSIP as well as all shipping requests for specimens and IP.

2. Generation of integrated reports to sort data by various criteria.

3. Electronic Ordering System/Database Management System for tracking biological specimens and IP

a) Provide a semi-annual report on potential system modifications and improvements, and implement COR-approved system modifications and improvements.

Data Management The Contractor shall maintain the capacity and compatibility of the BSIP database systems to access, receive, transmit, upload and download specific data from common platform data management systems. Ensure the effective and efficient coordination of data to complete specified functions in collaboration with BARDA Regulatory Affairs, and the BARDA Statistical and Data Coordinating Center (SDCC) contractor as part of the CSN. Use of a COTS specimen inventory system is intended to facilitate efficient and accurate transfer of data between the BSIP and SDCC as well as other facilities. Data management functions of the BSIP include:

1. Utilization of a COTS software system to barcode, scan, identify and track biological specimens and IP retained samples.

2. Development and implementation of approved validation processes and procedures to ensure the accuracy, completeness and integrity of data in the systems.

C.3.3.3 Training of BSIP Personnel

The Contractor shall provide and mandate training for BSIP personnel in order to perform the activities outlined in this Statement of Objectives as follows:

1. Provide and document completion of training regarding safety measures for handling biological specimens and IP; maintaining cold chain measures;

receipt, storage, and shipping procedures; inventory procedures; labeling procedures; and final disposition of biological specimens and IP.

2. Provide and document completion of annual training for all personnel with access to the BSIP as appropriate for facility security, fire drills, fire suppression system, best practice guidelines and relevant standards, dry ice handling, personal protection and use of personal protection equipment, employee monitoring systems for use in walk-in freezers, and chemical spill clean-up procedures.

3. Provide and document completion of training for BSIP personnel in the proper packing and use of validated shipping containers, on the use of standard forms and templates for letters and memoranda, and record keeping practices.

4. Provide and document completion of training of BSIP personnel in the use of computer systems for databases and software systems required to meet the objectives and functions of the BSIP.

5. Train applicable staff on new SOPs and document by signature to verify that the training has occurred.

6. Establish a regular forum to ensure that BSIP personnel are informed and have the opportunity to:

a) Review new and revised SOPs;

b) Obtain training on new and revised SOPs;

c) Review established SOPs when breaches in procedures have occurred;

identify protocol-specific issues;

d) Be cross-trained for prevention of impeded work flow;

e) Be briefed on current issues; and

f) Identify issues that need to be brought to the attention of the COR.

C.3.3.4 Quality Assurance/Quality Control (QA/QC)

1. The Contractor shall develop and implement a Quality Assurance Program, and

SOPs to standardize processes and ensure that the conduct of all BSIP activities complies with best practice guidelines and relevant standards and meets the requirements of the contract.

2. The Contractor shall develop a quality assurance (QA)/ quality control (QC) monitoring plan that ensures compliance with federal and local regulations.

3. [FOR PROPOSAL PURPOSES ONLY] A draft Quality Assurance/Quality Control (QA/QC) plan shall be provided as an attachment for technical evaluation (L.4.3).

4. Due –Diligence BARDA Routine Audits: A risk-based approach to audits will be taken by BARDA. The Contractor will be qualified through a due diligence audit to perform the requirements of the contract. Thereafter, routine audits will be conducted at least biennially to monitor compliance with best practice guidelines, relevant standards, and contract requirements.

C.3.3.5 Project Management and Administration The Contractor shall:

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

2. Develop and maintain a “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)

3. Develop and maintain comprehensive timelines in MS Project

4. Provide written project status reports according to pre-specified schedules.

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

6. The contractor will provide finalized versions of the Communication Plan and Project Management Plan to BARDA within 30 calendar days of award

C.3.3.6 Final Transition

1. The Contractor shall design and implement an approved Final Transition Plan at least 60 calendar days prior to expiration of the contract. The Final Transition Plan shall provide for the efficient, orderly and safe transition of contract activities, data systems, documents and other information to the successor contractor or to the Government, without loss of time or interruption to the conduct of ongoing BARDA-supported MCM development. The Contractor shall:

a. Maintain full operational capacity until the expiration date of the contract, including implementation of the final transition and all necessary transition and closeout functions.

b. Provide a description of transition activities, timelines, and assigned staff in a Draft Final Transition Plan and Final Transition Plan, which will be reviewed and approved by the COR and Contracting Officer. The Draft Transition Plan shall be submitted at least 180 calendar days prior to the expiration date of the contract, and the Final Transition Plan (approved by the COR and Contracting Officer) shall be submitted at least 60 calendar days prior to the expiration date of the contract.

c. Arrange to have the specimens moved to another vendor at the end of the contract or upon termination.

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.

1. The Contractor shall participate in the following:

a. Contract Initiation Meetings and kick-off

b. CSN Progress Meetings or Teleconferences

c. Annual Meetings

d. Ad Hoc Meetings and Teleconferences

e. Site Visits and BARDA Audits

The contractor shall make all arrangements for BARDA site inspections and independent audits of Contractor facilities and facilities of any subcontractor as needed or requested by the COR in order to evaluate compliance with domestic and non-domestic laws and regulations, FDA regulations and guidance documents, BARDA policies, and the terms of the contract.

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 CO/COR 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.

Updates for biological specimen and investigational product storage data will be provided to BARDA in routine reports as well as upon request. The frequency, format, and content will be negotiated at the time of award and finalized at the project kick-off.

C.6. SECURITY PLAN

The Contractor’s Security Plan will be included as an attachment to any contract awarded under this solicitation upon approval by the Contracting Officer. See Attachment 12.

C.7. CONTINUITY PLANNING REQUIREMENTS

The contractor shall provide a Continuity Plan to manage sample storage during a business disruption.

Within 30 calendar days of contract, provide emergency contact list to identify time-sensitive or critical business functions and processes and the resources that support them. See Attachment 13.

[The Remainder of the Page Left Intentionally Blank]

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.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

E. INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

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

B. For the purpose of this section, (to be filled-in at award), is the authorized representative of the Contracting Officer.

C. Inspection and acceptance will be performed at the destination of the articles, services or documentation delivered for the performance of this contract.

D. The USG hold the right to be present during the execution of the tasks as a man-in-plant.

E.2. AUDITS

The Contractor shall allow for and provide requested information to support security, quality, regulatory, and best practice audits conducted by USG on an ad hoc basis. The estimated frequency of audits under this paragraph is biennially, 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.

E.3. GOVERNMENT FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY

REFERENCE

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

FAR 52.246-2, Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-3, Inspection of Supplies – Cost-Reimbursement (May 2001)

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

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

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

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

F. DELIVERIES / PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance under this contract is anticipated to be five (5) years from date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, as set forth in SECTION B.

In no event shall the period of performance exceed ten (10) years under this contract.

F.2. 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.3. by the Contracting Officer or their duly authorized representative.

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

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables Documents should be delivered electronically to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

UPS/FedEx USPS Mail Packages

TBD - Contracting Officer

HHS/ASPR/BARDA

Contracts, Management and Acquisition (DCMA) Tip O’Neil House Office Building Washington, DC 20201

Email: TBD

TBD - Contracting Officer

HHS/ASPR/BARDA

Contracts, Management and Acquisition (DCMA) Tip O’Neil House Office Building

Washington, DC 20201

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

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

Deliverable Description Due Date Kickoff Meeting

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

Within a month of contract award a Kickoff meeting will be held. Program Review Meetings shall occur at least annually during contract period of performance.

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 visits for BARDA CONTRACTING contract 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

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

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

Periodic Site Visits

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

Periodic Site Visits will occur on an adhoc basis.

Security and Quality Systems Audits

Security and Quality Systems Audits/QA audits The contractor shall take the necessary corrective action within 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.

Quarterly/Ann ual, Task Order/Milesto ne / Final Technical Progress Reports

Quarterly/Annual /Task Order/ Milestone…