NHLBI-ECB-HB-2016-09-JB.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Health Service Act (42 USC 301)

2. Request for Proposal (RFP) Number:

NHLBI-ECB-HB-2016-09-JB

3. Issue Date:

April 30, 2015

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Production Assistance for Cellular Therapies (PACT) - Cell Processing Facilities

6. ISSUED BY:

Office of Acquisitions National Heart, Lung, and Blood Institute National Institutes of Health Rockledge II, Room 6016 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposals," until 3:00 PM local time on June 17, 2015. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSALS." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF

ACQUISITIONS.

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

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: Jeffrey Williams

PHONE: 301-435-0335

e-MAIL: NHLBIExtramuralContractsBranch@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Forward all technical and business questions to Jeffrey Williams at NHLBIExtramuralContractsBranch@mail.nih.gov. All questions must be received via email by 3:00 PM local time on June 4, 2015.

Questions sumitted after this date and time will not be answered.

Jeffrey Williams Contracting Officer Office of Acquisitions National Heart, Lung, and Blood Institute http://www.sam.gov

RFP Number : NHLBI-ECB-HB-2016-09-JB

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE C - STATEMENT OF WORK

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. PRE-AWARD SITE VISITS

f. ESTIMATE OF EFFORT

g. COMMITMENT OF PUBLIC FUNDS

h. PROMOTING EFFICIENT SPENDING

i. COMMUNICATIONS PRIOR TO CONTRACT AWARD

j. RELEASE OF INFORMATION

k. REFERENCE MATERIALS

l. PREPARATION COSTS

m. SERVICE OF PROTEST

n. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Uniform Resource Locators (URLs) in Contract Proposals

6. Page and Formatting Limitations

- 3 -

7. Alternate Proposals

8. Evaluation of Proposals

9. Potential Award Without Discussions

10. Use of the Metric System of Measurement

11. Standards for Privacy of Individually Identifiable Health Information

12. Privacy Act - Treatment of Proposal Information

13. Selection of Offerors

14. Institutional Responsibility Regarding Investigator Conflicts of Interest

15. ROTC Access and Federal Military Recruiting on Campus

16. Certification of Filing and Payment of Taxes

17. Past Performance Information

18. Information and Physical Access Security

19. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Technical Evaluation

3. Human Subjects

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Human Fetal Tissue

Human Embryonic Germ Cell (HEGC) Research

Human Embryonic Stem Cell (HESC) Research

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

7. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Salary Rate Limitation

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

- 4 -

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. LIVE VERTEBRATE ANIMALS EVALUATION

5. MANDATORY QUALIFICATION CRITERIA

6. EVALUATION OF OPTIONS

7. EVALUATION OF DATA SHARING PLAN

8. GEOGRAPHIC DIVERSITY

9. TECHNICAL EVALUATION FACTORS

10. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

11. PAST PERFORMANCE FACTOR

- 5 -

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective of this program is to continue to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, biologic systems, and targeted treatments for serious diseases without effective therapies. This program will fund up to eight (8) geographically dispersed Cell Processing Facilities (CPFs) and one

(1) Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study, administrative, and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung, and blood cellular therapy research. The PACT CPFs shall serve investigators within the scientific community as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. PACT CPFs shall manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. The cellular products manufactured by the CPFs are intended for non-clinical use within the United States.

ARTICLE B.2. PRICES/COSTS

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

ARTICLE B.3. ESTIMATED COST

The estimated cost of this contract is $ .

ARTICLE B.4. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $500 (minimum) nor more than a total of $45,630,651 (maximum) for successful performance of this contract.

b. The prices and costs set forth in this ARTICLE will cover the contract period July 1, 2016 through June 30, 2022.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract.

- 6 -d.

CLIN Task Area Description Type

1 One Administrative and Regulatory Support- Base July 1, 2016 through June 30, 2017 (twelve [12] months)

Fixed Price

2 One Administrative and Regulatory Support -Option One (1) July 1, 2017 through June 30, 2018 (twelve [12] months)

Fixed Price

3 One Administrative and Regulatory Support- Option Two (2) July 1, 2018 through June 30, 2019 (twelve [12] months)

Fixed Price

4 One Administrative and Regulatory Support - Option Three (3) July 1, 2019 through June 30 2020 (twelve [12] months)

Fixed Price

5 One Administrative and Regulatory Support - Option Four (4) July 1, 2020 through June 30, 2021 (twelve [12] months)

Fixed Price

6 to various Two Various *TBN Cell Manufacturing and Process Development Services- January 1, 2017 through June 30, 2021 (fifty-four [54] months)

Cost Reimbursement

**TBD Three Program Closeout and Transition- March 1, 2021 through June 30, 2021 (four [4] months)

Cost Reimbursement

* TBN- To Be Negotiated **TBD- To Be Determined

e. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.5. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this Task Order consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this Task Order.

b. Pursuant to FAR Clause 52.217-9 set forth in ARTICLE H. OPTION PROVISION CLAUSE of this Task Order, the Government may, by unilateral Task Order modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this Task Order. If the Government exercises these option(s), notice must be given before the expiration date of the Task Order.

- 7 -

Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this Task Order. The fixed price of this Task Order will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the Option Services described in SECTION C of the Task Order and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:

Option Period Description of Option Service(s)

Unit Price Total Price of Option

One (1) Administrative and Regulatory Support- Base July 1, 2017 through June 30, 2018 (twelve [12] months)

*TBN ( minimum) TBN (minimum)

Two (2) Administrative and Regulatory Support - Option One (1) July 1, 2018 through June 30, 2019 (twelve [12] months)

TBN TBN

Three (3) Administrative and Regulatory Support - Option Two (2) July 1, 2019 through June 30, 2020 (twelve [12] months)

TBN TBN

Four (4) Administrative and Regulatory Support - Option Two (2) July 1, 2020 through June 30, 2021 (twelve [12] months)

TBN TBN

*Note: To Be Negotiated

ARTICLE B.6. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.7. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

- 8 -

ARTICLE C - STATEMENT OF WORK

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated April 16, 2015, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

i. Bi-Annual Technical Progress Reports - A draft template shall be provided within one month of contract initiation and a progress report shall be due bi-annually thereafter. The major purpose of this report is to supply information regarding methods used to insure that study requirements are being met in an accurate and timely fashion. The report will also include, but is not limited to the following information:

• An update on the progress for all CPF activities related to the task area;

• Any challenges, unresolved issues, and a plan to accomplish their resolution;

• Goals met or missed;

• Summary of activities planned for next period.

ii. Final Technical Progress Report - The Contractor shall submit a final report that documents and summarizes the results obtained during the period of performance.

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

- 9 -

iii. Quarterly Technical Progress Reports - The Contractor shall submit a quarterly technical progress report that summarizes the activities in progress and completed for the period of performance. At minimum, such reports shall include the following specific information.

• Face page to include contract number and title, task order number and title, period of performance being reported, Contractors name and address, telephone and facsimile numbers, and date of submission.

• An executive summary, to include:

• A statement of intended work for the reporting period;

• A brief overview of the work that was completed for the reporting period;

• A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution status;

• An updated summary of timeline and milestones;

• The advancements made in relation to any of the technical tasks set forth in the Task Order Statement of Work;

• A full description of data (including work performed, materials/methods used, problems/resolutions, and accomplishments/goals).

• Any additional information pertinent to the Task Order performance.

iv. Site Visit Outline - A draft outline for a site visit to a requesting investigator laboratory for the purpose of troubleshooting or protocol development. The outline shall be reviewed and finalized by the NHLBI CORs prior to the site visit.

v. Site Visit Report -Contractor shall submit a summary of the work completed during the visit and a list of any unresolved issues.

vi. Task Order Close-out Plan - A close-out plan shall be provided for task closure. The plan shall provide for delivery of appropriate Contract materials, data, databases, files, documents, working papers, original copies of slides and graphics, and for the continuation of on-going work assignments.

Specifically, the plan shall address, but not be limited to:

• Delivery of final work product(s) to the requesting investigator

• Disposition of developed biologics and cellular materials and Government owned equipment

vii. Contract Close-out Plan - The Contractor shall submit a Close-out plan to (1) furnish phase-in, phase-out services and (2) be negotiated in good faith with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities of the work described in the plan, and shall be subject to the Contracting Officer's approval. The plan shall address the completion of all outstanding contract obligations, the delivery of appropriate technical reports, data, databases, files, documents, working papers, original copies of slides and graphics, and for the continuation of on-going work. Specifically, the plan shall address, but not be limited to:

• Ensuring that any manuals, databases and directories developed under the current contract are accurate and current, and provision is made for the orderly transfer of these materials to a new Contractor or the NHLBI, together with complete documentation needed to understand their content, operation and maintenance.

• Ensuring that any biologics, cell banks or other cellular materials developed under the current contract are inventoried, and provision is made for the orderly transfer of these materials to the requesting Investigator, a new Contractor, or the NHLBI, together with complete documentation needed to understand their content, storage requirements and any associated ethical, and legal restrictions .

• The transfer of all reprints, abstracts and other documents, results of searches, databases, and necessary files developed or acquired under the current contract to the new Contractor or the NHLBI.

- 10 -

• The transfer of all laboratory equipment, computer hardware, software and other government property, including computer books or documents purchased or acquired under the current contract, and imparts the knowledge of its functions to the new Contractor or the

NHLBI.

viii. Abstracts and Manuscripts - All abstracts, manuscripts, preprints, and publications that resulted from work conducted or any protocols or methods developed specifically during the period of performance.

ix. Summary of Salient Results - The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the period of performance.

b. Technical Progress Reports Containing Interim Study Data

1. Legend for Technical Progress Reports Containing Interim Study Data

It is recommended that the Contractor incorporate the following legend on the cover of technical progress reports and reports containing study data that are prepared for use by all working committees in their monitoring of the trial. Working committees include but are not limited to the Data and Safety Monitoring Board (DSMB), Steering Committee and Executive Committee.

"The data, if any, contained in this report/deliverable are preliminary and may contain unvalidated findings.

These data are not intended for public use. Public use of these data could create erroneous conclusions which, if acted upon, could threaten public health or safety."

2. Use of Interim Study Data

Interim data used in technical progress reports and other reports developed for the purpose of study monitoring are not intended for public use. Premature release of such data could result in interpretations that prove to be unreliable or invalid once the study is completed and the full context for the data is known.

Unreliable or invalid interpretations can threaten public health and safety by leading the public and medical practitioners to pursue inappropriate measures. In addition, an interpretation of the interim data that is contrary to study protocol could cause participants to drop out of treatment groups. This could prevent completion of the study. A secondary consequence, not in terms of public health and safety, but one that is important in its own right, is that premature release of the data can lead to financial loss to the Government, since any funds spent on a trial that does not answer the questions posed by the study would be devalued.

In consideration of the above, interim data shall be used only for internal study monitoring purposes with the exception of publications and presentations approved in accordance with the programmatic protocol and study procedures.

c. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

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

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

- 11 -

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

2. Information Security and Physical Access Reporting Requirements

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

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

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

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

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

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty

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

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

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

- 12 -

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

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

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

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

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

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

f. Reporting of New and Departing Employees

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

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

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

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

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

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

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

- 13 -

3. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Heart, Lung and Blood Institute Office of Acquisitions 6701 Rockledge Drive, MSC 7902 Rockledge II, Room 6016 Bethesda, Maryland 20892- 7902

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

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

SECTION D - PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. PACKAGING

Packaging procedures shall meet standards for biologically hazardous materials (see the current publication prepared by the International Air Transport Association (IATA), Dangerous Goods Regulations at http://www.iata.org/ publications/dgr/Pages/index.aspx).

ARTICLE D.2. MARKING

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.

ARTICLE D.3. SHIPPING

Shipment procedures shall meet standards for biologically hazardous materials (see the current publication prepared by the International Air Transport Association (IATA), Dangerous Goods Regulations at http://www.iata.org/ http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.iedison.gov

- 14 -publications/dgr/Pages/index.aspx). Shipments shall be tracked and receipt and condition of the biological materials shall be verified.

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Heart, Lung and Blood Institute 6701 Rockledge Drive, MSC 7902 Rockledge II, Room 6016 Bethesda, MD 20892-7901

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

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

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

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is applicable to this contract.

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 07/01/2016 through 06/30/2022.

ARTICLE F.2. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from July 1, 2016 through June 30, 2021.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period One (1) July 1, 2017 through June 30, 2018

Two (2) July 1, 2018 through June 30, 2019 Three (3) July 1, 2019 through June 30, 2020 Four (4) July 1, 2020 through June 30, 2021

Note: For Task Area One, Task Order 00001 only.

- 15 -

ARTICLE F.3. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item Task Area Deliverable Recipient Delivery Schedule 1 1 Bi-Annual Technical Progress

Reports Contracting Officer's Representative (COR), Coordinating Center (CC), and Contracting Officer

(CO)

Draft within 30 calendar days of Task Order award.

Finalize with Project Officer; Submit bi-annually thereafter, Bi-annual report not required when final report is due.

2 1 & 2 Final Technical Progress Report

COR, CC, and CO On or before Task Order expiration.

3 2 Quarterly Technical Progress Reports

COR , CC, and CO Within 15 calendar days following each reporting period.

4 2 Site Visit Outline COR and CO Draft within 10 business days of request, finalize prior to site visit.

5 2 Site Visit Report COR and CO Within 30 calendar days of site visit completion.

6 2 Task Order Close-Out Plan COR and CO Draft due 60 days prior to Task Order expiration, finalize 30 calendar days prior to Task Order expiration.

7 1 Contract Close-out Plan COR and CO Draft due 90 days prior to Contract expiration, finalize 60 calendar days prior to Contract expiration.

8 1 & 2 Abstracts and Manuscripts COR and CC TBD 9 1 & 2 Summary of Salient Results COR, CC, and CO On or before each Task Order expiration.

10 1 & 2 Invention Reports COR and CO In accordance with Article C.3

11 1 & 2 Information Security Physical Reporting

COR and CO In accordance with Articles C.2.c.2 and H.23

- 16 -

Item Task Area Deliverable Recipient Delivery Schedule 12 1&2 Section 508 Annual Report CO In accordance with

Articles C.2.c.3 and H.24

13 1 Federal Conflict of Interest Report (FCOI)

CO In accordance with Articles C.2.c.1 and H.25

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No. Quantity Contracting Officer

National Institutes of Health

National Heart, Lung, and Blood Institute

Office of Acquisitions, DERA

6701 Rockledge Drive

Room 6125A

Bethesda, MD 20892-7902

Email: TBD

(1) (2) (3) (4) (5) (6) (7) (9) (10)

(11) (12) (13)

1 Electronic Copy of Each

Contracting Officer's Representative

(COR)

Email: TBD

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

1 Electronic Copy of Each

Coordinating Center (CC)

Email: TBD

(1) (2) (3) (8) (9) 1 Electronic Copy of Each

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is not applicable to this contract. (For fixed price Task Orders)

Alternate I (April 1984) is applicable to this contract. (For cost reimbursement Task Orders)

52.242-17, Government Delay of Work (April 1984).

https://www.acquisition.gov/?q=browsefar

- 17 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

To be specified prior to award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed

- 18 -

Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

b. Requesting Task Order Proposals.

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

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

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

c. Competitive Ordering Process.

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

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

Generally, the Contractor will be asked to demonstrate the following as appropriate:

• Understanding of the requirements;

• Experience and capability on similar tasks;

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

- 19 -

• Procedures for assuring quality of work, products, and deliverables;

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

• Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

• References to evaluate past performance; and

• Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

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

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

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,000 unless the following exception(s) apply:

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

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

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

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

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

i. For orders exceeding $3,000 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

ii. For orders exceeding the simplified acquisition threshold up to $5 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $5 Million, in accordance with FAR 16.505(b)(1)(iv).

ARTICLE G.4. INVOICE SUBMISSION

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)4 for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

- 20 -

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Heart, Lung and Blood Institute 6701 Rockledge Drive Room 6016 Rockledge II MSC 7902 Bethesda, MD 20892- 7902

Email: nhlbi_branchcinvoice@nhlbi.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

Central point of Distribution: nhlbi_branchcinvoice@nhlbi.nih.gov

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Heart, Lung and Blood Institute .

b. Federal Taxpayer Identification Number (TIN).