RFP 75N95022R00013.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health National Institute on Drug Abuse Bethesda, Maryland 20892

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95022R00013

PROJECT TITLE: Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

ISSUED BY:

Evan C. Feely Contract Specialist NINDS Section Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: evan.feely@nih.gov Phone: (301) 827-5301

Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447

DATE ISSUED: January 25, 2022

PROPOSAL DUE: March 07, 2022 at 5:00 P.M. (Eastern Time)

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of RFP No. 75N95022R00013 – NINDS Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders.

This Request for Proposal is released under FULL AND OPEN Competition Procedures.

NINDS prepared this Request for Proposal (RFP) in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, and III of the Uniform Contract Format.

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible mailto:evan.feely@nih.gov mailto:nancy.lamon-kritikos@nih.gov http://www.sam.gov/ http://www.sam.gov/ to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

NINDS anticipates that multiple-award (MAC) indefinite-delivery, indefinite-quantity (IDIQ) contracts with cost reimbursement or fixed price type task orders, will be awarded.

NINDS anticipates these MACS will have an eight-year ordering period that commences on the date of award or shortly thereafter. All contracts will contain a guaranteed minimum of $1,000 and a maximum value of $149,200,000 for the ordering period.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III, which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Offeror Questions Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist and Contracting Officer. Offeror questions must be submitted on or before 5:00 P.M. Eastern Time on February 14, 2022. Offeror questions must be submitted by e-mail to evan.feely@nih.gov and nancy.lamon-kritikos@nih.gov with the subject line:

“RFI – RFP 75N95022R00013”

NOTE: Site visits may be requested.

The Technical Proposal It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed. NINDS will use this information to ensure that no conflicts of interest exist with the selected review committee members. Technical Proposal Instructions are detailed in Section L.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal, which must contain a detailed breakdown of costs for all sample task orders included in the Business Proposal Budget Template. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. Please submit business proposals mailto:evan.feely@nih.gov mailto:nancy.lamon-kritikos@nih.gov with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 7) must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Small Business Subcontracting Plan, Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and received no later than March 07, 2022 at 5:00 P.M., Eastern Time.

Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly.

Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 1.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov).

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The RFP shall take precedence if any of the content in this letter is contradictory.

https://ecps.nih.gov/ https://ecps.nih.gov/howtosubmit https://www.sam.gov/

The NINDS appreciates your interest in this RFP and looks forward to receipt of your proposal.

Requests for any information concerning this RFP should be directed to the undersigned or Evan Feely at evan.feely@nih.gov. Discussions with any other individuals should not occur.

Sincerely, Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892

Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447 mailto:evan.feely@nih.gov mailto:nancy.lamon-kritikos@nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 42 U.S.C. 285 j

2. Request for Proposal (RFP) Number:

75N95022R00013

3. Issue Date:

01/25/2022

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neur

6. ISSUED BY:

National Institute of Neurological Disorders and Stroke (NINDS) Section Office of Acquisitions, NIDA National Institutes of Health c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

7. SUBMIT OFFERS TO: Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https:// ecps.nih.gov. See Part III, Section J, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," Attachment 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE-Attachment 1 "Packaging and Delivery of the Proposal for Use with the NIH electronic Contract Proposal Submission (eCPS) Website" must be received by 05:00 P.M., Eastern Time on 03/07/2022. 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 to be submitted via the electronic Contract Proposal (eCPS) website at https://ecps.nih.gov as stated in ATTACHMENT 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." Proposals submitted by facsimile or e-mail will not be accepted.

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 subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration.

11. FOR INFORMATION CALL: Evan Feely, Contract Specialist

PHONE: 301-827-5301

e-MAIL: evan.feely@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be submitted via email to evan.feely@nih.gov on or before 5:00 P.M., EST, Nancy Lamon-Kritikos https://ecps.nih.gov https://ecps.nih.gov https://www.sam.gov

- 2 -on 02/14/2022. All such emails must contain the subject line: "RFI - RFP 75N95022R00013."

Contracting Officer, NINDS Section NIDA Office of Acquisitions, NIDA National Institutes of Health

RFP Number : 75N95022R00013

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

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. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

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. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

16. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

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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, IF NECESSARY, 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 National Institute on Neurological Disorders and Stroke (NINDS) has a need for manufacturing and nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for National Institutes of Health (NIH) drug discovery and development programs. To that end, several NIH programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract as contemplated by FAR 16.504.

The Contractor shall be reimbursed by the Government in an amount not less than $1,000 (minimum) nor more than a total of $149,200,000 (maximum) for successful performance of this contract.

b. The $149,200,000 is the maximum combined amount for all contract holders under the program for Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders.

c. This IDIQ contract has a total ordering period of eight years. As necessary, NINDS will issue Task Orders for the Contractor to perform any or all of the Performance Activities listed in the Statement of Work (SOW).

d. The NINDS intends to issue Task Order #001 concurrent with this award. This task order award will obligate an amount not less than the negotiated firm-fixed-price for a contract kick-off meeting and will satisfy the contract minimum.

e. The costs set forth in this ARTICLE will cover the contract’s total ordering period.

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

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

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ARTICLE B.3. 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.4. 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.

a. Personal Services and Inherently Government Functions

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

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract.

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

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

b. Site Visits

The NINDS anticipates making visits to the Contractor facility, as needed. Contractor shall be responsible for making the facility available for a visit and arranging meetings with appropriate personnel.

c. Ramp-On Procedures

The Government may periodically review the total number of contractors participating under the IDIQ to ensure that adequate capacity and competition exists for task orders throughout the IDIQ period of performance. Over time, the total number of participating contractors may fluctuate due to various reasons, including a contractor’s ability to perform, industry consolidation, significant changes in program direction and/or priorities, technology advances in drug development processes or procedures, general economic conditions, or other reasons.

If it is determined to be in the best interest of the Government to re-open the IDIQ to new contractors, the Government will announce an open season and solicit new offers by issuing a Request for Proposals (RFP) at any time during the IDIQ period of performance. This re-opening procedure is referred to as “Ramp-On.”

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Any Ramp-On decision will be advertised via a Request for Proposals (RFP) availability notice that will be published on SAM.gov. The RFP availability notice will provide an estimate of the RFP release and closing dates and the number of new awards that the Government intends to make. The Ramp-On solicitation and the review and award selection process will be subject to all applicable federal procurement laws and regulations. Any offeror meeting the eligibility requirements as may be identified in the RFP may submit a proposal.

Any resultant contract award will not extend beyond the period of performance remaining under the IDIQ nor exceed the maximum order total as currently established. In addition, any new contractor will be eligible to compete for future task orders with the same rights and obligations of any of the other existing contractors under the IDIQ.

d. Human Materials

Any acquisition and/or supply of human specimen materials, requires advance written approval from the Contracting Officer.

e. The following research is not anticipated to take place under this contract:

Human fetal tissue;

Human Stem Cell Research;

Recombinant or Synthetic Nucleic Acid Molecules

Large-scale Human or Non-Human Genomic Data

HeLa Cell Whole Genome Sequence Data

Agent or Toxin that is Listed in the U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC)

Highly Pathogenic Agent

f. Manuscripts and press releases

Manuscripts for scientific publications and press releases shall be considered to include the public release of information to any medium. The Contractor shall not submit a final manuscript or publish a press release related to this contract without receiving prior concurrence from the Contracting Officer’s Representative (COR). The Contractor shall submit an advance copy of the document to the Contracting Officer and COR. Upon acknowledgment of receipt, the COR will have ten (10) working days to respond with concurrence or comments. In the event that the COR does not communicate concurrence or comments to the Contractor within ten (10) working days following acknowledgement of receipt of the advance copy, concurrence may be presumed.

g. Informed Consents

All informed consents related to human research materials shall be approved in writing and in advance by the COR.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

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 01/25/2022, 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. The Contractor shall destroy any Personally Identifiable Information (PII) after processing it and retain sanitized records under schedule DAA-0443-2012-0007-0003 for a period of 7 years afterwards.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

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

a. Technical Progress Reports

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.]

For proposal preparation purposes only, it is estimated that electronic version(s) of these reports will be required as follows:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract / task order [ ] Final - Upon final completion of the contract / task order (with a requirement for a Draft Final Report)

Comprehensive Project Plan

When tasked to work on a project via a TO, Contractors shall work with the COR, CO, and other stakeholders identified by the COR to deliver a comprehensive project plan, including work breakdown structures, timelines, key milestones and deliverables, Go/No-Go decision points, resource allocation, budget, intellectual property terms, and a risk mitigation plan.

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

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Standard Operating Procedures

Contractors shall, upon request by the COR, submit any SOPs, method descriptions, and references to be used in the implementation of the studies. Contractor SOPs will be treated as confidential, and how much detail is revealed and at what time can be discussed.

Preliminary Data Reports

After completion of the in-life portion of the study, the Contractor shall prepare a preliminary data report, to be submitted within 5 calendar days from the end of in-life portion of the study. Within 10 calendar days of submission of the data report, the Contractor shall submit a full draft report for review and comment by the COR. After receipt of COR comments, raw data and a final study report shall be delivered and /or transferred to a specified NINDS database.

Final Data Reports

The Contractor in coordination with the NINDS data management representative shall coordinate a seamless transfer of raw and analyzed data, statistical and method(s) of analysis into the NINDS database within 1 week of finalization on study reports.

Comprehensive Summary Reports

As directed by the NINDS COR, a comprehensive report of all studies completed through this contract shall be completed within 45 days after final test results are submitted for each Investigational Agent. Other less comprehensive summaries for “pilot studies and special projects” shall have a 30-day completion requirement for each separate candidate selected.

Quarterly Progress Reports

Quarterly Progress Reports for all testing summaries shall be provided in an approved electronic format to the COR.

Quarterly Reports shall comprise a) a summary of all testing performed in the performance period; b) the status of all projects under development (i.e. new model development, pilot studies), problem areas and any performance delays encountered or that may impede future performance; c) a list of comprehensive summary reports in preparation or completed during the reporting period and d) Solutions to identified problems encountered during the reporting period if any. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. Reports shall be due on or before the 10th calendar day following each reporting period. The Contractor shall send two copies of the Quarterly Progress Reports, one to the COR and one copy to the CO.

Conference Call Summaries

The Contractor shall be required to generate and deliver summaries of all conference calls conducted in performance of work under the contract. The summary shall consist of a bulleted list of decisions made and action items identified on the call. These summaries shall be sent via e-mail to all participants within 48 hours of each call. The exact number and timing for such calls will depend on the specifics and circumstances surrounding each individual project.

Final Progress Report/ Summary of Salient Results

Upon final completion of the contract/TO, the Contractor shall deliver a comprehensive final report to the CO and COR that briefly summarizes all the projects initiated over the course of the contract and their outcomes. This final report should also summarize lessons learned that may be applicable to future NIH Biologics drug development programs. The Contractor will also be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

Manufacturing Reports

1. Minutes of project team meetings held during the month, due by the 15th of the following month

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2. Monthly (or biweekly as necessary) Periodic Project Status Reports, due before each Project Team Meeting

3. Development reports for each process development phase, due after completion of each phase

4. Study reports for each analytical method development, due after completion of each method development

5. Study protocols and study reports for each analytical method qualification. Reports due after completion of each method qualification

6. Executed batch records for manufacturing campaigns

7. Certificates of Analyses. Due at the delivery of each preclinical, engineering and cGMP batch

8. CMC reports. Due after delivery of GLP and/or cGMP batch for each product.

9. Stability study protocols and stability study reports. Study Protocols are due before the start of stability studies.

Stability study reports are due after each sample pull

Nonclinical Reports

1. Minutes of project team meetings held during the month due by the 15th of the following month

2. Monthly (or biweekly as necessary) Periodic Project Status Reports, due before each Project Team Meetinh

3. Study protocols and study reports. Study protocols are due before study initiation and study reports are due after completion of each study

b. 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.

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

2. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR) 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 http://www.esrs.gov

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Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer / Contract Specialist shall be included as a contact for notification purposes at the following e-mail addresses:

Contracting Officer e-mail: [To be specified prior to award]e I.6. of the contract).

3. Invention Reporting

In accordance with contract Article C.3. "Invention Reporting Requirement", an Annual Invention Utilization Report shall be due on or before the anniversary date of the contract award and a Final Invention Statement will be due on or before the expiration date of the contract. Note: The same form is used for both the annual and the final report.

4. Service Contract Annual Report

In accordance with FAR 52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts.", contained in full text in Article I.4. of the contract, the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2), the following information to http://www.sam.gov, with an electronic copy to the Contracting Officer:

1) Contract number and order number.

2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

4) Data reported by subcontractors [if applicable] under paragraph (f) of the subject clause (see full text of clause FAR 52.204-15, “Service Contract Reporting Requirements for Indefinite-Delivery Contracts” at https://www.acquisition.gov/).

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three

(3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

B. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

http://www.sam.gov https://www.acquisition.gov/

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● System Security Plan (SSP) - due within 30 days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract.

The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

● Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

● Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

● POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued.

Thereafter, the POA&M shall be updated at least quarterly.

C. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

● E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

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Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

D. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[X] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

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g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

E. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology.

HHS EA requirements may be located here: https://ocio.nih.gov/PM/Pages/EPLC.aspx.

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

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

4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within fifteen days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/PM/Pages/EPLC.aspx

- 15 -https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

G. Vulnerability Scanning Reports The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period.