RFP_No._NIH-NINDS-16-01.pdf

RFP NIH-NINDS 16-01

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

NIH-NINDS-16-01

3. Issue Date:

March 21, 2016

4. Set Aside:

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

5. Title : Pharmacology and Toxicology for Therapeutics Program (PTTP)

6. ISSUED BY:

National Institute of Neurological Disorders and Stroke

R&D Contracts Management Branch, Office of Acquisitions, NIDA National Institutes of Health Neuroscience Center 6001 Executive Blvd., Suite 3287 Rockville, MD 20852

7. SUBMIT OFFERS TO:

See Part III, SECTION J, "Packaging and Delivery of Proposals," ATTACHMENT No. 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 No.1, "Packaging and Delivery of Proposals," until 4:30 p.m. local time on MONDAY, MAY 9, 2016. Offers will be valid for 120 days unless a different period is specified by the offeror on the ATTACHMENT No. 7 entitled, "Proposal Summary and Data Record, NIH-2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT No. 1, "PACKAGING AND DELIVERY OF PROPOSALS. The OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for in ATTACHMENT No. 1.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR

HIS/HER DESIGNEE AT THE PLACE AND BY THE TIME AND DATE SPECIFIED IN

ATTACHMENT No. 1, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN

ACCORDANCE WITH HHSAR CLAUSE 352.215-70, ENTITLED “LATE PROPOSALS

AND REVISIONS”, LOCATED IN SECTION L.1, PARAGRAPH (k) OF THIS

SOLICITATION.

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

11. FOR INFORMATION CALL: Donna Morris, Contract Specialist

PHONE: 301-496-1813

e-MAIL: donna.morris@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kirkland L. Davis Office of Acquisition, Neurosciences Chief, NINDS R&D Contracts Management Branch, NIDA, NIH http://www.sam.gov/ mailto:donna.morris@nih.gov

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

SECTION I – CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF 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. Estimate of Effort

f. Commitment of Public Funds

g. Communications Prior To Contract Award

h. Release of Information

i. Preparation Costs

j. Service of Protest

k. Late Proposals and Revisions

l. Certification of Filing and Payment of Taxes

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. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. ROTC Access and Federal Military Recruiting on Campus

13. Past Performance Information

14. Information and Physical Access Security

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Proposal Format Instructions …

2. Technical Proposal Overview

3. Technical Capabilities and Discussions

4. Care and Use of Live Vertebrate Animals

5. Technical Proposal Budget Templates

6. Other Technical Proposal Considerations

7. Technical Proposal Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Proposal Format Instructions

2. Business Proposal Budget Templates

3. Uniform Assumptions

4. Basic Cost/Price Information

5. Other Business Proposal Requirements

SECTION M - EVALUATION FACTORS FOR AWARD

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 National Institute on Neurological Disorders and Stroke (NINDS) is pursuing Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts to assess the pharmacokinetics, toxicology and safety of promising compounds to support their eventual use as therapeutics. Under the auspices of the NIH Blueprint for Neuroscience Research Program, and more specifically the NIH Blueprint Neurotherapeutics Network (BPN), (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm), the Pharmacology and Toxicology for Therapeutics Program (PTTP) provides a critical component of the BPN drug development infrastructure.

PTTP supports all preclinical pharmacology and toxicology testing needed to inform lead discovery and the selection of a clinical candidate, as well as comprehensive studies needed for regulatory filings such as FDA Investigational New Drug (IND) applications to allow for clinical evaluation of the candidates. In addition, this contract can serve and be utilized for individual development projects outside the Blueprint Network.

ARTICLE B.2. - PRICES/COSTS

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

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

16.504. Any resultant IDIQ contract award will contain a guaranteed minimum of $50,000. The estimated maximum amount will be $174,470,000 during the 10 year ordering period of this contract.

b. This IDIQ contract has a total ordering period of 10 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). For this IDIQ award, the NINDS intends to issue Task Order #001 for Performance Area 1, “Management and Operations Support” concurrent with this award. This task order award will obligate the total price negotiated for the first year of performance under Performance Area 1, “Management and Operations Support.” This will be a fixed-price type Task Order with a term of 12 months and will contain nine (9) annual 12-month term options. The total fixed-price amount negotiated for each year under the Performance Area 1 Task Orders will be equally divided by the number of report deliverables specified for that period to establish a fixed-price per report deliverable amount. Payments will be made upon delivery and acceptance for these report deliverables.

Amounts negotiated for Task Order #001, Performance Area 1, “Management and Operations Support", plus all possible options, is as follows:

Contract Line Item Number (CLIN) and Description

Period of Performance

Amount ($)

CLIN 1 – Task Order #001 – Year 01 (12 months) Performance Area 1, “Management and Operations Support”

TBD

CLIN TBD - Option No. 1 - Year 02 (12 months) TBD

CLIN TBD - Option No. 2 - Year 03 (12 months) TBD

CLIN TBD - Option No. 3 - Year 04 (12 months) TBD

CLIN TBD - Option No. 4 - Year 05 (12 months) TBD

CLIN TBD - Option No. 5 - Year 06 (12 months) TBD

CLIN TBD - Option No. 6 - Year 07 (12 months) TBD http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm

CLIN TBD - Option No. 7 - Year 08 (12 months) TBD

CLIN TBD - Option No. 8 - Year 09 (12 months) TBD

CLIN TBD - Option No. 9 - Year 10 (12 months) TBD

Amounts for the base/initial Task Order and for each 12-month term option, if exercised, will be tracked separately with disbursements to correspond to the 12-month period in which those funds are properly chargeable.

c. Task Orders for Performance Area 2, “Pharmacology and Toxicology Studies”, for individual pharmacology and toxicology studies of investigational agents/therapeutics will be competed through a Task Order Request for Proposal (TORFP) process as the need arises. It is anticipated that these Task Orders will be cost-reimbursement completion and/or level of effort type orders and will have variable periods of performance. The Government anticipates the possibility of issuing 8-10 TORFPs under Performance Area 2 during each year of the contract. The actual number of TORFPs issued will depend upon programmatic needs and funding availability, and may vary from year to year. Due to changes in priorities within NINDS, the projected workload cannot be precisely described for each year.

d. Ordering procedures under this contract will be as described in Article G.3., Task Order Procedure, of this contract.

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.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. - STATEMENT OF WORK

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 (ATTACHMENT No. 3), attached hereto and made a part of this Solicitation in SECTION J.

ARTICLE C.2. – SPECIAL REQUIREMENTS

a. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature and shall not be released, disclosed, or otherwise disseminated to any person, organization, etc., except as otherwise directed by the Government.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

b. Data Rights

All data and the results emanating from or generated on the compounds provided by the Government, along with any summary reports compiled, are considered confidential based on the pre-existing agreements that the NINDS has established with compound sponsors. The contract restricts and prohibits the Contractor’s right to use, release to others, reproduce, distribute or publish data or other information resulting from testing/evaluations performed under contract. Such data shall not be releasable under the Freedom of Information Act (FOIA) as it is considered proprietary, i.e., trade secrets, and, therefore, could be determined to be exempt from FOIA. Restricted access to data and materials will be maintained at the Contractor’s facility in a secured manner. Special notices or other safeguards will be affixed to any packages containing such data.

c. Materials Transfer Agreement

Additionally, a Materials Transfer Agreement (MTA) may be necessary to implement with the Contributor/sponsor in order to transfer the investigational agent substance (as API or as final dosage formulation) to the Contractor.

Investigational agents will be provided by either the Government via a 3rd party Contractor or Contributor.

The Contractor shall comply with FDA regulations and Contractor’s SOPs for handling investigational agents. The Government or Contributor may request that the Material Transfer Agreement be put into place.

Receipt, handling, storage and disposition of investigational agents will be in compliance with Contractor’s SOPs and in compliance with FDA regulations. At the request of the Government, investigational agents may be returned as instructed by the Contracting Officer’s Representative (COR) at any time.

SECTION D - PACKAGING, MARKING AND SHIPPING

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

ARTICLE D.1. PACKAGING

For the purpose of reports, "immediately usable and acceptable condition" includes securing the pages together in a suitable and reasonable manner to be agreed upon by the Contracting Officer (CO) and the NINDS Contracting Officer's Representative (COR).

Boxes and/or other types of outer packaging, i.e., containers, wraps, etc., shall be suitable to the type of items being transmitted; and the mode of transportation utilized shall assure that such materials be received in an acceptable condition as needed.

ARTICLE D.2. MARKING

All reports and/or deliverable items under this contract shall be marked on the cover and cover page with the following identifiers.

1. Project Title: "Pharmacology and Toxicology for Therapeutics Program (PTTP)"

2. Contract Number:

3. Name of Contractor:

4. Name of Principal Investigator:

ARTICLE D.3. SHIPPING

Shipping shall be accomplished by reasonable and suitable means to be mutually agreed upon by the Contractor and the NINDS COR.

See Section F for delivery information.

SECTION E - INSPECTION AND ACCEPTANCE

ARTICLE E.1. – INSPECTION AND ACCEPTANCE

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

b. For the purpose of this Section, the NINDS COR is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at either the Contractor’s facility or at the NINDS.

Acceptance of work, materials, services, and reports 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 52.246-9, Inspection of Research and Development (Short

Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The total ordering period of this contract shall be from TBD 2016 through TBD 2026.

b. The performance period covered by award of Task Order #001 is TBD 2016 through TBD 2017. The period of Task Order #001 may be extended by exercise of additional term options. If the Government exercises the term option(s) made a part of Task Order #001 pursuant to the OPTION PROVISION, Article in SECTION H of this contract, the period of performance of Task Order #001 will be extended as follows:

Option Option Period

#1 - Term Extension Year 2 - TBD – 12 Months #2 - Term Extension Year 3 - TBD - 12 Months

#3 - Term Extension Year 4 - TBD - 12 Months #4 - Term Extension Year 5 - TBD - 12 Months #5 - Term Extension Year 6 - TBD - 12 Months #6 - Term Extension Year 7 - TBD - 12 Months #7 - Term Extension Year 8 - TBD - 12 Months #8 - Term Extension Year 9 - TBD - 12 Months #9 - Term Extension Year 10 -TBD - 12 Months

ARTICLE F.2. DELIVERIES

The items specified below, and as set forth in Article C.1., Statement of Work, Section 5, Reporting Requirements and Deliverables, shall be delivered F.o.b. Destination as set forth in FAR Clause 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), hereby made a part of this contract, and in accordance with and by the dates specified below:

Description Quantity Due Date

TECHNICAL REPORTS -

PERFORMANCE AREA 1

Quarterly Technical Progress Report 1 e-copy to the

CO and COR 5 calendar days after the end of months 3, 6, and 9 of each year.

The report covering the last quarterly period of each year is due on or before the completion / termination date of the Task Order year.

Final Contract Report 1 e-copy to the CO and COR

On or before the completion/termination date of the contract.

TECHNICAL REPORTS -

PERFORMANCE AREA 2

Task Order Data Reports 1 e-copy to the

Will be determined by terms of each individual Task Order

Draft Task Order Study Report 1 e-copy to the CO and COR

Will be determined by terms of each individual Task Order

Final Task Order Study Report 1 e-copy to the

Will be determined by terms of each individual Task Order

Report of Unexpected Event 1 e-copy to the CO and COR

Will be determined by terms of each trial Task Order

OTHER REPORT REQUIREMENTS

Roster of Employees Requiring Suitability Investigations (Monthly IT Roster)

1 e-copy to the CO and COR

Initial report due 14 days after contract award. Thereafter, due 5 calendar days after end of each monthly reporting period.

IT Security Plan 1 e-copy to the CO and COR

Due within 30 days after contract award

IT Risk Assessment 1 e-copy to the CO and COR

Due within 30 days after contract award

FIPS 199 1 e-copy to the CO and COR

Due within 30 days after contract award

IT SC&A 1 e-copy to the CO and COR

Due three (3) months after contract award.

Commitment to Protect Non-Public Information - Contractor Employee Agreement

1 e-copy to the CO and COR

Prior to any and all employees working under the contract.

Vulnerability Scanning Reports 1 e-copy to the CO and COR

1st report due 40 days after contract award. Monthly reports thereafter due 10 calendar days after end of each monthly reporting period.

Section 508 Annual Report - Electronic and Information Technology Accessibility –

1 e-copy to CO and COR

On or before the anniversary date of contract award.

Annual Invention Utilization Report

1 e-copy to the

CO

On or before the anniversary date of contract award.

Final Invention Statement 1 e-copy to the

CO

On or before the expiration/ termination date of the contract.

Individual Subcontract Report (ISR) Electronic Submission

April 30th and October 30th of each contract year; and a final report on or before expiration date of contract.

Summary Subcontract Report (SSR) Electronic Submission

October 30th of each contract year.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. 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).

The e-mail and mailing addresses for the Contract Specialist/Contracting Officer and Contracting Officer Representative (COR) are as follows:

Contract Specialist/Contracting Officer

NINDS R&D CMB, NIDA, NIH

6001 Executive Blvd., Room 3287 Bethesda, Maryland 20892- 9531 (FedEx/courier use:

Rockville, MD 20852) Email: donna.morris@nih.gov

COR:

(To be Named)

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: http://www.acquisition.gov/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984).

http://www.acquisition.gov/far

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 identified at time of contract award]

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

(5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an 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 in writing, any time during the contract’s period of performance.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to 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.

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

[To be identified at time of contract award]

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 Task Order has been awarded. The Contractor may only 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 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 in this contract shall be incorporated in the TORFP and the resultant Task Order by reference. 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 unless stated otherwise.

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 notifications 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 adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of the 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.

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 past performance or cost/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/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORTING

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH (RC)-2, is attached and made part of this contract. The Contractor shall follow the NIH (RC)-2 instructions for preparation and submission of invoices related to Task Order awards under Performance Area 1. In addition, the Contractor shall follow the procedure specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

b. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement

Contracts, NIH (RC)-4 is attached and made part of this contract. The Contractor shall follow the NIH (RC)-4 instructions for preparation and submission of monthly contract financing requests related to Task Order awards made under Performance Area 2. In addition, the Contractor shall follow the procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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 to the NIH Office of Financial Management. However, this information shall be submitted to the NINDS approving official.

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:

Donna Morris, Contract Specialist at: donna.morris@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."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice/contract financing request, 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:

Office of Acquisitions, Neurosciences (OAN).

b) Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is:

NIDA Invoices NINDS CMB.

c) Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d) DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e) Invoice Matching Option. This contract requires a two-way match.

f) Unique Invoice/contract financing request Number. Each payment request must be identified by a unique number, which can only be used one time regardless of the number of contracts or orders held by an organization.

g) Contract Title: “Pharmacology and Toxicology for Therapeutics Program (PTTP)”

f. Inquiries regarding payment of invoices/contract financing requests shall be directed to the designated billing office, (301) 496-6452.

g. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract”.

h. The Contractor agrees to provide with each monthly contract financing request a detailed breakdown of the direct labor/personnel charges claimed, to include: (1) a list of individuals by name; (2) their title/position under the contract; (3) their hourly/annual salary rate; (4) percent of effort charged; and (5) amount claimed for each.

i. The Contractor shall track, record, and report costs incurred separately for each Task Order award, and any option, if so exercised.

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. GOVERNMENT PROPERTY

If this Solicitation will result in the acquisition or use of Government Property provided by the Contracting Agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at:

http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf .

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

ARTICLE G.8. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

http://www.cpars.gov/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated TBD , which is incorporated by reference.

ARTICLE H.3. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq.

and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov ; Web site: ( http://www.aphis.usda.gov/animal_welfare ).

http://grants1.nih.gov/grants/olaw/references/phspol.htm mailto:ace@aphis.usda.gov http://www.aphis.usda.gov/animal_welfare http://www.aphis.usda.gov/animal_welfare

ARTICLE H.4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS

RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC:

http://www.pubmedcentral.nih.gov .

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html and http://publicaccess.nih.gov .

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.7. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.8. OPTION PROVISION

Option provision will only apply to Task Order awards made under this contract. There is no option provision applicable to the parent IDIQ award.

This ID/IQ contract has a total ordering period of 10 years. The NINDS intends to issue Task Orders for the Contractor to perform any or all of the Performance Activities listed in the Statement of Work (SOW). For this IDIQ award, the NINDS intends to issue Task Order #001 for Performance Area 1, “Management and Operations Support”, concurrent with the base IDIQ award. This Task Order will have a term of 12 months and will contain nine (9) additional 12-month term options. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract, set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, extend the term of the Task Order period for successive 12-month periods as set forth in the Statement of Work and also defined in SECTIONS C and F of the contract. If the Government exercises these options, notice of the Government’s intent to do so will be issued at least 30 days prior to the then current expiration date of the Task Order.

In addition to the Task Order term options addressed above, any Task Order awarded under Performance Area 2, “Pharmacology and Toxicology Studies”, may also include quantity options for the conduct of additional studies under that order. These options, if any and if exercised, will be done so pursuant to FAR Clause 52.217-7, Option for Increased Quantity – Separately Priced Line Item, set forth in SECTION I. of this contract. If the Government exercises such options, notice of the Government’s intent to exercise such option(s) will be given at least 7 days in advance of exercise of the option.

http://www.pubmedcentral.nih.gov/ http://www.pubmedcentral.nih.gov/ http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html http://publicaccess.nih.gov/ http://publicaccess.nih.gov/

ARTICLE H.9. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated TBD is attached hereto and made a part of this contract.

2. The failure of any Contractor or Subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages- Subcontracting Plan."

b. 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)

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 address:

donna.morris@nih.gov

ARTICLE H.10. INFORMATION AND PHYSICAL ACCESS SECURITY

a. HHS-Controlled Facilities and Information Systems Security

1. To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

2. To gain routine physical access to an HHS-controlled information system, and/or access to sensitive data or information, the Contractor and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; Office of Management and Budget Memorandum (M-05-24); and Federal Information Processing Standards Publication (FIPS PUB) Number 201; and with the personal identity verification and investigations procedures contained in the following documents:

http://www.esrs.gov/

a. HHS-OCIO Information Systems Security and Privacy Policy

(http://www.hhs.gov/ocio/policy/#Security)

b. HHS HSPD-12 Policy Document, v. 2.0

(http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05- 24.pdf)

c. Information regarding background checks/badges (http://idbadge.nih.gov/background/index.asp)

3. Position Sensitivity Levels:

This contract will entail the following position sensitivity levels:

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

[ ] Level 5: Public Trust - Moderate Risk.