RFP_15-01.pdf

RFP NIH-NINDS 15-01

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-15-01

3. Issue Date:

July 6, 2015

4. Set Aside:

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

5. Title : Phase 1 Clinical Trials for Development of Neurotherapeutics

6. ISSUED BY:

Office of Acquisitions, NIDA

NINDS R&D CMB, 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 the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:30p.m. local time on September 4, 2015. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR

HIS/HER DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF

ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN

ACCORDANCE WITH HHSAR CLAUSE 352.215-70, 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: Annette Carter

PHONE: 301-496-1813

e-MAIL: cartera@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Annette Carter Contracting Officer Office of Acquisition, Neurosciences NINDS R&D Contracts Management Branch, NIDA, NIH http://www.sam.gov/

RFP TABLE OF CONTENTS

PART I – THE SCHEDULE ……………………………………………………………………………………………

SECTION A - SOLICITATION/CONTRACT FORM …………………………………………………………

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS …………………………………………………...5

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT …………………………………………...7

SECTION D - PACKAGING, MARKING AND SHIPPING ………………………………………………………….…9

SECTION E - INSPECTION AND ACCEPTANCE ……………………………………………………………………10

SECTION F - DELIVERIES OR PERFORMANCE ……………………………………………………………………11

SECTION G - CONTRACT ADMINISTRATION DATA ………………………………………………………………14

SECTION H - SPECIAL CONTRACT REQUIREMENTS ……………………………………………………………20

PART II - CONTRACT CLAUSES ……………………………………………………………………………………...37

SECTION I – CONTRACT CLAUSES ………………………………………………………………………………….37

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS ………………………………….46

SECTION J - LIST OF ATTACHMENTS ………………………………………………………………………………46

PART IV - REPRESENTATIONS AND INSTRUCTIONS ……………………………………………………………47

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS ……47

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS …………………………….….48

1. GENERAL INFORMATION …………………………………………………………………………………………...48

a. Instructions to Offerors-Competitive Acquisition……………………..……………………………………………..48

b. NAICS Code and Size Standard………………………………………………………………………………………51

c. Type of Contract and Number of Awards…………….. ……………………………………………………………..52

d. Task Orders Under Multiple Award Indefinite Delivery Contracts ………………………. ……………………….52

e. Estimate of Effort………. ………………………………………………………………………………………………54

f. Commitment of Public Funds……… …………………………………………………………………………………55

g. Communications Prior To Contract Award……………...…………………………………………………….……...55

h. Release of Information………. ………………………………………………………………………………………..55

i. Preparation Costs……....………………………………………………………………………………………………..55

j. Service of Protest………..……………………………………………………………………………………………….55

k. Late Proposals and Revisions…………………………………………………………………………………………56

2. INSTRUCTIONS TO OFFERORS ……………………………………………………………………………………56

a. GENERAL INSTRUCTIONS …………………………………………………………………………………………..56

1. Contract Type and General Clauses …………………………………………………………………………………56

2. Authorized Official and Submission of Proposal …………………………………………………………………….56

3. Proposal Summary and Data Record (NIH-2043) …………………………………………………………………..57

4. Separation of Technical and Business Proposals …………………………………………………………………..57

5. Alternate Proposals …………………………………………………………………………………………………….57

6. Evaluation of Proposals ………………………………………………………………………………………………..57

7. Potential Award Without Discussions ………………………………………………………………………………...57

8. Use of the Metric System of Measurement …………………………………………………………………………. 57

9. Privacy Act - Treatment of Proposal Information ……………………………………………………………………58

10. Selection of Offerors …………………………………………………………………………………………………. .58

11. Institutional Responsibility Regarding Investigator Conflicts of Interest ………………………………………… 60

12. ROTC Access and Federal Military Recruiting on Campus ……………………………………………………… 60

13. Certification of Filing and Payment of Taxes ………………………………………………………………………..60

14. Past Performance Information ………………………………………………………………………………………. .60

15. Information and Physical Access Security ………………………………………………………………………….. 61

16. Solicitation Provisions Incorporated by Reference ………………………………………………………………… 71

b. TECHNICAL PROPOSAL INSTRUCTIONS ………………………………………………………………………… .72

1. Proposal Format Instructions ………………………………………………………………………………………….. 72

2. Technical Discussions ………………………………………………………………………………………………

3. Other Considerations ………………………………………………………………………………………………….. .77

4. Technical Evaluation ………………………………………………………………………………………………..…. .77

5. Human Subjects ………………………………………………………………………………………………………… 77

c. BUSINESS PROPOSAL INSTRUCTIONS ……………………………………………………………………………87

1. Proposal Format Instructions ……………………………………………………………………………………..…... 87

2. Business Proposal Budget Templates ……………………………………………………………………………..… .87

3. Uniform Assumptions ………………………………………………………………………………………………….. .88

4. Basic Cost / Price Information ……………………………………………………………………………………..…

5. Other Business Proposal Requirements…………………………………………………………………………....… 93

SECTION M - EVALUATION FACTORS FOR AWARD ……………………………………………………………...102

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) has the need for a full service, turn-key Phase I clinical trials operations and facility for the development of novel neurotherapeutic agents. This full service facility would provide a full range of services from protocol development/finalization and clinical trial execution through submission of a final clinical study report in support of an IND submission of the tested agent.

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 (ID/IQ) contract as contemplated by FAR

16.504. This IDIQ contract will contain a guaranteed minimum which will be the total price negotiated and awarded for the base/initial task order award for each awardee under Performance Area A. The base/initial task order will be awarded concurrently with the ID/IQ contract. The estimated ID/IQ maximum amount will be $19,500,000 during the 10 year ordering period of this contract.

b. This ID/IQ 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 A – Administrative and Overall Clinical Operations Support concurrent with this award. 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 the Performance Area A task orders will be equally divided by the number of quarterly progress and project management plan reports, five (5) in year 1 and four (4) in each subsequent option year, to establish a fixed-price per report deliverable amount. Payments will be made upon delivery and acceptance for these report deliverables.

Task Orders for Performance Area B – Clinical Trial Execution will be competed through a Task Order Request for Proposal (TORFP) as the need arises and will consist of a base requirement for protocol development and finalization and include a quantity type option for actual conduct of the trial called “trial execution. NINDS anticipates issuing approximately 1-2 TORFPs for Performance Area B during each year of the contract. The amount of work will depend upon the needs of NINDS and the availability of funds. The amount of work may vary from year to year. Due to changes in priorities within NINDS, the projected workload cannot be precisely described for each year.

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

d. Amounts negotiated for Task Order #001 – Performance Area A – Administrative and Overall Clinical 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 A – Administrative and Overall Clinical 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

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.

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, attached hereto (Attachment #3) 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. Privacy Act

All information on or relating to individuals participating under any Phase 1 trial conducted hereunder data is subject to the terms and conditions of the Privacy Act Clause (HHSAR 352.224.70) which will be made part of resultant contracts/Task Orders.

d. 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 COR at any time

e. Paperwork Reduction Act

Work under any Performance Area B task order will involve the collection of information from 10 or more individuals as part of clinical trial conduct. The information and statements collected will be obtained from individuals under treatment or clinical examination in connection with research on or relating to a clinical disorder. Thus, in accordance with 5 CFR 1320.3(h)(5), work under the Performance Area B task orders may be eligible for a Clinical Exemption from the OMB Clearance requirements as set forth in the Paperwork Reduction Act Clause, HHSAR 352.201-70 made a part of this contract in Article H.12. OMB Clearance and Section I.3., Paperwork Reduction Act. In order to obtain clinical exemption, specific protocols, including descriptions of eligibility criteria, recruiting methods and the populations and conditions to be studied, informed consent documents, etc… will be submitted to the NIH Clinical Exemption Review Committee (CERC). The COR will to apply for clinical exemption for Task Orders issued under Performance Area B, “Clinical Trial Execution” once protocols are developed. A clinical exemption will need to be approved before data collection activities can begin in performance of the trial itself.

SECTION D - PACKAGING, MARKING AND SHIPPING

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

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 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.

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: "Phase I Clinical Trials for Development of Neurotherapeutics"

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.16 of this contract, the period of performance of Task Order #001 will be extended as follows:

Option Option Period

PA A Term Extension Option TBD – 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

PA A Term Extension Option TBD - 12 Months

ARTICLE F.2. DELIVERIES

The items specified below, and as set forth in Article C.1., Statement of Work, Section 4, paragraph f., 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 PERFORMANCE

REPORTS

PERFORMANCE AREA A

Quarterly Progress Report 1 e-copy to the

CO and COR

5 calendar days after the end of the reporting period

Project Management Plan 1 e-copy to the

CO and COR

45 days after award of the contract.

PERFORMANCE AREA B

Final protocol and any related amendments/modifications, to include all required regulatory forms for contributor to obtain open IND for proposed trial (e.g.

FDA Form 1571 and 1572).

1 e-copy to the

CO and COR

3 weeks after task order award..

Manual of Operations (for each study)

1 e-copy to the

CO and COR

10 days after exercise of option

Summary Report for each Clinical Trial Initiation meeting

1 e-copy to the

CO and COR

2 business days after meeting

Locked database to be specified by the terms of each study protocol.

1 e-copy to the

CO and COR

Will be determined by terms of each trial Task Order

Draft clinical study report 1 e-copy to the

CO and COR

45 days after locking database

Final clinical study report 1 e-copy to the

CO and COR

15 days after receipt of comments from COR/CO

Annual report for each IND application

1 e-copy to the

CO and COR

Within 30 days of request of

COR

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 30 days after contract award.

IT Risk Assessment 1 e-copy to the

CO and COR

Due 30 days after contract award.

FIPPS 199 1 e-copy to the

CO and COR

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

Summary Subcontract Report

(SSR)

Electronic

Submission

October 30 th 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 Contracting Officer and Contracting Officer Representative (COR) are as follows:

Contracting Officer:

Annette Carter

NINDS R&D CMB, NIDA, NIH

6001 Executive Blvd., Room 3287

Bethesda, Maryland 20892-

9531 (FedEx/courier use:

Rockville, MD 20852)

Email: cartera@mail.nh.gov

COR:

(To be Named)

ARTICLE F.3. 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 352.242-70 (January 2006)

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

(End of Clause)

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

[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 an 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

REPORT

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 A. 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 Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH

Cost-Reimbursement Type Contracts 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 B. 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 Contracting Officer.

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

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

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

Office of Acquisitions

NINDS R&D CMB, NIDA

Neuroscience Center, Suite 3287 Bethesda, MD 20892-9531

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: Phase I Clinical Trials for Development of Neurotherapeutics

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 the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H 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 the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this 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 RFP 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 http://www.cpars.gov/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

c. If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) 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. The Contracting Officer may communicate the notice of suspension by telephone with confirmation 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, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Human Subject Assurances.

(End of clause)

ARTICLE H.2. HUMAN SUBJECTS

Performance of work under this contract requires the participation of human subjects. As such, the Contractor shall comply with the regulatory requirements of 45 CFR 46 entitled: "Protection of Human Subjects" and the HHSAR Clause 352.270-4(b), which are hereby incorporated and made a part of this contract by reference.

Research involving human subjects shall not be conducted under this contract or any Task Order award option under Performance Area B – entitled “Trial Execution” until the protocol developed in the “Protocol Development and Finalization” component has been approved by the NINDS and written notice of such approval has been provided to the Contractor by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor's self-designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990- 0263 (formerly Optional Form 310). In addition, the Contractor shall also provide a copy of the consent form that has been reviewed and approved by thir IRB, and which complies with the requirements of 45 CFR 46.

When research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain, and keep on file, a properly completed "Protection of Human Subjects Assurance

Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form

310) certifying IRB review and approval of the research.

ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html .

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html http://grants.nih.gov/grants/guide/notice-files/not99-107.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract. Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring Plan shall be established and submitted with each TORFP response.

Approval will be provided prior to beginning the conduct of the clinical trial.

ARTICLE H.5. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf , Title VIII, expands the National Institutes of Health's (NIH's) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified "applicable clinical trials," including those supported in whole or in part by NIH funds. FDAAA requires:

the registration of certain "applicable clinical trials" (see Definitions at:

http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm ) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and http://grants.nih.gov/grants/guide/notice-files/not98-084.html http://grants.nih.gov/grants/guide/notice-files/not99-107.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf%20 http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf%20 http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.

In addition, the Contractor shall notify the Contracting Officer's Representative (COR), with the trial registration number (NCT number), once the registration is accomplished. This notification may be included in the Quarterly Progress Report covering the period in which registration occurred, or as a stand-alone notification.

The Government is the Sponsor and delegates the Contractor's Principal Investigator as the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov ).

Additional information is available at: http://prsinfo.clinicaltrials.gov .

ARTICLE H.6. 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.