toc.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

NIMH -08-DS-00009

3. Issue Date:

June 5, 2008

4. Just in Time:

[X]No

[ ]Yes See Part IV Section L

5. Set Aside:

[X]No

[ ]Yes See Part IV Section L

6. Title : Recovery After an Initial Schizophrenic Episode (RAISE)

7. ISSUED BY:

Office of Acquisitions NIMH R&D Contracts Management Branch NIDA Neuroscience COAC National Institutes of Health 6001 Executive Blvd., Rm. 8154 Bethesda, MD 20892-9661

8. SUBMIT OFFERS TO:

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

9. 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 3:00 PM local time on August 4, 2008. 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.

10. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO TWO DIFFERENT LOCATIONS.

THE OFFICIAL POINT OF RECEIPT FOR THE PURPOSE OF DETERMINING TIMELY DELIVERY IS

THE ADDRESS PROVIDED FOR THE OFFICE OF ACQUISITIONS AS STATED IN ATTACHMENT 1,

"PACKAGING AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR CLAUSE 352.215-70, ENTITLED, "LATE PROPOSALS, AND REVISIONS" LOCATED IN SECTION L.1. OF

THIS SOLICITATION.

11. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

12. FOR INFORMATION CALL: Kathleen Giuliano

PHONE: 301-443-6427

e-MAIL: giuliank@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

All questions should be made in writing by email to:

giuliank@mail.nih.gov by the dates listed below.

First cutoff date for questions - June 19, 2008

Second cutoff date for questions - July 17, 2008

Suzanne Stinson Chief Contracting Officer Office of Acquisitions National Institute of Mental Health http://www.ccr.gov http://www.ccr.gov

RFP Number : NIMH -08-DS-00009

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

- 3 -

11. Selection of Offerors

12. Institutional Responsibility Regarding Conflicting Interests of Investigators

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Electronic and Information Technology Accessibility

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. Instructions to Offerors Regarding Protection of Human Subjects

6. Required Education in the Protection of Human Research Participants

7. Inclusion of Women and Minorities in Research Involving Human Subjects

8. Inclusion of Children in Research Involving Human Subjects

9. Research Involving Prisoners as Subjects

10. Data and Safety Monitoring in Clinical Trials

11. Obtaining and Disseminating Biomedical Research Resources

12. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Cost and Pricing Data

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

5. Salary Rate Limitation in Fiscal Year 2007

6. HUBZone Small Business Concerns

7. Extent of Small Disadvantaged Business Participation

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Representations and Certifications - SECTION K

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. HUMAN SUBJECT EVALUATION

3. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION CRITERIA

6. PAST PERFORMANCE FACTOR

7. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

- 4 -

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 first episode is a critical moment in the course of schizophrenia, and a unique opportunity for intervention. Many first episode patients are symptom free after stabilization on an antipsychotic, but over time, as relapses mount (with treatment as usual), vocational, and social functions deteriorate. The best, perhaps only chance for altering this dismal prognosis, is to intervene at the first episode. Antipsychotic drugs and rehabilitative interventions have been shown to be effective throughout the course of illness (relative to no treatment), but their ability to reverse long-term functional decline is limited.

The "Recovery After an Initial Schizophrenic Episode" (RAISE) initiative seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. The specific aims of this initiative are:

1. To develop a comprehensive and integrated treatment intervention that can be delivered in real world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning;

2. To test its feasibility and practical implementation in the community; and

3. To assess its overall clinical impact and cost-effectiveness as compared to currently prevailing treatment approaches.

ARTICLE B.2. PRICES/COSTS

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

ARTICLE B.3. ESTIMATED COST AND FIXED FEE

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

- 5 -

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period: Phase I -

Option Periods:

Phase II -

Phase III -

Grand Total Including

Base Period and two (2) Options

e. Total funds currently available for payment and allotted to this contract are $ of which $ represents the estimated costs, and of which $ represents the fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

f. It is estimated that the amount currently allotted will cover performance of the contract through .

g. The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

ARTICLE B.4. 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) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.5. 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.

- 6 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated June 5, 2008, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 2 hard copies of these reports will be sent to the Contract Officer/Contract Specialist:

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

Item Description Quantity Delivery Schedule

(1)

Monthly Report

1 Each

Email PDF to Project Officer & Contract Specialist

Due by: TBD

(2)

Annual Report

Hard Copy to Project Officer & Contract

(3)

Final Report

Hard Copy to Project Officer & Contracting Officer

Services and Deliverables are required upon the completion of each Phase.

- 7 -

PHASE 1: Refining the Intervention

Services

• Provide a list of parties that will provide external feedback regarding the proposed multi-element intervention, i.e., domestic and foreign experts in first episode schizophrenia research and clinical care, mental health consumers, relatives, advocates, etc. Describe how feedback will be acquired, e.g., independent manual review, meetings, focus groups, etc. Get GPO approval.

• Develop consent documents for patients and clinicians who will participate in the intervention refinement phase; pilot the multi-element intervention with a small number of real world clinicians and patients; obtain iterative feedback regarding the acceptability of treatment procedures.

• Develop or adapt measures of (1) diagnosis, clinical and functional outcomes, the cost of providing care; (2) provider acceptance, competency, and adherence to the intervention protocol; (3) patient and family satisfaction with treatment; and (4) measures of attrition and adverse events. Develop data collection and data management procedures for the feasibility study and practical clinical trial.

• Identify at least two non-academic, real world clinic sites to host the feasibility test; document that the flow of first episode patients is adequate to support the Phase 2 feasibility study; identify clinical staff at the real world clinics who will deliver the intervention, describe the training and supervision plan for study clinicians, describe the comparison condition and the randomization plan, and initiate IRB approval for the feasibility trial.

• Identify the operations personnel who will oversee day-to-day activities related to the fidelity test.

Deliverables

• Produce a revised treatment manual that reflects iterative feedback obtained in Phase 1; produce clinician training manuals to be used in the Phase 2 feasibility study.

• Produce a manual that describes and operationalizes the comparison treatment.

• Produce memoranda of agreement with representatives of at least two real world service sites that agree to field the Phase 2 feasibility study. Document that the flow of first episode patients is adequate to support the Phase 2 feasibility study. Verify that clinicians selected for the feasibility trial are representative of clinicians normally found at well-staffed mental health clinics.

o Identifying appropriate service delivery system partners for the feasibility study is a crucial evaluation criterion for progressing to Phase 2.

• Provide the randomization plan; document that real world service sites agree to abide by the randomization plan.

• Produce consent documents for patients and clinicians who will participate in the Phase 2 feasibility study.

• Deliver a variable list, compile assessment instruments, and describe the data acquisition and data management plan for the Phase 2 feasibility study.

• Produce evidence that IRB review of Phase 2 protocol is underway.

• Identify costs associated with completing Phase 2.

NIMH determines whether or not to continue to Phase 2.

PHASE 2: Conducting a Feasibility Study

Services

• Obtain IRB approval for all participating sites.

• Obtain DSMB review of protocol; make necessary modifications.

• Develop the electronic database, data collection instruments, and operations manuals for the feasibility trial; conduct training on intervention delivery, protocol, and trial operations.

• Conduct the feasibility study involving ~40 patients across at least two non-academic, real world treatment sites treated for approximately 12-months with randomization to experimental and comparison conditions; include appropriate monitoring, reporting, and DSMB oversight.

• Analyze data from the trial; present results to GPO.

• Extend agreements with Phase 2 sites to continue to Phase 3 clinical trial; establish agreements with additional real world clinical sites to participate in Phase 3; establish that the flow of first episode patients is adequate to support the Phase 3 practical clinical trial.

- 8 -

• Design protocol for Phase 3 practical clinical trial based on results of Phase 2 feasibility trial.

Deliverables

• Deliver the database for ~40 representative patients treated with the intervention for approximately 12 months, together with the relevant statistical analyses for demonstrating feasibility (i.e., that the randomization plan is reasonable, that the multi-element treatment can be delivered in real world settings, that patients and clinicians accept the intervention, and that baseline, treatment delivery, outcome, and cost data can be collected for experimental and comparison subjects).

o An important consideration for moving forward to the Phase 3 practical clinical trial is whether adequate baseline, treatment delivery, outcome, and cost data can be collected for experimental and comparison subjects.

• If necessary, produce revised treatment and clinician training manuals that incorporate lessons learned during the feasibility study.

• Develop a draft protocol and recommendations for conducting the randomized practical trial in Phase 3.

• Produce memoranda of agreement with representatives of original and additional real world service sites that agree to field the Phase 3 practical trial. Document that the flow of first episode patients is adequate to support the Phase 3 practical clinical trial. Verify that clinicians selected for the RTC are representative of clinicians normally found at well-staffed mental health clinics.

o Identifying appropriate service delivery system partners for the practical clinical trial is a crucial evaluation criterion for progressing to Phase 3.

• Document that real world service sites agree to abide by the randomization plan.

• Produce consent documents for patients who will participate in the Phase 3 practical clinical trial.

• Deliver a variable list, compile assessment instruments, and describe the data acquisition and data management plan for the Phase 3 RTC.

• Produce evidence that IRB review of Phase 3 protocol is underway.

• Identify costs associated with completing Phase 3.

NIMH determines whether or not to continue to Phase 3.

PHASE 3: Conducting a Practical Clinical Trial

Services

• Obtain IRB approval for all participating sites.

• Obtain DSMB review of protocol; make necessary modifications.

• Register the study in the National Library of Medicine's ClinicalTrials.gov database as required ( http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm#q2).

• Finalize development of the electronic database, data collection instruments, and operations manuals for the RTC; conduct training on intervention delivery, protocol, and trial operations.

• Conduct RTC; include appropriate monitoring, reporting, and DSMB oversight.

• Analyze data from the trial; present results to GPO.

• Organize roundtable meetings for discussion and interpretation of results of RCT, policy decision impact, greater dissemination in health systems.

Deliverables

• Deliver a final de-identified electronic dataset (with end-user documentation) consisting of all data elements, summary scores, and derive variables from the randomized clinical trial.

• Submit for publication a report on the clinical and cost effectiveness of the innovative intervention as compared with an ecologically valid comparison treatment.

2. Annual Technical Progress Report for Clinical Research Study Populations

- 9 -

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity.

b. Other Reports/Deliverables

1. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

2. Multiple Principal Investigators Leadership Plan The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040-A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

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

Attention: Contracting Specialist, Kathleen Giuliano Office of Acquisitions NIMH R&D Contracts Management Branch NIDA Neuroscience COAC National Instiute of Health http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

- 10 -

6001 Executive Blvd, Room 8157 Bethesda, MD 20892- 9661

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

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

http://www.iedison.gov

- 11 -

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.

- 12 -

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Project Officer (name to be provided at award) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute for Mental Health, 6001 Executive Blvd.

Bethesda, MD 20892

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

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

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

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

- 13 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from effective date of contract through end of Phase One (1).

ARTICLE F.2. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from effective date of contract through end of Phase One (1).

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

Option Option Period

Option Phase Two

To be determined

Option Phase Three

To be determined

ARTICLE F.3. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract. will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract: See Attachment 3.

Item Description Quantity Delivery Schedule

(1)

Monthly Report

Email PDF to Project Officer & Contract

(2)

Annual Report

Hard Copy to Project Officer & Contract

(3)

Final Report

Hard Copy to Project Officer & Contracting Officer

- 14 -

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

Addressee Deliverable Item No Quantity

Project Officer (TBD) TBD TBD

Contracting Officer/Contract Specialist (TBD)

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/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

http://www.acquisition.gov/comp/far/index.html

- 15 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER

The Project Officer (to be provided in the resultant contract) will represent the Government for the purpose of this contract:

This section will be completed at contract award

The Project Officer 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 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; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

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

(End of Clause)

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

Name Title

To be specified prior to award Principal Investigator

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

a. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts NIH(RC)-1 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted as follows:

a. One original to the following designated billing office:

National Institutes of Health Office of Financial Management

- 16 -

Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy to the following approving official:

Kathleen Giuliano - Contract Specialist Office of Acquisitions- NIH NIMH R&D Contracts Management Branch NIDA Neuroscience COAC Room 8157 6001 Executive Blvd MSC 9661 Bethesda, MD 20892- 9661

2. In addition to the requirements specified in FAR Subpart 32.9 for a proper invoice, the Contractor shall include the following information on all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Neuroscience COAC .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIDA Invoices NIMH CMB (NIH/NIDA) .

c. Vendor Identification Number. This is the 7 digit number that appears after the Contractor's name in Block 7 of Standard Form 26.

d. DUNS number or DUNS+4 that identifies the Contractor's name and address exactly as stated on the face page of the contract.

e. Identification of whether payment is to be made using a two-way or three-way match. This contract requires a Two-Way match.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) - 496-6088.

c. 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 P.L. 110-161 Division G, Title 2, Section 203and the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract." .

E-Mail: giuliank@mail.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official in lieu of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in a format compatible with the computer systems at NIH [e.g., MS Word, MS Excel, or Adobe Portable Document Format (PDF). 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."

- 17 -

ARTICLE G.4. 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, "Contractor's Guide for Control of Government Property," which can be found at:

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm.

ARTICLE G.5. 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

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) shall be submitted TBD at contract award [Insert Dates].

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.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm http://oamp.od.nih.gov/OD/CPS/cps.asp

- 18 -

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved by TBD at time of award (INSERT IC), written notice of such approval has been provided 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).

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.2. 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.3. 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.

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

- 19 -

The Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial.

ARTICLE H.4. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

ARTICLE H.5. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of 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 from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a 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).

ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

a. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited from using appropriated funds to support human embryo research. Contract funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings b.

Public Law and Section No. Fiscal Year Period Covered

P.L. 110-161, Division G, Title V, Section

2008 (10/1/2007 -9/30/2008)

[applicable information to be included at award]

- 20 -

ARTICLE H.7. NEEDLE EXCHANGE

a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

b.

Public Law and Section No. Fiscal Year Period Covered

P.L. 110-161, Division G, Title V, Section 505

2008 (10/1/2007 - 9/30/2008)

ARTICLE H.8. PRESS RELEASES

a. Pursuant to Public Law(s) cited in paragraph b., below, 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.

b.

Public Law and Section No. Fiscal Year Period Covered

P.L. 110-161 Division G, Title V, Section 508

ARTICLE H.9. ANTI -LOBBYING

a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall only be used for normal and recognized executive-legislative relationships. Contract funds shall not be used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

b. Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

c.

Public Law and Section No. Fiscal Year Period Covered

P.L. 110-161, Division G, TitleV, Section 503

ARTICLE H.10. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF

CONTROLLED SUBSTANCES

a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to support activities that promote the legalization of any drug or other substance included in schedule I of the schedules of controlled

- 21 -substances established by section 202 of the Controlled Substances Act (21 U.S.C. 812). This limitation shall not apply when the contractor makes known to the contracting officer that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

b.

Public Law and Section No. Fiscal Year Period Covered

P.L. 110-161, Division G. Title V, Section 510

ARTICLE H.11. MULTIPLE PRINCIPAL INVESTIGATORS

The NIH awarded this contract as a multiple Principal Investigators project. The Key Personnel Article in SECTION G of this contract designates the Contact Principal Investigator and all other Principal Investigators.

Contracts designating multiple Principal Investigators require a current Leadership Plan with updates as needed.

The Contractor's Leadership Plan, dated __________, (and as modified thereafter, in accordance with the Reporting Requirements Article in SECTION C of this contract), is hereby incorporated by reference.

ARTICLE H.12. PRIVACY ACT, HHSAR 352.270-11 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term ''system of records'' means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C.

552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as HHS employees. These provisions also apply to all subcontracts awarded under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)).

The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work to be performed by the Contractor; and (b) specifies the disposition to be made of such records upon completion of contract performance.

(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

The Privacy Act System of Records applicable to this project is Number . This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http:// oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.

ARTICLE H.13. OMB CLEARANCE

In accordance with HHSAR 352.270-7, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Project Officer and the Contracting Officer has issued written approval to proceed.

http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm

- 22 -

ARTICLE H.14. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.