RFP_14-02_-_Drug_Manufacturing_and_Formulation_Program_(DMFP).pdf

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-14-02

3. Issue Date:

May 2, 2014

4. Set Aside:

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

5. Title : Drug Manufacturing and Formulation Program (DMFP)

6. ISSUED BY:

Office of Acquisitions

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 3:30p.m. local time on July 1, 2014. 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 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 Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Laurie A. Leonard

PHONE: 301-496-1813

e-MAIL: LL44S@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Laurie A. Leonard Contracting Officer Office of Acquisitions NINDS R&D Contracts Management Branch, NIDA 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

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

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. LEVEL OF EFFORT

f. COMMITMENT OF PUBLIC FUNDS

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

k. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Past Performance Information

13. Information and Physical Access Security

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Additional Technical Proposal Instructions

2. Technical Discussions

3. Other Considerations

4. Technical Evaluation

5. Obtaining and Disseminating Biomedical Research Resources

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

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Additional Business Proposal Instructions and Cost Assumptions

2. Basic Cost/Price Information

3. Proposal Cover Sheet

4. Data Other than Certified Cost or Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. Mentor Protégé Program, HHSAR 352.219-70

9. HUBZone Small Business Concerns

10. Extent of Small Disadvantaged Business Participation

11. Total Compensation Plan

12. Other Administrative Data

13. Qualifications of the Offeror

14. Subcontractors

15. Proposer's Annual Financial Report

16. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

PART I - THE SCHEDULE

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

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

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

IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE

ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY

INFORMATION TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. - BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This acquisition is for services to conduct studies that will support the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical and clinical studies of neurological disease/disorders. Services to be provided include: manufacture the active pharmaceutical ingredient (API), formulate the API, package, label, store, and distribute completed drug product.

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. The Contractor shall be reimbursed by the Government in an amount not less than a total of $25,000 (minimum), nor more than a total of $50.9 Million (maximum), for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period TBD 2015 through TBD 2025.

c. This ID/IQ Contract has a base award consisting of 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). To establish the base award, the NINDS intends to issue Task Order #001 for Performance Activity 1 – Technical Support concurrent with the base award. This will be a cost reimbursement, level of effort type task order with a term of 12 months and it will contain 9 annual 12 month term options. Task Order #001 will also include an option for maintaining Federal Information Security Management Act of 2007 (FISMA) compliance and keeping all the required documentation up-to-date (this maintenance option will only be awarded if a drug compound task order has been issued and FISMA Compliance has been met). Additional Task Orders will be competed through a Task Order Request for Proposal (TORFP) as the need arises. It is anticipated that these Task Orders will be cost-reimbursement, completion-type task orders and have variable Periods of Performance. NINDS anticipates issuing approximately three TORFPs for Performance Activity 2 (sub-activities 2.1. through 2.9.), and/or Performance Activity 3 (sub-activities 3.1. through 3.6.), during each year of the contract. NINDS may decide not to issue Task Orders for one or more of the performance sub-activities listed in the SOW. 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.

d. The total estimated amount negotiated for the base contract and Task Order #001 – Performance Activity #1

– Technical Support, plus all possible options thereafter is as follows:

Contract Line Item Number (CLIN) and Description

Period of Performance

Estimated Cost ($)

CLIN 1 – Task Order #001 – Year 01 (12 months) Performance Activity 1 – Technical Support

TBD

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

TBD

CLIN TBD – Option 1A – FISMA Maintenance TBD

CLIN TBD - Option No. 2 – PA #1 - Year 02 (12 months)

TBD

CLIN TBD – Option 2A – FISMA Maintenance TBD

CLIN TBD - Option No. 3 – PA #1 - Year 04 (12 months)

TBD

CLIN TBD – Option 3A – FISMA Maintenance TBD

CLIN TBD - Option No. 4 – PA #1 - Year 05 (12 months)

TBD

CLIN TBD – Option 4A – FISMA Maintenance TBD

CLIN TBD - Option No. 5 – PA #1 - Year 06 (12 months)

TBD

CLIN TBD – Option 5A – FISMA Maintenance TBD

CLIN TBD - Option No. 6 – PA #1 - Year 07 (12 months)

TBD

CLIN TBD – Option 6A – FISMA Maintenance TBD

CLIN TBD - Option No. 7 – PA #1 - Year 08 (12 months)

TBD

CLIN TBD – Option 7A – FISMA Maintenance TBD

CLIN TBD - Option No. 8 – PA #1 - Year 09 (12 months)

TBD

CLIN TBD – Option 8A – FISMA Maintenance TBD

CLIN TBD - Option No. 9 – PA #1 - Year 010 (12 months)

TBD

CLIN TBD – Option 9A – FISMA Maintenance TBD

Costs for the base contract and each 12-month option term will be tracked separately and disbursements will 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

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, Attachment No.3, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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: "Drug Manufacturing and Formulation Program"

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:

TBD during negotiations

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from MM/DD/2015 through MM/DD/2025.

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 PA 1 Term Extension Option #1 TBD PA 1 Term Extension Option #1 TBD PA 1 Term Extension Option #3 TBD PA 1 Term Extension Option #4 TBD PA 1 Term Extension Option #5 TBD PA 1 Term Extension Option #6 TBD PA 1 Term Extension Option #7 TBD PA 1 Term Extension Option #8 TBD PA 1 Term Extension Option #9 TBD

ARTICLE F.2. DELIVERIES

The items specified below, and as described in Articles C.2., C.3 and H.8 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:

Article C.1.

SectionE Item #

Description Quantity Due Date

1.a. Conference Call Summaries 1 e-copy to the CO and COR

Within 48 Hours after each call

1 b. Quarterly Reports

1 e-copy to the CO

5 days after each reporting period

1.c.1). API REPORTS: Final API Technology Transfer Report

Within 14 days of COR request

1.c.2) API REPORTS: Final API Process Development Report

1.c.3) API REPORTS: Final API Synthesis Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.c.4) API REPORTS: Final API Analytical Method Validation Reports

1 e-copy to the CO and COR

Within 14 days of COR request

1.c.5) API REPORTS: Final Analytical Qualification Reports

1 e-copy to the CO and COR

1.c.6) API REPORTS: Final Drug Product Process Development Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.c.7) API REPORTS: Final API Stability Reports

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.1) DRUG PRODUCT REPORTS:

Final Preformulation Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.2) DRUG PRODUCT REPORTS:

Final Drug Product Analytical Method Validation Reports

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.3) DRUG PRUDUCT REPORTS: Final Qualification Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.4) DRUG PRODUCT REPORTS:

Final Formulation Development Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.5) DRUG PRODUCT REPORTS:

Final CTM Manufacturing Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.6) DRUG PRODUCT REPORTS:

Final CTM Stability Reports

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.7) DRUG PRODUCT REPORTS:

Final Supply Management Report

1 e-copy to the CO and COR

Within 14 days of COR request

1.d.8) DRUG PRODUCT REPORTS:

Task Order Final Report

1 e-copy to the CO and COR

Within 14 days of COR request

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

On or before the expiration/ termination date of the contract

2.b. Roster of Employees Requiring Suitability Investigations

1 e-copy to the CO and COR

14 days after effective date of first drug compound task order

2.c. IT Security Plan (IT-SP) 1 e-copy to the CO and COR

30 days after effective date of first drug compound task order

2.d. IT Risk Assessment (IT-RA) 1 e-copy to the CO and COR

30 days after effective date of first drug compound task order

2.e. FIPS 199 Assessment 1 e-copy to the CO and COR

30 days after effective date of first drug compound task order

2.f. IT Security and Accreditation

(IT0SC&A)

1 e-copy to the CO and COR

90 days after effective date of first drug compound task order

2.g. Reporting of New and Departing Employees

1 e-copy to the CO and COR

Within 5 days of staffing changes

2.h. Contractor – Employee Non- Disclosure Agreement(s)

1 e-copy to the CO and COR

30 days after effective date of first drug compound task order

2.i. Vulnerability Scanning Reports 1 e-copy to the CO

2.j. Section 508 Annual Report 1 e-copy to the CO

Annually and at contract completion

2.k. Information Security Training Report 1 e-copy to the CO and COR

14 days after effective date of first drug compound task order

Article C.1

Annual Invention Utilization Report

On or before the completion date of each reporting period.

Article H.7 Individual Subcontract Report (ISR) Electronic Submission

April 30th and October 30th of each Period of Performance

Article H.7 Summary Subcontract Report (SSR) Electronic Submission

October 30th of each Period of Performance

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

See Article C.1.E.2., subparagraph (j), and Article H.9.

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:

Laurie Leonard

NINDS R&D CMB, NIDA, NIH

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

Rockville, MD 20852) Email:

COR:

(To be Named)

ARTICLE F.3. LEVEL OF EFFORT (ONLY APPLICABLE TO PERFORMANCE ACTIVITY 1 – TASK ORDER #001)

a. During the period of performance of Task Order #001 - Performance Activity 1, the Contractor shall provide 15% direct labor effort as specified below. This same effort shall be provided with all subsequent performance activity 1 term options. The labor effort excludes vacation, holiday, and sick leave. It is estimated that the labor effort is constituted as specified below and will be expended approximately as follows:

Performance Activity 1 Labor Percent of Effort Category TO

#001 Option Option Option Option Option Option Option Option Option

Principal Investigator

10% 10% 10% 10% 10% 10% 10% 10% 10% 10%

Admin Assistant

5% 5% 5% 5% 5% 5% 5% 5% 5% 5%

Totals 15% 15% 15% 15% 15% 15% 15% 15% 15% 15%

b. The Contractor shall have satisfied the requirement herein if not less than 90% of the total effort is furnished.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984).

http://www.acquisition.gov/far

SECTION G – CONTRACT ADMINISTRATION DATA

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

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

[To be identified at time of contract award]

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

The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation in writing, any time during the contract’s period of performance.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (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. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

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

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail 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 cost or price. However, each TORFP will specify how the award decision will be made.

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

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

e. Fair Opportunity

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

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

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

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

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

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

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

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

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

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

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

Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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

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

National Institutes of Health Office of Financial Management Commercial Accounts

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

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

Contracting Officer Office of Acquisitions

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: Drug Manufacturing and Formulation Program (DMFP)

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

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 the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this contract."

d. 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.

1) The Contractor shall track, record, and report costs incurred separately for TO #001 and for each successive Option and Task Order exercised as set forth in Article B.2.

The performance period associated with TO #001 and each successive option as itemized in Article B.2 represents separate and distinct 12-month periods for each. In order to be in compliance with obligation and disbursement regulations and associated Appropriations Law, all invoices must reflect the performance period for each, i.e., for TO #001 and each successive Option and Task Order so exercised, respectively, costs were incurred under TO #001 - Performance Activity 1.

The Contractor shall also track, record and report costs incurred separately for each Performance Activity Task Order including sub-activities contained in Article B.3. in the same manner described above.

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://www.hhs.gov/hhsmanuals/logisticsmanual/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.

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.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf http://www.cpars.gov/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING

FROM NIH-FUNDED RESEARCH

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

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08- 033.html .

ARTICLE H.3. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds 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)).

http://www.pubmedcentral.nih.gov/ http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html

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.

ARTICLE H.6. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Award of the Statement of Work and Task Order #001 – Performance Activity 1 – Technical Support, as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost of the contract will be increased as set forth in the ESTIMATED COST ARTICLE in SECTION B of this contract.

ARTICLE H.7. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

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

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

b. Subcontracting Reports

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

1. Individual Subcontract Reports (ISR)

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

http://www.esrs.gov/

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

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

October 30th

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

ARTICLE H.8. INFORMATION AND PHYSICAL ACCESS SECURITY

a. HHS-Controlled Facilities and Information Systems Security

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

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

a) HHS-OCIO Information Systems Security and Privacy Policy

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

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

(http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m0 5-24.pdf)

c) Information regarding background checks/badges (http://idbadge.nih.gov/background/index.asp) http://www.hhs.gov/ocio/policy/%23Security http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf http://idbadge.nih.gov/background/index.asp

3. Position Sensitivity Levels:

This contract will entail the following position sensitivity levels:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level

6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to

Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

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

4. The personnel investigation procedures for Contractor personnel require that the Contractor prepare and submit background check/investigation forms based on the type of investigation required. The minimum Government investigation for a non-sensitive position is a National Agency Check and Inquiries (NACI) with fingerprinting. More restricted positions - i.e., those above non-sensitive, require more extensive documentation and investigation.

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access and/or maintain a Federal Information System(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days after the effective date the first drug compound task order. The Contracting Officer shall notify the Contractor of the appropriate level of suitability investigations to be performed. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

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

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

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

All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract.

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

Contractors may begin work after the fingerprint check has been completed.

5. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14.

Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

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

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

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

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

b. Standard for Security Configurations, HHSAR 352.239-70, (January 2010)

1. The Contractor shall configure its computers that contain HHS data with the applicable Federal

Desktop Core Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level. Note: FDCC is applicable to all computing systems using Windows XPTM and Windows VistaTM, including desktops and laptops - regardless of function - but not including servers.

The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS. The following security configuration requirements apply:

2. The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings - seehttp://nvd.nist.gov/validation.cfm. The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest FDCC major version and subsequent major versions.

3. The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges.

4. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

5. The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant

( http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security Presidential Directive12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification.

6. The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause.

c. Standard for Encryption language, HHSAR 352.239-71, (January 2010)

1. The Contractor shall use Federal Information processing Standard (FIPS)…