NIDA_RFP_No._N01DA-15-7793.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321 as amended.

2. Request for Proposal (RFP) Number:

N01DA-15-7793

3. Issue Date:

September 26, 2014

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Production, Analysis, and Distribution of Cannabis and Related Materials

6. ISSUED BY:

NIDA R&D Contracts Management Branch Office of Acquisitions National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard, Room 4211 - MSC 9559 Bethesda, MD 20892-9559* *For Fed-Ex or hand delivery service, use:

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 3:00 PM local time on November 10, 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." The OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. 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: Andrew Hotaling, Contract Specialist.

PHONE: (301) 443-6677

e-MAIL: hotalingar@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kenneth E. Goodling Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA/NIH http://www.sam.gov

RFP Number : N01DA-15-7793

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

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. Standards for Privacy of Individually Identifiable Health Information

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

16. Information and Physical Access Security

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. PAST PERFORMANCE FACTOR

7. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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PART I - THE SCHEDULE

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

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

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

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

In brief, the objectives are to: (1) cultivate and harvest, process, analyze, store, and distribute cannabis (marijuana) for research; (2) extract cannabis to produce pure and standardized (current Good Manufacturing Practices (cGMP)-grade) cannabis extracts containing varying concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); (3) isolate cGMP and research grade THC, CBD, and other cannabinoids; (4) periodically analyze cannabis extracts, and isolated cannabinoids for authenticity, purity and stability; (5) develop new methods for growing cannabis plants containing high THC, low CBD; high CBD, low THC; and equal strength of CBD and THC; (6) manufacture, analyze, determine stability, store, and supply marijuana cigarettes; and (7) supply cannabis, cannabis extract, other cannabinoids, and marijuana cigarettes to research investigators and/or to the NIDA Drug Supply program upon NIDA authorization.

ARTICLE B.2. ESTIMATED COST - OPTION

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 direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

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.

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 $ .

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 (Contract Year 1)

Option Period 1 (Contract Year 2)

Option Period 2 (Contract Year 3)

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 3 (Contract Year 4)

Option Period 4 (Contract Year 5)

Total

[Base Period and Option Period(s)]

Option Quantities:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Quantity 1a: Cultivation of Cannabis - 1.5 acres (may be exercised a maximum of two times per Contract Year):

Base Period (Contract Year 1):

Option Period 1 (Contract Year 2):

Option Period 2 (Contract Year 3):

Option Period 3 (Contract Year 4):

Option Period 4 (Contract Year 5):

Option Quantity 1b: Cultivation of Cannabis - 6.5 acres (may be exercised a maximum of one time per Contract Year):

Option Quantity 1c: Cultivation of Cannabis - 12 acres (may be exercised a maximum of one time per

Option Quantity 2a: Production of Cannabis Extract - 10 Kilograms (Kg) (may be exercised a maximum of four times per Contract Year):

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Quantity 2b: Production of Cannabis Extract - 50 Kg (may be exercised a maximum of one time per

Option Quantity 2c: Production of Cannabis Extract - 100 Kg (may be exercised a maximum of one time per

Option Quantity 3: Development and cGMP Manufacturing of Cannabis Extract Formulation Dosage Form (may be exercised a maximum of three times per Contract Year):

Option Quantity 4a: Manufacturing of Cannabis (Marijuana) Cigarettes (may be exercised a maximum of five times per Contract Year):

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Quantity 4b: Manufacturing of Cannabis (Marijuana) Cigarettes (may be exercised a maximum of five

Option Quantity 4c: Manufacturing of Cannabis (Marijuana) Cigarettes (may be exercised a maximum of three

Option Quantity 5 - Training and Transitional Support (may be exercised one time in the final Contract Year)

Option Quantity 6: Analysis of Confiscated Marijuana Samples (may be exercised a maximum of five times per Contract Year):

Option Year 1 (Contract Year 2):

Option Year 2 (Contract Year 3):

Option Year 4 (Contract Year 5):

Total for all Option Quantities [Base Period and Option Period(s)]:

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ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award. NIDA reserves the right to have the contracted services in this contract benefit NIDA and other components of NIH.

[The remainder of this page is intentionally left blank.]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

I. Background Information and Objectives

A. Background Information:

The primary purpose of this contract is to provide materials to support research on marijuana (cannabis) and its constituents. Studies require a source of cannabis materials with consistent and predictable potency, free of contamination and in sufficient amounts to support a wide variety of research needs. Such production was established in the late 1960's by the Federal Government and this present procurement is a continuation of that effort.

Currently, due to the requirements of the 1961 Single Convention on Narcotic Drugs, there is a single Government entity that controls the production and distribution of marijuana for medical and research purposes. The US Drug Enforcement Agency (DEA) has licensed a contractor of the National Institute on Drug Abuse (NIDA) to grow, process, and distribute marijuana on behalf of the United States (U.S.) Government. In addition, chemical constituents of marijuana, such as delta-9-tetrahydrocannabinol (THC) and other cannabinoids are difficult to obtain commercially in sufficient quantities or are very expensive to purchase for research. Therefore, NIDA has been providing the research community with standardized samples of cannabis, various cannabinoids and other drugs of abuse for basic and clinical research through its Drug Supply Program.

B. Objectives:

The main objectives of this contract are to: (1) cultivate and harvest, process, analyze, store, and distribute cannabis (marijuana) for research; (2) extract cannabis to produce pure and standardized (current Good Manufacturing Practices (cGMP)-grade) cannabis extracts containing varying concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); (3) isolate cGMP and research grade THC, CBD, and other cannabinoids; (4) periodically analyze cannabis extracts, and isolated cannabinoids for authenticity, purity and stability; (5) develop new methods for growing cannabis plants containing high THC, low CBD; high CBD, low THC; and equal strength of CBD and THC; (6) manufacture, analyze, determine stability, store, and supply marijuana cigarettes; and (7) supply cannabis, cannabis extract, other cannabinoids, and marijuana cigarettes to research investigators and/or to the NIDA Drug Supply program upon NIDA authorization.

II. Services to Be Performed

A. General Requirements:

Independently, and not as an agent of the Government, the Contractor shall be required to furnish all necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements specified below:

The Contractor shall produce cannabis, cannabis extract, other cannabis-derived materials, and cannabis cigarettes for basic and clinical research, their quantitative and qualitative analysis, stability determination, and storage and shipment for research. Cannabis is used in a large variety of research projects and this contract serves as the only legal source of such material in the U.S. The Contractor shall grow sufficient quantities of cannabis to meet anticipated needs as directed by the NIDA Contracting Officer's Representative (COR), followed by careful quantitative analysis and storage prior to marijuana cigarette manufacturing and/or shipment for research. NIDA supplies research investigators with cannabis and its main psychoactive component, delta-9-THC, and other non-psychoactive components such as cannabinol (CBN), CBD, cannabichromene (CBC), cannabigerol (CBG), other cannabinoids, and marijuana cigarettes.

In order to meet present and anticipated needs for phytocannabinoids, the Contractor shall extract cannabis to isolate pure THC and other cannabinoids, obtain cannabis extract of known potencies, manufacture marijuana cigarettes of varying potencies, and provide purified materials and marijuana cigarettes for research and/or to the NIDA Drug Supply program, as directed by the COR. Cannabis and cannabis cigarettes provided through this contract are not available commercially or through any other legal sources. Similarly, cannabinoids such as THC, CBD and other

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The Contractor shall grow cannabis, produce research and cGMP-grade cannabis and cannabis cigarettes, and maintain a stock of cannabis preparations such as cigarettes of varying potencies, various cannabinoids, and cannabis extracts for distribution to fulfill requirements set forth below. The Contractor shall analyze cannabis samples, and cigarettes for cannabinoid contents. All pertinent Food and Drug Administration (FDA) and DEA requirements (e.g., cGMP) must be met for the cannabis preparations. The Contractor shall serve as NIDA's cannabis drug repository and keep these products in proper storage conditions to maintain their purity, integrity and strength.

All work under this contract shall be monitored by the Government COR who is defined in Section G of this contract.

B. Specific Requirements:

Specifically, the Contractor shall perform the following:

1. Produce and maintain an inventory of cannabis of different varieties as required by NIDA. More specifically, the Contractor shall:

a. Plant, grow, and harvest research/cGMP-grade cannabis (composed predominantly of but not limited to Mexican and Colombian varieties and occasionally, Indian, Turkish, or other varieties) for basic and clinical research. The Contractor shall carry out harvesting by selecting appropriate plant parts and appropriate harvest time as to day and hour based on continuous monitoring of plants by chemical analysis for key cannabinoids. In order to minimize spoilage, the Contractor shall dry the collected material in an efficient and expeditious manner and place it in the storage. Disposal of all waste materials is inclusive to this task.

Note: The current inventory of cannabis under the predecessor contract shall be available for initial use under this contract. The Contractor shall grow a minimum quantity of approximately 10 Kilograms (Kg) of cannabis indoor or outdoor every year to supplement and replace existing marijuana stocks during the contract duration. If additional quantity is required, NIDA will exercise Option Quantity 1 (1.5, 6.5, or 12 acres).

b. Determine the major cannabinoids contents in harvested and inventoried cannabis by gas liquid chromatography (GLC) and/or any other suitable technique. Minimally, this will require the quantification of delta-9-THC, CBD, CBC, CBN, delta-8-THC, and CBG. Some samples may require analysis for THC acids A and B. Disposal of all waste materials is inclusive to this task.

c. Reanalyze samples of crops from previous years to determine viability of samples. Generally, this will require one analysis per batch or storage container per year. Disposal of all waste materials is inclusive to this task.

2. Extract cannabis to produce approximately 1 Kg of cGMP-grade marijuana extract of known CBD and THC contents as required by the COR.

If additional cannabis and cannabis extract are required beyond 10 Kg and 1 Kg limits respectively, the Contractor shall grow additional cannabis and produce additional cannabis extract (10 Kg, 50 Kg, and/or 100 Kg) upon the exercise of respective Option Quantities 1 and 2. Disposal of all waste materials is inclusive to this task.

The Contractor shall quantitatively analyze samples of cannabis extract for determining the THC, CBD and other cannabinoids contents, and upon NIDA authorization supply cannabis extract of known potency and specifications to the NIDA Drug Supply inventory.

3. Extract cannabis to isolate cGMP-grade/research grade (>95%) delta-9-THC and other cannabinoids, such as CBD, CBN, CBG, CBC, tetrahydrocannabivarin (THCV), and additional cannabinoids as required by the COR.

The Contractor shall manufacture, and provide the following cannabinoids to the NIDA drug supply inventory upon COR authorization, and dispose of the resulting waste materials per year:

a. delta-9-THC - 200.00 grams (g)

b. CBD - 4.00 g

c. CBN - 2.00 g

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d. CBG, CBC, and THCV - 0.200 g, each

4. Maintain the minimum stock of marijuana cigarettes (100 canisters of each strength, approximately 300 cigarettes per canister) for use in research. The Contractor must maintain all stock items on a first-in, first-out (FIFO) inventory system, unless otherwise designated by the COR. If at any time during the course of this contract the Contractor receives a request that would cause the stock to fall below the requisite minimum (100 canisters or less), the Contractor must notify the COR. The Contractor shall also:

a. Develop and manufacture standardized marijuana cigarettes within a range of specified delta-9-THC, or CBD, or both delta-9-THC and CBD contents and placebo upon the exercise of Option Quantity 4 as required by NIDA.

b. Prepare, preferably by hand-rolling, a small batch of marijuana cigarettes containing varying concentrations of THC or CBD or both as required by NIDA. For proposal purposes, please assume production of 5,000 standardized marijuana cigarettes containing a high concentration of delta-9-THC, or CBD or both (greater than 5.0%) or as required by the COR upon exercise of Option Quantity 4. More specifically, the Contractor shall:

i. Ascertain strength of inventoried marijuana cigarettes by their periodic analysis at three-month intervals or as required by the COR and update its analytical data sheets.

ii. Carry out stability analyses on inventoried marijuana cigarettes at various time period and temperature, or as directed by the COR.

iii. Perform quality control testing of newly and previously manufactured marijuana cigarettes on a regular basis to maintain their integrity.

iv. Ship marijuana cigarettes to research investigators as required by NIDA. The Contractor shall enclose analytical data sheets with each shipment or as specified by the COR.

v. Maintain a secure and video-monitored quality control shipping facility while having an expertise in handling and shipping of marijuana and marijuana cigarettes.

vi. Maintain supply and shipment records of all shipments on NIDA Drug Inventory Supply Control System (DISCS), a NIDA database.

Note: NIDA maintains this extensive inventory and shipment tracking system on an ORACLE Database system with Visual Basic on NIDA's Local Area Network. The Contractor must monitor exact quantities on-hand, adjust inventory of new compounds, re-purifications, and reductions in amount following shipment, produce shipping documents, and provide tracking of shipping orders at the Contractor's site. Employees of the Contractor who will have access to DISCS will be required to take requisite security-related trainings and meet security clearance requirements.

5. Provide an adequate DEA approved storage facility and store cannabis, cannabis extract, cannabis (marijuana) cigarettes, and isolated pure cannabinoids at an optimal temperature. More specifically, the Contractor shall:

a. Store available marijuana bulk plant materials including previous crops, marijuana cigarettes, and marijuana extracts in appropriate containers at 75ºF or at a suitable temperature to minimize chemical degradation for low THC, high THC, low CBD, high CBD, and equal THC and CBD containing materials. The Contractor shall maintain a minimum stock of 250 Kg of bulk plant materials and have storage capacity of approximately 700 Kg of such materials.

b. Store and keep records of all materials in accordance with the current DEA requirements. Local DEA agents will determine the exact type of security required. The Contractor shall store cannabis in a secure room(s) reserved for that purpose, and specially equipped to provide necessary security.

c. Maintain a database system containing all pertinent analytical data on individual sample analyses.

6. Carry out stability analyses at three month intervals, or as directed by the COR, on bulk materials (harvested and stored cannabis), marijuana cigarettes, cannabis extracts, and isolated cannabinoids including THC, CBD, and other cannabinoids to assure purity and strength.

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7. Employ the NIDA Drug Inventory Supply Control System (DISCS) database for supply and shipment records of cannabis, cannabinoids, cigarettes, and any other preparations of cannabis that are shipped by the Contractor.

8. Prepare and submit monthly progress reports to the COR on all activities in the project including preparation, analysis, and shipping of marijuana, marijuana cigarettes, marijuana extracts, and related products.

9. Prepare a new document or a document as an addendum to the NIDA Drug Master File (DMF) on marijuana and marijuana cigarettes for submission to the FDA when required by the COR, or after growing, harvesting, analyzing, and obtaining appropriate information and relevant data on new batches of cannabis, cGMP-grade cannabis extract, THC and CBD produced, and newly manufactured marijuana cigarettes.

10. Upon NIDA authorization, dispose of contaminated and/or unusable cannabis plant materials, marijuana cigarettes, or any other cannabis materials in accordance with appropriate DEA regulations.

11. Perform analysis of confiscated marijuana samples upon exercise of Option Quantity 6.

12. Perform the following phase-in requirements (Note: This task will be performed only if an organization other than the incumbent contractor receives the follow-on award):

Receive current inventory of cannabis, marijuana cigarettes, and any cannabinoids available under the previous contract in various quantities for immediate storage.

Note: NIDA will cover shipping costs for its inventory items and equipment, if any, to the Contractor's location. Arrangements for a site visit to the existing facilities for the new Contractor shall be arranged by the prior contractor.

C. Option Period 1 (Contract Year 2) Through Option Period 4 (Contract Year 5):

The Government reserves the right to exercise Option Periods 1, 2, 3, and 4 to extend the contract for an additional year at the end of each Contract Year if there is a continued need for the services performed and if the Contractor's performance has been satisfactory. The services provided by the Contractor in Option Period 1, Contract Year 2 through Option Period 4, Contract Year 5 of the contract, if exercised, shall be identical to the services described in the Base Period, Contract Year 1. The Government will evaluate the progress of this contract three months before the end of each Contract Year and decide within 30 days whether to exercise the next Option Year.

D. Option Quantities:

Option Quantity 1 - Cultivation of Cannabis:

Upon exercise of this Option Quantity (1a., 1b., or 1c.), respectively, the Contractor shall cultivate, grow, harvest, analyze, and store research grade cannabis, as specified in detail under the Statement of Work (SOW) in one of the following amounts as required by NIDA:

Option Quantity 1a: 1.5 acres (may be exercised a maximum of two times per Contract Year) Option Quantity 1b: 6.5 acres (may be exercised a maximum of one time per Contract Year) Option Quantity 1c: 12 acres (may be exercised a maximum of one time per Contract Year)

NIDA may exercise individual Option Quantities as and when warranted during the period of performance of the contract up to the maximum quantities indicated above, not to exceed 12 acres of cultivation per Contract Year. NIDA shall provide notification of intent to exercise an Option Quantity under the SOW to the Contractor on or before March 15 of the year in which the Option Quantity is to be exercised.

For proposal purposes, please assume that Option Quantities 1a, 1b, and 1c will each be exercised one time per Contract Year.

Option Quantity 2 - Production of Cannabis Extract:

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Upon exercise of this Option Quantity (2a., 2b., or 2c.), respectively, the Contractor shall extract cannabis and produce cGMP-grade cannabis extract (high CBD, low THC; high THC, low CBD; and equal ratio of CBD and THC), or as required by the COR and perform all necessary testing as described elsewhere in the SOW.

The Contractor shall prepare the extracts in one of the following amounts as required by NIDA:

Option Quantity 2a: 10 Kg (may be exercised a maximum of four times per Contract Year) Option Quantity 2b: 50 Kg (may be exercised a maximum of one time per Contract Year) Option Quantity 2c: 100 Kg (may be exercised a maximum of one time per Contract Year)

NIDA may exercise individual Option Quantities as and when warranted during the period of performance of the contract up to the maximum quantities indicated above.

For proposal purposes, please assume that Option Quantities 2a, 2b, and 2c will each be exercised one time per Contract Year.

Option Quantity 3 - Development and cGMP Manufacturing of Cannabis Extract Formulation Dosage Form:

Upon exercise of this Option Quantity, the Contractor shall:

1. Develop timelines, including milestones, and related budgets for the pre-formulation and formulation studies, including analytical and validation methods to be used in the formulation development, stability analyses, and manufacturing processes for bulk production of specified quantities of acceptable drug dosage form of cannabis extract of known cannabinoid strengths (THC and CBD).

2. Develop a formulation for CBD-rich extract to contain specific level(s) of CBD and THC in consultation with NIDA, a scientific advisory panel, and FDA under cGMP regulations. The Contractor shall also establish and update if needed a new NIDA Drug Master File on this drug dosage form to support Investigational New Drug (IND) research.

Work to be conducted by the Contractor will include the following: (1) validation of drug dosage form formulation process; (2) development and validation of analytical methods for determination of cannabinoids contents of new drug dosage form, particularly CBD and THC contents, and (3) conducting stability analyses on this formulation at various temperatures, such as room temperature, refrigerator and freezer temperatures for at least six months, and maintaining stability samples for continued monitoring for 2 years.

3. Manufacture, analyze, store, and distribute drug dosage form of cannabis extract of known cannabinoid strength for clinical and non-clinical research as authorized by the COR. The manufacturing of two (2) batches of this drug dosage form and its placebo will be authorized under cGMP regulations. The typical batch size should be 10,000 units of, capsules/ampoules/or any other developed drug dosage form of various specified THC and CBD contents and/or ratio, unless otherwise specified by the COR. The batches may differ in cannabinoid content and/or ratio of THC and CBD as determined by NIDA.

NIDA may exercise this Option Quantity as and when warranted during the period of performance of this contract up to a maximum of three times per Contract Year.

For proposal purposes, please assume that: 1) Option Quantity 3 will be exercised one time per Contract Year; and 2) the manufacturing batch size should be 10,000 units of drug dosage form and 10,000 units of its placebo.

Option Quantity 4 - Manufacturing of Cannabis (Marijuana) Cigarettes:

Upon exercise of this Option Quantity (4a., 4b., or 4c.), the Contractor shall manufacture cGMP-grade cannabis cigarettes, ascertain physical and chemical specifications, check purity and any other required specifications, create data sheets, and store and distribute the cigarettes upon NIDA authorization as described elsewhere in the SOW.

The Contractor shall manufacture the cigarettes in the following amounts and specifications as required by NIDA:

Option Quantity 4a: (may be exercised a maximum of five times per Contract Year) 25,000 Standardized marijuana cigarettes, THC content as specified by the COR.

Option Quantity 4b: (may be exercised a maximum of five times per Contract Year)

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25,000 Standardized marijuana cigarettes, CBD content as specified by the COR.

Option Quantity 4c: (Note: The Contractor may manufacture these cigarettes by hand-rolling) (may be exercised a maximum of three times per Contract Year):

5,000 standardized marijuana cigarettes containing a high concentration of delta-9-THC, or CBD or both (greater than 5.0%) or as required by the COR.

NIDA may exercise individual Option Quantities as and when warranted during the period of performance of the contract up to the maximum quantities indicated above.

For proposal purposes, please assume that Option Quantities 4a, 4b, and 4c will each be exercised one time per Contract Year.

Option Quantity 5 - Training and Transitional Support:

Upon exercise of this Option Quantity, the Contractor shall provide up to three months of transitional support and training and devote up to 480 person hours as described below. This Option Quantity may be exercised only one time, in the event that a follow-on contract is awarded to an entity other than the incumbent Contractor.

The Contractor shall provide up to three months training and transitional support in the following areas:

1. Review and training on the existing database system containing all pertinent analytical data on individual sample analyses, drug supply, and inventory balance, as well as a copy of the system;

2. Appropriate training in marijuana farming, its analysis, overall security, and DEA regulations in order to ensure that all requirements can be met;

3. Arrangements for a site visit to the existing facilities for the new contractor (including travel expenses); and

4. Transfer of any Government property and training and developmental costs associated with specific analytical laboratory procedures required for the contract. To ensure continuity of services, the Government shall exercise this Option Quantity no later than three months prior to expiration of the contract. NIDA will cover the cost of shipments to the new contractor's location.

For proposal purposes, please assume that Option Quantity 5 will be exercised one time in the final Contract Year.

Option Quantity 6 - Analysis of Confiscated Marijuana Samples:

Upon exercise of this Option Quantity, the Contractor shall perform analysis of confiscated marijuana samples submitted by the DEA, other law enforcement agencies, and/or by others as required by NIDA. Samples shall come from domestic and non-domestic seizures of marijuana, hashish and hash oil. The Contractor shall send results of analysis in writing and/or electronically to the submitting source(s) within a month of receipt of the samples for analysis. The Contractor shall provide quarterly reports in writing and/or electronically to other requesting agencies or parties upon COR authorization. The analyses on these samples generally will consist of same cannabinoids as for the harvested material. The Contractor shall analyze up to 150 samples per month for various cannabinoids. Disposal of all waste materials is inclusive to this task.

NIDA may exercise this Option Quantity as and when warranted during the period of performance of the contract up to a maximum of five times per Contract Year.

For proposal purposes, please assume that Option Quantity 6 will be exercised one time per Contract Year.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, hardcopies shall be submitted to the Contracting Officer's Representative (COR) and Contracting Officer (CO) as required in Article F.2.

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

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).

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. The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s), 1-2 hard copies of these reports will be required as follows:

1. Monthly Reports: This report shall present a description of all activities during the month, any problems encountered and problems solved, activities planned for the ensuing period, a list of current inventory of cannabis and cannabinoids produced and their supply as authorized by the COR, and any other relevant communication with the COR. The Contractor shall submit one hard copy and one electronic copy of the report to the COR within 5 calendar days after the end of each month. A monthly report shall not be required when either a semi-annual, annual, or the final report is due.

2. Semi-Annual Reports: This report shall present a summation of previously submitted monthly reports within the previous six months of performance. The Contractor shall submit one hard copy and one electronic copy of the report to the COR within 15 calendar days following the end of each 6-month reporting period. A semi-annual report shall not be required when either an annual or the final report is due.

3. Annual Report(s) (if Option Period(s) are exercised): This report shall present a summation of activities during the entire Contract Year. The Contractor shall submit one hard copy, one copy on compact disk (CD), and one electronic copy of the report to the COR and one hard copy to the CO within 15 calendar days following the end of each 12-month reporting period. An annual report shall not be required when the final report is due.

4. Final Report: This report shall include a summation of work performed and the results obtained during the entire contract period. The report shall be comprehensive and describe results achieved in detail. A monthly, semi-annual, or annual report shall not be required when the final report is due. The Contractor shall submit one hard copy, one copy on CD, and one electronic copy to the COR and one hard copy to the CO on or before the expiration date of the contract.

5. Quarterly Report on Potency Monitoring (if Option Quantity 5 is exercised) : If authorized by NIDA through the exercise of Option Quantity 5, the Contractor shall submit a quarterly marijuana potency monitoring report on the analysis of domestic and non-domestic confiscated samples. The Contractor shall submit one hard copy and one electronic copy to the COR within 15 calendar days following the end of each 3-month reporting period. This report may be supplied to others upon COR authorization.

2. Summary of Salient Results http://www.hhs.gov/web/508/index.html

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The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

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, or host 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 of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.)

e. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.3.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Contractor - Employee Non-Disclosure Agreement(s) The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

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(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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 Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, 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 first annual utilization report shall be due on or before March 15, 2016. Thereafter, reports shall be due annually on the contract anniversary date (if Option Period(s) are exercised). 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:

Contracting Officer NIDA R&D Contracts Management Branch National Institute on Drug Abuse/NIH 6001 Executive Boulevard, Room 4211 - MSC 9559 Bethesda, Maryland 20892- 9559

*Note: For delivery service or hand delivery, use: Rockville, MD 20852.

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

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SECTION D - PACKAGING, MARKING AND SHIPPING

1. 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.

2. All items shall be preserved, packaged, and marked to meet the requirements for controlled substances per the requirements of the Drug Enforcement Admininistration (DEA) and the packing requirements of the carrier, including that which may be necessary to prevent deterioration and damages to items due to the hazards of weather, shipping, handling, and storing. The Contractor shall pack marijuana cigarettes with approximately 300 per canister. Labeling shall be suitable to meet Food and Drug Administration (FDA) requirements and shall follow the instructions from the Code of Federal Regulations (CFR) regarding such substances. Labeling shall be adequate to meet the requirements to support an Investigational New Drug (IND). The quantity shall be determined after a recipient's request has been received. The labeling shall conform to FDA and CFR requirements and be adequate to meet the requirements to support an IND.

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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 Contracting Officer's Representative (COR), as specified in Section G, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse National…