Indiana_Redacted-J A-(JOFOC)-Posted-w-ATTACH-1-SOW.pdf

Attachment 1

STATEMENT OF WORK

PRECLINICAL MEDICATIONS SCREENING IN GENETIC MODELS OF ALCOHOLISM

I. BACKGROUND and INTRODUCTION

This contract is to address the present and anticipated future needs of NIAAA’s Medication Development Program of the Division of Neuroscience and Behavior’s Preclinical Medication Efficacy Testing Program. This replacement contract will continue the blind testing of reference compounds and proprietary compounds in P rats and HAD1 rats selectively bred for alcohol preference. The contract will use mechanisms having intellectual property conditions favorable to compound providers. This will eliminate a major barrier to testing optimized compounds having preclinical as well as clinical toxicology data and will stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for alcoholism. The statement of work requirements are considered to be severable.

II. OBJECTIVES

To assess effects of proprietary compounds in standardized models of alcohol intake in two (2) rat lines selectively bred for alcohol dependence.

To collect, analyze and display data from these tests and report them to designated NIAAA personnel. The data generated by this contract will be used in the identification of compounds for further development.

III. SERVICES TO BE PERFORMED

A. GENERAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall 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 below. Specifically, the Contractor shall perform the following:

B. TECHNICAL REQUIREMENTS

1. Compound Testing

On the basis of information provided by NIAAA, the Contractor shall test effects of compounds submitted to them by NIAAA staff members in voluntary limited-access 2 bottle choice drinking paradigms using alcohol-preferring P rats and HAD1 rats. If requested by NIAAA, contractor shall purchase reference compounds for testing. All details of experimental protocols shall be subject to the concurrence of the NIAAA Project Officer. Minimally, testing protocols should conform to the following standards: a) Justification of sample size, including power calculation; b) blind testing; and c) random or stratified assignment of subjects to experimental conditions. The Contractor may be asked to evaluate whether the interventional drug reached and engaged the intended target when possible. It is anticipated that 6-8 compounds will be tested annually under the contract.

2. Compound Storage and Administration

The Contractor shall store compounds supplied to them by NIAAA such that they cannot be readily accessed by personnel outside the Principle Investigator’s laboratory. Adequate storage conditions, including -70 C freezers when noted, shall be available on site. The Contractor shall be responsible for providing all necessary reagents and supplies necessary for administering test medications according to instructions supplied by NIAAA.

3. Ongoing Paradigm Validation

The Contractor shall further validate voluntary limited-access 2 bottle choice drinking paradigms and addition alcohol consumption, reinforcement and reward paradigms as requested by NIAAA. This may include periodic tests with reference compounds designated by the NIAAA Contracting Officer’s Representative (COR). These tests will be performed and reported upon completion.

4. Data Analysis and Reporting

The Contractor shall perform appropriate statistical analysis of the data, and prepare a summary of the testing conditions and results including appropriate graphical displays. Reports shall also include interpretation of results written in language that can be understood by scientists not having specialized training in alcohol or addiction research. The report is to be submitted to the NIAAA COR, along with copies of raw data, if requested, 14 calendar days after the completion of the medication test.

5. Data Recording

Throughout the life of the contract, the Contractor shall maintain a binder of all experimental protocols. Protocols shall be written using a strong scientific standard, with all details of the experiment recorded in such a way that another lab could replicate the study exactly. The binder shall contain all protocols proposed and/or tested during the duration of the contract, and shall include notations with regard to their current status. A copy of any protocol shall be available to the NIAAA COR upon request.

6. Data Maintenance and Storage

The Contractor shall retain, for the duration of this contract, all laboratory notebooks (which shall include hard copies of raw data) and any electronic data files generated under this contract, as well as all coded proprietary test compounds received for evaluation under this contract. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and hard copies of raw data. On or before the expiration date of this contract, if so instructed by the NIAAA COR, the contractor shall ship these items to the

NIAAA COR. The contractor shall not enter data from studies unrelated to this contract in notebooks or on disks containing data generated under this contract.

7. General Technical Requirements

This contract involves the use of rats as test subjects. Therefore, the Contractor must have the appropriate knowledge and facilities capable of housing and caring for rats in a clean, safe, appropriate environment. Further the Contractor must follow those specific requirements regarding the use of rats in preclinical studies as stated in the various related clauses and Articles in this contract.

8. Special Contract Requirements

While the Contractor will be free to publish data developed under this contract on compounds and materials (Materials) that are specified by the COR as publicly available, most of the Material provided to the contractor will be proprietary to third parties. Data generated from testing and evaluation of these Materials will also be considered to be proprietary by the provider. Unless these data are protected, third parties are not likely to make their proprietary Materials available for testing and evaluation under the contract. Accordingly, the contractor must agree not to publish data regarding proprietary test Materials unless the COR obtains permission from the submitter.

Additionally, in order to encourage third parties to submit their proprietary Materials for evaluation and testing, the contractor must agree to offer the provider an option to an exclusive license to any contractor subject invention conceived or first actually reduced to practice using a provider’s proprietary Materials. This agreement is contained in Article H.21 entitled, “Intellectual Property Option to the Provider.”

9. PROJECT MANAGEMENT

A. Overall Project Management

Provide for the overall management, integration and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts.

Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation and timely completion of all projects carried out under this contract and effective communications with the COR and the Contracting Officer.

Provide for a Principal Investigator with responsibility for overall project management and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.

B. Contract Initiation Meeting

Within 30 calendar days after the contract award, the Contractor shall participate in a Contract Initiation Meeting with the COR, the Contracting Officer, and other NIAAA personnel designated by the COR. This will be held virtually via a phone or video conference. The purpose of this meeting is to acquaint all parties with the contract requirements, any special NIAAA procedures, and to allow NIAAA and contract personnel to become acquainted with one another and the contract requirements.

10. FINAL TRANSITION

Prior to the completion date of the contract’s Base (i.e. period-1) or the completion date of any option(s) exercised, the Contractor shall ensure an orderly, secure, and efficient transition of contract-related materials and activities to a designated successor contractor or to the Government. A description of transition activities, timelines, and assigned staff shall be provided in a Draft and Final Transition Plan, which will be reviewed and approved by the COR and the Contracting Officer. The Draft Transition Plan shall be submitted 45 calendar days prior to the completion date of the contract’s Base (i.e. period-1) or the completion date of any option(s) exercised, and the Final Transition Plan (also reviewed and approved by the COR and the Contracting Officer) shall be submitted 30 calendar days prior to the completion date of the contract’s Base (i.e. period-1) or the completion date of any option(s) exercised. The Plan shall include:

Status of any ongoing contract projects with anticipated completion dates, along with a timeline for completion of transition activities and the assigned staff;

Plan for transferring all contract-related electronic data to the NIAAA COR;

Plan for transferring all contract-related hardcopy data (i.e. experimental protocols binders, etc.

as described in the Data Analysis and Reporting and Data Recording elements of this statement of work) to the NIAAA COR;

Plan for final disposition of all contract Materials (i.e. Third Party Compounds and other

Materials kept in -70 C freezers and in other storage locations) to the NIAAA COR.

11. OPTIONS

In addition to the services outlined above for the contract’s Base (i.e. Period-1 e.g. September 29, 2014 to September 28, 2015), options for additional services may be exercised under the contract at the sole discretion of the Government. This statement of work prevails for the contract’s Base and for options 1 through 4 (i.e. periods 2, 3, 4, and 5). The options are as follows and each, like the Base, is considered severable:

Option-1 (i.e. Period-2) September 29, 2015 to September 28, 2016

Option-2 (i.e. Period-3) September 29, 2016 to September 28, 2017

Option-3 (i.e. Period-4) September 29, 2017 to September 28, 2018

Option-4 (i.e. Period-5) September 29, 2018 to September 28, 2019