Availability of Modular Cooperative Research and Development Agreement (CRADA)

DEPARTMENT OF ENERGY

Availability of Modular Cooperative Research and Development

Agreement (CRADA)

AGENCY: Office of Technology Utilization, Office of Laboratory

Management, Department of Energy.

ACTION: Notice of availability and opportunity for public comment.

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SUMMARY: This notice announces the availability of the Department of

Energy Modular Cooperative Research and Development Agreement (CRADA).

The Modular CRADA is a compendium of provisions which will be used for

preparing CRADAs between Department of Energy laboratories and non-

Federal Participants. The modular CRADA reflects input from

headquarters, Operations Office and Laboratory elements. It also

reflects extensive formal and informal technology transfer partner

feedback as well as the Department's experience of over 600 CRADAs. It

contains the basis and rationale for the language used, as well as pre-

approved options and guidance for use of the language. The modular

CRADA includes several other important features distinguishing it from

previous Department of Energy model CRADAs: (1) It does not require as

much oversight by Departmental headquarters, does not have as much

required language; (2) it provides more options in certain areas, such

as product liability; and (3) it more fully communicates the

Department's rationale for its CRADA language. The modular CRADA is

expected to be periodically reviewed and revised as part of the

Department of Energy's continuous improvement process. Comments from

the public are encouraged.

ADDRESSES: A copy of the modular CRADA is available for inspection and

reproduction at the public reading room of the U.S. Department of

Energy, Forrestal Building, 1000 Independence Avenue, SW, Washington,

DC. The public reading room is open from 10 a.m. to 4 p.m.; you may

contact reading room staff at (202) 586-6020. If you want a copy of the

modular CRADA mailed to you directly, please contact the U.S.

Department of Energy at the address below. Comments on the modular

CRADA are welcome and may be sent to the address below.

FOR FURTHER INFORMATION OR TO COMMENT CONTACT: U.S. Department of

Energy, PA-5, 1000 Independence Avenue, SW., Washington, DC 20585,

Phone: 202-586-5575, Fax: 202-586-7303.

SUPPLEMENTARY INFORMATION: An overview and the table of contents of the

modular CRADA are attached.

Issued at Washington, DC, on February 4, 1994.

Antionette Grayson Joseph,

Acting Director, Office of Laboratory Management.

The Modular CRADA

Introduction

This document, to be referred to as the Department of Energy (DOE)

Modular Cooperative Research and Development Agreement (CRADA), is a

compendium of provisions which may be drawn upon for crafting CRADAs.

It has been developed to be responsive to the needs of different CRADA

Participants while protecting the interests of the Government and the

U.S. taxpayers and is a tool for DOE and its Government-Owned

Contractor-Operated (GOCO) laboratories, hereafter referred to as

laboratories, to facilitate the negotiation, development and timely

approval of CRADAs.

This Modular CRADA incorporates three types of provisions:

(1) Those few that are required by statute or policy, [set off by

double underscore] are strongly recommended for timely approval, and

can only be changed with DOE Headquarters approval. Changing double

underscored language or examples may delay the process. Double

underscored language can be eliminated where it doesn't apply, such as,

for example the deletion of the definition of ``Subject Invention''

where it is not anticipated that there will be any subject inventions

under the CRADA.

(2) Those that sound judgment suggests have a valid basis for being

included in the terms and conditions of the CRADA, consistent with the

guidelines incorporated herein. These can be modified in one of three

ways:

--By using the pre-approved options provided in the guidance;

--By modifying the language without changing its substantive meaning;

and

--By negotiating the language that changes its substantive meaning, or

even deleting the language with appropriate justification; in each of

these two instances, operations office approval is required.

(3) Those that are left solely to the negotiations between the

laboratory and the Participants. [Shown in brackets.]

Through a spirit of teamwork and a policy of ``no surprises,'' this

document should enable DOE and its laboratories to be responsive to a

broad range of Participant needs. This approach is intended to convey

the maximum flexibility in CRADA development, and in speed of

negotiations and approval, while fostering consistency across DOE and

its laboratories.

In drafting a CRADA from the options provided in the Modular CRADA,

the laboratory should be careful not to create internal conflicts

within the agreement. The draft CRADA should still follow the form

(i.e., order of provisions) of the DOE Modular CRADA in order to

facilitate operations office review and approval.

In this document, the format for presenting the various provisions

of the CRADA will consist of:

--A statement of the article, with language required by statute or

policy double underscored;

--A rationale for the article; and

--Pre-approved optional provisions for the article (set off inside a

box).

Example: Article 1 (Title)

--Required provisions (if any)

--Rationale or basis for requirement

--Pre-approved optional provisions (if any)

--Rationale/appropriate circumstances

--Pre-approved optional provisions #2

--Rationale/appropriate circumstances

--Bracketed provisions

--Rationale/explanation

--General Guidance

The Sample CRADA

A sample DOE CRADA, which is attached, incorporates the double

underscore provisions and some of the more common optional provisions

provided in the Modular CRADA. It is a tool for communicating DOE's

general requirements and expectations to potential Participants in a

clear and consistent manner. The sample DOE CRADA should be provided to

potential Participants as the first hand-out in all instances, such as

at conferences and trade shows and DOE sponsored events. When the

sample DOE CRADA is used for these purposes, it may be modified only to

the extent that the laboratory name is inserted.

Negotiating and Approving CRADAs

By law and through prime contract provisions, the laboratories have

been delegated the authority and responsibility for negotiating the

CRADA, including a Statement of Work. In exercising that authority,

laboratories need to strike a balance between consistency and

flexibility.

To the extent the negotiated CRADA uses language that does not

deviate from the double underlined provisions and uses the pre-approved

optional provisions, the Operations Office review and approval of the

CRADA will be faster.

The Operations Offices are the approval authority for Joint Work

Statements (JWSs) and CRADAs. To facilitate Operations Office review,

laboratories should identify all deviations from the double underlined

provisions or pre-approved optional provisions at the time the CRADA is

submitted for approval. It is recommended that two proposed CRADA

versions be submitted by the laboratories to the Operations Offices--

one which highlights all deviations from the Modular CRADA provisions

using ``redline'' and ``strikeout'' features and one which is a

``clean'' version. All deviations which are considered by the

laboratories to be substantive should be supported by appropriate

justification. Any deviation from the double underlined provisions

requires approval of DOE Headquarters. After receiving any proposed

deviations to double underscored language from a laboratory, the

Operations Office will transmit the language and reasons for the

requested deviation to the Director of the Office of Technology

Utilization (LM-20) in Headquarters, who will confer with the

appropriate elements in Headquarters in determining if the requested

deviation is acceptable and inform the Operations Office of the

Headquarters' determination. Any deviations from the pre-approved

optional provisions, except for deviations to double underscored

language which must be approved by Headquarters, requires review and

approval by the Operations Office. In the case of changes from the pre-

approved optional provisions which the Operations Office agrees are

non-substantive, such approval may be reflected merely by approval of

the CRADA. In the case of substantive changes, specific approval in the

form of a notation on the ``redline'' version, or other supporting

documents, will suffice. Any requests for modification of the CRADA by

the Operations Office to the laboratory must comply with the

requirements of 15 U.S.C. 3710a(c)(5)(C).

While available for consultation to both the laboratory and the

prospective Participant, the Operations Office should refrain from

becoming a third party to the negotiations. Each Operations Office is

encouraged to designate a single point of contact to facilitate the

CRADA review and approval process at the Operations Office. Like the

Operations Offices, Program offices and others should refrain from

becoming a third party to the negotiations between the laboratory and

the prospective Participant.

The Importance of Teamwork and Communication

In order to use this document effectively, close cooperation and

communication between the laboratory and DOE is essential. Issues that

can be foreseen as key issues, especially critical departures from pre-

approved language, should be discussed as early as possible. There

should be a minimum of surprises in the process. At the same time, the

laboratory and DOE should be open to proposed changes from Participants

where the changes help the process of negotiation but do not infringe

upon the Government's rights. When alternative language is clearly

called for, such alternative language should be used. One of the

objectives of this document is to provide pre-approved alternative

language for different situations, as well as guidance and rationale

for using that alternative language.

The DOE Modular CRADA will be updated on a routine basis to

incorporate new language and alternatives, based on input from the

Participants, laboratories, Operations Offices, and DOE programs.

Laboratory staff with proposed updates should contact their Operations

Office, and Operations Office staff with proposed updates should

contact the DOE Office of Technology Utilization.

The following points should be addressed in a CRADA as minimum

guidance for an effective CRADA. The attached DOE Sample CRADA is the

basic set of CRADA provisions; other clauses are provided in the

Guidance to accommodate different arrangements between Contractors and

Participants. Many of the specific articles and clauses are negotiable

between the Parties.

Table of Contents

Introduction to the DOE Modular CRADA, The DOE Sample CRADA,

Negotiating and Approving CRADAs, The Importance of Teamwork and

Communications.

DOE-Approved CRADA Language and Guidance

Title of CRADA

Article I: Definitions

Article II: Statement of Work

Article III: Funding and Costs

Article IV: Personal Property

Article V: Disclaimer

Article VI: Product Liability

Article VII: Obligations as to Proprietary Information

Article VIII: Obligations as to Protected CRADA Information

Article IX: Rights in Generated Information

Article X: Export Control

Article XI: Reports and Abstracts

Article XII: Pre-Publication Review

Article XIII: Copyrights

Article XIV: Reporting Inventions

Article XV: Title to Inventions

Article XVI: Filing Patent Applications

Article XVII: Trademarks

Article XVIII: Mask Works

Article XIX: Cost of Intellectual Property Protection

Article XX: Reports of Invention Use

Article XXI: DOE March-in Rights

Article XXII: U.S. Competitiveness

Article XXIII: Assignment of Personnel

Article XXIV: Force Majeure

Article XXV: Administration of the CRADA

Article XXVI: Records and Accounting for Government Property

Article XXVII: Notices

Article XXVIII: Disputes

Article XXIX: Entire CRADA and Modifications

Article XXX: Termination

Article ____: Project Management

Article ____: Order of Precedence

Article ____: Waiver

Documents Section:

Document A: Procedure for Foreign Ownership, Control and Influence

review

Document B: U.S. Competitiveness Work Sheet

Document C: Format for Expanded Software Abstract

Document D: The DOE Sample CRADA

[FR Doc. 94-3780 Filed 2-17-94; 8:45 am]

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