Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Notices 12771

Time: 8:30 a.m.

Place: Hyatt Regency, Bethesda, Maryland.

Contact Person: Dr. Lynn Amende, 5333

Westbard Avenue, Room 5A10, Bethesda,

Maryland 20892, (301) 594–7480.

Purpose/Agenda: To review and evaluate

grant applications.

Name of SEP: Cytokine Effect on

Hematopoiesis in AIDS Animal Models.

Date: May 1–2, 1995.

Time: 7 p.m.

Place: Holiday Inn, Chevy Chase,

Maryland.

Contact Person: Dr. Deborah Beebe, 5333

Westbard Avenue, Room 555, Bethesda,

Maryland 20892, (301) 594–7418.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

sec. 552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health.)

Dated: March 3, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–5643 Filed 3–7–95; 8:45 am]

BILLING CODE 4140–01–M

Uniform Biological Material Transfer

Agreement: Discussion of Public

Comments Received; Publication of

the Final Format of the Agreement

AGENCY: National Institutes of Health

(NIH), Public Health Service (PHS),

DHHS.

ACTION: Notice.

SUMMARY: Following consideration of

public comments, the NIH, as

designated lead PHS agency for

technology transfer activities, is issuing

the final version of the Uniform

Biological Material Transfer Agreement

(‘‘UBMTA’’) to be used by participating

public and nonprofit organizations, an

implementing letter to memorialize

individual exchanges of biological

material under the UBMTA, and a

simple letter agreement for transferring

nonproprietary biological materials

among public and nonprofit

organizations. For-profit organizations

may also choose to adopt these

agreements as well. The PHS

recommends that the UBMTA be

considered for general use in the

exchange of biological material for

research purposes among public and

nonprofit entities.

FOR FURTHER INFORMATION CONTACT:

Carol C. Lavrich, Office of Technology

Transfer, National Institutes of Health,

6011 Executive Boulevard, Suite 325,

Rockville, MD 20852–3804, phone: 301–

496–7735 ext. 287, fax: 301–402–0220.

Background

Open access to the results of

federally-funded research is a

cornerstone of PHS’s research policy. In

the case of many research projects, this

includes not only access to information

provided through publications, but also

access to biological research materials

necessary to replicate or build on the

initial results. Frequently, the exchange

of research materials between scientists

in separate organizations involves caseby-case negotiation of material transfer

agreements (‘‘MTAs’’). In order to guide

and facilitate the increasing number of

such transfers, PHS issued in 1988, a

‘‘Policy Relating to Distribution of

Unique Research Resources Produced

with PHS Funding’’ (NIH Guide for

Grants and Contracts, Vol. 17, No. 29,

September 16, 1988: pg. 1; also

published at pp. 8–25–8–26 of the PHS

Grants Policy Statement, DHHS

Publication No. (OASH) 94–50,000

(Rev.) April 1, 1994. This was followed

in 1989 by adoption of a standard

Material Transfer Agreement form for

use by PHS scientists. MTAs are

important because they require the

recipient to exercise care in the

handling of the materials, to maintain

control over the distribution of the

materials, to acknowledge the provider

in publications, and to follow relevant

PHS guidelines relating to recombinant

DNA, protection of human subjects in

research, and the use of animals.

However, while most other

organizations have adopted some

standard material transfer agreement

form, they are not all consistent.

Issue

Several issues have affected the

sharing of research materials. These

include delays in sharing of materials

while conducting unnecessarily

extensive negotiations on individual

MTAs, required grants of invention

rights to improvements to the materials

or to inventions made using the

materials, and required approval for

publication. The negotiation of these

complex issues has resulted in

significant delays in sharing materials,

undue administrative barriers to

sharing, and in some cases, lack of

availability of materials for further

research by federal grantees. (For reports

and discussion of these issues, please

refer to The New Biologist, Vol. 2, No.

6, June 1990: pp 495–497; and Science,

Vol. 248, 25 May, 1990: pp 952–957).

Proposal

The PHS, in conjunction with

representatives of academia and

industry, has coordinated the

development of a proposed uniform

biological material transfer agreement

(‘‘UBMTA’’) to address concerns about

contractual obligations imposed by

some MTAs and to simplify the process

of sharing proprietary materials among

public and nonprofit organizations.

Since 1990, the Association of

University Technology Managers

(‘‘AUTM’’), and many individuals

representing universities, law firms, and

industry, have played leadership roles

in furthering the development of

common materials sharing practices.

The consistent use of the UBMTA by

public and nonprofit organizations

could reduce the administrative burden

of sharing materials as investigators

come to rely on common acceptance of

its terms by cooperating organizations.

The PHS recommends that the

UBMTA be considered for general use

in the exchange of materials for research

purposes among public and nonprofit

organizations. For-profit organizations

may also choose to adopt this agreement

as well. While use of the UBMTA may

not be appropriate for every material

transfer, if used for the majority of

transfers, it could set standards for

materials sharing that would be of longterm benefit to the research enterprise

and to the public health.

As a further suggestion to simplify the

process of materials sharing, it is

proposed that the UBMTA be approved

at the organizational level, and handled

in a master agreement or treaty format,

so that individual transfers could be

made with reference to the UBMTA,

without the need for separate

negotiation of an individual document

to cover each transfer. As a result,

transfers of biological materials would

be accomplished by an Implementing

Letter (see sample) containing a

description of the material and a

statement indicating that the material

was being transferred in accordance

with the terms of the UBMTA. The

Implementing Letter would be executed

by the provider scientist, the recipient

scientist, and any other authorized

official(s) of the provider or recipient

organization who might be required to

sign on behalf of the organization. Thus,

sharing of materials between

organizations, each of which had

executed the UBMTA, would be

significantly simplified. At the same

time, any organization would retain the
12772 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Notices

option to handle specific material with

unusual commercial or research value

on a customized basis. Thus, the use of

the UBMTA would not be mandatory,

even for signatory organizations.

Administration of the signatory process

also may be organization-specific. For

example, organizational policies may

require additional, or fewer, signatures.

For non-proprietary materials, a

Simple Letter Agreement also has been

developed, which incorporates many of

the same principles as the UBMTA. This

Simple Letter Agreement also could be

used where the organizations have not

agreed to the UBMTA.

On behalf of PHS, NIH published the

full text of the proposed version of the

UBMTA, the draft Implementing Letter,

and the draft Simple Letter Agreement

in the Federal Register on June 21,

1994, and invited public comment. NIH

received thirteen written comments

from universities, research

organizations, and various associations.

The primary concerns raised by

respondents and the NIH response to

these comments are described in the

comment section below.

Comments

The vast majority of the respondents

were extremely supportive of the

UBMTA concept as a means of

simplifying and expediting biological

material transfers among public and

nonprofit organizations. Several

respondents suggested that a

comparable agreement be developed for

transfers between for-profit and

nonprofit organizations. The PHS fully

supports this idea and recognizes the

importance of streamlining this type of

agreement with industry. The NIH, in

conjunction with the working group

listed above, developed a proposed

model for UBMTA transfers from

industry to nonprofit organizations

which was circulated to AUTM

membership on December 31, 1992.

This was an adaptation of the original

UBMTA format which grants the

industrial provider an option to

negotiate a license agreement to

inventions made through the use of the

provided material. It should be noted

that government agencies will not be

able to use this format unless a

Cooperative Research and Development

Agreement (‘‘CRADA’’) is negotiated

because of limitations in statutory

authority to provide licenses or options

to license intellectual property in other

types of agreements. No format was

ultimately created by the working group

for the transfer of material from

nonprofit organizations to industry

because it was viewed as being

essentially a license negotiation. Most

organizations have license agreement

formats for internal use of biological

materials by commercial organizations,

as well as for commercial sale of

biological materials. The PHS will be

soliciting further public commentary on

the proposed model for UBMTA

transfers from industry to nonprofit

organizations.

Several respondents indicated that

some of the UBMTA definitions were

confusing. As appropriate, clarifications

have been made. In particular, the

definition relating to ‘‘Modifications’’

has been refined so that it is clear that

Modifications are developed by the

Recipient and contain or incorporate the

Material. While the Modifications are

owned by the Recipient who can license

them for commercial use, this new use

also may require a second commercial

license or other evidence of agreement

from the Provider since the

Modifications incorporate the Material.

The UBMTA also acknowledges that

there may be other substances created

by the Recipient through the use of the

Material which are not Modifications,

Progeny, or Unmodified Derivatives of

the Material, and are owned by the

Recipient, who is free to license them.

The UBMTA does not provide for any

type of ‘‘reach-through’’ rights for the

Provider of the Material, i.e. property

rights in products developed by the

Recipient through the use of the

transferred material. Several definitions

of ‘‘nonprofit organization’’ were

proposed, and the final definition used

was taken directly from the

implementing regulations to the BayhDole Act (37 CFR Part 401). We have

also instituted a definition of

Commercial Purposes to provide a clear

distinction between academic research

and activities which are considered

commercial.

Other issues raised by respondents

fell into two areas: issues regarding

confidentiality with respect to

protection of intellectual property

rights, and issues regarding

organizational policy variance on

signature requirements from the

suggested UBMTA signature

requirements:

(1) Confidentiality Issues

Some respondents were concerned

that the requirement for the Provider to

provide the Recipient with specific

information regarding patent status of

the Material might impair an

organization’s ability to obtain patent

protection and questioned the necessity

for the Recipient to obtain such

information. The PHS agrees that the

provision of such information is not

necessary and would create an

additional administrative burden that

would be inconsistent with the primary

purpose of the UBMTA. We also agree

that any commercial use or improper

disclosure on the part of the Recipient

could impair the Provider’s ability to

obtain suitable patent protection.

Therefore, we have removed the

requirement for the Provider to inform

the Recipient about patent status and

have included a provision that the

Material may be the subject of a patent

application. However, the Recipient is

bound to inform the Provider upon

filing patent applications which claim

Modifications or method(s) of

manufacture or use(s) of the Material so

that the Provider may determine

whether it believes joint inventorship is

appropriate. The requirement to divulge

the Provider’s prior grant of rights to a

third party (other than the customary

rights granted to the federal

government), that would substantially

affect Recipient, has been eliminated

since the agreement specifies that this

transfer is for teaching and academic

research purposes and that the Provider

is under no obligation to widen the

rights granted.

(2) Signature Requirement Issues

Some respondents were concerned

that their organizational polices with

respect to signing MTAs are different

than those suggested in the UBMTA

Implementing Letter. An organization

may require an additional signature of

an authorized official of the Recipient

organization if the signatory scientist is

not legally authorized to bind the

organization. In this case, the legally

binding signature of the authorized

official of the Recipient organization

would provide assurance to the Provider

organization that the Recipient

organization is a signatory to the

UBMTA. This assurance is critical

because if the Recipient organization is

not a party to the UBMTA, it may not

be bound by the terms of the UBMTA.

The signatures of the scientists provide

a necessary record for both

organizations of the transfer of the

Material. Of course, organizations are

free to develop their own signatory

policies regarding the UBMTA.

We hope to get practical guidance and

constructive feedback from scientists

and technology transfer professionals as

they begin to use the UBMTA. It is

anticipated that the UBMTA will be a

‘‘living’’ document which will be

further refined and streamlined over

time. Many of the definitions were

intensively debated throughout the

course of drafting the UBMTA and it is

expected that they will be sharpened

over time through use. We attempted to
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Notices 12773

emphasize a fair allocation of rights

between the Provider and the Recipient

and had to draw lines especially in the

definitions of Modifications and

Commercial Purposes. The use of the

UBMTA over time will ultimately

determine whether the right decisions

were made.

The Association of University

Technology Managers (‘‘AUTM’’) will

be providing assistance in

implementation of the UBMTA among

its members and nonprofit organizations

by notifying members of its availability

in its newsletter, providing signature

copies of the agreement at its annual

meeting, assisting with training

regarding material transfers, and

maintaining a master list of signatories

to the UBMTA. We anticipate that the

master list of signatories will be

published in the Federal Register

annually. In order for AUTM to compile

a master list of signatories, organizations

should return an executed copy of the

UBMTA Master Agreement to: The

UBMTA Project, AUTM Headquarters,

71 East Avenue, Suite S, Norwalk, CT

06851–4903. A read only version of the

signatory list will be made available on

the Internet. A copy of this

announcement also will be appearing in

the NIH Guide For Grants and Contracts.

Complete texts of the final version of

the UBMTA, the Implementing Letter,

and the Simple Letter Agreement follow

in the Appendix.

Dated: February 18, 1995.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

Appendix—Master Agreement

Regarding Use of the Uniform

Biological Material Transfer Agreement

March 8, 1995

Upon execution of an Implementing

Letter in the form attached which

specifies the materials to be transferred,

this organization agrees to be bound by

the terms of the attached Uniform

Biological Material Transfer Agreement

(‘‘UBMTA’’) published in the Federal

Register on March 8, 1995.

Attachments:

UBMTA

Implementing Letter

Organization: llllllllllllll

Address: llllllllllllllll

Authorized Official: lllllllllll

Title: llllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

Please return an executed copy of this

Master Agreement to: The UBMTA

Project, Association of University

Technology Managers (AUTM), 71 East

Avenue, Suite S, Norwalk, CT 06851–

4903. AUTM will be maintaining signed

originals and the official list of signatory

organizations.

The Uniform Biological Material

Transfer Agreement

March 8, 1995

I. Definitions:

1. PROVIDER: Organization providing

the ORIGINAL MATERIAL. The name

and address of this party will be

specified in an implementing letter.

2. PROVIDER SCIENTIST: The name

and address of this party will be

specified in an implementing letter.

3. RECIPIENT: Organization receiving

the ORIGINAL MATERIAL. The name

and address of this party will be

specified in an implementing letter.

4. RECIPIENT SCIENTIST: The name

and address of this party will be

specified in an implementing letter.

5. ORIGINAL MATERIAL: The

description of the material being

transferred will be specified in an

implementing letter.

6. MATERIAL: ORIGINAL

MATERIAL, PROGENY, and

UNMODIFIED DERIVATIVES. The

MATERIAL shall not include: (a)

MODIFICATIONS, or (b) other

substances created by the RECIPIENT

through the use of the MATERIAL

which are not MODIFICATIONS,

PROGENY, or UNMODIFIED

DERIVATIVES.

7. PROGENY: Unmodified descendant

from the MATERIAL, such as virus from

virus, cell from cell, or organism from

organism.

8. UNMODIFIED DERIVATIVES:

Substances created by the RECIPIENT

which constitute an unmodified

functional subunit or product expressed

by the ORIGINAL MATERIAL. Some

examples include: subclones of

unmodified cell lines, purified or

fractionated subsets of the ORIGINAL

MATERIAL, proteins expressed by

DNA/RNA supplied by the PROVIDER,

or monoclonal antibodies secreted by a

hybridoma cell line.

9. MODIFICATIONS: Substances

created by the RECIPIENT which

contain/incorporate the MATERIAL.

10. COMMERCIAL PURPOSES: The

sale, lease, license, or other transfer of

the MATERIAL or MODIFICATIONS to

a for-profit organization. COMMERCIAL

PURPOSES shall also include uses of

the MATERIAL or MODIFICATIONS by

any organization, including RECIPIENT,

to perform contract research, to screen

compound libraries, to produce or

manufacture products for general sale,

or to conduct research activities that

result in any sale, lease, license, or

transfer of the MATERIAL or

MODIFICATIONS to a for-profit

organization. However, industrially

sponsored academic research shall not

be considered a use of the MATERIAL

or MODIFICATIONS for COMMERCIAL

PURPOSES per se, unless any of the

above conditions of this definition are

met.

11. NONPROFIT ORGANIZATION(S):

A university or other institution of

higher education or an organization of

the type described in section 501(c)(3)

of the Internal Revenue Code of 1954

(26 U.S.C. 501(c)) and exempt from

taxation under section 501(a) of the

Internal Revenue Code (26 U.S.C.

501(a)) or any nonprofit scientific or

educational organization qualified

under a state nonprofit organization

statute. As used herein, the term also

includes government agencies.

II. Terms and Conditions of this

Agreement

1. The PROVIDER retains ownership

of the MATERIAL, including any

MATERIAL contained or incorporated

in MODIFICATIONS.

2. The RECIPIENT retains ownership

of: (a) MODIFICATIONS (except that,

the PROVIDER retains ownership rights

to the MATERIAL included therein),

and (b) those substances created through

the use of the MATERIAL or

MODIFICATIONS, but which are not

PROGENY, UNMODIFIED

DERIVATIVES or MODIFICATIONS

(i.e., do not contain the ORIGINAL

MATERIAL, PROGENY, UNMODIFIED

DERIVATIVES). If either 2 (a) or 2 (b)

results from the collaborative efforts of

the PROVIDER and the RECIPIENT,

joint ownership may be negotiated.

3. The RECIPIENT and the

RECIPIENT SCIENTIST agree that the

MATERIAL:

(a) is to be used solely for teaching

and academic research purposes;

(b) will not be used in human

subjects, in clinical trials, or for

diagnostic purposes involving human

subjects without the written consent of

the PROVIDER;

(c) is to be used only at the

RECIPIENT organization and only in the

RECIPIENT SCIENTIST’s laboratory

under the direction of the RECIPIENT

SCIENTIST or others working under

his/her direct supervision; and

(d) will not be transferred to anyone

else within the RECIPIENT organization

without the prior written consent of the

PROVIDER.

4. The RECIPIENT and the

RECIPIENT SCIENTIST agree to refer to

the PROVIDER any request for the

MATERIAL from anyone other than

those persons working under the
12774 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Notices

RECIPIENT SCIENTIST’s direct

supervision. To the extent supplies are

available, the PROVIDER or the

PROVIDER SCIENTIST agrees to make

the MATERIAL available, under a

separate implementing letter to this

Agreement or other agreement having

terms consistent with the terms of this

Agreement, to other scientists (at least

those at NONPROFIT

ORGANIZATION(S)) who wish to

replicate the RECIPIENT SCIENTIST’s

research; provided that such other

scientists reimburse the PROVIDER for

any costs relating to the preparation and

distribution of the MATERIAL.

5. (a) The RECIPIENT and/or the

RECIPIENT SCIENTIST shall have the

right, without restriction, to distribute

substances created by the RECIPIENT

through the use of the ORIGINAL

MATERIAL only if those substances are

not PROGENY, UNMODIFIED

DERIVATIVES, or MODIFICATIONS.

(b) Under a separate implementing

letter to this Agreement (or an

agreement at least as protective of the

PROVIDER’s rights), the RECIPIENT

may distribute MODIFICATIONS to

NONPROFIT ORGANIZATION(S) for

research and teaching purposes only.

(c) Without written consent from the

PROVIDER, the RECIPIENT and/or the

RECIPIENT SCIENTIST may NOT

provide MODIFICATIONS for

COMMERCIAL PURPOSES. It is

recognized by the RECIPIENT that such

COMMERCIAL PURPOSES may require

a commercial license from the

PROVIDER and the PROVIDER has no

obligation to grant a commercial license

to its ownership interest in the

MATERIAL incorporated in the

MODIFICATIONS. Nothing in this

paragraph, however, shall prevent the

RECIPIENT from granting commercial

licenses under the RECIPIENT’s

intellectual property rights claiming

such MODIFICATIONS, or methods of

their manufacture or their use.

6. The RECIPIENT acknowledges that

the MATERIAL is or may be the subject

of a patent application. Except as

provided in this Agreement, no express

or implied licenses or other rights are

provided to the RECIPIENT under any

patents, patent applications, trade

secrets or other proprietary rights of the

PROVIDER, including any altered forms

of the MATERIAL made by the

PROVIDER. In particular, no express or

implied licenses or other rights are

provided to use the MATERIAL,

MODIFICATIONS, or any related

patents of the PROVIDER for

COMMERCIAL PURPOSES.

7. If the RECIPIENT desires to use or

license the MATERIAL or

MODIFICATIONS for COMMERCIAL

PURPOSES, the RECIPIENT agrees, in

advance of such use, to negotiate in

good faith with the PROVIDER to

establish the terms of a commercial

license. It is understood by the

RECIPIENT that the PROVIDER shall

have no obligation to grant such a

license to the RECIPIENT, and may

grant exclusive or non-exclusive

commercial licenses to others, or sell or

assign all or part of the rights in the

MATERIAL to any third party(ies),

subject to any pre-existing rights held by

others and obligations to the Federal

Government.

8. The RECIPIENT is free to file patent

application(s) claiming inventions made

by the RECIPIENT through the use of

the MATERIAL but agrees to notify the

PROVIDER upon filing a patent

application claiming MODIFICATIONS

or method(s) of manufacture or use(s) of

the MATERIAL.

9. Any MATERIAL delivered

pursuant to this Agreement is

understood to be experimental in nature

and may have hazardous properties. The

PROVIDER MAKES NO

REPRESENTATIONS AND EXTENDS

NO WARRANTIES OF ANY KIND,

EITHER EXPRESSED OR IMPLIED.

THERE ARE NO EXPRESS OR IMPLIED

WARRANTIES OF

MERCHANTABILITY OR FITNESS FOR

A PARTICULAR PURPOSE, OR THAT

THE USE OF THE MATERIAL WILL

NOT INFRINGE ANY PATENT,

COPYRIGHT, TRADEMARK, OR

OTHER PROPRIETARY RIGHTS.

10. Except to the extent prohibited by

law, the RECIPIENT assumes all liability

for damages which may arise from its

use, storage or disposal of the

MATERIAL. The PROVIDER will not be

liable to the RECIPIENT for any loss,

claim or demand made by the

RECIPIENT, or made against the

RECIPIENT by any other party, due to

or arising from the use of the

MATERIAL by the RECIPIENT, except

to the extent permitted by law when

caused by the gross negligence or willful

misconduct of the PROVIDER.

11. This agreement shall not be

interpreted to prevent or delay

publication of research findings

resulting from the use of the MATERIAL

or the MODIFICATIONS. The

RECIPIENT SCIENTIST agrees to

provide appropriate acknowledgement

of the source of the MATERIAL in all

publications.

12. The RECIPIENT agrees to use the

MATERIAL in compliance with all

applicable statutes and regulations,

including Public Health Service and

National Institutes of Health regulations

and guidelines such as, for example,

those relating to research involving the

use of animals or recombinant DNA.

13. This Agreement will terminate on

the earliest of the following dates: (a)

When the MATERIAL becomes

generally available from third parties,

for example, through reagent catalogs or

public depositories, or (b) on

completion of the RECIPIENT’s current

research with the MATERIAL, or (c) on

thirty (30) days written notice by either

party to the other, or (d) on the date

specified in an implementing letter,

provided that:

(i) If termination should occur under

13(a), the RECIPIENT shall be bound to

the PROVIDER by the least restrictive

terms applicable to the MATERIAL

obtained from the then-available

sources; and

(ii) If termination should occur under

13 (b) or (d) above, the RECIPIENT will

discontinue its use of the MATERIAL

and will, upon direction of the

PROVIDER, return or destroy any

remaining MATERIAL. The RECIPIENT,

at its discretion, will also either destroy

the MODIFICATIONS or remain bound

by the terms of this agreement as they

apply to MODIFICATIONS; and

(iii) In the event the PROVIDER

terminates this Agreement under 13(c)

other than for breach of this Agreement

or for cause such as an imminent health

risk or patent infringement, the

PROVIDER will defer the effective date

of termination for a period of up to one

year, upon request from the RECIPIENT,

to permit completion of research in

progress. Upon the effective date of

termination, or if requested, the deferred

effective date of termination,

RECIPIENT will discontinue its use of

the MATERIAL and will, upon direction

of the PROVIDER, return or destroy any

remaining MATERIAL. The RECIPIENT,

at its discretion, will also either destroy

the MODIFICATIONS or remain bound

by the terms of this agreement as they

apply to MODIFICATIONS.

14. Paragraphs 6, 9, and 10 shall

survive termination.

15. The MATERIAL is provided at no

cost, or with an optional transmittal fee

solely to reimburse the PROVIDER for

its preparation and distribution costs. If

a fee is requested by the PROVIDER, the

amount will be indicated in an

implementing letter.

Implementing Letter

The purpose of this letter is to provide

a record of the biological material

transfer, to memorialize the agreement

between the PROVIDER SCIENTIST

(identified below) and the RECIPIENT

SCIENTIST (identified below) to abide

by all terms and conditions of the

Uniform Biological Material Transfer
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Notices 12775

1 In addition to persons who meet all

requirements of 45 CFR 400.43, ‘‘Requirements for

documentation of refugee status,’’ eligibility for

Continued

Agreement (‘‘UBMTA’’) March 8, 1995,

and to certify that the RECIPIENT

(identified below) organization has

accepted and signed an unmodified

copy of the UBMTA. The RECIPIENT

organization’s Authorized Official also

will sign this letter if the RECIPIENT

SCIENTIST is not authorized to certify

on behalf of the RECIPIENT

organization. The RECIPIENT

SCIENTIST (and the Authorized Official

of RECIPIENT, if necessary) should sign

both copies of this letter and return one

signed copy to the PROVIDER. The

PROVIDER SCIENTIST will forward the

material to the RECIPIENT SCIENTIST

upon receipt of the signed copy from the

RECIPIENT organization.

Please fill in all of the blank lines

below:

1. PROVIDER: Organization providing the

ORIGINAL MATERIAL:

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

2. RECIPIENT: Organization receiving the

ORIGINAL MATERIAL:

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

3. ORIGINAL MATERIAL (Enter description):

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

4. Termination date for this letter (optional):

5. Transmittal Fee to reimburse the

PROVIDER for preparation and

distribution costs (optional).

Amount: llllllllllllllll

This Implementing Letter is effective when

signed by all parties. The parties executing

this Implementing Letter certify that their

respective organizations have accepted and

signed an unmodified copy of the UBMTA,

and further agree to be bound by its terms,

for the transfer specified above.

PROVIDER SCIENTIST

Name: lllllllllllllllll

Title: llllllllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

RECIPIENT SCIENTIST

Name: lllllllllllllllll

Title: llllllllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

RECIPIENT ORGANIZATION

CERTIFICATION

Certification: I hereby certify that the

RECIPIENT organization has accepted and

signed an unmodified copy of the UBMTA

(May be the RECIPIENT SCIENTIST if

authorized by the RECIPIENT organization):

Authorized Official: lllllllllll

Title: llllllllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

Simple Letter Agreement for Transfer of

Non-Proprietary Biological Material

PROVIDER

Authorized Official: lllllllllll

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

RECIPIENT

Authorized Official: lllllllllll

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

In response to the RECIPIENT’s request for

the BIOLOGICAL MATERIAL identified as

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

the PROVIDER asks that the RECIPIENT and

the RECIPIENT SCIENTIST agree to the

following before the RECIPIENT receives the

BIOLOGICAL MATERIAL:

1. The above BIOLOGICAL MATERIAL is

the property of the PROVIDER and is made

available as a service to the research

community.

2. The BIOLOGICAL MATERIAL will be

used for teaching and academic research

purposes only.

3. The BIOLOGICAL MATERIAL will not

be further distributed to others without the

PROVIDER’s written consent. The

RECIPIENT shall refer any request for the

BIOLOGICAL MATERIAL to the PROVIDER.

To the extent supplies are available, the

PROVIDER or the PROVIDER SCIENTIST

agrees to make the BIOLOGICAL MATERIAL

available, under a separate Simple Letter

Agreement, to other scientists (at least those

at nonprofit organizations or government

agencies) who wish to replicate the

RECIPIENT SCIENTIST’s research.

4. The RECIPIENT agrees to acknowledge

the source of the BIOLOGICAL MATERIAL

in any publications reporting use of it.

5. Any BIOLOGICAL MATERIAL delivered

pursuant to this Simple Letter Agreement is

understood to be experimental in nature and

may have hazardous properties. The

PROVIDER MAKES NO REPRESENTATIONS

AND EXTENDS NO WARRANTIES OF ANY

KIND, EITHER EXPRESSED OR IMPLIED.

THERE ARE NO EXPRESS OR IMPLIED

WARRANTIES OF MERCHANTABILITY OR

FITNESS FOR A PARTICULAR PURPOSE,

OR THAT THE USE OF THE BIOLOGICAL

MATERIAL WILL NOT INFRINGE ANY

PATENT, COPYRIGHT, TRADEMARK, OR

OTHER PROPRIETARY RIGHTS. Except to

the extent prohibited by law, the RECIPIENT

assumes all liability for damages which may

arise from its use, storage or disposal of the

BIOLOGICAL MATERIAL. The PROVIDER

will not be liable to the RECIPIENT for any

loss, claim or demand made by the

RECIPIENT, or made against the RECIPIENT

by any other party, due to or arising from the

use of the MATERIAL by the RECIPIENT,

except to the extent permitted by law when

caused by the gross negligence or willful

misconduct of the PROVIDER.

6. The RECIPIENT agrees to use the

BIOLOGICAL MATERIAL in compliance

with all applicable statutes and regulations,

including, for example, those relating to

research involving the use of human and

animal subjects or recombinant DNA.

7. The BIOLOGICAL MATERIAL is

provided at no cost, or with an optional

transmittal fee solely to reimburse the

PROVIDER for its preparation and

distribution costs. If a fee is requested, the

amount will be indicated here: llll

The RECIPIENT and the RECIPIENT

SCIENTIST should sign both copies of this

letter and return one signed copy to the

PROVIDER SCIENTIST. The PROVIDER will

then forward the BIOLOGICAL MATERIAL.

PROVIDER SCIENTIST

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

Name: lllllllllllllllll

Title: llllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

RECIPIENT SCIENTIST

Organization: llllllllllllll

Address: llllllllllllllll

lllllllllllllllllllll

Name: lllllllllllllllll

Title: llllllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

RECIPIENT ORGANIZATION APPROVAL

Authorized Official: lllllllllll

Title: llllllllllllllllll

Address: llllllllllllllll

Signature: llllllllllllllll

Date: llllllllllllllllll

[FR Doc. 95–5644 Filed 3–7–95; 8:45 am]

BILLING CODE 4140–01–P

Office of Refugee Resettlement

Refugee Resettlement Program:

Proposed Allocations to States of FY

1995 Funds for Refugee Social

Services and for Refugees Who Are

Former Political Prisoners From

Vietnam

AGENCY: Office of Refugee Resettlement

(ORR), ACF, HHS.

ACTION: Notice of proposed allocations

to States of FY 1995 funds for refugee 1